Patent Description:
Mitral insufficiency (MI) is a form of heart disease where the mitral annulus excessively dilates and the valve leaflets no longer effectively coapt during systolic contraction. Regurgitation occurs during ventricular contraction and cardiac output decreases.

An annuloplasty procedure may be performed to restore the physiological form and function of the mitral annulus. Annuloplasty procedures may involve surgically implanting a ring around the mitral annulus to restore a diameter of the patient's mitral annulus to that of a healthy state where the valve leaflets properly coapt and mitral regurgitate flow is minimized. Additionally, sub-valvular repair procedures such as repositioning of papillary muscles or repairing chordae within the left ventricle may be performed.

Due to the invasive nature of the surgical approaches to mitral valve repair, several transcatheter techniques have been developed to emulate surgical approaches. Delivery catheters may extend up to <NUM>" in length and may carry mitral valve or sub-valvular repair components for distal delivery to a treatment site. The challenges of advancing components through a catheter include difficulties maintaining an orientation, spacing and/or integrity of the components, as well as component entanglement.

<CIT> discloses an implantable device for controlling the shape and/or size of an anatomical structure or lumen. <CIT> discloses a device for the endovascular repair of cardiac valves. <CIT> discloses devices for transvascular prosthetic chordae tendinea implantation.

The present invention is directed to a delivery catheter for cardiac repair components as set forth in the appended claims. According to the invention, the delivery catheter includes a first channel extending from a proximal end to a distal end of the delivery catheter, the first channel configured for axial translation of a first component to a treatment site. The delivery catheter further includes a second channel, extending from the proximal end of the delivery catheter to the distal end of the delivery catheter, the second channel configured for axial translation of a second component to the treatment site, where the first component is coupled to the second component, and the first component is configured for axial translation through the first channel in coordination with axial translation of the second component through the second channel for concurrent deployment of the first component and second component from the delivery catheter. An axially translatable opening is provided between the first channel and the second channel. The delivery catheter further includes a guide catheter disposed within the delivery catheter, where the first channel is disposed between the guide catheter and the delivery catheter. The delivery catheter includes an anchor catheter disposed within the guide catheter, the anchor catheter including a slit extending through the anchor catheter from a distal end of the anchor catheter to a proximal end of the anchor catheter, the anchor catheter providing the second channel. The guide catheter includes a window extending therethrough, the window slidably disposed over the slit of the anchor catheter, where the window of the guide catheter and slit of the anchor catheter cooperate to provide the axially translatable opening between the first channel and the second channel.

According to various embodiments, the first channel and second channel may be configured to couple the first component to the second component while limiting interaction between the first component and the second component. The second channel may be configured to limit rotational movement of the second component during translation of the second component through the second channel, where the first channel is disposed within a portion of the second channel defined by the second component.

In one embodiment, the second channel may include a bore sized to limit rotation of the second component, and the first channel may be disposed between features of the second component. In one embodiment, the bore may correspond in size and shape to the second component. The first component may include a suture and the second component may include an anchor having a suture coupling, and the suture may extend through the suture coupling of the anchor. In one embodiment, the suture coupling may be disposed within the second channel. In other embodiments, the suture coupling may be disposed within the first channel.

In one embodiment, the delivery catheter may include a plurality of anchors, and the suture may extend from a proximal handle of the delivery catheter through the plurality of anchors and back to the proximal handle. In other embodiments, the delivery catheter may include a plurality of anchors, and the suture may be fixedly attached to a first anchor of the plurality of anchors and extend through each of the plurality of anchors to the proximal end of the delivery catheter.

In one embodiment, the second component may include a body and a coupler for engaging the first component, the first channel may be configured to carry the coupler and the second channel may be configured to carry the body.

According to another aspect, a cardiac repair system includes a suture, a plurality of anchors, and a delivery catheter. The delivery catheter includes a first channel extending from a proximal end to a distal end of the delivery catheter, the first channel configured for axial translation of the suture to a treatment site, a second channel, extending from the proximal end of the delivery catheter to the distal end of the delivery catheter, the second channel configured for axial translation of the plurality of anchors to the treatment site. A portion of the suture may be coupled to an anchor and the delivery catheter may be configured for axial translation of the portion of the suture through the first channel in coordination with axial translation of the anchor through the second channel for concurrent deployment of the portion of the suture and the anchor without interference.

In some embodiments, the second channel may include a bore sized to limit rotation of at least one anchor of the plurality of anchors, and the first channel may be defined by features of the at least one anchor. The bore may correspond in size and shape to the at least one anchor. The cardiac repair system may further include an axially translatable opening disposed between the first channel and the second channel.

