Heart valve docking device and system

Abstract

To provide novel docking devices.SOLUTION: Docking devices for docking a prosthetic valve at a native valve of a heart can include a coiled docking anchor and a retrieval suture. The docking device and retrieval suture can be configured for improved retention and retrieval of the docking device after deployment. The docking devices can have an end portion with a central axis. The retrieval suture can be connected to the end portion, so that a line of force applied by applying tension to the retrieval suture is substantially aligned with the central axis.SELECTED DRAWING: Figure 27C

Description

Technical Field

[0001] [Cross - Reference to Related Applications] This application claims the priority of U.S. Patent Application No. 15 / 902,956, filed on February 22, 2018. U.S. Patent Application No. 15 / 902,956 is a continuation - in - part of U.S. Patent Application No. 15 / 682,287, filed on August 21, 2017. U.S. Patent Application No. 15 / 682,287 claims the benefit of U.S. Provisional Patent Application No. 62 / 395,940, filed on September 16, 2016, and U.S. Provisional Patent Application No. 62 / 380,117, filed on August 26, 2016. These applications are hereby incorporated by reference in their entirety.

[0002] The present invention generally relates to medical devices and procedures related to artificial heart valves. More particularly, the present invention relates to the replacement of heart valves that may have deformities and / or dysfunctions. Embodiments of the present invention can, for example, hold and maintain the position of an artificial heart valve to replace the function of a natural heart valve for mitral or tricuspid valve replacement procedures, as well as the implantation procedures related to such an anchor or docking device and / or an assembly including such an anchor or docking device and an artificial heart valve.

Background Art

[0003] First, referring to FIGS. 1 and 2, the mitral valve 50 controls the blood flow between the left atrium 52 and the left ventricle 54 of the human heart. After the left atrium 52 receives oxygen - rich blood from the lungs via the pulmonary veins, the mitral valve 50 allows the flow of oxygen - rich blood from the left atrium 52 into the left ventricle 54. When the left ventricle 54 contracts, the oxygen - rich blood held in the left ventricle 54 is sent through the aortic valve 56 and the aorta 58 to the rest of the body. On the other hand, the mitral valve needs to close during ventricular contraction to prevent the backflow of blood into the left atrium.

[0004] When the left ventricle contracts, the blood pressure inside the left ventricle substantially increases, which helps the mitral valve close. Because the pressure difference between the left ventricle and left atrium is large during this time, a significant pressure is placed on the mitral valve, potentially causing the mitral valve leaflets to prolapse or abduct into the atrium. Therefore, a series of chordae tendineae 62 connect the mitral valve leaflets to papillary muscles located on the left ventricular wall. During left ventricle contraction, both the chordae tendineae and papillary muscles exert tension, holding the leaflets in a closed position and preventing them from stretching towards the left atrium. This helps prevent oxygenated blood from flowing back into the left atrium. The chordae tendineae 62 are schematically shown in both the cardiac cross-section in Figure 1 and the mitral valve top view in Figure 2.

[0005] Figure 2 shows the general shape of the mitral valve and its leaflets as viewed from the left ventricle. The commissures 64 are located at each end of the mitral valve 50 where the anterior leaflet 66 and posterior leaflet 68 meet. Various complications of the mitral valve can, in some cases, lead to fatal heart failure. One form of valvular heart disease is mitral valve leak or mitral valve regurgitation, characterized by abnormal leakage of blood from the left ventricle through the mitral valve into the left atrium. This can occur, for example, when the spontaneous mitral leaflets do not fully align due to left ventricular expansion, or when the spontaneous leaflets are damaged, or when the chordae tendineae and / or papillary muscles are weakened (or damaged). In such situations, it may be desirable to repair the mitral valve or replace its function with that of an artificial heart valve.

[0006] Regarding valve replacement, while open-heart surgery is a more readily available option, there has been little progress in commercially available methods for replacing the mitral valve by catheter implantation and / or other minimally or less invasive procedures. In contrast, the field of transcatheter aortic valve replacement has developed much more and achieved widespread success. This discrepancy is partly due to the fact that mitral valve replacement is in many respects much more difficult than aortic valve replacement, for example, due to the non-circular physical structure of the mitral valve, its quasi-annular biostructure, and the greater difficulty in accessing the mitral valve. Due to the successful development of transcatheter aortic valve technology, it may be advantageous to use the same or similar circular valve prostheses for mitral valve replacement.

[0007] One of the most significant obstacles to mitral valve replacement is that the valve becomes effectively fixed or immobilized in the mitral position due to the large circulatory load it experiences. As noted above, another problem with mitral valve replacement is the size and shape of the native mitral valve loop, as can be seen in Figure 2. The aortic valve is closer to a round or cylindrical shape than the mitral valve. Furthermore, both the mitral and tricuspid valves are larger than the aortic valve and have a more elongated shape, making them more difficult and unusual sites for implanting replacement valves with generally round or cylindrical valve frames. If a good seal is not established around the valve, an excessively small round prosthesis may leak around the implant (i.e., paravalvular leakage), while an excessively large round prosthesis may stretch and damage the narrower portion of the native mitral valve loop. In addition, aortic valve replacement is often required due to, for example, aortic stenosis, in which case the aortic valve narrows due to calcification or other hardening of the native valve leaflets. Therefore, the aortic valve loop generally forms a smaller, more rigid, and more stable implantation site for a prosthetic valve than the mitral valve loop, which is larger and non-circular than the aortic valve loop. In cases of mitral regurgitation, the formation of such a good implantation site is unlikely. Furthermore, the presence of chordae tendineae and other biostructures in the mitral position can form obstacles that pose a much more serious problem in properly implanting the device in the mitral position.

[0008] Other obstacles to effective mitral valve replacement may arise due to the large circulatory load the mitral valve is subjected to and the need to establish sufficiently strong and stable fixation and retention. Furthermore, even slight misalignment of the valve can obstruct blood flow in the heart valve or other parts, or otherwise adversely affect them. [Overview of the Initiative] [Means for solving the problem]

[0009] This summary is intended to provide some examples and is not intended to limit the scope of the invention. For example, some special mechanisms included in the examples in this summary are not required in the claims unless expressly stated in the claims. Furthermore, the special mechanisms described can be combined in various ways. The description herein relates to systems, assemblies, methods, devices, apparatus, combinations, etc., that may be used to treat valves in animals. Various special mechanisms and steps described elsewhere in this disclosure may be included in the examples summarized herein.

[0010] One method of applying existing circular or cylindrical transcatheter valve technology to non-circular valve replacement (e.g., mitral valve replacement, tricuspid valve replacement, etc.) is to use an anchor (e.g., mitral anchor) or docking device or docking station that holds such prosthetic valves by forming or otherwise configuring a docking site that is closer to circular in the natural valve location. In this way, existing expandable transcatheter valves developed for aortic locations, or similar valves slightly modified to more effectively mimic mitral valve function, can be reliably implanted by such a docking device located in the natural valve loop (e.g., natural mitral valve loop). The docking device can first be placed at the location of the natural valve loop, and then the valve implant or transcatheter heart valve can be advanced and positioned through the docking device during its folded position, and then expanded, for example, via self-expansion (e.g., for valves composed of NiTi or another shape memory material), balloon expansion, or mechanical expansion, thereby radially pressing the frame of the prosthetic valve between the two and the docking device and / or tissue, thereby holding the valve in place. The docking device may also be delivered minimally or minimally invasively via the same or similar transcatheter technique used to deliver the transcatheter heart valve, thereby eliminating the need for a completely separate procedure to implant the docking device before delivering the prosthetic valve.

[0011] Therefore, it is desirable to provide devices and methods that can be used to facilitate the docking or fixation of such valves. Embodiments of the present invention provide a stable docking station or docking device for holding an artificial valve (e.g., an artificial mitral valve). Other special mechanisms are provided to improve the deployment, placement, stability, and / or integration of such docking stations and / or replacement prostheses that are to be held inside. These devices and methods can more securely hold the artificial valve and prevent or significantly reduce backflow or leakage of blood around the artificial valve. Such docking devices and methods can be used in various valve replacement procedures, e.g., mitral valve replacement, tricuspid valve replacement, pulmonary valve replacement, or aortic valve replacement, to enable more secure and firm fixation and retention of the valve implant at the site of the natural valve loop in such a position.

[0012] Docking devices for docking an artificial valve to a natural valve of the heart (e.g., mitral valve, tricuspid valve, etc.) can include a variety of special mechanisms, components, and characteristics. For example, such a docking device can include a coiled anchor having at least one central winding (e.g., a full-rotation or partial-rotation central winding) defining a central winding diameter. The at least one central winding can be one or more functional windings / coils. The coiled anchor can include lower windings extending from at least one central winding defining a diameter larger than the central winding diameter. The lower windings can be induction windings / coils. The coiled anchor can also include an upper winding connected to the central winding. The upper winding can be one or more stabilizing windings / coils. The upper winding can be shaped to have a first diameter along a first axis and a second diameter along a second axis. The first axis diameter of the upper winding can be larger than the central winding diameter, and the second axis diameter can be larger than the central winding diameter and smaller than the lower winding diameter. The various coiled anchors described herein can be configured to be implanted at the site of a natural valve (e.g., a natural mitral valve, a tricuspid valve, etc.) by positioning at least a portion of at least one central coil of the coiled anchor within the cardiac chamber (e.g., the left ventricle) and around the leaflets of the natural valve.

[0013] Any coiled anchor described herein may include an extension having a length extending from the upper end of at least one central winding to the upper winding / coil or stabilizing winding / coil. The extension may have a smaller thickness compared to other parts of the coiled anchor, such as at least one central winding, upper winding, lower winding, etc. The extension may extend perpendicularly to at least one central winding at angles of 60–120 degrees, 70–110 degrees, 80–100 degrees, and 90 degrees.

[0014] Various docking devices for docking an artificial valve to a natural valve of the heart may have a coiled anchor having a proximal and distal tip (for example, the same or similar coiled anchor as other coiled anchors described herein). The coiled anchor may include at least one central winding (for example, a full central winding or a partial central winding, which may be the same or similar to other central windings or functional windings described herein). The at least one central winding may have a first thickness and define a central winding diameter. Any coiled anchor described herein may also include an extension having a length extending from the upper end of at least one central winding. The coiled anchor may also include an upper winding extending from the upper end of the extension (for example, the same or similar to other upper windings or stabilizing windings / coils described herein). The extension may have a second thickness smaller than the first thickness. The upper winding may have a third thickness larger than the second thickness. As described above, the coiled anchor can be configured to be implanted at the site of a natural valve (e.g., a natural mitral valve, tricuspid valve, etc.), with at least a portion of the coiled anchor, either a full central coil or a partial central coil, positioned within the cardiac chambers of the heart (e.g., the left ventricle) and around the leaflets of a natural heart valve (e.g., the mitral leaflets).

[0015] Various docking devices for docking an artificial valve to a natural valve of the heart may also have a coiled anchor (for example, the same as or the same as the other coiled anchors described in this disclosure) having a proximal tip and a distal tip and at least one central winding defining a diameter (for example, a full central winding or a partial central winding, which may be the same as or the same as the other central windings / coils or functional windings / coils described herein). The coiled anchor may also have an upper winding connected to at least one central winding. A cover layer may surround the coiled anchor along all or at least a portion of the at least one central winding. The cover layer may be connected to the coiled anchor. At least one friction-reinforcing layer may be disposed on the coiled anchor and / or the cover layer. At least one friction-reinforcing layer may be disposed on at least a portion of the at least one central winding. The coiled anchor may be configured such that no portion of the upper winding is covered by the friction-reinforcing layer. Coiled anchors can also be configured to be implanted in the location of natural valves (e.g., natural mitral valves), with at least a portion of at least one central coil of the coiled anchor positioned within the cardiac chambers (e.g., left ventricle) and around the leaflets of the natural valve.

[0016] Any of the coiled anchors of any of the docking devices described herein may include one or more cover layers or cores of the coiled anchor that surround all or at least part of the coiled anchor. For example, a cover layer may surround all or at least part of at least one central winding (or all of the central winding / coil or functional winding / coil of the coiled anchor) and / or other parts of the coiled anchor. The cover layer can be connected to the coiled anchor in a variety of ways. The cover layer may be a high-friction cover layer or a low-friction cover layer, or both low-friction and high-friction cover layers may be used together. A low-friction cover layer may surround the coiled anchor core (e.g., the entire length of the coiled anchor) and be configured to extend beyond the proximal tip and / or distal tip. A low-friction cover layer may have a tapered tip or a rounded tip at its distal and / or proximal end. A high-friction cover layer or a cover layer with a higher coefficient of friction (for example, a cover layer with a higher coefficient of friction than a low-friction cover layer) can surround a portion of the low-friction cover layer and / or a portion of the coiled anchor (at least one central winding, all or part of it).

[0017] Any of the coiled anchors described herein may include at least one friction-reinforcing element or more friction-reinforcing elements. At least one friction-reinforcing element may be located on all or part of the coiled anchor or on the coating / layer of the coiled anchor. At least one friction-reinforcing element may be a plurality of bulges on the surface of the coiled anchor or the surface of the coating, or may include a plurality of bulges on the surface of the coiled anchor or the surface of the coating. The bulges may be made of PET, polymer, cloth, or another material. The bulges may extend along a certain length of the coiled anchor or coating along at least a portion of the central winding / coil.

[0018] In some cases, at least one friction-enhancing element may be a plurality of keyhole-shaped notches and key-shaped notches on the outer surface of the coiled anchor, or may include a plurality of keyhole-shaped notches and key-shaped notches on the outer surface of the coiled anchor. The keyhole-shaped notches may be grooves formed on the outer surface of the coiled anchor, and the key-shaped notches may be projections extending outward from the coiled anchor and may have a size and shape that fits into the keyhole-shaped notches.

[0019] A system for implanting a docking device at the site of a natural valve of the heart may include a docking device (for example, any docking device described above or elsewhere in this disclosure). The docking device may include an opening or bore, and the system may include a suture passed through the opening or bore. The system may also include a delivery catheter and a pusher device disposed within the delivery catheter. The pusher device may include a central lumen for receiving or through which the suture passes. The pusher device and suture are such that when the suture is pulled, a coiled anchor is pulled relative to the pusher device, and when the pusher device is pulled into the delivery catheter, the coiled anchor is pulled into the delivery catheter. The suture may be disposed within the central lumen such that when the suture and / or pusher device is pulled proximal to the delivery catheter, the coiled anchor or the delivery device is pulled into the delivery catheter.

[0020] A docking device for docking an artificial valve to a natural mitral valve of the heart may have a coiled anchor including a hollow tube. The hollow tube may have a proximal locking mechanism and a distal locking mechanism. Multiple notches may be provided through each part of the tube. The notches may have a pattern and shape that incorporates either or both longitudinal and transverse notches. If the notches have a pattern and shape that incorporates both longitudinal and transverse notches, they may form teeth and grooves in the hollow tube. The docking device may also have a wire, the distal end of which can be fixed to the distal locking mechanism. A certain length of the wire (e.g., the entire length or a portion of the wire) may extend through the hollow tube and apply radially inward tension to the hollow tube. The hollow tube is configured to at least partially surround the leaflets of the natural mitral valve and form a docking surface for an expandable artificial valve.

[0021] Methods used to implant a docking device for an artificial valve in the place of a natural heart valve may include a variety of steps (for example, any of the steps described throughout this disclosure). The docking device implanted by these methods may be any of the docking devices described herein. For example, a docking device implantable by these steps may have a coiled anchor having at least one full or partial winding defining a central diameter, an extension having a length extending from the upper end of at least one central winding, and an upper winding extending from the upper end of the extension. The distal end of a delivery catheter may be positioned in the first cardiac chamber of the heart (for example, the left ventricle). In some cases, the delivery catheter may be advanced and positioned through a guide sheath that has already been implanted. The delivery catheter may include a docking device in a first configuration. The distal end of the docking device may be advanced from the delivery catheter, thereby the docking device taking on a second configuration when advanced and / or implanted. The docking device is advanced through the valve loop (e.g., the natural mitral valve loop) into the second chamber of the heart (e.g., the left ventricle), thereby the distal tip loosely encircles any chordae tendineae and natural valve leaflets of the natural valve (e.g., the mitral valve). The extension portion of the docking device can be advanced, thereby positioning the upper end of the extension portion into the first chamber (e.g., the left atrium). The upper portion of the docking device can be advanced and released into the first chamber (e.g., the left atrium), thereby the upper portion contacts the wall of the first chamber (e.g., the left atrial wall). The replacement valve can be implanted within the docking device. For example, the replacement valve can be inserted into the internal space defined by the docking device of the second configuration. The replacement valve can be radially expanded until a retaining force acts between the replacement valve and the docking device to hold the replacement valve in a stable position. Natural valve leaflets or other tissues can be clamped between the delivery device and the prosthetic valve.

[0022] Valve replacement can be achieved by docking an expandable transcatheter heart valve into the natural valve site using a coiled anchor or docking device. The coiled anchor or docking device provides a more stable base or site for expanding the prosthetic valve. Thus, embodiments of the present invention provide a more robust method for implanting a replacement heart valve even in sites such as the natural mitral valve loop, where the valve loop itself may be non-circular or, in some cases, have a variable shape.

[0023] One or more of the systems described herein may be systems for implanting a docking device at the site of a natural valve and / or for retrieving the docking device. The system may comprise a variety of special mechanisms and components described herein, including a delivery catheter and a coiled docking device having ends (e.g., an elongated coiled docking device). The system may also include a pusher device having a central lumen, which may be disposed within the delivery catheter. A retrieval line (e.g., a retrieval suture) may extend through the central lumen of the delivery catheter and be coupled to the ends of the coiled docking device.

[0024] The system is configured to facilitate pulling the docking device toward the pusher device and / or drawing the docking device into the delivery catheter without the end of the docking device becoming entangled in a T-shape on or at the end of the pusher device and / or delivery catheter. For example, the system, e.g., end and retrieval line, is configured such that when the retrieval line is pulled, the end of the coiled anchor is pulled toward the pusher device and / or delivery catheter, helping to guide the end of the coiled anchor and the docking device into the delivery catheter. The nearest or nearest tip of the end can be curved to help align the end with the pusher tube and / or delivery catheter for retrieval. The end and retrieval line can also be biased so that the tension when pulled is substantially aligned with the central axis of the end of the coiled docking device, or configured and coupled so that when the retrieval line is pulled, the tension is aligned with the central axis of the end of the coiled docking device. The tension is offset from the central axis of the end and also aligned with the axis of the pusher device and / or delivery catheter, thereby aligning the end so that it is drawn into the delivery catheter, for example.

[0025] The end can be configured to align at least the longitudinal portion of the retrieval line with the central axis. The retrieval line can be positioned to extend through the central passage at the tip of the end of the docking device. The central passage can be aligned with or coaxial with the central axis.

