Tissue-securing apparatuses and their use

Abstract

A tissue-securing apparatus comprises an anchor, one or more threads coupled to the anchor such that a plurality of thread ends extend proximally therefrom, and a button assembly comprising a plurality of button-assembly members arranged to completely surround, in combination, each of one or more respective hollow passages through the button assembly. When in an assembled state, in which one or more thread ends pass through corresponding hollow passages, and at least two thread ends are tied together to form a loop securing the button assembly to the anchor, the button assembly is disengageable from the thread without cutting the thread by separating a first button- from at least one other button-assembly member.

Description

[0001] TISSUE-SECURING APPARATUSES AND THEIR USE

[0002] FIELD OF THE INVENTION

[0003] The present invention relates to tissue-securing apparatuses and their use, and in particular to buttons and button assemblies for use with deployable and / or retrievable tissue anchors.

[0004] BACKGROUND

[0005] There are a variety of medical devices and procedures used for supporting internal portions of a patient's body such as for treating pelvic organ prolapse. One procedure for treating this type of disorder comprises securing the apex of the vagina to a sacrospinous ligament or other structurally supportive tissue within the pelvic region. In a majority of circumstances, anterior and posterior prolapses are caused by apical support defects. By supporting the vaginal apex region, most of the apically related prolapses of the vaginal area are relieved.

[0006] Conventional prolapse repair procedures require an incision through an abdominal or vaginal approach. In cases of native tissue repair or, in particular, in procedures that include placing a mesh, graft, or other implant within the pelvic region of a patient, the mesh, graft, or other implant is delivered to the pelvic region through one or more incisions. Thus, this requires substantial surgery where a patient can be typically hospitalized for days after the surgery as part of their recovery.

[0007] Systems have been proposed for incisionless transvaginal sacrospinous ligament fixation. For example, coassigned US Patent No. 10,299,828, the teachings of which are incorporated herein in their entirety, discloses a system including an anchoring unit configured to affix a vaginal wall to a sacrospinous ligament, and a piercing tip configured to pierce the vaginal wall and the sacrospinous ligament so as to deploy an anchor. Co-assigned US Patent No. 11,678,965, the teachings of which are incorporated herein in their entirety, discloses an apparatus for affixing a first tissue to a second tissue and methods of manufacturing and using the apparatus, which comprises an elongated needle, a handle, a superelastic anchor comprising at least one normally -expanded elongated hook biased to a contracted state to fit within the elongated needle, a securing element and an advancement mechanism triggerable by the handle.

[0008] Such systems lack effective securing elements, e.g., buttons and button assemblies, that not only can be used for securing threads and / or tissues as needed for transvaginal sacrospinous ligament fixation and similar procedures elsewhere, but also for returning to surgical sites in order to retrieve anchors previously deployed in such procedures.

[0009] SUMMARY

[0010] According to embodiments disclosed herein, a tissue-securing apparatus comprises: (a) an anchor; (b) one or more threads coupled to the anchor such that a plurality of thread ends extend proximally therefrom; and (c) a button assembly comprising a plurality of button-assembly members arranged to completely surround, in combination, each of one or more respective hollow passages through the button assembly. When the tissuesecuring apparatus is in an assembled state in which (i) at least one of the plurality of thread ends passes through a corresponding one of the one or more respective hollow passages, and (ii) at least two of the plurality of thread ends are tied together to form a loop securing the button assembly to the anchor, the button assembly is disengageable from the thread without cutting the thread by separating at least a first button-assembly member of the button assembly from at least one other button-assembly member and / or by moving the at least a first button-assembly member relative to the at least one other button-assembly member.According to embodiments disclosed herein, a button assembly for use in securing placement of a tissue anchor, e.g., with a thread, comprises a plurality of button-assembly members. When the button assembly is in a closed configuration defined by the plurality of button-assembly members completely surrounding in combination each of one or more holes comprising respective hollow passages through the button assembly, at least a first button-assembly member is non-destructively movable relative to, and / or non-destructively separable from, at least one other button-assembly member so as to cause the one or more holes to be not completely surrounded by the plurality of button-assembly members.

[0011] According to embodiments disclosed herein, a button assembly for use in securing placement of a tissue anchor comprises: (a) a button characterized by two opposing major surfaces, each major surface having two rounded and / or broad portions displaced from each other in a longitudinal direction and joined by an intervening narrow portion; and (b) a ring member having a circular footprint or an elongated circular footprint. When the button assembly is in an assembled state in which the ring member surrounds a peripheral edge of the button: one or more gaps between the narrow portion and the ring member define respective hollow passages through the button assembly. In some embodiments, the ring member is non-destructively separable from the button.

[0012] According to embodiments disclosed herein, a button for use in securing placement of a tissue anchor comprises two opposing major surfaces. Each major surface has two rounded broad portions displaced from each other in a longitudinal direction and joined by an intervening narrow portion. The narrow portion has a minimum width in a transverse direction equal to between 33% and 67% of a respective maximum width in the transverse direction of each of the rounded broad portions. Travel between any two points along a peripheral edge between an endpoint of a line segment defining the minimum width and a nearest endpoint of a line segment defining the maximum width includes longitudinal movement in a single longitudinal direction.

[0013] BRIEF DESCRIPTION OF THE DRAWINGS

[0014] The invention will now be described further, by way of example, with reference to the accompanying drawings, in which the dimensions of components and features shown in the figures are chosen for convenience and clarity of presentation and not necessarily for showing the scale. In the drawings:

[0015] Fig. 1 is a schematic illustration of a tissue anchor having a plurality of threads coupled thereto and extending proximally therefrom, according to embodiments of the present invention.

[0016] Fig. 2 is a schematic perspective drawing of an exemplary superelastic anchor comprising a plurality of elongated hooks in an expanded state, according to embodiments of the present invention.

[0017] Fig. 3 A is a schematic drawing of an exemplary button assembly according to embodiments of the present invention.

[0018] Figs. 3B and 3C are respective schematic front-perspective and side views of a first button-assembly member of the button assembly of Fig. 3 A, according to embodiments of the present invention.

[0019] Fig. 3D is a schematic drawing of a second button-assembly member of the button assembly of Fig. 3 A, according to embodiments of the present invention.

[0020] Fig. 4A is a schematic drawing of an exemplary button assembly according to embodiments of the present invention.

[0021] Figs. 4B and 4C are respective schematic front-perspective and side views of a first button-assembly member of the button assembly of Fig. 4A, according to embodiments of the present invention.

[0022] Fig. 4D is a schematic drawing of a second button-assembly member of the button assembly of Fig. 3 A, according to embodiments of the present invention.Fig. 5 is a schematic drawing of an exemplary button assembly according to embodiments of the present invention.

[0023] Figs. 6A, 6B, 6C, 7A, 7B, 7C and 8 are schematic drawings of exemplary button-assembly members of respective button assemblies, according to embodiments of the present invention.

[0024] Fig. 9A is a schematic drawing of an exemplary button assembly according to embodiments of the present invention.

[0025] Fig. 9B shows two button-assembly members of the button assembly of Fig. 10A, in a separated state, according to embodiments of the present invention.

[0026] Figs 10A and 10B are schematic drawings showing first and second faces of an exemplary button assembly, according to embodiments of the present invention.

[0027] Fig. IOC shows two button-assembly members of the button assembly of Figs. 9A and 9B, in a separated state, according to embodiments of the present invention.

[0028] Figs. 11 and 12 are schematic drawings of exemplary respective button assemblies according to embodiments of the present invention.

[0029] Fig. 13 schematically illustrates the exemplary button assembly of Fig. 12 in an unassembled state, according to embodiments of the present invention.

[0030] Fig. 14 is a schematic illustration of an exemplary applicator for deploying therefrom a tissue anchor, according to embodiments of the present invention.

[0031] Fig. 15 is a schematic illustration of the distal end of an elongated needle for piercing one or more tissues and deploying therethrough a tissue anchor, according to embodiments of the present invention.

[0032] Fig. 16 is a schematic cutaway drawing of the elongated needle of Fig. 15, showing a stage of deployment of a tissue anchor, according to embodiments of the present invention.

[0033] Fig. 17 is a schematic illustration showing an exemplary tissue-securing apparatus, according to embodiments of the present invention.

[0034] Figs. 18 and 19 show flowcharts of methods and method steps for securing a tissue, according to embodiments of the present invention.

[0035] Figs. 20 A, 20B, 20C, 20D, 20E and 20F schematically illustrate steps of a method for securing a tissue, according to embodiments of the present invention.

[0036] Figs. 21 A and 2 IB, 22A and 22B, and 23 A and 23B schematically illustrate details of passing thread ends through corresponding hollow passages formed in respective button assemblies and tying the thread ends together to form a respective loop, according to embodiments of the present invention.

[0037] Fig. 24A shows the button assembly of Fig. 12, in an open state and with thread ends passed through a corresponding hollow passage and tied together to form a loop, according to embodiments of the present invention.

[0038] Figs. 24B, 24C and 24D schematically illustrate an exemplary button assembly, respectively in a closed and unconstrained state, in a closed state while constrained by a thread loop, and in an open state while constrained by the thread loop, according to embodiments of the present invention.

[0039] Fig. 25 shows a flowchart of a method for retrieving the anchor of a tissue-securing apparatus, according to embodiments of the present invention.

[0040] Figs. 26 A, 26B, 26C, 26D and 26E schematically illustrate details of disengaging a button assembly from the loop of thread, engaging the loop of thread with a retrieval member, and withdrawing the retrieval member to extract the anchor from the tissue, according to embodiments of the present invention.Fig. 27 shows a flowchart of a method for retrieving the anchor of a tissue-securing apparatus, according to embodiments of the present invention.

[0041] Figs. 28A, 28B, 28C, 28D and 28E schematically illustrate details of disengaging a button assembly from the loop of thread, according to embodiments of the present invention.

[0042] Figs. 29, 30A, 30B, 31 and 32 schematically illustrate certain aspects of the design of exemplary buttonassembly members, according to embodiments of the present invention.

[0043] Fig. 33 schematically illustrates certain aspects of the design of an exemplary button assembly, according to embodiments of the present invention.

[0044] DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

[0045] The invention is herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of the preferred embodiments of the present invention only, and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention, the description taken with the drawings making apparent to those skilled in the art how the several forms of the invention may be embodied in practice. Throughout the drawings, like-referenced characters are generally used to designate like elements. Subscripted reference characters (e.g., 1 Oi) may be used to designate multiple separate appearances of elements of a single species, whether in a drawing or not; for example: 10i is a single appearance (out of a plurality of appearances) of element 10. The same elements can alternatively be referred to without subscript (e.g., 10 and not 10i) when not referring to a specific one of the multiple separate appearances, i.e., to the species in general.

[0046] Some exemplary embodiments of the invention relate to buttons and button assemblies for use as securing elements for tissue anchors - or, equivalently, anchors - deployed in order to secure tissues, e.g., to secure one tissue to another in a fixed position, to prevent movement of one or both of the tissues relative to each other, or to restore a desired position of one or both of the tissues. An illustrative use case for deploying a tissue anchor for securing tissues is transvaginal sacrospinous ligament fixation, a procedure for affixing a vaginal wall to a sacrospinous ligament.

[0047] The term ‘button assembly’ as used herein means a tissue-securing element comprising multiple parts, members or portions. The parts, members or portions, said terms being used interchangeably, can be reversibly attachable to each other and / or arranged to be moved relative to each other. A single-piece button, such as, for example, a surgical button known from orthopedic procedures, does not fall under this definition of a button assembly because it comprises only a single part. A ‘button member’ is a button that can be part of a button assembly, regardless of its present status.

[0048] The term ‘button’ as used herein, including when used as part of the phrase ‘button assembly’, means an element of any shape suitable for the purposes described herein. The buttons illustrated in the drawings attached hereto do not necessarily Took like’ a flat, circular garment button, although some exemplary button assemblies coincidentally do. Others do not.

[0049] Some embodiments of the invention relate to the structural design and / or use of button assemblies as part of a tissue-securing apparatus also comprising an anchor and a plurality of threads that can be used to connect the button with the anchor.As used herein, the terms ‘distal’ and ‘proximal’ follow the convention of ‘distal’ meaning further into the human body and / or further away from a doctor or surgeon, and the term ‘proximal’ meaning the opposite of ‘distal’. For the sake of clarity, this convention is illustrated by an annotated arrow in relevant drawings.

