Deployment systems, tools and methods for delivering anchoring devices for prosthetic valves

Abstract

The invention name of the present invention is a deployment system, tool and method for delivering an anchoring device for a prosthetic valve. In various embodiments, the delivery catheter is configured to deliver the anchoring device to the natural valve ring of the patient's heart, wherein the anchoring device can better fix the prosthesis at the natural valve ring. The delivery catheter may include a distal section, which includes one or more ridges or is laser cut to present a specific shape to better facilitate the delivery of the anchoring device at the implantation site, and may include a flexible tube, a first pull wire and a second pull wire. The flexible tube may include a hole extending between a first end and a second end, and the hole is sized to allow the anchoring device to pass therethrough. The distal portion may include a first flexure section and a second flexure section. Actuation of the first pull wire and the second pull wire can move the flexible tube from a first configuration to a second configuration.

Description

[0001] Related Applications

[0002] This application claims the benefit of U.S. Provisional Patent Application Serial No. 62 / 435,563, filed on December 16, 2016, entitled “DEPLOYMENT TOOLS AND METHODS FOR DELIVERING AN ANCHORING DEVICE FOR A PROSTHETIC VALVE AT A NATIVE VALVEANNULUS,” which is incorporated herein by reference in its entirety. Technical Field

[0003] The present disclosure generally relates to deployment tools and methods of using the same, which are used to deliver anchoring devices, such as prostheses docking devices that support prostheses. For example, the present disclosure relates to replacement of a heart valve having a malformation and / or dysfunction, wherein an anchoring device that supports a prosthetic heart valve is deployed at an implantation site using a flexible delivery catheter, and methods of implanting such an anchoring device and / or a prosthetic heart valve using a delivery catheter. Background Art

[0004] Overall reference Figure 1A-1B , the natural mitral valve 50 controls the flow of blood from the left atrium 51 to the left ventricle 52 of the human heart, and similarly, the tricuspid valve 59 controls the flow of blood between the right atrium 56 and the right ventricle 61. The mitral valve has an anatomical structure different from other natural heart valves. The mitral valve includes a valve ring composed of natural valve tissue surrounding the mitral valve orifice, and a pair of cusps or leaflets extending downward from the valve ring to the left ventricle. The mitral valve ring can form a "D" shape, elliptical or other non-circular cross-sectional shape with a major axis and a minor axis. The anterior leaflet of the valve can be larger than the posterior leaflet, and when they are closed together, a generally "C"-shaped boundary is formed between the adjacent free edges of the leaflets.

[0005] When functioning normally, the anterior leaflet 54 and the posterior leaflet 53 of the mitral valve act together as a one-way valve to allow blood to flow from the left atrium 51 to the left ventricle 52. After the left atrium receives oxygenated blood from the pulmonary veins, the muscles of the left atrium contract and the left ventricle relax (also known as "ventricular diastole" or "diastole"), and the oxygenated blood collected in the left atrium flows into the left ventricle. Then, the muscles of the left atrium relax, and the muscles of the left ventricle contract (also known as "ventricular systole" or "systole") to move the oxygenated blood away from the left ventricle 52 and through the aortic valve 63 and the aorta 58 to other parts of the body. During ventricular systole, the increase in blood pressure in the left ventricle forces the two leaflets of the mitral valve together, thereby closing the one-way mitral valve so that blood cannot flow back into the left atrium. To prevent or inhibit the two leaflets from prolapsing under pressure and folding back through the mitral annulus toward the left atrium during ventricular systole, a plurality of fibrous cords 62, called chordae tendineae, tether the leaflets to the papillary muscles in the left ventricle. Figure 1A Heart cross section and Figure 1B The chordae tendineae 62 are schematically illustrated in the top view of the mitral valve in FIG.

[0006] Problems with the proper functioning of the mitral valve is a type of valvular heart disease. Vascular heart disease can also affect other heart valves, including the tricuspid valve. A common form of valvular heart disease is valve leakage, also known as regurgitation, which can occur in various heart valves, including the mitral and tricuspid valves. Mitral regurgitation occurs when the native mitral valve fails to close properly and blood flows from the left ventricle back into the left atrium during ventricular contraction. Mitral regurgitation can have different causes, such as leaflet prolapse, papillary muscle dysfunction, problems with the chordae tendineae, and / or stretching of the mitral annulus caused by left ventricular dilation. In addition to mitral regurgitation, mitral valve narrowing or stenosis is another example of valvular heart disease. In tricuspid regurgitation, the tricuspid valve fails to close properly and blood flows from the right ventricle back into the right atrium.

[0007] Like the mitral and tricuspid valves, the aortic valve is also susceptible to complications such as aortic stenosis or aortic insufficiency. One method for treating aortic heart disease includes the use of a prosthetic valve implanted in the natural aortic valve. These prosthetic valves can be implanted using various techniques, including various transcatheter techniques. A transcatheter heart valve (THV) can be mounted in a curled state on the end portion of a flexible and / or steerable catheter, advanced to an implantation site in the heart via a blood vessel connected to the heart, and then expanded to its functional size, for example, by inflating a balloon on which the THV is mounted. Optionally, a self-expanding THV can be maintained in a radially compressed state within the sheath of a delivery catheter, wherein the THV can be deployed from the sheath, and the sheath allows the THV to expand to its functional state. This delivery catheter and implantation technology are generally more advanced (developed) for implantation or use in the aortic valve, but do not address the unique anatomical structures and challenges of other valves. Summary of the invention

[0008] The present invention is intended to provide some examples, and is not intended to limit the scope of the present invention in any way. For example, unless the claim clearly defines a feature, the claim does not require any feature included in the example of the present invention. Moreover, the features described can be combined in various ways. The various features and steps described in other parts of this disclosure can be included in the examples summarized here.

[0009] Tools and methods for mitral and tricuspid valve replacement are provided, including adapting different types of valves or multiple valves (e.g., those designed for aortic valve replacement or other positions) to the mitral and tricuspid positions. One way to adapt these other prosthetic valves in the mitral or tricuspid position is to deploy the prosthetic valve into an anchor or other docking device / docking station that will form a more appropriately shaped implantation site at the native valve annulus. The anchor or other docking device / docking station herein allows for a more secure implantation of the prosthetic valve while also reducing or eliminating leakage around the valve after implantation.

[0010] One type of anchor or anchoring device that can be used herein is a coil or spiral anchor that provides a circular or cylindrical docking site for a cylindrical prosthetic valve. One type of anchor or anchoring device that can be used herein includes a coiled region and / or a spiral region that provides a circular or cylindrical docking site for a cylindrical prosthetic valve. In this way, optionally, an existing valve implant developed for an aortic position (possibly with some modifications) can be implanted with such an anchor or anchoring device to other valve positions, such as a mitral valve position. Such an anchor or anchoring device can also be used with other natural valves of the heart (such as the tricuspid valve) to more securely anchor the prosthetic valve in those locations.

[0011] Embodiments of deployment tools that assist in delivering a prosthetic device at one of the regions of the native mitral, aortic, tricuspid, or pulmonary valves of a human heart, and methods of using the deployment tools are described herein. The disclosed deployment tools can be used to deploy anchoring devices (e.g., prosthetic docking devices, prosthetic valve docking devices, etc.) at an implantation site, such as a helical anchoring device or an anchoring device having multiple turns or coils, to provide a base support structure in which a prosthetic heart valve can be implanted. The delivery tool may include a distal curved section to guide the positioning of the anchor or anchoring device as it is implanted.

[0012] In one embodiment, a delivery catheter for delivering an anchoring device to a natural annulus of a patient's heart, wherein the anchoring device is configured to fix a prosthesis (e.g., a prosthetic heart valve) to the natural annulus, comprises a flexible tube, a first pull wire, and a second pull wire. The flexible tube comprises a proximal portion having a first end, a distal portion having a second end, and a hole extending between the first end and the second end. The hole is sized to allow the anchoring device to pass therethrough. The distal portion comprises a first flexing section and a second flexing section. The delivery catheter can be configured so that actuation of the first pull wire and the second pull wire causes the flexible tube to move from a first configuration to a second configuration. When the flexible tube is in the second configuration, the first flexing section can form a first curved portion, and the second flexing section can form a generally circular and generally planar portion.

[0013] The delivery catheter may have a first ring and a second ring. The first ring may be arranged at a first actuation point, and the first pull wire may be attached to the first ring. The second ring may be arranged at a second actuation point, and the second pull wire may be attached to the second ring. The first pull wire may be offset in a circumferential direction from the second pull wire by between about 65 degrees and about 115 degrees, such as offset by about 90 degrees.

[0014] The catheter may include a third ring disposed between the proximal portion and the second ring. A first spine may be disposed between the first ring and the second ring. A second spine may be disposed between the second ring and the third ring. The first spine may be configured to limit the compressive movement between the first ring and the second ring when the flexible tube is moved to the second configuration. The second spine may be configured to limit the bending caused by the first pull wire between the second ring and the third ring when the flexible tube is moved to the second configuration. The ratio of the Shore D hardness of the first spine to the Shore D hardness of the second spine may be between about 1.5:1 and about 6:1.

[0015] The flexible end portion may be configured to be angled relative to the main portion of the rounded or curved planar portion. For example, the vertical displacement between the flexible end portion and the main portion may be between about 2 mm and about 10 mm.

[0016] The catheter may also include a first coiled sleeve extending around at least a portion of the first puller wire and / or a second coiled sleeve extending around at least a portion of the second puller wire.

[0017] In a method of delivering an anchoring device to a native valve of a patient's heart using a delivery catheter, the delivery catheter can be advanced into the heart (e.g., into a chamber of the heart, such as the atrium). A first curved portion can be created in a first flexure section of the delivery catheter, and a generally circular or curved (e.g., curved to simulate or resemble a circular shape) and generally planar portion can be created in a second flexure section of the delivery catheter. The distal opening at the end of the generally circular portion can be positioned in the direction of the commissure of the native valve. The anchoring device is delivered to the native valve via the catheter. The height or angle of the distal opening of the delivery catheter can be optionally adjusted so that at least a portion of the delivery catheter is substantially parallel to the plane of the annulus of the native valve or a plane passing through the native annulus.

[0018] In another embodiment, a method of delivering an anchoring device to a native valve annulus of a patient's heart using a delivery catheter, wherein the anchoring device is configured to secure a prosthesis to the native valve annulus, includes advancing the delivery catheter into the heart (e.g., into a chamber of the heart, such as an atrium), bending the delivery catheter at least partially around the native valve annulus so that a distal opening of the delivery catheter is positioned proximate to the commissures of the native valve, and adjusting at least one of an extended height or angle of the delivery catheter so that at least a portion of the delivery catheter is substantially parallel to a plane containing the native valve annulus. When the native valve is a mitral valve, the delivery catheter is advanced from the right atrium into the left atrium via the atrial septum.

[0019] The systems and catheters outlined herein may also include any of the features, components, elements, etc. described elsewhere in this disclosure, and the methods outlined herein may also include any of the steps described elsewhere in this disclosure. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The foregoing and other objects, features and advantages of the present invention will become more apparent from the following detailed description using the accompanying drawings. In the accompanying drawings:

[0021] Figure 1A A schematic cross-sectional view of a human heart is shown;

[0022] Figure 1B A schematic top view of the mitral valve annulus of the heart is shown;

[0023] Figure 2A A perspective view of an exemplary anchoring device showing a helical shape;

[0024] Figure 2B A partial perspective view of an exemplary delivery device for implanting an anchoring device in a native valve of a heart using a transseptal technique is shown;

[0025] Figure 2C shows a cross-sectional view of an anchoring device and an exemplary prosthetic heart valve implanted in a native valve of the heart;

[0026] Figure 3A shows a perspective view of an exemplary distal section of a delivery catheter used as part of an exemplary delivery device for implanting an anchoring device;

[0027] Figure 3B yes Figure 3A A cross-sectional view of several links of the distal segment;

[0028] Figure 4 is a perspective view of a distal section of a delivery catheter in a bent or curved configuration;

[0029] Figure 5 is a plan view of an exemplary laser cut sheet that can be used to form a distal section of a delivery catheter;

[0030] Figure 6 is a plan view of another exemplary laser cut sheet that may be used to form a distal section of a delivery catheter;

[0031] Figure 7 is a plan view of another exemplary laser cut sheet that may be used to form a distal section of a delivery catheter;

[0032] Figure 8 A perspective view showing a bent or curved configuration of a distal section of a delivery catheter that can be used to implant an anchoring device into a native valve, for example using a transseptal technique;

[0033] Fig.9A is a side cutout view of a portion of a patient's heart illustrating an exemplary delivery device entering the left atrium through the fossa ovalis in an exemplary method;

[0034] Fig. 9B Example of entering the Fig.9A The left atrium of the patient's heart is shown in the Fig.9A A delivery device, wherein Fig.9A The view taken along line BB in FIG. 1 shows the delivery device;

[0035] Fig. 9C Example of a second position Fig.9A delivery device;

[0036] Fig.9D Example of Fig. 9C The second position shown in Fig.9A A delivery device, wherein Fig. 9C The view taken along line DD in FIG. 1 shows the delivery device;

[0037] Fig.9E Example of a third position Fig.9A delivery device;

[0038] Fig.9F Example of Fig.9E The third position shown in Fig.9A A delivery device, wherein Fig.9E The view taken along line FF in FIG. 1 shows the delivery device;

[0039] Figure 9G Example of the fourth position Fig.9A delivery device;

[0040] Figure 9H Example of Figure 9G The fourth position shown in Fig.9A A delivery device, wherein Figure 9G The view taken along line HH in FIG. 1 shows the delivery device;

[0041] Fig.9I is a side cross-sectional view of the left side of a patient's heart illustrating an anchoring device delivered around chordae tendineae and leaflets in a left ventricle of the patient's heart;

[0042] Figure 9J Example Fig.9I The anchoring device, when it passes Fig.9A The delivery device, when delivered, further wraps around chordae tendineae and leaflets in a left ventricle of a patient's heart;

[0043] Figure 9K Example Fig.9I The anchoring device, when it passes Fig.9A The delivery device, when delivered, further wraps around chordae tendineae and leaflets in a left ventricle of a patient's heart;

[0044] Figure 9L is a view looking down into the patient's left atrium, illustrating the Fig.9I The anchoring device is wrapped around the chordae tendineae and leaflets in the left ventricle of the patient's heart. Fig.9A delivery device;

[0045] Figure 9MAn example of a patient's left atrium Fig.9A a delivery device, wherein the delivery device is retracted to deliver a portion of the anchoring device into the left atrium of the patient's heart;

[0046] Figure 9N An example of a patient's left atrium Fig.9A a delivery device for delivering an anchor device to a left atrium of a patient's heart, wherein the delivery device is retracted to deliver a further portion of the anchor device to a left atrium of a patient's heart;

[0047] Fig.9O An example of a patient's left atrium Fig.9A a delivery device wherein the anchoring device is exposed and shown tightly coupled to the pusher in the left atrium of the patient's heart;

[0048] Figure 9P An example of a patient's left atrium Fig.9A a delivery device wherein the anchoring device is completely removed from the delivery device and is loosely and removably attached to the pusher by sutures;

[0049] Figure 9Q is a cross-sectional view of a patient's heart illustrating an exemplary embodiment of a prosthetic heart valve being delivered to a mitral valve of the patient via an exemplary embodiment of a heart valve delivery device;

