Mitral valve leaflet repair system

Abstract

Aspects of the present disclosure relate to apparatuses, systems, and methods for cardiac device anchoring, and more particularly to entering and anchoring in a pericardial space.

Description

Incorporation by reference of any priority applications

[0001] This application claims priority to U.S. Provisional Application No. 63 / 182,727, filed October 26, 2022, the entire disclosure of which is hereby incorporated by reference herein for all purposes.

[0002] Any and all applications for which foreign or domestic priority claims are identified in the PCT Request filed herewith are hereby incorporated by reference herein. Technical Field

[0003] The present disclosure generally relates to cardiac device anchoring and, more particularly, to devices, systems, and methods including devices that enter and anchor in the pericardial space. Background Art

[0004] There is a need to anchor medical devices in the chambers of the heart. Typically, these devices may have anchors that embed in the myocardium (membrane). There is still a need for a safer anchoring system for such devices. Summary of the Invention

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

[0006] According to one example (“Example 1”), an anchoring system includes an anchor and a tether coupled to the anchor, the anchor being operable to have a small profile in a first position and a larger profile in a second position. The anchor is operable to advance from a cardiac chamber of the heart through a narrow entry passage in the heart wall in the first position into the pericardial space and expand in the pericardial space to a size greater than the narrow entry passage in the second position.

[0007] According to another example (“Example 2”), an anchoring method includes advancing a guide wire into the heart until adjacent to the heart wall; advancing a needle catheter over the guide wire and through the endocardium and into the myocardium of the heart wall; advancing the guide wire through the needle catheter through the myocardium and through the epicardium (visceral layer of the serous pericardium) into the pericardial space; withdrawing the needle catheter from the guide wire; advancing a catheter over the guide wire and into the pericardial space; separating the pericardium from the heart wall to expand the pericardial space; advancing or advancing an anchoring system over the guide wire, the anchoring system having an anchor portion placed into the pericardial space; deploying the anchor of the anchoring system within the pericardial space and placing the anchor opposite the epicardium; removing the guide wire and / or catheter from the patient, leaving a tether coupled to the anchor in the cardiac chamber.

[0008] According to another example ("Example 3"), an anchoring method includes advancing a guide wire into the femoral vein; advancing the guide wire through the femoral vein and into the right atrium; advancing the guide wire through the septum and into the left atrium; advancing the guide wire through the mitral valve until adjacent to the myocardial wall of the left ventricle; advancing a needle catheter over the guide wire and through the endocardium and into the myocardium of the myocardial wall; advancing the guide wire through the needle catheter through the myocardium and through the epicardium and into the pericardial space; withdrawing the needle catheter from the guide wire; advancing a catheter over the guide wire and into the pericardial space; inflating the pericardium and separating it from the myocardial wall, thereby expanding the pericardial space; advancing or passing an anchoring system over the guide wire or through the catheter, and placing the anchoring portion of the anchoring system into the pericardial space; deploying the anchor of the anchoring system within the pericardial space and positioning the anchor opposite the epicardium; removing the guide wire and / or catheter from the patient, thereby leaving a tether attached to the anchor within the heart chamber.

[0009] According to another example ("Example 4"), an anchoring method includes advancing a guide wire into a needle catheter such that the distal end of the guide wire is adjacent to the distal end of the needle catheter; advancing the distal end of the needle catheter from the ventricle through the endocardium and into the myocardium of the myocardial wall; advancing the distal end of the guide wire through the myocardium and the epicardium and into the pericardial space; and advancing the anchor of the anchoring system over the guide wire and into the pericardial space.

[0010] According to another example ("Example 5"), an anchoring method includes optionally advancing an optional support catheter into the heart until adjacent to or against the myocardial wall; advancing an anchor catheter alone or through the optional support catheter and placing it in a push-fit engagement against or adjacent to the myocardial wall; advancing a guide wire through the anchor catheter, through the endocardium, through the myocardium and through the epicardium (visceral layer of the serous pericardium) of the myocardial wall into the pericardial space; advancing the anchor catheter over the guide wire, through the endocardium, through the myocardium, through the epicardium (visceral layer of the serous pericardium) of the myocardial wall and into the pericardial space; optionally withdrawing the guide wire from the pericardial space; optionally separating the pericardium from the epicardium to expand the pericardial space; advancing or exposing the anchor of the anchoring system through or at or near the distal end of the anchor catheter located within the pericardial space, wherein the anchor is placed into the pericardial space; deploying the anchor of the anchoring system within the pericardial space and positioning the anchor opposite the epicardium; removing the guide wire and / or the anchor catheter and / or the support catheter from the patient, thereby leaving a tether attached to the anchor within the heart chamber.

[0011] According to another example ("Example 6"), an anchoring method includes advancing an anchoring catheter to near or against the heart wall in the ventricle; advancing a guide wire through the anchoring catheter such that the distal end of the guide wire advances through the endocardium and into the myocardium, and through the epicardium into the pericardial space; and advancing the distal end of the anchoring catheter along or on the guide wire and into the pericardial space or near the pericardial space; advancing or exposing an anchor of the anchoring system through or at the distal end of the anchoring catheter located in the pericardial space, wherein the anchor is placed in the pericardial space; deploying the anchor of the anchoring system within the pericardial space and placing the anchor opposite the epicardium; removing the guide wire and / or the anchoring catheter from the patient, thereby leaving the anchor in the heart chamber coupled to the anchoring system on the guide wire and the tether entering the pericardial space.

[0012] According to another example ("Example 7"), a mitral chordal repair system includes a pericardial anchoring system that includes an epicardial anchor having a skirt; a transmyocardial swab; a pericardial anchoring suture that couples the epicardial anchor and the transmyocardial swab; a suture lock; and an anchor socket configured to restrain and dock the suture lock, wherein the epicardial anchor is configured to be convertible between a pre-deployed configuration and a deployed configuration, and further includes at least one leaflet anchor coupled to a leaflet anchor suture, wherein the suture lock is configured to secure the pericardial anchoring suture and the leaflet anchor suture.

[0013] Another example of the mitral chordal repair system according to Example 7 ("Example 8"), wherein the epicardial anchor is configured to form a disk shape in the deployed configuration.

[0014] Another example of the mitral chordal repair system according to Example 7 ("Example 9"), 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] Another example of the mitral chordal repair system according to Example 7 ("Example 10"), wherein the pre-deployed configuration includes an elongated configuration, and wherein the deployed configuration includes a compressed configuration.

[0016] Another example of the mitral chordal repair system according to Example 7 ("Example 11"), wherein the pre-deployed configuration includes an elongated configuration, and wherein the deployed configuration includes a coiled configuration.

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

[0018] Another example of the mitral chordal repair system according to Example 7 (“Example 13”), wherein the epicardial anchor further includes a wire frame, and wherein the wire frame is covered by a skirt.

[0019] Another example of the mitral chordal repair system according to Example 13 (“Example 14”), wherein the wire frame of the epicardial anchor has shape memory properties and is set to an expanded configuration.

[0020] Another example of the mitral chordal repair system according to Example 13 (“Example 15”), wherein the skirt is configured to slidably receive a pericardial anchor suture, and wherein the pericardial anchor suture is operable to be tensioned to tighten the skirt into an expanded configuration.

[0021] Another example of the mitral chordal repair system according to Example 13 (“Example 16”), wherein the skirt of the epicardial anchor is coupled to the wire frame along an edge of a defined length, wherein the skirt includes a plurality of holes along an edge of the skirt opposite the wire frame, wherein the pericardial anchor suture is alternately woven through the plurality of holes, and wherein the pericardial anchor suture is operable to be tensioned to tighten the skirt into an expanded configuration.

[0022] Another example of the mitral chordal repair system according to Example 13 (“Example 17”), wherein the wire frame of the epicardial anchor further includes a proximal leg, and wherein the proximal leg is configured to remain straight and positioned at the center of the epicardial anchor in an expanded configuration.

[0023] Another example of the mitral chordal repair system according to Example 17 (“Example 18”), wherein a transmyocardial swab extends from the proximal leg of the epicardial anchor.

[0024] Another example of the mitral chordal repair system according to Example 17 (“Example 19”), wherein the proximal leg includes two folded portions of the same wire such that the two portions are parallel to each other.

[0025] Another example of the mitral chordal repair system according to Example 7 (“Example 20”), wherein the epicardial anchor is convertible between a pre-expanded configuration and an expanded configuration at least in part due to proximal retraction of the pericardial anchor suture.

[0026] Another example of the mitral chordal repair system according to Example 13 (“Example 21”), wherein the epicardial anchor is convertible between a pre-expanded configuration and an expanded configuration at least in part due to the shape memory properties of the wire frame set to an expanded configuration.

[0027] Another example of the mitral chordal repair system according to Example 7 (“Example 22”), wherein both the first end of the wire frame and the second end of the wire frame include anti-traumatic ends.

[0028] Another example of the mitral chordal repair system according to Example 7 (“Example 23”), wherein the transmyocardial swab includes a membrane having a tubular structure.

[0029] Another example of the mitral chordal repair system according to Example 23 (“Example 24”), wherein the pericardial anchoring sutures are woven to pass through a plurality of holes that pass through the membrane of the transmyocardial swab.

[0030] Another example of the mitral chordal repair system according to Example 7 (“Example 25”), wherein the anchor socket includes a self-expanding frame covered with a membrane.

[0031] According to another example (“Example 26”), a pericardial anchoring system includes an epicardial anchor having a skirt; a transmyocardial swab extending from a proximal portion of the epicardial anchor; a pericardial anchoring suture connecting the epicardial anchor and the transmyocardial swab; a suture lock configured to secure the pericardial anchoring suture; and an anchor socket configured to restrain and dock the suture lock, wherein the epicardial anchor is configured to be convertible between a pre-deployed configuration and a deployed configuration.

[0032] Another example of the pericardial anchoring system according to Example 26 (“Example 27”), wherein the epicardial anchor is configured to form a disk shape in the deployed configuration.

[0033] Another example of the pericardial anchoring system according to Example 26 (“Example 28”), 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] Another example of the pericardial anchoring system according to Example 26 (“Example 29”), wherein the pre-deployed configuration includes an elongated configuration, and wherein the deployed configuration includes a compressed configuration.

[0035] Another example of the pericardial anchoring system according to Example 26 (“Example 30”), wherein the pre-deployed configuration includes an elongated configuration, and wherein the deployed configuration includes a coiled configuration.

[0036] Another example of the pericardial anchoring system according to Example 26 (“Example 31”), wherein the epicardial anchor has a free end in the pre-deployed configuration, and wherein the epicardial anchor is configured to coil starting from the free end of the epicardial anchor to form the deployed configuration.

[0037] Another example of the pericardial anchoring system according to Example 26 (“Example 32”), wherein the epicardial anchor further includes a wire frame, and wherein the wire frame is covered by the skirt.

[0038] Another example of the pericardial anchoring system according to Example 32 (“Example 33”), wherein the wire frame of the epicardial anchor has shape memory properties and is set to an expanded configuration.

[0039] Another example of the pericardial anchoring system according to Example 26 (“Example 34”), wherein the skirt is configured to slidably receive a pericardial anchor suture, and wherein the pericardial anchor suture is operable to be tensioned to tighten the skirt into an expanded configuration.

[0040] Another example of the pericardial anchoring system according to Example 32 (“Example 35”), wherein the skirt of the epicardial anchor is joined to the wire frame along an edge of a defined length, wherein the skirt includes a plurality of holes along an edge of the skirt opposite the wire frame, wherein the pericardial anchor suture is alternately woven through the plurality of holes, and wherein the pericardial anchor suture is operable to be tensioned to tighten the skirt into an expanded configuration.

[0041] Another example of the pericardial anchoring system according to Example 32 (“Example 36”), wherein the wire frame of the epicardial anchor further includes a proximal leg, wherein the proximal leg is configured to remain straight and is positioned at the center of the epicardial anchor in an expanded configuration.

[0042] Another example of the pericardial anchoring system according to Example 36 (“Example 37”), wherein the transmyocardial swab extends from the proximal leg of the epicardial anchor.

[0043] Another example of the pericardial anchoring system according to Example 36 (“Example 38”), wherein the proximal leg includes two folded portions of the same wire such that the two portions are parallel to each other.

[0044] Another example of the pericardial anchoring system according to Example 36 (“Example 39”), wherein the epicardial anchor is convertible between a pre-expanded configuration and an expanded configuration at least in part due to proximal retraction of the pericardial anchor suture.

[0045] Another example of the pericardial anchoring system according to Example 32 (“Example 40”), wherein the epicardial anchor is convertible between a pre-expanded configuration and an expanded configuration at least in part due to the shape memory properties of the wire frame set to an expanded configuration.

[0046] Another example of the pericardial anchoring system according to Example 32 (“Example 41”), wherein both the first end of the wire frame and the second end of the wire frame include atraumatic ends.

[0047] Another example of the pericardial anchoring system according to Example 41 (“Example 42”), 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.

[0048] Another example of the pericardial anchoring system according to Example 26 (“Example 43”), wherein the transmyocardial swab includes a membrane having a tubular structure.

[0049] Another example of the pericardial anchoring system according to Example 23 (“Example 44”), wherein the pericardial anchoring suture is woven to pass through a plurality of holes that pass through the membrane of the transmyocardial swab.

[0050] According to another example (“Example 45”), an epicardial anchor includes: a skirt; and a pericardial anchoring suture coupled to the skirt, wherein the epicardial anchor is configured to be convertible between a pre-deployed configuration and a deployed configuration.

[0051] Another example of the epicardial anchor according to Example 45 (“Example 46”), wherein the epicardial anchor is configured to form a disk shape in the deployed configuration.

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

[0053] Another example of the epicardial anchor according to Example 45 (“Example 48”), wherein the pre-deployed configuration includes an elongated configuration, and wherein the deployed configuration includes a compressed configuration.

[0054] Another example of the epicardial anchor according to Example 45 (“Example 49”), wherein the pre-deployed configuration includes an elongated configuration, and wherein the deployed configuration includes a coiled configuration.

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

[0056] Another example of the epicardial anchor according to Example 45 (“Example 51”), wherein the epicardial anchor further includes a wire frame, and wherein the wire frame is covered by the skirt.

[0057] Another example of the epicardial anchor according to Example 45 (“Example 52”), wherein the wire frame of the epicardial anchor has shape memory properties, and its shape is set to the deployed configuration.

[0058] Another example of the epicardial anchor according to Example 51 (“Example 53”), wherein the skirt is configured to slidably receive the pericardial anchoring suture, and wherein the pericardial anchoring suture is operable to be tensioned to tighten the skirt into the deployed configuration.

[0059] Another example of an epicardial anchor according to Example 51 (“Example 54”), wherein the skirt of the epicardial anchor is coupled to the wire frame along an edge of a defined length, wherein the skirt includes a plurality of holes along an edge of the skirt opposite the wire frame, wherein the pericardial anchor sutures are alternately woven through the plurality of holes, and wherein the pericardial anchor sutures are operable to be tensioned to tighten the skirt into a deployed configuration.

[0060] Another example of an epicardial anchor according to Example 51 (“Example 55”), wherein the wire frame of the epicardial anchor further includes a proximal leg, wherein the proximal leg is configured to remain straight and positioned at the center of the epicardial anchor in a deployed configuration.

[0061] Another example of an epicardial anchor according to Example 55 (“Example 56”), wherein the proximal leg includes two folded portions of the same wire such that the two portions are parallel to each other.

[0062] Another example of an epicardial anchor according to Example 55 (“Example 57”), wherein the epicardial anchor is convertible between a pre-deployed configuration and a deployed configuration at least in part due to proximal retraction of the pericardial anchor sutures.

[0063] Another example of an epicardial anchor according to Example 51 (“Example 58”), wherein the epicardial anchor is convertible between a pre-deployed configuration and a deployed configuration at least in part due to the shape memory properties of the wire frame shaped to the deployed configuration.

[0064] Another example of an epicardial anchor according to Example 51 (“Example 59”), wherein both the first end of the wire frame and the second end of the wire frame include atraumatic ends.

[0065] Another example of an epicardial anchor according to Example 64 (“Example 60”), 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.

[0066] According to another example (“Example 61”), a method of anchoring a pericardial anchor system, comprising: advancing an epicardial anchor in a pre-deployed configuration constrained within an anchor catheter into the pericardial space of the heart; advancing the anchor catheter tangentially in the pericardial space a predetermined distance to allow the epicardial anchor in the pre-deployed configuration to escape; and retracting the anchor catheter to at least partially deploy the epicardial anchor in a deployed configuration in the pericardial space.

[0067] Another example of the method of anchoring a pericardial anchor system according to Example 61 (“Example 62”), wherein the predetermined distance includes at least 10 cm.

[0068] Another example of the method of an anchoring pericardial anchoring system according to Example 61 ("Example 63"), wherein the anchoring catheter is configured to travel in the pericardial space in a medial-lateral direction and / or in a superior-inferior direction.

[0069] Another example of the method of an anchoring pericardial anchoring system according to Example 61 ("Example 64"), further comprising positioning the proximal leg of the epicardial anchor between the epicardium and the distal end of the anchoring catheter to maintain the position of the epicardial anchor within the pericardial space.

[0070] Another example of the method of an anchoring pericardial anchoring system according to Example 61 ("Example 65"), further comprising applying tension to the pericardial anchoring suture of the pericardial anchoring system to at least partially convert the epicardial anchor to a deployed configuration.

[0071] Another example of the method of an anchoring pericardial anchoring system according to Example 61 ("Example 66"), wherein the epicardial anchor is further converted to a deployed configuration at least in part due to the shape memory properties of the wire frame of the epicardial anchor that is shaped to the deployed configuration.

