Patent Description:
The present disclosure relates to systems, apparatus and methods to repair operation of a heart valve, and more particularly repair the chordae tendineae of a human heart.

Myxomatous degeneration, mitral valve prolapse, bacterial endocarditis, and rheumatic heart disease are all examples of causes of chordae tendineae damage. When damaged or ruptured, the associated valve leaflet's function can become compromised, potentially allowing for regurgitation from ventricle to atrium. Surgical techniques exist in which chordae tendineae are replaced with PTFE sutures, but many of these techniques require atriotomy, and even those using a transcatheter approach are complicated by suture length adjustment and anchoring procedures. Proper suture length is critical for proper leaflet geometry, and anchoring is critical for fixation to the leaflet and heart wall.

From <CIT> an implant to be used in an abdominal cavity surgery or chest cavity surgery using an endoscope is known, the implant comprising a first implant member that includes at least one mechanical tissue fastener, a first implant member connector and a tether connecting the at least one mechanical tissue fastener and the first implant member connector, and a second implant member that includes a magnetic second implant member connector and wherein the first implant member connector and the second implant member connector are magnetically couplable. Another implant configured to control travel of a leaflet of a heart valve with magnetic implant members and a wire is known from <CIT>.

The present invention concerns an implant configured to control travel of a leaflet of a heart valve as defined in independent claim <NUM>.

The above-mentioned and other features of this disclosure, and the manner of attaining them, will become more apparent and better understood by reference to the following description of embodiments described herein taken in conjunction with the accompanying drawings, wherein:.

It may be appreciated that the present disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The invention herein may be capable of other embodiments and of being practiced or being carried out in various ways, and is limitted only by the appended claims Also, it may be appreciated that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting as such may be understood by one of skill in the art.

The systems, apparatus and methods to repair operation of a heart valve of the present disclosure simplify repair of chordae tendineae, particularly by separating the anchoring of a replacement (artificial) chordae tendineae into multiple steps, mechanically and procedurally, while allowing for subsequent adjustability of the length of the replacement (artificial) chordae tendineae after anchoring, which correspondingly controls travel of the heat valve leaflet.

According to the invention, an implant configured to control travel of a leaflet of a heart valve is provided, with the implant comprising a first implant member, the first implant member having a first implant member first fastener, a first implant member second fastener, a tether connecting the first implant member first fastener and the first implant member second fastener and a first implant member connector slidably disposed on the tether; a second implant member, the second implant member having a second implant member connector and a second implant member anchor; wherein the first implant member connector and the second implant member connector are magnetically couplable, and wherein at least one of the first implant member connector and the second implant member connector comprises a permanent magnet.

Referring now to <FIG>, there is shown a human heart <NUM>, which includes the left atrium <NUM> and the right atrium <NUM>, and the left ventricle <NUM> and the right ventricle <NUM>. The mitral valve <NUM>, also known as the bicuspid valve or left atrioventricular valve, is between the left atrium <NUM> and left ventricle <NUM>. The tricuspid valve <NUM>, also known as the right atrioventricular valve, is similarly located between the right atrium <NUM> and right ventricle <NUM>.

In a valve, such as the mitral valve <NUM>, the mitral valve leaflets <NUM> are connected to the papillary stalk <NUM> by the chordae tendineae <NUM>. Similarly, in the tricuspid valve <NUM>, the tricuspid valve leaflets <NUM> are connected to the papillary stalk <NUM> by the chordae tendineae <NUM>.

In certain instances, the native chordae tendineae <NUM>, such as of the mitral valve <NUM> or the tricuspid valve <NUM>, may tear, or otherwise function improperly between the mitral valve leaflets <NUM>/ tricuspid valve leaflets <NUM> and the papillary stalk <NUM>, and need to be repaired with an implanted replacement artificial (i.e. replacement for native) chordae tendineae <NUM>.

Referring now to <FIG>, an implant <NUM> according to the disclosure comprises a first implant member <NUM> and a second implant member <NUM>, which are configured to connect with one another to afford operation of the implant <NUM>.

