Strain relief sleeves for cardiovascular devices

Abstract

The actuation sleeve includes elastic features that can reduce long-term strain on the annulus implant. The elastic features can be related to one or more of the sleeve's material, manufacturing, size, and / or design attributes. In one aspect, the elastic features can allow the sleeve to deform at the frame connection interface to distribute forces and thereby reduce frame fatigue.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority under 35 U.S.C. 119 to U.S. Provisional Patent Application No. 62 / 871,791, filed on July 9, 2019, which is incorporated herein by reference in its entirety for all purposes. Technical Field

[0003] The present disclosure relates generally to the field of implantable medical devices and, more particularly, to implantable devices, systems, and methods for modulating cardiac structures. Background Art

[0004] The mitral valve is located between the left atrium and left ventricle of the heart. It consists of anterior and posterior leaflets that coapt during systole. The mitral annulus is a saddle-shaped fibrous ring surrounding the mitral valve and supporting the leaflets. Mitral regurgitation (MI) is a form of heart disease in which the mitral annulus becomes excessively dilated and the leaflets no longer coapt effectively during systole. Regurgitation occurs during ventricular contraction, and cardiac output decreases.

[0005] Annuloplasty is performed to restore the mitral valve's ability to close by restoring the physiologic shape and function of the normal mitral valve. Annuloplasty involves the implantation of a structure (e.g., a ring, stent, frame, etc.) within the heart. Cardiac implants are subject to the long-term stresses and strains associated with myocardial palsy, and it would be desirable to reduce the effects of these long-term forces on cardiac implants. Summary of the Invention

[0006] Embodiments of the present disclosure relate to a valve annulus implant comprising elastic components configured to reduce the effects of long-term stress on the implant during use. According to one aspect, the implant includes a frame having a proximal end, a distal end, and adjacent struts connected at an apex. The implant may also include a sleeve disposed around the apex, the sleeve configured to apply force to the frame at one or more contact points; the sleeve including an elastic characteristic selected to reduce stress caused by the force at the one or more contact points. The elastic characteristic may comprise one of the sleeve material and / or sleeve design. The sleeve material may comprise one or more of nickel-titanium alloy, stainless steel, a polymer, a cobalt-chromium alloy, or other similar materials. In some embodiments, the sleeve material may have different elasticity and / or resilience at different locations within the sleeve. Alternatively, the sleeve may comprise a sleeve body having an aperture extending therethrough, the sleeve material being a composite material comprising a first material disposed within the aperture and a second material disposed at least partially around the aperture. The second material may have a lower elasticity than the first material. The first material may cover at least a portion of the aperture proximate to at least one contact point. Alternatively, the first material may include a shock absorber fixedly attached to a location in the hole proximate to at least one contact point. Additionally or alternatively, the cannula design may include one or more cannula slots. The cannula slot may extend proximally from the distal end of the cannula by a slot span (slot extent). The width of the cannula slot may vary along the slot span. The cannula slot may be greater than half the cannula width. Additionally or alternatively, the cannula slot may extend longitudinally along the cannula or helically around the cannula by a slot span. The cannula slot may extend helically around the cannula for one or more turns. The cannula slot may have a varying pitch over the one or more turns. Additionally, the implant may include multiple cannula slots. At least two of the multiple cannula slots may be arranged on opposite sides of the cannula or on the same side of the cannula. At least two of the multiple cannula slots may have different slot spans.

[0007] According to another aspect, the implant delivery system comprises a delivery catheter and a framework, and the framework has a compression configuration for advancing to the valve annulus through the delivery catheter and an expanded configuration for the framework to be placed in a position close to the valve annulus for repair. The framework may comprise a proximal end, a distal end, and adjacent struts connected at the apex portion and an actuator comprising a sleeve arranged around the apex portion, the actuator being configured to drive the sleeve on the apex portion by pushing or rotating the actuator in order to compress the framework into a tightened configuration, wherein force is applied to adjacent struts to regulate the spacing between adjacent struts. The sleeve may comprise an elastic feature, which comprises a sleeve composition or a sleeve design for reducing the force applied to the framework by the sleeve.

[0008] According to yet another aspect, a method for placing an implant to change the shape of a valve annulus at the annulus site includes the steps of placing an implant at the annulus site; the implant comprising a frame including a pair of struts connected at an apex, and an actuator comprising a sleeve disposed near the apex. The method includes compressing the frame into a contracted configuration (wherein force is applied to adjacent struts to adjust the spacing between adjacent struts) by pushing or rotating the actuator, wherein actuating the actuator causes the sleeve to at least partially deform to reduce the force applied by the sleeve to the frame.

