Patent Description:
Ischemic heart disease can cause atrioventricular valve regurgitation by, for example, the combination of ischemic dysfunction of the papillary muscles, and the dilatation of the ventricle associated with ischemic heart disease, with the subsequent displacement of the papillary muscles and/or the dilatation of the valve annulus.

Dilation of the annulus of an atrioventricular valve can prevent the valve leaflets from fully coapting when the valve is closed. Regurgitation of blood from the ventricle into the atrium can result in increased total stroke volume and decreased cardiac output, and ultimate weakening of the ventricle secondary to a volume overload and a pressure overload of the atrium.

Annuloplasty, such as by implantation of an annuloplasty ring, can be used to improve leaflet coaptation by adjusting the shape of the atrioventricular valve annulus. Percutaneous (e.g., transfemoral, transseptal, etc.) annuloplasty devices can be beneficial.

<CIT> discloses a system for reshaping the heart of subject, e.g. for treating dilatation of the annulus of a native valve. Said system comprises a contractable sleeve configured to be contracted by using a contraction element.

This summary is meant to provide some examples and is not intended to be limiting of the scope of the disclosure in any way. For example, any feature included in an example of this summary is not required by the claims, unless the claims explicitly recite the features. The description herein relates to systems, assemblies, methods, devices, apparatuses, combinations, etc. that can be used for reshaping the heart and/or a portion thereof. Various features and steps as described elsewhere in this disclosure can be included in the examples summarized here.

An adjustable annuloplasty structure, comprising a sleeve and a contracting member (e.g., a contraction wire, etc.), is contracted by tensioning the contracting member. In an exemplary application, the resulting excess of the contraction member is deposited within the lumen of the sleeve, obviating the need to remove the excess from the implant, e.g., by cutting. Contraction of the annuloplasty structure can therefore achieved by pulling the contraction member into and/or increasing a longitudinal proportion of the contraction member that is disposed within the lumen. The contraction can be maintained by locking a locking mechanism to the contraction member.

For some applications, the contraction member is pulled into the lumen from within the lumen.

There is therefore provided, in accordance with the present invention, a system and/or an apparatus for use at a heart of a subject, the system/apparatus including an annuloplasty structure that includes a flexible sleeve having a first sleeve-end-portion, a second sleeve-end-portion, and a circumferential wall that defines a longitudinal lumen between the first and second sleeve-end-portions. The annuloplasty structure also includes an elongate contraction member, such as a contraction wire. The contraction member/wire having a first end (e.g., a first wire-end) and a second end (e.g., a second wire-end). The first end or wire-end is attached to the sleeve at the first sleeve-end-portion, and the member/wire extending, in association with the circumferential wall, from the first sleeve-end-portion toward the second sleeve-end-portion.

The system/apparatus according to the invention, also includes a plurality of tissue anchors that are configured to anchor the sleeve to tissue. The plurality of tissue anchors include at least one second sleeve-end-portion tissue anchor configured to anchor the second sleeve-end-portion to tissue by being driven through the circumferential wall and into the tissue.

In some implementations, the system/apparatus also includes a force-distributing element configured to surround a second end portion or second wire-end portion of the member/wire that is disposed within the lumen of the sleeve and to distribute a force applied to the at least one second sleeve-end-portion tissue anchor during application of a contraction force to the elongate contraction member/wire.

According to the invention, the member/wire is arranged with respect to the sleeve such that increasing a longitudinal proportion of the member/wire that is disposed within the lumen longitudinally contracts the sleeve.

In an application, the force-distributing element includes a tube shaped so as to define a plurality of slits, and the plurality of slits increase flexibility of the force-distributing element.

In an application, the force-distributing element includes a flexible coil.

In an application, each tissue anchor of the plurality of tissue anchors is independently advanceable into the lumen of the sleeve and configured to anchor the sleeve to tissue by being driven through the circumferential wall and into the tissue.

In an application, the at least one second sleeve-end-portion tissue anchor are configured to anchor the second sleeve-end-portion at a portion of the second sleeve-end-portion containing the second end portion or second wire-end portion of the member/wire that is disposed within the lumen of the sleeve.

In an application, the member/wire extends from the first sleeve-end-portion to the second sleeve-end-portion in association with the circumferential wall, by weaving along the circumferential wall between the first sleeve-end-portion and the second sleeve-end-portion.

In an application, the second end portion or second wire-end portion of the member/wire enters the lumen of the sleeve such that it is disposed within the second sleeve-end-portion at an entry point, and the at least one second sleeve-end-portion tissue anchor is anchorable proximally to the entry point.

According to the invention, the second end or second wire-end is disposed within the lumen of the sleeve, and the member/wire is arranged with respect to the sleeve such that movement of the second end or second wire-end toward the second sleeve-end-portion increases the longitudinal proportion of the member/wire that is disposed within the lumen of the sleeve by drawing the member/wire into the lumen of the sleeve.

In an application, the system/apparatus further includes an anchor-delivery tool including an anchor-delivery channel and an anchor driver slidable within the anchor delivery channel.

In an application, the system/apparatus further includes coupling elements coupled to a distal end of the anchor-delivery tool, and the coupling elements are configured to ensnare a proximal end of the sleeve and have a tendency to flex inwardly toward a central longitudinal axis of the anchor-delivery tool in an absence of force applied thereto.

In an application, the channel is configured to (a) maintain coupling of the coupling elements to the sleeve by pushing against the coupling elements sleeve of the annuloplasty structure, and (b) facilitate decoupling of the anchor-delivery tool from the annuloplasty structure by being removed from the lumen of the sleeve and allowing the coupling elements to flex inwardly and become decoupled from the sleeve.

In an application:
each anchor of the plurality of tissue anchors:.

In an application, the system/apparatus further includes a contraction tool that includes a contraction member-engaging element or wire-engaging element, and the engaging element, subsequently to the anchoring of the sleeve using the plurality of tissue anchors:.

In an application, the system/apparatus further includes a loop coupled to the second end of the member or the second wire-end of the wire and disposed within the second sleeve-end-portion, and the loop surrounds an end portion of the channel that is advanceable within the lumen of the sleeve, and the channel is slidable with respect to the loop while the loop remains disposed within the second sleeve-end-portion, in order to facilitate implantation of the plurality of tissue anchors.

In an application, the snare is configured to ensnare the loop and to pull the loop into the lumen of the channel in order to facilitate application of a contraction force to the contraction member/wire, and the loop is compressible into the lumen of the channel as the snare pulls the loop and a portion of the contraction member/wire through the lumen of the channel.

In an application, the system/apparatus further includes a closure mechanism at the second sleeve-end-portion, the closure mechanism being maintainable in an opened state while the channel passes through the closure mechanism.

In an application, the channel is slidable with respect to the loop to and to the closure mechanism in order to facilitate implantation of the plurality of tissue anchors.

According to the invention, the system/apparatus further includes a contraction tool that includes a contraction member-engaging element or wire-engaging element, and the engaging element:.