As shown, first implant member <NUM> comprises a first mechanical tissue fastener <NUM> and a second mechanical tissue fastener <NUM>. First fastener <NUM> more particularly comprises a conical first fastener body <NUM> which narrows in diameter from a tissue retention (anchoring) end <NUM> to a tissue penetrating (pointed piercing) end <NUM>.

Similar to first fastener <NUM>, second fastener <NUM> comprises a conical second fastener body <NUM> which narrows in diameter from a tissue retention (anchoring) end <NUM> to a tissue penetrating (pointed piercing) end <NUM>. In addition, second fastener body <NUM> also comprises a centrally located through hole (bore) <NUM> which extends from the tissue retention (anchoring) end <NUM> to the tissue penetrating (pointed piercing) end <NUM>.

As such, first fastener <NUM> and second fastener <NUM> may be understood to be harpoon anchors.

First implant member <NUM> further comprises an elongated tether <NUM> which connects the first fastener <NUM> and the second fastener <NUM> and, more particularly, connects the first fastener body <NUM> and the second fastener body <NUM>. Tether <NUM> comprises an elongated filament <NUM>, which may have only one strand (i.e. mono-filament) or a plurality of strands (i.e. multi-filament) which may be, for example, fused, braided or otherwise bundled together. As shown, the elongated filament <NUM> extends through the through hole <NUM> of the second fastener body <NUM>.

Filament <NUM> may be formed of a natural material (e.g. silk suture, gut suture, catgut suture) or synthetic material (e.g. synthetic polymer).

Tether <NUM> also comprises a plurality of locking elements <NUM> spaced from one another along the longitudinal length of the elongated filament <NUM>. The position of the locking elements <NUM> is fixed on the elongated filament <NUM> such that the distance between the locking elements <NUM> relative to one another is also fixed. As explained below, the locking elements <NUM> adjustably fix the distance of the elongated filament <NUM> between the first fastener body <NUM> and the second fastener body <NUM>. As shown, the locking elements <NUM> are also spaced from each other at a longitudinal length of the elongated filament <NUM> which is substantially equal (e.g. within <NUM>) to a longitudinal length of the second fastener body <NUM>.

More particularly, the locking elements <NUM> have an outer diameter slightly larger than a diameter of the through hole <NUM> of the second fastener body <NUM>, and hence interfere with free movement of the elongated filament <NUM> in the through hole <NUM> of the second fastener body <NUM> due to an interference fit. Stated another way, due to locking elements <NUM> having an outer diameter slightly larger than a diameter of the through hole <NUM> of the second fastener body <NUM>, the locking element <NUM> adjacent the tissue penetrating end <NUM> of the second fastener body <NUM> will not freely enter the through hole <NUM> of the second fastener body <NUM>. In such manner, the longitudinal length of the elongated filament <NUM> between the first fastener <NUM> and the second fastener <NUM> is inhibited from increasing.

Similarly, due to locking elements <NUM> having an outer diameter slightly larger than a diameter of the through hole <NUM> of the second fastener body <NUM> (e.g. <NUM>-<NUM>% larger), the locking element <NUM> adjacent the tissue retention end <NUM> of the second fastener body <NUM> will not freely enter the through hole <NUM> of the second fastener body <NUM>. In such manner, the longitudinal length of the elongated filament <NUM> between the first fastener <NUM> and the second fastener <NUM> is inhibited from decreasing.

Given that the longitudinal length of the elongated filament <NUM> between the first fastener <NUM> and the second fastener <NUM> is inhibited from both increasing and decreasing, the longitudinal length of the elongated filament <NUM> between the first fastener <NUM> and the second fastener <NUM> may be understood to be fixed.

However, the locking elements <NUM> may be made of a resiliently (elastically) deformable material (e.g. a polymer, particularly an elastomer) which allows them to elastically deform under a load directed to force (pull) the elongated filament <NUM> through the through hole <NUM> of the second fastener body <NUM>.

