Heart valve docking coils and systems

Abstract

To effectively anchor or retain a valve at a mitral position.SOLUTION: Anchoring or docking devices 100 are configured to be positioned at a native valve of a human heart and to provide structural support for docking a prosthetic valve therein. The docking devices can have coiled structures that define an inner space in which the prosthetic valve can be held. The docking devices can have enlarged end regions with circular or non-circular shapes, e.g., to facilitate implantation of the docking device or to better hold the docking device in position once deployed. The docking devices can be laser-cut tubes with locking wires. The docking devices can include various features to promote friction, such as frictional cover layers. Such docking devices can have ends configured to securely attach the cover layers to cores of the docking devices.SELECTED DRAWING: Figure 10

Description

[Technical field]

[0001] The present invention relates generally to medical devices and procedures related to prosthetic heart valves. More specifically, the present invention relates to the replacement of potentially malformed and / or dysfunctional heart valves. Embodiments of the present invention relate to anchor or docking devices that can hold and maintain the positioning of a prosthetic heart valve to replace the function of a native heart valve, for example for mitral or tricuspid valve replacement procedures. The present invention also relates to positioning procedures associated with the implantation of such anchor or docking devices and / or the implantation of an assembly including an anchor or docking device and a prosthetic heart valve.

[0002] RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 62 / 395,940, filed September 16, 2016. This application also claims priority to U.S. Provisional Patent Application No. 62 / 380,117, filed August 26, 2016. These two applications, as well as U.S. Patent Application No. 14 / 372,953, filed July 17, 2014, entitled "Mitral Valve Docking Devices, Systems and Methods," are hereby incorporated by reference in their entireties. [Background technology]

[0003] 1 and 2, the mitral valve 50 controls blood flow between the left atrium 52 and the left ventricle 54 of the human heart. After the left atrium 52 receives oxygenated blood from the lungs via the pulmonary veins, the mitral valve 50 allows the flow of oxygenated blood from the left atrium 52 to the left ventricle 54. When the left ventricle 54 contracts, the oxygenated blood held within the left ventricle 54 is delivered to the rest of the body through the aortic valve 56 and the aorta 58. Meanwhile, the mitral valve should be closed during ventricular contraction to prevent any blood from flowing back into the left atrium.

[0004] When the left ventricle contracts, the blood pressure in the left ventricle increases substantially, which acts to encourage the mitral valve to close. During this time, because there is a large pressure difference between the left ventricle and the left atrium, a large amount of pressure is exerted on the mitral valve, which can lead to mitral valve prolapse or the leaflets everting back into the atrium. A series of chordae tendineae 62 therefore connect the leaflets of the mitral valve to the papillary muscles located in the wall of the left ventricle, where both the chordae tendineae and the papillary muscles are pulled during ventricular contraction to hold the leaflets in a closed position and prevent them from everting back into the left atrium. This helps to prevent oxygenated blood from flowing back into the left atrium. The chordae tendineae 62 are shown diagrammatically in both the cross-sectional view of the heart in FIG. 1 and the superior view of the mitral valve in FIG. 2.

[0005] The general shape of the mitral valve and its leaflets as viewed from the left atrium is shown in FIG. 2. The commissure 64 is located at the end of the mitral valve 50 where the anterior leaflet 66 and the posterior leaflet 68 come together. Various complications of the mitral valve can cause fatal heart failure. One form of valvular heart disease is mitral valve leakage or mitral valve regurgitation, which is characterized by abnormal leakage of blood from the left ventricle back through the mitral valve into the left atrium. This can occur, for example, when left ventricular dilation causes the native mitral valve leaflets to not fully coapt, resulting in damage to the native leaflets or weakening (or damage) of the chordae tendineae and / or papillary muscles causing leakage. In these circumstances, it may be desirable to repair the mitral valve or to replace the function of the mitral valve with that of a prosthetic heart valve.

[0006] With regard to valve replacement, open surgical options are more readily available, but there has been much less progress with respect to commercial methods for replacing the mitral valve via catheterization and / or other minimally or minimally invasive procedures. Mitral valve replacement is in many ways more challenging than aortic valve replacement due, for example, to the non-circular physical structure of the mitral valve, its subannular anatomy, and more difficult access to the valve. Summary of the Invention [Problem to be solved by the invention]

[0007] It may be beneficial to use an artificial aortic valve or a similar round or cylindrical valve prosthesis for mitral valve replacement. However, one of the most prominent obstacles for mitral valve replacement is effectively fixing or holding the valve in the mitral position because the valve is subjected to large cyclic loads. As mentioned above, another problem with mitral valve replacement is the size and shape of the native mitral annulus, as seen in Figure 2. The aortic valve is more round or cylindrical than the mitral valve. Also, both the mitral and tricuspid valves are larger than the aortic valve and more elongated in shape, making it more challenging and making it a non-conventional site to implant a replacement valve with a nearly circular or cylindrical valve frame. A circular prosthesis that is too small may result in peri-implant leakage (i.e., paravalvular leakage) if a good seal is not established around the valve, while a circular prosthesis that is too large may enlarge and damage the stenosis of the native mitral annulus. Furthermore, in many cases, the need for aortic valve replacement arises due to, for example, aortic stenosis, in which the aortic valve narrows due to calcification or other hardening of the native valve leaflets. Thus, the aortic annulus generally forms a more compact, rigid and stable fixation site for a prosthetic valve than the mitral annulus, which is larger and non-circular than the aortic annulus. Cases of mitral regurgitation are unlikely to provide such an excellent fixation site. Also, the presence of chordae tendineae and other anatomical structures at the mitral valve position may form obstacles that make it much more difficult to properly fix the device at the mitral valve position.

[0008] Other obstacles to effective mitral valve replacement may arise from the large cyclic loads to which the mitral valve is subjected, as well as the need to establish sufficiently strong and stable fixation and retention, and even slight misalignment of the valve may result in blood flow through the valve or other parts of the heart being obstructed or otherwise adversely affected. [Means for solving the problem]

[0009] 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.) would be to use an anchor (e.g., mitral valve anchor) or docking station that would form or otherwise bring a more circular docking site in the native valve position (e.g., mitral position) to hold such a prosthetic valve. In this way, existing expandable transcatheter valves developed for the aortic position, or similar valves slightly modified to more effectively replicate mitral valve function, could be more reliably implanted in such a docking station placed in the native annulus (e.g., native mitral annulus). The docking station is first placed into the native valve annulus, after which the valve implant or transcatheter heart valve may be advanced and placed through the docking station while in the collapsed position, and then expanded, for example, by self-expansion (e.g., for valves constructed with NiTi or other shape memory materials), balloon expansion, or mechanical expansion, which causes the frame of the prosthetic valve to press radially against the docking station and / or tissue between the two, holding the valve in place. Preferably, the docking station is also delivered minimally or minimally invasively, for example, via the same or similar transcatheter approach used for delivery of the transcatheter heart valve, such that implantation of the docking station prior to delivery of the prosthetic valve does not require a completely separate procedure.

[0010] It would therefore be desirable to provide apparatus and methods that can be utilized to facilitate docking or fixation of such valves. Embodiments of the present invention provide a stable docking station or docking device for holding a prosthetic valve (e.g., a prosthetic mitral valve). Other features are provided to improve the placement, positioning, stability, and / or integration of such docking stations and / or replacement prostheses intended to be held therein. These apparatus and methods may more securely hold the prosthetic valve and also prevent or significantly reduce blood regurgitation or leakage around the prosthetic valve. Such docking devices and methods may be used in various valve replacement procedures, for example, for mitral, tricuspid, pulmonary or aortic valve replacement, resulting in more secure and robust anchoring and retention of the valve annulus at the native annulus at these locations.

[0011] A docking device for docking a prosthetic valve to a native valve of the heart (e.g., mitral valve, tricuspid valve, etc.) may include various features, components, and characteristics. For example, such a docking device may include a coiled anchor having at least one central turn (e.g., a full or partial turn central turn) that defines a central turn diameter. The at least one central turn may be one or more functional turns / coils. The coiled anchor may also include a lower turn that defines a diameter greater than the central turn diameter extending from the at least one central turn. The lower turn may be a leading turn / coil. The coiled anchor may also include an upper turn connected to the central turn. The upper turn may be one or more stabilizing turns / coils. The upper turn may be shaped to have a first diameter along a first axis and a second diameter along a second axis. The first axial diameter of the upper turn may be greater than the diameter of the central turn, and the second axial diameter may be greater than the diameter of the central turn and less than the diameter of the lower turn. The various coiled anchors described herein can be configured to be implanted in a native valve (e.g., native mitral valve, tricuspid valve, etc.) with at least a portion of at least one central turn of the coiled anchor positioned within a chamber of the heart (e.g., left ventricle) and around the leaflets of the native valve.

[0012] Any of the coiled anchors described herein may include an extension having a length that extends from the top end of the at least one central turn to the top turn / coil or stabilizing turn / coil. The extension may have a smaller or reduced thickness compared to other portions of the coiled anchor, e.g., the at least one central turn, the top turn, the bottom turn, etc. The extension may extend perpendicularly at an angle between 60-120 degrees, between 70-110 degrees, between 80-100 degrees, or 90 degrees relative to the at least one central turn.

