Mitral valve leaflet repair system

The pericardial anchoring system, which combines pericardial anchors, myocardial swabs, and sutures, achieves safe and stable anchoring of medical devices in the heart chambers, solving the problem of unsafe anchoring in existing technologies and improving the fixation effect of the device.

CN120916707APending Publication Date: 2025-11-07PIPELINE MEDICAL TECHNOLOGIES INC
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Patent Information

Application Number
CN202480020742.2
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Priority Date
2023-01-20
Filing Date
2024-01-19
Publication Date
2025-11-07

AI Technical Summary

Technical Problem

In the current technology, the anchoring system of medical devices in the heart chamber is not safe enough, and a safer anchoring system is needed.

Method used

The pericardial anchoring system includes a pericardial anchor, a transmyocardial swab, and a transmyocardial swab suture. By applying tension to the suture, the swab changes from an elongated structure to a tightened structure, defining the longitudinal or lateral dimensions. The system utilizes multiple swab holes and compression elements to achieve anchoring stability and safety.

Benefits of technology

It improves the safety and stability of the anchoring system, reduces trauma to cardiac tissue, and enhances the fixation effect of the device in the pericardial space.

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Abstract

A pericardial anchoring system includes: a pericardial anchor; a transcardiac swab extending from the proximal end of the pericardial anchor; and a transcardiac swab suture coupled with the transcardiac swab. The transcardiac swab suture is operable to transition the transcardiac swab from an elongated configuration to a tightened configuration when tension is applied to one end of the transcardiac swab suture, the tightened configuration defining a shortened dimension in a longitudinal direction.
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Description

Cross Reference to Related Applications

[0001] This application claims the benefit of provisional patent application number 63 / 480,929, filed January 20, 2023, which is incorporated by reference herein in its entirety for all purposes. TECHNICAL FIELD

[0002] The present disclosure relates generally to cardiac device anchoring, and more particularly to apparatuses, systems, and methods including access and anchoring in the pericardial space. BACKGROUND

[0003] There is a need to anchor medical devices in chambers of the heart. Typically, these devices can have an anchor embedded in the myocardium (membrane). There remains a need for a safer anchoring system for such devices. SUMMARY

[0004] Described embodiments relate to apparatuses, systems, and methods for pericardial anchoring.

[0005] According to one example (“Example 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 with the transmyocardial pledget, the transmyocardial pledget suture operable to transition the transmyocardial pledget from an elongated configuration to a cinched configuration defining a shortened dimension in a longitudinal direction when tension is applied to an end of the transmyocardial pledget suture.

[0006] According to another example (“Example 2”), the pericardial anchoring system of Example 1, wherein the transmyocardial pledget suture is operable to transition the transmyocardial pledget from an elongated configuration to a cinched configuration defining an enlarged dimension transverse to the longitudinal direction when tension is applied to an end of the transmyocardial pledget suture.

[0007] According to another example (“Example 3”), the pericardial anchoring system of Example 1 or Example 2, wherein the transmyocardial pledget comprises a plurality of pledget holes positioned along a length of the transmyocardial pledget, the transmyocardial pledget suture extending through the plurality of pledget holes in sequence.

[0008] According to another example (“Example 4”), the pericardial anchoring system of Example 3, wherein the transmyocardial pledget suture extends through the plurality of pledget holes in sequence and is woven in sequence adjacent to a first side of the transmyocardial pledget and a second side of the transmyocardial pledget opposite the first side of the transmyocardial pledget.

[0009] According to another example ("Example 5"), the pericardial anchoring system of Example 3 or Example 4, wherein the transmyocardial swab suture traverses the plurality of swab holes sequentially from the transmyocardial swab distal end to the transmyocardial swab proximal end and back to the transmyocardial swab distal end, wherein the transmyocardial swab proximal end is adjacent to the pericardial anchor.

[0010] According to another example ("Example 6"), the pericardial anchoring system of any of Examples 3-5, wherein the transmyocardial swab suture includes a transmyocardial swab suture first end and a transmyocardial swab suture second end opposite the transmyocardial swab suture first end, wherein the transmyocardial swab suture first end includes a compression element having a size that prevents the compression element from passing through a first hole of the plurality of swab holes, the compression element operable to engage and compress the transmyocardial swab when tension is applied to the transmyocardial swab suture second end.

[0011] According to another example ("Example 7"), the pericardial anchoring system of Example 6, wherein the compression element is a knot defined by the transmyocardial swab suture first end.

[0012] According to another example ("Example 8"), the pericardial anchoring system of any of Examples 6-7, wherein the compression element is configured to translate along the transmyocardial swab suture second end.

[0013] According to another example ("Example 9"), the pericardial anchoring system of Example 6, wherein the compression element is a knot and a loop defined by the transmyocardial swab suture first end, the loop operable to slidingly receive the transmyocardial swab suture second end therethrough.

[0014] According to another example ("Example 10"), the pericardial anchoring system of Example 6, wherein the compression element is a loop coupled to the transmyocardial swab suture first end, the transmyocardial swab suture second end slidingly received through the loop.

[0015] According to another example ("Example 11"), the pericardial anchoring system of Example 10, wherein the loop is a ring.

[0016] According to another example ("Example 12"), the pericardial anchoring system of any of Examples 8-11, wherein translation of the compression element along the transmyocardial swab suture second end in a direction toward the pericardial anchor is configured to tighten the transmyocardial swab.

[0017] According to another example ("Example 13"), the pericardial anchoring system of any of Examples 8-12, comprising a suture tail that is integral with or coupled to the compression element, wherein the transmyocardial swab suture is operable to be removed from the transmyocardial swab upon application of tension to the suture tail in a direction away from the pericardial anchor, while the transmyocardial swab suture is slidably removed from the plurality of swab holes.

[0018] According to another example ("Example 14"), the pericardial anchoring system of any of Examples 2-12, wherein a swab hole distance between at least two swab holes is greater than a maximum transverse dimension of the transmyocardial swab, the transmyocardial swab operable to fold to a greater dimension in a transverse direction when in the cinched configuration relative to the swab maximum transverse dimension when in the elongated configuration upon application of tension to the transmyocardial swab suture second end.

[0019] According to another example (Example "15"), the pericardial anchoring system of any of Examples 2-14, wherein a swab hole distance between at least two swab holes is greater than twice a maximum transverse dimension of the transmyocardial swab, the transmyocardial swab operable to fold to a greater dimension in a transverse direction when in the cinched configuration relative to the swab maximum transverse dimension when in the elongated configuration upon application of tension to the transmyocardial swab suture second end.

[0020] According to another example ("Example 16"), the pericardial anchoring system of any of Examples 2-15, wherein the plurality of swab holes are not colinearly arranged along the longitudinal direction of the transmyocardial swab, the transmyocardial swab operable to fold to a greater dimension in a transverse direction when in the cinched configuration relative to the transmyocardial swab maximum transverse dimension when in the elongated configuration upon application of tension to the transmyocardial swab suture second end.

[0021] According to another example ("Example 17"), the pericardial anchoring system of any of Examples 1-16, the pericardial anchoring system of any 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.

[0022] According to another example ("Example 18"), a pericardial anchoring system, comprising: a pericardial anchor; a transmyocardial pledget extending from a proximal portion of the pericardial anchor; a pericardial anchor suture coupled to the pericardial anchor; a transmyocardial pledget suture coupled to the transmyocardial pledget; a suture lock configured to interact with the pericardial anchor suture; and an anchor socket configured to house the suture lock, wherein the pericardial anchor is operable to transition between a pre-deployed configuration and a deployed configuration, wherein the transmyocardial pledget is operable to transition between a pre-tightened configuration and a tightened configuration, wherein the transmyocardial pledget and the pericardial anchor are independently operable.

[0023] According to 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] According to another example ("Example 20"), the pericardial anchoring system of Example 18, wherein the suture lock secures the pericardial anchor suture.

[0025] According to another example ("Example 21"), the pericardial anchoring system of Example 18, wherein the transmyocardial pledget comprises a plurality of holes positioned along a length of the transmyocardial pledget.

[0026] According to another example ("Example 22"), the pericardial anchoring system of Example 21, wherein the transmyocardial pledget suture is woven through the plurality of holes.

[0027] According to another example ("Example 23"), the pericardial anchoring system of Example 21, wherein the transmyocardial pledget suture is woven through the plurality of holes from a distal end to a proximal end and back to the distal end.

[0028] According to another example ("Example 24"), the pericardial anchoring system of Example 18, wherein the transmyocardial pledget is configured to form a tightened shape, bundle, or mass in the tightened configuration.

[0029] According to another example ("Example 22"), the pericardial anchoring system of Example 21, wherein the transmyocardial pledget suture comprises a compression element.

[0030] According to another example (Example "26"), the pericardial anchoring system of Example 25, wherein the compression element is configured to translate along the transmyocardial pledget suture.

[0031] According to another example (Example "27"), the pericardial anchoring system of Example 25, wherein the compression element is configured to translate along a second end of the transmyocardial pledget suture.

[0032] According to another example (Example "28"), the pericardial anchoring system of Example 25, wherein the transmyocardial swab suture first end is slidably received through the compression element, the compression element operable to translate along the transmyocardial swab suture second end.

[0033] According to another example (Example "29"), the pericardial anchoring system of Example 26, wherein translation of the compression element along the transmyocardial swab suture in a direction toward the pericardial anchor is configured to tighten the transmyocardial swab.

[0034] According to another example (Example "30"), the pericardial anchoring system of Example 25, wherein the compression element is a thimble.

[0035] According to another example (Example "31"), the pericardial anchoring system of Example 25, wherein the compression element applies pressure to a surface of the transmyocardial swab to transform the transmyocardial swab to the tightened configuration.

[0036] According to another example (Example "32"), the pericardial anchoring system of Example 31, wherein a minimal tension is applied to the transmyocardial swab suture when the transmyocardial swab is in the tightened configuration.

[0037] According to another example (Example "33"), the pericardial anchoring system of Example 21, wherein a predetermined resistance between the transmyocardial swab suture and the plurality of swab holes is operable to prevent relative movement of the transmyocardial swab suture and the transmyocardial swab in the tightened configuration.

[0038] According to another example (Example "34"), the pericardial anchoring system of Example 31, wherein translation of the compression element along the transmyocardial swab suture in a direction away from the pericardial anchor has minimal effect on the tightened configuration of the transmyocardial swab.

[0039] According to another example (Example "35"), the pericardial anchoring system of Example 25, wherein the compression element is a microswab.

[0040] According to another example (Example "36"), the pericardial anchoring system of Example 25, wherein the compression element is a compression sleeve.

[0041] According to another example ("Example 37"), a method of deploying a pericardial anchoring system, comprising: applying tension to a pericardial anchor suture woven through a pericardial anchor to deploy; translating a compression element along a swab suture woven through a transmyocardial swab in a pre-tightened configuration to transform the transmyocardial swab to a tightened configuration; and locking the transmyocardial swab in the tightened configuration.

[0042] According to another example (Example "38"), the pericardial anchoring system of Example 37, the compression element applies pressure to a surface of the transmyocardial pledget to transform the transmyocardial pledget to the cinched configuration.

[0043] According to another example (Example "39"), the pericardial anchoring system of Example 37, wherein a predetermined resistance locks the transmyocardial pledget in the cinched configuration.

[0044] According to another example (Example "40"), the pericardial anchoring system of Example 37, wherein the compression element translates in a direction toward the pericardial anchor to transform the transmyocardial pledget to the cinched configuration.

[0045] According to 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] According to another example (Example "42"), the pericardial anchoring system of Example 37, further comprising guiding the pericardial anchor suture and the pledget suture through a suture lock within an anchor socket connected to the transmyocardial pledget.

[0047] According to another example (Example "43"), the pericardial anchoring system of Example 37, wherein deployment of the pericardial anchor comprises forming a disc.

[0048] According to another example (Example "44"), a method of mitral chord repair, 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 compression 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 connected to the transmyocardial pledget; locking the pericardial anchor suture to the suture lock; and locking the at least one leaflet anchor suture.

[0049] According to another example (Example "45"), the pericardial anchoring system of Example 44, wherein the compression element translates in a direction toward the pericardial anchor to transform the transmyocardial pledget to a cinched configuration.