[0026] The docking device can comprise a spherical tip (e.g., ball-shaped, hemispherical, etc.). The spherical tip can be configured to receive a retrieval line through a passage aligned with the central axis at the end of the coiled docking device. The proximal tip can comprise an annular groove at the transition of the proximal tip. The distal end of the pusher device can be configured to engage a spherical surface at the end of the coiled anchor and can draw a portion of the spherical tip somewhat into the lumen of the pusher device.

[0027] The end of the docking device can comprise a tip having a loop, and the retrieval line can be connected to this loop.

[0028] The end of the docking device can comprise a tip having a groove, and the retrieval suture can be coupled to an end within the groove, for example, by tying to the groove, coupling to a suture loop within the groove, or at least partially winding within the groove.

[0029] The coiled docking device of the system can include at least one central coil having a first thickness and defining a central coil diameter, an extension or transition portion having a length extending from the proximal end of the at least one central coil and having a second thickness smaller than the first thickness, and a proximal coil or upper coil extending from the proximal end or upper end portion of the extension portion. The proximal coil can have a third thickness greater than the second thickness. The coiled docking device can also comprise a distal coil or lower coil on an end of the coiled docking device opposite the proximal coil or upper coil and the end. The distal coil or lower coil can have the first thickness and can define a diameter larger than the central coil diameter. The end of the coiled docking device can be located at the proximal end of the proximal coil.

[0030] The coiled docking device is configured to be implanted at the site of a natural valve, with at least a portion of the coiled docking device positioned within the cardiac chambers and around the leaflets of the natural valve. The coiled docking device can be configured to be implanted at the site of a natural mitral valve, with at least a portion of the coiled docking device positioned within the left ventricle and around the mitral leaflets of the natural mitral valve. The coiled docking device can be configured to be implanted at the site of a natural tricuspid valve, with at least a portion of the coiled docking device positioned within the left ventricle and around the tricuspid leaflets of the natural tricuspid valve.

[0031] The system and / or coiled docking device may include a cover layer containing a biocompatible material, the cover layer enclosing at least a portion of the coiled anchor. The cover layer may be a low-friction cover layer having a distal end and a proximal end. The cover layer may enclose the coiled docking device and extend along a certain length of the coiled docking device, beyond the distal end of the coiled docking device and beyond the proximal end of the coiled docking device, with the low-friction cover layer tapering to a rounded tip at its distal end. The system and / or coiled docking device may include a friction-enhancing element, the friction-enhancing element may comprise a second cover layer enclosing at least a portion of the cover layer and extending along at least a portion of the cover layer, the second cover layer having a coefficient of friction of at least 1 (or one of the other friction-enhancing elements described elsewhere herein). The second cover layer may be a knitted material.

[0032] A coiled docking device may comprise at least one central winding defining a central winding diameter, a distal winding or lower winding extending from at least one central winding defining a distal winding diameter or lower winding diameter larger than the central winding diameter, and an upper winding or proximal winding connected to at least one central winding, wherein the upper winding or proximal winding is shaped to have a first diameter along a first axis and a second diameter along a second axis. The first axis diameter may be larger than the central winding diameter, and the second axis diameter may be larger than the central winding diameter and smaller than the lower winding diameter or distal winding diameter.

[0033] A coiled docking device may comprise a hollow tube having a proximal and distal end, as well as multiple notches in each part of the tube. The coiled docking device may also comprise a wire having a certain length, a proximal end, and a distal end. The distal end of the wire can be fixed to the distal end of the hollow tube, and the proximal end of the wire can be fixed to the proximal end of the hollow tube. The length of the wire can extend through the hollow tube, applying radially inward tension to the hollow tube. The notches may have patterns and shapes incorporating both longitudinal and transverse notches that form teeth and grooves in the hollow tube.

[0034] The coiled docking device may include a skeleton or core, the distal end of which may have a rectangular cross-section and a distal ring-shaped tip.

[0035] The coiled docking device may include a skeleton or core, and at least one end of the skeleton or core may have a ball-shaped tip.

[0036] In one embodiment, a docking device is provided for docking an artificial valve to a natural valve of the heart, which may include any of the special mechanisms and components described above and elsewhere in this specification with respect to docking devices. For example, the docking device may include or be a coiled docking device having ends that include a central axis. The ends of the docking device may be configured such that the line of force applied to the retrieved suture by tension is aligned with the central axis by biasing the retrieved suture connected to the ends.

[0037] A method for retrieving a coiled docking device from within the heart may include the steps of drawing a retrieval line to pull the end of the coiled docking device against a pusher device and / or into a delivery catheter. The end of the coiled docking device may be configured as any of the ends described above or elsewhere in this specification. For example, the end may be configured to deflect the retrieval line so that the tension applied by the pulling is aligned with the central axis of the end of the coiled docking device. This method may include the steps of pulling the pusher device and / or the end of the coiled docking device into a delivery catheter.

[0038] Further special mechanisms and advantages of the present invention will become apparent from the description of embodiments with reference to the accompanying drawings. [Brief explanation of the drawing]

[0039] [Figure 1] This is a schematic cross-sectional view of a human heart. [Figure 2] This is a schematic top view of the human mitral valve loop. [Figure 3] This is a perspective view of an exemplary anchor / docking device. [Figure 4] Figure 3 is a side view of the anchor. [Figure 5] Figures 3 and 4 are top views of the anchors. [Figure 6] Figures 3 to 5 are cross-sectional views of a portion of the heart during the step of sending the anchor to the natural mitral valve. [Figure 7] Figures 3-5 are cross-sectional views of a portion of the heart during the further steps of sending the anchor to the natural mitral valve loop. [Figure 8] Figures 3 to 5 show cross-sectional views of a portion of the heart where the anchor is positioned at the natural mitral valve loop. [Figure 9] Figures 3-5 show cross-sectional views of a portion of a heart where an anchor and an artificial mitral valve have been implanted in the natural mitral valve loop. [Figure 10] This is a perspective view of an exemplary anchor / docking device, similar in many respects to the anchor / docking devices shown in Figures 3 to 5. [Figure 11] This is a schematic perspective view of an exemplary laser-cut tube that can be used as an anchor / docking device. [Figure 11A] This is a schematic open view of a laser-cut tube to be used as an anchor and tension wire according to one embodiment of the present invention. [Figure 12] Figure 11 is a top view of the laser-cut anchor in its assembled state. [Figure 13] Figure 11 is a top view of a laser-cut anchor having an exemplary frame of an artificial valve in its assembled and operating state. [Figure 14] This is a top view of an exemplary anchor / docking device with an end hook. [Figure 15] This is a schematic diagram of another exemplary anchor / docking device having a high-friction cover layer. [Figure 16] This is a schematic diagram of yet another exemplary anchor / docking device having a friction element. [Figure 16A] This is a cross-sectional view of the embodiment shown in Figure 16. [Figure 17] This is a schematic diagram of an exemplary anchor / docking device incorporating both a high-friction coating and friction elements. [Figure 18]This figure shows an exemplary anchor / docking device having a special surface mechanism to facilitate interlocking or positioning between adjacent coils. [Figure 19] This figure shows an exemplary anchor / docking device, which is a modified example of the anchor in Figure 10. [Figure 19A] This is a cross-sectional view of an exemplary embodiment of an anchor / docking device. [Figure 20] This is a schematic top view of an embodiment of an anchor / docking device implanted and positioned at a potential location in the natural mitral valve loop. [Figure 21] Figure 19 shows an anchor, further including an exemplary marker band. [Figure 22] Figure 19 is a cross-sectional view of the proximal end of an example anchor. [Figure 22A] This figure shows an exemplary embodiment of a suture thread passed through an exemplary anchor / docking device in a loop. [Figure 22B] This figure shows an exemplary embodiment of a suture thread passed through an exemplary anchor / docking device in a loop. [Figure 22C] This figure shows an exemplary embodiment of a suture thread passed through an exemplary anchor / docking device in a loop. [Figure 23] This figure shows an exemplary end of the skeleton or core of an exemplary anchor / docking device. [Figure 24] This figure shows an exemplary end of the skeleton or core of an exemplary anchor / docking device. [Figure 25] This figure shows an exemplary end of the skeleton or core of an exemplary anchor / docking device. [Figure 26] This figure shows an exemplary end of the docking device of Figure 25, with a cover layer attached to the skeleton or core. [Figure 27A] A perspective view of an exemplary embodiment of an exemplary anchor / docking device having an exemplary spherical tip including an axially aligned retrieval line / suture opening. [Figure 27B] This figure shows a cross-section of the spherical proximal tip of Figure 27A attached to the anchor / docking device. [Figure 27C] Figures 27A and 27B show the spherical tip and the wire / suture threaded through the delivery device in a loop. [Figure 27D] Figure 27A is a perspective view of the spherical tip. [Figure 27E] Figure 27A is a cross-sectional view of the proximal tip of the spherical structure. [Figure 27F] Figure 27A is an end view of the spherical tip. [Figure 27G] Figure 27A is a perspective view of an exemplary embodiment of the spherical tip, in which the distal region of the tip forms the same plane as the coiled anchor. [Figure 28A] A perspective view of an exemplary embodiment of an exemplary anchor / docking device having an exemplary spherical tip including an axially aligned retrieval line / suture opening. [Figure 28B] This figure shows a cross-section of the spherical proximal tip of Figure 28A attached to the anchor / docking device. [Figure 28C] Figures 28A and 28B show the spherical tip and the wire / suture threaded through the delivery device in a loop. [Figure 28D] Figure 28A is a cross-sectional view of the proximal tip of the spherical structure. [Figure 28E] Figure 28A is an end view of the spherical tip. [Figure 28F] Figure 28A is a perspective view of an exemplary embodiment of the spherical tip, in which the distal portion of the tip forms the same plane as the coiled anchor. [Figure 29A] A perspective view of an exemplary anchor / docking device having an exemplary loop-shaped tip. [Figure 29B] This is a side view of the line / suture threaded in a loop at the tip of Figure 29A. [Figure 29C] This figure shows the tip of Figure 29A in its pre-folded state. [Figure 29D] Figure 29C is a view of the pre-folded tip end. [Figure 29E]Figure 29A is a top perspective view of the proximal tip of the loop-shaped structure. [Figure 30A] This is a perspective view of an exemplary anchor / docking device end, including a recessed groove and connecting line / suture at the proximal end. [Figure 30B] Figure 30A is a side view of the retrieval line / suture connected to the connecting line / suture in a recessed groove of an exemplary anchor / docking device. [Modes for carrying out the invention]

[0040] This specification discloses various anchor or docking devices (e.g., coiled anchors or docking devices) that can be used with transcatheter heart valves (THVs) expandable at the site of a natural valve loop (e.g., mitral valve loop or tricuspid valve loop) to more securely implant and retain a prosthetic valve at the implantation site. The fixation / docking devices according to embodiments of the present invention constitute or form a more circular and / or more stable valve loop at the implantation site, and at the implantation site, a prosthetic valve having a circular or cylindrical valve frame or stent can be expanded or otherwise implanted. The fixation / docking devices can have a size and shape that not only constitutes a fixation site for the prosthetic valve but also constricts or pulls the natural valve (e.g., mitral valve, tricuspid valve, etc.) biostructure radially inward. In this way, it is possible to at least partially offset or counteract one of the main causes of valve regurgitation (e.g., functional mitral regurgitation), particularly hypertrophy of the heart (e.g., left ventricle) and / or valve loop, and thus stretching from the natural valve (e.g., mitral valve) loop. Some embodiments of the fixation or docking device further include special mechanisms shaped and / or modified to better maintain the position or shape of the docking device during and / or after expansion of the artificial valve within the docking device. By providing such a fixation or docking device, the replacement valve can be more reliably implanted and held in various valve loop locations, including in the location of the mitral valve loop, which does not have a natural circular cross-section.

[0041] Exemplary anchor / docking devices are shown in Figures 3 to 5. Figure 3 shows a perspective view of anchor or docking device 1, Figure 4 shows a side view of anchor / docking device 1, and Figure 5 shows a top view of anchor / docking device 1. The anchor / docking device can be coiled (for example, including a coiled portion) as shown in these figures.

[0042] The docking device 1 includes a coil having multiple windings extending along the central axis of the docking device 1. The coil can be continuous, extend generally in a helical manner, and have cross-sections of various different sizes and shapes, as will be described in more detail below. The docking device 1 shown in Figures 3 to 5 is configured to fit best to the mitral position, but in other embodiments, it can be shaped similarly or differently to better accommodate other natural valve positions.

[0043] The docking device 1 includes a central region 10 having approximately three full coil turns with substantially equal inner diameters. The central region 10 of the docking device acts as the primary loading or retaining region for holding the expandable prosthetic valve or THV when the docking device 1 and the valve prosthesis are implanted in the patient's body. Other embodiments of the docking device 1 may have a central region 10 with more or fewer coil turns, depending on the patient's biostructure, the desired amount of vertical contact between the docking device 1 and the valve prosthesis (e.g., THV), and / or other factors. The coils in the central region 10 are sometimes referred to as “functional coils” because the properties of these coils contribute most to the amount of retaining force generated between the valve prosthesis, the docking device 1, and the natural mitral valve leaflets and / or other anatomical structures.

[0044] Various factors can contribute to the total retaining force between the docking device 1 and the prosthetic valve held within the docking device. The primary factor is the number of turns included in the functional coil, while other factors include, for example, the inner diameter of the functional coil, the frictional force between the coil and the prosthetic valve, the strength of the prosthetic valve, and the radial force exerted by the valve on the coil. The docking device can have a variety of coil turns. The number of functional turns can range from just over half a turn to five turns, or from one full turn to five turns, or more. In one embodiment of three full turns, an additional half turn is included in the ventricular portion of the docking device. In another embodiment, there can be a total of three full turns within the docking device. In one embodiment, in the atrial portion of the docking device, there can be from half a turn to three-quarters of a turn, or from half a circle to three-quarters of a circle. While a range of turns is provided, as the number of turns in the docking device decreases, the dimensions and / or material of the coil and / or the wire forming the coil can also be changed to maintain an appropriate retaining force. For example, the wire diameter can be larger than the diameter of the functional coil winding in a docking device with fewer coils. Multiple coils can be provided in the atria and ventricles.

[0045] The size of the functional coil or the coil of the central region 10 is generally selected based on the size of the desired THV to be implanted in the patient. Generally, the inner diameter of the functional coil / winding (e.g., the coil / winding of the central region 10 of the docking device 1) is smaller than the outer diameter of the expandable heart valve, thereby, when the prosthetic valve is expanded in the docking device, an additional radial tension or retaining force acts between the docking device and the prosthetic valve to hold the prosthetic valve in place. The retaining force required to properly implant the prosthetic valve varies based on the size of the prosthetic valve and the assembly's ability to cope with a mitral pressure of approximately 180 mmHg. For example, based on bench tests using a prosthetic valve with an expanded outer diameter of 29 mm, a retaining force of at least 18.5 N is required between the docking device and the prosthetic valve to reliably hold the prosthetic valve in the docking device and resist or prevent mitral regurgitation or leakage. However, in this example, to meet the 18.5 N retaining force requirement with statistical reliability, the target mean retaining force needs to be substantially increased, for example, to about 30 N.

[0046] In many embodiments, the retaining force between the docking device and the valve prosthesis is significantly reduced when the difference between the expanded outer diameter of the prosthetic valve and the inner diameter of the functional coil is less than approximately 5 mm. This is because this reduced size difference is too small to generate sufficient retaining force between the components. For example, in one embodiment, when a prosthetic valve with an expanded outer diameter of 29 mm is expanded within a set of coils having an inner diameter of 24 mm, the observed retaining force is approximately 30 N. However, when the same prosthetic valve is expanded within a set of coils having an inner diameter of 25 mm (e.g., just 1 mm larger), the observed retaining force drops significantly to 20 N. Therefore, for this type of valve and docking device, the inner diameter of the functional coil (e.g., the coil in the central region 10 of the docking device 1) must be 24 mm or less to generate sufficient retaining force between the docking device and the 29 mm prosthetic valve. Generally, the inner diameter of the functional coil (e.g., the central region 10 of the docking device 1) should be selected to be at least approximately 5 mm smaller than that of the prosthetic valve selected for implantation. However, since various factors can affect the retention force, if other sizes or size ranges are used, better retention can be achieved by using other special mechanisms and / or properties (e.g., friction-enhancing special mechanisms, material properties, etc.). Furthermore, as the size of the inner diameter of the functional coil or central region 10, a size that better attracts the mitral biostructure can be selected, for example, to at least partially counteract and at least partially counteract mitral regurgitation resulting from stretching of the natural valve loop as a result of left ventricular hypertrophy.

[0047] It should be noted that the desired retaining force described above is applicable to embodiments for mitral valve replacement. Therefore, other embodiments of the docking device used for replacing other valves may have different size relationships based on the desired retaining force for valve replacement at their respective locations. Furthermore, the size differences may vary based on, for example, the materials used for the valve and / or docking device, whether there are other special mechanisms to prevent expansion of the functional coil or to enhance friction / locking, and / or various other factors.

[0048] In embodiments where the docking device 1 is used at the mitral position, the docking device can first be advanced and delivered to the natural mitral valve loop, and then set to the desired position before implanting the THV. The docking device 1 is preferably flexible and / or made of a shape-memory material, thereby allowing the coil of the docking device 1 to be straightened so that it can also be delivered via a transcatheter technique. In another embodiment, the coil can be made of another biocompatible material, such as stainless steel. The same catheter and some of the other delivery devices can be used to deliver both the docking device 1 and the prosthetic valve without the need to perform separate preparation steps, simplifying the implantation procedure for the end user.

[0049] The docking device 1 can be advanced from the left atrium, transseptally through the atrial septum to the mitral position, or through one of a variety of other known access points or procedures. Figures 6 and 7 illustrate some steps in advancing the docking device 1 to the mitral position using the transseptal approach, advancing the guide sheath 1000 through the vascular system to the right atrium, through the atrial septum of the heart to the left atrium, and advancing the delivery catheter 1010 through the guide sheath 1000 through the vascular system, right atrium, and septum into the left atrium. As can be seen in Figure 6, the docking device 1 can be advanced into the left ventricle through the distal end of the delivery catheter 1010 positioned in the left atrium (for example, at the commissure), and through the natural mitral valve loop at the commissure of the natural mitral valve, for example. The distal end of docking device 1 then wraps around the mitral biostructure located in the left ventricle (e.g., the native mitral valve leaflets and / or chordae tendineae), thereby surrounding and gathering all or at least some of the native valve leaflets and / or chordae tendineae with the coil of docking device 1 and holding them within the coil (e.g., surrounded by the coil).

