Patent Description:
Various tissue anchors have been proposed for delivery into a body of a patient. In some examples, such anchors are delivered using a percutaneous or transcatheter approach (e.g., using a delivery catheter). Some tissue anchors have been proposed that utilize a pledget and tether arrangement. Such anchors may be utilized to secure anatomical structures to one another, to secure an anatomical structure to an implanted device, or to secure two implanted devices together, for example.

<CIT> discloses suture constructs for soft tissue to bone repairs. The suture construct is a soft, suture-based anchor which is self-cinching and has a specific, accordion-type configuration (i.e., with the ability to fold from a first, extended position to a second, folded or compressed position). The suture-based anchor may be formed essentially of a flexible material such as a high strength surgical suture, suture chain, or suture. <CIT> discloses methods and devices for transvascular prosthetic chordae tendinea implantation. A catheter is advanced into the left atrium, through the mitral valve, and into the left ventricle. A ventricular anchor is deployed from the catheter and into a wall of the left ventricle, leaving a ventricular suture attached to the ventricular anchor and extending proximally through the catheter. A leaflet anchor is deployed to secure a mitral valve leaflet to a leaflet suture, with the leaflet suture extending proximally through the catheter. The leaflet suture is secured to the ventricular suture to limit a range of travel of the leaflet in the direction of the left atrium. Also disclosed is an assembled in situ mitral valve leaflet restraint, having a neo papillary muscle and a neo chordae tendinea.

<CIT> discloses various embodiments of surgical procedures, systems, implants, devices, tools, and methods, useful for treating pelvic conditions in a male or female, the pelvic conditions including incontinence (various forms such as fecal incontinence, stress urinary incontinence, urge incontinence, mixed incontinence, etc.), vaginal prolapse (including various forms such as enterocele, cystocele, rectocele, apical or vault prolapse, uterine descent, etc.), and other conditions caused by muscle and ligament weakness, the devices and tools including devices and tools for anchoring an implant to supportive tissue and adjusting the implant.

<CIT> discloses an anchor assembly including at least one anchor member, such as a pair of anchor members that are configured to be implanted in a target anatomical location in a first configuration, and can subsequently be actuated to an expanded configuration that secures the anchor members in the target anatomy. The anchor assembly can further include a connector member that attaches the pair of anchor members together across a gap so as to approximate the anatomical defect.

The invention provides a tethered anchor as defined in appended claim <NUM> and an associated process for preparing a tethered anchor as defined by appended claim <NUM>. Various examples relate to tissue anchors, methods used to form tissue anchors, and associated methods of forming tissue anchors. Various disclosed concepts relate to continuous, or integral implantable tissue anchors including an anchor portion and a tether portion that are seamlessly interconnected. The invention relate to a tether portion and anchor portion formed from a film construct. In some implementations, the tether and anchor portions are confirmed continuously as part of a cutting procedure for a tubular member maintained on a mandrel.

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 rather than restrictive in nature.

Persons skilled in the art will readily appreciate that various aspects of the present disclosure can be realized by any number of methods and apparatuses configured to perform the intended functions. It should also be noted that the accompanying drawing figures referred to herein are not necessarily drawn to scale, but may be exaggerated to illustrate various aspects of the present disclosure, and in that regard, the drawing figures should not be construed as limiting.

This disclosure is not meant to be read in a restrictive manner. For example, the terminology used in the application should be read broadly in the context of the meaning those in the field would attribute such terminology.

With respect to terminology of inexactitude, the terms "about" and "approximately" may be used, interchangeably, to refer to a measurement that includes the stated measurement and that also includes any measurements that are reasonably close to the stated measurement. Measurements that are reasonably close to the stated measurement deviate from the stated measurement by a reasonably small amount as understood and readily ascertained by individuals having ordinary skill in the relevant arts. Such deviations may be attributable to measurement error or minor adjustments made to optimize performance, for example.

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

Various disclosed concepts relate to continuous, or integral implantable tissue anchors including an anchor portion and a tether portion that are seamlessly interconnected. Some examples relate to an anchor, or pledget portion and tether, or suture portion formed continuously from a film construct (e.g., a tubular film construct).