[0009] Due to this arrangement, the elastic characteristics can reduce the risk of fracture by reducing the effects of long-term stress and strain on the frame. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] Non-limiting embodiments of the present disclosure are described below by way of example and with reference to the accompanying drawings, which are schematic and not intended to be drawn to scale. In the drawings, each identical or nearly identical illustrated component is generally represented by a single numeral. For clarity, not every component is labeled in every drawing, nor is every component of each embodiment shown, where such illustration is not necessary for one skilled in the art to understand the disclosure. In the drawings:

[0011] Figure 1A An implant including an elastically actuated sleeve according to one embodiment of the present disclosure is shown;

[0012] Figure 1B Shown Figure 1A part of the framework of the implant;

[0013] Figure 2A and Figure 2B are front and perspective views of one embodiment of an elastic sleeve according to the present disclosure;

[0014] Figure 3A and Figure 3B is a perspective view of one embodiment of an elastic sleeve according to the present disclosure;

[0015] Figure 4 One embodiment of an elastic sleeve according to the present disclosure is shown;

[0016] Figures 5A-5C shows a perspective view of one embodiment of an elastic sleeve according to the present disclosure;

[0017] Figures 6A-6C shows a perspective view of one embodiment of an elastic sleeve according to the present disclosure;

[0018] Figure 7A and Figure 7B One embodiment of an elastic sleeve according to the present disclosure is shown;

[0019] Figure 8 One embodiment of an elastic sleeve according to the present disclosure is shown;

[0020] Figure 9A and Figure 9B shows a perspective view of one embodiment of an elastic sleeve according to the present disclosure, Figure 9C An embodiment of an elastic sleeve according to the present disclosure is shown along Figure 9A A sectional view taken along line 9C-9C;

[0021] Figure 10 shows an exemplary delivery system that may be suitable for use with embodiments of implants according to the present disclosure; and

[0022] Figure 11 Shown Figure 10 Other components of the placement system. DETAILED DESCRIPTION

[0023] An annuloplasty implant may include components that interact and may experience fatigue during long-term operation of the implant. According to one aspect, an improved annuloplasty implant includes one or more resilient components for reducing deleterious effects of component interactions. In one embodiment, an actuation sleeve for tightening the implant may be configured with at least one resilient feature to enhance the ability of the actuation sleeve to absorb stresses and strains resulting from the actuation sleeve / frame interaction. In various embodiments, the resilient feature may be related to one or more of the material, manufacturing, size, and / or design attributes of the actuation sleeve. In some embodiments, the resilient feature may increase the elasticity of the actuation sleeve at the contact point to absorb stresses. Alternatively, or in combination, the resilient feature may increase the deformability of the actuation sleeve, thereby increasing the contact surface area to better distribute stresses along the sleeve.

[0024] These and other advantageous aspects of the elastic sleeve and methods of manufacture and / or use are described in greater detail below. It should be noted that while embodiments of the present disclosure are described with particular reference to the mitral valve, the principles disclosed herein can be readily modified to facilitate reconstruction of any valve annulus, including, for example, the tricuspid valve annulus and / or can similarly be beneficial for any other dilatation, valvular insufficiency, valvular leakage, and other similar heart failure conditions.

[0025] As used herein, the term "distal" refers to the end farthest from the medical professional when the medical device is introduced into the patient, while the term "proximal" refers to the end closest to the medical professional when the medical device is introduced into the patient.

[0026] Figure 1AAn implant 100 is shown that includes a frame 120 disposed around a valve 150. The frame 120 of the implant 100 supports an actuator 113 and anchors 110a, 110b, wherein not all components of the implant are numbered for clarity. In one embodiment, the frame 120 may extend circumferentially around and partially along a central frame axis (which extends proximally-distally through a center point of the frame) such that the anchors 110a, 110b disposed at distal ends of the frame 120 are located proximal to the valve annulus 155. The frame 120 may be generally symmetrical relative to the central frame axis, although it need not be symmetrical. The frame 120 may be formed into a generally tubular shape, wherein "tubular" herein includes circular and other looped or closed shapes. The frame 120 may be configured to vary in shape, size, and / or configuration. For example, the frame 120 may assume various shapes, sizes, configurations, etc. during different stages of deployment (eg, pre-delivery, delivery, tissue engagement, and cinching).

[0027] According to one embodiment, the frame 120 may be formed of one or more struts 112a, 112b, and 112c, which may constitute all or part of the frame 120, wherein the struts 112a, 112b, and 112c may include elongated structural members, which are made of metal alloys, shape memory materials (such as nickel-titanium or other metal alloys), metal alloys, plastics, polymers, composite materials, other suitable materials, or combinations thereof. Figure 1A Fourteen struts are shown in FIG, although it will be appreciated that in some embodiments there may be fewer or more than fourteen struts.

[0028] In one embodiment, the struts of framework 120 can be made of identical single piece material (for example tubing). Therefore, the reference to struts 112a, 112b and 112c can refer to the different parts of identical large parts. Alternatively, the reference to struts 112a, 112b and 112c can refer to the parts that are independently formed and permanently attached together (example by welding or other methods). In certain embodiments, struts 112a, 112b and 112c can be independent parts that are separably coupled together to form proximal apex and distal apex. For example, struts 112a, 112b are illustrated in their proximal ends to form proximal apex, and wherein actuator 113 is assembled on the apex. Struts 112b and 112c are connected at their distal ends, and wherein anchor 110b is coupled to their distal ends.