In such case, the longitudinal length of the elongated filament <NUM> between the first fastener <NUM> and the second fastener <NUM> may be adjusted by the locking elements <NUM> traveling within the through hole <NUM> of the second fastener body <NUM>. In the foregoing manner, a longitudinal length of the elongated filament <NUM> between the first fastener <NUM> and the second fastener <NUM> is adjustably fixable.

First implant member <NUM> further comprises a first implant member connector <NUM> which is configured to join with and separate from (i.e. releasably join), second implant member connector <NUM> of second implant member <NUM>, as explained in greater detail below.

More particularly, first implant member connector <NUM> comprises a first implant member connector body <NUM> configured to releasably join with second implant member connector body <NUM> of second implant member connector <NUM>.

As shown, first implant member connector body <NUM> comprises a through hole (bore) <NUM>, through which filament <NUM> of tether <NUM> extends. The diameter of through hole <NUM> is great enough to enable first implant member connector body <NUM> to free slide along a length of filament <NUM>, as well as the locking elements <NUM>, without deforming them. As such the through hole <NUM> has a diameter slightly larger than the outer diameter of the locking elements <NUM> (e.g. <NUM>-<NUM>% larger).

First implant member connector body <NUM> preferably comprises a magnet, and more particularly comprises a permanent magnet (e.g. a ferrite magnet). Even more particularly, first implant member connector body <NUM> preferably comprises a rare-earth magnet, such as a neodymium magnet and/or a samarium-cobalt magnet. As used herein, a rare-earth magnet may be prepared from at least one rare-earth element, such as cerium (Ce), dysprosium (Dy), erbium (Er), europium (Eu), gadolinium (Gd), holmium (Ho), lanthanum (La), lutetium (Lu), neodymium (Nd), praseodymium (Pr), promethium (Pm), samarium (Sm), scandium (Sc), terbium (Tb), thulium (Tm), ytterbium (Yb), and yttrium (Y).

As such, the opposing sides <NUM> and <NUM> of first implant member connector body <NUM> may have opposite polarities, such as side <NUM> having a negative (-) polarity and side <NUM> having a positive (+) polarity.

Similarly, second implant member connector body <NUM> preferably comprises a magnet, and more particularly comprises a permanent magnet (e.g. a ferrite magnet). Even more particularly, second implant member connector body <NUM> preferably comprises a rare-earth magnet, such as a neodymium magnet and/or a samarium-cobalt magnet. As used herein, a rare-earth magnet may be prepared from at least one rare-earth element, such as cerium (Ce), dysprosium (Dy), erbium (Er), europium (Eu), gadolinium (Gd), holmium (Ho), lanthanum (La), lutetium (Lu), neodymium (Nd), praseodymium (Pr), promethium (Pm), samarium (Sm), scandium (Sc), terbium (Tb), thulium (Tm), ytterbium (Yb), and yttrium (Y).

Side <NUM> of second implant member connector body <NUM> may have a positive (+) polarity or a negative (-) polarity.

On the opposite side of side <NUM> of second implant member connector body <NUM>, second implant member <NUM> comprises a mechanical tissue anchor <NUM>. As shown, anchor <NUM> comprises a mechanically engaged (threaded) anchor having a helical thread.

Referring now to <FIG>, in certain embodiments, first implant member <NUM>, as well as second implant member <NUM>, may be delivered into the heart using an introducer/catheter <NUM>. As shown first implant member <NUM> may be contained within the lumen <NUM> of the introducer/catheter body <NUM>, in a manner such does not extend beyond the distal end <NUM> of the introducer/catheter body <NUM>, until such is ready to be implanted.

Referring now to <FIG>, during an implantation procedure, anchor <NUM> of second implant member <NUM> may be first anchored in the heart wall, particularly to papillary stalk <NUM> of the heart, which originate in the ventricular wall of the heart <NUM>. The second implant member <NUM> may be implanted internally via a trans-septal approach of the introducer/catheter <NUM>.

During implantation, the anchor <NUM> of second implant member <NUM> may be rotated such that the helical thread of anchor <NUM> engages and threads into the papillary stalk <NUM>. As shown, when second implant member <NUM> is anchored to the heart <NUM>, it is not connected to first implant member <NUM>.