As described in further detail below, the implantable anchors discussed herein may be used in a variety of medical procedures. For example and in certain instances, the implantable anchors may be used in chordal repair. In addition, the implantable anchors may be used for treating a defective valve (e.g., mitral valve, tricuspid valve). The implantable anchors may be wrapped about a circumference of the heart or valve annulus to ensure closure of a valve that is experiencing regurgitation. In addition, the implantable anchors may be used in valve annuloplasty procedures in a heart or closing an opening or aperture formed in a wall of the heart, such as a ventricular or atrial septal wall defect.

<FIG> shows a preform <NUM> that is cut to form a pair of tethered anchors <NUM> and <NUM>. The first tethered anchor <NUM> has an anchor portion <NUM> and a tether portion <NUM>, and the second tethered anchor <NUM> also has a corresponding anchor portion <NUM> and tether portion <NUM>. The preform <NUM> may be formed by wrapping a film around a mandrel <NUM> in a helical pattern (e.g., tape-wrapped) or tubular pattern (e.g., cigarette-wrapped), where the mandrel <NUM> acts as a support structure for the preform <NUM> during formation thereof. Although wrapping is one means of manufacture, others may be employed as desired, including but not limited to extruding, molding, drawing, or other process.

In some examples, the preform <NUM> is a film construct made from a plurality of layers of film material (e.g., expanded polytetrafluorethylene, or ePTFE film, or associated composite materials), and the preform <NUM> is formed by disposing a plurality of layers of the film material onto one another 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 positioned between the layers of film material in any desired configuration or pattern within the preform <NUM>. Although the mandrel <NUM> may be is tubular, with a circular cross-section, in other examples, the mandrel <NUM> has a cross-section that is rectangular, ovular, or any other suitable shape, including tapers, steps or other variations in length as desired.

After the preform <NUM> is prepared, the preform <NUM> is cut to form one or more tethered anchors, such as the tethered anchors <NUM> and <NUM>. In one example, the cutting is done using a laser, while in another example, other cutting / forming methods such as water jet cutting, plasma cutting, or mechanical (blade) cutting for example, can be used. Also, although the preform <NUM> is shown to form two tethered anchors in <FIG>, other examples can have the preform cut so that one tethered anchor can be formed from a single preform, or three or more tethered anchors can be formed from the preform. For simplicity, moving forward, only the first tethered anchor <NUM> is mentioned, but it should be understood that the same explanations and descriptions may be applied to the respective portions of the second tethered anchor <NUM>.

The preform <NUM> is optionally cut such that the tether portion <NUM> has a consistent width, as shown in <FIG>, and the anchor portion <NUM> has a width greater than the width of the tether portion <NUM>. Although a substantially constant width is shown for the respective tether and anchor portions <NUM>, <NUM>, it is to be understood that varying widths and non-linear (e.g., sinuous) cuts are also contemplated. Regardless, the anchor portion <NUM> is integrally formed with the tether portion <NUM> of the flat film construct such that the anchor portion <NUM> extends continuously from one end of the tether portion <NUM>. In one example, the anchor portion <NUM> and the tether portion <NUM> as formed have substantially the same thickness since the anchor portion <NUM> and the tether portion <NUM> are made of the same homogeneous material. Subsequent to cutting, the tether portion <NUM> may be reformed from a flat profile to have a rounder profile than the anchor portion <NUM>. As shown, there is a smooth, continuous and integral transition between the anchor portion <NUM> and the tether portion <NUM>, which may assist in reducing wearing at the transition between the two portions of the first tethered anchor <NUM>.

<FIG> shows the tether portion <NUM> in a curled, or twisted configuration (e.g., after being removed from the mandrel <NUM>). The number of turns or twists per unit length may be adjusted as desired. In some examples, the tether portion <NUM> is twisted and compressed (e.g., in a "candy cane" configuration) by drawing the tether portion <NUM> through a die configured to twist and / or compress the tether portion <NUM>. The tether portion <NUM> is optionally bonded, sintered, or otherwise formed into a more circular cross-section due to this twisting and compression process, or the like. For example, the tether portion <NUM> can be tightly curled in a compressed, twisted configuration so that the cross-section thereof is circular or ovular as indicated generally in <FIG>. Although this curling / compaction may change the overall profile of the tether portion <NUM>, as well as the density of the tether portion <NUM>, the mass of the tether portion <NUM> remains unchanged.