[0050] Figure 9R The invention further illustrates a method of delivering a heart valve to a patient's mitral valve via a heart valve delivery device. Figure 9Q heart valves;

[0051] Figure 9S The invention illustrates a method of expanding a heart valve by inflating a balloon to expand the heart valve and attaching the heart valve to the patient's mitral valve. Figure 9Q heart valves;

[0052] Figure 9T Attached to the mitral valve of the patient's heart and through Fig.9I Anchor device fixed Figure 9Q heart valves;

[0053] Figure 9U is an upward view of the mitral valve from the left ventricle, illustrating the Figure 9T A view taken along line UU in FIG. 1 is attached to the mitral valve of a patient's heart. Figure 9Q prosthetic heart valves;

[0054] Fig.10 A perspective view showing a helical configuration of a distal section of a delivery catheter that can be used to implant an anchoring device into a native valve, optionally in a transseptal technique;

[0055] Fig.11A perspective view showing a hybrid configuration of a distal section of a delivery catheter that can be used to implant an anchoring device into a native valve, which can optionally be used in a transseptal technique;

[0056] Fig.12 shows a partial perspective view of an exemplary delivery device that can be used to implant an anchoring device into a native mitral valve, for example using another transseptal technique;

[0057] Fig.13 shows a schematic side view of an exemplary distal section of a delivery catheter having an exemplary dual control wire or pull wire system that can be used in various delivery catheters or delivery devices herein;

[0058] Fig.14 Shows Fig.13 A cross-sectional view of a multi-lumen extrusion portion of a delivery catheter, the cross section being taken in a plane perpendicular to a longitudinal axis of the delivery catheter;

[0059] Fig.15 Shown in partially actuated state Figure 13-14 A schematic perspective view of a delivery catheter;

[0060] Fig.16 Shown in fully actuated state Figure 13-15 A schematic perspective view of a delivery catheter;

[0061] Figures 17A-17C shows a perspective view of an exemplary lock or locking mechanism for an anchoring device;

[0062] Fig.17D yes Figures 17A-17C A cross-sectional view of a lock or locking mechanism;

[0063] Figures 18A-18C shows a perspective view of another exemplary lock or locking mechanism for an anchor device according to one embodiment; and

[0064] Fig.19 shows a perspective view of an exemplary distal section of a delivery catheter that may be used as part of a delivery device for implanting an anchoring device;

[0065] Fig. 20A is an end view of another exemplary embodiment of a delivery catheter;

[0066] Fig. 20B is along Fig. 20A A cross-sectional view taken along the plane shown by line BB in FIG.

[0067] Fig. 20C is along Fig. 20C A cross-sectional view taken along the plane indicated by line CC in FIG.

[0068] Fig.20D is along Fig. 20C A cross-sectional view taken along the plane indicated by line DD in FIG.

[0069] Fig.20E is along Fig. 20C A cross-sectional view taken along the plane indicated by line EE in FIG.

[0070] Fig.21A Shown in partially actuated state Figures 20A-20E A schematic perspective view of a distal section of a delivery catheter;

[0071] Fig. 21B Shows a more actuated state Figures 20A-20E A schematic perspective view of a distal section of a delivery catheter;

[0072] Fig.22A yes Figures 20A-20E A partial view of a delivery catheter;

[0073] Figures 22B-22C Shows Fig.22A A cross-sectional view of the delivery catheter shown in , the cross-section being taken in a plane perpendicular to the longitudinal axis of the delivery catheter; and

[0074] Fig.23 Shows the Figures 20A-20E Schematic diagram of an exemplary dual pull wire system of a delivery catheter shown in . DETAILED DESCRIPTION

[0075] The following description and accompanying drawings, which describe and show certain embodiments, are intended to illustrate, in a non-limiting manner, several possible configurations of systems, devices, apparatuses, assemblies, methods, etc., that may be used with various aspects and features of the present disclosure. As an example, the various systems, devices / apparatus, assemblies, methods, etc. described herein may relate to mitral valve procedures. However, the specific examples provided are not intended to be limiting, for example, the systems, devices / apparatus, assemblies, methods, etc. may be applicable to valves other than the mitral valve (e.g., for use in the tricuspid valve).

[0076] Described herein are embodiments of deployment tools intended to facilitate implantation of a prosthetic device (e.g., a prosthetic valve) in one of the natural mitral, aortic, tricuspid, or pulmonary valve regions of a human heart, and methods of using the deployment tools. The prosthetic device or valve can be an expandable transcatheter heart valve ("THV") (e.g., a balloon-expandable, self-expandable, and / or mechanically expandable THV). The deployment tool can be used to deploy an anchoring device (sometimes referred to as a docking device, docking station, or similar terminology) that provides a more stable docking site to secure the prosthetic device or valve (e.g., THV) to the natural valve region. These deployment tools can be used to more accurately place such anchoring devices (e.g., prosthetic anchoring devices, prosthetic valve anchoring devices, etc.) so that after implantation, the anchoring device and any prosthesis anchored thereto (e.g., a prosthetic device or prosthetic heart valve) function properly.

[0077] Figure 2A An example of such an anchoring device is shown in . Other examples of anchoring devices that can be used herein are shown in U.S. Patent Application Serial Nos. 15 / 643,229, 15 / 684,836, and 15 / 682,287, each of which is incorporated herein by reference in its entirety. The anchoring devices herein can be coiled or spiral, or they can include one or more coiled or spiral regions. Figure 2A The anchoring device 1 shown in includes two upper coils 10a, 10b and two lower coils 12a, 12b. In optional embodiments, the anchoring device 1 may include any suitable number of upper coils and lower coils. For example, the anchoring device 1 may include one upper coil, two or more upper coils, three or more upper coils, four or more upper coils, five or more upper coils, etc. In addition, the anchoring device 1 may have one lower coil, two or more lower coils, three or more lower coils, four or more lower coils, five or more lower coils, etc. In various embodiments, the anchoring device 1 may have the same number of upper coils as the lower coils it has. In other embodiments, the anchoring device 1 may have more or fewer upper coils than the lower coils.

[0078] The anchoring device may include coils / turns with varying diameters or the same diameter, coils / turns spaced with varying gap sizes or without gaps, and coils / turns that taper, expand, or flare to become larger or smaller. It should be noted that the coils / turns may also stretch radially outward when the prosthetic valve is placed or expanded within the anchoring device 1.

[0079] exist Figure 2AIn an exemplary embodiment, the upper coils 10a, 10b can be approximately the same size as the lower coils 12a, 12b or can have a diameter slightly smaller than the diameter of the lower coils 12a, 12b. One or more lower end coils / turns (e.g., all or part of the end coils / turns) can have a larger diameter or a larger radius of curvature than the other coils and act as a wrap-around coil / turn to help guide the ends of the coils outside and around the leaflets and / or any chordae tendineae, for example, to wrap around and corral the leaflets and / or any chordae tendineae. One or more lower coils or wrap-around coils of larger diameter or larger radius allow for easier engagement with the native annulus during insertion and navigation around the native valve anatomy.

[0080] In some embodiments, one or more of the upper coils / turns (e.g., all or part of the coils / turns) can be larger or have a larger diameter (or radius of curvature) and act as a stabilizing coil (e.g., in the atria of the heart) to help hold the coil in place before the prosthetic valve is deployed therein. In some embodiments, one or more of the upper coils / turns can be atrial coils / turns and can have a larger diameter than the coils in the ventricles, e.g., acting as a stabilizing coil / turn configured to engage the atrial wall for stabilization.

[0081] Some of the coils may be functional coils (e.g., coils / turns between stabilizing coil(s) / turn(s) and surrounding coil(s) / turn(s)) in which the prosthetic valve is deployed, and forces between the functional coils and the prosthetic valve help hold each other in place. The anchoring device and the prosthetic valve may pinch native tissue (e.g., leaflets and / or chordae tendineae) between them (e.g., between the functional coils of the anchoring device and the outer surface of the prosthetic valve) to more securely hold them in place.

[0082] In can with Fig.9I In an embodiment the same as or similar to the anchoring device shown in -9U, the anchoring device has a large upper coil / turn or stabilizing coil / turn, a lower end coil / turn or surrounding coil / turn, and multiple functional coils / turns (e.g., 2, 3, 4, 5 or more functional coils / turns).

[0083] For example, Figure 2CAs shown in , when used in the mitral valve position, the anchoring device can be implanted so that one or more upper coils / turns (e.g., upper coils 10a, 10b) are above the native valve ring (e.g., mitral valve 50 or tricuspid valve), i.e., on the atrial side, and the lower coils 12a, 12b are below the native valve ring, i.e., on the ventricular side. In this configuration, the mitral valve leaflets 53, 54 can be captured between the upper coils 10a, 10b and the lower coils 12a, 12b. When implanted, the various anchoring devices herein can provide a solid support structure to fix the prosthetic valve in place and prevent migration due to the operation of the heart.

[0084] Figure 2B A general delivery device 2 for installing an anchoring device at a native mitral valve annulus 50 using a transseptal technique is shown. The same or similar delivery device 2 can be used to deliver an anchoring device at the tricuspid valve without having to leave the right atrium to cross the septum into the left atrium. The delivery device 2 includes an outer sheath or guide sheath 20 and a flexible delivery catheter 24. The sheath 20 has a shaft in the shape of an elongated hollow tube through which the delivery catheter 24 and various other components (e.g., anchoring devices, prosthetic heart valves, etc.) can pass, thereby allowing the components to be introduced into the patient's heart 5. The sheath 20 can be maneuverable so that the sheath 20 can be bent at various angles required to sheath through the heart 5 and into the left atrium 51. When in the sheath 20, the delivery catheter 24 is in a relatively straight or straightened configuration (compared to the bent configuration discussed in more detail below), for example, the delivery catheter 24 is retained in the sheath 20 in a configuration or shape corresponding to the configuration or shape of the sheath 20.

[0085] Like the sheath 20, the delivery catheter 24 has a shaft in the shape of an elongated hollow tube. However, the delivery catheter 24 has a smaller diameter than the sheath 20 so that it can slide axially within the sheath 20. At the same time, the delivery catheter 24 is large enough to accommodate and deploy an anchoring device, such as the anchoring device 1.

[0086] The flexible delivery catheter 24 also has a flexible distal section 25. The distal section 25 can be bent into a configuration that allows for more precise placement of the anchoring device 1, and should generally have a robust design that allows the distal section 25 to bend and remain in such a configuration. Figure 2BAs shown, the flexible distal section 25 can be bent into a curved configuration, wherein the distal section 25 is bent to assist in squeezing out or pushing out the anchoring device 1 on the ventricular side of the mitral valve 50, so that the lower coil (e.g., functional coil and / or surrounding coil) of the anchoring device 1 can be properly installed below the natural valve ring. The flexible distal section 25 can also be bent into the same or different curved configurations so that the upper coil (one or more) of the anchoring device (e.g., stabilizing coil / turn or upper coil 10a, 10b) can be accurately deployed on the atrial side of the natural valve ring. For example, the flexible distal section 25 can have the same configuration for installing the upper coil 10a, 10b as for installing the lower coil 12a, 12b. In other embodiments, the flexible distal section 25 can have one configuration for installing the lower coil 12a, 12b and another configuration for installing the upper coil 10a, 10b. For example, the flexible distal section 25 may be translated axially and posteriorly from the above-described position, thereby releasing the lower coils 12a, 12b to release and position the upper coils 10a, 10b on the atrial side of the native annulus.

[0087] In use, when utilizing a transseptal delivery approach to access the mitral valve, the sheath 20 may be inserted through the femoral vein, through the inferior vena cava 57, and into the right atrium 56. Alternatively, the sheath 20 may be inserted through the jugular vein or subclavian vein or other superior vasculature location and through the superior vena cava into the right atrium. Figure 2B As can be seen, the atrial septum 55 is then punctured (e.g., at the fossa ovalis) and the sheath 20 is passed into the left atrium 51. (In a tricuspid valve procedure, the septum 55 need not be punctured or crossed.) The sheath 20 has a distal portion 21, which may be a steerable or pre-curved distal portion to facilitate manipulation of the sheath 20 into the desired chamber of the heart (e.g., the left atrium 51).

[0088] In a mitral valve procedure, with the sheath 20 in place in the left atrium 51, the delivery catheter 24 is advanced from the distal end 21 of the sheath 20 so that the distal section 25 of the delivery catheter 24 is also in the left atrium 51. In this position, the distal section 25 of the delivery catheter 24 can be bent or curved into one or more curved or activated configurations (one or more) to allow the anchoring device 1 to be installed at the annulus of the mitral valve 50. The anchoring device 1 can then be advanced through the delivery catheter 24 and installed at the mitral valve 50. The anchoring device 1 can be attached to a pusher that advances or pushes the anchoring device 1 through the delivery catheter 24 for implantation. The pusher can be a wire or tube having sufficient strength and physical properties to push the anchoring device 1 through the delivery catheter 24. In some embodiments, the pusher can be made of or include: a spring or a coil (e.g., see below Figures 17A-18CIn some embodiments, the pusher may have a coating on and / or inside thereof, for example, the pusher may have an inner cavity lined with PTFE to allow a line (e.g., a suture) to be actuated atraumatically through the lined inner cavity. As described above, in some embodiments, after the pusher has pushed the ventricular coil of the anchoring device 1 into and properly positioned it in the left ventricle, the distal section 25 may, for example, be translated axially backward to release the atrial coil of the anchoring device 1 into the left atrium while maintaining or holding the position of the ventricular coil of the device 1 in the left ventricle.

[0089] Once the anchoring device 1 is installed, the delivery catheter 24 can be removed by straightening or reducing the curvature of the flexible distal section 25 to allow the delivery catheter 24 to be returned through the sheath 20. For example, Figure 2C As shown in , with the delivery catheter 24 removed, a prosthetic valve, such as a prosthetic transcatheter heart valve (THV) 60 can then be passed through the sheath 20, for example, and secured within the anchoring device 1. When the THV 60 is secured within the anchoring device 1, the sheath 20 can then be removed from the patient's body along with any other delivery devices for the THV 60, and the patient's septum 55 and the opening in the right femoral vein can be closed. In other embodiments, after the anchoring device 1 is implanted, a different sheath or a different delivery device can be used alone to deliver the THV 60. For example, a guidewire can be introduced through the sheath 20, or the sheath 20 can be removed, and a separate delivery catheter can be used to advance the guidewire through the native mitral valve and into the left ventricle via the same access point. At the same time, even if the anchoring device is implanted in a transseptal manner in this embodiment, it is not limited to transseptal implantation, and the delivery of the THV 60 is not limited to transseptal delivery (or more generally, via the same access point as the delivery of the anchoring device). In other embodiments, following transseptal delivery of the anchoring device 1, the THV 60 may thereafter be implanted using any of a variety of other access points, such as transapically, transcranially, or via the femoral artery.

