Suture tension distribution

Abstract

A tension distribution device includes a rotational symmetry structure and two or more suture engagement features associated with the rotational symmetry structure, the suture engagement features configured to receive one or more suture portions therein. The two or more suture engagement features are rotationally evenly spaced about an axial center of the rotational symmetry structure.

Description

[0001] Related applications

[0002] This application claims the benefit of U.S. Application No. 63 / 001,076, filed March 27, 2020, the disclosure of which is hereby incorporated, in its entirety, for all purposes. Technical Field

[0003] This disclosure generally relates to the field of suture tension. Background Technology

[0004] Some medical procedures and others involve the use of sutures or other similar devices. The tension of these sutures (one or more) can affect their behavior over time. Summary of the Invention

[0005] This article describes methods and apparatus for promoting the uniform distribution and / or rebalancing of sutures—such as those used in conjunction with cardiac lobule tissue anchors.

[0006] In some embodiments, this disclosure relates to a tension distribution device comprising a rotationally symmetric structure and two or more suture engagement features associated with the rotationally symmetric structure, the suture engagement features being configured to receive one or more suture portions therein. The two or more suture engagement features are rotatably and uniformly spaced about an axial center of the rotationally symmetric structure.

[0007] The rotationally symmetric structure may be at least partially disk-shaped.

[0008] In some instances, the rotationally symmetric structure includes a top side and a bottom side. For example, the top side of the rotationally symmetric structure may have one or more suture channels associated therewith. In some instances, the two or more suture joining features include an opening extending axially from the top side through the rotationally symmetric structure to the bottom side.

[0009] The two or more suture joining features may include four suture joining features.

[0010] In some instances, the two or more suture joining features are composed of three suture joining features. For example, the rotationally symmetric structure may be at least partially triangular in shape.

[0011] The two or more suture joining features may be associated with the radial side portion of the tension distribution device.

[0012] In some instances, the tension distribution device further includes an axial cover. For example, the cover may have a central opening therein. In some instances, the cover forms a housing having the rotationally symmetric structure, the housing being configured to house the seams therein.

[0013] In some embodiments, this disclosure relates to a method for tensioning sutures. The method includes: engaging one or more first suture portions with a first suture engagement feature of a rotationally symmetric tension distribution device; engaging one or more second suture portions with a second suture engagement feature of the tension distribution device; forming couplings between the one or more first suture portions and the one or more second suture portions on a proximal side of the tension distribution device; and adjusting the tension of the one or more first suture portions and the tension of the one or more second suture portions, at least partially by allowing the couplings to migrate toward the first suture engagement feature.

[0014] Forming the coupling may include binding the one or more first stitch portions together with the one or more second stitch portions to form one or more knots.

[0015] In some instances, the coupling element includes a clamping device.

[0016] The migration of the coupling member toward the first suture joining feature can balance the tension of the one or more first suture portions and the tension of the one or more second suture portions.

[0017] In some instances, adjusting the tension of the one or more first suture portions and the tension of the one or more second suture portions involves reducing the tension of the one or more first suture portions and reducing the tension of the one or more second suture portions.

[0018] In some instances, the tension adjustment of the one or more first suture portions and the tension adjustment of the one or more second suture portions are performed postoperatively within the patient's closed thoracic cavity.

[0019] The method may further include pulling a slack out from at least one of the one or more first suture portions and the one or more second suture portions before forming the coupling.

[0020] In some instances, the first suture joining feature and the second suture joining feature are positioned on the common radial axis of the tension distribution device and on opposite sides of the suture tensioning device.

[0021] In some instances, the one or more first suture portions are associated with a first implanted tissue anchor, and the one or more second suture portions are associated with a second implanted tissue anchor.

[0022] In some embodiments, this disclosure relates to a tension balancing device comprising: a first plate structure; a second plate structure; a support shaft fixed to the second plate structure; a first suture fixing feature associated with one of the first plate structure and the second plate structure; and a second suture fixing feature associated with said one of the first plate structure and the second plate structure.

[0023] The first plate structure may have a recess configured to receive the vertex portion of the support shaft.

[0024] In some instances, the pivot is hemispherical in shape.

[0025] In some instances, the support shaft is tapered.

[0026] Each of the first suture fixing feature and the second suture fixing feature may include a bar and an end flange.

[0027] In some embodiments, this disclosure relates to a method for balancing tension in a suture. The method includes: securing one or more first suture portions to a first suture engagement feature associated with a first rotationally symmetric plate structure of a tension balancing device; securing one or more second suture portions to a second suture engagement feature associated with the first plate structure; and adjusting the tension of the one or more first suture portions to orient the first plate structure more parallel to the second plate structure, wherein a support shaft is disposed between the first plate structure and the second plate structure.

[0028] The method may further include placing the first plate structure on the support shaft, wherein the support shaft is fixed to the second plate structure.

[0029] The method may further include attaching the tension balancing device to the tourniquet.

[0030] The method may further include clamping the one or more first suture portions and the one or more second suture portions after the adjustment.

[0031] In some instances, securing the one or more first seam portions involves wrapping the one or more first seam portions around a rod extending axially around the first plate structure.

[0032] The methods disclosed herein also encompass simulations of said methods, which can be used, for example, for teaching, demonstration, testing, device development, and program development. For example, methods for treating or diagnosing a patient include corresponding simulations performed on a simulated patient. Suitable simulated patients or anthropogenic ghosts can include any combination of physical and virtual elements. Examples of physical elements include whole-human or animal carcasses or any part thereof, including organ systems, individual organs, or tissues; and fabricated carcass, organ systems, organs, or tissue simulations. Examples of virtual elements include visual simulations that can be displayed on a screen; projected onto a screen, surface, or volume; and holographic images. Simulations can also include one or more other types of sensory input, such as auditory, tactile, and olfactory stimuli.

[0033] For the purpose of summarizing this disclosure, certain aspects, advantages, and novel features have been described. It should be understood that not all such advantages can be implemented in any specific instance. Therefore, the disclosed instances may be implemented in a manner that achieves or optimizes one or more advantages taught herein, without necessarily achieving other advantages taught or proposed herein. Attached Figure Description

[0034] Various examples are depicted in the accompanying drawings for illustrative purposes and should in no way be construed as limiting the scope of this disclosure. Furthermore, various features of different disclosed examples may be combined to form other examples as part of this disclosure. Reference numerals may be repeated throughout the drawings to indicate correspondences between reference elements. However, it should be understood that the use of similar reference numerals in multiple drawings does not necessarily imply similarity between their corresponding examples. Moreover, it should be understood that the features in the corresponding drawings are not necessarily drawn to scale, and their illustrative dimensions are shown for illustrative purposes of their inventive aspects. Generally, some of the illustrated features may be relatively smaller than those shown in some examples or configurations.

[0035] Figure 1 It is a cross-sectional view of the human heart.

[0036] Figure 2 It is a perspective view of an organization anchor delivery device based on one or more examples.

[0037] Figure 3 It is a cross-sectional view of a tissue anchor delivery device, at least partially disposed within a cavity of the heart, according to one or more examples.

[0038] Figure 4 This is a close-up view of the distal portion of the shaft assembly of a tissue anchor delivery device for positioning against a target heart valve leaflet, based on one or more instances.

[0039] Figure 5 It is a close-up view of the distal portion of the shaft of a tissue anchor delivery device according to one or more examples, from which the needle and tissue anchor sutureform extend through the target heart valve leaflet.

[0040] Figure 6 This is a close-up view of the distal portion of the tissue anchor delivery device shaft assembly positioned against the target heart valve leaflet according to one or more instances, and the associated tissue anchor deployed on the distal side of the leaflet.

[0041] Figure 7 A cross-sectional view is shown of the leaflet anchors deployed in the heart according to one or more instances.

[0042] Figure 8 A top view shows a heart valve with multiple tissue anchors implanted in a leaflet according to one or more examples.

[0043] Figure 9 Multiple pairs of sutures are shown, based on one or more examples, passing through the heart tissue wall and through the tourniquet.

[0044] Figure 10 The image shows multiple pairs of sutures that pass through the heart tissue wall and are knotted on a pledget, based on one or more examples.

[0045] Figure 11 The image shows a cross-sectional view of a heart based on one or more examples, the heart including multiple leaflet anchors implanted therein.

[0046] Figure 12 The image shows a cross-sectional view of a heart based on one or more examples, the heart including multiple leaflet anchors implanted therein.

[0047] Figure 13 A cross-sectional side view of a tension distribution device coupled with a suture, based on one or more examples, is shown.

[0048] Figure 14 A cross-sectional side view of a tension distribution device coupled with a suture, based on one or more examples, is shown.

[0049] Figure 15 Top and side perspective views of a tension distribution device based on one or more examples are shown.

[0050] Figure 16 The diagram shows bottom and side perspective views of a tension distribution device based on one or more examples.

[0051] Figure 17 The image shows a top or bottom view of a tension distribution device including four suture joining features, based on one or more examples.

[0052] Figure 18 The image shows a top or bottom view of a tension distribution device including three suture joining features, based on one or more examples.

[0053] Figure 19 The image shows a top or bottom view of a tension distribution device including two suture joining features, based on one or more examples.

[0054] Figure 20 The diagram shows bottom and side perspective views of a tension distribution device including a convex protrusion, based on one or more examples.

[0055] Figure 21-1 and Figure 21-2 A side view of an implanted tension distribution device, having a convex protrusion, is shown according to one or more examples.

[0056] Figure 22 A side view of a tension distribution device with lateral suture joining features, based on one or more examples, is shown.

[0057] Figure 23 Top and side perspective views of a tension distribution device with lateral stitching features, based on one or more examples, are shown.

[0058] Figure 24 Displays based on one or more instances Figure 23 The tension distribution device is shown in both bottom and side perspective views.

[0059] Figure 25 A side view of a tension distribution device with covering features, based on one or more examples, is shown.

[0060] Figure 26 Top and side perspective views of a tension distribution device with covering features, based on one or more examples, are shown.

[0061] Figure 27 Displays based on one or more instances Figure 26 Top and side perspective views of the tension distribution device.

[0062] Figure 28 Top and side perspective views of a tension distribution device with one or more proximal suture channels, based on one or more examples, are shown.

[0063] Figure 29 A side view of a tension distribution device having one or more proximal suture channels, according to one or more examples, is shown, wherein one or more suture portions are engaged with one or more proximal suture channels.

[0064] Figure 30 A side view of a tension distribution device arranged on a gasket according to one or more examples is shown.

[0065] Figure 31 The diagram shows bottom and side perspective views of a tension distribution device based on one or more examples.

[0066] Figure 32 A perspective view of the base of a tension distribution device according to one or more examples is shown.

[0067] Figure 33 A perspective view of at least a portion of a tension distribution device according to one or more examples is shown.

[0068] Figure 34 The diagram shows at least a portion of the tension distribution device according to one or more examples, in both bottom and side perspective views.

[0069] Figure 35 A side view of a tension distribution device engaged with multiple suture sections, based on one or more examples, is shown.

[0070] Figure 36 It is a flowchart of the process of distributing or balancing tension among multiple suture sections and / or groupings of suture sections based on examples of one or more instances.

[0071] Figure 37 A side view of a tension balancing device based on one or more examples is shown.

[0072] Figure 38 The base portion of a tension balancing device according to one or more examples is shown.

[0073] Figure 39 A perspective view of the balancer section of a tension balancing device according to one or more examples is shown.

[0074] Figure 40 The components of a tension balancing device comprising four suture fixing features are shown according to one or more examples.

[0075] Figure 41 The components of a tension balancing device comprising three suture fixing features are shown according to one or more examples.

[0076] Figure 42 The components of a tension balancing device comprising two suture fixing features are shown according to one or more examples.

[0077] Figure 43 The components of a tension balancing device, including a slit-type suture fixing feature, are shown according to one or more examples.

[0078] Figures 44-48 Side and perspective views of tension balancing devices subjected to various suture tension conditions, based on one or more examples, are shown respectively.

[0079] Figure 49-1 and Figure 49-2 A flowchart showing the process of tensioning a suture, based on one or more examples, is provided.

[0080] Figure 50-1 and Figure 50-2 Displays AND and AND values ​​based on one or more instances. Figure 49-1 and Figure 49-2 The corresponding boxes, states, and / or operations related to the process are represented by certain images.

[0081] To further illustrate various aspects of the embodiments of this disclosure, a more specific description of certain embodiments will be made with reference to various aspects of the accompanying drawings. It should be understood that these drawings depict only typical embodiments of the disclosure and should therefore not be considered as limiting the scope of the disclosure. Furthermore, while the drawings may be drawn to scale for some examples, they are not necessarily drawn to scale for all examples. Embodiments of this disclosure will be described and illustrated with additional specificity and detail using the accompanying drawings. Detailed Implementation

[0082] The following description refers to the accompanying drawings, which illustrate specific examples. Other examples with different structures and operations do not depart from the scope of this disclosure. Examples of this disclosure relate to apparatus and methods for distributing and / or balancing the tension of sutures or suture portions. For example, some examples of this disclosure relate to the distribution / balancing of suture portions associated with tissue anchors (e.g., suture knots) deployed in conjunction with procedures such as heart valve repair (e.g., mitral valve repair) – which, according to some embodiments, can be performed on a beating heart. Regarding delivery devices and systems for delivering such tissue anchors, such delivery devices / systems may herein be referred to as tissue anchor delivery devices / systems and / or valve repair devices / systems.

[0083] This article discloses a suture tension balancing / distribution device, which may have a button-like shape or form. The device can be used to ensure or promote the uniform distribution of tension across sutures (e.g., suture portions) implanted in biological tissue such as one or more valve leaflets (e.g., mitral or tricuspid valve leaflets). Proper suture tension balancing can advantageously reduce the risk of postoperative suture breakage under tension. In some examples, the suture tension balancing / distribution device can promote further self-balancing of the implanted suture postoperatively, which can be helpful in cases of changes in the patient's cardiac condition or when residual tension differences exist in the suture after implantation.

[0084] In some examples, a suture tension distribution device may include multiple suture engagement features (e.g., inlets) configured to allow opposing sutures to connect / couple to each other. In cases where one suture acquires higher tension over time, the device may be configured to pull on opposing sutures to redistribute the tension load to less tensioned sutures (one or more), potentially extending the effectiveness of the associated procedure.

[0085] The suture joining feature can be embedded in the suture tension distribution device and configured to allow the suture to pass through and be fished. For example, a pair of sutures or other suture groups can be connected / coupled together by the suture joining feature to allow one suture (or suture group) to pull one or more opposing sutures (or suture groups) when tension is acquired. This pulling action allows the acquired tension to be evenly distributed among the coupled sutures.

[0086] The following includes a general description of the anatomy of the human heart, which relates to certain inventive features and examples disclosed herein and is included to provide background for certain aspects of this disclosure. In humans and other vertebrates, the heart typically comprises a muscular organ with four pumping chambers, wherein its flow is controlled at least in part by various cardiac valves, namely the aortic valve, mitral valve (or bicuspid valve), tricuspid valve, and pulmonary valve. These valves can be configured to open and close in response to pressure gradients present during various phases of the cardiac cycle (e.g., diastole and systole) to at least partially control blood flow to corresponding areas of the heart and / or to blood vessels (e.g., those of the lungs, the aorta, etc.).

[0087] Figure 1 An example diagram illustrating a heart 1 having various features relevant to certain aspects of the present invention is provided. The heart 1 comprises four chambers: a left ventricle 3, a left atrium 2, a right ventricle 4, and a right atrium 5. A muscular wall 17, referred to as a diaphragm, separates the left atrium 2 and right atrium 5, as well as the left ventricle 3 and right ventricle 4. The lower apex 19 of the heart 1 is referred to as the apex and is located approximately on the midclavicular line in the fifth intercostal space. The apex 19 can be considered as part of a larger apical region 39.

