Heart valve docking devices and systems

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 benefit of U.S. Patent Application No. 15 / 902,956, filed on Feb. 22, 2018, which is a continuation - in - part of U.S. Patent Application No. 15 / 682,287, filed on Aug. 21, 2017, which claims the benefit of U.S. Provisional Patent Application No. 62 / 395,940, filed on Sep. 16, 2016 and U.S. Provisional Patent Application No. 62 / 380,117, filed on Aug. 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 installation procedures related to the implantation of 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] Referring first 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 within the left ventricle substantially rises, which serves to prompt the mitral valve to close. Since the pressure difference between the left ventricle and the left atrium during this time is large, a large pressure is exerted on the mitral valve, and there is a possibility that the valve leaflets of the mitral valve deviate or evert into the atrium. Therefore, a series of chordae tendineae 62 connect the valve leaflets of the mitral valve to the papillary muscles located on the wall of the left ventricle. During the contraction of the left ventricle, both the chordae tendineae and the papillary muscles are under tension to hold the valve leaflets in the closed position and prevent the valve leaflets from stretching toward the left atrium. This helps to prevent the backflow of oxygenated blood into the left atrium. The chordae tendineae 62 are schematically shown in both the cross-section of the heart in FIG. 1 and the top view of the mitral valve in FIG. 2.

[0005] The general shape of the mitral valve and its valve leaflets as seen from the left ventricle is shown in FIG. 2. Junction portions 64 are located at each end of the mitral valve 50 where the anterior leaflet 66 and the posterior leaflet 68 converge. Various complications of the mitral valve can, in some cases, result in life-threatening heart failure. One form of valvular heart disease is mitral valve regurgitation or mitral valve leakage, which is characterized by abnormal leakage of blood flowing from the left ventricle through the mitral valve into the left atrium. This can occur, for example, when the natural mitral valve leaflets fail to completely join due to left ventricular dilation, resulting in leakage, when the natural valve leaflets are damaged, or when there is weakening (or damage) of the chordae tendineae and / or papillary muscles. In such situations, it may be desirable to repair the mitral valve or replace the function of the mitral valve with the function of an artificial heart valve.

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

[0007] One of the most significant obstacles to mitral valve replacement is that the valve is effectively fixed or retained in the mitral position by receiving a large circulatory load. As pointed out above, another problem with mitral valve replacement is the size and shape of the natural mitral valve loop, as can be seen in Figure 2. The aortic valve is closer to a circular or cylindrical shape compared to the mitral valve. Furthermore, both the mitral valve and the tricuspid valve are larger and more elongated than the aortic valve, and are more difficult and anomalous sites for implanting a replacement valve having a generally circular or cylindrical valve frame. If a good seal is not established around the valve, an overly small circular artificial valve may leak around the implant (i.e., paravalvular leak), while an overly large circular artificial valve may stretch and damage the narrower part of the natural mitral valve loop. Additionally, often, for example, aortic valve replacement is required due to aortic valve stenosis, in which case the aortic valve stenoses due to calcification or other hardening of the natural valve leaflets. Thus, the aortic valve loop generally forms a fixation site for a smaller, more rigid, and more stable artificial valve than the mitral valve loop, and the mitral valve loop is larger and non-circular compared to the aortic valve loop. In the case of mitral valve regurgitation, the likelihood of forming such a good fixation site is low. Additionally, the presence of chordae tendineae and other biological structures in the mitral position can form obstacles that are much more serious problems in properly fixing the device in the mitral position.

[0008] Other obstacles to effective mitral valve replacement can arise due to the mitral valve receiving a large circulatory load and the need to establish a sufficiently strong and stable fixation and retention. Additionally, even a slight misalignment of the valve can interfere with blood flow in the heart valve or other sites or have other adverse effects. SUMMARY OF THE INVENTION MEANS FOR SOLVING THE PROBLEM

[0009] This summary is for the purpose of presenting some examples and is not intended to limit the scope of the invention. For example, in the special mechanisms included in the examples of this summary, there are also special mechanisms that are not required in the claims unless explicitly described in the claims. Further, the special mechanisms to be described can be combined in various ways. The description herein relates to systems, assemblies, methods, devices, apparatuses, combinations, etc. that may be utilized to treat valves in animals. The various special mechanisms and steps described elsewhere in this disclosure may be included in the examples outlined herein.

[0010] One way to apply existing circular or cylindrical transcatheter valve technology to non-circular valve replacements (e.g., mitral valve replacement, tricuspid valve replacement, etc.) is to use an anchor (e.g., a mitral anchor) or a docking device or a docking station that forms or otherwise constructs a docking site that is more circular at the natural valve position to hold such an artificial valve. Thus, an existing expandable transcatheter valve developed for the aortic position, or a similar valve slightly modified to more effectively mimic the mitral valve function, can be reliably implanted by such a docking device located in the natural valve loop (e.g., the 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 through the docking device between the folded positions and placed, and then expanded, for example, via self-expansion (e.g., in the case of a valve composed of NiTi or another shape memory material), balloon expansion, or mechanical expansion, thereby radially pressing the frame of the artificial valve between the docking device and / or the tissue to hold the valve in place. The docking device can also be delivered minimally invasively or less invasively via the same or a similar transcatheter technique used to deliver the transcatheter valve heart valve, thereby preferably eliminating the need for a completely separate procedure for implanting the docking device prior to delivering the artificial valve.

[0011] Accordingly, it is desirable to provide devices and methods that can be utilized to facilitate such valve docking or anchoring. 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 adapted to be held therein. These devices and methods can more securely hold the artificial valve and can 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, such as mitral valve replacement, tricuspid valve replacement, pulmonary valve replacement, or aortic valve replacement, to more securely and firmly anchor and hold a valve implant in place of the native valve loop in such positions.

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

[0013] Any of the coiled anchors described herein can include an extension having a length extending from the upper end of at least one central coil to an upper coil or stabilizing coil. The extension can have a smaller thickness compared to other portions of the coiled anchor, such as at least one central coil, upper coil, lower coil, etc. The extension can extend perpendicularly at an angle of 60 - 120 degrees, 70 - 110 degrees, 80 - 100 degrees, 90 degrees with respect to at least one central coil.

[0014] Various docking devices for docking an artificial valve at the location of a natural valve of the heart can have a coiled anchor having a proximal tip and a distal tip (e.g., a coiled anchor that can be the same or similar to other coiled anchors described in this disclosure). The coiled anchor can include at least one central coil (e.g., a full central coil or a partial central coil, which can be the same or similar to other central coils or functional coils described in this disclosure). The at least one central coil can have a first thickness and can define a central coil diameter. Any of the coiled anchors described herein can also include an extension having a length extending from an upper end of the at least one central coil. The coiled anchor can also include an upper coil (e.g., an upper coil or a stabilizing coil / spiral that can be the same or similar to other upper coils described in this disclosure) extending from an upper end of the extension. The extension can have a second thickness that is less than the first thickness. The upper coil can have a third thickness that is greater than the second thickness. As described above, the coiled anchor can be configured to be implanted at the location of a natural valve (e.g., a natural mitral valve, tricuspid valve, etc.), and at least a portion of all or part of the central coil of the coiled anchor is disposed within a heart chamber (e.g., the left ventricle) of the heart and around the valve leaflets (e.g., mitral valve leaflets) of the natural heart valve.

[0015] A variety of docking devices for docking an artificial valve at the location of a natural valve of the heart can also have a coiled anchor (which can be the same or similar to other coiled anchors described in the present disclosure) having a proximal tip and a distal tip, and at least one central coil (e.g., a full central coil or a partial central coil, which can be the same or similar to other central coils / coils or functional coils / coils described in the present disclosure) that defines a diameter. The coiled anchor can also have an upper coil connected to the at least one central coil. A cover layer can surround the coiled anchor along all or at least a portion of the at least one central coil. The cover layer can be connected to the coiled anchor. At least one friction enhancement layer can be disposed on the coiled anchor and / or the cover layer. The at least one friction enhancement layer can be disposed on at least a portion of the at least one central coil. The coiled anchor can be configured such that no portion of the upper coil is covered by the friction enhancement layer. The coiled anchor can also be configured to be implantable at the location of a natural valve (e.g., a natural mitral valve, etc.), and at least a portion of at least one central coil of the coiled anchor is disposed within a cardiac chamber (e.g., the left ventricle) of the heart and around the valve leaflets of the natural valve.

[0016] Any of the coiled anchors of any of the docking devices described herein can include one or more cover layers surrounding all or at least a portion of the coiled anchor or the core of the coiled anchor. For example, the cover layer can surround all or at least a portion of at least one central turn (or all of the central turns / coils or functional turns / coils of the coiled anchor) and / or other portions of the coiled anchor. The cover layer can be connected to the coiled anchor in various ways. The cover layer can be a high-friction cover layer or a low-friction cover layer, or both a low-friction cover layer and a high-friction cover layer can be used together. The low-friction cover layer can 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 the distal tip. The low-friction cover layer can form a tapered tip or a rounded tip at its distal end and / or proximal end. A high-friction cover layer or a cover layer with a higher coefficient of friction (e.g., a cover layer with a higher coefficient of friction than the low-friction cover layer) can surround a portion of the low-friction cover layer and / or a portion of the coiled anchor (all or a part of at least one central turn).

[0017] Any of the coiled anchors described herein can include at least one friction enhancement element or a plurality of friction enhancement elements. The at least one friction enhancement element can be disposed on all or a part of the coiled anchor or on the coating / layer of the coiled anchor. The at least one friction enhancement element can be a plurality of bulges on the surface of the coiled anchor or on the surface of the coating, or can include a plurality of bulges on the surface of the coiled anchor or on the surface of the coating. The bulges can be made of PET, polymer, cloth, or another material. The bulges can extend along at least a part of the central turn / coil or along a length of the coiled anchor or the coating.

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

[0019] A system for implanting a docking device at the location of a natural valve of the heart can include a docking device (e.g., any docking device described above or elsewhere within the present disclosure). The docking device can include an opening or bore, and the system can include a suture passed through the opening or bore. The system can also include a delivery catheter and a pusher device disposed within the delivery catheter. The pusher device can include a central lumen that receives or through which the suture passes. The pusher device and the suture are such that when the suture is pulled, the 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 can be disposed within the central lumen such that when the suture and / or the pusher device are pulled in a proximal direction relative 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 at the location of a natural valve of the heart can have a coiled anchor that includes a hollow tube. The hollow tube can have a proximal locking special mechanism and a distal locking special mechanism. A plurality of cuts can be provided that penetrate each part of the tube. The cuts can have a pattern and shape incorporating one or both of a longitudinal cut and a transverse cut. When the cuts have a pattern and shape incorporating both a longitudinal cut and a transverse cut, they can form teeth and grooves in the hollow tube. The docking device can also have a wire, and the distal end of the wire can be fixed to the distal locking special mechanism. A certain length of the wire (e.g., the entire length or a part of the wire) can extend through the hollow tube and can apply a tension radially inwardly to the hollow tube. The hollow tube is configured to at least partially surround the valve tip of the natural mitral valve and form a docking surface for an expandable artificial valve.

[0021] The methods used to implant a docking device for an artificial valve in place of a native heart valve can include various steps (e.g., any of the steps described throughout this disclosure). The docking device implanted by these methods can be any of the docking devices described herein. For example, a docking device implantable by these steps can have a coiled anchor having at least one full or partial wrap defining a central diameter, an extension having a length extending from an upper end of at least one central wrap, and an upper wrap extending from an upper end of the extension. The distal end of a delivery catheter can be positioned within a first cardiac chamber of the heart (e.g., the left ventricle). Optionally, the delivery catheter can be advanced and positioned through a guide sheath that has already been implanted. The delivery catheter can include a docking device in a first configuration. The distal end of the docking device can be advanced from the delivery catheter, whereby the docking device assumes a second configuration upon advancement and / or implantation. The docking device can be advanced through a valve loop (e.g., a native mitral valve loop) into a second cardiac chamber of the heart (e.g., the left ventricle), whereby the distal tip loosely surrounds any chordae tendineae and native valve leaflets of the native valve (e.g., the mitral valve). The extension of the docking device can be advanced, whereby the upper end of the extension is positioned within the first cardiac chamber (e.g., the left atrium). The upper portion of the docking device can be advanced and released within the first cardiac chamber (e.g., the left atrium), whereby the upper portion contacts the first cardiac chamber wall (e.g., the left atrial wall). A replacement artificial valve can be implanted within the docking device. For example, the replacement valve can be inserted into the inner space defined by the docking device in a second configuration. The replacement valve can expand radially until a holding force acts between the replacement valve and the docking device to hold the replacement valve in a stable position. Native valve leaflets or other tissue can be clamped between the delivery device and the artificial valve.

[0022] Valve replacement can be achieved by docking an expandable transcatheter heart valve into the native 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 artificial valve. Accordingly, embodiments of the present invention provide a more robust method for implanting a replacement heart valve at sites such as the native mitral valve loop where the valve loop itself may be non-circular or may have a variable shape in some cases.

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

[0024] The system is configured to facilitate pulling the docking device relative to the pusher device and / or pulling the docking device into the delivery catheter without the end of the docking device being caught on the end of the pusher device and / or the delivery catheter or in a T-shape at the end of the pusher device and / or the delivery catheter. For example, the system, e.g., the end and the retrieval line, is configured such that pulling the retrieval line causes the end of the coiled anchor to be pulled relative to the pusher device and / or the delivery catheter to assist in guiding the end of the coiled anchor and the docking device into the delivery catheter. The proximal portion or tip of the end can be curved to assist in aligning the end with the pusher tube and / or the delivery catheter for retrieval. The end and the retrieval line can also be biased such that the tension from pulling is substantially aligned with the central axis of the end of the coiled docking device or configured and coupled such that pulling the retrieval line aligns the tension with the central axis of the end of the coiled docking device. The tension can bias the central axis of the end to align with the axis of the pusher device and / or the delivery catheter or be aligned with the axis of the pusher device and / or the delivery catheter, whereby, for example, the end can be aligned to be pulled into the delivery catheter.

[0025] The end can be configured to align at least a lengthwise portion of the retrieval line along the central axis. The retrieval line can be arranged to extend through a central passage at the tip of the end of the docking device. The central passage can be aligned with the central axis 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 the retrieval wire 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 the spherical surface at the end of the coiled anchor, and can draw some part of the spherical tip into the lumen of the pusher device.

[0027] The end of the docking device can comprise a tip having a loop, and the retrieval wire 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 the 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 winding 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 the end opposite the proximal coil or upper coil and the end of the coiled docking device. The distal coil or lower coil can have the first thickness and can define a diameter larger than the central winding 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 location of the native valve, and at least a portion of the coiled docking device is disposed within the cardiac chamber of the heart and around the valve leaflets of the native valve. The coiled docking device can be configured to be implanted at the location of the native mitral valve, and at least a portion of the coiled docking device is disposed within the left ventricle and around the mitral valve leaflets of the native mitral valve. The coiled docking device can be configured to be implanted at the location of the native tricuspid valve, and at least a portion of the coiled docking device is disposed within the right ventricle and around the tricuspid valve leaflets of the native tricuspid valve.