In an application, the system/apparatus further includes a locking mechanism that has:.

In an application, the locking mechanism is positionable inside the lumen of the sleeve.

In an application, the system/apparatus further includes a contraction tool that includes a contraction member-engaging element or wire-engaging element, and:
the engaging element:.

In an application, the system/apparatus further includes a lock tool that engages the locking mechanism and is configured to transition the locking mechanism into the locked state.

In an application, the locking mechanism is biased to assume the locked state, the lock tool is configured to retain the locking mechanism in the unlocked state while the lock tool is engaged with the locking mechanism, and the lock tool is configured to transition the locking mechanism into the locked state by disengaging from the locking mechanism.

There is further provided, in accordance with some applications, a method, including using a delivery tool, securing an annuloplasty structure on an annulus of a valve of a subject. The annuloplasty structure can be the same as or similar to other annuloplasty structures herein or otherwise known. In some applications, for example, the annuloplasty structure includes (i) a flexible sleeve that defines a longitudinal lumen therethrough, and (ii) an elongate contraction member (e.g., a contraction wire, etc.).

The method further includes, subsequently, while the delivery tool is coupled to the annuloplasty structure, longitudinally contracting the sleeve. The sleeve can be contracted in a variety of ways. In some applications, the sleeve is contracted by increasing a longitudinal proportion of the contraction member/wire that is disposed within the lumen or causing the contraction member/wire to enter the lumen, e.g., by drawing the contraction member/wire into the lumen.

In an application, the delivery tool is coupled to the annuloplasty structure at a proximal end thereof, and longitudinally contracting includes longitudinally pulling the contraction member/wire proximally.

In an application, the sleeve includes a circumferential wall that defines the lumen, and securing the annuloplasty structure on the annulus includes sequentially, for each anchor of a plurality of anchors:.

In an application, the method further includes, subsequently to the step of longitudinally contracting the sleeve, maintaining a contraction state of the sleeve by locking a locking mechanism to the contraction member/wire.

In an application, locking the locking mechanism includes locking the locking mechanism while maintaining coupling of the delivery tool to the annuloplasty structure.

In an application, the method further includes, prior to the locking, delivering a force-distributing element within the lumen of the sleeve and facilitating distributing of contraction forces along the annuloplasty structure using the force-distributing element.

In an application, securing the annuloplasty structure includes implanting a plurality of tissue anchors, and delivering the force-distributing element includes distributing the contraction forces along a subset of the plurality of tissue anchors.

In an application, locking the locking mechanism includes locking in place the force-distributing element.

In an application, the contraction member/wire is coupled to a loop and the loop surrounds a portion of the delivery tool during the securing of the annuloplasty structure on the annulus.

In an application, longitudinally contracting includes:.

In an application, securing the annuloplasty structure on the annulus includes:.

In an application, advancing the portion of the delivery tool through the lumen of the sleeve includes moving the portion of the delivery tool with respect to the loop, while the loop remains stationary.

In an application, advancing the portion of the delivery tool through the lumen of the sleeve includes advancing the portion of the delivery tool distally through the lumen, and driving each one of the plurality of tissue anchors through the respective portions of the sleeve includes retracting the portion of the delivery tool proximally with each successive driving.

In an application, a portion of the delivery tool slides within the lumen of the sleeve, and the method further includes maintaining coupling of the delivery tool to annuloplasty structure by maintaining the portion of the delivery tool within the lumen.

In an application, maintaining the coupling of the delivery tool includes pushing outwardly coupling elements of the delivery tool that are coupled to the sleeve of the annuloplasty structure, and the method further includes decoupling the delivery tool from the annuloplasty structure by removing the portion of the delivery tool from within the lumen and allowing the coupling elements to flex inwardly and disengage from the sleeve of the annuloplasty structure.

In an application, maintaining the coupling of the delivery tool includes maintaining a closure mechanism of the annuloplasty structure in an open state by maintaining the portion of delivery tool within the lumen.

In an application, the method further includes decoupling the delivery tool from the annuloplasty structure by removing the portion of the delivery tool from within the lumen and transitioning the closure mechanism to a closed state.

This method can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, simulator (e.g. with the body parts, tissue, etc. being simulated), etc..

There is further provided, in accordance with some applications, a system and/or an apparatus for use at a heart of a subject, the system/apparatus including an annuloplasty structure that includes a flexible sleeve having a first sleeve-end-portion, a second sleeve-end-portion, and a circumferential wall that defines a longitudinal lumen between the first and second sleeve-end-portions. The annuloplasty structure also includes an elongate contraction member/wire having a first end (e.g., a first wire-end) and a second end (e.g., a second wire-end). The first end or first wire-end can be attached to the sleeve at the first sleeve-end-portion with the member/wire extending, in association with the circumferential wall, from the first sleeve-end-portion toward the second sleeve-end-portion.

In some applications, the system/apparatus also includes a plurality of tissue anchors configured to anchor the sleeve to tissue. The plurality of tissue anchors can include at least one second sleeve-end-portion tissue anchor configured to anchor the second sleeve-end-portion to tissue by being driven through the circumferential wall and into the tissue.

In some applications, the system/apparatus also includes an anchor-delivery tool including an anchor-delivery channel and an anchor driver slidable within the anchor delivery channel.

In some applications a loop is coupled to the second end of the member or the second wire-end of the wire and disposed within the second sleeve-end-portion. The loop can surround an end portion of the channel that is advanceable within the lumen of the sleeve, the channel being slidable with respect to the loop while the loop remains disposed within the second sleeve-end-portion, in order to facilitate implantation of the plurality of tissue anchors.

In some applications, the member/wire is arranged with respect to the sleeve such that increasing a longitudinal proportion of the member/wire that is disposed within the lumen, or causing the member/wire to enter the lumen, longitudinally contracts the sleeve.

Other features and components and steps described elsewhere herein can also be used with and/or added to the systems, apparatuses, and methods described above. And the methods herein can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, simulator (e.g. with the body parts, tissue, etc. being simulated), etc..

Reference is made to <FIG>, which are schematic illustrations of an example annuloplasty system <NUM> that comprises an implant <NUM>. System <NUM> is for treating a native valve <NUM> (e.g., an atrioventricular valve, such as the mitral valve or the tricuspid valve) of a heart <NUM> of a subject. Any and all of the methods, techniques, steps, etc. described herein using system <NUM> can be performed on a living animal or on a non-living cadaver, cadaver heart, simulator, anthropomorphic ghost, etc..