In some embodiments, the cardiac repair system may include a guide catheter disposed within the delivery catheter, the first channel disposed between the guide catheter and the delivery catheter. An anchor catheter may be disposed within the guide catheter, the anchor catheter including a slit extending through the anchor catheter from a distal end of the anchor catheter to a proximal end of the anchor catheter, the anchor catheter providing the second channel. The guide catheter may include a window extending therethrough, the window slidably disposed over the slit of the anchor catheter, where the window of the guide catheter and slit of the anchor catheter cooperate to provide the axially translatable opening between the first channel and the second channel.

The present disclosure also provides a method for cardiac repair includes the steps of: coupling a first anchor to a suture, axially translating the suture through a first channel of a delivery catheter, axially translating the first anchor through a second channel of the delivery catheter in coordination with axial translation of the suture, concurrently deploying a first portion of the suture and the first anchor to a treatment site, axially translating a second anchor through a second channel of the delivery catheter in coordination with axial translation of the suture, and concurrently deploying a second portion of the suture and the second anchor to a treatment site.

In some embodiments, the delivery catheter includes an axially translatable opening disposed between the first channel and the second channel, and the step of axially translating the first anchor through a second channel of the delivery catheter in coordination with axial translation of the suture may include the steps of: introducing either a coupling portion of the first anchor into the first channel or introducing the first portion of the suture into the second channel to form a join between the first anchor and the first portion of the suture, aligning the axially translatable opening between the first channel and the second channel with the join between the first anchor and the first portion of the suture and advancing the axially translatable opening of the delivery catheter in coordination with the join to minimize an exposure between the first channel and the second channel.

In the figures, each identical or nearly identical illustrated component is typically represented by a single numeral. In the figures:.

The present invention is directed to a delivery catheter for cardiac repair components as set forth in the appended claims. Where in the following the unit "inch" is employed, this conversion applies: <NUM> inch = <NUM>.

A delivery catheter as disclosed herein may be configured in various embodiments to maintain an orientation, a spacing and/or separation of annuloplasty or other cardiac repair components as they are translated through the delivery catheter to a treatment site. For example, cardiac repair components may include one or more anchors coupled by sutures. The anchors may be deployed to a heart wall, annulus or other heart feature and the suture cinched or otherwise tightened to adjust the spacing between the deployed anchors. Such a system may be used to bring tissue features of the heart closer together, for example, for valvular and/or sub-valvular repair procedures such as annuloplasty and repair, replacement and/or repositioning of a valve leaflet, a papillary muscle or chordae to improve valve function.

According to one aspect, the delivery catheter may be configured in various embodiments to minimize the potential for entanglement between repair components such as between sutures and coupled anchors. The embodiments include embodiments that separate an anchor translation channel from a suture translation channel while maintaining the coupling between the anchor and the suture. In some embodiments, the coupling may include a suture coupling of an anchor, the suture coupling comprising a suture lumen extending through a portion of the anchor and configured to attach to or to slideably carry the suture. In various embodiments, the suture coupling is isolated from other repair components. In some embodiments wherein the anchor comprises talons, barbs or the like on a distal end, the delivery catheter is configured such that the suture coupling is spaced apart from the talons to minimize the potential for entanglement. In some embodiments, the suture coupling may be disposed in a channel that is the same as or separate from the anchor talons. In some embodiments, the delivery catheter may be configured to maintain an anchor orientation during translation, which may further reduce the potential of entanglement of components during delivery.

These and other beneficial aspects of a delivery catheter configured to maintain one of separation, spacing and/or orientation of anchors during annuloplasty or are described in more detail below. It should be noted that, although embodiments of the present disclosure may be described with specific reference to papillary muscles, the principles disclosed herein may be readily adapted to facilitate reconstruction of various heart features, including but not limited to a mitral or tricuspid valve annulus and/or may similarly benefit any other dilatation, valve incompetency, valve leakage and other similar heart failure conditions.

As used herein, the term "distal" refers to the end farthest away from the medical professional when introducing a medical device into a patient, while the term "proximal" refers to the end closest to the medical professional when introducing a medical device into a patient.

