Implantable annuloplasty structure adapted to various valve ring sizes

Abstract

An annuloplasty structure (122) includes a main body portion (123) and a contraction member (30). The main body portion may include a flexible material and may be shaped to define one or more controllably expandable segments (40). Each controllably expandable segment has a corresponding first length (L1). Each controllably expandable segment may be expanded or contracted to present a corresponding second length (L2), the corresponding second length (L2) being different from the corresponding first length. The contraction member is coupled to the main body portion and is configured to contract the main body portion independently of a mechanism for expanding the controllably expandable segment. Other embodiments are also described.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Patent Application No. 62 / 676,145 filed May 24, 2018 by Peleg et al. and U.S. Provisional Patent Application No. 62 / 720,392 filed August 21, 2018 by Peleg et al. Each of the above applications is incorporated herein by reference. Technical Field

[0003] Some applications generally relate to valve repair, for example, repair of a patient's atrioventricular valve. Some applications relate to minimally invasive valve repair and / or transluminal valve repair. Background Art

[0004] Ischemic heart disease can cause mitral regurgitation through a combination of ischemic dysfunction of the papillary muscles and left ventricular enlargement present in ischemic heart disease with subsequent papillary muscle displacement and dilation of the mitral annulus.

[0005] Enlargement of the mitral annulus prevents the valve leaflets from fully coapting when the valve closes. 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 volume overload and pressure overload of the left atrium followed by eventual weakening of the left ventricle. Various problems can also occur with regurgitation at the tricuspid and other valves. Summary of the invention

[0006] This overview 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 overview section is not required by the claims unless the claims explicitly define the feature. In addition, the features, components, steps, concepts, etc. described in the examples in this overview section and 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 mitral valves or tricuspid valves). The various features and steps described in other parts of this disclosure may be included in the examples of this overview section. The methods, operations, steps, etc. described herein can be performed on living animals or non-living corpses, corpse hearts, simulators (e.g., with simulated body parts, tissues, etc.), etc.

[0007] In some applications, a system or device is provided that includes an implant structure that includes an annuloplasty structure or annuloplasty ring structure configured to fit all or a plurality of different annular sizes. Various systems, devices, and methods are described that enable minimally invasive and / or transluminal (e.g., transcatheter, transvascular, etc.) positioning of an annuloplasty structure along the annulus without requiring prior measurement of the annular size. In this way, the systems and devices described herein can accommodate and fit all annular sizes of any patient or most annular sizes of most patients.

[0008] The implant structure may include at least a portion of an annuloplasty structure (e.g., an annuloplasty ring structure, a partial annuloplasty ring, a complete annuloplasty ring, annuloplasty band, etc.) for repairing an enlarged annulus of a patient's native atrioventricular valve (e.g., the mitral valve or tricuspid valve).

[0009] For certain applications, an elongated annuloplasty structure, such as described above, is transluminally positioned along the annulus and sequentially attached (e.g., anchored, fastened, clamped, attached, etc.) to the annulus. In such applications, the elongated annuloplasty structure may be longer than required for a given annulus, and thus, the elongated annuloplasty structure includes a device or feature that enables shortening of the overall length of the elongated annuloplasty structure while maintaining the body portion of the annuloplasty structure intact (e.g., by not cutting or severing any portion of the body portion). For certain 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 certain applications, the elongated annuloplasty structure is shortened (e.g., compressed) in conjunction with the anchoring process, for example, alternating between shortening and attachment.

[0010] 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 then attached (e.g., anchored, etc.) to the annulus. For some applications, expansion of the annuloplasty structure is performed in conjunction 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.

[0011] Therefore, a system or device including an annuloplasty structure is provided according to certain applications. The annuloplasty structure includes a main body portion (such as an annuloplasty ring main body portion, annuloplasty main body portion, etc.), which includes a flexible material. In some applications, the main 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 main body portion includes one or more control wires connected to the one or more controllable expansion segments, and the one or more control wires are movable to promote the expansion of each of the one or more controllable expansion segments, thereby presenting a corresponding second length, which is 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 connected to the contraction member. The contraction member is connected to the main body portion and is configured to contract the main body portion independently of the one or more control wires.

[0012] In some applications, each of the one or more controllably expandable sections constitutes a portion of the flexible material of the body portion, the portion being folded, and wherein the one or more control wires pass through the folded portion of the portion.

[0013] In some applications, the portion is telescopically folded in a direction away from a longitudinal axis of the main body portion at the portion.

[0014] In some applications, the portion is folded in such a way that at least one pocket is formed between the folded layers of the portion and has a longitudinal length measured along a pocket axis that is generally parallel to the main body longitudinal axis at the portion.

[0015] In some applications, the one or more control wires are removably coupled to the one or more controllable expansion segments, and the flexible material is biased such that the one or more controllable expansion segments expand after the one or more control wires are decoupled from the one or more controllable expansion segments.

[0016] In some applications, the one or more control wires are fixedly attached to the one or more controllable expansion segments, and the one or more control wires facilitate expansion of the one or more controllable expansion segments in response to pulling the one or more control wires.

[0017] In some applications, the one or more controllable expansion segments include a plurality of controllable expansion segments.

[0018] In some applications, the one or more control wires include exactly one control wire that controls all of the plurality of controllable expansion segments.

[0019] In some applications, the one or more control wires include a plurality of control wires, each of the plurality of control wires being movable to facilitate expansion of a corresponding one of the plurality of controllable expansion sections.

[0020] According to some applications, a method is further provided, including delivering an annuloplasty structure to the annulus of a patient's heart valve. The annuloplasty structure may be the same or similar to the annuloplasty structure described above or elsewhere herein. For example, in some applications, the annuloplasty structure includes a main body portion (e.g., an annuloplasty ring main body portion, etc.), the main body portion including a flexible material, the main 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 wires coupled to the one or more controllable expansion segments, the one or more control wires being movable to expand 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 annuloplasty structure includes a contraction member and / or a contraction mechanism or attachment mechanism comprising and / or coupled to the contraction member, the contraction member being coupled to the main body portion and configured to contract the main body portion independently of the one or more control wires. The method further includes controllably expanding the one or more controllably expandable sections by moving the one or more control wires.The method may be performed on a living animal or a non-living cadaver, a cadaver heart, a mimic, an anthropomorphic ghost, or the like.

[0021] In some applications, the one or more control wires are removably coupled to the one or more controllably expandable segments, the flexible material is biased so that the one or more controllably expandable segments expand upon removal of the one or more control wires, and controllably expanding includes detaching the one or more control wires from the one or more controllably expandable segments. In some applications, the one or more control wires are fixedly attached to the one or more controllably expandable segments, and controllably expanding includes pulling the one or more control wires.

[0022] In some applications, the one or more control wires include exactly one control wire that controls all of the plurality of controllably expandable segments, and controllably expanding the one or more controllably expandable segments includes controllably expanding the plurality of controllably expandable segments by incrementally moving exactly the one control wire.

[0023] According to some applications, a method is also provided, including delivering an annuloplasty structure to an annulus of a heart valve of a patient, the annuloplasty structure including a main body portion comprising a flexible material, the main body portion being shaped and / or configured to define a first controllably expandable segment and a second controllably expandable segment, each of the first controllably expandable segment and the second controllably expandable segment having a corresponding first length. The method includes: controllably expanding at least the first controllably expandable segment to a second length, the second length being greater than the first length; and securing the second controllably expandable segment to maintain the first length and prevent expansion of the second controllably expandable segment. This method can be performed on a living animal or a non-living corpse, a cadaver heart, a mimic, an anthropomorphic phantom, etc.

[0024] In some applications, securing the second controllably expandable section includes driving a tissue anchor through a material of the second controllably expandable section.

[0025] In some applications, the method further includes collapsing the body portion after securing the second controllably expandable section.

[0026] Each of the first controllably expandable section and the second controllably expandable section may include a corresponding portion of the flexible material of the body portion that is folded.

[0027] According to some applications, a method is further provided, comprising delivering an annuloplasty structure to an annulus of a heart valve of a patient, the annuloplasty structure comprising a main body portion. The main body portion may comprise a flexible material. In some embodiments, the method comprises: anchoring a first segment of the main body portion to tissue of the annulus using a first tissue anchor using an anchor delivery system. The method may further comprise: after anchoring, compressing a second segment of the main body portion toward the first segment of the main body portion using the anchor delivery system. The method may further comprise: after compression of the second segment, driving a second tissue anchor through the main body portion and into tissue of the annulus using the anchor delivery system, and maintaining compression of the second segment of the main body portion by driving the second tissue anchor. This method may be performed on a living animal or a non-living corpse, a cadaver heart, a mimic, an anthropomorphic phantom, or the like.

[0028] In some applications, compressing the second section of the body portion includes reversibly engaging the anchor delivery system with the second section.

[0029] 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.

[0030] In some applications, after maintaining compression of the second section, the body portion is collapsed using a collapse member of a flexible material coupled to the body portion.

[0031] According to some applications, systems and / or devices are also provided, which include an annuloplasty structure (e.g., an annuloplasty ring structure, etc.), which includes a main body portion (e.g., an annuloplasty ring main body portion, etc.). In some applications, the main body portion is shaped and / or configured to define a plurality of compressible sections, each of the plurality of compressible sections having a first thickness. The main body portion may also be shaped and / or configured to include a plurality of anchor designated sections, each of the plurality of anchor designated sections having a second thickness, the second thickness being greater than the first thickness of a corresponding one of the plurality of compressible sections. The plurality of anchor designated sections may be arranged alternately with the plurality of compressible sections, each anchor designated section being designated for delivering a corresponding tissue anchor therethrough. In some applications, a contraction member is coupled to the main body portion, the contraction member being configured to contract the main body portion. The plurality of compressible sections of flexible material may facilitate a reduction in the total compressive force on the flexible material of the main body portion during contraction of the main body portion by the contraction member.

[0032] 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 comprises fabric.

[0033] In some applications, each of the plurality of compressible sections is shaped and / or configured to define a window.

[0034] In some applications, the body portion includes at least one flexible material that defines the plurality of compressible sections and the plurality of anchor-designated sections.

[0035] In some applications, the body portion includes:

[0036] at least one first flexible material defining the plurality of compressible sections; and at least one second flexible material defining the plurality of anchor-designated sections.

[0037] In some applications, each of the plurality of compressible segments is shaped and / or configured to define a compressible segment wall, and wherein the compressible segment wall has a first thickness.

[0038] In some applications, each of the plurality of anchor designating sections is shaped and / or configured to define an anchor designating wall, and the anchor designating wall has a second thickness.

[0039] 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 or similar to the structures described above or elsewhere herein. For example, in some applications, the annuloplasty structure includes a main body portion (e.g., an annuloplasty ring main body portion, etc.) having first and second main body portion ends and including a flexible material. The flexible material of the main body portion can be shaped and / or configured to define an anchor coupling region or attachment region between the first main body portion end and a vicinity of the main body portion between the first and second main body portion ends (excluding the second main body portion end). In some applications, the flexible material of the main body portion is also shaped and / or configured to define a deformable region between the second main body portion end and a vicinity of the main body portion between the first and second main body portion ends (excluding the first main body portion end). The deformable region can be deformable in the absence of a force applied thereto, and can be deformable to shorten the overall length of the main body portion.

[0040] In some applications, the system and / or device further includes a retraction member coupled to the body portion, the retraction member being configured to retract at least the anchor coupling region or attachment region of the body portion.

[0041] In some applications, the deformable region can be deformed into a helical configuration in the absence of a force applied to the deformable region.

[0042] In some applications, the deformable region includes nitinol, and the nitinol is configured to facilitate deformation of the deformable region.

[0043] In some applications, the deformable region assumes a linear configuration when the tube is disposed at least through the lumen of the deformable region.

[0044] In some applications, the tube constitutes the anchor delivery system.

[0045] 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 heart valve of a patient. The annuloplasty structure can be the same or similar to other annuloplasty structures described above or elsewhere herein. For example, in some applications, the annuloplasty structure includes a main body portion (e.g., an annuloplasty ring main body portion, etc.) having first and second main body portion ends and including a flexible material. In some applications, the flexible material of the main body portion is shaped and / or configured to define an anchor coupling region or attachment region between the first main body portion end and a vicinity of the main body portion between the first and second main body portion ends (excluding the second main body portion end). In some applications, the flexible material of the main body portion is shaped and / or configured to define a deformable region between the second main body portion end and a vicinity of the main body portion between the first and second main body portion ends (excluding the first main body portion end). The deformable region can be deformable in the absence of a force applied thereto, and can be deformable to shorten the overall length of the main body portion. This method can be performed on living animals or non-living corpses, cadaver hearts, mimics, anthropomorphic phantoms, etc.

[0046] In some applications, the method further includes anchoring the anchor coupling region or attachment region to the annulus when the deformable region assumes the first shape. The method may include, after anchoring, allowing the deformable region to deform and assume the second shape in the absence of a force applied thereto.

[0047] In some applications, the method further includes shrinking the body portion after allowing the deformable region to deform.

[0048] 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 or similar to other annuloplasty structures described above or elsewhere herein. For example, the annuloplasty structure can include a body portion (e.g., an annuloplasty ring body portion, etc.) that includes a flexible material that includes a plurality of interwoven fibers. The body portion has a longitudinal axis.

[0049] In some applications, the body portion has at least a first longitudinal section that includes a first portion of the plurality of interwoven 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 interwoven fibers oriented at an angle of 110-160 degrees relative to the longitudinal axis of the body portion.

[0050] In some applications, the body portion has at least a second longitudinal section adjacent to the first longitudinal section, the second longitudinal section comprising:

[0051] A third portion of the plurality of interwoven fibers is oriented at an angle of 0-15 degrees relative to the longitudinal axis of the body portion.

[0052] A fourth portion of the plurality of interwoven fibers is oriented at an angle of 75-90 degrees relative to the longitudinal axis of the body portion.

[0053] In some applications, the compressibility of the first longitudinal section is greater than the compressibility of the second longitudinal section.

[0054] In some applications, the system and / or device further includes at least one tissue anchor, and the second longitudinal segment is designated for coupling the at least one tissue anchor thereto.

[0055] According to some applications, a method is further provided, comprising delivering an annuloplasty structure (e.g., an annuloplasty ring structure, etc.) to an annulus of a heart valve of a patient, the annuloplasty structure comprising a main body portion having a first end and a second end opposite each other. In some applications, the maximum cross-sectional measurement of the first end is greater than the maximum cross-sectional measurement of the second end. The method comprises attaching (e.g., anchoring, etc.) the annuloplasty structure to the annulus. After attachment, the method may comprise folding the second end toward the first end. This method may be performed on a living animal or a non-living corpse, a cadaveric heart, a simulator (e.g., where the annulus is a simulated annulus, etc.), an anthropomorphic phantom, etc.

[0056] In some applications, the body portion is shaped and / or configured to define a cavity, and folding the second end portion includes pushing the second end portion into the cavity toward the first end portion.

[0057] In some applications, the maximum cross-sectional measurement of the first end is 4 to 6 mm.

[0058] In some applications, the maximum cross-sectional measurement of the second end is 3.0 to 3.9 mm.