<FIG> shows the tethered anchor <NUM> after the tether portion <NUM> is twisted and compacted to achieve a more circular cross-section, where the tether portion <NUM> transitions smoothly into the anchor portion <NUM> which includes a plurality of crossing apertures <NUM>, such as first through fifth crossing apertures <NUM>, <NUM>, <NUM>, <NUM>, <NUM> through which the tether portion <NUM> may pass in an alternating, zig-zag or laced pattern as shown in <FIG>. The crossing apertures <NUM> may be pre-formed into the anchor portion <NUM> during manufacture (e.g., the crossing apertures <NUM> may be laser-cut when the rest of the tethered anchors <NUM> and <NUM> are cut) such that the tether portion <NUM> only needs to be guided through, extended through, or disposed therein sequentially through the crossing aperture(s) <NUM> to create an arrangement in which the end portion <NUM> may be tensioned to collapse the anchor portion <NUM> to transfer the anchor portion <NUM> from a delivery configuration to an anchoring configuration. In some examples, the anchor portion <NUM> is formed without any pre-formed crossing aperture or opening, and the crossing apertures are formed after the anchor portion <NUM> is formed by puncturing the surface of the anchor portion <NUM> to provide the openings through which the tether portion <NUM> can pass through.

Either as part of manufacture, or prior to or during implantation, a needle or other implement can be utilized to deliver end portion <NUM> through the crossing apertures <NUM> and / or to form the crossing apertures <NUM>. The size of the crossing apertures <NUM> can be the same as, smaller than, or larger than the thickness of the tether portion <NUM>. In some examples, the crossing apertures <NUM> are smaller than the thickness of the tether portion <NUM>, but the material of the anchor portion <NUM> is expandable or elastic such that the tether portion <NUM> can pass through the crossing apertures without causing damage to either the tether portion <NUM> or the anchor portion <NUM>. The crossing apertures <NUM> can be evenly spaced apart or have varied spacing. In one example, the crossing apertures <NUM> are positioned along a relatively straight line, although the crossing apertures <NUM> may be staggered or otherwise arranged. And, although <FIG> shows five crossing apertures, it is understood that any suitable number of crossing apertures can be used.

In some examples, the tether portion defines a proximal section <NUM> extending from the end portion <NUM>, a distal section <NUM> adjacent the anchor portion <NUM>, and an intermediate section <NUM> between the proximal section <NUM> and the distal section <NUM>. The proximal section <NUM>, intermediate section <NUM>, and the distal section <NUM> may make up any of a variety of percentages of the length of the tether portion <NUM>, such as <NUM>/<NUM>-<NUM>/<NUM>-<NUM>/<NUM>, <NUM>%-<NUM>%-<NUM>%, or any of a variety of combinations. In some examples, each of the sections <NUM>, <NUM>, <NUM> makes up at least <NUM>% of the length of the tether portion <NUM>.

<FIG> shows an intermediate configuration of the tethered anchor <NUM> where the end portion <NUM> is inserted through each of the crossing apertures <NUM> of the anchor portion <NUM>, and the anchor portion <NUM> is bent or folded to form a plurality of pleats <NUM>. In some examples, and as shown, the number of pleats <NUM> formed is the same as the number of crossing apertures <NUM>, such as first through fifth crossing apertures <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, on the anchor portion <NUM>. This configuration is achieved when the end portion <NUM> is brought through the first crossing aperture <NUM>, such that the anchor portion <NUM> is folded between the first crossing aperture <NUM> and the second crossing aperture <NUM> and the end portion <NUM> passes through the second crossing aperture <NUM>. These steps are repeated until end portion <NUM> passes through all the crossing apertures, as shown in <FIG>, to form a plurality of pleats <NUM> in the anchor portion <NUM>, e.g., a first pleat <NUM>, a second pleat <NUM>, a third pleat <NUM>, a fourth pleat <NUM>, and a fifth pleat <NUM>. The pleats <NUM> resemble a zigzag, or accordion shape when seen from the side. This arrangement allows the anchor portion <NUM> to initially take on an elongate, more linear profile and then upon tensioning the tether portion <NUM> the anchor portion <NUM> folds down to an enlarged, transverse profile relative to the longitudinal axis. In this manner the anchor portion <NUM> can be initially deployed in a lower profile, or delivery configuration (e.g., by being inserted through a tissue structure) and subsequently tensioned down to an enlarged profile, or anchoring configuration.

