Pericardial Fixation System

Abstract

The pericardial fixation system includes a pericardial anchor, a transmyocardial pledget extending from a proximal end of the pericardial anchor, and a transmyocardial pledget suture coupled to the transmyocardial pledget, the transmyocardial pledget suture operable to deform the transmyocardial pledget from an elongated configuration to a post-fastened configuration defining a longitudinally shortened dimension when tension is applied to an end of the transmyocardial pledget suture.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of Provisional Application No. 63 / 480,929, filed January 20, 2023, the entirety of which is incorporated herein by reference for all purposes.

[0002] Field FIELD OF THE DISCLOSURE The present disclosure relates generally to cardiac device fixation, and more particularly to apparatus, systems and methods involving accessing and fixation in the pericardial space. [Background technology]

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

[0004] Abstract The described embodiments relate to devices, systems and methods for pericardial fixation.

[0005] According to one example ("Example 1"), a pericardial fixation system includes a pericardial anchor, a transmyocardial pledget extending from a proximal end of the pericardial anchor, and a transmyocardial pledget suture coupled to the transmyocardial pledget, the transmyocardial pledget suture operable to deform the transmyocardial pledget from an elongated configuration to a post-fastened configuration defining a longitudinally shortened dimension when tension is applied to an end of the transmyocardial pledget suture.

[0006] According to another example ("Example 2"), the pericardial fixation system of Example 1, wherein the transmyocardial pledget suture is operable to deform the transmyocardial pledget from an elongated configuration to a post-fastened 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 fixation system of Example 1 or Example 2, wherein the transmyocardial pledget includes a plurality of pledget apertures disposed along the length of the transmyocardial pledget, and the transmyocardial pledget suture extends sequentially through the plurality of pledget apertures.

[0008] According to another example ("Example 4"), the pericardial fixation system of Example 3 is such that the transmyocardial pledget sutures are woven sequentially through the plurality of pledget apertures and sequentially positioned adjacent to a first surface of the transmyocardial pledget and a second surface of the transmyocardial pledget opposite the first surface of the transmyocardial pledget.

[0009] According to another example ("Example 5"), the pericardial fixation system of Examples 3 and 4, wherein the transmyocardial pledget suture traverses sequentially through the multiple pledget apertures from the distal end of the transmyocardial pledget to the proximal end of the transmyocardial pledget and returns to the distal end of the transmyocardial pledget, the proximal end of the transmyocardial pledget being adjacent to the pericardial anchor.

[0010] According to another example ("Example 6"), the pericardial fixation system of any of Examples 3 to 5, wherein the transmyocardial pledget suture includes a first end of the transmyocardial pledget suture and a second end of the transmyocardial pledget suture opposite the first end of the transmyocardial pledget suture, the first end of the transmyocardial pledget suture including a compression element, the compression element having dimensions that prevent the compression element from passing through a first aperture of a plurality of pledget apertures, and the compression element is operable to engage with and compress the transmyocardial pledget when tension is applied to the second end of the transmyocardial pledget suture.

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

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

[0013] According to another example ("Example 9"), the pericardial fixation system of Example 6, wherein the compression element is a first end of the transmyocardial pledget suture defining the knot and a loop operable to slidably receive a second end of the transmyocardial pledget suture.

[0014] According to another example ("Example 10"), the pericardial fixation system of Example 6, wherein the compression element is a loop coupled to a first end of the transmyocardial pledget suture, and a second end of the transmyocardial pledget suture is slidably received therethrough.

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

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

[0017] According to another example ("Example 13"), the pericardial fixation system of any of Examples 8 to 12 includes a suture tail that is integral with or coupled to the compression element, and when tension is applied to the suture tail in a direction away from the pericardial anchor, the transmyocardial pledget suture is operable to detach from the transmyocardial pledget, and the transmyocardial pledget suture is slid out of the multiple pledget apertures and detached.

[0018] According to another example ("Example 14"), the pericardial fixation system of any of Examples 2 to 12, wherein a pledget aperture distance between at least two pledget apertures is greater than a maximum transverse dimension of the transmyocardial pledget, and the transmyocardial pledget is operable, when tension is applied to the second end of the transmyocardial pledge suture, to collapse the transmyocardial pledge to a larger transverse dimension in a tightened configuration relative to the maximum transverse dimension of the pledget in an elongated configuration.

[0019] According to another example ("Example 15"), the pericardial fixation system of any of Examples 2 to 14, wherein a pledget aperture distance between at least two pledget apertures is greater than twice the maximum transverse dimension of the transmyocardial pledget, and the transmyocardial pledget is operable, when tension is applied to the second end of the transmyocardial pledge suture, to collapse the transmyocardial pledge to a larger transverse dimension in a tightened configuration relative to the maximum transverse dimension of the pledget in an elongated configuration.

[0020] According to another example ("Example 16"), the pericardial fixation system of any of Examples 2 to 15, wherein the plurality of pledget apertures are not aligned in the same line along the longitudinal direction of the transmyocardial pledget, and the transmyocardial pledget is operable, when tension is applied to the second end of the transmyocardial pledge suture, to collapse the transmyocardial pledget to a larger transverse dimension in a tightened configuration relative to the maximum transverse dimension of the transmyocardial pledge in the elongated configuration.

[0021] According to another example ("Example 17"), the pericardial fixation system of any of Examples 1 to 16, further comprising 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 accommodate the suture lock.

[0022] According to another example ("Example 18"), a pericardial fixation system includes 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 receive the suture lock, wherein the pericardial anchor is operable to be deformable between a pre-deployment configuration and a post-deployment configuration, the transmyocardial pledge is operable to be deformable between a pre-clamped configuration and a post-clamped configuration, and the transmyocardial pledget and the pericardial anchor are independently operable.

[0023] According to another example ("Example 19"), the pericardial fixation system of Example 18, wherein the anchor socket is further configured to restrain and dock the suture lock.

[0024] According to another example ("Example 20"), the pericardial fixation system of Example 18, wherein the suture lock secures the pericardial anchor suture.

[0025] According to another example ("Example 21"), the pericardial fixation system of Example 18, wherein the transmyocardial pledget includes a plurality of apertures disposed along a length of the transmyocardial pledget.

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

[0027] According to another example ("Example 23"), the pericardial fixation system of Example 21 is such that the transmyocardial pledget suture is woven through the multiple apertures from the distal end to the proximal end and back to the distal end.

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

[0029] According to another example ("Example 25"), the pericardial fixation system of Example 18, wherein the transmyocardial pledget suture includes a compression element.

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

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

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

[0034] According to another example ("Example 30"), the pericardial fixation system of Example 25, wherein the compression element is a non-slip loop knot.

[0035] According to another example ("Example 31"), the pericardial fixation system of Example 25, wherein the compression element applies pressure to a surface of the transmyocardial pledget to deform the transmyocardial pledget into a clamped configuration.

[0036] According to another example ("Example 32"), the pericardial fixation system of Example 31, wherein minimal tension is applied to the transmyocardial pledget suture when the transmyocardial pledget is in a post-cinched configuration.

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

[0038] According to another example ("Example 34"), the pericardial fixation system of Example 31, wherein translating the compression element along the transmyocardial pledget suture and away from the pericardial anchor minimally affects the post-fastening configuration of the transmyocardial pledget.

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

[0040] According to another example ("Example 36"), the pericardial fixation 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 fixation system includes applying tension to pericardial anchor sutures woven through a pericardial anchor to deploy it, translating a compression element along pledget sutures woven through a transmyocardial pledget in a pre-clamped configuration to transform the transmyocardial pledget into a post-clamped configuration, and securing the transmyocardial pledget in the post-clamped configuration.

[0042] According to another example ("Example 38"), the pericardial fixation system of Example 37, wherein the compression element applies pressure to a surface of the transmyocardial pledget to deform the transmyocardial pledget into a clamped configuration.

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

[0044] According to another example ("Example 40"), the pericardial fixation system of Example 37, wherein the compression element translates in a direction toward the pericardial anchor to deform the transmyocardial pledget to a post-fastening configuration.

[0045] According to another example ("Example 41"), the pericardial fixation system of Example 37, wherein minimal tension is applied to the pledget suture when the transmyocardial pledget is in a clamped configuration.

[0046] According to another example ("Example 42"), the pericardial fixation system of Example 37 further includes passing the pericardial anchor suture and the pledget suture through a suture lock in an anchor socket connected to the transmyocardial pledget.

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

[0048] According to another example ("Example 44"), a method for mitral valve chordae repair includes securing a pericardial anchor by applying tension to a pericardial anchor suture integrated with a pericardial anchor; tightening the 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 in 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 fixation system of Example 44, wherein the compression element is translated in a direction toward the pericardial anchor to deform the transmyocardial pledget to a post-fastening configuration.

[0050] According to another example ("Example 46"), the pericardial fixation system of Example 45, wherein minimal tension is applied to the pledget suture when the transmyocardial pledget is in a post-cinched configuration.

[0051] According to another example ("Example 47"), the pericardial fixation system of Example 45, wherein a desired resistance maintains the transmyocardial pledget in the clamped configuration. [Brief explanation of the drawings]

[0052] BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings are included to provide a further understanding of the present disclosure, and are incorporated in and constitute a part of this specification, illustrating embodiments and, together with the description, serving to explain the principles of the present disclosure.

[0053] [Figure 1A] FIG. 1A is a side view of a fixation system according to an embodiment.

[0054] [Figure 1B] FIG. 1B is a side view of the fixation system of FIG. 1A.

[0055] [Figure 2A] FIG. 2A is a cross-sectional view of the heart.

[0056] [Figure 2B] FIG. 2B is a close-up cross-sectional view of the heart of FIG. 2A.

[0057] [Figure 3] FIG. 3 is a cross-sectional view of a heart including a guidewire according to one embodiment of a method for providing a pericardial fixation system.

[0058] [Figure 4]FIG. 4 is a cross-sectional view of a heart including a guidewire according to one embodiment of a method for providing a pericardial fixation system.

[0059] [Figure 5A] FIG. 5A is a cross-sectional view of a heart including a guidewire according to one embodiment of a method for providing a pericardial fixation system.

[0060] [Figure 5B] FIG. 5B is a cross-sectional view of a heart including a guidewire according to one embodiment of a method of providing a pericardial fixation system.

[0061] [Figure 6] FIG. 6 is a cross-sectional view of a heart including a guidewire and needle catheter according to one embodiment of a method for providing a pericardial fixation system.

[0062] [Figure 7] FIG. 7 is a cross-sectional view of a heart including a guidewire and needle catheter according to one embodiment of a method for providing a pericardial fixation system.

[0063] [Figure 8] FIG. 8 is a cross-sectional view of a heart including a guidewire and a catheter according to one embodiment of a method for providing a pericardial fixation system.

[0064] [Figure 9] FIG. 9 is a cross-sectional view of a heart including a catheter and fixation system according to one embodiment of a method for providing a pericardial fixation system.

[0065] [Figure 10] FIG. 10 is a cross-sectional view of a heart including a deployed catheter and fixation system according to one embodiment of a method for providing a pericardial fixation system.

[0066] [Figure 11]FIG. 11 is a cross-sectional view of a heart including a deployed fixation system according to one embodiment of a method of providing a pericardial fixation system.

[0067] [Figure 12] FIG. 12 is a cross-sectional view of a heart including a deployed fixation system with a sealing means according to one embodiment of a method for providing a pericardial fixation system.

[0068] [Figure 13] FIG. 13 is a cross-sectional view of a heart including a fixation system deployed using a tether lock according to one embodiment of a method of providing a pericardial fixation system.

[0069] [Figure 14] FIG. 14 is a cross-sectional view of a heart including a fixation system deployed and coupled to the mitral valve leaflets to prevent prolapse, according to one embodiment of a method of providing a pericardial fixation system.