Implant <NUM> comprises an implant body <NUM>, which can be an annuloplasty structure, such as an annuloplasty band or an annuloplasty ring. Implant body <NUM> comprises a flexible sleeve <NUM>. Sleeve <NUM> has a first sleeve-end (i.e., a proximal end of sleeve <NUM>), a first sleeve-end-portion <NUM> (i.e., a proximal end portion of sleeve <NUM>), a second sleeve-end (i.e., a distal end of sleeve <NUM>), a second sleeve-end-portion <NUM> (i.e., a distal end portion of sleeve <NUM>), and a circumferential wall <NUM>. It is to be noted that in the context of the specification and claims the term "distal" refers to any part of systems described herein that is further from a point of entry into the body of the subject, and the term "proximal" refers to any part of systems described herein that is closer to a point of entry into the body of the subject.

Circumferential wall <NUM> defines a longitudinal lumen <NUM> between the first and second sleeve-ends. Circumferential wall <NUM> can be made of a fabric, such as a polyethylene terephthalate fabric, e.g., Dacron (TM). Implant <NUM> further comprises an elongate contraction member or contraction wire <NUM>. It is to be noted that the term "wire" is not intended to limit wire <NUM> to being metallic, nor to limit the number of strands that it may comprise. For some applications, the contraction member or contraction wire comprises one or more strands of metal. For some applications, the contraction member or contraction wire <NUM> comprises one or more strands of polymer. For some applications, contraction member or contraction wire <NUM> is braided or woven. For some applications, contraction member or contraction wire <NUM> is coated with a low-friction coating, such as polytetrafluoroethylene (PTFE).

Implant body <NUM> can be configured to be placed partially (e.g., <NUM>%, <NUM>%, <NUM>%, <NUM>%, <NUM>%, <NUM>-<NUM>%, etc.) or completely around an annulus of valve <NUM>. Implant body <NUM> can be attached to tissue (e.g., tissue of a heart valve annulus, etc.) in a variety of ways, such as with anchors, sutures, clips, and/or other attachment means. In some embodiments, the implant body <NUM> is configured to be anchored in place using a plurality of (e.g., <NUM>-<NUM>) tissue anchors <NUM>. In one embodiment, each tissue anchor comprises a tissue-coupling element <NUM>, and a tool-engaging head <NUM> fastened to an end of the tissue-coupling element. In some embodiments, following introduction of implant body <NUM> into the subject, each anchor <NUM> is sequentially (and typically independently) intracorporeally delivered into the lumen of the sleeve, and its tissue-coupling element <NUM> is driven through the circumferential wall and into tissue of the valve annulus, thereby anchoring the sleeve to the valve annulus. Subsequent to attachment to the tissue, longitudinal contraction of implant body <NUM> circumferentially tightens the valve annulus, thereby improving coaptation of the valve leaflets, and reducing regurgitation. Tissue anchors <NUM> can also be shaped differently, such as disclosed in <CIT> to Gross, which is known in the art.

For some applications, flexible sleeve <NUM> comprises a plurality of radiopaque markers <NUM>, which are positioned along the sleeve at respective longitudinal sites. The markers may provide an indication in a radiographic image (such as a fluoroscopy image) of how much of the sleeve has been deployed at any given point during an implantation procedure, in order to enable setting a desired distance between anchors <NUM> along the sleeve. For some applications, the markers comprise a radiopaque ink.

For some applications, the annuloplasty structure of implant body <NUM> is, or shares features with, mutatis mutandis, the annuloplasty structure(s) described in one or more of the following publications. For some applications, implant <NUM> is implanted as described in one or more of these publications, mutatis mutandis:.

Contraction member/wire <NUM> has a first end or a first wire-end <NUM> (i.e., a proximal end or a proximal wire-end <NUM>) and a second end or a second wire-end <NUM> (i.e., a distal end or a distal wire-end <NUM>). In some embodiments, first end or first wire-end <NUM> is attached (e.g., fixedly attached) to sleeve <NUM> at first sleeve-end-portion <NUM>, and member/wire <NUM> extends, in association with the circumferential wall of the sleeve, from the first sleeve-end-portion <NUM> to second sleeve-end-portion <NUM>. In some embodiments, and as shown, the association between member/wire <NUM> and circumferential wall <NUM> is provided by the member/wire being woven along or as part of the circumferential wall between first sleeve-end-portion <NUM> and second sleeve-end-portion <NUM>.

As shown, first and second sleeve-end-portions <NUM> and <NUM> can include more than just the very ends of sleeve <NUM>, i.e. the first and second sleeve-ends. Similarly, member/wire <NUM> may not extend all the way to the ends of sleeve <NUM>. As shown, at least one anchor <NUM> can be placed within at least one of first and second sleeve-end-portions <NUM> and <NUM>, beyond member/wire <NUM>. First end or first wire-end <NUM> being attached to sleeve <NUM> at first sleeve-end-portion <NUM> means that first end or first wire-end <NUM> is attached to sleeve <NUM> at an attachment point. First sleeve-end-portion <NUM> extends between the attachment point and the first sleeve-end. Member/wire <NUM> extends from the attachment point of first sleeve-end-portion <NUM> to an entry point of sleeve <NUM>. Second sleeve-end-portion <NUM> extends between the entry point and the second sleeve-end.

As described in more detail hereinbelow, member/wire <NUM> is arranged with respect to sleeve <NUM> such that pulling (e.g., proximal pulling from a location proximal to implant <NUM> in a proximal direction) a longitudinal proportion of the member/wire into the lumen (through the entry point at second sleeve-end-portion <NUM>) and/or increasing the amount that is disposed within the lumen longitudinally contracts the sleeve. Optionally, second end or second wire-end <NUM> of the member/wire <NUM> can be positioned inside the lumen.

<FIG> schematically shows implant <NUM> following its implantation at valve <NUM>, with the tissue-coupling element <NUM> of each anchor <NUM> extending through the circumferential wall of sleeve <NUM> and into the annulus of the valve. Tool-engaging head <NUM> is located within lumen <NUM> of sleeve <NUM>. For the sake of clarity, the tissue into which tissue-coupling elements <NUM> penetrate is not shown. As shown, second end or second wire-end <NUM> can be disposed within the lumen of sleeve <NUM> prior to and/or during implantation, or can be disposed outside the lumen but be pullable into the lumen. For some applications, and as shown, system <NUM> further comprises an elongate guide member <NUM>, reversibly coupled to second end or second wire-end <NUM>, and extending proximally though the lumen of sleeve <NUM>, and proximally away from implant <NUM> (e.g., out of the subject).

Following implantation of implant <NUM>, a contraction tool <NUM> is used to facilitate contraction of the implant. Contraction tool <NUM> comprises a contraction member-engaging element or wire-engaging element <NUM>, which is movable longitudinally into lumen <NUM> (e.g., over guide member <NUM>), and through the lumen to second end or second wire-end <NUM>. Such movement is shown in <FIG>. For applications in which implant body <NUM> is anchored using anchors <NUM>, tool <NUM> is dimensioned to be advanceable through lumen <NUM> past anchor heads <NUM> already disposed within the lumen.