<FIG> is a diagram of a left chamber of a heart <NUM>, including a left atrium <NUM> separated from a left ventricle <NUM> by mitral valve <NUM>. The mitral valve <NUM> includes an anterior leaflet 122a and a posterior leaflet 122b which are attached in a healthy heart to respective papillary muscles 134a, 134b via chordae tendineae 132a, 132b. The papillary muscles 134a, 134b contract to prevent inversion or prolapse of the valves 122a, 122b on contraction of the left ventricle <NUM>. A mitral annulus <NUM> comprises a fibrous ring that, in a healthy heart is saddle shaped and of a diameter to enable the valves to close, or coapt, during systolic contraction.

In a diseased heart, one or more of the chordae tendineae 132a, 132b may be stretched or ruptured, resulting in a flailing leaflet 122a, 122b that no longer effectively closes, resulting in regurgitation. Alternatively, or in conjunction, the mitral annulus <NUM> may become stretched or deformed, and the valves may also fail to close as a result.

To repair the heart failure condition, repair components may be transluminally deployed to the heart <NUM>. In <FIG>, a delivery catheter <NUM> is shown advanced through a femoral artery to the aorta <NUM> and into the left ventricle <NUM> for transfemoral retrograde delivery of repair components. Depending upon the heart feature that is to be repaired it is appreciated that the delivery catheter is not limited by the manner in which it is introduced to the heart <NUM>. For example, to deliver repair components to a left atrium, a transapical or transseptal delivery pathway may be used with embodiments of the delivery catheter and system disclosed herein.

In one embodiment, the delivery catheter <NUM> may have a steerable distal end <NUM> to facilitate navigation of repair components <NUM> that are disposed within the distal end of the delivery catheter <NUM> into a heart chamber. During delivery, a distal guidewire (not shown) may assist with transluminal navigation. Upon arrival at the treatment site, repair components <NUM> may be advanced through the distal end <NUM> of the delivery catheter <NUM> as part of the cardiac procedure.

One embodiment of a delivery catheter <NUM> in accordance with the invention is shown from a side perspective in <FIG> and a top-down perspective in <FIG>. The delivery catheter <NUM> is shown to include a shaft <NUM> having a steerable distal end <NUM> aligned along an axis A to a handle <NUM> of a proximal end <NUM>. The steerable shaft <NUM> may include embedded pull cables coupled to mechanisms in the handle <NUM> and configured to deflect the distal end <NUM> of the shaft <NUM> as it travels through the lumens of arteries or veins to a treatment site such as a cardiac cavity. In one embodiment, the delivery catheter <NUM> may comprise one or more sheaths, each sheath comprising a composite of layers of thermoplastic elastomer (TPE), for example PEBAX provided by ARKEMA corporation of Colombes France. Alternatively, nylon, polyurethanes, polyester, silicone or other similar materials may be used to provide thin walls that may be extruded and layered over braided wires or coils for tensile and hoop strength, although the disclosed system is not limited to any particular material composition for the delivery catheter. In some embodiments, the length of the shaft <NUM> may range from between <NUM>"-<NUM>", and more particularly between <NUM>"-<NUM>". In one embodiment, the inner diameter may range between <NUM>-<NUM> Fr, and the outer diameter may range between <NUM> Fr and <NUM> Fr or more. In an exemplary embodiment, an inner diameter may be, for example <NUM> Fr and the outer diameter may be <NUM> Fr.

According to one aspect, the delivery catheter <NUM> includes a delivery catheter lumen extending axially through catheter <NUM> from the proximal end <NUM> to the distal end <NUM> as shown by line 'A' of <FIG>. As described in more detail below, in various embodiments the anchor lumen may be apportioned into one or more channels separating translation of the anchors, sutures and/or anchor/suture coupling from other repair components during deployment.

The handle <NUM> may include a steering control mechanism such as dial <NUM> which may control the deflection of the distal end <NUM> of the delivery catheter <NUM> during transluminal navigation. Alternative steering control mechanisms may include, for example, thumbwheels, dials, knobs, switches and the like.

In some embodiments, the handle <NUM> may further include an anti-tangle device configured to align sutures to reduce tangling that would frustrate an anchoring procedure, for example an anchor feed cylinder <NUM>.

<FIG> is a top down perspective view of the delivery catheter <NUM>, illustrating the shaft <NUM>, coupled to its proximal end to the handle <NUM> which in turn is coupled to the anchor feed cylinder <NUM>. In <FIG>, anchor feed cylinder <NUM> is shown to include a slot <NUM> that extends through its proximal end and may be configured to separate translation of sutures and anchors through the delivery catheter <NUM>. For example, the anchor feed cylinder <NUM> may be configured to align an anchor with a first channel extending from the proximal end <NUM> to /through the distal end <NUM>, and to align the suture with a second channel that extends from the proximal end <NUM> to/through the distal end <NUM> to enable translation of a coupled suture/anchor pair through the shaft without entanglement.

