Stabilization and adjustment tools for controlling minimally invasive mitral / tricuspid valve repair systems

Abstract

Disclosed herein are embodiments relating to methods for performing a minimally invasive procedure comprising delivering a linear annuloplasty ring using a delivery system. In some embodiments, the annuloplasty ring can be delivered using a transseptal or transapical approach. In some embodiments, the delivery system can position the annuloplasty ring using a flexible stabilizing mechanism and / or activate one or more anchors to extend outwardly from the annuloplasty ring.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Provisional Application No. 62 / 774,651, filed December 3, 2018, the contents of which are incorporated herein by reference in their entirety. Technical Field

[0003] The present disclosure generally relates to devices for minimally invasive treatment of tricuspid valve regurgitation in humans. Background Art

[0004] Tricuspid regurgitation is a condition characterized by leakage in the tricuspid valve, which is located between the upper and lower chambers on the right side of the heart. In individuals with tricuspid regurgitation, blood leaks backward through the tricuspid valve each time the right ventricle contracts. More specifically, when the right ventricle contracts to pump blood toward the lungs, some of the blood leaks backward into the right atrium. This increases the volume of blood in the atrium, which can cause the right atrium to enlarge. The enlargement of the right atrium can lead to changes in pressure in both nearby heart chambers and adjacent blood vessels.

[0005] Functional tricuspid regurgitation is the most common type of valve pathology and is often associated with mitral valve disease. Currently, most patients with both mitral valve disease and tricuspid regurgitation receive surgical treatment of the mitral valve alone. Tricuspid regurgitation is often undiagnosed or overlooked. Progressive dilation of the tricuspid annulus may benefit from repair independent of regurgitation. Without treatment of tricuspid dilation, mitral valve disease can lead to biventricular failure and even death.

[0006] Therefore, there is a need for devices and methods for minimally invasive treatment of tricuspid valve regurgitation in humans. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] Aspects, features, benefits and advantages of the embodiments described herein will become apparent with reference to the following description, appended claims and accompanying drawings, in which:

[0008] Figure 1 An example tricuspid valve is shown in normal and dilated states.

[0009] Figure 2 An example pattern is shown cut into a hollow tube for forming a tricuspid valve annulus.

[0010] Figure 3 Another exemplary pattern for cutting into a hollow tube for forming a tricuspid valve annulus is shown.

[0011] Figure 4 The back side of the hollow tube and the pattern of cutouts for the anchor deployment windows are shown.

[0012] Figure 5Example shapes of the tricuspid annulus are shown.

[0013] Figure 6 An exemplary schematic laser cutting pattern is shown.

[0014] Figure 7 An exemplary schematic laser cut tube is shown.

[0015] Figure 8 A perspective view of an example tricuspid annulus with deployed anchors is shown.

[0016] Figure 9 A perspective view of an example tricuspid annulus with a zonal distribution is shown.

[0017] Figure 10 A perspective view of an exemplary laser-cut fluorinated ethylene propylene (FEP) material is shown.

[0018] Figure 11 An exemplary laser cutting pattern of an FEP tube is shown.

[0019] Figure 12 An exemplary laser-cut FEP material is shown in a tubular configuration.

[0020] Figure 13 Illustrative geometric views of a septal anchor are shown.

[0021] Figure 14 An example geometric view of a posterior anchor is shown.

[0022] Figure 15 An example geometric view of the anterior anchor in zone A is shown.

[0023] Figure 16 An example geometric view of the anterior anchor in region B is shown.

[0024] Figure 17 Exemplary laser cutting patterns for the back region and / or the front region are shown.

[0025] Figure 18 The laser cut pattern of the septal region is shown.

[0026] Figure 19 A detailed view of an example harpoon member is shown.

[0027] Figure 20 A detail view illustrating an anchor stop feature is shown.

[0028] Figure 21 A detail view of another exemplary anchor stop feature is shown.

[0029] Figure 22 A detail view of another exemplary anchor stop feature is shown.

[0030] Figure 23 A detail view of another exemplary anchor stop feature is shown.

[0031] Figure 24 Another example anchor stop feature and an example harpoon are shown.

[0032] Figure 25 A perspective view of an illustrative undeployed anchor positioned adjacent a deployment window is shown.

[0033] Figure 26 An illustrative view of an undeployed anchor is shown.

[0034] Figure 27 An illustrative view of a deployed anchor is shown.

[0035] Figure 28 Shown is a detail of a segment of the tricuspid annulus with deployed anchors.

[0036] Figure 29 An exemplary initial geometry of the tricuspid annulus is shown.

[0037] Figure 30 An exemplary tricuspid annulus is shown having a "D" shaped geometry.

[0038] Figure 31 Another exemplary tricuspid ring with a snap-fit ​​mechanism is shown.

[0039] Figure 32 A detailed view of an exemplary snap mechanism is shown in a closed configuration.

[0040] Figure 33 A detailed view of an exemplary snap mechanism is shown in an open configuration.

[0041] Figure 34 An isolated detail view of an exemplary snap mechanism is shown in a closed configuration.

[0042] Figure 35 Shown is an isolated detail view of an exemplary female snap mechanism.

[0043] Figure 36 A cross-sectional view of an exemplary female snap mechanism is shown.

[0044] Figure 37 A detailed view of an exemplary male snap mechanism is shown.

[0045] Figure 38 Shown is a view of an exemplary delivery system connected to a clasp.

[0046] Figure 39Another view of an exemplary delivery system connected to a ring with deployed anchors is shown with a stabilization tool in the center.

[0047] Figure 40 An illustrative view of a delivery system is shown.

[0048] Figure 41 Another illustrative view of a delivery system connected to a deployment ring is shown.

[0049] Figure 42 Another illustrative view of a delivery system connected to a ring is shown.

[0050] Figure 43 Another illustrative view of a hinge system associated with a delivery system and stabilization tool is shown.

[0051] Figure 44 An illustrative view of the delivery system connected to a fully deployed ring and stabilization tool is shown.

[0052] Figure 45 Another illustrative view of a hinge system associated with a delivery system is shown.

[0053] Figure 46 Another illustrative view of a delivery system coupled to a deployed ring while being manipulated by a stabilization tool and prior to deploying an anchor is shown.

[0054] Figure 47 Another illustrative view of a hinge system associated with a delivery system is shown.

[0055] Figure 48 Another illustrative view of a hinge system associated with a delivery system is shown.

[0056] Figure 49 Illustrative views of a stabilization tool and tricuspid annulus are shown.

[0057] Figure 50 An isolated illustrative view of a stabilization tool is shown.

[0058] Figure 51 An illustrative view of an anchor deployed at the septal region is shown.

[0059] Figure 52 Another illustrative view of anchors deployed at the septal and posterior regions is shown.

[0060] Figure 53 Another illustrative view of anchors deployed at the septal region, the posterior region, and the first anterior region is shown.

[0061] Figure 54Another illustrative view of a stabilization tool and tricuspid annulus with anchors deployed in all zones is shown.

[0062] Figure 55 An illustrative view of the tricuspid valve is shown.

[0063] Figure 56 Another illustrative view of the tricuspid valve is shown.

[0064] Figure 57-102 Various illustrative views of a stabilization tool are shown. DETAILED DESCRIPTION

[0065] The present disclosure is not limited to the particular systems, devices, and methods described, as these may vary. The terminology used in the specification is for the purpose of describing particular versions or embodiments only and is not intended to limit the scope.

[0066] As used in this document, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. Nothing in this disclosure should be construed as an admission that the embodiments described in this disclosure are not entitled to antedate such disclosure by virtue of prior invention. As used in this document, the term "including" means "including, but not limited to."

[0067] As discussed herein, existing treatments for tricuspid regurgitation are invasive and potentially dangerous. For example, current treatments may include repair methods, such as the DeVega repair and the use of an annuloplasty ring or tricuspid ring that require open-heart surgery. Open-heart surgery may also introduce several comorbidities in addition to any existing conditions. Therefore, many patients with tricuspid regurgitation may not be appropriate candidates for open-heart surgery and would greatly benefit from new devices and / or methods for percutaneous or minimally invasive treatment of tricuspid regurgitation.

[0068] The present invention discloses an implant and delivery system for introducing a semi-rigid ring to treat tricuspid regurgitation, which includes a tricuspid annuloplasty ring comprising an outer hollow member having a plurality of segments. In another embodiment, the segments can be adjustable and can cooperate with each other to change the outer hollow member from an elongated insert molding geometry to an annular operable molding geometry. The tricuspid annuloplasty ring can include one or more zones comprising an internal anchoring member that is at least partially located within the outer hollow member. In one non-limiting embodiment, the tricuspid annuloplasty ring can include up to four different anchoring zones, which are further discussed herein. In one embodiment, the internal anchoring members can be configured to emerge sequentially from the windows (i.e., openings) along the hollow tube, thereby potentially engaging tissue of the tricuspid annulus being treated in a predetermined sequence.

