Anchoring and locking members of a percutaneous valve implant

Abstract

An apparatus includes a filament (58) and a tissue anchor (60) coupled to the filament. The anchor includes a proximal portion (60p), a distal portion (60d), and a plurality of bands (84) that couple the proximal portion to the distal portion, the proximal portion being shaped to define one or more appendages (82). The anchor is configured to anchor the filament at tissue (42) of a subject by means of radially deployed appendages, and when a radial constraining force is removed from the anchor, the bands radially deploy to form corresponding loops distally of the tissue. Other embodiments are also described.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Provisional Application No. 62 / 791,912, filed on January 14, 2019, entitled “Transecatheter ring and valve system,” the disclosure of which is incorporated herein by reference. Field of the Invention

[0003] Embodiments of the present invention relate generally to the field of medical devices, and more particularly to apparatus and methods for percutaneous valve repair and replacement.

[0004] background

[0005] In some subjects, the implant may be used to repair or replace a valve within the heart.

[0006] Bar et al., U.S. Pat. No. 10,278,820, the disclosure of which is incorporated herein by reference, describes a device comprising an assembly of tubes, each tube being shaped to define a lumen, the device further comprising a plurality of tissue anchors, an expandable annular structure, and a plurality of control wires, each tissue anchor being disposed within a corresponding lumen; the expandable annular structure comprising a plurality of teeth coupled to the tube assembly; and a plurality of control wires coupled to the annular structure, configured to position the tubes by manipulating the annular structure so as to deploy the tissue anchors from the lumen.

[0007] U.S. Patent Application 10,463,486 to Bar et al. describes a device comprising a plurality of flexible tube guides, an assembly of annular tubes, a plurality of threads, and an expandable annular structure, each tube being slidably disposed within a corresponding one of the tube guides; each thread comprising a distal end carried by a corresponding one of the tubes; the expandable annular structure being coupled to the tube guides, the expandable annular structure being configured to deploy the assembly of tubes from a folded configuration on tissue of a subject by radially outwardly moving the tube guides. The device also includes a plurality of control wires coupled to the tube guides, which are configured to position the tubes after the assembly is deployed, for deploying the threads from the tubes and into the tissue by bending the tube guides. SUMMARY OF THE INVENTION

[0009] According to some embodiments of the present invention, a device is provided, which includes a thread and a tissue anchor coupled to the thread. The tissue anchor includes a proximal portion, a distal portion, and a plurality of strips coupling the proximal portion to the distal portion, the proximal portion being shaped to define one or more appendages. The anchor is configured to anchor the thread at the tissue of a subject by means of radially expanded appendages, and when the radial restraining force is removed from the anchor, the strips radially expand to form a corresponding loop at the distal side of the tissue.

[0010] In some embodiments, the strip is configured to unfold such that the loop is arranged in a circular formation.

[0011] In some embodiments, the attachment includes corresponding tines.

[0012] In some embodiments, the thread at least partially passes through the anchor.

[0013] In some embodiments, the anchor is coupled to the thread by means of a knot in the thread distal to the anchor.

[0014] In some embodiments, the anchor is coupled to the wire by means of the wire being attached to a distal portion of the anchor.

[0015] In some embodiments, the strips include 2-8 strips.

[0016] In some embodiments, for each of the straps, the circumferential angle between the proximal end of the strap and the distal end of the strap is at least 5 degrees.

[0017] In some embodiments, the circumferential angle is between 10 degrees and 30 degrees.

[0018] In some embodiments, the proximal portion of the anchor is shaped to define the appendage by virtue of being shaped to define a corresponding recess beneath the appendage.

[0019] In some embodiments, the appendage does not extend radially beyond any other portion of the anchor prior to removal of the restraining force.

[0020] In some embodiments, as the appendages are deployed, the angle between each appendage and the longitudinal axis of the proximal portion of the anchor is between 5 degrees and 60 degrees.

[0021] According to some embodiments of the present invention, a method for anchoring a thread on a subject's tissue is also provided. The method includes delivering a tissue anchor to the tissue, the tissue anchor being radially constrained within a tube and coupled to the thread. The method also includes passing the tube through the tissue, and after passing the tube through the tissue, pushing the anchor from the tube so that one or more appendages at the proximal portion of the anchor radially expand, and a plurality of strips radially expand to form corresponding loops at the distal side of the tissue, the plurality of strips coupling the proximal portion of the anchor to the distal portion of the anchor.

[0022] In some embodiments, pushing the anchor from the tube includes pushing the anchor from the tube such that the appendage is deployed proximal to the tissue.

[0023] In some embodiments, pushing the anchor from the tube includes pushing the anchor from the tube such that the appendage is deployed within the tissue.

[0024] In some embodiments, the thread passes through the anchor.

[0025] In some embodiments, the anchor is coupled to the thread by means of a knot in the thread distal to the anchor.

[0026] According to some embodiments of the present invention, there is also provided a device configured to lock an implant in vivo on a thread passing through the implant. The device includes a locking body configured to be advanced to the implant on the thread, and includes at least one rotatable element, the locking body configured to clamp the thread proximally at the implant when the rotatable element rotates. The device also includes a rotation retaining element configured to inhibit the reversal of the rotation of the rotatable element by engaging with the locking body.

[0027] In some embodiments, the locking body includes a serrated surface, and the locking body is configured to clamp the wire using the serrated surface.

[0028] In some embodiments, the rotatable element comprises a serrated surface.

[0029] In some embodiments, the locking body further comprises a block, and the locking body is configured to clamp the wire between the rotatable element and the block.

[0030] In some embodiments,

[0031] The block is shaped to define a recess,

[0032] The rotatable element is shaped to define a protrusion configured to fit into the recess when the rotatable element rotates, and

[0033] The locking body is configured to clamp the wire between the protrusion and the recess.

[0034] In some embodiments, the at least one rotatable element includes a pair of opposing rotatable elements, and the locking body is configured to clamp the wire between the pair of opposing rotatable elements.

[0035] In some embodiments, the rotation retaining element includes a ring configured to cause the rotatable element to rotate by fitting over the locking body and inhibit reversal of the rotation.

[0036] In some embodiments, the locking body is shaped to define one or more notches, and the ring is shaped to define corresponding tabs that are configured to fit into the notches.

[0037] In some embodiments, the ring is configured to cause the rotatable element to rotate by fitting over the rotatable element.

[0038] In some embodiments, the apparatus further comprises:

[0039] a hollow outer longitudinal element configured to push the ring onto the rotatable element; and

[0040] A hollow inner longitudinal element is configured to advance the locking body over the wire as the wire passes through the inner longitudinal element and the inner longitudinal element passes through the outer longitudinal element before the ring is pushed onto the rotatable element.

[0041] In some embodiments,

[0042] The inner longitudinal member is shaped to define a bore, and

[0043] The ring is shaped to define a tab configured to fit into the aperture when the locking body is advanced over the wire.

[0044] In some embodiments, the inner longitudinal element comprises a sharp distal edge configured to cut the wire after the ring is pushed onto the rotatable element.

[0045] In some embodiments, the locking body further comprises a shaft disposed beside the rotatable element, and the ring is configured to cause the rotatable element to rotate by fitting on the shaft such that the ring pushes the rotatable element.

[0046] In some embodiments,

[0047] The shaft is shaped to define an inclined groove,

[0048] The locking body also includes:

[0049] a first pin coupled to the rotatable element and passing through the groove;

[0050] Blocks; and

[0051] a second pin that passes through the rotatable element and through the block, the rotatable element being configured to rotate relative to the second pin, and

[0052] Since the movement of the first pin is constrained by the groove, the ring is configured to cause the block to be pulled toward the shaft by rotating the rotatable element so that the locking body clamps the wire between the block and the shaft.

[0053] In some embodiments, the shaft is shaped to define a hole, and the ring is shaped to define a tab configured to fit into the hole.

[0054] In some embodiments, the apparatus further comprises:

[0055] a hollow inner longitudinal member configured to push the ring onto the shaft; and

[0056] A hollow outer longitudinal member is configured to advance the locking body over the wire as the wire passes through the inner longitudinal member and the inner longitudinal member passes through the outer longitudinal member.

[0057] In some embodiments, the outer longitudinal element is configured to retain the locking body while advancing the locking body over the thread.

[0058] In some embodiments,

[0059] The external longitudinal elements include:

[0060] External tube; and

[0061] an attachment shaped to define a hole, the attachment being coupled to and extending from the distal end of the outer tube,

[0062] The block is shaped to define a protrusion, and

[0063] By means of the protrusion passing through the hole, the outer longitudinal element is configured to retain the locking body.

[0064] In some embodiments, the attachment is tubular.

[0065] In some embodiments, the ring is configured to release the locking body from the outer longitudinal element by causing the block to be pulled toward the shaft so that the protrusion is pulled out of the hole.

[0066] In some embodiments,

[0067] The internal longitudinal elements include:

[0068] Internal tube; and

[0069] a ring push attachment shaped to define a side opening, the ring push attachment coupled to and extending beyond the distal end of the inner tube, and

[0070] The inner longitudinal element is configured to push the ring onto the shaft when the ring pushing attachment contacts the ring and the wire passes through the inner tube via the side opening.

[0071] In some embodiments, the ring pushing attachment includes a sharp edge configured to cut the wire after the ring is pushed onto the shaft.

[0072] In some embodiments, the rotation retaining element comprises a spring.

[0073] In some embodiments, the spring includes a coil wound around the rotatable element, and the coil is configured to cause the rotatable element to rotate by pushing the rotatable element, and inhibit reversal of the rotation.

