Systems, tools and methods for delivering implants and catheters for prosthetic valves

Abstract

To provide a deployment tool intended to facilitate implantation of an implant, such as a prosthetic device (e.g., a prosthetic valve), at one of the native mitral, aortic, tricuspid, or pulmonary valve regions of a human heart.SOLUTION: The delivery catheter, in various embodiments, is configured to deliver the anchoring device to an annulus of a native valve of a patient's heart, where the anchoring device can better secure the prosthesis to the native valve annulus. The sheath catheter may be utilized to deliver the delivery catheter and the catheter for deploying the prosthetic valve to the anchor device.SELECTED DRAWING: Figure 27

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 63 / 109,563, filed November 4, 2020, the entire contents of which are incorporated herein by reference. [Background technology]

[0002] The present disclosure generally relates to deployment tools for delivering anchoring devices, such as prosthetic docking devices, that support prosthetic devices and methods of using the same. For example, the present disclosure relates to the replacement of malformed and / or dysfunctional heart valves utilizing a flexible delivery catheter to deploy anchoring devices that support a prosthetic heart valve at an implant site, and methods of implanting such anchoring devices and / or prosthetic heart valves using a delivery catheter. A sheath catheter may be utilized for passing the delivery catheter.

[0003] 1A-1B, a native mitral valve 50 controls blood flow from the left atrium 51 to the left ventricle 52 of a human heart. Similarly, a tricuspid valve 59 controls blood flow between the right atrium 56 and the right ventricle 61. The mitral valve has a distinct anatomical structure from 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 edges of the leaflets when they are closed together.

[0004] When operating properly, the anterior leaflet 54 and posterior leaflet 53 of the mitral valve function together as a one-way valve, allowing 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 cords 62, called chordae tendineae, connect the leaflets to the papillary muscles within the left ventricle. The chordae tendineae 62 are shown schematically in both the cross-sectional view of the heart in Figure 1A and the superior view of the mitral valve in Figure 1B.

[0005] Problems with the proper function of the mitral valve are a type of valvular heart disease. Vascular heart disease can also affect other heart valves, including the tricuspid valve. A common form of vascular 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 fails to close properly during ventricular systole, causing blood to flow backward from the left ventricle into the left atrium. Mitral regurgitation has different causes, including leaflet prolapse, dysfunctional papillary muscles, problems with the chordae tendineae, and / or stretching of the mitral annulus due to left ventricular dilation. In addition to mitral regurgitation, mitral valve narrowing or mitral stenosis is another example of vascular heart disease. In tricuspid regurgitation, the tricuspid valve does not close properly, allowing blood to back up from the right ventricle into the right atrium.

[0006] Like 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) is crimped onto the end of a flexible and / or steerable catheter, advanced through a blood vessel connected to the heart to the implantation site, and then expanded to its functional size by, for example, 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 expanding the THV to its functional state. These delivery catheters and implantation techniques are generally more developed for implantation or use with the aortic valve, but do not address the unique anatomical structures and challenges of other valves. Summary of the Invention

[0007] This Summary is intended to provide some examples and is not intended to limit the scope of the present invention in any way. For example, any features included in the examples 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 described elsewhere in this disclosure may be included in the examples summarized herein. [Means for solving the problem]

[0008] Tools and methods for mitral and tricuspid valve replacement are provided, including those for adapting various types of valves (e.g., those designed for aortic valve replacement or other locations) for use in the mitral and tricuspid locations. One way to adapt these other prosthetic valves in the mitral or tricuspid location is to deploy the prosthetic valve within an anchor or other docking device / station that creates a more appropriately shaped implant site with the native valve annulus. The anchor or other docking device / station herein allows for more secure implantation of the prosthetic valve while reducing or eliminating leakage around the valve after implantation.

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

[0010] Described herein are embodiments of deployment tools and methods of using same that assist in delivering prosthetic devices in one of the native mitral, aortic, tricuspid, or pulmonary valve regions of the human heart. The disclosed deployment tools can be used to deploy implants, such as anchoring devices (e.g., prosthetic docking devices, prosthetic valve docking devices, etc.), such as helical anchoring devices or anchoring devices having multiple turns or coils, at an implantation site to provide an underlying support structure upon which a prosthetic heart valve can be implanted. The deployment tools can include a distal bend section to guide the positioning of the anchor or anchoring device once it is implanted.

[0011] In one embodiment, a delivery catheter for delivering an implant in the form of an anchoring device to the annulus of a native valve of a patient's heart, where the anchoring device is configured to secure a prosthesis (e.g., a prosthetic heart valve) to the annulus of the native valve, includes a flexible tube, a first pull wire, and a second pull wire. The flexible tube has a proximal portion having a first end, a distal portion having a second end, and a lumen extending between the first and second ends. The lumen is sized to allow passage of the anchoring device. The distal portion includes a first bend section and a second bend section. The delivery catheter can be configured such that actuation of the first and second pull wires causes the flexible tube to move from a first configuration to a second configuration. When the flexible tube is in the second configuration, the first bend section can form a first curved portion and the second bend section can form a substantially circular and substantially planar portion.

[0012] The delivery catheter can have a first ring and a second ring. The first ring can be positioned at a first actuation point, and a first pull wire can be attached to the first ring. The second ring can be positioned at a second actuation point, and a second pull wire can be attached to the second ring. The first pull wire can be circumferentially offset from the second pull wire by about 65 degrees to about 115 degrees, such as about 90 degrees.

[0013] The catheter may include a third ring disposed between the proximal portion and the second ring. The first spine may be disposed between the first ring and the second ring. The second spine may be disposed between the second ring and the third ring. The first spine may be configured to limit compressive movement between the first ring and the second ring when the flexible tube is moved to the second configuration. The second spine may be configured to limit bending by the first pull wire between the second ring and the third ring when the flexible tube is moved to the second configuration. The ratio of the Shore D hardness of the first spine to the Shore D hardness of the second spine may be between about 1.5:1 and about 6:1.

[0014] The flexible end can be configured to be angled relative to the main portion of the circular or curved planar portion. For example, the vertical displacement between the flexible end and the main portion can be from about 2 mm to about 10 mm.

[0015] The catheter may also include a first coiled sleeve extending around at least a portion of the first pull wire and / or a second coiled sleeve extending around at least a portion of the second pull wire.

[0016] In a method using a delivery catheter to deliver an anchoring device to a native valve of a patient's heart, the delivery catheter can be advanced into the heart (e.g., into a chamber of the heart, such as the atrium). A first curved portion can be created in a first bent section of the delivery catheter and can be generally circular or curved (e.g., curved to mimic or resemble a circular shape), and a generally flat portion can be created in a second bent section of the delivery catheter. A distal opening at the end of the generally circular portion can be positioned toward the commissures of the native valve. The anchoring device is delivered through the catheter to the native valve. The height or angle of the distal opening of the delivery catheter can optionally be adjusted so that at least a portion of the delivery catheter is substantially parallel to the plane of the annulus of the native valve or a plane passing through the native annulus.

[0017] In another embodiment, a method of delivering an anchoring device to an annulus of a native valve of a patient's heart using a delivery catheter, the anchoring device being configured to secure a prosthesis to the annulus of the native valve, includes: advancing the delivery catheter into the heart (e.g., into a chamber of the heart, such as an atrium) bending the delivery catheter at least partially around the annulus of the native valve so that a distal opening of the delivery catheter is positioned near a commissure of the native valve; and adjusting at least one of a height or an extension angle of the delivery catheter so that at least a portion of the delivery catheter is substantially parallel to a plane containing the annulus of the native valve. When the native valve is a mitral valve, the delivery catheter is advanced from the right atrium to the left atrium through the atrial septum.

[0018] In one embodiment, a system for insertion into a portion of a patient's body may include a sheath having a proximal portion, a distal portion, and an inner lumen for passing a catheter or implant through the inner lumen. The system may include an outer housing positioned in the proximal portion of the sheath and having an inner surface defining a cavity. The system may include an inner housing positioned within the cavity of the outer housing and having an outer surface and an inner surface, the proximal portion of the sheath being sandwiched between the outer surface of the inner housing and the inner surface of the outer housing, the inner surface of the inner housing defining a lumen for passing a catheter or implant through the inner lumen of the sheath.

[0019] In one embodiment, a method includes inserting a sheath catheter into a patient's vascular system. The sheath catheter may include a sheath having a proximal portion, a distal portion, and an inner lumen for passing a catheter or implant through the inner lumen, an outer housing positioned in the proximal portion of the sheath and having an inner surface defining a cavity, and an inner housing positioned within the cavity of the outer housing and having an outer surface and an inner surface, wherein the proximal portion of the sheath is sandwiched between an outer surface of the inner housing and the inner surface of the outer housing, and the inner surface of the inner housing defines a lumen for passing a catheter or implant through the inner lumen of the sheath.

[0020] The method may include passing a catheter or implant through a lumen of the inner housing and an inner lumen of the sheath.

[0021] In one embodiment, a method of forming at least a portion of a sheath catheter is disclosed. The method may include inserting an inner housing into a cavity of an outer housing defined by an inner surface of the outer housing, the inner housing having an outer surface and an inner surface defining a lumen for passing a catheter or implant through the lumen. The method may include sandwiching a proximal portion of a sheath of the sheath catheter between the inner surface of the outer housing and the outer surface of the inner housing, the sheath having an inner lumen for passing a catheter or implant through the lumen of the inner housing.

[0022] The systems and catheters summarized herein may also include any of the features, components, elements, etc. described elsewhere in this disclosure, and the methods summarized herein may also include any of the steps described elsewhere in this disclosure. [Brief explanation of the drawings]

[0023] The foregoing and other objects, features, and advantages of the present invention will become more apparent from the following detailed description taken in conjunction with the accompanying drawings. [Figure 1A] FIG. 1A shows a schematic cross-sectional view of the human heart. [Figure 1B] FIG. 1B shows a schematic superior view of the annulus of the mitral valve of the heart. [Figure 2A] FIG. 2A shows a perspective view of an exemplary helical anchoring device. [Figure 2B] FIG. 2B shows a partial perspective view of an exemplary delivery device for implanting an anchoring device into a native valve of the heart using a transseptal technique. [Figure 2C] FIG. 2C shows a cross-sectional view of an exemplary prosthetic heart valve and anchoring device implanted into a native valve of the heart. [Figure 3A]FIG. 3A shows a perspective view of an exemplary distal section of a delivery catheter used as part of an exemplary delivery apparatus for implanting an anchoring device. [Figure 3B] FIG. 3B is a cross-sectional view of some links of the distal section of FIG. 3A. [Figure 4] FIG. 4 is a perspective view of the distal section of the delivery catheter in a bent or curved configuration. [Figure 5] FIG. 5 is a plan view of an exemplary laser-cut sheet that can be used to form the distal section of a delivery catheter. [Figure 6] FIG. 6 is a plan view of another exemplary laser-cut sheet that can be used to form the distal section of a delivery catheter. [Figure 7] FIG. 7 is a plan view of another exemplary laser-cut sheet that can be used to form the distal section of a delivery catheter. [Figure 8] FIG. 8 shows a perspective view of a bent or curved configuration of the distal section of a delivery catheter that can be used to implant an anchoring device into a native valve, for example, using a transseptal technique. [Figure 9A] FIG. 9A is a lateral cutaway view of a portion of a patient's heart showing an exemplary delivery device entering the left atrium through the fossa ovalis in an exemplary manner. [Figure 9B] FIG. 9B shows the delivery device of FIG. 9A entering the left atrium of the patient's heart in the position shown in FIG. 9A, as shown from a view along line BB in FIG. 9A. [Figure 9C] FIG. 9C shows the delivery device of FIG. 9A in a second position. [Figure 9D] FIG. 9D shows the delivery device of FIG. 9A in a second position shown in FIG. 9C, as seen from a view along line DD in FIG. 9C. [Figure 9E] FIG. 9E shows the delivery device of FIG. 9A in a third position. [Figure 9F] FIG. 9F shows the delivery device of FIG. 9A in a third position shown in FIG. 9E, as seen from a view along line FF in FIG. 9E. [Figure 9G] FIG. 9G shows the delivery device of FIG. 9A in a fourth position. [Figure 9H] FIG. 9H shows the delivery device of FIG. 9A in a fourth position shown in FIG. 9G, as seen from a view along line HH in FIG. 9G. [Figure 9I] FIG. 91 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 9J] FIG. 9J shows the anchoring device of FIG. 91 further wrapped around the chordae tendineae and valve leaflets within the left ventricle of a patient's heart when delivered by the delivery device of FIG. 9A. [Figure 9K] FIG. 9K shows the anchoring device of FIG. 9I further wrapped around the chordae tendineae and valve leaflets within the left ventricle of a patient's heart when delivered by the delivery device of FIG. 9A. [Figure 9L] FIG. 9L is a view looking down into the left atrium of a patient showing the delivery device of FIG. 9A after the anchoring device of FIG. 91 has been wrapped around the chordae tendineae and valve leaflets in the left ventricle of the patient's heart. [Figure 9M] FIG. 9M shows the delivery device of FIG. 9A within the left atrium of a patient's heart with the delivery device retracted to deliver a portion of the anchor device within the left atrium of the patient's heart. [Figure 9N] FIG. 9N shows the delivery device of FIG. 9A within the left atrium of the patient's heart with the delivery device retracted to deliver an additional portion of the anchoring device within the left atrium of the patient's heart. [Figure 9O] FIG. 9O shows the delivery device of FIG. 9A within the left atrium of a patient's heart, with the anchor device exposed and shown firmly connected to a pusher within the left atrium of the patient's heart. [Figure 9P] FIG. 9P shows the delivery device of FIG. 9A within the left atrium of a patient's heart with the anchor device completely removed from the delivery device and loosely and removably attached to the pusher by sutures. [Figure 9Q] FIG. 9Q is a cutaway 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 9R] FIG. 9R shows the heart valve of FIG. 9Q being further delivered to the patient's mitral valve by a heart valve delivery device. [Figure 9S] FIG. 9S shows the heart valve of FIG. 9Q opened by inflation of a balloon to expand the heart valve and attach it to the patient's mitral valve. [Figure 9T] FIG. 9T shows the heart valve of FIG. 9Q attached to the mitral valve of a patient's heart and secured by the anchoring device of FIG. 9I. [Figure 9U] FIG. 9U is an elevational view of the left ventricle mitral valve showing the prosthetic heart valve of FIG. 9Q attached to the mitral valve of a patient's heart from a view along line UU of FIG. 9T. [Figure 10] FIG. 10 shows a perspective view of a helical configuration of the distal section of a delivery catheter that can be used to implant an anchoring device into the native valve, which can optionally be used during a transseptal technique. [Figure 11] FIG. 11 shows a perspective view of a hybrid configuration of the distal section of a delivery catheter that can be used to implant an anchoring device into the native valve, which can optionally be used during a transseptal technique. [Figure 12] FIG. 12 shows a partial perspective view of an exemplary delivery device that can be used to implant an anchoring device into the native mitral valve, for example, using another transseptal technique. [Figure 13] FIG. 13 shows a schematic side view of an exemplary distal section of a delivery catheter having an exemplary two control wire or pull wire system that may be used in various delivery catheters or delivery devices herein. [Figure 14] FIG. 14 shows a cross-sectional view of the multi-lumen extruded portion of the delivery catheter of FIG. 13 taken in a plane perpendicular to the longitudinal axis of the delivery catheter. [Figure 15] FIG. 15 shows a schematic perspective view of the delivery catheter of FIGS. 13-14 in a partially actuated state. [Figure 16] FIG. 16 shows a schematic perspective view of the delivery catheter of FIGS. 13-15 in a fully actuated state. [Figure 17A]17A-17C show perspective views of an exemplary lock or locking mechanism for an anchoring device. [Figure 17B] Same as above. [Figure 17C] Same as above. [Figure 17D] FIG. 17D is a cross-sectional view of the lock or locking mechanism of FIGS. 17A-17C. [Figure 18A] 18A-18C show perspective views of another exemplary lock or locking mechanism for an anchoring device, according to one embodiment. [Figure 18B] Same as above. [Figure 18C] Same as above. [Figure 19] FIG. 19 shows a perspective view of an exemplary distal section of a delivery catheter that can be used as part of a delivery apparatus for implanting an anchoring device. [Figure 20A] FIG. 20A is an end view of another exemplary embodiment of a delivery catheter. [Figure 20B] FIG. 20B is a cross-sectional view taken along the plane indicated by line BB in FIG. 20A. [Figure 20C] FIG. 20C is a cross-sectional view taken along the plane indicated by line CC in FIG. 20C. [Figure 20D] FIG. 20D is a cross-sectional view taken along the plane indicated by line DD in FIG. 20C. [Figure 20E] FIG. 20E is a cross-sectional view taken along the plane indicated by line EE in FIG. 20C. [Figure 21A] FIG. 21A shows a schematic perspective view of the distal section of the delivery catheter of FIGS. 20A-20E in a partially actuated state. [Figure 21B] FIG. 21B shows a schematic perspective view of the distal section of the delivery catheter of FIGS. 20A-20E in a more actuated state. [Figure 22A] FIG. 22A is a partial view of the delivery catheter of FIGS. 20A-20E. [Figure 22B] 22B-22D show cross-sectional views of the delivery catheter taken in a plane perpendicular to the longitudinal axis of the delivery catheter shown in FIG. 22A. [Figure 22C] Same as above. [Figure 22D] Same as above. [Figure 23] FIG. 23 shows a schematic diagram of an exemplary two pull wire system for the delivery catheter shown in FIGS. 20A-20E. [Figure 24] FIG. 24 shows a side view of a sheath catheter. [Figure 25] FIG. 25 shows a cross-sectional schematic view of the sheath catheter shown in FIG. [Figure 26] FIG. 26 shows a cross-sectional view of the proximal portion of the sheath catheter. [Figure 27] FIG. 27 shows a cross-sectional view of a proximal portion of a portion of the sheath catheter shown in FIG. [Figure 28] FIG. 28 shows a cross-sectional view of the inner housing of the sheath catheter shown in FIG. [Figure 29] FIG. 29 shows a perspective view of the inner housing of the sheath catheter shown in FIG. [Figure 30] FIG. 30 shows a top view of the inner housing of the sheath catheter shown in FIG. [Figure 31] FIG. 31 shows an end view of the inner housing of the sheath catheter shown in FIG. [Figure 32] FIG. 32 shows a cross-sectional view of the inner housing of the sheath catheter. [Figure 33] FIG. 33 shows a cross-sectional view of the outer housing of the sheath catheter shown in FIG. [Figure 34] FIG. 34 shows a cross-sectional schematic view of a portion of the sheath of the sheath catheter shown in FIG. [Figure 35] FIG. 35 shows a cross-sectional schematic view of a portion of the sheath of the sheath catheter shown in FIG. [Figure 36] FIG. 36 shows a schematic cross-sectional view taken along line 36-36 in FIG. [Figure 37] FIG. 37 shows a schematic cross-sectional view taken along line 37-37 of FIG. [Figure 38] FIG. 38 shows a schematic diagram of a sheath catheter entering a patient's vasculature. [Figure 39] FIG. 39 is a cutaway 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 prosthetic heart valve delivery catheter. [Figure 40] FIG. 40 shows the heart valve of FIG. 39 further delivered to a patient's mitral valve by a prosthetic heart valve delivery catheter. [Figure 41] FIG. 41 shows a side view of the mandrel. [Figure 42] FIG. 42 shows a perspective view of a sheath positioned within the outer housing of a sheath catheter. [Figure 43] FIG. 43 shows a side cross-sectional view of the mandrel inserted into the sheath and outer housing of the sheath catheter. [Figure 44] FIG. 44 shows the inner housing inserted into the proximal opening of the outer housing. [Figure 45] FIG. 45 shows a perspective view of the proximal portion of the sheath catheter. DETAILED DESCRIPTION OF THE INVENTION