[0013] Various docking devices for docking a prosthetic valve to a native valve of the heart may have a coiled anchor (e.g., which may be the same as or similar to other coiled anchors described in this disclosure) having a proximal tip and a distal tip. The coiled anchor may include at least one central turn (e.g., a full or partial central turn, which may be the same as or similar to other central turns or functional turns described in this disclosure). The at least one central turn may have a first thickness and define a central turn diameter. Any of the coiled anchors described herein may include an extension having a length extending from a top end of the at least one central turn. The coiled anchor may also include a top turn (e.g., which may be the same as or similar to other top turns or stabilizing turns / coils described in this disclosure) extending from a top end of the extension. The extension may have a second thickness that is less than the first thickness. The top turn may have a third thickness that is greater than the second thickness. As described above, the coiled anchor can be configured to be implanted in a native valve (e.g., native mitral valve, tricuspid valve, etc.) with at least a portion of at least one complete or partial central turn of the coiled anchor positioned within a chamber of the heart (e.g., left ventricle) and around the leaflets of the native valve.

[0014] Various docking devices for docking a prosthetic valve to a native valve of the heart may also have a coiled anchor (e.g., may be the same as or similar to other coiled anchors described in this disclosure) having a proximal tip, a distal tip, and at least one central turn (e.g., a full or partial central turn that may be the same as or similar to other central turns / coils or functional turns / coils described in this disclosure) that defines a diameter. The coiled anchor may also have a top turn connected to the at least one central turn. A cover layer may surround the coiled anchor along all or at least a portion of the at least one central turn. The cover layer may be connected to the coiled anchor. At least one friction-promoting layer may be disposed over the coiled anchor and / or the cover layer. The at least one friction-promoting layer may be disposed over at least a portion of the at least one central turn. The coiled anchor may be configured such that no portion of the top turn is covered by the friction-promoting layer. The coiled anchor can be configured to be implantable in a native valve (e.g., a native mitral valve, etc.) with at least a portion of at least one central turn of the coiled anchor positioned within a chamber of the heart (e.g., the left ventricle) and around the leaflets of the native valve.

[0015] Any coiled anchor of any of the docking devices described herein may 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, a cover layer may surround all or at least a portion of at least one central turn (or all of the central turn / coil or functional turn / coil of the coiled anchor) and / or other portions of the coiled anchor. The cover layer may be connected to the coiled anchor in various ways. The cover layer may be a high friction cover layer, a low friction cover layer, or both low friction and high friction cover layers may be used together. The low friction cover layer may be configured to surround the core of the coiled anchor (e.g., the entire length of the coiled anchor) and extend beyond the proximal and / or distal tips. The low friction cover layer may be formed with a tapered or rounded tip at its distal and / or proximal tips. A high friction cover layer or a high friction cover layer (eg, higher than a low friction cover layer) may surround a portion of the low friction cover layer and / or a portion of the coiled anchor (eg, all or a portion of at least one central turn).

[0016] Any of the coiled anchors described herein may include at least one friction-promoting element or elements. The at least one friction-promoting element or elements may be disposed on all or a portion of the coiled anchor or a cover / layer on the coiled anchor. The at least one friction-promoting element may be or include a plurality of bulges on the surface of the coiled anchor or on the surface of the cover. The bulges may be made of PET, polymer, fabric, or other materials. The bulges may extend along the length of the coiled anchor or along at least a portion of the central turn / coil of the cover. Optionally, the at least one friction-promoting element may be or include a plurality of locking and key cutouts on the outer surface of the coiled anchor. The locking cutouts may be grooves formed in the outer surface of the coiled anchor and the key cutouts may be protrusions extending outwardly from the coiled anchor that may be dimensioned to fit into the locking cutouts.

[0017] A system for implanting a docking device in a native valve of the heart may include a docking device (e.g., any docking device described above or elsewhere in this disclosure). The docking device may include an opening or hole, and the system may include a suture passing through the opening or hole. The system may also include a delivery catheter and a pusher device disposed within the delivery catheter. The pusher device may include a central lumen that receives or through which the suture passes. The pusher device and suture may be configured such that pulling the suture pulls the coiled anchor relative to the pusher device, and retracting the pusher device into the delivery catheter retracts the coiled anchor into the delivery catheter. The suture may be disposed within the central lumen such that pulling the suture and / or the pusher device proximally relative to the delivery catheter retracts the coiled anchor or delivery device into the delivery catheter.

[0018] A docking device for docking a prosthetic valve to a native valve of the heart can have a coiled anchor including a hollow tube. The hollow tube can have a proximal locking mechanism and a distal locking mechanism. There can be multiple cuts through a portion of the tube. The cuts can have a pattern and shape incorporating one or both of longitudinal and transverse cuts. When the cuts have a pattern and shape incorporating both longitudinal and transverse cuts, they can form teeth and grooves in the hollow tube. The docking device can also have a wire, and a distal tip of the wire can be secured to the distal locking mechanism. A length of the wire (e.g., the entire length or a portion thereof) can extend through the hollow tube and apply a radially inward tension to the hollow tube. The hollow tube is configured to at least partially surround the leaflets of the native mitral valve and provide a docking surface for the expandable prosthetic valve.

[0019] The methods used to implant a docking device for a prosthetic valve in a native heart valve may include various steps (e.g., any of the steps described throughout this disclosure). The docking device implanted in these methods may be any of the docking devices described herein. For example, a docking device implantable using these steps may have a coiled anchor having at least one full or partial turn defining a central diameter, an extension having a length extending from an upper end of the at least one central turn, and an upper turn extending from an upper end of the extension. The distal tip of the delivery catheter may be positioned in a first chamber of the heart (e.g., the left atrium). Optionally, the delivery catheter may be advanced and positioned through a previously implanted guide sheath. The delivery catheter may house the docking device in a first configuration. The distal tip of the docking device may be advanced from the delivery catheter, such that the docking device assumes a second configuration as it advances and / or when it is implanted. The docking device is advanced through the valve annulus (e.g., the native mitral annulus) into the second chamber of the heart (e.g., the left ventricle) such that the distal tip loosely surrounds the chordae tendineae and native leaflets of the native valve (e.g., the mitral valve). The extension of the docking device can be advanced such that its upper end is located within the first chamber (e.g., the left atrium). The upper portion of the docking device can be advanced and released into the first chamber (e.g., the left atrium) such that the upper portion contacts the first chamber wall (e.g., the left atrial wall). A replacement prosthetic valve can be embedded in the docking device. For example, in the second configuration, the replacement valve can be inserted into the interior space defined by the docking device. To hold the replacement valve in a stable position, the replacement valve can be radially expanded until a retaining force is created between the replacement valve and the docking device. The native leaflets or other tissue can be clamped between the delivery device and the prosthetic valve.

[0020] Valve replacement may be accomplished by using a coiled anchor or docking device at the native valve site to dock an expandable transcatheter heart valve therein. The coiled anchor or docking device provides a more stable base or site against which a prosthetic valve can be expanded. Thus, embodiments of the present invention provide a more robust method for implanting a replacement heart valve, even at sites such as the native mitral annulus, where the annulus itself may be non-circular or otherwise variably shaped. [Brief description of the drawings]

[0021] Further features and advantages of the present invention will become apparent from the following detailed description of the preferred embodiments taken in conjunction with the accompanying drawings.

