Patent Description:
Annuloplasty structures comprising a flexible material through which anchors are delivered tend to twist and warp as a result of passage of the anchor through the material of the annuloplasty structure. It is therefore often advantageous to provide devices and techniques to facilitate deployment of the tissue anchor through the flexible material of the annuloplasty structure while minimizing or eliminating twisting or warping of the flexible material during deployment of the anchor.

<CIT> describes devices and methods for securing a tissue anchor in tissue of a patient, in particular to ensure proper deployment of a cardiac tissue anchor by regulating the force or pressure of a deployment tool against the tissue; one way to ensure proper deployment force is to visualize the distal end of the tissue anchoring catheter from outside the body using a display for an imaging sensor, where the distal end of the catheter changes configuration when it is pressed against the tissue; another method involves automatically regulating the pressure applied to the tissue prior to deployment of the tissue anchor, which may also be used in conjunction with visualization; several safety locks to prevent deployment of the tissue anchor prior to establishment of the proper pressure are disclosed, which again may be used with visualization and/or an automated pressure regulator.

<CIT> describes a single fire tacker instrument is provided for installing a fastener through a prosthetic mesh and into tissue; the single fire tacker instrument includes a handle assembly and an elongated tacker assembly extending distally from the handle assembly; the elongated tacker assembly includes an inner tube for mounting the elongated tacker assembly to the handle assembly; the elongated tacker assembly includes a drive rod and a driver for rotating the fastener into tissue; a spring clip is provided about the driver to releasably retain the fastener on the driver; the elongated tacker assembly and additionally includes a spring biased outer tube mounted for movement relative to the handle assembly; the outer tube shields the fastener prior to insertion into tissue.

The present invention provides an apparatus for use with a tissue anchor according to independent claim <NUM>, and a method for implanting an implant along a simulation annulus of a simulation heart valve according to independent claim <NUM>. The depending claims are directed to respective further developments of the invention.

A tubular structure is used to advance toward a tissue site of a subject an anchor driver used to drive a tissue anchor into tissue of a subject. The tubular structure has a distal end portion comprising an implant-gripping element that is configured to temporarily grip material (e.g., flexible material) of an annuloplasty structure, in accordance with some applications of the present invention.

For some applications of the present invention, the implant-gripping element comprises a plurality of teeth which reversibly grip the material of the annuloplasty structure during deploying, or driving, a tissue anchor through material of the annuloplasty structure so as to anchor the annuloplasty structure to tissue of the subject.

According to the present invention, the implant-gripping element comprises a deformable element which changes its structural configuration as a tissue anchor is passed with respect to and engages the deformable element. This is advantageous because the tubular structure is able to move freely within a lumen of the annuloplasty structure and only engage and grip the annuloplasty structure once the desired location of tissue has been reached and it has been determined that in this location, a tissue anchor be driven into tissue.

There is therefore provided, in accordance with an application of the present invention, a system and/or apparatus, for use with a tissue anchor, the system/apparatus including an implant, dimensioned to be advanced into a body of a subject and an anchor-delivery tool. The anchor delivery tool includes an anchor-delivery channel, shaped to define a lumen therethrough, the lumen having a diameter, and the channel being dimensioned to be moveable within a lumen of the implant. The anchor-delivery tool also includes an implant-gripping element disposed at a distal end portion of the anchor-delivery channel. The implant-gripping element is configured to reversibly grip an inner wall of the implant during implantation of the tissue anchor via the anchor-delivery channel.

In an application, the implant-gripping element includes a radiopaque material.

In an application, the implant includes a flexible material, and the flexible material of the implant encases a distal portion of the channel.

In an application, the implant-gripping element includes a plurality of teeth which increase friction between the implant and the anchor-delivery channel.

In an application, the plurality of teeth are cut from a distal portion of a cylinder coupled to the distal end portion of the anchor-delivery channel.

In an application, a respective distal portion of each of the plurality of teeth are configured to grip the implant.

In an application, the implant includes a braided fabric, and the distal portions of the plurality of teeth are configured to reversibly ensnare the braided fabric.

According to the invention, the system/apparatus further includes the tissue anchor, and the tissue anchor includes:.

In an application, the tissue-engaging member includes a helical tissue-engaging member, and the implant-gripping element is configured to reversibly grip the implant and prevent twisting of the implant during corkscrewing of the helical tissue-engaging member with respect to the implant.

In an application, the system/apparatus further includes an anchor driver slidable through the lumen of the anchor-delivery channel, the anchor driver including:.

According to the invention, the implant-gripping element includes at least one deformable element configured to change shape from a resting state to a gripping state in response to passage of the tissue anchor alongside the deformable element.

In an application, the implant-gripping element includes a plurality of deformable elements disposed circumferentially with respect to the distal end portion of the anchor-delivery channel.

In an application, the deformable element is shaped so as to define an elongate tine having a straight portion and a curved portion in the resting state of the deformable element, and in the gripping state of the deformable element, the anchor is configured to radially push against the curved portion so as to straighten the curved portion and responsively, longitudinally lengthen the deformable element.

In an application, in the gripping state, a distal end of the deformable element extends beyond a distal end of the anchor-delivery channel.