[0074] In some embodiments, the at least one rotatable element comprises a pair of opposing rotatable elements, and the pair of rotatable elements are configured to clamp the wire between their respective proximal ends.

[0075] In some embodiments, the apparatus further comprises:

[0076] a hollow inner longitudinal member including a distal end configured to be inserted between corresponding proximal ends of the pair of rotatable members when the locking body is advanced into the implant and when the thread is passed through the inner longitudinal member; and

[0077] A hollow outer longitudinal element is configured to apply a reaction force to the locking body when the inner longitudinal element passes through the outer longitudinal element and the distal end of the inner longitudinal element is withdrawn from between the corresponding proximal ends of the pair of rotatable elements, so that the pair of rotatable elements rotate toward each other by the coil pushing the pair of rotatable elements together.

[0078] In some embodiments, the outer longitudinal element comprises a sharp distal edge configured to cut the wire upon rotation of the pair of rotatable elements.

[0079] In some embodiments, the respective proximal ends of the rotatable elements are shaped to define respective notches, and the distal ends of the inner longitudinal element are configured to fit into the notches.

[0080] In some embodiments, the rotatable element is shaped to define a hole, and the spring includes a wire configured to spring into the hole as the rotatable element rotates, thereby inhibiting reversal of the rotation.

[0081] In some embodiments, the apparatus further comprises:

[0082] a hollow inner longitudinal element configured to rotate the rotatable element by withdrawing from the locking body when the thread passes through the inner longitudinal element; and

[0083] A hollow outer longitudinal element is configured to apply a reaction force to the locking body when the inner longitudinal element passes through the outer longitudinal element and when the inner longitudinal element is withdrawn from the locking body.

[0084] In some embodiments,

[0085] The distal end of the inner longitudinal element is shaped to define a distal end aperture, and

[0086] The rotatable element is shaped to define a protrusion configured to fit within the distal end aperture when the locking body is advanced into the implant.

[0087] In some embodiments, the inner longitudinal member is shaped to define a side opening, and the inner longitudinal member is configured to advance the locking body to the implant when the wire is passed through the inner longitudinal member via the side opening.

[0088] In some embodiments, the inner longitudinal element includes a sharp edge that at least partially surrounds the side opening, and the sharp edge is configured to cut the wire when the inner longitudinal element is withdrawn.

[0089] According to some embodiments of the present invention, there is also provided a method for locking an implant in vivo on a thread passing through the implant. The method comprises advancing a locking body comprising at least one rotatable element onto the thread to the implant. The method further comprises, after advancing the locking body to the implant, rotating the rotatable element so that the locking body clamps the thread proximally to the implant.

[0090] According to the combined Figure 1 The present invention will be more fully understood from the following detailed description of embodiments of the present invention, which are described in the accompanying drawings: BRIEF DESCRIPTION OF THE DRAWINGS

[0092] Figure 1 is a schematic diagram of a wire deployment device deployed within the left atrium of a subject's heart according to some embodiments of the present invention;

[0093] Figure 2 is a schematic diagram of a thread deployment device in its deployed state according to some embodiments of the present invention;

[0094] Figure 3 is a schematic diagram of a longitudinal section through a tube and a tube guide according to some embodiments of the present invention;

[0095] Figure 4 is a schematic diagram of an alternative thread deployment device according to some embodiments of the present invention;

[0096] Figure 5 is a schematic diagram of a thread deployment element according to some embodiments of the present invention;

[0097] Figure 6A-6D Collectively, it is shown that according to some embodiments of the present invention, a thread is deployed into tissue by a thread deployment element;

[0098] Figure 7 is a schematic diagram of an alternative thread deployment element according to some embodiments of the present invention;

[0099] Figure 8A-8D Collectively, it is shown that according to some embodiments of the present invention, a thread is deployed into tissue by a thread deployment element;

[0100] Fig. 9 is a schematic diagram of delivering an implant to a mitral valve annulus according to some embodiments of the present invention;

[0101] Fig.10 is a schematic diagram of a tissue anchor retained within a tube according to some embodiments of the present invention;

[0102] Fig.11 is a schematic diagram of a tissue anchor in a constrained state according to some embodiments of the present invention;

[0103] Fig.12 is a schematic diagram of a tissue anchor in an expanded state according to some embodiments of the present invention;

[0104] Fig.13 is a schematic diagram of a tissue anchor for anchoring a thread-like object at a tissue of a subject according to some embodiments of the present invention;

[0105] Fig.14 is a schematic diagram of a locking member according to some embodiments of the present invention;

[0106] Figure 15A-15B According to different embodiments of the present invention, Fig.14 A schematic diagram of a longitudinal cross section of a locking member;

[0107] Fig.16A is a schematic diagram of a locking device for locking a locking member on an implant according to some embodiments of the present invention;

[0108] Fig. 16B According to some embodiments of the present invention, Fig.16A A schematic diagram of a longitudinal cross section of a portion of a locking device;

[0109] Fig.17 is a schematic diagram of a locking body advancing on a thread-like object according to some embodiments of the present invention;

[0110] Fig.18 is a schematic diagram of pushing a ring-shaped member onto a locking body according to some embodiments of the present invention;

[0111] Fig.19 is a schematic diagram of a locking member according to some embodiments of the present invention;

[0112] Fig. 20A is a schematic diagram of a locking device for locking a locking member on an implant according to some embodiments of the present invention;

[0113] Fig. 20B According to some embodiments of the present invention, Fig. 20A A schematic diagram of a longitudinal cross section of a portion of a locking device;

[0114] Fig.21 is a schematic diagram of a locking body advancing on a thread-like object according to some embodiments of the present invention;

[0115] Fig. 22 is a schematic diagram of pushing a ring-shaped member onto a locking body according to some embodiments of the present invention;

[0116] Fig.23 is a schematic diagram of a locking member according to some embodiments of the present invention;

[0117] Fig.24 is a schematic diagram of a locking device for locking a locking member on an implant according to some embodiments of the present invention;

[0118] Fig.25 is a schematic diagram of a locking member advancing on a thread-like object according to some embodiments of the present invention;

[0119] Fig.26 is a schematic diagram of locking a locking member according to some embodiments of the present invention;

[0120] Fig. 27 is a schematic diagram of a locking member according to some embodiments of the present invention;

[0121] Fig.28A is a schematic diagram of a locking device for locking a locking member on an implant according to some embodiments of the present invention;

[0122] Fig.28B It shows that according to some embodiments of the present invention, Fig.28A A longitudinal cross-section of a portion of a locking device;

[0123] Fig.29 is a schematic diagram of a locking member advancing on a thread-like object according to some embodiments of the present invention; and

[0124] Fig.30 is a schematic diagram of locking a locking member according to some embodiments of the present invention. DETAILED DESCRIPTION

[0125] Overview

[0126] Embodiments of the present invention provide devices and methods for percutaneous implantation of valvuloplasty valves and other implants.

[0127] In an embodiment of the present invention, one or more threads are deployed at an implantation site in a subject, such as a mitral valve annulus of the subject. Subsequently, an implant (such as a valvuloplasty valve) is advanced (or "delivered") over the threads to the implantation site. Next, a corresponding locking member is advanced over the threads to the implant and locked proximally to the implant. When the locking member is locked, the locking member clamps the thread, thereby locking the implant in place. After the implant is locked, the thread is cut proximally to the locking member.

[0128] In some embodiments, during the deployment of the thread, the corresponding tissue anchor connected to the thread is expanded at the tissue of the implantation site so that the anchor anchors the thread to the tissue. A specific type of anchor described herein includes a tube made of a shape memory material and one or more attachments at the proximal portion of the tube, and the tube includes a plurality of strips that couple the proximal portion of the tube to the distal portion of the tube. When the anchor is deployed, the strips are radially expanded at the distal side of the tissue to form corresponding rings, and the attachments are radially expanded within the tissue or at the proximal side of the tissue. Advantageously, the ring inhibits the anchor (and therefore the thread) from migrating proximally from the tissue while also dispersing the stress applied to the tissue, while the attachment inhibits the anchor (and therefore the thread) from migrating distally from the tissue.

[0129] In other embodiments, the thread is looped through the tissue so that a tissue anchor may not be needed.

[0130] Embodiments of the present invention also include various types of locking members. Each locking member includes at least one rotatable element and is configured to clamp the thread when the rotatable element rotates. For example, when the rotatable element rotates, the rotatable element can press the thread against another part of the locking member. Each locking member also includes a rotation retaining element that is configured to maintain the rotatable element in the position to which it is rotated, and thereby maintain the clamping of the thread. For example, the locking member may include an annular member that inhibits the rotatable element from rotating backward by fitting on the rotatable element or another part of the locking member.

[0131] Wire deployment and implant delivery

[0132] First reference Figure 1 , Figure 1 is a schematic diagram of a wire deployment device 20 deployed within a left atrium 22 of a subject's heart 24, according to some embodiments of the present invention.

[0133] To deliver the thread deployment device 20 to the left atrium 22, the sheath 26 is first percutaneously inserted into the heart 24, for example, via the femoral vein and inferior vena cava, or via the jugular vein and superior vena cava. The sheath 26 is then passed through the atrial septum and into the left atrium using techniques known in the art. The sheath 26 is typically advanced over a guidewire under fluoroscopic guidance and / or under the guidance of any other suitable imaging modality, such as ultrasound (e.g., transthoracic echocardiography (TTE) or transesophageal echocardiography (TEE)), magnetic resonance imaging (MRI), or computed tomography (CT).