[0050] In embodiments disclosed herein, the plurality of threads can be coupled to a tissue anchor during manufacturing or in any case before deployment of the anchor in a medical procedure. The plurality of threads coupled to the anchor are arranged to extend proximally from the anchor, such that when the anchor is deployed into tissues, proximal ends of the threads can remain outside the tissues.

[0051] The button assemblies disclosed herein are designed to have one or more hollow passages therethrough, formed by the joining of the constituent button-assembly members, and passing through the button assemblies when in an assembled state. In an example, a hollow passage comprises a given hole passing directly through the button assembly, e.g., from ‘front’ to ‘back’, when assembled, while in an unassembled state the existence of the given hole may not even be apparent because one part of the perimeter of the given hole is in a first button-assembly member, and another part of the perimeter of the given hole is in a second button-assembly member. In some embodiments, a hollow passage does not necessarily take a direct front-to-back route through a button assembly, but instead can follow an angled or slanted path, a curved path, or any other non-linear path through the button assembly. A hole or other hollow passage through the button assembly is characterized by being surrounded by the button-assembly members in combination, so as to prevent, for example, a thread partly disposed therewithin (i.e., passing therethrough) from exiting the hole laterally, i.e., without an end of the thread passing through the hole. In some embodiments, there can be additional holes or other hollow passages, i.e., holes through the button assembly that are not hollow passages formed by the assembling of the button-assembly member. These can include ‘permanent holes’ formed in a button. Holes or other hollow passages that are formed by the assembling together of the buttonassembly members cease to be surrounded by the button-assembly members when the button-assembly members are separated from each other. An indication of the members being separated from each other is that the holes formed by the assembling no longer constrain lateral exit of threads passing through them. In embodiments, button-assembly members making up a button assembly can be separated from each other non-destructively.

[0052] In embodiments, the button assembly is used in a procedure to secure an anchor in place and thereby secure a tissue and / or secure tissues to each other. In an exemplary procedure, thread ends, i.e., end of the plurality of threads extending proximally from the anchor, are passed through the one or more hollow passages described above, and tied together to form a loop. When the tying occurs with the anchor in situ, the tied thread can form a loop constraining the movement of the button assembly. The tying can be such that the button assembly is forced against the first tissue (outside, i.e., proximal to, the tissue and also proximate thereto) and the loop thus constrains not only the movement of the button assembly but also the movement of the anchor, which can be prevented from migrating distally.

[0053] In contrast to hollow passages formed by the assembling, holes or other hollow passages that are not formed by the assembling, but that instead are entirely surrounded by a single button-assembly member, e.g., permanent holes, continue to constrain the lateral exit of any threads passing therethrough after the button assembly is disassembled. In some examples, at the point in a procedure when threads are tied together to form the loop, it can be that one thread is passed through a single hollow passage formed only by assembling the button-assembly members and then tied together with a thread that does not pass through the button-assembly at all. In some examples, it can be that one thread is passed through a single hollow passage formed only by assembling the buttonassembly members and then tied together with a second thread that passes through a hollow passage that is not formed by the assembling but rather is formed as a hollow passage through a single button-assembly member.In embodiments, button-assembly members that are components of a button assembly can be separated from each other non-destructively. In an exemplary use case, a tissue-securing apparatus comprising an anchor, a plurality of threads extending proximally from the anchor, and a button assembly, are disposed in situ and in an assembled state, meaning that a distal end of the anchor is in a second tissue, having passed distally through a first tissue, and a plurality of thread ends are tied together to form a loop retaining the button assembly proximal to and proximate to the first tissue. According to the use case, it can be desirable to remove the button assembly without cutting any of the threads. For example, removing the button assembly enables use of the intact loop of thread as an ad hoc handle to retrieve, i.e., pull or withdraw, the anchor from the tissues. Removing the button assembly non-destructively can be a safer alternative to cutting a button to release it from a thread loop, avoiding sharp implements, sharp edges and material shedding. Further, removing the button assembly non-destructively opens up a broader range of construction materials for the button, including stainless steels, titanium, etc., which are not easily cut in situ. Cutting the thread to release the button assembly would then preclude the use of the thread loop as ad hoc handle for retrieving the anchor.

[0054] We now refer to the figures, and in particular to Fig. 1. A tissue anchor 108 comprises a plurality of hooks 117 extending distally and outwardly from a proximal portion 118 of the anchor 108. The hooks 117 are shown in Fig. 1 in an expanded state, i.e., not contracted or constrained. In some embodiments, the hooks can be contracted and / or constrained when the anchor is loaded in a needle for deployment. Other forms of tissue anchors are known in the art, and according to the instant embodiments the anchor of the disclosed tissue-securing apparatus can have a variety of different forms and constructions.

[0055] In embodiments, at least one thread is coupled to the anchor 108, and a plurality of thread ends 127 extends proximally from the anchor 108. While Fig. 1 shows the thread(s) 120 coupled to the proximal end of the proximal portion 118, this is merely for purposes of illustration and the thread(s) 120 can be coupled to any part of the anchor 108. In some embodiments, a single thread 120 is coupled to the anchor, such that two ends 127 of the same single thread 120 extend proximally from the anchor 108, and thus the ‘plurality of threads’ extending proximally from the anchor can be just one thread counted twice. In some embodiments, a plurality of different threads 120 are coupled to the anchor 108, and the plurality of ends 127 are corresponding ends of the respective threads 120 of the plurality of threads.

[0056] Fig. 2 shows a non-limiting example of a tissue anchor 108 of the type illustrated in Fig. 1. In the example of Fig. 2, the anchor 108 comprises four hooks 117 more or less evenly distributed so that there is roughly 90° between each two adjacent hooks 117. In other examples, there can be more or less than 4 hooks, and / or they can be distributed unevenly.

[0057] In embodiments, a first general type of button assembly includes two button-assembly members where a first member colloquially ‘resembles’ a button in that it has two opposing major surfaces and is roughly disk-shaped, yet may be ‘unlike’ a button if it has no thread-holes. In this first general type of button assembly, the second button-assembly member can have the form of a ring that surrounds the first member when the button-assembly members are assembled to form the button assembly. It should be noted that classifying button assemblies into types or categories as described herein is solely for purpose of illustration for understanding the disclosure, and is not a substantive classification.

[0058] Figs. 3 A, 3B, 3C and 3D illustrate a non-limiting example of a button assembly 50 of the first general type of button assembly described above. The exemplary button assembly 50 is shown in an assembled state in Fig. 3 A, in which two button-assembly members 55 are assembled together to form the button assembly 50 having, in the example of Fig. 3 A, two hollow passages 51 therethrough.A first button-assembly member 55i, shown in isolation in Fig. 3B and 3C, is a disk-like ‘buttonresembling’ member having a generally round shape with concave sections in the perimeter disrupting an otherwise convex footprint. For convenience, a button-resembling first button-assembly member is also called, equivalently, a ‘button member’ in this disclosure. The second button-assembly member 552, shown in isolation in Fig. 3D, is ringshaped and sits in a groove 62 in the button member 55i. The groove 62 is shown in Figs. 3B and 3C. For convenience, a second button-assembly member 552 is also called, equivalently, a ‘ring member’ in this disclosure. The ring member 552 of Fig. 3D is circular. In other examples, a ring member can have an elongated circular footprint. In yet other examples, a ring member can have a shape designed to fit around a button member that has an external footprint that is not a circle or an elongated circle. The groove 62 circumscribes at least a portion of the perimeter of the first button-assembly member 55i. The side view of Fig. 3C illustrates a non-limiting example in which the groove 62 circumscribes some but not all of the perimeter of the first button-assembly member 55i. In some designs, the groove 62 may be shallow, and contact only a small part of a transverse circumference of the ring member 552.

[0059] The side view in Fig. 3C seemingly illustrates the two major surfaces 61i, 6I2 as flat surfaces, but in other examples the major surfaces can be rounded or any other non-planar shape suitable for its intended use. The first button-assembly member 55i can be made from any biologically compatible material (or even biodegradable material) with a wide range of stiffness. On the other hand, it can be desirable for the second button-assembly member 552 to be manufactured from a material that is sufficiently elastic, i.e., has a sufficiently low modulus of elasticity, to allow the first button-assembly member 55i to enter and depart the groove 62 at least once without breaking, tearing or permanently deforming. In some embodiments, a suitable range of elasticity can be determined empirically based, inter alia, on the depth of the groove.

[0060] The two hollow passages 51i, 512 are formed in the button assembly 50 by the presence of the two concave sections in the first button-assembly member 55i causing there to be corresponding gaps between the perimeter of the first button-assembly member 55i and the second button-assembly member 552. The hollow passages 51 through the button assembly 50 are formed when the button-assembly members 55 are assembled together to form the button assembly 50. According to embodiments, each of the hollow passages 51 can be used to pass respective threads therethrough when the button assembly 50 is deployed in a procedure as described hereinbelow.

[0061] Figs. 4A, 4B, 4C and 4D illustrate another button assembly 50 of the first general type of button assembly described above. This second exemplary button assembly 50 is shown in an assembled state in Fig. 4A, where two button-assembly members 55 are assembled together to form the button assembly 50 which also has, in the nonlimiting example of Fig. 4A, two hollow passages 51 therethrough. The second button-assembly member 552 of Fig.

[0062] 4 A, also shown in isolation in Fig. 4D, is shown as a different type of peripheral ring from that of Figs. 3 A and 3D and has a generally flat profile. In contrast to the previous example illustrated in Figs 3A-3D, the ring of Figs. 4A and 4D surrounds most or all of the thickness of the first button-assembly member 55i and does not necessarily sit in a groove. In embodiments, the inner diameter of the second button-assembly member 552 of Fig. 4A is selected so as to fit tightly over the first button-assembly member 55i, and, in some implementations, to apply a peripheral clamping force so as to remain in place during handling and deployment. Thus, the button member 55i of Figs. 4A-4C is shown to have a shape similar to that of the first button-assembly member 55i of Figs. 3A-3C, but optionally without the perimeter groove 62, as evidenced by the non-grooved surface 66 shown in Fig. 4B. In embodiments, the button member 55i of Fig. 3B can be used interchangeably with the button member 55i of Fig. 4B together with the ring member 552 of Fig. 4D.Another button assembly 50 of the first general type of button assembly described above is shown in Fig. 5. In the non-limiting example of Fig. 5, a ring-like second button-assembly member 552 includes one or more features, e.g., a snap closure mechanism 68, for clamping and / or releasing the corresponding first button-assembly member 55i.

[0063] In some embodiments, a ring member 552 used as a second button-assembly member can be reversibly and non-destructively separable into a plurality of ring-member parts.

[0064] In embodiments, a design feature common to the exemplary button assemblies 50 of Figs. 3 A, 4A and 5 is the formation of gaps (hollow passages 55) formed between the button 55i and the ring 552. In the exemplary button assemblies 50 of Figs. 3 A, 4A and 5 in the assembled state as shown, at least 30% of an arc length (i.e., the circumference) of the ring member 552 is in physical contact with the button member 55i. In some designs, at least 50% of the circumference is in physical contact with the button member 55i. In the exemplary button assemblies 50 of Figs. 3 A, 4 A and 5 in the assembled state as shown, no more than 90% of the circumference of the ring member 552 is in physical contact with the button 55i. In some embodiments, no more than 80% of the circumference of the ring member 552 is in physical contact with the button 55i. In some embodiments, no more than 70% of the circumference of the ring member 552 is in physical contact with the button 55i. In the exemplary button assemblies 50 of Figs. 3 A, 4A and 5 in the assembled state as shown, at least 30% of the peripheral edge of the button 55i is in physical contact with the ring member 552. In some embodiments, at least 50% of the peripheral edge of the button 55i is in physical contact with the ring member 552.

[0065] Figs. 6A, 6B, 6C, 7A, 7B and 7C show additional examples of buttons which can be used as first buttonassembly members 55i with corresponding ring members 552 to form respective button assemblies 50. Assembly of any of these exemplary buttons 55i with a corresponding ring member 552 will form a plurality of hollow passages 51 through the assembled button assemblies 50. In the case of the exemplary buttons 55i of Figs. 6A and 6B, the ring member 552 can have an elongated circular footprint.