In an application, the at least one deformable element includes a plurality of elongate tines, and the anchor is configured to radially push against the respective curved portions of the plurality of elongate tines.

In an application, the distal ends of the plurality of elongate tines are configured to increase surface area contact with the inner wall of the implant in the gripping state of the deformable element.

In an application, the at least one deformable element includes a plurality of lateral projections, and the anchor is configured to radially push against the plurality of lateral projections.

In an application, the plurality of lateral projections are configured to increase surface area contact with the inner wall of the implant in the gripping state of the deformable element.

There is further provided, in accordance with an application of the present invention, a method including positioning an implant along an annulus of a simulation heart valve of a subject. The implant is optimally dimensioned to be advanced into a body of the subject. The method can further include advancing an anchor-delivery tool with respect to the implant.

In some applications, the anchor-delivering tool includes an anchor-delivery channel, shaped to define a lumen therethrough, the lumen having a diameter. The channel can be dimensioned to be moveable within a lumen of the implant.

In some applications, the anchor-delivering tool includes an implant-gripping element disposed at a distal end portion of the anchor-delivery channel, the implant-gripping element being configured to reversibly grip a portion or wall of the implant (e.g., an inner wall of the implant, etc.) during implantation of the tissue anchor via the anchor-delivery channel.

The method can further include gripping a first portion of the implant using the implant-gripping element, and during the gripping of the first portion, anchoring the first portion of the implant to the annulus using a tissue anchor deliverable through the anchor-delivery channel.

In an application, the method further includes:.

In an application, the implant-gripping element includes a plurality of teeth, and gripping the first portion of the implant includes increasing friction between the first portion of the implant and the anchor-delivery channel.

In an application, the plurality of teeth are cut from a distal portion of a cylinder coupled to the distal end portion of the anchor-delivery channel, and gripping the first portion of the implant includes sandwiching the first portion of the implant between respective distal ends of the plurality of teeth and the annulus.

In an application, a respective distal portion of each of the plurality of teeth are configured to grip the implant, and gripping the first portion of the implant includes sandwiching the first portion of the implant between respective distal ends of the plurality of teeth and the annulus.

In an application, the implant includes a braided fabric, and gripping the first portion of the implant includes reversibly ensnaring the braided fabric by the plurality of teeth.

In an application, the method further includes sliding through the lumen of the anchor-delivery channel an anchor driver including:.

According to the invention, the implant-gripping element includes at least one deformable element configured to change shape from a resting state to a gripping state in response to passage of the tissue anchor alongside the deformable element, and the method further includes changing the shape of the deformable element by passing the tissue anchor alongside the deformable element.

In an application, the deformable element is shaped so as to define an elongate tine having a straight portion and a curved portion in the resting state of the deformable element, and passing the tissue anchor alongside the deformable element includes radially pushing the anchor against the curved portion, and by the pushing, straightening the curved portion and responsively, longitudinally lengthening the deformable element such that the deformable element assumes the gripping state.

In an application, in the gripping state, longitudinally lengthening the deformable element includes extending a distal end of the deformable element beyond a distal end of the anchor-delivery channel.

In an application, the at least one deformable element includes a plurality of elongate tines, and radially pushing the anchor includes radially pushing the anchor against the respective curved portions of the plurality of elongate tines.

In an application, gripping the first portion of the implant includes increasing surface area contact with the inner wall of the implant in the gripping state of the deformable element using the distal ends of the plurality of elongate tines.

In an application, the at least one deformable element includes a plurality of lateral projections, and pushing the anchor against the lateral projection includes radially pushing the anchor against the plurality of lateral projections.

In an application, radially pushing the anchor against the plurality of lateral projections includes increasing surface area contact with the inner wall of the implant in the gripping state of the deformable element.

The foregoing method(s) and other 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 now made to <FIG>, which is a schematic illustration of a system <NUM> providing one or more rotationally-controlled steering catheters configured for delivering an implant to a heart of a subject, in accordance with some applications of the present invention. <FIG> shows a distal portion of an implant that comprises an annuloplasty ring structure <NUM> (i.e., an implant, e.g., an annuloplasty band) comprising a flexible sleeve <NUM>. The implant is dimensioned to be advanced into a body of a subject. System <NUM> comprises an anchor-delivery tool comprising an implant-decoupling channel <NUM>. As described hereinbelow, channel <NUM> is used to facilitate delivery of tissue anchors through channel <NUM> and into a lumen of sleeve <NUM>. Thus, channel <NUM> functions as an anchor-delivery channel. Channel <NUM> is shaped so as to define a lumen having a diameter. Sleeve <NUM> comprises a flexible material which encases a distal portion of channel <NUM>. Channel <NUM> is dimensioned to be moveable within a lumen of the implant. An implant-gripping element <NUM> is disposed at a distal end portion of channel <NUM>. Implant-gripping element <NUM> is configured to reversibly grip an inner wall <NUM> of the implant during implantation of tissue anchor <NUM> via channel <NUM>.

