Methods and systems for annuloplasty alignment

Abstract

The present disclosure relates to a method, system, subsystem, and kit for aligning an annuloplasty ring or ring portion thereof with a native landmark in an annular target.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Provisional Application No. 63 / 078,770, filed on September 15, 2020, entitled “Method and Systems for Annuloplasty Alignment,” the entire contents of which are incorporated herein by reference. Technical Field

[0003] This disclosure relates to methods and systems for aligning annulusoplasty rings during surgical procedures. Specifically, this disclosure relates to methods and systems for aligning annulusoplasty rings or the annular portion of an annulusoplasty ring with a native reference point present at or near the annular target. Background Technology

[0004] Annulusoplasty remains a fundamental component of heart valve repair. Annulusoplasty rings can be used to restore the size and shape of the original valve annulus; prevent future annular dilation; and provide functional annular support.

[0005] For example, when the valve is closed, the dilation of the mitral valve (MV) annulus prevents the leaflets from closing completely, resulting in mitral regurgitation (MR), in which blood flows from the left ventricle into the left atrium.

[0006] In typical cases of MV repair, once the annular annuloplasty is completed and anchored to the annulus, the mobility of the central posterior leaflet is greatly reduced, resulting in valve closure becoming a single anterior leaflet process with frozen posterior support. Therefore, it is advantageous to properly position the annuloplasty ring within the annulus to ensure adequate leaflet engagement.

[0007] Similarly, tricuspid regurgitation (TR) of the tricuspid valve (TV) is believed to affect the majority of the population in the United States. Nevertheless, relatively few TV procedures are performed each year due to the various challenges associated with TR-based surgical or percutaneous transcatheter treatments.

[0008] For example, the ability to achieve proper anchoring of the annulus ring during annulus annuloplasty becomes challenging due to the relatively large size of the TV annulus (at least compared to the MV), the lack of calcification, and the dynamic 3D structure (e.g., during the cardiac cycle). Furthermore, the proximity of conduction systems such as the His bundle, which is a direct continuation of the atrioventricular (AV) node, to the muscular portion of the AV septum, near the coronary sinus ostium (at the apex of the Koch triangle), and extending through the right triangle of the central fibrous body to the ventricular septum, makes proper ring alignment a primary consideration during annulus annuloplasty.

[0009] The proposed technology aims to address the shortcomings of the current system. Summary of the Invention

[0010] In an exemplary embodiment, this document provides a method for aligning an annulusoplasty ring with at least one native reference point in an annular target. The method can be implemented in a system comprising: an annulusoplasty ring or an annular portion thereof, the annulusoplasty ring having an outer hollow tube, the annular portion having a plurality of segments, the annulusoplasty ring or the annular portion thereof operable to change the outer hollow tube from an insertion configuration to an operable configuration; an alignment member releasably coupled to the outer hollow tube via at least one coupling assembly configured to align with at least one native reference point; and a delivery catheter adapted and sized appropriately. The method comprises: accommodating an alignment member and an annular ring in an insertion configuration, wherein once the annular ring is inserted, a delivery catheter is operable to change the outer hollow tube from the insertion configuration to an operable configuration; the method includes: introducing the annular ring or an annular portion thereof into an annular target using the delivery catheter; changing the insertion configuration of the annular ring or an annular portion thereof to an operable configuration using the delivery catheter; and aligning at least one connecting component with at least one native reference point using the alignment member, thereby aligning the annular ring or an annular portion thereof with at least one native reference point in the annular target.

[0011] In another exemplary embodiment, this document provides a method for aligning an annular ring or an annular portion thereof with at least one native reference point in an annular target. The method can be implemented in a system comprising: an annular ring or an annular portion thereof, each of the annular ring or an annular portion having an outer hollow tube comprising a plurality of segments, the annular ring or an annular portion being operable to change the outer hollow tube from an insertion configuration to an operable configuration; and an alignment member comprising a pair of cannula needles, each cannula needle having a distal orifice and releasably coupled to the outer hollow tube via at least two coupling components, wherein each coupling component is coupled to the alignment member through each orifice. The method comprises: a component configured to be aligned with at least one native reference point; and a delivery conduit adapted, sized, and configured to receive an alignment component and an annular ring or its annular portion in an insertion configuration, wherein, once the annular ring is inserted, the delivery conduit is operable to change the outer hollow tube from an insertion configuration to an operable configuration, the method comprising: introducing the annular ring or its annular portion into an annular target using the delivery conduit; changing the elongated insertion configuration of the annular ring to an annular operable configuration using the delivery conduit; and aligning at least one of a pair of connecting components with at least one native reference point using the alignment component.

[0012] In yet another exemplary embodiment, each of the annulusoplasty ring or its annular portion has one or more regions, each region including a plurality of internal anchoring members located at least partially within an outer hollow tube, each anchoring member operable to selectively extend radially from the outer hollow tube and engage a portion of the annular target, wherein the method further includes: anchoring the annulusoplasty ring or its annular portion to a predetermined portion of the annular target using the plurality of anchoring members; and releasing alignment members using a delivery conduit to align the annulusoplasty ring with at least one native reference point in the annular target.

[0013] In an exemplary embodiment, a system is provided for use comprising: an annular ring or an annular portion thereof, the annular ring having an outer hollow tube, the annular portion having a plurality of segments, the annular ring or an annular portion thereof being operable to change the outer hollow tube from an insertion configuration to an operable configuration; an alignment member releasably coupled to the outer hollow tube via at least one coupling assembly configured to align with at least one native reference point; and a delivery conduit adapted, sized, and configured to receive the alignment member and the annular ring in the insertion configuration, wherein, once the annular ring is inserted, the delivery conduit is operable to change the outer hollow tube from the insertion configuration to an operable configuration, wherein, during the alignment of the annular ring or an annular portion thereof with at least one native reference point in an annular target, the following steps are performed: introducing the annular ring or an annular portion thereof into the annular target using the delivery conduit; changing the insertion configuration of the annular ring to an operable configuration using the delivery conduit; and aligning the at least one coupling assembly with at least one native reference point using the alignment member, thereby aligning the annular ring or an annular portion thereof with at least one native reference point in the annular target. Attached Figure Description

[0014] When read in conjunction with the accompanying drawings, the steps of the method for implementing the alignment system disclosed herein will become apparent from the following detailed description, which are exemplary and not limiting, and in the drawings:

[0015] Figure 1A A first exemplary embodiment of an alignment member according to an embodiment of the present disclosure is shown.