<FIG> illustrate one embodiment of an anti-tangle device <NUM> that may be used to reduce suture interference during a suturing procedure. <FIG> illustrates a handle <NUM> configured to control a delivery sheath <NUM> as described above. The anti-tangle device <NUM> may be disposed at the proximal end of the handle <NUM>. In various embodiments, the anti-tangle device <NUM> may be integral with or detachable from the proximal end of the handle <NUM>. The anti-tangle device <NUM> is shown to include a body <NUM> coupled to or integral with the proximal end of the handle. In one embodiment, the body <NUM> may comprise a ring or similar structure having one or more openings extending therethrough to enable sutures and anchors to be fed through the handle <NUM> for deployment to a treatment site. A pair of arms 376a, 376b include respective distal ends 373a, 373b fixedly or releasably attached to spaced apart locations upon or within the body <NUM> of the anti-tangle device <NUM>. In the illustrated embodiment, arm 376a is shown disposed on an opposing side of body <NUM> from arm 376b, although the present disclosure is not so limited.

The arms 376a, 376b further include proximal ends supporting alignment heads 372a, 372b. The arms 376a, 376b are advantageously configured to displace the alignment heads 372a, 372b from each other. Displacing the alignment heads 372a, 372b allows sutures 374a, 374b to be fed through the alignment heads and into the handle <NUM> without interference and associated entanglement issues. It should be noted that although two arms are shown, similar solutions which have a single arm comprising spaced apart branches, each branch supporting one or more of the alignment heads are within the scope of this disclosure.

<FIG> is a close up perspective view of one embodiment of alignment head 372a. The alignment head 372a is shown to include an eyelet <NUM> disposed on the proximal end of arm 376a, the eyelet <NUM> having a bore <NUM> extending therethrough and sized in diameter to slideably support a suture line. A slot <NUM>, extending through the eyelet <NUM> into the bore <NUM>, enables the suture to be introduced into the bore <NUM>, to allow the bore <NUM> to guide translation of the suture into the handle <NUM> (<FIG>) to reduce opportunity for entanglement that may frustrate a cardiac procedure.

<FIG> illustrates a distal end <NUM> of a delivery catheter <NUM> having an anchor lumen <NUM> extending therethrough. The delivery catheter <NUM> is shown deploying repair components including anchors <NUM> and <NUM> and a suture <NUM>. The anchors <NUM> and <NUM> may be deployed for anchoring in a heart feature <NUM> to repair heart function. Anchor <NUM> is shown to include a talon 423a disposed at a distal end, and a suture coupler including an eyelet 423b disposed at the proximal end. Anchor <NUM> similarly comprises a talon 433a disposed at a distal end and an eyelet 433b disposed at a proximal end. Although the talon 423a and eyelet 423b combination are shown, the present disclosure is not limited to any particular anchor or suture coupling mechanism. Rather, anchors comprising barbs, hooks, screws, helical anchors and the like may be readily substituted herein depending upon the form of repair. In addition, other suture coupling mechanisms enabling fixed or slidable translation of the suture relative to a proximate anchor, including clips or lumens extending through or partially through an anchor body may alternatively be used.

According to one aspect, the anchors <NUM>, <NUM> may be comprised of a shape memory material, for example a copper-aluminum-nickel, a nickel-titanium (NiTi) alloy or other alloy of zinc, copper, gold and/or iron. In one embodiment, the anchors <NUM>, <NUM> may include a first configuration, such as the configuration of anchor <NUM>, that facilitates translation of the anchor <NUM> through the anchor lumen <NUM>, and may revert to a second configuration, such as the configuration of anchor <NUM>, when released from the distal end <NUM> of the delivery catheter <NUM> to a treatment site, the second configuration exposing the talons 423a to tissue.

In one embodiment, the suture <NUM> may be a continuous line having a first end 426a that loops around an initially deployed anchor, such as anchor <NUM>, and returns back through the anchor lumen <NUM> to the proximal end the delivery catheter <NUM> at a second end 426b. Subsequent anchors, such as anchor <NUM>, may then be translated over either the first end 426a or the second end 426b of the suture line <NUM> to a desired treatment location.

In other embodiments, the suture may be terminated at, or otherwise affixed to, the first, distal most anchor and fed through subsequently translated anchors, for example as shown in <FIG> illustrates a delivery catheter <NUM> having an anchor <NUM> deployed through a distal end <NUM> of the delivery catheter using a push rod <NUM>. Delivery catheter <NUM> may include a handle (not shown) coupled to its proximal end <NUM>. In the embodiment of <FIG>, the suture <NUM> is shown affixed to the initial anchor <NUM>, and the push rod <NUM> is shown advancing the anchor <NUM> towards a heart feature <NUM>.