Sleeve <NUM> typically comprises a braided fabric mesh, e.g., comprising polyethylene terephthalate (such as Dacron (TM)). Sleeve <NUM> can be configured to be placed only partially around a cardiac valve annulus (i.e., to assume a C-shape), and, once anchored in place, to be contracted so as to circumferentially tighten the valve annulus. Though optionally, the ring structure can also be configured to be placed entirely around the valve annulus.

Sleeve <NUM> has a tubular lateral wall <NUM> that (i) circumscribes a central longitudinal axis of the sleeve, and (ii) defines the lumen of the sleeve.

In order to tighten the annulus, annuloplasty ring structure <NUM> comprises a flexible elongated contraction member <NUM> that extends along sleeve <NUM>. Elongated contraction member <NUM> comprises a wire, a ribbon, a rope, or a band, which typically comprises a flexible and/or superelastic material, e.g., nitinol, polyester, stainless steel, or cobalt chrome. For some applications, the wire comprises a radiopaque material. For some applications, contraction member <NUM> comprises a braided polyester suture (e.g., Ticron). For some applications, contraction member <NUM> is coated with polytetrafluoroethylene (PTFE). For some applications, contraction member <NUM> comprises a plurality of wires that are intertwined to form a rope structure.

For some applications, annuloplasty ring structure <NUM> comprises an adjustment mechanism as described with reference to PCT application <CIT>, which published as <CIT>. The adjustment mechanism facilitates contracting and expanding of annuloplasty ring structure <NUM> so as to facilitate adjusting of a perimeter of the annulus and leaflets of the cardiac valve. The adjustment mechanism can comprise a rotatable structure (e.g., a spool).

System <NUM> can comprise a concentric arrangement of tubes defining an implant-delivery tool. System <NUM> can comprise a first, outer catheter <NUM> comprising a sheath configured for transluminal advancement through vasculature of a subject. For some applications of the present invention, outer catheter <NUM> comprises a sheath configured for advancement through a femoral artery toward an interatrial septum of a heart of a subject. A distal end portion <NUM> of outer catheter <NUM> is configured to pass through the transatrial septum of the subject, and to be oriented in a desired spatial orientation within the left atrium. System <NUM> comprises a second catheter, or guide catheter <NUM>, comprising a distal end portion <NUM> that is configured to pass through catheter <NUM> (i.e., a primary lumen thereof), to become disposed outside of a distal end of the outer catheter, and to be oriented in a desired spatial orientation within the left atrium.

Distal end portion <NUM> of outer catheter <NUM> is steerable. That is, distal end portion <NUM> is deflectable with respect to an immediately more proximal portion of catheter <NUM> (e.g., by using extracorporeal elements of system <NUM>). Distal end portion <NUM> of inner catheter <NUM> is steerable. That is, distal end portion <NUM> is deflectable with respect to an immediately more proximal portion of catheter <NUM> (e.g., by using extracorporeal elements of system <NUM>.

Guide catheter <NUM> is steerable to a desired spatial orientation in order to facilitate advancing and implantation of an implant in a body cavity of the subject.

For applications in which system <NUM> is used to deliver an implant to the mitral valve of the subject, often, outer catheter <NUM> is configured for initial advancement through vasculature of the subject until a distal end of catheter <NUM> is positioned in the left atrium. The distal steerable end portion of catheter <NUM> is then steered such that distal end of catheter <NUM> is positioned in a desired spatial orientation within the left atrium. The steering procedure can be performed with the aid of imaging, such as fluoroscopy, transesophageal echo, and/or echocardiography. Following the steering of the distal end portion of catheter <NUM>, guide catheter <NUM> (which houses annuloplasty ring structure <NUM>) is advanced through catheter <NUM> in order to facilitate delivery and implantation of structure <NUM> along the annulus of the mitral valve. During the delivery, at least a portion of steerable distal end portion <NUM> is exposed from the distal end of catheter <NUM> and is thus free for steering toward the annulus of the mitral valve, as is described hereinbelow.

During delivery of sleeve <NUM> to the annulus of the cardiac valve, sleeve <NUM> is disposed within a lumen of catheter <NUM> and can be aligned longitudinally with a longitudinal axis of catheter <NUM>.

In addition, in some applications, system <NUM> comprises a plurality of anchors <NUM>, typically between about <NUM> and about <NUM> anchors, such as about <NUM> or about <NUM> anchors. Each anchor <NUM> comprises a tissue-coupling element <NUM> (e.g., a helical tissue-coupling element), and a tool-engaging head <NUM> (e.g., a non-helically-shaped portion), or an anchor head, fixed to one end of the tissue-coupling element. Each tissue-coupling element <NUM> defines a respective tissue-engaging member. Each anchor <NUM> is deliverable to the target tissue site by a deployment element of an anchor driver <NUM> of an anchor deployment manipulator <NUM>. Driver <NUM> comprises (<NUM>) a longitudinal shaft having a flexible distal portion and a distal end, and (<NUM>) a deployment element coupled to the distal end of the shaft. The deployment element of driver <NUM> is reversibly couplable to tool-engaging head <NUM> of anchor <NUM>. When sleeve <NUM> is disposed along the annulus of the cardiac valve, deployment manipulator <NUM> is configured to advance within a lumen of sleeve <NUM> and deploy each anchor <NUM> from within sleeve <NUM> through a wall of sleeve <NUM> and into cardiac tissue, thereby anchoring sleeve <NUM> around a portion of the valve annulus.