[0059] According to some applications, a method is also provided, including delivering an annuloplasty structure (e.g., an annuloplasty ring structure, etc.) to an annulus of a heart valve of a patient. The annuloplasty structure may 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.), which may 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 contract the body portion. In some applications, the method further includes: after delivery, shortening at least a portion of the body portion to a second longitudinal length shorter than the first longitudinal length independent of the contraction member while maintaining the overall integrity of the body portion; and after shortening, reshaping the annulus by contracting the body portion 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 corpse, a cadaver heart, a mimic, an anthropomorphic phantom, etc.

[0060] In some applications, shortening the portion of the main body portion includes shortening the portion of the main body portion prior to anchoring. In some applications, shortening the portion of the main body portion includes: shortening the portion of the main body portion progressively with anchoring by anchoring the first segment of the main body portion to the annulus using an anchor delivery system by driving the anchor through the first segment of the main body portion, and then compressing the second segment of the main body portion toward the first segment of the main body portion using the anchor delivery system.

[0061] In some applications, shortening the portion of the body portion includes shortening the portion of the body portion after anchoring.

[0062] In some applications, shortening the portion of the body portion after anchoring includes causing a deformable region of the body portion to assume a deformed shape.

[0063] In some applications, shortening the portion of the body portion includes folding the second end of the body portion toward the first end of the body portion.

[0064] 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.

[0065] According to some applications, systems and / or devices are also provided that include an annuloplasty structure (eg, an annuloplasty ring structure, etc.). The annuloplasty structure includes a body portion (eg, an annuloplasty ring body portion, etc.). The body portion may include a first flexible material.

[0066] 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 anchor designation sections of the body portion or in the flexible material of the body portion. The plurality of anchor designation sections may be arranged alternately with the plurality of windows, each anchor designation section being designated for delivery of a corresponding tissue anchor therethrough.

[0067] The system / device 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. The system / device may further include a contraction member coupled to the main body portion and the plurality of covers, the contraction member being configured to contract the main body portion, the plurality of windows in the flexible material promoting a reduction in the total compressive force on the flexible material of the main body portion along the main body portion during contraction of the main body portion by the contraction member.

[0068] In some applications, each of the plurality of windows is shaped and / or configured to define a longest dimension of 12-16 mm.

[0069] In some applications, the first flexible material has a first thickness, and wherein the second flexible member has a second thickness, the first thickness being greater than the second thickness.

[0070] In some applications, the first thickness is 0.05-0.1 mm. In some applications, the second thickness is 0.15-0.2 mm.

[0071] In some applications, the second flexible material includes:

[0072] a first portion of the plurality of interwoven fibers oriented at an angle of 20-70 degrees relative to a longitudinal axis of the body portion; and

[0073] A second portion of the plurality of interwoven fibers is oriented at an angle of 110-160 degrees relative to the longitudinal axis of the main body portion.

[0074] In some applications, the first flexible material includes:

[0075] a third portion of the plurality of interwoven fibers oriented at an angle of 0-15 degrees relative to the longitudinal axis of the body portion; and

[0076] A fourth portion of the plurality of interwoven fibers is oriented at an angle of 75-90 degrees relative to the longitudinal axis of the body portion.

[0077] According to some applications, a method is also provided, including delivering an annuloplasty structure (e.g., an annuloplasty ring, an annuloplasty ring structure, etc.) to an annulus of a heart valve of a patient, 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 anchor-designated sections of the flexible material, the plurality of anchor-designated sections being arranged alternately with the plurality of windows, each anchor-designated section being designated for delivering a corresponding tissue anchor 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, the plurality of windows in the flexible material facilitating 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 living animals or non-living corpses, cadaver hearts, mimics, anthropomorphic phantoms, etc.

[0078] According to some applications, systems and / or devices are also provided that 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 also includes one or more connecting segments removably coupled to the primary body portion.

[0079] In some embodiments, the annuloplasty structure further comprises: a first connector connected to the first end of the main body portion, and a second connector connected to the first end of a first connecting segment of the one or more connecting segments, the first connecting segment being arranged adjacent to the first connector at the first end of the main body portion, the first connector and the second connector being shaped and / or configured to cooperate with each other.

[0080] In some embodiments, the annuloplasty structure further comprises an anti-disconnection element extending longitudinally along at least the first and second couplings to prevent the first and second couplings from disconnecting. Removal of the anti-disconnection element from at least the first and second couplings can facilitate disconnection of the first and second couplings.

[0081] In some applications, the main body portion is flexible.In some applications, the one or more connecting segments are flexible.

[0082] In some applications, the system and / or device further includes an elongated constriction member extending along the longitudinal length of the main body portion and along the one or more connecting segments.

[0083] In some applications, the anti-decoupling element includes an elongated constriction member extending along the longitudinal length of the main body portion and the one or more connecting segments.

[0084] In some applications, the systems and / or devices further include a contraction mechanism coupled to the implant structure and configured to contract at least a portion of the implant structure.

[0085] In some applications:

[0086] The first coupling is shaped and / or configured to define a first cavity and includes one or more radially movable projections that are radially movable in response to a force applied thereto, and

[0087] The second coupling is shaped and / or configured to define a second cavity and a negative space shaped to receive the one or more radially movable protrusions.

[0088] In some applications:

[0089] the first coupling being shaped and / or configured to define a first cavity and comprising one or more radially movable projections biased to collapse radially inwardly in the absence of a force applied thereto;

[0090] The second coupling is shaped and / or configured to define a second cavity and a negative space shaped and / or configured to receive the one or more radially movable projections; and

[0091] The anti-disconnection element includes an elongated tube, which is configured to maintain the one or more radially movable protrusions in the negative space of the second connecting member when a portion of the elongated tube passes through the first and second cavities corresponding to the first connecting member and the second connecting member to prevent the first connecting member and the second connecting member from being disconnected.

[0092] In some applications, the elongated tube forms part of an anchor delivery system, and the anchor delivery system is configured to deploy the tissue anchor through the one or more connected segments.

[0093] In some applications:

[0094] The one or more connecting segments include at least a first connecting segment and at least a second connecting segment,

[0095] The first connecting segment includes a third connecting piece connected to the second end of the first connecting segment,

[0096] The second connecting segment includes a fourth coupling member coupled to a first end of the second connecting segment arranged adjacent to the first connecting segment, the fourth coupling member being shaped and / or configured to cooperate with the third coupling member,

[0097] The anti-disconnection element extends longitudinally through at least the third connecting piece and the fourth connecting piece to prevent the third connecting piece and the fourth connecting piece from being disconnected, and

[0098] Removal of the anti-decoupling element from at least the third coupling piece and the fourth coupling piece facilitates decoupling of the third coupling piece and the fourth coupling piece.

[0099] In some applications:

[0100] the third coupling being shaped and / or configured to define a third cavity and comprising one or more radially movable projections biased to collapse radially inwardly in the absence of a force applied thereto;

[0101] a fourth coupling shaped and / or configured to define a fourth cavity and a negative space shaped and / or configured to receive the one or more radially movable projections;

[0102] The extended tube of the anti-disconnection element is configured to maintain the one or more radially movable protrusions of the third connecting piece within the negative space of the fourth connecting piece when a portion of the extended tube passes through the third cavity and the fourth cavity corresponding to the third connecting piece and the fourth connecting piece, so as to prevent the third connecting piece and the fourth connecting piece from being disconnected.

[0103] In some applications, the elongated tube forms part of an anchor delivery system, and the anchor delivery system is configured to deploy the tissue anchor through the second connected segment.

[0104] According to some applications, a method is also provided, including delivering an annuloplasty structure (e.g., an annuloplasty ring structure, etc.) into 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 also includes one or more connecting segments removably connected to the main body portion. In some embodiments, the annuloplasty structure also includes a first coupling member connected to a first end of the main body portion and a second coupling member connected to a first end of a first connecting segment of the one or more connecting segments, the first connecting segment being arranged adjacent to the first coupling member at the first end of the main body portion. The first coupling member and the second coupling member may be shaped and / or configured to cooperate with each other. The annuloplasty structure may also include an anti-disconnection element extending longitudinally along at least the first coupling member and the second coupling member to prevent the first coupling member and the second coupling member from being disconnected. In some embodiments, the method further includes facilitating the 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 may be performed on a living animal or a non-living corpse, a cadaver heart, a mimic, an anthropomorphic phantom, etc.

[0105] In some applications, the method further comprises attaching (eg, anchoring, etc.) the main body portion to cardiac tissue prior to facilitating the decoupling. In some applications, the method further comprises shrinking at least the main body portion.

[0106] In some applications, facilitating decoupling of the first and second couplings includes applying a force to the one or more radially movable protrusions. In some applications, applying a force to the one or more radially movable protrusions includes applying a tensile force to the one or more connection segments.

[0107] In some applications, removing the anti-decoupling element includes moving the radially movable protrusion out of the negative space of the second coupling member.

[0108] According to some applications, systems and / or devices are also provided, which include an annuloplasty structure. The annuloplasty structure includes a main body portion. In some embodiments, the main 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 also include a contraction member coupled to the main body portion, the contraction member being configured to contract the main body portion, the main body portion promoting a reduction in the total compressive force on the flexible material of the main body portion during contraction of the main body portion by the contraction member.

[0109] In some applications, the second segment is arranged contiguously with the first segment. In some applications, the elasticity of the first segment is different from the elasticity of the second segment.

[0110] In some applications, the first segment is configured to be implanted at the annulus of a heart valve of the patient between the anterolateral commissure and P2, and the second segment is configured to be implanted between P2 and the posterolateral commissure.

[0111] In some applications, the first segment has a first, largest diameter, and the second segment has a second diameter that is smaller than the first diameter after the second segment is stretched.

[0112] According to some applications, a method is also provided, including delivering an annuloplasty structure to an annulus of a heart valve of a patient. 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. In some embodiments, the annuloplasty structure also includes a contraction member coupled to the body portion, the contraction member being configured to contract the body portion, the body portion promoting 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 also include securing the first segment to the annulus. The method may also include: after the first segment is secured, stretching the second segment; and subsequently, securing the second segment to the annulus. This method may be performed on a living animal or a non-living corpse, a cadaver heart, a simulator, a phantom, or the like.

[0113] In some applications, securing the first section includes driving a tissue anchor through material of the first section.

[0114] In some applications, securing the second section includes driving a tissue anchor through material of the second section.

[0115] In some applications, the method further includes collapsing the body portion after securing the second segment.

[0116] 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 smaller than the first diameter.

[0117] According to some applications, a method is further provided, including delivering an annuloplasty structure to an annulus of a heart valve of a patient, the annuloplasty structure including a body portion. The method may also include driving a first tissue anchor through the body portion of the annuloplasty structure. The method may also include positioning a first segment of the body portion along the annulus, the first segment of the body portion having a first length. In some embodiments, the method also includes securing the first segment 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 also include: exposing a second segment of the body portion, the second segment having a second length, the second length being less than the first length of the first segment of the body portion; and stretching the second segment of the body portion to a stretched state of the second segment. The stretched state of the second segment may have a third length, the third length being greater than the second length of the second segment before stretching. The method may also include: positioning the second segment of the body portion in the stretched state along the annulus; and securing the second segment of the body portion in the stretched state 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, a cadaver heart, a mimic (eg, where the annulus is a simulated annulus, etc.), an anthropomorphic phantom, etc.

[0118] In some applications, the method further includes releasing the first segment of the body portion from a delivery tool prior to positioning the first segment of the body portion along the annulus, and exposing the second segment of the body portion includes releasing the second segment of the body portion from a delivery system.

[0119] In some applications, the first segment has a first degree of stretchability and the second segment has a second degree of stretchability that is greater than the first degree of stretchability.

[0120] In some applications, the method further includes shrinking the body portion after the second section is secured.

[0121] According to some applications, there is further provided a system and / or device comprising an annuloplasty structure comprising a main body portion. In some embodiments, the main body portion is shaped and / or configured to define a first segment, and at least one telescopic second segment is configured to be at least partially disposed within the lumen of the first segment, the at least one telescopic second segment being movable proximally and distally along a longitudinal axis of the main body portion.

[0122] The annuloplasty structure may further include a contraction member coupled to the body portion, the contraction member being configured to contract the body portion, the body portion facilitating a reduction in an overall compressive force on the flexible material of the body portion during contraction of the body portion by the contraction member.

[0123] In some applications, the second segment is arranged adjacent to the first segment.In some applications, the first segment is configured to be implanted at the annulus of a heart valve of the patient between the anterior lateral commissure and P2, and the second segment is configured to be implanted between P2 and the posterolateral commissure.

[0124] In some applications, the at least one telescopic second segment includes at least a first telescopic segment and a second telescopic segment arranged adjacently, the second telescopic segment being configured to be at least partially arranged within a cavity of the first telescopic segment, and the second telescopic segment being movable proximally and distally along the longitudinal axis of the main body portion.

[0125] 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 couple together after the at least one telescoping second segment is moved relative to the first segment.

[0126] 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.

[0127] According to some applications, a method is also provided, including delivering an annuloplasty structure to an annulus of a heart valve of a patient. The annuloplasty structure includes a main body portion. The main body portion may be shaped and / or configured to define a first segment and at least one telescopic second segment. In some embodiments, the at least one telescopic second segment is configured to be at least partially disposed within a cavity of the first segment, and the at least one telescopic second segment is movable proximally and distally along a longitudinal axis of the main body portion. The annuloplasty structure may also include a contraction member coupled to the main body portion, the contraction member being configured to contract the main body portion, the main body portion promoting a reduction in the total compressive force on the flexible material of the main body portion during contraction of the main body portion by the contraction member. The method may 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 telescopic second segment along the longitudinal axis; and subsequently, fixing the at least one telescopic second segment to the annulus. This method may be performed on a living animal or a non-living corpse, a cadaver heart, a simulator (e.g., where the annulus is simulated, etc.), an anthropomorphic phantom, etc.

[0128] In some applications, securing the first section includes driving a tissue anchor through material of the first section.

[0129] In some applications, securing the at least one telescoping second section includes driving a tissue anchor through a material of the at least one telescoping second section.

[0130] In some applications, the method further includes retracting the body portion after the at least one telescoping second segment is secured.

[0131] In some applications, the first section includes a first coupling element and the at least one telescoping second section includes a second coupling element, and the method further includes coupling the first coupling element and the second coupling element together after moving the at least one telescoping second section.

[0132] 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.

[0133] According to some applications, there is further provided a system and / or device for cardiac tissue of a subject, the system and / or device comprising an elongated annuloplasty structure. The elongated annuloplasty structure may include a body portion (which may be flexible) including a wall. The wall may be a tubular wall defining a cavity along the body portion.

[0134] In some embodiments, the wall includes a sleeve and a helical member that is stiffer than the sleeve and coupled to the sleeve.The helical member can be configured to define a plurality of helical turns extending in a helical path along and around the lumen.

[0135] In some embodiments, the system and / or device comprises a plurality of anchors, each anchor comprising a head and a tissue engaging element. These may be sized to be advanceable along a lumen or cavities of the wall.

[0136] The system and / or device may include at least one anchor driver. The anchor driver may be configured to, for each anchor: reversibly couple the head; advance the anchor along the cavity; and / or secure corresponding helical turns to tissue with the anchor by driving the tissue engaging element of the anchor from the cavity through the wall and into the tissue such that the helical turns are clamped between the head and the tissue.

