Continuous tether tissue anchors and related systems and methods

Abstract

To provide an excellent tethered anchor.SOLUTION: The invention relates to a tissue anchor in medical procedures. More specifically, the invention relates to a tethered anchor. The tethered anchor includes: a tether portion (108) that is elongate and extends between a first end and a second end, the tether portion being formed of a flat film construct; and an anchor portion (106) that defines a width greater than a width of the tether portion, the anchor portion being integrally formed with the tether portion of the flat film construct and extending continuously from the second end of the tether portion, the anchor portion having a first aperture (402) through which the tether portion extends.SELECTED DRAWING: Figure 5

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of Provisional Application No. 62 / 965,595, filed January 24, 2020, and also claims the benefit of Provisional Application No. 62 / 845,666, filed May 9, 2019, both of which are incorporated herein by reference in their entireties for all purposes. [Background technology]

[0002] background Various tissue anchors have been proposed for delivery into a patient's body. In some instances, such anchors are delivered using a percutaneous or transcatheter approach (e.g., using a delivery catheter). Some tissue anchors have been proposed that utilize pledget and tether placement. Such anchors may be used, for example, to secure anatomical structures to one another, to secure an anatomical structure to an implanted device, or to secure two implanted devices together. Summary of the Invention

[0003] Abstract 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 one-piece implantable tissue anchors including seamlessly interconnected anchor and tether portions. Some examples relate to tether and anchor portions formed from film structures. In some embodiments, the tether and anchor portions are identified continuously as part of a cutting procedure for a tubular member maintained on a mandrel.

[0004] According to one example ("Example 1"), a tether anchor includes a tether portion that is elongate 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 that is greater than the width of the tether portion. 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.

[0005] According to another example ("Example 2") in addition to Example 1, the flat film construction includes multiple layers of film material.

[0006] According to another example ("Example 3") in addition to Example 1, the tether anchor further includes at least one radiopaque marker interposed between the layers of film material.

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

[0008] According to another example ("Example 5"), a tether anchor is prepared by cutting a preform into a tether portion and an anchor portion, wherein the tether portion extends continuously from the anchor portion, forming a first aperture in the anchor portion, and threading a length of the tether portion through the first aperture in the anchor portion.

[0009] According to another example ("Example 6") in addition to Example 5, cutting the preform into tether portions and anchor portions includes defining a continuous and integral transition between the tether portions and the anchors.

[0010] According to another example ("Example 7") in addition to Example 5, cutting the preform into tether portions and anchor portions includes forming anchor portions having a width greater than the tether portions.

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

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

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

[0014] According to another example ("Example 11"), the tether anchor is formed by cutting a preform into a tether portion and an anchor portion, wherein the tether portion extends continuously from the anchor portion, forming a first aperture in the anchor portion, and threading a length of the tether portion through the first aperture in the anchor portion.

[0015] According to another example ("Example 12") in addition to Example 11, cutting the preform into tether portions and anchor portions includes defining a continuous and integral transition between the tether portions and the anchors.

[0016] According to another example ("Example 13") in addition to Example 11, cutting the preform into tether portions and anchor portions includes forming anchor portions having a width greater than the tether portions.

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

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

[0019] According to another example ("Example 16") in addition to Example 15, the method of forming the tether anchor further includes inserting at least one radiopaque marker between the layers of material.

[0020] According to one example ("Example 17"), a method for treating cardiac valve dysfunction includes placing a tether anchor at a target location within a patient, the tether anchor including: an elongated 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 a 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, and the anchor portion has a first aperture through which the tether portion extends.

[0021] According to another example ("Example 18") in addition to Example 17, a method for treating heart valve dysfunction includes a tether anchor configured for repair or replacement of chordal tissue or repair of a defective valve.

[0022] According to one example ("Example 19"), a tether anchor includes an elongated tether portion extending between a first end and a second end, wherein the tether portion is formed from a flat film structure; an anchor portion defining a width greater than a 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] According to another example ("Example 20") in addition to Example 19, 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"), a tether anchor includes a tether portion that is elongate and extends between a first end and a second end, wherein the tether portion is formed from a flat film structure; an anchor portion that defines a width greater than a 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] According to another example ("Example 22") in addition to Example 21, the tether anchor also includes at least one tissue anchor including 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 foregoing examples are exemplary only and should not be read to limit or otherwise narrow the scope of any of the inventive concepts otherwise provided by this disclosure. While multiple examples are disclosed, still other embodiments will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative examples. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not as restrictive. [Brief explanation of the drawings]

[0027] BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings are included to provide a further understanding of the disclosure, and are incorporated in and constitute a part of this specification, illustrate embodiments and, together with the description, serve to explain the principles of the disclosure.