[0031] The system and / or the coiled docking device can include a cover layer comprising a biocompatible material, the cover layer surrounding at least a portion of the coiled anchor. The cover layer can be a low-friction cover layer having a distal end and a proximal end. The cover layer surrounds the coiled docking device and can extend along a length of the coiled docking device beyond the distal tip of the coiled docking device and beyond the proximal tip of the coiled docking device, and the low-friction cover layer tapers to a rounded tip at its distal end. The system and / or the coiled docking device can include a friction-enhancing element, the friction-enhancing element comprising a second cover layer surrounding 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 in this specification). The second cover layer can be a braided material.

[0032] The coiled docking device can include at least one central coil that defines a central coil diameter, a distal coil or a lower coil extending from at least one central coil that defines a distal coil diameter or a lower coil diameter greater than the central coil diameter, and an upper coil or a proximal coil connected to the at least one central coil. The upper coil or the proximal coil is shaped to have a first diameter along a first axis and a second diameter along a second axis. The first axis diameter can be greater than the central coil diameter, and the second axis diameter can be greater than the central coil diameter and less than the lower coil diameter or the distal coil diameter.

[0033] The coiled docking device can include a hollow tube having a proximal end, a distal end, and a plurality of cuts at various portions of the tube. The coiled docking device can also include a wire having a 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 and apply a radially inward tension to the hollow tube. The cuts can have a pattern and shape incorporating both longitudinal and transverse cuts that form teeth and grooves in the hollow tube.

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

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

[0036] In one embodiment, there is provided a docking device for docking an artificial valve at the location of a natural valve of the heart, the docking device being capable of including any of the special mechanisms and components described hereinabove and elsewhere herein with respect to the docking device. For example, the docking device can include or be a coiled docking device having an end portion that includes a central axis. The end portion of the docking device can be configured such that a retrieval suture connected to the end portion is biased and the line of force applied to the retrieval suture by the tension is aligned with the central axis.

[0037] A method of retrieving a coiled docking device from within the heart can include the steps of pulling a retrieval line to draw an end portion of the coiled docking device against a pusher device and / or into a delivery catheter. The end portion of the coiled docking device can be configured as any of the end portions described hereinabove or elsewhere herein. For example, the end portion can be configured to bias the retrieval line such that the tension applied by said pulling is aligned with the central axis of the end portion of the coiled docking device. The method can include the step of drawing the pusher device and / or the end portion of the coiled docking device into the delivery catheter.

[0038] Further special mechanisms and advantages of the present invention will become apparent from the description of the embodiments using the accompanying drawings.

Brief Description of the Drawings

[0039]

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DETAILED DESCRIPTION OF THE INVENTION

[0040] In this specification, various anchors or docking devices (e.g., coiled anchors or docking devices) are disclosed and can be used with a transcatheter heart valve (THV) that can be expanded at a natural valve loop (e.g., a mitral valve loop or a tricuspid valve loop) to more securely implant and hold an artificial valve at the implantation site. The fixation / docking device according to an embodiment of the present invention forms or constitutes a valve loop that is closer to circular and / or more stable at the implantation site, and at the implantation site, an artificial valve having a circular or cylindrical valve frame or stent can be expanded or implanted in other ways. The fixation / docking device not only constitutes a fixation site for the artificial valve but also can have a size and shape that constricts or pulls a natural valve (e.g., mitral valve, tricuspid valve, etc.) biological structure radially inward. In this way, 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 the valve loop, and thus the stretching from the natural valve (e.g., mitral valve) loop. Some embodiments of the fixation or docking device further include, for example, special mechanisms that are shaped and / or modified to better hold 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, a replacement valve can be more securely implanted and held at various valve loops, including those of mitral valve loops that do not have a natural circular cross-section.

[0041] Exemplary anchor / docking devices are shown in FIGS. 3-5. FIG. 3 shows a perspective view of the anchor or docking device 1, FIG. 4 shows a side view of the anchor / docking device 1, and FIG. 5 shows a top view of the anchor / docking device 1. The anchor / docking device can be wound in a coil shape (e.g., including a coiled portion) as shown in these figures.

[0042] Docking device 1 includes a coil having a plurality of turns extending along the central axis of docking device 1. The coil can be continuous and can extend generally helically and can have cross-sections of various different sizes and shapes, as will be described in more detail below. The docking device 1 shown in FIGS. 3-5 is configured to fit most well in the mitral position, but in other embodiments can be shaped the same or differently to better accommodate other native valve positions.

[0043] 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 serves as a primary loading or holding region for holding an expandable prosthetic valve or THV that can expand when the docking device 1 and the valve prosthesis are implanted into the patient's body. Other embodiments of docking device 1 can have a central region 10 with more or fewer coil turns depending on the patient's anatomy, 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 may also be referred to as "functional coils". This is because the characteristics of these coils contribute most to the amount of holding force that occurs between the valve prosthesis, the docking device 1, and the native mitral valve leaflets and / or other anatomical structures.

[0044] Various factors can contribute to the total holding force between the docking device 1 and the prosthetic valve held within the docking device. The main 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 various numbers of coil turns. The number of functional turns can be from just over a half turn to 5 turns, or from a full 1 turn to 5 turns, or more. In one embodiment with a full 3 turns, an additional half turn is included in the ventricular portion of the docking device. In another embodiment, a total of 3 full turns can be had within the docking device. In one embodiment, in the atrial portion of the docking device, it can be from a half turn to three quarters of a turn or from half of a circle to three quarters of a circle. A range of turns is provided, but as the number of turns within the docking device decreases, the dimensions and / or materials of the coil and / or the wire forming the coil can also be changed to maintain an appropriate holding force. For example, the diameter of the wire can be made larger than the diameter of the functional coil turns in a docking device having fewer coils. A plurality of coils can be provided in the atrium and ventricle.

[0045] The size of the functional coil or the coil in 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 in the central region 10 of the docking device 1) is smaller than the outer diameter of the expandable heart valve, such that when the artificial valve is expanded in the docking device, additional radial tension or holding force acts between the docking device and the artificial valve to hold the artificial valve in place. The holding force required to properly implant the artificial valve varies based on the size of the artificial valve and the ability of the assembly to handle a mitral pressure of about 180 mmHg. For example, based on bench tests using an artificial valve with an outer diameter of 29 mm at expansion, at least 18.5 N of holding force is required between the docking device and the artificial valve to securely hold the artificial valve within the docking device and resist or prevent mitral regurgitation or leakage. However, in this example, to meet the 18.5 N holding force requirement with statistical confidence, the target average holding force needs to be substantially increased, for example, to about 30 N.

[0046] In many embodiments, the holding force between the docking device and the valve prosthesis is significantly reduced when the difference between the outer diameter of the artificial valve in the expanded state and the inner diameter of the functional coil is less than about 5 mm. The reason is that this reduced size difference is too small to generate sufficient holding force between the components. For example, as in one embodiment, when an artificial valve with an outer diameter of 29 mm at expansion is expanded within a set of coils with an inner diameter of 24 mm, the observed holding force is about 30 N, but when the same artificial valve is expanded within a set of coils with an inner diameter of 25 mm (e.g., 1 mm larger), the observed holding force drops significantly to 20 N. Therefore, for this type of valve and docking device, to generate sufficient holding force between the docking device and the 29 mm artificial valve, it is necessary to make the inner diameter of the functional coil (e.g., the coil in the central region 10 of the docking device 1) 24 mm or less. Generally, the inner diameter of the functional coil (e.g., the central region 10 of the docking device 1) needs to be selected to be at least about 5 mm smaller than the artificial valve selected for implantation. However, since various factors can affect the holding force, if other sizes or size ranges are used, other special mechanisms and / or characteristics (e.g., friction-enhancing special mechanisms, material properties, etc.) can be used to perform holding better. Further, as the size of the inner diameter of the functional coil or the central region 10, for example, to at least partially offset the mitral regurgitation caused by the stretching of the natural valve loop as a result of left ventricular hypertrophy and at least partially counter the mitral regurgitation, a size can be selected that attracts the mitral biological structure more.

[0047] Note that the above-described desired holding force is applicable to embodiments regarding mitral valve replacement. Therefore, other embodiments of the docking device used for replacement of other valves can have different size relationships based on the desired holding force for valve replacement at their respective positions. Further, the size difference can vary based on, for example, the materials used for the valve and / or the docking device, whether there are other special mechanisms for preventing the expansion of the functional coil or enhancing friction / locking, and / or various other factors.

[0048] In an embodiment where the docking device 1 is used at the mitral position, the docking device can first be advanced to the native mitral valve loop and then set to the desired position prior to implanting the THV. The docking device 1 is preferably flexible and / or made of a shape memory material, whereby the coil of the docking device 1 can be straightened to allow delivery via a transcatheter approach. In another embodiment, the coil can be made of another biocompatible material such as stainless steel. Some of the same catheters and other delivery instruments 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 delivered from the left atrium, transseptally through the atrial septum and across the atrium to the mitral position, or to the mitral position via one of various other known access points or procedures. FIGS. 6 and 7 illustrate some of the steps during delivery of the docking device 1 to the mitral position using a transseptal approach, advancing the guide sheath 1000 through the vasculature to the right atrium and then through the atrial septum of the heart to the left atrium, and advancing the delivery catheter 1010 through the guide sheath 1000 that reaches into the left atrium through the vasculature, right atrium, and septum. As can be seen in FIG. 6, the docking device 1 can be advanced through the distal end of the delivery catheter 1010 positioned within the left atrium (e.g., positioned at the commissure) and through the native mitral valve loop, e.g., at the commissure of the native mitral valve, into the left ventricle. The distal end of the docking device 1 then loops around the mitral biological structure (e.g., native mitral valve leaflets and / or chordae tendineae) located within the left ventricle, whereby all or at least some of the native valve leaflets and / or chordae tendineae are surrounded and collected by the coil of the docking device 1 and held within the coil (e.g., surrounded by the coil).

[0050] However, in order to increase the holding force of the prosthetic valve, the functional coil / winding or the diameter of the coil / winding in the central region 10 of the docking device 1 is maintained relatively small (e.g., in one embodiment, the central region 10 can have an inner diameter of about 24 mm (e.g., ±2 mm) or another diameter smaller than the THV and / or the native valve loop), so it may be difficult to advance the docking device 1 to the desired position relative to the native mitral valve loop around the existing valve tip and / or chordae tendineae. This is particularly true when the entire docking device 1 is given the same small diameter as the central region 10. Thus, referring again to FIGS. 3-5, the docking device 1 can have a distal region or lower region 20 that constitutes the induction coil / winding (or tip ventricular coil / winding) of the docking device 1, and the induction coil / winding has a diameter larger than the diameter of the functional coil / winding in the central region 10 or the diameter of the coil / winding.

[0051] The special mechanism of the mitral biological structure within the left ventricle has variable dimensions and can have a maximum width of approximately 35 mm to 45 mm along the long axis. Thus, as the diameter or width of the induction coil / winding in the lower region 20 (e.g., ventricular coil / winding), a larger diameter or width can be selected to more easily manipulate the distal tip or induction tip 21 of the docking device 1 and rotate around the special mechanism of the mitral biological structure (e.g., valve leaflets and / or chordae tendineae). Various sizes and shapes are possible. 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 opposite points of the coil / winding. For example, with respect to the induction coil / winding, the diameter can be measured from the distal tip 21 to the opposite side in the same way as when the distal lower region 20 or the induction coil / winding forms a complete rotation, or the diameter can be considered twice the radius of curvature of the induction coil / winding. In one embodiment, the lower region 20 (e.g., induction coil / winding) of the docking device 1 has a diameter (e.g.,) of approximately 43 mm (e.g., ±2 mm), in other words, the radius of curvature in the induction coil / winding can be approximately 21.5 mm. Making the size of the induction coil / winding larger than that of the functional coil can help guide the coil more easily around and / or inside the chordae tendineae, and most importantly, can help properly guide around both natural valve leaflets of the mitral valve. After the distal tip 21 is manipulated around the desired mitral biological structure, the remaining coils of the docking device 1 can also be guided around the same special mechanism. Since the sizes of the other coils are reduced, the enclosed biological structure 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 interference or obstruction of blood flow along the left ventricular outflow tract by the lower region 20. For example, in one embodiment, the enlarged lower region 20 extends over approximately one-half loop or rotation.Since the lower region 20 has this relatively short length, the prosthetic valve is expanded within the docking device 1, and due to the size difference between the docking device and the prosthetic valve, the coil of the docking device 1 begins to unwind slightly, and the lower region 20 is also drawn in and shifted slightly. In this example, after the expansion of the prosthetic valve, instead of continuing to protrude from the functional coil, the lower region 20 can have the same size as the functional coil of the docking device 1 and can be substantially aligned with the functional coil, thereby reducing potential blood flow obstruction. Other docking device embodiments can have longer or shorter lower regions depending on the particular application.

[0052] The docking device 1 of FIGS. 3 - 5 also includes an enlarged proximal or upper region 30 that constitutes a stabilizing coil / winding of the docking device 1 (which can be, for example, an atrial coil / winding). When the docking device 1 is positioned in the desired position and orientation at the native mitral valve loop, the entire docking device 1 is released from the delivery catheter 1010, and then the prosthetic valve (for example, a THV) is sent to the docking device 1. During the transition or intermediate stage of the implantation procedure, that is, between deploying and releasing the docking device 1 and finally sending the prosthetic valve, for example, the coil can be displaced from its desired position or orientation and / or detached by normal cardiac function. If the docking device 1 is displaced, in some cases, the implantation may become unsafe, misalignment may occur, and / or other placement problems of the prosthetic valve may occur. A stabilizing special mechanism or coil can be used to help stabilize the docking device in the desired position. For example, the docking device 1 can be configured to be disposed within the circulatory system (for example, within the left atrium), and thereby include an upper region 30 having an enlarged stabilizing coil / winding (for example, an enlarged atrial coil / winding) that can stabilize the docking device. For example, the proximal or upper region 30 or the stabilizing coil / winding can be configured to abut or press against the wall of the circulatory system (for example, the wall of the left atrium) to improve the ability of the docking device 1 to remain in the desired position before implanting the prosthetic valve.