[0024] The following description and accompanying figures, which describe and illustrate specific embodiments, are intended to demonstrate, in a non-limiting manner, some possible configurations of systems, devices, instruments, components, methods, etc. that may 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 may 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. may be adapted for use in other valves outside of the mitral valve (e.g., in the tricuspid valve).

[0025] Described herein are embodiments of deployment tools and methods for using them that are intended to facilitate implantation of an implant, such as a prosthetic device (e.g., a prosthetic valve), in one of the native mitral, aortic, tricuspid, or pulmonary valve regions of a human heart. The prosthetic device or prosthetic heart valve may be an expandable transcatheter heart valve ("THV") (e.g., a balloon-expandable, self-expandable, and / or mechanically expandable THV). The deployment tools can be used to deploy implants in the form of anchoring devices (also referred to as docking devices, docking stations, or similar terms) that provide more stable docking sites for securing the prosthetic device or valve (e.g., THV) to the native valve region. These deployment tools can be used to more precisely position such anchoring devices (e.g., prosthetic anchoring devices, prosthetic valve anchoring devices, etc.) so that the anchoring devices and any prosthetic devices (e.g., prosthetic devices or prosthetic heart valves) secured thereto can function properly after implantation.

[0026] An example of one such anchoring device is shown in FIG. 2A. Other examples of anchoring devices that can be used herein are described in U.S. Patent Application Nos. 15 / 643,229, 15 / 684,836, and 15 / 682,287, each of which is incorporated herein by reference in its entirety. The anchoring devices herein may include a docking coil, may be coiled or helical, or may include one or more coiled or helical regions. Anchoring device 1 is shown in FIG. 2A as including two upper coils 10a, 10b and two lower coils 12a, 12b. In alternative embodiments, anchoring device 1 may include any suitable number of upper and lower coils. For example, anchoring device 1 may include one upper coil, two or more upper coils, three or more upper coils, four or more upper coils, five or more upper coils, etc. Furthermore, anchoring device 1 may have one lower coil, two or more lower coils, three or more lower coils, four or more lower coils, five or more lower coils, etc. In various embodiments, the anchoring device 1 can have the same number of upper coils as it has lower coils. In other embodiments, the anchoring device 1 can have more or fewer upper coils compared to the lower coils.

[0027] The anchoring device may include coils / turns of varying or the same diameter, coils / turns spaced apart with varying or no gap sizes, and coils / turns that taper, expand, or flare to become larger or smaller. Note that the coils / turns may also stretch radially outward when the prosthetic valve is deployed or expanded within the anchoring device 1.

[0028] In the illustrated embodiment of FIG. 2A , the upper coils 10 a, 10 b may be approximately the same size as the lower coils 12 a, 12 b or may have a slightly smaller diameter than the lower coils 12 a, 12 b. One or more lower end coils / turns (e.g., full or partial end coils / turns) may have a larger diameter or a larger radius of curvature than the other coils and can function as surrounding coils / turns to help guide the ends of the coils out and around the valve leaflets and / or any chordae, e.g., to encircle and surround the leaflets and / or any chordae. One or more larger diameter or larger radius lower or surrounding coils may allow for easier engagement with the native valve annulus and guidance around the native valve anatomy during insertion.

[0029] In some embodiments, one or more upper coils / turns (e.g., full or partial coils / turns) may be or have a larger diameter (or radius of curvature) and act as stabilizing coils (e.g., in the atrium) to help hold the coils in place before the prosthetic valve is deployed therein. In some embodiments, one or more upper coils / turns may be atrial coils / turns and may have a larger diameter than the coils in the ventricle, for example, to act as stabilizing coils / turns configured to engage the atrial wall for stability.

[0030] Some of the coils may be functional coils (e.g., coils / rotations between the stabilizing coil(s) / rotation(s) and the surrounding coil(s) / rotation(s)) that help hold each other in place when the prosthetic valve is deployed and the forces between the functional coils and the prosthetic valve help hold each other in place. The anchoring device and prosthetic valve may sandwich native tissue (e.g., valve leaflets and / or tendons) between themselves (e.g., between the functional coils of the anchoring device and the outer surface of the prosthetic valve) to more securely hold them in place.

[0031] In one embodiment, this may be the same as or similar to the anchor device shown in Figures 9I-9U, where the anchor device has one large upper coil / turn or stabilizing coil / turn, one lower end coil / turn or surrounding coil / turn, and multiple functional coils / turns (e.g., 2, 3, 4, 5, or more functional coils / turns).

[0032] When used in the mitral valve position, an anchoring device in the form of a docking coil can be implanted such that one or more upper coils / turns (e.g., upper coils 10a, 10b) are superior, i.e., on the atrial side of the native valve annulus (e.g., mitral valve 50 or tricuspid valve), and the lower coils 12a, 12b are inferior, i.e., on the ventricular side of the native valve annulus, as shown, for example, in FIG. 2C. 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 prevent movement due to cardiac motion.

[0033] FIG. 2B illustrates a generic delivery device 2 for placing an anchoring device in the annulus 50 of a native mitral valve using a transseptal technique. The same or similar delivery device 2 can be used to deliver an anchoring device 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 includes a flexible delivery catheter 24. The sheath 20 has a shaft in the form of an elongated hollow tube through which the delivery catheter 24 and various other components (e.g., anchoring devices and implants such as prosthetic heart valves) can be passed, thereby introducing the components into the patient's heart 5. The sheath 20 is steerable, allowing it to bend at various angles necessary for it to pass through the heart 5 and enter the left atrium 51. While within the sheath 20, the delivery catheter 24 is in a relatively straight or straight configuration (compared to a curved configuration, discussed in more detail below), e.g., the delivery catheter 24 is held within the sheath 20 in a configuration or shape that corresponds to the configuration or shape of the sheath 20.

[0034] Like sheath 20, delivery catheter 24 has a shaft in the shape of an elongated hollow tube. However, delivery catheter 24 has a smaller diameter than sheath 20 so that delivery catheter 24 is axially slidable within sheath 20. Meanwhile, delivery catheter 24 is large enough to accommodate and deploy an anchoring device, such as anchoring device 1.

[0035] The flexible delivery catheter 24 also has a flexible distal section 25. The distal section 25 can be bent into a configuration that allows for more precise placement of the anchoring device 1 and should generally have a robust design that allows the distal section 25 to bend and hold in such a configuration. For example, as shown in FIG. 2B , the flexible distal section 25 may be bent into a curved configuration in which the distal section 25 curves to aid in pushing or ejecting the anchoring device 1 from the ventricular side of the mitral valve 50 so that the lower coils (e.g., functional coil and / or surrounding coil) of the anchoring device 1 can be properly positioned below the native valve annulus. The flexible distal section 25 may be bent into the same or different curved configurations so that the upper coil(s) of the anchoring device (e.g., stabilizing coil / rotation or upper coils 10a, 10b) can be precisely deployed on the atrial side of the native valve annulus. For example, the flexible distal section 25 can have the same configuration used to place the upper coils 10a, 10b as that used to place the lower coils 12a, 12b. In other embodiments, the flexible distal section 25 can have one configuration to place the lower coils 12a, 12b and another configuration to place the upper coils 10a, 10b. For example, the flexible distal section 25 can be translated axially posteriorly from the above-described position to release the lower coils 12a, 12b and release and position the upper coils 10a, 10b on the atrial side of the native valve annulus.

[0036] In use, when using a transseptal delivery method to access the mitral valve, the sheath 20 can be inserted through the femoral vein, through the inferior vena cava 57, and into the right atrium 56. Alternatively, the sheath 20 can 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 is advanced into the left atrium 51, as can be seen in FIG. 2B. (For tricuspid valve procedures, it is not necessary to pierce or cross the septum 55.) The sheath 20 has a distal end portion 21, which may be steerable or pre-curved to facilitate maneuvering the sheath 20 into the desired chamber of the heart (e.g., the left atrium 51).

[0037] In a mitral valve procedure, the sheath 20 is in place in the left atrium 51 and the delivery catheter 24 is advanced from the distal end 21 of the sheath 20 so that the distal section 25 of the delivery catheter 24 is also within the left atrium 51. In this position, the distal section 25 of the delivery catheter 24 bends or curves into one or more curved or actuated configuration(s) so that the anchoring device 1 can be deployed in the annulus of the mitral valve 50. The anchoring device 1 can then be advanced through the delivery catheter 24 and deployed in the mitral valve 50. The anchoring device 1 can be attached to a pusher that advances or pushes the anchoring device 1 through the delivery catheter 24 for implantation. The pusher can be a wire or tube having sufficient strength and physical properties to push the anchoring device 1 through the delivery catheter 24. In some embodiments, the pusher may be made of or include a spring or coil (e.g., see flexible tubing 87, 97 in Figures 17A-18C below), a tubular extrusion, a braided tube, or a laser-cut hypotube, among other structures. In some embodiments, the pusher may have a coating thereon and / or therein, e.g., a PTFE-coated inner lumen to allow a thread (e.g., a suture) to be atraumatically actuated through the coated lumen. As described above, in some embodiments, after the pusher has pushed and properly positioned the ventricular coil of anchoring device 1 within the left ventricle, distal section 25 may translate axially rearward, e.g., to eject the atrial coil of anchoring device 1 into the left atrium while maintaining or retaining the position of the ventricular coil of anchoring device 1 within the left ventricle.

[0038] Once anchoring device 1 is deployed, delivery catheter 24 is removed by straightening or reducing the curvature of flexible distal section 25, allowing delivery catheter 24 to pass back through sheath 20. Once delivery catheter 24 is removed, a prosthetic valve, e.g., a prosthetic transcatheter heart valve (THV) 60, can then be passed through sheath 20 and secured within anchoring device 1, as shown, for example, in FIG. 2C . Once THV 60 is secured within anchoring device 1, sheath 20, along with any other delivery devices for THV 60, can be removed from the patient's body, closing off the patient's septum 55 and right femoral vein opening. In other embodiments, after anchoring device 1 is implanted, THV 60 can be delivered using a different sheath or a different delivery device, all separately. For example, a guidewire can be introduced through sheath 20, or sheath 20 can be removed and a guidewire can be advanced using a separate delivery catheter through the same access point, through the native mitral valve, and into the left ventricle. However, although in this embodiment the anchoring device is implanted transseptally, it is not limited to transseptal implantation, and delivery of the THV 60 is not limited to transseptal delivery (or more generally, via the same access point as the delivery of the anchoring device). In still other embodiments, after transseptal delivery of the anchoring device 1, 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.

[0039] FIG. 3A shows a perspective view of an exemplary distal section 25 that can be used in a delivery catheter 24. The distal section includes two opposite ends, two opposite sides 26 and 27, a top 28, and a bottom 29 extending between the two ends. These are displayed for ease of illustration and understanding and are not intended to limit the orientation of the distal section 25. The distal section 25 in FIG. 3A forms a generally cylindrical hollow tube that may include multiple links 38. Each link 38 has the shape of a cylindrical segment, and each link 38 aligns with and connects to adjacent links 38 to form the cylindrical tubular shape of the distal section 25. In this embodiment, the distal section 25 is cylindrical, although other shapes, such as an elliptical distal section, are also possible. Each link 38 of the distal section 25 may have a greater width at the bottom 29 than at the top 28, giving the link 38 an overall trapezoidal shape with acute angles when viewed from the side, as best seen in FIG. 3B. The bottom of each link 38 may have a slit 39 that allows for further bending of the links 38 relative to one another.

[0040] The distal section 25 may include a dual guide pattern that forms a hybrid bending section incorporating both side teeth 31, 32 and top teeth 33. To this effect, each link 38 may include two side teeth 31, 32 and two top teeth 33 on opposite sides of the link 38. With respect to the distal section 25, the two rows of side teeth 31, 32 of the link 38 may extend the length of the sides 26, 27 of the distal section 25, respectively, and the top teeth 33 may extend the length of the distal section 25 on the top 28, as best seen in FIG. 3A. While the rows of side teeth 31, 32 and top teeth 33 are shown as extending straight along the length of the distal section 25 in this illustrated embodiment, other embodiments may have different configurations. For example, in some embodiments, the rows of side teeth 31, 32 and top teeth 33 may spiral around the tube of the distal section 25, as shown, for example, in FIG. 4, to create a particular bending shape for the distal section 25 as the distal section 25 is actuated. In certain embodiments, the lateral teeth 31, 32 may be mirror images of one another, allowing for similar bending on both sides 26, 27 of the distal section 25. In other embodiments, the lateral teeth 31, 32 may have different shapes and / or sizes compared to one another. The teeth 31, 32, 33 may take on any other suitable shapes and / or sizes that allow the distal section 25 to be moved into a bent configuration while delivering the anchoring device. While the teeth 31, 32, 33 are all right-facing in the illustrated embodiment (e.g., oriented to the right in the view shown in FIG. 3B), in other embodiments, the teeth may be left-facing (e.g., see FIG. 4), or the top and lateral teeth may face in different directions.