Engaging element <NUM> is reversibly couplable, e.g., within lumen <NUM>, to second end or second wire-end <NUM>. Such coupling is shown in <FIG>. Implant <NUM> can comprise an appendage <NUM> coupled to second end or second wire-end <NUM> of contraction member/wire <NUM>. Engaging element <NUM> and appendage <NUM> are mutually configured to facilitate the reversible coupling of the engaging element to the second end or second wire-end of the contraction member/wire. While coupled to second end or second wire-end <NUM>, engaging element <NUM> is movable longitudinally toward first sleeve-end-portion <NUM> (e.g., by being pulled proximally), such that the second end or second wire-end <NUM> is moved toward the first sleeve-end-portion, thereby drawing contraction member/wire <NUM> into lumen <NUM>, and longitudinally contracting sleeve <NUM> (<FIG>).

System <NUM> further comprises a locking mechanism <NUM>, coupled to contraction tool <NUM>, and advanceable, using the contraction tool, longitudinally through lumen <NUM> (e.g., over guide member <NUM>) toward second sleeve-end-portion <NUM> and second end or second wire-end <NUM> of contraction member/wire <NUM> (e.g., as shown in <FIG>). In some embodiments, locking mechanism <NUM> has (i) an unlocked state in which the locking mechanism allows movement of contraction member/wire <NUM> through the locking mechanism, and increasing of the longitudinal proportion of the member/wire that is disposed within the lumen, and (ii) a locked state in which the locking mechanism inhibits movement of the member/wire through the locking mechanism.

Once a desired amount of contraction of sleeve <NUM> has been achieved by drawing contraction member/wire <NUM> into lumen <NUM> (and through locking mechanism <NUM>), locking mechanism <NUM> is locked, e.g., using tool <NUM>, which thereby also serves as a lock tool <NUM> that engages locking mechanism <NUM> within lumen <NUM>. The locking of locking mechanism <NUM> inhibits the contraction member/wire from moving back out of the lumen, and therefore maintains the desired amount of contraction of the sleeve. For example, locking mechanism <NUM>, locked to contraction member/wire <NUM>, may be too large to exit lumen <NUM> via the entry point or hole through which member/wire <NUM> entered the lumen at second sleeve-end-portion <NUM>. Though optionally, locking mechanism <NUM> can be configured to be attached to an inner wall of sleeve <NUM>.

Tool <NUM> can then be decoupled from member/wire <NUM> and removed from implant <NUM> (<FIG>). For applications in which system <NUM> comprises guide member <NUM>, the guide member is also decoupled from implant <NUM>, e.g., facilitated by tool <NUM>.

It is to be noted that the resulting excess <NUM> of member/wire <NUM> (i.e., the part of the member/wire that has passed through locking mechanism <NUM> and does not serve to maintain the contraction of sleeve <NUM>, e.g., the part of the member/wire that is not under tension) is disposed within lumen <NUM>. The inventors hypothesize that this, in contrast to a hypothetical similar implant in which the excess of the contraction member/wire is disposed outside of sleeve <NUM>, advantageously does not require removal of the excess of the contraction member/wire (e.g., by cutting).

Reference is now made to <FIG>, which are schematic illustrations of an annuloplasty system <NUM> for treating native valve <NUM>, in accordance with some applications. System <NUM> comprises an implantable annuloplasty structure <NUM>, which comprises implant body <NUM> (comprising flexible sleeve <NUM>) and contraction member/wire <NUM>, e.g., as described hereinabove, mutatis mutandis. Typically, except where noted, structure <NUM> and the implantation thereof are as described hereinabove for implant <NUM> and its implantation, mutatis mutandis.

As described for implant <NUM>, member/wire <NUM> of structure <NUM> can be arranged with respect to sleeve <NUM> such that pulling member/wire <NUM> into the lumen and/or increasing a longitudinal proportion of the member/wire that is disposed within the lumen longitudinally contracts the sleeve.

<FIG> show system <NUM> not comprising a guide member such as guide member <NUM>, described hereinabove. Optionally, in some embodiments, system <NUM> may in fact comprise a guide member, and/or system <NUM> may not comprise a guide member.

Contraction member/wire <NUM> has a first end or first wire-end <NUM> (i.e., a distal end or distal wire-end of member/wire <NUM>), and a second end or second wire-end <NUM> (i.e., a proximal end or proximal wire-end of member/wire <NUM>). In some embodiments, first end or first wire-end <NUM> is attached (e.g., fixedly attached) to sleeve <NUM> at first sleeve-end-portion <NUM> (i.e., a distal end portion of sleeve <NUM>), and member/wire <NUM> extends, in association with circumferential wall <NUM> of the sleeve, from the first sleeve-end-portion <NUM> toward second sleeve-end-portion <NUM> (i.e., a proximal end portion of sleeve <NUM>). First end or first wire-end <NUM> being attached to sleeve <NUM> at first sleeve-end-portion <NUM> means that first end or first wire-end <NUM> is attached to sleeve <NUM> at an attachment point. First sleeve-end-portion <NUM> extends between the attachment point and a first sleeve-end (i.e., a distal end of sleeve <NUM>). Member/wire <NUM> extends from the attachment point at first sleeve-end-portion <NUM> to an entry point <NUM> of sleeve <NUM>. Second sleeve-end-portion <NUM> extends between entry point <NUM> and a second sleeve-end (i.e., a proximal end of sleeve <NUM>). In some embodiments, and as shown, the association between member/wire <NUM> and circumferential wall <NUM> is provided by the member/wire being woven along or as part of the circumferential wall between first sleeve-end-portion <NUM> and second sleeve-end-portion <NUM>.

First end or first wire-end <NUM> is attached to sleeve <NUM> at the attachment point generally in a vicinity that is <NUM>-<NUM> from the first sleeve-end. That is, one or two anchors <NUM> are implanted between first end or first wire-end <NUM> and the first sleeve-end at first sleeve-end-portion <NUM>. In such a manner, the forces applied to contraction member/wire <NUM> are distributed between the anchors <NUM> at portion <NUM>. Member/wire <NUM> extends along body <NUM> until member/wire <NUM> enters lumen <NUM> of sleeve <NUM> at entry point <NUM> and a proximal end portion <NUM> of member/wire <NUM> is disposed within lumen <NUM> between entry point <NUM> and the second sleeve-end at second sleeve-end-portion <NUM>. Second end or second wire-end <NUM> of the member/wire <NUM> can be positioned inside the lumen. Second end or second wire-end <NUM> is provided with a loop <NUM>. In one embodiment, proximal end portion <NUM> of member/wire <NUM> forms a loop <NUM> and is secured to itself using a fastener <NUM>. In another embodiment, loop <NUM> is coupled to second end or second wire-end <NUM>. Entry point <NUM> is generally in a vicinity that is <NUM>-<NUM> from the second sleeve-end at second sleeve-end-portion <NUM>.