[0134] After the sheath is delivered to the left atrium, the device 20 is advanced distally from the sheath 26. In some embodiments, the catheter 28 is first advanced from the sheath, and then the device 20 is pushed through the catheter 28, emerging from the distal end of the catheter.

[0135] In some embodiments, Figure 1 As shown, the sheath 26 is bent in the left atrium so that the distal opening of the sheath 26 faces the mitral valve. The catheter 28 is similarly bent. Subsequently, the device 20 is pushed toward the mitral valve from the distal opening of the catheter 28. Optionally, for embodiments in which the sheath 26 is bent in the left atrium, the catheter 28 may not be required, and the device 20 may be held by the sheath 26 and pushed from the sheath 26.

[0136] In other embodiments, the sheath 26 is not bent within the left atrium; instead, the catheter 28 is bent after being advanced from the sheath so that the opening of the catheter faces the mitral valve. The device 20 is then advanced from the catheter.

[0137] Initially, the device 20 is in a folded or "rolled" state. In some embodiments, a retaining tip 30 initially covering the distal end of the device 20 holds the device in this folded state. After the device 20 is advanced distally from the sheath 26, the retaining tip 30 is pushed away from the distal end of the device using a push wire that runs from the retaining tip through the length of the sheath 26 to the exterior of the subject. The device 20 can then be deployed (or "opened") within the atrium. In addition to removing the retaining tip 30, the slider 32 can be used to open the device, as described below with reference to Figure 2 As an alternative to using the slide 32, the covering sheath may be retracted from the device.

[0138] The device 20 includes an annular assembly (or "set") of tubes 34, and a plurality of flexible tube guides 35. Each tube 34 is slidably disposed within a corresponding tube guide 35 such that the tube guide guides the movement of the tube. Typically, each tube guide is cylindrical in shape.

[0139] The device 20 also includes an expandable annular structure 36 that is connected to the tube guide. In some embodiments, the annular structure 36 is made of a suitable shape memory material (e.g., nitinol). The push-off of the tip 30 and / or the appropriate movement of the slider 32 allows the annular structure 36 to expand, so that the annular structure 36 expands radially outward toward its predetermined "memory" shape. In other embodiments, the annular structure 36 is made of a non-shape memory material (e.g., stainless steel, polymeric tubing, and / or any other suitable metal, polymer, or combination thereof). In such an embodiment, the push-off of the tip 30 and / or the appropriate movement of the slider 32 allows the annular structure 36 to rebound from its curled state. In any case, when the annular structure is expanded, by moving the tube guide 35 radially outward, the annular structure expands the assembly of the tube on the tissue 42 of the subject.

[0140] A plurality of threads (not shown) pass from tube 34 to the exterior of the subject. As the annular structure (and thus the annular tube assembly) is deployed within the subject, the tube is positioned and / or oriented on tissue 42 for subsequent deployment of threads from the tube into tissue 42. For example, the tube may be positioned on the mitral annulus (i.e., within the left atrium, at the top surface of the annulus) for subsequent deployment of threads into the annulus.

[0141] In general, the device 20 can include any suitable number of tubes, such as 4-20 tubes. The tube 34 can be made of any suitable metal or plastic material. Typically, the tube passes through the entire length of the sheath 26 so that the proximal end of the tube 34 is located outside the subject during the entire delivery, deployment and subsequent use of the device 20. Typically, the device 20 can rotate around the central longitudinal axis 44 of the device.

[0142] Typically, the device 20 includes a plurality of longitudinal wires 38, which are typically coupled to the annular structure at the proximal end (or "top") of the annular structure. Figure 2As further described, the longitudinal wires 38 can help adjust the radius of the device 20, thereby helping to position the tubes 34 for deploying the thread-like object from the tubes, and / or helping to curl the device after the thread-like object is deployed. In some embodiments, the longitudinal wires 38 can be further used to manipulate the annular structure 36, thereby helping to position the tubes. For example, by applying a thrust to the annular structure, the longitudinal wires 38 can move the annular structure 36 (and therefore also the tubes) in an axial direction (i.e., in a direction parallel to the central longitudinal axis 44) so ​​that each tube contacts the valve annulus.

[0143] Typically, the device 20 also includes a plurality of control wires 40 coupled to respective distal portions of the tube guide 35. The control wires 40 are configured to bend the tube guide so as to position and / or orient the tube for subsequent deployment of the wire. For example, as described in reference to U.S. Pat. No. 10,463,486 to Bar et al. Fig.12 A- Fig.12 D. To move the thread-like object deployment position radially inward (ie, toward axis 44), the associated tube may be bent radially inward; conversely, to move the thread-like object deployment position radially outward, the associated tube may be bent radially outward.

[0144] After any necessary positioning and / or orientation of any particular tube 34, the tube is pushed through the tube guide containing the tube so that the tube pierces the tissue 42. The thread is then deployed from the tube, i.e., the thread is passed from within the tube or from the outer surface of the tube and through the tissue, as described below with reference to Figure 3 (The thread may be passed from the outer surface of the tube by retrieving the tube, and / or by pushing an anchor coupled to the thread from the outer surface of the tube.)

[0145] although Figure 1 The deployment of the device 20 in the left atrium is particularly shown, but it should be noted that the device 20 can be similarly deployed in other suitable locations in the subject. For example, the device 20 can be deployed in the right atrium of the subject to facilitate the delivery of the wire to the tricuspid annulus.

[0146] Reference now Figure 2 , Figure 2 is a schematic diagram of a thread deployment device 20 in an unfolded state according to some embodiments of the present invention.

[0147] First reference Figure 2 , which shows tube 34 partially passed through tube guide 35, and thread 58 passed from the distal end of the tube guide.

[0148] As above reference Figure 1As described, the tube guide 35 is flexible. For example, the tube guide 35 can be formed to define a plurality of circumferential grooves 54. For example, each groove 54 can extend at least 50%, such as at least 65%, of the circumference of the tube guide 35, so that the tube guide 35 is divided into a plurality of semi-connected segments 56 by the grooves. In such an embodiment, the tube guide 35 is flexible due to the grooves 54 because the segments 56 can rotate relative to each other. Optionally, the tube guide 35 can be flexible due to the material and / or any suitable manufacturing process of the tube guide. Typically, the tube guide 35 can be made of any suitable plastic or metal material, such as Nitinol.

[0149] As above reference Figure 1 As described above, the tube guide 35 guides the passage of the tube, thereby facilitating the deployment of the thread 58 from the tube. In some embodiments, before the deployment of the thread 58, the distal end of the thread 58 is carried in the tube 34, as described below with reference to Figure 3 Further described. In such an embodiment, thread 58 can pass through the distal end of tube guide 35 and then extend along the outside of tube guide 35 and tube 34 to the outside of the subject. Alternatively, instead of passing through the distal end of the tube guide, thread 58 can pass through a hole in the tube wall and / or a hole in the tube guide wall. As another option, thread 58 can extend from the inside of tube 34 to the outside of the subject.

[0150] In other embodiments, the distal end of the wire 58 bears on the outer surface of the tube 34 before the wire 58 is deployed. However, for ease of description, the remainder of this specification generally assumes that the distal end of the wire bears on the outer surface of the tube 34. Figure 2 In the tube 34 shown.

[0151] Typically, each tube guide is coupled to at least one control wire 40. In some embodiments, as Figure 2 As shown, each control wire 40 includes an annular distal end 46 that is coupled to a corresponding one of the tube guides. Typically, the annular distal end 46 is radially oriented so that an outer arm 48 of the annular distal end closer to the tube and tube guide is disposed at a first radius, and an inner arm 50 of the annular distal end farther from the tube and tube guide is disposed at a second radius that is less than the first radius. (In this context, "radius" refers to the distance from the axis 44.)

[0152] (It may be noted that outer arm 48 and inner arm 50 may also be said to belong to the entire control wire, not just to annular distal end 46. Thus, for example, outer arm 48 and inner arm 50 may be said to extend from annular distal end 46 to the exterior of the subject.)

[0153] In some embodiments, control wire 40 is directly coupled to the tube guide. In other embodiments, the control wire is indirectly coupled to the tube guide, for example, the control wire is coupled to annular structure 36, which in turn is coupled to the tube guide. Note that in the context of this application, including the claims, the term "coupled" may include direct or indirect coupling within its scope.

[0154] Typically, for embodiments in which the control wire is looped, each tube guide is bent by moving one proximal end of the attached control wire relative to the other proximal end of the control wire. For example, proximal end 50p of inner arm 50 may be pulled or pushed while proximal end 48p of outer arm 48 is held in place or allowed to slide freely; alternatively, proximal end 48p may be pulled or pushed while proximal end 50p is held in place or allowed to slide freely. The bending of the tube guide facilitates positioning of the tube, as described in reference to U.S. Patent 10,463,486 to Bar et al. Fig.12 A- Fig.12 D.

[0155] In other embodiments, the control wires are not circular, but rather longitudinal, similar to longitudinal wire 38. Typically, in such embodiments, each tube is coupled to two control wires, one of the two control wires being disposed at a greater radius than the other control wire. (In such embodiments, the outer control wire is similar to outer arm 48, and thus may be referred to as an "outer control arm," while the inner control wire is similar to inner arm 50, and thus may be referred to as an "inner control arm.") The two control wires may be coupled to a common point on the tube guide. Optionally, the outer control wire may be coupled at a more proximal position than the inner control wire. For example, the two control wires may be coupled to two different sections 56 of the tube, respectively, 0.5-10 mm apart from each other.

