Annuloplasty and tissue anchor technologies

Abstract

To provide a novel apparatus for use with an anchor driver.SOLUTION: A system and / or an apparatus includes a wire (212), and first and second anchors (620). Each of the first and second anchors may be configured to include (i) a tissue-engaging element (230) having a sharpened distal tip and configured to be driven into tissue of a subject and (ii) a head (680) coupled to a proximal end of the tissue-engaging element. The head can include: a driver interface (282) configured to be reversibly engaged by an anchor driver (260); and an opening such as an eyelet (640) defining an aperture (646) through which the wire is threaded. Other applications are also described.SELECTED DRAWING: Figure 4B

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application is U.S. Provisional Patent Application No. 62 / 927,624, filed October 29, 2019, by Kasher et al., entitled "Annuloplasty and Tissue Anchor Technologies," and U.S. Provisional Patent Application No. 62 / 949,392, filed December 17, 2019, by Kasher et al., entitled "Annuloplasty and Tissue Anchor Technologies"; Claim priority of.

[0002] The above-referenced applications are incorporated herein by reference for all purposes. [Background technology]

[0003] Annuloplasty involves remodeling tissue at the annulus. This can be done by pulling the tissue around the annulus into a new shape. Tissue anchors can be used to enable medical procedures, including annuloplasty, other tissue remodeling, and securing implants. In some cases, tissue anchors can be used as an alternative to sutures. For example, tissue anchors can be used for procedures where there is no line of sight to the subject. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] US Patent Application Publication No. 2015 / 0272734 [Patent Document 2] US Patent Application Publication No. 2018 / 0049875 [Patent Document 3] International Publication No. 2020 / 012481 Brochure Summary of the Invention [Means for solving the problem]

[0005] This Summary provides some examples and is not intended to limit the scope of the invention in any way. For example, any feature included in the examples of this Summary is not required by a claim unless the claim explicitly recites the feature. Also, features, components, steps, concepts, etc. described in this Summary and in examples elsewhere in this disclosure may be combined in various ways. Various features and steps described elsewhere in this disclosure may be included in the examples summarized here.

[0006] Some applications relate to tissue anchors that are configured (e.g., shaped) to be slidable along a wire, line, contraction member, etc., both (i) while aligned with the wire (in other words, parallel or coaxial with the wire) and (ii) while oriented perpendicular to the wire, line, contraction member, etc. This would allow, among other things, (i) advancement of the anchor along the wire, line, contraction member, etc., while aligned with the wire, line, contraction member, etc., during transcatheter delivery, and (ii) subsequent sliding of the wire, line, contraction member, etc., relative to the anchor after implantation, e.g., while the wire, line, contraction member, etc., is perpendicular to the anchor.

[0007] The tissue anchor can include (i) a tissue engaging element and (ii) a head at a proximal end of the tissue engaging element. The head can define an eyelet defining an aperture therethrough.

[0008] A variety of different tissue-engaging element configurations are possible. For some applications, the tissue-engaging element is shaped as a helix having an axis and forming a central lumen along the axis. For some applications, the tissue-engaging element may be pushed axially into the tissue, and in some circumstances may include barbs or barbed portions to hold the tissue-engaging element in the tissue. Other tissue-engaging elements or portions of the anchor are also possible.

[0009] For some applications, the central lumen of the helical-shaped tissue-engaging element is open at both ends, and the tissue anchor provides a straight channel aligned with the axis of the helix along the entire tissue anchor. In such applications, the eyelet is oriented perpendicular to the axis of the helix. During delivery, a wire, line, contraction member, etc. is aligned with the anchor and extends distally past the eyelet, through the anchor, through the lumen of the helix, and out the distal end of the lumen. In this state, the anchor can smoothly slide along the wire, line, contraction member, etc. while aligned with the wire, line, contraction member, etc. The anchor is anchored by rotation. As the helical tissue-engaging element rotates, it captures a portion of the wire, line, contraction member, etc. at the distal end of the lumen, eventually pulling it proximally toward the head so that the wire, line, contraction member, etc. no longer extends through the lumen of the helix, but instead extends through the eyelet. In this state, the anchor can slide smoothly along the wire, line, contraction member, etc. while crossing the wire, line, contraction member, etc. perpendicularly.

[0010] For some applications, the eyelet has a particular shape that allows for smooth sliding along a wire, line, contraction member, etc. both (i) when the anchor is parallel to the wire, line, contraction member, etc., and (ii) when the anchor is in an orthogonal orientation with respect to the wire, line, contraction member, etc. In each of these orientations, the eyelet forms a respective clear, straight pathway through the aperture of the eyelet for the passage of the wire, line, contraction member, etc. For some such applications, the shape and orientation of the eyelet are such that the aperture formed by the eyelet appears to be circular both (i) when viewed in an orientation parallel to the axis of the anchor, and (ii) when viewed in an orientation orthogonal to the axis of the anchor.

[0011] For some applications, one or more spacers are threaded over wires, lines, constrictors, etc. between the anchors. For some such applications, the spacers have flared ends and the eyelets of the anchors have one or more tapered portions, such that the flared ends and tapered portions interlock to provide secure and stable spacing of the anchors and / or force distribution between the anchors.

[0012] Some applications relate to systems, devices, and methods for determining successful (eg, complete) anchoring to tissue that is not in the line of sight, such as during percutaneous (eg, transluminal) procedures.

[0013] For some applications, the tissue anchor includes a tissue-engaging element and a head. An anchor driver can engage (e.g., reversibly attach to) the anchor at the head and drive the tissue-engaging element into the tissue. Often, successful anchoring includes the tissue-engaging element being sufficiently embedded in the tissue, e.g., such that the head abuts the surface of the tissue.

[0014] For some applications, the tissue anchor undergoes a conformational change upon successful anchoring, e.g., passively in response to the head pressing against the tissue. For some such applications, the conformational change is visible using imaging techniques, such as fluoroscopy. For example, a radiopaque element may change shape and / or change position relative to another portion of the anchor, which can be identified using imaging.

[0015] For some applications, one or more systems and / or apparatuses are provided that enable determination of successful (e.g., complete) anchoring to tissue that is not in the line of sight. Each tissue-indicating device is coupled to a distal tubular terminal portion of a flexible tube of a delivery tool used for implantation of the implant, which undergoes a conformational change from a resting state to a compressed state upon contact with tissue. The conformational change is visible using imaging techniques, such as fluoroscopy. For example, a radiopaque element may change shape in response to contact of the flexible tube with tissue, which can be identified using imaging.

[0016] For some applications, one or more systems and / or apparatuses are provided, each including a respective contraction member covering device coupleable to a contraction member (e.g., a wire, line, suture, etc.) coupled to a tissue anchor of the implant. The contraction member covering device includes a fastener configured to lock the contraction member in place after annuloplasty is performed by cinching. For some applications, the contraction member covering devices described herein are configured to expand to cover an excess portion of the contraction member and a free end of the contraction member. For some applications, the contraction member covering devices described herein are configured to change shape to cover an excess portion of the contraction member and a free end of the contraction member. For some applications, the contraction member covering devices described herein are configured to cover an excess portion of the contraction member and a free end of the contraction member by pulling the excess portion of the contraction member and the free end of the contraction member into a housing of the contraction member covering device.

[0017] For some applications, one or more systems and / or devices are provided, each including a locking mechanism having a fastener configured to be coupleable to a contraction member near a distal tissue anchor of the plurality of tissue anchors, the fastener configured to restrict movement of the contraction member relative to the plurality of tissue anchors in a closed state, and the locking mechanism is integrated with a cutting tool configured to cut the contraction member.

[0018] Therefore, according to an application, a system and / or device for use with an anchor driver is provided, the system and / or device including a wire, line, contraction member, etc., a first anchor, and a second anchor. Each of the first and second anchors may be configured to include a tissue engaging element forming a central longitudinal axis of the anchor, having a sharpened distal tip, and configured to be driven into tissue of a subject, and a head coupled to a proximal end of the tissue engaging element. For some applications, the head includes a driver interface configured to be reversibly engaged by the anchor driver and an eyelet forming an aperture through which the wire, line, contraction member, etc. is threaded. The eyelet may be disposed laterally from the central longitudinal axis and shaped to enable smooth sliding of the eyelet over the wire, line, contraction member, etc. along the sliding axis of the eyelet while the wire, line, contraction member, etc. is aligned with the sliding axis. For some applications, the eyelet also has an external shape forming a tapered portion that tapers away from the aperture along the sliding axis. For some applications, the tapered portion tapers over a distance of between 0.25 mm and 3 mm, between 0.5 mm and 2 mm, or about 1 mm. The taper can be in one direction or multiple (e.g., two or more) directions, such as tapering from a larger (e.g., wider, larger radius, etc.) center to a smaller (e.g., thinner, smaller radius, etc.) end.

[0019] In an application example, the external shape of the eyelet forms a tapered portion as a first tapered portion that tapers away from the aperture in a first taper direction along the slide axis, and a second tapered portion that tapers away from the aperture in a second taper direction along the slide axis, the second taper direction being opposite to the first taper direction.

[0020] In some applications, for each eyelet of the first and second anchors, the sliding axis is a second sliding axis. For example, in some applications, the eyelet has a first sliding axis that is parallel to the central longitudinal axis, and the second sliding axis is perpendicular to the first sliding axis. In some applications, the eyelet is shaped to allow smooth sliding of the eyelet over the wire, line, contraction member, etc. both (i) along the first sliding axis while the wire, line, contraction member, etc. is aligned with the first sliding axis, and (ii) along the second sliding axis while the wire, line, contraction member, etc. is aligned with the second sliding axis.

[0021] In some applications, the wire, line, constriction member, etc. has a thickness that is greater than 70 percent of the width of the aperture. In some applications, the thickness of the wire, line, constriction member, etc. is less than 90 percent of the length of the aperture.

[0022] For some applications, the system and / or device further includes a tubular spacer having a first spacer end, a second spacer end, and a central portion therebetween. For some applications, the spacer forms a spacer lumen between the first spacer end and the second spacer end, and a wire, line, contraction member, etc. is threaded over the spacer between the first anchor and the second anchor, with the first spacer end facing the first anchor and the second spacer end facing the second anchor. For some applications, the spacer lumen widens from the central portion toward the first spacer end, thereby shaped to snugly receive the tapered portion of the eyelet of the first anchor. The spacer lumen widens from the central portion toward the second spacer end, thereby shaped to snugly receive the tapered portion of the eyelet of the second anchor.

[0023] For applications, the spacer is configured to limit proximity between the first anchor and the second anchor. For applications, the spacer is resiliently flexible in deflection.

[0024] In some applications, the spacer is generally not axially compressible. In some applications, the spacer is formed by a helical wire shaped as a closed coil that defines a spacer lumen.

[0025] In an application, the spacer has a first flared zone in which the spacer lumen widens from the central portion toward the first spacer end and the outer diameter of the spacer increases from the central portion toward the first spacer end, and a second flared zone in which the spacer lumen widens from the central portion toward the second spacer end and the outer diameter of the spacer increases from the central portion toward the second spacer end.

[0026] In an application, the tissue engaging element is helical and defines a central longitudinal axis by extending helically around and along the central longitudinal axis, and is configured to be threaded into the tissue of a subject.

[0027] In some applications, the tissue engaging elements have a high friction surface, such as a knurled, textured, or barbed surface.

[0028] In some applications, the eyelet forms an aperture on the aperture surface, the aperture having a length along the aperture's major axis and a width along the aperture's minor axis. In some applications, the major and minor axes are disposed on the aperture surface, and the length is perpendicular to and greater than the width. The eyelet can also be mounted such that the aperture surface is tilted at a fixed angle relative to the central longitudinal axis.

[0029] In some applications, the tissue-engaging element is helical and defines a central longitudinal axis by extending helically about and along the central longitudinal axis, and is configured to be threaded into tissue of a subject, the helix inclined in the same direction as the aperture plane with respect to the central longitudinal axis. Other tissue-engaging elements, such as hooks, barbs, etc., and other shapes are also possible.

[0030] In an application, the eyelet is shaped and oriented so that the aperture appears circular both when viewed along a first line of sight that is parallel to the central longitudinal axis, and when viewed along a second line of sight that is perpendicular to the first line of sight.

[0031] In some applications, the aperture is shaped like a stadium. In some applications, the eyelet forms a rim around the aperture, the rim having a greater beveling on the major axis than on the minor axis.

[0032] In some applications, the minor axis is perpendicular to the central longitudinal axis and extends radially from the central longitudinal axis.

[0033] In some applications, the driver interface is disposed on a central longitudinal axis of the anchor.

[0034] In some applications, the length of the aperture is at least 1.4 times the width of the aperture. In some applications, the length of the aperture is 1.4 to 5 times the width of the aperture. In some applications, the length of the aperture is 1.4 to 3 times the width of the aperture. In some applications, the length of the aperture is 1.5 to 2.5 times the width of the aperture. In some applications, the length of the aperture is 1.6 to 2.2 times the width of the aperture. In some applications, the length of the aperture is 1.6 to 2 times the width of the aperture. In some applications, the length of the aperture is 1.6 to 1.8 times the width of the aperture.

[0035] In some applications, the eyelet is mounted so that the aperture face is inclined at 30 to 60 degrees relative to the central longitudinal axis. In some applications, the eyelet is mounted so that the aperture face is inclined at 40 to 50 degrees relative to the central longitudinal axis. In some applications, the eyelet is mounted so that the aperture face is inclined at 45 degrees relative to the central longitudinal axis.

[0036] In some applications, the system and / or device further includes an anchor driver.

[0037] In an application, the system and / or device includes a delivery tool including an anchor driver and a percutaneously advanceable tube (e.g., a catheter, etc.), and for each of the first and second anchors, the anchor driver and anchor are slidable through the tube while the anchor driver is engaged with the anchor.

[0038] For applications, the tube defines an internal channel having an orthogonal cross-section that defines a major channel region and a minor channel region in communication with the major channel region. The major channel region generally has a larger cross-sectional area than the minor channel region. For some applications, each of the first and second anchors is slidable through the channel, with the tissue engaging element and driver interface sliding through the major channel region and the eyelet sliding through the minor channel region.

[0039] In an application, the tissue engaging element fits snugly within the major channel region and the eyelet fits snugly within the minor channel region.

[0040] In an application, the eyelet is shaped to (i) fit snugly through the minor channel region while the wire, line, contraction member, etc. is disposed within the minor channel region and parallel to the central longitudinal axis, while (ii) allowing the eyelet to slide smoothly over the wire, line, contraction member, etc.

[0041] In some applications, each of the anchors is advanceable out of the distal opening of the tube. In some applications, the tube forms a lateral slit in the minor channel region, the lateral slit being continuous with and extending proximally from the distal opening of the tube. The lateral slit is generally dimensioned to allow a wire, line, contraction member, etc. to exit the tube laterally through the slit, but not to allow the first or second anchors to exit the tube laterally through the slit.

[0042] In some applications, the system and / or device further includes a tubular spacer threaded over a wire, line, contraction member, etc. between the first anchor and the second anchor such that when the first anchor and the second anchor are disposed in the interior channel of the tube, the spacer is disposed in the minor channel region.

[0043] In applications, the transverse slit is sized to allow the tubular spacer to exit the tube laterally through the slit.

[0044] In an application, the orthogonal cross section of the channel is keyhole shaped.

[0045] In an application, the orthogonal cross section of the channel has a double lobe shape.

[0046] In applications, in orthogonal cross section, the channel has a constricted neck between the major and minor channel regions.

[0047] In some applications, the system and / or device further includes a tubular spacer threaded over a wire, line, contraction member, etc. between the first anchor and the second anchor such that when the first anchor and the second anchor are disposed in the interior channel of the tube, the spacer is disposed in the minor channel region.

[0048] In applications, the constriction neck is sized to block the spacer from entering the major channel region.

[0049] In some applications, the eyelet is mounted so as to be pivotable or rotatable about a central longitudinal axis.

[0050] In an application, each of the first and second anchors is configured such that, for each of the first and second anchors, the eyelet remains disposed in the minor channel region and the driver interface is rotatable by the anchor driver while the anchor driver is engaged with the anchor within the internal channel.

[0051] In applications, the eyelet is mounted so that the aperture remains at a fixed angle relative to the central longitudinal axis but is pivotable or rotatable about the central longitudinal axis.

[0052] In an application, the head includes a ring surrounding a central longitudinal axis and rotatably coupled to the tissue engaging element, and the eyelet is mounted on the ring and is pivotable or rotatable about the central longitudinal axis by rotation of the ring about the central longitudinal axis.

[0053] According to an application, there is further provided a system and / or device including an anchor including a driver interface and an anchor driver including a shaft and a driver head coupled to a distal end of the shaft and configured to reversibly engage the driver interface.

[0054] For some applications, the anchor includes a helical tissue-engaging element that extends helically about a central longitudinal axis of the anchor to define a central longitudinal axis, has a sharpened distal tip, and is configured to be driven into tissue of a subject, and an anchor head coupled to a proximal end of the tissue-engaging element. The anchor head can include a driver interface. For some applications, other types, shapes, and configurations of anchors are possible.

[0055] For some applications, the system and / or device further includes a tube, such as a catheter. For some applications, the catheter is shaped to form a channel from a proximal portion of the catheter to a distal portion of the catheter and a distal opening at the distal portion of the catheter, where the channel terminates at the distal opening. For some applications, the anchor driver is configured to advance the anchor through the channel and out of the distal opening and to drive the tissue engaging element into the tissue, for example, by rotating the anchor, pushing the anchor into the tissue, etc.

[0056] In some applications, there is a spur in the distal portion of the catheter that protrudes inward into the channel in a manner that (i) prevents the tissue engaging element from passing distally through the spur in the absence of rotation of the tissue engaging element, and (ii) allows the tissue engaging element to thread distally past the spur.

[0057] For applications, the anchor head is sized so that the spar blocks axial passage of the anchor head over the spar in at least one rotational position of the head relative to the catheter.

[0058] For applications, the anchor head is dimensioned such that in at least one other rotational position of the head relative to the catheter, the anchor head is axially slidable over the spar.

[0059] In an application example, the anchor head forms a groove in its outer surface, the groove being parallel to the central longitudinal axis of the anchor and dimensioned so that the spar can slide along the groove when the anchor head is slid axially over the spar at other rotational positions of the head relative to the catheter.

[0060] For applications, the catheter includes a sidewall that forms a channel.

[0061] For some applications, the spar is reversibly transitionable between (i) an extended state in which the spar protrudes inwardly from the sidewall into the channel, and (ii) a retracted state in which the spar is at least partially retracted into the sidewall, wherein in the extended state the spar blocks distal passage of the anchor head therethrough, and in the retracted state the spar allows distal passage of the anchor head therethrough.

[0062] For applications, the catheter further includes a pull wire coupled to the spar and extending proximally from the spar along the sidewall, the spar being retractable into the sidewall by pulling the pull wire.

[0063] According to an application, there is further provided a system and / or device usable with or for use with the anchor driver, the system and / or device including an annulus-forming structure including a wire, a plurality of anchors, and a plurality of connectors.

[0064] Various anchor configurations are possible. Each of the anchors in the plurality of anchors includes a tissue-engaging element and a head. For some applications, the tissue-engaging element defines a central longitudinal axis of the anchor, has a sharpened distal tip, and is configured to be driven into tissue of a subject. For some applications, the tissue-engaging element may be pushed axially into the tissue, and in some circumstances, may include barbs or a barbed portion to retain the tissue-engaging element in the tissue. Other tissue-engaging elements or portions of the anchor are also possible. The head may be coupled to the tissue-engaging element via a neck. The head may include a driver interface configured to be reversibly engaged by an anchor driver.

[0065] For some applications, each of the plurality of connectors slidably couples a respective anchor of the plurality of anchors to a wire, line, contraction member, etc. For some applications, each of the plurality of connectors comprises or includes a flexible sheet. For some applications, the flexible sheet is shaped such that (i) a head of each anchor is disposed on a first side of the sheet, (ii) a tissue-engaging element of each anchor is on a second, or opposite, side of the sheet, and (iii) the neck of each anchor forms a hole extending therethrough such that the neck of each anchor is rotatable about the central longitudinal axis relative to the sheet by rotating within the hole.

[0066] For some applications, each of the plurality of connectors includes an eyelet, aperture, or other opening through which a wire, line, contraction member, etc. may be threaded, thereby slidably coupling the connector to the wire, line, contraction member, etc. In some applications, the eyelet is formed by a hem sewn into the flexible sheet.

[0067] In the application, the flexible sheet is a woven flexible sheet, although other materials are possible.

[0068] In an application, the wire, line, contraction member, etc. is a first wire, the loop-forming structure includes a second wire, and each of the connectors slidably couples a respective one of the anchors to the first wire and to the second wire.

[0069] In applications, the first wire and the second wire are generally parallel to one another.

[0070] In some applications, for each connector, the eyelet is a first eyelet, and a first wire is threaded through the first eyelet, thereby slidably coupling the connector to the first wire. In some applications, the sheet is also shaped to form a second eyelet, through which a second wire is threaded, thereby slidably coupling the connector to the second wire. In some applications, the flexible sheet is shaped to form a hole between the first eyelet and the second eyelet, such that a respective anchor is disposed between the first wire and the second wire.

[0071] Further, according to the application, a system and / or device including a tissue anchor usable with or for use with the anchor driver is provided. The anchor includes a tissue engaging element. The tissue engaging element defines a central longitudinal axis of the anchor having a sharpened distal tip and can be configured to be driven into tissue of a subject. For some applications, the tissue engaging element is configured to be driven axially into the tissue. For one application, the tissue engaging element is hook-shaped. For some applications, the tissue engaging element can include barbs or a barbed portion for holding the tissue engaging element in the tissue. Other tissue engaging elements or portions of the anchor are also possible.

[0072] The tissue anchor also includes a head coupled to the proximal end of the tissue engaging element. The head may include a driver interface configured for reversible engagement by an anchor driver and an eyelet or other connector (e.g., connectable to a wire, line, contraction member, tether, suture, etc.). The head may be combined with a variety of different tissue engaging element configurations.

[0073] For some applications, the eyelet or other connector forms an aperture in the aperture plane. For some applications, the aperture has a length along the aperture's major axis and a width along the aperture's minor axis, the major and minor axes being disposed on the aperture plane, and the length being perpendicular to and greater than the width. The eyelet / connector and / or aperture may be disposed laterally from the central longitudinal axis and mounted such that the aperture plane is tilted at a fixed angle relative to the central longitudinal axis.

[0074] For one application, the system and / or device includes an implant including an anchor and a wire, line, contraction member, etc. threaded through the aperture. For some applications, the eyelet / connector forms the aperture such that the eyelet has a first sliding axis parallel to the central longitudinal axis and a second sliding axis orthogonal to the first sliding axis. For some applications, the eyelet is shaped to allow smooth sliding of the eyelet (i) over the wire, line, contraction member, etc. along the first sliding axis while the wire, line, contraction member, etc. is aligned with the first sliding axis, and (ii) over the wire, line, contraction member, etc. along the second sliding axis while the wire, line, contraction member, etc. is aligned with the second sliding axis.

[0075] In one application, the eyelet has an exterior shape that forms a tapered portion that tapers away from the aperture along the second slide axis.

[0076] For some applications, the implant further includes a spacer having a tubular shape and a first spacer end, a second spacer end, and a central portion therebetween, the spacer having a spacer lumen formed between the first and second spacer ends. A wire, line, contraction member, or the like is threaded through the spacer lumen. For some applications, the spacer lumen widens from the central portion toward the first spacer end, thereby shaped to snugly receive the tapered portion of the eyelet.

[0077] In one application, the spacer is resiliently flexible in deflection, hi one application, the spacer is generally not axially compressible.

[0078] In one application, the spacer is formed by a helical wire shaped as a closed coil that defines the spacer lumen.

[0079] For one application, the spacer has a flared zone in which the spacer lumen widens from the central portion toward the first spacer end and the outer diameter of the spacer increases from the central portion toward the first spacer end.

[0080] In one application example, the anchor is a first anchor of an implant, and the implant further includes a second anchor including an eyelet having an external shape forming an aperture and forming a tapered portion, and a wire, line, contraction member, etc. is threaded through the aperture of the eyelet of the second anchor between the tapered portion of the eyelet of the first anchor and the tapered portion of the eyelet of the second anchor, such that the first spacer end faces the first anchor and the second spacer end faces the second anchor, and the spacer is disposed on the wire, line, contraction member, etc.

[0081] In one application, the spacer lumen widens from the central portion toward the second spacer end, thereby shaped to snugly receive the tapered portion of the eyelet of the second anchor.

[0082] For one application, the spacer is configured to limit proximity between the first anchor and the second anchor.

[0083] In one application, the exterior shape of the eyelet defines the tapered portions as a first tapered portion that tapers away from the aperture in a first taper direction along the second slide axis, and a second tapered portion that tapers away from the aperture in a second taper direction along the second slide axis, the second taper direction being opposite to the first taper direction.

[0084] In one application, the spacer is a first spacer of the implant, and the implant further includes a second spacer that is tubular and has a first spacer end, a second spacer end, and a central portion therebetween, forming a spacer lumen between the first spacer end and the second spacer end. A wire, line, contraction member, or the like is threaded through the spacer lumen of the second spacer such that the eyelet is disposed over the wire, line, contraction member, or the like between the first spacer end of the first spacer and the second spacer end of the second spacer. In some applications, the spacer lumen of the second spacer widens from the central portion of the second spacer toward the second spacer end of the second spacer, thereby shaped to snugly receive the second tapered portion of the eyelet.

[0085] In one application example, the eyelet is shaped and oriented so that the aperture appears circular both (i) when viewed along a first line of sight that is parallel to the central longitudinal axis, and (ii) when viewed along a second line of sight that is perpendicular to the first line of sight.

[0086] In one application, the aperture is shaped like a stadium, hi one application, the eyelet forms a rim around the aperture, the rim having a greater beveling on the major axis than on the minor axis.

[0087] For one application, the minor axis is perpendicular to the central longitudinal axis and extends radially from the central longitudinal axis. For one application, the driver interface is disposed on the central longitudinal axis of the anchor.

[0088] In one application, the length of the aperture is at least 1.4 times the width of the aperture. In one application, the length of the aperture is 1.4 to 5 times the width of the aperture. In one application, the length of the aperture is 1.4 to 3 times the width of the aperture. In one application, the length of the aperture is 1.5 to 2.5 times the width of the aperture. In one application, the length of the aperture is 1.6 to 2.2 times the width of the aperture. In one application, the length of the aperture is 1.6 to 2 times the width of the aperture. In one application, the length of the aperture is 1.6 to 1.8 times the width of the aperture.

[0089] In one application, the eyelet is mounted so that the aperture face is inclined at 30 to 60 degrees relative to the central longitudinal axis. In one application, the eyelet is mounted so that the aperture face is inclined at 40 to 50 degrees relative to the central longitudinal axis. In one application, the eyelet is mounted so that the aperture face is inclined at 45 degrees relative to the central longitudinal axis.

[0090] In one application, the eyelet is mounted to be pivotable or rotatable about the central longitudinal axis while the aperture face remains tilted at a fixed angle relative to the central longitudinal axis.

[0091] In one application, the head includes a ring surrounding a central longitudinal axis and rotatably coupled to the tissue engaging element, and the eyelet is mounted on the ring and is rotatable or rotatable about the central longitudinal axis by rotating the ring about the central longitudinal axis.

[0092] In one application, the system and / or device further includes an anchor driver.

[0093] In one application, the system and / or device includes a delivery tool including an anchor driver and a percutaneously advanceable tube, wherein the anchor driver and anchor are slidable through the tube while the anchor driver is engaged with the anchor.

[0094] In one application example, the tube forms an internal channel with a keyhole-shaped orthogonal cross-section that forms a major channel region and a minor channel region, the major channel region having a larger cross-sectional area than the minor channel region, the anchor is slidable through the channel, the tissue engaging element slides snugly through the major channel region, and the eyelet slides snugly through the minor channel region.

[0095] In one application example, the system and / or device includes an implant including a wire, line, contraction member, etc., and a tissue anchor, and the eyelet is shaped to simultaneously allow smooth sliding of the eyelet (i) snugly through the minor channel region and (ii) through the wire, line, contraction member, etc., while the wire, line, contraction member, etc. is disposed within the minor channel region and parallel to the central longitudinal axis.

[0096] In one application, the eyelet is shaped to allow smooth sliding of the eyelet over the wire, line, contraction member, etc. while the wire, line, contraction member, etc. is oriented perpendicular to the central longitudinal axis.

[0097] In one application, the anchor is advanceable from the distal end of the tube, and the tube forms a lateral slit extending proximally from the distal end of the tube, the slit being adjacent to the minor channel region, and the slit allows a wire, line, contraction member, etc., but not the anchor, to exit the tube laterally proximally from the distal end of the tube.

[0098] In one application, the system and / or device includes an implant including a wire, line, contraction member, etc., and a tissue anchor, and the eyelet is shaped to allow the wire, line, contraction member, etc. to slide smoothly through the aperture both (i) while the wire, line, contraction member, etc. is parallel to the central longitudinal axis, and (ii) while the wire, line, contraction member, etc. is oriented perpendicular to the central longitudinal axis.

[0099] In one application, the wire, line, constriction member, etc. has a thickness that is greater than 70% of the width of the aperture. In one application, the thickness of the wire, line, constriction member, etc. is less than 90% of the length of the aperture.

[0100] For one application, the tissue engaging element is helical, defines a central longitudinal axis by extending helically around and along the central longitudinal axis, and is configured to be threaded into tissue of a subject, although other tissue engaging element configurations are possible.