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

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

[0030] [Figure 3] FIG. 3 illustrates a suture in a rolled configuration, according to some embodiments.

[0031] [Figure 4] FIG. 4 illustrates a sequentially formed pledget anchor and suture, according to some embodiments.

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

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

[0034] [Figure 7] FIG. 7 shows a pledget anchor and suture end, according to some embodiments.

[0035] [Figure 8] FIG. 8 illustrates a pledget anchor and suture as used in a cord repair procedure according to some embodiments.

[0036] [Figure 9] FIG. 9 shows a pledget anchor and suture, according to some embodiments.

[0037] [Figure 9A] FIG. 9A shows a pledget anchor and suture, according to some embodiments.

[0038] [Figure 9B] FIG. 9B shows a pledget anchor and suture with an interlocking mechanism, according to some embodiments.

[0039] [Figure 10] FIG. 10 shows the pledget anchor and suture of FIG. 11 in a folded configuration.

[0040] [Figure 11] FIG. 11 illustrates a pair of pledget anchors and sutures connected by an interlocking mechanism, according to some embodiments.

[0041] [Figure 12] FIG. 12 illustrates a pledget anchor and suture, according to some embodiments.

[0042] [Figure 13] FIG. 13 shows a pledget anchor and suture, according to some embodiments.

[0043] [Figure 14] FIG. 14 shows the pledget anchor and suture of FIG. 15 in a folded configuration, according to some embodiments.

[0044] [Figure 15] FIG. 15 shows a pledget anchor and suture, according to some embodiments.

[0045] [Figure 16] FIG. 16 shows the pledget anchor and suture of FIG. 17 in a folded configuration, according to some embodiments.

[0046] [Figure 17] FIG. 17 shows a pledget anchor and suture, according to some embodiments.

[0047] [Figure 18] FIG. 18 shows the pledget anchor and suture of FIG. 19 folded, according to some embodiments.

[0048] [Figure 19] FIG. 19 illustrates the pledget anchor and suture of FIG. 19, according to some embodiments.

[0049] [Figure 20] FIG. 20 illustrates a pledget anchor and suture with multiple anchor portions, according to some embodiments.

[0050] [Figure 21A] FIG. 21A shows a pledget anchor and suture with a tubular stop component, according to some embodiments.

[0051] [Figure 21B] FIG. 21B shows a pledget anchor and suture with a washer stopper, according to some embodiments.

[0052] [Figure 22] FIG. 22 shows the end of a needle with a pledget anchor located at each end, according to some embodiments.

[0053] [Figure 23] FIG. 23 shows the end of a tissue anchor and pledget anchor disposed at the end, according to some embodiments.

[0054] [Figure 24] FIG. 24 shows the end of a tissue anchor and pledget anchor disposed at the end, according to some embodiments.

[0055] Those skilled in the art will readily appreciate that the various aspects of the present disclosure may be implemented by any number of methods and apparatus configured to perform the intended functions. It should also be noted that the accompanying drawings referred to herein are not necessarily drawn to scale and may be exaggerated to illustrate various aspects of the present disclosure, and in that regard the drawings should not be construed as limiting. DETAILED DESCRIPTION OF THE INVENTION

[0056] Detailed Description Definitions and Terminology This disclosure is not intended to be read in a limiting manner, for example, the terms used in this application should be read broadly with respect to the meanings ascribed to such terms by terms of the art.

[0057] With respect to the term imprecision, "about" and "approximately" are used interchangeably to refer to measurements that include the stated measurement and can include measurements that are reasonably close to the stated measurement. A measurement that is reasonably close to the stated measurement deviates from the stated measurement by a reasonably small amount, as would be understood and readily ascertained by one of ordinary skill in the relevant art. Such deviations can result, for example, from measurement error or from fine-tuning made to optimize performance.

[0058] As used herein, "couple" means to join, connect, attach, adhere, affix or bond, whether directly or indirectly, and whether permanently or temporarily.

