Pericardial anchoring system
Patent Information
- Application Number
- EP2024708030
- Authority / Receiving Office
- EP · EP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2023-01-20
- Filing Date
- 2024-01-19
- Publication Date
- 2025-11-26
AI Technical Summary
Current cardiac device anchoring systems lack a secure method for anchoring medical devices within the heart, particularly in the pericardial space, as existing methods often rely on embedding anchors in the myocardium, which may not provide sufficient stability.
A pericardial anchoring system comprising a pericardial anchor with a transmyocardial pledget and suture that transforms from an elongated configuration to a cinched configuration, utilizing a compressing element to secure the pledget and anchor within the pericardial space, ensuring a stable and secure attachment.
The system provides a more secure and stable anchoring solution within the pericardial space, minimizing tissue trauma and preventing device migration, while allowing for independent operation of the anchor and pledget configurations for optimal deployment and sealing.
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Abstract
Description
PERICARDIAL ANCHORING SYSTEMCROSS-REFERENCE TO RELATED APPLICATION
[0001] This application claims the benefit of Provisional Application No. 63 / 480,929, filed January 20, 2023, which is incorporated herein by reference in its entirety for all purposes.FIELD
[0002] The present disclosure relates generally to cardiac device anchoring and more specifically to apparatuses, systems, and methods that include accessing and anchoring in the pericardial space.BACKGROUND
[0003] There is a need for anchoring medical devices in the chambers of the heart. Commonly, these devices may have an anchor that is imbedded in the myocardium. There remains a need for a more secure anchoring system for such devices.SUMMARY
[0004] Described embodiments are directed to apparatus, system, and methods for pericardial anchoring.
[0005] According to one example (“Example 1”), a pericardial anchoring system, comprises: a pericardial anchor; a transmyocardial pledget extending from a proximal end of the pericardial anchor; and a transmyocardial pledget suture coupled to the transmyocardial pledget and operable to upon application of tension to an end of the transmyocardial pledget suture transform the transmyocardial pledget from an elongated configuration to a cinched configuration defining a shortened dimension in a longitudinal direction.
[0006] In accordance with another example (“Example 2”), the pericardial anchoring system of Example 1 , wherein the transmyocardial pledget suture is operable to upon application of tension to an end of the transmyocardial pledget suture transform the transmyocardial pledget from an elongated configuration to a cinched configuration defining an enlarged dimension transverse to the longitudinal direction.
[0007] In accordance with another example (“Example 3”), the pericardialanchoring system of Example 1 or Example 2, wherein the transmyocardial pledget includes a plurality of pledget apertures located along a length of the transmyocardial pledget, the transmyocardial pledget suture extending sequentially through the plurality of pledget apertures.
[0008] In accordance with another example (“Example 4”), the pericardial anchoring system of Example 3, wherein the transmyocardial pledget suture is woven sequentially through the plurality of pledget apertures and sequentially located adjacent a transmyocardial pledget first side and a transmyocardial pledget second side that is opposite the transmyocardial pledget first side.
[0009] In accordance with another example (“Example 5”), the pericardial anchoring system of Example 3 and 4, wherein the transmyocardial pledget suture sequentially traverses through the plurality of pledget apertures from a transmyocardial pledget distal end to a transmyocardial pledget proximal end and back to the transmyocardial pledget distal end, wherein the transmyocardial pledget proximal end is adjacent the pericardial anchor.
[0010] In accordance with another example (“Example 6”), the pericardial anchoring system of any of the Examples 3-5, wherein the transmyocardial pledget suture includes a transmyocardial pledget suture first end and a transmyocardial pledget suture second end opposite the transmyocardial pledget suture first end, wherein the transmyocardial pledget suture first end includes a compressing element, the compressing element having a dimension that prevents the compressing element from passing through a first aperture of the plurality of pledget apertures, the compressing element operable to engage with and compress the transmyocardial pledget when tension is applied to the transmyocardial pledget suture second end.
[0011] In accordance with another example (“Example 7”), the pericardial anchoring system of Example 6, wherein the compressing element is a knot defined by the transmyocardial pledget suture first end.
[0012] In accordance with another example (“Example 8”), the pericardial anchoring system of any of Examples 6 and 7, wherein the compressing element is configured to translate along the transmyocardial pledget suture second end.
[0013] In accordance with another example (“Example 9”), the pericardialanchoring system of Example 6, wherein the compressing element is the transmyocardial pledget suture first end defining a knot and a loop operable to slidingly receive the transmyocardial pledget suture second end therethrough.
[0014] In accordance with another example (“Example 10”), the pericardial anchoring system of Example 6, wherein the compressing element is a loop coupled to the transmyocardial pledget suture first end with the transmyocardial pledget suture second end slidingly receive therethrough.
[0015] In accordance with another example (“Example 11”), the pericardial anchoring system of Example 10, wherein the loop is a ring.
[0016] In accordance with another example (“Example 12”), the pericardial anchoring system of any of Examples 8-11 , wherein translation of the compressing element along the transmyocardial pledget suture second end in a direction towards the pericardial anchor is configured to cinch the transmyocardial pledget.
[0017] In accordance with another example (“Example 13”), the pericardial anchoring system of any of Examples 8-12, comprises a suture tail, the suture tail being integral with or coupled to the compressing element, wherein the transmyocardial pledget suture is operable to be removed from the transmyocardial pledget upon application of tension to the suture tail in a direction away from the pericardial anchor with the transmyocardial pledget suture slidingly removed from the plurality of pledget apertures.
[0018] In accordance with another example (“Example 1 ”), the pericardial anchoring system of any of Examples 2-12, wherein a pledget aperture distance between at least two pledget apertures is larger than a largest transverse dimension of the transmyocardial pledget operable to fold the transmyocardial pledget to a larger dimension in a transverse direction when in the cinched configuration relative to a pledget largest transverse dimension when in the elongated configuration when tension is applied to the transmyocardial pledget suture second end.
[0019] In accordance with another example (“Example 15”), the pericardial anchoring system of any of Examples 2-14, wherein a pledget aperture distance between at least two pledget apertures is larger than twice largest transverse dimension of the transmyocardial pledget operable to fold the transmyocardial pledget to a largerdimension in a transverse direction when in the cinched configuration relative to a pledget largest transverse dimension when in the elongated configuration when tension is applied to the transmyocardial pledget suture second end.
[0020] In accordance with another example (“Example 16”), the pericardial anchoring system of any of Examples 2-15, wherein the plurality of pledget apertures are not colinearly located along the longitudinal direction of the transmyocardial pledget operable to fold the transmyocardial pledget to a larger dimension in a transverse direction when in the cinched configuration relative to the largest transverse dimension of the transmyocardial pledget when in the elongated configuration when tension is applied to the transmyocardial pledget suture second end.
[0021] In accordance with another example (“Example 17”), the pericardial anchoring system of any of Examples 1 -16, The pericardial anchoring system of any one of Claims 1 -16, further comprises: a pericardial anchoring suture coupled to the pericardial anchor; a suture lock configured to interact with the pericardial anchoring suture; and an anchor socket configured to house the suture lock.
[0022] In accordance with another examples (“Example 18”), a pericardial anchoring system, comprises: a pericardial anchor; a transmyocardial pledget extending from a proximal portion of the pericardial anchor; a pericardial anchoring suture coupled to the pericardial anchor; a transmyocardial pledget suture coupled to the transmyocardial pledget; a suture lock configured to interact with the pericardial anchoring suture; and an anchor socket configured to house the suture lock, wherein the pericardial anchor is operable to be transformable between a pre-deployed configuration and a deployed configuration, wherein the transmyocardial pledget is operable to be transformable between a pre-cinched configuration and a cinched configuration, wherein the transmyocardial pledget and the pericardial anchor are independently operable.
[0023] In accordance with another example (“Example 19”), the pericardial anchoring system of Example 18, wherein the anchor socket is further configured to constrain and dock the suture lock.
[0024] In accordance with another example (“Example 20”), the pericardial anchoring system of Example 18, wherein the suture lock secures the pericardialanchoring suture.
[0025] In accordance with another example (“Example 21”), the pericardial anchoring system of Example 18, wherein the transmyocardial pledget includes a plurality of apertures located along a length of the transmyocardial pledget.
[0026] In accordance with another example (“Example 22”), the pericardial anchoring system of Example 21 , wherein the transmyocardial pledget suture is woven through the plurality of apertures.
[0027] In accordance with another example (“Example 23”), the pericardial anchoring system of Example 21 , wherein the transmyocardial pledget suture is woven through the plurality of apertures from a distal end to a proximal end and back to a distal end.
[0028] In accordance with another example (“Example 24”), the pericardial anchoring system of Example 18, wherein the transmyocardial pledget is configured to form a cinched shape, a bunch, or a wad in the cinched configuration.
[0029] In accordance with another example (“Example 25”), the pericardial anchoring system of Example 18, wherein the transmyocardial pledget suture includes a compressing element.
[0030] In accordance with another example (“Example 26”), the pericardial anchoring system of Example 25, wherein the compressing element is configured to translate along the transmyocardial pledget suture.
[0031] In accordance with another example (“Example 27”), the pericardial anchoring system of Example 25, wherein the compressing element is configured to translate along a second end of the transmyocardial pledget suture.
[0032] In accordance with another example (“Example 28”), the pericardial anchoring system of Example 25, wherein a first end of the transmyocardial pledget suture is slidingly received through the compressing element operable to translate along a second end of the transmyocardial pledget suture.
[0033] In accordance with another example (“Example 29”), the pericardial anchoring system of Example 26, wherein translation of the compressing element along the transmyocardial pledget suture in a direction towards the pericardial anchor is configured to cinch the transmyocardial pledget.
[0034] In accordance with another example (“Example 30”), the pericardial anchoring system of Example 25, wherein the compressing element is a non-slip loop knot.
[0035] In accordance with another example (“Example 31”), the pericardial anchoring system of Example 25, wherein the compressing element applies pressure to a surface of the transmyocardial pledget to transform the transmyocardial pledget to the cinched configuration.
[0036] In accordance with another example (“Example 32”), the pericardial anchoring system of Example 31 , , wherein a minimal tension is applied to the transmyocardial pledget suture when the transmyocardial pledget is in the cinched configuration.
[0037] In accordance with another example (“Example 33”), the pericardial anchoring system of Example 21 , wherein a predetermined resistance between the transmyocardial pledget suture and the plurality of pledget apertures is operable to prevent relative movement with the transmyocardial pledget in the cinched configuration.
[0038] In accordance with another example (“Example 34”), the pericardial anchoring system of Example 31 , wherein translation of the compressing element along the transmyocardial pledget suture in a direction away from the pericardial anchor minimally effects the cinched configuration of the transmyocardial pledget.
[0039] In accordance with another example (“Example 35”), the pericardial anchoring system of Example 25, wherein the compressing element is a miniature pledget.
[0040] In accordance with another example (“Example 36”), the pericardial anchoring system of Example 25, wherein the compressing element is a compression sleeve.
[0041] In accordance with another example (“Example 37”), a method of deploying a pericardial anchor system, comprises: applying tension to a pericardial anchor suture woven through a pericardial anchor to deploy; translating a compressing element along a pledget suture woven through a transmyocardial pledget in a precinched configuration to transform the transmyocardial pledget to a cinchedconfiguration; and locking the transmyocardial pledget in the cinched configuration.
[0042] In accordance with another example (“Example 38”), the pericardial anchoring system of Example 37, the compressing element applies pressure to a surface of the transmyocardial pledget to transform the transmyocardial pledget to the cinched configuration.
[0043] In accordance with another example (“Example 39”), the pericardial anchoring system of Example 37, wherein a predetermined resistance locks the transmyocardial pledget in the cinched configuration.
[0044] In accordance with another example (“Example 40”), the pericardial anchoring system of Example 37, wherein the compressing element is translated in a direction towards the pericardial anchor to transform the transmyocardial pledget to the cinched configuration.
[0045] In accordance with another example (“Example 41”), the pericardial anchoring system of Example 37, wherein minimal tension is applied to the pledget suture when the transmyocardial pledget is in the cinched configuration.
[0046] In accordance with another example (“Example 42”), the pericardial anchoring system of Example 37, further comprising routing the pericardial anchor suture and the pledget suture through a suture lock within an anchor socket connected to the transmyocardial pledget.
[0047] In accordance with another example (“Example 43”), the pericardial anchoring system of Example 37, wherein deployment of the pericardial anchor includes formation of a disc.
[0048] In accordance with another examples (“Example 44”), a method of mitral valve chord repairment, the method comprises: anchoring a pericardial anchor by applying tension to a pericardial anchor suture integrated with the pericardial anchor; cinching a transmyocardial pledget by translating a compressing element along a pledget suture integrated with the transmyocardial pledget; connecting the pericardial anchor suture, the pledget suture, and at least one leaflet anchor suture integrated with at least one leaflet anchor to a suture lock within an anchor socket that is connected to the transmyocardial pledget; locking the pericardial anchor suture to the suture lock; and locking the at least one leaflet anchor suture.