[0016] Figure 1B Show Figure 1A A magnified view of the partially marked area.

[0017] Figure 1C Show Figure 1B A magnified view of the partially marked area.

[0018] Figure 1D An exploded view of a connection component, for example, associated with a first exemplary embodiment, is shown.

[0019] Figure 2A A second exemplary embodiment of the alignment member is shown.

[0020] Figure 2B Show Figure 2A A magnified view of the partially marked area.

[0021] Figure 2C Show Figure 2B A magnified view of the partially marked area.

[0022] Figure 2D An exploded view of a connection component, for example, associated with a second exemplary embodiment, is shown.

[0023] Figure 3A A third exemplary embodiment of the alignment member is shown.

[0024] Figure 3B Show Figure 3A A magnified view of the partially marked area.

[0025] Figure 3C Show Figure 3B A magnified view of the partially marked area.

[0026] Figure 3D An exploded view of a connection component, for example, associated with a first exemplary embodiment, is shown.

[0027] Figure 3E A bracket according to one embodiment of the present disclosure is shown.

[0028] Figure 4 This is a schematic diagram of a heart valve, including some examples of native reference points.

[0029] While the methods disclosed herein can be implemented using the alignment system, various modifications and alternatives are applicable. However, the details of the methods have been illustrated by way of example in the accompanying drawings and will be described in further detail below. It should be understood, however, that this disclosure is not intended to limit it to the specific exemplary embodiments described. Rather, it is intended to cover all modifications, equivalents, and alternatives. Detailed Implementation

[0030] This document provides exemplary embodiments of methods, systems, subsystems, and kits for aligning annular annuloplasty rings or their annular portions with native reference points in an annular target. The annular target may be, for example, a pulmonary valve, mitral valve, tricuspid valve, or aortic valve.

[0031] Furthermore, typically, during a cardiac cycle without an annular ring or its annular portion implanted, the three-dimensional profile of the annulus of some of these valves is dynamic, which makes proper alignment using the disclosed methods and systems beneficial for proper valve manipulation. Additionally, in the context of this disclosure, the term an annular ring or its annular portion does not necessarily refer to a ring defining a single plane, but includes rings with other planes, such as saddle rings.

[0032] Similarly, the term "its annular portion" in the context of this disclosure refers to any portion of the ring operable to abut to form a complete annulusoplasty ring. For example, in some embodiments, the annular portion may be less than half or less than a quarter of the full ring and operable to abut other components and form a complete annulusoplasty ring.

[0033] definition:

[0034] The term "connection" includes its various forms, such as "operably connected," "linked," or "connectable," and refers to and includes any direct or indirect structural connection, link, or attachment, or the adaptation or possibility to such direct or indirect structural or operational connection, link, and attachment, including integrally formed components and components joined via or through another component or by a forming process. Indirect connections can include joining by intermediate components or adhesives, or by friction or by abutment and other means without any physical connection.

[0035] Additionally, for the purposes of this disclosure, directional or positional terms such as “top,” “bottom,” “upper,” “lower,” “side,” “front,” “forward,” “rear,” “backward,” “tail,” “above,” “below,” “left,” “right,” “radial,” “vertical,” “upward,” “downward,” “outer,” “inner,” “exterior,” “internal,” “middle,” “top,” “base,” etc., are used only for convenience in describing various exemplary embodiments of this disclosure.

[0036] Similarly, when referring to engaging elements, such as when fin 310 is engaged between a pair of release cords 305, 305', the term "engagement" and its various forms in exemplary embodiments refer to any force that readily holds fin 310 and the pair of release cords 305, 305' together against unintentional or undesirable separation forces (e.g., separation forces that may be introduced during the alignment of annular rings or their annular portions). However, it should be understood that engagement is not always required as an interlocking connection to resist separation forces of various possible types or sizes. Furthermore, the term "engagement element" in another exemplary embodiment refers to one or more coupled components, wherein at least one coupled component is configured to releasably engage another element. Thus, the term includes both single-component engagement elements and multi-component assemblies, such as the integral engagement assembly 303.

[0037] The terms “first,” “second,” etc., used herein do not indicate any order, quantity, or importance, but are used to refer to one element in relation to another. Unless otherwise stated herein or clearly contradicted by the context, the terms “a,” “an,” and “the” used herein do not indicate quantity limitation but should be interpreted to include both singular and plural forms. The suffix “(multiple)” used herein is intended to include both the singular and plural forms of the term it modifies, thereby including one or more of the term (e.g., needles (multiple) 302, 302' includes one or more needles). Throughout the specification, references to “one exemplary embodiment,” “another exemplary embodiment,” “exemplary embodiment,” etc., refer to a specific element (e.g., step, feature, structure, and / or characteristic) described in connection with the exemplary embodiment being included in at least one exemplary embodiment described herein, and may or may not be present in other exemplary embodiments. Furthermore, it should be understood that the described elements may be combined in any suitable manner in the various exemplary embodiments.

[0038] In the context of this disclosure, the term "operable" means that a system and / or apparatus or a component or step is fully functional, appropriately sized, adapted, and calibrated, including elements that are used to and meet applicable operability requirements to perform said function upon activation, coupling, implementation, actuation, effectiveness, or realization. In the context of a system, the term "operable" means that the system is fully functional and calibrated, having the necessary elements and mechanisms for and meeting applicable operability requirements to perform said function upon user execution.

[0039] In the context of this disclosure, the term “butt” refers to articles that are in direct physical contact with each other, although these articles may not be attached, fixed, fused, glued, sewn or welded together.

[0040] In the context of this disclosure, the term "native reference point" is used to describe a unique identifiable anatomical feature, including but not limited to the right fibrous triangle, left fibrous triangle, interleaflet triangle, posterior-anterior tricuspid junction, or a combination of one or more of the foregoing.