Typically, but not necessarily, anchors <NUM> comprise a biocompatible material such as stainless steel <NUM> LVM. For some applications, anchors <NUM> comprise nitinol. For some applications, anchors <NUM> are coated fully or partially with a non-conductive material.

Deployment manipulator <NUM> comprises anchor driver <NUM> and the deployment element. For some applications, deployment manipulator <NUM> comprises an implant-decoupling channel <NUM>. As described hereinbelow, channel <NUM> is used to facilitate delivery of tissue anchors through channel <NUM> and into a lumen of sleeve <NUM>. Thus, channel <NUM> functions as an anchor-delivery channel.

Sleeve <NUM> is disposed within a lumen of guide catheter <NUM>. Implant-decoupling channel <NUM> is advanceable within a lumen of sleeve <NUM>. A distal end <NUM> of implant-decoupling channel <NUM> is placeable in contact with an inner wall of sleeve <NUM>, e.g., at a distal end thereof.

For some applications, channel <NUM> is steerable.

For some applications, manipulator <NUM> advances within channel <NUM>. For some applications, system <NUM> comprises a plurality of anchor drivers of manipulator <NUM>, each driver <NUM> being coupled to a respective anchor <NUM>. Each driver <NUM> is advanced within channel <NUM> in order to advance and implant anchor <NUM> in tissue. Following implantation of anchor <NUM>, anchor <NUM> is decoupled from driver <NUM>, as described herein, and driver <NUM> is removed from within channel <NUM>. A subsequent anchor <NUM> is then advanced within channel <NUM> while coupled to a driver <NUM> (e.g., a new driver).

As will be described hereinbelow, a first one of anchors <NUM> is configured to be deployed through an end wall, or an end, of sleeve <NUM> into cardiac tissue, when sleeve <NUM> is positioned along the annulus of the valve. Following the deployment of the first tissue anchor, a distal portion of sleeve <NUM> is slid distally off a portion of implant-decoupling channel <NUM>. In order to decouple sleeve <NUM> distally from a portion of outer surface of channel <NUM>, (<NUM>) a proximal force is applied to channel <NUM>, while (<NUM>) a reference-force tube (disposed proximally to sleeve <NUM>) is maintained in place in a manner in which a distal end of the reference-force tube provides a reference force to sleeve <NUM>, thereby facilitating freeing of a successive portion of sleeve <NUM> from around channel <NUM>. Channel <NUM> is then positioned at a successive location within the lumen of sleeve <NUM> while the reference-force tube and/or catheter <NUM> is steered toward a successive location along the annulus of the valve (as will be described hereinbelow). Consequently, the successive portion of sleeve <NUM> provides a free lumen for advancement of a successive anchor <NUM> and deployment of the anchor through the wall of the sleeve at the successive portion thereof. Such freeing of the successive portion of sleeve <NUM> creates a distance between successive anchors deployed from within the lumen of sleeve <NUM>.

For some applications, sleeve <NUM> comprises a plurality of radiopaque markers, which are positioned along the sleeve at respective longitudinal sites. The markers can 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, but other configurations are also possible.

As described hereinabove, implant-gripping element <NUM> is disposed at a distal end portion of channel <NUM>. For some applications, as shown, element <NUM> comprises a plurality of teeth <NUM> which extend beyond the distal end portion of channel <NUM> and beyond a distal end of the lumen defined by channel <NUM>. The plurality of teeth <NUM> are circumferentially disposed around a circumference of the distal end portion of channel <NUM>. For some applications of the present invention, each one of teeth <NUM> is jagged. The plurality of teeth <NUM> are configured to increase friction between channel <NUM> and the implant. Collectively, the plurality of teeth <NUM> form a series of peaks and valleys which increase surface area contact between channel <NUM> and inner wall <NUM> of sleeve <NUM>. For some applications of the present invention, teeth <NUM> are slanted. For some applications of the present invention, teeth <NUM> are rectangular. In either application, teeth <NUM> are configured to create increased surface area between the distal end of channel <NUM> and sleeve <NUM>. Additionally, teeth <NUM> are configured to reversibly grip sleeve <NUM> by pressing against sleeve <NUM>.

As shown, each one of teeth <NUM> is at a distal end of a respective elongate element <NUM> that is aligned with a longitudinal axis of the distal end portion of anchor-delivery channel <NUM>. Elongate elements <NUM> are spaced apart from one another such that the plurality of elongate elements <NUM> are configured to grip the portion of the implant. Collectively, the plurality of elongate elements <NUM> form a series of peaks and valleys which increase surface area contact between channel <NUM> and inner wall <NUM> of sleeve <NUM>. Elongate elements <NUM> increase surface area between the lateral surface of channel <NUM> and inner wall <NUM> of sleeve <NUM> while teeth <NUM> increase surface area between the distal opening of channel <NUM> and inner wall <NUM> of sleeve <NUM>. For some applications of the present invention, a respective distal portion of each of the plurality of teeth <NUM> are configured to grip the implant. That is, the implant comprises a braided fabric, and the distal portions of the plurality of teeth <NUM> are configured to reversibly ensnare the braided fabric.