[0069] Various embodiments involving minimally invasive or percutaneous transcatheter delivery of tricuspid valve annulus are disclosed herein. In addition, one embodiment may include a method for reducing or adjusting the size between the anterior and septal leaflets and / or reducing or adjusting the size between the anterior and posterior commissures and the septal leaflets, thereby minimizing or eliminating tricuspid regurgitation problems.

[0070] Thus, systems and methods are provided for introducing the tricuspid valve annulus (e.g., when contained in a linear shape within a delivery system) in a transapical or transfemoral manner. In one embodiment, the distal tip of the delivery system can be introduced above the tricuspid valve annulus. Once introduced into the tricuspid valve annulus, the plane of the tricuspid valve annulus can be rotated (e.g., automatically rotated) to be parallel to the plane of the tricuspid valve annulus.

[0071] The tricuspid annulus can then be snapped into an appropriate shape (e.g., a "D" shape) and introduced into the stabilization tool. This shape is possible because, as discussed herein, the tricuspid annulus includes an outer hollow member having a plurality of segments, wherein the segments can be adjustable and can mate with one another to change the outer hollow member from an annular, operable forming geometry to an elongated, insert forming geometry, and vice versa.

[0072] Once the tricuspid annulus is properly controlled by the stabilization tool (e.g., Figure 38-54 ), a suitably shaped (e.g., "D"-shaped) tricuspid ring can be inserted and guided to a desired location (e.g., the tricuspid valve) within a patient's body. Once in the correct location, an embodiment can deploy multiple anchors. For example, one embodiment can deploy anchors associated with the septal region, the posterior region, or the first or second anterior regions.

[0073] In another embodiment, the anchored tricuspid annulus is anchored toward the septal leaflet, thereby reducing the height of the anterior septal leaflet by approximately 15% to 20%. One or more second anterior region anchors may also be deployed. In another embodiment, the design of the tricuspid annulus may not include anchors in certain regions (e.g., the AV node region). As discussed herein, this may be due to the sensitivity of certain regions to external forces that may lead to adverse effects on the patient, such as arrhythmias, irregular heart rhythms, or heart failure.

[0074] Additionally or alternatively, the tricuspid annulus (eg, septal and posterior regions) may be pulled by a stabilization tool to reduce the height of the anterior-septal leaflet height prior to applying the anchors in the first and second anterior regions.

[0075] The illustrated exemplary embodiments will be best understood with reference to the accompanying drawings.The following description is intended by way of example only and only illustrates certain exemplary embodiments.

[0076] See also Figure 1 , shows a perspective view of a tricuspid valve 100 relevant to various embodiments discussed herein. As shown, the tricuspid valve 100 can have an anterior-septal direction and an anterior-posterior direction of the septal leaflets. In addition, Figure 1 The outline of a normally sized annulus 101 , a dilated annulus 102 , the desired shape of the tricuspid annulus 103 , and the atrioventricular (AV) node 104 are shown. Figure 1 Also shown is the direction of annular repositioning (ie, arrows 105 ) that may be needed to reduce tricuspid regurgitation.

[0077] As will be understood by those skilled in the art, the AV node 104 is part of the heart's electrical conduction system, which coordinates the top of the heart. The AV node 104 is a region of specialized tissue between the atria and ventricles of the heart, specifically in the posterior and inferior region of the atrial septum near the opening of the coronary sinus, that conducts normal electrical impulses from the atria to the ventricles. Puncturing this node or introducing any impulses into this node results in adverse effects such as arrhythmias, irregular heart rhythms, and in the worst case, heart failure. Therefore, in one embodiment, the design of the tricuspid annulus may not include anchors in the section of the annulus that would be positioned adjacent to the AV node.

[0078] exist Figure 2 and 3 , a perspective view of an exemplary embodiment may include a hollow tube 201 / 301, which may be made of various materials (e.g., shape memory hypotube (nickel titanium (Ni-Ti) superelastic alloy)), cut to form a plurality of segments 202 / 302. In one embodiment, the cutouts 203 / 303 in the hollow tube may allow the tube to be used as the outer tube of a segmented tricuspid annuloplasty ring. In addition, Figure 4Shown in further detail are shown for Figure 2 and 3 An illustrative schematic diagram of a cutting pattern for laser machining of a hypotube 401 is shown, eg, the cutting of a window 402 through which an anchor (not shown) may be deployed.

[0079] In one embodiment, Figure 5 As shown in the schematic diagram in FIG, the shape of the memory hypotube 501 is as follows Figure 2 and 3 As discussed and shown, the wave tube may have an operable geometric shape. For example, the wave tube may be annular and / or D-shaped (e.g., Figure 5 ). Additionally, as shown, one embodiment may include a delivery system interface point 502.

[0080] Now see Figure 6 , shows an exemplary laser cutting pattern 600 for laser processing. In one embodiment, the laser cutting pattern 600 can integrate multiple sections (e.g., windows for anchors and specific attachment holes for additional components). In one embodiment, one or more closure features can utilize specific attachment holes to securely connect and close the tricuspid annulus. Thus, as Figure 6 As shown in , an exemplary embodiment may include one or more laser cut patterns 600, one or more laser cut slots 601 for flexibility, one or more windows 602 for anchors, one or more windows 603 for sutures, one or more holes 604 for fabric attachment and fluorinated ethylene propylene (FEP) attachment, one or more holes 605 for suture pins, and one or more snap features 606 for suture pins.

[0081] Fluorinated ethylene propylene, or FEP, is a copolymer of hexafluoropropylene and tetrafluoroethylene (FEP), which differs from polytetrafluoroethylene resin in that it can be melt processed using conventional injection molding and screw extrusion techniques. Additionally, FEP has a very low coefficient of friction, and therefore, in one embodiment, FEP can make an exceptional material for use as an anchor track and / or anchoring the assembly within a laser-cut Ni-Ti ring. FEP offers various benefits over current methods, which require considerable pulling force to retrieve the metal ends of metal rings, especially those with a bend radius, after deployment from a catheter. In contrast, one embodiment can utilize FEP tubing that is laser cut and allows the anchor assembly to slide easily within the laser-cut Ni-Ti ring.

[0082] FEP is very similar in composition to the fluoropolymers PTFE (polytetrafluoroethylene) and PFA (perfluoroalkoxy polymer resin). Both FEP and PFA share PTFE's useful properties of low friction and non-reactivity, but are easier to form. FEP is softer than PTFE and melts at 260°C. It is also highly transparent and sunlight-resistant.

[0083] In some embodiments, the fabric can be secured to cover the tube at the fabric and FEP attachment points 604. The fabric can comprise a variety of materials. In some embodiments, polyester is used to promote tissue ingrowth.

[0084] like Figure 7 As shown in , another embodiment may include a schematic laser cut tube 700. In one embodiment, the schematic laser cut tube 700 configuration may integrate multiple sections (e.g., windows for anchors and specific attachment holes for additional components such as closure features for closing the tricuspid annulus). Thus, as Figure 7 As shown in , an exemplary embodiment may include one or more laser cut slots 701 for flexibility, one or more windows 702 for anchors, one or more windows 703 for sutures, one or more holes 704 for fabric and FEP attachments, one or more holes 705 for suture pins, and an opening feature 706 for suture pins.

[0085] Now see Figure 8 , which shows a perspective view of an exemplary embodiment including a tricuspid annuloplasty ring 800 in which four internal anchor zones are deployed. Specifically, one embodiment can have a first anterior anchoring zone 801, a second anterior anchoring zone 802, a posterior anchoring zone 803, a septal anchoring zone 804, and an AV node zone 805. In some embodiments, the AV node zone can include no anchors.

[0086] Additionally or alternatively, Figure 9 An alternative zone distribution in the tricuspid annulus is shown. In this configuration, the septal zones can overlap to form an improved attachment to the septal annulus. Figure 9 As shown in , an exemplary embodiment may include a tricuspid ring 900 having four anchor regions, an outer ring 901, a first septal region 902, a second septal region 903, a posterior region 904 and an anterior region 905, a snap / closure mechanism 906, and a pivot pin attachment point 907, wherein the pivot pin attachment point is attached to the snap mechanism of the delivery system.