[0022] [Figure 1] 1 shows a schematic cross-sectional view of a human heart. [Diagram 2] 1 shows a schematic top view of the mitral valve annulus of the heart. [Diagram 3] 1 shows a perspective view of a coiled anchor according to a first embodiment of the present invention; [Figure 4] FIG. 4 shows a side view of the coiled anchor of FIG. [Diagram 5] FIG. 5 shows a plan view of the coiled anchor of FIGS. 3 and 4. [Figure 6] 6 shows a cross-sectional view of a portion of the heart during steps of delivering the coiled anchor of FIGS. 3-5 to the native mitral valve annulus. [Figure 7] 6 shows a cross-sectional view of a portion of the heart in a further step of delivering the coiled anchor of FIGS. 3-5 to the native mitral valve annulus. [Figure 8] FIG. 6 shows a cross-sectional view of a portion of a heart with the coiled anchor of FIGS. 3-5 positioned at the native mitral valve annulus. [Figure 9] FIG. 6 illustrates a cross-sectional view of a portion of a heart having the coiled anchor of FIGS. 3-5 and a prosthetic mitral valve implanted in the native mitral annulus. [Figure 10] FIG. 6 shows a perspective view of an improved version of the coiled anchor of FIGS. 3 to 5. [Figure 11]1A-1C are schematic diagrams illustrating an open view of a laser cut tube used as a coiled anchor according to one embodiment of the present invention. [Figure 11A] 1A-1C are schematic diagrams illustrating an open view of a laser cut tube used as a coiled anchor and tension wire according to one embodiment of the present invention. [Figure 12] FIG. 12 shows a top view of the laser-cut coiled anchor of FIG. 11 in an assembled state. [Figure 13] 12 shows a perspective view of the laser-cut coiled anchor of FIG. 11 in an assembled and actuated state with a prosthetic valve frame held therein. [Figure 14] FIG. 1 shows a top view of an improved coiled anchor having end hooks. [Figure 15] 1 shows a schematic diagram of another improved coiled anchor having a high friction cover layer. [Figure 16] 13 shows a schematic diagram of yet another improved coiled anchor having a friction element. [Figure 16A] 17 shows a cross-sectional view of the embodiment shown in FIG. 16. [Figure 17] FIG. 1 is a schematic diagram of a coiled anchor incorporating both a high friction cover and a friction element. [Figure 18] FIG. 13 illustrates yet another improved coiled anchor having surface features to facilitate interlocking or position retention between adjacent coils. [Figure 19] FIG. 11 illustrates an exemplary coiled anchor that is a variation of the coiled anchor of FIG. [Figure 19A] FIG. 1 is a cross-sectional view of one embodiment of a coiled anchor. [Figure 20] 1A-1C are schematic diagrams illustrating a top view of one embodiment of a coiled anchor implanted and positioned at a desired location in the native mitral valve annulus. [Figure 21] FIG. 20 shows the coiled anchor of FIG. 19 further including a marker band. [Figure 22] 20 shows a cross-sectional view of the proximal tip of the coiled anchor of FIG. 19. [Figure 22A]FIG. 1 illustrates one embodiment of a suture looped through a coiled anchor. [Figure 22B] 13A-13C show another embodiment of a suture looped through a coiled anchor. [Figure 22C] 13A-13C show an embodiment of a suture looped through a coiled anchor. [Diagram 23] FIG. 2 illustrates the distal tip of a coil skeleton or core of a docking device according to one embodiment of the present invention. [Figure 24] FIG. 13 illustrates the distal tip of a coil skeleton or core of a docking device according to another embodiment of the present invention. [Diagram 25] FIG. 1 illustrates the proximal tip of a coil skeleton or core of a docking device in accordance with an embodiment of the present invention. [Figure 26] Figure 25 shows the proximal tip of the docking device, with the cover layer attached over the coil scaffold or core. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0023] Disclosed herein are various coiled anchors or docking devices that can be used with expandable transcatheter heart valves (THVs) at the native valve annulus (e.g., mitral or tricuspid annulus) to more securely implant and retain the prosthetic valve at the implant site. The anchor / docking devices according to embodiments of the invention provide or form a more circular and / or more stable annulus at the implantation site into which a prosthetic valve having a circular or cylindrical valve frame or stent may be expanded or otherwise implanted. In addition to providing an anchoring site for the prosthetic valve, the anchor / docking devices can be sized and shaped to clamp or pull the native valve (e.g., mitral, tricuspid, etc.) anatomy radially inward. In this manner, one of the major causes of valve regurgitation (e.g., functional mitral regurgitation), particularly enlargement of the heart (e.g., left ventricle) and / or valve annulus, and the resulting stretching of the native valve annulus (e.g., mitral valve), can be at least partially counteracted or negated. Some embodiments of the anchor or docking device further include features that are shaped and / or modified to better retain the position or shape of the docking device during and / or after expansion of the prosthetic valve, for example. By providing such an anchor or docking device, the replacement valve may be more securely implanted and retained in a variety of valve annuli, including the mitral annulus, which does not have a naturally circular cross-section.

[0024] A coil-shaped anchor / docking device according to an exemplary embodiment of the invention is shown in Figures 3-5. Figure 3 shows a perspective view of anchor or docking device 1, Figure 4 shows a side view of the anchor, and Figure 5 shows a top view of anchor / docking device 1.

[0025] The docking device 1 includes a coil having multiple turns extending along a central axis of the docking device 1. The coil may be continuous and generally helical with a variety of different sized and shaped segments, as described in more detail below. The docking device 1 shown in Figures 3-5 is configured to best fit the mitral valve position, but may be similarly or differently shaped in other embodiments for better accommodation in other native valve positions.

[0026] The docking device 1 includes a central region 10 having approximately three full coil turns with a substantially equal inner diameter. The central region 10 of the docking device 1 serves as a primary landing or retention area for retaining an expandable prosthetic valve or THV when the docking device 1 and prosthetic valve are implanted within a patient. Other embodiments of the docking device 1 may have a central region 10 having more or less than three coil turns depending, for example, on the patient's anatomy, the amount of vertical contact desired between the docking device 1 and the prosthetic valve (e.g., THV) and / or other factors. The coils in the central region 10 may also be referred to as "functional coils" because the characteristics of these coils contribute most to the amount of retention force that is generated between the prosthetic valve, the docking device 1 and the native mitral valve leaflets and / or other anatomical structures.

[0027] Various factors may contribute to the total retention force between the docking device 1 and the prosthetic valve retained therein. The primary factor is the number of turns included in the functional coil, with other factors including, for example, the inner diameter of the functional coil, the frictional forces between the coil and the prosthetic valve, as well as the strength of the prosthetic valve and the radial force the valve exerts on the coil. The docking device may have a variety of coil turns. The number of functional turns may range from just over a half turn to five turns, or from one full turn to five turns, or more. In one embodiment with three full turns, an additional half turn is included in the ventricular portion of the docking device. In another embodiment, there may be a total of three full turns in the docking device. In one embodiment, there may be a half to three-quarters or half to three-quarters turn of turns in the atrial portion of the docking device. While a range of numbers of turns is provided, as the number of turns in the docking device decreases, the dimensions and / or material of the coil and / or the wire from which the coil is made may also vary to maintain adequate retention force. For example, the wire diameter may be larger and / or the diameter of the functional coil turns in a docking device having fewer coils. There may be multiple coils in the atrium and ventricle.

[0028] The size of the one or more functional coils of the central region 10 is generally selected based on the size of the desired THV to be implanted in a patient. Generally, the inner diameter of the functional coil turns (e.g., of the coil turns of the central region 10 of the docking device 1) will be smaller than the outer diameter of the expandable heart valve, resulting in a prosthetic valve that is larger than its outer diameter. When expanded within the docking device, additional radial tension or retention forces act between the docking device and the prosthetic valve to hold the prosthetic valve in place. The retention forces required for proper implantation of the prosthetic valve vary based on the size of the prosthetic valve and the ability of the assembly to handle mitral valve pressures of approximately 180 mmHg. For example, based on bench-top studies using prosthetic valves with an expanded outer diameter of 29 mm, a retention force of at least 18.5 N is required between the docking device and the prosthetic valve to securely hold the prosthetic valve within the docking device and resist or prevent mitral valve regurgitation or leakage. However, under this example, in order to meet this 18.5N retention force requirement with statistical confidence, the target average retention force should be substantially greater, for example, about 30N.

[0029] In many embodiments, the retention force between the docking device and the prosthetic valve is dramatically reduced when the difference between the outer diameter of the prosthetic valve in its expanded state and the inner diameter of the functional coil is less than about 5 mm, because the reduced size difference is too small to create sufficient retention force between the components. For example, as in one embodiment, when a prosthetic valve having an expanded outer diameter of 29 mm is expanded to a set of coils having an inner diameter of 24 mm, the retention force observed is about 30 N, but when expanded to a set of coils having an inner diameter of 25 mm (e.g., only 1 mm larger), the retention force observed drops significantly to only 20 N. Thus, for this type of valve and docking device, the inner diameter of the functional coil (e.g., the coil in the central region 10 of the docking device 1) should be 24 mm or less to create sufficient retention force between the docking device and the 29 mm prosthetic valve. In general, the inner diameter of the functional coil (e.g., the central region 10 of the docking device 1) should be selected to be at least about 5 mm smaller than the prosthetic valve selected for implantation. Various factors can affect retention, so better retention may be provided when other sizes or size ranges are used, e.g., using friction enhancing features, material properties, etc. Additionally, the size of the inner diameter of the functional coil or central region 10 may also be selected to bring the mitral valve anatomy closer together to at least partially counteract or negate mitral regurgitation caused by stretching of the native annulus, e.g., as a result of left ventricular enlargement.

[0030] It should be noted that the desired retention forces described above are applicable to embodiments of mitral valve replacement. Thus, other embodiments of the docking device used for replacement of other valves may have different size relationships based on the desired retention forces for the valve replacement in their respective locations. Additionally, the dimensional differences may vary based on, for example, the materials used in the valve and / or docking device, whether there are other features to prevent functional coil expansion or to enhance friction / locking, or various other factors.

[0031] In embodiments where the docking device 1 is used in the mitral valve position, the docking device may be first advanced to deliver to the native mitral annulus and then placed in the desired position prior to implantation of the THV. Preferably, the docking device 1 is flexible and / or made of a shape memory material so that the coil of the docking device 1 may be straightened for delivery via a transcatheter approach as well. In other embodiments, the coil may be made of other biocompatible materials, such as stainless steel. Some of the same catheters and other delivery tools may be used for both the docking device 1 and delivery of the prosthetic valve, without the need to perform separate preparation steps, simplifying the implantation process for the end user.