[0041] Adjacent to each side tooth 31, 32 and each top tooth 33 is a corresponding side slot or groove 34, 35 and top slot or groove 36, respectively, on the adjacent link 38. Each slot 34, 35, 36 may have a shape complementary to the side tooth 31, 32 or top tooth 33 to which it is adjacent. When the distal section 25 is in a straight configuration, the side teeth 31, 32 are partially inserted into the side slots 34, 35, and the top teeth 33 are separated from their adjacent top slots 36 by a gap. Having the side teeth 31, 32 partially within the side slots 34, 35 in this straight configuration provides additional torque resistance to the distal section 25 of the delivery catheter 24 when the distal section 25 is not fully bent. However, in other embodiments, the side teeth 31, 32 may not be positioned partially within the side slots 34, 35 when the distal section 25 is in a straight configuration.

[0042] As distal section 25 is bent, each side tooth 31, 32 moves further into its corresponding side slot 34, 35, and each upper tooth 33 moves closer to and then into its corresponding upper slot 36. The addition of upper teeth 33 and upper slots 36 provides enhanced torqueability and torque resistance to distal section 25 when in the fully bent configuration. Furthermore, having both side teeth 31, 32 and upper teeth 33 provides additional guidance control and structural support when adjusting distal section 25 from its straight configuration to its bent configuration.

[0043] FIG. 3B is a detailed cross-sectional view of several links 38 of the distal section 25 of FIG. 3A. While FIG. 3B is described with respect to the lateral teeth 32, this description applies equally to the lateral teeth 31 on the opposite side of the distal section 25. The lateral teeth 32 are shown positioned along a lower tooth row 40 relative to the upper portion 28 of the distal section 25. This positioning allows the lateral teeth 32 to have less displacement, i.e., the distance the lateral teeth 32 move into the adjacent slot 35 is much shorter, or smaller, than if the lateral teeth 32 were positioned closer to the upper portion 28 of the distal section 25. For example, in the illustrated embodiment, the distance the lateral teeth 31, 32 move during bending is smaller compared to the distance the upper tooth 33 moves. In other words, the upper tooth 33 moves a greater distance relative to the adjacent link 38 when the distal section 25 is adjusted to a fully bent configuration compared to the lateral teeth 31, 32. This arrangement allows for the use of shorter lateral teeth 31 , 32 (eg, having lateral teeth with a shorter longitudinal length), which can then be incorporated into the shorter bending section of distal section 25 .

[0044] Additionally, the low tooth row also provides more space for the wider tooth slots 34, 35 to accommodate even larger side teeth, for example, because the tooth slots 34, 35 are located in a wider lower portion of the link 38. Having more space to accommodate larger and / or more suitable or robust tooth slots 34, 35 for the side teeth 31, 32 can enhance guidance of the teeth 31, 32 into the slots 34, 35, for example, during bending. The low tooth row also allows for the robust tooth design described above to provide structural support while bending the links away from each other, i.e., in the opposite direction of the bending configuration. Thus, when bending the links away from each other, the side teeth can maintain their interface with the adjacent side slot, and this maintained tooth-slot interface can provide more structural support and torque capability.

[0045] FIG. 4 is a perspective view of a distal section 25′ in a bent configuration according to a modification of the first embodiment. The distal section 25′ of FIG. 4 is similar to the distal section 25 of FIG. 3A, except that the rows of upper teeth 33′ and side teeth 31′, 32′ are shifted laterally around the tube-shaped distal section 25′ instead of continuing in a straight line down the length of the distal section. This positioning of the rows of teeth 31′, 32′, 33′ along, for example, a helical line, causes the distal section 25′ to bend in three dimensions, rather than in a single plane as occurs in FIG. 3A. As shown in FIG. 4, the exemplary distal section 25′ has a three-dimensional curved shape. Various embodiments of the distal section can be laser cut (e.g., into a sheet or tube) so that the upper teeth and side teeth follow a pattern that forms a desired shape during bending. For example, a pattern can be cut that creates a distal section with a curved shape that allows the distal section to be positioned at the mitral or other valve so that, when used in a surgical procedure, an anchoring device can be advanced from the distal section and precisely positioned at the valve.

[0046] The distal section 25, 25' can be manufactured, for example, by laser cutting a flat metal strip or sheet in the desired pattern and then rolling the patterned metal strip or sheet into a hypotube. Alternatively, the desired pattern (e.g., the same or similar to the patterns shown in the various figures herein) can be cut directly into the tube (e.g., hypotube) without using a sheet or rolling the material. As an example, FIG. 5 shows a top view of an exemplary laser-cut file or sheet 30 that can be used for the distal section 25 of FIG. 3A. This laser-cut sheet 30 includes both the upper teeth 33 and their associated slots 36, as well as the side teeth 31, 32 and their associated slots 34, 35 arranged in linear rows along the length of the distal section 25. However, as mentioned above, this laser cut file 30 may be modified to have teeth 31, 32, 33 and their associated slots 34, 35, 36 arranged in other different paths or configurations, for example, in a helical array, to create a curved or spirally bent distal section 25' similar to that shown in Figure 4. In other embodiments, various patterns can be cut that provide a distal section that can be bent in other shapes or configurations to aid in precisely navigating and deploying the anchor device to an implant site location during surgery.

[0047] Many types of sheets can be used that can be folded into a tube to create the cut distal section. Additionally, many types of tubes can be cut into the desired pattern(s). For example, Nitinol and stainless steel can be used as sheet or tube materials, as well as various other suitable metals known in the art.

[0048] While the above embodiment includes both top and side teeth so that each link 38 has a total of three teeth, other embodiments may include only top or side teeth, or no teeth at all.

[0049] 6 is a plan view of another exemplary laser-cut sheet 30'' for a distal section 25' of a delivery catheter. The distal section 25'' of FIG. 6 is similar to the distal section 25 of FIG. 5, except that the link 38'' of the distal section 25'' includes only two side teeth 31, 32 and their associated slots 34, 35, and does not include any top teeth or corresponding slots.

[0050] Figure 7 is a plan view of another exemplary laser-cut sheet 30''' for a distal section 25''' of a delivery catheter. The distal section 25''' of Figure 7 is also similar to the distal section 25 of Figure 5, except that each link 38''' of the distal section 25''' includes only a single upper tooth 33 and its associated slot 36, and does not include any side teeth or corresponding slots.

[0051] In other embodiments, each link can include more or less than three teeth in any combination. While Figures 6 and 7 are shown with teeth arranged linearly along the length of distal sections 25", 25'", respectively, laser-cut sheets 30", 30'" may be modified to include various tooth patterns and arrangements to have distal sections that can be bent to a particular desired shape, similar to the above.

[0052] Various sheath and catheter designs can be used to effectively deploy the anchoring device at the implant site. For example, the delivery catheter can 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 invention described below are configured to position the distal opening of the delivery catheter at the commissure A3P3 of the mitral valve, in other embodiments, the delivery catheter can instead approach the mitral face to face the commissure A1P1 and advance the anchoring device through the commissure A1P1. Furthermore, 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 anchoring device can be implanted or inserted in a right- or counterclockwise direction (e.g., the coil / rotation of the anchoring device can be rotated clockwise or counterclockwise depending on how the anchoring device is implanted).

[0053] In still further embodiments, the catheter itself may be positioned to pass below the plane of the native valve annulus and rest at or extend into the ventricle (e.g., through one of the commissures). In some examples, the distal end of the catheter may be used to capture and / or encircle some or all of the chordae tendineae 62. The catheter may be positioned in any suitable manner that allows the anchoring device to be deployed at the implant site. In some examples, the catheter itself may have an atraumatic tip design to provide atraumatic access to the implant site, for example, by reducing or eliminating damage that may occur from advancement and / or shape manipulation of the catheter while it is positioned at the implant site.

[0054] While some of the above-described embodiments for the distal portion of the delivery catheter include teeth and corresponding slots, other embodiments for the distal section may not include teeth and corresponding slots. FIG. 19 is a perspective view of another exemplary distal section 25'''' that may be used in a delivery catheter. In this embodiment, the distal section 25'''' is a solid, generally cylindrical, hollow tube made from a flexible material. The flexible material may be, for example, nitinol, steel, and / or plastic, or any other suitable material or combination of materials that allows the distal section 25'''' to move into a bent configuration during delivery of the anchoring device. While the illustrated embodiment shows the distal section 25'''' as a generally cylindrical tube, it should be understood that in alternative embodiments, the shape of the distal section 25'''' can take any suitable form that allows for delivery of the anchoring device. Some embodiments of the distal section may include linear slits and / or rectangular windows.

[0055] FIG. 8 shows a perspective view of a curved or “hockey stick” configuration of the distal section 65 of the delivery catheter 64. This configuration can be used to implant an anchor device into a native valve (e.g., a native mitral valve using a transseptal technique). In the “hockey stick” configuration, the distal end 65 of the delivery catheter 64 extending from the transseptal sheath 20 has four main subsections: a first curved section forming a shallowly curved portion 66, a second curved section forming a circular or curved flat portion 67, a turn 68, and a flexible end 69. The shapes of these subsections enable the distal section 65 to navigate the delivery catheter 64 to the location of the native valve (e.g., the native mitral valve) and precisely place the anchor device into the native valve (e.g., at the location of the mitral valve). The distal section 65 can take any suitable form that allows the distal section to assume the curved configuration described above, such as any of the forms described herein. In the illustrated embodiment, the distal section 65 of the delivery catheter 64 is curved in a clockwise direction, although in other embodiments (e.g., as seen in the embodiment of Figures 9A-9U), the distal section 65 can instead be curved in the opposite counterclockwise direction, e.g., with a circular / curved planar portion 67 and / or turn 68.

[0056] 9A-9U illustrate another exemplary embodiment of a delivery device (which may be the same as or similar to other anchoring devices described herein) for delivering and implanting an implant in the form of an anchoring device (which may be the same as or similar to other anchoring devices described herein) at a patient's native valve (e.g., at a patient's native mitral valve 50 using a transseptal technique). FIG. 9A is a cutaway view of the left atrium of a patient's heart showing the sheath 20 (e.g., a guide sheath or transseptal sheath) of a sheath catheter passing through the atrial septum and entering the left atrium, which may originate at the fossa ovalis (FO). FIG. 9B illustrates the transseptal sheath 20 and delivery catheter 64 in the position shown in FIG. 9A in a view looking down on the mitral valve 50 from the left atrium 51 (i.e., a view along line BB in FIG. 9A). Referring to FIG. 9A, the sheath 20 enters the left atrium such that the sheath is substantially parallel to the plane of the mitral valve 50. The sheath 20 and delivery catheter 64 can take any suitable form, such as, for example, any of the forms described in this application.

[0057] In some embodiments, the sheath 20 is actuable or steerable so that it is positioned or bent until it makes a certain angle (e.g., a 30-degree angle or approximately a 30-degree angle) relative 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 to better control the direction in which the delivery catheter 64 enters the left atrium. In other embodiments, the deflection angle of the sheath 20 relative to the septum and / or FO may be either more than 30 degrees or less than 30 degrees, depending on the circumstances, and in some applications may be oriented at or bent to make a 90-degree angle relative 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, for example, from about 5 degrees to about 80 degrees, for example, from about 10 degrees to about 70 degrees, for example, from about 15 degrees to about 60 degrees, for example, from about 20 degrees to about 50 degrees, for example, from about 25 degrees to about 40 degrees, for example, from about 27 degrees to about 33 degrees, etc.

[0058] 9C-9D, after the outer or guide sheath 20 has passed through the septum and / or FO and is positioned at the desired location, the delivery catheter 64 extends out of the sheath 20. The delivery catheter is controlled so that it includes a distal end 65 having a circular or curved, flat portion 67. In the illustrated embodiment, the distal end 65 of the delivery catheter 64 is moved such that the distal end 65 curves in a counterclockwise direction to create the circular / curved, flat portion 67 (the anchoring device can also be coiled in a counterclockwise direction). In alternative embodiments, the distal end 65 is moved such that the distal end 65 curves in a clockwise direction to create the circular / curved, flat portion 67 (the anchoring device can also be coiled in a clockwise direction in these embodiments).

[0059] 9E-9F, the delivery catheter 64 is also extended downwardly by a shallowly curved portion 66 at the distal end 65. As shown in FIG. 9E, the delivery catheter 64 is extended downwardly until the rounded / curved, flat portion 67 at the distal end 65 approaches the plane of the mitral valve 50, which is generally 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 64 is configured to extend 60 mm or less from the outer sheath, e.g., 50 mm or less, e.g., 45 mm or less, e.g., 40 mm or less, e.g., 35 mm or less, e.g., 30 mm or less, e.g., 25 mm or less, e.g., 20 mm or less. In some examples, the maximum extension of the delivery catheter 64 from the outer sheath is about 20 mm to about 60 mm, e.g., about 25 mm to about 50 mm, e.g., 30 mm to about 40 mm. In certain embodiments, the delivery catheter 64 can be moved into any of the various configurations described herein by engaging one or more actuation points 70, 71 of the delivery catheter 64.

[0060] The rounded / curved planar portion 67 is advanced or lowered to lie near, above, or substantially above the plane of the mitral valve 50. Once lowered to or near the level of the annulus, the planar portion 67 or the plane of the planar portion 67 may be parallel or nearly parallel (e.g., flat or nearly flat) to the plane of the annulus, or the planar portion 67 may be angled slightly upward relative to the plane of the annulus. The delivery catheter 64 also curves to circle its return path toward the commissure A3P3. The delivery catheter 64 can be moved to create the rounded / curved planar portion 67 and / or the shallowly curved portion 66 by any suitable means, such as, for example, a pull wire and ring system, or any other suitable means, including those described elsewhere in this application. Although the illustrated embodiment shows distal end 65 moving to create circular or curved planar portion 67 before distal end 65 moving to create shallow curved portion 66, it should be understood that the downward extension of distal end 65 to create shallow curved portion 66 can occur before distal end 65 curves in a counterclockwise direction to create circular or curved planar portion 67.

[0061] 9G-9H, actuation point 70 (and / or one or more other actuation points) can be located between shallow curved portion 66 and circular / curved flat portion 67, which allows adjustment of distal section 65. In the illustrated embodiment, actuation point 70 can be adjusted to angle flat portion 67 and flexible end 69 slightly downward such that flexible end 69 and distal tip 907 extend below the annulus (or below the superior plane of the annulus) toward and / or into commissure A3P3 of mitral valve 50. That is, first actuation point 70 can be actuated such that flat portion 67 (and, consequently, flexible end 69) is angled downward toward commissure A3P3 and positioned at or near (e.g., slightly in or through, such as 1-5 mm or less) the commissure. Additionally or alternatively, for further actuation point 70, the delivery device (e.g., sheath and / or delivery catheter) can be twisted or rotated to angle the circular / curved planar portion 67 toward and / or into the commissure as desired. This twisting or rotation may sometimes be necessary to get the angle correct if actuation of the curved portion does not fully position the distal region of the catheter as desired. In some embodiments, second actuation point 71 may be located between portion 67 and flexible end 69.

[0062] 91 shows a delivery catheter 64 deploying an exemplary embodiment of anchoring device 1 through the commissures A3P3 and around the chordae tendineae 62 and native valve leaflets within the left ventricle 52 of the patient's heart. The anchoring device 1, or the lower end or surrounding coil / turn of an anchoring device having a larger diameter or radius of curvature, exits the distal opening of delivery catheter 64 and begins to assume its shape-set or shape-memory configuration toward the circular or curved planar portion 67 of delivery catheter 64.

[0063] To move anchoring device 1 through the commissure A3P3 of mitral valve 50, delivery catheter 64 is positioned so that the circular / curved, planar portion 67 and the distal opening of flexible end 69 of delivery catheter 64 are angled downward, with the distal opening of flexible end 69 pointing toward and / or into commissure A3P3. As a result of the circular / curved, planar portion 67 and the distal opening of flexible end 69 facing downward, anchoring device 1 exits delivery catheter 64 downward. After anchoring device 1 exits delivery catheter 64, anchoring device 1 begins to curve and assume its shape-set or shape-memory configuration. Because the circular / curved, planar portion is angled downward, anchoring device 1 begins to curve upward after approximately one-half turn of the anchoring device has been deployed, as shown in FIG. 9I. To prevent the anchoring device 1 or the lower end / surrounding coils / turns from engaging the mitral valve 50 upward as it is delivered from the delivery catheter 64, once the anchoring device begins to wrap around the chordae 62 (as shown in FIG. 9I), the delivery catheter 64 can be moved (e.g., by moving at actuation point 70) so that the circular / curved planar portion 67 is substantially parallel to the plane of the mitral valve 50 (see FIG. 9L). This can be done by actuating at point 70 and / or twisting or rotating the delivery device or a portion thereof (e.g., the delivery catheter) to adjust the angle of the planar portion 67 as desired.