[0041] In the context of this disclosure, the term “alignment” is a broad term and generally refers to, but is not limited to, a fixed angular relationship between, and at least at, a native reference point, between about 0 degrees and about 180 degrees, between markings on at least one connecting component, delivery catheter or annulus annuloplasty ring or its annular portion.

[0042] In the context of this disclosure, the term "hairpin" is not intended to be limited to a U-shaped conductor, but generally refers to a separate wire segment with two ends, regardless of whether a U-shaped portion is included between the ends.

[0043] In the context of this disclosure, the term "cannula needle" refers to any internal component of a device such as a delivery conduit, and specifically includes a "wire" having a proximal end, a distal end, and a functional tip designed to perform or assist in a specified procedure. More precisely, a cannula needle is defined as a flexible device mounted within and capable of passing through a delivery conduit. In other words, the disclosed cannula needle relates to a flexible device having an eyelet located at a distal end. The cannula needle is resilient and is therefore constructed to be easily bent but can be pushed along its length.

[0044] In the context of this disclosure, the term "saddle-shaped" is used herein to refer to a valvular annulus ring typically made of two arcuate members, each annular portion having a vertex and two annular portions connecting the two ends of the annular portions. The vertex of the annular portion in one member may be in the same or opposite direction to the other member. The formed ring may typically be D-shaped.

[0045] A more comprehensive understanding of the methods, systems, subsystems, and kits for aligning a valve annuloplasty ring or its annular portion with a native reference point in an annular target can be obtained by referring to the accompanying drawings. These drawings (also referred to herein as “Figures”) are merely schematic representations for convenience and ease of illustrating this disclosure and are therefore not intended to indicate the relative size, scale, and dimensions of the apparatus or its components, and / or define or limit the scope of the exemplary embodiments. Although specific terms are used in the following description for clarity, these terms are intended to refer only to specific structures of the exemplary embodiments chosen for illustration in the drawings and are not intended to define or limit the scope of this disclosure. It should be understood in the drawings and the following description that similar reference numerals refer to components having similar functions.

[0046] Turn now Figure 1A , Figure 1BIt illustrates the annular valvularization ring 100 and the annular target that can be implemented in system 10 (e.g., see...). Figure 4 At least one native reference point in (e.g., see 501-504) Figure 4 An exemplary embodiment of the alignment method (511, 512) includes: an annular annuloplasty ring 100 or an annular portion thereof (not shown), the annular annuloplasty ring 100 having an outer hollow tube 101, the outer hollow tube 101 optionally covered by a cannula 1010, the annular portion having a plurality of segments (not shown, e.g., see, commonly assigned, filed March 12, 2019, entitled "STABLIZING AND ADJUSTING TOOLFOR CONTROLLING A MINIMALLY INVASIVE MITRAL / TRICUSPID VALVE REPAIR") U.S. Application 16 / 702338 (hereinafter referred to as "Application '338"), which is incorporated herein by reference in its entirety, is a valve annuloplasty ring 100 or an annular portion thereof, operable to change the external hollow tube 101 from an insertion configuration to an operable configuration; an alignment member 102, releasably coupled to the external hollow tube 101 via at least one coupling assembly 103, and the at least one coupling assembly 103 being configured to align with at least one native reference point (e.g., see [reference]). Figure 4 511, 512); and delivery catheter 104 (e.g., see application '338), adapted, sized, and configured to receive alignment member 102 and an annular ring 100 or its annular portion in an insertion configuration, wherein, once the annular ring 100 or its annular portion is inserted, delivery catheter 104 is operable to change the outer hollow tube 101 from an insertion configuration to an operable configuration, the method comprising: using delivery catheter 104, introducing the annular ring 100 or its annular portion into an annular target (e.g. see application '338'); Figure 4 (501-504); using the delivery catheter 104, changing the insertion configuration of the annulusoplasty ring 100 or its annular portion to an operable configuration; and using the alignment member 102, connecting at least one coupling assembly 103 to at least one native reference point (e.g., see 501-504); Figure 4 Alignment of 511, 512) thereby aligning the annular ring 100 or its annular portion with the annular target (e.g., see...). Figure 4 At least one native reference point in (e.g., see 501-504) Figure 4 Alignment of 511, 512), the method further includes: anchoring the annular annulus 100 or its annular portion to the annular target (e.g., see 511, 512). Figure 4The predetermined portion of (501-504); and the alignment member 102 is released from the annular portion of the valve annulus ring 100 or its annular portion before, during or after the anchoring step.

[0047] like Figures 1A-1D Further shown, in an exemplary embodiment, the alignment member 102 is a hairpin wire (generally referring to a wire segment having two ends and including an extended U-shaped portion between the ends in the same or different planes from the ends, such as a stem-loop structure), releasably coupled to the outer hollow tube 101 by at least two coupling assemblies 103, which can be coupled by a sleeve 1010 that completely or partially covers the hollow tube 101. As shown, the outer hollow tube 101 further defines a plurality of openings 106i, the openings 106i being sized, adapted, and configured to allow a plurality of anchoring members (e.g., see application '338) to extend laterally and engage annular targets (e.g., see application '338'). Figure 4 The 501-504) valve ring. Furthermore, such as Figure 1C and Figure 1D As shown, each of the connecting assemblies 103, 103' includes: a fin 110 having a defined longitudinal axis X. L It is laterally connected to the arc-shaped top surface 1101 of the outer hollow tube 101. In other words, the longitudinal axis X of the fin 110... L The radial axis X, which is substantially perpendicular to the hollow tube 101, R .Although Figure 1C The fin 110 is shown on the ventral side of the hollow tube 101, but from... Figure 1A and Figure 1B It can be seen that this is merely for illustrative purposes. In some exemplary embodiments, the radial position of the fin 110 relative to the plane defined by the annulusoplasty ring 100 will vary based on various parameters such as the size of the annulusoplasty ring 100, the native reference point aligned thereto, the size and shape of the annular target, whether it is the complete annulusoplasty ring or its annular portion, and may be located in the ventral direction from the mid-latitude of the hollow tube 101 (e.g., see...). Figure 1C X EQ Between approximately 0 degrees and approximately 180 degrees.