[0070] [Figure 15] FIG. 15 is a flow diagram of one embodiment of a method for providing a pericardial fixation system.

[0071] [Figure 16] FIG. 16 is a flow diagram of one embodiment of a method for providing a pericardial fixation system.

[0072] [Figure 17] FIG. 17 is a flow diagram of one embodiment of a method for providing a pericardial fixation system.

[0073] [Figure 18] FIG. 18 is an example of a pericardial fixation system in a deployed configuration, according to one embodiment.

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

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

[0076] [Figure 21A] FIG. 21A is a wireframe example of a pericardial anchor in a deployed configuration, according to one embodiment.

[0077] [Figure 21B] FIG. 21B is an example of a transmyocardial pledget with a t-bar proximal leg.

[0078] [Figure 22] FIG. 22 is an exemplary embodiment of a transmyocardial pledget in a pre-clamped configuration.

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

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

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

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

[0083] [Figure 26] FIG. 26 is an exemplary embodiment of a transmyocardial pledget in a post-clamping configuration.

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

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

[0086] [Figure 28] FIG. 28 is an exemplary embodiment of a pericardial fixation system.

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

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

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

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

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

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

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

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

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

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

[0097] [Figure 33A] FIG. 33A is an exemplary embodiment of a small pledget.

[0098] [Figure 33B] FIG. 33B is an exemplary embodiment of a small pledget.

[0099] [Figure 33C] FIG. 33C is an exemplary embodiment of a small pledget.

[0100] [Figure 33D] FIG. 33D is an exemplary embodiment of a small pledget.

[0101] [Figure 34] FIG. 34 is an example of a pericardial fixation system and leaflet fixation system deployed and implanted within the heart according to one embodiment.

[0102] [Figure 35A] FIG. 35A is an example of a leaflet anchor implanted in a valve leaflet and leaflet anchor sutures extending between the leaflet anchor and a pericardial fixation system implanted in the ventricular wall, according to one embodiment.

[0103] [Figure 35B] FIG. 35B is a cross-sectional view of a ventricular wall with an implanted pericardial fixation system, according to one embodiment.

[0104] [Figure 35C] FIG. 35C is an illustration of a pericardial anchor (pericardium not shown for clarity) implanted within the pericardial space, according to one embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0105] Detailed Description Those skilled in the art will readily appreciate that the various aspects of the present disclosure may be implemented by any number of methods and apparatus configured to perform the intended functions. It should also be noted that the accompanying drawings referred to herein are not necessarily drawn to scale and may be exaggerated to illustrate various aspects of the present disclosure, and in that regard, the drawings should not be construed as limiting.

[0106] Although embodiments herein may be described in connection with various principles and beliefs, the described embodiments should not be bound by theory. For example, embodiments herein are described in connection with preventing mitral valve leaflet prolapse with a fixation system contained within a pericardial cavity. However, embodiments within the scope of the present disclosure may be applied to any prosthetic device or mechanism of similar structure and / or function that requires fixation within a cardiac chamber.

[0107]

[0003] Embodiments herein include various devices, systems, and methods for sutures or other tether mechanisms with anchors located within the pericardial space, which extend through the myocardium and endocardium and are used to attach to biological elements such as mitral valve leaflets or prosthetic devices such as, but not limited to, sensors or support structures. The anchors, located adjacently within the epicardium (the visceral layer of the serous pericardium), can be any suitable structure, such as, but not limited to, umbrella elements, pledgets, or multi-legged support structures. The anchors are operable to pass through narrow access channels in the heart wall, expand or deploy to a larger diameter or surface area within the pericardial space, and have a low profile to avoid passing through narrow access channels within cardiac structures. The present disclosure relates to mitral valve repair or replacement, and more generally, to methods and devices for mitral valve reconstruction, repair and / or replacement of mitral valve chordae (also called chordae tendineae) to restore proper function of the mitral valve from dysfunctional conditions 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" refer to the space defined by or between the heart wall and the pericardium, or the space between the visceral and parietal pericardium.

[0110] As used herein, the term "coupled" means joined, connected, attached, adhered, affixed or joined, whether directly or indirectly, and whether permanently or temporarily.

[0111] The term "pericardial anchor" is used herein to describe the anchor of a pericardial fixation system, although the anchor of a pericardial system may also be referred to as a pericardial anchor or anchors.

[0112] According to an embodiment, as shown in FIG. 17, the pericardial anchor is provided by a small hollow needle catheter (e.g., 20-25 gauge) and a compatible guidewire (e.g., 0.010-0.018 inch operable to fit into the lumen of the needle catheter). Transmurality from within the cardiac chamber begins with the needle catheter passing through the endocardium into the myocardium and is completed by the guidewire passing through the remainder of the myocardium and through the epicardium. The guidewire is positioned within the pericardial space, allowing the anchors of the anchoring system to then be delivered over the guidewire into the pericardial space.

[0113] Its extremely small size reduces the risk of adverse events, such as a lower likelihood of causing pericardial effusion / tamponade.

[0114] Crossing the epicardium with a guidewire instead of a needle catheter can improve safety and potentially ease of use of the procedure by eliminating guesswork / ambiguity about entering the pericardial space too short or too far, for example, due to difficulties in imaging and / or understanding placement within the pericardial space. The stiffness of the guidewire can be optimized, for example, both at the distal end and along its entire length, so that the distal end is stiff enough to cross the remainder of the heart wall and enter the pericardial space, but soft enough not to deflect and puncture the pericardium (serous pericardium and parietal lamina of fibrous pericardium). The guidewire is operable to roll up and advance within the pericardial space. Advancing the distal end of the guidewire into the pericardial space and adjacent to the heart wall can provide the physician with evidence that the distal end of the guidewire is within the pericardial space.

[0115] When the guidewire outer diameter is slightly smaller than the needle inner diameter, the possibility of perforating the heart wall is reduced or minimized, reducing tissue damage. The needle catheter and guidewire can be inserted in a nested or tandem configuration, with the guidewire distal tip pulled back only slightly relative to the needle catheter distal tip. After the needle catheter punctures the endocardium, the guidewire can be advanced beyond the needle catheter distal tip while the needle catheter supports the guidewire.

[0116] It will be appreciated that there are various methods for advancing the small hollow needle catheter and then the nested guidewire to the target location. In one embodiment, the needle catheter can be advanced over a pre-placed guidewire using an over-the-wire technique, such as, but not limited to, from a femoral vein access port. In other embodiments, the needle catheter can be advanced through the lumen of a pre-placed steerable or non-steerable sheath, support / guide catheter, or the like, with or without a nested guidewire.

[0117] It is understood that after the guidewire has passed through the pericardial space, several additional steps may need to be performed before advancing the fixation system. By way of example, and not limitation, contrast agents, CO2, microcatheters, various guidewires, support / guide catheters, and other devices, drugs, and therapeutic agents may be used for specific purposes, such as, but not limited to, creating physical space in the pericardial space at the target site, visualizing the pericardial space and / or cardiac / pericardial structures at the target site, and securing a guidewire of appropriate stiffness and precise diameter within the pericardium for delivery of the fixation system.

[0118] According to embodiments, diagnostic modalities can be employed to provide evidence that the guidewire has passed through the heart wall and entered the pericardial space. By way of example, such diagnostic modalities can include, but are not limited to, guidewires attached to ECG leads (such as guidewires having a non-conductive coating except for the proximal and distal tips) and pressure-sensing guidewires with sensing elements at their distal tips. Data collected from these modalities can provide evidence that the guidewire has passed through the heart wall and entered the pericardial space.

[0119] Pericardial Fixation System 1A and 1B are side views of a fixation system 30 including an anchor 32 and a tether 34 coupled to the anchor 32. The anchor 32 is operable to have a low profile 33 in a first position 36 and a wider profile 37 in a second position 38. The anchor 32 is operable to advance from the chamber 6 of the heart 2 through a narrow access channel 12 in the heart wall 41 into the pericardial space 10 in the first position 36 and expand within the pericardial space 10 to a second position 38, where it is larger in size than the narrow access channel 12.

[0120] 2A and 2B are cross-sectional views of the heart 2 and its corresponding anatomical features.

[0121] Guidewire Advancement / Insertion 3-14 are a series of diagrams, and FIG. 15 is a flow diagram of a method of providing an anchor 32 within a heart chamber 6, according to one embodiment. The femoral vein is accessed and a guidewire 40 is advanced therein. The guidewire 40 is advanced through the femoral vein into the right atrium 20 (FIG. 3). The guidewire 40 is advanced through the septum 26 into the left atrium 24 (FIG. 4). The guidewire 40 is advanced through the mitral valve 8 to and adjacent to the heart wall 41 of the left ventricle 22 (FIGS. 5A and 5B). A needle catheter 42 is advanced along the guidewire 40, approximately halfway through the thickness 16 of the myocardium 13 (FIG. 6). A guidewire 40 having a stiff distal tip is advanced through the needle catheter 42, through the epicardium 14, and into the pericardial space 10 (FIG. 7). The length of the guidewire advanced into the pericardial space 10 can be minimized. The guidewire may be configured to coil or assume a coiled shape as it is advanced into the pericardial space 10. To maintain the integrity of the heart wall, it may be advantageous to minimize the length of the guidewire inserted into the pericardial space 10. A catheter 44 is advanced over the guidewire 40 into the pericardial space 10 ( FIG. 8 ). A gas, such as carbon dioxide, may be used to inflate the pericardium 18 and separate it from the heart wall 41, thereby enlarging the pericardial space 10. The fixation system 30 may be advanced over the guidewire 40 after removal of the catheter 44 and / or through the catheter 44 after removal of the guidewire 40 ( FIG. 9 ), or may be advanced over the guidewire 40 while the guidewire 40 remains in place within the catheter 44. The fixation system 30 may be mediated by a fixation system delivery catheter operable to deliver and deploy the fixation system. Anchors are deployed within the pericardial space 10 and positioned against the epicardium 14 ( FIG. 10 ). The fixation system 30 includes a suture or tether 34 that is coupled to an anchor 32, and the suture or tether 34 is placed within the heart chamber 6 (FIG. 11).

[0122] It is expected that once the delivery system, i.e., guidewire 40 and / or catheter 44, is removed from heart 2, the heart wall 41 will seal around the suture or tether 34, eliminating the need for additional materials to prevent migration of blood from the left ventricle into the pericardial space, which may be caused by the formation of access channel 12. It is expected that, in some cases, sealing means 48 may be provided to reduce or eliminate the possibility of migration of blood from the left ventricle into the pericardial space. Such sealing means 48 may include, but are not limited to, a surface texture on tether 34 to induce a healing response between tether 34 and heart wall 41, a pledget along tether 34 that may be used to occlude access channel 12, or an expandable portion or element around tether 34 and / or anchor 32 operable to close access channel 12 around tether 34 and / or anchor 32 ( FIG. 12 ).

[0123] In some embodiments, three levels of sealing can occur when the delivery system is removed from the access channel. The access channel can be sealed inside the epicardium, outside the epicardium, and through the access channel to the epicardium. The size of the delivery system can affect the amount or degree of sealing that can occur after removal of the delivery system. In some embodiments, smaller delivery systems can make it easier to achieve the three levels of sealing and return the epicardium to its pre-injury state.

[0124] 13, a tether lock 35 is operable to be advanced over the tether 34 and engage the tether 34 against the endocardium 11, capturing and securely holding the heart wall 41 between the tether lock 35 and the anchor. Such a tether lock 35 is operable to ensure secure engagement of the anchor 32 with the endocardium 11 and prevent its migration, e.g., to prevent subsequent irritation to the pericardium 18.

