HK40058059B - Deployment systems, tools, and methods for delivering an anchoring device for a prosthetic valve - Google Patents

Description

Deployment systems, tools, and methods for delivering prosthetic valve anchoring devices.

Related applications

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

Technical Field

This disclosure generally relates to deployment tools and methods of using them for delivering anchoring devices, such as prostheses docking devices. For example, this disclosure relates to the replacement of a heart valve with deformity and/or dysfunction, wherein an anchoring device supporting the prosthetic heart valve is deployed at the implantation site using a flexible delivery catheter, and a method of implanting such an anchoring device and/or the prosthetic heart valve using the delivery catheter.

Background Technology

Referring generally to Figures 1A-1B, the natural mitral valve 50 controls blood flow from the left atrium 51 to the left ventricle 52 of the human heart, and similarly, the tricuspid valve 59 controls blood flow 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 consists of a valve annulus formed by natural valve tissue surrounding the mitral orifice, and a pair of cusps or leaflets extending downwards from the annulus into the left ventricle. The mitral valve annulus can form a "D," 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, forming an overall "C"-shaped boundary between the adjacent free edges of the leaflets when they are closed together.

When functioning normally, the anterior leaflet 54 and posterior leaflet 53 of the mitral valve work 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 relaxes (also known as ventricular diastole or relaxation), 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 contraction or contraction) to move the oxygenated blood out of the left ventricle 52 and through the aortic valve 63 and the aorta 58 to the rest of the body. During ventricular contraction, the increased blood pressure in the left ventricle causes the two leaflets of the mitral valve to come together, thus closing the one-way mitral valve and preventing blood from flowing back into the left atrium. To prevent or inhibit the two leaflets from prolapsing under pressure and folding back towards the left atrium through the mitral valve annulus during ventricular systole, multiple fibrous cords 62, called chordae tendineae, tether the leaflets to the papillary muscles in the left ventricle. The chordae tendineae 62 are schematically illustrated in the cross-section of the heart in Figure 1A and the top view of the mitral valve in Figure 1B.

A problem 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 valvular leakage, also known as regurgitation, which can occur in various heart valves, including the mitral and tricuspid valves. Mitral regurgitation occurs when the natural mitral valve fails to close properly, and blood flows from the left ventricle back into the left atrium during ventricular systole. Mitral regurgitation can have various causes, such as leaflet prolapse, papillary muscle dysfunction, problems with the chordae tendineae, and/or stretching of the mitral annulus due to left ventricular dilation. In addition to mitral regurgitation, mitral stenosis or narrowing is another instance 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.

Like the mitral and tricuspid valves, the aortic valve is also susceptible to complications such as aortic stenosis or aortic insufficiency. One approach to treating aortic heart disease involves the use of a prosthetic valve implanted within 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 coiled state on the distal portion of a flexible and/or steerable catheter, advanced to the implantation site in the heart via a vessel connected to the heart, and then expanded to its functional size, for example, by inflating a balloon onto which the THV is mounted. Alternatively, a self-expanding THV can be held radially compressed within a sheath of the delivery catheter, where the THV can be deployed from the sheath, which allows the THV to expand to its functional state. This delivery catheter and implantation technique is generally more advanced for implantation or use in the aortic valve but does not address the unique anatomy and challenges of other valves.

Summary of the Invention

This invention is intended to provide examples and is not intended to limit the scope of the invention in any way. For example, unless a feature is expressly defined in the claims, the claims do not claim any feature included in the examples of this invention. Moreover, the described features can be combined in various ways. Various features and steps described in other parts of this disclosure may be included in the examples outlined herein.

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 locations) to mitral and tricuspid valve positions. One way to adapt these other prosthetic valves to the mitral or tricuspid valve position is to deploy the prosthetic valve into an anchor or other docking station at the implantation site that will form a more appropriate shape at the natural valve annulus. The anchors or other docking stations described herein allow for more secure implantation of the prosthetic valve while also reducing or eliminating post-implantation perivalvular leakage.

One type of anchor or anchoring device that can be used herein is a coiled or spiral anchor that provides a circular or cylindrical mating portion for a cylindrical prosthetic valve. An anchor or anchoring device that can be used herein includes a coiled region and/or a spiral region that provides a circular or cylindrical mating portion for a cylindrical prosthetic valve. In this way, optionally, existing valve implants (possibly with some modifications) developed for the aortic location can be implanted together with such an anchor or anchoring device into other valve locations, such as the mitral valve location. Such an anchor or anchoring device can also be used for other natural heart valves (such as the tricuspid valve) to more securely anchor the prosthetic valve to those sites.

This document describes implementations of a deployment tool for assisting delivery of a prosthetic device at one of the natural mitral, aortic, tricuspid, or pulmonary valve regions of the human heart, and methods of using the deployment tool. The disclosed deployment tool can be used to deploy an anchoring device (e.g., a prosthesis docking device, a prosthesis valve docking device, etc.) at the implantation site—such as a helical anchoring device or anchoring device having multiple turns or coils—to provide a basic support structure in which a prosthetic heart valve can be implanted. The delivery tool may include a distal curved segment to guide its positioning during implantation of the anchor or anchoring device.

In one embodiment, a delivery catheter for delivering an anchoring device to the natural annulus of a patient's heart—where the anchoring device is configured to secure 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 includes a proximal portion having a first end, a distal portion having a second end, and an aperture extending between the first and second ends. The aperture is sized to allow the anchoring device to pass through. The distal portion includes a first flexing section and a second flexing section. The delivery catheter can be configured such that actuation of the first and second pull wires 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 may form a first curved portion, and the second flexing section may form generally circular and generally planar portions.

The delivery catheter may have a first ring and a second ring. The first ring may be positioned at a first actuation point, and a first traction wire may be attached to the first ring. The second ring may be positioned at a second actuation point, and a second traction wire may be attached to the second ring. The first traction wire may be offset from the second traction wire in the circumferential direction by approximately 65 degrees and approximately 115 degrees, such as approximately 90 degrees.

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 and second rings. A second spine may be disposed between the second and third rings. The first spine may be configured to restrict compressive movement between the first and second rings when the flexible tube is moved to a second configuration. The second spine may be configured to restrict bending between the second and third rings caused by the first pull filament 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.

The flexible end portion can be configured to be angled relative to the main portion of the circular or curved planar portion. For example, the vertical displacement between the flexible end portion and the main portion can be between approximately 2 mm and approximately 10 mm.

The catheter may also include a first coiled sleeve extending around at least a portion of a first pulling wire and/or a second coiled sleeve extending around at least a portion of a second pulling wire.

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

In another embodiment, a method of delivering an anchoring device to the natural annulus of a patient's heart using a delivery catheter—where the anchoring device is configured to secure a prosthesis to the natural 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 natural annulus such that the distal opening of the delivery catheter is positioned near the commissure of the natural valve, and adjusting at least one of the extension height or angle of the delivery catheter such that at least a portion of the delivery catheter is substantially parallel to the plane containing the natural annulus. When the natural valve is a mitral valve, the delivery catheter is advanced from the right atrium to the left atrium via the interatrial septum.

The systems and conduits outlined herein may also include any of the features, components, elements, etc., described in other parts of this disclosure, and the methods outlined herein may also include any steps described in other parts of this disclosure.

Attached Figure Description

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

Figure 1A shows a schematic cross-sectional view of the human heart;

Figure 1B shows a schematic top view of the mitral valve annulus of the heart;

Figure 2A shows a perspective view of an exemplary spiral-shaped anchoring device;

Figure 2B shows a partial perspective view of an exemplary delivery device for implanting an anchoring device into a natural valve of the heart using a transseptal technique.

Figure 2C shows a cross-sectional view of an anchoring device implanted in a natural heart valve and an exemplary prosthetic heart valve;

Figure 3A shows a perspective view of an exemplary distal segment of a delivery catheter used as part of an exemplary delivery device for implantation of an anchoring device;

Figure 3B is a cross-sectional view of several links in the distal segment of Figure 3A.

Figure 4 is a perspective view of the distal segment of a delivery catheter in a bent or curved configuration;

Figure 5 is a plan view of an exemplary laser cutsheet that can be used to form the distal segment of a delivery catheter;

Figure 6 is a plan view of another exemplary laser-cut sheet that can be used to form the distal segment of a delivery catheter;

Figure 7 is a plan view of another exemplary laser-cut sheet that can be used to form the distal segment of a delivery catheter;

Figure 8 shows a three-dimensional view of the curved or wavy configuration of the distal segment of a delivery catheter, for example, which can be used to implant an anchoring device into a natural valve using a transseptal technique.

Figure 9A is a side cutout view of a portion of a patient's heart, illustrating an exemplary delivery device that enters the left atrium through the fossa ovalis in an exemplary method;

Figure 9B illustrates the delivery device of Figure 9A entering the left atrium of a patient's heart in the position shown in Figure 9A, wherein the view taken along line B-B in Figure 9A shows the delivery device.

Figure 9C illustrates the delivery device of Figure 9A in the second position;

Figure 9D illustrates the delivery device of Figure 9A in the second position shown in Figure 9C, wherein the view taken along line D-D in Figure 9C shows the delivery device;

Figure 9E illustrates the delivery device of Figure 9A in the third position;

Figure 9F illustrates the delivery device of Figure 9A in the third position shown in Figure 9E, wherein the view taken along line F-F in Figure 9E shows the delivery device;

Figure 9G illustrates the delivery device of Figure 9A in the fourth position;

Figure 9H illustrates the delivery device of Figure 9A in the fourth position shown in Figure 9G, wherein the view taken along line H-H in Figure 9G shows the delivery device;

Figure 9I is a side sectional view of the left side of the patient's heart, illustrating the anchoring device delivered around the chordae tendineae and leaflets in the left ventricle of the patient's heart.

Figure 9J illustrates the anchoring device of Figure 9I, which, when delivered by the delivery device of Figure 9A, further wraps around the chordae tendineae and lobules in the left ventricle of the patient's heart;

Figure 9K illustrates the anchoring device of Figure 9I, which, when delivered by the delivery device of Figure 9A, further wraps around the chordae tendineae and leaflets in the left ventricle of the patient's heart;

Figure 9L is a top view of the patient's left atrium, illustrating the delivery device of Figure 9A after the anchoring device of Figure 9I wraps around the chordae tendineae and lobules in the left ventricle of the patient's heart.

Figure 9M illustrates the delivery device of Figure 9A in the left atrium of a patient's heart, wherein the delivery device is retracted to deliver a portion of the anchoring device into the left atrium of the patient's heart;

Figure 9N illustrates the delivery device of Figure 9A in the left atrium of a patient's heart, wherein the delivery device is retracted to deliver a further portion of the anchoring device into the left atrium of the patient's heart.

Figure 90 illustrates the delivery device of Figure 9A in the left atrium of a patient's heart, where the anchoring device is exposed and shown to be tightly connected to the pusher in the left atrium of the patient's heart;

Figure 9P illustrates the delivery device of Figure 9A in the left atrium of a patient's heart, wherein the anchoring device is completely removed from the delivery device and loosely and removably attached to the pusher via sutures;

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 patient's mitral valve via an exemplary embodiment of a heart valve delivery device.

Figure 9R illustrates the heart valve of Figure 9Q being further delivered to the patient's mitral valve via a heart valve delivery device;

Figure 9S illustrates the heart valve of Figure 9Q, which is opened by balloon inflation to dilate the heart valve and attach it to the patient's mitral valve;

Figure 9T illustrates the heart valve of Figure 9Q attached to the patient's mitral valve and secured by the anchoring device of Figure 9I.

Figure 9U is an upward view of the mitral valve from the left ventricle, illustrating the prosthetic heart valve of Figure 9Q attached to the patient's heart in a view taken along line U-U in Figure 9T.

Figure 10 shows a perspective view of a helical configuration of the distal segment of a delivery catheter that can be used to implant an anchoring device into a natural valve, which may optionally be used in transseptal techniques.

Figure 11 shows a perspective view of a hybrid configuration of the distal segment of a delivery catheter that can be used to implant an anchoring device into a natural valve, which can optionally be used in transseptal techniques;

Figure 12 shows a partial perspective view of an exemplary delivery device, for example, that can be used to implant an anchoring device into a natural mitral valve using another transseptal technique;

Figure 13 shows a schematic side view of an exemplary distal segment of a delivery catheter with an exemplary dual control filament or traction filament system that can be used in various delivery catheters or delivery devices described herein.