[0087] Now see Figure 10 , shows a perspective view of a laser cut FEP 1001 used as a liner for the inner diameter of a hollow laser cut tube. In one embodiment, the laser cut FEP may include a laser cut anchor deployment window 1002 corresponding to the inner diameter of the hollow segmented tube (i.e., Figure 7 700) on the laser cut window. In addition, as shown in FIG. Figure 11 As shown in , embodiments may include a laser cut pattern 1100 for FEP so that it can properly line the inner diameter of a hollow laser cut tube. Figure 11 As shown in , the laser cut pattern may include laser cut windows 1103 corresponding to the laser cut windows on the hollow segmented tube, where both patterns allow the flexibility of the FEP tube to bend with the outer ring. Figure 11 As shown in , an exemplary embodiment may include laser cutting FEP 1100, allowing flexible material release 1101, one or more corresponding holes 1102 for sutures and encoding the FEP to the collar, and one or more corresponding windows 1103 for anchors.

[0088] Figure 12 An alternative perspective view of an embodiment comprising laser cut FEP in its tubular configuration 1200 is shown. As shown, the laser cut FEP 1200 can provide a lining for the inner diameter of the hollow laser cut tube and contain one or more laser cut windows 1203 corresponding to the one or more laser cut windows on the hollow segmented tube, as discussed herein. Another embodiment can have a pattern that allows the FEP tube 1200 to be flexible and bend with the outer ring, such as Figure 12 The pattern shown in . Figure 12 As shown in , one embodiment may include laser cutting of FEP 1200, allowing flexible material release 1201, one or more corresponding holes 1202 for sutures and encoding of the FEP to the tricuspid annulus, and one or more corresponding windows 1203 for anchors.

[0089] See also Figure 13-16 , shows an embodiment showing the geometry and views of four anchor rails. For example, Figure 13 An anchor rail for the septal region of the tricuspid annulus is shown, and Figure 14 Anchor rails for the posterior leaflet are shown. Figure 15 and 16 Two anchor rails are shown, each designed to anchor the tricuspid annulus to the anterior segment of the tricuspid valve (eg, regions A and B of the anterior segment).

[0090] like Figure 17 As shown, another embodiment may have an anchor system for the posterior / anterior regions. As a non-limiting example, such as Figure 17The exemplary embodiment shown in FIG. 1 may include an anchoring region 1700 , a harpoon 1702 , a harpoon barb 1703 , an anchor stop (AS) feature 1704 , an anchoring region rail 1706 , an anchoring region deployment hole 1719 , and a loading hole 1720 .

[0091] As discussed herein, various embodiments may employ anchor stops (e.g., 1704). The need for anchor stops arises from the fact that the anchors may move and assume a "D" shape after deployment of the tricuspid annulus from a catheter (e.g., in a linear shape), as discussed herein. Specifically, an anchor assembly that is held stationary while the annulus is held in a linear position (e.g., an anchor held below and adjacent to a window in a laser-cut tube) may begin to prematurely move from the window and become dislodged due to the curvature radius of the annulus.

[0092] Therefore, to prevent premature deployment (which can render the ring useless and cause serious problems during surgery), one embodiment utilizes anchor stops to hold the anchors in place until the ring has reached its final position and deployment is appropriate. In the methods discussed herein, once the assembly has reached its final position, the anchor stops can be overcome as the operator pulls on the suture connected to the anchor assembly and forces the assembly and its stops to slide, thereby deploying the anchor system. Generally speaking, the anchor stops are raised block geometric features or steps that prevent the anchor assembly from moving out of the delivery system when the ring is deployed; however, various embodiments and configurations are discussed herein and shown in the corresponding figures.

[0093] exist Figure 18 In another embodiment shown, a laser cut pattern can be used in the septal region. Figure 18 As shown in FIG, an embodiment may include an anchoring region 1800, a harpoon member 1801, a harpoon member barb 1802, an anchor member stop (AS) feature 1803, an anchoring region rail 1804, an anchoring region deployment hole 1819, and a stowage region 1820. Additional details regarding the harpoon member 1801 are provided in FIG. Figure 19 As shown in Figure 19 As shown in the embodiment of FIG, the harpoon member 1801 may have one or more harpoon member barbs 1902. Additional details about the anchor member stop feature 1803 are provided in FIG. Figure 20 As shown in Figure 20 As shown in the embodiment of FIG, the anchor stop feature 1803 may include a first connecting strut 2011, a second connecting strut 2012, a deployment angle 2013, and an anchor stop feature height 2014.

[0094] Additionally or alternatively, Figure 21As shown in FIG, an embodiment may include an anchor stop feature 1803 that is attached with a strut to an anchoring region having a negative deployment angle 2113. In another embodiment, the anchor stop feature 1803 may include one or more deployment holes 2115. Thus, as Figure 21 As shown, embodiments may include a typical anchor stop feature 1803 , a first connecting strut 2111 , a deployment angle 2113 , an anchor stop feature height 2114 , an anchor stop deployment hole 2115 , and an anchor region suture routing hole 2118 .

[0095] Figure 22 Another exemplary embodiment of an anchor stop feature 1803 is shown. As shown, the anchor stop feature 1803 may include a first connecting strut 2211, a second connecting strut 2212, a deployment angle 2213, and an anchor stop feature height 2214. Additionally or alternatively, as Figure 23 As shown in , embodiments may include an anchor stop feature 1803 having a weak point 2216 to guide the anchor stop to break at a certain point. Figure 23 As shown in , an embodiment can include a first connecting strut 2311, a deployment angle 2313, an anchor stop feature height 2314, an anchor stop deployment hole 2315, and an anchor stop feature strut weakness 2316.

[0096] Now see Figure 24 , embodiments may include active anchor stop features with activation holes 2417 on the anchor zone rails. Thus, as Figure 24 As shown in , the illustrated embodiment may include a first connecting strut 2411, a deployment angle 2413, an anchor stop feature deployment hole 2415, a start hole 2417 for changing the suture direction from horizontal to vertical, an anchor area suture routing hole 2418 and an anchor area deployment hole 2419.

[0097] The anchor stop can be used to position the anchoring region relative to the hypotube and act as a locking feature to prevent accidental movement and activation of the anchoring region. In some embodiments, this feature can be passive and can be activated by pulling and thereby bending the region. In other embodiments, the feature can be an activation pulley that prevents the anchoring region from bending and moving away from the hypotube. In some embodiments, the anchor stop is located on the ventricular side of the anchoring region. In other embodiments, the anchor stop is located on the atrial side of the anchoring region.

[0098] As discussed herein, embodiments may take the shape of a memory hypotube and may have operable geometries such as annular and / or D-shaped geometries (e.g., Figure 5 Now see Figure 25, shows a perspective view of an illustrative distal end of a delivery system 2501 having an implant interface member coupled to the tricuspid annulus 2502.

[0099] Figure 26 and 27 A general view of one or more typical anchors is shown in an initial position and a deployed position, respectively. Figure 26 In FIG, anchors 2601 are inserted into hollow laser-cut tubes 2602 below their respective deployment windows. Figure 27 , the non-limiting example shows a deployed anchor 2701 after it has been deployed from its corresponding deployment window 2702. Further details of the deployed anchor 2701 are shown in FIG. Figure 28 , which shows a deployment window 2802 (see also Figure 6 602) and an enlarged view of a segment of the tricuspid annulus 2803 with the anchor 2801 deployed.

[0100] Now see Figure 29 , the embodiment shown includes the initial geometry of the tricuspid annulus when deployed from the delivery system (as shown in solid lines) and the geometry of the tricuspid annulus after all anchors are deployed (as shown in dashed lines). In some embodiments, the tricuspid annulus can include a first anterior region, a second anterior region, a posterior region, and a septal region. Thus, as shown in FIG. Figure 29 As shown in , the solid line may illustrate the initially deployed geometry, while the dashed line may illustrate one possible final geometry after the anterior leaflet (eg, at zone 2) has been diverted to reduce the anterior septal height.

[0101] Figure 30 A perspective view of an embodiment in which a tricuspid ring 3000 can include one or more snap mechanisms 3001 connecting the proximal and distal ends of a laser-cut hollow tube to form a geometric shape (e.g., a "D" shape) is shown. In another embodiment, the geometrically shaped tricuspid ring can include one or more anchors 3002 deployable from a deployment window 3003.

[0102] Figure 31 A perspective view of an embodiment in which the tricuspid ring 3100 includes a snap-fit ​​mechanism 3105 that connects to a laser-cut hollow tube ( Figure 7 The proximal and distal ends of the tricuspid annulus 700 are formed to mimic the natural shape of the tricuspid annulus. In another embodiment, the tricuspid annulus 3100 may further include one or more anchors deployed from one or more deployment windows. In one embodiment, as Figure 31 As shown in , the anchor can exit the deployment window at an angle ranging from about 30 degrees to about 75 degrees from the horizontal plane.