[0066] Fig. 8 shows an exemplary button that can be used as a first button-assembly member 55i with a corresponding ring member 552 to form a respective button assembly 50. Assembly of the button member 55i of Fig. 8 with a corresponding ring member 552 will form a single hollow passage 51 when assembled.

[0067] In embodiments, a second general type of button assembly includes (at least) two button-assembly members which combine to form a button-resembling button assembly having at least one thread-hole formed by the assembling of the button assembly.

[0068] An exemplary button assembly 50 of the second general type as described above is illustrated schematically in Figs. 9A and 9B. The exemplary button assembly 50 of Fig. 9A comprises two hollow passages 51 formed by the assembly together of the two button-assembly members 55 shown in Fig. 9B. Neither of the holes (hollow passages 51) exists as a surrounded hollow passage in either of the individual button-assembly members 55, as they are formed only by the assembling, and in the assembled button assembly 50 are surrounded by the buttonassembly members 55 only in combination.

[0069] A second exemplary button assembly 50 of the second general type as described above is shown in Figs.

[0070] 10A, 10B and 10C. Figs. 10A and 10B show two views of the assembled button assembly 50 and Fig. 10C shows two separated button-assembly members 55. Fig. 10B shows two hollow passages 51 which are formed by the assembly of the two assembly members 55, but, in contrast to Figs. 9A-9B, a single button assembly member 55i has a hollow passage 52 therethrough.

[0071] A third exemplary button assembly 50 of the second general type is shown in Fig. 11. The button assembly 50 is formed by the assembly of two button-assembly members 55 (not shown), neither of which surrounds a hollowpassage therethrough, such that the single hollow passage 51 through the button assembly 50 is formed by the assembling.

[0072] All of the button assemblies 50 illustrated in Figs. 3 A, 4A, 5, 9A, 10A-10B and 11 comprise multiple button-assembly members 55 which are non-destructively separable from each other. With the exception of Figs.

[0073] 10A-10B, all of the hollow passages 51 in these button assemblies 50 are formed by the assembling of the button assembly 50 and are surrounded by the respective button-assembly members only in combination. Further, the design of all of the button assemblies 50 illustrated in Figs. 3 A, 4A, 5, 9A, 10A-10B and 11 is such that separating the button-assembly members 55 from each other would be effective to non-destructively remove the button assembly 50 from a loop of thread having threads passing through the respective hollow passages 51 of the button assembly 50.

[0074] Fig. 12 is a schematic illustration of an exemplary button assembly 50 formed from two button assembly members 55i, 552 which are not necessarily non-destructively separable from each other but instead are movable relative to each other to other. The arrow 650 indicates the direction of ‘opening’ the button assembly 50 when in a ‘closed’ state, by moving, e.g., rotating, extending along a peripheral path, or pivoting, the second button-assembly member 552 in the direction indicated, relative to the first button-assembly member 55i. The closed state is one in which at least one hollow passage 51 is surrounded, in combination, by a plurality of button-assembly members 55.

[0075] In some designs, the rotation of the second button-assembly member 552 can be facilitated by grasping, e.g., with a surgical tool, a surface feature such as, for example, the raised feature 67 of Fig. 12. Rotation is not necessarily the only movement that can be used in the design of a button assembly for ‘closing’ the assembly to form a hollow passage, and for ‘opening’ the assembly in order to disengage with a thread loop. In other examples, the moving of one button-assembly member relative to one or more other button-assembly members includes linear motion, and / or extension along a peripheral path.

[0076] Fig. 13 is shows the exemplary button assembly 50 of Fig. 12 in an ‘open’ state, i.e., which is not in an assembled state in which a respective hollow passage 51 is surrounded by a plurality of button-assembly members 55. This is in contrast to the state of the button assembly 50 in Fig. 12 is ‘closed’, as shown in Fig. 12, and the hollow passage 51 is surrounded, in combination, by a plurality of button-assembly members 55. The transition from the closed state to the open state is caused by the rotation of the second button-assembly member 552, e.g., to the position shown in Fig. 13, as described above.

[0077] We now refer to Figs. 14, 15 and 16. Fig. 14 is a schematic illustration of an exemplary applicator 100 for a tissue anchor 108, according to embodiments. The applicator 100 comprises a handle portion 124 and a shaft portion 102 joined to the handle 124 at the proximal end 110 of the shaft portion 102. An elongated needle 104 (not shown in Fig. 14) is disposed within the shaft portion 102 and can be extended, e.g., by a control element (not shown) in the handle portion 124, through the distal opening 112 of the shaft portion 102. A tissue anchor 108 (also not shown in Fig. 14) is disposed within the shaft portion 102 and specifically within the elongated needle 104. Fig.

[0078] 15 schematically illustrates a distal portion of the elongated needle 104, including a distal opening 116 and a distal piercing tip. As shown in the cutaway view of Fig. 16, a tissue anchor 108 is disposed within the elongated needle 104 for deployment in the tissues to be secured once the elongated needle 104 reaches a deployment site. In the example of Fig. 16, the anchor 108 is shown schematically as having a distal portion outside the distal opening 116 of the elongated anchor 104. The design of the applicator 100 of Fig. 14 is a single, non-limiting example, and many other possible designs are known.

[0079] In embodiments, a tissue-securing apparatus 200 as schematically illustrated in Fig. 17 comprises an anchor 108, one or more threads 120 coupled to the anchor such that a plurality of thread ends 127 extend proximallytherefrom, and a button assembly 50 comprising a plurality of button-assembly members 55, e.g., any of the corresponding button-assembly members 55 described above and illustrated in Figs. 3A-13.

[0080] Figs. 18 and 19 show flowcharts of methods for securing a tissue; Figs. 20A-20F schematically illustrate selected steps of these methods. Referring now to Fig. 18, a method is disclosed for securing a tissue. An example of tissues to be secured is illustrated schematically in Fig. 20 A, in which a first tissue 690 is to be secured to a second tissue 692. As illustrated by the flowchart in Fig. 18, the method comprises at least the five method steps SOI .. S05:

[0081] Step SOI includes providing an applicator 100 comprising an elongated needle 104, and providing a tissuesecuring apparatus 200, e.g., the tissue-securing apparatus 200 of Fig. 17 which includes an anchor 108 and one or more threads 120 coupled to the anchor such that a plurality of thread ends 127 extend proximally therefrom, and a button assembly 50 comprising a plurality of button-assembly members 55, e.g., any of the corresponding button assemblies 50 and button-assembly members 55 described herein and illustrated in Figs. 3A-13. In some embodiments, providing the applicator 100 includes positioning of the distal end 112 of the shaft portion 102 of the applicator 102 proximate to the first tissue 690, as illustrated in Fig. 20 A. According to the embodiments, when the distal end 112 of the shaft portion 102 is positioned proximate to the first tissue 690, the anchor 108 and the threads 120 coupled thereto are disposed within the elongated needle 104, which is disposed within the shaft portion 102.

[0082] Step S02 includes sequentially piercing a first tissue 690 by the distal piercing tip 118 and penetrating a second tissue 692 with a distal end 116 of the elongated needle 104, as illustrated in Fig. 20B.

[0083] Step S03 includes ejecting, e.g., propelling, the anchor 104 out of the distal end 116 of the elongated needle 104 to cause a distal portion of the anchor 104 to extend distally outward and into (or, in some embodiments, beyond) the second tissue 692, as illustrated in Fig. 20C, where the arrow marked 705 indicates the direction of ejection.

[0084] Step S04 includes passing the at least one of the plurality of thread ends 127 through the corresponding one or more respective hollow passages 51, as illustrated in Fig. 20D.

[0085] Step S05 includes tying at least two of the plurality of thread ends 127 together to form a loop 128 and secure the button assembly 50 to the anchor 104, as illustrated in Fig. 20F. In some embodiments, after the tying of Step S05, the button assembly 50 is disposed proximal to the first tissue 690 and in proximity thereto Referring now to Fig. 19, a method is disclosed for securing a tissue. An example of tissues to be secured is illustrated schematically in Fig. 20 A, in which a first tissue 690 is to be secured to a second tissue 692. As illustrated by the flowchart in Fig. 18, the method comprises at least the six method steps Sil .. S16:

[0086] Step Sil includes providing an applicator 100 comprising an elongated needle 104, and providing a tissuesecuring apparatus 200, e.g., the tissue-securing apparatus 200 of Fig. 17. The tissue-securing apparatus 200 includes an anchor 108, one or more threads 120 coupled to the anchor such that a plurality of thread ends 127 extend proximally therefrom, and a button assembly 50 comprising a plurality of button-assembly members 55, e.g., any of the corresponding button-assembly members 55 described above and illustrated in Figs. 3 A-13. In some embodiments, providing the applicator 100 includes positioning of the distal end 112 of the shaft portion 102 of the applicator 102 proximate to the first tissue 690, as shown in Fig. 20 A. According to the embodiments, the anchor 108 and the threads 120 coupled thereto are disposed within the elongated needle 104, which is disposed within the shaft portion 102, when the distal end 112 of the shaft portion 102 is positioned proximate to the first tissue 690.

[0087] Step S22 includes sequentially piercing a first tissue 690 by the distal piercing tip 118 and penetrating a second tissue 692 with a distal end 116 of the elongated needle 104, as illustrated in Fig. 20B.Step S13 includes ejecting the anchor 104 out of the distal end 116 of the elongated needle 104 to cause a distal portion of the anchor 1014 to extend distally outward and into or beyond the second tissue 692, as illustrated in Fig. 20C, where the arrow marked 705 indicates the direction of ejection.

[0088] Step S14 includes passing the at least one of the plurality of thread ends 127 through the corresponding one of the one or more respective hollow passages 51, as illustrated in Fig. 20D.

[0089] Step S15 includes positioning the button assembly 50 to be proximal to the first tissue 690 and in proximity thereto, the position illustrated in Fig. 20E.

[0090] Step S16 includes tying at least two of the plurality of thread ends 127 together to form the loop 128 and secure the button assembly 50 to the anchor 104, as illustrated in Fig. 20F. In some embodiments, the forming of the loop 128 is effective to prevent movement of the anchor 104 in at least one direction.

[0091] In any of the methods disclosed herein, it is not necessary for all of the steps to be performed. Any of the method steps may be combined with method steps from other methods disclosed herein in any combination.

[0092] We now refer to Figs. 21A-21B, 22A-22B and 23A-23B, which illustrate the tying of thread ends 127 to form knots 125 and thus close respective thread loops 128.

[0093] Figs. 21 A and 2 IB illustrates method steps applied to the exemplary button assembly 50 illustrated in Fig.

[0094] 3 A. The skilled artisan will appreciate that the features applied in Figs. 21A-21B are equally applicable to the button assemblies 50 of Figs. 4A and 5, as well as to other button assemblies 50 in which a second button-assembly member 552 surrounds the perimeter of a first button-assembly member. As illustrated in Fig. 21 A, the ends of threads 120 are passed through corresponding hollow passages 51 in the button assembly 50 in Step S04 of Fig. 18 or Step S14 of Fig. 19. As illustrated in Fig. 21B, the two thread ends are tied together in Step S05 of Fig. 18 or Step S16 of Fig. 19,.

[0095] Figs. 22A and 22B illustrates method steps applied to the exemplary button assembly 50 illustrated in Fig.

[0096] 8, which has exactly one hollow passage 51 therethrough that is formed by the assembling of the button-assembly members 55. The skilled artisan will appreciate that the features applied in Figs. 22A-22B are equally applicable to the button assemblies 50 of Figs. 11 and 12, as well as to other button assemblies 50 comprising only one hollow passage 51 therethrough that is formed by the assembling of the button-assembly members 55. In this scenario, the end of a first thread 120i is passed through the only hollow passage 51 formed between the button member 55i and the ring member 552 in Step S04 of Fig. 18 or Step S14 of Fig. 19, as illustrated in Fig. 21A, and second thread 1202 (or more than one thread) is selected from the remaining one or more threads 120 extending proximally from the in situ anchor 104. The two thread ends are tied together in Step S05 of Fig. 18 or Step S16 of Fig. 19, as illustrated in Fig. 22B.

[0097] Figs. 23 A and 23B illustrates method steps applied to the exemplary button assembly 50 illustrated in Fig.