[0048] As shown in the figure, fin 110 further defines a hole 111, which is located relative to the longitudinal axis X of fin 110. L lateral direction X T The upper transverse fin 110 is configured to accommodate the release rope 105 (see, for example, see...). Figures 1A-1CThe connecting assembly 103 further includes a pair of plates 112, 112', each plate 112, 112' having a top end 1121, 1121' and a bottom end 1122, 1122', and each plate 112, 112' having a top end hole 1123, 1123' defined toward the top ends 1121 and 1121' of the plates 112, 112', the holes 1123, 1123' being sized to be adapted to and configured to be transversely X-shaped to the hole 111 across the fin 110 and receiving the release rope 105. T Alignment (in other words, coaxiality); and bottom holes 1124, 1124' in each plate 112, 112', the bottom holes 1124, 1124' being sized and configured to receive and accommodate a portion of the alignment member 102, and the bottom holes 1124, 1124' being defined toward the bottom ends 1122, 1122' of the plates 112, 112'. Plates 112, 112' further define: at least one recess 1125, 1125', sized and configured to engage bridging rod 113; and bridging rod 113, configured to connect the first plate 112 and the second plate 112' respectively, wherein fin 110 is sandwiched between a pair of plates 112, 112' and engaged by a release rope 105 included in a delivery conduit 104, the release rope 105 being configured to releasably connect the pair of plates 112, 112' to fin 110 through bottom end holes 1124, 1124'.

[0049] Therefore, the step of releasing the alignment member 102 in the method disclosed in association with the above exemplary embodiments includes: using a delivery conduit (e.g., see application '338); pulling a release rope 105 to separate the plates 112, 112' from the fins 110; and retracting the alignment member 102 into the delivery conduit 104 (e.g., see application '338).

[0050] Turn now Figures 2A-2D This illustrates another exemplary implementation. For example... Figure 2A As shown, the alignment member 202 is similar to the hairpin wire alignment member 102. The alignment member 202 further defines a pair of arcuate nodules 2021, 2021, which can be releasably connected to the outer hollow tube 201 or the sleeve 2010 via connecting assemblies 203, 203' (optionally 203"), wherein the connecting assemblies 203, 203' are connected to the alignment member 202 toward the center of each arcuate nodule 2021, 2021', and the step of aligning at least one connecting assembly 203, 203' (or optionally or additionally, connecting assembly 203") includes aligning at least one of the connecting assemblies 203, 203' and 203" with at least one native reference point (e.g., Figure 4Alignment of 511, 512, or interleaf triangle, posterior-anterior tricuspid junction, and combinations thereof.

[0051] In addition, such as Figures 2B-2D As shown, each of the connecting components 203, 203', or 203" includes: a fin 210 defining a longitudinal axis X. L (For example, see) Figure 1D It is laterally connected to the outer hollow tube 201 or the sleeve 2010, and the fin 210 further defines a hole 211, which is located relative to the longitudinal axis X of the fin 210. L (For example, see) Figure 1D ) in the horizontal direction X T (For example, see) Figure 1D The upper fin spans 210. (For example...) Figure 2D As shown, the fin 210 includes an arcuate top surface 2100, the size of which is adapted and configured to abut against the outer hollow tube 201 or sleeve 2010 over a large area. It has a width W. 210 The fin 210 is further defined to form a diameter D 210 The semi-cylindrical structure with an arc-shaped recess 2101.

[0052] like Figure 2D As shown, each connecting assembly 203, 203' or 203" further includes: a bracket 213, 213', 213" having a top end 2130, the top end 2130 defining a pair of protrusions 212, 212' extending at the top and having a gap 217 therebetween, the gap 217 having a width W 217The brackets 213, 213', 213" are sized and configured to receive a portion of the fin 210 defining a transverse aperture 211. The brackets 213, 213', 213" further have a bottom end 218, defining a top aperture 215, 215' in each protrusion 212, 212', respectively. Each (top) aperture 215, 215' is sized and configured to align with the aperture 211 transversely across the fin 210 and the bottom apertures 214, 214' (defined in each of the protrusions 212, 212', respectively) (in other words, forming coaxial apertures). The brackets 213, 213', 213" are sized and configured to receive... The aligning member 202 is received and accommodated at the bottom end 218 of the support 213, 213', 213" and the arcuate knots 2021, 2021' (in the support 213, 213') or 2022 of the support 213" are defined, wherein the fins 210 are clamped between the support protrusions 212, 212', and engaged by a release rope 205 included in the delivery conduit 204 and looping through each top hole 215, 215', the top holes being configured to releasably connect the supports 213, 213', 213" to the fins 210, 210' (and optionally 210") via the release rope 205. Figure 2C and Figure 2D As further shown, during assembly, a component with a width W... 210 The bottom end 2102 of the fin 210 is accommodated within the gap 217, such that it has a diameter D that is substantially the same as the diameter D. 214 Similar diameter D 210 The arcuate recess 2101 is configured to form a coaxial covering channel together with the bottom holes 214, 214'. An inlet 216 for assembling the coupling assembly 203 is also shown in some embodiments.

[0053] Therefore, in an alternative embodiment, the step of releasing or separating the coupling assemblies 203, 203' and optionally the coupling assembly 203" from the alignment member 202 includes: using the delivery conduit 204 (e.g., see application '338); pulling the release rope 205 to separate the supports 213, 213', 213" from the fins 210, 210' and optionally the fin 210"; and retracting the release rope 205 and the alignment member 202 back into the delivery conduit 204 (e.g., see application '338).

[0054] Turn now Figures 3A-3D This illustrates yet another exemplary implementation of a system for implementing the methods disclosed herein. For example... Figure 3AAs shown, the alignment member 302 includes a pair of cannula needles 302, 302', each cannula needle 302, 302' having a distal eyelet 3020, 3020' and releasably connected to the outer hollow tube 301 via at least one connecting assembly 303, 303', wherein the connecting assemblies 303, 303' are connected to the alignment member 302 via the distal eyelets 3020, 3020'. The distal eyelets 3020, 3020' can be formed by annulating the distal end of each cannula needle 302, 302' and clamping the distal end using, for example, clamps 3021, 3021'. In this exemplary embodiment, the annular ring 300 or its annular portion is attached to an annular target (e.g., see...). Figure 4 At least one native reference point of (501-504) (e.g., see Figure 4 The step of aligning at least one connecting assembly 303, 303' with at least one native reference point (e.g., see 511, 512, or interleaflet triangle, posterior-anterior tricuspid junction, and combinations thereof) includes aligning at least one connecting assembly 303, 303' with at least one native reference point (e.g., see 511, 512, or interleaflet triangle, posterior-anterior tricuspid junction, and combinations thereof). Figure 4 Alignment of 511, 512, or interleaf triangle, posterior-anterior tricuspid junction, and combinations thereof.

