Continuous tethered tissue anchors and related systems and methods

Abstract

The invention relates to a tissue anchor in medical procedures. More specifically, the present invention relates to a tethered anchor. The tether anchor includes a tether portion (108) that is elongated and extends between a first end and a second end, the tether portion being formed from a flat membrane configuration; and an anchoring portion (106) defining a width greater than the width of the tether portion, the anchoring portion being integrally formed with the tether portion of the flat membrane construction and extending continuously from the second end of the tether portion, the anchoring portion having a first aperture (402) through which the tether portion extends.

Description

[0001] This application is a divisional application of application filed on November 8, 2021, with application number 202080034433.2, entitled "Continuous tethered tissue anchors and related systems and methods".

[0002] Cross-reference to related applications

[0003] This application claims priority to Provisional Patent Application No. 62 / 965,595, filed on January 24, 2020, and Provisional Patent Application No. 62 / 845,666, filed on May 9, 2019, the entire contents of which are incorporated herein by reference for all purposes. Background Technology

[0004] Various tissue anchors have been proposed for delivery into the patient. In some examples, such anchors are delivered using percutaneous or transcatheter methods (e.g., using a delivery catheter). Several tissue anchors utilizing swabs and tethering arrangements have also been proposed. For example, such anchors can be used to secure anatomical structures to each other, to attach anatomical structures to an implantable device, or to secure two implantable devices together. Summary of the Invention

[0005] Various examples relate to tissue anchors, methods for forming tissue anchors, and methods related to forming tissue anchors. Various disclosed concepts relate to continuous or integral implantable tissue anchors comprising seamlessly interconnected anchoring and tethering portions. Some examples relate to tethering and anchoring portions formed by membrane structures. In some embodiments, the tethering and anchoring portions are continuously defined as part of a cutting process for holding a tubular member on a mandrel.

[0006] According to one example (“Example 1”), a tethered anchor includes a tethering portion that is elongated and extends between a first end and a second end, the tethering portion being formed of a flat membrane structure, and an anchoring portion that defines a width greater than the width of the tethering portion. The anchoring portion is integrally formed with the flat membrane structure of the tethering portion and extends continuously from the second end of the tethering portion. The anchoring portion has a first orifice through which the tethering portion extends.

[0007] According to another example that goes a step further than Example 1 (“Example 2”), a flat membrane structure comprises multiple layers of membrane material.

[0008] According to another example (“Example 3”) that is a further step of Example 1, the tethered anchor also includes at least one non-transparent marker inserted between multiple layers of membrane material.

[0009] According to another example that goes a step further than Example 1 (“Example 4”), the tethered portion and the anchoring portion have substantially the same thickness where the tethered portion extends from the anchoring portion.

[0010] According to another example (“Example 5”), the tethered anchor is prepared by a process of cutting a preform into a tethered portion and an anchoring portion, the tethered portion extending continuously from the anchoring portion, forming a first orifice in the anchoring portion, and allowing a length of the tethered portion to pass through the first orifice in the anchoring portion.

[0011] According to another example (“Example 6”) that goes further than Example 5, the prefabricated part is cut into a bolting portion and an anchoring portion, including a continuous and integral transition portion defined between the bolting portion and the anchoring portion.

[0012] According to another example (“Example 7”) that further relates to Example 5, cutting the prefabricated part into a bolting portion and an anchoring portion includes forming an anchoring portion having a wider width than the bolting portion.

[0013] According to another example that goes further than Example 5 (“Example 8”), the process also includes forming a plurality of orifices in the anchoring portion and passing the bolting portion through each of the plurality of orifices, such that the anchoring portion defines one or more folds when the bolting portion is tensioned.

[0014] According to another example that goes a step further than Example 5 (“Example 9”), the process also includes forming a preform by wrapping one or more layers of material around a mandrel.

[0015] According to another example that goes further than Example 9 (“Example 10”), the process also includes inserting at least one non-transparent marker between multiple material layers.

[0016] According to another example (“Example 11”), a tethered anchor is formed by cutting a prefabricated part into a tethering portion and an anchoring portion, the tethering portion extending continuously from the anchoring portion, forming a first orifice in the anchoring portion, and allowing a length of the tethering portion to pass through the first orifice in the anchoring portion.

[0017] According to another example (“Example 12”) that goes further than Example 11, the prefabricated part is cut into a bolting portion and an anchoring portion, including a continuous and integral transition portion defined between the bolting portion and the anchoring portion.

[0018] According to another example further than Example 11 (“Example 13”), cutting the prefabricated part into a tethering portion and an anchoring portion includes forming an anchoring portion having a wider width than the tethering portion.

[0019] According to another example further than Example 11 (“Example 14”), the method of forming a tethered anchor also includes forming a plurality of orifices in the anchoring portion and passing the tethered portion through each of the plurality of orifices, such that the anchoring portion defines one or more folds when the tethered portion is tensioned.

[0020] According to another example (“Example 15”) that goes further than Example 11, the method of forming a tethered anchor also includes forming a preform by wrapping one or more layers of material around a mandrel.