[0137] 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 to, for each anchor, utilize the anchor to secure the corresponding helical turn to the tissue - by driving the tissue engaging element of the anchor from the cavity through the helical member at the helical turn and into the tissue, so that the helical turn is clamped between the head and the tissue.

[0138] In some applications, at least one anchor driver is configured to, for each anchor, secure the corresponding helical turn to tissue using the anchor - by driving the tissue engaging element of the anchor from the cavity through the wall adjacent to the helical turn and into the tissue, so that the helical turn is clamped between the head and the tissue.

[0139] In some applications, the at least one anchor driver is configured to advance each anchor intracorporeally into and along the lumen.

[0140] In some applications, the sleeve is elastic.

[0141] In some applications, each anchor is sized to be advanceable through a lumen when the tissue engaging element of the anchor is disposed distally of the head of the anchor.

[0142] In some applications, the spiral member comprises a fabric. In some applications, the spiral member comprises a polymer. In some applications, the spiral member is metallic. In some applications, the spiral member comprises a shape memory material.

[0143] In some applications, the system and / or device further includes an elongated contraction member extending along and coupled to the body portion, the contraction member being configured to contract the body portion when tensioned.

[0144] In some applications, the constriction member extends radially inward from the helical member through the lumen.

[0145] In some applications, the system and / or device further includes an actuatable adjustment mechanism configured to contract the body portion by tensioning the contraction member upon actuation. In some embodiments, the actuatable adjustment mechanism is coupled to the body portion and to the contraction member.

[0146] In some applications, the system and / or device further includes a tool comprising 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.

[0147] In some applications, the anchor channel has a distal opening, and the anchor driver is configured to push the anchor out of the distal opening of the anchor channel and through a portion of the wall immediately in front of the distal opening.

[0148] In some applications, the tool is configured to deliver the annuloplasty structure transluminally to the heart when the anchor channel is positioned within the cavity.

[0149] In some applications, the tool is configured to incrementally advance the body portion out of the anchor channel.

[0150] In some applications, the tool includes a projection that extends radially outward from the anchor channel and engages the helical member to inhibit the body portion from slipping out of the channel.

[0151] In some applications, the tool is configured to facilitate controlled advancement of the body portion out of the anchor channel via rotation of the projection about a central longitudinal axis of the anchor channel.

[0152] In some applications, the projection is rigidly fixed to the anchor channel. In some applications, the projection is movable relative to the anchor channel. In some applications, the projection is longitudinally slidable relative to the anchor channel.

[0153] According to some applications, a method is further provided, comprising advancing an elongated annuloplasty structure into a subject through a cavity. The annuloplasty structure comprises a body portion (e.g., a flexible body portion) having a wall (e.g., a tubular wall, etc.). The wall may be a tubular wall defining a cavity along the body portion.

[0154] 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 can be configured to define a plurality of helical turns extending in a helical path along and around the cavity; and

[0155] The method includes securing the body portion to tissue of a subject. This may be accomplished by advancing a plurality of anchors along a cavity using at least one anchor driver, each anchor including a head and a tissue engaging element; and for each anchor, securing a corresponding helical turn to the tissue by driving the tissue engaging element of the anchor from the cavity through the wall and into the tissue such that the helical turn is sandwiched between the head and the tissue. The method may be performed on a living animal or a non-living cadaver, a cadaver heart, a mimic (e.g., where the tissue is simulated tissue, etc.), an anthropomorphic phantom, etc.

[0156] In some applications, fastening the corresponding helical turn with the anchor driver includes fastening the corresponding helical turn to the tissue with the anchor driver by driving the tissue engaging element of the anchor from the cavity through the helical member at the helical turn and into the tissue so that the helical turn is clamped between the head and the tissue.

[0157] In some applications, fastening the corresponding helical turn with an anchor driver includes fastening the corresponding helical turn to tissue with the anchor driver by driving a tissue engaging element of the anchor from a cavity through a wall adjacent to the helical turn and into the tissue such that the helical turn is clamped between the head and the tissue.

[0158] In some applications, the method further includes advancing each anchor in vivo into the cavity.

[0159] In some applications, advancing the plurality of anchors along the lumen with the anchor driver includes advancing the plurality of anchors along the lumen with the anchor driver while the tissue engaging elements of the anchors are disposed distally of the heads of the anchors.

[0160] In some applications, the annuloplasty structure further includes an elongated contraction member extending along and coupled to the body portion, and the method further includes contracting the body portion by tensioning the contraction member.

[0161] In some applications, the contraction member extends radially inward from the helical member through the lumen, and contracting the body portion by tensioning the contraction member includes contracting the body portion by tensioning the contraction member extending radially inward from the helical member through the lumen.

[0162] The various systems and / or devices described herein and elsewhere herein may further include an adjustment mechanism (e.g., such as on an annuloplasty structure, on a catheter, on another device, etc.), and contracting the body portion by tensioning the contraction member includes contracting the body portion by actuating the adjustment mechanism to tension the contraction member. In some embodiments, the adjustment mechanism is coupled to the body portion of the annuloplasty structure and / or to the contraction member. Furthermore, the methods herein may include contracting the body portion by tensioning the contraction member, including, for example, contracting the body portion by actuating the adjustment mechanism to tension the contraction member.

[0163] In some applications, advancing the plurality of anchors along the cavity with the anchor driver includes advancing the plurality of anchors through an anchor channel disposed in the cavity with the anchor driver. In some applications, securing the corresponding helical turns to the tissue with the anchor driver includes securing the corresponding helical turns to the tissue with the anchor driver by pushing the anchor out of a distal opening of the anchor channel and through a portion of a wall immediately in front of the distal opening.

[0164] In some applications, transluminally advancing the annuloplasty structure includes transluminally delivering the annuloplasty structure into the subject with the anchor channel disposed within the lumen.

[0165] In some applications, the method further includes advancing a portion of the body portion out of the anchor channel after securing each helical turn to the tissue.

[0166] In some applications, the anchor channel has a protrusion coupled thereto that extends radially outward from the anchor channel, and the method further includes controlling advancement of the body portion out of the anchor channel by rotating the protrusion about a central longitudinal axis of the anchor channel.

[0167] In some applications, rotating the protrusion about the central longitudinal axis of the anchor channel includes rotating the anchor channel about the central longitudinal axis of the anchor channel.

[0168] In some applications, controlling advancement of the body portion out of the anchor channel further comprises sliding the projection longitudinally relative to the anchor channel.

[0169] Other features and steps described in other parts of this document may also be used in conjunction with the above-mentioned systems, devices, apparatuses, methods, etc. A more complete understanding may be obtained through the following detailed description of the embodiments in conjunction with the accompanying drawings, in which: BRIEF DESCRIPTION OF THE DRAWINGS

[0170] Figure 1-5 and Fig. 6A -D is a schematic diagram of a corresponding example annuloplasty structure including a controllable expansion section;

[0171] Figure 7 is a schematic diagram of an example annuloplasty structure that may be shortened after the annuloplasty structure is anchored to annular tissue according to some applications.

[0172] Fig. 8A - B is a schematic diagram of an example annuloplasty structure including a deformable segment;

[0173] Figure 9-12 is a schematic diagram of a corresponding example annuloplasty structure including a corresponding fabric composition;

[0174] Fig.13A - C is a schematic diagram of an example system for compressing a portion of an annuloplasty structure;

[0175] Figure 14-15 This article is referenced Figure 1-13C corresponding flow charts of at least some example steps of the corresponding techniques described;

[0176] Fig.16 are schematic diagrams of example annuloplasty structures including different fabric compositions.

[0177] Fig.17A - F is a schematic diagram of an example annuloplasty structure including a removable connector;

[0178] Fig.18A -C is a schematic diagram of an example system including a variably stretchable annuloplasty ring structure;

[0179] Fig.19 is a schematic diagram of an example system including a telescopically expandable annuloplasty structure; and

[0180] Fig. 20 , 21A-B, 22A-C, and 23 are schematic diagrams of example annuloplasty systems including example elongated annuloplasty structures DETAILED DESCRIPTION

[0181] The following description and drawings, which describe and show certain embodiments, demonstrate in a non-limiting manner several possible configurations of systems, devices, apparatuses, methods, etc., that may be used for various aspects and features of the present disclosure. As an example, various systems, apparatuses / apparatuses, and methods are described herein, including systems, platforms, apparatuses, methods, etc., related to adjustable annuloplasty devices.

[0182] Figure 1 is a schematic diagram of a system 20 according to some applications, the system 20 including an implant including an annuloplasty structure 22 (e.g., an annuloplasty ring structure, annuloplasty band, partial annuloplasty ring, full annuloplasty ring, etc.), the annuloplasty structure 22 including a body portion 23 (e.g., an annuloplasty ring body portion) manufactured such that it is shaped and configured to define one or more controllably expandable sections 40. The annuloplasty structure 22 includes a flexible sleeve 26 shaped and configured to define a lumen therethrough. The controllably expandable sections 40 enable the annuloplasty structure 22 to be delivered to the annulus of a heart valve (e.g., typically, but not necessarily, a mitral valve or a tricuspid valve) of a patient in a shortened state. The controllably expandable sections 40 enable the annuloplasty structure 22 to be controllably expanded once in the patient's body.

[0183] Each controllably expandable segment 40 may comprise a corresponding portion of the flexible material of the sleeve 26. During manufacture of the sleeve 26, each segment 40 defining that 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. Figure 1 As shown in , this telescopic folding enables compression of a portion of the sleeve 26 without affecting the overall inner diameter of the sleeve 26. In addition, this telescopic folding enables subsequent expansion of each segment 40 along the longitudinal axis 21.

[0184] When in the compressed state, each controllably expandable segment 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 controllably expandable segment 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.

[0185] Each segment 40 may be folded to form a pocket 43 between the layers of the folded portion of the segment 40. The pocket 43 may have a longitudinal length L13 of 6.5-9.5 mm, e.g., 7.5 mm, measured along a pocket axis that is generally parallel to the longitudinal axis of the annuloplasty ring body portion at that portion of the annuloplasty ring body portion that includes the segment 40.

[0186] The folds of segments 40 can optionally be held together by knots 44, such as skip knots or any other easily separated ties. For some applications, sleeve 26 is manufactured so that segments 40 are biased so that each segment 40 passively expands after knot 44 is removed. For some applications, as described below, each segment 40 can be pulled apart by a corresponding control wire.

[0187] For some applications, after structure 22 is positioned against heart tissue, sleeve 26 is expanded.

[0188] like Figure 1 As shown in the following figure in , after a given controllable expansion segment 40 is expanded, a tissue anchor 32 or other attachment device can be used to anchor or attach a segment 42 of the sleeve 26 adjacent to the currently expanded controllable expansion segment 40 to the heart tissue. Although the tissue anchor 32 is depicted as a helical anchor that can be rotated or screwed into the tissue in various embodiments and drawings herein, 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 expansion of the first controllable expansion segment 40 but before the expansion of the second controllable expansion segment 40 enables the operating physician to alternate between expansion and anchoring, and enables the operating physician to control the overall expansion amount of the sleeve 26. After a sufficient amount of the sleeve 26 is anchored to the annular tissue 10, the physician can choose to keep the remaining controllable expansion segments 40 in their compressed state. In this manner, the system 20 minimizes the possibility of any excess sleeve 26 interfering with the heart valve. Additionally, with the system 20, the physician need not measure the size of the annulus prior to positioning the annuloplasty ring structure 22. In this manner, the structure 22 accommodates and conforms to all native annulus sizes.

[0189] For some applications, each segment 42 is marked with a radiopaque marker. For some applications, each segment 42 is designated as an anchor designated segment. In an exemplary application, the structure 22 includes a plurality of controllably expandable segments 40 that are alternately arranged with a plurality of anchor designated segments 42.

[0190] The sleeve 26 may include a braided fabric mesh, for example, including polyethylene terephthalate, Dacron (TM), other materials, etc. The main body portion 23 (e.g., sleeve 26) may be configured to be arranged only partially around the heart valve annulus (i.e., in a C-shape), and to be contracted after being anchored in place to circumferentially tighten the annulus. Optionally, the main body portion may be configured to be arranged completely around the annulus. In order to tighten the annulus, the system 20 may include an actuatable adjustment mechanism or contraction mechanism. The adjustment mechanism or contraction mechanism may be part of and / or coupled to one or more of the annuloplasty structure 22, the flexible elongated contraction member 30 extending along the sleeve 26, and / or other system components (e.g., a catheter, etc.). The elongated contraction member 30 may include a wire, a ribbon, a rope, or a band, 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 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 rope structure.

[0191] The actuatable adjustment mechanism or contraction mechanism can be configured in a variety of ways. For some applications, for example, the actuatable adjustment mechanism includes a spool or rotating member around which the contraction member can 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 a user to apply tension to the contraction member. For some applications, the actuatable adjustment mechanism includes a catheter or multiple catheters that are configured to interact with each other to pull the contraction member proximally and / or tension it to cause the annuloplasty structure to contract (e.g., one catheter grips the contraction member and allows the contraction member to be pulled, while another catheter provides resistance to the annuloplasty structure, etc.). Other applications are also possible.

[0192] After the physician has positioned the structure 22 along the annulus and has expanded any number of controllably expandable segments 40, the annuloplasty structure 22 is deflated using the deflation member 30. For some applications, the deflation member 30 is coupled to an actuatable deflation mechanism, such as described in U.S. Patent Application Publication Nos. 2014 / 0309661 to Sheps et al. and / or 2015 / 0272734 to Sheps et al., which are incorporated herein by reference. Additionally, implantation of the structure 22 may be accomplished using any of the methods described in the '661 and / or '734 applications.

[0193] Figure 2-3 1 is a schematic diagram of a system 120 according to some applications, the system 120 including an implant including a structure 122 (e.g., an annuloplasty structure, an annuloplasty ring structure, etc.), the structure 122 including a body portion 123 (e.g., an annuloplasty body portion, an annuloplasty ring body portion, etc.), the body portion 123 being shaped and configured to define one or more controllable expansion sections 40. The structure 122 is generally similar to the above-referenced embodiments except as described below. Figure 1 The structure 22 is described above, and like reference numerals refer to like parts.

[0194] The structure 122 may include a single control wire 50 that is connected to all of the knots 44 and, therefore, all of the controllably expandable segments 40 (although in some embodiments, multiple control wires may be used). In an exemplary embodiment, as shown, after the control wire 50 is pulled, the wire 50 releases all of the knots 44. After all of the knots 44 are released, the sleeve 26 may be fully expanded and anchored to the tissue. Figure 2 As shown in FIG, after all controllably expandable sections 40 have been expanded, the sleeve 26 is anchored to the heart tissue using the anchor 32. That is, the structure 122 is anchored to the annulus tissue 10 only after the sleeve 26 has been expanded.

