Implantable annulus forming structure adaptive to various annulus sizes

Abstract

The invention relates to an implantable annuloplasty structure adapted to a variety of annulus sizes. An annuloplasty structure (122) includes a body portion (123) and a constricting member (30). The body portion may comprise a flexible material and may be shaped to define one or more controllable expansion sections (40). Each controllable expansion section has a corresponding first length (L1). Each controllable expansion section may be expanded or shrunk to assume a corresponding second length (L2), the corresponding second length (L2) being different from the corresponding first length. A contraction member is coupled to the body portion and configured to contract the body portion independent of a mechanism to expand the controllable expansion section. Other embodiments are also described.

Description

[0001] This application is a divisional application. The filing date of the original application is May 21, 2019, the application number is 201980041632.3, and the invention title is "Implantable Annuloplasty Structures Adaptable to Multiple Annular Sizes", which is hereby incorporated by reference in its entirety.

[0002] Cross - reference to related applications

[0003] This application claims the priority of U.S. Provisional Patent Application 62 / 676,145, filed on May 24, 2018, by Peleg et al.; and the priority of U.S. Provisional Patent Application 62 / 720,392, filed on August 21, 2018, by Peleg et al. Each of the above - mentioned applications is hereby incorporated by reference into this application. Technical Field

[0004] Some applications generally relate to valve repair, for example, the repair of atrioventricular valves in a patient. Some applications relate to minimally invasive valve repair and / or trans - catheter valve repair. Background Art

[0005] Ischemic heart disease can cause mitral regurgitation through the combination of ischemic dysfunction of the papillary muscles, left ventricular dilation present in ischemic heart disease, subsequent papillary muscle displacement, and mitral annulus dilation.

[0006] The dilation of the mitral annulus prevents the valve leaflets from fully co - apting during valve closure. Mitral regurgitation of blood from the left ventricle to the left atrium results in an increase in total stroke volume and a decrease in cardiac output, as well as successive left atrial volume overload and pressure overload, and ultimately left ventricular weakening. Various problems can also occur with regurgitation at the tricuspid valve and other valves. Summary of the Invention

[0007] This summary section is intended to provide some examples and is not intended to limit the scope of the invention in any way. For example, any feature included in the examples of this summary section is not claimed by the claims unless the claim explicitly defines that feature. In addition, the features, components, steps, concepts, etc. described in the examples of this summary section and in other parts of this disclosure can be combined in various ways. The description herein relates to systems, assemblies, methods, devices, equipment, combinations, etc. that can be used to repair valves such as the mitral valve or tricuspid valve. The various features and steps described in other parts of this disclosure can be included in the examples of this summary section. The methods, operations, steps, etc. described herein can be performed on live animals or non - live cadavers, cadaver hearts, mock - ups (e.g., having simulated body parts, tissues, etc.).

[0008] In some applications, systems or devices are provided that include an implant structure that includes an annuloplasty structure or annuloplasty ring structure configured to fit all or a variety of different annulus sizes. Various systems, devices, and methods are described that enable minimally invasive and / or trans-luminal (e.g., trans-catheter, trans-vascular, etc.) annuloplasty structures to be positioned along the annulus without pre-measuring the annulus size. In this way, the systems and devices described herein can accommodate and fit all annulus sizes of any patient or most annulus sizes of most patients.

[0009] The implant structure can include at least a portion of the annuloplasty structure (e.g., an annuloplasty ring structure, a partial annuloplasty ring, a complete annuloplasty ring, an annuloplasty band, etc.) for repairing an enlarged annulus of a patient's native atrioventricular valve (such as the mitral valve or tricuspid valve).

[0010] For some applications, such as the elongated annuloplasty structure described above, it is positioned trans-luminally along the annulus and sequentially attached (e.g., anchored, fastened, clamped, adhered, etc.) to the annulus. In such applications, the elongated annuloplasty structure can be longer than required for a given annulus, and thus, the elongated annuloplasty structure includes a device or feature that enables shortening of the total length of the elongated annuloplasty structure while maintaining the integrity of the main body portion (body portion) of the annuloplasty structure (e.g., by not cutting or severing any part of the main body portion). For some applications, the elongated annuloplasty structure is delivered to the annulus in an elongated state, partially attached (e.g., anchored, etc.) to the annulus, and then shortened after attachment. For some applications, the elongated annuloplasty structure is shortened (e.g., compressed) in conjunction with the anchoring process, e.g., alternating between shortening and attachment.

[0011] For some applications, the annuloplasty structure is partially controllably expandable. For such applications, the annuloplasty structure is delivered to the annulus in a shortened state, partially expanded, and subsequently attached (e.g., anchored, etc.) to the annulus. For some applications, the expansion of the annuloplasty structure is combined with attachment. For example, in such applications, the annuloplasty structure includes a plurality of attachment segments or anchoring segments that are alternately arranged with a plurality of controllably expandable segments. The controllably expandable segments are controllably expandable by one or more control wires.

[0012] Accordingly, systems or devices including an annuloplasty structure are provided for certain applications. The annuloplasty structure includes a body portion (such as an annuloplasty ring body portion, an annuloplasty body portion, etc.), which includes a flexible material. In some applications, the body portion is shaped and / or configured to define one or more controllable expansion segments, each of the one or more controllable expansion segments having a corresponding first length. In some applications, the body portion includes one or more control filaments coupled to the one or more controllable expansion segments, the one or more control filaments being movable to facilitate expansion of each of the one or more controllable expansion segments to present a corresponding second length, the corresponding second length being greater than the corresponding first length. The system, device, and / or annuloplasty structure also includes a contraction member and / or a contraction mechanism or attachment mechanism that includes and / or is coupled to the contraction member. The contraction member is coupled to the body portion and is configured to contract the body portion independent of the one or more control filaments.

[0013] In some applications, each of the one or more controllable expansion segments constitutes a portion of the flexible material of the body portion, the portion being folded, and wherein the one or more control filaments pass through the fold of the portion.

[0014] In some applications, the portion is telescopically folded in a direction away from the longitudinal axis of the body portion at the portion.

[0015] In some applications, the portion is folded in such a way that at least one pocket is formed between the layers of the fold of the portion, and the pocket has a certain longitudinal length, the longitudinal length being measured along a pocket axis that is generally parallel to the longitudinal axis of the body portion at the portion.

[0016] In some applications, the one or more control filaments are removably coupled to the one or more controllable expansion segments, and the flexible material is biased such that after the one or more control filaments are decoupled from the one or more controllable expansion segments, the one or more controllable expansion segments expand.

[0017] In some applications, the one or more control filaments are fixedly attached to the one or more controllable expansion segments, and the one or more control filaments facilitate expansion of the one or more controllable expansion segments in response to pulling on the one or more control filaments.

[0018] In some applications, the one or more controllable expansion segments include a plurality of controllable expansion segments.

[0019] In some applications, the one or more control filaments comprise exactly one control filament that controls all of the plurality of controllable expansion segments.

[0020] In some applications, the one or more control filaments comprise a plurality of control filaments, each of the plurality of control filaments being movable to facilitate expansion of a corresponding one of the plurality of controllable expansion segments.

[0021] According to some applications, a method is further provided that includes delivering an annuloplasty structure to an annulus of a patient's heart valve. The annuloplasty structure can be the same as or similar to the annuloplasty structures described above or elsewhere herein. For example, in some applications, the annuloplasty structure includes a body portion (e.g., an annuloplasty ring body portion, etc.), the body portion including a flexible material, the body portion being shaped and / or configured to define one or more controllable expansion segments, each of the one or more controllable expansion segments having a corresponding first length. The annuloplasty structure includes one or more control filaments coupled to the one or more controllable expansion segments, the one or more control filaments being movable to expand each of the one or more controllable expansion segments such that a corresponding second length is presented, the corresponding second length being greater than the corresponding first length. The annuloplasty structure includes a contraction member and / or a contraction mechanism or attachment mechanism that includes and / or is coupled to the contraction member, the contraction member being coupled to the body portion and configured to cause the body portion to contract independently of the one or more control filaments. The method further includes controllably expanding the one or more controllable expansion segments by moving the one or more control filaments. This method can be performed on a live animal or a non-living cadaver, cadaver heart, simulator, anthropomorphic ghost, etc.

[0022] In some applications, the one or more control filaments are removably coupled to the one or more controllable expansion segments, the flexible material being biased such that the one or more controllable expansion segments expand after removal of the one or more control filaments, and controllably expanding includes decoupling the one or more control filaments from the one or more controllable expansion segments. In some applications, the one or more control filaments are fixedly attached to the one or more controllable expansion segments, and controllably expanding includes pulling on the one or more control filaments.

[0023] In some applications, the one or more control filaments comprise exactly one control filament that controls all of the plurality of controllable expansion segments, and controllably expanding the one or more controllable expansion segments includes controllably expanding the plurality of controllable expansion segments by gradually moving exactly the one control filament.

[0024] According to some applications, methods are also provided, including delivering an annuloplasty structure to the annulus of a patient's heart valve, the annuloplasty structure including a body portion comprising a flexible material, the body portion being shaped and / or configured to define a first controllable expansion section and a second controllable expansion section, each of the first controllable expansion section and the second controllable expansion section having a corresponding first length. The method includes: controllably expanding at least the first controllable expansion section to a second length, the second length being greater than the first length; and fixing the second controllable expansion section to maintain the first length and prevent the second controllable expansion section from expanding. This method can be performed on a living animal or a non-living cadaver, cadaver heart, simulator, anthropomorphic phantom, etc.

[0025] In some applications, fixing the second controllable expansion section includes driving a tissue anchor through the material of the second controllable expansion section.

[0026] In some applications, the method further includes contracting the body portion after fixing the second controllable expansion section.

[0027] Each of the first controllable expansion section and the second controllable expansion section may include a corresponding portion of the flexible material of the body portion, the corresponding portion being folded.

[0028] According to some applications, methods are further provided, including delivering an annuloplasty structure to the annulus of a patient's heart valve, the annuloplasty structure including a body portion. The body portion may include a flexible material. In some embodiments, the method includes: using an anchor delivery system to anchor a first section of the body portion to the tissue of the annulus using a first tissue anchor. The method may further include: after anchoring, using the anchor delivery system to compress a second section of the body portion toward the first section of the body portion. The method may further include: after compression of the second section, using the anchor delivery system to drive a second tissue anchor through the body portion and into the tissue of the annulus, and by driving the second tissue anchor, maintaining the compression of the second section of the body portion. This method can be performed on a living animal or a non-living cadaver, cadaver heart, simulator, anthropomorphic phantom, etc.

[0029] In some applications, compressing the second section of the body portion includes reversibly engaging the anchor delivery system with the second section.

[0030] In some applications, driving the second tissue anchor through the body portion includes driving the second tissue anchor through the second section of the body portion.

[0031] In some applications, after maintaining the compression of the second section, the body portion is contracted using a contraction member coupled to the flexible material of the body portion.

[0032] According to some applications, a system and / or device is also provided, which includes an annuloplasty structure (e.g., an annuloplasty ring structure, etc.), and the annuloplasty structure includes a body portion (e.g., an annuloplasty ring body portion, etc.). In some applications, the body portion is shaped and / or configured to define a plurality of compressible segments, each of the plurality of compressible segments having a first thickness. The body portion may also be shaped and / or configured to include a plurality of anchor - specifying segments, each of the plurality of anchor - specifying segments having a second thickness, and the second thickness is greater than the first thickness of the corresponding one of the plurality of compressible segments. The plurality of anchor - specifying segments may be arranged alternately with the plurality of compressible segments, and each anchor - specifying segment is designated for delivering a corresponding tissue anchor therethrough. In some applications, a contraction member is coupled to the body portion, and the contraction member is configured to cause the body portion to contract. The plurality of compressible segments of the flexible material may facilitate a reduction in the total compressive force on the flexible material of the body portion during the contraction of the body portion by the contraction member.

[0033] In some applications, the first thickness is 0.05 - 0.1 mm. In some applications, the second thickness is 0.15 - 0.2 mm. In some applications, the body portion includes a fabric.

[0034] In some applications, each of the plurality of compressible segments is shaped and / or configured to define a window.

[0035] In some applications, the body portion includes at least one flexible material that defines the plurality of compressible segments and the plurality of anchor - specifying segments.

[0036] In some applications, the body portion includes:

[0037] At least one first flexible material that defines the plurality of compressible segments; and at least one second flexible material that defines the plurality of anchor - specifying segments.

[0038] In some applications, each of the plurality of compressible segments is shaped and / or configured to define a compressible segment wall, and the compressible segment wall has a first thickness.

[0039] In some applications, each of the plurality of anchor - specifying segments is shaped and / or configured to define an anchor - specifying wall, and the anchor - specifying wall has a second thickness.

[0040] According to some applications, systems and / or devices are also provided, including an annuloplasty structure (e.g., an annuloplasty ring structure, etc.). The annuloplasty structure can be the same as or similar to the structures described above or in other parts of this document. For example, in some applications, the annuloplasty structure includes a body portion (e.g., an annuloplasty ring body portion, etc.), the body portion having first and second body portion ends and including a flexible material. The flexible material of the body portion can be shaped and / or configured to define an anchoring member coupling region or an attachment region between the first body portion end and a location near the body portion between the first and second body portion ends (excluding the second body portion end). In some applications, the flexible material of the body portion is also shaped and / or configured to define a deformable region between the second body portion end and a location near the body portion between the first and second body portion ends (excluding the first body portion end). The deformable region can be deformable in the absence of a force applied thereto and can be deformable to shorten the total length of the body portion.

[0041] In some applications, the system and / or device further includes a constriction member coupled to the body portion, the constriction member being configured to constrict at least the anchoring member coupling region or the attachment region of the body portion.

[0042] In some applications, in the absence of a force applied to the deformable region, the deformable region is capable of deforming into a helical configuration.

[0043] In some applications, the deformable region includes nitinol, and the nitinol is configured to facilitate the deformation of the deformable region.

[0044] In some applications, when a tube is disposed at least through the lumen of the deformable region, the deformable region assumes a linear configuration.

[0045] In some applications, the tube constitutes an anchoring member delivery system.

[0046] According to some applications, methods are additionally provided, including delivering an annuloplasty structure (e.g., an annuloplasty ring structure, etc.) to the annulus of a patient's heart valve. The annuloplasty structure can be the same as or similar to other annuloplasty structures described above or in other parts of this document. For example, in some applications, the annuloplasty structure includes a body portion (e.g., an annuloplasty ring body portion, etc.), the body portion having first and second body portion ends and including a flexible material. In some applications, the flexible material of the body portion is shaped and / or configured to define an anchoring member coupling region or attachment region between the first body portion end and a location near the body portion between the first and second body portion ends (excluding the second body portion end). In some applications, the flexible material of the body portion is shaped and / or configured to define a deformable region between the second body portion end and a location near the body portion between the first and second body portion ends (excluding the first body portion end). The deformable region can be deformable in the absence of a force applied thereto and can be deformed to shorten the total length of the body portion. This method can be performed on a living animal or a non-living cadaver, cadaver heart, simulator, anthropomorphic phantom, etc.

[0047] In some applications, the method further includes anchoring the anchoring member coupling region or attachment region to the annulus when the deformable region presents a first shape. The method can include, after anchoring, allowing the deformable region to deform and present a second shape in the absence of a force applied thereto.

[0048] In some applications, the method further includes, after allowing the deformable region to deform, contracting the body portion.

[0049] According to some applications, systems and / or devices are additionally provided, including an annuloplasty structure (e.g., an annuloplasty ring structure, etc.). The annuloplasty structure can be the same as or similar to other annuloplasty structures described above or in other parts of this document. For example, the annuloplasty structure can include a body portion (e.g., an annuloplasty ring body portion, etc.), the body portion including a flexible material that includes a plurality of intertwined fibers. The body portion has a longitudinal axis.

[0050] In some applications, the body portion has at least a first longitudinal section that includes a first portion of the plurality of intertwined fibers oriented at an angle of 20 - 70 degrees relative to the longitudinal axis of the body portion. In some applications, the body portion also has a second portion of the plurality of intertwined fibers oriented at an angle of 110 - 160 degrees relative to the longitudinal axis of the body portion.

[0051] In some applications, the body portion has at least a second longitudinal section adjacent to the first longitudinal section, the second longitudinal section including:

[0052] The third portion of the plurality of intertwined fibers oriented at an angle of 0-15 degrees relative to the longitudinal axis of the body portion.

[0053] The fourth portion of the plurality of intertwined fibers oriented at an angle of 75-90 degrees relative to the longitudinal axis of the body portion.

[0054] In some applications, the compressibility of the first longitudinal section is greater than that of the second longitudinal section.

[0055] In some applications, the system and / or device further includes at least one tissue anchor, and the second longitudinal section is designated for coupling the at least one tissue anchor thereto.

[0056] According to some applications, a method is further provided, including delivering an annuloplasty structure (e.g., an annuloplasty ring structure, etc.) to the annulus of a patient's heart valve, the annuloplasty structure including a body portion having opposite first and second ends. In some applications, the maximum cross-sectional measurement of the first end is greater than that of the second end. The method includes attaching (e.g., anchoring, etc.) the annuloplasty structure to the annulus. After attachment, the method may include folding the second end toward the first end. This method can be performed on a living animal or a non-living cadaver, cadaver heart, simulator (e.g., where the annulus is a simulated annulus, etc.), anthropomorphic phantom, etc.

[0057] In some applications, the body portion is shaped and / or configured to define a cavity, and folding the second end includes pushing the second end into the cavity toward the first end.

[0058] In some applications, the maximum cross-sectional measurement of the first end is 4 to 6 mm.

[0059] In some applications, the maximum cross-sectional measurement of the second end is 3.0 to 3.9 mm.

[0060] According to some applications, methods are also provided, including delivering an annuloplasty structure (e.g., an annuloplasty ring structure, etc.) to the annulus of a patient's heart valve. The annuloplasty structure can be similar to other annuloplasty structures described herein. In some applications, the annuloplasty structure includes a body portion (e.g., an annuloplasty ring body portion, etc.), the body portion can include a flexible material, and the body portion has a first longitudinal length during delivery; and a contraction member coupled to the body portion, the contraction member being configured to cause the body portion to contract. In some applications, the method further includes: after delivery, causing at least a portion of the body portion to shorten to a second longitudinal length shorter than the first longitudinal length without relying on the contraction member while maintaining the overall integrity of the body portion; and after shortening, reshaping the annulus by causing the body portion to contract using the contraction member. In some applications, the method further includes anchoring the body portion to the annulus. This method can be performed on a living animal or a non-living cadaver, cadaver heart, simulator, anthropomorphic phantom, etc.