Figure 14 shows a cross-sectional view of the multi-lumen extruded portion of the delivery catheter of Figure 13, which is cut in a plane perpendicular to the longitudinal axis of the delivery catheter;

Figure 15 shows a schematic perspective view of the delivery catheter of Figures 13-14 in a partially actuated state;

Figure 16 shows a schematic perspective view of the delivery catheter of Figures 13-15 in a fully actuated state;

Figures 17A-17C show perspective views of exemplary lock or locking mechanisms for anchoring devices;

Figure 17D is a cross-sectional view of the lock or locking mechanism of Figures 17A-17C;

Figures 18A-18C show perspective views of another exemplary lock or locking mechanism for an anchoring device according to one embodiment; and

Figure 19 shows a perspective view of an exemplary distal segment of a delivery catheter that can be used as a part of a delivery device for implanting an anchoring device;

Figure 20A is an end view of another exemplary embodiment of the delivery catheter;

Figure 20B is a cross-sectional view taken along the plane shown by line B-B in Figure 20A;

Figure 20C is a cross-sectional view taken along the plane shown by line C-C in Figure 20C;

Figure 20D is a cross-sectional view taken along the plane shown by line D-D in Figure 20C;

Figure 20E is a cross-sectional view taken along the plane shown by line E-E in Figure 20C;

Figure 21A shows a schematic perspective view of the distal segment of the delivery catheter of Figures 20A-20E in a partially actuated state;

Figure 21B shows a schematic perspective view of the distal segment of the delivery catheter of Figures 20A-20E in a more actuated state;

Figure 22A is a partial view of the delivery catheters in Figures 20A-20E;

Figures 22B-22C show cross-sectional views of the delivery catheter shown in Figure 22A, taken in a plane perpendicular to the longitudinal axis of the delivery catheter; and

Figure 23 shows a schematic diagram of an exemplary dual-drawing filament system for the delivery catheters shown in Figures 20A-20E.

Detailed Implementation

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

This document describes implementations of deployment tools designed to facilitate the implantation of a prosthetic device (e.g., a prosthetic valve) in one of the natural mitral, aortic, tricuspid, or pulmonary valve regions of the human heart, and methods of using such deployment tools. The prosthetic device or valve may be an expandable transcatheter heart valve (“THV”) (e.g., a balloon-expandable, self-expandable, and/or mechanically expandable THV). Deployment tools can be used to deploy anchoring devices (sometimes referred to as docking devices, docking stations, or similar terms) that provide a more stable docking site for securing the prosthetic device or valve (e.g., THV) to the natural valve region. These deployment tools can be used to more precisely 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.

Figure 2A shows an example of such an anchoring device. Other examples of anchoring devices that may be used herein are shown in U.S. Patent Application Serials 15/643229, 15/684836, and 15/682287, each of which is incorporated herein by reference in its entirety. Anchoring devices described herein may be coiled or spiral, or they may include one or more coiled or spiral regions. The anchoring device 1 shown in Figure 2A includes two upper coils 10a, 10b and two lower coils 12a, 12b. In alternative embodiments, anchoring device 1 may include any suitable number of upper and lower coils. For example, 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. Additionally, 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, anchoring device 1 may have the same number of upper coils as it has lower coils. In other embodiments, the anchoring device 1 may have more or fewer upper coils compared to the lower coil.

The anchoring device may include coils/turns with varying or identical diameters, 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 extend radially outwards when the prosthetic valve is placed or expanded within the anchoring device 1.

In the exemplary embodiment of Figure 2A, the upper coils 10a, 10b may be substantially the same size as the lower coils 12a, 12b, or may have a diameter slightly smaller than that of the lower coils 12a, 12b. One or more lower end coils/turns (e.g., all or part of the end coils/turns) may have a larger diameter or a larger radius of curvature than the other coils and act as a surrounding coil/turn to help guide the end of the coil outward and around the leaflet and/or any chordae tendineae, for example, surrounding and corralling the leaflet and/or any chordae tendineae. One or more lower coils or surrounding coils with a larger diameter or a larger radius allow for easier engagement with the natural valve annulus during insertion and navigation around the natural valve anatomy.

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

Some of the coils may be functional coils (e.g., coils/turns between stabilizing coils (one or more)/turns and wrapping coils (one or more)/turns/turns), in which the prosthetic valve is deployed, and the forces between the functional coils and the prosthetic valve help hold each other in place. Anchoring devices and prosthetic valves may pinch natural 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 firmly hold them in place.

In one embodiment that may be the same as or similar to the anchoring device shown in Figures 9I–9U, the anchoring device has a large upper coil/turn or stabilizing coil/turn, a lower coil/turn or wrapping coil/turn, and multiple functional coils/turns (e.g., 2, 3, 4, 5 or more functional coils/turns).

For example, as shown in Figure 2C, when used for mitral valve placement, an anchoring device can be implanted such that one or more upper coils/turns (e.g., upper coils 10a, 10b) are above the natural valve annulus (e.g., mitral valve 50 or tricuspid valve), i.e., on the atrial side, and lower coils 12a, 12b are below the natural valve annulus, i.e., on the ventricular side. In this configuration, mitral leaflets 53, 54 can be trapped between upper coils 10a, 10b and lower coils 12a, 12b. When implanted, the various anchoring devices described herein provide a solid support structure to hold the prosthetic valve in place and prevent migration due to cardiac activity.

Figure 2B shows a general delivery device 2 for mounting an anchoring device on a natural mitral valve annulus 50 using a transseptal technique. The same or similar delivery device 2 can be used to deliver the anchoring device to the tricuspid valve without leaving the right atrium to cross the septum into the left atrium. The delivery device 2 includes an outer sheath or guiding sheath 20 and a flexible delivery catheter 24. The sheath 20 has an elongated, hollow tube-shaped axis through which the delivery catheter 24, along with various other components (e.g., the anchoring device, a prosthetic heart valve, etc.), can pass, thus allowing the components to be introduced into the patient's heart 5. The sheath 20 can be maneuverable, allowing it to bend at various angles required for it to pass through the heart 5 and enter the left atrium 51. When in the sheath 20, the delivery catheter 24 is in a relatively straight or extended configuration (compared to the curved configurations discussed in more detail below), for example, the delivery catheter 24 is held in the sheath 20 in a configuration or shape corresponding to the configuration or shape of the sheath 20.

Like the sheath 20, the delivery conduit 24 has an elongated, hollow tube-shaped shaft. However, the diameter of the delivery conduit 24 is smaller than that of the sheath 20, allowing it to slide axially within the sheath 20. Simultaneously, the delivery conduit 24 is large enough to accommodate and deploy anchoring devices, such as anchoring device 1.

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 this configuration. For example, as shown in Figure 2B, the flexible distal section 25 can be bent into a curved configuration, wherein the distal section 25 is bent to assist in extruding or pushing the anchoring device 1 on the ventricular side of the mitral valve 50, such that the lower coil (e.g., functional coil and/or surrounding coil) of the anchoring device 1 can be properly mounted below the natural valve annulus. The flexible distal section 25 can also be bent into the same or different curved configurations, such that the upper coil (one or more) of the anchoring device (e.g., stabilizing coil/turn or upper coils 10a, 10b) can be accurately deployed on the atrial side of the natural valve annulus. For example, the flexible distal section 25 can have the same configuration for mounting the upper coils 10a, 10b as for mounting the lower coils 12a, 12b. In other embodiments, the flexible distal section 25 may have one configuration for mounting the lower coils 12a, 12b and another configuration for mounting the upper coils 10a, 10b. For example, the flexible distal section 25 may be axially translated rearward from the above position to release the lower coils 12a, 12b, thereby releasing and positioning the upper coils 10a, 10b on the atrial side of the natural valve annulus.

In use, when accessing the mitral valve via a transseptal delivery method, 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 vascular system locations, and through the superior vena cava into the right atrium. As shown in Figure 2B, the interatrial septum 55 is then punctured (e.g., at the fossa ovalis), and the sheath 20 is inserted into the left atrium 51. (In the tricuspid valve procedure, puncture or crossing of the septum 55 is not required.) The sheath 20 has a distal portion 21, which may be a maneuverable or pre-bent distal portion to facilitate the manipulation of the sheath 20 into the desired chamber of the heart (e.g., the left atrium 51).

In a mitral valve procedure, with the sheath 20 properly positioned in the left atrium 51, the delivery catheter 24 is advanced from the distal end 21 of the sheath 20 such that the distal segment 25 of the delivery catheter 24 is also in the left atrium 51. In this position, the distal segment 25 of the delivery catheter 24 can be bent or curved into one or more curved or activated configurations 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 with sufficient strength and physical properties to push the anchoring device 1 through the delivery catheter 24. In some embodiments, the actuator may be made of or include: a spring or coil (e.g., see flexible tubes 87, 97 in Figures 17A-18C below), an extrusion structure, a braided tube, or other structures such as a laser-cut hypotube. In some embodiments, the actuator may have a coating on its top and/or inside; for example, the actuator may have an inner cavity lined with PTFE to allow a thread (e.g., a suture) to be actuated through the lined inner cavity in a damage-resistant manner. As described above, in some embodiments, after the actuator has pushed the ventricular coil of the anchoring device 1 into and properly positioned it in the left ventricle, the distal segment 25 may be translated axially rearward, for example, to release the atrial coil of the anchoring device 1 into the left atrium while maintaining or retaining the position of the ventricular coil of the device 1 within the left ventricle.

Once the anchoring device 1 is installed, the delivery catheter 24 can be removed by straightening or reducing the curvature of the flexible distal segment 25 to allow the delivery catheter 24 to return through the sheath 20. For example, as shown in FIG2C, with the delivery catheter 24 removed, a prosthetic valve, such as a prosthetic transcatheter heart valve (THV) 60, can then pass through the sheath 20 and be secured within the anchoring device 1, for example. When the THV 60 is secured within the anchoring device 1, the sheath 20, along with any other delivery device for the THV 60, can then be removed from the patient's body, and the openings in the patient's diaphragm 55 and right femoral vein can be closed. In other embodiments, after the anchoring device 1 is implanted, THV 60 can be delivered entirely independently using different sheaths or different delivery devices. For example, a guidewire can be introduced through the sheath 20, or the sheath 20 can be removed, and the guidewire can be advanced through the natural mitral valve and into the left ventricle using a separate delivery catheter via the same access point. Furthermore, even though the anchoring device is implanted transseptally in this embodiment, it is not limited to transseptal implantation, and the delivery of THV 60 is not limited to transseptal delivery (or more generally, via the same entry point as the delivery of the anchoring device). In other embodiments, after the transseptal delivery of the anchoring device 1, any of a variety of other entry points may be used thereafter to implant THV 60, for example, transapical, transcranial, or via the femoral artery.

Figure 3A shows a perspective view of an exemplary distal segment 25 that can be used in a delivery catheter 24. 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 for ease of description and understanding and are not intended to limit the orientation of the distal segment 25. The distal segment 25 of Figure 3A is formed as a generally cylindrical hollow tube that may include a plurality of connectors 38. Each connector 38 has a cylindrical segment shape, and each connector 38 is aligned and connected to adjacent connectors 38 to form the cylindrical tube shape of the distal segment 25. While the distal segment 25 is cylindrical in this embodiment, other shapes, such as an oval distal segment, are also possible. As best shown in Figure 3B, each connector 38 of the distal segment 25 may have a greater width at the bottom 29 than at the top 28, thereby providing an overall shape of the connector 38 as an acute trapezoid when viewed from the side. Each joint 38 may have a slit 39 at its bottom to allow the joint 38 to flex more relative to each other.

The distal segment 25 may include a dual guide pattern forming a mixed-bending segment comprising two side teeth 31, 32 and a top tooth 33. For this purpose, each connector 38 may include two side teeth 31, 32 and a top tooth 33 on opposite sides of the connector 38. As best shown in FIG3A, with respect to the distal segment 25, the two rows of side teeth 31, 32 of the connector 38 may extend the lengths of the sides 26, 27 of the distal segment 25, respectively, and the top tooth 33 may extend the length of the distal segment 25 on the top 28. Although in this example embodiment the rows of side teeth 31, 32 and top teeth 33 are shown extending straight along the length of the distal segment 25, other embodiments may have different configurations. For example, in some embodiments, the rows of side teeth 31, 32 and top teeth 33 may be spirally arranged around a tube of the distal segment 25, for example, as shown in FIG4, to achieve a specific bending shape of the distal segment 25 when it is actuated. In some embodiments, side teeth 31, 32 may be mirror images of each other to allow similar curvature on opposite sides 26, 27 of the distal segment 25. In other embodiments, side teeth 31, 32 may have different shapes and/or sizes compared to each other. Teeth 31, 32, 33 may present any other suitable shape and/or size that allows the distal segment 25 to move into a flexural configuration when the anchoring device is delivered. Although in the example embodiment teeth 31, 32, 33 are all right-facing teeth (e.g., pointing to the right in the view shown in FIG. 3B), in other embodiments, for example, the teeth may be left-facing teeth (see, for example, FIG. 4) or the top and side teeth may face different directions.