[0101] In one application, the helix is ​​inclined in the same direction as the aperture face relative to the central longitudinal axis.

[0102] Depending on the application, a system and / or device including a tissue anchor usable with or for use with the anchor driver is also provided, the tissue anchor including a tissue engaging element and a head coupled to a proximal end of the tissue engaging element.

[0103] For some applications, the tissue engaging element defines a central longitudinal axis of the anchor, has a sharpened distal tip, and is configured to be driven into tissue of a subject.

[0104] For some applications, the head includes a driver interface configured for reversible engagement by an anchor driver and an eyelet or other connector. The eyelet or connector can be configured to form an aperture, can be disposed laterally from the central longitudinal axis, and can be mounted such that the aperture is at a fixed angle relative to the central longitudinal axis. The eyelet / connector and aperture can be shaped to form (i) a first clear, straight pathway through the opening along a first line that is parallel to the central longitudinal axis, and (ii) a second clear, straight pathway through the aperture along a second line that is orthogonal to the first line.

[0105] In one application, the eyelet is shaped so that the aperture appears circular both when viewed along (i) a first line and when viewed along (ii) a second line.

[0106] In one application, the eyelet is mounted so as to be pivotable or rotatable about the central longitudinal axis while remaining at a fixed angle relative to the central longitudinal axis.

[0107] In one application, the fixed angle is inclined relative to the central longitudinal axis, and the eyelet forms an aperture on an aperture surface that is inclined at the fixed angle relative to the central longitudinal axis.

[0108] In one application, the aperture has a length along a major axis of the aperture and a width along a minor axis of the aperture, the major and minor axes being disposed in the aperture plane, and the length being perpendicular to and greater than the width.

[0109] In one application, the length of the aperture is at least 1.4 times the width of the aperture. In one application, the length of the aperture is 1.4 to 5 times the width of the aperture. In one application, the length of the aperture is 1.4 to 3 times the width of the aperture. In one application, the length of the aperture is 1.5 to 2.5 times the width of the aperture. In one application, the length of the aperture is 1.6 to 2.2 times the width of the aperture. In one application, the length of the aperture is 1.6 to 2 times the width of the aperture. In one application, the length of the aperture is 1.6 to 1.8 times the width of the aperture.

[0110] In one application, the eyelet is mounted so that the aperture face is inclined at 30 to 60 degrees relative to the central longitudinal axis. In one application, the eyelet is mounted so that the aperture face is inclined at 40 to 50 degrees relative to the central longitudinal axis. In one application, the eyelet is mounted so that the aperture face is inclined at 45 degrees relative to the central longitudinal axis.

[0111] According to applications, there are further provided systems and / or devices including a tissue anchor usable with or for use with the anchor driver, a tissue anchor including a tissue engaging element, and a head coupled to a proximal end of the tissue engaging element. For some applications, the tissue engaging element defines a central longitudinal axis of the anchor, has a sharpened distal tip, and is configured to be driven into tissue of a subject. For some applications, the tissue engaging element is configured to be driven into tissue rather than rotated. For some applications, the tissue engaging element is hook-shaped, straight, angled, and / or has another configuration. For some applications, the tissue engaging element may include barbs or a barbed portion for holding the tissue engaging element in tissue. Other tissue engaging elements or portions of the anchor are also possible.

[0112] For some applications, the head includes a driver interface configured to be reversibly engaged by an anchor driver. For some applications, the protrusion protrudes distally away from the head, thereby driving the tissue engaging element into the tissue, thereby pressing the protrusion against the tissue. For some applications, the protrusion is fixed in position. For some applications, the protrusion is configured to automatically move relative to the head in response to being pressed against the tissue.

[0113] For one application, the driver interface is rigidly coupled to the tissue coupling element.

[0114] For one application, the prongs are configured to automatically move proximally relative to the head in response to being pressed against tissue, hi one application, the prongs are configured to automatically move resiliently relative to the head in response to being pressed against tissue.

[0115] For one application, the protrusions extend distally beyond at least a proximal end of the tissue engaging element and are disposed laterally outward from the tissue engaging element. For one application, the protrusions extend distally beyond at least a proximal end of the tissue engaging element and extend circumferentially at least partway around the tissue engaging element. For one application, the protrusions extend distally beyond at least a proximal end of the tissue engaging element and are disposed inward from the tissue engaging element.

[0116] For one application, the tissue-engaging element is helical and extends helically around the protrusion. For some applications, the tissue-engaging element is configured to be at least one of rotated and / or driven into tissue. For some applications, the tissue-engaging element is hook-shaped, straight, angled, and / or otherwise configured. For some applications, the tissue-engaging element includes barbs or barbed portions for holding the tissue-engaging element in tissue. Other tissue-engaging elements or portions of the anchor are also possible.

[0117] In one application, the protrusions are radiopaque.

[0118] In one application, the prongs are configured to automatically bend in response to being pressed against tissue.

[0119] For one application, the tissue-engaging element is helical, defining a central longitudinal axis by extending helically around and along the central longitudinal axis, and configured to be threaded into the subject's tissue. For some applications, the tissue-engaging element is configured to be at least one of rotated and / or driven into the tissue. For some applications, the tissue-engaging element is hook-shaped, straight, angled, and / or otherwise configured. For some applications, the tissue-engaging element may include barbs or barbed portions for holding the tissue-engaging element in the tissue. Other tissue-engaging elements or portions of the anchor are also possible.

[0120] For one application, the prongs are configured to reversibly move in response to being pressed against tissue.

[0121] For one application, the protrusion includes a spring. For one application, the spring is a helical compression spring that extends helically around at least a portion of the tissue engaging element. For one application, the helical compression spring forms multiple turns around the portion of the tissue engaging element.

[0122] In one application, the helical compression spring forms one or less complete turns, and in response to being pressed against tissue, a first end of the helical compression spring becomes aligned with a second end of the helical compression spring along the central longitudinal axis.

[0123] In one application, the system and / or device further includes a spring operatively coupled between the protrusion and the head to bias or configure the protrusion to reversibly move in response to the protrusion being pressed against tissue.

[0124] In one application, the tissue anchor includes a head and a cuff extending at least partway about a central longitudinal axis, a distal portion of the cuff protruding distally away from the head to form a protrusion, and a spring operatively couples the cuff to the head such that the cuff is configured to automatically move proximally relative to the head in response to the distal portion of the cuff being pressed against tissue.

[0125] In one application, the spring includes a plurality of angle-shaped spring elements oriented circumferentially about a central longitudinal axis.

[0126] In one application, the tissue anchor is configured for use with a wire, line, contraction member, etc. In one application, the tissue anchor further includes a ring and an eyelet, where the ring surrounds the central longitudinal axis and is rotatably coupled to the tissue engaging element. The eyelet / connector can be configured to facilitate sliding of the wire / line / etc., can be mounted on the ring, and can be pivotable or rotatable about the central longitudinal axis by rotating the ring about the central longitudinal axis. A cuff can be coupled to the ring.

[0127] In one application, a proximal portion of the head protrudes proximally from the cuff, and the cuff is dimensioned such that moving the cuff proximally relative to the head causes the proximal portion of the cuff to conceal the proximal portion of the head.

[0128] In one application, the cuff is radiopaque.

[0129] In one application, the system and / or device further includes one or more radiopaque indicators extending proximally from the cuff, the cuff being dimensioned such that moving the cuff proximally relative to the head causes the one or more indicators to move proximally beyond a proximal portion of the head.

[0130] For one application, the protrusion includes a post configured to slide axially proximally relative to the head in response to being pressed against tissue.

[0131] In one application, the post includes a first post, the spring includes a first spring, and the system and / or device further includes a second post configured to slide axially proximally relative to the head in response to being pressed against tissue.

[0132] For one application, the system and / or device further includes an anchor driver. The anchor driver is configured to drive the tissue engaging element into tissue while reversibly engaged with the driver interface. For some applications, the anchor driver includes a pressure sensor at a distal end of the anchor driver. The protrusion can include a post configured to move proximally relative to the head and press against the pressure sensor in response to being pressed against tissue. The pressure sensor is configured to provide a signal in response to being pressed.

[0133] For one application, the anchor driver includes a wire extending from the pressure sensor to a proximal portion of the anchor driver, the pressure sensor being configured to transmit a signal via the wire.

[0134] For one application, the post is configured to slide axially proximally relative to the head in response to being pressed against tissue.

[0135] Further, according to applications, a system and / or device is provided that includes a tissue anchor having an eyelet. For some applications, the tissue anchor includes a helical tissue-engaging element. For some applications, the helical tissue-engaging element has a proximal end and a distal end and forms a central lumen along a central longitudinal axis of the tissue anchor. For some applications, the eyelet is configured to widen laterally across the proximal end of the tissue-engaging element and extend proximally away from the tissue-engaging element, thereby forming bilaterally opposed apertures proximally from the tissue-engaging element.

[0136] In one application, the tissue anchor is a first tissue anchor of a plurality of tissue anchors, and the system and / or device includes an annuloplasty implant including the plurality of tissue anchors, and a wire, line, contraction member, etc. threaded therethrough.

[0137] In one application, the system and / or device includes an implant including a wire, line, contraction member, etc., and a tissue anchor, and the system and / or device further includes a delivery tool for percutaneous implantation of the implant, the delivery tool including an anchor driver. An anchor driver is reversibly coupled to the eyelet; a wire, line, contraction member, etc. extending longitudinally through the lumen such that the anchor is freely slidable along the wire, line, contraction member, etc.; The delivery device and implant are percutaneously advanceable into the subject; It has a transport state.

[0138] In some applications, the delivery tool is configured to transition the system and / or device to an implanted state by the anchor driver rotating the tissue anchor so that the tissue binding element is driven into the subject's tissue, and the wire, line, contraction member, etc. is pulled proximally along the helical element until the wire, line, contraction member, etc. exits the lumen and extends laterally through the aperture.

[0139] In one application example, the tissue anchor is a first tissue anchor of a plurality of tissue anchors, and the implant includes a plurality of tissue anchors, wherein a wire, line, contraction member, etc. extends longitudinally through a lumen of each tissue anchor of the plurality of tissue anchors, such that each of the tissue anchors is freely slidable along the wire, line, contraction member, etc.

[0140] For one application, the tissue anchor includes a rod having a sharpened distal tip, a first portion extending from the distal tip to a transition region of the rod, and a second portion continuous with the first portion and extending from the transition region to a second tip of the rod. For some applications, the tissue-engaging element is formed by the first portion of the rod extending helically around and along a central longitudinal axis of the anchor, and the eyelet is formed, at least in part, by the second portion of the rod forming an arch that spans laterally across a proximal end of the tissue-engaging element and arches proximally away from the tissue-engaging element.

[0141] In one application, the system and / or device includes an implant including a wire, line, contraction member, etc. and a tissue anchor, and the system and / or device further includes a delivery tool for percutaneous implantation of the implant, the delivery tool including a tube and an anchor driver. In some applications, the anchor driver is reversibly coupled / couplable to the eyelet, the anchor is disposed within the tube, and the wire, line, contraction member, etc. extends through the tube and extends longitudinally through the lumen such that the anchor can be freely slid by the anchor driver along the wire, line, contraction member, etc. The delivery tool and implant are percutaneously advanceable into a subject.

[0142] In one application, the rod is shaped so that the eyelet and the proximal turn of the helical tissue-engaging element jointly form a closed loop, and a wire, line, contraction member, etc. extends distally through the closed loop and lumen such that the anchor is freely slidable by the anchor driver along the wire, line, contraction member, etc.

[0143] In one application, the eyelet has a transverse thickness that is less than two-thirds the transverse diameter of the lumen.

[0144] For one application, the eyelet is at least partially formed by attaching the second tip of the rod to an attachment site on the rod, the attachment site being within the first portion of the rod.

[0145] For one application, the tissue engaging element includes a plurality of helical turns of the rod. For one application, the plurality of helical turns of the rod include a distal-most helical turn defined distally by a distal tip of the rod and a proximal-most helical turn defined proximally by a transition region. For one application, a second tip of the rod is attached to an attachment site of the rod, the attachment site being midway around the proximal-most helical turn.

[0146] In one application, the second tip of the rod is attached to an attachment site on the rod, the attachment site being at least one-third of the way around the most proximal helical turn.

[0147] Further, according to applications, a system and / or apparatus is provided that includes an anchor delivery tube having a distal tubular terminal portion and a tissue viewing device coupled to the distal tubular terminal portion of the anchor delivery tube. For some applications, the tissue viewing device includes a radiopaque material shaped to form a tubular body having a central longitudinal axis and configured for placement in contact with the annulus of a subject's native heart valve, the tubular body including a compressible element. For some applications, the tissue viewing device is compressible to a compressed state in response to contact with tissue of the native heart valve and expandable from the compressed state in the absence of force applied to the tissue viewing device.

[0148] The system may also include one or more tissue anchors or at least one tissue anchor for implantation along the subject's valve annulus.

[0149] For some applications, the tissue viewing device is configured to provide a guide for implantation of the tissue anchor along the valve annulus during implantation of the tissue anchor and is removable following implantation of the tissue anchor.

[0150] In one application, the tissue viewing device is shaped to form a tubular stent body.

[0151] For one application, the tissue indicating device includes a superelastic material. For one application, the compressible element includes a coiled element. For one application, the compressible element includes a spring. For one application, the compressible element includes a strut element compressible along a longitudinal axis of the anchor delivery tube.

[0152] In one application, the tissue display device comprises: a proximal tube element; a distal tube element; and a connecting element connecting the proximal and distal tube elements; Including, The distal tube element is spaced a first distance from the proximal tube element during a resting state of the tissue display device, and the distal tube element is spaced a second distance from the proximal tube element during a compressed state of the tissue display device, the second distance being shorter than the first distance.

[0153] In one application, the proximal tube element is fixedly coupled to the distal tubular terminal portion of the anchor delivery tube.

[0154] For one application, the linking element includes a coiled element, hi one application, the linking element includes a spring, hi one application, the linking element includes a strut element.

[0155] In one application example, the connecting element includes first and second scaffold elements, at least a portion of each of the first and second scaffold elements being spaced apart from each other during a resting state of the tissue display device, and at least a portion of each of the first and second scaffold elements being moved toward each other during a compressed state of the tissue display device.

[0156] In one application, during the rest state of the tissue-viewing device, the tissue-viewing device assumes a first height, and during the compressed state, the tissue-viewing device assumes a second height that is shorter than the first height.

[0157] In one application example, the proximal tube element and connecting element surround the distal tubular terminal portion of the anchor delivery tube, and the connecting element is compressible proximally in the longitudinal direction along the distal tubular terminal portion of the anchor delivery tube, pulling the distal tube element toward the proximal tube element.

[0158] In one application, the proximal tube element is fixedly coupled to the distal tubular terminal portion of the anchor delivery tube.

[0159] In one application example, a proximal tube element surrounds the distal tubular terminal portion of the anchor tube, and a connecting element is disposed distally relative to the distal end of the anchor delivery tube and is longitudinally compressible proximally to pull the distal tube element toward the proximal tube element.

[0160] In one application, the proximal tube element is fixedly coupled to the tubular distal end portion of the anchor delivery tube.

[0161] In one application example, the compressible element includes a plurality of struts arranged in a braided arrangement, and during a resting state of the tissue display device, the tissue display device assumes a first height, and during a compressed state, the tissue display device assumes a second height that is shorter than the first height.

[0162] In one application, during the compressed state, the tissue viewing device shortens longitudinally and expands radially.

[0163] For one application, the plurality of struts includes a subset of struts that are rounded at a distal end of the tissue viewing device.

[0164] In one application, the at least one tissue anchor includes a plurality of tissue anchors, and the system and / or device further includes a contraction member (e.g., a wire, line, suture, etc.) slidably coupled to the plurality of tissue anchors, each of the plurality of tissue anchors and contraction member configured for delivery through the anchor delivery tube.

[0165] In one application, the distal tubular terminal portion of the anchor delivery tube is shaped to form a lateral slit extending proximally from the distal end of the anchor delivery tube, the slit allowing the contraction member to exit the anchor delivery tube laterally, proximally from the distal end of the tube, but not the tissue anchor.

[0166] In one application, the tissue viewing device is shaped to form a slit aligned with and disposed within the transverse slit of the anchor delivery tube.

[0167] According to an application, there is further provided a system and / or device including a plurality of tissue anchors, a contraction member (e.g., a wire, line, suture, etc.) slidably coupled to the plurality of tissue anchors, and a fastener configured to be coupleable to the contraction member near a distal tissue anchor of the plurality of tissue anchors, the fastener in a closed or locked state being configured to restrict movement of the contraction member relative to the plurality of tissue anchors.

[0168] For some applications, the system and / or apparatus includes a contraction member covering device coupleable to the contraction member near the terminal tissue anchor, the contraction member covering device configured to cover an excess portion of the contraction member following (a) implantation of the terminal anchor, (b) transitioning the fastener to a closed state, and (c) cutting the contraction member proximal to the terminal anchor.

[0169] In one application, the fastener is separate from the contraction member covering device.

[0170] For one application, the contractile member includes a metal wire.For one application, the contractile member covering device is configured to cover a free end of the contractile member.

[0171] For one application, the contractile member covering device includes a housing, with the contractile member passing longitudinally through the housing. In some applications, the housing includes at least first and second flexible wires passing laterally through the housing and along a portion of the contractile member, the first and second wires being transitionable to (1) a first position in which the first and second flexible wires do not engage the contractile member and (2) a second position in which the first and second wires are flexible to assume a configuration that alters the fit of a portion of the contractile member in a manner that draws additional portions of the contractile member into the housing.

[0172] In one application, the system and / or device further includes a tube positionable between the contraction member and the first and second flexible wires in the first position, the tube configured to (1) restrict the first and second flexible wires from transitioning to the second position, and (2) removable from within the housing to allow the first and second flexible wires to transition to the second position.

[0173] In application, in the first position, at least a majority of the first flexible wire is disposed above a portion of the contraction member and at least a majority of the second flexible wire is disposed below a portion of the contraction member.

[0174] For one application, in the second position, at least a majority of the first deflectable wire pushes down on a portion of the contraction member and at least a majority of the second deflectable wire pushes up on a portion of the contraction member.

[0175] In one application, in the first position, the first and second flexible wires assume a loaded configuration in which each of the first and second flexible wires assumes a curved configuration, and in the second position, the first and second flexible wires assume a straight configuration.

[0176] In one application example, in the second position, the first and second flexible wires each have a length greater than the width of the housing, and the first and second flexible wires each form at least one crimping region configured to shorten the length of the first and second flexible wires in the second position.

[0177] In one application, the contraction member covering device includes a housing, with the contraction member passing through the housing and through an opening in the housing.

[0178] In one application, the contraction member covering device includes an expandable fabric coupled to the housing near the opening, the expandable fabric configured to expand to cover an excess portion of the contraction member exiting the housing through the opening.

[0179] In one application, the contraction member covering device includes a spring coupled to the housing near the opening, the spring configured to expand to cover an excess portion of the contraction member that exits the housing through the opening.

[0180] In one application, the spring includes a metal spring covered with a fabric.

[0181] In one application, the spring includes first and second scaffolding elements disposed opposite each other, the first and second scaffolding elements configured to expand laterally in a direction away from a wall of the housing that forms the aperture.

[0182] In one application, the system and / or apparatus further includes a carrier configured to carry the housing, wherein when the carrier is coupled to the housing, the carrier applies a force to the housing to compress the spring, and when the carrier is separated from the housing, the spring is allowed to expand.

[0183] In one application, the fastener is disposed within a housing.

[0184] In one application, the fastener includes a clamping structure that can be biased toward a closed state in which (a) the clamping structure is configured to clamp onto a contraction member that has passed through the housing, and (b) the clamping structure can be deflected to an open state in which the contraction member is movable relative to the housing.

[0185] In one application, the system and / or apparatus further includes a carrier configured to transport the housing, the carrier further including a stop removably coupled to the fastener and configured to maintain the fastener in an open state.

[0186] In one application, the system and / or apparatus further includes a contraction member cutting tool including a movable cutting element having a sharp edge, and movement of the stop strikes the stop against the movable cutting element such that movement of the movable cutting element severs the contraction member.

[0187] For one application, the contraction member covering device is configured to pull an excess portion of the contraction member within the housing.

[0188] In one application example, the contraction member covering device includes a spiral spring movable along a path, the contraction member passing by an end of the spiral spring, and the spiral spring being movable in a spiral manner to push the contraction member along the path and in a direction away from the opening of the housing using the end of the spiral spring.

[0189] In one application, an end of the spiral spring includes a crossbeam, the crossbeam configured to push the contraction member along the path.

[0190] For one application, the fastener is disposed within the housing, and the system and / or apparatus further includes a carrier configured to transport the housing. For some applications, the carrier further includes a stop removably coupled to the fastener, the stop configured to (a) maintain the fastener in an open state when the carrier is coupled to the housing, and (b) the crossbeam configured to maintain the crossbeam in a position that does not engage the contraction member, the crossbeam configured to push the contraction member along the path in the absence of the stop.

[0191] In one application example, the contraction member covering device includes a flap disposed on the exterior of the housing, the flap being movable from (1) an open state in which the flap is moved away from the housing to (2) a closed state in which the flap is disposed near the housing in a manner in which the flap presses an excess portion of the contraction member exiting the housing through the opening and the end of the contraction member against the exterior surface of the housing.

[0192] In one application, the flap includes two metal scaffolding beams disposed opposite each other.

[0193] In one application example, one fabric is coupled to two metal scaffolding girders and extends between the two metal scaffolding girders in a manner that, when the flap is in a closed state, the fabric covers the excess portion of the contraction member and the ends of the contraction member.

[0194] In one application example, the flap further includes a cross beam extending between the two metal scaffolding beams, and when the flap is in a closed state, the cross beam presses the excess portion of the contraction member that exits the housing through the opening and the end of the contraction member against the outer surface of the housing.

[0195] According to an application example, a system and / or device is further provided that includes a plurality of tissue anchors, a contraction member (e.g., a wire, line, suture, etc.) slidably coupled to the plurality of tissue anchors, and a fastener configured to be connectable to the contraction member near a distal tissue anchor of the plurality of tissue anchors, the fastener being configured to restrict movement of the contraction member relative to the plurality of tissue anchors in its closed state.

[0196] For some applications, the fastener includes a housing shaped to define (a) a first lumen for passage of the contraction member, the first lumen being along a longitudinal axis of the housing, and (b) a second lumen disposed at a non-zero angle relative to the first lumen. For some applications, the locking ball is movable within the second lumen from a first position in which the locking ball does not apply pressure to the contraction member to a second position in which the locking ball applies pressure to the contraction member to restrict movement of the contraction member.

[0197] For some applications, an advancement pin is disposed in the second lumen proximal to the locking ball and configured to advance the locking ball from the first position to the second position. In one application, in the second position, the locking ball is configured to contact a portion of the retraction member.

[0198] For one application, the second lumen is in fluid communication with a portion of the first lumen.

[0199] In one application, the second lumen has a threaded surface and the advancement pin has a threaded outer surface, the threaded surface enabling locking of the locking ball in the second position.

[0200] In one application, the second lumen has a first sublumen sized to accommodate the advancement pin and a second sublumen sized to accommodate the locking ball, the first sublumen disposed proximally to the second sublumen.

[0201] For one application, the system and / or apparatus further includes a delivery tool configured to deliver the fastener along the contraction member and to apply a torque to the advancement pin.

[0202] According to an application example, there is further provided a system and / or device including a plurality of tissue anchors, a contraction member (e.g., a wire, line, suture, etc.) slidably coupled to the plurality of tissue anchors, and a fastener configured to be coupled to the contraction member near a distal tissue anchor of the plurality of tissue anchors, the fastener in a closed state being configured to restrict movement of the contraction member relative to the plurality of tissue anchors.

[0203] For some applications, the fastener includes a housing shaped to form a lumen for passage therethrough, and a retraction member lock and cutter element slidable within the lumen of the housing. For some applications, the retraction member lock and cutter element include first and second arms coupled together at their respective distal portions at distal portions of the retraction member lock and cutter element, the first and second arms compressible toward each other when the retraction member lock and cutter element are advanced within the lumen of the housing such that the retraction member lock and cutter element assume a closed state.

[0204] For some applications, each of the first and second arms is shaped to define a respective cutting element at a proximal end of each of the first and second arms and a respective protrusion at an intermediate portion of each of the first and second arms.

[0205] For some applications, there is also a pusher configured to push the retraction member lock and cutter element into the lumen of the housing, hi some applications, the retraction member passes through the lumen of the housing, through an opening formed by the distal portion of the retraction member lock and cutter element, and through an opening formed by the pusher.

[0206] For some applications, the wall of the housing lumen presses against the first and second arms of the retraction member lock and cutter element such that the first and second arms compress toward one another when the retraction member lock and cutter element are pushed into the housing lumen. For some applications, in the closed state, (a) the respective cutting elements of the retraction member lock and cutter element come together to cut the retraction member, and simultaneously, (b) the respective protrusions of the retraction member lock and cutter element come together to compress the retraction member therebetween and restrict movement of the retraction member, thereby enabling locking of the retraction member.

[0207] For one application, the housing is configured to cover the free end of the contraction member following cutting by the cutting element.

[0208] According to an application, there is further provided a system and / or device including a plurality of tissue anchors, a contraction member (e.g., a wire, line, suture, etc.) slidably coupled to the plurality of tissue anchors, and a fastener configured to be coupleable to the contraction member proximate a distal tissue anchor of the plurality of tissue anchors, the fastener configured to restrict movement of the contraction member relative to the plurality of tissue anchors in its closed state.

[0209] For some applications, the fastener includes a housing including an inner wall shaped to form (a) a lumen for passage through the retraction member, (b) a distal conical surface, and (c) a threaded inner wall proximal portion. For some applications, the fastener also includes a threaded driving element having a threaded surface engageable with the threaded proximal portion of the inner wall of the housing and longitudinally threadable within the lumen of the housing.

[0210] For some applications, the retraction member lock is coupled to the threaded advancing element and movable within the lumen of the housing in response to threaded advancement of the threaded advancing element. For some applications, the retraction member lock includes first and second gripping elements disposed on either side of the retraction member, each of the first and second gripping elements forming a tapered surface configured to (1) engage within a distal conical surface of the housing in response to distal advancement of the threaded advancing element pushing the retraction member lock distally, and thereby (2) compress the retraction member passing through the first and second gripping elements.

[0211] In one application, the housing is configured to cover the free end of the contraction member following severing of the contraction member.

[0212] According to an application, there is further provided a system and / or device including a plurality of tissue anchors, a contraction member (e.g., a wire, line, suture, etc.) slidably coupled to the plurality of tissue anchors, and a fastener configured to be coupleable to the contraction member proximate a distal tissue anchor of the plurality of tissue anchors, the fastener configured to restrict movement of the contraction member relative to the plurality of tissue anchors in its closed state.

[0213] For some applications, the fastener includes a housing including an inner wall shaped to form a lumen for passage therethrough of the constriction member. The lumen may be partially shaped to form a conical surface having a wide proximal portion and a narrow distal portion having a narrow surface at a distal end of the conical surface.

[0214] For some applications, the fastener includes a distal spring coupling element at a distal end of the lumen and a proximal spring coupling element at a proximal end of the lumen and disposed proximal to the conical surface. A spring can be coupled to the distal and proximal spring coupling elements.

[0215] For some applications, at least one inwardly compressible element is coupled to the spring at a location along the spring that is disposed within the space formed by the conical surface, and the at least one inwardly compressible element is disposed near the contraction member.

[0216] In some applications, in the open state of the fastener, the proximal spring coupling element is in a proximal position in which the spring is pulled to an extended state between the proximal and distal spring coupling elements and at least one inwardly compressible element is disposed in the space formed by the wide portion of the conical surface and does not exert inward pressure on the contraction member.

[0217] For some applications, in the closed state of the fastener, the proximal spring coupling element is in a distal position where the spring is in a relaxed state and at least one inwardly compressible element is disposed in a narrow portion of the conical surface and applies inward pressure to the contraction member in response to pressure applied to the at least one inwardly compressible element by the narrow surface of the conical surface.

[0218] In one application, the proximal spring coupling element is shaped to form a threaded coupling site for coupling of a tool thereto that maintains the fastener in an open state, and upon separation of the tool from the proximal spring coupling element by unscrewing it, the spring returns to its rest state and the fastener assumes a closed state.

[0219] In one application, the spring is shaped to form at least one slit for inward movement of at least one internally compressible element.

[0220] For one application, the at least one inwardly compressible element includes a plurality of inwardly compressible spheres surrounding the contraction member.

[0221] For one application, the housing is configured to cover the free end of the contraction member following severing of the contraction member.

[0222] According to some applications, there is further provided a method including positioning an anchor delivery tube having a distal tubular terminal portion against tissue of a subject's valve annulus, the distal tubular terminal portion being coupled to a tissue viewing device. In some applications, the tissue viewing device includes a radiopaque material shaped to form a tubular body having a central longitudinal axis and configured for placement in contact with the subject's native heart valve annulus. The tubular body includes a compressible element.

[0223] In some applications, the tissue display device is compressible to a compressed state in response to contact with tissue of the native heart valve and expandable from the compressed state in the absence of a force applied to the tissue display device.

[0224] For some applications, the method further includes determining the presence of tissue by pressing the compressible element against tissue and imaging the compressed state of the compressible element.

[0225] For some applications, the method includes, in response to the determining, implanting at least one tissue anchor along the subject's valve annulus while using the tissue display device as a guide for implantation of the tissue anchor along the annulus.

[0226] For some applications, the method also includes removing the tissue viewing device following the step of implanting the tissue anchor.