[0059] Description of Various Embodiments Various disclosed concepts relate to continuous or one-piece implantable tissue anchors that include seamlessly interconnected anchor and tether portions. Some examples relate to anchor or pledget portions and tether or suture portions that are continuously formed from a film structure (e.g., a tubular film structure).

[0060] As described in further detail below, the implantable anchors discussed herein can be used in a variety of medical procedures. For example, in certain instances, the implantable anchors can be used for chordal tissue repair. Additionally, the implantable anchors can be used to treat defective valves (e.g., mitral valves, tricuspid valves). The implantable anchors can be wrapped around the heart or valve annulus to ensure closure of a valve experiencing regurgitation. Additionally, the implantable anchors can be used in cardiac annuloplasty procedures or to close openings or apertures formed in the heart wall, such as ventricular or atrial septal defects.

[0061] 1 shows a preform 100 that has been 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 wrapping a film in a helical pattern (e.g., tape wrap) or a tubular pattern (e.g., cigarette wrap) around a mandrel 114, which acts as a support structure for the preform 100 during its formation. While wrapping is one means of manufacture, others can be used as desired, including, but not limited to, extrusion, molding, drawing, or other processes.

[0062] In some examples, preform 100 is a film construction made from multiple layers of film material (e.g., expanded polytetrafluoroethylene or ePTFE film or related composite materials), and preform 100 is formed by placing multiple layers of film material together and exposing the layered film material to a predetermined pressure and / or temperature to bond the layers. In one example, radiopaque marker material is disposed within preform 100 between the layers of film material in any desired configuration or pattern. Mandrel 114 can be tubular and have a circular cross-section; in other examples, mandrel 114 is rectangular, oval, or other suitable shape in cross-section, including tapers, steps, or other longitudinal variations as desired.

[0063] After 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 done using a laser, but in other examples, other cutting / shaping methods can be used, such as water jet cutting, plasma cutting, or mechanical (blade) cutting. Also, while preform 100 is shown in FIG. 1 to form two tether anchors, other examples can cut the preform 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, only first tether anchor 102 is referenced moving forward, but it should be understood that the same discussion and descriptions can apply to each portion of second tether anchor 104.

[0064] The preform 100 is optionally cut so that the tether portion 108 has a constant width and the anchor portion 106 has a width greater than the width of the tether portion 108, as shown in FIG. 2 . While a substantially constant width is shown for each tether portion and anchor portion 106, 108, it should be understood that cuts with varying widths and non-linear (e.g., serpentine) cuts are also contemplated. Regardless, the anchor portion 106 is integrally formed with the tether portion 108 in a 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 homogenous material. Following cutting, the tether portion 108 can be reshaped from its flat profile to have a rounder profile than the anchor portion 106. As shown, there is a smooth, continuous, and integral 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] FIG. 3 shows tether portion 108 in a curled or twisted configuration (e.g., after removal from mandrel 114). The number of turns or twists per unit length can be adjusted as desired. In some examples, tether portion 108 is twisted and compressed (e.g., a "candy cane" configuration) by pulling tether portion 108 through a die configured to twist and / or compress tether portion 108. Tether portion 108 is optionally bonded, sintered, or otherwise fabricated into a more circular cross-section, such as by this twisting and compression process. For example, tether portion 108 can be tightly curled in a compressed, twisted configuration such that its cross-section is circular or oval, as generally shown in FIG. 4. This curling / compression may change the overall profile of tether portion 108, as well as the density of tether portion 108, but the mass of tether portion 108 remains unchanged.

[0066] FIG. 4 shows tether anchor 102 after tether portion 108 has been twisted and compressed to achieve a more circular cross-section, and tether portion 108 smoothly transitions into anchor portion 106, which includes multiple intersecting apertures 400, such as first through fifth intersecting apertures 402, 404, 406, 408, 410, through which tether portion 108 can pass in an alternating, zigzag, or lacing pattern, as shown in FIG. 5. The crossover apertures 400 can be pre-formed in the anchor portions 106 during manufacturing (e.g., the crossover apertures 400 can be laser cut when the remaining portions of the tether anchors 102 and 104 are cut), so that only the tether portions 108 need to be guided through, extended therethrough, or sequentially placed into the crossover apertures 400, creating an arrangement in which the ends 412 can be tensioned to collapse the anchor portions 106 and transition them from the delivery configuration to the anchor configuration. In some examples, the anchor portions 106 are formed without pre-forming the crossover apertures or openings, and the crossover apertures are formed after the anchor portions 106 are formed by perforating the surface of the anchor portions 106 to provide openings through which the tether portions 108 can pass.