[0195] like Figure 3 As shown in , the control wire 50 can be pulled progressively and gradually, and the corresponding anchor 32 or other attachment device 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 expansion of the first controllable expansion section 40 but before the expansion of the second controllable expansion section 40 enables the operating physician to alternate between expansion and anchoring, and also enables the operating physician to control the overall expansion amount of the sleeve 26. After a sufficient amount of the sleeve 26 is anchored to the valve ring 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 possibility of any excess sleeve 26 interfering with the heart valve. In addition, using the system 120, the physician does not need to measure the size of the valve ring before positioning the annuloplasty ring structure 122. In this way, the structure 122 adapts to and fits all natural valve ring sizes.

[0196] After the physician has positioned the structure 122 along the annulus and has expanded any number of the controllably expandable segments 40, the structure 122 is collapsed using the collapse member 30. For some applications, the collapse member 30 is coupled to and / or is part of an actuable collapse mechanism or adjustment mechanism, for example, as described elsewhere herein and / or as described in U.S. Patent Application Publication Nos. 2014 / 0309661 to Sheps et al. and / or 2015 / 0272734 to Sheps et al. (which are incorporated herein by reference). In addition, implantation of the structure 122 may be accomplished using any of the methods described in the '661 and / or '734 applications.

[0197] Figure 4 2 is a schematic diagram of a system 220 according to some applications, the system 220 including an implant including 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 sections 40. The structure 222 is generally similar to the above-referenced embodiments except as described below. Figure 1 The structure 22 is described above, and like reference numerals refer to like parts.

[0198] The structure 222 may include a plurality of control wires, such as wires 50a, 50b, and 50c. That is, the structure 222 may include control wires 50 corresponding to each controllable expansion segment 40. Each of the control wires 50a, 50b, and 50c may be coupled to a knot 44 of a corresponding controllable expansion segment 40. After each corresponding control wire 50 is pulled, as shown, the wire 50 releases all knots 44 of the corresponding controllable expansion segment.

[0199] In an exemplary application, after the control wire 50a has been pulled and the segments 40 have expanded, the 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 after the expansion of the first controllably expandable segment 40 but before the expansion of the second controllably expandable segment 40 by the control wire 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 is anchored to the annular tissue 10, the physician can choose to keep the remaining controllably expandable segments 40 in their compressed state. In this way, the system 20 minimizes the possibility of any excess sleeve 26 interfering with the heart valve. In addition, using 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 accommodates and adapts to all native annular sizes.

[0200] After the physician has positioned the structure 222 along the annulus and has expanded any number of controllably expandable segments 40, the annuloplasty structure 222 is contracted using the contraction member 30 independent of any remaining control wires 50 coupled to the main body of the structure 222. For some applications, the contraction member 30 is coupled to and / or is part of an actuatable contraction mechanism or adjustment mechanism, for example, as described elsewhere herein and / or as described in U.S. Patent Application Publication Nos. 2014 / 0309661 to Sheps et al. and / or 2015 / 0272734 to Sheps et al. (which are incorporated herein by reference). In addition, implantation of the structure 222 may be accomplished using any of the methods described in the '661 and / or '734 applications.

[0201] Figure 5 2 is a schematic diagram of a system 250 according to some applications, the system 250 including an implant including a structure 252 (e.g., an annuloplasty structure, an annuloplasty ring structure, etc.), the structure 252 including a body portion (e.g., an annuloplasty body portion, an annuloplasty ring body portion, etc.) shaped and configured to define one or more controllably expandable sections 40. The structure 252 is generally similar to the above-referenced embodiments except as described below. Figure 1 The structure 22 is described above, and like reference numerals refer to like parts.

[0202] Structure 252 includes one or more control wires 50. For some applications, structure 252 includes a control wire 50 corresponding to each controllable expansion section 40. The corresponding portion of the control wire 50 is reversibly coupled directly to the controllable expansion section 40 of the material of sleeve 26 at the coupling point 254. After pulling the control wire 50, as shown, the wire 50 actively pulls the material of sleeve 26 to promote expansion of the controllable expansion section 40.

[0203] As shown in the example application, after the control wire 50 has been pulled and the segment 40 has expanded, the 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 after the expansion of the first controllably expandable segment 40 but before the expansion of the second controllably expandable segment 40 by the control wire 50 enables the operating physician to alternate between expansion and anchoring, and enables the operating physician to control the overall expansion amount of the sleeve 26. After a sufficient amount of the sleeve 26 is anchored to the valve ring, the physician can choose to keep the remaining controllably expandable segments 40 in their compressed state. In this way, the system 250 minimizes the possibility of any excess sleeve 26 interfering with the heart valve. In addition, using the system 250, the physician does not need to measure the size of the valve ring before positioning the annuloplasty ring structure 252. In this way, the structure 252 adapts to and fits all native valve ring sizes.

[0204] After the physician has positioned the structure 252 along the annulus and has expanded any number of controllably expandable segments 40, the annuloplasty structure 252 is contracted using the contraction member 30 independent of any remaining control wires 50 coupled to the main body of the structure 252. For some applications, the contraction member 30 is coupled to and / or is part of an actuatable contraction mechanism or adjustment mechanism, for example, as described elsewhere herein and / or as described in U.S. Patent Application Publication Nos. 2014 / 0309661 to Sheps et al. and / or 2015 / 0272734 to Sheps et al. (which are incorporated herein by reference). In addition, implantation of the structure 252 may be accomplished using any of the methods described in the '661 and / or '734 applications.

[0205] Fig. 6A -D is a schematic diagram of a system 420 according to some applications, the system 420 including an implant including 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.) shaped and configured to define one or more controllable expansion sections 40. The structure 422 includes a sleeve 426 and a contraction member 30. The structure 422 is generally similar to the above reference 422 except as described below. Figure 1 The structure 22 is described above, and like reference numerals refer to like parts.

[0206] The sleeve 426 can be manufactured so that the segments 40 are biased so that each segment 40 maintains its folded shape. For example, during the manufacturing process, each segment 40 can be ironed or otherwise arranged to present a folded shape. For some applications, as shown below, each segment 40 can be pulled apart by the corresponding control wire connected to it. For some applications, the segments 40 can be pulled apart by pulling on different sections of the sleeve 426, such as the ends. Fig. 6A As shown in , the structure 422 is delivered to the valve annulus in a shortened state, wherein the controllably expandable segments 40 assume their corresponding folded states, with each segment 40 assuming a length L1.

[0207] exist Figure 6B In the embodiment, after positioning the structure 422 along the annular tissue 10, the physician pulls open the first segment 40a and then drives the anchor 32 into the annular tissue 10 at the anchor designated segment 42a to maintain the current open and unfolded state of the segment 40a, so that the segment 40a currently presents a length L2, which is greater than the length L1.

[0208] For some applications, each portion 42 is marked with a radiopaque marker.For some applications, each portion 42 is designated as an anchor designated segment.

[0209] exist Figure 6C In the embodiment, the physician pulls the second segment 40b apart and then drives the anchor 32 into the annular tissue 10 at the anchor designated segment 42b to maintain the current open and unfolded state of the segment 40b, so that the segment 40b currently presents a length L2, which is greater than the length L1.

[0210] exist Fig.6D In the embodiment of the present invention, the physician determines that the total length of the structure 422 anchored to the annular tissue 10 is sufficient and therefore no further expansion of the structure 422 is required. To prevent unintentional further expansion of the segments 40c and 40d, the physician drives the corresponding tissue anchor 32 through each of the segments 40c and 40d to maintain the segments 40c and 40d in their compressed state. Subsequently, the structure 422 is contracted using the contraction member 30 to reshape the annulus.

[0211] This sequential anchoring of the sleeve 426 to the tissue immediately after expansion of the first controllably expandable segment 40a but before expansion of the second controllably expandable segment 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 is anchored to the annulus, the physician may choose to maintain the remaining controllably expandable segments 40c and 40d in their compressed states. In this manner, the system 420 minimizes the likelihood that any excess sleeve 426 will interfere with the heart valve. Additionally, using the system 420, the physician need not measure the size of the annulus prior to positioning the annuloplasty ring structure 422. In this manner, the structure 422 accommodates and fits all native annulus sizes.

[0212] The sleeve 426 may include a braided fabric mesh, for example, including polyethylene terephthalate, Dacron (TM), other materials, etc. The main body portion 23 (e.g., sleeve 426) can be configured to be arranged 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 main body portion can be configured to be arranged completely around the annulus. In order to tighten the annulus, the system 420 includes an actuatable adjustment mechanism or contraction mechanism. The adjustment mechanism or contraction mechanism can be part of the annuloplasty structure 422, the flexible elongated contraction member 30 extending along the sleeve 426, and / or one or more of the other components of the system, and / or is connected to the annuloplasty structure 422, the flexible elongated contraction member 30 extending along the sleeve 426, and / or one or more of the other components of the system. The elongated contraction member 30 may include a wire, a ribbon, a rope, or a strip, 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 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 a plurality of wires intertwined to form a rope structure. The actuatable adjustment mechanism or contraction mechanism can be configured in various ways, such as any of the ways described in other parts of this article regarding other actuatable adjustment mechanisms and / or described in other documents incorporated by reference.

[0213] After the physician has positioned the structure 422 along the annulus and has expanded any number of controllably expandable segments 40, the annuloplasty structure 422 is deflated using the deflation member 30. For some applications, the deflation member 30 is coupled to and / or is part of an actuatable deflation mechanism or adjustment mechanism, for example, as described elsewhere herein and / or as described in U.S. Patent Application Publication Nos. 2014 / 0309661 to Sheps et al. and / or 2015 / 0272734 to Sheps et al. (which are incorporated herein by reference). In addition, implantation of the structure 422 may be accomplished using any of the methods described in the '661 and / or '734 applications.

[0214] Figure 73 is a schematic diagram of a system 320 according to some applications, the system 320 including a structure 322 (e.g., an annuloplasty structure, annuloplasty ring structure, etc.), the structure 322 having a flexible body portion 332 (e.g., annuloplasty body portion, annuloplasty ring body portion, etc.), the body portion 332 including a tapered sleeve 326 and a contraction 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 having a first maximum cross-sectional measurement M1 of 4-6 mm (e.g., 5 mm) and a 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.

[0215] Any number of tissue anchors 32 or other attachment devices may be used to anchor or attach the structure 322 to the annulus of the valve. After a sufficient amount of the sleeve 326 is anchored to the annulus, the physician folds or pushes the excess portion 330 of the sleeve 326 into the cavity of the portion of the sleeve 326 that has been anchored to the annulus using a pushing tool 340. That is, the physician folds the second end of the sleeve 326 toward the first end of the sleeve 326. In this way, the system 320 minimizes the possibility that any excess sleeve 326 will interfere with the heart valve. In addition, using the system 320, the physician does not need to measure the size of the annulus before positioning the annuloplasty ring structure 322. In this way, the structure 322 accommodates and fits all native annulus sizes.

[0216] For some applications, a cutting tool (not shown) may be used to cut away excess portion 330 of sleeve 326 .

[0217] The sleeve 326 may include a braided fabric mesh, for example, including polyethylene terephthalate, Dacron (TM), other materials, etc. The main body portion 332 (e.g., sleeve 326) can be configured to be arranged 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 main body portion can be configured to be arranged completely around the annulus. In order to tighten the annulus, the system 320 includes an actuatable adjustment mechanism or contraction mechanism. The adjustment mechanism or contraction mechanism can be part of and / or coupled to one or more of the annuloplasty structure 322, the flexible elongated contraction member 30 extending along the sleeve 326, and / or other system components (e.g., a catheter, etc.). The elongated contraction member 30 may include a wire, a ribbon, a rope, or a strip, 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 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 a plurality of wires intertwined to form a rope structure. The actuatable adjustment mechanism or contraction mechanism can be configured in various ways, such as any of the ways described in other parts of this article regarding other actuatable adjustment mechanisms and / or described in other documents incorporated by reference.

[0218] After the physician has positioned structure 322 along the annulus and has pushed excess portion 330 into the lumen of the portion of sleeve 326 anchored to the heart tissue, annuloplasty structure 322 is deflated using deflation member 30. For some applications, deflation member 30 is coupled to and / or is part of an actuatable deflation mechanism or adjustment mechanism, for example, as described elsewhere herein and / or as described in U.S. Patent Application Publication Nos. 2014 / 0309661 to Sheps et al. and / or 2015 / 0272734 to Sheps et al. (which are incorporated herein by reference). In addition, implantation of structure 322 may be accomplished using any of the methods described in the '661 and / or '734 applications.

[0219] In this manner, system 320 facilitates delivery of an elongated structure or annuloplasty ring structure (e.g., structure 322, as shown) to the annulus in an elongated state, partial anchoring to the annulus, and then, after anchoring, shortening the elongated structure while maintaining the main body portion of the structure or annuloplasty ring structure intact (e.g., by not cutting or severing any portion of the main body portion), and, after shortening, contracting the structure or annuloplasty ring structure to contract and reshape the patient's annulus via contraction member 30. 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.

[0220] Thus, the system 320 provides a method for (a) delivering the structure 322 to the annulus of a patient when the body portion 332 has 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 independent of the contraction member 30 while maintaining the entire integrity of the annuloplasty body portion 332 (e.g., without cutting or severing any portion of the portion 332), and (c) after shortening, reshaping the annulus by contracting the body portion 332 using the contraction member 30. This means that the body portion 332 will only need to be contracted 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). Thus, 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.

[0221] Fig. 8A-B is a schematic diagram of a system 520 according to some applications, the system 520 including a structure 522 (e.g., an annuloplasty structure, annuloplasty ring structure, etc.), the structure 522 having a flexible body portion 523 (e.g., annuloplasty body portion, annuloplasty ring body portion, etc.), the body portion 523 including (a) a sleeve 526 having an anchor coupling region or attachment region 531 and a deformable region 530, and (b) a contraction member 30. The sleeve 526 is shaped and configured to define a cavity 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 portion of the body portion 523 proximate to 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 the vicinity of 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). In addition, the body portion 523 may include a plurality of radiopaque markings 560 that indicate to the physician where to implant the anchor 32.

[0222] 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.

[0223] Using the 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 the valve. In an exemplary application, the anchor delivery system 550 includes a tube. When the tube of the system 550 is at least arranged within the lumen of the deformable region 530, the deformable region 530 assumes a first generally linear shape, such as Fig. 8A . After a sufficient amount of sleeve 526 is anchored to the annulus, the physician removes system 550 from the lumen of sleeve 526, and deformable region 530 passively assumes a second deformed shape. As shown, by way of example and not limitation, the second deformed shape is a spiral. Thus, using system 520, the physician does not need to measure the size of the annulus prior to positioning the annuloplasty ring structure 522. In this manner, structure 522 accommodates and conforms to all native annulus sizes.

[0224] The sleeve 526 may include a braided fabric mesh, for example, including polyethylene terephthalate, Dacron (TM), other materials, etc. The main body portion 523 (e.g., sleeve 526) can be configured to be arranged 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 main body portion can be configured to be arranged completely around the annulus. In order to tighten the annulus, the system 520 includes an actuatable adjustment mechanism or contraction mechanism. The adjustment mechanism or contraction mechanism can be part of and / or coupled to one or more of the annuloplasty structure 522, the flexible elongated contraction member 30 extending along the sleeve 526, and / or other system components (e.g., a catheter, etc.). The elongated contraction member 30 may include a wire, a ribbon, a rope, or a strip, 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 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 a plurality of wires intertwined to form a rope structure. The actuatable adjustment mechanism or contraction mechanism can be configured in various ways, such as any of the ways described in other parts of this article regarding other actuatable adjustment mechanisms and / or described in other documents incorporated by reference.