[0227] For some applications, implanting the at least one tissue anchor includes implanting at least two tissue anchors coupled together by a contraction member (e.g., a wire, line, suture, etc.), and the method further includes allowing the contraction member, but not the tissue anchors, to laterally exit the anchor delivery tube proximally from the distal end of the tube through a lateral slit extending proximally from the distal end of the anchor delivery tube. The above method can be performed in a live animal or a simulation such as a cadaver, cadaver heart, simulator (e.g., in which a body part, heart, tissue, etc. is simulated), etc.

[0228] Further, according to an application example, a method is provided that includes implanting an implant into a cardiac annulus of a patient, the implant including: (1) a plurality of tissue anchors; and (2) a contraction member (e.g., a wire, line, suture, etc.) slidably coupled to the plurality of tissue anchors.

[0229] For some applications, the method also includes restricting movement of the contraction member relative to the plurality of tissue anchors by coupling a fastener to the contraction member near a distal tissue anchor of the plurality of tissue anchors.

[0230] For some applications, the method includes severing the contraction member after the restricting movement step.

[0231] For some applications, the method includes covering an excess portion of the contraction member by coupling a contraction member covering device to the contraction member near the distal tissue anchor.

[0232] For some applications, covering the excess portion of the contraction member includes covering a free end of the contraction member.

[0233] For some applications, the constriction member covering device includes a fastener, and restricting movement of the constriction member includes restricting movement by coupling the fastener to the constriction member. The above methods can be performed on a live animal or a simulation such as a cadaver, a cadaver heart, a simulator (e.g., a body part, heart, tissue, etc., simulated), etc.

[0234] Further, according to an application, a tissue anchor usable with or for use with an anchor driver is provided. The anchor includes a tissue engaging element. In some applications, the tissue engaging element is helical, defines a central longitudinal axis of the anchor, has a rod with a sharpened distal tip, and can be configured to be inserted into tissue of a subject. The anchor also includes a head coupled to a proximal end of the tissue engaging element. The head can include a driver interface configured to be reversibly engaged by the anchor driver and an eyelet or other connector (e.g., connectable to a wire, line, contraction member, tether, suture, etc.). The eyelet can form an aperture through which a wire can be passed. The rod has a height across a first cross-sectional axis and a width across a second cross-sectional axis orthogonal to the first cross-sectional axis, the width of the rod being greater than its height.

[0235] For some applications, the rod has an elliptical cross-sectional profile. For one application, the rod width is 1.3 to 5 times its height. For one application, the rod width is 1.4 to 3 times its height. For one application, the rod width is 1.5 to 2.5 times its height. For one application, the rod width is 1.5 to 2.1 times its height. For one application, the rod width is 1.6 to 2 times its height. For one application, the first cross-sectional axis is parallel to the central longitudinal axis. For some applications, the first cross-sectional axis is angled with respect to the central longitudinal axis.

[0236] Further, according to the application, a system and / or device including a tissue anchor usable with or for use with an anchor driver is provided. The anchor includes a tissue engaging element. In some applications, the tissue engaging element may be helical, define a central longitudinal axis of the anchor having a sharpened distal tip, and be configured to be driven into the tissue of a subject. Other tissue engaging element configurations are possible. The anchor also includes a head coupled to a proximal end of the tissue engaging element. The head may include a driver interface configured for reversible engagement by the anchor driver and a ring including a channel. The channel defines a channel axis perpendicular to an axis parallel to the central longitudinal axis. The ring surrounds the central longitudinal axis and is rotatable about the central longitudinal axis. The channel axis is offset from the central longitudinal axis, forming a gap between the innermost edge of the channel and the central longitudinal axis.

[0237] For some applications, the head includes a driver interface and further includes a proximal head segment disposed proximal to the ring, the proximal head segment being immovable relative to the tissue engaging element.

[0238] For some applications, the head further includes a distal head segment disposed distally of the ring, the distal head segment being immovable relative to the tissue engaging element.

[0239] For some applications, the tissue anchor is a first tissue anchor of a plurality of tissue anchors, and the system and / or device further includes an annuloplasty implant including the plurality of tissue anchors and a wire extending through a channel in the plurality of tissue anchors. In one application, a diameter of the channel is no greater than 5 percent of a thickness of the wire.

[0240] Further, according to the application, a system and / or device including a tissue anchor usable with or for use with the anchor driver is provided. The anchor includes a tissue engaging element. The tissue engaging element may be helical, define a central longitudinal axis of the anchor, have a sharpened distal tip, and be configured to be driven into the subject's tissue. Other tissue engaging element configurations are possible. The anchor also includes a head coupled to a proximal end of the tissue engaging element. The head may include a driver interface configured for reversible engagement by the anchor driver and a stem having a stem outer diameter, the stem being coaxial with the central longitudinal axis. The head also includes a ring forming a ring inner diameter. The ring is disposed around the stem and is rotatable about the central longitudinal axis and movable laterally relative to the stem.

[0241] In one application, the inner diameter of the ring is at least 1.3 times the outer diameter of the stem. In one application, the inner diameter of the ring is 1.3 to 5 times the outer diameter of the stem. In one application, the inner diameter of the ring is 1.4 to 3 times the outer diameter of the stem. In one application, the inner diameter of the ring is 1.5 to 2.5 times the outer diameter of the stem. In one application, the inner diameter of the ring is 1.5 to 2.1 times the outer diameter of the stem. In one application, the inner diameter of the ring is 1.6 to 2 times the outer diameter of the stem.

[0242] For some applications, the head includes a driver interface and further includes a proximal head segment disposed proximal to the ring and a distal head segment disposed distal to the ring, wherein the proximal head segment and the distal head segment are immovable relative to the tissue engaging element.

[0243] For some applications, the proximal head segment includes a proximal groove and the distal head segment includes a distal groove, the proximal and distal grooves being aligned with one another and parallel to the central longitudinal axis.

[0244] For some applications, the tissue anchor is a first tissue anchor of a plurality of tissue anchors, and the system and / or device further includes an annuloplasty implant including the plurality of tissue anchors and a wire threaded through a ring of the plurality of tissue anchors.

[0245] For some applications, the proximal and distal grooves are configured to accommodate at least a portion of a wire.

[0246] For some applications, the head has an outer diameter that is larger than the outer diameter of the tissue engaging element, hi some applications, the difference between the outer diameter of the head and the outer diameter of the tissue engaging element is at least twice the thickness of the wire.

[0247] For some applications, the system and / or apparatus further includes a delivery tube comprising a flexible tube defining an inner tube diameter, the inner tube diameter being no more than 20 percent larger than the outer diameter of the ring. In one application, the inner tube diameter is no more than 10 percent larger than the outer diameter of the ring. In one application, the inner tube diameter is no more than 5 percent larger than the outer diameter of the ring.

[0248] Further, according to the application, a system and / or device including a tissue anchor usable with or for use with the anchor driver is provided. The anchor includes a tissue engaging element. The tissue engaging element can be configured in various ways. For example, the tissue engaging element can define a central longitudinal axis of the anchor with a sharpened distal tip and be configured to be driven into tissue of a subject. The anchor also includes a head coupled to a proximal end of the tissue engaging element. The head includes a wire tensioning mechanism for applying tension to the wire. The wire tensioning mechanism can include a housing and a spool.

[0249] The housing includes a housing base portion, a housing top portion forming an upper opening, a sidewall extending between the housing base portion and the housing top portion, and an inner chamber formed between the housing base portion and the sidewall. The housing top portion includes a complementary locking interface. The sidewall includes at least one side opening. The inner chamber has an inner chamber diameter.

[0250] A spool having a spool diameter is disposed within the internal chamber. The spool includes a spool base opposite the housing base portion, a spool top portion opposite the housing top portion, a spool central lumen coaxial with the central longitudinal axis, and a channel defining a channel axis perpendicular to an axis parallel to the central longitudinal axis. The spool top portion includes a spool locking interface configured to releasably engage a complementary locking interface and a spool driving interface opposite the top opening. The channel axis is offset from the spool central lumen.

[0251] The wire tensioning mechanism also includes a spring disposed between the housing and the spool. The housing may include a driver interface configured to be reversibly engaged by an anchor driver, and a stem extending through the spool central lumen between the tissue engaging element and the driver interface.

[0252] The wire tensioning mechanism is configured to transition between a locked configuration in which the spool locking interface engages a complementary locking interface, thereby preventing the spool from rotating relative to the housing, and an unlocked configuration in which the spool locking interface disengages from the complementary locking interface, thereby allowing the spool to rotate relative to the housing. The spring is configured, in its free state, to bias the spool into engagement with the housing to form the locked configuration of the wire tensioning mechanism.

[0253] For some applications, the spring is disposed between the housing base portion and the spool base. For some applications, the housing base portion includes a base groove, and the spring is disposed within the base groove. For one application, the spring is a disc spring.

[0254] For some applications, the housing top further includes a housing top interface.

[0255] In some applications, the system and / or device further includes a wire, the wire extending through the channel through at least one side opening. In one application, the difference between the inner chamber diameter and the spool diameter is at least 200% greater than the diameter of the wire. In one application, the difference between the inner chamber diameter and the spool diameter is at least 250% greater than the diameter of the wire. In one application, the difference between the inner chamber diameter and the spool diameter is at least 300% greater than the diameter of the wire. In one application, the difference between the inner chamber diameter and the spool diameter is at least 400% greater than the diameter of the wire. In one application, the diameter of the channel is no more than 5% greater than the outer diameter of the ring.

[0256] For some applications, the system and / or device further includes a stopper attached to the end of the wire and disposed between the channel and the sidewall, the stopper having a diameter larger than a diameter of the channel. For some applications, the wire is attached to the spool via a closed loop that extends through the channel and around a portion of the spool.

[0257] For some applications, the spool further includes a spool side recess, and the stem further includes a protrusion configured to engage with the spool side recess in the locked configuration, thereby preventing rotational movement of the tissue engaging element relative to the spool, and to disengage therefrom in the unlocked configuration, thereby allowing the tissue engaging element to rotate relative to the spool.

[0258] For some applications, the housing is rotatable about a central longitudinal axis relative to the tissue engaging element.

[0259] For some applications, the anchor further includes a flange disposed about the proximal end of the tissue engaging element and configured to support the housing.

[0260] For some applications, the at least one side opening includes two side openings opposite one another.

[0261] For some applications, the tissue anchor is one of a plurality of tissue anchors. For some applications, the tissue anchor is a primary tissue anchor, and the device further includes at least one secondary tissue anchor for use with the anchor driver. The secondary tissue anchor may be similar to the primary tissue anchor in that the secondary tissue anchor also includes a tissue engaging element, which may be referred to as a secondary tissue engaging element. The secondary tissue engaging element may also have a secondary sharpened distal tip and may also be configured to be driven into the subject's tissue. Similarly, the secondary anchor also includes a secondary head coupled to a proximal end of the secondary tissue engaging element, and the head may include a driver interface configured to be reversibly engaged by the anchor driver. However, the secondary tissue anchor may differ from the primary anchor in that the secondary anchor lacks a wire tensioning mechanism including a spool.

[0262] For some applications, the system also includes an adjustment tool having an adjustment interface. The adjustment interface is configured to interface with the spool driving interface. The adjustment tool is configured to push the spool against the spring to transition the wire tensioning mechanism to the unlocked configuration and to rotate the spool about the central longitudinal axis of the unlocked configuration. For some applications, the system also includes a holding tool having a retention interface. The retention interface is configured to engage with the housing top interface.

[0263] Further, according to an application, there is provided a system and / or apparatus including a wire take-up assembly. The wire take-up assembly includes a sleeve defining a central longitudinal axis and a gripper at least partially disposed within the sleeve. The sleeve includes a sleeve lumen having a lumen diameter. The gripper includes a gripper distal portion having a gripper distal diameter and a gripper narrow portion having a narrow diameter. The gripper is axially movable relative to the sleeve. The gripper distal diameter is smaller than the lumen diameter. The narrow diameter is smaller than the gripper distal diameter.

[0264] For some applications, the gripper distal portion includes a rounded gripper distal end.For some applications, the gripper distal portion includes a tapered gripper distal end.

[0265] For some applications, the gripper distal portion and the gripper narrow portion are symmetrically disposed about the central longitudinal axis. For some applications, the gripper distal portion and the gripper neck portion are asymmetrically disposed about the central longitudinal axis.

[0266] For some applications, the system and / or device further includes a wire having a free-state wire diameter. In one application, the wire is compressible to at least 95% of its free-state wire diameter. In one application, the wire is compressible to at least 90% of its free-state wire diameter. In one application, the wire is compressible to at least 80% of its free-state wire diameter. In one application, the wire is compressible to at least 60% of its free-state wire diameter.

[0267] In one application, the difference between the lumen diameter and the gripper distal diameter is less than the wire diameter. In one application, the difference between the lumen diameter and the gripper distal diameter is less than 90% of the wire diameter. In one application, the difference between the lumen diameter and the gripper distal diameter is less than 70% of the wire diameter. In one application, the difference between the lumen diameter and the gripper distal diameter is less than 30% of the wire diameter. In one application, the difference between the lumen diameter and the gripper distal diameter is less than 10% of the wire diameter.

[0268] In one application, the difference between the lumen diameter and the narrow diameter is at least as large as the wire diameter. In one application, the difference between the lumen diameter and the narrow diameter is greater than 110% of the wire diameter. In one application, the difference between the lumen diameter and the narrow diameter is greater than 120% of the wire diameter. In one application, the difference between the lumen diameter and the narrow diameter is greater than 130% of the wire diameter. In one application, the difference between the lumen diameter and the narrow diameter is greater than 150% of the wire diameter. In one application, the difference between the lumen diameter and the narrow diameter is greater than 200% of the wire diameter.

[0269] For some applications, the gripper further includes a gripper proximal portion having a gripper proximal diameter, the lumen diameter being at least as large as the gripper proximal diameter, and the gripper distal diameter being smaller than the gripper proximal diameter.

[0270] In one application, the difference between the lumen diameter and the gripper proximal diameter is less than the wire diameter. In one application, the difference between the lumen diameter and the gripper proximal diameter is not greater than 95% of the wire diameter. In one application, the difference between the lumen diameter and the gripper proximal diameter is not greater than 90% of the wire diameter. In one application, the difference between the lumen diameter and the gripper proximal diameter is not greater than 85% of the wire diameter. In one application, the difference between the lumen diameter and the gripper proximal diameter is not greater than 80% of the wire diameter.

[0271] For some applications, the system and / or device further includes a catheter forming a catheter lumen, the wire uptake assembly being at least partially disposed within the catheter lumen, and at least one component of the wire uptake assembly being axially movable relative to the catheter.

[0272] According to a further application, there is provided a method including inserting a wire into a sleeve lumen of a sleeve of a wire take-up assembly, the wire take-up assembly including a sleeve having a sleeve distal end and a gripper, the gripper including a gripper distal portion disposed distally of the sleeve distal end and a gripper narrow portion partially disposed within the sleeve lumen and partially exposed from the sleeve.

[0273] For some applications, the method further includes pulling the gripper until the gripper distal portion extends at least partially into the sleeve lumen and compresses the wire between the gripper distal portion and the sleeve so as to restrict axial movement of the wire relative to the sleeve. For some applications, the method further includes pulling the wire take-up assembly, thereby pulling the wire attached thereto.

[0274] For some applications, the step of inserting the wire into the sleeve lumen is performed such that the wire is inserted until further advancement is prevented by a gripper proximal portion of a gripper disposed within the sleeve lumen, the gripper proximal portion having a gripper proximal diameter such that the difference between the diameter of the sleeve lumen and the gripper proximal diameter is less than the wire diameter.

[0275] For some applications, the method further includes pushing the gripper distally until the wire is released from the wire capture assembly.

[0276] Further, according to an application, there is provided a method including implanting into a patient's cardiac annulus a docking device including an implant, the implant including: (1) a plurality of tissue anchors; and (2) a contraction member (e.g., a wire, line, suture, etc.) slidably coupled to the plurality of tissue anchors.

[0277] The method further includes contracting the implant to reduce the size of the heart valve annulus. The method further includes delivering the heart valve prosthesis in its crimped state. The method further includes expanding the prosthesis against the annulus under pressure to anchor the prosthesis to the annulus against the docking device.

[0278] For some applications, each one of the plurality of anchors includes a tissue engaging element having a sharpened distal tip, and implanting the plurality of anchors includes sequentially placing the anchors into tissue of the annulus.

[0279] For some applications, each one of the plurality of anchors includes a head including a driving interface. For some applications, driving each anchor into tissue of the annulus includes engaging an anchor driver with the driving interface and rotating the anchor driver to rotate the anchor about a central longitudinal axis defined by its tissue-engaging element. For some applications, the heads of at least two of the anchors include eyelets, and the contraction member is threaded through the eyelets.

[0280] In one application, the heart valve is a mitral valve. In one application, the heart valve is a tricuspid valve.

[0281] Further, according to the application, a system and / or device is provided that includes a plurality of tissue anchors and a wire assembly that can be used with or for use with an anchor driver. Each anchor includes a tissue-engaging element. The tissue-engaging element can be configured in various ways, for example, to define a central longitudinal axis of the anchor, have a sharpened distal tip, and be capable of being inserted into the subject's tissue. The anchor also includes a head coupled to a proximal end of the tissue-engaging element. The head can include a driver interface configured for reversible engagement by the anchor driver. The wire assembly extends through openings formed in the heads of the plurality of anchors. The wire assembly includes a main wire that includes a plurality of alternating portions coated with a radiopaque coating and a plurality of alternating radiolucent portions.

[0282] For some applications, the opening in the head of the anchor is an eyelet.For some applications, the opening in the head of the anchor is a channel.

[0283] For some applications, the main wire is formed from a metallic material selected from titanium, nitinol, platinum, stainless steel, and / or alloys and / or combinations thereof.

[0284] For some applications, the radiopaque coating comprises at least one biocompatible metallic material selected from gold, platinum, titanium, silver, tantalum, barium, bismuth, iridium, tungsten, rhenium, osmium, palladium, and biocompatible oxides and / or combinations thereof.

[0285] Further, according to the application, a system and / or device is provided that includes a plurality of tissue anchors and a wire assembly that can be used with or for use with an anchor driver. Each anchor includes a tissue-engaging element. The tissue-engaging element can be configured in various ways, for example, to define a central longitudinal axis of the anchor, have a sharpened distal tip, and be capable of being inserted into the subject's tissue. The anchor also includes a head coupled to a proximal end of the tissue-engaging element. The head can include a driver interface configured for reversible engagement by the anchor driver. The wire assembly extends through openings formed in the heads of the plurality of anchors. The wire assembly includes a main wire and a plurality of additional wires woven around the main wire. At least a portion of the main wire is coated with a radiopaque coating.

[0286] For some applications, the opening in the head of the anchor is an eyelet.For some applications, the opening in the head of the anchor is a channel.

[0287] For some applications, the main wire includes a plurality of alternating portions coated with a radiopaque coating and a plurality of alternating portions that are radiolucent, hi some applications, the plurality of additional wires are radiolucent.

[0288] For some applications, the main wire and each of the plurality of additional wires are formed of a metallic material selected from titanium, nitinol, platinum, stainless steel, and / or alloys and / or combinations thereof.

[0289] For some applications, the plurality of additional wires includes at least six additional wires woven around the main wire. For some applications, each one of the plurality of additional wires includes an inner wire assembly, each inner wire assembly including a plurality of inner wires. For some applications, each of the plurality of inner wires includes at least seven inner wires.

[0290] For some applications, each inner wire is formed from a metallic material selected from titanium, nitinol, stainless steel, and / or combinations thereof.

[0291] For some applications, the main wire includes a central inner wire assembly including a plurality of central inner wires. For some applications, at least a portion of the central inner wire assembly is coated with a radiopaque coating along its outer diameter. For some applications, the plurality of central inner wires includes at least seven central inner wires.

[0292] Further, according to the application, a system and / or device is provided that includes a plurality of tissue anchors and a wire assembly that can be used with or for use with an anchor driver. Each anchor includes a tissue-engaging element. The tissue-engaging element can be configured in various ways, for example, to define a central longitudinal axis of the anchor, have a sharpened distal tip, and be capable of being inserted into the subject's tissue. The anchor also includes a head coupled to a proximal end of the tissue-engaging element. The head can include a driver interface configured for reversible engagement by the anchor driver. The wire assembly extends through openings formed in the heads of the plurality of anchors. The wire assembly includes a main wire, at least one additional wire, and at least one composite tube including at least one radiopaque material, with the at least one additional wire and the at least one composite tube woven around the main wire.

[0293] For some applications, the opening in the head of the anchor is an eyelet.For some applications, the opening in the head of the anchor is a channel.

[0294] For some applications, the at least one composite tube comprises an inner core comprising at least one first material and an outer sheath comprising at least one layer comprising at least one second material, the inner core being disposed within the lumen of the outer sheath.

[0295] For some applications, the first material is selected from gold, platinum, titanium, silver, tantalum, palladium, nitinol, and / or combinations and / or alloys thereof. For some applications, the first material is radiopaque and the second material is radiolucent.

[0296] For some applications, each one of the main wires and the at least one additional wire is radiolucent and formed of a metallic material selected from titanium, nitinol, platinum, stainless steel, and / or alloys and / or combinations thereof.

[0297] For some applications, the at least one additional wire includes at least five additional wires, and the at least five additional wires and the at least one composite tube are woven around the main wire. For some applications, the at least one additional wire includes at least four additional wires, and the at least one composite tube includes at least two composite tubes, and the at least four additional wires and the at least two composite tubes are woven around the main wire.

[0298] Further, according to the application, a system and / or device including a plurality of tissue anchors and a wire assembly usable with or for use with an anchor driver is provided. Each anchor includes a tissue-engaging element. The tissue-engaging element may be configured in various ways, for example, to define a central longitudinal axis of the anchor, have a sharpened distal tip, and be capable of being inserted into the subject's tissue. The anchor also includes a head coupled to a proximal end of the tissue-engaging element. The head may include a driver interface configured for reversible engagement by the anchor driver. The wire assembly extends through openings formed in the heads of the plurality of anchors. The wire assembly includes a main wire, at least one additional wire, and at least one composite tube including at least one radiopaque material, wherein the at least one additional wire, the at least one composite tube, and the main wire are woven or interwoven with one another.

[0299] For some applications, the opening in the head of the anchor is an eyelet.For some applications, the opening in the head of the anchor is a channel.

[0300] For some applications, the at least one composite tube comprises an inner core comprising at least one first material and an outer sheath comprising at least one layer comprising at least one second material, the inner core being disposed within the lumen of the outer sheath.

[0301] For some applications, the first material is selected from gold, platinum, titanium, silver, tantalum, palladium, nitinol, and / or combinations and / or alloys thereof. For some applications, the first material is radiopaque and the second material is radiolucent.

[0302] For some applications, each one of the main wires and the at least one additional wire is radiolucent and formed of a metallic material selected from titanium, nitinol, platinum, stainless steel, and / or alloys and / or combinations thereof.

[0303] For some applications, the at least one additional wire includes at least five additional wires and at least one composite tube. For some applications, the at least one additional wire includes at least four additional wires, and the at least one composite tube includes at least two composite tubes and at least four additional wires.

[0304] According to some applications, a system and / or device is further provided that can be used with or is intended for use with an anchor driver, the system and / or device including an annulus-forming structure including a wire, a plurality of anchors, and a plurality of flexible sleeves. Various anchor configurations are possible. Each of the anchors includes a tissue-engaging element. For some applications, the tissue-engaging element defines a central longitudinal axis of the anchor having a sharpened distal tip and is configured to be inserted into tissue of a subject and a head. The head can be coupled to the tissue-engaging element via a neck. The head can include a driver interface configured to be reversibly engaged by the anchor driver. The head also defines a circumferential head surface about the central longitudinal axis.

[0305] Each of the plurality of flexible sleeves slidably couples a respective anchor of the plurality of anchors to a wire, line, contraction member, or the like. For some applications, each of the plurality of flexible sleeves includes a sleeve circumferential portion, a proximal opening sized to expose the driver interface, and a distal opening through which the neck extends. The sleeve circumferential portion is closely disposed around the head circumferential surface. The anchor is rotatable about the central longitudinal axis relative to the sleeve. Each flexible sleeve also includes at least one eyelet through which a wire is threaded, thereby slidably coupling the connector to the wire. For some applications, the flexible sleeve includes a fabric.

[0306] For some applications, the eyelets are formed by a patch joined to the sleeve at upper and lower portions of the patch.

[0307] For some applications, the wire is a first wire, the annulus-forming structure includes a second wire, and each one of the sleeves slidably couples a respective one of the anchors to the first wire and the second wire. For some applications, the first wire and the second wire are generally parallel to one another.

[0308] In one application, for each sleeve, the eyelet is a first eyelet, a first wire is threaded through the first eyelet, thereby slidably coupling the sleeve to the first wire, and the sleeve includes a second eyelet through which a second wire is threaded, thereby slidably coupling the sleeve to the second wire.

[0309] The present invention will be more fully understood from the following detailed description of its application, taken in conjunction with the drawings. [Brief explanation of the drawings]