After second implant member <NUM> is implanted, the first fastener <NUM> of first implant member <NUM> may be deployed from the introducer/catheter <NUM> such that the first fastener body <NUM> pierces a hole in leaflet <NUM> (or <NUM>) of mitral valve <NUM> (or tricuspid valve <NUM>) and extends through the hole. As shown the first fastener <NUM> is deployed such that the first fastener body <NUM> resides on the side of the leaflet <NUM> which faces the atrium <NUM> (or atrium <NUM>), with the tissue retention end <NUM> of the first fastener body <NUM> disposed on the side of the leaflet <NUM> which faces the atrium <NUM> (or atrium <NUM>). Alternatively, the leaflet <NUM> (or <NUM>) of mitral valve <NUM> (or tricuspid valve <NUM>) may be pierced with a separate needle or wire passed through the introducer/catheter <NUM>.

The first implant member <NUM> may then be further deployed such that tether <NUM> is unfolded, and first implant member connector <NUM> and second fastener <NUM> are removed from the introducer/catheter <NUM>.

As shown, the second fastener <NUM> of first implant member <NUM> may be deployed from the introducer/catheter <NUM> such that the second fastener body <NUM> pierces a second hole in the leaflet <NUM> (or <NUM>) of mitral valve <NUM> (or tricuspid valve <NUM>) and extends through the hole. As shown the second fastener <NUM> is deployed such that the second fastener body <NUM> resides on the side of the leaflet <NUM> which faces the atrium <NUM> (or atrium <NUM>), with the tissue retention end <NUM> of the second fastener body <NUM> disposed on the side of the leaflet <NUM> which faces the atrium <NUM> (or atrium <NUM>). Alternatively, the leaflet <NUM> (or <NUM>) of mitral valve <NUM> (or tricuspid valve <NUM>) may be pierced with a separate needle or wire passed through the introducer/catheter <NUM>.

As shown, in <FIG>, the first fastener <NUM> and second fastener <NUM> of the first implant member <NUM>, and the anchor <NUM> of the second implant member <NUM>, are fastened (anchored) in the leaflet <NUM> (or <NUM>) and to the papillary stalk <NUM>, respectively, prior to any connection of the first implant member <NUM> and second implant member <NUM> to one another.

Referring now to <FIG>, the first implant member connector <NUM> and second implant member connector <NUM> may then be coupled together. More particularly, the first implant member connector body <NUM> and second implant member connector body <NUM> may be magnetically coupled together, by virtue of one or both of the first implant member connector body <NUM> and the second implant member connector body <NUM> comprising a magnet, particularly a permanent magnet and more particularly a rare-earth permanent magnet.

If only one of the first implant member connector body <NUM> and the second implant member connector body <NUM> comprises the magnet, then the other connector body <NUM> or <NUM> may comprise a magnetic material, and more particularly a ferromagnetic material, which will couple magnetically with the magnet of the other connector body <NUM> or <NUM>. Exemplary magnetic materials include cobalt, hematite, iron, nickel, carbon steel and certain stainless steels, which include iron and have a crystal structure be arranged in a ferritic or a martensitic structure. Magnetic stainless steel may include ferritic stainless steel (e.g. grades <NUM>, <NUM> and <NUM>), martensitic stainless steel (e.g. grades <NUM>, <NUM> and <NUM>) or duplex stainless steel which contains a mixture of austenite and ferrite (e.g. grade <NUM>).

If both the first implant member connector body <NUM> and the second implant member connector body <NUM> comprises the magnet, then side <NUM> of first implant member connector body <NUM> and side <NUM> of second implant member connector body <NUM> may each provide a magnet which have opposite polarities (positive (+) and negative (-)) as to be magnetically attracted to one another when within a certain distance of one another. As shown in <FIG>, after the first fastener <NUM> and second fastener <NUM> of the first implant member <NUM>, and the anchor <NUM> of the second implant member <NUM>, are anchored in the leaflet <NUM> (or <NUM>) and to the papillary stalk <NUM>, respectively, but prior to the first implant member connector body <NUM> and the second implant member connector body <NUM> making physical contact with one another, the filament <NUM> of the tether <NUM> has a longitudinal length disposed between the first fastener <NUM> and the second fastener <NUM> which is long enough to permit the leaflet <NUM> (or <NUM>) to operate (i.e. open and close) unconstrained by the tether <NUM>.