[0225] After the physician has positioned structure 522 along the annulus and deformable region 530 has assumed the deformed shape, annuloplasty structure 522 is deflated using deflation member 30. For some applications, deflation member 30 is coupled to and / or is part of an actuatable deflation mechanism or adjustment mechanism, for example, as described elsewhere herein and / or as described in U.S. Patent Application Publication Nos. 2014 / 0309661 to Sheps et al. and / or 2015 / 0272734 to Sheps et al. (which are incorporated herein by reference). Additionally, implantation of structure 522 may be accomplished using any of the methods described in the '661 and / or '734 applications.

[0226] In this manner, system 520 facilitates delivery of an elongated structure or annuloplasty ring structure (e.g., structure 522, as shown) to the annulus in an elongated state, partially anchoring to the annulus, and then, after anchoring, shortening the elongated structure while maintaining the main body portion of the structure or annuloplasty ring structure intact (e.g., by not cutting or severing any portion of the main body portion), and, after shortening, contracting the structure or annuloplasty ring structure to contract and reshape the patient's annulus via contraction member 30. 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.

[0227] Thus, system 520 provides a method for (a) delivering structure 522 to a patient's annulus when body portion 523 has a first longitudinal length L5 of 122-130 mm (e.g., 125 mm), (b) after delivery, shortening body portion 523 to a second longitudinal length L6 of 90-129 mm (e.g., 100 mm) independent of contraction member 30 while maintaining the entirety of body portion or annuloplasty body portion 523 intact (e.g., not cut or severed) any portion of portion 523, and (c) after shortening, reshaping the annulus by contracting body portion 523 using contraction member 30. This means that 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 deformable region 530 is not deformed). Thus, deforming region 530 reduces the total force required to contract body portion 523 after anchoring to the annulus.

[0228] Reference now Fig. 9 , Fig. 9 6 is a schematic diagram of a system 620 that includes a structure 622 (e.g., an annuloplasty structure, annuloplasty ring structure, etc.) having a flexible body portion 623 (e.g., annuloplasty body portion, annuloplasty ring body portion, etc.) that includes a sleeve 626 and a contraction member 30, according to some applications. The body portion 623 includes the sleeve 626. The body portion 623 includes a flexible material that includes a plurality of interwoven fibers.

[0229] The first portion 650 of the plurality of interwoven fibers is oriented at an angle α of 20-70 degrees (e.g., 45 degrees) relative to the longitudinal axis 621 of the body portion 623. The second portion 652 of the plurality of interwoven fibers is oriented at an angle β of 110-160 degrees (e.g., 135 degrees) relative to the longitudinal axis 621 of the annuloplasty body portion 623. The first portion 650 and the second portion 652 of the interwoven fibers impart increased longitudinal compressibility and / or stretchability to the sleeve 626.

[0230] The sleeve 626 may include a braided fabric mesh, for example, including polyethylene terephthalate, Dacron (TM), other materials, etc. The main body portion 623 (e.g., sleeve 626) may be configured to be arranged 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 main body portion may be configured to be arranged completely around the annulus. In order 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 elongated contraction member 30 extending along the sleeve 626, and / or other components (e.g., a catheter, etc.), and / or coupled to one or more of the annuloplasty structure 622, the flexible elongated contraction member 30 extending along the sleeve 626, and / or other components (e.g., a catheter, etc.). The elongated contraction member 30 may include a wire, a ribbon, a rope, or a strip, 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 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 a plurality of wires intertwined to form a rope structure. The actuatable adjustment mechanism or contraction mechanism can be configured in various ways, such as any of the ways described in other parts of this article regarding other actuatable adjustment mechanisms and / or described in other documents incorporated by reference.

[0231] After the physician has positioned structure 622 along the annulus and has anchored or attached structure 622 to the annulus, annuloplasty structure 622 is deflated using deflation member 30. For some applications, deflation member 30 is coupled to and / or is part of an actuatable deflation mechanism or adjustment mechanism, for example, as described elsewhere herein and / or as described in U.S. Patent Application Publication Nos. 2014 / 0309661 to Sheps et al. and / or 2015 / 0272734 to Sheps et al., which are incorporated herein by reference. Additionally, implantation of structure 622 may be accomplished using any of the methods described in the '661 and / or '734 applications.

[0232] Reference now Fig.10 , Fig.107 is a schematic diagram of a system 720 including a structure 722 (e.g., an annuloplasty structure, annuloplasty ring structure, etc.) having a flexible body portion 723 (e.g., annuloplasty body portion, annuloplasty ring body portion, etc.) including a sleeve 726 and a constriction member 30, according to some applications. The body portion 723 includes the sleeve 726. The body portion 723 includes a flexible material including first longitudinal segments 730 and second longitudinal segments 732 alternating along a longitudinal length of the body portion 723.

[0233] The first longitudinal segment 730 comprises a flexible material comprising a plurality of interwoven fibers. A first portion 750 of the plurality of interwoven fibers is oriented at an angle α of 20-70 degrees (e.g., 45 degrees) relative to the longitudinal axis 721 of the annuloplasty ring body portion 723. A second portion 752 of the plurality of interwoven fibers is oriented at an angle β of 110-160 degrees (e.g., 135 degrees) relative to the longitudinal axis 721 of the annuloplasty ring body portion 723. The first portion 750 and the second portion 752 of the interwoven fibers impart increased longitudinal compressibility and / or stretchability to the first longitudinal segment 730.

[0234] The second longitudinal segment 732 comprises a flexible material comprising a plurality of interwoven fibers. A third portion 754 of the plurality of interwoven fibers is oriented at an angle γ of 0-15 degrees (e.g., 0 degrees or 180 degrees) relative to the longitudinal axis 721 of the annuloplasty body portion 723. A fourth portion 756 of the plurality of interwoven fibers is oriented at an angle δ of 75-90 degrees (e.g., 90 degrees) relative to the longitudinal axis 721 of the annuloplasty body portion 723. The third portion 754 and the fourth portion 756 of the interwoven fibers impart increased strength, stiffness, and / or stability to the second longitudinal segment 732. Thus, each of the second longitudinal segments 732 is designated for driving a corresponding tissue anchor 32 therethrough, i.e., the segment 732 is an anchor designated segment.

[0235] Thus, 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 (particularly where the anchor is anchored) and (ii) providing the section 730 with increased compressibility and / or stretchability (particularly where the anchor is not anchored), the structure 722 is provided with (i) sufficient strength, stiffness, and / or stability to secure the anchor 32 thereto, and (ii) sufficient compressibility and / or stretchability to accommodate a variety of annular sizes.

[0236] The sleeve 726 may include a braided fabric mesh, for example, including polyethylene terephthalate, Dacron (TM), other materials, etc. The main body portion 723 (e.g., sleeve 726) may be configured to be arranged 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 main body portion may be configured to be arranged completely around the annulus. In order 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 722, the flexible elongated contraction member 30 extending along the sleeve 726, and / or other components (e.g., a catheter, etc.), and / or coupled to one or more of the annuloplasty structure 722, the flexible elongated contraction member 30 extending along the sleeve 726, and / or other components (e.g., a catheter, etc.). The elongated contraction member 30 may include a wire, a ribbon, a rope, or a strip, 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 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 a plurality of wires intertwined to form a rope structure. The actuatable adjustment mechanism or contraction mechanism can be configured in various ways, such as any of the ways described in other parts of this article regarding other actuatable adjustment mechanisms and / or described in other documents incorporated by reference.

[0237] After the physician has positioned structure 722 along the annulus and has anchored or attached structure 722 to the annulus, annuloplasty structure 722 is deflated using deflation member 30. For some applications, deflation member 30 is coupled to and / or is part of an actuatable deflation mechanism or adjustment mechanism, for example, as described elsewhere herein and / or as described in U.S. Patent Application Publication Nos. 2014 / 0309661 to Sheps et al. and / or 2015 / 0272734 to Sheps et al. (which are incorporated herein by reference). In addition, implantation of structure 722 may be accomplished using any of the methods described in the '661 and / or '734 applications.

[0238] Therefore, the first longitudinal section 730 is more compressible than the second longitudinal section 732. Thus, the first longitudinal section 730 reduces the total compressive force imparted to the main body portion 723 by the contraction member 30 during contraction of the structure 722.

[0239] Reference now Fig.11 , Fig.11820 according to some applications, the system 820 includes a structure 822 (e.g., annuloplasty structure, annuloplasty ring structure, etc.), the structure 822 having a flexible body portion (e.g., annuloplasty body portion, annuloplasty ring body portion, etc.) that includes a sleeve 826 and a contraction member 30. The body portion 823 includes a flexible material that includes first longitudinal segments 730 and second longitudinal segments 732 that alternate along the longitudinal length of the body portion 823 and along the longitudinal axis 821 of the structure 822. The structure 822 is generally similar to the above-referenced embodiments except as described below. Fig.10 Structure 722 is described, and like reference numerals refer to like parts.

[0240] like Fig.11 As shown in FIG. 8 , the sleeve 826 defines a second longitudinal section 732 only at the region through which the tissue anchor 32 is deployed, i.e., at the portion of the sleeve 826 sidewall designated to rest against the annular tissue 10. The section 732 may be disposed opposite the retraction member 30. Fig.10 - Each of its display segments 732 occupies 360 degrees of the circumference of the sleeve 726, Fig.11 Each segment 732 of structure 822 occupies 75-180 degrees of the circumference of sleeve 826. In this way, a large portion of sleeve 826 includes segments 730, so that sleeve 826 exhibits a high degree of compressibility and / or expandability.

[0241] After the physician has positioned structure 822 along the annulus and has anchored or attached structure 822 to the annulus, the annuloplasty structure 822 is contracted using contraction member 30. For some applications, contraction member 30 is coupled to and / or is part of an actuatable contraction mechanism or adjustment mechanism, for example, as described elsewhere herein and / or as described in U.S. Patent Application Publication Nos. 2014 / 0309661 to Sheps et al. and / or 2015 / 0272734 to Sheps et al. (which are incorporated herein by reference). In addition, implantation of structure 822 may be accomplished using any of the methods described in the '661 and / or '734 applications.

[0242] Reference now Fig.12 , Fig.12is a schematic diagram of a system 920 that includes a structure 922 (e.g., an annuloplasty structure, annuloplasty ring structure, etc.) having a flexible body portion 923 (e.g., annuloplasty body portion, annuloplasty ring body portion, etc.) that includes a sleeve 926 and a contraction member 30, according to some applications. The body portion 923 includes a flexible material that includes first and second longitudinal segments 932, 930 that alternate along a longitudinal length of the body portion 923 and along a longitudinal axis 921 of the structure 922.

[0243] Each of the first segments 932 defines a compressible segment having a compressible segment wall having a first thickness T1 of 0.05-0.1 mm (e.g., 0.07 mm). Each of the second segments 930 defines an anchor-designated segment having an anchor-designated wall having 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 thereby imparts stiffness and / or stability to the corresponding segment 930 in the sleeve 926 through which the corresponding anchor 32 is deployed. For some applications, each segment 930 is marked with a radiopaque marker.

[0244] The first longitudinal section 932, due to its corresponding thickness, is more highly compressible than the second longitudinal section 930. Thus, the first longitudinal section 932 reduces the overall compressive force imparted to the body portion 923 by the contraction member 30 during contraction of the structure 922.

[0245] The sleeve 926 may include a braided fabric mesh, for example, including polyethylene terephthalate, Dacron (TM), other materials, etc. The main body portion 923 (e.g., sleeve 926) can be configured to be arranged only partially around the heart valve annulus (i.e., in a C-shape), and after being anchored in the appropriate position, be contracted to circumferentially tighten the annulus. Optionally, the main body portion can be configured to be arranged completely around the annulus. In order to tighten the annulus, the system includes an actuatable adjustment mechanism or contraction mechanism. The adjustment mechanism or contraction mechanism can be part of one or more of the annuloplasty structure 922, the flexible elongated contraction member 30 extending along the sleeve 926, and / or other components (e.g., a catheter, etc.), and / or is connected to one or more of the annuloplasty structure 922, the flexible elongated contraction member 30 extending along the sleeve 926, and / or other components (e.g., a catheter, etc.). The elongated contraction member 30 may include a wire, a ribbon, a rope, or a strip, 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 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 a plurality of wires intertwined to form a rope structure. The actuatable adjustment mechanism or contraction mechanism can be configured in various ways, such as any of the ways described in other parts of this article regarding other actuatable adjustment mechanisms and / or described in other documents incorporated by reference.

[0246] After the physician has positioned structure 922 along the annulus and has anchored or attached structure 922 to the annulus, annuloplasty structure 922 is deflated using deflation member 30. For some applications, deflation member 30 is coupled to and / or is part of an actuatable deflation mechanism or adjustment mechanism, for example, as described elsewhere herein and / or as described in U.S. Patent Application Publication Nos. 2014 / 0309661 to Sheps et al. and / or 2015 / 0272734 to Sheps et al., which are incorporated herein by reference. Additionally, implantation of structure 922 may be accomplished using any of the methods described in the '661 and / or '734 applications.

[0247] Reference now Fig.13A -C, Fig.13A -C is a schematic diagram of a system 1000 according to some applications, the system 1000 includes a structure 1020 (e.g., annuloplasty structure, annuloplasty ring structure, etc.), the structure 1020 having a flexible body portion 1023 (e.g., annuloplasty body portion, annuloplasty ring body portion, etc.), the body portion 1023 including the sleeve 26 and the contraction member 30. Note that the annuloplasty structure 1020 may include the annuloplasty structure 1020 as referred to herein. Figure 1-12 Any annuloplasty structure or annuloplasty ring structure described herein. In addition, structure 1020 may include a contraction mechanism 1040 that includes and / or is coupled to a 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). In addition, implantation of structure 1020 may be accomplished using any of the methods described in the '661 and / or '734 applications.

[0248] exist Fig.13A In the embodiment of the present invention, an anchor delivery system 1050 or other attachment system may be used to anchor or attach a first segment 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 annular tissue 10.

[0249] exist Fig. 13B , anchor delivery system 1050 is used to compress second segment 1060 of annuloplasty body portion 1023 toward first segment 1060 of annuloplasty body portion 1023. For some applications, system 1050 can reversibly engage and be reversibly coupled to a portion of sleeve 26 during compression of second segment 1060. For example, anchor driver 1052 can reversibly ensnare a portion of sleeve 26.

[0250] exist Fig. 13C In FIG. 1 , anchor delivery system 1050 is used to drive tissue anchor 32 through the currently compressed second section 1060 of body portion 1023. For some applications, tissue anchors may be delivered downstream of section 1060. Note that Fig.13A -C shows, by way of example and not limitation, compression of only a single section 1060 of the body portion 1023. Sequential anchoring or attachment of the sleeve 26 to tissue can be accomplished immediately or immediately after compression of the corresponding section of the body portion 1023, which enables the operating physician to alternate between compression and anchoring, and also enables the operating physician to control the overall amount of compression of the sleeve 26. In this manner, 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 prior to positioning the annuloplasty ring structure 1020. In this manner, the structure 1020 accommodates and fits all native annulus sizes.

