Patent Description:
The mitral valve lies between the left atrium and the left ventricle of the heart. The mitral valve includes an anterior leaflet and a posterior leaflet that coapt during systolic contraction. The mitral annulus is a saddle shaped fibrous ring that surrounds the mitral valve and supports the valve's leaflets. 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.

Annuloplasty is performed to regain mitral valve competence by restoring the physiological form and function of the normal mitral valve. Annuloplasty procedures may involve implanting a structure, such as a ring, stent, frame, or the like within the heart. Cardiac implants are subject to the chronic stresses and strains associated with cardiac muscle palpitation and it would thus be desirable to reduce the impact of chronic forces on a cardiac implant.

<CIT> and <CIT> disclose implants including a resizable frame having angled struts.

The present invention is directed to an implant as defined in the claims. The present disclosure relates to a valve annulus implant comprising resilient components configured to reduce the effects of chronic forces upon the implant during use. An implant in accordance with the invention includes a frame having a proximal end, a distal end, and adjacent struts joined at an apex. The implant includes a sleeve disposed about the apex, the sleeve configured to apply a force to the frame at one or more contact points, the sleeve including a resiliency feature selected to reduce stress resulting from the force at the one or more contact points. The sleeve includes a plurality of sleeve slots. The sleeve slots extend proximally from a distal end of the sleeve for a slot extent. At least two of the plurality of sleeve slots may be disposed on opposing sides of the sleeve or the same side of the sleeve. At least two of the plurality of sleeve slots differ by at least one of a length, a width, extent, or pattern. The resiliency feature may include one of a sleeve material and/or a sleeve design. The sleeve material may include one or more of nitinol, stainless steel, a polymer and cobalt chrome or other similar material. In some embodiments, the sleeve material may vary in elasticity and/or resilience at different locations of the sleeve. In addition, the sleeve may comprise a sleeve body having a bore extending therethrough, and the sleeve material is a hybrid material including a first material disposed within the bore and a second material disposed at least partially around the bore. The second material may be less elastic than the first material. The first material may coat at least a portion of the bore proximate to at least one contact point. The first material may alternatively comprise a bumper that is fixedly attached to the bore proximate to at least one contact point. The sleeve slot may differ in width over the slot extent. The sleeve slot may be greater than half a width of the sleeve. In addition, or alternatively, the sleeve slot may extend longitudinally along the sleeve or helically around the sleeve for the slot extent. The sleeve slot may extend helically around the sleeve for one or more turns. The sleeve slot may vary in pitch over the one or more turns.

The present disclosure also provides an implant delivery system includes a delivery catheter and a frame having a compressed configuration for advancement through the delivery catheter to a valve annulus and an expanded configuration for placement of the frame proximate the valve annulus for repair. The frame may include a proximal end, a distal end, and adjacent struts joined at an apex, and an actuator comprising a sleeve disposed about the apex, the actuator configured to drive the sleeve over the apex by pushing or rotating the actuator to compress the frame to a cinched configuration in which a force is applied to the adjacent struts to adjust a space between the adjacent struts. The sleeve may include a resiliency feature including one or both of a sleeve composition or a sleeve design configured to reduce the force exerted by the sleeve on the frame.

With such an arrangement, the resilient features may reduce the fracture risks by diminishing the impact of chronic stress and strain on the frame.

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

Annuloplasty implants may include components that interact and may experience fatigue during chronic operation of the implant. According to one aspect, an improved annuloplasty implant includes one or more resilient components configured to reduce the deleterious effects of component interaction. In one embodiment, an actuator sleeve of a cinching implant may be configured with at least one resiliency feature to improve the ability of the actuator sleeve to absorb the stress and strains caused by actuator sleeve/frame interaction. In various embodiments, the resiliency feature may relate to one or more of a material, a manufacture, a dimension, and/or design attribute of the actuator sleeve. In some embodiments, the resiliency feature may increase the elasticity of the actuator sleeve at contact points to absorb stress. Alternatively, or in conjunction, the resiliency feature may increase a deformability of the actuator sleeve, thereby increasing a contact surface area to better distribute stress along the sleeve.