[0090] Figure 3A A perspective view of an exemplary distal segment 25 that can be used in a delivery catheter 24 is shown. The distal segment includes two opposing ends, two opposing sides 26 & 27, a top 28, and a bottom 29 extending between the two ends. These have been labeled to facilitate description and understanding, and are not intended to limit the orientation of the distal segment 25. Figure 3AThe distal section 25 of the embodiment is formed into a generally cylindrical hollow tube that may include a plurality of joints 38. Each joint 38 has the shape of a cylindrical segment, and each joint 38 is aligned and connected with adjacent joints 38 to form the cylindrical tube shape of the distal section 25. Although the distal section 25 is cylindrical in this embodiment, other shapes, such as an oval distal section, are also possible. Figure 3B As best shown in FIG. 2 , each link 38 of the distal section 25 may have a greater width at the bottom 29 than at the top 28, thereby providing the link 38 with an overall shape of an acute trapezoid when viewed from the side. The bottom of each link 38 may have a slit 39 to allow the links 38 to flex more relative to each other.

[0091] The distal section 25 may include a dual guide pattern that forms a mixed curved section including two side teeth 31, 32 and a top tooth 33. To this end, each joint 38 may include two side teeth 31, 32 and a top tooth 33 on opposite sides of the joint 38. Figure 3A As best shown in FIG. 1 , with respect to the distal segment 25, the two rows of side teeth 31, 32 of the coupling 38 can extend the length of the sides 26, 27 of the distal segment 25, respectively, and the top teeth 33 can extend the length of the distal segment 25 on the top 28. Although the rows of side teeth 31, 32 and top teeth 33 are shown as extending straight along the length of the distal segment 25 in this example embodiment, other embodiments can have different configurations. For example, in some embodiments, the rows of side teeth 31, 32 and top teeth 33 can spiral around the tube of the distal segment 25, such as Figure 4 As shown, when the distal segment 25 is actuated, a specific curved shape of the distal segment 25 is achieved. In some embodiments, the side teeth 31, 32 can be mirror images of each other to allow similar curvature on the opposite sides 26, 27 of the distal segment 25. In other embodiments, the side teeth 31, 32 can have different shapes and / or sizes compared to each other. The teeth 31, 32, 33 can have any other suitable shape and / or size that allows the distal segment 25 to move into a flexed configuration when the anchoring device is delivered. Although in the example embodiment, the teeth 31, 32, 33 are all right-facing teeth (for example, in Figure 3B ), but in other embodiments, for example, the teeth may be teeth facing left (see, for example, Figure 4 ) or the top teeth and side teeth can face different directions.

[0092] Adjacent each side tooth 31, 32 and each top tooth 33 are corresponding side slots or grooves 34, 35 and top slots or grooves 36 on the adjacent joint 38, respectively. Each slot 34, 35, 36 may have a shape complementary to the side tooth 31, 32 or top tooth 33 adjacent thereto. When the distal section 25 is in the straightened configuration, the side teeth 31, 32 are partially inserted into the side slots 34, 35, and the top teeth 33 are separated from the top slots 36 adjacent thereto by a gap. When the distal section 25 of the delivery catheter 24 is not fully flexed, having the side teeth 31, 32 in such a straightened configuration partially located within the side slots 34, 35 provides additional torque resistance to the distal section 25. However, in other embodiments, when the distal section 25 is in the straightened configuration, the side teeth 31, 32 may not be partially located within the side slots 34, 35.

[0093] As the distal segment 25 bends, each side tooth 31, 32 moves further into its corresponding side slot 34, 35, and each top tooth 33 moves closer to its corresponding top slot 36 and then enters its corresponding top slot 36. When the distal segment 25 is in a fully flexed configuration, the addition of the top teeth 33 and top slots 36 provides enhanced torqueability and torque resistance to the distal segment 25. Further, when the distal segment 25 is adjusted from its straightened configuration to its flexed configuration, the presence of the side teeth 31, 32 and top teeth 33 all provide additional guidance control and structural support.

[0094] Figure 3B yes Figure 3A Detailed cross-sectional view of several joints 38 of the distal section 25. Figure 3B The description is made with respect to the side teeth 32, which description is equally applicable to the side teeth 31 on the opposite side of the distal segment 25. The side teeth 32 are shown positioned along a tooth line 40 that is low relative to the top 28 of the distal segment 25. This positioning results in the side teeth 32 having a smaller displacement, that is, the distance that the side teeth 32 move into the adjacent slot 35 is much shorter or less than if the side teeth 32 were positioned closer to the top 28 of the distal segment 25. For example, in the example embodiment, the side teeth 31, 32 move a smaller distance during flexure than the top teeth 33. In other words, when the distal segment 25 is adjusted to a fully bent configuration, the top teeth 33 move a greater distance relative to the adjacent joint 38 than the side teeth 31, 32. This arrangement allows the use of shorter side teeth 31, 32 (e.g., side teeth having a shorter longitudinal length), which in turn can be incorporated into shorter curved segments in the distal segment 25.

[0095] Further, since the tooth slots 34, 35 are located in the wider lower portion of the coupling 38, the low tooth line also provides more space for the wider tooth slots 34, 35 to accommodate, for example, even larger side teeth. Larger and / or more suitable or stable tooth slots 34, 35 with more space to accommodate the side teeth 31, 32 can, for example, enhance the guidance of the teeth 31, 32 into the slots 34, 35 during bending. The low tooth line also allows for the stable tooth design discussed above, which can still provide structural support when the coupling is bent away from each other, that is, in opposite directions of the bending configuration. Therefore, when the coupling is bent away from each other, the side teeth can still maintain their interface with the adjacent side slots, and this maintained tooth slot interface can provide more structural support and twistability.

[0096] Figure 4 is a perspective view of the distal section 25 ′ in a bent configuration according to a modification of the first embodiment. Figure 4 The distal section 25' in is similar to Figure 3A The distal segment 25 is different from Figure 4 The row of central top teeth 33' and the rows of side teeth 31', 32' are laterally shifted around the tubular distal segment 25', rather than continuing in a straight line along the length of the distal segment. This positioning of the rows of teeth 31', 32', 33' along, for example, a helical line allows the distal segment 25' to bend in three dimensions, with Figure 3A The single plane that will appear in the Figure 4 As shown, the exemplary distal segment 25' has a three-dimensional curved shape. Various embodiments of the distal segment can be laser cut (e.g., into a sheet or tube) so that the top and side teeth follow a pattern that will form a desired shape during bending. For example, a pattern can be cut to produce a distal segment with a curved shape that, when used in a surgical procedure, allows the distal segment to be positioned at the mitral valve or other valve so that the anchoring device can be advanced from the distal segment and accurately positioned at the valve.

[0097] The distal segments 25, 25' can be manufactured by cutting, e.g., by laser cutting, a flat metal strip or sheet to have the desired pattern and then rolling the patterned metal strip or sheet into a hypotube. Alternatively, the desired pattern (e.g., a pattern the same as or similar to that shown in the various figures herein) can be cut directly into a tube (e.g., a hypotube) without using a sheet or having to roll the material. As an example, Figure 5 Shows the available Figure 3AFIG. 2 is a plan view of an exemplary laser cut file or sheet 30 of a distal section 25 of FIG. The laser cut sheet 30 includes top teeth 33 and their associated slots 36 and side teeth 31, 32 and their associated slots 34, 35 arranged in straight rows along the length of the distal section 25. However, as described above, in order to produce a similar Figure 4 In contrast to the curved or spirally curved distal section 25' shown in FIG. 1 , the laser cutting file 30 can be modified to arrange the teeth 31, 32, 33 and their associated slots 34, 35, 36 in other different paths or configurations, for example, in rows of spiral lines. In other embodiments, various such patterns can be cut: they provide other shapes or configurations of curved distal sections that can help accurately guide and deploy the anchoring device to the location of the implantation site during surgery.

[0098] Various types of sheets that can be folded into tubing can be used to make the cut distal section. Further, various types of tubes can be cut into the desired pattern (one or more). For example, Nitinol and stainless steel and various other suitable metals known in the art can be used as the material of the sheet or tube.

[0099] While the above-described embodiment includes top teeth and side teeth such that each link 38 has three teeth total, other embodiments may include only one of the top teeth or the side teeth, or no teeth at all.

[0100] Figure 6 is a plan view of another exemplary laser cut sheet 30" for a distal section 25" of a delivery catheter. Figure 6 The distal section 25" is similar to Figure 5 The distal section 25 of the embodiment of the present invention, however, the joint 38 ″ of the distal section 25 ″ includes only the two side teeth 31 , 32 and their associated slots 34 , 35 , and does not include any top teeth or corresponding slots.

[0101] Figure 7 is a plan view of another exemplary laser cut sheet 30'" for a distal section 25'" of a delivery catheter. Figure 7 The distal section 25"' is also similar to Figure 5 2 , however, each joint 38 ′″ of the distal segment 25 ′″ includes only a single top tooth 33 and its associated slot 36 , and does not include any side teeth or corresponding slots.

[0102] In other embodiments, each link may include more or less than three teeth in any combination. Figure 6 and 7The teeth are shown arranged in straight rows along the length of the distal segments 25", 25'", respectively, but the laser cut sheets 30", 30'" can also be modified to include various tooth patterns and arrangements to enable the distal segments to bend in a particular desired shape, similar to that discussed above.

[0103] Various sheath and catheter designs can be used to effectively deploy the anchoring device at the implantation site. For example, for deployment at the mitral valve location, the delivery catheter can be shaped and / or positioned to point toward the commissure A3P3 so that the coil anchor deployed from the catheter can more easily enter the left ventricle and surround the chordae tendineae 62 during advancement. However, while the various exemplary embodiments of the present invention described below are configured to position the distal opening of the delivery catheter at the commissure A3P3 of the mitral valve, in other embodiments, instead, the delivery catheter can approach the plane of the mitral valve to point toward the commissure A1P1, and the anchoring device can be advanced through the commissure A1P1. In addition, the catheter can be bent clockwise or counterclockwise to approach the commissures of the mitral valve or the commissures of another desired native valve, and the anchoring device can be implanted or inserted in a clockwise or counterclockwise direction (e.g., the coils / turns of the anchoring device can be rotated clockwise or counterclockwise depending on how the anchoring device will be implanted).

[0104] In further embodiments, the catheter itself may also be positioned to pass below the plane of the native annulus and sit in one of the commissures or extend into the ventricle (e.g., through one of the commissures). In some embodiments, the distal end of the catheter may even be used to capture and / or surround some or all of the chordae tendineae 62. The catheter may be positioned in any suitable manner that allows the anchoring device to be deployed at the implantation site. In some embodiments, when the catheter is positioned at the implantation site, the catheter itself may have an atraumatic tip design, for example, to provide atraumatic access to the implantation site by reducing or eliminating any damage that could potentially be caused by advancement and / or shape manipulation of the catheter.

[0105] While several of the above-described embodiments of a distal section for a delivery catheter include teeth and corresponding slots, other embodiments of the distal section may not include teeth or corresponding slots. Fig.19is a perspective view of another exemplary distal segment 25"" that can be used for a delivery catheter. In this embodiment, the distal segment 25"" is a solid, generally cylindrical hollow tube made of a flexible material. The flexible material can be, for example, nitinol, steel and / or plastic, or any other suitable material or combination of materials that allows the distal segment 25"" to move to a flexed configuration when delivering an anchoring device. Although the example embodiments show the distal segment 25"" as a generally cylindrical tube, it should be understood that in alternative embodiments, the shape of the distal segment 25'" may take any suitable form capable of delivering an anchoring device. Some embodiments of the distal segment may include linear slits and / or rectangular windows.

[0106] Figure 8 A perspective view of a curved or "hockey stick" configuration of a distal section 65 of a delivery catheter 64 is shown. This configuration can be used to implant an anchoring device at a native valve (e.g., implanted at a native mitral valve using, for example, a transseptal technique). In the "hockey stick" configuration, the distal end 65 of the delivery catheter 64 extending from the transseptal sheath 20 has four major subsections: a first flexure section forming a shallow curved portion 66, a second flexure section forming a rounded or curved planar portion 67, a turn 68, and a flexible end portion 69. The shapes of these subsections allow the distal section 65 to guide the delivery catheter 64 into position at a native valve (e.g., a native mitral valve) and to accurately deploy the anchoring device at the native valve (e.g., at a mitral valve location). The distal section 65 can take any suitable form that allows the distal section to take the above-mentioned flexure configuration, such as, for example, any of the forms described in the present application. Although in the exemplary embodiment, the distal section 65 of the delivery catheter 64 curves in a clockwise direction, in other embodiments (e.g., Figures 9A-9U ), the distal segment 65 may instead be bent in an opposite, counterclockwise direction, for example, at a circular / curved planar portion 67 and / or a turn 68.

[0107] Figures 9A-9U Another exemplary embodiment of a delivery device (which may be the same or similar to other anchoring devices described herein) is illustrated, which delivers and implants an anchoring device (which may be the same or similar to other anchoring devices described herein) at a patient's native valve (e.g., at the patient's native mitral valve 50 using a transseptal technique). Fig.9A is a cross-sectional view of the left atrium of a patient's heart illustrating a sheath 20 (eg, an introducer sheath or a transseptal sheath) and a delivery catheter 64 extending from the sheath 20 crossing the atrial septum and into the left atrium, which may occur at the fossa ovalis (FO). Fig. 9BThe diagram illustrates a perspective of looking down at the mitral valve 50 from the left atrium 51 (i.e., from the Fig.9A The view taken by line BB in Fig.9A The transseptal sheath 20 and delivery catheter 64 are shown in the positions shown in FIG. Fig.9A , the sheath 20 is advanced into the left atrium such that the sheath is substantially parallel to the plane of the mitral valve 50. The sheath 20 and delivery catheter 64 may take any suitable form, such as, for example, any of the forms described herein.

[0108] In some embodiments, the sheath 20 can be actuated or manipulable so that the sheath 20 can be positioned or bent until it forms an angle (e.g., a 30 degree angle or about 30 degree angle) relative to the septum and / or FO wall. In some embodiments, the angular orientation (e.g., a 30 degree angle orientation) can be adjusted or controlled by rotating or further actuating the sheath 20, and the angular orientation can be adjusted to better control the orientation of the delivery catheter 64 into the left atrium. In other embodiments, the deflection angle of the sheath 20 relative to the septum and / or FO can be greater or less than 30 degrees, depending on each case, and in some applications, can even be oriented or bent at 90 degrees relative to the septum and / or FO. In certain embodiments, the deflection angle of the sheath can move between about 0 degrees and about 90 degrees, such as, for example, between about 5 degrees and about 80 degrees, such as between about 10 degrees and 70 degrees, such as between about 15 degrees and about 60 degrees, such as between about 20 degrees and about 50 degrees, such as between about 25 degrees and about 40 degrees, such as between about 27 degrees and about 33 degrees.

[0109] refer to Figures 9C-9D After the outer sheath or introducer sheath 20 passes through the septum and / or FO and is placed at the desired location, the delivery catheter 64 is removed from the sheath 20 and extended. The delivery catheter is controlled so that the delivery catheter includes a distal end 65 having a rounded or curved flat portion 67. In the illustrated embodiment, the distal end 65 of the delivery catheter 64 is moved so that the distal end 65 is bent in a counterclockwise direction to produce the rounded / curved flat portion 67 (the anchoring device may also be coiled in a counterclockwise direction). In alternative embodiments, the distal end 65 is moved so that the distal end 65 is bent in a clockwise direction to produce the rounded / curved flat portion 67 (in these embodiments, the anchoring device may also be coiled in a clockwise direction).