Anchors <NUM> are used to secure annuloplasty structure <NUM> to tissue of an annulus of a heart valve of the subject. System <NUM> is for treating a native valve (e.g., an atrioventricular valve, such as the mitral valve or the tricuspid valve) of the heart of the subject. Any and all of the methods, techniques, steps, etc. described herein using system <NUM> can be performed on a living animal or on a non-living cadaver, cadaver heart, simulator, anthropomorphic ghost, etc..

As shown, first and second sleeve-end-portions <NUM> and <NUM> can include more than just the very ends of sleeve <NUM>, i.e., the first and second sleeve-ends. Similarly, member/wire <NUM> may not extend all the way to the ends of sleeve <NUM>. As shown, at least one anchor <NUM> can be placed within at least one of first and second sleeve-end-portions <NUM> and <NUM>, beyond member/wire <NUM>.

As described in more detail hereinbelow, member/wire <NUM> is arranged with respect to sleeve <NUM> such that pulling (e.g., proximal pulling from a location proximal to structure <NUM> in a proximal direction) a longitudinal proportion of the member/wire into the lumen and/or increasing the amount that is disposed within the lumen longitudinally contracts the sleeve.

System <NUM> comprises an implant-structure-delivery tool <NUM> and an anchor-delivery tool comprising an anchor driver <NUM> and a channel or tube <NUM> (e.g., an anchor-delivery channel, anchor-delivery tube, etc.) which houses anchor driver <NUM> (<FIG>). Anchor driver <NUM> is slidable within tube/channel <NUM>. For some applications, implant-structure-delivery tool <NUM> comprises the anchor-delivery tool and a reference-force tube <NUM>. Though optionally, implant-structure-delivery tool <NUM> and the anchor-delivery tool can be separate devices which can be delivered, introduced and manipulated independently. A distal end <NUM> of anchor-delivery tube/channel <NUM> can be introduced into and disposed within lumen <NUM> of sleeve <NUM> of structure <NUM>. Tube/channel <NUM> can slide through and with respect to loop <NUM> in order to facilitate delivery of anchors <NUM>. As shown, the distal end <NUM> of anchor-delivery tube/channel <NUM> begins closest to first sleeve-end-portion <NUM> and deploys a first anchor <NUM> through wall <NUM> of sleeve <NUM>. As each subsequent anchor <NUM> is delivered, anchor-delivery tube <NUM> is retracted proximally toward second sleeve-end-portion <NUM> by sliding with respect to loop <NUM> while loop <NUM> remains in place and generally stationary. Techniques for implanting structure <NUM> and anchoring structure <NUM> to tissue using anchors <NUM> may be practiced in combinations with techniques as described in <CIT>.

A force is applied to the second sleeve-end-portion <NUM> by a distal end of reference-force tube <NUM> of implant-delivery tool <NUM> used to deliver structure <NUM>. As shown, anchor-delivery tube <NUM> is advanceable within a lumen of reference-force tube <NUM> and through lumen <NUM> of sleeve <NUM> such that a portion of anchor-delivery tube <NUM> that is disposed within the sleeve is coaxial with the sleeve. Distal end <NUM> of anchor-delivery tube <NUM> is disposed in contact with an inner wall of sleeve <NUM> at a distal end thereof. Additionally, a distal end portion of anchor-delivery tube <NUM> may comprise one or more radiopaque markers. As shown, anchor-delivery tube <NUM> and sleeve <NUM> are longitudinally and coaxially disposed with respect to each other.

In some embodiments, structure <NUM> comprises a closure mechanism <NUM> at second sleeve-end-portion <NUM> for closing an opening at second sleeve-end-portion portion <NUM> of sleeve <NUM>. Optionally, second sleeve-end-portion <NUM> may be left open when structure <NUM> is implanted, or may be closed as described in <CIT>. Closure mechanism <NUM> is coupled to sleeve <NUM> such as by being sutured to sleeve <NUM> using one or more sutures. Closure mechanism <NUM> comprises a flap <NUM> (e.g., a door) that has an open state and a closed state (e.g., as shown in <FIG>), and is configured to be biased toward assuming the closed state, such as described in <CIT>. When flap <NUM> is in the closed state, the lumen of sleeve <NUM> is in reduced communication with outside of the sleeve compared to when the flap is in the open state. In some applications, closure mechanism comprises a frame <NUM> to which flap <NUM> is articulatably coupled at an articulation point, and flap <NUM> is elastically biased toward assuming the closed state, e.g., by the frame, the articulation point, and the flap comprising a continuous piece of shape-memory material such as nitinol. In some applications, frame <NUM> is generally cylindrical, which reinforces the proximal end of sleeve <NUM>. For some applications, closure mechanism <NUM> comprises (e.g., is coated with) an anti-thrombotic agent.

When a portion of anchor-delivery tube <NUM> is disposed within lumen <NUM> of sleeve <NUM>, flap <NUM> is held in the open state. Anchor-delivery tube <NUM> thereby provides a working channel between outside the body of the subject, and lumen <NUM> of sleeve <NUM>, such as for delivery of anchors <NUM>, as described hereinabove. When anchor-delivery tube <NUM> is removed from lumen <NUM> (e.g., slid out of a proximal opening of the sleeve), flap <NUM> automatically moves toward the closed state.

Sleeve <NUM> can be reversibly couplable to reference-force tube <NUM> via one or more coupling elements <NUM> (e.g., sleeve-coupling elements) which are coupled to a distal end of the reference-force tube, such as described in <CIT>. Each coupling element <NUM> is shaped to define a distal projection, which is configured to be disposed within a respective negative space, such as a recess or a hole (not shown) in frame <NUM>, thereby coupling the coupling element to closure mechanism <NUM>, and thereby to sleeve <NUM>. Frame <NUM> can be generally cylindrical, and the hole can be defined in a lateral portion of the cylindrical shape. Coupling elements <NUM> can be configured to have a natural tendency (e.g., to be biased) to flex inwardly toward a central longitudinal axis of tube <NUM>.

That is, when anchor-delivery tube <NUM> is slid through lumen <NUM> in order to anchor tissue anchors <NUM> to tissue of the subject, anchor-delivery tube <NUM> (<NUM>) slides with respect to loop <NUM>, (<NUM>) slides with respect to frame <NUM> of closure mechanism <NUM> in order to maintain flap <NUM> in an open state, and (<NUM>) maintains coupling of implant-delivery tool <NUM> comprising tube <NUM>.

When coupling elements <NUM> are coupled to closure mechanism <NUM> and distal end <NUM> of anchor-delivery tube <NUM> is disposed within lumen <NUM> of sleeve <NUM> and distal to closure mechanism <NUM>, anchor-delivery tube <NUM> inhibits the coupling elements from decoupling from frame <NUM> of closure mechanism <NUM>. When distal end <NUM> of anchor-delivery tube <NUM> is slid proximally past closure mechanism <NUM> (and proximally past coupling elements <NUM>), the coupling elements automatically decouple from frame <NUM> of closure mechanism <NUM> by flexing inwardly toward the central longitudinal axis of tube <NUM>, thereby allowing tube <NUM> to become decoupled from sleeve <NUM>. Reference-force tube <NUM> may then be withdrawn proximally from sleeve <NUM>.