[0050] However, because the diameter of the functional coil / winding or coil / winding in the central region 10 of the docking device 1 is kept relatively small in order to increase the retention force of the prosthetic valve (for example, in one embodiment, the central region 10 may have an inner diameter of about 24 mm (e.g., ±2 mm) or another diameter smaller than the THV and / or natural valve loop), it may be difficult to advance the docking device 1 to the desired position relative to the natural mitral valve loop around the existing valve leaflets and / or chordae tendineae. This is especially true when the entire docking device 1 is made to have the same small diameter as the central region 10. Therefore, referring again to Figures 3 to 5, the docking device 1 may have a distal region or lower region 20 that constitutes the guide coil / winding (or atoventricle coil / winding) of the docking device 1, and the guide coil / winding has a diameter larger than the diameter of the functional coil / winding or coil / winding in the central region 10.

[0051] The special mechanism of the mitral biostructure within the left ventricle has variable dimensions and can have a maximum width of approximately 35 mm to 45 mm along its long axis. Therefore, the diameter or width of the guide coil / winding (e.g., ventricular coil / winding) in the lower region 20 can be selected to be larger in order to more easily manipulate the distal tip or guide tip 21 of the docking device 1 and to rotate around the special mechanism of the mitral biostructure (e.g., valve leaflets and / or chordae tendineae). Various sizes and shapes are possible, and for example, in one embodiment, the diameter can be any size from 25 mm to 75 mm. The term “diameter” as used in this disclosure does not require the coil / winding to be a perfect circle and is generally used to refer to the maximum width between opposing points of the coil / winding. For example, with respect to the guide coil / winding, the diameter can be measured from the distal tip 21 to the opposite side, as in the case where the distal lower region 20 or the guide coil / winding forms a perfect rotation, or the diameter can be considered to be twice the radius of curvature of the guide coil / winding. In one embodiment, the lower region 20 of the docking device 1 (e.g., the guide coil / winding) has a diameter (e.g.,) of approximately 43 mm (e.g., ±2 mm), in other words, the radius of curvature in the guide coil / winding can be approximately 21.5 mm. Making the size of the guide coil / winding larger than the functional coil can help guide the coil more easily around and / or inside the chordae tendineae, and most importantly, it can help guide it properly around both natural leaflets of the mitral valve. After the distal tip 21 has manipulated around the desired mitral biostructure, the remaining coils of the docking device 1 can also guide around the same special mechanism, and because the size of the other coils is made smaller, the surrounded biostructure special mechanism can be pulled slightly radially inward. On the other hand, the length of the enlarged lower region 20 is generally kept relatively short to prevent or avoid obstruction or interference of blood flow along the left ventricular outflow duct by the lower region 20. For example, in one embodiment, the enlarged lower region 20 extends over approximately half a loop or turn.Because the lower region 20 has this relatively short length, as the prosthetic valve expands into the docking device 1, the coil of the docking device 1 begins to unwind slightly due to the size difference between the docking device and the prosthetic valve, and the lower region 20 is also retracted and slightly shifted. In this example, after the expansion of the prosthetic valve, instead of continuing to protrude from the functional coil, the lower region 20 can become similar in size to the functional coil of the docking device 1 and substantially match the functional coil, thereby reducing potential blood flow obstruction. Other docking device embodiments may have longer or shorter lower regions depending on the specific application.

[0052] The docking device 1 in Figures 3-5 also includes an enlarged proximal or upper region 30 that constitutes the stabilizing coil / winding of the docking device 1 (which may be, for example, an atrial coil / winding). Once the docking device 1 is positioned in the desired location and orientation at the natural mitral valve loop, the entire docking device 1 is released from the delivery catheter 1010, and the prosthetic valve (e.g., THV) is then delivered to the docking device 1. During the transition or intermediate stages of the implantation procedure, i.e., from the deployment and release of the docking device 1 until the final delivery of the prosthetic valve, the coil may shift from its desired location or orientation, and / or become dislodged, for example, due to normal cardiac function. If the docking device 1 shifts, in some cases the implantation may become unsafe, resulting in displacement and / or other placement problems with the prosthetic valve. Special stabilization mechanisms or coils may be used to help stabilize the docking device in the desired location. For example, the docking device 1 may be positioned within the circulatory system (e.g., within the left atrium) and may include an upper region 30 having an enlarged stabilizing coil / winding (e.g., an enlarged atrial coil / winding) that can thereby stabilize the docking device. For example, the proximal or upper region 30 or the stabilizing coil / winding may be configured to abut against or press against the wall of the circulatory system (e.g., the wall of the left atrium) to improve the ability of the docking device 1 to remain in the desired position before the prosthetic valve is implanted.

[0053] In the illustrated embodiment, the stabilizing coil / winding (e.g., atrial coil / winding) in the upper region 30 of the docking device 1 extends over nearly a complete turn or rotation and terminates at the proximal tip 31. In other embodiments, the stabilizing coil / winding (e.g., atrial coil) can extend over more or fewer turns or rotations, depending, for example, the desired amount of contact between the docking device and the circulatory system (e.g., the wall of the left atrium) depending on each specific application. The radial size of the stabilizing coil / winding (e.g., atrial coil) in the upper region 30 can be significantly larger than the size of the functional coil in the central region 10, thereby allowing the stabilizing coil / winding (e.g., atrial coil) to spread or extend sufficiently outward to contact the wall of the circulatory system (e.g., the wall of the left atrium). For example, in one embodiment, the major axis 32 or width of the upper region 30 is about 50 mm (e.g., ±2 mm), or about twice the size of the coil in the central region 10. The bottom region of the left atrium generally narrows towards the natural mitral valve loop. Therefore, when the docking device 1 is properly deployed in the mitral position, the stabilizing coil / winding in the upper region 30 (e.g., the atrial coil) contacts and presses against the left atrial wall, helping to maintain or hold the docking device 1 in a relatively high desired position and orientation, preventing or reducing displacement of the docking device 1 toward the left ventricle until the THV is advanced to the docking device 1 and expanded within the docking device 1. After the prosthetic valve (e.g., the THV) is expanded within the docking device, the forces generated between the functional coil and the prosthetic valve (e.g., by the tissue, leaflets, etc. between the functional coil and the prosthetic valve) are sufficient to fix and stabilize the docking device and the prosthetic valve without the need for stabilizing coils / winding.

[0054] In some cases, the stabilizing coil / winding in the upper region 30 (e.g., atrial coil) is non-circular and, in the illustrated embodiment, is off-center and arranged in an elliptical or oval shape. As shown in Figure 5, the elliptical or other non-circular stabilizing coil / winding (e.g., atrial coil) may have a major axis 32, D1 (i.e., maximum width of the coil winding), a minor axis 33, and D2 (i.e., minimum end-to-end width). The width / diameter may be selected based on the size of some biostructure of the circulatory system (e.g., based on the size of the human left atrium). The major axis (or maximum width) D1 may range from 40 mm to 100 mm, or from 40 mm to 80 mm or from 40 mm to 75 mm. The minor axis (or minimum width) D2 may range from 20 mm to 80 mm or from 20 mm to 75 mm. The major axis / width D1 of the stabilizing coil / winding (e.g., atrial coil) can be approximately 50 mm, while the diameter / width D2 along the minor axis of the stabilizing coil / winding (e.g., atrial coil) can be much smaller, for example, slightly larger than the diameter of the central region 10 of the docking device 1, as can be best seen in the top view of the docking device 1 in Figure 5. In other embodiments, the upper region of the docking device can be offset in many ways. For example, the stabilizing coil / winding (e.g., atrial coil) in the upper region 30 can remain substantially circular, and / or the stabilizing coil / winding can be offset in one direction, thereby offsetting the center of the upper region from the center of the other part of the docking device. Offsetting the shape of the upper region 30 of the docking device 1 in this way can increase contact between the docking device 1 and the wall of the left atrium or other biological structure in the radial direction where the upper region 30 extends furthest from the other part of the docking device 1. The stabilizing coil / winding (e.g., an atrial coil) can be offset so that, when viewed from above (Figure 20), its center is offset from the center of the functional coil by approximately 50% to 75% of the functional winding's diameter. The stabilizing winding of the coil (e.g., an atrial winding) can be made flexible and bend inward.This allows the biological structure (e.g., the left atrial biological structure) to be housed, and the stabilizing coil / winding (e.g., the atrial coil) may have a larger major or minor axis than the atrium or other biological structure itself.

[0055] Importantly, the docking device 1 can be rotated or otherwise oriented so that the narrower portion of the upper region 30, or at least the portion extending radially outward, is oriented in an optimal manner. For example, when implanted in a natural mitral valve, it can be oriented toward the left atrial wall that is opposed to or pressed against the left ventricular outflow duct, thereby reducing the amount of pressure applied by the docking device 1 to that portion of the atrial wall. In this way, the displacement of that portion of the wall toward the left ventricular outflow duct is also reduced, and therefore the enlarged upper region 30 can avoid obstruction, interference, or, in some cases, impact on blood flow through the left ventricular outflow duct.

[0056] The enlarged upper region 30 allows the docking device 1 to be more securely held in the correct position and orientation at the natural valve loop (e.g., the natural mitral valve loop) before the THV is implanted and expanded within the docking device 1. Such self-retention of the docking device 1 more effectively prevents any undesirable tilting or tilting of the docking device 1 before the prosthetic valve is fully implanted, thereby improving the performance of the implant as a whole.

[0057] Figures 6–9 show some of the steps that can be used to deliver and implant a docking device (e.g., docking device 1 or other docking devices described elsewhere herein) and a THV at the mitral position. Although these are intended for the mitral position, similar steps can be used for other valve positions, such as the tricuspid valve position. The docking device can be docking device 1 described above with respect to Figures 3–5 or another similar docking device (e.g., other docking devices herein), and the THV is generally a self-expandable, mechanically expandable, or balloon-expandable THV (or a combination thereof) having a circular or cylindrical valve frame or stent that is sized to expand and be held within the docking device.

[0058] Figures 6 and 7 illustrate a transseptal procedure for delivering the docking device 1 to the patient's mitral position, advancing the guide sheath / introducer 1000 across the cardiac atrial septum and advancing the distal end of the delivery catheter 1010 through the guide sheath 1000 so that the distal opening of the delivery catheter is positioned in the left atrium to deliver the docking device 1. In some cases, the delivery catheter can be similarly advanced and positioned through biostructures (e.g., the vascular system, cardiac chambers, septum, etc.) without first inserting or using a guide sheath. In an exemplary procedure, the guide sheath 1000 (and / or delivery catheter 1010) is introduced into the patient's venous system, for example by percutaneous puncture or a small incision in the patient's groin, and then the guide sheath 1000 (and / or catheter 1010) is advanced through the patient's vascular system to the left atrium, as shown in Figures 6 and 7. It should be noted that the transseptal procedure shown in the illustration is merely one example, and various alternative procedures and / or access sites can be used to deliver the docking device 1 and / or a suitable prosthetic valve to the mitral position or other locations in the heart. However, transatrial or transseptal procedures may be preferred because they allow for a clearer entry into the left side of the heart compared to other procedures, such as transapical procedures or other procedures where access to the mitral valve is made through the left ventricle, thereby allowing the physician to avoid direct interference with chordae tendineae and other ventricular obstructions.

[0059] As shown in Figure 6, the distal end of the delivery catheter 1010 is positioned directly above the plane of the natural valve (e.g., the mitral plane), and the delivery catheter 1010 is advanced to a position within the left atrium where this distal end can be positioned, for example, near the commissure of the natural valve. The delivery catheter can be made manipulable in multiple dimensions (e.g., more than two dimensions) to allow for more precise positioning. The positioning of the distal opening of the delivery catheter determines the access site for implanting the docking device 1 in the mitral position. The access site is typically near one of the two commissures of the natural mitral valve, thereby allowing the lead tip 21 of the docking device 1 to be advanced into the left ventricle through the natural valve commissure, deploying the lead coil / winding of the lower region 20 (e.g., the ventricular coil), as well as at least a portion of the functional coil / winding (e.g., the coil / winding of the central region 10), into the left ventricle. In one deployment method, the leading tip 21 of the docking device 1 is first guided through the commissure A3P3 of the natural mitral valve, and then the remaining portion of the docking device 1 is advanced from the delivery catheter through the commissure A3P3.

[0060] While the docking device 1 is held within the delivery catheter 1010, it can be straightened to facilitate manipulation of the docking device 1 through the delivery catheter 1010. By rotating, pushing, or, in some cases, advancing the docking device 1 from the delivery catheter 1010, the docking device 1 can return to its original coiled or curved shape, and as the docking device 1 is further advanced from the delivery catheter, the lead tip 21 advances clockwise or counterclockwise (i.e., viewing the valve loop in the direction of blood outflow) around various special mechanisms of the mitral biostructure, based on the curvature direction of the docking device 1 when it exits the delivery catheter (e.g., around). The enlarged lead coil / winding (e.g., ventricular coil / winding) at the lower region 20 of the docking device 1 facilitates the manipulation of the lead tip 21 of the docking device 1 around the mitral biostructure in the left ventricle. In the example above, if the lead tip 21 of docking device 1 enters the left ventricle through commissure A3P3 and advances clockwise when viewing the valve loop in the outflow direction (e.g., from atrium to ventricle), docking device 1 can first encircle the posterior leaflet of the natural mitral valve. An alternative method is also available to encircle the posterior leaflet first, for example, by inserting the lead tip 21 through commissure A1P1 and then advancing the docking device counterclockwise.

[0061] In some situations, encircling the posterior leaflet of the spontaneous mitral valve first may be easier than encircling the anterior leaflet first. This is because the posterior leaflet is located closer to the ventricular wall, which constitutes a more limited space from which the lead tip 21 can advance. Therefore, the lead tip 21 of the docking device 1 can use the ventricular wall near the posterior leaflet as a pathway or guide for advancing around the posterior leaflet. Conversely, when advancing the lead tip 21 of the docking device 1 and attempting to capture the anterior leaflet of the spontaneous mitral valve first, there is no ventricular wall nearby in that direction that can facilitate or guide the advancement of the lead tip 21. Therefore, in some situations, it may be more difficult to properly initiate circling around the mitral biostructure when manipulating the lead tip 21 to capture the anterior leaflet first rather than the posterior leaflet.

[0062] For this reason, depending on the procedure, it may still be preferable or necessary to encircle the anterior valve leaflet first. Furthermore, in many situations, it may be much easier to curve the distal end of the delivery catheter 1010 counterclockwise so that the docking device can be advanced. Thus, the method of delivery of the docking device can be adjusted accordingly. For example, the docking device may have a coil / winding that spirals or rotates in the opposite counterclockwise direction (see, for example, Figure 10 below), and the delivery catheter 1010 is also wound counterclockwise. In this way, such a docking device can be advanced into the left ventricle, for example, through the commissure A3P3, in a counterclockwise direction when viewing the valve loop in the outflow direction (e.g., from the atrium to the ventricle), rather than in the clockwise direction described above.

[0063] The amount of the docking device to be advanced into the left ventricle varies depending on the specific application or procedure. In one embodiment, most (if not all) of the coils / winding in the lower region 20 and the coils / winding in the central region 10 are advanced and placed in the left ventricle. In another embodiment, all of the coils / winding in the central region 10 are advanced into the left ventricle. In yet another embodiment, the docking device 1 is advanced to a position where the lead tip 21 is located posterior to the anteromedial papillary muscle. This position allows for a more secure fixation of the lead tip 21, and therefore a more secure fixation of the docking device 1. This is because the lead tip 21 is positioned and held between the chordae tendineae and the ventricular wall in that region. On the other hand, further advancement of the docking device 1 after any portion of the mitral biostructure has been surrounded and / or captured by the lead tip 21 helps to collect the captured chordae tendineae and / or valve leaflets within the coils of the docking device 1. Both ensuring the secure positioning of the lead tip 21 and preserving the natural mitral biostructure with the docking device 1 can help prevent obstruction of the left ventricular outflow duct (e.g., the aortic valve) before implantation of the THV.

[0064] After advancing the desired amount of docking device 1 into the left ventricle, the remaining portion of docking device 1 is deployed or released into the left atrium. Figure 7 shows one method of releasing the atrial portion of docking device 1 into the left atrium. In Figure 7, the distal end of the delivery catheter 1010 is rotated posteriorly or retracted, while docking device 1 is maintained in substantially the same position and orientation until the entire docking device 1 is released from the delivery catheter 1010. For example, if docking device 1 is advanced clockwise through commissure A3P3, the distal end of the delivery catheter 1010 can then be rotated counterclockwise or retracted to release the atrial portion of docking device 1. In this way, there is no need to adjust or readjust the ventricular position of docking device 1 during or after releasing the atrial portion of docking device 1 from the delivery catheter 1010. Various other methods can also be used to release the atrial portion of docking device 1. Before releasing the stabilizing coil / winding (e.g., an atrial coil) from the delivery catheter, the stabilizing coil / winding can be held in place and / or retracted / recovered by a retaining device / anchor (e.g., by securing it to a release / recovery line connected by a barb, Velcro® hook, latch, lock, anchor, etc., which can be screwed into the delivery device). The docking device does not tightly engage with the natural mitral valve after release (i.e., the docking device is loosely positioned around the natural mitral valve leaflets).

[0065] After the docking device 1 is fully deployed and adjusted to the desired position and orientation, the delivery catheter 1010 can be removed to make space for another delivery catheter for delivering the THV, or, in some embodiments, the delivery catheter 1010 can be adjusted and / or repositioned if an artificial valve is to be delivered through the same catheter 1010. In some cases, the guide sheath 1000 can be left in place, and after the delivery catheter 1010 is removed, the artificial valve or THV delivery catheter can be inserted through the same guide sheath 1000 and advanced within the guide sheath 1000. Figure 8 shows a cross-sectional view of a portion of the patient's heart before delivering the THV, with the docking device 1 of Figures 3-5 positioned in the mitral position. Here, the enlarged upper region 30 of the docking device 1 can be pressed against the atrial wall to help hold the docking device 1 in the desired orientation, and as described above, the upper region 30 can be deflected so that it is not pressed against the wall, which may lead to obstruction of the left ventricular outflow duct.

[0066] Furthermore, it should be noted that in at least some procedures, the valve leaflets are not substantially constrained by the docking device from the time the docking device 1 is delivered to the mitral position as described above until the prosthetic valve is implanted within the docking device 1, allowing the natural mitral valve to continue functioning substantially normally and the patient to maintain a stable condition. Therefore, the procedure can be performed on a beating heart without the need for cardiopulmonary support. Moreover, this provides physicians with greater temporal flexibility to implant valve prostheses without the patient being in a hemodynamically degraded position, or at risk of falling into such a position, if an excessive amount of time elapses between the implantation of the docking device 1 and the subsequent implantation of the valve.