[0098] 9 A. The skilled artisan will appreciate that the features applied in Figs. 23 A-23B are equally applicable to the button assembly 50 of Fig. 10A, as well as to other button assemblies 50 comprising two hollow passages 51 therethrough that are formed by the assembling of the button-assembly members 55. As illustrated in Fig. 23 A, the ends of threads 120 are passed through corresponding hollow passages 51 in the button assembly 50 in Step S04 of Fig. 18 or Step S14 of Fig. 19. As illustrated in Fig. 23B, the two thread ends are tied together in Step S05 of Fig. 18 or Step S16 of Fig. 19.

[0099] Fig. 24B is a schematic illustration of an exemplary button assembly 50 similar to the one shown in Fig. 12, with the addition of a hollow passage 52 formed wholly within the first button-assembly member 55i. In a use case based on the exemplary button assembly 50 of Fig. 24B, the button assembly 50 can be deployed, e.g., in a tissuefixation procedure, by passing at least one thread 120 through the hollow passage 51 formed when the secondbutton-assembly member 552 is rotated relative to the first button-assembly member 55i to the ‘closed’ position as described above (in the direction opposite that indicated by arrow 650). and by passing at least one thread 120 through the hollow passage 52 formed wholly within the first button-assembly member 55i. Fig. 24C illustrates method steps applied to the exemplary button assembly 50 illustrated in Fig. 24B. The skilled artisan will appreciate that the features applied in Figs. 23A-23B are equally applicable to the button assembly 50 of Fig. 10A, as well as to other button assemblies 50 comprising a first thread 120i passed through the hollow passage 52 formed wholly within, and surrounded by, the first button-assembly member 55i, and a second thread 1202 passed through the hollow passage 51 formed by the assembling of the button-assembly members 55 in Step S04 of Fig. 18 or Step S14 of Fig. 19. The two thread ends are tied together in Step S05 or Step S16, as illustrated in Fig. 24C.

[0100] In embodiments, the tissue-securing apparatuses 200 and button assemblies 50 disclosed herein are designed to enable retrieval of a deployed tissue anchor 104 from an in situ condition. In an illustrative use case, the anchor 104 is deployed for tissue fixation at a first time, and is retrieved therefrom at a second time. The first and second time may be separated by minutes, hours, days, weeks, months or longer. The in situ condition of an anchor 140 deployed according to the embodiments disclosed herein is such that a distal end of the anchor 104 comprising a plurality of hooks 114, in disposed in (or, in some implementations, beyond) a second tissue 692, i.e., a tissue more distal than the first tissue 690. A plurality of threads 120 (a plurality of thread ends 127 from a single, doubled-over thread 120) extend proximally from the anchor 104, with the ends 127 of the threads 120 being external to, and proximal to, the first tissue 690. The threads 120 form, in combination with the anchor 104 a loop 128 comprising a knot 125 formed by tying together two (or more) threads 120 or thread ends 127. One or more of the threads 120 pass through a corresponding one or more hollow passages 51 formed by assembling a plurality of button-assembly members 55 into a button assembly 50, such that the button assembly 50 is ‘trapped’ by the loop 128. The term ‘trapped’ is used to indicate that the one or more threads 120 are constrained laterally by the corresponding hollow passage(s) such that the button assembly 50 cannot be removed without cutting the thread or disengaging the button assembly 50 from the loop by either destructive or non-destructive means.

[0101] As already discussed hereinabove, non-destructive means can be preferable for disengaging a button assembly 50. In embodiments, the retrieval can be carried out by non-destructively disengaging a button assembly 50 from the thread loop 128 without cutting a thread 120, for example by separating at least a first button-assembly member 55 of the button assembly 50 from at least one other button-assembly member 55. Additionally or alternatively, the disengagement of the button assembly 50 can be effected by moving at least a first buttonassembly member 55 relative to one or more other button-assembly members 55. The latter approach is effective for button assemblies 50 of the type illustrated in Fig. 12.

[0102] Referring now to Fig. 25, a method is disclosed for retrieving the anchor 104 of a tissue-securing apparatus from an in situ position in which at least a distal portion of the anchor 104 is embedded in a tissue 692 and the button assembly 50 is not embedded in a tissue 690. The in situ condition of an anchor 104 is schematically illustrated in Fig. 26A. As illustrated by the flowchart in Fig. 18, the method comprises at least the three method steps S21 .. S23:

[0103] Step S21 includes disengaging the button assembly 50 from the thread 120, i.e., from the loop 128, by separating the at least a first button-assembly member 55i of the button assembly from the at least one other buttonassembly member 552. Fig. 26B shows a schematic representation of carrying out Step S21. As shown in Fig. 26B, in an exemplary procedure, a doctor 90 separates a first button-assembly member 55i and a second button-assembly member 552 from each other, and removes both button-assembly members 55 from the loop 128, as indicated by the arrows marked 780 and 790 in Fig. 26B. The button assembly of Figs. 9A-9B is used here as a non-limiting examplefor purposes of explaining the method. The procedure of Step S21 can be performed with any button assembly 50 of the second general type described above, i.e., a button assembly 50 formed by assembling together a plurality of non-destructively separable button-assembly members 55, such as, without limitation, the button-assembly members 55 of Figs. 10-10C orFig. 11.

[0104] Fig. 26B illustrates separation of two button-assembly members 55 from each other in order to disengage the button assembly 50 from the loop 128. In implementations in which the button-assembly members 55 are movable relative to each other rather than separable from each other, the method step can be carried out by moving one button-assembly member relative to at least another button-assembly member, as illustrated in Figs. 24A and 24D. Fig. 24A shows the button assembly of Figs. 12-13, constrained by the thread loop 128 formed by tying together threads 120i, 12(h. with the button-assembly member 552 rotated relative to button-assembly member 551.to place the button assembly 50 in an open, i.e., disassembled, state.

[0105] Similarly, Fig. 24D shows the button assembly of Figs. 24B-24C, constrained by the thread loop 128 formed by tying together threads 120i, 1202, with the button-assembly member 552 rotated relative to buttonassembly member 551 to place the button assembly 50 in an open, i.e., disassembled, state. In some embodiments, disengaging such a button assembly 50 from the thread may include not only moving second button-assembly member 552 but also taking another action involving the directly engaged (i.e., directly engaged via hollow passage 52) button-assembly member 55i.

[0106] Step S22 includes engaging the loop of thread 128 with a retrieval member 180. A retrieval member 180 according to embodiments can comprise a hook, as shown schematically in Fig. 26C, or a thread or wire (or any similarly elongated element) as shown schematically in Fig. 26D. ‘Engaging’ includes placing the retrieval member 180 in a position to pull the loop 128 so as to extract the anchor 104. In most cases, it is sufficient to place the retrieval member 180 within the loop as shown in Figs. 26C and 26D. In another example (not shown) a retrieval member 180 in the form of a wire or thread is tied to the loop 128. In some embodiments, an article of manufacture comprises the tissue-securing apparatus 200 according to embodiments, not in the assembled state, and a retrieval member 180 comprising at least one of a hook, a thread and a wire.

[0107] Step S23 includes withdrawing the retrieval member 180 to extract at least the distal portion of the anchor 104 from the tissue 690, 692 and retrieve the anchor from the in situ position. As illustrated in Fig. 26E (showing a wire as the retrieval member 180 in a non-limiting example), the retrieval member 180, engaged with the thread loop 128, is withdrawn, e.g., pulled, proximally, as indicated by arrow 850. This withdrawal is effective to extract the anchor 108 from the tissues 690, 692 as indicated by arrow 860. In order to perform Step S23 as planned, and as can be understood from Fig. 26E, it can be desirable for the coupling of the threads 120 to the anchor 104 to be sufficiently robust for the purpose. For example, the threads 120 can be tied to the a proximal portion, e.g., base 118, of the anchor 108. In another example, the threads can be engaged with, or pass through, a hole in the base 118 of the anchor 108. Further, the skilled artisan will appreciate that selection of an anchor 104 intended for future retrieval in this manner, e.g., by performing at least Step S23, should be made with this procedure in mind. For example, some anchors have distal elements set at fixed angles to a main anchor element, and such anchors are likely to cause tissue damage if extracted in this manner. As another example, anchors having barbs or similar features on the distal hooks are likely to cause tissue damage if extracted in this manner. Thus, it can be desirable to select an anchor design that when deployed provides sufficient grasp of tissue so as to adequately resist movement in vectors that are not the extraction direction, e.g., of arrow 860 in Fig. 26E, but which provide reduced resistance in the extraction direction when the extraction force is applied. Non-limiting examples of such suitable anchors include the anchors 104 of Figs. 1 and 2.Referring now to Fig. 27, a method is disclosed for retrieving the anchor 104 of a tissue-securing apparatus from an in situ position in which at least a distal portion of the anchor 104 is embedded in a tissue 692 and the button assembly 50 is not embedded in a tissue 690. According to the method, the button assembly 50 is of the first general type described above where a ring-shaped second button-assembly member 552 surrounds the perimeter of a button-like first button-assembly member 552. The in situ condition of an anchor 104 is schematically illustrated in Fig. 28A. The button assembly 50 of Fig. 3 A is used here as a non-limiting example for purposes of illustrating the method. The steps of the method are applicable to the button assemblies 50 of Figs. 4A and 5, as well as to any other button assemblies in which a ring member surrounds a button member. As illustrated by the flowchart in Fig. 27, the method comprises at least the three method steps S31 .. S33:

[0108] Step S31 includes separating the ring member 552 from the button member 55i. Two approaches to separating the ring member 552 from the button member 55i are shown. A first approach is shown in Fig. 28B. As indicated by the arrow 810 in Fig. 28B, in an exemplary procedure, a doctor 90 removes the ring member 552 from the button member 55i. A second approach is shown in Figs. 28C-28D. In an exemplary procedure, a doctor 90 cuts ring member 552 to facilitate removal from the button member 55i. The non-limiting example of Fig. 2C shows use of a pair of scissors 91 but any cutting implement can be used, such as, for example, a scalpel. As indicated by the arrow 815 in Fig. 28D, the doctor 90 then removes the cut ring member 552 from the button member 55i. In embodiments, Step S31 also includes disengaging the button member 55i from the thread loop 128 after the ring member 552 is removed. Removal of the button member 55i from engagement with the thread loop 128 is indicated by the arrow 820 in Fig. 28E. In some examples not shown), the doctor holds the button member 55i in place while removing the ring member 552, and then removes the button member 55i with the tool used to hold the button member 55i in place.

[0109] Step S32 includes engaging the loop of thread 128 with a retrieval member 180. A retrieval member 180 according to embodiments can comprise a hook, as shown schematically in Fig. 26C, or a thread or wire (or, equivalently, any similarly elongated element) as shown schematically in Fig. 26D. The retrieval member 180 is placed in a position to pull the loop 128 so as to extract the anchor 104. In most cases, it is sufficient to place the retrieval member 180 within the loop as shown in Figs. 26C and 26D. In another example (not shown) a retrieval member 180 in the form of a wire or thread is tied to the loop 128.

[0110] Step S33 includes withdrawing the retrieval member 180 to extract at least the distal portion of the anchor 104 from the tissue 690, 692 and retrieve the anchor from the in situ position. As illustrated in Fig. 26E (showing a wire as the retrieval member 180 in a non-limiting example), the retrieval member 180, engaged with the thread loop 128, is withdrawn, e.g., pulled, proximally, as indicated by arrow 850. This withdrawal is effective to extract the anchor 108 from the tissues 690, 692 as indicated by arrow 860. In order to perform Step S33 as planned, and as can be understood from Fig. 26E, it can be desirable for the coupling of the threads 120 to the anchor 104 to be sufficiently robust for the purpose. For example, the threads 120 can be tied to the a proximal portion, e.g., base 118, of the anchor 108. In another example, the threads can be engaged with, or pass through, a hole in the base 118 of the anchor 108. Further, the skilled artisan will appreciate that selection of an anchor 104 intended for future retrieval in this manner, e.g., by performing at least Step S33, should be made with this procedure in mind. For example, some anchors have distal elements set at fixed angles to a main anchor element, and such anchors are likely to cause tissue damage if extracted in this manner. As another example, anchors having barbs or similar features on the distal hooks are likely to cause tissue damage if extracted in this manner. Thus, it can be desirable to select an anchor design that when deployed provides sufficient grasp of tissue so as to adequately resist movementin vectors that are not the extraction direction, e.g., of arrow 860 in Fig. 26E, but which provide reduced resistance in the extraction direction. Non-limiting examples of such suitable anchors include the anchors 104 of Figs. 1 and 2.