[0061] In some applications, causing the portion of the body portion to shorten includes causing the portion of the body portion to shorten before anchoring. In some applications, causing the portion of the body portion to shorten includes: causing the portion of the body portion to shorten progressively with anchoring, the anchoring being performed by: using an anchor delivery system to drive an anchor through a first section of the body portion to anchor the first section to the annulus, and subsequently using the anchor delivery system to compress a second section of the body portion toward the first section of the body portion.

[0062] In some applications, causing the portion of the body portion to shorten includes causing the portion of the body portion to shorten after anchoring.

[0063] In some applications, causing the portion of the body portion to shorten after anchoring includes causing a deformable region of the body portion to assume a deformed shape.

[0064] In some applications, causing the portion of the body portion to shorten includes folding a second end of the body portion toward a first end of the body portion.

[0065] In some applications, the body portion is shaped and / or configured to define a cavity, and folding includes pushing the second end toward the first end into the cavity.

[0066] According to some applications, systems and / or devices are also provided, which include an annuloplasty structure (e.g., an annuloplasty ring structure, etc.). The annuloplasty structure includes a body portion (e.g., an annuloplasty ring body portion, etc.). The body portion can include a first flexible material.

[0067] In some embodiments, the body portion is shaped and / or configured to define a plurality of windows in the body portion or in the flexible material of the body portion. In some embodiments, the body portion is shaped and / or configured to define a plurality of anchoring member designated sections in or of the body portion. The plurality of anchoring member designated sections may be arranged alternately with the plurality of windows, and each anchoring member designated section is designated for delivering a corresponding tissue anchoring member therethrough.

[0068] The system / device may further include a plurality of covers, the covers including a second flexible material, and each of the plurality of covers covers a corresponding one of the plurality of windows. The system / device may further include a shrinkage member coupled to the body portion and the plurality of covers, the shrinkage member being configured to shrink the body portion, and the plurality of windows in the flexible material facilitate a reduction in the total compressive force along the body portion on the flexible material of the body portion during the shrinking of the body portion by the shrinkage member.

[0069] In some applications, each of the plurality of windows is shaped and / or configured to define a longest dimension of 12-16 mm.

[0070] In some applications, the first flexible material has a first thickness, and wherein the second flexible member has a second thickness, and the first thickness is greater than the second thickness.

[0071] In some applications, the first thickness is 0.05-0.1 mm. In some applications, the second thickness is 0.15-0.2 mm.

[0072] In some applications, the second flexible material includes:

[0073] a first portion of the plurality of intertwined fibers oriented at an angle of 20-70 degrees relative to the longitudinal axis of the body portion; and

[0074] a second portion of the plurality of intertwined fibers oriented at an angle of 110-160 degrees relative to the longitudinal axis of the body portion.

[0075] In some applications, the first flexible material includes:

[0076] a third portion of the plurality of intertwined fibers oriented at an angle of 0-15 degrees relative to the longitudinal axis of the body portion; and

[0077] a fourth portion of the plurality of intertwined fibers oriented at an angle of 75-90 degrees relative to the longitudinal axis of the body portion.

[0078] According to some applications, methods are also provided, including delivering an annuloplasty structure (e.g., an annuloplasty ring, an annuloplasty ring structure, etc.) to the annulus of a patient's heart valve, the annuloplasty structure including a body portion (e.g., an annuloplasty ring body portion, etc.). The body portion may include a first flexible material. In some applications, the body portion is shaped and / or configured to define a plurality of windows in the flexible material; and a plurality of designated segments of the flexible material for anchoring members, the plurality of designated segments for anchoring members being arranged alternately with the plurality of windows, each designated segment for an anchoring member being designated for delivering a corresponding tissue anchoring member therethrough. The annuloplasty structure may further include a plurality of covers, the covers including a second flexible material, each of the plurality of covers covering a corresponding one of the plurality of windows. In some applications, a contraction member is coupled to the body portion, the contraction member being configured to contract the body portion, and the plurality of windows in the flexible material facilitate a reduction in the total compressive force on the flexible material of the body portion during contraction of the body portion by the contraction member. The method may further include contracting the body portion using the contraction member. This method can be performed on a living animal or a non-living cadaver, cadaver heart, simulator, anthropomorphic phantom, etc.

[0079] According to some applications, systems and / or devices are additionally provided, which include an annuloplasty structure (e.g., an annuloplasty ring structure, etc.) having a longitudinal axis. The annuloplasty structure includes a primary body portion. In some embodiments, the annuloplasty structure further includes one or more connecting segments removably coupled to the primary body portion.

[0080] In some embodiments, the annuloplasty structure further includes: a first coupling member coupled to a first end of the primary body portion, and a second coupling member coupled to a first end of a first connecting segment among the one or more connecting segments, the first connecting segment being disposed adjacent to the first coupling member at the first end of the primary body portion, and the first coupling member and the second coupling member being shaped and / or configured to cooperate with each other.

[0081] In some embodiments, the annuloplasty structure further includes an anti-disconnection element longitudinally extending along at least the first coupling member and the second coupling member to prevent disconnection of the first coupling member and the second coupling member. Removal of the anti-disconnection element from at least the first coupling member and the second coupling member can facilitate disconnection of the first coupling member and the second coupling member.

[0082] In some applications, the primary body portion is flexible. In some applications, the one or more connecting segments are flexible.

[0083] In some applications, the system and / or device further includes an elongate contraction member extending along the longitudinal length of the primary body portion and along the one or more connecting segments.

[0084] In some applications, the anti-disconnection element includes an elongate shrinkage member extending along the longitudinal length of the main body portion and the one or more connection segments.

[0085] In some applications, the system and / or device further includes a shrinking mechanism coupled to the implant structure and configured to shrink at least a portion of the implant structure.

[0086] In some applications:

[0087] The first coupling member is shaped and / or configured to define a first cavity and includes one or more radially movable protrusions that are radially movable in response to a force applied thereto, and

[0088] The second coupling member is shaped and / or configured to define a second cavity and a negative space that is shaped to receive the one or more radially movable protrusions.

[0089] In some applications:

[0090] The first coupling member is shaped and / or configured to define a first cavity and includes one or more radially movable protrusions that are biased to radially collapse inwardly in the absence of a force applied thereto;

[0091] The second coupling member is shaped and / or configured to define a second cavity and a negative space that is shaped and / or configured to receive the one or more radially movable protrusions; and

[0092] The anti-disconnection element includes an elongate tube configured to maintain the one or more radially movable protrusions within the negative space of the second coupling member when a portion of the elongate tube passes through the corresponding first and second cavities of the first and second coupling members to prevent disconnection of the first and second coupling members.

[0093] In some applications, the elongate tube forms part of an anchor delivery system, and the anchor delivery system is configured to deploy tissue anchors through the one or more connection segments.

[0094] In some applications:

[0095] The one or more connection segments include at least a first connection segment and at least a second connection segment,

[0096] The first connection segment includes a third coupling member coupled to the second end of the first connection segment,

[0097] The second connecting segment includes a fourth coupling member coupled to the first end of the second connecting segment disposed adjacent to the first connecting segment, the fourth coupling member being shaped and / or configured to mate with the third coupling member.

[0098] The anti-disconnection element extends longitudinally through at least the third coupling member and the fourth coupling member to prevent disconnection of the third coupling member and the fourth coupling member, and

[0099] Removal of the anti-disconnection element from at least the third coupling member and the fourth coupling member facilitates disconnection of the third coupling member and the fourth coupling member.

[0100] In some applications:

[0101] The third coupling member is shaped and / or configured to define a third cavity and includes one or more radially movable protrusions that are biased to radially collapse inwardly in the absence of a force applied thereto;

[0102] The fourth coupling member is shaped and / or configured to define a fourth cavity and a negative space that is shaped and / or configured to receive the one or more radially movable protrusions;

[0103] The elongated tube of the anti-disconnection element is configured to maintain the one or more radially movable protrusions of the third coupling member within the negative space of the fourth coupling member when a portion of the elongated tube passes through the corresponding third cavity and fourth cavity of the third coupling member and the fourth coupling member to prevent disconnection of the third coupling member and the fourth coupling member.

[0104] In some applications, the elongated tube forms part of an anchor delivery system, and the anchor delivery system is configured to deploy a tissue anchor through the second connecting segment.

[0105] According to some applications, methods are also provided that include delivering an annuloplasty structure (e.g., an annuloplasty ring structure, etc.) to a patient's heart, the annuloplasty structure having a longitudinal axis. The annuloplasty structure includes a main body portion. In some embodiments, the annuloplasty structure further includes one or more connecting segments removably coupled to the main body portion. In some embodiments, the annuloplasty structure further includes a first coupling member coupled to a first end of the main body portion and a second coupling member coupled to a first end of a first connecting segment among the one or more connecting segments, the first connecting segment being disposed adjacent to the first coupling member at the first end of the main body portion. The first coupling member and the second coupling member can be shaped and / or configured to mate with each other. The annuloplasty structure may further include an anti-disconnection element longitudinally extending along at least the first coupling member and the second coupling member to prevent disconnection of the first coupling member and the second coupling member. In some embodiments, the method further includes facilitating disconnection of the first coupling member and the second coupling member by removing the anti-disconnection element from at least the first coupling member and the second coupling member. This method can be performed on a living animal or a non-living cadaver, cadaver heart, simulator, anthropomorphic phantom, etc.

[0106] In some applications, the method further includes attaching (e.g., anchoring, etc.) the main body portion to heart tissue before facilitating disconnection. In some applications, the method further includes causing at least the main body portion to contract.

[0107] In some applications, facilitating disconnection of the first coupling member and the second coupling member includes applying a force to one or more radially movable protrusions. In some applications, applying a force to one or more radially movable protrusions includes applying a pulling force to the one or more connecting segments.

[0108] In some applications, removing the anti-disconnection element includes moving the radially movable protrusion out of the negative space of the second coupling member.

[0109] According to some applications, systems and / or devices are also provided that include an annuloplasty structure. The annuloplasty structure includes a body portion. In some embodiments, the body portion is shaped and / or configured to define a first segment having a first stretchability and a second segment having a second stretchability, the second stretchability being greater than the first stretchability. The annuloplasty structure may further include a contraction member coupled to the body portion, the contraction member being configured to cause the body portion to contract, and the body portion promotes a reduction in the total compressive force on the flexible material of the body portion during contraction of the body portion by the contraction member.

[0110] In some applications, the second segment is disposed contiguously to the first segment. In some applications, the elasticity of the first segment is different from the elasticity of the second segment.

[0111] In some applications, the first segment is configured to be implanted near the anterolateral commissure between the annulus of a patient's heart valve and P2, and the second segment is configured to be implanted between P2 and the posterolateral commissure.

[0112] In some applications, the first segment has a maximum first diameter, and the second segment has a second diameter that is less than the first diameter after the second segment is stretched.

[0113] According to some applications, a method is further provided that includes delivering an annuloplasty structure to the annulus of a patient's heart valve. The annuloplasty structure includes a body portion. In some embodiments, the body portion is shaped and / or configured to define a first segment having a first stretchability and a second segment having a second stretchability that is greater than the first stretchability. In some embodiments, the annuloplasty structure further includes a constriction member coupled to the body portion, the constriction member being configured to constrict the body portion, and the body portion promotes a reduction in the total compressive force on the flexible material of the body portion during the constriction of the body portion by the constriction member. The method may further include fixing the first segment to the annulus. The method may further include: after fixing the first segment, stretching the second segment; and subsequently, fixing the second segment to the annulus. This method can be performed on a live animal or a non-living cadaver, cadaver heart, simulator, phantom, etc.

[0114] In some applications, fixing the first segment includes driving a tissue anchor through the material of the first segment.

[0115] In some applications, fixing the second segment includes driving a tissue anchor through the material of the second segment.

[0116] In some applications, the method further includes constricting the body portion after fixing the second segment.

[0117] In some applications, the first segment has a first diameter, and stretching the second segment includes stretching the second segment to a second diameter that is less than the first diameter.

[0118] According to some applications, a method is further provided that includes delivering an annuloplasty structure to an annulus of a patient's heart valve, the annuloplasty structure including a body portion. The method may further include driving a first tissue anchor through the body portion of the annuloplasty structure. The method may further include positioning a first section of the body portion along the annulus, the first section of the body portion having a first length. In some embodiments, the method further includes fixing the first section of the body portion to the annulus by driving a second tissue anchor at a first distance from the first tissue anchor. The method may further include: exposing a second section of the body portion, the second section having a second length that is less than the first length of the first section of the body portion; and stretching the second section of the body portion to a stretched state of the second section. The stretched state of the second section may have a third length that is greater than the second length of the second section before stretching. The method may further include: positioning the stretched second section of the body portion along the annulus; and fixing the stretched second section of the body portion to the annulus by driving a third tissue anchor at a second distance from the second tissue anchor, the second distance being equal to the first distance. This method can be performed on a living animal or a non-living cadaver, cadaver heart, simulator (e.g., where the annulus is a simulated annulus, etc.), anthropomorphic phantom, etc.

[0119] In some applications, the method further includes releasing the first section of the body portion from a delivery tool before positioning the first section of the body portion along the annulus, and exposing the second section of the body portion includes releasing the second section of the body portion from a delivery system.

[0120] In some applications, the first section has a first stretchability, and the second section has a second stretchability that is greater than the first stretchability.

[0121] In some applications, the method further includes contracting the body portion after the second section is fixed.

[0122] According to some applications, a system and / or device is further provided that includes an annuloplasty structure, the annuloplasty structure including a body portion. In some embodiments, the body portion is shaped and / or configured to define a first section, and at least one telescoping second section is configured to be at least partially disposed within a cavity of the first section, the at least one telescoping second section being movable proximally and distally along a longitudinal axis of the body portion.

[0123] The annuloplasty structure may further include a contraction member coupled to the body portion, the contraction member being configured to contract the body portion, and during the process of contracting the body portion by the contraction member, promoting a reduction in the total compressive force on the flexible material of the body portion.

[0124] In some applications, the second segment is disposed adjacent to the first segment. In some applications, the first segment is configured to be implanted near the anterolateral commissure between the annulus of a patient's heart valve and P2, and the second segment is configured to be implanted between P2 and the posterolateral commissure.

[0125] In some applications, the at least one telescoping second segment includes at least a first telescoping segment and a second telescoping segment disposed adjacent to each other, the second telescoping segment being configured to be at least partially disposed within the lumen of the first telescoping segment, and the second telescoping segment being movable proximally and distally along the longitudinal axis of the body portion.

[0126] In some applications, the first segment includes a first coupling element, and the at least one telescoping second segment includes a second coupling element, and the first coupling element and the second coupling element are configured to be coupled together after the at least one telescoping second segment has moved relative to the first segment.

[0127] In some applications, the first segment and the at least one telescoping second segment are shaped and / or configured to define corresponding lumens, and the first coupling element and the second coupling element are annular.

[0128] According to some applications, a method is also provided that includes delivering an annuloplasty structure to the annulus of a patient's heart valve. The annuloplasty structure includes a body portion. The body portion can be shaped and / or configured to define a first segment and at least one telescoping second segment. In some embodiments, the at least one telescoping second segment is configured to be at least partially disposed within the lumen of the first segment, and the at least one telescoping second segment is movable proximally and distally along the longitudinal axis of the body portion. The annuloplasty structure can also include a constriction member coupled to the body portion, the constriction member being configured to constrict the body portion, and the body portion during constriction of the body portion by the constriction member facilitating a reduction in the total compressive force on the flexible material of the body portion. The method can also include fixing the first segment to the annulus. In some embodiments, after the first segment is fixed, the method includes moving the at least one telescoping second segment along the longitudinal axis; and subsequently, fixing the at least one telescoping second segment to the annulus. This method can be performed on a live animal or a non-living cadaver, cadaver heart, simulator (e.g., where the annulus is simulated, etc.), anthropomorphic phantom, etc.

[0129] In some applications, fixing the first segment includes driving a tissue anchor through the material of the first segment.

[0130] In some applications, fixing the at least one telescoping second segment includes driving a tissue anchor through the material of the at least one telescoping second segment.

[0131] In some applications, the method further includes contracting the body portion after the at least one telescoping second segment is fixed.

[0132] In some applications, the first segment includes a first coupling element, and the at least one telescoping second segment includes a second coupling element, and the method further includes coupling the first coupling element and the second coupling element together after the at least one telescoping second segment is moved.

[0133] In some applications, the first segment and the at least one telescoping second segment are shaped and / or configured to define corresponding cavities, and the first coupling element and the second coupling element are annular.

[0134] According to some applications, a system and / or device for cardiac tissue of an object is further provided, the system and / or device including an elongate annuloplasty structure. The elongate annuloplasty structure may include a body portion having a wall (which may be flexible). The wall may be a tubular wall defining a cavity along the body portion.

[0135] In some embodiments, the wall includes a sleeve and a helical member, the helical member being stiffer than the sleeve and coupled to the sleeve. The helical member may be configured to define a plurality of helical turns extending along and around the cavity in a helical path.

[0136] In some embodiments, the system and / or device includes a plurality of anchors, each anchor including a head and a tissue engaging element. These may be sized to be advanced along the cavity or the cavity of the wall.

[0137] The system and / or device may include at least one anchor driver. The anchor driver may be configured for each anchor: to reversibly couple the head; to advance the anchor along the cavity; and / or to fix the corresponding helical turns to tissue using the anchor - by driving the tissue engaging element of the anchor through the wall and into the tissue from the cavity such that the helical turns are sandwiched between the head and the tissue.

[0138] In some applications, the tissue engaging element of each anchor is configured to pierce the helical member, and the at least one anchor driver is configured for each anchor to fix the corresponding helical turns to tissue using the anchor - by driving the tissue engaging element of the anchor through the helical member at the helical turns and into the tissue such that the helical turns are sandwiched between the head and the tissue.

[0139] In some applications, the at least one anchor driver is configured such that for each anchor, the corresponding coil turn is fixed to tissue using the anchor - by driving the tissue - engaging element of the anchor through a wall adjacent the coil turn from a lumen and into the tissue, such that the coil turn is clamped between the head and the tissue.

[0140] In some applications, the at least one anchor driver is configured to advance each anchor body into and along a lumen.

[0141] In some applications, the sleeve is elastic.

[0142] In some applications, each anchor is sized to be advanceable through the lumen when the tissue - engaging element of the anchor is disposed distally of the head of the anchor.

[0143] In some applications, the helical member comprises fabric. In some applications, the helical member comprises a polymer. In some applications, the helical member is metallic. In some applications, the helical member comprises a shape - memory material.

[0144] In some applications, the system and / or device further comprises an elongate constricting member extending along and coupled to the body portion, the constricting member being configured to constrict the body portion when tensioned.

[0145] In some applications, the constricting member extends radially inwardly from the helical member through the lumen.