[0156] In other embodiments, a single longitudinal control wire is coupled to each of the tube guides. In such embodiments, each tube guide can be bent by moving the attached control wire relative to the tube passing through the tube guide.

[0157] As above reference Figure 1As described, the slider 32 can be used to both unfold (i.e., open) and curl (i.e., close) the assembly and annular structure 36 of the tube 34. Typically, the slider 32 slides along the "track" formed by the control wire 40; for example, the slider 32 can slide along the inner arm 50 and the outer arm 48 of the control wire. When the slider is in (or close to) its most distal position on the track, the assembly and annular structure of the tube are maintained in the curled position. Therefore, in order to curl the device, the slider 32 can slide distally along the control wire so that the slider applies a curling force on the assembly and annular structure of the tube. After the distal sliding of the slider, the catheter 28 and / or the sheath 26 can slide distally along the longitudinal wire 38, thereby further curling the device. Finally, the catheter 28 and / or the sheath 26 can pass over the device. Conversely, in order to unfold the device, the slider 32 can slide proximally along the control wire, for example, allowing the annular structure to unfold, and therefore also allowing the assembly of the tube to unfold.

[0158] Typically, each inner arm passes through the slider at a radius that is smaller than the radius of the corresponding outer arm passing through the slider. For example, the slider 32 may include a first cylinder 67a (through which the corresponding outer arm of the control line passes) and a second cylinder 67b (through which the corresponding inner arm of the control line passes), the second cylinder 67b being disposed distally of the first cylinder 67a and being configured to be narrower than the first cylinder 67a (i.e., the second cylinder 67b has a radius that is smaller than the radius of the first cylinder 67a). This configuration facilitates crimping of the device because the slider 32 can be slid to a more distal position than would otherwise be possible.

[0159] Typically, the annular structure 36 comprises a triangular wave annular member having alternating top and bottom vertices, each bottom vertex being coupled to a respective one of the tube guides. In such an embodiment, the longitudinal wire 38 is typically coupled to the top vertices of the annular structure. As described above, the longitudinal wire 38 facilitates adjustment of the radius of the device 20, as the radius can be adjusted by sliding the catheter 28 (and / or sheath 26) along the longitudinal wire. Such adjustment can assist in positioning the tube 34 so that the thread is deployed from the tube, and / or in crimping the device after the thread is deployed.

[0160] Reference now Figure 3 , Figure 3 is a schematic diagram of a longitudinal section through tube 34 and tube guide 35 according to some embodiments of the present invention.

[0161] Typically, a plurality of expandable tissue anchors 60 are disposed within the tube 34, respectively. In addition, a plurality of anchor push elements 62 are disposed within the tube, proximal to the anchors 60, respectively.

[0162] In some embodiments, Figure 3As shown, the distal end of each thread 58 is tied to a corresponding anchor 60. In such an embodiment, Figure 3 As shown, the thread 58 can pass through the distal end of the tube and the distal end of the tube guide and extend to the outside of the subject together with the tube 34; alternatively, the thread can pass through the tube. In other embodiments, the thread is coupled to the anchor by passing the thread through the anchor and tying a knot distal to the anchor (such that the diameter of the knot is greater than the diameter of the anchor). In such embodiments, typically, as Fig.10 As shown (and described below), the thread is passed through the tube, for example by means of a push element 62 that passes through the anchor.

[0163] To deploy a particular thread, the tube carrying the thread is passed through the tissue, causing the thread to also pass through the tissue. (The tube 34 may extend to the outside of the subject, in which case the tube may be pushed directly; alternatively, a separate tube pushing element disposed proximal to the tube and extending to the outside of the subject may be used to push the tube.) Subsequently, the anchor 60 is pushed from the tube using the anchor pushing element 62. Once out of the tube, the anchor 60 is deployed at the distal side of the tissue, e.g., as Fig. 9 and Fig.13 The tube and anchor push element are then retrieved into the tube guide 35 .

[0164] After the anchor 60 is deployed, tension may be continuously applied to the thread 58 to hold the anchor 60 in place until the implant is locked in place, for example, as described below with reference to Figure 14-Figure 30 Alternatively or additionally, the anchor may include one or more appendages that help hold the anchor in place by engaging tissue, for example, as described below with reference to Fig.13 described.

[0165] In some embodiments, Figure 3 As shown, each tube 34 includes a pointed distal end 64. In such embodiments, the tube 34 may alternatively be referred to as a "needle" and the tube guide 35 as a "needle guide." In some embodiments, the tube 34 is distally coupled to a needle that includes the distal end 64. In the context of the present application, including the claims, such a needle may be considered an extension of the tube.

[0166] As above reference Figure 1As described, the tube 34 can be located at the top surface of the mitral valve annulus in the left atrium. In some embodiments, to deploy the anchor 60, the tube 34 passes through the annulus and enters the left ventricle, so that the anchor 60 is deployed in the left ventricle, below the valve leaflets. In other embodiments, the tube emerges from the tissue above the valve leaflets in the left atrium. In some embodiments, the pointed distal end 64 is bent radially inwardly so that the tube exits the valve annulus through the radially-inward-facing face of the valve annulus. In such embodiments, the anchor can be deployed along the radially-inward-facing face of the valve annulus, such as Fig. 9 (Note that in the context of this application, including the claims, the term "distal" when used to refer to tissue at the implantation site may include the radially inward face of the valve annulus.)

[0167] In some embodiments, the tubes pierce tissue only after all tubes have been properly positioned and / or oriented. In other embodiments, at least one tube may pierce tissue before all tubes have been properly positioned and / or oriented, such that subsequent positioning of other tubes does not cause the first tube to move from its intended piercing position. For example, the sequence of (i) positioning and / or orienting the tubes, (ii) passing the tubes through the mitral annulus, (iii) passing the tissue anchors through the tubes, and (iv) retrieving the tubes and anchor push elements may be performed for each tube (one tube at a time). Optionally, for example, after positioning and / or orienting each tube, the tube may pierce tissue of the annulus, but the tissue anchors may not pass through the tubes until at least some of the other tubes have also pierced tissue.

[0168] It should be noted that each tube, along with a corresponding tube guide and / or any other components described above that facilitate thread deployment, may be referred to as a "thread deployment element," such that device 20 may be referred to as an annular assembly of thread deployment elements.

[0169] Reference now Figure 4 , Figure 4 is a schematic diagram of an alternative thread deployment device 20a according to some embodiments of the present invention.

[0170] Typically, device 20a is similar to device 20, for example, with respect to the manner in which the expandable annular structure 36 deploys the assembly of tube 34 on tissue prior to the deployment of the wire, and the manner in which the tube is positioned and / or oriented is similar to device 20. However, device 20a differs from device 20 in the construction of tube 34 and the manner in which the wire is deployed.

[0171] In particular, in device 20a, each tube 34 includes an arcuate distal portion 66 disposed proximal to tube guide 35. For example, distal portion 66 can be shaped to define a distally facing crescent shape, including first tube end 68a and second tube end 68b. Typically, arcuate distal portion 66 is less flexible than a more proximal portion of tube 34; for example, arcuate distal portion 66 can be rigid. (In some embodiments, a portion of tube 34 directly proximal to the arcuate distal portion can also be rigid.)

[0172] As referenced below Figure 5 and Figure 7 As further described, at least one arcuate needle is disposed within the arcuate distal portion 66. Each arcuate needle is coupled to a corresponding thread 58 ( Figure 4 34 or the like. The thread 58 may extend with the tube 34 or extend within the tube 34 to the outside of the subject as in the device 20. As further described below, the curved needle is configured to pass the thread through the tissue in an arcuate manner from the curved distal portion 66 so that the thread passes through the tissue of the valve annulus in an annular shape. With the thread passing through the tissue in an annular shape, it may not be necessary to deploy any anchors.

[0173] Typically, first tube end 68a and second tube end 68b are pointed. (Thus, as in device 20, tube 34 may be referred to as a "needle" and tube guide 35 may be referred to as a "needle guide.") In such an embodiment, to facilitate deployment of the thread, first tube end 68a and second tube end 68b may pierce the tissue of the loop before the curved needle passes from curved distal portion 66 and through the tissue.

[0174] Each tube, as well as the curved needle contained therein and / or any other components described below that facilitate thread deployment may be referred to as a "thread deployment element," such that device 20a may be referred to as an annular assembly of thread deployment elements. In this regard, reference is now made to Figure 5 , Figure 5 is a schematic diagram of a linear deployment element 65 according to some embodiments of the present invention. Figure 5 Not shown are portions of tube 34 proximal to distal portion 66, or tube guide 35.)

[0175] exist Figure 5 In the particular embodiment shown, a single curved needle 70 having a pointed distal end 70d is disposed within the curved distal portion 66. The thread 58 is coupled to the proximal end 70p of the needle 70. The thread deployment element 65 includes one or more (e.g., exactly two) distal shafts 72 coupled to the tube in contact with the needle 70. As described below with reference to Figure 6A-6DAs further described, the shaft 72 is configured to rotate to cause the needle 70 to pass through the tissue 42. Typically, the shaft 72 is rotated by rotating one or more proximal shafts 74. For example, one or more bands 76 can collectively mechanically couple the shafts 72 to each other and to the proximal shaft 74 so that the distal shaft 72 rotates in response to the rotation of the proximal shaft. (Note that any shaft that is not in contact with the needle 70 is referred to herein as a "proximal shaft," even if the shaft is fairly close to the distal portion 66 of the tube.)

[0176] Reference now Figure 6A-6D , which collectively illustrate deployment of thread 58 into tissue 42 via thread deployment element 65 according to some embodiments of the present invention.