[0125] As previously mentioned, the sutures or tethers 34 can be used for specific purposes. According to one embodiment, the sutures or tethers 34 are attached to the mitral valve leaflets 9 to prevent the leaflets from prolapsing. This is shown in FIG. 14.

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

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

[0128] Anchor Deployment Overview According to another embodiment, shown in the flow diagram of FIG. 16 and with reference to FIGS. 1-14 , a fixation method includes advancing a guidewire 40 into the heart 2 up to and adjacent to the heart wall 41. The length of the guidewire advanced into the pericardial space 10 can be minimized. The guidewire can be coiled or configured to assume a coiled shape as it advances into the pericardial space 10. It can be advantageous to minimize the length of the guidewire inserted into the pericardial space 10 to maintain the integrity of the heart wall. A needle catheter 42 is advanced along the guidewire 40 to approximately halfway through the thickness 16 of the heart wall 41. The guidewire 40 is advanced through the needle catheter 42, through the epicardium 14, and into the pericardial space 10. The needle catheter 42 is removed from the guidewire 40. A catheter 44 is advanced along the guidewire 40 into the pericardial space 10. The pericardium 18 is separated from the heart wall 41, and the pericardial space 10 is enlarged. The fixation system 30 is advanced over the guidewire 40 or through the catheter 44, and its anchor portion 39 is positioned within the pericardial space 10. The anchor 32 of the fixation system 30 is deployed within the pericardial space 10 and positioned against the epicardium 14. The guidewire 40 and / or catheter 44 are removed from the patient, leaving the tether 34 coupled to the anchor 32 within the heart chamber 6.

[0129] According to another embodiment, the fixation method optionally includes advancing a support catheter into the heart, near or up to, and adjacent to or against the heart wall. The anchor catheter is advanced alone or through the optional support catheter and positioned near or in pressing engagement with the heart wall. A guidewire is advanced through the anchor catheter, through the endocardium, myocardium, and epicardium (visceral layer of the serous pericardium) of the heart wall, and into the pericardial space. The anchor catheter is advanced along the guidewire, through the endocardium, myocardium, and epicardium (visceral layer of the serous pericardium) of the heart wall, and into the pericardial space. Optionally, the guidewire is removed from the pericardial space. Optionally, the pericardium is separated from the epicardium, enlarging the pericardial space. An anchor of the fixation system is advanced or exposed through, at, or near the distal end of the anchor catheter within the pericardial space, and the anchor is positioned within the pericardial space. The anchors of the fixation system are deployed within the pericardial cavity, with the anchors positioned against the epicardium, and the guidewire and / or anchor catheter and / or support catheter are removed from the patient, leaving the tethers coupled to the anchors within the cardiac chamber.

[0130] According to another embodiment, a fixation method includes advancing an anchoring catheter near or up to and against the heart wall within a heart chamber. A guidewire is advanced through the anchoring catheter such that a distal tip of the guidewire passes through the endocardium, into the myocardium, passes through the epicardium, and advances into the pericardial space. The distal tip of the anchoring catheter is advanced along or over the guidewire into or adjacent to the pericardial space. An anchor of a fixation system is advanced or exposed through or at the distal end of the anchoring catheter within the pericardial space, with the anchor positioned within the pericardial space. The anchor of the fixation system is deployed within the pericardial space, with the anchor positioned against the epicardium. The guidewire and / or anchoring catheter are removed from the patient, leaving a tether coupled to the anchor of the fixation system in the pericardial space over the guidewire within the heart chamber.

[0131] Fixing method A fixation method according to one embodiment provides a fixation system as described above, advancing a guidewire into the femoral vein, advancing the guidewire through the femoral vein into the right atrium, advancing the guidewire through the septum into the left atrium, advancing the guidewire through the mitral valve to and adjacent the heart wall of the left ventricle, advancing a needle catheter over the guidewire through the endocardium of the heart wall into the myocardium, advancing the guidewire through the needle catheter through the myocardium and epicardium into the pericardial space, removing the needle catheter from the guidewire, advancing the catheter over the guidewire into the pericardial space, inflating the pericardium to separate it from the heart wall and enlarge the pericardial space, and fixation. the anchoring system is advanced over the guidewire or through the catheter, wherein the anchor is disposed within the pericardial cavity; deploying the anchor of the fixation system within the pericardial cavity and disposing the anchor against the epicardium, wherein the anchor is in a straight configuration in the pre-deployment configuration due to tension at the first end of the tether and the second end of the tether, and the anchor is in a ring configuration in the post-deployment configuration due to tension at the first end of the tether and the second end of the tether; and removing the guidewire and / or catheter from the patient to leave the tether coupled to the anchor within the cardiac chamber.

[0132] A fixation method according to one embodiment includes providing a fixation system as described above, advancing a guidewire into the needle catheter so that a distal tip of the guidewire is adjacent to the distal tip of the needle catheter, advancing the distal tip of the needle catheter from the heart chamber through the endocardium of the heart wall into the myocardium, advancing the distal tip of the guidewire through the myocardium and epicardium into the pericardial cavity, advancing an anchor of the fixation system over the guidewire into the pericardial cavity, and deploying the anchor in the pericardial cavity, wherein the anchor is in a straight configuration in a pre-deployment configuration due to tension at the first end of the tether and the second end of the tether, and the anchor is in a ring configuration in a post-deployment configuration due to tension at the first end of the tether and the second end of the tether.

[0133] A fixation method according to one embodiment provides a fixation system as described above, advancing a support catheter into the heart, up to and adjacent to or against the heart wall, advancing an anchor catheter alone or through the support catheter and engaging and positioning it against the heart wall, advancing a guidewire along or through the anchor catheter, through the endocardium, myocardium and epicardium (visceral layer of the serous pericardium) of the heart wall and into the pericardial space, advancing the anchor catheter along or over the guidewire, through the endocardium, myocardium and epicardium (visceral layer of the serous pericardium) of the heart wall and into the pericardial space, The method includes advancing or exposing an anchor of the fixation system through or at the distal end of the anchor catheter within the cavity, wherein the anchor is positioned within the pericardial cavity; deploying the anchor of the fixation system within the pericardial cavity and positioning the anchor against the epicardium, wherein the anchor has a straight configuration in a pre-deployment configuration due to tension at the first end of the tether and the second end of the tether, and a ring-shaped configuration in a post-deployment configuration due to tension at the first end of the tether and the second end of the tether; and removing the guidewire and anchor catheter from the patient, leaving the tether coupled to the anchor within the cardiac chamber.

[0134] A fixation method according to one embodiment provides a fixation system as described above, advancing an anchor catheter into a cardiac chamber up to and against the heart wall, advancing a guidewire through the anchor catheter such that a distal tip of the guidewire passes through the endocardium into the myocardium and through the epicardium into the pericardial space, advancing the distal tip of the anchor catheter along or over the guidewire into or adjacent the pericardial space, and advancing or extending an anchor of the fixation system through or at the distal end of the anchor catheter within the pericardial space. wherein the anchor is positioned within the pericardial cavity; deploying anchors of the fixation system within the pericardial cavity and positioning the anchors against the epicardium, wherein the anchors are in a straight configuration due to tension on the first and second ends of the tether in a pre-deployment configuration and the anchors are in a ring-shaped configuration due to tension on the first and second ends of the tether in a post-deployment configuration; and removing the guidewire and anchor catheter from the patient to leave the tether coupled to the anchors of the fixation system over the guidewire and in the pericardial cavity within the cardiac chamber.

[0135] Anchor skirt with wire frame The pericardial anchor 220 can include a wire or wire frame 222 coupled to a skirt 230. FIG. 21 is a plan view of the wire frame 222 in an unconstrained, curved configuration, according to one embodiment. The wire or wire frame 222 can be fabricated from nitinol, such as platinum-filled nitinol. As shown in FIG. 18, the skirt 230 or film can be any suitable biocompatible material, including, but not limited to, fluoropolymer films such as expanded polytetrafluoroethylene (ePTFE) and expanded polyethylene (ePE). The skirt 230 can have properties operable to promote tissue ingrowth. The 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 be resistant to breakage or tearing during disc formation.

[0136] The skirt 230 can include any material suitable for a particular purpose. For example, the skirt 230 material can be suitably flexible or compliant to facilitate deployment of the anchor from a straight configuration to a deployed configuration without fracture and / or unduly restricting deployment. For example, the skirt material can be suitably flexible so as not to overcome or unduly restrict the spring bias of the wire frame to a curved shape. Furthermore, the skirt material can be suitably flexible to conform to the epicardium upon deployment. Furthermore, the skirt material can be suitably durable to remain structurally sound for a period of time after deployment, subject to the dynamic motion of a beating heart.

[0137] The wire frame 222 can have a first end of the wire having a distal eyelet 224 and a second end of the wire having a proximal eyelet 226. The distal eyelet 224 and the proximal eyelet 226 can be termini of the wire frame 222. The distal eyelet 224 and the proximal eyelet 226 can be atraumatic ends of the wire frame 222. As shown in FIG. 21A , the distal eyelet 224 can be at the end of the wire frame, which can provide atraumatic protection to the tissue that it abuts. For example, the distal eyelet 224 can prevent the end of the wire frame from damaging tissue that it may come into contact with. As further shown in FIG. 21 , the proximal eyelet 226 can be positioned adjacent to and spaced apart from the end of the wire frame 222, which can position the end of the wire frame within the area surrounded by the wire frame 222. In other words, the ends of the wire frame can be contained within, i.e., protected by, the periphery of the wire frame 222. Furthermore, the proximal eyelets 226 can prevent the ends of the wire frame from damaging tissue with which they may come into contact. As shown in FIG. 21B , the wire frame 222 can have proximal legs or t-bar proximal legs 228 at the proximal portion of the wire frame 222 in a straight configuration. The t-bar 290 can function similarly to the t-bar proximal legs 228 of the pericardial anchor 220. The t-bar 290 can be positioned opposite the puncture in the myocardium within the epicardial space. This positioning can not only seal the puncture but also help prevent the pericardial anchor from deploying non-planarly and spreading under the t-bar itself. For example, the positioning of the t-bar 290 can provide a surface for the pericardial anchor to deploy. The film-covered t-bar 290 may be integral with or separate from the transmyocardial pledget 240. In some embodiments, the t-bar 290 may be deployed or positioned to seal the puncture before or after wrapping the skirt 230.

[0138] In the straight configuration, the proximal leg 228 can be disposed distal to the proximal eyelet 226 of the wire frame 222. The proximal leg 228 can be a straight portion of the wire frame 222 that remains straight in both the straight and curved configurations, and in this embodiment is ring-shaped.

[0139] The proximal legs 228 can be reinforced to resist tension or support forces relative to the remainder of the wire frame 222. According to one embodiment, the proximal legs 228 can include two sections of the same wire that are doubled so that they are parallel, in contact with each other, and bonded to each other. In some embodiments, the proximal legs 228 can have stiffer material properties than the remainder of the wire. This can advantageously allow the proximal legs 228 to resist bending and remain straight during deployment of the pericardial anchor 220, for example, while abutting the distal end of a delivery catheter, while the remainder of the wire frame 222 can be deployed to form a curved configuration. This can also advantageously improve actuation and tactile feedback experienced by the operator of the pericardial fixation system 200 when deploying and retracting the proximal legs 228. In one embodiment, proximal legs 228 are configured to maintain a straight position and abut pericardial anchor 220 against delivery catheter distal end 502 and the epicardial puncture, retaining pericardial anchor 220 within the pericardial space and preventing proximal legs 228 from passing through the epicardium or from moving back toward delivery catheter distal end 502 after entering the pericardial space. Proximal legs 228 are operable to prevent pericardial anchor 220 from being pulled proximally through the epicardial puncture.