[0050] According to 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] According to another example (Example "47"), the pericardial anchoring system of Example 45, wherein a preferred resistance (a predetermined resistance) maintains the transmyocardial pledget in the cinched configuration. Attached Figure Description

[0052] The accompanying drawings are included to provide a further understanding of this disclosure, and are incorporated in and form a part of this specification, illustrating embodiments and serving, together with the specification, to explain the principles of this disclosure.

[0053] Figure 1A This is a side view of an anchoring system according to one embodiment;

[0054] Figure 1B yes Figure 1A Side view of the anchoring system;

[0055] Figure 2A It is a cross-sectional view of the heart;

[0056] Figure 2B yes Figure 2A An enlarged cross-sectional view of the heart;

[0057] Figure 3 This is a cross-sectional view of a heart with a guide wire according to an embodiment of a method for providing a pericardial anchoring system;

[0058] Figure 4 This is a cross-sectional view of a heart with a guide wire according to an embodiment of a method for providing a pericardial anchoring system;

[0059] Figure 5A This is a cross-sectional view of a heart with a guide wire according to an embodiment of a method for providing a pericardial anchoring system;

[0060] Figure 5B This is a cross-sectional view of a heart with a guide wire according to an embodiment of a method for providing a pericardial anchoring system;

[0061] Figure 6 This is a cross-sectional view of a heart having a guide wire and a needle catheter according to an embodiment of a method for providing a pericardial anchoring system;

[0062] Figure 7 This is a cross-sectional view of a heart having a guide wire and a needle catheter according to an embodiment of a method for providing a pericardial anchoring system;

[0063] Figure 8 This is a cross-sectional view of a heart having a guide wire and a catheter according to an embodiment of a method for providing a pericardial anchoring system;

[0064] Figure 9 This is a cross-sectional view of a heart having a catheter and an anchoring system according to an embodiment of a method for providing a pericardial anchoring system;

[0065] Figure 10is a cross-sectional view of a heart with a catheter and an anchor system that has been deployed according to an embodiment of a method of providing a pericardial anchor system;

[0066] Figure 11 is a cross-sectional view of a heart with an anchor system that has been deployed according to an embodiment of a method of providing a pericardial anchor system;

[0067] Figure 12 is a cross-sectional view of a heart with an anchor system that has been deployed with a sealing device according to an embodiment of a method of providing a pericardial anchor system;

[0068] Figure 13 is a cross-sectional view of a heart with an anchor system that has been deployed with a tether lock according to an embodiment of a method of providing a pericardial anchor system;

[0069] Figure 14 is a cross-sectional view of a heart with an anchor system that has been deployed and coupled to a mitral valve leaflet to prevent prolapse according to an embodiment of a method of providing a pericardial anchor system;

[0070] Figure 15 is a flowchart of an embodiment of a method of providing a pericardial anchor system;

[0071] Figure 16 is a flowchart of an embodiment of a method of providing a pericardial anchor system;

[0072] Figure 17 is a flowchart of an embodiment of a method of providing a pericardial anchor system;

[0073] Figure 18 is an example of a pericardial anchor system in a flat open configuration according to an embodiment.

[0074] Figure 19 is an example of the pericardial anchor system of FIG. 21 with the pericardial anchor in a deployed configuration and the transmyocardial swab in a pre-deployed configuration.

[0075] Figure 20 is an example of the pericardial anchor system of FIG. 21 and Figure 22 in a fully deployed configuration.

[0076] Figure 21A is an example of a wire frame of a pericardial anchor in a deployed configuration according to an embodiment.

[0077] Figure 21B is an example of a transmyocardial swab with a T-bar proximal leg.

[0078] Figure 22 is an example embodiment of a transmyocardial swab in a pre-tightened configuration.

[0079] Figure 23 is a close-up view of an example embodiment of a compression element.

[0080] Figure 24 is a close-up view of an example embodiment of a compression element.

[0081] Figure 25A is a rear view of an example embodiment of a pledget suture path.

[0082] Figure 25B is a front view of an example embodiment of a pledget suture path.

[0083] Figure 26 is an example embodiment of a transmyocardial pledget in a cinched configuration.

[0084] Figure 27A is an example embodiment of a pledget suture.

[0085] Figure 27B is a close-up view of an example embodiment of a compression element.

[0086] Figure 28 is an example embodiment of a pericardial anchoring system.

[0087] Figure 29 is an isometric view of an example embodiment of a pledget.

[0088] Figure 30 is a top view of an example embodiment of a pledget.

[0089] Figure 31A is a top view of an example embodiment of a pledget.

[0090] Figure 31B is a side view of an example embodiment of a pledget.

[0091] Figure 31C is an isometric view of an example embodiment of a pledget.

[0092] Figure 31D is a close-up view of an example embodiment of a compression element.

[0093] Figure 32A is a top view of an example embodiment of a pledget.

[0094] Figure 32B is a side view of an example embodiment of a pledget.

[0095] Figure 32C is an isometric view of an example embodiment of a pledget.

[0096] Figure 32D is a close-up view of an example embodiment of a compression element.

[0097] Figure 33Ais an example embodiment of a microswab.

[0098] Figure 33B is an example embodiment of a microswab.

[0099] Figure 33C is an example embodiment of a microswab.

[0100] Figure 33D is an example embodiment of a microswab;

[0101] Figure 34 is an example of a pericardial anchor system and a leaflet anchor system deployed and implanted in a heart according to an embodiment.

[0102] Figure 35A is an example of a leaflet anchor implanted in a valve leaflet and a leaflet anchor suture extending between the leaflet anchor and a pericardial anchor system implanted in a heart chamber wall according to an embodiment.

[0103] Figure 35B is a cross-sectional view of a heart chamber wall implanted with a pericardial anchor system according to an embodiment.

[0104] Figure 35C is a view of a pericardial anchor implanted within a pericardial cavity according to an embodiment (pericardium not shown for clarity). DETAILED DESCRIPTION

[0105] Those skilled in the art will readily understand that the various aspects of the present disclosure can be implemented by any number of methods and devices configured to perform the intended functions. It should also be noted that the figures referred to herein are not necessarily drawn to scale, but can be exaggerated to illustrate various aspects of the present disclosure, and as such, the figures should not be understood to be limiting.

[0106] While the embodiments herein can be described in connection with various principles and concepts, the described embodiments should not be limited by theory. For example, embodiments are described herein in connection with preventing mitral valve leaflet prolapse by means of an anchor system contained within a pericardial space. However, embodiments within the scope of the present disclosure can be applied to any prosthesis or mechanism having similar structure and / or function that requires anchoring within a chamber of the heart.

[0107] Embodiments herein include various devices, systems, and methods for suture or other tethering mechanisms having an anchor positioned within the pericardial space, with the suture extending through the myocardium and endocardium for coupling with a biological element such as a mitral valve or a prosthesis such as but not limited to a sensor or a support structure. The anchor positioned within and adjacent to the epicardium (visceral layer of the serous pericardium) can have any suitable structure such as but not limited to an umbrella element, a pledget, a multi-legged support structure, etc. The anchor is operable to have a small profile, enabling passage through a narrow access in the heart wall and expansion or deployment to a larger diameter or surface area within the pericardial space, and not through a narrow access in the heart structure. The present disclosure is directed to mitral valve repair or replacement, and more generally to methods and devices for remodeling of the mitral valve, repair and / or replacement of the chordae of the mitral valve, also referred to as chordae tendinae, to restore normal function of the mitral valve from a failed state such as but not limited to mitral regurgitation.

[0108] As used herein, the term "heart wall" is defined as the endocardium, myocardium, and epicardium.

[0109] As used herein, the terms "pericardial space" and "pericardial cavity" are the space defined by the heart wall and the pericardium and in between, or the space between the visceral pericardium and the parietal pericardium.

[0110] As used herein, the term "coupled" means joined, connected, attached, adhered, fixed, or the like, either directly or indirectly, permanently or temporarily.

[0111] As used herein, the term "pericardial anchor" is used to describe the anchor of a pericardial anchoring system, however, the anchor of a pericardial system can also be referred to as a pericardial anchor or an anchor.

[0112] According to an embodiment, and as provided in Figure 17 According to an embodiment, and as provided in

[0113] Due to the extremely small profile, the risk of adverse events can be reduced, such as less likely to cause pericardial effusion / pericardial tamponade.

[0114] Use of a guide wire instead of a needle catheter through the epicardium can result in an increase in safety and an increase in ease of use of the procedure by, for example, eliminating the guesswork / ambiguity of going too short or too far into the pericardial space, as imaging and / or knowledge of this space is challenging for placement into the pericardial space. For example, the choice of guide wire stiffness is optimized at the distal tip and along the entire length such that, but not limited to, the distal tip is stiff enough that it can pass through the rest of the heart wall and into the pericardial space, yet soft enough to deflect without puncturing the pericardium (the parietal layer of the serous pericardium and the fibrous pericardium). The guide wire can be operable to coil within and travel within the pericardial space. Advancement of the guide wire distal end within the pericardial space and adjacent to the heart wall can provide evidence to the clinician that the distal end of the guide wire is within the pericardial space.

[0115] Where the guide wire outer diameter is only slightly smaller than the needle inner diameter, potential coring out of the heart wall is mitigated or minimized, thus reducing tissue trauma. The needle catheter and guide wire can be introduced together with the guide wire distal tip slightly pulled back, i.e., nested or in tandem, relative to the needle catheter distal tip. After the needle catheter punctures the endocardium, the guide wire can be advanced beyond the needle catheter distal tip, and the needle catheter provides support for the guide wire.

[0116] It should be appreciated that there are different ways to advance the small, hollow needle catheter and subsequently the nested guide wire to the target location. In one embodiment, the needle catheter can be advanced over the wire in a transluminal procedure, over a previously placed guide wire, such as but not limited to from an access port in the femoral vein. In other embodiments, the needle catheter with or without the nested guide wire can be advanced through the lumen of a previously placed steerable or non-steerable sheath, support / guide catheter, etc.

[0117] It should be appreciated that after the guide wire is passed through the pericardial space, some additional steps can be required to be performed before the anchor system is advanced. By way of example, but not limited thereto, the use of contrast, C02, microcatheters, various guide wires, support / guide catheters, and other devices, agents, and therapies can be used for specific purposes. Such devices, agents, and therapies can be provided to, but not limited to, create a physical space in the pericardial space at the target location, visualize the pericardial space and / or heart / pericardial structures at the target location, ensure that a sufficiently stiff and correctly diametered guide wire is obtained within the pericardium to deliver the anchor system.

[0118] According to embodiments, a diagnostic approach can be employed to provide evidence that the guide wire has passed through the heart wall and into the pericardial space. By way of example, such diagnostic approaches can include, but are not limited to, a guide wire attached to the ECG guide (such as a guide wire having a non-conductive coating in addition to the proximal and distal tips) and a pressure sensing guide wire having a sensing element at its distal tip. Data collected from these approaches can provide evidence that the guide wire has passed through the heart wall and into the pericardial space. Pericardial anchoring system

[0119] Figure 1A and 1B is a side view of an anchoring system 30, which includes an anchor 32 and a tether 34 coupled to the anchor 32. The anchor 32 is operable to have a small profile 33 in a first position 36 and a larger profile 37 in a second position 38. The anchor 32 is operable to advance in the first position 36 from a heart chamber 6 of a heart 2 through a narrow access passage 12 in a heart wall 41 into a pericardial space 10, and to expand in the pericardial space 10 into the second position 38 to a size larger than the narrow access passage 12.