[0049] In accordance with another example (“Example 45”), the pericardial anchoring system of Example 44, wherein the compressing element is translated in a direction towards the pericardial anchor to transform the transmyocardial pledget to a cinched configuration.
[0050] In accordance with another example (“Example 46”), the pericardial anchoring system of Example 45, wherein minimal tension is applied to the pledget suture when the transmyocardial pledget is in the cinched configuration.
[0051] In accordance with another example (“Example 47”), the pericardial anchoring system of Example 45, wherein a preferred resistance maintains the transmyocardial pledget in the cinched configuration.BRIEF DESCRIPTION OF THE DRAWINGS
[0052] The accompanying drawings are included to provide a further understanding of the disclosure and are incorporated in and constitute a part of this specification, illustrate embodiments, and together with the description serve to explain the principles of the disclosure.
[0053] FIG. 1 A is a side view of an anchor system, in accordance with an embodiment;
[0054] FIG. 1 B is a side view of the anchor system of FIG. 1 A;
[0055] FIG. 2A is a cross-sectional view of a heart;
[0056] FIG. 2B is a close-up cross-sectional view of the heart of FIG. 2A;
[0057] FIG. 3 is a cross-sectional view of a heart with a guidewire in accordance with an embodiment of the method of providing a pericardial anchoring system;
[0058] FIG. 4 is a cross-sectional view of a heart with a guidewire in accordance with an embodiment of the method of providing a pericardial anchoring system;
[0059] FIG. 5A is a cross-sectional view of a heart with a guidewire in accordance with an embodiment of the method of providing a pericardial anchoring system;
[0060] FIG. 5B is a cross-sectional view of a heart with a guidewire in accordance with an embodiment of the method of providing a pericardial anchoring system;
[0061] FIG. 6 is a cross-sectional view of a heart with a guidewire and needle catheter in accordance with an embodiment of the method of providing a pericardial anchoring system;
[0062] FIG. 7 is a cross-sectional view of a heart with a guidewire and needle catheter in accordance with an embodiment of the method of providing a pericardial anchoring system;
[0063] FIG. 8 is a cross-sectional view of a heart with a guidewire and catheter in accordance with an embodiment of the method of providing a pericardial anchoring system;
[0064] FIG. 9 is a cross-sectional view of a heart with a catheter and an anchoring system in accordance with an embodiment of the method of providing a pericardial anchoring system;
[0065] FIG. 10 is a cross-sectional view of a heart with a catheter and an anchoring system that has been deployed in accordance with an embodiment of the method of providing a pericardial anchoring system;
[0066] FIG. 11 is a cross-sectional view of a heart with an anchoring system that has been deployed in accordance with an embodiment of the method of providing a pericardial anchoring system;
[0067] FIG. 12 is a cross-sectional view of a heart with an anchoring system that has been deployed with a sealing means, in accordance with an embodiment of the method of providing a pericardial anchoring system;
[0068] FIG. 13 is a cross-sectional view of a heart with an anchoring system that has been deployed with a tether lock, in accordance with an embodiment of the method of providing a pericardial anchoring system;
[0069] FIG. 14 is a cross-sectional view of a heart with an anchoring system that has been deployed and coupled to a mitral valve leaflet to prevent prolapse, in accordance with an embodiment of the method of providing a pericardial anchoring system;
[0070] FIG. 15 is a flow diagram of an embodiment of a method of providing a pericardial anchoring system;
[0071] FIG. 16 is a flow diagram of an embodiment of a method of providing a pericardial anchoring system;
[0072] FIG. 17 is a flow diagram of an embodiment of a method of providing a pericardial anchoring system;
[0073] FIG. 18 is an example of a pericardial anchoring system in a laid open configuration, in accordance with an embodiment.
[0074] FIG. 19 is an example of the pericardial anchoring system of FIG. 21 wherein the pericardial anchor is in the deployed configuration and the transmyocardial pledget in a predeployed configuration.
[0075] FIG. 20 is an example of the pericardial anchoring system of FIGs. 21 and 22 in a fully deployed configuration.
[0076] FIG. 21 A is an example of the wire frame of the pericardial anchor in a deployed configuration, in accordance with an embodiment.
[0077] FIG. 21 B is an example of the transmyocardial pledget having a t-bar proximal leg.
[0078] FIG. 22 is an example embodiment of the transmyocardial pledget in a pre-cinched configuration.
[0079] FIG. 23 is a zoomed-in view of an example embodiment of the compressing element.
[0080] FIG. 24 is a zoomed-in view of an example embodiment of the compressing element.
[0081] FIG. 25A is a back view of an example embodiment of the pledget suture path.
[0082] FIG. 25B is a front view of an example embodiment of the pledget suture path.
[0083] FIG. 26 is an example embodiment of the transmyocardial pledget in a cinched configuration.
[0084] FIG. 27A is an example embodiment of the pledget suture.
[0085] FIG. 27B is a zoomed in view of an example embodiment of the compressing element.
[0086] FIG. 28 is an example embodiment of the pericardial anchor system.
[0087] FIG. 29 is an isometric view of an example embodiment of the pledget.
[0088] FIG. 30 is a top view of an example embodiment of the pledget.
[0089] FIG. 31 A is a top view of an example embodiment of the pledget.
[0090] FIG. 31 B is a side view of an example embodiment of the pledget.
[0091] FIG. 31 C is an isometric view of an example embodiment of the pledget.
[0092] FIG. 31 D is a zoomed-in view of an example embodiment of the compressing element.
[0093] FIG. 32A is a top view of an example embodiment of the pledget.
[0094] FIG. 32B is a side view of an example embodiment of the pledget.
[0095] FIG. 32C is an isometric view of an example embodiment of the pledget.
[0096] FIG. 32D is a zoomed-in view of an example embodiment of the compressing element.
[0097] FIG. 33A is an example embodiment of the miniature pledget.
[0098] FIG. 33B is an example embodiment of the miniature pledget.
[0099] FIG. 33C is an example embodiment of the miniature pledget.[000100] FIG. 33D is an example embodiment of the miniature pledget.[000101 ] FIG. 34 is an example of the pericardial anchoring system and a leaflet anchoring system deployed and implanted in the heart in accordance with an embodiment.[000102] FIG. 35A is an example of the leaflet anchor implanted in the valve leaflet and the leaflet anchor suture extending between the leaflet anchor and the pericardial anchoring system implanted in the ventricular wall, in accordance with an embodiment. [000103] FIG. 35B is a cross sectional view of the ventricular wall with the pericardial anchoring system implanted, in accordance with an embodiment.[000104] FIG. 35C is a view of the pericardial anchor implanted within the pericardial cavity (not showing the pericardium for clarity), in accordance with an embodiment.DETAILED DESCRIPTION[000105] Persons skilled in the art will readily appreciate that various aspects of the present disclosure can be realized by any number of methods and apparatus configured to perform the intended functions. It should also be noted that the accompanyingdrawing figures referred to herein are not necessarily drawn to scale, but may be exaggerated to illustrate various aspects of the present disclosure, and in that regard, the drawing figures should not be construed as limiting.[000106] Although the embodiments herein may be described in connection with various principles and beliefs, the described embodiments should not be bound by theory. For example, embodiments are described herein in connection with mitral valve leaflet prolapse prevention by way of an anchoring system that is contained within the pericardial space. However, embodiments within the scope of this disclosure can be applied toward any prosthesis or mechanism of similar structure and / or function that requires anchoring within the chambers of the heart.[000107] Embodiments herein include various apparatuses, systems, and methods for a suture or other tether mechanism having an anchor that lies within the pericardial space, with the suture extending through the myocardium and endocardium for use to couple with a biological element, such as a mitral valve leaflet, or to a prosthesis, such as, but not limited to, a sensor or support structure. The anchor that lies within and adjacent to the epicardium (visceral layer of serous pericardium) may be of any suitable structure, such as, but not limited to, an umbrella-like element, a pledget, a multi-legged support structure, and the like. The anchor is operable to have a low profile so as to be able to pass through a narrow access channel in the heart wall and expand or deploy to a larger diameter or surface area within the pericardial space and not pass through the narrow access channel in the heart structure. The present disclosure relates to mitral valve repair or replacement and more generally to methods and devices for mitral valve reshaping, repair and / or replacement of mitral chords, also referred to as chordae tendineae, to restore proper functioning of the mitral valve from a state of malfunction, such as, but not limited mitral valve regurgitation.[000108] The term “heart wall”, as used herein, is defined as the endocardium, myocardium and epicardium.[000109] The terms "pericardial space" and “pericardial cavity”, as used herein, is that space defined by the heart wall and the pericardium, therebetween, or the space between the visceral pericardium and the parietal pericardium.[000110] The term “coupled”, as used herein, means joined, connected, attached, adhered, affixed, or bonded, whether directly or indirectly, and whether permanently or temporarily.[000111 ] The term “pericardial anchor” is used herein to describe the anchor of the pericardial anchoring system, however, the anchor of the pericardial system can also be referred to as an pericardial anchor or an anchor.[000112] In accordance with embodiments, and as provided in FIG. 17, pericardial anchoring is provided by way of a small hollow needle catheter (e.g., 20-25 gauge) and a compatible guidewire (e.g., 0.010” - 0.018”, operable to fit through the lumen of the needle catheter). Heart wall crossing from within a heart chamber is initiated by the needle catheter passing through the endocardium and into the myocardium, and completed by a guidewire passing through the remainder of the myocardium and through the epicardium. The guidewire is placed into the pericardial space so that an anchor of an anchor system can subsequently be delivered over the guidewire and into the pericardial space.[000113] Due to extremely small profile the risk of adverse events may be lowered, such as, unlikely to cause pericardial effusion / tamponade.[000114] Crossing the epicardium with a guidewire instead of a needle catheter may result in an increase in safety and also procedural ease-of-use by, for example, taking out guesswork / ambiguity of getting into the pericardial space for being not too short or too far, since imaging of this space and / or knowing placement in the pericardial space is challenging. The selection of guidewire stiffness, for example, is optimized, both at distal tip and along entire length, such that, but not limited to, the distal tip being stiff enough that it may cross the remainder of the heart wall and into the pericardial space, but soft enough so as to deflect and not puncture the pericardium (parietal layer of serous pericardium and fibrous pericardium). The guidewire is operable to coil up within the pericardial space and track within the pericardial space. Advancement of the guidewire distal end within the pericardial space and adjacent to the heart wall may provide the clinician evidence that the distal end of the guidewire is in the pericardial space.[000115] Wherein the guidewire outer diameter is just slightly less than needle inner diameter, potential coring out of the heart wall is mitigated or minimize so as to reduce tissue trauma. The needle catheter and guidewire may be introduced together with the guidewire distal tip just slightly pulled back relative to needle catheter distal tip, i.e. , nested or in tandem. Subsequent to the needle catheter puncturing the endocardium, the guidewire may be advanced beyond needle catheter distal tip with the needle catheter providing support for the guidewire.[000116] It is appreciated that there are different ways to advance the small hollow needle catheter and subsequently the nested guidewire to a target location. In one embodiment, the needle catheter may be advanced over a previously placed guidewire, in an over-the-wire procedure, such as, but not limited to, from an access port in the femoral vein. In other embodiments, the needle catheter with or without a nested guidewire, may be advanced through a lumen of a previously-placed steerable or nonsteerable sheath, support / guide catheters, and the like.[000117] It is appreciated that subsequent to the guidewire crossing into the pericardial space, there may be some additional steps required to be performed prior to advancement of the anchoring system. By way of example, but not limited thereto, utilization of contrast agents, CO2, microcatheters, various guidewires, support / guide catheters, and other devices, agents, and therapeutics may be used for a particular purpose. Such devices, agents and therapeutics may be provided so as, but not limited to, creating physical space in the pericardial space at the target location, visualizing the pericardial space and / or heart / pericardium structures at the target location, ensuring adequate purchase of a suitability stiff and correct diameter guidewire in the pericardium to deliver the anchoring system.[000118] In accordance with embodiments, diagnostic modalities may be employed so as to provide evidence of guidewire crossing the heart wall and into the pericardial space. By way of example, such diagnostic modalities may include, but not limited thereto, a guidewire attached to an ECG lead (such as a guidewire having a non- electrically conductive coating except for a proximal and distal tip), and a pressuresensing guidewire with a sensing element at the distal tip. Data gathered from thesemodalities may provide evidence of guidewire crossing the heart wall and into the pericardial space.PERICARDIAL ANCHORING SYSTEM[000119] FIGS. 1 A and 1 B are side views 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 low profile 33 in a first position 36 and a larger profile 37 in a second position 38. The anchor 32 is operable to be advanced into a pericardial space 10 from a heart chamber 6 of a heart 2 through a narrow access channel 12 in a heart wall 41 in the first position 36 and expand to the second position 38 in the pericardial space 10 to a size greater than the narrow access channel 12.