Anchor for mitral valve chordae repair

Abstract

Aspects of the present disclosure relate to devices, systems, and methods including tissue anchors, such as for chordae tendineae repair.

Description

This application is a divisional application of Chinese invention patent application No. 202080066851.X, which is a Chinese national phase application of international application No. PCT / US2020 / 052163 filed on March 23, 2022 and entitled “Anchor for Mitral Valve Chordal Repair”. CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of Provisional Patent Application No. 62 / 904,327, filed September 23, 2019, which is incorporated herein by reference in its entirety for all purposes. Technical Field

[0002] The present disclosure generally relates to apparatus, systems and methods including anchors for medical devices. More specifically, the present disclosure relates to apparatus, systems and methods including anchors for chordal repair. Technical Field

[0003] The leaflets of the atrioventricular valves (mitral and tricuspid) are thin, translucent structures that rely on a system of long, thin, cord-like supports to maintain valve function under load. These supports, the chordae tendineae, attach the papillary muscles to the valve leaflets.

[0004] The chordae tendineae can degenerate and stretch, which can lead to leaflet prolapse. As a result, under systolic loads, the leaflet(s) can become misaligned. Open surgical procedures for the chordae tendineae are highly invasive and are associated with a high risk of morbidity and mortality. Therefore, in chordae tendineae replacement or repair, delivery and implantation of artificial chordae tendineae (one or more) without the use of an open surgical procedure (or transapical or transatrial delivery approaches) can reduce the risk of morbidity and mortality. Summary of the invention

[0005] According to one example ("Example 1"), a tubular member having a proximal end and a distal end; at least one wire is arranged to pass through the tubular member to form: a plurality of anchor portions extending from the distal end of the tubular member, each anchor portion defining a curve extending in a direction toward the proximal end, and an eyelet extending from the proximal end; and a tissue puncturing element extending from the proximal end of the tubular member and arranged near the plurality of anchor portions.

[0006] According to another example ("Example 2") further than the tissue anchor of Example 1, the at least one wire includes at least two wires disposed through the tubular member, and the at least two wires overlap to form the eyelet.

[0007] According to another example ("Example 3") further than the tissue anchor of Example 2, at least two wires form a plurality of anchors, and the plurality of anchors includes at least four anchors.

[0008] According to another example ("Example 4") further to the tissue anchor of any of Examples 1-2, the tubular member includes a plurality of lumens extending between the proximal end and the distal end, and the lumens are configured to maintain the arrangement of at least one wire.

[0009] According to another example ("Example 5") that is further than the tissue anchor of any of Examples 1-4, the tissue piercing element includes a longitudinal portion and a depth indicator configured to provide tactile feedback to a physician embedding the plurality of anchors into tissue.

[0010] According to another example ("Example 6") that is further than the tissue anchor of Example 5, the depth indicator includes a spacer and a biasing member arranged around a longitudinal portion of the tissue piercing element, the spacer being configured to contact the tissue and push the biasing member toward the distal end of the tubular member to an extent configured to indicate the extent to which multiple anchor portions extend within the tissue.

[0011] According to another example ("Example 7") further to the tissue anchor of any of Examples 1-6, the tubular member includes at least one of PEEK and stainless steel.

[0012] According to another example ("Example 8") further to the tissue anchor of any of Examples 1-7, the tissue anchor also includes a flexible cord arranged to pass through the eyelet for coupling the tissue anchor to the tissue.

[0013] According to another example ("Example 9") that is further than the tissue anchor of any one of Examples 1-8, the tissue anchor also includes a position feedback mechanism disposed at the distal end of the tubular member and configured to indicate a slope or angle of the tissue wall.

[0014] According to another example ("Example 10"), a tissue anchor includes at least one wire configured to form: an upper circular portion configured to interface with a flexible rope; one or more tissue piercing elements configured to engage a tissue surface and move between a first configuration and a second configuration, in which the one or more tissue piercing elements are configured to be substantially parallel to the tissue surface and in which the one or more tissue piercing elements are configured to be non-parallel to the tissue surface; and a middle portion configured to move the one or more tissue piercing elements from the first configuration to the second configuration in response to a reduction in diameter of the middle portion.

[0015] According to another example ("Example 11") further than the tissue anchor of Example 10, the shape of the middle portion is substantially elliptical.

[0016] According to another example ("Example 12") further than the tissue anchor of any of Examples 10-11, at least one wire includes a second circular portion, and the one or more tissue-piercing elements extend from the second circular portion.

[0017] According to another example ("Example 13") that is further than the tissue anchor of any of Examples 10-12, the tissue anchor also includes a delivery sheath, which is configured to reduce the diameter of the middle portion and release the constraints on the middle portion, thereby allowing one or more tissue piercing elements to move from a first structure to a second structure.

[0018] According to another example ("Example 14") further to the tissue anchor of Example 13, one or more tissue-piercing elements are configured to clamp the tissue surface in response to movement from the first configuration to the second configuration.

[0019] According to another example ("Example 15") that is further relative to the tissue anchor of any of Examples 10-14, the flexible tether is configured for coupling the tissue anchor to tissue.

[0020] According to one example ("Example 16"), a tissue anchor includes a cylindrical portion having a longitudinal axis, a proximal end and a distal end; and a plurality of anchor portions configured to fix the cylindrical portion below a tissue surface, each of the plurality of anchor portions comprising: a substantially linear segment extending from the distal end of the cylindrical portion parallel to the longitudinal axis, and a curved segment extending from the substantially linear segment and configured to be aligned with the substantially linear segment relative to the longitudinal axis in a delivery configuration, and to bend radially outward relative to the longitudinal axis and toward the distal end of the cylindrical portion in a deployed configuration.