Each adjacent side tooth 31, 32 and each top tooth 33 corresponds to a side slot or groove 34, 35 and a top slot or groove 36 on the adjacent connector 38, respectively. Each slot 34, 35, 36 may have a shape complementary to its adjacent side tooth 31, 32 or top tooth 33. When the distal section 25 is in the extended configuration, the side teeth 31, 32 are partially inserted into the side slots 34, 35, and the top tooth 33 is separated from its adjacent top slot 36 by a gap. When the distal section 25 of the delivery conduit 24 is not fully flexed, the side teeth 31, 32 in this extended configuration are partially located within the side slots 34, 35 to provide additional torque resistance to the distal section 25. However, in other embodiments, when the distal section 25 is in the extended configuration, the side teeth 31, 32 may not be partially located within the side slots 34, 35.

When 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 before entering its corresponding top slot 36. When the distal segment 25 is in a fully flexed configuration, the combination of the top tooth 33 and the top slot 36 provides enhanced torque and torque resistance to the distal segment 25. Furthermore, when the distal segment 25 is adjusted from its straight configuration to its flexed configuration, the side teeth 31, 32 and the top tooth 33 all provide additional guidance control and structural support.

Figure 3B is a detailed cross-sectional view of several joints 38 of the distal segment 25 of Figure 3A. Figure 3B describes the side teeth 32, and this description also applies 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 lower than the top 28 of the distal segment 25. This positioning results in a smaller displacement of the side teeth 32; that is, the distance the side teeth 32 move into the adjacent slot 35 is much shorter or less than the distance 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 tooth 33 moves. In other words, the top tooth 33 moves a greater distance relative to the adjacent joint 38 when the distal segment 25 is adjusted to a fully curved configuration compared to the side teeth 31, 32. This arrangement allows for the use of shorter side teeth 31, 32 (e.g., side teeth with shorter longitudinal lengths), which can then be incorporated into shorter curved sections in the distal section 25.

Furthermore, since the tooth slots 34 and 35 are located in the wider lower portion of the coupling 38, the lower tooth line also provides more space for the wider tooth slots 34 and 35 to accommodate, for example, even larger side teeth. Larger and/or more suitable or robust tooth slots 34 and 35 with greater space to accommodate side teeth 31 and 32 can, for example, enhance the guidance of teeth 31 and 32 into the slots 34 and 35 during bending. The lower tooth line also allows for the robust tooth design discussed above, which still provides structural support when the coupling is bent away from each other—i.e., 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 torsional flexibility.

Figure 4 is a perspective view of the distal segment 25' in a curved configuration according to a modification of the first embodiment. The distal segment 25' in Figure 4 is similar to the distal segment 25 in Figure 3A, except that the rows of top teeth 33' and side teeth 31', 32' in Figure 4 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 spiral allows the distal segment 25' to bend in three dimensions, contrary to the single plane that appears in Figure 3A. As shown in Figure 4, the exemplary distal segment 25' has a three-dimensional curved shape. Various embodiments of the distal segment can be laser-cut (e.g., into sheets or tubes) such that the top and side teeth follow a pattern that will form the desired shape during bending. For example, patterns can be cut to create distal segments with curved shapes, which, when used in surgery, allow the distal segments to be positioned at the mitral valve or other valves, enabling the anchoring device to be advanced from the distal segments and accurately positioned at the valve.

The distal sections 25, 25' can be manufactured by cutting, for example, by laser cutting a flat metal strip or sheet to have a desired pattern, and then rolling the patterned metal strip or sheet into a hyaluronic acid tube. Alternatively, the desired pattern (e.g., a pattern identical or similar to the patterns shown in the figures herein) can be directly cut into a tube (e.g., a hyaluronic acid tube) without using a sheet or without having to roll the material. As an example, Figure 5 shows a plan view of an exemplary file or sheet 30 that can be used for laser cutting of the distal section 25 of Figure 3A. The laser-cut sheet 30 includes top teeth 33 and their associated slots 36 arranged in a straight line along the length of the distal section 25, as well as side teeth 31, 32 and their associated slots 34, 35. However, as mentioned above, in order to produce a distal segment 25' that is curved or spiral-shaped similar to that shown in Figure 4, 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 spirals. In other embodiments, various patterns can be cut that provide distal segments of other shapes or configurations that can help guide and deploy the anchoring device to the implantation site accurately during surgery.

Various types of sheets capable of being folded into tubes can be used to manufacture the cut distal sections. Furthermore, various types of tubes can be cut into desired patterns (one or more). For example, Nitinol and stainless steel, as well as various other suitable metals known in the art, can be used as materials for the sheets or tubes.

Although the above embodiments include top teeth and side teeth, such that each joint 38 has a total of three teeth, other embodiments may include only one of the top teeth or side teeth, or no teeth at all.

Figure 6 is a plan view of another exemplary laser-cut sheet 30” for the distal section 25” of the catheter delivery. The distal section 25” of Figure 6 is similar to the distal section 25” of Figure 5; however, the connector 38” of the distal section 25” includes only two side teeth 31, 32 and their associated slots 34, 35, and does not include any top teeth or corresponding slots.

Figure 7 is a plan view of another exemplary laser-cut sheet 30”’ for the distal section 25”’ of the catheter delivery. The distal section 25”’ of Figure 7 is also similar to the distal section 25 of Figure 5; however, each joint 38”’ of the distal section 25”’ includes only a single top tooth 33 and its associated slot 36, and does not include any side teeth or corresponding slots.

In other embodiments, each joint may include any combination of more or fewer than three teeth. Meanwhile, while Figures 6 and 7 show teeth arranged in a straight line along the length of the distal segments 25”, 25”’, respectively, the laser-cut sheets 30”, 30”’ can also be modified to include various tooth patterns and arrangements to allow the distal segments to bend in a specific desired shape, similar to what has been discussed above.

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 toward the commissure A3P3, allowing the coil anchor deployed from the catheter to more easily enter the left ventricle and encircle the chordae tendineae 62 during advancement. However, while the various exemplary embodiments of the 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 mitral valve plane toward the commissure A1P1, and the anchoring device can be advanced through the commissure A1P1. Additionally, the catheter can be bent clockwise or counterclockwise to approach the commissure of the mitral valve or the commissure of another desired natural valve, and the anchoring device can be implanted or inserted in a clockwise or counterclockwise direction (e.g., the coil/turn of the anchoring device can be rotated clockwise or counterclockwise depending on how the anchoring device will be implanted).

In a further embodiment, the catheter itself may also be positioned to pass beneath the plane of the natural valve annulus and to be situated in or extend into one of the commissures 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 allow the anchoring device to be positioned in any suitable manner at the implantation site. In some embodiments, when the catheter is positioned at the implantation site, the catheter itself may have a tip-proof design, for example, to provide protection against damage to the implantation site by reducing or eliminating any potential damage that may be caused by catheter advancement and/or shape manipulation.

While the above-described embodiments of the distal segment for catheter delivery include teeth and corresponding slots, other embodiments of the distal segment may not include teeth or corresponding slots. Figure 19 is a perspective view of another exemplary distal segment 25”” that can be used for catheter delivery. In this embodiment, the distal segment 25”” is a solid, generally cylindrical hollow tube made of a flexible material. The flexible material may 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 into a flexural configuration during delivery of the anchoring device. Although the exemplary 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 the anchoring device. Some embodiments of the distal segment may include linear slits and/or rectangular windows.

Figure 8 shows a perspective view of the curved or "hockey stick" configuration of the distal segment 65 of the delivery catheter 64. This configuration can be used to implant an anchoring device at a natural valve (e.g., at a natural 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 main subsections: a first flexural segment forming a shallow curved portion 66, a second flexural segment forming a circular or curved planar portion 67, a turn 68, and a flexible distal portion 69. The shape of these subsections allows the distal segment 65 to guide the delivery catheter 64 to a position at a natural valve (e.g., a natural mitral valve) and to accurately deploy the anchoring device at the natural valve (e.g., at the mitral valve location). The distal segment 65 can take any suitable form that allows the distal segment to adopt the aforementioned flexural configuration, such as, for example, any form described in this application. Although in the exemplary embodiment the distal section 65 of the delivery conduit 64 is bent in a clockwise direction, in other embodiments (e.g., as shown in the embodiments in Figures 9A-9U), the distal section 65 may instead be bent in the opposite, counterclockwise direction, for example, at the circular/curved planar portion 67 and/or the bend 68.

Figures 9A-9U illustrate another exemplary embodiment of the delivery device (which may be the same as or similar to other anchoring devices described herein), which delivers and implants the anchoring device (which may be the same as or similar to other anchoring devices described herein) at the patient's natural valve (e.g., at the patient's natural mitral valve 50 using a transseptal technique). Figure 9A is a cross-sectional view of the left atrium of a patient's heart, illustrating a sheath 20 (e.g., a guide sheath or transseptal sheath) that crosses the interatrial septum and enters the left atrium, and a delivery catheter 64 extending from the sheath 20, the crossing of the interatrial septum possibly occurring at the fossa ovalis (FO). Figure 9B illustrates the transseptal sheath 20 and delivery catheter 64 at the location shown in Figure 9A, viewed from the left atrium 51 looking down at the mitral valve 50 (i.e., from a view taken along line B-B in Figure 9A). Referring to Figure 9A, the sheath 20 enters 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 form described in this application.

In some embodiments, the sheath 20 may be actuated or manipulated such that it may be positioned or bent until it forms an angle (e.g., 30 degrees or approximately 30 degrees) relative to the diaphragm and/or FO wall. In some embodiments, the angular orientation (e.g., 30-degree orientation) may be adjusted or controlled by rotating or further actuating the sheath 20, and the angular orientation may 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 diaphragm and/or FO may be greater than or less than 30 degrees, depending on the specific case, and in some applications, it may even be oriented or bent at 90 degrees relative to the diaphragm and/or FO. In some embodiments, the deflection angle of the sheath can be moved between about 0 degrees and about 90 degrees, such as, for example, between about 5 degrees and about 80 degrees, between about 10 degrees and 70 degrees, between about 15 degrees and about 60 degrees, between about 20 degrees and about 50 degrees, between about 25 degrees and about 40 degrees, or between about 27 degrees and about 33 degrees.

Referring to Figures 9C-9D, after the outer sheath or guide sheath 20 passes through the diaphragm and/or FO and is positioned in the desired location, the delivery catheter 64 exits from the sheath 20 and extends. The delivery catheter is controlled such that it includes a distal end 65 having a circular or curved planar portion 67. In an exemplary embodiment, the distal end 65 of the delivery catheter 64 is moved such that it bends counterclockwise to create the circular/curved planar portion 67 (the anchoring device may also be coiled counterclockwise). In an alternative embodiment, the distal end 65 is moved such that it bends clockwise to create the circular/curved planar portion 67 (in these embodiments, the anchoring device may also be coiled clockwise).

Referring to Figures 9E-9F, the delivery catheter 64 also extends downward through a shallow, curved portion 66 of the distal end 65. As shown in Figure 9E, the delivery catheter 64 extends downward until the rounded/curved planar portion 67 of the distal end 65 approaches the plane of the mitral valve 50, which is typically about 30 to 40 mm below the FO wall. However, in some cases, the plane of the mitral valve may 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, 45 mm or less, 40 mm or less, 35 mm or less, 30 mm or less, 25 mm or less, or 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, or 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.

The circular/curved planar portion 67 is advanced or lowered to be located near, above, or substantially above the plane of the mitral valve 50. When lowered to or near the level of the annulus, the planar portion 67, or the plane of the planar portion 67, may be parallel or nearly parallel to the plane of the annulus (e.g., planar or nearly planar), or the planar portion 67 may be slightly angled upward relative to the plane of the annulus. The delivery catheter 64 is also curved to wind back toward the commissure A3P3. The delivery catheter 64 can be moved by any suitable means, such as, for example, a traction suture and loop system, or any other suitable method including those described in other parts of this application, to produce the circular/curved planar portion 67 and/or the shallow curved portion 66. Although the example implementation shows that the distal end 65 is moved to create a circular or curved planar portion 67 before the distal end is moved to create a shallow curved portion 66, it should be understood that extending the distal end 65 downward to create a shallow curved portion 66 can occur before the distal end 65 is bent counterclockwise to create a circular or curved planar portion 67.