[0251] Figure 14-15 This article is based on the corresponding application reference Figure 1-13C Corresponding flow charts of at least some of the steps in the corresponding techniques described.

[0252] Fig.14A method 1200 is shown for delivering a structure (e.g., annuloplasty structure, annuloplasty ring structure, etc.) in an elongated state and subsequently shortening the structure prior to contraction. In step 1210, a structure or "annuloplasty structure" (which may be any annuloplasty structure described herein or a similar structure) is delivered to the annulus and / or atrium in an elongated state. In step 1220, the annuloplasty structure is shortened independent of contraction member 30 while maintaining the main body portion of the annuloplasty structure intact (e.g., by not cutting or severing any portion of the main body portion).

[0253] For some applications, the annuloplasty structure is then anchored to the annular tissue after it has been shortened as determined by the operating physician (step 1230). Optionally, shortening and anchoring of the annuloplasty structure are performed alternately, as per step 1240. This means that the annuloplasty structure may be partially shortened and then anchored to the annular tissue using a first tissue anchor. Subsequently, the annuloplasty structure may be partially shortened again and then anchored to the annular tissue using a second tissue anchor. Finally, in step 1250, the annulus is reshaped by contracting the annuloplasty structure using contraction member 30.

[0254] Reference now Figure 7 , 8, 13A-C, 14 and 17A-F. Note that this article refers to Fig.14 The method 1200 described herein may be adapted for use with reference to Figure 7 , 8, 13A-C and 17A-F described systems and apparatus.

[0255] Fig.15 A method 1300 is shown for delivering a structure (e.g., annuloplasty structure, annuloplasty ring structure, etc.) in a shortened state and subsequently expanding the structure prior to contraction. In step 1310, an annuloplasty structure (which may be any annuloplasty structure described herein or a similar structure) is delivered to the annulus and / or atrium in a shortened state. In step 1320, the annuloplasty structure is at least partially expanded independent of contraction member 30 while maintaining a main body portion of the annuloplasty structure intact (e.g., by not cutting or severing any portion of the main body portion).

[0256] For some applications, the annuloplasty structure is anchored to the annular tissue only after it has been expanded as determined by the operating physician (step 1330). Optionally, expansion and anchoring of the annuloplasty structure are alternated, as per step 1340. This means that the annuloplasty structure may be partially expanded and then anchored to the annular tissue using a first tissue anchor. Subsequently, the annuloplasty structure may be partially expanded again and then anchored to the annular tissue using a second tissue anchor. Finally, in step 1350, the annulus is reshaped by contracting the annuloplasty structure using contraction member 30.

[0257] Reference now Figure 1-5 , 6A-D, 15, 18A-C and 19. Note that this article refers to Fig.15 The method 1200 described herein may be adapted for use with reference to Figure 1-5 , 6A-D, 18A-C and 19 described systems and devices.

[0258] Reference now Fig.16 , Fig.16 1 is a schematic diagram of a system 1600 including a structure 1622 (e.g., an annuloplasty structure, annuloplasty ring structure, etc.) having a flexible body portion 1623 (e.g., annuloplasty body portion, annuloplasty ring body portion, etc.) including a sleeve 1626 and a contraction member 30, according to some applications. 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 cover 1630, the cover 1630 including 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 that alternate with a plurality of compressible sections 1624 defined by the windows 1628 along the longitudinal axis 1621 of the structure 1622. As shown, a corresponding tissue anchor 32 can anchor the structure 1622 to the annular tissue 10 at each anchor designated section 1625.

[0259] In some applications, each window 1628 and each compressible section 1624 has a longest dimension L7 of 12-16 mm, such as 14 mm.

[0260] Reference now Fig.10 and 16 For some applications, Fig.16 Each covering 1630 of the embodiment may include the same material of the first longitudinal section 730 and may include a flexible material including a plurality of interwoven fibers. The first portion 750 and the second portion 752 of interwoven fibers impart the first longitudinal section 730 and thereby impart Fig.16 The anchor designation section 1625 may include the same material of the second longitudinal section 732, which includes a flexible material including a plurality of interwoven fibers. The third portion 754 and the fourth portion 756 of interwoven fibers impart increased stiffness and / or stability to the second longitudinal section 732 and, thereby, to the anchor designation section 1625. For some applications, each section 1625 is marked with a radiopaque marker.

[0261] The covering 1630, due to its corresponding interwoven fibers, is more highly compressible and / or stretchable than the anchor designated section 1625. Thus, the window 1628 and covering 1630 reduce the overall compressive force imparted to the body portion 1623 by the contraction member 30 during contraction of the structure 1622.

[0262] Reference now Fig.12 and 16 For some applications, Fig.16 Each of the covers 1630 may include Fig.12 The same material of the first segment 932 of the sleeve 1626, which may define a compressible segment having a first thickness T1 of 0.05-0.1 mm (e.g., 0.07 mm). Each anchor designated segment or attachment segment 1625 may include the same material of the second segment 930, 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 segment of the sleeve 1626 through which the corresponding anchor is deployed. For some applications, each segment 1625 is marked with a radiopaque marker.

[0263] The covering 1630, due to its corresponding thickness, is more highly compressible than the anchor designated section 1625. Thus, the window 1628 and the covering 1630 reduce the overall compressive force imparted to the body portion 1623 by the contraction member 30 during contraction of the structure 1622.

[0264] Reference again Fig.16. The sleeve 1626 may include a braided fabric mesh, for example, including polyethylene terephthalate, Dacron (TM), other materials, etc. The main body portion 1623 (e.g., sleeve 1626) may be configured to be arranged only partially around the heart valve annulus (i.e., in a C-shape), and after being anchored in the appropriate position, be contracted to circumferentially tighten the annulus. Optionally, the main body portion may be configured to be arranged completely around the annulus. In order 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 elongated contraction member 30 extending along the sleeve 1626, and / or other components, and / or connected to one or more of the annuloplasty structure 1622, the flexible elongated contraction member 30 extending along the sleeve 1626, and / or other components. The elongated contraction member 30 may include a wire, a ribbon, a rope, or a strip, 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 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 a plurality of wires intertwined to form a rope structure. The actuatable adjustment mechanism or contraction mechanism can be configured in various ways, such as any of the ways described in other parts of this article regarding other actuatable adjustment mechanisms and / or described in other documents incorporated by reference.

[0265] After the physician has positioned structure 1622 along the annulus and has anchored or attached structure 1622 to the annulus, annuloplasty structure 1622 is deflated using deflation member 30. For some applications, deflation member 30 is coupled to and / or is part of an actuatable deflation mechanism or adjustment mechanism, for example, as described elsewhere herein and / or as described in U.S. Patent Application Publication Nos. 2014 / 0309661 to Sheps et al. and / or 2015 / 0272734 to Sheps et al. (which are incorporated herein by reference). Additionally, implantation of structure 922 may be accomplished using any of the methods described in the '661 and / or '734 applications.

[0266] Reference now Fig.17A -F, Fig.17A-F is a schematic diagram of a system 1700 according to some applications, the system 1700 including a structure 1722 (e.g., an annuloplasty structure, annuloplasty ring structure, etc.), the structure 1722 having a main body portion 1723, the main body portion 1723 including a flexible sleeve 1726 and a contraction member 30. The sleeve 1726 of the body portion 1723 includes a flexible material that is shaped and configured to define a cavity therethrough. As shown, the structure 1722 includes one or more connected segments 1730, for example, 1730a, 1730b, and 1730c. By way of example and not limitation, the structure 1722 is shown to include three segments 1730. Note that the structure 1722 may include any number of segments 1730. The segments 1730 are removably coupled to the main body portion 1723.

[0267] A structure 1722 is provided that includes any number of connected segments 1730 coupled to a main body portion 1723 such that the structure 1722 can be delivered to the patient's annulus in an extended state and any number of connected segments 1730 can subsequently be disconnected 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 connected segments 1730) is anchored to the annular tissue 10, the physician may choose to disconnect and remove the remaining connected segments 1730 from the patient's body. In this manner, the system 1700 minimizes the likelihood that any excess sleeve 1726 will interfere with the heart valve. Additionally, using the system 1700, the 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 annular sizes.

[0268] The main body portion 1723 and the connecting segment 1730 include a flexible sleeve 1726 .

[0269] Sleeve 1726 may include a braided fabric mesh, for example, including polyethylene terephthalate, such as Dacron (TM). The main body portion 1723 (e.g., sleeve 1726) may be configured to be arranged only partially around the heart valve annulus (i.e., in a C-shape), and after being anchored in the appropriate position, be contracted to circumferentially tighten the annulus. Optionally, the main body portion may be configured to be arranged completely around the annulus. In order to tighten the annulus, the system includes an actuatable adjustment mechanism or contraction mechanism. The adjustment mechanism or contraction mechanism can be part of the annuloplasty structure 1722, the flexible elongated contraction member 30 extending along the sleeve 1726, and / or one or more of other components, and / or is connected to the annuloplasty structure 1722, the flexible elongated contraction member 30 extending along the sleeve 1726, and / or one or more of other components. The elongated contraction member 30 may include a wire, a ribbon, a rope, or a strip, 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 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 a plurality of wires intertwined to form a rope structure. The actuatable adjustment mechanism or contraction mechanism can be configured in various ways, such as any of the ways described in other parts of this article regarding other actuatable adjustment mechanisms and / or described in other documents incorporated by reference.

[0270] 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 segments 1730 along the longitudinal axis 1721 of the structure 1722.

[0271] A first end, such as a proximal end, of the main body portion 1723 may include a first coupling 1750. A second coupling 1752 may be coupled to a first end, such as a distal end, of a first connecting segment 1730a 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 mate with each other.

[0272] A third coupling member (e.g., another coupling member 1750) may be coupled to a second end, e.g., a proximal end, of the first connection segment 1730a. A fourth coupling member (e.g., another coupling member 1752) may be coupled to a first end (e.g., a distal end) of a second connection segment 1730b disposed adjacent to the first connection segment 1730a.

[0273] The first coupling 1750 is shaped and configured to define a first cavity and includes one or more radially movable protrusions 1751. The second coupling 1752 is shaped and configured to define a second cavity and a negative space 1753 shaped and configured to receive the one or more radially movable protrusions 1751.

[0274] For some applications, radially movable protrusion 1751 of first coupling 1750 comprises a single circular protrusion, and negative space 1753 of second coupling 1752 is shaped and configured to define a single circular recess.

[0275] For some applications, the radially movable protrusions 1751 are biased to collapse radially inward in the absence of a force applied thereto. For some applications, the radially movable protrusions 1751 are not biased to collapse radially inward and are movable in response to a force applied thereto. For example, the walls of the negative space 1753 defining the second coupling 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 connecting segment 1730 (e.g., a pulling force applied to the connecting segment 1730).

[0276] System 1700 includes an anti-disconnection element 1740, such as Fig.17A . The anti-disconnection element extends longitudinally along at least the first connector 1750 and the second connector 1752 to prevent the first connector 1750 and the second connector 1752 from being disconnected. During the delivery process of the structure 1722, the anti-disconnection element 1740 extends along all the connecting segments 1730 and along a portion of the main body portion 1723, and prevents the connecting segments 1730 from being disconnected from each other and from the main body portion 1723.

[0277] For some applications, anti-decoupling element 1740 includes an elongated tube 1742. The outer surface of tube 1742 is dimensioned to seat or push against one or more protrusions 1751 to maintain protrusions 1751 within negative space 1753 and prevent first coupling member 1750 and second coupling member 1752 from decoupling.

[0278] For applications in which one or more protrusions 1751 are biased to move radially inward, the outer surface of the tube 1742 of the anti-disconnection element 1740 pushes against one or more protrusions 1751 of the first connector 1750 and maintains the protrusions 1751 within the negative space 1753 of the second connector 1752 to prevent the first connector 1750 and the second connector 1752 from disconnecting when a portion of the extended tube 1742 passes through the first and second cavities of the first and second connectors 1750, 1752, respectively.

[0279] For some applications, tube 1742 of anti-detachment element 1740 comprises a tube of an anchor delivery system 1743. For some applications, anchor delivery system 1743 comprises 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).

[0280] For some applications, anti-disconnection element 1740 includes an overtube 1744, e.g., a steerable catheter, for delivering annuloplasty structure 1722. The inner diameter of overtube 1744 is sized to maintain coupling of first coupling 1750 and second coupling 1752 when a portion of overtube 1744 surrounds first coupling 1750 and second coupling 1752.

[0281] For some applications, the anti-decoupling element 1740 includes a retraction member 30. Since the retraction member 30 extends along the main body portion 1723 and the connecting segment 1730, such as through, the retraction member 30 maintains the coupling of the first coupling member 1750 and the second coupling member 1752.

[0282] Fig. 17B An anchor delivery system 1743 is shown that delivers a tissue anchor 32 through a portion of a 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 decoupled therefrom after the anchor 32 is deployed.

[0283] 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 connection segment 1730a at the heart tissue 10 where it is to be anchored. Fig. 17C As shown in FIG. 17 , a portion of tube 1742 of system 1743 is removed from first coupling 1750 and second coupling 1752 .

[0284] For applications in which one or more protrusions 1751 of the first coupling member 1750 are biased to move radially inward, in the absence of the anti-disconnection element 1740, the protrusions 1751 move radially inward, such as Fig. 17C as shown in .

[0285] Note that for some applications, the one or more projections 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 pulling force applied to the segment 1730a from a proximal direction). In such applications, the one or more projections 1751 do not move radially inwardly in the absence of a pushing force applied thereto by the outer surface of the tube 1742.

[0286] In either application, the contraction member 30 maintains the connection of the connecting segment 1730a to the main body portion 1723 even if the tube 1742 is not disposed within the corresponding elements of the couplings 1750 and 1752 and thus one or more protrusions 1751 may be removed from the negative space 1753. In this manner, the contraction member 30 acts as an anti-detachment element 1740. In addition, because the segment 1730a is anchored to the tissue 10, the connection of the segment 1730 to the main body portion 1723 is maintained.

[0287] exist Fig.17D In the above reference Fig. 17C In the manner described, the second connection segment 1730b is anchored to the heart tissue 10 by the anchor delivery system 1743. Therefore, because the tube 1742 of the anti-detachment element 1740 extends beyond the cavity of the couplings 1750 and 1752 connecting the first connection segment 1730a and the second connection segment 1730b, one or more protrusions 1751 of the coupling 1750 of the first connection segment 1730a can be moved out from the negative space 1753 of the coupling 1752 of the second connection segment 1730b.

[0288] As mentioned above Fig. 17C Note that for applications where one or more protrusions 1751 of the first coupling 1750 are biased to move radially inward, in the absence of the anti-decoupling element 1740, the protrusions 1751 move radially inward.

[0289] In addition, if Fig. 17C It is noted that for some applications, one or more protrusions 1751 of the first coupling 1750 are not biased to move radially inward, but are only movable in response to a force applied thereto (e.g., a pulling force applied to segment 1730a from a proximal direction). In such applications, one or more protrusions 1751 do not move radially inward in the absence of a pushing force applied thereto by the outer surface of the tube 1742.