[0053] In the illustrated embodiment, the stabilization coil / winding (e.g., atrial coil / winding) at the upper region 30 of the docking device 1 extends over substantially a complete turn or revolution and terminates at the proximal tip 31. In other embodiments, the stabilization coil / winding (e.g., atrial coil) can extend over more or fewer turns or revolutions, depending, for example, on the desired amount of contact between the docking device and the circulatory system (e.g., with the wall of the left atrium) for each particular application. The radial size of the stabilization coil / winding (e.g., atrial coil) at the upper region 30 can be made significantly larger than the size of the functional coil in the central region 10, such that the stabilization coil / winding (e.g., atrial coil) spreads or extends far enough outward to contact the wall of the circulatory system (e.g., the wall of the left atrium). For example, in one embodiment, the major diameter 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 tapers in width toward the native mitral valve loop. Thus, when the docking device 1 is properly deployed in the mitral position, the stabilization coil / winding (e.g., atrial coil) at the upper region 30 contacts and presses against the wall of the left atrium, helping to maintain or hold the docking device 1 in a relatively high desired position and orientation and 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 therein. After the prosthetic valve (e.g., 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 the stabilization coil / winding.

[0054] In some cases, the stabilizing coil / winding in the upper region 30 (e.g., the atrial coil) is non-circular and, in the illustrated embodiment, is offset and arranged in an elliptical or oval shape. As shown in FIG. 5, an elliptical or other non-circular stabilizing coil / winding (e.g., the atrial coil) can have a major axis 32, D1 (i.e., the maximum width of the coil winding), a minor axis 33, and D2 (i.e., the width between the minimum ends). The width / diameter can be selected based on the size of a biological structure that is part of the circulatory system (e.g., based on the size of the human left atrium). The major axis (or maximum width) D1 can be in the range of 40 mm to 100 mm, or in the range of 40 mm to 80 mm or 40 mm to 75 mm. The minor axis (or minimum width) D2 can be in the range of 20 mm to 80 mm or 20 mm to 75 mm. The major axis / width D1 of the stabilizing coil / winding (e.g., the atrial coil) can be about 50 mm, while the diameter / width D2 along the minor axis of the stabilizing coil / winding (e.g., the 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 by looking at the top view of the docking device 1 in FIG. 5. In other embodiments, offsetting the upper region of the docking device can be implemented in many ways. For example, the stabilizing coil / winding in the upper region 30 (e.g., the atrial coil) can remain substantially circular, and / or the stabilizing coil / winding can be offset in one direction, thereby shifting the center of the upper region from the center of the other parts of the docking device. By offsetting the shape of the upper region 30 of the docking device 1 in this way, for example, the contact between the docking device 1 and the wall of the left atrium or other biological structure can be increased in the radial direction where the upper region 30 extends farthest from the other parts of the docking device 1. The stabilizing coil / winding (e.g., the atrial coil) can be offset such that, when viewed from above (FIG. 20), the center of the stabilizing coil / winding (e.g., the atrial coil) is offset from the center of the functional coil by about 50% to 75% of the diameter of the functional winding. The stabilizing winding of the coil (e.g., the atrial winding) can be made flexible and can bend inward.Thereby, a biological structure (e.g., the left atrial biological structure) is accommodated, and the stabilization coil / winding (e.g., the atrial coil) may have a major axis or a minor axis that is larger than the atrium or the other biological structure itself.

[0055] Importantly, the docking device 1 can be rotated or otherwise positioned 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 within the native mitral valve, it is oriented towards the wall of the left atrium that faces or abuts against the left ventricular outflow tract, thereby reducing the amount of pressure applied by the docking device 1 to that portion of the atrial wall. In this way, the amount of displacement of that portion of the wall towards the left ventricular outflow tract is also reduced, and thus the enlarged upper region 30 can avoid interfering with, obstructing, or in some cases affecting the blood flow through the left ventricular outflow tract.

[0056] Due to the enlarged upper region 30, the docking device 1 can more securely hold the native valve loop (e.g., the native mitral valve loop) in the appropriate position and orientation before the THV is implanted and expanded within the docking device 1. Such self - holding of the docking device 1 more effectively prevents unwanted displacement or tilting of the docking device 1 before the artificial valve is fully implanted, thereby improving the performance of the entire implant.

[0057] Figures 6-9 illustrate 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 in this specification) and a THV to the mitral position. These are directed to the mitral position, but similar steps can be used for other valve positions, such as the tricuspid valve position. The docking device can be the docking device 1 or another similar docking device (e.g., other docking devices in this specification) described above with respect to FIGS. 3-5, and the THV is generally a self-expandable, mechanically expandable, or balloon-expandable THV (or combinations thereof) and has a circular or cylindrical valve frame or stent sized to be expanded and retained 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 atrial septum of the heart, advancing the distal end of the delivery catheter 1010 through the guide sheath 1000, and positioning the distal opening of the delivery catheter within the left atrium for delivering the docking device 1. Optionally, the delivery catheter can be similarly advanced and positioned through a biological structure (e.g., the vasculature, cardiac chambers, septum, etc.) without first inserting or using the guide sheath. In an exemplary procedure, the guide sheath 1000 (and / or the delivery catheter 1010) is introduced into the patient's venous system, for example, by percutaneous puncture or a small incision at the patient's groin, and then the guide sheath 1000 (and / or the catheter 1010) is advanced through the patient's vasculature to the left atrium as shown in FIGS. 6 and 7. It should be noted that the illustrated transseptal procedure is merely an example, and alternative procedures and / or access sites can be used instead to deliver the docking device 1 and / or a suitable prosthetic valve to the mitral position or other positions of the heart. However, transatrial or transseptal procedures may be preferred. The reason is that such procedures achieve a more direct access to the left side of the heart compared to, for example, a transapical procedure or other procedures in which access to the mitral valve is through the left ventricle, thereby allowing the physician to avoid direct interference with the chordae tendineae and other ventricular obstacles.

[0059] As shown in FIG. 6, the distal end of the delivery catheter 1010 is positioned directly above the plane of the native 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 placed, for example, near the commissure of the native valve. The delivery catheter can be made operable in multiple dimensions (e.g., more than two dimensions) to allow for a more precise placement. The placement of the distal opening of the delivery catheter defines 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 native mitral valve, whereby the guiding tip 21 of the docking device 1 can be advanced through the native valve commissure into the left ventricle, and at least a portion of the guiding coil / windings (e.g., the ventricular coil) of the lower region 20, as well as at least a portion of the functional coil / windings (e.g., the coil / windings of the central region 10), are deployed into the left ventricle. In one deployment method, first the guiding tip 21 of the docking device 1 is passed through the commissure A3P3 of the native mitral valve, and then more of the docking device 1 is advanced through the commissure A3P3 from the delivery catheter.

[0060] While the docking device 1 is held within the delivery catheter 1010, the docking device 1 can be straightened to more easily manipulate the docking device 1 through the delivery catheter 1010. Thereafter, when the docking device 1 is rotated, pushed, or in some cases advanced from the delivery catheter 1010, the docking device 1 can return to its original coiled or curved shape, and when the docking device 1 is further advanced from the delivery catheter, the guiding tip 21 advances clockwise or counterclockwise (i.e., looking at the valve loop in the blood outflow direction) around various special mechanisms of the mitral biological structure based on the curvature direction of the docking device 1 when the docking device 1 exits the delivery catheter (e.g., goes around). The enlarged guiding coil / winding (e.g., ventricular coil / winding) at the lower region 20 of the docking device 1 facilitates the manipulation of the guiding tip 21 of the docking device 1 around the mitral biological structure in the left ventricle. In the above example, when the guiding tip 21 of the docking device 1 enters the left ventricle through the commissure A3P3 and advances clockwise when looking at the valve loop in the outflow direction (e.g., from the atrium to the ventricle), the docking device 1 can first go around and surround the posterior leaflet tip of the native mitral valve. Alternative methods are also available, for example, by inserting the guiding tip 21 into the commissure A1P1 and then advancing the docking device counterclockwise to first surround the posterior leaflet tip.

[0061] Depending on the situation, initially surrounding the posterior cusp tip of the native mitral valve may be easier than initially surrounding the anterior cusp tip. The reason is that the posterior cusp tip is located closer to the ventricular wall that constitutes a more limited space in which the guiding tip 21 can advance. Thus, the guiding tip 21 of the docking device 1 can use the ventricular wall near the posterior cusp tip as a path or guide for advancing around the posterior cusp tip. Conversely, when attempting to advance the guiding tip 21 of the docking device 1 and initially capture the anterior cusp tip of the native mitral valve, there is no nearby ventricular wall that can facilitate or guide the advancement of the guiding tip 21 in that direction. Thus, depending on the situation, it may be more difficult to appropriately initiate going around the mitral anatomical structure when attempting to manipulate the guiding tip 21 to initially capture the anterior cusp tip rather than the posterior cusp tip.

[0062] So, depending on the procedure, it may still be preferable or necessary to initially surround the anterior cusp tip. Further, in many situations, it may be much easier to curve the distal end of the delivery catheter 1010 in a counterclockwise direction so that the docking device can be delivered. Accordingly, the delivery method of the docking device can be adjusted accordingly. For example, the docking device can comprise a coil / wrap that spirals or rotates in the opposite counterclockwise direction (e.g., see FIG. 10 below), and the delivery catheter 1010 is also wound in a counterclockwise direction. In this way, such a docking device can be advanced into the left ventricle, for example through commissure A3P3, in the counterclockwise direction when viewing the valve loop in the outflow (e.g., from the atrium to the ventricle) direction, 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 particular use or procedure. In one embodiment, most (if not all) of the coils / winds of the lower region 20 and the central region 10 are advanced and positioned within the left ventricle. In one embodiment, all of the coils / winds of the central region 10 are advanced into the left ventricle. In one embodiment, the docking device 1 is advanced to a position where the guiding tip 21 is located behind the anteromedial papillary muscle. This position achieves a more secure fixation of the guiding tip 21 and thus a reliable fixation of the docking device 1. The reason is that the guiding tip 21 is positioned and held between the chordae tendineae and the ventricular wall in that region. On the other hand, after any part of the mitral biological structure is surrounded and / or captured by the guiding tip 21, further advancement of the docking device 1 helps to collect the captured chordae tendineae and / or leaflet tips into the coils of the docking device 1. Both securely positioning the guiding tip 21 and holding the native mitral biological structure by the docking device 1 can help prevent obstruction of the left ventricular outflow tract (e.g., of the aortic valve) prior to implantation of the THV.

[0064] After advancing the desired amount of the docking device 1 into the left ventricle, the remaining portion of the docking device 1 is deployed or released into the left atrium. FIG. 7 shows one method of releasing the atrial portion of the docking device 1 into the left atrium. In FIG. 7, the distal end of the delivery catheter 1010 is rotated backward or retracted, while the 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 the docking device 1 is advanced clockwise through the commissure A3P3, the distal end of the delivery catheter 1010 can then be rotated counterclockwise or retracted to release the atrial portion of the docking device 1. In this way, there is no need to adjust or readjust the ventricular position of the docking device 1 during or after releasing the atrial portion of the docking device 1 from the delivery catheter 1010. Various other methods of releasing the atrial portion of the docking device 1 can also be used. Before releasing the stabilization coil / wind (e.g., atrial coil) from the delivery catheter, the stabilization coil / wind can be held in place and / or retracted / retrieved by a holding device / anchor (e.g., by attaching it to a release / retrieval wire connected by a barb, Velcro® hook, latch, lock, anchor, etc. that can be screwed into the delivery device). After being released, the docking device is not tightly engaged with the native mitral valve (i.e., the docking device is loosely positioned around the native mitral valve leaflet).

[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 create space for another delivery catheter for delivering the THV, or in some embodiments, the delivery catheter 1010 can be adjusted and / or repositioned when delivering an artificial valve through the same catheter 1010. Optionally, the guide sheath 1000 can be left in place, and after the delivery catheter 1010 is removed, an artificial valve or THV delivery catheter can be inserted through the same guide sheath 1000 and advanced within the guide sheath 1000. FIG. 8 shows a cross-sectional view of a portion of a patient's heart before delivering the THV, with the docking device 1 of FIGS. 3-5 positioned at 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 a wall that may lead to obstruction of the left ventricular outflow tract in some cases.

[0066] Furthermore, in at least some procedures, note that the leaflets are not substantially constrained by the docking device between the time the docking device 1 is delivered to the mitral position as described above and the time the artificial valve is implanted within the docking device 1, so that the native mitral valve can continue to operate substantially normally and the patient can remain stable. Thus, the procedure can be performed on a beating heart without the need for a cardiopulmonary device. Additionally, this provides the physician with greater temporal flexibility for implanting the valve prosthesis without the patient being in a position where the hemodynamics are deteriorating or at risk of falling into a position where the hemodynamics deteriorate if an excessive amount of time elapses between implanting the docking device 1 and then implanting the valve thereafter.

[0067] FIG. 9 shows a cross-sectional view of a portion of a heart in which both the docking device 1 and the prosthetic valve 40 (e.g., THV) are ultimately implanted in the mitral position. Generally, the prosthetic valve 40 has an expandable frame structure 41 that houses a plurality of valve leaflets 42. The expandable frame 41 of the prosthetic valve 40 can be balloon-expandable or can be expanded in other ways, e.g., the frame can be self-expanding or mechanically expandable, or can be expandable by combining several methods. The prosthetic valve 40 can be delivered through the same catheter 1010 used to deliver the docking device 1, or generally, can be introduced through a separate catheter while the valve 40 is radially folded so that it can be more easily manipulated through the delivery catheter. In some cases, a guide sheath can be left in place when removing the catheter 1010, and a new prosthetic valve or THV delivery catheter can be advanced through the guide sheath 1000. The prosthetic valve 40 is then advanced from the delivery catheter while still in a folded configuration and placed through the docking device 1, and then the prosthetic valve 40 can be expanded within the docking device 1, whereby the entire assembly is held in place at the mitral position by the radial pressure or tension between the components. The mitral leaflet (or a portion of the mitral leaflet) can be sandwiched between the functional turns of the anchor or docking coil and the frame 41 of the prosthetic valve. After the docking device and the prosthetic valve are successfully deployed / implanted, the remaining delivery instruments can be removed from the patient.

[0068] FIG. 10 shows a perspective view of an exemplary anchor or docking device 1. The docking device 100 in FIG. 10 may have a central region 110, a lower region 120, and an upper region 130 that are the same as or similar to the respective central region 10, lower region 20, and upper region 30 in the aforementioned docking device 1. The docking device 100 can include special mechanisms and characteristics that are the same as or similar to the special mechanisms and characteristics described with respect to the docking device 1, and can be transplanted using the same or similar steps. However, the docking device 100 includes an additional extension 140 disposed substantially between the central region 110 and the upper region 130. In some embodiments, the extension 140 can optionally be disposed, for example, entirely in the central region 110 (e.g., on top of the central region 110) or entirely in the upper region 130. In FIG. 10, the extension 140 is composed 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 140 can be angled with respect to the central axis of the docking device 100, but generally acts as a vertical or axial spacer that vertically or axially separates adjacent connection portions of the docking device 100, thereby forming a vertical or axial gap between the coil portions on each side of the extension 140 (e.g., a gap can be formed between the upper or atrial side and the lower or ventricular side of the docking device 100).