[0055] like Figures 3B-3D As shown, each connecting assembly 303, 303' includes: a fin 310' defining a longitudinal axis X. L (For example, see) Figure 1D It is laterally connected to the outer hollow tube 301 or the sleeve 3010, and has an arc-shaped top surface 3100' (referring to a curved surface with a radial arc; the radius of curvature may vary depending on the end use of the surface) and a fin body 3110'. The arc-shaped top surface 3100' abuts against the hollow tube and has a width W. 310 The fin body 3110' extends from the arcuate top surface 3100' to the bottom, defining a pair of drill holes 3102', 3103', each drill hole 3102', 3103' being sized and configured to receive release ropes 305, 305'.

[0056] Figure 3E Also shown is bracket 313' (e.g., see...) Figure 3A The bracket 313' has: a top end 3030 defining a pair of flanged protrusions 3031' and 3032' extending from the base plate 319' towards the top, wherein flanges 3033' and 3034' extend laterally from the flanged protrusions 3032' and 3031' respectively, and a gap 317' with a width W exists between the flanged protrusions 3033' and 3032'. 3101 The size of the gap 317 is adapted and configured to accommodate the width W of the fin body 3110'. 310; and bottom end 3036', defining the longitudinal axis X parallel to the fin 310. L The hole 3037', wherein the defined hole 3037' having a bevel 3038' is sized and configured to receive and accommodate the eyelets 3020, 3020' of each through-hole needle 302, 302', and wherein the fin 310 is at least partially sandwiched between a pair of flanged protrusions 3031', 3032', engaged by a pair of release ropes 305, 305', the release ropes looping through the fin body 3110' included in the delivery conduit 304, whereby each release rope 305, 305' loops through a corresponding drill hole 3102', 3103' defined in the fin body 311' below the flanges 3033', 3034' of the laterally extending flanged protrusions 3032', 3031', the pair of release ropes 305, 305' being configured to releasably connect the support 313 to the fin 310.

[0057] As shown in the figure, the holes 3102' and 3103' are limited to a height h from the arcuate top surface 3100' in the fin body 3110'. 310 The flanges 3033' and 3034' are positioned at the top of the release ropes 305 and 305', and the height h of the fin body 3110' from the bottom end 3104' to the arcuate top surface 3100' is such that... 310 Equal to the height h from the bottom plate 319' to the top plate 3030. 310 This forms a single surface that abuts against the outer hollow tube 301 or the sleeve 3010.

[0058] Therefore, in an alternative embodiment, the step of releasing or separating the connecting components includes: using a delivery conduit (e.g., see application '338), pulling each release cord 305, 305' to separate the brackets 303, 303' from the fins 310, 310'; and again, using a delivery conduit 304, retracting the release cords 305, 305' and the cannula needles 302, 302' back into the delivery conduit 304 (e.g., see application '338').

[0059] In an exemplary embodiment, the annular rings 100, 200, 300, or their annular portions, have one or more regions, each region including a plurality of internal anchoring members (e.g., see application '338) at least partially located within the outer hollow tubes 101, 201, 301, each anchoring member operable to selectively (in other words, actively selected by the user without necessarily affecting other components or parts) extend radially from the outer hollow tubes 101, 201, 301, for example through a plurality of openings 106, 206, 306, and engage annular targets (e.g., see application '338'). Figure 4 Part of 501-504.

[0060] Therefore, in another exemplary embodiment, after the step of introducing the annuloplasty ring, wherein the annuloplasty ring 100, 200, 300 or its annular portion is elongated in the insertion configuration and annular or arcuate in the operable configuration (e.g., for the annular portion) in a trans-apical or trans-femoral manner (e.g., see application '338), the step of anchoring the annuloplasty ring 100, 200, 300 or its annular portion includes: deploying at least one of a plurality of anchoring members; and engaging the annular target (e.g., see application '338'). Figure 4 The predetermined portion of (501-504), thereby engaging, for example, the annular target of 502 (e.g., see...). Figure 4 The predetermined portion of (501-504) can be, for example, the rear portion 5021 of the annulus.