[0310] [Figure 1A] 1A-1C are schematic diagrams of example tissue anchors, implants including the anchors, systems including the implants, and techniques for use therewith, according to some application examples. [Figure 1B] 1A-1C are schematic diagrams of example tissue anchors, implants including the anchors, systems including the implants, and techniques for use therewith, according to some application examples. [Figure 1C] 1A-1C are schematic diagrams of example tissue anchors, implants including the anchors, systems including the implants, and techniques for use therewith, according to some application examples. [Figure 2A] 1A-1C are schematic diagrams of example tissue anchors, implants including the anchors, systems including the implants, and techniques for use therewith, according to some application examples. [Figure 2B] 1A-1C are schematic diagrams of example tissue anchors, implants including the anchors, systems including the implants, and techniques for use therewith, according to some application examples. [Figure 3A] 1A-1C are schematic diagrams of example tissue anchors, implants including the anchors, systems including the implants, and techniques for use therewith, according to some application examples. [Figure 3B] 1A-1C are schematic diagrams of example tissue anchors, implants including the anchors, systems including the implants, and techniques for use therewith, according to some application examples. [Figure 4A] 1A-1C are schematic diagrams of example tissue anchors, implants including tissue anchors, systems including the implants, and techniques for use therewith, according to some application examples. [Figure 4B] 1A-1C are schematic diagrams of example tissue anchors, implants including tissue anchors, systems including the implants, and techniques for use therewith, according to some application examples. [Figure 4C] 1A-1C are schematic diagrams of example tissue anchors, implants including tissue anchors, systems including the implants, and techniques for use therewith, according to some application examples. [Figure 4D]1A-1C are schematic diagrams of example tissue anchors, implants including tissue anchors, systems including the implants, and techniques for use therewith, according to some application examples. [Figure 4E] 1A-1C are schematic diagrams of example tissue anchors, implants including tissue anchors, systems including the implants, and techniques for use therewith, according to some application examples. [Figure 4F] 1A-1C are schematic diagrams of example tissue anchors, implants including tissue anchors, systems including the implants, and techniques for use therewith, according to some application examples. [Figure 4G] 1A-1C are schematic diagrams of example tissue anchors, implants including tissue anchors, systems including the implants, and techniques for use therewith, according to some application examples. [Figure 4H] 1A-1C are schematic diagrams of example tissue anchors, implants including tissue anchors, systems including the implants, and techniques for use therewith, according to some application examples. [Figure 5A] 1A-1C are schematic diagrams of example tissue anchors, implants including tissue anchors, systems including the implants, and techniques for use therewith, according to some application examples. [Figure 5B] 1A-1C are schematic diagrams of example tissue anchors, implants including tissue anchors, systems including the implants, and techniques for use therewith, according to some application examples. [Figure 5C] 1A-1C are schematic diagrams of example tissue anchors, implants including tissue anchors, systems including the implants, and techniques for use therewith, according to some application examples. [Figure 6A] 1A-1C are schematic diagrams of example tissue anchors and techniques configured for use therewith to facilitate determination of successful fixation to tissue not within line of sight, according to some application examples. [Figure 6B]1A-1C are schematic diagrams of example tissue anchors and techniques configured for use therewith to facilitate determination of successful fixation to tissue not within line of sight, according to some application examples. [Figure 6C] 1A-1C are schematic diagrams of example tissue anchors and techniques configured for use therewith to facilitate determination of successful fixation to tissue not within line of sight, according to some application examples. [Figure 6D] 1A-1C are schematic diagrams of example tissue anchors and techniques configured for use therewith to facilitate determination of successful fixation to tissue not within line of sight, according to some application examples. [Figure 6E] 1A-1C are schematic diagrams of example tissue anchors and techniques configured for use therewith to facilitate determination of successful fixation to tissue not within line of sight, according to some application examples. [Figure 7A] 1A-1C are schematic diagrams of example tissue anchors and techniques configured for use therewith to facilitate determination of successful fixation to tissue not within line of sight, according to some application examples. [Figure 7B] 1A-1C are schematic diagrams of example tissue anchors and techniques configured for use therewith to facilitate determination of successful fixation to tissue not within line of sight, according to some application examples. [Figure 7C] 1A-1C are schematic diagrams of example tissue anchors and techniques configured for use therewith to facilitate determination of successful fixation to tissue not within line of sight, according to some application examples. [Figure 7D] 1A-1C are schematic diagrams of example tissue anchors and techniques configured for use therewith to facilitate determination of successful fixation to tissue not within line of sight, according to some application examples. [Figure 7E] 1A-1C are schematic diagrams of example tissue anchors and techniques configured for use therewith to facilitate determination of successful fixation to tissue not within line of sight, according to some application examples. [Figure 8A]1A-1C are schematic diagrams of example tissue anchors and techniques configured for use therewith to facilitate determination of successful fixation to tissue not within line of sight, according to some application examples. [Figure 8B] 1A-1C are schematic diagrams of example tissue anchors and techniques configured for use therewith to facilitate determination of successful fixation to tissue not within line of sight, according to some application examples. [Figure 8C] 1A-1C are schematic diagrams of example tissue anchors and techniques configured for use therewith to facilitate determination of successful fixation to tissue not within line of sight, according to some application examples. [Figure 8D] 1A-1C are schematic diagrams of example tissue anchors and techniques configured for use therewith to facilitate determination of successful fixation to tissue not within line of sight, according to some application examples. [Figure 8E] 1A-1C are schematic diagrams of example tissue anchors and techniques configured for use therewith to facilitate determination of successful fixation to tissue not within line of sight, according to some application examples. [Figure 9A] 1A-1C are schematic diagrams of example tissue anchors and techniques configured for use therewith to facilitate determination of successful fixation to tissue not within line of sight, according to some application examples. [Figure 9B] 1A-1C are schematic diagrams of example tissue anchors and techniques configured for use therewith to facilitate determination of successful fixation to tissue not within line of sight, according to some application examples. [Figure 9C] 1A-1C are schematic diagrams of example tissue anchors and techniques configured for use therewith to facilitate determination of successful fixation to tissue not within line of sight, according to some application examples. [Figure 9D] 1A-1C are schematic diagrams of example tissue anchors and techniques configured for use therewith to facilitate determination of successful fixation to tissue not within line of sight, according to some application examples. [Figure 9E]1A-1C are schematic diagrams of example tissue anchors and techniques configured for use therewith to facilitate determination of successful fixation to tissue not within line of sight, according to some application examples. [Figure 10A] 1A-1C are schematic diagrams of example tissue anchors and techniques configured for use therewith to facilitate determination of successful fixation to tissue not within line of sight, according to some application examples. [Figure 10B] 1A-1C are schematic diagrams of example tissue anchors and techniques configured for use therewith to facilitate determination of successful fixation to tissue not within line of sight, according to some application examples. [Figure 10C] 1A-1C are schematic diagrams of example tissue anchors and techniques configured for use therewith to facilitate determination of successful fixation to tissue not within line of sight, according to some application examples. [Figure 10D] 1A-1C are schematic diagrams of example tissue anchors and techniques configured for use therewith to facilitate determination of successful fixation to tissue not within line of sight, according to some application examples. [Figure 10E] 1A-1C are schematic diagrams of example tissue anchors and techniques configured for use therewith to facilitate determination of successful fixation to tissue not within line of sight, according to some application examples. [Figure 11A] 1A-1C are schematic diagrams of example tissue anchors and techniques configured for use therewith to facilitate determination of successful fixation to tissue not within line of sight, according to some application examples. [Figure 11B] 1A-1C are schematic diagrams of example tissue anchors and techniques configured for use therewith to facilitate determination of successful fixation to tissue not within line of sight, according to some application examples. [Figure 12A] 1A-1C are schematic diagrams of example tissue anchors and techniques configured for use therewith to facilitate determination of successful fixation to tissue not within line of sight, according to some application examples. [Figure 12B]1A-1C are schematic diagrams of example tissue anchors and techniques configured for use therewith to facilitate determination of successful fixation to tissue not within line of sight, according to some application examples. [Figure 13A] 1A-1C are schematic diagrams of example tissue anchors and techniques configured for use therewith to facilitate determination of successful fixation to tissue not within line of sight, according to some application examples. [Figure 13B] 1A-1C are schematic diagrams of example tissue anchors and techniques configured for use therewith to facilitate determination of successful fixation to tissue not within line of sight, according to some application examples. [Figure 14A] 1A-1C are schematic diagrams of example tissue anchors and techniques configured for use therewith to facilitate determination of successful fixation to tissue not within line of sight, according to some application examples. [Figure 14B] 1A-1C are schematic diagrams of example tissue anchors and techniques configured for use therewith to facilitate determination of successful fixation to tissue not within line of sight, according to some application examples. [Figure 15] 1A-1C are schematic diagrams of exemplary tissue anchors, according to some applications. [Figure 16A] 1 is a schematic diagram of an exemplary system for facilitating controlled fixation of anchors to tissue, according to some applications. [Figure 16B] 1 is a schematic diagram of an exemplary system for facilitating controlled fixation of anchors to tissue, according to some applications. [Figure 16C] 1 is a schematic diagram of an exemplary system for facilitating controlled fixation of anchors to tissue, according to some applications. [Figure 17A] 1 is a schematic diagram of an exemplary system for facilitating controlled fixation of anchors to tissue, according to some applications. [Figure 17B] 1 is a schematic diagram of an exemplary system for facilitating controlled fixation of anchors to tissue, according to some applications. [Figure 17C]1 is a schematic diagram of an exemplary system for facilitating controlled fixation of anchors to tissue, according to some applications. [Figure 18] 1 is a schematic diagram of an exemplary system for facilitating controlled fixation of anchors to tissue, according to some applications. [Figure 19A] 1 is a schematic diagram of an exemplary system for facilitating controlled fixation of anchors to tissue, according to some applications. [Figure 19B] 1 is a schematic diagram of an exemplary system for facilitating controlled fixation of anchors to tissue, according to some applications. [Figure 19C] 1 is a schematic diagram of an exemplary system for facilitating controlled fixation of anchors to tissue, according to some applications. [Figure 20A] 1 is a schematic diagram of an example system including an implant, according to some applications. [Figure 20B] 1 is a schematic diagram of an example system including an implant, according to some applications. [Figure 20C] 1 is a schematic diagram of an example system including an implant, according to some applications. [Figure 20D] 1 is a schematic diagram of an example system including an implant, according to some applications. [Figure 21A] 1A-1C are schematic diagrams of example tissue anchors, implants including tissue anchors, systems including the implants, and techniques for use therewith, according to some application examples. [Figure 21B] 1A-1C are schematic diagrams of example tissue anchors, implants including tissue anchors, systems including the implants, and techniques for use therewith, according to some application examples. [Figure 21C] 1A-1C are schematic diagrams of example tissue anchors, implants including tissue anchors, systems including the implants, and techniques for use therewith, according to some application examples. [Figure 21D]1A-1C are schematic diagrams of example tissue anchors, implants including tissue anchors, systems including the implants, and techniques for use therewith, according to some application examples. [Figure 21E] 1A-1C are schematic diagrams of example tissue anchors, implants including tissue anchors, systems including the implants, and techniques for use therewith, according to some application examples. [Figure 21F] 1A-1C are schematic diagrams of example tissue anchors, implants including tissue anchors, systems including the implants, and techniques for use therewith, according to some application examples. [Figure 21G] 1A-1C are schematic diagrams of example tissue anchors, implants including tissue anchors, systems including the implants, and techniques for use therewith, according to some application examples. [Figure 22A] 1A-1C are schematic diagrams of example tissue anchors, implants including tissue anchors, systems including the implants, and techniques for use therewith, according to some application examples. [Figure 22B] 1A-1C are schematic diagrams of example tissue anchors, implants including tissue anchors, systems including the implants, and techniques for use therewith, according to some application examples. [Figure 23A] 1A-1C are schematic diagrams of example tissue anchors, implants including tissue anchors, systems including the implants, and techniques for use therewith, according to some application examples. [Figure 23B] 1A-1C are schematic diagrams of example tissue anchors, implants including tissue anchors, systems including the implants, and techniques for use therewith, according to some application examples. [Figure 24] 1A-1C are schematic diagrams of example tissue anchors, implants including tissue anchors, systems including the implants, and techniques for use therewith, according to some application examples. [Figure 25]1A-1C are schematic diagrams of example tissue anchors, implants including tissue anchors, systems including the implants, and techniques for use therewith, according to some application examples. [Figure 26] 1A-1C are schematic diagrams of example tissue anchors, implants including tissue anchors, systems including the implants, and techniques for use therewith, according to some application examples. [Figure 27] 1A-1C are schematic diagrams of example tissue anchors, implants including tissue anchors, systems including the implants, and techniques for use therewith, according to some application examples. [Figure 28A] 1A-1C are schematic diagrams of example systems for facilitating determination of successful (e.g., complete) fixation to tissue not within the line of sight, according to some application examples. [Figure 28B] 1A-1C are schematic diagrams of example systems for facilitating determination of successful (e.g., complete) fixation to tissue not within the line of sight, according to some application examples. [Figure 29A] 1A-1C are schematic diagrams of example systems for facilitating determination of successful (e.g., complete) fixation to tissue not within the line of sight, according to some application examples. [Figure 29B] 1A-1C are schematic diagrams of example systems for facilitating determination of successful (e.g., complete) fixation to tissue not within the line of sight, according to some application examples. [Figure 30] 1A-1C are schematic diagrams of example systems for facilitating determination of successful (e.g., complete) fixation to tissue not within the line of sight, according to some application examples. [Figure 31A] 1A-1C are schematic diagrams of example systems for facilitating determination of successful (e.g., complete) fixation to tissue not within the line of sight, according to some application examples. [Figure 31B] 1A-1C are schematic diagrams of example systems for facilitating determination of successful (e.g., complete) fixation to tissue not within the line of sight, according to some application examples. [Figure 32]1A-1C are schematic diagrams of example systems for facilitating determination of successful (e.g., complete) fixation to tissue not within the line of sight, according to some application examples. [Figure 33] 1A-1C are schematic diagrams of example systems for facilitating determination of successful (e.g., complete) fixation to tissue not within the line of sight, according to some application examples. [Figure 34A] 1A-1C are schematic diagrams of example systems for facilitating determination of successful (e.g., complete) fixation to tissue not within the line of sight, according to some application examples. [Figure 34B] 1A-1C are schematic diagrams of example systems for facilitating determination of successful (e.g., complete) fixation to tissue not within the line of sight, according to some application examples. [Figure 35A] 10A-10C are schematic diagrams of example systems for covering excess contraction material after the contraction material has been cut after tightening, according to some applications. [Figure 35B] 10A-10C are schematic diagrams of example systems for covering excess contraction material after the contraction material has been cut after tightening, according to some applications. [Figure 36A] 10A-10C are schematic diagrams of example systems for covering excess contraction material after the contraction material has been cut after tightening, according to some applications. [Figure 36B] 10A-10C are schematic diagrams of example systems for covering excess contraction material after the contraction material has been cut after tightening, according to some applications. [Figure 37A] 10A-10C are schematic diagrams of example systems for covering excess contraction material after the contraction material has been cut after tightening, according to some applications. [Figure 37B] 10A-10C are schematic diagrams of example systems for covering excess contraction material after the contraction material has been cut after tightening, according to some applications. [Figure 38A] 10A-10C are schematic diagrams of example systems for covering excess contraction material after the contraction material has been cut after tightening, according to some applications. [Figure 38B] 10A-10C are schematic diagrams of example systems for covering excess contraction material after the contraction material has been cut after tightening, according to some applications. [Figure 39A] 10A-10C are schematic diagrams of example systems for covering excess contraction material after the contraction material has been cut after tightening, according to some applications. [Figure 39B] 10A-10C are schematic diagrams of example systems for covering excess contraction material after the contraction material has been cut after tightening, according to some applications. [Figure 40A] 10A-10C are schematic diagrams of example systems including respective locking mechanisms that include fasteners configured to be coupleable to a contraction member, according to some applications. [Figure 40B] 10A-10C are schematic diagrams of example systems including respective locking mechanisms that include fasteners configured to be coupleable to a contraction member, according to some applications. [Figure 41A] 10A-10C are schematic diagrams of example systems including respective locking mechanisms that include fasteners configured to be coupleable to a contraction member, according to some applications. [Figure 41B] 10A-10C are schematic diagrams of example systems including respective locking mechanisms that include fasteners configured to be coupleable to a contraction member, according to some applications. [Figure 42A] 10A-10C are schematic diagrams of example systems including respective locking mechanisms that include fasteners configured to be coupleable to a contraction member, according to some applications. [Figure 42B] 10A-10C are schematic diagrams of example systems including respective locking mechanisms that include fasteners configured to be coupleable to a contraction member, according to some applications. [Figure 43A] 10A-10C are schematic diagrams of example systems including respective locking mechanisms that include fasteners configured to be coupleable to a contraction member, according to some applications. [Figure 43B]10A-10C are schematic diagrams of example systems including respective locking mechanisms that include fasteners configured to be coupleable to a contraction member, according to some applications. [Figure 44A] 10A-10C are schematic diagrams of example systems for covering excess contraction material after the contraction material has been cut after tightening, according to some applications. [Figure 44B] 10A-10C are schematic diagrams of example systems for covering excess contraction material after the contraction material has been cut after tightening, according to some applications. [Figure 45A] 10A-10C are schematic diagrams of example systems for covering excess contraction material after the contraction material has been cut after tightening, according to some applications. [Figure 45B] 10A-10C are schematic diagrams of example systems for covering excess contraction material after the contraction material has been cut after tightening, according to some applications. [Figure 46A] 10A-10C are schematic diagrams of example systems for covering excess contraction material after the contraction material has been cut after tightening, according to some applications. [Figure 46B] 10A-10C are schematic diagrams of example systems for covering excess contraction material after the contraction material has been cut after tightening, according to some applications. [Figure 47A] 1A-1C are schematic diagrams of embodiments of tissue anchors, according to some applications. [Figure 47B] 1A-1C are schematic diagrams of embodiments of tissue anchors, according to some applications. [Figure 48] 1A-1C are schematic diagrams of exemplary tissue anchors and implants including tissue anchors, according to some applications. [Figure 49] 1A-1C are schematic diagrams of exemplary tissue anchors and implants including tissue anchors, according to some applications. [Figure 50A] 1A-1C are schematic diagrams of exemplary tissue anchors, implants including tissue anchors, and systems including the implants, according to some applications. [Figure 50B]1A-1C are schematic diagrams of exemplary tissue anchors, implants including tissue anchors, and systems including the implants, according to some applications. [Figure 51] 1A-1C are schematic diagrams of exemplary tissue anchors, implants including tissue anchors, and systems including the implants, according to some applications. [Figure 52A] 1A-1C are schematic diagrams of example wire tensioning mechanisms, tissue anchors including wire tensioning mechanisms, implants including such tissue anchors, and techniques for use therewith, according to some application examples. [Figure 52B] 1A-1C are schematic diagrams of example wire tensioning mechanisms, tissue anchors including wire tensioning mechanisms, implants including such tissue anchors, and techniques for use therewith, according to some application examples. [Figure 52C] 1A-1C are schematic diagrams of example wire tensioning mechanisms, tissue anchors including wire tensioning mechanisms, implants including such tissue anchors, and techniques for use therewith, according to some application examples. [Figure 53A] 1A-1C are schematic diagrams of example wire tensioning mechanisms, tissue anchors including wire tensioning mechanisms, implants including such tissue anchors, and techniques for use therewith, according to some application examples. [Figure 53B] 1A-1C are schematic diagrams of example wire tensioning mechanisms, tissue anchors including wire tensioning mechanisms, implants including such tissue anchors, and techniques for use therewith, according to some application examples. [Figure 53C] 1A-1C are schematic diagrams of example wire tensioning mechanisms, tissue anchors including wire tensioning mechanisms, implants including such tissue anchors, and techniques for use therewith, according to some application examples. [Figure 54A] 1A-1C are schematic diagrams of example wire tensioning mechanisms, tissue anchors including wire tensioning mechanisms, implants including such tissue anchors, and techniques for use therewith, according to some application examples. [Figure 54B]1A-1C are schematic diagrams of example wire tensioning mechanisms, tissue anchors including wire tensioning mechanisms, implants including such tissue anchors, and techniques for use therewith, according to some application examples. [Figure 54C] 1A-1C are schematic diagrams of example wire tensioning mechanisms, tissue anchors including wire tensioning mechanisms, implants including such tissue anchors, and techniques for use therewith, according to some application examples. [Figure 54D] 1A-1C are schematic diagrams of example wire tensioning mechanisms, tissue anchors including wire tensioning mechanisms, implants including such tissue anchors, and techniques for use therewith, according to some application examples. [Figure 55] 1A-1C are schematic diagrams of wire capture assemblies, systems including wire capture assemblies, and techniques for use therewith, according to some applications. [Figure 56A] 1A-1C are schematic diagrams of wire capture assemblies, systems including wire capture assemblies, and techniques for use therewith, according to some applications. [Figure 56B] 1A-1C are schematic diagrams of wire capture assemblies, systems including wire capture assemblies, and techniques for use therewith, according to some applications. [Figure 56C] 1A-1C are schematic diagrams of wire capture assemblies, systems including wire capture assemblies, and techniques for use therewith, according to some applications. [Figure 57A] 1A-1C are schematic diagrams of wire capture assemblies, systems including wire capture assemblies, and techniques for use therewith, according to some applications. [Figure 57B] 1A-1C are schematic diagrams of wire capture assemblies, systems including wire capture assemblies, and techniques for use therewith, according to some applications. [Figure 57C]1A-1C are schematic diagrams of wire capture assemblies, systems including wire capture assemblies, and techniques for use therewith, according to some applications. [Figure 57D] 1A-1C are schematic diagrams of wire capture assemblies, systems including wire capture assemblies, and techniques for use therewith, according to some applications. [Figure 58A] 1A-1C are schematic diagrams of wire capture assemblies, systems including wire capture assemblies, and techniques for use therewith, according to some applications. [Figure 58B] 1A-1C are schematic diagrams of wire capture assemblies, systems including wire capture assemblies, and techniques for use therewith, according to some applications. [Figure 58C] 1A-1C are schematic diagrams of wire capture assemblies, systems including wire capture assemblies, and techniques for use therewith, according to some applications. [Figure 59A] 1A-1C are schematic diagrams of wire capture assemblies, systems including wire capture assemblies, and techniques for use therewith, according to some applications. [Figure 59B] 1A-1C are schematic diagrams of wire capture assemblies, systems including wire capture assemblies, and techniques for use therewith, according to some applications. [Figure 59C] 1A-1C are schematic diagrams of wire capture assemblies, systems including wire capture assemblies, and techniques for use therewith, according to some applications. [Figure 60] 1A-1C are schematic diagrams of a technique for using an implant to constrict the annulus of a native valve and subsequently implanting a prosthetic valve, according to some applications. [Figure 61] 1A-1C are schematic diagrams of a technique for using an implant to constrict the annulus of a native valve and subsequently implanting a prosthetic valve, according to some applications. [Figure 62A]1A-1C are schematic diagrams of a technique for using an implant to constrict the annulus of a native valve and subsequently implanting a prosthetic valve, according to some applications. [Figure 62B] 1A-1C are schematic diagrams of a technique for using an implant to constrict the annulus of a native valve and subsequently implanting a prosthetic valve, according to some applications. [Figure 62C] 1A-1C are schematic diagrams of a technique for using an implant to constrict the annulus of a native valve and subsequently implanting a prosthetic valve, according to some applications. [Figure 63] 1A-1C are schematic diagrams of example wire assemblies and implants including the wire assemblies, according to some applications. [Figure 64] 1A-1C are schematic diagrams of example wire assemblies and implants including the wire assemblies, according to some applications. [Figure 65A] 1A-1C are schematic diagrams of example wire assemblies and implants including the wire assemblies, according to some applications. [Figure 65B] 1A-1C are schematic diagrams of example wire assemblies and implants including the wire assemblies, according to some applications. [Figure 65C] 1A-1C are schematic diagrams of example wire assemblies and implants including the wire assemblies, according to some applications. [Figure 66A] 1A-1C are schematic diagrams of example wire assemblies and implants including the wire assemblies, according to some applications. [Figure 66B] 1A-1C are schematic diagrams of example wire assemblies and implants including the wire assemblies, according to some applications. [Figure 67A] 1A-1C are schematic diagrams of example wire assemblies and implants including the wire assemblies, according to some applications. [Figure 67B] 1A-1C are schematic diagrams of example wire assemblies and implants including the wire assemblies, according to some applications. [Figure 67C]1A-1C are schematic diagrams of example wire assemblies and implants including the wire assemblies, according to some applications. [Figure 68A] 1A-1C are schematic diagrams of example wire assemblies and implants including the wire assemblies, according to some applications. [Figure 68B] 1A-1C are schematic diagrams of example wire assemblies and implants including the wire assemblies, according to some applications. [Figure 68C] 1A-1C are schematic diagrams of example wire assemblies and implants including the wire assemblies, according to some applications. [Figure 69A] 1A-1C are schematic diagrams of example wire assemblies and implants including the wire assemblies, according to some applications. [Figure 69B] 1A-1C are schematic diagrams of example wire assemblies and implants including the wire assemblies, according to some applications. [Figure 70A] 1 is a schematic diagram of an example system including an implant, according to some applications. [Figure 70B] 1 is a schematic diagram of an example system including an implant, according to some applications. [Figure 70C] 1 is a schematic diagram of an example system including an implant, according to some applications. DETAILED DESCRIPTION OF THE INVENTION

[0311] In the following description, various aspects of the present disclosure are described. For purposes of explanation, specific configurations and details are set forth in order to provide a thorough understanding of different aspects of the present disclosure. However, it will be apparent to those skilled in the art that the disclosure may be practiced without the specific details presented herein. Furthermore, well-known features may be omitted or simplified in order not to obscure the present disclosure.

[0312] Throughout the drawing figures, different superscripts of the same reference number are used to indicate different embodiments of the same element. The disclosed device and system embodiments may include any combination of different embodiments of the same element. Specifically, any reference to an element without a superscript may refer to any alternative embodiment of the same element indicated by the superscript. To avoid undue confusion due to a plethora of reference numbers and leads in a particular drawing, some components may be introduced through more than one drawing and not explicitly identified in all subsequent drawings that include that component.

[0313] 1A-1C, 2A-2B, and 3A-3B, which are schematic illustrations of example tissue anchors 120, implants 110 including the anchors, systems 100 including the implants, and techniques for use therewith, according to several application examples. System 100 is a tissue adjustment system and can be used to adjust the dimensions of tissue structures. For example, system 100 can be an annuloplasty system and implant 110 can be an annuloplasty structure (e.g., an annuloplasty ring, an annuloplasty adjustment device, etc.).

[0314] Figure 1A shows an isometric view of an exemplary anchor 120, Figure 1B shows a side view of the anchor, and Figure 1C shows an end view of the anchor looking distally along the anchor's central longitudinal axis ax1. The anchor 120 includes a tissue-engaging element 130 and an eyelet 140. The tissue-engaging element 130 has a proximal end 132 and a distal end 134, which define the anchor's central longitudinal axis ax1. At the distal end 134, the tissue-engaging element 130 has a sharpened distal tip 138.

[0315] The tissue engaging element 130 is helical and defines a central lumen 136 along an axis ax1, the lumen having a transverse diameter d2 (i.e., d2 is the inner diameter of the helix formed by the tissue engaging element). The helix formed by the tissue engaging element 130 has an outer diameter d3. Other tissue engaging element configurations are possible.

[0316] The eyelet 140 is coupled to the proximal end 132 of the tissue engaging element 130. The eyelet 140 spans laterally across the proximal end of the tissue engaging element (e.g., across the proximal end of the lumen 136).

[0317] As described in more detail below, anchor 120 (e.g., its eyelet 140) is configured to facilitate sliding of the anchor along a wire (or sliding of a wire through the anchor) while the anchor is aligned with the wire, e.g., while axis ax1 is parallel to the wire. (In some applications, such alignment may mean that axis ax1 is coaxial with the wire.) In some applications, the lateral thickness d1 of eyelet 140 is sufficiently smaller than diameter d2 to allow the wire to pass through eyelet 140 and pass through lumen 136 in a straight line parallel to axis ax1. For example, lateral thickness d1 may be less than two-thirds the size (e.g., less than half the size, e.g., less than one-third the size) of diameter d2. In some applications, such sufficient space exists on either side of eyelet 140, but, as described and illustrated below, the wire often passes through the eyelet on one specific side. Often, as shown in FIG. 1C, eyelet 140 (or at least a proximal portion thereof) passes through axis ax1.

[0318] As described in more detail below, anchor 120 (e.g., its connector or eyelet 140) is configured to facilitate sliding of the anchor along a wire (or sliding of a wire through the anchor) while the anchor is oriented perpendicular to the wire (i.e., while axis ax1 is perpendicular to the wire). Eyelet 140 extends proximally, away from tissue engaging element 130, thereby forming bilaterally opposed apertures 146 proximal to the tissue engaging element. Eyelet 140 (or at least a proximal portion thereof) extends proximally enough to provide aperture 146 with a height along axis ax1 sufficient to allow a wire to pass smoothly through 146 in a straight line perpendicular to axis ax1.

[0319] For some applications, aperture 146 has a maximum width d4 (orthogonal to axis ax1) that is at least 90 percent greater than diameter d2. For some applications, connector or eyelet 140 does not extend laterally beyond the lateral extent of tissue engaging element 130 (e.g., the maximum outer width of eyelet 140 is less than diameter d3 of tissue engaging element 130), or at most extends laterally a distance of 10 percent or less of diameter d3 (e.g., the maximum outer width of eyelet 140 is 10 percent or less greater than diameter d3). The inventors hypothesize that these dimensions advantageously provide a large aperture 146 for transcatheter delivery without significantly increasing the overall width of anchor 120.

[0320] The system 100 includes an implant 110 including a wire 112 and at least one anchor 120. The system 100 further includes a delivery tool 150 for percutaneous (e.g., transluminal, e.g., transfemoral) implantation of the implant 110. The delivery tool 150 includes a flexible anchor driver 160 configured to reversibly engage with the eyelet 140. The driver 160 often includes an elongated, flexible shaft 162 and a driver head 164 coupled to the distal end of the shaft. The driver head 164 is the component of the anchor driver 160 that reversibly engages with the eyelet 140. Through this engagement, the driver 160 is configured to drive the tissue engaging element 130 into tissue, for example, by rotating (and pushing distally) the anchor 120. The delivery tool 150 may further include a flexible tube 152, through which the anchor 120 (engaged with the driver 160) is advanceable into tissue to which the anchor is to be secured.

[0321] For some applications, the width d4 and the height of the aperture are each at least 50 percent greater (e.g., two times greater) than the thickness of the wire 112. For some applications, the lateral distance (measured perpendicular to the axis ax1) between the eyelet 140 and the tissue engaging element 130 on the side 142 is at least 50 percent greater than the thickness of the wire 112.

[0322] The term "wire" (as used herein and in the claims) may refer to a single strand of metal, but also encompasses other elongated structures that can serve a similar function, such as lines, tethers, cables, threads, sutures, braids, contractile members, ribbons, etc. While "wires," "lines," etc. can be formed of metallic materials, this is not required, and "wires," "lines," etc. herein can be formed of one or more of a variety of different materials.

[0323] In the delivery state of system 100, anchor driver 160 is reversibly engaged with eyelet 140, and wire 112 extends longitudinally through lumen 136 such that the anchor can slide freely along the wire (e.g., as shown in the first frame of FIG. 2A and in FIG. 2B ). In this context, the term longitudinal (including in the specification and claims) generally means parallel to a central longitudinal axis ax1 of anchor 120. Although anchor 120 is described above as facilitating smooth sliding while the wire is straight and parallel to axis ax1, in actual use, the wire may not be perfectly straight or parallel to axis ax1.

[0324] When system 100 is in the delivery state, helical rotation of tissue engaging element 130 is configured to pull wire 112 proximally along the helix of the tissue engaging element until the wire eventually exits lumen 136 at proximal end 132 and remains threaded through aperture 146 of eyelet 140. This is shown in FIG. 2A , where delivery tool 150 has secured anchor 120 to tissue 10 of a subject. By securing anchor 120, delivery tool 150 transitions the system and / or device from the delivery state to the implanted state by (i) rotating the anchor such that tissue engaging element 130 is placed within the tissue, and (ii) pulling wire 112 proximally along the helix of the tissue engaging element until the wire exits lumen 136 and extends laterally through aperture 146 of eyelet 140.

[0325] As described above, when the wire 112 extends laterally through the aperture 146, the wire can slide smoothly through the aperture while being perpendicular to the axis ax1. The inventors hypothesize that this is useful, among other applications, in which the wire 112 is being tensioned to adjust an anatomical dimension, such as annuloplasty. Figures 3A-3B illustrate an application in which the tissue 10 represents the annulus tissue of a native heart valve, such as the mitral valve, and the implant 110 is an annuloplasty structure including the wire 112 and multiple anchors 120.

[0326] In FIG. 3A , multiple anchors 120 are secured to tissue 10. As described above, each anchor 120 (except possibly the first anchor 120a to be secured) is delivered to the tissue in a delivery state in which the wire 112 extends longitudinally through the lumen 136. Then, during securement, the wire 112 transitions to the illustrated implanted state in which the wire 112 extends laterally through the aperture 146 of the eyelet 140. After the desired number of anchors 120 are secured, an adjustment tool 170 is introduced, which can be disposed along the proximal portion of the wire 112 and used to facilitate tensioning the wire. While the wire 112 is being pulled proximally, a reference force (e.g., relative to the last anchor 120b to be secured) is provided by the tool 170 and / or the tube 152. The first end of the wire 112 cannot slide out of the first anchor 120a (e.g., is secured to the first anchor) due to, for example, the presence of the first stopper 114a. Thus, tension in wire 112 draws anchors 120 (e.g., anchors 120a and 120b) closer together, thereby contracting the tissue to which the anchors are secured (FIG. 3B). This is facilitated by eyelets 140, which, as described above, provide for smooth sliding of wire 112 through aperture 146 while the wire is perpendicular to the anchors. Tension is secured to implant 110, such as by securing second stopper 114b to wire 112 proximal to last anchor 120b. Excess wire 112 can then be cut and removed from the subject.