[0088] The left ventricle 3 is the primary pumping chamber of the heart 1. A healthy left ventricle is generally conical or apical in shape because its length (along the longitudinal axis extending from the aortic valve 7 to the apex 19) is longer than its width (along the transverse axis extending between the opposing walls 25 and 26 at the widest point of the left ventricle) and the cross-sectional circumference gradually decreases to that point, or the apex 19 descends from the base 15. Generally, the apical region 39 of the heart is located within the left or right ventricular region but distal to the mitral valve 6 and tricuspid valve 8, and towards the apex of the heart. More specifically, the apical region 39 can be considered to be approximately 20 cm to the right or left of the central axis 27 of the heart 1.

[0089] Pumping blood from the left ventricle is accomplished through squeezing and twisting or torsional movements. Squeezing occurs between the lateral wall 18 and the diaphragm 17 of the left ventricle. Twisting is a result of myocardial fibers extending around the heart in a circular or spiral direction. When these fibers contract, they create an angular displacement gradient of the myocardium around the longitudinal axis of the heart, from the apex 19 to the base 15. The resultant force vector extends at an angle of approximately 30–60 degrees to the blood flow through the aortic valve 7. When viewed from the apex 19, the contraction of the heart appears as a counterclockwise rotation of the apex 19 relative to the base 15. Due to the spiral contractile force of the heart, a healthy heart can pump blood from the left ventricle in a very efficient manner.

[0090] The heart 1 further includes four valves for assisting blood circulation therein, including a tricuspid valve 8 that separates the right atrium 5 from the right ventricle 4. The tricuspid valve 8 may typically have three cusps or leaflets and is typically closed during ventricular systole (e.g., cardiac contraction) and open during ventricular dilation (e.g., cardiac diastole). The valves of the heart 1 further include a pulmonary valve 9 that separates the right ventricle 4 from the pulmonary artery 11 and may be configured to open during cardiac systole to pump blood toward the lungs and close during cardiac diastole to prevent blood from leaking back into the heart from the pulmonary artery. The pulmonary valve 9 typically has three cusps / lealets, each of which may have a crescent shape. The heart 1 further includes a mitral valve 6 that typically has two cusps / lealets and separates the left atrium 2 from the left ventricle 3. The mitral valve 6 is typically configured to open during cardiac diastole, allowing blood in the left atrium 2 to flow into the left ventricle 3, and advantageously close during cardiac diastole to prevent blood from leaking back into the left atrium 2. Aortic valve 7 separates left ventricle 3 from aorta 12. Aortic valve 7 is configured to open during cardiac systole to allow blood to leave left ventricle 3 and enter aorta 12, and to close during cardiac diastole to prevent blood from leaking back into left ventricle 3.

[0091] Atrioventricular (e.g., mitral and tricuspid) heart valves may include a collection of chordae tendineae (13, 16) and papillary muscles (10, 15) to secure the leaflets of the respective valves, facilitating and / or promoting proper alignment of the leaflets and preventing their prolapse. For example, papillary muscles typically include finger-like projections from the ventricular wall. Regarding the tricuspid valve, a normal tricuspid valve may include three leaflets and three corresponding papillary muscles (10). Figure 1 (Two are shown in the image). The leaflets of the tricuspid valve can be referred to as the anterior leaflet, posterior leaflet, and septal leaflet, respectively. The valve leaflets are connected to the papillary muscle 10 via chordae tendineae 13, which, together with the papillary muscle 10, are located in the right ventricle 4.

[0092] Surrounding the ventricles (3 and 4) are multiple arteries (not shown) that supply oxygenated blood to the heart muscle, and multiple veins that allow blood to return from the heart muscle. The coronary sinus (not shown) is a relatively large vein that typically extends around the upper part of the left ventricle (3) and provides a return pathway for blood to return to the right atrium (5). The coronary sinus terminates at the coronary ostium (not shown), through which blood enters the right atrium.

[0093] Regarding the mitral valve, a normal mitral valve comprises two leaflets (anterior and posterior) and two corresponding papillary muscles 15. The papillary muscles 15 originate from the left ventricular wall and extend into the left ventricle. Normally, the anterior leaflet covers approximately two-thirds of the valve annulus. Although the anterior leaflet covers a larger portion of the valve annulus, in some anatomical structures, the posterior leaflet may include a larger surface area.

[0094] Various disease processes can impair the normal function of one or more heart valves. These processes include degenerative processes (e.g., Barlow's disease, fibroelastosis), inflammatory processes (e.g., rheumatic heart disease), and infectious processes (e.g., endocarditis). Additionally, damage to the ventricles from previous heart attacks (e.g., myocardial infarction secondary to coronary artery disease) or other heart diseases (e.g., cardiomyopathy) can distort the geometry of the valves, leading to dysfunction. However, the vast majority of patients undergoing valve surgery, such as mitral valve surgery, have degenerative disease that causes dysfunction in one or more leaflets of the valve, resulting in prolapse and regurgitation.

[0095] The mitral valve (6) and tricuspid valve (8) can be divided into three parts: the annulus, the leaflets, and the subvalvular apparatus. The subvalvular apparatus can be considered to include the papillary muscles (10, 15) and the chordae tendineae (13, 16), which can elongate and / or rupture. When the valves function normally, the free edges or margins of the leaflets converge and form a firm occlusion when closed; this arc is referred to in the mitral valve as the occlusal line, occlusal plane, or occlusal region. When the ventricles relax, normal mitral and tricuspid valves open, allowing blood from the atria to fill the decompressed ventricles. When the ventricles contract, the chordae tendineae advantageously and properly tighten or position the valve leaflets, causing the increase in intraventricular pressure to close the valves, thus preventing blood leakage into the atria and ensuring that virtually all blood leaving the ventricles is ejected through the aortic valve (7) or pulmonary valve (9) into the body's arteries. Therefore, normal valve function depends on the complex interactions between the annulus, leaflets, and subvalvular apparatus. Any lesion in these components can lead to valvular dysfunction, which in turn causes valvular regurgitation.

[0096] Generally, there are three mechanisms of valvular regurgitation or dysfunction: these include Carpentier type I, II, and III dysfunction. Carpentier type I dysfunction involves annular dilation, causing normally functioning leaflets to separate and fail to form a tight seal (e.g., improper occlusion). Type I mechanism dysfunction includes leaflet perforation, as in endocarditis. Carpentier type II dysfunction involves one or two leaflets prolapsing above the occlusion plane. This is the most common cause of mitral regurgitation and is often caused by stretching or rupture of the chordae tendineae, which are normally attached to the leaflets. Carpentier type III dysfunction involves restricted movement of one or more leaflets, causing the leaflets to be abnormally confined below the level of the annular plane. Rheumatic diseases (IIIa) or ventricular dilatation (IIIb) can cause leaflet restriction.

[0097] Depending on certain heart valve repair procedures and / or other interventions, access may be made to one or more chambers in the heart 1. Access to a chamber in the heart may be made at any suitable entry point. In some embodiments, access to a chamber of the heart, such as a target ventricle (e.g., the left ventricle) associated with a diseased heart valve, is made via the apical region 39. For example, access to the left ventricle 3 (e.g., for mitral valve repair) may be made by creating a relatively small incision at the apical region 39, close to the central axis 27 of the heart (or slightly to its left). Access to the right ventricle 4 (e.g., for tricuspid valve repair) may be made by creating a small incision at the apical region 39, close to the central axis 27 of the heart or slightly to the right of the central axis 27 of the heart. Thus, access to the ventricle may be made directly via the apex, or via an off-apical location in the apical region 39, but slightly away from the apex / apex, such as via the ventricular lateral wall, the area between the apex and the base of the papillary muscles, or even directly at the base of the papillary muscles. In some implementations, the length of the incision made to access the appropriate cardiac ventricle does not exceed about 1 mm to about 5 cm, 2.5 mm to about 2.5 cm, or about 5 mm to about 1 cm. When seeking a percutaneous approach, access to the apical region of the heart may be achieved by direct needle insertion (e.g., through an 18-gauge needle) without incision into the apical region of the heart, through which appropriate repair instruments can be advanced.

[0098] Certain inventive features disclosed herein relate to the tensioning of sutures and / or suture portions associated with certain heart valve repair systems and devices, and / or to systems, processes, and devices for repairing any other type of target organ tissue. The term “associated with” is used herein in its broad and general sense. For example, where a first feature, element, component, device, or member is described as being “associated” with a second feature, element, component, device, or member, such a description should be understood to indicate that the first feature, element, component, device, or member is physically coupled, attached, connected to, integrated into, or otherwise physically associated with the second feature, element, component, device, or member.

[0099] In some embodiments, a tissue anchor delivery device associated with one or more suture tails / portions requiring tension balancing, according to various aspects of this disclosure, can be used to repair the mitral valve in patients with degenerative mitral regurgitation or other conditions. In some embodiments, a transapical, pump-echo-guided repair procedure is performed, wherein at least a portion (e.g., the axial portion / assembly) of the valve repair system is inserted into the left ventricle and manipulated to the surface of the diseased portion of the target mitral valve leaflet, and is used to deploy / implant a tissue anchor in the target leaflet.

[0100] Tissue anchors (e.g., suture-forming elements that create a large knot) can advantageously be integrated or coupled to one or more artificial / synthetic cords that function similarly to chordae tendineae. Such artificial cords (one or more) may include sutures (one or more) and / or suture tails associated with the knot-shaped tissue anchor, and may contain any suitable or desired material, such as expanded polytetrafluoroethylene (ePTFE) or the like. The term "suture" is used herein in its broad and general sense and may refer to any elongated cord, strip, strand, thread, ligature, cord, band, strip, or portion thereof, or other types of materials used in medical procedures (e.g., ePTFE sutures, for example, ...). (Suture, WLGore, Newark, Delaware). Those skilled in the art will understand that wire or other similar materials can be used instead of suture. Furthermore, in some contexts herein, the terms “rope,” “tendon,” “suture section,” and “suture” are used substantially interchangeably. Additionally, any suture-related terms listed above, including the use of the singular forms of the terms “suture” and “rope,” may refer to a single suture / rope or a portion thereof. For example, in cases where a suture knot or anchor is deployed and where two suture sections / tails extend from the knot / anchor, either suture section may be referred to as “suture” or “rope,” regardless of whether these sections are part of a single suture or rope. Furthermore, references herein to a portion of a single suture length may be referred to as a “suture section,” or simply “suture.”

[0101] Procedures for repairing target organ tissue, such as repairing mitral valve leaflets to resolve mitral regurgitation, may include inserting a tissue anchoring delivery device as described in PCT application number PCT / US2012 / 043761 (published as WO2013 / 003228 and referred to herein as “'761 PCT application”) and / or PCT application number PCT / US2016 / 055170 (published as WO2017 / 059426 and referred to herein as “'170 PCT application”) – the entire disclosure of which is incorporated herein by reference – into the body and extending the distal end of the delivery device proximal to the target tissue (e.g., leaflet).

[0102] Applications '761PCT and '170PCT describe in detail methods and apparatus for performing non-invasive procedures to repair heart valves such as the mitral valve. Such procedures include procedures to repair regurgitation that occurs when the leaflets of the mitral valve fail to properly align at peak systolic pressure, resulting in unwanted blood flowing back from the ventricle to the atrium. As described in applications '761PCT and '170PCT, corrective procedures can be performed after assessing the dysfunctional heart valve and identifying the source of dysfunction. Various procedures can be performed according to the methods described therein to achieve heart valve repair, depending on the specific abnormality and the tissues involved.

[0103] Figure 2This is a perspective view of a tissue anchor delivery system 100 according to one or more examples. The tissue anchor delivery system 100 can be used to repair heart valves such as the mitral valve and improve their function. For example, the tissue anchor delivery system 100 can be used to reduce the degree of mitral regurgitation in patients with mitral regurgitation caused by, for example, degenerative mitral valve disease leading to mid-segment leaflet prolapse. To repair such a valve, the tissue anchor delivery system 100 can be used to deliver a tissue anchor, such as a suture knot tissue anchor, and anchor it in the prolapsed leaflet. As described in detail below, such a procedure can be performed on a beating heart.

[0104] Delivery system 100 includes a rigid elongated tube 110 forming at least one internal working lumen. Although described in some instances and / or contexts as including a rigid elongated tube, it should be understood that tubes, shafts, lumens, catheters, etc., disclosed herein can be rigid, at least partially rigid, at least flexible, and / or at least partially flexible. Therefore, any such component described herein, whether or not referred to herein as rigid, should be interpreted as possibly being at least partially flexible. For simplicity, the rigid elongated tube 110 may be referred to as a shaft according to this disclosure. The implementation of a valve repair procedure using delivery system 100 can be performed in conjunction with certain imaging techniques designed to provide visibility of the shaft 110 of delivery system 100 according to an imaging modality such as echo imaging. Typically, when performing a valve repair procedure using tissue anchor delivery system 100, the operating physician can advantageously collaborate with an imaging technician, who can coordinate with the physician to facilitate the successful execution of the valve repair procedure.

[0105] In addition to the delivery shaft 110, the delivery system 100 may include a plunger feature 140, which can be used or actuated to manually deploy preformed knots, such as the large knots detailed below. The tissue anchor delivery system 100 may further include a plunger locking mechanism 145, which can act as a safety lock to lock the valve delivery system until it is ready for use or deployment of a leaflet anchor as described herein. The plunger 140 may have an associated suture release mechanism that can be configured to lock a pair of suture tails 195 associated with the preformed knot anchor (not shown) to be deployed in relative position. For example, the suture portions 195 may be ePTFE sutures. The system 100 may further include a flush port 150 for degassing the lumen of the shaft 110. For example, heparinized saline flushing fluid or the like may be connected to the flush port 150 using a female Luer connector to degas the valve repair system 100. The term "lumen" is used herein in its broad and general sense and can refer to a physical structure that forms a cavity, void, passage, or other channel, such as an elongated tubular structure that is at least partially rigid, or it can refer to the cavity, void, passage, or other channel itself that occupies space within an elongated structure (e.g., a tubular structure). Therefore, with respect to elongated tubular structures such as shafts, tubes, or the like, the term "lumen" can refer to the elongated tubular structure and / or to a channel or space within an elongated tubular structure.

[0106] The lumen of shaft 110 can accommodate a needle (not shown) that is at least partially wound around a pre-formed knot suture anchor, as described in detail herein. In some examples, shaft 110 has a relatively low profile. For example, shaft 110 may have a diameter of approximately 3 mm or less (e.g., 9 Fr). Shaft 110 is associated with an atraumatic tip 114. The atraumatic tip 114 may be an echo lobule locator component, which can be used to deploy and / or locate suture-type tissue anchors. As described herein, the atraumatic tip 114, located at the distal end of shaft 110, can be configured to deploy and wind from a pre-formed knot (e.g., a suture anchor).

[0107] The atraumatic distal end 114 may be referred to as an "end effector". In addition to the preformed knot suture forming element and associated needle, shaft 110 may also accommodate an elongated knot pusher tube (not shown; also referred to herein as a "pusher"), which in some examples may be actuated using plunger 140. As described in further detail below, distal end 114 provides a surface against which the target valve leaflet associated with the deployment of the leaflet anchor can be held.

[0108] As described in more detail below, delivery device 100 can be used to deliver a “large knot” type tissue anchor. For example, delivery device 100 can be used to deliver a tissue anchor (e.g., a large knot) distal to the mitral valve leaflet. A distal end 114 (e.g., an end effector) can be positioned to contact the ventricular side of the mitral valve leaflet. The distal end 114 can be coupled to the distal portion of shaft 110, wherein the proximal portion of shaft 110 can be coupled to the handle portion 120 of delivery device 100, as shown. Typically, an elongated pusher (not shown) can be movably disposed within the lumen of shaft 110 and coupled to a pusher hub (not shown), which is movably disposed within handle 120 and releasably coupled to plunger 140. A needle (not shown) carrying a pre-formed tissue anchor suture form can be movably disposed within the lumen of the pusher and coupled to a needle hub (not shown) also coupled to plunger 140. The plunger 140 can be used to actuate or move the needle and pusher during deployment of the distal anchor (see example). Figure 8 and Figure 9 And is at least partially movably disposed within the handle 120. For example, the handle 120 may define a lumen in which the plunger 140 may move. During operation, the plunger may also move within the lumen of the handle 120. The plunger lock 145 may be used to prevent the plunger 140 from moving within the handle 120 during storage and before performing the procedure for deploying the tissue anchor.