[0021] According to another example ("Example 17") further than the tissue anchor of Example 16, the cylindrical portion includes one or more notches in an outer surface of the cylindrical portion.

[0022] According to another example ("Example 18") that is further than the tissue anchor of Example 17, one or more notches are configured to facilitate flexibility of the cylindrical portion.

[0023] According to another example ("Example 19") that is further than the tissue anchor of any of Examples 16-18, the tissue anchor also includes a flexible rope arranged to pass through the opening in the cylindrical portion, the flexible rope being configured to couple the tissue anchor to tissue.

[0024] According to another example ("Example 20") further than the tissue anchor of Example 19, the cylindrical portion includes an adjustment mechanism configured to adjust the length of the flexible cord.

[0025] According to one example ("Example 21"), a tissue anchor includes a first anchoring segment, which includes a first curved segment and a first tissue piercing element extending longitudinally from the inner surface of the apex of the first curved segment; a second anchoring segment, which includes a second curved segment and a second tissue piercing element extending longitudinally from the inner surface of the apex of the second curved segment; a first transition segment, which is arranged in a first plane between the first anchoring segment and the second anchoring segment and extends perpendicular to the first anchoring segment and the second anchoring segment; and a second transition segment, which is arranged in a second plane between the first anchoring segment and the second anchoring segment and extends perpendicular to the first anchoring segment and the second anchoring segment.

[0026] According to another example (“Example 22”) further than Example 21, the first plane and the second plane are spaced apart from each other.

[0027] According to another example ("Example 23") further than the tissue anchor of any of Examples 21-22, at least one of the first transition segment and the second transition segment defines a curve.

[0028] According to another example ("Example 24") that is further than the tissue anchor of any of Examples 21-23, the first anchoring segment, the second anchoring segment, the first transition segment, and the second segment are configured to be deployed into a substantially common plane.

[0029] According to another example ("Example 25") that is further than the tissue anchor of any one of Examples 21-24, the tissue anchor also includes a flexible rope connected to at least one of the first anchoring segment, the second anchoring segment, the first transition segment and the second transition segment for connecting the tissue anchor to the tissue.

[0030] According to one example ("Example 26"), a tissue anchor includes: a cylindrical portion having an inner cavity, a proximal end, and a distal end; a plurality of anchor portions extending from the inner cavity and radially outward relative to an outer surface of the cylindrical portion; a ball disposed at or near the distal end of the cylindrical portion; and a flexible rope extending within the inner cavity of the cylindrical portion and connected to the ball, the flexible rope being configured to withdraw the ball toward the proximal end and engage the plurality of anchor portions to change the configuration of the plurality of anchor portions.

[0031] According to another example ("Example 27") that is further than the tissue anchor of Example 26, the ball is configured to be at least partially withdrawn into the lumen to change the configuration of the plurality of anchoring portions.

[0032] According to one example ("Example 28"), a tissue anchor includes: a cylindrical portion having a proximal end and a distal end; and an anchoring element configured to fix the cylindrical portion to a tissue surface or below a tissue surface, the anchoring element having a helical structure having a proximal end disposed at the distal end of the cylindrical portion and including a plurality of rings whose diameters increase from the proximal end of the helical structure to the distal end of the helical structure.

[0033] According to another example ("Example 29") further than the tissue anchor of Example 28, the tissue anchor also includes one or more barbs disposed on an outer surface of the helical structure.

[0034] According to another example ("Example 30") that is further relative to the tissue anchor of any of Examples 28-29, the tissue anchor also includes a flexible cord coupled to the cylindrical portion, the flexible cord being configured to couple the tissue anchor to tissue.

[0035] According to one example ("Example 31"), a tissue anchor includes a cylindrical portion having a proximal end and a distal end; a plurality of substantially linear segments extending from the distal end of the cylindrical portion; and a plurality of helical anchor portions disposed at the distal end of each of the plurality of substantially linear segments and configured to secure the cylindrical portion to a tissue wall.

[0036] According to another example ("Example 32") further than the tissue anchor of Example 31, the tissue anchor also includes a flexible cord coupled to the cylindrical portion, the flexible cord being configured to couple the tissue anchor to tissue.

[0037] According to one example ("Example 33"), a method for chord repair includes: setting a flexible rope to pass through a leaflet and anchoring a first end of the flexible rope to the leaflet; connecting a second end of the flexible rope to a tissue anchor; and anchoring the tissue anchor as described in any of Examples 1-32 to heart tissue.

[0038] The foregoing examples are merely examples and should not be construed as limiting or otherwise narrowing the scope of any inventive concept otherwise provided by the present disclosure. Although a number of examples are disclosed, other examples will become apparent to those skilled in the art from the following detailed description, which illustrates and describes illustrative examples of the present invention. Therefore, the drawings and detailed description should be considered illustrative in nature and not restrictive in nature. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] 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.

[0040] Figure 1 is an illustration of a patient's heart and chordae tendineae according to an embodiment.

[0041] Figure 2 is an illustration of an exemplary chord repair device according to an embodiment.

[0042] Figure 3A is a first perspective view of an illustration of an exemplary tissue anchor according to an embodiment.

[0043] Figure 3B According to an embodiment Figure 3A A second stereoscopic view of a tissue anchor is shown in FIG.

[0044] Figure 3C According to an embodiment Figure 3A-3B A third stereoscopic view of a tissue anchor is shown in FIG.

[0045] Figure 4A is a side view of an illustration of another exemplary tissue anchor according to an embodiment.

[0046] Figure 4B is in a delivery configuration according to one embodiment Figure 4A Illustration of the tissue anchor shown in .

[0047] Figure 4C is in an expanded configuration according to an embodiment Figures 4A-4B Illustration of the tissue anchor shown in .