For some applications of the present invention, teeth <NUM> and/or elongate elements <NUM> comprise radiopaque material.

The portion of sleeve <NUM> reversibly engaged and gripped by teeth <NUM> is the portion of sleeve <NUM> that is sandwiched between the distal end channel <NUM> (i.e., the distal ends of teeth <NUM>) and tissue. For some applications of the present invention, elongate elements <NUM> reversibly grip and engage lateral portions of sleeve <NUM> proximal to the portion of sleeve <NUM> that is sandwiched between the distal end channel <NUM> (i.e., the distal ends of teeth <NUM>) and tissue. That is, elongate elements <NUM> are spaced apart from each other creating a series of peaks and valleys which increase surface area so as to increase friction between elongate elements <NUM> and sleeve <NUM>.

For some applications of the present invention, the plurality of teeth <NUM> are cut from a distal portion of a cylinder coupled to the distal end portion of anchor-delivery channel <NUM>. For some applications of the present invention, the plurality of teeth <NUM> are cut from a distal portion of anchor-delivery channel <NUM>.

Prior to delivery of tissue anchor <NUM> into tissue of the subj ect, a portion of sleeve <NUM> is sandwiched between the distal end of channel <NUM> (i.e., the distal ends of teeth <NUM>) and the tissue. This is because a distal end of channel <NUM> contacts inner wall <NUM> of sleeve <NUM>. An anchor <NUM> is passed through a lumen of channel <NUM> and toward the target tissue site by a deployment element of anchor driver <NUM> of an anchor deployment manipulator <NUM>. During the driving of the tissue anchor through material of sleeve <NUM> and subsequently into the target tissue, implant-gripping element <NUM> grips the material of sleeve <NUM> to prevent or minimize distortion, movement, deformation, twisting, torsion, bunching, and any other relative movement of sleeve <NUM> with respect to tissue. For applications in which tissue-coupling element <NUM> of anchor <NUM> comprises a helical tissue coupling-element, implant-gripping element <NUM> prevents or minimizes twisting or torsion of sleeve <NUM> during the driving of anchor <NUM> through the material of sleeve <NUM>.

Once anchor <NUM> is delivered through sleeve <NUM>, teeth <NUM> and elongate elements <NUM> are decoupled from sleeve <NUM> (and thereby the grip on sleeve <NUM> by gripping element <NUM> is removed), by simply applying a pulling force to channel <NUM>. Since sleeve <NUM> is firmly anchored to tissue of the annulus by anchor <NUM>, a slight upward pulling force to channel <NUM> overcomes the reversible grip teeth <NUM> and elongate elements <NUM> temporarily have on sleeve <NUM>.

It is to be noted that the gripping and ungripping of gripping element <NUM> can occur repeatedly throughout the process of anchoring sleeve <NUM> to tissue of the annulus. For each anchor delivery, gripping element <NUM> grips sleeve <NUM> as each anchor <NUM> is deployed to anchor a given portion of the implant to the annulus, and once anchor <NUM> has been deployed, gripping element <NUM> is pulled proximally in order to reverse the gripping of sleeve <NUM> by gripping element <NUM>. Channel <NUM> is then moved to a different portion of the implant, and the gripping of sleeve <NUM> by gripping element <NUM> occurs once more as another anchor is deployed to anchor the different portion of the implant to the annulus.

Reference is now made to <FIG>, which are schematic illustrations of a system <NUM> comprising one or more rotationally-controlled steering catheters configured for delivering an implant to a heart of a subject, in accordance with some applications of the present invention. System <NUM> is similar to system <NUM> described hereinabove with reference to <FIG>, with the exception that implant-gripping element <NUM> comprises a deformable element <NUM> disposed within a housing <NUM>. For some applications of the present invention, housing <NUM> is tubular and is shaped so as to define a lumen therethrough. Housing <NUM> is coupled to a distal end portion of a tube of channel <NUM>. For some applications of the present invention, housing <NUM> defines the distal end portion of channel <NUM>. For some applications of the present invention, a distal end <NUM> of housing <NUM> defines the distal end of channel <NUM>. Deformable element <NUM> comprises a plurality of tines <NUM> disposed circumferentially with respect to an inner surface of housing <NUM>, i.e., with respect to a distal end portion of channel <NUM>. A proximal end of each tine <NUM> is coupled to a ring in order to couple together tines <NUM> and orient tines <NUM> circumferentially with respect to the distal end portion of channel <NUM>. For some applications of the present invention, tines <NUM> comprise radiopaque material.

Deformable element <NUM> has a resting state (as shown in <FIG>) and a gripping state (as shown in <FIG>). Each tine <NUM> comprises a curved portion <NUM> and a straight portion <NUM> and a gripper <NUM> (e.g., a tooth) at a distal end of the straight portion. In the resting state of deformable element <NUM>, curved portion <NUM> curves convexly toward and into the lumen of housing <NUM> such that the overall length of tine <NUM> is shortened. In the resting state of deformable element <NUM>, gripper <NUM> is disposed within housing <NUM> and does not extend beyond a distal end <NUM> of housing <NUM> (i.e., gripper <NUM> does not extend beyond a distal end of channel <NUM>). In the resting state, anchor <NUM> is disposed proximally to curved portions <NUM> of deformable element <NUM>.