[0146] In some applications, the system and / or device further comprises an actuable adjustment mechanism configured to constrict the body portion by tensioning the constricting member upon actuation. In some embodiments, the actuable adjustment mechanism is coupled to the body portion and to the constricting member.

[0147] In some applications, the system and / or device further comprises a tool having an anchor channel extending into the lumen, and the anchor driver is configured to advance the anchor along the lumen by advancing the anchor through the anchor channel.

[0148] In some applications, the anchor channel has a distal opening, and the anchor driver is configured to eject the anchor from the distal opening of the anchor channel and through a portion of the wall directly in front of the distal opening.

[0149] In some applications, the tool is configured to deliver an annuloplasty structure through the lumen to the heart when the anchor channel is disposed within the lumen.

[0150] In some applications, the tool is configured to progressively advance the body portion out of the anchor channel.

[0151] In some applications, the tool includes a protrusion that extends radially outward from the anchor channel and engages the helical member to inhibit slippage of the body portion from the channel.

[0152] In some applications, the tool is configured to facilitate control of the advancement of the body portion out of the anchor channel via rotation of the protrusion about the central longitudinal axis of the anchor channel.

[0153] In some applications, the protrusion is rigidly fixed to the anchor channel. In some applications, the protrusion is movable relative to the anchor channel. In some applications, the protrusion is longitudinally slidable relative to the anchor channel.

[0154] According to some applications, a method is further provided that includes advancing an elongated annuloplasty structure through a lumen into an object. The annuloplasty structure includes a body portion (e.g., a flexible body portion) having a wall (e.g., a tubular wall, etc.). The wall can be a tubular wall that defines a lumen along the body portion.

[0155] In some embodiments, the wall includes a sleeve and a helical member that is stiffer than the sleeve and is coupled to the sleeve. The helical member can be configured to define a plurality of turns that extend in a helical path along and around the lumen; and

[0156] The method includes securing the body portion to the tissue of the object. This can be accomplished by advancing a plurality of anchors through the lumen using at least one anchor driver, each anchor including a head and a tissue engaging element; and for each anchor, securing the corresponding turn to the tissue - by driving the tissue engaging element of the anchor through the wall and into the tissue from the lumen such that the turn is sandwiched between the head and the tissue. This method can be performed on a living animal or a non-living cadaver, cadaver heart, simulator (e.g., where the tissue is simulated tissue, etc.), anthropomorphic phantom, etc.

[0157] In some applications, securing the corresponding turn using the anchor driver includes securing the corresponding turn to the tissue using the anchor driver by driving the tissue engaging element of the anchor through the helical member at the turn and into the tissue such that the turn is sandwiched between the head and the tissue.

[0158] In some applications, securing the corresponding turn using the anchor driver includes securing the corresponding turn to the tissue using the anchor driver by driving the tissue engaging element of the anchor through the wall adjacent to the turn and into the tissue such that the turn is sandwiched between the head and the tissue.

[0159] In some applications, the method further includes advancing each anchor into the lumen within the body.

[0160] In some applications, advancing the plurality of anchors along a lumen using an anchor driver includes: advancing the plurality of anchors along the lumen using the anchor driver when the tissue engaging element of the anchor is disposed distally of the head of the anchor.

[0161] In some applications, the annuloplasty structure further includes an elongate constricting member extending along and coupled to the body portion, and the method further includes constricting the body portion by tensioning the constricting member.

[0162] In some applications, the constricting member extends radially inwardly from a helical member through a lumen, and constricting the body portion by tensioning the constricting member includes: constricting the body portion by tensioning the constricting member that extends radially inwardly from the helical member through the lumen.

[0163] The various systems and / or devices described herein and elsewhere herein may further include an adjustment mechanism (e.g., on the annuloplasty structure, on a catheter, on other devices, etc.), and constricting the body portion by tensioning the constricting member includes: constricting the body portion by actuating the adjustment mechanism to tension the constricting member. In some embodiments, the adjustment mechanism is coupled to the body portion of the annuloplasty structure and / or coupled to the constricting member. Additionally, the methods herein may include constricting the body portion by tensioning the constricting member, including for example by actuating the adjustment mechanism to tension the constricting member, to constrict the body portion.

[0164] In some applications, advancing the plurality of anchors along a lumen using an anchor driver includes: advancing the plurality of anchors through an anchor channel disposed within the lumen using the anchor driver. In some applications, securing a corresponding coil turn to tissue using an anchor driver includes: securing a corresponding coil turn to tissue using the anchor driver by pushing the anchor out of the distal opening of the anchor channel and through a portion of the wall directly in front of the distal opening.

[0165] In some applications, advancing an annuloplasty structure through a lumen includes: delivering the annuloplasty structure through the lumen to a subject when the anchor channel is disposed within the lumen.

[0166] In some applications, the method further includes, after securing each coil turn to tissue, advancing a portion of the body portion out of the anchor channel.

[0167] In some applications, the anchor channel has a protrusion coupled thereto that extends radially outwardly from the anchor channel, and the method further includes controlling the advancement of the body portion out of the anchor channel by rotating the protrusion about a central longitudinal axis of the anchor channel.

[0168] In some applications, rotating the projection about the central longitudinal axis of the anchor channel includes rotating the anchor channel about the central longitudinal axis of the anchor channel.

[0169] In some applications, controlling the advancement of the body portion out of the anchor channel further includes longitudinally sliding the projection relative to the anchor channel.

[0170] Other features and steps described elsewhere herein may also be used in conjunction with the systems, devices, apparatuses, methods, etc. described above. A more complete understanding can be obtained from the following detailed description of the embodiments in conjunction with the accompanying drawings, in which: BRIEF DESCRIPTION OF THE DRAWINGS

[0171] Figures 1-5 and Figure 6A -D is a schematic view of a corresponding example annuloplasty structure including a controllable expansion section;

[0172] Figure 7 is a schematic view of an example annuloplasty structure according to some applications, which can be shortened after the annuloplasty structure is anchored to the annulus tissue.

[0173] Figure 8A -B is a schematic view of an example annuloplasty structure including a deformable section;

[0174] Figures 9-12 is a schematic view of a corresponding example annuloplasty structure including a corresponding fabric composition;

[0175] Figure 13A -C is a schematic view of an example system for compressing a portion of an annuloplasty structure;

[0176] Figures 14-15 is a corresponding flowchart of at least some example steps in the corresponding technology described herein Figures 1-13C described;

[0177] Figure 16 is a schematic view of an example annuloplasty structure including different fabric compositions.

[0178] Figure 17A -F is a schematic view of an example annuloplasty structure including a removable connection;

[0179] Figure 18A -C is a schematic view of an example system including a variable stretch annuloplasty ring structure;

[0180] Figure 19 is a schematic view of an example system including a telescopically expandable annuloplasty structure; and

[0181] Figure 20 , 21A-B, 22A-C, and 23 are schematic views of an example annuloplasty system including an example elongate annuloplasty structure DETAILED DESCRIPTION

[0182] The following description and drawings that describe and show certain embodiments illustrate, in a non-limiting manner, several possible configurations of systems, devices, apparatuses, methods, etc. that may be used in various aspects and features of the present disclosure. As an example, various systems, devices / apparatuses, and methods are described herein, including systems, platforms, devices, methods, etc. related to adjustable annuloplasty devices.

[0183] Figure 1 is a schematic view of a system 20 according to some applications, the system 20 including an implant that includes an annuloplasty structure 22 (e.g., an annuloplasty ring structure, an annuloplasty band, a partial annuloplasty ring, a complete annuloplasty ring, etc.), the annuloplasty structure 22 including a body portion 23 (e.g., an annuloplasty ring body portion), the body portion 23 being manufactured such that it is shaped and configured to define one or more controllable expansion sections 40. The annuloplasty structure 22 includes a flexible sleeve 26 that is shaped and configured to define a lumen therethrough. The controllable expansion sections 40 enable the annuloplasty structure 22 to be delivered to the annulus of a patient's heart valve (e.g., typically, but not necessarily, the mitral or tricuspid valve) in a shortened state. The controllable expansion sections 40 enable the annuloplasty structure 22 to be controllably expanded after being within the patient's body.

[0184] Each controllable expansion section 40 may include a corresponding portion of the flexible material of the sleeve 26. During the manufacturing process of the sleeve 26, the sections 40 that define this portion of the sleeve 26 may be folded or invaginated. Each of these portions may be telescopically folded in a direction A away from the longitudinal axis 21 of the annuloplasty structure 22. This direction may be perpendicular to the axis 21. As Figure 1 shown, this telescopic folding enables compression of a portion of the sleeve 26 without affecting the overall inner diameter of the sleeve 26. Additionally, this telescopic folding enables subsequent expansion of the sections 40 along the longitudinal axis 21.

[0185] When in the compressed state, each controllable expansion section 40 may define a longitudinal length L1 of 6 - 10 mm, e.g., 8 mm, measured along the longitudinal axis 21 of the structure 22. When in the expanded state, each controllable expansion section 40 may define a longitudinal length L2 of 12 - 18 mm, e.g., 16 mm, measured along the longitudinal axis 21 of the structure 22. The longitudinal length L2 is greater than the longitudinal length L1.

[0186] Each section 40 can be folded to form a pocket 43 between the layers of the fold of section 40. The pocket 43 can have a longitudinal length L13 of 6.5 - 9.5 mm, such as 7.5 mm, which is measured along the pocket axis that is generally parallel to the longitudinal axis of the annuloplasty ring body portion at that part of the annuloplasty ring body portion including section 40.

[0187] Each fold of section 40 can optionally be held together by a knot 44, such as a skip knot or any other easily separable tie. For some applications, the sleeve 26 is manufactured such that the sections 40 are biased so that each section 40 expands passively after the knot 44 is removed. For some applications, as shown below, the sections 40 can be pulled apart by corresponding control filaments.

[0188] For some applications, after the structure 22 is positioned against the heart tissue, the sleeve 26 is expanded.

[0189] As Figure 1 shown in the lower figure therein, after a given controllable expansion section 40 is expanded, a tissue anchor 32 or other attachment device can be used to anchor or attach the section 42 of the sleeve 26 adjacent to the currently expanded controllable expansion section 40 to the heart tissue. Although the tissue anchor 32 is depicted in various embodiments and figures herein as a helical anchor that can be rotated or screwed into the tissue, other types of tissue anchors or other attachment devices (e.g., flexible anchors, rigid anchors, staples, fasteners, clamps, adhesives, sutures, etc.) can also be used. This sequential anchoring of the sleeve 26 to the tissue immediately after the first controllable expansion section 40 is expanded but before the second controllable expansion section 40 is expanded enables the operator to alternate between expansion and anchoring and enables the operator to control the overall amount of expansion of the sleeve 26. After a sufficient amount of the sleeve 26 is anchored to the annulus tissue 10, the physician can choose to keep the remaining controllable expansion sections 40 in their compressed state. In this way, the system 20 minimizes the likelihood of any excess sleeve 26 interfering with the heart valve. Additionally, with the system 20, the physician does not need to measure the size of the annulus before positioning the annuloplasty ring structure 22. In this way, the structure 22 adapts to and fits all natural annulus sizes.

[0190] For some applications, the sections 42 are marked with radiopaque markers. For some applications, the sections 42 are designated as anchor - designated sections. In an exemplary application, the structure 22 includes a plurality of controllable expansion sections 40 that are alternately arranged with a plurality of anchor - designated sections 42.

[0191] The sleeve 26 may include a braided fabric mesh, e.g., which includes polyethylene terephthalate, Dacron(TM), other materials, etc. The body portion 23 (e.g., the sleeve 26) may be configured to be arranged only partially around the cardiac annulus (i.e., in a C-shape), and after being anchored in place, to be contracted to circumferentially tighten the annulus. Optionally, the body portion may be configured to completely surround the annulus. To tighten the annulus, the system 20 may include an actuatable adjustment mechanism or a contraction mechanism. The adjustment mechanism or contraction mechanism may be part of one or more of the annuloplasty structure 22, the flexible elongate contraction member 30 extending along the sleeve 26, and / or other components of the system (e.g., a catheter, etc.), and / or coupled to one or more of the annuloplasty structure 22, the flexible elongate contraction member 30 extending along the sleeve 26, and / or other components of the system (e.g., a catheter, etc.). The elongate contraction member 30 may include a wire, a ribbon, a cord, or a band, which may include a flexible and / or superelastic material, e.g., nitinol, polyester, stainless steel, or cobalt chrome. For some applications, the contraction member 30 includes a radiopaque material. For some applications, the contraction member 30 includes a braided polyester suture (e.g., Ticron). For some applications, the contraction member 30 is coated, e.g., coated with polytetrafluoroethylene (PTFE) or other polymers. For some applications, the contraction member 30 includes multiple wires intertwined to form a cord structure.

[0192] The actuatable adjustment mechanism or contraction mechanism may be configured in a variety of ways. For some applications, e.g., the actuatable adjustment mechanism includes a spool or a rotating member around which the contraction member may be collected. For some applications, the actuatable adjustment mechanism includes a tensioner that applies tension to the contraction member. For some applications, the actuatable adjustment mechanism includes a gripper that grips the contraction member in a manner that allows the user to apply tension to the contraction member. For some applications, the actuatable adjustment mechanism includes one catheter or multiple catheters that are configured to interact to pull the contraction member proximally and / or to tension it to cause the annuloplasty structure to contract (e.g., one catheter grips the contraction member and allows it to be pulled, while the other catheter provides resistance to the annuloplasty structure, etc.). Other applications are possible.

[0193] After the physician has positioned the structure 22 along the annulus and has expanded any number of the controllable expansion segments 40, the annuloplasty structure 22 is contracted using the contraction member 30. For some applications, the contraction member 30 is coupled to an actuatable contraction mechanism as described in U.S. Patent Application Publication 2014 / 0309661 to Sheps et al. and / or U.S. Patent Application Publication 2015 / 0272734 to Sheps et al., which are incorporated herein by reference. Additionally, the implantation of the structure 22 may be accomplished using any of the methods described in the '661 and / or '734 applications.

[0194] Figures 2-3 is a schematic diagram of a system 120 for some applications. The system 120 includes an implant, which includes a structure 122 (e.g., an annuloplasty structure, an annuloplasty ring structure, etc.). The structure 122 includes a body portion 123 (e.g., an annuloplasty body portion, an annuloplasty ring body portion, etc.). The body portion 123 is shaped and configured to define one or more controllable expansion sections 40. Except as described below, the structure 122 is generally similar to the structure 22 referred to above Figure 1 and the same reference numerals refer to the same parts.

[0195] The structure 122 may include a single control wire 50 that is connected to all the knots 44 and thus to all the controllable expansion sections 40 (although multiple control wires may be used in some embodiments). In an exemplary embodiment, as shown, after the control wire 50 is pulled, the wire 50 releases all the knots 44. After all the knots 44 are released, the sleeve 26 can expand fully and be anchored to the tissue. As Figure 2 shown, after all the controllable expansion sections 40 have expanded, the sleeve 26 is anchored to the heart tissue using the anchor 32. That is, the structure 122 is only anchored to the annulus tissue 10 after the sleeve 26 has expanded.

[0196] As Figure 3 shown, the control wire 50 can be pulled progressively and gradually, and the corresponding anchor 32 or other attachment means can be used to anchor or attach the sleeve 26 to the heart tissue. This sequential anchoring of the sleeve 26 to the tissue immediately after the first controllable expansion section 40 expands but before the second controllable expansion section 40 expands enables the operator to alternate between expansion and anchoring and also enables the operator to control the overall expansion amount of the sleeve 26. After a sufficient amount of the sleeve 26 is anchored to the annulus tissue 10, the physician can choose to keep the remaining controllable expansion sections 40 in their compressed state. In this way, the system 120 minimizes the likelihood of any excess sleeve 26 interfering with the heart valve. Additionally, using the system 120, the physician does not need to measure the size of the annulus before positioning the annuloplasty ring structure 122. In this way, the structure 122 adapts to and fits all natural annulus sizes.

[0197] After the physician has positioned structure 122 along the annulus and has expanded any number of the controllable expansion segments 40, the structure 122 is contracted using the contraction member 30. For some applications, the contraction member 30 is coupled to an actuatable contraction mechanism or adjustment mechanism, and / or is part of an actuatable contraction mechanism or adjustment mechanism, e.g., as described elsewhere herein and / or as described in U.S. Patent Application Publication 2014 / 0309661 to Sheps et al. and / or U.S. Patent Application Publication 2015 / 0272734 to Sheps et al. (which are incorporated herein by reference). Additionally, any method described in the '661 and / or '734 applications can be used to effect implantation of the structure 122.

[0198] Figure 4 is a schematic illustration of a system 220 according to some applications, the system 220 including an implant that includes a structure 222 (e.g., an annuloplasty structure, an annuloplasty ring structure, etc.), the structure 222 including a body portion 223 (e.g., an annuloplasty body portion, an annuloplasty ring body portion, etc.), the body portion 223 being shaped and configured to define one or more controllable expansion segments 40. Except as described below, the structure 222 is generally similar to the structure 22 described above with reference to Figure 1 and like reference numerals refer to like parts.

[0199] The structure 222 can include a plurality of control filaments, such as filaments 50a, 50b, and 50c. That is, the structure 222 can include a control filament 50 corresponding to each controllable expansion segment 40. Each of the control filaments 50a, 50b, and 50c can be coupled to a knot 44 of a corresponding controllable expansion segment 40. After each corresponding control filament 50 is pulled, as shown, the filament 50 releases all of the knots 44 of the corresponding controllable expansion segment.

[0200] In an exemplary application, after the control filament 50a has been pulled and the segment 40 has been expanded, a tissue anchor 32 or other attachment device can be used to anchor or attach the sleeve 26 to the heart tissue at the segment 42. This sequential anchoring of the sleeve 26 to the tissue immediately following expansion of the first controllable expansion segment 40 but prior to expansion of the second controllable expansion segment 40 by the control filament 50b enables the operating physician to alternate between expansion and anchoring and enables the operating physician to control the overall amount of expansion of the sleeve 26. After a sufficient amount of the sleeve 26 has been anchored to the annulus tissue 10, the physician can elect to keep the remaining controllable expansion segments 40 in their compressed state. In this way, the system 20 minimizes the likelihood of any excess sleeve 26 interfering with the heart valve. Additionally, with the system 20, the physician does not need to measure the size of the annulus prior to positioning the annuloplasty ring structure 22. In this way, the structure 22 accommodates and adapts to all natural annulus sizes.