Referring to Figures 9G-9H, the actuation point 70 (and/or one or more other actuation points) may be located between the shallow curved portion 66 and the circular/curved planar portion 67 that allows the distal segment 65 to be adjusted. In an exemplary embodiment, the actuation point 70 may be adjusted so that the planar portion 67 and the flexible end 69 are angled in a slightly downward direction, such that the flexible end 69 and the distal tip 907 extend below the annulus (or below the upper plane of the annulus) and/or enter the mitral valve 50 commissure A3P3 in the direction of the commissure A3P3. That is, the first actuation point 70 may be actuated such that the planar portion 67 (and therefore the flexible end 69) is angled downward toward the commissure A3P3 and positioned at or near (e.g., slightly extending into or through, such as 1-5 mm or less) the commissure. In addition to a further actuation point 70, or optionally, the delivery device (e.g., sheath and/or delivery catheter) may be twisted or rotated to angle the circular/curved planar portion 67 downward toward and/or into the junction as desired. Such twisting or rotation may sometimes be necessary to correct the angle if actuation of the curved 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 end 69.

Figure 9I illustrates an exemplary embodiment of a delivery catheter 64 in which the anchoring device 1 is deployed via a junction A3P3 and surrounds the chordae tendineae 62 and natural lobules in the left ventricle 52 of the patient's heart. The lower end of the anchoring device 1, or an anchoring device with a large diameter or radius of curvature, or a surrounding coil/turn, exits from the distal opening of the delivery catheter 64 and begins to present its shapeset or shape memory form in the direction of the circular or curved planar portion 67 of the delivery catheter 64.

To allow the anchoring device 1 to move through the mitral valve 50's shunt A3P3, the delivery conduit 64 is positioned such that the circular/curved planar portion 67 and the distal opening of the flexible end 69 of the delivery conduit 64 are angled downwards, and the distal opening of the flexible end 69 is oriented downwards and/or enters the shunt A3P3. Because the circular/curved planar portion 67 and the distal opening of the flexible end 69 are in the downward direction, the anchoring device 1 exits the delivery conduit 64 in the downward direction. After the anchoring device 1 exits the delivery conduit 64, the anchoring device 1 begins to bend to assume its shape setting or shape memory form. As illustrated in FIG9I, because the circular/curved planar portion is angled downwards, _the anchoring device 1 begins to bend upwards after approximately ^1/2 turn of deployment. To prevent the anchoring device 1 or its lower end/wrap/turn from engaging the mitral valve 50 in the upward direction as it is delivered away from the delivery conduit 64 (as shown in FIG. 9I), the delivery conduit 64 can be moved (e.g., by moving at the actuation point 70) once the anchoring device begins to wrap around the chordae tendineae 62, such that the circular/curved planar portion 67 is substantially parallel to the plane of the mitral valve 50 (see FIG. 9L). This can be accomplished as desired by actuating and/or twisting or rotating the delivery device or a portion thereof (e.g., the delivery conduit) at point 70 to adjust the angle of the planar portion 67.

Referring to Figure 9J, after the circular/curved planar portion 67 is moved to be substantially planar with the mitral valve annulus, the anchoring device 1 can be further deployed from the delivery catheter 64 such that the anchoring device is wound 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 upward and engaging the inferior side of the mitral valve annulus and/or the roof of the left ventricle.

Referring 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 retaining the heart valve. In an exemplary embodiment, the anchoring device 1 is arranged in the left ventricle 52 such that the three functional coils 12 of the anchoring device are tightly wound around the chordae tendineae and/or the natural leaflets. The lower end turns/coils or the surrounding turns/coils can be seen to extend slightly outward due to their larger radius of curvature. In some embodiments, the anchoring device 1 may comprise fewer or more than three coils 12 arranged around the chordae tendineae and/or the leaflets.

Figure 9L illustrates the delivery catheter 64 in the left atrium 51 after the coil 12 of the anchoring device is arranged around the chordae tendineae 62 and the natural leaflets (as shown in Figure 9K). In this position, the circular/curved planar portion 67 of the delivery catheter 64 is substantially parallel to the plane of the mitral valve 50, and the flexible end 69 is located at or near (e.g., slightly extended into or through, such as 1-5 mm or less) the commissure A3P3 of the mitral valve 50.

Referring to Figure 9M, as shown in Figures 9K-9L, after the delivery catheter 64 and anchoring device 1 are positioned, the delivery catheter is translated or retracted in the X direction along the axial direction of the anchoring device and enters the outer sheath 20. Translation or retraction of the delivery catheter can cause partial unsheathing and release of the anchoring device positioned on the atrial side of the natural valve (e.g., in the atrium) from the delivery catheter. For example, this can cause any upper portion of any functional coil and/or upper coil positioned on the atrial side of the natural valve (if present) to unsheath and be released. In one exemplary embodiment, the anchoring device 1 does not move or is substantially still when the delivery catheter is translated; for example, a pusher may be used to hold the anchoring device in place and/or inhibit or prevent retraction of the anchoring device when the delivery catheter is retracted.

Referring to Figure 9N, in an example instance, translation or retraction of the delivery catheter can also cause any upper coil/turn of the anchoring device 1 (e.g., a larger diameter stabilizing coil/turn) to exit/release from the delivery catheter. Due to the exit/release, the atrial side or upper coil of the anchoring device (e.g., a stabilizing coil with a larger diameter or radius of curvature) extends away from the delivery catheter 64 and begins to exhibit 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 can extend and/or bridge between the upper stabilizing coil/turn of the anchoring device and other coils/turns (e.g., functional coils/turns). In some embodiments, the anchoring device may have only one upper coil on the atrial side of the natural valve. In some embodiments, the anchoring device may include more than one upper coil on the atrial side of the natural valve.

Referring to Figure 9O, the delivery catheter 64 continues to translate back into the outer sheath or guide sheath 20, causing the upper portion of the anchoring device 1 to be released from the delivery catheter. The anchoring device is tightly connected to the actuator 950 by means such as sutures/threads 901 (other attachments or connection devices as shown in Figures 17A-18C may also be used). The upper coil/turn or stabilizing coil/turn is shown 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.

Referring to Figure 9P, the anchoring device 1 is completely removed from the lumen of the delivery conduit 64, and the slack is shown in the suture/thread 901 removably attached to the anchoring device 1, for example, the suture/thread 901 may loop through an eyelet at the end of the anchoring device. To remove the anchoring device 1 from the delivery conduit 64, the suture 901 is removed from the anchoring device. However, the position of the anchoring device 1 can be checked before removing the suture 901. If the anchoring device 1 is not in the correct position, it can be pulled back into the delivery conduit and redeployed using a pusher 950 (e.g., a push rod, push line, push tube, etc.).

Referring to Figure 9Q, after the delivery catheter 64 and outer sheath 20 are disengaged 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 may utilize one or more components of the delivery catheter 64 and/or the outer sheath or guiding sheath 20, or the delivery device 902 may be independent of the delivery catheter 64 and the outer sheath or guiding sheath. In an example embodiment, the heart valve delivery device 902 utilizes a transseptal approach to enter the left atrium 51.

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

Referring to Figure 9S, after the heart valve 903 is placed in the desired position, an optional balloon is inflated to expand the heart valve 903 to its expanded, deployed size. That is, the optional balloon is inflated such that the heart valve 903 engages the leaflet of the mitral valve 50 and forces the ventricular turns outward to an increased size to secure the leaflet 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 natural tissue and retain the heart valve 903 and the coil in the leaflet. In some embodiments, a self-expanding heart valve can be held 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, causing the heart valve to expand 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 expand by a combination of self-expanding and mechanical expansion).

Referring to Figure 9T, after the heart valve 903 is moved to its dilated state, the heart valve delivery device 902 and the filament 904 (still shown in Figure 9T) are removed from the patient's heart. The heart valve 903 is in a functional state and has replaced the function of the mitral valve 50 of the patient's heart.

Figure 9U shows a heart valve 903 in the left ventricle 52 as viewed from an upward angle along line U-U in Figure 9T. In Figure 9U, the heart valve 903 is in an expanded and functional state. In an exemplary embodiment, the heart valve 903 includes three valve components 905a-c (e.g., leaflets) configured to move between an open and a closed position. In alternative embodiments, the heart valve 903 may have more or fewer than three valve components configured to move between an open 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 exemplary embodiment, valve components 905a-c are shown in a closed position to prevent blood from moving from the left ventricle into the left atrium, the closed position being the position of the valve components during systole. During diastole, valve components 905a-c move to an open position, which allows blood to flow from the left atrium into the left ventricle.

Although the exemplary embodiments in Figures 9A-9U show a delivery catheter 64 for delivering the anchoring device 1 through the junction A3P3, it should be understood that the delivery device 64 may be configured and positioned to deliver the anchoring device 1 through the junction A1P1 such that the anchoring device 1 can be wound around the chordae tendineae in the left ventricle of the patient's heart. Furthermore, although the exemplary embodiments show a delivery catheter 64 for delivering the anchoring member 1 to the mitral valve and a heart valve delivery device 902 for delivering the heart valve 903 to the mitral valve 50, it should be understood that the anchoring device 1 and the heart valve 903 may be modified as necessary for repairing the tricuspid, aortic, or pulmonary valves.

In one embodiment, the distal section 65 of the delivery catheter 64 may be a solid, generally cylindrical hollow tube (e.g., distal section 25"" as shown in FIG19).

The guide sheath and/or distal segment of the various delivery catheters described 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 segment of the various delivery catheters described herein may have a dual pull wire system (e.g., the dual pull wire system described in Figures 20A-23). For example, the configuration shown in Figures 9A-9U, the "hockey stick" shaped configuration shown in Figure 8, or any other configuration described herein may also be achieved using a flexible catheter with two positioned pull rings located, for example, at or near the actuation points 70, 71 described above. The pull rings may engage or connect to corresponding pull wires. The pull wires may be positioned 90° away from each other in the circumferential direction around the delivery catheter. For example, a first pull loop positioned approximately halfway along the distal segment 65 can be actuated by a first pull wire to pull the distal region of the delivery catheter onto the plane of the natural valve (e.g., the mitral valve plane), while a second pull loop positioned further distally—at or near the distal tip 907 of the delivery catheter—can be actuated by another pull wire to bend the catheter in different directions, for example, around the plane of the natural valve (e.g., around the mitral valve plane) and toward the desired commissure (e.g., the mitral commissure A3P3), and further if necessary.

In some embodiments, the two pull loops may be connected by a ridge that is implemented on a radially opposite side of one of the traction wires, for example, opposite the traction wire of the distal pull loop. This added ridge can limit relative movement between the pull loops and helps to better control the direction of deflection caused by pulling the traction wire of the distal pull loop, and prevents the flexible distal segment from deflecting in a direction perpendicular to the mitral plane or in other unintended directions. While the above embodiments may include three pull loops and two traction wires, it should be understood that any number of pull loops and/or traction wires can be used to produce the various configurations described herein. Furthermore, it should be understood that any suitable number of ridges can be used to limit relative movement between the pull loops.

In some embodiments, the distal segment 65 may be a laser-cut hypotube arranged in a pattern such that, when bent, the distal segment forms any of the various configurations described herein (e.g., the configurations described in Figures 9A-9U, the "hockey stick configuration," etc.). Also as discussed, such a laser-cut distal segment may have actuation points that can be controlled, for example, by separate pull wires, two or more actuation points independent of each other, said pull wires being controlled, for example 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 bent configuration (e.g., one curve toward the mitral plane, and another curve being a circular portion generally bent around the mitral annulus).

In some embodiments, the entire distal section 65 does not need to be constructed as a laser-cut thiopanel tube. For example, the distal section 65 may include a first flexible straight section adjacent to a shallow curved portion 66, an optional small laser-cut bend portion forming the shallow curved portion 66 to help the distal region of the catheter bend onto the mitral valve plane, and a second flexible section extending to the distal tip, having the ability to bend along the mitral valve plane to point the distal end of the catheter toward the commissure A3P3. The first flexible section allows the distal section 65 to approach the mitral valve plane after exiting the transseptal sheath 20 and is flexible enough to be pushed and advanced through the sheath 20, but still rigid enough to resist the effects of the anchoring device as it is advanced and delivered through the catheter. The first flexible section may be constructed, for example, with a hardness of about 50D, of polyether block amide (PEBAX) coated on a coiled or braided tube. Meanwhile, the small laser-cut bend portion may have a maximum deflection of about 150° to assist in bringing the distal region of the catheter onto the mitral valve plane. Finally, similar to that already discussed above, the second flexible section may extend to the distal tip of the delivery catheter and is configured to flex so that the catheter points toward the junction A3P3, and potentially flex further to assist the anchoring device in circumferentially chordae tendineae. The second flexible section may also be constructed, for example, with PEBAX, which has a hardness of approximately 55D and is also reflowed over the coiled or braided tube. Using this construction, it is still possible to obtain a distal section 65 that is substantially similar to the laser-cut thiophanate-methyl tube described above, which is shaped and actuated, without having to form the entire distal section 65 as a laser-cut thiophanate-methyl tube, or any part thereof.

