Implant delivery systems

Abstract

The delivery catheter, in various embodiments, is configured to deliver an anchoring device to an annulus of a native valve in a patient's heart, where the anchoring device can better secure a prosthesis to the native valve annulus. Example delivery catheters may be configured to deflect toward the ventricle during deployment of the anchoring device. Examples of docking coil sleeves and docking coils are disclosed herein.

Description

[Technical field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of U.S. Provisional Patent Application No. 63 / 174,712, filed April 14, 2021, the entire contents of which are incorporated herein by reference.

[0002] The present disclosure relates generally to deployment tools for delivering anchoring devices, such as prosthetic docking devices that support prostheses and methods of using the same. For example, the present disclosure relates to replacement of deformed and / or dysfunctional heart valves utilizing a delivery catheter to deploy anchoring devices that support a prosthetic heart valve at an implantation site, and methods of implanting such anchoring devices and / or prosthetic heart valves using a delivery catheter. [Background technology]

[0003] 1A-1B, a native mitral valve 50 controls blood flow from the left atrium 51 to the left ventricle 52 of the human heart, and similarly, a tricuspid valve 59 controls blood flow between the right atrium 56 and the right ventricle 61. The mitral valve has a different anatomical structure than other native heart valves. The mitral valve includes an annulus of native valve tissue surrounding the mitral orifice and a pair of cusps or leaflets extending downward from the annulus into the left ventricle. The mitral valve annulus can form a "D"-shaped, elliptical, or otherwise non-circular cross-sectional shape with major and minor axes. The anterior leaflet of the valve is larger than the posterior leaflet and can form a generally "C"-shaped boundary between the abutting free bilateral edges of the leaflets when they are closed together.

[0004] When operating properly, the anterior leaflets 54 and posterior leaflets 53 of the mitral valve function 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 left atrial muscle contracts and the left ventricle relaxes (also called "ventricular diastole" or "diastole"), allowing the oxygenated blood collected in the left atrium to flow into the left ventricle. The left atrial muscle then relaxes and the left ventricular muscle contracts (also called "ventricular systole" or "systole"), moving the oxygenated blood from the left ventricle 52 through the aortic valve 63 and the aorta 58 to the rest of the body. When blood pressure in the left ventricle rises during ventricular systole, the two leaflets of the mitral valve come together, thereby 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 during ventricular systole and folding back through the mitral annulus toward the left atrium, multiple fibrous chordae 62, called chordae tendineae, connect the leaflets to the papillary muscles within the left ventricle. Chordae 62 are shown diagrammatically in both the cross-sectional view of the heart in FIG. 1A and in the top view of the mitral valve in FIG. 1B.

[0005] Problems with the proper functioning of the mitral valve are a type of valvular heart disease. Valvular heart disease can also affect other heart valves, including the tricuspid valve. A common form of valvular heart disease is valve leakage, also known as regurgitation, which can occur in various heart valves, including both the mitral and tricuspid valves. Mitral regurgitation occurs when the native mitral valve cannot close properly during ventricular systole and blood flows back from the left ventricle into the left atrium. Mitral regurgitation has different causes, such as leaflet prolapse, incompetent papillary muscles, problems with the chordae tendineae and / or stretching of the mitral valve annulus due to left ventricular dilation. In addition to mitral regurgitation, mitral valve narrowing or mitral stenosis is another example of valvular heart disease. In tricuspid regurgitation, the tricuspid valve does not close properly and blood flows back from the right ventricle into the right atrium. Summary of the Invention [Problem to be solved by the invention]

[0006] Similar to the mitral and tricuspid valves, the aortic valve is susceptible to complications such as aortic stenosis or aortic insufficiency. One method of treating aortic heart disease involves the use of prosthetic valves implanted within the native aortic valve. These prosthetic valves can be implanted using a variety of techniques, including various transcatheter techniques. A transcatheter heart valve (THV) can be crimped onto the end of a flexible and / or steerable catheter and advanced to an implantation site in the heart via a blood vessel connected to the heart, and then expanded to its functional size, for example, by inflating a balloon to which the THV is attached. Alternatively, a self-expanding THV can be held in a radially compressed state within the sheath of a delivery catheter, and the THV can be deployed from the sheath, thereby allowing the THV to expand to its functional state. Such delivery catheters and implantation techniques are generally more developed for implantation or use in the aortic valve, but do not address the unique anatomy and challenges of other valves. [Means for solving the problem]

[0007] This Summary is intended to provide some examples and is not intended to limit the scope of the disclosure in any way. For example, any features included in an example of this Summary are not required by the claims unless the claims explicitly recite those features. Also, the described features can be combined in various ways. Various features and steps as described elsewhere in this disclosure may be included in the examples outlined here.

[0008] Tools and methods are provided for mitral and tricuspid valve replacement, including adapting different types of implants, such as one or more valves (e.g., designed for aortic valve replacement or elsewhere), for use in the mitral and tricuspid positions. One way to adapt these other prosthetic valves in the mitral or tricuspid positions is to deploy the prosthetic valve within an implant, such as an anchor or other docking device / station, that will create a more appropriately shaped implantation site with the native valve annulus. The anchor or other docking device / station herein allows the prosthetic valve to be more securely implanted, and also reduces or eliminates leakage around the valve after implantation.

[0009] One type of implant in the form of an anchor or anchoring device that can be used herein is a docking coil, including a coil anchor or a helical anchor, which provides a circular or cylindrical docking site for a cylindrical prosthetic valve. One type of anchor or anchoring device that can be used herein includes a coiled and / or helical region that provides a circular or cylindrical docking site for a cylindrical prosthetic valve. In this way, possibly an existing valve implant developed for an aortic position can be implanted with such an anchor or anchoring device, possibly with some modification, in another valve position, such as the mitral valve position. Such an anchor or anchoring device can be used in other native valves of the heart, such as the tricuspid valve, to more securely fix the prosthetic valve in those positions as well.

[0010] Described herein are embodiments of a deployment tool and methods for using such a deployment tool to assist in the delivery of an implant in the form of a prosthetic device to one of the native mitral, aortic, tricuspid, or pulmonary valve regions of a human heart. The disclosed deployment tool can be used to deploy an implant in the form of an anchoring device (e.g., a prosthesis docking device, a prosthetic valve docking device, etc.), such as a helical anchoring device or an anchoring device having multiple windings or coils, at an implantation site to provide an underlying support structure onto which a prosthetic heart valve can be implanted. The delivery catheter may include a steerable delivery catheter in some embodiments.

[0011] In an embodiment, a system is disclosed for delivering an implant to a portion of a patient's body. The system may include a delivery catheter including an elongate shaft having an internal lumen for passage of the implant and a distal end portion including a first flexible portion and a second flexible portion positioned distal to the first flexible portion.

[0012] The first flexible portion may include a first tether and a first linear spine positioned circumferentially opposite the first tether, the first flexible portion configured to deflect in a plane when a longitudinal force is applied to the first tether.

[0013] The second flexible portion may include a second tether and a second linear spine positioned non-orthogonal and non-parallel to the first linear spine, the second flexible portion configured to deflect in a direction non-orthogonal and non-parallel to the plane when a longitudinal force is applied to the second tether.

[0014] In an embodiment, a system is disclosed. The system may include a system for delivering an implant to a portion of a patient's body. The system may include a delivery catheter including an elongate shaft having an internal lumen for passage of the implant, a flexible portion having a tether, and a distal end portion including a linear spine positioned at an obtuse angle circumferentially from the tether. The flexible portion may be configured to deflect to form a curve when a longitudinal force is applied to the tether.

[0015] In an embodiment, a system is disclosed for delivering an implant to a portion of a patient's body. The system may include a delivery catheter including an elongate shaft having an internal lumen for passage of the implant and a distal end portion including a first flexible portion and a second flexible portion positioned distal to the first flexible portion.

[0016] The first flexible portion may include a first tether and a first linear spine positioned circumferentially opposite the first tether, the first flexible portion configured to deflect in a first plane when a longitudinal force is applied to the first tether.

[0017] The second flexible portion may include a second tether positioned orthogonally to the first tether, a second linear spine positioned circumferentially opposite the second tether, and a third tether positioned circumferentially opposite the first tether, wherein the second flexible portion is configured to deflect in a second plane orthogonal to the first plane when a longitudinal force is applied to the second tether, and the second flexible portion is configured to deflect in the first plane when a longitudinal force is applied to the third tether.

[0018] In an embodiment, a system is disclosed. The system may include a docking coil configured to dock with an implant within a portion of a patient's body. The system may include an internal lumen through which the docking coil is configured to slide, and a tether extending along at least a portion of the docking coil sleeve and configured to deflect the docking coil sleeve.

[0019] In an embodiment, a system is disclosed that may include a docking coil configured to dock with an implant within a portion of a patient's body and including a leading portion extending to a leading tip and having an orientation.

[0020] The system may include a docking coil sleeve having an internal lumen through which the docking coil is configured to slide and extending to a leading tip and including a leading portion having an orientation different from an orientation of the leading portion of the docking coil, the leading tip of the docking coil sleeve configured to slide relative to the leading tip of the docking coil and deflect the leading tip of the docking coil or the leading tip of the docking coil sleeve radially inward or outward.

[0021] In an embodiment, a method is disclosed. The method may include advancing a delivery catheter to a location within a patient. The delivery catheter may include an elongate shaft having an internal lumen for passage of an implant and a distal end portion including a first flexible portion and a second flexible portion positioned distal to the first flexible portion.

[0022] The first flexible portion may include a first tether and a first linear spine positioned circumferentially opposite the first tether, the first flexible portion configured to deflect in a plane when a longitudinal force is applied to the first tether.

[0023] The second flexible portion includes a second tether and a second linear spine positioned non-orthogonal and non-parallel to the first linear spine, and the second flexible portion is configured to deflect in a direction non-orthogonal and non-parallel to the plane when a longitudinal force is applied to the second tether.

[0024] The method may include deploying the implant from the internal lumen to an implantation site within the patient's body.

[0025] In an embodiment, a method is disclosed. The method may include advancing a delivery catheter to a location within a patient. The delivery catheter may include an elongate shaft having an internal lumen for passage of an implant and a distal end portion including a first flexible portion and a second flexible portion positioned distal to the first flexible portion.

[0026] The first flexible portion may include a first tether and a first linear spine positioned circumferentially opposite the first tether, the first flexible portion configured to deflect in a first plane when a longitudinal force is applied to the first tether.

[0027] The second flexible portion may include a second tether positioned orthogonally to the first tether, a second linear spine positioned circumferentially opposite the second tether, and a third tether positioned circumferentially opposite the first tether, wherein the second flexible portion is configured to deflect in a second plane orthogonal to the first plane when a longitudinal force is applied to the second tether, and the second flexible portion is configured to deflect in the first plane when a longitudinal force is applied to the third tether.

[0028] The method may include deploying the implant from the internal lumen to an implantation site within the patient's body.

[0029] In an embodiment, a method is disclosed that may include deploying a docking coil from a docking coil sleeve to an implantation site within a patient's body, the docking coil configured to dock with an implant within the patient's body, the docking coil sleeve having an internal lumen configured to slide therethrough, the docking coil sleeve including a tether extending along at least a portion of the docking coil sleeve and configured to deflect the docking coil sleeve.

[0030] In an embodiment, a method is disclosed that may include deploying a docking coil from a docking coil sleeve to an implantation site within a patient's body, the docking coil including a leading portion configured to dock with an implant within a portion of the patient's body and extending to a leading tip and having an orientation.

[0031] The docking coil sleeve has an internal lumen through which the docking coil is configured to slide and includes a leading portion extending to the leading tip and having an orientation different from the orientation of the leading portion of the docking coil, the leading tip of the docking coil sleeve configured to slide against the leading tip of the docking coil to deflect the leading tip of the docking coil or the leading tip of the docking coil sleeve radially inward or outward. [Brief description of the drawings]