[0067] As part of manufacturing, or prior to or during implantation, a needle or other instrument can be utilized to deliver end portions 412 through and / or form crossing apertures 400. The size of crossing apertures 400 can be the same as, smaller than, or larger than the thickness of tether portions 108. In some instances, crossing apertures 400 are smaller than the thickness of tether portions 108, but the material of anchor portions 106 is expandable or elastic, allowing tether portions 108 to pass through the crossing apertures without damaging either tether portions 108 or anchor portions 106. Crossing apertures 400 can be evenly spaced or spaced at varying intervals. In one example, crossing apertures 400 are arranged along a relatively straight line, but crossing apertures 400 may be staggered or otherwise arranged. And, while FIG. 4 shows five crossing apertures, it is understood that any suitable number of crossing apertures can be used.

[0068] In some examples, the tether portion defines a proximal section 414 extending from the end 412 to a distal section 418 adjacent the anchor portion 106, and 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 make up any of various 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 the sections 414, 416, 418 makes up at least 5% of the length of the tether portion 108.

[0069] 5 illustrates an intermediate configuration of tether anchor 102 in which end 412 is inserted through each of intersecting apertures 400 of anchor portion 106, causing anchor portion 106 to bend or fold to form multiple pleats 500. In some examples, as shown, the number of pleats 500 formed is the same as the number of intersecting apertures 400, such as first through fifth intersecting apertures 402, 404, 406, 408, 410, on anchor portion 106. This configuration is achieved when end 412 is threaded through first intersecting aperture 402, such that anchor portion 106 is folded between first intersecting aperture 402 and second intersecting aperture 404, and end 412 passes through second intersecting aperture 404. These steps are repeated until end 412 passes through all of the intersecting apertures to form multiple pleats 500 in anchor portion 106, such as first pleat 502, second pleat 504, third pleat 506, fourth pleat 508, and fifth pleat 510, as shown in FIG. 5 . Pleat 500 resembles a zigzag or accordion shape when viewed from the side. This configuration allows anchor portion 106 to initially assume a longer, straighter profile, and then, upon tensioning of tether portion 108, anchor portion 106 collapses into an expanded transverse profile relative to the longitudinal axis. In this manner, anchor portion 106 is initially deployed (e.g., by insertion through a tissue structure) in a lower profile or delivery configuration and then tensioned to the expanded profile or anchor configuration.

[0070] 6 shows the expanded profile or final anchor configuration after end 412 has been pulled away from anchor portion 106. As shown, pleats 500 collapse onto one another after tensioning tether portion 108 to form anchor 600 that is thicker than the thickness of anchor portion 106 in its initial form shown in FIG.

[0071] 7 illustrates 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 (e.g., tied or adhered) to it such that the needle 700 is implemented as part of the tether portion 108. In some examples, the needle 700 can be used for skin closure, minimally traumatic soft tissue suturing, or other microsurgical procedures. The needle 700 can have a sharpened end for penetrating tissue and, in some examples, can also include a cutting blade edge capable of severing open tissue during a microsurgical procedure. The needle 700 can have a generally C-shaped, J-shaped, or S-shaped configuration, according to some examples. Furthermore, needle 700 can be of any suitable shape (in some examples, straight, curved, hooked, bent, twisted, etc.), size (in some examples, less than 3 mm in length, 3 mm to 5 mm, 5 mm to 7 mm, or more than 7 mm in length), and material suitable for the surgical procedure (in some examples, nitinol, stainless steel, or other types of metal).