[0064] 9J, after the circular / curved planar portion 67 has been moved so that it is substantially planar with the mitral valve annulus, the anchoring device 1 may be further deployed from the delivery catheter 64, such that the anchoring device wraps around the chordae tendineae 62 in a position substantially parallel to the plane of the mitral valve 50. This prevents the anchoring device from bending upward and engaging the underside of the mitral valve annulus and / or the upper wall of the left ventricle.

[0065] 9K, anchoring device 1 is positioned around 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, anchoring device 1 is positioned within left ventricle 52 so that the anchoring device's three functional coils 12 are tightly wrapped around the chordae tendineae and / or native valve leaflets. The lower end turn / coil, or surrounding turn / coil, can be seen to extend somewhat outward due to its larger radius of curvature. In some embodiments, anchoring device 1 may include fewer than three coils 12 or four or more coils 12 positioned around the chordae tendineae and / or valve leaflets.

[0066] 9L shows the delivery catheter 64 in position within the left atrium 51 after the coil 12 of the anchoring device has been positioned around the chordae tendineae 62 and native valve leaflets (as shown in FIG. 9K). In this position, the circular / curved planar portion 67 of the delivery catheter 64 is substantially parallel to the plane of the mitral valve 50, and the flexible end 69 is located at or near the commissure A3P3 of the mitral valve 50 (e.g., extending slightly into or through the mitral valve, e.g., 1-5 mm or less).

[0067] 9M, with the delivery catheter 64 and anchoring device 1 positioned as shown in FIGS. 9K-9L, the delivery catheter is translated or retracted axially in the X direction along the anchoring device and into the outer sheath 20. The translation or retraction of the delivery catheter unsheathes and releases the portion of the anchoring device positioned on the atrial side of the native valve (e.g., in the atrium) from the delivery catheter. For example, this can unsheath 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 1 does not move, or substantially does not move, as the delivery catheter is translated, e.g., a pusher can be used to hold the anchoring device in place and / or inhibit or prevent retraction of the anchoring device as the delivery catheter is retracted.

[0068] Referring to FIG. 9N, in the illustrated example, translation or retraction of the delivery catheter can also unsheath / release any upper end coils / turns 1a (e.g., larger diameter stabilization coils / turns) of the anchoring device 1 from the delivery catheter. As a result of the unsheathing / release, the atrial side of the anchoring device or upper coils (e.g., stabilization coils with a larger diameter or radius of curvature) extends from the delivery catheter 64 and begins to assume its pre-set or relaxed shape-set / shape-memory shape. The anchoring device may also include an upwardly extending or connecting portion extending upward from the bend Z and extending and / or bridging between the upper end stabilization coils / turns and other coils / turns of the anchoring device (e.g., functional coils / turns). 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.

[0069] 9O, the delivery catheter 64 continues back into the outer or guide sheath 20, thereby releasing the upper portion of the anchoring device 1 from within the delivery catheter. The anchoring device is tightly connected to the pusher 950 by an attachment means such as a suture / thread 901 (or other attachment or connection means that may be used, such as in FIGS. 17A-18C). An upper end coil / turn 1 a or stabilizing coil / turn is shown positioned along the atrial wall to temporarily and / or loosely hold the position or height of the anchoring device 1 relative to the mitral valve 50.

[0070] 9P, anchoring device 1 is completely removed from the lumen of delivery catheter 64, and the slack is taken up by a suture / thread 901 removably attached to anchoring device 1, e.g., suture / thread 901 can be looped through a hole at the end of the anchoring device. To remove anchoring device 1 from delivery catheter 64, suture 901 is removed from the anchoring device. However, before suture 901 is removed, the position of anchoring device 1 can be checked. If the position of anchoring device 1 is incorrect, the anchoring device can be pulled back into the delivery catheter by pusher 950 (e.g., a pusher rod, pusher wire, pusher tube, etc.) and redeployed.

[0071] 9Q, after the delivery catheter 64 and outer sheath 20 have been detached from the anchoring device 1, 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 of the components of the delivery catheter 64 and / or the outer or guide sheath 20, or the delivery device 902 may be separate from the delivery catheter 64 and outer or guide sheath. In the illustrated embodiment, the heart valve delivery device 902 enters the left atrium 51 using a transseptal approach. In embodiments, the heart valve delivery catheter 902 may pass through the outer sheath 20. Such a configuration is shown, for example, in FIGS. 39 and 40 .

[0072] 9R, a heart valve delivery device / catheter 902 is moved through the mitral valve 50 such that the heart valve 903 is positioned between the mitral valve leaflets and the anchoring device 1. The heart valve 903 can be guided along a guidewire 904 to a deployment position.

[0073] 9S, after the heart valve 903 is positioned at the desired location, 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 with the leaflets of the mitral valve 50 and forces the ventricle outward to its increased size, securing the leaflets between the heart valve 903 and the anchoring device. The outward force of the heart valve 903 and the inward force of the coil 1 can pinch the native tissue to hold the heart valve 903 and the coil to the leaflets. In some embodiments, a 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, thereby expanding 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 expand by a combination of self-expansion and mechanical expansion).

[0074] 9T, after the heart valve 903 has been moved to its expanded state, the heart valve delivery device 902 and wire 904 (still shown in FIG. 9T) are removed from the patient's heart. Additionally, the guide sheath 20 may also be removed from the patient's heart. The heart valve 903 is now in a functional state and replaces the function of the mitral valve 50 of the patient's heart.

[0075] FIG. 9U shows the heart valve 903 from a top view of the left ventricle 52 along line UU in FIG. 9T. In FIG. 9U, 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., valve 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, such as two or more valve members, three or more valve members, or four or more valve members. In the illustrated embodiment, the valve members 905a-c are shown in a closed position, which is the position the valve members are in during systole to prevent blood from moving from the left ventricle to the left atrium. During diastole, the valve members 905a-c move to an open position, allowing blood to enter the left ventricle from the left atrium.

[0076] 9A-9U show delivery catheter 64 delivering anchoring device 1 through commissure A3P3, it should be understood that delivery device 64 can be configured and positioned in the left ventricle of a patient's heart to deliver anchoring device 1 through commissure A1P1 so that anchoring device 1 can be wrapped around the chordae tendineae. Furthermore, while the illustrated embodiment shows delivery catheter 64 delivering anchoring member 1 to mitral valve 50 and heart valve delivery device 902 delivering heart valve 903 to mitral valve 50, it should be understood that anchoring device 1 and heart valve 903 can be adapted, mutatis mutandis, to repair a tricuspid valve, an aortic valve, or a pulmonary valve.

[0077] In one embodiment, the distal section 65 of the delivery catheter 64 can be a solid, generally cylindrical hollow tube (eg, distal section 25'''' shown in FIG. 19).

[0078] The guide sheath and / or distal section of the various delivery catheters herein may include one or more pull wires (e.g., two to six pull wires) for controlling or actuating the delivery catheter into a desired configuration. For example, the distal section of the various delivery catheters herein may have a two-pull wire system (e.g., the two-pull wire system depicted in FIGS. 20A-23). ​​For example, the configuration depicted in FIGS. 9A-9U or the "hockey stick" configuration depicted in FIG. 8, or any other configuration described herein, may also be achieved by using a flexible tube catheter with two pull rings positioned at or near the actuation points 70, 71 discussed above. The pull rings may engage or connect to respective pull wires. The pull wires may be positioned circumferentially around the delivery catheter 90 degrees apart. For example, a first pull ring positioned approximately midway along the distal section 65 can be actuated by a first pull wire to pull the distal region of the delivery catheter toward the native valve plane (e.g., the mitral plane), while a second pull ring positioned further distally at or near the distal tip 907 of the delivery catheter can be actuated by another pull wire to curve the catheter in a different direction, for example, around the native valve plane (e.g., around the mitral plane) and toward a desired commissure (e.g., the mitral valve commissure A3P3), and further, if desired.

[0079] In some embodiments, the two pull rings can be connected by a spine mounted radially opposite one of the pull wires, e.g., on the opposite side of the pull wire for the most distal pull ring. Such an added spine can limit relative movement between the pull rings, help better control the direction of deflection caused by pulling the pull wire for the most distal pull ring, and prevent deflection of the flexible distal section perpendicular to the mitral plane or in an otherwise unintended direction. While the above-described embodiment may include three pull rings and two pull wires, it should be understood that any number of pull rings and / or pull wires can be used to create the various configurations described herein. Furthermore, it should be understood that any suitable number of spines can be used to limit relative movement between the pull rings.

[0080] In some embodiments, the distal section 65 may be a laser-cut hypotube (similar to the laser-cut catheters described in FIGS. 4-7 above) that is arranged in a pattern such that, when bent, the distal section forms any of the various configurations described herein (e.g., the configurations described in FIGS. 9A-9U, a "hockey stick" configuration, etc.). Also, as described, such a laser-cut distal section may have two or more actuation points that can be actuated independently of one another, e.g., with separate pull wires, controlled by separate controls (e.g., knobs, tabs, inputs, buttons, levers, switches, etc.) or separate mechanisms, to achieve bidirectional deflection of the distal end in a fully bent configuration (e.g., one bend toward the mitral plane and the other bend is a generally circular portion that bends around the mitral valve annulus).

[0081] In some embodiments, the entire distal section 65 need not be constructed as a laser-cut hypotube. For example, the distal section 65 may include a first flexible straight section proximal to the shallowly curved section 66, an optional small laser-cut elbow that makes up the shallowly curved section 66 to help bend the distal-most region of the catheter onto the mitral plane, and then a second flexible section extending to the distal tip that can bend along the mitral plane to direct the end of the catheter toward the A3P3 commissure. The first flexible section is flexible enough to allow the distal section 65 to land near the mitral plane after exiting the transseptal sheath 20 and be pushed and advanced through the sheath 20, yet is stiff enough to withstand being impacted by the anchoring device as it advances and is delivered through the catheter. The first flexible section can be constructed, for example, using polyether block amide (PEBAX) having a hardness of approximately 50D that is coated onto a coiled or braided tube. Meanwhile, the small laser-cut elbow portion can have a maximum deflection of approximately 150 degrees to assist in bringing the distal region of the catheter to the mitral plane. Finally, a second flexible section extends to the distal tip of the delivery catheter and may be configured to bend the catheter toward the A3P3 commissure, as previously discussed, and potentially further bend to assist in tendon encirclement by the anchoring device. The second flexible section may also be constructed, for example, using PEBAX having a hardness of approximately 55D, which is also reflowed onto a coiled or braided tube. This configuration can also result in a distal section 65 that can be shaped and actuated substantially similarly to the laser-cut hypotube described above, without the need to form the entire distal section 65 as a laser-cut hypotube or any portion from a laser-cut hypotube.

[0082] While the delivery catheter 64 having the distal section 65 has been described using the above-described embodiments, it should be understood that the above-described embodiments are exemplary only. The delivery catheter 64 can take any suitable form capable of producing the features described herein. Furthermore, the delivery catheter can be constructed using any suitable material capable of producing the features described herein.

[0083] FIG. 10 shows a perspective view of an exemplary distal section 75 of a delivery catheter 74 (which may be the same as or similar to other delivery catheters described herein) for implanting an anchoring device (which may be the same as or similar to other anchoring devices described herein) into a native valve. For the mitral valve, this can be done using a transseptal technique. The delivery catheter is shown assuming an example of a spiral configuration. Unlike the "hockey stick" configuration and similar to the configurations discussed in FIGS. 9A-9U, the sheath 20 extends through the FO in a direction parallel to the plane of the native valve annulus (e.g., the mitral plane). In this embodiment, the distal section 75 then exits the sheath 20 and extends approximately one spiral down to the commissures A3-P3 of the mitral valve. The distal section 75 may be configured in a spiral shape, such that the distal end of the catheter may initially extend below the plane of the native valve annulus during deployment. The user can then adjust the height of the distal tip, for example, by applying upward tension to a flex wire incorporated into or attached to the catheter to raise or bring the distal tip up to the plane of the annulus of the patient's heart's native valve.

[0084] In some embodiments, the distal section 75 may be entirely laser-cut hypotube (similar to the laser-cut catheter described in Figures 4-7 above), with the cuts arranged in a pattern such that the distal section forms a helical configuration when bent. In some embodiments, the helical configuration of the laser-cut hypotube is allowed to be shaped into a helix that extends or extends into the plane of the native valve annulus (e.g., extending or extending from the FO to a position lower than the mitral plane). The respective gaps between the upper teeth and their associated slots (e.g., the slots are radially wider than the teeth, providing space for the teeth to move radially when in their respective slots) allow for vertical extension of the catheter. The distal section can be shaped in this vertically extended configuration. The helix can then be positioned along or just above the mitral plane when the helix is ​​in the mitral valve anatomy by, for example, relaxing or tensioning the flex wires in the distal section of the catheter or otherwise attached to the distal section of the catheter, as previously described. This feature allows the helix to be adjusted to various heights to accommodate different patient anatomies.

[0085] In another embodiment employing a delivery catheter 74 in a helical configuration, the distal section 75 need not be constructed as a laser-cut hypotube, but instead can be formed as a coated coil. For example, the catheter can be formed from a braided or coiled tube with, for example, low-durometer PEBAX, having a hardness of approximately 55D, coated thereon. Upon bending, the catheter can create a helical configuration as described above. Alternatively, to control the height of the helix, a pusher wire can be included extending along the shaft of the delivery catheter and optionally connected to the distal end of the catheter. The pusher wire has sufficient strength and physical properties to allow the distal end of the catheter to be pushed and / or retracted onto the annular surface of the native valve (e.g., the mitral surface). For example, the pusher wire can be NiTi wire, steel, or any other suitable wire. In one embodiment, pushing the pusher wire lowers the distal end of the spiral, and when the distal end advances below the plane of the native valve annulus (e.g., below the mitral plane), pulling back on the pusher wire raises the distal end of the delivery catheter.

[0086] In another embodiment employing delivery catheter 74 in a spiral configuration, the distal section may not be laser cut or may not be cut at all (e.g., similar to distal section 25'''' shown in FIG. 19). For example, distal section 75 of delivery catheter 74 may be formed by a flexible tubular catheter constructed with pull rings, pull wires, and / or spines configured to move delivery catheter 74 into the spiral configuration.

[0087] While delivery catheter 74 having distal section 75 has been described using the above-described examples, it should be understood that the above-described examples are merely illustrative. Delivery catheter 74 can take any suitable form capable of creating a helical configuration. Furthermore, delivery catheter 74 can be constructed of any suitable material capable of creating a helical configuration (e.g., distal section 75 can take the form of delivery catheter 114 shown in FIGS. 20A-23).

[0088] FIG. 11 shows a perspective view of a hybrid configuration of the distal section 105 of the delivery catheter 104. The delivery catheter 104 combines features of both the "hockey stick" and spiral configurations described above. In the hybrid configuration, similar to the "hockey stick," the distal section 105 of the delivery catheter 104 initially has a shallowly curved or bent portion 106, bending the catheter 104 toward the mitral plane. In an alternative embodiment, the catheter 104 is bent by increasing the proximal bending of the bent portion 106. The shallowly curved portion may be followed by a circular or curved, flat portion 107 that begins to curve in a counterclockwise direction, as shown, for example. In other embodiments, the delivery catheter 104 may instead be bent or curved in a clockwise direction (e.g., as seen in FIG. 8). The flat portion 107 may be substantially parallel to the mitral plane.

[0089] Meanwhile, distal to the planar portion 107 is a flexible end 108 that can be bent, angled, or otherwise angled slightly downward from the plane in which the planar portion 107 is disposed to more effectively direct the distal opening of the delivery catheter 104 toward the commissure or other target. In some embodiments, the flexible end 108 can form a downward spiral region of the delivery catheter 104. The flexible end 108 can be deflected or displaced vertically from the planar portion 107 by about 2 mm to about 10 mm, e.g., about 3 mm to about 9 mm, e.g., about 4 mm to about 8 mm, e.g., about 5 mm to about 7 mm, e.g., about 6 mm. In other embodiments, the vertical displacement can be about 2 mm or more, e.g., about 3 mm or more, e.g., about 4 mm or more, e.g., about 5 mm or more, e.g., about 6 mm or more, e.g., about 7 mm or more, e.g., about 8 mm or more, e.g., about 9 mm or more, e.g., about 10 mm. Further, in some embodiments, the flexible end 108 (i.e., the downward spiral section) can begin at a substantially curved portion 106, such that substantially only a small portion, or none, of the distal section 105 of the delivery catheter 104 extends in a plane parallel to the mitral plane.