Referring now to <FIG>, in contrast to <FIG>, the first implant member connector body <NUM> and the second implant member connector body <NUM> are now in physical contact with one another and magnetically coupled. As shown, while the filament <NUM> of the tether <NUM> is more taut than on <FIG>, the filament <NUM> of the tether <NUM> has a longitudinal length disposed between the first fastener <NUM> and the second fastener <NUM> which is long enough to permit the leaflet <NUM> (or <NUM>) to operate unconstrained by the tether <NUM>.

Referring to <FIG>, once the first implant member connector body <NUM> and the second implant member connector body <NUM> are in physical contact with one another, the longitudinal length of the filament <NUM> of the tether <NUM> disposed between the first fastener <NUM> and the second fastener <NUM> may be adjusted, by being decreased, as to constrain opening and closing movement of the leaflet <NUM> (or <NUM>).

More particularly, the filament <NUM> of the tether <NUM> may be pulled through the through hole <NUM> of the second fastener body <NUM>, particularly adjacent the tissue penetrating end <NUM> of the second fastener body <NUM>, such as by a grasping device <NUM> (e.g. forceps), to shorten, and thereby adjust, the longitudinal length of the filament <NUM> of the tether <NUM> disposed between the first fastener <NUM> and the second fastener <NUM>. In the foregoing manner, the opening and closing movement (travel) of the leaflet <NUM> (or <NUM>) may be decreased, as compared to prior to the implantation of the implant <NUM>, particularly by being inhibited by the length of the filament <NUM> of the tether <NUM> disposed between the first fastener <NUM> and the second fastener <NUM>.

As set forth above, tether <NUM> comprises a plurality of deformable locking elements <NUM> spaced from one another along the longitudinal length of the elongated filament <NUM>. The deformable locking elements <NUM> adjustably fix the distance of the elongated filament <NUM> between the first fastener body <NUM> and the second fastener body <NUM>.

As such, when the filament <NUM> of the tether <NUM> is pulled through the through hole <NUM> of the second fastener body <NUM> by a grasping device <NUM>, the longitudinally directed pulling force applied to the filament <NUM> via the grasping device <NUM> is significant enough to overcome the bias of the resilience of the locking elements <NUM>, in which case the locking element <NUM> adjacent the tissue retention end <NUM> of the second fastener body <NUM> deforms, which causes the locking element <NUM> to enter and travel within through hole <NUM> towards the tissue penetrating end <NUM> of the second fastener body <NUM>, thus shortening, the longitudinal length of the filament <NUM> of the tether <NUM> disposed between the first fastener <NUM> and the second fastener <NUM>. When the filament <NUM> of the tether <NUM> is pulled through the through hole <NUM> of the second fastener body <NUM> such that the locking element <NUM> within the through hole <NUM> exits the through hole <NUM> adjacent the tissue penetrating end <NUM> of the second fastener body <NUM>, the resilience (elasticity) of the locking element <NUM> may enable the locking element <NUM> to regain its undeformed state, and the longitudinal length of the filament <NUM> of the tether <NUM> disposed between the first fastener <NUM> and the second fastener <NUM> may be fixed in position once again.

For perhaps more fine tuning of the length of movement (travel) of the opening and closing movement of the leaflet <NUM> (or <NUM>) with the implant <NUM> of the present disclosure, the travel length of the leaflet <NUM> (or <NUM>) may also be adjusted by rotation of the second implant member connector body <NUM> (e.g. via forceps) of second implant member <NUM>, either further out of, or further into, the papillary stalk <NUM> while the first implant member connector body <NUM> is inhibited by rotating (e.g. via forceps). As such, the second implant member <NUM> may be adjustable axially by adjustable fixation depth. Thus, the implant <NUM> of the present disclosure provides multiple means to adjust the length of movement (travel) of the opening and closing movement of the leaflet <NUM> (or <NUM>) with the implant <NUM>.