[0072] According to another example ("Example 67"), a method of an anchoring pericardial anchoring system includes: advancing a support sheath until and against the heart wall in the ventricle; and advancing a guide wire through the support sheath such that the distal end of the guide wire advances through the endocardium, myocardium, and epicardium and into the pericardial space; advancing an anchor sheath and a guide wire sheath together through the support sheath and advancing over the guide wire and into the pericardial space to form a perforation through the endocardium, myocardium, and epicardium; maintaining the position of the guide wire sheath while retracting the anchor sheath and the support sheath together to deploy the epicardial anchor of the pericardial anchoring system in the pericardial space, wherein the epicardial anchor is in a pre-deployed configuration when positioned within the anchor sheath; maintaining the position of the anchor sheath while retracting the guide wire sheath to form a T-bar between the proximal leg of the wire frame of the epicardial anchor and the distal end of the anchor sheath; retracting the support sheath, the anchor sheath, and the guide wire sheath together until the proximal leg is positioned against the perforation in the epicardium; maintaining the position of the guide wire sheath and retracting the anchor sheath and the support sheath together to deploy the epicardial anchor; applying tension to the pericardial anchoring suture of the pericardial anchoring system to at least partially convert the epicardial anchor to a deployed configuration.

[0073] Another example of the method of an anchoring pericardial anchoring system according to Example 67 ("Example 68"), wherein the epicardial anchor is further converted to a deployed configuration at least in part due to the shape memory properties of the wire frame that is shaped to the deployed configuration.

[0074] Another example of the method of the anchored pericardial anchor system according to Example 67 (“Example 69”) further includes maintaining the position of the guide wire sheath and retracting the support sheath and the anchor sheath to deploy the transmyocardial swab and the anchor socket of the pericardial anchor system, wherein a first portion of the transmyocardial swab is positioned within the perforation of the epicardium, myocardium, and endocardium, and a second portion of the transmyocardial swab extends proximally from the perforation of the endocardium.

[0075] Another example of the method of the anchored pericardial anchor system according to Example 67 (“Example 70”) further includes folding the second portion of the transmyocardial swab against the perforation of the endocardium.

[0076] Another example of the method of the anchored pericardial anchor system according to Example 67 (“Example 71”) further includes advancing a suture lock into the anchor socket and advancing the suture lock positioned within the anchor socket toward the endocardium to fold the second portion of the transmyocardial swab.

[0077] Another example of the method of the anchored pericardial anchor system according to Example 68 (“Example 72”), wherein the proximal leg of the epicardial anchor covered with the membrane is configured to seal the perforation of the epicardium, wherein the first portion of the transmyocardial swab is configured to seal the perforation of the myocardium, and wherein the folded second portion of the transmyocardial swab is configured to seal the perforation of the endocardium. According to one embodiment, a pericardial access and fixation tool, referred to herein as a tool, is provided that is operable to deploy into the myocardium and extend from the ventricular side of the heart into the pericardial space.

[0078] According to another example (“Example 73”), a tool for placement in a heart wall and a pericardial space, the tool being operable to provide a passage from a chamber of the heart into the pericardial space and / or operable to act as an anchor for a device coupled thereto, the tool including 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 space, the head including a movable element operable to move from a small-profile pre-deployed configuration to a large-profile deployed configuration, the head defining an aperture that is in fluid communication with the lumen to define and access a passage that is operable to provide a fluid passage between the ventricle and the pericardial space; and a base, further including a retaining member operable to hold the base in the heart wall.

[0079] Another example of the tool according to Example 73 (“Example 74”), wherein when the movable element reaches the large profile in the deployed configuration, the movable element is operable to support the parietal pericardium, and wherein the retaining member cooperates to engage the movable element adjacent to the parietal pericardium.

[0080] Another example of a tool according to Examples 73 and 74 (“Example 75”), the tool of Examples 1 and 2, wherein the movable element includes a dilator member operable to abut the pericardium to expand the pericardial space.

[0081] Another example of a tool according to Examples 73 and 74 (“Example 76”), wherein the aperture is operable to discharge or withdraw fluid or gas from the pericardial space using a device in communication with the lumen.

[0082] Another example of a tool according to Example 73 (“Example 77”), wherein the aperture is operable as a pressure port that is operable to measure pressure using a pressure sensing device.

[0083] Another example of a tool according to any one of Examples 73-77 (“Example 78”), wherein the access channel is operable to receive a device and allow the device to pass through the access channel between the ventricular side of the heart and the pericardial space.

[0084] Another example of a tool according to any one of Examples 73-77 (“Example 79”), wherein the aperture is operable to elastically deform between an open configuration and a closed configuration, wherein in the closed configuration, the access channel is occluded to prevent fluid from passing through the access channel.

[0085] Another example of a tool according to any one of Examples 73-77 (“Example 80”), wherein the head further includes an occlusion element operable to move elastically between an open position and a closed position, wherein in the closed position, the access channel is occluded to prevent fluid from passing through the access channel.

[0086] Another example of a tool according to any one of Examples 73-77 (“Example 81”), further including an occlusion plug operable to be placed in the access channel to occlude the access channel to prevent fluid from passing through the access channel.

[0087] Another example of a tool according to any one of Examples 73-77 (“Example 82”), wherein the tool is operable to couple to the tissue of the heart or other devices.

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

[0089] Another example of the method of the implantation tool according to Example 83 (“Example 84”), characterized in that the delivery system further comprises a guide wire and / or a needle, and the method comprises advancing the guide wire or the needle through the delivery catheter and extending through the tool into the myocardium and into the pericardial space, and advancing the tool over the guide wire or the needle.

[0090] According to another example (“Example 85”), a method for mitral chordal repair comprises: locking a suture in an anchor socket; connecting a pericardial anchor suture integral with the 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 at least one leaflet anchor suture to a predetermined tension (predetermined amount of tension) based on the position of the suture lock relative to each of the at least one leaflet anchor sutures; and locking at least one leaflet anchor suture.

[0091] According to another example (“Example 86”), a method for leaflet anchoring comprises: providing a leaflet anchoring system comprising: at least one leaflet anchor configured to pass through the mitral valve leaflet; and at least one leaflet suture configured to be integral with at least one leaflet anchor and pass through the mitral valve leaflet; advancing a delivery catheter to the first side of the mitral valve leaflet; advancing a needle through the delivery catheter; extending the needle tip to pierce the mitral valve leaflet; delivering at least one leaflet anchor integral with at least one leaflet suture to the second side of the mitral valve leaflet; individually tensioning at least one leaflet suture to a predetermined tension (amount of tension) based on the position of the suture lock; and withdrawing the delivery catheter.

[0092] Another example of the leaflet anchoring method according to Example 86 (“Example 87”) further comprises locking at least one leaflet suture to the suture lock to maintain the tension of at least one leaflet suture.

[0093] Another example of the leaflet anchoring method according to Example 86 (“Example 88”), wherein at least one leaflet anchor is a swab comprising at least one hole configured to be integral with at least one leaflet suture.

[0094] Another example of the leaflet anchoring method according to Example 86 (“Example 89”), wherein at least one leaflet anchor is configured to form a compression structure when tension is applied to at least one leaflet suture.

[0095] Another example of the leaflet anchoring method according to Example 86 (“Example 90”) further comprises compressing at least one leaflet anchor by applying tension to at least one leaflet suture.

[0096] The foregoing examples are merely examples and should not be construed as limiting or otherwise narrowing the scope of any inventive concept provided by the present disclosure in other ways. BRIEF DESCRIPTION OF THE DRAWINGS

[0097] 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, illustrate embodiments, and together with the description are used to explain the principles of the present disclosure.

[0098] Figure 1A is a side view of an anchoring system according to one embodiment;

[0099] Figure 1B is Figure 1A a side view of the anchoring system;

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

[0101] Figure 2B is Figure 2A an enlarged cross-sectional view of the heart;

[0102] Figure 3 is a cross-sectional view of the heart with a guide wire according to an embodiment of a method for providing a pericardial anchoring system;

[0103] Figure 4 is a cross-sectional view of the heart with a guide wire according to an embodiment of a method for providing a pericardial anchoring system;

[0104] Figure 5A is a cross-sectional view of the heart with a guide wire according to an embodiment of a method for providing a pericardial anchoring system;

[0105] Figure 5B is a cross-sectional view of the heart with a guide wire according to an embodiment of a method for providing a pericardial anchoring system;

[0106] Figure 6 is a cross-sectional view of the heart with a guide wire and a needle catheter according to an embodiment of a method for providing a pericardial anchoring system;

[0107] Figure 7 is a cross-sectional view of the heart with a guide wire and a needle catheter according to an embodiment of a method for providing a pericardial anchoring system;

[0108] Figure 8 is a cross-sectional view of the heart with a guide wire and a catheter according to an embodiment of a method for providing a pericardial anchoring system;

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

[0110] Figure 10 is a cross-sectional view of the heart with a catheter and a deployed anchoring system according to an embodiment of a method for providing a pericardial anchoring system;

[0111] Figure 11 A cross-sectional view of a heart with an anchored system that has been deployed, according to an embodiment of a method of providing a pericardial anchoring system;

[0112] Figure 12 A cross-sectional view of a heart with an anchored system that has been deployed using a sealing device, according to an embodiment of a method of providing a pericardial anchoring system;

[0113] Figure 13 A cross-sectional view of a heart with an anchored system that has been deployed using a tether lock, according to an embodiment of a method of providing a pericardial anchoring system;

[0114] Figure 14 A cross-sectional view of a heart with an anchored system that has been deployed and attached to the mitral valve leaflets to prevent prolapse, according to an embodiment of a method of providing a pericardial anchoring system;

[0115] Figure 15 A flowchart of an embodiment of a method of providing a pericardial anchoring system;

[0116] Figure 16 A flowchart of an embodiment of a method of providing a pericardial anchoring system;

[0117] Figure 17 A flowchart of an embodiment of a method of providing a pericardial anchoring system;

[0118] Figure 18 A plan view of an anchoring member system in a pre-deployed configuration according to an embodiment, wherein the wire and skirt are in a straight configuration;

[0119] Figure 19 is according to Figure 18 A plan view of an anchoring member system in a deployed configuration according to an embodiment, wherein the wire and skirt are in a loop configuration; and

[0120] Figure 20 is according to Figure 18 and 19 A perspective cross-sectional view of an anchoring member system deployed in the pericardial space using an anchoring member placed against the epicardium, wherein the tether passes through the endocardium and further includes an optional tether lock located on the opposite side of the endocardium.

[0121] Figure 21 An example of a pericardial anchoring system in a flat open configuration according to an embodiment.

[0122] Figure 22 is Figure 21 An example of a pericardial anchoring system, wherein the pericardial anchor is in a deployed configuration and the transmyocardial swab is in a pre-deployed configuration.

[0123] Figure 23 is of a pericardial anchoring system in a fully deployed configuration Figure 21 and 22 an example of a pericardial anchoring system

[0124] Figure 24 is an example of a wire frame of a pericardial anchor in a deployed configuration according to one embodiment

[0125] Figure 25A is an example of a pericardial anchoring system having a suture lock according to one embodiment

[0126] Figure 25B is an example of a pericardial anchoring system having a T-bar pericardial anchor according to one embodiment

[0127] Figure 26A is an example of a pericardial anchoring system having a frameless pericardial anchor according to one embodiment

[0128] Figure 26B is an example of a pericardial anchoring system having a T-bar and a frameless pericardial anchor according to one embodiment

[0129] Figure 27 is an example of a pericardial anchoring system and a leaflet anchoring system deployed and implanted in the heart according to one embodiment

[0130] Figure 28A is an example of a leaflet anchor implanted in a valve leaflet and a leaflet anchor suture extending between the leaflet anchor and a pericardial anchoring system implanted in the ventricular wall

[0131] Figure 28B is a cross-sectional view of a ventricular wall implanted with a pericardial anchoring system according to one embodiment

[0132] Figure 28C is a view of a pericardial anchor implanted in a pericardial cavity (the pericardium is not shown for clarity)

[0133] Figure 29 is an example of a delivery subsystem of a pericardial anchoring system in a first configuration according to one embodiment

[0134] Figure 30 is of a Figure 29 delivery subsystem of a pericardial anchoring system in a second configuration

[0135] Figure 31 is for Figure 29 and 30 an example of a guide wire sheath of a delivery subsystem of a pericardial anchoring system

[0136] Figure 32 is an example of a delivery subsystem with a pericardial anchoring system according to one embodiment.

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

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

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

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

[0141] Figure 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 anchoring system.

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

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

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

[0145] Figure 40 is a cross-sectional view of a heart wall according to an embodiment of a method for providing a pericardial anchoring system, wherein a guide wire sheath is retracted to deliver a pericardial anchoring system.

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

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

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

[0149] Figure 44 A cross-sectional view of a heart with a needle according to an embodiment of a method of providing a leaflet anchoring system.

[0150] Figure 45 A cross-sectional view of a heart with a needle according to an embodiment of a method of providing a leaflet anchoring system.

[0151] Figure 46 A cross-sectional view of a heart with a delivery subsystem for a leaflet anchoring system withdrawn.

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

[0153] Figure 48A A cross-sectional view of a heart with a suture lock positioned in an anchor socket of a pericardial anchoring system.

[0154] Figure 48B A cross-sectional view of a heart wall with a suture lock positioned in an anchor socket of a pericardial anchoring system.

[0155] Figure 49A A cross-sectional view of a heart with an anchor socket of a pericardial anchoring system positioned against the heart wall.

[0156] Figure 49B A cross-sectional view of a heart wall with a pericardial anchoring system.

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

[0158] Figure 51 A cross-sectional view of a heart where the suture cutter is withdrawn.

[0159] Figure 52 A cross-sectional view of a heart where the delivery catheter is withdrawn.

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

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

[0162] Figure 54A and 54B are a side view and a cross-sectional view of a tool according to an embodiment, respectively.

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

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

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

[0166] Figure 55B is a cross-sectional view of a heart according to one embodiment, showing a tool that traverses the endocardium and myocardium with the assistance of a needle during deployment to be placed in the myocardial and pericardial space.

[0167] Figure 55C is a cross-sectional view of a heart according to one embodiment, showing a tool that traverses the epicardium during deployment to be placed in the myocardial and pericardial space.

[0168] Figure 55D is a cross-sectional view of a heart according to one embodiment, showing a tool that expands the pericardial space during deployment.

[0169] Figure 55E is a cross-sectional view of a heart according to one embodiment, showing a movable element of a tool that expands the pericardial space during deployment.

[0170] Figure 55F is a cross-sectional view of a heart according to one embodiment, showing a movable element of a tool that engages the epicardium and / or pericardium to anchor the tool in the pericardial space.

[0171] Figure 55G is a cross-sectional view of a heart according to one embodiment, showing a movable element of a tool that engages the epicardium and / or pericardium to anchor the tool in the pericardial space.

[0172] Figure 55H is a top view of a head according to one embodiment, showing the placement of a movable element in a deployed configuration.

[0173] Figure 55I is a cross-sectional view of a heart according to one embodiment, showing a tool in a deployed configuration placed in the myocardial and pericardial space.

[0174] Figure 56A1 and 56A2 are a top view and a side view, respectively, of a tool head having a movable element according to one embodiment.

[0175] Figure 56A3 is a side view of a tool head having a movable element according to one embodiment.

[0176] Figure 56A4 is a side view of a tool head having a movable element according to one embodiment.

[0177] Figure 56B1It is a top view of a tool head having a movable element according to an embodiment.

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

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

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

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

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

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

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

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

[0186] Figure 56D2 It is a side view of a tool head having a movable element according to an embodiment. Detailed Description

[0187] Those skilled in the art will readily understand that various aspects of the present disclosure can be implemented by any number of methods and devices configured to perform the intended functions. It should also be noted that the drawings referred to herein are not necessarily drawn to scale and may be exaggerated to illustrate various aspects of the present disclosure, and in this regard, the drawings should not be construed as limiting.

[0188] Although the embodiments herein may be described in conjunction with various principles and concepts, the described embodiments should not be limited by theory. For example, embodiments are described herein in connection with preventing mitral valve leaflet prolapse by means of an anchoring system contained within the pericardial space. However, embodiments within the scope of the present disclosure can be applied to any prosthesis or mechanism having a similar structure and / or function that needs to be anchored within a chamber of the heart.

[0189] Embodiments of the present disclosure include various devices, systems, and methods for sutures or other tethering mechanisms having an anchor located within the pericardial space, where the suture extends through the myocardium and endocardium for coupling to a biological element such as a mitral valve or a prosthesis such as, but not limited to, a sensor or a support structure. The anchor located within and adjacent to the epicardium (visceral layer of the serous pericardium) can have any suitable structure such as, but not limited to, an umbrella element, a swab, a multi-leg support structure, etc. The anchor is operable to have a small profile such that it can pass through a narrow access passage in the heart wall and expand or deploy within the pericardial space to a larger diameter or surface area, and does not pass through a narrow access passage in the cardiac structure. The present disclosure relates to mitral valve repair or replacement, and more generally to methods and devices for mitral valve remodeling, repair, and / or replacement of mitral valve chords to restore normal function of the mitral valve from a malfunction state such as, but not limited to, mitral regurgitation, and mitral valve chords are also referred to as chordae tendineae.

[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" are the space defined by the heart wall and the pericardium therebetween, or the space between the visceral pericardium and the parietal pericardium.

[0192] As used herein, the term "coupling" means to link, connect, attach, adhere, fix, or bind, whether directly or indirectly, whether permanently or temporarily.