[0090] Similar to the delivery catheters described above, the distal section 105 of the delivery catheter 104 may be made of or include laser-cut hypotube, braided or coiled tubing catheter, uncut flexible tubing, or other flexible tubular structures. In some embodiments, the distal section 105 of the catheter 104 may be coated with, for example, PEBAX. Additionally, the distal end 105 of the delivery catheter 104 may be actuated or manipulated, for example, via shape setting, pull wires and / or pull rings, spines, and / or utilizing various other methods or features described herein.

[0091] While in the above-described embodiments, the delivery device is generally or mostly positioned above the annular plane of the native valve (e.g., the mitral plane), and the anchoring device is pushed out of the delivery device (e.g., 1-5 mm or less) while still on the atrial side or slightly beyond, and advanced into the ventricle (e.g., through the commissures of the native valve), in some other embodiments, at least a portion or a substantial portion of the delivery device itself may also be positioned within the left ventricle. For example, FIG. 12 shows a delivery device for placing anchoring device 1 in a native mitral valve using a transseptal technique, with the majority of the distal end of the delivery device itself (e.g., the curved or actuable portion) also advanced through the native mitral valve and into the left ventricle.

[0092] Referring to FIG. 12 , the delivery device shown includes a sheath catheter that includes an outer guide sheath 20. The delivery device includes a flexible delivery catheter 114 that can be advanced through and from the distal end of the guide sheath 20. In the embodiment shown, the guide sheath 20 can be first maneuvered into the left atrium, for example, through an opening formed in the interatrial septum (e.g., at the fossa ovalis), as seen in FIG. 12 . The guide sheath 20 can then be manipulated to curve or bend downward toward the native mitral valve annulus so that the distal opening of the guide sheath 20 is oriented approximately coaxially with the central axis of the mitral valve annulus. The vertical position of the guide sheath 20 can be such that the distal opening of the guide sheath 20 is positioned within the left atrium substantially aligned with or slightly superior to the native mitral valve annulus, or, in some embodiments (as shown in FIG. 12 ), may extend through the native mitral valve annulus into the left ventricle.

[0093] Once the guide sheath 20 is positioned substantially as shown in FIG. 12 , the delivery catheter 114 is then advanced from the distal opening of the guide sheath 20. In this embodiment, the distal end of the guide sheath 20 is positioned at or slightly above the native mitral valve annulus, such that the delivery catheter 114 can be initially advanced into the left atrium, just above the native mitral valve annulus. The delivery catheter 114 can initially be advanced from the distal opening of the guide sheath 20 in an unactuated, substantially straight configuration, and then, after advancing from the guide sheath 20, can be actuated into the bent configuration shown in FIG. 12 . In some embodiments, the delivery catheter 114 can be actuated into any other suitable configuration, such as, for example, any of the configurations described herein.

[0094] Flexible delivery catheter 114 may include two or more main deflectable sections, for example, a distal section 115 that is bendable into a curved configuration that is relatively wider and more circular in shape to assist in forming anchor device 1 when anchor device 1 is advanced from delivery catheter 114 and delivered to the implant site, and a more proximal section 116 that forms a sharper bend, for example, an approximately 90 degree bend, to assist in bringing distal section 115 into a plane that is substantially flush with or parallel to the annular plane of the native valve (e.g., the mitral plane). Delivery catheter 114 can take any suitable form, such as, for example, any of the forms described herein.

[0095] 13-16, in one exemplary embodiment, the distal region 117 of the exemplary delivery catheter 114 can be constructed from a hypotube having a first series of slots 125 and a second series of slots 126. The delivery catheter can also have a pullwire system (e.g., a two-pullwire system including a first pullwire 135 and a second pullwire 136). FIG. 13 shows a schematic side view of the distal section 117 of an exemplary embodiment of the delivery catheter 114. FIG. 14 shows a cross-sectional view of a multi-lumen extruded portion of the delivery catheter 114, taken along a plane perpendicular to the longitudinal axis of the delivery catheter, and FIGS. 15 and 16 show schematic perspective views of the delivery catheter 114 of FIG. 13 in a partially and fully actuated state, respectively. As shown in any of the above-described embodiments, other delivery catheters deployed and used in different ways can be constructed with a similar two-pullwire system.

[0096] In one embodiment, the delivery catheter 114 has a distal region 117 including two flexible sections 115, 116. A first series of slots 125 may be disposed (e.g., linearly arranged or otherwise) along a first side of the distal region 117 to correspond to and provide flexibility for the first flexible section 115, such that the first flexible section 115 may form a generally circular configuration (e.g., similar to that shown in FIG. 12 ) when the delivery catheter is actuated. A second series of slots 126 may be disposed linearly along a second side of the distal region 117 to correspond to and provide flexibility for the second flexible section 116, such that the second flexible section 116 may form a sharper bend, such as that shown in FIG. 12 , when the delivery catheter 114 is actuated. The slots 125, 126 may be laser cut or formed as discussed in the previous embodiment, or may be otherwise formed in a variety of other ways so long as the slots 125, 126 contribute to the desired shape of the delivery catheter 114 upon actuation. The second series of slots 126 is located slightly proximal to the first series of slots 125 corresponding to the bending locations of sections 115, 116 and may be circumferentially offset by, for example, about 90 degrees around the distal region 117 to allow for two orthogonal bends within the region, and the respective radii of curvature and directions of articulation of sections 115, 116 may differ from one another. In some embodiments, sections 115, 116 may be circumferentially offset by, for example, about 65 degrees to about 115 degrees, e.g., about 75 degrees to about 105 degrees, e.g., about 80 degrees to about 100 degrees, e.g., about 85 degrees to about 95 degrees, etc.

[0097] In certain embodiments, each of sections 115, 116 may have an associated pull wire 135, 136 for controlling the bending of sections 115, 116, respectively. Pull wire 135 may extend distally beyond slot 125 and may be attached to distal region 117, for example, via welding or other attachment means at connection point 135a and / or a pull ring. Similarly, pull wire 136 may extend distally beyond slot 126 and may be welded or otherwise attached to distal region 117 at connection point 136a and / or a pull ring.

[0098] Meanwhile, proximal to the distal region 117, the delivery catheter 114 may include a proximal section 140, which may be formed as a braided, multi-lumen tubular extrusion. As can be seen in cross-section in FIG. 14 , the proximal section 140 of the delivery catheter 114 may have one or more central lumens through which the pull wires 135, 136 extend to reach the distal region 117. The pull wires 135, 136 may be positioned to extend side-by-side through a central region of the proximal section 140 and then distally exit the proximal section 140 and attach to the sidewall of the distal region 117 as previously described. The central positioning of the pull wires 135, 136 through the proximal section 140 provides an anti-whipping or anti-bending effect through the delivery catheter 114, when the pull wires 135, 136 are used, allowing the delivery catheter 114 to maintain full torqueability. However, in some embodiments, the pull wire is not centrally located, but extends end-to-end along the side or outer wall.

[0099] Further, the proximal section 140 may have a main lumen 141. If the pull wire is not central, the main lumen can be centered. Optionally, the main lumen 141 may be offset from the center of the extrusion, for example, when the pull wire is centered. The main lumen 141 is sized sufficiently to allow the anchoring device to pass through and be delivered. The main lumen 141 may have, for example, an oval cross-section, a circular cross-section, or a cross-section having any other suitable shape, so long as the anchoring device 1 can be effectively advanced therethrough. In addition to the main lumen, several optional parallel dummy lumens may also be formed in and extend longitudinally through the proximal section 140, for example, to affect a symmetrical moment of inertia about the pull wire passing through the proximal section 140. In the illustrated embodiment, a first dummy lumen 142 is optionally positioned diametrically opposite the main delivery lumen 141 and is formed to be substantially the same shape as the main lumen 141 (e.g., oval in the illustrated embodiment). Additionally, two additional optional dummy lumens 143 are positioned diametrically opposite one another and circumferentially between lumens 141 and 142. Additional dummy lumen 143 is illustrated as being slightly smaller and having a more circular shape than lumens 141, 142. In practice, the size and shape of dummy lumen 143 may vary otherwise and is generally selected based on the respective sizes of lumens 141, 142 and the amount of space remaining in the extrusion. Furthermore, main lumen 141 and first dummy lumen 142 may have variable sizes and shapes, depending on the particular application. Furthermore, in some other embodiments, more or less than four total lumens may be formed in proximal section 140 to affect desired symmetry and moment of inertia around the pull wire extending through the central axis of proximal section 140, and to uniform stiffness.

[0100] 2B, 9A-9N, and 12, in practice, once guide sheath 20 is positioned as desired (e.g., as shown or described elsewhere herein), for example, a distal region of the delivery catheter, crossing the septum in a mitral valve procedure (e.g., distal region 117 or any of the other distal regions described herein), and in some embodiments, a portion of the proximal section (e.g., proximal section 140), advances from the distal opening of guide sheath 20. The portion of the delivery catheter (e.g., catheter 114) extending from guide sheath 20 may be positioned within the left atrium before the delivery catheter is adjusted to its actuated or final actuated configuration. In some cases, a portion of the delivery catheter may also extend through the native mitral valve into the left ventricle (e.g., as in FIG. 12, or only slightly, such as 1-5 mm or less) before the delivery catheter is adjusted to its actuated or final actuated configuration. The distal region 117 can then be actuated, and the pull wires 135, 136 can be tensioned to obtain two bends in sections 115, 116, e.g., at the distal portion of the delivery catheter 114. For example, as shown in FIG. 15 , in one sequence, the second pull wire 136 can first be tensioned to bend section 116 and bring the portion of the delivery catheter 114 distal to section 116 substantially planar and / or parallel to the native valve annulus. Next, as shown in FIG. 16 , the first pull wire 135 can be tensioned to bend section 115 to its rounded or curved actuated state such that the curvature of section 115 is substantially planar and / or parallel to the native valve annulus (e.g., with the mitral plane). In other embodiments, the pull wires 135, 136 can be partially or fully tensioned in different amounts and / or sequences to properly and safely navigate the patient's anatomy during actuation.For example, section 115 may be actuated and curved to form a circular or curved planar portion (e.g., similar to planar portion 67) before actuating or bending section 116 to a lower and / or curved planar portion or section 115 to an appropriate angle (e.g., as described with respect to FIG. 9 ). After these actuation steps, in one embodiment, distal region 117 of delivery catheter 114 may be positioned completely or nearly within the left atrium, or on the atrial side of the native valve.

[0101] In some situations, actuation of the curved region of the delivery catheter is not sufficient to properly position the distal tip at or near the commissure at the desired location for delivery; twisting or rotating the delivery device, or portions thereof (e.g., rotating the delivery catheter and / or guide sheath) can be used to angle the delivery catheter and the tip of the delivery catheter as desired. For example, after the distal region 117 of the delivery catheter 114 is fully actuated or curved as desired (e.g., as described above), the assembly can be twisted and rotated to angle or align the tip of the delivery catheter 114 at or with a commissure of a native valve, e.g., the commissure A3P3 of the mitral valve. The delivery catheter 114 can then be further twisted and rotated so that the distal tip of the delivery catheter 114 passes the commissure and enters the left ventricle. Optionally, further rotation and / or actuation of the delivery catheter 114 can then facilitate circumferential advancement of the distal tip of the delivery catheter 114 within the left ventricle to loop or position it around the outside of the mitral valve anatomy, such as the chordae tendineae, papillary muscles, and / or other features within the left ventricle. The centrally located design of the proximal section 140 and the pullwires 135, 136 helps to provide an anti-whipping or anti-bending effect through the delivery catheter 114 as the pullwires 135, 136 are manipulated, allowing the full torqueability of the delivery catheter 114 to be maintained through transseptal bending and facilitating the distal region 117 to more effectively retain and maintain its working configuration during this rotation step.

[0102] 12 , if the user elects to move the distal region of the catheter into a cardiac chamber (e.g., the left or right ventricle), moving the delivery catheter 114 around the anatomical structures within the chamber can help to collect or capture the enclosed anatomical structures within the curvature of the distal region 117. In some embodiments, after the distal region 117 of the delivery catheter 114 has been moved to a desired position around the tendons and other features within the chamber, the first pull wire 135 can remain further tensioned to reduce the radius of curvature of the rounded section 115 and pass through the center of the rounded section 115 further toward the center of the native annulus to cinch and gather the tendons and other native anatomical structures. Such radial cinching or gathering of the native anatomical structures in the chamber can help to facilitate a more robust delivery of the anchoring device 1 later, for example, by facilitating advancement of the anchoring device 1 around the collected tendons and other features.

[0103] After delivery catheter 114 is satisfactorily positioned around the tendon and other desired anatomical structures within the left ventricle, anchoring device 1 can be advanced from the distal opening of delivery catheter 114. Because the curved shape of rounded section 115 can be formed to substantially resemble the final curvature of anchoring device 1, the curved shape of rounded section 115 can facilitate smoother and easier ejection of anchoring device 1 from delivery catheter 114. Furthermore, the initial looping of distal region 117 around at least a portion of the desired mitral valve anatomical structure within the left ventricle can facilitate delivery of anchoring device 1 outside of and around the same anatomical structure already surrounded. Once the ventricular portion of anchoring device 1 has been advanced to the desired location in the left ventricle, the atrial portion of anchoring device 1 can be released from delivery catheter 114 in a manner similar to one of the various methods described above, for example, by rearward axial translation of delivery catheter 114. Such translational movement of the delivery catheter 114 may also serve to retract the delivery catheter 114 itself from the left ventricle and back into the left atrium. Then, after the anchoring device 1 is fully delivered and moved to the desired location, tension on the pullwires 135, 136 can be released and the delivery catheter 114 can be straightened and retracted through the guide sheath 20. A prosthesis (e.g., a THV or other prosthetic valve) can then be advanced and expanded within the anchoring device 1 in a similar manner, as previously described.

[0104] 20A-20E, 22, and 23 illustrate an exemplary embodiment of a delivery catheter that can operate in the same or similar manner as the delivery catheters 64, 114 described above. Any of the components, features, functions, elements, etc. (e.g., steering or actuation mechanisms, or pull wire systems, pull wires, rings, spines, etc.) of this embodiment can be incorporated into other delivery catheters (and even guide sheaths) described herein. In the example illustrated by FIGS. 20A-20E, 22, and 23, the distal region 117 of the delivery catheter 114 can be constructed from a flexible tube 2030 (e.g., which can be the same as or similar to the flexible tube 25'' shown in FIG. 19 or other tubes described herein). The delivery catheter has a steering / actuation mechanism or pull wire system that can be used to actuate and bend the distal region of the catheter. The steering / actuation mechanism or pull wire system herein may have one or more pull wires (e.g., 1-6 or more pull wires), one or more rings or pull rings (e.g., 1-7 or more rings), one or more spines, and / or other components.

[0105] In the illustrated embodiment, the delivery catheter has a two pull wire system including a first pull wire 2035, a second pull wire 2036, three rings or pull rings (i.e., a first ring 2037, a second ring 2038, and a third ring 2039), a first spine 2040, and a second spine 2041. FIG. 20A shows an end view of the distal section 117 of the delivery catheter 114. FIG. 20C shows a cross-sectional view of the delivery catheter 114 of FIG. 20A taken along the plane indicated by line CC. FIG. 20B shows a cross-sectional view of the delivery catheter 114 taken along the plane indicated by line BB. FIG. 20D shows a cross-sectional view of the delivery catheter 114 taken along the plane indicated by line DD in FIG. 20A. FIG. 20E shows a cross-sectional view of the delivery catheter 114 taken along the plane indicated by line EE in FIG. 20A. FIGS. 21A and 21B are schematic perspective views of a delivery catheter 114 in a partially and fully actuated state, respectively, similar to the views of FIGS. 15 and 16. FIG. 22A is a partial view of the delivery catheter 114. FIGS. 22B-22D show cross-sectional views of the delivery catheter along the planes indicated by lines BB, CC, and DD, respectively, in FIG. 22A. FIG. 23 is a side view of the two-pull wire system of the delivery catheter 114. For example, other delivery catheters or sheaths deployed and used in different manners as shown in any of the above-described embodiments can be constructed using a similar two-pull wire system. While the illustrated embodiment shows a delivery catheter 114 having rings 2037, 2038, 2039 and spines 2040, 2041, it should be understood that the delivery catheter 114 can be constructed with any number of rings and / or spines, or without any rings or spines.