[0109] The needle may have a pre-formed knot disposed around its distal portion while being held in the shaft 110. For example, the pre-formed knot may be formed from one or more threads configured as a coiled thread-formed element (see...). Figure 7 The suture forming element has multiple windings / turns around the needle on the portion of the needle associated with a longitudinal slot extending from its distal end. Although the term "suture forming element" is used herein, it should be understood that such a component / forming element may include suture, thread, or any other elongated material wrapped or shaped in a desired configuration. The coiled suture forming element may be provided or transported for placement around the needle. In some examples, two suture tails extend from the coiled suture forming element. Suture tails 195 may extend through the lumen of the needle and / or through a channel of plunger 140 and may exit plunger 140 at their proximal portions. As described in more detail below, the coiled suture forming element may be advantageously configured to form a suture-type tissue anchor (referred to herein as a "large knot") in relation to an anchor deployment procedure. The coiled suture forming element may be configured in a structural / deployment configuration by bringing the opposite ends of its coiled portions close together to form one or more loops.

[0110] The delivery device may further include a suture / tether capture mechanism (not shown) coupled to the plunger 140 at the proximal end of the delivery device 100, which may be configured to releasably retain or secure the suture 195 extending through the delivery device 100 during delivery of the tissue anchor as described herein. A suture catch may be used to retain the suture 195 by frictional engagement or clamping force, and may have a lock that can be released after the tissue anchor has been deployed / formed into a large knot, as described herein.

[0111] As described herein, the anchor delivery device 100 can be used in beating heart mitral valve repair procedures. In some examples, the shaft 110 of the delivery device 100 can be configured to extend and contract with each heartbeat. During systole, the central axis of the heart typically shortens. For example, in some patients, the distance from the apex 19 of the heart to the valve leaflets 52, 54 can vary from about 1 cm to about 2 cm with each heartbeat. In some examples, the length of the shaft 110, projecting from the handle 120, can vary with the length of the central axis of the heart. That is, the distal end of the shaft 110 can be configured to float, allowing the shaft to extend and contract with each heartbeat to maintain contact with the target mitral valve leaflet.

[0112] Advancement of the delivery device 100 can be performed in conjunction with echo imaging, direct visualization (e.g., direct blood visualization), and / or any other suitable remote visualization technique / modality. For example, for cardiac procedures, the delivery device 100 can be advanced in conjunction with transesophageal (TEE) guidance and / or intracardiac echocardiography (ICE) guidance to facilitate and guide the movement and proper positioning of the device to contact the appropriate target cardiac region and / or target cardiac tissue (e.g., valve leaflet, valve annulus, or any other suitable cardiac tissue). Typical procedures that can be performed using echo guidance are described in Suematsu, Y., J. Thorac. Cardiovasc. Surg. 2005; 130:1348–56 (“Suematsu”), the entire disclosure of which is incorporated herein by reference.

[0113] Figure 3This is a cross-sectional view of a tissue anchoring delivery device 100, at least partially disposed within a cardiac chamber according to one or more embodiments. According to some embodiments of valve repair procedures, an incision is formed in the apical region 39 of the appropriate ventricle 33 of the heart. For example, an inlet port device 200, including one or more fluid retention valves to prevent blood loss and / or air from entering the ventricle 33, can be inserted into the entry site. Once within the chamber 33, the shaft 110 of the delivery device 100 can be advanced through the lumen 220 of the inlet 200. In some examples, a sheath can be inserted through the inlet 200, and one or more other instruments can be advanced through the inlet 200. For example, an endoscope can be first advanced into the chamber 33 to visualize the ventricle, valve 36, and / or subvalvular device. Using a suitable endoscope, the dysfunctional valve 36 can be carefully analyzed. Each segment of each leaflet can be carefully evaluated to determine its flexibility, integrity, and movement. Based on this evaluation, the physician can determine whether the valve can indeed be repaired or must be replaced. The movement of leaflets 52 and 54 can be classified as mild dysfunction, prolapse, or restriction, and based on this classification, the necessary steps for repair can be determined.

[0114] Mitral regurgitation typically increases the workload on the heart and, if left untreated, can lead to very serious conditions such as decreased ventricular function, pulmonary hypertension, congestive heart failure, permanent heart damage, cardiac arrest, and ultimately death. Since the left side of the heart is primarily responsible for circulating blood throughout the body, mitral valve dysfunction is particularly problematic and often life-threatening. This document, along with applications '761 PCT and '170 PCT, provides methods and apparatus for performing non-invasive procedures to repair heart valves such as the mitral valve. Such procedures include repairing regurgitation that occurs when the leaflets of the mitral valve fail to properly align at peak systolic pressure, resulting in unwanted blood flow from the ventricles back into the atria. As described in applications '761 PCT and '170 PCT, corrective procedures can be performed after assessing the dysfunctional heart valve and identifying the source of the dysfunction. Various procedures can be performed according to the methods described therein to achieve heart valve repair, depending on the specific abnormality and the tissues involved.

[0115] After determining that a minimally invasive approach is preferable, one or more incisions may be made near the thoracic cavity to provide access to the surgical area. The total number and length of the incisions to be made depend on the number and type of instruments to be used and the procedure (one or more) to be performed. The incisions (one or more) can be advantageously made in a minimally invasive manner. As referred to herein, the term “minimally invasive” means a manner that allows access to internal organs or tissues with relatively little damage to the anatomical structures being sought. For example, a minimally invasive procedure may involve access to a body cavity through a small incision, such as approximately 5 cm or less, made in the skin of the body. The incision may be vertical, horizontal, or slightly curved. If the incision is located along one or more ribs, it can advantageously follow the contours of the ribs. The opening can advantageously extend deep enough to allow access to the thoracic cavity between the ribs or below the sternum, and is preferably positioned close to the costal margin and / or diaphragm, depending on the chosen point of entry.

[0116] In one example approach, access to the heart can be achieved through one or more openings formed by one or more small incisions in a body part near the thoracic cavity, such as between one or more ribs of the patient's ribcage, near the xiphoid process, or via the abdomen and diaphragm. Access to the thoracic cavity may be sought to allow insertion and use of one or more thoracoscopic instruments, while access to the abdomen may be sought to allow insertion and use of one or more laparoscopic instruments. Access to the heart can then be achieved via the diaphragm after insertion of one or more visualization instruments. Alternatively, access to the heart can be achieved by direct puncture from the xiphoid region (e.g., via a needle of appropriate size, such as an 18-gauge needle). Therefore, one or more incisions should be formed in such a way that they provide a suitable surgical area and site of access to the heart in a manner with the least possible invasiveness. Percutaneous approaches can also be used to achieve access, further reducing the invasiveness of the procedure. See, for example, “Full-Spectrum Cardiac Surgery Through a Minimal Incision Mini-Sternotomy (Lower Half) Technique,” ​​Doty et al., Annals of Thoracic Surgery 1998; 65(2):573–7 and “Transxiphoid Approach Without Median Sternotomy for the Repair of Atrial Septal Defects,” Barbero-Marcial et al., Annals of Thoracic Surgery 1998; 65(3):771–4,” the full contents of each of the above references are incorporated herein by reference.

[0117] Typically, the shaft 110 of the tissue anchor delivery device 100 can be slowly advanced into the introducer 200 until the distal end 114 is flush with the introducer 200 and enters the ventricle 33. In doing so, it is desirable to advance the shaft 110 within the ventricle 33 in such a manner that it avoids crossing areas occupied by papillary muscles and / or associated chordae tendineae to avoid entanglement with them. To facilitate or ensure avoidance of such anatomical structures, imaging techniques can be advantageously implemented to provide visibility of the shaft 110 within the ventricle 33, as well as at least partial visibility of certain anatomical features within the ventricle. In some embodiments, hybrid imaging techniques can be used, where echo imaging is combined with different imaging modalities. Multiple imaging modalities can provide improved visibility of anatomical and / or delivery system components.

[0118] Although the procedures described herein are referenced to the repair of the mitral or tricuspid valve of the heart via the implantation of one or more leaflet anchors and associated sutures (one or more) / cords (one or more), the presented methods are readily applicable to various types of tissue, leaflet, and valve annulus repair procedures. For example, the methods described herein can be performed to selectively bring two or more portions of tissue closer together to limit the gap between these portions. That is, in general, the methods described herein are referenced to the mitral valve but should not be construed as limited to procedures involving the mitral valve. Furthermore, aspects of this disclosure can be applied to non-biological structures and devices. For example, other cord or suture tensioning applications that do not involve biological tissue can be incorporated into aspects of the tension balancing and / or distribution devices, systems, and processes disclosed herein.

[0119] Figure 4 A close-up view of the shaft 110 of a tissue anchor delivery device 100 associated with a valve repair procedure, according to one or more embodiments of this disclosure, is shown. The shaft 110 is inserted into the ventricle 33 (e.g., the left ventricle) and approaches the target valve leaflet 54. For example, the valve 36 may be the mitral valve. The anchor delivery device shaft 110 can be configured to deliver a tissue anchor (not shown; see example...) Figures 5-7 Large knots, for example, are delivered to the valve leaflet 54. As an example, Figure 4 The valvular leaflet 54 is shown, which may represent the posterolateral leaflet of the mitral valve. It should be understood that the anchor delivery device shaft 110 can also deliver a tissue anchor to the anteromedial mitral valve leaflet. Although the following... Figures 4-7 The description is presented in the context of the mitral valve, but it should be understood that the principles disclosed herein apply to other valves or biological tissues, such as the tricuspid valve.

[0120] refer to Figures 4 to 7The anchor delivery device shaft 110 may include one or more elongated lumens configured to allow delivery of the anchor 190 to the valve leaflet 54. The shaft 110 may be configured to facilitate the execution of one or more functions such as grasping, aspiration, flushing, cutting, suturing, or otherwise engaging the valve leaflet. The distal end or tip 114 of the shaft 110 may be configured to contact the mitral valve leaflet 54 substantially without damaging the leaflet to facilitate valve 36 repair. For example, during a valve repair procedure, a handle (e.g., handle 120) coupled to the shaft 110 can be manipulated in such a way that the leaflet 54 contacts the functional distal portion of the shaft 110 and achieves repair.

[0121] Echo imaging guidance, such as transesophageal echocardiography (TEE) (2D and / or 3D), transthoracic echocardiography (TTE), and / or intracardiac echocardiography (ICE), can be used to assist in the advancement and desired positioning of the anchor delivery device shaft 110 within the ventricle 33. The distal end 114 of the shaft 110 can contact the proximal surface of the mitral valve leaflet 54 (e.g., relative to...). Figures 4-7 The lower surface of the valve leaflet 54 may be arranged in a manner that does not damage or substantially does not damage the leaflet 54. For example, the end / terminal portion or component 114 may have a relatively blunt form or configuration. The end / terminal portion or component 114 may be configured to maintain proximal contact with the valve leaflet 54 during cardiac pulsation to facilitate reliable delivery of the anchor 191 / 190 to the target site on the leaflet 54.

[0122] In some examples, one or more piercing devices 130 (e.g., one or more needles) can be delivered through the working lumen of shaft 110 (not shown) to pierce the valve leaflet 54 and allow the suture forming element 191—comprising a suture comprising multiple windings of suture around the distal portion of the needle 130—to extend into the atrium 32 (see [link to relevant documentation]). Figure 5 ), in which the stitching components are deployed to form Figure 6 and Figure 7 The large, knotted anchor element 190 is shown. For example, as... Figure 5As shown, a slotted needle 130 can be deployed from the distal end of shaft 110 to pierce leaflet 54 and extend into atrium 32, wherein the slotted needle 130 is wound with suture forming element 191 (e.g., PTFE suture) in a specific configuration (see '761 PCT application for further details on example suture winding configurations and needles for suture anchor deployment devices and methods). In some examples, a pusher or hollow guide wire (not shown) is provided on or at least partially around the needle 130 within shaft 110, such that the needle can be withdrawn, leaving the pusher and the wound suture forming element 191. When a withdrawal force is applied to the suture forming element 191 using the pusher, the suture forming element 191 can form a large knot-shaped anchor (e.g., anchor 190), after which the pusher can be withdrawn, leaving a permanent knot 190 anchoring suture (one or more) 195 to leaflet 54.

[0123] Figure 4 The shaft 110 of a tissue anchoring delivery device 100 positioned on a target valve leaflet 54 (e.g., a mitral valve leaflet) is shown. The target site of valve 54 can be slowly approached from its ventricular side, for example, by advancing the distal end of shaft 110 along or near the posterior wall of ventricle 33 (e.g., the left ventricle) without contacting the ventricular wall. Successful aiming and contact with the target location on leaflet 54 may depend at least in part on accurate visualization of shaft 110 and / or distal / terminal actuator 114 throughout the advancement of the distal end 114 to the target site. Typically, echocardiographic equipment can be used to provide necessary or desired intraoperative visualization of shaft 110 and / or distal end 114.

[0124] Once the tip 114 is positioned as desired, the distal end of the shaft 110 and the tip 114 can be used to drape the leaflet 54 or "tent" it to better secure the tip 114 in the desired position, such as... Figure 4 As shown. During one or more cardiac cycles, draping / tenting can advantageously facilitate contact between the distal end 114 and the leaflet 54, thereby providing a more secure or appropriate deployment of the leaflet anchor (one or more). The target location can be advantageously positioned relatively close to the free edge of the target leaflet 54 to minimize the possibility of undesirable atrial wall deployment of the anchor. Echo imaging can be used to assist navigation of the distal end 114 to the desired location on the inferior side of the target valvular leaflet 54, and the correct positioning of the distal end 114 can be confirmed by echo imaging prior to anchor / knot deployment.

[0125] As the shaft 110 is positioned against the target leaflet 54, the plunger 140 of the tissue anchor delivery device 100 can be actuated to move the needle 130 and the pusher disposed within the shaft 110, causing the coiled suture forming portion 191 of the suture anchor to slide away from the needle 130. When the plunger 140 is actuated, the distal piercing portion of the needle 130 pierces the leaflet 54 and forms an opening in the leaflet. Figure 5 A close-up view of the distal portion of the delivery device shaft 110 according to one or more examples is shown, revealing a needle 130 extending from it through the target leaflet 54 and a tissue anchoring suture forming element 191. In some examples, the needle 130 extends distally beyond the distal end of the shaft 130 (e.g., beyond the tip 114) by a distance of about 5-8 mm or less. In some examples, the needle 130 extends by a distance of about 3-11 mm. In some examples, the needle 130 extends by a distance of about 2.5 cm or more. In some examples, the needle 130 extends to its distal tip and the entire coiled suture forming element 191 extends through the leaflet 54. When the needle 130 and the suture forming element 191 extend into the atrial side 32 of the leaflet 54, the shaft 110 and the tip 114 are advantageously retained entirely on the ventricular side 33 of the leaflet 54.

[0126] As the pusher (not shown) within the tissue anchor delivery device shaft 110 moves distally, the distal end of the pusher advantageously moves or pushes the distally coiled suture forming element 191 (e.g., the pre-deployed coiled portion of the suture anchor) beyond the distal end of the needle 130 and further within the atrium 32 of the heart distal to the leaflet 54, such that the suture forming element extends distally beyond the distal end of the needle 130. For example, in some examples, at least half the length of the suture forming element 191 extends beyond the distal end of the needle 130. In some examples, at least three-quarters of the length of the suture forming element 191 extends beyond the distal end of the needle 130. In some examples, the entire coiled suture forming element 191 extends beyond the distal end of the needle 130.