[0193] As used herein, the term "pericardial anchor" is used to describe the anchor of a pericardial anchor system. However, the anchor of the pericardial system can also be referred to as an epicardial anchor or an anchor.

[0194] According to one embodiment, and as Figure 17 provided herein, pericardial anchoring is facilitated by a small hollow needle catheter (e.g., 20 - 25 gauge) and a compatible guide wire (e.g., 0.010 inches - 0.018 inches, which is operable to fit through the lumen of the needle catheter). The passage through the heart wall from within the heart chamber is initiated by the needle catheter passing through the endocardium and into the myocardium, and is completed by the guide wire passing through the remainder of the myocardium and through the epicardium. The guide wire is placed into the pericardial space such that the anchor of the anchor system can then be delivered on the guide wire and into the pericardial space.

[0195] Due to the extremely small profile, the risk of adverse events may be reduced, such as being less likely to cause pericardial effusion / pericardial tamponade.

[0196] Using a guide wire instead of a needle catheter to penetrate the epicardium can result in increased safety and, for example, increased ease of procedure by eliminating guesswork / ambiguity about entering the pericardial space that is not too short or too far, as imaging and / or understanding of this space is challenging for pericardial space placement. For example, the selection of guide wire stiffness is optimized at the distal end and along the entire length such that, but not limited to, the distal end is stiff enough to penetrate through the rest of the heart wall and into the pericardial space, yet soft enough to deflect without piercing the pericardium (the serous pericardium and the parietal layer of the fibrous pericardium). The guide wire can be operable to coil within the pericardial space and travel within the pericardial space. Advancement of the distal end of the guide wire within the pericardial space and adjacent to the heart wall can provide evidence to the clinician that the distal end of the guide wire is within the pericardial space.

[0197] Wherein, the outer diameter of the guide wire is only slightly smaller than the inner diameter of the needle, and potential coring out of the heart wall is alleviated or minimized, thereby reducing tissue trauma. The needle catheter and the guide wire can be introduced together with the distal end of the guide wire, which is slightly retracted relative to the distal end of the needle catheter, i.e., nested or in series. After the needle catheter pierces the endocardium, the guide wire can be advanced beyond the distal end of the needle catheter, and the needle catheter provides support for the guide wire.

[0198] It should be understood that there are different ways to advance a small hollow needle catheter and a subsequent nested guide wire to the target location. In one embodiment, the needle catheter can be advanced over a previously placed guide wire during a wire-guided procedure, such as but not limited to advancing from an access port in the femoral vein. In other embodiments, the needle catheter, with or without a nested guide wire, can be advanced through the lumen of a previously placed, steerable or non-steerable sheath, support / guide catheter, etc.

[0199] It should be understood that after the guide wire has passed through the pericardial space, some additional steps may need to be performed before the anchoring system is advanced. By way of example, but not limited to, the use of contrast agents, CO2, microcatheters, various guide wires, support / guide catheters, and other devices, agents, and therapeutic agents can be used for specific purposes. Such devices, agents, and therapeutic agents can be provided to, but not limited to, create a physical space within the pericardial space at the target location, visualize the pericardial space and / or the heart / pericardial structures at the target location, and ensure that a guide wire with sufficient rigidity and the correct diameter is obtained within the pericardium for delivering the anchoring system.

[0200] According to an embodiment, a diagnostic modality can be employed to provide evidence of guiding a guidewire through the heart wall and into the pericardial space. By way of example, such diagnostic modalities can include, but are not limited to, a guidewire attached to an ECG guide (such as a guidewire having a non-conductive coating except at its proximal and distal ends) and a pressure sensing guidewire having a sensing element at its distal end. Data collected from these modalities can provide evidence of guiding the guidewire through the heart wall and into the pericardial space. Pericardial Anchoring System

[0201] Figure 1A and 1B is a side view of an anchoring system 30 that includes an anchor 32 and a tether 34 coupled to the anchor 32. The anchor 32 is operable to have a small profile 33 in a first position 36 and a larger profile 37 in a second position 38. The anchoring system 30 can be used in the heart 2, as Figure 2A and 2B shown. The anchor 32 is operable to advance from a cardiac chamber 6 of the heart 2 through a stenosis in the heart wall 41 into an access channel 12 and into the pericardial space 10 in the first position 36, and expand in the pericardial space 10 to a size greater than the stenosis in the access channel 12 in the second position 38.

[0202] Figure 2A and 2B is a cross-sectional view of the heart 2 and its corresponding anatomical features. Guidewire advancement / insertion

[0203] Figures 3 - 14 is a series of illustrations of a method for providing an anchor 32 in a cardiac chamber 6 according to an embodiment, and Figure 15 is its flowchart. Enter the femoral vein, and advance a guidewire 40 therein. The guidewire 40 advances through the femoral vein and into the right atrium 20, Figure 3 . The guidewire 40 advances through the septum 26 and into the left atrium 24, Figure 4 . The guidewire 40 advances through the mitral valve 8 and advances until adjacent to the heart wall 41 of the left ventricle 22, [[ID=:31]] Figure 5A and 5B . A needle catheter 42 advances on the guidewire 40 and into approximately half of the thickness of the myocardium 13, Figure 6 . A guidewire 40 having a rigid distal end advances through the needle catheter 42, through the epicardium 14 and into the pericardial space 10, Figure 7 . The length of the guidewire advanced into the pericardial space 10 can be minimized. The guidewire can be configured to coil or assume a coiled shape when advanced into the pericardial space 10. Minimizing the length of the guidewire inserted into the pericardial space 10 can be beneficial for maintaining the integrity of the heart wall. A catheter 44 advances on the guidewire 40 and into the pericardial space 10,Figure 8 A gas such as carbon dioxide can be used to expand the pericardium 18 and separate it from the heart wall 41, thereby enlarging the pericardial space 10. The anchoring system 30 can be advanced over the guide wire 40 after removal of the catheter 44, and / or can be advanced through the catheter 44 after removal of the guide wire 40, Figure 9 , or advanced over the guide wire 40 while the guide wire 40 remains within the catheter 44. The anchoring system 30 can benefit from an anchoring system delivery catheter operable to deliver and deploy the anchoring system. The anchor 32 is deployed within the pericardial space 10 and positioned opposite the epicardium 14, Figure 10 . The anchor 32 can engage the epicardium to secure the anchoring system 30 in place. An example of the deployment of the anchor is described in Figure 16 . The anchoring system 30 includes a suture or tether 34 coupled to the anchor 32, where the suture or tether 34 is retained within the heart chamber 6, Figure 11 .

[0204] It is contemplated that once the delivery system, i.e., any guide wire 40 and / or catheter 44, is removed from the heart 2, the heart wall 41 will seal around the suture or tether 34 such that no additional material is required to prevent blood from transferring from the left ventricle into the pericardial space, which could be caused by the formation of the access channel 12. It is contemplated that, optionally, a sealing device 48 can be provided to reduce or eliminate the potential for blood to transfer from the left ventricle into the pericardial space. Such a sealing device 48 can include, but is not limited to, surface texture on the tether 34 to cause a healing response between the tether 34 and the heart wall 41; a swab along the tether 34 that can be used to occlude the access channel 12; an expandable portion or element around the tether 34 and / or the anchor 32 that is operable to close the access channel 12 around the tether 34 and / or the anchor, Figure 12 .

[0205] In some embodiments, a three - level seal may occur upon removal of the delivery system from the access channel. The access channel can be sealed from the inside of the heart wall, from 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 required after removal of the delivery system. In some embodiments, the smaller the delivery system, the easier it is to achieve a three - level seal and restore the heart wall to its pre - injury state.

[0206] In Figure 13 another embodiment shown, a tether lock 35 is advanced over the tether 34 and abuts the endocardium 11. The tether lock is operable to engage the tether 34 and hold firmly to capture the heart wall 41 between the tether lock 35 and the anchor. Such a tether lock 35 can be operable to ensure a pushing engagement of the anchor 32 with the endocardium 11 to prevent its movement, thereby preventing, for example, any subsequent irritation of the pericardium 18.

[0207] As previously provided, the suture or tether 34 can be used for a specific purpose. According to one embodiment, the suture or tether 34 is coupled to the mitral valve leaflets 9 to prevent leaflet prolapse, as Figure 14 shown.

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

[0209] According to another embodiment, the suture or tether 34 can be coupled to a device such as a sensor. Overview of Anchor Deployment

[0210] According to another embodiment, as provided in the flowchart of Figure 16 and with reference to FIGS. 1-14, the anchoring method includes advancing a guide wire 40 into the heart 2 until adjacent to the heart wall 41. The length of the guide wire advanced into the pericardial space 10 can be minimized. The guide wire can be configured to coil or assume a coiled shape when advanced into the pericardial space 10. Minimizing the length of the guide wire inserted into the pericardial space 10 can be beneficial for maintaining the integrity of the heart wall. A catheter 42 is advanced over the guide wire 40 and into approximately half of the thickness 16 of the heart wall 41. The guide wire 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 guide wire 40. A catheter 44 is advanced over the guide wire 40 and into the pericardial space 10. The pericardium 18 is separated from the heart wall 41 to expand the pericardial space 10. The anchoring system 30 is advanced over the guide wire 40 or advanced through the catheter 44, and its anchoring portion 39 is placed into the pericardial space 10. The anchor 32 of the anchoring system 30 is deployed within the pericardial space 10 and placed opposite the epicardium 14. The guide wire 40 and / or the catheter 44 are removed from the patient's body, leaving the tether 34 coupled to the anchor 32 within the heart chamber 6.

[0211] According to another embodiment, the anchoring method includes optionally advancing a support catheter into the heart, close to or reaching and adjacent to or against the heart wall. The anchor catheter is advanced alone or advanced through an optional support catheter and placed near the heart wall or pushed into engagement against the heart wall. A guide wire is advanced through the anchor catheter, through the endocardium, through the myocardium, and through the epicardium (visceral layer of the serous pericardium) of the heart wall into the pericardial space. The anchor catheter is advanced on the guide wire and through the endocardium, through the myocardium, and through the epicardium (visceral layer of the serous pericardium) of the heart wall into the pericardial space. Optionally, the guide wire is withdrawn from the pericardial space. Optionally, the pericardium is separated from the epicardium to expand the pericardial space. The anchor of the anchoring system is advanced or exposed through or at or near the distal end of the anchor catheter located in the pericardial space, wherein the anchor is placed into the pericardial space. The anchor of the anchoring system is deployed within the pericardial space and the anchor is placed opposite the epicardium. The guide wire and / or the anchor catheter and / or the support catheter are removed from the patient, leaving a tether coupled to the anchor in the heart chamber.

[0212] According to another embodiment of the anchoring method, it includes advancing an anchor catheter near the heart wall in the ventricle or until and against the heart wall. A guide wire is advanced through the anchor catheter such that the distal end of the guide wire advances through the endocardium and into the myocardium, through the epicardium and into the pericardial space. The distal end of the anchor catheter advances along or on the guide wire and into the pericardial space or adjacent to the pericardial space. The anchor of the anchoring system is advanced or exposed through or at the distal end of the anchor catheter located in the pericardial space, wherein the anchor is placed in the pericardial space. The anchor of the anchoring system is deployed within the pericardial space and the anchor is placed opposite the epicardium. The guide wire and / or the anchor catheter and / or the support catheter are removed from the patient, leaving a tether that is coupled to the anchor in the heart chamber of the anchoring system on the guide wire and enters the pericardial space. Anchor design

[0213] According to one embodiment, the anchor system 100 includes an anchor 102. Figure 18 is a plan view of the anchor system 100 in a pre-deployed configuration, wherein the wire 110 and the skirt 120 are in a straight configuration. Figure 19 is a plan view of the anchor system 100 in a deployed configuration, wherein the wire 110 and the skirt 120 are in a loop configuration. Figure 20 is a three-dimensional cross-sectional view of the anchor system 100 deployed with the anchor 102 placed against the epicardium 14 in the pericardial space 10, wherein the tether 130 passes through the endocardium 11, and further includes an optional tether lock 140 located on the opposite side of the endocardium 11.

[0214] The anchor 102 includes a wire 110 having a first end 112 of the wire and a second end 114 of the wire. The wire 110 has shape memory characteristics with a shape set to a loop configuration, wherein the first end 112 of the wire is opposite the second end 114 of the wire. The skirt 120 is coupled to the wire 110 along an edge defining a length. A plurality of holes 126 are along an edge of the skirt 120 opposite the wire 110. The tether 130 is alternately woven through the plurality of holes 126, wherein the tether 130 defines a first end 132 of the tether and a second end 134 of the tether. The first end 132 of the tether and the second end 134 of the tether are operable to be tensioned so as to tighten the skirt 120 into a disk shape when the wire 110 is in the loop configuration in the deployed configuration, and wherein the first end 132 of the tether and the second end 134 of the tether can be tensioned so as to straighten the wire 110 into a straight configuration in the pre-deployed configuration.

[0215] According to another embodiment, the anchoring system 100 is configured such that the first end 112 of the wire and the second end 114 of the wire are operable to fixedly couple together when in the loop configuration.

[0216] According to another embodiment, the anchoring 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 so as to prevent the overlap of the first end 112 of the wire and the second end 114 of the wire from exceeding the complete loop of the wire 110 when in the loop configuration.

[0217] According to another embodiment, the anchoring system 100 is configured such that the skirt 120 has tissue ingrowth characteristics on one side and tissue adhesion prevention characteristics on the other side.

[0218] According to another embodiment, the anchoring system 100 further includes a tether lock 140 slidably coupled to the tether 130, the tether lock being operable to slide along the tether 130 and lock in place to capture the heart wall between the tether lock 140 and the anchor 102. Anchoring method

[0219] An anchoring method according to an embodiment includes: providing the anchoring system as described above; advancing a guide wire into the femoral vein; advancing the guide wire through the femoral vein and into the right atrium; advancing the guide wire through the septum and into the left atrium; advancing the guide wire through the mitral valve until reaching and adjacent to the heart wall of the left ventricle; advancing a needle catheter over the guide wire and through the endocardium into the myocardium of the heart wall; advancing the guide wire through the needle catheter through the myocardium and through the epicardium into the pericardial space; withdrawing the needle catheter from the guide wire; advancing a catheter over the guide wire and into the pericardial space; inflating the pericardium and separating it from the heart wall, thereby expanding the pericardial space; advancing the anchoring system over the guide wire or through the catheter, with its anchor placed into the pericardial space; deploying the anchor of the anchoring system within the pericardial space and placing the anchor opposite the epicardium, wherein the anchor is in a straight configuration in a pre-deployed configuration via the tension on the first end and the second end of the tether, and wherein the anchor is in a loop configuration in a deployed configuration via the tension on the first end and the second end of the tether; and removing the guide wire and / or catheter from the patient, thereby leaving the tether connected to the anchor within the heart chamber.

[0220] An anchoring method according to an embodiment includes: providing the anchoring system as described above; advancing a guide wire into the needle catheter such that the distal end of the guide wire is adjacent to the distal end of the needle catheter; advancing the distal end of the needle catheter from the heart chamber through the endocardium and into the myocardium of the heart wall; advancing the distal end of the guide wire through the myocardium and the epicardium and into the pericardial space; and advancing the anchor of the anchoring system over the guide wire and into the pericardial space; and deploying the anchor within the pericardial space, wherein the anchor is in a straight configuration in a pre-deployed configuration via the tension on the first end and the second end of the tether, and wherein the anchor is in a loop configuration in a deployed configuration via the tension on the first end and the second end of the tether.

[0221] An anchoring method according to an embodiment includes: providing the anchoring system as described above; advancing a support catheter into the heart until adjacent to or against the heart wall; advancing an anchor catheter alone or through the support catheter and placing it in a push-fit engagement against the heart wall; advancing a guide wire along or through the anchor catheter, through the endocardium, through the myocardium, and through the epicardium (visceral layer of the serous pericardium) of the heart wall into the pericardial space; advancing the anchor catheter along or on the guide wire and through the endocardium, through the myocardium, and through the epicardium (visceral layer of the serous pericardium) of the heart wall into the pericardial space; advancing or exposing the anchor of the anchoring system through or at the distal end of the anchor catheter in the pericardial space, wherein the anchor is placed in the pericardial space; deploying the anchor of the anchoring system within the pericardial space and placing the anchor opposite the epicardium, wherein the anchor is in a straight configuration in a pre-deployed configuration via tension on a first end and a second end of a tether, and wherein the anchor is in a loop configuration in a deployed configuration via tension on the first end and the second end of the tether; and removing the guide wire and the anchor catheter from the patient, leaving the tether coupled to the anchor in the heart chamber.