[0032] The above and other objects, features, and advantages of the present disclosure will become more apparent from the following detailed description taken in conjunction with the accompanying drawings, in which: [Figure 1] Figure 1A shows a schematic cross-sectional view of a human heart, and Figure 1B shows a schematic superior view of the annulus of the mitral valve of the heart. [Diagram 2] FIG. 2 shows a partial perspective view of an exemplary delivery catheter for implanting an implant in the form of an anchoring device into a native valve of the heart using a transseptal technique. [Diagram 3]FIG. 2C shows a cross-sectional view of the anchoring device and an exemplary prosthetic heart valve implanted at the native valve of the heart. [Figure 4] FIG. 4 shows a side view of the delivery catheter. [Diagram 5] Figure 5A shows a cross-sectional view of a portion of a delivery catheter, Figure 5B shows a cross-sectional view of the delivery catheter along line 5B-5B, and Figure 5C shows a cross-sectional view of the delivery catheter along line 5C-5C. [Figure 6] FIG. 6 shows a side cross-sectional view of the spine. [Figure 7] Figure 7A shows a top view of the distal end portion of the catheter. Figure 7B shows an end view of the catheter shown in Figure 7A. Figure 7C shows a top view of the distal end portion of the catheter deflected from the position shown in Figure 7A. Figure 7D shows an end view of the catheter in the position shown in Figure 7C. [Figure 8] Figure 8A shows an end view of the catheter. Figure 8B shows a top view of the catheter shown in Figure 8A. Figure 8C shows a top view of the catheter shown in Figure 8B with the distal end portion of the catheter deflected. Figure 8D shows an end view of the catheter shown in Figure 8C. Figure 8E shows a side view of the catheter shown in Figure 8D. [Figure 9] Figure 9A shows a cross-sectional view of a portion of a delivery catheter, Figure 9B shows a cross-sectional view of the delivery catheter along line 9B-9B, and Figure 9C shows a cross-sectional view of the delivery catheter along line 9C-9C. [Figure 10] Figure 10A shows a cross-sectional view of a portion of a delivery catheter, Figure 10B shows a cross-sectional view of the delivery catheter along line 10B-10B, and Figure 10C shows a cross-sectional view of the delivery catheter along line 10C-10C. [Figure 11] Figure 11A is a cutaway lateral view of a portion of a patient's heart showing an exemplary delivery catheter advanced through the fossa ovalis into the left atrium in an exemplary manner, and Figure 11B illustrates the delivery catheter of Figure 11A advanced into the left atrium of the patient's heart in the position shown in Figure 11A, with the delivery device shown in a view taken along line 11B-11B of Figure 11A. [Figure 12]Figure 12A shows the delivery device of Figure 11A in one position. Figure 12B shows the delivery device of Figure 11A in the position of Figure 12A, where the delivery device is shown from a perspective along line 12B-12B of Figure 12A. [Figure 13] Figure 13A shows a side perspective view of the docking coil, and Figure 13B shows a top view of the docking coil shown in Figure 13A. [Figure 14] Figure 14A shows a side view of the docking coil sheath, Figure 14B shows a side view of the docking coil sheath shown in Figure 14A with a portion shown in cross section, and Figure 14C shows a cross-sectional view of the docking coil sheath shown in Figure 14B taken along line 14C-14C. [Figure 15] Figure 15A shows a side view of a docking coil sheath, partially shown in cross-section, and Figure 15B shows a cross-sectional view of the docking coil sheath shown in Figure 15A taken along line 15B-15B. [Figure 16] Figure 16A shows a side view of a docking coil sheath, partially shown in cross-section, and Figure 16B shows a cross-sectional view of the docking coil sheath shown in Figure 16A taken along line 16B-16B. [Figure 17] Figure 17A shows a cross-sectional view of a portion of a docking coil sheath, Figure 17B shows a top schematic view of a docking coil sheath extending around a mitral valve, and Figure 17C shows a side cross-sectional view of a mitral valve with a docking coil and docking coil sheath extending around the mitral valve. [Figure 18] Figure 18A shows a side perspective view of the docking coil, and Figure 18B shows a top view of the docking coil shown in Figure 18A. [Figure 19] Figure 19A shows a side view of the leading portion of the docking coil and the leading portion of the docking coil sheath, Figure 19B shows a cross-sectional view of the docking coil positioned within the docking coil sheath, and Figure 19C shows a cross-sectional view of the docking coil positioned within the docking coil sheath and deflecting the docking coil sheath. [Figure 20] FIG. 20 shows a cross-sectional view of the docking coil sheath. [Figure 21]Figure 21A shows a cross-sectional view of a docking coil sheath, and Figure 21B shows a cross-sectional view of a docking coil extending into the docking coil sheath. [Figure 22] Figure 22A shows a schematic of a docking coil extending into a docking coil sheath, and Figure 22B shows a schematic of a docking coil deflecting the docking coil sheath. [Figure 23] Figure 23A shows a side view of a docking coil sheath, Figure 23B shows a cross-sectional view of a docking coil within the docking coil sheath, and Figure 23C shows a cross-sectional view of a docking coil within the docking coil sheath. [Figure 24A] FIG. 24A is a lateral cutaway view of the left side of a patient's heart showing an anchoring device delivered around the chordae tendineae and valve leaflets within the left ventricle of the patient's heart. [Figure 24B] FIG. 24B shows the anchoring device of FIG. 24A further wrapped around the chordae tendineae and valve leaflets in the left ventricle of the patient's heart as it is being delivered by the delivery catheter of FIG. 24A. [Figure 24C] FIG. 24C shows the anchoring device of FIG. 24A further wrapped around the chordae tendineae and valve leaflets in the left ventricle of the patient's heart as it is being delivered by the delivery catheter of FIG. 24A. [Figure 24D] FIG. 24D is a view looking down into the patient's left atrium showing the delivery catheter after the anchoring device has been wrapped around the chordae tendineae and valve leaflets within the left ventricle of the patient's heart. [Figure 24E] FIG. 24E illustrates the delivery catheter within the left atrium of the patient's heart with the delivery catheter retracted to deliver a portion of the anchoring device into the left atrium of the patient's heart. [Figure 24F] FIG. 8L illustrates the delivery catheter within the left atrium of the patient's heart where the delivery catheter has been retracted to deliver an additional portion of the anchoring device into the left atrium of the patient's heart. [Figure 24G]FIG. 24G illustrates a delivery catheter in the left atrium of the patient's heart with the anchoring device exposed and shown firmly connected to a pusher in the left atrium of the patient's heart. [Fig. 24H] FIG. 24H illustrates the delivery catheter in the left atrium of the patient's heart, with the anchor device completely removed from the delivery device and loosely and releasably attached to the pusher by sutures. [Figure 24I] FIG. 24I is a cut-away view of a patient's heart showing an exemplary embodiment of a prosthetic heart valve being delivered to the patient's mitral valve by an exemplary embodiment of a heart valve delivery device. [Figure 24J] FIG. 24J shows the heart valve of FIG. 24I being further delivered to the patient's mitral valve by a heart valve delivery device. [Figure 24K] FIG. 24K shows the heart valve of FIG. 24I opened by inflation of a balloon to expand the heart valve and attach it to the patient's mitral valve. [Figure 24L] FIG. 24L shows the heart valve of FIG. 24I attached to the mitral valve of a patient's heart and secured by the anchoring device of FIG. 9I. [Figure 24M] FIG. 24M is an elevational view of the mitral valve of the left ventricle showing the prosthetic heart valve of FIG. 24I attached to the mitral valve of a patient's heart from a perspective along line 24M-24M of FIG. 24L. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0033] The following description and the accompanying figures, which describe and show specific examples, are made to demonstrate in a non-limiting manner some possible configurations of systems, devices, instruments, components, methods, etc. that can be used in various aspects and features of the present disclosure. As an example, various systems, devices / instruments, components, methods, etc. are described herein that can be related to mitral valve procedures. However, the specific examples provided are not intended to be limiting, for example, the systems, devices / instruments, components, methods, etc. can be adapted for use in other valves outside of the mitral valve (e.g., in the tricuspid valve).

[0034] Described herein are embodiments of a deployment tool intended to facilitate implantation of an implant in the form of a prosthetic device (e.g., a prosthetic valve) at one of the native mitral, aortic, tricuspid, or pulmonary valve regions of a human heart, and embodiments of a method for using such a deployment tool. The prosthetic device or valve may be an expandable transcatheter heart valve ("THV") (e.g., a balloon-expandable THV, a self-expandable THV, and / or a mechanically expandable THV). The deployment tool may be used to deploy an anchoring device (sometimes referred to as a docking device, docking station, or similar terminology) that provides a more stable docking site for securing the prosthetic device or valve (e.g., a THV) to the native valve region. The anchoring device may include a docking coil in some embodiments. These deployment tools can be used to more precisely position such anchoring devices (e.g., prosthetic organ anchoring devices, prosthetic valve anchoring devices, etc.) so that the anchoring devices and any prostheses (e.g., prosthetic devices or prosthetic heart valves) secured to them can function properly after implantation.

[0035] FIG. 2 illustrates a delivery device 2 for placing an implant in the form of an anchoring device 14 into the native mitral valve annulus 50 using a transseptal technique. The same or similar delivery device 2 can be used to deliver the anchoring device 14 at the tricuspid valve without leaving the right atrium and crossing the septum into the left atrium. The delivery device 2 includes a sheath catheter that includes an outer sheath or guide sheath 20. The delivery device 2 includes a delivery catheter 100. The guide sheath 20 has a shaft shaped as an elongated hollow tube through which the delivery catheter 100 and various other components (e.g., implants such as anchoring devices, prosthetic heart valves, etc.) can pass and thus be introduced into the patient's heart 5. The guide sheath 20 is steerable so that the guide sheath 20 can bend at various angles required for the guide sheath 20 to pass through the heart 5 and enter the left atrium 51. The sheath 20 may include a steerable guide sheath that includes an internal lumen for the delivery catheter to pass through. The steerable guide sheath may be configured to deflect a portion of the elongate shaft of the delivery catheter 100 when the elongate shaft is disposed within the lumen of the steerable guide sheath. When positioned within the guide sheath 20, the delivery catheter 100 has a relatively straight or rectilinear shape (as compared to a curved shape, described in more detail below), e.g., the delivery catheter 100 is retained within the guide sheath 20 in a configuration or shape that corresponds to the configuration or shape of the guide sheath 20.

[0036] Like the guide sheath 20, the delivery catheter 100 has an elongated shaft in the form of a long hollow tube. However, the delivery catheter 100 has a smaller diameter than the sheath 20 so that it can slide axially within the sheath 20. On the other hand, the delivery catheter 100 is large enough to accommodate and deploy an implant, such as an anchoring device, such as a docking coil.

[0037] The elongate shaft of the delivery catheter 100 may have a distal end portion 102. The distal end portion 102 may be bent into a configuration that allows for more precise placement of an anchoring device, such as a docking coil, and may allow the distal end portion 102 to be held in such a configuration. For example, the distal end portion 102 may be bent into a curved shape to aid in pushing or pushing from the anchoring device on the ventricular side of the mitral valve 50, so that the lower coil (e.g., functional coil and / or surrounding coil) of the anchoring device 14 may be properly positioned below the native valve annulus. The distal end portion 102 may also be bent into a curved shape so that the upper coil(s) of the anchoring device (e.g., stabilizing coil / winding or upper coil) may be precisely deployed on the atrial side of the native valve annulus. For example, the distal end portion 102 may have a curved shape for mounting the upper coil and a curved shape for mounting the lower coil. In other embodiments, the distal end portion 102 can have one configuration for mounting a lower coil and another configuration for mounting an upper coil.

[0038] 3 shows an anchoring device in the form of a docking coil positioned around a mitral valve, with a prosthetic valve, such as a transcatheter heart valve (THV) 60, docked with the anchoring device. The anchoring device 14 can be implanted with one or more upper coils / windings (e.g., upper coils 10a, 10b) positioned above the annulus of a native valve (e.g., mitral valve 50 or tricuspid valve), i.e., on the atrial side, and the lower coils 12a, 12b positioned below the annulus of the native valve, i.e., on the ventricular side. In this configuration, the mitral valve leaflets 53, 54 can be captured between the upper coils 10a, 10b and the lower coils 12a, 12b. When implanted, the various anchoring devices herein can provide a solid support structure to secure the prosthetic valve in place and avoid movement due to heart movement.

[0039] 2, in a method of deployment, when accessing the mitral valve using a transseptal delivery method, the guide sheath 20 may be inserted through the femoral vein, through the inferior vena cava 57, and into the right atrium 56. Alternatively, the guide sheath 20 may be inserted through the jugular or subclavian veins, or other upper vasculature site, passed through the superior vena cava, and advanced into the right atrium. The atrial septum 55 is then pierced (e.g., at the fossa ovalis) and the sheath 20 advanced into the left atrium 51, as can be seen in FIG. 2. (In a tricuspid valve procedure, there is no need to pierce or cross the septum 55.)

[0040] For a mitral valve procedure, with the sheath 20 in place within the left atrium 51, the delivery catheter 100 is advanced from the distal end 21 of the sheath 20 such that the distal end portion 102 of the delivery catheter 100 is also within the left atrium 51. At this position, the distal end portion 102 of the delivery catheter 100 can be driven into a curved shape to place the anchoring device 14 at the annulus of the mitral valve 50. The anchoring device 14 can then be advanced through the delivery catheter 100 and placed at the mitral valve 50. The anchoring device 14 can be attached to a pusher that advances or pushes the anchoring device 14 through the delivery catheter 100 for implantation. The pusher can be a wire or tube having sufficient strength and physical properties to push the anchoring device 14 through the delivery catheter 100. In some embodiments, the pusher can be formed from or can include a spring or coil, a tube extruder, a braided tube, or a laser cut hypotube, among other structures. In some embodiments, the pusher can have a coating thereon and / or therein, for example, an internal lumen coated with PTFE to allow a thread (e.g., a suture) to be actuated atraumatically through the coated lumen. As described above, in some embodiments, the pusher can actuate the distal end portion 102 such that the atrial coil of the anchoring device 14 can be released in the left atrium while the ventricular coil of the anchoring device 14 is maintained or held in place in the left ventricle after pushing and properly positioning the ventricular coil of the anchoring device 14 in the left ventricle.

[0041] After the anchoring device 14 is placed, the delivery catheter 100 can be removed by straightening or reducing the curvature of the distal end portion 102 to allow the delivery catheter 100 to return through the guide sheath 20. Then, with the delivery catheter 100 removed, a prosthetic valve, for example a prosthetic transcatheter heart valve (THV) 60, can be passed through the guide sheath 20, for example, as shown in FIG. 3, and secured within the anchoring device 14. Once the THV 60 is secured within the anchoring device 14, the guide sheath 20 along with any other delivery devices for the THV 60 can be removed from the patient's body, and the patient's septum 55 and right femoral vein opening can be closed. In other embodiments, the THV 60 can be delivered after the anchoring device 14 is implanted, using a different sheath or a different delivery device all separately. For example, a guidewire can be introduced through the guide sheath 20, or the guide sheath 20 can be removed and a guidewire can be advanced through the same access point, through the native mitral valve, and into the left ventricle using a separate delivery catheter. However, in this embodiment, although the anchoring device is implanted transseptally, it is not limited to transseptal implantation, nor is the delivery of the THV 60 limited to transseptal delivery (or, more generally, via the same access point as the delivery of the anchoring device). In still other embodiments, following transseptal delivery of the anchoring device 14, any of a variety of other access points can be used to subsequently implant the THV 60, for example, transapically, transatrially, or via the femoral artery.

[0042] 4 illustrates an example of a delivery catheter 100 that may be utilized in accordance with examples herein. The delivery catheter 100 may include an elongate shaft 104 with a distal end portion 102 that terminates at a distal tip 106. The distal tip 106 may include an opening through which an implant may pass and be deployed from the delivery catheter 100. The elongate shaft 104 may include a proximal portion 108 that may be coupled to a handle 110.

[0043] The handle 110 may be configured for a user to grasp and manipulate to control the elongate shaft 104. For example, the handle 110 may be configured for a user to grasp as the elongate shaft 104 is driven distally and advanced into the vasculature of a patient's body. The handle 110 may also be configured for a user to grasp and rotationally drive the elongate shaft 104 when positioned within the patient's vasculature. Rotation of the handle 110 may rotationally drive the position of the distal tip 106 of the elongate shaft 104, thereby positioning the distal tip 106 in a desired configuration.

[0044] The handle 110 may further include a deflection mechanism 112 that may be utilized to deflect all or a portion of the elongate shaft 104, including one or more portions of the distal end portion 102. The deflection mechanism 112 may engage a proximal portion of one or more tethers, which may be configured, for example, to have a longitudinal force applied to the respective tether by the deflection mechanism 112 to deflect a portion of the elongate shaft 104.

[0045] Deflection mechanism 112 may include one or more actuators 114, 116 that may be configured to be actuated by a user to move the respective tethers, for example. Actuators 114, 116 may include, for example, control knobs as shown in FIG. 4, or may have other forms depending on the embodiment. Actuators 114, 116 may be configured to actuate the tethers within the tether channels by applying a longitudinal force to the respective tethers within the tether channels. The longitudinal force may result in deflection of all or a portion of distal end portion 102 of elongate shaft 104. In other embodiments, other forms of deflection mechanisms may be utilized.

[0046] The delivery catheter 100 may further include various irrigation ports 120, 122, 124 that may provide irrigation fluid to one or more lumens of the delivery catheter 100. The delivery catheter 100 may further include a hub assembly 118 that may include a suture lock assembly 121. The hub assembly 118 may be configured to control features of a system for deploying the anchoring device, which may include control of a pusher shaft 126 and a docking coil sleeve. A handle 128 of the docking coil sleeve may be utilized to control the position of the docking coil sleeve relative to the pusher shaft 126. The hub assembly 118 may be coupled to the handle 110 via a connector 130.