[0177] Fig. 6A The curved distal portion 66 of the tube 34 is shown piercing the tissue 42. After piercing the tissue, as shown in FIG. Figure 6B As shown, the distal shaft 72 is rotated (by rotation of the proximal shaft 74) so ​​that the needle 70 passes through the tissue 42 in an arcuate manner from the arcuate distal portion 66. (The movement of the needle can also be described as "rotation.") As the needle passes through the tissue, the thread 58 connected to the proximal end of the needle also passes through the tissue. Typically, the needle is rotated so that the entire needle (i) passes through one of the tube ends and enters the tissue, (ii) passes through the tissue, and (iii) passes through the other tube end. For example, the needle can undergo a complete rotation of 360 degrees.

[0178] Figure 6C The configuration of the thread deployment element 65 after the needle 70 is rotated is shown. In this configuration, the thread 58 passes through the tissue in an arcuate manner from one tube end, through the other tube end, and then from the hole in the arcuate distal portion 66 to the outside of the subject. (For clarity, the thread 58 is not shown in FIG. 1 . Figure 6C , the path of the linear object 58 is emphasized. )

[0179] like Fig.6D As shown, after the needle is rotated, the tube 34 is retrieved through the tube guide so that the arcuate distal portion 66 is withdrawn from the tissue. After the thread-like object deployment element is withdrawn, the thread 58 is looped through the tissue 42 so that after the device 20a is withdrawn from the subject's body, two different sections of the thread (first section 63a and second section 63b) pass from the tissue to the outside of the subject.

[0180] Reference now Figure 7 , Figure 7 is a schematic diagram of an alternative thread-deployment element 51 according to some embodiments of the present invention. (Similar to Figure 5 , Figure 7 The entirety of the tube 34 or the tube guide 35 is not shown.)

[0181] The thread-like object deployment element 51 can be connected with the thread-like object deployment device 20a ( Figure 4 ) is used together as a substitute or supplement for the thread deployment element 65. The thread deployment element 51 is similar to the thread deployment element 65 in at least some aspects. For example, in the thread deployment element 51, the tube 34 includes an arcuate distal portion 66, which includes tube ends 68a and 68b. In addition, the thread deployment element 51 is different from the thread deployment element 65 in at least some aspects. For example, instead of a single arc needle, the thread deployment element 51 includes a pair of arc needles, and the pair of arc needles includes a first arc needle 70a and a second arc needle 70b. Typically, the first arc needle 70a includes a first pointed distal end 59a and a first needle body 61a, which are reversibly connected to each other. Similarly, the second arc needle 70b includes a second pointed distal end 59b and a second needle body 61b, which are reversibly connected to each other. The first thread 58a is connected to the first pointed distal end 59a, and the second thread 58b is connected to the second pointed distal end 59b.

[0182] As referenced below Figure 8A-8D As further described, the first curved needle 70a and the second curved needle 70b deploy the first thread 58a and the second thread 58b by passing through the tissue 42 in an arcuate manner from the first tube end 68a and the second tube end 68b toward each other. When the two curved needles collide with each other in the tissue, the distal end 59a of the first tip and the distal end 59b of the second tip are connected to each other, so that the first thread 58a is connected to the second thread 58b. Therefore, the two threads effectively become a single thread that passes through the tissue in a loop, similar to Fig.6D A loop of thread 58 is shown.

[0183] Typically, the respective proximal ends of the curved needles are coupled to hinges 55, which can be controlled by hinge control levers 53. Figure 7 As shown, the hinge 55 is v-shaped, the respective proximal ends of the curved pins are coupled to the respective ends of the hinge, and the distal end of the hinge control rod 53 is disposed inside the hinge. A spring (or "clamp") 57 applies a closing force to the hinge so that when the distal end of the hinge control rod 53 is in a relatively proximal position (e.g., Figure 7 ), the hinge is almost closed and the arcuate needle is located inside the arcuate distal portion 66. Conversely, when the hinge control lever 53 is pushed to a more distal position against the hinge, the hinge opens, causing the arcuate needle to pass from the arcuate distal portion 66 and through the tissue of the subject.

[0184] The first pointed distal end 59a and the second pointed distal end 59b can be configured to be coupled to each other in any suitable manner. Figure 7As shown, the distal end 59a of the first tip can be shaped to define a convex connection tip, and the distal end 59b of the second tip can be shaped to define a concave connection tip, which is configured to cooperatively receive the distal end 59a of the first tip. When sufficient force is applied to the hinge 55 by the hinge control rod 53, the distal end 59a of the first tip is forced into the distal end 59b of the second tip.

[0185] Reference now Figure 8A-8D , which collectively illustrate the deployment of threads 58a and 58b into tissue 42 by thread deployment element 51 according to some embodiments of the present invention.

[0186] First, if Fig. 8A As shown, the first tube end 68a and the second tube end 68b pierce the tissue 42. Next, as Figure 8B As shown by the downward arrow in , the hinge control lever pushes the hinge, causing the hinge to open and the curved needle to pass through the tissue. When the hinge is fully opened, the distal end 59a of the first tip is connected to the distal end 59b of the second tip. Then, as shown in FIG. Figure 8C As shown by the upward arrow in , the hinge control rod is withdrawn (i.e., moved proximally), so that the hinge 55 is closed by the spring 57. When the hinge is closed, the force applied by the hinge to the first needle body 61a and the second needle body 61b exceeds the connection force between the needle body and the corresponding distal end of the needle. Therefore, the needle body of the needle is separated from the corresponding distal end. Finally, as shown in FIG. Fig.8D As shown, the withdrawal thread deployment element 51 is withdrawn.

[0187] Reference now Fig. 9 , which is a schematic diagram of delivering an implant 71 to a mitral valve annulus 75 according to some embodiments of the present invention.

[0188] After the wire 58 is deployed, the wire deployment device is crimped and inserted into the catheter 28 and / or sheath 26 ( Figure 1 ), and then withdrawn from the subject. Subsequently, the implant 71 can be delivered to the mitral valve annulus 75 on the thread. Fig. 9 As shown, implant 71 may comprise an annuloplasty ring. Alternatively, for example, the implant may comprise a replacement valve.

[0189] First, the implant 71 is loaded onto the wire by passing the proximal end of the wire through the corresponding hole in the implant. (Note that the implant can be loaded onto the wire even before the wire is deployed.) As described above for device 20a ( Figure 4 ) as described above, a single thread that passes through tissue in a loop can be used as two separate threads because each segment (or "arm") of the loop can be passed through a different corresponding hole in the implant.

[0190] Next, a plurality of hollow push rods 73 including respective distal heads 79 can be loaded to the thread proximally at the implant. The push rods 73 can then push the implant along the thread through the sheath 26 to the valve annulus. Note that the push rods 73 are typically flexible so that the push rods can follow any number of turns within the subject. Similarly, various other rods, tubes, and other instruments for advancing various elements (e.g., locks) along the thread are typically flexible, as described herein.

[0191] In some embodiments, one or more retrieval wires 69 surround the implant 71. If the physician determines that the implant is incorrectly positioned (i.e., the wire is incorrectly placed), decides to replace the implant 71 with another implant (e.g., because the implant 71 is not the correct size or shape), or decides not to perform any implantation at all, the retrieval wire 69 can be used to retrieve the implant 71. Subsequently, even if the implantation is not performed, it may not be necessary to perform an invasive procedure on the subject; instead, assuming that the anchor 60 is fixed, simply cutting the wire 58 may be sufficient.

[0192] Note that each thread may include a polymer, a metal (eg, Nitinol), and / or any other suitable material. For embodiments where the thread is metal, the thread may also be referred to as a "wire."

[0193] Anchor

[0194] Reference now Fig.10 , Fig.10 is a schematic diagram of a tissue anchor 60 retained within a tube 34 according to some embodiments of the present invention. Fig.11 and Fig.12 , Fig.11 is a schematic diagram of an anchor 60 in a constrained state according to some embodiments of the present invention, Fig.12 is a schematic diagram of an anchor 60 in an expanded state according to some embodiments of the present invention. Fig.12 Both an isometric view of the anchor and a view from the distal end of the anchor are shown.)

[0195] In some embodiments, the anchor 60 includes a proximal portion 60p, a distal portion 60d, and a plurality (e.g., between two and eight) of strips 84 that join the proximal portion 60p to the distal portion 60d. Typically, the proximal portion 60p is shaped to define one or more (e.g., two) appendages (or "arms") 82 that are joined to the remainder of the proximal portion 60p at their proximal ends. The appendages 82 may include, for example, corresponding tines 83 or loops.

[0196] Typically, the anchor is at least partially hollow and the thread passes at least partially through the anchor. In order to connect the anchor to the thread (i.e., to inhibit the thread from sliding from the anchor), the thread can be knotted on the distal side of the anchor. Optionally, the thread (e.g., the distal end of the thread) can be attached to the inner wall of the distal portion of the anchor, for example by applying an adhesive or by welding. (To facilitate such attachment, the distal portion 60d can be shaped to define a side opening 77.) Alternatively, the thread can be knotted on the distal side of the proximal portion of the anchor, or attached to the inner wall of the proximal portion of the anchor. (Typically, polymer threads are knotted, while metal threads are attached to the inner wall of the anchor.)

[0197] In some embodiments, the anchor push element 62 comprises a hollow shaft, and the wire 58 extends through the shaft. In other embodiments, the anchor push element comprises a solid shaft, and the wire extends through the tube along with the shaft.