[0072] One example application of the tether anchor 102 as described herein is chordal repair, such as with respect to cardiac valve chordae. When the valve chordae are disrupted and the valve leaflets are unable to open and close sufficiently to control blood flow therethrough, a tether anchor as described herein can be used to support the opening and closing of the valve leaflets by attaching an anchor portion to the valve leaflet and connecting the other end of the tether portion to a papillary muscle to create a prosthetic valve chordae. When the papillary muscle contracts, the tether portion pulls on the anchor portion, opening the leaflets and allowing blood flow therethrough. In this example, the anchor portion is attached to the side of the valve leaflet opposite the papillary muscle, so that 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] FIG. 8 shows an example of this application. In a healthy valve, a set of structures called chordae tendineae 806 connect each leaflet 804 to the papillary muscles 802. However, when the chordae tendineae are torn or broken, tether anchors 102 are first attached to one or more leaflets 800 where the chordae are torn by placing or positioning anchor portion 106 on the distal surface of the leaflet 800 relative to the papillary muscles 802. Next, as shown in FIG. 5 , tensioning tether portion 108 causes anchor portion 106 to bend or fold upon itself to form multiple pleats 500. Tether portion 108 is passed through each of the intersecting apertures 400 in a zigzag pattern, after which tether portion 108 is tensioned to completely collapse pleats 500 and form anchors 600. The end 412 of the tether portion 108 is then attached to the papillary muscle 802 so that movement of the papillary muscle 802 induces movement of the valve leaflets 800 .

[0074] Another example of a use for tether anchors 102 is, for example, heart annuloplasty, where the ring around a heart valve (annulus) widens and changes from its normal shape. Tether anchors 102 can be deployed to tighten or reinforce the valve annulus, thereby preventing blood from leaking through the enlarged valve. Tether anchors as described herein can be used to ensure that an annuloplasty device remains secured to the annulus and continues to assist in restoring normal valve function.

[0075] Another use of tether anchor 102 is to close an opening or aperture formed in the wall of the heart, such as a ventricular or atrial septal defect. Tether anchor 102 is used to help close the opening from within the heart wall, so that constant pressure applied from within the heart prevents blood flow through the heart from detaching the anchor from the wall over time.

[0076] In some instances, echogenicity is a factor to consider when implementing a tether anchor so that the anchor can be accurately captured during medical imaging, such as medical ultrasound. For example, a material is more echogenic if it is loaded with hyperechoic air, and is better able to capture such hyperechoic air if it includes a hydrophobic, water-immiscible matrix. In one example, the tether anchor is made from a hydrophobic material and / or coated with a layer of a hydrophobic agent to prevent the hyperechoic air from escaping into the environment. In another example, the 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 fluoroscopy or x-ray.

[0077] 9 and 10 show a tether anchor 900 comprising a first tether portion 108 or suture, a second tether portion 902, and an anchor portion 106 or pledget, along with a plurality of crossover apertures 400, according to one embodiment. 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, such that when the anchor 600 is formed by threading the first tether portion 108 through the crossover apertures 400 as described above, the second tether portion 902 extends from the anchor 600, as shown in FIG. 10. In some instances, the second tether portion 902 can be used to attach additional components to the anchor 600. In some examples, the second tether portion 902 can extend from the same end (904 or 906) as the first tether portion 108, as shown in FIG. 9A. FIG. 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 interlocking mechanism 908 to form a parachute-like configuration. In some examples, a first needle (not shown) can be attached to the free end of the first tether portion 108, and a second needle (not shown) can 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 or connected to the anchor portion 106. These needles can be needles 700, as described above and shown in FIG. 7. In some examples, the two needles differ from one another, such as by having different shapes, sizes, and / or materials.

[0078] 11 and 12 show a pair of tether anchors 102 and 1100 connected to one another via an interlocking 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 the second anchor portion 1102. The ends of the two tether portions 108 and 1106 can be interlocked using the interlocking mechanism 1104, such that the two tether anchors 102 and 1100 can essentially be utilized as a single continuous tether with an anchor 600 or 1200 at each end, as shown in FIG.

[0079] In this case, anchors 600 and 1200 are disposed on two opposite sides of two walls 1202 and 1204, and interlocking mechanism 1104 is disposed in the space between walls 1202 and 1204, separating them from the two anchors 600 and 1200. Anchors 600 and 1200 are formed before two tether portions 108 and 1106 are interlocked. First, first anchor 600 is formed by inserting tether portion 108 through crossover aperture 400 as described above, and second anchor 1200 is similarly formed by inserting second tether portion 1106 through crossover aperture 1108 of second anchor portion 1102. The two free ends of tether portions 108 and 1106 are then joined together using interlocking 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 (FIG. 9B) or 1106 (FIGS. 11 and 10). In some examples, the interlocking mechanisms 908 and 1104 also have tightening capabilities that can adjust the length of the tether formed by interlocking the two tether portions 108 and 902 or 1106. For example, there can be a screw or knob on the interlocking mechanism 1104 that, when activated, draws the two anchors 600 and 1200 closer together.