[0127] After the suture forming element 191 has been pushed away from the needle 130, pulling proximally on the suture tail (one or more) 195 (e.g., a strand of suture extending from the coiled portion of the suture) associated with the tissue anchor 190 can cause the suture forming element 191 to form a large knot anchor 190, such as Figure 6 As shown, Figure 6 A close-up view is provided of the suture anchor 190 formed on the atrial side 32 of the leaflet 54. For example, the large knotted suture anchor 190 can be made by making the suture forming member 191 (see Figure 6 The opposite ends of the coils are brought close together to form one or more loops. After the suture forming element 191 has formed a large knot 190, the delivery device 100 can be withdrawn proximally, leaving the tissue anchor 190 positioned on the distal atrial side of the lobule 54, as... Figure 7 As shown. In some examples, two suture tails 195 may extend from the proximal / ventricular side 33 of the leaflet 54 and protrude from the heart 10. For example, the delivery device shaft 110 may slide / retract on the suture tails(one or more) 195. The suture tails may be advantageously tensioned in a balanced manner according to various aspects of this disclosure.

[0128] Figure 7 A cross-sectional view of a leaflet anchor 190 deployed according to one or more embodiments of the present disclosure is shown. The suture tail 195 coupled to the anchor 190 may be secured at a desired tension using a pad 71 or other suture securing / locking device or mechanism that extends across the lateral aspect of the heart. For example, in addition to, or in place of, the pad 71 used to secure and / or tension the suture tail 195, suture tension distribution and / or balancing devices according to embodiments of the present disclosure may be utilized. Furthermore, one or more knots (e.g., knot stacks) or other suture securing mechanisms (one or more) or devices (one or more) may be implemented to hold the suture at a desired tension and retain it to the pad / device 71. When the suture tail(one or more) 195 is fixed to the ventricular wall 11, the ventricular portion of the suture tail(one or more) 195 can advantageously serve as an alternative leaflet cord (e.g., chordae tendineae) configured to tether the target leaflet 54 in a desired manner and under desired tension.

[0129] Figure 8 A top view is shown of a heart valve 860 implanted in leaflets 803, 804 according to one or more examples of multiple tissue anchors 892, 893. For example, the heart valve 860 may be a mitral valve, tricuspid valve, or other types of valves or tissues. That is, although some descriptions of the mitral valve are presented below, it should be understood that such descriptions are for simplicity and clarity only, and the principles disclosed herein apply to other types of tissues or anatomical structures.

[0130] Regarding the mitral valve repair procedure, the heart valve 860 can be considered to include an anterior leaflet 804 and a posterior leaflet 803. Leaflets 803 and 804 can be connected at the anterior commissure region 895 and the posterior commissure region 897, respectively. In some embodiments, one or more tissue anchors 892 and 893 can be deployed in one or both of the leaflets 803 and 804. For example, one or more tissue anchors 892 can be implanted in the A1, A2, and / or A3 regions of the anterior leaflet 804 (not shown for clarity). Figure 8 One or more of the following are marked (usually numbered from side to center). Alternatively or additionally, one or more tissue anchors 893 may be implanted in the P1, P2, and / or P3 regions of the posterior lobule 803 (not shown for clarity). Figure 8One or more of the leaflet anchors (usually numbered from the side to the center) are marked in the middle. The deployed leaflet anchors may be positioned approximately below the occlusal surface. Regarding posterior mitral leaflet repair, the anterior leaflet may advantageously contact the posterior leaflet, which serves as the base of the leaflet anchor (one or more).

[0131] Figure 8 Each of the various tissue anchors shown can be associated with one or more suture tails, which may be referred to as suture portions in certain contexts herein. For example, in some embodiments, tissue anchors 892, 893 include suture forming elements in the form of knots, etc. For example, a single monolithic suture can be used to form the illustrated tissue anchor knots, wherein the tail portion associated with the suture / knot extends from the knot to another anchor point, such as... Figure 7 The anchor points are shown located on the lateral ventricular wall or surface. Although some examples are described herein in conjunction with paired suture tails associated with corresponding tissue anchors, in some examples, a single suture tail / part may be associated with a single tissue anchor. Furthermore, it should be understood that regardless of whether such description refers to a single suture portion, a pair of suture portions, or any other number of suture portions / tails, the suture tensioning devices and methods disclosed herein are applicable to the tension balance and / or distribution of any number of suture portions—including single suture tails and paired suture tails associated with a single tissue anchor.

[0132] Thread tension

[0133] Examples of this disclosure provide solutions for achieving matched / balanced tension levels and / or desired tension levels across multiple suture tails and / or pairs of suture tails. Figure 9 Multiple pairs of sutures 995 passing through the heart tissue wall 911 and through the tourniquet 930, according to one or more examples, are shown. In some embodiments, one or more leaflet anchors are deployed in each of the mitral valve leaflets, wherein they are secured together in the heart by tying together sutures / cords coupled to the individual leaflets with knots or by another suitable attachment device, thereby creating an edge-to-edge repair to reduce the septal-lateral distance of the mitral valve orifice.

[0134] According to some procedures, after the associated tissue anchor is placed in the corresponding target tissue, tensioning of the suture portion 995 is performed. With the suture 995 pulled through / through the ventricular wall 911, the end of the suture can be manually pulled to eliminate any slack in the suture 995. Typically, tensioning of the suture 95 may not be performed until such slack is eliminated. After some or all of the slack has been removed from individual sutures and / or suture pairs, the suture 995 can be pulled simultaneously to further increase (or release) the tension thereon. The suture 995 can be pulled together through the tourniquet 930. For example, the suture 995 can be pulled from its proximal portion to achieve the determined / desired tension.

[0135] In some embodiments, a gasket 960 or other type of device may be used to perform suture tensioning and / or securing, the suture portion 995 may pass through the gasket 960 or other type of device and / or the suture portion may be secured to the gasket 960 or other type of device, such as by tying one or more knots or the like (see [link to documentation]). Figure 10 For example, such as Figure 9 As shown, each of the suture pairs 995a, 995b, 995c, which can be associated with a separate tissue anchor (e.g., a heart valve leaflet tissue anchor), can pass through a tissue wall 911, which can be, for example, the ventricular wall associated with the patient's ventricle 33 or other regions / chambers. The suture portion 995 can further pass through a padding device 960, which can at least partially provide cushioning between the proximal suture portion / knot and the tissue wall 911.

[0136] Before placing the pad 960, a knot may be tied to the long free end of the suture 995 outside the heart. The suture portions 995 can be identified as several pairs (995a, 995b, 995c) by their respective associated knots. In some embodiments, the paired sutures may be separated into two strands and passed through the pad 960. A French-eye needle can be used to pull the suture through the pad 960. The pad 960 can be identified proximally based on the location where the paired sutures leave the pad 960. A tourniquet 930 may be abutted against the ventricular wall 911 interface, with the pad 960 positioned between the tourniquet 930 and the tissue wall 911.

[0137] The spacer 960 can be, for example, a spacer with low porosity and relatively rigidity. Such a spacer can advantageously allow the desired tension of the suture tail 995 to be maintained over a prolonged postoperative period. In some examples, one or more soft tissue retractors and / or right-angle clamps (not shown) may be used to perform suture binding or fixation; these soft tissue retractors and / or right-angle clamps may be rubber-tipped to reduce the risk of damage to the suture portion 995.

[0138] In some implementations, the position and / or tension of the tissue anchor and / or associated suture tails (one or more) can be tested by gently tensioning the suture tails until leaflet movement is felt and / or observed. Echo imaging can be used to view and verify the placement of the anchors and the resulting leaflet function. The steps and procedures outlined above for placing suture knot tissue anchors can be repeated as needed until the desired number of anchors are implanted onto the target valve leaflet.

[0139] In some embodiments, tension adjustment can be performed simultaneously in pairs of suture tails 995 associated with multiple tissue (e.g., leaflet) anchors. An appropriate number of leaflet anchors can be advantageously determined to produce the desired occlusion of the target valve leaflet. A pull pad 960 can be pulled against the surface of the tissue wall 911 (e.g., the epicardial surface), and all suture tails 995 can be inserted through a common tourniquet 930 or similar structure, such that all suture portions / tails can be tensioned together.

[0140] Figure 10 Multiple pairs 109 of sutures passing through the cardiac tissue wall 111 and knotted on a pad 106, according to one or more examples, are shown. As shown, in some embodiments, the suture tails may be knotted together proximally to the tissue wall 111. For example, two suture tails exiting from a common tissue anchor may be knotted together against the pad 106. Knotting suture portions together according to aspects of this disclosure may involve forming a knot stack 107, wherein multiple knots are successively tied using a pair of suture tails or pairs of suture tails to provide improved fixation and / or reduce the likelihood of postoperative unraveling.

[0141] In some embodiments, this disclosure relates to apparatus and methods for balancing load distribution on sutures. According to some solutions, the suture may be hand-held, where movement of the mitral valve leaflets allows for pulling on the suture to balance the load. However, such tensioning solutions may not adequately account for changes in postoperative tension over time. For example, after a suturing procedure, the patient's cardiac and leaflet condition may at least partially change, causing previously evenly loaded sutures to become unevenly loaded. This can lead to tension overload on one of the sutures or suture pairs. In some embodiments, this disclosure provides a solution for automatically distributing and / or balancing suture tension load postoperatively through the pulsating movement of the leaflets (one or more), thereby achieving relatively long-term effectiveness relative to the suturing procedure.

[0142] Figure 11 A cross-sectional view of a heart according to one or more embodiments of the present disclosure is shown, the heart including a plurality of lobular anchors 112, 113 implanted therein in respective lobules or lobular portions. Figure 11 As shown in the images, suture tails from a single tissue anchor (e.g., a knot) can be secured to a tissue wall 11 and / or a pad 116 disposed thereon or near it, wherein one of the suture tails (e.g., 118b, 119a) is tighter and / or has greater tension thereon than another suture tail (e.g., 118a, 119b) associated with a particular tissue anchor. For example, tissue anchor 112 is shown deployed against a first valve leaflet or leaflet portion 52, wherein a first suture tail 118a exiting therefrom is looser and / or has more slack than another suture tail 118b associated with tissue anchor 112, while tissue anchor 113 is associated with multiple suture tails 119a, 119b, wherein suture tail 119a is tighter than suture tail 118b.

[0143] Tension differences between suture tails associated with a single tissue anchor can be caused by various factors. For example, the anatomical structure in which a specific tissue anchor and / or associated suture tail is implanted can result in different distances between the distal and proximal tissue fixation points for different suture tails. Furthermore, suture tensioning performed by a qualified technician, whether due to operator error or other contributing factors, can cause one suture tail to be tensioned to a greater extent than the other. In cases such as… Figure 11When the suture tail is unevenly tensioned, uneven stress can be applied to a biological tissue and / or suture / anchor portion, leading to uneven wear, damage, dysfunction, etc. For example, when a disproportionate amount of tension is applied to a suture tail deployed through a specific area or portion of biological tissue, such tissue may be damaged and / or the associated suture may be disproportionately pulled through and / or damaged by such tissue, potentially resulting in physiological impairment and / or other performance failures of the implanted device. Therefore, it is desirable to promote and / or ensure that the tension level associated with separate suture tails of individual tissue anchor devices is balanced to a certain degree and / or tensioned such that the tension difference between such suture portions is reduced or minimized.

[0144] Figure 12 A cross-sectional view of a heart according to one or more embodiments of the present disclosure is shown, the heart including a plurality of lobule anchors 122, 123 implanted therein in respective lobules or lobule portions / tissue portions 52, 54. Figure 12 As shown in the images, suture tails / parts from individual tissue anchors (e.g., knots) can be secured to the tissue wall 11 and / or a pad 126 disposed thereon or near it, wherein the suture portion 128 associated with the first tissue anchor 122 is tighter and / or has greater tension thereon than the suture portion 129 associated with the second tissue anchor 123. For example, the first tissue anchor 122 is shown deployed against the first valve leaflet or leaflet portion 52 and associated with the relatively tight suture portion / tail 128, while the second tissue anchor 123 is shown deployed against the second valve leaflet or leaflet portion 54 and associated with the relatively loose suture portion / tail 129.

[0145] Tension differences between suture tails associated with different tissue anchors can be caused by various factors. For example, the anatomical structure in which a particular tissue anchor and / or associated suture tail is implanted can result in different distances between distal and proximal tissue fixation points for different tissue anchors. Furthermore, whether due to operator error or other contributing factors, suture tensioning performed by a qualified technician can result in the suture tail / part (e.g., suture pair) associated with one tissue anchor being tensioned to a greater extent than the suture tail / part associated with another tissue anchor. In cases such as… Figure 12When the sutures are unevenly tensioned, uneven stress can be applied to a biological tissue and / or the suture / anchor portion, leading to uneven wear, damage, dysfunction, etc. For example, disproportionate tension applied to a leaflet portion can cause valvular regurgitation or other functional defects. Furthermore, the tissue anchored by such an anchor / suture (one or more) may be damaged and / or the associated sutures (one or more) may be disproportionately pulled through such tissue and / or damaged, potentially leading to physiological impairment and / or other performance failures of the implanted device. Therefore, it is desirable to promote and / or ensure that the tension levels associated with the suture tails / portions of different tissue anchoring devices are balanced to a certain degree and / or tensioned such that the tension difference between such suture portions is reduced or minimized.

[0146] Tension distribution device

[0147] In some embodiments, this disclosure relates to a suture tension balancing / distribution device configured to facilitate the balancing / distribution of tension across multiple sutures or suture portions associated with one or more tissue anchors implanted, for example, on the mitral valve leaflets, to help achieve proper merging and reduce regurgitation. This tension redistribution helps prevent any single suture or group of sutures from bearing the majority of the tension load, which could lead to over-tensioning of the sutures (one or more) and / or premature suture breakage, thereby triggering a secondary procedure in some cases.

[0148] Figure 13 A cross-sectional side view of a tension distribution device 136 engaged with sutures 138, 139 according to one or more embodiments of the present disclosure is shown. Figure 13 Multiple suture pairs 138, 139 are shown, as illustrated, each suture pair comprising one or more suture portions. For example, as described in detail herein, such suture portions may be associated with corresponding tissue anchors such as heart valve leaflet anchors. In some embodiments, suture tails 138, 139 may traverse tissue wall 131 and may be anchored on the proximal side 55 of tissue wall 131, thereby securing the respective suture pair and / or suture portion in a tension configuration between a tension distribution device 136 at the proximal end and a distal target tissue fixation position (not shown) at the distal end.

[0149] In some examples, the tension distribution device 136 includes certain suture engagement features configured to allow suture portions and / or pairs of suture portions to engage in a manner that allows the suture portions(one or more) to slide longitudinally through the suture engagement feature. In some examples, the suture engagement feature 135 includes an orifice through which the suture portions and / or pairs of suture portions can be threaded in a certain manner. However, it should be understood that the suture engagement features described and / or implemented in conjunction with any of the tension distribution device examples and / or related processes disclosed herein may include one or more orifices, holes, hooks, slits, channels, paths, eyelets, wedges, or other features(one or more) configured to allow one or more suture portions to engage therewith, thereby at least partially securing or containing the suture portion and / or in a certain manner restricting its lateral, radial, and / or circumferential movement relative to one or more portions of the tension distribution device or limiting its lateral, radial, and / or circumferential movement relative to one or more portions of the tension distribution device to a certain extent.

[0150] In the implantation / deployment configuration, suture portions 138, 139 can engage with corresponding suture engagement features 135 in any suitable or desired manner. For example, in some embodiments, suture engagement features 135 can be circumferentially distributed about their center point relative to any suitable or desired radius of the tension distribution device. For example, a tension distribution device according to an example of this disclosure can have a generally circular, rectangular, triangular, pentagonal, hexagonal, or other axial cross-sectional shape about its central axis 501. The suture engagement features of such a device can advantageously be uniformly and / or relatively distributed around axis 501, such that the application of equal weight at such suture engagement features results in a balanced arrangement of the device. That is, the suture engagement features can advantageously be positioned in a balanced configuration / arrangement about the axial center point of the device. For example, each of the suture engagement features can be positioned or arranged at the same radius from the center point (not shown; see Figure 15 Furthermore, the suture joining features can advantageously be offset by the same amount / angle relative to each other about the axial center point.