[0106] In the illustrated embodiment, the delivery catheter 114 has a distal region 117 that includes two flexible sections 115, 116. Referring to FIG. 20C, the first flexible section 115 extends between a first ring 2037 and a second ring 2038. A first pull wire 2035 is attached to the first ring 2037 at connection point A, and actuation of the first pull wire 2035 causes the first flexible section 115 to form the generally circular configuration shown in FIGS. 11 and 12. FIGS. 20C and 20D and 22A and 22B show that an optional spine 2040 is connected between the first ring 2037 and the second ring 2038. The spine 2040 is made of a stiffer material than the flexible tube 2030 and is therefore configured to limit movement, such as compression, between the rings 2037, 2038 when the first pull wire 2035 is actuated. The spine 2040 may be made of, for example, stainless steel, plastic, or any other suitable material that is harder than the flexible tube. The flexible tube 2030 may be made of, for example, nitinol, steel, and / or plastic, or any suitable material or combination of materials that allows the delivery catheter 114 to be moved into a bent configuration (e.g., the bent configuration shown in FIG. 12 ). In certain embodiments, the ratio of the Shore D hardness of the spine 2040 to the Shore D hardness of the flexible tube 2030 is between about 3:1. In certain embodiments, the ratio of the Shore D hardness of the spine 2040 to the Shore D hardness of the flexible tube 2030 is between about 1.5:1 and about 5:1, e.g., between about 2:1 and about 4:1, e.g., between about 2.5:1 and about 3.5:1. In alternative embodiments, the ratio of the Shore D hardness of the spine 2040 to the Shore D hardness of the flexible tube 2030 is greater than 5:1 or less than 1.5:1.

[0107] In the illustrated embodiment, the spine 2040 is positioned substantially opposite the first pull wire 2035 such that the center of the spine 2040 is circumferentially offset by approximately 180 degrees from the first pull wire 2035. The center of the spine 2040 can be circumferentially offset from the first pull wire 2035 by about 70 degrees to about 110 degrees, such as about 80 degrees to about 100 degrees, e.g., about 85 degrees to about 95 degrees. With reference to FIG. 22B, the width of the spine 2040 (defined by angle theta (θ)) can be any suitable width that allows the delivery catheter 114 to move into the bent configuration shown in FIGS. 11 and 12. In certain embodiments, the angle theta between the edges 2201, 2203 of the spine 2040 can be between about 45 degrees and about 135 degrees, such as between about 60 degrees and about 120 degrees, such as between about 75 degrees and about 105 degrees, such as between about 85 degrees and about 95 degrees, such as between about 90 degrees. A larger angle theta allows the spine 2040 to have more control in limiting the movement of the rings 2037, 2038 compared to a smaller angle theta. The spine 2041 can be made of, for example, nitinol, steel, and / or plastic, or any other suitable material or combination of materials.

[0108] Referring to FIG. 20B, second flexible section 116 extends between second ring 2038 and third ring 2039. Second pull wire 2036 is attached to second ring 2038 at connection point B, and actuation of second pull wire 2036 causes second flexible section 116 to form the sharper bend shown in FIGS. 11 and 12. Referring to FIGS. 20B, 20E, 22A, and 22C, optional spine 2041 is connected between second ring 2038 and third ring 2039. Spine 2041 is made of a material that is stiffer than flexible tube 2030 and, therefore, is configured to limit movement between rings 2038, 2039 when second pull wire 2036 is actuated. Spine 2041 may be made of, for example, stainless steel, plastic, or any other suitable material that is stiffer than the flexible tube. The flexible tube 2030 may be made from, for example, nitinol, steel, and / or plastic, or any suitable material or combination of materials that allows the delivery catheter 114 to be moved into a bent configuration (e.g., the bent configuration shown in FIG. 12 ). In certain embodiments, the ratio of the Shore D hardness of the spine 2041 to the Shore D hardness of the flexible tube 2030 is between about 3:1. In certain embodiments, the ratio of the Shore D hardness of the spine 2041 to the Shore D hardness of the flexible tube 2030 is between about 1.5:1 and about 5:1, e.g., between about 2:1 and about 4:1, e.g., between about 2.5:1 and about 3.5:1. In alternative embodiments, the ratio of the Shore D hardness of the spine 2041 to the Shore D hardness of the flexible tube 2030 is greater than 5:1 or less than 1.5:1.

[0109] In the illustrated embodiment, the spine 2041 is positioned substantially opposite the second pull wire 2036 such that the center of the spine 2041 is circumferentially offset from the second pull wire 2036 by about 180 degrees. The center of the spine 2041 can be circumferentially offset from the second pull wire 2036 by about 70 degrees to about 110 degrees, such as about 80 degrees to about 100 degrees, such as about 85 degrees to about 95 degrees. With reference to FIG. 22C , the width of the spine 2041 (defined by angle beta (β)) can be any suitable width that allows the delivery catheter 114 to move into the bent configuration shown in FIG. 12 . In certain embodiments, the angle β between the edges 2205, 2207 of the spine 2041 can be about 45 degrees to about 135 degrees, such as about 60 degrees to about 120 degrees, such as about 75 degrees to about 105 degrees, such as about 85 degrees to about 95 degrees, or such as about 90 degrees. A larger angle of beta allows the spine 2040 to have more control (i.e., add more stiffness) in limiting the movement of the rings 2037, 2038 compared to a smaller angle of beta.

[0110] 20D and 20E, delivery catheter 114 includes lumen 2032 that is sufficiently sized for delivering anchoring device 1 therethrough, and lumen 2032 remains sufficiently sized for delivering anchoring device 1 when first pullwire 2035 and second pullwire 2036 are actuated to move delivery catheter 114 to the bent configuration shown in FIG. 12. Lumen 2032 may have, for example, an oval cross-section, a circular cross-section, or a cross-section having any other suitable shape, so long as anchoring device 1 can be effectively advanced therethrough.

[0111] Connection point B for attaching second pull wire 2036 to second ring 2038 is positioned proximal to connection point A for attaching first pull wire 2035 to first ring 2037 and may be circumferentially offset, for example, by approximately 90 degrees around distal region 117. The 90-degree offset allows for two orthogonal bends within the region, and the respective radii of curvature and directions of articulation of sections 115, 116 may be different and independent of one another. In some embodiments, sections 115, 116 may be circumferentially offset, for example, by about 65 degrees to about 115 degrees, e.g., about 75 degrees to about 105 degrees, e.g., about 80 degrees to about 100 degrees, e.g., about 85 degrees to about 95 degrees, etc. Referring to FIGS. 20C and 20E , in certain embodiments, wires 2035, 2036 extend along length L of delivery catheter 114 such that the wires are substantially parallel to axis X extending through the center of the delivery catheter. In this embodiment, the wires 2035, 2036 are circumferentially offset such that the angle between the wires 2035, 2036 is between about 65 degrees and about 115 degrees, for example between about 75 degrees and about 105 degrees, for example between about 80 degrees and about 100 degrees, for example between about 85 degrees and about 95 degrees, for example about 90 degrees.

[0112] 9A-9U and 20A-23, in practice, when guide sheath 20 is positioned proximate an annulus of a native valve (e.g., the mitral or tricuspid annulus), for example, in the position shown, a distal region of delivery catheter 114, including distal region 117 (and in some embodiments, a portion of proximal section 2034), advances from a distal opening of guide sheath 20. Here, the portion of delivery catheter 114 extending from guide sheath 20 may be positioned within an atrium (left or right atrium), and in some cases, a portion of delivery catheter 114 may also extend slightly (e.g., 1-5 mm or less) into a ventricle (e.g., the left or right ventricle) through the native valve (e.g., the native mitral valve) or a commissure of the native valve before delivery catheter 114 is adjusted to its actuated configuration, or, if partially actuated, its full or final actuated configuration. The pullwires 2035, 2036 can then be tensioned to actuate the distal region 117 and obtain two bending articulations of sections 115, 116 at the distal portion of the delivery catheter 114. For example, as shown in FIG. 21A , in one sequence, the second pullwire 2036 may first be tensioned to bend section 116 and bring the portion of the delivery catheter 114 distal to section 116 substantially flat relative to the native valve annulus (e.g., the native mitral valve annulus). Next, as shown in FIG. 21B , the first pullwire 2035 can be tensioned to bend section 115 into its rounded or curved actuated state such that the curvature of section 115 is substantially planar or parallel to the plane of the native valve annulus (e.g., the mitral plane). In other embodiments, the pull wires 2035, 2036 can be tensioned in partially or completely different amounts and / or sequences to properly and safely navigate around or against the patient's anatomy during actuation. For example, the pull wires 2035, 2036 can be tensioned to move the delivery catheter 114 in the same manner that the delivery catheter 64 is moved in FIGS. 9A-9U.Actuation of the pull wire or pull wire system can be used in combination with twisting or rotating the delivery device or a portion thereof (e.g., the delivery catheter or sheath) to direct the distal region and distal tip of the catheter to a desired position and / or orientation.

[0113] For example, after the distal region 117 of the delivery catheter 114 is fully actuated or actuated to a desired configuration (as shown in FIG. 21B), the assembly can be twisted and rotated so that the tip of the delivery catheter 114 is aligned with a commissure of the native valve (e.g., at commissure A3P3 of the native mitral valve). The delivery catheter 114 can be twisted and rotated so that the distal tip of the delivery catheter 114 is directed toward and / or within the commissure. Additionally, further rotation of the delivery catheter 114 may facilitate circumferential advancement of the distal tip of the delivery catheter 114 toward and / or into the commissure, and / or may facilitate changing direction from a downward orientation to a flatter or parallel (or less downward) orientation (e.g., after the first end of the anchoring device has been pushed or extruded from the delivery catheter) so that the end of the anchoring device does not undesirably rise after insertion, impinge on, or abut the underside of the valve annulus, and the anchoring device 1 can be looped or positioned outside the native anatomy (e.g., outside the native mitral valve anatomy), for example, around chordae tendineae, papillary muscles, and / or other features within the ventricle.

[0114] 22A-22D and 23, in certain embodiments, the delivery catheter 114 includes a first conduit 2210 (e.g., a tube, sleeve, etc.) for accommodating a first pull wire 2035 and a second conduit 2212 for accommodating a second pull wire 2036. In the illustrated embodiment, the conduits 2210, 2212 are defined at least in part by a liner 2215 and an inner surface 2216 of the flexible tube 2030. In some embodiments, the conduits 2210, 2212 can take any other suitable form. In some embodiments, no conduits are used to accommodate the pull wires 2035, 2036. The design of the proximal section 140 and the placement of the pull wires 2035, 2036 provide an anti-whipping or anti-bending effect through the delivery catheter 114 when the pull wires 135, 136 are actuated. This allows the full torqueability of the delivery catheter 114 to be maintained through transseptal bending. This can also facilitate the actuated shape of the distal region 117 being more effectively held and maintained during twisting or rotation during delivery. In some examples, the delivery catheter 114 includes a first coil sleeve 2211 that extends around the first pull wire 2035 until it reaches the first bend section 115, and a second coil sleeve 2213 that extends around the second pull wire 2036 until it reaches the second bend section 116. The coil sleeves 2211, 2213 are configured to provide an anti-whipping or anti-bending effect and to maintain the full torqueability of the delivery catheter 114.

[0115] Deployment of delivery device 1 from delivery catheter 114 (and optionally, movement of delivery catheter 114 around the anatomy within the ventricle) functions to collect or capture the enclosed anatomy within anchoring device 1. In some embodiments, distal region 117 of delivery catheter 114 is moved to a desired location around tendons and other features within the left ventricle, and first pullwire 135 is tensioned to reduce the radius of curvature of rounded section 115, passing through the center of rounded section 115 further toward the center of the native annulus and to constrict and gather the tendons and other mitral valve anatomy. Such radial constriction or gathering of mitral valve anatomy in the left ventricle can help to facilitate later more robust delivery of anchoring device 1, for example, by facilitating advancement of anchoring device 1 around the collected tendons and other features.

[0116] When a delivery catheter is used in the ventricle to surround native anatomy, anchoring device 1 can be advanced from the distal opening of delivery catheter 114 after delivery catheter 114 is satisfactorily positioned around the left ventricular tendon and other desired anatomy. Because the curved shape of rounded section 115 can be formed to substantially resemble the final curvature of anchoring device 1, the curved shape of rounded section 115 can facilitate smoother and easier ejection of anchoring device 1 from delivery catheter 114. Furthermore, the initial looping of distal region 117 around at least a portion of the desired mitral valve anatomy within the left ventricle facilitates delivery of anchoring device 1 outside of and around the same anatomy already surrounded. Once the ventricular portion of anchoring device 1 has been advanced to the desired location in the left ventricle, the atrial portion of anchoring device 1 can be released from delivery catheter 114 in a manner similar to one of the various methods described above, for example, by rearward axial translation of delivery catheter 114. Such translational movement of the delivery catheter 114 may also serve to retract the delivery catheter 114 itself from the left ventricle and back into the left atrium. Then, after the anchoring device 1 is fully delivered and moved to the desired location, tension on the pullwires 2035, 2036 can be released and the delivery catheter 114 can be straightened and retracted through the guide sheath 20. A THV or other prosthetic valve can then be advanced and expanded within the anchoring device 1 in a similar manner, as previously described.

[0117] In some embodiments (e.g., any of the delivery catheter embodiments described herein), an atraumatic tip 118 may also be formed at the end of distal region 117 to prevent or reduce potential damage to guide sheath 20 or the patient's anatomy when delivery catheter 114 is advanced and manipulated to its desired position and orientation. Atraumatic tip 118 may be an extension of distal region 117 formed with a rounded or other atraumatic shape, or may be an additional layer formed from a different material than distal region 117, for example, an additional braided layer, and / or may be made from a lower durometer material.

[0118] Optionally, the anchor or docking device can also include a low-friction sleeve, e.g., a PTFE sleeve, that fits around all or a portion (e.g., leading and / or functional bend) of the anchor or docking device. For example, the low-friction sleeve can include a lumen into which the anchor device (or a portion thereof) fits. The low-friction sleeve can facilitate sliding and / or rotating the anchor device into place as it exits the delivery catheter with less friction and less likely to cause abrasion or damage to native tissue than the surface of the anchor device. The low-friction sleeve can be removable (e.g., by pulling the sleeve proximally while holding the pusher and anchor device in place) after the anchor device is in place in the native valve to expose a surface of the anchor device that may be, or may include, a portion configured to promote tissue ingrowth (porous, braided, high surface area, etc.).

[0119] The delivery catheter configurations described herein provide exemplary embodiments that allow for precise positioning and deployment of the anchoring device. However, in some instances, retrieval or partial retrieval of the anchoring device may still be necessary at any stage during or after deployment, for example, to reposition the anchoring device with the native valve or to remove the anchoring device from the implant site. The following embodiments describe various locking or unlocking mechanisms that 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 proximally to a pusher or other mechanism that allows it to be easily pushed, retracted, and detached from the anchoring device.

[0120] In the previous example, the suture or thread of the pusher or pusher tool is passed through an opening or hole in the end of the anchoring device to hold the anchoring device and allow for retrievability and release of the anchoring device. Figures 17A-17C show perspective views of the proximal end 82 and ball locker or locking mechanism 84 of an exemplary anchoring device 81. The anchoring device 81 may be similar to the anchoring device embodiments described above with the addition of a modified proximal end 82, as seen in Figure 17A. The proximal end 82 of the anchoring device 81 has an elongated tubular structure 83 forming a locking tube, and the ball locking mechanism 84 includes a pusher 85 (which may be the same as or similar to other pushers herein, mutatis mutandis) and a pull wire 86 that interact with the locking tube 83. The pusher 85, shown cutout in Figures 17A-17C, includes a flexible tube 87 that may be of sufficient length to extend through a delivery catheter during deployment of the anchoring device 81. The pull wire 86 extends through the pusher 85 and can protrude through the distal end of the pusher 85 at a length that allows the pull wire 86 to also pass through the locking tube 83 of the anchoring device 81. The pusher 85 has a distal tip 88 and a short wire 89 connected to and / or extending from the pusher tip 88. The distal end of the short wire 89 includes a spherical ball 90.

[0121] A locking tube 83 at the proximal end 82 of anchoring device 81 is sized to receive a spherical ball 90 of a short wire 89 therethrough, as shown in FIG. 17B. The locking tube 83 is a short tube that may be welded or otherwise secured to the proximal end of anchoring device 81 (so that it is oriented during delivery). The inner diameter of locking tube 83 is slightly larger than the outer diameter of spherical ball 90 so that ball 90 can pass through it. The lock or locking mechanism is based on the relative diameters of the inner diameter of locking tube 83, the diameter of ball 90, and the diameters of the short wire 89 and the remainder of pull wire 86.