[0032] The docking device 1 can be delivered to the mitral valve location transcardially from the left atrium via the atrial septum, or can be delivered to the mitral valve location via one of a variety of other known access points or procedures. Figures 6 and 7 show several steps during delivery of the docking device 1 to the mitral valve location using a transcatheter approach, where a guide sheath 1000 is advanced through the vasculature into the right atrium and through the atrial septum of the heart into the left atrium. A delivery catheter 1010 is advanced through the guide sheath 1000 passing through the vasculature, the right atrium, and the septum into the left atrium. As can be best seen in Figure 6, the docking device 1 can be advanced through a distal tip of the delivery catheter 1010 positioned in the left atrium (e.g., positioned at the commissures), through the native mitral valve annulus, e.g., at the commissures of the native mitral valve, and into the left ventricle. The distal tip of docking device 1 then circles around the mitral valve anatomical structures (e.g., native mitral valve leaflets and / or chordae tendineae) located in the left ventricle, such that all or at least some of the native leaflets and / or chordae tendineae are held (e.g., surrounded) by the coil of docking device 1, which surrounds or gathers them together.

[0033] However, because the functional coil turn or coil turns of the central region 10 of the docking device 1 are kept at a relatively small diameter (e.g., the central region 10 in one embodiment may have an inner diameter of about 24 mm (e.g., ±2 mm) or another diameter smaller than the THV and / or native annulus), it may be difficult to advance the docking device 1 around the existing leaflets and / or chordae tendineae to a desired position relative to the native mitral annulus in order to increase the retention force with the prosthetic valve. This is especially true if the entire docking device 1 is made to have the same small diameter as the central region 10. Thus, referring again to FIGS. 3-5, the docking device 1 may have a distal or lower region 20 that constitutes it. The leading coil turn (or leading ventricular coil turn) of the docking device 1 has a diameter larger than the diameter of the functional coil turn or coil turns of the central region 10.

[0034] The mitral valve anatomical features in the left ventricle have variable dimensions and may have a maximum width of up to about 35 mm to 45 mm on the long axis. Thus, the diameter or width of the leading coil turn of the lower region 20 (e.g., ventricular coil turn) may be selected to be larger to more easily navigate the distal or leading tip 21 of the docking device 1 to encircle the mitral valve anatomical features (e.g., valve leaflets and / or chordae tendineae). Various sizes and shapes are possible, for example, in one embodiment, the diameter may be any size from 25 mm to 75 mm. The term "diameter" as used in this disclosure does not require that the coil turn be a perfect circle or a perfect shape circle, but is generally used to refer to the maximum width across opposing points of the coil turn. For example, for the leading coil turn, the diameter may be measured from the distal tip 21 to the opposite side as if the lower region 20 or leading coil turn formed a complete turn, or the diameter may be twice the radius of curvature of the leading coil / turn. In one embodiment, the lower region 20 (e.g., leading coil turn) of the docking device 1 may be approximately 43 mm (e.g., ±2 mm) in diameter (e.g.), in other words, the radius of curvature of the leading coil turn may be approximately 21.5 mm. Having a leading coil turn of a larger size than the functional coil may help to more easily guide the coil around and / or through the chordae tendineae shape and, most importantly, around both native leaflets of the mitral valve. As the distal tip 21 is navigated around the desired mitral valve anatomy, the remaining coils of the docking device 1 are also guided around the same features, where reducing the size of the other coils may slightly pull the surrounded anatomical features radially inward. Meanwhile, the length of the enlarged lower region 20 is generally kept relatively short to prevent or avoid obstruction or interference of blood flow along the left ventricular outflow tract by the lower region 20. For example, in one embodiment, the enlarged lower region 20 extends only about half a loop or turn.With the lower region 20 having this relatively short length, when the prosthetic valve is expanded into the docking device 1 and the coils of the docking device 1 begin to unwind slightly due to size differences between the docking device and the prosthetic valve, the lower region 20 may also be retracted and shifted slightly. In this example, after expansion of the prosthetic valve, the lower region 20 is similar in size and substantially aligned with the functional coils of the docking device 1, rather than continuing to protrude from the functional coils, thereby reducing potential flow obstruction. Other docking device embodiments may have longer or shorter lower regions depending on the particular application.

[0035] The docking device 1 of Figures 3-5 also includes an enlarged proximal or upper region 30 that constitutes a stabilizing coil turn (which may be, for example, an atrial coil turn) of the docking device 1. Once the docking device 1 is positioned in the desired position and orientation at the native mitral annulus, the entire docking device 1 is released from the delivery catheter 1010, after which the prosthetic valve (e.g., THV) is delivered to the docking device 1. During the transient or intermediate stages of the implantation procedure, i.e., the time between the deployment and release of the docking device 1 and the final delivery of the prosthetic valve, the coil may move and / or become dislodged from its desired position or orientation, for example, due to normal cardiac function. Moving the docking device 1 may potentially result in a less secure implantation, malalignment, and / or other positioning issues of the prosthetic valve. A stabilizing mechanism or coil may be used to help stabilize the docking device in the desired position. For example, the docking device 1 may include an upper region 30 having an enlarged stabilizing coil turn (e.g., an enlarged atrial coil turn) intended to be placed within the circulatory system (e.g., within the left atrium) to be able to stabilize the docking device. For example, to improve the ability of the docking device 1, the upper region 30 or the stabilizing coil turn may be configured to abut or press against the wall of the circulatory system (e.g., against the wall of the left atrium) to remain in its desired position prior to implantation of the prosthetic valve.

[0036] The stabilizing coil turns (e.g., atrial coil turns) in the upper region 30 of the docking device 1 in the illustrated embodiment extend for about one or nearly one full turn or rotation and terminate at a proximal tip 31. In other embodiments, the stabilizing coil turns (e.g., atrial coils) may have more or less than one rotation, depending, for example, on the desired amount of contact between the docking device and the circulatory system in each particular application (e.g., with the wall of the left atrium). The radial size of the stabilizing coil turns (e.g., atrial coils) in the upper region 30 may also be significantly larger than the size of the functional coils in the central region 10, such that the stabilizing coil turns (e.g., atrial coils) splay or expand outwardly sufficiently to contact the wall of the circulatory system (e.g., the wall of the left atrium). For example, in one embodiment, the outer diameter 32 or width of the upper region 30 is about 50 mm (e.g., ±2 mm), or about twice as large as the coils in the central region 10. The bottom region of the left atrium generally narrows toward the native mitral valve annulus. Thus, when the docking device 1 is properly deployed in the mitral valve position, the stabilizing coil turns (e.g., atrial coils) of the upper region 30 seat and press against the wall of the left atrium, helping to maintain or hold the docking device 1 in a relatively high desired position and orientation, preventing or reducing the docking device 1 from migrating toward the left ventricle until the THV is advanced into and expanded within the docking device 1. When the prosthetic valve (e.g., THV) is expanded within the docking device, the forces generated between the functional coils and the prosthetic valve (e.g., with tissue, leaflets, etc. between them) are sufficient to secure and stabilize the docking device and prosthetic valve without the need for stabilizing coil turns.

[0037] Optionally, the stabilizing coil turns (e.g., atrial coils) of the upper region 30 can be non-circular in shape and, in the illustrated embodiment, are arranged with an elliptical or oval bias. As shown in FIG. 5, the elliptical or other non-circular shaped stabilizing coil turns (e.g., atrial coils) can have a major axis diameter 32, D1 (i.e., maximum width of the coil turn) and a minor axis diameter 33, D2 (i.e., minimum width from end to end). The width / diameter can be selected based on the size of the anatomical structure of the portion of the circulatory system (e.g., based on the size of the left atrium in humans). The major axis diameter (or maximum width) D1 can be in the range of 40-100 mm, or 40-80 mm, or 40-75 mm. The minor axis diameter (or minimum width) D2 can be in the range of 20-80 mm, or 20-75 mm. The major axis / width D1 of the stabilizing coil turn (e.g., atrial coil) may be about 50 mm, while the diameter / width D2 along the minor axis of the stabilizing coil turn (e.g., atrial coil) may be much smaller, e.g., only slightly larger than the diameter of the central region 10 of the docking device 1, as best seen in the top view of the docking device 1 in FIG. 5. In other embodiments, the offset of the upper region of the docking device may be achieved in other ways. For example, the stabilizing coil turn (e.g., atrial coil) of the upper region 30 may still be substantially circular, and / or the stabilizing coil turn may be offset in one direction to offset the center of the upper region from the center of the rest of the docking device. This offset of the shape of the upper region 30 of the docking device 1 may increase the contact between the docking device 1 and the wall of the left atrium or other anatomical structure, e.g., in the radial direction in which the upper region 30 extends furthest from the rest of the docking device 1. The stabilizing coil turn (e.g., atrial coil) may be biased such that, when viewed from a bird's-eye view (FIG. 20), the stabilizing coil turn (e.g., atrial coil) has a center that is offset from the center of the functional coil by about 50-75% of the diameter of the functional turn. The stabilizing turn (e.g., atrial turn) of the coil may be compliant and bow inward.This accommodates anatomical structures (e.g., left atrial anatomy) where the stabilizing coil turns (e.g., atrial coils) may have larger long or short axis diameters than the atrium or other anatomical structure itself.