[0111] The method steps illustrated in Figs. 26A-26E and 28A-28E describe a process in which button-assembly members 55 are separated from each other in order to disengage the respective button assemblies 50 from the thread loops 128. A method is disclosed for disengaging button assemblies 50 from the thread loops 128 by moving one button-assembly member 55 relative to one or more other button-assembly members 55, e.g., as illustrated in Figs.

[0112] 24A and 24D. According to embodiments, the method comprises a first method step that includes disengaging the button assembly 50 from the thread 120, i.e., from the loop 128, by moving, e.g., non-destructively, the at least one button-assembly member 55 of the button assembly relative to the at least one other button-assembly member 55. After the moving, the hollow passage formed in the button assembly by the ‘closing’ rotation of the at least one button assembly becomes ‘open’ and thus it is possible to non-destructively disengage the button assembly 50 from the loop 128. An example of a button assembly 50 suitable for disengagement from the thread loop 128 in this manner is the button assembly 50 of Fig. 12. The moving includes rotating the second button-assembly member 552 relative to the first button-assembly member 55i e.g., in the direction indicated by arrow 650 in Fig. 12. The method additionally comprises Steps S22 and S23 of Fig. 25, which are illustrated in Figs. 26C-26F.

[0113] The foregoing methods can also be applied to when the button assembly 50 in situ has a thread 120 passing through a hollow passageway 52 formed in and surrounded by a single button-assembly member 55, such as, in a non-limiting example, the button assembly 50 of Fig. 24D. Any of the foregoing methods can be used in similar fashion to allow the threads 120 of the loop 128 to disengage, e.g., be released, from the hollow passages 51 that had been surrounded by respective pluralities of button-assembly members 55 only in combination. After performing, for example, Step S21 of Fig. 25 or Step S31 of Fig. 27, the thread loop 128 can be engaged and withdrawn by a retrieval member 180. The button-assembly member 55 remaining suspended on a single thread 120 need not hinder performing the engaging of Step S22 and withdrawing of Step S23 of Fig. 25.

[0114] We now refer to Figs. 29, 31 and 32, schematic drawings of button members 55 according to embodiments. Fig. 29 shows an exemplary button member 55 according to the first general type of button assembly 50 described above, comprising a button member 55i surrounded by a ring member 552, and specifically according to the examples of Figs. 3A-3C, 4A-4C and 5. The button 55 of Fig. 29 is characterized by two opposing major surfaces 61, as shown in Fig. 3C. Each major surface 61 comprises two rounded and / or broad portions 63 displaced from each other in a longitudinal direction which is indicated by arrow 875. and joined by an intervening narrow portion 64. In some embodiments, each of the rounded broad portions 63 has a shape emulating a two-dimensional projection of an oblate spheroid or ellipsoid, the emulating being accurate within ±10% at any given circumferential point. In some embodiments, the two-dimensional projection (footprint) of the narrow portion 64 has a concave quadrilateral shape comprising four concave sides, known as a Joachimsthal tetracuspid, the emulating being accurate within ±10% at any peripheral point. Fig. 31 shows another exemplary button member 55 according to the first general type of button assembly 50 described above, comprising a button member 55i surrounded by a ring member 552. The rounded broad portions 63 of the exemplary button member 55 of Fig. 31 are more circular than oblate or ellipsoid and the ring member 552 (not shown) is necessarily elongated in comparison to the ring members 552 of Fig. 3D, 4D or 5.

[0115] Fig. 32 shows the button member 55 of Fig. 1, annotated to show a minimum width WMIN of the narrow portion 64 and a maximum width WMAX of a broad portion 63. In embodiments, the narrow portion 64 has a minimum width WMIN in a transverse direction, i.e., transverse to the longitudinal direction indicated by arrow 875in Fig. 29, equal to between 33% and 67% (inclusive) of a respective maximum width WMAX in the transverse direction of each of the rounded broad portions 63.

[0116] In embodiments, it can be desirable for a button member according to the first general type of button assembly described above, i.e., a button assembly comprising a button member surrounded by a ring member, to have a peripheral edge that does not snag the thread loop, or snag on the thread loop, when separating the ring member from button member in Step S31 of Fig. 27, as illustrated in Fig. 28B. A distinguishing feature of the exemplary button members 55 of Figs. 3A-3C, 4A-4C, 5, and 29-31 is that travel between any two points along a peripheral edge of the button member 55 between an endpoint of a line segment defining the minimum width WMIN and a nearest endpoint of a line segment defining the maximum width WMAX includes longitudinal movement in a single longitudinal direction. The travel can be, for example, of a thread 120, e.g., the thread 120 in Fig. 28B, there the thread 120 may be looped around the button member 55 at the narrow portion 64, and removing the button member 55, as illustrated in Fig. 28C, can be easier and go more smoothly in some applications if the button member 55 has this feature. This feature is also shared by the exemplary button members 55 of Figs. 6A-6C and 8. For purposes of illustration, it can be noted that the button members 55 of Figs. 7A-7C do not share this feature.

[0117] We now refer to Fig. 33, which shows an annotated button assembly 50 according to the first general type of button assembly described above, in which a button member 55i is surrounded by a ring member 552. Each of two hollow passages 51 through the button assembly 50 is defined by the gap formed between the button member 55i and the ring member 552. In some embodiments, gap has a shape, i.e., of a two-dimensional projection of the gap, emulating a sine curve 885 or parabolic curve 880 intercepted by the ring member, the emulating being accurate within ±10% at any given point of the curve within the respective gap. In some embodiments, the emulated sine curve or parabolic curve is characterized by, or can be drawn as having, arms defining an angle therebetween of between 40° and 80°. While the button assembly 50 shown in Fig. 33 is that of Fig. 3 A, it should be clear that the foregoing applies to the button assemblies 50 of Figs. 4A or 5 as well.

[0118] We now refer to Figs. 30A and 30B, which show a variant of the exemplary button assembly 50 illustrated in Figs. 3B and 3 A. In the example of Figs. 30A and 30B, the button member 55 is characterized by the presence of two ‘permanent’ holes 52. In this variant, the button member can be used as a conventional button that allows looping a thread through the permanent holes 52, which can require cutting the thread in order to remove the button 55; or as a button 55 according to embodiments disclosed herein, whereby the thread can be looped through the two hollow passages 51 formed between the button member and the ring member as in Figs. 21A-21B, which allows releasing the button without cutting the thread; or, by utilizing only one of the permanent holes 52 and tying a loop in manner of a one-hole button such as in Fig. 24 A. A decision as to which method of tying the thread can be made in the operating room, e.g., after a surgeon has assessed the options and made the decision in real-time.

[0119] The following paragraphs summarize, but not exhaustively, inventive concepts disclosed herein.

[0120] Inventive concept 1. A tissue-securing apparatus comprising: a. an anchor; b. one or more threads coupled to the anchor such that a plurality of thread ends extend proximally therefrom; and c. a button assembly comprising a plurality of button-assembly members arranged to completely surround, in combination, each of one or more respective hollow passages through the button assembly.

[0121] Inventive concept 2. The apparatus of Inventive concept 1, wherein at least one of the plurality of thread ends passes through a corresponding one of the one or more respective hollow passages.

[0122] Inventive concept 3. The apparatus of Inventive concept 2, wherein at least two of the plurality of thread ends are tied together to form a loop securing the button assembly to the anchor.Inventive concept 4. The apparatus of Inventive concept 3, wherein the button assembly is disengageable from the thread without cutting or breaking the thread.

[0123] Inventive concept 5. The apparatus of Inventive concept 3, wherein the button assembly is disengageable from the thread without cutting or breaking the thread by separating at least a first button-assembly member of the button assembly from at least one other button-assembly member.

[0124] Inventive concept 6. The apparatus of Inventive concept 3, wherein the button assembly is disengageable from the thread without cutting or breaking the thread by moving the at least a first button-assembly member relative to the at least one other button-assembly member.

[0125] Inventive concept 7. The apparatus of any one of the preceding Inventive concepts, operable to be assembled in an assembled state in which at least one of the plurality of thread ends passes through a corresponding one of the one or more respective hollow passages and at least two of the plurality of thread ends are tied together to form a loop securing the button assembly to the anchor.

[0126] Inventive concept 8. The apparatus of Inventive concept 7, wherein when in the assembled state the button assembly is non-destructively disengageable from the thread without cutting the thread by separating at least a first button-assembly member of the button assembly from at least one other button-assembly member.

[0127] Inventive concept 9. The apparatus of Inventive concept 7, wherein in the assembled state the button assembly is non-destructively disengageable from the thread without cutting the thread by moving the at least a first button-assembly member relative to the at least one other button-assembly member.

[0128] Inventive concept 10. The apparatus of any one of Inventive concepts 7 to 9, wherein the separating of the at least a first button-assembly member from the at least one other button-assembly member is effective to cause the one or more respective hollow passages to be no longer completely surrounded by the plurality of button-assembly members.

[0129] Inventive concept 11. The apparatus of any one of Inventive concepts 7 to 9, wherein in the assembled state the thread passes through exactly two hollow passages.

[0130] Inventive concept 12. The apparatus of Inventive concept 11, wherein the separating of the at least a first button-assembly member from the at least one other button-assembly member is effective to cause each of the two hollow passages to be no longer completely surrounded by the plurality of button-assembly members.

[0131] Inventive concept 13. The apparatus of any one of Inventive concepts 7 to 12, wherein a first button assembly -member of the button assembly comprises a peripheral member surrounding, in the assembled state, a peripheral edge of at least one other button-assembly member.

[0132] Inventive concept 14. The apparatus of Inventive concept 13, wherein the peripheral member comprises a ring member having a circular footprint or an elongated circular footprint.

[0133] Inventive concept 15. The button assembly of Inventive concept 14, wherein the at least one other buttonassembly member is at least partly circumscribed by a groove in the peripheral edge, and in the assembled state the peripheral member is at least partly seated in the groove.

[0134] Inventive concept 16. The button assembly of Inventive concept 15, wherein the peripheral member is sufficiently elastic to enter and depart the groove at least once without breaking, tearing or permanently deforming.

[0135] Inventive concept 17. The apparatus of any one of Inventive concepts 7 to 16, wherein when in the assembled state, the thread is directly engaged with a given button assembly -member of the button assembly such that the button assembly is non-destructively disengageable from the thread by the separating of the at least a first button-assembly member from the at least one other button-assembly member and another action involving the directly engaged given button-assembly member.Inventive concept 18. The apparatus of any one of the Inventive concepts 7 to 17, provided in the assembled state.

[0136] Inventive concept 19. A method of securing a tissue, the method comprising: a. Providing (i) an applicator comprising an elongated needle and (ii) the apparatus of any one of Inventive concepts 1 to 17; b. sequentially piercing a first tissue and penetrating a second tissue with a distal end of the elongated needle; c. ejecting the anchor out of a distal end of the elongated needle to cause a distal portion of the anchor to extend distally outward and into the second tissue; d. passing the at least one of the plurality of thread ends through the corresponding one of the one or more respective hollow passages; and e. tying at least two of the plurality of thread ends together to form the loop and secure the button assembly to the anchor.

[0137] Inventive concept 20. The method of Inventive concept 19, wherein the ejecting of the anchor causes the distal portion of the anchor to extend distally beyond the second tissue.

[0138] Inventive concept 21. The method of either one of Inventive concepts 19 or 20, wherein, after the tying, the button assembly is disposed proximal to the first tissue.

[0139] Inventive concept 22. The method of any one of Inventive concepts 19 to 21, wherein, after the tying, the button assembly is disposed in proximity to the first tissue.

[0140] Inventive concept 23. A method of retrieving the anchor of any one of Inventive concepts 5 to 17 from an in situ position in which at least a distal portion of the anchor is embedded in a tissue and the button assembly is not embedded in a tissue, the method comprising: a. disengaging the button assembly from the thread by separating the at least a first button-assembly member of the button assembly from the at least one other button-assembly member; b. engaging the loop of thread with a retrieval member; and c. withdrawing the retrieval member to extract at least the distal portion of anchor from the tissue to retrieve the anchor from the in situ position.

