Continuous tethered tissue anchors and related systems and methods

Abstract

To provide good tether anchors, etc. [Solution] The present invention relates to a tissue anchor in medical procedures. More specifically, the present invention relates to a tether anchor. The tether anchor includes a tether portion (108) which is elongated and extends between a first end and a second end, wherein the tether portion is formed from a flat film structure, and an anchor portion (106) which defines a width greater than the width of the tether portion, wherein the anchor portion is formed integrally with the tether portion from a flat film structure and extends continuously from the second end of the tether portion, and the anchor portion has a first aperture (402) through which the tether portion extends.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of Provisional Application No. 62 / 965,595, filed Jan. 24, 2020, and also claims the benefit of Provisional Application No. 62 / 845,666, filed May 9, 2019, and both are incorporated herein by reference in their entirety for all purposes.

Background Art

[0002] Background For delivery into a patient's body, various tissue anchors have been proposed. In some instances, such anchors are delivered using a percutaneous or trans - catheter approach (e.g., using a delivery catheter). Some tissue anchors utilize the placement of cotton tufts and tethers. Such anchors can be used, for example, to fix anatomical structures to each other, to fix anatomical structures to an implanted device, or to fix two implanted devices together.

Summary of the Invention

[0003] Summary Various examples relate to tissue anchors, methods used to form tissue anchors, and related methods of forming tissue anchors. Various disclosed concepts relate to continuous or integral implantable tissue anchors that include seamlessly interconnected anchor portions and tether portions. Some examples relate to tether and anchor portions formed from a film structure. In some embodiments, the tether and anchor portions are continuously identified as part of a cutting procedure for a tubular member maintained on a mandrel.

[0004] According to one example ("Example 1"), a tethered anchor includes a tethered portion that is elongated and extends between a first end and a second end, wherein the tethered portion is formed from a flat film structure, and an anchor portion that defines a width greater than the width of the tethered portion. The anchor portion is integrally formed with the tethered portion of the flat film structure and extends continuously from the second end of the tethered portion. The anchor portion has a first aperture through which the tethered portion extends.

[0005] In addition to Example 1, another example ("Example 2") shows that the flat film structure includes multiple layers of film material.

[0006] In addition to Example 1, another example ("Example 3") further includes at least one radiopaque marker inserted between multiple layers of the film material.

[0007] In addition to Example 1, another example ("Example 4") shows that the tether portion and the anchor portion have substantially the same thickness, and the tether portion extends from the anchor portion.

[0008] In another example ("Example 5"), a tethered anchor is prepared by cutting a preform into a tethered portion and an anchor portion, wherein the tethered portion extends continuously from the anchor portion, a first aperture is formed in the anchor portion, and a certain length of the tethered portion is passed through the first aperture in the anchor portion.

[0009] In addition to Example 5, another example ("Example 6") shows that cutting the preform into tether and anchor portions includes defining a continuous and integrated transition between the tether portion and the anchor.

[0010] In addition to Example 5, another example ("Example 7") shows that cutting the preform into tether and anchor portions includes forming an anchor portion that is wider than the tether portion.

[0011] In addition to Example 5, another example ("Example 8") further comprises forming a plurality of apertures in the anchor portion and passing the tether portion through each of the plurality of apertures, so that the anchor portion defines one or more pleats when tension is applied to the tether portion.

[0012] In addition to Example 5, another example ("Example 9") further includes forming a preform by winding one or more layers of material onto a mandrel.

[0013] In addition to Example 9, another example ("Example 10") further includes inserting at least one radiopaque marker between layers of material.

[0014] In another example ("Example 11"), the tethered anchor is formed by cutting a preform into a tethered portion and an anchor portion, wherein the tethered portion extends continuously from the anchor portion, a first aperture is formed in the anchor portion, and a certain length of the tethered portion passes through the first aperture of the anchor portion.

[0015] In addition to Example 11, another example ("Example 12") shows that cutting the preform into tether and anchor portions includes defining a continuous and integrated transition between the tether portion and the anchor.

[0016] In addition to Example 11, another example ("Example 13") shows that cutting the preform into tether and anchor portions includes forming an anchor portion that is wider than the tether portion.

[0017] In addition to Example 11, another example ("Example 14") further includes forming a tether anchor in the anchor portion and passing the tether portion through each of the apertures, so that when tension is applied to the tether portion, the anchor portion defines one or more pleats.

[0018] In addition to Example 11, another example ("Example 15") shows that the method for forming the tether anchor further includes forming a preform by winding one or more layers of material onto a mandrel.

[0019] In addition to Example 15, another example ("Example 16") further includes inserting at least one radiopaque marker between layers of material.

[0020] According to one example ("Example 17"), a method for treating cardiac valve insufficiency comprises positioning a tether anchor at a target location in a patient, the tether anchor comprising a tether portion which is elongated and extends between a first end and a second end, wherein the tether portion is formed from a flat film structure, and an anchor portion which defines a width greater than the width of the tether portion, wherein the anchor portion is integrally formed with the tether portion of the flat film structure and extends continuously from the second end of the tether portion, the anchor portion having a first aperture through which the tether portion extends.

[0021] In addition to Example 17, another example ("Example 18") describes a method for treating cardiac valve insufficiency that includes a tether anchor configured for repairing or replacing cord-like tissue or for treating a defective valve.