[0067] Figure 9 shows a cross-sectional view of a portion of the heart where both the docking device 1 and the prosthetic valve 40 (e.g., THV) have ultimately been implanted in the mitral position. Generally, the prosthetic valve 40 has an expandable frame structure 41 that accommodates a number of valve leaflets 42. The expandable frame 41 of the prosthetic valve 40 can be balloon expandable or expandable by other means; for example, the frame can be self-expanding or mechanically expandable, or expandable by a combination of several methods. The prosthetic valve 40 can be delivered through the same catheter 1010 used to deliver the docking device 1, or generally, it can be introduced through a separate catheter while the valve 40 is radially folded to allow for easier manipulation through the delivery catheter. In some cases, the guide sheath can be left in place when the catheter 1010 is removed, allowing a new prosthetic valve or THV delivery catheter to be advanced through the guide sheath 1000. Next, the artificial valve 40 can be advanced from the delivery catheter while still in a folded state and positioned through the docking device 1, and then the artificial valve 40 can be expanded within the docking device 1, thereby holding the entire assembly in place in the mitral position by radial pressure or tension between its components. The mitral valve leaflets (or a portion of the mitral valve leaflets) can be sandwiched between the functional windings of the anchor or docking coil and the frame 41 of the artificial valve. After the docking device and artificial valve have been securely deployed / implanted, the remaining delivery device can be removed from the patient.

[0068] Figure 10 shows a perspective view of an exemplary anchor or docking device 1. The docking device 100 in Figure 10 has a central region 110, a lower region 120, and an upper region 130, which may be the same as or similar to the central region 10, lower region 20, and upper region 30 of the docking device 1 described above. The docking device 100 may include the same or similar special mechanisms and characteristics as described with respect to the docking device 1, and may be ported using the same or similar steps. However, the docking device 100 includes an additional extension 140 that is substantially located between the central region 110 and the upper region 130. In some embodiments, the extension 140 may be located, for example, entirely in the central region 110 (for example, above the central region 110) or entirely in the upper region 130. In Figure 10, the extension 140 consists of or includes a vertical portion of a coil that extends substantially parallel to the central axis of the docking device 100. In some embodiments, the extension portion 140 can be angled with respect to the central axis of the docking device 100, but generally, it acts as a vertical or axial spacer that separates adjacent connection portions of the docking device 100 vertically or axially, thereby creating a vertical or axial gap between the coil portions on each side of the extension portion 140 (for example, a gap can be created between the upper or atrial side and the lower or ventricular side of the docking device 100).

[0069] The stretch portion 140 of the docking device 100 is positioned through (for example, across) or near the natural valve loop to reduce the amount of the docking device 100 that passes through, presses against, or leans against the natural valve loop when the docking device 100 is implanted. This can, in some cases, reduce the stress or strain applied to the natural mitral valve by the docking device 100. In one configuration, the stretch portion 140 is positioned at one of the commissures of the natural mitral valve, passing through or crossing this commissure. In this way, the stretch portion 140 can separate the upper region 130 from the natural mitral valve leaflets, preventing the upper region 130 from interacting with or engaging with the natural valve leaflets from the atrial side. The extension portion 140 also raises the position of the upper region 130, thereby raising or moving away the contact point between the upper region 130 and the atrial wall from the natural valve, thereby reducing stress on and around the natural valve, for example, and ensuring more secure positioning of the docking device 100. The extension portion 140 can be in the range of 5 mm to 100 mm in length, and in one embodiment it is 15 mm.

[0070] The docking device 100 may further include one or more through-holes 150 at or near one or both of its proximal and distal ends. The through-holes 150 can serve, for example, as suture holes for attaching a cover layer onto the coil of the docking device 100, and / or as attachment points for delivery devices such as pushers, retaining devices / anchors (for example, to hold the docking device and / or to allow the device to be retracted and retrieved after it has been fully or partially deployed from the delivery catheter), or pull wires / sutures for other advancing or retaining devices. In some embodiments, the width or thickness of the coil of the docking device 100 may also vary along the length of the docking device 100. For example, among several reasons, the central region of the docking device 100 can be made slightly thinner than the end regions (not shown) of the docking device 100, thereby, for example, making the central region more flexible and the end regions more rigid or rigid, and / or the end regions having a larger surface area for sewing or otherwise attaching a cover layer to the coil of the docking device 100. In one embodiment, all or part of the stretch portion 140 can have a thinner thickness than the thickness of other regions of the docking device, for example, the stretch portion 140 can be thinner than, for example, the induction coil / winding or lower region 120, thinner than the functional coil / winding or central region 110, and / or thinner than the stabilizing coil / winding or upper region 130, as shown in Figure 19, for example.

[0071] In Figure 10 (and similarly in Figure 19), the coil of docking device 100 is shown to be wound in the opposite direction to the coil in docking device 1 described above. Thus, docking device 100 is configured to be inserted into the natural valve loop in a counterclockwise direction when viewing the valve loop in the blood outflow direction (e.g., from atrium to ventricle), as shown in the illustration. This advancement can be made through commissure A3P3, commissure A1P1, or another portion of the natural mitral valve. Positioning docking device 100 in a counterclockwise direction also allows the distal end of the delivery catheter to be bent in a counterclockwise direction, which in many examples is easier than bending the delivery catheter in a clockwise direction. Various anchor / docking device embodiments described herein (including anchor / docking devices 1, 100, 200, 300, 400, 500, 600, and 1100) can be configured for clockwise or counterclockwise advancement through one of various access points (e.g., any of the commissures).

[0072] In most situations and patients, the docking device needs to be positioned high relative to the native mitral valve (e.g., further away within the left atrium). Considering the mitral biostructure, the docking-valve combination that will ultimately be assembled needs to be positioned high, and in some cases as high as possible, at the native valve to anchor the valve to the clear zone of the native mitral leaflets. Furthermore, in a healthy human heart, the native mitral leaflets are generally smoother above the junction (e.g., above the area where the leaflets converge when the mitral valve is closed) and rougher below the junction. The smoother areas or zones of the native leaflets have a much higher collagen content and are stronger, thereby providing a more secure anchoring surface for the prosthetic valve than the rougher areas or zones. Therefore, in most cases, the docking device needs to be positioned as high as possible at the native valve during insertion and must have sufficient retention force to anchor the prosthetic valve or THV. For example, the length of the coil in a docking device placed within the ventricle is generally determined by the number of turns within the ventricle and the thickness of the wire used. Generally, as the wire used becomes thinner, the length required within the ventricle to provide sufficient retention increases. For example, if the docking device coil is 370 mm long, approximately 280 mm (e.g., ±2 mm) will be placed within the ventricle. Approximately 70-90 mm will be placed within the atrium, and approximately 10-15 mm will be used in the transition or extension length to move the docking device coil away from the plane of the mitral valve on the atrial side of the docking device.

[0073] The average mitral valve in humans is approximately 50 mm along its long axis and 38 mm along its short axis. Due to the size and shape of the natural valve, and usually the smaller size of the replacement valve, an inverse relationship is formed between how high the docking device can be positioned in the mitral position and the retaining force that the docking device can exert on the THV to be implanted, with respect to the coil diameter of the docking device. Docking devices with larger diameters can capture more chordae tendineae and therefore have the ability to deploy higher relative to the natural valve, but the retaining force on the valve to which the docking device is docked will be weaker. Conversely, docking devices with smaller diameters can exert a stronger retaining force on the valve to which they are docked, but may not be able to capture as many chordae tendineae when positioned, which may result in a lower position of the docking device in the natural valve loop. On the other hand, larger docking devices can be modified to have a larger coil diameter or thickness, and / or can be constructed using materials with a higher modulus of elasticity.

[0074] Figures 11-13 show a docking device according to another embodiment of the present invention. The docking device 200 (see Figures 12 and 13) comprises a laser-cut tube 210 and a tension wire 219. The wire 219 can be used to adjust the curvature and / or size of the docking device 200. For example, the docking device 200 can take on a larger or wider configuration when positioned at the location of the natural valve loop, and can therefore be adjusted by the wire 219 to take on a smaller or narrower configuration in preparation for docking an artificial valve.

[0075] Figure 11 schematically shows an open sheet diagram of a laser-cut tube 210, for example, the ends of the sheets can be connected to form a tubular structure, or a similar tube can be formed as a tube, i.e., seamlessly and cut as a tube. The tube 210 can be made from a shape memory material or a non-shape memory material (e.g., NiTi, stainless steel, other materials, or a combination of materials). The tube 210 can be laser-cut to have the pattern shown in Figure 11, or a similar pattern, and the cutting pattern indicates the shape of the docking device 200 when the docking device 200 is activated. The patterned cuts in Figure 11 extend transversely to the longitudinal axis of the tube 210 and include a plurality of separate cuts 211 that separate the tube 210 into a plurality of interconnected links 212. Each of the notches 211 may further form one or more teeth 213 and one or more corresponding grooves 214 in an adjacent link 212, and the teeth 213 may extend into the adjacent grooves 214, including when the tube 210 is bent or curved. The teeth 213 and grooves 214 formed by each notch 212 may extend in the same direction along the tube 210, or some may be configured to extend in opposite directions, depending on the desired shape of the docking device 200. The notches 211 are also included entirely on the sheet or tube, in other words, the notches 211 do not extend to any edge of the sheet or tube, thereby the links 212 remain interconnected with each other in at least one region. In other embodiments, some or all of the notches may extend to the edge of the sheet or tube, as needed. In the embodiment of Figure 11, each of the notches 211 further includes an end region 215 on each end of the notch 211 that extends parallel to the longitudinal axis of the tube 210. The end region 215 constitutes a space for adjacent links 212 to pivot relative to each other while remaining interconnected.

[0076] The laser-cut patterning can also be modified or altered along the length of the tube 210 so that the notches have different sizes, shapes, and positions on the sheet or tube, so that different shapes and curvatures are obtained in the docking device 200 when tension is applied to it or when the docking device 200 is actuated. For example, as can be seen in Figure 11, the left end of the sheet or tube includes another notch 216 that is larger than the notches 211 found in the central and right portions of the sheet or tube (as shown in the figure). The left end of the tube 210 may have such an enlarged laser-cut pattern to make the distal end of the docking device 200 more mobile or flexible, as will be described in more detail below.

[0077] Furthermore, the laser-cut sheet or tube may include one or more distal wire-locking special mechanisms, e.g., notches 217, at the distal or left end of the sheet or tube, as shown in the figure, and / or include one or more proximal wire-locking special mechanisms, e.g., notches 218, at the proximal or right end of the sheet or tube, as shown in the figure. Using either or both of the distal wire-locking special mechanisms 217 or the proximal wire-locking elements, the locking wire 219 shown in Figure 11A can be attached to the distal or proximal end of the tube 210, and tension can then be applied to the locking wire 219 through the tube 210 to lock it to the opposite end of the tube 210 and obtain the desired operating shape of the docking device 200. By arranging the laser-cut pattern along a large portion of the tube 210 or along the entire length of the tube 210, the tube 210 is forced into the desired final coil shape or form by the configuration of the notches 211 and 216 when the locking wire 219 is attached to one end of the tube 210 and then actuated to lock it to the other end of the tube 210. The tension in the tension wire has the ability to control the radially outward and inward forces applied on the docking device 200, as well as the radially outward and inward forces applied by the docking device 200 to other special mechanisms, such as the displacement valve 40 held within the docking device 200. The locking wire can help control the forces applied by the docking device, and in other embodiments, the locking wire is not required. The locking wire can be inserted into the laser-cut hypo tube, or the locking wire can be inserted into the non-laser-cut tube. Locking wires can be sutures, tethers, wires, strips, etc., and can be made from various materials such as metal, steel, NiTi, polymer, fiber, Dyneema, and other biocompatible materials.

[0078] In some embodiments, for example, embodiments in which the docking device 200 is assembled using a shape memory material such as NiTi, the tube 210 can be positioned around a round core that defines a desired coil diameter at the time of manufacture and its shaping at that particular diameter. In some embodiments, the shaping diameter can be larger than the desired final diameter of the docking device 200, thereby allowing the tube 210 to take on this larger shaping diameter when pushed out of the delivery catheter and before activating the locking wire or tension wire. During this time, the larger diameter of the docking device 200 can help to more easily manipulate and turn the docking device 200 around the biostructural shape of the natural valve.

[0079] Furthermore, in some embodiments, the distal end 222 of the tube 210 can be shaped differently so that, instead of following the same coil shape as the rest of the docking device 200, the distal end 222 flexes or articulates slightly radially outward compared to the rest of the docking device 200, as can be seen, for example in Figure 12, to further assist in turning around the mitral biomolecule or other valve biomolecule. In addition to or instead of the different shaping described above, the distal end 222 of the tube 210 can include different notches 216 to make the distal end 222 more flexible or mobile, and the notches 216 can assist in manipulating the distal end 222 of the docking device 200 around biomolecular shapes.

[0080] The docking device 200 is manipulated around the mitral biostructure or other biostructure shape, and after reaching a desired position relative to the natural valve, tension can be applied to the locking wire or otherwise actuated to reduce the size of the docking device (for example, by reducing the diameter of the coil windings) to allow for a firmer or more secure docking of the artificial replacement valve 40. On the other hand, in some embodiments in which the distal tip 222 of the docking device 200 is shaped to flex outward, the tension of the locking wire may, in some cases, pull or retract the distal tip 222 further inward, thereby allowing the distal tip 222 to more closely conform in shape to the rest of the docking device 200 and contributing more effectively to the docking of the replacement valve 40.

[0081] Subsequently, the replacement valve 40 can be positioned and expanded within the docking device 200. Figure 13 shows an example of the docking device 200 after being actuated by the locking wire and after the replacement valve 40 has been expanded within the docking device 200. The tension in the locking wire helps to more effectively maintain the desired shape and size of the docking device 200 and maintain a stronger holding force between the docking device 200 and the valve 40. The radially outward pressure applied to the docking device 200 by the valve 40 is counteracted by the radially inward pressure applied to the valve 40 by the tension wire or locking wire and the docking device 200, resulting in a stronger and more secure hold between these components. As can be seen further in Figure 13, the docking device 200 can more effectively maintain its shape and size, so that the radially inward pressure from the docking device 200 to the valve 40 can cause a flaring effect at the ends of the valve 40's frame, thereby achieving a much more secure hold between the docking device 200 and the valve 40.

[0082] The docking device 200 can be modified in various ways in other embodiments. For example, the docking device may be made from or contain a shape memory material other than NiTi, or in some embodiments, it may be made from a non-shape memory material such as stainless steel, other biocompatible materials, and / or a combination thereof. Furthermore, although the docking device 200 has been described above for use at the mitral valve, in other applications, a similar or slightly modified docking device may be used to dock a replacement valve at other natural valve sites, such as the tricuspid valve, pulmonary valve, or aortic valve.

[0083] The docking device 200 described above, and similar devices using tension wires or locking wires, can offer several advantages over other docking devices, such as those that do not use locking wires. For example, the locking wire gives the user the ability to control the amount of radially outward and inward forces applied by generating and adjusting tension in the locking wire, either on or by the docking device, without compromising the desired profile of the docking device, or the ability to deliver the docking device via a catheter or minimally invasive technique. Figure 11A shows a tension wire 219 that is held below or looped around the teeth 218, then pulled through the opening 217 and crimped at the opening 217 to set the shape of the docking device. Furthermore, the docking device becomes more flexible as the tube is laser-cut, making it possible to deliver the docking device through a catheter, where the bending radius may be relatively small at some locations.

[0084] In embodiments where shape memory material is used, the docking device can be shaped to include a coil / winding with a larger diameter to allow the coil to rotate more easily around the specific bio-structure while the docking device is being advanced and before tension is applied to the locking wire. Furthermore, the distal tip of the docking device can be further shaped to bend or deviate slightly outward to help it rotate around a much larger portion of the bio-structure shape while the docking device is being advanced and positioned. Furthermore, in some embodiments, for example, more material may be removed to form a larger cut, making the distal portion of the docking device much more flexible, thereby allowing the tip to be operated and manipulated more easily to rotate around each different cardiovascular bio-structure. Patterns can be laser-cut to make the force in one area weaker than the force in another area. The tube can be oval-shaped, i.e., the cross-sectional area of ​​the tube can be oval-shaped, thereby allowing the tube to be bent in a desired direction when force is applied. Tension wires can also be attached to both the proximal and distal ends of the tube to generate tension. An example cut pattern is shown, but other cut patterns are also possible.

[0085] Various mechanisms can be further incorporated into or added to one or more of the docking devices described herein (for example, docking devices 1, 100, 200, 300, 400, 500, 600, and 1100 herein) to strengthen the retaining force between the docking device and the replacement valve expanded within the docking device. Generally, coiled docking devices or coil-shaped docking devices have two open or free ends after implantation. When a THV or other replacement valve is expanded within the coil, the coil may partially unwind, increasing the diameter of the coil due to outward pressure applied by the valve expanding on the coil, and reducing the retaining force applied to the valve by the coil. Therefore, mechanisms or other special mechanisms can be incorporated into the docking device to prevent or reduce coil unwinding when a replacement valve is expanded within the coil, thereby strengthening the radial force and retaining force between the docking device and the valve. Such mechanisms can be incorporated without modifying the size and shape of the docking device, for example, by increasing the thickness of the coil or decreasing the diameter of the inner space formed by the coil, both of which would negatively affect the performance or ease of delivery of the docking device. For example, making the coil of the docking device itself thicker would increase the stiffness of the coil due to the increased thickness, making it more difficult to pass the docking device through the delivery catheter. On the other hand, making the diameter of the inner space formed by the coil excessively small may prevent the expandable valve from fully expanding due to the narrowing of the space.

[0086] A first alternative modification for ensuring sufficient retention between the docking device and the valve expanded within the docking device is shown in Figure 14. The docking device 300 in Figure 14 includes a main coil 310 (which may be similar in size and shape to one of the docking devices described above) and anchors 320 extending from two free ends of the coil 310. The anchors 320 are configured, for example, to be sized or shaped to embed themselves into the surrounding tissue (e.g., the atrial wall and / or ventricular wall) when the replacement valve is expanded within the docking device 300, or otherwise. The anchors 320 may be provided with barbs to promote internal growth after the anchors 320 have been embedded in the cardiac wall or other tissue. The anchors can be any of a number of different shapes and sizes. The anchors can extend from the ends or any area near the ends. In some cases, the anchors or barbs may also be positioned at various locations along the length and outer surface of the docking device.