[0141] Inventive concept 24. The method of Inventive concept 23, additionally comprising, before the engaging: extracting one or more button-assembly members from direct engagement with the looped thread.

[0142] Inventive concept 25. The method of either one of Inventive concepts 23 or 24, wherein the retrieval member comprises a hook.

[0143] Inventive concept 26. The method of either one of Inventive concepts 23 or 24, wherein the retrieval member comprises a thread.

[0144] Inventive concept 27. The method of either one of Inventive concepts 23 or 24, wherein the retrieval member comprises a wire.

[0145] Inventive concept 28. An article of manufacture comprising the tissue-securing apparatus of any one of Inventive concepts 1 to 17 and a retrieval member comprising at least one of a hook, a thread and a wire.

[0146] Inventive concept 29. The article of manufacture of Inventive concept 28, not in an assembled state in which at least one of the plurality of thread ends passes through a corresponding one of the one or more respective hollow passages and at least two of the plurality of thread ends are tied together to form a loop securing the button assembly to the anchor.

[0147] Inventive concept 30. A button assembly for use in securing placement of a tissue anchor, the button assembly comprising a plurality of button-assembly members.

[0148] Inventive concept 31. The button assembly of Inventive concept 30, wherein when in a closed configuration the plurality of button-assembly members completely surround in combination each of one or more holes comprising respective hollow passages through the button assembly.

[0149] Inventive concept 32. The button assembly of either one of Inventive concepts 30 or 31, wherein when in a closed configuration defined by the plurality of button-assembly members completely surrounding in combinationeach of one or more holes comprising respective hollow passages through the button assembly, at least a first button-assembly member is non-destructively separable from at least one other button-assembly member so as to cause the one or more holes to be not completely surrounded by the plurality of button-assembly members.

[0150] Inventive concept 33. The button assembly of either one of Inventive concepts 30 or 31, wherein when in a closed configuration defined by the plurality of button-assembly members completely surrounding in combination each of one or more holes comprising respective hollow passages through the button assembly, at least a first button-assembly member non-destructively movable relative to at least one other button-assembly member so as to cause the one or more holes to be not completely surrounded by the plurality of button-assembly members.

[0151] Inventive concept 34. The button assembly of Inventive concept 33, wherein the at least a first buttonassembly member is movable relative to at least one other button-assembly member by moving or extending along a peripheral path, or by pivoting.

[0152] Inventive concept 35. The button assembly of any one of Inventive concepts 31 to 33, wherein when not in the closed configuration, at least a first button-assembly member is reversibly joinable to at least one other buttonassembly member to form and surround, in combination with the at least one other button-assembly member, each of the one or more holes.

[0153] Inventive concept 36. The button assembly of any one of Inventive concepts 31 to 34, wherein when not in the closed configuration, at least a first button-assembly member is movable relative to at least one other buttonassembly member to form and surround, in combination with the at least one other button-assembly member, each of the one or more holes.

[0154] Inventive concept 37. The button assembly of any one of Inventive concepts 30 to 36, wherein when not in the closed configuration, there is no hole comprising a hollow passage through the button assembly.

[0155] Inventive concept 38. The button assembly of any one of Inventive concepts 31 to 37, wherein the one or more holes comprise exactly one hole.

[0156] Inventive concept 39. The button assembly of any one of Inventive concepts 31 to 37, wherein the one or more holes comprise exactly two holes.

[0157] Inventive concept 40. An apparatus comprising: a. an anchor; b. one or more threads coupled to the anchor such that a plurality of thread ends extend proximally therefrom; and c. the button assembly of any one of Inventive concepts 31 to 39, in the closed configuration.

[0158] Inventive concept 41. A button assembly for use in securing placement of a tissue anchor, the button assembly comprising: a. a button characterized by two opposing major surfaces, each major surface having two rounded and / or broad portions displaced from each other in a longitudinal direction and joined by an intervening narrow portion; and b. a ring member having a circular footprint or an elongated circular footprint.

[0159] Inventive concept 42. The button assembly of Inventive concept 41, wherein when the button assembly is in a closed state, the ring member surrounds a peripheral edge of the button.

[0160] Inventive concept 43. The button assembly of either one of Inventive concepts 41 or 42, wherein when the button assembly is in a closed state: the ring member surrounds a peripheral edge of the button, and one or more gaps between the narrow portion and the ring member define respective hollow passages through the button assembly.

[0161] Inventive concept 44. The button assembly of either one of Inventive concepts 41 or 42, wherein when the button assembly is in a closed state in which the ring member surrounds a peripheral edge of the button, the ring member is non-destructively separable from the button.Inventive concept 45. The button assembly of either one of Inventive concepts 41 or 42, wherein, when the button assembly is in a closed state in which the ring member surrounds a peripheral edge of the button: one or more gaps between the narrow portion and the ring member define respective hollow passages through the button assembly, and the ring member is non-destructively separable from the button.

[0162] Inventive concept 46. The button assembly of any one of Inventive concepts 42 to 45, wherein when in the closed state, at least 30% of an arc length of the ring member is in physical contact with the button.

[0163] Inventive concept 47. The button assembly of any one of Inventive concepts 42 to 45, wherein when in the closed state, at least 50% of an arc length of the ring member is in physical contact with the button.

[0164] Inventive concept 48. The button assembly of any one of Inventive concepts 42 to 45, wherein when in the closed state, at least 70% of an arc length of the ring member is in physical contact with the button.

[0165] Inventive concept 49. The button assembly of any one of Inventive concepts 42 to 48, wherein when in the closed state, no more than 70% of a circumference of the ring member is in physical contact with the button.

[0166] Inventive concept 50. The button assembly of any one of Inventive concepts 42 to 48, wherein when in the closed state, no more than 80% of the ring member is in physical contact with the button.

[0167] Inventive concept 51. The button assembly of any one of Inventive concepts 42 to 45, wherein when in the closed state, no more than 90% of a circumference of the ring member is in physical contact with the button.

[0168] Inventive concept 52. The button assembly of any one of Inventive concepts 42 to 51, wherein when in the closed state, at least 30% of the peripheral edge of the button is in physical contact with the ring member.

[0169] Inventive concept 53. The button assembly of any one of Inventive concepts 42 to 51 , wherein when in the closed state, at least 50% of the peripheral edge of the button is in physical contact with the ring member.

[0170] Inventive concept 54. The button assembly of any one of Inventive concepts 42 to 53, wherein when in the assembled state, the one or more gaps comprise two opposing gaps.

[0171] Inventive concept 55. The button assembly of any one of Inventive concepts 42 to 53, each of the one or more gaps has a shape emulating a sine curve or parabolic curve intercepted by the ring member, the emulating being accurate within ±10% at any given point of the curve within the respective gap.

[0172] Inventive concept 56. The button assembly of Inventive concept 55, wherein the emulated sine curve or parabolic curve is characterized by arms defining an angle therebetween of between 40° and 80°.

[0173] Inventive concept 57. The button assembly of any one of Inventive concepts 42 to 56, wherein when in an operative state in which a respective thread segment passes through each of the one or more gaps between the narrow portion and the ring member, the ring member is effective to constrain lateral displacement of the thread segments.

[0174] Inventive concept 58. The button assembly of any one of Inventive concepts 42 to 57, wherein the button is at least partly circumscribed by a groove in the peripheral edge, and in the assembled state the ring member is at least partly seated in the groove.

[0175] Inventive concept 59. The button assembly of Inventive concept 58, wherein the ring member is sufficiently elastic to enter and depart the groove at least once without breaking, tearing or permanently deforming.

[0176] Inventive concept 60. The button assembly of any one of Inventive concepts 41 to 56, wherein the ring member includes a snap closure mechanism.

[0177] Inventive concept 61. The button assembly of any one of Inventive concepts 41 to 60, wherein the ring member is reversibly and non-destructively separable into a plurality of ring-member parts.Inventive concept 62. A tissue-securing apparatus comprising: a. an anchor; b. one or more threads coupled to the anchor such that a plurality of thread ends extend proximally therefrom; and c. the button assembly of any one of Inventive concepts 42 to 61, in the closed state.

[0178] Inventive concept 63. The tissue-securing apparatus of Inventive concept 62, wherein when in an assembled state of the tissue-securing apparatus, at least one of the plurality of thread ends passes through a corresponding one of the one or more gaps, and at least two of the plurality of thread ends are tied together to form a loop securing the button assembly to the anchor.

[0179] Inventive concept 64. The tissue-securing apparatus of either one of Inventive concepts 62 or 63, wherein when in an assembled state of the tissue-securing apparatus, in which (i) at least one of the plurality of thread ends passes through a corresponding one of the one or more gaps, and (ii) at least two of the plurality of thread ends are tied together to form a loop securing the button assembly to the anchor, the button assembly is disengageable from the thread without cutting the thread by separating the ring member from the button.

[0180] Inventive concept 65. The tissue-securing apparatus of either one of Inventive concepts 63 or 64, wherein when in the assembled state of the tissue-securing apparatus, the button assembly is disengageable from the thread without cutting the thread.

[0181] Inventive concept 66. The tissue-securing apparatus of any one of Inventive concepts 63 to 65, wherein when in the assembled state of the tissue-securing apparatus, the button assembly is disengageable from the thread by non-destructively separating the ring member from the button.

[0182] Inventive concept 67. A method of securing a tissue, the method comprising: a. providing (i) an applicator comprising an elongated needle and (ii) the tissue-securing apparatus of any one of Inventive concepts 62 to 66; b. sequentially piercing a first tissue and penetrating a second tissue with a distal end of the elongated needle; c. ejecting the anchor out of a distal end of the elongated needle to cause a distal portion of the anchor to extend distally outward and into the second tissue; d. passing the at least one of the plurality of thread ends through the corresponding one of the one or more respective gaps; e. positioning the button assembly to be proximal to the first tissue and in proximity thereto; and f. tying at least two of the plurality of thread ends together to form the loop and secure the button assembly to the anchor.

[0183] Inventive concept 68. The method of Inventive concept 67, wherein ejecting the anchor causes the distal portion of the anchor to extend distally beyond the second tissue

[0184] Inventive concept 69. The method of either one of Inventive concepts 67 or 68, wherein the forming of the loop is effective to prevent movement of said anchor in at least one direction.

[0185] Inventive concept 70. A method of retrieving the anchor of either one of the tissue-securing apparatus of any one of Inventive concepts 62 to 66 from an in situ position in which at least a distal portion of the anchor is embedded in a tissue and the button assembly is not embedded in a tissue, the method comprising: a. separating the ring member from the button; b. engaging the loop of thread with a retrieval member; and c. withdrawing the retrieval member to extract at least the distal portion of anchor from the tissue to retrieve the anchor from the in situ position.

[0186] Inventive concept 71. The method of Inventive concept 70, wherein the retrieval member comprises a hook.

[0187] Inventive concept 72. The method of Inventive concept 70, wherein the retrieval member comprises a thread.

[0188] Inventive concept 73. The method of Inventive concept 70, wherein the retrieval member comprises a wire.Inventive concept 74. An article of manufacture comprising the tissue-securing apparatus of any one of Inventive concepts, not in the assembled state, and a retrieval member comprising at least one of a hook, a thread and a wire.

[0189] Inventive concept 75. A button for use in securing placement of a tissue anchor, the button comprising two opposing major surfaces, each major surface having two rounded broad portions displaced from each other in a longitudinal direction and joined by an intervening narrow portion.

[0190] Inventive concept 75.1. The button of Inventive concept 75, wherein: the narrow portion has a minimum width in a transverse direction equal to between 33% and 67% of a respective maximum width in the transverse direction of each of the rounded broad portions.

[0191] Inventive concept 75.2. The button of either one of Inventive concepts 75 or 75.1, wherein travel between any two points along a peripheral edge between an endpoint of a line segment defining the minimum width and a nearest endpoint of a line segment defining the maximum width includes longitudinal movement in a single longitudinal direction.

[0192] Inventive concept 76. The button of Inventive concept 75, wherein each of the rounded broad portions has a shape emulating a two-dimensional projection of an oblate spheroid, the emulating being accurate within ±10% at any given circumferential point.