<FIG> shows deformable element <NUM> in its gripping state. In the gripping state, anchor <NUM> is disposed within the lumen of housing <NUM> and radially, or laterally, pushes against curved portions <NUM> of tines <NUM> so as to change a structural configuration of deformable element <NUM> by straightening curved portions <NUM> and responsively, longitudinally lengthening the overall length of each tine <NUM> and thereby longitudinally lengthening deformable element <NUM>. Anchor <NUM> is disposed within the lumen of housing <NUM> and radially, or laterally, pushes against curved portions <NUM> in order to transition deformable element <NUM> from its resting state to its gripping state. In the gripping state, gripper <NUM> of each tine <NUM> is disposed distally to distal end <NUM> of housing <NUM>, and thereby distally to a distal end of channel <NUM>. In this state, gripper <NUM> is exposed from within housing <NUM> so that it is able to grip, press against, ensnare, or otherwise reversibly couple gripping element <NUM> to sleeve <NUM>. The plurality of elongate tines <NUM> are configured to increase surface area contact with inner wall <NUM> of the implant in the gripping state of deformable element <NUM>.

In the resting state of deformable element <NUM>, as shown in <FIG>, grippers are disposed within housing <NUM> such that they do not ensnare sleeve <NUM> during advancement of channel <NUM> with respect to sleeve <NUM>. Only once a tissue anchor <NUM> is passed through the distal end portion of channel <NUM>, and through housing <NUM>, as shown in <FIG>, deformable element <NUM> is engaged and grippers <NUM> are exposed.

<FIG> shows the steps involved in implanting two anchors <NUM> through material of sleeve <NUM>. In the first step, a first anchor <NUM> is passed through housing <NUM> in a manner in which anchor <NUM> pushes radially against curved portions <NUM> of tines <NUM> such that portion <NUM> are straightened and the overall length of tines <NUM> increases, as shown in <FIG>. In this step, the distal grippers <NUM> engage sleeve <NUM> by pushing sleeve <NUM> slightly distally enough to engage sleeve <NUM> but not penetrate sleeve <NUM>. This distal pushing increases friction between channel <NUM> and the implant. The portion of sleeve <NUM> engaged and gripped by grippers <NUM> is the portion of sleeve <NUM> that is sandwiched between distal end <NUM> of housing <NUM> (i.e., the distal end of channel <NUM>) and tissue. Surface area between grippers <NUM> and sleeve <NUM> increases. As shown in the first step, housing <NUM> defines a plurality of inner grooves <NUM> which house a respective tine <NUM>. As anchor <NUM> is being driven through fabric of sleeve <NUM> from within the lumen of sleeve <NUM>, and into tissue of the subject, grippers <NUM> of deformable element <NUM> of anchor-gripping element <NUM> reversibly grip and hold in place sleeve <NUM> in order to prevent or minimize distortion, movement, deformation, twisting, torsion, bunching, and any other relative movement of sleeve <NUM> with respect to tissue. For applications in which tissue-coupling element <NUM> of anchor <NUM> comprises a helical tissue coupling-element, implant-gripping element <NUM> prevents or minimizes twisting or torsion of sleeve <NUM> during the driving of anchor <NUM> through the material of sleeve <NUM>.

In the second step of <FIG>, anchor <NUM> has been driven fully into tissue. Once anchor <NUM> is driven into tissue, the radial force against curved portions <NUM> is absent, and curved portions <NUM> each return to their resting state of a curved shape, as shown in <FIG>, and the overall length of tine <NUM> decreases. Decreasing the length of tine <NUM> retracts grippers <NUM> into housing <NUM> such that they no longer contact sleeve <NUM>. Since sleeve <NUM> is firmly anchored to tissue of the annulus, this slight upward movement of tines <NUM> overcomes the reversible grip grippers <NUM> temporarily have on sleeve <NUM>.

It is to be noted that the radial force on curved portions <NUM> may be provided by tissue-coupling element <NUM> of anchor <NUM> and/or by tool-engaging head <NUM> of anchor, and/or by any part of anchor driver <NUM>. For such applications, radial force against curved portions <NUM> may be maintained only until anchor driver <NUM> and/or anchor <NUM> has been removed from within housing <NUM> (i.e., in a state in which housing <NUM> is empty, as shown in the third step of <FIG>).