[0120] Figure 2A and Figure 2B is a cutaway view of the heart 2 and its corresponding anatomical features. Guide wire advancement / insertion

[0121] Figures 3-14 is a series of illustrations of a method of providing an anchor 32 in a heart chamber 6 according to an embodiment, and Figure 15 is a flowchart thereof. The femoral vein is accessed, and a guide wire 40 is advanced therein. The guide wire 40 is advanced through the femoral vein and into the right atrium 20, Figure 3 . The guide wire 40 is advanced through the septum 26 and into the left atrium 24, Figure 4 . The guide wire 40 is advanced through the mitral valve 8, and advanced until and adjacent to the heart wall 41 of the left ventricle 22, Figure 5A and 5B . A needle catheter 42 is advanced over the guide wire 40 and into about half the thickness 16 of the myocardium 13, Figure 6 . The guide wire 40, having a stiff distal tip, is advanced through the needle catheter 42, through the epicardium 14 and into the pericardial space 10, Figure 7 . The length of the guide wire advanced into the pericardial space 10 can be minimized. The guide wire can be configured to coil or take on a coiled shape as it is advanced into the pericardial space 10. Minimizing the length of the guide wire inserted into the pericardial space 10 can facilitate preserving the integrity of the heart wall. A catheter 44 is advanced over the guide wire 40 and into the pericardial space 10, Figure 8The pericardium 18 can be inflated and separated from the heart wall 41 using a gas such as carbon dioxide to enlarge the pericardial space 10. The anchoring system 30 can be advanced over the guide wire 40 after the catheter 44 is removed, and / or can be advanced through the catheter 44 after the guide wire 40 is removed, Figure 9 , or over the guide wire 40 while the guide wire 40 remains in the catheter 44. The anchoring system 30 can benefit from an anchoring system delivery catheter operable to deliver and deploy the anchoring system. The anchors are deployed within the pericardial space 10 and placed opposite the epicardium 14, Figure 10 . The anchoring system 30 includes sutures or tethers 34 coupled to the anchors 32, where the sutures or tethers 34 remain in the heart chamber 6, Figure 11 .

[0122] It is contemplated that once the delivery system, i.e. any guide wire 40 and / or catheter 44, is removed from the heart 2, the heart wall 41 will seal around the sutures or tethers 34 such that additional material is not needed to prevent blood from the left ventricle from moving into the pericardial space, which can be caused by the formation of the access passage 12. It is contemplated that alternatively, a sealing device 48 can be provided to reduce or eliminate the potential for blood to move from the left ventricle into the pericardial space. Such a sealing device 48 can include, but is not limited to, a surface texture on the tethers 34 causing a healing response between the tethers 34 and the heart wall 41; a pledget along the tethers 34 that can be used to plug the access passage 12; an expandable portion or element around the tethers 34 and / or anchors 32 operable to close the access passage 12 around the tethers 34 and / or anchors, Figure 12 .

[0123] In some embodiments, there can be a three-stage sealing that can occur upon removal of the delivery system from the access passage. The access passage can be sealed from the inside of the epicardium, from the outside of the epicardium, and through the epicardium by the access passage. The size of the delivery system can affect the amount or degree of sealing that can be made after the delivery system is removed. In some embodiments, the smaller the delivery system, the easier it is to achieve a three-stage sealing and return the epicardium to a pre-injury state.

[0124] In another embodiment shown in Figure 13 , a tether lock 35 is advanced over the tether 34 and abuts the endocardium 11, the tether lock operable to engage the tether 34 and hold fast to capture the heart wall 41 between the tether lock 35 and the anchors. Such a tether lock 35 can be operable to ensure a push engagement of the anchors 32 with the endocardium 11 to prevent its movement, for example, to prevent any subsequent irritation of the pericardial membrane 18.

[0125] As provided previously, the suture or tether 34 can be used for a particular purpose. According to one embodiment, the suture or tether 34 is coupled to a mitral valve leaflet 9 to prevent leaflet prolapse, as shown in Figure 14

[0126] According to another embodiment, the suture or tether 34 can be coupled to a device such as a prosthetic valve.

[0127] According to another embodiment, the suture or tether 34 can be coupled to a device such as a sensor. Anchor deployment overview

[0128] According to another embodiment, as provided in the flowchart of Figure 16 and with reference to FIGS. 1-14, the anchoring method includes advancing a guide wire 40 into the heart 2 until and adjacent to the heart wall 41. The length of the guide wire advanced into the pericardial space 10 can be minimized. The guide wire can be configured to coil or take on a coiled shape as it is advanced into the pericardial space 10. Minimizing the length of the guide wire inserted into the pericardial space 10 can facilitate maintaining the integrity of the heart wall. A catheter 42 is advanced over the guide wire 40 and into about half the thickness 16 of the heart wall 41. The guide wire 40 is advanced through the needle catheter 42, through the epicardium 14 and into the pericardial space 10. The needle catheter 42 is withdrawn from the guide wire 40. A catheter 44 is advanced over the guide wire 40 and into the pericardial space 10. The pericardium 18 is separated from the heart wall 41 to enlarge the pericardial space 10. The anchor system 30 is advanced over the guide wire 40 or advanced through the catheter 44 with its anchor portion 39 placed into the pericardial space 10. The anchor 32 of the anchor system 30 is deployed within the pericardial space 10 and placed opposite the epicardium 14. The guide wire 40 and / or the catheter 44 are removed from the patient, leaving the tether 34 coupled to the anchor 32 in the heart chamber 6.

[0129] ​According to another embodiment, the anchoring method includes optionally advancing a support catheter into the heart, proximal to or to and against the heart wall. The anchor catheter is advanced separately or through the optional support catheter and placed in engagement against or proximal to the heart wall. The guide wire is advanced through the anchor catheter, through the endocardium, through the myocardium and through the epicardium (visceral layer of the serous pericardium) of the heart wall into the pericardial space. The anchor catheter is advanced over the guide wire and through the endocardium, through the myocardium and through the epicardium (visceral layer of the serous pericardium) of the heart wall into the pericardial space. Optionally, the guide wire is withdrawn from the pericardial space. Optionally, the pericardium is separated from the epicardium to enlarge the pericardial space. The anchor of the anchoring system is advanced or exposed through or at the distal end of the anchor catheter located in the pericardial space, with the anchor being placed into the pericardial space. The anchor of the anchoring system is deployed within the pericardial space and the anchor is placed opposite the epicardium. The guide wire and / or the anchor catheter and / or the support catheter are removed from the patient, leaving a tether coupled to the anchor in the heart chamber.

[0130] According to another embodiment of the anchoring method, includes advancing an anchor catheter proximal to or up to and against the heart wall in the heart chamber. The guide wire is advanced through the anchor catheter such that the guide wire distal tip is advanced through the endocardium and into the myocardium, through the epicardium and into the pericardial space. The distal tip of the anchor catheter is advanced along or over the guide wire and into or adjacent to the pericardial space. The anchor of the anchoring system is advanced or exposed through or at the distal end of the anchor catheter located in the pericardial space, with the anchor being placed in the pericardial space. The anchor of the anchoring system is deployed within the pericardial space and the anchor is placed opposite the epicardium. The guide wire and / or the anchor catheter and / or the support catheter are removed from the patient, leaving a tether coupled to the anchor in the heart chamber of the anchoring system on the guide wire and into the pericardial space. Anchoring method

[0131] An anchoring method according to an embodiment includes providing an anchoring system as described above; advancing a guidewire into a femoral 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 until reaching and abutting a heart wall of a left ventricle; advancing a needle catheter over the guidewire and through the endocardium into the myocardium of the heart wall; advancing the guidewire through the needle catheter through the myocardium and through the epicardium into a pericardial space; withdrawing the needle catheter from the guidewire; advancing a catheter over the guidewire and into the pericardial space; inflating a pericardium and detaching from the heart wall, thereby enlarging the pericardial space; advancing the anchoring system over the guidewire or through the catheter with the anchor placed into the pericardial space; deploying the anchor of the anchoring system within the pericardial space and placing the anchor opposite the epicardium, wherein the anchor is in a flat configuration in the pre-deployed configuration via tension on the tether first end and the tether second end, and wherein the anchor is in a loop configuration in the deployed configuration via tension on the tether first end and the tether second end; and removing the guidewire and / or the catheter from the patient, leaving the tether coupled to the anchor in the heart chamber.

[0132] An anchoring method according to an embodiment includes providing an anchoring system as described above; advancing a guidewire into a needle catheter such that the guidewire distal tip is adjacent to the 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 epicardium and into a pericardial space; and advancing an 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 flat configuration in the pre-deployed configuration via tension on the tether first end and the tether second end, and wherein the anchor is in a loop configuration in the deployed configuration via tension on the tether first end and the tether second end.

[0133] An anchoring method according to an embodiment includes providing an anchoring system as described above; advancing the support catheter into the heart until and adjacent or against the heart wall; advancing the anchor catheter alone or through the support catheter and placed to pushingly engage against the heart wall; advancing the guide wire along or over the anchor catheter through the endocardium, through the myocardium and through the epicardium (visceral layer of the serous pericardium) of the heart wall into the pericardial space; advancing the anchor catheter along or over the guide wire and through the endocardium, through the myocardium and through the epicardium (visceral layer of the serous pericardium) of the heart wall into the pericardial space; advancing or exposing the anchor of the anchoring system through or at the distal end of the anchor catheter in the pericardial space, wherein the anchor is placed into the pericardial space; deploying the anchor of the anchoring system within the pericardial space and placing the anchor against the epicardium, wherein the anchor is in a flat configuration in the pre-deployed configuration via tension on the tether first end and the tether second end, and wherein the anchor is in a loop configuration in the deployed configuration via tension on the tether first end and the tether second end; and removing the guide wire and the anchor catheter from the patient, leaving the tether coupled to the anchor in the heart chamber.

[0134] An anchoring method according to an embodiment includes providing an anchoring system as described above; advancing the support catheter into the heart until and adjacent or against the heart wall; advancing the anchor catheter alone or through the support catheter and placed to pushingly engage against the heart wall; advancing the guide wire along or over the anchor catheter through the endocardium, through the myocardium and through the epicardium (visceral layer of the serous pericardium) of the heart wall into the pericardial space; advancing the anchor catheter along or over the guide wire and through the endocardium, through the myocardium and through the epicardium (visceral layer of the serous pericardium) of the heart wall into the pericardial space; advancing or exposing the anchor of the anchoring system through or at the distal end of the anchor catheter in the pericardial space, wherein the anchor is placed into the pericardial space; deploying the anchor of the anchoring system within the pericardial space and placing the anchor against the epicardium, wherein the anchor is in a flat configuration in the pre-deployed configuration via tension on the tether first end and the tether second end, and wherein the anchor is in a loop configuration in the deployed configuration via tension on the tether first end and the tether second end; and removing the guide wire and the anchor catheter from the patient, leaving the tether coupled to the anchor in the heart chamber. Skirt of anchor with wire frame

[0135] The pericardial anchor 220 can include a wire or wire frame 222 coupled to a skirt 230. FIG. 21 is a plan view of a wire frame 222 in an unconstrained curved configuration, according to an embodiment. The wire or wire frame 222 can be made of nitinol, such as platinum-filled nitinol. As shown in FIG. 21, the wire frame 222 can include a first end 222a, a second end 222b, and a loop 222c. The first end 222a and the second end 222b can be coupled to the skirt 230. The loop 222c can be configured to be placed against the epicardium. The loop 222c can be configured to be deployed against the epicardium. The loop 222c can be configured to be deployed against the epicardium in a deployed configuration. The loop 222c can be configured to be deployed against the epicardium in a loop configuration. The loop 222c can be configured to be deployed against the epicardium in a loop configuration via tension on the tether first end and the tether second end. The loop 222c can be configured to be deployed against the epicardium in a loop configuration via tension on the tether first end and the tether second end in the deployed configuration. Figure 18As shown, the skirt 230 or membrane can be any suitable biocompatible material, such as, but not limited to, fluoropolymer membranes, such as expanded polytetrafluoroethylene (ePTFE) and expanded polyethylene (ePE). The skirt 230 can have properties that are operable to facilitate tissue ingrowth. The material of the skirt 230 can have additional properties, such as flexibility and durability, to withstand disc formation. For example, the material of the skirt 230 can resist breaking or tearing during disc formation.

[0136] The skirt 230 can include a material that is suitable for a particular use. For example, the material of the skirt 230 can be suitably flexible or compliant to facilitate deployment of the anchor from a flat configuration to a deployed configuration without tearing and / or unduly restricting deployment. For example, the material of the skirt can be suitably flexible so as not to overcome or unduly restrict the bias of the wire frame to the curved configuration. Further, the skirt material can be suitably flexible so as to conform to the epicardium once deployed. In addition, the skirt material can be suitably durable to be structurally robust under the dynamic motion of a beating heart for a period of time after deployment.