[0327] For simplicity, Figures 3A-3B show the implant 110 in a linear configuration. However, in annuloplasty, the implant 110 is often implanted in a curve (or complete ring) around the annulus, resulting in contraction that reduces the size of the annulus (e.g., reduces the radius) and improves leaflet coaptation.

[0328] In some applications, anchor driver 160 drives anchor 120 through engagement with eyelet 140. Thus, eyelet 140 not only facilitates sliding along wire 112 but also serves as driver interface 124 for anchor 120. To facilitate this, eyelet 140 may be rigidly coupled to tissue engaging element 130.

[0329] 1A-1C. For some applications, anchor 120 includes a single monolithic rod 180 having a sharpened distal tip 138 and a second tip 139, and is shaped to define all of the above-described components of the anchor. For such applications, rod 180 may be described as having (i) a first portion 182 shaped to define tissue-engaging element 130, and (ii) a second portion 184 continuous with the first portion and shaped to define eyelet 140. First portion 182 extends between (i.e., defined by) distal tip 138 and transition region 183 of the rod. Second portion 184 extends between (i.e., defined by) transition region 183 and second tip 139 of the rod. Tissue-engaging element 130 is formed by first portion 182, which extends helically around and along central longitudinal axis ax1 of anchor 120. The eyelet 140 is at least partially formed by a second portion 184 that forms an arch that spans laterally across the proximal end 132 of the tissue engaging element 130 and arches proximally in a direction away from the tissue engaging element (e.g., at least a proximal portion of the eyelet is formed).

[0330] For some applications, eyelet 140 is at least partially formed by second tip 139, which is attached to attachment site 186 of rod 180. Attachment site 186 is often within first portion 182 of rod 180, i.e., between distal tip 138 and transition site 183. For some applications, and as shown, tissue engaging element 130 may include multiple helical turns of rod 180, including (i) a distal-most helical turn defined distally by the distal tip of the rod and (ii) a proximal-most helical turn defined proximally by transition site 183, and attachment site 186 may be midway around the proximal-most helical turn. In some such applications, as shown in FIG. 1C , attachment site 186 may be at least one-third (i.e., at least 120 degrees) around (e.g., about halfway around) the proximal-most helical turn from transition site 183.

[0331] As described above, in the delivery state, wire 112 extends through lumen 136 past eyelet 140 and is then drawn proximally by rotating the helix of element 130 until it exits the lumen and is disposed through aperture 146 of eyelet 140. To facilitate this behavior, in the delivery state, wire 112 extends beyond a particular side of eyelet 140. The formation of eyelet 140 (e.g., from rod 180) may form a closed loop that includes (i) an arch formed by second portion 184 of the rod and (ii) a portion 185 of second portion 184 (e.g., a portion of the most proximal helical winding) disposed between transition region 183 and attachment region 186. In the delivery state, wire 112 can extend beyond eyelet 140 on the side 142 of the eyelet where the wire extends through this closed loop. The portion of wire 112 that is pulled proximally along the helix reaches the opposite side 144 of eyelet 140, whereby the wire is disposed through aperture 146 of eyelet 140 under the arch formed by portion 184. Another way to describe this disposal is that (i) the helix of tissue engaging element 130 leads to one side (side 144) of eyelet 140, and (ii) in the delivery state, wire 112 passes through eyelet 140 on the opposite side (side 142) of the eyelet and extends into lumen 136.

[0332] In some applications, anchor 120 and / or implant 110 may be used in combination with devices, systems, and / or may be implanted using methods / techniques mutatis mutandis in one or more of the following references, each of which is incorporated herein by reference in its entirety for all purposes: U.S. Patent Application Serial No. 14 / 437,373 (Sheps et al.), published as U.S. Patent No. 5,937,373 U.S. Patent Application Serial No. 15 / 782,687 (Iflah et al.), published as U.S. Patent No. 5,682,687 Patent Document 3 of Brauon et al. Brauon et al., U.S. Provisional Patent Application No. 62 / 811,693

[0333] See Figures 4A-4H and 5A-5C, which are schematic illustrations of example tissue anchors 220, implants 210 including the tissue anchors, systems 200 including the implants, and techniques for use therewith, according to several applications. System 200 is a tissue adjustment system and can be used to adjust the dimensions of tissue structures. For example, system 200 can be an annuloplasty system and implant 210 can be an annuloplasty structure (e.g., an annuloplasty ring, an annuloplasty implant, etc.).

[0334] Figures 4A, 4B, and 4F show respective isometric views of anchor 220, Figures 4D and 4G show respective side views of the anchor, Figure 4E shows an end view of the anchor looking distally along the central longitudinal axis ax2 of the anchor, and Figure 4C shows an exploded view of the anchor. Figure 4H shows a cross-section of eyelet 240 of anchor 220 (the location and orientation of the cross-section is shown in Figure 4E).

[0335] The anchor 220 includes a tissue-engaging element 230 and a head 280. The tissue-engaging element may be configured in a variety of ways. For some applications, as shown in FIGS. 4A-4G , the tissue-engaging element has a proximal end 232, a distal end 234, and defines a central longitudinal axis ax2 of the anchor 220. At the distal end 234, the tissue-engaging element 230 has a sharpened distal tip 238, and the tissue-engaging element is configured to be driven (e.g., screwed, pushed, etc.) into the subject's tissue. For some applications, and as shown, the tissue-engaging element 230 is helical and defines a central lumen 236 along the axis ax2. Optionally, the tissue-engaging element 230 may be another type of tissue-engaging element, such as a dart or staple. For some applications, the tissue-engaging element may be hook-shaped, straight, angled, and / or have another configuration. For some applications, the tissue-engaging element may include barbs or barbed portions for retaining the tissue-engaging element in tissue.

[0336] The tissue engaging element 230 has a lateral width d5. For applications in which the tissue engaging element 230 is helical, the width d5 ​​is the outer diameter of the helix. The head 280 is coupled to the proximal end 232 of the tissue engaging element 230 and includes a driver interface 282 and an eyelet 240 defining an aperture 246 therethrough. The driver interface 282 is configured to be reversibly engaged by the anchor driver 260. The driver 260 often includes an elongated, flexible shaft 261 and a driver head 264 coupled to the distal end of the shaft. The driver head 264 is the component of the anchor driver 260 that reversibly engages the driver interface 282. The driver interface 282 may be rigidly coupled to the tissue engaging element 230.

[0337] For some applications, and as shown, driver interface 282 is disposed on central longitudinal axis ax2 and eyelet 240 is disposed laterally from axis ax2.

[0338] As described in more detail below, and for the same reasons as described for anchor 120, mutatis mutandis, anchor 220 (e.g., its connector or eyelet 240) is configured to facilitate sliding of the anchor along a wire (or sliding of the wire through the anchor) while the anchor is aligned with the wire (e.g., while axis ax2 is parallel to the wire). As described in more detail below, anchor 220 (e.g., its connector or eyelet 240) is configured to facilitate sliding of the anchor along a wire (or sliding of the wire through the anchor) while the anchor is oriented orthogonal to the wire (i.e., axis ax2 is perpendicular to the wire). This is achieved at least in part by the shape and dimensions of connector or eyelet 240.

[0339] Eyelet 240 defines aperture 246 on aperture face 245 and is mounted such that the aperture face is inclined at a fixed angle α1 (see FIG. 4G) relative to axis ax2. In some applications, angle α1 is between 30 and 60 degrees (e.g., between 40 and 50 degrees, such as 45 degrees).

[0340] FIG. 4F, particularly its inset image, shows the eyelet 240 from a front view perpendicular to the aperture plane 245. The aperture 246 has a length d6 along the aperture's major axis ax3 and a width d7 along the aperture's minor axis ax4, both of which are disposed on the aperture plane 245. The length d6 is perpendicular to the width d7 and is often greater than the width d7. For example, the length d6 can be at least 1.4 times the width d7. For example, the length d6 can be 1.4 to 5 times the width d7, such as 1.4 to 3 times, such as 1.5 to 2.5 times, such as 1.6 to 2.2 times, such as 1.6 to 2 times, or 1.6 to 1.8 times, of the width d7.

[0341] In some applications, and as shown (e.g., in FIG. 4F), the ends of aperture 246 are rounded. In some applications, aperture 246 is shaped as a non-circular ellipse. In some applications, and as shown (e.g., in FIG. 4F), aperture 246 is shaped like a stadium—i.e., having rounded ends and straight sides (e.g., parallel to major axis ax3).

[0342] In some applications, and as shown (eg, in FIG. 4F), the minor axis ax4 is perpendicular to the central longitudinal axis and extends radially from the central longitudinal axis.

[0343] For some applications, eyelet 240 is shaped to form (i) a first clear, straight pathway through aperture 246 along a first line parallel to axis ax2 (e.g., as shown in FIG. 4E ) and (ii) a second clear, straight pathway through aperture 246 along a second line perpendicular to the first line (e.g., as shown in FIG. 4D ). This shape is hypothesized to advantageously allow eyelet 240 to slide along a wire in either of these mutually orthogonal orientations. Note that these pathways are not discrete, and the shape of eyelet 240 similarly facilitates sliding along a wire when in these mutually orthogonal pathway orientations.

[0344] Despite the actual shape of aperture 246 described above, eyelet 240 is shaped and dimensioned so that opening 246 appears circular when viewed both (i) along a first line (i.e., a first line of sight) parallel to axis ax2 (e.g., as shown in FIG. 4E ) and (ii) along a second line (i.e., a second line of sight) perpendicular to the first line of sight (e.g., as shown in FIG. 4D ). We hypothesize that this shape advantageously enables smooth sliding of eyelet 240 along the wire in either of these orientations (and typically also in a continuum of orientations therebetween). These lines of sight can therefore be considered the first and second sliding axes of anchor 220 (e.g., its eyelet 240). Furthermore, the inventors hypothesize that this shape advantageously allows such sliding even when the wire is greater than 50 percent (e.g., greater than 70 percent, e.g., greater than 90 percent) of the circular (i.e., width d7) apparent diameter of aperture 246.

[0345] To further facilitate smooth sliding of the wire through aperture 246, eyelet 240 forms a beveled edge around the aperture. In some applications, and as shown, beveling 248 is larger on major axis ax3 (i.e., the end of the aperture) than on minor axis ax4 (i.e., the sides of the aperture). In some applications, on each side of eyelet 240 (i.e., on either side of aperture 246), the eyelet defines a bathtub-shaped cavity where the bottoms of the bathtubs meet to form aperture 246.

[0346] In some applications, and as shown, eyelet 240 is mounted so as to be pivotable or rotatable about axis ax2, while aperture face 245 remains inclined at its fixed angle relative to the central longitudinal axis. Optionally, eyelet 240 may be pivotable or rotatable about another axis. For example, head 280 may include a ring 284 to which eyelet 240 is mounted. Ring 284 surrounds and is rotatable about axis ax2 by being rotatably coupled to tissue engaging element 230, such as by being rotatably coupled to another component of head 280 (e.g., driver interface 282) that is fixedly coupled to the tissue engaging element.

[0347] 4G, in some applications where the tissue engaging element 230 is helical, on the side of the anchor 220 where the eyelet 240 is disposed, the helix of the tissue engaging element is inclined relative to the axis ax2 in the same direction as the aperture surface 245. However, the lead angle α2 of the helix of the tissue engaging element 230 may be different from the angle α1 of the aperture surface 245. For example, as shown, the angle α2 may be greater than the angle α1 (e.g., 50% or more greater). Other tissue engaging element configurations are possible.

[0348] As described above, anchor 220 (e.g., its eyelet 240) is configured to facilitate sliding of the anchor along a wire (or sliding of a wire through the anchor) while the anchor is aligned with the wire (e.g., while axis ax2 is parallel to the wire). This is hypothesized by the inventors to facilitate transcatheter advancement of anchor 220 along the wire. As also described above, anchor 220 (e.g., its eyelet 240) is configured to facilitate sliding of the anchor along a wire (or sliding of a wire through the anchor) while the anchor is oriented perpendicular to the wire, i.e., while axis ax2 is perpendicular to the wire. The inventors hypothesize this is useful, among other applications, for tensioning a wire after implantation to adjust anatomical dimensions, such as annuloplasty. Figures 5A-5C illustrate an example application in which tissue 10 represents the annulus tissue of a native heart valve, such as the mitral valve, and implant 210 is an annuloplasty structure including wire 212 and multiple anchors 220.

[0349] 5A-5C show a system 200 including an implant 210 and a delivery tool 250 for percutaneous (e.g., transluminal, e.g., transfemoral) implantation of the implant. Delivery tool 250 includes a flexible anchor driver 260 configured to reversibly engage a driver interface 282 of an anchor 220. Through this engagement, driver 260 is configured to drive tissue engaging element 230 into tissue, for example, by rotating (and pushing distally) anchor 220. For some applications, delivery tool 250 further includes a flexible tube 252 (e.g., a transluminal catheter) through which each anchor 220 engaged with driver 260 can be advanced into tissue where the anchor is to be secured.

[0350] In Figure 5A, multiple anchors 220 have been secured to tissue 10. Each anchor 220 has been delivered to the tissue in a delivery state in which wire 212 extends through aperture 246 of eyelet 240 and is generally parallel to axis ax2. This is shown for anchor 220b, which is shown in Figure 5A as currently being delivered. The inset image of anchor 220b shows the clear, straight pathway that allows wire 212 to pass through aperture 246 of eyelet 240.

[0351] When a subsequent anchor 220 is secured to the same tissue, the wire 212 becomes oriented laterally relative to the anchor. Due to the configuration of the eyelet 240, despite this reorientation of the wire 212, the wire still has a clear, straight pathway through the aperture 246 of the eyelet 240. This is shown in the inset image of anchor 220a.

[0352] After the desired number of anchors 220 have been secured, an adjustment tool is introduced (e.g., over and along the proximal portion of wire 212) and used mutatis mutandis to facilitate tensioning of the wire, e.g., as described for implant 110 above. Tensioning of wire 212 thus draws anchors 220 closer together, thereby contracting the tissue to which they are secured (FIG. 5C). This is facilitated by eyelets 240, which, as described above, provide for smooth sliding of wire 212 through aperture 246 while the wire is perpendicular to the anchors. First stop 210a and second stop 214b can be used, mutatis mutandis, e.g., as described for implant 110 above. Excess wire 212 can then be cut and removed from the subject.

[0353] For simplicity, Figures 5A and 5C show the implant 210 in a linear configuration. However, in annuloplasty, the implant 210 is often implanted in a curve (or complete ring) around the annulus so that contraction reduces the size of the annulus and improves leaflet coaptation.

[0354] As noted above, in some applications, eyelet 240 is mounted so as to be pivotable or rotatable about axis ax2. This therefore provides independence between the rotational position of the eyelet and the rotational position of tissue-engaging element 230. For applications in which tissue-engaging element 230 is helical, this independence is hypothesized to advantageously allow the tissue-engaging element to be threaded into tissue to the extent necessary for optimal fixation without requiring the anchor to terminate in a specific rotational orientation. Furthermore, regardless of the type of tissue-engaging element 230 used, this independence is hypothesized to allow eyelet 240 (and wire 212) to be optimally positioned with respect to axis ax2 of each anchor 220 for a given application. For example, for applications in which implant 210 is used for annuloplasty, anchors 220 are often secured to a curve around the valve annulus, and eyelet 240 and wire 212 are often disposed on the inside of the curve with respect to axis ax2.

[0355] For some applications, and as shown, tube 252 is shaped to control the rotational position of eyelet 240 relative to axis ax2 and / or tissue-engaging element 230 during delivery and fixation. In some such applications, tube 252 defines an interior channel 254 that defines major and minor channel regions 254a and 254b ( FIG. 5B ). Major channel region 254a has a larger cross-sectional area than minor channel region 254b. Anchor 220 is slidable through channel 254, with tissue-engaging element 230 sliding (often snugly) through primary channel region 254a and eyelet 240 sliding (often snugly) along wire 212 through minor channel region 254b. Rotational control of tube 252 thereby controls the position of eyelet 240, and therefore wire 212, about axis ax2 of each anchor. The driver interface 282 and tissue engaging element 230 are rotatable within the tube 252, but the ring 284 and eyelet 240 are not. In some applications, and as shown, the channel 254 has an orthogonal cross-section that is keyhole shaped.

[0356] To anchor or secure anchor 220, anchor 260 advances from the distal end of tube 252 while rotating driver interface 282 (and thereby tissue engaging element 230) relative to the tube, while minor channel region 254b typically inhibits rotation of ring 284 relative to the tube. In some applications, it is advantageous for the distal end of the tube to be disposed (or even pressed) against tissue 10 during anchor fixation, as shown, for example, in FIG. 5A . In applications where tube 252 is used to implant an implant including multiple anchors on a wire, such as implant 210, interference may occur between the wire and the interface between the distal end of the tube and the tissue. In some applications, tube 252 defines a transverse slit 256 extending proximally from the distal end of the tube such that the slit is contiguous with the distal opening of the tube. For some applications, slit 256 allows wire 212, but not anchor 220, to exit tube 252 laterally proximally from the distal end of the tube adjacent minor channel region 254b (e.g., laterally outward). This is believed to facilitate implantation of an implant, such as implant 210, that includes multiple anchors coupled (e.g., threaded) to a wire.

[0357] For some applications, eyelet 240 facilitates sliding of wire 212 (i) while anchor 220 is aligned with the wire, and (ii) while the anchor is perpendicular to the wire, without aperture 246 being more than 5 percent wider than the wire. Thus, for some applications, wire 212 has a thickness that is greater than 50 percent (e.g., greater than 70 percent, e.g., greater than 90 percent) of width d7 of aperture 246. For some such applications, the thickness of wire 212 is less than 70 percent (e.g., between 30 and 60 percent) of length d6 of aperture 246.

[0358] For some applications, the length d6 is between 0.4 and 0.75 mm (e.g., between 0.42 and 0.67 mm). For some applications, the width d7 is between 0.15 and 0.5 mm (e.g., between 0.25 and 0.5 mm). For some applications, the wire 212 is between 0.1 and 0.6 mm (e.g., between 0.18 and 0.3 mm) thick.

[0359] 1A-5C. Both eyelet 140 and eyelet 240 are at a fixed angular arrangement relative to their respective tissue-engaging elements, with eyelet 140 rigidly coupled to its tissue-engaging element and eyelet 240 coupled to rotate but not flex. It is hypothesized by the inventors that limiting eyelet movement in this manner advantageously reduces wear on the wire passing through the eyelet.

[0360] 1A-5C, in both implant 110 and implant 210, the anchors remain threaded onto their respective wires during and after implantation, despite changes in the orientation of the wire relative to the anchor during implantation. This is hypothesized to advantageously reduce the likelihood of the anchors embolizing.

[0361] In some applications, anchor 120, implant 110, anchor 220, and / or implant 210 may be used in combination with a device, system, and / or may be implanted using methods / techniques mutatis mutandis in one or more of the following references, which are incorporated herein by reference in their entireties: U.S. Patent Application Serial No. 14 / 437,373 (Sheps et al.), published as U.S. Patent No. 5,937,373 U.S. Patent Application Serial No. 15 / 782,687 (Iflah et al.), published as U.S. Patent No. 5,682,687 Patent Document 3 of Brauon et al. Brauon et al., U.S. Provisional Patent Application No. 62 / 811,693

[0362] See FIGS. 6A-6E, 7A-7E, 8A-8E, 9A-9E, 10A-10E, 11A-11B, 12A-12B, 13A-13B, and 14A-14B, which are schematic illustrations of examples of tissue anchors and techniques for use therewith configured to facilitate determination of successful (e.g., complete) fixation in tissue not within line of sight, according to some applications. For example, such tissue anchors may be useful for percutaneous (e.g., transluminal) techniques as described elsewhere herein. FIGS. 6A-6E illustrate tissue anchor 300, according to some applications. FIGS. 7A-7E illustrate tissue anchor 310, according to some applications. FIGS. 8A-8E illustrate tissue anchor 320, according to some applications. FIGS. 9A-9E illustrate tissue anchor 330, according to some applications. 10A-10E illustrate tissue anchor 340, in accordance with some applications. 11A-11B illustrate tissue anchor 350, in accordance with some applications. 12A-12B illustrate tissue anchor 360, in accordance with some applications. 13A-13B illustrate tissue anchor 370, in accordance with some applications. 14A-14B illustrate tissue anchor 380, in accordance with some applications.

[0363] For each of tissue anchors 300, 310, 320, 330, 340, 350, 360, 370, and 380, the tissue anchor comprises: a tissue engaging element defining a central longitudinal axis of the anchor, the tissue engaging element having a sharpened distal tip, the tissue engaging element configured to be inserted into tissue of a subject; a head including a driver interface coupled to a proximal end of the tissue engaging element and configured to be reversibly engaged by an anchor driver; and a protrusion projecting distally away from the head to drive the tissue engaging element into the tissue, the protrusion configured to press the protrusion against the tissue and to automatically move relative to the head in response to being pressed against the tissue.

[0364] In some applications, the protrusion extends distally beyond at least the proximal end of the tissue-engaging element (i.e., the end of the tissue-engaging element closest to the head). Movement of the protrusion relative to the head facilitates determining successful fixation. In some applications, such as anchors 300, 310, 320, 330, 350, 360, 370, and 380, this movement is identified by imaging (e.g., fluoroscopy). For such applications, at least some portions of head 280 are radiopaque. In some applications, such as anchor 340, this movement is identified by the protrusion pressing against a pressure sensor.

[0365] For some applications, each of anchors 300, 310, 320, 330, 340, 350, 360, 370, and 380 is similar to anchor 220 described above, mutatis mutandis, unless otherwise noted. For example, and as shown, each of the anchors may include tissue engaging element 230 and head 280, mutatis mutandis. However, other tissue engaging elements and other heads may be used, mutatis mutandis. Similarly, each of the anchors may include driver interface 282. Furthermore, although eyelets are not visible in all of FIGS. 6A-14B, each of the anchors may include an eyelet described herein, such as eyelet 240 or eyelet 640, mutatis mutandis. Similarly, each of the anchors may include a ring described herein, such as ring 284, mutatis mutandis.

[0366] For some applications, anchor 300 includes protrusion 302. Anchor 310 includes projection 312. Anchor 320 includes projection 322. Anchor 330 includes projection 332. Anchor 340 includes projection 342. Anchor 350 includes projection 352. Anchor 360 includes projection 362. Anchor 370 includes projection 372. Anchor 380 includes projection 382.

[0367] For some applications, the prongs are configured to automatically, resiliently / reversibly move relative to the head in response to being pressed against tissue. For example, the prongs can include springs or can be coupled to head 280 via springs—i.e., the anchor can include a spring operatively coupled between the prongs and the head. Anchor 300 includes spring 304. Anchor 310 includes spring 314. Anchor 320 includes spring 324. Anchor 330 includes spring 334. Anchor 340 includes spring 344. Anchor 350 does not include a spring. Anchor 360 includes spring 364. Anchor 370 includes spring 374. Anchor 380 includes spring 384.

[0368] Each of Figures 6E, 7E, 8E, 9E, and 10E illustrates a respective tissue anchor secured to tissue in accordance with some applications. While Figures 6E, 7E, and 8E illustrate the tissue anchors as components of an implant similar to implant 210 (e.g., including wire 212), such tissue anchors may be used individually, mutatis mutandis, in a variety of other situations, as shown, for example, in Figures 9E and 10E. Similarly, anchors 330 and 340 in Figures 9A-9E and 10A-10E may optionally be used, mutatis mutandis, as components of an implant similar to implant 210 (e.g., including wire 212). In each of Figures 6E, 7E, 8E, 9E, and 10E, at least the right-most anchor has already been successfully secured, and the left-most anchor has not yet been successfully secured. Thus, these figures allow understanding of the anchor's operation (including movement of the prong relative to head 280) by comparing the left-side anchor with the other anchors.

[0369] Figures 11A, 12A, 13A, and 14A show the respective anchors before successful fixation, and Figures 11B, 12B, 13B, and 14B show the respective anchors after successful fixation. Thus, the operation of these anchors (including movement of the prongs relative to the head 280) can be understood by comparing a given Figure A with the corresponding Figure B.

[0370] In many cases, as shown in anchors 300, 310, 320, 330, 340, 350, 360, 370, and 380, the prongs are configured to automatically move proximally relative to the head in response to being pressed against tissue. That is, as tissue engaging element 230 moves distally of tissue 10, head 280 and prongs move distally toward the tissue, but because the prongs protrude distally away from head 280, the prongs reach the tissue before the head. When the prongs contact tissue, they stop moving distally, while head 280 continues to move distally toward the tissue relative to the prongs.

[0371] For some applications, the protrusions are disposed laterally outward from the tissue-engaging element. For example, protrusions 302, 312, 322, 362, 372, and 382 extend at least partially circumferentially around tissue-engaging element 230. Similarly, protrusions 332 and 352 are disposed laterally outward from tissue-engaging element 230, and for applications in which the anchor includes multiple protrusions 332 or 352, the protrusions are distributed circumferentially around the tissue-engaging element.

[0372] In some applications, the protrusions are disposed inward (e.g., radially inward) from the tissue-engaging element. For example, in some applications, the protrusions 342 are disposed inward from the tissue-engaging element 230, often on the central longitudinal axis of the tissue anchor. That is, in some applications of the anchor 340, the helical tissue-engaging element 230 extends helically around the protrusions 342.

[0373] In some applications, the protrusion and spring of the anchor are integrated regions of a monolithic structure, such that the spring may be considered part of the protrusion. For such applications, the protrusion (e.g., its spring portion) may be considered to automatically bend in response to the protrusion being pressed against tissue. Protrusion 302 and spring 304, protrusion 362 and spring 364, protrusion 372 and spring 374, and protrusion 382 and spring 384 are examples of such protrusion / spring pairs that may be integrated regions of their respective monolithic structures.

[0374] The protrusion 302 of the anchor 300 is a ring that can be configured to completely circumscribe the tissue-engaging element 230. In some applications, and as shown, the spring 304 is a helical compression spring that extends helically around the tissue-engaging element 230. In some applications, the spring 304 and the protrusion 302 are formed from a single helical coil, for example, with the proximal turn of the coil functioning as the spring 304 and the distal-most turn of the coil having a smaller pitch (e.g., a pitch of about zero) to form the protrusion 302. For the anchor 300, determining successful (e.g., complete) fixation to the tissue 10 is often made by fluoroscopic identification of the protrusion 302 approaching and / or contacting the head 280. Accordingly, the protrusion 302 (and optionally the spring 304) are often radiopaque.

[0375] For some applications, the tissue anchor includes a cuff extending at least partially around head 280, a central longitudinal axis of the anchor, and a distal portion of the cuff projecting distally away from the head to define a protrusion. For example, anchor 310 ( FIGS. 7A-7E ) includes cuff 316, the distal portion of which projects distally away from head 280 to define protrusion 312, and anchor 320 ( FIGS. 8A-8E ) includes cuff 326, the distal portion of which projects distally away from head 280 to define protrusion 322. Spring 314 is operatively coupled between cuff 316 and head 280, and spring 324 is operatively coupled between cuff 326 and head 280, respectively, such that each cuff is configured to automatically move proximally relative to head 280 in response to the distal portion of the cuff (i.e., the portion forming the protrusion) being pressed against tissue.

[0376] As shown in the left anchor in FIGS. 7B and 7E , at least a proximal portion of head 280 (e.g., driver interface 282) protrudes proximally from cuff 316 (e.g., when anchor 310 is in a resting state). As shown by the center and right anchors in FIG. 7E , cuff 316 is sized such that moving the cuff proximally relative to head 280 obscures the proximal portion of the head (e.g., driver interface 282). At least the proximal portion of the cuff is radiopaque. Thus, in a side fluoroscopic image, the shape of the proximal portion of head 280 is visible before anchor 310 is secured but becomes obscured after the anchor is successfully secured. In the particular example shown, the proximal portion of head 280 (e.g., of driver interface 282) has beveled edges, and therefore, the apparent shape change seen fluoroscopically is from a generally trapezoidal shape to a generally rectangular shape. However, various other shapes and other shape variations are possible.

[0377] Anchor 320 (FIGS. 8A-8E) is similar to anchor 310, except that it further includes one or more radiopaque indicators 328 (e.g., posts) extending proximally from cuff 326, and the cuff is dimensioned such that moving the cuff proximally relative to head 280 moves the indicator proximally beyond the proximal portion of the head, and becomes visible in a lateral fluoroscopic image after the anchor is successfully secured.

[0378] Protrusion 332 of anchor 330 (FIGS. 9A-9E) is formed by a distal portion of post 338 configured to move proximally (e.g., slide axially) relative to head 280 in response to being pressed against tissue. Spring 334 is operatively coupled between post 338 and head 280. For some applications, and as shown, anchor 330 includes multiple such posts and protrusions. In some such applications, anchor 330 includes a respective spring for each post 338.

[0379] In some applications, and as shown, anchor 330 includes head 280 and a cuff 336 that extends at least partially around a central longitudinal axis of the anchor, but unlike cuffs 316 and 326, is not configured to move proximally relative to head 280.

[0380] The protrusions 332 are radiopaque and can be seen in a side fluoroscopic image protruding distally (e.g., distally from the head 280 and / or cuff 336) prior to fixation, as shown in Figure 9E. As also shown in Figure 9E, in response to being pressed against the tissue 10, the posts 338 / protrusions 332 slide axially proximally (e.g., relative to the head 280 and / or cuff 336) and become less visible (e.g., invisible) in the side fluoroscopic image, thereby indicating successful fixation.