[0110] refer to Figures 9E-9F The delivery catheter 64 also extends downwardly through a shallow curved portion 66 at the distal end 65. Fig.9EAs shown, the delivery catheter 64 extends downward until the rounded / curved planar portion 67 of the distal end 65 is close to the plane of the mitral valve 50, which is generally about 30 to 40 mm below the FO wall. However, in some cases, the plane of the mitral valve can be less than 30 mm below the FO or greater than 30 mm below the FO. In some embodiments, the delivery catheter 64 is configured to extend 60 mm or less from the outer sheath, such as, for example, 50 mm or less, such as 45 mm or less, such as 40 mm or less, such as 35 mm or less, such as 30 mm or less, such as 25 mm or less, such as 20 mm or less. In some embodiments, the maximum extension of the delivery catheter 64 from the outer sheath is between about 20 mm and about 60 mm, such as, for example, between about 25 mm and about 50 mm, such as between 30 mm and about 40 mm. In some embodiments, the delivery catheter 64 can be moved to any of the various configurations described herein by engaging one or more actuation points 70, 71 of the delivery catheter 64.

[0111] The rounded / curved planar portion 67 is advanced or lowered to be located near, at the top, or substantially at the top of the plane of the mitral valve 50. When lowered to the level of the annulus or close to the level of the annulus, the planar portion 67 or the plane of the planar portion 67 can be parallel or nearly parallel to the plane of the annulus (e.g., planar or nearly planar), or the planar portion 67 can be slightly angled upward relative to the plane of the annulus. The delivery catheter 64 is also bent to loop back toward the commissure A3P3. The delivery catheter 64 can be moved in any suitable manner, such as, for example, pulling on a wire and ring system, or any other suitable method including those described elsewhere in this application, to produce the rounded / curved planar portion 67 and / or the shallow curved portion 66. Although the illustrated embodiment shows moving the distal end 65 to produce the circular or curved planar portion 67 before moving the distal end to produce the shallow curved portion 66, it should be understood that extending the distal end 65 downward to produce the shallow curved portion 66 can occur before the distal end 65 is bent in a counterclockwise direction to produce the circular or curved planar portion 67.

[0112] refer to Figure 9G-9H, the actuation point 70 (and / or one or more other actuation points) can be located between the shallow curved portion 66 and the rounded / curved planar portion 67 that allows the distal segment 65 to be adjusted. In an example embodiment, the actuation point 70 can be adjusted so that the planar portion 67 and the flexible tip 69 are angled in a slightly downward direction so that the flexible tip 69 and the distal tip 907 extend below the annulus (or below the upper plane of the annulus) in the direction of the commissures A3P3 of the mitral valve 50 and / or enter the commissures A3P3 of the mitral valve 50. That is, the first actuation point 70 can be actuated so that the planar portion 67 (and therefore the flexible tip 69) is angled downward toward the commissures A3P3 and positioned at or near (e.g., extends slightly into or through, such as 1-5 mm or less) the commissures. In addition to or alternatively to the further actuation point 70, the delivery device (e.g., sheath and / or delivery catheter) can be twisted or rotated to angle the rounded / curved planar portion 67 downwardly toward and / or into the commissures as desired. Such twisting or rotation may sometimes be necessary to correct the angle if actuation of the curvilinear portion does not fully position the distal region of the catheter as desired. In some embodiments, a second actuation point 71 may be located between portion 67 and the flexible tip 69.

[0113] Fig.9I A delivery catheter 64 is illustrated that deploys an exemplary embodiment of an anchoring device 1 through commissures A3P3 and around chordae tendineae 62 and native leaflets in a left ventricle 52 of a patient's heart. The lower end or encircling coil / turn of the anchoring device 1 or an anchoring device having a larger diameter or radius of curvature exits the distal opening of the delivery catheter 64 and begins to assume its shapeset or shape memory form in the direction of the circular or curved planar portion 67 of the delivery catheter 64.

[0114] In order to move the anchoring device 1 through the commissures A3P3 of the mitral valve 50, the delivery catheter 64 is positioned such that the circular / curved planar portion 67 and the distal opening of the flexible tip 69 of the delivery catheter 64 are angled downward, and the distal opening of the flexible tip 69 is oriented downward toward and / or into the commissures A3P3. Since the circular / curved planar portion 67 and the distal opening of the flexible tip 69 are in a downward direction, the anchoring device 1 exits the delivery catheter 64 in a downward direction. After the anchoring device 1 exits the delivery catheter 64, the anchoring device 1 begins to bend to assume its shape-set or shape-memory form. Fig.9I As shown in the example, because the rounded / curved planar portion is angled in the downward direction, the anchoring device is deployed approximately 1 After 2 turns, the anchoring device 1 begins to bend in an upward direction. To prevent the anchoring device 1 or the lower end / surrounding coil / turn from engaging the mitral valve 50 in an upward direction when it is delivered out of the delivery catheter 64 (e.g. Fig.9I Once the anchoring device has been initially wrapped around the chordae tendineae 62, the delivery catheter 64 can be moved (e.g., by moving at the actuation point 70) such that the circular / curvilinear planar portion 67 is substantially parallel to the plane of the mitral valve 50 (see Figure 9L This may be accomplished by actuating and / or twisting or rotating the delivery device or a portion thereof (eg, a delivery catheter) at point 70 to adjust the angle of planar portion 67 as desired.

[0115] refer to Figure 9J After the rounded / curved planar portion 67 is moved to be substantially planar with the mitral annulus, the anchoring device 1 can be further deployed from the delivery catheter 64 such that the anchoring device is wrapped around the chordae tendineae 62 in a position substantially parallel to the plane of the mitral valve 50. This prevents the anchoring device from bending in an upward direction and engaging the underside of the mitral annulus and / or the top wall of the left ventricle.

[0116] refer to Figure 9K , the anchoring device 1 is arranged around the chordae tendineae 62 to loosely position the anchoring device on the ventricular side of the mitral valve for holding the heart valve. In an exemplary embodiment, the anchoring device 1 is arranged in the left ventricle 52 so that the three functional coils 12 of the anchoring device are tightly wrapped around the chordae tendineae and / or the native leaflets. It can be seen that the lower end turns / coils or the surrounding turns / coils extend slightly outward due to their larger radius of curvature. In some embodiments, the anchoring device 1 may include less than three coils 12 or more than three coils 12 arranged around the chordae tendineae and / or leaflets.

[0117] Figure 9L The left atrium 51 is shown with the coil 12 of the anchoring device arranged around the chordae tendineae 62 and the native leaflets (eg, Figure 9K ). In this position, the rounded / curved planar portion 67 of the delivery catheter 64 is substantially parallel to the plane of the mitral valve 50, and the flexible tip 69 is located at or near (e.g., extending slightly into or through, such as 1-5 mm or less) the commissures A3P3 of the mitral valve 50.

[0118] refer to Figure 9M ,like Figure 9K-9LAs shown in , after the delivery catheter 64 and the anchoring device 1 are positioned, the delivery catheter is translated or retracted axially along the anchoring device in the X direction and into the outer sheath 20. The translation or retraction of the delivery catheter can cause a portion of the anchoring device positioned on the atrial side of the native valve (e.g., in the atrium) to be unsheathed and released from the delivery catheter. For example, this can cause any functional coil and / or any upper portion of the upper coil positioned on the atrial side of the native valve (if any) to be unsheathed and released. In an exemplary embodiment, the anchoring device 1 does not move or substantially does not move when the delivery catheter is translated, for example, a pusher can be used to hold the anchoring device in place and / or inhibit or prevent the anchoring device from retracting when the delivery catheter is retracted.

[0119] refer to Figure 9N In the illustrated example, translation or retraction of the delivery catheter may also cause any upper end coil / turn (e.g., a larger diameter stabilizing coil / turn) of the anchoring device 1 to be unsheathed / released from the delivery catheter. Due to the unsheathing / release, the atrial side or upper coil (e.g., a stabilizing coil with a larger diameter or radius of curvature) of the anchoring device extends away from the delivery catheter 64 and begins to assume its preset or relaxed shape setting / shape memory shape. The anchoring device may also include an upwardly extending portion or connecting portion that extends upward from the bend Z and may extend and / or bridge between the upper end stabilizing coil / turn and other coils / turns (e.g., functional coils / turns) of the anchoring device. In some embodiments, the anchoring device may have only one upper coil on the atrial side of the native valve. In some embodiments, the anchoring device may include more than one upper coil on the atrial side of the native valve.

[0120] refer to Fig.9O The delivery catheter 64 continues to translate back into the outer sheath or guide sheath 20, which causes the upper portion of the anchoring device 1 to be released from the interior of the delivery catheter. The anchoring device is attached by means such as suture / thread 901 (can also be used). Figures 17A-18C Other attachment or connection means in the anchoring device 1) are tightly connected to the pusher 950. The upper end coil / turn or stabilizing coil / turn is shown to be arranged along the atrial wall to temporarily and / or loosely maintain the position or height of the anchoring device 1 relative to the mitral valve 50.

[0121] refer to Figure 9P, the anchoring device 1 is completely removed from the lumen of the delivery catheter 64, and slack is shown in the suture / thread 901 removably attached to the anchoring device 1, for example, the suture / thread 901 can be looped through the eyelet at the end of the anchoring device. In order to remove the anchoring device 1 from the delivery catheter 64, the suture 901 is removed from the anchoring device. However, before removing the suture 901, the position of the anchoring device 1 can be checked. If the position of the anchoring device 1 is incorrect, the anchoring device can be pulled back into the delivery catheter and redeployed by a pusher 950 (e.g., a push rod, a push wire, a push tube, etc.).

[0122] refer to Figure 9Q , after the delivery catheter 64 and outer sheath 20 are detached from the anchoring device 1, the heart valve delivery device / catheter 902 can be used to deliver the heart valve 903 to the mitral valve 50. The heart valve delivery device 902 can utilize one or more components of the delivery catheter 64 and / or outer sheath or guide sheath 20, or the delivery device 902 can be independent of the delivery catheter 64 and outer sheath or guide sheath. In an exemplary embodiment, the heart valve delivery device 902 utilizes a trans-septal approach to enter the left atrium 51.

[0123] refer to Figure 9R , the heart valve delivery device / catheter 902 is moved through the mitral valve 50 so that the heart valve 903 is placed between the leaflets of the mitral valve and the anchoring device 1. The heart valve 903 can be guided along the guidewire 904 to the deployment position.

[0124] refer to Figure 9S , after the heart valve 903 is placed in the desired position, the optional balloon is expanded to expand the heart valve 903 to its expanded, deployed size. That is, the optional balloon is inflated so that the heart valve 903 engages the leaflets of the mitral valve 50 and forces the ventricular turns outward to an increased size to secure the leaflets between the heart valve 903 and the anchoring device. The outward force of the heart valve 903 and the inward force of the coil 1 can clamp the native tissue and hold the heart valve 903 and the coil to the leaflets. In some embodiments, the self-expanding heart valve can be maintained in a radially compressed state within the sheath of the heart valve delivery device 902, and the heart valve can be deployed from the sheath, which expands the heart valve to its expanded state. In some embodiments, a mechanically expandable heart valve is used, or a partially mechanically expandable heart valve (e.g., a valve that can be expanded by a combination of self-expansion and mechanical expansion) is used.

[0125] refer to Figure 9T After the heart valve 903 is moved to its expanded state, the heart valve delivery device 902 and the wire 904 (still in Figure 9T) is removed from the patient's heart. The heart valve 903 is in a functional state and replaces the function of the mitral valve 50 of the patient's heart.

[0126] Figure 9U Shows along Figure 9T The line UU in FIG. 9 is a view of the heart valve 903 in the left ventricle 52 from an upward perspective. Figure 9U , the heart valve 903 is in an expanded and functional state. In an example embodiment, the heart valve 903 includes three valve components 905a-c (e.g., leaflets) configured to move between an open position and a closed position. In an optional embodiment, the heart valve 903 may have more than three or less than three valve components configured to move between an open position and a closed position, such as, for example, two or more valve components, three or more valve components, four or more valve components, etc. In an example embodiment, the valve components 905a-c are shown in a closed position to prevent blood from moving from the left ventricle and entering the left atrium, and the closed position is the position of the valve components during systole. During diastole, the valve components 905a-c move to an open position, which allows blood to enter the left ventricle from the left atrium.

[0127] Although Figures 9A-9U The illustrated embodiment shows a delivery catheter 64 delivering the anchoring device 1 through the commissure A3P3, but it should be understood that the delivery device 64 can take a configuration and be positioned to deliver the anchoring device 1 through the commissure A1P1 so that the anchoring device 1 can be wrapped around the chordae tendineae in the left ventricle of the patient's heart. In addition, although the illustrated embodiment shows a delivery catheter 64 delivering the anchoring member 1 to the mitral valve and a heart valve delivery device 902 delivering the heart valve 903 to the mitral valve 50, it should be understood that the anchoring device 1 and the heart valve 903 can be used to repair the tricuspid valve, the aortic valve, or the pulmonary valve.

[0128] In one embodiment, the distal section 65 of the delivery catheter 64 can be a solid, generally cylindrical hollow tube (e.g., Fig.19 The distal section 25"" described above).

[0129] The guide sheath and / or distal section of the various delivery catheters herein may include one or more pull wires (e.g., 2-6 pull wires) to control or actuate the delivery catheter to a desired configuration. For example, the distal section of the various delivery catheters herein may have a dual pull wire system (e.g., Figure 20A-23 For example, Figures 9A-9U The configuration shown in Figure 8The "hockey stick" shaped configuration shown in or any other configuration described in the present application can also be achieved by utilizing a flexible tube catheter configured with two positioned pull rings, the positioned pull rings being at or near the actuation points 70, 71 described above, for example. The pull rings can be engaged or connected with corresponding pull wires. The pull wires can be positioned 90° away from each other in the circumferential direction around the delivery catheter. For example, a first pull ring positioned roughly halfway along the distal section 65 can be actuated by a first pull wire to pull the distal region of the delivery catheter to the natural valve plane (e.g., mitral valve plane), while a second pull ring positioned further distally - at or near the distal tip 907 of the delivery catheter - can be actuated by another pull wire to allow the catheter to be bent in different directions, for example, around the natural valve plane (e.g., around the mitral valve plane) and toward the desired commissure (e.g., mitral valve commissure A3P3), and further if necessary.

[0130] In some embodiments, the two pull rings can be connected by a ridge that is implemented on the radially opposite side of one of the pull wires, for example, opposite the pull wire of the farthest pull ring. Such added ridges can limit the relative movement between the pull rings and help better control the deflection direction caused by pulling the pull wire of the farthest pull ring, and prevent the flexible distal section from deflecting in a direction perpendicular to the plane of the mitral valve or in other unintended directions. Although the above-mentioned embodiments may include three pull rings and two pull wires, it should be understood that any number of pull rings and / or pull wires can be used to produce the various structures described herein. In addition, it should be understood that any suitable number of ridges can be used to limit the relative movement between the pull rings.

[0131] In some embodiments, the distal segment 65 may be a laser cut hypotube arranged in such a pattern (similar to the above Figure 4-7 ), such that when bent, the distal segment forms any of the various configurations described herein (e.g., Figures 9A-9U , "hockey stick configuration," etc.). Also as discussed, such a laser-cut distal segment can have two or more actuation points that can be actuated independently of each other, e.g., by separate pull wires, e.g., controlled by separate controls (e.g., knobs, tabs, inputs, buttons, levers, switches, etc.) or other mechanisms to achieve bidirectional deflection of the distal end in a fully curved configuration (e.g., one curve toward the plane of the mitral valve and the other curve being a circular portion that curves generally around the mitral annulus).