[0081] 13 and 14 show an anchor portion 1300 having a first row of intersecting apertures 1306 disposed in a first section 1302 of the anchor portion 1300 and a second row of intersecting apertures 1308 disposed in a second section 1304 of the anchor portion 1300, according to one embodiment. The tether portion 108 extends from the anchor portion 1300 through the first section 1302, the second section 1304, or therebetween. The anchor portion 1300 can be folded along the dashed lines as shown in FIG. 13. When the anchor portion 1300 is folded, the first row of intersecting apertures 1306 aligns with the second row of intersecting apertures 1308. After folding anchor portion 1300, tether portion 108 intersects with first and second rows of intersecting apertures 1306, respectively, to maintain the orientation of first and second sections 1302 and 1304 of anchor portion 1300, as shown in Figure 14. Applying a force to tether portion 108 in a direction away from anchor portion 1300 causes folded anchor portion 1300 to collapse, similar to the example shown in Figure 2, after which anchor portion 1300 becomes a folded anchor (not shown).

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

[0083] 17-19 show a cruciform anchor portion 1700 having five sections or pleats 1702, 1704, 1706, 1708, and 1710 and five intersecting apertures 1703, 1705, 1707, 1709, and 1711, each located at or near the center of each section. In some examples, each pleat 1702, 1704, 1706, 1708, and 1710 can be substantially square in shape, with each side of the perimeter of the cruciform anchor portion 1700 being equal or similar in length. The tether portion 108 can extend from any one of the five pleats 1702, 1704, 1706, 1708, and 1710. Figure 18 shows an example of how anchor portion 1700 can be folded along the dashed lines shown in Figure 17, and Figure 19 shows anchor portion 1700 resulting from folding anchor portion 1700 and passing tether portion 108 through intersecting apertures 1703, 1705, 1707, 1709, and 1711 that align with one another in the folded configuration. As shown in Figures 13-19, benefits of increasing the number of foldable elements include being able to adjust the thickness of the anchor resulting from folding the anchor portion and passing the tether therethrough. Increasing the thickness can also increase the stability and durability of the anchor in some instances.

[0084] FIG. 20 illustrates another embodiment of a tether anchor 2000 that includes multiple anchor portions 2002, 2004, 2006, and 2008. While FIG. 20 illustrates four anchor portions, in other examples, any suitable number of anchor portions can be implemented. 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. As with the previous embodiment, anchor portions 2002, 2004, 2006, and 2008 are folded onto one another to form an anchor similar to anchor 600 of FIG. 6.

[0085] 21A and 21B show two configurations of a stop component coupled to a tether portion 108 to prevent the tether portion 108 from passing through the anchor portion 106 or through a crossover aperture 400 disposed in the anchor portion 106. In FIG. 21A, a stop component 2100 can be coupled to the tether portion 108 or to the junction between the anchor portion 106 and the tether portion 108. The stop component 2100 can take the form of a knot, a crimped structure, a crimped structure, or other suitable structure that restricts the ability of the tether portion 108 to pass through the anchor portion 106 or the crossover aperture 400. For example, the diameter of at least a portion of the stop component 2100 can be wider than the crossover aperture 400. In FIG. 21B, a swage stopper 2102 having a T-shaped cross-section can be coupled to the tether portion 108. The stop component 2100 and swage stopper 2102 may have any suitable shape and cross-section and may be constructed from any suitable material such as, for example, metal, rubber, silicone, and other elastic or plastic polymers.

[0086] FIG. 22 illustrates the ends of the tether anchor 102 and a needle 700 disposed at each end, according to some embodiments. As shown, each of the ends 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 can be attached or coupled to the distal portion 418 of the tether portion 108, as described in detail above. The dual-needle tether anchor 102 can be used in many procedures, such as skin closure, minimally traumatic soft tissue suturing or other microsurgical procedures, heart valve repair, or other similar procedures. In certain instances, one or both of the needles can be replaced with a tissue anchor, as shown and described with reference to FIGS. 23-24 .