These and other beneficial aspects of a resilient sleeve and method of manufacture and/or use are described in more detail below. It should be noted that, although embodiments of the present disclosure may be described with specific reference to mitral valves, the principles disclosed herein may be readily adapted to facilitate reconstruction of any valve annulus, for example including a 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> illustrates an implant <NUM> comprising a frame <NUM> disposed about a valve <NUM>. The frame <NUM> of the implant <NUM> supports actuators <NUM> and anchors 110a, 110b, wherein for purposes of clarity not all of the components of the implant are numbered. In one embodiment, the frame <NUM> may extend circumferentially around and partially axially along a central frame axis extending proximally-distally through a center point of the frame such that anchors 110a, 110b disposed on a distal end of the frame <NUM> are positioned proximate to a valve annulus <NUM>. The frame <NUM> may be generally symmetric with respect to the central frame axis although it need not be symmetric. The frame <NUM> may form a generally tubular shape, where herein "tubular" includes circular as well as other rounded or otherwise closed shapes. The frame <NUM> may be configured to change shape, size, and/or configuration. For example, the frame <NUM> may assume various shapes, sizes, configurations etc. during different phases of deployment such as during pre-delivery, delivery, tissue engagement, and cinching.

According to one embodiment, the frame <NUM> may be formed from one or more struts 112a, 112b, and 112c that may form all or part of the frame <NUM>, where the struts 112a, 112b, and 112c may include elongated structural members formed of a metal alloy, a shape memory material, such as an alloy of nickel titanium or other metals, metal alloys, plastics, polymers, composites, other suitable materials, or combinations thereof. In <FIG>, fourteen struts are shown although it is appreciated that in some embodiments, there may be fewer or more than fourteen struts.

In one embodiment, the struts of the frame <NUM> may be formed from the same, monolithic piece of material (e.g. tube stock). Thus, reference to struts 112a, 112b, and 112c may refer to different portions of the same, extensive component. Alternatively, reference to struts 112a, 112b, and 112c may refer to components that are formed separately and attached permanently together, for example by welding or other methods. In some embodiments, the struts 112a, 112b, and 112c may be separate components that are detachably coupled together to form proximal and distal apices. For example, the struts 112a, 112b are shown joined at their proximal ends to form a proximal apex with an actuator <NUM> mounted thereto. Struts 112b and 112c are joined at their distal ends with an anchor 110b coupled thereto.

In some embodiments, the terms "apex," apices," and the like may be used interchangeably with terms "crown," "crowns," and the like, as used herein, unless otherwise stated. In one embodiment, an 'apex' may include a proximal or distal portion of the frame. For example, <FIG> illustrates a portion of the frame <NUM>, where actuators have been removed to expose the proximal apex <NUM> of the frame <NUM>. A proximal apex <NUM> may include the portion of the frame where struts 112a, 112b adjoin, and a distal apex <NUM> may include the portion of the frame where struts 112b and 112c adjoin. The apex may also include that portion of the frame that may be constrained by the structure that adjoins the struts to form the apex. For example, a distal apex <NUM> includes the portion of the struts 112b, 112c having openings supporting anchor 110b. Proximal apex <NUM> includes the portion of struts 112a, 112b configured to support an actuator (not shown), and including the portion of the struts 112a, 112b along which the actuator may travel. In the embodiment of <FIG>, each strut is shown to include a flange, such as flange <NUM> configured to limit the extent of distal travel of the actuator, and thus the proximal apex <NUM> includes the portion of the strut extending from the flange <NUM> to the proximal tips 172a, 172b of the struts 112a, 112b. In the embodiment of <FIG>, the proximal apex <NUM> of the frame <NUM> is arranged to form a window <NUM> which is configured to carry a head of an actuator shaft. Other embodiments, wherein the frame is oriented such that anchors are more proximally located than sleeves such that a distal apex carries the sleeves and a proximal apex carries the anchors are also within the teaching of this disclosure.