[0069] The extension portion 140 of the docking device 100 is disposed through (e.g., across) or near the native valve loop and is configured to reduce the amount of the docking device 100 that passes through, presses against, or leans on the native valve loop when the docking device 100 is implanted. This can, in some cases, reduce the stress or strain applied to the native mitral valve by the docking device 100. In one configuration, the extension portion 140 is disposed at one of the commissures of the native mitral valve and passes through or intersects this commissure. In this way, the extension portion 140 can separate the upper region 130 from the native mitral valve tip and prevent the upper region 130 from interacting with or engaging the native valve tip from the atrial side. The extension portion 140 also raises the position of the upper region 130, thereby raising or distancing the contact point between the upper region 130 and the atrial wall from the native valve, thereby reducing, for example, the stress on the native valve and the stress around the native valve and achieving a more secure retention of the position of the docking device 100. The extension portion 140 can have a length in the range of 5 mm to 100 mm and is 15 mm in one embodiment.

[0070] The docking device 100 can further include one or more through-holes 150 at or near one or both of the proximal and distal ends of the docking device 100. The through-holes 150 can serve, for example, as stitching holes for attaching a cover layer onto the coil of the docking device 100, and / or as attachment sites for delivery instruments such as pushers, (e.g., holding devices / anchors to hold the docking device and / or to enable pulling in and retrieving the device after the device has been fully or partially deployed from a delivery catheter), or other advancement devices or pull wires / sutures for holding devices. In some embodiments, the width or thickness of the coil of the docking device 100 can also vary along the length of the docking device 100. For example, among other 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 stronger or stiffer, and / or increasing the surface area for stitching or otherwise attaching a cover layer to the coil of the docking device 100. In one embodiment, all or part of the extension 140 can have a thickness that is thinner than the thickness in other regions of the docking device, for example, the extension 140 can be made thinner than, for example, the induction coil / winding or the lower region 120, thinner than the functional coil / winding or the central region 110, and / or thinner than, for example, the stabilization coil / winding or the upper region 130 as shown in FIG. 19.

[0071] In FIG. 10 (and similarly in FIG. 19), the coil of the docking device 100 is shown to be wound in a direction opposite to that of the coil in the docking device 1 described above. Thus, the docking device 100 is configured to be inserted into the native valve loop in a counterclockwise direction when viewing the valve loop in the blood outflow direction (e.g., from the atrium to the ventricle) as shown. This advancement can be made through commissure A3P3, commissure A1P1, or another part of the native mitral valve. Placing the docking device 100 in the counterclockwise direction also allows the distal end of the delivery catheter to be bent in the counterclockwise direction as well, which in many instances is easier than bending the delivery catheter in the clockwise direction. The 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 the various access points (e.g., any of the commissures).

[0072] In most situations and patients, it is necessary to position the docking device high relative to the native mitral valve (e.g., further away within the left atrium). Considering the mitral anatomy, the ultimately combined dock and valve combination needs to be positioned high at the location of the native valve, and in some cases as high as possible, to secure the valve within the clearance zone of the native mitral valve leaflets. Further, in a healthy human heart, the native mitral valve leaflets are generally smoother above the commissure line (e.g., above the portion where the leaflets converge when the mitral valve is closed) and rougher below the commissure line. The smoother region or zone of the native valve leaflets has much more collagen content and is stronger, thereby providing a more secure attachment surface for the artificial valve than the rougher region or zone. Thus, in most cases, the docking device needs to be positioned as high as possible at the location of the native valve during insertion and also needs to have sufficient holding power to secure the artificial valve or THV. For example, the length of the coil in a docking device positioned 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 gets thinner, the length required within the ventricle to provide sufficient holding power gets longer. For example, if the length of the docking device coil is 370 mm, approximately 280 mm (e.g., ±2 mm) is positioned within the ventricle. Approximately 70 mm to 90 mm is positioned within the atrium, and approximately 10 - 15 is used to move the docking device coil away from the plane of the mitral valve on the atrial side of the docking device in the transition length or extension length.

[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 native valve and the generally smaller size of replacement valves, there is an inverse relationship between how high a docking device can be positioned at the mitral location with respect to the coil diameter of the docking device and the holding force that the docking device can impart to the THV to be implanted therein. A docking device with a larger diameter can capture more chordae tendineae and thus has the ability to be deployed higher relative to the native valve, but the holding force on the valve docked to the docking device is weaker. Conversely, a docking device with a smaller diameter can apply a stronger holding force to the valve being docked, but there may not be as many chordae tendineae that can be captured by looping around during placement, whereby the position of the docking device in the native valve loop may be lower. On the other hand, a larger docking device can be modified such that the coil diameter or thickness is increased and / or can be constructed using a material having a higher elastic modulus.

[0074] Figures 11 - 13 illustrate a docking device according to another embodiment of the present invention. The docking device 200 (see FIGS. 12 and 13) includes 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 assume a larger or wider configuration when positioned at the native valve loop and can thus be adjusted by the wire 219 to assume a smaller or narrower configuration in preparation for docking an artificial valve thereafter.

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

[0076] When applying tension to the docking device 200 or operating the docking device 200, laser cut patterning can also be modified or changed along the length of the tube 210 such that each cut has a different size, shape, and position on the sheet or tube so that different shapes and curvatures are obtained in the docking device 200 respectively. For example, as can be seen by looking at FIG. 11, the left end portion of the sheet or tube includes other cuts 216 that are larger than the cuts 211 seen in the central and right portions of the sheet or tube (as shown). The left end portion of the tube 210 can have such an enlarged laser cut pattern so as to make the distal tip of the docking device 200 more movable or more flexible, as will be described in more detail below.

[0077] Further, the laser cut sheet or tube can include one or more distal wire lock special mechanisms, such as cut 217, at or near the distal end or left end of the sheet or tube as shown, and / or one or more proximal wire lock special mechanisms, such as cut 218, at or near the proximal end or right end of the sheet or tube as shown. One or both of the distal wire lock special mechanism 217 or the proximal wire lock element can be used to attach the locking wire 219 shown in FIG. 11A to the distal or proximal end of the tube 210, and then tension can be applied through the tube 210 to the locking wire 219 to lock it to the opposite end of the tube 210 to obtain the desired operating shape of the docking device 200. By arranging the laser cut pattern along a large portion or the entire length of the tube 210, when the locking wire 219 is attached to one end of the tube 210 and then actuated to lock to the other end of the tube 210, the tube 210 is forced into the desired final coiled form or shape by the configuration of cuts 211 and 216. The tension in the tension wire has the ability to control the radially outward and inward forces applied onto the docking device 200 and the radially outward and inward forces applied by the docking device 200 to other special mechanisms, such as the replacement 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 placed into a laser cut hypo tube, or the locking wire can be placed into a non-laser cut tube. The locking wire can be a suture, tether, wire, strip, etc., and can be made of various materials such as metal, steel, NiTi, polymer, fiber, Dyneema, other biocompatible materials, etc.

[0078] In some embodiments, such as embodiments that assemble the docking device 200 using a shape memory material such as NiTi, the tube 210 can be disposed around a mandrel that defines the desired coil diameter during manufacture and the shape setting at that particular diameter. The shape setting diameter can be larger than the desired final diameter of the docking device 200 in some embodiments, such that the tube 210 assumes this larger shape setting diameter when extruded from the delivery catheter and before actuating the locking wire or tension wire. During this time, the larger diameter of the docking device 200 can help to more easily manipulate and rotate the docking device 200 around the biostructure shape of the native valve.

[0079] Further, in some embodiments, the distal tip 222 of the tube 210 can be shaped differently, such that instead of following the same coil shape as the rest of the docking device 200, the distal tip 222 deflects or articulates slightly radially outward compared to the other parts of the docking device 200, as can be seen by looking at FIG. 12, and further aids in rotating around the mitral biostructure or other valve biostructure. In addition to or instead of the different shape settings as described above, the distal end 222 of the tube 210 can include different cuts 216 to make the distal end 222 more flexible or more movable, and the cuts 216 can help to manipulate the distal end 222 of the docking device 200 around the biostructure shape.

[0080] The docking device 200 is operated around the mitral biostructure or other biostructure shapes, and after reaching the desired position relative to the native valve, tension is applied to the locking wire or it is actuated in another way to reduce the size of the docking device (e.g., reduce the diameter of the coil winding) so that a more secure or reliable docking of the prosthetic replacement valve 40 can be achieved. On the other hand, in some embodiments where the distal tip 222 of the docking device 200 is shaped to bend outward, the tension in the locking wire can, in some cases, further pull or draw the distal tip 222 inward, whereby the distal tip 222 more closely conforms in shape to the remainder of the docking device 200 and effectively contributes to the docking of the replacement valve 40.

[0081] Thereafter, the replacement valve 40 can be placed and expanded within the docking device 200. FIG. 13 is an example of the docking device 200 after being actuated by the locking wire and after expanding the replacement valve 40 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, and a stronger and more secure hold is achieved between these members. As can be seen by further looking at FIG. 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 produce a flaring effect at the end of the frame of the valve 40, whereby a much more secure hold is achieved 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 can be made from a shape memory material other than NiTi or can include a shape memory material other than NiTi, or in some embodiments, can be made from a non-shape memory material such as stainless steel, other biocompatible materials, and / or combinations thereof. Further, although the docking device 200 was described above as being used at the mitral valve, in other applications, a similar or slightly modified docking device can be used to dock a replacement valve at other native valve sites, such as the tricuspid valve, pulmonary valve, or aortic valve.

[0083] The above-described docking device 200, and similar devices using tension wires or locking wires, can provide several advantages over other docking devices, such as devices that do not use locking wires. For example, the locking wire provides the user with the ability to control the amount of radially outward and inward forces applied by generating and adjusting tension in the locking wire, without compromising the desired profile of the docking device, either on or by the docking device, or the ability to deliver the docking device via a catheter or minimally invasive technique. FIG. 11A shows a tension wire 219 that is held below or looped around a tooth 218 and then pulled through an opening 217 and crimped at the opening 217 to set the shape of the docking device. Further, the docking device is made more flexible by laser-cutting the tube, allowing the docking device to be introduced through a catheter that may have a relatively small bend radius at some locations.

[0084] In embodiments where a shape memory material is used, the docking device can be shaped to include a coil / winding having a larger diameter to allow the coil to more easily wrap around the biological structure special mechanism during sending of the docking device and before applying tension to the locking wire. Further, the distal tip of the docking device can be further shaped to slightly bend or deflect outward to assist in wrapping around a much greater portion of the biological structure shape while advancing and positioning the docking device. Further, in some embodiments, for example, more material is removed to form a larger cut, making the distal portion of the docking device much more flexible, thereby further modifying the distal end of the docking device so that the tip can be more easily actuated and manipulated to more effectively operate around different cardiovascular biological structures and wrap around the cardiovascular biological structures. The pattern can be laser cut to make the force in one region weaker than the force in another region. The tube can be made oval, i.e., the cross-sectional area of the tube can be made oval, whereby a force can be applied to bend the tube in a desired direction. Tension wires can also be attached to both the proximal and distal ends of the tube to create tension. Exemplary cut patterns are illustrated, but other cut patterns are possible.

[0085] One or more of the docking devices described herein (e.g., docking devices 1, 100, 200, 300, 400, 500, 600, and 1100 herein) can be further incorporated with or additional to various mechanisms to strengthen the holding force between the docking device and the replacement valve expanded within the docking device. Generally, a coiled docking device or a coil-shaped docking device has two open ends or free ends after implantation. When a THV or other replacement valve is expanded within the coil, the coil may be partially unwound, and the diameter of the coil increases due to the outward pressure applied by the valve expanding on the coil, and the holding force applied by the coil to the valve is reduced. Therefore, a mechanism or other special mechanism for preventing or reducing the unwinding of the coil when the replacement valve is expanded within the coil can be incorporated into the docking device, thereby strengthening the radial force and the holding force between the docking device and the valve. Such a mechanism can be incorporated without, for example, increasing the thickness of the coil or reducing the diameter of the inner space formed by the coil, either of which would adversely affect the performance of the docking device or the ease of delivering the docking device, instead of modifying the size and shape of the docking device. For example, making the coil of the docking device itself thicker increases the rigidity of the coil due to the increased thickness, making it more difficult to pass the docking device through a delivery catheter. On the other hand, overly reducing the diameter of the inner space formed by the coil may prevent the expandable valve from fully expanding due to the narrowing of the space.

[0086] A first alternative modification for ensuring sufficient holding force between a docking device and a valve expanded within the docking device is shown in FIG. 14. The docking device 300 in FIG. 14 includes a main coil 310 (which may be similar in size and shape to one of the docking devices described above), and an anchor 320 extending from two free ends of the coil 310. The anchor 320 is configured to have a size or shape such that, for example, when a replacement valve is expanded within the docking device 300, the anchor itself is embedded in the surrounding tissue (e.g., the atrial wall and / or the ventricular wall), or is configured in other ways. The anchor 320 can be provided with barbs to promote internal growth after the anchor 320 is embedded in the heart wall or other tissue. The anchor can be of any of a number of different shapes and sizes. The anchor can extend from an end or any region near an end. In some cases, the anchor or barbs can also be arranged at various positions along the length and outer surface of the docking device.

[0087] During operation, when the docking device 300 is deployed in the mitral biological structure, after the docking device 300 is disposed through the mitral valve, one end of the docking device 300 is disposed in the left atrium, while the other end of the docking device 300 is disposed in the left ventricle. The shape and size of the coil 310 of the docking device 300 can be selected and optimized such that when the docking device 300 is advanced to a desired position, the ends of the coil 310 respectively abut securely against the atrial wall and the ventricular wall. Thus, the anchors 320 at the ends of the coil 310 can be fixed within their respective heart walls themselves. When the replacement valve is expanded within the coil 310, the free ends of the coil 310 are held in place by the anchors 320 stored within the heart wall. Since the free ends of the coil 310 cannot move when the replacement valve is expanded within the docking device 300, the coil 310 is prevented from being wound back, thereby increasing the radial force applied between the docking device 300 and the expanded valve and improving the holding force between these components.

[0088] FIG. 15 shows a schematic view of a portion of another modified docking device for improving the holding force between the docking device and the replacement valve. A portion of three turns of the docking device 400 is shown in FIG. 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 a variety of other biocompatible materials, or a coil / core that includes one or more of a variety of other biocompatible materials. The docking device 400 further includes a coating 420 that covers the coil / core 410. The coating 420 can be made of or include a high-friction material, such that when an expandable valve within the docking device 400 is expanded, the amount of friction generated between the valve and the coating 420 is increased, maintaining the shape of the docking device 400 and preventing or suppressing / opposing the 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 tip and / or artificial valve and help maintain the relative positions of the docking device, valve tip, and / or artificial valve.