[0047] Features of the delivery catheter 100 and delivery system that may be utilized in the embodiments of the present specification may be disclosed in International Patent Application No. PCT / US2020 / 036577, filed June 8, 2020, entitled "Systems, Devices, and Methods for treating Heart Valves," and published as WO / 2020 / 247907, and U.S. Patent Publication Nos. 2018 / 0318079, 2018 / 0263764, and 2018 / 0177594, all of which are incorporated by reference in their entireties.

[0048] 5A shows a cross-sectional view of the elongate shaft 104. The elongate shaft 104 may include an outer surface 132 that may be configured to slide inside another catheter, such as the sheath 20 of the steerable guide sheath shown in FIG. 2. The elongate shaft 104 may be configured to bend, such as to conform to the shape of the sheath 20 of the sheath catheter or other structure through which the elongate shaft 104 may pass. The elongate shaft 104 may have a cylindrical shape, or may have another shape as desired in some embodiments.

[0049] The elongate shaft 104 may include a sheath that may be configured for an implant, such as an anchoring device, such as a docking coil, to pass through, along with other components of an implant delivery system. A docking coil sleeve is configured to pass through the elongate shaft 104. The elongate shaft 104 may include an internal lumen 134 that extends proximally from a distal tip 106 of the elongate shaft 104 to a proximal end of the elongate shaft 104. The internal lumen 134 may be configured for an implant, such as an anchoring device, such as a docking coil, to pass through, and may further allow for the docking coil sleeve to pass through. In embodiments, other components, such as a catheter, or other devices may pass through the internal lumen 134. The elongate shaft 104 may include an inner surface 136 that may face the internal lumen 134.

[0050] The elongate shaft 104 may include a wall 138 that may face the interior lumen 134. The wall 138 may be made of a flexible material that may allow all or a portion of the elongate shaft 104 to deflect in a desired manner.

[0051] The distal end portion 102 of the elongate shaft 104 may include one or more portions. The distal end portion 102 may include, for example, a first flexible portion 140 and a second flexible portion 142 positioned distally of the first flexible portion 140.

[0052] The first flexible portion 140 may include a first tether 144 that may extend into a tether lumen 146 to a distal end of the first tether 144. The distal end may be coupled to a fixation ring 148 or other fixed point within the elongate shaft 104. The first flexible portion 140 may further include a first spine 150 that extends along the elongate shaft 104. In embodiments, the first spine 150 may include a linear spine that extends along the longitudinal axis of the elongate shaft 104.

[0053] 5B shows a cross-sectional view of elongate shaft 104 along line 5B-5B of FIG. 5A, illustrating a cross-sectional view of first flexible portion 140. First spine 150 may be positioned circumferentially opposite first tether 144 and first tether lumen 146. First spine 150 may be positioned, for example, at a linear angle indicated by line 152 from first tether 144. In this manner, a longitudinal force applied to first tether 144 will deflect first flexible portion 140 in a plane along line 152. First tether 144 may be positioned across inner lumen 134 from first spine 150.

[0054] First spine 150 and first tether 144 may each be embedded within the body of elongate shaft 104. First spine 150 may comprise a material having a greater stiffness and higher durometer than adjacent portions of wall 138. The adjacent portions of wall 138 may be circumferentially adjacent to first spine 150.

[0055] The first flexible portion 140 can include a second tether 154 and a second tether lumen 156 extending therethrough. The second tether 154 can be positioned orthogonal to the first tether 144 and the first spine 150. The second tether 154 can be orthogonal from the first tether 144 in a clockwise direction when facing the proximal direction of the elongate shaft 104, as shown in FIG. 5B, for example.

[0056] 5A, first flexible portion 140 may be positioned between second flexible portion 142 and portion 158 of elongate shaft 104 positioned proximate first flexible portion 140. Portion 158 may include a wall 160 having a greater stiffness and higher durometer than first flexible portion 140, thus allowing first flexible portion 140 to deflect relative to portion 158 when a longitudinal force is applied to first tether 144.

[0057] The second flexible portion 142 may be disposed distal to the first flexible portion 140 and proximal to the distal tip 106 of the elongate shaft 104. In embodiments, the second flexible portion 142 may include the distal tip 106.

[0058] Figure 5C shows a cross-sectional view of second flexible portion 142. The second flexible portion may include a second tether 154 that may extend distally from the first flexible portion 140 shown in Figure 5B. A second tether lumen 156 may extend distally from the first flexible portion 140, and the second tether 154 may extend within the second tether lumen 156. The second tether lumen 156 may have a distal end that may be coupled to a fixation device, such as a fixation ring 162, as shown in Figure 5A.

[0059] The second tether 154 may be positioned axially in line within the second flexible portion 142, which is in a position within the first flexible portion 140. Thus, as shown in Figures 5B and 5C, the second tether 154 may be at the same circumferential position. The second tether 154 may be positioned orthogonal to the first tether 144 and the first spine 150.

[0060] However, the second flexible portion 142 may include a second spine 164, such as a second linear spine positioned offset from the circumferential position of the first linear spine 150 shown in FIG. 5B. The second linear spine 164 may be positioned non-orthogonal and non-parallel to the first linear spine 150, as shown in the relative positions between the first linear spine 150 and the second linear spine 164 in FIGS. 5B and 5C. The second linear spine 164 may be positioned at an obtuse angle 165 relative to the first linear spine 150, for example, as shown in the relative positions in FIGS. 5B and 5C. Such an obtuse angle 165 may include, in embodiments, a range between 91 degrees and 179 degrees. In embodiments, the second linear spine 164 may be positioned at an acute angle relative to the first linear spine 150.

[0061] Second linear spine 164 and second tether 154 may each be embedded in the body of elongate shaft 104. Second tether 154 in some embodiments may include a pull tether configured to be retracted proximally to deflect second flexible portion 142. First tether 144 in some embodiments may include a pull tether configured to be retracted proximally to deflect first flexible portion 140.

[0062] The second linear spine 164 may have a proximal portion that is coupled to a distal portion of the first linear spine 150, the second linear spine 164 being offset from the circumferential position of the first linear spine 150. FIG. 6 shows a representative cross-sectional view of a spine of a delivery catheter, for example. The proximal spine 167, which may correspond to the first linear spine 150, may have a distal portion that is coupled to a fixation device, such as a fixation ring 148, and may have a proximal portion that is coupled to a fixation device, such as a fixation ring 169. The distal portion of the proximal spine may be coupled to a proximal portion of the distal spine 171 via the fixation ring 148 or another coupling manner. The distal spine 171 may correspond to the second linear spine 164. The distal spine 171 may have a distal portion that is coupled to the fixation ring 162. Thus, the spines may comprise a single body in embodiments, the spines being coupled together. The spines shown in FIG. 6 are positioned parallel to one another. However, the spines 150, 164 shown in Figures 5B and 5C are positioned non-parallel and non-orthogonal to one another.

[0063] Referring again to FIG. 5C, the second linear spine 164 may be positioned non-parallel from the second tether 154. Additionally, the second linear spine 164 may be positioned non-orthogonally from the second tether 154. The second linear spine 164 may be positioned at an obtuse angle in a circumferential direction from the second tether 154, which may include a range of 91 degrees to 179 degrees, in embodiments. The second linear spine 164 may be positioned on the opposite side of the wall 138 from the second tether 154, and may be positioned in a circumferential orientation with respect to the second tether 154 that is between the circumferentially opposite position and the circumferential position of the first tether 144 shown in FIG. 5B. The second linear spine 164 may be positioned at an acute angle with respect to the first tether 144, as shown in FIGS. 5B and 5C. Thus, the second linear spine 164 may be positioned closer to the second tether 154 in a clockwise direction when facing proximally than in a counterclockwise direction.

[0064] The relative orientation of the second tether 154 and the second linear spine 164 shown in FIG. 5C may allow the second flexible portion 142 to deflect in a direction that is non-orthogonal and non-parallel to the plane (represented by line 152) in which the first flexible portion 140 may deflect when a longitudinal force is applied to the second tether 154. The non-parallel position of the second linear spine 164 and the second tether 154 may, for example, allow the second flexible portion 142 to deflect in a direction defined by line 166 in FIG. 5C. The line 166 may, for example, extend between the second linear spine 164 and the second tether 154 and is non-parallel and non-orthogonal to the line 152 (which may represent the plane of deflection of the first flexible portion 140), as shown in FIG. 5C.

[0065] The direction in which second flexible portion 142 is configured to deflect may be obtuse relative to the direction of deflection of first flexible portion 140. Thus, first flexible portion 140 may be configured to deflect upward in the plane, as shown in FIG 5B, and second flexible portion 142 may be configured to deflect downward and out of the plane due to the orientation of second linear spine 164 and second tether 154 shown in FIG 5C.

[0066] 7A-8E show an exemplary deflection of the distal end portion 102, including, for example, a first flexible portion 140 and a second flexible portion 142. The location of the first tether 144 is shown in dashed lines for reference.

[0067] 7A, first flexible portion 140 and second flexible portion 142 are shown extending linearly from guide sheath 20. First flexible portion 140 may be configured to deflect in a plane, with first tether 144 and first spine 150 extending therein, represented by line 152 in FIG. 5B. The direction of deflection may be toward first tether 144 as first tether 144 retracts in the proximal longitudinal direction. FIG. 7B, for example, shows arrow 163 representing the plane along line 152 and the direction of deflection.

[0068] 7C illustrates the first flexible portion 140 deflected in the direction of arrow 163 in FIG. 7B, for example. The first tether 144 may be retracted to deflect the first flexible portion 140. The first flexible portion 140 may be deflected in a plane along line 152 shown in FIGS. 7B and 7D. Thus, the second flexible portion 142 may be deflected to be positioned at an angle relative to the proximal portion 158 of the elongate shaft 104. The first flexible portion 140 may be configured to deflect up to an angle of 90 degrees in the plane defined by line 152, or up to an angle of 180 degrees in some embodiments, as desired.

[0069] 8A-8E illustrate an exemplary deflection of the second flexible portion 142 and rotation of the elongate shaft 104. As shown in FIG. 8A, the elongate shaft 104 may be rotated relative to the guide sheath 20, and such rotation may be in a counterclockwise or clockwise direction when facing proximally, although counterclockwise rotation is shown in FIG. 8A. The rotation may be 90 degrees to orthogonally position the first tether 144 from the position shown in FIG. 7B. In embodiments, other degrees of rotation may be utilized.

[0070] Thus, first tether 144 may be positioned upward in Figure 8A, and first flexible portion 140 may be configured to deflect in upward direction 168 in the plane defined by line 152. Figure 8B shows the resulting orientation of first tether 144 in the position shown in Figure 8A.

[0071] Figures 8C and 8D show example directions of deflection of second flexible portion 142 when first flexible portion 140 is in the orientation shown in Figure 8B. Second flexible portion 142 may deflect in a direction that is non-orthogonal and non-parallel to the plane defined by line 152 along which first flexible portion 140 is configured to deflect. Second tether 154 may be retracted to deflect second flexible portion 142. The relative orientation of the deflection directions is shown in Figure 8D.

[0072] As shown in Figures 8C and 8D, the second flexible portion 142 may be configured to deflect to form a proximally extending curve when a longitudinal force is applied to the second tether 154. As such, the degree of deflection 170 of the second portion 142 may be greater than 90 degrees in some embodiments, and may be greater than 180 degrees in some embodiments, as shown in Figure 8C. The curve of the second flexible portion 142 may position the distal tip 106 of the second flexible portion 142 at an angle other than the angle shown in Figure 8B, or may be orthogonal to the orientation shown in Figure 8B. In some embodiments, other angles may be formed by the deflection of the second flexible portion 142.

[0073] Figure 8E shows a side view of elongate shaft 104 from a perspective rotated 90 degrees from the perspective of Figure 8D. The curve of second flexible portion 142 is shown to extend to a plane 175 that is non-orthogonal and non-parallel to the plane defined by line 152 shown in Figure 8D in which first flexible portion 140 is configured to deflect.

[0074] In the side view of Figure 8E, the distal tip 106 is shown to extend in a plane that is parallel to and offset from the plane in which the first flexible portion 140 extends. The distance between the planes may be defined by a height 172 marked in Figures 8D and 8E. The distal tip 106 may be positioned below a portion of the elongate shaft 104 and oriented transverse to the direction of the distal tip 106 shown in Figure 8B. Thus, the distal tip 106 may be oriented in a different direction and may be at a different height than the height shown in Figure 8B.

[0075] The deflection of the second flexible portion 142 may form a height 172 between a proximal portion of the second flexible portion 142 and a distal portion of the second flexible portion 142, which may include the distal tip 106. The height 172 may further be between the distal tip 106 and the first flexible portion 140, or the proximal portion 158 of the elongate shaft 104, or the guide sheath 20, as shown in FIG. 8E. The height 172 may allow the implant to be deployed from the distal tip 106 at a lower height relative to the proximal portion of the second flexible portion 142. In this manner, during a procedure, the height 172 may be utilized to position the distal tip 106 in a ventricular direction relative to the proximal portion of the second flexible portion 142, and thus, in an embodiment, may position the distal tip 106 in an intraventricular direction that may be proximal to the commissures of the mitral valve. Thus, first flexible portion 140 may be positioned in the atrium and height 172 may be toward the ventricle. Additionally, the curve of second flexible portion 142 may be planar relative to the mitral valve plane such that the implant can be deployed from distal tip 106 in the mitral valve plane.

[0076] The curve of the second flexible portion 142 as shown in Figures 8C-8E may be counterclockwise relative to the mitral valve annulus when the second flexible portion 142 is viewed in a direction from the atrium to the ventricle. Such a curvature direction may allow an anchoring device, such as a docking coil, to be deployed with a counterclockwise curvature relative to the mitral valve annulus when the second flexible portion 142 is viewed in a direction from the atrium to the ventricle. In embodiments, another curvature direction (e.g., clockwise when the second flexible portion 142 is viewed in a direction from the atrium to the ventricle) may be utilized.

[0077] The configuration of elongate shaft 104 shown in Figures 8C-8E may be utilized to deploy the anchoring device at the mitral valve or elsewhere within the patient's body, as desired. The configuration of elongate shaft 104 shown in Figures 8C-8E may correspond to the positions of elongate shaft 104 shown in Figures 12A and 12B, for example.

[0078] 9A-9C illustrate an embodiment of the elongate shaft 104 in which the orientation of the second tether 154 relative to the second spine 164 differs from the orientation shown in FIG. 5C. In the embodiment of FIG. 9A-9C, the second tether 154 is positioned circumferentially opposite the second linear spine 164. In this manner, the second flexible portion 142 is configured to deflect in a direction 176 about a plane defined by a line 174. The second tether 154 may be positioned at a linear angle relative to the second linear spine 164.

[0079] The second linear spine 164 is positioned non-orthogonal and non-parallel to the first linear spine 150 shown in Figure 9B. The second flexible portion 142 is configured to deflect in a direction 176 that is non-orthogonal and non-parallel to a plane defined by the line 152 along which the first flexible portion 140 is configured to deflect when a longitudinal force is applied to the second tether 154. The direction 176 may be obliquity relative to the deflection direction of the first flexible portion 140.