[0137] 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 terminal ends of the wire frame 222. The distal eyelet 224 and the proximal eyelet 226 can be atraumatic ends of the wire frame 222. As shown, Figure 21A As shown, the distal eyelet 224 can be located at the end of the wire frame. This can allow the end of the wire frame to be atraumatic to the tissue that the end of the wire frame can contact. For example, the distal eyelet 224 can prevent the end of the wire frame from damaging tissue that the end of the wire frame can contact. As further shown in FIG. 21, the proximal eyelet 226 can be adjacent to and spaced apart from the end of the wire frame 222. This can allow the end of the wire frame to be located within an area enclosed by the wire frame 222. In other words, this can allow the end of the wire frame to be located inside of or protected by the perimeter of the wire frame 222. In addition, the proximal eyelet 226 can prevent the end of the wire frame from damaging tissue that the end of the wire frame can contact. As further shown in FIG. 21, the proximal eyelet 226 can be located at the end of the wire frame. This can allow the end of the wire frame to be atraumatic to the tissue that the end of the wire frame can contact. For example, the proximal eyelet 226 can prevent the end of the wire frame from damaging tissue that the end of the wire frame can contact. Figure 21BAs shown, 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 flat 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 a puncture in the myocardium in the epicardial cavity. This positioning can not only seal the puncture, but also assist in preventing the pericardial anchor from deploying non-flatly and unfolding under the T-bar. For example, the positioning of the T-bar 290 can form a surface for the pericardial anchor to unfold onto. The T-bar 290 covered with the membrane can be integral with or separate from the transmyocardial swab 240. In some embodiments, the T-bar 290 can be deployed or positioned to seal the puncture before or after the skirt 230 is coiled.

[0138] The proximal leg 228 can be positioned distal to the proximal eyelet 226 of the wire frame 222 in the flat configuration. The proximal leg 228 can be a flat portion of the wire frame 222 that remains flat in both the flat configuration and the curved configuration, which in this embodiment is in the shape of a loop.

[0139] The proximal leg 228 can be reinforced compared to the rest of the wire frame 222, such as to resist tension or bearing forces. According to an embodiment, the proximal leg 228 can comprise two portions of the same wire folded over on itself, such that they are parallel to each other and can be in contact with each other, and can be coupled together. In some embodiments, the proximal leg 228 can have material properties that are stiffer than the rest of the wire. This advantageously allows the proximal leg 228 to resist bending and remain flat during deployment of the pericardial anchor 220, for example when against the distal end of the delivery catheter, while the rest of the wire frame 222 can unfold to form the curved configuration. Further, this advantageously allows an operator of the pericardial anchor system 200 to experience enhanced actuation and enhanced haptic feedback when the proximal leg 228 is deployed and retracted. In one embodiment, the proximal leg 228 is configured to remain flat and seat the pericardial anchor 220 against the distal end of the delivery catheter 502 and the puncture in the epicardium to keep the pericardial anchor 220 within the pericardial space and prevent the proximal leg 228 from passing through the epicardium or back into the distal end of the delivery catheter 502 once in the pericardial space. The proximal leg 228 is operable to prevent the pericardial anchor 220 from being pulled proximally through the puncture in the epicardium.

[0140] According to an embodiment, the proximal leg 228 is configured to maintain the flat configuration such that in combination with the curved bias of the rest of the wire frame 222 presents a profile that is operable to facilitate deployment of the pericardial anchor 220 in conjunction with a pushing engagement with the delivery catheter. According to another embodiment, the proximal leg 228 is configured to maintain the flat configuration such that in combination with the curved bias of the rest of the wire frame 222 presents a profile that is operable to prevent the anchor from passing through the puncture in the epicardium once deployed.

[0141] 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, the tether or pericardial anchor suture 280 is coupled to opposite edges of the skirt 230. According to another embodiment, a plurality of anchor holes 232 are positioned along an edge of the skirt 230 opposite the wire frame 222. The tether or pericardial anchor suture 280 is alternately woven through and slidably received through the plurality of anchor holes 232. The plurality of anchor holes 232 can be arranged in a pattern or randomly arranged along the edge of the skirt 230. For example, the plurality of anchor holes 232 can be arranged in a straight arrangement, a zigzag arrangement, or the like. 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. According to one embodiment, the suture attachment 234 can be a reinforced portion of the skirt 230, where the reinforced portion is reinforced with additional material or added auxiliary material to facilitate and strengthen the coupling. In another embodiment, the reinforced portion can have different material properties, such as but not limited to pressure and / or heat densification, such as with a porous material. The suture attachment 234 can be located at a distal end or distal portion of the skirt 230. This can advantageously improve deployment of the pericardial anchor 220 and maintenance of tension of the pericardial anchor suture 280. According to one embodiment, the suture attachment 234 at the distal end or distal portion of the skirt 230 in cooperative engagement with the anchor holes 232 in the skirt 230 results in a predetermined amount of force distribution along the skirt 230 as compared to a more concentrated load at the attachment point located at a more proximal location on the skirt 230.

[0142] The entire wire frame 222 can be coupled to the skirt 230. In one embodiment, the skirt 230 covers the entire wire frame 222, such as for example by being located within a fold or hem of the membrane or embedded within the layer(s) of the membrane, which can improve stability of the pericardial anchor 220 in the event of breakage or damage to the wire frame 222. The skirt 230 covering the wire frame 222 can additionally prevent the pericardial anchor suture 280 from going off course or becoming entangled with the wire frame 222, particularly during a transition between a pre-deployed configuration, such as an elongate configuration, to a deployed configuration, such as a curved configuration, of the pericardial anchor 220.

[0143] In other embodiments, as an alternative to weaving the pericardial anchor suture 280 through the plurality of anchor holes 232, the pericardial anchor suture 280 can be otherwise incorporated into the skirt 230, such as by being integrated into the skirt 230 itself or by being fixedly attached or slidably received within a portion of the skirt 230. In some examples, the skirt 230 can include a tunnel or channel that slidably receives the pericardial anchor suture 280.

[0144] In other embodiments, as an alternative to the wire frame 222, a biasing element can be integrated or incorporated into the skirt 230. The biasing element can be operable to bias the skirt 230 into a curved configuration. According to an embodiment, the biasing element can be a densified, embossed, or treated portion of the skirt 230 that is operable to have a bias to transition the pericardial anchor 220 from a pre-deployed configuration to a deployed configuration, such as from an elongated configuration to a curved configuration.

[0145] The pericardial anchor 220 can be maintained in the flat configuration against the bias of the wire frame 222 in the pre-deployed configuration by applying tension to the suture proximal end 317 of the pericardial anchor suture 280 and / or the suture distal end 315 of the pericardial anchor suture 280 extending through the skirt 230, as shown. The pericardial anchor suture 280 can be operable to be tensioned when the wire frame 222 is in the deployed configuration to collapse the skirt 230 into a curvilinear shape, a disc shape, or a loop shape. The pericardial anchor suture 280 can 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. Figure 18

[0146] In some configurations, when the wire frame 222 is in the curved configuration in the deployed configuration, the wire frame 222 can be biased to form a helix. This bias toward a helix can advantageously prevent the wire frame 222 from tangling with itself, other components of the anchor system, or the implantation region. The helical configuration can assist in allowing the pericardial anchor 220 to transition to a coiled configuration. In some configurations, the wire frame 222 has a bias to conform to the pericardial anchor 220 to define a substantially flat disc when in the deployed configuration.

[0147] In other embodiments, as an alternative to the wire frame 222, a biasing element can be integrated or incorporated into the skirt 230. The biasing element can be operable to bias the skirt 230 into a curved configuration. According to an embodiment, the biasing element can be a densified, embossed, or treated portion of the skirt 230 that is operable to have a bias to transition the pericardial anchor 220 from a pre-deployed configuration to a deployed configuration, such as from an elongated configuration to a curved configuration. Figure 19 and 20 ​Instead of the coiled configuration shown, the pericardial anchor 220 can be transformed from a pre-deployment configuration, such as an elongated configuration, suitable for use within a catheter, to a deployed configuration, such as a T-shaped, looped, coiled, bent, compressed, bundled, or packed configuration, in a variety of ways. For example, the pericardial anchor 220 can begin to bend or coil from a free end of the pericardial anchor 220 to initiate a deployed shape, such as a disc shape. The free end can be a distal end of the pericardial anchor 220, which can be a distal termination of both the pericardial anchor 220 and the pericardial anchor system 200. The coiling that can occur can be partial to form a partial disc shape, complete to form a complete disc shape, overlapping to form a complete disc shape. The disc shape can have a low profile to not significantly abut against the visceral pericardium or otherwise significantly interfere with the pericardium. The disc shape can be sized to be operable to prevent the pericardial anchor 220 from being pulled through the perforation or passageway in the myocardium from the delivery subsystem 400 or the pericardial anchor suture 280. The disc shape can be sized to be operable to non-traumatically distribute forces acting on the pericardial anchor 220 and the surrounding tissue abutting thereon caused by tension on the rest of the pericardial anchor system 200. According to other embodiments, the shape of the anchor can define other shapes, such as, but not limited to, a square, a cross, and a diamond. The wire frame 222 of the pericardial anchor 220 can be operable to straighten and return to a low profile, small profile, high surface area shape, which facilitates delivery and deployment of the pericardial anchor 220. The pericardial anchor 220 defining a surface area within the disc shape also facilitates tissue ingrowth and / or distributes loads on the pericardial anchor system 200 over a larger area of the surface of the heart.

[0148] In some embodiments, the pericardial anchor 220 can be bundled or packed to achieve a deployed configuration. For example, the pericardial anchor 220 in an elongated configuration can be folded, compressed, bundled, crimped, or packed to form a deployed configuration. Transmyocardial Wiper

[0149] The pericardial anchor system 200 can include a transmyocardial wiper 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 various embodiments of the transmyocardial wiper disclosed therein. The transmyocardial wiper 240 can be tubular, spherical, rectangular, etc. The transmyocardial wiper 240 can be used to extend the surface area of the wiper suture 300.

[0150] Figure 22An example embodiment of a transmyocardial swab 240 is shown. The transmyocardial swab 240 may include a pericardial anchor suture 280, a swab suture 300, a compression element 310, and a plurality of swab orifices 320 along the transmyocardial swab 240. In some embodiments, the pericardial anchor suture 280 may be tensioned to collapse the pericardial anchor 220. In some embodiments, the swab suture 300 may be tensioned to tighten the transmyocardial swab 240. As described below, the compression element 310 may be integrated with the swab suture 300 and may be used to change the transmyocardial swab 240 from a pre-tightened configuration to a tightened configuration. In some embodiments, the compression element 310 may be integrated with a first end 370 of the swab suture 300. Figure 22 As shown, the transmyocardial swab 240 may have a pre-tightened configuration. The transmyocardial swab 240 may be in a pre-tightened configuration before tension is applied to the swab suture 300. In some embodiments, the transmyocardial swab 240 may form a tightened configuration when tension is applied to the second end 380 of the swab suture 300, as further explained below.

[0151] like Figure 22 As shown, in some embodiments, the swab suture 300 may extend through the transmyocardial swab 240. The transmyocardial swab 240 may include a plurality of swab apertures 320. The swab suture 300 may be braided through the plurality of swab apertures 320. The plurality of swab apertures 320 may be of various sizes. The distance between any two apertures in the plurality of swab apertures 320 may vary. In some embodiments, the distance between at least two swab apertures in the plurality of swab apertures 320 located at the proximal end 350 of the transmyocardial swab 240 may be less than the distance between at least two swab apertures in the plurality of swab apertures 320 located at the middle 245 of the transmyocardial swab 240. In some embodiments, the plurality of swab 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 may include at least one needle puncture, and the second set of apertures may include at least one biopsy aperture. The first set of apertures 330 and the second set of apertures 340 may be located at the distal end 360 of the transmyocardial swab 240. The first set of holes 330 and the second set of holes 340 can receive swab suture 300 to be braided through the plurality of swab holes 320. In some embodiments, the first set of holes 330 and the second set of holes 340 can respectively receive a first end 370 and a second end 380 of the swab suture 300. In some embodiments, the first set of holes 330 can be small enough or have a sufficiently small size to prevent the compression element 310 integrated with the first end 370 of the swab suture 300 from entering and / or passing through the first set of holes 330. For example, the first set of holes 330 can be a slit or a small hole smaller than the compression element 310.