[0201] After the physician has positioned the structure 222 along the annulus and expanded any number of the controllable expansion segments 40, the annulus shaping structure 222 is contracted using the contraction member 30 without relying on any of the remaining control filaments 50 coupled to the body portion of the structure 222. For some applications, the contraction member 30 is coupled to an actuatable contraction mechanism or adjustment mechanism, and / or is part of an actuatable contraction mechanism or adjustment mechanism, such as, for example, as described elsewhere herein and / or as described in U.S. Patent Application Publication 2014 / 0309661 to Sheps et al. and / or U.S. Patent Application Publication 2015 / 0272734 to Sheps et al., which are incorporated herein by reference. Additionally, any method described in the '661 and / or '734 applications can be used to accomplish the implantation of the structure 222.

[0202] Figure 5 is a schematic diagram of a system 250 according to some applications, the system 250 including an implant that includes a structure 252 (e.g., an annulus shaping structure, an annulus shaping ring structure, etc.), the structure 252 including a body portion (e.g., an annulus shaping body portion, an annulus shaping ring body portion, etc.) that is shaped and configured to define one or more controllable expansion segments 40. Except as described below, the structure 252 is generally similar to the structure 22 referenced above Figure 1 and the same reference numerals refer to the same parts.

[0203] The structure 252 includes one or more control filaments 50. For some applications, the structure 252 includes a control filament 50 corresponding to each controllable expansion segment 40. Corresponding portions of the control filaments 50 are reversibly and directly coupled to the controllable expansion segments 40 of the material of the sleeve 26 at the coupling points 254. After pulling the control filaments 50, as shown, the filaments 50 actively pull the material of the sleeve 26 to facilitate the expansion of the controllable expansion segments 40.

[0204] As shown in the exemplary application, after the control filaments 50 have been pulled and the segment 40 has expanded, a tissue anchor 32 or other attachment device can be used to anchor or attach the sleeve 26 to the heart tissue at the segment 42. This sequential anchoring of the sleeve 26 to the tissue immediately following the expansion of the first controllable expansion segment 40 but prior to the expansion of the second controllable expansion segment 40 by the control filaments 50 enables the operating physician to alternate between expansion and anchoring and enables the operating physician to control the overall amount of expansion of the sleeve 26. After a sufficient amount of the sleeve 26 has been anchored to the annulus, the physician can choose to keep the remaining controllable expansion segments 40 in their compressed state. In this way, the system 250 minimizes the likelihood of any excess sleeve 26 interfering with the heart valve. Additionally, with the system 250, the physician does not need to measure the size of the annulus prior to positioning the annulus shaping ring structure 252. In this way, the structure 252 accommodates and adapts to all natural annulus sizes.

[0205] After the physician has positioned the structure 252 along the annulus and any number of the controllable expansion segments 40 have been expanded, the annuloplasty structure 252 is contracted using the contraction member 30 independent of any remaining control wires 50 coupled to the body portion of the structure 252. For some applications, the contraction member 30 is coupled to an actuatable contraction mechanism or adjustment mechanism, and / or is part of an actuatable contraction mechanism or adjustment mechanism, such as, for example, as described elsewhere herein and / or as described in U.S. Patent Application Publication 2014 / 0309661 to Sheps et al. and / or U.S. Patent Application Publication 2015 / 0272734 to Sheps et al., which are incorporated herein by reference. Additionally, any method described in the '661 and / or '734 applications may be used to accomplish the implantation of the structure 252.

[0206] Figure 6A -D is a schematic illustration of a system 420 according to some applications, the system 420 including an implant that includes a structure 422 (e.g., an annuloplasty structure, an annuloplasty ring structure, etc.), the structure 422 including a body portion (e.g., an annuloplasty body portion, an annuloplasty ring body portion, etc.) that is shaped and configured to define one or more controllable expansion segments 40. The structure 422 includes a sleeve 426 and a contraction member 30. Except as described below, the structure 422 is generally similar to the structure 22 described above with reference to Figure 1 and like reference numerals refer to like parts.

[0207] The sleeve 426 can be manufactured such that the segments 40 are biased such that each segment 40 maintains its folded shape. For example, during the manufacturing process, each segment 40 can be ironed or otherwise set to present a folded shape. For some applications, as shown below, each segment 40 can be pulled apart by its corresponding control wire to which it is coupled. For some applications, each segment 40 can be pulled apart by pulling on different segments of the sleeve 426, such as the ends. As Figure 6A shown, the structure 422 is delivered to the annulus in a shortened state where the controllable expansion segments 40 present their corresponding folded states and each segment 40 presents a length L1.

[0208] In Figure 6B after positioning the structure 422 along the annulus tissue 10, the physician pulls apart a first segment 40a and then drives an anchor 32 into the annulus tissue 10 at an anchor-designated segment 42a to hold the current open and unfolded state of the segment 40a such that the segment 40a currently presents a length L2, the length L2 being greater than the length L1.

[0209] For some applications, the various parts 42 are marked with radiopaque markers. For some applications, the various parts 42 are designated as anchor-designated segments.

[0210] In Figure 6C this, the physician pulls apart the second section 40b and then drives the anchor 32 into the annulus tissue 10 at the anchor - specified section 42b to maintain the current open and unfolded state of the section 40b such that the section 40b currently presents a length L2, where the length L2 is greater than the length L1.

[0211] In Figure 6D this, the physician determines that the total length of the structure 422 anchored to the annulus tissue 10 is sufficient and thus the structure 422 does not require any further expansion. To prevent unintentional further expansion of the sections 40c and 40d, the physician drives the corresponding tissue anchors 32 through each of the sections 40c and 40d to maintain the sections 40c and 40d in their compressed state. Subsequently, the structure 422 is contracted using the contraction member 30 to reshape the annulus.

[0212] This sequential anchoring of the sleeve 426 to the tissue immediately following the expansion of the first controllable expansion section 40a but prior to the expansion of the second controllable expansion section 40b enables the operating physician to alternate between expansion and anchoring and enables the operating physician to control the overall amount of expansion of the sleeve 426. After a sufficient amount of the sleeve 426 has been anchored to the annulus, the physician can choose to keep the remaining controllable expansion sections 40c and 40d in their compressed state. In this way, the system 420 minimizes the likelihood of any excess sleeve 426 interfering with the heart valve. Additionally, with the system 420, the physician does not need to measure the size of the annulus prior to positioning the annuloplasty ring structure 422. In this way, the structure 422 adapts to and fits all natural annulus sizes.

[0213] The sleeve 426 may include a woven fabric mesh, for example, including polyethylene terephthalate, Dacron(TM), other materials, etc. The body portion 23 (e.g., the sleeve 426) may be configured to be disposed only partially around the cardiac valve annulus (i.e., in a C-shape), and after being anchored in place, is contracted to circumferentially tighten the annulus. Optionally, the body portion may be configured to be disposed completely around the annulus. To tighten the annulus, the system 420 includes an actuatable adjustment mechanism or contraction mechanism. The adjustment mechanism or contraction mechanism may be part of one or more of the annuloplasty structure 422, the flexible elongate contraction member 30 extending along the sleeve 426, and / or other components of the system, and / or coupled to one or more of the annuloplasty structure 422, the flexible elongate contraction member 30 extending along the sleeve 426, and / or other components of the system. The elongate contraction member 30 may include a wire, strip, cord, or strap, which may include a flexible and / or superelastic material, such as nitinol, polyester, stainless steel, or cobalt chrome. For some applications, the contraction member 30 includes a radiopaque material. For some applications, the contraction member 30 includes a braided polyester suture (e.g., Ticron). For some applications, the contraction member 30 is coated with polytetrafluoroethylene (PTFE). For some applications, the contraction member 30 includes multiple wires intertwined to form a cord structure. The actuatable adjustment mechanism or contraction mechanism may be configured in various ways, as described in other parts of this document regarding other actuatable adjustment mechanisms and / or in any way described in other documents incorporated by reference.

[0214] After the physician has positioned the structure 422 along the annulus and has expanded any number of the controllable expansion segments 40, the annuloplasty structure 422 is contracted using the contraction member 30. For some applications, the contraction member 30 is coupled to an actuatable contraction mechanism or adjustment mechanism, and / or is part of an actuatable contraction mechanism or adjustment mechanism, for example, as described in other parts of this document and / or as described in U.S. Patent Application Publication 2014 / 0309661 to Sheps et al. and / or U.S. Patent Application Publication 2015 / 0272734 to Sheps et al. (which are incorporated by reference herein). Additionally, any method described in the '661 and / or '734 applications may be used to complete the implantation of the structure 422.

[0215] Figure 7FIG. 0 is a schematic illustration of a system 320 for some applications, the system 320 including a structure 322 (e.g., an annuloplasty structure, an annuloplasty ring structure, etc.), the structure 322 having a flexible body portion 332 (e.g., an annuloplasty body portion, an annuloplasty ring body portion, etc.), the body portion 332 including a tapered sleeve 326 and a constriction member 30. The sleeve 326 is shaped and configured to define a lumen therethrough. The sleeve 326 is shaped and configured to define a first end 321 and a second end 323, the first end 321 having a first maximum cross-sectional measurement M1 of 4-6 mm (e.g., 5 mm), the second end 323 having a second maximum cross-sectional measurement M2 of 3.0-3.9 mm (e.g., 3.5 mm), the second maximum cross-sectional measurement being less than the first maximum cross-sectional measurement.

[0216] Any number of tissue anchors 32 or other attachment devices can be used to anchor or attach the structure 322 to the annulus of a valve. After a sufficient amount of the sleeve 326 has been anchored to the annulus, the physician uses a push tool 340 to fold or push the excess portion 330 of the sleeve 326 into the lumen of the portion of the sleeve 326 that has been anchored to the annulus. That is, the physician folds the second end portion of the sleeve 326 toward the first end portion of the sleeve 326. In this manner, the system 320 minimizes the likelihood of any excess sleeve 326 interfering with the heart valve. Additionally, with the system 320, the physician does not need to measure the size of the annulus before positioning the annuloplasty ring structure 322. In this manner, the structure 322 accommodates and adapts to all natural annulus sizes.

[0217] For some applications, a cutting tool (not shown) can be used to cut the excess portion 330 of the sleeve 326.

[0218] The sleeve 326 may include a woven fabric mesh, for example, including polyethylene terephthalate, Dacron(TM), other materials, etc. The body portion 332 (e.g., the sleeve 326) may be configured to be disposed only partially around the cardiac annulus (i.e., in a C-shape), and after being anchored in place, be contracted to circumferentially tighten the annulus. Optionally, the body portion may be configured to be disposed completely around the annulus. To tighten the annulus, the system 320 includes an actuatable adjustment mechanism or contraction mechanism. The adjustment mechanism or contraction mechanism may be part of one or more of the annuloplasty structure 322, the flexible elongate contraction member 30 extending along the sleeve 326, and / or other components of the system (e.g., a catheter, etc.), and / or be coupled to one or more of the annuloplasty structure 322, the flexible elongate contraction member 30 extending along the sleeve 326, and / or other components of the system (e.g., a catheter, etc.). The elongate contraction member 30 may include a wire, a strip, a cord, or a tape, which may include a flexible and / or superelastic material, such as nitinol, polyester, stainless steel, or cobalt chromium. For some applications, the contraction member 30 includes a radiopaque material. For some applications, the contraction member 30 includes a woven polyester suture (e.g., Ticron). For some applications, the contraction member 30 is coated with polytetrafluoroethylene (PTFE). For some applications, the contraction member 30 includes multiple wires intertwined to form a cord structure. The actuatable adjustment mechanism or contraction mechanism may be configured in various ways, as described in other parts of this document regarding other actuatable adjustment mechanisms and / or in any way described in other documents incorporated by reference.

[0219] After the physician has positioned the structure 322 along the annulus and has pushed the excess portion 330 into the lumen of the portion of the sleeve 326 that has been anchored to the cardiac tissue, the annuloplasty structure 322 is contracted using the contraction member 30. For some applications, the contraction member 30 is coupled to an actuatable contraction mechanism or adjustment mechanism, and / or is part of an actuatable contraction mechanism or adjustment mechanism, for example, as described in other parts of this document and / or as described in U.S. Patent Application Publication 2014 / 0309661 to Sheps et al. and / or U.S. Patent Application Publication 2015 / 0272734 to Sheps et al. (which are incorporated herein by reference). Additionally, any method described in the '661 and / or '734 applications may be used to complete the implantation of the structure 322.

[0220] In this manner, the system 320 facilitates delivery of an elongate structure or annuloplasty ring structure (e.g., structure 322, as shown) to the annulus in an elongate state, partial anchoring to the annulus, and then, after anchoring, shortening of the elongate structure while maintaining the integrity of the body portion of the structure or annuloplasty ring structure (e.g., by not cutting or severing any portion of the body portion), and, after shortening, contracting the structure or annuloplasty ring structure by the contraction member 30 to contract and reshape the patient's annulus. In this way, pre-shortening of the structure or annuloplasty ring structure reduces the total contraction force required to contract the structure or annuloplasty ring structure.

[0221] Accordingly, the system 320 provides a method for (a) delivering the structure 322 to the annulus of a patient with the body portion 332 having a first longitudinal length L3 of 120 - 136 mm, (b) after delivery, shortening the body portion 332 to a second longitudinal length L4 of 40 - 68 mm without relying on the contraction member 30 while maintaining the overall integrity of the annuloplasty body portion 332 (e.g., not cutting or severing any portion of the portion 332), and (c) after shortening, reshaping the annulus by contracting the body portion 332 by utilizing the contraction member 30. This means that the body portion 332 will only need to contract along a smaller length (i.e., length L4), rather than along a larger length L3 (i.e., if the excess portion 330 is not pushed into the lumen of the sleeve 326). Thereby, pushing the excess portion 330 into the lumen of the sleeve 326 reduces the total force required to contract the body portion 332 after anchoring to the annulus.

[0222] Figure 8A-B is a schematic illustration of a system 520 for some applications. The system 520 includes a structure 522 (e.g., an annuloplasty structure, an annuloplasty ring structure, etc.). The structure 522 has a flexible body portion 523 (e.g., an annuloplasty body portion, an annuloplasty ring body portion, etc.). The body portion 523 includes (a) a sleeve 526 having an anchor coupling region or attachment region 531 and a deformable region 530, and (b) a shrinkage member 30. The sleeve 526 is shaped and configured to define a lumen therethrough. The body portion 523 is shaped and configured to define a first body portion end 521 and a second body portion end 525. The anchor coupling region or attachment region 531 is disposed between the first body portion end 521 and a location near the body portion 523 between the first body portion end 521 and the second body portion end 525 (excluding the second body portion end 525). The deformable region 530 is disposed between the second body portion end 525 and a location near the body portion 523 between the first body portion end 521 and the second body portion end 525 (excluding the first body portion end 521). Additionally, the body portion 523 may include a plurality of radiopaque markers 560 that indicate to a physician where to implant the anchors 32.

[0223] Optionally, the deformable region 530 may include a superelastic material, such as nitinol, which enables the deformable region 530 to assume its shape. For some applications, the superelastic material has shape memory.

[0224] Using an anchor delivery system or attachment system 550, any number of tissue anchors 32 or other attachment devices can be used to anchor or attach the structure 522 to the annulus of a valve. In an exemplary application, the anchor delivery system 550 includes a tube. When the tube of the system 550 is at least disposed within the lumen of the deformable region 530, the deformable region 530 assumes a first generally linear shape, as Figure 8A shown. After a sufficient amount of the sleeve 526 is anchored to the annulus, the physician removes the system 550 from the lumen of the sleeve 526, and the deformable region 530 passively assumes a second deformed shape. As shown, by way of example and not limitation, the second deformed shape is helical. Thus, with the system 520, the physician does not need to measure the size of the annulus before positioning the annuloplasty ring structure 522. In this manner, the structure 522 adapts to and fits all natural annulus sizes.

[0225] The sleeve 526 may include a braided fabric mesh, e.g., including polyethylene terephthalate, Dacron(TM), other materials, etc. The body portion 523 (e.g., the sleeve 526) may be configured to be disposed only partially around the cardiac valve annulus (i.e., in a C-shape), and after being anchored in place, be contracted to circumferentially tighten the annulus. Optionally, the body portion may be configured to be disposed completely around the annulus. To tighten the annulus, the system 520 includes an actuatable adjustment mechanism or contraction mechanism. The adjustment mechanism or contraction mechanism may be part of one or more of the annuloplasty structure 522, the flexible elongate contraction member 30 extending along the sleeve 526, and / or other components of the system (e.g., a catheter, etc.), and / or be coupled to one or more of the annuloplasty structure 522, the flexible elongate contraction member 30 extending along the sleeve 526, and / or other components of the system (e.g., a catheter, etc.). The elongate contraction member 30 may include a wire, strip, cord, or strap, which may include a flexible and / or superelastic material, e.g., nitinol, polyester, stainless steel, or cobalt chrome. For some applications, the contraction member 30 includes a radiopaque material. For some applications, the contraction member 30 includes a braided polyester suture (e.g., Ticron). For some applications, the contraction member 30 is coated with polytetrafluoroethylene (PTFE). For some applications, the contraction member 30 includes multiple wires intertwined to form a cord structure. The actuatable adjustment mechanism or contraction mechanism may be configured in various ways, as described in other parts of this document regarding other actuatable adjustment mechanisms and / or in any way described in other documents incorporated by reference.

[0226] After the physician has positioned the structure 522 along the annulus and has caused the deformable region 530 to assume a deformed shape, the annuloplasty structure 522 is contracted using the contraction member 30. For some applications, the contraction member 30 is coupled to an actuatable contraction mechanism or adjustment mechanism, and / or is part of an actuatable contraction mechanism or adjustment mechanism, e.g., as described in other parts of this document and / or as described in U.S. Patent Application Publication 2014 / 0309661 to Sheps et al. and / or U.S. Patent Application Publication 2015 / 0272734 to Sheps et al. (which are incorporated by reference herein). Additionally, any of the methods described in the '661 and / or '734 applications may be used to accomplish the implantation of the structure 522.

[0227] In this manner, the system 520 facilitates delivery of an elongate structure or annuloplasty ring structure (e.g., structure 522, as shown) to the annulus in an elongate state, partial anchoring to the annulus, and then, after anchoring, shortening of the elongate structure while maintaining the integrity of the body portion of the structure or annuloplasty ring structure (e.g., by not cutting or severing any portion of the body portion), and after shortening, contracting the structure or annuloplasty ring structure by the contraction member 30 to contract and reshape the patient's annulus. In this manner, pre-shortening of the structure or annuloplasty ring structure reduces the total contraction force required to contract the structure or annuloplasty ring structure.

[0228] Accordingly, the system 520 provides a method for (a) delivering structure 522 to the annulus of a patient with a first longitudinal length L5 of the body portion 523 being 122 - 130 mm (e.g., 125 mm), (b) after delivery, shortening the body portion 523 to a second longitudinal length L6 of 90 - 129 mm (e.g., 100 mm) without relying on the contraction member 30 while maintaining the overall integrity (e.g., not cutting or severing) of the body portion or annuloplasty body portion 523, and (c) after shortening, reshaping the annulus by contracting the body portion 523 by utilizing the contraction member 30. This means that the body portion 523 will only need to contract along a smaller length (i.e., length L6) rather than along a larger length L5 (i.e., if the deformable region is not deformed). Thus, deforming the region 530 reduces the total force required to contract the body portion 523 after anchoring to the annulus.