[0087] 23 illustrates an end of a tether anchor 102 and a tissue anchor 1210 disposed thereon, according to some embodiments. As shown, the tissue anchor 1210 is coupled to the end 412 of the tether anchor 102. The tissue anchor 1210 can be coupled to the end 412 of the tether portion 108 such that the tissue anchor 1210 is mounted to the end 412 as part of the tether anchor 102. In certain examples, the tissue anchor 1210 is attached or glued to the end 412. As shown in FIG. 22, the tissue anchor 1210 can be coupled to both ends of the tether anchor 102. Additionally, more than one tissue anchor 1210 can be disposed at both ends of or along the tether anchor 102.

[0088] 23, the tissue anchor 1210 includes a helical shape. As shown, the tissue anchor 1210 can have one or more coils. The number of turns or coils in the tissue anchor 1210 can be varied to increase or decrease the depth to which the tissue anchor 1210 can be placed 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 FIG. 22.

[0089] 24 illustrates an end of a tether anchor 102 and a tissue anchor 1320 disposed thereon, according to some embodiments. As shown, the tissue anchor 1320 is coupled to the end 412 of the tether anchor 102. The tissue anchor 1320 is threaded or glued to the end 412 of the tether portion 108, such that the tissue anchor 1320 is mounted to the end 412 as part of the tether anchor 102. As shown in FIG. 22, the tissue anchor 1320 can be coupled to both ends of the tether anchor 102.

[0090] As shown in FIG. 24 , tissue anchor 1320 includes a plurality of barbs configured to be embedded within tissue. Tissue anchor 1320 can include three, four, five, six, or any additional number of barbs to facilitate anchoring within tissue. Tissue anchor 1320 can be coupled to one or both ends of tether portion 108, as discussed in detail above with reference to FIG. 22 . Additionally, more than one tissue anchor 1320 can be positioned at both ends of tether anchor 100 or along tether anchor 100.

[0091] According to various examples, anchor tether materials can include, but are not limited to, fluoropolymers, including polytetrafluoroethylene (PTFE) and / or expanded polytetrafluoroethylene (ePTFE), nylon, polypropylene, polyester, PVDF, silk, or other similar materials. In some examples, the anchor tether comprises a membrane, such as ePTFE, combined with an elastomer or elastomeric material, e.g., a fluoroelastomer, as disclosed herein, to form a composite material. While various examples are discussed with respect to anchor tethers, it is understood that the various examples and embodiments discussed herein may be generally applicable to each of the anchor tethers and / or various components of the anchor tethers discussed herein.