[0103] Therefore, if Figure 31 As shown in , one embodiment may include: a tricuspid valve ring 3100; an anterior region 3101, wherein the anchor member leaves the tricuspid valve ring at a certain angle to provide anchoring force in the radial direction and the axial direction; a posterior region 3102, wherein the anchor member leaves the tricuspid valve ring at a certain angle to provide anchoring force in the radial direction and the axial direction; a first septum region 3103, wherein the anchor member leaves the ring at a certain angle to provide anchoring force in the radial direction and the axial direction; a second septum region 3104, wherein the anchor member leaves the ring at a certain angle to provide anchoring force in the radial direction and the axial direction; a snap mechanism (e.g., a closing mechanism) 3105; and a suture pin 3106 for providing a rotation pin for the suture.

[0104] Figure 32 A perspective view of an embodiment is shown in which the tricuspid annulus is secured in a closed configuration using a snap mechanism 3200. Figure 32 As shown in the , an embodiment may include a snap mechanism 3200, a suture pin (e.g., attachment of the female and male parts of the ring tube) 3201, a female part 3202 of the snap mechanism, a pivot pin (e.g., attaching the snap mechanism to the delivery system with a safety line) 3203, a cover part (e.g., a part for retaining the nitinol disc that snaps the male part into the female part) 3204, and a male part 3205 of the snap mechanism.

[0105] Figure 33 Detailed views of one embodiment are shown in which the snap mechanism 3300 is in an open configuration. Again, similar to the embodiments discussed herein, the snap mechanism 3300 is used to secure the tricuspid annulus in a closed configuration. Thus, as Figure 33 As shown in , one embodiment may include a snap mechanism 3300, a female component 3301 of the snap mechanism, a pivot pin (e.g., a safety line for attaching the snap mechanism to the delivery system) 3302, a cover component (e.g., a component for retaining the nitinol disc that snaps the male component into the female component) 3303, a cup (e.g., the interface between the female component and the ring tube) 3304, and a male component 3305 of the snap mechanism.

[0106] Figure 34 A detailed view of an embodiment of the snap mechanism in the closed configuration is shown in FIG. Similar to the embodiments discussed herein, the snap mechanism 3400 is used to secure the tricuspid annulus in the closed configuration. Thus, as Figure 34 As shown in , one embodiment may include a snap mechanism 3400, a female component 3401 of the snap mechanism, a pivot pin (e.g., a safety line for attaching the snap mechanism to the delivery system) 3402, a cover component (e.g., a component for retaining the nitinol disc that snaps the male component into the female component) 3403, a cup (e.g., the interface between the female component and the ring tube) 3404, and a male component 3405 of the snap mechanism.

[0107] Figure 35 A detailed view of the female component 3401 of the snap mechanism 3400 according to one embodiment is shown in FIG. Figure 35 As shown in the figure, the female part 3401 of the snap mechanism 3400 may include a pivot pin (e.g., attaching the snap mechanism to the delivery system with a safety line) 3502, a cup (e.g., the interface between the female part and the ring tube) 3503, a nitinol disk 3504 for locking the snap into position, a window 3505 for suture routing, a window 3506 for suture pins, and a gold marker 3507.

[0108] Figure 36 An exemplary cross section of the female component 3401 of the snap mechanism 3400 is shown according to one embodiment. Figure 36 As shown in the figure, the female component 3401 of the snap mechanism 3400 may include a pivot pin (e.g., a safety line to attach the snap mechanism to the delivery system) (not shown), a cover 3602 to hold a nickel titanium (Ni-Ti) disc, a cup (e.g., the interface between the female component and the ring tube) 3603, a nitinol disc for locking the snap into position (the tongue can only be opened in one direction to prevent accidental unfastening) 3604, a window 3605 for suture routing, and a window 3606 for suture pins.

[0109] Figure 37 A detailed view of the male component 3405 of the snap mechanism according to one embodiment is shown in FIG. Figure 37 As shown in the figure, the male part 3405 of the snap mechanism 3400 may include a male cone 3701 (to allow the male part to smoothly enter the female part and lock within the female part), at least one window 3702 for suture routing, at least one window 3703 for a suture pin, and at least one protrusion 3704 located on the suture pin.

[0110] Now go to Figure 38 , shows a detailed view of the distal end of the delivery system 3800. In one embodiment, the distal end of the delivery system 3800 can interface with the tricuspid annulus assembly. For example, Figure 39 A detailed view of the distal end 3901 of the delivery system 3900 is shown, where the delivery system interfaces with the tricuspid annulus assembly and the tricuspid annulus 3950 .

[0111] like Figure 39As shown in FIG, a delivery system 3900 can interface with a tricuspid annulus 3950 that can have an anterior region 3951 in which the anchors are angled away from the annulus to provide anchoring forces in both radial and axial directions. The tricuspid annulus 3950 can also have a posterior region 3952 in which the anchors are angled away from the annulus to provide anchoring forces in both radial and axial directions, a snap mechanism (e.g., a closure mechanism) 3953, and a suture pin 3954 for providing a rotational pin for the suture. The delivery system 3900 can include a distal end 3901 of a guide catheter, a stabilization mechanism 3902 to ensure annulus stability during the implantation procedure, a delivery system (DS) tongue (e.g., annulus interface device) 3903, and a stabilization tool 3904.

[0112] Figures 40-42 Various views of the delivery system are shown during initial deployment of the tricuspid annulus by the delivery system. In one embodiment, and as Figure 40 As shown in FIG, the tricuspid annulus 4001 can exit the delivery system 4002 in a linear shape. Once the tricuspid annulus 4001 exits the delivery system, the methods disclosed herein can be used in some embodiments and as shown in FIG. Figure 41 and 42 It is formed into a ring shape by the method shown in . Figure 41 An embodiment of molding a tricuspid annulus 4101 using a delivery system 4102 is shown. In some embodiments, and as Figure 41 As shown in FIG, the tricuspid annulus 4101 can be angled between about 30° and about 40° from a plane perpendicular to the delivery system 4102. Figure 42 An embodiment is shown in which the tricuspid ring 4201 is formed and a snap mechanism (e.g., a closure mechanism) 4203 secures the ring in the appropriate geometry. In some embodiments, such as Figure 42 As shown in , a delivery system 4202 can be used to move or modify the shape or position of the tricuspid annulus 4201.

[0113] In some embodiments, such as Figure 43 As shown in the figure, the delivery system 4300 can be interfaced with the tricuspid annulus 4350. The tricuspid annulus 4350 can also have a posterior region (in which the anchor member is angled away from the tricuspid annulus (not shown) to provide anchoring force in the radial and axial directions), a snap mechanism (e.g., a closure mechanism) (not shown), and a suture pin (not shown) for providing a rotation pin for the suture. The delivery system 4300 can include a distal end of a guide catheter (not shown), a stabilization mechanism 4301 to ensure annulus stability during the implantation procedure, a delivery system (DS) tongue (e.g., annulus interface device) (not shown), and a stabilization tool 4302. As shown, after rotation about the hinge, the plane of the tricuspid annulus 4350 can be removed from the plane of the tricuspid valve between about 0° and about 40°.

[0114] In another embodiment, Figure 44 As shown in , after rotation about the hinge, the plane of the ring can be parallel to or slightly angled (e.g., about 0° to about 40°) with the plane of the tricuspid valve. Thus, one embodiment can utilize a transapical approach (i.e., pulling the ring to the tissue). In some embodiments, the delivery system 4400 can interface with a tricuspid ring 4450, which can have an anterior region, wherein anchors (not shown) leave the ring at an angle to provide anchoring forces in radial and axial directions. The tricuspid ring 4450 can also have a posterior region 4403 (wherein the anchors leave the tricuspid ring at an angle to provide anchoring forces in radial and axial directions), a snap mechanism (e.g., a closure mechanism) (not shown), and a suture pin (not shown) for providing a rotation pin for the suture. The delivery system 4400 can include a distal end 4401 of a guide catheter, a stabilizing mechanism 4402 to ensure ring stability during the implantation procedure, a delivery system (DS) tongue (e.g., a ring interface device) (not shown), and a stabilizing tool 4404. As described above, the ring orientation relative to the delivery system 4400 can be in the range of about 0 degrees to about 40 degrees "above" the horizontal plane. As discussed herein, the approach is transapical, thereby pulling the ring to the tissue. In another embodiment, the ring orientation can be in the range of about 0 degrees to about 40 degrees "above" the horizontal plane of the delivery system. Figure 44 Shown is a deployed anchor Figure 43 implementation plan.