[0132] In some embodiments, the entire distal segment 65 does not need to be constructed as a laser-cut hypotube. For example, the distal segment 65 may include a first flexible straight segment adjacent to a shallow curved portion 66, an optional small laser-cut elbow portion that constitutes a shallow curved portion 66 to help the most distal region of the catheter bend to the mitral valve plane, and a second flexible segment extending to the distal tip, with the ability to bend along the mitral valve plane to point the end of the catheter to the commissure A3P3. The first flexible segment allows the distal segment 65 to approach the mitral valve plane after leaving the transseptal sheath 20, and is flexible enough to be pushed and pushed through the sheath 20, but still rigid enough to resist the impact of the anchoring device when the anchoring device is pushed and delivered through the catheter. The first flexible segment can be constructed, for example, with a hardness of about 50D, coated on a coiled or braided tube. At the same time, the small laser-cut elbow portion can have a maximum deflection of about 150° to assist the distal region of the catheter in bringing it to the mitral valve plane. Finally, similar to what has been discussed above, the second flexible section can extend to the distal tip of the delivery catheter and be configured to flex to direct the catheter toward the commissure A3P3, and potentially flex further to assist the anchoring device in wrapping around the chordae. The second flexible section can also be constructed, for example, with PEBAX, which has a hardness of about 55D, for example, and is also reflowed over the coiled or braided tube. With this construction, a distal section 65 that is shaped and actuated substantially similar to the laser cut hypotube described above can still be obtained without having to form the entire distal section 65 as a laser cut hypotube, or any portion of a laser cut hypotube.

[0133] Although the delivery catheter 64 with the distal section 65 has been described using the above embodiments, it should be understood that the above embodiments are exemplary only. The delivery catheter 64 can take any suitable form that can produce the shape configuration described herein. In addition, the delivery catheter can be constructed with any suitable material that can produce the shape configuration described herein.

[0134] Fig.10 A perspective view of an exemplary distal section 75 of a delivery catheter 74 (which may be the same or similar to other delivery catheters described herein) for implanting an anchoring device (which may be the same or similar to other anchoring devices described herein) at a native valve is shown. For the mitral valve, this may be accomplished using a transseptal technique. The delivery catheter is shown as an example assuming a helical configuration. Unlike a "hockey stick" configuration, and similar to Figures 9A-9UIn the configuration discussed, the sheath 20 extends through the FO in a direction parallel to the plane of the native annulus (e.g., the mitral valve plane). In this embodiment, the distal segment 75 then leaves the sheath 20 and extends downwardly about one spiral to the commissure A3P3 of the mitral valve. The shape of the distal segment 75 can be configured to be spiral, wherein the distal end of the catheter can initially extend below the plane of the native annulus during deployment. The user can then adjust the height of the distal end, for example by applying an upward pull on a flexible wire integrated into or attached to the catheter, so that the distal end is placed in the plane of the native annulus of the patient's heart or just above the plane of the native annulus of the patient's heart.

[0135] In some embodiments, the distal section 75 can be a fully laser cut hypotube (similar to the Figure 4-7 ), wherein the cuts are arranged in a pattern such that when bent, the distal segment forms a helical configuration. In some embodiments, the shape of the helical configuration allowing the laser cut hypotube to be formed is a helix that stretches or extends to the plane of the native annulus (e.g., stretches or extends from the FO to a position below the mitral valve). The corresponding gaps between the top teeth and their associated slots (e.g., the slots are radially wider than the teeth, thereby providing space for the teeth to move radially when the teeth are in their corresponding slots) allow the catheter to be stretched vertically. The shape of the distal segment can be set with this vertical stretch configuration. Then, when the spiral is in the mitral valve anatomy, the distal tip of the catheter can be pulled upward to position it along the mitral valve plane or just above the mitral valve plane, for example by flexing or tightening a flexible wire in the distal segment of the catheter discussed above or otherwise attached to the distal segment. This feature allows the spiral to be adjusted to varying heights to accommodate different patient anatomies.

[0136] In another embodiment of a delivery catheter 74 with a spiral configuration, the distal section 75 may not be constructed as a laser cut hypotube, but may be formed as a coated coil instead. For example, the catheter may be formed by a tube braided or coiled with, for example, a low durometer PEBAX coated above it, about 55D hardness. When flexed, the catheter may be similar to the formation of a spiral configuration discussed above. At the same time, in order to control the height of the spiral, a pusher wire extending along the axis of the delivery catheter and optionally connected to the distal end of the catheter may be included. The pusher wire has sufficient strength and physical properties to allow the distal end of the catheter to be pushed and / or pulled onto the natural annular plane (e.g., mitral valve plane). For example, the pusher wire may be a NiTi wire, a steel wire or any other suitable wire. In one embodiment, when the distal end is below the natural annular plane (e.g., below the mitral valve plane), the pusher wire pushes the distal end of the spiral and pulls back the pusher wire to lift the distal end of the delivery catheter.

[0137] In another embodiment utilizing a delivery catheter 74 having a helical configuration, the distal segment may not be laser cut or otherwise not cut at all (e.g., similar to Fig.19 For example, the distal section 75 of the delivery catheter 74 can be formed from a flexible tubing catheter constructed with pull loops, pull wires, and / or ridges configured to move the delivery catheter 74 into a helical configuration.

[0138] Although the above embodiment is used to describe the delivery catheter 74 having the distal section 75, it should be understood that the above embodiment is only exemplary. The delivery catheter 74 can take any suitable form that can produce a spiral configuration. In addition, the delivery catheter can be constructed of any suitable material that can produce a spiral configuration (for example, the distal section 75 can be made of Figure 20A-23 , such as in the form of a delivery catheter 114 shown in ).

[0139] Fig.11 A stereoscopic view of a hybrid configuration of a distal section 105 of a delivery catheter 104 is shown. The delivery catheter 104 combines features from both the "hockey stick" and spiral configurations described above. In the hybrid configuration, similar to the "hockey stick" configuration, the distal section 105 of the delivery catheter 104 initially has a shallow curved or bent portion 106 to bend the catheter 104 toward the plane of the mitral valve. In an optional embodiment, the catheter 104 is bent by increasing the proximal flexure of the curved portion 106. The shallow curved portion may be followed by a circular or curved planar portion 107 that begins to bend, for example, in a counterclockwise direction as shown. In other embodiments, the delivery catheter 104 may instead bend or curve in a clockwise direction (e.g., as shown in FIG. 1 ). Figure 8 ). The planar portion 107 may be substantially parallel to the mitral valve plane.

[0140] Meanwhile, distal to the planar portion 107 is a flexible tip portion 108, which can be bent, angled, or otherwise directed slightly downward out of the plane in which the planar portion 107 is disposed to more effectively direct the distal opening of the delivery catheter 104 toward or through the commissure or other target. In some embodiments, the flexible tip portion 108 can form a downward spiral region of the delivery catheter 104. The flexible tip portion 108 can be deflected or displaced in a vertical direction from the planar portion 107, for example, between about 2 mm and about 10 mm, such as between about 3 mm and about 9 mm, such as between about 4 mm and about 8 mm, such as between about 5 mm and about 7 mm, such as about 6 mm. In other embodiments, the vertical displacement can be about 2 mm or more, such as about 3 mm or more, such as about 4 mm or more, such as about 5 mm or more, such as about 6 mm or more, such as about 7 mm or more, such as about 8 mm or more, such as about 9 mm or more, such as about 10 mm. Furthermore, in some embodiments, the flexible end portion 108 (ie, the downward spiraling section) can begin substantially from the curved portion 106 such that only a small portion, or even no portion, of the distal section 105 of the delivery catheter 104 extends in a plane substantially parallel to the plane of the mitral valve.

[0141] As with the aforementioned delivery catheters, the distal section 105 of the delivery catheter 104 may be made of or include: laser cut hypotube, braided or coiled tube catheter, flexible tube without incision or other flexible tubular structures. In some embodiments, the distal section 105 of the catheter 104 may be coated with PEBAX, for example. In addition, the distal end 105 of the delivery catheter 104 may be actuated or manipulated, for example, by shape setting, pulling wires and / or pull rings, ridges, and / or utilizing various other methods or features described in the present application.

[0142] Meanwhile, although in the above-described embodiments the delivery device is generally or mostly positioned above the plane of the native valve ring (e.g., the plane of the mitral valve), and the anchoring device is extruded from the delivery device, but remains on the atrial side or just slightly beyond it (e.g., 1-5 mm or less), and is pushed into the ventricle (e.g., through the commissures of the native valve), in some other embodiments, at least a portion or a substantial portion of the delivery device itself may also be positioned in the left ventricle. For example, Fig.12 A delivery device for installing an anchoring device 1 at the native mitral valve using a transseptal technique is shown, wherein much of the distal end of the delivery device itself (eg, the curved or actuatable portion) is also advanced through the native mitral valve and into the left ventricle.

[0143] refer to Fig.12, the delivery device shown includes an outer guide sheath 20 and a flexible delivery catheter 114 that can be advanced through and out of the distal end of the guide sheath 20. In the embodiment shown, for example, Fig.12 As shown in , the introducer sheath 20 can first be manipulated through an opening formed in the atrial septum (e.g., at the fossa ovalis) and into the left atrium. The introducer sheath 20 can then be manipulated to curve or bend downward toward the native mitral valve annulus so that the distal opening of the introducer sheath 20 is substantially coaxial with the central axis of the mitral valve annulus. The vertical position of the introducer sheath 20 can be such that the distal opening of the introducer sheath 20 is substantially aligned with the native mitral valve annulus, or can be positioned in the left atrium, slightly above the native mitral valve annulus, or in some embodiments (e.g., Fig.12 ), can extend through the native mitral valve annulus and into the left ventricle.

[0144] Once the guide sheath 20 is substantially Fig.12 The delivery catheter 114 is then advanced out of the distal opening of the guide sheath 20, positioned as shown. In this embodiment, the distal end of the guide sheath 20 is positioned at or slightly above the native mitral valve annulus, so that the delivery catheter 114 can be first advanced into the left atrium, just above the native mitral valve annulus. The delivery catheter 114 can initially be advanced out of the distal opening of the guide sheath 20 in an unactuated, substantially straight configuration, and can thereafter be actuated to a position after being advanced out of the guide sheath 20. Fig.12 In some embodiments, delivery catheter 114 can be actuated into any other suitable configuration, such as, for example, any configuration described herein.

[0145] The flexible delivery catheter 114 may include two or more main deflectable sections, for example, a distal section 115 that can be bent into a curved configuration, which is relatively wide and rounded in shape to assist in shaping the anchoring device 1 as it is advanced out of the delivery catheter 114 and delivered to the implantation site, and a more proximal section 116 that forms a sharper bend (e.g., a bend of approximately 90 degrees) to assist in positioning the distal section 115 in a plane that is substantially coplanar or parallel to the plane of the native annulus (e.g., the plane of the mitral valve). The delivery catheter 114 may take any suitable form, such as, for example, any of the forms described herein.

[0146] refer to Figure 13-16 In one exemplary embodiment, the distal region 117 of the exemplary delivery catheter 114 can be constructed of a hypotube having a first series of slots 125 and a second series of slots 126. The delivery catheter can also have a pull wire system (e.g., a dual pull wire system including a first pull wire 135 and a second pull wire 136). Fig.13A schematic side view of a distal section 117 of an exemplary embodiment of a delivery catheter 114 is shown. Fig.14 A cross-sectional view of a multi-lumen extrusion portion of a delivery catheter 114 is shown, the cross section being taken in a plane perpendicular to the longitudinal axis of the delivery catheter, and Fig.15 and 16 Shown in partially and fully actuated states Fig.13 Schematic perspective view of the delivery catheter 114. For example, as shown in any of the embodiments discussed above, other delivery catheters deployed and used in different ways can also be constructed with a similar dual pull wire system.

[0147] In one embodiment, the delivery catheter 114 has a distal region 117 including two flexible sections 115, 116. A first series of slots 125 can be arranged (e.g., linearly arranged or otherwise arranged) along a first side of the distal region 117 corresponding to and providing flexibility to the first flexible section 115, such that when the delivery catheter is actuated, the first flexible section 115 can form a generally circular configuration (e.g., which can be similar to Fig.12 The second series of slots 126 may be arranged linearly along a second side of the distal region 117 corresponding to the second flexible section 116 and providing flexibility to the second flexible section 116, so that when the delivery catheter 114 is actuated, the second flexible section 116 may form a Fig.12 . The slots 125, 126 may be laser cut or formed in a manner similar to that described in the previous embodiments, or may be formed in a variety of other ways, as long as the slots 125, 126 cause the delivery catheter 114 to be shaped as desired after actuation. The second series of slots 126 are positioned slightly adjacent to the first series of slots 125 corresponding to the bending positions of the segments 115, 116, and may be offset in the circumferential direction, for example, by about 90 degrees around the distal region 117, to allow two orthogonal bends in the region, wherein the respective radii of curvature and articulation directions of the segments 115, 116 may be different from each other. In some embodiments, the segments 115, 116 may be offset in the circumferential direction, for example, between about 65 degrees and about 115 degrees, such as between about 75 degrees and about 105 degrees, such as between about 80 degrees and about 100 degrees, such as between about 85 degrees and about 95 degrees.

[0148] In certain embodiments, each of the segments 115, 116 may have an associated pull wire 135, 136 for controlling the bending of the segments 115, 116, respectively. The pull wire 135 may extend distally through the slot 125 and may be attached to the distal region 117 at a connection point 135a and / or a pull ring, for example, by welding or other attachment means. Similarly, the pull wire 136 may extend distally through the slot 126 and may be welded or otherwise attached to the distal region 117 at a connection point 136a and / or a pull ring.

[0149] Meanwhile, proximal to the distal region 117, the delivery catheter 114 may include a proximal section 140 that may be formed as a braided multilumen tube extrusion. Fig.14 As shown in the cross-section of FIG. 1 , the proximal section 140 of the delivery catheter 114 can have one or more central lumens through which pull wires 135, 136 extend to reach the distal region 117. As previously described, the pull wires 135, 136 can be arranged to extend side by side through the central region of the proximal section 140, and can then exit distally from the proximal section 140 and be attached to the sidewalls of the distal region 117. When the pull wires 135, 136 are used, the pull wires 135, 136 provide an anti-whipping or anti-bending effect through the delivery catheter 114 by the central positioning of the proximal section 140, allowing the delivery catheter 114 to maintain full torsionability. However, in some embodiments, the pull wires are not centrally positioned, but extend from one end to the other along the sidewall or outer wall.