[0022] According to one example ("Example 19"), the tether anchor is elongated and includes a tether portion extending between a first end and a second end, wherein the tether portion is formed from a flat film structure, and an anchor portion defining a width greater than the width of the tether portion, wherein the anchor portion is integrally formed with the tether portion of the flat film structure and extends continuously from the second end of the tether portion, the anchor portion having a first aperture through which the tether portion extends, and at least one needle coupled to the tether portion.

[0023] In addition to Example 19, according to another example ("Example 20"), the tether anchor also includes at least one needle, the at least one needle including a first needle coupled to a first end of the tether portion and a second needle coupled to a second end of the tether portion.

[0024] According to one example ("Example 21"), the tether anchor includes a tether portion that is elongated and extends between a first end and a second end, wherein the tether portion is formed from a flat film structure, and an anchor portion that defines a width greater than the width of the tether portion, wherein the anchor portion is integrally formed with the tether portion of the flat film structure and extends continuously from the second end of the tether portion, the anchor portion having a first aperture through which the tether portion extends, and at least one tissue anchor coupled to the tether portion.

[0025] In addition to Example 21, according to another example ("Example 22"), the tether anchor also includes at least one tissue anchor, which includes a first tissue anchor coupled to a first end of the tether portion and a second tissue anchor coupled to a second end of the tether portion.

[0026] The above examples are exactly examples and should not be read as limiting or otherwise narrowing the scope of any of the concepts of the invention provided by other means according to the present disclosure. Although multiple examples are disclosed, further embodiments will become apparent to those skilled in the art from the following detailed description which illustrates the exemplary examples. Therefore, the drawings and the detailed description should be considered to be essentially illustrative rather than essentially limiting.

Brief Description of the Drawings

[0027] Brief Description of the Drawings The accompanying drawings are included to provide a further understanding of the present disclosure, are incorporated herein, form a part thereof, show embodiments, and together with the description serve to explain the principles of the present disclosure.

[0028] [Figure 1] FIG. 1 shows a preform according to some embodiments.

[0029] [Figure 2] FIG. 2 shows the surface of the preform shown in FIG. 1 according to some embodiments.

[0030] [Figure 3] FIG. 3 shows a suture in a rounded configuration according to some embodiments.

[0031] [Figure 4] FIG. 4 shows a continuously formed cotton fluff anchor and suture according to some embodiments.

[0032] [Figure 5] FIG. 5 shows the cotton fluff anchor and suture of FIG. 4 in a partially actuated configuration.

[0033] [Figure 6] FIG. 6 shows the cotton fluff anchor and suture of FIGS. 4 and 5 in a fully actuated configuration.

[0034] [Figure 7] Figure 7 shows the ends of cotton thread anchors and sutures according to several embodiments.

[0035] [Figure 8] Figure 8 shows cotton-wrapped anchors and sutures used in cord-like tissue repair procedures according to several embodiments.

[0036] [Figure 9] Figure 9 shows cotton thread anchors and sutures according to several embodiments.

[0037] [Figure 9A] Figure 9A shows cotton thread anchors and sutures according to several embodiments.

[0038] [Figure 9B] Figure 9B shows cotton thread anchors and sutures with interlocking mechanisms according to several embodiments.

[0039] [Figure 10] Figure 10 shows the cotton thread anchor and sutures of Figure 11 in a folded configuration.

[0040] [Figure 11] Figure 11 shows a pair of cotton thread anchors and sutures connected by an interlocking mechanism, according to several embodiments.

[0041] [Figure 12] Figure 12 shows cotton thread anchors and sutures according to several embodiments.

[0042] [Figure 13] Figure 13 shows cotton thread anchors and sutures according to several embodiments.

[0043] [Figure 14] Figure 14 shows the cotton thread anchor and sutures of Figure 15 in a folded configuration according to several embodiments.

[0044] [Figure 15] Figure 15 shows cotton thread anchors and sutures according to several embodiments.

[0045] [Figure 16] Figure 16 shows the cotton thread anchor and sutures of Figure 17 in a folded configuration according to several embodiments.

[0046] [Figure 17] Figure 17 shows cotton thread anchors and sutures according to several embodiments.

[0047] [Figure 18] Figure 18 shows the folded cotton thread anchor and sutures of Figure 19 in several embodiments.

[0048] [Figure 19] Figure 19 shows the cotton thread anchor and suture of Figure 19 according to several embodiments.

[0049] [Figure 20] Figure 20 shows cotton thread anchors and sutures with multiple anchor portions according to several embodiments.

[0050] [Figure 21A] Figure 21A shows cotton thread anchors and sutures with tubular stop components according to several embodiments.

[0051] [Figure 21B] Figure 21B shows cotton thread anchors and sutures equipped with washer stoppers according to several embodiments.

[0052] [Figure 22] Figure 22 shows cotton thread anchors and needle ends positioned at each end according to several embodiments.

[0053] [Figure 23] Figure 23 shows the ends of cotton yarn anchors and tissue anchors positioned at the ends according to several embodiments.

[0054] [Figure 24] Figure 24 shows the ends of cotton yarn anchors and tissue anchors positioned at the ends according to several embodiments.