[0122] After the ball 90 passes through and exits the distal end of the locking tube 83, locking can be achieved by preventing the ball 90 from passing through and being expelled from the locking tube 83. This can also be achieved by inserting a pull wire 86 into the locking tube 83. When the thin portions of both the short wire 89 and the pull wire 86 are threaded and positioned through the locking tube 83, as shown in FIGS. 17C-17D, the ball 90 is blocked from passing back through the locking tube 83, thereby locking the anchoring device 81 to the pusher 85. As best seen in FIG. 17D, when the pull wire 86 is within the locking tube 83, the pull wire 86 prevents the short wire 89 from moving to a more central position in the bore of the locking tube 83, aligning the ball 90 with the locking tube 83 and preventing it from being withdrawn through the locking tube 83. Thus, the ball 90 abuts the distal end of the locking tube 83 when the pusher 85 is pulled proximally therefrom. In this locked position, the pusher 85 is locked to the anchoring device 81, and the pusher 85 can push or pull the anchoring device 81 to more precisely position it during surgery. Only when the pull wire 86 is withdrawn from the locking tube 83 is there a clear path and sufficient space for the ball 90 to align with and be released from the locking tube 83, unlocking or removing the anchoring device 81 from the pusher 85. Meanwhile, because the locking force relies primarily on the short wire 89, which bears most of the load when the mechanism is locked, only a relatively small pulling force is required to retract the pull wire 86 and unlock the anchoring device 81.

[0123] The pull wire 86 also only needs to be moved a short distance to be removed from the locking tube 83. For example, unlocking the anchoring device 81 from the pusher 85 may involve retracting the pull wire 86 by approximately 10 mm, removing the pull wire 86 from the locking tube 83, and releasing the spherical ball 90. In other embodiments, the anchoring device 81 may be unlocked from the pusher 85 by retracting the pull wire 86 by approximately 6 mm to approximately 14 mm, such as approximately 7 mm to approximately 13 mm, such as approximately 8 mm to approximately 12 mm, or such as approximately 9 mm to approximately 11 mm. In certain embodiments, the anchoring device 81 may be unlocked from the pusher 85 by retracting the pull wire 86 less than 6 mm or more than 14 mm. The embodiments of FIGS. 17A-17D provide a robust and reliable locking mechanism capable of achieving a strong locking force while, at the same time, requiring only a small pulling force to unlock and separate the components from one another.

[0124] In use, the ball-lock mechanism 84 can be assembled with the anchoring device 81 prior to implantation, as seen, for example, in FIG. 17C . After the distal section of the delivery catheter is positioned at or near the annulus of a native valve, e.g., a mitral valve, using one of the techniques described with respect to FIGS. 8, 9A-9U, and 10 above, the pusher 85 can push the anchoring device 81 through the delivery catheter, deploying the anchoring device 81. The user can then use the pusher 85 to further retract and / or advance the anchoring device 81 through the native valve annulus to more precisely position the anchoring device 81 at the implant site. Once the anchoring device 81 is precisely positioned, the pull wire 86 can be retracted from the locking tube 83, as shown in FIG. 17B , and the spherical ball 90 can then also be retracted and released from the locking tube 83, as shown in FIG. 17A , thereby detaching the anchoring device 81 from the ball-lock mechanism 84. The pusher 85 can then be removed from the implant site.

[0125] 18A-18C show perspective views of a proximal end 92 and loop locking mechanism 94 of an anchoring device 91 according to an embodiment of the present invention. The anchoring device 91 may be similar to the anchoring device embodiments described above with the addition of a modified proximal end 92, as seen in FIG. 18A. The proximal end 92 of the anchoring device 91 has an elongated proximal hole or slot 93, and the loop locking mechanism 94 includes a pusher 95 and a side wire or pull wire 96 that interacts with the hole 93. The pusher 95 includes a flexible tube 97 that may be long enough to extend through the delivery catheter during deployment of the anchoring device 91. The pull wire 96 extends through the pusher 95 and may protrude through the distal end of the pusher 95 a length that allows the pull wire 96 to engage a wire loop 99, as discussed in more detail below. The pusher 95 has a distal tip 98 and a wire loop 99 connected to and / or extending from the pusher tip 98. In this embodiment, the loop 99 extends distally from the distal tip 98 of the pusher 95 and has a distal loop portion that extends generally perpendicular to the longitudinal axis of the pusher 95. In this embodiment, the wire loop 99 is shown as a wire, such as a cylindrical metal wire, although the invention is not so limited. In other embodiments, the loop 99 may also be made from, for example, a flat piece of laser-cut metal or other material that can be formed using sutures, or can take any other suitable form that can enter the slot 93 of the anchoring device 91 and receive the pull wire 96 to secure the anchoring device 91 to the pusher 95.

[0126] Hole 93 in proximal end 92 of anchoring device 91 is sized to receive the end of wire loop 99, as shown in FIG. 18B. When wire loop 99 is threaded through hole 93, the end of wire loop 99 extends beyond the opposite side of hole 93, resulting in loop 99 being exposed or protruding from the opposite side. Loop 99 must be able to protrude from the opposite side of hole 93 by an amount sufficient to allow pull wire 96 to be inserted or threaded through loop 99, as shown in FIG. 18C. Then, as shown in FIG. 18C, by passing pull wire 96 through loop 99, anchoring device 91 can be attached or engaged to a locked position in which pusher 95 can push or pull anchoring device 91 to more precisely position anchoring device 91 during surgery. In this locked position, pull wire 96 secures loop 99 in place and prevents loop 99 from backing out of hole 93. Only when the pull wire 96 is pulled back from the loop 99 may the loop 99 be removed from the hole 93 and the anchoring device 91 unlocked or removed from the pusher 95. Meanwhile, retracting the pull wire 96 to unlock the anchoring device 91 requires only a relatively small pulling force, since the locking force is primarily dependent on the loop 99, which bears most of the load when the mechanism is locked.

[0127] The loop locking mechanism 94 relies on the interaction between the loop 99 of the pusher 95 and the pull wire 96. Therefore, the loop 99 should, on the one hand, be long or tall enough to protrude from the side of the hole 93 opposite the insertion side, leaving enough space for the pull wire 96 to pass through, and, on the other hand, be short enough to reduce vertical shift when locked in order to maintain a tight connection between the pusher 95 and the anchoring device 91. Thus, the embodiment of FIGS. 18A-18C provides a robust and reliable locking mechanism capable of achieving a strong locking force while requiring only a small pulling force and a small amount of retraction by the pull wire 96 to unlock the components. For example, unlocking the anchoring device 91 from the pusher 95 may simply involve retracting the pull wire 96 by approximately 10 mm to remove the pull wire 96 from the loop 99 and release the loop 99. In other embodiments, the anchoring device 91 can be unlocked from the pusher 95 by retracting the pull wire 96 by about 6 mm to about 14 mm, such as about 7 mm to about 13 mm, such as about 8 mm to about 12 mm, such as about 9 mm to about 11 mm, etc. In certain embodiments, the anchoring device 91 can be unlocked from the pusher 95 by retracting the pull wire 86 by less than 6 mm or more than 14 mm.

[0128] In use, the loop locking mechanism 94 can be pre-assembled with the anchoring device 91, as seen in FIG. 18C , before surgery. After the distal section of the delivery catheter is positioned at or near the annulus of a native valve, e.g., a mitral valve, using one of the techniques described with respect to FIGS. 8, 9A-9U, and 10 above, the pusher 95 can push the anchoring device 91 through the delivery catheter, deploying the anchoring device 91. The user can then use the pusher 95 to further retract and / or advance the anchoring device 91 through the native valve annulus to more precisely position the anchoring device 91 at the implant site. Once the anchoring device 91 is precisely positioned, the pull wire 96 can be retracted from the loop 99, as shown in FIG. 18B , which in turn can be retracted from the hole 93, thereby detaching the anchoring device 91 from the loop locking mechanism 94, as shown in FIG. 18A . The pusher 95 can then be removed from the implant site.

[0129] Additional pusher and retrieval devices, as well as other systems, devices, components, methods, and the like, are disclosed in U.S. Provisional Patent Application No. 62 / 436,695, filed December 20, 2016, and U.S. Provisional Patent Application No. 62 / 560,962, filed September 20, 2017, and related PCT patent application PCT / US2017 / 066865, entitled "SYSTEMS AND MECHANISMS FOR DEPLOYING A DOCKING DEVICE FOR A REPLACEMENT HEART VALVE," filed December 15, 2017 (which claims priority to the aforementioned provisional application), each of which is incorporated herein by reference in its entirety. Any of the embodiments and methods disclosed in the aforementioned applications may be used with any of the embodiments and methods disclosed by the present application, mutatis mutandis.

[0130] 24 shows a side view of a sheath catheter 1000, which may include a sheath 20 as discussed herein. The sheath 20 may include a distal portion 21 and a proximal portion 1002 (shown in cross section in FIG. 25). A handle 1004 may be positioned on the proximal portion 1002 of the sheath 20 and may be configured to be grasped by a user.

[0131] The sheath 20 is shown as an elongate body or shaft extending distally from a handle 1004 at the distal end of the sheath 20 to a distal tip 1006 of the sheath 20. The sheath 20 may be configured to pass through the vasculature of a patient's body and be directed to a site for deployment of an implant or catheter through an inner lumen 1034 of the sheath 20, shown in FIG. 25. The inner lumen 1034 may be configured to pass an implant or catheter through. The sheath 20 may comprise a cylindrical body, but in embodiments may have other shapes as desired.

[0132] The sheath 20 may be configured to be advanced into the patient's vasculature while the handle 1004 remains outside the patient's body. An introducer body, in embodiments, may be positioned within the inner lumen of the sheath 20 and may be utilized to introduce the sheath 20 into the patient's body. The introducer body may be retracted proximally from the inner lumen of the sheath 20 after introduction of the sheath 20 into the patient's body. The introducer body may be retracted proximally to keep the inner lumen open for passage of a catheter or implant.

[0133] In embodiments, the sheath 20 may be configured to deflect via a deflection mechanism. The deflection mechanism may include one or more pull tethers 1008 (labeled in FIG. 25), an actuator 1010, and one or more slide bodies 1012 (labeled in FIG. 25) that may be coupled to a proximal portion of the one or more pull tethers 1008. The deflection mechanism may be utilized to deflect the distal tip 1006 of the sheath 20 to position the distal tip 1006 as desired. Deflection of the distal tip 1006 may be in a single plane, or in embodiments, multiple different deflection planes may be utilized. The sheath 20 may be a steerable sheath 20.

[0134] The sheath catheter 1000 may further include a strain relief body 1014 that may be positioned on the outer surface of the sheath 20 at a proximal portion of the sheath 20. The strain relief body 1014 may extend circumferentially around the outer surface of the sheath 20. The strain relief body 1014 may act as a strain relief for the proximal portion of the sheath 20 when the sheath 20 is inserted into the patient's body. The strain relief body 1014 may be located adjacent to and distal to the handle 1004.

[0135] The handle 1004 may include an outer surface 1016 for a user to grasp during insertion of the sheath 20 into the patient's vasculature. The outer surface 1016 may be textured or otherwise configured to improve a user's grip during insertion or other movements of the sheath 20, including rotation of the sheath 20 about its longitudinal axis. The actuator 1010, in embodiments, may be positioned on the handle 1004 and may comprise a control knob or other form of actuator as desired. A distal portion of the handle 1004 may contact the strain relief body 1014, and a proximal portion of the handle may be configured to contact the valve body 1018.

[0136] The valve body 1018 may be positioned in a proximal portion of the handle 1004 and may be configured to reduce the flow of fluid out of the lumen of the sheath 20 from the proximal end. The valve body 1018 may include a valve housing 1020 and a valve 1022 (labeled in FIG. 25 ) that may be configured to allow devices such as catheters and implants to pass distally through the lumen of the sheath 20 and to reduce the flow of fluid (e.g., blood) proximally out of the sheath catheter 1000. The valve body 1018 may include a lumen 1023 (labeled in FIG. 25 ) configured to allow a catheter or implant to enter the lumen of the sheath 20.

[0137] The sheath catheter 1000 may further include a tube 1024 that may be utilized to transport fluid into or out of the lumen of the sheath 20. A valve 1026 may be positioned on the tube 1024 to control the flow of fluid through the tube 1024.

[0138] FIG. 25 shows a cross-sectional schematic view of the sheath catheter 1000 shown in FIG. 24 . Certain features of the sheath catheter 1000 may be omitted from the view of FIG. 25 . The cross-sectional view of the sheath catheter 1000 shows a pull tether 1008 extending along a pull tether lumen within the sheath 20. The pull tether 1008 may have a distal end that is attached to an attachment point, which may be at the distal portion of the sheath 20. The pull tether 1008 may extend longitudinally along the sheath 20 from the attachment point proximally to a proximal portion of the pull tether 1008. The proximal portion of the pull tether 1008 may be attached to a sliding body 1012, which may be configured to slide along the sleeve 1028 of the sheath catheter 1000. The pull tether in embodiments may include one or more pull wires or another form of pull tether as desired. The pull tether 1008 may be configured to be tensioned to deflect the distal portion 21 of the sheath 20.

[0139] The sliding body 1012 may include threads configured to engage with threads on the actuator 1010. The actuator 1010 may include, for example, an elongated threaded body 1031 that is coupled to a control knob of the actuator 1010. The sliding body 1012 may be configured to slide along rails 1030 (numbered in FIG. 42 ) that prevent rotation of the sliding body 1012. Thus, rotation of the actuator 1010 may cause corresponding longitudinal movement of the sliding body 1012 because the sliding body 1012 is prevented from rotating with the actuator 1010. Thus, longitudinal movement of the sliding body 1012 may retract or extend the pull tether 1008, and therefore deflect or straighten the sheath 20, respectively.

[0140] The handle 1004 may include a handle housing 1033 that holds the components of the sheath catheter 1000 therein. The handle housing 1033 may be positioned at a proximal portion of the sheath 20. The handle housing 1033 may extend circumferentially over components including the proximal portion of the sheath 20, the actuator 1010, and the distal portion of the outer housing 1032, which includes the sleeve 1028.

[0141] The sheath 20 includes an inner lumen 1034 extending from an opening 1036 at the distal tip 1006 of the sheath 20 proximally to the proximal end of the sheath 20. The inner lumen 1034 is configured to pass a catheter or implant therethrough. A catheter for passing through the inner lumen 1034 may comprise, for example, a delivery catheter 64 for delivering an implant in the form of an anchoring device 1 (e.g., a docking coil) as disclosed herein, or may comprise a catheter for delivering an implant in the form of a prosthetic heart valve, such as the heart valve delivery catheter 902 disclosed herein. In embodiments, the inner lumen 1034 may be configured to pass both the delivery catheter 64 and the heart valve delivery catheter 902.

[0142] The outer housing 1032 may be positioned at a proximal portion of the sheath 20 and may be configured to support the sheath 20 within the handle housing 1033. The outer housing 1032 in embodiments may include a spine. The outer housing 1032 may include a proximal portion 1038 and a distal portion 1040 in the form of a sleeve 1028. The sleeve 1028 may extend longitudinally along the proximal portion of the sheath 20 and may support the sheath 20. The sleeve 1028 may extend distally from the inner housing 1050 over the sheath 20. The sleeve 1028 may extend circumferentially around the sheath 20 and may include a cutout portion 1042 for the pull tether 1008 or other component to pass through. The sleeve 1028 may include a lumen within which the proximal portion of the sheath 20 is positioned. The sleeve 1028 may be made of a rigid material, such as metal or other rigid material that supports the proximal portion of the sheath 20.

[0143] The proximal portion 1038 of the outer housing 1032 may include a channel 1044 for receiving the tube 1024 (numbered in FIG. 24). The channel 1044 may pass from an outer surface of the outer housing 1032 to a cavity 1046 in the outer housing 1032 defined by an inner surface 1048 of the outer housing 1032. The configuration of the inner surface 1048 and the cavity 1046 is further shown in FIG.

[0144] The inner housing 1050 may be positioned within the cavity 1046 of the outer housing 1032. The inner surface 1052 of the inner housing 1050 may define a lumen 1054 for passing a catheter or implant therethrough and into the inner lumen 1034 of the sheath 20, as discussed herein. The inner housing 1050 may be positioned with a proximal portion of the sheath 20 sandwiched between the inner surface 1048 of the outer housing 1032 and the outer surface 1056 of the inner housing 1050. Such a configuration may improve the ability of a catheter or implant to pass through the lumens of the sheath 20 and the inner housing 1050.