[0152] In some embodiments, the distance between the first set of holes 330 and the second set of holes 340 can be between approximately 1 mm and 5 mm. In another embodiment, the distance between the first set of holes 330 and the second set of holes 340 can be approximately 3 mm. The distance between the first set of holes 330 and the second set of holes 340 can be long enough to help ensure that the compression element 310 integrated with the first end 370 of the swab suture 300 does not interact with the suture lock 270. In some embodiments, the first set of holes 330 can allow the compression element 310 to remain close to the distal end 360 of the myocardial swab 240 in both the pre-tightening configuration and the tightening configuration of the myocardial swab 240. In other words, the first set of holes 330 is sized to prevent the compression element 310 from entering and / or passing through the first set of holes 330 before, during, and after the formation of the tightening configuration of the myocardial swab 240.

[0153] Figure 23 yes Figure 22 A detailed view of the first set of holes 330 through the myocardial swab 240 in the pre-tightening structure shown. (See attached image.) Figure 23 As shown, the first set of holes 330 is defined to be small enough to prevent the compression element 310 from entering and / or passing through the first set of holes 330. Figure 23 As further shown and described above, the compression element 310 is located between the first set of holes 330 and the anchoring recess 260. In some embodiments, the compression element 310 is operable to engage the transmyocardial swab 240 and apply pressure to the surface of the transmyocardial swab 240, thereby tightening or collapsing the transmyocardial swab 240, while the compression element 310 remains between the first set of holes 330 and the anchoring recess 260 during tightening or collapse of the transmyocardial swab 240. Compression of the transmyocardial swab 240 in response to the compression element 310 applying pressure to the transmyocardial swab 240 by tensioning the swab suture 300 will be further described below.

[0154] Figure 24 It is in a tightening structure Figure 22 Detailed view of the first set of holes 330 of the percutaneous myocardial swab 240. (See attached image.) Figure 24 As shown, the first set of orifices 330 is small enough to prevent the compression element 310 from entering the first set of orifices 330 when the compression element 310 applies pressure to the transmyocardial swab 240 to tighten the transmyocardial swab 240 by the tension applied to the swab suture 300. Figure 24Further shown, the compression element 310 applies pressure to the surface of the transmyocardial swab 240, which is operable to compress, fold, crumple, bunch, etc. the transmyocardial swab 240. For example, in one embodiment, the compression element 310 is operable to apply pressure to the transmyocardial swab 240 by compressing, folding, crumpling, or otherwise, the transmyocardial swab 240, thereby affecting a reduction in the effective length or profile shape of the transmyocardial swab 240, which can result in a reduction in the distance between the pericardial anchor 220 and the anchor socket 260. In some embodiments, the pressure applied to the transmyocardial swab 240 by the compression element will reduce the distance between the pericardial anchor 220 and the anchor socket 260. As Figure 24 Further shown and described above, the compression element 310 is positioned between the first set of holes 330 and the transmyocardial swab 240 as the transmyocardial swab 240 transitions from the elongated configuration to the cinched configuration.

[0155] Figures 25A-25B An example embodiment of a swab suture 300 path through the transmyocardial swab 240 is shown. As Figures 25A-25B shown, the swab suture 300 can be woven through the plurality of swab holes 320 defined by the transmyocardial swab 240 as Figure 22 shown. In some embodiments, a first end 370 of the swab suture 300 is woven through the plurality of swab holes 320 from a distal end 360 of the transmyocardial swab 240 to a proximal end 350 of the transmyocardial swab 240. The swab suture 300 is woven back through the same or different plurality of swab holes 320 from the proximal end 350 of the transmyocardial swab 240 to the distal end 360 of the transmyocardial swab 240. This results in the first end 370 of the swab suture 300 and a second end 380 of the swab suture 300 extending from the distal end 360 of the transmyocardial swab 240. In some embodiments, the swab suture 300 can be woven from the proximal end 250 of the transmyocardial swab 240 back through the plurality of swab holes 320 to the distal end 360 of the transmyocardial swab 240, the plurality of swab holes 320 being the same as the plurality of swab holes 320 through which the swab suture 300 is woven from the distal end 360 of the transmyocardial swab 240 back to the proximal end 350 of the transmyocardial swab 240. This can allow the transmyocardial swab 240 to accordion fold or uniformly cinch. In some embodiments, the swab suture 300 can be woven from the proximal end 250 of the transmyocardial swab 240 back through the plurality of swab holes 320 to the distal end 360 of the transmyocardial swab 240, the plurality of swab holes 320 being different than the plurality of swab holes 320 through which the swab suture 300 is woven from the distal end 360 of the transmyocardial swab 240 back to the proximal end 350 of the transmyocardial swab 240. This can allow the transmyocardial swab 240 to bunch or cinch non-uniformly.

[0156] In some embodiments, the distal end 360 of the transmyocardial swab 240 can be connected to the anchor socket 260. In some embodiments, the proximal end 350 of the transmyocardial swab 240 can be connected to the pericardial anchor 220. For example, the swab suture 300 can enter one of the plurality of swab holes 320 and exit the transmyocardial swab 240 through a subsequent one of the plurality of swab holes 320. In some embodiments, after the swab suture 300 is woven through the plurality of swab holes 320 from the distal end 360 of the transmyocardial swab 240 to the proximal end 350 of the transmyocardial swab 240, the swab suture 300 can be woven through the plurality of swab holes 320 from the proximal end 350 of the transmyocardial swab 240 to the distal end 360 of the transmyocardial swab 240. In some embodiments, the swab suture 300 can be guided through the same plurality of swab holes 320 in a distal-to-proximal direction and in a proximal-to-distal direction.

[0157] One of the more proximal or most proximal holes 355 of the plurality of swab holes 320 can be a hole where the swab suture changes direction to weave through the plurality of swab holes 320 in a direction opposite the previous weaving direction. The more proximal or most proximal hole 355 of the plurality of swab holes 320 can be the hole of the plurality of swab holes 320 that is farthest from the anchor socket 260. In other words, the more proximal or most proximal hole 355 of the plurality of swab holes 320 can be located on the proximal end 350 of the transmyocardial swab 240. In other words, the more proximal or most proximal hole 355 of the plurality of swab holes 320 can be closest to the pericardial anchor 220.

[0158] As Figures 25A-25B As further shown, the distance between each two of the plurality of swab holes 320 located on the proximal portion of the transmyocardial swab 240 can be shorter than the distance between each two of the plurality of swab holes 320 located on the middle portion of the transmyocardial swab 240. The shorter distance between each two of the plurality of swab holes 320 at the proximal portion of the transmyocardial swab 240 can allow the swabs to bunch up within the endocardium to substantially seal the tissue when the transmyocardial swab 240 is transitioned from the pre-tightened configuration to the tightened configuration. In contrast, the greater distance between each two of the plurality of swab holes 320 located on the middle portion of the transmyocardial swab 240 can allow the transmyocardial swab 240 to fold to substantially lay flat against the endocardium when the transmyocardial swab 240 is transitioned from the pre-tightened configuration to the tightened configuration. It can be appreciated that the distance between the swab holes 320 affects the folding or crumpling configuration of the transmyocardial swab 240 suitable for a particular use, and that the distance can vary along the length of the transmyocardial swab 240. It can also be appreciated that the selection of swab holes 320 traversed by the swab suture 300 will affect the folding or crumpling configuration of the transmyocardial swab 240 suitable for a particular use and / or the tension changes that will be perceived by the user, and that the selection of traversing can vary along the length of the transmyocardial swab 240.

[0159] In some embodiments, when the pledget suture 300 is woven through the plurality of pledget holes 320 in two directions, the first end 370 of the pledget suture 300 and the second end 380 of the pledget suture 300 can 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 be coupled to a compression element 310. The compression element 310 is held between the first set of holes 330 and the anchor socket 260. The second end 380 of the pledget suture 300 can be a tail 385 as shown that extends through the anchor socket 260 to which tension can be applied to operatively cinch the transmyocardial pledget 240. In some embodiments, the compression element 310 does not engage with the suture lock. In some embodiments, the second end 380 of the pledget suture 300 extends through the anchor socket 260. Figure 22

[0160] As described above, the pledget suture 300 can be guided through the transmyocardial pledget 240 prior to loading the transmyocardial pledget 240 onto a delivery system. The plurality of pledget holes 320 can be arranged in a random arrangement or in a patterned arrangement. For example, the pledget holes 320 can be arranged in, for example, but not limited to, a collinear arrangement, a zigzag arrangement, and the like, as suitable for a particular use, for example, to affect a particular dimensional change of the transmyocardial pledget 240 when in a compressed configuration. The pledget suture 300 can be made of any suitable biocompatible material, for example, but not limited to, a fluoropolymer fiber.

[0161] Figure 26 An example embodiment of a transmyocardial pledget 240 in a cinched configuration is shown. The transmyocardial pledget 240 can be transitioned from a pre-cinched configuration of the transmyocardial pledget 240 to a cinched configuration by applying tension to the pledget suture 300 and the pericardial anchor 220. In some embodiments, the pledget suture 300 can allow the transmyocardial pledget 240 to transition from a flatter configuration or pre-cinched configuration as shown in Figure 22 to a cinched configuration as shown in Figure 26 For example, tension applied to the second end 380 of the pledget suture 300 can allow the compression element 310 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 the transmyocardial pledget 240 in a concertina-like manner. For example, the compression element 310 applies pressure to the transmyocardial pledget 240 by compressing, folding, crumpling, or otherwise compressing the transmyocardial pledget 240 to reduce the effective length or profile shape of the transmyocardial pledget 240. This reduces the distance between the pericardial anchor 220 and the anchor socket 260. The transmyocardial pledget 240 can contain pleats to facilitate folding during compression of the transmyocardial pledget 240.

[0162] ​The transmyocardial swab 240 can transition from a more flat pre-tensioned configuration to a curved or tensioned configuration before or after the pericardial anchor 220 is fully deployed. For example, the pericardial anchor 220 can be crimped or collapsed against the epicardium by engagement of the pericardial anchor suture 280 with tension applied to the swab suture 300 before the transmyocardial swab 240 is transitioned to a curved or tensioned configuration by engagement of the swab suture 300 with tension applied. Similarly, in another embodiment, the T-bar can be deployed against the epicardium before the transmyocardial swab 240 is transitioned to a compressed configuration by engagement of the swab suture 300 with tension applied, then the pericardial anchor 220 is crimped or collapsed against the epicardium by engagement of the pericardial anchor suture 280 with tension applied. In this way, the swab suture 300 and the pericardial anchor suture 280 can be operated independently. In other words, applying tension to the swab 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 swab 240.

[0163] The transmyocardial swab 240 can include a membrane comprising one or more layers. The membrane can be a fluoropolymer, which can have tissue ingrowth properties. The membrane of the transmyocardial swab 240 can have a tubular structure. The transmyocardial swab 240 can include a plurality of swab holes 320 positioned along the length of the transmyocardial swab 240. The swab suture 300 can be woven through or integrated in the membrane of the transmyocardial swab 240, such as but not limited to between the membrane layers forming a composite laminate. As shown in FIGS. 3A and 3B, the swab suture 300 can be woven through a plurality of swab holes 320 through the membrane of the transmyocardial swab 240. The swab suture 300 can allow the transmyocardial swab 240 to transition from a more flat configuration, such as shown in FIG. 3A, to a curved configuration, such as shown in FIG. 3B. For example, tensioning or retraction of the swab suture 300 can compress or fold the material of the transmyocardial swab 240 in a concertina-like manner. The transmyocardial swab 240 can include pleats to facilitate folding during deployment of the transmyocardial swab 240. The transmyocardial swab 240 can transition from a more flat configuration to a curved configuration before or after the pericardial anchor is deployed. Figure 18 and 19 As shown, the swab suture 300 can be woven through a plurality of swab holes 320 through the membrane of the transmyocardial swab 240. The swab suture 300 can allow the transmyocardial swab 240 to transition from a more flat configuration, such as shown in FIG. 3A, to a curved configuration, such as shown in FIG. 3B. For example, tensioning or retraction of the swab suture 300 can compress or fold the material of the transmyocardial swab 240 in a concertina-like manner. The transmyocardial swab 240 can include pleats to facilitate folding during deployment of the transmyocardial swab 240. The transmyocardial swab 240 can transition from a more flat configuration to a curved configuration before or after the pericardial anchor is deployed. Figure 18 and Figure 20 As shown, the swab suture 300 can be woven through a plurality of swab holes 320 through the membrane of the transmyocardial swab 240. The swab suture 300 can allow the transmyocardial swab 240 to transition from a more flat configuration, such as shown in FIG. 3A, to a curved configuration, such as shown in FIG. 3B. For example, tensioning or retraction of the swab suture 300 can compress or fold the material of the transmyocardial swab 240 in a concertina-like manner. The transmyocardial swab 240 can include pleats to facilitate folding during deployment of the transmyocardial swab 240. The transmyocardial swab 240 can transition from a more flat configuration to a curved configuration before or after the pericardial anchor is deployed.