[0115] In another embodiment, Figure 45 As shown in , after rotating about the hinge, the tricuspid annulus can be positioned parallel to or below the plane of the tricuspid valve. Again, this approach is transapical, pulling the annulus to the tissue. However, Figure 45 Different from Figures 43-44 In embodiments of the present invention, the ring orientation relative to the delivery system can be in the range of about 0 degrees to about 40 degrees "below" the horizontal plane. In additional embodiments, such as Figure 45 As shown in , the position of the tricuspid valve ring after rotation about the hinge can be parallel to or slightly below the plane of the tricuspid valve. In this embodiment, the ring orientation relative to the delivery system can be in the range of about 0 degrees to about 40 degrees "below" the horizontal plane. Figure 46 An embodiment is shown with anchors deployed.

[0116] like Figures 45-46As shown in , in some embodiments, the delivery system 4500 can interface with a tricuspid annulus 4550 which can have an anterior region in which anchors (not shown) are angled away from the annulus to provide anchoring forces in radial and axial directions. The tricuspid annulus 4550 can also have a posterior region in which anchors are angled away from the tricuspid annulus to provide anchoring forces in radial and axial directions, a snap mechanism (e.g., a closure mechanism) (not shown), and a suture pin (not shown) for providing a rotation pin for the suture. The delivery system 4500 can include a distal end 4501 of a guide catheter, a stabilizing mechanism 4502 to ensure annulus stability during the implantation procedure, a delivery system (DS) tongue (e.g., annulus interface device) (not shown), and a stabilizing tool 4504.

[0117] Figure 47 An enlarged view of the tricuspid annulus 4750 is shown after rotation about the hinge so that the plane of the annulus can be parallel to the plane of the tricuspid valve. The method can be transatrial, transseptal, and / or transcervical, thereby pulling the annulus to the tissue. In one embodiment, as Figure 47 As shown in , the ring orientation relative to the delivery system can range from about 0 degrees to about 40 degrees "below" the horizontal plane, and the anchor 4751 can be deployed or not.

[0118] Additionally or alternatively, Figure 48 An enlarged view of the tricuspid annulus 4850 is shown after rotation about the hinge, whereby the plane of the annulus is parallel to the plane of the tricuspid valve. Figure 48 The method can also be transatrial, transseptal and / or transcervical, thereby pulling the ring to the tissue. In another embodiment, as Figure 48 As shown in , the ring orientation relative to the delivery system can range from about 0 degrees to about 40 degrees "above" the horizontal plane, and the anchors may or may not be deployed.

[0119] Now see Figures 49-50 , one embodiment shows the geometry of a stabilizing tool that may be needed to position the tricuspid annulus 4901 above the annulus. As a non-limiting example, Figure 49 The tricuspid annulus 4901, which may include multiple zones, and its interaction with a stabilization tool 4902 are shown. In one embodiment, the stabilization tool 4902 may be coupled to or attached to a delivery system 4903, such as Figure 49 A more detailed view of the stabilization tool is shown in Figure 50 In some embodiments, the stabilization tool 5002 can be made of superelastic nickel titanium (Ni-Ti) from a laser cut hypotube.

[0120] Figures 51-54 An exemplary ring is shown as it is placed in the annulus, and the anchor is deployed into the tricuspid annulus. Specifically, Figure 51 Deployment of a septal anchor into the septal segment of the tricuspid annulus adjacent to the septal leaflets is shown. Figure 52 Deployment of the posterior anchor into the posterior segment of the annulus adjacent to the posterior leaflet is shown. Figure 53 Additional deployment of the first region of the anterior anchor adjacent to the anterior leaflet is shown. Figure 54 Dragging of the anterior leaflet (eg, by a stabilization tool) is shown as a means of reducing dilation of the annulus and thereby improving coaptation of the anterior and septal leaflets.

[0121] Figures 55-56 Other exemplary embodiments of the tricuspid valve 5500 / 5600 are shown. Figure 55 It should be understood that the tricuspid valve 5500 may include: anterior septal commissure 5501, septal leaflet 5502, anterior and posterior commissure 5503, anterior leaflet 5504, posterior septal commissure 5505, valve annulus 5506, coronary sinus 5507 and AV node 5508. Figure 56 , the annulus of the tricuspid valve 5600 can be expanded. For clarity, the expanded annulus shape 5601 is shown next to a standard-sized annulus (i.e., the desired shape of the tricuspid annulus) 5602 (dashed line) as a non-limiting example. The tricuspid valve 5600 can also include an AV node 5608.

[0122] As will be appreciated by those skilled in the art, various methods for mitral valve repair systems are discussed herein. In some embodiments, a delivery system and annuloplasty ring can be minimally invasively implanted into a person's mitral valve annulus using a transapical or transseptal approach. Furthermore, described herein in detail are methods and tools for delivering a system having an annuloplasty ring with an anchor for transapical introduction into the mitral valve annulus.

[0123] If multiple graphs (e.g. Figure 39 ), in some embodiments, the position of the annuloplasty ring can be controlled (e.g., angle of inclination and formation of close contact with tissue to facilitate deployment of anchors) due to a variety of stabilization mechanisms or tools (e.g., 3904). In some embodiments, the stabilization tool can be made of a tubular Ni-Ti structure. In some embodiments, the structure can have multiple prongs (e.g., Figure 39 , two prongs) that are designed to engage the annuloplasty ring, control its tilt, and control movement to achieve anterior-posterior repositioning after the posterior portion of the annulus is anchored to the ring and before the anterior portion of the ring is anchored. In various embodiments discussed above, the stabilization tool can be a rigid element housed within one or more lumens of the delivery system.

[0124] Using the system disclosed above, once the ring is deployed (e.g., ejected from the delivery system) and has been placed in an operable geometry (e.g., a "D" shape), the stabilization tool can be pushed through at least one inner lumen of the delivery system and deployed adjacent to and / or over the ring. The stabilization tool can then be positioned using fluoroscopic guidance to position the tip (e.g., Figure 39 2 prongs shown) engage with the ring.

[0125] While the aforementioned stabilization tools are effective and functional during a transapical approach, they can have limitations when the procedure needs to be performed via a transseptal approach. This limitation is due to the rigid nature of the stabilization tools, both permanently housed within the delivery system and the tines. The rigidity of the stabilization tools limits their ability to exert push and pull motions on the annuloplasty ring during placement.

[0126] Thus, an alternative, more flexible stabilization mechanism is disclosed herein that is effective and functional in both the transapical and transseptal aspects. Figures 57-59 , shows a perspective view of the distal portion of a mitral valve repair system according to some embodiments. It should be noted that the drawings are for illustrative purposes only, and various other embodiments may be present and described herein. In particular, the systems and methods may also be applicable to tricuspid valve repair. Figure 57 As shown in , in some embodiments, the system may have an outer catheter 1, an inner catheter 2, an annuloplasty ring (e.g., after deployment and in a "D" shape) 3, a stabilization mechanism (i.e., an adjustment tool) 4, a connector (e.g., a suture connector) 5, a surface (e.g., a Dracon surface) 6, one or more sutures 7, an articulated connection 8, one or more anchors 9, and one or more sewing rings 10.

[0127] like Figure 57 As shown in , some embodiments of the stabilization mechanism 4 can comprise a nitinol (Ni-Ti) wire having an outer diameter between about 0.015 mm and about 0.030 mm. In another embodiment, the stabilization mechanism 4 can be about 4 meters in length, or any length that allows for proper manipulation of the annuloplasty ring disclosed herein. In other embodiments, the stabilization mechanism 4 can be heat treated to form a shape that can be forcibly transferred to the annuloplasty ring 3 at one or more desired locations.

[0128] It should be understood that the stabilization mechanism (e.g., wire) 4 can have various diameters and / or varying diameters along its length. For example, in some embodiments, the stabilization mechanism 4 can have a larger diameter within the catheter (e.g., a straight segment of the catheter) 1 or 2 to allow the stabilization mechanism to withstand larger push and pull forces to facilitate transmission. In additional embodiments, the stabilization mechanism 4 can have a smaller or gradually decreasing diameter within the curved portion of the inner catheter 2 or outer catheter 1 (e.g., a proximal segment of the stabilization mechanism) to create less catheter stiffness in the curved area of ​​the system. In addition, other diameters can be used in various portions of the stabilization mechanism 4 (e.g., the segment that exits the catheter tip and interacts with the annuloplasty ring). Thus, in some embodiments, the various diameters allow the stabilization mechanism 4 to provide optimal push and pull force transmission to the annuloplasty ring without prolapse.