[0198] When held within the tube 34, the anchor 60 is in a restrained state by virtue of the radial restraining force applied to the anchor by the tube, such as Figure 10-11 Typically, when the anchor is constrained, the diameter D0 of the anchor is between 0.3 mm and 2 mm. Alternatively or additionally, the length L0 of the anchor may be between 5 mm and 50 mm.

[0199] Typically, the proximal portion of the anchor is shaped to define the appendage 82 by virtue of the fact that a corresponding recess 88 is defined beneath the appendage as a result of the shaping; in other words, the appendage 82 is typically cut from the proximal portion of the anchor. Thus, advantageously, the appendage may not extend radially beyond any other portion of the anchor when constrained.

[0200] When the tube 34 reaches the location where the thread 58 is to be deployed, the tube is passed through the tissue and then the anchor 60 is pushed from the tube using the anchor pushing element 62. When the radial restraining force applied by the tube is removed, the anchor expands radially, using Fig.12 84 is radially expanded to form respective rings, which are typically arranged in a circular form. In addition, the appendages 82 are radially expanded. Typically, as the appendages 82 are expanded, the angle θ between each appendage and the longitudinal axis 90 of the proximal portion of the anchor is between 5 degrees and 60 degrees.

[0201] Typically, even when the anchor is constrained, the strips are not parallel to the longitudinal axis 90. Instead, there is a circumferential angular displacement between the proximal end of each strip (which is connected to the proximal portion 60p) and the distal end of the strip (which is connected to the distal portion 60d). Fig.12As shown in the particular strip 84a identified in FIG. 1 , the circumferential angle α between the proximal and distal ends of the strip can be at least 5 degrees, such as 5 degrees to 200 degrees, such as 10 degrees to 30 degrees. Advantageously, due to this angular displacement, the plane 85 defined by each strip after the strip is deployed is at least partially perpendicular to the longitudinal axis 90 and is therefore at least partially parallel to the surface 92 of the tissue ( Fig.13 ). Thus, the strips can spread the stress applied to the tissue over a larger area.

[0202] Typically, anchor 60 is made of a shape memory material, such as Nitinol. Strip 84 is formed by cutting slits 86, such as spiral slits, in the middle portion of the tube, and appendage 82 is formed by cutting grooves 88 in the proximal portion of the tube. (Slits 86 and grooves 88 may be laser cut, or may be formed using any other suitable technique.) After cutting slits 86 and grooves 88, the anchor is heat set into its deployed shape.

[0203] Reference now Fig.13 , Fig.13 is a schematic diagram of an anchor 60 anchoring a thread 58 at a tissue 42 according to some embodiments of the present invention.

[0204] To anchor the thread 58, the tube 34 ( Fig.10 ) through tissue 42. Subsequently, anchor 60 is partially pushed from the tube, causing strip 84 to expand radially at the distal side (or "distal side") of tissue 42, i.e., at the side of the tissue opposite the proximal side (or "proximal side") where implant 71 will be implanted. Due to the expansion of the strip (which, in its expanded state, may alternatively be referred to as a "loop"), proximal migration of anchors and threads from the tissue is inhibited.

[0205] Next, the thread is pulled, causing the strip 84 to be pulled toward the distal surface 92 of the tissue. As the thread is pulled, the tube is withdrawn from the proximal portion of the anchor, causing the appendage 82 to also deploy. Depending on the distance between the appendage and the strip relative to the thickness of the tissue, the appendage can be deployed within the tissue (e.g., Fig.13 ) or deployed proximally of the tissue, for example, so that the distal end of the appendage contacts the proximal surface 94 of the tissue. In either case, as the deployed appendage engages the tissue, migration of the anchor and thread from the tissue distally is inhibited.

[0206] Typically, after the strip is deployed, the diameter D1 of the strip (which may also be referred to as the maximum diameter of the anchor) is between 4 mm and 30 mm. Alternatively or additionally, the length L1 of the anchor (which is less than the length L0 (due to the radial deployment of the strip)) is between 4 mm and 30 mm. Fig.11 )) can be between 4mm and 30mm.

[0207] After all anchors are deployed, the tube is withdrawn from the subject. Fig. 9 As described above, the implant 71 is delivered on the thread. Next, the push rod 73 ( Fig. 9 ) after which the corresponding locking member 80 (at Fig.13 Schematically shown in , without structural details) is advanced to the implant on the thread. As described in detail below with reference to the subsequent drawings (which show various embodiments of the locking member 80), the locking member clamps the thread to the proximal side of the implant, thereby locking the implant on the thread.

[0208] Locking parts

[0209] Each of the various locking members described below includes a locking body configured to be advanced to an implant over a thread, the locking body including at least one rotatable element. The locking body is configured to clamp the thread proximally at the implant when the rotatable element rotates. Each locking member also includes a rotation retaining element configured to inhibit the reversal of the rotation of the rotatable element by engaging with the locking body, that is, configured to retain the rotatable element in the position to which it is rotated, and thus maintain the clamping of the thread.

[0210] For further details, first refer to Fig.14 , Fig.14 is a schematic diagram of a locking member 80a according to some embodiments of the present invention. Figure 15A-15B , which are schematic longitudinal cross-sectional views through a locking member 80a according to different corresponding embodiments of the present invention.

[0211] The locking member 80a includes a locking body 96, which includes a pin 100 and a rotatable element 102, which is optionally referred to as a "wire" or "rod", and the rotatable element 102 is rotatably coupled to the pin 100 by the pin passing through the rotatable element 102. (The rotatable element 102, as well as each of the other rotatable elements described herein, can have any suitable shape.) Typically, the locking body also includes two support blocks 106, one on each side of the element 102, which support the pin; in other words, typically, the pin passes through the element 102 from one support block 106 to the other support block. The rotatable element 102 is configured to lock the implant on the wire 58 by rotating toward another portion of the locking body 96 so that the rotatable element presses the wire against the other portion of the locking body.

[0212] For example, the locking body may include a non-rotating block 104, and when the rotatable element is rotated toward the block, the rotatable element may press the thread against the block 104. (Block 104, and each of the other blocks described herein, may have any suitable shape.) Alternatively, instead of block 104, the locking body may include another opposing rotatable element, and the pair of opposing rotatable elements may be configured to rotate toward each other, thereby clamping the thread between them.

[0213] The locking member 80a further includes an annular member 98, which is configured to cause the rotatable element to rotate by fitting on the rotatable element and inhibit the reversal of the rotation. Fig.14 As shown, the ring can be fitted on the rotatable element by fitting over the entire locking body.) In some embodiments, the block 104 is shaped to define one or more recesses 108, and the ring 98 is shaped to define corresponding tabs 110 that are configured to fit into the recesses 108. Advantageously, the fitting of the tabs 110 into the recesses inhibits the ring from sliding off the locking body.

[0214] In some embodiments, Fig.15A As shown, the rotatable element and / or the block 104 includes a serrated surface 116, and the locking body is configured to clamp the wire with the serrated surface 116. Alternatively or additionally, as Fig. 15B As shown, the block 104 may be shaped to define a recess 114, the rotatable element 102 may be shaped to define a complementary protrusion 112 configured to fit into the recess 114 when the rotatable element is rotated, and the locking body may be configured to clamp the wire between the protrusion 112 and the recess 114. Advantageously, the serrated surface and / or the curvature of the portion of the wire pressed into the recess by the protrusion increases the friction generated by any sliding of the wire through the locking body, thereby inhibiting any such sliding.

[0215] Reference now Fig.16A , which is a schematic diagram of a locking device 118a for locking a locking member 80a on an implant according to some embodiments of the present invention. Fig. 16B , Fig. 16B is a schematic illustration of a longitudinal section through a portion of instrument 118a, according to some embodiments of the present invention.

[0216] The instrument 118a includes an outer longitudinal element 120 configured to lock the locking member 80a by pushing the ring 98 onto the rotatable element 102. Typically, the outer longitudinal element 120 includes a distal tube 120d or any other appropriately shaped structure having an inner diameter and / or outer diameter that is the same as the inner diameter and / or outer diameter of the ring, so that the distal surface of the tube 120d can contact the proximal surface of the ring. Typically, the outer longitudinal element also includes a narrower, more proximal tube 120p that is coupled to the distal tube 120d.

[0217] Typically, instrument 118a also includes an inner longitudinal element 122 configured to advance locking body 96 over the wire as the wire is passed through the inner longitudinal element 122 and the inner longitudinal element passes through the outer longitudinal element.

[0218] For further details, refer now also to Fig.17 and Fig.18 , Fig.17 is a schematic diagram of a locking body advancing on a thread-like object according to some embodiments of the present invention, Fig.18 is a schematic diagram of pushing a ring onto a locking body according to some embodiments of the present invention.

[0219] Typically, the ring and the locking body are advanced together on the thread. For example, the ring can be partially loaded onto the locking body 96 so that the ring covers the proximal portion of the locking body, and the pin 100 is arranged at the proximal portion without the distal portion of the rotatable element pushing the thread. Subsequently, the external longitudinal element and the internal longitudinal element can be advanced on the thread, and the thread passes between the rotatable element 102 and the block 104, so that both the ring and the locking body are advanced to the implant from the outside of the subject. (With the ring partially loaded on the locking body, the external longitudinal element can advance the locking body by pushing the ring, and / or the internal longitudinal element can advance the ring by pushing the locking body.) Subsequently, in response to the locking member contacting the implant, the external longitudinal element can be used to push the ring further onto the locking body, while the implant provides a reaction force to the locking body, thereby forcing the rotatable element to rotate.