[0381] In some applications, post 338 is configured and dimensioned such that when the post is axially slid proximally in response to being pressed against tissue 10, the proximal portion of the post extends proximally beyond the proximal portion of head 280, thereby indicating successful fixation (mutatis mutandis, not shown, as described for anchor 350).

[0382] In some applications, cuff 316, cuff 326, and / or cuff 336 are pivotable or rotatable about the central longitudinal axis of their respective anchors. In some such applications, and as shown, the cuffs are coupled to rings that are rotatable about the central longitudinal axis of the anchors. For example, and as shown, in applications where the anchor includes ring 284 and eyelet 240, the cuff can be coupled to ring 284 on the opposite side of eyelet 240.

[0383] Similar to the protrusion 332 of anchor 330, the protrusion 342 of anchor 340 (FIGS. 10A-10E) is also formed by a distal portion of a post 348 configured to move proximally (e.g., slide axially) relative to head 280 in response to being pressed against tissue. In contrast to protrusion 332, protrusion 342 is disposed inward from tissue-engaging element 230, often on the central longitudinal axis of the tissue anchor. That is, in anchor 340, the helical tissue-engaging element 230 extends spirally around protrusion 342. In some applications, protrusion 342 is radiopaque, and its movement relative to head 280 can be used, mutatis mutandis, as described above, as a fluoroscopic indicator of successful fixation. Alternatively or additionally, movement of protrusion 342 / post 348 can be detected by a sensor (e.g., a pressure sensor) that is a component of the anchor driver. For example, as shown in FIG. 10E , anchor driver 260a may be provided as any embodiment of anchor driver 260 that includes a sensor (e.g., a pressure sensor) 262 at the distal end of the driver. Sensor 262 is contacted (e.g., pressed) by a proximal portion of post 348 upon proximal movement of the post relative to head 280. Sensor 262 may be positioned on driver 260a such that the sensor is disposed within head 280, e.g., distal to interface 282, while the driver is engaged with anchor 340. Sensor 262 is configured to provide a signal (e.g., an “anchor successful” signal) in response to being pressed by post 348. In some applications, and as shown, anchor driver 260a includes a wire extending from sensor 262 to a proximal portion of the anchor driver, and the sensor is configured to transmit a signal via the wire. Optionally, the sensor and / or system may be configured to provide a wireless signal.

[0384] Anchor 350 (FIGS. 11A-11B) is similar to anchor 330 in that it includes a protrusion 352 defined by a distal portion of a post 358 configured to move proximally (e.g., slide axially) relative to head 280 in response to being pressed against tissue. Unlike anchor 330, anchor 350 typically does not include a spring. In some applications, and as shown, anchor 350 includes multiple such posts and protrusions.

[0385] The protrusion 332 is radiopaque and can be seen in a side fluoroscopic image protruding distally (e.g., distally from the head 280) prior to fixation, as shown in Figure 11A. As shown in Figure 11B, in response to being pressed against the tissue 10, the post 358 / protrusion 352 slides axially proximally (e.g., relative to the head 280) such that the proximal portion of the post 358 becomes visible proximal to the head 280, thereby indicating successful fixation.

[0386] For some applications, the distal ends of posts 338, 348, and 358 (eg, prongs 332, 342, and 352) are blunt, eg, to facilitate their impaction by tissue without penetrating the tissue.

[0387] Anchor 360 ( FIGS. 12A-12B ) is similar to anchor 300 in that its projections, projections 362, are rings that can be configured to completely circumscribe tissue-engaging element 230, and in that determination of successful (e.g., complete) fixation to tissue 10 is often made by fluoroscopic identification of projections 362 approaching and / or contacting head 280. Accordingly, projections 362 are often radiopaque. Spring 364 of anchor 360 is a compression spring, but in contrast to spring 304, spring 364 is not helical. Rather, spring 364 includes multiple angle-shaped beams distributed circumferentially about a central longitudinal axis of anchor 360 (e.g., distributed circumferentially around a proximal portion of tissue-engaging element 230). The angle-shaped beams may all be in phase with each other (as shown), or some may be out of phase with the others.

[0388] Anchor 370 (FIGS. 13A-13B) is similar to anchor 300 in that its spring, spring 374, is a helical compression spring that extends helically around tissue engaging element 230. Similarly, spring 374 and protrusion 372 are often formed from a single helical coil, with a proximal portion of the coil functioning as the spring and a distal portion of the coil functioning as the protrusion. However, the helical coil of anchor 370 often only forms one full turn. For example, the helical coil can form 80-100% (e.g., 90-100%, e.g., 95-100%, e.g., 95-99%) of a full turn. In some applications, spring 374 resembles a helical split washer.

[0389] In response to being pressed against tissue, a first end (e.g., the proximal end) of the helical compression spring becomes aligned with a second end (e.g., the distal end defining protrusion 372) of the helical compression spring along the central longitudinal axis of the anchor. It is this alignment that is often detected fluoroscopically to determine successful fixation of anchor 370. (Note that using a helical compression spring with multiple full turns means that turns disposed between the distal and proximal ends of the spring prevent the ends from aligning with one another.)

[0390] Anchor 380 (FIGS. 14A-14B) is similar to anchor 300 in that its protrusions, protrusions 382, ​​are rings that can be configured to completely circumscribe tissue-engaging element 230, and in that determination of successful (e.g., complete) fixation to tissue 10 is often made by fluoroscopic identification of protrusions 382 approaching and / or contacting head 280. Accordingly, protrusions 382 are often radiopaque. Spring 384 of anchor 380 is a compression spring, but, in contrast to spring 304, spring 384 is not helical. Rather, spring 384 comprises a plurality of arches distributed circumferentially around a central longitudinal axis of anchor 380 (e.g., distributed circumferentially around a proximal portion of tissue-engaging element 230). As shown, spring 384 may include two or more layers (e.g., two layers) of such arches. For example, and as shown, spring 384 may include two layers of such arches, one layer inverted relative to the other so that the apex of the arches of one layer meets the apex of the arches of the other layer.

[0391] 15 , which is a schematic illustration of a tissue anchor 190, according to some applications. Anchor 190 includes a head, such as head 280, and a driver interface, such as driver interface 282. Anchor 190 also includes a tissue-engaging element 192. Tissue-engaging element 192 may include a helical tissue-engaging element. Tissue-engaging element 192 may be identical to or similar to tissue-engaging element 230, except that tissue-engaging element 192 has a knurled surface. It is hypothesized that the knurling on the surface of tissue-engaging element 192 facilitates fixation of the tissue-engaging element within tissue 10, for example, by helping to prevent the tissue-engaging element from working its way out of the tissue over time.

[0392] Refer again to Figures 6A-15. The tissue anchors described with respect to Figures 6A-15 may be substituted for one or more of the tissue anchors of the systems described herein (e.g., system 100, system 200, system 400, and / or system 600), mutatis mutandis. Similarly, the tissue anchors described elsewhere in this patent application may be modified to include one or more of the features of the tissue anchors described with respect to Figures 6A-15, such as prongs, springs, and / or knurled tissue-engaging elements. Furthermore, one of the tissue anchors described with respect to Figures 6A-15 may be modified to include one or more features of one or more of the other tissue anchors described with respect to Figures 6A-15.

[0393] 16A-16C, 17A-17C, 18, and 19A-19C are schematic illustrations of systems for facilitating controlled fixation of anchors to tissue, according to some applications. FIGS. 16A-16C and 17A-17C schematically illustrate system 400, and FIGS. 18 and 19A-19C schematically illustrate system 450. Each of systems 400 and 450 includes a flexible tube (e.g., a transluminal catheter), a tissue anchor, and an anchor driver, shown and described herein as driver 260. In either case, the anchor may include (i) a helical tissue-engaging element that extends helically about a central longitudinal axis to define the anchor's central longitudinal axis, has a sharpened distal tip, and is configured to be driven into the subject's tissue; and (ii) an anchor head coupled to a proximal end of the tissue-engaging element and including a driver interface.

[0394] In either case, the flexible tube (e.g., its sidewall) defines an internal channel from the proximal portion of the catheter to the distal portion of the catheter, and a distal opening in the distal portion of the catheter, where the channel often terminates. The anchor driver is often configured to advance the anchor through the channel and out of the distal opening, e.g., by rotating the anchor, to drive the tissue-engaging element into tissue. Thus, the tissue anchors, flexible tubes, and anchor drivers of systems 400 and 450 are similar to those of the other systems described herein. However, the flexible tubes (e.g., catheters) of each of systems 400 and 450 often further include a spool in the distal portion of the catheter. In either case, the spool protrudes (fixedly or retractably) inside the channel such that (i) it prevents the tissue-engaging element from passing distally through the spool in the absence of rotation of the tissue-engaging element, and (ii) it allows the tissue-engaging element to thread the spool distally. This is hypothesized by the inventors to reduce the likelihood of the tissue engaging element of the anchor becoming prematurely exposed from the tube (e.g., tissue and / or another part of the system may inadvertently catch on it) and / or reduce inadvertent excessive axial compression of the anchor against the tissue (e.g., as opposed to helically cork-screwing the anchor into the tissue).

[0395] System 400 (FIGS. 16A-16C and 17A-17C) includes a tissue anchor 410 and a flexible tube (eg, a catheter) 420. As shown in FIG.

[0396] The tissue anchor 410 comprises a head 412 and a tissue-engaging element 414. For some applications, the tissue-engaging element 414 is identical to or similar to the tissue-engaging element 230 or other tissue-engaging elements described above. For some applications, other than forming the groove 416, the head 412 is identical to or similar to the head 280 described above or other heads described herein, mutatis mutandis. The tube 420 (e.g., its sidewall 422) often defines an interior channel 424 from a proximal portion of the catheter to a distal portion of the catheter, and a distal opening 426 at the distal portion of the catheter, where the channel terminates. For some applications, the tube 420 is identical to or similar to one or more other flexible tubes described herein, except that it further includes a spool 430 that protrudes inwardly into the channel. In contrast to the spool 480 of the system 450 described below, the spool 430 often fixedly protrudes into the channel (e.g., is fixedly attached to the sidewall 422).

[0397] Figure 16A is a perspective view showing anchor 410 disposed within a distal portion of tube 420, while Figures 16B and 16C are perspective views showing anchor 410 alone in different states according to some applications. Figures 17A-17C are schematic illustrations of progressive stages in the fixation of anchor 410 using system 400 according to some applications.

[0398] The dimensions of the channel of tube 420, tissue-engaging element 414, and spool 430 are such that during axial advancement of anchor 410 distally through the catheter, once the tissue-engaging element reaches spool 430, the spool will prevent further distal advancement of the anchor unless the tissue-engaging element rotates ( FIG. 17A ). For some applications, and as shown, spool 430 is positioned longitudinally sufficiently proximal from distal opening 426 so that this occlusion occurs before any portion of anchor 410 (including its sharpened distal tip) is exposed from the distal opening. Optionally, spool 430 can be positioned longitudinally sufficiently distal so that when this occlusion occurs, the sharpened distal tip of tissue-engaging element 414 (but typically less than one full helical turn of the tissue-engaging element) is exposed from the distal opening.

[0399] Further distal advancement of anchor 410 is accomplished by rotating the anchor using, for example, driver 260, such that helical tissue engaging element 414 is threaded past spool 430 (FIG. 17B). FIGS. 17A-17B show the distal opening of tube 420 being held in contact with tissue 10. Thus, further distal advancement of anchor 410 threads tissue engaging element 414 into tissue 10.

[0400] In some applications, the head 412 is sized (e.g., sufficiently wide) so that the spool 430 prevents the head from axially passing the spool in at least one rotational position of the head relative to the tube 420. For such applications, the head 412 is often sized so that the head can slide axially past the spool 430 in at least one other rotational position of the head relative to the tube 420. In the example shown, a groove 416 parallel to the central longitudinal axis of the anchor 410 is defined in the outer surface of the head 412. The spool 430 prevents the head 412 from axially passing the spool in most rotational positions of the head relative to the tube, and the rotational alignment of the groove 416 with the spool defines a rotational position at which the head can axially move past the spool. Thus, in that rotational position, the spool can slide along the groove as the head axially passes the spool.

[0401] The anchor 410 is configured (e.g., by the relative rotational orientation between the tissue-engaging element 414 and the groove 416) so that, during advancement of the anchor, as the proximal end of the tissue-engaging element passes the spool 430, the groove becomes aligned with the spool, allowing the spool to be fanned axially past the head 412. Such a configuration is shown in FIG. 16B, where a transition zone 432 represents the location where the spool 430 exits between the helical turns of the tissue-engaging element 414 and enters the groove 416 during advancement of the anchor 410. FIG. 17C shows the anchor 410 advanced sufficiently such that the proximal end of the tissue-engaging element 414 has passed the spool 430, the groove is aligned with the spool, and the tube 420 has been retracted proximally, causing the head 412 to be fanned axially past the spool.

[0402] In the particular embodiment shown, the axial position of the spool 430 within the tube 420 is such that the spool 430 exits the proximal end of the tissue engaging element 414, and more than one turn of the tissue engaging element remains outside of the tissue 10. This remaining portion of the tissue engaging element 414 is then typically driven without the control provided by the spool 430. For other applications, the spool 430 is disposed near the distal opening 426, such that a lesser portion of the tissue engaging element 414 remains outside of the tissue 10 at the point where the spool 430 exits the proximal end of the tissue engaging element.

[0403] Thus, during use, at least some of the following steps are frequently performed: The anchor 410 advances axially with little or no rotation until the tissue engaging element 414 reaches the spool 430 . At that point, further advancement is helical, e.g., requiring rotation of the anchor such that the relationship between distal advancement and rotation follows the helical pitch of the tissue engaging element 414. This helical advancement often includes threading the tissue engaging element 414 into tissue. As the proximal end of tissue engaging element 414 passes through spool 430 , the spool slides axially through groove 416 with little or no rotation of anchor 410 . Once the spool 430 exits the proximal end of the groove 416, further helical advancement of the anchor 410 is possible to further thread the tissue engaging element 414 into tissue.

[0404] For some applications, anchor 410 includes features of other anchors described herein. For example, and as shown, head 412 may include eyelet 240, e.g., attached to ring 284, thereby rotatably coupling to another component of head 412, e.g., as described for anchor 220, mutatis mutandis. Additionally, as shown, tube 420 may have internal channels forming major and minor channel regions, e.g., as described for tube 252, mutatis mutandis. In some such applications, groove 416 axially traverses ring 284 so that the entire head 412 slides axially over spool 430. That is, the groove 416 has (i) at least one fixed groove section 416a defined by a portion of the head 412 that is rotationally fixed relative to the tissue engaging element 414 (and thereby the part 416a is rotationally fixed relative to the tissue engaging element), and (ii) at least one rotatable groove section 416b defined by the ring 284 and therefore rotatable about the central longitudinal axis of the anchor relative to the tissue engaging element (and relative to the driver interface 282).

[0405] In the example shown, the groove 416 has one pivotable groove section 416b adjacent to two fixed groove sections 416a. Figure 16B shows the anchor 410 with the fixed groove section 416a aligned with the pivotable groove section 416b, while Figure 16C shows the anchor with the fixed groove section rotated away from the pivotable groove section. For clarity, Figure 16C appears to show the pivotable groove section 416b in the same position as Figure 16B and the fixed groove section 416a in a different position than Figure 16B, but note that the fixed groove section remains rotationally fixed relative to the tissue-engaging element 414, while the tissue-engaging element rotates relative to the pivotable groove section.

[0406] In the particular example shown, groove section 416b (and the entire groove 416 when groove sections 416a and 416b are aligned) is disposed on the opposite side of eyelet 240, i.e., 180 degrees from the eyelet, about the central longitudinal axis of anchor 410. Similarly, spool 430 is disposed on the opposite side of the minor channel region of tube 420. Anchor 410 and tube 420 can also be configured for different rotational orientations of groove 416 by matching the position of spool 430 relative to the minor channel region with the position of the groove (or at least groove section 416b) relative to eyelet 240.

[0407] As noted above, groove section 416b is in a fixed rotational orientation relative to eyelet 240 and therefore appears in the same rotational position in FIGS. 17A, 17B, and 17C. FIG. 17A shows groove section 416a that is not rotationally aligned with spool 430. FIG. 17B shows anchor 410 after three full wraps of tissue engaging element 414 have been engaged in tissue 10 and groove section 416a has been returned to the same rotational position as in FIG. 17A. FIG. 17C shows anchor 410 after tissue engaging element 414 has been further engaged in tissue 10 until the proximal end of the tissue engaging element has passed spool 430. As shown, at that point groove section 416a is aligned with spool 430 and groove section 416b, thereby forming a complete groove 416 through which a spool can slide, for example, to allow tube 420 to be retracted as shown.

[0408] 17C. It will be appreciated that while the spool is disposed within groove section 406a, driver 260 is rotationally locked to tube 420 via head 412 of anchor 410. In some applications, this condition can be utilized by an operator to adjust the rotational orientation of tube 420 by applying torque to the tube via rotation of driver 260.

[0409] System 450 ( FIGS. 18 and 19A-19C ) includes a tissue anchor 460 and a flexible tube (e.g., a catheter) 470 including a sidewall 472 defining an internal channel 474 terminating in a distal opening 476. Tube 470 further includes a spool 480. Tissue anchor 460 comprises an anchor head 462 and a helical tissue-engaging element 464 defining a central longitudinal axis of the anchor, having a sharpened distal tip, and configured to be inserted into the subject's tissue. System 450 is similar to system 400 and offers similar advantages. However, in contrast to spool 430 of system 400, spool 480 of system 450 is at least partially retractable within sidewall 472 of tube 470. It is hypothesized that the retractability of spool 480 reduces (e.g., eliminates) the need for tissue anchor 460 to have special features (such as grooves) for passing the spool through it. Indeed, anchor 460 may be the same as or similar to anchor 220 described above or anchor 620 described below.

[0410] This allows spool 480 to reversibly transition between (i) an extended state in which the spool extends inwardly from the sidewall into channel 474, and (ii) a retracted state in which the spool is at least partially retracted into the sidewall. In the extended state, spool 480 inhibits anchor head 462 from passing axially through the spool. In the retracted state, spool 480 allows the head to pass distally through the spool.

[0411] For some applications, and as shown, tube 470 further comprises a pull wire 478 (e.g., within secondary channel 475 of tube 470) coupled to spool 480 and extending proximally from the spool along side wall 472 such that pulling the pull wire causes the spool to retract into the side wall. For such applications, spool 480 can typically be returned to its expanded state by releasing or pushing the pull wire. In some such applications, spool 480 includes or is coupled to another element that includes an elastic and / or shape-memory material that facilitates the reversible transition of the spool.

[0412] Figure 19A shows anchor 460 advanced axially distally through tube 470 until tissue engaging element 464 reaches spool 480, which prevents further distal advancement of the anchor in the absence of rotation of the tissue engaging element. Figure 19B shows anchor 460 advanced further distally while tissue engaging element 464 is rotated several times, resulting in the tissue engaging element being threaded past spool 480 and into tissue 10. Figure 19C shows spool 480 being retracted into secondary channel 475, allowing further advancement of anchor 460.

[0413] In some applications, the spool 480 is retracted only when the head 462 reaches the spool, such that retraction of the spool is necessary to further advance the anchor 460. In some applications, the spool 480 is retracted at any stage that the operator deems beneficial.

[0414] Systems 400 and 450, and / or features thereof, may be integrated into other systems described herein, for example, to provide the other systems with the advantages described for systems 400 and 450. For example, the tissue anchors, flexible tubes, and anchor drivers of other systems described herein may be substituted for those of systems 400 and / or 450.

[0415] Reference is made to Figures 20A-20D, which are schematic illustrations of a system 500 including an implant 510, according to some applications. System 500 is a tissue adjustment system and may be used to adjust the dimensions of a tissue structure. For example, system 500 may be an annuloplasty system and implant 510 may be an annuloplasty structure (e.g., an annuloplasty ring, an annuloplasty implant, etc.). System 500 (e.g., implant 510) may be used in a manner similar to that described for system 100, system 200, system 400, and / or system 600, mutatis mutandis.

[0416] The implant 510 includes at least one wire 512, multiple tissue anchors 520, and multiple connectors 540, each of which slidably couples to a wire and a respective anchor 520. (For simplicity, only one anchor 520 and one connector 540 of the implant 510 are shown.) Each anchor 520 includes a tissue-engaging element 530, a head 534, and a neck 532. The tissue-engaging element 530 defines a central longitudinal axis of the anchor, e.g., by extending helically about an axis, as described mutatis mutandis for other tissue-engaging elements above. The tissue-engaging element has a sharpened distal tip and is configured to be inserted into a subject's tissue, as described mutatis mutandis for other sharpened distal tips above. The neck 532 often extends along the central longitudinal axis of the anchor 520, thereby coupling the tissue-engaging element 530 to the head 534. Head 534 includes or forms a driver interface 536 configured to be reversibly engaged by an anchor driver, for example, as described mutatis mutandis above. Other tissue engaging element configurations are possible, as described elsewhere herein.

[0417] Each connector 540 comprises a flexible sheet (e.g., comprising a fabric and / or a polymer) shaped to define a hole 542 and at least one eyelet 546. A neck 532 extends through the hole 542 such that (i) the head 534 is disposed on a first side of the sheet, (ii) the tissue engaging element 530 is disposed on a second, opposite side of the sheet, and (iii) the anchor 520 is rotatable about its central longitudinal axis relative to the sheet by virtue of the neck rotating within the hole.

[0418] Wire 512 is threaded through eyelet 546, thereby slidably coupling the connector to the wire. In some applications, eyelet 546 is formed by a hem sewn into the flexible sheet.

[0419] 20A-20C, implant 510 includes two wires 512 (e.g., first wire 512a and second wire 512b), each connector 540 (e.g., its seat) is shaped to define two eyelets 546 (e.g., first eyelet 546a and second eyelet 546b), and each wire is slidably coupled to the anchor by threading through the respective eyelet. For example, and as shown, hole 542 can be defined between first eyelet 546a and second eyelet 546b such that anchor 520 (e.g., its neck 532) is disposed between first wire 512a and second wire 512b. For some applications, and as shown, wires 512a and 512b are generally parallel to one another.

[0420] Implant 510 may be implanted and adjusted using the techniques described for other systems described herein, mutatis mutandis. For example, anchors 520 may be sequentially secured around the annulus of a heart valve, such as the mitral valve, before wire 512 is pulled to constrict the annulus. Furthermore, these techniques and methods may be performed in a live animal or in a simulation, such as a cadaver, cadaver heart, simulator (e.g., where a body part, heart, tissue, etc. is simulated), etc.

[0421] The flexibility of the sheet of connector 540 is hypothesized by the inventors to provide system 500 with advantages similar to those described for systems 100, 200, 400, and 600, mutatis mutandis. For example, the flexibility of the sheet allows anchor 520 to slide along the wire (i) while generally parallel to the wire (e.g., during delivery) and (ii) while generally perpendicular to the wire (e.g., after implantation, during contraction).

[0422] 20D shows an embodiment 510a of implant 510 that differs from implant 510 shown in FIGS. 20A-20C in that it includes a single wire 512, instead of two wires, that is threaded through eyelet 546 of connector 540. For some applications, implant 510a includes an embodiment 540a of connector 540 that includes a single eyelet 546 on one side thereof, instead of two eyelets.

[0423] Reference is now made to Figures 70A-70C, which are schematic illustrations of a system 550 including an implant 560, according to some applications. System 550 is a tissue adjustment system and may be used to adjust the dimensions of a tissue structure. For example, system 550 may be an annuloplasty system and implant 560 may be an annuloplasty structure (e.g., an annuloplasty ring, an annuloplasty implant, etc.). System 550 (e.g., implant 560) may be used in a manner similar to that described for systems 100, 200, 400, 500, and / or 600, mutatis mutandis.

[0424] The implant 560 includes at least one wire 562, multiple tissue anchors 570, and multiple flexible sleeves 590, each sleeve slidably coupling a respective anchor 570 to the wire. (For simplicity, only one anchor 570 and one sleeve 590 of the implant 560 are shown.) Each anchor 570 includes a tissue-engaging element 580, a head 584, and a neck 582. The tissue-engaging element 580 may be configured similarly to other tissue-engaging elements herein. For some applications, the tissue-engaging element 580 defines a central longitudinal axis of the anchor by extending helically around an axis, e.g., as described mutatis mutandis for other tissue-engaging elements above. The tissue-engaging element has a sharpened distal tip and is configured to be engaged with the subject's tissue, as described mutatis mutandis for other sharpened distal tips above. The neck 582 often extends along the central longitudinal axis of the anchor 570, thereby coupling the tissue-engaging element 580 to the head 584. Head 584 includes or forms a driver interface 586 configured to be reversibly engaged by an anchor driver, for example, as described above mutatis mutandis. Head 584 further forms a head circumferential surface 588 about a central axis formed by the tissue engaging elements.

[0425] Each sleeve 590 can be made of a flexible fabric and / or polymer shaped to snugly cover at least a portion of the head 584, and more precisely, includes a sleeve circumferential portion snugly disposed around the head circumferential surface 588. The sleeve 590 further includes a proximal opening 594 disposed on the upper surface of the head 584 and dimensioned to expose the driver interface 586, such that a driver of the system 550 can engage the driver interface 586 without interference from the sleeve 590. The diameter of the proximal opening 594 can be at least as large as the diameter of the driver interface 586, although in some applications, the diameter of the proximal opening 594 can be smaller than the outer diameter of the head 584 and serve as an upper boundary for retaining the sleeve 590 coupled to the head 584. It should be understood that references to the diameter of the head 584 refer to the maximum distance between opposite sides of the head circumferential surface 588.

[0426] Sleeve 590 further comprises a distal opening 592 through which neck 582 can extend. The diameter of distal opening 592 can be at least as large as the diameter of neck 582, but in some applications can be smaller than the outer diameter of head 584, and serves as a lower boundary for coupling and retaining sleeve 590 to head 584. Anchor 570 is rotatable about its central longitudinal axis relative to sleeve 590, and neck 582 is configured to rotate within distal opening 592.

[0427] Sleeve 590 further includes at least one eyelet 598 disposed on at least a portion of sleeve circumferential portion 596. Wire 562 (or another wire, contractile member, etc.) is threaded through eyelet 598, thereby slidably coupling the sleeve to the wire. For some applications, eyelet 598 is formed by a patch or fabric strip coupled (e.g., sewn or glued) to sleeve 596 at its top and bottom.

[0428] 70A-70B, implant 560 includes two wires, lines, or contraction members 562 (e.g., first wire 562a and second wire 562b), each sleeve 590 includes two eyelets 598 (e.g., first eyelet 598a and second eyelet 598b) formed on opposite sides of sleeve circumferential portion 596, and each wire is slidably coupled to the anchor by threading it through a respective eyelet. For some applications, and as shown, wires 562a and 562b are generally parallel to one another.

[0429] Implant 560 can be implanted and adjusted using the techniques described for other systems described herein, mutatis mutandis. For example, anchors 570 can be sequentially secured around the annulus of a heart valve, such as the mitral valve, before wire 562 is tensioned to constrict the annulus. Furthermore, these techniques and methods can be performed in a live animal or in a simulation, such as a cadaver, cadaver heart, simulator (e.g., where a body part, heart, tissue, etc. is simulated), etc.

[0430] The inventors hypothesize that the flexibility of sleeve 590 provides system 550 with advantages similar to those described for systems 100, 200, 400, 500, and 600, mutatis mutandis. For example, the flexibility of the sleeve allows anchor 570 to slide along the wire (i) while generally parallel to the wire (e.g., during delivery) and (ii) while generally perpendicular to the wire (e.g., after implantation, during retraction).

[0431] 70C shows an embodiment 560a of implant 560, which differs from implant 560 shown in FIGS. 70A-70B in that it includes a single wire, line, or contraction member 562, instead of two wires, that is threaded through an eyelet 598 in the sleeve. For some applications, implant 560a includes an embodiment 590a of sleeve 590, which includes a single eyelet 598a on one side thereof, instead of two eyelets.

[0432] Reference is now made to Figures 21A-21G, 22A-22B, 23A-23B, 24, 25, 26, and 27, which are schematic illustrations of example tissue anchors 620, implants 610 including the tissue anchors, systems 600 including the implants, and techniques for use therewith, according to several applications. System 600 is a tissue adjustment system and can be used to adjust the dimensions of tissue structures. For example, system 600 can be an annuloplasty system, and implant 610 can be an annuloplasty structure (e.g., an annuloplasty ring, an annuloplasty implant, etc.).

[0433] System 600 may be identical to or similar to system 200 unless otherwise noted. Similarly, implant 610 and anchor 620 may be identical to or similar to implant 210 and anchor 220 unless otherwise noted.

[0434] Similar to implant 210, implant 610 includes a line or wire 212 and multiple anchors. However, implant 610 often further includes one or more tubular spacers 670 threaded onto wire 212. Each spacer is often disposed on wire 212 between adjacent pairs of anchors 620. Spacers 670 limit the proximity between pairs of anchors (i.e., the amount by which the pairs of anchors can move closer together when, for example, wire 212 is pulled). This effect and its benefits are discussed in more detail below.