[0089] The membrane 420 is made of one or more high-friction materials disposed on the coil wire 410. In one embodiment, the membrane 420 is made of or includes PET braided over an ePTFE tube, and the ePTFE tube serves as a core for the membrane 420. The ePTFE tube core is porous and constitutes a cushioned, packed layer for the struts or other parts of the expandable valve frame, improving the engagement between the valve and the docking device 400. On the other hand, the PET layer generates additional friction against the natural valve leaflets when the artificial valve is expanded, and the struts or other parts of the valve frame apply an outward pressure to the docking device 400. These special mechanisms work together to strengthen the radial force between the docking device 400 and the natural valve leaflets and / or the artificial valve, thereby also strengthening the holding force and preventing the docking device 400 from being wound back.

[0090] In other embodiments, the coating 420 can be made of one or more other high-friction materials that similarly cover the coil 410. The material selected as the material for making the coating 420 can also promote rapid internal growth of the tissue. Further, 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 strengthen the frictional force between the docking device and the valve, thereby further preventing or reducing the unwinding of the docking device. With the friction generated by the coating, the coefficient of friction can be made greater than 1. The coating can be made of ePTFE, can be a tube covering the coil, and can be smoothed or made porous (or braided or have other structural special mechanisms that increase the accessible surface area similar to pores) to promote internal growth of the tissue. The coating can also have PET braided on the ePTFE tube when the ePTFE tube is smooth. The outermost surface of the coating or the outermost surface braided on the coating can be any biocompatible material that generates friction, such as a biocompatible metal, silicone tubing, or PET. The pore size in the coating can range from 30 microns to 100 microns. In embodiments where there is a PET coating on the ePTFE, the PET layer is only attached to the ePTFE coating and not directly to the coil of the docking device. 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 an X-ray radiopaque marker can be placed outside the ePTFE tube coating or the PET blade and caulked against the material to hold the material in place relative to the coil.

[0091] On the one hand, in some embodiments, the docking device 400 can also include an anchor similar to the above-described anchor 320 to further enhance the holding force. However, 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 in-tissue growth can also act to reduce the load on the composite valve and the dock assembly.

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

[0093] Figures 16 and 16A schematically show a portion of another modified docking device that improves the holding force between the docking device and the replacement valve. As shown in the cross-sectional view of Figure 16A, the valve tip tissue 42 is wavy so as to conform to a variable cross-section between a region of the coil 510 that includes the friction element 520 and a region of the coil 510 that does not include the friction element. When the valve tip tissue 42 is wavy in this way, 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 along the length of the coil 510. The friction element 520 can be made of 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 disposed on the coil 510. In some embodiments, the coating 420 itself can be regarded as a friction element or configured to form one or more of the friction elements 520. In some embodiments, the friction element 520 is added in addition to adding 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 on the main coil 510 is schematically shown in Figure 17.

[0094] When an expandable valve within docking device 500 is expanded, friction is created that prevents or inhibits the unwinding of coil 510 of docking device 500 and / or resists unwinding between the valve's frame and friction element 520 and / or between the valve's frame and the natural valve tip and the docking device. For example, friction element 520 may engage the cells defined by the expandable valve's frame or extend into the cells in some other way, and / or push the valve tip tissue into the cells of the expandable valve. Further, when the valve is expanded within docking device 500, each of friction elements 520 may engage adjacent turns of docking device 500 above and / or below friction element 520, and / or engage one or more other friction elements 520 on adjacent turns of docking device 500. Any or all of these such engagements cause docking device 500 to inhibit or resist unwinding, thereby increasing the holding force between docking device 500 and the expanded valve.

[0095] FIG. 18 schematically shows a portion of three turns of yet another modified docking device 600 that helps improve the holding force between the docking device and the replacement valve. Docking device 600 includes a coil 610 modified by one or more interlocking keyhole and key patterns spaced along the length of coil 610. The keyhole and key pattern may be simple, for example, as schematically shown in FIG. 18, rectangular grooves or notches 618 and complementary rectangular protrusions 622, or may be made in different shapes and / or more complex patterns or include different shapes and / or more complex patterns in other embodiments. Further, in various embodiments, all of grooves 618 and protrusions 622 may be arranged in the same axial direction or in different axial directions. The keyhole and key pattern or other friction elements may be disposed on the functional turns of the docking device.

[0096] When an expandable valve within docking device 600 is expanded, the keyhole and key mechanism depend on adjacent turns of coil 610 that abut each other and adjacent turns of coil 610 located above and / or below each turn when one or more of protrusions 622 engage corresponding grooves 618. The interlocking of grooves 618 and protrusions 622 prevents relative movement between the respective special mechanisms and thus also prevents the coil 610 of docking device 600 from being physically wound back. Thus, this configuration also serves to strengthen the radial force and final holding force between docking device 600 and a replacement valve that is expanded within docking device 600.

[0097] FIG. 19 shows a perspective view of an exemplary anchor or docking device. The docking device 1100 in FIG. 19 can have the same or a similar structure as the docking device 100 in FIG. 10 above and can include any of the special mechanisms and characteristics described with respect to docking device 100. The docking device 1100 can 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 can form a coil diameter larger than that of the central region 1110, and the extension region 1140 can, as also described above, vertically separate the upper region 1130 from the central region 1110. The docking device 1100 is also arranged or wound such that advancement of the docking device 1100 into the left ventricle of the heart can be performed counterclockwise when viewing the valve loop in the outflow direction (e.g., from the atrium to the ventricle). Other embodiments can alternatively facilitate clockwise advancement and placement of the docking device.

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

[0099] On the other hand, the lower region 1120 of the docking device 1100 functions as an induction coil / winding (e.g., a ventricular encircling winding). The lower region 1120 includes the distal tip of the docking device 1100 and extends radially outward from the central winding 1110 to capture some or all of the natural valve leaflets and chordae tendineae and / or other mitral valve biological structures when the docking device 1100 is advanced into the left atrium. A natural mitral valve showing mitral regurgitation generally has an A2P2 distance of 35 mm and a distance from commissure to commissure of 45 mm. Thus, when using 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 biological structure. Accordingly, the lower region 1120 is formed to have a larger size or profile compared to the central winding 1110 so as to more easily guide the docking device 1100 initially around both natural valve leaflets. 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), whereby the distal tip extends approximately that distance from the outlet of the delivery catheter while the docking device 1100 is being delivered.

[0100] The upper region 1130 of the docking device 1100 serves as a magnetizing coil / winding (e.g., an atrial coil / winding) that provides a self - holding mechanism to the docking device 1100 during the transition phase from when the docking device 1100 is deployed at the native valve until the THV is delivered. The left atrium generally extends outward from the mitral valve loop and forms a funnel - shaped structure that extends away from the valve loop. As the diameter of the upper region 1130, a diameter is selected that allows the upper region 1130 to fit at a generally desired height within the left atrium and that prevents the upper region 1130 from sliding or falling further towards the native mitral valve loop after the desired position is achieved. In one example, the upper region 1130 is formed to have a diameter such as about 53 mm, with a diameter ranging from 40 to 60 mm.

[0101] Furthermore, as the shape and position of the upper region 1130, a shape and position are selected such that after the THV is deployed within the docking device 1100, the pressure exerted by the upper region 1130 on the portion of the atrial wall adjacent to the aortic wall is minimized or eliminated. FIG. 20 is a schematic top view of a portion of the heart, approximately showing the left atrium 1800 and showing the mitral valve 1810 disposed at a location in its central region. Furthermore, the approximate position of the aorta 1840 is also schematically shown. On the other hand, the docking device 1100 is being delivered to the native mitral valve 1810 at the commissure A3P3 1820. Here, it should be noted that the upper region 1130 of the docking device 1100 is disposed at a position away from the wall 1830 of the left atrium 1800 adjacent to the aorta 1840. Furthermore, when the THV is expanded within the docking device, the central region 1110 of the docking device 1100 tends to expand slightly and unwind, thereby further pulling the upper region 1130 away from the atrial wall 1830 (counter - clockwise and downward as shown in FIG. 20). Further details regarding the placement of the docking device 1100 relative to the mitral valve 1810 will be described below with further reference to FIG. 20.

[0102] The extension region 1140 provides vertical extension and separation between the central region 1110 and the upper region 1130 of the docking device 1100. Thus, in some embodiments, the extension region 1140 of the docking device 1100 (and the extension region 140 of the docking device 100) may be referred to as a lift coil. The position where the docking device 1100 intersects the mitral plane is important for maintaining the integrity of the native valve anatomy, specifically the leaflet tips and commissures, to serve as an appropriate docking site for the final implantation of the THV. In a docking device without such an extension or lift region 1140, more of the docking device is positioned on or in contact with the mitral plane, pinching the native leaflet tips, and as the docking device moves relative to the native leaflet tips or as the docking device rubs against the native leaflet tips, in some cases, the native leaflet tips may be damaged from the atrial side. With the extension region 1140, the portion of the docking device 1100 disposed within the left atrium can rise and separate from the mitral plane.

[0103] Furthermore, the extension region 1140 of the docking device 1100 can also have a smaller diameter cross-section. In the illustrated embodiment, the wire core of other regions of the docking device 1100 can have a diameter of, for example, 0.825 mm, while the core of the extension region 1140 can have a diameter of 0.6 mm. In another embodiment, the wire core of other regions of the docking device has a cross-sectional diameter of 0.85 mm, and the extension region has a cross-sectional diameter of 0.6 mm. When the cross-sectional diameter of other regions of the docking device coil is 0.825 mm or more, or the cross-sectional diameter is 0.85 mm or more, the extension region 1140 has a cross-sectional diameter of 0.4 - 0.8 mm. The thickness can also be selected based on the ratio to each other. The extension region can have a cross-sectional diameter that is 50% - 75% of the cross-sectional diameter of the remaining portion of the wire. The extension region 1140 having a smaller cross-section can make the angle at which the extension region 1140 rises from the mitral plane more acute. The radius of curvature and wire cross-section of the extension region 1140 can further be selected such that, for example, sufficient connection points are provided between the central region 1110 and the upper region 1130 of the docking device 1100, and / or to enable the extension region 1140 to be more easily deployed and recovered with a weaker force while sending the docking device. The reason is that a thinner wire core is easier to straighten or bend. Further, in embodiments where shape memory such as NiTi is used for the wire core, it is necessary to select the thicknesses of both the extension region 1140 and the remaining portion of the docking device 1100 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 by one or more additional materials. These cover or layer materials can be attached in a variety of ways, including, for example, adhesion, melting, molding, etc. around the core, or stitching, tying, or bonding the cover / layer to the wire core by other methods. Referring briefly to FIG. 22, a cross-section of the distal portion of the docking device 1100 includes a wire core 1160 and a 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 can be compressed more easily than the wire core 1160, such that when the THV is expanded within the docking device 1100, the wire frame and / or struts of the THV can be partially embedded in or otherwise secured to the cover layer 1170, providing additional stability. The more compressible material also makes it possible to reduce the trauma of pinching or compressing the native valve leaflets and other biological structures between the docking device 1100 and the THV, reducing wear and / or damage to the native biological structures. In the case of ePTFE, the material forms a layer that is neither water permeable nor blood permeable, but allows ethylene oxide gas to pass through or penetrate, thereby more easily sterilizing the underlying wire core 1160. On the other hand, the ePTFE cover layer 1170 is not blood permeable, but can be formed, for example, with a pore size of 30 microns to facilitate the adhesion of blood cells inside and on the outer surface of the cover layer 1170, for example, to promote the ingrowth of tissue after implantation. Additionally, ePTFE is also a material with very low friction. The docking device 1100 having an ePTFE cover layer 1170 achieves stability and promotes ingrowth.

[0105] The low-friction ePTFE cover layer 1170 can assist in the interaction between the end of the docking device 1100 and the native heart biological structure, but 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. Thus, as can be seen in FIG. 19, in the central region 1110 of the docking device 1100, in addition to the ePTFE layer 1170 (which may be the same or similar to the coating 420 and / or the friction element 520 in some cases), an additional coating 1180 can be added. FIG. 19A shows a cross-sectional view of each layer. The coating 1180 (shown as a braided layer) or other high-friction layer creates additional friction between the coils adjacent to each other when the THV is expanded within the docking device 1100 and against the native valve leaflets and / or the THV. The friction that occurs at the interface between the coils and between the inner surface of the central region 1110 of the docking device 1100, the native mitral valve leaflets, and / or the outer surface of the THV forms a more secure locking mechanism for firmly attaching the THV and the docking device 1100 to the native valve. The functional coil / winding or central region 1110 of the docking device 1100, i.e., the region of the docking device that interacts with the THV, is generally only the region where a high-friction coating / layer is desired. As seen in FIG. 19, the braided layer or high-friction coating / layer 1180 does not extend into the lower region 1120 or the extension region 1140, such that those regions of the docking device 1100, along with the upper region 1130, remain low-friction, and thus, a less traumatic interaction with the native valve and other heart biological structures is promoted. By any combination of the high-friction coating / layer 1180 and the high-friction element or other special mechanisms described herein and shown in FIGS. 15 - 18, additional friction elements, and thus an improvement in the holding force between the docking device and the replacement valve, can also be added to the device.

[0106] Figure 20 is a top view of a possible placement of the docking device 1100 within the native mitral valve 1810 before expanding the THV therein. 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 a desired amount of the docking device 1100 (e.g., most of the lower region 1120 and the central region 1110) has been advanced into the left ventricle, the remaining windings of the docking device 1100, e.g., any remaining portion (if any) of the central region 1110, the extension region 1140 (or a portion thereof), and the upper region 1130 are then released from the delivery catheter, e.g., by clockwise or counterclockwise rotation of the delivery catheter, thereby extracting or otherwise releasing these portions of the docking device 1100, while the positions of the central region 1110 and the lower region 1120 of the docking device 1100 remain fixed or remain substantially in a predetermined position relative to the surrounding biological structure. In Figure 20, each part of the device 1100 below the native valve is shown in dotted lines.

[0107] It may be very important to correctly position the docking device 1100. In one embodiment, the docking device 1100 needs to be positioned relative to the native mitral valve 1810 such that a desired portion of the docking device 1100 extends through the native valve 1810 at or near the location of the commissure A3P3 and contacts the atrial side of the native valve leaflet. For example, as can be seen by looking at Figure 19, the proximal portion of the central region 1110 of the docking device 1100 extends between the proximal end of the sheath or braid layer 1180 and the extension region 1140, and 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 native valve leaflet. On the other hand, the portion of the docking device 1100 passing through the mitral valve can be, for example, the portion of the central region 1110 that is exposed immediately adjacent to the end of the sheath or braid layer 1180, or can include some of the proximal end of the sheath or braid layer 1180.