[0151] To balance the stitching feature 135 of the central axis 501, examples of tension distribution devices according to various aspects of this disclosure can advantageously possess rotational / radial symmetry about their central axis. That is, one or more rotating cutting planes around the central axis produce similar or identical pieces; such similar / identical pieces are regularly arranged around the central axis. The rotational symmetry of the tension distribution and tension balancing devices according to this disclosure can be of any suitable or desired degree for the number of different orientations with similar device shapes. Example shapes include circles, triangles, squares, pentagons, hexagons, heptagons, octagons, etc.

[0152] In the implantation or deployment configuration, the suture portion or paired suture portions may pass through the corresponding suture engagement feature in suture engagement feature 135. For example, as Figure 13 As shown in the example embodiments, individual suture portions 138a, 138b, 139a, 139b can be individually engaged with corresponding suture engagement features in suture engagement feature 135. Therefore, the process of balancing and / or distributing suture tension according to an example of this disclosure may involve passing suture portions and / or pairs of suture portions or other groups of suture portions through or otherwise engaging with the corresponding suture engagement features of the tension distribution device. After a suture portion has been engaged with its corresponding suture engagement feature, the process of balancing and / or distributing suture tension among the corresponding suture portions and / or groups of suture portions may involve binding or otherwise securing or fixing the different suture portions or groups of suture portions together on the proximal side of the tension distribution device 136, such as... Figure 13 As shown. For example, in some patients, suture portions associated with opposite sides of the tension distribution device 136 may be tied or otherwise secured / fixed together. Alternatively, adjacent suture portions or groups of suture portions may be tied or otherwise secured / fixed together on the distal side of the tension distribution device.

[0153] For convenience, the terms “distal” (or “proximal”) and “proximal” (or “near side”) are used for certain instances of the tension distribution device described herein. However, it should be understood that these names may be considered arbitrary for some embodiments. For example, it should be understood that a reference to the distal side of a tension distribution device may refer to any axial side of the tension distribution device, where the proximal side refers to the opposite axial side relative to the distal side of the mentioned tension distribution device. For convenience, with respect to certain relevant valve repair procedures, the proximal PS of the tension distribution device 136 is shown and described as the side of the device 136 generally facing the physician / surgeon, while the distal DS may generally face the heart and / or heart valve being repaired. In some cases, the distal DS may be considered the tissue contact side or surface. In conjunction with some examples of this disclosure, the distal side of the tension distribution device may be referred to as the “top side” (or “top surface” or “top side surface”), while the proximal side may be referred to as the “bottom side” (or “bottom surface” or “bottom side surface”). However, such terms are used for convenience and may or may not indicate any relational orientation of such devices. While some examples disclosed herein include disc-shaped tension distribution devices and / or other devices having an axial thickness and a plurality of generally flat surfaces separated by such axial thickness, it should be understood that references to "side" or "surface" of a tension distribution device according to this disclosure can refer to any axial region of the tension distribution device on the opposite side of the axial plane 502 associated with the tension distribution device 136. It should be clear that, with respect to the tension distribution device 136 and / or Figure 13 Any descriptions or terms relating to other aspects of the diagram are applicable to any other instances exemplified and described in connection with this disclosure.

[0154] The suture engagement feature 135 can advantageously allow the suture to slide through it. For example, such a feature 135 can be designed to reduce the amount of sliding friction experienced by the associated suture, thereby allowing the suture to move relatively freely along its length when engaged with the corresponding suture engagement feature. Therefore, when individual suture portions and / or groups of suture portions have been tied or otherwise secured / fixed to each other on the distal side DS of the tension distribution device 136, the fixing points (one or more) 137—through which the suture portions are secured to each other—can be allowed / permitted to slide or otherwise migrate toward one or more of the suture engagement features after the associated suture portions and / or groups of suture portions have been tied / fixed to each other. For example, as... Figure 13 As shown, the knot stack 137 coupling suture portion 139a and suture portion 138b can migrate over time to a position closer to one of the suture engagement features (through which the suture portion or group of suture portions passes or is otherwise engaged) – compared to a position further from the other of the suture engagement features 135 (through which the suture portion or group of suture portions passes or is otherwise engaged). This migration of the knot or other coupling or fastening mechanism (one or more) / device (one or more) can be caused at least in part by the tension difference between the respective suture portions. For example, a tighter suture portion and / or group of suture portions can be pulled distally with greater force than a looser suture portion and / or group of suture portions to which it is tied or otherwise secured, thereby pulling the coupling (e.g., knot or other fastening point) between the differently tensioned suture portions toward the suture engagement feature through which the tighter suture portion (one or more) and / or group of suture portions (one or more) passes or is otherwise engaged.

[0155] Migration of suture portions and / or knots (one or more) / couplers (one or more) (e.g., postoperative migration) can be used to balance / distribute tension between knotted / coupled suture portions and / or groups of suture portions. The terms “coupled” and “coupler” are used herein in their broad and general sense. For example, where a first feature, element, component, device, or member is described as coupled to a second feature, element, component, device, or member, such description can be understood to indicate that the first feature, element, component, device, or member or a portion thereof is physically / mechanically attached, secured, fastened, connected, linked, or associated with the second feature, element, component, device, or member or a portion thereof, or is unified with, associated with, integrated with, or at least partially embedded in or otherwise physically related to the second feature, element, component, device, or member or a portion thereof, whether directly or indirectly. "Coupled" can refer to any device, structure, form, tool, mechanism, means, location, equipment, or part or location thereof that at least partially facilitates and / or enables / realizes the coupling of two or more features, elements, components, devices, or members and / or portions thereof. In some examples and embodiments, this rebalancing of tension can be used to generate substantially equal tension between initially dissimilarly tensioned suture portions and / or groups of suture portions, thereby improving the performance / functionality of the suture implant device(s) and / or reducing the risk of injury and / or other health complications that may result from uneven suture tension, as detailed above. Furthermore, the suture tension distribution facilitated by the tension distribution device as disclosed herein ensures that no single suture portion or group of suture portions bears more than fifty percent of the total tensile load on the sutures engaged with the device.

[0156] about Figure 13In the example implementation, each of the example suture portions 138a, 138b, 139a, and 139b may represent a single suture strand, suture pair, or any other grouping of suture portions or strands. Furthermore, each of the example suture portions may be associated with a separate tissue anchor, or one or more of the example suture portions may be associated with a common tissue anchor. For example, suture pair 138 may include a first suture tail 138a and a second suture tail 138b associated with a single tissue anchor that can be implanted in a heart valve leaflet or other biological tissue, while suture pair 139 may include a first suture tail 139a and a second suture tail 139b associated with a single tissue anchor that can also be implanted in a heart valve leaflet (e.g., the same leaflet or another leaflet of the same heart valve) or other biological tissue. In other words, as with other examples disclosed herein, the suture portion of the example may represent any arrangement, configuration, and / or combination of suture portions associated with any grouping, configuration, arrangement, or number of tissue anchoring devices (e.g., large knots).

[0157] However, some suture tensioning solutions do not provide a balanced distribution of tension load on the sutures because all sutures are pulled by hand simultaneously to achieve the desired tissue anchor position and adequate reduction of mitral regurgitation. Examples of this disclosure advantageously allow surgeons to tension the suture tails of the tissue anchors to achieve proper occlusion and a balanced tension across all sutures, ensuring that no single suture bears the majority of the load.

[0158] Figure 14 A cross-sectional side view of a tension distribution device 146 engaged with suture 149, according to one or more examples, is shown. Different from... Figure 13 The image shows an example of a tension distribution device that engages at least four suture joining features 135 with suture portions (one or more). Figure 14 The tension distribution device 146 shown includes two suture joining features 145, with which suture portions 149 are respectively joined. The suture portions or groups of suture portions 149 are secured or otherwise coupled at fixing points 148 using one or more knots or other coupling / fixing mechanisms. Specifically, Figure 14 The example shows a knot stack 147, which may include multiple knots tied in series to form a stack (e.g., stacked on top of each other). As shown, a difference in tension between suture portions 149a and 149b can cause the coupling 148 to migrate toward one of the suture engagement features 145 and away from the other.

[0159] Figure 15 Top and side perspective views of a tension distribution device 150 according to one or more examples are shown. Figure 15Examples include four suture engagement features 155 uniformly distributed around an axial center point CP of device 150. The suture engagement features 155 may include orifices or holes through which sutures can pass or thread through. The suture engagement features 155 may be positioned at any desired radial distance r from the center point CP. In some examples, the suture engagement features 155 are advantageously positioned relatively close to the outer edge 158 of device 150 to provide a desired and / or maximized distance d between opposing engagement features (e.g., 155c, 155b).

[0160] In some examples, as shown, the tension distribution device 150 includes a solid form, which may have a button-like shape. In some examples, the tension distribution device 150 includes a form that is at least partially hollow. The tension distribution device 150 can have any suitable or desired axial shape, such as... Figure 15 The circular shape is shown. In some examples, the device 150 has a square or rectangular shape, wherein the stitching feature 155 may be located at or associated with a corner or midpoint of the side of the device. Any other suitable or desired shape, such as a star, ellipse, triangle, or any other type of shape, can also be implemented. As shown, the device 150 advantageously has rotational symmetry about the central axis CP.

[0161] The outer edge 158 of device 150 may be at least partially rounded, such as at its axial edges or corners. In some examples, the side surface 158 of device 150 presents a substantially flat and / or rounded surface, at least in a certain thickness dimension. The top surface 152 of device 150 may be substantially flat. In some examples, surface 152 is at least partially rounded or has certain topological features (in... Figure 15 (Not shown in the examples), which can assist in suture management and / or be used for other purposes or functions.

[0162] Figure 16 This shows one or more instances according to this disclosure. Figure 15 The diagram shows bottom and side perspective views of the tension distribution device 150. In some examples, the bottom side of the tension distribution device 150 is a substantially mirror image of the top side 152 of the device 150. For example, the device 150 may be axially symmetrical about its central axial plane.

[0163] The bottom surface 154 of the device 150 may be substantially flat. In some examples, surface 154 is at least partially rounded or has certain topological features (in... Figure 15(Not shown in the examples), which may assist in tissue junctions or pad junctions, or for other purposes or functions. In some examples, the bottom surface 154 is convex in one or more portions or regions to facilitate tilting or rotational contact with tissue, pads, or other surfaces it contacts in its implantation configuration. In some examples, the bottom surface 154 is concave in one or more portions or regions to facilitate mating with tissue or other surfaces it rests against.

[0164] Figure 17 The diagram shows a top or bottom view of a tension distribution device 170 comprising four suture joining features according to one or more examples. As described above, the various tension distribution devices disclosed herein may have any suitable or desired number of suture joining features. Figures 17 to 19 Different examples of suture tension devices with varying numbers of suture joining features are shown. Although Figures 17 to 19 The example suture joining feature is shown as an opening / hole; however, it should be understood that such instances may include or implement any suitable or desired type of suture joining feature as described in detail herein.

[0165] As described herein, the suture joining feature 175 can be arranged / positioned at any suitable or desired radius r. Regarding the implementation of the four features, as shown in the figures, the suture joining feature 175 can be positioned at a 90° interval from adjacent features. The distance d1 between opposing suture joining features (e.g., 175b, 175d) can generally be greater than the distance d2 between adjacent joining features (e.g., 175c, 175d). As with all examples of the tension distribution device in this disclosure, the suture joining feature 135 can be positioned at any suitable or desired distance d3 from the outer edge 178 of the device 170. Figure 17 The example shown has four-degree rotational symmetry in four similar quadrant blocks / regions.

[0166] Figure 18 The diagram shows a top or bottom view of a tension distribution device 180 comprising three suture joining features 185 according to one or more embodiments of the present disclosure. As described herein, the suture joining features 185 can be configured with any suitable or desired radius r. Regarding the implementation of the three features, as shown, the suture joining features 185 can be positioned at 120° intervals from adjacent features. Similarly... Figure 18 The embodiments of the example shown may involve binding or otherwise securing the suture portion or the suture portion that engages with the corresponding engagement feature 185 together in the central region of the device 180. Figure 18 The example shown has three-degree rotational symmetry.

[0167] Figure 19The diagram shows a top or bottom view of a tension distribution device 190 including two suture joining features 195 according to one or more embodiments of the present disclosure. As described herein, the suture joining features 195 can be set to any suitable or desired radius r. Regarding the implementation of the two features, as shown, the suture joining features 195 can be positioned 180° apart from adjacent features. Figure 19 The example shown has two-degree rotational symmetry.

[0168] Figure 20 The illustration shows bottom and side perspective views of a tension distribution device 200 including a convex protrusion 203 according to one or more embodiments of the present disclosure. The protrusion 203 can be used to provide a desired tissue interface for the tension distribution device 200, allowing the device 200 to tilt more easily to a certain extent than embodiments including a substantially flat bottom or distal surface. The protrusion 203 can cover any suitable or desired area of ​​the bottom / distal surface 204 of the device 200. In some examples, the protrusion 203 covers an area radially located within the region of the suture engagement feature 205. The convex protrusion 203 can have a curvature that promotes the rocking of the device 200. In some examples, the convex surface 203 can substantially cover the entire bottom surface 204 of the device 200. In such embodiments, the suture engagement feature 205 can be at least partially integrated with the convex surface 203. In some examples, the stitching feature 205 may include a hook, loop, or other wire-like protrusion or radial protrusion feature extending radially outward from the outer edge 208 of the device 200.

[0169] Figure 21-1 and Figure 21-2 A side view of an implanted tension distribution device 210 according to one or more embodiments of the present disclosure is shown. The tension distribution device 210 has a convex protrusion 213. Figure 21-1 In one embodiment, the suture portion 219 may pass through or otherwise engage with the suture engagement feature 215 of the tension distribution device 210, wherein the suture portion is tied or otherwise secured to the tension distribution device 210, such as in the area associated with the corresponding suture engagement feature 215. That is, according to Figure 21-1 In some embodiments, the suture portions and / or groups 219 of opposing or separate suture engagement features 215 on the proximal or top side 202 of device 210 may not be tied together. For example, suture pairs or individual suture portions may be knotted to prevent the suture from being withdrawn distally through the suture engagement feature 215. That is, the diameter of the knot in the knot stack (or other type of suture coupling) 217 ​​may be larger than the diameter of the corresponding portion of the suture engagement feature 215.

[0170] Unlike some other examples disclosed herein, suture balance / distribution can be achieved by tilting and / or rotating the device 210 using the convex protrusion 213, rather than by migrating the proximal suture knot across the top or proximal surface or other areas of the device 210. Greater tension in one suture portion or group of suture portions 219b compared to other suture portion groups of suture portion 219a can lead to... Figure 21-1 The device 210 shown is tilted. For example... Figure 21-1 As shown, tilting the device 210 can shorten the distance between the fixing point of the knot 217b associated with the suture portion (one or more) 219b and the distal target anchor point (not shown), thereby reducing its tension. Conversely, the distance between the suture fixing point of the knot 217a and the distal target anchor point (not shown) associated with the suture portion (one or more) 219a can be increased by tilting the device 210, thereby increasing the tension of the suture portion (one or more) 219a.

[0171] according to Figure 21-2 In this implementation, the tension balance / distribution between the suture portions 219a and 219b can be achieved by tilting the tension distribution device 210 and by migrating the suture fixing points associated with the knot or other suture coupling mechanism 217. That is, the suture portions can pass through the corresponding suture engagement feature 215 and be secured to the top / proximal side 202 of the device 210. For example, greater tension in the suture portions (one or more) 219b can cause the device 210 to tilt in the direction of the suture engagement feature 215b, such that the suture portions pass through or otherwise engage with the suture engagement feature 215b. This differential tension supporting the suture portions (one or more) 219b can further cause the suture coupler 217 to migrate toward the suture engagement feature 215b. The combined effect of the tilting of the device 210 by the convex protrusion 213 and the migration of the knot 217 allows for a significant rebalancing of tension.