[0048] Figure 5 is a first perspective view of an illustration of an exemplary tissue anchor according to an embodiment.

[0049] Fig. 6A is an illustration of an exemplary tissue anchor in a deployed configuration according to an embodiment.

[0050] Figure 6B is in a delivery configuration according to one embodiment Fig. 6A Illustration of the tissue anchor shown in .

[0051] Figure 6C A flexible rope pivot according to an embodiment Figure 6A-6B Illustration of the tissue anchor shown in .

[0052] Fig.6D According to an embodiment of the present invention, there is a regulating mechanism Figures 6A-6C Illustration of the tissue anchor shown in .

[0053] Fig. 7A is a perspective view of a diagram of another exemplary tissue anchor according to an embodiment.

[0054] Figure 7B According to one embodiment, a needle is provided Fig. 7A A stereoscopic view of a tissue anchor is shown in FIG.

[0055] Figure 7C According to an embodiment Figure 7A-7B An expanded view of the tissue anchor is shown in FIG.

[0056] Fig. 8A is an illustration of a tissue anchor in a delivery configuration, in a first configuration, according to an embodiment.

[0057] Figure 8B According to an embodiment, the second configuration Fig. 8A Illustration of the tissue anchor shown in .

[0058] Figure 8C According to an embodiment Figures 8A-8B Illustration of a cutting pattern for a portion of a tissue anchor shown in .

[0059] Fig. 9A is a perspective view of a diagram of another exemplary tissue anchor according to an embodiment.

[0060] Fig. 9B According to one embodiment, a Fig. 9A A perspective view of a portion of a tissue anchor is shown in FIG.

[0061] Fig.10 is a perspective view of a diagram of another exemplary tissue anchor according to an embodiment.

[0062] Fig.11 is an illustration of an exemplary cutting pattern for a tissue anchor according to an embodiment.

[0063] Fig. 12A is a side view of an exemplary tubular member for use with a tissue anchor according to an embodiment.

[0064] Fig. 12B According to an embodiment Fig. 12A A proximal end view of the tubular member shown in FIG.

[0065] Fig. 12C According to an embodiment Figures 12A-12B A distal end view of the tubular member is shown in FIG.

[0066] Fig.12D According to an embodiment Figures 12A-12C 0046] A side view of another exemplary configuration of a tubular member is shown in FIG.

[0067] Fig.13A is a proximal end view of an exemplary tubular member and at least one wire disposed through the tubular member according to an embodiment.

[0068] Fig. 13B According to an embodiment Fig.13A A proximal end view of another arrangement of a tubular member and at least one wire arranged to pass through the tubular member is shown in FIG.

[0069] Fig.14A is a side view of an exemplary tissue anchor and depth indicator according to an embodiment.

[0070] Fig. 14B According to an embodiment Fig.14A A side view of a tissue anchor and another depth indicator is shown in FIG.

[0071] Fig.15A is a distal end view of an exemplary tubular member and position feedback mechanism according to one embodiment.

[0072] Fig. 15B According to one embodiment, the tissue wall is joined Fig.15A A view of the tubular member and position feedback mechanism shown in FIG. DETAILED DESCRIPTION Definitions and terminology

[0073] This specification is not intended to be read in a limiting manner. For example, the terms used in this specification should be read broadly in the context of the meanings that those skilled in the art would attribute to such terms.

[0074] Regarding imprecise terms, the terms "about" and "approximately" are used interchangeably to refer to measurements including the measured values ​​and also any measurements that are reasonably (fairly) close to the measured values. As understood and easily determined by a person of ordinary skill in the relevant art, a measurement that is reasonably close to the measured value deviates from the measured value by a reasonably small amount. Such deviations may be attributed to, for example, measurement errors, differences in calibration of the measured values ​​and / or manufacturing equipment, human errors in reading and / or setting the measured values, fine-tuning to optimize performance and / or structural parameters in view of differences in the measured values ​​associated with other components, specific implementation scenarios, imprecise adjustments and / or manipulations of objects by humans or machines, and / or the like. In the case where it is determined that a person of ordinary skill in the relevant art will not quickly determine such a reasonably small difference value, the terms "about" and "approximately" may be understood as the value plus or minus 10%.

[0075] Certain terms are used herein for convenience only. For example, words such as "top," "bottom," "up," "down," "left," "right," "horizontal," "vertical," "upward," and "downward" describe only the configurations shown in the figures. In practice, the referenced components may be oriented in any direction. Similarly, throughout this disclosure, if a process or method is shown or described, the method may be performed in any order or simultaneously unless it is clear from the context that the method depends on certain operations being performed first. Description of various embodiments

[0076] Those skilled in the art will readily appreciate that various aspects of the present disclosure may be implemented by any number of methods and devices configured to perform the intended functions. It should also be noted that the drawings referenced herein are not necessarily drawn to scale, but may be exaggerated to illustrate various aspects of the present disclosure, and in this regard, the drawings should not be construed as limiting.

[0077] Applications of the methods, systems, and devices discussed herein may involve providing artificial chords comprising flexible (rope) cables. The artificial chords may be configured to attach to one or more leaflets and / or other cardiac structures, such as one or more heart walls (e.g., the septum or other chamber walls), papillary muscles, or other structures. In some applications, the valve undergoing repair may be a mitral valve or a tricuspid valve. In various examples, the flexible cord is coupled to one or more leaflets at an upper end and to a papillary muscle, a ventricular wall, or other structure at a lower end. One or both ends of the flexible cord may include an anchor for coupling the flexible cord between cardiac structures. Although various embodiments are described in conjunction with chord applications, it should be understood that the operating principles and associated features and concepts specifically contemplated may be applicable to any tissue anchoring application as desired.