Thereby, in some applications, system <NUM> facilitates:.

Techniques for using anchor-delivery tube <NUM> and closure mechanism <NUM> can be practiced in combinations with techniques as described in <CIT>.

<FIG> schematically shows structure <NUM> following its initial implantation at the mitral valve, in which the first three tissue anchors <NUM> are used to anchor structure <NUM> to the tissue of the annulus. Tissue-coupling element <NUM> of each anchor <NUM> extends through circumferential wall <NUM> of sleeve <NUM> and into the annulus of the valve while tool-engaging head <NUM> of each anchor <NUM> is located (remains) within the lumen <NUM> of structure <NUM>. For the sake of clarity, the tissue into which tissue-coupling elements <NUM> penetrate is not shown.

In some embodiments, as shown, second end or second wire-end <NUM> is disposed within the lumen of sleeve <NUM> prior to and/or during implantation.

Anchor-delivery tube <NUM> is used to facilitate delivery of anchor <NUM>. After each anchor <NUM> is delivered, anchor-delivery tube <NUM> is retracted proximally, i.e., toward second sleeve-end-portion <NUM> of sleeve <NUM>. During implantation of anchors <NUM>, loop <NUM> surrounds a portion of anchor-delivery tube <NUM>. As each subsequent anchor <NUM> is delivered, anchor-delivery tube <NUM> is retracted toward second sleeve-end-portion <NUM> by sliding with respect to loop <NUM> while loop <NUM> remains in place and generally stationary. Anchors <NUM> are implanted using techniques described, for example, with reference to Figs. 10A-I of <CIT>.

<FIG> shows structure <NUM> following implantation thereof. A plurality of anchors <NUM> is used to anchor structure <NUM> to the tissue. It is to be noted that the plurality of tissue anchors <NUM> comprises at least one second sleeve-end-portion tissue anchor <NUM>, e.g., two anchors <NUM> as shown. It is to be noted that any suitable number of second sleeve-end-portion tissue anchors <NUM> can be implanted, e.g., between <NUM> and <NUM> by way of illustration and not limitation. In some implementations, second sleeve-end-portion tissue anchors <NUM> are implanted between entry point <NUM> of contraction member/wire <NUM> and the second sleeve-end at second sleeve-end-portion <NUM>. That is, anchors <NUM> are implanted in a vicinity of proximal end portion <NUM> of member/wire <NUM>. As is described herein below, second sleeve-end-portion tissue anchors <NUM> help distribute forces between anchors <NUM> from entry point <NUM> toward the second sleeve-end at second sleeve-end-portion <NUM>.

Reference is now made to <FIG>. Following implantation of structure <NUM>, a contraction tool is used to facilitate contraction of the implant. The contraction tool passes through anchor-delivery tube <NUM> and comprises an outer tube <NUM>, an inner tube <NUM> slidably disposed within outer tube <NUM>, and an engaging element or wire-engaging element <NUM> slidably disposed within inner tube <NUM>. The contraction tool is movable longitudinally into lumen <NUM>, and through lumen <NUM> of sleeve <NUM> toward second end or second wire-end <NUM> provided with loop <NUM>. In <FIG>, loop <NUM> no longer surrounds anchor-delivery tube <NUM> because anchor-delivery tube <NUM> has been retracted toward reference-force tube <NUM> in order to free loop <NUM> from around anchor-delivery tube <NUM>. That is, distal end <NUM> of anchor-delivery tube <NUM> is disposed proximally to loop <NUM>. Distal end <NUM> of anchor-delivery tube <NUM> is still within lumen <NUM> of sleeve <NUM> and anchor-delivery tube <NUM> at this stage still remains within the opening at second sleeve-end-portion <NUM> such that an external wall of anchor-delivery tube <NUM> retains closure mechanism <NUM> in an opened state.

Engaging element <NUM> comprises an elongate member, such as a wire, rod, line, suture, tube, a flat Nitinol wire, etc., and, in some implementations, has a distal end portion folded proximally so as to form a curved portion. Worded differently, engaging element <NUM> can be folded onto itself to define a hairpin-shaped segment defining a U-shaped bend. In some implementations, the pre-shaped distal end portion of engaging element <NUM> is biased to assume a closed configuration. The curved portion can be shaped so that the distal end of engaging element <NUM> flexes inwardly toward a longitudinal axis of inner tube <NUM>. In some implementations, the curved portion is contiguous with a distal portion of engagement element <NUM> located proximal (in the direction of extension of engaging element <NUM>) the distal end of engaging element <NUM>. In the closed configuration, the distal end of engaging element <NUM> can be biased toward the distal portion of engaging element <NUM>. Thus, in some implementations, in the closed configuration, the distal end of engaging element <NUM> is radially closer to the distal portion of engaging element <NUM> (or to inner tube <NUM>) than in the open configuration.

<FIG> shows the contraction tool transitioning from a delivery configuration, in which the distal end portion of engaging element <NUM> is in its closed configuration, to a gripping configuration shown in <FIG>. With further reference to <FIG>, when the contraction tool is in the delivery configuration, the distal end of engaging element <NUM> is disposed within a lumen of outer tube <NUM>. In particular, a distal end of inner tube <NUM> is positioned proximal the curved portion and the distal end of engaging element <NUM> is positioned radially between outer tube <NUM> and inner tube <NUM>.

<FIG> shows the pre-shaped distal end portion of engaging element <NUM> fully exposed from within a lumen of outer tube <NUM>. In some implementations, in the gripping configuration of the contraction tool shown in <FIG>, outer tube <NUM> is positioned proximal the distal end of engaging element <NUM> and inner tube <NUM> extends into the curved portion (i.e., the U-shaped bend) of the distal end portion of engaging element <NUM> so as to force the distal end of engaging element <NUM> to flex outwardly and thereby move the distal end portion of engaging element <NUM> into the open configuration. In some implementations, in the open position of the distal end portion of engaging element <NUM>, a distance between the distal end of engaging element <NUM> and an outer surface of inner tube <NUM> is enough to grip loop <NUM> so as to facilitate coupling between contraction tool <NUM> and loop <NUM>. When inner tube <NUM> is retracted proximally so as to no longer engage the curved portion, the distal end portion of engaging element <NUM> moves back into the closed configuration. Outer tube <NUM> can then be advanced distally to cover at least the distal end of engaging element <NUM>, as shown in <FIG>.