[0222] An anchoring method according to an embodiment includes: providing the anchoring system as described above; advancing the anchor catheter until against the heart wall in a ventricle; advancing a guide wire through the anchor catheter such that the distal end of the guide wire advances through the endocardium and into the myocardium, through the epicardium and into the pericardial space; advancing the distal end of the anchor catheter along or on the guide wire and into or adjacent to the pericardial space, advancing or exposing the anchor of the anchoring system through or at the distal end of the anchor catheter located within the pericardial space, wherein the anchor is placed within the pericardial space, deploying the anchor of the anchoring system within the pericardial space and placing the anchor opposite the epicardium, wherein the anchor is placed within the pericardial space; deploying the anchor of the anchoring system within the pericardial space and placing the anchor opposite the epicardium, wherein the anchor is in a straight configuration in a pre-deployed configuration via tension on a first end and a second end of a tether, and wherein the anchor is in a loop configuration in a deployed configuration via tension on the first end and the second end of the tether; and removing the guide wire and the anchor catheter from the patient, leaving the tether connected to the anchor in the heart chamber of the anchoring system, the anchor entering the pericardial space on the guide wire. Loading of the pericardial anchor system

[0223] Figure 21A side view of an example of a ventricular anchoring system or a pericardial anchoring system 200 that is in a flat open configuration before being loaded onto a delivery system. The pericardial anchoring system 200 can be configured to be loaded onto a delivery system and delivered through a catheter. The pericardial anchoring system 200 can include each of a pericardial anchor 220 and a transmyocardial swab 240 in a straight configuration or an elongated configuration. When the pericardial anchoring system 200 is loaded and delivered in a catheter, the pericardial anchoring system can be in an elongated configuration, and the catheter has a small profile suitable for advancing through the catheter lumen, as Figure 29 shown. Figure 22 An example of the pericardial anchoring system 200 is shown, in which the pericardial anchor 220 is in a deployed configuration and the transmyocardial swab 240 is in a pre-deployed configuration. As shown, the pericardial anchor 220 can be in a deployed configuration. The pericardial anchor 220 in the deployed configuration can be compressed, coiled, stuffed, bundled, curled, bent. Figure 23 An example of the pericardial anchoring system 200 in a deployed configuration is shown. As shown, the pericardial anchor 220 can be in a coiled configuration and the transmyocardial swab 240 can be in a folded configuration. Figure 23 Also shown is a leaflet anchor 300 and a leaflet anchor suture 310 coupled to the pericardial anchoring system 200.

[0224] According to one embodiment, the pericardial anchoring system 200 includes a pericardial anchor 220, a transmyocardial swab 240, an anchor socket 260, and a suture lock 270. In some embodiments, the pericardial anchoring system can include any one or a combination of an anchor, a swab, an anchor socket, and a suture lock. The pericardial anchor 220 can be an anchor, at least a portion of which is configured to be positioned in the pericardial space such that the anchor can resist being pulled through a perforation in the heart wall. At least a portion of the pericardial anchor 220 can be embedded in or in contact with cardiac tissue, such as the epicardium of the heart wall. The pericardial anchor 220 can be a pericardial anchor 220 such that it can achieve a disc, loop, or annular configuration in a deployed configuration. The disc, loop, or annular configuration can be flat or non-flat (such as helical or offset shapes). The pericardial anchor 220 can also present a variety of other shapes in the deployed configuration, such as a curved shape, a compressed shape, a bundle, a mass, or a knot. As will be discussed further below, the pericardial anchor 220 can include a wire frame or can be wire-free. The skirt of the anchor having a wire frame

[0225] The pericardial anchor 220 can include a wire or a wire frame 222 coupled to the skirt 230. Figure 24 A plan view of a wire frame 222 in an unconstrained bent configuration according to an embodiment is shown. The wire or wire frame 222 can be made of nitinol, such as platinum-filled nitinol. As Figure 21As shown, the skirt 230 or the membrane can be any suitable biocompatible material, such as but not limited to a fluoropolymer membrane, such as expanded polytetrafluoroethylene (ePTFE) and expanded polyethylene (ePE). The skirt 230 can have properties that are operable to facilitate tissue ingrowth. The material of the skirt 230 can have additional properties such as flexibility and durability to withstand, for example, the deployment process of the disk formation and the dynamic properties of a beating heart. For example, during the formation of the disk shape from a flat pre-deployed position to a curved deployed position, the material of the skirt 230 is capable of resisting breakage or tearing. Additionally, the material of the skirt 230 can have material properties such as high strength and low weight to provide the skirt 230 with the ability to, for example, anchor against tissue and remain stable in the deployed position.

[0226] The skirt 230 can include a material suitable for a particular use. For example, the material of the skirt 230 can be suitably flexible or compliant to facilitate the deployment of the anchor from a flat configuration to a deployed configuration without tearing and / or without unduly restricting the deployment. For example, the material of the skirt can be suitably flexible such that it does not overcome or unduly restrict the spring bias that causes the wire frame to assume a curved configuration. Further, the skirt material can be suitably flexible such that it conforms to the epicardium once deployed. Additionally, the skirt material can be suitably durable to be structurally sound under the dynamic motion of a beating heart for a period of time after deployment.

[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 the terminals of the wire frame 222. The distal eyelet 224 and the proximal eyelet 226 can be the atraumatic ends of the wire frame 222. As Figure 24 shown, the distal eyelet 224 can be located at the end of the wire frame. This can allow the end of the wire frame to be atraumatic to adjacent tissue. For example, the distal eyelet 224 can prevent the end of the wire frame from damaging the tissue that the end of the wire frame may contact. As Figure 24Further shown, the proximal aperture 226 can be adjacent to and spaced from the end of the wire frame 222. This can allow the end of the wire frame to be within the area surrounded by the frame 222. In other words, this can allow the end of the wire frame to be inside the periphery of the frame 222 or protected by the periphery of the frame 222. Additionally, the proximal aperture 226 can prevent the end points of the wire frame from damaging tissue that the end points of the wire frame may contact. The wire frame 222 can have a proximal leg or T-bar proximal leg 228 at the proximal portion of the wire frame 222 in a straight configuration. The proximal leg 228 can be positioned distal to the proximal aperture 226 of the wire frame 222 in a straight configuration. The proximal leg 228 can be a straight portion of the wire frame 222 that remains straight in both the straight and curved configurations, which in this embodiment is in the shape of a loop.

[0228] Compared to the rest of the wire frame 222, the proximal leg 228 can be strengthened, such as to resist tension or load bearing. According to one embodiment, the proximal leg 228 can include two folded portions of the same wire such that they are parallel to each other and can contact each other, and can be joined together. In some embodiments, the proximal leg 228 can have a material property that is harder than the rest of the wire. This advantageously allows the proximal leg 228 to resist bending and remain straight during the deployment of the pericardial anchor 220, such as when against the distal end of the delivery catheter, while the rest of the wire frame 222 can be deployed to form a curved configuration. Additionally, this advantageously allows the operator of the pericardial anchor system 200 to experience enhanced actuation and enhanced tactile feedback when the proximal leg 228 is deployed and retracted. In one embodiment, the proximal leg 228 is configured to remain straight and position the pericardial anchor 220 against the distal end of the delivery catheter 502 and a perforation in the epicardium to hold the pericardial anchor 220 within the pericardial space and prevent the proximal leg 228 from passing through the epicardium or returning to the distal end of the delivery catheter 502 once in the pericardial space. The proximal leg 228 is operable to prevent the pericardial anchor 220 from being pulled proximally through a perforation in the epicardium.

[0229] According to one embodiment, the proximal leg 228 is configured to maintain a straight configuration such that, in combination with the bending bias of the rest of the wire frame 222, it presents a push engagement with the delivery catheter to assist in deploying the pericardial anchor 220. According to another embodiment, the proximal leg 228 is configured to maintain a straight configuration such that, in combination with the bending bias of the rest of the wire frame 222, it presents a profile that is operable to prevent the anchor from passing through a perforation in the epicardium once deployed.

[0230] The skirt portion 230 can be coupled to the wire frame 222 along an edge of a defined length. The wire frame 222 can be positioned at one end or an edge of the skirt portion 230. In one embodiment, a tether or pericardial anchor suture 280 is coupled to an opposite edge of the skirt portion 230. According to another embodiment, a plurality of anchor holes 232 are positioned along an edge of the skirt portion 230 opposite the wire frame 222. The tether or pericardial anchor suture 280 is alternately woven through the plurality of anchor holes 232 and is slidably received therethrough. A first end of the pericardial anchor suture 280 is configured to be fixedly coupled to a first end of the skirt portion 230 at a suture attachment 234. According to one embodiment, the suture attachment 234 can be a reinforced portion of the skirt portion 230, wherein the reinforced portion is reinforced with additional material or added auxiliary material to facilitate and strengthen the coupling. In another embodiment, the reinforced portion can have different material properties, such as but not limited to pressure and / or thermal densification, such as with porous materials. The suture attachment 234 can be located at a distal end or a distal portion of the skirt portion 230. This can advantageously improve the deployment of the pericardial anchor 220 and the holding tension of the pericardial anchor suture 280. According to one embodiment, compared to a more concentrated load at an attachment point at a more proximal location on the skirt portion 230, the suture attachment 234 at the distal end or the distal portion of the skirt portion 230 that cooperatively engages with the anchor holes 232 in the skirt portion 230 results in a predetermined amount of force distribution along the skirt portion 230.

[0231] The entire wire frame 222 can be coupled to the skirt portion 230. In one embodiment, the skirt portion 230 covers the entire wire frame 222, such as, for example, by being located within a fold or hem of the membrane or being embedded within a layer(s) of the membrane, which can improve the stability of the pericardial anchor 220 in the event of breakage or damage to the wire frame 222. The skirt portion 230 that covers the wire frame 222 can additionally prevent the pericardial anchor suture 280 from misrouting or tangling with the wire frame 222, particularly during the transition of the pericardial anchor 220 from a pre-deployed configuration, such as an elongated configuration, to a deployed configuration, such as a curved configuration.

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

[0233] In other embodiments, as an alternative to the wire frame 222, the biasing element may be integrated or incorporated into the skirt 230. The biasing element is operable to bias the skirt 230 into a curved configuration. According to one embodiment, the biasing element may be a densified, embossed, or treated portion of the skirt 230 that is operable to have a biasing portion to convert the pericardial anchor 220 from a pre-deployed configuration to a deployed configuration, such as from an elongated configuration to a curved configuration.

[0234] By applying tension to the suture proximal end 317 of the pericardial anchor suture 280 extending through the skirt 230 and / or the suture distal end 315 of the pericardial anchor suture 280, the pericardial anchor 220 can be maintained in a straight configuration against the bias of the wire frame 222 in the pre-deployed configuration, as Figure 21 shown. The pericardial anchor suture 280 is operable to be tensioned when the wire frame 222 is in the deployed configuration to tighten the skirt 230 into a curved shape, a disk shape, or an annular shape. The pericardial anchor suture 280 is operable to tighten the skirt 230 such that the skirt 230 extends across the curvature of the wire frame 222 to completely cover the central portion defined by the wire frame 222.

[0235] Regardless of whether the skirt 230 has a biasing member such as the wire frame 222, the deployed configuration can primarily achieve configurations such as a T-bar shape, coiled, stuffed, bundled, loop, annular, knotted configurations, etc. The deployed configuration is operable to provide one or more functions, such as but not limited to preventing pulling through a perforation in the heart wall. And / or distributing the load caused by the tension on the suture to a wider area of the blood vessel wall. And / or providing a suitable surface for tissue ingrowth and / or overgrowth in the healing response.

[0236] In some examples, when the pericardial anchor 220 is in the deployed configuration, the suture proximal end 317 of the pericardial anchor suture 280 is tensioned, such as in the proximal direction, to tighten the skirt 230 into a deployed configuration (such as a compressed, coiled, curved, curled, loop, annular, knotted, bundled, or stuffed shape). The biasing force of the biasing member, which is biased to pull the skirt into a curved configuration. The tension on the pericardial anchor suture 280 can assist in the bending of the biasing member and / or assist in ensuring a complete deployed configuration (such as a curved or loop configuration). The pericardial anchor suture 280 can be connected to the skirt 230 in a configuration that minimizes material bundling or entanglement. The pericardial anchor suture 280 can allow the skirt 230 to curl from proximal to distal to minimize material bundling (material aggregation). In some embodiments, the skirt 230 may include a compression portion or the material of the skirt 230 may be folded in a bellows-like manner. The skirt 230 may contain pleats to assist in curling during deployment of the skirt 230. This can allow the skirt 230 to form a desired configuration that abuts and seals the heart wall in a low-profile manner.

[0237] The distribution of the applied tension force can vary according to the deployed configuration of the skirt 230. For example, a bent or curled deployed configuration of the skirt 230 can include a centroidal distribution of the tension force. While a T-bar deployed configuration of the skirt 230 can cause the tension force to be distributed along the perimeter of the skirt 230. The distribution of the tension force affects the resultant force applied by the pericardial anchor 220 to the heart wall to seal tissue once deployed. The pericardial anchor 220 can be in a pre-deployed configuration (such as an elongated configuration) as shown in, for example, Figure 21 to a deployed configuration (such as a coiled configuration) as shown in, for example, Figure 22 and 23 This transition is facilitated at least in part by the tension applied to the pericardial anchor suture 280 or the bias of a biasing element such as the wire frame 222 or both.

[0238] According to one embodiment, as shown in Figure 24 the wire frame 222 has shape memory properties and is shaped set to a bent or loop or annular configuration that elastically biases (spring biases) to the bent configuration when it extends to a straight configuration, such as when in the pre-deployed structure disposed on the delivery system. As shown in Figure 24 when the pericardial anchor 220 is in the deployed state, the T-bar or proximal leg 228 remains straight, and the remainder of the wire frame 222 is biased to conform to the deployed configuration, i.e., the bent configuration in the unconstrained configuration. The T-bar proximal leg 228 can be positioned at the center of the pericardial anchor 220 in the bent configuration in the deployed configuration. The T-bar proximal leg 228 can be positioned to cover the center of the curve defined by the pericardial anchor 220 such that, according to one embodiment, when in the loop configuration, the T-bar proximal leg extends across the diameter of the pericardial anchor 220. 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, the distal portion of the wire frame 222 including the distal eyelets overlaps another portion of the wire frame 222, such as around the perimeter of the pericardial anchor 220 in the deployed state. The distal eyelets 224 can be positioned to cover the perimeter of the pericardial anchor 220 in the deployed configuration. The proximal eyelets 226 can be positioned at or near the end of the T-bar proximal leg 228 or at the double-back portion 229 and cover the perimeter or adjacent perimeter of the pericardial anchor 220 in the deployed configuration. The distal eyelets 224 and the proximal eyelets 226 can provide trauma-free ends of the wire frame 222, such as during the deployment of the pericardial anchor 220 or once the pericardial anchor 220 is implanted into the pericardial space, the trauma-free ends prevent damage to the delivery system and / or adjacent tissue. In other examples, the pericardial anchor 220 can have other types of trauma-free ends instead of eyelets, such as rounded ends or blunt ends. The trauma-free ends can advantageously prevent damage to tissue during implantation or to other parts of the anchor system, such as the skirt 230.

[0239] In some configurations, when the wire frame 222 is in a bent configuration in the deployed configuration, the wire frame 222 can be biased to form a helix. This bias towards the helix can advantageously prevent the wire frame 222 from tangling with itself, other components of the anchoring system, or the implantation region. The helical configuration can assist in allowing the pericardial anchor 220 to transition to a coiled configuration. In some configurations, the wire frame 222 has a bias portion to conform to the pericardial anchor 220, thereby defining a substantially flat disk when in the deployed configuration.

[0240] In other embodiments, as Figure 22 and 23As an alternative to the coiled configuration shown, the pericardial anchor 220 can be transitioned from a pre-deployed configuration (such as an elongated configuration) suitable for a pre-deployed configuration, such as within a catheter, to a deployed configuration (such as a T-shape, loop, coil, bend, compression, bundle, or stuffed configuration) in a variety of ways. For example, the pericardial anchor 220 can begin to bend or coil starting from the free end of the pericardial anchor 220 to form a deployed shape, such as a disc shape. The free end can be the distal end of the pericardial anchor 220, which can be the distal termination of both the pericardial anchor 220 and the pericardial anchor system 200. The coiling that may occur can be partial to form a partial disc shape, can be complete to form a complete disc shape, or can be overlapping to form a complete disc shape. The disc shape can have a low profile so as not to significantly abut the parietal pericardium or otherwise significantly interfere with the pericardium. The size of the disc shape can be configured to operably prevent the pericardial anchor 220 from being pulled through the heart wall via a perforation or passage in the myocardium by the delivery subsystem 400 or the pericardial anchor suture 280. The size of the disc shape can be configured to operably disperse the force acting on the pericardial anchor 220 and the surrounding tissue adjacent thereto in a trauma-free manner, which force is caused by the tension on the remainder of the pericardial anchor system 200. The T-bar pericardial anchor described further below can have a low profile, where the T-bar can be deployed in a linear configuration. The bar can be configured to operably prevent the pericardial anchor 220 from being pulled through the heart wall via a perforation or passage in the myocardium by the delivery subsystem 400 or the pericardial anchor suture 280. In some embodiments, the coiling can form a shape having a greater width or diameter than the pre-deployed configuration. According to other embodiments, the shape of the anchor can define other shapes, such as but not limited to a square, cross, and diamond. The wire frame 222 of the pericardial anchor 220 is operable to straighten and return to a low-profile (small-profile), high-surface area shape, which is advantageous for the 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, which surface area is operable, such as but not limited to, to promote in-growth of tissue and / or distribute the load on the pericardial anchor system 200 over a larger area of the heart surface.

[0241] In some embodiments, the pericardial anchor 220 can be bundled or stuffed to achieve a deployed configuration. For example, the pericardial anchor 220 in an elongated configuration can be folded, compressed, bundled, curled, or stuffed to form a deployed configuration. Swab

[0242] As described above, the pericardial anchoring system 200 may further include a pericardial anchor suture 280. The pericardial anchor suture 280 may extend through each of the pericardial anchor 220 and the transmyocardial swab 240. The pericardial anchor suture 280 may be coupled to the skirt 230 of the pericardial anchor 220, such as but not limited to, by weaving through the skirt 230 of the pericardial anchor 220 or being integrally formed with the skirt 230 of the pericardial anchor 220. As Figure 21 shown, the pericardial anchor suture 280 may be woven through a plurality of anchor holes 232 that pass through the skirt 230. The pericardial anchor suture 280 may extend from the skirt 230 of the pericardial anchor 220 and then be woven through the transmyocardial swab 240. The transmyocardial swab 240 may also include a plurality of swab holes 262, and the pericardial anchor suture 280 may be woven to pass through the plurality of swab holes 262. The pericardial anchor suture 280 may be made of any suitable biocompatible material, such as but not limited to fluoropolymer fibers.