[0150] In addition, the proximal segment 140 may have a main lumen 141. In the case where the pull wire is not located in the center, the main lumen may be located in the center. Optionally, for example, when the pull wire is located in the center, the main lumen 141 may be offset from the center of the extruded structure. The main lumen 141 is sufficiently sized to allow the anchoring device to pass through and be delivered through the main lumen 141. The main lumen 141 may have, for example, an oval cross-section, a circular cross-section, or a cross-section of any other suitable shape, as long as the anchoring device 1 can be effectively advanced through it. In addition to the main lumen, for example, in order to achieve (affect) a symmetrical moment of inertia around the pull wire passing through the proximal segment 140, a plurality of optional parallel dummy lumens may also be formed in the proximal segment 140 and extend longitudinally through the proximal segment 140. In the illustrated embodiment, the first dummy lumen 142 is optionally located diametrically opposite to the main delivery lumen 141 and forms a shape substantially the same as the main lumen 141 (e.g., an oval shape in the illustrated embodiment). In addition, there are two optional false cavities 143 positioned relative to each other in diameter and circumferentially positioned between cavities 141 and 142. The additional false cavities 143 are exemplified as being slightly smaller than cavities 141, 142 and having a more circular shape. In practice, the size and shape of the false cavities 143 can vary in other ways, and will generally be selected based on the corresponding sizes of cavities 141, 142 and the amount of space remaining in the extruded structure. In addition, the main cavity 141 and the first false cavity 142 may also have variable sizes and shapes, depending on the specific application. In addition, in some other embodiments, more or less than four total cavities may be formed in the proximal segment 140 to achieve the desired symmetry and moment of inertia and to uniformly provide stiffness around the pull wire extending through the central axis of the proximal segment 140.

[0151] Reference again Figure 2B , 9A -9N and 12, in practice, once the guide sheath 20 is arranged or positioned as desired (e.g., as shown or described elsewhere herein, for example, across the septum in a mitral valve procedure), a distal region of the delivery catheter (e.g., distal region 117 or any other distal region described herein), and in some embodiments, a portion of the proximal segment (e.g., proximal segment 140) is advanced out of the distal opening of the guide sheath 20. Prior to adjusting the delivery catheter to its actuated configuration or final actuated configuration, the portion of the delivery catheter (e.g., catheter 114) extending away from the guide sheath 20 may be positioned in the left atrium. In some cases, a portion of the delivery catheter may also be extended through the native mitral valve prior to the delivery catheter being adjusted to its actuated configuration or final actuated configuration (e.g., as Fig.12The pull wires 135, 136 may then be tightened to actuate the distal region 117 and obtain articulation of the two bends in the segments 115, 116 at the distal portion of the delivery catheter 114, for example. For example, in one sequence, as Fig.15 As shown in , the second pull wire 136 can be first tightened to bend the segment 116 and place the portion of the delivery catheter 114 distal to the segment 116 substantially in plane and / or parallel to the native valve annulus. Fig.16 As shown in , the first pull wire 135 can then be tightened to bend segment 115 into its circular or curvilinear actuated state such that the curvature of segment 115 is substantially planar and / or parallel to the native valve annulus (e.g., to the plane of the mitral valve). In other embodiments, the pull wires 135, 136 can be partially or fully tightened in different amounts and / or sequences to properly and safely guide around the patient's anatomy during actuation. For example, segment 115 can be actuated and bent to form a circular or curvilinear planar portion (e.g., similar to planar portion 67) (e.g., as described with respect to FIG. 1 ) before actuating or bending segment 116 so that the curvilinear planar portion or segment 115 is lowered and / or appropriately angled. Figures 9A-9U After these actuation steps, in one embodiment, the distal region 117 of the delivery catheter 114 may be positioned completely or mostly in the left atrium or on the atrial side of the native valve.

[0152] In some cases, actuating only the curved region of the delivery catheter may not be sufficient to properly position the distal tip at or near the commissure in the desired delivery location, and twisting or rotating the delivery device or portion thereof (e.g., rotating the delivery catheter and / or guide sheath) may be used to angle the delivery catheter and the tip of the delivery catheter as needed. For example, after the distal region 117 of the delivery catheter 114 is fully actuated or bent as needed (e.g., as described above), the assembly may be twisted and rotated to angle the tip of the delivery catheter 114 or align at or enter the commissure of the native valve, for example, at the commissure A3P3 of the mitral valve. The delivery catheter 114 may then be further twisted and rotated so that the distal tip of the delivery catheter 114 passes through the commissure and enters the left ventricle. Optionally, further rotation and / or actuation of the delivery catheter 114 can then facilitate circumferential advancement of the distal tip of the delivery catheter 114 into the left ventricle to loop or position around the exterior of mitral valve anatomy, such as chordae tendineae, papillary muscles, and / or other features in the left ventricle. The design of the proximal section 140 and the central arrangement of the pull wires 135, 136 help provide an anti-whipping or anti-bending effect through the delivery catheter 114 when the pull wires 135, 136 are manipulated, allowing full torquability of the delivery catheter 114 through the trans-septal bend to be maintained, and facilitating more effective retention and maintenance of the actuated shape of the distal region 117 during this rotation step.

[0153] refer to Fig.12 If the user chooses to move the distal region of the catheter into a ventricle (e.g., the left or right ventricle), the movement of the delivery catheter 114 around the anatomical structures in the ventricle can be used to gather or capture the corralled anatomical structures within the bend of the distal region 117. In some embodiments, after the distal region 117 of the delivery catheter 114 is moved to a desired position around the chordae and other features in the ventricle, the first pull wire 135 can still be further tightened to reduce the radius of curvature of the circular segment 115 to cinch and gather the chordae and other native anatomical structures passing through the center of the circular segment 115, or even further toward the center of the native annulus. This radial tightening or gathering of the native anatomical structures in the ventricle can then help facilitate a more robust delivery of the anchoring device 1 - for example, by making it easier to advance the anchoring device 1 around the gathered chordae and other features.

[0154] After the delivery catheter 114 has been satisfactorily positioned around the chordae tendineae and other desired anatomical structures in the left ventricle, the anchoring device 1 can be advanced outside the distal opening of the delivery catheter 114. The curved shape of the circular segment 115 can facilitate smoother and easier extrusion of the anchoring device 1 from the delivery catheter 114, because the curvature of the circular segment 115 can be formed to substantially approximate the final curvature of the anchoring device 1. In addition, the initial looping of the distal region 117 around at least a portion of the desired mitral valve anatomy in the left ventricle can facilitate easier delivery of the anchoring device 1 outside and around the same anatomical structure that has been surrounded. Once the ventricular portion of the anchoring device 1 has been advanced to the desired location in the left ventricle, the atrial portion of the anchoring device 1 can be released from the delivery catheter 114 in a manner similar to one of the various manners discussed above—for example, by axially translating the delivery catheter 114 backward. Such translation of the delivery catheter 114 can also help the delivery catheter 114 itself to retract out of the left ventricle and back into the left atrium. Then, after the anchoring device 1 has been fully delivered to and moved to the desired location, the tension in the pull wires 135, 136 can be released and the delivery catheter 114 can be straightened and retracted through the introducer sheath 20. Thus, similar to what was previously discussed, a prosthesis (e.g., a THV or other prosthetic valve) can be advanced into and expanded in the anchoring device 1.

[0155] Figures 20A-20E , 22 and 23 illustrate exemplary embodiments of delivery catheters that can operate in the same or similar manner as the delivery catheters 64, 114 described above. Any components, mechanisms, functions, elements, etc. (e.g., steering or actuation mechanisms or pull wire systems, pull wires, rings, ridges, etc.) of this embodiment can be incorporated into other delivery catheters (and even guide sheaths) described herein. Figures 20A-20E , 22 and 23, the distal region 117 of the delivery catheter 114 may be constructed of a flexible tube 2030 (e.g., which may be connected to Fig.19 The delivery catheter may be the same or similar to the flexible tube 25"" shown in or other tubes described herein). The delivery catheter has a steering / actuating mechanism or pull wire system that can be used to actuate and bend the distal region of the catheter. The steering / actuating mechanism or pull wire system herein may have one or more pull wires (e.g., 1-6 or more pull wires), one or more rings or pull rings (e.g., 1-7 or more rings), one or more ridges and / or other components.

[0156] In an exemplary embodiment, the delivery catheter has a dual pull wire system including a first pull wire 2035 , a second pull wire 2036 , three rings or pull loops (ie, a first ring 2037 , a second ring 2038 , a third ring 2039 ), a first ridge 2040 , and a second ridge 2041 . Fig. 20AAn end view of the distal section 117 of the delivery catheter 114 is shown. Fig. 20C It is taken along the plane shown by line CC Fig. 20A A cross-sectional view of the delivery catheter 114. Fig. 20B is a cross-sectional view of the delivery catheter 114 taken along the plane indicated by line BB. Fig.20D Shows along Fig. 20A 14 is a cross-sectional view of the delivery catheter 114 taken along the plane indicated by line DD in FIG. Fig.20E By along Fig. 20A The cross-sectional view of the delivery catheter 114 is taken along the plane shown by line EE. Fig.21A and 21B Schematic perspective views of the delivery catheter 114 in partially and fully actuated states, respectively, similar to Fig.15 and 16 of the view. Fig.22A is a partial view of the delivery catheter 114 . Figures 22B-22D The Fig.22A Cross-sectional view of the delivery catheter taken along the planes indicated by lines BB, CC and DD. Fig.23 2037, 2038, 2039 and ridges 2040, 2041, it should be understood that the delivery catheter 114 can be configured with any number of rings and / or ridges, or without any rings or ridges.

[0157] In the illustrated embodiment, the delivery catheter 114 has a distal region 117 that includes two flexible sections 115, 116. Fig. 20C , the first flexible section 115 extends between the first ring 2037 and the second ring 2038. The first pull wire 2035 is attached to the first ring 2037 at the connection point A, and the actuation of the first pull wire 2035 causes the first flexible section 115 to form Fig.11 and 12 The generally circular configuration shown in FIG. Fig. 20C and 20DAs well as 22A and 22B, an optional ridge 2040 is connected between the first ring 2037 and the second ring 2038. The ridge 2040 is made of a harder material than the flexible tube 2030 and is therefore configured to limit movement, such as compression, between the rings 2037 and 2038 when the first pull wire 2035 is actuated. The ridge 2040 can be made of, for example, stainless steel, plastic, or any other suitable material that is harder than the flexible tube. The flexible tube 2030 can be made of, for example, nitinol, steel, and / or plastic, or a material that allows the delivery catheter 114 to be moved into a flexed configuration (e.g., such as Fig.12 In some embodiments, the ratio of the Shore D hardness of the ridge 2040 to the Shore D hardness of the flexible tube 2030 is between about 3:1. In some embodiments, the ratio of the Shore D hardness of the ridge 2040 to the Shore D hardness of the flexible tube 2030 is between about 1.5:1 and about 5:1, such as between about 2:1 and about 4:1, such as between about 2.5:1 and about 3.5:1. In an optional embodiment, the ratio of the Shore D hardness of the ridge 2040 to the flexible tube 2030 is greater than 5:1 or less than 1.5:1.

[0158] In an exemplary embodiment, the ridge 2040 is arranged substantially opposite to the first pull wire 2035 such that the center of the ridge 2040 is circumferentially offset by about 180 degrees from the first pull wire 2035. The center of the ridge 2040 may be circumferentially offset by between about 70 degrees and about 110 degrees from the first pull wire 2035, such as between about 80 degrees and about 100 degrees, such as between about 85 degrees and about 95 degrees. Fig. 22B The width of the ridge 2040 (defined by the angle θ) may be such that the delivery catheter 114 is moved to Fig.11 and 12 2201, 2203. In some embodiments, the angle θ between the edges 2201, 2203 of the ridge 2040 can be between about 45 degrees and about 135 degrees, such as between about 60 degrees and about 120 degrees, such as between about 75 degrees and about 105 degrees, such as between about 85 degrees and 95 degrees, such as about 90 degrees. A larger angle θ allows the ridge 2040 to have more control over the movement of the restriction rings 2037, 2038 than a smaller angle θ. The ridge 2041 can be made of, for example, nitinol, steel, and / or plastic, or any other suitable material or combination of materials.

[0159] refer to Fig. 20B , the second flexible section 116 extends between the second ring 2038 and the third ring 2039. The second pull wire 2036 is attached to the second ring 2038 at the connection point B, and the actuation of the second pull wire 2036 causes the second flexible section 116 to form Fig.11 and 12 The sharper bend shown in . Fig. 20B and20E As well as 22A and 22C, an optional ridge 2041 is connected between the second ring 2038 and the third ring 2039. The ridge 2041 is made of a harder material than the flexible tube 2030 and is therefore configured to limit movement between the rings 2038, 2039 when the second pull wire 2036 is actuated. The ridge 2041 can be made of, for example, stainless steel, plastic, or any other suitable material that is harder than the flexible tube. The flexible tube 2030 can be made of, for example, nitinol, steel, and / or plastic, or a material that allows the delivery catheter 114 to be moved into a flexed configuration (e.g., such as Fig.12 In some embodiments, the ratio of the Shore D hardness of the ridge 2041 to the Shore D hardness of the flexible tube 2030 is between about 3:1. In some embodiments, the ratio of the Shore D hardness of the ridge 2041 to the Shore D hardness of the flexible tube 2030 is between about 1.5:1 and about 5:1, such as between about 2:1 and about 4:1, such as between about 2.5:1 and about 3.5:1. In an optional embodiment, the ratio of the Shore D hardness of the ridge 2041 to the flexible tube 2030 is greater than 5:1 or less than 1.5:1.

[0160] In an exemplary embodiment, the ridge 2041 is arranged substantially opposite to the second pull wire 2036 such that the center of the ridge 2041 is circumferentially offset from the second pull wire 2036 by about 180 degrees. The center of the ridge 2041 may be circumferentially offset from the second pull wire 2036 by between about 70 degrees and about 110 degrees, such as between about 80 degrees and about 100 degrees, such as between about 85 degrees and about 95 degrees. Fig. 22C The width of the ridge 2041 (defined by the angle β) may be such that the delivery catheter 114 is moved to Fig.12 In some embodiments, the angle β between the edges 2205, 2207 of the ridge 2041 can be between about 45 degrees and about 135 degrees, such as between about 60 degrees and about 120 degrees, such as between about 75 degrees and about 105 degrees, such as between about 85 degrees and 95 degrees, such as about 90 degrees. A larger angle β allows the ridge 2040 to have more control over the movement of the confinement rings 2037, 2038 (i.e., add greater stiffness) than a smaller angle β.

[0161] refer to Fig.20D and 20E The delivery catheter 114 includes a lumen 2032 that is sufficiently sized to deliver the anchoring device 1 therethrough, and the lumen 2032 is sufficiently sized to actuate the first pull wire 2035 and the second pull wire 2036 to move the delivery catheter 114 to the Fig.12The anchoring device 1 is delivered in the bent configuration shown. The lumen 2032 may have, for example, an oval cross-section, a circular cross-section, or may have a cross-section of any other suitable shape as long as the anchoring device 1 can be effectively advanced through the lumen 2032.

[0162] The connection point B for attaching the second pull wire 2036 to the second ring 2038 is positioned proximal to the connection point A for attaching the first pull wire 2035 to the first ring 2037 and can be offset in the circumferential direction, for example, by about 90 degrees around the distal region 117. The 90 degree offset allows for two orthogonal bends in the region, wherein the respective radii of curvature and articulation directions of the segments 115, 116 can be different and independent of each other. In some embodiments, the segments 115, 116 can be offset in the circumferential direction, for example, between about 65 degrees and about 115 degrees, such as between about 75 degrees and about 105 degrees, such as between about 80 degrees and about 100 degrees, such as between about 85 degrees and about 95 degrees. Reference Fig. 20C and 20E In certain embodiments, the wires 2035, 2036 extend along the length L of the delivery catheter 114 such that the wires are substantially parallel to an axis X extending through the center of the delivery catheter. In this embodiment, the wires 2035, 2036 are offset in the circumferential direction such that the angle α between the wires 2035, 2036 is between about 65 degrees and about 115 degrees, such as between about 75 degrees and about 105 degrees, such as between about 80 degrees and about 100 degrees, such as between about 85 degrees and about 95 degrees, such as about 90 degrees.