[0172] Figure 22 A side view of a tension distribution device 226 having a lateral suture engagement feature 225 according to one or more embodiments of the present disclosure is shown. Unlike certain other embodiments of the present disclosure, where the suture engagement feature is oriented to provide passage of a suture portion through the bottom or distal side of the tension distribution device, the device 226 includes the suture engagement feature 225, which allows the suture portion to pass through, thread through, or engage with the side surface or portion 228 of the device 226 and / or to engage with it in other types of ways through the side surface or portion 228 of the device 226. For example, as... Figure 22 As shown, suture portions 229a, 229b may pass through tissue wall 221 and are below and / or around, or below / distal to, the base 224 of device 226.

[0173] When suture portions and / or groups of suture portions 229 are engaged with lateral suture joining features 225, such suture portions may be coupled to each other at coupling point 222, such as by binding with one or more knots (e.g., not stacks) 227. The coupling 227 may tend to migrate to some extent between the lateral suture joining features 225a, 225b, thereby at least partially balancing and / or distributing the tension between the suture portions(one or more) 229a and 229b. For example, the coupling 227 (e.g., knot stacks) may be permitted to slide or move on or above the base 224. Suture portions 229a, 229b from opposite / opposite and / or adjacent suture joining features may be bound together.

[0174] Figure 23 Top and side perspective views of a tension distribution device 236 having a lateral suture joining feature 235 according to one or more embodiments of the present disclosure are shown. In some examples, the device 236 includes a base 234 and one or more circumferential / peripheral side portions 238. Although the side portions 238 are shown as continuous around the circumference / periphery of the device 236, in some examples, the side portions (one or more) may be associated only with one or more arc lengths of the circumference / periphery of the device 236. For example, the side portions may exist in areas of the suture joining feature 235 where there is a circumferential interruption. Furthermore, although the device 236 is in Figure 23 and Figure 24 The example shown includes a base portion 234, but in some examples, the device 236 does not include a base. For example, the device 236 may include a loop form having one or more lateral / radial suture joining features without an associated base.

[0175] although Figure 23 and Figure 24 The tension distribution device 236 is shown to have an axial shape that is generally circular, but as with other embodiments of this disclosure, the device 236 may have any suitable or desired shape. As implemented in distributing tension between suture portions and / or groups of suture portions (e.g., suture pairs), suture portions from opposing suture joining features (e.g., 235b, 235d) may be coupled / tied, or suture portions from adjacent suture joining features may be coupled, connected, or tied, as with suture portions 239b connected / coupled between suture joining features 235a and 235b.

[0176] Figure 24 This shows one or more instances according to this disclosure. Figure 23 The tension distribution device 236 is shown in both bottom and side perspective views. Figure 24In the examples, base 234 is shown as substantially flat over its area. However, in some examples, the tension distribution device 236 includes a base with a convex surface or region configured to facilitate or promote tilting or rocking of the device when positioned against tissue, pads, or other surfaces. In certain cases, this external topology of base 234 can provide increased tension distribution functionality. As with other embodiments of this disclosure, tension distribution device 236 may have any number and / or arrangement of suture engagement features.

[0177] Figure 25 A side view of a tension distribution device 256 having a covering feature 253 according to one or more embodiments of the present disclosure is shown. Although the tension distribution device 256 is shown as having a lateral suture joining feature 255, as described in detail herein, it should be understood that the suture joining feature 255 may extend through the base portion 254 of the device rather than the side 258. Furthermore, any other suitable or desired configuration of suture joining feature may be used in conjunction with and / or combined with the tension distribution device 256.

[0178] like Figure 25 As shown, the tension distribution device 256 includes a cover portion 253, which may be disposed and / or positioned proximal to or near the device 256. The cover portion 253 may be used to accommodate at least a portion of the suture portion 259 that engages with the suture engagement feature 255. For example, as... Figure 25 As shown, one or more knots and / or other fixation mechanisms or points implemented to connect / couple corresponding suture portions can be accommodated within a cavity formed in the base 254, sides 258, and cover portion 253. The cover portion 253 can be used to protect the suture and / or coupler 257 from certain environmental parameters / conditions and / or help prevent the suture and / or coupler 257 from forming embolisms and / or other undesirable interactions with the patient's physiology. In some examples, the cover portion 253 includes an opening or other feature 252 through which the suture tail can pass. Although the coupler 257 is shown within a cavity of the device 256, in some examples, such a coupler can be implemented externally to the device 256—such as on the cover portion 253. For example, the diameter of the coupler / knot 257 can be larger than the diameter of the opening 252, thereby preventing the coupler 257 from being pulled back through the opening 252.

[0179] Figure 26 Top and side perspective views of a tension distribution device 266 having covering feature 263 according to one or more embodiments of this disclosure are shown. Similar to the above... Figure 25 Disclosed device 256, Figure 26 and Figure 27The tension distribution device 266 shown includes a cover feature 263. It should be understood that the cover feature of the tension distribution device disclosed herein may include a removable cover separate from the base and / or side portions of the tension distribution device, or may be integrated with the base and / or side portions, such as in an integral form. In some examples, tension distribution devices according to aspects of this disclosure include: a proximal / upper cover portion having an associated orifice; and one or more side portions coupled to and / or configured to be coupled to the cover portion, without having an associated base. That is, some tension distribution devices may have an open bottom shape or configuration.

[0180] Figure 27 Displays based on one or more instances Figure 26 Top and side perspective views of the tension distribution device 266, wherein the suture portions 269a, 269b engage with certain suture joining features 265 and are coupled together according to various aspects of this disclosure. The openings 262 of the cover 263 may be configured to allow the suture portions and / or couplings / knots to pass through them.

[0181] Figure 28 Top and side perspective views of a tension distribution device 286 having one or more proximal suture channels 282 according to one or more embodiments of the present disclosure are shown. In some examples, tension distribution devices according to various aspects of the present disclosure include certain channels, grooves, paths, etc., configured to receive and / or guide / accommodate portions of the suture, thereby facilitating a desired tension distribution / balance. Although the channels 282 of the device 286 are shown and described as being located proximal or superior to the device 286, such channels may be associated with any suitable or desired region or portion of the device 286. In some examples, the channels 282 are at least partially closed. For example, the channel may be closed in at least a portion of the region 281 of the channel between the outer periphery of the device 286 and the central region 283. Thus, the channel 282 can be considered as part of the suture engagement feature 285 of the device 286.

[0182] Channel 282 may have any suitable or desired size, shape, width, depth, curvature, orientation, etc. Furthermore, although the channel is shown as traversing the diameter of the device 286 from opposite portions or regions of its periphery, it should be understood that the channel may follow any suitable or desired path through and / or along the tension distribution device. For example, although channel 282 is shown as providing a path connecting opposite (e.g., diametrically opposite) suture joining features 285, in some examples, the channel is configured to connect adjacent suture joining features in a direct manner, meaning that such a connection path does not need to travel through the central region 283. Suture management channels according to various aspects of this disclosure may include any suitable or desired terrain shape and / or configuration. Channels as shown and / or described above may be incorporated and / or implemented in combination with any of the examples of tension distribution devices and / or components disclosed herein.

[0183] The tension distribution device 286 may include any suitable or desired type of suture joining feature 285. In some examples, such as Figure 28 As shown, device 286 may not have separate suture engagement features other than the entry portion of channel 282 and the channel itself. Alternatively, device 286 may include lateral openings or other suture engagement features associated with the periphery / side 288 of device 286. Alternatively, device 286 may include openings through the base or other types of suture engagement features associated with the base or bottom surface of device 286.

[0184] With the suture portion 289 coupled and disposed in the channel 282, the coupling element (e.g., knot stack) 287 can be permitted to slide within one or more areas of the channel 282, thereby distributing tension as described in detail herein. In some examples, the tension distribution device 286 includes a gasket having a suture management channel as described herein (e.g., formed in or attached to the gasket).

[0185] Figure 29 A side view of a tension distribution device 296 according to one or more embodiments of the present disclosure is shown. The tension distribution device 296 has one or more proximal suture channels 292 that engage with one or more suture portions 299. As implanted according to certain surgical procedures, the tension distribution device 296 can engage with the suture portions or groups of suture portions 299 by means of or utilizing any suitable or desired suture engagement features according to the present disclosure. The suture portions 299 can be coupled in any suitable or desired manner, wherein such coupling elements 297 can be permitted to migrate within one or more channels to distribute or balance the tension of the respective suture portions 299a, 299b.

[0186] Figure 30A side view of a tension distribution device 306 disposed on a pad 302 according to one or more embodiments of the present disclosure is shown. Although certain embodiments are disclosed herein in the context of implanted tension distribution devices—with which a suture portion engages—where the tension distribution device is disposed on or adjacent to a tissue wall or surface (e.g., the external ventricular wall), in some embodiments, tension distribution devices according to various aspects of the present disclosure may be disposed on a pad 302, which may generally be disposed between the tension distribution device 306 and the associated tissue wall 301. For example, as... Figure 30 As shown, the suture portion 309 may pass through the tissue wall 301 and further through one or more portions or regions of the pad 302, and engage with a tension distribution device 306 proximal to the pad 302. The tension distribution device 306 may conform to any feature or instance disclosed in this disclosure with respect to the suture engagement feature 305 and / or other features or configurations of the device 306. The suture portion 309 may be coupled to the tension distribution device 306 proximal to the tension distribution device 306, such as a knot or other coupling element 307, according to this disclosure.

[0187] Figure 31 Perspective views of a tension distribution device 316 according to one or more examples are shown in bottom and side views. As exemplified and described above, certain examples of this disclosure are presented in the context of a circular tension distribution device. Furthermore, certain examples are disclosed herein in the context of tension distribution devices comprising an even number of suture joining features, wherein such features facilitate coupling of paired suture portions and / or groups of paired suture portions. However, as mentioned and described in detail herein, such devices may include suture joining features of any suitable or desired shape, number, and / or arrangement. Tension distribution device 316 of Figure 31 The examples shown provide examples of tension distribution devices with non-circular shapes and / or a non-even number of suture joint features.

[0188] exist Figure 31 In one example, the tension distribution device 316 includes an overall triangular shape with a corner portion 317 associated with certain seam joining features 315. Although the corner portion 317 of the device 360 ​​is shown to have an overall flat configuration, such features can be rounded or have any other suitable or desired shape or configuration.

[0189] Although the example is a lateral suture joining feature, feature 315 can be an axially oriented suture joining feature that passes through the base, as described in detail herein. Figure 31 Certain suture portions are shown that engage with the tension distribution device 316 and are coupled to various aspects of this disclosure. For convenience, Figure 31The image shows suture pairs 319 respectively engaged with suture engagement feature 315. However, it should be understood that each suture engagement feature 315 can be engaged with any number of suture portions. The three suture pairs 319 can be knotted or otherwise coupled together on the upper side or proximal side of the tension distribution device 316—such as by knotting or other coupling devices / mechanisms.

[0190] In some examples, the tension distribution device 316 includes one or more channels or guide paths 312 to facilitate the administration and / or functionality of the device 316. The shape and / or configuration of the device 316 may allow the coupling of the suture pairs 319 to generally migrate along one or more of the suture engagement features 315, thereby at least partially balancing and / or distributing the tension between the suture pairs.

[0191] Figure 32 A perspective view of at least the base of a tension distribution device 320 according to one or more embodiments of the present disclosure is shown. For example, the exemplary device 320 may be the base component of a multi-component tension distribution device, or it may be a tension distribution device that is itself integrated with itself. An example of the tension distribution device 320 is a device including three suture joining features 325 associated with three triangular corner regions 327. However, as with other embodiments disclosed herein, the tension distribution device and components are like... Figure 32 The device 320 shown may include any number of suture joining features and / or their arrangement.

[0192] The device 320 includes a plurality of suture channels 322, which can facilitate the management of suture portions engaged with the device 320. Although suture channels 322 are exemplified in some examples, the device 320 may not have channels. In some examples, the device 322 includes a central aperture 323, which can be used for holding and / or engaging suture portions for various purposes. In some examples, the device 320 may serve as a top cover portion of a tension distribution device. In the illustrated examples, suture engagement features include a peripheral recess into which suture portions and / or groups of suture portions can be placed. However, any suitable or desired type of suture engagement feature may be implemented with respect to the device 320, including an axial aperture that allows suture portions to pass through the plane of the device 320.

[0193] Figure 33A perspective view of at least a portion of a tension distribution device 330 including a lateral suture joining feature 335, according to one or more embodiments of the present disclosure, is shown. In some examples, the device 336 includes a base 334 and one or more peripheral side portions 338. Although the side portions 338 are shown as continuous around the periphery of the device 336, in some examples, the side portions (one or more) may be associated only with one or more regions of the periphery of the device 336. For example, the side portions may be present in regions of the suture joining feature 335 where there are peripheral gaps / interruptions. Furthermore, although the device 336 is in Figure 33 The example shown includes a base portion 334, but in some examples, the device 336 does not include a base. For example, the device 336 may include a band or loop having one or more lateral / radial suture joining features without an associated base.

[0194] although Figure 33 The tension distribution device 336 is shown in an axially triangular shape with flat corners 337, but as with other embodiments of this disclosure, the device 336 may have any suitable or desired shape. As implemented in distributing tension between suture portions and / or groups of suture portions (e.g., suture pairs), suture portions from all suture joining features 335 may be bound / coupled together with couplings 331 of suture portions 339 as shown, or suture portions from adjacent suture joining features (e.g., 335a and 335b) may be coupled.

[0195] When the various coupled suture portions 339 have uneven tension, at least initially after coupling, the coupling member 331 can generally migrate along the direction of the suture engagement feature (one or more) joined by the suture portions (one or more) that are relatively more tense. For example, this migration can reflect a vector corresponding to the relative tension of the sutures. Thus, if suture portion (one or more) 339c initially has the highest tension and suture portion (one or more) 339b has the lowest tension, while suture portion (one or more) 339b has some tension between the highest and lowest, then the coupling member 331 can migrate to the maximum extent toward the suture engagement feature 335c and to a smaller extent toward the suture engagement feature 335a. That is, the migration force experienced by the coupling member 331 (e.g., force vector (one or more)) can be the greatest in the direction of feature 335c and to a smaller extent in the direction of feature 335a.

[0196] Figure 34 A perspective view of at least a portion of a tension distribution device 340 according to one or more embodiments of the present disclosure is shown. Figure 34Examples include three suture joining features 345 positioned and / or oriented along the axial direction. That is, the position and / or orientation of the suture joining features 345 may differ from... Figure 33 Feature 335 is generally oriented radially. Therefore, suture joining feature 345 can be considered as an opening or feature through the base. Example device 340 can be a base component of a multi-part tension distribution device, or it can be a tension distribution device that neutralizes itself. As implemented in distributing tension between suture portions and / or groups of suture portions (e.g., suture pairs), suture portions from all suture joining features 345 can be coupled (e.g., tied) together, or suture portions from adjacent suture joining features can be fixed, connected, tied, or otherwise coupled.

[0197] Figure 35 A side view of a tension distribution device 356 engaged with multiple suture portions according to one or more embodiments of the present disclosure is shown. Figure 13 Multiple suture portions (or pairs of suture portions or other groups of suture portions) 359 that engage with device 356 are shown. For example, as described in detail herein, such suture portions 359 may be associated with corresponding tissue anchors such as heart valve leaflet anchors. In some embodiments, suture portions 359 may traverse tissue wall 351 and may be anchored on the proximal side 55 of tissue wall 351, thereby securing the corresponding suture pairs and / or suture portions in a tension configuration between the tension distribution device 356 at the proximal end and the distal target tissue anchorage position (not shown) at the distal end.

[0198] As described above in conjunction with certain other examples of this disclosure, the tension distribution device 356 may be an generally triangular device. The tension distribution device 336 may or may not include proximal / upper cover components or portions.