[0021] According to another example (“Example 16”) that is a further step of Example 15, the method of forming a tethered anchor also includes inserting at least one non-transparent marker between multiple layers of material.

[0022] According to one example (“Example 17”), a method of treating valvular heart dysfunction includes: disposing a tethered anchor at a target site in a patient, the tethered anchor including: an elongated tethered portion extending between a first end and a second end, the tethered portion being formed of a flat membrane structure; and an anchoring portion defining a width greater than the width of the tethered portion, the anchoring portion being integrally formed with the tethered portion having a flat membrane structure and extending continuously from the second end of the tethered portion, the anchoring portion having a first orifice through which the tethered portion extends.

[0023] According to another example further than Example 17 (“Example 18”), a method of treating heart valve dysfunction includes a tethered anchor configured for chordal repair, replacement or treatment of the defective valve.

[0024] According to one example (“Example 19”), a tethered anchor includes: an elongated tethering portion extending between a first end and a second end, the tethering portion being formed of a flat membrane structure; and an anchoring portion defining a width greater than the width of the tethering portion, the anchoring portion being integrally formed with the flat membrane structure of the tethering portion and extending continuously from the second end of the tethering portion, the anchoring portion having a first orifice through which the tethering portion extends; and at least one needle coupled to the tethering portion.

[0025] According to another example further to Example 19 (“Example 20”), the tethered anchor also includes at least one needle, the at least one needle including a first needle connected to a first end of the tethered portion and a second needle connected to a second end of the tethered portion.

[0026] According to one example (Example “21”), the tethered anchor includes: an elongated tethering portion extending between a first end and a second end, the tethering portion being formed of a flat membrane structure; and an anchoring portion defining a width greater than the width of the tethering portion, the anchoring portion being integrally formed with the flat membrane structure of the tethering portion and extending continuously from the second end of the tethering portion, the anchoring portion having a first orifice through which the tethering portion extends; and at least one tissue anchor connected to the tethering portion.

[0027] According to another example further to Example 21 (“Example 22”), the tethered anchor also includes at least one tissue anchor, the at least one tissue anchor including a first tissue anchor connected to a first end of the tethered portion and a second tissue anchor connected to a second end of the tethered portion.

[0028] The foregoing examples are merely illustrative and should not be construed as limiting or otherwise narrowing the scope of any inventive concept otherwise provided by this disclosure. Although several examples have been disclosed, other examples will become apparent to those skilled in the art from the following detailed description, which illustrates and describes illustrative examples of the invention. Therefore, the drawings and detailed descriptions should be considered illustrative in nature and not restrictive in nature. Attached Figure Description

[0029] The accompanying drawings are provided to give a further understanding of the present disclosure and are included in and form part of this specification, illustrating embodiments and, together with the description, serving to explain the principles of the present disclosure.

[0030] Figure 1 Prefabricated components according to some embodiments are shown;

[0031] Figure 2 Illustrations are shown according to some embodiments Figure 1 The surface of the preform shown;

[0032] Figure 3 A suture with a coiled structure according to some embodiments is shown;

[0033] Figure 4 The continuously formed swab anchor and suture are shown according to some embodiments;

[0034] Figure 5 It shows the partial actuation structure Figure 4 The swab anchor and suture;

[0035] Figure 6 It shows the fully actuated structure Figure 4 and Figure 5 The swab anchor and suture;

[0036] Figure 7 The end portions of the swab anchor and the suture are shown according to some embodiments; and

[0037] Figure 8 The illustration shows a swab anchor and suture used in cord repair surgery according to some embodiments;

[0038] Figure 9 A swab anchor and suture are shown according to some embodiments;

[0039] Figure 9A A swab anchor and suture are shown according to some embodiments;

[0040] Figure 9B A swab anchor and a suture with an interlocking mechanism are shown according to some embodiments;

[0041] Figure 10 It shows the folded structure Figure 11 The swab anchor and suture;

[0042] Figure 11 A pair of swab anchors and sutures connected by an interlocking mechanism according to some embodiments is shown;

[0043] Figure 12 A swab anchor and suture are shown according to some embodiments;

[0044] Figure 13 A swab anchor and suture are shown according to some embodiments;

[0045] Figure 14 The diagram shows a folded configuration according to some embodiments. Figure 15 The swab anchor and suture;

[0046] Figure 15 A swab anchor and suture are shown according to some embodiments;

[0047] Figure 16 The diagram shows a folded configuration according to some embodiments. Figure 17 The swab anchor and suture;

[0048] Figure 17 A swab anchor and suture are shown according to some embodiments;

[0049] Figure 18 A folded structure according to some embodiments is shown. Figure 19 The swab anchor and suture;

[0050] Figure 19 Illustrations are shown according to some embodiments Figure 19The swab anchor and suture;

[0051] Figure 20 A swab anchor with multiple anchoring portions and a suture are shown according to some embodiments;

[0052] Figure 21A A swab anchor with a cylindrical stop member and a suture are shown according to some embodiments;

[0053] Figure 21B A swab anchor with a gasket stop and a suture are shown according to some embodiments;

[0054] Figure 22 The end portions of a swab anchor according to some embodiments and needles disposed at each end are shown;

[0055] Figure 23 An end portion of a swab anchor and a tissue anchor disposed at the end portion are shown according to some embodiments; and

[0056] Figure 24 An end portion of a swab anchor and a tissue anchor disposed at the end portion are shown according to some embodiments.