[0290] Fig.17E The third connecting segment 1730c is shown disconnected from the second connecting segment 1730b.

[0291] As mentioned above Fig. 17CNote that for applications where one or more protrusions 1751 of the first coupling 1750 are biased to move radially inward, in the absence of the anti-decoupling element 1740, the protrusions 1751 move radially inward.

[0292] In addition, if Fig. 17C It is noted that for some applications, one or more protrusions 1751 of the first coupling 1750 are not biased to move radially inwardly, but are only movable in response to a force applied thereto (e.g., a pulling force applied to segment 1730c from a proximal direction). In such applications, one or more protrusions 1751 do not move radially inwardly in the absence of a pushing force applied thereto by the outer surface of the tube 1742.

[0293] In either application, the third connection segment 1730c can be disconnected from the second connection segment after the one or more protrusions 1751 of the connector 1750 of the second connection segment 1730b are radially moved out from the negative space 1753 of the connector 1752 of the third connection segment 1730c.

[0294] As shown, the third connection segment 1730c and any other additional connection segments 1730 disposed proximally of the third connection segment 1730c move proximally away from the main body portion 1723 and the first and second connection segments 1730a, 1730b coupled to the cardiac tissue. As shown, the third connection segment 1730c and any other additional connection segments 1730 disposed proximally of the third connection segment 1730c are pulled along the contraction member 30.

[0295] Fig.17E The structure 1722 after contraction is shown. After the third connection segment 1730c and any other additional connection segments 1730 disposed proximally to the third connection segment 1730c are removed from the subject's body, the excess portion of the contraction member 30 is cut off and removed from the patient's body. A bead or lock 1760 is coupled to the contraction member 30.

[0296] After the physician has positioned the structure 1722 along the annulus and has removed any number of the connecting segments 1730, the annuloplasty structure 1722 may be collapsed using the collapse member 30, for example, by actuating a collapse mechanism 1040 that includes and / or is coupled to the collapse member 30, as described in U.S. Patent Application Publication Nos. 2014 / 0309661 to Sheps et al. and / or 2015 / 0272734 to Sheps et al. (which are incorporated herein by reference). In addition, implantation of the structure 1722 may be accomplished using any of the methods described in the '661 and / or '734 applications.

[0297] Reference now Fig.18A-C, Fig.18A -C is a schematic diagram of an exemplary system 1800 according to some applications, the system 1800 includes a variably stretchable structure 1820 (e.g., annuloplasty structure, annuloplasty ring structure, etc.), the variably stretchable structure 1820 having a flexible body portion 1823 (e.g., annuloplasty body portion, annuloplasty ring body portion, etc.), the body portion 1823 including a sleeve 1826 and a contraction member 30. The annuloplasty structure 1820 may include the annuloplasty structure 1820 described herein. Figure 1-17F Any annuloplasty structure or annuloplasty ring structure described herein. In addition, for some applications, structure 1820 may include an actuatable contraction mechanism that includes and / or is coupled to 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). In addition, implantation of structure 1820 may be accomplished using any of the methods described in the '661 and / or '734 applications.

[0298] Sleeve 1826 may include a braided fabric mesh, for example, including polyethylene terephthalate, Dacron (TM), other materials, etc. The main body portion 1823 (e.g., sleeve 1826) can be configured to be arranged 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 main body portion can be configured to be arranged completely around the annulus (e.g., a full ring or closed ring). To tighten the annulus, the system includes an actuatable adjustment mechanism or contraction mechanism. The adjustment mechanism or contraction mechanism can be part of the annuloplasty structure 1820, the flexible elongated contraction member 30 extending along the sleeve 1826, and / or one or more of other components, and / or is coupled to the annuloplasty structure 1820, the flexible elongated contraction member 30 extending along the sleeve 1826, and / or one or more of other components. The elongated contraction member 30 may include a wire, a ribbon, a rope, or a strip, 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 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 a plurality of wires intertwined to form a rope structure. The actuatable adjustment mechanism or contraction mechanism can be configured in various ways, such as any of the ways described in other parts of this article regarding other actuatable adjustment mechanisms and / or described in other documents incorporated by reference.

[0299] For some applications, sleeve 1826 is marked with one or more radiopaque markers.Sleeve 1826 can include a flexible sleeve 1826 shaped and configured to define a lumen therethrough.

[0300] exist Fig.18A In the embodiment of the present invention, the anchor delivery system 1050 or other attachment system can be used to anchor or attach the first segment 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 into the annular tissue 10. The techniques for deploying the anchors 32 through the sleeve 1826 can be practiced in conjunction with the techniques described in WO 2013 / 069019 to Sheps, which is incorporated herein by reference. Other fastening or attachment means (e.g., staples, fasteners, clamps, screws, adhesives, etc.) may be used in addition or alternatively.

[0301] exist Fig.18B , anchor delivery system 1050 is used to deliver and anchor or attach additional segments of body portion 1823 of annuloplasty structure 1820. As shown, body portion 1823 includes (1) a first segment 1822 having a first degree of stretchability, and (2) a second segment 1824 having a second degree of stretchability that is greater than the first degree of stretchability. For some applications, system 1050 can reversibly engage and reversibly grasp a portion of sleeve 1826 during stretching of second segment 1824, for example, to facilitate pulling of sleeve 1826.

[0302] The corresponding length of each of the first segment 1822 and the second segment 1824 can be controlled by the operating physician.

[0303] For some applications, the entire body portion 1823 has a flexibility that gradually increases from the distal end of the body portion 1823 toward the proximal end of the body portion 1823. That is, the second segment 1824 can be more flexible than the Fig.18B -C is shown as being longer and / or assuming a greater percentage of body portion 1823, by way of example and not limitation.

[0304] In the context of the present application (including the claims), "proximal" refers to the portion of a structure that is closer to an orifice through which the structure is introduced, while "distal" refers to the portion of the structure that is farther from the orifice through which the structure is introduced.

[0305] Additionally, for some applications, the increased stretchability of the segments 1824 imparts increased compressibility to the segments 1824. For example, the body portion 1823 may be delivered to the heart in an elongated state, partially anchored to the annulus, and then after anchoring, the elongated structure is shortened (e.g., by compression) in real time during an implantation procedure while maintaining the body portion of the structure or annuloplasty ring structure intact (e.g., by not cutting or severing any portion of the body portion), and after shortening, the structure or annuloplasty ring structure is contracted by contraction member 30 to contract and reshape the patient's annulus. For example, for some applications, after the first segment 1822 has been secured to a first length of annular tissue, it may be apparent to the physician that the path length of the remaining annular tissue is shorter than initially expected. Using the structure 1820 with the segments 1824 having increased compressibility, the physician may compress the remaining segments of the second segment 1824 to accommodate the path length of the remaining annular tissue.

[0306] After the physician has secured the first segment 1822 to the annulus (e.g., typically by anchoring with anchors 32 and / or securing with some other attachment device), 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 secured to a first length of annular tissue, it is apparent to the physician that the path length of the remaining annular tissue is longer than initially expected. Utilizing 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 annular tissue. After stretching the second segment 1824, the second segment 1824 is secured to the annulus (e.g., one or more anchors 32 are deployed through a sleeve 1826 of the second segment 1824 to secure the second segment 1824 to the annulus). In this manner, a shorter annuloplasty structure can be delivered to the annulus and stretched to a longer length only after being initially anchored to the annulus. Thus, structure 1820 comprises a partially stretchable or partially elastic structure 1820. For some applications, as body segments 1824 of body portion 1823 are stretched, the diameter of segments 1824 progressively and gradually decreases.

[0307] like Fig.18B -C, the first segment 1822 is designated for implantation between approximately the anterolateral commissure and approximately P2 (as an example and not limitation), while the second segment 1824 is designated for implantation between approximately P2 (as an example and not limitation) and the posterolateral commissure. Fig.18CVarious diameters of sleeve 1826 are shown. Note that although only second segment 1824 is shown as being more stretchable than first segment 1822, applications include annuloplasty structures whose main body has alternating segments of variable stretchability. Segments 1824 may be designated for implantation at any location along the annulus.

[0308] Because the first segment 1822 is less stretchable than the second segment 1824 , after stretching and typically before the structure 1820 contracts, the diameter D1 of the first segment 1822 is typically, but not necessarily, larger than the diameter D2 of the second segment 1824 .

[0309] For some applications, the diameter of segment 1824 does not decrease after stretching. In such applications, the diameter of segment 1824 remains the same or similar to the diameter of segment 1822. For some applications, only the inner diameter can be reduced in response to the stretching of segment 1824. For some applications, only the outer diameter can be reduced in response to the stretching of segment 1824. For any of these applications, suitable materials can be used that help control the diameter of a given section of structure 1820 in response to the application of a tensile, stretching, or compressive force. These suitable materials also help control the wall thickness of sleeve 1826.

[0310] Typically, the second segment 1824 is more stretchable than the first segment 1822 overall. For some applications, the second segment 1824 is uniform throughout. This means that the entire segment 1824 can be stretched with equal measure along the entire length of the segment 1824. For some applications, the second segment 1824 may have sections with higher stretchability and sections with lower stretchability. For such applications, the second segment 1824 may have an increased stretchability along its length, or the second segment 1824 may have sections of variable stretchability that alternate along the length of the second segment 1824.

[0311] like Fig.18B -C, as an example and not limitation, second segment 1824 occupies approximately one-third of main body portion 1824. Note that segments 1822 and 1824 may occupy any proportion. For example, segment 1824 may occupy approximately 50% or 75% of main body portion 1823. For some applications, main body portion 1823 can have an incremental stretchability along the entire length of main body portion 1823.

[0312] Although Fig.18A-C shows a sleeve 1826 comprising a braided fabric, but the sleeve 1826 may comprise other materials, such as a flexible tubular plastic, for example, having variable stretchability or variable elasticity. For some applications, the sleeve may comprise a spiral design, for example, the sleeve may comprise a flexible tubular plastic having a spiral design. For some applications, the spiral may have a variable pitch and / or diameter to help vary the flexibility of different areas of the sleeve.

[0313] Reference now Fig.18A -C. For the first segment 1822, (1) the anchors 32 (and / or other attachments) can be deployed at equal or similar distances from each other (e.g., 4-10 mm between each anchor / attachment), and (2) sleeves 1826 of equal or similar lengths can be arranged between each anchor / attachment. For the second segment 1824, (1) the anchors 32 (or other attachments) can be deployed at equal or similar distances from each other, and (2) because the sleeve 1826 is stretched, a sleeve 1826 of a shorter length can be used to span the distance between each anchor 32 in the second segment 1824 than the length of the sleeve 1826 used to span the distance between the anchors 32 in the first segment 1822.

[0314] That is, the method for implanting structure 1820 can be as follows: Fig.18A 1826 (or other accessory devices may be used). The first segment 1822 of the sleeve 1826 may be released from the anchor delivery system 1050. The first segment may then be positioned along the tissue 10, and another anchor 32 may be driven through the sleeve 1826 using the anchor driver 1052 to secure the first segment of the sleeve 1826 to the tissue 10 (or other accessory devices may be used to secure / attach this segment to the tissue). Another segment 1827 of the sleeve 1826 of the first segment 1822 may then be released from the anchor delivery system 1050 and positioned along the tissue 10, and another anchor 32a may be driven through the sleeve 1826 (as shown in FIG. 1827 ). Fig.18B) (or the additional segment 1827 may be secured / attached to tissue using another attachment device). After the physician implants the first segment 1822, the physician may expose segment 1829 of the second segment 1824 by releasing segment 1829 from the delivery system 1050. The length of segment 1829 of segment 1824 released from system 1050 is less than the length of segment 1827 of segment 1822 released from system 1050. The physician may then stretch segment 1829 to a stretched state having a length greater than the pre-stretched length of segment 1829 released from delivery system 1050. The physician can position the stretched segment 1829 along the tissue 10 and can secure segment 1829 of the second segment 1824 to the tissue 10 by, for example, attaching means such as driving tissue anchor 32d at a distance from the previous anchor 32c that is equal to or generally similar to the distance between anchors 32a and 32b used to anchor segment 1827 of the first segment 1822.

[0315] Because the second segment 1824 has increased flexibility, (1) a shorter length of sleeve 1826 can be progressively released from the delivery system 1050 to span the distance between the attachments / anchors 32 used to secure the second segment 1824, and then (2) a certain length of sleeve 1824 can be released from the delivery system 1050 to span the same distance between the attachments / anchors 32 of the first segment 1822.

[0316] That is, if the physician stretches the sleeve 1826 at section 1829 of the second segment 1824 to span the same distance between each attachment device / anchor 32, then before stretching between each anchor 32 in the second segment 1824, a shorter length of the sleeve 1826 is released from the delivery system 1050, which length is 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 segment 1822.

[0317] For some applications, stretching of segment 1824 straightens sleeve 1826 prior to anchoring sleeve 1826. This straightening of sleeve 1826 by stretching advantageously reduces the likelihood of sleeve 1826 folding in the anchoring region, thereby minimizing interference of any folded portion of sleeve 1826 with anchor 32.

[0318] Note further 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 applied by the sleeve 1826 to restore its original length after the segment 1824 is anchored) may be selected and / or configured to be insufficiently strong to cause the annulus to contract. Thus, annuloplasty is achieved only when the physician intentionally 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 sufficiently to affect the tissue 10 to which the second segment 1824 is coupled.

[0319] Reference again Fig.18A -C. System 1800 minimizes the possibility of any excess sleeve 1826 interfering with the heart valve. Fig.18B As shown in , after the first segment 1822 has been anchored, the second segment 1824 is expanded by being stretched, and then, the second segment 1824 is anchored to the heart tissue using the anchor 32. In addition, using 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.

[0320] After the physician has positioned structure 1820 along the annulus and has expanded segments 1824, annuloplasty structure 1820 is deflated using deflation member 30. For some applications, deflation member 30 is coupled to an actuatable deflation mechanism, such 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, implantation of structure 1820 may be accomplished using any of the methods described in the '661 and / or '734 applications.

[0321] Fig.19 1 is a schematic diagram of an exemplary system 1900 according to some applications, system 1900 includes a structure 1922 (e.g., annuloplasty structure, annuloplasty ring structure, etc.), structure 1922 having a body portion 1912 (e.g., annuloplasty body portion, annuloplasty ring body portion, etc.), body portion 1912 including a sleeve 1926 and a contraction member 30. For some applications, sleeve 1926 is tapered. Sleeve 1926 is shaped and configured to define a lumen therethrough. For some applications, body portion 1912 is flexible.

[0322] The structure 1922 includes one or more (e.g., two, shown as an example and not a limitation) telescoping segments 1930a and 1930b. Note that the 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, the segments 1930 may have variable lengths. The structure 1922 may be delivered to the heart in a configuration in which the telescoping segment 1930b is at least partially disposed within the cavity of the telescoping segment 1930a, and the telescoping segment 1930a is at least partially disposed within the cavity of the sleeve 1926. The telescoping segments 1930a and 1930b may be movable or slidable along the longitudinal axis 21 of the main body portion 1912.