Referring back to <FIG>, in one embodiment, the actuator <NUM> includes an actuator shaft <NUM> that is rotatably carried by the proximal end of the frame <NUM>, for example, the head of the actuator shaft <NUM> may be carried by the window <NUM> (<FIG>) of the proximal apex <NUM> of the frame <NUM>. The sleeve <NUM> may include internal features configured to interact with the features of the actuator shaft <NUM>, such that rotation of the actuator shaft <NUM> by a drive shaft (not shown) coupled to drive coupler <NUM> axially translates the sleeve <NUM> over the actuator shaft <NUM> and over struts 112a, 112b. In some embodiments, "axial" as applied to axial movement or restraint of the sleeves includes directions that are at least partially in the proximal or distal direction and that are parallel or generally parallel to a central axis extending through (e.g. proximally - distally) the frame. As shown in <FIG>, struts 112a and 112b extend away from the proximal apex in opposing directions. Distal advancement of the sleeve <NUM> over struts 112a, 112b pulls the struts together within the sleeve, and as a result reduces the distance between anchors 110a, 110b to reshape an annulus <NUM> around the valve <NUM>. In one embodiment, each sleeve <NUM> may be independently actuated in accordance with the reshaping objective for the associated anchor pair. When each sleeve has been actuated to configure their associated anchor pair, the drive shafts (not shown), coupled to drive couplers <NUM> may be released from the implant.

According to one aspect, each sleeve <NUM> may include one or more resiliency features configured to reduce the impact of chronic contact between the sleeve <NUM> and struts 112a, 112b. Such resiliency features may reduce the pressure of sleeve <NUM> upon the strut at edge contact points, such as at pressure point P1 of strut 112a, when the sleeve <NUM> is distally translated over strut 112a. Absent such resiliency features, the pressure P1 results in stress at stress point S1 of strut 112a, potentially causing fatigue of frame <NUM> over time. Resiliency features may increase the elasticity and/or deformability of the sleeve <NUM>, to reduce the impact of pressure P1 and associated stress S1. For example, in <FIG>, sleeve <NUM> is shown to include a sleeve window <NUM>, that enables the sleeve <NUM> to deform at its distal end to relieve stresses applied by the sleeve <NUM> on the struts 112a, 112b.

<FIG> illustrate views of one embodiment of a resilient sleeve <NUM>, which is similar to sleeve <NUM> of <FIG>. Sleeve <NUM> is shown to include a unitary body <NUM> having a bore <NUM> extending therethrough configured for rotary actuation of the sleeve <NUM>. The bore <NUM> may include a threaded internal surface that interacts with threads of a shaft supported by an apex of the frame (not shown) to translate a distal end <NUM> of the sleeve <NUM> over struts of a frame as described with regard to <FIG>.

In some embodiments an example of a sleeve may have a length LSLEEVE (Height) of <NUM>" and width WSLEEVE of <NUM>" although it is appreciated that the length and width of the sleeve are a matter of design and relate to an architecture of the frame.

According to one aspect, the actuator sleeve may include a resiliency feature such as sleeve slot <NUM> configured to distribute contact point stress more effectively along the implant. For example, the resiliency feature may be configured to increase the contact surface area between the sleeve <NUM> and struts 112a, 112b (<FIG>) by enabling the sleeve <NUM> to more effectively deform over the struts.

Sleeve slot <NUM> may extend partially or fully through the body <NUM> of the sleeve into the bore <NUM>. Alternatively, a sleeve slot may extend internally from the bore through or partially through the body <NUM> to a sleeve surface. The sleeve slot <NUM> comprises a length LSLOT and a width WSLOT. In <FIG>, the sleeve slot <NUM> apportions at least a front face of sleeve <NUM> into two legs 204a, 204b. In various embodiments, the length LSLOT of the sleeve slot <NUM> may extend from between <NUM>%-<NUM>%, or <NUM>%-<NUM>% of a length LSLEEVE of the sleeve <NUM>. In some embodiments, the length LSLOT may extend along all or a portion of the sleeve <NUM> that covers the proximal apex of the frame when the sleeve <NUM> is translated to a distal-most extent, for example where a distal end <NUM> of sleeve <NUM> contacts a flange <NUM> (<FIG>) of the frame. In an exemplary embodiment, where the length LSLEEVE of a sleeve <NUM> is <NUM>-<NUM>, and the sleeve <NUM> is configured to travel <NUM>-<NUM> over the proximal apex of the frame, the length LSLOT may range between <NUM>-<NUM> and the width WSLOT may range between <NUM>-<NUM>. Although the sleeve slot <NUM> is shown to be generally rectangular, there is no limit to the shape of the slot <NUM>, and, for example, slot shapes that are sinusoidal, zig-zag, dashed, angular, repetitive, semi-repetitive, etc. are also encompassed by the present disclosure. Although in <FIG> the sleeve slot <NUM> is shown to extend through the distal end <NUM> of the sleeve <NUM>, it is not a requirement. Rather, it is appreciated that embodiments of a sleeve <NUM> in which a sleeve slot <NUM> does not extend through a distal end of the sleeve may include fewer sharp edges.