[0038] Importantly, the docking device 1 can be rotated or otherwise oriented such that the narrower portion of the upper region 30, or the portion that extends least radially outward, is oriented in an optimal manner. For example, when implanted on a native mitral valve, the amount of pressure exerted by the docking device 1 against that portion of the atrial wall, toward the wall of the left atrium that opposes or pushes against the left ventricular outflow tract, is reduced. In this way, the amount of displacement of that portion of the wall into the left ventricular outflow tract is also reduced, and thus the enlarged upper region 30 can avoid obstructing, interfering with, or otherwise affecting blood flow through the left ventricular outflow tract.

[0039] With the enlarged upper region 30, the docking device 1 may be more securely held or maintained in proper positioning and orientation against the native valve annulus (e.g., the native mitral annulus) before the THV is implanted and expanded. Such self-retention of the docking device 1 more effectively prevents undesired movement or tilting of the docking device 1 before the prosthetic valve is fully implanted, thereby improving the performance of the overall implant.

[0040] 6-9 show some of the steps that can be used to deliver and implant a docking device (e.g., docking device 1 or other docking devices described elsewhere herein) and a THV into the mitral valve position. Although they focus on the mitral valve position, similar steps can be used in other valve positions, e.g., the tricuspid valve position. The docking device can be docking device 1 described above with respect to FIGS. 3-5 or another similar docking device (e.g., other docking devices herein), and the THV is generally a self-expanding, mechanically expandable, or balloon expandable THV (or combinations thereof) having a circular or cylindrical valve frame or stent sized to be expanded and retained within the docking device.

[0041] 6 and 7 illustrate a transseptal procedure for delivering the docking device 1 to the mitral valve position of a patient, in which a guide sheath / introducer 1000 is advanced across the atrial septum of the heart, and a distal tip of a delivery catheter 1010 is advanced through the guide sheath 1000 and positioned such that the distal opening of the delivery catheter is located within the left atrium for delivery of the docking device 1. Optionally, the delivery catheter may be similarly advanced through the anatomy (e.g., vasculature, heart chambers, septum, etc.) and similarly positioned without first inserting or using a guide sheath. In an exemplary procedure, the guide sheath 1000 (and / or delivery catheter 1010) is introduced into the patient's venous system, for example, by a percutaneous puncture or small surgical cut in the patient's groin, and then the guide sheath 1000 (and / or 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 only one example, and that various alternative procedures and / or access sites may instead be used to place the docking device 1 and / or a suitable prosthetic valve at the mitral valve location or other cardiac locations. However, such a procedure may provide a cleaner entry into the left side of the heart when compared to, for example, a transapical procedure or other procedures in which access to the mitral valve is via the left ventricle, allowing the physician to avoid direct interference with chordae tendineae or other ventricular obstructions.

[0042] As shown in FIG. 6, the delivery catheter 1010 is advanced to a position in the left atrium where the distal tip of the delivery catheter 1010 is directly above the plane of the native valve (e.g., the mitral plane), e.g., may be positioned near the commissures of the native valve. The delivery catheter may be steerable in multiple dimensions (e.g., two or more dimensions) to allow for more precise positioning. The positioning of the distal opening of the delivery catheter defines an access site for implanting the docking device 1 at the mitral valve position. The access site is usually near one of the two commissures of the native mitral valve, such that the distal tip 21 of the docking device 1 can be advanced through the native valve commissures and into the left ventricle to position the leading coil turn of the lower region 20, as well as at least a portion of the functional coil (e.g., the coil of the middle region 10), within the left ventricle. In one placement method, the distal tip 21 of the docking device 1 first passes through the commissure A3P3 of the native mitral valve, and then more of the docking device 1 is advanced from the delivery catheter through the commissure A3P3.

[0043] While the docking device 1 is held within the delivery catheter 1010, the docking device 1 may be straightened to be more easily manipulated through the delivery catheter 1010. When the docking device 1 is then rotated, pushed, or otherwise advanced out of the delivery catheter 1010, the docking device 1 may return to its original coiled or curved shape, and further advancement of the docking device 1 out of the delivery catheter may cause clockwise or counterclockwise (i.e., looking at the annulus in the direction of blood outflow) advancement of the distal tip 21 around (e.g., encircling) various mitral valve anatomical structures, based on the curved direction of the docking device 1 as it exits the delivery catheter. The enlarged leading coil turn (e.g., ventricular coil turn) in the lower region 20 of the docking device 1 may make it easier to navigate the distal tip 21 of the docking device 1 around the mitral valve anatomical structures of the left ventricle. In the above example, when the distal tip 21 of the docking device 1 enters the left ventricle through the commissure A3P3 and advances clockwise while looking at the annulus in the outflow direction (e.g., from the atrium to the ventricle), the docking device 1 can move around first and encircle the posterior leaflet of the native mitral valve. Alternative methods for encircling the posterior leaflet first are also available, for example, by inserting the distal tip 21 through the commissure A1P1 and then advancing the docking device counterclockwise.

[0044] In some circumstances, it may be easier to encircle the posterior leaflet of the native mitral valve first than the anterior leaflet first because the posterior leaflet is positioned closer to the ventricular wall, which provides a more constricted space through which the distal tip 21 can be advanced. Thus, the distal tip 21 of the docking device 1 may use the ventricular wall near the posterior leaflet as a path or guide for advancement around the posterior leaflet. Conversely, when advancing the distal tip 21 of the docking device 1 to attempt to capture the anterior leaflet of the native mitral valve, there is no nearby ventricular wall that can facilitate or guide advancement of the distal tip 21 in that direction. Thus, in some circumstances, it may be more difficult to properly begin encircling the mitral valve anatomy when navigating the distal tip 21 to attempt to capture the anterior leaflet first instead of the posterior leaflet.

[0045] Nevertheless, it may be preferential or necessary in some procedures to corral the anterior leaflet first. Furthermore, in many circumstances, it may also be much easier to bend the distal tip of the delivery catheter 1010 in a counterclockwise direction in preparation for delivery of the docking device. Thus, the delivery method of the docking device may be adjusted accordingly. For example, the docking device may be configured to turn the coil in the opposite, counterclockwise direction (e.g., as seen in FIG. 10 below), where the delivery catheter 1010 also winds in a counterclockwise direction. In this way, such a docking device may be advanced, for example, through the commissure A3P3 and into the left ventricle in a counterclockwise direction looking at the annulus in the outflow direction (e.g., from the atrium to the ventricle) rather than in the clockwise direction described above.

[0046] The amount of docking device advanced into the left ventricle depends on the particular application or procedure. In one embodiment, the coils of the lower region 20 and most (if not all) of the coils of the middle region 10 are advanced and positioned in the left ventricle. In one embodiment, all of the coils of the middle region 10 are advanced into the left ventricle. In one embodiment, the docking device 1 is advanced to a position where the distal tip 21 is located behind the anterior medial papillary muscle. This position provides a more secure anchoring of the distal tip 21, and thus the entire docking device 1, as the distal tip 21 is seated and held between the chordae tendineae in that region and the ventricular wall. On the other hand, once any portion of the mitral valve anatomy is enclosed and / or captured by the distal tip 21, further advancement of the docking device 1 serves to gather the captured chordae tendineae and / or leaflets within the coils of the docking device 1. Both stable positioning of the distal tip 21 and retention of the native mitral valve anatomy by the docking device 1 may help to prevent obstruction of the left ventricular outflow tract (e.g., of the aortic valve) prior to implantation of the THV.

[0047] After a desired amount of the docking device 1 has been advanced into the left ventricle, the remaining docking device 1 is deployed or released into the left atrium. FIG. 7 illustrates one method of releasing the atrial portion of the docking device 1 into the left atrium. In FIG. 7, the distal tip of the delivery catheter 1010 is rotated back 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, once the docking device 1 has been advanced clockwise through the commissure A3P3, the distal tip of the delivery catheter 1010 can then be rotated counterclockwise or retracted to release the atrial portion of the docking device 1. Various other methods of releasing the atrial portion of the docking device 1 can also be employed. Before the stabilizing coil turn (e.g., atrial coil) is released from the delivery catheter, it can be held in place and / or retracted / retrieved by a retention device / anchor (e.g., by hooking onto the release suture, Velcro, latch, lock, anchor that can be screwed onto the delivery device, etc.). Once released, the docking device is not tightly engaged with the native mitral valve (i.e., it is only loosely positioned around the native mitral valve leaflets).