[000120] FIGS. 2A and 2B are cross-sectional views of the heart 2 and its corresponding anatomical features.GUIDEWIRE ADVANCEMENT / INSERTION[000121 ] FIGS. 3-14 are a series of illustrations, and FIG. 15 a flow diagram, of a method of providing an anchor 32 in a heart chamber 6, in accordance with an embodiment. A femoral vein is accessed and a guidewire 40 is advance therein. The guidewire 40 is advanced through the femoral vein, and into the right atrium 20, FIG. 3. The guidewire 40 is advanced through the septum 26 and into the left atrium 24, FIG. 4. The guidewire 40 is advanced through the mitral valve 8 and advanced up to and adjacent the heart wall 41 of the left ventricle 22, FIGS. 5A and 5B. A needle catheter 42 is advanced over the guidewire 40 and into about half of the thickness 16 of the myocardium 13, FIG. 6. The guidewire 40 having a stiff distal tip is advanced through the needle catheter 42 through the epicardium 14 and into the pericardial space 10, FIG. 7. The length of the guidewire that is advanced into the pericardial space 10 may be minimized. The guidewire may be configured to coil or obtain a coiled shape upon advancement into the pericardial space 10. It may be advantageous to minimize the length of the guidewire that is inserted into the pericardial space 10 to preserve the integrity of the heart wall. A catheter 44 is advanced over the guidewire 40 and into the pericardial space 10, FIG. 8. A gas, such as carbon dioxide, may be used to inflate and separate the pericardium 18 from the heart wall 41 , enlarging the pericardial space 10. An anchoring system 30 can be advanced over the guidewire 40 after removing thecatheter 44, and / or it can be advanced through the catheter 44 after removing the guidewire 40, Fig. 9, or advanced over the guidewire 40 while the guidewire 40 remains in the catheter 44. The anchoring system 30 may be facilitated by an anchoring system delivery catheter operable to deliver and deploy the anchoring system. An anchor is deployed within the pericardial space 10 and placed so as to oppose the epicardium 14, FIG. 10. The anchoring system 30 includes a suture or tether 34 that is coupled to the anchor 32 with the suture or tether 34 remaining in the heart chamber 6, FIG. 11 . [000122] It is anticipated that once the delivery system, that is, any guidewire 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 needed to prevent the transfer of blood from the left ventricle into the pericardial space that may be caused by forming the access channel 12. It is anticipated that optionally, a sealing means 48 may be provided to reduce or eliminate potential transfer of blood from the left ventricle into the pericardial space. Such sealing means 48 may include, but not limited to, a surface texture on the tether 34 so as to induce a healing response between the tether 34 and the heart wall 41 , a pledget along the tether 34 that may be used to plug the access channel 12, an expandable portion or element about the tether 34 and / or the anchor 32 that is operable to close the access channel 12 about the tether 34 and / or anchor, FIG. 12.[000123] In some embodiments, there may be three levels of sealing that may take place upon removal of the delivery system from the access channel. The access channel may be sealed from the inside of the epicardium, outside the epicardium, and through the access channel into the epicardium. The size of the delivery system may affect the amount or degree of sealing that may occur after the removal of the delivery system. In some embodiments, the smaller the delivery system the easier it may be to achieve the three levels of sealing and return the epicardium to a pre-injury state. [000124] In another embodiment, illustrated in FIG. 13, a tether lock 35 is advanced over the tether 34 and in abutment with the endocardium 11 operable to engage the tether 34 and hold fast so as to capture the heart wall 41 between the tether lock 35 and the anchor. Such a tether lock 35 may be operable to ensure urging engagement of theanchor 32 with the endocardium 11 so as to prevent movement thereof, so as to, for example, prevent any subsequent irritation to the pericardium 18.[000125] As provided before, the suture or tether 34 may be used for a particular purpose. In accordance with an embodiment, the suture or tether 34 is coupled to a mitral valve leaflet 9 so as to prevent the leaflet from prolapsing, illustrated in FIG. 14. [000126] In accordance with another embodiment, the suture or tether 34 may be coupled to a device, such as a prosthetic valve.[000127] In accordance with another embodiment, the suture or tether 34 may be coupled to a device, such as a sensor.ANCHOR DEPLOYMENT OVERVIEW[000128] In accordance with another embodiment, as provided in the flow diagram of FIG. 16, and referring to FIGS. 1-14 for reference, a method of anchoring includes advancing a guidewire 40 into a heart 2 up to and adjacent a heart wall 41 . The length of the guidewire that is advanced into the pericardial space 10 may be minimized. The guidewire may be configured to coil or obtain a coiled shape upon advancement into the pericardial space 10. It may be advantageous to minimize the length of the guidewire that is inserted into the pericardial space 10 preserve the integrity of the heart wall. A needle catheter 42 is advanced over the guidewire 40 and into about half of a thickness 16 of the heart wall 41 . The guidewire 40 is advanced through the needle catheter 42 through an epicardium 14 and into a pericardial space 10. The needle catheter 42 is withdrawn from the guidewire 40. A catheter 44 is advanced over the guidewire 40 and into the pericardial space 10. The pericardium 18 is separated from the heart wall 41 so as to enlarge the pericardial space 10. An anchoring system 30 is advanced either over the guidewire 40 or through the catheter 44, an anchor portion 39 of which placed into the pericardial space 10. An anchor 32 of the anchoring system 30 is deployed within the pericardial space 10 and placed so as to oppose the epicardium 14. The guidewire 40 and / or catheter 44 is removed from a patient leaving a tether 34 that is coupled to the anchor 32 in a heart chamber 6.[000129] In accordance with another embodiment, a method of anchoring includes optionally advancing a support catheter into a heart near or up to and adjacent to or against a heart wall. An anchoring catheter is advanced singularly or through theoptional support catheter and placed near or in urging engagement against the heart wall. A guidewire is advanced through the anchor catheter through an endocardium through a myocardium and through an epicardium (visceral layer of serous pericardium) of the heart wall and into a pericardial space. The anchor catheter is advanced over the guidewire and through the endocardium through the myocardium and through the epicardium (visceral layer of serous pericardium) of the heart wall and into the pericardial space. Optionally, the guidewire is withdrawn from the pericardial space. Optionally the pericardium is separated from the epicardium so as to enlarge the pericardial space. An anchor of an anchoring system is advanced or exposed through or at or near a distal end of the anchor catheter which is 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 so as to oppose the epicardium. The guidewire and / or anchor catheter and / or support catheter are removed from a patient leaving a tether that is coupled to the anchor in a heart chamber.[000130] In accordance with another embodiment of a method of anchoring includes advancing an anchor catheter near or up to and against a heart wall in a heart chamber. A guidewire is advanced through the anchoring catheter such that a guidewire distal tip advances through an endocardium and into a myocardium through the epicardium and into a pericardial space. A distal tip of the anchor catheter is advanced along or over the guidewire and into or adjacent to the pericardial space. An anchor of an anchoring system is advanced or exposed through or at a distal end of the anchor catheter which is 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 so as to oppose the epicardium. The guidewire and / or anchor catheter are removed from a patient leaving a tether that is coupled to the anchor in a heart chamber of an anchoring system over the guidewire and into the pericardial space.METHOD OF ANCHORING[000131 ] A method of anchoring, in accordance with an embodiment, comprises providing the anchoring system as described above, advancing a guidewire into afemoral vein, advancing the guidewire through the femoral vein and into a right atrium, advancing the guidewire through a septum and into a left atrium, advancing the guidewire through a mitral valve up to and adjacent a heart wall of a left ventricle, advancing a needle catheter over the guidewire and through an endocardium and into a myocardium of the heart wall, advancing the guidewire through the needle catheter through the myocardium and through an epicardium and into a pericardial space, withdrawing the needle catheter from the guidewire, advancing a catheter over the guidewire and into the pericardial space, inflating and separating a pericardium from the heart wall so as to enlarge the pericardial space, advancing the anchoring system either over the guidewire or through the catheter, the anchor of which is placed into the pericardial space, deploying an anchor of the anchoring system within the pericardial space and placing the anchor so as to oppose the epicardium, wherein the anchor is in a straight configuration in a pre-deployment configuration via tension on the tether first end and tether second end, and wherein the anchor is in a ring configuration in a deployed configuration via tension on the tether first end and tether second end, and removing the guidewire and / or catheter from a patient leaving a tether that is coupled to the anchor in a heart chamber.[000132] A method of anchoring, in accordance with an embodiment, comprises providing the anchoring system as described above, advancing a guidewire into a needle catheter such that a guidewire distal tip is adjacent to a needle catheter distal tip, advancing the needle catheter distal tip from a heart chamber through an endocardium and into a myocardium of a heart wall, advancing the guidewire distal tip through the myocardium and the epicardium and into a pericardial space, and advancing the anchor of the anchoring system over the guidewire and into the pericardial space, and deploying the anchor in the pericardial space, wherein the anchor is in a straight configuration in a pre-deployment configuration via tension on the tether first end and tether second end, and wherein the anchor is in a ring configuration in a deployed configuration via tension on the tether first end and tether second end.[000133] A method of anchoring, in accordance with an embodiment, comprises providing the anchoring system as described above, advancing a support catheter into a heart up to and adjacent to or against a heart wall, advancing an anchoring cathetersingularly or through the support catheter and placing in urging engagement against the heart wall, advancing a guidewire along or through the anchor catheter through an endocardium through a myocardium and through an epicardium (visceral layer of serous pericardium) of the heart wall and into a pericardial space, advancing the anchor catheter along or over the guidewire and through the endocardium through the myocardium and through the epicardium (visceral layer of serous pericardium) of the heart wall and into the pericardial space, advancing or exposing the anchor of the anchoring system through or at a distal end of the anchor catheter which is in the pericardial space, wherein the anchor is placed into the pericardial space, deploying the anchor of the anchoring system within the pericardial space and placing the anchor so as to oppose the epicardium, wherein the anchor is in a straight configuration in a predeployment configuration via tension on the tether first end and tether second end, and wherein the anchor is in a ring configuration in a deployed configuration via tension on the tether first end and tether second end, and removing the guidewire and anchor catheter from a patient leaving a tether that is coupled to the anchor in a heart chamber. [000134] A method of anchoring, in accordance with an embodiment, comprises providing the anchoring system as described above advancing an anchor catheter up to and against a heart wall in a heart chamber, advancing a guidewire through the anchoring catheter such that a guidewire distal tip advances through an endocardium and into a myocardium through the epicardium and into a pericardial space, advancing a distal tip of the anchor catheter along or over the guidewire and into or adjacent to the pericardial space, advancing or exposing the anchor of the anchoring system through or at a distal end of the anchor catheter which is 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 so as to oppose the epicardium, wherein the anchor is in a straight configuration in a pre-deployment configuration via tension on the tether first end and tether second end, and wherein the anchor is in a ring configuration in a deployed configuration via tension on the tether first end and tether second end, and removing the guidewire and anchor catheter from a patient leaving a tether that is coupled to the anchor in a heart chamber of an anchoring system over the guidewire and into the pericardial space.SKIRT OF ANCHOR WITH WIRE FRAME[000135] The pericardial anchor 220 can include a wire or wire frame 222 that is coupled to a skirt 230. FIG. 21 is a plan view of a wire frame 222 that is in an unrestrained curved configuration in accordance with an embodiment. The wire or wire frame 222 can be made of nitinol, such as platinum filled nitinol. The skirt 230 or film, as shown in FIG. 18, can be any suitable biocompatible material, such as, but not limited to, a fluoropolymer film such as expanded polytetrafluoroethylene (ePTFE) and expanded polyethylene (ePE). The skirt 230 can have properties operable to facilitate tissue ingrowth. The material of the skirt 230 can have additional properties, such as flexibility and durability to withstand formation of the disc. For example, the material of the skirt 230 can be resistant to breakage or ripping during formation of the disc.[000136] The skirt 230 may include a material that is suitable for a particular purpose. For example, the material of the skirt 230 can be suitably flexible, or has a compliance, so as to facilitate the deployment of the anchor from a straight configuration to a deployed configuration without tearing and / or without unduly restricting the deployment. For example, the material of the skirt may be suitably flexible so as to not overcome or unduly restrict the spring bias of the wire frame into a curved configuration. Further, the skirt material may be suitable flexible to conform to the epicardium once deployed. Additionally, the skirt material may be suitably durable to be structurally sound over a period of time after deployment subject to the dynamic movement of the beating heart.[000137] The wire frame 222 can have a wire first end with a distal eyelet 224 and a wire second end with a proximal eyelet 226. The distal eyelet 224 and the proximal eyelet 226 can be the terminal ends of the wire frame 222. The distal eyelet 224 and the proximal eyelet 226 can be anti-traumatic ends of the wire frame 222. As shown in Fig. 21 A, the distal eyelet 224 can be at the end of the wire frame. This can allow for the end of the wire frame to be anti-traumatic to abutting tissue. For example, the distal eyelet 224 can prevent the end of the wire frame from damaging tissue that the end of the wire frame may come into contact with. As further shown in Fig. 21 , the proximal eyelet 226 can be adjacent to and spaced from the end of the wire frame 222. This can allow for the end of the wire frame to be located within an area surrounded by the wire frame 222. Inother words, this can allow for the end of the wire frame to be internal to or be protected by the circumference of the wire frame 222. Additionally, the proximal eyelet 226 can prevent an end point of the wire frame from damaging tissue that the end point of the wire frame may come into contact with. As shown in FIG. 21 B, the wire frame 222 can have a proximal leg or t-bar proximal leg 228 at a proximal portion of the wire frame 222 in the straight configuration. The t-bar 290 can function similarly to the t-bar proximal leg 228 of the pericardial anchor 220. The t-bar 290 can be positioned against the puncture in the myocardium in the epicardial cavity. This positioning can not only seal the puncture, but can also assist in preventing the pericardial anchor from non-planar deployment and unfurling under the t-bar itself. For example, the positioning of the t-bar 290 can create a surface for the pericardial anchor to deploy on to. The t-bar 290 covered with a film can be integrated or separated with the transmyocardial pledget 240. In some embodiments, the t-bar 290 may be deployed or positioned to seal the puncture prior to or after the coiling of the skirt 230.