[0087] During operation, when the docking device 300 is deployed in the mitral biostructure, after the docking device 300 is positioned through the mitral valve, one end of the docking device 300 is positioned in the left atrium, while the other end of the docking device 300 is positioned in the left ventricle. The shape and size of the coil 310 of the docking device 300 can be selected and optimized so that when the docking device 300 is advanced to the desired position, the ends of the coil 310 reliably contact the atrial and ventricular walls, respectively. Thus, the anchors 320 at the ends of the coil 310 can themselves be fixed within the respective cardiac walls. When the replacement valve is expanded within the coil 310, the free end of the coil 310 is held in place by the anchors 320 housed within the cardiac wall. Since the free end of the coil 310 is immobile when the replacement valve is expanded within the docking device 300, the coil 310 is prevented from unwinding, thereby increasing the radial force applied between the docking device 300 and the expanded valve, and improving the holding force between these components.

[0088] Figure 15 shows a schematic diagram of a portion of another modified docking device for improving the retention force between the docking device and the replacement valve. A portion of the three windings of the docking device 400 is shown in Figure 15. The docking device 400 includes a main coil or core 410, which can be made of, for example, a NiTi coil / core, or one or more of various other biocompatible materials, or a coil / core containing one or more of various other biocompatible materials. The docking device 400 further includes a coating 420 covering the coil / core 410. The coating 420 can be made of or contain a high-friction material, thereby increasing the amount of friction generated between the valve and the coating 420 when the expandable valve within the docking device 400 is expanded, thereby maintaining the shape of the docking device 400 and preventing or suppressing / resisting unwinding of the docking device 400. In addition to or instead of this, the coating can increase the amount of friction between the docking device and the natural valve leaflets and / or the prosthetic valve, helping to maintain the relative position of the docking device, valve leaflets, and / or the prosthetic valve.

[0089] The coating 420 is made of one or more high-friction materials placed on the coil wire 410. In one embodiment, the coating 420 is made of PET woven on an ePTFE tube or includes PET woven on an ePTFE tube, where the ePTFE tube acts as the core for the coating 420. The ePTFE tube core is porous and forms a cushioning, padded layer for the studs or other parts of the expandable valve frame, improving engagement between the valve and the docking device 400. Meanwhile, the PET layer generates additional friction against the natural valve leaflets when the prosthetic valve is expanded, and the studs or other parts of the valve frame apply outward pressure to the docking device 400. These special mechanisms work together to increase the radial force between the docking device 400 and the natural valve leaflets and / or prosthetic valve, thereby also increasing the retaining force and preventing the docking device 400 from unwinding.

[0090] In other embodiments, the coating 420 can be made from one or more other high-friction materials that similarly cover the coil 410. The material selected to make the coating 420 can also promote rapid internal growth of the tissue. Furthermore, in some embodiments, the outer surface of the frame of the replacement valve can be covered with a cloth material or other high-friction material to further increase the frictional force between the docking device and the valve, thereby further preventing or reducing the unwinding of the docking device. The friction generated by the coating can have a coefficient of friction greater than 1. The coating can be made of ePTFE and can be a tube that covers the coil and can be smooth or porous (or woven or have other structural special mechanisms that increase the accessible surface area as well as pores) to promote internal growth of the tissue. The coating can also have PET woven on the ePTFE tube when the ePTFE tube is smooth. The outermost surface of the coating or the outermost surface woven on the coating can be any biocompatible material that generates friction, such as biocompatible metal, silicone tubing, or PET. The pore size in the coating can range from 30 to 100 microns. In embodiments where a PET coating is present on ePTFE, the PET layer is not directly attached to the docking device coil, but merely to the ePTFE coating. The ePTFE tube coating can be attached to the docking device coil at the proximal and distal ends of the coating. The ePTFE tube coating can be laser-welded onto the coil, or radiopaque markers can be placed on the outside of the ePTFE tube coating or PET blade and crimped to the material to hold it in place relative to the coil.

[0091] On the other hand, in some embodiments, the docking device 400 may also include anchors similar to the anchors 320 described above to further enhance the retaining force, while other embodiments of the docking device may incorporate the coating 420 without further including any such additional end anchors. After the replacement valve is expanded within the docking device 400 and the resulting assembly begins to function as a composite functional unit, any internal tissue growth may also work to reduce the load on the composite valve and dock assembly.

[0092] The coating 420 may be added to any of the docking devices described herein (for example, docking devices 1, 100, 200, 300, 400, 500, 600, and 1100) and may cover all or part of the docking device. For example, the coating may be configured to cover only a functional coil, induction coil, stabilization coil, or a portion of one or more of these (for example, only a portion of the functional coil).

[0093] Figures 16 and 16A schematically illustrate a portion of another modified docking device that improves the retention force between the docking device and the replacement valve. As shown in the cross-sectional view of Figure 16A, the valve leaflet tissue 42 is corrugated to match a variable cross-section between the region of the coil 510 containing the friction elements 520 and the region of the coil 510 not containing the friction elements. This corrugated shape of the valve leaflet tissue 42 ensures that the tissue 42 is more securely confined between the docking device 1 and the valve frame 41. The docking device 500 in Figure 16 includes a main coil 510 and one or more discrete friction elements 520 spaced apart along the length of the coil 510. The friction elements 520 can be made from a cloth material or other high-friction material such as PET and can be formed as small bulges on the surface of the coil 510 or on another layer placed on top of the coil 510. In some embodiments, the coating 420 itself can be considered a friction element or can be configured to form one or more of the friction elements 520. In some embodiments, the friction element 520 is added in addition to the addition of a high-friction coating 530 similar to the coating 420 described above. An example of a docking device 500 in which both the high-friction coating 530 and the friction element 520 are applied to the main coil 510 is schematically shown in Figure 17.

[0094] When the expandable valve is expanded within the docking device 500, friction is generated between the valve frame and the friction element 520 and / or between the valve frame, the natural valve leaflets and the docking device, preventing or inhibiting / resisting the unwinding of the coil 510 of the docking device 500. For example, the friction element 520 engages with or otherwise extends into the cells defined by the frame of the expandable valve, and / or pushes the valve leaflet tissue into the cells of the expandable valve. Furthermore, when the valve is expanded within the docking device 500, each of the friction elements 520 can engage with adjacent windings of the docking device 500 above and / or below the friction element 520, and / or engage with one or more other friction elements 520 on adjacent windings of the docking device 500. By any or all of these such engagements, the docking device 500 inhibits or resists unwinding, thereby increasing the retaining force between the docking device 500 and the expanded valve.

[0095] Figure 18 schematically shows a portion of three windings of yet another modified docking device 600 that helps improve the retention force between the docking device and the replacement valve. The docking device 600 includes a coil 610 modified by one or more interlocking keyholes and key patterns spaced along the length of the coil 610. The keyholes and key patterns may be simple, for example, a rectangular groove or notch 618 and a complementary rectangular projection 622 as schematically shown in Figure 18, or may be made of different shapes and / or more complex patterns or may include different shapes and / or more complex patterns in other embodiments. Furthermore, in various embodiments, the grooves 618 and projections 622 may all be arranged in the same axial direction or in different axial directions. Keyholes and key patterns or other friction elements may be placed on the functional windings of the docking device.

[0096] When the expandable valve within the docking device 600 is expanded, the keyhole and key mechanism depend on the adjacent windings of the coil 610 that are in contact with each other, and on each winding that interlocks with adjacent windings of the coil 610 located above and / or below each winding when one or more of the projections 622 engage with the corresponding grooves 618. The interlocking of the grooves 618 and projections 622 prevents relative movement between the respective special mechanisms and, therefore, also prevents the coil 610 of the docking device 600 from being physically unwound. Thus, this configuration also serves to strengthen the radial force and the final retaining force between the docking device 600 and the replacement valve that is expanded within the docking device 600.

[0097] Figure 19 shows a perspective view of an exemplary anchor or docking device. The docking device 1100 in Figure 19 may have the same or similar structure as the docking device 100 in Figure 10 described above and may include any of the special mechanisms and characteristics described with respect to the docking device 100. The docking device 1100 may include a central region 1110, a lower region 1120, an upper region 1130, and an extension region 1140. The lower region 1120 and the upper region 1130 may form a larger coil diameter than the central region 1110, and the extension region 1140 may separate the upper region 1130 from the central region 1110 in the vertical direction, as also described above. The docking device 1100 may also be positioned or wound so that its advance into the left ventricle is performed counterclockwise when viewing the valve loop in the outflow direction (e.g., from atrium to ventricle). Other embodiments may instead facilitate clockwise advance and positioning of the docking device.

[0098] In the embodiment shown in Figure 19, the central coil / winding 1110 of the docking device 1100 also functions as a functional coil / winding, constituting the main docking site for the prosthetic valve or THV that expands within the docking device. The central winding 1110 is generally located in the left ventricle, while, if there is a small distal portion, as will be described in detail below, this distal portion extends into the left atrium through the natural valve loop. In embodiments where the THV has an expanded outer diameter of 29 mm, the central winding 1110 can have an inner diameter ranging from 20 mm to 30 mm, and in exemplary embodiments, the inner diameter can be about 23 mm (e.g., ±2 mm) to provide a holding force of about 16 N between the components, sufficient to stably hold the expanded THV within the docking device 1100 even under severe mitral pressure and to prevent the THV from shifting away from the docking device 1100.

[0099] On the other hand, the lower region 1120 of the docking device 1100 acts as a guide coil / wound (e.g., a ventricular encircling winding). The lower region 1120 includes the distal tip of the docking device 1100 and extends radially laterally from the central winding 1110 to capture some or all of the native leaflets and chordae tendineae and / or other mitral valve biostructures when the docking device 1100 is advanced into the left atrium. A native mitral valve exhibiting mitral regurgitation typically has an A2P2 distance of 35 mm and a commissure-to-commissure distance of 45 mm. Therefore, with a 29 mm THV, the small size of the THV, and thus the size of the central winding 1110, is smaller than the long axis of the mitral biostructure. Thus, the lower region 1120 is formed to have a larger size or profile compared to the central winding 1110 so that the docking device 1100 can be guided more easily around both native leaflets in the first place. In one example, the diameter of the lower region 1120 can be configured to be approximately the same as the distance measured between the commissures of the natural valve (e.g., 45 mm), so that the distal tip extends approximately that distance away from the exit of the delivery catheter while the docking device 1100 is being delivered.

[0100] The upper region 1130 of the docking device 1100 acts as a stabilizing coil / wind (e.g., an atrial coil / wind) that provides a self-retaining mechanism to the docking device 1100 during the transition phase from when the docking device 1100 is deployed at the natural valve until the THV is delivered. The left atrium generally forms a funnel shape, widening outward from the mitral valve loop and spreading away from the valve loop. The diameter of the upper region 1130 is selected such that it allows the upper region 1130 to fit into the left atrium at approximately the desired height and prevents the upper region 1130 from sliding or falling further toward the natural mitral valve loop after the desired position has been achieved. In one example, the upper region 1130 is formed to have a diameter of 40-60 mm, such as approximately 53 mm.

[0101] Furthermore, the shape and position of the upper region 1130 are selected such that, after the THV is deployed within the docking device 1100, the pressure applied by the upper region 1130 to the portion of the atrial wall adjacent to the aortic wall is minimized or eliminated. Figure 20 is a schematic top view of a portion of the heart, showing approximately the left atrium 1800 and the mitral valve 1810 located in its central region. The approximate location of the aorta 1840 is also schematically shown. Meanwhile, the docking device 1100 is delivered to the natural mitral valve 1810 at commissure A3P3 1820. Note that the upper region 1130 of the docking device 1100 is positioned away from the wall 1830 of the left atrium 1800 adjacent to the aorta 1840. Furthermore, when the THV expands within the docking device, the central region 1110 of the docking device 1100 tends to expand and unwind slightly, thereby causing the upper region 1130 to be further pulled away from the atrial wall 1830 (counterclockwise downward, as shown in Figure 20). Further details regarding the placement of the docking device 1100 relative to the mitral valve 1810 are described below with further reference to Figure 20.

[0102] The stretch region 1140 results in vertical stretching and separation between the central region 1110 and the upper region 1130 of the docking device 1100. Therefore, in some embodiments, the stretch region 1140 of the docking device 1100 (and the stretch region 140 of the docking device 100) may be referred to as an ascending fold. The position where the docking device 1100 intersects the mitral plane is important for maintaining the integrity of the natural valve biostructure, specifically the leaflets and commissure, to function as a suitable docking site for the final implantation of the THV. In docking devices without such a stretching or ascending region 1140, more of the docking device is located on or in contact with the mitral plane, pinching the natural leaflets, and the relative movement of the docking device relative to the natural leaflets or the docking device rubbing against the natural leaflets may, in some cases, cause damage to the natural leaflets from the atrial side. Having an extension region 1140 allows the portion of the docking device 1100 positioned in the left atrium to rise and separate from the mitral plane.

[0103] Furthermore, the stretched region 1140 of the docking device 1100 may also have a smaller diameter cross-section. In the illustrated embodiment, the wire core of the other region of the docking device 1100 may have a diameter of, for example, 0.825 mm, while the core of the stretched region 1140 may have a diameter of 0.6 mm. In another embodiment, the wire core of the other region of the docking device has a cross-sectional diameter of 0.85 mm, and the stretched region has a cross-sectional diameter of 0.6 mm. When the cross-sectional diameter of the other region of the docking device coil is 0.825 mm or greater, or the cross-sectional diameter is 0.85 mm or greater, the stretched region 1140 has a cross-sectional diameter of 0.4 to 0.8 mm. The thickness can also be selected based on a ratio between them. The stretched region may have a cross-sectional diameter of 50% to 75% of the cross-sectional diameter of the rest of the wire. A stretched region 1140 with a smaller cross-section can have a sharper angle at which the stretched region 1140 rises from the mitral plane. The radius of curvature of the stretched region 1140 and the wire cross-section can further be selected, for example, to ensure sufficient connection points between the central region 1110 and the upper region 1130 of the docking device 1100, and / or to allow the stretched region 1140 to be deployed and retrieved more easily with less force while the docking device is being sent. This is because thinner wire cores are easier to straighten and bend. Furthermore, in embodiments where shape memory such as NiTi is used for the wire core, the thickness of both the stretched region 1140 and the rest of the docking device 1100 must be selected so as not to exceed the strain limit based on the material properties of the selected material.

[0104] As noted above, the wire core of the docking device 100 can be made of NiTi, another shape memory material, or another biocompatible metal or other material, but the wire core can be covered with one or more additional materials. These cover or layer materials can be attached in various ways, including, for example, by adhesion, melting, molding around the core, or by other means including suturing, tying, or bonding the cover / layer to the wire core. Referring briefly to Figure 22, the distal cross-section of the docking device 1100 includes the wire core 1160 and the cover layer 1170. The wire core 1160 can provide strength to the docking device 1100, for example. On the other hand, the base material of the cover layer 1170 covering the wire core 1160 can be, for example, ePTFE or another polymer. The cover layer 1170 is more easily compressible than the wire core 1160, thereby allowing the wire frame and / or supports of the THV to be partially embedded in the cover layer 1170 or otherwise fixed when the THV is expanded within the docking device 1100, providing additional stability. The more easily compressible material also allows for less trauma to the natural valve leaflets and other biostructures being pinched or compressed between the docking device 1100 and the THV, reducing wear and / or damage to the natural biostructures. In the case of ePTFE, the material constitutes a layer that is neither permeable to water nor blood but allows ethylene oxide gas to pass through or penetrate, thereby making it easier to sterilize the wire core 1160 below. On the other hand, the ePTFE cover layer 1170 is not permeable to blood but can be formed with a pore size of, for example, 30 microns to facilitate the adhesion of blood cells to the inner and outer surfaces of the cover layer 1170, for example, to promote internal tissue growth after transplantation. Furthermore, ePTFE is also a very low-friction material. The docking device 1100, having an ePTFE cover layer 1170, provides stability and promotes internal growth.

[0105] While the low-friction ePTFE cover layer 1170 can assist the interaction between the ends of the docking device 1100 and the natural heart biostructure, it may be more desirable to add friction in the central region 1110 that forms the functional coil of the docking device 1100 for docking the THV. Therefore, as can be seen in Figure 19, an additional coating 1180 (which may be the same as or similar to the coating 420 and / or friction element 520) can be added to the central region 1110 of the docking device 1100 in addition to the ePTFE layer 1170. Figure 19A shows a cross-sectional view of each layer. The coating 1180 (shown as a braided layer) or other high-friction layers create additional friction between adjacent coils and against the natural valve leaflets and / or the THV when the THV is expanded within the docking device 1100. The friction generated between the coils and at the interfaces between the inner surface of the central region 1110 of the docking device 1100, the natural mitral valve leaflets, and / or the outer surface of the THV forms a more secure locking mechanism for more firmly securing the THV and the docking device 1100 to the natural valve. The functional coils / winding or central region 1110 of the docking device 1100, i.e., the region of the docking device that interacts with the THV, are generally only the regions where a high-friction coating / layer is desired, and as seen in Figure 19, the braided layer or high-friction coating / layer 1180 does not extend into the lower region 1120 or the stretched region 1140, thereby keeping those regions of the docking device 1100, along with the upper region 1130, low friction and thus promoting less traumatic interactions with the natural valve and other cardiac biostructures. The device can also be modified by any combination of the high-friction coating / layer 1180 and high-friction elements or other special mechanisms described herein and shown in Figures 15-18 to add additional friction elements, and thus improve the holding force between the docking device and the replacement valve.

[0106] Figure 20 is a top view of possible arrangements of the docking device 1100 in the native mitral valve 1810 before expanding the THV within the docking device 1100. In this embodiment, the docking device 1100 is advanced counterclockwise into the left ventricle through the commissure A3P3 1820 of the mitral valve 1810. Once the desired amount of the docking device 1100 (e.g., the majority of the lower region 1120 and the central region 1110) is advanced into the left ventricle, the remaining coils of the docking device 1100, e.g., any remaining portion of the central region 1110 (if any), the stretch region 1140 (or a portion thereof), and the upper region 1130, can then be released from the delivery catheter, for example, by rotating the delivery catheter clockwise or counterclockwise, thereby allowing these portions of the docking device 1100 to be withdrawn or otherwise released, while the positions of the central region 1110 and the lower region 1120 of the docking device 1100 remain fixed or substantially fixed relative to the surrounding biomedical structures. In Figure 20, the parts of the device 1100 below the natural valve are shown by dotted lines.

[0107] It can be extremely important to correctly position the docking device 1100. In one embodiment, the docking device 1100 needs to be positioned relative to the natural valve 1810 such that a desired portion of the docking device 1100 extends through the natural valve 1810 at or near the commissure A3P3 and contacts the atrial side of the natural valve leaflet. For example, as can be seen in Figure 19, the proximal portion of the central region 1110 of the docking device 1100 extends between the proximal end of the sheath or braided layer 1180 and the stretched region 1140, while the ePTFE or low-friction layer 1170 remains exposed. This ePTFE or low-friction region is preferably the portion of the docking device 1100 that intersects the mitral plane and contacts the atrial side of the natural valve leaflet. On the other hand, the portion of the docking device 1100 that passes through the mitral valve may be, for example, a portion of the exposed central region 1110 immediately near the end of the cap or braided layer 1180, or it may include some of the proximal end of the cap or braided layer 1180.