[0048] After the docking device 1 is fully deployed and adjusted to a desired position and orientation, the delivery catheter 1010 can be removed to make room for a separate delivery catheter for delivering the THV, which in some embodiments can be adjusted and / or repositioned if the prosthetic valve is to be delivered through the same catheter 1010. Optionally, after the delivery catheter 1010 is removed, the guide sheath 1000 can be left in place and a prosthetic valve or THV delivery catheter can be inserted and advanced through the same guide sheath 1000. FIG. 8 shows a cross-sectional view of a portion of a patient's heart with the docking device 1 of FIGS. 3-5 positioned in the mitral valve position and prior to delivery of the THV. Here, the enlarged upper region 30 of the docking device 1 can press against the atrial wall to help hold the docking device 1 in a desired orientation, and as described above, the bias of the upper region 30 can be adjusted so that the upper region 30 does not press against the wall which could cause obstruction of the left ventricular outflow tract.

[0049] It is further noted that in at least some procedures, once the docking device 1 is delivered to the mitral valve position as described above, the leaflets are not substantially restrained by the docking station prior to implanting the prosthetic valve therein, allowing the native mitral valve to operate substantially normally and the patient to remain stable. Thus, the procedure may be performed on a beating heart without the need for a heart-lung machine. Furthermore, this allows the physician greater flexibility in terms of the time to implant the prosthetic valve, without the risk of the patient getting into or falling into a hemodynamic compromise position if too much time is allowed between implantation of the docking device 1 and subsequent implantation of the valve.

[0050] FIG. 9 shows a cross-sectional view of a portion of the heart with both the docking device 1 and the prosthetic valve 40 (e.g., THV) finally implanted in the mitral position. Generally, the prosthetic valve 40 has an expandable frame structure 41 that houses multiple valve leaflets 42. The expandable frame 41 of the prosthetic valve 40 may be balloon expandable or may be otherwise expandable, for example, the frame is self-expanding, mechanically expandable, or expandable in a combination of various ways. The prosthetic valve 40 may be delivered through the same catheter 1010 used to deliver the docking device 1, or may be introduced through a separate catheter, generally while the valve 40 is radially collapsed for easier navigation. Optionally, the guide sheath may be left in place when the catheter 1010 is removed, and a new prosthetic valve or THV delivery catheter may be advanced through the guide sheath 1000. The prosthetic valve 40 can then be advanced from the delivery catheter and placed through the docking device 1 while still in a collapsed configuration, and then expanded within the docking device 1, whereby radial pressure or tension between the components holds the entire assembly securely in position at the mitral valve. The mitral valve leaflets (or portions of the mitral valve leaflets) may be sandwiched between the functional turns of the docking coil and the frame of the prosthetic valve 41. After the docking device and prosthetic valve are securely deployed / implanted, the remaining delivery tools can be removed from the patient.

[0051] FIG. 10 shows a perspective view of an improved version of the coiled anchor or docking device 1 of FIGS. 3-5. The docking device 100 of FIG. 10 has a central region 110, a lower region 120, and an upper region 130, which are the same as or similar to the central region 10, the lower region 20, and the upper region 30, respectively, of the docking device 1 described above. The docking device 100 can include features and characteristics similar to those described with respect to the docking device 1, and can be implanted using similar 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 be disposed, for example, across the central region 110 (e.g., above the central region 1110) or across the upper region 130. 10, extension 140 is comprised of or includes a vertical portion of a coil that extends substantially parallel to the central axis of docking device 100. In some embodiments, extension 140 can be angled relative to the central axis of docking device 100, but generally serves as a vertical or axial spacer that vertically or axially spaces adjacent connecting portions of docking device 100. As a result, a vertical or axial gap is formed between the coil portions on either side of extension 140 (e.g., a gap may be formed between the upper or atrial side and the lower or ventricular side of docking device 100).

[0052] The extension 140 of the docking device 100 is intended to be positioned through (e.g., crossing) or near the native annulus to reduce the amount of the docking device 100 passing through or resting against the native annulus when the docking device 100 is implanted. This may potentially reduce stress or strain on the native mitral valve by the docking device 100. In one configuration, the extension 140 is positioned through or crosses one of the commissures of the native mitral valve. In this manner, the extension 140 may position the upper region 130 away from the native mitral valve leaflets to prevent interaction or engagement with the native leaflets from the atrial side of the upper region 130. The extension 140 may also raise the position of the upper region 130 and thus raise or space the contact that the upper region 130 makes against the atrial wall further away from the native valve, which may, for example, reduce stress at and around the native valve and may more securely hold the position of the docking device 100. The extension 140 may have a length in the range of 5-100 mm, and in one embodiment is 15 mm.

[0053] The docking device 100 may further include one or more through holes 150 at or near one or both of the proximal and distal tips of the docking device 100. The through holes 150 may function, for example, as suture holes for securing and / or as attachment sites for delivery tools, such as pull wires / sutures for pushers, retention devices / anchors (e.g., to hold the docking device and / or to allow for retraction and retrievability of the device after it has been fully or partially deployed from the delivery catheter), or other advancement or retention devices, for example, a cover layer over the coil of the docking device 100. In some embodiments, the width or thickness of the coil of the docking device 100 may also vary along the length of the docking device 100. For example, the central region of the docking device 100 may be slightly thinner than the end regions (not shown) of the docking device 100. Thereby, for example, the central region may exhibit greater flexibility and the end regions may be stronger or more rigid, and / or the end regions may provide a greater surface area for sewing or otherwise attaching the cover layer to the coil of the docking device 100, among other reasons. In one embodiment, all or a portion of the extension 140 may have a thickness that is less than the thickness of other regions of the docking device, e.g., the extension 140 may be thinner than the preceding coil turn or lower region 120, which may be thinner than the functional coil turn or central region 110, and / or the stabilizing coil turn or upper region 130, as shown in FIG.

[0054] In FIG. 10 (and likewise FIG. 19), the coil of docking device 100 is depicted as turning in the opposite direction to the coil of docking device 1 described above. Thus, as shown, docking device 100 is configured to be inserted through the native annulus in a counterclockwise direction looking at the annulus in the direction of blood outflow (e.g., from the atrium to the ventricle). This advancement can be made through commissure A3P3, commissure A1P1, or through another portion of the native mitral valve. Placement of docking device 100 in a counterclockwise direction also allows for bending the distal tip of the delivery catheter in a similar counterclockwise direction, which is often easier to accomplish than bending the delivery catheter in a clockwise direction. The various coiled docking device embodiments described herein (including docking devices 1, 100, 200, 300, 400, 500, 600, 1100) can be configured to advance in a clockwise or counterclockwise direction through one of a variety of access points (e.g., either commissure).

[0055] In most situations and patients, the docking device should be placed high relative to the native mitral valve (e.g., more into the left atrium). When considering the mitral valve anatomy, the final implanted dock-valve combination should be placed high on the native valve and, in some cases, the valve should be secured as high as possible to a distinct region of the native mitral valve leaflets. In addition, in healthy human hearts, the native mitral valve leaflets are generally smooth above the coaptation line (e.g., above where the leaflets meet when the mitral valve is closed) and rougher below the coaptation line. The smoother regions or areas of the native leaflets are much more collagenous and stronger, thereby providing a more secure anchoring surface for the prosthetic valve than the rougher regions or areas. Thus, in most cases, the docking device should be placed as high as possible on the native valve during insertion, while also having sufficient retention to secure the prosthetic valve or THV. For example, the length of the coil in the docking device placed in the ventricle generally depends on the number of turns in the ventricle and the thickness of the wire used. In general, the thinner the wire used, the longer the length is needed in the ventricle to provide sufficient retention. For example, if the docking device coil has a length of 370 mm, approximately 280 mm (e.g., ± 2 mm) would be placed in the ventricle. Approximately 70-90 mm would be placed in the atrium, and approximately 10-15 mm would be used for the transition or extension length to move the docking device coil away from the plane of the mitral valve on the atrial side of the docking device.

[0056] 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 as well as the typically smaller size of replacement valves, an inverse relationship is formed between how high a docking device can be positioned in the mitral valve position and the retention force with which the docking device allows a THV to be implanted within it. Docking devices with a larger diameter can capture more chordae tendineae within them, and therefore have the ability to deploy higher compared to the native valve, but provide a lesser amount of retention force to the valve docked to them. Conversely, docking devices with a smaller diameter may provide a stronger retention force to the docked valve, but may not be able to wrap around and capture as many chordae tendineae during positioning, resulting in lower positioning of the docking device at the native annulus. On the other hand, larger docking devices may be improved such that they have increased coil diameters or thicknesses and / or can be constructed using materials with higher elastic moduli.

[0057] 11-13 show a docking device according to another embodiment of the present invention. The docking device 200 (see FIGS. 12 and 13) is formed with 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 placed in the native annulus, and can then be adjusted with the wire 219 to assume a smaller or narrower configuration in preparation for docking a prosthetic valve.