In <FIG>, the anchor <NUM> has been affixed to the heart feature <NUM>, and the push rod withdrawn from the delivery catheter <NUM>. The suture <NUM> extends from the affixed anchor <NUM> through the proximal end <NUM> of the delivery catheter <NUM>.

In <FIG>, a second anchor <NUM> is advanced through the delivery catheter <NUM>. In one embodiment, the anchor <NUM> may be threaded over the suture <NUM>, for example through eyelet <NUM> of anchor <NUM>. The anchor <NUM> may be advanced from the proximal end <NUM> of the delivery catheter <NUM> over suture <NUM> using push rod <NUM> and directed towards the heart feature <NUM>, for placement with anchor <NUM>, or may be directed towards another heart feature.

In accordance with the invention, <FIG> illustrate perspective and cross-sectional views of a distal end of one embodiment of a delivery catheter <NUM> configured to maintain one or more of a separation, orientation and/or spacing between repair components. The delivery catheter <NUM> is shown in <FIG> to be comprised of a plurality of sheaths, including a delivery catheter sheath <NUM>, a guide sheath <NUM> and an anchor sheath <NUM>, wherein the anchor sheath <NUM> is translatably disposed within the guide sheath <NUM>, and the guide sheath is translatably disposed within the delivery catheter sheath <NUM>. According to one aspect, replacement components such as anchors may be translated through the anchor sheath <NUM>, using a push rod (not shown) or other translation mechanism. Thus, the anchor sheath <NUM> provides an anchor translation channel for deploying anchors to the treatment site.

In <FIG>, the delivery sheath <NUM> and guide sheath <NUM> are shown in cross section, exposing the anchor sheath <NUM> for view. In one embodiment, the anchor sheath may comprise a slit <NUM> extending from a proximal end <NUM> to a distal end <NUM> of the anchor sheath <NUM>. In some embodiments, the slit <NUM> may extend to a proximal handle of the delivery catheter, for example to align with the slot <NUM> of the anchor feed cylinder <NUM> (<FIG>) of a delivery catheter handle. According to one aspect, the slit <NUM> exposes the anchor translation channel provided by the anchor sheath <NUM> to a suture translation channel that is maintained separately from the anchor translation channel (for example, between the delivery sheath <NUM> and the guide sheath <NUM>) to minimize interaction between suture and anchor repair components.

For example, <FIG> is a second view of the catheter <NUM>, where the delivery sheath <NUM> is shown in cross section to expose the guide sheath <NUM>. The anchor sheath <NUM> is shown extending from the distal end of the guide sheath <NUM>.

According to one aspect, the guide sheath <NUM> may have one or more openings extending therethrough, such as window <NUM>. The window may expose a portion of the anchor sheath comprising the slit <NUM>, providing a passageway for the suture to couple with a coupler <NUM> of an anchor <NUM>, while allowing the guide sheath <NUM> to keep the suture <NUM> from tangling with anchors <NUM>.

For example, in one embodiment the slit <NUM> in the access sheath extends longitudinally through the proximal end of the handle <NUM> (<FIG>) of a delivery catheter. An anchor may be threaded over or tied to suture <NUM> and pushed through the anchor sheath <NUM> by advancement of the guide sheath <NUM> over the anchor sheath. In <FIG>, anchor <NUM> is shown positioned within the anchor sheath <NUM> such that a coupler <NUM> of the anchor <NUM> is oriented towards the slit <NUM>, which in turn is oriented towards the window <NUM>. Translation of the guide sheath <NUM> over the anchor sheath <NUM> essentially pulls the anchor <NUM> longitudinally through the anchor sheath <NUM> to the treatment site. At the distal end <NUM> of the catheter <NUM>, the anchor may be released by rotating the guide sheath to release the joined suture <NUM>/ coupler <NUM> pair. The anchor may then be deployed to target tissue using a push rod (not shown) to push the anchor out of the anchor sheath.