[0108] The advancement of the lower coil or ventricular coil of the docking device 1100 into the left ventricle needs to 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. FIG. 21 is a top view of a modified embodiment of the docking device 1100, with two marker bands 1182, 1184 added to the docking device 1100. The marker bands 1182, 1184 are arranged side by side. The marker bands and / or visualization special mechanisms can be arranged at various positions. In FIG. 20, the first marker band 1182 is arranged at the proximal end of the high friction layer 1180, while the second marker band 1184 is arranged at a position 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 identifying the position of the proximal end of the high friction layer 1180 with respect to both the delivery catheter and the natural mitral biological structure. 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 (for example, when the marker bands reach the desired posture close to the commissure A3P3), and when to start the release or extraction of the remaining proximal part 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 methods, but the present invention is not limited thereto. In some embodiments, instead of the above, one or more marker bands are arranged on the low friction layer 1170 close to the end of the braided layer 1180 or at other parts of the docking device 1100 based on the user's preference. In other embodiments, fewer or more marker bands can be used. The braided layer 1180 can extend across the part of the docking device coil that engages the replacement heart valve.

[0109] Any of the docking devices of this specification can be further modified, for example, to facilitate or assist in advancing the docking device to an appropriate position relative to the native valve. For example, it can also be modified to help prevent the native valve and other native heart tissues from being damaged by the docking device during implantation and placement of the docking device. In the mitral application, when introducing or rotating the leading or distal tip of the coiled docking device as described above to a predetermined position within the left ventricle, the distal tip can be sized and shaped to be more easily manipulated around the chordae tendineae and to rotate around the chordae tendineae, and / or configured in other ways as such. On the other hand, the distal tip needs to be non-invasive, so that the native structure is not damaged when advancing the distal tip around and / or through the mitral valve native structure or other valve native structures.

[0110] In one aspect, in some embodiments, the proximal end of the docking device is attached to a pusher within a 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 replaced with one another. The pusher, while attached to the docking device, can assist in pushing, pulling, or retrieving the docking device relative to the delivery catheter and can enable repositioning of the docking device at any stage throughout the delivery process. The methods described herein can include various steps related to the retrieval and repositioning of the docking device, such as pulling in or pulling on a push rod / suture / tether or other special mechanism to draw the docking device back into the delivery catheter, and then repositioning and reimplanting the docking device at a different location / orientation or site. In a docking device having a cover layer, such as a cloth layer covering the skeleton or coil skeleton of the docking device, adjusting the docking device by the pusher can apply frictional forces to the cover layer, particularly at portions located at the proximal and distal ends of the docking device, for example, by the heart anatomy and / or the pusher / push rod, the pusher device itself. Thus, both the structure at the end of the coil of the docking device and the connection technique (e.g., adhesion or suturing technique) for connecting the cloth layer to the coil can be important in handling such frictional forces and preventing the cloth layer from tearing away from the coil or the end of the coil.

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

[0112] Referring to FIGS. 19 and 22, the docking device 1100 can optionally further include fixation holes 1164 near each of the proximal and distal tips. The fixation holes 1164 can be used to further secure the cover layer 1170 to the wire core 1160 via, for example, suture or other tie-downs. This fixation means and / or similar fixation 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. Optionally, for the cover layer 1170, attachment, melting, molding, etc. around the core can be performed without suturing.

[0113] In some embodiments, the distal tip of the docking device 1100 can be slightly tapered radially inwardly, for example, in a circular tangential direction formed by the coil in the central region 1110. Similarly, the stabilization coil / winding or the upper region 1130 of the docking device 1100 can be slightly tapered radially inwardly, for example, in a circular tangential direction formed by the coil in the central region 1110 (or having a tangential portion), and can also be directed, for example, slightly upward and away from the other coils of the docking device 1100 towards the atrial ceiling. The upper region 1130 of the docking device 1100 can be configured as described above as a precaution in cases where, for example, the docking device 1100 is not placed in the desired position described above and slides towards the left ventricle, the upper region 1130 may come into contact with the mitral plane in some cases, or the docking device 1100 is implanted in a heart having an abnormal biological structure.

[0114] Regarding 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 can further include a second hole or bore 1162. As shown in FIG. 22A, the hole or bore 1162 can loop a holding device such as a long release / retrieval wire or suture 1163 to connect or attach the docking device 1100 to the distal end of a pusher of the delivery catheter or other special mechanism. The hole 1162 can be rounded and smoothed to prevent unintentional cutting of the wire / suture. The wire / suture enables the docking device 1100 to be securely attached to the delivery catheter and also enables the docking device 1100 to be pulled and retrieved when the retraction, partial retrieval, or full retrieval of the position of the docking device 1100 is desired. FIG. 22C shows a detailed view of the release wire / suture 1163 looped through the bore 1162 of the docking device 1100, where the exterior of the delivery catheter 1010 is cut away. The pusher device 1165 is configured as a pusher tube having a lumen extending, for example, end to end therein. The wire / suture in this embodiment extends through a longitudinal hole penetrating the pusher device / tube 1165 held within the delivery catheter 1010. On the other hand, after the desired placement of the docking device 1100 is achieved, the physician or other user can simply cut the proximal portion of the wire / suture, pull the wire / suture in the proximal direction, and 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 looped 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 fixing the two ends to the handle or hub).Upon cutting, a portion of the wire / suture can be left attached to the handle or hub (or optionally held by a healthcare provider), such that the wire / suture can be pulled proximally until the cut end exits the bore 1162 and releases the delivery device. FIG. 22B shows another embodiment where 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 or both of the distal and proximal ends of any of the docking devices described herein, thereby making the docking device more robust. FIG. 23 shows exemplary ends of a core or coil skeleton of a docking device according to another embodiment of the invention that can be used at the distal and / or proximal ends of the device. The ends of the coil / core 710 can be made of or include nitinol, another shape memory metal or material, and / or a non-shape memory material. The illustrated ends of the coil / core 710 are substantially flat or have a rectangular cross-section and include a tip 712 (e.g., a ring-shaped tip or other shaped tip). The illustrated rectangular cross-section can be formed only at the ends of the coil 710 in such a manner or can extend along the length of the coil 710, while in other embodiments, the entire coil 710, including the distal and / or proximal end regions, can have a more rounded or other shaped cross-section. The ring-shaped tip 712 has a widened or expanded width compared to other portions 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 end 718 opposite the tip 712 can be formed as a rounded or tapered transition between the tip 712 and the region adjacent the tip 712 of the coil 710. The coil 710 includes one or more cover attachment holes 720 near the tip 712, which can further assist in attaching a cover layer disposed on and 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 a woven PET cloth, or can be made of or include any other cloth or other biocompatible material. Such a cover layer can be used to cover most 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 that case, for example, the cover layer can be connected to the ring-shaped tip 712 via a suture that passes through the through hole 714, advances over the arcuate free end region 716, and covers the arcuate free end region 716. The suture serves to fix the cover layer to the skeleton / core 710 and also serves to soften the edge of the ring-shaped tip 712. Additional sutures can be passed through one or more cover fixing holes 720 near the tip 712 to further fix the cover layer to the skeleton / core 710 of the docking device.

[0117] Figure 24 shows the end of the skeleton or core of a docking device that can be used at the proximal end and / or distal end of any of the docking devices described herein. The end of the coil / core 810 can be made of or include nitinol, another shape memory metal or material, and / or a non-shape memory material. The end of the coil / core 810 has a distal ball tip 812. The ball tip 812 can be preformed with the rest of the skeleton / core 810, or can be a separate ball-shaped or short rod-shaped attachment with a rounded end that is welded or otherwise attached to the end of the coil / core 810. On the other hand, a small gap 814 is formed or left between the ball tip 812 and the rest of the coil / core 810. The gap 814 can be about 0.6 mm, or any other size sufficient to facilitate the passage and / or crossing of one or more suture threads for securing 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 layer / coating can be made of or include, for example, an ePTFE core tube covered with a woven PET cloth, or can be made of or include any other cloth or other biocompatible material. In one attachment method, such a cover layer / coating covers the body of the coil skeleton 810, covers the gap 814, covers up to or slightly onto the ball tip 812, while exposing the free end of the ball tip 812. The cover layer / coating is then connected to the end of the coil 810, for example, via suture threads passing through the gap 814. In a second attachment method, the entire ball tip 812 is wrapped and completely covered with a cover layer, and then suture threads are passed through and / or crossed with the gap 814 to secure the entire cover layer onto the end of the ball tip 812.

[0119] The tips 712, 812, as illustrated and described with respect to FIGS. 23 and 24, comprise small rounded - ended noses that can help enable easier and more convenient operation of their respective docking devices within the left ventricle of the heart. Further, since each of the tips 712, 812 is curved or rounded, the tips 712, 812 form an end portion with a soft edge. The shape and structure at the ends of the respective coil skeletons 710, 810, the type, structure, and configuration of the cover layer, and the suturing technique for attaching the cover layer to the skeletons 710, 810 also enable a tight connection between the tips 712, 812 and their respective cover layers without using a suture or other adhesive. Further, this tip configuration prevents sharp edges from being exposed and, as a result of any frictional forces applied to the cover layer of the docking device during or after sending the docking device, prevents the surface of the skeletons 710, 810 from cutting and / or protruding from the cover layer.

[0120] As described above, in some embodiments, the docking device can be attached to a pusher that can more easily facilitate pushing and pulling to send and readjust the docking device. FIG. 25 shows an exemplary end of the coil skeleton / core 910 of a docking device 900 that 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 FIG. 26 shows an end of the docking device 900 that includes a cover layer 920 on the coil skeleton / core 910 and suture threads 930 for attaching the cover layer 920 to the coil skeleton / core 910.

[0121] Referring first to FIG. 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 that is substantially flat or has a rectangular cross-section. The illustrated rectangular cross-section can form the end region of the coil / core 910 in such a way or extend along the length of the coil / core 910, while in other embodiments, the entire coil / core 910 including the end region can have a more rounded cross-section or a cross-section of another shape. The oval slit hole or elongated slit hole 912 extends through the end region of the coil / core 910, and two sides 914, 916 of the coil / core 910 extend along each side of the slit hole 912 to connect the proximal free end 918 of the coil / core 910 to the remainder of the coil / core 910. The slit hole 912 has a width sufficient for a needle and / or one or more sutures 930 to pass through or cross.

[0122] As shown in FIG. 26, the membrane / cover layer 920 can be, for example, a membrane, a cloth layer, or another layer having the same or a similar configuration as described above with respect to previous embodiments of the docking device. The membrane / cover layer 920 wraps around the coil / core 910 and is secured to the coil / core 910 by a suture 930 that extends along and passes through the slit hole 912 or is otherwise fixed to the coil / core 910. The suture 930 can cross the slit hole 912 in a figure-eight pattern as shown in FIG. 26, and the suture 930 passes through the slit hole 912 at least twice and wraps 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 suture 930 passes through the slit hole 912 at least four times and wraps around the sides 914, 916 on each side of the slit hole 912 at least twice each. The suture 930 is disposed at or moved proximal to the proximal portion of the slit hole 912 near the free end 918 of the coil skeleton / core 910, such that the distal end of the slit hole 912 remains exposed and accessible to the user, and the pull wire 940 (e.g., release / retrieval suture) of the pusher of the delivery catheter passes through or crosses it, thereby remaining open wide enough to establish 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 to advance the docking device 900 from the delivery catheter. On the other hand, for example, when it is desirable to retract or draw in the docking device 900 to reposition the docking device 900 at the implantation site, the pull wire 940 can be pulled proximally to draw in the docking device 900 in the proximal direction as well. Similar steps can be used for other docking devices herein. When the pull wire 940 is retracted, the pull wire abuts against the suture 930 extending through the slit hole 912, and the slit hole 912 forms an intersecting suture region that serves to form a buffer loading region against which the pull wire 940 can abut by means of an "8" - shaped suture. Thus, the suture 930 serves to secure and attach the cover layer 920 to the coil skeleton / core 910, and also hides or covers the sharp edges of the slit hole 912 to prevent the pull wire 940 from being damaged or broken by the docking device 900 during the retrieval of the docking device 900 or when pulling for other purposes, and conversely, to prevent the docking device 900 from being damaged by the pull wire 940.

[0124] Similar to the end configurations described with respect to FIGS. 23 and 24, each of the shape and structure at 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., stitching technique) for attaching the coating / cover layer 920 to the coil skeleton / core 910 contributes to closely connecting the end of the coil 910 and the coating / cover layer 920 and can be achieved whether or not an adhesive such as glue or other adhesive is used (e.g., the stitching technique does not require these). Further, this tip structure and configuration prevents sharp edges from being exposed and prevents the surface of the coil skeleton / core 910 from cutting 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 sending the docking device.

[0125] In various other embodiments, any or all of the various special mechanisms different from the above-described embodiments can be combined or modified based on the requirements of each individual patient. For example, depending on the particular characteristics or requirements of a particular patient, 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.

[0126] Regarding the embodiments of the docking device in this specification, above, it has been generally described with regard to assisting in fixing the replacement valve at the mitral position. However, as described above, the above-described docking device or a slightly modified embodiment thereof can also be similarly applied to valve replacements at other valve sites, such as the tricuspid valve position, the pulmonary artery position, or the aorta position. A patient diagnosed with dysfunction at any position may have a valve loop that hypertrophies, preventing the natural valve from joining properly, and the valve loop may become overly large, overly soft, or other diseases may become prominent and it may no longer be possible to firmly hold the expandable valve. Therefore, using a docking device having rigidity or semi-rigidity is also advantageous in fixing the replacement valve at those valve sites, for example, to prevent the replacement valve from shifting during normal cardiac function.

[0127] The docking device in this specification can, as described above, be further covered with one or more coatings or cover layers. Further, the cover layer for any of these applications can be made of or include a material that promotes more rapid internal growth of the tissue. The cover layer can be further configured to have a larger surface area, for example, by a velour membrane, a porous surface, a knitted surface, etc., to further enhance the internal growth of the tissue.

[0128] Docking devices similar to the above-described docking device can, when applied to valves other than the mitral valve, also form a more reliable loading zone at those sites. The docking device and the related replacement valve can be applied in the same manner 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 valve replacement can be transfemoral access. However, access to each valve site is not limited to these. When using a coiled docking device as described above at 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, enabling the natural valve leaflets to be circumferentially tightened or fastened after deploying the replacement valve at the location of the natural valve loop. Further, slippage or other movement of the docking device and slippage or other movement of the sandwiched tissues relative to the docking device are further prevented, and unwanted growth or expansion of the natural valve loop over time is prevented.

[0129] Some possible attachment configurations between the anchor / docking device and the release or retrieval wire / suture, as well as the movement and / or slippage of each component, may, in some cases, cause the anchor / docking device to become T-shaped or "T-shaped" with respect to the pusher tube and / or delivery catheter, for example, such that the axis of the pusher tube and / or delivery catheter is misaligned (may be perpendicular) with the axis of the proximal end of the anchor / docking device. For example, when pulling on the retrieval wire / suture, the end 2700 of the docking device and the pusher device / tube 1165 and / or delivery catheter assume a non-aligned, orthogonal relative orientation or a substantially orthogonal relative orientation, for example, an orientation that forms a relative "T" shape. When this occurs, it may be difficult to retrieve or withdraw the anchor / docking device into the delivery catheter.