[0220] In some embodiments, the inner longitudinal element 122 is shaped to define a hole 124 (or notch), and one of the tabs 110 is configured to fit into the hole 124 when the locking body is advanced on the wire. Advantageously, the hole 124 facilitates advancement of the ring and the locking body together by inhibiting the ring from sliding off the locking body.

[0221] For example, the ring can be loaded onto the locking body such that the proximal tab 110p of the ring fits into the hole 124 and the distal tab 110d of the ring fits into one of the notches 108, such as the most proximal notch 108. Subsequently, a pushing force applied to the ring by the external longitudinal element can force the proximal tab 110p out of the hole 124 and then push the ring onto the locking body until the proximal tab 110p snaps into one of the notches 108, such as the most proximal notch 108.

[0222] Typically, in such embodiments, the inner longitudinal element includes a distal tube 122d or any other appropriately shaped structure having an outer diameter that is the same as the inner diameter of the ring 98 and shaped to define a hole 124 into which the tab 110p can fit. Typically, the inner longitudinal element also includes a narrower proximal tube 122p that is joined to the distal tube 122d.

[0223] Typically, the inner longitudinal element 122 includes a sharp distal edge 126 that is configured to cut the thread 58 after the ring is pushed onto the rotatable element 102. For example, after locking the lock, the instrument 118a can be slightly withdrawn from the lock. Subsequently, the inner longitudinal element can be pushed out of the outer longitudinal element so that the edge 126 cuts the thread. Subsequently, the instrument 118a and the proximal portion of the thread 58 can be removed from the subject.

[0224] Reference now Fig.19 , Fig.19 is a schematic diagram of another locking member 80b according to some embodiments of the present invention.

[0225] Locking member 80b is similar to locking member 80a in several respects ( Fig.14 ). For example, the locking member 80b also includes a locking body 96, which includes at least one rotatable element. As a specific example, the locking member 80b may include a block 103, a first rotatable element 102a disposed at one side of the block 103, and a second rotatable element 102b disposed at the opposite side of the block, and a pin 100 passing through the block and the two rotatable elements. In addition, similar to the locking member 80a, the locking member 80b includes a ring 98, which is configured to rotate the rotatable element (one or more) by fitting on the locking body.

[0226] However, the lock 80b is also different from the lock 80a. For example, in the lock 80b, the lock body includes a shaft 130 disposed beside at least one rotatable element (e.g., between the first rotatable element 102a and the second rotatable element 102b, opposite the block 103), and the ring 98 is configured to cause the rotatable element to rotate by fitting on the shaft 130 so that the ring pushes the rotatable element (one or more). In addition, the lock body includes another pin 128. Further details about these features and other features of the lock 80b will be described below with reference to subsequent figures.

[0227] Reference now Fig. 20A , which is a schematic diagram of a locking device 118b for locking a locking member 80b on an implant according to some embodiments of the present invention. Fig. 20B , Fig. 20B is a schematic diagram of a longitudinal section through a portion of the instrument 118b according to some embodiments of the present invention. (For clarity, the rotatable element 102a is shown in FIG. Fig. 20B is drawn transparently in . )

[0228] The instrument 118b includes a hollow inner longitudinal element 132 configured to push a ring onto the shaft 130. For example, the inner longitudinal element 132 may include an inner tube 138 and a ring pushing attachment 140 shaped to define a side opening 142, the ring pushing attachment 140 being coupled to and extending beyond the distal end of the inner tube 138. In such an embodiment, the inner longitudinal element may push the ring onto the shaft while the ring pushing attachment 140 contacts the ring and the thread passes through the inner tube via the side opening 142. (In some embodiments, the ring pushing attachment includes a ring having a plurality of distally projecting legs 144, with the side opening 142 disposed between the legs 144.) Alternatively, the inner tube 138 itself may be shaped to define the side opening 142, such that the inner tube may push the ring onto the shaft while the inner tube contacts the ring and the thread passes through the side opening.

[0229] The instrument 118b also includes a hollow outer longitudinal element 134 configured to push the locking body on the thread 58 when the thread passes through the inner longitudinal element (as described above) and the inner longitudinal element passes through the outer longitudinal element 134. For example, the outer longitudinal element 134 may include an outer tube 136 that contacts the locking body, so that the outer tube 136 directly pushes the locking body. Optionally, in addition to the outer tube 136, the outer longitudinal element may include an attachment 146 (e.g., including another tube that is wider than the outer tube 136), which is coupled to the distal end of the outer tube and extends from the distal end of the outer tube, so that the outer longitudinal element pushes the locking body by contacting the locking body through the attachment 146.

[0230] Typically, the outer longitudinal element 134 is configured to hold the locking body while advancing the locking body on the thread. For example, the attachment 146 (or the outer tube itself) can be shaped to define a hole 148, the block 103 can be shaped to define a protrusion 150, and the outer longitudinal element can hold the locking body by passing the protrusion 150 through the hole 148.

[0231] Reference now Fig.21 and Fig. 22 , Fig.21 is a schematic diagram of a locking body advancing on a thread-like object according to some embodiments of the present invention, Fig. 22 is a schematic diagram of pushing the ring member onto the locking body according to some embodiments of the present invention. Figure 21-22 A longitudinal section through the instrument 118b and the locking body 96 is shown, wherein the rotatable element 102a is not shown.)

[0232] The shaft 130 is shaped to define an inclined groove 152 that is inclined away from the block 103 at least along its proximal portion 156. The pin 128 coupled to the rotatable elements 102a and 102b passes through the groove 152. Fig.19 As described, the pin 100 defining the axis of rotation of the rotatable element passes through the block 103 and the two rotatable elements. Typically, the shaft 130 is shaped to define a hole 154 (or recess), and the tab 110 is configured to fit into the hole 154. In some embodiments, the shaft 130 and / or the block 103 include a serrated surface 116; alternatively or additionally, the shaft and the block may be shaped to define complementary protrusions and recesses.

[0233] Typically, the locking body and the ring 98 are advanced together over the wire 58. First, the ring 98 is partially loaded onto the shaft 130 so that the tabs 110 are proximal to the holes 154. Subsequently, the inner longitudinal element 132 and the outer longitudinal element 134 push the locking member over the wire 58, which is passed between the block 103 and the shaft 130 until the locking member contacts the implant 71. (With the ring partially loaded onto the shaft, the outer longitudinal element can push the ring, and / or the inner longitudinal element can push the locking body by pushing the ring.) When the locking member is advanced to the implant, the rotatable elements are in their rest (unrotated) position so that the pin 128 is disposed at or near the proximal end of the groove 152.

[0234] In response to the locking member contacting the implant, the inner longitudinal element 132 is used to push the ring 98 further onto the shaft, while the implant provides a reaction force to push. When performing this pushing, the ring pushes the rotatable element, causing the rotatable element to rotate. Since the movement of the pin 128 is constrained by the groove 152 (and since the distance between the two pins is fixed), by rotating the rotatable element, the ring causes the block 103 to be pulled toward the shaft, causing the locking body to clamp the linear object between the block and the shaft. In addition, by pulling on the block, the rotatable element can pull the protrusion 150 from the hole 148, causing the locking body to be released from the outer longitudinal element.

[0235] When the tab 110 snaps into the hole 154, the ring is locked on the shaft, thereby maintaining the rotated position of the rotatable element and thus maintaining the clamping of the wire. To further facilitate the locking of the locking member, the distal portion 158 of the groove can be inclined toward the block so that the pin 128 is inhibited from moving proximally through the groove.

[0236] After locking the lock, the outer longitudinal element and the inner longitudinal element are withdrawn. Typically, the inner tube 138 or the ring-like member pushing attachment 140 includes a sharp edge 160, which is configured to cut the wire after the ring-like member is pushed onto the shaft. Thus, the wire can be cut by pushing the inner tube while the wire is tightened.

[0237] It should be noted that Figure 21-22 The above description also applies to the locking body comprising a single rotatable element (by Figure 21-22 The rotatable element 102b in the figure represents an embodiment of a device having two rotatable elements.

[0238] Reference now Fig.23 , Fig.23 is a schematic diagram of another locking member 80c according to some embodiments of the present invention.

[0239] Similar to locks 80a and 80b, lock 80c includes a lock body 96 that includes at least one rotatable element. In addition, as in locks 80a and 80b, the lock body is configured to clamp wire 58 at the proximal side of the implant when the rotatable element is rotated.

[0240] For example, the locking body may include a pair of opposing rotatable elements configured to clamp a thread between respective proximal ends of the rotatable elements when the rotatable elements are rotated. The pair of rotatable elements may include a first rotatable element 102a configured to rotate relative to a first pin 100a, and a second rotatable element 102b configured to rotate relative to a second pin 100b. One or both rotatable elements may include a serrated surface 116 such that the rotatable elements are configured to clamp a thread with the serrated surface; alternatively or additionally, the pair of rotatable elements may be shaped to define complementary protrusions and recesses.

[0241] However, the locking member 80c is different from the locking members 80a and 80b, at least in that in the locking member 80c, the rotation holding element includes a spring 162, and the spring 162 includes a coil 164 wound around the rotatable element. The coil 164 is configured to cause the rotatable element to rotate by pushing the rotatable element together and inhibit any reversal of rotation. In some embodiments, in order to inhibit the coil from slipping off the rotatable element, at least one rotatable element is shaped to define a ridged surface 166, and the coil 164 passes between the ridges of the ridged surface. Further details about the locking of the locking member 80c will be described below with reference to subsequent drawings.