[0078] Figure 1 is an illustration of a patient's heart 100 and chordae tendineae 102a - g , according to one embodiment. Figure 1 The left side of a patient's heart 100 is shown, including an aortic arch 104, a left atrium 106, a left ventricle 108, with the mitral valve located between the left atrium 106 and the left ventricle 108. Chordae tendineae 102a-g are attached to leaflets 110 of the mitral valve at one end and to papillary muscles 112 of the left ventricle 108 at the other end.

[0079] Stretched, ruptured or broken chordae tendineae 102a-g may alter the function of the mitral valve leaflets 110. For example, in these cases, the mitral valve may no longer close or close completely. As a result, blood may flow from the left ventricle 108 back into the left atrium 106 (e.g., mitral regurgitation).

[0080] Figure 2is an illustration of an exemplary anchoring device 200 according to an embodiment. In some cases, the anchoring device 200 may include: a flexible cord 202; a first attachment member 204 disposed at one end of the flexible cord 202; and a second attachment member 206 disposed at the other end of the flexible cord 202. As described above, the anchoring device 200 may be used for chordae tendineae treatment. In other cases, the anchoring device 200 may be used for tissue anchoring.

[0081] According to various examples, the flexible cord 202 is biocompatible and may be made of one or more of the following materials, such as, but not limited to, polypropylene, nylon (polyamide), polyester, polyvinylidene fluoride (PVDF, polyvinylidenefluoride or polyvinylidene difluoride), silk, or the flexible cord 202 is primarily formed of a fluoropolymer, including, but not limited to, polytetrafluoroethylene (PTFE) or expanded polytetrafluoroethylene (ePTFE), as well as other suitable materials. The flexible cord 202 may be formed of a suture material, including, but not limited to, monofilament sutures, multifilament and / or braided structures, and woven and non-woven materials. In some examples, the flexible cord 202 is made of a fluoropolymer-based suture material, such as that used for chordal tendon ("CT") therapy. Suture-Related Materials. Although synthetic materials are contemplated according to various embodiments, in some examples, the flexible cord 202 may also include natural materials, such as, but not limited to, human or other animal tissue or plant-based materials.

[0082] The first attachment member 204 and the second attachment member 206 are configured to attach the flexible cord 202 to the tissue of the heart. The first attachment member 204 and the second attachment member 206 can be anchors that pierce the tissue and hold the flexible cord 202 between the first position and the second position, wherein the first attachment member 204 and the second attachment member 206 pierce the tissue at the first position and the second position, respectively, and remain within the tissue or at the surface of the tissue. The first attachment member 204 and the second attachment member 206 can include barbs, fixation spirals, hooks, forks, or any similar structure.

[0083] In some cases, the flexible cord 202 can be used to treat a defective mitral or tricuspid valve. In these cases, a catheter-based device is percutaneously introduced into the apical region of the heart. By replacing at least one chordae tendineae (e.g., Figure 1The chordae tendineae 202 may be replaced by a flexible cord 202, which may also be referred to as a tissue connector because the flexible cord 202 connects two portions of heart tissue. In other cases, the flexible cord 202 may be wrapped around the periphery of the heart, or the annulus may be disposed within the leaflets or tissue. In these cases, the flexible cord 202 slightly compresses one or more structures of the heart to ensure that the leaflets of the valve are completely closed.

[0084] As mentioned, the flexible cord 202 can be supplied with one or more anchors or attachment mechanisms. In some examples, the flexible cord 202 is supplied with one or more swab anchors, for example made of a fluoropolymer such as ePTFE or any material described in association with the flexible cord 202. Such a swab anchor can be supplied with pre-punched holes or other features (portions) and can be used to anchor to one or more leaflets or other cardiac structures. Such anchors may primarily include designs such as hooks, spirals, or barbs. In some examples, the flexible cord 202 is supplied with a self-expanding (e.g., such as but not limited to Nitinol (NiTi)) anchor, as described in detail below, which is configured to assist in anchoring to a cardiac structure, such as a papillary muscle or a ventricular wall. For example, the anchor can be a shaped NiTi with multiple (branch) leg members that are displaced from the central tube to resist movement.

[0085] Figure 3A 30 is a first perspective view of an illustration of an exemplary tissue anchor 300 according to an embodiment. The tissue anchor 300 includes a tubular member 303 having a proximal end 304 and a distal end 306. The tissue anchor 300 also includes at least one wire 308a, 308b disposed to pass through the tubular member 303. In some cases, the at least one wire 308a, 308b includes two wires 308a, 308b. In other cases, the at least one wire 308a, 308b includes a single wire that passes through the tubular member 303 to form a loop. In still other cases, the at least one wire 308a, 308b includes three, four, five, six or more wires. In some cases, the tubular member 303 is formed of a biocompatible material, such as, but not limited to, polyetheretherketone (PEEK), stainless steel, or a combination thereof.

[0086] At least one wire 308a, 308b is configured as a plurality of anchor portions 310a-d extending from the distal end 306 of the tubular member 306, such as Figure 3B-Figure 3CAs shown in more detail in . As shown, the plurality of anchoring portions 310a-d includes four anchoring portions. In some cases, the plurality of anchoring portions 310a-d includes two, three, five, six or more anchoring portions 310a-d. As shown, the plurality of anchoring portions 310a-d includes a curve that extends the plurality of anchoring portions 310a-d toward the proximal end 304 of the tubular member 303. In some cases, at least one wire 308a, 308b includes two wires 308a, 308b and the plurality of anchoring portions 310a-d includes at least four anchoring portions 310a-d. As discussed herein, the wire may include a monofilament, a strut, a multifilament, a braided strand or other similar structures. In some cases, the tubular member 303 includes a plurality of lumens (such as Figure 12A-12C and Figure 13A-13B In addition, the inner cavity is configured to maintain the arrangement of at least one wire 308a, 308b.