[0055] Those skilled in the art will readily understand that various aspects of this disclosure can be realized by any number of methods and apparatus configured to perform the intended functions. It should also be noted that the accompanying drawings referenced herein are not necessarily drawn to a fixed scale and may be exaggerated to illustrate various aspects of this disclosure; in this regard, the drawings should not be construed as limiting. [Modes for carrying out the invention]

[0056] Detailed explanation Definitions and Terms 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 relation to the semantic relationships to which the terms in the art belong.

[0057] With regard to the term inaccuracy, “approximately” and “nearly” are interchangeable and used to refer to a measurement, which may include the stated measurement and may also include a measurement that is reasonably close to the stated measurement. A measurement that is reasonably close to the stated measurement deviates by a reasonably small amount from the stated measurement, as can be understood and readily confirmed by those skilled in the art. Such deviations may be due, for example, to measurement errors or fine-tuning made to optimize performance.

[0058] As used herein, “couple” means to join, connect, attach, adhere, paste, or bond, whether directly or indirectly, and whether permanent or temporary.

[0059] Description of various embodiments The various disclosures relate to continuous or integrated implantable tissue anchors, including seamlessly interconnected anchor and tether portions. Some examples relate to anchor or cotton-wrapped portions and tether or suture portions formed continuously from a film structure (e.g., a tubular film structure).

[0060] As will be described in more detail below, the implantable anchors discussed herein can be used in a variety of medical procedures. For example, in certain cases, implantable anchors can be used in ligamentous tissue repair. Furthermore, implantable anchors can be used to treat defective valves (e.g., mitral valve, tricuspid valve). Implantable anchors can be wrapped around the heart or valve annulus to ensure closure of a valve experiencing regurgitation. In addition, implantable anchors can be used in cardiac annuloplasty procedures or when closing openings or apertures formed in the heart wall, such as ventricular or atrial septal defects.

[0061] Figure 1 shows a preform 100 cut to form a pair of tether anchors 102 and 104. The first tether anchor 102 has an anchor portion 106 and a tether portion 108, and the second tether anchor 104 also has a corresponding anchor portion 110 and a tether portion 112. The preform 100 can be formed by winding a film around a mandrel 114 in a helical pattern (e.g., tape winding) or a tubular pattern (e.g., cigarette winding), with the mandrel 114 acting as a support structure for the preform 100 during its formation. Winding is one means of manufacture, but others may be used as needed, but are not limited to, extrusion, molding, stretching, or other processes.

[0062] In some examples, the preform 100 is a film structure made of multiple layers of film material (e.g., stretched polytetrafluoroethylene or ePTFE film or related composite material), which is formed by arranging multiple layers of film material on each other and exposing the layered film material to a predetermined pressure and / or temperature to bond the layers. In one example, a radiopaque marker material is placed within the preform 100 between the layers of film material in any desired configuration or pattern. The mandrel 114 may be tubular and have a circular cross-section, and in other examples, the mandrel 114 may have a rectangular, oval, or other suitable cross-section, which may include tapers, steps, or other longitudinal changes as needed.

[0063] After the preform 100 is prepared, it is cut to form one or more tether anchors, such as tether anchors 102 and 104. In one example, the cutting is performed using a laser, but in another example, other cutting / forming methods such as waterjet cutting, plasma cutting, or mechanical (blade) cutting can be used. Also, although the preform 100 is shown in Figure 1 to form two tether anchors, in other examples the preform can be cut so that one tether anchor can be formed from a single preform, or so that three or more tether anchors can be formed from the preform. For simplicity and to proceed, only the first tether anchor 102 is mentioned, but it should be understood that the same description and details may apply to each part of the second tether anchor 104.

[0064] The preform 100 is cut, in some cases, as shown in Figure 2, such that the tether portion 108 has a constant width and the anchor portion 106 has a width greater than that of the tether portion 108. Although substantially constant widths are shown for each tether portion and anchor portion 106, 108, it should be understood that cuts with varying widths and non-linear (e.g., winding) cuts are also possible. In any case, the anchor portion 106 is formed integrally with the tether portion 108 of the flat film structure such that the anchor portion 106 extends continuously from one end of the tether portion 108. In one example, the anchor portion 106 and the tether portion 108 have substantially the same thickness as formed, since the anchor portion 106 and the tether portion 108 are formed from the same homogeneous material. Following the cutting, the tether portion 108 may be reshaped from the flat profile to have a rounder profile than the anchor portion 106. As shown, there is a smooth, continuous, and integrated transition between the anchor portion 106 and the tether portion 108, which can help reduce wear at the transition between the two portions of the first tether anchor 102.

[0065] Figure 3 shows the tether portion 108 in a curled or twisted configuration (e.g., after being removed from the mandrel 114). The number of turns or twists per unit length can be adjusted as desired. In some examples, the tether portion 108 is twisted and compressed by pulling it through a die configured to twist and / or compress it (e.g., a "candy cane" configuration). The tether portion 108 may be processed to have a more circular cross-section by bonding, sintering, or other methods, such as through this twisting and compression process. For example, the tether portion 108 can be tightly curled in a compressed, twisted configuration such that its cross-section is circular or oval, as is commonly shown in Figure 4. This curling / compression may alter the overall profile of the tether portion 108, as well as its density, but the mass of the tether portion 108 remains unchanged.