[0108] The advancement of the lower coil or ventricular coil of the docking device 1100 into the left ventricle must be precise. To facilitate this, one or more marker bands or other visualization special mechanisms can be included in any of the docking devices described herein. Figure 21 is a top view of a modified embodiment of the docking device 1100, in which two marker bands 1182 and 1184 are attached to the docking device 1100. The marker bands 1182 and 1184 are arranged side by side. The marker bands and / or visualization special mechanisms can be positioned in various locations, but in Figure 20, the first marker band 1182 is positioned at the proximal end of the high friction layer 1180, while the second marker band 1184 is positioned slightly away from the proximal end of the high friction layer 1180. One marker band 1182 can be made thicker than the other marker band 1184 so that they can be easily distinguished. The marker bands 1182, 1184, or other visualization special mechanisms constitute landmarks for easily locating the proximal end of the high-friction layer 1180 relative to both the delivery catheter and the natural mitral biostructure. Thus, the physician can use the marker bands 1182, 1184, or other visualization special mechanisms to determine when to stop the advancement of the docking device 1100 into the left ventricle (e.g., when the marker band is in the desired position close to commissure A3P3) and when to begin releasing or withdrawing the remaining proximal portion of the docking device 1100 into the left atrium. In one embodiment, the marker bands 1182, 1184 are visualized under fluoroscopy or other 2D imaging techniques, but the present invention is not limited thereto. In some embodiments, instead of the above, one or more marker bands are positioned on the low-friction layer 1170 close to the end of the knitted layer 1180 or on other parts of the docking device 1100, based on user preference. In other embodiments, fewer or more marker bands may be used. The knitted layer 1180 can extend across the portion of the docking device coil that engages with the replacement heart valve.

[0109] Any docking device described herein can be further modified, for example, to facilitate or assist in advancing the docking device to the appropriate position relative to the natural valve. For example, it can also be modified to help prevent damage to the natural valve and other natural cardiac tissues from being caused by the docking device during implantation and placement of the docking device. In mitral applications, when introducing or rotating the lead or distal end of a coil-shaped docking device as described above into a predetermined position within the left ventricle, the distal end can be sized, shaped, and / or otherwise configured to be more easily maneuverable around and rotated around the chordae tendineae. On the other hand, the distal end needs to be non-traumatic so as not to damage the biotissue when advancing the distal end around and / or through the mitral valve biotissue or other valve biotissues.

[0110] On the other hand, in some embodiments, the proximal end of the docking device is attached to a pusher in the delivery catheter that pushes the docking device out of the distal opening of the catheter. The terms pusher, pusher device, and push rod are used interchangeably herein and can be substituted for one another. While attached to the docking device, the pusher can assist in pushing, pulling, or retrieving the docking device relative to the delivery catheter, and can allow for the repositioning of the docking device at any stage throughout the delivery process. The methods described herein may include various steps relating to the retrieval and repositioning of the docking device, for example, the step of retracting or pulling a push rod / suture / tether or other special mechanism to pull / retract the docking device back into the delivery catheter, and then repositioning and reimplanting the docking device to a different position / position or site. In docking devices having a cover layer, such as a fabric layer, that covers the skeleton or coil skeleton of the docking device, frictional forces may be applied to the cover layer, particularly at the proximal and distal ends of the docking device, by adjusting the docking device with a pusher, for example, by the cardiac biostructure and / or the pusher / pushrod, or the pusher device itself. Therefore, both the structure at the ends of the coil of the docking device and the connection technique for connecting the fabric layer to the coil (e.g., adhesion or suturing techniques) may be important in dealing with such frictional forces and preventing the fabric layer from tearing away from the coil or the ends of the coil.

[0111] Considering the above, the docking device 1100 may include a non-traumatic distal end and a proximal end. Figure 22 shows a cross-section of the proximal end of the docking device 1100, illustrating the shapes of the wire core 1160, which can be made of NiTi, for example, and the low-friction cover layer 1170, which can be made of ePTFE or another polymer, for example. The low-friction cover layer 1170 may extend slightly beyond the end of the wire core 1160 and taper to a rounded tip. The rounded extension region constitutes a space for the low-friction cover layer 1170 to adhere to and around the wire core 1160, and for forming a non-traumatic tip. The distal end of the docking device according to this specification (e.g., docking device 1100) may be assembled or configured to have a similar structure.

[0112] Referring to Figures 19 and 22, the docking device 1100 may optionally include additional fixing holes 1164 near the proximal and distal ends, respectively. The fixing holes 1164 can be used to further secure the cover layer 1170 to the wire core 1160, for example, by sutures or other tie-downs. This and / or similar fastening means can further prevent slippage or movement between the core 1160 and the cover layer 1170 during deployment and / or retrieval of the docking device 1100. In some cases, the cover layer 1170 may be attached, melted, molded, etc., around the core without sutures.

[0113] In some embodiments, the distal tip of the docking device 1100 can be tapered radially inward, for example, in the tangential direction of the circle formed by the coil of the central region 1110. Similarly, the stabilizing coil / winding or upper region 1130 of the docking device 1100 can be tapered radially inward, for example, in the tangential direction of the circle formed by the coil of the central region 1110 (or so as to have a tangential portion), and can also be oriented, for example, slightly upward toward the atrial ceiling away from the other coils of the docking device 1100. The upper region 1130 of the docking device 1100 can be configured as described above as a precaution if, for example, the docking device 1100 is not positioned in the desired position described above and slides toward the left ventricle, and the upper region 1130 may come into contact with the mitral plane, or if the docking device 1100 is implanted in a heart with abnormal biostructure.

[0114] With regard to facilitating the attachment of the docking device 1100 to a pusher / pusher rod or other advancement or retrieval mechanism in a delivery catheter, the proximal end of the docking device 1100 may further include a second hole or bore 1162. As shown in Figure 22A, the hole or bore 1162 may be looped to allow a retaining device, such as a long release / retrieval line or suture 1163, to connect or attach the docking device 1100 to the distal end of the pusher or other special mechanism of the delivery catheter. The hole 1162 may be rounded and smoothed to prevent unintended breakage of the line / suture. The line / suture may also allow the docking device 1100 to be more securely attached to the delivery catheter and to be pulled and retrieved when retraction, partial retrieval, or complete retrieval of the docking device 1100 is desired. Figure 22C shows a detailed view of a release wire / suture 1163 looped through the bore 1162 of the docking device 1100, where the outside of the delivery catheter 1010 is detached. The pusher device 1165 is configured as a pusher tube with a lumen within it, for example, extending from end to end. In this embodiment, the wire / suture extends through a vertical hole that penetrates the pusher device / tube 1165 held within the delivery catheter 1010. On the other hand, after the desired position of the docking device 1100 is achieved, a physician or other user can simply cut the proximal end of the wire / suture and pull the wire / suture proximal to pass the cut end of the wire / suture through the hole 1162, thereby releasing the docking device 1100 from the delivery catheter. In one embodiment, the wire / suture can be extended in a loop so as to extend from the bore 1162 through the pusher device / tube 1165 to a handle or hub outside the patient (the loop can be opened and closed by securing its two ends to the handle or hub).During cutting, a portion of the wire / suture can be left attached to the handle or hub (or, in some cases, held by a medical professional), thereby allowing the wire / suture to be pulled proximal until the cut end emerges from the bore 1162 and releases the delivery device. Figure 22B shows another embodiment in which the wire / suture 1163 is looped through the bore 1162 at the proximal end of the coil.

[0115] Various other modifications can be made to either the distal end or the proximal end, or both, of any of the docking devices described herein, thereby making the docking device more robust. Figure 23 shows exemplary ends of a core skeleton or coil skeleton of a docking device according to another embodiment of the present invention, which can be used for the distal end and / or proximal end of the device. The ends of the coil / core 710 may be made of or contain nitinol, another shape memory metal or material, and / or a non-shape memory material. The illustrated ends of the coil / core 710 have a substantially flat or rectangular cross-section and include a tip 712 (e.g., a ring-shaped tip or a tip of other shape). The illustrated rectangular cross-section may form so only for the ends of the coil 710 or extend over the length of the coil 710, whereas in other embodiments, the entire coil 710, including the distal end region and / or proximal end region, may have a more rounded cross-section or a cross-section of other shape. The ring-shaped tip 712 has an enlarged or expanded width compared to the rest of the coil / core 710 and defines a through-hole 714 to facilitate the passage of one or more wires / sutures. The free end 716 of the ring-shaped tip 712 can be configured as a circle or other arc, while the opposite end 718 of the tip 712 can be formed as a rounded or tapered transition between the tip 712 and the adjacent region of the coil 710. The coil 710 may include one or more cover fastening holes 720 near the tip 712 to further assist in fastening a cover layer placed on or attached to the coil 710.

[0116] The cover layer covering the skeleton / core 710 of the docking device can be, for example, one or more of the aforementioned coatings or layers (e.g., low-friction and / or high-friction coatings). The cover layer can be made of or include an ePTFE core tube covered with woven PET cloth, or it can be made of or include any other cloth or other biocompatible material. Such a cover layer can be used to cover a large portion of the docking device, for example, from the body of the coil skeleton / core 710 to the end 718 of the tip 712, or slightly above the end 718. In this case, the cover layer can be connected to the ring-shaped tip 712 via sutures that pass through holes 714, go over the arcuate free end region 716, and cover the arcuate free end region 716. The sutures serve to secure the cover layer to the skeleton / core 710 and also to soften the edges of the ring-shaped tip 712. Additional sutures can be passed through one or more cover fastening holes 720 near the tip 712 to further fasten the cover layer to the skeleton / core 710.

[0117] Figure 24 shows the ends of the skeleton or core of a docking device that can be used at the proximal and / or distal ends of any of the docking devices described herein. The ends of the coil / core 810 may be made of or contain nitinol, another shape memory metal or material, and / or a non-shape memory material. The ends of the coil / core 810 have a distal ball-shaped tip 812. The ball-shaped tip 812 may be preformed together with the rest of the skeleton / core 810, or may be a separate ball-shaped or short club-shaped appendage with a rounded end that is welded to or otherwise attached to the end of the coil / core 810. Meanwhile, a small gap 814 is formed or left between the ball-shaped tip 812 and the rest of the coil / core 810. The gap 814 may be about 0.6 mm, or any other size sufficient to facilitate the passage and / or crossing of one or more sutures for fastening or otherwise connecting a cover layer to the end of the coil / core 810.

[0118] One or more cover layers or coatings covering the coil skeleton / core 810 of the docking device may be similar to the cover layers or coatings described above. The cover layers / coatings may be made of, for example, an ePTFE core tube covered with woven PET cloth or include such an ePTFE core tube, or may be made of, or include any other cloth or other biocompatible material. In one mounting method, such a cover layer / coating covers the body of the coil skeleton 810, covers the gap 814, and covers up to or slightly over the ball-shaped tip 812, while exposing the free end of the ball-shaped tip 812. The cover layer / coating is then connected to the end of the coil 810, for example, via sutures passing through the gap 814. In a second mounting method, the entire ball-shaped tip 812 is wrapped and completely covered with the cover layer, and then sutures are passed through and / or crossed with the gap 814 to secure the entire cover layer over the end of the ball-shaped tip 812.

[0119] The tips 712, 812, as illustrated and described with respect to Figures 23 and 24, each docking device has a rounded end with a small nose which helps to allow each docking device to be manipulated more easily and conveniently within the left ventricle. Furthermore, since each of the tips 712, 812 is curved or rounded, the tips 712, 812 form ends with soft edges. The shape and structure of the ends of each coil skeleton 710, 810, the type, structure and configuration of the cover layer, and the suturing technique for attaching the cover layer to the skeleton 710, 810 also allow for a tight connection between the tips 712, 812 and their respective cover layers without the use of glue or other adhesives. Furthermore, this tip configuration prevents the exposure of sharp edges and prevents the surface of the skeleton 710, 810 from cutting and / or protruding from the cover layer as a result of any frictional forces applied to the cover layer of the docking device during or after the docking device has been delivered.

[0120] As described above, in some embodiments, the docking device can be attached to a pusher which can facilitate pushing or pulling the docking device to feed and readjust it. Figure 25 shows an exemplary end of a coil skeleton / core 910 of a docking device 900 which can be used at the distal end and / or proximal end (which may be the same as or similar to other docking devices described herein), and Figure 26 shows the end of the docking device 900 which includes a cover layer 920 on the coil skeleton / core 910 and sutures 930 for attaching the cover layer 920 to the coil skeleton / core 910.

[0121] Referring first to Figure 25, similar to the cross-section of the distal end of the coil / core 710 described above, the coil skeleton / core 910 of the docking device 900 has an end region having a substantially flat or rectangular cross-section. The rectangular cross-section shown may form so only for the end region of the coil / core 910 or extend over the length of the coil / core 910, whereas in other embodiments, the entire coil / core 910, including the end region, may have a more rounded or other shaped cross-section. An oval or elongated slit hole 912 extends through the end region of the coil / core 910, with two sides 914, 916 of the coil / core 910 extending along each side of the slit hole 912 to connect the proximal free end 918 of the coil / core 910 to the rest of the coil / core 910. The slit hole 912 is wide enough for a needle and / or one or more sutures 930 to pass through or cross.

[0122] As shown in Figure 26, the coating / cover layer 920 can be, for example, a coating, a fabric layer, or another layer having the same or similar configuration as described above with respect to previous embodiments of the docking device. The coating / cover layer 920 wraps around the coil / core 910 and is secured to the coil / core 910 by sutures 930 that extend along and pass through the slit hole 912, or otherwise fixed to the coil / core 910. The sutures 930 can intersect the slit hole 912 in a "8" shape as shown in Figure 26, so that the sutures 930 pass through the slit hole 912 at least twice and wrap around the opposing sides 914, 916 of the coil / core 910 adjacent to the slit hole 912 at least once each. In the illustrated embodiment, the sutures 930 pass through the slit hole 912 at least four times and wrap around the sides 914, 916 on each side of the slit hole 912 at least twice each. The suture 930 is positioned or moved proximal to the slit hole 912, near the free end 918 of the coil skeleton / core 910, so that the distal end of the slit hole 912 remains exposed and accessible to the user, and is open wide enough for the pull wire 940 (e.g., release / retrieval suture) of the delivery catheter pusher to pass through or cross over it, thereby establishing a secure connection between the docking device 900 and the pusher. The pull wire 940 can be a suture.

[0123] When the docking device 900 is connected to the pusher via the pull wire 940, the distal end of the pusher (not shown) abuts against the proximal free end of the docking device 900, or the pull wire 940 abuts against the end of the slit hole 912, thereby advancing the docking device 900 from the delivery catheter. On the other hand, when it is desirable to pull back or retract the docking device 900 to readjust its position at the implantation site, for example, the pull wire 940 can be pulled proximal to retract the docking device 900 as well. Similar steps can be used for other docking devices according to this specification. When the pull wire 940 is pulled back, the pull wire abuts against the suture 930 extending through the slit hole 912, which, by a "figure eight" suture, forms a cross suture region that constitutes a buffer loading region into which the pull wire 940 can abut. Therefore, the suture thread 930 serves to fix and attach the cover layer 920 to the coil skeleton / core 910, and also to conceal or cover the sharp edges of the slit hole 912, preventing the pull wire 940 from being damaged or broken by the docking device 900 while retrieving the docking device 900 or pulling it for other purposes, and conversely, preventing the docking device 900 from being damaged by the pull wire 940.

[0124] Similar to the end configurations described with respect to Figures 23 and 24, each of the shape and structure of the end of the coil skeleton / core 910, the type, structure, and configuration of the coating / cover layer 920, and the connection technique (e.g., suture technique) for attaching the coating / cover layer 920 to the coil skeleton / core 910 contributes to a tight connection between the end of the coil 910 and the coating / cover layer 920, which can be achieved with or without the use of glue or other adhesives (e.g., the suture technique does not require these). Furthermore, this end structure and configuration prevents the exposure of sharp edges and prevents the surface of the coil skeleton / core 910 from cutting through and / or protruding from the coating / cover layer 920 as a result of any frictional forces applied to the coating / cover layer 920 of the docking device 900 during or after the docking device is being fed.

[0125] In various other embodiments, one or all of the special mechanisms different from those in the various embodiments described above can be combined or modified based on the requirements of each individual patient. For example, different special mechanisms related to various different problems (e.g., flexibility, increased friction, protection) can be incorporated into the docking device as needed for each individual application, based on the specific characteristics or requirements of a particular patient.

[0126] Embodiments of docking devices described herein have been conceptually outlined above in relation to assisting in the fixation of a replacement valve at the mitral position. However, as stated above, the docking devices or slightly modified embodiments thereof can also be similarly applied to valve replacement at other valve sites, such as the tricuspid valve, pulmonary artery, or aortic positions. In patients diagnosed with dysfunction at any of these locations, the valve loop may become enlarged, preventing the natural valve from properly joining, or the valve loop may become excessively large, excessively soft, or other diseases may become so pronounced that it is unable to firmly hold an expandable valve. Therefore, using a rigid or semi-rigid docking device is also advantageous in fixing the replacement valve to those valve sites, for example, to prevent the replacement valve from shifting during normal cardiac function.

[0127] The docking devices described herein may be further covered with one or more coatings or cover layers, as described above. Furthermore, the cover layers for any of these applications may be made of or contain materials that promote more rapid internal growth of the tissue. The cover layers may be further configured to have a larger surface area, for example, by a velour film, a porous surface, a knitted surface, etc., to further enhance internal growth of the tissue.

[0128] Docking devices similar to those described above can also create a more secure loading zone in valves other than the mitral valve when applied to those sites. The docking device and associated replacement valve can be applied in the same way as described for implantation in the mitral valve. Possible access points for tricuspid valve replacement can be, for example, transseptal access, while possible access points for aortic replacement can be transfemoral access. However, access to each valve site is not limited to these. When the coiled docking device described above is used in other valve sites, for example, the valve leaflets and other tissues are sandwiched between the coils of the docking device and held in place by the spring force of the docking device, thereby allowing the natural valve leaflets to be circumferentially tightened or retained after the replacement valve is deployed at the natural valve loop. Furthermore, sliding or other movement of the docking device and the sandwiched tissue relative to the docking device is further inhibited, preventing unwanted growth or expansion of the natural valve loop over time.