[000138] The proximal leg 228 can be positioned distal of the proximal eyelet 226 of the wire frame 222 in the straight configuration. The proximal leg 228 can be a straight portion of the wire frame 222 that remains straight in both the straight configuration and the curved configuration, wherein in this embodiment is in a shape of a ring.[000139] The proximal leg 228 can be reinforced, such as to resist a tensile or bearing force, compared the remainder of the wire frame 222. In accordance with an embodiment, the proximal leg 228 can include two portions of the same wire that is doubled up, such that they are parallel to each other and can be touching one another, and can be coupled together. In some embodiments, the proximal leg 228 can have a material property that is stiffer than a remainder of the wire. This advantageously allows the proximal leg 228 to resist bending and remain straight during deployment of the pericardial anchor 220, for example while bearing against a distal end of a delivery catheter, while the remainder of the wire frame 222 can be deployed to form a curved configuration. Additionally, this advantageously allows for enhanced actuation and enhanced tactile feedback witnessed by the operator of the pericardial anchoring system 200 when the proximal leg 228 is deployed and retracted. In one embodiment, the proximal leg 228 is configured to remain straight and to seat the pericardial anchor 220against the delivery catheter distal end 502 and the puncture in the epicardium to retain the pericardial anchor 220 in the pericardial space and to prevent the passage of the proximal leg 228 through the epicardium or back into the delivery catheter distal end 502 once in the pericardial space. The proximal leg 228 is operable to prevent the pericardial anchor 220 from being pulled proximally through the puncture in the epicardium.[000140] In accordance with an embodiment, the proximal leg 228 is configured to maintain a straight configuration such that in combination with a curved bias of the remaining portion of the wire frame 222, presents an urging engagement with the delivery catheter so as to assist in deployment of the pericardial anchor 220. In accordance with another embodiment, the proximal leg 228 is configured to maintain a straight configuration such that in combination with the curved bias of the remaining portion of the wire frame 222, presents a profile operable to prevent the anchor from passing through the puncture in the epicardium once deployed.[000141 ] The skirt 230 can be coupled to the wire frame 222 along an edge defining a length. The wire frame 222 can be positioned on one end or edge of the skirt 230. In one embodiment, a tether or pericardial anchor suture 280 is coupled to an opposite edge of the skirt 230. In accordance with another embodiment, a plurality of anchor apertures 232 are positioned along an edge of the skirt 230 opposite the wire frame 222. The tether or pericardial anchor suture 280 is alternately weaved through the plurality of anchor apertures 232 and slidably received therethrough. The plurality of anchor apertures 232 may be arranged along the edge of the skirt 230 in a pattern or in a random arrangement. For example, the plurality of anchor apertures 232 may be arranged in a straight arrangement, a zig-zag arrangement, etc. A first end of the pericardial anchor suture 280 is configured to be fixedly coupled to a first end of the skirt 230 at a suture attachment 234. The suture attachment 234 can be a reinforced portion of the skirt 230 wherein the reinforced portion is reinforced with additional material, or a secondary material added to facilitate and strengthen the coupling, in accordance with an embodiment. In another embodiment, the reinforced portion may have a different material property, such as, but not limited to, pressure and / or heat densification, such as with a porous material. The suture attachment 234 can be at a distal end or portion of the skirt 230. This can advantageously improve deployment ofthe pericardial anchor 220 and in retaining tension of the pericardial anchor suture 280. In accordance with an embodiment the suture attachment 234 at a distal end or portion of the skirt 230 in cooperative engagement with the anchor apertures 232 in the skirt 230 results in a predetermined amount of force distribution along the skirt 230 as compared with a more concentrated load at the attachment point located at a more proximal location on the skirt 230.[000142] The entire wire frame 222 may be coupled to the skirt 230. In an embodiment, the skirt 230 covers the entire wire frame 222, such as, for example, by being within a fold or hem of the film or embedded within layers of the film, which can improve stability of the pericardial anchor 220 in the event of a fracture or damage of the wire frame 222. The skirt 230 covering the wire frame 222 can additionally prevent the pericardial anchor suture 280 from being misrouted or becoming entangled with the wire frame 222, in particular during transition between the predeployed configuration (such as the elongate configuration) to the deployed configuration (such as a curved configuration) of the pericardial anchor 220.[000143] In other embodiments, instead of weaving the pericardial anchor suture 280 through a plurality of anchor apertures 232, the pericardial anchor suture 280 can be incorporated into the skirt 230 in other ways, such as by being integrated into the skirt 230 itself or by being fixedly attached or slidingly received within a portion of the skirt 230. In some examples, the skirt 230 can include a tunnel or channel that slidingly receives the pericardial anchor suture 280.[000144] In other embodiments, instead of a wire frame 222, a biasing element can be integrated or incorporated into the skirt 230. The biasing element is operable to bias the skirt 230 into a curved configuration. In accordance with an embodiment, the biasing element can be a densified, embossed, or treated portion of the skirt 230 that is operable to have a bias so as to transform the pericardial anchor 220 from a predeployed configuration to a deployed configuration, such as from an elongate configuration to a curved configuration.[000145] The pericardial anchor 220 can be maintained in the straightened configuration against the bias of the wire frame 222 in the predeployed configuration byapplying tension to a suture distal end 315 of the pericardial anchor suture 280 and / or a suture proximal end 317 of the pericardial anchor suture 280 that extends through the skirt 230, as shown in FIG. 18. The pericardial anchor suture 280 can be operable to be tensioned so as to collapse the skirt 230 into a curve, disk, or annular shape when the wire frame 222 is in a deployed configuration. The pericardial anchor suture 280 may be operable to collapse 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.[000146] In some configurations, the wire frame 222 can be biased to form a helix when in the curved configuration in the deployed configuration. This bias towards a helix can advantageously prevent the wire frame 222 from becoming entangled with itself, other components of the anchor system or the area of implantation. The helix configuration can assist in allowing the pericardial anchor 220 to transform to a coiled configuration. In some configurations, the wire frame 222 has a bias to conform the pericardial anchor 220 so as to define a substantially planar disk when in the deployed configuration.[000147] In other embodiments, instead of a coiled configuration as shown in FIGs. 19 and 20, the pericardial anchor 220 can transition from a predeployed configuration (such as an elongate configuration) suitable for pre-deployed configuration such as within a catheter to a deployed configuration (such as a T-shaped, ring, coiled, curved, compressed, bunched, or wadded configuration) in a variety of ways. For example, the pericardial anchor 220 can begin to curve or coil beginning or initiating from a free end of the pericardial anchor 220 to form a deployed shape, such a disc-like shape. The free end can be a distal end of the pericardial anchor 220, which can be the distal terminal end of both the pericardial anchor 220 and the pericardial anchoring system 200. The coiling that can occur can be partial to form a partial disc shape, complete to form a full disc shape, overlapping to form a full disc shape. The disc-like shape may have a low profile so as to not significantly abut the visceral pericardium or otherwise significantly interfere with the pericardium. The size of the disc-like shape may be configured operable to prevent the pericardial anchor 220 from pulling through the heart wall through the puncture or channel in the myocardium from the delivery subsystem 400 orthe pericardial anchor suture 280. The size of the disc-like shape may be configured operable to atraumatically distribute the forces that are on the pericardial anchor 220 and surrounding tissue onto which is in abutment caused by the tension on the remaining portions of the pericardial anchoring system 200. In accordance with other embodiments, the shape of the anchor may define other shapes, such as, but not limited to, square, cross, and diamond shapes. The wire frame 222 of the pericardial anchor 220 is operable to straighten out and return to a low profile, high surface area shape which is advantageous for delivery and deployment of the pericardial anchor 220. The pericardial anchor 220 defining a surface area within the disc-like shape also promotes tissue ingrowth and / or distributes loading on the pericardial anchoring system 200 over a larger area of the heart surface.[000148] In some embodiments, the pericardial anchor 220 can be bunched or wadded to achieve a deployed configuration. For example, the pericardial anchor 220 in the elongate configuration can be folded, compressed, bunched, curled, or wadded to form a deployed configuration.TRANSMYOCARDIAL PLEDGET[000149] The pericardial anchoring system 200 can include a transmyocardial pledget as disclosed in International Application No. PCT / US2020 / 032054 or International Application No. PCT / US2020 / 032168 (the entireties of which are incorporated by reference herein) and the various embodiments of transmyocardial pledgets disclosed therein. The transmyocardial pledget 240 may be tubular, spherical, rectangular, or the like. The transmyocardial pledget 240 may be used to extend the surface area of the pledget suture 300.[000150] FIG. 22 illustrates an example embodiment of the transmyocardial pledget 240. The transmyocardial pledget 240 may include the pericardial anchor suture 280, a pledget suture 300, a compressing element 310, and a plurality of pledget apertures 320 along the transmyocardial pledget 240. In some embodiments, the pericardial anchor suture 280 may be tensioned to collapse the pericardial anchor 220. In some embodiments, the pledget suture 300 may be tensioned to cinch the transmyocardial pledget 240. As explained below, the compressing element 310 may be integrated with the pledget suture 300 and can be used to transform the transmyocardial pledget 240from a pre-cinched configuration to a cinched configuration. In some embodiments, the compressing element 310 may be integrated with a first end 370 of the pledget suture 300. As shown in FIG. 22, the transmyocardial pledget 240 may have a pre-cinched configuration. The transmyocardial pledget 240 may be in a pre-cinched configuration before tension is applied to the pledget suture 300. In some embodiments, the transmyocardial pledget 240 may form a cinched configuration when tension is applied to a second end 380 of the pledget suture 300, as further explained below.[000151 ] As shown in FIG. 22, in some embodiments, the pledget suture 300 can extend through the transmyocardial pledget 240. The transmyocardial pledget 240 can include a plurality of pledget apertures 320. The pledget suture 300 may be woven through the plurality of pledget apertures 320. The plurality of pledget apertures 320 may be of various sizes. A distance between each of the plurality of pledget apertures 320 may vary. In some embodiments, a distance between at least two of the plurality of pledget apertures 320 located at a proximal end 350 of the transmyocardial pledget 240 may be less than the distance between at least two of the plurality of pledget apertures 320 located in a middle portion 245 of the transmyocardial pledget 240. In some embodiments, the plurality of pledget apertures 320 may include a first set of apertures 330 and a second set of apertures 340. For example, the first set of apertures 330 include at least one needle punched hole and the second set of apertures may include at least one biopsy hole. The first set of apertures 330 and the second set of apertures 340 may be located at a distal end 360 of the transmyocardial pledget 240. The first set of apertures 330 and the second set of apertures 340 may receive the pledget suture 300 to be woven through the plurality of pledget apertures 320. In some embodiments, the first set of apertures 330 and the second set of apertures 340 may receive the first end 370 of the pledget suture 300 and the second en 380 of the pledget suture 300, respectively. In some embodiments, the first set of apertures 330 may be sufficiently small or have a sufficiently small dimension so as to prevent the compressing element 310 that is integrated with the first end 370 of the pledget suture 300 from entering and / or passing through the first set of apertures 330. For example, the first set of apertures 330 may be a slit or small hole with a dimension that is smaller than the compressing element 310.[000152] In some embodiments, the distance between the first set of apertures 330 and the second set of apertures 340 may be between approximately 1 mm - 5mm. In another embodiment, the distance between the first set of apertures 330 and the second set of apertures 340 may be approximately 3mm. The distance between the first set of apertures 330 and the second set of apertures 340 may be sufficiently long enough to help to ensure the compressing element 310 that is integrated with the first end 370 of the pledget suture 300 may not interact with the suture lock 270. In some embodiments, the first set of apertures 330 may allow for the compressing element 310 to remain near the distal end 360 of the transmyocardial pledget 240 in a pre-cinched configuration of the transmyocardial pledget 240 and a cinched configuration of the transmyocardial pledget 240. In other words, the first set of apertures 330 has a dimension so as to prevent the compressing element 310 from entering and / or passing through the first set of apertures 330 before, during and after the formation of the cinched configuration of the transmyocardial pledget 240.[000153] FIG. 23 is a detailed view of the first set of apertures 330 of the transmyocardial pledget 240 in a pre-cinched configuration as illustrated in FIG. 22. As shown in FIG. 23, the first set of apertures 330 defines a dimension sufficiently small enough to prevent the compressing element 310 from entering and / or passing through the first set of apertures 330. As further shown in FIG. 23, and explained above, the compressing element 310 is located between the first set of apertures 330 and the anchor socket 260. In some embodiments, the compressing element 310 is operable to engage and apply pressure to the surface of the transmyocardial pledget 240 so as to cinch or collapse the transmyocardial pledget 240 while remaining between the first set of apertures 330 and the anchor socket 260 as the transmyocardial pledget 240 cinches or collapses. The compression of the transmyocardial pledget 240 in response to pressure applied to the transmyocardial pledget 240 by the compressing element 310 by tensioning the pledget suture 300 will be further described below.