[0435] Anchor 620 may be identical to or similar to anchor 220 and includes a head 680 that is often identical to or similar to head 280 of anchor 220, except that eyelet 640 of head 680 has a different shape (primarily a different external shape) than eyelet 240 of anchor 220. Nevertheless, the shapes and features described with reference to aperture 246 of eyelet 240 are often also present in aperture 646 formed by eyelet 640. For example, eyelet 640 defines an opening through which line or wire 212 is threaded, the opening being disposed laterally from a central longitudinal axis ax5 of the tissue anchor and mounted so as to be pivotable or rotatable, e.g., about axis ax5, with the opening remaining disposed at a fixed angle (e.g., oblique) relative to axis ax5. Additionally, similar to eyelet 240, eyelet 640 typically defines (i) a first clear, straight pathway through aperture 646 along a first line ax6 parallel to axis ax5, and (ii) a second clear, straight pathway through the opening along a second line ax7 perpendicular to the first line (e.g., as shown in Figures 21C-21D). With respect to eyelet 240, this is assumed by the inventors to facilitate smooth sliding along wire 212 in either of these orientations (and typically also in a continuum of orientations therebetween). Thus, line ax6 can be considered a first sliding axis of anchor 620 (e.g., that eyelet 640), and line ax7 can be considered a second sliding axis of anchor (e.g., that eyelet).

[0436] To distinguish it from eyelet 240, eyelet 640 has an exterior shape defining a tapered portion 642 that tapers in a direction away from opening 646 along slide axis ax7. This is best seen in FIGS. 21B and 21D , where the taper is indicated by line 644. Often, and as shown, each eyelet 640 has two tapered portions 642 (e.g., tapered portion 642a and tapered portion 642b), tapering from opening 646 in opposite directions along slide axis ax7. In some applications, each tapered portion has a taper angle α3 of 5 to 20 degrees (e.g., 5 to 15 degrees, e.g., 7 to 12 degrees, e.g., 8 to 10 degrees, about 9 degrees, etc.) relative to slide axis ax7. Thus, for such applications, the complete taper angle between the opposing sides of each tapered portion 642 is twice the angle α3, i.e., 10 to 40 degrees (e.g., 10 to 30 degrees, e.g., 14 to 24 degrees, e.g., 16 to 20 degrees, e.g., about 18 degrees).

[0437] Each spacer 670 has a first spacer end and a second spacer end, between which the spacer defines a spacer lumen 678. Each spacer 670 has a central portion 674 with an inner diameter d8. The spacer lumen 678 widens from the central portion 674 toward the spacer ends, for example, to form a first flared zone 676a and a second flared zone 676b. The flared zones 676 may have an internal flare angle α4 that is slightly (e.g., 1-3 degrees) less than the full taper angle of the tapered portion 642 of the eyelet 640. In some applications, the internal flare angle α4 is 10-40 degrees (e.g., 10-30 degrees, e.g., 12-22 degrees, e.g., 14-18 degrees, e.g., approximately 16 degrees). Each flared zone 676 is shaped to smoothly and snugly receive the tapered portion 642 of the eyelet 640.

[0438] In many cases, and as shown, the outer diameter of the spacer also increases from the central portion 674 to the spacer ends, with the flaring zone 676 and the spacer lumen 678 widening from the central portion 674 to the spacer ends. That is, the flaring zone 676 is often an external flare as well as an internal flare. However, in some applications, the flaring zone 676 may be internally flared without being externally flared. For example, in some such applications, the outer diameter of the spacer may be approximately constant along the length of the spacer.

[0439] In some applications, the spacers 670 are flexible in bending (e.g., elastically flexible). For example, and as shown, the spacers 670 may be defined by a helical wire. Despite being flexible in bending, in some applications, the spacers 670 are generally not axially compressible. That is, the axial compressive force applied to the spacer during use (e.g., due to tension in the wire 212) is insufficient to axially compress the spacer to any appreciable extent. For example, and as shown, the helical wire defining each spacer 670 may be shaped as a closed coil. This means that there are few, if any, gaps between the turns of the coil.

[0440] At the end of the spacer, the inner diameter d9 of the spacer 670 is large enough to allow the tapered portion 642 to enter the spacer lumen 678. For some applications, the diameter d9 is 0.5-1.5 mm, e.g., 0.7-1.1 mm, such as about 0.9 mm. For some applications, the diameter d8 of the central portion 674 is about half the diameter d9. For some applications, the diameter d8 is 0.2-0.8 mm, e.g., 0.3-0.6 mm, such as about 0.45 mm. The diameter d8 is often smaller than or up to 20% larger than the apparent circular shape of the aperture 646 (described above for aperture 246 mutatis mutandis), e.g., the circular aperture shown in FIG. 21C.

[0441] System 600 often includes a delivery tool 650 that includes anchor driver 260, and often includes a flexible tube 652 (e.g., a transluminal catheter) through which each anchor 620, engaged with driver 260, can be advanced into the tissue where the anchor is to be secured. System 600 is often used generally as described for system 200, mutatis mutandis. FIG. 22A shows multiple anchors 620 secured to tissue 10, with one anchor currently being advanced by driver 260 through tube 652. In addition to being threaded through the eyelets of anchors 620, wire 212 is also threaded through spacer 670 (i.e., its spacer lumen 678), often with one spacer between adjacent anchors, with one spacer end facing one anchor and the other spacer end facing another anchor for each spacer.

[0442] As seen in FIG. 22A , advancement of spacer 670 along wire 212 can be achieved by pushing the spacer with the eyelet of the anchor proximal to the spacer. In system 200, tube 252 defines lateral slit 256. In system 600, tube 652 defines lateral slit 656, which is similar in structure and function to slit 256 but is often specially dimensioned to allow spacer 670, along with wire 212, to exit the tube laterally proximally from its distal end, as shown, for example, in the leftmost spacer in FIG. 22A .

[0443] Similar to tube 252 of system 200, tube 652 (e.g., its sidewalls) defines an interior channel 654 that defines a first channel region 654a and a second channel region 654b (FIG. 22b). Often, channel region 654a is a major channel region and channel region 654b is a minor channel region, with the major channel region having a larger cross-sectional area than the minor channel region. For some applications, channel 654 has an orthogonal cross-section with a keyhole shape, e.g., as described for channel 254 mutatis mutandis. For some applications, and as shown, channel 654 has an orthogonal cross-section with a double-lobed shape with a constricted neck between the lobes. For some applications, and as shown, one lobe is larger than the other, whereby the larger lobe thereby forms the major channel region 654a and the smaller lobe thereby forms the minor channel region 654b.

[0444] FIG. 23A shows an implanted embodiment 610a of the implant 610, with anchors 620 secured to the tissue 10 in an arc around the annulus of the heart valve. In embodiment 610a, spacers 670 are disposed between each anchor. FIG. 23B shows embodiment 610a of the implant 610 after it has been contracted by tensioning the wire 212. Tensioning the wire 212 draws the anchors 620 together, reducing (e.g., eliminating) any space that may exist between each anchor and its adjacent spacer. Further tensioning draws the tapered portion of the eyelet 640 of the anchor 620 into the spacer lumen 678 of the spacer 670 (see inset in FIG. 23). As noted above, the relative dimensions and taper / flare angle facilitate smooth entry and a snug fit. For example, the arcuate shape of the implant 610 often facilitates smooth entry even when the spacer and eyelet are not perfectly aligned.

[0445] As noted above, spacer 670 limits the proximity between pairs of anchors 620. The inventors hypothesize that in some applications, this may even advantageously facilitate shrinkage of implant 610, for example, by inhibiting one pair of anchors from moving undesirably close together while another pair of anchors remains undesirably far apart. Moreover, more generally, the amount of shrinkage restriction between each pair of anchors can be planned in advance by increasing or decreasing the distance at which one anchor is secured from the other anchor relative to the length of the spacer between those anchors.

[0446] The particular dimensions of, and fit between, the eyelet 640 and the spacer 670 are hypothesized to provide a continuous, smooth path for the line or wire 212 through the implant (e.g., reducing the likelihood of friction and / or snagging). For example, the inventors hypothesize that the relative narrowness of the spacer lumen 678 in the central portion 674 advantageously centers the line / wire 212. Furthermore, the inventors hypothesize that the attachment between the eyelet 640 and the spacer 670 reduces the likelihood of undesirable lateral sliding or jumping of the spacer relative to the eyelet when the line / wire 212 is pulled. Thus, the inventors hypothesize that the fit between the eyelet 640 and the spacer 670 increases the predictability of the behavior of the implant 610 when the line / wire 212 is pulled.

[0447] FIG. 24 shows a similar implant but without the spacer 670 after contraction.

[0448] FIG. 25 shows embodiment 610b of implant 610 after contraction to demonstrate the use of a related but somewhat different spacer 670. In embodiment 610b, a spacer is disposed only between two end anchors at each end of wire 212, namely, anchors 620a and 620b and anchors 620e and 620d. FIG. 24 illustrates that, in some applications, without a spacer, the end anchors (in this case, anchors 620a and 620e) experience greater force from tensioned wire 212 than the anchors between them. This greater force may, in some circumstances, be too great for the end anchors and / or tissue, thus increasing the likelihood of one of the end anchors becoming unsecured from the tissue. Using a spacer 670 between an end anchor and an adjacent anchor ( FIG. 25 ) is believed to distribute the force between the anchors (e.g., because the end anchor presses the spacer against the adjacent anchor), reducing the excess force generated by the end anchor and thereby reducing the likelihood of the end anchor becoming unsecured.

[0449] Reference is now made to FIGS. 25 and 26, which are schematic illustrations of anchor 620 and spacer 670 being advanced over line or wire 212 within interior channel 654 of tube 652. As discussed above, in some applications, and as shown, channel 654 has an orthogonal cross-section with a double-lobed shape, with a narrowed neck between the lobes. FIGS. 25 and 26 illustrate the advantages of such a configuration, as postulated by the inventors. As noted above, when an anchor such as anchor 220 or anchor 620 is advanced through a catheter whose interior channel includes a dedicated channel portion for the anchor's eyelet and the line or wire through which the eyelet slides, the channel shape retains the eyelet within the dedicated channel portion. However, in some circumstances, a region of wire 212 distal to the eyelet may slip out of the dedicated channel portion and fall into the path of the anchor's tissue-engaging element, thereby increasing the likelihood of snaring.

[0450] 26 and 27 show a spacer 670 in channel region 654b, advanced by pushing the spacer with the anchor eyelet proximal to the spacer. FIG. 27 shows the neck of channel 654 having a width d11 smaller than the outer diameter d10 of spacer 670. The neck is thereby dimensioned to prevent the spacer from entering channel region 654a. Because spacer 670 is restrained from entering channel region 654a and the spacer extends distally from eyelet 640 (e.g., at least to the sharpened distal tip of tissue engaging element 230), the spacer prevents wire 212 threaded through the spacer from entering the portion of channel region 654a immediately distal to anchor 620. FIG. 26 shows the distal portion of wire 212, far from anchor 620, dropping into channel region 654a. As anchor 620 and spacer 670 are advanced distally, spacer 670 gradually moves the distal portion of wire 212 distally, out of the way of anchor 620, and back into channel region 654b.

[0451] Reference is now made to Figures 28A-28B, 29A-29B, 30, 31A-31B, 32, 33, and 34A-34B, which are schematic illustrations of example systems 1000, 1020, 1030, 1040, 1050, 1060, and 1070, respectively, for facilitating determination of successful (e.g., complete) fixation to tissue not within line of sight, according to some applications. Systems 1000, 1020, 1030, 1040, 1050, 1060, and 1070 include a respective tissue indication device 1010 coupled to a distal tubular end of a flexible tube 252 of a delivery tool 250 used to implant implant 210. Device 1010 is configured to mark / indicate tissue of the annulus, and thus device 1010 is configured to be an annulus marking or indication device for applications of the present invention. The tissue viewing device 1010 includes a radiopaque material to facilitate fluoroscopic visualization. As described above, the implant 210 includes multiple tissue anchors 220 and a contraction member (e.g., wires 212, lines, sutures, etc.). In some applications, the contraction member includes a metal wire. The delivery tool 250 is considered an anchor delivery tool because it facilitates delivery of the anchors 220 to the tissue 10. To properly identify when the tube 252 contacts the tissue 10, the tissue viewing device 1010 provides an indication, such as when it transitions from a resting state, as shown in, for example, FIGS. 28A, 29A, and 34A, to a compressed state, as shown in, for example, FIGS. 28B, 29B, and 34B.

[0452] The tissue indicating device 1010 includes a radiopaque material shaped to define a tubular body having a central longitudinal axis. The device 1010 is configured for placement in contact with the annulus of a subject's native heart valve. The device 1010 is (a) compressible to a compressed state in response to contact with tissue of the native heart valve and (b) expandable from the compressed state when no force is applied to the tissue indicating device 1010. The tissue indicating device 1010 is configured to provide a guide for implanting the tissue anchor 220 along the annulus during implantation of the tissue anchor 220. The device 1010 provides a real-time indicator of the presence of tissue in a compressed state. Once the anchor 220 is delivered, the tube 252 is pulled proximally to transition the device 1010 to its resting state, and the tube 252 is then moved to another location in the tissue 10 to contact tissue at the next location and transition to the compressed state in response to force applied thereto by the tissue 10. The device 1010 is retrievable following implantation of the implant 220.

[0453] To anchor or secure the anchor 220, the anchor is advanced from the distal end of the tube 252 and from the distal end of the tissue viewing device 1010. In some applications, it is advantageous to have the distal end of the tissue viewing device 1010 disposed (or even pressed) against the tissue 10 during anchoring, as shown, for example, in FIGS. 28B, 29B, and 34B. In some applications, the device 1010 comprises a tubular stent body. In some applications, the device 1010 comprises a superelastic material, such as nitinol or stainless steel.

[0454] 28A-28B, 29A-29B, and 30-32. For some applications, device 1010 is fabricated from laser-cut nitinol tubing, although other manufacturing options are available (e.g., cut from a sheet, formed, molded, printed, etc.). Device 1010 includes a proximal tube element (e.g., ring or tube) 1012, a distal tube element (e.g., ring or tube) 1014, and compressible elements 1018 and 1022, with a linking element 1016 connecting tube elements 1012 and 1014 together. Distal tube element 1014 is spaced a first distance from proximal tube element 1012 during a rest state of tissue viewing device 1010. In this manner, device 1010 has a height H1 in a rest state, as shown in FIGS. 28A and 29A. The distal tube element 1014 is spaced a second distance from the proximal tube element 1012 during the compressed state of the tissue viewing device 1010, the second distance being less than the first distance. In this manner, the device 1010 has a height H2 in the compressed state, as shown in Figures 28B and 29B.

[0455] Proximal tube element 1012 often defines a static element fixedly coupled to the distal end portion of tube 252, while compressible elements 1018 and 1022 and distal tube element 1014 define dynamic, movable elements. Upon contact with tissue, compressible element 1018 and distal tube element 1014 move longitudinally proximally toward proximal static tubular element 1012. The change in configuration of device 1010 brings the radiopaque elements closer together, resulting in a higher concentration of radiopaque material in device 1010 in its compressed state, discernible from fluoroscopic images as an indication of the presence of tissue in a particular region. In some applications, beads of tantalum or a similar material can be added to device 1010 to increase the radiopacity of device 1010.

[0456] In applications where tube 252 is used to implant an implant including multiple anchors on a wire, such as implant 210, interference may occur between the wire and the contact between the distal end of the tube and tissue in certain circumstances. For some applications, tube 252 defines a transverse slit 256 extending proximally from the distal end of the tube. In some applications, slit 256 allows wire 212, but not anchor 220, to exit tube 252 laterally proximally from the distal end of the tube. This is believed to facilitate implantation of an implant, such as implant 210, including multiple anchors coupled (e.g., threaded) to a wire. Accordingly, tissue viewing device 1010 of FIGS. 28A-28B, 29A-29B, and 30-33 is shaped to define a transverse slit 1013. Device 1010 is coupled to a distal end portion of tube 252 such that lateral slit 1013 of device 1010 is aligned with lateral slit 256 of tube 252. Slit 1013 extends proximally from the distal end of device 1010. For some applications, slit 1013 allows wire 212, but not anchor 220, to exit tube 252 and device 1013 laterally proximally from the distal end of the tube.

[0457] For some applications, as shown in FIGS. 28A-28B , the distal tube element 1014 is longitudinally longer than the proximal tube element 1012. The compressible element 1018, for some applications, comprises a spring including a coiled element, as shown. For some applications, the proximal tube element 1012 and the connecting element 1016 (or the compressible element 1018) surround the tubular distal end portion of the tube 252, and the connecting element 1016 is longitudinally compressible proximally along the tubular distal end portion of the anchor delivery tube 252, drawing the distal tube element 1014 toward the proximal tube element 1012. In such a configuration, the distal end portion to the tube 252 provides a path along which the connecting element 1016 and the distal tube element 1014 move and provides support and stability when they are compressed proximally.

[0458] For some applications, the distal tube element 1014 is shaped to define an opening. The tube 252 includes a pin that fits within the opening. The pin is configured to prevent rotation between the tube 252 and the device 1010.

[0459] 29A-29B, the proximal tube element 1012 is longitudinally longer than the distal tube element 1014. The compressible element 1022 comprises a spring including at least one strut element (e.g., first and second scaffold elements 1024 and 1026) that is compressible along the longitudinal axis of the tube 252. At least portions of the first and second scaffold elements 1024 and 1026 are spaced apart from one another during a rest state of the tissue viewing device 1010 (as shown in FIG. 29A), and portions of the first and second scaffold elements 1024 and 1026 move closer to one another during a compressed state of the tissue viewing device 1010 (as shown in FIG. 29B). For some applications, the proximal tube element 1012 surrounds the tubular distal end portion of the tube 252, and the connecting element 1016 (or compressible element 1018), the distal tube element 1014, is disposed distally relative to the distal end 1011 of the tube 252. The connecting element 1016 is longitudinally compressible proximally to draw the distal tube element 1014 toward the proximal tube element 1012.

[0460] 30, 31A-31B, and 32 illustrate tissue display device 1010, according to some applications. FIG. 30 illustrates tissue display device 1010 of system 1030, according to some applications. FIG. 31A illustrates tissue display device 1010 of system 1040, according to some applications. FIG. 31B illustrates tissue display device 1010 of system 1050, according to some applications. FIG. 32 illustrates tissue display device 1010 of system 1060, according to some applications.

[0461] Each device in systems 1030, 1040, 1050, and 1060 is shown with design variations that provide different radiopaque images. The proximal tube elements 1012 are often longer than the distal tube elements 1014 to provide stability to the elements 1012 when they are coupled to the tube 252 and also to provide increased surface area contact between the device 1010 and the tube 252. The linking elements 1016 each include a spring, strut-like or coiled element.

[0462] Although various tissue viewing devices are described and illustrated herein, other tissue viewing devices and tissue viewing device designs, as well as variations of the described devices, are possible.

[0463] FIG. 33 illustrates a variation of a system that may be the same or similar to other systems described herein, except that the tissue display device 1010 shown in FIG. 33 is a wire. This is a relatively simple design that also indicates or marks contact with tissue (e.g., a ring). The wire may be configured to move or compress upon contact with tissue. In some applications, the wire may be retractable and extendable relative to the tube or catheter, for example, configured to extend from the catheter and compress or contract within the tube / catheter when the wire is pressed against tissue. Movement of the wire relative to the tip (e.g., a radiopaque tip or end) of the tube / catheter may signal contact with tissue. In some applications, an electronic signal and / or sensor may be carried on or associated with the wire to indicate contact with tissue. The wire may take on various shapes and configurations. In some applications, the wire has a shaped portion 1054 at its end or tip (e.g., the distal tip or most distal tip), which may be horseshoe-shaped, semicircular, partially circular, or other shape. In some applications, as shown in FIG. 33 , the tissue viewing device and / or its wire includes two parallel sections 1056 that extend into separate lumens of the tube / catheter. These sections 1056 may be parallel to each other and / or may be the axis of the distal end of the tube / catheter. These parallel sections 1056 may be formed between channels or slits, which function similarly to the slits 1013 described above and may cooperate with the slits in the tube / catheter 256, providing the same advantages as described for similar slits. In applications having both a shaped distal portion 1054 and a parallel section 1056, the parallel section 1056 may be configured to extend from the tube / catheter to the shaped distal portion 1054 and connect them together.

[0464] For another example of a tissue viewing device, reference is now made to FIGS. 34A-34B. For some applications, the compressible element is braided from a plurality of wires. For some applications, the compressible element 1018 of the device 1010 includes a plurality of struts 1072. The struts may be arranged in a braided and / or interconnected arrangement. During the resting state of the tissue viewing device 1010 (FIG. 34A), the tissue viewing device assumes a first height H1, and during the compressed state (FIG. 34B), the tissue viewing device 1010 assumes a second height H2 that is shorter than the first height H1. During the compressed state, the tissue indicating device 1010 shortens longitudinally and expands radially. The plurality of struts 1072 includes a subset of rounded struts 1074 at the distal end of the tissue viewing device 1010 to facilitate atraumatic contact between the device 1010 and the tissue 10. For some applications, each of the plurality of rounded struts 1074 includes a closed loop.

[0465] For some applications, the braided mesh provided by the struts 1072 allows the device 1010 to change shape to conform to the topography of the valve annulus. For some applications, the struts 1072 include a metal alloy. For some applications, the struts 1072 include nitinol and / or stainless steel.

[0466] Reference is now made to Figures 35A-35B, 36A-36B, 37A-37B, 38A-38B, 39A-39B, 44A-44B, 45A-45B, and 46A-46B, which are schematic illustrations of example systems 1080, 1090, 1100, 1200, 1300, 1800, 1820, and 1830, respectively, for covering excess contraction member after the contraction member has been cut following contraction, according to some applications. Systems 1080, 1090, 1100, 1200, 1300, 1800, 1820, and 1830 each include a respective contraction member covering device 1082, 1092, 1102, 1202, 1302, 1802, 1822, and 1832 that are coupleable to a contraction member (e.g., wire 212, line, suture, etc.) near a distal tissue anchor 1220 of anchor 220 of implant 210. For some applications, the contraction member covering devices described herein include a fastener configured to secure wire 212 in place after annuloplasty is performed by tightening. For some applications, the contraction member covering devices described herein do not include a fastener and are advanced toward implant 210 once implant 210 is locked by a separate fastener (or any suitable locking mechanism) separate from the contraction member covering device. For some applications, the contractile member covering devices described herein are configured to expand to cover excess portions of wires 212 and ends 213. For some applications, the contractile member covering devices described herein are configured to change shape to cover excess portions of wires 212 and ends 213. For some applications, the contractile member covering devices described herein are configured to cover excess portions of wires 212 and ends 213 by pulling excess portions of wires 212 and ends 213 into a housing of the contractile member covering device.In some applications, the contractile member covering device is intended to cover excess portions of wire 212 and end 213 and is not sufficient by itself (i.e., without a fastener coupled to wire 212 near or within the device housing) to facilitate locking or immobilizing wire 212. That is, in some applications, the contractile member covering device does not, by itself, provide sufficient force to lock or immobilize wire 212 and overcome tension in wire 212.

[0467] Because the contraction member includes the wire 212, it is advantageous to cover the free end 213 of the wire 212 and any excess portion of the wire 212 when the wire 212 is clipped or cut following tightening of the implant 210 to perform the annuloplasty. Covering the free end 213 of the wire 212 and any excess portion of the wire 212 prevents tissue damage that may be caused by the metal of the wire 212 being exposed to tissue after the wire 212 is cut. Furthermore, covering the free end 213 of the wire 212 and any excess portion of the wire 212 prevents additional fibrosis around the free end 213 of the wire 212 and any excess portion of the wire 212. It is advantageous for the contraction member to include a metal wire because metal is stronger and more durable than, for example, woven sutures. Furthermore, the metal of the wire 212 is radiopaque and can be seen under fluoroscopy during the annuloplasty procedure.

[0468] 35A-35B, 36A-36B, 37A-37B, 38A-38B, and 39A-39B. Each of the contraction member covering devices 1082, 1092, 1102, 1202, and 1302 includes a housing 1430 that houses a contraction member fastener 1460, which defines the locking mechanism of the system. The fastener 1460 is shaped to define a generally rectangular, planar clip comprising a superelastic material, e.g., Nitinol. The fastener 1460 includes a deformable element shaped to define a plurality of slits surrounded by a plurality of flexible legs 1462 that allow the clip to transition between an angled ( FIGS. 35A, 36A, 37A, 38A, and 39A) and a straight ( FIGS. 35B, 36B, 37B, 38B, and 39B) state. The contraction wire-engaging surface of the clip is shaped to define a plurality of teeth (not shown for clarity of illustration). For some applications, the teeth are jagged. For some applications, the top surface of the clip is flat without teeth. The teeth are configured to increase friction between the wire 212 and the fastener 1460.

[0469] It should be noted that fastener 1460 is used by way of example and not limitation, and any suitable fastening means, fasteners, clips, etc. may be used.

[0470] The fastener 1460 includes (a) a clamping structure biased to assume a closed state ( FIGS. 35B , 36B , 37B , 38B , and 39B ). In the closed state, the clamping structure is configured to clamp onto the passed wire 212, and (b) is bendable to an open state ( FIGS. 35A , 36A , 37A , 38A , and 39A ) that allows the wire 212 to pass therethrough. In the closed state, the fastener 1460 is configured to restrict movement of the wire 212 relative to the plurality of anchors 220.

[0471] The wire extends through an opening 1434 in the housing 1430 and through a stop 1472 (e.g., a holder) disposed in the opening of the housing 1430 near the contraction member fastener 1460. The stop 1472 may be shaped to define a lumen therethrough for the surrounding wire 212. The stop 1472 is engageable by and removable from the housing 1430 via a tool 1502. The stop 1472 is shaped to fit snugly within a channel extending from the opening 1434 and presses against the contraction wire-engaging surface of the clip to maintain the fastener 1460 in the tilted state, i.e., in the unlocked state of the fastener 1460. In the tilted state shown in FIGS. 35A , 36A , 37A , 38A , and 39A , the clip deforms and does not press against the wire 212. In the tilted state, the wire 212 is free to move relative to the fastener 1460, the housing 1430, and the stop 1472. The wire 212 is pulled until the annulus-forming structure is sufficiently contracted.

[0472] 35B, 36B, 37B, 38B, and 39B, the stop 1472 has been disengaged and removed from the housing 1430. When no force is being applied to the retraction wire-engaging surface of the clip by the stop 1472, the clip returns to its resting, straight state, trapping the wire 212 between the retraction wire-engaging surface of the clip and a surface 1432, e.g., an interior wall, of the housing 1430. The fastener 1460 is thus in a locked state in which the clip locks and crimps the wire 212.

[0473] Once all of the tissue anchors 220 are implanted, the wire 212 is threaded through the constriction member covering device delivery and constriction member cutting tool 1502, which is advanced along the wire 212 to the anchors 1220. The relative spatial orientation of the components of the tool 1502 allows the wire 212 to pass straight and directly through the lumen of the tool 1502 and along the longitudinal axis of the tool 1502, without taking a winding path through the tool 1502. This direct, unwinding path of the wire 212 through the tool 1502 reduces friction on the wire 212 as it moves within the tool 1502. The orientation of the components of the tool 1502 allows this direct path of the wire 212.

[0474] The tool 1502 includes a static cutting element 1510 and a movable dynamic cutting element 1520, each of which defines a sharp edge. The dynamic cutting element 1520 slides proximally and obliquely relative to the static cutting element 1510. The tool 1502 includes a stop 1472 configured to facilitate proximal movement of the stop 1472 such that the stop 1472 is displaced from within the housing 1430 and through the opening 1434. When the stop 1472 is displaced from within the housing 1430, the fastener 1460 assumes a closed position to trap the wire 212 between the clamping surface of the fastener 1460 and the surface 1432 of the housing 1430. Such displacement of the stop 1472 also allows the stop 1472 to push (e.g., by striking) the dynamic cutting element 1520 proximally so that the dynamic cutting element 1520 slides obliquely proximally along the static cutting element 1510, such that the elements 1510 and 1520 cut and sever the wire 212. Thus, the tool 1502 provides a mechanism that allows for simultaneous cutting and locking of the wire 212.

[0475] Thus, tool 1502 is advantageously positioned to provide a safety mechanism such that it can only be severed by a proximal force applied to wire 212 by stop 1472 after fasteners 1460 have transitioned to a fixed or locked state and wire 212 has been locked in place. That is, tool 1502 cannot inadvertently cut wire 212 while tool 1502 is not coupled to stop 1472 and stop 1472 is not pressing against cutting element 1520. In one swift motion, tool 1502 (1) locks wire 212 in place by transitioning fasteners 1460 to a locked state and (2) cuts wire 212.

[0476] 35A-35B, the constriction member covering device 1082 includes a flap 1084 disposed on the exterior of the housing 1430. The flap 1084 is movable from (1) an open state in which the flap 1084 is spaced apart from the housing 1430 to (2) a closed state in which the flap 1084 is disposed along the housing 1430 in such a manner that the flap 1084 presses the excess portion of the wire 212 exiting the housing 1430 through the opening 1434 and the end 213 of the wire 212 against the exterior surface of the housing 1430 while also covering the excess portion of the wire 212 and the end 213 of the wire 212. Additionally, the flap 1084 covers the opening 1434 of the housing 1430. The flap 1084 is coupled to the housing 1430 in a manner that allows it to pivot from a first open position, in which it is aligned with a first side wall of the housing 1430, as shown in FIG. 35A, to a second closed position, in which it is aligned with a second side wall of the housing 1430, as shown in FIG. 35B. In the second position, the flap 1084 captures the excess portion of the wire 212 and end 213 between the flap 1084 and the second side wall of the housing 1430. In some applications, the device 1082 tends to assume the second closed position when no force is applied to it. For example, the device 1082 is held in the first open position by the presence of the tool 1502. When the tool 1502 locks and cuts the wire 212, the tool 1502 disengages from the housing 1430 and moves proximally, allowing the flap 1084 to change shape and transition to the second closed position. In such applications, the flap 1084 acts as a spring.