[0087] At least one wire 308a, 308b may also form an eyelet 312. The eyelet extends outwardly from the proximal end 304. In some cases, as described in detail above, a flexible cord may be configured to pass through the eyelet 312 for chordal therapy. In some cases, at least one wire 308a, 308b is configured to overlap to form the eyelet 312.

[0088] like Figure 3A and Figure 3C As shown, include curved portions 314a, 314b, these curved portions make at least one wire 308a, 308b extend outward relative to the proximal end 304 of the tubular member 303 and extend backward toward the proximal end 304 of the tubular member 303. In some cases, at least one wire 308a, 308b includes two wires 308a, 308b and each of the wires 308a, 308b forms one of the curved portions 314a, 314b. In addition, the curved portions 314a, 314b can be arranged to be substantially perpendicular to each other. Further, as shown, one of the curved portions 314a, 314b can be arranged above the other of the curved portions 314a, 314b (e.g., farther from the proximal end 304 of the tubular member 303).

[0089] In some cases, such as Figure 3B As shown, the tissue anchor 300 also includes a tissue piercing element 316 extending from the proximal end 304 of the tubular member 303. The tissue piercing element 316 can be disposed between the plurality of anchoring portions 310a-d. In some cases, the tissue piercing element 316 includes a penetration tip 318. The penetration tip 318 can also be configured to anchor within the tissue. In addition, the penetration tip 318 can be spiral (e.g., as described in more detail below).

[0090] In some cases, tissue-piercing element 316 includes a longitudinal portion 320 and a depth indicator 322 configured to indicate to a physician that multiple anchors 310a-d are embedded in tissue. Depth indicator 322 may include a spacer such as a washer and a biasing member such as a spring wrapped around longitudinal portion 320 (e.g., Figure 3A ). The spacer can be configured to contact the tissue and force the biasing member toward the distal end 306 of the tubular member 303 to indicate the plurality of anchors 310a-d within the tissue. In some cases, the tissue anchor 300 can be disposed within a delivery sheath (e.g., as shown in FIG. Figure 4B ) for deployment. The tissue-piercing element 316 can be forced into the tissue, and the biasing member and depth indicator 322 can provide tactile feedback to the clinician. Figure 3A-3C The tissue anchor 300 shown in is discussed as being formed from one or more wires 308, but the anchors 310a-d can also be formed from a cut tube pattern (form) or a cut sheet of material.

[0091] Figure 4A 300 according to an embodiment. The tissue anchor 300 includes at least one wire 308. The at least one wire includes a first circular portion 424, a middle portion 426, and one or more tissue piercing elements 316a, 316b.

[0092] As described in detail above, the first circular portion 424 can be configured to interface with the flexible cord 202 for chordae tendineae therapy. In addition, one or more tissue piercing elements 316a, 316b are configured to engage the tissue surface 450 and Figure 4A The first configuration shown and Figure 4B In the first configuration, one or more tissue piercing elements 316a, 316b may be disposed substantially parallel to tissue surface 450 (e.g., in a non-anchored configuration). In the second configuration, one or more tissue piercing elements 316a, 316b may be disposed non-parallel to tissue surface 450.

[0093] The middle portion 426 is configured to move one or more tissue-piercing elements 316a, 316b from a first configuration to a second configuration in response to a decrease in the diameter of the middle portion 426. In some cases, the middle portion 426 is substantially elliptical in shape, such as Figure 4A As shown. Figure 4BAs shown, the middle portion 426 can be configured to reduce its diameter by being disposed within a delivery sheath 452. The delivery sheath 452 is configured to accommodate the tissue anchor 300. The delivery sheath 452 is configured to reduce the diameter of the middle portion 426 and release the constraint on the middle portion to allow one or more tissue piercing elements 316a, 316b to move from a first configuration to a second configuration.

[0094] The reduction in diameter of the middle portion 426 causes one or more tissue-piercing elements 316a, 316b to move from a non-engaged configuration (eg, substantially parallel to the long axis of the middle portion 426) to a position such as Figure 4B The one or more tissue piercing elements 316a, 316b are configured to clamp the tissue surface 450 in response to movement from the first configuration to the second configuration. The one or more tissue piercing elements 316a, 316b can pierce the tissue surface 450 to secure the tissue anchor 300 in place. Figure 4C As shown, one or more tissue piercing elements 316a, 316b remain in tissue surface 450 after removal of tissue surface 450. When engaged, middle portion 426 moves back toward a substantially elliptical or rectangular (oblong) shape. Tissue piercing elements 316a, 316b remain non-parallel to tissue surface 450.

[0095] In addition, at least one wire 308 includes a second circular portion 456, such as Figure 4A As shown, tissue piercing elements 316a, 316b extend from second circular portion 456. In the second engagement configuration, tissue piercing elements 316a, 316b are separated and second circular portion 456 expands outwardly, as shown. Figure 4C shown.

[0096] Figure 5 is a first stereoscopic view of an illustration of an exemplary tissue anchor 300 according to one embodiment. The tissue anchor 300 includes a tubular member 303 having a proximal end 304 and a distal end 306. The tissue anchor 300 also includes one or more wires 308 disposed to pass through the tubular member 303. The tissue anchor 300 also includes a plurality of anchor portions 310a-e. In some cases, the number of wires 308 is equal to the number of anchor portions 310a-e. In other cases, the number of wires 308 is half the number of anchor portions 310a-e, wherein each wire is disposed to pass through the tubular member 303 and fold back to provide one of the anchor portions 310a-e at one end and another of the anchor portions 310a-e at the other end of each wire 308. The anchor portions 310a-e may be as described with reference to Figure 3A-3BIn addition, the tissue anchor may also include a tissue piercing element as described above.