[0229] Now referring Figure 9 , Figure 9 is a schematic view of a system 620 according to some applications. The system 620 includes a structure 622 (e.g., an annuloplasty structure, an annuloplasty ring structure, etc.). The structure 622 has a flexible body portion 623 (e.g., an annuloplasty body portion, an annuloplasty ring body portion, etc.). The body portion 623 includes a sleeve 626 and a contraction member 30. The body portion 623 includes a sleeve 626. The body portion 623 includes a flexible material that includes a plurality of intertwined fibers.

[0230] A first portion 650 of the plurality of intertwined fibers is oriented at an angle α of 20 - 70 degrees (e.g., 45 degrees) with respect to the longitudinal axis 621 of the body portion 623. A second portion 652 of the plurality of intertwined fibers is oriented at an angle β of 110 - 160 degrees (e.g., 135 degrees) with respect to the longitudinal axis 621 of the annuloplasty body portion 623. The first portion 650 and the second portion 652 of the intertwined fibers impart increased longitudinal compressibility and / or stretchability to the sleeve 626.

[0231] The sleeve 626 may include a braided fabric mesh, e.g., including polyethylene terephthalate, Dacron(TM), other materials, etc. The body portion 623 (e.g., the sleeve 626) may be configured to be disposed only partially around the cardiac annulus (i.e., in a C-shape), and after being anchored in place, be contracted to circumferentially tighten the annulus. Optionally, the body portion may be configured to completely surround the annulus. To tighten the annulus, the system includes an actuatable adjustment mechanism or contraction mechanism. The adjustment mechanism or contraction mechanism may be part of one or more of the annuloplasty structure 622, the flexible elongate contraction member 30 extending along the sleeve 626, and / or other components (e.g., a catheter, etc.), and / or be coupled to one or more of the annuloplasty structure 622, the flexible elongate contraction member 30 extending along the sleeve 626, and / or other components (e.g., a catheter, etc.). The elongate contraction member 30 may include a wire, a strip, a cord, or a strap, which may include a flexible and / or superelastic material, e.g., nitinol, polyester, stainless steel, or cobalt chromium. For some applications, the contraction member 30 includes a radiopaque material. For some applications, the contraction member 30 includes a braided polyester suture (e.g., Ticron). For some applications, the contraction member 30 is coated with polytetrafluoroethylene (PTFE). For some applications, the contraction member 30 includes multiple wires intertwined to form a cord structure. The actuatable adjustment mechanism or contraction mechanism may be configured in various ways, as described in other parts of this document regarding other actuatable adjustment mechanisms and / or in any of the ways described in other documents incorporated by reference herein.

[0232] After the physician has positioned the structure 622 along the annulus and has anchored or attached the structure 622 to the annulus, the annuloplasty structure 622 is contracted using the contraction member 30. For some applications, the contraction member 30 is coupled to an actuatable contraction mechanism or adjustment mechanism, and / or is part of an actuatable contraction mechanism or adjustment mechanism, e.g., as described in other parts of this document and / or as described in U.S. Patent Application Publication 2014 / 0309661 to Sheps et al. and / or U.S. Patent Application Publication 2015 / 0272734 to Sheps et al. (which are incorporated herein by reference). Additionally, any of the methods described in the '661 and / or '734 applications may be used to accomplish the implantation of the structure 622.

[0233] Now referring to Figure 10 , Figure 10Schematic diagram of system 720 for some applications, system 720 includes structure 722 (e.g., annuloplasty structure, annuloplasty ring structure, etc.), structure 722 has a flexible body portion 723 (e.g., annuloplasty body portion, annuloplasty ring body portion, etc.), body portion 723 includes sleeve 726 and shrinkage member 30. Body portion 723 includes sleeve 726. Body portion 723 includes a flexible material, the flexible material includes first longitudinal sections 730 and second longitudinal sections 732 alternating along the longitudinal length of body portion 723.

[0234] The first longitudinal section 730 includes a flexible material, the flexible material includes a plurality of intertwined fibers. A first portion 750 of the plurality of intertwined fibers is oriented at an angle α of 20 - 70 degrees (e.g., 45 degrees) with respect to the longitudinal axis 721 of the annuloplasty ring body portion 723. A second portion 752 of the plurality of intertwined fibers is oriented at an angle β of 110 - 160 degrees (e.g., 135 degrees) with respect to the longitudinal axis 721 of the annuloplasty ring body portion 723. The first portion 750 and the second portion 752 of the intertwined fibers impart increased longitudinal compressibility and / or stretchability to the first longitudinal section 730.

[0235] The second longitudinal section 732 includes a flexible material, the flexible material includes a plurality of intertwined fibers. A third portion 754 of the plurality of intertwined fibers is oriented at an angle γ of 0 - 15 degrees (e.g., 0 degrees or 180 degrees) with respect to the longitudinal axis 721 of the annuloplasty body portion 723. A fourth portion 756 of the plurality of intertwined fibers is oriented at an angle δ of 75 - 90 degrees (e.g., 90 degrees) with respect to the longitudinal axis 721 of the annuloplasty body portion 723. The third portion 754 and the fourth portion 756 of the intertwined fibers impart increased strength, stiffness, and / or stability to the second longitudinal section 732. Thus, each of the second longitudinal sections 732 is designated to drive a corresponding tissue anchor 32 therethrough, i.e., section 732 is an anchor - designated section.

[0236] Therefore, there is generally a trade - off between (i) strength, stiffness, and / or stability and (ii) compressibility and / or stretchability. By (i) providing the anchor - designated section 732 with increased strength, stiffness, and / or stability (specifically where the anchor is anchored) and (ii) providing section 730 with increased compressibility and / or stretchability (specifically where the anchor is not anchored), structure 722 is provided with (i) sufficient strength, stiffness, and / or stability to fasten the anchor 32 to the tissue and (ii) sufficient compressibility and / or stretchability to accommodate various annulus sizes.

[0237] The sleeve 726 may include a braided fabric mesh, e.g., including polyethylene terephthalate, Dacron(TM), other materials, etc. The body portion 723 (e.g., the sleeve 726) may be configured to be disposed only partially around the cardiac annulus (i.e., in a C-shape), and after being anchored in place, be contracted to circumferentially tighten the annulus. Optionally, the body portion may be configured to completely surround the annulus. To tighten the annulus, the system includes an actuatable adjustment mechanism or a contraction mechanism. The adjustment mechanism or the contraction mechanism may be part of one or more of the annuloplasty structure 722, the flexible elongate contraction member 30 extending along the sleeve 726, and / or other components (e.g., a catheter, etc.), and / or be coupled to one or more of the annuloplasty structure 722, the flexible elongate contraction member 30 extending along the sleeve 726, and / or other components (e.g., a catheter, etc.). The elongate contraction member 30 may include a wire, a strip, a cord, or a strap, which may include a flexible and / or superelastic material, e.g., nitinol, polyester, stainless steel, or cobalt chrome. For some applications, the contraction member 30 includes a radiopaque material. For some applications, the contraction member 30 includes a braided polyester suture (e.g., Ticron). For some applications, the contraction member 30 is coated with polytetrafluoroethylene (PTFE). For some applications, the contraction member 30 includes multiple wires intertwined to form a cord structure. The actuatable adjustment mechanism or the contraction mechanism may be configured in various ways, as described in other parts of this document regarding other actuatable adjustment mechanisms and / or in any way described in other documents incorporated by reference.

[0238] After the physician has positioned the structure 722 along the annulus and has anchored or attached the structure 722 to the annulus, the annuloplasty structure 722 is contracted using the contraction member 30. For some applications, the contraction member 30 is coupled to an actuatable contraction mechanism or an adjustment mechanism, and / or is part of an actuatable contraction mechanism or an adjustment mechanism, e.g., as described in other parts of this document and / or as described in U.S. Patent Application Publication 2014 / 0309661 to Sheps et al. and / or U.S. Patent Application Publication 2015 / 0272734 to Sheps et al. (which are incorporated by reference herein). Additionally, any method described in the '661 and / or '734 applications may be used to complete the implantation of the structure 722.

[0239] Accordingly, the compressibility of the first longitudinal section 730 is greater than that of the second longitudinal section 732. Thus, the first longitudinal section 730 reduces the total compressive force imparted to the body portion 723 by the contraction member 30 during the contraction of the structure 722.

[0240] Now referring to Figure 11 , Figure 11Schematic diagram of a system 820 for some applications, the system 820 includes a structure 822 (e.g., an annuloplasty structure, an annuloplasty ring structure, etc.), the structure 822 having a flexible body portion (e.g., an annuloplasty body portion, an annuloplasty ring body portion, etc.), the body portion including a sleeve 826 and a constriction member 30. The body portion 823 includes a flexible material, the flexible material including a first longitudinal section 730 and a second longitudinal section 732, the first longitudinal section 730 and the second longitudinal section 732 alternating along the longitudinal length of the body portion 823 and along the longitudinal axis 821 of the structure 822. Except as described below, the structure 822 is generally similar to the structure 722 referenced above Figure 10 described, and like reference numerals refer to like parts.

[0241] As Figure 11 shown, the sleeve 826 defines the second longitudinal section 732 only in the area through which the deployment tissue anchor 32 passes, i.e., at the portion of the sidewall of the sleeve 826 designated to abut the annulus tissue 10. The section 732 can be arranged opposite the constriction member 30. Different from Figure 10 —— which shows that each of the sections 732 occupies a 360-degree circumference of the sleeve 726, Figure 11 the sections 732 of the structure 822 occupy a 75 - 180-degree circumference of the sleeve 826. In this way, most of the sleeve 826 includes the section 730, so the sleeve 826 exhibits a high degree of compressibility and / or expandability.

[0242] After the physician has positioned the structure 822 along the annulus and has anchored or attached the structure 822 to the annulus, the annuloplasty structure 822 is constricted using the constriction member 30. For some applications, the constriction member 30 is coupled to an actuatable constriction mechanism or adjustment mechanism, and / or is part of an actuatable constriction mechanism or adjustment mechanism, e.g., as described elsewhere herein and / or as described in U.S. Patent Application Publication 2014 / 0309661 to Sheps et al. and / or U.S. Patent Application Publication 2015 / 0272734 to Sheps et al. (which are incorporated herein by reference). Additionally, any method described in the '661 and / or '734 applications can be used to complete the implantation of the structure 822.

[0243] Now refer to Figure 12 , Figure 12FIG. 0 is a schematic illustration of a system 920 for some applications. The system 920 includes a structure 922 (e.g., an annuloplasty structure, an annuloplasty ring structure, etc.). The structure 922 has a flexible body portion 923 (e.g., an annuloplasty body portion, an annuloplasty ring body portion, etc.). The body portion 923 includes a sleeve 926 and a constriction member 30. The body portion 923 includes a flexible material that includes a first longitudinal section 932 and a second longitudinal section 930. The first longitudinal section 932 and the second longitudinal section 930 alternate along the longitudinal length of the body portion 923 and along the longitudinal axis 921 of the structure 922.

[0244] Each of the first sections 932 defines a compressible section having a compressible section wall with a first thickness T1 of 0.05 - 0.1 mm (e.g., 0.07 mm). Each of the second sections 930 defines an anchor-designated section having an anchor-designated wall with a second thickness T2 of 0.15 - 0.2 mm (e.g., 0.18 mm). The second thickness T2 is greater than the first thickness T1, and the second thickness T2 thus imparts stiffness and / or stability to the corresponding section 930 through which the corresponding anchor 32 is deployed in the sleeve 926. For some applications, the sections 930 are marked with radio-opaque markers.

[0245] The first longitudinal section 932 has a higher degree of compressibility than the second longitudinal section 930 due to its corresponding thickness. Thus, the first longitudinal section 932 reduces the total compressive force applied to the body portion 923 through the constriction member 30 during the contraction of the structure 922.

[0246] The sleeve 926 may include a braided fabric mesh, e.g., including polyethylene terephthalate, Dacron(TM), other materials, etc. The body portion 923 (e.g., the sleeve 926) may be configured to be disposed only partially around the cardiac annulus (i.e., in a C-shape), and after being anchored in place, is contracted to circumferentially tighten the annulus. Optionally, the body portion may be configured to be disposed completely around the annulus. To tighten the annulus, the system includes an actuatable adjustment mechanism or contraction mechanism. The adjustment mechanism or contraction mechanism may be part of one or more of the annuloplasty structure 922, the flexible elongate contraction member 30 extending along the sleeve 926, and / or other components (e.g., a catheter, etc.), and / or coupled to one or more of the annuloplasty structure 922, the flexible elongate contraction member 30 extending along the sleeve 926, and / or other components (e.g., a catheter, etc.). The elongate contraction member 30 may include a wire, a strip, a cord, or a strap, which may include a flexible and / or superelastic material, e.g., nitinol, polyester, stainless steel, or cobalt chromium. For some applications, the contraction member 30 includes a radiopaque material. For some applications, the contraction member 30 includes a braided polyester suture (e.g., Ticron). For some applications, the contraction member 30 is coated with polytetrafluoroethylene (PTFE). For some applications, the contraction member 30 includes multiple wires intertwined to form a cord structure. The actuatable adjustment mechanism or contraction mechanism may be configured in various ways, as described elsewhere in this document regarding other actuatable adjustment mechanisms and / or in any way described in other documents incorporated by reference.

[0247] After the physician has positioned the structure 922 along the annulus and has anchored or attached the structure 922 to the annulus, the annuloplasty structure 922 is contracted using the contraction member 30. For some applications, the contraction member 30 is coupled to an actuatable contraction mechanism or adjustment mechanism, and / or is part of an actuatable contraction mechanism or adjustment mechanism, e.g., as described elsewhere in this document and / or as described in U.S. Patent Application Publication 2014 / 0309661 to Sheps et al. and / or U.S. Patent Application Publication 2015 / 0272734 to Sheps et al. (which are incorporated herein by reference). Additionally, any method described in the '661 and / or '734 applications may be used to accomplish the implantation of the structure 922.

[0248] Now referring to Figure 13A -C, Figure 13A -C is a schematic diagram of a system 1000 according to some applications, the system 1000 including a structure 1020 (e.g., an annuloplasty structure, an annuloplasty ring structure, etc.), the structure 1020 having a flexible body portion 1023 (e.g., an annuloplasty body portion, an annuloplasty ring body portion, etc.), the body portion 1023 including a sleeve 26 and a contraction member 30. Note that the annuloplasty structure 1020 may include as referred to hereinFigures 1-12 Any annuloplasty structure or annuloplasty ring structure described. Additionally, the structure 1020 may include a constriction mechanism 1040 that includes and / or is coupled to a constriction member 30 as described in U.S. Patent Application Publication 2014 / 0309661 to Sheps et al. and / or U.S. Patent Application Publication 2015 / 0272734 to Sheps et al. (which are incorporated herein by reference). Additionally, any method described in the '661 and / or '734 applications may be used to effect implantation of the structure 1020.

[0249] In Figure 13A , an anchor delivery system 1050 or other attachment system may be used to anchor or attach a first section of the annuloplasty body portion 1023 of the annuloplasty structure 1020, for example, by deploying one or more tissue anchors 32 through the sleeve 26 from within the lumen of the sleeve 26 into the annulus tissue 10.

[0250] In Figure 13B , the anchor delivery system 1050 is used to compress a second section 1060 of the annuloplasty body portion 1023 toward the first section of the annuloplasty body portion 1023. For some applications, the system 1050 may be reversibly engaged and reversibly coupled to a portion of the sleeve 26 during compression of the second section 1060. For example, the anchor driver 1052 is capable of reversibly ensnaring a portion of the sleeve 26.

[0251] In Figure 13C , the anchor delivery system 1050 is used to drive tissue anchors 32 through the currently compressed second section 1060 of the body portion 1023. For some applications, the tissue anchors may be delivered downstream of the section 1060. Note that Figure 13A -C shows by way of example and not limitation the compression of only a single section 1060 of the body portion 1023. Sequential anchoring or attachment of the sleeve 26 to tissue may be done immediately or shortly after compression of the corresponding section of the body portion 1023, which enables the operator to alternate between compression and anchoring and also enables the operator to control the overall amount of compression of the sleeve 26. In this way, the system 1000 minimizes the likelihood of any excess sleeve 26 interfering with the heart valve. Additionally, using the system 1000, the physician does not need to measure the size of the annulus before positioning the annuloplasty ring structure 1020. In this way, the structure 1020 accommodates and adapts to all native annulus sizes.

[0252] Figures 14-15 is a corresponding flowchart of at least some of the steps of the corresponding technique according to the corresponding application herein referenced Figures 1-13C described.

[0253] Figure 14Disclosed is a structure for delivering in an elongated state (e.g., an annuloplasty structure, an annuloplasty ring structure, etc.) and a method 1200 for subsequently shortening the structure before contraction. In step 1210, the structure or "annuloplasty structure" (which can be any annuloplasty structure or similar structure described herein) is delivered to the annulus and / or atrium in an elongated state. In step 1220, the annuloplasty structure is shortened without relying on the contraction member 30 while maintaining the integrity of the main body portion of the annuloplasty structure (e.g., by not cutting or severing any part of the main body portion).

[0254] For some applications, the structure is anchored to the annulus tissue (step 1230) only after the annuloplasty structure has been shortened as determined by the operator. Optionally, in accordance with step 1240, the shortening and anchoring of the annuloplasty structure are alternated. This means that the annuloplasty structure can be partially shortened and then anchored to the annulus tissue using a first tissue anchor. Subsequently, the annuloplasty structure can be partially shortened again and then anchored to the annulus tissue using a second tissue anchor. Finally, in step 1250, the annulus is reshaped by contracting the annuloplasty structure using the contraction member 30.

[0255] Now refer to Figure 7 Figures 8, 13A - C, 14, and 17A - F. Note that the method 1200 described herein with reference to Figure 14 is applicable to the systems and devices described herein with reference to Figure 7 Figures 8, 13A - C, and 17A - F.

[0256] Figure 15 Disclosed is a structure for delivering in a shortened state (e.g., an annuloplasty structure, an annuloplasty ring structure, etc.) and a method 1300 for subsequently expanding the structure before contraction. In step 1310, the annuloplasty structure (which can be any annuloplasty structure or similar structure described herein) is delivered to the annulus and / or atrium in a shortened state. In step 1320, the annuloplasty structure is at least partially expanded without relying on the contraction member 30 while maintaining the integrity of the main body portion of the annuloplasty structure (e.g., by not cutting or severing any part of the main body portion).