[0066] Figure 4 shows the tether anchor 102 after the tether portion 108 has been twisted and compressed to achieve a more circular cross section, and the tether portion 108 smoothly transitions into the anchor portion 106 which includes multiple crossing apertures 400 such as the first to fifth crossing apertures 402, 404, 406, 408, 410, and the tether portion 108 can pass through the crossing apertures in alternating, zigzag, or tethering patterns, as shown in Figure 5. The cross aperture 400 can be pre-formed into the anchor portion 106 during manufacturing (for example, the cross aperture 400 can be laser-cut when the rest of the tether anchors 102 and 104 are cut), so that only the tether portion 108 needs to be guided through the cross aperture 400, extend through it, or be sequentially positioned within it, creating an arrangement in which tension can be applied so that the end 412 collapses the anchor portion 106 and moves the anchor portion 106 from the delivery configuration to the anchor configuration. In some examples, the anchor portion 106 is formed without pre-forming the cross aperture or opening, and the cross aperture is formed after the anchor portion 106 is formed by perforating the surface of the anchor portion 106, providing an opening through which the tether portion 108 can pass.

[0067] As part of the manufacturing process, or before or during implantation, the end portion 412 can be delivered through the cross aperture 400 and / or the cross aperture 400 can be formed using a needle or other instrument. The size of the cross aperture 400 can be the same as, smaller than, or larger than the thickness of the tether portion 108. In some examples, the cross aperture 400 is smaller than the thickness of the tether portion 108, but the material of the anchor portion 106 is expandable or elastic, so that the tether portion 108 can pass through the cross aperture without damaging either the tether portion 108 or the anchor portion 106. The cross apertures 400 can be spaced equally or with varying spacing. In one example, the cross apertures 400 are arranged in a relatively straight line, but the cross apertures 400 may be staggered or arranged in other ways. And although Figure 4 shows five cross apertures, it is understood that any appropriate number of cross apertures can be used.

[0068] In some examples, the tether portion defines a distal section 418 adjacent to the anchor portion 106 from the end 412, and a proximal section 414 extending to an intermediate section 416 between the proximal section 414 and the distal section 418. The proximal section 414, the intermediate section 416, and the distal section 418 can constitute any of several percentages of the length of the tether portion 108, such as 1 / 3-1 / 3-1 / 3, 90%-10%-10%, or various combinations. In some examples, each of sections 414, 416, and 418 constitutes at least 5% of the length of the tether portion 108.

[0069] Figure 5 shows an intermediate configuration of a tethered anchor 102, in which the end portion 412 is inserted through each of the crossing apertures 400 of the anchor portion 106, causing the anchor portion 106 to be bent or folded to form a number of pleats 500. In some examples, as shown, the number of pleats 500 formed is the same as the number of crossing apertures 400 on the anchor portion 106, such as the first to fifth crossing apertures 402, 404, 406, 408, 410, etc. This configuration is achieved when the end portion 412 is passed through the first crossing aperture 402, resulting in the anchor portion 106 being folded between the first crossing aperture 402 and the second crossing aperture 404, with the end portion 412 passing through the second crossing aperture 404. These steps are repeated until the end 412 passes through all the intersecting apertures, as shown in Figure 5, forming multiple pleats 500 within the anchor portion 106, such as a first pleat 502, a second pleat 504, a third pleat 506, a fourth pleat 508, and a fifth pleat 510. The pleats 500 resemble a zigzag or accordion shape when viewed from the side. This configuration allows the anchor portion 106 to initially take on a long, more linear profile, and then, when tension is applied to the tether portion 108, the anchor portion 106 folds into a transverse profile that is expanded relative to the longitudinal axis. In this way, the anchor portion 106 is first unfolded in a lower profile or delivery configuration (e.g., by being inserted through the tissue structure), and then tension is applied to the expanded profile or anchor configuration.

[0070] Figure 6 shows the enlarged profile or final product of the anchor configuration after the end portion 412 has been pulled away from the anchor portion 106. As shown, the pleats 500 collapse from each other after tension is applied to the tether portion 108 to form an anchor 600 that is thicker than the initial form of anchor portion 106 shown in Figure 4.

[0071] Figure 7 shows one embodiment of the end 412 of the first tether portion 108, as described above. In this embodiment, the end 412 has a needle 700 coupled to (e.g., tied and bonded to) the end 412 so that the needle 700 is implemented as part of the tether portion 108. In some examples, the needle 700 may be used for skin closure, soft tissue suturing with minimal trauma, or other microsurgical procedures. The needle 700 may have a pointed end that penetrates tissue, and in some examples may also include a cutting blade edge that can cut open tissue during microsurgical procedures. According to some examples, the needle 700 may generally have a C-shaped, J-shaped, or S-shaped configuration. Furthermore, the needle 700 can be any suitable shape (in some cases, straight, curved, hooked, bent, twisted, etc.), size (in some cases, shorter than 3 mm, 3 mm to 5 mm, 5 mm to 7 mm, or longer than 7 mm), and material suitable for surgical procedures (in some cases, nitinol, stainless steel, or other types of metal).

[0072] One example of the application of the tether anchor 102 as described herein is in the repair of cord-like tissues, such as those of the valvular tissue of the heart. When the valvular tissue is damaged and the valve leaflets cannot open and close sufficiently to control blood flow through them, the tether anchor as shown herein can be used to support the opening and closing of the valve leaflets by attaching the anchor portion to the valve leaflet and connecting the other end of the tether portion to the papillary muscle, thereby creating an artificial valve cord. When the papillary muscle contracts, the tether portion pulls the anchor portion, opening the valve leaflet and allowing blood flow through it. In this example, since the anchor portion is attached to the side of the valve leaflet opposite to the papillary muscle, when the papillary muscle contracts, the anchor portion prevents the tether anchor from being pulled through the aperture through which the tether portion of the tether anchor passes.