[0029] In some embodiments, the terms "apex," "apex portions," and the like, as used herein and as used in any reference incorporated herein by reference, may be used interchangeably with the terms "top," "crowns," and the like, unless otherwise indicated. In one embodiment, the "apex portion" may include the proximal or distal portion of the frame. For example, Figure 1B A portion of the frame 120 is shown with the actuator removed to expose the proximal apex 170 of the frame 120. The proximal apex 170 may include the portion of the frame where the struts 112a, 112b are adjacent, and the distal apex 180 may include the portion of the frame where the struts 112b and 112c are adjacent. The apex may also include portions of the frame that may be constrained by structure that is adjacent to the struts to form the apex. For example, the distal apex 180 includes portions of the struts 112b, 112c that have openings that support the anchor 110b. The proximal apex 170 includes portions of the struts 112a, 112b that are configured to support an actuator (not shown) and includes portions of the struts 112a, 112b along which the actuator can travel. Figure 1B In the embodiment shown, each strut includes a flange (such as flange 121) configured to limit the range of distal travel of the actuator, and thus the proximal apex portion 170 includes the portion of the strut extending from the flange 121 to the proximal tips 172a, 172b of the struts 112a, 112b. Figure 1B In an embodiment, the proximal apex portion 170 of the frame 120 is arranged to form a window (crenel, notch) 175 that is configured to carry the head of the actuator shaft. Other embodiments in which the frame is oriented so that the anchor is positioned more proximally than the cannula so that the distal apex portion carries the cannula and the proximal apex portion carries the anchor are also within the scope of the present disclosure.

[0030] Reference again Figure 1A In one embodiment, the actuator 113 includes an actuator shaft 115 rotatably carried by the proximal end of the frame 120, for example, the head of the actuator shaft 115 may be carried by the window 175 of the proximal apex portion 170 of the frame 120 ( Figure 1B ). The sleeve 114 may include internal features (internal structure) that are configured to interact with features of the actuator shaft 115 such that rotation of the actuator shaft 115 by a drive shaft (not shown) coupled to the drive coupling 118 causes the sleeve 114 to translate axially on the actuator shaft 115 and on (along) the struts 112a, 112b. In some embodiments, the term "axial" as applied to axial movement or constraint of the sleeve includes a direction at least partially in the proximal or distal direction and parallel or substantially parallel to a central axis extending through (e.g., proximally-distally) the frame. Figure 1A As shown in FIG, struts 112a and 112b extend in opposite directions away from the proximal apex portion. Distal advancement of sleeve 114 over struts 112a, 112b pulls the struts together within the sleeve and thereby reduces the distance between anchors 110a, 110b to change the shape of annulus 155 surrounding valve 150. In one embodiment, each sleeve 114 can be independently actuated, depending on the purpose of the shape change of the associated anchor pair. When each sleeve has been actuated to deploy its associated anchor pair, a drive shaft (not shown) coupled to drive coupling 118 can be released from the implant.

[0031] According to one aspect, each sleeve 114 may include one or more elastic features that are configured to reduce the effects of long-term contact between the sleeve 114 and the struts 112a, 112b. Such elastic features may reduce the pressure exerted by the sleeve 114 on the struts at the edge contact points (such as at the pressure point P1 of the strut 112a) when the sleeve 114 is translated distally on the strut 112a. In the absence of such elastic features, the pressure P1 results in stress at the stress point S1 of the strut 112a, which may cause fatigue of the frame 120 over time. The elastic features may increase the elasticity and / or deformation of the sleeve 114 to reduce the effects of the pressure P1 and the associated stress S1. For example, in Figure 1A As shown in FIG, the sleeve 114 includes a sleeve window (notch) 130 that enables the sleeve 114 to deform at its distal end to relieve stress applied by the sleeve 114 to the struts 112a, 112b.

[0032] Figure 2A-2B Shows something like Figure 1A 14. The sleeve 200 is shown as comprising a unitary body 210 having a bore 205 extending therethrough for rotational actuation of the sleeve 200. The bore 205 may include a threaded inner surface that interacts with threads of a shaft supported by a frame apex (not shown) to allow translation of a distal end 207 of the sleeve 200 on a strut of the frame, as described with respect to FIG. Figure 1A described.

[0033] In some embodiments, one example of a cannula may have a length (height) L of 0.300". 套管 (L sleeve ) and 0.100" width W 套管 (W sleeve ), although it will be appreciated that the length and width of the sleeve is a matter of design and is related to the construction of the frame.

[0034] According to one aspect, the actuation sleeve can include an elastic feature (e.g., sleeve groove 202) configured to more effectively distribute contact point stresses along the implant. For example, the elastic feature can be used to increase the contact surface area between the sleeve 200 and the struts 112a, 112b ( FIG. 1 ) by enabling the sleeve 114 to more effectively deform on the struts.