[0057] Those skilled in the art will readily understand that various aspects of the present invention can be implemented by any number of methods and apparatuses configured to perform the intended functions. It should also be noted that the accompanying drawings referenced herein are not necessarily drawn to scale, but may be enlarged to illustrate various aspects of this disclosure, and in this regard, the drawings should not be construed as limiting. Detailed Implementation

[0058] Definitions and Terms

[0059] This disclosure is not intended to be read in a restrictive manner. For example, the terms used in this application should be read broadly in the context of their meanings that would be attributed to those skilled in the art.

[0060] Regarding imprecise terminology, the terms "about" and "approximately" are used interchangeably to refer to a measurement that includes the stated measurement as well as any measurement that is substantially close to the stated measurement. As will be understood and readily determined by one of ordinary skill in the art, a measurement that is substantially close to the stated measurement deviates from the stated measurement by a relatively small amount. For example, such deviations may be attributable to measurement errors or minor adjustments made to optimize performance.

[0061] As used herein, “joining” means, directly or indirectly, permanently or temporarily, joining, connecting, attaching, adhering, securing, or bonding.

[0062] Description of various embodiments

[0063] Various disclosed concepts involve continuous or integral implantable tissue anchors comprising seamlessly interconnected anchoring and tethering portions. Some examples involve anchors formed continuously from membrane structures (e.g., tubular membrane structures), or swab portions and tethering (tethers), or suture portions.

[0064] As described in further detail below, the implantable anchors discussed in this article can be used in a variety of medical procedures. For example, and in some cases, implantable anchors can be used for filament repair. Furthermore, implantable anchors can be used to treat defective valves (e.g., mitral and tricuspid valves). Implantable anchors can be wrapped around the periphery of the heart or valve annulus to ensure closure of valves experiencing regurgitation. Additionally, implantable anchors can be used in cardiac valve annulus repair or to close openings or orifices formed in the heart wall, such as ventricular or atrial septal defects.

[0065] Figure 1 Preforms 100 are shown cut to form pairs of tethered anchors 102 and 104. The first tethered anchor 102 has an anchoring portion 106 and a tethering portion 108, and the second tethered anchor 104 also has a corresponding anchoring portion 110 and a tethering portion 112. Preforms 100 can be formed by wrapping (wrapping) a film around a mandrel 114 in a spiral (e.g., ribbon wrapping) or tubular (e.g., cigarette wrapping) manner, wherein the mandrel 114 serves as a support structure for the preform 100 during its formation. While wrapping is one method of manufacturing, other methods may be employed as needed, including but not limited to extrusion, molding, stretching, or other processes.

[0066] In some examples, preform 100 is a membrane structure made of a multilayer membrane material (e.g., expanded polytetrafluoroethylene or ePTFE membrane, or related composite material), and preform 100 is formed by placing the multilayer membrane material on top of each other and exposing the layered membrane materials to predetermined pressures and / or temperatures to bond the layers. In one example, a radiopaque marker material is positioned within preform 100, between the membrane material layers, in any desired configuration or type. While mandrel 114 may be tubular with a circular cross-section, in other examples, mandrel 114 has a rectangular, oval, or any other suitable cross-section, including tapered, stepped, or other desired length variations.

[0067] After preform 100 is prepared, it is cut to form one or more tethered anchors, such as tethered anchors 102 and 104. In one example, laser cutting is used, while in another example, other cutting / forming methods may be used, such as waterjet cutting, plasma cutting, or mechanical (blade) cutting. Similarly, although preform 100 is shown as forming... Figure 1 The two tethered anchors are as described above, but other examples may cut the prefabricated part so that one tethered anchor can be formed from a single prefabricated part, or three or more tethered anchors can be formed from that prefabricated part. For simplicity, only the first tethered anchor 102 will be referred to below, but it should be understood that the same explanation and description can be applied to the corresponding part of the second tethered anchor 104.

[0068] Optionally, the prefabricated part 100 can be cut so that the bolted portion 108 has a constant width, such as... Figure 2 As shown, the anchoring portion 106 has a width greater than that of the tethering portion 108. While substantially constant widths are shown for the respective tethering portions 106 and anchoring portions 108, it should be understood that varying widths and non-linear (e.g., curved) cuts are also considered. In any case, the flat membrane-constructed tethering portion 108 is integrally formed with the anchoring portion 106, such that the anchoring portion 106 extends continuously from one end of the tethering portion 108. In one example, the anchoring portion 106 and the tethering portion 108 are formed to have substantially the same thickness because the anchoring portion 106 and the tethering portion 108 are made of the same homogeneous material, and after cutting, the tethering portion 108 can be reshaped from a flat profile to a more rounded profile than the anchoring portion 106. As shown, a smooth, continuous, and integral transition exists between the anchoring portion 106 and the tethering portion 108, which may help reduce wear at the transition between the two portions of the first tethering anchor 102.