<FIG> illustrates a longitudinal cross section of catheter <NUM>, illustrating the anchor sheath <NUM> disposed within the guide sheath <NUM> which in turn is disposed within the delivery catheter <NUM>. In <FIG>, a sidewall <NUM> of slit <NUM> (<FIG>) is shown. Anchor <NUM> is disposed within the anchor sheath <NUM>, and the suture <NUM> is shown to extend through the window <NUM> within guide sheath <NUM>, past the sidewall <NUM> of the slit <NUM>, through anchor coupler <NUM> of anchor <NUM>, past sidewall <NUM> and out window <NUM> to the channel <NUM> between delivery sheath <NUM> and guide sheath <NUM>. By providing a system with separate translation channels for the suture <NUM> and the anchor <NUM>, the potential for entanglement is reduced. The slit <NUM>/window <NUM> arrangement of the anchor catheter <NUM>/ guide catheter <NUM> pair further assists with maintaining the orientation of the anchor <NUM> within the anchor catheter <NUM>.

Although an embodiment having one window <NUM> configured to deploy one anchor is shown, it is appreciated that other arrangements, for example having guide catheters with two or more windows spaced apart along the longitudinal extend of the guide catheter are within the scope of this disclosure. In such embodiments, the guide catheter/anchor pair arrangement may further assist with controlling a relative spacing of the anchors during deployment.

<FIG> illustrates a view of the distal end <NUM> of the catheter <NUM> wherein an anchor <NUM> has been advanced to the distal end of the anchor catheter <NUM> and is ready for release to a treatment site within a heart cavity. In one embodiment, distal advancement of the anchor <NUM> to the treatment site is enabled by translating the guide catheter <NUM> within the delivery catheter <NUM>. As the window <NUM> advances along the anchor sheath <NUM> due to advancement of the guide catheter <NUM> within the delivery catheter <NUM>, the window <NUM> distally translates the suture <NUM> within the slit <NUM>, maintaining the position of the anchor coupler <NUM> relative to window <NUM>.

When the anchor <NUM> reaches the distal end <NUM> of the delivery catheter <NUM>, the guide sheath <NUM> may be advanced past the distal end of the anchor catheter and rotate to release the anchor to the treatment site. In some embodiments, the window <NUM> may be part of a notched opening at the distal end of the guide catheter as shown in <FIG>. With such an arrangement, rotation of the guide catheter may facilitate the release of the suture from the distal end of the anchor catheter.

Accordingly, a delivery catheter and system has been shown and described that uses cooperating sheaths to provide separate translation channels for repair components such as sutures and anchors.

In some embodiments, a delivery catheter may be formed with internal features configured to maintain the orientation of the anchor within the catheter. The internal features may include channels that may be cooperate with features of the anchors or other components to streamline component delivery.

For example, <FIG> illustrates one embodiment of a distal end <NUM> of an anchor catheter <NUM> including a bore <NUM> extending therethrough. The bore <NUM> includes internal features configured to maintain orientation of an anchor <NUM>. For example, the bore <NUM> may be configured to accept the anchor in a single, predetermined orientation and/or position, and to maintain the predetermined orientation and/or position along the extent of the delivery catheter. Designing the bore of the delivery catheter in such a manner as to preclude rotation of the anchor within the bore reduces the potential for repair component entanglement.

In addition, configuring the bore <NUM> to limit the movement of the anchor within the anchor catheter in this manner, features of the anchor may be used to provide a suture translation channel that is separated from talons <NUM> of the anchor <NUM>.

For example, in <FIG>, the bore <NUM> is generally rectangular in shape, with diagonal extend DE matched to a maximum distance between anchor talon endpoints 753a, 753b of the anchor <NUM> when the anchor <NUM> is in a compressed state within the anchor catheter <NUM>. As such, the anchor <NUM> is precluded from rotating within the bore <NUM>.

Because the anchor <NUM> is precluded from rotating within the bore <NUM>, spaces between anchor features may be used as channels to support repair elements without risk of entanglement. For example, a channel <NUM>, defined between anchor talon <NUM> and <NUM> may be used to carry the suture <NUM>, for example as the anchor <NUM> is translated to the treatment site. In embodiments such as that shown in <FIG>, the anchor may be distally translated using a push rod or other device that is slidably translatable within the bore <NUM> of the anchor sheath <NUM>.

The anchor sheath <NUM> may comprise a delivery catheter, or may comprise a separate working catheter, translatable within a delivery catheter for delivering components to the treatment site.

<FIG> illustrates an embodiment of a distal end <NUM> of an anchor catheter <NUM> having a shaped bore <NUM>, wherein the shape of the bore <NUM> is generally matched to the size and shape of an anchor <NUM>, to preclude rotation or disorientation of the anchor <NUM> as it is translated through the anchor sheath <NUM>. In <FIG>, a channel <NUM> may be reserved within the bore <NUM> to support sutures <NUM>. Because the bore <NUM> is matched in general size and shape to the anchor <NUM>, the likelihood of interference between sutures <NUM> and the anchor is minimized.