[0199] In some examples, the tension distribution device 356 includes certain suture engagement features 355 configured to allow suture portions and / or pairs / groups of suture portions to engage with it in a manner that allows the suture portions(one or more) to slide longitudinally through the suture engagement feature. In the illustrated example, the suture engagement feature 355 includes a lateral opening through which the suture portions and / or pairs / groups of suture portions can be threaded in a certain way. Unlike some other embodiments of this disclosure—where the suture engagement features are oriented to provide passage of the suture portions through the bottom or distal side of the tension distribution device—the device 356 includes suture engagement features 355 that allow suture portions to pass through, thread through, or engage with the side surfaces or portions (one or more) 358 of the device 356 and / or engage with it in other types of ways through the side surfaces or portions (one or more) 358 of the device 356. For example, as Figure 35 As shown, the suture portion 359 can pass through the tissue wall 351 and is below and / or around the base 354 of the device 356, and / or on its underside (e.g., its bottom or distal side).

[0200] When the suture portions and / or groups of suture portions engage with the lateral suture engagement feature 355, such suture portions can be coupled to each other at the coupling point 352, for example, by binding with one or more knots 357 (e.g., knot stacks). The coupling point 352 may tend to migrate to some extent on or within the device 356, between the lateral suture engagement features 355, thereby at least partially balancing and / or distributing the tension between the suture portions (one or more) 359. For example, the coupling 352 (e.g., knot stacks 357) may be permitted to slide or move on or above the base 354. The suture portions 359 may be all bound together, or may be bound / coupled in pairs or groups of pairs of suture portions.

[0201] Figure 36 This is a flowchart illustrating a process 360 for distributing or balancing tension among multiple suture portions and / or groups of suture portions, according to one or more embodiments of this disclosure. At block 362, process 360 involves implanting one or more tissue anchors into a patient's biological tissue, wherein each of the tissue anchors (one or more) is associated with one or more suture tails / parts. For example, the one or more tissue anchors may include a knotted heart valve leaflet anchor configured to be implanted in the leaflet tissue and tethered to some extent by the corresponding suture portion (one or more) associated therewith.

[0202] At block 364, process 360 involves engaging two or more suture portions and / or groups of suture portions (e.g., suture pairs) with corresponding suture engagement features of a tension distribution device according to aspects of this disclosure. For example, in a heart valve repair procedure, the suture portions may be tethered distally by corresponding tissue anchors, wherein the suture portions (one or more) pass through a tissue wall such as the ventricular wall of a patient's heart to tether the tissue anchors (one or more). Thus, a portion of each suture portion (one or more) may generally be positioned externally / proximal to the tissue wall through which the suture portion passes.

[0203] Engaging the suture portion with a corresponding suture engagement feature of the tension distribution device may involve threading the suture portion through an orifice-type engagement feature, or any other suitable or desired type of engagement feature configured to physically accommodate and / or secure the suture portion, while allowing the suture portion to slide relatively freely longitudinally through the engagement feature. As described in detail herein, the engagement feature may be laterally oriented or predominantly axially oriented.

[0204] At block 366, process 360 involves coupling suture portions and / or groups of suture portions that engage with corresponding suture engagement features of the tension distribution device in a certain way. For example, the operation (one or more) associated with block 366 may involve binding one or more knots (e.g., knot stacks) to secure / couple individual suture portions and / or groups of suture portions to each other across an area and / or path on or within the tension distribution device 356.

[0205] At box 368, process 360 involves allowing the coupling of the suture portion engaged with the tension distribution device to migrate on and / or within the tension distribution device, thereby balancing and / or distributing the corresponding tension load of the suture, resulting in a more uniformly distributed / balanced tension across the suture portion.

[0206] Parallel plate tension balancing device and process

[0207] In some embodiments, this disclosure relates to systems, apparatus, and methods for balancing tension between multiple sutures and / or groups of sutures. Figure 37 A side view of a tension balancing device 370 according to one or more examples is shown. Device 370 can be considered a parallel plate tension balancing device and includes a first 374 plate structure and a second 374 plate structure, which can be used or implemented to determine and / or set the level of balancing tension in the seam portion engaging with the balancing device 370. The terms “plate” and “plate structure” are used herein according to their broad and general meaning and can refer to any structure in the form of a layer, slab, sheet, panel, or other structure that is generally or at least partially flat relative to one or more of its portions, such as one or more of its axial surfaces or faces.

[0208] The tension balancing device 270 includes a support shaft component 375, which may have any suitable or desired shape or form. Specifically, the support shaft 375 may be advantageously configured to facilitate tilting and / or rocking of one of the plates 372, 374 relative to the other. For example, in some examples, the support shaft 375 is attached to or otherwise integrated into one of the plate structures 372, 374. Figure 37 As shown, the support shaft 375 can be attached to and / or integrated with the plate structure 374. Although the plate structure 374 is... Figure 37 The structure is shown as a base plate, but it should be understood that plate structures 372 and 374 can be oriented relative to the axial direction in any suitable or desired manner or order. Therefore, such references to base plate structure, top plate structure, near-side plate structure and / or far-side plate structure are merely for convenience of naming, and it should be understood that such references can refer to any plate structure of the parallel plate tension balancing device according to the embodiments of this disclosure.

[0209] In some examples, the support shaft 375 is hemispherical. The support shaft component 375 can be removed or detached from the plate structure 374. However, in some examples, the support shaft 375 can be fixed to and / or integrated with the plate structure 374 in some way. For example, the support shaft 375 can be fixed to the plate structure 374 such that the plate structure 374 cannot tilt relative to the support shaft 375. Instead, the associated tilt between the plate structure 372 and the plate structure 374 can be achieved and / or facilitated by the tilt of the plate structure 372 on and relative to the support shaft 375. In general, the plate structure associated with the support shaft component can be referred to as the "base" plate structure, and the plate structure configured to be balanced on the support shaft component can be referred to as the "balanced" plate structure.

[0210] One or both of the plate structures 372 and 374 may have certain associated suture fixing features 375, which are configured to secure the suture to them in such a way that they at least partially restrict the sliding and / or other longitudinal movement of the suture portion 373 engaged with them relative to one or more components of the suture fixing feature 375. The suture fixing feature 375 may have any suitable or desired form or configuration designed to engage the suture with its respective components. For example, in the illustrated example, the suture fixing feature 375 includes a rod 377 or any other type of shank, spindle, spool center, reel, or similar structure around which the suture may be at least partially wrapped or abutted to secure or hold the suture. Feature 375 further includes a flange member 376, which may be sized and / or configured to restrict the movement or sliding of the suture portion engaged with feature 375 radially outward from the associated plate structure (e.g., in the axial direction relative to rod 377), thereby maintaining engagement of the suture with the corresponding suture fixing feature. Therefore, the suture can be at least partially secured to the suture fixing component (one or more) 375 by wrapping the suture around the rod 377 once or multiple times to achieve sufficient friction thereon, so as to prevent the suture portion from sliding longitudinally through / within the fixing feature.

[0211] It should be understood that any type of suture securing feature can be implemented in conjunction with examples of this disclosure. For example, in some examples, spring-loaded and / or other forces / components may be implemented to press the flange 376 radially inward (e.g., axially inward relative to the axis of the rod 377) to secure the suture. In some examples, the suture engagement feature 375 includes spring-loaded clips, clamps, supports, levers, strips, bands, etc., configured to secure the suture portion engaged therewith between the flange 376 and the periphery of the plate structure. In some examples, the suture securing feature 375 includes certain tension adjusting features, such as tuning pins or pins. In some examples, the tuning feature includes attached or removable adjusting levers configured to increase the tension of the suture by winding and / or unwinding the suture around a pin, rod, or similar structure. Such features provide fine adjustment of the suture tension. In some examples, the suture can be released from the fixation by actuation or engagement of a button, tab, lever, etc., wherein the release of such a component results in the suture tension being fixed / locked. Typically, examples of the suture fastening features according to this disclosure advantageously allow for selective locking / fastening and unlocking / unlocking of the suture to the corresponding plate structure by any means or mechanism (including those described above).

[0212] In some examples, the suture fixing feature is associated with only one of the two plate structures of device 370. That is, the peripheral suture fixing feature may be associated with any one or both of plate structures 372 and 374. In some examples, both plate structures 372 and 374 include and / or have associated suture fixing features therewith, although a suture fixing feature associated with only one of the plate structures can be used to partially fix the suture when balancing the tension in the suture, while the suture may only contact the suture fixing feature associated with the other plate structure without being fixed to it. In some examples, the suture is fixed only to the suture fixing feature associated with the balancing plate structure.

[0213] When the suture 379 is fixed to a suture fixing feature 375 associated with at least one of the plate structures 372, 374, the relative inclination between the plate structures can provide an indication of the relative tension of the suture fixed thereto. Therefore, by increasing and / or decreasing the tension on the suture engaged with the device 370 to make the plate structures 372, 374 approximately parallel to each other, the suture tension across the suture fixed to the device 370 can be approximately balanced.

[0214] The support shaft 375 is shown in a dome-shaped hemispherical form, which can cause the plate to tilt according to the functionality of the device 370. However, it should be understood that the support shaft component of the tension balancing device according to this disclosure can have any suitable or desired shape and / or form. For example, the support shaft can have a tapered shape / form, or any other form including a central apex. Furthermore, in some examples, the support shaft can have an eccentric apex, which can allow for designed uneven tension between the seams.

[0215] The parallel plate tension balancing device disclosed herein can advantageously inform the surgeon which sutures are tighter and which are looser. The surgeon can strive to tension all sutures sufficiently evenly so that the two plates are substantially parallel to each other, or to make them more parallel. Furthermore, although... Figure 37 The diagram shows four suture fixing features for a given plate structure, but the plate structure can have any number of suture fixing features, such as two, three, or four. The parallel plate tension balancing device according to this disclosure can be configured to attach to a tourniquet, thereby providing the desired clamping to the device. For example, the plate structure fixed to the tourniquet can act as a relatively stationary plate, while another plate / rotatable plate can intersect with the stationary plate interface via a pivot associated with either the stationary or rotatable plate. In some examples, sutures can be looped through and pressed against the suture fixing features of both the stationary and rotatable plates.

[0216] Figure 38A base / support portion 384 of a tension balancing device according to one or more embodiments of the present disclosure is shown. Although referred to as a base component in some contexts herein, it should be understood that the plate structure associated with the support component of the tension balancing device can be an upper, lower, top, bottom, or otherwise oriented structure. The plate structure 384 may include an inner surface 388 that may be at least partially flat. Typically, the support component 383 may be positioned and / or disposed at the axial center of the plate structure 384. Such positioning can advantageously provide a central pivot point or apex for relative tilting of the plate structure. In some examples, the support component 383 may be offset from the axial center of the plate structure 384. For example, such offset may be implemented to result in a desired tension difference for certain seams, such that greater tension may be required for some seams integrated with the device 384 to produce a parallel plate structure.

[0217] The pivot member 383 may be a hemispherical protrusion, or any other shape that at least partially approximates a sphere. This shape of the pivot 383 can advantageously provide 360° tilting and / or pivoting in all directions. In some examples, the pivot 383 is designed to allow tilting only in certain directions. For example, the pivot 383 may include a semi-cylindrical shape configured to allow pitching or tilting, but not both. For example, in instances comprising only two suture fixing features and configured to produce balance only for two suture portions and / or groups of suture portions, it is desirable to restrict the tilting action associated with the device to tilting in the direction of such suture fixing features, while disallowing tilting in directions orthogonal to them. The pivot 383 may cover only a portion of the inner surface 388 of the plate structure 384, or may optionally cover substantially all of the inner surface 388 of the structure 384.

[0218] Although the example includes multiple suture fixing features 385, in some examples, the substrate structure 384 may not include suture fixing features. Furthermore, although in Figure 38 The diagram shows a pin-type fixing feature, but it should be understood that the plate structure 384 may include other types of suture fixing and / or suture engagement features, such as openings, hooks, etc. For example, the base 384 may include a suture engagement feature configured to receive a suture / suture portion without necessarily fixing such a suture portion. That is, such a feature allows the suture portion engaged with it to slide / move longitudinally within such a feature when engaged with it.

[0219] Figure 39A perspective view of the balancer portion 392 of a tension balancing device according to one or more embodiments of the present disclosure is shown. The plate structure 392 may include an internal surface 398 that may be at least partially flat. In some examples, the balancer structure 392 includes a recess or concave surface 393 configured and designed to receive / retain at least a portion of a support member of a corresponding base plate structure. The recess 393 can be used to position opposing plate structures of the tension balancing device in axial alignment with each other. The recess 393 can further be used to facilitate tilting / rotation of the balancer plate 392 about the support member of the base plate structure. In some examples, the balancer plate structure 392 does not include the shown recess / concave surface feature 393. That is, in such examples, tilting of the balancer plate structure 392 on the support member of the base plate structure may occur at the interface between the support of the base structure and the flat internal surface 398 of the balancer structure.

[0220] Typically, the recess / concave surface 393 can be positioned and / or disposed at the axial center of the plate structure 392 to align with the support shaft component 384 of the base structure (see...). Figure 38 This positioning can advantageously provide a central pivot point or area for relative tilting of the plate structure. The recess / concave surface 393 can have a hemispherical shape, or any other shape that at least partially approximates a sphere. This shape of the pivot 323 can advantageously provide 360° tilting and / or pivoting in all directions. In some examples, the recess / concave surface 393 is designed to allow tilting only in certain directions. For example, the recess / concave surface 393 can have a semi-cylindrical shape to allow pitching or tilting, but not both. For example, in instances comprising only two suture fixing features and configured to produce balance only for two suture portions and / or groups of suture portions, it is desirable to restrict the tilting action associated with the device to tilting in the direction of such suture fixing features, and not to allow tilting in directions orthogonal to them.

[0221] Although the example includes multiple suture fixing features 395, in some examples, the balancer portion 392 may not include suture fixing features. Furthermore, although in Figure 39 The diagram shows a pin-type fixing feature, but it should be understood that the balancer plate structure 392 may include other types of suture fixing and / or suture engagement features, such as orifices, hooks, etc. For example, the balancer 392 may include a suture engagement feature configured to receive a suture / suture portion without necessarily fixing such a suture portion. That is, such a feature allows the suture portion engaged with it to slide / move longitudinally within such a feature when engaged with it.

[0222] The corresponding plate structure of the parallel plate tension balancing device according to various aspects of this disclosure can have any suitable or desired number, arrangement, configuration and / or type of suture fixing features. Figure 40The illustration shows a component 400 (e.g., a base or balancer plate structure) of a tension balancing device including four suture fixing features 405, according to one or more embodiments of this disclosure. Including, as... Figure 40 In some examples of the four seam fixing features in the instance, such features can be positioned at or near the periphery of the plate structure 400 and evenly distributed circumferentially, wherein adjacent seam fixing features are offset by approximately 90°, such as... Figure 40 As shown in the figures. The plate structure of the tension balancing device according to an example of this disclosure can advantageously have rotational symmetry, as illustrated in the figures.

[0223] Figure 41 The illustration shows a component 410 (e.g., a base or balancer plate structure) of a tension balancing device including three suture fixing features 415, according to one or more embodiments of this disclosure. Including, as... Figure 41 In some examples of the three seam-fixing features 415 in the instance, such features 415 can be positioned at or near the periphery of the plate structure 410 and evenly distributed circumferentially, wherein adjacent seam-fixing features are offset by approximately 120°, such as... Figure 41 As shown. Figure 42 The illustration shows a component 420 (e.g., a base or balancer plate structure) of a tension balancing device including two suture fixing features, according to one or more embodiments of this disclosure. Including, as... Figure 42 In some examples of the two stitching features 425 in the instance, such features 425 may be positioned at or near the perimeter 421 of the plate structure 420 and evenly distributed circumferentially, wherein the stitching features 425 are offset by approximately 180°, such as... Figure 42 As shown.