[0069] Figure 3 A tethered portion 108 in a coiled or twisted configuration (e.g., after removal from mandrel 114) is shown. The number of turns (coils) or twists per unit length can be adjusted as needed. In some examples, the tethered portion 108 is twisted and compressed by pulling it through a die configured to twist and / or compress it (e.g., in a "candy cane" configuration). The tethered portion 108 may optionally be bonded, sintered, or otherwise formed into a more circular cross-section due to such twisting and compression processes or similar processes. For example, the tethered portion 108 may be tightly coiled in a compressed, twisted configuration such that its cross-section is circular or oval, as... Figure 4 The overall shape is shown in the figure. Although this curling / compaction can change the overall profile and density of the tethered portion 108, the mass of the tethered portion 108 remains unchanged.

[0070] Figure 4 The diagram shows a bolted anchor 102 after the bolted portion 108 has been twisted and compacted to obtain a more circular cross-section, wherein the bolted portion 108 smoothly transitions into the anchoring portion 106, which includes a plurality of intersecting (transverse) orifices 400, such as the first to fifth intersecting (transverse) orifices 402, 404, 406, 408, 410, through which the bolted portion 108 may pass in an alternating, zigzag, or tethered manner, as shown. Figure 5 As shown. The transverse orifice 400 can be pre-formed in the anchoring portion 106 during manufacturing (e.g., the transverse orifice 400 can be laser-cut when the remaining portions of the tethered anchors 102 and 104 are cut), such that only the tethered portion 108 needs to be guided through, extended through, or sequentially disposed therein through one or more transverse orifices 400 to form an arrangement in which the end portion 412 can be tensioned to cause the anchoring portion 106 to collapse, thereby transferring the anchoring portion 106 from the delivery configuration to the anchoring configuration. In some examples, the anchoring portion 106 is formed without any pre-formed transverse orifice or opening, and the transverse orifice is formed after the anchoring portion 106 passes through the surface of the anchoring portion 106 to provide an opening, through which the tethered portion 108 can pass.

[0071] As part of the manufacturing process, or before or during implantation, a needle or other instrument may be used to deliver the end portion 412 through and / or form the transverse orifice 400. The transverse orifice 400 may be equal to, less than, or greater than the thickness of the tethering portion 108. In some examples, the transverse orifice 400 is less than the thickness of the tethering portion 108, but the material of the anchoring portion 106 is expandable or elastic, allowing the tethering portion 108 to pass through the transverse orifice without damaging the tethering portion 108 or the anchoring portion 106. The transverse orifices 400 may be uniformly spaced or have varying spacing. In one example, the transverse orifices 400 are positioned along a relatively straight line, but the transverse orifices 400 may be staggered or otherwise arranged. Moreover, although Figure 4 Five transverse openings are shown, but it should be understood that any suitable number of transverse openings can be used.

[0072] In some examples, the tethering portion defines a proximal segment 414 extending from the end portion 412, a distal segment 418 adjacent to the anchoring portion 106, and an intermediate segment 416 between the proximal segment 414 and the distal segment 418. The proximal segment 414, the intermediate segment 416, and the distal segment 418 may constitute any of a variety of percentages of the length of the tethering portion 108, such as 1 / 3-1 / 3-1 / 3, 90%-10%-10%, or any combination thereof. In some examples, each of segments 414, 416, and 418 constitutes at least 5% of the length of the tethering portion 108.

[0073] Figure 5 An intermediate configuration of the tethered anchor 102 is shown, wherein the end portion 412 is inserted through each transverse through-hole 400 of the anchor portion 106, and the anchor portion 106 is bent or folded to form a plurality of folds 500. In some examples, and as shown, the number of folds 500 formed is the same as the number of transverse through-holes 400 on the anchor portion 106, such as the first to fifth transverse through-holes 402, 404, 406, 408, 410. This configuration is achieved when the end portion 412 is passed through the first transverse through-hole 402, such that the anchor portion 106 is folded between the first transverse through-hole 402 and the second transverse through-hole 404, and the end portion 412 passes through the second transverse through-hole 404. These steps are repeated until the end portion 412 passes through all the transverse through-holes, as shown. Figure 5 As shown, multiple folds 500 are formed in the anchoring portion 106, such as a first fold 502, a second fold 504, a third fold 506, a fourth fold 508, and a fifth fold 510. When viewed from the side, the folds 500 resemble a zigzag or accordion shape. This arrangement allows the anchoring portion 106 to initially present a slender, more linear profile, and then, when the tethering portion 108 is tensioned, the anchoring portion 106 folds downward relative to the longitudinal axis into an expanded transverse profile. In this way, the anchoring portion 106 can initially unfold with a lower profile or delivery configuration (e.g., by insertion through tissue structures) and subsequently be tensioned downward to the expanded profile or anchoring configuration.