Alternatively, the second fastener <NUM> of first implant member <NUM> may be anchored to the leaflet <NUM> (or <NUM>) of mitral valve <NUM> (or tricuspid valve <NUM>) after the first implant member connector <NUM> and second implant member connector <NUM> are magnetically coupled. <FIG> depicts another illustrative implant <NUM> according to the disclosure. The illustrative implant <NUM> includes a first implant member <NUM> configured to connect with a second implant member <NUM> (not depicted in <FIG>) to afford operation of the implant <NUM>.

Similar to the implant <NUM> depicted in <FIG>, the implant <NUM> depicted in <FIG> includes a conical-shaped first mechanical tissue fastener <NUM> and a conical-shaped second mechanical tissue fastener <NUM>. In embodiments, both the first mechanical tissue fastener <NUM> and second mechanical tissue fastener <NUM> may each be understood to include harpoon anchors.

In contrast to the implant <NUM> depicted in <FIG>, the implant <NUM> depicted in <FIG> includes an elongated tether <NUM> having a first portion 130a that passes through an through-hole <NUM> formed in the first mechanical tissue fastener <NUM> and a second portion 130b that passes through an through-hole <NUM> formed in the second mechanical tissue fastener <NUM>. Tether <NUM> includes an elongated filament <NUM>, which may have only one strand (i.e. mono-filament) or a plurality of strands (i.e. multi-filament) which may be, for example, fused, braided or otherwise bundled together. Filament <NUM> may be formed of a natural material (e.g. silk suture, gut suture, catgut suture) or synthetic material (e.g. synthetic polymer).

The first portion 130a of the elongated filament <NUM> and the second portion 130b of the elongated filament <NUM> each include a plurality of locking elements <NUM> spaced apart from one another along the longitudinal length of the first portion 130a of the elongated filament <NUM> and the second portion 130b of the elongated filament <NUM>, respectively. The position of the locking elements <NUM> along both the first portion 130a and the second portion 130b of the elongated filament <NUM> is fixed on the elongated filament <NUM> such that the distance between the locking elements <NUM> relative to one another is also fixed. Similar to the implant <NUM> depicted in <FIG>, the locking elements <NUM> adjustably fix the distance of the elongated filament <NUM> between the first fastener body <NUM> and the second fastener body <NUM>. As shown, the locking elements <NUM> are also spaced from each other at a longitudinal length of the elongated filament <NUM> which is substantially equal (e.g. within <NUM>) to a longitudinal length of the second fastener body <NUM>.

More particularly, the locking elements <NUM> have an outer diameter slightly larger than a diameter of the through-hole <NUM> in the first mechanical tissue fastener <NUM> and a diameter of the through-hole <NUM> in the second mechanical fastener <NUM>. The locking elements <NUM> thus interfere with free passage of the first portion 130a of the elongated filament <NUM> through the through-hole <NUM> in the first mechanical tissue fastener <NUM> and interfere with free passage of the second portion 130b of the elongated filament <NUM> through the through-hole <NUM> in the second mechanical tissue fastener <NUM>. In such manner, the longitudinal length of the elongated filament <NUM> between the first fastener <NUM> and the second fastener <NUM> is inhibited from increasing.

Similarly, due to locking elements <NUM> having an outer diameter slightly larger than a diameter of the through-hole <NUM> in the first mechanical tissue fastener <NUM> and a diameter of the through-hole <NUM> in the second mechanical fastener <NUM>, the locking elements <NUM> prevent the longitudinal length of the elongated filament <NUM> between the first fastener <NUM> and the second fastener <NUM> from decreasing. Given that the longitudinal length of the elongated filament <NUM> between the first fastener <NUM> and the second fastener <NUM> is inhibited from both increasing and decreasing, the longitudinal length of the elongated filament <NUM> between the first fastener <NUM> and the second fastener <NUM> may be understood to be fixed.