While a delivery conduit 64 having a distal segment 65 has been described using the above embodiments, it should be understood that the above embodiments are merely exemplary. The delivery conduit 64 may take any suitable form capable of producing the shape configuration described herein. Furthermore, the delivery conduit may be constructed using any suitable material capable of producing the shape configuration described herein.

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

In some embodiments, the distal segment 75 may be a fully laser-cut hypotube (similar to the laser-cut catheter described in Figures 4-7 above), wherein the cuts are arranged in a pattern such that the distal segment forms a helical configuration when bent. In some embodiments, the helical configuration of the laser-cut hypotube is allowed to be set as a helix stretched or extended to the plane of the natural valve annulus (e.g., stretched or extended from FO to a position below the mitral valve). The corresponding gap between the apical tooth and its associated slot (e.g., the slot is wider radially than the tooth, thus providing space for the tooth to move radially when it is in its corresponding slot) allows the catheter to undergo vertical stretching. The shape of the distal segment can be set with this vertical stretching configuration. Then, when the helix is in the mitral valve anatomy, the distal tip of the catheter can be pulled upward to position it along or just above the mitral valve plane, for example, by flexing or tightening the flexible filaments in or otherwise attached to the distal segment of the catheter discussed above. This feature allows the spiral to be adjusted to varying heights to accommodate different patient anatomy.

In another embodiment employing a delivery catheter 74 with a helical configuration, the distal segment 75 may not be constructed as a laser-cut thiocyanate tube, but instead may be formed as a coated coil. For example, the catheter may be formed from a tube braided or coiled with, for example, a low-durometer PEBAX coated thereon. When flexed, the catheter may form a helical configuration similar to that discussed above. Meanwhile, to control the height of the helix, a pusher wire may be included, extending along the axis of the delivery catheter and optionally connected to the distal end of the catheter. 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 plane of the natural valve annulus (e.g., the mitral valve plane). For example, the pusher wire may be NiTi wire, steel wire, or any other suitable wire. In one embodiment, when the distal end is below the plane of the natural valve annulus (e.g., below the mitral valve plane), pushing the pusher wire will lower the distal end of the helix, while pulling the pusher wire back will raise the distal end of the delivery catheter.

In another embodiment employing a delivery catheter 74 with a helical configuration, the distal segment may not be laser-cut or otherwise not cut at all (e.g., similar to distal segment 25"" shown in FIG. 19). For example, the distal segment 75 of the delivery catheter 74 may be formed of a flexible tubing configured with pull loops, pull wires, and/or ridges configured to move the delivery catheter 74 into the helical configuration.

Although the delivery catheter 74 having a distal section 75 has been described using the above embodiments, it should be understood that the above embodiments are merely exemplary. The delivery catheter 74 may take any suitable form capable of producing a helical configuration. In addition, the delivery catheter may be constructed with any suitable material capable of producing a helical configuration (e.g., the distal section 75 may take the form of the delivery catheter 114 shown in Figures 20A-23).

Figure 11 shows a perspective view of a hybrid configuration of the distal segment 105 of the delivery catheter 104. The delivery catheter 104 combines features from the aforementioned "hockey stick" and spiral configurations. In the hybrid configuration, similar to the "hockey stick" configuration, the distal segment 105 of the delivery catheter 104 first has a shallow curved or bent portion 106 to bend the catheter 104 toward the mitral valve plane. In an alternative embodiment, the catheter 104 is bent by increasing the proximal flexure of the bent portion 106. The shallow curved portion may be followed by a circular or curved planar portion 107, for example, beginning to bend in a counterclockwise direction as shown. In other embodiments, the delivery catheter 104 may instead be bent clockwise or curved (e.g., as shown in Figure 8). The planar portion 107 may be substantially parallel to the mitral valve plane.

Simultaneously, the distal end of the planar portion 107 is a flexible distal end portion 108, which may be bent, angled, or otherwise slightly downward pointing out of the plane in which the planar portion 107 is arranged, to more effectively direct the distal opening of the delivery conduit 104 toward or through the junction or other target. In some embodiments, the flexible distal end portion 108 may form a downward spiral region of the delivery conduit 104. The flexible distal end portion 108 may be deflected or displaced from the planar portion 107 in the vertical direction, 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 may be about 2 mm or greater, such as about 3 mm or greater, such as about 4 mm or greater, such as about 5 mm or greater, such as about 6 mm or greater, such as about 7 mm or greater, such as about 8 mm or greater, such as about 9 mm or greater, such as about 10 mm. Furthermore, in some embodiments, the flexible distal portion 108 (i.e., the downward spiral section) may 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 mitral valve plane.

Similar to the aforementioned delivery catheters, the distal segment 105 of the delivery catheter 104 may be made of or include: a laser-cut thiocyanate tube, a braided or coiled tubing, a flexible tube without incisions, or other flexible tubular structures. In some embodiments, the distal segment 105 of the catheter 104 may, for example, be coated with PEBAX. Furthermore, the distal end 105 of the delivery catheter 104 may be actuated or manipulated, for example, by shape settings, pull threads and/or loops, ridges, and/or by utilizing various other methods or features described in this application.

Meanwhile, although in the above embodiments the delivery device is generally or mostly positioned above the natural annular plane (e.g., the mitral valve plane), 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 advanced into the ventricle (e.g., through the commissure of the natural valve), in some other embodiments, at least a substantial portion of the delivery device itself may also be positioned in the left ventricle. For example, Figure 12 shows a delivery device for installing the anchoring device 1 at the natural mitral valve using a transseptal technique, wherein much of the distal end of the delivery device itself (e.g., the curved portion or actuable portion) is also advanced through the natural mitral valve and into the left ventricle.

Referring to Figure 12, the delivery device shown includes an external guiding sheath 20 and a flexible delivery catheter 114 that can be advanced through and exit the distal end of the guiding sheath 20. In the illustrated embodiment, for example, as shown in Figure 12, the guiding sheath 20 can first be manipulated through an opening formed in the interatrial septum (e.g., at the fossa ovalis) and into the left atrium. The guiding sheath 20 can then be manipulated downward in a curved or bent manner toward the natural mitral annulus, such that the distal opening of the guiding sheath 20 is substantially coaxial with the central axis of the mitral annulus. The vertical position of the guiding sheath 20 can be such that the distal opening of the guiding sheath 20 is substantially aligned with the natural mitral annulus, or it can be positioned in the left atrium, slightly above the natural mitral annulus, or in some embodiments (as shown in Figure 12), it can extend through the natural mitral annulus and into the left ventricle.

Once the guiding sheath 20 is positioned substantially as shown in FIG. 12, the delivery catheter 114 is then advanced outside the distal opening of the guiding sheath 20. In this embodiment, the distal end of the guiding sheath 20 is positioned at or slightly above the natural mitral annulus, such that the delivery catheter 114 can be initially advanced into the left atrium, just above the natural mitral annulus. The delivery catheter 114 can initially be advanced outside the distal opening of the guiding sheath 20 in an unacted, substantially straight configuration, and can subsequently be actuated into the curved configuration shown in FIG. 12 after being advanced outside the guiding sheath 20. In some embodiments, the delivery catheter 114 can be actuated into any other suitable configuration, such as, for example, any configuration described herein.

The flexible delivery catheter 114 may include two or more main deflectable segments, such as a distal segment 115 that can be bent into a curved configuration—its shape being relatively wide and rounded—to assist in shaping the anchoring device 1 as it is advanced outside the delivery catheter 114 and delivered to the implantation site, and a proximal segment 116 that forms a sharper bend (e.g., a bend of about 90 degrees) to assist in positioning the distal segment 115 in a plane substantially coplanar or parallel to the plane of the natural valve annulus (e.g., the mitral valve plane). The delivery catheter 114 may take any suitable form, such as, for example, any form described in this application.

Referring to Figures 13-16, in one exemplary embodiment, the distal region 117 of the exemplary delivery catheter 114 may be constructed from a hypotube having a first series of slots 125 and a second series of slots 126. The delivery catheter may also have a traction filament system (e.g., a dual traction filament system including a first traction filament 135 and a second traction filament 136). Figure 13 shows a schematic side view of the distal section 117 of an exemplary embodiment of the delivery catheter 114. Figure 14 shows a cross-sectional view of the multi-lumen extruded portion of the delivery catheter 114, taken in a plane perpendicular to the longitudinal axis of the delivery catheter, and Figures 15 and 16 show schematic perspective views of the delivery catheter 114 of Figure 13 in partially and fully actuated states, respectively. For example, as shown in any of the embodiments discussed above, other delivery catheters deployed and used in different ways may also be constructed with a similar dual traction filament system.

In one embodiment, the delivery catheter 114 has a distal region 117 including two flexible segments 115, 116. A first series of slots 125 may be arranged (e.g., linearly or otherwise) along a first side of the distal region 117 corresponding to and providing flexibility to the first flexible segment 115, such that when the delivery catheter is actuated, the first flexible segment 115 can form a generally circular configuration (e.g., it may resemble the configuration shown in FIG. 12). A second series of slots 126 may be arranged linearly along a second side of the distal region 117 corresponding to and providing flexibility to the second flexible segment 116, such that when the delivery catheter 114 is actuated, the second flexible segment 116 can form a sharper bend as shown in FIG. 12. Slots 125, 126 may be formed by laser cutting or in a manner similar to that described in previous embodiments, or may be formed in various other ways, provided that slots 125, 126, upon actuation, cause the delivery conduit 114 to be shaped as desired. The second series of slots 126 is positioned slightly adjacent to the first series of slots 125 corresponding to the bends of segments 115, 116, and may be offset circumferentially, for example, by about 90 degrees around the distal region 117, to allow for two orthogonal bends in the region, wherein the respective radii of curvature and articulation directions of segments 115, 116 may differ from each other. In some embodiments, segments 115, 116 may be offset circumferentially, 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.

In some embodiments, each of segments 115, 116 may have associated drawstrings 135, 136 for controlling the bending of segments 115, 116, respectively. Drawstring 135 may extend distally through slot 125 and may be attached to distal region 117 at connection point 135a and/or pull ring, for example by welding or other attachment methods. Similarly, drawstring 136 may extend distally through slot 126 and may be welded or otherwise attached to distal region 117 at connection point 136a and/or pull ring.

Simultaneously, proximally to the distal region 117, the delivery catheter 114 may include a proximal segment 140 that can be formed as a braided multilumen tube extrusion. As shown in the cross-section of FIG14, the proximal segment 140 of the delivery catheter 114 may 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 may be arranged to extend side-by-side through the central region of the proximal segment 140, and then exit distally from the proximal segment 140 and be attached to the sidewall of the distal region 117. When using the pull wires 135, 136, their central positioning through the proximal segment 140 provides an anti-whipping or anti-bending effect through the delivery catheter 114, allowing the delivery catheter 114 to maintain full torsion flexibility. However, in some implementations, the drawing wire is not centrally positioned, but extends from one end to the other along the sidewall or outer wall.

Additionally, the proximal segment 140 may have a main cavity 141. The main cavity may be centered when the drawing wire is not centered. Optionally, for example, when the drawing wire is centered, the main cavity 141 may be offset from the center of the extrusion structure. The main cavity 141 is sufficiently sized to allow the anchoring device to pass through and be delivered through it. The main cavity 141 may have, for example, an oval cross-section, a circular cross-section, or may have any other suitable cross-section shape, as long as the anchoring device 1 can be effectively advanced through it. In addition to the main cavity, for example, to affect the symmetrical moment of inertia around the drawing 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 it. In the illustrated embodiment, a first dummy lumen 142 is optionally diametrically positioned relative to the main delivery cavity 141 and forms a shape substantially the same as the main cavity 141 (e.g., oval in the example embodiment). Additionally, two optional dummy cavities 143 are diametrically positioned relative to each other and circumferentially positioned between cavities 141 and 142. Examples of additional dummy cavities 143 are slightly smaller than cavities 141 and 142 and have a more circular shape. In practice, the size and shape of the dummy cavities 143 can vary in other ways and are generally selected based on the respective dimensions of cavities 141 and 142 and the amount of remaining space in the extrusion structure. Furthermore, the main cavity 141 and the first dummy cavity 142 may also have variable sizes and shapes, depending on the specific application. Moreover, in some other embodiments, more or fewer than four total cavities may be formed in the proximal section 140 to achieve desired symmetry and rotational inertia, and to ensure uniform stiffness around the traction filament extending through the central axis of the proximal section 140.