[0080] The second tether 154 may be positioned at an obtuse angle relative to the position of the first tether 144, as shown in Figures 9B and 9C. Further, in embodiments, the second linear spine 164 may be positioned at an obtuse angle relative to the position of the first linear spine 150. The second linear spine 164 may be positioned at an acute angle relative to the first tether 144.

[0081] Deflection of the second flexible portion 142 may result in a configuration similar to that shown in Figures 8C-8E, where the curve extends proximally and a height 172 is formed between the distal tip 106 and the proximal portion of the second flexible portion 142 and the first flexible portion 140.

[0082] 10A-10C illustrate an embodiment in which the elongate shaft 104 includes a third tether 178. The third tether 178 may extend along the elongate shaft 104 and may extend to the second flexible portion 142. For example, as shown in the cross-sectional view of FIG. 10B, the first flexible portion 140 may include a first tether 144 positioned circumferentially opposite the first linear spine 150. The first flexible portion 140 may be configured to deflect in a plane defined by a line 152 when a longitudinal force is applied to the first tether 144. The second tether 154 may extend along the first flexible portion 140 and may extend orthogonally to the first tether 144 and the first linear spine 150.

[0083] Third tether 178 may extend through first flexible portion 140 at a location circumferentially opposite first tether 144 and at a location that may be perpendicular to the location of second tether 154. First flexible portion 140 may be configured to deflect in a plane defined by line 152. In an embodiment, third tether 178 may extend through first spine 150 or may otherwise be positioned to allow third tether 178 to pass through first flexible portion 140.

[0084] 10C illustrates an example of the second flexible portion 142 showing the position of the second linear spine 164 relative to the second tether 154. The second linear spine 164 may be positioned circumferentially opposite the second tether 154, or may be positioned orthogonal to the position of the first linear spine 150 and the first tether 144, as shown in FIG. 10B. The second tether 154 may be positioned orthogonal to the first tether 144. As such, the second flexible portion 142 may be configured to deflect in a plane defined by a line 180 when a longitudinal force is applied to the second tether 154. The plane may be orthogonal to the plane in which the first flexible portion 140 deflects in the plane defined by the line 152.

[0085] The third tether 178 may be utilized to deflect the second flexible portion 142 in a direction away from the deflection direction of the first flexible portion 140. As such, the third tether 178 may extend within the second flexible portion 142 and may be positioned circumferentially opposite the first tether 144 shown in FIG. 10B. As such, the third tether 178 may deflect the second flexible portion 142 in a direction away from the deflection direction of the first flexible portion 140 when a longitudinal force is applied to the third tether 178. The third tether 178 may be configured to allow the second flexible portion 142 to deflect further along the plane defined by the line 152 in an opposite direction to the first flexible portion 140. The third tether 178 of an example embodiment may include a pull tether configured to retract proximally to deflect the second flexible portion 142.

[0086] In an embodiment, second flexible portion 142 may include a third linear spine 182 that may be circumferentially opposed to third tether 178 and positioned orthogonally from second tether 154. Third linear spine 182 may be positioned in-line with first tether 144 shown in FIG. 10B. In an embodiment, third linear spine 182 may be omitted.

[0087] In operation, the first flexible portion 140 may be configured to bend in a manner similar to that shown in FIGS. 7A-7D. The second flexible portion 142 may be configured to form a curve in a plane perpendicular to the plane of the first flexible portion 140 when the second tether 154 is retracted. The curve may extend proximally. The third tether 178 may be retracted such that the second flexible portion 142 produces a height, resulting in a configuration similar to that shown in FIGS. 8C-8E. The third tether 178 may allow a user to control the height of the resulting curve based on the amount of tension placed on the third tether 178.

[0088] Thus, second flexible portion 142 may be configured to deflect in a blunt direction relative to the deflection direction of first flexible portion 140 based on a longitudinal force applied to both second tether 154 and third tether 178. Second flexible portion 142 may extend in a plane that is non-orthogonal and non-parallel to the plane defined by line 152 when a longitudinal force is applied to both second tether 154 and third tether 178.

[0089] Examples of the delivery catheter, elongate shaft, and distal end portion of the elongate shaft may be utilized to deploy an anchoring device, which may include a docking coil in some embodiments. Features disclosed herein may comprise a system for delivering an implant to a portion of a patient's body. Various sheath and delivery catheter designs may be used to effectively deploy the anchoring device at the implantation site. For example, the delivery catheter may be shaped and / or positioned to face the commissure A3P3 so that the coil anchor deployed from the catheter can more easily enter the left ventricle and surround the chordae tendineae 62 during advancement. However, while various exemplary embodiments of the present disclosure described below are configured to position the distal opening of the delivery catheter at the commissure A3P3 of the mitral valve, in other embodiments, the delivery catheter may instead approach the mitral surface to face the commissure A1P1 and advance the anchoring device through the commissure A1P1. Additionally, the catheter can be bent clockwise or counterclockwise to approach either the commissure of the mitral valve or the desired commissure of another native valve, and the anchor device can be implanted or inserted in a right- or counterclockwise direction (e.g., the coil / windings of the anchor device can be rotated in a clockwise or counterclockwise direction depending on how the anchor device is implanted).

[0090] 11A-12B illustrate a method of positioning, for example, using an example elongate shaft of a delivery catheter as disclosed herein. Positioning may include positioning the distal tip 106 of the delivery catheter 100 at the commissure of the mitral valve and may include positioning the curve of the distal end portion 102 in a plane with the mitral valve annulus. FIGs. 11A-12B illustrate a method of positioning the delivery catheter 100 to deliver an implant, such as an anchoring device, relative to the native valve. The anchoring device may include a docking device, such as a docking coil, as disclosed herein.

[0091] The delivery catheter 100 may be advanced to a location within the patient. The delivery catheter 100 may include any embodiment of a delivery catheter disclosed herein. The delivery catheter 100 may deliver and implant an implant in the form of an anchoring device (which may be the same as or similar to other anchoring devices described herein) at the patient's native valve (e.g., at the patient's native mitral valve 50 using a transseptal technique).

[0092] FIG. 11A is a cutaway view of the left atrium of a patient's heart illustrating a sheath catheter sheath 20 (e.g., a guide sheath or transseptal sheath) advanced through the atrial septum into the left atrium, as may occur at the fossa ovalis (FO), and a delivery catheter 100 extending from the sheath 20.

[0093] Figure 11B shows the guide sheath 20 and delivery catheter 100 in the position shown in Figure 11A in a view looking down on the mitral valve 50 from the left atrium 51 (i.e., from a perspective along line 11B-11B in Figure 11A). With reference to Figure 11A, the sheath 20 may enter the left atrium such that the sheath is substantially parallel to the plane of the mitral valve 50. The guide sheath 20 may take any suitable form, such as, for example, any of the forms described in this application.

[0094] In some embodiments, the sheath 20 can be actuated or steered as a steerable guide sheath such that the sheath 20 can be positioned or bent until it forms an angle (e.g., a 30 degree angle or about a 30 degree angle) with respect to the septum and / or FO wall. In some embodiments, the angular orientation (e.g., a 30 degree angular orientation) can be adjusted or controlled by rotating or further actuating the sheath 20 and adjusted to better control the orientation at which the delivery catheter 100 enters the left atrium. In other embodiments, the deflection angle of the sheath 20 with respect to the septum and / or FO can be either more than 30 degrees or less than 30 degrees depending on the circumstances, and in some applications can be oriented or bent to be 90 degrees with respect to the septum and / or FO. In certain embodiments, the deflection angle of the sheath can move from about 0 degrees to about 90 degrees, e.g., from about 5 degrees to about 80 degrees, e.g., from about 10 degrees to about 70 degrees, e.g., from about 15 degrees to about 60 degrees, e.g., from about 20 degrees to about 50 degrees, e.g., from about 25 degrees to about 40 degrees, e.g., from about 27 degrees to about 33 degrees, etc.

[0095] 12A-12B, after the outer or guide sheath 20 is positioned through the septum and / or FO to the desired location, the delivery catheter 100 is extended out of the sheath 20. The delivery catheter 100 may be driven distally from the sheath 20 such that the delivery catheter 100, so configured, extends from the guide sheath 20 in a straight configuration. In an embodiment, the delivery catheter 100 may extend in a straight configuration for some distance within the atrium, although the distal end portion 102 of the delivery catheter 100 may begin to deflect. The delivery catheter 100 may be positioned in the desired location by extension of the delivery catheter 100 from the guide sheath 20 and by deflection of the guide sheath 20 to the desired amount. For example, the guide sheath 20 may be deflected to point toward the ventricle to orient the delivery catheter 100 in such direction.

[0096] With the delivery catheter 100 extending into the left atrium 51, the first flexible portion 140 and / or the second flexible portion 142 may be deflected to position the distal tip 106 of the elongate shaft at a desired position relative to the mitral valve annulus.

[0097] In an embodiment, a method may include inserting a delivery catheter 100 into the left atrium 51, with the first flexible portion 140 configured to deflect upward in a direction away from the mitral valve annulus (e.g., toward the atrial direction). Such an orientation may be shown in FIG. 8A, with a first tether 144 configured to deflect the first flexible portion 140 in a direction away from the mitral valve annulus. However, the first flexible portion 140 may not deflect in such a direction, and the second flexible portion 142 may instead be deflected with the second flexible portion 142 extending in a downward curve in a ventricular direction toward the mitral valve, as shown in FIGS. 8C-8E. FIGS. 8D and 8E may extend downward in a ventricular direction, for example, and the height 172 shown in FIGS. 8D and 8E may extend in a ventricular direction toward the mitral valve.

[0098] The resulting configuration of the distal end portion 102 may extend to the commissures of the mitral valve, which may include the A3P3 commissures, for example, as shown in FIG. 12B. The elongate shaft 104 may be positioned within the atrium and the second flexible portion 142 may be biased to the commissures of the patient's mitral valve. The curve of the second flexible portion 142 may extend in the plane of the mitral valve annulus for deployment of the anchor device at the commissures of the mitral valve.

[0099] The distal tip 106 may be positioned below the commissures and may extend into the ventricle in embodiments, if desired. The delivery catheter 100 may be deflected downward until the circular / curved planar portion of the distal end portion 102 approaches the plane of the mitral valve 50, which is typically about 30-40 mm below the FO wall. However, in some circumstances, the plane of the mitral valve may be less than 30 mm below the FO, or more than 30 mm below the FO. In certain embodiments, the delivery catheter 100 is configured to extend 60 mm or less from the outer sheath, e.g., 50 mm or less, 45 mm or less, 40 mm or less, 35 mm or less, 30 mm or less, 25 mm or less, 20 mm or less, etc. In some embodiments, the maximum extension of the delivery catheter 100 from the outer sheath is about 20 mm to about 60 mm, e.g., about 25 mm to about 50 mm, about 30 mm to about 40 mm, etc.

[0100] The lower curved portion of the shape of the distal end portion 102 may drop down to or near the level of the annulus, and the lower curved portion may be parallel or nearly parallel to the plane of the annulus (e.g., flat or nearly flat), or the lower curved portion may be at a slight upward angle relative to the plane of the annulus.

[0101] In embodiments, additional deflection of the catheter 100 may be utilized. For example, upon entering the left atrium 51, the first flexible portion 140 may be configured such that the first flexible portion deflects in a plane parallel to and offset from the plane of the mitral valve annulus, as shown in FIG. 7B. In such a configuration, the second flexible portion 142 may be partially or fully deflected to extend in a ventricular direction toward the mitral valve. In this manner, the distal tip 106 may extend in a ventricular direction downward toward the left ventricle.

[0102] With the second flexible portion 142 partially or fully deflected, the first flexible portion 140 may be deflected in a plane parallel to the plane of the mitral valve annulus, similar to the deflected configuration shown in FIG. 7C. However, the second flexible portion 142 in such a configuration may remain extending in a ventricular direction with the distal tip 106 positioned proximate to a commissure of the mitral valve. The deflection of the first flexible portion 140 and / or the second flexible portion 142 may be adjusted as desired to position the distal tip 106 at a desired commissure of the mitral valve, for example, the A3P3 commissure. Additionally, rotation of the delivery catheter 100 may be used to position the distal tip 106 at a desired location relative to the A3P3 commissure.

[0103] In a method step, an anchoring device, such as a docking coil, may be extended partially out of the distal tip 106 so as to be positioned within the ventricle and outside the mitral valve leaflets. Such a procedure may cause the anchoring device to hook onto a portion of the mitral valve leaflets to maintain the position of the distal tip 106 of the delivery catheter 100. In an embodiment, the step of partially extending the docking coil may be omitted.

[0104] With the distal tip 106 in a desired position relative to the A3P3 commissure, deflection of the first flexible portion 140 back toward a straight configuration and the delivery catheter 100 may be rotated in the direction shown in FIG. 8A resulting in the second flexible portion 142 being in the orientation shown in FIGS. 8C-8E. In this manner, the resulting second flexible portion 142 may be configured to deploy the anchor device in the mitral valve plane as shown in FIGS. 12A and 12B. In such a configuration, the curve of the second flexible portion 142 extending toward the ventricle may help prevent the distal tip 106 from loosening from its position at the A3P3 commissure when the delivery catheter 100 is rotated in the direction shown in FIG. 8A.

[0105] Thus, the curvature of the second flexible portion 142 configured to extend toward the ventricle includes an improvement over a configuration in which the first and second flexible portions deflect in orthogonal planes. In a configuration in which the first and second flexible portions deflect in orthogonal planes, a torque may be exerted on the second flexible portion when the delivery catheter is rotated in the direction shown in FIG. 8A. Such a torque may undesirably cause the distal tip to loosen from its position at the A3P3 commissure.

[0106] The resulting configurations shown in Figures 12A and 12B may result whether or not the elongate shaft 104 configurations shown in the various embodiments of Figures 5A-10C are utilized.

[0107] With the delivery catheter 100 in the configuration shown in Figures 12A and 12B, an anchoring device may be deployed at the implantation site. The anchoring device may have a variety of forms, examples of which are shown in International Patent Application No. PCT / US2020 / 036577, filed June 8, 2020, entitled "Systems, Devices, and Methods for treating Heart Valves," published as WO / 2020 / 247907, which is incorporated herein by reference in its entirety. An implant in the form of an anchoring device may be deployed from the internal lumen of the delivery catheter 100 to an implantation site within the patient's body. In embodiments where the implant comprises a docking coil, the docking coil may be deployed around the leaflets of the patient's mitral valve.

[0108] 13A and 13B illustrate examples of anchoring devices that may be utilized in accordance with embodiments herein. For example, the anchoring device may include a docking coil 200 that may be configured to dock with an implant within a portion of a patient's body.

[0109] The docking coil 200 may include one or more windings that may be utilized for implantation and / or stabilization within a patient's body. The docking coil 200 may include, for example, a surrounding or leading winding 202 that may extend to a distal or leading tip 204 of the docking coil 200. The surrounding or leading winding 202 may be configured to surround the native structures of the patient's heart during deployment, for example, the native valve leaflets and chordae tendineae that are surrounded during implantation of the docking coil 200.