[000154] FIG. 24 is a detailed view of the first set of apertures 330 of the transmyocardial pledget 240 of FIG. 22 in a cinched configuration. As shown in FIG. 24, the first set of apertures 330 is sufficiently small so as to prevent the compressing element 310 from entering the first set of apertures 330 as the compressing element310 applies pressure to the transmyocardial pledget 240 so as to cinch the transmyocardial pledget 240 by tension applied to the pledget suture 300. As further shown in FIG. 24, the compressing element 310 applies pressure to the surface of the transmyocardial pledget 240, which is operable to compress, fold, scrunch, bunch, or the like, the transmyocardial pledget 240. For example, in one embodiment, the compressing element 310 is operable to apply pressure to the transmyocardial pledget 240 and thus affect the effective length or profile shape of the transmyocardial pledget 240 to decrease by way of compressing, folding, scrunching, or otherwise the transmyocardial pledget 240, which may cause the distance between the pericardial anchor 220 and the anchor socket 260 to decrease. In some embodiments, the pressure applied to the transmyocardial pledget 240 by the compressing element will decrease the distance between the pericardial anchor 220 and the anchor socket 260. As further shown in FIG. 24, and explained above, the compressing element 310 is in between the first set of apertures 330 and the transmyocardial pledget 240, as the transmyocardial pledget 240 transforms from an elongated configuration into the cinched configuration.[000155] FIG. 25A-25B illustrates an example embodiment of the suture path of the pledget suture 300 through the transmyocardial pledget 240. As shown in FIG. 25A- 25B, the pledget suture 300 can be woven through the plurality of pledget apertures 320, as shown in FIG. 22, defined by the transmyocardial pledget 240. In some embodiments, the first end 370 of the pledget suture 300 is woven through the plurality of pledget apertures 320 from the distal end 360 of the transmyocardial pledget 240 to the proximal end 350 of the transmyocardial pledget 240. The pledget suture 300 is woven back through the same or different plurality of pledget apertures 320 from the proximal end 350 of the transmyocardial pledget 240 to the distal end 360 of the transmyocardial pledget 240. This provides that the first end 370 of the pledget suture 300 and the second end 380 of the pledget suture 300 to extend from the distal end 360 of the transmyocardial pledget 240. In some embodiments, the pledget suture 300 may be woven back through the same plurality of pledget apertures 320 from the proximal end 250 of the transmyocardial pledget 240 to the distal end 360 of the transmyocardial pledget 240 as the plurality of pledget apertures 320 that the pledgetsuture 300 was woven through from the distal end 360 of the transmyocardial pledget 240 to the proximal end 350 of the transmyocardial pledget. This may allow the transmyocardial pledget 240 to accordion or cinch uniformly. In some embodiments, the pledget suture 300 may be woven back through different plurality of pledget apertures 320 from the proximal end 250 of the transmyocardial pledget 240 to the distal end 360 of the transmyocardial pledget 240 than the plurality of pledget apertures 320 that the pledget suture 300 was woven through from the distal end 360 of the transmyocardial pledget 240 to the proximal end 350 of the transmyocardial pledget. This may allow the transmyocardial pledget 240 to bunch or cinch non-uniform ly.[000156] In some embodiments, the distal end 360 of the transmyocardial pledget 240 may be connected to the anchor socket 260. In some embodiments, the proximal end 350 of the transmyocardial pledget 240 may be connected to the pericardial anchor 220. For example, the pledget suture 300 may enter one of the plurality of the pledget apertures 320 and exit the transmyocardial pledget 240 through one of the following plurality of pledget apertures 320. In some embodiments, the pledget suture 300 may be weaved through the plurality of pledget apertures 320 from the proximal end 350 of the transmyocardial pledget 240 to the distal end 360 of the transmyocardial pledget 240 after the pledget suture 300 is weaved through the plurality of pledget apertures 320 from the distal end 360 of the transmyocardial pledget 240 to the proximal end 350 of the transmyocardial pledget 240. In some embodiments, pledget suture 300 may be routed through the same plurality of pledget apertures 320 in the distal to proximal direction and the proximal to distal direction.[000157] One of the more proximal or the most proximal apertures 355 of the plurality of pledget apertures 320 may be the aperture at which the pledget suture changes direction to weave through the plurality of pledget apertures 320 in the opposite direction than it was previous weaved. The more proximal or the most proximal aperture 355 of the plurality of pledget apertures 320 may be one of the plurality of pledget apertures 320 that is furthest from the anchor socket 260. In other words, the more proximal or the most proximal aperture 355 of the plurality of pledget apertures 320 may be located on the proximal end 350 of transmyocardial pledget 240. In otherwords, the more proximal or the most proximal aperture 355 of the plurality of pledget apertures 320 may be closest to the pericardial anchor 220.[000158] As further shown in FIG. 25A-25B, the plurality of pledget apertures 320 located at a proximal portion of the transmyocardial pledget 240 may have a shorter distance between each of the plurality of pledget apertures 320 than the plurality of pledget apertures 320 located at the middle portion of the transmyocardial pledget 240. The shorter distance between each of the plurality of pledget apertures at the proximal portion of the transmyocardial pledget 240 may allow the pledget to bunch inside of the endocardium to substantially seal the tissue when the transmyocardial pledget 240 is transformed from the pre-cinched configuration to the cinched configuration. The greater distance, comparatively, between each of the plurality of pledget apertures 320 located at the middle portion of the transmyocardial pledget 240 may allow the transmyocardial pledget 240 to fold to lay substantially flush with the endocardium when the transmyocardial pledget 240 is transformed from the pre-cinched configuration to the cinched configuration. It is appreciated that the distance between pledget apertures 320 affects a folding or scrunching configuration of the transmyocardial pledget 240 suitable for a particular purpose, and that it may be varied along a length of the transmyocardial pledget 240. It is also appreciated that the choice of pledget aperture 320 traversed by the pledget suture 300 will affect a folding or scrunching configuration of the transmyocardial pledget 240 and / or the variation of tension that a user will sense, suitable for a particular purpose, and that it may be varied along a length of the transmyocardial pledget 240.[000159] In some embodiments, when the pledget suture 300 is weaved through the plurality of pledget apertures 320 in both directions, a first end 370 of the pledget suture 300 and a second end 380 of the pledget suture 300 may exit the transmyocardial pledget 240 at the distal end 360 of the transmyocardial pledget 240. The first end of the pledget suture 300 can include, define and / or couple to the compressing element 310. The compressing element 310 remains between the first set of apertures 330 and the anchor socket 260. The second end 380 of the pledget suture 300 can be a tail 385, as shown in FIG. 22, that extends through the anchor socket 260 for which tension may be applied operable to cinch the transmyocardial pledget 240. Insome embodiments, the compressing element 310 does not engage with the suture lock. In some embodiments, a second end 380of the pledget suture 300 extends through the anchor socket 260.[000160] The pledget suture 300 may be routed through the transmyocardial pledget 240 prior to loading the transmyocardial pledget 240 on the delivery system , as discussed above. The plurality of pledget apertures 320 may be arranged in a random arrangement or a patterned arrangement. For example, the pledget apertures 320 may be arranged in, such as, but not limited to, a co-linear arrangement, zig-zag arrangement, among others, suitable for a particular purpose of, for example, to affect a particular dimensional change to the transmyocardial pledget 240 when in the compressed configuration. The pledget suture 300 can be made of any suitable biocompatible material, such as, but not limited to fluropolymer fibers.[000161 ] FIG. 26 illustrates an example embodiment of the transmyocardial pledget 240 in a cinched configuration. The transmyocardial pledget 240 may transform into the cinched configuration from the pre-cinched configuration of the transmyocardial pledget 240 by the application of tension on the pledget suture 300 and the pericardial anchor 220. In some embodiments, the pledget suture 300 can allow the transmyocardial pledget 240 to convert from a straighter configuration or a pre-cinched configuration, such as shown in FIG. 22, to a cinched configuration, such as shown in FIG. 26. For example, tension applied to the second end 380 of the pledget suture 300 can allow the compressing element 310 located at the first end 370 of the pledget suture 300 to apply pressure to the surface of the transmyocardial pledget 240 and cinch, compress or fold down the transmyocardial pledget 240 in an accordion-like manner. For example, the compressing element 310 applying pressure to the transmyocardial pledget 240 decreased the effective length or the profile shape of the transmyocardial pledget 240 by compressing, folding, scrunching, or otherwise compressing the transmyocardial pledget 240. This decreases the distance between the pericardial anchor 220 and the anchor socket 260. The transmyocardial pledget 240 may incorporate pleats so as to facilitate folding during the compression of the transmyocardial pledget 240.[000162] The transmyocardial pledget 240 may transition from a straighter precinched configuration to a curved or cinched configuration before or after the fulldeployment of the pericardial anchor 220. For example, the pericardial anchor 220 may curl or collapse adjacent to and / or against the epicardium by the engagement of tension on the pericardial anchor suture 280 before the engagement of tension on the pledget suture 300 is used to transform the transmyocardial pledget 240 into a curved or cinched configuration. Similarly, in another embodiment, the t-bar may be deployed adjacent to and / or against the epicardium before the engagement of tension on the pledget suture 300 is used to transform the transmyocardial pledget 240 to a compressed configuration prior to the curling or collapsing of the pericardial anchor 220 adjacent to and / or against the epicardium by the engagement of tension on the pericardial anchor suture 280. In this way, the pledget suture 300 and the pericardial anchor suture 280 are independently operable. In other words, applying tension to the pledget suture 300 does not affect the configuration of the pericardial anchor 220 and applying tension to the pericardial anchor suture 280 does not affect the configuration of the transmyocardial pledget 240.[000163] The transmyocardial pledget 240 can include a film comprising one or more layers. The film can be a fluoropolymer, which can have tissue ingrowth properties. The film of the transmyocardial pledget 240 can have a tubular structure. The transmyocardial pledget 240 can include a plurality of pledget apertures 320 positioned along the length of the transmyocardial pledget 240. The pledget suture 300 can be woven through or integrated in the film of the transmyocardial pledget 240, such as, but not limited to, between layers of the film that forms a composite layup. As shown in FIGs. 18 and 19, the pledget suture 300 can be woven through a plurality of pledget apertures 320 through the film of the transmyocardial pledget 240. The pledget suture 300 can allow the transmyocardial pledget 240 to convert from a straighter configuration, such as shown in FIG. 18, to a curved configuration, such as shown in FIG. 20. For example, tension or retraction of the pledget suture 300 can compress or fold down the material of the transmyocardial pledget 240 in an accordion-like manner. The transmyocardial pledget 240 may incorporate pleats so as to facilitate folding during the deployment of the transmyocardial pledget 240. The transmyocardial pledget 240 may transition from a straighter configuration to a curved configuration before or after the deployment of the pericardial anchor.[000164] The transmyocardial pledget 240 may further include the compressing element 310, which may be located at the first end 370 of the pledget suture 300. The compressing element 310 may be used to assist in cinching the transmyocardial pledget 240 or transforming the transmyocardial pledget 240 from a pre-cinched configuration to a cinched configuration. The compressing element 310 may be a separate element coupled to the first end 370 of the pledget suture 300 or an integral element defined by the first end 370 of the pledget suture 300. In some embodiments, for example, the compressing element 310 may include a knot. In other embodiments, for example, the compressing element 310 is a ring to which the first end 370 of the pledget suture 300 is coupled. In some embodiments, the suture second end 380 is threaded through and slidingly received within the compressing element 310 so as to allow a sliding engagement therebetween. Tension applied to the second end 380 of the pledget suture 300 is operable to translate the compressing element 310 along the second end 380 of the pledget suture 300 so as to apply pressure to a surface of the transmyocardial pledget 240 by the urging engagement of the compressing element 310 against the transmyocardial pledget 240. This causes the transmyocardial pledget 240 to cinch, fold, wad, and / or decrease in effective length and expand in girth, i.e., transverse to the longitudinal axis of the transmyocardial pledget 240, so as to block, seal or fill the space or channel in the myocardium in which it traverses.[000165] In other embodiments, the suture second end 380 is not threaded through the compressing element 310. Tension applied to the second end 380 of the pledget suture 300 is operable to translate the compressing element 310 to the first set of apertures 330 so as to apply pressure to a surface of the transmyocardial pledget 240 by the urging engagement of the compressing element 310 against the transmyocardial pledget 240. This causes the transmyocardial pledget 240 to cinch, fold, wad, and / or decrease in effective length and expand in girth, i.e., transverse to the longitudinal axis of the transmyocardial pledget 240, so as to block, seal or fill the space or channel in the myocardium in which it traverses .[000166] The compressing element 310 may allow the transmyocardial pledget 240 to cinch from the distal end 360 of the transmyocardial pledget 240 to the proximal end 350 of the transmyocardial pledget 240. The pressure applied to the compressingelement 310 may collapse the transmyocardial pledget 240. For example, the compressing element 310 may translate to the first set of apertures 330, which may allow the compressing element 310 to apply pressure to the surface of the transmyocardial pledget 240. In some embodiments, tension may be applied to the second end 380 of the pledget suture 300 in a second direction 390. This affects the compressing element 310 to translate along the pledget suture 300 and apply pressure to the surface of the transmyocardial pledget 240, which is operable to transition the transmyocardial pledget 240 into the cinched configuration. The second direction 390 may be in a direction away from the pericardial anchor 220 and / or t-bar 290.