[0035] The sleeve slot 202 may extend partially or completely through the body 210 of the sleeve into the hole 205. Alternatively, the sleeve slot may extend internally from the hole or partially through the body 210 to the sleeve surface. The sleeve slot 202 includes a length L 槽 (L slot ) and width W 槽 (W slot ).exist Figure 2A In the embodiment, the sleeve slot 202 divides at least the front face of the sleeve 200 into two legs 204a, 204b. In various embodiments, the length L of the sleeve slot 202 is 槽 Can extend up to the length L of the sleeve 200 套管 In some embodiments, the length L 槽 The sleeve 200 may extend along all or part of the sleeve 200 when the sleeve 200 is translated to its most distal extent, such as where the distal end 207 of the sleeve 200 is aligned with the flange 121 ( Figure 1B ) contact, the sleeve 200 covers the proximal apex portion of the frame. In an exemplary embodiment, the length L of the sleeve 200 is 套管 6-12 mm, and the cannula 200 is configured to travel 3-8 mm on the proximal apex portion of the frame, the length L 槽 Can be in the range of 1-4mm and width W 槽 It can be in the range of 0.25-2 mm. Although the sleeve groove 202 is shown to be generally rectangular, there is no limitation on the shape of the groove 202, and the present disclosure also includes groove shapes such as sinusoidal, zigzag, discontinuous, angular, repeated, semi-repeated, etc. Although in Figure 2A and Figure 2B 20. The cannula slot 202 is shown extending through the distal end 207 of the tube 200, but this is not required. Conversely, it should be understood that various embodiments of the cannula 200 in which the cannula slot 202 does not extend through the distal end of the cannula may include fewer sharp edges.

[0036] The width W of the sleeve slot 202 may be selected based on one or more considerations including, but not limited to, the width of the struts, the spacing between the struts, the type of actuation (which may be related to the characteristics of the interior of the hole 205), the material of the frame, the material of the sleeve, etc. 槽 In some embodiments, the width W 槽 Available in length L槽 The sleeve groove 202 may be configured to change in shape, for example, to form a triangular shape, a semicircular shape, a diamond shape, or other shear-type patterns. According to one aspect, the sleeve groove 202 may impart elasticity to the sleeve 200, thereby enabling the sleeve to expand and contract to a certain extent to weaken and / or distribute the force applied by the sleeve to the frame to reduce the risk of breakage.

[0037] It is generally recognized that the specific form of the elastic feature (in terms of length, width, etc.) can vary depending on design considerations such as frame material, sleeve material, actuation type, frame design, implant location, etc. Generally speaking, the elastic feature is selected to allow the sleeve to perform its intended function of engaging and retaining the frame while reducing the long-term effects of such engagement.

[0038] According to one aspect, the sleeve 200 is not limited to a single elastic feature but may include multiple similar or different elastic features. For example, Figure 3A and Figure 3B A perspective view of a sleeve 320 is shown having a plurality of sleeve grooves 322a, 322b, 322c, and 322d, each of which is disposed on a different surface 321a, 321b, 321c, and 321d of the sleeve 320. Although four sleeve grooves 322a-322d are shown, it should be understood that the resilient feature may be disposed on any portion or surface of the sleeve that experiences prolonged contact with the frame. In some embodiments, it may be advantageous to provide grooves on opposing surfaces of the sleeve, such as sleeve groove 322a on sleeve surface 321a and groove 322c on surface 321c. Although in Figure 2A and Figure 2B 322d are shown as being generally similar, but it should be understood that the specific elastic characteristics selected may vary based on the form of contact between the frame and the sleeve at a particular location. For example, in some embodiments, the sleeve grooves 322b and 322d on the side of the sleeve 320 may be shorter than the sleeve grooves 322a and 322c to maintain the integrity of the sleeve and the tightening ability of the sides 321b and 321d, while the relatively longer grooves 322a and 322c will allow the sleeve 320 to deform.

[0039] Figure 4 One embodiment of a cannula 400 is shown that includes a plurality of cannula grooves (e.g., cannula grooves 402) extending through a cannula surface 410. The cannula grooves 402 divide the distal end 407 of the cannula 400 into a plurality of tabs (e.g., tabs 404). Although the cannula grooves 402 are shown as having a uniform length, this is not required, and it should be understood that in some embodiments the length of the grooves 402 may vary, such as tapering from longer grooves disposed on a central portion of the surface 410 to shorter grooves along the edges of the cannula, or vice versa. Although Figure 44. Only one surface is shown in the drawings, but it should be understood that similar or different patterns of grooves (groove patterns) may be arranged on other surfaces of the sleeve 400. Additionally, while the width and spacing of the grooves 402 are shown as being relatively uniform, in various embodiments, the width and spacing of the grooves 402 may vary, thereby forming protrusions (tabs) 404 having different widths to provide different degrees of deformation therebetween.