[0257] For some applications, the structure is anchored to the annulus tissue (step 1330) only after the annuloplasty structure has been expanded as determined by the operator. Optionally, in accordance with step 1340, the expansion and anchoring of the annuloplasty structure are alternated. This means that the annuloplasty structure can be partially expanded and then anchored to the annulus tissue using a first tissue anchor. Subsequently, the annuloplasty structure can be partially expanded again and then anchored to the annulus tissue using a second tissue anchor. Finally, in step 1350, the annulus is reshaped by contracting the annuloplasty structure using the contraction member 30.

[0258] Now refer to Figures 1-5 Figures 6A - D, 15, 18A - C, and 19. Note that the method 1200 described herein may be applicable to the systems and devices described in reference to Figure 15 Figures 6A - D, 18A - C, and 19 herein Figures 1-5 Figures 6A - D, 18A - C, and 19

[0259] Now refer to Figure 16 , Figure 16 which is a schematic diagram of a system 1600 according to some applications. The system 1600 includes a structure 1622 (e.g., an annuloplasty structure, an annuloplasty ring structure, etc.), and the structure 1622 has a flexible body portion 1623 (e.g., an annuloplasty body portion, an annuloplasty ring body portion, etc.). The body portion 1623 includes a sleeve 1626 and a constriction member 30. The sleeve 1626 of the body portion 1623 includes a first flexible material and is shaped and configured to define a plurality of windows 1628, each of which is covered with a corresponding covering 1630. The covering 1630 includes a second flexible material that is more stretchable and / or compressible than the first flexible material of the sleeve 1626. The sleeve 1626 thus defines a plurality of anchor - designated sections or attachment sections 1625, which alternate with a plurality of compressible sections 1624 defined by the windows 1628 along the longitudinal axis 1621 of the structure 1622. As shown, corresponding tissue anchors 32 may anchor the structure 1622 to the annulus tissue 10 at each anchor - designated section 1625

[0260] In some applications, each window 1628 and each compressible section 1624 have a longest dimension L7 of 12 - 16 mm, such as 14 mm

[0261] Now refer to Figure 10 and 16 . For some applications Figure 16 each covering 1630 of may include the same material as the first longitudinal section 730 and may include a flexible material containing a plurality of intertwined fibers. The first part 750 and the second part 752 of the intertwined fibers impart to the first longitudinal section 730 and thus to Figure 16 the covering 1630 of increased longitudinal compressibility and / or stretchability. Each anchor - designated section 1625 may include the same material as the second longitudinal section 732, which includes a flexible material containing a plurality of intertwined fibers. The third part 754 and the fourth part 756 of the intertwined fibers impart to the second longitudinal section 732 and thus to the anchor - designated section 1625 increased stiffness and / or stability. For some applications, each section 1625 is marked with a radiopaque marker

[0262] The covering 1630 has a higher degree of compressibility and / or stretchability than the designated section 1625 of the anchor due to its corresponding intertwined fibers. Thus, the window 1628 and the covering 1630 reduce the total compressive force imparted to the body portion 1623 by the constriction member 30 during the constriction of the structure 1622.

[0263] Now referring to Figure 12 and 16 . For some applications, Figure 16 each covering 1630 of Figure 12 may include the same material as the first section 932 of

[0264] which may define a compressible section having a first thickness T1 of 0.05 - 0.1 mm (e.g., 0.07 mm). Each designated section or attachment section 1625 of the anchor may include the same material as the second section 930 of

[0265] which may have a second thickness T2 of 0.15 - 0.2 mm (e.g., 0.18 mm). The second thickness T2 may be greater than the first thickness T1, and the second thickness T2 may be configured to impart rigidity and / or stability to the corresponding section through which the deployment of the sleeve 1626 corresponding anchor passes. For some applications, each section 1625 is marked with a radiopaque marker. Figure 16The sleeve 1626 may include a woven fabric mesh, e.g., including polyethylene terephthalate, Dacron(TM), other materials, etc. The body portion 1623 (e.g., the sleeve 1626) may be configured to be disposed only partially around the cardiac annulus (i.e., in a C-shape), and after being anchored in place, be contracted to circumferentially tighten the annulus. Optionally, the body portion may be configured to be disposed completely around the annulus. To tighten the annulus, the system includes an actuatable adjustment mechanism or contraction mechanism. The adjustment mechanism or contraction mechanism may be part of one or more of the annuloplasty structure 1622, the flexible elongate contraction member 30 extending along the sleeve 1626, and / or other components, and / or be coupled to one or more of the annuloplasty structure 1622, the flexible elongate contraction member 30 extending along the sleeve 1626, and / or other components. The elongate contraction member 30 may include a wire, a strip, a cord, or a strap, which may include a flexible and / or superelastic material, e.g., nitinol, polyester, stainless steel, or cobalt chrome. For some applications, the contraction member 30 includes a radiopaque material. For some applications, the contraction member 30 includes a braided polyester suture (e.g., Ticron). For some applications, the contraction member 30 is coated with polytetrafluoroethylene (PTFE). For some applications, the contraction member 30 includes multiple wires intertwined to form a cord structure. The actuatable adjustment mechanism or contraction mechanism may be configured in various ways, as described in other parts of this document regarding other actuatable adjustment mechanisms and / or in any way described in other documents incorporated by reference.

[0266] After the physician has positioned the structure 1622 along the annulus and has anchored or attached the structure 1622 to the annulus, the annuloplasty structure 1622 is contracted using the contraction member 30. For some applications, the contraction member 30 is coupled to an actuatable contraction mechanism or adjustment mechanism, and / or is part of an actuatable contraction mechanism or adjustment mechanism, e.g., as described in other parts of this document and / or as described in U.S. Patent Application Publication 2014 / 0309661 to Sheps et al. and / or U.S. Patent Application Publication 2015 / 0272734 to Sheps et al., which are incorporated by reference herein. Additionally, any method described in the '661 and / or '734 applications may be used to complete the implantation of the structure 922.

[0267] Now refer to Figure 17A -F, Figure 17A-FIG. F is a schematic illustration of a system 1700 for some applications, the system 1700 including a structure 1722 (e.g., an annuloplasty structure, an annuloplasty ring structure, etc.), the structure 1722 having a main body portion 1723 that includes a flexible sleeve 1726 and a constriction member 30. The sleeve 1726 of the main body portion 1723 includes a flexible material that is shaped and configured to define a lumen therethrough. As shown, the structure 1722 includes one or more connection segments 1730, e.g., 1730a, 1730b, and 1730c. By way of example and not limitation, the structure 1722 is shown including three segments 1730. Note that the structure 1722 can include any number of segments 1730. The segments 1730 are removably coupled to the main body portion 1723.

[0268] There is provided a structure 1722 that includes any number of connection segments 1730 coupled to the main body portion 1723 such that the structure 1722 can be delivered to a patient's annulus in an elongated state and any number of the connection segments 1730 can subsequently be decoupled from the main body portion 1723. After a sufficient amount of the structure 1722 (i.e., the main body portion 1723 and any number of the connection segments 1730) is anchored to the annulus tissue 10, a physician can elect to decouple the remaining connection segments 1730 and remove them from the patient's body. In this manner, the system 1700 minimizes the likelihood of any excess sleeve 1726 interfering with the heart valve. Additionally, using the system 1700, a physician does not need to measure the size of the annulus prior to positioning the annuloplasty ring structure 1722. In this manner, the structure 1722 accommodates and fits all native annulus sizes.

[0269] The main body portion 1723 as well as the connection segments 1730 include the flexible sleeve 1726.

[0270] The sleeve 1726 may include a woven fabric mesh, for example, including polyethylene terephthalate, for example, Dacron(TM). The body portion 1723 (e.g., the sleeve 1726) may be configured to be disposed only partially around the cardiac annulus (i.e., in a C-shape), and after being anchored in place, is contracted to circumferentially tighten the annulus. Optionally, the body portion may be configured to completely surround the annulus. To tighten the annulus, the system includes an actuatable adjustment mechanism or a contraction mechanism. The adjustment mechanism or the contraction mechanism may be part of one or more of the annuloplasty structure 1722, the flexible elongate contraction member 30 extending along the sleeve 1726, and / or other components, and / or coupled to one or more of the annuloplasty structure 1722, the flexible elongate contraction member 30 extending along the sleeve 1726, and / or other components. The elongate contraction member 30 may include a wire, a strip, a cord, or a tape, which may include a flexible and / or superelastic material, such as nitinol, polyester, stainless steel, or cobalt chrome. For some applications, the contraction member 30 includes a radiopaque material. For some applications, the contraction member 30 includes a braided polyester suture (e.g., Ticron). For some applications, the contraction member 30 is coated with polytetrafluoroethylene (PTFE). For some applications, the contraction member 30 includes multiple wires intertwined to form a cord structure. The actuatable adjustment mechanism or the contraction mechanism may be configured in various ways, as described in other parts of this document regarding other actuatable adjustment mechanisms and / or in any way described in other documents incorporated by reference.

[0271] The contraction member 30 extends along the longitudinal length of the main body portion 1723 and along each connecting segment 1730. The contraction member 30 can be used to contract the main body portion 1723 and the connecting segment 1730 along the longitudinal axis 1721 of the structure 1722.

[0272] The first end of the main body portion 1723, for example, the proximal end, may include a first coupling 1750. A second coupling 1752 may be coupled to the first end, for example, the distal end, of the first connecting segment 1730a, which is disposed adjacent to the first coupling 1750 of the first end of the main body portion 1723. The first coupling 1750 and the second coupling 1752 are shaped and configured to cooperate with each other.

[0273] A third coupling (e.g., another coupling 1750) may be coupled to the second end, for example, the proximal end, of the first connecting segment 1730a. A fourth coupling (e.g., another coupling 1752) may be coupled to the first end (e.g., the distal end) of the second connecting segment 1730b disposed adjacent to the first connecting segment 1730a.

[0274] The first coupling member 1750 is shaped and configured to define a first cavity and includes one or more radially movable protrusions 1751. The second coupling member 1752 is shaped and configured to define a second cavity and a negative space 1753 that is shaped and configured to receive the one or more radially movable protrusions 1751.

[0275] For some applications, the radially movable protrusion 1751 of the first coupling member 1750 includes a single circular protrusion, and the negative space 1753 of the second coupling member 1752 is shaped and configured to define a single circular groove.

[0276] For some applications, the radially movable protrusion 1751 is biased to radially collapse inwardly in the absence of an applied force thereto. For some applications, the radially movable protrusion 1751 is not biased to radially collapse inwardly and is movable in response to an applied force thereto. For example, the walls defining the negative space 1753 of the second coupling member 1752 are shaped and configured to enable the one or more protrusions 1751 to slide out of engagement in one direction in response to a force applied to the connection segment 1730 (e.g., a tensile force applied to the connection segment 1730).

[0277] System 1700 includes an anti-disengagement element 1740, as Figure 17A shown. The anti-disengagement element extends longitudinally along at least the first coupling member 1750 and the second coupling member 1752 to prevent disengagement of the first coupling member 1750 and the second coupling member 1752. During delivery of the structure 1722, the anti-disengagement element 1740 extends along all of the connection segments 1730 and along a portion of the main body portion 1723 and prevents the connection segments 1730 from disengaging from each other and from the main body portion 1723.

[0278] For some applications, the anti-disengagement element 1740 includes an elongate tube 1742. The outer surface of the tube 1742 is sized to abut or urge against one or more of the protrusions 1751 to maintain the protrusions 1751 within the negative space 1753 and prevent disengagement of the first coupling member 1750 and the second coupling member 1752.

[0279] For applications in which one or more of the protrusions 1751 are biased to move radially inwardly, the outer surface of the tube 1742 of the anti-disengagement element 1740 abuts and urges against one or more of the protrusions 1751 of the first coupling member 1750 and maintains the protrusions 1751 within the negative space 1753 of the second coupling member 1752 to prevent disengagement of the first coupling member 1750 and the second coupling member 1752 as a portion of the elongate tube 1742 passes through the first cavity of the first coupling member 1750 and the second cavity of the second coupling member 1752, respectively.

[0280] For some applications, the tube 1742 of the anti-disconnection element 1740 includes the tube of the anchor delivery system 1743. For some applications, the anchor delivery system 1743 includes a deployment manipulator, an anchor driver, and a deployment element, as described in U.S. Patent Application Publication 2014 / 0309661 to Sheps et al. and / or U.S. Patent Application Publication 2015 / 0272734 to Sheps et al. (which are incorporated herein by reference).

[0281] For some applications, the anti-disconnection element 1740 includes an overtube 1744, e.g., a steerable catheter, which is used to deliver the annuloplasty structure 1722. The inner diameter of the overtube 1744 is sized to maintain the connection of the connectors 1750 and 1752 when a portion of the overtube 1744 surrounds the first connector 1750 and the second connector 1752.

[0282] For some applications, the anti-disconnection element 1740 includes a shrinkage member 30. Since the shrinkage member 30 extends along the main body portion 1723 and the connecting segment 1730, e.g., through, the shrinkage member 30 maintains the connection of the first connector 1750 and the second connector 1752.

[0283] Figure 17B An anchor delivery system 1743 is shown delivering a tissue anchor 32 through a portion of the sleeve 1726 of the main body portion 1723 and into the heart tissue 10. The system 1743 includes an anchor driver 1745 that is reversibly coupled to the anchor 32 and decouples from it after the anchor 32 is deployed.

[0284] After the main body portion 1723 is anchored to the heart tissue 10, the anchor delivery system 1743 is moved to properly position the first connecting segment 1730a at the heart tissue 10 where it is to be anchored. As Figure 17C shown, a portion of the tube 1742 of the system 1743 is moved away from the first connector 1750 and the second connector 1752.

[0285] For applications in which one or more protrusions 1751 of the first connector 1750 are biased to move radially inwardly, in the absence of the anti-disconnection element 1740, the protrusions 1751 move radially inwardly, as Figure 17C shown.

[0286] Note that for some applications, one or more protrusions 1751 of the first coupling 1750 are not biased to move radially inwardly and are only movable in response to a force applied thereto (e.g., a tensile force applied to segment 1730a from the proximal direction). In such applications, the one or more protrusions 1751 do not move radially inwardly in the absence of a thrust force applied to them by the outer surface of the tube 1742.

[0287] In either application, even if the tube 1742 is not disposed within the corresponding elements of the couplings 1750 and 1752 and thus the one or more protrusions 1751 are movable out of the negative space 1753, the constriction member 30 maintains the connection between the segment 1730a and the main body portion 1723. In this way, the constriction member 30 acts as a disconnection prevention element 1740. Additionally, since the segment 1730a is anchored to the tissue 10, the connection between the segment 1730 and the main body portion 1723 is maintained.

[0288] In Figure 17D the above, in the manner described with reference to Figure 17C the second connecting segment 1730b is anchored to the heart tissue 10 by the anchor delivery system 1743. Thus, since the tube 1742 of the disconnection prevention element 1740 extends beyond the cavity of the couplings 1750 and 1752 that connect the first connecting segment 1730a and the second connecting segment 1730b, one or more protrusions 1751 of the coupling 1750 of the first connecting segment 1730a are movable out of the negative space 1753 of the coupling 1752 of the second connecting segment 1730b.

[0289] As referred to above with reference to Figure 17C it is noted that for applications in which one or more protrusions 1751 of the first coupling 1750 are biased to move radially inwardly, in the absence of the disconnection prevention element 1740, the protrusions 1751 move radially inwardly.

[0290] Additionally, as Figure 17C noted, note that for some applications, one or more protrusions 1751 of the first coupling 1750 are not biased to move radially inwardly and are only movable in response to a force applied thereto (e.g., a tensile force applied to segment 1730a from the proximal direction). In such applications, the one or more protrusions 1751 do not move radially inwardly in the absence of a thrust force applied to them by the outer surface of the tube 1742.

[0291] Figure 17E shows the disconnection of the third connecting segment 1730c from the second connecting segment 1730b.

[0292] As referred to above with reference to Figure 17CIt is pointed out that for applications in which one or more protrusions 1751 of the first coupling member 1750 are biased to move radially inwardly, in the absence of the anti-disconnection element 1740, the protrusions 1751 move radially inwardly.

[0293] In addition, as Figure 17C is pointed out, note that for some applications, one or more protrusions 1751 of the first coupling member 1750 are not biased to move radially inwardly, but are merely movable in response to a force applied thereto (e.g., a tensile force applied to the segment 1730c from the proximal direction). In such applications, one or more protrusions 1751 do not move radially inwardly in the absence of a thrust force applied to them by the outer surface of the tube 1742.

[0294] In either application, after one or more protrusions 1751 of the coupling member 1750 of the second connection segment 1730b have moved radially out of the negative space 1753 of the coupling member 1752 of the third connection segment 1730c, the third connection segment 1730c can be disconnected from the second connection segment.

[0295] As shown, the third connection segment 1730c and any other additional connection segments 1730 disposed proximal to the third connection segment 1730c move proximally away from the main body portion 1723 and the first connection segment 1730a and the second connection segment 1730b coupled to the heart tissue. As shown, the third connection segment 1730c and any other additional connection segments 1730 disposed proximal to the third connection segment 1730c are pulled along the contraction member 30.

[0296] Figure 17E The structure 1722 after contraction is shown. After removing the third connection segment 1730c and any other additional connection segments 1730 disposed proximal to the third connection segment 1730c from the body of the subject, the excess portion of the contraction member 30 is cut off and removed from the patient's body. The bead or locking member 1760 is coupled to the contraction member 30.

[0297] After the physician has positioned the structure 1722 along the annulus and has removed any number of connection segments 1730, the annulus forming structure 1722 can be contracted using the contraction member 30, e.g., by actuating the contraction mechanism 1040, which includes and / or is coupled to the contraction member 30, as described in U.S. Patent Application Publication 2014 / 0309661 to Sheps et al. and / or U.S. Patent Application Publication 2015 / 0272734 to Sheps et al. (which are incorporated herein by reference). Additionally, any method described in the '661 and / or '734 applications can be used to complete the implantation of the structure 1722.

[0298] Now refer to Figure 18A-C, Figure 18A -C is a schematic diagram of an exemplary system 1800 for some applications. System 1800 includes a variable stretchability structure 1820 (e.g., an annuloplasty structure, an annuloplasty ring structure, etc.), which has a flexible body portion 1823 (e.g., an annuloplasty body portion, an annuloplasty ring body portion, etc.). The body portion 1823 includes a sleeve 1826 and a contraction member 30. The annuloplasty structure 1820 may include any annuloplasty structure or annuloplasty ring structure described herein with reference to Figures 1-17F any of the annuloplasty structures or annuloplasty ring structures described. Additionally, for some applications, the structure 1820 may include an actuatable contraction mechanism that includes and / or is coupled to the contraction member 30, as described in U.S. Patent Application Publication 2014 / 0309661 to Sheps et al. and / or U.S. Patent Application Publication 2015 / 0272734 to Sheps et al. (which are incorporated herein by reference). Additionally, any method described in the '661 and / or '734 applications may be used to effect the implantation of the structure 1820.