[0058] FIG. 11 shows a schematic of an open sheet of laser cut tubes 210, for example, the ends of which can be connected to form a tubular structure, or a similar tube can be formed as a tube without a seam and cut as a tube. The tubes 210 can be made from either shape memory or non-shape memory materials (e.g., NiTi, stainless steel, other materials, or combinations of materials). The tubes 210 are laser cut in the pattern shown in FIG. 11 or a similar pattern, with the cut pattern determining the shape of the docking device 200 when it is actuated. The patterned cuts in FIG. 11 include a plurality of separate cuts 211 that extend transversely to the longitudinal axis of the tube 210 and separate the tube 210 into a plurality of interconnecting links 212. Each cut 211 further forms one or more teeth 213 and one or more corresponding grooves 214 in the adjacent link 212, such that the teeth 213 may extend into the adjacent grooves 214, including when the tube 210 is bent or curved. The teeth 213 and grooves 214 formed by each cut 211 may be configured to extend in the same direction or in opposite directions along the tube 210, depending on the desired shape of the docking device 200. The cuts 211 are also completely contained on the sheet or tube, in other words the cuts 211 do not extend to any of the edges of the tube sheet or tube, so that the links 212 remain interconnected to one another in at least one region. In other embodiments, some or all of the cuts may extend to the edges of the sheet or tube, as desired. In the embodiment of FIG. 11, each of the cuts 211 further includes end regions 215 at either end of the cut 211 that extend parallel to the longitudinal axis of the tube 210. The end regions 215 provide space for adjacent links 212 to pivot relative to one another while remaining interconnected.

[0059] The laser cut patterning may also be modified or changed along the length of the tube 210, with cuts having different sizes, shapes, and positioning on the sheet or tube to effect different shapes and curvatures in the docking device 200 when the docking device 200 is pulled or actuated. For example, as seen in FIG. 11, the left end of the sheet or tube includes another cut 216 that is larger than the cut 211 seen in the central and right portions of the sheet or tube (as shown). As will be described in more detail below, the left end of the tube 210 may have such an enlarged laser cut pattern to effect greater mobility or flexibility of the distal tip of the docking device 200.

[0060] Additionally, the laser cut sheet or tube may have one or more distal wire locking mechanisms, e.g., cut 217 at the distal or left end of the sheet or tube as shown, and / or one or more proximal wire locking mechanisms, e.g., cut 218 at the proximal or right end of the sheet or tube as shown. Using either or both of the distal 217 or proximal 218 wire locking mechanisms, a locking wire 219, shown in FIG. 11A, may be attached to the distal or proximal end of the tube 210 and then pulled through the tube 210 and locked to the opposite end of the tube 210 to achieve a desired actuated shape of the docking device 200. When the locking wire 219 is attached to one end of the tube 210 and then actuated and locked to the other end of the tube 210, by positioning the laser cut pattern along most or the entire length of the tube 210, the placement of the cuts 211, 216 forces the tube 210 into a desired final coiled shape or configuration. The tension of the tension wire has the ability to control the radial outward and inward forces applied to the docking device 200 and the force applied by the docking device 200 on other features, such as the replacement valve 40 held therein. The locking wire can help control the force applied by the docking device, but in other embodiments, the locking wire is not required. The locking wire can be in a laser cut hypotube, or the locking wire can be in a tube that is not laser cut. The locking wire can be a suture, tether, wire, strip, etc., and the locking wire can be made of a variety of materials, such as metal, steel, NiTi, polymer, fiber, Dyneema, other biocompatible materials, etc.

[0061] In some embodiments, such as those using a shape memory material such as NiTi to construct the docking device 200, the tube 210 may be placed around a circular mandrel that defines the desired coil diameter during fabrication and shape setting, and the shape set at that particular diameter. The shape set diameter may in some embodiments be larger than the desired final diameter of the docking device 200, such that the tube 210 assumes a larger shape set diameter as it is pushed out of the delivery catheter before the locking or tension wires are actuated. During this time, the larger diameter of the docking device 200 may help the docking device 200 to more easily navigate and encircle the anatomical shape of the native valve.

[0062] Additionally, in some embodiments, the distal tip 222 of the tube 210 can be configured with a different shape so that, instead of following the same coil shape as the rest of the docking device 200, the distal tip 222 bends or articulates slightly radially compared to the rest of the docking device 200 to further aid in encircling the mitral or other valvular anatomy, as seen, for example, in FIG. 12. As discussed above, in addition to or in lieu of a different shape setting, the distal tip 222 of the tube 210 can include different cuts 216 to make the distal tip 222 more flexible or mobile, which can also aid in navigation of the distal tip 222 of the docking device 200 around the anatomy.

[0063] After the docking device 200 has been maneuvered around the mitral valve anatomy or other anatomical geometry and reaches a desired position relative to the native valve, the locking wires can be pulled or actuated to reduce the size of the docking device (e.g., to reduce the diameter of the coil turns) in preparation for tighter or more secure docking of the prosthetic replacement valve 40. On the other hand, in some embodiments in which the distal tip 222 of the docking device 200 is shape set to bend outward, tension in the locking wires can pull or draw the distal tip 222 further inward so that the distal tip 222 more closely matches the shape of the rest of the docking device 200 to more effectively contribute to docking of the replacement valve 40.

[0064] The replacement valve 40 may then be positioned within the docking device 200 and expanded. FIG. 13 is an example of the docking device 200 after it has been actuated by the locking wires and after the replacement valve 40 has been expanded therein. The tension of the locking wires more effectively holds the desired shape and size of the docking device 200 and helps maintain a stronger retention force between the docking device 200 and the valve 40. The radially outward pressure exerted by the valve 40 on the docking device 200 is countered by the radially inward pressure exerted on the valve 40 by the tension or locking wires and docking device 200, creating a stronger and more secure retention between the parts. Further, as can be seen in FIG. 13, the docking device 200 is able to retain its shape and size more effectively, as radially inward pressure from the docking device 200 onto the valve 40 can create a flaring effect at the ends of the valve frame, thereby providing an even more secure retention between the docking device 200 and the valve 40.

[0065] Docking device 200 may be modified in various ways in other embodiments. For example, the docking device may be made from or include a shape memory material other than NiTi, or, in some embodiments, may be made from a non-shape memory material, such as stainless steel, other biocompatible materials, and / or combinations thereof. In addition, while docking device 200 is described above for use with the mitral valve, in other applications, a similar or slightly modified docking device may be used to dock replacement valves at other native valve sites, such as the tricuspid, pulmonary, or aortic valves.

[0066] The docking device 200 described above, and similar devices that use tension or locking wires, may provide several advantages over other docking devices, such as those in which locking wires are not used. For example, the locking wires provide the user with the ability to control the amount of radial outward and inward force exerted on and by the docking device by tensioning and adjusting the locking wires without compromising the desired profile of the docking device or the ability to deliver the docking device through a catheter or via minimally invasive techniques. FIG. 11A shows a tension wire 219 that is held under or looped around the tines 218 and then pulled through and corrugated at the openings 217 to set the shape of the docking device. Additionally, the laser cut in the tube makes the docking device more flexible, allowing the docking device to be introduced through a catheter that may have a relatively small bend radius at certain locations.

[0067] In embodiments where a shape memory material is used, the docking device may be shaped into a coil with a larger diameter so that it may more easily encircle anatomical features during delivery of the docking device and before the locking wire is pulled. Additionally, the distal tip of the docking device may be further shaped to contract or bias slightly outward to help encircle even more of the anatomical shape during advancement and positioning of the docking device. Additionally, in some embodiments, the distal tip of the docking device may be further refined, for example, to remove more material to form a larger cut, making the distal tip of the docking device even more flexible, so that the tip is more easily actuated and manipulated, and more effectively navigates and encircles different cardiovascular anatomical structures. Patterns may be laser cut to reduce forces in some areas more than others. The tube may be oval, i.e., the cross section of the tube may be oval, so that forces may cause the tube to curve in a desired direction. Tension wires may also be tightened at both the proximal and distal tips of the tube to provide tension forces. Although an exemplary cut pattern is shown, other cut patterns are possible.

[0068] One or more of the docking devices described herein (e.g., docking devices 1, 100, 200, 300, 400, 500, 600, and 1100 herein) may further incorporate or have added various mechanisms to increase the retention force between the docking device and a replacement valve expanded therein. Generally, a coil-shaped docking device has two open or free ends after implantation. When a THV or other replacement valve is expanded within the coil, the coil may partially unwind and increase in diameter due to the outward pressure exerted on the coil by the expanding valve, which in turn reduces the retention force exerted on the valve by the coil. Thus, mechanisms or other features may be incorporated into the docking device to prevent or reduce unwinding of the coil when a replacement valve is expanded therein, thereby increasing the radial and retention force between the docking device and the valve. Such features may be incorporated in lieu of modifying the size and shape of the docking device, for example by thickening the coil or reducing the diameter of the interior space formed by the coil, neither of which negatively impacts the performance or ease of delivery of the docking device. For example, making the docking device coil itself thicker would result in a stiffer coil as the thickness increases, making it more difficult to thread the docking device into a delivery catheter. On the other hand, if the diameter of the interior space formed by the coil becomes too small, the reduced space may prevent the inflatable valve from fully inflating.