[0110] A proximal portion of the surrounding or leading winding 202 may be coupled to one or more functional windings 206. The functional windings 206 may be formed into a coil having windings 206 stacked on top of one another along a central axis of the docking coil 200. The functional windings 206 may include one or more lower windings 206a and one or more upper windings 206b. The lower windings 206a in the embodiment may be configured to be positioned on the ventricular side of the mitral valve, and the upper windings 206b in the embodiment may be configured to be positioned on the atrial side of the mitral valve. Thus, the mitral valve in the embodiment may be configured to be positioned between the functional windings 206 of the docking coil 200.

[0111] In an embodiment, both the lower winding 206a and the upper winding 206b may be positioned on the ventricular side of the mitral valve and configured to surround the mitral valve leaflets and other natural structures such as chordae tendineae.

[0112] In an embodiment, the transition curve 208 may be coupled to a proximal portion of the functional winding 206 and may extend to a stabilizing winding 210, which may have a larger diameter than the functional winding 206 and may be configured to be positioned on the atrial side of the mitral valve. The transition curve 208 may extend in the axial dimension and may be configured to transition between the functional winding 206 and the stabilizing winding 210 through the commissures of the mitral valve.

[0113] 13B illustrates a top view of the docking coil 200 shown in FIG. 13A. In embodiments, the configuration of the docking coil 200 may vary as desired. Features of docking coils that may be utilized in embodiments herein are disclosed in International Patent Application No. PCT / US2020 / 036577, filed June 8, 2020, entitled "Systems, Devices, and Methods for Treating Heart Valves," and published as WO / 2020 / 247907, which is incorporated herein by reference in its entirety.

[0114] The docking coil 200 may be configured to be deployed at the mitral valve with a docking coil sleeve 212, as shown in FIG. 14A , extending over the docking coil 200. The docking coil 200 may be positioned within a lumen of the docking coil sleeve 212. The docking coil 200 may be deployed within the docking coil sleeve 212 by being wound around the leaflets of the mitral valve and other natural structures including the chordae tendineae. Windings of the docking coil 200 wrapped around structures of the mitral valve are shown, for example, in FIGS. 24A-24C, and stabilizing windings 210 deployed within the atrium are shown, for example, in FIGS. 24D-24H.

[0115] The docking coil 200 may be configured to have an outer surface configured to create a frictional lock to the mitral valve structure such that upon contact with the mitral valve structure, the outer surface is configured to provide friction to lock the docking coil 200 in place.

[0116] The docking coil sleeve 212 is configured to be positioned between the docking coil 200 and mitral valve structures, such as the mitral valve leaflets, thereby extending over the docking coil 200 to reduce friction between the docking coil 200 and the mitral valve structures during deployment. With the docking coil 200 and docking coil sleeve 212 in place, the docking coil sleeve 212 may be retracted relative to the docking coil 200, leaving the docking coil 200 in place on the mitral valve leaflets.

[0117] 14A illustrates a side view of one embodiment of a docking coil sleeve 212 that may be utilized in accordance with embodiments herein. The docking coil sleeve 212 may include a distal tip 214 and a proximal end 216, and a length extending from the distal tip 214 to the proximal end 216. The docking coil sleeve 212 may include an outer surface 218 that may be configured to be lubricious to reduce friction between the docking coil sleeve 212 and mitral valve structure as the sleeve extends around the mitral valve structure during deployment.

[0118] 14B illustrates a partial cross-sectional view of the docking coil sleeve 212 shown in FIG. The docking coil sleeve 212 may include an internal lumen 220 within which the docking coil 200 may be configured to slide. The internal lumen 220 may face opposite the lubricious outer surface 218. The internal lumen 220 may extend distally to the distal tip 214. A wall 222 of the docking coil sleeve 212 may extend around the internal lumen 220.

[0119] The distal tip 214 may have an opening through which the docking coil 200 passes for deployment from the docking coil sleeve 212 .

[0120] The docking coil sleeve 212, in an embodiment, may be configured to be flexible to contour around the native mitral valve leaflets having the docking coil 200 positioned within the internal lumen 220. The docking coil sleeve 212 may thus form a coil as it extends around the native mitral valve leaflets to configure the coil shape of the docking coil 200 positioned within the internal lumen 220.

[0121] A problem may arise when the leading winding 202 of the docking coil 200 within the docking coil sleeve 212 is wound around the native mitral valve leaflets. A potential complication is that if the diameter of the leading winding 202, shown in FIG. 13A, is too large, the leading tip 204 of the docking coil 200 or the distal tip 214 of the docking coil sleeve 212 may undesirably contact surfaces within the patient's heart, which may include walls within the left ventricle or other structures such as chordae tendineae. Thus, it may be desirable to utilize a docking coil sleeve 212 that may be deflectable to allow guidance of the docking coil sleeve 212 around the mitral valve leaflets.

[0122] In embodiments herein, the docking coil sleeve 212 may include a tether 224 that extends along at least a portion of the docking coil sleeve 212 and may be configured to deflect the docking coil sleeve 212. The tether 224 may be configured to deflect the distal tip 214 of the docking coil sleeve 212.

[0123] The tether 224 may extend along a tether lumen 226 that may extend along all or a portion of the docking coil sleeve 212. The tether 224 may be configured to be positioned at a distal portion 228 of the docking coil sleeve 212 and may be configured to be positioned along an inner curve of the distal portion 228 of the docking coil sleeve 212 when the docking coil sleeve 212 is wrapped around the native structure of the mitral valve. In embodiments, the tether 224 may be positioned elsewhere as desired. The tether 224 may have a distal end that may be coupled to a fixation device, such as a fixation ring 230, that may be positioned at the distal tip 214 of the docking coil sleeve 212 or at another location as desired.

[0124] The tether 224 may be configured to be retracted proximally to bias the docking coil sleeve 212 in a direction towards the tether 224. The tether 224 may comprise a pull tether in some embodiments, if desired.

[0125] In an embodiment, the tether 224 may include a proximal portion 229 that may extend outside of the docking coil sleeve 212 for engagement and retraction during use.

[0126] FIG. 14C shows a cross-sectional view of the docking coil sleeve 212 taken along line 14C-14C of FIG. 14B.

[0127] Variations in the configuration of the docking coil sleeve 212 may be provided. For example, Figures 15A and 15B show an embodiment in which the docking coil sleeve 240 includes a spine 242 extending along at least a portion of the docking coil sleeve 240. The spine 242 may be positioned circumferentially opposite the tether 246. The spine 242 may be configured to oppose deflection of the docking coil sleeve 240 in a direction toward the tether 246. In this manner, the spine 242 may provide a resilient force that deflects the docking coil sleeve 240 in the opposite direction upon release of the tether 246.

[0128] The docking coil sleeve 240 may further include a braid 248 that may be positioned within the wall 250. Thus, the braid 248 may include braided layers. The braid 248 may extend around the interior lumen 244. An example braid 248 may be positioned at a distal end portion of the docking coil sleeve 240.

[0129] As shown in FIGURE 15A, the embodiment braid 248 may have a looser braid configuration at a distal portion of the braid 248 relative to a proximal portion of the braid 248. As such, the braid 248 may be configured to have a greater deflection near the distal end 252 of the docking coil sleeve 240 than at a proximal portion of the docking coil sleeve 240. The braid 248 may have an increased flexibility in a direction toward the distal tip of the docking coil sleeve 240. As such, the docking coil sleeve 240 may have a greater deflection at the distal end 252 than at the proximal portion of the docking coil sleeve 240 when a deflection force is applied by the tether 246. FIGURE 15B shows a cross-sectional view along line 15B-15B of FIGURE 15A.

[0130] 16A and 16B show an example of a docking coil sleeve 260 including a first retaining ring 262 and a second retaining ring 264 positioned in a spaced apart relationship from one another. A spine 266 may extend between the first retaining ring 262 and the second retaining ring 264 and may operate in a manner similar to the spine 242 shown in FIGS. 15A and 15B. The space between the retaining rings 262, 264 may define an area for the docking coil sleeve 260 to deflect due to retraction of the tether 268. FIG. 16B shows a cross-sectional view along line 16B-16B of FIG. 16A.

[0131] 17A-17C illustrate an exemplary operation of a docking coil sleeve including a tether for deflection as disclosed in embodiments herein. FIG. 17A illustrates, for example, a docking coil 200 within an internal lumen 220 of a docking coil sleeve 212, for example as shown in FIG. 14 . A distal tip or leading tip 204 of the docking coil 200 may be positioned a distance 267 from a distal tip 214 of the docking coil sleeve 212. Thus, the distal tip 214 of the docking coil sleeve 212 may overhang the distal tip 204 of the docking coil 200. The space within the lumen 220 between the distal tip or leading tip 204 of the docking coil 200 and the distal tip 214 of the docking coil sleeve 212 may enhance flexibility of the distal tip 214 of the docking coil sleeve 212 when a longitudinal force is applied to the tether 224.

[0132] A longitudinal force applied to the tether 224 may deflect the distal tip 214 in the direction of the arrow 269 shown in Figure 17A. In a configuration in which the docking coil sleeve 212 forms a coil, the direction of deflection indicated by the arrow 269 may be radially inward.

[0133] FIG. 17B illustrates a top schematic view of the operation of the docking coil sleeve 212, with the upper windings of the docking coil sleeve 212 visible and the distal tip 214 of the docking coil sleeve 212 shown to include a leading portion of the docking coil sleeve 212, extending around the leaflets 271, 273 of the mitral valve. The docking coil sleeve 212 may be deflectable via the operation of the tether 224, and may be deflectable radially inwardly as represented by the arrows 269 shown in FIG. 17B. Additionally, the distal tip 214 may be deflectable radially outwardly via release of the tether 224. Arrows 270 may represent deflection due to release of the tether 224. In an embodiment, for example, as shown in FIGS. 15A-16B, the spines 242, 266 may deflect the distal tip 214 radially outwardly upon release of the tether 224. 15A-15B, braid 248 may be used to position the deflection at distal tip 214. In embodiments, for example, in Figures 16A-16B, a deflection portion between retaining rings 262, 264 may be used to position the deflection at distal tip 214. Various combinations of features may be used in embodiments.

[0134] 17C shows a side view of the docking coil sleeve 212 extending around the mitral valve leaflets 271, 273 with the distal tip 214 deflectable due to the action of the tether 224. The docking coil sleeve 212 may be deflectable radially inward or outward utilizing the tether 224. The docking coil sleeve 212 may be deflected with the tether 224. The tether 224 may be retracted to deflect the docking coil sleeve 212.

[0135] The windings of the docking coil 200 within the docking coil sleeve 212 may extend in a ventricular direction as shown in Figure 17C. In embodiments, other forms of enclosure may be utilized.

[0136] The docking coil 200 within the docking coil sleeve 212 may surround the mitral valve leaflets when deployed from a delivery catheter as may be disclosed herein. The docking coil sleeve 212 may be deflected with a tether 224 during the surrounding of the mitral valve leaflets.

[0137] With the docking coil sleeve 212 and docking coil 200 in the desired position, the docking coil 200 may be deployed from the docking coil sleeve 212 to the implantation site by retracting the docking coil sleeve 212 proximally relative to the docking coil 200. Thus, the docking coil 200 may remain in place on the mitral valve leaflets.

[0138] 4 may engage a proximal portion of tether 224 to allow tether 224 to retract and deflect docking coil sleeve 212. In embodiments, other forms of deflection mechanisms may be utilized as desired.

[0139] The deflectable distal tip of the docking coil sleeve may advantageously allow for a reduction in the likelihood of undesired contact with structures of the native heart valve, which may include undesired contact with the ventricular wall or chordae tendineae. Additionally, the deflectable distal tip of the docking coil sleeve may allow for enhanced control of the docking coil sleeve to surround desired native structures, such as the mitral valve leaflets and chordae tendineae.

[0140] 18A-22C illustrate examples where the leading portion of the docking coil sleeve may have an orientation that is different from the orientation of the leading portion of the docking coil. The leading tip of the docking coil sleeve may be configured to slide relative to the leading tip of the docking coil to deflect the leading tip of the docking coil or the leading tip of the docking coil sleeve radially inward or outward.

[0141] Figure 18A is an example of a docking coil 280 that may be utilized in accordance with embodiments herein. The docking coil 280 may include a leading portion 282 in the form of a leading winding that may have a smaller diameter than the leading winding 202 shown in Figure 13A. For example, the leading portion 282 may have a diameter that matches the diameter of the functional winding 284 and therefore may have a smaller radius of curvature than the leading winding 202 shown in Figure 13A.

[0142] The leading portion 282 may be oriented (eg, FIG. 18A) and extend to a leading tip 285 of the docking coil 280 .

[0143] The configuration of the stabilization winding 286 and the transfer curve 288 may be similar to the configurations of the stabilization winding 210 and the transfer curve 208, respectively, shown in FIG. 13A.

[0144] FIG. 18B shows a top view of the docking coil 280 shown in FIG. 18A.

[0145] Figure 19A shows a close-up view of the leading portion 282 of the docking coil 280 relative to the leading portion 290 of the docking coil sleeve 292. As shown in Figure 19A, the leading portion 282 of the docking coil 280 may have a curved orientation with a defined radius of curvature.

[0146] The leading portion 290 of the docking coil sleeve 292 may extend to a leading tip 298 of the docking coil sleeve 292. The leading portion 290 may have an orientation that is different from the orientation of the leading portion 282 of the docking coil 280. As shown in FIG 19A, for example, the leading portion 290 of the docking coil sleeve 292 may have a straight configuration. In other embodiments, other orientations may be utilized, including curved orientations having different radii of curvature of the docking coil 280, among other orientations.

[0147] 19B, the docking coil 280 may be positioned within an interior lumen 294 of the docking coil sleeve 292. The interior lumen 294 of the docking coil sleeve 292 may be configured for the docking coil 280 to slide within. The leading tip 285 of the docking coil 280 may be positioned a distance 296 from the leading tip 298 of the docking coil sleeve 292. The leading tip 298 of the docking coil sleeve 292 extends in a direction marked by line 300 in FIG. 19B.

[0148] The docking coil 280 may be slidable within an internal lumen 294 of the docking coil sleeve 292, and may be slidable distally and proximally within the docking coil sleeve 292. Sliding the docking coil 280 within the internal lumen 294 of the docking coil sleeve 292 may vary the distance 296 of the leading tip 285 of the docking coil 280 from the leading tip 298 of the docking coil sleeve 292.

[0149] A change in the distance 296 of the leading tip 285 of the docking coil 280 from the leading tip 298 of the docking coil sleeve 292 may cause the leading tip 298 of the docking coil sleeve 292 to deflect. For example, as shown in FIGURE 19C, as the docking coil 280 is advanced distally relative to the leading tip 298 of the docking coil sleeve 292, the distance 301 between the leading tip 285 of the docking coil 280 and the leading tip 298 of the docking coil sleeve 292 is reduced from the distance 296 shown in FIGURE 19B.