Referring again to Figures 2B, 9A-9N, and 12, in practice, once the guiding sheath 20 is positioned or positioned as desired (e.g., across the diaphragm as shown or described elsewhere herein, e.g., 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 outside the distal opening of the guiding sheath 20. Before the delivery catheter is adjusted to its actuation configuration or final actuation configuration, a portion of the delivery catheter extending out of the guiding sheath 20 (e.g., catheter 114) may be positioned in the left atrium. In some cases, a portion of the delivery catheter may also extend through the natural mitral valve (e.g., as shown in Figure 12 or only slightly distally, such as 1-5 mm or less) into the left ventricle before the delivery catheter is adjusted to its actuation configuration or final actuation configuration. The traction wires 135 and 136 can then be tightened to actuate the distal region 117 and achieve, for example, an articulation of the two bends in segments 115 and 116 at the distal portion of the delivery catheter 114. For example, in one sequence, as shown in FIG15, the second traction wire 136 can be tightened first to bend segment 116 and position a portion of the delivery catheter 114 distal to segment 116, substantially planar and/or parallel to the natural valve annulus. Then, as shown in FIG16, the first traction wire 135 can be tightened to bend segment 115 into its circular or curved actuated state, such that the curvature of segment 115 is substantially planar and/or parallel to the natural valve annulus (e.g., with the mitral valve plane). In other embodiments, the traction wires 135 and 136 can be partially or completely tightened in different amounts and/or sequences to guide properly and safely around the patient's anatomy during actuation. For example, before actuating or bending segment 116 to lower and/or properly angle the curved planar portion or segment 115, segment 115 may be actuated and bent to form a circular or curved planar portion (e.g., similar to planar portion 67) (e.g., as described with respect to Figures 9A-9U). Following these actuation steps, in one embodiment, the distal region 117 of the delivery catheter 114 may be positioned entirely or substantially in the left atrium or on the atrial side of the natural valve.

In some cases, simply actuating 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. Twisting or rotating the delivery device or portions thereof (e.g., rotating the delivery catheter and/or guiding sheath) may be used as needed to angle the delivery catheter and its tip. For example, after the distal region 117 of the delivery catheter 114 is fully actuated or curved as needed (e.g., as described above), the assembly may be twisted and rotated to angle the tip of the delivery catheter 114 or to align it with or enter the commissure of a natural valve, for example, at the mitral valve commissure A3P3. The delivery catheter 114 may then be further twisted and rotated such 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 may then facilitate circumferential advancement of the distal tip of the delivery catheter 114 into the left ventricle to form a loop or be positioned around mitral valve anatomy such as the chordae tendineae, papillary muscles, and/or other features in the left ventricle. The design of the proximal segment 140 and the central arrangement of the traction filaments 135, 136 help provide anti-whiplashing or anti-bending effects through the delivery catheter 114 when manipulating the traction filaments 135, 136, allowing the delivery catheter 114 to maintain full torsionability through the septal bend and promoting more effective retention and maintenance of the actuated shape of the distal region 117 during this rotation step.

Referring to Figure 12, if the user selects to move the distal region of the catheter into the ventricle (e.g., the left or right ventricle), the movement of the delivery catheter 114 around the anatomical structures within 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 has been moved to the desired location around the chordae tendineae and other features within the ventricle, the first traction wire 135 can still be further tightened to reduce the radius of curvature of the circular segment 115, to cinch and gather the chordae tendineae and other natural anatomical structures passing through the center of the circular segment 115 and even further toward the center of the natural valve annulus. This radial tightening or gathering of the natural anatomical structures within the ventricle can subsequently help facilitate more robust delivery of the anchoring device 1—for example, by making it easier for the anchoring device 1 to advance around the gathered chordae tendineae and other features.

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 facilitates smoother and easier expulsion of the anchoring device 1 from the delivery catheter 114, as the curvature of the circular segment 115 can be formed to substantially approximate the final curvature of the anchoring device 1. Furthermore, the initial looping of the distal region 117 around at least a portion of the desired mitral valve anatomy in the left ventricle facilitates easier delivery of the anchoring device 1 to the outside and around the same anatomy that has already 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 methods discussed above—for example, by posteriorly axially translating the delivery catheter 114. This translation of the delivery catheter 114 can also help the delivery catheter 114 retract itself 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 traction wires 135, 136 can be released, and the delivery catheter 114 can be straightened and retracted through the guide sheath 20. Thus, similar to what was previously discussed, a prosthesis (e.g., a THV or other prosthetic valve) can be advanced into the anchoring device 1 and dilate within it.

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 and 114 described above. Any components, mechanisms, functions, elements, etc., of this embodiment (e.g., manipulation or actuation mechanisms or traction filament systems, traction filaments, loops, ridges, etc.) may be incorporated into other delivery catheters (and even guide sheaths) described herein. In the examples illustrated in Figures 20A-20E, 22, and 23, the distal region 117 of delivery catheter 114 may be constructed from a flexible tube 2030 (e.g., it may be the same as or similar to the flexible tube 25"" shown in Figure 19 or other tubes described herein). The delivery catheter has manipulation/actuation mechanisms or traction filament systems that can be used to actuate and bend the distal region of the catheter. The manipulation/actuation mechanism or traction wire system described herein may have one or more traction wires (e.g., 1-6 or more traction wires), one or more loops or pull rings (e.g., 1-7 or more loops), one or more ridges and/or other components.

In an example embodiment, the delivery catheter has a dual pull-wire system comprising a first pull-wire 2035, a second pull-wire 2036, three loops or loops (i.e., a first loop 2037, a second loop 2038, and a third loop 2039), a first ridge 2040, and a second ridge 2041. Figure 20A shows an end view of the distal segment 117 of the delivery catheter 114. Figure 20C is a cross-sectional view of the delivery catheter 114 of Figure 20A taken along the plane shown by line C-C. Figure 20B is a cross-sectional view of the delivery catheter 114 taken along the plane shown by line B-B. Figure 20D shows a cross-sectional view of the delivery catheter 114 taken along the plane shown by line D-D in Figure 20A. Figure 20E is a cross-sectional view of the delivery catheter 114 taken along the plane shown by line E-E in Figure 20A. Figures 21A and 21B are schematic perspective views of the delivery catheter 114 in its partially and fully actuated states, respectively, similar to the views in Figures 15 and 16. Figure 22A is a partial view of the delivery catheter 114. Figures 22B-22D show cross-sectional views of the delivery catheter taken along the planes shown by lines B-B, C-C, and D-D in Figure 22A, respectively. Figure 23 is a side view of the dual-pulling-wire system for the delivery catheter 114. Other delivery catheters or sheaths deployed and used in different ways, as shown in any of the embodiments described above, may also be constructed with similar dual-pulling-wire systems. Although the exemplary embodiments show a delivery catheter 114 with rings 2037, 2038, 2039 and ridges 2040, 2041, it should be understood that the delivery catheter 114 may be constructed with any number of rings and/or ridges, or without any rings or ridges.

In the example embodiment, the delivery conduit 114 has a distal region 117 comprising two flexible segments 115, 116. Referring to FIG. 20C, the first flexible segment 115 extends between a first ring 2037 and a second ring 2038. A first pull wire 2035 is attached to the first ring 2037 at connection point A, and actuation of the first pull wire 2035 causes the first flexible segment 115 to form a generally circular configuration as shown in FIGS. 11 and 12. Referring to FIGS. 20C and 20D and 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 stiffer material than the flexible tube 2030 and is therefore configured to restrict movement, such as compression, between the rings 2037, 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 conduit. The flexible conduit 2030 can be made of, for example, nitinol, steel and/or plastic, or any other suitable material or combination of materials that allows the delivery conduit 114 to be moved to a flexible configuration (e.g., the flexible configuration shown in Figure 12). In some embodiments, the ratio of the Shore D hardness of the ridge 2040 to the Shore D hardness of the flexible conduit 2030 is between about 3:1. In some embodiments, the ratio of the Shore D hardness of the ridge 2040 to the flexible conduit 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 alternative embodiments, the ratio of the Shore D hardness of the ridge 2040 to the flexible conduit 2030 is greater than 5:1 or less than 1.5:1.

In an exemplary embodiment, ridge 2040 is arranged substantially opposite to the first traction filament 2035, such that the center of ridge 2040 is circumferentially offset from the first traction filament 2035 by approximately 180 degrees. The center of ridge 2040 may be circumferentially offset from the first traction filament 2035 between approximately 70 degrees and approximately 110 degrees, such as between approximately 80 degrees and approximately 100 degrees, or between approximately 85 degrees and approximately 95 degrees. Referring to FIG. 22B, the width of ridge 2040 (defined by angle θ) may be any suitable width that allows delivery conduit 114 to move into the curved configuration shown in FIGS. 11 and 12. In some embodiments, the angle θ between the edges 2201, 2203 of ridge 2040 may be between approximately 45 degrees and approximately 135 degrees, such as between approximately 60 degrees and approximately 120 degrees, or between approximately 75 degrees and approximately 105 degrees, or between approximately 85 degrees and 95 degrees, or between approximately 90 degrees. A larger angle θ allows ridge 2040 more control over the movement of restraint rings 2037 and 2038 compared to a smaller angle θ. Ridge 2041 can be made of, for example, nitinol, steel and/or plastic, or any other suitable material or combination of materials.

Referring to Figure 20B, the second flexible section 116 extends between the second ring 2038 and the third ring 2039. A second draw wire 2036 is attached to the second ring 2038 at connection point B, and actuation of the second draw wire 2036 causes the second flexible section 116 to form the sharper bend shown in Figures 11 and 12. Referring to Figures 20B and 20E, and 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 material stiffer than the flexible tube 2030 and is therefore configured to restrict movement between the rings 2038 and 2039 when the second draw wire 2036 is actuated. The ridge 2041 can be made of, for example, stainless steel, plastic, or any other suitable material stiffer than the flexible tube. The flexible conduit 2030 may be made of, for example, nitinol, steel and/or plastic, or any other suitable material or combination of materials that allows the delivery conduit 114 to be moved into a flexible configuration (e.g., the flexible configuration shown in Figure 12). In some embodiments, the ratio of the Shore D hardness of the ridge 2041 to the Shore D hardness of the flexible conduit 2030 is between about 3:1. In some embodiments, the ratio of the Shore D hardness of the ridge 2041 to the flexible conduit 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 alternative embodiments, the ratio of the Shore D hardness of the ridge 2041 to the flexible conduit 2030 is greater than 5:1 or less than 1.5:1.

In an example embodiment, ridge 2041 is arranged substantially opposite to the second traction filament 2036, such that the center of ridge 2041 is circumferentially offset from the second traction filament 2036 by approximately 180 degrees. The center of ridge 2041 can be circumferentially offset from the second traction filament 2036 by between approximately 70 degrees and approximately 110 degrees, such as between approximately 80 degrees and approximately 100 degrees, or between approximately 85 degrees and approximately 95 degrees. Referring to FIG. 22C, the width of ridge 2041 (defined by angle β) can be any suitable width that allows delivery conduit 114 to move into the curved configuration shown in FIG. 12. In some embodiments, the angle β between the edges 2205, 2207 of ridge 2041 can be between approximately 45 degrees and approximately 135 degrees, such as between approximately 60 degrees and approximately 120 degrees, or between approximately 75 degrees and approximately 105 degrees, or between approximately 85 degrees and 95 degrees, or approximately 90 degrees. Compared to a smaller angle β, a larger angle β allows the ridge 2040 to have more control over the motion of the restraining rings 2037 and 2038 (i.e., increases the stiffness).

Referring to Figures 20D and 20E, the delivery catheter 114 includes a cavity 2032 sufficiently sized to deliver the anchoring device 1 through it, and the cavity 2032 is maintained sufficiently sized to deliver the anchoring device 1 when the first traction wire 2035 and the second traction wire 2036 are actuated to move the delivery catheter 114 into the curved configuration shown in Figure 12. The cavity 2032 may have, for example, an oval cross-section, a circular cross-section, or may have any other suitable cross-section shape, as long as the anchoring device 1 can be effectively advanced through the cavity 2032.

Connection point B for attaching the second traction wire 2036 to the second ring 2038 is positioned proximal to connection point A for attaching the first traction wire 2035 to the first ring 2037, and can be offset in the circumferential direction, for example, offset by about 90 degrees around the distal region 117. This 90-degree offset allows for two orthogonal bends in the region, where the respective radii of curvature and hinge directions of segments 115, 116 can be different from and independent of each other. In some embodiments, 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. Referring to Figures 20C and 20E, in some embodiments, wires 2035, 2036 extend along the length L of the delivery conduit 114 such that the wires are substantially parallel to the axis X extending through the center of the delivery conduit. In this embodiment, the threads 2035 and 2036 are offset in the circumferential direction such that the angle α between the threads 2035 and 2036 is between approximately 65 degrees and approximately 115 degrees, such as between approximately 75 degrees and approximately 105 degrees, such as between approximately 80 degrees and approximately 100 degrees, such as between approximately 85 degrees and approximately 95 degrees, such as approximately 90 degrees.