[000167] In some embodiments, translation of the compressing element 310 may lock the transmyocardial pledget 240 in a collapsed or cinched configuration. The transmyocardial pledget 240 may remain locked in a cinched configuration due, by way of example, but not limited to, by resistance of movement or friction between the pledget suture 300 and the plurality of pledget apertures 320. In some embodiments, a predetermined resistance between the pledget suture 300 and the plurality of pledget apertures 320 may allow the transmyocardial pledget 240 to remain in the cinched configuration, as shown in FIG. 24. In some embodiments, a second predetermined resistance between the compressing element 310 and the first end 370 of the pledget suture 300 may also allow the transmyocardial pledget 240 to remain in the cinched configuration, as shown in FIG. 24. In some embodiments, a combination of the predetermined resistance and the second predetermined resistance can allow the transmyocardial pledget 240 to remain in the cinched configuration, as shown in FIG. 24. In some embodiments, the compressing element 310 may translate to a new position or return to its original position, which may not affect the configuration of the transmyocardial pledget 240. This may allow for the pledget suture to be untensioned or for minimal tension to be applied to the pledget suture 300 when the transmyocardial pledget 240 is in the cinched configuration. In other words, slack of the pledget suture 300 may be provided after the transmyocardial pledget 240 reaches a collapsed configuration while maintaining the collapsed configuration. Subsequent tension applied to the pledget suture 300 may be independent of or have minimal effect on the configuration of the transmyocardial pledget 240. This may allow for the pericardialanchor suture 280 and the pledget suture 300 to be independently operable of each other.[000168] In other embodiments, the pledget suture 300 may remain under a predetermined resistance when the transmyocardial pledget 240 is in a collapsed configuration. In some embodiments, a predetermined tension may be applied to the second end 380 of the pledget suture 300, which may cinch the transmyocardial pledget 240. This may create the predetermined resistance between the pledget suture 300 and the transmyocardial pledget 240 that allow the transmyocardial pledget 240 to remain in the cinched configuration. In some embodiments, the predetermined tension may be between approximately 0.5N-3N. In some embodiments, the predetermined tension may be approximately between 1 N-2N.[000169] In some embodiments, the translation of the compressing element 310 is operable to apply pressure to the surface of the transmyocardial pledget 240, which assists in holding or maintaining the transmyocardial pledget 240 in a cinched or collapsed configuration. This allows the transmyocardial pledget 240 to have an adjustable configuration. In this manner, the transmyocardial pledget 240 may not be locked in a single configuration, but adjustable throughout the mitral valve repair. For example, the configuration of the transmyocardial pledget 240 may be adjusted at the time of, before, or after the locking of the leaflet anchor suture, as explained below.[000170] FIG. 27A illustrates an example embodiment of the pledget suture 300. As shown in FIG. 27A, the pledget suture 300 defines the compressing element 310 as a unitary component to the pledget suture 300 in the form of a defined loop secured by a knot. The compressing element 310 is located at the first end of the pledget suture 300. The compressing element 310 may be a knot, or a non-slip knot, or a non-slip loop knot, which may be used to apply pressure to the surface of the transmyocardial pledget 240 to transform the transmyocardial pledget 240 from a pre-cinched configuration to a cinched configuration. The compressing element 310 may be at a fixed length of the first end 370of the pledget suture 300. The second end 380 of the pledget suture 300 may remain extended or elongated to allow for tension to be applied to the second end 380 of the pledget suture 300. In some embodiments, tension may be applied to the second end 380 of the pledget suture 300, which is operable to cause the compressingelement 310 to translate along the pledget suture 300 and apply pressure to the surface of the transmyocardial pledget 240. In some embodiments, wherein the second end 380 of the pledget suture 300 is slidingly received by the compressing element 310, the compressing element 310 may not tighten about the second end 380 of the pledget suture 300, change the length of the first end 370 of the pledget suture 300, and / or change in diameter when formed as a loop when tension is applied to the second end 380 of the pledget suture 300. In some embodiments, tension applied to the second end 380 of the pledget suture 300 may be applied in a second direction 405. For example, the second direction 405 may be a direction away from the pericardial anchor. This may cause the compressing element 310 to translate along the pledget suture 300 in a first direction 410 opposite the second direction 405. In some embodiments, the compressing element 310 translates along the pledget suture 300 in the first direction 410 when tension is applied to the second end 380 of the pledget suture 300 in the second direction 405. The first direction 410 may be a direction towards the pericardial anchor.[000171 ] FIG. 27B illustrates an example embodiment of the compressing element 310. As shown in FIG. 27B, the compressing element 310 may be a non-slip loop knot. The compressing element 310 may be at a fixed length of the first end 370 of the pledget suture 300. In some embodiments, the compressing element 310 may include a knot 312 and a loop 314. In this manner, the loop 314 of the compressing element 310 may be locked or fixed, which may allow the first end 370 of the pledget suture 300 integrated with the compressing element 310 to be substantially free moving, untensioned, or unsecured along the second end 380 of the pledget suture 300 when slidingly receive thereby. In some embodiments, the knot 312 may be a washer, o-ring, or the like. In some embodiments, the knot 312 may be sufficiently large to prevent the compressing element 310 from entering the first aperture of the first set of apertures 330.[000172] FIG. 28 illustrates an example embodiment of the pericardial anchor system 200 laid in a flat configuration. The pericardial anchor system 200 may include the transmyocardial pledget 240 and the pericardial anchor 220. In some embodiments, the pericardial anchor 220 and the transmyocardial pledget 240 may be perpendicularto each other. The proximal end of the transmyocardial pledget 240 may connect to the proximal end of the pericardial anchor 220 in a perpendicular arrangement. In some embodiments, the pericardial anchor system 200 may further include a pericardial anchor suture 280 and a pledget suture 300. The pledget suture 300 may be woven through a plurality of pledget apertures 320 located on the transmyocardial pledget 240. The plurality of pledget apertures 320 may be arranged in a random arrangement, a straight arrangement, patterned arrangement or the like. In some embodiments, the plurality of pledget apertures may be evenly spaced between each other. In other embodiments, the plurality of pledget apertures 320 may each have different spacing between each other. In some embodiments, at least some of the plurality of pledget apertures 320 located at a proximal portion of the transmyocardial pledget 240 may have a smaller distance between each other compared to at least some of the plurality of pledget apertures 320 located at a middle portion of the transmyocardial pledget 240. In some embodiments, at least some of the plurality of pledget apertures located at a distal portion of the transmyocardial pledget 240 may have a smaller distance between each other compared to at least some of the plurality of pledget apertures 320 located at the middle portion of the pledget. 240. For example, a first distance between a first aperture of the plurality of pledget apertures and a second aperture of the plurality of apertures may be smaller than a second distance between the second aperture and a third aperture of the plurality of apertures. In some embodiments, the arrangement and / or placement of the plurality of pledget apertures 320 may determine how the transmyocardial pledget 240 transforms from the pre-cinched configuration to the cinched configuration. For example, the plurality of pledget apertures located at the proximal portion of the transmyocardial pledget 240 may allow the transmyocardial pledget 240 to bunch in a compact manner. In another example, the plurality of pledget apertures located at the middle portion of the transmyocardial pledget 240 may allow the transmyocardial pledget 240 to fold or fold uniformly.[000173] The pledget suture 300 may be woven through some or each of the plurality of pledget apertures 320. In some embodiments, the pledget suture 300 may be woven through some or each of the plurality of pledget apertures 320 more than once. For example, the pledget suture 300 may be woven through some or each of theplurality of pledget apertures 320 from the distal end 360 of the transmyocardial pledget 240 to the proximal end 350 of the transmyocardial pledget 240. Once the pledget suture 300 is woven through one of the pledget apertures that is near or nearest the proximal end 350 of the transmyocardial pledget 240, the pledget suture 300 may reverse directions and weave through some or each of the plurality of pledget apertures 320 from the proximal end 350 of the transmyocardial pledget 240 to the distal end 360 of the transmyocardial pledget 240. In accordance with an embodiment, wherein the pledget suture 300 is woven sequentially through each of the plurality of pledget apertures 320 from the distal end 360 of the transmyocardial pledget 240 to the proximal end 350 of the transmyocardial pledget 240 and back through the same respective plurality of pledget apertures 320 from the proximal end 350 of the transmyocardial pledget 240 to the distal end 360 of the transmyocardial pledget 240 will cause the transmyocardial pledget 240 to compress in an accordion-like manner, which may provide a predetermined profile to affect a sealing engagement with the endocardium or a channel in the myocardium. In accordance with another embodiment, wherein the pledget suture 300 is woven sequentially through each of the plurality of pledget apertures 320 from the distal end 360 of the transmyocardial pledget 240 to the proximal end 350 of the transmyocardial pledget 240 and back through different pledget apertures 320 from the proximal end 350 of the transmyocardial pledget 240 to the distal end 360 of the transmyocardial pledget 240 will cause the transmyocardial pledget 240 to compress in a more disorganized bunching manner relative to the accordion manner, which may provide a predetermined profile to affect a sealing engagement with the endocardium or a channel in the myocardium.[000174] In some embodiments, the pericardial anchor suture 280 may be woven through some, none, or at least two of the plurality of pledget apertures 320. This may allow the pericardial anchor suture 280 connected to the pericardial anchor 220 to be woven through a plurality of anchor apertures 232 located on the pericardial anchor. For example, the pericardial anchor suture 280 may be woven through a proximal pledget aperture 320 of the plurality of pledget apertures that is located on the transmyocardial pledget 240 that is closest in distance to the pericardial anchor. The pericardial anchor suture 280 may then be woven through some or all of the plurality of anchor apertures232 located on the pericardial anchor. This may allow tension to be applied to the pericardial anchor suture 280, as described above, for the pericardial anchor 220 to deploy, which may not affect the configuration of the transmyocardial pledget 240. In this manner, the pericardial anchor suture 280 and the pledget suture 300 may be independently operable. In some embodiments, the pericardial anchor suture 280 may weave through a second set of plurality of apertures, not shown, located on the transmyocardial pledget 240. In some embodiments, the pericardial anchor 220 may deploy to form a disc shape, for example. In some embodiments, the pericardial anchor suture 280 may extend past the distal end 360 of the transmyocardial pledget 240, which can allow for the pericardial anchor suture 280 to be accessible for tensioning. [000175] In some embodiments, the pericardial anchor suture 280 may be tensioned prior to the pledget suture 300 being tensioned. For example, the pericardial anchor 220 may deploy (e.g., form a disc shape) prior to the transmyocardial pledget 240 transforming from a pre-cinched configuration to the cinched configuration. In other embodiments, the pledget suture 300 may be tensioned prior to the pericardial anchor suture 280 being tensioned. For example, the pledget suture 300 may transform from the pre-cinched configuration to the cinched configuration prior to the pericardial anchor deployment. In other embodiments, the pericardial anchor suture 280 and the pledget suture 300 may be tensioned simultaneously. For example, the transmyocardial pledget 240 may transform from the pre-cinched configuration to the cinched configuration at the same or similar time at which the pericardial anchor 220 is deployed.[000176] FIG 29 illustrates an isometric view of an example embodiment of the transmyocardial pledget 240. As shown in FIG. 29, the pericardial anchor suture 280 can extend passed the distal end 360 of the transmyocardial pledget 240. The pericardial anchor suture 280 can be tensioned to deploy the pericardial anchor 220. The first end 370 of the pledget suture 300 and the second end 380 of the pledget suture 300 may also extend passed the distal end of the pledget. In some embodiments, the second end of the pledget suture 300 may be tensioned, which may cause the compressing element 310 located on the first end 370 of the pledget suture 300 to apply pressure to the surface of the transmyocardial pledget 240. This may cause the transmyocardial pledget 240 to collapse or transform to the cinchedconfiguration. In some embodiments, the transmyocardial pledget 240 will collapse or transform to the cinched configuration when the compressing element 310 applies pressure to the surface of the transmyocardial pledget 240. As shown in FIG. 29, the compressing element 310 may be greater in size and diameter than at least one of plurality of pledget apertures 320. For example, the compressing element 310 may be greater in size and / or diameter than the first set of apertures 330. This may prevent the compressing element 310 from entering the plurality of pledget apertures 320 and allow the transmyocardial pledget 240 to form the cinched configuration. In some embodiments, the first end 370 of the pledget suture 300 may be cut at the compressing element 310. In other embodiments, the second end 380 of the pledget suture 300 may remain an element of the pericardial anchoring system.[000177] FIG. 30 illustrates a top view of an example embodiment of the transmyocardial pledget 240. As shown in FIG. 30, the compressing element 310 integrated with the pledget suture 300 may have a diameter that is greater than the size of the first set of apertures 330. This may prevent the compressing element 310 from entering the plurality of pledget apertures 320 and allow the transmyocardial pledget 240 to form the cinched configuration.