[0150] Due to the radius of curvature of the leading portion 282 of the docking coil 280, the docking coil sleeve 292 may conform to and deflect accordingly to the curvature of the leading portion 282. Figure 19C, for example, illustrates a change in deflection angle 302 of the leading tip 298 of the docking coil sleeve 292 from the orientation represented by line 300 shown in Figure 19B. As such, the leading tip 298 of the docking coil sleeve 292 may deflect from the position shown in Figure 19B due to the sliding movement of the docking coil 280 within the inner lumen 294.

[0151] The docking coil 280 may be retracted to allow the docking coil sleeve 292 to return to the configuration shown in Figure 19B. For example, the docking coil sleeve 292 may be biased to return to the configuration shown in Figure 19B upon retraction of the docking coil 280.

[0152] The relative positions of the leading tip 298 of the docking coil sleeve 292 and the leading tip 285 of the docking coil 280 may be varied to allow the leading tip 298 of the docking coil sleeve 292 to deflect during deployment of the docking coil 280. For example, the distance between the tips 285, 298 may be varied to induce deflection during wrapping of the mitral valve leaflets.

[0153] 22A and 22B, for example, illustrate such operation. The docking coil 280 is shown extending into the docking coil sleeve 292, with the leading tip 285 of the docking coil 280 being a distance from the leading tip 298 of the docking coil sleeve 292 in FIG. 22A. The leading portion 290 of the docking coil sleeve 292 may have a preset radius of curvature, which may be greater than the preset radius of curvature of the leading portion 282 of the docking coil 280. Additionally, the orientation of the leading portion 282 of the docking coil 280 may be configured to form a diameter smaller than the diameter of the leading portion 290 of the docking coil sleeve 292, as shown in FIG. 22A.

[0154] Sliding the leading tip 285 of the docking coil 280 distally relative to the leading tip 298 of the docking coil sleeve 292 may deflect the leading tip 298 of the docking coil sleeve 292 radially inward, for example, as shown in FIG. 22B. Additionally, sliding the leading tip 285 of the docking coil 280 proximally relative to the leading tip 298 of the docking coil sleeve 292 may deflect the leading tip 298 of the docking coil sleeve 292 radially outward. Such action returns the docking coil sleeve 292 to the position shown in FIG. 22A, for example. Once the docking coil 280 is in the desired position, the docking coil sleeve 292 may be fully retracted, leaving the docking coil 280 in place over the mitral valve leaflets.

[0155] 19A, the docking coil sleeve 292 may have a straight configuration. In an embodiment, the docking coil sleeve 292 may have a preset curvature that can be deflected by different curvatures of the docking coil 280.

[0156] 20, for example, illustrates an example of a docking coil sleeve 304 having a leading portion 306 with a preset curvature. The leading portion 306 may include a curved portion 308 and a straight portion 310 distal to the curved portion 308. A docking coil may pass through an internal lumen 312 to deflect the leading tip and change the deflection angle 314 of the leading tip.

[0157] Figure 21A shows an example of a docking coil sleeve 316 with a leading portion 318 with a preset curvature. A leading tip 320 of the docking coil sleeve 316 retains the curvature of the leading portion 318. Figure 21B shows a docking coil 322 passing through an interior lumen 324 of the docking coil sleeve 316 to deflect the leading tip 320 and change the deflection angle 326 of the leading tip 320.

[0158] Deflection of the docking coil sleeve may allow the docking coil sleeve to be deflected during deployment of the docking coil. Such deflection may help to avoid undesired contact with native structures to encircle structures such as the mitral valve leaflets and chordae tendineae. Deflection may thus produce results similar to those represented by arrows 269 and 270 in FIG. 17C.

[0159] Once the docking coil sleeve 292 and docking coil 280 are in a desired position, for example around the mitral valve leaflets, the docking coil sleeve 292 may be retracted relative to the docking coil 280. The docking coil 280 may remain in a position to be deployed over the mitral valve leaflets with the docking coil sleeve 292 removed from the patient's ventricle.

[0160] The relative position of the docking coil sleeve 292 and the docking coil 280 may be controlled using a control mechanism that may control the relative position of the leading tips 298, 285 and the change in the distance between the leading tips 298, 285. For example, a control mechanism may be coupled to a proximal portion of the docking coil sleeve 292 and the docking coil 280 to control and change the distance between the leading tips 298, 285.

[0161] In embodiments, the docking coil sleeve 292 may include a spine as shown in FIGS. 15A and 15B, or a braid as shown in FIGS. 15A and 15B, or a spine extending between the retaining rings as shown in FIGS. 16A and 16B. The spine may extend along the leading portion of the docking coil sleeve, for example. The braid may be located in the leading portion of the docking coil sleeve. Such features may bias the docking coil sleeve 292 back to a preset orientation of the docking coil sleeve 292 as the docking coil 280 is retracted proximally. Various combinations of features may be provided as desired.

[0162] In an embodiment, the docking coil may comprise a leading portion of a docking coil and docking coil sleeve combination that surrounds the mitral valve leaflets. FIGS. 23A-23C, for example, illustrate such an example, where the docking coil sleeve 330 may have a preset curvature, for example, as shown in FIG. 23A. The docking coil 332 may be positioned within an inner lumen 334 of the docking coil sleeve 330, for example, as shown in FIG. 23B. The docking coil 332 may include one or more notches 336 on the docking coil 332, which may allow the leading tip 333 of the docking coil 332 to deflect on the docking coil sleeve 330 that extends over the docking coil 332. The one or more notches 336 may be positioned on an inner curve of the docking coil 332.

[0163] The orientation of the leading portion 329 of the docking coil 332 may be configured to form a diameter that is greater than a diameter of the leading portion 331 of the docking coil sleeve 330. The leading portion 331 of the docking coil sleeve 330 may have a preset radius of curvature that may be less than the preset radius of curvature of the leading portion 329 of the docking coil 332. As such, sliding the leading tip 333 of the docking coil 332 distally relative to the leading tip 335 of the docking coil sleeve 330 may deflect the leading tip 333 of the docking coil 332 radially inward.

[0164] FIG. 23C, for example, shows the docking coil sleeve 330 advanced distally to deflect the docking coil 332 and change the deflection angle of the docking coil 332.

[0165] 18A-23C may allow the docking coil sleeve and / or docking coil to deflect during deployment, thus avoiding undesirable contact with native structures or allowing for better encirclement of native structures such as the mitral valve leaflets or chordae tendineae.

[0166] 24A-24M show the process involving further deployment of an anchoring device in the form of a docking coil and further embedding of an artificial implant into the anchoring device. The process may continue from the catheter device in the position shown in FIG. 12B.

[0167] 24A illustrates the delivery catheter 100 deploying a docking coil sleeve 212 through the commissure A3P3 and around the chordae tendineae 62 and native valve leaflets in the left ventricle 52 of the patient's heart. The anchoring device or leading portion, or surrounding coil / windings of the anchoring device, is led out of the distal opening of the delivery catheter 100 and begins to assume its shape set or shape memory configuration in the direction of the delivery catheter 100. The anchoring device may be positioned within the docking coil sleeve 212. The anchoring device may comprise a docking coil that passes through the interior lumen of the catheter 100.

[0168] 24B, the docking coil sleeve 212 may be further deployed from the delivery catheter 100 such that the docking coil sleeve 212 wraps around the chordae tendineae 62 in a position substantially parallel to the plane of the mitral valve 50. The docking coil sleeve 212 may be deflected according to embodiments herein during the encirclement procedure.

[0169] 24C, the docking coil sleeve 212 is placed around the chordae tendineae 62 to loosely position the anchoring device on the ventricular side of the mitral valve to retain the heart valve. In the illustrated embodiment, the docking coil sleeve 212 is placed in the left ventricle 52 such that the functional coil 340 of the anchoring device and the docking coil sleeve 212 are tightly wrapped around the chordae tendineae and / or the native valve leaflets. The lower end winding / coil, or the surrounding winding / coil in the example may extend outward somewhat due to its larger radius of curvature. In some examples, the anchoring device may include fewer than three coils or more than three coils that are placed around the chordae tendineae and / or the valve leaflets.

[0170] When the anchoring device is in the desired position, the docking coil sleeve may be retracted to leave the anchoring device in place over the mitral valve leaflets.

[0171] 24D shows the delivery catheter 100 in position within the left atrium 51 after the coils of the anchoring device have been placed around the chordae tendineae 62 and the native valve leaflets (as shown in FIG. 24C ). In this position, the distal tip 106 of the delivery catheter 100 is substantially parallel to the plane of the mitral valve 50 and is located at or near the commissure A3P3 of the mitral valve 50 (e.g., extending slightly into or through the commissure A3P3, such as 1-5 mm or less).

[0172] 24E, the delivery catheter may be translated or retracted axially along the anchoring device in direction X into the outer sheath 20. Translation or retraction of the delivery catheter unsheathes and releases the portion of the anchoring device located on the atrial side of the native valve (e.g., in the atrium). For example, this may unsheathe and release any functional coils and / or any upper portions of the upper coils located on the atrial side of the native valve (if present). In one exemplary embodiment, the anchoring device does not move or does not substantially move as the delivery catheter translates, such as by using a pusher to hold the anchoring device in place as the delivery catheter is retracted and / or to inhibit or prevent retraction of the anchoring device.

[0173] Features of a pusher that may be utilized in the embodiments herein are disclosed in International Patent Application No. PCT / US2020 / 036577, filed June 8, 2020, entitled "Systems, Devices, and Methods for Treating Heart Valves," and published as WO / 2020 / 247907, which is incorporated by reference in its entirety.

[0174] 24F, in the illustrated example, translation or retraction of the delivery catheter can also unplug / release any top end coils / windings (e.g., larger diameter stabilizing coils / windings) of the anchoring device or docking coil 200 from the delivery catheter. As a result of the unplug / release, the atrial side of the anchoring device or upper coils (e.g., stabilizing coils with a larger diameter or larger radius of curvature) extends from the delivery catheter 100 and begins to assume its pre-set or relaxed shape-set / shape-memory shape. In an embodiment, the anchoring device may also include an upwardly extending or connecting portion that extends upward from the bend Z and can extend and / or bridge between the top end stabilizing coils / windings and other coils / windings of the anchoring device (e.g., functional coils / windings). In some embodiments, the anchoring device can have only one upper coil on the atrial side of the native valve. In some embodiments, the anchoring device can include multiple upper coils on the atrial side of the native valve.

[0175] 24G, the delivery catheter 100 continues back into the outer sheath or guide sheath 20, causing the top of the anchoring device to be released from inside the delivery catheter. The anchoring device is tightly connected to the pusher 950 by an attachment means such as a suture / line 901 (other attachment or connection means may also be used, as desired). A top end coil / winding or stabilizing coil / winding is shown to be placed along the atrial wall to temporarily and / or loosely hold the position or height of the anchoring device relative to the mitral valve 50.

[0176] 24H, the anchoring device is completely removed from the lumen of the delivery catheter 100 and the slack is removed with a suture / thread 901 that is removably attached to the anchoring device, e.g., the suture / thread 901 can be looped through a hole at the end of the anchoring device. To remove the anchoring device from the delivery catheter 100, the suture 901 is removed from the anchoring device. However, before the suture 901 is removed, the position of the anchoring device can be checked. If the position of the anchoring device or docking coil 200 is incorrect, the anchoring device can be pulled back into the delivery catheter by a pusher 950 (e.g., a pusher rod, pusher wire, pusher tube, etc.) and redeployed.

[0177] 24I, after the delivery catheter 100 and the outer sheath 20 are detached from the anchoring device, a heart valve delivery device / catheter 902 can be used to deliver a heart valve 903 to the mitral valve 50. The heart valve delivery device 902 may utilize one or more components of the delivery catheter 100 and / or the outer or guiding sheath 20, or the delivery device 902 may be independent of the delivery catheter 100 and the outer or guiding sheath. In the illustrated embodiment, the heart valve delivery device 902 enters the left atrium 51 using a transseptal approach. In an embodiment, the heart valve delivery catheter 902 may pass through the outer sheath 20. The heart valve delivery catheter 902 may deploy a prosthetic heart valve to dock with the anchoring device in the form of a docking coil.

[0178] Implant features that may be utilized in the embodiments herein for docking with an anchor device are disclosed in International Patent Application No. PCT / US2020 / 036577, filed June 8, 2020, entitled "Systems, Devices, and Methods for Treating Heart Valves," and published as WO / 2020 / 247907, which is incorporated by reference in its entirety.

[0179] 24J, a heart valve delivery device / catheter 902 is moved through the mitral valve 50 such that the heart valve 903 is disposed between the leaflets of the mitral valve and the anchor device. The heart valve 903 can be guided along a guidewire 904 to a deployment position.

[0180] Referring to Fig. 24K, after the heart valve 903 is placed in the desired position, the optional balloon is inflated to expand the heart valve 903 to its expanded deployed size. That is, the optional balloon is inflated so that the heart valve 903 engages the leaflets of the mitral valve 50 and forces the ventricle outward to the increased size to secure the leaflets between the heart valve 903 and the anchoring device. The outward force of the heart valve 903 and the inward force of the coil can pinch the self-tissue to hold the heart valve 903 and the coil to the leaflets. In some embodiments, the self-expanding heart valve may be held in a radially compressed state within the sheath of the heart valve delivery device 902 and the heart valve may be deployed from the sheath, which expands the heart valve to its expanded state. In some embodiments, a mechanically expandable heart valve is used or a partially mechanically expandable heart valve is used (e.g., a valve that can be expanded by a combination of self-expansion and mechanical expansion).

[0181] 24L, after the heart valve 903 has been moved to its expanded state, the heart valve delivery device 902 and the wire 904 are removed from the patient's heart. Additionally, the guide sheath 20 may be removed from the patient's heart as well. The heart valve 903 is in a functional state and replaces the functions performed by the mitral valve 50 of the patient's heart.

[0182] FIG. 24M shows the heart valve 903 from an elevational view in the left ventricle 52. In FIG. 24M, the heart valve 903 is in an expanded and functional state. In the illustrated embodiment, the heart valve 903 includes three valve members 905a-c (e.g., leaflets) configured to move between an open position and a closed position. In alternative embodiments, the heart valve 903 can have four or more valve members configured to move between an open position and a closed position, e.g., two or more valve members, three or more valve members, four or more valve members, etc. In the illustrated embodiment, the valve members 905a-c are shown in a closed position, which is the position that the valve members assume during systole that prevents blood from flowing from the left ventricle into the left atrium. During diastole, the valve members 905a-c move to an open position, which allows blood to enter the left ventricle from the left atrium.