[0092] Various features are specifically described with respect to some examples and not with respect to other examples. However, it is not intended to exclude the combination of features between examples. Instead, such combinations are specifically contemplated and form part of this disclosure. The inventive concepts of the present disclosure have been described both generically and with respect to specific embodiments. It will be apparent to those skilled in the art that various changes and modifications can be made in the embodiments without departing from the scope of the present disclosure. Therefore, it is intended that the embodiments cover modifications and variations of the present invention provided they come within the scope of the appended claims and their equivalents. (Aspect) (Aspect 1) a tether portion that is elongate and extends between a first end and a second end; and an anchor portion defining a width greater than a width of the tether portion; Including, 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 having a first aperture through which the tether portion extends; Tether anchor. (Aspect 2) 2. The tether anchor of embodiment 1, wherein the flat film construction comprises multiple layers of film material. (Aspect 3) 3. The tether anchor of embodiment 2, further comprising at least one radiopaque marker interposed between said layers of film material. (Aspect 4) 2. The tether anchor of embodiment 1, wherein the tether portion and the anchor portion have substantially the same thickness, and the tether portion extends from the anchor portion. (Aspect 5) cutting the preform into tether portions and anchor portions; forming a first aperture in the anchor portion; and threading a length of the tether portion through the first aperture of the anchor portion; wherein the tether portion extends continuously from the anchor portion. (Aspect 6) 6. The method of embodiment 5, wherein cutting the preform into tether and anchor portions comprises defining a continuous and integral transition between the tether and anchor portions. (Aspect 7) 6. The method of embodiment 5, wherein cutting the preform into tether and anchor portions comprises forming anchor portions having a width greater than the tether portions. (Aspect 8) The method of embodiment 5 further comprises forming a plurality of apertures in the anchor portion and threading the tether portion through each of the plurality of apertures, such that the anchor portion defines one or more pleats when tension is applied to the tether portion. (Aspect 9) The method of embodiment 5, further comprising forming a preform by winding one or more layers of material onto a mandrel. (Aspect 10) The method of embodiment 9, further comprising inserting at least one radiopaque marker between the layers of material. (Aspect 11) cutting the preform into tether portions and anchor portions; forming a first aperture in the anchor portion; and threading a length of the tether portion through a first aperture in the anchor portion; wherein the tether portion extends continuously from the anchor portion. (Aspect 12) 12. The method of embodiment 11, wherein cutting the preform into tether and anchor portions comprises defining a continuous and integral transition between the tether portion and the anchor. (Aspect 13) 12. The method of embodiment 11, wherein cutting the preform into tether and anchor portions comprises forming anchor portions having a width greater than the tether portions. (Aspect 14) 12. The method of claim 11, further comprising forming a plurality of apertures in the anchor portion and threading the tether portion through each of the plurality of apertures, such that when tension is applied to the tether portion, the anchor portion defines one or more pleats. (Aspect 15) 12. The method of embodiment 11, further comprising forming a preform by winding one or more layers of material onto a mandrel. (Aspect 16) The method of embodiment 13, further comprising inserting at least one radiopaque marker between the layers of material. (Aspect 17) 1. A method of treating cardiac valve dysfunction, comprising placing a tether anchor at a target location within a patient, the tether anchor comprising: an elongate tether portion extending between a first end and a second end; and an anchor portion defining a width greater than a width of the tether portion, the tether portion being formed from a flat film structure, the anchor portion being integrally formed with the tether portion of the flat film structure and extending continuously from the second end of the tether portion, and the anchor portion having a first aperture through which the tether portion extends. method. (Aspect 18) 20. The method of embodiment 17, wherein the tether anchor is configured for repair or replacement of chordal tissue or treatment of a defective valve. (Aspect 19) a tether portion having an elongate length and extending between a first end and a second end, an anchor portion defining a width greater than a width of the tether portion, and at least one needle coupled to the tether portion, the tether portion being formed from a flat film structure, the anchor portion being integrally formed with the tether portion of the flat film structure and extending continuously from the second end of the tether portion, and the anchor portion having a first aperture through which the tether portion extends; Tether anchor. (Aspect 20) 20. The tether anchor of claim 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) a tether portion having an elongate length and extending between a first end and a second end, an anchor portion defining a width greater than a width of the tether portion, and at least one tissue anchor coupled to the tether portion, the tether portion being formed from a flat film structure, the anchor portion being integrally formed with the tether portion of the flat film structure and extending continuously from the second end of the tether portion, and the anchor portion having a first aperture through which the tether portion extends; Tether anchor. (Aspect 22) 22. The tether anchor of claim 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 tether portion that is elongate and extends between a first end and a second end of the tether portion; an anchor portion defining a width greater than a width of the tether portion; Including, the tether portion is formed from a flat film structure; the anchor portion is integrally formed with the tether portion, the anchor portion having a first aperture through which the tether portion extends, the anchor portion defining a plurality of fold lines, the plurality of fold lines including a first fold line and a second fold line, the first fold line and the second fold line intersecting one another; Tether anchor.

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

4. 3. The tether anchor of claim 2, wherein the anchor portion includes a first section and a second section, the first aperture formed in the first section and the second aperture formed in the second section, and the tether portion intersects the first aperture and the second aperture when the anchor portion is folded to maintain an orientation of the first and second sections of the anchor portion.

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

6. 6. The tether anchor of claim 5, wherein the anchor portion defines 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 wherein the first row of apertures, the second row of apertures, and the third row of apertures are aligned when the anchor portion is collapsed.

7. 7. The tether anchor of claim 6, wherein the anchor portion includes a first section, a second section, and a third section, the first row of apertures formed in the first section, the second row of apertures formed in the second section, and the third row of apertures formed in the third section, and the tether portion intersects the first row of apertures, the second row of apertures, and the third row of apertures when the anchor portion is folded to maintain an orientation of the first and second sections of the anchor portion.

8. 8. The tether anchor of claim 7, wherein the folds include 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 of claim 8 , wherein the anchor portion forms a tri-fold configuration.

10. The tether anchor of claim 1 , wherein the anchor portion includes 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 of 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 tether anchor of claim 11 , wherein the first section is located at the center of the cross.

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

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