In the third step of <FIG>, deformable element <NUM> is in its resting state awaiting the advancement through housing <NUM> of an additional anchor. In the resting state, grippers <NUM> are disposed within housing <NUM> and do not extend beyond distal end <NUM> of housing <NUM>, and thereby of channel <NUM>. Since grippers <NUM> do not extend beyond distal end <NUM>, deformable element <NUM> is in its resting state as shown in <FIG>, and implant-gripping element <NUM> does not engage sleeve <NUM>. This stage in which implant-gripping element <NUM> does not engage sleeve <NUM> enables channel <NUM> to move unobstructedly through the lumen of sleeve <NUM> without ensnaring or inadvertently gripping or engaging sleeve <NUM> from within the lumen of sleeve <NUM>. Thus, housing <NUM> and the overall structural configuration of deformable element <NUM> in its resting state enables such free movement of channel <NUM> within the lumen of sleeve <NUM>. This is advantageous because channel <NUM> is able to move freely within a lumen of sleeve <NUM> and only engage and grip sleeve <NUM> once the desired location of tissue has been reached and it has been determined that in this location, a tissue anchor <NUM> be driven into tissue.

It is to be noted that the gripping and ungripping of gripping element <NUM> occurs repeatedly throughout the process of anchoring sleeve <NUM> to tissue of the annulus. For each anchor delivery, gripping element <NUM> grips sleeve <NUM> as each anchor <NUM> is deployed to anchor a given portion of the implant to the annulus, and once anchor <NUM> has been deployed, gripping element <NUM> is pulled proximally in order to reverse the gripping of sleeve <NUM> by gripping element <NUM>. Channel <NUM> is then moved to a different portion of the implant, and the gripping of sleeve <NUM> by gripping element <NUM> occurs once more as another anchor is deployed to anchor the different portion of the implant to the annulus.

Reference is now made to <FIG>, which are schematic illustrations of a system <NUM> comprising one or more rotationally-controlled steering catheters configured for delivering an implant to a heart of a subject, in accordance with some applications of the present invention. System <NUM> is similar to system <NUM> described hereinabove with reference to <FIG>, with the exception that implant-gripping element <NUM> comprises a deformable element <NUM> of a housing <NUM>. System <NUM> is similar to system <NUM> described hereinabove with reference to <FIG>, with the exception that implant-gripping element <NUM> comprises a deformable element <NUM> comprising laterally-moveable lateral projections <NUM>. For some applications of the present invention, housing <NUM> is tubular and is shaped so as to define a lumen therethrough. Housing <NUM> is coupled to a distal end portion of a tube of channel <NUM>. For some applications of the present invention, housing <NUM> defines the distal end portion of channel <NUM>. For some applications of the present invention, a distal end <NUM> of housing <NUM> defines the distal end of channel <NUM>. Deformable element <NUM> comprises a plurality of laterally-moveable lateral projections <NUM> disposed circumferentially with respect to housing <NUM>, i.e., slightly proximally with respect to a distal end portion of channel <NUM>. For some applications of the present invention, projections are disposed at a middle section of housing <NUM>, by way of illustration and not limitation. In such a manner, projections <NUM> grip the lateral portions of sleeve <NUM> as sleeve <NUM> hugs channel <NUM> and/or housing <NUM>. The plurality of projections <NUM> are configured to increase surface area contact with inner wall <NUM> of the implant in the gripping state of deformable element <NUM>.

For some applications of the present invention, projections <NUM> comprise radiopaque material.

Deformable element <NUM> has a resting state (as shown in <FIG>) and a gripping state (as shown in <FIG>). Each laterally-moveable lateral projections <NUM> comprises a lateral-most portion <NUM>. In the resting state of deformable element <NUM>, lateral-most portion <NUM> is aligned with a lateral surface of housing <NUM>, i.e., with a lateral surface of channel <NUM>. In the resting state of deformable element <NUM>, portion <NUM> is disposed aligned with housing <NUM> and does not extend laterally beyond an external surface of housing <NUM>. For some applications of the present invention, an inwardly-facing portion of projection <NUM> is disposed within the lumen of housing <NUM>. In the resting state, anchor <NUM> is disposed proximally to projections <NUM> of deformable element <NUM>.

<FIG> shows deformable element <NUM> in its gripping state. In the gripping state, anchor <NUM> is disposed within the lumen of housing <NUM> and radially, or laterally, pushes against laterally-moveable lateral projections <NUM> so as to change a structural configuration of deformable element <NUM> by extending lateral-most portions <NUM> of projections <NUM> beyond the lateral surface of anchor-delivery channel <NUM>. As described hereinabove, an inwardly-facing portion of projection <NUM> is disposed within the lumen of housing <NUM> in a manner in which anchor <NUM> pushes against this inwardly-facing portion of projection <NUM> in order to outwardly push against projection <NUM> in order to transition deformable element <NUM> from its resting state to its gripping state. In the gripping state, lateral-most portions <NUM> of each projection <NUM> is disposed laterally with respect to housing <NUM>. In this state, projection <NUM> projects away from housing <NUM> so that it is able to grip, press against, ensnare, or otherwise reversibly couple gripping element <NUM> to sleeve <NUM>.

In the resting state of deformable element <NUM>, as shown in <FIG>, portions <NUM> are aligned with the surface of housing <NUM> such that they do not ensnare sleeve <NUM> during advancement of channel <NUM> with respect to sleeve <NUM>. Only once a tissue anchor <NUM> is passed through the distal end portion of channel <NUM>, and through housing <NUM>, as shown in <FIG>, deformable element <NUM> is engaged and projections <NUM> project beyond a lateral surface of housing <NUM>.