[0097] Fig. 6A 300 in a deployed configuration according to an embodiment. The tissue anchor 300 can include a cylindrical portion 302 having a longitudinal axis 660, a proximal end 304, and a distal end 306. The tissue anchor 300 also includes a plurality of anchors 310a-c configured to secure the cylindrical portion 302 beneath a tissue surface 350.

[0098] Each of the plurality of anchors 310a-c includes a substantially linear segment 662 extending parallel to the longitudinal axis 660 from the distal end 306 of the cylindrical portion 302. In addition, the plurality of anchors 310a-c include a curved segment 664 extending from the substantially linear segment 662. The curved segment 664 of each of the plurality of anchors 310a-c may be configured as follows: Figure 6B As shown in the delivery configuration, the substantially linear section 662 is aligned relative to the longitudinal axis 660, and as shown in the Fig. 6A The cylindrical portion 302 is shown curved radially outward relative to the longitudinal axis 660 and toward the distal end 306 of the cylindrical portion 302 in the expanded configuration. Fig. 6A As shown, the cylindrical portion 302 can be disposed within a delivery sheath 452 during delivery.

[0099] In some cases, the cylindrical portion 302 includes one or more notches 668 in the outer surface of the cylindrical portion. The notches 668 are cutouts or removed portions of the material of the cylindrical portion 302. The notches 668 can contribute to the flexibility of the cylindrical portion 302. In some cases, the plurality of anchors 310a-c and the cylindrical portion 302 form a single structure, such as a cutting tube. In addition, the cylindrical portion 302 can include an eyelet 312 that can be configured to interface with the flexible cord 202, as described in detail above, for chordal therapy.

[0100] In some cases, the cylindrical portion 302 also includes a flexible rope pivot 670. Figure 6C As shown, the flexible cord 202 can be disposed within the cylindrical portion 302 and extend around the flexible cord pivot 670. The flexible cord pivot 670 can help secure the flexible cord 202 to the cylindrical portion 302.

[0101] In some cases, the tissue anchor 300 may also include an adjustable mechanism 672. Fig.6DAs shown, the adjustable mechanism 672 can be disposed within the cylindrical portion 302. As shown, the adjustable mechanism 672 can include an insert 674 through which the flexible cord 202 can be disposed. The insert 674 can be secured within the cylindrical portion 302 by an adhesive or an interference fit. The adjustment mechanism 672 can be configured to adjust the length of the flexible cord 202. Tension can be applied to the flexible cord 202 to adjust the length of the flexible cord 202. The adjustment mechanism 672 can include a blade 678 to trim the length of the flexible cord 202. The flexible cord 202 can be disposed and secured within the insert 674.

[0102] Fig. 7A is a perspective view of an illustration of another exemplary tissue anchor 300 according to an embodiment. The tissue anchor 300 can be formed from a wire or a cut tube. The tissue anchor 300 can include a first anchoring segment 750a, the first anchoring segment including a first curved segment 752a and a first tissue piercing element 316a extending longitudinally from the inner surface of the vertex of the first curved segment 752a. The tissue anchor 300 can also include a second anchoring segment 750b, the second anchoring segment including a second curved segment 752b and a second tissue piercing element 316b extending longitudinally from the inner surface of the vertex of the second curved segment 752b. The vertex can be the curved inner surface of the curved segments 752a, 752b.

[0103] The tissue anchor 300 may further include a first transition section 754a disposed between the first anchor section 750a and the second anchor section 750b in a first plane and extending perpendicularly to the first anchor section 750a and the second anchor section 750b. In addition, the tissue anchor 300 may further include a second transition section 754b disposed between the first anchor section 750a and the second anchor section 750b in a second plane and extending perpendicularly to the first anchor section 750a and the second anchor section 750b. In some cases, the first plane and the second plane are spaced apart from each other.

[0104] In some cases, the first transition section 754a and the second transition section 754b are parallel to each other. In addition, the first anchoring section 750a and the second anchoring section 750b can be arranged to be parallel to each other. Further, at least one of the first transition section 754a and the second transition section 754b includes a curvature, such as Fig. 7A shown.

[0105] Figure 7B According to one embodiment, a needle 780 is provided. Fig. 7A. A needle 780 can be used to implant the tissue anchor 300. The needle 780 can be disposed through the first anchoring segment 750a, the second anchoring segment 750b, the first transition segment 754a, and the second transition segment 754b and disposed therebetween. In addition, one or more of the first anchoring segment 750a, the second anchoring segment 750b, the first transition segment 754a, and the second transition segment 754b can be configured to interface with the flexible cord 202 for chordal therapy, as described in detail above.

[0106] Figure 7C According to an embodiment Figure 7A-7B 00 . In some cases, the first anchor segment 750a, the second anchor segment 750b, the first transition segment 754a, and the second transition segment 754b can be configured to deploy into a substantially common plane as shown. Figure 7C The arrangement shown in can also be a cutting pattern (pattern) for the tissue anchor 300 shown.

[0107] Fig. 8A 8 is an illustration of a tissue anchor 300 in a first configuration, in a delivery configuration, according to an embodiment. The illustrated tissue anchor 300 includes a cylindrical portion 302 having an inner lumen 840, a proximal end 302, and a distal end 306.

[0108] The tissue anchor 300 includes a plurality of anchor portions 310a, 310b extending from the inner cavity 840 and radially outward relative to the outer surface of the cylindrical portion 302 (although the tissue anchor 300 may include more anchor portions, such as Figure 8C 306 of the cylindrical portion 302. The flexible cord 202 can extend within the lumen 840 of the cylindrical portion 302 and can be coupled to the ball 842. In some cases, the flexible cord 202 is configured to withdraw the ball 842 toward the proximal end 304 and at least partially within the lumen 840 to change the configuration of the plurality of anchoring portions 310a, 310, such as Figure 8B shown.