[0073] Figure 8 shows one example of this application. In a healthy valve, a set of structures called chordae tendineae 806 connects each valve leaflet 804 to the papillary muscle 802. However, when the chordae tendineae are torn or destroyed, the tether anchor 102 is attached to one or more valve leaflets 800 where the chordae tendineae are torn, by first setting or positioning the anchor portion 106 on the distal surface of the valve leaflet 800 relative to the papillary muscle 802. Next, as shown in Figure 5, tension is applied to the tether portion 108, causing the anchor portion 106 to bend or fold over itself to form a series of pleats 500. The tether portion 108 passes through each of the intersecting apertures 400 in a zigzag pattern, and then tension is applied to the tether portion 108 so that the pleats 500 completely collapse to form an anchor 600. The end 412 of the tether portion 108 is subsequently attached to the papillary muscle 802, so that the movement of the papillary muscle 802 induces the movement of the valve leaflet 800.

[0074] Another example of the application of the tether anchor 102 is, for example, cardiac annuloplasty, in which the ring (annulus) around a heart valve widens and changes from its normal shape. The tether anchor 102 can be positioned to tighten or reinforce the annulus of the valve. This can prevent blood leakage from the widened valve. The tether anchor as described herein can be used to keep the annuloplasty device fixed to the annulus and continue to assist in the restoration of the valve's normal function.

[0075] Another use case for the tether anchor 102 is to close openings or apertures formed in the heart wall, such as ventricular or atrial septal defects. The tether anchor 102 is used to help close the opening from inside the heart wall, with constant pressure from within the heart preventing blood flow through the heart from dislodging the anchor from the wall over time.

[0076] In several cases, echogenicity is a factor to consider when implementing tether anchors so that they can be accurately captured during medical imaging such as medical ultrasound. For example, a material is more echogenic when it contains highly echogenic air, and a material can better capture such highly echogenic air if it contains a hydrophobic, water-immiscible matrix. In one example, a tether anchor is made from a hydrophobic material and / or coated with a layer of hydrophobic agent to prevent highly echogenic air from escaping into the environment. In another example, a tether anchor has a radiopaque filler, such as tungsten powder with a small particle size (e.g., less than 1 micron), so that the radiopaque filler does not interfere with the function of the tether anchor, and the tether anchor can be seen under fluorescence or X-ray.

[0077] Figures 9 and 10 show a tethered anchor 900 according to one embodiment, comprising a first tether portion 108 or suture, a second tether portion 902, and an anchor portion 106 or cotton spool, together with a plurality of cross apertures 400. The anchor portion 106 has two ends: a first end 904 and a second end 906 opposite the first end 904. The first tether portion 108 extends from the first end 904, and the second tether portion 902 extends from the second end 906, so that when the anchor 600 is formed by passing the first tether portion 108 through the cross apertures 400 as described above, the second tether portion 902 extends from the anchor 600 as shown in Figure 10. In some examples, the second tether portion 902 can be used to attach additional components to the anchor 600. In some examples, the second tether portion 902 may extend from the same end (904 or 906) as the first tether portion 108, as shown in Figure 9A. Figure 9B shows an example of a needle 700 in which the ends of the first tether portion 108 and the second tether portion 902 are interlocked using an interlock mechanism 908 to form a parachute-like configuration. In some examples, a first needle (not shown) may be attached to the free end of the first tether portion 108, and a second needle (not shown) may be attached to the free end of the second tether portion 902, where the free end is the end of the tether portion that is not attached to or connected to the anchor portion 106. These needles may be needles 700, as described above and shown in Figure 7. In some examples, the two needles may differ from each other, such as having different shapes, sizes and / or materials.

[0078] Figures 11 and 12 show a pair of tether anchors 102 and 1100 connected to each other via an interlock mechanism 1104. The first tether anchor 102 has a first tether portion 108 extending from a first anchor portion 106, and the second tether anchor 1100 has a second tether portion 1106 extending from a second anchor portion 1102. The ends of the two tether portions 108 and 1106 can be interlocked using the interlock mechanism 1104, so that the two tether anchors 102 and 1100 can be essentially used as a single continuous tether with anchors 600 or 1200 at each end, as shown in Figure 12.

[0079] In this case, anchors 600 and 1200 are positioned on two opposing sides of two walls 1202 and 1204, and the interlock mechanism 1104 is positioned in the space between walls 1202 and 1204 separated from the two anchors 600 and 1200. Anchors 600 and 1200 are formed before the two tether portions 108 and 1106 are interlocked. First, the first anchor 600 is formed by inserting the tether portion 108 through the cross aperture 400 as described above, and the second anchor 1200 is similarly formed by inserting the second tether portion 1106 through the cross aperture 1108 of the second anchor portion 1102. The two free ends of the tether portions 108 and 1106 are then joined together using the interlock mechanism 1104.