<FIG> shows the final product in an enlarged profile or anchoring configuration after the end portion <NUM> is pulled away from the anchor portion <NUM>. As shown, the pleats <NUM> are collapsed onto one another after tensioning the tether portion <NUM> to form an anchor <NUM> with a greater thickness than that of the anchor portion <NUM> in its original form shown in <FIG>.

<FIG> shows one embodiment of the end portion <NUM> of the first tether portion <NUM> as previously mentioned. In this embodiment, the end portion <NUM> has a needle <NUM> coupled to (e.g., tied onto, adhered) the end portion <NUM> such that the needle <NUM> is implemented as part of the tether portion <NUM>. In some examples, the needle <NUM> can be used for skin closure, suturing soft tissue with minimal trauma, or other microsurgical procedures. The needle <NUM> may have a pointed edge that pierces the tissue, and in some examples also may include a cutting blade edge that can cut open tissue during microsurgical procedures. The needle <NUM> may have a generally C-shaped, J-shaped, or S-shaped configuration according to some examples. Additionally, the needle <NUM> can be of any suitable shape (straight, curved, hooked, bent, twisted, etc. in some examples), size (shorter than <NUM>, between <NUM> and <NUM>, between <NUM> and <NUM>, or longer than <NUM> in length in some examples), and material (nitinol, stainless steel, or other types of metal in some examples) as appropriate for the surgical procedure.

One example of an application of the tethered anchor <NUM> as described herein is chordal repair, such as with respect to the valve chords of the heart. When valve chords are broken and the valve leaflets cannot sufficiently open and close to control the flow of blood therethrough, a tethered 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 leaflets and the other end of the tether portion to the papillary muscle, creating an artificial valve chord. As the papillary muscle contracts, the tether portion pulls the anchor portion, causing the leaflets to open and allow blood flow therethrough. In this example, the anchor portion is attached on the side of the leaflets opposite from the papillary muscle, so that when the papillary muscle contracts, the anchor portion prevents the tethered anchor from being pulled through an aperture through which the tether portion of the tethered anchor passes.

<FIG> shows one example of this application. In a healthy valve, a set of structures called chordae tendinea <NUM> connect each leaflet <NUM> to papillary muscle <NUM>. However, when the chordae tendinea are torn or ruptured, the tethered anchor <NUM> is attached to one or more of the valve leaflets <NUM> whose chordae tendinea are torn by first placing or disposing the anchor portion <NUM> against a distal surface of the valve leaflet <NUM> with respect to a papillary muscle <NUM>. Then, the anchor portion <NUM> is bent or folded over itself to form the plurality of pleats <NUM> upon tensioning of the tether portion <NUM> as shown in <FIG>. The tether portion <NUM> is passed through each of the crossing apertures <NUM> in a zigzag pattern, after which the tether portion <NUM> is tensioned to fully collapse the pleats <NUM> to form the anchor <NUM>. The end portion <NUM> of the tether portion <NUM> is subsequently attached to the papillary muscle <NUM> so the movement of the papillary muscle <NUM> induces the movement of the valve leaflet <NUM>.

Another example of an application of the tethered anchor <NUM> is in valve annuloplasty procedures in a heart, for example, where a ring around the valve in the heart (annulus) widens and changes from its normal shape. A tethered anchor <NUM> may be arranged to tighten or reinforce the annulus of the valve. This may prevent leakage of blood through the widened valve. The tethered anchor as described herein can be used such that the annuloplasty devices remain secured to the annulus and continue to assist in restoring the normal function of the valve.

Another example use of the tethered anchor <NUM> an application is in closing an opening or aperture formed in a wall of the heart, such as a ventricular or atrial septal wall defect. The tethered anchor <NUM> can be used to help close the opening from within the heart at the inner side of the heart wall, such that the flow of blood through the heart does not cause the anchor to detach from the wall through prolonged use due to the constant pressure exerted from within the heart.