[0243] The pericardial anchoring system 200 may include a swab as disclosed in International Application No. PCT / US2020 / 032054 or International Application No. PCT / US2020 / 032168, which are incorporated herein by reference in their entireties, and various embodiments of the swab disclosed therein. The transmyocardial swab 240 may be tubular, spherical, rectangular, etc. The transmyocardial swab 240 can be used to increase, adjust, augment, expand, and / or extend the surface area of the suture. The transmyocardial swab 240 may include a membrane. The membrane may be a fluoropolymer, which may have tissue ingrowth properties. The membrane of the transmyocardial swab 240 may have a tubular structure. The transmyocardial swab 240 may include a plurality of swab holes 262 that are positioned along the length of the transmyocardial swab 240. The pericardial anchor suture 280 may be woven to pass through the membrane of the transmyocardial swab 240 or integrated into the membrane. As Figure 21 and 22 shown, the pericardial anchor suture 280 may be woven to pass through a plurality of swab holes 262 that pass through the membrane of the transmyocardial swab 240. The pericardial anchor suture 280 may allow the transmyocardial swab 240 to transition from a more straight configuration, such as that shown in Figure 21 to a curved configuration, such as that shown in Figure 23 . For example, tensioning or retracting the pericardial anchor suture 280 can compress the material or fold the material of the transmyocardial swab 240 in an accordion-like manner. In some examples, continuing to apply tension to the pericardial anchor suture 280 may continue to compress or fold the material of the transmyocardial swab 240 in an accordion-like manner. The transmyocardial swab 240 may include pleats to assist in folding during deployment of the transmyocardial swab 240.

[0244] As Figure 21As shown, the pericardial anchor 220 can be positioned at the distal end of the pericardial anchoring system 200 and the transmyocardial swab 240 can be positioned proximally from the pericardial anchor 220. The transmyocardial swab 240 can extend from the proximal leg 228 of the pericardial anchor 220. The transmyocardial swab 240 can be directly laminated or otherwise coupled to the proximal leg 228 of the wire frame 222 of the pericardial anchor 220. This advantageously allows the proximal leg 228 to span a perforation in the epicardium while positioning the transmyocardial swab 240 to pass through perforations in the epicardium and myocardium. The transmyocardial swab 240 is operable to seal a perforation in the heart wall. In some configurations, as Figure 21 shown, the pericardial anchor 220 and the transmyocardial swab 240 can extend at an angle relative to each other in a pre-deployed configuration. In some configurations, the pericardial anchor 220 and the transmyocardial swab 240 can extend linearly relative to each other.

[0245] The transmyocardial swab 240 is configured to extend from the pericardial anchor 220 and pass through perforations in the epicardium, myocardium, and endocardium, which is also referred to as the heart wall passage 5, as Figure 36 shown. The transmyocardial swab 240 can be filled and sealed via a delivery system that traverses the heart wall into the pericardial space to seal the heart wall passage 5 defined in the epicardium, myocardium, and endocardium. The transmyocardial swab 240 is configured to expand into the perforation of the myocardium to seal the perforation of the myocardium. The portion of the transmyocardial swab 240 positioned to pass through the heart wall passage 5 of the myocardium can extend in a straight configuration, while the material of the transmyocardial swab 240 positioned adjacent to the endocardium can collapse or fold up to seal across the heart wall passage 5 at the endocardium. This advantageously allows the transmyocardial swab 240 to accommodate different myocardial thicknesses by collapsing to the endocardium and / or expanding to a diameter sufficient to prevent leakage through the heart wall passage 5. Suture Lock

[0246] The pericardial anchoring system 200 may also include an anchor socket 260 that may hold a suture lock 270. The pericardial anchoring system 200 may include a suture lock as disclosed in U.S. Patent No. 9,877,833. The pericardial anchoring system 200 may include suture locks and sockets and various embodiments of the suture locks or sockets disclosed therein as disclosed in International Application No. PCT / US2021 / 035423 or U.S. Application No. 16,711,321, the entireties of which are incorporated herein by reference. The pericardial anchoring system 200 may include a socket as disclosed in U.S. Application No. 16 / 710,637, the entireties of which are incorporated herein by reference, and various embodiments of the suture locks or sockets disclosed therein. The suture lock 270 may be used to secure each of the pericardial anchor sutures 280 and the leaflet anchor sutures 310. The suture lock 270 may also be used to tension and adjust the length of each of the pericardial anchor sutures 280 and the leaflet anchor sutures 310. Once the length is optimized to achieve sufficient tension for mitral chordal repair, the suture lock 270 may be locked to secure the length of each of the pericardial anchor sutures 280 and the leaflet anchor sutures 310. Socket

[0247] As used herein, the term "socket" includes the following terms and may be used interchangeably with any of the following terms: cover, container, shield, coupling, restraint, retaining member, etc. According to one embodiment, the anchor socket 260 may have a tubular structure that may receive and at least partially cover the suture lock 270. The anchor socket 260 may include a self-expanding frame that may minimize the profile of the anchor socket 260 when in a pre-deployed configuration on a delivery system. The self-expanding frame may be a stent frame made of nitinol. The self-expanding frame may be tapered to facilitate docking of the suture lock 270 within the anchor socket 260 and more tightly constrain the anchor socket 260 around the sutures 280, 310. In some embodiments, the anchor socket 260 may include a self-expanding frame covered by a membrane. When released from the pre-deployed position, the frame may expand and enlarge the anchor socket 260. The anchor socket 260 may have a distal end that may be tapered and that may be operative to engage within the folds and undulations of the endocardium as opposed to a distal end that may be larger and / or less conducive to engaging the endocardium. This may enhance the stability of the anchor socket 260 due to the dynamic motion of the beating heart. The anchor socket 260 may also include a gold marker band around the periphery of the suture lock 270 that may provide visual guidance. The self-expanding frame may be covered with a fluoropolymer membrane. In some configurations, the inner surface of the stent frame may be covered with a fluoropolymer membrane. The membrane may extend proximally from the membrane of the transmyocardial swab 240. The anchor socket 260 may have a length that exceeds the length of the suture lock 270 to ensure that the suture lock 270 is fully covered by the anchor socket 260. The anchor socket 260 may be a retaining member that restricts the movement of the suture lock relative to the remainder of the pericardial anchoring system 200 and the movement of the sutures relative to the suture lock 270. The anchor socket 260 may also be referred to as a suture lock guide, socket, or sleeve. The anchor socket 260 may reduce wear on each of the pericardial anchor sutures 280 and the leaflet anchor sutures 310, which may ensure the tension in the sutures. The anchor socket 260 may couple the pericardial anchoring system 200 and the suture lock.

[0248] As Figures 21 - 23 shown, the anchor socket 260 and the suture lock 270 may extend proximally or be positioned from the transmyocardial swab 240. This position of the anchor socket 260 advantageously facilitates the folding and collapsing of the transmyocardial swab 240 between the endocardial surface and the anchor socket 260.

[0249] As Figure 22As shown, the transmyocardial swab 240 can further include a catheter access hole 242 located at the proximal end of the transmyocardial swab 240 and adjacent to the anchor socket 260. The catheter access hole 242 in the transmyocardial swab 240 advantageously allows the withdrawal of catheter components, such as but not limited to the guide wire sheath 420 and / or the anchor sheath 440 of the delivery subsystem 400, from the socket lumen 264 of the anchor socket 260, as Figure 22 shown, and extends along the transmyocardial swab 240 and the pericardial anchor 220, as [[ID=!48]]Figure 32 shown.

[0250] Figure 25A is an example of a ventricular anchor system with a separate socket. The anchor socket 260 can be separated from the rest of the pericardial anchor system 200. The anchor socket 260 can be positioned proximally from the transmyocardial swab 240 and connected to the transmyocardial swab 240, but the anchor socket 260 can be separate such that it is configured to translate relative to the transmyocardial swab 240. T - bar Anchor

[0251] As an alternative to the pericardial disc anchor, various types of ventricular or pericardial anchors can present various shapes other than a disc or annular shape. The ventricular or pericardial anchor can be a pull string anchor, where the suture can be tensioned or retracted to convert the anchor from a pre-deployed configuration to a deployed configuration. The pre-deployed configuration can be an elongated configuration. The deployed configuration can adopt various shapes, such as the shapes described above, including disc, annular, curved, compressed, bundled, stuffed, or knotted shapes. Figure 25B is an example of a pericardial anchor system with a T-bar pericardial anchor. Figure 25B The ventricular anchor system in Figure 25B can be similar to the pericardial anchor system 200 described above. However, as an alternative to the wire frame 222 and the skirt 230 of the pericardial anchor 220,

[0252] Figure 26A the ventricular anchor system in Figure 25BThe ventricular anchoring system in [[ ]] can be similar to the pericardial anchoring system 200 described above. However, as an alternative to the wire frame 222 and skirt 230 of the pericardial anchor 220, Figure 25B the ventricular anchoring system in [[ ]] can include a skirtless wire or membrane. The function of the skirtless wire 230 can be similar to that of the skirt 230 of the pericardial anchor 220. The pericardial anchor suture 280 can be integrated or woven through the skirtless wire 230. The pericardial anchor suture 280 can be tensioned to tighten the skirtless wire 230 into a disk, loop, or bundled packing configuration in the deployed configuration, such as Figure 26A shown in [[ ]].

[0253] Figure 26B is an example of a pericardial anchoring system with a T-bar and a frameless pericardial anchor. Figure 25B The ventricular anchoring system in [[ ]] can be similar to the pericardial anchoring system 200 described above. However, as an alternative to the wire frame 222 and skirt 230 of the pericardial anchor 220, Figure 25B the pericardial anchoring system in [[ ]] can include a T-bar proximal leg 228 covered by a membrane called a skirtless wire 230. The T-bar skirt covered by the membrane can extend proximally from the skirtless wire 230. The function of the T-bar 290 can be similar to that of the T-bar proximal leg 228 of the pericardial anchor 220. The T-bar 290 can be positioned against a perforation in the myocardium in the epicardial cavity. The T-bar 290 covered with a membrane or skirt can be integral with or separate from the transmyocardial swab 240. The function of the skirtless wire 230 can be similar to that of the skirt 230 of the pericardial anchor 220. The pericardial anchor suture 280 can be integrated or woven through the skirtless wire 230. The pericardial anchor suture 280 can be tensioned to tighten the skirtless wire 230 into a loop configuration in the deployed configuration, such as Figure 26A shown in [[ ]].

[0254] The function of the skirtless wire 230 can be similar to that of the skirt 230 of the pericardial anchor 220. The pericardial anchor suture 280 can be integrated or woven through the skirtless wire 230. The pericardial anchor suture 280 can be tensioned to tighten the skirtless wire 230 into a disk, loop, curved, or bundled packing configuration in the deployed configuration, such as Figure 26A shown in [[ ]]. Deployed Anchoring System

[0255] Figure 27is an example of a pericardial anchoring system 200 deployed in a ventricle and partially implanted in place. As shown, the pericardial anchor 220 in a loop configuration is positioned in the pericardial space. The pericardial anchor 220 can anchor the pericardial anchoring system 200 and serve as a mechanical interface for anchoring the pericardial anchoring system 200. The pericardial anchor 220 can also be used to seal one end of a myocardial perforation. The transmyocardial swab 240 extends from the pericardial anchor 220, with a portion extending through the heart wall 41 and a portion folded against the endocardial layer of the heart wall 41. The suture lock 270 positioned within the anchor socket 260 can be positioned against the folded portion of the transmyocardial swab 240. The suture lock 270 surrounded by the anchor socket 260 can drive the anchor socket 260 into the endocardial surface, which can also help seal a perforation on the endocardial surface through the folded portion of the transmyocardial swab 240. The pericardial anchor suture 280 can extend through the pericardial anchor 220, through the transmyocardial swab 240 and into the suture lock 270. The pericardial anchor suture 280 can also serve as a tension member for forming the pericardial anchor 220. The pericardial anchor suture 280 can provide a track to connect the suture lock 270. The transmyocardial swab 240 can protect the heart wall 41 from damage caused by the pericardial anchor suture 280. The transmyocardial swab 240 increases the volume of the pericardial anchor suture 280, which by itself may tend to cut or penetrate through the myocardium by applying tension or load. The transmyocardial swab 240 prevents the pericardial anchor suture 280 from migrating within the myocardium. The transmyocardial swab 240 can create a myocardial seal by plugging a channel or perforation through the heart wall 41 and by folding against the opposite end of the perforation on the endocardial surface to seal it. 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 chordae. Leaflet Anchor Implantation

[0256] Figure 28AAn example of a leaflet anchor in an implant valve leaflet and a leaflet anchor suture 310 extending between the leaflet anchor 300 and at least a pericardial anchor system 200 implanted in the ventricular wall is shown. As shown, the pericardial anchor system 200 is implanted in the ventricular wall such that the anchor socket 260 is positioned against the endocardial surface of the heart wall 41. The leaflet anchor 300 can be an anchor in which at least a portion of the anchor is configured to be positioned in or on the leaflet. At least a portion of the pericardial anchor 220 can be embedded in or in contact with the tissue of the leaflet. The leaflet anchor 300 can be of various shapes, such as a swab, a clip, or a hook. The leaflet anchor suture 310 can extend from a suture lock 270 positioned within the anchor socket 260 and extend to the leaflet anchor 300. The leaflet anchor 300 can be an anchor positioned within the mitral valve leaflet 9. The leaflet anchor 300 can be a swab.

[0257] Figure 28B A cross-sectional view of a ventricular wall implanted with a ventricular anchor system is shown. As shown, the pericardial anchor 220 can be positioned within the pericardial space 10. The transmyocardial swab 240 can extend from the pericardial anchor 220 and pass through perforations in the endocardium, myocardium, and epicardium. The transmyocardial swab 240 can also be folded against the endocardial surface of the heart wall 41. The anchor socket 260 can be positioned against the endocardium of the heart wall 41.

[0258] Figure 28C A view of the pericardial anchor 220 implanted within the pericardial space is shown. Sheath Delivery Sub - system

[0259] Figure 29 An example of a delivery system or delivery subsystem 400 in a first configuration is shown. Figure 30 An example of a Figure 29 delivery subsystem 400 in a second configuration is shown. Figure 31 An example of a Figure 29 and 30 guide wire sheath of the delivery subsystem 400 is shown.

[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 guide wire sheath 420. The delivery subsystem can also include a guide wire 410 configured to be delivered through the guide wire sheath 420. The sheaths 420, 440, 460 can be configured to cooperate with each other or nested within each other. The support sheath 460 can be an outer sheath that receives the anchor sheath 440. The anchor sheath 440 can be an intermediate sheath received by the support sheath 460 and that receives the guide wire sheath 420. The guide wire sheath 420 can be received by the anchor sheath 440 and receive the guide wire 410.Figure 29 shows the guide wire sheath 420 being pulled distally from the anchor sheath 440 further than Figure 30 shown. The guide wire 410 may be positioned within the inner periphery of the guide wire sheath 420. This allows for the delivery of the guide wire 410 through the guide wire sheath 420. The pericardial anchoring system 200 may be positioned between the outer periphery of the guide wire sheath 420 and the inner periphery of the anchor sheath 440. This allows for the delivery of the pericardial anchoring system 200 by retracting the anchor sheath 440.

[0261] Figure 32 is an example of a guide wire sheath 420 with a pericardial anchoring system 200. The anchor sheath 440 has been retracted. As Figure 32 shown, the pericardial anchoring system 200 may be positioned on the outer surface of the guide wire sheath 420. The guide wire sheath 420 may include a plurality of sleeves 424 that are on the outer surface of the guide wire sheath 420 and between portions of the pericardial anchoring system 200 to constrain the portions of the pericardial anchoring system 200. For example, the sleeves 424 may be positioned on either side of the socket 260 of the pericardial anchoring system 200. The sleeves 424 may assist in advancing or positioning the various parts of the ventricular anchoring system. For example, the sleeve 424 may be positioned proximal to the pericardial anchor 220 and may enable the pericardial anchor 220 to advance as the guide wire sheath 420 advances. For example, the sleeve 424 may be positioned proximal to the pericardial anchor 220 and can effect the positioning of the proximal leg 228 of the T-bar of the pericardial anchor 220 during implantation. The sleeve 424 may be made of plastic. The guide wire sheath 420 may additionally include fluoroscopic markers. The anchor sheath 440 may be positioned over the pericardial anchoring system 200 to constrain the pericardial anchoring system 200 until ready for deployment. The distal end 442 of the anchor sheath 440 may be used to engage the T-bar after deployment to provide abutment or leverage against the wire frame 222 during tightening of the pericardial anchor sutures 280.

[0262] The support sheath 460 can provide control to direct the delivery subsystem 400 to a target location, such as to the left ventricle or the ventricular wall of the left ventricle. The support sheath 460 can provide support while the pericardial anchoring system advances through the ventricular wall, such as guiding the guide wire 410 or the anchor sheath 440 forward. The support sheath 460 can have at least a compliant distal portion. The distal portion of the anchor sheath 440 is operable to advance through the heart wall 41, including the endocardium, myocardium, and epicardium of the heart wall 41. The anchor sheath 440 can have at least one proximal portion that is more rigid relative to the compliant distal portion, which can provide more control during delivery. The anchor sheath 440 can include a radiopaque marker at the distal end or distal tip of the anchor sheath 440.