Referring to Figures 9A-9U and 20A-23, in practice, for example, in the positions shown, once the guide sheath 20 is positioned close to the natural valve annulus (e.g., mitral or tricuspid annulus), the distal region of the delivery catheter 114, including the distal region 117 (and in some embodiments, a portion of the proximal segment 2034), is advanced outside the distal opening of the guide sheath 20. At this point, the portion of the delivery catheter 114 extending out of the guide sheath 20 can be positioned in the atrium (e.g., left or right atrium), and in some cases, before the delivery catheter 114 is adjusted to its actuation configuration or, if previously partially actuated and adjusted to its full or final actuation configuration, the portion of the delivery catheter 114 may also extend slightly (e.g., 1-5 mm or less) through the natural valve (e.g., natural mitral valve) or the commissure of the natural valve into the ventricle (e.g., left or right ventricle). The traction wires 2035 and 2036 can then be tightened to actuate the distal region 117 and achieve articulation of the two bends in segments 115 and 116 at the distal portion of the delivery catheter 114. For example, in one sequence, as shown in FIG21A, the second traction wire 2036 can be tightened first to bend segment 116 and position a portion of the delivery catheter 114 distal to segment 116, which is substantially planar with the natural valve annulus (e.g., the natural mitral valve annulus). Then, as shown in FIG21B, the first traction wire 2035 can be tightened to bend segment 115 into its circular or curved actuated state, such that the curvature of segment 115 is substantially planar or parallel to the plane of the natural valve annulus (e.g., the mitral valve plane). In other embodiments, the traction wires 2035 and 2036 can be partially or completely tightened in different amounts and/or sequences to guide properly and safely around or relative to the patient's anatomy 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. Actuation of the pull wire or pull wire system can be used in combination with twisting or rotating the delivery device or a portion thereof (e.g., the delivery catheter or sheath) to point the distal region and distal tip of the catheter to a desired location and/or orient it.

For example, after the distal region 117 of the delivery catheter 114 is fully actuated or actuated to the desired configuration (as shown in FIG21B), the assembly can then be twisted and rotated such that the tip of the delivery catheter 114 is aligned with the commissure of the natural valve (e.g., the commissure of the natural mitral valve, such as at commissure A3P3). The delivery catheter 114 can be twisted and rotated such that the distal tip of the delivery catheter 114 points toward and/or into the commissure. Further rotation of the delivery catheter 114 may then facilitate circumferential advancement of the distal tip of the delivery catheter 114 toward and/or into the commissure, and/or change the direction from downward to a flatter (even) or parallel (or less downward) direction (e.g., after the first end of the anchoring device is pushed out or expelled from the delivery catheter), so that the end of the anchoring device does not undesirably rise and impinge or push against the underside of the valve annulus after insertion, allowing the anchoring device 1 to be looped or positioned around the exterior of natural anatomical structures such as chordae tendineae, papillary muscles and/or other features in the ventricle (e.g., the exterior of the natural mitral valve anatomy).

Referring to Figures 22A-22D and 23, in some embodiments, the delivery catheter 114 includes a first guide tube 2210 (e.g., a tube, cannula, etc.) for receiving a first traction wire 2035 and a second guide tube 2212 for receiving a second traction wire 2036. In an example embodiment, the guide tubes 2210, 2212 are at least partially defined by the lining 2215 and inner surface 2216 of the flexible tube 2030. In some embodiments, the guide tubes 2210, 2212 may take any other suitable form. In some embodiments, the guide tubes are not used to receive the traction wires 2035, 2036. When the traction wires 135, 136 are manipulated, the design of the proximal section 140 and the arrangement of the traction wires 2035, 2036 provide anti-whipping or anti-bending effects through the delivery catheter 114. This allows the delivery catheter 114 to maintain full torsion capability through the septal bend. This also facilitates more effective retention and maintenance of the actuated shape of the distal region 117 during twisting or rotation during delivery. In some embodiments, the delivery catheter 114 includes a first coiled sheath 2211 extending around a first traction wire 2035 until it reaches a first flexure section 115, and a second coiled sheath 2213 extending around a second traction wire 2036 until it reaches a second flexure section 116. The coiled sheaths 2211 and 2213 are configured to provide anti-whipping or anti-bending effects and to maintain the full torsionability of the delivery catheter 114.

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

When the delivery catheter is used in the ventricle to surround natural anatomical structures, the anchoring device 1 can be advanced outside 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 facilitates a smoother and easier expulsion of the anchoring device 1 from the delivery catheter 114, as the curvature of the circular segment 115 can be formed to substantially approximate the final curvature of the anchoring device 1. Furthermore, the distal region 117 initially loops around at least part of the desired mitral valve anatomy in the left ventricle, facilitating easier delivery of the anchoring device 1 to the outside and around the same anatomy that has already 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 methods discussed above—for example, by posteriorly axially translating the delivery catheter 114. This translation of the delivery catheter 114 also helps it retract itself 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 traction wires 2035, 2036 can be released, and the delivery catheter 114 can be straightened and retracted through the guide sheath 20. Thereafter, similar to what has been previously discussed, a THV or other prosthetic valve can be advanced into the anchoring device 1 and dilate within it.

In some embodiments (e.g., any embodiment of the delivery catheter described in this application), a damage-resistant tip 118 may also be formed at the distal end of the distal region 117 to prevent or reduce potential damage to the guide sheath 20 or the patient's anatomy as the delivery catheter 114 is advanced and manipulated to its desired location and orientation. The damage-resistant tip 118 may be an extension of the distal region 117 formed in a circular or other damage-resistant shape, or may be, for example, an addendum formed of a different material than the distal region 117, such as an additional braided layer and/or made of a lower-stiffness material.

Optionally, the anchoring or docking device may also include a low-friction cannula, such as a PTFE cannula, which fits around all or part of the anchoring or docking device (e.g., the lead turn and/or functional turn). For example, the low-friction cannula may include a lumen in which the anchoring device (or a portion thereof) fits. The low-friction cannula makes 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 abrasion or damage to the native tissue. After the anchoring device is properly positioned in the native valve, the low-friction cannula may be removable (e.g., by pulling proximally on the cannula while holding the pusher and anchoring device in place), thereby exposing, for example, a portion that may be configured (porous, braided, large surface area, etc.) to promote tissue inward growth or the surface of the anchoring device including that portion.

The delivery catheter configuration described herein provides an exemplary implementation that allows for the accurate positioning and deployment of the anchoring device. However, in some cases, retrieval or partial retrieval of the anchoring device at any stage during or after deployment remains necessary, for example, to reposition the anchoring device at a natural valve or to remove the anchoring device from the implantation site. The following embodiments describe various locking or locking release mechanisms that can be used to attach and/or detach the anchoring device or docking device from a deployment pusher that ejects the anchoring device from the delivery catheter. Other locking or locking mechanisms are also possible, for example, as described in U.S. Provisional Patent Application Serial No. 62/560,962, filed September 20, 2017, which is incorporated herein by reference. The anchoring device may be attached proximally to the pusher or by other mechanisms that allow it to be pushed, pulled, and easily detached.

In previous examples, the stitches or thread of the pusher or pusher tool pass through an opening or eyelet in the end of the anchoring device to retain the anchoring device and allow it to be retracted and released. Figures 17A-17C show perspective views of the proximal end 82 of an exemplary anchoring device 81 and a ball locker or locking mechanism 84. As shown in Figure 17A, the anchoring device 81 can be similar to the anchoring device embodiments described above, 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 the ball locking mechanism 84 includes a pusher 85 (which may be the same as or similar to other pushers herein with necessary modifications) and a pull wire 86 that interacts with the locking tube 83. The pusher 85 includes a flexible tube 87, which, although shown as cut away in Figures 17A-17C, can be long enough to extend through the delivery conduit during deployment of the anchoring device 81. The pull wire 86 extends through the actuator 85 and may also extend through the length of the locking tube 83 of the anchoring device 81, protruding through the distal end of the actuator 85. The actuator 85 has a distal end 88 and a short wire 89 connected to and/or extending from the actuator end 88. The distal end of the short wire 89 includes a spherical ball 90.

As shown in Figure 17B, the locking tube 83 at the proximal end 82 of the anchoring device 81 is sized to receive a spherical ball 90 through which a short filament 89 passes. The locking tube 83 is a short tube that can be welded to or otherwise attached to the proximal end of the anchoring device 81 (oriented during delivery). The inner diameter of the locking tube 83 is slightly larger than the outer diameter of the spherical ball 90, allowing the ball 90 to pass through. The lock or locking mechanism is based on the relative diameters of the inner diameter of the locking tube 83, the diameter of the ball 90, and the diameters of the other portions of the short filament 89 and the diameter of the pulling wire 86.

After the ball 90 passes through and exits the distal end of the locking tube 83, locking can be achieved by preventing the ball 90 from threading back through the locking tube 83 and releasing from it. This can also be achieved by inserting the pull wire 86 into the locking tube 83. As shown in Figures 17C-17D, when the thinner portions of both the short wire 89 and the pull wire 86 are threaded into and positioned within the locking tube 83, the ball 90 is prevented from threading back through the locking tube 83, thus locking the anchoring device 81 to the pusher 85. As best shown in Figure 17D, when the pull wire 86 is in the locking tube 83, it prevents the short wire 89 from moving to a more central position within the hole of the locking tube 83, preventing the ball 90 from aligning with the locking tube 83 and retracting away from it. Therefore, when the pusher 85 is pulled from the distal end of the locking tube 83 towards the proximal end, the ball 90 abuts against the distal end of the locking tube 83. In this locked position, the pusher 85 is locked to the anchoring device 81, and the pusher 85 can push or pull the anchoring device 81 to more accurately position it during the procedure. Only when the traction wire 86 is pulled back away from 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, thus unlocking or disconnecting the anchoring device 81 from the pusher 85. Simultaneously, retracting the traction wire 86 to unlock the anchoring device 81 requires only a relatively small pulling force, as the locking force relies primarily on the short wire 89, which bears most of the load when the mechanism is locked.

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 about 10 mm to remove it from the locking tube 83 and allow the ball 90 to release. In other embodiments, the anchoring device 81 can 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, between about 8 mm and about 12 mm, or between about 9 mm and about 11 mm. In some embodiments, the anchoring device 81 can be unlocked from the pusher 85 by retracting the pull wire 86 less than 6 mm or more than 14 mm. The embodiments of Figures 17A-17D provide a robust and reliable locking mechanism that can achieve strong locking force while requiring only a small pulling force to unlock the components and disengage them from each other.

In use, prior to implantation, for example, as shown in Figure 17C, the ball locking mechanism 84 can be assembled with the anchoring device 81. After positioning the distal segment of the delivery catheter at or near the natural valve annulus (e.g., at the mitral valve annulus), the pusher 85 can be used to push the anchoring device 81 through the delivery catheter to deploy the anchoring device 81, utilizing one of the techniques described above with respect to Figures 8, 9A-9U, and 10. The user can then use the pusher 85 to further retract and/or advance the anchoring device 81 at the natural valve annulus to more accurately position the anchoring device 81 at the implantation site. As shown in Figure 17B, once the anchoring device 81 is accurately positioned, the traction wire 86 can be retracted from the locking tube 83, and as shown in Figure 17A, the ball 90 can then be retracted and released from the locking tube 83, thereby disengaging the anchoring device 81 from the ball locking mechanism 84. The pusher 85 can then be removed from the implantation site.

Figures 18A-18C show perspective views of the proximal end 92 and the ring locking mechanism 94 of an anchoring device 91 according to an embodiment of the present invention. As shown in Figure 18A, the anchoring device 91 can be similar to the anchoring device embodiment described above, with the addition of a modified proximal end 92. 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 a delivery conduit during 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 length of the pull wire 96 engaging the wire loop 99 to protrude through the distal end of the pusher 95. The pusher 95 has a distal tip 98 and a wire loop 99 connected to and/or extending from the pusher tip 98. In this embodiment, the ring 99 extends distally from the distal end 98 of the actuator 95 and has a distal ring portion extending generally perpendicular to the longitudinal axis of the actuator 95. Although the threaded ring 99 is shown as a thread, such as a cylindrical metal wire, in this embodiment, the invention is not limited thereto. In other embodiments, the ring 99 may also be made of, for example, a flat metal piece or other material, which may be laser-cut, formed by using stitching, or may take any other suitable form that allows it to enter the slot 93 of the anchoring device 91 and receive the pull thread 96 to secure the anchoring device 91 to the actuator 95.