[0145] 26, for example, shows a configuration of the proximal portion of a sheath catheter in which the proximal portion 1058 of the sheath 1060 is not sandwiched between the inner and outer housings. In such a configuration, when a catheter or implant passes through the proximal opening 1062 of the catheter, the catheter or implant may catch or become caught on the exposed proximal end 1064 of the sheath 1060. Such contact may result in tearing of the sheath 1060 or the catheter or implant passing through the sheath 1060.

[0146] Additionally, the tapered profile of the entrance of the housing 1066 into the sheath 1060 shown in FIG. 26 may make it difficult to pass a catheter or implant distally into the sheath 1060.

[0147] FIG. 27 shows a close-up cross-sectional view of the outer housing 1032 and inner housing 1050 shown in FIG. 25 . In such a configuration, the proximal portion 1002 of the sheath 20 is sandwiched between the inner surface 1048 of the outer housing 1032 and the outer surface 1056 of the inner housing 1050. The sheath 20 may include a portion 1068 having a cylindrical shape and may include a portion 1070 positioned proximally of the cylindrical portion 1068 and flaring radially outward from the portion 1068. The portion 1070 may flare radially outward to a proximal end 1072 of the sheath 20, which is sandwiched between the inner surface 1048 of the outer housing 1032 and the outer surface 1056 of the inner housing 1050. The inner housing 1050 overlaps the proximal end 1072 of the sheath 20. Thus, clamping this proximal portion of the sheath 20 may reduce the likelihood of snagging or catching the proximal end 1072 of the sheath 20, as may occur, for example, in the embodiment of FIG. 26. A smooth entry surface may be provided. In embodiments, a constant inner diameter may be provided for entry and passage through the sheath 20.

[0148] Additionally, the inner lumen 1054 of the inner housing 1050 may have a cylindrical shape, which may allow for easy entry of the sheath 20 into the inner lumen 1034.

[0149] In embodiments, the diameter 1074 of the sheath 20 at portion 1068 may be the same as or greater than the diameter 1076 of the lumen of the inner housing 1050. The diameter 1078 of the flared portion 1070 of the sheath 20 may be greater than the diameter 1076 of the lumen of the inner housing 1050 and may be greater than the outer diameter of the inner housing 1050.

[0150] FIG. 28 shows a cross-sectional view of the inner housing 1050. The inner housing 1050 may include a proximal portion 1080 including a proximal opening 1082 configured for a catheter or implant to pass through to enter the lumen 1054. The proximal portion 1080 may further include a channel 1084 configured to align with a channel 1044 in the outer housing 1032 (labeled in FIG. 27) to allow fluid to flow to the tube 1024 (labeled in FIG. 24). The channel 1084 may comprise a circular hole, or may comprise an elongated hole or slot, among other configurations. An alignment structure 1086 (shown in FIG. 29) may be utilized to rotationally align the inner housing 1050 with a cavity in the outer housing 1032 such that the channels 1044, 1084 align and enter corresponding recesses in the outer housing 1032. In embodiments, the configuration of the alignment features and recesses may be reversed, with the alignment features including recesses on the inner housing 1050 and the outer housing 1032 including protrusions for insertion into the recesses on the inner housing 1050. Other configurations may be utilized in embodiments.

[0151] The inner housing 1050 may include an intermediate portion 1088 having a diameter 1083 that is smaller than the diameter 1081 of the proximal portion 1080. The intermediate portion 1088 may further include an alignment structure 1086.

[0152] The inner housing 1050 may include a distal portion 1090 having a diameter 1085 smaller than the diameters of the intermediate portion 1088 and the proximal portion 1080. The distal portion 1090 may include a recess 1092 configured to receive the proximal portion of the sheath 20. The end 1095 of the intermediate portion 1088 may be configured to contact the proximal end 1072 of the sheath 20 when the inner housing 1050 is inserted into the outer housing 1032 and the proximal portion of the sheath 20 is positioned within the recess 1092.

[0153] The lumen 1054 of the inner housing 1050 may have a cylindrical shape with a constant diameter that extends from the proximal end of the proximal portion 1080 to the distal end of the distal portion 1090 .

[0154] Figure 29 shows a perspective view of the inner housing 1050. Figure 30 shows a top view of the inner housing 1050. Figure 31 shows an end view of the inner housing 1050.

[0155] 32 shows a variation on the inner housing 1050 where the proximal opening 1087 of the inner housing 1093 has a tapered shape. Such a configuration may improve the ability of a catheter or implant to pass through the lumen of the inner housing.

[0156] Figure 33 shows a cross-sectional view of the outer housing 1032 in a view that is rotated 90 degrees from the view shown in Figure 27. The outer housing 1032 is shown to include a cavity 1046 formed by an inner surface 1048 of the outer housing 1032 into which an inner housing 1050 mates.

[0157] The cavity 1046 includes a proximal portion 1094 configured to receive a sealing body 1097 (shown in FIG. 45 ), such as an O-ring. The sealing body 1097 may thus be positioned between the inner surface 1048 of the outer housing 1032 and the outer surface 1056 of the proximal portion 1080 of the inner housing 1050.

[0158] The sealing body 1097 (shown in FIG. 45) can be configured to form a seal with the valve body 1018 positioned proximally of the outer housing 1032 (as shown in FIG. 24).

[0159] The cavity 1046 may include a first intermediate portion 1096 positioned distal to the proximal portion 1094. The first intermediate portion 1096 may have a diameter 1089 smaller than the diameter of the proximal portion 1094 and is configured to fit the diameter of the proximal portion 1080 of the inner housing 1050. The surfaces of the housings 1050, 1032 may contact each other at this location. The first intermediate portion 1096 may include a channel 1044.

[0160] The cavity 1046 may include a second intermediate portion 1098 positioned distally of the first intermediate portion 1096 and may have a smaller diameter than the first intermediate portion 1096. The second intermediate portion 1098 may have a diameter 1091 configured to match the diameter of the intermediate portion 1088 of the inner housing 1050. The surfaces of the housings 1050, 1032 may contact each other at this location.

[0161] The cavity 1046 may include a third intermediate portion 1100 positioned distally of the second intermediate portion 1098 and may have a tapered shape that tapers to a smaller diameter 1111 than the second intermediate portion 1098. The third intermediate portion 1100 may be spaced from the distal portion 1090 of the inner housing 1050 to allow the sheath 20 to fit between the surfaces of the housings 1050, 1032 at this location.

[0162] The cavity 1046 may include a distal portion 1102 positioned distally of the third intermediate portion 1100 and may have a tapered shape that tapers to a smaller diameter 1113 than the third intermediate portion 1100 and may taper to the diameter 1104 of the sleeve 1028. The distal portion 1102 may taper such that the sheath 20 flares radially outward toward the inner surface of the outer housing 1032.

[0163] Variations in the configuration of the housings 1050, 1032 may be provided. In embodiments, the proximal portion 1038 of the outer housing 1032 may include a channel 1108 for receiving a pin 1110 (numbered in FIG. 45 ) configured to couple the handle 1004 to the valve body 1018.

[0164] The sheath 20 can be configured to be flexible so that the sheath 20 can be deflected as desired. Figure 34, for example, shows a cross-sectional view of a section of the sheath 20, illustrating the multi-layer construction of the sheath 20. The sheath 20 can include, for example, an inner layer 1112 facing the inner lumen 1034. The inner layer 1112 can comprise a liner made from a low-friction material, such as PTFE or another form of low-friction material.

[0165] The sheath 20 may include a first intermediate layer 1114 having a distal portion 1116 and a proximal portion 1118 having different properties. The distal portion 1116 may have, for example, greater flexibility (e.g., a lower durometer) than the proximal portion 1118. The distal portion 1116 may have greater flexibility in a portion of the sheath 20 configured to deflect upon activation of the deflection mechanism. For example, the material of the intermediate layer 1114 may include PEBAX or another form of material. The durometer of the distal portion 1116 may be 30-40 durometer, and the durometer of the proximal portion 1118 may be 50-60 durometer in embodiments, although other amounts may be utilized in embodiments as desired. The proximal portion 1118 may extend proximally from a flexible portion of the sheath 20 to the proximal end of the sheath 20.

[0166] The sheath 20 may include a second intermediate layer 1120 positioned outside the first intermediate layer 1114 and may include a braid or coil or other support material to support the sheath 20. An outer layer 1122 may cover the second intermediate layer 1120 and may include a lubricious layer for entry into the patient's vascular system.

[0167] Although the pull tether 1008 is not shown in FIG. 34 , it may extend proximally from the distal tip of the sheath 20. The pull tether 1008 may pass through a pull tether lumen 1124 (numbered in FIG. 36 ), which may be embedded within the body of the sheath 20. However, the pull tether 1008 may extend from the body of the sheath 20 such that the proximal portion of the sheath 20 sandwiched between the housings 1050, 1032 does not include the pull tether 1008. The presence of the pull tether 1008 may interfere with the ability of the proximal portion of the sheath 20 to be sandwiched between the housings 1050, 1032. The pull tether 1008 may further extend from the body of the sheath 20 to attach the tether 1008 to one or more of the sliding bodies 1012.

[0168] 35, for example, shows a cross-sectional view of a portion of sheath 20 showing pull tether 1008 extending from the body of sheath 20 at exit point 1126. Exit point 1126 may, in embodiments, be located within handle 1004 and, in embodiments, a portion of sheath 20 surrounded by sleeve 1028. In other embodiments, other locations may be utilized.

[0169] Figure 36 shows a cross-sectional view of sheath 20 taken along line 36-36 in Figure 35. The pull tether 1008 is shown extending into the body of sheath 20. Figure 37 shows a cross-sectional view of sheath 20 taken along line 37-37 in Figure 35. The pull tether 1008 is shown extending out from the body of sheath 20. The pull tether 1008 can be configured to couple to slide body 1012 (numbered in Figure 25) in such a configuration.

[0170] The configuration of the housings 1050, 1032 may advantageously allow the delivery catheter 64 disclosed herein and / or the heart valve delivery catheter 902 disclosed herein to be passed through the sheath catheter 1000 along with other forms of catheters or implants.

[0171] 38 shows the sheath catheter 1000 inserted into a patient's vasculature, i.e., the femoral vein 1128. The distal portion of the sheath 20 can be configured to pass through the interatrial septum of the patient's heart. The sheath 20 can reach the position shown in FIG. 2B, for example, and can perform any of the sheath 20 operations disclosed herein. For example, the sheath 20 can deflect to provide a desired orientation of the delivery catheter 64 as desired. A catheter or implant may pass through the lumen of the inner housing and the inner lumen of the sheath.

[0172] The pull tether of the sheath 20 may be tensioned to deflect the distal portion of the sheath. A delivery catheter 64 for an implant, such as a docking coil, may pass through the lumen of the inner housing and the inner lumen of the sheath. The docking coil may be deployed from the delivery catheter 64 to the native heart valve.

[0173] 9P. Thus, the sheath 20 may not be retracted proximally after deployment of the anchoring device 1 (e.g., a docking coil). Rather, the sheath 20 may pass through the atrial septum and through the atrial septal opening and remain in place. Such a configuration may reduce the number of procedural steps and may reduce the likelihood of damage to the atrial septal opening that may be caused by retracting the sheath 20 and separately passing the heart valve delivery catheter 902 through the atrial septal opening.

[0174] 39, for example, shows the sheath 20 remaining in place as the heart valve delivery catheter 902 advances into the left atrium 51. The sheath 20 remains in place to guide the heart valve delivery catheter 902 into the left atrium 51 and may serve to further deflect the catheter 902 to position it in a desired location. The docking coil is shown forming a coil that extends around the leaflets of the native heart valve. As disclosed herein, at least a portion of the docking coil may be configured to be positioned on the atrial side of the native heart valve (including portion 1a), and at least a portion of the docking coil may be configured to be positioned on the ventricular side of the native heart valve (with coil 12 shown in FIG. 39).

[0175] 40 shows the sheath 20 remaining in place and deflecting to position the catheter 902 as desired during implantation of the prosthetic heart valve. The prosthetic heart valve may be docked to a docking coil. The prosthetic heart valve may be positioned within the leaflets of the native heart valve and docked to the docking coil.

[0176] In embodiments, other forms of catheters and / or implants may be passed through the sheath catheter 1000, and the sheath catheter 1000 may be utilized according to other methods. The prosthetic valve may be deployed in the mitral or tricuspid valve, among other locations within the body.

[0177] The sheath catheter 1000 may be at least partially formed according to the methods of Figures 41-45. Figure 41 illustrates a mandrel 1130 that may be utilized according to embodiments herein. The mandrel 1130 may be configured to be heated and inserted into the cavity 1046 of the outer housing 1032 to flare the proximal portion of the sheath 20 radially outward relative to the inner surface of the outer housing 1032. The mandrel 1130 may be shaped to conform to the shape of the outer housing 1032.

[0178] FIG. 42 shows that the outer housing 1032 extends around the proximal portion of the sheath 20 so that the sheath 20 can be inserted into the sleeve 1028. In such a configuration, the proximal portion of the sheath 20 can be flared radially outward by a mandrel 1130 inserted into a proximal opening of the sheath 20. The mandrel 1130 can also be inserted into the cavity 1046 of the outer housing 1032. The proximal portion of the sheath 20 can be flared radially outward within the cavity of the outer housing, with the mandrel pressing the proximal portion against the inner surface of the outer housing. FIG. 43 shows such a configuration, for example, with the mandrel 1130 advanced into the proximal opening of the outer housing 1032. The heated mandrel 1130 can radially outwardly contact the inner surface of the outer housing 1032 to expand the proximal portion of the sheath 20.

[0179] Once the sheath 20 has expanded radially outward, the inner housing 1050 may be inserted into the cavity of the outer housing 1032 through the proximal opening of the outer housing 1032. The mandrel 1130 may be removed from the shaft 20 before the inner housing 1050 is inserted into the proximal opening of the outer housing 1032. FIG. 44, for example, shows the inner housing 1050 being inserted. The proximal portion of the sheath 20 may be sandwiched between the inner housing 1050 and the outer housing 1032, as disclosed herein. The sandwiching may reduce the likelihood of the proximal portion of the sheath 20 collapsing or shrinking after the sheath 20 flaring process.

[0180] The remainder of the sheath catheter 1000 may be formed with the pull tether 1008 coupled to the slide body 1012, and the handle housing assembled around the sleeve 1028 and coupled to the outer housing 1032. A sealing body 1097 (such as an O-ring) may be positioned within a recess positioned between the inner housing 1050 and the outer housing 1032. FIG. 45 shows, for example, such a resulting configuration. A pin 1110 may be provided for coupling with the valve body 1018.

[0181] The steps for forming all or part of the sheath catheter 1000 may vary between embodiments as desired.

[0182] 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 for the controls / knobs. This can be done by connecting (directly or indirectly) some or all of the moving parts to a motor (e.g., an electric motor, an air motor, a hydraulic motor, etc.) that is actuated by the button or electrical input. For example, the motor may be configured to tension or relax the control wires or pull wires described herein, causing the distal region of the catheter to move. Additionally or alternatively, the motor may be configured to, upon actuation, move a device, such as a pusher, translationally or axially relative to the catheter to move an anchoring or docking device within and / or out of the catheter. Automatic stops or safeguards may be incorporated, for example, to prevent movement of components beyond a certain point, preventing damage to the system / device and / or the patient.

[0183] 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.

[0184] For purposes of this specification, certain aspects, advantages, and novel features of the disclosed embodiments are described herein. The disclosed methods, apparatus, and systems should not be construed as limiting in any way. Instead, the present 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 one another. The methods, apparatus, 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 be present or problems be solved. Features, elements, or components of one embodiment can be combined with other embodiments herein.

[0185] Although some operations of the disclosed embodiments are described in a particular sequential order for convenience of presentation, it should be understood that this method of description encompasses rearrangements unless a particular order is required by specific terminology. For example, operations described sequentially may, in some cases, be rearranged or performed simultaneously. Moreover, for simplicity, the accompanying drawings may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Furthermore, the description may use terms such as "provide" or "achieve" to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations corresponding to these terms may vary depending on the particular implementation and are readily discernible by those skilled in the art. Steps of various methods herein may be combined.

[0186] 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 examples of the present invention and should not be considered as limiting the scope of the present disclosure. Rather, the scope of the present disclosure is defined by the following claims.

Claims

[Claim 1] 10. A system for insertion into a portion of a patient's body substantially as herein described with reference to the specification and accompanying drawings.

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