[0061] Therefore, in an exemplary embodiment, this document provides a method for aligning an annulusoplasty ring with at least one native reference point in an annular target, the method being implemented in a system comprising: an annulusoplasty ring or an annular portion thereof having an outer hollow tube, the annular portion having a plurality of segments, the annulusoplasty ring or the annular portion thereof being operable to change the outer hollow tube from an insertion configuration to an operable configuration; an alignment member releasably coupled to the outer hollow tube by at least one coupling assembly (meaning that the releasably coupled member will disengage upon application of reasonable manual force to the associated member (e.g., delivery catheter), the at least one coupling assembly being... The method comprises: aligning with at least one native reference point; and a delivery catheter adapted, sized, and configured to receive an alignment member and an annular ring in an insertion configuration, wherein, once the annular ring is inserted, the delivery catheter is operable to change the external hollow tube from the insertion configuration to an operable configuration, the method comprising: introducing the annular ring or an annular portion thereof into an annular target using the delivery catheter; changing the insertion configuration of the annular ring or an annular portion thereof to an operable configuration using the delivery catheter; and aligning at least one connecting component with at least one native reference point using the alignment member, thereby aligning the annular ring or an annular portion thereof with the annular target. The method further includes (i) anchoring an annulusoplasty ring or its annular portion to a predetermined portion of an annular target; and releasing the alignment member before, simultaneously with, or after the anchoring step, wherein (ii) the target is at least one of a pulmonary valve, a mitral valve, a tricuspid valve, and an aortic valve, (iii) at least one native reference point is a right fibrous triangle, a left fibrous triangle, an interleaved triangle, a tricuspid posterior-anterior junction, and a combination including one or more of the above, (iv) at least one annular target is a mitral valve or a tricuspid valve, and (v) the alignment member is a hairpin wire connected by at least two connecting components. The alignment member is releasably connected to an outer hollow tube, and includes a pair of through-hole needles, each having a distal orifice and releasably connected to the outer hollow tube via at least one coupling assembly, wherein the coupling assembly is connected to the alignment member in the orifice, wherein (vi) the alignment step includes aligning at least one coupling assembly with at least one native reference point, wherein (vii) each coupling assembly includes: a fin defining a longitudinal axis and laterally connected to the outer hollow tube, having an arcuate top surface and a fin body, the arcuate top surface abutting against the outer hollow tube, the fin body extending from the arcuate top surface to the bottom and defining a pair of boreholes, each borehole being sized and configured to receive a release rope;The support has a top end and a bottom end, the top end defining a pair of flanged protrusions extending upwards, wherein the flanges extend laterally from each flanged protrusion and there is a gap between the flanged protrusions having a width sized and configured to receive the width of the fin body, the bottom end defining a hole parallel to the longitudinal axis of the fin, the hole being sized and configured to receive and receive the eyelet of each through-hole needle, and wherein the fin is clamped between the pair of flanged support protrusions and engaged by a pair of release ropes included in a delivery conduit and passing annularly through the respective boreholes below the laterally extending flanges of the flanged protrusions, the pair of release ropes being configured to releasably connect the support to the fin, wherein (viii) the release step includes: pulling each of the release ropes, thereby separating the pair of flanged protrusions from the fin. The procedure involves: disengaging the annulus ring; and retracting the catheter needle into the delivery catheter, wherein (ix) the annulus ring has one or more regions, each region including a plurality of internal anchoring members at least partially located within the outer hollow tube, each anchoring member operable to selectively extend radially from the outer hollow tube and engage a portion of the annular target, wherein (x) the anchoring step includes: deploying at least one of the plurality of anchoring members; and engaging a predetermined portion of the annular target, wherein (xi) the annular target is the mitral valve; the original reference point is at least one of the right fibrous trigone and the left fibrous trigone; and the predetermined portion of the engaged annular target is the posterior portion of the valve annulus, wherein (xii) in the introduction step, the annulus ring is introduced transapically or transfemorally, and (xiii) the annulus ring or its annular portion is elongated in the insertion configuration and annular in the operable configuration.

[0062] In another exemplary embodiment, this document provides a method for aligning an annular ring or an annular portion thereof with at least one native reference point in an annular target. The method can be implemented in a system comprising: an annular ring or an annular portion thereof, each of the annular ring or an annular portion having an outer hollow tube comprising a plurality of segments, the annular ring or an annular portion being operable to change the outer hollow tube from an insertion configuration to an operable configuration; an alignment member including a pair of cannula needles, each cannula needle having a distal orifice and releasably coupled to the outer hollow tube via at least two coupling components, wherein each coupling component is coupled to the alignment member through each orifice and configured to align with at least one native reference point; and a delivery system. A catheter, adapted, sized, and configured to receive an alignment member and an annular ring or its annular portion in an insertion configuration, wherein, once the annular ring is inserted, the delivery catheter is operable to change the external hollow tube from an insertion configuration to an operable configuration, the method comprising: introducing the annular ring or its annular portion into an annular target using the delivery catheter; changing the elongated insertion configuration of the annular ring to an annular operable configuration using the delivery catheter; and aligning at least one of a pair of connecting components with at least one native reference point using the alignment member, (xiv) the annular target being at least one of a pulmonary valve, mitral valve, tricuspid valve, and aortic valve, (xv) the at least one native reference point being the right fibrocartilage... The method further (xvi) includes at least one of a triangular, left fibrous triangular, interleaved triangular, and tricuspid posterior-anterior junction, and includes: anchoring an annular ring or an annular portion thereof to a predetermined portion of an annular target; and releasing alignment members, wherein (xvii) each of the connecting components includes: a fin defining a longitudinal axis and laterally coupled to an outer hollow tube, having an arcuate apical surface and a fin body, the arcuate apical surface abutting the outer hollow tube, the fin body extending from the arcuate apical surface to a bottom and defining a pair of boreholes, each borehole being sized and configured to receive a release cord; and a support having a top end and a bottom end, the top end defining a pair of flanged protrusions extending upward, wherein the flanges extend from each flanged protrusion. Laterally extending, there is a gap between the flanged protrusions, the gap having a width sized and configured to accommodate the width of the fin body, the bottom end defining a hole parallel to the longitudinal axis of the fin, the hole being sized and configured to receive and accommodate the eyelet portion of each through-hole needle, and wherein the fin is clamped between a pair of flanged support protrusions, engaged by a pair of release ropes included in a delivery conduit and passing annularly through corresponding drill holes defined in the fin body below the flanges extending laterally in the flanged protrusions, the pair of release ropes being configured to releasably connect the support to the fin, wherein (xvii) the release step includes: using the delivery conduit, pulling each of the release ropes thereby separating the support from the fin;The method (xx) further includes: using a delivery conduit, retracting a release cord and a cannula needle into the delivery conduit, wherein (xix) each of the annulusoplasty ring or its annular portion has one or more regions, each region including a plurality of internal anchoring members at least partially located within an outer hollow tube, each anchoring member operable to selectively extend radially from the outer hollow tube and engage a portion of the annular target; and using the delivery conduit, releasing an alignment member from the annulusoplasty ring or its annular portion to align the annulusoplasty ring with at least one native reference point in the annular target, wherein (xxi) the anchoring step includes: deploying at least one of the plurality of anchoring members to engage the ring. The predetermined portion of the annular target; and the predetermined portion of the conjoined annular target, wherein (xxii): the annular target is the tricuspid or mitral valve; the original reference point is at least one of the right fibrous triangle and the left fibrous triangle; the predetermined portion of the conjoined annular target is the posterior edge of the valve annulus, wherein (xxiii) in the introduction step, the annulus annuloplasty ring or its annular portion is introduced transapically or transfemorally, (xxiv) the annulus annuloplasty ring or its annular portion is elongated in the insertion configuration and annular in the operable configuration, wherein (xxv) the annulus annuloplasty ring includes at least one additional annular portion that can be combined with the annular portion to form the annulus annuloplasty ring, and wherein (xxvi) once formed, the annulus annuloplasty ring has a saddle shape.