[0193] Inventive concept 77. The button of Inventive concept 75, wherein each of the rounded broad portions has a shape emulating a two-dimensional projection of an ellipsoid, the emulating being accurate within ±10% at any given circumferential point.

[0194] Inventive concept 78. The button assembly of any one of Inventive concepts 75 to 77, wherein the narrow portion has a shape emulating a Joachimsthal tetracuspid, the emulating being accurate within ±10% at any peripheral point.

[0195] Inventive concept 79. A button assembly for use in securing placement of a tissue anchor, comprising: a. a button according to any one of Inventive concepts 75 to 78; and b. a ring member having a circular shape or an elongated circular shape.

[0196] Inventive concept 80. The button assembly of Inventive concept 79, in a closed state in which the ring member surrounds a peripheral edge of the button.

[0197] Inventive concept 81. The button assembly of either one of Inventive concepts 79 or 80, wherein when the button assembly is in a closed state: the ring member surrounds a peripheral edge of the button, and one or more gaps between the narrow portion and the ring member define respective hollow passages through the button assembly.

[0198] Inventive concept 82. The button assembly of either one of Inventive concepts 79 or 80, wherein when the button assembly is in a closed state in which the ring member surrounds a peripheral edge of the button, the ring member is non-destructively separable from the button.

[0199] Inventive concept 83. The button assembly of either one of Inventive concepts 79 or 80, wherein, when the button assembly is in a closed state in which the ring member surrounds a peripheral edge of the button: one or more gaps between the narrow portion and the ring member define respective hollow passages through the button Inventive concept 84. A tissue-securing apparatus comprising: a. an anchor; b. one or more threads coupled to the anchor such that a plurality of thread ends extend proximally therefrom; and c. the button assembly of any one of Inventive concepts 80 to 83, in the closed state.

[0200] Inventive concept 85. The tissue-securing apparatus of Inventive concept 84, in an assembled state of the tissue-securing apparatus in which at least one of the plurality of thread ends passes through a corresponding one ofthe one or more gaps, and at least two of the plurality of thread ends are tied together to form a loop securing the button assembly to the anchor.

[0201] Inventive concept 86. The tissue-securing apparatus of either one of Inventive concepts 84 or 85, wherein when in an assembled state of the tissue-securing apparatus, in which (i) at least one of the plurality of thread ends passes through a corresponding one of the one or more gaps, and (ii) at least two of the plurality of thread ends are tied together to form a loop securing the button assembly to the anchor, the button assembly is disengageable from the thread without cutting the thread by separating the ring member from the button.

[0202] Inventive concept 87. The tissue-securing apparatus of either one of Inventive concepts 85 or 86, wherein when in the assembled state of the tissue-securing apparatus, the button assembly is disengageable from the thread without cutting the thread.

[0203] Inventive concept 88. The tissue-securing apparatus of any one of Inventive concepts 85 to 87, wherein when in the assembled state of the tissue-securing apparatus, the button assembly is disengageable from the thread by non-destructively separating the ring member from the button.

[0204] Inventive concept 89. A method of securing a tissue, the method comprising: a. Providing (i) an applicator comprising an elongated needle and (ii) the tissue-securing apparatus of any one of Inventive concepts 84 to 88; b. sequentially piercing a first tissue and penetrating a second tissue with a distal end of the elongated needle; c. ejecting the anchor out of a distal end of the elongated needle to cause a distal portion of the anchor to extend distally outward and into the second tissue; d. passing the at least one of the plurality of thread ends through the corresponding one of the one or more respective gaps; e. positioning the button assembly to be proximal to the first tissue and in proximity thereto; and f. tying at least two of the plurality of thread ends together to form the loop and secure the button assembly to the anchor.

[0205] Inventive concept 90. The method of Inventive concept 89, wherein the ejecting of the anchor causes the distal portion of the anchor to extend distally beyond the second tissue.

[0206] Inventive concept 91. The method of either one of Inventive concepts 89 or 90, wherein, after the tying, the button assembly is disposed proximal to the first tissue.

[0207] Inventive concept 92. The method of any one of Inventive concepts 89 to 91, wherein, after the tying, the button assembly is disposed in proximity to the first tissue.

[0208] Inventive concept 93. A method of retrieving the anchor of Inventive concept 45 from an in situ position in which at least a distal portion of the anchor is embedded in a tissue and the button assembly is not embedded in a tissue, the method comprising: a. separating the ring member from the button; b. engaging the loop of thread with a retrieval member; and c. withdrawing the retrieval member to extract at least the distal portion of anchor from the tissue to retrieve the anchor from the in situ position.

[0209] Inventive concept 94. The method of Inventive concept 93, wherein the retrieval member comprises a hook.

[0210] Inventive concept 95. The method of Inventive concept 93, wherein the retrieval member comprises a thread.

[0211] Inventive concept 96. The method of Inventive concept 93, wherein the retrieval member comprises a wire. Inventive concept 101. A tissue-securing apparatus comprising: a. an anchor; b. one or more threads coupled to the anchor such that a plurality of thread ends extend proximally therefrom; and c. a button assembly comprising a plurality of button-assembly members arranged to completely surround, in combination, each of one or more respective hollow passages through the button assembly, d. wherein when in an assembled state in which (i) at least one of the plurality of thread ends passes through a corresponding one of the one or more respective hollowpassages, and (ii) at least two of the plurality of thread ends are tied together to form a loop securing the button assembly to the anchor, the button assembly is disengageable from the thread without cutting the thread by separating at least a first button-assembly member of the button assembly from at least one other button-assembly member and / or by moving the at least a first button-assembly member relative to the at least one other buttonassembly member.

[0212] Inventive concept 102. The apparatus oflnventive concept 101, wherein in the assembled state the button assembly is non-destructively disengageable from the thread without cutting the thread by separating at least a first button-assembly member of the button assembly from at least one other button-assembly member and / or by moving the at least a first button-assembly member relative to the at least one other button-assembly member.

[0213] Inventive concept 103. The apparatus of either one oflnventive concepts 101 or 102, wherein the separating of the at least a first button-assembly member from the at least one other button-assembly member is effective to cause the one or more respective hollow passages to be no longer completely surrounded by the plurality of button-assembly members.

[0214] Inventive concept 104. The apparatus of any one of lnventive concepts 101 to 103, wherein in the assembled state the thread passes through exactly two hollow passages, and the separating of the at least a first button-assembly member from the at least one other button-assembly member is effective to cause each of the two hollow passages to be no longer completely surrounded by the plurality of button-assembly members.

[0215] Inventive concept 105. The apparatus of any one of Inventive concepts 101 to 104, wherein a first button assembly -member of the button assembly comprises a peripheral member surrounding, in the assembled state, a peripheral edge of at least one other button-assembly member.

[0216] Inventive concept 106. The apparatus oflnventive concept 105, wherein the peripheral member comprises a ring member having a circular footprint or an elongated circular footprint.

[0217] Inventive concept 107. The button assembly of Inventive concepts 106, wherein the at least one other button-assembly member is at least partly circumscribed by a groove in the peripheral edge, and in the assembled state the ring member is at least partly seated in the groove, and (ii) the ring member is sufficiently elastic to enter and depart the groove at least once without breaking, tearing or permanently deforming.

[0218] Inventive concept 108. The apparatus of any one of Inventive concepts 101 to 106, wherein when in the assembled state, the thread is directly engaged with a given button assembly -member of the button assembly such that the button assembly is non-destructively disengageable from the thread by the separating of the at least a first button-assembly member from the at least one other button-assembly member and another action involving the directly engaged button-assembly member.

[0219] Inventive concept 109. The apparatus of any one of Inventive concepts 101 to 107, in the assembled state. Inventive concept 110. The apparatus of any one oflnventive concepts 101 to 107, at least one of the plurality of thread ends passing through a corresponding one of the one or more respective hollow passages.

[0220] Inventive concept 111. A method of securing a tissue, the method comprising: a. providing (i) an applicator comprising an elongated needle and (ii) the apparatus of any one oflnventive concepts 101 to 107; b. sequentially piercing a first tissue and penetrating a second tissue with a distal end of the elongated needle; c. ejecting the anchor out of the distal end of the elongated needle to cause a distal portion of the anchor to extend distally outward and into or beyond the second tissue; d. passing the at least one of the plurality of thread ends through the corresponding one of the one or more respective hollow passages; and e. tying at least two of the plurality of thread ends together to form the loop and secure the button assembly to the anchor.Inventive concept 112. The method of Inventive concept 111, wherein, after the tying, the button assembly is disposed proximal to the first tissue and in proximity thereto.

[0221] Inventive concept 113. A method of retrieving the anchor of the tissue-securing apparatus of any one of Inventive concepts 101 to 109 from an in situ position in which at least a distal portion of the anchor is embedded in a tissue and the button assembly is not embedded in a tissue, the method comprising: a. disengaging the button assembly from the thread by separating the at least a first button-assembly member of the button assembly from the at least one other button-assembly member; b. engaging the loop of thread with a retrieval member; and c. withdrawing the retrieval member to extract at least a proximal portion of the anchor from the tissue to retrieve the anchor from the in situ position.

[0222] Inventive concept 114. The method of Inventive concept 113, wherein the retrieval member comprises a hook.

[0223] Inventive concept 115. The method of Inventive concept 113, wherein the retrieval member comprises at least one of a thread and a wire.

[0224] Inventive concept 116. An article of manufacture comprising the tissue-securing apparatus of any one of Inventive concept 101 to 107, not in the assembled state, and a retrieval member comprising at least one of a hook, a thread and a wire.

[0225] Inventive concept 117. A button assembly for use in securing placement of a tissue anchor, the button assembly comprising a plurality of button-assembly members, wherein when in a closed configuration defined by the plurality of button-assembly members completely surrounding in combination each of one or more holes comprising respective hollow passages through the button assembly, at least a first button-assembly member is non-destmctively movable relative to, and / or non-destructively separable from, at least one other button-assembly member so as to cause the one or more holes to be not completely surrounded by the plurality of button-assembly members.

[0226] Inventive concept 118. The button assembly of Inventive concept 117, wherein the at least a first buttonassembly member is movable relative to at least one other button-assembly member by moving or extending along a peripheral path, or by pivoting.

[0227] Inventive concept 119. The button assembly of either one of Inventive concepts 117 or 118, wherein when not in the closed configuration, at least a first button-assembly member is movable relative to, and / or reversibly joinable to, at least one other button-assembly member to form and surround, in combination with the at least one other button-assembly member, each of the one or more holes.

[0228] Inventive concept 120. The button assembly of any one of Inventive concepts 117 to 119, wherein when not in the closed configuration, there is no hole comprising a hollow passage through the button assembly.

[0229] Inventive concept 121. The button assembly of any one of Inventive concepts 117 to 120, wherein the one or more holes comprise exactly one hole.

[0230] Inventive concept 122. The button assembly of any one of Inventive concepts 117 to 121, wherein the one or more holes comprise exactly two holes.

[0231] Inventive concept 123. An apparatus comprising: a. an anchor; b. one or more threads coupled to the anchor such that a plurality of thread ends extend proximally therefrom; and c. the button assembly of any one of Inventive concepts 117 to 122, in the closed configuration.

[0232] Inventive concept 124. A button assembly for use in securing placement of a tissue anchor, the button assembly comprising: a. a button characterized by two opposing major surfaces, each major surface having two rounded and / or broad portions displaced from each other in a longitudinal direction and joined by an interveningnarrow portion; and b. a ring member having a circular footprint or an elongated circular footprint, wherein, when the button assembly is in an assembled state in which the ring member surrounds a peripheral edge of the button: one or more gaps between the narrow portion and the ring member define respective hollow passages through the button assembly, and the ring member is non-destructively separable from the button.

[0233] Inventive concept 124A. The button assembly of Inventive concept 124, wherein the button comprises one or more hollow passages therethrough, the one or more hollow passages each peripherally surrounded by the button.

[0234] Inventive concept 125. The button assembly of either one of Inventive concepts 124 or 124A, wherein when in the assembled state, at least 30%, or at least 50%, of an arc length of the ring member is in physical contact with the button.

[0235] Inventive concept 126. The button assembly of any one of Inventive concepts 124 to 125, wherein when in the assembled state, no more than 90%, or no more than 80%, or no more than 70% of a circumference of the ring member is in physical contact with the button.