[0183] While the illustrated embodiments herein show a delivery catheter 100 delivering an anchoring device in the form of a docking coil 200 through the commissure A3P3, it should be understood that the delivery catheter 100 may be configured and positioned to deliver the anchoring device through the commissure A1P1 such that the anchoring device may be wrapped around the chordae tendineae within the left ventricle of the patient's heart. Additionally, while the illustrated embodiments show a delivery catheter 100 delivering an anchoring member to the mitral valve 50, and a heart valve delivery device 902 delivering a heart valve 903 to the mitral valve 50, it should be understood that the anchoring device and heart valve 903 may be applied mutatis mutandis to repair a tricuspid valve, an aortic valve, or a pulmonary valve.

[0184] Any of the embodiments disclosed herein may be utilized in such a manner. For example, any of the embodiments of the delivery catheter, docking coil, or docking coil sleeve disclosed herein may be utilized as desired. In embodiments, the components may be utilized separately as desired.

[0185] The configuration of the delivery catheter described herein provides an exemplary embodiment that allows for accurate positioning and deployment of the anchoring device. However, in some cases, retrieval or partial retrieval of the anchoring device may still be necessary at any stage during or after deployment of the anchoring device, for example, to reposition the anchoring device with its own valve or to remove the anchoring device from the implantation site. A variety of locking or unlocking mechanisms can be used to attach and / or detach the anchoring device or docking device to and from a deployment pusher that pushes the anchoring device out of the delivery catheter. Other locking or locking mechanisms are possible, for example, as described in U.S. Provisional Patent Application No. 62 / 560,962, filed September 20, 2017, which is incorporated herein by reference. The anchoring device can be connected at its proximal side to a pusher or other mechanism that can push or pull the anchoring device and easily remove it. Further features that may be utilized in connection with the systems, devices, and methods disclosed herein are described in U.S. Patent Application No. 15 / 984,661, filed May 21, 2018 (U.S. Publication No. 2018 / 0318079), which is incorporated by reference in its entirety.

[0186] In embodiments, various operations and controls of the systems and devices described herein may be automated and / or motorized. For example, the controls or knobs described above may be buttons or electrical inputs that cause the actions described with respect to the controls / knobs described above. This may be done by connecting some or all of the moveable members (directly or indirectly) to a motor (e.g., electric motor, pneumatic motor, hydraulic motor, etc.) that is activated by the button or electrical input. For example, the motor may be configured to drive a distal region of the catheter by tensioning or relaxing a tether, such as a control wire or pull wire, when in operation. Additionally or alternatively, the motor may be configured to drive an anchor or docking device within and / or across the catheter by driving a device, such as a pusher, translationally or axially relative to the catheter when in operation. Automatic stops or safeguards may be incorporated to prevent damage to the system / device and / or the patient, for example, to prevent movement of components beyond a certain point.

[0187] It should be noted that the devices and instruments described herein may be used with other surgical procedures and access points (e.g., transapical, open heart, etc.) It should also be noted that the devices described herein (e.g., deployment tools) may be used in combination with a variety of other types of anchoring devices and / or prosthetic valves that differ from the examples described herein.

[0188] For purposes of this specification, certain aspects, advantages, and novel features of the disclosed embodiments are described herein. The disclosed methods, devices, and systems should not be construed as limiting in any way. Instead, the disclosure is directed to all novel and non-obvious features and aspects of the various disclosed embodiments, alone and in various combinations and subcombinations with each other. The methods, devices, and systems are not limited to any particular aspect or feature, or combination thereof, nor do the disclosed embodiments require that any one or more particular advantages exist or problems be solved. Features, elements, or components of one embodiment can be combined with other embodiments herein.

[0189] Example 1: A system for delivering an implant to a portion of a patient's body. The system may include a delivery catheter including an elongate shaft having an internal lumen for passage of the implant and a distal end portion including a first flexible portion and a second flexible portion positioned distal to the first flexible portion, the first flexible portion including a first tether and a first linear spine positioned circumferentially opposite the first tether, the first flexible portion configured to deflect in a plane when a longitudinal force is applied to the first tether, and the second flexible portion including a second tether and a second linear spine positioned non-orthogonal and non-parallel to the first linear spine, the second flexible portion configured to deflect in a direction that is non-orthogonal and non-parallel to the plane when a longitudinal force is applied to the second tether.

[0190] Example 2: The system of any of the examples herein, particularly example 1, wherein the second tether is positioned circumferentially opposite the second linear spine.

[0191] Example 3: The system of any of the examples herein, particularly example 1 or example 2, wherein the second tether is positioned at an obtuse angle relative to the first tether.

[0192] Example 4: The system of any of the examples herein, particularly example 1, wherein the second tether is positioned orthogonal to the first tether.

[0193] Example 5: The system of any of the examples herein, particularly examples 1-4, wherein the second linear spine is positioned at an obtuse angle relative to the first linear spine.

[0194] Example 6: The system of any of the examples herein, particularly examples 1-5, wherein the second linear spine is positioned at an acute angle relative to the first tether.

[0195] Example 7: A system as described in any of the examples herein, particularly examples 1-6, wherein the direction in which the second flexible portion is configured to deflect is obliquity relative to the direction of deflection of the first flexible portion.

[0196] Example 8: The system of any of the examples herein, particularly examples 1-7, wherein the second flexible portion is configured to deflect to form a proximally extending curve.

[0197] Example 9: A system as described in any of the examples herein, particularly example 8, wherein the plane is a first plane and the curve is configured to extend in a second plane that is non-orthogonal and non-parallel to the first plane.

[0198] Example 10: The system of any of the examples herein, particularly example 9, wherein the distal tip of the second flexible portion includes an opening for the implant to pass through and be deployed from the delivery catheter.

[0199] Example 11: A system as described in any of the examples herein, particularly example 10, wherein the curve is configured to position the distal tip and extend in a plane that is parallel and offset from the plane in which the first flexible portion extends.

[0200] Example 12: The system of any of the embodiments herein, particularly embodiments 1-11, wherein the first linear spine and the second linear spine are embedded within the body of the elongate shaft.

[0201] Example 13: A system described in any of the examples herein, particularly examples 1-12, wherein the first tether comprises a pull tether configured to be retracted proximally to deflect the first flexible portion, and the second tether comprises a pull tether configured to be retracted proximally to deflect the second flexible portion.

[0202] Example 14: The system of any of the examples herein, particularly examples 1-13, further comprising an implant, the implant comprising a docking coil.

[0203] Example 15: The system of any of the embodiments herein, particularly embodiments 1-14, further comprising a steerable guide sheath including an inner lumen for passing the elongate shaft, the steerable guide sheath configured to deflect a portion of the elongate shaft positioned within the inner lumen of the steerable guide sheath.

[0204] Example 16: A system for delivering an implant to a portion of a patient's body, the system comprising: a delivery catheter including an elongate shaft having an internal lumen for passage of the implant, and a distal end portion including a flexible portion having a tether and a linear spine positioned circumferentially at an obtuse angle from the tether, the flexible portion being configured to deflect to form a curve based on a longitudinal force applied to the tether.

[0205] Example 17: A system as described in any of the examples herein, particularly example 16, wherein the curve is configured to extend proximally.

[0206] Example 18: A system as described in any of the examples herein, particularly examples 16 or 17, wherein the distal tip of the flexible portion comprises an opening for the implant to pass through and be deployed from the delivery catheter.

[0207] Example 19: The system of any of the embodiments herein, particularly embodiments 16-18, wherein the flexible portion is a second flexible portion, the tether is a second tether, the linear spine is a second linear spine, and the elongate shaft further comprises a first flexible portion positioned proximal to the second flexible portion and comprising the first tether and the first linear spine positioned circumferentially opposite the first tether, wherein the first flexible portion is configured to deflect in-plane when a longitudinal force is applied to the first tether.

[0208] Example 20: A system described in any of the examples herein, particularly example 19, wherein the plane is a first plane and the curve is configured to extend in a second plane that is non-orthogonal and non-parallel to the first plane.

[0209] Example 21: The system of any of the examples herein, particularly example 19 or 20, wherein the second flexible portion is configured to deflect in a direction that is obtuse relative to the direction of deflection of the first flexible portion.

[0210] Example 22: A system described in any of the examples herein, particularly examples 19-21, wherein the first tether comprises a pull tether configured to be retracted proximally to deflect the first flexible portion, and the second tether comprises a pull tether configured to be retracted proximally to deflect the second flexible portion.

[0211] Example 23: The system described in any of the examples herein, particularly examples 19-22, wherein the first linear spine and the second linear spine are embedded within the body of the elongate shaft.

[0212] Example 24: The system of any of the examples herein, particularly examples 16-23, further comprising an implant, the implant comprising a docking coil.

[0213] Example 25: A system described in any of the embodiments herein, particularly embodiments 16-24, further comprising a steerable guide sheath including an inner lumen for passing the elongate shaft, the steerable guide sheath configured to deflect a portion of the elongate shaft positioned within the inner lumen of the steerable guide sheath.

[0214] Example 26: A system for delivering an implant to a portion of a patient's body. The system may include a delivery catheter including an elongate shaft having an internal lumen for passage of the implant and a distal end portion including a first flexible portion and a second flexible portion positioned distal to the first flexible portion, the first flexible portion including a first tether and a first linear spine positioned circumferentially opposite the first tether, the first flexible portion configured to deflect in a first plane when a longitudinal force is applied to the first tether, the second flexible portion including a second tether positioned orthogonal to the first tether, a second linear spine positioned circumferentially opposite the second linear spine, and a third tether positioned circumferentially opposite the first tether, the second flexible portion configured to deflect in a second plane that is orthogonal to the first plane when a longitudinal force is applied to the second tether, and the second flexible portion configured to deflect in the first plane when a longitudinal force is applied to the third tether.

[0215] Example 27: Any of the examples herein, particularly the system of Example 26, wherein the second flexible portion is configured to deflect in a direction that is obtuse relative to the deflection direction of the first flexible portion when a longitudinal force is applied to both the second tether and the third tether.

[0216] Example 28: A system described in any of the examples herein, particularly examples 26 or 27, wherein the second flexible portion is configured to deflect to form a proximally extending curve.

[0217] Example 29: A system described in any of the examples herein, particularly Example 28, wherein the curve is configured to extend in a third plane that is non-orthogonal and non-parallel to the first plane when a longitudinal force is applied to both the second tether and the third tether.

[0218] Example 30: A system as described in any of the examples herein, particularly examples 26-29, wherein the distal tip of the second flexible portion includes an opening through which the implant passes and is deployed from the delivery catheter.

[0219] Example 31: A system described in any of the examples herein, particularly examples 26-30, wherein the second flexible portion includes a third linear spine positioned circumferentially opposite the third tether.

[0220] Example 32: A system described in any of the examples herein, particularly examples 26-31, wherein the first linear spine and the second linear spine are embedded within the body of the elongate shaft.

[0221] Example 33: A system described in any of the examples herein, particularly examples 26-32, wherein the first tether comprises a pull tether configured to be stored proximally to deflect the first flexible portion, the second tether comprises a pull tether configured to be stored proximally to deflect the second flexible portion, and the third tether is configured to be stored proximally to deflect the second flexible portion.

[0222] Example 34: The system of any of the examples herein, particularly examples 26-33, further comprising an implant, the implant comprising a docking coil.

[0223] Example 35: A system described in any of the examples herein, particularly examples 26-34, further comprising a steerable guide sheath including an inner lumen for passing the elongate shaft, the steerable guide sheath configured to deflect a portion of the elongate shaft positioned within the inner lumen of the steerable guide sheath.

[0224] Example 36: A system. A system may include a docking coil configured to dock an implant within a portion of a patient's body, and a docking coil sleeve having an internal lumen through which the docking coil is configured to slide, the docking coil sleeve including a tether extending along at least a portion of the docking coil sleeve and configured to deflect the docking coil sleeve.

[0225] Example 37: The system of any of the examples herein, especially example 36, wherein the docking coil sleeve comprises a lubricious outer surface facing opposite the internal lumen.

[0226] Example 38: A system described in any of the examples herein, particularly example 36 or example 37, wherein the docking coil sleeve includes a distal tip having an opening for the docking coil to pass through and deploy from the docking coil sleeve.

[0227] Example 39: A system as described in any of the examples herein, particularly example 38, wherein the tether is configured to deflect the distal tip.

[0228] Example 40: A system described in any of the examples herein, particularly example 39, wherein the docking coil sleeve is configured to form a coil and the tether is configured to deflect the distal tip radially inward when the docking coil sleeve forms the coil.

[0229] Example 41: A system described in any of the examples herein, particularly examples 36-40, wherein the docking coil sleeve includes a braid positioned at a distal end portion of the docking coil sleeve.

[0230] Example 42: A system as described in any of the examples herein, particularly example 41, wherein the braid has increasing flexibility in a direction toward the distal tip of the docking coil sleeve.

[0231] Example 43: The system described in any of the examples herein, particularly examples 36-42, wherein the docking coil sleeve includes a spine extending along at least a portion of the docking coil sleeve.

[0232] Example 44: A system as described in any of the examples herein, particularly example 43, wherein the spines are positioned circumferentially opposite the tether.

[0233] Example 45: A system described in any of the examples herein, particularly examples 36-44, wherein the tether comprises a pull tether configured to be retracted proximally to deflect the docking coil sleeve.

[0234] Example 46: A system. The system may include a docking coil configured for docking with an implant within a portion of a patient's body, the docking coil extending to a leading tip and having an orientation, and a docking coil sleeve having an internal lumen through which the docking coil is configured to slide, the docking coil sleeve including a leading portion extending to the leading tip and having an orientation different from the orientation of the leading portion of the docking coil, the leading tip of the docking coil sleeve configured to slide relative to the leading tip of the docking coil and deflect the leading tip of the docking coil or the leading tip of the docking coil sleeve radially inwardly or outwardly.

[0235] Example 47: A system described in any of the embodiments herein, particularly Example 46, wherein the orientation of the leading portion of the docking coil is configured to form a diameter smaller than the diameter of the leading portion of the docking coil sleeve, and sliding the leading tip of the docking coil distally relative to the leading tip of the docking coil sleeve deflects the leading tip of the docking coil sleeve radially inward.

[0236] Example 48: A system described in any embodiment herein, particularly example 46 or example 47, wherein sliding the leading tip of the docking coil proximally relative to the leading tip of the docking coil sleeve deflects the leading tip of the docking coil sleeve radially outward.

[0237] Example 49: The system of any of the examples herein, particularly examples 46-48, wherein the leading portion of the docking coil has a preset radius of curvature.

[0238] Example 50: A system described in any of the examples herein, particularly example 49, wherein the leading portion of the docking coil sleeve has a preset radius of curvature that is greater than the preset radius of curvature of the leading portion of the docking coil.

[0239] Example 51: A system described in any of the examples herein, particularly example 46, wherein the orientation of the leading portion of the docking coil is configured to form a diameter larger than the diameter of the leading portion of the docking coil sleeve, and sliding the leading tip of the docking coil sleeve distally relative to the leading tip of the docking coil deflects the leading tip of the docking coil radially inward.

[0240] Example 52: A system described in any of the embodiments herein, particularly example 51, wherein the docking coil includes one or more notches on an inner curved portion of the docking coil, the one or more notches being configured to allow the leading tip of the docking coil to deflect.