[0063] In another embodiment, this document provides a system for use comprising: an annular ring or an annular portion thereof, each of the annular ring or an annular portion thereof having an outer hollow tube comprising a plurality of segments, the annular ring or an annular portion thereof being operable to change the outer hollow tube from an insertion configuration to an operable configuration; an alignment member comprising a pair of cannula needles, each cannula needle having a distal orifice and releasably coupled to the outer hollow tube via at least two coupling components, wherein each coupling component is coupled to the alignment member via each orifice and configured to be aligned with at least one native reference point; and a delivery catheter adapted, sized, and configured to receive the alignment member and the annular ring or an annular portion thereof in the insertion configuration, wherein once the valve... Once the annulusoplasty ring is inserted, the delivery catheter is operable to change the external hollow tube from an inserted configuration to an operable configuration. During the alignment of the annulusoplasty ring or its annular portion with at least one native reference point in the annular target, the following steps are performed: using the delivery catheter, introducing the annulusoplasty ring or its annular portion into the annular target; using the delivery catheter, changing the inserted configuration of the annulusoplasty ring to an operable configuration; and using an alignment member, aligning at least one connecting component with at least one native reference point, thereby aligning the annulusoplasty ring or its annular portion with at least one native reference point in the annular target, wherein (xxvii) the annular target is at least one of the pulmonary valve, mitral valve, tricuspid valve, and aortic valve, (xxviii) to The missing primary reference point is at least one of the right fibrous triangle, left fibrous triangle, interleaflet triangle, and posterior-anterior tricuspid junction. The step further (xxix) includes: anchoring the annular annuloplasty ring or its annular portion to a predetermined portion of the annular target; and releasing the alignment member, wherein each of the (xxx) connecting components includes: a fin defining a longitudinal axis and laterally coupled to the outer hollow tube, having an arcuate apical surface and a fin body, the arcuate apical surface abutting the hollow tube, the fin body extending from the arcuate apical surface to the bottom and defining a pair of boreholes, each borehole being sized and configured to receive a release cord; and a support having a top end and a bottom end, the top end defining a pair of flanged protrusions extending upwards, wherein the flanges extend from each... The flanged protrusions extend laterally, and there is a gap between the flanged protrusions having a width appropriate to and configured to accommodate the width of the fin body. The bottom end defines a hole parallel to the longitudinal axis of the fin, the size of which is appropriate to and configured to receive and accommodate the eyelet portion of each through-hole needle. The fin is clamped between a pair of flanged support protrusions and engaged by a pair of release ropes included in a delivery conduit and passing annularly through a corresponding drill hole defined in the fin body below the flanges extending laterally from the flanged protrusions. The pair of release ropes are configured to releasably connect the support to the fin. The release step (xxxi) includes: using the delivery conduit, pulling each of the release ropes to separate the support from the fin.The steps (xxxii) and (xxxiii) further include: retracting the release cord and cannula needle into the delivery conduit using a delivery conduit; wherein the annulusoplasty ring or its annular portion has one or more regions, each region including a plurality of internal anchoring members at least partially located within an outer hollow tube, each anchoring member operable to selectively extend radially from the outer hollow tube and engage a portion of the annular target; and (xxxiv) the anchoring step includes: deploying at least one of the plurality of anchoring members to engage the annular target. The target is a predetermined portion; and the annular target is a predetermined portion, wherein (xxxv): the annular target is the tricuspid or mitral valve; the original reference point is at least one of the right fibrous trigone and the left fibrous trigone; the predetermined portion of the annular target is the posterior edge of the valve annulus, wherein (xxxvi) in the introduction step, the annulus annuloplasty ring or its annular portion is introduced transapically or transfemorally, (xxxvii) the annulus annuloplasty ring or its annular portion is elongated in the insertion configuration and annular in the operable configuration, wherein (xxxviii) the annulus annuloplasty ring includes at least one additional annular portion that can be combined with the annular portion to form the annulus annuloplasty ring, and wherein (xxxix) once formed, the annulus annuloplasty ring has a saddle shape.

[0064] While the foregoing description, in conjunction with certain exemplary embodiments, describes methods, systems, subsystems, and kits for aligning annular rings or their annular portions with at least one native reference point in the annular targets described herein, and many details have been set forth for illustrative purposes, it will be apparent to those skilled in the art that this disclosure of alignment methods that can be implemented using the systems disclosed herein is also applicable to additional embodiments, and that certain details described herein and more fully in the claims may be significantly altered without departing from the fundamental principles of this disclosure.

Claims

1. A system for aligning a valve annuloplasty ring with at least one native reference point in a ring target, the system comprising: The annulusoplasty ring has an outer hollow tube, the annulusoplasty ring includes an annular portion having multiple segments, and the annulusoplasty ring is operable to change the outer hollow tube from an insertion configuration to an operable configuration. An alignment member is releasably coupled to the outer hollow tube via at least one coupling assembly, the at least one coupling assembly being aligned with the at least one native reference point, the at least one coupling assembly comprising: A fin, defining a longitudinal axis and configured to laterally connect to the outer hollow tube, has a surface abutting the outer hollow tube and a fin body extending from the surface to the bottom, sized and configured to accommodate a release rope; and A support, configured to be releasably coupled to the fin via a release rope, has a top end defining a pair of flanged protrusions extending upwardly, wherein the flanges extend laterally from each flanged protrusion, a gap having a width sized and configured to accommodate the width of the fin body; and a bottom end defining a hole parallel to the longitudinal axis of the fin, the fin being clamped between the pair of flanged support protrusions; and A delivery catheter, adapted and configured to receive the alignment member and the annuloplasty ring in its insertion configuration. Wherein, once the annuloplasty ring is inserted, the delivery catheter is operable to change the external hollow tube from the inserted configuration to the operable configuration. The delivery catheter is configured to introduce the annulusoplasty ring into the annular target; The delivery catheter is configured to change the insertion configuration of the annulusoplasty ring to the operable configuration; and The alignment member is configured to align the at least one connecting component with the at least one native reference point, thereby aligning the annulus angioplasty ring with at least one native reference point in the annular target.