[0299] The sleeve 1826 may include a woven fabric mesh, e.g., including polyethylene terephthalate, Dacron(TM), other materials, etc. The body portion 1823 (e.g., the sleeve 1826) may be configured to be disposed only partially around the cardiac annulus (i.e., in a C-shape), and after being anchored in place, is contracted to circumferentially tighten the annulus. Optionally, the body portion may be configured to be disposed completely around the annulus (e.g., a full ring or a closed ring). To tighten the annulus, the system includes an actuatable adjustment mechanism or contraction mechanism. The adjustment mechanism or contraction mechanism may be part of one or more of the annuloplasty structure 1820, a flexible elongate contraction member 30 extending along the sleeve 1826, and / or other components, and / or is coupled to one or more of the annuloplasty structure 1820, a flexible elongate contraction member 30 extending along the sleeve 1826, and / or other components. The elongate contraction member 30 may include a wire, a strip, a cord, or a ribbon, which may include a flexible and / or superelastic material, e.g., nitinol, polyester, stainless steel, or cobalt chrome. For some applications, the contraction member 30 includes a radiopaque material. For some applications, the contraction member 30 includes a braided polyester suture (e.g., Ticron). For some applications, the contraction member 30 is coated, such as coated with polytetrafluoroethylene (PTFE) or other polymers. For some applications, the contraction member 30 includes multiple wires intertwined to form a cord structure. The actuatable adjustment mechanism or contraction mechanism may be configured in various ways, as described elsewhere herein regarding other actuatable adjustment mechanisms and / or any way described in other documents incorporated by reference.

[0300] For some applications, the sleeve 1826 is marked with one or more radiopaque markers. The sleeve 1826 can include a flexible sleeve 1826 that is shaped and configured to define a lumen therethrough.

[0301] In Figure 18A an anchoring member delivery system 1050 or other attachment system can be used to anchor or attach a first section of the annuloplasty body portion 1823 of the annuloplasty structure 1820, for example, by deploying one or more tissue anchors 32 through the sleeve 1826 from within the lumen of the sleeve 1826 to the annulus tissue 10. Techniques for deploying the anchors 32 through the sleeve 1826 can be practiced in combination with the techniques described in Sheps' WO 2013 / 069019, which is incorporated herein by reference. Other fastening or attachment devices (e.g., staples, fasteners, clamps, screws, adhesives, etc.) can be used additionally or alternatively.

[0302] In Figure 18B an anchoring member delivery system 1050 is used to deliver and anchor or attach additional segments of the body portion 1823 of the annuloplasty structure 1820. As shown, the body portion 1823 includes (1) a first section 1822 having a first degree of stretchability, and (2) a second section 1824 having a second degree of stretchability that is greater than the first degree of stretchability. For some applications, the system 1050 can reversibly engage and reversibly grip a portion of the sleeve 1826 during stretching of the second section 1824, for example, to facilitate pulling of the sleeve 1826.

[0303] The corresponding lengths of each of the first section 1822 and the second section 1824 can be controlled by the operator.

[0304] For some applications, the entire body portion 1823 has increasing flexibility from the distal end of the body portion 1823 toward the proximal end of the body portion 1823. That is, the second section 1824 can be longer and / or assume a greater percentage of the body portion 1823 than Figure 18B shown in -C, by way of example and not limitation.

[0305] In the context of this application (including the claims), "proximal" refers to the part of a structure that is closer to the orifice through which the structure is introduced, while "distal" refers to the part of the structure that is farther from the orifice through which the structure is introduced.

[0306] In addition, for some applications, the increased stretchability of segment 1824 imparts increased compressibility to segment 1824. For example, the body portion 1823 can be delivered to the heart in an elongated state, partially anchored to the annulus, and then after anchoring, the elongated structure can be shortened in real time during the implantation procedure (e.g., by compression) while maintaining the integrity of the body portion of the structure or annuloplasty ring structure (e.g., by not cutting or severing any portion of the body portion), and after shortening, the structure or annuloplasty ring structure can be contracted by the contraction member 30 to contract and reshape the patient's annulus. For example, for some applications, after the first segment 1822 has been fixed to a first length of the annulus tissue, it is obvious to the physician that the path length of the remaining annulus tissue is shorter than initially expected. With the structure 1820 having a segment 1824 with increased compressibility, the physician can compress the remaining sections of the second segment 1824 to accommodate the path length of the remaining annulus tissue.

[0307] After the physician has fixed (e.g., typically by anchoring with the anchor 32 and / or fastening with some other attachment device) the first segment 1822 to the annulus, the physician then stretches the second segment 1824 to accommodate the remaining portion of the annulus to which the structure 1820 has not yet been anchored. For example, for some applications, after the first segment 1822 has been fixed to a first length of the annulus tissue, it is obvious to the physician that the path length of the remaining annulus tissue is longer than initially expected. With the structure 1820 having a segment 1824 with increased stretchability, the physician can stretch the second segment 1824 to accommodate the path length of the remaining annulus tissue. After stretching the second segment 1824, the second segment 1824 is fixed to the annulus (e.g., one or more anchors 32 are deployed through the sleeve 1826 of the second segment 1824 to fix the second segment 1824 to the annulus). In this way, a shorter annuloplasty structure can be delivered to the annulus and only stretched to a longer length after initially being anchored to the annulus. Thus, the structure 1820 includes a partially stretchable or partially elastic structure 1820. For some applications, as the body segment 1824 of the body portion 1823 is stretched, the diameter of the segment 1824 gradually and progressively decreases.

[0308] As Figure 18B shown in -C, the first segment 1822 is designated for implantation near the anterolateral commissure and between approximately P2 (by way of example and not limitation), while the second segment 1824 is designated for implantation between approximately P2 (by way of example and not limitation) and the posterolateral commissure. Figure 18CShows the various diameters of the sleeve 1826. Note that although only the second segment 1824 is shown as being more stretchable than the first segment 1822, applications include annuloplasty structures in which the body portion has alternating segments of variable stretchability. Segment 1824 can be designated for implantation at any location along the annulus.

[0309] Since the degree of stretchability of the first segment 1822 is lower than that of the second segment 1824, after stretching and typically before the structure 1820 contracts, D1 of the first segment 1822 is generally, but not necessarily, greater than the diameter D2 of the second segment 1824.

[0310] For some applications, the diameter of segment 1824 does not decrease after stretching. In such applications, the diameter of segment 1824 remains the same as or similar to the diameter of segment 1822. For some applications, only the inner diameter can decrease in response to the stretching of segment 1824. For some applications, only the outer diameter can decrease in response to the stretching of segment 1824. For any of these applications, an appropriate material can be used that helps control the diameter of a given section of the structure 1820 in response to the application of a tensile force, stretching force, or compressive force. These appropriate materials also help control the wall thickness of the sleeve 1826.

[0311] Generally, the second segment 1824 is more stretchable overall than the first segment 1822. For some applications, the second segment 1824 is always uniform. This means that the entire segment 1824 can stretch by an equal measure along the entire length of the segment 1824. For some applications, the second segment 1824 can have sections of higher stretchability and sections of lower stretchability. For such applications, the second segment 1824 can have increasing stretchability along its length, or the second segment 1824 can have sections of alternating variable stretchability along the length of the second segment 1824.

[0312] As Figure 18B -C shows by way of example and not limitation, the second segment 1824 occupies approximately one-third of the body portion 1824. Note that segments 1822 and 1824 can occupy any proportion. For example, segment 1824 can occupy approximately 50% or 75% of the body portion 1823. For some applications, the body portion 1823 can have increasing stretchability along the entire length of the body portion 1823.

[0313] Although Figure 18A-C shows a sleeve 1826 including a braided fabric, but the sleeve 1826 can include other materials, such as flexible tubular plastic, e.g., having variable stretchability or variable elasticity. For some applications, the sleeve can include a helical design, e.g., the sleeve can include a flexible tubular plastic having a helical design. For some applications, the helix can have a variable pitch and / or diameter to assist in varying the flexibility of different regions of the sleeve.

[0314] Now refer to Figure 18A -C. For the first section 1822, (1) the anchors 32 (and / or other attachment devices) can be deployed at equal or similar distances from each other (e.g., a distance of 4 - 10 mm between each anchor / attachment device), and (2) sleeves 1826 of equal or similar length can be disposed between each anchor / attachment device. For the second section 1824, (1) the anchors 32 (or other attachment devices) can be deployed at equal or similar distances from each other, and (2) due to the sleeve 1826 being stretched, a shorter length of the sleeve 1826 compared to the length of the sleeve 1826 used to span the distance between the anchors 32 in the first section 1822 can be used to span the distance between each anchor 32 in the second section 1824.

[0315] That is, for the method of implanting the implant structure 1820, the first section 1822 can be implanted (or other attachment devices can be used) by driving the anchors 32 through the sleeve 1826 as shown in Figure 18A . A first section of the sleeve 1826 of the first section 1822 can be released from the anchor delivery system 1050. Then the first section can be positioned along the tissue 10, and another anchor 32 can be driven through the sleeve 1826 using the anchor driver 1052 to fix the first section of the sleeve 1826 to the tissue 10 (or other attachment devices can be used to fix / attach this section to the tissue). Then another section 1827 of the sleeve 1826 of the first section 1822 can be released from the anchor delivery system 1050 and positioned along the tissue 10, and another anchor 32a can be driven through the sleeve 1826 (as shown in Figure 18B(as shown in ), or another attachment device may be utilized to secure / attach the additional section 1827 to the tissue). After the physician implants the first section 1822, the physician may expose the section 1829 of the second section 1824 by releasing the section 1829 from the delivery system 1050. The length of the section 1829 of the section 1824 released from the system 1050 is less than the length of the section 1827 of the section 1822 released from the system 1050. The physician may then stretch the section 1829 to a stretched state, the length of which is greater than the length of the section 1829 before stretching when released from the delivery system 1050. The physician may position the stretched section 1829 along the tissue 10 and may secure the section 1829 of the second section 1824 to the tissue 10, e.g., by an attachment device such as driving a tissue anchor 32d at a distance from the previous anchor 32c equal to or generally similar to the distance between the anchors 32a and 32b used to anchor the section 1827 of the first section 1822.

[0316] Due to the increased flexibility of the second section 1824, (1) a shorter length of the sleeve 1826 may be progressively released from the delivery system 1050 to span the distance between the attachment devices / anchors 32 used to secure the second section 1824, and then (2) a certain length of the sleeve 1824 may be released from the delivery system 1050 to span the same distance between the attachment devices / anchors 32 of the first section 1822.

[0317] That is, if the physician stretches the sleeve 1826 at the section 1829 of the second section 1824 to span the same distance between the respective attachment devices / anchors 32, a shorter length of the sleeve 1826 is released from the delivery system 1050 before stretching between the respective anchors 32 in the second section 1824, the length being shorter than the length of the sleeve 1826 released from the delivery system 1050 to span the distance between the anchors 32 in the first section 1822.

[0318] For some applications, stretching the section 1824 straightens the sleeve 1826 before anchoring the sleeve 1826. This straightening of the sleeve 1826 by stretching advantageously reduces the likelihood of the sleeve 1826 folding in the anchoring area, thereby minimizing any interference of the folds of the sleeve 1826 with the anchors 32.

[0319] Further note that even if the sleeve 1826 is stretched at the second segment 1824, the elastic force of the second segment 1824 (i.e., the force exerted by the sleeve 1826 to return to its original length after the segment 1824 is anchored) can be selected and / or configured to be of insufficient strength to cause the annulus to contract. Thus, annuloplasty is achieved only when the physician deliberately contracts the sleeve 1826 (e.g., using the contraction member 30). That is, the elastic force of the second segment 1824 is not strong enough to cause the second segment 1824 to contract enough to affect the tissue 10 to which the second segment 1824 is coupled.

[0320] Referring again to Figure 18A -C. The system 1800 minimizes the likelihood of any excess sleeve 1826 interfering with the heart valve. As Figure 18B shown, after the first segment 1822 has been anchored, the second segment 1824 expands by being stretched and subsequently, the second segment 1824 is anchored to the heart tissue using the anchor 32. Additionally, with the system 1800, the physician does not need to measure the size of the annulus before positioning the annuloplasty structure 1820. In this way, the structure 1820 accommodates and adapts to all native annulus sizes.

[0321] After the physician has positioned the structure 1820 along the annulus and has expanded the segment 1824, the annuloplasty structure 1820 is contracted using the contraction member 30. For some applications, the contraction member 30 is coupled to an actuatable contraction mechanism as described in U.S. Patent Application Publication 2014 / 0309661 to Sheps et al. and / or U.S. Patent Application Publication 2015 / 0272734 to Sheps et al. (which are incorporated herein by reference). Additionally, any method described in the '661 and / or '734 applications can be used to complete the implantation of the structure 1820.

[0322] Figure 19 is a schematic diagram of an exemplary system 1900 according to some applications. The system 1900 includes a structure 1922 (e.g., an annuloplasty structure, an annuloplasty ring structure, etc.), the structure 1922 having a body portion 1912 (e.g., an annuloplasty body portion, an annuloplasty ring body portion, etc.), the body portion 1912 including a sleeve 1926 and a contraction member 30. For some applications, the sleeve 1926 is tapered. The sleeve 1926 is shaped and configured to define a lumen therethrough. For some applications, the body portion 1912 is flexible.

[0323] Structure 1922 includes one or more (e.g., two, shown by way of example and not limitation) telescoping segments 1930a and 1930b. Note that structure 1922 may include any number of telescoping segments 1930 of any length, as determined by the physician. For example, for some applications, all segments 1930 may have the same length. For other applications, segments 1930 may have variable lengths. Structure 1922 may be delivered to the heart in a configuration where telescoping segment 1930b is at least partially disposed within the lumen of telescoping segment 1930a, and telescoping segment 1930a is at least partially disposed within the lumen of sleeve 1926. Telescoping segments 1930a and 1930b may be movable or slidable along the longitudinal axis 21 of body portion 1912.

[0324] The proximal end of sleeve 1926 includes a coupling element 1934 that is configured to engage and couple to a coupling element 1932 at the distal end of telescoping segment 1930a. The proximal end of telescoping segment 1930a includes a coupling element 1934 that is configured to engage and couple to a coupling element 1932 at the distal end of telescoping segment 1930b. For some applications, coupling elements 1932 and 1934 include hook-and-loop fasteners. For some applications, coupling elements 1932 and 1934 include magnets. Coupling elements 1932 and 1934 may include annular coupling elements that provide an unobstructed passage through the lumen of the entire structure 1922. Coupling elements 1932 and 1934 are generally coupled together after telescoping segment 1930 has moved to its final position.

[0325] For some applications, telescoping segment 1930 includes the same material as sleeve 1926. For some applications, telescoping segment 1930 includes a material different from the material of sleeve 1826. For some applications, the wall thickness of telescoping segment 1930 may be less than the wall thickness of sleeve 1826.

[0326] The annuloplasty structure 1922 may include any annuloplasty structure or annuloplasty ring structure described herein with reference to Figures 1-18C In addition, for some applications, structure 1922 may include an actuatable constriction mechanism that includes and / or is coupled to a constriction member 30, as described in U.S. Patent Application Publication 2014 / 0309661 to Sheps et al. and / or U.S. Patent Application Publication 2015 / 0272734 to Sheps et al. (which are incorporated herein by reference).

[0327] The sleeve 1926 and the telescoping segment 1930 may include a braided fabric mesh, for example, including polyethylene terephthalate, Dacron(TM), other materials, etc. The sleeve 1926 and the telescoping segment 1930 may be configured to be disposed only partially around the heart valve annulus (i.e., in a C-shape), and after being anchored in place, be contracted to circumferentially tighten the annulus. Optionally, the ring structure may be configured to be disposed completely around the annulus (e.g., a full ring or a closed ring). To tighten the annulus, the system includes an actuatable adjustment mechanism or a contraction mechanism. The adjustment mechanism or the contraction mechanism may be part of one or more of the annuloplasty structure 1922, the flexible elongate contraction member 30 extending along the sleeve 1926 and the telescoping segment 1930, and / or other components, and / or be coupled to one or more of the annuloplasty structure 1922, the flexible elongate contraction member 30 extending along the sleeve 1926 and the telescoping segment 1930, and / or other components. The elongate contraction member 30 may include a wire, a strip, a cord, or a tape, which may include a flexible and / or superelastic material, such as nitinol, polyester, stainless steel, or cobalt chrome. For some applications, the contraction member 30 includes a radiopaque material. For some applications, the contraction member 30 includes a braided polyester suture (e.g., Ticron). For some applications, the contraction member 30 is coated, such as coated with polytetrafluoroethylene (PTFE) or other polymers. For some applications, the contraction member 30 includes multiple wires intertwined to form a cord structure. The actuatable adjustment mechanism or the contraction mechanism may be configured in various ways, such as any way described in other parts of this document regarding other actuatable adjustment mechanisms and / or described in other documents incorporated by reference.

[0328] For some applications, the sleeve 1926 and the telescoping segment 1930 are marked with one or more radiopaque markers. Generally, the sleeve 1926 and the telescoping segment 1930 include a flexible sleeve 1926 that is shaped and configured to define a lumen therethrough.

[0329] The anchor delivery system 1940 or other attachment system may be used to anchor or attach the first segment 1914 of the annuloplasty body portion 1912 of the annuloplasty structure 1922, for example, by deploying one or more tissue anchors 32 through the sleeve 1926 from within the lumen of the sleeve 1926 into the annulus tissue 10. The technique for deploying the anchors 32 through the sleeve 1926 may be practiced in combination with the technique described in Sheps' WO 2013 / 069019, which is incorporated herein by reference.

[0330] As shown, the body portion 1912 includes (1) a first section 1914, and (2) a second section 1916, which second section 1916 includes a telescoping section 1930. For some applications, the anchor delivery system 1940 can reversibly engage and reversibly grasp a portion of the telescoping section 1930 during pulling and moving the telescoping section 1930.