While coupled to second end or second wire-end <NUM>, i.e., by ensnaring loop <NUM> when the distal end portion of engaging element <NUM> assumes its closed configuration, the contraction tool is movable longitudinally toward the opening at the second sleeve-end <NUM> (i.e., by being pulled proximally), such that the second end or second wire-end <NUM> is moved toward the second sleeve-end, thereby drawing additional portions of contraction member/wire <NUM> into lumen <NUM> through entry point <NUM>, and longitudinally contracting sleeve <NUM> initially (<FIG>). Distal end <NUM> of anchor-delivery tube <NUM> is still within lumen <NUM> of sleeve <NUM> and anchor-delivery tube <NUM> at this stage still remains within the opening at second sleeve-end-portion <NUM> such that an external wall of anchor-delivery tube <NUM> retains closure mechanism <NUM> in an opened state. It is to be noted that the majority of contraction occurs subsequently to this initial step shown in <FIG>, as is described hereinbelow with reference to <FIG>.

Loop <NUM> comprises a super-elastic and flexible material, e.g., nitinol. Pulling on loop <NUM> when the distal end portion of engagement element <NUM> is in the closed configuration pulls loop <NUM> toward distal end <NUM> of anchor-delivery tube <NUM>. Loop <NUM> is compressed and constrained by the wall of anchor-delivery tube <NUM> as it is pulled within the lumen of anchor-delivery tube <NUM> so as to draw a portion of contraction member/wire <NUM> within the lumen of anchor-delivery tube <NUM>.

Reference is now made to <FIG>. System <NUM> comprises a force-distributing-element- and lock-delivering-tool <NUM> which is advanceable within the lumen of anchor-delivery tube <NUM> and over the contraction tool. Tool <NUM> is configured to deliver a force-distributing element <NUM>. Force-distributing element <NUM> can be coupled to a distal end of tool <NUM>. Though in some implementations, force-distributing element <NUM> can be positioned distal to tool <NUM> and pushed through anchor-delivery tube <NUM> by tool <NUM>. Further, optionally, force-distributing element <NUM> can be slidable with respect to and out of a lumen of a distal end of tool <NUM>, such as by means of a pusher tube (not shown) slidably disposed within tool <NUM>. Force-distributing element <NUM> is configured to surround proximal end portion <NUM> of contraction member/wire <NUM>. Tool <NUM> and force-distributing element <NUM> slide around the contraction tool. Once tool <NUM> and force-distributing element <NUM> slide beyond the distal end of the contraction tool, tool <NUM> and force-distributing element <NUM> slide directly along a portion of contraction member/wire <NUM>, including portion <NUM>, that is now disposed within a lumen of anchor-delivery tube <NUM>.

Force-distributing element <NUM> comprises a flexible structure having a lumen which surrounds contraction member/wire <NUM> at proximal end portion <NUM>. For some applications, force-distributing element <NUM> comprises a tubular element having a plurality of slits to increase flexibility of element <NUM>. For some applications, force-distributing element <NUM> comprises a coiled element. During placement of force-distributing element <NUM>, distal end <NUM> of anchor-delivery tube <NUM> is still within lumen <NUM> of sleeve <NUM> and anchor-delivery tube <NUM> at this stage still remains within the opening at second sleeve-end-portion <NUM> such that an external wall of anchor-delivery tube <NUM> retains closure mechanism <NUM> in an opened state.

Once force-distributing element <NUM> is fully deployed within lumen <NUM> of sleeve <NUM> (as shown in <FIG>), contraction of sleeve <NUM> is performed, e.g., by pulling on the contraction tool which pulls on loop <NUM> that is ensnared by the distal end portion of engagement element <NUM>, and by pushing against force-distributing element <NUM>, such as by means of tool <NUM> or, as mentioned above, a pusher tube or other. It is to be noted that "fully deployed" refers to a moment in which a distal end of element <NUM> reaches a distal end of portion <NUM> of member/wire <NUM> such that the distal end of element <NUM> reaches the inner surface of sleeve <NUM> at entry point <NUM>. <FIG> shows contraction of sleeve <NUM>. Contraction of structure <NUM> occurs from within lumen <NUM> as member/wire is being pulled, and also from within delivery tool <NUM> that houses anchor-delivery tube <NUM>, since contracting member/wire <NUM> is pulled within a lumen of anchor-delivery tube <NUM>.

During contraction, force-distributing element <NUM> distributes contraction forces between second sleeve-end-portion tissue anchors <NUM> from entry point <NUM> toward the second sleeve-end. That is, contraction is restricted to the portion of implant body <NUM> that is between entry point <NUM> of contraction member/wire and first end or first wire-end <NUM>. During contraction of sleeve <NUM>, distal end <NUM> of anchor-delivery tube <NUM> is still within lumen <NUM> of sleeve <NUM> and anchor-delivery tube <NUM> at this stage still remains within the opening at second sleeve-end-portion <NUM> such that an external wall of anchor-delivery tube <NUM> retains closure mechanism <NUM> in an opened state.

Once a desired amount of contraction of sleeve <NUM> has been achieved by drawing contraction member/wire <NUM> into lumen <NUM> and into the lumen of anchor-delivery tube <NUM>, tool <NUM> delivers toward a proximal end of element <NUM> a locking mechanism <NUM>, e.g., a lock, in an unlocked state, e.g., maintained in the unlocked state by lock tool <NUM>. Locking mechanism <NUM> is delivered around member/wire <NUM>. For some applications, force-distributing element <NUM> is delivered together with locking mechanism <NUM> in its unlocked state. Only once contraction of member/wire <NUM> has been achieved, locking mechanism <NUM> is transitioned to the locked state to lock member/wire <NUM> in place with respect to force-distributing element <NUM>, in order to maintain a contraction state of sleeve <NUM>.

Locking mechanism <NUM> has an unlocked state in which locking mechanism <NUM> allows movement of member/wire <NUM> through locking mechanism <NUM> and allows increasing of the longitudinal proportion of member/wire <NUM> that is disposed within lumen <NUM> of sleeve <NUM>. Locking mechanism <NUM> has a locked state in which locking mechanism <NUM> inhibits movement of member/wire <NUM> through locking mechanism <NUM>.

Locking mechanism <NUM> is locked, e.g., using lock tool <NUM>, such as by disengaging the lock tool from the locking mechanism. For some applications, locking mechanism <NUM> is biased to assume its locked state, and lock tool <NUM> is configured to retain the locking mechanism in its unlocked state while the lock tool is engaged with the locking mechanism. For such applications, disengagement of lock tool <NUM> from locking mechanism <NUM> allows the locking mechanism to transition into its locked state. Other locking mechanisms and lock tools described herein may also operate in this manner, mutatis mutandis. During the locking of member/wire <NUM>, distal end <NUM> of anchor-delivery tube <NUM> is still within lumen <NUM> of sleeve <NUM> and anchor-delivery tube <NUM> at this stage still remains within the opening at second sleeve-end-portion <NUM> such that an external wall of anchor-delivery tube <NUM> retains closure mechanism <NUM> in an opened state. Tool <NUM> can comprise a cutting element which can sever member/wire <NUM> once locking mechanism <NUM> is locked in place.