[0129] Due to several possible attachment configurations between the anchor / docking device and the release or retrieval line / suture, and the movement and / or sliding of each component, the anchor / docking device may, in some cases, become T-shaped or "T-formed" relative to the pusher tube and / or delivery catheter, for example, so that the axis of the pusher tube and / or delivery catheter is no longer aligned with the axis of the proximal end of the anchor / docking device (may become perpendicular). For example, when the retrieval line / suture is pulled, the end 2700 of the docking device and the pusher device / tube 1165 and / or delivery catheter may be in an orthogonal relative position or substantially orthogonal relative position rather than an aligned position, for example, in a position that forms a relative "T". When this happens, it may be difficult to retrieve or pull the anchor / docking device into the delivery catheter.

[0130] Any anchor / docking device described herein can, advantageously, be configured and designed to suppress, prevent, or resist T-shaping or "T-forming." For example, any anchor / docking device described herein can be configured to have a curved proximal end that can more easily guide into the pull-delivery catheter without getting caught on the edge of the catheter and / or shifting away from or perpendicular to the pusher tube and catheter. Additionally or alternatively, any anchor / docking device described herein can be configured to deflect (or deflect in a direction that aligns) the line of force F applied by the retrieval suture / wire 1163 to align with or substantially align with the moment of inertia A with respect to the central axis or region of the end 2700 of the docking device (see Figure 27). This alignment can help suppress and / or prevent the end 2700 of the docking device from sliding or moving relative to one side of the pusher device or tube 1165 when the retrieved suture pulls the end 2700 of the docking device against the pusher device and / or when the docking device is drawn into the delivery catheter. This can help suppress and / or prevent a T-shape effect or "T-forming" effect between the end 2700 of the docking device and the pusher tube 1165 and / or the delivery catheter. Embodiments / designs described below, which include one or more special mechanisms to suppress and / or prevent the end 2700 of the docking device from becoming T-shaped and shifting relative to the pusher device or tube 1165 and / or sliding to one side of the pusher device or tube 1165, will be described primarily with reference to the docking device 1100, but it will be understood that all docking device embodiments disclosed herein may have one, some or all of these special mechanisms.

[0131] When tension is applied to the release / retrieval suture 1163, such as when attempting to retrieve the docking device 1100, the docking device 1100 generally follows the line of tension as it moves toward the pusher tube 1165 and / or delivery catheter. In some configurations, the end 2700 may move or slide toward the aforementioned "T" position. For example, in some potential configurations, if the suture release hole 1162 is oriented radially outward on the docking device 1100, the line of tension F from the release suture 1165 to the end 2700 may not align with the moment of inertia A of the end 2700 of the anchor / docking device with respect to the axis or region. If the angle between the tension line F and the axis A at the end of the docking device 1100 is too large, attempting to retrieve the docking device 1100 may cause the end 2700 of the docking device 1100 to slip beyond the distal tip of the pusher tube 1165, deviating from the aligned contact position and moving the docking device 1100 into a "T" position relative to the pusher tube 1165, thereby making retrieval into the delivery catheter 1010 more difficult.

[0132] Referring to Figures 27A to 30B, exemplary embodiments of the docking device 1100 include a proximal connecting end or tip to maintain a match or substantial match between the line of force F applied by the retrieved suture / wire 1163 and the moment of inertia A with respect to the central axis or region of the end 2700 of the docking device. In the example shown by Figures 27A to 27F, the docking device 1100 may include a connecting end / tip or spherical end / tip 1200 that is integrated with or can be molded or machined onto the end of the coil / core 1160 of the docking device 1100, or a cap attached to the proximal end of the coil / core 1160 by suture, welding, adhesive, or other method known in the art.

[0133] The spherical end or tip (for example, a ball-shaped end or tip) can take on a variety of different forms. In the example shown in Figures 27D to 27F, the spherical tip / end 1200 has a spherical portion 1202, a transition portion 1204, and a neck portion 1206. The spherical portion 1202 is located at the proximal end of the spherical proximal tip / end 1200. The neck portion 1206 is located distal to the spherical portion 1202 and connects to the coil / core 1110 of the docking device 900. The transition portion 1204 connects the spherical portion 1202 to the neck portion 1206. The spherical portion 1202 has a substantially spherical or ball shape, and the neck portion 1206 can have a shape and size that is a continuation of the coil / core 1160 of the docking device 1100, or that fits as a cap onto the proximal end of the coil / core 1160. The transition portion 1204 forms a gradual and smooth transition between the larger diameter of the spherical portion 1202 and the smaller diameter of the neck portion 1206. However, the spherical proximal tip 1200 can have a variety of different shapes and sizes.

[0134] The spherical proximal tip / end 1200 includes a central passage 1210 extending along the tip axis AT, aligned with the moment of inertia A with respect to the axis or region, from the center / end of the spherical portion 1202 (Figure 27A). The central passage extends through the spherical proximal tip 1200 to the center of the spherical portion 1202. In the illustrated example, two oblique lateral passages 1212 extend to the central passage 1210. The illustrated passages 1212 begin at a position on the outer surface of the spherical portion 1202 distal to the center of the spherical portion 1202. The lateral passages 1212 define a pair of openings outside the spherical proximal tip 1200. In the illustrated example, the lateral passage openings are located substantially at the point where the spherical portion 1202 and the transition portion 1204 converge. However, the lateral passage openings can be located at a variety of different positions. In the illustrated embodiment, the side passages 1212 merge and open at the central passage 1210 substantially at the center of the spherical portion 1202. The central passage 1210 and the side passages 1212 can define a smooth bifurcated passage. In one exemplary embodiment, the edges of the openings of passages 1210, 1212 and / or the intersection of passages 1212 and 1210 can be smoothed or rounded. The central passage deflects the suture passing through it so as to align (in the direction of alignment) with the central axis or longitudinal axis of the tip 1200 and the end of the docking device. The tip / end 1200 may include a covering.

[0135] Although the spherical tip 1200 has been described as having a central passage 1210 and two side passages 1212, it should be understood that other designs are possible. For example, the tip 1200 may include a central opening at its proximal end, from which two oblique passages can extend directly. The two oblique passages may open to the central opening and extend distally and radially outward from the central opening.

[0136] Referring to Figure 27C, when in use, one end of the retrieved or released suture / wire 1163 is passed through one of the central passage 1210 and the lateral passage 1212, positioned around the outer surface of the tip 1200, and passed through the other lateral passage 1212, exiting through the central passage 1210. Both ends of the suture / wire 1163, once passed through in this manner, extend from the proximal end of the central part of the spherical connecting tip 1200, thereby aligning the line of tension or force F applied to the tip 1200 by the suture / wire 1163 with the longitudinal axis A of the tip 2700 and the axis AT of the central passage of the tip 1200.

[0137] In one exemplary embodiment, the spherical shape of the spherical portion 1202 allows the distal end of the pusher tube 1165 and / or the delivery catheter 1010 to rotate or swirl relative to the proximal portion of the docking device 1100 without the tip 1200 shifting away from the end of the pusher tube and / or becoming T-shaped relative to the catheter 1010. Alignment of the line of tension F with axis A, AT and / or the spherical proximal end of the tip 1200 prevents the docking device 1100 and the pusher tube 1165 and / or the delivery catheter 1010 from shifting relative to each other and becoming T-shaped.

[0138] Referring to Figure 27E, the spherical proximal tip / end 1200 may optionally include a bore 1230 at the distal end of the tip 1200 to accommodate the proximal end of the coil / core 1160 of the docking device 1100. The bore 1230 terminates at a bore base 1232. The bore base 1232 can abut against the proximal end of the inserted coil / core 1160. The bore base 1232 may have a cylindrical, conical, or other shape. Furthermore, the spherical proximal tip 1200 may optionally include an eyelet 1240 or slot extending through the tip / end 1200 in the neck portion 1206. A suture can be passed through the eyelet 1240 and through the hole 1162 (see Figure 22) in the coil / core 1160 to connect the spherical tip 1200 to the coil / core 1160. Any coating / cover layer can be provided on a portion of the tip 1200, such as the coil / core and / or neck portion 1206. Any coating layer can also be attached using eyelets or slots 1240 and holes 1162.

[0139] The spherical connector tip / end 1200 can be integrated with the docking device 1100, machined onto the proximal end of the docking device 1100, or serve as a cap attached to the proximal end of the docking device by sutures, welding, or other means of attachment. The positions of the central passage 1210 and the side passages 1212 allow for the use of thicker walls, thereby making the spherical tip / end 1200 more robust.

[0140] The spherical tip 1200 can be configured and designed so that its distal portion has a larger diameter than the end 2700 of the docking device 1100 (Figure 27A), or so that its distal portion forms a coplanar plane with the end 2700 (Figure 27G). The tip / end 1200 can be integrated with the docking device without requiring a bore 1230 or bore base 1232, or the diameter of the proximal end of the end 2700 can be reduced by machining or other means so that it can be accommodated in the bore 1230 of the spherical proximal tip 1200 when the distal portion of the tip 1200 forms a coplanar plane with the end 2700 of the docking device. Other methods can also be considered for mounting the spherical proximal tip 1200 so as to form a coplanar plane with the end 2700 of the docking device 1100.

[0141] Spherical connector tips / ends can be made in a variety of different ways. In one exemplary embodiment, the spherical tip / end 1200 can be made by zapping (e.g., electrical discharge machining) the proximal end of the tip / end 1200 to form a sphere. The central passage 1210 and the side passages 1212 can be formed by laser processing or micromachining. Radii can be formed on the edges using electroplating. In one exemplary embodiment, the spherical tip / end 1200 can be made of nitinol. The tip / end 1200 can be made of other materials such as PEEK (polyether ether ketone), Ultem or other polyetherimides, stainless steel, shape memory metals or materials other than nitinol, and / or other non-shape memory materials or any other materials known in the art. In one exemplary embodiment, the spherical tip / end can be configured to withstand a force of 130 Newtons F applied by a suture without bending or breaking.

[0142] In an exemplary embodiment, the spherical portion 1202 may have a small diameter, such as between 2.0 mm and 2.50 mm, for example between approximately 2.10 mm and 2.30 mm, for example, a diameter of 2.20 mm. In an exemplary embodiment, the neck portion 1206 may have a small outer diameter, such as between 1.10 mm and 1.50 mm, for example between approximately 1.20 mm and 1.40 mm, for example, an outer diameter of approximately 1.3 mm. In an exemplary embodiment, the transition portion 1204 may have a small radius, such as between 0.8 mm and 1.20 mm, for example between approximately 0.90 mm and 1.10 mm, for example, a radius of approximately 1.0 mm. The central passage 1210 may have a variety of different shapes. For example, the central passage 1210 may have a circular opening, an oval opening, a conical opening, a rectangular opening, and the like. In the illustrated example, the central passage 1210 has an oval opening to the proximal end of the tip 1200. The oval opening can be small in size, such as having a width between 0.95 mm and 1.30 mm, for example between about 1.03 mm and 1.23 mm, for example, about 1.13 mm, and a height between 0.50 mm and 0.85 mm, for example between about 0.55 mm and 0.77 mm, for example, about 0.65 mm. The side passages can have a variety of different shapes. In the illustrated embodiment, the side passage 1212 has a round opening with a diameter between 0.50 mm and 0.85 mm, for example between about 0.55 mm and 0.75 mm, for example, a diameter of 0.65 mm. The axes extending through each side passage 1212 can be positioned at an angle between 115° and 135° from the vertical axis extending through the central passage 1210, for example, an angle between approximately 120° and 130°, for example, an angle of approximately 126°.

[0143] Furthermore, the edge between the bore 1230 and the bore base 1232 can be rounded. The rounded edge can have a radius between approximately 0.1 mm and 0.4 mm, such as approximately 0.20 mm. The bore 1230 can extend proximal from the distal end to the tip 1200 by 1.9 mm to 2.35 mm, for example between approximately 2.01 mm and 2.21 mm, for example, only by approximately 2.11 mm.

[0144] Furthermore, in the illustrated embodiment, the eyelet 1240 is shaped to have two semicircles on either side of the rectangular portion. The length of the rectangular portion of the eyelet 1240 can be between 0.40 mm and 0.47 mm, for example, between approximately 0.46 mm and 0.66 mm, for example, about 0.56 mm. The radius of the semicircular portion of the eyelet 1240 can be between 0.125 mm and 0.25 mm, for example, between approximately 0.15 mm and 0.20 mm, for example, about 0.17 mm. The distance from the distal end of the rectangular portion of the eyelet 1240 to the distal end of the spherical proximal tip 1200 can be between 0.7 mm and 1.1 mm, for example, between approximately 0.8 mm and 1.0 mm, for example, about 0.9 mm, etc.

[0145] As shown in Figures 28A to 28F, in exemplary embodiments, the spherical connecting tip / end 1200 may be similar to the spherical proximal tip / end in Figures 27A to 27F (and including any of the special mechanisms, dimensions, etc. described above), but may have a concave collar, annular recess, or channel 1220 that can be configured to hold a portion of the release suture 1163. As previously stated, the spherical tip 1200 may have a spherical portion 1202, a transition portion 1204, a neck portion 1206, a central passage 1210, and two lateral passages 1212. In the example shown in Figures 28A to 28E, instead of the transition portion 1204 whose thickness gradually decreases between the spherical portion 1202 and the neck portion 1204, the transition portion 1204 may include the illustrated annular recess or channel 1220 having a smaller diameter than the spherical portion 1202 and the neck portion 1206. The annular recess 1220 may have a partial toroidal shape and may extend along the circumference of the spherical tip 1200. The distal end of the lateral passage 1212 opens at least partially into the annular recess 1220, and the surface of the annular recess 1220 and the edges of the lateral passage 1212 that open into the annular recess may be smooth or, in some cases, rounded.

[0146] Referring to Figure 28C, one end of the release suture 1163 is passed through one of the central passage 1210 and one of the lateral passages 1212, around a portion of the annular recess 1220, through the other lateral passage 1212, and out of the central passage 1210. Both ends of the release suture 1163, once passed through in this manner, extend from the proximal and central portions of the tip 1200, thereby aligning the line of tension or force F applied to the tip 1200 by the release suture 1163 with the longitudinal axis A of the end 2700 and the axis AT of the central passage of the tip 1200. When the docking device 1100 is pushed, retrieved, or otherwise repositioned, a portion of the release suture 1163 may remain in the annular recess 1220. Although the pusher tube 1165 and catheter 1010 are shown to be relatively short compared to the spherical proximal tip 1200, the pusher tube 1165 and catheter 1010 can be extended to any desired length. The sphericity of the spherical portion 1202 allows the distal end of the pusher tube 1165 to rotate or swirl relative to the proximal portion of the docking device 1100 without the tip 1200 shifting away from the end of the pusher tube. Alignment of the line of tension F with axis A, AT and / or the spherical proximal end of tip 1200 prevents the docking device 1100 and the pusher tube 1165 from shifting relative to each other and forming a T-shape.

[0147] The spherical connecting tip may be integrated with the delivery device and / or its core, or it may include a bore 1230 and a bore base 1232 at the distal end of the tip 1200 to accommodate the proximal end of the coil / core 1160 of the docking device 1100. In the illustrated embodiment of Figure 28D, the bore base 1232 is conical, but it may be cylindrical or of another shape. Any coating / cover layer may be provided on part of the tip 1200, such as the coil / core and / or neck portion 1206. As described above, the spherical proximal tip 1200 may be integrated with the delivery device and / or core, machined onto the proximal end of the docking device 1100, or may be a cap attached to the proximal end of the docking device by sutures, welding, adhesive, or other attachment means. As described above, the spherical proximal tip 1200 can be designed such that its distal portion has a larger diameter than the end portion 2700 of the docking device 1100 (Figure 28A), or that its distal portion forms the same plane as the end portion 2700 (Figure 28F).

[0148] In the exemplary embodiments shown in Figures 28A to 28E, the spherical proximal tip 1200 can have a length between approximately 4.4 mm and 4.8 mm, for example, approximately 4.6 mm. The spherical portion 1202 can have a length between 0.9 mm and 1.3 mm, for example, between approximately 1.0 mm and 1.2 mm, for example, approximately 1.1 mm, and a diameter between 2.0 mm and 2.4 mm, for example, between 2.10 mm and 2.30 mm, for example, approximately 2.20 mm. The neck portion 1206 can have a length between 1.8 mm and 2.2 mm, for example, between approximately 1.9 mm and 2.1 mm, for example, approximately 2.00 mm, and an outer diameter between 1.65 mm and 2.05 mm, for example, between approximately 1.75 mm and 1.95 mm, for example, approximately 1.85 mm. The transition portion 1204 can have an overall length of approximately 1.5 mm. The transition section 1204 can curve and become smaller in diameter when it merges with the spherical section 1202 and the neck section 1206. The annular recess 1220 can take on a variety of different forms. The annular recess 1220 can have a single diameter (when viewed in cross-section) or it can have two or more different diameters. In one exemplary embodiment, the diameter of the annular recess is between 0.5 mm and 1.5 mm, for example between 0.6 mm and 1.2 mm, for example between 0.7 mm and 1.1 mm, for example between 0.8 mm and 1.0 mm. However, the transition section 1204 and the annular recess 1220 can have any size and shape.

[0149] In Figures 28A to 28E, the opening of the central passage 1210 is stadium-shaped, and its length can be between 0.95 mm and 1.30 mm, for example between approximately 1.03 mm and 1.23 mm, for example between approximately 1.13 mm, and its height can be between 0.40 mm and 0.80 mm, for example between approximately 0.50 mm and 0.70 mm, for example between approximately 0.60 mm. The angle formed between the vertical axis of the central passage 1210 and the vertical axis of the side passage 1212 may be between 130° and 160°, for example between approximately 140° and 150°, for example between approximately 146°. The diameter of the side passage 1212 can be between 0.40 mm and 0.80 mm, for example between approximately 0.50 mm and 0.70 mm, for example between approximately 0.60 mm.

[0150] Furthermore, the bore 1230 can be circular, with a diameter between 0.7 mm and 1.05 mm, for example between 0.77 mm and 0.97 mm, for example, about 0.87 mm, and extending proximal from the distal end to the tip 1200 for a length between 1.9 mm and 2.35 mm, for example between about 2.01 mm and 2.21 mm, for example, about 2.11 mm. The eyelet 1240 can be shaped to have two semicircles on either side of a rectangular portion. The rectangular portion of the eyelet 1240 can have a length between 0.40 mm and 0.47 mm, for example between about 0.46 mm and 0.66 mm, for example, about 0.56 mm. The semicircular portions of the eyelet 1240 can have a radius between 0.125 mm and 0.25 mm, for example between about 0.15 mm and 0.20 mm, for example, about 0.17 mm. The distance from the distal end of the rectangular portion of the eyelet 1240 to the distal end of the spherical proximal tip 1200 is between 0.7 mm and 1.1 mm, for example, between approximately 0.8 mm and 1.0 mm, for example, approximately 0.9 mm.