[0140] According to one embodiment, proximal legs 228 are configured to maintain a straight configuration so that, in combination with the curved bias of the remainder of wire frame 222, they present a compressive engagement with a delivery catheter and assist in deployment of pericardial anchor 220. According to another embodiment, proximal legs 228 are configured to maintain a straight configuration so that, in combination with the curved bias of the remainder of wire frame 222, they present a profile operable to prevent the anchor from passing through an epicardial puncture after deployment.

[0141] The skirt 230 may be coupled to the wire frame 222 along an edge defining its length. The wire frame 222 may be disposed at one end or edge of the skirt 230. In one embodiment, a tether or pericardial anchor suture 280 is coupled to the opposite edge of the skirt 230. According to another embodiment, a plurality of anchor apertures 232 are disposed along the edge of the skirt 230 opposite the wire frame 222. The tether or pericardial anchor suture 280 is slidably inserted through the plurality of anchor apertures 232 in an alternating weave. The plurality of anchor apertures 232 may be disposed in a pattern or a random arrangement along the edge of the skirt 230. For example, the plurality of anchor apertures 232 may be arranged in a linear arrangement, a zigzag arrangement, or the like. A first end of the pericardial anchor suture 280 is configured to be fixedly coupled to the first end of the skirt 230 at the suture attachment portion 234. The suture attachment portion 234 may be a reinforced portion of the skirt 230, which, according to embodiments, is reinforced with additional material or a secondary material added to facilitate and strengthen bonding. In other embodiments, the reinforced portion may have different material properties, such as, but not limited to, a porous material that is pressure and / or heat densified. The suture attachment portion 234 may be located at a distal end or portion of the skirt 230, which advantageously improves deployment of the pericardial anchor 220 and allows tension retention of the pericardial anchor suture 280. According to embodiments, the suture attachment portion 234 at a distal end or portion of the skirt 230 cooperatively engages with the anchor aperture 232 of the skirt 230, distributing a predetermined amount of force along the skirt 230, compared to a more concentrated load at attachment points located more proximally 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, for example, by being within a fold or edge of the film or embedded within a layer of the film. This can improve the stability of the pericardial anchor 220 if the wire frame 222 is broken or damaged. The skirt 230 covering the wire frame 222 can further prevent the pericardial anchor sutures 280 from being misrouted or entangled in the wire frame 222, particularly during transition of the pericardial anchor 220 from a pre-deployment configuration (e.g., an elongated configuration) to a post-deployment configuration (e.g., a curved configuration).

[0143] In other embodiments, instead of weaving the pericardial anchor sutures 280 through the plurality of anchor apertures 232, the pericardial anchor sutures 280 can be incorporated into the skirt 230 in other ways, such as being integrated into the skirt 230 itself or being fixedly attached to or slidably received in a portion of the skirt 230. In some examples, the skirt 230 can include a tunnel or channel that slidably receives the pericardial anchor sutures 280.

[0144] In other embodiments, a biasing element can be integrated into or incorporated into skirt 230 instead of wire frame 222. The biasing element is operable to bias skirt 230 into a curved shape. According to one embodiment, the biasing element can be a densified, embossed, or treated portion of skirt 230 that is operable to bias pericardial anchor 220 to transform from a pre-deployment configuration to a post-deployment configuration, e.g., from an elongated configuration to a curved configuration.

[0145] 18 , tension can be applied to distal suture ends 315 of pericardial anchor sutures 280 extending through skirt 230 and / or proximal suture ends 317 of pericardial anchor sutures 280 to maintain pericardial anchor 220 in a straight configuration against the bias of wire frame 222 in the pre-deployment configuration. Pericardial anchor sutures 280 are operable to be tensioned to collapse skirt 230 into a curved, disk-shaped, or ring-shaped configuration when wire frame 222 is in the post-deployment configuration. Pericardial anchor sutures 280 are operable to collapse skirt 230 such that skirt 230 follows the curvature of wire frame 222 and completely covers the central portion defined by wire frame 222.

[0146] In some configurations, the wire frame 222 can be biased to form a helix when in a curved configuration in the deployed configuration. This helical bias can advantageously prevent the wire frame 222 from entangling with itself, other components of the fixation system, or the implant procedure site. The helical configuration can assist the pericardial anchor 220 in transforming into a coiled configuration. In some configurations, the wire frame 222 has a bias that conforms the pericardial anchor 220 to define a substantially planar disk when in the deployed configuration.

[0147] In other embodiments, instead of the coiled configuration shown in FIGS. 19 and 20 , the pericardial anchor 220 can transition from a pre-deployment configuration (e.g., an elongated configuration) suitable for pre-deployment, such as within a catheter, to a post-deployment configuration (e.g., a T-shaped, ring-shaped, coiled, curved, compressed, bundled, or padded configuration) in various ways. For example, the pericardial anchor 220 can begin to curve or coil starting from a free end of the pericardial anchor 220 to form a post-deployment shape, such as a disk-like shape. This free end can be the distal end of the pericardial anchor 220, which can be the distal end of both the pericardial anchor 220 and the pericardial fixation system 200. Possible coiling can be a partial coil forming a partial disk shape, a complete coil forming a complete disk shape, or overlapping coiling forming a complete disk shape. The disk-like shape can be low-profile so as not to significantly abut or interfere with the visceral pericardium. The size of the disk-like shape can be configured to be operable to prevent the pericardial anchor 220 from being pulled out of the delivery subsystem 400 or the pericardial anchor suture 280 through the myocardial puncture or channel and through the heart wall. The size of the disk-like shape can be configured to be operable to atraumatically distribute forces on the pericardial anchor 220 and the surrounding tissue it abuts due to tension on the remainder of the pericardial fixation 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, high-surface-area shape, which is advantageous for delivery and deployment of the pericardial anchor 220. The pericardial anchor 220, which defines a surface area within its disk-like shape, can promote tissue ingrowth and / or distribute loads on the pericardial fixation system 200 over a larger area of ​​the heart surface.

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

[0149] Transmyocardial pledget The pericardial fixation system 200 can include a transmyocardial pledget as disclosed in International Application No. PCT / US2020 / 032054 or International Application No. PCT / US2020 / 032168, which are incorporated herein by reference in their entireties, and various embodiments of the transmyocardial pledgets disclosed therein. The transmyocardial pledget 240 can be tubular, spherical, rectangular, etc. The transmyocardial pledget 240 can be used to expand the surface area of ​​the pledget suture 300.

[0150] FIG. 22 illustrates an exemplary embodiment of a transmyocardial pledget 240. The transmyocardial pledget 240 can include a pericardial anchor suture 280, a pledget suture 300, a compression element 310, and multiple pledget apertures 320 along the transmyocardial pledget 240. In some embodiments, the pericardial anchor suture 280 can be tensioned to collapse the pericardial anchor 220. In some embodiments, the pledget suture 300 can be tensioned to clamp the transmyocardial pledget 240. As described below, a compression element 310 can be integrated with the pledget suture 300 and can be used to transform the transmyocardial pledget 240 from a pre-clamped configuration to a post-clamped configuration. In some embodiments, the compression element 310 can be integrated with a first end 370 of the pledget suture 300. As shown in FIG. 22 , the transmyocardial pledget 240 can have a pre-clamped configuration. The transmyocardial pledget 240 can be in a pre-clamped configuration before tension is applied to the pledget suture 300. In some embodiments, the transmyocardial pledget 240 can form a post-clamped configuration when tension is applied to the second end 380 of the pledget suture 300, as described further below.

[0151] As shown in FIG. 22 , in some embodiments, the pledget suture 300 can extend through the transmyocardial pledget 240. The transmyocardial pledget 240 can include a plurality of pledget apertures 320. The pledget suture 300 can be woven through the plurality of pledget apertures 320. The plurality of pledget apertures 320 can have various sizes. The distance between each of the plurality of pledget apertures 320 can vary. In some embodiments, the distance between at least two of the plurality of pledget apertures 320 located at the proximal end 350 of the transmyocardial pledget 240 can be less than the distance between at least two of the plurality of pledget apertures 320 located at the intermediate portion 245 of the transmyocardial pledget 240. In some embodiments, the plurality of pledget apertures 320 can include a first set of apertures 330 and a second set of apertures 340. For example, the first set of apertures 330 can include at least one needle perforation, and the second set of apertures can include at least one biopsy hole. The first set of apertures 330 and the second set of apertures 340 can be disposed at the distal end 360 of the transmyocardial pledget 240. The first set of apertures 330 and the second set of apertures 340 can receive the pledget suture 300 so that it is woven through the multiple pledget apertures 320. In some embodiments, the first set of apertures 330 and the second set of apertures 340 can receive the first end 370 of the pledget suture 300 and the second end 380 of the pledget suture 300, respectively. In some embodiments, the first set of apertures 330 can be small enough, or have dimensions small enough, to prevent the compression elements 310 integral with the first end 370 of the pledget suture 300 from entering and / or passing through the first set of apertures 330. For example, the first set of apertures 330 can be slits or small holes that are smaller in size than the compression elements 310.

[0152] In some embodiments, the distance between the first set of apertures 330 and the second set of apertures 340 can be approximately 1 mm to 5 mm. In another embodiment, the distance between the first set of apertures 330 and the second set of apertures 340 can be approximately 3 mm. The distance between the first set of apertures 330 and the second set of apertures 340 can be long enough to help ensure that the compression element 310 integrated with the first end 370 of the pledget suture 300 cannot interact with the suture lock 270. In some embodiments, the first set of apertures 330 allows the compression element 310 to remain near the distal end 360 of the transmyocardial pledget 240 in the pre-clamped configuration of the transmyocardial pledget 240 and in the post-clamped configuration of the transmyocardial pledget 240. In other words, the first set of apertures 330 are sized to prevent the compression element 310 from entering and / or passing through the first set of apertures 330 before, during, and after the formation of the post-clamped configuration of the transmyocardial pledget 240.

[0153] FIG. 23 is a detailed view of the first set of apertures 330 of the transmyocardial pledget 240 in the pre-clamped configuration, as shown in FIG. 22. As shown in FIG. 23, the first set of apertures 330 define a dimension that is small enough to prevent the compression element 310 from entering and / or passing through the first set of apertures 330. As further shown in FIG. 23 and described above, the compression element 310 is disposed between the first set of apertures 330 and the anchor socket 260. In some embodiments, the compression element 310 is operable to engage and apply pressure to a surface of the transmyocardial pledget 240 to clamp or collapse the transmyocardial pledget 240, while remaining between the first set of apertures 330 and the anchor socket 260 as the transmyocardial pledget 240 clamps or collapses. The compression of the transmyocardial pledget 240 in response to pressure applied to the transmyocardial pledget 240 by the compression element 310 tensioning the pledget suture 300 is further described below.

[0154] Figure 24 is a detailed view of the first set of apertures 330 of the transmyocardial pledget 240 of Figure 22 in a clamped configuration. As shown in Figure 24, the first set of apertures 330 are small enough to prevent the compression elements 310 from slipping through the first set of apertures 330 when the compression elements 310 apply pressure to the transmyocardial pledget 240 by tensioning the pledget sutures 300 to clamp the transmyocardial pledget 240. As further shown in Figure 24, the compression elements 310 apply pressure to the surface of the transmyocardial pledget 240 and are operable to compress, fold, knead, bunch, etc. the transmyocardial pledget 240. For example, in one embodiment, compression element 310 is operable to apply pressure to transmyocardial pledget 240, compressing, folding, kneading, bunching, etc., transmyocardial pledget 240 to reduce the effective length or profile of transmyocardial pledget 240, which can result in a decrease in the distance between pericardial anchor 220 and anchor socket 260. In some embodiments, the pressure applied to transmyocardial pledget 240 by compression element 310 decreases the distance between pericardial anchor 220 and anchor socket 260. As further shown in FIG. 24 and described above, compression element 310 is between first set of apertures 330 and transmyocardial pledget 240 as transmyocardial pledget 240 transforms from the elongated configuration to the fastened configuration.