As shown in Figure 18B, the hole 93 at the proximal end 92 of the anchoring device 91 is sized to receive the end of the thread loop 99. When the thread loop 99 is inserted into and passes through the hole 93, the end of the thread loop 99 extends out of the opposite side of the hole 93, exposing or protruding from the opposite side. As shown in Figure 18C, the ring 99 should be able to protrude from the opposite side of the hole 93 by an amount sufficient to allow the pulling thread 96 to be inserted into or threaded through the ring 99. Then, as shown in Figure 18C, by passing the pulling thread 96 through the ring 99, the anchoring device 91 can be attached to or engaged with the pusher 95 in a locked position, wherein the pusher 95 can push or pull the anchoring device 91 to more accurately position the anchoring device 91 during the procedure. In this locked position, the pulling thread 96 anchors the ring 99 in place and prevents the ring 99 from retracting out of the hole 93. Only when the pull wire 96 is pulled back away from the ring 99 can the ring 99 disengage from the hole 93, and the anchoring device 91 be unlocked or disconnected from the pusher 95. At the same time, retracting the pull wire 96 to unlock the anchoring device 91 requires only a relatively small pulling force, because the locking force mainly depends on the ring 99, which bears most of the load when the mechanism is locked.

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, on the one hand, to protrude from one side of the hole 93 opposite the insertion side, to allow sufficient space for the pull wire 96 to pass through, and on the other hand, short enough to reduce vertical displacement during locking, thus maintaining a tight connection between the pusher 95 and the anchoring device 91. Therefore, the embodiments in Figures 18A-18C also provide a robust and reliable locking mechanism that can achieve a strong locking force while 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 only involve retracting the pull wire 96 by about 10 mm to remove the pull wire 96 from the ring 99 and allow the ring 99 to release. In other embodiments, the anchoring device 91 can be unlocked from the pusher 95 by retracting the pull wire 96 to between approximately 6 mm and approximately 14 mm, such as between approximately 7 mm and approximately 13 mm, between approximately 8 mm and approximately 12 mm, or between approximately 9 mm and approximately 11 mm. In some embodiments, the anchoring device 91 can be unlocked from the pusher 95 by retracting the pull wire 86 to less than 6 mm or more than 14 mm.

In use, prior to surgery, as shown in Figure 18C, the ring locking mechanism 94 can be assembled together with the anchoring device 91. Using one of the techniques described above with respect to Figures 8, 9A-9U, and 10, after positioning the distal segment of the delivery catheter at or near the natural 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 natural valve annulus to more accurately position the anchoring device 91 at the implantation site. As shown in Figure 18B, once the anchoring device 91 is precisely positioned, the traction suture 96 can retract away from the ring 99, and as shown in Figure 18A, the ring 99 can then retract away from the orifice 93, thereby disengaging the anchoring device 91 from the ring locking mechanism 94. The pusher 95 can then be removed from the implantation site.

Other actuators and retrieval devices, as well as other systems, devices, components, methods, etc., are disclosed in U.S. Provisional Patent Application Serial No. 62/436,695, filed December 20, 2016, and U.S. Provisional Patent Application Serial No. 62/560,962, filed September 20, 2017, and the related PCT patent application entitled “SYSTEMS AND MECHANISMS FOR DEPLOYING A DOCKING DEVICE FOR A REPLACEMENT HEART VALVE,” filed December 15, 2017 (claiming priority to the aforementioned provisional applications), each of which is incorporated herein by reference in its entirety. With necessary modifications, any embodiments and methods disclosed in the foregoing applications may be used in conjunction with any embodiments and methods disclosed in this application.

The various manipulations and controls of the systems and devices described herein can be automated and/or mechanized. For example, the aforementioned controls or knobs can be buttons or electrical inputs that arouse the actions described with respect to the controls/knobs above. This can be accomplished by connecting some or all moving parts (directly or indirectly) to a motor (e.g., an electric motor, pneumatic motor, hydraulic motor, etc.) actuated by the button or electrical input. For example, a motor can be configured, when actuated, to tighten or loosen the control wire or traction wire described herein to move a distal region of the catheter. Additionally or alternatively, a motor can be configured, when actuated, to move a actuator translationally or axially relative to the catheter to move and/or move an anchoring or docking device within the catheter into or out of the catheter. Automatic stopping or preventative measures can be established to prevent damage to the system/device and/or the patient, for example, to prevent component movement beyond a certain point.

It should be noted that the devices and equipment described herein can be used with other surgical procedures and access points (e.g., transapical, direct cardiac visualization, etc.). It should also be noted that the devices described herein (e.g., deployment tools) can also be used in combination with a variety of other types of anchoring devices and/or prosthetic valves, different from the examples described herein.

For the purposes of this specification, certain aspects, advantages, and novel features of embodiments of this disclosure are described herein. The disclosed methods, apparatuses, and systems should not be construed as limiting in any way. Rather, this disclosure relates to all novel and non-obvious features and aspects of the various disclosed embodiments (individually and in various combinations and sub-combinations of each other). The methods, apparatuses, and systems are not limited to any particular aspect or feature or combination thereof, and the disclosed embodiments do not require that any one or more particular advantages should exist or that any problem should be solved. Features, elements, or components of one embodiment may be incorporated into other embodiments herein.

For ease of presentation, although some disclosed embodiments are described in a specific order, it should be understood that this descriptive approach includes rearrangement unless a particular language requires a specific order. For example, the sequentially described operations may be rearranged or performed simultaneously in some cases. Furthermore, for brevity, the accompanying drawings may not show the various ways in which the disclosed methods can be combined with other methods. Additionally, the description sometimes uses terms such as “provide” or “implement” 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 specific implementations and are readily discernible to those skilled in the art. The steps of the various methods described herein can be combined.

Given the many possible implementations to which the principles of this disclosure can be applied, it should be recognized that the exemplary embodiments are merely preferred examples of the invention and should not be considered as limiting the scope of this disclosure. Rather, the scope of this disclosure is defined by the appended claims.

Claims (36)

1. A delivery catheter for delivering a device to a patient's heart valve, comprising: A flexible tube having a main lumen and a control wire lumen, wherein the 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 hole extending between the first end and the second end, the hole being sized to allow an anchoring device to pass through it. Each joint is aligned with and connected to the adjacent joint and has a top tooth, side teeth, and a corresponding slot, wherein the slot of each joint has a shape complementary to the side teeth or top teeth of the adjacent joint; and Each joint has a wider base than its top, such that when viewed from the side, each joint has an acute-angled trapezoidal shape; and A control wire in a control wire conduit, the control wire being connected to the distal region of the flexible tube; The tension applied to the control wire causes the distal region of the flexible tube to bend; and Each joint includes at least one slot at its bottom to allow the joint to flex more relative to each other. 2. The delivery catheter of claim 1, wherein each connector is connected to the adjacent connector at the bottom of the connector. 3. The delivery catheter of claim 1, wherein when a pulling force is applied to the control wire to bend the distal region, the top of the connector moves a greater distance. 4. The delivery catheter of claim 1, wherein the plurality of joints are in a straight configuration when the tension is removed from the control wire. 5. The delivery catheter of claim 1, wherein the distal segment of the delivery catheter is coated with PEBAX. 6. The delivery catheter of claim 5, wherein the distal segment of the delivery catheter is composed of at least one of nitinol, stainless steel or plastic. 7. The delivery catheter of claim 1, wherein the control wire comprises a first control wire and a second control wire, and the delivery catheter comprises a first loop located in a distal region of the flexible tube and a second loop located in the distal region of the flexible tube, the second loop being spaced apart from the first loop, wherein the first control wire is movably coupled to the first loop at a first actuation point, and the second control wire is movably coupled to the second loop at a second actuation point. 8. The delivery catheter of claim 1, wherein the connector is cut from a single tube. 9. The delivery catheter of claim 1, wherein the connector is cut from a single flat sheet, the single flat sheet being rolled to form the connector. 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: 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 sheath disposed within the control wire cavity surrounding the control wire. 13. The delivery catheter of claim 12, wherein the coil sheath extends from the distal region of the flexible tube to the proximal region such that the portion of the control wire extending from the second loop to the first loop is not covered by the coil sheath. 14. A delivery catheter for delivering a device to a patient's heart valve, comprising: A flexible tube having a main lumen and a control wire lumen, wherein the 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 hole extending between the first end and the second end, the hole being sized to allow an anchoring device to pass through it. The 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 located in a control wire conduit, the control wire being connected to the first loop; and A coil sleeve, the coil sleeve being arranged in a control wire cavity surrounding the control wire; The coil sleeve extends from the distal region of the flexible tube to the proximal region, such that the portion of the control wire extending from the second loop to the first loop is not covered by the coil sleeve. The tension applied to the control wire causes the distal region of the flexible tube to bend; and Each joint includes at least one slot at its bottom to allow the joint to flex more relative to each other. 15. The delivery catheter of claim 14, wherein each connector is connected to an adjacent connector at the bottom of the connector. 16. The delivery conduit of claim 14, wherein each connector has a greater width at the bottom than at the top, such that each connector has an acute-angled trapezoidal shape when viewed from the side. 17. The delivery catheter of claim 16, wherein when a pulling force is applied to the control wire to bend the distal region, the top of the connector moves a greater distance. 18. The delivery catheter of claim 14, wherein the plurality of joints are in a straight configuration when the tension is removed from the control wire. 19. The delivery catheter of claim 14, wherein the distal segment of the delivery catheter is coated with PEBAX. 20. The delivery catheter of claim 19, wherein the distal segment of the delivery catheter is composed of at least one of nitinol, stainless steel, or plastic. 21. The delivery catheter of claim 14, wherein the control wire comprises a first control wire and a second control wire, wherein the first control wire is movably coupled to the first loop at a first actuation point, and the second control wire is movably coupled to the second loop at a second actuation point. 22. The delivery catheter of claim 14, wherein the plurality of joints are cut from a single tube such that each joint is aligned with and connected to an adjacent joint and has a top tooth and side teeth and a corresponding slot, and the slot of each joint has a shape complementary to the side teeth or top teeth of the adjacent joint. 23. The delivery catheter of claim 14, wherein the plurality of connectors are cut and rolled from a single flat sheet such that each connector is aligned with and connected to an adjacent connector and has a top tooth and side teeth and a corresponding slot, and the slot of each connector has a shape complementary to the side teeth or top teeth of the adjacent connector. 24. The delivery catheter of claim 22, wherein the control wire is capable of extending distally through the slot and is capable of being attached to the distal segment by welding at least at one connection point in the distal segment. 25. A delivery catheter for delivering a device to a patient's heart valve, comprising: A flexible tube having a central main lumen and a control wire lumen, wherein the 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 hole extending between the first end and the second end, the hole being sized to allow an anchoring device to pass through it. The 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 located in a control wire conduit, the control wire being connected to the first loop; The plurality of cylindrical joints are cut from a single sheet of material such that each joint is aligned with and connected to adjacent joints and has a top tooth, side teeth, and a corresponding slot, wherein the slot of each joint has a shape complementary to the side teeth or top teeth of the adjacent joint; and A coil sleeve, the coil sleeve being arranged in the control wire cavity surrounding the control wire; The coil sleeve extends from the distal region of the flexible tube to the proximal region, such that the portion of the control wire extending from the second loop to the first loop is not covered by the coil sleeve. The tension applied to the control wire causes the distal region of the flexible tube to bend; and Each joint includes at least one slot at its bottom to allow the joint to flex more relative to each other. 26. The delivery catheter of claim 25, wherein each connector is connected to the adjacent connector at the bottom of the connector. 27. The delivery conduit of claim 25, wherein each connector has a wider width at the bottom than at the top, such that each connector has an acute-angled trapezoidal shape when viewed from the side. 28. The delivery catheter of claim 27, wherein when a pulling force is applied to the control wire to bend the distal region, the top of the connector moves a greater distance. 29. The delivery catheter of claim 25, wherein the plurality of joints are in a straight configuration when the tension is removed from the control wire. 30. The delivery catheter of claim 25, wherein the distal segment of the delivery catheter is coated with PEBAX. 31. The delivery catheter of claim 30, wherein the distal segment of the delivery catheter is composed of at least one of nitinol, stainless steel or plastic. 32. The delivery catheter of claim 25, wherein the control wire comprises a first control wire and a second control wire, wherein the first control wire is movably coupled to the first loop at a first actuation point, and the second control wire is movably coupled to the second loop at a second actuation point. 33. The delivery catheter of claim 25, wherein the connector is cut from a single tube. 34. The delivery catheter of claim 25, wherein the connector is cut from a single flat sheet, the single flat sheet being rolled to form the connector. 35. The delivery catheter of claim 30, wherein the control wire is capable of extending distally through the slot and is capable of being attached to the distal segment by welding at least at one connection point in the distal segment. 36. The delivery catheter of claim 25, wherein the control wire is capable of being attached to an anchoring ring, the anchoring ring being positioned at or distal to a first end.