[0241] Example 53: A system described in any of the embodiments herein, particularly Example 51 or Example 52, wherein the leading portion of the docking coil sleeve has a preset radius of curvature that is smaller than the preset radius of curvature of the leading portion of the docking coil.

[0242] Example 54: The system of any of the examples herein, particularly examples 46-53, further comprising a braid positioned on the leading portion of the docking coil sleeve.

[0243] Example 55: The system described in any of the examples herein, particularly examples 46-54, further comprising a spine extending along the leading portion of the docking coil sleeve.

[0244] Example 56: A method comprising advancing a delivery catheter to a location within a patient's body, the delivery catheter comprising an elongate shaft having an internal lumen for passage of an implant, and a distal end portion including a first flexible portion and a second flexible portion positioned distal to the first flexible portion, the first flexible portion comprising a first tether and a first linear spine positioned circumferentially opposite the first tether, the first flexible portion configured to deflect in a plane when a longitudinal force is applied to the first tether, the second flexible portion comprising a second tether and a second linear spine positioned non-orthogonal and non-parallel to the first linear spine, the second flexible portion configured to deflect in a direction that is non-orthogonal and non-parallel to the plane when a longitudinal force is applied to the second tether. The method may include deploying the implant from the internal lumen to an implantation site within the patient's body.

[0245] Example 57: The method of any of the examples herein, especially example 56, further comprising deflecting the second flexible portion to form a proximally extending curve.

[0246] Example 58: The method of any of the examples herein, particularly example 57, wherein the plane is a first plane and the curve extends in a second plane that is non-orthogonal and non-parallel to the first plane.

[0247] Example 59: The method of any of the embodiments herein, particularly example 57 or example 58, wherein the curve forms a height between the first flexible portion and the distal tip of the second flexible portion.

[0248] Example 60: The method of any of the examples herein, particularly example 59, wherein the first flexible portion is positioned within the atrium of the patient's heart and has a height toward the ventricle.

[0249] Example 61: A method as described in any of the examples herein, particularly example 59 or 60, wherein the curve positions the distal tip and extends in a plane that is parallel and offset from the plane in which the first flexible portion extends.

[0250] Example 62: The method of any of the examples herein, particularly examples 56-61, further comprising retracting the second tether to deflect the second flexible portion.

[0251] Example 63: The method of any of the examples herein, particularly examples 56-62, further comprising retracting the first tether to deflect the first flexible portion.

[0252] Example 64: The method of any of the examples herein, particularly examples 56-63, wherein the elongate shaft is positioned within an atrium of the patient's heart, and the method further comprises deflecting the second flexible portion toward a commissure of the patient's mitral valve.

[0253] Example 65: The method of any of the examples herein, particularly examples 56-64, wherein the implant comprises a docking coil, and the method further comprises deploying the docking coil around the leaflets of the patient's mitral valve.

[0254] Example 66: The method may include advancing a delivery catheter to a location within a patient's body. The delivery catheter may include an elongate shaft having an internal lumen for passage of the implant, and a distal end portion including a first flexible portion and a second flexible portion positioned distal to the first flexible portion, the first flexible portion including a first tether and a first linear spine positioned circumferentially opposite the first tether, the first flexible portion configured to deflect in a plane when a longitudinal force is applied to the first tether, and the second flexible portion including a second tether and a second linear spine positioned non-orthogonal and non-parallel to the first linear spine, the second flexible portion configured to deflect in a direction non-orthogonal and non-parallel to the plane when a longitudinal force is applied to the second tether. The method may include deploying the implant from the internal lumen to an implantation site within the patient's body.

[0255] Example 67: The method of any of the examples herein, especially example 66, further comprising deflecting the second flexible portion to form a proximally extending curve.

[0256] Example 68: The method of any of the examples herein, particularly example 67, wherein the curve extends in a second plane that is non-orthogonal and non-parallel to the first plane.

[0257] Example 69: The method of any of the embodiments herein, particularly example 67 or example 68, wherein the curve forms a height between the first flexible portion and the distal tip of the second flexible portion.

[0258] Example 70: The method of any of the examples herein, particularly example 69, wherein the first flexible portion is positioned within the atrium of the patient's heart and the height is toward the ventricle.

[0259] Example 71: A method as described in any of the examples herein, particularly example 69 or 70, wherein the curve positions the distal tip and extends in a plane that is parallel and offset from the plane in which the first flexible portion extends.

[0260] Example 72: The method of any of the examples herein, particularly examples 66-71, further comprising retracting both the second tether and the third tether to deflect the second flexible portion.

[0261] Example 73: The method of any of the examples herein, particularly examples 66-72, further comprising retracting the first tether to deflect the first flexible portion.

[0262] Example 74: The method of any of the examples herein, particularly examples 66-73, wherein the elongate shaft is positioned within an atrium of the patient's heart, and the method further comprises deflecting the second flexible portion toward a commissure of the patient's mitral valve.

[0263] Example 75: The method of any of the examples herein, especially examples 66-74, wherein the implant comprises a docking coil, and the method further comprises deploying the docking coil around the leaflets of the patient's mitral valve.

[0264] Example 76: A method comprising deploying a docking coil from a docking coil sleeve to an implantation site within a patient's body, the docking coil configured to dock with an implant within the patient's body, the docking coil sleeve having an internal lumen through which the docking coil is configured to slide, and including a tether extending along at least a portion of the docking coil sleeve and configured to deflect the docking coil sleeve.

[0265] Example 77: The method of any of the examples herein, especially example 76, further comprising deflecting the docking coil sleeve with a tether.

[0266] Example 78: The method of any of the examples herein, especially example 76 or 77, further comprising retracting the tether to deflect the docking coil sleeve.

[0267] Example 79: The method of any of the embodiments herein, particularly embodiments 76-78, wherein the distal tip of the docking coil sleeve overhangs the distal tip of the docking coil.

[0268] Example 80: The method of any of the examples herein, especially examples 76-79, wherein the docking coil sleeve comprises a braid positioned at a distal end portion of the docking coil sleeve.

[0269] Example 81: The method of any of the examples herein, especially example 80, wherein the braid has increasing flexibility in a direction toward the distal tip of the docking coil sleeve.

[0270] Example 82: The method of any of the examples herein, particularly examples 76-81, wherein the docking coil sleeve includes a spine extending along at least a portion of the docking coil sleeve and positioned circumferentially opposite the tether.

[0271] Example 83: The method of any embodiment herein, particularly embodiments 76-82, wherein the implantation site is the patient's mitral valve.

[0272] Example 84: The method described in any of the examples herein, particularly example 83, further comprising forming a docking coil sleeve into a coil around the leaflets of the patient's mitral valve and utilizing a tether to deflect the docking coil sleeve radially inward or outward.

[0273] Example 85: A method as described in any of the examples herein, particularly example 83 or example 84, further comprising extending a docking coil sleeve and a docking coil around the leaflets of the patient's mitral valve, retracting the docking coil relative to the docking coil sleeve, and deploying the docking coil to the patient's mitral valve.

[0274] Example 86: A method comprising: deploying a docking coil from a docking coil sleeve to an implantation site within a patient's body, the docking coil configured to dock with an implant within a portion of the patient's body, the docking coil including a leading portion extending to a leading tip and having an orientation, the docking coil having an internal lumen configured to slide therethrough, and a docking coil sleeve extending to the leading tip and having an orientation different from the orientation of the leading portion of the docking coil, the leading tip of the docking coil sleeve configured to slide relative to the leading tip of the docking coil to deflect the leading tip of the docking coil or the leading tip of the docking coil sleeve radially inward or outward.

[0275] Example 87: The method described in any of the examples herein, particularly example 86, further comprising sliding the leading tip of the docking coil distally relative to the leading tip of the docking coil sleeve to deflect the leading tip of the docking coil sleeve radially inward.

[0276] Example 88: The method described in any of the examples herein, particularly example 86 or example 87, further comprising sliding the leading tip of the docking coil proximally relative to the docking coil sleeve to deflect the leading tip of the docking coil sleeve radially outward.

[0277] Example 89: The method of any of the examples herein, especially examples 86-88, wherein the orientation of the leading portion of the docking coil is configured to form a diameter smaller than the diameter of the leading portion of the docking coil sleeve.

[0278] Example 90: A method as described in any of the examples herein, particularly example 86, wherein the orientation of the leading portion of the docking coil is configured to form a diameter greater than a diameter of the leading portion of the docking coil sleeve, and sliding the leading tip of the docking coil sleeve distally relative to the leading tip of the docking coil deflects the leading tip of the docking coil radially inward.

[0279] Example 91: A method as described in any of the examples herein, particularly example 90, wherein the docking coil includes one or more notches on an inner curved portion of the docking coil, the one or more notches being configured to allow the leading tip of the docking coil to deflect.

[0280] Example 92: The method of any of the examples herein, especially examples 86-91, wherein the docking coil sleeve includes a spine extending along a leading portion of the docking coil sleeve.

[0281] Example 93: The method of any of the examples herein, especially examples 86-92, wherein the docking coil sleeve comprises a braid positioned on a leading portion of the docking coil sleeve.

[0282] Example 94: The method of any of the examples herein, particularly Examples 86-93, wherein the implantation site is the patient's mitral valve.

[0283] Example 95: The method of any of the examples herein, particularly examples 86 to 94, further comprising extending a docking coil sleeve and a docking coil around the leaflets of the patient's mitral valve, retracting the docking coil sleeve relative to the docking coil, and deploying the docking coil to the patient's mitral valve.

[0284] Any of the features of any of the examples, including but not limited to any of the first to ninety-five examples described above, are applicable to all other aspects and embodiments identified herein, including but not limited to any embodiment of any of the first to ninety-five examples mentioned above. Furthermore, any feature of the various example embodiments, including but not limited to any embodiment of the first to ninety-five examples described above, may be combined, in part or in whole, independently with other examples described herein, e.g., one, two, or more examples may be combined in whole or in part. Furthermore, any of the features of the various examples, including but not limited to any embodiment of any of the first to ninety-five examples described above, may be optional with respect to other examples. Any of the methods of an example may be performed by a system or device of another example, and any of the aspects or embodiments of the system or device may be configured to perform the method of another aspect or embodiment, including but not limited to any embodiment of any of the first to ninety-five examples mentioned above.

[0285] Although some operations of the disclosed embodiments are described in a specific sequential order for convenience of presentation, it should be understood that this method of description encompasses rearrangements unless a specific order is required by specific language. For example, operations described sequentially may in some cases be rearranged or performed simultaneously. Furthermore, for simplicity, the accompanying drawings may not show various ways in which the disclosed methods may be combined with other methods. Furthermore, terms such as "provide" or "achieve" are sometimes used in this specification to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the specific implementation and are easily recognizable by those skilled in the art. Steps of various methods in this specification may be combined.

[0286] In view of the many possible embodiments to which the principles of the present disclosure may be applied, it should be recognized that the illustrated embodiments are merely preferred embodiments of the present disclosure and should not be considered as limiting the scope of the present disclosure, which is rather defined by the following claims.

Claims

1. 1. A system (2) for delivering an implant to a portion of a patient's body, said system (2) comprising: A delivery catheter (100), comprising: a delivery catheter (100) comprising an elongate shaft (104) having an internal lumen for passage of the implant (200) therethrough, and a distal end portion (102) including a first flexible portion (140) and a second flexible portion (142) positioned distal to the first flexible portion (140); the first flexible portion (140) includes a first tether (144) and a first linear spine (150; 167) positioned circumferentially opposite the first tether (144), the first flexible portion (140) being configured to deflect in a plane when a longitudinal force is applied to the first tether (144); the second flexible portion (142) comprises a second tether (154) and a second linear spine (164; 171) positioned non-orthogonally and non-parallel to the first linear spine (150; 167), the second linear spine (164; 171) being disposed offset from a circumferential position of the first linear spine (150; 167), the second linear spine (164; 171) being positioned at an obtuse angle to the second tether (154) between a circumferentially opposed position and a circumferential position of the first tether (144), and the second tether (154) being positioned at an obtuse angle to the first tether (144); The system (2), wherein the second flexible portion (142) is configured to deflect in a direction that is non-orthogonal and non-parallel to the plane when a longitudinal force is applied to the second tether (154).

2. The system (2) of claim 1, wherein the second tether (154) is positioned orthogonal to the first tether (144).

3. The system (2) according to claim 1 or 2, wherein the second linear spine (164; 171) is positioned at an obtuse angle relative to the first linear spine (150; 167).

4. The system (2) of any one of claims 1 to 3, wherein the direction in which the second flexible portion (142) is configured to deflect is at an obtuse angle relative to the direction of deflection of the first flexible portion (140).

5. The system (2) of any one of claims 1 to 4, wherein the second flexible portion (142) is configured to deflect to form a proximally extending curve.

6. 6. The system (2) of claim 5, wherein the plane is a first plane and the curve is configured to extend in a second plane that is non-orthogonal and non-parallel to the first plane.

7. The system of claim 6 , wherein the distal tip of the second flexible portion includes an opening through which the implant passes for deployment from the delivery catheter.

8. The system (2) according to any one of the preceding claims, wherein the first linear spine (150; 167) and the second linear spine (164; 171) are embedded within a body of the elongate shaft (104).

9. The system (2) of any one of claims 1 to 8, wherein the first tether (144) comprises a pull tether configured to be retracted proximally to deflect the first flexible portion (140), and the second tether comprises a pull tether configured to be retracted proximally to deflect the second flexible portion (142).

10. The system (2) of any one of claims 1 to 9, further comprising the implant (200), the implant (200) comprising a docking coil.

11. 11. The system (2) of any one of claims 1 to 10, further comprising a steerable guide sheath (20) including an inner lumen for passing the elongate shaft (104), the steerable guide sheath (20) configured to deflect a portion of the elongate shaft (104) when the elongate shaft (104) is disposed within the inner lumen of the steerable guide sheath (20).

12. A docking coil sleeve (212), comprising: a docking coil sleeve having an internal lumen (220) within which the docking coil (200) is configured to slide, the docking coil sleeve including a tether (224) extending along at least a portion of the docking coil sleeve (212) and configured to deflect the docking coil sleeve (212); The system (2) of claim 10, comprising:

13. The system (2) of claim 12, wherein the docking coil sleeve (212) includes a lubricious outer surface (218) facing opposite the internal bore (220).

14. 13. The system (2) of claim 11 or 12, wherein the docking coil sleeve (212) includes a distal tip having an opening for the docking coil (200) to pass through and deploy from the docking coil sleeve (212), and in particular, the tether (224) is configured to deflect the distal tip (214).

15. A system (2) as described in claim 1 or 2, further comprising a third tether (178) positioned circumferentially opposite the first tether (144) and extending into the second flexible portion (142), the third tether (178) configured to deflect the second flexible portion (142) in a direction different from the direction in which the second flexible portion (142) is configured to deflect when a longitudinal force is applied to the third tether (178).

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