[0155] 25A-25B illustrate an exemplary embodiment of a suture path for a pledget suture 300 through a transmyocardial pledget 240. As shown in FIGS. 25A-25B, the pledget suture 300 can be woven through multiple pledget apertures 320 defined by the transmyocardial pledget 240, as shown in FIG. 22. In some embodiments, the first end 370 of the pledget suture 300 is woven through multiple pledget apertures 320 from the distal end 360 of the transmyocardial pledget 240 to the proximal end 350 of the transmyocardial pledget 240. The pledget suture 300 is woven through the same or different multiple pledget apertures 320 from the proximal end 350 of the transmyocardial pledget 240 to the distal end 360 of the transmyocardial pledget 240. This allows a first end 370 of the pledget suture 300 and a second end 380 of the pledget suture 300 to extend from the distal end 360 of the transmyocardial pledget 240. In some embodiments, the pledget suture 300 can be woven through the same plurality of pledget apertures 320 through which the pledget suture 300 passed from the distal end 360 of the transmyocardial pledget 240 to the proximal end 350 of the transmyocardial pledget 240, and then woven back from the proximal end 250 of the transmyocardial pledget 240 to the distal end 360 of the transmyocardial pledget 240. This allows for a uniform accordion fold or tightening of the transmyocardial pledget 240. In some embodiments, the pledget suture 300 can be woven from the proximal end 250 of the transmyocardial pledget 240 back to the distal end 360 of the transmyocardial pledget 240 through multiple pledget apertures 320 that are different from the multiple pledget apertures 320 through which the pledget suture 300 was woven from the distal end 360 of the transmyocardial pledget 240 to the proximal end 350 of the transmyocardial pledget 240. This can result in a non-uniform bunching or tightening of the transmyocardial pledget 240.

[0156] In some embodiments, the distal end 360 of the transmyocardial pledget 240 can be connected to the anchor socket 260. In some embodiments, the proximal end 350 of the transmyocardial pledget 240 can be connected to the pericardial anchor 220. For example, the pledget suture 300 can enter one of the pledget apertures 320 and exit the transmyocardial pledget 240 through a next one of the pledget apertures 320. In some embodiments, the pledget suture 300 can be woven through the pledget apertures 320 from the proximal end 350 of the transmyocardial pledget 240 to the distal end 360 of the transmyocardial pledget 240 after the pledget suture 300 has been woven through the pledget apertures 320 from the distal end 360 of the transmyocardial pledget 240 to the proximal end 350 of the transmyocardial pledget 240. In some embodiments, the pledget suture 300 can be threaded through the same multiple pledget apertures 320 in both a distal to proximal direction and a proximal to distal direction.

[0157] The more proximal or most proximal one of the pledget apertures 320 can be the aperture at which the pledget suture changes direction to weave in the opposite direction from the previous weaving through the multiple pledget apertures 320. The more proximal or most proximal one of the pledget apertures 320 can be the aperture of the multiple pledget apertures 320 that is furthest from the anchor socket 260. In other words, the more proximal or most proximal one of the multiple pledget apertures 320 can be positioned at the proximal end 350 of the transmyocardial pledget 240. In other words, the more proximal or most proximal one of the multiple pledget apertures 320 can be closest to the pericardial anchor 220.

[0158] 25A-25B, the pledget apertures 320 located at a proximal portion of the transmyocardial pledget 240 may be spaced closer together than the pledget apertures 320 located at a medial portion of the transmyocardial pledget 240. The closer distance between the pledget apertures 320 at the proximal portion of the transmyocardial pledget 240 may allow the pledget to bunch up inside the endocardium and substantially seal the tissue when the transmyocardial pledget 240 is transformed from the pre-clamped configuration to the post-clamped configuration. The relatively larger distance between each of the pledget apertures 320 located at a medial portion of the transmyocardial pledget 240 allows the transmyocardial pledget 240 to fold substantially flush with the endocardium when the transmyocardial pledget 240 is transformed from the pre-clamped configuration to the post-clamped configuration. It will be appreciated that the distance between the pledget apertures 320 will affect the folded or crimped configuration of the transmyocardial pledget 240 suitable for a particular purpose and can be varied along the length of the transmyocardial pledget 240. It will also be appreciated that the selection of the pledget apertures 320 across which the pledget suture 300 traverses will affect the folded or crimped configuration of the transmyocardial pledget 240 suitable for a particular purpose and / or the variation in tension felt by the user and can be varied along the length of the transmyocardial pledget 240.

[0159] In some embodiments, when the pledget suture 300 is woven in both directions through the plurality of pledget apertures 320, a first end 370 of the pledget suture 300 and a 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 remains between the first set of apertures 330 and the anchor sockets 260. The second end 380 of the pledget suture 300 can be a tail 385 extending through the anchor sockets 260, as shown in FIG. 22 , operable to apply tension to the tail 385 to tighten the transmyocardial pledget 240. In some embodiments, the compression element 310 does not engage a suture lock. In some embodiments, the second end 380 of the pledget suture 300 extends through the anchor socket 260 .

[0160] The pledget suture 300 can be threaded through the transmyocardial pledget 240 prior to loading the transmyocardial pledget 240 into a delivery system, as described above. The multiple pledget apertures 320 can be arranged in a random or patterned arrangement. For example, the pledget apertures 320 can be arranged in an arrangement suitable for a particular purpose, such as to impart a particular dimensional change to the transmyocardial pledget 240 in a compressed configuration, such as, but not limited to, a collinear arrangement, a zigzag arrangement, among others. The pledget suture 300 can be made from any suitable biocompatible material, such as, but not limited to, a fluoropolymer fiber.

[0161] FIG. 26 illustrates an exemplary embodiment of the transmyocardial pledget 240 in a post-clamped configuration. The transmyocardial pledget 240 can be transformed from the pre-clamped configuration of the transmyocardial pledget 240 to the post-clamped configuration of the transmyocardial pledget 240 by applying tension to the pledget suture 300 and the pericardial anchor 220. In some embodiments, the pledget suture 300 can transform the transmyocardial pledget 240 from a more straight or pre-clamped configuration, as shown in FIG. 22, to a post-clamped configuration, as shown in FIG. 26. For example, applying tension to the second end 380 of the pledget suture 300 can cause the compression element 310 located at the first end 370 of the pledget suture 300 to apply pressure to the surface of the transmyocardial pledget 240, causing the transmyocardial pledget 240 to pinch, compress, or fold like an accordion. For example, compression element 310 applies pressure to transmyocardial pledget 240, compressing, folding, crinkling, or otherwise constricting transmyocardial pledget 240, thereby reducing the effective length or profile shape of transmyocardial pledget 240. This reduces the distance between pericardial anchor 220 and anchor socket 260. Transmyocardial pledget 240 can incorporate pleats to facilitate folding during compression of transmyocardial pledget 240.

[0162] The transmyocardial pledget 240 can transition from a more straight, pre-clamped configuration to a curved or post-clamped configuration before or after the pericardial anchor 220 is fully deployed. For example, tensioning the pericardial anchor suture 280 can be used to curl or collapse the pericardial anchor 220 adjacent to and / or against the epicardium before tensioning the pledget suture 300 is used to transform the transmyocardial pledget 240 into the curved or post-clamped configuration. Similarly, in another embodiment, tensioning the pledget suture 300 can be used to deploy the t-bar adjacent to and / or against the epicardium before curling or collapsing the pericardial anchor 220 adjacent to and / or against the epicardium by tensioning the pericardial anchor suture 280 before transforming the transmyocardial pledget 240 into a compressed configuration. In this manner, the pledget suture 300 and the pericardial anchor suture 280 can operate independently. In other words, applying tension to pledget suture 300 does not affect the configuration of pericardial anchor 220 , and applying tension to pericardial anchor suture 280 does not affect the configuration of transmyocardial pledget 240 .

[0163] The transmyocardial pledget 240 can include a film including one or more layers. The film can be a fluoropolymer that can have tissue ingrowth properties. The film of the transmyocardial pledget 240 can have a tubular structure. The transmyocardial pledget 240 can include multiple pledget apertures 320 disposed along the length of the transmyocardial pledget 240. The pledget sutures 300 can be woven through or integrated into the film of the transmyocardial pledget 240, for example, but not limited to, between layers of the film forming a composite layup. As shown in FIGS. 18 and 19, the pledget sutures 300 can be woven through the film of the transmyocardial pledget 240 through multiple pledget apertures 320. The pledget sutures 300 enable the transmyocardial pledget 240 to be transformed from a straight configuration, as shown in FIG. 18, to a curved configuration, as shown in FIG. 20. For example, tensioning or retracting the pledget suture 300 can cause the material of the transmyocardial pledget 240 to compress or fold in an accordion-like manner. The transmyocardial pledget 240 can incorporate pleats to facilitate folding during deployment of the transmyocardial pledget 240. The transmyocardial pledget 240 can transition from a more straight configuration to a curved configuration before or after deployment of the pericardial anchor.

[0164] The transmyocardial pledget 240 can further include a compression element 310 that can be disposed on the first end 370 of the pledget suture 300. The compression element 310 can be used to clamp the transmyocardial pledget 240 or to assist in transforming the transmyocardial pledget 240 from a pre-clamped configuration to a post-clamped configuration. The compression element 310 can be a separate element coupled to the first end 370 of the pledget suture 300, or can be a unitary element defined by the first end 370 of the pledget suture 300. In some embodiments, for example, the compression element 310 can include a knot. In other embodiments, for example, the compression element 310 can be a ring to which the first end 370 of the pledget suture 300 is coupled. In some embodiments, the second end 380 of the suture is threaded and slidably received within the compression element 310, allowing for sliding engagement therebetween. Tension applied to the second end 380 of the pledget suture 300 is operable to apply pressure to the surface of the transmyocardial pledget 240 by translating the compression element 310 along the second end 380 of the pledget suture 300 and forcing the compression element 310 into engagement with the transmyocardial pledget 240. This causes the transmyocardial pledget 240 to pinch, fold, roll, and / or reduce in effective length and expand in perimeter, i.e., transverse to the longitudinal axis of the transmyocardial pledget 240, thereby occluding, sealing, or filling the intramyocardial space or channel through which the transmyocardial pledget 240 passes.

[0165] In other embodiments, the second end 380 of the suture is not threaded through the compression element 310. Tension applied to the second end 380 of the pledget suture 300 is operable to translate the compression element 310 to the first set of apertures 330, forcing the compression element 310 into engagement with the transmyocardial pledget 240, thereby applying pressure to the surface of the transmyocardial pledget 240. This causes the transmyocardial pledget 240 to pinch, fold, roll, and / or reduce its effective length and expand in perimeter, i.e., transverse to the longitudinal axis of the transmyocardial pledget 240, thereby occluding, sealing, or filling the intramyocardial space or channel through which the transmyocardial pledget 240 passes.

[0166] The compression element 310 can clamp the transmyocardial pledget 240 from the distal end 360 of the transmyocardial pledget 240 to the proximal end 350 of the transmyocardial pledget 240. Pressure applied to the compression element 310 can collapse the transmyocardial pledget 240. For example, the compression element 310 can translate to the first set of apertures 330, thereby causing the compression element 310 to apply pressure to the surface of the transmyocardial pledget 240. In some embodiments, tension can be applied to the second end 380 of the pledget suture 300 in a second direction 390, thereby causing the compression element 310 to translate along the pledget suture 300, applying pressure to the surface of the transmyocardial pledget 240 and transitioning the transmyocardial pledget 240 to the clamped configuration. The second direction 390 can be away from the pericardial anchor 220 and / or the t-bar 290.