In embodiments, the locking elements <NUM> may include a resiliently (elastically) deformable material (e.g. a polymer, particularly an elastomer) that permits an elastic deformation elastically deform under a load directed to force (pull) the first portion 130a of the elongated filament <NUM> through the through-hole <NUM> in the first mechanical tissue fastener <NUM> and/or the second portion 130b of the elongated filament <NUM> through the through-hole <NUM> in the second mechanical tissue fastener <NUM>. In such embodiments, the longitudinal length of the elongated filament <NUM> between the first mechanical tissue fastener <NUM> and the second mechanical tissue fastener <NUM> may be adjusted by the locking elements <NUM> traveling within the through hole <NUM> of the second fastener body <NUM>. In the foregoing manner, a longitudinal length of the elongated filament <NUM> between the first mechanical tissue fastener <NUM> and the second mechanical tissue fastener <NUM> is adjustably fixable.

In another embodiment, as shown in <FIG>, the second implant member <NUM> may be anchored in the heart wall at the left ventricular apex <NUM> located at the bottom of the left ventricle <NUM> inferior to both the mitral valve <NUM> and aortic valve, particularly as part of an external (trans-apical) approach. Similar to the prior embodiments, second implant member <NUM> may be implanted before the first implant member <NUM>. The second implant member <NUM> may also comprise a tether <NUM>, similar to tether <NUM>, which couples between the second implant member connector body <NUM> and the anchor <NUM>. In such instance, the tether <NUM> may extend through the wall of the heart, and be attached to an anchor <NUM> which is disposed adjacent an outer side of the heart. The anchor <NUM> may comprise a pledget (e.g. expanded PTFE pledget) or similar button (planar disc or circular plate) anchoring device to secure the tether <NUM>.

<FIG> depicts yet another illustrative embodiment in which the second implant member <NUM> may be anchored in the heart wall at the left ventricular apex <NUM> located at the bottom of the left ventricle <NUM> inferior to both the mitral valve <NUM> and aortic valve, particularly as part of an external (trans-apical) approach. As depicted in <FIG>, in such embodiments, the first implant member <NUM> may include only a single first mechanical tissue fastener <NUM> coupled to the first implant member connector body <NUM> via only the first portion 130a of the elongated filament <NUM>. In such embodiments, the elongated filament <NUM> may pass over the mitral valve leaflet <NUM> and the first mechanical tissue fastener <NUM> may penetrate the mitral valve leaflet <NUM> from top to bottom. Such an arrangement beneficially permits placement of the second implant member <NUM> in the heart wall and the penetration of the mitral valve leaflet <NUM> from above, simplifying the implantation of both the first implant member <NUM> and the second implant member <NUM>. The length of the elongated filament <NUM> may be adjusted by passing the locking elements <NUM> through the through-hole <NUM> in the first mechanical tissue fastener <NUM> to achieve a desired length of the elongated filament <NUM>.

<FIG> depicts another illustrative second implant member <NUM> that includes a shape memory alloy anchor <NUM> that includes a central receiver portion <NUM> to receive the tissue anchor <NUM> portion of the second implant member <NUM> and additionally includes a plurality of shape memory alloy hook members 510A-510n (collectively "shape memory alloy hook members <NUM>," six such shape memory alloy hook members 510A-510F are depicted in <FIG>).

As depicted in <FIG>, the second implant member <NUM> may be deployed using a catheter - in such a deployment, the shape memory alloy hook members <NUM> extend longitudinally from the central receiver portion <NUM>. Upon exiting the catheter, the shape memory alloy hook members <NUM> curve upward to assume the "fishhook" or "grappling hook" configuration depicted in <FIG>. The curvature of the shape memory alloy hook members <NUM> into the fishhook configuration beneficially compresses the heart wall tissue surrounding the central receiver portion <NUM>, thereby improving the performance of the tissue anchor <NUM>. In addition, the shape memory alloy hook members <NUM> also spread the tensile forces placed on the second implant member by the elongated filament <NUM> across a larger heart wall area reducing the point tensile forces exerted on the heart wall.