[0323] The proximal end of sleeve 1926 includes a coupling element 1934 configured to engage and couple to coupling element 1932 at the distal end of telescoping segment 1930a. The proximal end of telescoping segment 1930a includes a coupling element 1934 configured to engage and couple to 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 an annular coupling element that provides an unobstructed passage through the cavity of entire structure 1922. Coupling elements 1932 and 1934 are typically coupled together after telescoping segment 1930 is moved to its final position.

[0324] For some applications, telescoping segment 1930 comprises the same material as sleeve 1926. For some applications, telescoping segment 1930 comprises a different material than sleeve 1826. For some applications, the wall thickness of telescoping segment 1930 can be less than the wall thickness of sleeve 1826.

[0325] The annuloplasty structure 1922 may include the Figure 1-18C In addition, for some applications, structure 1922 may include an actuatable contraction mechanism that includes and / or is coupled to 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).

[0326] The sleeve 1926 and telescoping segment 1930 may include a braided fabric mesh, for example, including polyethylene terephthalate, Dacron (TM), other materials, etc. The sleeve 1926 and telescoping segment 1930 may be configured to be arranged 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 arranged completely around the annulus (e.g., a full ring or 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 and / or coupled to one or more of the annuloplasty structure 1922, the flexible elongated contraction member 30 extending along the sleeve 1926 and telescoping segment 1930, and / or other components. The elongated contraction member 30 may include a wire, a ribbon, a rope, or a strip, 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 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 a plurality of wires intertwined to form a rope structure. The actuatable adjustment mechanism or contraction mechanism can be configured in various ways, such as any of the ways described in other parts of this article regarding other actuatable adjustment mechanisms and / or described in other documents incorporated by reference.

[0327] For some applications, sleeve 1926 and telescoping section 1930 are marked with one or more radiopaque markers. Generally, sleeve 1926 and telescoping section 1930 include a flexible sleeve 1926 that is shaped and configured to define a lumen therethrough.

[0328] An 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 annular tissue 10. Techniques for deploying the anchors 32 through the sleeve 1926 may be practiced in conjunction with the techniques described in WO 2013 / 069019 to Sheps, which is incorporated herein by reference.

[0329] As shown, body portion 1912 includes (1) first segment 1912, and (2) second segment 1916, which includes telescoping segment 1930. For some applications, anchor delivery system 1940 can reversibly engage and reversibly grasp a portion of telescoping segment 1930 during pulling and moving telescoping segment 1930.

[0330] Any number of tissue anchors 32 or other fastening or attachment devices may 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 segment 1914 of the main body portion 1912 is anchored / attached to the annulus, the physician uses the system 1940 to pull the telescoping segment 1930a out of the lumen of the sleeve 1926 and expand it. After the telescoping segment 1930a is pulled out of the lumen of the sleeve 1926, it is anchored / attached to the annular tissue 10 using the attachment device / tissue anchor 32, as shown. The physician then uses the system 1940 to pull the telescoping segment 1930b out of the lumen of the telescoping segment 1930a and expand it. After the telescoping segment 1930b is pulled out of the lumen of the telescoping segment 1930a, it can be anchored / attached to the annular tissue 10 using the attachment device / tissue anchor 32, as shown. In this manner, the system 1900 minimizes the possibility of any excess sleeve 1926 interfering with the heart valve. Additionally, using the system 1900, the physician need not measure the size of the annulus prior to positioning the annuloplasty ring structure 1922. In this manner, the structure 1922 accommodates and conforms to all native annulus sizes.

[0331] The first segment 1914 can be designated for implantation between approximately the anterolateral commissure and approximately P2, while the second segment 1916 can be designated for implantation between approximately P2 and the posterolateral commissure. The telescoping segment 1930 can be positioned at any portion of the body portion 1912.

[0332] After the physician has positioned structure 1922 along the annulus and has secured telescoping segments 1930, annuloplasty structure 1922 is deflated using deflation member 30. For some applications, deflation member 30 is coupled to an actuatable deflation mechanism, such 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, implantation of structure 1820 may be accomplished using any of the methods described in the '661 and / or '734 applications.

[0333] refer to Fig. 20 , 21A-B, 22A-C and 23, which are schematic diagrams of an annuloplasty system 2000 and its applications according to some applications. The system 2000 includes an elongated 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. Typically, the annuloplasty structure 2020 includes a contraction member 30 for contracting the body portion 2023 after the annuloplasty structure is implanted. The contraction member 30 extends along the body portion 2023. In addition, for some applications, the system may include an actuatable adjustment mechanism 2040. The adjustment mechanism can be part of and / or coupled to one or more of the structure 2020, the contraction member 30, and / or other components, 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. Optionally, the structure 2020 (and other annuloplasty structures described herein) can be contracted by tensioning the contraction member 30 by pulling on the contraction member and locking the tension using a locking element such as a crimp. Implantation of the structure 2020 can be accomplished using any of the methods described in the '661 and / or '734 applications.

[0334] 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 elongated annuloplasty structure 2020. The wall 2025 includes a sleeve 2026 and a helical member 2028. The sleeve 2026 may include a braided fabric mesh, for example, including polyethylene terephthalate, Dacron (TM), other materials, etc. The body portion 2023 (e.g., the wall 2025, such as the sleeve 2026) can be configured to be disposed only partially around the heart valve annulus (i.e., in a C-shape), and after being anchored in place, contracted to circumferentially tighten the annulus. Optionally, the body portion can be configured to be disposed completely around the annulus (e.g., a full or closed ring). For some applications, the body portion 2023 (e.g., the sleeve 2026) is marked with one or more radiopaque markers, for example, as described above, mutatis mutandis.

[0335] The spiral member 2028 defines a plurality of spiral turns extending in a spiral path along and around the cavity of the main body portion 2023. The spiral member 2028 is coupled to the sleeve 2026. For example, the spiral member 2028 (for example, its part, or its entirety) can be sutured or glued to the sleeve 2026. The structure 2020 shows that the spiral member 2028 is arranged on the inner side of the sleeve 2026, but the spiral member can be optionally arranged on the outer side of the sleeve. For some applications, the spiral member can be embedded in the sleeve.

[0336] Various other annuloplasty structures described herein are described as being capable of being anchored to tissue via an anchor 32 that is driven through a sleeve and into the tissue. Thus, in some applications, such sleeves are 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 Fig.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. In order to provide increased longitudinal compressibility of the main body portion 2023 (e.g., to accommodate a variety of annular ring sizes), the sleeve 2026 is made of a particularly flexible, compressible, and / or stretchable (e.g., elastically stretchable) material (e.g., a fabric). Thus, this material can be thinner, less dense, and / or weaker than the materials of other sleeves described herein. To accommodate this, the main body portion 2023 includes a helical member 2028 that is stronger than and generally stiffer than the sleeve 2026. The annuloplasty structure 2020 is anchored to the tissue by an anchor 32, which holds the helical member 2028 to the tissue, generally by being driven through the helical member ( Fig.21A -B). The helical member 2028 thus provides the strength required to anchor the annuloplasty structure 2020 and perform annuloplasty by collapsing the annuloplasty structure while the sleeve 2026 continues to perform other functions performed by other sleeves described herein, such as providing a closed lumen that reduces the likelihood of the anchor becoming an embolic object.

[0337] For some applications, helical member 2028 comprises a polymer. For some applications, helical member 2028 is metal. For some applications, helical member 2028 comprises a shape memory material. For some applications, helical member 2028 comprises a fabric.

[0338] The helical member 2028 allows the implanted annuloplasty structure 2020 to be relatively compressed for relatively small annuli, wherein the helical member has a relatively small helical pitch ( Fig.22A ), or relatively stretched for a relatively large annulus, where the helical member has a relatively small helical pitch ( Fig. 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. Fig. 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.

[0339] 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.

[0340] Fig.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. Fig.21A -B, the tissue engaging element 36 can be driven through the helical member 2028 itself.

[0341] For some applications, and such Fig.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. Fig.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.

[0342] For some applications, each helical turn of helical member 2028 is secured to tissue by a corresponding anchor 32 (e.g., Fig.22A -C). For some applications, not every helical turn is fixed by a corresponding anchor. For example, Fig.21B An unanchored helical turn is shown disposed between two anchored helical turns.

[0343] After it is anchored to the annulus, the annuloplasty structure 2020 is contracted to reduce the size of the annulus, for example, as described above, mutatis mutandis. The helical member 2028 and sleeve 2026 also facilitate this, with the helical pitch of the helical member decreasing during contraction.

[0344] For some applications, and as shown, the system 2000 includes a tool 2012 that facilitates delivery and / or anchoring of an 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 typically 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 the anchor out of the distal opening of the channel and through a portion of the wall 2025 just forward of the distal opening. After each portion of the body portion 2023 is anchored, a subsequent portion of the body portion is advanced out of the channel 2018 (e.g., by retracting the channel 2018 relative to the body portion), and then the subsequent portion is anchored.

[0345] Control of this advancement can be facilitated by the cooperation 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 main body portion 2023 can cause the helical member 2028 to tighten around the channel, thereby gripping the channel and increasing the control of the advancement of the main body portion out of the channel. For some applications, the tool 2012 includes a protrusion 2016 that extends radially outward from the channel 2018 and engages with the helical member 2028 to inhibit the helical coils engaged therewith from slipping out of the channel ( Fig.21A-B). The advancement of the main body portion 2023 out of the channel 2018 can thus be controlled by the rotation of the protrusion 2016 around 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 around its longitudinal axis. Typically, one complete rotation of the protrusion 2016 (e.g., through one complete rotation of the channel 2018), optionally in conjunction with the proximal retraction of the channel 2018, allows one complete turn of the spiral member 2028 (and the associated portion of the main body portion 2023) to be advanced out of the channel 2018.

[0346] For some applications, projection 2016 is movable relative to channel 2018, thereby providing a further degree of adjustability and / or control over the advancement of body portion 2023 out of the channel. Figures 21A-21B As shown in , the protrusion 2016 can be longitudinally slidable relative to the channel 2018. Alternatively or additionally, the protrusion 2016 can be rotatable circumferentially around the channel 2018 independently of the rotation of the channel itself.

[0347] Reference now Figure 1-23 . Components of any system and / or device shown or described herein may be combined with any other device or embodiment shown or described herein. For example, Fig. 9 The fabric shown in Fig. 8A -B in combination with the structure 522. Steps from the various methods shown or described herein may also be combined and arranged in various ways.

[0348] Reference again Figure 1-23 . Systems 20, 120, 220, 250, 320, 420, 620, 720, 820, 920, 1000, 1600, 1700, 1800, 1900 and 2000 for repairing a patient's dilated valve annulus, and methods 1200 and 1300 can be used to treat any heart valve of the 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 living animals or non-living corpses, cadaver hearts, simulators, anthropomorphic phantoms, etc. The systems for valve treatment described herein can be used to treat other annular muscles in the patient's body. For example, the systems described herein can be used to treat the sphincter in the stomach of a patient.

[0349] Reference again Figure 1-23. It is further noted that 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 of the anchoring devices and / or attachment devices 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.

[0350] Reference again Figure 1-23 Systems 20, 120, 220, 250, 320, 420, 620, 720, 820, 920, 1000, 1600, 1700, 1800, 1900, and 2000 and methods 1200 and 1300 (or subcomponents thereof) and methods described above may also be applied to any suitable tissue of a patient (e.g., gastric tissue, urinary tract, and prostate tissue).

[0351] In addition, the scope of this article includes applications described in one or more of the following:

[0352] Maisano et al., U.S. Patent Application 12 / 435,291, entitled “Adjustable repair chords and spool mechanism therefor,” filed May 4, 2009, issued as U.S. Patent 8,147,542;

[0353] U.S. Patent Application 12 / 437,103 to Zipory et al., entitled “Annuloplasty ring with intra-ring anchoring,” filed May 7, 2009, issued as U.S. Patent 8,715,342;

[0354] Maisano et al., U.S. Patent Application 12 / 548,991, entitled “Implantation of repair chords in the heart,” filed on August 27, 2009, issued as U.S. Patent 8,808,368;

[0355] PCT patent application PCT / IL2009 / 001209 to Cabiri et al., entitled “Adjustable annuloplasty devices and mechanisms therefor,” filed December 22, 2009, published as PCT publication WO 10 / 073246;

[0356] PCT Patent Application PCT / IL2010 / 000357 to Maisano et al., entitled “Implantation of repair chords in the heart,” filed May 4, 2010, published as WO 10 / 128502;

[0357] PCT Patent Application PCT / IL2010 / 000358 to Zipory et al., entitled “Deployment techniques for annuloplasty ring and over-wire rotation tool,” filed May 4, 2010, published as WO 10 / 128503;

[0358] U.S. Patent Application Publication No. 2014 / 0309661 to Sheps et al.; and / or

[0359] Sheps et al., U.S. Patent Application Publication No. 2015 / 0272734.

[0360] These applications are all incorporated herein by reference. The techniques described herein may be practiced in conjunction with the techniques described in one or more of these applications.

[0361] Those skilled in the art will recognize that the present invention is not limited to what has been specifically shown and described above. Rather, the scope of the present invention includes combinations and sub-combinations of the various features and steps described above, as well as variations and modifications of the non-prior art that those skilled in the art would think of after reading the foregoing description.

Claims

1. Equipment, including: An annuloplasty structure, the annuloplasty structure comprising: a body portion including a flexible material, the body portion being shaped to define one or more controllably expandable sections, each of the one or more controllably expandable sections having a corresponding first length; one or more control wires coupled to the one or more controllable expansion segments, the one or more control wires being movable to facilitate expansion of each of the one or more controllable expansion segments to assume a corresponding second length, the corresponding second length being greater than the corresponding first length; and A contraction member is coupled to the body portion, the contraction member being configured to contract the body portion independent of the one or more control wires.

2. The device according to claim 1, wherein each of the one or more controllable expansion segments constitutes a portion of the flexible material of the annuloplasty ring body portion, the portion being folded, and wherein the one or more control wires are passed through the folded portion of the portion.

3. The apparatus of claim 2, wherein the portion is telescopically folded in a direction away from a longitudinal axis of the body portion at the portion.

4. The apparatus of claim 2, wherein the portion is folded in such a manner that at least one pocket is formed between the layers of the folded portion of the portion, and wherein the pocket has a longitudinal length measured along a pocket axis that is generally parallel to the longitudinal axis of the main body at the portion.

5. The device of any one of claims 1-4, wherein the one or more control wires are removably coupled to the one or more controllable expansion segments, and wherein the flexible material is biased so that the one or more controllable expansion segments expand after the one or more control wires are decoupled from the one or more controllable expansion segments.

6. The device of any one of claims 1-4, wherein the one or more control wires are fixedly attached to the one or more controllable expansion segments, and wherein the one or more control wires facilitate expansion of the one or more controllable expansion segments in response to pulling on the one or more control wires.

7. The apparatus of any one of claims 1-6, wherein the one or more controllable expansion segments comprises a plurality of controllable expansion segments.

8. The apparatus of claim 7, wherein the one or more control wires include exactly one control wire that controls all of the plurality of controllable expansion segments.

9. The apparatus of claim 7, wherein the one or more control wires comprises a plurality of control wires, each of the plurality of control wires being movable to facilitate expansion of a corresponding one of the plurality of controllable expansion sections.

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