[0242] Reference now Fig.24 , which is a schematic diagram of a locking instrument 118c for locking a locking member 80c on an implant according to some embodiments of the present invention. (For clarity, a portion of the instrument 118c is shown in cross-section.) Further reference is made to Fig.25 and Fig.26 , Fig.25 is a schematic diagram of a locking member advancing on a linear object according to some embodiments of the present invention, Fig.26 is a schematic diagram of locking a locking member according to some embodiments of the present invention.

[0243] The instrument 118c includes a hollow outer longitudinal element 168 and a hollow inner longitudinal element 174, wherein the hollow outer longitudinal element 168 may include a narrower proximal outer tube 170 coupled to a wider distal outer tube 172. The inner longitudinal element 174 includes a distal end 180, which is configured to be inserted between the corresponding proximal ends of the rotatable elements when the locking body is advanced into the implant. Due to this insertion, the thread can pass between the rotatable elements (and through the inner longitudinal element) without being clamped by the locking body. In some embodiments, to facilitate this insertion, the corresponding proximal ends of the rotatable elements are shaped to define corresponding recesses 182, and the distal end 180 is configured to fit into the recesses 182.

[0244] In some embodiments, inner longitudinal element 174 includes inner tube 176 and attachment 178, such as a tubular attachment, coupled to and extending from a distal end of tube 176, attachment 178 including distal end 180. Alternatively, inner tube 176 itself may include distal end 180.

[0245] In order to advance the locking body to the implant, the inner longitudinal element and / or the outer longitudinal element can be used to push the locking body, while the thread 58 passes through the inner longitudinal element and the inner longitudinal element passes through the outer longitudinal element. During the locking body advancement process, the coil is extended outwardly by the rotatable element by the insertion of the distal end 180.

[0246] like Fig.26 As shown, as the locking body is advanced, in response to the locking body contacting the implant, the distal end of the inner longitudinal element is withdrawn from between the pair of rotatable elements, while the outer longitudinal element applies a reaction force to the locking body. The withdrawal of the inner longitudinal element causes the coil to rebound inward from its extended state, thereby pushing the pair of rotatable elements toward each other, causing the pair of rotatable elements to rotate toward each other and thus clamping the thread-like object therebetween.

[0247] After locking of the lock, the instrument 118c is withdrawn. In some embodiments, the outer longitudinal element comprises a sharp distal edge 184 configured to cut the wire after rotation of the rotatable element.

[0248] In some embodiments, the locking body comprises a single rotatable element and an opposing (non-rotatable) block. In such embodiments, the coil is wound around the rotatable element and the block so that the coil causes the wire to be clamped between the rotatable element and the block. The rotatable element and / or the block may comprise a serrated surface; alternatively or additionally, these elements may be shaped to define complementary protrusions and recesses.

[0249] Reference now Fig. 27 , Fig. 27is a schematic diagram of another locking member 80d according to some embodiments of the present invention.

[0250] Similar to lock 80c, lock 80d includes a spring 162 configured to maintain the rotated position of rotatable element 102. However, in lock 80d, the rotatable element is shaped to define a hole 186, and spring 162 includes a wire 188 configured to spring into hole 186 as the rotatable element rotates, thereby inhibiting any reversal of the rotation.

[0251] For example, in the locking member 80d, the locking body 96 may include a first panel 190a, a second panel 190b, and a block 192 disposed between the first panel 190a and the second panel 190b. Figure 29-Figure 30 As shown, the wire 188 can extend along the second panel 190b, through the second panel 190b, through the rotatable element 102, through the first panel 190a, and finally through the groove 194 (or hole) in the first panel 190a so that the end of the wire reaches the rotatable element. When the rotatable element rotates relative to the wire 188 (i.e., relative to the rotation axis defined by the wire), the rotatable element presses the wire against the block 192, and the wire 188 springs into the hole 186.

[0252] For further details, refer now to Fig.28A and Fig.28B , Fig.28A is a schematic diagram of a locking device 118d for locking a locking member on an implant according to some embodiments of the present invention, Fig.28B A longitudinal cross section through a portion of the instrument 118d is shown according to some embodiments of the present invention. Fig.28B In the embodiment, the first panel 190a is not shown, so that the rotatable element 102 is exposed. ) Also refer to Fig.29 and Fig.30 , Fig.29 is a schematic diagram of a locking member advancing on a thread 58 according to some embodiments of the present invention, Fig.30 Schematic diagram of locking of a locking member according to some embodiments of the present invention. Figure 29-Figure 30 The right portion of each of the figures shows the locking body as viewed from the side of the left portion of the figure, with the block 192 hidden to expose the rotatable element 102.)

[0253] The instrument 118d includes an outer longitudinal element 196, which includes, for example, an outer tube. The instrument 118d also includes an inner longitudinal element 198, which includes, for example, an inner tube. In order to advance the locking body to the implant, the outer longitudinal element 196 and / or the inner longitudinal element 198 can be used to push the locking body while the thread 58 passes through the inner longitudinal element and the inner longitudinal element passes through the outer longitudinal element.

[0254] Typically, the distal end of the inner longitudinal element is shaped to define a hole 202 (or recess), and the rotatable element 102 is shaped to define a protrusion 204 that is configured to fit within the hole 202. Fig.29 As shown, when the locking body is advanced into the implant, the protrusion 204 is within the hole 202, and the wire 58 extends between the rotatable element and the block 192 without being clamped by the locking body. In addition, during the advancement of the locking body, the wire 188 is deformed from its resting state because the end 208 of the wire 188 is pushed away from the locking body by the rotatable element 102.

[0255] like Fig.30 As shown, in response to the locking body contacting the implant, the inner longitudinal element 198 is withdrawn from the locking body while the outer longitudinal element 196 applies a reaction force to the locking body. The withdrawal of the inner longitudinal element dislodges the protrusion 204 from the hole 202 and rotates the rotatable element so that the surface 206 of the rotatable element presses the wire against the block 192. (The surface 206 can be serrated, and / or the surface 206 and the block 192 can be shaped to define complementary protrusions and depressions.) The rotation of the rotatable element also aligns the hole 186 with the end 208 of the wire, causing the wire to spring into the hole, thereby locking the rotatable element in the position it is rotated to.

[0256] Typically, the inner longitudinal element 198 is shaped to define a side opening 200, and the inner longitudinal element is configured to advance the locking body to the implant when the thread passes through the inner longitudinal element via the side opening. Typically, the outer longitudinal element is also shaped to define a side opening 210, so that the thread passes through the locking body, through the side opening 210, through the side opening 200 and through the inner longitudinal element. In some embodiments, the inner longitudinal element includes a sharp edge, which at least partially surrounds the side opening 200, and the sharp edge 212 is configured to cut the thread when the inner longitudinal element is withdrawn.

[0257] In some embodiments, for situations where multiple locking members are required for an implant, the locking members are delivered to the implant and locked sequentially, for example, using the same locking instrument to deliver and lock each locking member. In other embodiments, different corresponding locking instruments are used to deliver and lock the locking members simultaneously. For example, different corresponding locking instruments 118a can be used to deliver and lock multiple locking members 80a. In such embodiments, a locking instrument can also be used instead of the push rod 73 ( Fig. 9 That is, the implant can be loaded onto the thread, the locking member can be loaded onto the thread proximal to the implant, and then the locking instrument can advance the implant and the locking member together to the implantation site.

[0258] Those skilled in the art will recognize that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of protection of the present invention includes combinations and sub-combinations of the various features described hereinabove, as well as changes and modifications of the present invention that are not in the prior art that would occur to those skilled in the art upon reading the foregoing description.

Claims

1. A device for percutaneous implantation of an implant, include: a tube configured to pass through tissue of a subject from a proximal side of the tissue to a distal side of the tissue; a thread configured to pass through the tube; and a tissue anchor coupled to the thread and configured to be pushed through the tube to the distal side of the tissue, the tissue anchor comprising: a proximal portion shaped to define one or more appendages; a distal portion; and a plurality of straps coupling the proximal portion to the distal portion, wherein the straps and the appendages are radially constrained within the tube when the tissue anchor is within the tube; wherein, during the process of the tissue anchor being pushed through the tube to the distal side of the tissue, the strip first passes through the tube to the distal side of the tissue and the appendage remains in the tissue; and wherein after the tissue anchor has been pushed through the tube, the strips are radially expanded to form corresponding loops at the distal side of the tissue, and the appendages are radially expanded within the tissue, thereby anchoring the thread at the tissue.

2. The device according to claim 1, in, The strips are configured to expand so that the loops are arranged in a circular formation.

3. The device according to claim 1, in, The attachment comprises corresponding tines.

4. The device according to claim 1, in, The thread at least partially passes through the anchor.

5. The device according to claim 4, in, The anchor is coupled to the thread by means of the thread being knotted distally of the anchor.

6. The device according to claim 4, in, The anchor is coupled to the thread by means of the thread being attached to the inner wall of the distal portion of the anchor.

7. The device according to claim 1, in, The strips include 2-8 strips.

8. The device according to any one of claims 1 to 7, in, For each of the straps, a circumferential angle between a proximal end of the strap and a distal end of the strap is at least 5 degrees.

9. The device according to claim 8, in, The circumferential angle is between 10 degrees and 30 degrees.

10. The device according to any one of claims 1 to 7, in, The proximal portion of the anchor is shaped to define the appendage by virtue of being shaped to define a corresponding recess beneath the appendage.

11. The device according to claim 10, in, Prior to removal of the restraining force, the appendage does not extend radially beyond any other portion of the anchor.

12. The device according to any one of claims 1 to 7, in, As the appendages are deployed, each of the appendages has an angle between 5 and 60 degrees with the longitudinal axis of the proximal portion of the anchor.

Images