The width WSLOT of the sleeve slot <NUM> may be selected based on one or more considerations including, but not limited to, the width of the struts, the spacing between struts, the form of actuation (which may relate to features within the bore <NUM>), the material of the frame, the material of the sleeve, etc. In some embodiments, the width WSLOT may vary over the length LSLOT, for example to form a triangular shape, a semi-circular shape, diamond shape, or other cut-out type pattern. According to one aspect, the sleeve slot <NUM> may impart a resiliency to the sleeve <NUM>, enabling a degree of expansion and contraction of the sleeve to dampen and/or distribute the forces applied to the frame by the sleeve to mitigate against fracture risk.

It is recognized that the exact form (in terms of length, width, etc.) of a resiliency feature may vary in accordance with design considerations such as frame material, sleeve material, actuation type, frame design, implant location, etc. In general, the resiliency feature is selected to allow the sleeve to perform its intended function of engaging and retaining the frame while reducing the chronic impact of such engagement.

In accordance with the invention, a sleeve <NUM> incorporates multiple different resiliency features. For example, <FIG> illustrate perspective views of a sleeve <NUM> having multiple sleeve slots 322a, 322b, 322c, and 322d, each sleeve slot disposed on a different surface 321a, 321b, 321c, and 321d of the sleeve <NUM>. Although four sleeve slots 322a-322d are shown, it is appreciated that resiliency features may be disposed upon any portion or surface of a sleeve that experiences chronic contact with the frame. In some embodiments, it may be advantageous to provide slots on opposing surfaces of the sleeve, such as sleeve slot 322a on sleeve surface 321a, and slot 322c on surface 321c. Although the slots 322a, 322b, 322c, and 322d are shown as substantially similar in <FIG>, it is appreciated that the particular resiliency feature selected may vary based upon the form of contact between the frame and the sleeve at the particular position. For example, in some embodiments in accordance with the invention, sleeve slots 322b and 322d on the sides of the sleeve <NUM> may be shorter than sleeve slots 322a and 322c to retain sleeve integrity and cinching ability of the side faces 321b and 321d, while relatively longer slots 322a, 322c would enable deformity of the sleeve <NUM>.

<FIG> illustrates an embodiment of a sleeve <NUM> including a plurality of sleeve slots, such as sleeve slot <NUM>, extending through a surface <NUM> of the sleeve. The sleeve slots <NUM> apportion the distal end <NUM> of the sleeve <NUM> into a plurality of tabs, such as tab <NUM>. Although the sleeve slots <NUM> are shown of uniform length, it is not a requirement, and it is appreciated that in some embodiments in accordance with the invention the lengths of the slots <NUM> vary, for example tapering from longer slots disposed on a central portion of the surface <NUM>, with a slot length tapering to shorter slots along the edges of the sleeve or visa-versa. Although only one surface is shown in <FIG>, it is appreciated that a similar or different pattern of slots may be provided on other surfaces of the sleeve <NUM>. In addition, although the width and spacing of slots <NUM> is shown to be relatively uniform, in various embodiments in accordance with the invention, the width and spacing of slots <NUM> vary, resulting in tabs <NUM> having different widths to provide different degrees of deformity therebetween.

<FIG> illustrate another embodiment of a resilient sleeve <NUM>. In <FIG>, a front surface <NUM> and two side surfaces 520a, 520b of the sleeve <NUM> can be seen. According to one aspect, the resiliency feature of sleeve <NUM> includes a window <NUM> cut through the front surface and/or rear surface of the sleeve <NUM>, the window defining a pair of arms 502a, 502b that extend along the side surfaces 520a, 520b of the sleeve <NUM> to its distal end <NUM>. In essence, the window <NUM> is a wide slot that extends across or partially across the front surface <NUM> and/or rear surface (not shown) of the sleeve. According to one aspect, the arms 502a, 502b of sleeve <NUM> absorb the pressure exerted by the sleeve <NUM> on the frame during use.