<FIG> illustrate perspective views of another embodiment of a delivery catheter system for use in deploying repair mechanisms to a treatment site within a heart. It is appreciated that modifications to the anchors as well as the delivery catheter may further assist in maintaining the orientation, spacing and/or separation between repair components such as anchors and sutures.

<FIG> illustrates a distal end <NUM> of a delivery catheter <NUM> configured to support an anchor, such as anchor <NUM>. Anchor <NUM> is shown in a pre-deployed state within the delivery catheter <NUM> in <FIG>, and in a post-deployed state in <FIG>. In <FIG>, delivery catheter <NUM> is shown to include two channels, a suture translation channel <NUM> and an anchor translation channel <NUM>. A slit <NUM> couples the suture translation channel <NUM> to the anchor translation channel <NUM>. During use, in the embodiment of <FIG>, the suture <NUM> may be advanced through the suture translation channel <NUM>. An anchor coupler <NUM> extends from an anchor <NUM> that is translatably disposed within the anchor translation channel <NUM> into the suture translation channel <NUM> through a slit <NUM> that joins the two channels. In one embodiment, the anchor coupler <NUM> includes an eyelet <NUM> or other opening that provides a suture lumen <NUM> configured to support a suture <NUM> along which the anchor <NUM> may be advanced towards the treatment site.

<FIG> is a longitudinal cross section view of the delivery catheter <NUM>. In <FIG>, the anchor <NUM> is disposed such that the talons <NUM> are in a compressed state to facilitate translation of the anchor <NUM> through the anchor translation channel <NUM>. Sidewall <NUM> comprises a sidewall of the slit <NUM> of <FIG>. As shown in <FIG>, the eyelet <NUM> extends up past the sidewall <NUM> of the slit into the suture translation channel <NUM>. Suture <NUM> may be attached or threaded through the eyelet <NUM> as the anchor <NUM> is introduced into anchor translation channel <NUM>. With such an arrangement, the likelihood of interference between the talons <NUM> of the anchor <NUM> and the suture <NUM> is greatly reduced.

<FIG> illustrates an embodiment of the anchor <NUM>, following release from the distal end <NUM> of the delivery catheter <NUM> (<FIG>). In one embodiment, as the anchor <NUM> is pushed out of the anchor translation channel <NUM>, the talons <NUM> of the anchor <NUM> may return to their native configuration, enabling the talons <NUM> to expand to engage tissue. As anchors are deployed from the delivery catheter, the talons <NUM>, burrs, barbs or other anchor features may be pushed into tissue, for example by pressure exerted upon the anchor <NUM> by the distal end of the delivery catheter or other tool, such as a push rod, that may be extended through the anchor translation channel. The suture <NUM> extends through (or alternatively may be attached to) the eyelet <NUM> and may be used to bind anchor <NUM> to previously or subsequently deployed anchors. Such an arrangement facilitates heart repair techniques that deploy and cinch multiple anchors by reducing the opportunity for entanglement and thereby improving technique outcomes.

<FIG> is a diagram of a heart <NUM> that is used herein to describe an exemplary repair technique that may be used to restore mitral valve function when mitral valve function is impaired by degraded function of the chordae tendineae <NUM>. For example, stretching or rupture of the chordae tendineae <NUM> may result in leaflet flailing, wherein the leaflets of the mitral valve <NUM> fail to coapt during systole, causing mitral regurgitation.

According to one aspect it is realized that drawing together the anterior papillary muscle <NUM> and the posterior papillary muscle <NUM> may draw together the valves <NUM> and/or reduce the volume of the left ventricle to improve cardiac function.

A delivery catheter such as that described herein may advantageously be used to deploy multiple anchors, such as anchors <NUM>, <NUM>, <NUM> and <NUM> to the papillary treatment site over a single suture <NUM>. The ends of the suture <NUM> may then be cinched to draw together the anchors <NUM>-<NUM> and the associated papillary muscles <NUM>, <NUM>. A resistive weld, band, or other cinch device <NUM> may then be used to join the ends of the suture <NUM>, and the delivery catheter <NUM> may be withdrawn back through the aorta <NUM> and removed from the patient. Other methods of deployment, including transapical, transseptal or other approaches may alternatively be used.