[0477] For some applications, the housing 1430 is covered with a braided fabric mesh, not shown.

[0478] The flap 1084 includes two metal scaffolding beams 1086 disposed opposite each other. A portion of the fabric 1088 is bonded to and extends between the two metal scaffolding beams 1086 such that, when the flap 1084 is closed, the fabric 1088 covers the excess portions of the wires 212 and the ends 213 of the wires 212 and covers the opening 1434 in the housing 1430. Each scaffolding beam 1086 has two sub-beams 1086a and 1086b between which the fabric 1088 is bonded and held in place.

[0479] 36A-36B, the constriction member covering device 1092 includes a flap 1094 disposed on the exterior of the housing 1430. The flap 1094 is movable from (1) an open state in which the flap 1094 is spaced apart from the housing 1430 to (2) a closed state in which the flap 1094 is disposed next to the housing 1430 in such a manner that the flap 1094 presses the excess portion of the wire 212, which exits the housing 1430 through the opening 1434 and the end 213 of the wire 212, against the exterior surface of the housing 1430.

[0480] The flap 1094 is coupled to the housing 1430 in a pivotable manner from a first open position, as shown in FIG. 36A , to a second closed position, as shown in FIG. 36B , in which the flap 1094 is aligned with the sidewall of the housing 1430. In the first position, the flap 1094 is aligned with the longitudinal axis of the tool 1502. The flap 1094 is coupled to the housing 1430 via a hinge 1095, which facilitates the device 1092 changing shape and moving the flap 1094 from the first position to the second position. In the second position, the flap 1094 captures excess portions of the wire 212 and end 213 between the flap 1094 and the second sidewall of the housing 1430. In some applications, the device 1092 tends to assume the second closed position when no force is applied. For example, the device 1092 is held in the first open position by the presence of the tool 1502. Once the tool 1502 locks onto and cuts the wire 212, the tool 1502 disengages from the housing 1430 and moves proximally, allowing the flap 1094 to change shape and transition to the second, closed position. In such an application, the flap 1094 acts as a spring.

[0481] For some applications, the housing 1430 is covered with a braided fabric mesh, not shown.

[0482] The flap 1094 is comprised of two facing metal scaffolding beams 1096 and a cross beam 1098 extending between the two facing metal scaffolding beams. During the transition of the device 1092 between the first and second states, the cross beam 1098 presses against the excess portion of the wire 212. In the closed state, the cross beam 1098 keeps the excess portion of the wire 212 and the end 213 of the wire 212 pressed against the exterior surface of the housing 1430.

[0483] In some applications, a piece of fabric is coupled to and extends between the two metal scaffolding beams 1096 such that when the flaps 1094 are closed, the fabric 1099 covers the excess portions of the wires 212 and the ends 213 of the wires 212 and covers the openings 1434 in the housing 1430.

[0484] 37A-37B. The contractile member covering device 1102 includes a helical spring 1104 movable along a path 1106 defined by a housing 1430. The device 1102 is configured to cover the excess portion and end 213 of the wire 212 by pulling the excess portion and end 213 of the wire 212 into the housing 1430. In this manner, the device 1102 facilitates the uptake of the excess portion and end 213 of the wire 212 into the housing 1430 by pulling the excess portion and end 213 of the wire 212 through the opening 1434 and along the path 1106. The wire 212 passes along the end of the helical spring 1104. The end of the helical spring 1104 includes a crossbeam 1105. The helical spring 1104 is movable from (1) an open state in which the spring 1104 is preloaded and constrained, with the crossbeam 1105 at a first position 1105 in the path 1106, to (2) a closed state in which the spring 1104 is relaxed, with the crossbeam 1105 at a second position 1107 in the path 1106. As the spring 1104 transitions from its open state ( FIG. 37A ) to its closed state ( FIG. 37B ), the crossbeam 1105 pushes the excess portion of the wire 212 and the end 213 of the wire 212 along the path 1106 and away from the opening 1434 in the housing 1430. In some applications, the opening 1434 automatically closes when the wire 212 is withdrawn from the housing 1430. In some applications, housing 1430 is covered with a braided fabric mesh, not shown, that closes over opening 1434 when wire 212 is pulled into housing 1430 .

[0485] Spring 1104 is made of a superelastic material such as Nitinol.

[0486] In some applications, device 1102 tends to assume a closed state when no force is applied thereto. For example, device 1102 is held in an open state by the presence of tool 1502. When tool 1502 locks onto and cuts wire 212, tool 1502 disengages from housing 1430 and moves proximally, drawing stop 1472 proximally. As shown, in the open state of device 1102, stop 1472 is partially disposed within passage 1106, thereby (a) maintaining fastener 1460 open when tool 1052 is coupled to housing 1430, and (b) maintaining crossbeam 1105 out of engagement with wire 212, thereby restricting movement of crossbeam 1105 and spring 1104. When stop 1472 moves proximally from within path 1106 and stop 1472 is no longer present, movement of cross beam 1105 is no longer restricted and cross beam 1105 is able to move along path 1106, and as it moves, it pushes wire 212 along path 1106 so that the excess portion of wire 212 and end 213 of wire 212 are pulled, collected, and covered within housing 1430 and along path 1106.

[0487] 38A-38B, the contractile member covering device 1202 includes a spring 1204 coupled to the housing 1430 near the opening 1434. The spring 1204 is configured to expand to cover the excess portion of the wire 212 exiting the housing through the opening 1434 and the end 213 of the wire 212. The spring 1204 includes a pusher element 1205, which includes a superelastic material such as, for example, Nitinol, and is configured to push against the fabric 1206 surrounding the housing 1430 and the spring 1204. The device 1202 is movable from (1) a compressed state in which the spring 1204 is longitudinally compressed and the fabric 1206 is slack, to (2) an expanded state in which the spring 1204 expands longitudinally such that the push element 1205 pushes against the fabric 1206 so that the excess portion of the wire 212 exiting the housing 1430 through the opening 1434 and end 213 of the wire 212 is wrapped and covered by the device 1202 to expand the fabric 1206.

[0488] In some applications, device 1202 tends to assume an expanded state when no force is applied to it. For example, device 1202 is held in a compressed state by the presence of tool 1502. When tool 1502 locks and cuts wire 212, tool 1502 disengages from housing 1430 and moves proximally, allowing spring 1204 to change shape and transition to an extended position.

[0489] The spring 1204 includes two metallic compressible scaffolding elements disposed opposite one another. The scaffolding elements are configured to expand laterally away from a wall of the housing 1430 that defines the opening 1434. As shown, the scaffolding elements include a sinusoidal pattern. It should be noted that the scaffolding elements may take any suitable pattern.

[0490] For some applications, fabric 1206 is configured to promote tissue growth.

[0491] 39A-39B, the constriction member covering device 1302 comprises an expandable woven tube 1304 coupled to the housing 1430 near the opening 1434. The expandable woven tube 1304 is configured to expand to cover the excess portion of the wire 212 exiting the housing 1430 through the opening 1434 and the end 213 of the wire 212. The device 1302 is movable from (1) a compressed state in which the expandable woven tube 1304 is longitudinally compressed to (2) an expanded state in which the expandable woven tube 1304 is longitudinally expanded such that the tube 1304 covers the excess portion of the wire 212 exiting the housing 1430 through the opening 1434 and the end 213 of the wire 212.

[0492] In some applications, device 1302 tends to assume an expanded state when no force is applied to it. For example, device 1302 is held in a compressed state by the presence of tool 1502. When tool 1502 locks and cuts wire 212, tool 1502 decouples from housing 1430 and moves proximally, allowing expandable woven tube 1304 to change shape and transition to an expanded position.

[0493] For some applications, device 1302 is surrounded by fabric 1306 configured to promote tissue growth.

[0494] Reference is now made to FIGS. 40A-40B, which are schematic illustrations of an example system 1400 including a locking mechanism including a fastener 1402 configured to be coupleable to a wire 212 (i.e., a contraction member) near a distal tissue anchor 1220 of the plurality of tissue anchors 220, according to some applications. The fastener 1402 is configured, in its closed state (FIG. 40B), to restrict movement of the wire 212 relative to the plurality of tissue anchors 220. The fastener 1402 includes a housing 1404 shaped to define (a) a first lumen 1405 for passing the wire 212 therethrough, and (b) a second lumen 1403 disposed at a non-zero angle relative to the lumen 1405. For some applications, the second lumen 1403 is in fluid communication with a portion of the first lumen 1405. The first lumen 1405 extends along a longitudinal axis of the housing 1404.

[0495] The fastener 1402 includes a locking ball 1412 that is movable within the second lumen 1403 from a first position ( FIG. 40A ) in which the locking ball 1412 does not apply pressure to the wire 212 to a second position ( FIG. 40B ) in which the locking ball 1412 applies pressure to the contraction member 212 by either direct contact with a portion of the wire 212 or by applying pressure to the inner wall of the second lumen 1403, which applies pressure to the first lumen 1405 and the wire 212 passing therethrough. Applying pressure to the wire 212, either directly or indirectly by locking the ball 1412 to the wire 212, restricts movement of the wire 212. An advancement pin 1410 is disposed within the second lumen 1403 proximal to the locking ball 1412. The advancement pin 1410 is configured to advance the locking ball 1412 from a first position to a second position, causing the ball 1412 to apply pressure to the wire 212, locking the wire 212 between the ball 1412 and the inner wall of the first lumen 1405.

[0496] The second lumen 1403 has a first sublumen 1406 sized to accommodate an advancement pin 1410 and a second sublumen 1408 sized to accommodate a locking ball 1412. The first sublumen 1406 is disposed proximal to the second sublumen 1408. Often, the second lumen 1403, or at least the first sublumen 1406, has a threaded surface. The advancement pin 1410 has a threaded outer surface. The threaded surface facilitates locking of the locking ball 1412 in the second position. The thread pitch of the threaded surface is 1.5 mm.

[0497] The delivery tool 1411 is configured to deliver the fastener 1402 along the wire 212. The delivery tool 1411 includes a torque transfer tool 1414 reversibly coupled to the advancement pin 1410 and configured to apply torque to the advancement pin 1410. The delivery tool 1411 may facilitate (a) locking the wire 212 by rotating the tool 1414 in a first rotational direction to linearly advance the pin 1410 distally, pushing the ball 1412 and holding the ball 1412 in a pushing position in which the ball 1412 applies pressure to the wire 212, and (b) unlocking the wire 212 by rotating the tool 1414 in a second rotational direction to linearly advance the pin 1410 proximally such that the ball 1412 no longer applies pressure to the wire 212.

[0498] The use of ball 1412 reduces friction on wire 212, helping to prevent wire 212 from fraying over time.

[0499] In some applications, fastener 1402, with or without fastener 1460, can be used in combination with any one of contraction member covering devices 1082, 1092, 1102, 1202, 1302, 1802, 1822, and 1832 described above.

[0500] Specific examples of fasteners are described in various places herein, however, other fastening means, fasteners, clips, etc. may be used even if not specifically described in the examples herein.

[0501] For some applications, wire 212 has an outer diameter of 0.2 to 0.4 mm, e.g., 0.3 mm. First lumen 1405 has an outer diameter of 0.8 to 1.2 mm, e.g., 1.0 mm. Housing 1404 has an outer diameter of 2.8 to 3.2 mm, e.g., 3.0 mm, and a length of 3.3 to 3.7 mm, e.g., 3.5 mm.

[0502] For some applications, the locking ball 1412 advances from the second lumen 1403 within the first lumen 1405. The locking ball 1412 has an outer diameter of 1.0 to 1.1 mm, e.g., 1.05 mm, which is slightly larger than the diameter of the first lumen 1405 to help facilitate application of pressure by the ball 1412 to the wire 212 when compressed within the first lumen 1405.

[0503] Reference is now made to FIGS. 41A-41B, which are schematic illustrations of an example system 1500 including a locking mechanism including a fastener 1530 configured to be coupleable to a wire 212 (i.e., a contraction member) near a distal tissue anchor 1220 of the plurality of tissue anchors 220, according to some applications. The fastener 1530 is configured to restrict movement of the wire 212 relative to the plurality of tissue anchors 220 in its closed state (FIG. 41B). The fastener 1530 includes a housing 1532 shaped to define a lumen 1534 therethrough. The housing 1532 includes first and second housing subcomponents 1532a and 1532b that separate during delivery of the fastener 1530 to the implant 210 (FIG. 41A) and fit together during the closed state of the fastener 1530 (FIG. 41B).

[0504] The retraction member lock and cutter element 1550 is slidable within the lumen 1534 of the housing 1532. The retraction member lock and cutter element 1550 comprises first and second arms coupled together at their respective distal portions at the distal portion of the retraction member lock and cutter element 1550. The first and second arms of the elements 1550 are compressible toward each other such that the retraction member lock and cutter element 1550 assumes a closed state when the retraction member lock and cutter element 1550 is advanced within the lumen 1534 of the housing 1532 (FIG. 41B). The first and second arms are each shaped to define a respective cutting element 1552 at the proximal end of the first and second arms and a respective protrusion 1554 at an intermediate portion of the first and second arms. The protrusions 1554 are often rounded and project radially inward from the arms toward the central longitudinal axis of the housing 1532.

[0505] The pusher 1560 is shaped to push the retraction member lock and cutter element 1550 into the lumen 1534 of the housing 1532. The pusher 1560 includes a circular proximal pusher element 1561 that is engageable by the pusher tool 1540 of the delivery tool 1504 used to deliver the housing 1532. The round proximal pusher element 1561 of the pusher 1560 functions as the housing element 1532a. The round pusher element 1561 is coupled to a distally extending pusher post 1563 that is shaped to define a pusher bar 1562. The bar 1562 is removably coupled to the element 1550 and slides within the lumen 1534 to push the element 1550 within the lumen 1534. When element 1550 is disposed within lumen 1534, the arms are compressed by the walls defining lumen 1534 and pusher 1560 remains within lumen 1534, often due to frictional forces.

[0506] Prior to delivery of the fastener 1530, the wire 212 is threaded through an opening in the distal face of the housing 1530, through the lumen 1534 of the second housing component 1532b, through an opening defined by the distal portion of the contraction member lock and cutter element 1550, through an opening formed by the pusher bar 1562 of the pusher 1560, and through the opening 1536 in the first housing component 1532a, and into the fastener 1530.

[0507] When element 1550 is pushed into lumen 1534, the walls of lumen 1534 of housing 1532 push against the first and second arms of element 1550 such that they compress toward each other. In the closed state of retraction member lock and cutter element 1550 ( FIG. 41B ), (a) protrusions 1554 of retraction member lock and cutter element 1550 come together to facilitate locking of wire 212 by compressing wire 212 therebetween and restricting movement of the retraction member, and (b) cutting elements 1552 of retraction member lock and cutter element 1550 come together to cut wire 212. Because element 1550 remains within the patient, cutting element 1552 remains within the patient.

[0508] The housing 1532 of the fastener 1530 covers the free end 213 of the wire 212, so that the fastener 1530 functions as a contraction member covering device.

[0509] 42A-42B, which are schematic illustrations of a system 1600 including a locking mechanism including a fastener 1602 configured to be coupleable to a wire 212 (i.e., a contraction member) near a distal tissue anchor 1220 of the plurality of tissue anchors 220, according to some applications. The fastener 1602, in its closed state (FIG. 42B), is configured to restrict movement of the wire 212 relative to the plurality of tissue anchors 220. The fastener 1602 includes a housing 1604 including an inner wall shaped to form (a) a lumen for passage of the wire 212, (b) a distal conical surface 1605, and (c) a proximal portion 1603 of the inner wall that is threaded.

[0510] The fastener 1602 includes a threaded screw-in element 1606 having a threaded surface 1607 that is engageable with a threaded proximal portion 1603 of the inner wall of the housing 1604 .

[0511] Lock or wire lock 1610 is coupled to threaded screw element 1606 and is movable within the lumen of housing 1604 in response to threading of threaded screw element 1606. Wire lock 1610 includes first and second gripping elements 1611 and 1613 disposed on either side of wire 212. First and second gripping elements 1611 and 1613 each define a tapered surface 1615 and 1617 configured to (1) fit within distal conical surface 1605 of housing 1604 in response to distal threading of threaded screw element 1606 pushing contraction member lock 1610 distally, and thereby (2) compress wire 212 passing through first and second gripping elements 1611 and 1613.

[0512] Using the tool, fastener 1602 is delivered towards anchor 1220 and element 1606 is threaded longitudinally distally within the lumen of housing 1604 .

[0513] Prior to delivery of fastener 1602 , wire 212 is threaded through an opening in the distal face of housing 1602 , between gripping elements 1611 and 1613 of wire lock 1610 , and through threaded screw-in element 1606 .

[0514] In some applications, the housing 1604 of the fastener 1602 covers the free end of the wire 212, thereby functioning as a contraction member covering device.

[0515] In some applications, fastener 1602, with or without fastener 1460, can be used in combination with any one of constriction member covering devices 1082, 1092, 1102, 1202, 1302, 1802, 1822, and 1832 described above.

[0516] 43A-43B, which are schematic illustrations of a system 1700 including a locking mechanism including a fastener 1702 configured to be coupleable to a wire 212 (i.e., a contraction member) near a distal tissue anchor 1220 of the plurality of tissue anchors 220, according to some applications. In its closed state (FIG. 43B), the fastener 1702 is configured to restrict movement of the wire 212 relative to the plurality of tissue anchors 220. The fastener 1702 comprises a housing 1704 including an inner wall shaped to define a lumen for passage of the wire 212. The lumen is shaped in part to define a conical surface 1712 having a wide proximal portion and a narrow distal portion, the conical surface 1712 having a narrow surface at its distal end.

[0517] Housing 1704 includes a distal spring coupling element 1713, e.g., a washer, at the distal end of the lumen and a proximal spring coupling element 1714 at the proximal end of the lumen, disposed proximally relative to conical surface 1712. Longitudinal spring 1706 is coupled at each end to proximal and distal spring coupling elements 1714 and 1713, respectively. Spring 1706 includes a superelastic material, e.g., Nitinol, and includes a coiled distal subcomponent 1709 and a proximal cylindrical subcomponent 1707. Often, the proximal and distal subcomponents 1707 and 1709 of spring 1706 are fabricated from a single piece. The coiled element of distal subcomponent 1707 is shown in an expanded state in FIG. 43A and is configured to compress in a manner that draws proximal cylindrical subcomponent 1707 distally ( FIG. 43B ). The proximal subcomponent 1707 of the spring 1706 is coupled to at least one (e.g., three, as shown by way of example and not limitation) of the inwardly compressible elements 1708. As shown, the inwardly compressible elements 1708 include compressible spheres coupled to the spring 1706 at locations along the spring 1706 disposed within a space formed by a conical surface 1712. For some applications, the spring 1706 is shaped to define at least one slit or any suitable opening for inward movement of the inwardly compressible elements 1708. The inwardly compressible elements 1708 are disposed along the wire 212. In the open state of the fastener 1702 ( FIG. 43A ), the elements 1708 do not apply pressure to the wire 212, and the wire 212 slides freely relative to the fastener 1702.

[0518] The proximal spring coupling element 1714 includes a cylindrical element coupled to a distal washer. The element 1714 is movable distally within a space defined by the housing 1704 at its proximal portion. The washer of the proximal spring coupling element 1714 surrounds and is fixedly coupled to the proximal end of the spring 1706. In the open state of the fastener 1702 ( FIG. 43A ), the proximal spring coupling element 1714 is in a proximal position where the spring 1706 is pulled to a stretched state between the proximal and distal spring coupling elements 1714 and 1713, respectively, and the inwardly compressible element 1708 is disposed in the space defined by the wide portion of the conical surface 1712 and does not exert inward pressure on the wire 212. The proximal spring coupling element 1714 is held in this proximal position by a carrier 1720 that is reversibly coupled to the proximal spring coupling element 1714. The proximal spring coupling element 1714 defines a threaded surface 1716 that is engaged by a rotary tool 1722. When the tool 1722 remains coupled to the element 1714 and applies a proximal force to the element 1714, the proximal spring coupling element 1714 remains in a proximal position.

[0519] Once the anchor 220 is implanted in the tissue 10, the wire 212 is pulled to perform an annular formation on the valve. To maintain tension on the wire 212, the fastener 1702 is locked in place relative to the wire 212 by disengaging the tool 1720 from the fastener 1702. The rotation tool 1722 of the tool 1720 is rotated to loosen the tool 1720 from the housing 1704 of the fastener 1702. Upon unscrewing the rotation tool 1722, the tool 1720 no longer exerts a proximal force on the proximal spring coupling element 1714, and the spring 1706 can distally relax and compress, pulling the proximal spring coupling element 1714 distally, as shown in FIG. 43B , and the fastener 1702 assumes a closed state.

[0520] In the closed state of the fastener 1702, the proximal spring coupling element 1714 is in a distal position in which the inwardly compressible element 1708 is disposed in the narrow portion of the conical surface 1712 and the spring 1706 is in a relaxed state in which it exerts inward pressure on the wire 212 in response to pressure exerted on the element 1708 by the narrow surface of the conical surface 1712.

[0521] In some applications, the housing 1704 of the fastener 1702 covers the free end of the wire 212, thereby functioning as a contraction member covering device.

[0522] In some applications, fastener 1702, with or without fastener 1460, can be used in combination with any one of constriction member covering devices 1082, 1092, 1102, 1202, 1302, 1802, 1822, and 1832 described above.

[0523] 44A-44B, 45A-45B, and 46A-46B, which are schematic illustrations of systems 1800, 1820, and 1830, each including a respective contraction member covering device 1802, 1822, and 1832. Each of contraction member covering devices 1802, 1822, and 1832 includes a respective housing. Devices 1802 and 1822 include housing 1804, and device 1832 includes housing 1834.

[0524] Wire 212 passes longitudinally through each housing of devices 1802 , 1822 , and 1832 .

[0525] 44A-44B. Housing 1804 includes first and second flexible wires 1806 and 1808 that pass laterally through housing 1804 and along a portion of wire 212. Wires 1806 and 1808 comprise a superelastic material, such as Nitinol. In some applications, wires 1806 and 1808 are rectangular in cross section. Note that any number of flexible wires, e.g., three, can be used. First and second wires 1806 and 1808 are in a first position (FIG. 44A) in which first and second flexible wires 1806 and 1808 are not engaged with wire 212. As shown, in the first position, wires 1806 and 1808 are in a loaded configuration in which each of the first and second flexible wires assumes a curved configuration. 44A, at least a majority of first flexible wire 1806 is disposed above a portion of wire 212 and at least a majority of second flexible wire 1808 is disposed below a portion of wire 212. To maintain wires 1806 and 1808 in the first position, tube 1810 can be positioned between wire 212 and first and second flexible wires 1806 and 1808. Tube 1810 restricts transition of first and second flexible wires 1806 and 1808 to the second actuated position shown in FIG.

[0526] 44B , the tube 1810 is removed from within the housing 1804, allowing the first and second deflectable wires 1806 and 1808 to transition to a second actuated position in which the first and second wires 1806 and 1808 deflect to change the configuration of the portion of wire 212 in a manner that retracts an additional portion of wire 212 into the housing 1804. In the second position, the device 1802 is retracted into the housing 1804, covering the excess portion of wire 212 and the end 213 of wire 212 following severing of wire 212. In the second position, the first deflectable wire 1806 pushes down on the portion of wire 212 and the second deflectable wire 1808 pushes up on the portion of wire 212. In the second position, the first and second deflectable wires 1806 and 1808 assume a straight configuration. In the second position, first and second flexible wires 1806 and 1808 each have a length (measured along an axis transverse to the longitudinal axis of housing 1804) that is greater than the width of housing 1804. To accommodate the lengths of wires 1806 and 1808 in the second position of FIG. 44B , housing 1804 is shaped to define opening 1805. The respective ends of wires 1806 and 1808 protrude from housing 1804 through opening 1805.

[0527] 45A-45B. Housing 1804 includes first and second flexible wires 1826 and 1828 that pass laterally through housing 1804 and along a portion of wire 212. Wires 1826 and 1828 comprise a superelastic material, such as nitinol. In some applications, wires 1826 and 1828 are rectangular in cross section. Note that any number of flexible wires, e.g., three, can be used. First and second wires 1826 and 1828 are in a first position (FIG. 45A) in which first and second flexible wires 1826 and 1828 are not engaged with wire 212. As shown, in the first position, wires 1826 and 1828 are in a loaded configuration in which each of the first and second flexible wires assumes a curved configuration. 45A, at least a majority of first flexible wire 1826 is disposed above a portion of wire 212 and at least a majority of second flexible wire 1828 is disposed below a portion of wire 212. To maintain wires 1826 and 1828 in the first position, tube 1810 can be positioned between wire 212 and first and second flexible wires 1826 and 1828. Tube 1810 restricts transition of first and second flexible wires 1826 and 1828 to a second actuated position shown in FIG.

[0528] As shown in FIG. 45B , the tube 1810 is removed from within the housing 1804, allowing the first and second flexible wires 1826 and 1828 to transition to a second actuated position in which the first and second wires 1826 and 1828 deflect to assume a configuration that changes the configuration of the portion of the wire 212 in a manner that retracts an additional portion of the wire 212 into the housing 1804. In the second position, the device 1822 is retracted into the housing 1804 and covers the excess portion of the wire 212 and the end 213 of the wire 212 following severing of the wire 212. In the second position, the first flexible wire 1826 pushes down on the portion of the wire 212 and the second flexible wire 1828 pushes up on the portion of the wire 212. In the second position, the first and second flexible wires 1826 and 1828 assume a straight configuration. In the second position, first and second flexible wires 1826 and 1828 each have a length (measured along an axis transverse to the longitudinal axis of housing 1804) that is longer than the width of housing 1804. To accommodate wires 1826 and 1828 at their extended lengths in the second position of FIG. 45B , housing 1804 is shaped to define openings 1805. Ends of each of wires 1826 and 1828 protrude from housing 1804 through openings 1805. First and second flexible wires 1826 and 1828 each define at least one crimping region 1825 configured to shorten the length of first and second flexible wires 1826 and 1828 in the second position such that the ends of wires 1826 and 1828 do not protrude from within housing 1804.

[0529] 46A-46B. Housing 1834 includes first and second flexible wires 1836 and 1838 that pass laterally through housing 1834 and along a portion of wire 212. Wires 1836 and 1838 comprise a superelastic material, such as nitinol. For some applications, wires 1836 and 1838 are rectangular in cross section. Note that any number of flexible wires, e.g., three, can be used. First and second wires 1836 and 1838 are in a first position (FIG. 46A) in which first and second flexible wires 1836 and 1838 are not engaged with wire 212. As shown, in the first position, wires 1836 and 1838 are in a loaded configuration in which each of the first and second flexible wires assumes a curved configuration. 46A, a portion of first flexible wire 1836 is disposed above a portion of wire 212 and a portion of second flexible wire 1838 is disposed below a portion of wire 212. To maintain wires 1836 and 1838 in the first position, tube 1810 can be positioned between wire 212 and first and second flexible wires 1836 and 1838. Tube 1810 restricts transition of first and second flexible wires 1836 and 1838 to the second actuated position shown in FIG.

[0530] Wires 1836 and 1838 have a length (measured along an axis transverse to the longitudinal axis of housing 1834) that is less than the width of housing 1834.

[0531] 46B, the tube 1810 is removed from within the housing 1834, allowing the first and second flexible wires 1836 and 1838 to transition to a second actuated position in which the first and second wires 1836 and 1838 deflect to change the configuration of the portion of the wire 212 such that the first and second wires 1836 and 1838 push the wire 212 aside and retract an additional portion of the wire 212 into the housing 1834. In the second position, the device 1832 is retracted into the housing 1834 and covers the excess portion of the wire 212 and the end 213 of the wire 212 following severing of the wire 212. In the second position, the second flexible wire 1838 (for example) pushes the portion of the wire 212 upward. In the second position, the first and second flexible wires 1836 and 1838 assume a generally straight configuration.

[0532] 44A-44B, 45A-45B, and 46A-46B, it should be noted that the contraction member covering devices 1802, 1822, and 1832 may be used in combination with any of the fasteners 1402, 1460, 1530, 1602, and 1702 described herein, as well as any other suitable fastening means, fasteners, clips, etc.

[0533] 47A-47B, which are schematic illustrations of an embodiment of a tissue anchor 290, according to some applications. Anchor 290 includes a head, such as head 280, and a driver interface, such as driver interface 282. Anchor 290 also includes a tissue-engaging element 292, which may be a helical tissue-engaging element as shown and may be identical to or similar to tissue-engaging element 230 or other tissue-engaging elements described herein, except that tissue-engaging element 292 is made of a rod 294 shaped as a non-circular ellipse or any other shape having non-identical dimensions across two orthogonal axes of its cross-section. Tissue-e...

Claims

[Claim 1] 1. An apparatus for use with an anchor driver, the apparatus comprising: A wire, a first anchor and a second anchor, each of the first and second anchors comprising: a tissue engaging element defining a central longitudinal axis of the anchor, the tissue engaging element having a sharpened distal tip and configured to be delivered into tissue of a subject; a head coupled to a proximal end of the tissue engaging element, the head comprising: a driver interface configured to be reversibly engaged by the anchor driver; An eyelet, the wire defines an aperture therethrough; disposed laterally from the central longitudinal axis; the wire is shaped to allow smooth sliding of the eyelet on the wire along the sliding axis while being aligned with the sliding axis of the eyelet; an eyelet having an exterior shape that defines a tapered portion along the slide axis away from the aperture; A head comprising: a first anchor and a second anchor comprising: An apparatus comprising:

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