[0224] Figure 43 A component 430 (e.g., a base or balancer plate structure) of a tension balancing device including a slit-type suture fixing feature 435 is shown according to one or more embodiments. The plate structure 430 may include any number and / or configuration of suture fixing / engaging features 435, configured to receive suture portions therein and retain them at least partially in a fixed and / or secured position by frictional engagement. For example, the suture may be pulled into a recess of a corresponding suture fixing feature 435, wherein the width of the slot / slit 435 is such that at a certain depth within the slot / slit, its walls contact and to some extent retain the suture portion, thereby providing fixation functionality according to various aspects of this disclosure.

[0225] Despite Figure 43The slit / groove type suture fixing feature is shown, but it should be understood that other types of friction fit features can be implemented according to the examples of this disclosure. For example, such features may be cut into the plate structure 430 and / or otherwise integrated with the plate structure 430, and / or attached to its perimeter 431. In some examples, feature 435 may be sized and / or configured to accommodate the suture portion therein, without necessarily fixing such a portion. For example, feature 435 may be used to some extent to hold the suture portion in a desired area while still allowing the suture portion to slide longitudinally.

[0226] Figures 44 to 48 Side and perspective views of various aspects of the tension balancing device 440 subjected to various suture tension conditions, according to one or more examples, are shown respectively. Figures 44 to 48 The illustrations relate to certain use cases of tension balancing devices according to various aspects of this disclosure, and are provided to further illustrate various aspects of the operation of certain parallel plate tension balancing devices.

[0227] Figure 44 A tension balancing device 440, comprising a first 442-plate structure and a second 444-plate structure, is shown, as described in detail herein. Figure 44 The downward arrows shown at the bottom of the diagram indicate the corresponding tension associated with the suture location adjacent to such arrows. For example, in Figure 44 In a particular configuration, the tension t1 associated with suture 449 is shown to be equal. Therefore, when the suture is fixed to the suture fixing feature 445 associated with the balancer plate structure 442, the balancer plate structure 442 can be approximately parallel / balanced relative to the base / support plate structure 444. Although suture 449 is shown fixed to the suture fixing feature 445 associated with the balancer plate structure 442, it should be understood that in some embodiments, the suture may instead be fixed to the suture fixing feature associated with the base / support plate structure 444. That is, to indicate suture tension balance / distribution with relative inclination, the suture may advantageously be fixed to one of the plate structures, rather than both. Furthermore, it may be advantageous for the plate structure to which the suture is not fixed to to have a stable / secure position. Therefore, in some examples, at least one of the plate structures is fixed to a tourniquet or other relatively stable structure. Furthermore, in some embodiments, it may be desirable to keep the plate structure stationary (e.g., Figure 44 The base / support plate structure 444 is oriented approximately orthogonal to the orientation of the sutures extending from its respective tissue anchor. In cases where multiple sutures originate from multiple tissue anchors, it may not be possible to orthogonally align the stationary plate 444 with all sutures. In such cases, it is desirable to orthogonally align the stationary plate structure 444 generally in a direction orthogonal to the suture direction (e.g., orthogonal to each of the anchored sutures within 45°).

[0228] Figure 45 A tension balancing device 440 is shown, in which the suture 449 is at least partially unevenly tensioned. Figure 45 In the example shown, suture 449c is tensioned to a greater degree t1 than sutures 449a and 449b. For example... Figure 45 As shown, sutures 449a and 449b may have similar tensions t2 applied thereto, which are less than the tension t1 on suture 449c. The uneven tension t1 on suture 449c can cause tilting of the balancer plate structure 442, which is fixed to suture 449c at suture fixing feature 445c. For example, the balancer plate structure 442 is shown tilted at an angle θ relative to the plane of the substrate structure 444.

[0229] Figure 46 The image shows a tension balancing device 440, in which the balancer plate structure 442 is drawn approximately parallel to the base structure 444. This parallel orientation can be achieved, for example, by adjusting the sutures 449 according to their respective initial tensions. For instance, due to the larger initial tension t1 on suture 449c, the remaining sutures 449a, 449b can be pulled / tightened by a greater distance or amount d1 than the amount d2 pulled / tightened on suture 449c. In some embodiments, suture 449c, initially tensioned to a higher degree, may not be tightened at all, or may even be loosened somewhat. Therefore, it should be understood that the amounts of tension / pulling exemplified in the various figures and described herein may in some cases correspond to negative amounts or values, which can be interpreted as easing the tension on the sutures or otherwise reducing the tension on the sutures.

[0230] Figure 47 A tension balancing device 440 is shown, in which the suture 449 is unevenly tensioned. Figure 47 In the illustrated use case, suture 449c is tensioned to a smaller amount t6 than sutures 449a and 449b, where suture 449a is tensioned to a larger amount t4 than suture 449b (tensioned to an amount t5). The uneven tensions t4, t5, and t6 on sutures 449a, 449b, and 449c can respectively cause tilting of the balancer plate structure 442, which is fixed to suture 449 at corresponding suture fixing features in suture fixing features 445. For example, as shown, the balancer plate 442 can tilt towards suture 449a, while tilting towards suture 449b to a smaller degree.

[0231] Figure 48 The image shows a tension balancing device 440, in which the balancer plate structure 442 is drawn approximately parallel to the base structure 444. For example, this parallel orientation can be determined based on their respective initial tensions (see [link to image]). Figure 47This is achieved by adjusting the seam 449. For example, due to the maximum initial tension t4 on the seam 449, such a seam can be loosened or tightened by a relatively small amount, as indicated by arrow d5. The intermediately tensioned seam 449b can be loosened / tightened to an intermediate amount d4, while the remaining seams 449c can be pulled / tightened by a distance or amount d3 greater than the pulling / tightening amounts d4 and d5 on seams 449a and 449b. In some embodiments, the seam 449a initially tensioned to the highest degree t4 may be left untightened or loosened by a small amount. Furthermore, although the tensioning / pulling of seams to balance tension devices has been described in conjunction with certain examples and aspects of this disclosure, it should be understood that it is possible to loosen over-tightened seams to achieve the desired balance of the panel structure(s).

[0232] Figure 49-1 and Figure 49-2 A flowchart of process 490 for tensioning a suture is shown, based on one or more examples. Figure 50-1 and Figure 50-2 Images corresponding to blocks, states, and / or operations associated with the process of Figure 49 are shown according to one or more examples. Process 490 may be performed at least in part using a parallel plate tension balancing device configured to be attached to a tourniquet to facilitate uniform distribution of suture tension. For example, process 490 may be implemented in conjunction with a mitral valve leaflet repair procedure. Thus, in some embodiments, process 490 may be considered a heart valve repair procedure.

[0233] At box 492, process 490 involves securing the suture to a suture-fixing feature of tension balancing device 510. For example, the tension balancing device may include a stationary plate structure 514, which can be attached to, for example... Figure 50-1 Image 501 shows a tourniquet 511; and a rotating plate 512 having a semi-domed support that engages with the stationary plate. In some embodiments, sutures can be looped and / or compressed onto the stationary and rotating plate structures by means of suture fixation features associated with one or both of the stationary and rotating plate structures. One or more operations associated with box 492 can be performed after the placement of a multi-knot tissue anchor (e.g., on the P2 segment of the posterior mitral valve leaflet), which may be guided by transesophageal echocardiography (TEE).

[0234] At box 494, process 490 involves adjusting the tension of the suture fixed to the suture fixing feature to balance the base plate structure and the balancer plate structure of the tension balancing device so that they are approximately parallel aligned. For example, the suture tension can be adjusted by a surgeon engaging the suture fixing feature to release the suture, after which the suture can be re-fixed to device 510. The adjustment of the suture tension can be performed until the desired alignment is achieved to reduce backflow and / or until the plate structures of the tension balancing device are approximately parallel.

[0235] At box 496, process 490 involves tightening the suture in a certain way under adjusted / balanced tension. For example, pliers or other tools (one or more) can be used to hold / tighten the suture under the desired tension, such as... Figure 50-2 Image 505 is shown. At box 948, process 490 involves removing the tourniquet from the suture. At box 499, process 490 involves anchoring the suture to a tissue wall 521 (e.g., the outer wall of the left ventricle) and / or a pad 522 disposed thereon. For example, this anchoring can be achieved by tying multiple knots 517 with tensioned sutures.

[0236] Other examples

[0237] As can be seen from the examples, certain actions, events, or functions in any process or algorithm described herein can be performed in different orders, added, combined, or omitted entirely. Therefore, in some instances, not all described actions or events are necessary for the practice of the process.

[0238] Unless otherwise specifically stated or understood in the context of use, conditional language used herein, such as “can,” “may,” “possibly,” “may,” “for example,” etc., is intended to have its ordinary meaning and is generally intended to convey that certain instances include certain features, elements, and / or steps, while other instances do not. Therefore, such conditional language is not generally intended to imply that features, elements, and / or steps are required in any one or more instances in any way, or to imply that one or more instances necessarily include the logic used to determine (with or without author input or prompting) whether such features, elements, and / or steps are included or will be performed in any particular instance. The terms “comprise,” “include,” “have,” etc., are synonymous, used in their ordinary meaning, and used inclusively in an open-ended manner without excluding additional elements, features, actions, operations, etc. Furthermore, the term “or” is used in its inclusive meaning (rather than its exclusive meaning), such that when used, for example, in conjunction with an enumeration of elements, the term “or” means one, some, or all of the enumerated elements. Unless otherwise specifically stated, connective language such as the phrase “at least one of X, Y, and Z” should be understood in the context in which it is used to convey that an item, term, element, etc., can be any one of X, Y, or Z. Therefore, such connective language is not usually intended to imply that certain instances require the presence of at least one of X, at least one of Y, and at least one of Z.

[0239] It should be understood that in the above description of the examples, various features are sometimes combined in a single example, drawing, or description thereof to simplify this disclosure and aid in understanding one or more aspects of the invention. However, this method of disclosure should not be construed as reflecting an intention that any claim requires more features than those explicitly recited in that claim. Furthermore, any component, feature, or step exemplified and / or described in the specific examples herein may be applied to or used in conjunction with any other example(s). Moreover, for each example, no component, feature, step, or group of components, features, or steps is necessary or indispensable. Therefore, the scope of this disclosure and the claims is not intended to be limited by the specific examples described above, but should be determined solely by a fair interpretation of the appended claims.

[0240] It should be understood that certain ordinal terms (e.g., “first” or “second”) may be provided for ease of reference and do not necessarily imply physical characteristics or order. Therefore, as used herein, ordinal terms used to modify elements such as structure, component, operation, etc. (e.g., “first,” “second,” “third,” etc.) do not necessarily indicate the priority or order of that element relative to any other element, but rather generally distinguish that element from another element with a similar or identical name (if ordinal terms were not used). Additionally, as used herein, the indefinite article (a (“a” and “an”)) can mean “one or more” rather than “one”. Furthermore, an operation performed “based on” a condition or event can also be performed based on one or more other conditions or events that are not explicitly stated.

[0241] Unless otherwise defined, all terms used herein (including technical and scientific terms) have the same meaning as commonly understood by one of ordinary skill in the art to which the examples pertain. It should be further understood that terms, as defined in commonly used dictionaries, should be interpreted as having a meaning consistent with their meaning in the context of the relevant art, and should not be interpreted in an idealized or overly formal sense unless expressly defined herein.

[0242] The spatially relative terms “outside,” “inside,” “upper,” “lower,” “below,” “above,” “vertical,” “horizontal,” and similar terms may be used herein for ease of description to describe the relationship between one element or component and another element or component exemplified in the accompanying drawings. It should be understood that, in addition to the orientations depicted in the drawings, the spatially relative terms are intended to cover different orientations of the device during use or operation. For example, if the device shown in the drawings is flipped, a device positioned “below another device” or “under another device” may be placed “above another device.” Thus, the exemplary term “below” can include both a lower and upper position. The device may also be oriented in another direction, so the spatially relative terms may be interpreted differently depending on the orientation.

[0243] Unless otherwise explicitly stated, comparative and / or quantitative terms such as “less,” “more,” and “greater” are intended to encompass the concept of equality. For example, “less” can mean not only “less” in the strictest mathematical sense, but also “less than or equal to.”

Claims

1. An assembly comprising a tension distribution device and one or more sutures, the tension distribution device being used to promote uniform distribution of sutures used in conjunction with cardiac lobule tissue anchors, wherein the tension distribution device comprises: A rotationally symmetric structure comprising a base having a top side and a bottom side; One or more circumferential side portions; and Two or more suture joining features associated with the rotationally symmetric structure, the two or more suture joining features corresponding to lateral suture joining features provided in the one or more circumferential side portions; Each of the described suture joining features receives one or more suture portions therein; The one or more suture portions received by one of the suture joining features form a coupling member on the top side of the tension distribution device with the one or more suture portions received by other suture joining features. The two or more suture joining features are evenly spaced apart about the axial center of the rotationally symmetric structure. and The two or more suture joining features are configured to allow the coupling member to migrate on the top side of the tension distribution device toward one or more of the suture joining features in order to adjust the tension of the respective suture portions, and the migration of the coupling member is at least partially caused by the tension difference between the respective suture portions.

2. The assembly according to claim 1, wherein the rotationally symmetric structure is at least partially disk-shaped.

3. The assembly according to claim 1 or claim 2, wherein the top side of the rotationally symmetric structure has one or more suture channels associated therewith.

4. The assembly according to claim 1 or claim 2, wherein the two or more stitched joining features include an opening extending axially from the top side side through the rotationally symmetric structure to the bottom side side.

5. The assembly according to claim 1 or claim 2, wherein the two or more suture joining features comprise four suture joining features.

6. The assembly according to claim 1 or claim 2, wherein the two or more stitch joint features are composed of three stitch joint features.

7. The assembly of claim 6, wherein the rotationally symmetric structure is at least partially triangular in shape.

8. The assembly according to claim 1 or claim 2, further comprising an axial cover.

9. The assembly of claim 8, wherein the cover has a central opening therein.

10. The assembly of claim 8, wherein the cover forms a housing having the rotationally symmetric structure, the housing being configured such that stitching is disposed therein.

11. A method for simulating the uniform distribution of tensioned sutures used in conjunction with cardiac lobule tissue anchors in a simulated patient for whom this is desired, the method comprising: One or more first suture portions are engaged with a first suture engagement feature of a rotationally symmetric tension distribution device structure, the rotationally symmetric tension distribution device structure including a base having a top side and a bottom side and one or more circumferential side portions; One or more second suture portions are engaged with a second suture engagement feature of the rotationally symmetric tension distribution device structure, wherein the first suture engagement feature and the first suture engagement feature correspond to lateral suture engagement features provided in the one or more circumferential side portions; A coupling element between one or more first suture portions and one or more second suture portions is formed on the proximal side of the rotationally symmetric tension distribution device structure, and The tension of the one or more first suture portions and the tension of the one or more second suture portions are adjusted at least in part by allowing the coupling to migrate toward the first suture engagement feature, wherein the migration of the coupling is at least in part caused by the tension difference between the respective suture portions.

12. The method of claim 11, wherein forming the coupling comprises binding the one or more first suture portions together with the one or more second suture portions to form one or more knots.

13. The method of claim 11 or claim 12, wherein the coupling element comprises a clamping device.

14. The method of claim 11 or claim 12, wherein the migration of the coupling member toward the first suture engagement feature balances the tension of the one or more first suture portions and the tension of the one or more second suture portions.

15. The method of claim 11 or claim 12, wherein the adjustment involves reducing the tension of the one or more first suture portions and reducing the tension of the one or more second suture portions.

16. The method of claim 11 or claim 12, wherein the adjustment is performed within the closed thoracic cavity of the simulated patient.

17. The method of claim 11 or claim 12, further comprising pulling slack out from at least one of the one or more first suture portions and the one or more second suture portions prior to forming the coupling.

18. The method of claim 11 or claim 12, wherein the first suture joining feature and the second suture joining feature are positioned: On the common radial axis of the rotationally symmetric tension distribution device structure; and On the opposite side of the rotationally symmetric tension distribution device structure.

19. The method according to claim 11 or claim 12, wherein: The one or more first suture portions are associated with the first implanted tissue anchor; and The one or more second suture portions are associated with the second implanted tissue anchor.

Images