[0040] Figures 5A-5C Another embodiment of an elastic sleeve 500 is shown. Figure 5A , the front surface 510 and two side surfaces 520a, 520b of the cannula 500 can be seen. According to one aspect, the resilient feature of the cannula 500 includes a window 515 cut through the front and / or back surfaces of the cannula 500, which defines a pair of arms 502a, 502b extending along the side surfaces 520a, 520b of the cannula 500 to its distal end 507. In essence, the window 515 is a wide slot extending across or partially across the front and / or back surfaces of the cannula (not shown). According to one aspect, the arms 502a, 502b of the cannula 500 absorb pressure applied by the cannula 500 to the frame during use.

[0041] For example, Figure 5B is a "heat map" of the cannula 500 that illustrates the strain experienced by the arms 502a, 502b of the cannula 500 as the arms 502a, 502b deflect in a direction away from the cannula's central longitudinal axis due to distal translation of the cannula 500 on (along) the strut. The lighter the color, the greater the strain experienced at the location of the arms 502a, 502b. Figure 5B In the embodiment of the present invention, it can be seen that the strain does not occur at a single point on the sleeve, but rather is distributed along the arms 502a, 502b. Therefore, the flexibility of the arms 502a, 502b allows them to flex outward when they contact the strut during use to soften the contact edge and the associated strain between the sleeve 500 and the strut. In some embodiments, the softer, more resilient arms 502a, 502b can deform on the strut, thereby increasing the contact surface area for more effective distribution (distribution) of stress during use.

[0042] Figure 5C A portion of the frame 505 is illustrated showing the sleeve 500 in use, wherein the sleeve 500 has been translated distally over the struts 512a, 512b to draw the struts 512a, 512b and the anchors 510a, 510b together. Figure 5CAs shown in FIG, when the cannula 500 is translated distally, the arms 502a, 502b follow (ride) their respective struts 512a, 512b, thereby deforming the distal end of the cannula 500 according to the shape of the frame. As a result, these stresses are more evenly distributed along the arms 502a, 502b, which reduces the likelihood of fatigue over time. Although not required, in some embodiments, the inner surfaces of the arms 502a, 502b can be coated with a smooth polymer or other material to further reduce the effects of friction and wear of the arms 502a, 502b on the frame.

[0043] Now refer to Figures 6A-6C It is generally accepted that, in use, annular implants are subjected to long-term torsional and other three-dimensional stresses caused by myocardial motion. Figure 6A One embodiment of an elastic sleeve 600 is illustrated that includes a helical sleeve groove 620 that extends through or partially through the sleeve body 610 and is circumferentially arranged around the distal end 607 of the sleeve 600. According to one aspect, the helical groove can be used to reduce three-dimensional stresses. In one embodiment, the helical sleeve groove 620 begins at an entry point 615 of the sleeve 600 and extends proximally at an angle relative to an axis defined by the distal end 607 of the sleeve. The helical sleeve groove 620 can continue around the sleeve 620 for several turns until arranged approximately a span 605 of the sleeve 600, thereby essentially converting the distal end 607 of the sleeve 600 into a helical coil that can expand in at least three dimensions along the span 605. Thus, in Figures 6A-6C In the embodiment of the present invention, because the spiral groove 620 is arranged around the circumference of the sleeve, the total length of the spiral groove 620 from the entry point 615 to the terminal cut can exceed the length of the sleeve 600. In addition, depending on the pitch of the spiral cut, spiral grooves with similar spans can have different lengths. In various embodiments of the elastic sleeve including the spiral groove 620, the range 605 can vary between 5%-55% or 50%-75% of the length of the sleeve 600.

[0044] In some embodiments, the spiral groove may extend partially around or completely around the sleeve. In some embodiments, the spiral groove may extend around the sleeve for multiple turns. In some embodiments, the spiral groove may be continuous or alternatively may be discontinuous (intermittent). In some embodiments, the spiral groove may cut through the outer surface of the sleeve, but not through the inner surface of the sleeve hole. In some embodiments, the spiral groove may cut through the inner surface of the sleeve, but not through the outer surface of the sleeve. In some embodiments, the pitch of the spiral groove may vary as it rises / falls along the sleeve 600.

[0045] Figure 6BThe distal end 607 of the cannula 600 is shown in greater detail. In some embodiments, because the helical groove 620 begins at a bevel cut at a starting point 615 and enters or passes through the surface 610 of the cannula 600, and because a bevel cut would undesirably expose the implant to a sharp edge, a blunting structure (e.g., dimple 618) may be provided to minimize contact between the sharp edge and the annular tissue. Other methods for softening the edge (e.g., cutting perpendicularly before initiating the spiral, or initiating the spiral by cutting across the surface without forming an edge, etc.) may be readily substituted by one skilled in the art herein.