[0151] Figures 29A to 29E show exemplary embodiments of the docking device 1100. In the examples shown by Figures 29A to 29E, the docking device 1100 includes a loop-shaped proximal tip or end 1300 (for example, including a loop at the proximal tip / end). The loop-shaped proximal tip 1300 can be formed by machining or a similar process. The loop-shaped proximal tip 1300 can be formed in a variety of different ways. Referring to Figure 29C, in the exemplary embodiment, the proximal end of the coil / core 1160 is bent or folded and attached to the distal point of the coil / core 1160 to define the inner loop surface 1310, the outer loop surface 1312, and the suture receiving area H. The release suture 1163 is then looped through the suture receiving area H, and the docking device 1100 is retrieved using the release suture 1163 as described above. When the docking device 1100 is pushed using the pusher tube 1165, the distal end of the pusher tube 1165 may contact the outer loop surface 1312 and may rotate or swirl along the outer loop surface 1312. The loop portion of the release suture 1163 can rotate along the inner loop surface 1310, thereby causing the line of tension F applied by the release suture 1163 to substantially align with or be aligned with the moment of inertia A with respect to the axis or region of the end of the docking device. The alignment of the line of tension F with the axis A of the end 2700 and / or the ability of the outer loop surface 1312 to rotate relative to the pusher tube 1165 and / or the delivery catheter 1010 prevents the docking device 1100 and the pusher tube 1165 and / or the catheter 1010 from shifting relative to each other. Although the pusher tube 1165 and catheter 1010 are shown as relatively short in Figure 29B compared to the loop-shaped proximal tip 1300, the pusher tube 1165 and catheter 1010 can be extended to any desired length.

[0152] Referring to Figures 29C and 29D, in exemplary embodiments, the loop-shaped proximal tip 1400 can be made by cutting or grinding the proximal portion of the coil / core 1160, bending or folding the proximal tip of the docking device 1100, and connecting the proximal tip of the docking device 1100 to the distal point of the docking device 1100. As shown in Figures 29C to 29E, the proximal portion of the tip 1400 is ground to define a flat longitudinal surface 1302 along the length of the coil / core 1160 to the distal point 1304. In further exemplary embodiments, a notch is made in the coil / core 1160 by wire grinding or laser cutting. The edges of the flat longitudinal surface 1302 can be rounded. In the illustrated embodiment, the flat longitudinal surface 1302 is rounded or tapered near the distal point 1304. Next, the flat longitudinal surface 1302 is folded toward the distal point 1304 to define the inner loop surface 1310 and connected to the rest of the coil / core 1160 at connection point 1306 near the distal point 1304. In an exemplary embodiment, the proximal end of the flat longitudinal surface 1302 is welded at connection point 1306. However, other methods of connecting the flat longitudinal surface 1302 to connection point 1306 are possible, such as heat treatment or the use of adhesive, or the surface 1302 may abut point 1306 without direct connection.

[0153] The loop-shaped proximal tip 1300 is designed and constructed to slide smoothly through the delivery catheter. The transverse edges of the flat longitudinal surface 1302 can be rounded. The outer loop surface 1312 can be rounded to create a smooth transition to the rest of the coil / core 1160. In an exemplary embodiment, the loop-shaped proximal tip 1300 is made of nitinol and can withstand a force of 130 Newtons without bending or breaking, without breaking the weld, or without collapsing the loop. However, the tip 1300 can be made from other materials such as PEEK, Ultem, stainless steel, shape memory metals or materials other than nitinol, and / or other non-shape memory materials.

[0154] Regarding the attachment of the cover, as shown in Figure 29E, the loop-shaped proximal tip 1300 may include a bore 1340 that extends through the coil / core 1160 at a point distal to the connection point 1306. A suture or other attachment device extends through the bore 1340 to connect the coil / core 1160 to the cover. The bore 1340 may have a size that allows a suture or other attachment device to be fitted into the bore 1340 and allows the bore 1340 to be rounded and smoothed. The coating may extend, for example, to a point between the bore 1340 and the connection point 1306.

[0155] In the exemplary embodiments shown in Figures 29A to 29E, the coil / core 1160 can have a variety of different shapes and sizes. For example, the coil / core 1160 can have a thickness or diameter between 0.75 mm and 0.95 mm, for example, about 0.85 mm. The proximal portion of the coil / core 1160 at the flat longitudinal surface 1302 can have a thickness of at least 0.4 mm, for example, about 0.5 mm. The height of the outer loop surface 1312 can be less than 2.0 mm, for example, about 1.9 mm. The height of the inner loop surface 1310 can be at least 0.4 mm, for example, about 0.5 mm. The length of the inner loop surface can be at least 1 mm, for example, 1.20 mm. The bore 1340 can be 3.0 mm or less from the proximal point of the outer loop surface, for example, about 2.8 mm.

[0156] Figures 30A and 30B show exemplary embodiments of a docking device 900 or the core of a docking device, configured to align the line of force F applied by the retrieval suture 1163 with the center of mass A with respect to the central axis or region of the end 2700 of the docking device. In the illustrated example, the proximal end of the docking device 900 may include a concave channel or groove 950. The illustrated proximal end of the docking device 900 is similar to the proximal end shown in Figures 25 and 26 and will be described as having similar special mechanisms and reference numerals. However, it will be understood that the groove 950 may be included in the proximal end of other designs having different shapes or configurations, as will be discussed later.

[0157] The groove 950 can be provided at the proximal free end of the coil / core 910, so that the central axis extending through the groove 950 aligns with the axis extending through the hole 912. That is, the center of the groove 950 aligns with the center of the hole. In the illustrated example, both the groove 950 and the hole 912 are centered on the end axis A (see Figure 30B). The groove 950 defines two proximal free ends 918a and 918b on either side of the groove 950. A proximal concave end 919a is formed concave from the proximal free ends 918a and 918b and parallel to them. The groove wall 919b extends vertically and connects the proximal concave end 919a with the proximal free ends 918a and 918b. The proximal projections 915a and 915b are located between the groove 950 and the side of the coil / core 910. The groove 950 and the resulting proximal projections 915a and 915b can be of any size that allows the suture to be looped and maintained in place between the groove 950 and the hole 912. In an exemplary embodiment, the projections 915a and 915b are configured to be short and close enough to avoid snagging on the catheter 1010 when the docking device 1100 is being pushed, retrieved, or positioned.

[0158] In some cases, the proximal projections 915a and 915b can be aligned and have substantially the same thickness as the sides 914 and 916, respectively. In a preferred embodiment, the groove 950 is laser-cut into the coil / core 910. However, it will be understood that the groove can be formed in a variety of different ways, for example, by machining. The edges of the coil / core 910 can be rounded.

[0159] The suture 941 and / or retrieved suture / wire 1163 are inserted into the slit hole 912 and positioned in a loop around the groove 950, and secured by tying as a closed loop or otherwise. The suture 941 and / or retrieved suture / wire 1163 are looped through the groove 950 so firmly that they remain within the groove and do not shift from either proximal process 915a, 915b or move radially outward. In some cases, the groove can be of other shapes, for example, a cross shape, and the suture 941 and / or retrieved suture / wire 1163 can be tied to or otherwise secured in the cross-shaped groove to further prevent the suture 941 and / or retrieved suture / wire 1163 from shifting or moving.

[0160] As shown in Figure 30B, the distal end of the retrieved suture / wire 1163 can be attached to the suture 941 (or, as described above, the retrieved suture / wire 1163 can be directly attached to the docking device in the groove 950, and a separate suture 941 is not required or used). In one embodiment, the suture / wire 1163 can be arranged in a loop around the suture 941 or tied to the suture 941. When the released suture 1163 is pulled or otherwise retracted, tension is applied to the suture 941, which then pulls the docking device 900 toward the pusher tube 1165. Since the suture 941 remains looped around the slit hole 912 and groove, the line of tension F applied to the coil / core 910 by the release suture 1163 extends through the proximal concave end 919a and is substantially aligned with or biased to align with the central axis or longitudinal axis A of the coil / core 910 or its end (or biased in the direction of alignment). This alignment prevents the proximal end of the delivery device 900 from shifting away from the pusher tube 1165. Although the pusher tube 1165 and catheter 1010 are shown as relatively short compared to the proximal end of the docking device, the pusher tube 1165 and catheter 1010 can extend to any length.

[0161] In one embodiment, the retrieve suture / wire 1163 can be arranged in a loop around the docking device or tied directly to the docking device. When the release suture / wire 1163 is pulled or otherwise retracted, tension is applied to the docking device, thereby pulling the docking device 900 toward the pusher tube 1165. As the retrieve suture / wire 1164 remains tied around the slit hole 912 and groove 950, the tension F applied to the coil / core 910 by the release suture 1163 extends through the proximal concave end 919a and is substantially aligned with the axis A of the coil / core 910. This alignment prevents the end of the delivery device 900 from shifting away from the pusher tube 1165.

[0162] Returning to Figures 30A and 30B, the illustrated rectangular edges and corners or the grooves 950 and slit holes 912 can be rounded, for example. In the illustrated embodiment, the docking device 900 is similar to the docking device in Figure 25 and is shown as having a substantially flat or rectangular cross-section, but the proximal end can have any shape that fits into the delivery catheter. For example, the proximal end can be round or oval and may have a U-shaped groove or a otherwise rounded groove. Furthermore, the loop-shaped proximal end 1300 in Figures 29A to 29E may include a groove or channel.

[0163] Embodiments in Figures 30A and 30B may include any number of slits and grooves. For example, the proximal end of the coil / core 910 may have two grooves (or any number) and two slit holes (or any number) perpendicular to each other. A suture is passed through and secured in a loop through each of the slit holes and grooves. A release suture can then be attached to the two sutures at the center of the two grooves, thereby ensuring that the applied tension remains aligned between the coil / core 910 and the pusher tube 1165.

[0164] In this description, several aspects, advantages, and novel special mechanisms of embodiments of the present disclosure have been described herein. The disclosed methods, apparatus, and systems are not to be construed as limiting in any way. Rather, the present disclosure covers all novel, non-obvious special mechanisms and aspects of various disclosed embodiments, both individually and in various combinations and partial combinations of them. The methods, apparatus, and systems are not limited to any particular aspects or special mechanisms or combinations thereof, and may be combined, and the disclosed embodiments do not require the existence of any one or more particular advantages or the resolution of any problem.

[0165] While the operation of some embodiments of the disclosed embodiments is described in a specific order for presentation purposes, it should be understood that this method of description is reconfigurable unless a specific order is required by the specific language used. For example, operations or steps described sequentially may, in some cases, be reconfigured or performed simultaneously. Furthermore, for the sake of simplicity, accompanying figures may not illustrate various ways in which the disclosed methods can be used in conjunction with other methods. In addition, the description may use terms such as “provide” or “implement” to describe the disclosed methods. These terms are higher-level abstractions of the actual operations performed. The actual operations corresponding to these terms may differ depending on the specific implementation and will be identifiable to those skilled in the art.

[0166] Given the numerous possible embodiments to which the principles of this disclosure can be applied, it should be recognized that the illustrated embodiments are merely preferred examples and should not be considered to limit the scope of this disclosure. Rather, the scope of this disclosure is defined by the following claims. [Explanation of symbols]

[0167] 1, 100, 200, 300, 400, 500, 600, 1100 docking devices 10, 110, 1110 central area 20, 120, 1120 bottom area 21 Distal tip 21 Distal or lead tip 30, 130, 1130 upper area 31 Proximal tip 32 Major axis 33 Short diameter 40 Artificial valves 41. Expandable frame structure 42 Valve leaflets 50 Mitral valve 52 Left atrium 54 Left ventricle 56 Aortic valve 58 Aorta 62 Chordae tendineae 64 Commissure 66 Anterior leaflet 68 Posterior tip 140, 1140 stretch area 150 holes 210 Laser-cut tubes 211, 216, 217, 218 cuts 212 links 213, 218 teeth 214, 618 groove 215 End area 217 Opening 219 Locking Wire 219 Tension wire 222 Distal end 310, 510 Main Coil 320 Anchors 410, 610, 710, 810, 910 coils / cores 420 Coating 520 Friction element 530 High friction coating 622 Protrusion 712 Tip 714 Through-hole 716, 918 free end 718 The opposite end 720 Fixing hole 812 Ball-shaped tip 814 Gap 912 Slit hole 914, 916 Side 915a, 915b Proximal process 919a, 919b Proximal concave groove 920 Cover Layer 930 Suture thread 940 pull wire 941 Suture thread 950 Groove 1000 Guide Sheath, Introducer 1010 Delivery Catheter 1160 Wire Core 1162 holes 1163 Suture thread 1164 Fixed hole 1165 Pusher Tube 1170 Cover layer, low friction layer 1180 High friction layer, knitted layer 1182, 1184 Marker Bands 1200 Spherical proximal tip / end 1202 Spherical part 1204 Transition part 1206 Neck section 1210 Central aisle 1212 Side passage 1220 channels, annular recess 1230 Bore 1232 Bore Base 1240 Eyelets 1300 Loop-shaped proximal tip 1302 Flat longitudinal surface 1304 Distal end 1306 Connection point 1310 Inner loop surface 1312 Outer loop surface 1340 Bore 1800 left atrium 1810 Mitral valve 1830 Aortic wall 1840 Aorta 2700 End A1P1, A3P3 commissure

Claims

1. This is a system for transplanting a docking device to the natural valve. Delivery catheter and An elongated coil-shaped docking device having an end, A pusher device having a central lumen, wherein the pusher device is disposed within the delivery catheter, A retrieval line extending through the central lumen of the delivery catheter and coupled to the end of the coiled docking device, Equipped with, The system is configured such that when the recovery line is drawn, the end of the coiled anchor is pulled relative to the pusher device. The end and the recovery line are configured and coupled such that the tension resulting from the pulling is biased so as to be substantially aligned with the central axis of the end of the coiled docking device. The coiled docking device is Having a first thickness and at least one central winding defining the central winding diameter, An extended portion having a length extending from the proximal end of at least one central winding, and an extended portion having a second thickness smaller than the first thickness, A proximal winding extending from the proximal end of the extension portion, having a third thickness greater than the second thickness, A system equipped with these features.

2. This is a system for transplanting a docking device to the natural valve. Delivery catheter and An elongated coil-shaped docking device having an end, A pusher device having a central lumen, wherein the pusher device is disposed within the delivery catheter, A retrieval line extending through the central lumen of the delivery catheter and coupled to the end of the coiled docking device, Equipped with, The system is configured such that when the recovery line is drawn, the end of the coiled anchor is pulled relative to the pusher device. The end and the recovery line are configured and coupled such that the tension resulting from the pulling is biased so as to be substantially aligned with the central axis of the end of the coiled docking device. The coiled docking device is At least one central winding that defines the central winding diameter, A lower winding extending from the at least one central winding defines a diameter larger than the central winding diameter, An upper winding connected to the at least one central winding, comprising an upper winding shaped to have a first diameter along a first axis and a second diameter along a second axis, A system in which the first shaft diameter is greater than the central winding diameter, and the second shaft diameter is greater than the central winding diameter and smaller than the lower winding diameter.

3. The system according to claim 1 or 2, wherein the end is configured to align at least a longitudinal portion of the recovery line with the central axis.

4. The system according to claim 1 or 2, wherein the recovery line extends through a central passage at the tip of the end of the docking device, and the central passage is aligned with the central axis.

5. The docking device further comprises a spherical tip, according to claim 1 or 2.

6. The system according to claim 5, wherein the spherical tip receives the retrieval wire through a passage aligned with the central axis of the end of the coiled docking device.

7. The system according to claim 6, wherein the spherical proximal tip is provided with an annular groove in the transition portion of the spherical proximal tip.

8. The system according to claim 1 or 2, wherein the distal end of the pusher device is configured to engage with a spherical surface at the end of the coiled anchor.

9. The system according to claim 1 or 2, wherein the end of the docking device has a tip including a loop, and the retrieval line is connected to the loop.

10. The system according to claim 1 or 2, wherein the end of the docking device has a tip including a groove, and the retrieved suture is coupled to the end in the groove.

11. The system according to claim 1, wherein the coiled docking device has a distal winding on the end of the coiled docking device opposite to the end, the distal winding having the first thickness and defining a diameter larger than the central winding diameter.

12. The system according to claim 1, wherein the end of the coiled docking device is located at the proximal end of the proximal winding.

13. The system according to claim 1, wherein the coiled docking device is configured to be implanted at the site of a natural valve, and at least a portion of the coiled docking device is positioned within the cardiac chambers of the heart and around the leaflets of the natural valve.

14. The system according to claim 13, wherein the coiled docking device is configured to be implanted at the site of a natural mitral valve, and at least a portion of the coiled docking device is positioned in the left ventricle and around the mitral leaflets of the natural mitral valve.

15. The system according to claim 13, wherein the coiled docking device is configured to be implanted at the site of a natural tricuspid valve, and at least a portion of the coiled docking device is positioned in the left ventricle and around the tricuspid leaflets of the natural tricuspid valve.

16. The system according to any one of claims 1 to 15, further comprising a cover layer made of a biocompatible material, wherein the cover layer surrounds at least a portion of the coiled anchor.

17. The aforementioned cover layer is a low-friction cover layer. The low-friction cover layer has a distal end and a proximal end, surrounds the coiled docking device, extends along the length of the coiled docking device, beyond the distal end of the coiled docking device, and beyond the proximal end of the coiled docking device. The system according to claim 16, wherein the low-friction cover layer tapers to a rounded tip at its distal end.

18. The system according to claim 16, further comprising a friction-enhancing element having a second cover layer surrounding at least a portion of the cover layer and extending along the at least portion thereof, wherein the second cover layer has a coefficient of friction of at least 1.

19. The system according to claim 18, wherein the second cover layer is a knitted material.

20. The coiled docking device is A hollow tube having a proximal end and a distal end, Multiple cuts that penetrate each part of the hollow tube, A wire having length, a proximal end, and a distal end, Equipped with, The distal end of the wire is fixed to the distal end of the hollow tube, and the proximal end of the wire is fixed to the proximal end of the hollow tube. The system according to any one of claims 1 to 19, wherein the length of the wire extends through the hollow tube and applies radially inward tension to the hollow tube.

21. The system according to claim 20, wherein the notches have a pattern and shape that incorporates both longitudinal and transverse notches that form teeth and grooves in the hollow tube.

22. The system according to any one of claims 1 to 21, wherein the coiled docking device includes a core, and the distal end of the core has a rectangular cross-section and a distal wound ring-shaped tip.

23. The system according to any one of claims 1 to 21, wherein the coiled docking device includes a core, and at least one end of the core has a ball-shaped tip.

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