<FIG> shows the steps involved in implanting two anchors <NUM> through material of sleeve <NUM>. In the first step, a first anchor <NUM> is passed through housing <NUM> in a manner in which anchor <NUM> pushes radially against projections <NUM> of such that distal-most portions <NUM> project away from the external surface of housing <NUM>, as shown in <FIG>. In this step, the projections <NUM> engage sleeve <NUM> by pushing sleeve <NUM> slightly laterally enough to engage sleeve <NUM> but not penetrate sleeve <NUM>. This lateral pushing increases friction between channel <NUM> and the implant. Surface area between projections <NUM> and sleeve <NUM> increases. As anchor <NUM> is being driven through fabric of sleeve <NUM> from within the lumen of sleeve <NUM>, and into tissue of the subject, projections <NUM> of deformable element <NUM> of anchor-gripping element <NUM> reversibly grip and hold in place sleeve <NUM> in order to prevent or minimize distortion, movement, deformation, twisting, torsion, bunching, and any other relative movement of sleeve <NUM> with respect to tissue. For applications in which tissue-coupling element <NUM> of anchor <NUM> comprises a helical tissue coupling-element, implant-gripping element <NUM> prevents or minimizes twisting or torsion of sleeve <NUM> during the driving of anchor <NUM> through the material of sleeve <NUM>.

In the second step of <FIG>, anchor <NUM> has been driven fully into tissue. Once anchor <NUM> is driven into tissue, the radial force against projections <NUM> is absent, and projections <NUM> each return to their resting state by retracting laterally, as shown in <FIG>, and proximal-most portions <NUM> align with the external surface of housing <NUM>. Retracting projections <NUM> laterally moves lateral-most portions <NUM> inwardly radially such that they no longer contact sleeve <NUM>. Since sleeve <NUM> is firmly anchored to tissue of the annulus, this slight inward radial movement of projections <NUM> overcomes the reversible grip projections <NUM> temporarily have on sleeve <NUM>.

It is to be noted that the radial force on projections <NUM> can be provided by tissue-coupling element <NUM> of anchor <NUM> and/or by tool-engaging head <NUM> of anchor, and/or by any part of anchor driver <NUM>. For such applications, radial force against projections <NUM> may be maintained only until anchor driver <NUM> and/or anchor <NUM> has been removed from within housing <NUM> (i.e., in a state in which housing <NUM> is empty, as shown in the third step of <FIG>).

In the third step of <FIG>, deformable element <NUM> is in its resting state awaiting the advancement through housing <NUM> of an additional anchor. In the resting state, proximal-most portions <NUM> of projection <NUM> align with the external surface of housing <NUM> and do not extend beyond the lateral surface of housing <NUM>, and thereby of channel <NUM>. Portions <NUM> of projections <NUM> do not extend beyond the lateral surface of housing <NUM>, deformable element <NUM> is in its resting state as shown in <FIG>, and implant-gripping element <NUM> does not engage sleeve <NUM>. This stage in which implant-gripping element <NUM> does not engage sleeve <NUM> enables channel <NUM> to move unobstructedly through the lumen of sleeve <NUM> without ensnaring or inadvertently gripping or engaging sleeve <NUM> from within the lumen of sleeve <NUM>. Thus, housing <NUM> and the overall structural configuration of deformable element <NUM> in its resting state enables such free movement of channel <NUM> within the lumen of sleeve <NUM>. This is advantageous because channel <NUM> is able to move freely within a lumen of sleeve <NUM> and only engage and grip sleeve <NUM> once the desired location of tissue has been reached and it has been determined that in this location, a tissue anchor <NUM> be driven into tissue.

Reference is now made to <FIG>. For some applications, systems <NUM>, <NUM>, and <NUM> are used in combination with one or more techniques and or devices, systems, etc. described in one or more of the following references:.

Claim 1:
An apparatus, comprising:
an implant (<NUM>), dimensioned to be advanced into a body of a subject;
a tissue anchor (<NUM>), wherein the tissue anchor (<NUM>) comprises:
an anchor head (<NUM>), and
a tissue-engaging member (<NUM>), coupled to the anchor head (<NUM>), extending distally away from the anchor head (<NUM>) until a distal tip of the tissue-engaging member (<NUM>), and configured to anchor the anchor (<NUM>) to the tissue;
an anchor-delivery tool (<NUM>, <NUM>) comprising:
an anchor-delivery channel (<NUM>), shaped to define a lumen therethrough, the lumen having a diameter, and the channel (<NUM>) being dimensioned to be moveable within a lumen of the implant (<NUM>); and
an implant-gripping element (<NUM>) disposed at a distal end portion of the anchor-delivery channel (<NUM>), the implant-gripping element (<NUM>) being configured to reversibly grip an inner wall of the implant (<NUM>) during implantation of the tissue anchor (<NUM>) via the anchor-delivery channel (<NUM>);
characterized in that
the implant-gripping element (<NUM>) comprises at least one deformable element (<NUM>) configured to change shape from a resting state to a gripping state in response to passage of the tissue anchor (<NUM>) alongside the deformable element (<NUM>).