[000178] FIG. 31A-31 D illustrate an example embodiment of the compressing element 310. As shown in FIG. 31 A-31 D, the compressing element 310 may include a compression fit sleeve 420. The compression fit sleeve 420 may be silicone, oPTFE, PTFE, or the like. FIG. 31 A shows a top view of the transmyocardial pledget 240 with a compression fit sleeve 420. FIG. 31 B shows a side view of the transmyocardial pledget 240 with a compression fit sleeve 420. FIG. 31 C shows an isometric view of the transmyocardial pledget 240 with a compression fit sleeve 420. FIG. 31 D shows a zoomed in view of the compression fit sleeve 420. As shown in FIG. 31 A, the compression fit sleeve 420 may be greater in size than the plurality of pledget apertures 320. This may prevent the compression fit sleeve 420 from entering the plurality of pledget apertures 320 and allow the transmyocardial pledget 240 to form the cinched configuration. In some embodiments, the pledget suture 300 may be threaded through the compression fit sleeve 420.[000179] FIG. 32A-32D illustrate an example embodiment of the compressing element 310. As shown in FIG. 32A-32D, the compressing element 310 may include a miniature pledget 430. The miniature pledget 430 may be silicone, oPTFE, PTFE, or the like. FIG. 32A shows a top view of the transmyocardial pledget 240 with miniature pledget 430. FIG. 32B shows a side view of the pledget with a miniature pledget. FIG. 32C shows an isometric view of the transmyocardial pledget 240 with a miniature pledget 430. FIG. 32D shows a zoomed in view of the miniature pledget 430. As shown in FIG. 32A, the miniature pledget 430 may be greater in size than the plurality of pledget apertures 320. This may prevent the miniature pledget 430 from entering the plurality of pledget apertures 320 and allow the pledget to form the cinched configuration. In some embodiments, the pledget suture 300 may be threaded through the miniature pledget 430. In some embodiments, the miniature pledget 430 may extend when the miniature pledget 430 is loaded with tension.[000180] FIG. 33A-33D illustrate example embodiments of an arrangement of a plurality of miniature pledget apertures 440. The plurality of miniature pledget apertures 440 may be arranged in a random or patterned arrangement. For example, the plurality of miniature pledget apertures 440 may be arranged in a zig-zag, straight, curved, or diagonal arrangement. As shown in FIG. 33A, 33B, and 33C the plurality of miniature pledget apertures 440 may be arranged in a zig-zag formation. The plurality of miniature pledget apertures 440 may be offset from a center of the miniature pledget 430. The zig-zag arrangement of the plurality of miniature pledget apertures 440 may allow the miniature pledget 430 to collapse or cinch in a twisted manner when the pledget suture 300 is tensioned. This may provide for additional resistance between the miniature pledget 430 and the pledget suture 300 before the transmyocardial pledget 240 is fully transformed into the cinched configuration.PERICARDIAL ANCHOR SYSTEM DEPLOYMENT[000181 ] The pericardial anchor system may deploy in, for example, the repairment of the mitral leaflet valve. To deploy the pericardial anchoring system 200, in some embodiments, tension may be applied to the pericardial anchor suture 280 that may be woven through the pericardial anchor 220. This may deploy the pericardial anchor 220. For example, the pericardial anchor suture 280 may deploy into a disc shape. In someembodiments, tension may be applied to the second end 380 of the pledget suture 300. This may allow the compressing element 310 to apply pressure to the surface of the transmyocardial pledget 240 in the pre-cinched configuration. This may transform the transmyocardial pledget 240 from a pre-cinched configuration to a cinched configuration. For example, tension may be applied to the second end 380 of the pledget suture 300 in a direction opposite or away from the pericardial anchor 220. The compressing element 310 may then apply pressure to the surface of the transmyocardial pledget 240 in a direction towards the pericardial anchor 220 to transform the transmyocardial pledget 240 to the cinched configuration. The transmyocardial pledget 240 may be locked in the cinched configuration. This may be because a predetermined resistance between pledget suture 300 and the transmyocardial pledget 240 can stabilize or lock the transmyocardial pledget 240 in the cinched configuration. Once the transmyocardial pledget 240 is locked, the compressing element 310 may translate to a new position or to its original position without affecting the configuration of the transmyocardial pledget 240. This may allow the pledget suture 300 to have slack, remain untensioned, or have minimal tension applied to it. The second end 380 of the pledget suture 300 and the pericardial anchor suture 280 may then be routed through the suture lock 270 within the anchor socket 260 that may be connected to the transmyocardial pledget 240. In some embodiments, the transmyocardial pledget 240 may be transformed from the pre-cinched configuration to the cinched configuration prior to the deployment of the pericardial anchor 220.SUTURE LOCK[000182] The pericardial anchoring system 200 can further include an anchor socket 260 which can hold a suture lock 270. The pericardial anchoring system 200 can include a suture lock as disclosed in U.S. Patent No. 9,877,833. The pericardial anchoring system 200 can include a suture lock and socket as disclosed in International Application No. PCT / US2021 / 035423 or U.S. Application No. 16,711 ,321 (the entireties of which are incorporated by reference herein) and the various embodiments of suture locks or sockets disclosed therein. The pericardial anchoring system 200 can include a socket as disclosed in U.S. Application No. 16 / 710,637 (the entirety of which is incorporated by reference herein) and the various embodiments of suture locks orsockets disclosed therein. The suture lock 270 can be used to secure each of the pericardial anchor suture 280 and the leaflet anchor sutures 310A. The suture lock 270 can also be used to tension and adjust the length of each of the pericardial anchor suture 280 and the leaflet anchor sutures 310A. Once the lengths have been optimized to achieve adequate tension for the mitral chord repair, the suture lock 270 can be locked to fix the length of each of the pericardial anchor suture 280 and the leaflet anchor sutures 310A.SOCKET[000183] As used herein, the term “socket” is inclusive of and may be used interchangeably with any of the following terms: covers, receptacles, shrouds, couplers, constrainers, retaining members and the like. In accordance with an embodiment, the anchor socket 260 can have a tubular structure that can receive and at least partially cover the suture lock 270. The anchor socket 260 can include a self-expanding frame that can minimize the profile of the anchor socket 260 when in the predeployed configuration on the delivery system. The self-expanding frame can be a stent frame made of nitinol. The anchor socket 260 can have a length that exceeds the length of the suture lock 270 to ensure full coverage of the suture lock 270 by the anchor socket 260. The anchor socket 260 can be a retaining member to constrain motion of the suture lock relative to the remainder of the pericardial anchoring system 200, as well as motion of the sutures relative to the suture lock 270. The anchor socket 260 can also be called a suture lock guide, socket, or sleeve. The anchor socket 260 can reduce wear on each of the pericardial anchor suture 280 and the leaflet anchor sutures 310A which can ensure the tension in the sutures. The anchor socket 260 can couple the pericardial anchoring system 200 and the suture lock.DEPLOYED ANCHORING SYSTEM[000184] FIG. 34 is an example of the pericardial anchoring system 200 deployed and partially implanted in position in the ventricle of the heart. As shown, the pericardial anchor 220 in the ring configuration is positioned in the pericardial space. The pericardial anchor 220 can anchor the pericardial anchoring system 200 and act as a mechanical interface to anchor the pericardial anchoring system 200. The pericardialanchor 220 can also act to seal one end of the myocardial puncture. The transmyocardial pledget 240 extends from the pericardial anchor 220 with a portion extending through the heart wall 41 and a portion folded down against the endocardium layer of the heart wall 41 . The suture lock 270 positioned within the anchor socket 260 can be positioned against the folded down portion of the transmyocardial pledget 240. The suture lock 270 enclosed by the anchor socket 260 can drive the anchor socket 260 to the endocardial surface, which can also encourage sealing of the puncture on the endocardial surface by the folded down portion of the transmyocardial pledget 240. The pericardial anchor suture 280 can extend through the pericardial anchor 220, through the transmyocardial pledget 240, and into the suture lock 270. The pericardial anchor suture 280 can also act as a tension member for forming the pericardial anchor 220. The pericardial anchor suture 280 can provide a rail to connect the suture lock 270. The transmyocardial pledget 240 can protect the heart wall 41 from damage due to the pericardial anchor suture 280. The transmyocardial pledget 240 adds bulk to the pericardial anchor suture 280 which, by itself, might tend to cut or slice through the myocardium with the application of tension or loading. The transmyocardial pledget 240 prevents the migration of the pericardial anchor suture 280 within the myocardium. The transmyocardial pledget 240 can create the myocardial seal by plugging the channel or puncture through the heart wall 41 and by folding up to seal the opposite end of the puncture on the endocardial surface. For example, the transmyocardial pledget 240 may cinch or collapse, which can result in engaging the t-bar 290 with the epicardium. This can seal the channel or puncture of the epicardium during a process of deploying the pericardial anchoring system 200 across the heart wall. In another example, the transmyocardial pledget 240 may cinch or collapse, which can result in the transmyocardial pledget 240 scrunching or wadding against the endocardium during a process of deploying the pericardial anchoring system 200 across the heart wall. In some embodiments, the transmyocardial pledget 240 may be flush against the endocardium during a process of deploying the pericardial anchoring system 200 across the heart wall when in the cinched configuration. This can seal the channel or puncture of the endocardium. In another example, the transmyocardial pledget 240 may cinch or collapse, which can result in expanding the girth of the transmyocardial pledget 240transversely or longitudinally during a process of deploying the pericardial anchoring system 200 across the heart wall. This can seal the channel or puncture through the myocardium. In another example, any combination of the modes of sealing a puncture or channel of the heart wall during a process of deploying the pericardial anchoring system 200 across the heart wall as discussed above is anticipated.[000185] A pledget aperture distance, or the distance between one of the plurality of pledget apertures and the next, can contribute to how the transmyocardial pledget cinches. For example, a pledget distance between at least two of the plurality of pledget apertures can be larger than a largest transverse dimension of the transmyocardial pledget 240 operable to fold the transmyocardial pledget 240 to an enlarged or larger dimension in the transverse direction when in the cinched configuration relative to the largest transverse dimension of the transmyocardial pledget 240 when in the elongated or pre-cinched configuration when tension is applied to the second end 380 of the pledget suture 300. The enlarged dimension may be greater or larger than a shortened dimension in the transverse direction of the transmyocardial pledget when in the elongated configuration or the cinched configuration. Similarly, for example, the pledget aperture distance between at least two pledget apertures is larger than twice the largest transverse dimension of the transmyocardial pledget operable to fold the transmyocardial pledget 240 to a larger dimension in the transverse direction when the cinched configuration relative to the largest transverse dimension of the transmyocardial pledget 240 when in the elongated configuration when tension is applied to the second end 380 of the pledget suture 300. This may allow the transmyocardial pledget 240 to fold in half. Additionally, for example the plurality of pledget apertures 320 may not be colinearly located along a longitudinal direction 247, as shown in FIG. 28, of the transmyocardial pledget 240 operable to fold the transmyocardial pledget 240 to the larger dimension in the transverse direction when in the cinched configuration relative to the largest transverse dimension of the transmyocardial pledget 240 when in the elongated configuration when tension is applied to the second end 380 of the pledget suture 300.[000186] The suture lock 270 can also capture the leaflet anchor suture 31 OA. The leaflet anchor suture 31 OA can extend between the leaflet anchor 300A implanted in a mitral valve leaflet 9 and the suture lock 270 to repair a mitral chord.LEAFLET ANCHOR IMPLANTED[000187] FIG. 35A is an example of the leaflet anchor implanted in the valve leaflet and the leaflet anchor suture 310A extending between the leaflet anchor 300A and the pericardial anchoring system 200 implanted at least in the ventricle wall. As shown, the pericardial anchoring system 200 is implanted in the ventricle wall, such that the anchor socket 260 is positioned against the endocardial surface of the heart wall 4s. The leaflet anchor 300A can be an anchor where at least a portion of the anchor is configured to be positioned in or on a leaflet. At least a portion of the pericardial anchor 220 can be embedded in or in contact with tissue of the leaflet. The leaflet anchor 300A can be a variety of shapes, such as a pledget, a clip, or a hook. The leaflet anchor suture 310A can extend from the suture lock 270 positioned within the anchor socket 260 and extend to the leaflet anchor 300A. The leaflet anchor 300A can be an anchor positioned within the mitral valve leaflet 9. The leaflet anchor 300A can be a pledget.[000188] FIG. 35B is a cross sectional view of the ventricular wall with the ventricular anchor system implanted. As shown, the pericardial anchor 220 can be positioned within the pericardial space 10. The transmyocardial pledget 240 can extend from the pericardial anchor 220, and through the puncture of the endocardium, myocardium, and epicardium. The transmyocardial pledget 240 can also be folded down against the endocardial surface of the heart wall 41 . The anchor socket 260 can be positioned against the endocardium of the heart wall 41 .[000189] FIG. 35C is a view of the pericardial anchor 220 implanted within the pericardial space.LEAFLET ANCHORING SYSTEM[000190] In accordance with an embodiment, the pericardial anchoring system 200 may be used to control the motion of a mitral valve leaflet by coupling the pericardial anchor suture 280 to one or more leaflet anchor sutures 310A, also referred to as tethers, that are themselves coupled to the mitral valve leaflet 9. After the pericardialanchor 220 and the transmyocardial pledget 240 are delivered to the target location, the pericardial anchor suture 280 may be coupled to the suture lock and coupled to the mitral valve leaflet 9 by use of a leaflet anchoring system 510. The leaflet anchoring system 510 includes a leaflet anchor 300A and a leaflet anchor suture 310A which is operable to pass through the mitral valve leaflet 9 and couple thereto. In some embodiments, the leaflet anchor may be delivered to the mitral valve prior to the delivery of the pericardial anchoring system. In some embodiments, the leaflet anchor sutures 310A may be coupled to the mitral valve leaflet 9 prior to the leaflet anchor sutures 310A coupling to the pericardial anchor suture 280 and / or the pledget suture.