[0080] In some examples, the interlocking mechanisms 908 and 1104 can be clamps, clips, locks, latches, or any suitable mechanism for securing the two tether portions 108 and 902 (Figure 9B) or 1106 (Figures 11 and 10). In some examples, the interlocking mechanisms 908 and 1104 also have a tightening capability that allows adjustment of the length of the tether formed by interlocking the two tether portions 108 and 902 or 1106. For example, the interlocking mechanism 1104 may have a screw or knob that, when actuated, brings the two anchors 600 and 1200 closer together.

[0081] Figures 13 and 14 show an anchor portion 1300 according to one embodiment, having a first row of cross apertures 1306 located in a first section 1302 of the anchor portion 1300 and a second row of cross apertures 1308 located in a second section 1304 of the anchor portion 1300. The tether portion 108 extends from the anchor portion 1300 in the first section 1302, the second portion 1304, or between them. The anchor portion 1300 can be folded along the dashed line, as shown in Figure 13. When the anchor portion 1300 is folded, the first row of cross apertures 1306 aligns with the second row of cross apertures 1308. After the anchor portion 1300 is folded, the tether portion 108 intersects with the first and second rows of the crossing aperture 1306, respectively, as shown in Figure 14, to maintain the orientation of the first and second sections 1302 and 1304 of the anchor portion 1300. When force is applied to the tether portion 108 in a direction away from the anchor portion 1300, the folded anchor portion 1300 collapses, as in the example shown in Figure 2, and the anchor portion 1300 subsequently becomes a folded anchor (not shown).

[0082] Figures 15 and 16 show an anchor portion 1500 according to one embodiment, having a first row 1508 of cross apertures located in a first section 1502 of the anchor portion 1500, a second row 1510 of cross apertures located in a second section 1504 of the anchor portion 1500, and a third row 1512 of cross apertures located in a third section 1506 of the anchor portion 1500. Similar to the anchor portion 1300, the anchor portion 1500 is foldable along the dashed lines, where the first, second, and third rows 1508, 1510, and 1512 of cross apertures overlap each other in a folded configuration, with the tether portion 108 extending from any one of the three sections 1502, 1504, and 1506 or between them. Figure 16 shows that the anchor portion 1500 is folded in a tri-fold or "letterfold" configuration (similar to how a letter is folded before being placed inside an envelope). When force is applied to the tether portion 108 as described above, the folded anchor portion 1500 collapses into a folded anchor (not shown). It should be understood that any other number of sections (e.g., four or more) can be used as appropriate, depending on the thickness of the anchor portion that is folded to form the anchor.

[0083] Figures 17–19 show a cruciform anchor section 1700 having five sections or pleats 1702, 1704, 1706, 1708, 1710 and five intersecting apertures 1703, 1705, 1707, 1709, 1711, each positioned at or near the center of the respective section. In some examples, each pleat 1702, 1704, 1706, 1708, 1710 can be substantially square in shape, and each side of the perimeter of the cruciform anchor section 1700 is of equal or similar length. A tether section 108 can extend from any one of the five pleats 1702, 1704, 1706, 1708, 1710. Figure 18 shows an example of how the anchor portion 1700 can be folded along the dashed line shown in Figure 17, and Figure 19 shows the anchor portion 1700 resulting from the folding of the anchor portion 1700 and the passage of the tether portion 108 through the intersecting apertures 1703, 1705, 1707, 1709, and 1711 which are aligned with each other in the folded configuration. As shown in Figures 13-19, the advantage of increasing the number of foldable elements is that the thickness of the anchor can be adjusted by folding the anchor portion and passing the tether through it. Increasing the thickness can also increase the stability and durability of the anchor in some examples.

[0084] Figure 20 shows a tether anchor 2000 according to another embodiment, including multiple anchor portions 2002, 2004, 2006, and 2008. Although Figure 20 shows four anchor portions, any suitable number of anchor portions can be implemented in other examples. Each pair of adjacent anchor portions is connected to a connecting member such that anchor portions 2002 and 2004 are connected to connecting member 2003, anchor portions 2004 and 2006 are connected to connecting member 2005, and anchor portions 2006 and 2008 are connected to connecting member 2007. Similar to the embodiments described above, anchor portions 2002, 2004, 2006, and 2008 are folded together to form an anchor similar to anchor 600 in Figure 6.

[0085] Figures 21A and 21B show two configurations of a stop component coupled to the tether portion 108 to prevent the tether portion 108 from passing through the anchor portion 106 or through the cross aperture 400 located on the anchor portion 106. In Figure 21A, the stop component 2100 may be coupled to the tether portion 108 or to the joint between the anchor portion 106 and the tether portion 108. The stop component 2100 may take the form of a knot, a crimp structure, a compression structure, or other suitable structure that limits the ability of the tether portion 108 to pass through the anchor portion 106 or the cross aperture 400. For example, at least a portion of the diameter of the stop component 2100 may be wider than the cross aperture 400. In Figure 21B, a swage stopper 2102 having a T-shaped cross section may be coupled to the tether portion 108. The stopping components 2100 and the swage stopper 2102 can have any suitable shape and cross-section and can be made of any suitable material such as metal, rubber, silicone and other elastic or plastic polymers.

[0086] Figure 22 shows the ends and needles 700 of a tether anchor 102 positioned at each end according to several embodiments. As shown, each end 412 of the tether anchor 102 includes a needle 700 coupled to the end 412 of the tether portion 108 of the tether anchor 102. The tether portion 108 may be attached to or coupled to the distal portion 418 of the tether portion 108 as described in detail above. The double-needle tether anchor 102 can be used in many procedures such as skin closure, soft tissue suturing with minimal trauma or other microsurgical procedures, heart valve repair or other similar procedures. In certain examples, one or both of the needles may be replaced with a tissue anchor as shown and described with reference to Figures 23-24.