[0167] In some embodiments, translational movement of the compression element 310 can secure the transmyocardial pledget 240 in the collapsed or clamped configuration. The transmyocardial pledget 240 can remain secured in the clamped configuration by, for example, but not limited to, motion resistance or friction between the pledget suture 300 and the plurality of pledget apertures 320. In some embodiments, a predetermined resistance between the pledget suture 300 and the plurality of pledget apertures 320 can secure the transmyocardial pledget 240 in the clamped configuration, as shown in FIG. 24 . In some embodiments, a second predetermined resistance between the compression element 310 and the first end 370 of the pledget suture 300 can also maintain the transmyocardial pledget 240 in the clamped configuration, as shown in FIG. 24 . In some embodiments, a combination of the predetermined resistance and the second predetermined resistance can maintain the transmyocardial pledget 240 in the clamped configuration, as shown in FIG. 24 . In some embodiments, the compression element 310 can translate to a new position or return to its original position without affecting the configuration of the transmyocardial pledget 240. This allows for no tension on the pledget suture 300 or minimal tension on the pledget suture 300 when the transmyocardial pledget 240 is in the post-cinched configuration. In other words, after the transmyocardial pledget 240 reaches its collapsed configuration, slack can be provided to the pledget suture 300 while maintaining the collapsed configuration. Any subsequent tension applied to the pledget suture 300 can be independent of or have minimal effect on the configuration of the transmyocardial pledget 240. This allows the pericardial anchor suture 280 and the pledget suture 300 to operate independently of one another.

[0168] In other embodiments, the pledget suture 300 can be maintained under a predetermined resistance when the transmyocardial pledget 240 is in the collapsed configuration. In some embodiments, a predetermined tension can be applied to the second end 380 of the pledget suture 300, which can cinch the transmyocardial pledget 240. This creates a predetermined resistance between the pledget suture 300 and the transmyocardial pledget 240, allowing the transmyocardial pledget 240 to maintain its post-cinched configuration. In some embodiments, the predetermined tension can be between approximately 0.5N and 3N. In some embodiments, the predetermined tension can be between approximately 1N and 2N.

[0169] In some embodiments, the translational movement of the compression element 310 is operable to apply pressure to the surface of the transmyocardial pledget 240, thereby assisting in holding or maintaining the transmyocardial pledget 240 in a clamped or collapsed configuration. This allows the transmyocardial pledget 240 to have an adjustable configuration. In this manner, the transmyocardial pledget 240 is not fixed in a single configuration, but rather is adjustable throughout the mitral valve repair procedure. For example, the configuration of the transmyocardial pledget 240 can be adjusted during, before, or after the securement of the leaflet anchor sutures, as described below.

[0170] FIG. 27A illustrates an exemplary embodiment of a pledget suture 300. As shown in FIG. 27A, the pledget suture 300 is in the form of a distinct loop secured by a knot and defines a compression element 310 as an integral component to the pledget suture 300. The compression element 310 is disposed at a first end of the pledget suture 300. The compression element 310 can be a knot, a slip knot, or a slip loop knot, and can be used to apply pressure to the surface of the transmyocardial pledget 240 to transform the transmyocardial pledget 240 from a pre-clamped configuration to a post-clamped configuration. The compression element 310 can be disposed at a fixed length at a first end 370 of the pledget suture 300. A second end 380 of the pledget suture 300 can remain extended or elongated to allow tension to be applied to the second end 380 of the pledget suture 300. In some embodiments, tension can be applied to the second end 380 of the pledget suture 300, causing the compression element 310 to translate along the pledget suture 300 and be operable to apply pressure to the surface of the transmyocardial pledget 240. In some embodiments in which the second end 380 of the pledget suture 300 is slidably received by the compression element 310, the compression element 310 does not tighten around the second end 380 of the pledget suture 300, causing the first end 370 of the pledget suture 300 to not change in length and / or diameter when formed as a loop when tension is applied to the second end 380 of the pledget suture 300. In some embodiments, tension applied to the second end 380 of the pledget suture 300 can be applied in a second direction 405. For example, the second direction 405 can be a direction away from the pericardial anchor. This allows the compression element 310 to translate along the pledget suture 300 in a first direction 410 opposite the second direction 405. In some embodiments, when tension is applied to the second end 380 of the pledget suture 300 in the second direction 405, the compression element 310 translates along the pledget suture 300 in the first direction 410. The first direction 410 can be toward the pericardial anchor.

[0171] FIG. 27B illustrates an exemplary embodiment of a compression element 310. As shown in FIG. 27B, the compression element 310 can be a non-slip loop knot. The compression element 310 can be disposed on a fixed length of the first end 370 of the pledget suture 300. In some embodiments, the compression element 310 can include a knot 312 and a loop 314. In this manner, the loop 314 of the compression element 310 is locked or secured, thereby allowing the first end 370 of the pledget suture 300, integrated with the compression element 310, to move substantially freely along the second end 380 of the pledget suture 300 and not be under tension or secured, thereby providing sliding reception. In some embodiments, the knot 312 can be a washer, an O-ring, or the like. In some embodiments, the knot 312 can be large enough to prevent the compression element 310 from entering the first set of apertures 330.

[0172] FIG. 28 illustrates an exemplary embodiment of a pericardial fixation system 200 deployed in a flat configuration. The pericardial fixation 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 orthogonal to one another. The proximal end of the transmyocardial pledget 240 can be connected to the proximal end of the pericardial anchor 220 in an orthogonal configuration. In some embodiments, the pericardial fixation system 200 can further include a pericardial anchor suture 280 and a pledget suture 300. The pledget suture 300 can be woven through multiple pledget apertures 320 located on the transmyocardial pledget 240. The multiple pledget apertures 320 can be arranged in a random arrangement, a linear arrangement, a pattern arrangement, etc. In some embodiments, the multiple pledget apertures can be evenly spaced from one another. In other embodiments, the multiple pledget apertures 320 can have different spacings from one another. In some embodiments, at least some of the pledget apertures 320 located at a proximal portion of the transmyocardial pledget 240 can have a closer distance between each other than at least some of the pledget apertures 320 located at an intermediate portion of the transmyocardial pledget 240. In some embodiments, at least some of the pledget apertures 320 located at a distal portion of the transmyocardial pledget 240 can have a closer spacing between each other than at least some of the pledget apertures 320 located at an intermediate portion of the transmyocardial pledget 240. For example, a first distance between a first aperture of the plurality of pledget apertures and a second aperture of the plurality of apertures can be smaller than a second distance between a second aperture of the plurality of apertures and a third aperture of the plurality of apertures. In some embodiments, the configuration and / or arrangement of the plurality of pledget apertures 320 can determine how the transmyocardial pledget 240 transforms from a pre-clamped configuration to a post-clamped configuration. For example, multiple pledget apertures located proximally of the transmyocardial pledget 240 allow for compact packing of the transmyocardial pledget 240 .In another example, multiple pledget apertures located in the middle of the transmyocardial pledget 240 allow the transmyocardial pledget 240 to fold or fold evenly.

[0173] The pledget suture 300 can be woven through some or each of the multiple pledget apertures 320. In some embodiments, the pledget suture 300 can be woven multiple times through some or each of the multiple pledget apertures 320. For example, the pledget suture 300 can be woven through some or each of the multiple pledget apertures 320 from the distal end 360 of the transmyocardial pledget 240 to the proximal end 350 of the transmyocardial pledget 240. Once the pledget suture 300 is woven through one of the pledget apertures 320 near or closest to the proximal end 350 of the transmyocardial pledget 240, the pledget suture 300 can reverse direction and be woven through some or each of the multiple pledget apertures 320 from the proximal end 350 of the transmyocardial pledget 240 to the distal end 360 of the transmyocardial pledget 240. In an embodiment in which the pledget suture 300 is woven sequentially through each of the plurality of pledget apertures 320 from the distal end 360 of the transmyocardial pledget 240 to the proximal end 350 of the transmyocardial pledget 240, and then woven through the same respective plurality of pledget apertures 320 from the proximal end 350 of the transmyocardial pledget 240 back to the distal end 360 of the transmyocardial pledget 240, the transmyocardial pledget 240 can be compressed in an accordion-like manner to provide a predetermined profile that affects sealing engagement with the endocardial or intramyocardial channel. According to another embodiment in which the pledget suture 300 is woven sequentially through each of a plurality of pledget apertures 320 from the distal end 360 of the transmyocardial pledget 240 to the proximal end 350 of the transmyocardial pledget 240, and then woven through a different pledget aperture 320 from the proximal end 350 of the transmyocardial pledget 240 back to the distal end 360 of the transmyocardial pledget 240, the transmyocardial pledget 240 can be compressed in a more chaotic bundled manner as compared to an accordion-like manner, providing a predetermined profile that influences sealing engagement with the endocardial or intramyocardial channel.

[0174] In some embodiments, the pericardial anchor suture 280 can be woven through some, none, or at least two of the multiple pledget apertures 320. This allows the pericardial anchor suture 280 connected to the pericardial anchor 220 to be woven through multiple anchor apertures 232 disposed on the pericardial anchor. For example, the pericardial anchor suture 280 can be woven through the proximal pledget aperture 320 disposed 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 multiple anchor apertures 232 disposed on the pericardial anchor. This allows tension to be applied to the pericardial anchor suture 280 to deploy the pericardial anchor 220, as described above, without affecting the configuration of the transmyocardial pledget 240. In this manner, the pericardial anchor suture 280 and the pledget suture 300 can operate independently. In some embodiments, the pericardial anchor sutures 280 can be woven through a second set of apertures (not shown) located on the transmyocardial pledget 240. In some embodiments, the pericardial anchor 220 can be deployed to form, for example, a disk shape. In some embodiments, the pericardial anchor sutures 280 can extend beyond the distal end 360 of the transmyocardial pledget 240, allowing the pericardial anchor sutures 280 access to tension.

[0175] In some embodiments, the pericardial anchor suture 280 can be tensioned before the pledget suture 300 is tensioned. For example, the pericardial anchor 220 can be deployed (e.g., form a disk shape) before the transmyocardial pledget 240 is transformed from the pre-clamped configuration to the post-clamped configuration. In other embodiments, the pledget suture 300 can be tensioned before the pericardial anchor suture 280 is tensioned. For example, the pledget suture 300 can be transformed from the pre-clamped configuration to the post-clamped configuration before the pericardial anchor is 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 transformed from the pre-clamped configuration to the post-clamped configuration at the same time or similar to when the pericardial anchor 220 is deployed.

[0176] FIG. 29 shows an isometric view of an exemplary embodiment of a transmyocardial pledget 240. As shown in FIG. 29 , 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. A first end 370 of the pledget suture 300 and a second end 380 of the pledget suture 300 can also extend beyond the distal end of the pledget. In some embodiments, tension is applied to the second end of the pledget suture 300, which can cause a compression element 310 located at the first end 370 of the pledget suture 300 to apply pressure to the surface of the transmyocardial pledget 240, which can collapse or deform the transmyocardial pledget 240 into a fastened configuration. In some embodiments, as the compression element 310 applies pressure to the surface of the transmyocardial pledget 240, the transmyocardial pledget 240 collapses or deforms into the clamped configuration. As shown in FIG. 29 , the compression element 310 can be larger in size and diameter than at least one of the plurality of pledget apertures 320. For example, the compression element 310 can be larger in size and / or diameter than the first set of apertures 330. This prevents the compression element 310 from entering the plurality of pledget apertures 320 and allows the transmyocardial pledget 240 to form the clamped 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 fixation system.