[0163] refer to Figures 9A-9U 20A-23, in practice, for example, once the introducer sheath 20 is positioned proximate to a native valve annulus (e.g., a mitral valve annulus or a tricuspid valve annulus) in the position shown, the distal region of the delivery catheter 114, including the distal region 117 (and in some embodiments, including a portion of the proximal segment 2034), is advanced out of the distal opening of the introducer sheath 20. At this point, the portion of the delivery catheter 114 extending out of the introducer sheath 20 may be positioned in an atrium (e.g., the left atrium or the right atrium), and in some cases, the portion of the delivery catheter 114 may also be slightly extended (e.g., 1-5 mm or less) through the native valve (e.g., the native mitral valve) or the commissures of the native valve into a ventricle (e.g., the left ventricle or the right ventricle) before the delivery catheter 114 is adjusted to its actuated configuration or, if previously partially actuated, adjusted to its full or final actuated configuration. The pull wires 2035, 2036 may then be tightened to actuate the distal region 117 and obtain articulation of the two bends in the segments 115, 116 at the distal portion of the delivery catheter 114. For example, in one sequence, as Fig.21AAs shown, the second pull wire 2036 can be first tightened to bend the segment 116 and place a portion of the delivery catheter 114 distal to the segment 116 substantially planar with the native valve annulus (e.g., the native mitral valve annulus). Fig. 21B As shown, the first pull wire 2035 can then be tightened to bend the segment 115 into its circular or curved actuated state so that the curvature of the segment 115 is substantially planar or parallel to the plane of the native valve ring (e.g., the mitral valve plane). In other embodiments, the pull wires 2035, 2036 can be partially or completely tightened in different amounts and / or sequences to appropriately and safely guide around the patient's anatomical structure or relative to the patient's anatomical structure during actuation. For example, the pull wires 2035, 2036 can be tightened to move the delivery catheter 114 in the same manner as the delivery catheter 64 in 9A-9U moves. The actuation of the pull wire or pull wire system can be used in combination with a torsion or rotation delivery device or a portion thereof (e.g., a delivery catheter or sheath) to point the distal region and distal tip of the catheter to a desired position and / or orientation.

[0164] For example, after the distal region 117 of the delivery catheter 114 is fully actuated or actuated to a desired configuration (eg, Fig. 21B ), the assembly can then be twisted and rotated so that the tip of the delivery catheter 114 is aligned with the commissures of the native valve (e.g., the commissures of the native mitral valve, such as at commissures A3P3). The delivery catheter 114 can be twisted and rotated so that the distal tip of the delivery catheter 114 is pointed toward and / or into the commissures. Further rotation of the delivery catheter 114 can then facilitate circumferential advancement of the distal tip of the delivery catheter 114 toward and / or into the commissures, and / or change direction from a downward direction to a more flat (even) or parallel (or less downward) direction (e.g., after the first end of the anchoring device is pushed out or squeezed out of the delivery catheter), so that the end of the anchoring device does not undesirably rise and hit or push against the underside of the annulus after insertion, so that the anchoring device 1 can be looped or positioned around the exterior of native anatomical structures such as chordae tendineae, papillary muscles and / or other features in the ventricle (e.g., exterior of the native mitral valve anatomy).

[0165] refer to Figures 22A-22D23, in certain embodiments, the delivery catheter 114 includes a first guide wire tube 2210 (e.g., a tube, a sleeve, etc.) for accommodating a first pull wire 2035, and a second guide wire tube 2212 for accommodating a second pull wire 2036. In an exemplary embodiment, the guide wire tubes 2210, 2212 are at least partially defined by a liner 2215 and an inner surface 2216 of the flexible tube 2030. In some embodiments, the guide wire tubes 2210, 2212 may take any other suitable form. In some embodiments, the guide wire tubes are not used to accommodate the pull wires 2035, 2036. When the pull wires 135, 136 are operated, the design of the proximal section 140 and the arrangement of the pull wires 2035, 2036 provide an anti-whipping or anti-bending effect through the delivery catheter 114. This can allow the delivery catheter 114 to maintain full torsionability through the transseptal bend. This can also facilitate more effective retention and maintenance of the actuated shape of the distal region 117 during torsion or rotation during delivery. In some embodiments, the delivery catheter 114 includes a first coil sleeve 2211 extending around the first pull wire 2035 until it reaches the first flexure section 115 and a second coil sleeve 2213 extending around the second pull wire 2036 until it reaches the second flexure section 116. The coil sleeves 2211, 2213 are configured to provide an anti-whiplash or anti-bending effect and to maintain full torsionability of the delivery catheter 114.

[0166] The deployment of the delivery device 1 from the delivery catheter 114 (and optionally, the movement of the delivery catheter 114 around the anatomical structures in the ventricle) serves to gather or capture the enclosed anatomical structures within the anchoring device 1. In some embodiments, the distal region 117 of the delivery catheter 114 is moved to a desired position around the chordae and other features in the left ventricle, and the first pull wire 135 is tightened to reduce the radius of curvature of the circular segment 115, and to tighten and gather the chordae and other mitral valve anatomical structures passing through the center of the circular segment 115, even further toward the center of the native annulus. This radial tightening or gathering of the mitral valve anatomical structures in the left ventricle can later help facilitate even more robust delivery of the anchoring device 1 - for example, by making it easier to advance the anchoring device 1 around the gathered chordae and other features.

[0167] When the delivery catheter is used in the ventricle to surround the native anatomical structure, the anchoring device 1 can be advanced to the outside of the distal opening of the delivery catheter 114 after the delivery catheter 114 has been satisfactorily positioned around the chordae tendineae and other desired anatomical structures in the left ventricle. The curved shape of the circular segment 115 can promote smoother and easier extrusion of the anchoring device 1 from the delivery catheter 114, because the curvature of the circular segment 115 can be formed to substantially approximate the final curvature of the anchoring device 1. In addition, the initial annulation of the distal region 117 around at least a portion of the desired mitral valve anatomical structure in the left ventricle promotes easier delivery of the anchoring device 1 to the outside and around the same anatomical structure that has been surrounded. Once the ventricular portion of the anchoring device 1 has been advanced to the desired position in the left ventricle, the atrial portion of the anchoring device 1 can be released from the delivery catheter 114 in a manner similar to one of the various ways discussed above - for example, by axially translating the delivery catheter 114 backward. This translation of the delivery catheter 114 can also help the delivery catheter 114 itself to be retracted out of the left ventricle and back into the left atrium. Then, after the anchoring device 1 has been fully delivered and moved to the desired position, the tension in the pull wires 2035, 2036 can be released, and the delivery catheter 114 can be straightened and retracted through the guide sheath 20. Thereafter, similar to the previous discussion, the THV or other prosthetic valve can be advanced to the anchoring device 1 and expanded in the anchoring device 1.

[0168] In some embodiments (e.g., any of the embodiments of the delivery catheters described in the present application), an atraumatic tip 118 may also be formed at the end of the distal region 117 to prevent or reduce potential damage to the guide sheath 20 or the patient's anatomical structure when the delivery catheter 114 is advanced and manipulated to its desired position and orientation. The atraumatic tip 118 may be an extension of the distal region 117 formed in a rounded or other atraumatic shape, or may be, for example, an added layer formed of a different material than the distal region 117, for example, an additional braided layer and / or made of a lower durometer material.

[0169] Optionally, the anchoring device or docking device may also include a low friction sleeve, such as a PTFE sleeve, which fits around all or part of the anchoring device or docking device (e.g., the leading turn and / or the functional turn). For example, the low friction sleeve may include a cavity in which the anchoring device (or a portion thereof) fits. The low friction sleeve can make it easier for the anchoring device to slide and / or rotate into position because it leaves the delivery catheter with less friction than the surface of the anchoring device and is less likely to cause wear or damage to the natural tissue. After the anchoring device is in the appropriate position in the natural valve, the low friction sleeve can be removable (e.g., by pulling proximally on the sleeve while keeping the pusher and the anchoring device in place), thereby, for example, exposing a portion that may be configured (porous, braided, large surface area, etc.) to promote tissue ingrowth or the surface of the anchoring device including the portion.

[0170] The delivery catheter structure described herein provides an exemplary embodiment that allows accurate positioning and deployment of the anchoring device. However, in some cases, it is still necessary to retrieve or partially retrieve the anchoring device at any stage during or after the deployment of the anchoring device, so as to reposition the anchoring device at the natural valve, or remove the anchoring device from the implantation site. The following embodiments describe various locks or lock release mechanisms that can be used to attach and / or detach the anchoring device or docking device from the deployment pusher that pushes the anchoring device out of the delivery catheter. Other locks or locking mechanisms are also possible, for example, as described in U.S. Provisional Patent Application Serial No. 62 / 560,962 filed on September 20, 2017, which is incorporated herein by reference. The anchoring device can be connected to a pusher at its proximal side or can be pushed, pulled and easily separated from the anchoring device.

[0171] In the previous examples, a suture or thread of a pusher or pusher tool is passed through an opening or eyelet in the end of the anchor device to retain the anchor device and allow the anchor device to be retracted and released. Figures 17A-17C A perspective view of the proximal end 82 of an exemplary anchoring device 81 and a ball locker or locking mechanism 84 is shown. Fig.17A As shown in FIG. 1 , the anchoring device 81 may be similar to the above-described anchoring device embodiments, with the addition of a modified proximal end 82. The proximal end 82 of the anchoring device 81 has an elongated tubular structure 83 forming a locking tube, and a ball locking mechanism 84 includes a pusher 85 (which may be the same or similar to other pushers herein with modifications) and a pull wire 86 that interacts with the locking tube 83. The pusher 85 includes a flexible tube 87, although the flexible tube 87 is Figures 17A-17C81, but can be long enough to extend through the delivery catheter during the deployment of the anchoring device 81. The pull wire 86 extends through the pusher 85 and can allow the pull wire 86 to also protrude through the length of the locking tube 83 of the anchoring device 81 through the distal end of the pusher 85. The pusher 85 has a distal tip 88 and a short wire 89 connected to and / or extending from the pusher tip 88. The distal end of the short wire 89 includes a spherical ball 90.

[0172] like Fig. 17B As shown in the figure, the locking tube 83 at the proximal end 82 of the anchoring device 81 is sized to receive the spherical ball 90 of the short wire 89 passing therethrough. The locking tube 83 is a short tube that can be welded or otherwise attached to the proximal end (oriented during delivery) of the anchoring device 81. The inner diameter of the locking tube 83 is slightly larger than the outer diameter of the spherical ball 90 so that the ball 90 can pass through it. The lock or locking mechanism is based on the relative diameter of the inner diameter of the locking tube 83, the diameter of the ball 90, and the diameter of the other parts of the short wire 89 and the diameter of the pull wire 86.

[0173] After the ball 90 passes through and leaves the distal end of the locking tube 83, locking can be achieved by preventing the ball 90 from passing back through the locking tube 83 and being released from the locking tube 83. This can also be achieved by inserting a pull wire 86 into the locking tube 83. Figures 17C-17D As shown in FIG. 1 , when the thinner portions of both the short wire 89 and the pull wire 86 are threaded into and positioned in the locking tube 83, the ball 90 is prevented from passing back through the locking tube 83 and thereby locking the anchoring device 81 to the pusher 85. Fig.17D As best shown, when the pull wire 86 is in the locking tube 83, the pull wire 86 prevents the short wire 89 from moving to a more central position in the bore of the locking tube 83, preventing the ball 90 from aligning with and retracting out through the locking tube 83. Thus, when the pusher 85 is pulled proximally from the distal end of the locking tube 83, the ball 90 abuts against the distal end of the locking tube 83. In this locked position, the pusher 85 is locked to the anchor 81, and the pusher 85 can push or pull the anchor 81 to more accurately position the anchor 81 during surgery. Only when the pull wire 86 is pulled back out of the locking tube 83 is there a clear path and sufficient space for the ball 90 to align with and release from the locking tube 83 and for the anchor 81 to be unlocked or disconnected from the pusher 85. At the same time, retracting the pull wire 86 to unlock the anchoring device 81 requires only a relatively small pulling force, because the locking force relies mainly on the short wire 89, which bears most of the load when the mechanism is locked.

[0174] The pull wire 86 also only needs to travel a short distance to be removed from the locking tube 83. For example, unlocking the anchoring device 81 from the pusher 85 may only involve retracting the pull wire 86 by about 10 mm to remove the pull wire 86 from the locking tube 83 and allow the spherical ball 90 to release. In other embodiments, the anchoring device 81 may be unlocked from the pusher 85 by retracting the pull wire 86 between about 6 mm and about 14 mm, such as between about 7 mm and about 13 mm, such as between about 8 mm and about 12 mm, such as between about 9 mm and about 11 mm. In certain embodiments, the anchoring device 81 may be unlocked from the pusher 85 by retracting the pull wire 86 less than 6 mm or more than 14 mm. Figures 17A-17D Embodiments of the present invention provide a secure and reliable locking mechanism that can achieve a strong locking force, while at the same time requiring only a small pulling force to unlock and disengage the components from each other.

[0175] When used, prior to implantation, e.g. Fig. 17C As shown in FIG, the ball locking mechanism 84 can be assembled with the anchoring device 81. After positioning the distal section of the delivery catheter at or near the native valve annulus (e.g., at the mitral valve annulus), the ball locking mechanism 84 can be assembled with the anchoring device 81. Figure 8 , 9A -9U and 10 described in one of the techniques, the pusher 85 can push the anchoring device 81 through the delivery catheter to deploy the anchoring device 81. The user can then use the pusher 85 to further retract and / or advance the anchoring device 81 at the native valve annulus to more accurately position the anchoring device 81 at the implantation site. Fig. 17B As shown in FIG. 8 , once the anchoring device 81 is properly positioned, the pull wire 86 can be retracted from the locking tube 83 and the anchoring device 81 can be properly positioned. Fig.17A As shown, the spherical ball 90 may then also be retracted and released from the locking tube 83, thereby disengaging the anchoring device 81 from the ball locking mechanism 84. The pusher 85 may then be removed from the implantation site.

[0176] Figures 18A-18C A perspective view of the proximal end 92 and the ring locking mechanism 94 of the anchoring device 91 is shown according to an embodiment of the present invention. Fig.18AAs shown in , the anchoring device 91 can be similar to the above-mentioned anchoring device embodiment, wherein a modified proximal end 92 is added. The proximal end 92 of the anchoring device 91 has an elongated proximal hole or slot 93, and the ring locking mechanism 94 includes a pusher 95 and a side wire or pull wire 96 that interacts with the hole 93. The pusher 95 includes a flexible tube 97, which can be long enough to extend through the delivery catheter during the deployment of the anchoring device 91. As discussed in more detail below, the pull wire 96 extends through the pusher 95 and can allow the pull wire 96 to engage the length of the wire loop 99 protruding through the distal end of the pusher 95. The pusher 95 has a distal tip 98 and a wire loop 99 connected to the pusher tip 98 and / or extending from the pusher tip 98. In this embodiment, the loop 99 extends distally from the distal tip 98 of the pusher 95 and has a distal-most loop portion extending generally perpendicular to the longitudinal axis of the pusher 95. Although the wire loop 99 is shown as a wire, such as a cylindrical wire, in this embodiment, the present invention is not limited thereto. In other embodiments, the loop 99 may also be made of, for example, a flat piece of metal or other material, which is laser cut, may be formed by using sutures, or may be in any other suitable form that can enter the slot 93 of the anchoring device 91 and receive the pulling wire 96 to fix the anchoring device 91 to the pusher 95.