[0087] Figure 23 shows the ends of a tether anchor 102 and tissue anchors 1210 positioned at the ends, according to several embodiments. As shown, the tissue anchor 1210 is coupled to the end 412 of the tether anchor 102. The tissue anchor 1210 may be coupled to the end 412 of the tether portion 108 so that the tissue anchor 1210 is mounted on the end 412 as part of the tether anchor 102. In certain examples, the tissue anchor 1210 is attached to or bonded to the end 412. As shown in Figure 22, the tissue anchor 1210 may be coupled to both ends of the tether anchor 102. Furthermore, more than one tissue anchor 1210 may be positioned at both ends of the tether anchor 102 or along the tether anchor 102.

[0088] As shown in Figure 23, the tissue anchor 1210 includes a helical shape. As shown, the tissue anchor 1210 may have one or more coils. The number of turns or coils of the tissue anchor 1210 can be varied to extend or shorten the depth to which the tissue anchor 1210 can be positioned within the valve leaflet or tissue. The tissue anchor 1210 can be coupled to one or both ends of the tether portion 108, as discussed in detail above with reference to Figure 22.

[0089] Figure 24 shows the end of a tether anchor 102 and a tissue anchor 1320 positioned at the end, according to several embodiments. As shown, the tissue anchor 1320 is coupled to the end 412 of the tether anchor 102. The tissue anchor 1320 is screwed into or bonded to the end 412 of the tether portion 108, so that the tissue anchor 1320 is mounted on the end 412 as part of the tether anchor 102. As shown in Figure 22, the tissue anchor 1320 may be coupled to both ends of the tether anchor 102.

[0090] As shown in Figure 24, the tissue anchor 1320 includes multiple spines configured to be embedded within the tissue. The tissue anchor 1320 may include three, four, five, six, or any additional number of spines to facilitate fixation within the tissue. The tissue anchor 1320 may be attached to one or both ends of the tether portion 108, as discussed in detail above with reference to Figure 22. Furthermore, more than one tissue anchor 1320 may be positioned at both ends of the tether anchor 100 or along the tether anchor 100.

[0091] According to various examples, the material of the anchor tether may include, but is not limited to, fluoropolymers including polytetrafluoroethylene (PTFE) and / or stretched polytetrafluoroethylene (ePTFE), nylon, polypropylene, polyester, PVDF, silk, or other similar materials. In some examples, the anchor tether includes a film such as ePTFE, which is combined with an elastomer or elastomeric material, as disclosed herein, to form a composite material. While various examples of anchor tethers have been discussed, it should be understood that the various examples and embodiments discussed herein may be universally applicable to each of the anchor tethers and / or various components of the anchor tethers discussed herein.