[0177] 30 shows a top view of an exemplary embodiment of a transmyocardial pledget 240. As shown in FIG. 30, the compression element 310 integrated with the pledget suture 300 can have a diameter larger than the size of the first set of apertures 330. This prevents the compression element 310 from entering multiple pledget apertures 320 and allows the transmyocardial pledget 240 to form a clamped configuration.

[0178] 31A-31D illustrate an exemplary embodiment of the compression element 310. As shown in FIGS. 31A-31D, the compression element 310 can include a compression fit sleeve 420. The compression fit sleeve 420 can be silicone, oPTFE, PTFE, or the like. FIG. 31A illustrates a top view of the transmyocardial pledget 240 including the compression fit sleeve 420. FIG. 31B illustrates a side view of the transmyocardial pledget 240 including the compression fit sleeve 420. FIG. 31C illustrates an isometric view of the transmyocardial pledget 240 including the compression fit sleeve 420. FIG. 31D illustrates a close-up view of the compression fit sleeve 420. As shown in FIG. 31A, the compression fit sleeve 420 can be larger in size than the multiple pledget apertures 320. This prevents the compression fit sleeve 420 from entering the multiple pledget apertures 320 and allows the transmyocardial pledget 240 to form a fastened configuration. In some embodiments, the pledget suture 300 can be threaded through a compression fit sleeve 420 .

[0179] 32A-32D illustrate an exemplary embodiment of the compression element 310. As shown in FIGS. 32A-32D, the compression element 310 can include a small pledget 430. The small pledget 430 can be silicone, oPTFE, PTFE, or the like. FIG. 32A illustrates a top view of a transmyocardial pledget 240 including the small pledget 430. FIG. 32B illustrates a side view of the pledget including the small pledget 430. FIG. 32C illustrates an isometric view of the transmyocardial pledget 240 including the small pledget 430. FIG. 32D illustrates a close-up view of the small pledget 430. As shown in FIG. 32A, the small pledget 430 can be larger in size than the multiple pledget apertures 320. This prevents the small pledget 430 from entering the multiple pledget apertures 320 and allows the pledget to form a clamped configuration. In some embodiments, the pledget suture 300 can be threaded through the small pledget 430. In some embodiments, when tension is applied to the small pledgets 430, the small pledgets 430 can be stretched.

[0180] 33A-33D illustrate exemplary embodiments of arrangements of the multiple small pledget apertures 440. The multiple small pledget apertures 440 can be arranged in a random or patterned arrangement. For example, the multiple small pledget apertures 440 can be arranged in a zigzag, straight, curved, or diagonal arrangement. As shown in FIGS. 33A, 33B, and 33C, the multiple small pledget apertures 440 can be arranged in a zigzag pattern. The multiple small pledget apertures 440 can be offset from the center of the small pledget 430. The zigzag arrangement of the multiple small pledget apertures 440 can cause the small pledget 430 to torsionally collapse or pinch when tension is applied to the pledget suture 300. This can provide additional resistance between the small pledgets 430 and the pledget suture 300 before the transmyocardial pledget 240 is fully transformed into the pinched configuration.

[0181] Deployment of pericardial fixation systems The pericardial fixation system may be deployed, for example, in a mitral valve leaflet repair procedure. To deploy the pericardial fixation system 200, in some embodiments, tension may be applied to the pericardial anchor suture 280, which may be woven through the pericardial anchor 220. This may deploy the pericardial anchor 220. For example, the pericardial anchor suture 280 may be deployed into a disk shape. In some embodiments, tension may be applied to the second end 380 of the pledget suture 300, which may cause the compression element 310 to apply pressure to the surface of the transmyocardial pledget 240 in the pre-clamped configuration. This may transform the transmyocardial pledget 240 from the pre-clamped configuration to the post-clamped configuration. For example, tension may be applied to the second end 380 of the pledget suture 300 in a direction away from or away from the pericardial anchor 220. The compression element 310 may then apply pressure to the surface of the transmyocardial pledget 240 in a direction toward the pericardial anchor 220, deforming the transmyocardial pledget 240 into the clamped configuration. The transmyocardial pledget 240 may be secured in the clamped configuration. This may be because a predetermined resistance between the pledget suture 300 and the transmyocardial pledget 240 may stabilize or secure the transmyocardial pledget 240 in the clamped configuration. Once the transmyocardial pledget 240 is locked, the compression element 310 may translate to a new or original position without affecting the configuration of the transmyocardial pledget 240. This may leave the pledget suture 300 in a relaxed, untensioned, or minimally tensioned state. The second end 380 of the pledget suture 300 and the pericardial anchor suture 280 may then be threaded through a suture lock 270 in an anchor socket 260, which may be connected to the transmyocardial pledget 240. In some embodiments, the transmyocardial pledget 240 can be transformed from a pre-clamped configuration to a post-clamped configuration prior to deploying the pericardial anchor 220 .

[0182] Suture lock The pericardial fixation system 200 can further include an anchor socket 260 capable of holding a suture lock 270. The pericardial fixation system 200 can include a suture lock as disclosed in U.S. Patent No. 9,877,833. The pericardial fixation 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 (each of which is incorporated by reference in its entirety), as well as various embodiments of the suture lock or socket disclosed therein. The pericardial fixation system 200 can include a socket as disclosed in U.S. Application No. 16 / 710,637 (each of which is incorporated by reference in its entirety), as well as various embodiments of the suture lock or socket disclosed therein. The suture lock 270 can be used to secure each of the pericardial anchor suture 280 and the leaflet anchor suture 310A. Suture lock 270 can also be used to tension and adjust the length of each of pericardial anchor suture 280 and leaflet anchor suture 310A. Once the lengths have been optimized to provide the proper tension for the mitral chordae repair, suture lock 270 can be locked to fix the lengths of each of pericardial anchor suture 280 and leaflet anchor suture 310A.

[0183] socket As used herein, the term "socket" includes and may be used interchangeably with the following terms: cover, receptacle, shroud, coupler, constraint, retaining member, etc. According to one embodiment, the anchor socket 260 can have a tubular structure that can receive and at least partially cover the suture lock 270. The anchor socket 260 can include a self-expanding frame that can minimize the profile of the anchor socket 260 when in a pre-deployed configuration on a delivery system. The self-expanding frame can be a nitinol stent frame. The anchor socket 260 can have a length that exceeds the length of the suture lock 270, ensuring that the anchor socket 260 completely covers the suture lock 270. The anchor socket 260 can be a retaining member for restraining movement of the suture lock relative to the rest of the pericardial fixation system 200 and movement of the suture relative to the suture lock 270. The anchor socket 260 can also be referred to as a suture lock guide, socket, or sleeve. The anchor socket 260 can reduce wear and secure tension on the pericardial anchor suture 280 and the leaflet anchor suture 310A, respectively. The anchor socket 260 can couple the pericardial fixation system 200 with a suture lock.

[0184] Deployed fastening system 34 illustrates an example of a pericardial fixation system 200 deployed in a cardiac ventricle and partially implanted in place. As shown, a ring-shaped pericardial anchor 220 is positioned within the pericardial cavity. The pericardial anchor 220 secures the pericardial fixation system 200 and serves as a mechanical interface for securing the pericardial fixation system 200. The pericardial anchor 220 also serves to seal one end of the myocardial puncture. A transmyocardial pledget 240 extends from the pericardial anchor 220, passing partially through the heart wall 41 and partially folded against the endocardial layer of the heart wall 41. A suture lock 270 disposed within the anchor socket 260 can be positioned against the folded portion of the transmyocardial pledget 240. The suture lock 270, enclosed within the anchor socket 260, can deliver the anchor socket 260 to the endocardial surface, which may also facilitate sealing of the puncture on the endocardial surface by the folded portion of the transmyocardial pledget 240. The pericardial anchor suture 280 can extend through the pericardial anchor 220, the transmyocardial pledget 240, and into the suture lock 270. The pericardial anchor suture 280 also functions as a tensioning member for forming the pericardial anchor 220. The pericardial anchor suture 280 can provide a rail for connecting the suture lock 270. The transmyocardial pledget 240 can protect the heart wall 41 from damage caused by the pericardial anchor suture 280. The transmyocardial pledget 240 adds bulk to the pericardial anchor suture 280. The pericardial anchor suture 280 itself may have a tendency to cut or slice the myocardium upon application of tension or load. The transmyocardial pledget 240 prevents the pericardial anchor sutures 280 from migrating into the myocardium. The transmyocardial pledget 240 can form a myocardial seal by blocking a channel or puncture through the heart wall 41 and folding over to seal the opposite end of the puncture on the endocardial surface. For example, the transmyocardial pledget 240 can be clamped or collapsed so that the t-bar 290 engages the epicardium, thereby sealing the epicardial channel or puncture during the process of deploying the pericardial fixation system 200 across the heart wall.In another example, the transmyocardial pledget 240 can be clamped or collapsed to crush or press the transmyocardial pledget 240 against the endocardium during the process of deploying the pericardial fixation system 200 across the heart wall. In some embodiments, the transmyocardial pledget 240, when in the clamped configuration, can be flush against the endocardium during the process of deploying the pericardial fixation system 200 across the heart wall, thereby sealing a channel or perforation in the endocardium. In another example, the transmyocardial pledget 240 can be clamped or collapsed during the process of deploying the pericardial fixation system 200 across the heart wall, resulting in a transverse or longitudinal expansion of the girth of the transmyocardial pledget 240, thereby sealing a channel or perforation through the myocardium. In another example, any combination of modes of sealing a perforation or channel in the heart wall during the process of deploying the pericardial fixation system 200 across the heart wall, as described above, is contemplated.

[0185] The pledget aperture distance, i.e., the distance between one of the plurality of pledget apertures and the next pledget aperture, can contribute to the clamping of the transmyocardial pledget. For example, the pledget distance between at least two of the plurality of pledget apertures can be greater than a maximum transverse dimension of the transmyocardial pledget 240, such that the transmyocardial pledget 240, when tensioned at the second end 380 of the pledget suture 300, is operable to collapse the transmyocardial pledget 240 to an expanded or greater transverse dimension when in the clamped configuration relative to the maximum transverse dimension of the transmyocardial pledget 240 when in the elongated or pre-clamped configuration. The expanded dimension can be greater than the shortened transverse dimension of the transmyocardial pledge when in the elongated or pre-clamped configuration. Similarly, for example, the pledget aperture spacing between at least two pledget apertures may be greater than twice the maximum transverse dimension of the transmyocardial pledget, such that the transmyocardial pledge, when tensioned at the second end 380 of the pledget suture 300, is operable to fold the transmyocardial pledge 240 to a larger transverse dimension when in the clamped configuration relative to the maximum transverse dimension of the transmyocardial pledge 240 when in the elongated configuration, thereby folding the transmyocardial pledge 240 in half. Further, as shown in FIG. 28 , for example, the multiple pledget apertures 320 may not be collinear along the longitudinal direction 247 of the transmyocardial pledge 240, such that the transmyocardial pledge 240, when tensioned at the second end 380 of the pledget suture 300, is operable to fold the transmyocardial pledge 240 to a larger transverse dimension when in the clamped configuration relative to the maximum transverse dimension of the transmyocardial pledge 240 when in the elongated configuration.

[0186] The suture lock 270 can also capture the leaflet anchor suture 310A, which can extend between the leaflet anchor 300A implanted in the mitral valve leaflet 9 and the suture lock 270 to repair the mitral chordae.