In some examples, echogenicity is a factor to be considered when implementing the tethered anchor such that the anchor can be accurately captured during medical imaging such as medical ultrasonography. For example, a material is more echogenic if there is hyperechoic air implemented into the material, and the material is more capable of capturing such hyperechoic air if the material comprises a hydrophobic water-immiscible matrix. In one example, the tethered anchor is made of a hydrophobic material and/or is coated with a layer of hydrophobic agent to prevent the hyperechoic air from escaping to the environment. In another example, the tethered anchor has radiopaque fillers such as tungsten powder with a small particle size (such as less than <NUM> micron) such that the radiopaque fillers do not interfere with the function of the tethered anchor but allows for the tethered anchor to be visible under fluoroscopy or X-ray.

<FIG> and <FIG> show a tethered anchor <NUM> with a first tether portion <NUM>, or suture, a second tether portion <NUM>, and an anchor portion <NUM>, or pledget, with a plurality of crossing apertures <NUM>, in accordance with an embodiment. The anchor portion <NUM> has two ends, a first end <NUM> and a second <NUM> opposite to the first end <NUM>. The first tether portion <NUM> extends from the first end <NUM> and the second tether portion <NUM> extends from the second end <NUM> such that, when the anchor <NUM> is formed by passing the first tether portion <NUM> through the crossing apertures <NUM> as previously described, the second tether portion <NUM> extends from the anchor <NUM> as shown in <FIG>. In some examples, the second tether portion <NUM> may be used to attach an additional component to the anchor <NUM>. In some examples, the second tether portion <NUM> can extend from the same end (<NUM> or <NUM>) as the first tether portion <NUM>, as shown in <FIG>. <FIG> shows an example of the needle <NUM> in which the ends of the first tether portion <NUM> and the second tether portion <NUM> are interlocked using an interlocking mechanism <NUM> to form a parachute-like configuration. In some examples, a first needle (not shown) may be attached to a free end of the first tether portion <NUM> and a second needle (not shown) may be attached to a free end of the second tether portion <NUM>, where the free end is the end of the tether portion that is not attached or connected to the anchor portion <NUM>. These needles may be the needle <NUM> as explained above and shown in <FIG>. In some examples, the two needles are different from each other, such as having different shapes, sizes, and/or materials.

<FIG> show a pair of tethered anchors <NUM> and <NUM> connected to each other via an interlocking mechanism <NUM>. The first tethered anchor <NUM> has the first tether portion <NUM> extending from the first anchor portion <NUM> and a second tethered anchor <NUM> has the second tether portion <NUM> extending from a second anchor portion <NUM>. The ends of the two tether portions <NUM> and <NUM> can be interlocked using the interlocking mechanism <NUM> such that the two tethered anchors <NUM> and <NUM> can essentially be utilized as a single continuous tether with an anchor <NUM> or <NUM> on each end, as shown in <FIG>.

In this case, the anchors <NUM> and <NUM> are located on two opposing sides of two walls <NUM> and <NUM>, and the interlocking mechanism <NUM> is disposed in a space between the walls <NUM> and <NUM> separated from the two anchors <NUM> and <NUM>. The anchors <NUM> and <NUM> are formed before the two tether portions <NUM> and <NUM> become interlocked. Initially, the first anchor <NUM> is formed by inserting the tether portion <NUM> through the crossing apertures <NUM> as previously described, and the second anchor <NUM> is similarly formed by inserting the second tether portion <NUM> through crossing apertures <NUM> of the second anchor portion <NUM>. Then, the two free ends of the tether portions <NUM> and <NUM> are coupled together using the interlocking mechanism <NUM>.

In some examples, the interlocking mechanisms <NUM> and <NUM> may be clamps, clips, locks, latches, or any suitable mechanism to secure the two tether portions <NUM> and <NUM> (in <FIG>) or <NUM> (in <FIG>) together. In some examples, the interlocking mechanisms <NUM> and <NUM> also have a tightening capability which can adjust the length of the tether formed by interlocking the two tether portions <NUM> and <NUM> or <NUM>. For example, there may be a screw or knob on the interlocking mechanism <NUM> which, when activated, brings the two anchors <NUM> and <NUM> closer together.