[0074] Figure 6 The final product, in an enlarged profile or anchor configuration, is shown after the end portion 412 is pulled away from the anchoring portion 106. As shown, after the bolt portion 108 is tensioned to form the anchor 600, the folds 500 collapse onto each other, having a thickness greater than [missing information]. Figure 4 The thickness of the anchoring portion 106 in its initial form is shown.

[0075] Figure 7An embodiment of the end portion 412 of the first tethering portion 108 as described above is shown. In this embodiment, the end portion 412 has a needle 700 attached (e.g., tied to, adhered to) the end portion 412 such that the needle 700 is implemented as part of the tethering portion 108. In some examples, the needle 700 may be used for skin closure, suturing soft tissue with minimal trauma, or other microsurgical procedures. The needle 700 may have a pointed edge that pierces tissue, and in some examples may also include a cutting blade edge capable of cutting tissue during microsurgical procedures. According to some examples, the needle 700 may have a generally C-shaped, J-shaped, or S-shaped configuration. Furthermore, the needle 700 may be any suitable shape (straight, curved, hooked, bent, twisted, etc. in some examples), size (length less than 3 mm, between 3 mm and 5 mm, between 5 mm and 7 mm, or more than 7 mm in some examples), and material suitable for surgery (nickelinol, stainless steel, or other types of metal in some examples).

[0076] An example of the application of the tethered anchor 102 described herein is chordal repair, such as in the case of chordae tendineae (valve chordae tendineae) of the heart. When a chordae tendineae ruptures and the valve leaflets cannot open and close sufficiently to control blood flow through them, the tethered anchor, as shown herein, can be used to support the opening and closing of the valve leaflets by attaching an anchor portion to the valve leaflet and attaching the other end of the tethered portion to the papillary muscle, forming a prosthetic chordae tendineae. As the papillary muscle contracts, the tethered portion pulls the anchor portion, causing the valve leaflet to open and allowing blood to flow through it. In this example, the anchor portion is attached to the side of the valve leaflet opposite the papillary muscle such that when the papillary muscle contracts, the anchor portion prevents the tethered anchor from being pulled past the orifice through which the tethered portion of the tethered anchor passes.

[0077] Figure 8 An example of this application is shown. In a healthy valve, a set of structures called chordae tendineae 806 connect each leaflet 804 to the papillary muscle 802. However, when the chordae tendineae tear or rupture, the tethered anchor 102, attached to one or more valve leaflets 800, tears its chordae tendineae by first placing or positioning the anchor portion 106 against the distal surface of the valve leaflet 800 relative to the papillary muscle 802. Then, when the tethered portion 108 is tensioned, the anchor portion 106 bends or folds itself to form multiple folds 500, such as... Figure 5 As shown. The tethered portion 108 passes through each transverse orifice 400 in a zigzag pattern, after which the tethered portion 108 is tensioned to completely collapse the folds 500 to form the anchor 600. The end portion 412 of the tethered portion 108 is then attached to the papillary muscle 802, so that movement of the papillary muscle 802 induces movement of the valve leaflet 800.

[0078] Another example of the application of the tethered anchor 102 is in cardiac valve annulusoplasty, where, for example, the ring surrounding the heart valve (valve annulus) is widened and altered from its normal shape. The tethered anchor 102 can be arranged to tighten or reinforce the valve annulus. This prevents blood leakage through the widened valve. Tethered anchors as described herein can be used to keep the annulusoplasty device fixed to the valve annulus and continue to help restore normal valve function.

[0079] Another example use of the tethered anchor 102 is to close openings or orifices formed in the heart wall, such as ventricular or atrial septal defects. The tethered anchor 102 can be used to help close openings inside the heart wall from within the heart, so that blood flow through the heart does not cause the anchor to detach from the wall due to constant pressure applied from inside the heart over time.

[0080] In some examples, echo reflectivity is a factor to consider when implementing tethered anchors so that they can be accurately captured during medical imaging, such as medical ultrasound examinations. For example, if highly echogenic air is incorporated into the material, the material has a stronger echo, and if the material contains a hydrophobic matrix that is immiscible with water, it is better able to capture this highly echogenic air. In one example, the tethered anchor is made of a hydrophobic material and / or coated with a hydrophobic agent to prevent highly echogenic air from escaping into the environment. In another example, the tethered anchor has a radiopaque filler, such as tungsten powder with a small particle size (e.g., less than 1 micrometer), so that the radiopaque filler does not interfere with the function of the tethered anchor but allows it to be visible under fluoroscopy or X-rays.