[0046] Figure 6C A portion of an implant 640 including a frame 633 is shown with the cannula 600 advanced distally over struts 612a, 612b. Figure 6C As shown in FIG, the spiral groove 620 enables the distal end of the sleeve 600 to conform in shape to the struts 612a, 612b. Thus, the three-dimensional torsional forces are distributed to minimize the possibility of fatigue of the frame 633.

[0047] Figure 7A and Figure 7B An alternative embodiment of a sleeve 700 is shown that includes a combination of a resilient feature, such as sleeve groove 710, and a number of undercuts, such as undercut groove 720. For the purposes of this description, an undercut is a groove that passes through or partially through the surface 710 of the sleeve 700, wherein at least a portion of the sleeve material is removed and / or the thickness of the sleeve is changed. Figure 7A and Figure 7B , the undercuts are shown extending circumferentially around the sleeve 700. In some embodiments, the undercuts may extend partially around the sleeve 700, or may be provided as separate holes, or other forms of undercuts arranged at various locations on various surfaces of the sleeve 700, which may benefit from increased flexibility. Figure 7A and Figure 7B The grooves are shown cut from the outer surface of the sleeve 700, but in other embodiments, the grooves can also or alternatively be arranged on the inner surface (such as the wall of the hole).

[0048] Figure 7B is a representative view of the cannula 700 in use, for example wherein the cannula 700 has been advanced over the proximal apex portion of the frame such that the cannula arms 722a, 722b diverge as they ride (straddle) the frame. Figure 7BAs shown in FIG, the slots 720 change the thickness of the sleeve 700 by the range of the slots 720, thereby increasing the flexibility and / or deformability of the sleeve 700 at the slots 720. Although the slots 720 are shown as having a uniform spacing and pattern, it should be understood that in various embodiments the slots may have varying sizes, widths, or spacings to compensate for the specific forces experienced by the frame. For example, in some embodiments, slots that are more closely spaced may provide a sleeve portion with increased flexibility, while slots that are further apart may provide more rigidity to the sleeve structure.

[0049] Various methods for adjusting sleeve elasticity using grooves or other cutouts have been described. According to one aspect, sleeve elasticity can be further improved by varying the sleeve's composition. For example, in various embodiments, the sleeve's elastic properties can be enhanced by at least partially fabricating the sleeve from an elastomeric material that exhibits increased elasticity and the ability to more easily deform over the struts, thereby more effectively distributing sleeve forces. Such materials include, but are not limited to, nickel-titanium alloys, cobalt-chromium alloys, stainless steel, titanium, and the like.

[0050] In some embodiments, the sleeve may be made of a single material having increased resilience. In other embodiments, the sleeve may be made to include multiple materials having varying resilience. For example, Figure 8 8 is a diagram of a cannula 800 that has been shaded so that portions of the cannula made of a material with a lower resilience are darker than portions of the cannula with a higher resilience. For example, the portion 818 of the cannula 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 818 to facilitate deformation of the distal end 819 on the strut.

[0051] In some embodiments, the cannula may be constructed of graphene and / or a polymer that may be covered with a solid coating, such as graphite and / or a drug-eluting coating. The body of the cannula may comprise a braided coil (e.g., a catheter) enclosed within a polymer sheath. Some embodiments may include a combination of a braid disposed over a coil, encapsulated by a polymer. Alternatively, a braided sheath may be used that encapsulates a threaded inner component that is a molded, thermoformed component. Additionally, a coiled, reinforced sheath comprising a threaded inner bore may be used herein.

[0052] Although it has been described above that different sleeves can be made of different materials to form a unitary body, in other embodiments the sleeve can be constructed from multiple materials and / or can be adapted to include other components to reduce stress at the frame. For example, Figures 9A-9C The introduction of a shock absorber into an elastic sleeve 900 is illustrated. Figure 9AThe distal portion of one embodiment of a resilient sleeve 900 is shown having a hole 950 extending therethrough. As described above, the sleeve 900 can be subjected to stresses at the lower distal angles due to prolonged contact with the struts during use, as indicated by arrows 919a, 919b, and shock absorbers 920, 922 can be used to mitigate the effects of prolonged contact.

[0053] Figure 9B The distal end of the cannula 900 is shown in greater detail. The shock absorbers 920 are preferably constructed of a material that is softer and / or more resilient than the material of the cannula 900. For example, the shock absorbers 920 can be made of a softer material, such as a polymer, that conforms to the struts without leaving particles to reduce wear that can lead to fatigue. In some embodiments, the shock absorbers 920 can include an inner bore coating that is integral with the cannula 900. In other embodiments, the shock absorbers 920 can be comprised of separate components that can be press-fitted into the bore 950 of the cannula 900 during the manufacturing process. For example, each shock absorber 920 can include a block or sheet 930 that can be fitted into a small hole or recess 932 within the bore 950 of the cannula 900.