[0129] In other embodiments, the stabilization mechanism 4 can be pulled or ground (e.g., with an oval or rectangular cross-section) to provide greater push and pull force transmission to the desired segment. One or more embodiments can also have an intermediate segment. The intermediate segment of the stabilization mechanism 4 can be welded with two (2) connectors 5, which can then be sewn or inserted into the fabric of the annuloplasty ring 3, see (e.g.) Figure 58 This connection creates a strong yet removable connection between the stabilization mechanism 4 and the annuloplasty ring.

[0130] In some embodiments, the stabilizing tool 4 may have two distinct parts. Figure 57 As shown in FIG, the stabilization mechanism 4 can have a first portion 4A and a second portion 4B that can be received in the inner catheter 2. In another embodiment, the inner catheter 2 can have two separate dedicated lumens (not shown), wherein the first portion 4A and the second portion 4B can each be received in a separate dedicated lumen. Thus, in various embodiments, one or more proximal ends of the stabilization mechanism 4 (e.g., 4A and 4B) can extend from the proximal end of the inner catheter 2 received in the proximal handle.

[0131] In one or more embodiments, the stabilization mechanism 4 can provide the ability to control the tilt angle of the annuloplasty ring 3 about the hinged connection 8. As shown, and in some embodiments, the hinged connection 8 can be located at the connection point between the annuloplasty ring 3 and the inner catheter 2. As discussed herein, the tilt angle of the annuloplasty ring 3 can be adjusted by pushing and / or pulling the proximal ends of the first portion 4A and / or the second portion 4B simultaneously or individually.

[0132] Now see Figure 60In some embodiments, the initial tilt angle of the annuloplasty ring 3 can be α relative to the inner catheter 2. In another embodiment, if it is desired to tilt the anterior segment of the ring in a uniform manner (i.e., to reduce the angle α to a smaller angle β), the operator can pull the first portion 4A and the second portion 4B simultaneously within the proximal handle (e.g., using an additional mechanism to smoothly pull and / or push).

[0133] It will be appreciated that when the operator pulls on the first and second parts 4A, 4B simultaneously, this will cause a biasing force to be applied to one or more connection points 5, such as Figure 57 and Figure 58 As shown in , the annuloplasty ring 3 is rotated about the hinge connection 8. The rotation of the annuloplasty ring 3 about the hinge connection 8 causes the ring tilt angle to decrease from α to β, as shown in Figure 60 shown.

[0134] In additional embodiments, (i.e., where non-uniform tilting of the annuloplasty ring 3 is desired), the first portion 4A may be fixed and the second portion 4B may be biased in one or more directions, thereby causing the annuloplasty ring to tilt in a single direction (e.g., toward the second portion 4B). In alternative embodiments, (i.e., where non-uniform tilting of the annuloplasty ring 3 is desired), the second portion 4B may be fixed and the first portion 4A may be biased in one or more directions, thereby causing the annuloplasty ring to tilt in a single direction (e.g., toward the first portion 4A).

[0135] In some embodiments, during mitral valve repair surgery, the deployment of the stabilization mechanism 4 can be performed before the deployment of the anchor 9 (e.g., Figure 61 ) or after in the posterior segment of the ring.

[0136] Thus, in some embodiments, the annuloplasty ring 3 can be deployed out of the outer catheter 1 in an elongated geometry. In another embodiment, the "D"-shaped geometry can then be achieved by manipulating the annuloplasty ring 3 using one or more steering mechanisms (not shown) in the outer catheter 1 and / or the inner catheter 2, as described herein. Thus, in one or more embodiments, using the techniques described herein, intimate contact and desired placement of the annuloplasty ring 3 and thereby intimate contact and desired placement of one or more anchors 9 (e.g., on the posterior side of the annuloplasty ring) can be achieved to allow for proper deployment of the anchors.

[0137] Once the posterior side of the annuloplasty ring 3 is properly anchored, further manipulation of the annuloplasty ring 3 can be achieved. For example, it may be desirable to drag or move the anterior side of the annuloplasty ring 3 to the anterior side of the annulus. Thus, in some embodiments, the annuloplasty ring 3 may be positioned to the anterior side of the annuloplasty ring 3. Figure 61The stabilizing mechanism 4 shown in controls the tilt angle of the annuloplasty ring 3. It should be understood that this is a non-limiting example and that the annuloplasty ring 3 may be properly anchored on the anterior side and may need to be moved relative to the posterior side of the annuloplasty ring.

[0138] In another embodiment, the stabilization mechanism 4 can control not only the tilt angle of the annuloplasty ring 3, but also the intimate contact between the annuloplasty ring 3 and the annulus. For example, once the optimal tilt angle of the annuloplasty ring 3 has been achieved, initial contact with the anterior portion of the annulus can be established and verified by echocardiography. Once verified, the stabilization mechanism 4 can remain engaged to stabilize intimate contact between the annuloplasty ring 3 and the annulus during deployment of the anchor 9 in the anterior portion of the annuloplasty ring.

[0139] After the one or more anterior anchors 9 have been successfully deployed and the anchoring process has been completed, the stabilization mechanism 4 can be released from the annuloplasty ring 3. In one embodiment, the removal of the stabilization mechanism 4 can be achieved by applying a biasing force (e.g., pulling) on ​​one end of the stabilization mechanism (e.g., the first portion 4A or the second portion 4B). This is possible because, in some embodiments, the stabilization mechanism 4 can be passed through a Dacron covering (e.g., a Dacron covering an outer portion of the annuloplasty ring 3, such as Figure 58 In another embodiment, the stabilizing mechanism 4 can be released from the Dacron fabric by applying a biasing force (e.g., pulling) on ​​the stabilizing mechanism to remove it from the sewing ring 10 attached to the Dacron cover, as shown in FIG. Figure 59 Once the stabilizing mechanism 4 is completely removed from the sewing ring 10, it can be retracted through the end of the inner catheter 2 and pulled out of the proximal handle.

[0140] Now see Figure 62 , shows an embodiment with an annuloplasty ring 3 connected to an inner catheter 2. According to some embodiments, one or more hypotubes 11 may exit from the inner catheter 2. Figure 62 As shown in the illustrative example of FIG, two hypotubes 11 may exit the inner catheter 2. In some embodiments, the hypotubes 11 may extend in / through (e.g., be housed within) a separate lumen (not shown) within the inner catheter 2. In another embodiment, and as Figure 62 As shown in FIG, one or more hypotubes 11 can accommodate the stabilization mechanism 4 (e.g., the first portion 4A and the second portion 4B). In some embodiments, the hypotube 11 can be constructed of Ni-TI, stainless steel, a polymer (e.g., reinforced polyamide), etc. In additional embodiments, the inner diameter can be in the range of about 0.020 inches to about 0.038 inches, and can have an ID that can be in the range of about 0.012 inches to about 0.022 inches.

[0141] Now see Figure 63 and 64 , shows a distal segment of a transapical system 100 according to one or more embodiments. The system 100 can have an annuloplasty ring 101 , a stabilization mechanism (ie, adjustment tool) 102 , and a delivery system interface (eg, articulating connection) 103 . Figure 63 and 64 A guide wire 104 is also provided to indicate the horizontal orientation of the annuloplasty ring 101. Figure 63 An embodiment is shown in which a negative angle exists between the annuloplasty ring 101 and the horizontal guide wire 104. Alternatively, Figure 64 An embodiment is shown in which there is a positive angle between the annuloplasty ring 101 and the horizontal guide wire 104. Thus, as shown by Figure 63 and 64 As will be appreciated, the stabilization mechanism 102 can control the angle of the annuloplasty ring 101 relative to the annulus to and from a negative angle (e.g., Figure 63 ) to a positive angle (e.g., Figure 64 ).

[0142] Figure 65 and 66 An embodiment of the distal segment of a transseptal approach 100 is shown. Similar to the transapical approach, the annuloplasty ring 101 can be controlled by a stabilizing mechanism (ie, adjustment tool) 102 to achieve positive angles (eg, Figure 65 ) and / or negative angles (e.g. Figure 66 ).

[0143] Go to Figure 67 , shows an exemplary embodiment of the distal end of the stabilizing mechanism 102. In some embodiments, the stabilizing mechanism 102 can be mechanically cut, laser cut, and / or heat treated into any shape. One skilled in the art will appreciate that this can include adding a hole at the distal end that can be used to form an attachment to the annuloplasty ring 101. In another embodiment, the stabilizing mechanism 102 can be constructed from one or more pieces (e.g., 1, 2, 3, ... n wires or cables as discussed herein). Thus, the stabilizing mechanism 102 can be constructed from any material or combination of materials to provide the desired geometry and attachment to the distal end of the annuloplasty ring 101.