[0164] The transmyocardial swab 240 can also include a compression element 310 that can be located at the first end 370 of the swab suture 300. The compression element 310 can be used to assist in cinching the transmyocardial swab 240 or transitioning the transmyocardial swab 240 from a pre-cinched configuration to a cinched configuration. The compression element 310 can be a separate element coupled to the first end 370 of the swab suture 300 or an integral element defined by the first end 370 of the swab suture 300. In some embodiments, for example, the compression element 310 can include a knot. In other embodiments, for example, the compression element 310 is a loop coupled to the first end 370 of the swab suture 300. In some embodiments, the suture second end 380 is threaded through the compression element 310 and slidingly received therein to allow for sliding engagement therebetween. Tension applied to the second end 380 of the swab suture 300 can be operable to translate the compression element 310 along the second end 380 of the swab suture 300, thereby applying pressure to the surface of the transmyocardial swab 240 through the pushing engagement of the compression element 310 against the transmyocardial swab 240. This results in the transmyocardial swab 240 being cinched, folded, bunched, and / or reduced in effective length and expanded in circumference (i.e., transverse to the longitudinal axis of the transmyocardial swab 240), thereby occluding, sealing, or filling a space or passageway within the myocardium through which it travels.

[0165] In other embodiments, the suture second end 380 is not threaded through the compression element 310. Tension applied to the second end 380 of the swab suture 300 can be operable to translate the compression element 310 to the first set of holes 330, thereby applying pressure to the surface of the transmyocardial swab 240 through the pushing engagement of the compression element 310 against the transmyocardial swab 240. This results in the transmyocardial swab 240 being cinched, folded, bunched, and / or reduced in effective length and expanded in circumference (i.e., transverse to the longitudinal axis of the transmyocardial swab 240), thereby occluding, sealing, or filling a space or passageway within the myocardium through which it travels.

[0166] The compression element 310 can allow the transmyocardial swab 240 to be cinched from the distal end 360 of the transmyocardial swab 240 to the proximal end 350 of the transmyocardial swab 240. Pressure applied to the compression element 310 can cause the transmyocardial swab 240 to collapse. For example, the compression element 310 can be translated to the first set of holes 330, which can allow the compression element 310 to apply pressure to the surface of the transmyocardial swab 240. In some embodiments, tension can be applied to the second end 380 of the swab suture 300 in a second direction 390. This affects the translation of the compression element 310 along the swab suture 300 and the application of pressure to the surface of the transmyocardial swab 240, which can be operable to transition the transmyocardial swab 240 to a cinched configuration. The second direction 390 can be a direction away from the pericardial anchor 220 and / or the T-bar 290.

[0167] In some embodiments, translation of the compression element 310 can lock the trans myocardial swab 240 in a collapsed or cinched configuration. The trans myocardial swab 240 can remain locked in the cinched configuration by, for example, but not limited to, a resistance to motion or friction between the swab suture 300 and the plurality of swab holes 320. In some embodiments, a predetermined resistance between the swab suture 300 and the plurality of swab holes 320 can allow the trans myocardial swab 240 to remain in the cinched configuration as shown. Figure 24 In some embodiments, a second predetermined resistance between the compression element 310 and the first end 370 of the swab suture 300 can also allow the trans myocardial swab 240 to remain in the cinched configuration as shown. Figure 24 In some embodiments, a combination of the predetermined resistance and the second predetermined resistance can allow the trans myocardial swab 240 to remain in the cinched configuration as shown. Figure 24 In some embodiments, the compression element 310 can translate to a new position or return to its original position, which can not affect the configuration of the trans myocardial swab 240. This can allow the swab suture to be untensioned or have minimal tension applied to the swab suture 300 when the trans myocardial swab 240 is in the cinched configuration. In other words, slack in the swab suture 300 can be provided when the trans myocardial swab 240 is in the collapsed configuration and remains in the collapsed configuration. Tension subsequently applied to the swab suture 300 can be independent of or have minimal effect on the configuration of the trans myocardial swab 240. This can allow the pericardial anchor suture 280 and the swab suture 300 to operate independently of one another.

[0168] In other embodiments, the swab suture 300 can remain under a predetermined resistance when the trans myocardial swab 240 is in the collapsed configuration. In some embodiments, a predetermined tension can be applied to the second end 380 of the swab suture 300, which can cinch the trans myocardial swab 240. This can create a predetermined resistance between the swab suture 300 and the trans myocardial swab 240 that allows the trans myocardial swab 240 to remain in the cinched configuration. In some embodiments, the predetermined tension can be between about 0.5 N - 3 N. In some embodiments, the predetermined tension can be between about 1 N - 2 N.

[0169] In some embodiments, translation of the compression element 310 can operate to apply pressure to the surface of the trans myocardial swab 240, which helps to hold or maintain the trans myocardial swab 240 in the cinched or collapsed configuration. This allows the trans myocardial swab 240 to have an adjustable configuration. In this manner, the trans myocardial swab 240 can not be locked in a single configuration, but can be adjustable throughout the entire mitral valve repair procedure. For example, the configuration of the trans myocardial swab 240 can be adjusted at the time of, prior to, or after locking of the leaflet anchor sutures as described below.

[0170] Figure 27A An example embodiment of the swab suture 300 is shown. As Figure 27AAs shown, the swab suture 300 defines the compression element 310 as an integral part of the swab suture 300 in the form of a defined loop secured by a knot. The compression element 310 is located at a first end of the swab suture 300. The compression element 310 may be a knot, or a non-slip knot, or a non-slip loop knot, which can be used to apply pressure to the surface of the transmyocardial swab 240 to change the transmyocardial swab 240 from a pre-tightened configuration to a tightened configuration. The compression element 310 may be located at a fixed length at the first end 370 of the swab suture 300. The second end 380 of the swab suture 300 may be kept extended or elongated to allow tension to be applied to the second end 380 of the swab suture 300. In some embodiments, tension may be applied to the second end 380 of the swab suture 300, which is operable to translate the compression element 310 along the swab suture 300 and apply pressure to the surface of the transmyocardial swab 240. In some embodiments, where the second end 380 of the swab suture 300 is slidably received by the compression element 310, the compression element 310 may not tighten around the second end 380 of the swab suture 300 when tension is applied to the second end 380, changing the length of the first end 370 of the swab suture 300, and / or changing the diameter when the compression element 310 is formed as a loop. In some embodiments, the tension applied to the second end 380 of the swab suture 300 may be applied along a second direction 405. For example, the second direction 405 may be a direction away from the pericardial anchor. This allows the compression element 310 to translate along the swab suture 300 in a first direction 410 opposite to the second direction 405. In some embodiments, when tension is applied to the second end 380 of the swab suture 300 along the second direction 405, the compression element 310 translates along the swab suture 300 in the first direction 410. The first direction 410 may be a direction toward the pericardial anchor.

[0171] Figure 27B An example embodiment of the compression element 310 is shown. For example... Figure 27B As shown, the compression element 310 may be an anti-slip loop. The compression element 310 may be located at a fixed length at the first end 370 of the swab suture 300. In some embodiments, the compression element 310 may include a knot 312 and a loop 314. In this way, the loop 314 of the compression element 310 may be locked or secured, which may allow the first end 370 of the swab suture 300 integrated with the compression element 310 to move substantially freely, unstressed or unsecured, along the second end 380 of the swab suture 300 when the swab suture 300 is slidably received. In some embodiments, the knot 312 may be a washer, an O-ring, etc. In some embodiments, the knot 312 may be large enough to prevent the compression element 310 from entering the first hole of the first set of holes 330.

[0172] Figure 28An example embodiment of a pericardial anchoring system 200 in a laid flat configuration is shown. The pericardial anchoring system 200 can include a transmyocardial pledget 240 and a pericardial anchor 220. In some embodiments, the pericardial anchor 220 and the transmyocardial pledget 240 can be perpendicular to each other. A proximal end of the transmyocardial pledget 240 can be connected to a proximal end of the pericardial anchor 220 in a perpendicular arrangement. In some embodiments, the pericardial anchoring system 200 can also include a pericardial anchor suture 280 and a pledget suture 300. The pledget suture 300 can be woven through a plurality of pledget holes 320 located on the transmyocardial pledget 240. The plurality of pledget holes 320 can be arranged in a random arrangement, a straight arrangement, a patterned arrangement, etc. In some embodiments, the plurality of pledget holes can be evenly spaced from each other. In other embodiments, the plurality of pledget holes 320 can each have a different spacing from each other. In some embodiments, a distance between at least some of the plurality of pledget holes 320 located on a proximal portion of the transmyocardial pledget 240 can be smaller than a distance between at least some of the plurality of pledget holes 320 located on a middle portion of the transmyocardial pledget 240. In some embodiments, a distance between at least some of the plurality of pledget holes located on a distal portion of the transmyocardial pledget 240 can be smaller than a distance between at least some of the plurality of pledget holes 320 located on the middle portion of the pledget 240. For example, a first distance between a first hole of the plurality of pledget holes and a second hole of the plurality of holes can be smaller than a second distance between the second hole of the plurality of holes and a third hole. In some embodiments, the arrangement and / or placement of the plurality of pledget holes 320 can determine how the transmyocardial pledget 240 transitions from a pre-tensioned configuration to a tensioned configuration. For example, the plurality of pledget holes located on the proximal portion of the transmyocardial pledget 240 can allow the transmyocardial pledget 240 to bunch up in a compact manner. In another example, the plurality of pledget holes located on the middle portion of the transmyocardial pledget 240 can allow the transmyocardial pledget 240 to fold or uniformly fold.

[0173] The pledget suture 300 can be woven through some or each of the plurality of pledget holes 320. In some embodiments, the pledget suture 300 can be woven through some or each of the plurality of pledget holes 320 more than once. For example, the pledget suture 300 can be woven from the distal end 360 of the transmyocardial pledget 240 through some or each of the plurality of pledget holes 320 to the proximal end 350 of the transmyocardial pledget 240. Once the pledget suture 300 is woven through one of the pledget holes proximal or closest to the proximal end 350 of the transmyocardial pledget 240, the pledget suture 300 can be reversed and woven from the proximal end 350 of the transmyocardial pledget 240 through some or each of the plurality of pledget holes 320 to the distal end 360 of the transmyocardial pledget 240. According to one embodiment, wherein the pledget suture 300 is woven from the distal end 360 of the transmyocardial pledget 240 through each of the plurality of pledget holes 320 in sequence to the proximal end 350 of the transmyocardial pledget 240, and reversed and woven back from the proximal end 350 of the transmyocardial pledget 240 through the same respective plurality of pledget holes 320 to the distal end 360 of the transmyocardial pledget 240, this will result in the transmyocardial pledget 240 being compressed in a concertina-like manner, which can provide a predetermined profile to affect a sealing engagement with an endocardial or myocardial passageway. According to another embodiment, wherein the pledget suture 300 is woven from the distal end 360 of the transmyocardial pledget 240 through each of the plurality of pledget holes 320 in sequence to the proximal end 350 of the transmyocardial pledget 240, and reversed and woven back from the proximal end 350 of the transmyocardial pledget 240 through different pledget holes 320 to the distal end 360 of the transmyocardial pledget 240, this will result in the transmyocardial pledget 240 being compressed in a bundled manner that is more disordered relative to a concertina-like manner, which can provide a predetermined profile to affect a sealing engagement with an endocardial or myocardial passageway.