<FIG> show an anchor portion <NUM> with a first row of crossing apertures <NUM> located in a first section <NUM> of the anchor portion <NUM> and a second row of crossing apertures <NUM> located in a second section <NUM> of the anchor portion <NUM>, in accordance with an embodiment. The tether portion <NUM> extends from the anchor portion <NUM> at the first section <NUM>, the second portion <NUM>, or therebetween. The anchor portion <NUM> can be folded along the broken line as shown in <FIG>. The first row of crossing apertures <NUM> align with the second row of crossing apertures <NUM> when the anchor portion <NUM> is folded. After folding the anchor portion <NUM>, the tether portion <NUM> crosses each of the first and second rows of crossing apertures <NUM> as shown in <FIG> to maintain the orientation of the first and second sections <NUM> and <NUM> of the anchor portion <NUM>. Applying a force on the tether portion <NUM> directed away from the anchor portion <NUM> causes the folded anchor portion <NUM> to collapse, similar to the example shown in <FIG>, after which the anchor portion <NUM> becomes a folded anchor (not shown).

<FIG> show an anchor portion <NUM> with a first row of crossing apertures <NUM> located in a first section <NUM> of the anchor portion <NUM>, a second row of crossing apertures <NUM> located in a second section <NUM> of the anchor portion <NUM>, and a third row of crossing apertures <NUM> located on a third section <NUM> of the anchor portion <NUM>, in accordance with an embodiment. Similar to the anchor portion <NUM>, the anchor portion <NUM> is foldable along the broken lines, where the first, second, and third rows of crossing apertures <NUM>, <NUM>, <NUM> overlap with each other in the folded configuration, during which the tether portion <NUM>, which may extend from any one of the three sections <NUM>, <NUM>, <NUM> or therebetween. <FIG> shows the anchor portion <NUM> being folded in a trifold or "letter-fold" configuration (e.g., resembling how a letter would be folded prior to being placed inside an envelope). Applying a force on the tether portion <NUM> as previously explained collapses the folded anchor portion <NUM> into a folded anchor (not shown). It should be understood that any other number of sections (for example, four or greater), may be used as appropriate, depending on the thickness of the anchor portion that is being folded to form the anchor.

<FIG> show a cross-shaped anchor portion <NUM> with five sections or pleats <NUM>, <NUM>, <NUM>, <NUM>, <NUM> and five crossing apertures <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, respectively, located at or proximate the center of each section. In some examples, each pleat <NUM>, <NUM>, <NUM>, <NUM>, <NUM> may be substantially square in shape, with each side of the outer periphery of the cross-shaped anchor portion <NUM> being equal or similar in length. The tether portion <NUM> may extend from any one of the five pleats <NUM>, <NUM>, <NUM>, <NUM>, <NUM>. <FIG> shows an example of how the anchor portion <NUM> can be folded along the broken lines shown in <FIG> shows an anchor portion <NUM> that results from folding the anchor portion <NUM> and having the tether portion <NUM> pass through the crossing apertures <NUM>, <NUM>, <NUM>, <NUM>, <NUM> which align with each other in the folded configuration. Advantages in increasing the number of foldable elements as shown in <FIG> include being able to adjust the thickness of the anchor that results from folding the anchor portion(s) and passing a tether therethrough. The increased thickness can also increase the stability and durability of the anchors in some examples.

<FIG> shows a tethered anchor <NUM> according to another embodiment which includes a plurality of anchor portions <NUM>, <NUM>, <NUM>, and <NUM>. Although <FIG> shows four anchor portions, any suitable number of anchor portions can be implemented in other examples. Each pair of neighboring anchor portions is connected with a connecting member such that anchor portions <NUM> and <NUM> are connected with a connecting member <NUM>, anchor portions <NUM> and <NUM> are connected with a connecting member <NUM> and anchor portions <NUM> and <NUM> are connected with a connecting member <NUM>. Similar to the previously mentioned embodiments, the anchor portions <NUM>, <NUM>, <NUM>, and <NUM> fold onto one another to form an anchor similar to the anchor <NUM> in <FIG>.

<FIG> show two configurations of a stop component coupled to the tether portion <NUM> to prevent the tether portion <NUM> from passing through the anchor portion <NUM> or the crossing apertures <NUM> located in the anchor portion <NUM>. In <FIG>, a stop component <NUM> may be coupled to the tether portion <NUM> or at a junction between the anchor portion <NUM> and the tether portion <NUM>. The stop component <NUM> may take the form of a knot, a swaged structure, a crimped structure, or any other suitable structure that limits the ability of the tether portion <NUM> to pass through the anchor portion <NUM> or the crossing apertures <NUM>. For example, the diameter of at least a portion of the stop component <NUM> can be wider than the crossing apertures <NUM>. In <FIG>, a swaged stopper <NUM> that has a T-shaped cross section may be coupled to the tether portion <NUM>. The stop component <NUM> and the swaged stopper <NUM> may have any suitable shape and cross section, and be composed of any suitable material such as metal, rubber, silicone, as well as other elastic or plastic polymers, for example.