[0144] like Figure 68 In some embodiments, the stabilizing mechanism 102 can be constructed from a single wire that is formed into a desired shape at the distal end with or without heat treatment / setting. In another embodiment, the wire is advanced through a catheter into the proximal side of the delivery system. In some embodiments, and as shown in FIG. Figure 68, the stabilization mechanism 102 can have an anterior portion 116 designed to support the anterior portion of the annuloplasty ring 101. In another embodiment, the stabilization mechanism 102 can include a bend radius region 117 in or near the commissure region, a bend radius region 118 in or near the plane of the annuloplasty ring 101, and a bend radius region 119 at or near the posterior side of the annuloplasty ring.

[0145] As discussed herein, the stabilization mechanism 102 can be constructed of various materials and have various sizes, such as, for example, a wire shape can be constructed of stainless steel, steel, and / or a memory shape material (e.g., Nitinol) and can have a diameter of about 0.2 mm to about 2 mm. The stabilization mechanism 102 can vary in size and diameter (e.g., reduced to allow for greater flexibility and / or enlarged to increase stiffness and support).

[0146] Now see Figure 69 and 70 , shows an exemplary embodiment showing the different shapes that the stabilizing mechanism 102 can assume by manipulating the front 116 and two bend radii (e.g., 117 and 119). Additional exemplary embodiments are shown in Figure 71 and 72 , where the front portion 116 of the stabilizing mechanism 102 can influence the shape of the annuloplasty ring 101 via the bend radii 117 and 119. As shown, Figure 72 An embodiment is shown in which the support follows the entire circumference of the annuloplasty ring 101. In contrast, Figure 71 A possible alternative system is shown in which the stabilization mechanism 102 contacts only the anterior portion of the annuloplasty ring.

[0147] like Figure 73 and 74 As shown in , the angle α and radius can be modified. In some embodiments, the angle can range from about 45° to about 180°, and the radius can vary from about 2 mm to about 30 mm. In some embodiments, modifying the angle and radius can affect the push / pull capability and the elongation of the stabilization mechanism 102.

[0148] See also Figures 75-78 As shown, some embodiments may include a stabilizing mechanism (e.g., a wire) 102, a pull attachment subassembly 200, a docking post 201, a docking post anchor 202, a deactivation wire 210, an opening 203 for the deactivation wire, and an opening 204 in the docking post anchor for attaching the stabilizing mechanism. Figure 75 and 76 As shown in , one embodiment may include a docking post 202 for the stabilization mechanism 102 .

[0149] like Figure 75, the attachment feature 200 can be comprised of two separate components: a docking post 201, which can be attached to an annuloplasty ring (not shown) using any of the various methods disclosed herein (e.g., suturing to the tubing itself and / or suturing to the fabric covering the ring body); and a docking post anchor 202, which can be comprised of metal or plastic (e.g., polyethylene, polypropylene, and PVC). In some embodiments, the docking post anchor 202 can be attached to the stabilization mechanism 102 using various means (e.g., adhesives, welding, sutures, etc.). Figure 75 and 77 is an exemplary embodiment of the attachment feature 200 without the stabilization mechanism 102 attached. Alternatively, Figure 76 and 78 Shown is the stabilizing mechanism 102 attached to the attachment feature 200 .

[0150] Separation of the stabilizing mechanism 102 from the attachment feature 200 can occur in a variety of ways. In some embodiments, a region can be prepared so that it breaks at a certain point in response to a specific force level or a specific movement. In other embodiments, a separate component can serve as a deactivation feature, such as, for example, a deactivation line. In another embodiment, separation can occur in response to the suture being pulled (e.g., by a user), resulting in release of the attachment. Figure 77 and 78 As shown in , the attachment can be separated using a deactivation line 210. Thus, in some embodiments, the hole 203 for the deactivation line can be used to secure the stabilization mechanism 102. It should be understood that the foregoing is merely exemplary and that other means of separation may exist.

[0151] Now see Figures 79-81 , shows an embodiment including an annuloplasty ring 101, a stabilization mechanism 102, a docking post 201, and a deactivation wire 210. As shown, the stabilization mechanism 102 can include multiple wires and can be attached to the annuloplasty ring 101 via the docking post 201 using the deactivation wire 210. In some embodiments, the deactivation wire 210 can follow substantially the same path as the stabilization mechanism 102. Alternatively, the deactivation wire 210 can follow a different path than the stabilization mechanism 102 based on situational requirements (e.g., the amount of force to be transmitted to the annuloplasty ring 101).

[0152] If a significant amount of force must be transferred or applied to the annuloplasty ring 101, it may be beneficial for the deactivation line 210 to follow the path of the stabilization mechanism 102. In embodiments where it is desired to counteract the force (i.e., not apply it to the annuloplasty ring 101), the stabilization mechanism 102 may pass through the annuloplasty ring's attachment mechanism to the delivery system ( Figure 63 103 ) to prevent the use of the stabilizing mechanism 102 and the tongue-shaped member to transmit force in the delivery system.

[0153] Now go to Figure 82 and 83 , shows an exemplary embodiment with details regarding the docking post 201 subassembly. As shown, the docking post 201 is attached to the annuloplasty ring 101, and the stabilization mechanism 102 is attached via the docking post including the deactivation wire 210. Figure 84 and 85 An alternative embodiment is shown in which one or more docking posts 220 are integrated into the annuloplasty ring 101. In some embodiments, the docking posts 220 can be laser cut and bent outward from the wall of the annuloplasty ring 101. In other embodiments, the docking posts 220 can be permanently bent outward or have the ability to flex back into the wall of the annuloplasty ring 101, depending on the elasticity of the material.

[0154] Figure 84 and 85 The embodiment shown in FIG may not require additional components, but rather may be cut directly from the wall of the annuloplasty ring 101. Furthermore, in some embodiments, after the deactivation wire 210 is released, the docking posts 220 may return to their original position within the wall of the annuloplasty ring 101 (i.e., without leaving a residual footprint extending from the surface of the annuloplasty ring 101).

[0155] Now see Figures 86-93 , illustrates exemplary embodiments of various possible laser cut patterns for the docking post 220. As shown, the starting width 230, starting length 231, hole size 232, bend / torsion region 234, and radius 233 can vary based on design and needs. It should be understood that various other design patterns can be used. The possible patterns may be excessive, and thus the illustrated embodiments are for illustrative purposes only. In some embodiments, the geometry can vary based on the force required to maintain the stabilization mechanism 102, maintain and release the deactivation line 210, and / or bend or resist bending of the docking post (when associated with the annuloplasty ring 101).

[0156] Figure 94 and 95 An annuloplasty ring 101 is shown having a stabilizing mechanism 102 attached via one or more docking posts 201 and a deactivation wire 210. Figure 94 As shown in FIG, the stabilizing mechanism 102 is a single unit.

[0157] In an alternative embodiment, such as Figures 96-99 As shown in , the system may not require docking pole 201. Figures 96-99An exemplary embodiment is shown in which the stabilization mechanism 102 is attached to the annuloplasty ring 101 by one or more sutures. In some embodiments, the sutures can be wrapped around the stabilization mechanism 102. A suture-based attachment can be wrapped around the annuloplasty ring 101 and the stabilization mechanism 102. In one embodiment, the total number of wraps can vary from 1 to about 20 wraps, depending on the desired force. Alternatively, the suture-based attachment can be passed through a dedicated hole in the annuloplasty ring 101 or through the fabric surrounding the annuloplasty ring.

[0158] In another embodiment, the ends of the sutures can be threaded along the annuloplasty ring 101. For example, the ends of the sutures can be threaded inside the ring cannula, between the ring cannula and the outer fabric layer, or outside the fabric (e.g., through the delivery system interface 103 and through the delivery system lumen to the proximal end). One end of the suture can be pulled to release the annuloplasty ring 101. The stabilization mechanism 102 can then be disconnected from the annuloplasty ring 101. The stabilization mechanism (e.g., wire) can also be fully or partially retrieved through the delivery system and, if desired, completely removed from the delivery system.

[0159] Now see Figure 100 , shows an exemplary schematic diagram of at least one of the hypotubes 11. Figure 100 As shown, the hypotube 11 can include various segments with different properties. For example, a portion of the hypotube (e.g., 11) can be solid and, therefore, more structurally rigid and resilient. In another embodiment, a portion of the tube (e.g., 13) can be a flexible segment. In another embodiment, the flexible segment 13 can reside within one or more portions of the inner conduit 2 and the hypotube 11. For example, the flexible segment 13 can be inserted into one or more solid portions of the hypotube (e.g., 11 and / or 14).