[0081] Figure 9 and 10 A tethered anchor 900 according to one embodiment is shown, the tethered anchor 900 having a first tethering portion 108 or suture, a second tethering portion 902, and an anchoring portion 106 or swab having a plurality of transverse orifices 400. The anchoring portion 106 has two ends, a first end 904 and a second end 906 opposite to the first end 904. The first tethering portion 108 extends from the first end 904 and the second tethering portion 902 extends from the second end 906, such that when the anchor 600 is formed by passing the first tethering portion 108 through the transverse orifices 400 as previously described, the second tethering portion 902 extends from the anchor 600, as... Figure 10 As shown. In some examples, the second tethering portion 902 can be used to attach additional components to the anchor 600. In some examples, such as Figure 9A As shown, the second tethered portion 902 can extend from the same end (904 or 906) as the first tethered portion 108. Figure 9BAn example of needle 700 is shown, wherein the ends of the first tethering portion 108 and the second tethering portion 902 are interlocked using an interlocking mechanism 908 to form a parachute-like configuration. In some examples, the first needle (not shown) may be attached to the free end of the first tethering portion 108 and the second needle (not shown) may be attached to the free end of the second tethering portion 902, wherein the free end is the unattached end of the tethering portion or the end connected to the anchoring portion 106. These needles can be as explained above and Figure 7 The needle shown is 700. In some examples, the two needles are different from each other, for example, having different shapes, sizes and / or materials.

[0082] Figure 11 and 12 A pair of tethered anchors 102 and 1100 connected to each other via an interlocking mechanism 1104 is shown. The first tethered anchor 102 has a first tethering portion 108 extending from a first anchoring portion 106, while the second tethered anchor 1100 has a second tethering portion 1106 extending from a second anchoring portion 1102. The ends of the two tethering portions 108 and 1106 can be interlocked using the interlocking mechanism 1104, such that the two tethered anchors 102 and 1100 can be used essentially as a single continuous tethered member, having an anchoring element 600 or 1200 at each end, as shown. Figure 12 As shown.

[0083] In this configuration, anchors 600 and 1200 are located on two opposite sides of the two walls 1202 and 1204, and an interlocking mechanism 1104 is disposed in the space between the walls 1202 and 1204, which are separate from the two anchors 600 and 1200. Anchors 600 and 1200 are formed prior to the interlocking of the two bolted portions 108 and 1106. Initially, the first anchor 600 is formed by inserting the bolted portion 108 through the transverse orifice 400 as previously described, and the second anchor 1200 is similarly formed by inserting the second bolted portion 1106 through the transverse orifice 1108 of the second anchored portion 1102. The two free ends of the bolted portions 108 and 1106 are then joined together using the interlocking mechanism 1104.

[0084] In some examples, the interlocking mechanisms 908 and 1104 can be clamps, clips, locking elements, latches, or any suitable mechanism to fasten the two bolted parts 108 and 902 (in... Figure 9B (in) or 1106 (in) Figure 11 and 12(In the middle) they are fixed together. In some examples, the interlocking mechanisms 908 and 1104 also have the ability to adjust the tightening of the tethered members formed by interlocking the two tethered parts 108 and 902 or 1106. For example, a screw or knob may be present on the interlocking mechanism 1104, which, when activated, brings the two anchors 600 and 1200 closer together.

[0085] Figure 13 and 14 An anchoring portion 1300 according to one embodiment is shown, wherein a first row of transverse through holes 1306 are located in a first section 1302 of the anchoring portion 1300, and a second row of transverse through holes 1308 are located in a second section 1304 of the anchoring portion 1300. A fastening portion 108 extends (protrudes) from the anchoring portion 1300 at or between the first section 1302, the second section 1304, and therebetween. The anchoring portion 1300 may be along... Figure 13 The dashed lines indicate a fold. When the anchoring portion 1300 is folded, the first row of transverse through-holes 1306 aligns with the second row of transverse through-holes 1308. After folding the anchoring portion 1300, the bolting portion 108 passes through each of the first and second rows of transverse through-holes 1306, as shown. Figure 14 As shown, the first segment 1302 and the second segment 1304 of the anchoring portion 1300 are oriented to maintain their orientation. Applying a force directed away from the anchoring portion 1300 to the bolted portion 108 causes the folded anchoring portion 1300 to collapse, which is similar to... Figure 2 In the example shown, the anchoring portion 1300 then becomes a folded anchor (not shown).

[0086] Figure 15 and 16 An anchoring portion 1500 according to one embodiment is shown, wherein a first row of transverse through holes 1508 is located in a first segment 1502 of the anchoring portion 1500, a second row of transverse through holes 1510 is located in a second segment 1504 of the anchoring portion 1500, and a third row of transverse through holes 1512 is located on a third segment 1506 of the anchoring portion 1500. Similar to the anchoring portion 1300, the anchoring portion 1500 is foldable along the dotted line, wherein the first, second, and third rows of transverse through holes 1508, 1510, 1512 are stacked on top of each other in the folded configuration, during which the tethering portion 108 can extend from any of the three segments 1502, 1504, 1506 or from between them. Figure 16An anchor portion 1500 is shown folded in a tri-fold or "letter-like" configuration (e.g., similar to how a letter is folded before being placed in an envelope). As previously described, a force is applied to the tethering portion 108 to collapse the folded anchor portion 1500 into a folded anchor (not shown). It should be understood that, depending on the thickness of the anchor portion folded to form the anchor, any other number of segments (e.g., four or more) may be used as appropriate.