[0236] Inventive concept 127. The button assembly of any one of Inventive concepts 124 to 126, wherein when in the assembled state, at least 30%, or at least 50%, of the peripheral edge of the button is in physical contact with the ring member.

[0237] Inventive concept 128. The button assembly of any one of Inventive concepts 124 to 127, wherein when in the assembled state, the one or more gaps comprise two opposing gaps, each gap having a shape emulating a sine curve or parabolic curve intercepted by the ring member, the emulating being accurate within ±10% at any given point of the curve within the respective gap.

[0238] Inventive concept 129. The button assembly of Inventive concept 128, wherein the emulated sine curve or parabolic curve is characterized by arms defining an angle therebetween of between 40° and 80°.

[0239] Inventive concept 130. The button assembly of any one of Inventive concepts 124 to 129, wherein when in an operative state in which a respective thread segment passes through each of the one or more gaps between the narrow portion and the ring member, the ring member is effective to constrain lateral displacement of the thread segments.

[0240] Inventive concept 131. The button assembly of any one of Inventive concepts 124 to 130, wherein (i) the button is at least partly circumscribed by a groove in the peripheral edge, and in the assembled state the ring member is at least partly seated in the groove, and (ii) the ring member is sufficiently elastic to enter and depart the groove at least once without breaking, tearing or permanently deforming.

[0241] Inventive concept 132. The button assembly of any one of Inventive concepts 124 to 130, wherein the ring member includes a snap closure mechanism.

[0242] Inventive concept 133. The button assembly of any one of Inventive concepts 124 to 132, wherein the ring member is reversibly and non-destructively separable into a plurality of ring-member parts.

[0243] Inventive concept 134. A tissue-securing apparatus comprising: a. an anchor; b. one or more threads coupled to the anchor such that a plurality of thread ends extend proximally therefrom; and c. the button assembly of any one of Inventive concepts 124 to 133, in the closed state, wherein when in an assembled state of the tissuesecuring apparatus in which (i) at least one of the plurality of thread ends passes through a corresponding one of the one or more gaps, and (ii) at least two of the plurality of thread ends are tied together to form a loop securing the button assembly to the anchor, the button assembly is disengageable from the thread without cutting the thread by separating the ring member from the button.Inventive concept 135. The tissue-securing apparatus of Inventive concept 134, wherein when in the assembled state of the tissue-securing apparatus, the button assembly is disengageable from the thread by non-destmctively separating the ring member from the button without cutting the thread.

[0244] Inventive concept 136. A method of securing a tissue, the method comprising: a. providing (i) an applicator comprising an elongated needle and (ii) the apparatus of either one of Inventive concepts 134 or l35; b. sequentially piercing a first tissue and penetrating a second tissue with a distal end of the elongated needle; c. ejecting the anchor out of the distal end of the elongated needle to cause a distal portion of the anchor to extend distally outward and into or beyond the second tissue; d. passing the at least one of the plurality of thread ends through the corresponding one of the one or more respective gaps; e. positioning the button assembly to be proximal to the first tissue and in proximity thereto; and f. tying at least two of the plurality of thread ends together to form the loop and secure the button assembly to the anchor.

[0245] Inventive concept 137. The method of Inventive concept 136, wherein the forming of the loop is effective to prevent movement of said anchor in at least one direction.

[0246] Inventive concept 138. A method of retrieving the anchor of the tissue-securing apparatus of either one of Inventive concepts 134 or 135 from an in situ position in which at least a distal portion of the anchor is embedded in a tissue and the button assembly is not embedded in a tissue, the method comprising: a. separating the ring member from the button; b. engaging the loop of thread with a retrieval member; and c. withdrawing the retrieval member to extract at least a proximal portion of anchor from the tissue to retrieve the anchor from the in situ position.

[0247] Inventive concept 139. The method of Inventive concept 138, wherein the retrieval member comprises at least one of a hook, a thread and a wire.

[0248] Inventive concept 140. An article of manufacture comprising the tissue-securing apparatus of either one of Inventive concepts 134 or 135, not in the assembled state, and a retrieval member comprising at least one of a hook, a thread and a wire.

[0249] Inventive concept 141. A button for use in securing placement of a tissue anchor, the button comprising two opposing major surfaces, each major surface having two rounded broad portions displaced from each other in a longitudinal direction and joined by an intervening narrow portion, wherein: i. the narrow portion has a minimum width in a transverse direction equal to between 33% and 67% of a respective maximum width in the transverse direction of each of the rounded broad portions, and ii. travel between any two points along a peripheral edge between an endpoint of a line segment defining the minimum width and a nearest endpoint of a line segment defining the maximum width includes longitudinal movement in a single longitudinal direction.

[0250] Inventive concept 142. The button of Inventive concept 141, wherein each of the rounded broad portions has a shape emulating a two-dimensional projection of an oblate spheroid or ellipsoid, the emulating being accurate within ±10% at any given circumferential point.

[0251] Inventive concept 143. The button assembly of either one of Inventive concepts 141 or 142, wherein the narrow portion has a shape emulating a Joachimsthal tetracuspid, the emulating being accurate within ±10% at any peripheral point.

[0252] Inventive concept 144. A button assembly for use in securing placement of a tissue anchor, comprising: Inventive concept 145. a button according to any one of Inventive concepts 141 to 143; and Inventive concept 146. a ring member having a circular shape or an elongated circular shape, wherein, when the button assembly is in a closed state in which the ring member surrounds a peripheral edge of the button, one or more gaps between the narrow portion and the ring member define respective hollow passages through the button assembly.Inventive concept 147. The button assembly of Inventive concept 144, wherein the ring member is non-destmctively separable from the button.

[0253] Inventive concept 148. A tissue-securing apparatus comprising: a. an anchor; b. one or more threads coupled to the anchor such that a plurality of thread ends extend proximally therefrom; and c. the button assembly of either one of Inventive concepts 144 or 145, in the closed state, wherein when in an assembled state of the tissuesecuring apparatus in which (i) at least one of the plurality of thread ends passes through a corresponding one of the one or more gaps, and (ii) at least two of the plurality of thread ends are tied together to form a loop securing the button assembly to the anchor, the button assembly is disengageable from the thread without cutting the thread by separating the ring member from the button.

[0254] Inventive concept 149. A method of securing a tissue, the method comprising: a. providing (i) an applicator comprising an elongated needle and (ii) the tissue-securing apparatus of Inventive concept 148; b. sequentially piercing a first tissue and penetrating a second tissue with a distal end of the elongated needle; c. ejecting the anchor out of the distal end of the elongated needle to cause a distal portion of the anchor to extend distally outward and into or beyond the second tissue; d. passing the at least one of the plurality of thread ends through the corresponding one of the one or more respective gaps; e. positioning the button assembly to be proximal to the first tissue and in proximity thereto; and f. tying at least two of the plurality of thread ends together to form the loop and secure the button assembly to the anchor.

[0255] Inventive concept 150. A method of retrieving the anchor of the tissue-securing apparatus of Inventive concept 148 from an in situ position in which at least a distal portion of the anchor is embedded in a tissue and the button assembly is not embedded in a tissue, the method comprising: a. separating the ring member from the button; b. engaging the loop of thread with a retrieval member; and c. withdrawing the retrieval member to extract at least a proximal portion of anchor from the tissue to retrieve the anchor from the in situ position.

[0256] Any of the foregoing inventive concepts can be combined with any one or more other inventive concepts within the scope of the disclosed embodiments.

[0257] The present invention has been described using detailed descriptions of embodiments thereof that are provided by way of example and are not intended to limit the scope of the invention. The described embodiments comprise different features, not all of which are required in all embodiments of the invention. Some embodiments of the present invention utilize only some of the features or possible combinations of the features. Variations of embodiments of the present invention that are described and embodiments of the present invention comprising different combinations of features noted in the described embodiments will occur to persons skilled in the art to which the invention pertains.

Claims

CLAIMS1. A button assembly for use in securing placement of a tissue anchor, the button assembly comprising: a. a button characterized by two opposing major surfaces, each major surface having two rounded and / or broad portions displaced from each other in a longitudinal direction and joined by an intervening narrow portion; andb. a ring member having a circular footprint or an elongated circular footprint,wherein, when the button assembly is in an assembled state in which the ring member surrounds a peripheral edge of the button: one or more gaps between the narrow portion and the ring member define respective hollow passages through the button assembly.

2. The button assembly of claim 1, wherein when the button assembly is in the assembled state, the ring member is non-destructively separable from the button.

3. The button assembly of either one of claims 1 or 2, wherein when in an operative state in which a respective thread segment passes through each of the one or more gaps between the narrow portion and the ring member, the ring member is effective to constrain lateral displacement of the thread segments.

4. The button assembly of any one of the preceding claims, wherein (i) the button is at least partly circumscribed by a groove in the peripheral edge, and in the assembled state the ring member is at least partly seated in the groove, and (ii) the ring member is sufficiently elastic to enter and depart the groove at least once without breaking, tearing or permanently deforming.

5. The button assembly of any one of claims 1 to 3, wherein the ring member includes a snap closure mechanism.

6. The button assembly of any one of the preceding claims, wherein the ring member is reversibly and non- destructively separable into a plurality of ring-member parts.

7. The button assembly of any one of the preceding claims, wherein when in the assembled state, at least 30% of an arc length of the ring member is in physical contact with the button.

8. The button assembly of any one of the preceding claims, wherein when in the assembled state, at least 50% of an arc length of the ring member is in physical contact with the button.

9. The button assembly of any one of the preceding claims, wherein when in the assembled state no more than 90% of a circumference of the ring member is in physical contact with the button.

10. The button assembly of any one of the preceding claims, wherein when in the assembled state no more than 70% of a circumference of the ring member is in physical contact with the button.

11. The button assembly of any one of the preceding claims, wherein when in the assembled state, at least 30% of the peripheral edge of the button is in physical contact with the ring member.

12. The button assembly of any one of the preceding claims, wherein when in the assembled state, at least 50%, of the peripheral edge of the button is in physical contact with the ring member.

13. The button assembly of any one of the preceding claims, wherein when in the assembled state, the one or more gaps comprise two opposing gaps, each gap having a shape emulating a sine curve or parabolic curve intercepted by the ring member, the emulating being accurate within ±10% at any given point of the curve within the respective gap.

14. The button assembly of claim 13, wherein the emulated sine curve or parabolic curve is characterized by arms defining an angle therebetween of between 40° and 80°.

15. The button assembly of any one of the previous claims, wherein:i. the narrow portion of the button has a minimum width in a transverse direction equal to between 33% and 67% of a respective maximum width in the transverse direction of each of the rounded broad portions, andii. travel between any two points along the peripheral edge of the button between an endpoint of a line segment defining the minimum width and a nearest endpoint of a line segment defining the maximum width includes longitudinal movement in a single longitudinal direction and precludes longitudinal movement in a different longitudinal direction.

16. The button assembly of claim 15, wherein each of the rounded broad portions has a shape emulating a two- dimensional projection of an oblate spheroid or ellipsoid, the emulating being accurate within ±10% at any given circumferential point.

17. The button assembly of either one of claims 15 or 16, wherein the narrow portion has a shape emulating a Joachimsthal tetracuspid, the emulating being accurate within ±10% at any peripheral point.

18. A tissue-securing apparatus comprising:a. an anchor;b. one or more threads coupled to the anchor such that a plurality of thread ends extend proximally therefrom; andc. the button assembly of any one of the preceding claims, in the assembled state thereof, wherein when in an assembled state of the tissue-securing apparatus in which (i) at least one of the plurality of thread ends passes through a corresponding one of the one or more gaps, and (ii) at least two of the plurality of thread ends are tied together to form a loop securing the button assembly to the anchor, the button assembly is disengageable from the thread without cutting the thread by separating the ring member from the button.

19. The tissue-securing apparatus of claim 18, wherein when in the assembled state of the tissue-securing apparatus, the button assembly is disengageable from the thread by non-destructively separating the ring member from the button without cutting the thread.

20. An article of manufacture comprising the tissue-securing apparatus of either one of claims 18 or 19, not in the assembled state thereof, and a retrieval member comprising at least one of a hook, a thread and a wire.

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