[0054] Figure 9C It is along Figure 9A The cross section is taken by the straight line 29C-9C. Figure 9C As shown in FIG, shock absorbers 920, 922 may be disposed on opposite sides of the aperture 950, particularly where a frame (not shown) contacts the inner surface of the aperture 950 during use. The size, location, and shape of the shock absorbers 920, 922 may vary depending on the specific shape of the frame and the contact points between the frame and the sleeve 900. While two shock absorbers are shown, it should be understood that the number of shock absorbers is not so limited, and various combinations of coatings and / or shock absorbers disposed at contact points within the aperture may advantageously reduce frame fatigue, thereby maintaining frame integrity during use.

[0055] Thus, various embodiments of an annular valve implant that provides customizable annuloplasty for a resiliently actuated sleeve have been disclosed and described. Such an implant can be part of an annular reshaping system 1000, as described in Figure 10As shown in FIG, the annulus reshaping system 1000 is shown to include a placement catheter 1010 having a distal tip 1020 including a distal sheath 1040 and an extendable guidewire 1025 that can be extended through the distal sheath 1040 to guide the placement catheter 1010 to a position proximal to the valve annulus 1060. The placement catheter 1010 can have a length of approximately 20 to 30 centimeters to pass through the apex of the heart and into the atrium 1065 and the mitral valve annulus 1060. The placement catheter 1010 can be accessed through the vasculature of the leg (particularly the femoral vein or iliac vein) for transluminal placement into the heart annulus.

[0056] An implant 1030 can be placed inside a distal sheath 1040 of a delivery catheter during deployment, the implant having a plurality of actuation sleeves having one or more elastic features, as disclosed herein.

[0057] Figure 11 Shown is a delivery system 1100 that can be used to deliver an implant 1101 for annular reshaping, as described herein. The delivery system 1100 includes a steerable sheath 1102 supported by a base 1110, a sheath steering knob 1104, a tightening knob 1106, an anchor knob 1108, the implant 1101, and a visualization probe 1127. The tightening knob 1106 and the anchor knob 1108 are spring-loaded to maintain tension. The tightening knob 1106 can be manipulated by an operator to compress the expandable frame, to anchor the frame, and / or to reduce the valve annulus by causing a resiliently actuated sleeve to travel along the struts.

[0058] It should be noted that although the present disclosure has focused on the use of actuating sleeves that can be rotationally driven over a frame, the principles disclosed herein are not limited to use to rotate actuators. Other actuating sleeves that include sleeves that are pushed over frame struts or released downward to adjust strut spacing may similarly benefit from the inclusion of resilient features as described herein. For example, the principles disclosed herein may also improve the fatigue resistance of implants, as described, for example, in U.S. patent application Ser. No. 14 / 861,877, entitled “Adjustable Intraluminal Implant for Mitral Valve Annulus Reshaping,” filed on September 22, 2015 (issued on April 11, 2017, U.S. Patent No. 9,615,926); for example, in U.S. patent application Ser. No. 15 / 280,004, entitled “Method for Delivering a Heart Valve Using Intravascular Ultrasound Imaging,” filed on September 29, 2016 (issued on July 2, 2019, U.S. Patent No. 10,335,275); for example, in U.S. patent application Ser. No. 15 / 043,301, entitled “Valve Replacement Using a Rotatable Anchor,” filed on February 12, 2016 (issued on December 26, 2017, U.S. Patent No. 9,848,983); for example, in U.S. patent application Ser. No. 15 / 043,301, entitled “Valve Replacement Using a Rotatable Anchor,” filed on February 12, 2016 (issued on December 26, 2017, U.S. Patent No. No. 10,555,813, entitled “Mitral Valve Reversal Prosthesis,” filed on March 12, 2015 (issued on April 4, 2017, U.S. Patent No. 9,610,156), and / or as described, for example, in U.S. patent application No. 15 / 893,122, entitled “Implantable Device and Delivery System for Reshaping a Heart Valve Annulus,” filed on February 9, 2018 (issued on February 4, 2020, U.S. Patent No. 10,548,731), the entire disclosure of each of which is incorporated herein by reference for all purposes and constitutes a part of this specification. Thus, the description herein of specific features and functions is not intended to exclude other features and functions, such as those described in references incorporated herein by reference or otherwise within the scope of the improved approach.

[0059] Those skilled in the art will readily appreciate various modifications to the embodiments described in this disclosure, and the general principles defined herein may be applied to other embodiments without departing from the spirit or scope of this disclosure. Therefore, this disclosure is not intended to be limited to the embodiments disclosed herein, but is to be given the widest scope consistent with the claims, principles, and novel features disclosed herein. The word "example" is used exclusively herein to mean "serving as an example, instance, or illustration." Any embodiment described herein as an "example" is not necessarily to be understood as being preferred or advantageous over other embodiments unless otherwise indicated.