[0087] Figures 17 to 19 A cross-shaped anchoring portion 1700 is shown, having five segments or folds 1702, 1704, 1706, 1708, and 1710, and five transverse openings 1703, 1705, 1707, 1709, and 1711 located at or near the center of each segment. In some examples, each fold 1702, 1704, 1706, 1708, and 1710 may be approximately square in shape, wherein each side of the outer periphery of the cross-shaped anchoring portion 1700 is equal or similar in length. A tethering portion 108 may extend from any of the five folds 1702, 1704, 1706, 1708, and 1710. Figure 18 This shows how the anchoring part 1700 can move along... Figure 17 The example shown is a folded dashed line, while Figure 19 An anchoring portion 1700 is shown, which is created by folding the anchoring portion 1700 and passing the bolted portion 108 through transverse through-holes 1703, 1705, 1707, 1709, and 1711 aligned with each other in the folded structure. Figures 13 to 19 The advantages of increasing the number of foldable elements shown include the ability to adjust the anchor thickness resulting from folding (one or more) anchor portions and allowing the tether to pass through them. In some examples, the increased thickness can also increase the stability and durability of the anchor.

[0088] Figure 20 A tethered anchor 2000 according to another embodiment is shown, which includes a plurality of anchoring portions 2002, 2004, 2006 and 2008. Although Figure 20 Four anchoring portions are shown, but any suitable number of anchoring portions can be implemented in other examples. Each pair of adjacent anchoring portions is connected to a connecting member, such that anchoring portions 2002 and 2004 are connected to connecting member 2003, anchoring portions 2004 and 2006 are connected to connecting member 2005, and anchoring portions 2006 and 2008 are connected to connecting member 2007. Similar to the previously mentioned embodiments, anchoring portions 2002, 2004, 2006, and 2008 are folded over each other to form a configuration similar to... Figure 6 The anchoring component 600 in the middle.

[0089] Figure 21A and 21B Two configurations are shown, one for connecting the bolted portion 108 to a stop member that prevents the bolted portion 108 from passing through the anchoring portion 106 or through a transverse through-hole 400 located in the anchoring portion 106. Figure 21A In this configuration, the stop member 2100 can be attached to the bolted portion 108 or at the junction between the anchoring portion 106 and the bolted portion 108. The stop member 2100 can be in the form of a knot, forged structure, coiled structure, or any other suitable structure that restricts the ability of the bolted portion 108 to pass through the anchoring portion 106 or the transverse orifice 400. For example, at least a portion of the stop member 2100 may have a diameter wider than the transverse orifice 400. Figure 21B In this configuration, a forged stop 2102 with a T-shaped cross-section can be connected to the bolted portion 108. The stop 2100 and the forged stop 2102 can have any suitable shape and cross-section and be made of any suitable material, such as metal, rubber, silicone, and other elastic or plastic polymers.

[0090] Figure 22 An end portion of a tethered anchor 102 according to some embodiments is shown, and a needle 700 disposed at each end. As shown, each end portion 412 of the tethered anchor 102 includes a needle 700 coupled to the end portion 412 of the tethering portion 108 of the tethered anchor 102. As described in detail above, the tethering portion 108 may be attached to or coupled to a distal portion 418 of the tethering portion 108. The two-needle tethered anchor 102 can be used in a variety of surgeries, such as skin closure, suturing soft tissue with minimal trauma, or other microsurgical procedures, heart valve repair, or other similar surgeries. In some cases, one or both of the needles may be used as described in the references. Figure 23-24 The organization anchors shown and described are used instead.

[0091] Figure 23 An end portion of a tethered anchor 102 and a tissue anchor 1210 disposed at the end portion are shown according to some embodiments. As shown, the tissue anchor 1210 is coupled to the end portion 412 of the tethered anchor 102. The tissue anchor 1210 can be coupled to the end portion 412 of the tethered portion 108 such that the tissue anchor 1210 is implemented in the end portion 412 as part of the tethered anchor 102. In some cases, the tissue anchor 1210 is attached or adhered to the end portion 412. Figure 22 As shown, tissue anchors 1210 can be connected to both ends of tethered anchors 102. Alternatively, one or more tissue anchors 1210 can be arranged together with both ends of tethered anchors 102 or along tethered anchors 102.

[0092] like Figure 23 As shown, the tissue anchor 1210 includes a helical shape. As illustrated, the tissue anchor 1210 may have one or more coils. The number of turns or loops of the tissue anchor 1210 can be varied to increase or decrease the depth at which the tissue anchor 1210 can be positioned within the leaflet or tissue. The tissue anchor 1210 may be attached to one or both ends of the tethering portion 108, as referenced above. Figure 22 It was discussed in detail.