[0109] In response to the tension, the plurality of anchors 310a, 310b may open (tilt and spread) more. The plurality of anchors 310a, 310b may be configured to be fixed within the tissue. In addition, the flexible cord 202 may be used for chordal therapy. The ball 842 contacting the anchors 310a, 310b may cause movement of the anchors 310a, 310b.

[0110] Figure 8C According to an embodiment Figure 8A-BFIG. 3 is an illustration of a cutting pattern (pattern) of a portion of a tissue anchor 300 shown in FIG. As shown in the cutting pattern, the tissue anchor 300 may include more than Figure 8A-B , and a greater number of anchoring portions 310a-f are shown in the figure. The tissue anchor 300 can be deployed upward or downward relative to the tissue wall (as other tissue anchors 300 discussed herein can be). In addition, the anchoring portions 310a-f may include a larger or smaller width. In addition, the anchoring portions 310a-f may include sub-anchoring portions 890 (one is highlighted for ease of illustration). The sub-anchoring portions 890 can be deployed as barbs in a direction opposite to the direction of the anchoring portions 310a-f. This may facilitate deployment when the anchoring portions 310a-f are disposed upwardly (wherein the tissue anchor 300 is embedded) to the tissue surface (or therein).

[0111] Fig. 9A 300 is a perspective view of an illustration of another exemplary tissue anchor 300 according to an embodiment. The tissue anchor 300 can include a cylindrical portion 302 having a proximal end 302 and a distal end 306. The tissue anchor 300 can also include an anchoring element 310 configured to secure the cylindrical portion 302 to or below a tissue surface 450.

[0112] As shown, the anchoring element 310 includes a helical structure having a proximal end 924, which is disposed at the distal end 306 of the cylindrical portion 302 and includes a plurality of loops, the diameter of which increases from the proximal end of the helical structure to the distal end 926 of the helical structure. The helical structure with an increased diameter can increase the surface area engagement of the anchoring element 310. In addition, the anchoring element 310 (or any anchoring element discussed herein) can include one or more barbs 928 disposed on the outer surface of the helical structure. The barbs 928 can also clamp the tissue surface 450 to fix the anchoring element 310 therein. As described in detail above, the cylindrical portion 302 can be configured to interface with the flexible rope 202 for chordal therapy.

[0113] Fig.10 is a perspective view of an illustration of another exemplary tissue anchor 300 according to an embodiment. The tissue anchor 300 may include a cylindrical portion 302 having a proximal end 302 and a distal end 306. In addition, a plurality of substantially linear segments 590 (one highlighted for ease of illustration) extend from the distal end 306 of the cylindrical portion 302.

[0114] also, Fig.10The tissue anchor 300 shown in the drawings may include a plurality of helical anchors 592 disposed at the distal end of each of the plurality of substantially linear segments 590. The helical anchors 592 may be configured to secure the cylindrical portion 302 to a tissue wall. Any tissue anchor 300 discussed herein may include an additional helical anchor 592 disposed at the distal end of the anchor (e.g., in place of the penetrating tip 318).

[0115] In some cases, as described in detail above, the cylindrical portion 302 can be configured to interface with the flexible cord 202 configured for chordal therapy.

[0116] Fig.11 is a diagram of an exemplary cutting pattern for a tissue anchor 300 according to an embodiment. As shown, the tissue anchor 300 can include a plurality of anchors 310a-f. The anchors 310a-f can include blunt or non-pointed ends.

[0117] Fig. 12A is a side view of an exemplary tubular member 303 for use as a tissue anchor according to one embodiment. Figure 3A-3C As described in detail, tubular member 303 includes a proximal end 304 and a distal end 306. Tissue anchor 300 also includes at least one wire (or strut formed from a cut tube or cut sheet) disposed through tubular member 303.

[0118] like Fig. 12B and 12C As shown, the tubular member 303 includes a plurality of lumens 970a-d extending between the proximal end 304 and the distal end 306. In addition, the lumens 970a-d are configured to maintain the arrangement of at least one wire 308a, 308b. Likewise, as shown by observing the distal end 306 of the tubular member 303, the tubular member 303 may include an additional opening 972 for the tissue piercing element 316. In some cases, as shown, the additional opening 972 may be only disposed in the distal end 306 of the tubular member 303 and does not extend to the proximal end 304.

[0119] Fig.12D According to an embodiment Figure 12A-12C 303. In some cases, the tubular member 303 can include two sections of different diameters. The first section 303a of the tubular member 303 can be larger than the second section 303b of the tubular member 303. The second section 303b can be the proximal end 304 of the tubular member 303 or the distal end 306 of the tubular member 303. In some cases, the second section 303b is configured to engage a delivery system.

[0120] Fig.13A3 is a proximal end view of an exemplary tubular member 303 and at least one wire 308a, 308b disposed through the tubular member according to an embodiment. Figure 3A-3C As described in detail, the tubular member 303 includes a proximal end 304 and a distal end 306. The tissue anchor 300 also includes at least one wire 308a, 308b disposed through the tubular member 303. In some cases, the at least one wire 308a, 308b includes two wires 308a, 308b. In other cases, the at least one wire 308a, 308b includes a single wire looped through the tubular member 303 or any number of wires disposed through the tubular member 303, as discussed in detail above.

[0121] like Fig.13A As shown, the wires 308a, 308b cross each other at the proximal end 304 of the tubular member 303. The wires 308a, 308b are arranged to pass through the tubular member 303 to form a plurality of anchors 310a-d. Fig. 13B As shown, the wires 308a, 308b do not overlap at the proximal end 304 of the tubular member 303. The wires 308a, 308b are disposed through the tubular member 303 to form a plurality of anchors 310a-d.