[0263] The guide wire sheath 420 can be a thin-walled catheter. The guide wire sheath 420 can include a dilator tip 422 at the distal end of the guide wire sheath 420. The dilator tip 422 can be smooth and tapered to minimize trauma when passing through the heart wall 41. The proximal end of the dilator tip 422 can be tapered to allow the dilator tip 422 to be withdrawn smoothly and to minimize trauma during withdrawal of the dilator tip 422 through the heart wall 41.

[0264] Figures 33 - is a series of illustrations of a method of providing the pericardial anchoring system 200 according to one embodiment.

[0265] ​ is a cross-sectional view of a heart with a delivery catheter 500 according to an embodiment of a method of providing the pericardial anchoring system 200. The delivery catheter 500 can be positioned in the left atrium. The delivery catheter 500 can be delivered using a trans-femoral, trans-septal approach.

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

[0267] ​Cross-sectional view of the heart wall 41 with a guide wire 410 having a delivery subsystem 400, according to an embodiment of a method for providing a pericardial anchoring system 200. The guide wire 410 of the delivery subsystem 400 can be advanced distally from the distal end of the support sheath 460. The guide wire 410 can pierce the heart wall 41 to advance through the heart wall 41, including the endocardium, myocardium, and epicardium, and be guided into the pericardial space 10. The guide wire 410 is positioned in the pericardial space 10 such that an anchor can subsequently be delivered on the guide wire 410 and into the pericardial space 10. The selection of the guide wire stiffness can be optimized at the distal end and along the entire length such that, but not limited to, the distal end is stiff enough such that it can penetrate the heart wall 41 and enter the pericardial space 10 and yet soft enough to deflect into the pericardial space 10 and not pierce the pericardium (the parietal layers of the serous pericardium and the fibrous pericardium). The guide wire 410 is operable to rotate within the pericardial space 10 and travel within the pericardial space 10. The advancement of the distal end of the guide wire within the pericardial space 10 and adjacent to the heart wall 41 can provide evidence to the clinician of the distal end of the guide wire 410 within the pericardial space 10. Since the guide wire 410 traverses the pericardial space 10 and subsequently the guide wire 410 is free to move within the pericardial space 10, the deflection of the guide wire 410 into the pericardial space 10 can advantageously provide tactile feedback.

[0268] ​ Cross-sectional view of the heart wall 41 with an anchor sheath 440, according to an embodiment of a method for providing a pericardial anchoring system 200. The anchor sheath 440 and the guide wire sheath 420 having a dilator tip 422 can be advanced distally together from the support sheath 460 and advanced over the guide wire 410, through the heart wall 41, including the endocardium, myocardium, and epicardium, and into the pericardial space 10.

[0269] ​ Cross-sectional view of the heart with an anchor sheath 440, according to an embodiment of a method for providing a pericardial anchoring system 200. The anchor sheath 440 and the guide wire sheath 420 having a dilator tip 422 can be advanced far into the pericardial space 10. The anchor sheath 440 and the guide wire sheath 420 can be advanced a predetermined distance to allow the pericardial anchor in the pre-deployed configuration to be ejected (from the sheath). For example, as ​As shown, the anchor sheath 440 and the guide wire sheath 420 can be advanced into the pericardial space 10 by at least 10 cm and, in some embodiments, between at least 15 cm and 16 cm into the pericardial space 10. For example, the anchor sheath 440 and the guide wire sheath 420 can be tangentially deployed within the pericardial space and alongside the heart wall 41. In some examples, the anchor sheath 440 and the guide wire sheath 420 can extend until they are adjacent to the right atrium. The anchor sheath 440 and the guide wire sheath 420 can be advanced in a medial / lateral direction or an inferior / superior direction or a combination thereof. This advantageously does not require extensive or additional dilation or extension of the pericardial space itself because the anchor sheath 440 and the guide wire sheath 420 can travel tangentially within the pericardial space 10. The anchor sheath 440 and the guide wire sheath 420 extend for a sufficient length to allow the pericardial anchor 220 in an elongated configuration to be ejected (from the sheath).

[0270] ​ FIG. 4 is a cross-sectional view of the heart wall 41 with the anchor sheath 440 according to an embodiment of a method of providing a pericardial anchoring system 200, the anchor sheath being partially retracted to deliver the pericardial anchor 220 of the pericardial anchoring system 200. With the guide wire sheath 420 maintained in place, the support sheath 460 and the anchor sheath 440 can be retracted together, exposing the pericardial anchoring system 200, which is positioned between the anchor sheath 440 and the guide wire sheath 420. In some examples, the anchor sheath 440 can be retracted until the marker band on the anchor sheath 440 reaches the marker band on the guide wire sheath 420. This will eject the pericardial anchoring system 200. Once it is no longer constrained by the anchor sheath 440, the distal anchor 225 of the pericardial anchor 220 can initially be ejected (from the sheath) and begin to transform (such as by bending or coiling) due to the biasing or shape memory properties of the biasing element. When the pericardial anchor 220 is fully exposed and ejected, the proximal leg 228 of the pericardial anchor 220 can abut against the end of the anchor sheath 440 and the heart wall 41 as the anchor sheath 440 is retracted.

[0271] ​A cross-sectional view of the heart wall 41 with the anchor sheath 440 partially retracted to deliver the pericardial anchoring system 200, according to an embodiment of a method of providing the pericardial anchoring system 200. The position of the anchor sheath 440 can thus be maintained, and the guide wire sheath 420 can be retracted to form a T-bar between the proximal leg 228 of the pericardial anchor 220 and the end of the anchor sheath 440. Then all the sheaths, namely the support sheath 460, the anchor sheath 440, and the guide wire sheath 420, can be retracted together until the proximal leg 228 is positioned against the perforation in the epicardium. The pericardial anchor 220 can be positioned between the epicardium and the guide wire sheath 420. This can prevent the pericardial anchor 220 from retracting into the perforation in the epicardium and can maintain the position of the pericardial anchor 220 in the pericardial space. Deployment / Delivery of Pericardial Anchor

[0272] ​ A cross-sectional view of the heart wall 41 with the anchor sheath 440 partially retracted to deliver the pericardial anchoring system 200, according to an embodiment of a method of providing the pericardial anchoring system 200. The position of the guide wire sheath 420 can thus be maintained, and the anchor sheath 440 and the support sheath 460 can be retracted together to deploy the transmyocardial swab 240 and the anchor socket 260. The transmyocardial swab 240 can be placed in the perforation through the myocardium as the anchor sheath 440 and the support sheath 460. Once the perforation in the myocardium is filled, the remaining or excess length of the transmyocardial swab 240 can extend proximally from the endocardium, as ​ shown. The anchor socket 260 can extend proximally from the transmyocardial swab 240.

[0273] ​ A cross-sectional view of the heart wall according to an embodiment of a method of providing the pericardial anchoring system 200, in which the guide wire sheath 420 is retracted to deliver the pericardial anchoring system 200. The guide wire sheath 420 and the guide wire 410 can be retracted to deploy the pericardial anchoring system 200. Then the guide wire sheath 420, the anchor sheath 440, and the support sheath 460 can all be withdrawn to fully expose the pericardial anchoring system 200. Once the pericardial anchoring system 200 is fully deployed, the pericardial anchor suture 280 can be tensioned to fully coil or curl the pericardial anchor 220. The pericardial anchor suture 280 can also be tensioned to tighten the skirt 230 around the wire frame 222 in a loop configuration, as ​ shown. This converts the pericardial anchor 220 from a straight configuration in the pre-deployed state to a coiled configuration in the deployed state.

[0274] The pericardial anchor 220 can, during delivery, such as by ​The shown anchor sheath 440 is constrained into a pre-deployment configuration. The pericardial anchor 220 can be delivered and positioned in the pericardial space 10 via a delivery subsystem 400, such as ​ as shown. When the pericardial anchor 220 is positioned in the pericardial space 10 and released from the anchor sheath 440, the shape memory of the wire frame 222 can begin to transform the pericardial anchor 220 from an elongated configuration in the pre-deployment state to at least a partially coiled configuration. The distal end of the pericardial anchor 220 having the distal eyelet 224 in a straight configuration is initially released from the anchor sheath 440. As ​ shown, the anchor distal end 225 is the free end of the pericardial anchor 220, which can begin to transform (such as curl or coil) when it exits the anchor sheath 440 and is no longer constrained by the anchor sheath 440. However, the limited space of the pericardial space 10 may constrain the pericardial anchor 220 and prevent it from achieving a fully bent or coiled configuration in the deployed configuration. Then, when the anchor sheath 440 is further retracted from the guide wire sheath 420, the remainder of the pericardial anchor 220 is released from the anchor sheath 440 via the proximal leg 228. The remainder of the pericardial anchor system 200 can be released from the anchor sheath 440, including the transmyocardial swab 240 and the anchor socket 260. Then, the pericardial anchor suture 280 of the pericardial anchor system 200 can be tensioned to fully coil the pericardial anchor 220 and tighten the skirt 230 of the pericardial anchor 220, which can fully transform the pericardial anchor 220 into a fully coiled configuration in the deployed state. The pericardial anchor 220 can be positioned against the epicardial perforation.

[0275] ​ is a cross-sectional view of a heart wall 41 implanted with the pericardial anchor system 200 according to an embodiment of a method of providing the pericardial anchor system 200. As shown, the fully coiled pericardial anchor 220 can be positioned in the pericardial space 10 and against the epicardial perforation to seal the epicardial perforation. At least a portion of the transmyocardial swab 240 can fill the perforation of the endocardium, myocardium, and endocardium. The remainder of the transmyocardial swab 240 can extend proximally from the epicardial perforation. The anchor socket 260 can extend proximally from the transmyocardial swab 240. As will be further discussed below, the remainder of the transmyocardial swab 240 can collapse or fold to be positioned against the perforation of the endocardium to seal the perforation of the endocardium. ​

[0276] [[ID=;13]]According to one embodiment, the pericardial anchor system 200 can be used to control the movement of the mitral valve leaflets by coupling the pericardial anchor suture 280 to one or more leaflet anchor sutures 310, also known as tethers, which are themselves coupled to the mitral valve leaflets 9. As ​As shown, after the pericardial anchor 220 is delivered to the target location, the pericardial anchor suture 280 can be coupled to the mitral valve leaflet 9 by using the leaflet anchor system 510. The anchor system 510 includes a leaflet anchor 300 and a leaflet anchor suture 310, and the leaflet anchor suture is operable to pass through the mitral valve leaflet 9 and couple to the mitral valve leaflet. In some embodiments, the leaflet anchor can be delivered to the mitral valve prior to delivering the pericardial anchor. In some embodiments, the leaflet anchor suture 310 can be coupled to the mitral valve leaflet 9 before the leaflet anchor suture 310 is coupled to the pericardial anchor suture 280. In some embodiments, the leaflet anchor suture 310 can pass through the mitral valve leaflet 9.

[0277] ​ is a series of illustrations of an embodiment of the leaflet anchor system 510 and shows an embodiment of a method of providing leaflet tethering using the pericardial anchor system 200 in combination with the leaflet anchor system 510. In some examples, this method of providing leaflet tethering can be provided multiple times such that multiple leaflet tethers can be provided. In some examples, according to one embodiment, the leaflet anchor system 510 can be used to pass the leaflet anchor suture 310 through the mitral valve leaflet 9 multiple times.

[0278] ​ is a cross-sectional view of the heart 4 of a delivery subsystem 520 that can operate with the leaflet anchor system 510 according to an embodiment of a method of providing leaflet tethering using the leaflet anchor system 200. The delivery subsystem 520 for the leaflet anchor system 510 can be delivered via a delivery catheter 500. The delivery subsystem 520 can be positioned adjacent a first side of the leaflet 9, such as but not limited to the atrial side of the leaflet 9.

[0279] ​ is a cross-sectional view of the heart 4 according to one embodiment, showing the needle 522 of the leaflet anchor system 510. The delivery subsystem 520 can deliver the needle 522, which can be positioned adjacent a first side of the leaflet 9. The needle 522 can extend to pierce the leaflet 9 to extend from a first side of the leaflet 9 to a second side of the leaflet 9, such as but not limited to from the atrial side to the ventricular side of the leaflet 9. ​

[0280] ​ is a cross-sectional view of the heart 4 according to one embodiment, showing the leaflet anchor 524. The leaflet anchor 524 can be delivered by the needle 522 such that the leaflet anchor 524 extends from the distal end of the needle 522. In one embodiment, the leaflet anchor system 312 includes the leaflet anchor suture 310 and the leaflet anchor 524, such as but not limited to the leaflet anchor 300, as ​ and 46 shown. According to one embodiment, as ​As shown, the leaflet anchor 524 is the leaflet anchor 300 coupled to the leaflet anchor suture 310, such as but not limited to, integrally formed with or woven through the leaflet anchor 300 and extending from the leaflet anchor 300 to the leaflet anchoring system 312. Embodiments of the leaflet anchor 524 also include but are not limited to knots, sutures, staples, adhesives, and suture clips.

[0281] ​ is a cross-sectional view of the heart 4 having a leaflet anchor 524 according to one embodiment. The leaflet anchor suture 310 can be tensioned to collapse or fold the leaflet anchor 524, in this embodiment the leaflet anchor 300, against the second side of the leaflet 9. The leaflet anchor 300 is operable to tighten into a compressed configuration when tension is applied to the leaflet anchor suture 310 and is operable to prevent the leaflet anchor 300 from being pulled through the perforation in the leaflet 9 through which the leaflet anchor extends. In some embodiments, the leaflet anchoring system 312 can include more than one leaflet anchor suture 310. In some embodiments, each leaflet anchor suture 310 can be tensioned individually. The tensioning of each leaflet anchor suture 310 can be based on the position of the leaflet anchor relative to the suture lock, as further described below. The individualized tensioning of each leaflet anchor suture 310 can help ensure accurate and individualized motion control of the various parts of the mitral valve.

[0282] ​ is a cross-sectional view of the heart 4 in which the delivery subsystem 520 for the leaflet anchoring system 312 has been withdrawn. The delivery subsystem 520 can be withdrawn through the delivery catheter 500.

[0283] Once the leaflet anchoring system 312 is deployed to the target location in the leaflet 9, a suture lock 270 can be provided to lock the leaflet anchor suture 310 to the pericardial anchoring system 200 and to lock the leaflet anchor suture 310 to one or more leaflet anchors 524 disposed in the leaflet 9. ​ is a series of illustrations of a method of providing a suture lock according to one embodiment. The suture lock 270 is operable to couple the corresponding sutures. ​

[0284] ​ is a cross-sectional view of the heart 4 having a suture lock delivery subsystem 530 operable to deploy the suture lock 270. The suture lock delivery subsystem 530 for the suture lock 270 can be delivered through the distal end 502 of the delivery catheter 500, which in this embodiment is located in the right atrium, but is not limited thereto. The suture lock 270 can be delivered to engage the tail 313 of the pericardial anchor suture from the pericardial anchor suture 280, as ​as shown, and joining one or more leaflet anchor suture tails 319 from one or more leaflet anchor sutures 310, as ​ shown. The pericardial anchor suture 280 is tensioned to provide a predetermined tension between the pericardial anchor system 200 and the leaflet anchor 524. The suture lock 270 can then be locked to couple the pericardial anchor suture 280 and the suture lock 270 to maintain the desired tension.

[0285] ​ is a cross-sectional view of the heart 4 with the suture lock 270 positioned in the anchor socket 260 of the pericardial anchor system 200. The suture lock 270 can thus be positioned within the anchor socket 260 using the pericardial anchor suture 280, with the pericardial anchor suture serving as a track to guide the suture lock 270 to the anchor socket 260. According to one embodiment, the ventricular anchor suture and the leaflet anchor suture are fed through the suture lock, and the suture lock is tracked along the ventricular anchor suture used as a track to the ventricular anchor. The transmural anchor is bellows-shaped during the process of bringing the lock to the heart wall. After a predetermined tension has been applied to the leaflet anchor to correct the function of the valve leaflets, the sutures are locked together. According to another embodiment of the method, the anchor sutures are tensioned, the transmural anchor swab is tightened, the leaflet anchor is tensioned, and then the sutures are coupled together. According to another embodiment, the transmural swab is tightened, the pericardial anchor system 200 is deployed, the suture lock 270 is positioned, the leaflet anchor is tensioned, and the sutures are coupled together. ​ is a cross-sectional view of the heart wall 41 with the suture lock 270 positioned in the anchor socket 260 of the pericardial anchor system 200.

[0286] ​ is a cross-sectional view of the heart 4 with the anchor socket 260 of the pericardial anchor system 200 positioned against the heart wall 41. According to one embodiment, the pericardial anchor system 200 does not include an anchor socket 260 in which the suture lock 270 is operable to affect tissue ingrowth. ​ is a cross-sectional view of the heart wall 41 with the pericardial anchor system 200. The suture lock 270 positioned in the anchor socket 260 can be further lowered to be positioned against the heart wall 41, which in turn can fold or collapse the excess length of the transmural swab 240 against the heart wall 41. The suture lock 270 positioned within the anchor socket 260 can be positioned against the folded portion of the transmural swab 240. The suture lock 270 surrounded by the anchor socket 260 can drive the anchor socket 260 into the endocardial surface, which can also help seal the perforation on the endocardial surface through the folded portion of the transmural swab 240. As ​As shown, a portion of the transmyocardial swab 240 collapses and compresses between the suture lock 270 positioned 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] Once the suture lock 270 has been delivered to the target location within the anchor socket 260, a suture cutter 542 can be provided to cut the suture tails of one or more leaflet anchor sutures 310 and the suture tails of the pericardial anchor sutures 280. ​ is a series of illustrations of a method for providing a suture cutter according to one embodiment. ​ is a cross-sectional view of a heart with a 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 slide along the sutures 280, 310 toward the suture lock 270. After the sutures 280, 310 have been tensioned by the suture lock 270, the suture cutter 542 can cut the excess suture tails of the sutures 280, 310. ​ is a cross-sectional view of a heart with the suture cutter 542 withdrawn. The suture cutter 542 can then be withdrawn from the heart through the delivery catheter 500. ​ is a cross-sectional view of a heart with the delivery catheter withdrawn. The delivery catheter 500 can then be withdrawn from the heart.