[0160] Figure 100 Also shown is a segment 14 which may represent a solid portion of the hypotube 11. In some embodiments, the segment 14 may provide increased strength to allow for optimal pushing capabilities without flexing or changing position. In one embodiment, the hypotube 11 may have a distal section 15 which may be solid. It should be understood that Figure 100 The embodiments shown in the drawings are for illustrative purposes only, and various additional embodiments may exist or be used. For example, there may be additional segments (e.g., 5, 6, 7, ... 20, etc.) that are combined to form the complete hypotube 11. Furthermore, each segment may be independently constructed (e.g., the segments may have different materials, as disclosed herein) and may include different properties (e.g., more or less flexibility).

[0161] In another embodiment, and as Figure 101As shown in FIG, the distal end 13 of the hypotube 11 can have a pattern 16 cut into the construction material (e.g., a laser cut pattern). In one embodiment, the pattern 16 can be a spiral mushroom head pattern or any other pattern disclosed herein (e.g., Figure 2 、 3 , 4, 6, 7, 10, 11, 12, etc.) or be capable of providing sufficient flexibility and rigidity to deliver the stabilization mechanism 4 (i.e., allowing for varying flexibility that may be required to navigate sharp bends as the inner catheter 2 is navigated in a transseptal manner).

[0162] In some embodiments, the annuloplasty ring 3 can be controlled by applying tension and / or a biasing force to the proximal end of the stabilization mechanism 4, which is attached to the annuloplasty ring and passes through one or more hypotubes 11. In some embodiments, the applied tension can push the hypotubes 11 distally to engage the annuloplasty ring 3. Thus, as Figure 102 As shown in FIG, according to some embodiments, the stabilization mechanism 4 is attached to the annuloplasty ring 3 at a distal end and exits into a handle or manipulator at a proximal end. The stabilization mechanism 4 can then be removed by pulling one end of the stabilization mechanism at one of the proximal ends, thereby pulling the opposite proximal end (e.g., the rear end) away from the annuloplasty ring 3 (e.g., through the connection point 5) and through one or more hypotubes 11.

[0163] In the foregoing detailed description, reference is made to the accompanying drawings, which form a part hereof. In the drawings, similar symbols generally identify similar parts unless the context dictates otherwise. The illustrative embodiments described in the detailed description, drawings, and claims are not intended to be limiting. Other embodiments may be used, and other changes may be made, without departing from the spirit or scope of the subject matter presented herein. It will be readily understood that the various aspects of the present disclosure, as generally described herein and as illustrated in the accompanying drawings, may be arranged, substituted, combined, separated, and designed into a variety of different configurations, all of which are expressly contemplated herein.

[0164] The present disclosure is not limited with respect to the specific embodiments described in this application, which are intended to serve as illustrations of various aspects. It will be apparent to those skilled in the art that many modifications and variations can be made without departing from the spirit and scope of the invention. From the foregoing description, functionally equivalent methods and apparatus within the scope of the present disclosure, in addition to those enumerated herein, will be apparent to those skilled in the art. Such modifications and variations are intended to fall within the scope of the appended claims. The present disclosure is limited only by the terms of the appended claims and the full scope of equivalents to such claims. It should be understood that the present disclosure is not limited to specific methods, reagents, compounds, compositions or biological systems, which may of course vary. It should be understood that the terms used herein are used solely for the purpose of describing specific embodiments and are not intended to be limiting.

[0165] With respect to the use of substantially any plural and / or singular terms herein, those skilled in the art may translate from the plural to the singular and / or from the singular to the plural as appropriate to the context and / or application. For clarity, the various singular / plural permutations may be expressly set forth herein.

[0166] It will be understood by those skilled in the art that, in general, the terminology used herein, especially in the appended claims (e.g., the bodies of the appended claims), is generally intended to represent "open" terms (e.g., the term "including" should be interpreted as "including, but not limited to," the term "having" should be interpreted as "having at least," the term "includes" should be interpreted as "including, but not limited to," etc.). Although various compositions, methods, and apparatus have been described in terms of "comprising" various components or steps (interpreted to mean "including, but not limited to"), the compositions, methods, and apparatus may also "consist essentially of" or "consist of" the various components and steps, and such terms should be interpreted as defining substantially closed groups of members. It will also be understood by those skilled in the art that if a specific number of an introduced claim recitation is intended, such intent will be explicitly recited in the claim, and in the absence of such recitation, no such intent is present.

[0167] For example, to aid understanding, the following appended claims may contain use of the introductory phrases "at least one" and "one or more" to introduce claim recitations. However, the use of such phrases should not be construed as implying that introducing a claim recitation by the indefinite article "a" or "an" limits any particular claim containing such introduced claim recitation to embodiments containing only one such recitation, even when the same claim contains the introductory phrases "one or more" or "at least one" and an indefinite article such as "a" or "an" (e.g., "a" and / or "an" should be construed to mean "at least one" or "one or more"); the same applies to the use of definite articles used to introduce claim recitations.

[0168] Furthermore, even if a specific number of an introduced claim recitation is explicitly recited, one skilled in the art will recognize that such recitation should be interpreted to mean at least the recited number (e.g., a bare recitation of "two recitations" without other modifiers means at least two recitations or two or more recitations). Furthermore, in those instances where conventional expressions like "at least one of A, B, and C, etc." are used, generally speaking, the meaning of such construction is that one skilled in the art will understand the conventional expression (e.g., "a system having at least one of A, B, and C" will include, but is not limited to, systems having A alone, B alone, C alone, A and B together, A and C together, B and C together, and / or A, B, and C together, etc.). In those instances where conventional expressions similar to "at least one of A, B, or C, etc." are used, generally speaking, such constructions are meant to be understood by those skilled in the art (e.g., "a system having at least one of A, B, or C" would include, but is not limited to, systems having A alone, B alone, C alone, A and B together, A and C together, B and C together, and / or A, B, and C together, etc.). Those skilled in the art will also understand that, in fact, any discrete words and / or phrases presenting two or more alternative terms, whether in the specification, claims, or drawings, should be understood to contemplate the possibility of including one, either, or both of the terms. For example, the phrase "A or B" would be understood to include the possibility of "A" or "B" or "A and B."

[0169] In addition, where features or aspects of the disclosure are described in terms of Markush groups, those skilled in the art will recognize that the disclosure is also thereby described in terms of any individual member or subgroup of members of the Markush group.

[0170] As will be understood by those skilled in the art, for any and all purposes, such as for providing a written description, all ranges disclosed herein also encompass any and all possible subranges and combinations of their subranges. Any listed range can be readily identified as fully describing and enabling the same range to be divided into at least equal halves, thirds, quarters, fifths, tenths, etc. As a non-limiting example, each range discussed herein can be readily decomposed into a lower third, a middle third, and an upper third, etc. As will be understood by those skilled in the art, all language such as "at most," "at least," etc. includes the referenced number and refers to a range that can subsequently be decomposed into the subranges discussed above. Finally, as will be understood by those skilled in the art, a range includes each individual member. Thus, for example, a group having 1-3 units refers to a group having 1, 2, or 3 units. Similarly, a group having 1-5 units refers to a group having 1, 2, 3, 4, or 5 units, and so on.

[0171] The various features and functions disclosed above, as well as other features and functions, or alternatives thereof, may be combined into many other different systems or applications. Various presently unforeseen or unanticipated alternatives, modifications, variations, or improvements therein may be subsequently made by those skilled in the art, each of which is also intended to be encompassed by the embodiments disclosed herein.

Claims

1. A device for implantation in a heart, the device comprising: an annuloplasty ring configured to be delivered in a linear shape using a delivery system such that a flexible stabilization mechanism is used to achieve a desired positioning of the annuloplasty ring; one or more docking posts disposed on the annuloplasty ring, including two apertures disposed on opposite sides of each docking post, and configured to be removably coupled to the stabilization mechanism, the two apertures disposed on opposite sides of each docking post being configured to receive a deactivation wire of the flexible stabilization mechanism such that when the deactivation wire slides through the two apertures of each docking post, a distal end of the stabilization mechanism is secured to each docking post, Wherein the annuloplasty ring is configured to activate one or more anchors to extend outwardly from the annuloplasty ring.

2. The device of claim 1, wherein the flexible stabilizing mechanism comprises one or more sutures.

3. The device of claim 1 , wherein the one or more docking posts comprise one or more laser-cut portions of the annuloplasty ring.

4. The device of claim 1, wherein the flexible stabilization mechanism is a unitary body having a distal end, a first proximal end, and a second proximal end.

5. The device of claim 4, wherein the annuloplasty ring is desired positioned by a biasing force applied to at least one of the first proximal end and the second proximal end.

6. The device of claim 1 , wherein activation of the one or more anchors to extend outwardly from the annuloplasty ring is based on one or more predetermined areas on the annuloplasty ring.

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