[0177] like Fig.18B As shown in FIG, the hole 93 at the proximal end 92 of the anchoring device 91 is sized to receive the end of the wire loop 99. When the wire loop 99 is inserted into the hole 93 and passes through the hole 93, the end of the wire loop 99 extends out of the opposite side of the hole 93, so that the loop 99 is exposed or protrudes from the opposite side. Fig.18C As shown in FIG. 1 , the ring 99 should be able to protrude from the opposite side of the hole 93 by an amount sufficient to allow the pull wire 96 to be inserted into the ring 99 or threaded through the ring 99. Then, as shown in FIG. Fig.18C As shown in , by passing the pull wire 96 through the loop 99, the anchor device 91 can be attached to or engage the pusher 95 in a locked position, wherein the pusher 95 can push or pull the anchor device 91 to more accurately position the anchor device 91 during surgery. In this locked position, the pull wire 96 anchors the loop 99 in place and prevents the loop 99 from retracting out of the hole 93. Only when the pull wire 96 is pulled back out of the loop 99 can the loop 99 be disengaged from the hole 93 and the anchor device 91 can be unlocked or disconnected from the pusher 95. At the same time, retracting the pull wire 96 to unlock the anchor device 91 requires only a relatively small pulling force, because the locking force relies mainly on the loop 99, which bears most of the load when the mechanism is locked.

[0178] The ring locking mechanism 94 relies on the interaction between the ring 99 of the pusher 95 and the pull wire 96. Therefore, the length of the ring 99 should be long or high enough to protrude from the side of the hole 93 opposite to the insertion side to leave enough space for the pull wire 96 to pass through, and short enough to reduce vertical displacement when locked to maintain a tight connection between the pusher 95 and the anchoring device 91. Therefore, Figures 18A-18C The embodiments of the present invention also provide a secure and reliable locking mechanism that can achieve a strong locking force while also requiring only a small pulling force and a small amount of retraction of the pull wire 96 to unlock the assembly. For example, unlocking the anchoring device 91 from the pusher 95 may involve only retracting the pull wire 96 by about 10 mm to remove the pull wire 96 from the loop 99 and allow the loop 99 to release. In other embodiments, the anchoring device 91 can be unlocked from the pusher 95 by retracting the pull wire 96 between about 6 mm and about 14 mm, such as between about 7 mm and about 13 mm, such as between about 8 mm and about 12 mm, such as between about 9 mm and about 11 mm. In certain embodiments, the anchoring device 91 can be unlocked from the pusher 95 by retracting the pull wire 86 less than 6 mm or more than 14 mm.

[0179] When used, before surgery, such as Fig.18C As shown in FIG. , the ring locking mechanism 94 can be assembled with the anchoring device 91. Figure 8 , 9A -9U and 10 described in one of the techniques, after positioning the distal section of the delivery catheter at or near the native valve annulus (e.g., at the mitral valve annulus), the pusher 95 can push the anchoring device 91 through the delivery catheter to deploy the anchoring device 91. The user can then use the pusher 95 to further retract and / or advance the anchoring device 91 at the native valve annulus to more accurately position the anchoring device 91 at the implantation site. Fig.18B As shown in FIG. 1 , once the anchoring device 91 is precisely positioned, the pull wire 96 can be retracted away from the loop 99 and the anchoring device 91 can be precisely positioned. Fig.18A As shown, the ring 99 can then be retracted away from the hole 93, thereby disengaging the anchoring device 91 from the ring locking mechanism 94. The pusher 95 can then be removed from the implantation site.

[0180] Additional pushers and retrieval devices and other systems, devices, assemblies, methods, etc. are disclosed in U.S. Provisional Patent Application Serial No. 62 / 436,695 filed on December 20, 2016 and U.S. Provisional Patent Application Serial No. 62 / 560,962 filed on September 20, 2017 and related PCT Patent Application entitled "SYSTEMS AND MECHANISMS FOR DEPLOYINGA DOCKING DEVICE FOR A REPLACEMENT HEART VALVE" filed on December 15, 2017 (claiming priority to the aforementioned provisional applications), each of which is incorporated herein by reference in its entirety. Any embodiments and methods disclosed in the aforementioned applications can be used together with any embodiments and methods disclosed in the present application, mutatis mutandis.

[0181] The various manipulations and controls of the systems and devices described herein can be automated and / or mechanized. For example, the above-mentioned control member or knob can be a button or electrical input that causes the action described about the control member / knob above. This can be accomplished by connecting some or all moving parts (directly or indirectly) to a motor (e.g., electric motor, pneumatic motor, hydraulic motor, etc.) actuated by a button or electrical input. For example, a motor can be configured to, when actuated, tighten or relax a control wire or a pull wire as described herein to move the distal region of a catheter. Additionally or alternatively, a motor can be configured to, when actuated, move a pusher translationally or axially relative to the catheter so that an anchoring device or a docking device moves in the catheter and / or moves into or out of the catheter. Automatic stop or precautions can be established to prevent damage to the system / device and / or the patient, for example, to prevent the assembly from moving beyond a certain point.

[0182] It should be noted that the devices and apparatus described herein can be used with other surgical procedures and access points (e.g., transapical, open heart, etc.) It should also be noted that the devices described herein (e.g., deployment tools) can also be used in combination with various other types of anchoring devices and / or prosthetic valves than the examples described herein.

[0183] For the purpose of this specification, some aspects, advantages and novel features of the embodiments of the present disclosure are described herein. The disclosed methods, devices and systems should not be interpreted as being limited in any way. On the contrary, the present disclosure relates to all novel and non-obvious features and aspects of various disclosed embodiments (individually and in various combinations and sub-combinations with each other). The methods, devices and systems are not limited to any specific aspect or feature or combination thereof, and the disclosed embodiments do not require that any one or more specific advantages should exist or problems should be solved. The features, elements or components of an embodiment can be combined in other embodiments of this article.

[0184] For the convenience of presentation, although the operations of some disclosed embodiments are described in a specific order, it should be understood that unless a specific language requires a specific ordering, this description includes rearrangement. For example, the operations described in order can be rearranged or performed simultaneously in some cases. In addition, for the sake of brevity, the accompanying drawings may not show the various ways in which the methods disclosed therein can be used in combination with other methods. Additionally, the description sometimes uses terms such as "providing" or "implementing" to describe the disclosed methods. These terms are high-level abstractions of the actual operations performed. The actual operations corresponding to these terms can vary based on the specific implementation and can be easily discerned by a person of ordinary skill in the art. The steps of the various methods herein can be combined.

[0185] In view of the many possible embodiments to which the principles of the present disclosure may be applied, it should be recognized that the illustrated embodiments are only preferred examples of the present invention and should not be taken as limiting the scope of the present disclosure. Rather, the scope of the present disclosure is defined by the appended claims.

Claims

1. A delivery catheter for delivering a device to a native valve of a patient's heart, comprising: a flexible tube having a main lumen and a control wire lumen, wherein a distal region of the flexible tube includes a plurality of joints, and the flexible tube further includes a proximal portion having a first end, a distal portion having a second end, and a bore extending between the first end and the second end, the bore being sized for passage of an anchor device therethrough; Each link is aligned with and connected to an adjacent link and has top teeth and side teeth and corresponding slots, and the slots of each link have a shape complementary to the side teeth or top teeth of the adjacent link; and wherein each link has a greater width at the bottom than at the top, so that when the link is viewed from the side, each link has the shape of an acute trapezoid; as well as a control wire in a control wire catheter, the control wire being connected to the distal region of the flexible tube; wherein applying tension to the control wire causes the distal region of the flexible tube to bend; and The bottom of each link includes at least one slot to allow the links to flex more relative to each other. 2 . The delivery catheter of claim 1 , wherein each coupling section is connected to the adjacent coupling section at a bottom of the coupling section.

3. The delivery catheter of claim 1, wherein when tension is applied to the control wire to bend the distal region, the top of the joint moves a greater distance.

4. The delivery catheter of claim 1, wherein the plurality of links are in a straight configuration when tension is removed from the control wire.

5. The delivery catheter of claim 1, wherein a distal section of the delivery catheter is coated with PEBAX.

6. The delivery catheter of claim 5, wherein a distal section of the delivery catheter is composed of at least one of nitinol, stainless steel, or plastic.

7. A delivery catheter according to claim 1, wherein the control wire includes a first control wire and a second control wire, and the delivery catheter includes a first ring located in a distal region of the flexible tube and a second ring located in the distal region of the flexible tube, the second ring being spaced apart from the first ring, wherein the first control wire is movably coupled to the first ring at a first actuation point, and the second control wire is movably coupled to the second ring at a second actuation point.

8. The delivery catheter of claim 1, wherein the coupling is cut from a single tube.

9. The delivery catheter of claim 1, wherein the coupling section is cut from a single flat sheet that is rolled to form the coupling section.

10. The delivery catheter of claim 1, wherein the control wire extends distally through the slot and is attached to the distal region by a loop.

11. The delivery catheter of claim 7, further comprising: Wherein the plurality of joints are arranged in the distal region of the flexible tube between the first ring and the second ring.

12. The delivery catheter of claim 7, further comprising a coil sleeve disposed in the control wire lumen around the control wire.

13. The delivery catheter of claim 12, wherein the coil sleeve extends proximally from the distal region of the flexible tube such that a portion of the control wire extending from the second ring to the first ring is not covered by the coil sleeve.

14. A delivery catheter for delivering a device to a native valve of a patient's heart, comprising: a flexible tube having a main lumen and a control wire lumen, wherein a distal region of the flexible tube includes a plurality of joints, and the flexible tube further includes a proximal portion having a first end, a distal portion having a second end, and a bore extending between the first end and the second end, the bore being sized for passage of an anchor device therethrough; a first ring located in the distal region of the flexible tube; a second ring located in the distal region of the flexible tube, the second ring being spaced apart from the first ring, wherein the plurality of joints are located between the first ring and the second ring; a control wire in a control wire conduit, the control wire being connected to the first ring; and a coil sleeve, the coil sleeve being arranged in the control wire cavity and surrounding the control wire; wherein the coil sleeve extends proximally from the distal region of the flexible tube such that a portion of the control wire extending from the second loop to the first loop is not covered by the coil sleeve; wherein applying tension to the control wire causes the distal region of the flexible tube to bend; and The bottom of each link includes at least one slot to allow the links to flex more relative to each other.

15. The delivery catheter of claim 14, wherein each coupling section is connected to an adjacent coupling section at a base of the coupling section.

16. The delivery catheter of claim 14, each link having a greater width at a base than at a top such that each link has the shape of an acute trapezoid when the link is viewed from the side.

17. The delivery catheter of claim 16, wherein when tension is applied to the control wire to bend the distal region, the top of the joint moves a greater distance.

18. The delivery catheter of claim 14, wherein the plurality of links are in a straight configuration when tension is removed from the control wire.

19. The delivery catheter of claim 14, wherein a distal section of the delivery catheter is coated with PEBAX.

20. The delivery catheter of claim 19, wherein the distal section of the delivery catheter is composed of at least one of nitinol, stainless steel, or plastic.

21. A delivery catheter according to claim 14, wherein the control wire includes a first control wire and a second control wire, and wherein the first control wire is movably coupled to the first ring at a first actuation point, and the second control wire is movably coupled to the second ring at a second actuation point.

22. A delivery catheter according to claim 14, wherein the plurality of couplings are cut from a single tube so that each coupling is aligned with and connected to an adjacent coupling and has top and side teeth and corresponding slots, and the slots of each coupling have a shape complementary to the side teeth or top teeth of the adjacent coupling.

23. A delivery catheter according to claim 14, wherein the plurality of coupling sections are cut and rolled from a single flat sheet so that each coupling section is aligned with and connected to an adjacent coupling section and has top teeth and side teeth and corresponding slots, and the slots of each coupling section have a shape complementary to the side teeth or top teeth of the adjacent coupling section.

24. The delivery catheter of claim 22, wherein the control wire is configured to extend distally through the slot and is configured to be attached to the distal section at least at one connection point in the distal section by welding.

25. A delivery catheter for delivering a device to a native valve of a patient's heart, comprising: a flexible tube having a central main lumen and a control wire lumen, wherein a distal region of the flexible tube includes a plurality of joints, and the flexible tube further includes a proximal portion having a first end, a distal portion having a second end, and a bore extending between the first end and the second end, the bore being sized for passage of an anchor device therethrough; a first ring located in the distal region of the flexible tube; a second ring located at the distal region of the flexible tube, the second ring being spaced apart from the first ring, wherein the plurality of joints are located between the first ring and the second ring; a control wire in a control wire conduit, the control wire being connected to the first ring; wherein the plurality of cylindrical coupling sections are cut from a single sheet of material, so that each coupling section is aligned with and connected to an adjacent coupling section and has top teeth and side teeth and corresponding slots, and the slots of each coupling section have a shape complementary to the side teeth or top teeth of the adjacent coupling section; and a coil sleeve, the coil sleeve being arranged in the control wire cavity and surrounding the control wire; wherein the coil sleeve extends proximally from the distal region of the flexible tube such that a portion of the control wire extending from the second loop to the first loop is not covered by the coil sleeve; wherein applying tension to the control wire causes the distal region of the flexible tube to bend; and The bottom of each link includes at least one slot to allow the links to flex more relative to each other.

26. The delivery catheter of claim 25, wherein each coupling section is connected to the adjacent coupling section at a base of the coupling section.

27. The delivery catheter of claim 25, wherein each link has a greater width at the bottom than at the top, such that each link has the shape of an acute trapezoid when the link is viewed from the side.

28. The delivery catheter of claim 27, wherein when tension is applied to the control wire to bend the distal region, the top of the joint moves a greater distance.

29. The delivery catheter of claim 25, wherein the plurality of links are in a straight configuration when tension is removed from the control wire.

30. The delivery catheter of claim 25, wherein a distal section of the delivery catheter is coated with PEBAX.

31. The delivery catheter of claim 30, wherein the distal section of the delivery catheter is composed of at least one of nitinol, stainless steel, or plastic.

32. A delivery catheter according to claim 25, wherein the control wire includes a first control wire and a second control wire, and wherein the first control wire is movably coupled to the first ring at a first actuation point, and the second control wire is movably coupled to the second ring at a second actuation point.

33. The delivery catheter of claim 25, wherein the coupling is cut from a single tube.

34. The delivery catheter of claim 25, wherein the coupling section is cut from a single flat sheet that is rolled to form the coupling section.

35. The delivery catheter of claim 30, wherein the control wire is configured to extend distally through the slot and is configured to be attached to the distal section at least at one connection point in the distal section by welding.

36. The delivery catheter of claim 25, wherein the control wire is attachable to an anchor ring positioned at or distal to the first end.

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