[0093] Figure 24 An end portion of a tethered anchor 102 and a tissue anchor 1320 disposed at the end portion are shown according to some embodiments. As shown, the tissue anchor 1320 is coupled to the end portion 412 of the tethered anchor 102. The tissue anchor 1320 may be inserted into or adhered to the end portion 412 of the tethered portion 108, such that the tissue anchor 1320 is implemented in the end portion 412 as part of the tethered anchor 102. Figure 22 As shown, the tissue anchor 1320 can be connected to both ends of the tethered anchor 102.

[0094] like Figure 24 As shown, the tissue anchor 1320 includes a plurality of barbs configured to embed within the tissue. The tissue anchor 1320 may include three, four, five, six, or any additional number of barbs to facilitate anchoring within the tissue. The tissue anchor 1320 may be attached to one or both ends of the tethering portion 108, as referenced above. Figure 22 This will be discussed in detail. Additionally, one or more tissue anchors 1320 may be arranged together with both ends of the tethered anchor 100 or along the tethered anchor 100.

[0095] According to various examples, the materials for anchor bolts may include fluoropolymers, including but not limited to polytetrafluoroethylene (PTFE) and / or expanded polytetrafluoroethylene (ePTFE), nylon, polypropylene, polyester, PVDF, filament, or other similar materials. In some examples, the anchor bolts include a diaphragm such as ePTFE, which is combined with an elastomeric or elastomer material such as a fluoropolymer to form a composite material, as disclosed herein. It should be understood that although various examples have been discussed with respect to anchor bolts, the various examples and embodiments discussed herein can be generally applied to each of the anchor bolts discussed herein and / or various components of the anchor bolts.

[0096] Various features associated with some examples and not with others have been specifically described. However, this is not intended to exclude combinations of features between the examples. Rather, such combinations are specifically considered and form part of this disclosure. The inventive concept of this disclosure has been described generally and with reference to specific embodiments. It will be apparent to those skilled in the art that various modifications and alterations can be made to the embodiments without departing from the scope of this disclosure. Therefore, the embodiments are intended to cover modifications and alterations of the invention, provided they fall within the scope of the appended claims and their equivalents.

Claims

1. A bolted anchor, comprising: The tethered portion is elongated and extends between a first end and a second end of the tethered portion, and the tethered portion is formed of a flat membrane structure; as well as An anchoring portion, the width of which is greater than the width of the tethering portion, the anchoring portion being integrally formed with the tethering portion, the anchoring portion having a first orifice, the tethering portion extending through the first orifice, and the anchoring portion defining a fold.

2. The bolted anchoring element according to claim 1, characterized in that, The anchoring portion includes a second opening, wherein when the anchoring portion is folded, the first opening and the second opening are aligned.

3. The bolted anchoring element according to claim 2, characterized in that, The anchoring portion defines a first row of holes including the first orifice and a second row of holes including the second orifice, wherein when the anchoring portion is folded, the first row of holes and the second row of holes are aligned.

4. The bolted anchoring component according to claim 2, characterized in that, The anchoring portion includes a first segment and a second segment, wherein a first orifice is defined in the first segment, a second orifice is defined in the second segment, and wherein when the anchoring portion is folded, the tethering portion passes through the first orifice and the second orifice to maintain the orientation of the first segment and the second segment of the anchoring portion.

5. The bolted anchoring element according to claim 2, characterized in that, The anchoring portion includes a third opening, wherein when the anchoring portion is folded, the first opening, the second opening, and the third opening are aligned.

6. The bolted anchoring element according to claim 5, characterized in that, The anchoring portion defines a first row of holes including the first hole, a second row of holes including the second hole, and a third row of holes including the third hole, wherein when the anchoring portion is folded, the first row of holes, the second row of holes, and the third row of holes are aligned.

7. The bolted anchoring element according to claim 6, characterized in that, The anchoring portion includes a first section, a second section, and a third section, wherein a first row of orifices is defined in the first section, a second row of orifices is defined in the second section, and a third row of orifices is defined in the third section, and wherein when the anchoring portion is folded, the tethering portion passes through the first row of orifices, the second row of orifices, and the third row of orifices to maintain the orientation of the first and second sections of the anchoring portion.

8. The bolted anchoring element according to claim 7, characterized in that, The folded portion includes a first folded portion defined between the first segment and the second segment, and a second folded portion defined between the first segment and the third segment.

9. The bolted anchoring element according to claim 8, characterized in that, The anchoring portion is defined by a three-fold structure.

10. The bolted anchoring element according to claim 1, characterized in that, The anchoring portion includes a first section, a second section, a third section, a fourth section, and a fifth section, wherein each section defines an opening.

11. The bolted anchoring element according to claim 10, characterized in that, The first segment, the second segment, the third segment, the fourth segment, and the fifth segment define a cross shape.

12. The bolted anchoring element according to claim 11, characterized in that, The first segment is located at the center of the cross shape.

13. The bolted anchoring element according to claim 12, characterized in that, A fold is defined at each edge of the first segment.

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