Locking mechanism or lock <NUM> locks in place contraction member/wire <NUM>. The contraction tool (e.g., engaging element <NUM> thereof) can then be decoupled from member/wire <NUM> and removed from structure <NUM> (<FIG>). The resulting excess of member/wire <NUM> is cut in order to avoid this loose portion of the member/wire from moving freely within the heart. In some embodiments, after contraction of structure <NUM>, excess member/wire <NUM> is removed. For example, the delivery tool <NUM> can comprise a cutter, or a dedicated cutter can be used - e.g., advanced over and along member/wire <NUM>. Optionally, excess member/wire <NUM> can be pushed back into lumen <NUM> of sleeve <NUM>, e.g. by means of the contraction tool or tool <NUM>, and can be enclosed within sleeve <NUM> in order to avoid this loose portion of member/wire <NUM> from moving freely within the heart.

Implant-delivery tool <NUM> (comprising reference-force tube <NUM> and channel/tube <NUM>, inter alia) is then decoupled from structure <NUM> by removing anchor-delivery tube <NUM> from within lumen <NUM> of sleeve <NUM> of structure <NUM>. Removing of anchor-delivery tube <NUM> from within lumen <NUM> enables closure mechanism <NUM> to assume its closed state. In the absence of anchor-delivery tube <NUM> within frame <NUM>, anchor-delivery tube <NUM> no longer pushes against coupling elements <NUM> and coupling elements <NUM> assume their natural tendency to flex inwardly toward the central longitudinal axis of tube <NUM>. As elements <NUM> flex inwardly, elements <NUM> are decoupled from frame <NUM> of structure <NUM> and tube <NUM> is disengaged from structure <NUM>. Additionally, anchor-delivery tube <NUM> no longer holds open flap <NUM>, if present, and flap <NUM> assumes the natural tendency toward the closed state. In such embodiments, flap <NUM> also prevents migration of locking mechanism <NUM> in an event in which locking mechanism <NUM> were to be decoupled from member/wire <NUM>. Thus, closure mechanism <NUM> retains locking mechanism <NUM> within lumen <NUM> of structure <NUM>.

Implant-delivery tool <NUM> (comprising reference-force tube <NUM>, anchor-delivery tube <NUM>, contraction tool <NUM>, force-distributing-element and lock-delivering tool <NUM>, inter alia) used to deliver structure <NUM>, and excess portions of member/wire <NUM> extending from loop <NUM> are extracted from the body of the subject. That is, system <NUM> advantageously provides a system in which implant-delivery tool <NUM>, remains coupled to structure <NUM> during contraction of structure <NUM> and during performing of the annuloplasty on the heart valve of the subject.

Reference is again made to <FIG>. It is to be noted that the pulling and contracting of contraction member/wire <NUM> occurs from second sleeve-end-portion <NUM>, i.e., from a proximal portion of structure <NUM> and the direction of the pulling and contraction is proximal. That is, contraction of structure <NUM> occurs at the proximal end of structure <NUM> and from within lumen <NUM> of structure <NUM> while implant-delivery tool <NUM> is coupled to structure <NUM>. Contraction is performed under the guidance of imaging and multiple contractions of member/wire <NUM> can be performed responsively to feedback, e.g., tactile, pressure gauge, and imaging.

Reference is again made to <FIG>. For some applications, the locking mechanism of a given system can be replaced with a one-way mechanism such as a ratchet, mutatis mutandis. The one-way mechanism can be coupled to the contraction member/wire, and to the sleeve at the second sleeve-end-portion, and can be configured to allow one-way movement of the member/wire through the one-way mechanism. The system would be arranged such that the one-way mechanism (i) allows increasing the longitudinal proportion of the member/wire that is disposed within the lumen, and (ii) inhibits reducing the longitudinal proportion of the member/wire that is disposed within the lumen.

Methods involving the systems and devices herein can include any of the steps described above, e.g., to implant, attach, contract, lock, etc. the systems, devices, components, etc. In some embodiments, methods involve transvascularly (e.g., transfemorally, etc.) advancing the system, device, implant, etc. to a target location, such as a heart valve annulus or simulation of a heart valve annulus. The methods involve attaching the system, device, implant, etc. to the target location (e.g., after advancement as described previously). Attaching can involve anchoring, suturing, clipping, and/or using other attachment means to attach the system, device, implant, etc. to the target location. The methods also involve contracting the system, device, implant, etc., which can be done by pulling or otherwise exerting force on a contraction member/wire (which can be attached, configured, and/or arranged as described in any of the embodiments above) to cause the system, device, implant, etc. to contract (e.g., to a contracted configuration with a smaller length, diameter, and/or radius of curvature). The contracting can be done as described with respect to any of the embodiments above. The methods can also include locking a locking mechanism, lock, locking device, etc. to hold the system, device, implant, etc. in the contracted configuration. The locking mechanism, lock, locking device, etc. can be the same and function and/or be operated in the same way as any of those described above.

Claim 1:
A system (<NUM>) for use at a heart of a subject, the system comprising an annuloplasty structure (<NUM>) that comprises:
a flexible sleeve (<NUM>) having a proximal sleeve-end, a distal sleeve-end, and a circumferential wall (<NUM>) that defines a longitudinal lumen (<NUM>) between the proximal and distal sleeve-ends;
an elongate contraction member (<NUM>) having a proximal end (<NUM>) and a distal end (<NUM>), wherein the proximal end (<NUM>) of the contraction member (<NUM>) is attached to the sleeve (<NUM>) at an attachment point of the sleeve (<NUM>), the attachment point and the proximal sleeve-end defining a proximal sleeve-end-portion (<NUM>), and a proximal end portion of the contraction member (<NUM>) extends, in association with the circumferential wall (<NUM>) of the sleeve (<NUM>), from the attachment point toward the distal sleeve-end and enters the lumen (<NUM>) of the sleeve (<NUM>) at an entry point of the sleeve (<NUM>) so that a distal end portion of the contraction member (<NUM>) is disposed within the lumen (<NUM>), the entry point and the distal end of the sleeve (<NUM>) defining a distal sleeve-end-portion (<NUM>); and
a plurality of tissue anchors (<NUM>) configured to extend through the circumferential wall (<NUM>) and into tissue to anchor the sleeve (<NUM>) to the tissue, wherein at least one tissue anchor (<NUM>) is placed within the distal sleeve-end-portion (<NUM>); and
a contraction tool (<NUM>) comprising an engaging element (<NUM>), wherein the engaging element (<NUM>) is configured to be moved longitudinally into and through the lumen (<NUM>) of the sleeve (<NUM>) toward the distal sleeve-end, and to be reversibly coupled to the distal end (<NUM>) of the contraction member (<NUM>), wherein when the engaging element (<NUM>) is reversibly coupled the distal end (<NUM>) of the contraction member (<NUM>), pulling the engaging element (<NUM>) proximally increases a length of the distal end portion of the contraction member (<NUM>) that is disposed within the lumen (<NUM>) so as to longitudinally contract the sleeve (<NUM>).