[0130] Any of the anchor / docking devices described herein can advantageously be configured and designed to suppress or prevent or resist becoming T-shaped or "T-ing up" in this way. For example, any of the anchor / docking devices described herein can be configured to have a curved proximal end that can more easily be guided into the pull delivery catheter without being pinched at the edge of the catheter and / or without shifting or becoming perpendicular to the pusher tube and the catheter. Additionally or alternatively, any of the anchor / docking devices described herein can be configured to bias (or bias in the direction of alignment) the line of force F applied by the retrieval suture / thread 1163 to be aligned or substantially aligned with the central axis or the moment of inertia A with respect to the region of the end 2700 of the docking device (see FIG. 27). This alignment can help to suppress and / or prevent the end 2700 of the docking device from sliding or moving relative to one side of the pusher device or the tube 1165 when the retrieval 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 to suppress and / or prevent a T-shaped or "T-ing" effect between the end 2700 of the docking device and the pusher tube 1165 and / or the delivery catheter. Although the following embodiments / designs, which include one or more special mechanisms for suppressing and / or preventing the end 2700 of the docking device from becoming T-shaped and shifting relative to the pusher device or the tube 1165 and / or sliding on one side of the pusher device or the tube 1165, will be described mainly with reference to the docking device 1100, it will be understood that any of the docking device embodiments disclosed herein can 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 when moving towards the pusher tube 1165 and / or the delivery catheter. In some configurations, in some cases, the end 2700 may move or slide into the above-described "T-shaped" posture. For example, in some potential configurations, when the suture release hole 1162 faces radially outward on the docking device 1100, the line of tension F from the release suture 1165 to the end 2700 may not be aligned with the moment of inertia A about the axis or region of the end 2700 of the anchor / docking device. If the angle between the line of tension F and the axis A of the end of the docking device 1100 is too large, when attempting to retrieve the docking device 1100, the end 2700 of the docking device 1100 slides beyond the distal tip of the pusher tube 1165, deviates from the aligned abutting state, and moves the docking device 1100 into a "T-shaped" posture with respect to the pusher tube 1165, thereby making it more difficult to retrieve it into the delivery catheter 1010.

[0132] Referring to FIGS. 27A-30B, an exemplary embodiment of the docking device 1100 includes a proximal connection end or tip to maintain alignment or substantial alignment between the line of force F applied by the retrieval suture / line 1163 and the moment of inertia A about the central axis or region of the end 2700 of the docking device. In the example shown by FIGS. 27A-27F, the docking device 1100 may include a connection end / tip or spherical end / tip 1200 that is integrated with or formed or machined on 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 a suture, welding, adhesive, or other methods known in the art.

[0133] The spherical end or tip (e.g., ball-shaped end or tip) can take on a variety of different forms. In the examples shown by FIGS. 27D - 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 in a distal position relative to the spherical portion 1202 and is connected 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 such that it forms a continuous part of the coil / core 1160 of the docking device 1100 or fits as a cap on 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 that extends along a tip axis AT aligned with the moment of inertia A about an axis or region from the center / end of the spherical portion 1202 (FIG. 27A). The central passage extends through the spherical proximal tip 1200 to the center of the spherical portion 1202. In the illustrated example, two diagonal side passages 1212 extend to the central passage 1210. The illustrated passages 1212 begin at a location on the outer surface of the spherical portion 1202 that is distal to the center of the spherical portion 1202. The side passages 1212 define a pair of openings external to the spherical proximal tip 1200. In the illustrated example, the side passage openings are disposed substantially at the point where the spherical portion 1202 and the transition portion 1204 converge. However, the side passage openings can be provided at a variety of different locations. In the illustrated embodiment, the side passages 1212 merge and open into the central passage 1210 at the center of the substantially spherical portion 1202. The central passage 1210 and the side passages 1212 can define a smooth bifurcated passage. In an exemplary embodiment, the edges of the openings of the passages 1210, 1212 and / or the intersections of the passages 1212 and the passage 1210 can be smoothed or rounded. The central passage biases a suture passing therethrough to align (in the aligning direction) with the central axis or longitudinal axis of the tip 1200 and the end of the docking device. The tip / end 1200 can include a coating that covers it.

[0135] Although the spherical tip 1200 has been described as having a central passage 1210 and two side passages 1212, it will be appreciated that other designs are possible. For example, the tip 1200 can include a central opening at the proximal end of the tip 1200, and two diagonal passages can extend directly from the central opening. The two diagonal passages can open into the central opening and extend distally and radially outward from the central opening.

[0136] Referring to FIG. 27C, in use, one end of the retrieval or release suture / thread 1163 is passed through one of the central passage 1210 and the side passage 1212, disposed around the outer surface of the tip 1200, passed through the other side passage 1212, and exits from the central passage 1210. Both ends of the suture / thread 1163, when passed in such a manner, extend from the proximal end of the central portion of the spherical connection tip 1200, whereby the line of the tension or force F applied to the tip 1200 by the suture / thread 1163 is aligned with the longitudinal axis A of the end 2700 and the axis AT of the central passage of the tip 1200.

[0137] In an exemplary embodiment, due to the spherical shape of the spherical portion 1202, the distal end of the pusher tube 1165 and / or the delivery catheter 1010 can rotate or pivot relative to the proximal portion of the docking device 1100 without the tip 1200 being displaced from the end of the pusher tube and / or without the delivery catheter 1010 assuming a T-shape with respect to the catheter 1010. When the line of the tension F is aligned with the axis A, AT and / or the spherical proximal end of the tip 1200, the docking device 1100 and the pusher tube 1165 and / or the delivery catheter 1010 are prevented from being displaced relative to each other to form a T-shape.

[0138] Referring to FIG. 27E, the spherical proximal tip / end 1200 may include a bore 1230 at the distal end of the tip 1200 in some cases and can 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 can have a cylindrical, conical, or other shape. Further, the spherical proximal tip 1200 may include an eyelet 1240 or slot extending through the tip / end 1200 in the neck portion 1206 in some cases. A suture can be passed through the eyelet 1240 and through the hole 1162 (see FIG. 22) of the coil / core 1160 to connect the spherical tip 1200 to the coil / core 1160. An optional coating / cover layer can be provided on a portion of the tip 1200, such as the coil / core and / or the neck portion 1206. The optional coating layer can also be attached using the eyelet or slot 1240 and the hole 1162.

[0139] The spherical connection tip / end 1200 can be integrated with the docking device 1100, machined onto the proximal end of the docking device 1100, or can be a cap attached to the proximal end of the docking device by suture, welding, or other attachment means. The position of the central passage 1210 and the side passage 1212 allows for the use of a thicker wall, thereby making the spherical tip / end 1200 more robust.

[0140] The spherical tip 1200 can be configured and designed such that the distal portion has a diameter larger than that of the end 2700 of the docking device 1100 (FIG. 27A), or the distal portion forms the same plane as the end 2700 (FIG. 27G). The tip / end 1200 can be integrated with the docking device so as not to require a bore 1230 or a bore base 1232. Or when the distal portion of the tip 1200 forms the same plane as the end 2700 of the docking device, the proximal end of the end 2700 can be machined or otherwise reduced in diameter so as to be received in the bore 1230 of the spherical proximal tip 1200. Other ways of attaching the spherical proximal tip 1200 so as to form the same plane as the end 2700 of the docking device 1100 are also conceivable.

[0141] The spherical connection tip / end can be made in a variety of different ways. In an 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 machining or micromachining. Electroplating can be used to form a radius on the edge. In an 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 (polyetheretherketone), 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 an exemplary embodiment, the spherical tip / end can be configured to withstand a force F of 130 Newtons applied by a suture thread without bending or breaking.

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

[0143] Furthermore, the edge between the bore 1230 and the bore base 1232 can be rounded. The rounded edge can have a radius between about 0.1 mm and 0.4 mm, such as about 0.20 mm. The bore 1230 can extend proximally 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 from the distal end to the tip 1200.

[0144] Furthermore, in the illustrated embodiment, the eyelet 1240 is shaped to have two semi - circles on both sides 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 semi - circular portion 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 can be between 0.7 mm and 1.1 mm, for example, between about 0.8 mm and 1.0 mm, for example, about 0.9 mm.

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

[0146] Referring to FIG. 28C, one end of the release suture 1163 is passed through one of the central passage 1210 and the side passage 1212, around a part of the annular recess 1220, through the other side passage 1212, and out of the central passage 1210. When both ends of the release suture 1163 are passed in this way, they extend from the proximal and central portions of the tip 1200, so that the line of the tension or force F applied to the tip 1200 by the release suture 1163 is aligned with the longitudinal axis A of the end 2700 and the axis AT of the central passage of the tip 1200. When pushing, retrieving, or otherwise repositioning the docking device 1100, a part of the release suture 1163 can remain within the annular recess 1220. The pusher tube 1165 and the catheter 1010 are shown relatively short compared to the spherical proximal tip 1200, but the pusher tube 1165 and the 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 pivot relative to the proximal portion of the docking device 1100 without the tip 1200 deviating from the end of the pusher tube. When the line of the tension F is aligned with the axis A, AT and / or the spherical proximal end of the tip 1200, the docking device 1100 and the pusher tube 1165 are prevented from shifting relative to each other and forming a T-shape.

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

[0148] In the exemplary embodiment shown by FIGS. 28A-28E, the spherical proximal tip 1200 can have a length between about 4.4 mm and 4.8 mm, for example, about 4.6 mm. The spherical portion 1202 can have a length between 0.9 mm and 1.3 mm, for example, between about 1.0 mm and 1.2 mm, for example, about 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, about 2.20 mm. The neck portion 1206 can have a length between 1.8 mm and 2.2 mm, for example, between about 1.9 mm and 2.1 mm, for example, about 2.00 mm, and an outer diameter between 1.65 mm and 2.05 mm, for example, between about 1.75 mm and 1.95 mm, for example, about 1.85 mm. The transition portion 1204 can have an overall length of about 1.5 mm. The transition portion 1204 can curve and decrease in diameter when merging with the spherical portion 1202 and the neck portion 1206. The annular indentation 1220 can take various different forms. The annular indentation 1220 can have a single diameter (when viewed in cross-section), or can have two or more different diameters. In an exemplary embodiment, the diameter of the annular indentation 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 portion 1204 and the annular indentation 1220 can have any size and shape.

[0149] In FIGS. 28A to 28E, the opening of the central passage 1210 is stadium-shaped and can have a length 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 0.40 mm and 0.80 mm, for example, between about 0.50 mm and 0.70 mm, for example, about 0.60 mm. The angle formed between the longitudinal axis of the central passage 1210 and the longitudinal axis of the side passage 1212 may be from 130° to 160°, for example, from about 140° to 150°, for example, 146°. The side passage 1212 can have a diameter between 0.40 mm and 0.80 mm, for example, between about 0.50 mm and 0.70 mm, about 0.60 mm.

[0150] Furthermore, the bore 1230 can be circular and can have 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 extends proximally from the distal end to the tip 1200 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 semi-circles on both sides 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 semi-circular portion 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 about 0.8 mm and 1.0 mm, for example, about 0.9 mm.

[0151] Figures 29A - 29E illustrate an exemplary embodiment of the docking device 1100. In the example shown by Figures 29A - 29E, the docking device 1100 includes a looped proximal tip or end 1300 (e.g., includes a loop at the proximal tip / end). The looped proximal tip 1300 can be formed by machining or a similar process. The looped proximal tip 1300 can be formed in a variety of different ways. Referring to Figure 29C, in an 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 an inner loop surface 1310, an outer loop surface 1312, and a suture receiving region H. The release suture 1163 is then looped through the suture receiving region H, and the release suture 1163 is used to retrieve the docking device 1100 as described above. When the docking device 1100 is pushed using the pusher tube 1165, the distal end of the pusher tube 1165 may abut the outer loop surface 1312 and may rotate or pivot along the outer loop surface 1312. The looped portion of the release suture 1163 can rotate along the inner loop surface 1310, such that the line of tension F applied by the release suture 1163 becomes substantially aligned or aligned with the moment of inertia A about 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, the pusher tube 1165, and / or the catheter 1010 from shifting relative to each other. The pusher tube 1165 and the catheter 1010 are shown relatively short compared to the looped proximal tip 1300 in Figure 29B, but the pusher tube 1165 and the catheter 1010 can be extended to any desired length.

[0152] Referring to FIGS. 29C and 29D, in an exemplary embodiment, the loop-shaped proximal tip 1400 can be made by cutting or shaving 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 FIGS. 29C-29E, the proximal portion of the tip 1400 is shaved to define a flat longitudinal surface 1302 that extends to the distal point 1304 along the length of the coil / core 1160. In a further exemplary embodiment, 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. The flat longitudinal surface 1302 is then folded towards the distal point 1304 to define an inner loop surface 1310 and is connected to the remaining portion of the coil / core 1160 at the connection point 1306 near the distal point 1304. In an exemplary embodiment, the proximal end of the flat longitudinal surface 1302 is welded at the connection point 1306. However, other methods of connecting the flat longitudinal surface 1302 to the connection point 1306, such as heat treatment, use of an adhesive, etc., are contemplated, or the surface 1302 may abut the point 1306 without a direct connection.

[0153] The loop-shaped proximal tip 1300 is designed and configured to slide smoothly through the delivery catheter. The lateral edges of the flat longitudinal surface 1302 can be rounded. The outer loop surface 1312 can be rounded to form a smooth transition to the remaining portion 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, breaking, breaking a weld, or collapsing the loop. However, the tip 1300 can be made of 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 FIG. 29E, the loop-shaped proximal tip 1300 can 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 can have a size such that a suture or other attachment device can be fitted into the bore 1340 and the bore 1340 can be rounded and smoothed. The coating can extend, for example, to a point between the bore 1340 and the connection point 1306.

[0155] In the illustrated embodiments shown in FIGS. 29A - 29E, the coil / core 1160 can have various 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 an exemplary embodiment of a docking device 900 or a core of a docking device configured such that the line of force F applied by the retrieval suture 1163 aligns with the central axis of the end 2700 of the docking device or the center of mass A with respect to the region. In the illustrated example, the proximal end of the docking device 900 can include a concave channel or groove 950. The illustrated proximal end of the docking device 900 is similar to the proximal end shown in FIGS. 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 proximal ends of other designs having different shapes or configurations, as will be described later.

[0157] The groove 950 can be provided at the proximal free end of the coil / core 910, whereby the central axis extending through the groove 950 is aligned with the axis extending through the hole 912. That is, the center of the groove 950 is aligned 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 FIG. 30B). The groove 950 defines two proximal free ends 918a and 918b on both sides of the groove 950. A proximal concave end 919a is formed concave and parallel to the proximal free ends 918a and 918b from the proximal free ends 918a and 918b. The groove wall 919b extends vertically and connects the proximal concave end 919a to the proximal free ends 918a and 918b. Proximal protrusions 915a and 915b are located between the groove 950 and the sides of the coil / core 910. The groove 950 and the resulting proximal protrusions 915a and 915b can be of any size capable of looping the suture and maintaining it in a predetermined position between the groove 950 and the hole 912. In an exemplary embodiment, the protrusions 915a and 915b are configured to be short and close enough to avoid catching on the catheter 1010 when pushing, retrieving, or positioning the docking device 1100.