2. The system according to claim 1, in, The annuloplasty ring is configured to be anchored to a predetermined portion of the annular target; as well as The alignment member is configured to be released.

3. The system of claim 1, wherein the target is at least one of the pulmonary valve, mitral valve, tricuspid valve and aortic valve.

4. The system of claim 1, wherein the at least one native reference point is the right fibrous triangle, the left fibrous triangle, the interleaflet triangle, the posterior-anterior tricuspid junction, and a combination thereof including one or more of the above.

5. The system according to claim 4, wherein, The alignment member includes a pair of cannula needles, each cannula needle having a distal orifice and releasably connected to the outer hollow tube via at least one coupling assembly, wherein the at least one coupling assembly is connected to the alignment member via the distal orifice.

6. The system according to claim 5, wherein, At least one of the connection components is configured to align with at least one of the native reference points.

7. The system according to claim 6, wherein, The release ropes include a pair of release ropes that are included in the delivery conduit and pass in an annular manner through corresponding drill holes defined in the fin body below the laterally extending flange of the flanged protrusion, the pair of release ropes being configured to releasably connect the support to the fin.

8. The system according to claim 7, wherein Each of the release ropes is configured to be pulled to separate the pair of flanged protrusions from the fins; and The cannula needle is configured to retract into the delivery catheter.

9. The system of claim 1, wherein the annulusoplasty ring has one or more regions, each region including a plurality of internal anchoring members located at least partially within the outer hollow tube, each anchoring member operable to selectively extend radially from the outer hollow tube and engage a portion of the annular target.

10. The system according to claim 9, wherein The plurality of anchoring members are configured to be deployed to engage predetermined portions of the annular target.

11. The system according to claim 10, wherein: The annular target is the mitral valve; The native reference point is at least one of the right fiber triangle and the left fiber triangle; and The predetermined portion of the joined annular target is the rear part of the petal ring.

12. The system according to claim 1, wherein, The annuloplasty ring is configured to be introduced via the apex of the heart or via the femoral artery.

13. The system of claim 1, wherein the annulusoplasty ring is elongated in the insertion configuration and annular in the operable configuration.

14. A system for aligning a valve annuloplasty ring with at least one native reference point in a ring target, the system comprising: The annulusoplasty ring has an outer hollow tube comprising multiple segments, the annulusoplasty ring including an annular portion, the annulusoplasty ring being configured to change the outer hollow tube from an insertion configuration to an operable configuration; an alignment member including a pair of cannula needles, each cannula needle having a distal orifice, the alignment member being configured to be releasably coupled to the outer hollow tube via at least two coupling components, each coupling component including: (i) a fin defining a longitudinal axis and configured to laterally couple the outer hollow tube, having a surface abutting the outer hollow tube and a fin body extending from the surface to a bottom, the fin body being sized and configured to receive a release cord; and (ii) a support configured to be releasably coupled to the fin via the release cord and having a apex defining a apex extending upwards. The fin includes flanged protrusions, wherein the flanges extend laterally from each flanged protrusion, and a gap exists between the flanged protrusions having a width sized and configured to accommodate the width of the fin body; a bottom end defining an aperture parallel to the longitudinal axis of the fin, the fin being clamped between the pair of flanged support protrusions, wherein each coupling assembly is configured to be coupled to the alignment member through each aperture and further configured to be aligned with the at least one native reference point; and a delivery conduit adapted and configured to receive the alignment member and the annulusoplasty ring in the insertion configuration, wherein, once the annulusoplasty ring is inserted, the delivery conduit is operable to change the outer hollow tube from the insertion configuration to the operable configuration. The delivery catheter is configured to introduce the annulusoplasty ring into the annular target; The delivery catheter is configured to change the elongated insertion configuration of the annulusoplasty ring to a ring-shaped operable configuration; and The alignment member is configured to align at least one of a pair of connecting components with the at least one native reference point.

15. The system of claim 14, wherein the annular target is at least one of the pulmonary valve, mitral valve, tricuspid valve and aortic valve.

16. The system of claim 14, wherein the at least one native reference point is at least one of the right fibrous triangle, the left fibrous triangle, the interleaflet triangle, and the posterior-anterior tricuspid junction.

17. The system according to claim 14, wherein, The annuloplasty ring is configured to be anchored to a predetermined portion of the annular target; and The alignment member is configured to be released.

18. The system according to claim 17, in, The delivery conduit is configured to pull the release rope, thereby separating the support from the fins; and The delivery conduit is configured to retract the release rope and the cannula needle back into the delivery conduit.

19. The system according to claim 14, wherein, The annulusoplasty ring has one or more regions, each region including a plurality of internal anchoring members located at least partially within the outer hollow tube, each anchoring member operable to selectively extend radially from the outer hollow tube and engage a portion of the annular target.

20. The system of claim 19, wherein The plurality of anchoring members are configured to anchor the annular ring to a predetermined portion of the annular target; and The delivery catheter is configured to release the alignment member from the annulusoplasty ring, thereby aligning the annulusoplasty ring with the at least one native reference point in the annular target.

21. The system of claim 20, wherein At least one of the plurality of anchoring members is configured to be deployed to engage a predetermined portion of the annular target.

22. The system according to claim 21, wherein: The annular target is the tricuspid or mitral valve; The native reference point is at least one of the right fiber triangle and the left fiber triangle; and The predetermined portion of the joined annular target is the rear edge of the petal ring.

23. The system according to claim 14, wherein, The annuloplasty ring is configured to be introduced via the apex of the heart or via the femoral artery.

24. The system of claim 14, wherein the annulusoplasty ring is elongated in the insertion configuration and annular in the operable configuration.

25. The system of claim 14, comprising at least one additional annular portion, the at least one additional annular portion being combined with the annular portion to form the annulusoplasty ring.

26. The system of claim 25, wherein once formed, the annulusoplasty ring has a saddle shape.

Images