[0060] Certain features described in the context of independent embodiments in this specification may also be implemented in combination in a single embodiment. Conversely, the various features described in the context of a single embodiment may also be implemented independently in multiple embodiments or in any suitable sub-combination form. In addition, although features may be described as working in certain combinations and even initially claimed for patent protection, in some cases one or more features from the claimed combination may be removed from the combination, and the claimed combination may refer to a sub-combination or a variation of the sub-combination. Similarly, although each operation is depicted in a particular order in the accompanying drawings, this should not be understood as requiring such operations to be performed in the particular order shown or in a sequential order, or to perform all of the illustrated operations to obtain the desired result. In addition, other embodiments are also within the scope of the appended claims. In some cases, the operations recited in the claims may be performed in different orders and still obtain the desired result.

[0061] Those skilled in the art will understand that, in general, the terms used herein are generally intended to function as "open-ended" terms (e.g., the term "includes" should be interpreted as "including but not limited to," the term "having" should be interpreted as "having at least"), the term "including" should be interpreted as "including but not limited to," etc.). Those skilled in the art will further understand that if a specific number of adopted claim recitations is intended, such intent will be explicitly recited in the claim, and in the absence of such recitation, such intent is absent. For example, as an aid to understanding, the appended claims may contain the use of the introductory phrases "at least one" and "one or more" to introduce claim recitations. However, the use of such phrases should not be construed to mean that the introduction of a claim recitation with the indefinite article "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 an indefinite article such as "a" or "an" (e.g., "a" and / or "an" should generally be interpreted to mean "at least one" or "one or more"); the same is 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 generally be interpreted to mean at least the recited number (e.g., a recitation of "two recitations" without other modifiers generally means at least two recitations or two or more recitations). Furthermore, where a convention similar to "at least one of A, B, and C, etc." is used, generally, such grammatical construction is intended to have a meaning that one skilled in the art would understand the convention (e.g., "a system having at least one of A, B, and C" would include, but is not limited to, systems having A alone, B alone, C alone, A and B collectively, A and C collectively, B and C collectively, and / or A, B, and C collectively, etc.). Where a convention similar to "at least one of A, B, or C, etc. is used, generally, such grammatical construction is intended to have a meaning that one skilled in the art would understand the convention (e.g., "a system having at least one of A, B, or C" would include, but is not limited to, systems having A alone, B alone, C alone, A and B collectively, A and C collectively, B and C collectively, and / or A, B, and C collectively, etc.). It will be further understood by those skilled in the art that any transitional word and / or phrase that actually gives two or more alternative words, whether in the description, claims, or drawings, should be understood to encompass the possibility of including one, either, or both of these words. For example, the phrase "A or B" will be understood to include the possibility of "A" or B" or "A and B."

[0062] In light of the present disclosure, the apparatus and / or methods disclosed and claimed herein can be made and executed without undue experimentation. Although various embodiments of the apparatus and methods of the present disclosure have been described, it will be apparent to those skilled in the art that variations may be applied to these apparatus and / or methods and the steps or sequence of steps of the methods described herein without departing from the concept, spirit, and scope of the present disclosure. It will be apparent to those skilled in the art that all such similar substitutes and modifications are deemed to be within the spirit, scope, and concept of the present disclosure as defined by the appended claims.

Claims

1. An implant comprising: a frame having a proximal end, a distal end, and adjacent struts connected at an apex; and a sleeve 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 resilient feature selected to reduce stress generated by the force at the one or more contact points, Wherein the sleeve includes a sleeve body having a bore extending therethrough, and the sleeve includes a first material disposed within the bore and a second material disposed at least partially around the bore.

2. The implant of claim 1, wherein the sleeve comprises a sleeve material comprising one or more of a polymer, nickel titanium alloy, stainless steel, graphene, and cobalt chromium alloy.

3. The implant of claim 2, wherein the deformability of the sleeve material varies along the length of the sleeve.

4. The implant of claim 1, wherein the second material has a lower elasticity than the first material.

5. The implant of claim 1 or 4, wherein the first material covers at least a portion of the hole proximate to at least one contact point.

6. The implant of claim 4, wherein the first material comprises a shock absorber fixedly attached to at least a portion of the aperture proximate at least one contact point.

7. The implant of claim 1 or 4 or 6, wherein the sleeve comprises a sleeve slot.

8. The implant of claim 7, wherein the sleeve slot extends proximally from the distal end of the sleeve a slot span.

9. The implant of claim 8, wherein the sleeve slot has varying widths across the slot span.

10. The implant of claim 9, wherein the sleeve has a width and the sleeve slot has a width greater than half the width of the sleeve.

11. The implant of claim 9, wherein the sleeve slot extends longitudinally along a sleeve axis from a distal end of the sleeve toward a proximal end of the sleeve by the slot span.

12. The implant of claim 9 or 10, wherein the sleeve groove extends helically around at least a portion of the sleeve.

13. The implant of claim 8, comprising a plurality of sleeve slots.

14. The implant of claim 13, wherein at least two slots of the plurality of sleeve slots differ in at least one of length, width, span, or pattern.

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