[0174] In some embodiments, the pericardial anchor suture 280 can be woven through some, none, or at least two of the plurality of pledget holes 320. This can allow the pericardial anchor suture 280 connected to the pericardial anchor 220 to be woven through the plurality of anchor holes 232 located on the pericardial anchor. For example, the pericardial anchor suture 280 can be woven through the proximal-most pledget hole 320 of the plurality of pledget holes located on the transmyocardial pledget 240 that is closest to the pericardial anchor. The pericardial anchor suture 280 can then be woven through some or all of the plurality of anchor holes 232 located on the pericardial anchor. This can allow tension to be applied to the pericardial anchor suture 280 to deploy the pericardial anchor 220 as described above, which can not affect the configuration of the transmyocardial pledget 240. In this manner, the pericardial anchor suture 280 and the pledget suture 300 can be operated independently. In some embodiments, the pericardial anchor suture 280 can be woven through a second plurality of holes not shown located on the transmyocardial pledget 240. In some embodiments, the pericardial anchor 220 can be deployed to form, for example, a disc shape. In some embodiments, the pericardial anchor suture 280 can extend beyond the distal end 360 of the transmyocardial pledget 240, which can allow the pericardial anchor suture 280 to be easily tensioned.

[0175] In some embodiments, the pericardial anchor suture 280 can be tensioned prior to the pledget suture 300 being tensioned. For example, the pericardial anchor 220 can be deployed (e.g., formed into a disc shape) prior to the transmyocardial pledget 240 being transitioned from the pre-tightened configuration to the tightened configuration. In other embodiments, the pledget suture 300 can be tensioned prior to the pericardial anchor suture 280 being tensioned. For example, the pledget suture 300 can be transitioned from the pre-tightened configuration to the tightened configuration prior to the pericardial anchor being deployed. In other embodiments, the pericardial anchor suture 280 and the pledget suture 300 can be tensioned simultaneously. For example, the transmyocardial pledget 240 can be transitioned from the pre-tightened configuration to the tightened configuration at the same time or approximately the same time as the pericardial anchor 220 is deployed.

[0176] Figure 29 An isometric view of an example embodiment of a transmyocardial pledget 240 is shown. As Figure 29As shown, the pericardial anchor suture 280 can extend beyond 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 can also extend beyond the distal end of the pledget. In some embodiments, the second end of the pledget suture 300 can be tensioned, which can cause the compression element 310 at the first end 370 of the pledget suture 300 to apply pressure to the surface of the transmyocardial pledget 240. This can cause the transmyocardial pledget 240 to collapse or transition into a cinched configuration. In some embodiments, the transmyocardial pledget 240 will collapse or transition into a cinched configuration when the compression element 310 applies pressure to the surface of the transmyocardial pledget 240. As shown, Figure 29 As shown, the compression element 310 can have a diameter that is larger than at least one of the plurality of pledget holes 320. For example, the compression element 310 can have a diameter that is larger than the first set of holes 330. This can prevent the compression element 310 from entering the plurality of pledget holes 320 and allow the transmyocardial pledget 240 to form a cinched configuration. In some embodiments, the first end 370 of the pledget suture 300 can be cut at the compression element 310. In other embodiments, the second end 380 of the pledget suture 300 can remain an element of the pericardial anchor system.

[0177] Figure 30 A top view of an example embodiment of a transmyocardial pledget 240 is shown. As shown, Figure 30 As shown, the compression element 310 integrated with the pledget suture 300 can have a diameter that is larger than the size of the first set of holes 330. This can prevent the compression element 310 from entering the plurality of pledget holes 320 and allow the transmyocardial pledget 240 to form a cinched configuration.

[0178] Figures 31A-31D An example embodiment of a compression element 310 is shown. As shown, Figures 31A-31D As shown, the compression element 310 can include a compression fit sleeve 420. The compression fit sleeve 420 can be silicone, oPTFE, PTFE, or the like. Figure 31A A top view of a transmyocardial pledget 240 with a compression fit sleeve 420 is shown. Figure 31B A side view of a transmyocardial pledget 240 with a compression fit sleeve 420 is shown. Figure 31C An isometric view of a transmyocardial pledget 240 with a compression fit sleeve 420 is shown. Figure 31D A close-up view of a compression fit sleeve 420 is shown. As shown, Figure 31A As shown, the compression fit sleeve 420 can have a size that is larger than the plurality of pledget holes 320. This can prevent the compression fit sleeve 420 from entering the plurality of pledget holes 320 and allow the transmyocardial pledget 240 to form a cinched configuration. In some embodiments, the pledget suture 300 can be threaded through the compression fit sleeve 420.

[0179] Figures 32A-32D An example embodiment of the compression element 310 is shown. For example... Figures 32A-32D As shown, the compression element 310 may include a micro swab 430. The micro swab 430 may be made of silicone, oPTFE, PTFE, etc. Figure 32A A top view of a transmyocardial swab 240 with a miniature swab 430 is shown. Figure 32B A side view of a swab with a micro-swab is shown. Figure 32C An isometric view of a transmyocardial swab 240 with a miniature swab 430 is shown. Figure 32D An enlarged view of the micro swab 430 is shown. (As shown) Figure 32A As shown, the microswab 430 can be larger than the plurality of swab holes 320. This prevents the microswab 430 from entering the plurality of swab holes 320 and allows the swab to form a tightened structure. In some embodiments, swab sutures 300 can be threaded through the microswab 430. In some embodiments, the microswab 430 can extend when subjected to tension.

[0180] Figures 33A-33D An example embodiment of the arrangement of multiple microswab apertures 440 is shown. The multiple microswab apertures 440 can be arranged randomly or in a pattern. For example, the multiple microswab apertures 440 can be arranged in a zigzag, straight, curved, or diagonal pattern. Figure 33A , 33B As shown in 33C, the multiple microswab apertures 440 can be arranged in a serrated pattern. The multiple microswab apertures 440 can be offset from the center of the microswab 430. The serrated arrangement of the multiple microswab apertures 440 allows the microswab 430 to collapse or tighten in a twisted manner when the swab suture 300 is tensioned. This can provide additional resistance between the microswab 430 and the swab suture 300 before the myocardial swab 240 fully transitions to a tightened configuration. Pericardial anchoring system deployment

[0181] The pericardial anchoring system can be deployed in, for example, repair of a mitral valve leaflet. To deploy the pericardial anchoring system 200, in some embodiments, tension can be applied to the pericardial anchor suture 280 that can be woven through the pericardial anchor 220. This can deploy the pericardial anchor 220. For example, the pericardial anchor suture 280 can deploy into a disc shape. In some embodiments, tension can be applied to the second end 380 of the pledget suture 300. This can allow the compression element 310 to apply pressure to the surface of the transmyocardial pledget 240 in the pre-tightened configuration. This can transition the transmyocardial pledget 240 from the pre-tightened configuration to the tightened configuration. For example, tension can be applied to the second end 380 of the pledget suture 300 in a direction opposite or away from the pericardial anchor 220. Then, the compression element 310 can apply pressure to the surface of the transmyocardial pledget 240 in a direction toward the pericardial anchor 220 to transition the transmyocardial pledget 240 to the tightened configuration. The transmyocardial pledget 240 can be locked in the tightened configuration. This can be due to the predetermined resistance between the pledget suture 300 and the transmyocardial pledget 240 can stabilize or lock the transmyocardial pledget 240 in the tightened configuration. Once the transmyocardial pledget 240 is locked, the compression element 310 can translate to a new position or to its original position without affecting the configuration of the transmyocardial pledget 240. This can allow the pledget suture 300 to relax, remain untensioned, or be applied with minimal tension. Then, the second end 380 of the pledget suture 300 and the pericardial anchor suture 280 can be guided through the suture lock 270 that can be connected to the anchor socket 260 within the transmyocardial pledget 240. In some embodiments, the transmyocardial pledget 240 can be transitioned from the pre-tightened configuration to the tightened configuration prior to the deployment of the pericardial anchor 220. Suture lock

[0182] The pericardial anchoring system 200 can also include an anchor socket 260 that 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 entirety of which is incorporated herein by reference, and 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 herein by reference, and various embodiments of suture locks or sockets disclosed therein. The suture lock 270 can be used to secure each of the pericardial anchor suture 280 and the leaflet anchor suture 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 suture 310A. Once the length is optimized to achieve sufficient tension for mitral chord repair, the suture lock 270 can be locked to secure the length of each of the pericardial anchor suture 280 and the leaflet anchor suture 310A. Socket

[0183] As used herein, the term “socket” includes and can be used interchangeably with any of the following terms: cover, container, shroud, coupling, restraint, retaining member, etc. According to 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 a pre-deployed configuration on a 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 that the suture lock 270 is completely covered by the anchor socket 260. The anchor socket 260 can be a retaining member that restrains the motion of the suture lock relative to the rest of the pericardial anchoring system 200 and the motion of the suture relative to the suture lock 270. The anchor socket 260 can also be referred to as a suture lock guide, socket, or sleeve. The anchor socket 260 can reduce the abrasion on each of the pericardial anchor suture 280 and the leaflet anchor suture 310A, which can guarantee the tension in the suture. The anchor socket 260 can couple the pericardial anchoring system 200 and the suture lock. Deployed anchoring system

[0184] Figure 34is an example of a pericardial anchoring system 200 deployed and partially implanted in place in a ventricle. As shown, a pericardial anchor 220 in a looped configuration is positioned in the pericardial space. The pericardial anchor 220 can anchor the pericardial anchoring system 200 and act as a mechanical interface for anchoring the pericardial anchoring system 200. The pericardial anchor 220 can also be used to seal one end of a myocardial perforation. A transmyocardial pledget 240 extends from the pericardial anchor 220 with a portion extending through the heart wall 41 and a portion folded against the endocardial layer of the heart wall 41. A suture lock 270 positioned within an anchor socket 260 can be positioned against the folded portion of the transmyocardial pledget 240. The suture lock 270 surrounded by the anchor socket 260 can drive the anchor socket 260 to the endocardial surface, which can also help seal the perforation in the endocardial surface by the folded portion of the transmyocardial pledget 240. A 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 track 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 increases the bulk of the pericardial anchor suture 280, which the pericardial anchor suture itself can be prone to cut or slice through the myocardium by exerting tension or load. The transmyocardial pledget 240 prevents the pericardial anchor suture 280 from migrating within the myocardium. The transmyocardial pledget 240 can create a myocardial seal by plugging a passageway or perforation through the heart wall 41 and by folding over to seal the perforation on the endocardial surface. For example, the transmyocardial pledget 240 can cinch or collapse, which can cause a T-bar 290 to engage with the epicardium. This can seal the passageway or perforation of the epicardium during deployment of the pericardial anchoring system 200 through the heart wall. In another example, the transmyocardial pledget 240 can cinch or collapse, which can cause the transmyocardial pledget 240 to bunch or pack against the endocardium during deployment of the pericardial anchoring system 200 through the heart wall. In some embodiments, the transmyocardial pledget 240 can lie flush against the endocardium when in a cinched configuration during deployment of the pericardial anchoring system 200 through the heart wall. This can seal the passageway or perforation of the endocardium. In another example, the transmyocardial pledget 240 can cinch or collapse, which can cause the circumference of the transmyocardial pledget 240 to expand laterally or longitudinally during deployment of the pericardial anchoring system 200 through the heart wall. This can seal the passageway or perforation through the myocardium. In another example, any combination of the modes of sealing the perforation or passageway of the heart wall during deployment of the pericardial anchoring system 200 through the heart wall as described above can be envisioned.