Claims
CLAIMSWHAT IS CLAIMED IS:1 . A pericardial anchoring system, comprising: a pericardial anchor; a transmyocardial pledget extending from a proximal end of the pericardial anchor; and a transmyocardial pledget suture coupled to the transmyocardial pledget and operable to upon application of tension to an end of the transmyocardial pledget suture transform the transmyocardial pledget from an elongated configuration to a cinched configuration defining a shortened dimension in a longitudinal direction.
2. The pericardial anchoring system of claim 1 , wherein the transmyocardial pledget suture is operable to upon application of tension to an end of the transmyocardial pledget suture transform the transmyocardial pledget from an elongated configuration to a cinched configuration defining an enlarged dimension transverse to the longitudinal direction.
3. The pericardial anchoring system of any of Claims 1 and 2, wherein the transmyocardial pledget includes a plurality of pledget apertures located along a length of the transmyocardial pledget, the transmyocardial pledget suture extending sequentially through the plurality of pledget apertures.
4. The pericardial anchoring system of Claim 3, wherein the transmyocardial pledget suture is woven sequentially through the plurality of pledget apertures and sequentially located adjacent a transmyocardial pledget first side and a transmyocardial pledget second side that is opposite the transmyocardial pledget first side.
5. The pericardial anchoring system of any of Claims 3 and 4, wherein the transmyocardial pledget suture sequentially traverses through the plurality of pledget apertures from a transmyocardial pledget distal end to a transmyocardial pledget proximalend and back to the transmyocardial pledget distal end, wherein the transmyocardial pledget proximal end is adjacent the pericardial anchor.
6. The pericardial anchoring system of any of Claims 3-5, wherein the transmyocardial pledget suture includes a transmyocardial pledget suture first end and a transmyocardial pledget suture second end opposite the transmyocardial pledget suture first end, wherein the transmyocardial pledget suture first end includes a compressing element, the compressing element having a dimension that prevents the compressing element from passing through a first aperture of the plurality of pledget apertures, the compressing element operable to engage with and compress the transmyocardial pledget when tension is applied to the transmyocardial pledget suture second end.
7. The pericardial anchoring system of Claim 6, wherein the compressing element is a knot defined by the transmyocardial pledget suture first end.
8. The pericardial anchoring system of any of Claims 6 and 7, wherein the compressing element is configured to translate along the transmyocardial pledget suture second end.
9. The pericardial anchoring system of Claim 6, wherein the compressing element is the transmyocardial pledget suture first end defining a knot and a loop operable to slidingly receive the transmyocardial pledget suture second end therethrough.
10. The pericardial anchoring system of Claim 6, wherein the compressing element is a loop coupled to the transmyocardial pledget suture first end with the transmyocardial pledget suture second end slidingly receive therethrough.
11. The pericardial anchoring system of Claim 10, wherein the loop is a ring.
12. The pericardial anchoring system of any one of Claims 8-11 , wherein translation of the compressing element along the transmyocardial pledget suture secondend in a direction towards the pericardial anchor is configured to cinch the transmyocardial pledget.
13. The pericardial anchoring system of any one of Claims 8-12, further comprises a suture tail, the suture tail being integral with or coupled to the compressing element, wherein the transmyocardial pledget suture is operable to be removed from the transmyocardial pledget upon application of tension to the suture tail in a direction away from the pericardial anchor with the transmyocardial pledget suture slidingly removed from the plurality of pledget apertures.
14. The pericardial anchoring system of any of claims 2-12, wherein a pledget aperture distance between at least two pledget apertures is larger than a largest transverse dimension of the transmyocardial pledget operable to fold the transmyocardial pledget to a larger dimension in a transverse direction when in the cinched configuration relative to a pledget largest transverse dimension when in the elongated configuration when tension is applied to the transmyocardial pledget suture second end.
15. The pericardial anchoring system of any of claims 2-14, wherein a pledget aperture distance between at least two pledget apertures is larger than twice largest transverse dimension of the transmyocardial pledget operable to fold the transmyocardial pledget to a larger dimension in a transverse direction when in the cinched configuration relative to a pledget largest transverse dimension when in the elongated configuration when tension is applied to the transmyocardial pledget suture second end.
16. The pericardial anchoring system of any of claims 2-15, wherein the plurality of pledget apertures are not colinearly located along the longitudinal direction of the transmyocardial pledget operable to fold the transmyocardial pledget to a larger dimension in a transverse direction when in the cinched configuration relative to the largest transverse dimension of the transmyocardial pledget when in the elongated configuration when tension is applied to the transmyocardial pledget suture second end.
17. The pericardial anchoring system of any one of Claims 1-16, further comprising: a pericardial anchoring suture coupled to the pericardial anchor; a suture lock configured to interact with the pericardial anchoring suture; and an anchor socket configured to house the suture lock.
18. A pericardial anchoring system, comprising: a pericardial anchor; a transmyocardial pledget extending from a proximal portion of the pericardial anchor; a pericardial anchoring suture coupled to the pericardial anchor; a transmyocardial pledget suture coupled to the transmyocardial pledget; a suture lock configured to interact with the pericardial anchoring suture; and an anchor socket configured to house the suture lock, wherein the pericardial anchor is operable to be transformable between a predeployed configuration and a deployed configuration, wherein the transmyocardial pledget is operable to be transformable between a pre-cinched configuration and a cinched configuration, wherein the transmyocardial pledget and the pericardial anchor are independently operable.
19. The pericardial anchoring system of Claim 18, wherein the anchor socket is further configured to constrain and dock the suture lock.
20. The pericardial anchoring system of Claim 18, wherein the suture lock secures the pericardial anchoring suture.21 . The pericardial anchoring system of Claim 18, wherein the transmyocardial pledget includes a plurality of apertures located along a length of the transmyocardial pledget.
22. The pericardial anchoring system of Claim 21 , wherein the transmyocardial pledget suture is woven through the plurality of apertures.
23. The pericardial anchoring system of Claim 21 , wherein the transmyocardial pledget suture is woven through the plurality of apertures from a distal end to a proximal end and back to a distal end.
24. The pericardial anchoring system of Claim 18, wherein the transmyocardial pledget is configured to form a cinched shape, a bunch, or a wad in the cinched configuration.
25. The pericardial anchoring system of Claim 18, wherein the transmyocardial pledget suture includes a compressing element.
26. The pericardial anchoring system of Claim 25, wherein the compressing element is configured to translate along the transmyocardial pledget suture.
27. The pericardial anchoring system of Claim 25, wherein the compressing element is configured to translate along a second end of the transmyocardial pledget suture.
28. The pericardial anchoring system of Claim 25, wherein a first end of the transmyocardial pledget suture is slidingly received through the compressing element operable to translate along a second end of the transmyocardial pledget suture.
29. The pericardial anchoring system of Claim 26, wherein translation of the compressing element along the transmyocardial pledget suture in a direction towards the pericardial anchor is configured to cinch the transmyocardial pledget.
30. The pericardial anchoring system of Claim 25, wherein the compressing element is a non-slip loop knot.31 . The pericardial anchoring system of Claim 25, wherein the compressing element applies pressure to a surface of the transmyocardial pledget to transform the transmyocardial pledget to the cinched configuration.
32. The pericardial anchoring system of Claim 31 , wherein a minimal tension is applied to the transmyocardial pledget suture when the transmyocardial pledget is in the cinched configuration.
33. The pericardial anchoring system of Claim 21 , wherein a predetermined resistance between the transmyocardial pledget suture and the plurality of pledget apertures is operable to prevent relative movement with the transmyocardial pledget in the cinched configuration.
34. The pericardial anchoring system of Claim 31 , wherein translation of the compressing element along the transmyocardial pledget suture in a direction away from the pericardial anchor minimally effects the cinched configuration of the transmyocardial pledget.
35. The pericardial anchoring system of Claim 25, wherein the compressing element is a miniature pledget.
36. The pericardial anchoring system of Claim 25, wherein the compressing element is a compression sleeve.
37. A method of deploying a pericardial anchor system, comprising: applying tension to a pericardial anchor suture woven through a pericardial anchor to deploy; translating a compressing element along a pledget suture woven through a transmyocardial pledget in a pre-cinched configuration to transform the transmyocardial pledget to a cinched configuration; and locking the transmyocardial pledget in the cinched configuration.
38. The method of Claim 37, wherein the compressing element applies pressure to a surface of the transmyocardial pledget to transform the transmyocardial pledget to the cinched configuration.
39. The method of Claim 37, wherein a predetermined resistance locks the transmyocardial pledget in the cinched configuration.
40. The method of Claim 37, wherein the compressing element is translated in a direction towards the pericardial anchor to transform the transmyocardial pledget to the cinched configuration.41 . The method of Claim 37, wherein minimal tension is applied to the pledget suture when the transmyocardial pledget is in the cinched configuration.
42. The method of Claim 37 further comprising routing the pericardial anchor suture and the pledget suture through a suture lock within an anchor socket connected to the transmyocardial pledget.
43. The method of Claim 37, wherein deployment of the pericardial anchor includes formation of a disc.
44. A method of mitral valve chord repairment, the method comprising: anchoring a pericardial anchor by applying tension to a pericardial anchor suture integrated with the pericardial anchor; cinching a transmyocardial pledget by translating a compressing element along a pledget suture integrated with the transmyocardial pledget; connecting the pericardial anchor suture, the pledget suture, and at least one leaflet anchor suture integrated with at least one leaflet anchor to a suture lock within an anchor socket that is connected to the transmyocardial pledget; locking the pericardial anchor suture to the suture lock; and locking the at least one leaflet anchor suture.
45. The method of Claim 44, wherein the compressing element is translated in a direction towards the pericardial anchor to transform the transmyocardial pledget to a cinched configuration.
46. The method of Claim 45, wherein minimal tension is applied to the pledget suture when the transmyocardial pledget is in the cinched configuration.
47. The method of Claim 45, wherein a preferred resistance maintains the transmyocardial pledget in the cinched configuration.