While it is appreciated that it may be beneficial in such systems to include a suture <NUM> that loops proximally back to the handle to assist with cinching, the present disclosure is not limited to a looped suture. Rather, repair techniques that use a single, non-looped suture, such as that described with regard to <FIG> may benefit from the delivery catheter design principles disclosed herein, that maintain orientation, spacing and/or separation between anchors.

Various modifications to the implementations described in this disclosure will be readily apparent to those skilled in the art, and the generic principles defined herein can be applied to other implementations without departing from the scope of this disclosure. Thus, the disclosure is not intended to be limited to the implementations shown herein but is to be accorded the widest scope consistent with the claims, the principles and the novel features disclosed herein. The word "example" is used exclusively herein to mean "serving as an example, instance, or illustration. " Any implementation described herein as an "example" is not necessarily to be construed as preferred or advantageous over other implementations, unless otherwise stated.

Certain features that are described in this specification in the context of separate implementations also can be implemented in combination in a single implementation. Conversely, various features that are described in the context of a single implementation also can be implemented in multiple implementations separately or in any suitable sub-combination. Moreover, although features can be described above as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination can be directed to a sub-combination or variation of a sub-combination. Additionally, other implementations are within the scope of the following claims.

It will be understood by those within the art that, in general, terms used herein are generally intended as "open" terms (e.g., the term "including" should be interpreted as "including but not limited to," the term "having" should be interpreted as "having at least," the term "includes" should be interpreted as "includes but is not limited to," etc.). It will be further understood by those within the art that if a specific number of an introduced claim recitation is intended, such an intent will be explicitly recited in the claim, and in the absence of such recitation no such intent is present. However, the use of such phrases should not be construed to imply that the introduction of a claim recitation by the indefinite articles "a" or "an" limits any particular claim containing such introduced claim recitation to embodiments containing only one such recitation, even when the same claim includes the introductory phrases "one or more" or "at least one" and indefinite articles such as "a" or "an" (e.g., "a" and/or "an" should typically be interpreted to mean "at least one" or "one or more"); the same holds true for the use of definite articles used to introduce claim recitations. In addition, even if a specific number of an introduced claim recitation is explicitly recited, those skilled in the art will recognize that such recitation should typically be interpreted to mean at least the recited number (e.g., the bare recitation of "two recitations," without other modifiers, typically means at least two recitations, or two or more recitations). Furthermore, in those instances where a convention analogous to "at least one of A, B, and C, etc." is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (e.g., "a system having at least one of A, B, and C" would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and/or A, B, and C together, etc.). In those instances where a convention analogous to "at least one of A, B, or C, etc." is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (e.g., "a system having at least one of A, B, or C" would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and/or A, B, and C together, etc.). It will be further understood by those within the art that virtually any disjunctive word and/or phrase presenting two or more alternative terms, whether in the description, claims, or drawings, should be understood to contemplate the possibilities of including one of the terms, either of the terms, or both terms.

Claim 1:
A delivery catheter (<NUM>, <NUM>, <NUM>, <NUM>) for cardiac repair components (<NUM>) comprising:
a first channel extending from a proximal end to a distal end of the delivery catheter, the first channel configured for axial translation of a first component to a treatment site; and
a second channel, extending from the proximal end of the delivery catheter to the distal end of the delivery catheter, the second channel configured for axial translation of a second component to the treatment site;
wherein the first component is coupled to the second component, and the first component is configured for axial translation through the first channel in coordination with axial translation of the second component through the second channel for concurrent deployment of the first component and second component from the delivery catheter;
an axially translatable opening between the first channel and the second channel,
characterized by
a guide catheter (<NUM>) disposed within the delivery catheter (<NUM>);
the first channel disposed between the guide catheter (<NUM>) and the delivery catheter (<NUM>); and
an anchor catheter (<NUM>, <NUM>, <NUM>) disposed within the guide catheter (<NUM>), the anchor catheter (<NUM>, <NUM>, <NUM>) comprising a slit (<NUM>) extending through the anchor catheter (<NUM>, <NUM>, <NUM>) from a distal end (<NUM>, <NUM>, <NUM>) of the anchor catheter to a proximal end (<NUM>) of the anchor catheter, the anchor catheter providing the second channel;
wherein the guide catheter (<NUM>) comprises a window (<NUM>) extending therethrough, the window (<NUM>) slidably disposed over the slit (<NUM>) of the anchor catheter (<NUM>, <NUM>, <NUM>), wherein the window (<NUM>) of the guide catheter (<NUM>) and slit (<NUM>) of the anchor catheter (<NUM>, <NUM>, <NUM>) cooperate to provide the axially translatable opening between the first channel and the second channel.