For example, <FIG> is a 'heat map' of the sleeve <NUM> intended to illustrate the strain experienced by the arms 502a, 502b of the sleeve <NUM> when the arms 502a, 502b are deflected away from a central longitudinal axis of the sleeve as a result of distal translation of the sleeve <NUM> over the struts. The lighter the color, the greater the strain experienced at that location of the arms 502a, 502b. It can be seen in <FIG> that the strain, rather than occurring at a single point of the sleeve, is distributed along the arms 502a, 502b. The flexibility of the arms 502a, 502b thus allows them to flex outwardly as they contact the struts to soften the contact edge and associated strain between the sleeve <NUM> and the struts during use. In some embodiments, softer, more elastic arms 502a, 502b may deform over the struts, increasing contact surface area to more effectively distribute stress during use.

<FIG> illustrates a portion of a frame <NUM> showing the sleeve <NUM> in use, where the sleeve <NUM> has been distally translated over struts 512a, 512b to pull together the struts 512a, 512b and the anchors 510a, 510b. As shown in <FIG>, as the sleeve <NUM> is translated distally, the arms 502a, 502b ride along the respective struts 512a, 512b, deforming the distal end of the sleeve <NUM> in accordance with a shape of the frame. As a result, the stresses are distributed more evenly along arms 502a, 502b, and the potential for fatigue over time is reduced. Although not required, in some embodiments the arms 502a, 502b may be coated on an internal surface with a smooth polymer or other material to further reduce the impact of friction and abrasion of the frame by the arms 502a, 502b.

Referring now to <FIG>, it is recognized that in use an annular implant experiences chronic torsion and other three-dimensional stresses caused by movement of the heart muscle. <FIG> illustrates one embodiment of a resilient sleeve <NUM> including a helical sleeve slot <NUM> which extends through or partially through sleeve body <NUM> and is circumferentially disposed about a distal end <NUM> of sleeve <NUM>. According to one aspect, the helical slot may be used to dampen three-dimensional stresses. In one embodiment, the helical sleeve slot <NUM> initiates at an entry point <NUM> of the sleeve <NUM> and extends proximally at an angle relative to an axis defined by a distal end <NUM> of the sleeve. The helical sleeve slot <NUM> may continue about the sleeve <NUM> for a number of turns, until disposed about an extent <NUM> of the sleeve <NUM>, essentially transforming the distal end <NUM> of the sleeve <NUM> into a helical coil that is expandable in at least three dimensions along the extent <NUM>. Thus, in the embodiments of <FIG>, because the helical slot <NUM> is disposed about the circumference of the sleeve, the overall length of the helical slot <NUM>, from entry point <NUM> to terminating cut, may exceed the length of the sleeve <NUM>. In addition, helical slots having similar extents may vary in length depending upon the pitch of the helical cut. In various embodiments of resilient sleeves including helical slots <NUM>, the extent <NUM> may vary from between <NUM>%-<NUM>%, or <NUM>%-<NUM>% of a length of the sleeve <NUM>.

In some embodiments the helical slot may extend partially around or fully around the sleeve. In some embodiments, the helical slot may extend around the sleeve for multiple turns. In some embodiments, the helical slot may be continuous or alternatively may be noncontinuous (dashed). In some embodiments, the helical slot may cut through an external surface of the sleeve, but not an internal surface of a sleeve bore. In some embodiments, the helical slot may cut through the internal surface of the sleeve bore, but not through the external surface of the sleeve. In some embodiments the helical slot may vary in pitch as it ascends/descends along the sleeve <NUM>.

<FIG> illustrates the distal end <NUM> of the sleeve <NUM> in more detail. In some embodiments, because a helical slot <NUM> initiates with an angular cut at initiation point <NUM> into or through the surface <NUM> of the sleeve <NUM>, and because the angled cut may undesirably provide a sharp edge to the implant, a dulling feature, such as divot <NUM>, may be provided to minimize contact between sharp edges and annular tissue. Other methods for softening the edge, such as cutting in perpendicularly before starting the helix, or starting the helix by cutting through the surface without creating an edge, etc., could readily be substituted herein by those of skill in the art.

<FIG> illustrates a portion of an implant <NUM> including a frame <NUM> having a sleeve <NUM> distally advanced over struts 612a, 612b. As shown in <FIG>, the helical slots <NUM> enable the distal end of the sleeve <NUM> to conform in shape to the struts 612a, 612b. As a result, the three-dimensional torsion forces are distributed to minimize the potential for fatigue of frame <NUM>.