In embodiments, the shape metal alloy anchor <NUM> may include one or more biologically compatible shape metal alloys, such as a Nickel-Titanium (NiTi) alloy. One of skill in the relevant arts will readily appreciate that a large number of biologically compatible shape metal alloys exist and other such alloys may be substituted with equal performance and efficiency.

From the foregoing disclosure, it should be understood that the present disclosure provides systems, apparatus and methods to repair operation of a heart valve, particularly by chordae tendineae repair and replacement, with the filament <NUM> of the tether <NUM> acting as a replacement (artificial) chordae tendineae. Further, after a period of implantation, the filament <NUM> may be coated with endothelial cells, which may result in a native replacement chordae tendineae, with the filament <NUM> providing a scaffold for the endothelial cells to proliferate.

Thus, the present disclosure discloses multiple, initially separate, implant members <NUM> and <NUM>, with one implant member <NUM> having at least one fastener <NUM>, <NUM> fastenable (anchorable) to a leaflet <NUM>/<NUM> of a valve <NUM>/<NUM>, and another implant member <NUM> having at least one anchor <NUM> anchorable to the heart wall, such as the papillary stalk <NUM>, and/or other wall of the heart tissue. Each implant member <NUM>, <NUM> includes a connector <NUM>, <NUM> which are configured to couple with each other via magnetic force. One of the implant members <NUM> further comprises a tether <NUM> which provides a replacement (artificial) chordae tendineae having a length with his adjustable after the connectors <NUM>, <NUM> of the implant members <NUM>, <NUM> are magnetically coupled.

It should be understood that, while a single continuous tether <NUM> is shown as extending from first fastener body <NUM> to second fastener body <NUM>, particularly through through-hole <NUM> in the first implant member connector body <NUM>, a plurality of continuous tethers <NUM> may extend continuously from the first fastener body <NUM> to the second fastener body <NUM> through through-hole <NUM>. In such manner, if one of the tethers <NUM> should break, the first fastener <NUM> to second fastener <NUM> will still remain fastened together by another tether <NUM>. Only one tether <NUM> is shown for the sake of clarity, and additional tethers <NUM> (e.g. <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) are not shown as merely being duplicative <NUM>.

In another embodiment of first implant member <NUM>, through hole <NUM> of the first implant member connector body <NUM> may be eliminated, and a first tether 130a may connect between the first fastener body <NUM> and the first implant member connector body <NUM>, and a second tether 130b may connect between the second fastener body <NUM> and the first implant member connector body <NUM>. Additionally, first fastener body <NUM> may include a centrally located through hole (bore) <NUM> which extends from the tissue retention (anchoring) end <NUM> to the tissue penetrating (pointed piercing) end <NUM>, similar to that of second fastener body <NUM>, as well as locking elements <NUM>.

In the foregoing manner, each of the tethers 130a, 130b may have locking elements <NUM> to independently adjustably fix the distance of the first tether 130a between the first fastener body <NUM> and the first implant member connector body <NUM>, and the second tether 130b between the second fastener body <NUM> and the first implant member connector body <NUM>. It should be again understood that, while only one of each of tethers 130a, 130b is shown, additional tethers 130a, 130b (e.g. <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) are contemplated, but are not shown for the sake of clarity, as merely being duplicative.

Claim 1:
An implant configured to control travel of a leaflet of a heart valve, the implant comprising:
a first implant member (<NUM>) that includes:
at least one mechanical tissue fastener (<NUM>, <NUM>);
a first implant member connector (<NUM>); and
an adjustable length tether (<NUM>) connecting the at least one mechanical tissue fastener (<NUM>, <NUM>) and the first implant member connector (<NUM>); and
a second implant member (<NUM>) that includes:
a magnetic second implant member connector (<NUM>); and
a tissue anchor (<NUM>);
wherein the first implant member connector (<NUM>) and the second implant member connector (<NUM>) are magnetically couplable.