[0288] ​ is a cross-sectional view of a heart provided with a plurality of leaflet anchors 524. ​ is a cross-sectional view of a heart with a plurality of leaflet anchor sutures 310. As previously described, a plurality of leaflet anchor sutures 524 can be provided and implanted into the leaflets 9. Each of the plurality of leaflet anchor sutures 524 can have a leaflet anchor suture 310 connected to the pericardial anchor system 200 as described herein.

[0289] According to other embodiments, the present disclosure relates to devices, systems, and methods for placing hardware, devices, or therapeutics from the ventricular side of the heart into the pericardial space. Although the embodiments herein are discussed with respect to the intravascular position and ventricle of the patient, these embodiments are applicable to placement into the pericardial space in a variety of ways, including improvements to current methods performed percutaneously from outside the chest or abdomen. ​

[0290] When the tool is used to place a device or therapeutic agent into the pericardial space, the present disclosure may be performed using echocardiography and / or fluoroscopy, and the deployment and use of the tool may be permanent or reversible.

[0291] In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of some embodiments. However, one of ordinary skill in the art will understand 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 using an endovascular approach to place hardware, devices, or therapeutic agents from the ventricles of the heart into the pericardial space. Such placement may be necessary when treating 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 deploy into the myocardium and extend from the ventricular side of the heart into the pericardial space. These embodiments enable traversing the myocardium while minimizing the risk or extent of myocardial injury, bleeding, or placement in an adverse location.

[0293] ​ and 54B are a side view and a cross-sectional view, respectively, of a tool 150 according to one embodiment. Embodiments of the tool 150 may be used with a small-caliber (approximately 0.018-inch diameter) catheter-based delivery system referred to as a delivery catheter system 50, but may be larger or smaller and have the same components specific to the intended use. According to one embodiment, the tool 150 includes a body 170 and a head 160, wherein the body 170 is operable to deploy within the myocardium and the head 160 is operable to extend from the myocardium into the pericardial space 10. In one embodiment, the head 160 includes movable elements. According to one embodiment, these movable elements are operable to expand the pericardial space 10 during and / or after deployment of the tool 150. According to one embodiment, these movable elements are operable to anchor the tool 150 within the pericardial space 10 after placement. According to one embodiment, the body 170 defines a lumen 172 and the head 160 defines one or more apertures 124 in fluid communication with the lumen 172, wherein the lumen 172 and the apertures 174 are operable to provide fluid communication between the ventricle 22 and the pericardial space 10. The combination of the lumen 172 and the one or more apertures 124 is referred to as an access channel 176. According to one embodiment, the access channel 176 is operable to provide fluid communication between the ventricle 22 and the pericardial space 10, is operable to facilitate confirmation of the placement of the tool 150 within the pericardial space 10, and provides a passage for wires, catheters, or devices to enter the pericardial space 10 from the ventricular side of the heart 2.

[0294] According to one embodiment, the access channel 176 may include an occlusion element 175 that is operable to occlude or stop fluid communication through the access channel 176. According to one embodiment, the aperture 174 includes an elastic material that is operable to open under the abutting force of an object passing through the inner lumen 172 or the action of fluid or gas pressure, and is operable to close fluid communication with the inner lumen 172 when the object or fluid or gas pressure is not present at the aperture 174. In another embodiment, the aperture 174 further includes a flap that is operable to open under the abutting force of an object or the action of fluid or gas pressure, and is operable to close fluid communication with the inner lumen 172 when the object or fluid or gas pressure is not present at the aperture 174.

[0295] According to an embodiment, the movable member 161 may be the anchor expander member 162 and / or the anchor attachment member 164.

[0296] The anchor expander member 162 is operable to provide a graded cruciform profile in a pre-deployment configuration and to support the parietal pericardium when the anchor expander member 162 expands or moves to a deployed configuration.

[0297] The anchor attachment member 164 is operable to provide a graded cruciform profile in a pre-deployment configuration and to support against the visceral pericardium 19 when the anchor attachment member 164 expands or moves to a deployed configuration in the pericardial space 10. The movable member 161 is operable to function as both the anchor expander member 162 and the anchor attachment member 164, i.e., they are one of the same members.

[0298] The body 170 is operable to occupy the transsection 28 after passing through the myocardium to maintain hemostasis. As will be discussed below, the heart wall 4 is pierced from the ventricular side to the pericardial space 10 side by the needle 56 and / or the tool 150 to deploy the tool 150 therebetween. The heart wall channel pierced or formed in the heart wall 4 is referred to herein as the transsection 28.

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

[0300] ​FIG. 0 is a cross-sectional view of tool 150 according to one embodiment, showing actuation mechanism 58 operable to extend and / or retract movable member 161. According to one embodiment, actuation mechanism 58 is a cable or lever member operable to lift movable member 161 to move to a deployed configuration once head 160 has been placed in a desired position. According to one embodiment, these movable members 161 are operable to serve as anchors after deployment.

[0301] Delivery catheter system 50 is operable to deliver the tool to a desired location. According to one embodiment, delivery catheter system 50 includes steerable catheters 51, 53 that can receive one or more delivery catheters 55, which are operable to place and deploy tool 150, where body 170 is located in heart wall 4 and head 160 extends therefrom and is located in pericardial space 10. 54C is a cross-sectional view of left ventricle 22 and mitral valve 8 according to one embodiment, showing delivery catheter system 50 for placing tool 150. Delivery catheter system 50 includes steerable catheters 51, 53 that have been placed by a transvenous, transseptal method to pass through the mitral valve into left ventricle 22 and then into the pericardium. Each of these steerable catheters 51, 53 contains cables for steering in multiple directions to achieve a perpendicular trajectory to the myocardium or a trajectory preferred for the treatment to be implanted, as ​ shown, this figure is a cross-sectional view of left ventricle 22 showing the distal end 52 of the delivery catheter. Delivery catheter system 50 can be in a single, tandem, or nested arrangement. Although the figures show a transvenous, transseptal method, delivery catheter system 50 and tool 150 can be used similarly with a transatrial or transaortic method. Similarly, delivery catheter system 50 can be inserted into pericardial space 10 from either atrium and either ventricle 22.

[0302] According to various embodiments, delivery catheter system 50 includes guide wire 54 and needle 56, either alone or in combination, operable to provide support for traversing the myocardium and piercing visceral pericardium 19. Needle 56 can be coupled to or integral with guide wire 54, which can be advanced into pericardial space 10 after piercing visceral pericardium 19 to facilitate subsequent catheter replacement, as ​ shown.

[0303] ​ FIG. 14 shows the sequence of using delivery catheter system 50 to deliver tool 150 according to one embodiment. ​ FIG. 16 is a cross-sectional view of heart 2 according to one embodiment, showing delivery catheter system 50 positioned adjacent to endocardium 11. As ​As shown, the steerable guide catheter 55 is steered to the target site and opposed to the surface of the endocardium 11. A trajectory is established by steering different steerable catheters 51, 53, 55, which is confirmed by echocardiography, fluoroscopy, or other similar imaging methods.

[0304] Then the tool 150 is advanced through the myocardium 13. ​ is a cross-sectional view of the heart 2 according to one embodiment, showing the tool 150 being advanced across the endocardium 11 and myocardium 13 with the assistance of the needle 56 during deployment to be placed in the myocardium 13 and the pericardial space 10. This advancement can be assisted by the needle 56 and the use of electrical energy, cryoablation, radiofrequency, or mechanical force. In at least one embodiment, the tool 150 utilizes a mechanical method, where the needle 56 is used to pierce the myocardium with a stylet to reduce tissue tunneling. In at least one other embodiment, the tool 150 uses radiofrequency energy or cautery. In at least one other embodiment, the tool 150 has a beveled or non-beveled sharp tip that aids in crossing with or without the support needle 56 or guide wire 54. In at least one other embodiment, the rotation of the tool 150 aids in crossing the myocardium. These embodiments enable crossing the myocardium while minimizing the risk or extent of myocardial damage, bleeding, or misplacement. The tool 150 is advanced to the visceral pericardium 19 and slowly crosses the visceral pericardium 19.

[0305] ​ is a cross-sectional view of the heart 2 according to one embodiment, showing the tool 150 being advanced across the epicardium 14 during deployment to be placed in the myocardium 13 and the pericardial space 10. Once through the visceral pericardium 19, the eyelet 174 is positioned in the pericardial space 10 without crossing the parietal pericardium layer. This positioning is achieved by the bluntness of the end of the tool 150, the relative rigidity compliance of the parietal pericardium layer, and the potential space between the visceral pericardium 19 and the parietal layer. In at least one embodiment, signals from the eyelet 174, such as but not limited to hydrostatic pressure or electrical impedance, are monitored to determine when the visceral pericardium 19 has been crossed and the head 160 of the tool 150 is in the pericardial space 10. ​ is a cross-sectional view of the heart 2 according to one embodiment, showing the tool 150 expanding the pericardial space 10 during deployment. According to one embodiment, confirmation of the position can also be obtained by injecting a contrast agent or imaging substance, as ​ shown. When the tool 150 is advanced, injection of these substances can assist in expanding the pericardial space 10.

[0306] In some embodiments, the aperture 174 facilitates confirmation of placement within the pericardial space 10 and entry of wires, catheters, or devices into the pericardial space 10. The aperture 174 can be used to transducer hydraulic or body cavity wall pressures and to deliver contrast or chromogenic agents. The aperture 174 can also be used to inject materials into the pericardial space 10 and expand the pericardial space 10 (e.g., gas, fluid, or mechanical dilators) to facilitate subsequent device placement. In at least one embodiment, the aperture 174 is located at the distal end of the tool 150 and faces the pericardial space 10 in an orientation orthogonal, perpendicular, or angled to the pericardial plane. In at least one embodiment, the aperture 174 can be positioned more proximally to or along the length of the head 160 of the tool 150. In other embodiments, the aperture 174 can be oval, circular, square, rectangular, or another geometric shape and size. In other embodiments, the number of apertures 174 can be plural, with some or all in fluid communication with one or more lumens 172 in the body 170.

[0307] ​ is a cross-sectional view of the heart 2 according to one embodiment, showing the movable elements of the tool 150 that expand the pericardial space 10 during deployment. As ​ shown, according to embodiments, once the tool 150 has advanced into the pericardial space 10, the anchor dilator members 162 are released via retraction or disengagement of a retaining cable or similar element. These anchor dilator members 162 are operable to create greater bluntness and force to push against the parietal pericardium, thereby expanding the pericardial space 10. This expansion enables larger elements to be advanced into the pericardial space 10 as needed. <�

[0308] In some embodiments, the tool 150 includes movable elements that assist in expanding the pericardial space 10 as the tool 150 advances. In at least one embodiment, the head 160 defines these movable elements as being at or near the distal end of the tool 150 and being controlled by a cable or push / pull rod. In at least one embodiment, the movable elements facilitate expansion and anchoring of the pericardial space 10.

[0309] ​ is a cross-sectional view of the heart 2 according to one embodiment, showing the movable elements of the tool 150 that engage the epicardium 14 and / or pericardium 18 to anchor the tool 150 within the pericardial space 10. As ​ shown, the anchor dilator members 162 can expand or retract as the tool 150 advances to create more space within the pericardial space 10. Once the head 160 of the tool 150 is positioned within the pericardial space 10, the anchor attachment members 164 expand or deploy as ​ shown. ​A cross-sectional view of the heart 2 according to one embodiment, showing a movable element of the tool 150 engaging the epicardium 14 and / or the pericardium 18 to anchor the tool 150 in the pericardial space 10. The head 160 of the tool 150, which includes the movable element, can be retracted, rotated, or repositioned to a position on the surface of the visceral pericardium 19 (i.e., the epicardium). ​ A top view of the head 160, showing a movable member 161 according to one embodiment, in which the expanded anchoring member 164 and the anchor expander member 162 are placed in the deployed configuration in this embodiment.

[0310] Once a satisfactory position is obtained, the pericardial anchor tool 150 is separated from the delivery catheter system 50. The tool 150 is held by the engagement of a holding element 180 that cooperatively engages the head 160 of the tool 150, leaving the tool 150 within the myocardium and extending into the pericardial space 10 for use. According to one embodiment, the eyelet 174 can be closed to prevent fluid communication between the ventricle 22 and the pericardial space 10 by the occluding element 175.

[0311] ​ Shows different configurations of the anchor expander member 162 and the anchor attachment member 164. They can be symmetric, asymmetric, of different lengths, concave or convex, with different pads and sizes, and offset or perpendicular.

[0312] In some embodiments, similar methods of using the tool 150 to access the pericardial space 10 described herein can also be used to place a device, anchor, or therapeutic agent on the surface of the parietal pericardium.

[0313] The inventive features of the present disclosure have been generally described above and with reference to specific embodiments. Those skilled in the art will appreciate that various modifications and changes can be made to the embodiments without departing from the scope of the present disclosure. Accordingly, the embodiments are intended to cover modifications and variations of the present disclosure, provided they fall within the scope of the appended claims and their equivalents.

Claims

1. An anchoring system, comprising: An anchor; And A tether, the tether being coupled to the anchor, the anchor being operable to have a small profile in a first position and a larger profile in a second position, the anchor being operable to advance from a ventricle of the heart through a narrow entry passage in the heart wall into the pericardial space, and expand in the pericardial space to a size larger than the narrow entry passage in the second position.

2. The anchoring system according to claim 1, wherein The anchor comprises: A wire having a first end of the wire and a second end of the wire, the wire having a shape memory characteristic with a shape set to a loop configuration, wherein the first end of the wire is opposite to the second end of the wire; A skirt, the skirt being coupled to the wire along an edge defining a length; and A plurality of holes, the plurality of holes being along an edge of the skirt opposite to the wire, Wherein the tether is alternately woven through the plurality of holes, the tether defining a first end of the tether and a second end of the tether, and Wherein the first end of the tether and the second end of the tether are operable to be tensioned to tighten the skirt into a disk-like shape when the wire is in the loop configuration in the deployed 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 the pre-deployed configuration.

3. The anchoring system according to claim 2, wherein, The first end of the wire and the second end of the wire are operable to be fixedly coupled together when in the loop configuration.

4. The anchoring system according to claim 2, characterized in that, The first end of the wire and the second end of the wire are operable to engage to prevent the overlap of the first end of the wire and the second end of the wire from exceeding the complete loop of the wire when in the annular configuration.

5. The anchoring system according to claim 2, characterized in that, The skirt has tissue ingrowth characteristics on one side and tissue anti-adhesion characteristics on the other side.

6. The anchoring system according to claim 2, characterized in that, Further comprising: A tether lock slidably coupled to the tether, the tether lock being operable to slide along the tether and lock in place to capture tissue between the tether lock and the anchor.

7. The anchoring system according to claim 6, characterized in that, Further comprising: A tether lock nesting element slidably coupled to the tether, the tether lock nesting element being operable to slide along the tether and receive the tether therein.

8. An anchoring method, the method comprising: Providing the anchoring system according to any one of claims 2-7: Advancing a guide wire into the femoral vein; Advancing the guide wire through the femoral vein and into the right atrium; Advancing the guide wire through the septum and into the left atrium; Advancing the guide wire through the mitral valve until adjacent to the heart wall of the left ventricle; Advancing a needle catheter over the guide wire and through the endocardium into the myocardium of the heart wall; Advancing the guide wire through the needle catheter, through the myocardium and through the epicardium into the pericardial space; Withdrawing the needle catheter from the guide wire; Advancing a catheter over the guide wire and into the pericardial space; Inflating the pericardium and separating it from the heart wall to expand the pericardial space; Advancing the anchoring system over the guide wire or through the catheter, and placing the anchor of the anchoring system into the pericardial space; Deploy the anchor of the anchoring system within the pericardial space and position the anchor opposite the epicardium, wherein the anchor is in a straight configuration in a pre-deployed configuration via the tension on the first end and the second end of the tether, and wherein the anchor is in a loop configuration in a deployed configuration via the tension on the first end and the second end of the tether; and Remove the guide wire and / or the catheter from the patient, leaving the tether attached to the anchor within the heart chamber.

9. An anchoring method, the method comprising: Provide the anchoring system according to any one of claims 2-7: [[ID= ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Advance the guide wire through the anchoring catheter such that the distal end of the guide wire advances through the endocardium and into the myocardium, through the epicardium and into the pericardial space; Advance the distal end of the anchoring member catheter along or over the guide wire and into or adjacent to the pericardial space; Advance or expose the anchoring member of the anchoring system through or at the distal end of the anchoring member catheter located in the pericardial space, wherein the anchoring member is placed in the pericardial space; Deploy the anchoring member of the anchoring system within the pericardial space and position the anchoring member opposite the epicardium, wherein the anchoring member is in a straight configuration in a pre-deployment configuration via the tension on the first end and the second end of the tether, and wherein the anchoring member is in a loop configuration in a deployment configuration via the tension on the first end and the second end of the tether; and Remove the guide wire and the anchoring member catheter from the patient, leaving the tether that is coupled to the anchoring member in the cardiac chamber of the anchoring system on the guide wire and entering the pericardial space.