<FIG> illustrate an alternate embodiment of a sleeve <NUM> including a combination of resiliency features such as a sleeve slot <NUM> as well as several cutouts, such as cutout <NUM>. For the purposes of this description, a cutout is a cut through or partially through a surface <NUM> of the sleeve <NUM>, wherein at least a portion of sleeve material is removed, and/or a thickness of the sleeve is otherwise varied. In <FIG>, the cutouts are shown to extend circumferentially around the sleeve <NUM>. In some embodiments, the cutouts may extend partially around the sleeve <NUM>, or be provided as individual holes or other form of cutout that are disposed at various locations on various surfaces of the sleeve <NUM> that may benefit from increased flexibility. Although <FIG> illustrate cutouts from an external surface of sleeve <NUM>, in other embodiments, cutouts may also or alternatively be disposed upon the internal surface, such as the bore wall.

<FIG> is a representative illustration of sleeve <NUM> in use, for example where the sleeve <NUM> has been advanced over a proximal apex of a frame such that arms 722a, 722b of the sleeve are spread apart as they ride over the frame. As shown in <FIG>, the cutout <NUM> changes the thickness of the sleeve <NUM> for the extent of the cutout <NUM>, thereby increasing the flexibility and/or deformability of the sleeve <NUM> at the cutout <NUM>. While the cutouts <NUM> are shown of uniform spacing and pattern, it is appreciated that in various embodiments the cutouts may vary in size, width or spacing to compensate for the particular forces experienced by the frame. For example, in some embodiments, cutouts that are more closely spaced may provide sleeve portions of added flexibility, while cutouts that are spaced farther apart may provide more rigidity to the sleeve structure.

Various methods for modifying sleeve resiliency using slots or other cutouts have been described. According to one aspect, sleeve resiliency may be further improved by changing the composition of the sleeve. For example, in various embodiments the resiliency characteristics of a sleeve may be improved by manufacturing the sleeve at least in part using resilient materials having an increased elasticity and ability to more easily deform over the struts to more effectively distribute sleeve forces. Such materials include, but are not limited to, Nitinol, cobalt chrome, stainless steel, titanium, and the like.

In some embodiments, the sleeve may be made of a single material with increased resilience. In other embodiments, the sleeve may be manufactured to include multiple materials that vary in resilience. For example, <FIG> is a drawing of a sleeve <NUM> that has been shaded such that portions of the sleeve manufactured from materials having a lower resilience are darker than those portions of the sleeve having a higher resilience. For example, the portion <NUM> of the sleeve that supports the drive shaft may have a higher stiffness to facilitate operation of the drive shaft, and a lower stiffness, or increased flexibility to enable the distal end <NUM> to facilitate deformation of the distal end <NUM> over struts.

In some embodiments, the sleeve may be formed of graphene, and/or a polymer that may be coated with a solid coating such as graphite and/or a drug eluting coating. The body of the sleeve may comprise a braided coil tube, like a catheter, encompassed in a polymer sheath. Some embodiments may comprise a braid disposed over a coil, the combination encapsulated by a polymer. Alternatively, a braided sheath encapsulating a threaded inner component that is a molded, thermoformed component may be used. Furthermore, a coiled, reinforced sheath that incorporates the threaded inner bore may be used herein.

While it has been described above that different sleeves may be manufactured using different materials to form a unitary body, in other embodiments a sleeve may be formed of multiple materials and/or may be adapted to include additional components to reduce stress at the frame. For example, <FIG> illustrate the introduction of bumpers to a resilient sleeve <NUM>. <FIG> illustrates a distal portion of one embodiment of a resilient sleeve <NUM> having a bore <NUM> extending therethrough. As discussed above, the sleeve <NUM> may experience stress at lower distal corners as indicated by arrows 919a, 919b from chronic contact with struts during use, and bumpers <NUM>, <NUM> may be configured to dampen the impact of the chronic contact.