[0122] Fig.14A 308a, 308b. 308a, 308b is a side view of an exemplary tissue anchor 300 and a depth indicator 322 according to an embodiment. The tissue anchor 300 also includes a tubular member 303 and at least one wire 308a, 308b disposed through the tubular member 303. In some cases, the at least one wire 308a, 308b includes two wires 308a, 308b. In other cases, the at least one wire 308a, 308b includes a single wire that is looped through the tubular member 303. In still other cases, the at least one wire 308a, 308b includes three, four, five, six, or more wires.

[0123] At least one wire 308a, 308b is arranged to form a plurality of anchors 310a-d extending from the distal end 306 of the tubular member 303.

[0124] The tissue anchor 300 also includes a tissue piercing element 316 extending from the tubular member 303. The tissue piercing element 316 can be disposed between the plurality of anchoring portions 310a-b. In some cases, the tissue piercing element 316 includes a penetration tip 318. The penetration tip 318 can also be configured to anchor within the tissue. In addition, the penetration tip 318 can be helical (e.g., as described in more detail below).

[0125] In some cases, the depth indicator 322 is configured to indicate to the clinician that the plurality of anchors 310a-d are embedded in the tissue. The tissue piercing element 316 can be forced into the tissue, and the depth indicator 322 can provide tactile feedback to the clinician. In some cases, the tissue piercing element 316 is formed from a portion of a wire or a cut tube or a cut sheet. In addition, the tissue piercing element 316 can be formed as Fig.14A As shown, the tissue piercing element 316 may be substantially linear, or in other cases, the tissue piercing element 316 may be as shown. Fig. 14B The spiral shape shown.

[0126] Fig.15A is a distal end view of an exemplary tubular member 303 and position feedback mechanisms 974a-d according to one embodiment. In some cases, the tubular member 303 may include a position feedback mechanism 974a-d disposed at the distal end 306 of the tubular member 303. The position feedback mechanism 974a may be one or more wires or strut elements extending radially outward from the distal end 306. In some cases, the position feedback mechanism 974a-d may take the form of an anchoring portion 310a-d, as discussed in detail above, or the position feedback mechanism 974a-d may be a structure other than an anchoring portion.

[0127] Fig. 15B According to one embodiment, the tissue wall is joined Fig.15A . The position feedback mechanism includes feedback elements 974a-d (e.g., wires, struts, cutting tube elements, cutting sheet elements) or visual feedback configured to indicate the angle of the tissue wall. As shown, the angle of the position feedback elements 974a-d relative to the tubular member 303 indicates the angle or slope of the tissue wall.

[0128] The invention of the present application has been described generally and with reference to specific embodiments above. It will be apparent to those skilled in the art that various modifications and variations may be made to the embodiments without departing from the scope of the present disclosure. Therefore, the embodiments are intended to cover modifications and variations of the present invention as long as they fall within the scope of the appended claims and their equivalents.

Claims

1. A tissue anchor, comprising: a cylindrical portion having a proximal end and a distal end; as well as An anchoring element configured to secure the cylindrical portion to or beneath a tissue surface, wherein the anchoring element comprises a helical structure having a proximal end disposed at the distal end of the cylindrical portion and comprising a plurality of loops.

2. The tissue anchor according to claim 1, characterized in that: The helical structure increases in diameter.

3. The tissue anchor according to claim 2, characterized in that: The increase in diameter of the helical structure is configured to increase surface area engagement of the anchoring element.

4. The tissue anchor according to claim 1, characterized in that: The anchoring element includes one or more barbs.

5. The tissue anchor according to claim 4, characterized in that: The one or more barbs are disposed on an outer surface of the helical structure.

6. The tissue anchor according to claim 4, characterized in that: The one or more barbs are configured to further grip the tissue surface to secure the anchoring element in the tissue surface.

7. The tissue anchor according to claim 1, characterized in that: The cylindrical portion is configured to interface with a flexible cord.

8. The tissue anchor according to claim 1, characterized in that: Also included is a flexible cord coupled to the anchoring element, and a pledget coupled to the flexible cord.

9. The tissue anchor according to claim 1, characterized in that: The anchor includes a pre-deployed configuration including an elongated configuration, and the anchor includes a deployed configuration including a coiled configuration.

10. A tissue anchor, comprising: At least one wire, the at least one wire being configured to form: a first circular portion configured to interface with a flexible cord, one or more tissue-piercing elements configured to engage a tissue surface and to move between a first configuration in which the one or more tissue-piercing elements are disposed substantially parallel to the tissue surface and a second configuration in which the one or more tissue-piercing elements are disposed non-parallel to the tissue surface, and An intermediate portion configured to move the one or more tissue-piercing elements from the first configuration to the second configuration in response to a reduction in diameter of the mid-portion.

11. The tissue anchor according to claim 10, characterized in that The middle portion is substantially elliptical in shape.

12. The tissue anchor according to any one of claims 10 to 11, characterized in that: The at least one wire includes a second circular portion, and the one or more tissue-piercing elements extend from the second circular portion.

13. The tissue anchor according to any one of claims 10 to 11, characterized in that: Also included is a delivery sheath configured to reduce a diameter of the intermediate portion and unconstrain the intermediate portion, thereby allowing the one or more tissue-piercing elements to move from the first configuration to the second configuration.

14. The tissue anchor according to claim 13, characterized in that: The one or more tissue-piercing elements are configured to clamp the tissue surface in response to movement from the first configuration to the second configuration.

15. The tissue anchor according to any one of claims 10 to 11, characterized in that: The flexible tether is configured for coupling the tissue anchor to tissue.

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