[0331] Any number of tissue anchors 32 or other fastening or attachment devices can be used to anchor or attach the structure 1922 to the annulus of the valve. In some embodiments, after a sufficient amount of the first section 1914 of the body portion 1912 is anchored / attached to the annulus, the physician uses the system 1940 to pull the telescoping section 1930a out of the lumen of the sleeve 1926 and expand it. After pulling the telescoping section 1930a out of the lumen of the sleeve 1926, it is anchored / attached to the annulus tissue 10 using the attachment device / tissue anchor 32, as shown. The physician then uses the system 1940 to pull the telescoping section 1930b out of the lumen of the telescoping section 1930a and expand it. After pulling the telescoping section 1930b out of the lumen of the telescoping section 1930a, it can be anchored / attached to the annulus tissue 10 using the attachment device / tissue anchor 32, as shown. In this way, the system 1900 minimizes the likelihood of any excess sleeve 1926 interfering with the heart valve. Additionally, using the system 1900, the physician does not need to measure the size of the annulus before positioning the annuloplasty ring structure 1922. In this way, the structure 1922 adapts to and fits all natural annulus sizes.

[0332] The first section 1914 can be designated for implantation near the anterolateral commissure and approximately between P2, while the second section 1916 can be designated for implantation between approximately P2 and the posterolateral commissure. The telescoping section 1930 can be positioned at any part of the body portion 1912.

[0333] After the physician has positioned the structure 1922 along the annulus and has secured the telescoping section 1930, the annuloplasty structure 1922 is contracted using the contraction member 30. For some applications, the contraction member 30 is coupled to an actuatable contraction mechanism as described in U.S. Patent Application Publication 2014 / 0309661 to Sheps et al. and / or U.S. Patent Application Publication 2015 / 0272734 to Sheps et al. (which are incorporated herein by reference). Additionally, any of the methods described in the '661 and / or '734 applications can be used to complete the implantation of the structure 1820.

[0334] Reference Figure 20 、 21A-B, 22A-C, and 23, which are schematic diagrams of an annuloplasty system 2000 and its application according to some applications. The system 2000 includes an elongate annuloplasty structure 2020 having a flexible body portion 2023 (e.g., an annuloplasty body portion, an annuloplasty ring body portion, etc.). The annuloplasty structure 2020 may include any annuloplasty structure or annuloplasty ring structure described herein. Generally, the annuloplasty structure 2020 includes a constriction member 30 for constricting the body portion 2023 after implantation of the annuloplasty structure. The constriction member 30 extends along the body portion 2023. Additionally, for some applications, the system may include an actuatable adjustment mechanism 2040. The adjustment mechanism may be part of one or more of the structure 2020, the constriction member 30, and / or other components, and / or coupled to one or more of the structure 2020, the constriction member 30, and / or other components, e.g., as described elsewhere herein and / or as described in U.S. Patent Application Publication 2014 / 0309661 to Sheps et al. and / or U.S. Patent Application Publication 2015 / 0272734 to Sheps et al. (which are incorporated herein by reference). Optionally, the structure 2020 (and other annuloplasty structures described herein) may be constricted by: tensioning the constriction member 30 by pulling on the constriction member, and locking the tensioning using a locking element such as a crimp. The implantation of the structure 2020 may be accomplished using any method described in the '661 and / or '734 applications.

[0335] The annuloplasty structure 2020 (e.g., the body portion 2023) includes a tubular wall 2025 that defines a lumen along the body portion 2023. That is, the lumen is defined along the longitudinal axis of the elongate annuloplasty structure 2020. The wall 2025 includes a sleeve 2026 and a helical member 2028. The sleeve 2026 may include a woven fabric mesh, e.g., including polyethylene terephthalate, Dacron(TM), other materials, etc. The body portion 2023 (e.g., the wall 2025, such as the sleeve 2026) may be configured to be disposed only partially around the cardiac annulus (i.e., in a C-shape), and after being anchored in place, constricted to circumferentially tighten the annulus. Optionally, the body portion may be configured to be disposed completely around the annulus (e.g., a full ring or a closed ring). For some applications, the body portion 2023 (e.g., the sleeve 2026) is marked with one or more radiopaque markers, e.g., as described above, with necessary modifications.

[0336] The helical member 2028 defines a plurality of turns that extend in a helical path along and around a lumen of the body portion 2023. The helical member 2028 is coupled to the sleeve 2026. For example, the helical member 2028 (e.g., a portion thereof, or the whole) may be sutured or glued to the sleeve 2026. Structure 2020 shows the helical member 2028 disposed on the inner side of the sleeve 2026, but the helical member may optionally be disposed on the outer side of the sleeve. For some applications, the helical member may be embedded within the sleeve.

[0337] A variety of other annuloplasty structures described herein are described as being capable of being anchored to tissue by an anchor 32 that is driven through the sleeve and into the tissue. Thus, in some applications, such a sleeve is configured to be strong enough to support the forces generated at the anchor point (e.g., at the point where the anchor pierces the sleeve). As described above (e.g., with reference to Figure 10 ), there is typically a trade-off between (i) the strength, stiffness, and / or stability of the sleeve and (ii) the compressibility and / or stretchability of the sleeve. To provide increased longitudinal compressibility of the body portion 2023 (e.g., to accommodate various annulus sizes), the sleeve 2026 is made of a particularly flexible, compressible, and / or stretchable (e.g., elastically stretchable) material (e.g., fabric). Thus, this material may be thinner, less dense, and / or weaker than the materials of other sleeves described herein. To accommodate this, the body portion 2023 includes a helical member 2028 that is stronger (sturdier, strong) and generally stiffer than the sleeve 2026. The annuloplasty structure 2020 is anchored to tissue by an anchor 32 that holds the helical member 2028 to the tissue, generally by being driven through the helical member ( Figure 21A -B). The helical member 2028 thus provides the strength required to anchor the annuloplasty structure 2020 and perform annuloplasty by contracting the annuloplasty structure while the sleeve 2026 continues to perform the other functions performed by other sleeves described herein (such as providing a closed lumen that reduces the likelihood of the anchor becoming an embolus).

[0338] For some applications, the helical member 2028 includes a polymer. For some applications, the helical member 2028 is metallic. For some applications, the helical member 2028 includes a shape memory material. For some applications, the helical member 2028 includes fabric.

[0339] The helical member 2028 allows the implanted annuloplasty structure 2020 to be relatively compressed for a relatively small annulus, where the helical member has a relatively small pitch ( Figure 22A ), or relatively stretched for a relatively large annulus, where the helical member has a relatively small pitch ( Figure 22B). In addition, if it is determined during the implantation process that the annulus is larger or smaller than initially perceived, the operating physician can dynamically adjust the degree of compression / stretching of the subsequently anchored portion of the main body portion 2023. Figure 22C An example of such dynamic adjustment is shown where, after seven anchors 38 have been anchored, it is determined that the annulus is larger than initially anticipated, and the operating physician dynamically increases the degree of stretch of subsequent anchors.

[0340] For some other annuloplasty structures described herein, the contraction member 30 extends along the main body portion of the annuloplasty structure by being woven along a sleeve of the annuloplasty structure. In contrast, due to the specific nature of the sleeve 2026, for the annuloplasty structure 2020, the contraction member 30 extends through the lumen of the main body portion 2023, i.e., radially inward from the helical member 2028.

[0341] Figure 21A -B shows the implantation steps of the annuloplasty structure 2020 according to some applications. An attachment device, such as a plurality of anchors 38, can be used. In some embodiments, each anchor 38 includes a head 34 and a tissue engaging element 36. The tissue engaging element 36 is shown as a helical tissue engaging element that is screwed into the tissue, but can be any suitable type of tissue engaging element, including a dart or a U-shaped staple. Each anchor 32 is sized to be advanceable along (i.e., longitudinally through) a cavity of the main body portion 2023, typically with the tissue engaging element 36 disposed distally of the head 34. The anchor driver 2052 can be reversibly coupled to the anchor 32 (e.g., its head 34) and is configured to advance the anchor along the cavity (typically introducing the anchor into the cavity via the open proximal end of the cavity). In some embodiments, anchor driver 2052 secures a corresponding helical turn of helical member 2028 to tissue using each anchor by driving tissue engaging element 36 from lumen through wall 2025 and into tissue such that the helical turn is clamped between head 34 and tissue. Figure 21A -B, the tissue engaging element 36 can be driven through the helical member 2028 itself.

[0342] For some applications, and such Figure 23 As shown in FIG. , the tissue engaging element 36 or at least some (or all) of the tissue engaging elements can be driven through the wall 2025 at a location adjacent to the helical turn to be anchored (e.g., between the helical turns), but close enough to the helical turn so that the helical turn is clamped between the head 34 and the tissue. Figure 23 Adjacent helical turns are shown anchored by a single anchor 32 disposed between the adjacent helical turns.For some such applications, the head 34 is wider than the application where the tissue engaging elements 36 are driven through the helical member itself.

[0343] For some applications, each turn of the helical member 2028 is fixed to tissue by a corresponding anchor 32 (e.g., as shown in Figure 22A -C). For some applications, not every turn is fixed by a corresponding anchor. For example, Figure 21B shows an unfixed turn disposed between two fixed turns.

[0344] After it is anchored to the annulus, the annuloplasty structure 2020 is constricted to reduce the size of the annulus, e.g., as described above, with necessary modifications. The helical member 2028 and the sleeve 2026 also facilitate this, where the pitch of the helical member decreases during constriction.

[0345] For some applications, and as shown, the system 2000 includes a tool 2012 that facilitates the delivery and / or anchoring of the annuloplasty structure 2020. For some applications, the anchor driver 2052 is a component of the tool 2012. For some applications, the tool 2012 includes an anchor channel 2018 that extends into (and generally through) the lumen of the body portion 2023. For such applications, the annuloplasty structure 2020 is typically delivered with the channel 2018 already in place. Each anchor 32 is advanced into and through the lumen of the body portion 2023 by being advanced through the channel 2018. The anchor is typically anchored by pushing it out of the distal opening of the channel and through a portion of the wall 2025 directly in front of the distal opening. After each portion of the body portion 2023 is anchored, a subsequent portion of the body portion is advanced away from the channel 2018 (e.g., by retracting the channel 2018 relative to the body portion), and then the subsequent portion is anchored.

[0346] Control of this advancement can be facilitated by the mating between the channel 2018 and the helical portion 2023. For example, when the channel 2018 is moved to the next tissue site where the annuloplasty structure 2020 is to be anchored, the tension generated on the body portion 2023 can cause the helical member 2028 to tighten around the channel, thereby gripping the channel and increasing control over the advancement of the body portion away from the channel. For some applications, the tool 2012 includes a projection 2016 that extends radially outward from the channel 2018 and engages the helical member 2028, inhibiting the turns engaged therewith from slipping away from the channel ( Figure 21A-B). The advancement of the body portion 2023 out of the channel 2018 can thus be controlled by the rotation of the protrusion 2016 about the central longitudinal axis of the channel. For applications in which the protrusion 2016 is rigidly fixed to the channel 2018, this rotation is achieved by rotating the channel 2018 about its longitudinal axis. Generally, one complete rotation of the protrusion 2016 (e.g., by one complete rotation of the channel 2018), optionally in combination with proximal retraction of the channel 2018, allows one complete turn of the helical member 2028 (and the associated portion of the body portion 2023) to be advanced out of the channel 2018.

[0347] For some applications, the protrusion 2016 is movable relative to the channel 2018, thereby providing a further degree of adjustability and / or control over the advancement of the body portion 2023 out of the channel. For example, and as Figures 21A-21B shown, the protrusion 2016 can be longitudinally slidable relative to the channel 2018. Optionally or additionally, the protrusion 2016 can be circumferentially rotatable about the channel 2018 independent of the rotation of the channel itself.

[0348] Now refer to Figures 1-23 . Components of any system and / or device shown or described herein can be combined with any other device or embodiment shown or described herein. For example, Figure 9 the fabric shown in Figure 8A -B can be used in combination with the structure 522 shown in

[0349] Again refer to Figures 1-23 . Systems 20, 120, 220, 250, 320, 420, 620, 720, 820, 920, 1000, 1600, 1700, 1800, 1900, and 2000 for repairing a dilated valve annulus of a patient, as well as methods 1200 and 1300, can be used to treat any heart valve of a patient, such as the aortic valve, pulmonary valve, mitral valve, and tricuspid valve. In addition, the methods, operations, steps, etc. described herein can be performed on live animals or non-living cadavers, cadaver hearts, simulators, anthropomorphic phantoms, etc. The systems for valve treatment described herein can be used to treat other circular muscles within a patient's body. For example, the systems described herein can be used to treat the sphincter within a patient's stomach.

[0350] Again refer to Figures 1-23。Further note that the systems 20, 120, 220, 250, 320, 420, 620, 720, 820, 920, 1000, 1600, 1700, 1800, 1900, and 2000 can be anchored or attached to tissue (e.g., tissue of the annulus) using any anchoring device and / or attachment device described in U.S. Patent Application Publication 2015 / 0272734 to Sheps et al. (including an anchor driver and a deployment manipulator) or otherwise described herein.

[0351] Referring again to Figures 1-23 。The systems 20, 120, 220, 250, 320, 420, 620, 720, 820, 920, 1000, 1600, 1700, 1800, 1900, and 2000 and the methods 1200 and 1300 (or sub-components thereof) and the methods described above can also be applied to any suitable tissue of a patient (e.g., gastric tissue, urinary tract, and prostate tissue).

[0352] Additionally, the scope of this disclosure includes applications described in one or more of the following:

[0353] ·U.S. Patent Application 12 / 435,291 to Maisano et al., titled "Adjustable repair chords and

[0354] spool mechanism therefor", filed May 4, 2009, and issued as U.S. Patent 8,147,542

[0355] authorized;

[0356] ·U.S. Patent Application 12 / 437,103 to Zipory et al., titled "Annuloplasty ring with intra-ring

[0357] anchoring", filed May 7, 2009, and issued as U.S. Patent 8,715,342 authorized;

[0358] ·U.S. Patent Application 12 / 548,991 to Maisano et al., titled “Implantation of repair chords in

[0359] the heart”, filed Aug. 27, 2009, and issued as U.S. Patent 8,808,368 authorized;

[0360] ·PCT Patent Application PCT / IL2009 / 001209 to Cabiri et al., titled “Adjustable annuloplasty

[0361] devices and mechanisms therefor”, filed on December 22, 2009, and published as PCT Publication

[0362] WO 10 / 073246;

[0363] ·PCT Patent Application PCT / IL2010 / 000357 by Maisano et al., entitled "Implantation of repair

[0364] chords in the heart", filed on May 4, 2010, and published as WO 10 / 128502;

[0365] ·PCT Patent Application PCT / IL2010 / 000358 by Zipory et al., entitled "Deployment techniques

[0366] for annuloplasty ring and over - wire rotation tool", filed on May 4, 2010, and published as

[0367] WO 10 / 128503;

[0368] ·U.S. Patent Application Publication 2014 / 0309661 by Sheps et al.; and / or

[0369] ·U.S. Patent Application Publication 2015 / 0272734 by Sheps et al.

[0370] All of these applications are hereby incorporated by reference. The techniques described herein can be practiced in conjunction with the techniques described in one or more of these applications.

[0371] Those skilled in the art will recognize that the invention is not limited to what has been specifically shown and described above. Rather, the scope of the invention includes combinations and sub - combinations of the various features and steps described above, as well as variations and modifications thereof that are non - prior art and would occur to those skilled in the art upon reading the foregoing description.

Claims

1. An apparatus, comprising: An annuloplasty structure having a longitudinal axis, the annuloplasty structure comprising: A main body portion; One or more connecting segments removably coupled to the main body portion; A first coupling member coupled to a first end of the main body portion; A second coupling member coupled to a first end of a first connecting segment of the one or more connecting segments, the first connecting segment being disposed adjacent to the first coupling member at the first end of the main body portion, the first coupling member and the second coupling member being shaped to mate with each other; and An anti-disconnection element longitudinally extending along at least the first coupling member and the second coupling member to prevent disconnection of the first coupling member and the second coupling member, wherein removal of the anti-disconnection element from at least the first coupling member and the second coupling member facilitates disconnection of the first coupling member and the second coupling member.

2. The apparatus according to claim 1, wherein at least one of the main body portion and the one or more connecting segments is flexible.

3. The apparatus according to any one of claims 1 - 2, further comprising an elongate retractable member extending along the longitudinal length of the main body portion and along the one or more connecting segments.

4. The apparatus according to any one of claims 1 - 2, wherein the anti - detachment element comprises an elongate retractable member extending along the longitudinal length of the main body portion and the one or more connecting segments.

5. The apparatus according to any one of claims 1 - 4, further comprising a retraction mechanism coupled to the annuloplasty structure and configured to cause at least a portion of the annuloplasty structure to contract.

6. The apparatus according to any one of claims 1 - 5, wherein: The first coupling member is shaped to define a first cavity and includes one or more radially movable protrusions that are radially movable in response to a force applied thereto, and The second coupling member is shaped to define a second cavity and a negative space, the negative space being shaped to receive the one or more radially movable protrusions.

7. The apparatus according to any one of claims 1 - 5, wherein: The first coupling member is shaped to define a first cavity and includes one or more radially movable protrusions that are biased to radially collapse inwardly in the absence of a force applied thereto; The second coupling member is shaped to define a second cavity and a negative space, the negative space being shaped to receive one or more radially movable protrusions; and The anti-disconnection element includes an elongate tube configured to maintain the one or more radially movable protrusions within the negative space of the second coupling member to prevent disconnection of the first coupling member and the second coupling member when a portion of the elongate tube passes through corresponding first and second cavities of the first coupling member and the second coupling member.

8. The apparatus according to claim 7, wherein the elongate tube forms part of an anchor delivery system, and wherein the anchor delivery system is configured to deploy tissue anchors through the one or more connecting segments.

9. The apparatus according to claim 7, wherein: The one or more connecting segments include at least the first connecting segment and at least a second connecting segment, The first connecting segment includes a third coupling member coupled to a second end of the first connecting segment, The second connecting segment includes a fourth coupling member coupled to a first end of the second connecting segment, the second connecting segment being disposed adjacent to the first connecting segment, the fourth coupling member being shaped to mate with the third coupling member, The anti-disconnection element longitudinally extends at least through the third coupling member and the fourth coupling member to prevent disconnection of the third coupling member and the fourth coupling member, and Removal of the anti-disconnection element from at least the third coupling member and the fourth coupling member facilitates disconnection of the third coupling member and the fourth coupling member.

10. An apparatus, comprising: An annuloplasty structure, the annuloplasty structure comprising: A body portion shaped to define: A plurality of compressible segments, each of the plurality of compressible segments having a first thickness; and A plurality of anchor - specifying sections, each of the plurality of anchor - specifying sections having a second thickness that is greater than the first thickness of the corresponding one of the plurality of compressible sections, the plurality of anchor - specifying sections being arranged alternately with the plurality of compressible sections, and each anchor - specifying section being designated for delivering a corresponding tissue anchor therethrough; and A shrinkage member coupled to the body portion, the shrinkage member being configured to shrink the body portion, and the plurality of compressible sections facilitating a reduction in the total compressive force on the body portion during shrinking of the body portion by the shrinkage member.

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