[0185] The pledget hole distance, or the distance between one and the next of the plurality of pledget holes, can affect how the transmyocardial pledget is folded when in the cinched configuration. For example, the pledget distance between at least two of the plurality of pledget holes can be greater than a maximum lateral dimension of the transmyocardial pledget 240 operable to fold the transmyocardial pledget 240 when in the cinched configuration to an enlarged or greater dimension in the lateral direction relative to a maximum lateral 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 can be greater than or more than a shortened dimension in the lateral direction of the transmyocardial pledget when in the elongated configuration or the cinched configuration. Similarly, for example, the pledget hole distance between at least two of the plurality of pledget holes is greater than twice a maximum lateral dimension of the transmyocardial pledget operable to fold the transmyocardial pledget 240 when in the cinched configuration to a greater dimension in the lateral direction relative to a maximum lateral 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 can allow the transmyocardial pledget 240 to be folded in half. Further, for example, the plurality of pledget holes 320 can not be co-linearly positioned along the longitudinal direction 247 of the transmyocardial pledget 240 as shown, the transmyocardial pledget 240 operable to fold the transmyocardial pledget 240 when in the cinched configuration to a greater dimension in the lateral direction relative to a maximum lateral 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. Figure 28

[0186] The suture lock 270 can also capture a leaflet anchor suture 310A. The leaflet anchor suture 310A can extend between a leaflet anchor 300A implanted in a mitral valve leaflet 9 and the suture lock 270 to repair a mitral valve chord. Leaflet anchor implantation

[0187] Figure 35A is an example of a leaflet anchor implanted in a valve leaflet and a leaflet anchor suture 310A extending between the leaflet anchor 300A and at least a pericardial anchoring system 200 implanted in a ventricular wall according to an embodiment. As shown, the pericardial anchoring system 200 is implanted in a ventricular wall such that the anchor socket 260 is positioned against an endocardial surface of the heart wall 41. The leaflet anchor 300A can be an anchor in which 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 to the leaflet anchor 300A. The leaflet anchor 300A can be an anchor positioned within a mitral valve leaflet 9. The leaflet anchor 300A can be a pledget.​

[0188] Figure 35B is a cross-sectional view of a ventricular wall with an implanted ventricular anchor system. As shown, a pericardial anchor 220 can be positioned within the pericardial space 10. A transmyocardial pledget 240 can extend from the pericardial anchor 220 and through a perforation of the endocardium, myocardium, and epicardium. The transmyocardial pledget 240 can also be folded against the endocardial surface of the heart wall 41. An anchor socket 260 can be positioned against the endocardium of the heart wall 41.

[0189] Figure 35C is a view of a pericardial anchor 220 implanted within the pericardial space. leaflet anchor system

[0190] According to an embodiment, the pericardial anchor system 200 can be used to control the motion of the mitral valve leaflets by coupling the pericardial anchor suture 280 to one or more leaflet anchor sutures 310A, also referred to as tethers, which are themselves coupled to the mitral valve leaflets 9. After the pericardial anchor 220 and transmyocardial pledget 240 are delivered to the target location, the pericardial anchor suture 280 can be coupled to the suture lock and to the mitral valve leaflets 9 by using the leaflet anchor system 510. The anchor system 510 includes a leaflet anchor 300A and a leaflet anchor suture 310A, which is operable to pass through the mitral valve leaflets 9 and couple to the mitral valve leaflets. In some embodiments, the leaflet anchor can be delivered to the mitral valve prior to delivering the pericardial anchor system. In some embodiments, the leaflet anchor suture 310A can be coupled to the mitral valve leaflets 9 prior to the leaflet anchor suture 310A being coupled to the pericardial anchor suture 280 and / or pledget suture.

Claims

1. A pericardial anchoring system comprising: a pericardial anchor; a transmyocardial wiper extending from a proximal end of the pericardial anchor; and a transmyocardial wiper suture coupled with the transmyocardial wiper and operable to transition the transmyocardial wiper from an elongated configuration to a cinched configuration upon application of tension to an end of the transmyocardial wiper suture, thereby defining a reduced dimension in a longitudinal direction. the transmyocardial wiper suture is operable to transition the transmyocardial wiper from an elongated configuration to a cinched configuration upon application of tension to an end of the transmyocardial wiper suture, thereby defining an enlarged dimension transverse to the longitudinal direction.

2. The pericardial anchoring system of claim 1, wherein, the transmyocardial wiper comprises a plurality of wiper apertures positioned along a length of the transmyocardial wiper, the transmyocardial wiper suture extending sequentially through the plurality of wiper apertures.

3. The pericardial anchoring system of any one of claims 1-2, wherein, the transmyocardial wiper suture is woven sequentially through the plurality of wiper apertures and sequentially adjacent to a first side of the transmyocardial wiper and a second side of the transmyocardial wiper opposite the first side of the transmyocardial wiper.

4. The pericardial anchoring system of claim 3, wherein, the transmyocardial wiper suture traverses sequentially from a distal end of the transmyocardial wiper through the plurality of wiper apertures to a proximal end of the transmyocardial wiper and back to the distal end of the transmyocardial wiper, wherein the proximal end of the transmyocardial wiper is adjacent to the pericardial anchor.

5. The pericardial anchoring system of any one of claims 3-4, wherein, the transmyocardial wiper suture comprises a first end of the transmyocardial wiper suture and a second end of the transmyocardial wiper suture opposite the first end of the transmyocardial wiper suture, wherein the first end of the transmyocardial wiper suture comprises a compression element having a dimension that prevents the compression element from passing through a first aperture of the plurality of wiper apertures, the compression element operable to engage and compress the transmyocardial wiper upon application of tension to the second end of the transmyocardial wiper suture.

6. The pericardial anchoring system of any one of claims 3-5, wherein, the compression element is a knot defined by the first end of the transmyocardial wiper suture.

7. The pericardial anchoring system of claim 6, wherein, the compression element is configured to translate along the second end of the transmyocardial wiper suture.

8. The pericardial anchoring system of any one of claims 6-7, wherein, the compression element is a knot and a loop defined by the first end of the transmyocardial wiper suture, the loop operable to slidingly receive the second end of the transmyocardial wiper suture therethrough.

9. The pericardial anchoring system of claim 6, wherein, the compression element is a loop coupled with the first end of the transmyocardial wiper suture, the second end of the transmyocardial wiper suture slidingly received through the loop.

10. The pericardial anchoring system of claim 6, wherein, the loop is a circle.

11. The pericardial anchoring system of claim 10, wherein, translation of the compression element along the second end of the transmyocardial wiper suture in a direction toward the pericardial anchor is configured to cinch the transmyocardial wiper.

12. The pericardial anchoring system of any one of claims 8-11, wherein, a suture tail is integral with or coupled to the compression element, wherein the transmyocardial wiper suture is operable to be removed from the transmyocardial wiper upon application of tension to the suture tail in a direction away from the pericardial anchor while the transmyocardial wiper suture is slidingly removed from the plurality of wiper apertures.

13. The pericardial anchoring system of any of claims 8-12, wherein, a wiper aperture distance between at least two of the wiper apertures is greater than a maximum transverse dimension of the transmyocardial wiper operable to fold the transmyocardial wiper to a greater dimension in a transverse direction when in the cinched configuration relative to the wiper maximum transverse dimension when in the elongated configuration upon application of tension to the second end of the transmyocardial wiper suture.

14. The pericardial anchoring system of any one of claims 2-12, wherein, ​ 15. The pericardial anchoring system of any one of claims 2-14, wherein, A swab hole distance between at least two swab holes is greater than twice a maximum transverse dimension of the transmyocardial swab operable to fold the transmyocardial swab to a greater dimension in a transverse direction when in the cinched configuration relative to a maximum transverse dimension of the transmyocardial swab when in the elongated configuration when tension is applied to the suture second end of the transmyocardial swab.

16. The pericardial anchoring system of any one of claims 2-15, wherein, The plurality of swab holes are not positioned collinearly along the longitudinal direction of the transmyocardial swab operable to fold the transmyocardial swab to a greater dimension in a transverse direction when in the cinched configuration relative to a maximum transverse dimension of the transmyocardial swab when in the elongated configuration when tension is applied to the suture second end of the transmyocardial swab.

17. The pericardial anchoring system of any one of claims 1-16, wherein, Also included are: a pericardial anchor; a pericardial anchor suture coupled to the pericardial anchor; a suture lock configured to interact with the pericardial anchor suture; and an anchor socket configured to house the suture lock.

18. A pericardial anchor system comprising: a pericardial anchor; a transmyocardial swab extending from a proximal portion of the pericardial anchor; a pericardial anchor suture coupled to the pericardial anchor; a transmyocardial swab suture coupled to the transmyocardial swab; a suture lock configured to interact with the pericardial anchor suture; and an anchor socket configured to house the suture lock, wherein the pericardial anchor is operable to transition between a pre-deployed configuration and a deployed configuration, wherein the transmyocardial swab is operable to transition between a pre-cinched configuration and a cinched configuration, wherein the transmyocardial swab and the pericardial anchor are independently operable. The anchor socket is further configured to constrain and dock the suture lock.

19. The pericardial anchoring system of claim 18, wherein, The suture lock secures the pericardial anchor suture.

20. The pericardial anchoring system of claim 18, wherein, The transmyocardial swab includes a plurality of holes positioned along a length of the transmyocardial swab.

21. The pericardial anchoring system of claim 18, wherein, The transmyocardial swab suture is woven through the plurality of holes.

22. The pericardial anchoring system of claim 21, wherein, The transmyocardial swab suture is woven through the plurality of holes from a distal end to a proximal end and back to the distal end.

23. The pericardial anchoring system of claim 21, wherein, The transmyocardial swab is configured to form a cinched shape, bundle, or mass in the cinched configuration.

24. The pericardial anchoring system of claim 18, wherein, The transmyocardial swab suture includes a compression element.

25. The pericardial anchoring system of claim 18, wherein, The compression element is configured to translate along the transmyocardial swab suture.

26. The pericardial anchoring system of claim 25, wherein, The compression element is configured to translate along a second end of the transmyocardial swab suture.

27. The pericardial anchoring system of claim 25, wherein, A first end of the transmyocardial swab suture is slidingly received through the compression element, the compression element operable to translate along a second end of the transmyocardial swab suture.

28. The pericardial anchoring system of claim 25, wherein, Translation of the compression element along the transmyocardial swab suture in a direction toward the pericardial anchor is configured to cinch the transmyocardial swab.

29. The pericardial anchoring system of claim 26, wherein, The compression element is a no-slip knot.

30. The pericardial anchoring system of claim 25, wherein, The compression element applies pressure to a surface of the transmyocardial swab to transition the transmyocardial swab to the cinched configuration.

31. The pericardial anchoring system of claim 25, wherein, A minimum tension is applied to the transmyocardial swab suture when the transmyocardial swab is in the cinched configuration.

32. The pericardial anchoring system of claim 31, wherein, ​ 33. The pericardial anchoring system of claim 21, wherein, A predetermined resistance between the transmyocardial swab suture and the plurality of swab holes is operable to prevent relative movement of the transmyocardial swab suture and the transmyocardial swab in the cinched configuration.

34. The pericardial anchoring system of claim 31, wherein, Translation of the compression element along the transmyocardial swab suture in a direction away from the pericardial anchor has minimal effect on the cinched configuration of the transmyocardial swab.

35. The pericardial anchoring system of claim 25, wherein, The compression element is a microswab.

36. The pericardial anchoring system of claim 25, wherein, The compression 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 compression element along a swab suture woven through a transmyocardial swab in a pre-cinched configuration to transition the transmyocardial swab to a cinched configuration; and locking the transmyocardial swab in the cinched configuration.

38. The method of claim 37, wherein, The compression element exerts pressure on a surface of the transmyocardial swab to transition the transmyocardial swab to the cinched configuration.

39. The method of claim 37, wherein, A predetermined resistance locks the transmyocardial swab in the cinched configuration.

40. The method of claim 37, wherein, The compression element is translated in a direction toward the pericardial anchor to transition the transmyocardial swab to the cinched configuration.

41. The method of claim 37, wherein, Minimal tension is applied to the swab suture when the transmyocardial swab is in the cinched configuration.

42. The method of claim 37, wherein, Further comprising guiding the pericardial anchor suture and the swab suture through a suture lock within an anchor socket connected to the transmyocardial swab.

43. The method of claim 37, wherein, Deployment of the pericardial anchor comprises forming a disc.

44. A method of mitral valve chord repair, the method comprising: anchoring a pericardial anchor by applying tension to a pericardial anchor suture integrated with the pericardial anchor; cinching a transmyocardial swab by translating a compression element along a swab suture integrated with the transmyocardial swab; connecting the pericardial anchor suture, the swab suture, and at least one leaflet anchor suture integrated with at least one leaflet anchor to a suture lock within an anchor socket connected to the transmyocardial swab; locking the pericardial anchor suture to the suture lock; locking the at least one leaflet anchor suture.

45. The method of claim 44, wherein, The compression element is translated in a direction toward the pericardial anchor to transition the transmyocardial swab to a cinched configuration.

46. The method of claim 45, wherein, Minimal tension is applied to the swab suture when the transmyocardial swab is in the cinched configuration.

47. The method of claim 45, wherein, A predetermined resistance maintains the transmyocardial swab in the cinched configuration.

Citation Information

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