12. A mitral chordal repair system, the system comprising: A pericardial anchoring system, the pericardial anchoring system comprising: A pericardial anchoring member including a skirt; A transmyocardial swab; A pericardial anchoring suture coupled to the pericardial anchoring member and the transmyocardial swab; A suture lock; and An anchoring member socket configured to restrain and dock the suture lock, wherein the pericardial anchoring member is configured to be convertible between a pre-deployment configuration and a deployment configuration; and At least one leaflet anchoring member coupled to a leaflet anchoring member suture, wherein the suture lock is configured to secure the pericardial anchoring suture and the leaflet anchoring member suture.

13. The mitral chordal repair system according to claim 12, wherein The pericardial anchoring member is configured to form a disk shape in the deployment configuration.

14. The mitral chordal repair system according to claim 12, wherein The pericardial anchoring member is configured to form a curved shape, a compressed shape, a bundle, a mass, or a knot in the deployment configuration.

15. The mitral chordal repair system according to claim 12, wherein, The pre-deployment configuration includes an elongated configuration, and wherein the deployment configuration includes a compressed configuration.

16. The mitral chord repair system according to claim 12, wherein, The pre-deployment configuration includes an elongated configuration, and wherein the deployment configuration includes a coiled configuration.

17. The mitral chordal repair system according to claim 12, wherein The pericardial anchoring member has a free end in the pre-deployment configuration, wherein the pericardial anchoring member is configured to coil starting from the free end of the pericardial anchoring member to form the deployment configuration.

18. The mitral chordal repair system according to claim 12, characterized in that, The pericardial anchoring member further includes a wire frame, wherein the wire frame is covered by the skirt.

19. The mitral chordal repair system according to claim 18, wherein The wire frame of the pericardial anchoring member has shape memory properties, and its shape is set to the deployment configuration.

20. The mitral chordal repair system according to claim 18, wherein The skirt is configured to slidably receive the pericardial anchoring suture, and wherein the pericardial anchoring suture is operable to be tensioned to tighten the skirt into the deployment configuration.

21. The mitral chordal repair system according to claim 18, wherein The skirt of the pericardial anchor is coupled to the wire frame along an edge of a defined length, wherein the skirt includes a plurality of holes along an edge of the skirt opposite the wire frame, wherein the pericardial anchor sutures are alternately woven through the plurality of holes, and wherein the pericardial anchor sutures are operable to be tensioned to tighten the skirt into the deployed configuration.

22. The mitral chordal repair system according to claim 18, wherein, The wire frame of the pericardial anchor further includes a proximal leg, wherein the proximal leg is configured to remain straight and positioned at the center of the pericardial anchor in the deployed configuration.

23. The mitral chordal repair system according to claim 22, wherein The transmyocardial swab extends from the proximal leg of the pericardial anchor.

24. The mitral chordal repair system according to claim 22, wherein, The proximal leg includes two folded portions of the same wire such that the two portions are parallel to each other.

25. The mitral chordal repair system according to claim 12, wherein, The pericardial anchor is convertible between the pre-deployed configuration and the deployed configuration at least in part due to proximal retraction of the pericardial anchor sutures.

26. The mitral chordal repair system according to claim 18, characterized in that, The pericardial anchor is convertible between the pre-deployed configuration and the deployed configuration at least in part due to the shape memory properties of the wire frame shaped to the deployed configuration.

27. The mitral chordal repair system according to claim 18, wherein Both the first end and the second end of the wire frame include atraumatic ends.

28. The mitral chordal repair system according to claim 12, wherein, The transmyocardial swab includes a membrane having a tubular structure.

29. The mitral chordal repair system according to claim 28, wherein, The pericardial anchor sutures are woven through a plurality of holes that pass through the membrane of the transmyocardial swab.

30. The mitral chord repair system according to claim 12, wherein, The anchor socket includes a self-expanding frame covered with a membrane.

31. A pericardial anchor system, comprising: A pericardial anchor including a skirt; A transmyocardial swab extending from a proximal portion of the pericardial anchor; Pericardial anchor sutures coupled to the pericardial anchor and the transmyocardial swab, A suture lock configured to secure the pericardial anchor sutures; And An anchor socket configured to constrain and dock the suture lock, Wherein the pericardial anchor is configured to be convertible between a pre-deployed configuration and a deployed configuration.

32. The pericardial anchoring system according to claim 31, wherein The pericardial anchor is configured to form a disc shape in the deployed configuration.

33. The pericardial anchoring system according to 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. The pericardial anchoring system according to claim 31, wherein The pre-deployed configuration includes an elongated configuration, and wherein the deployed configuration includes a compressed configuration.

35. The pericardial anchoring system according to claim 31, wherein, The pre-deployed configuration includes an elongated configuration, and wherein the deployed configuration includes a coiled configuration.

36. The pericardial anchoring system according to claim 31, wherein The pericardial anchor has a free end in the pre-deployed configuration, wherein the pericardial anchor is configured to coil from the free end of the pericardial anchor to form the deployed configuration.

37. The pericardial anchoring system according to claim 31, wherein, The pericardial anchor further includes a wire frame, wherein the wire frame is covered by the skirt.

38. The pericardial anchoring system according to claim 37, wherein The wire frame of the pericardial anchor has shape memory properties shaped to the deployed configuration.

39. The pericardial anchoring system according to claim 31, wherein The skirt is configured to slidably receive the pericardial anchor sutures, and wherein the pericardial anchor sutures are operable to be tensioned to tighten the skirt into the deployed configuration.

40. The pericardial anchoring system according to claim 37, wherein The skirt of the pericardial anchor is coupled to the wire frame along an edge of a defined length, wherein the skirt includes a plurality of holes along an edge of the skirt opposite the wire frame, wherein the pericardial anchor sutures are alternately woven through the plurality of holes, and wherein the pericardial anchor sutures are operable to be tensioned to tighten the skirt into the deployed configuration.

41. The pericardial anchoring system according to claim 37, wherein, The wire frame of the pericardial anchor further includes a proximal leg, wherein the proximal leg is configured to remain straight and positioned at the center of the pericardial anchor in the deployed configuration.

42. The pericardial anchoring system according to claim 41, wherein, The transmyocardial swab extends from the proximal leg of the pericardial anchor.

43. The pericardial anchoring system according to claim 41, wherein, The proximal leg includes two folded portions of the same wire such that the two portions are parallel to each other.

44. The pericardial anchoring system according to claim 31, wherein The pericardial anchor is convertible between the pre-deployed configuration and the deployed configuration at least in part due to proximal retraction of the pericardial anchor sutures.

45. The pericardial anchoring system according to claim 37, wherein The pericardial anchor is convertible between the pre-deployed configuration and the deployed configuration at least in part due to the shape memory properties of the wire frame shaped to the deployed configuration.

46. The pericardial anchoring system according to claim 37, wherein, Both the first end and the second end of the wire frame include atraumatic ends.

47. The pericardial anchoring system according to claim 46, wherein The atraumatic end of each of the first end and the second end of the wire frame includes an eyelet.

48. The pericardial anchoring system according to claim 31, wherein The transmyocardial swab includes a membrane having a tubular structure.

49. The pericardial anchoring system according to claim 48, wherein The pericardial anchor sutures are woven through a plurality of holes that pass through the membrane of the transmyocardial swab.

50. A pericardial anchor, comprising: A skirt; And Pericardial anchor sutures coupled to the skirt, Wherein the pericardial anchor is configured to be convertible between a pre-deployed configuration and a deployed configuration.

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

52. The pericardial anchor according to 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. The pericardial anchor according to claim 50, characterized in that, The pre-deployed configuration includes an elongated configuration, and wherein the deployed configuration includes a compressed configuration.

54. The pericardial anchor according to claim 50, wherein, The pre-deployed configuration includes an elongated configuration, and wherein the deployed configuration includes a coiled configuration.

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

56. The pericardial anchor according to claim 50, wherein The pericardial anchor further includes a wire frame, wherein the wire frame is covered by the skirt.

57. The pericardial anchor according to claim 56, wherein The wire frame of the pericardial anchor has shape memory properties shaped to the deployed configuration.

58. The pericardial anchor according to claim 56, wherein, The skirt is configured to slidably receive the pericardial anchor sutures, and wherein the pericardial anchor sutures are operable to be tensioned to tighten the skirt into the deployed configuration.

59. The pericardial anchor according to claim 56, wherein The skirt of the pericardial anchor is coupled to the wire frame along an edge of a defined length, wherein the skirt includes a plurality of holes along an edge of the skirt opposite the wire frame, wherein the pericardial anchor sutures are alternately woven through the plurality of holes, and wherein the pericardial anchor sutures are operable to be tensioned to tighten the skirt into the deployed configuration.

60. The pericardial anchor according to claim 56, wherein, The wire frame of the pericardial anchor further includes a proximal leg, wherein the proximal leg is configured to remain straight and positioned at the center of the pericardial anchor in the deployed configuration.

61. The pericardial anchor according to claim 60, wherein The proximal leg includes two folded portions of the same wire such that the two portions are parallel to each other.

62. The pericardial anchor according to claim 60, wherein, The pericardial anchor can be converted between the pre-deployed configuration and the deployed configuration at least in part due to proximal retraction of the pericardial suture.

63. The pericardial anchor according to claim 56, characterized in that, The pericardial anchor can be converted between the pre-deployed configuration and the deployed configuration at least in part due to the shape memory property of the wire frame shaped to the deployed configuration.

64. The pericardial anchor according to claim 56, wherein Both the first end and the second end of the wire frame include atraumatic ends.

65. The pericardial anchor according to claim 64, wherein, The atraumatic end of each of the first end and the second end of the wire frame includes an eyelet.

66. A method of anchoring a pericardial anchor system, comprising: Advancing a pericardial anchor in a pre-deployed configuration constrained within an anchor catheter into the pericardial space of the heart; Advancing the anchor catheter tangentially in the pericardial space a predetermined distance to allow the pericardial anchor in the pre-deployed configuration to escape; And Retracting the anchor catheter to at least partially deploy the pericardial anchor into a deployed configuration in the pericardial space.

67. The method according to claim 66, wherein The predetermined distance includes at least 10 cm.

68. The method according to claim 66, wherein The anchor catheter is configured to travel in the pericardial space in a medial-lateral direction and / or in a superior-inferior direction.

69. The method according to claim 66, characterized in that, Further comprising positioning the proximal leg of the pericardial anchor between the epicardium and the distal end of the anchor catheter to maintain the position of the pericardial anchor within the pericardial space.

70. The method according to claim 66, wherein Further comprising applying tension to the pericardial suture of the pericardial anchor system to at least partially convert the pericardial anchor to the deployed configuration.

71. The method according to claim 66, wherein The pericardial anchor is further converted to the deployed configuration at least in part due to the shape memory property of the wire frame of the pericardial anchor shaped to the deployed configuration.

72. A method of anchoring a pericardial anchor system, comprising: Advancing a support sheath until it abuts against the heart wall in a heart chamber; Advancing a guide wire through the support sheath such that the distal end of the guide wire advances through the endocardium, myocardium, and epicardium and into the pericardial space; Advancing an anchor sheath and a guide wire sheath together through the support sheath and advancing on the guide wire into the pericardial space to form a perforation through the endocardium, the myocardium, and the epicardium; Maintaining the position of the guide wire sheath while retracting the anchor sheath and the support sheath together to deploy the pericardial anchor of the pericardial anchor system in the pericardial space, wherein the pericardial anchor is in a pre-deployed configuration when positioned within the anchor sheath; Maintaining the position of the anchor sheath while retracting the guide wire sheath to form a T-bar between the proximal leg of the wire frame of the pericardial anchor and the distal end of the anchor sheath; Retract the support member sheath, the anchor member sheath, and the guide wire sheath together until the proximal leg abuts against the epicardial perforation; Maintain the position of the guide wire sheath and retract the anchor member sheath and the support member sheath together to deploy the pericardial anchor; and Apply tension to the pericardial anchor suture of the pericardial anchor system to at least partially convert the pericardial anchor to a deployed configuration.

73. The method of the pericardial anchoring member system as claimed in claim 72, wherein The pericardial anchor is further converted to the deployed configuration at least in part due to the shape memory properties of the wire frame that is shaped to the deployed configuration.

74. The method of the pericardial anchoring member system according to claim 72, wherein, Further includes maintaining the position of the guide wire sheath and retracting the support member sheath and the anchor member sheath to deploy the transmyocardial swab and the anchor socket of the pericardial anchor system, wherein a first portion of the transmyocardial swab is positioned within the perforations of the epicardium, the myocardium, and the endocardium, and a second portion of the transmyocardial swab extends proximally from the perforation of the endocardium.

75. The method of the pericardial anchoring member system as claimed in claim 74, wherein Further includes folding the second portion of the transmyocardial swab against the perforation of the endocardium.

76. The method of an anchored pericardial anchoring system as claimed in claim 74, wherein, Further includes advancing a suture lock into the anchor socket and advancing the suture lock positioned within the anchor socket toward the endocardium to fold the second portion of the transmyocardial swab.

77. The method of the pericardial anchoring member system as claimed in claim 75, wherein The proximal leg of the pericardial anchor covered with a membrane is configured to seal the epicardial perforation, wherein the first portion of the transmyocardial swab is configured to seal the myocardial perforation, and wherein the folded second portion of the transmyocardial swab is configured to seal the endocardial perforation.

78. A tool for placement in the heart wall and pericardial space, the tool operable to provide access from a chamber of the heart to the pericardial space and / or operable as an anchor for a device coupled to the tool, the tool comprising: A body defining a lumen operable to extend through the heart wall; A head located at the distal end of the body, the head operable to extend into the pericardial space, the head including a movable element operable to move from a pre-deployed configuration of a small profile to a deployed configuration of a large profile, the head defining an aperture in fluid communication with the lumen to define an access channel, the access channel operable to provide a fluid passage between the chamber of the heart and the pericardial space; And A base including a holding member operable to hold the base within the heart wall.

79. The tool according to claim 78, characterized in that, When the movable element reaches a large profile in the deployed configuration, the movable element is operable to support the parietal pericardium, and wherein the holding member cooperates to engage the movable element adjacent to the parietal pericardium.

80. The tool according to claims 78 and 79, characterized in that, The movable element includes a dilator member operable to abut the parietal pericardium to expand the pericardial space.

81. The tool according to claims 78 and 79, characterized in that, The aperture is operable to discharge or withdraw fluid or gas from the pericardial space using a device in communication with the lumen.

82. The tool according to claim 78, characterized in that, The aperture is operable as a pressure port operable to measure pressure using a pressure sensing device.

83. The tool according to any one of claims 78 - 82, characterized in that, The access channel is operable to receive a device and permit the device to pass through the access channel between the ventricular side of the heart and the pericardial space.

84. The tool according to any one of claims 78 - 82, characterized in that, The aperture is operable to elastically deform between an open configuration and a closed configuration, wherein in the closed configuration, the access channel is occluded to prevent fluid passage through the access channel.

85. The tool according to any one of claims 78 - 82, characterized in that, The head further includes an occlusion element operable to move elastically between an open position and a closed position, wherein in the closed position, the access channel is occluded to prevent fluid passage through the access channel.

86. The tool according to any one of claims 78 - 82, characterized in that, An occlusion plug is further included, the occlusion plug being operable to be placed in the access channel to occlude the access channel and thereby prevent fluid passage through the access channel.

87. The tool according to any one of claims 78 - 83, characterized in that, The tool is operable to couple to tissue of the heart or other devices.

88. A method of implanting a tool as claimed in any one of claims 78 - 87, the method comprising: providing a delivery system operable for endocardial access, the delivery system including a steerable catheter and a delivery catheter; inserting the delivery system into a patient using a transvenous, transarterial, transseptal, transatrial or transaortic method; advancing the delivery catheter into the myocardium and extending the head of the tool into the pericardial space, the tool being coupled to the delivery catheter.

89. The method according to claim 88, characterized in that, The delivery system further includes a guide wire and / or a needle, the method comprising: advancing the guide wire or the needle through the delivery catheter and extending through the tool into the myocardium and into the pericardial space; and advancing the tool over the guide wire or the needle.

90. A method of mitral chordal repair, the method comprising: locking a suture in 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 the position of the suture lock relative to each of the at least one leaflet anchor sutures; and locking the at least one leaflet anchor suture.

91. The method according to claim 90, wherein Compressing the at least one leaflet anchor to couple mitral valve leaflets is further included.

92. A method of leaflet anchoring, the method comprising: providing a leaflet anchoring system including: at least one leaflet anchor configured to pass through a mitral valve leaflet; and at least one leaflet suture configured to be integral with the at least one leaflet anchor and pass through the mitral valve leaflet; advancing a delivery catheter to a first side of the mitral valve leaflet; advancing a needle through the delivery catheter; extending the needle to pierce the mitral valve leaflet; delivering at least one leaflet anchor integral 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 the position of a suture lock; and withdrawing the delivery catheter.

93. The method according to claim 92, wherein Locking at least one leaflet suture to the suture lock to maintain the tension of the at least one leaflet suture is further included.

94. The method according to claim 92, wherein The at least one leaflet anchor is a swab that includes at least one aperture configured to be integral with the at least one leaflet suture.

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

96. The method according to claim 92, characterized in that, Also included is compressing the at least one leaflet anchor by applying tension to the at least one leaflet suture.

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