[0092] Various features are described in detail in relation to some examples, but not in relation to others. However, it is not intended to exclude combinations of features between the examples. Rather, such combinations are conceivable and form part of this disclosure. The concepts of the inventions of this disclosure have been described both in general and in relation to specific embodiments. It will be apparent to those skilled in the art that various modifications and variations can be made in embodiments without departing from the scope of this disclosure. Accordingly, the embodiments are intended to cover modifications and variations of the invention insofar as they fall within the scope of the appended claims and their equivalent forms. (Aspect) (Aspect 1) A long tether portion extending between the first end and the second end, and An anchor portion that defines a width larger than the width of the aforementioned tether portion, Includes, The tether portion is formed from a flat film structure, The anchor portion is integrally formed with the tether portion of a flat film structure and extends continuously from the second end of the tether portion, and the anchor portion has a first aperture through which the tether portion extends. Tether anchor. (Aspect 2) The tether anchor according to embodiment 1, wherein the flat film structure comprises multiple layers of film material. (Aspect 3) The tether anchor according to embodiment 2, further comprising at least one radiopaque marker inserted between multiple layers of the film material. (Aspect 4) The tether portion and the anchor portion have substantially the same thickness, and the tether portion extends from the anchor portion, as described in Embodiment 1. (Appendix 5) Cut the preform into tether and anchor sections. To form a first aperture in the aforementioned anchor portion, and Passing a certain length of the tether portion through the first aperture of the anchor portion, A tether anchor prepared by a method including, where the tether portion extends continuously from the anchor portion. (Aspect 6) The method according to embodiment 5, wherein cutting the preform into tether and anchor portions defines a continuous and integrated transition between the tether and anchor portions. (Aspect 7) The method according to embodiment 5, wherein cutting the preform into a tether portion and an anchor portion includes forming an anchor portion having a width greater than that of the tether portion. (Pattern 8) The method according to embodiment 5, further comprising forming a plurality of apertures in the anchor portion and passing the tether portion through each of the plurality of apertures, wherein the anchor portion defines one or more pleats when tension is applied to the tether portion. (Aspect 9) The method according to embodiment 5, further comprising forming a preform by winding one or more layers of material onto a mandrel. (Aspect 10) The method according to embodiment 9, further comprising inserting at least one radiopaque marker between layers of material. (Aspect 11) Cut the preform into tether and anchor sections. To form a first aperture in the aforementioned anchor portion, and Passing a certain length of the tether portion through the first aperture of the anchor portion, A method for forming a tethered anchor, wherein the tether portion extends continuously from the anchor portion. (Aspect 12) The method according to embodiment 11, wherein cutting the preform into tether and anchor portions defines a continuous and integrated transition between the tether portion and the anchor. (Aspect 13) The method according to embodiment 11, wherein cutting the preform into a tether portion and an anchor portion includes forming an anchor portion having a width greater than that of the tether portion. (Aspect 14) The method according to embodiment 11, further comprising forming a plurality of apertures in the anchor portion and passing the tether portion through each of the plurality of apertures, wherein when tension is applied to the tether portion, the anchor portion defines one or more pleats. (Aspect 15) The method according to embodiment 11, further comprising forming a preform by winding one or more layers of material onto a mandrel. (Aspect 16) The method according to embodiment 13, further comprising inserting at least one radiopaque marker between layers of material. (Aspect 17) A method for treating cardiac valve insufficiency, comprising positioning a tether anchor at a target location within a patient, wherein the tether anchor comprises a tether portion that is elongated and extends between a first end and a second end, and an anchor portion that defines a width greater than the width of the tether portion, wherein the tether portion is formed from a flat film structure, the anchor portion is integrally formed with the tether portion of the flat film structure and extends continuously from the second end of the tether portion, and the anchor portion has a first aperture through which the tether portion extends. method. (Aspect 18) The method according to embodiment 17, wherein the tether anchor is configured for repairing or replacing cord-like tissue or for treating a defective valve. (Aspect 19) The device comprises a long tether portion extending between a first end and a second end, an anchor portion defining a width greater than the width of the tether portion, and at least one needle coupled to the tether portion, wherein the tether portion is formed from a flat film structure, the anchor portion is integrally formed with the tether portion of the flat film structure and extends continuously from the second end of the tether portion, the anchor portion has a first aperture through which the tether portion extends, Tether anchor. (Aspect 20) The tether anchor according to embodiment 19, wherein the at least one needle includes a first needle coupled to a first end of the tether portion and a second needle coupled to a second end of the tether portion. (Aspect 21) The structure comprises a long tether portion extending between a first end and a second end, an anchor portion defining a width greater than the width of the tether portion, and at least one tissue anchor bonded to the tether portion, wherein the tether portion is formed from a flat film structure, the anchor portion is integrally formed with the tether portion of the flat film structure and extends continuously from the second end of the tether portion, the anchor portion has a first aperture through which the tether portion extends. Tether anchor. (Aspect 22) The tether anchor according to embodiment 21, wherein the at least one tissue anchor includes a first tissue anchor coupled to a first end of the tether portion and a second tissue anchor coupled to a second end of the tether portion.

Claims

1. A long tether portion that extends between the first and second ends of the tether portion, and An anchor portion that defines a width larger than the width of the aforementioned tether portion, Includes, The tether portion is formed from a flat film structure, The anchor portion is formed integrally with the tether portion, the anchor portion has a first aperture through which the tether portion extends, the anchor portion defines a plurality of fold lines, the plurality of fold lines include a first fold line and a second fold line, the first fold line and the second fold line intersect each other. Tether anchor.

2. The tether anchor according to claim 1, wherein the anchor portion includes a second aperture, and when the anchor portion is folded, the first aperture and the second aperture are aligned.

3. The tether anchor according to claim 2, wherein the anchor portion includes a first row of apertures containing the first aperture and a second row of apertures containing the second aperture, and when the anchor portion is folded, the first row of apertures and the second row of apertures are aligned.

4. The tether anchor according to claim 2, wherein the anchor portion comprises a first section and a second section, the first aperture is formed within the first section and the second aperture is formed within the second section, and when the anchor portion is folded to maintain the orientation of the first section and the second section of the anchor portion, the tether portion intersects with the first aperture and the second aperture.

5. The tether anchor according to claim 2, wherein the anchor portion includes a third aperture, and when the anchor portion is folded, the first aperture, the second aperture, and the third aperture are aligned.

6. The tether anchor according to claim 5, wherein the anchor portion forms a first row of apertures including the first aperture, a second row of apertures including the second aperture, and a third row of apertures including the third aperture, and when the anchor portion is folded, the first row of apertures, the second row of apertures, and the third row of apertures are aligned.

7. The tether anchor according to claim 6, wherein the anchor portion comprises a first section, a second section, and a third section, the first row of the aperture being formed within the first section, the second row of the aperture being formed within the second section, and the third row of the aperture being formed within the third section, and when the anchor portion is folded to maintain the orientation of the first section and the second section of the anchor portion, the tether portion intersects with the first row of the aperture, the second row of the aperture, and the third row of the aperture.

8. The tether anchor according to claim 7, wherein the fold includes a first fold formed between the first section and the second section and a second fold formed between the first section and the third section.

9. The tether anchor according to claim 8, wherein the anchor portion forms a tri-fold structure.

10. The tether anchor according to claim 1, wherein the anchor portion comprises a first section, a second section, a third section, a fourth section, and a fifth section, each section defining an aperture.

11. The tether anchor according to claim 10, wherein the first section, the second section, the third section, the fourth section and the fifth section form a cross shape.

12. The first section is located at the center of the cross shape, as described in claim 11.

13. The tether anchor according to claim 12, wherein the folds form each end of the first section.

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