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

[0159] Insert the suture 941 and / or the retrieval suture / thread 1163 into the slit hole 912, arrange them in a loop around the groove 950, and tie or otherwise secure them as a closed loop. The suture 941 and / or the retrieval suture / thread 1163 stay within the groove 950 and are looped through the groove 950 tightly enough that they do not shift or move radially outward from either of the proximal protrusions 915a, 915b. In some cases, the groove can be of other shapes, for example, cross-shaped, and the suture 941 and / or the retrieval suture / thread 1163 can be tied or otherwise secured to the cross-shaped groove to further prevent the suture 941 and / or the retrieval suture / thread 1163 from shifting or moving.

[0160] As shown in FIG. 30B, the distal end of the retrieval suture / thread 1163 can be attached to the suture 941 (alternatively, as described above, the retrieval suture / thread 1163 can be directly attached to the docking device within the groove 950, and a separate suture 941 is not required and is not used). In one embodiment, the suture / thread 1163 can be looped around the suture 941 or tied to the suture 941. When the release suture 1163 is pulled or otherwise drawn in, tension is applied to the suture 941, and the suture 941 then pulls the docking device 900 toward the pusher tube 1165. Since the suture 941 remains looped around the slit hole 912 and the groove, the line of 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 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 being displaced from the pusher tube 1165. The pusher tube 1165 and the catheter 1010 are shown relatively short compared to the proximal end of the docking device, but the pusher tube 1165 and the catheter 1010 can extend to any length.

[0161] In one embodiment, the retrieval suture / thread 1163 can be looped around the docking device or directly tied to the docking device. When the release suture / thread 1163 is pulled or otherwise drawn in, tension is applied to the docking device, whereby the docking device 900 is pulled toward the pusher tube 1165. Since the retrieval suture / thread 1164 remains tied around the slit hole 912 and the groove 950, the line of 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 being displaced from the pusher tube 1165.

[0162] Returning again to FIGS. 30A and 30B, it is possible to round the illustrated rectangular edges and corners or the grooves 950 and the slit holes 912. The illustrated embodiment shows the docking device 900 as being similar to the docking device of FIG. 25 and being substantially flat or having a rectangular cross-section, but the proximal end can have any shape that fits onto the delivery catheter. For example, the proximal end can be circular or oval and can have a U-shaped groove or other rounded groove. Further, grooves or channels can be included in the looped proximal end 1300 of FIGS. 29A-29E.

[0163] The embodiments of FIGS. 30A and 30B can include any number of slits and grooves. For example, the proximal end of the coil / core 910 can have two grooves (or any number) perpendicular to each other and two slit holes (or any number). Suture threads are looped through and fixed to each of the slit holes and grooves. Then, a release suture can be attached to the two suture threads at the center of the two grooves, such that the applied tension remains aligned between the coil / core 910 and the pusher tube 1165.

[0164] In this description, some aspects, advantages, and novel special mechanisms of embodiments of the present disclosure have been described herein. The disclosed methods, devices, and systems are not to be construed as limiting in any way. Instead, the present disclosure is directed to all novel non-obvious special mechanisms and aspects of the various disclosed embodiments, both individually and in various combinations and sub-combinations thereof. The methods, devices, and systems are not limited to any particular aspect or special mechanism or combination thereof, can be combined, and the disclosed embodiments do not require the presence of any one or more particular advantages or the solving of any problems.

[0165] Although the operations of some of the disclosed embodiments are described in a particular order for presentation purposes, it should be understood that this manner of description encompasses rearrangement unless a particular order is required by the specific language being described. For example, operations or steps described sequentially may in some cases be rearranged or performed concurrently. Further, for simplicity of explanation, the accompanying figures may not show various ways of using the disclosed method in conjunction with other methods. Additionally, the description may use terms such as "provide" or "implement" to describe the disclosed method. These terms abstract the actual operations being performed to a higher level. The actual operations corresponding to these terms may vary depending on the particular implementation and will be recognizable to those of ordinary skill in the art.

[0166] Considering the numerous possible embodiments to which the principles of the present disclosure can be applied, it should be recognized that the illustrated embodiments are merely preferred examples and should not be regarded as limiting the scope of the present disclosure. Rather, the scope of the present disclosure is defined by the following claims.

Description of Reference Numerals

[0167] 1, 100, 200, 300, 400, 500, 600, 1100 docking device 10, 110, 1110 central region 20, 120, 1120 lower region 21 distal tip 21 distal or guiding tip 30, 130, 1130 upper region 31 proximal tip 32 major axis 33 minor axis 40 artificial valve 41 expandable frame structure 42 valve tip 50 mitral valve 52 left atrium 54 left ventricle 56 aortic valve 58 aorta 62 Chordae tendineae 64 Junction 66 Anterior cusp 68 Posterior cusp 140, 1140 Extension region 150 Hole 210 Laser cut tube 211, 216, 217, 218 Notch 212 Link 213, 218 Tooth 214, 618 Groove 215 End region 217 Opening 219 Locking wire 219 Tension wire 222 Distal end 310, 510 Main coil 320 Anchor 410, 610, 710, 810, 910 Coil / Core 420 Coating 520 Friction element 530 High friction coating 622 Protrusion 712 Tip 714 Through hole 716, 918 Free end 718 Opposite end 720 Fixing hole 812 Ball tip 814 Gap 912 Slit hole 914, 916 Side part 915a, 915b Proximal protrusion 919a, 919b Proximal concave groove 920 Cover layer 930 Suture 940 Pull wire 941 Suture 950 Groove 1000 Guide sheath, introducer 1010 Delivery catheter 1160 Wire core 1162 Hole 1163 Suture 1164 Fixing hole 1165 Pusher tube 1170 Cover layer, low friction layer 1180 High friction layer, braided layer 1182, 1184 Marker band 1200 Spherical proximal tip / end 1202 Spherical part 1204 Transition part 1206 Neck part 1210 Central passage 1212 Side passage 1220 Channel, annular depression 1230 Bore 1232 Bore base 1240 Eyelet 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. 1. A system for implanting a docking device at a native valve, comprising: A delivery catheter; an elongated coiled docking device having an end; a pusher device having a central lumen 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 pulling the retrieval line pulls the end of the coiled anchor relative to the pusher device; A system in which the end and the retrieval line are configured and coupled such that the tension from the pulling is biased to be substantially aligned with a central axis of the end of the coiled docking device.

2. The system of claim 1 , wherein the end portion is configured to align at least a lengthwise portion of the retrieval line along the central axis.

3. The system of claim 1 , wherein the retrieval line extends through a central passage at the distal end of the end of the docking device, the central passage being aligned with the central axis.

4. The system of claim 1 , wherein the docking device further comprises a spherical tip.

5. The system of claim 4 , wherein the spherical tip receives the retrieval line through a passage aligned with a central axis of the end of the coiled docking device.

6. The system of claim 5 , wherein the spherical proximal tip comprises an annular groove at a transition portion of the spherical proximal tip.

7. The system of claim 1 , wherein a distal end of the pusher device is configured to engage a spherical surface at the end of the coiled anchor.

8. The system of claim 1 , wherein the end of the docking device comprises a tip including a loop, and the return line is connected to the loop.

9. The system of claim 1 , wherein the end of the docking device comprises a tip including a groove, and a retrieval suture is coupled to the end within the groove.

10. The coiled docking device comprises: at least one center turn having a first thickness and defining a center turn diameter; an extension having a length extending from a proximal end of the at least one center turn, the extension having a second thickness less than the first thickness; a proximal turn extending from a proximal end of the extension, the proximal turn having a third thickness greater than the second thickness; 10. The system according to claim 1 , comprising:

11. 11. The system of claim 10, wherein the coiled docking device comprises a distal turn on an opposite end of the coiled docking device relative to the end, the distal turn having the first thickness and defining a diameter greater than the central turn diameter.

12. The system of claim 10 , wherein the end of the coiled docking device is located at a proximal end of the proximal turn.

13. 11. The system of claim 10, wherein the coiled docking device is configured to be implanted at a native valve, and at least a portion of the coiled docking device is positioned within a chamber of the heart and around the leaflets of the native valve.

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

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

16. 16. The system of claim 1, further comprising a cover layer comprising a biocompatible material, the cover layer surrounding at least a portion of the coiled anchor.

17. the 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 a length of the coiled docking device, past a distal tip of the coiled docking device, and past a proximal tip of the coiled docking device; 17. The system of claim 16, wherein the low friction cover layer tapers to a rounded tip at a distal end thereof.

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

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

20. The coiled docking device comprises: at least one center turn defining a center turn diameter; a lower turn extending from the at least one central turn defining a diameter greater than the central turn diameter; an upper turn connected to the at least one central turn, the upper turn shaped to have a first diameter along a first axis and a second diameter along a second axis; 20. The system of claim 1, wherein the first shaft diameter is larger than the center winding diameter and the second shaft diameter is larger than the center winding diameter and smaller than the lower winding diameter.

21. The coiled docking device comprises: a hollow tube having a proximal end and a distal end; a plurality of cuts extending through portions of the hollow tube; a wire having a length, a proximal end and a distal end; Equipped with the distal end of the wire is secured to the distal end of the hollow tube and the proximal end of the wire is secured to the proximal end of the hollow tube; 21. The system of claim 1, wherein the length of wire extends through the hollow tube and applies a radially inward tension to the hollow tube.

22. 22. The system of claim 21, wherein the cuts have a pattern and shape incorporating both longitudinal and transverse cuts that form teeth and grooves in the hollow tube.

23. 23. The system of claim 1, wherein the coiled docking device includes a core, the distal end of the core having a rectangular cross-section and a distal wound ring-shaped tip.

24. 23. The system of claim 1, wherein the coiled docking device includes a core, at least one end of the core having a ball-shaped tip.

25. 1. A docking device for docking a prosthetic valve at a native heart valve, comprising: a coiled docking device having an end portion including a central axis; A docking device configured such that the end of the docking device is biased such that a retrieval suture connected to the end is biased such that lines of force exerted on the retrieval suture by tension are aligned with the central axis.

26. The device of claim 25, wherein the ends are configured to align at least a lengthwise portion of the retrieval suture along the central axis.

27. 26. The device of claim 25, wherein the retrieval suture extends through a central passage at the distal end of the end of the docking device, the central passage being aligned with the central axis.

28. 26. The device of claim 25, wherein the coiled docking device further comprises a bulbous tip on the proximal end for receiving the retrieval suture.

29. 30. The device of claim 28, wherein the spherical tip comprises an annular groove at a transition of the spherical tip.

30. 26. The device of claim 25, wherein the end of the docking device comprises a tip including a groove, and the retrieval suture is coupled to the end with a portion of the retrieval suture tied into the groove.

31. The coiled docking device comprises: at least one center turn having a first thickness and defining a center turn diameter; an extension having a length extending from a top end of the at least one center turn, the extension having a second thickness less than the first thickness; an upper turn extending from an upper end of the transition section, the upper turn having a third thickness greater than the second thickness; 31. A device according to any one of claims 25 to 30, comprising:

32. 32. The device of claim 31 , wherein the coiled docking device comprises a distal turn on an opposite end of the coiled docking device relative to the end, the distal turn having the first thickness and defining a diameter greater than the central turn diameter.

33. 32. The device of claim 31, wherein the coiled docking device is configured to be implanted at a native valve, with at least a portion of the coiled docking device positioned within a chamber of the heart and around the leaflets of the native valve.

34. 34. The device of claim 33, wherein the coiled docking device is configured to be implanted at a native mitral valve, and at least a portion of the coiled docking device is positioned within a left ventricle and around the mitral valve leaflets of the native mitral valve.

35. 34. The device of claim 33, wherein the coiled docking device is configured to be implanted at a native tricuspid valve, at least a portion of the coiled docking device being positioned within a left ventricle and around the tricuspid leaflets of the native tricuspid valve.

36. 36. The device of any one of claims 25 to 35, further comprising a cover layer comprising a biocompatible material, the cover layer surrounding at least a portion of the coiled anchor.

37. the 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 a length of the coiled docking device, past a distal tip of the coiled docking device, and past a proximal tip of the coiled docking device; 37. The device of claim 36, wherein the low friction cover layer tapers to a rounded tip at a distal end thereof.

38. 37. The device of claim 36, further comprising a friction-enhancing element comprising a second cover layer surrounding and extending along at least a portion of the cover layer, the second cover layer having a coefficient of friction of at least 1.

39. 40. The device of claim 38, wherein the second cover layer is a knitted material.

40. The coiled docking device comprises: at least one center turn defining a center turn diameter; a lower turn extending from the at least one central turn defining a diameter greater than the central turn diameter; an upper turn connected to the at least one central turn, the upper turn shaped to have a first diameter along a first axis and a second diameter along a second axis; Equipped with 40. The device of any one of claims 25 to 39, wherein a diameter of the first shaft is larger than the center winding diameter and a diameter of the second shaft is larger than the center winding diameter and smaller than the lower winding diameter.

41. The coiled docking device comprises: a hollow tube having a proximal end and a distal end; a plurality of cuts extending through portions of the hollow tube; a wire having a length, a proximal end and a distal end; Equipped with the distal end of the wire is secured to the distal end of the hollow tube and the proximal end of the wire is secured to the proximal end of the hollow tube; 41. The device of any one of claims 25 to 40, wherein the length of wire extends through the hollow tube and applies a radially inward tension to the hollow tube.

42. 42. The device of claim 41, wherein the cuts have a pattern and shape incorporating both longitudinal and transverse cuts that form teeth and grooves in the hollow tube.

43. 43. The device of any one of claims 25 to 42, wherein the coiled docking device includes a core, a distal end of the core having a rectangular cross-section and a distal wound ring-shaped tip.

44. 43. The device of any one of claims 25 to 42, wherein the coiled docking device includes a core, at least one end of the core having a ball-shaped tip.

45. 1. A method for retrieving a coiled docking device from within a heart, comprising: pulling a retrieval line to pull an end of a coiled docking device against a pusher device, the end of the coiled docking device configured to bias the retrieval line to align tension applied by the pulling step with a central axis of the end of the coiled docking device; retracting a pusher device and the end of the coiled docking device into a delivery catheter; The method includes:

46. The method of claim 45, wherein the pusher device abuts a spherical end of the coiled docking device.

47. 46. ​​The method of claim 45, wherein the end aligns at least a portion of the return line along the central axis.

48. 46. ​​The method of claim 45, wherein the retrieval line extends through a central passage at the end tip of the docking device, the central passage being aligned with the central axis.

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