<FIG> illustrates a distal end of the sleeve <NUM> in more detail. Bumper <NUM> is preferably formed of a material that is softer and/or more resilient than that of sleeve <NUM>. For example, bumper <NUM> may be made of a softer material such as a polymer that conforms to the strut without leaving particulate to reduce abrasion that may lead to fatigue. In some embodiments the bumper <NUM> may comprise an internal bore coating that is integral with the sleeve <NUM>. In other embodiments, the bumper <NUM> may be comprised of a discrete component that may be press fit into the bore <NUM> of the sleeve <NUM> during the manufacturing process. For example, each bumper <NUM> may include a nub or tab <NUM> that may be press fit into a hole or recess <NUM> within the bore <NUM> of the sleeve <NUM>.

<FIG> is a cross section taken along line 9C-9C of <FIG>. As shown in <FIG>, a bumper <NUM>, <NUM> may be disposed on opposing sides of the bore <NUM>, in particular where the frame (not shown) contacts the internal surface of the bore <NUM> during use. The size, position and shape of the bumpers <NUM>, <NUM> may vary in accordance with the particular shape of the frame and the contact points between the frame and the sleeve <NUM>. Although two bumpers are shown, it is appreciated that the number of bumpers is not so limited, and that various combinations of coatings and/or bumpers disposed at contact points within a bore may advantageously reduce frame fatigue to maintain frame integrity during use.

Accordingly, various embodiments of annular valve implants providing customizable valve shaping with resilient actuator sleeves have been shown and described. Such implants may be part of a valve annulus reshaping system <NUM> such as that shown in <FIG> which is shown to include a deployment catheter <NUM> having a distal tip <NUM> comprising a distal sheath <NUM> and an extendable guidewire <NUM> extending therethrough to guide the deployment catheter <NUM> into position proximate to a valve annulus <NUM>. Deployment catheter <NUM> may measure about twenty to thirty centimeters in length for accessing the atrium <NUM> and the mitral valve annulus <NUM> through the apex of the heart. Deployment catheter <NUM> may access the vasculature of the leg, in particular the femoral vein or the iliac vein for transluminal deployment to a cardiac annulus.

An implant <NUM> including actuator sleeves having one or more resiliency features such as those disclosed herein may be disposed within the distal sheath <NUM> of the deployment catheter during deployment.

<FIG> illustrates a deployment system <NUM> that may be used to deploy an implant <NUM> for annular reshaping as described herein. The deployment system <NUM> comprises a steerable sheath <NUM>, a sheath steering knob <NUM>, cinch knobs <NUM>, anchor knobs <NUM>, the implant <NUM>, and a visualization probe <NUM>, supported by a base <NUM>. The cinch knobs <NUM> and anchor knobs <NUM> may be spring loaded to maintain tension. Cinch knobs <NUM> may be manipulated by an operator to compress an expandable frame, to anchor the frame, and/or to reduce a valve annulus by advancing the resilient actuator sleeves along the struts.

It should be noted that, although the disclosure has focused on the use of actuator sleeves that are rotatably driven over a frame, the principles disclosed herein are not limited to use with rotating actuators. Other actuation sleeves, including sleeves that are pushed or otherwise ratcheted down over frame struts to adjust strut spacing may similarly benefit from the inclusion of resiliency features such as those described herein. For example, the principles disclosed herein may also improve the fatigue tolerance for implants such as those disclosed, for example, in <CIT> (issued on <CIT>); as described, for example, in <CIT> (issued on <CIT>); as described, for example, in <CIT> (issued on <CIT>); as described, for example, in <CIT> (issued on <CIT>); as described, for example, in <CIT> (issued on <CIT>), and/or as described, for example, in <CIT> (issued on <CIT>). Thus, the description of particular features and functionalities herein is not meant to exclude other features and functionalities.

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. Thus, the disclosure is not intended to be limited to the implementations shown 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. 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.

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:
An implant (<NUM>) comprising:
a frame (<NUM>, <NUM>) having a proximal end, a distal end and adjacent struts (<NUM>, <NUM>) joined at an apex (<NUM>); and
a sleeve (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) disposed about the apex, the sleeve configured to apply a force to the frame at one or more contact points along the adjacent struts, the sleeve including a resiliency feature selected to reduce stress resulting from the force at the one or more contact points,
wherein the sleeve includes a plurality of sleeve slots (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) extending from a distal end of the sleeve proximally for a slot extent, characterized in that at least two of the plurality of sleeve slots differs by at least one of a length, a width, extent, or a pattern.