<FIG> shows end portions of a tethered anchor <NUM> and needles <NUM> arranged at each of the ends according to some embodiments. As shown, each of the end portions <NUM> of the tethered anchor <NUM> include needles <NUM> coupled to the end portion <NUM> of tether portion <NUM> the tethered anchor <NUM>. A tether portion <NUM>, as described in detail above, may be attached or coupled to distal portion <NUM> of the tether portion <NUM>. The dual needled tethered anchor <NUM> can be used in numerous procedures such as skin closure, suturing soft tissue with minimal trauma, or other microsurgical procedures, cardiac valve repair, or other similar procedures. In certain instances, one or both of the needles may be replaced with a tissue anchor as shown and described with reference to <FIG>.

<FIG> shows an end portion of a tethered anchor <NUM> and a tissue anchor <NUM> arranged at the end portion according to some embodiments. As shown, the tissue anchor <NUM> is coupled to an end portion <NUM> of the tethered anchor <NUM>. The tissue anchor <NUM> may be coupled to the end portion <NUM> of the tether portion <NUM> such that the tissue anchor <NUM> is implemented into the end portion <NUM> as part of the tethered anchor <NUM>. In certain instances, the tissue anchor <NUM> is attached, or adhered to the end portion <NUM>. As shown in <FIG>, the tissue anchor <NUM> may be coupled to both ends of a tethered anchor <NUM>. In addition, more than one tissue anchor <NUM> may be arranged with the both ends of a tethered anchor <NUM> or along the tethered anchor <NUM>.

As shown in <FIG>, the tissue anchor <NUM> includes a helical shape. The tissue anchor <NUM> may have one or more coils, as is shown. The number of turns or coils of the tissue anchor <NUM> can be varied in order to lengthen or shorten the depth at which the tissue anchor <NUM> may be arranged within a leaflet or tissue. The tissue anchor <NUM> may be coupled to one or both ends of the tether portion <NUM> as discussed in detailed above with reference to <FIG>.

<FIG> shows an end portion of a tethered anchor <NUM> and a tissue anchor <NUM> arranged at the end portion according to some embodiments. As shown, the tissue anchor <NUM> is coupled to an end portion <NUM> of the tethered anchor <NUM>. The tissue anchor <NUM> may be threaded onto or adhered to the end portion <NUM> of the tether portion <NUM> such that the tissue anchor <NUM> is implemented into the end portion <NUM> as part of the tethered anchor <NUM>. As shown in <FIG>, the tissue anchor <NUM> may be coupled to both ends of a tethered anchor <NUM>.

As shown in <FIG>, the tissue anchor <NUM> includes multiple barbs that are configured to embed within tissue. The tissue anchor <NUM> may include three, four, five, six, or any additional number of barbs to facilitate anchoring within tissue. The tissue anchor <NUM> may be coupled to one or both ends of the tether portion <NUM> as discussed in detailed above with reference to <FIG>. In addition, more than one tissue anchor <NUM> may be arranged with the both ends of a tethered anchor <NUM> or along the tethered anchor <NUM>.

Claim 1:
A tethered anchor (<NUM>;<NUM>) for medical procedures, comprising:
a tether portion (<NUM>;<NUM>) that is elongate and extends between a first end (<NUM>) and a second end (<NUM>) of the tether portion, the tether portion (<NUM>;<NUM>) being formed of a flat film construct; and
an anchor portion (<NUM>;<NUM>) that defines a width that is greater than a width of the tether portion (<NUM>;<NUM>), the anchor portion (<NUM>;<NUM>) being integrally formed with the tether portion (<NUM>;<NUM>) of the flat film construct and extending continuously from the second end of the tether portion, the anchor portion having a plurality of apertures (<NUM>) through which the tether portion (<NUM>;<NUM>) extends, such that the anchor portion defines one or more pleats (<NUM>) upon tensioning of the tether portion