[0187] Implanted leaflet anchor FIG. 35A illustrates an example of a leaflet anchor implanted in a valve leaflet and a leaflet anchor suture 310A extending between the leaflet anchor 300A and a pericardial fixation system 200 implanted in at least the ventricular wall. As shown, the pericardial fixation system 200 is implanted in the ventricular wall and positioned such that the anchor socket 260 faces the endocardial surface of the heart wall 4s. The leaflet anchor 300A can be an anchor configured so that at least a portion of the anchor is positioned within or on the leaflet. At least a portion of the pericardial anchor 220 can be embedded within or contact the tissue of the leaflet. The leaflet anchor 300A can have various shapes, such as a pledget, clip, or hook. The leaflet anchor suture 310A can extend from a suture lock 270 positioned in the anchor socket 260 to the leaflet anchor 300A. The leaflet anchor 300A can be an anchor positioned within the mitral valve leaflet 9. Leaflet anchor 300A can be a pledget.

[0188] 35B is a cross-sectional view of a ventricular wall in which a ventricular fixation system has been implanted. As shown, a pericardial anchor 220 can be positioned within the pericardial cavity 10. A transmyocardial pledget 240 can extend from the pericardial anchor 220 through the endocardial, myocardial, and epicardial punctures. The transmyocardial pledget 240 can also be folded against the endocardial surface of the heart wall 41. An anchor socket 260 can be positioned against the endocardium of the heart wall 41.

[0189] FIG. 35C is a diagram of pericardial anchor 220 implanted within the pericardial space.

[0190] Leaflet Fixation System According to one embodiment, the pericardial fixation system 200 can be used to control the movement of the mitral valve leaflets by coupling the pericardial anchor sutures 280 to one or more leaflet anchor sutures 310A (also referred to as tethers) that are themselves coupled to the mitral valve leaflets 9. After the pericardial anchor 220 and transmyocardial pledget 240 are delivered to the target site, the pericardial anchor sutures 280 can be coupled to a suture lock and coupled to the mitral valve leaflets 9 using a leaflet fixation system 510. The leaflet fixation system 510 includes a leaflet anchor 300A and a leaflet anchor suture 310A operable to pass through and couple to the mitral valve leaflet 9. In some embodiments, the leaflet anchors can be delivered to the mitral valve prior to delivery of the pericardial fixation system. In some embodiments, the leaflet anchor sutures 310A can be coupled to the mitral valve leaflets 9 before the leaflet anchor sutures 310A are coupled to the pericardial anchor sutures 280 and / or the pledget sutures.

Claims

1. pericardial anchor, a transmyocardial pledget extending from the proximal end of the pericardial anchor; and a transmyocardial pledget suture coupled to the transmyocardial pledget, the transmyocardial pledget suture operable, upon application of tension to an end of the transmyocardial pledget suture, to deform the transmyocardial pledget from an elongated configuration to a post-cinched configuration defining a longitudinally shortened dimension; 1. A pericardial fixation system comprising:

2. 2. The pericardial fixation system of claim 1, wherein the transmyocardial pledget suture is operable to deform the transmyocardial pledget from an elongated configuration to a post-fastened configuration defining an enlarged transverse longitudinal dimension when tension is applied to an end of the transmyocardial pledget suture.

3. 3. The pericardial fixation system of claim 1, wherein the transmyocardial pledget includes a plurality of pledget apertures disposed along the length of the transmyocardial pledget, and the transmyocardial pledget suture extends sequentially through the plurality of pledget apertures.

4. 4. The pericardial fixation system of claim 3, wherein the transmyocardial pledget sutures are woven sequentially through the plurality of pledget apertures and sequentially positioned adjacent a first side of the transmyocardial pledget and a second side of the transmyocardial pledget opposite the first side of the transmyocardial pledget.

5. 5. The pericardial fixation system of claim 3, wherein the transmyocardial pledget suture traverses sequentially through the plurality of pledget apertures from the distal end of the transmyocardial pledget to the proximal end of the transmyocardial pledget and returns to the distal end of the transmyocardial pledget, the proximal end of the transmyocardial pledget being adjacent to the pericardial anchor.

6. 6. The pericardial fixation system of claim 3, wherein the transmyocardial pledget suture includes a first end of the transmyocardial pledget suture and a second end of the transmyocardial pledget suture opposite the first end of the transmyocardial pledget suture, the first end of the transmyocardial pledget suture including a compression element, the compression element having dimensions that prevent the compression element from passing through a first aperture of a plurality of pledget apertures, and the compression element is operable to engage and compress the transmyocardial pledget when tension is applied to the second end of the transmyocardial pledget suture.

7. The pericardial fixation system of claim 6 , wherein the compression element is a knot defined by a first end of the transmyocardial pledget suture.

8. The pericardial fixation system of claim 6 or 7, wherein the compression element is configured to translate along the second end of the transmyocardial pledget suture.

9. 7. The pericardial fixation system of claim 6, wherein the compression element is a first end of the transmyocardial pledget suture defining a knot and a loop operable to slidably receive a second end of the transmyocardial pledget suture.

10. 7. The pericardial fixation system of claim 6, wherein the compression element is a loop coupled to a first end of the transmyocardial pledget suture, and a second end of the transmyocardial pledget suture is slidably received therethrough.

11. The pericardial fixation system of claim 10 , wherein the loop is a ring.

12. The pericardial fixation system of any one of claims 8 to 11, configured to tighten the transmyocardial pledget by translating the compression element along the second end of the transmyocardial pledget suture in a direction toward the pericardial anchor.

13. The pericardial fixation system of any one of claims 8 to 12, further comprising a suture tail integral with or coupled to the compression element, wherein application of tension to the suture tail in a direction away from the pericardial anchor causes the transmyocardial pledget suture to detach from the transmyocardial pledget, and the transmyocardial pledget suture to slide out of the plurality of pledget apertures and detach.

14. 13. The pericardial fixation system of any one of claims 2 to 12, wherein a pledget aperture distance between at least two pledget apertures is greater than a maximum transverse dimension of the transmyocardial pledget, and wherein the transmyocardial pledget is operable, when tension is applied to the second end of the transmyocardial pledge suture, to collapse the transmyocardial pledge to a larger transverse dimension in a tightened configuration relative to the maximum transverse dimension of the pledget in an elongated configuration.

15. 15. The pericardial fixation system of claim 2, wherein a pledget aperture distance between at least two pledget apertures is greater than twice the maximum transverse dimension of the transmyocardial pledget, and wherein the transmyocardial pledget is operable, when tension is applied to the second end of the transmyocardial pledge suture, to collapse the transmyocardial pledge to a larger transverse dimension in the tightened configuration relative to the maximum transverse dimension of the pledget in the elongated configuration.

16. 16. The pericardial fixation system of claim 2, wherein the plurality of pledget apertures are not aligned in a straight line along the length of the transmyocardial pledget, and the transmyocardial pledget is operable, when tension is applied to the second end of the transmyocardial pledge suture, to collapse the transmyocardial pledge to a larger transverse dimension in a tightened configuration relative to the maximum transverse dimension of the transmyocardial pledge in an elongated configuration.

17. 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 receive the suture lock; The pericardial fixation system according to any one of claims 1 to 16, further comprising:

18. 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 attached to the transmyocardial pledget; a suture lock configured to interact with the pericardial anchor suture; and an anchor socket configured to receive the suture lock; Including, the pericardial anchor is operable to be transformable between a pre-deployment configuration and a post-deployment configuration; the transmyocardial pledget is operable to be transformable between a pre-clamped configuration and a post-clamped configuration; A pericardial fixation system, wherein the transmyocardial pledget and the pericardial anchor are independently operable.

19. The pericardial fixation system of claim 18 , wherein the anchor socket is further configured to restrain and dock the suture lock.

20. The pericardial fixation system of claim 18 , wherein the suture lock secures the pericardial anchor suture.

21. 20. The pericardial fixation system of claim 18, wherein the transmyocardial pledget includes a plurality of apertures disposed along the length of the transmyocardial pledget.

22. 22. The pericardial fixation system of claim 21, wherein the transmyocardial pledget sutures are woven through the plurality of apertures.

23. 22. The pericardial fixation system of claim 21, wherein the transmyocardial pledget suture is woven through the plurality of apertures from the distal end to the proximal end and back to the distal end.

24. 20. The pericardial fixation system of claim 18, wherein the transmyocardial pledgets are configured to form a clamped shape, bundle, or mass in a post-clamped configuration.

25. The pericardial fixation system of claim 18 , wherein the transmyocardial pledget suture includes a compression element.

26. 26. The pericardial fixation system of claim 25, wherein the compression element is configured to translate along the transmyocardial pledget suture.

27. 26. The pericardial fixation system of claim 25, wherein the compression element is configured to translate along the second end of the transmyocardial pledget suture.

28. 26. The pericardial fixation system of claim 25, wherein a first end of the transmyocardial pledget suture is slidably received through the compression element operable to translate along a second end of the transmyocardial pledget suture.

29. 27. The pericardial fixation system of claim 26, wherein translating the compression element along the transmyocardial pledget suture in a direction toward the pericardial anchor is configured to tighten the transmyocardial pledget.

30. 26. The pericardial fixation system of claim 25, wherein the compression element is a non-slip loop knot.

31. 26. The pericardial fixation system of claim 25, wherein the compression element applies pressure to a surface of the transmyocardial pledget to deform the transmyocardial pledget into a post-fastening configuration.

32. 32. The pericardial fixation system of claim 31, wherein minimal tension is applied to the transmyocardial pledget suture when the transmyocardial pledget is in a post-cinched configuration.

33. 22. The pericardial fixation system of claim 21, wherein a predetermined resistance between the transmyocardial pledget suture and the plurality of pledget apertures is operable to prevent relative movement of the transmyocardial pledget in a fastened configuration.

34. 32. The pericardial fixation system of claim 31, wherein translating the compression element along the transmyocardial pledget suture and away from the pericardial anchor minimally affects the post-fastening configuration of the transmyocardial pledget.

35. 26. The pericardial fixation system of claim 25, wherein the compression element is a small pledget.

36. 26. The pericardial fixation system of claim 25, wherein the compression element is a compression sleeve.

37. applying tension to the pericardial anchor suture woven through the pericardial anchor to deploy; translating a compression element along a pledget suture woven through the transmyocardial pledget in a pre-clamped configuration to transform the transmyocardial pledget into a post-clamped configuration; and securing the transmyocardial pledget in a post-clamped configuration; 1. A method for deploying a pericardial fixation system, comprising:

38. 38. The method of claim 37, wherein the compression element applies pressure to a surface of the transmyocardial pledget to deform the transmyocardial pledget into a post-fastening configuration.

39. 38. The method of claim 37, wherein the predetermined resistance secures the transmyocardial pledget in a clamped configuration.

40. 38. The method of claim 37, wherein the compression element translates in a direction toward the pericardial anchor to deform the transmyocardial pledget into a post-fastening configuration.

41. 38. The method of claim 37, wherein minimal tension is applied to the pledget suture when the transmyocardial pledget is in the post-cinched configuration.

42. 38. The method of claim 37, further comprising threading the pericardial anchor suture and the pledget suture through a suture lock in an anchor socket connected to the transmyocardial pledget.

43. 38. The method of claim 37, wherein deployment of the pericardial anchor comprises forming a disk.

44. securing the pericardial anchor by applying tension to a pericardial anchor suture integrated with the pericardial anchor; tightening the transmyocardial pledget by translating a compression element along a pledget suture integral 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 in 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; 1. A method for repairing a mitral valve chordae, comprising:

45. 45. The method of claim 44, wherein the compression element translates in a direction toward the pericardial anchor to deform the transmyocardial pledget to a post-fastening configuration.

46. 46. ​​The method of claim 45, wherein minimal tension is applied to the pledget suture when the transmyocardial pledget is in the post-cinched configuration.

47. 46. ​​The method of claim 45, wherein a desired resistance maintains the transmyocardial pledget in the clamped configuration.

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