[0069] A first alternative variation for ensuring sufficient retention between the docking device and the valve expanded within the docking device is shown in FIG. 14. The docking device 300 of FIG. 14 includes a main coil 310 (which may be similar in size and shape to one of the docking devices described above) and anchors 320 extending from two free ends of the coil 310. The anchors 320 are sized, shaped, or otherwise configured to be embedded in the surrounding tissue (e.g., the atrial and / or ventricular walls). The anchors 320 may be barbed to promote ingrowth once embedded in the heart wall or other tissue. The anchors may be any of many different shapes and sizes. The anchors may extend from any area from or near the ends. Optionally, the anchors or barbs may also be positioned at various locations along the length and exterior surface of the docking device.

[0070] In operation, when the docking device 300 is deployed in the mitral valve anatomy, one end of the docking device 300 is located in the left atrium and the other end of the docking device 300 is located in the left ventricle when the docking device 300 is positioned through the mitral valve. The shape and size of the coil 310 of the docking device 300 may be selected and optimized to ensure that the ends of the coil 310 abut against the atrial and ventricular walls, respectively, when the docking device 300 is advanced to a desired position. Thus, the anchors 320 at the ends of the coil 310 may themselves be anchored to the respective heart walls. 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 that are anchored to the heart walls. The inability of the free end of coil 310 to move when the replacement valve is expanded within docking device 300 prevents coil 310 from unwinding, thereby increasing the radial force applied between docking device 300 and the expanded valve and improving the retention force between the components.

[0071] FIG. 15 shows a schematic diagram of a portion of another improved docking device for improving the retention between the docking device and the replacement valve. A three-turn portion of a docking device 400 is shown in FIG. 15. The docking device 400 includes a main coil or core 410, which may be, for example, a NiTi coil / core, or may include a coil / core made of or including one or more of a variety of other biocompatible materials. The docking device 400 further includes a cover 420 that covers the coil / core 410. The cover 420 may be made of or include a high friction material such that when an expandable valve is expanded within the docking device 400, increased friction is created between the valve and the cover 420 to hold the shape of the docking device and prevent or inhibit / prevent the docking device 400 from unraveling. The cover may also, alternatively, increase friction between the docking device and the native valve leaflets and / or prosthetic valve, helping to maintain the relative positions of the docking device, valve leaflets, and / or prosthetic valve.

[0072] The cover 420 is made from one or more high friction materials disposed over the coil wire 410. In one embodiment, the cover 420 is made from or includes a PET braid covering an ePTFE tube. The ePTFE tube core is porous to provide a cushioned, padded type layer to bite into the struts or other parts of the frame of the expandable valve, improving engagement between the valve and the docking device 400. Meanwhile, the PET layer provides additional friction against the native leaflets as the prosthetic valve is expanded and the struts or other parts of the valve frame exert outward pressure on the docking device 400. These features cooperate to increase the radial force between the docking device 400 and the native leaflets and / or prosthetic valve, thereby increasing retention and may prevent the docking device 400 from unraveling.

[0073] In other embodiments, the cover 420 may be made from one or more other high friction materials that cover the coil 410 in a similar manner. The one or more materials selected to fabricate the cover 420 may also promote rapid tissue ingrowth. Additionally, in some embodiments, the outer surface of the replacement valve frame may also be covered with a fabric material or other high friction material to further increase the frictional forces between the docking device and the valve, thereby further reducing or preventing the docking device from unwinding. The friction provided by the cover may be provided with a coefficient of friction greater than 1. The cover may be made from ePTFE and may be a tube that covers the coil, and may be smooth or may have holes (or may provide a larger accessible surface area, such as pores, or may be biased or have other structural features) to promote tissue ingrowth. When the ePTFE tube is smooth, the cover may have a PET braid covering the ePTFE tube. The outermost surface of the cover or the braid on the cover may be any biocompatible material that provides friction, such as a biocompatible metal, silicone tubing, or PET. The pore size of the cover may range from 30 to 100 microns. In embodiments with a PET cover over the ePTFE, the PET layer is only attached to the ePTFE cover and not directly to the coil of the docking device. The ePTFE tube cover can be attached to the coil of the docking device at the proximal and distal tips of the cover. It can be laser welded to the coil, or radiopaque markers can be placed on the outside of the ePTFE tube cover or PET braid and swaged into the material to hold them in place relative to the coil.

[0074] While in some embodiments docking device 400 may include anchors similar to anchors 320 described above to further increase retention force, other embodiments of the docking device may incorporate cover 420 without further including such additional end anchors. As the replacement valve is expanded within docking device 400 and the resulting assembly begins to function as a composite functional unit, tissue ingrowth may also act to reduce stress on the composite valve and dock assembly.

[0075] The cover 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 cover can be configured to cover the functional coil, the leading coil, the stabilizing coil, or only a portion of one or more of these (e.g., only a portion of the functional coil).

[0076] 16 and 16A are schematic illustrations of a portion of yet another improved docking device that improves retention between the docking device and the replacement valve. As shown in the cross-sectional view of FIG. 16A, the leaflet tissue 42 is undulated to conform to a cross-section that changes between areas of the coil 510 that have friction elements 510 and areas of the coil 510 that do not have friction elements 510. This undulation of the leaflet tissue 42 results in more secure capture of the tissue 42 between the docking device 1 and the valve frame 41. The docking device 500 of FIG. 16 includes a main coil 510 and one or more separate friction elements 520 spaced along the length of the coil 510. The friction elements 520 may be made of a cloth material or other high friction material such as PET and formed as small bulges on the surface of the coil 510 or on another layer that is placed on the coil 510. In some embodiments, the cover 420 may itself be considered a friction element or may be configured to form one or more friction elements 520. In some embodiments, the friction element 520 is added in addition to adding a high friction cover 530 similar to cover 420 described above. One example of a docking device 500 having both a high friction cover 530 and a friction element 520 applied over a main coil 510 is shown generally in FIG.

[0077] When the expandable valve is expanded within the docking device 500, friction is created between the valve frame and the friction elements 520 and / or between the valve frame and the native leaflets and the docking device to prevent or inhibit / resist the coil 510 of the docking device 500 from unwinding. For example, the friction elements 520 can engage or otherwise extend into the cells defined by the frame of the expandable valve and / or can press the leaflet tissue into the cells of the expandable valve. Additionally, when the valve is expanded within the docking device 500, each of the friction elements 520 can engage with adjacent turns of the docking device 500 above and / or below the friction elements 520, and / or with one or more other friction elements. Any or all of such engagements can cause the docking device 500 to inhibit or resist unwinding, thereby increasing the holding force between the docking device 500 and the expanded valve.

[0078] FIG. 18 illustrates generally a portion of three turns of yet another improved docking device 600 that helps improve retention between the docking device and the replacement valve. The docking device 600 includes a coil 610 that is modified with one or more interlocking lock and key patterns spaced along the length of the coil 610. The lock and key pattern may be simple, such as a rectangular groove or notch 618 and a complementary rectangular protrusion 622, as generally shown in FIG. 18, or may be made of or include different shapes and / or more complex patterns in other embodiments. Additionally, the grooves 618 and protrusions 622 may all be positioned in the same axial direction or different axial directions in various embodiments. The lock and key patterns or other frictional elements may be positioned on the functional turns of the docking device.

[0079] When the expandable valve is expanded within the docking device 600, the lock and key mechanism relies on adjacent turns of the coil 610 abutting each other, with each turn interlocking with adjacent turns of the coil 610 disposed above and below it when one or more of the protrusions 622 engage with a corresponding groove 618. The interlocking of the grooves 618 and the protrusions 622 prevents relative motion between the respective mechanisms, thereby preventing the coil 610 of the docking device 600 from physically unwinding. This arrangement therefore also serves to increase the radial force and ultimate retention force between the docking device 600 and a replacement valve expanded within the docking device 600.

[0080] FIG. 19 shows a perspective view of an exemplary coiled anchor or docking device. The docking device 1100 of FIG. 19 may be of the same or similar construction as the docking device 100 of FIG. 10 described above and may include any of the features and characteristics described with respect to the docking device 100. The docking device 1100 may also have a central region 1110, a lower region 1120, an upper region 1130, and an expansion region 1140. The lower region 1120 and the upper region 1130 may form a larger coil diameter than the central region 1110, and the expansion region 1140 may vertically space the upper region 1130 from the central region 1110, similar to the above. The docking device 1100 is also positioned or wound such that advancement of the docking device 1100 into the left ventricle may be performed counterclockwise as viewed through the annulus in the outflow direction (e.g., from the atrium to the ventricle). Other embodiments may instead facilitate clockwise advancement and deployment of the docking device.

[0081] In the embodiment of FIG. 19, the central coil / turn 1110 of the docking device 1100 also serves as a functional coil turn, providing the primary docking site for the prosthetic valve or THV expanded therein. The central turn 1110 is generally positioned in the left ventricle, while a smaller distal portion, if any, extends through the native annulus into the left atrium, as described in more detail below. In an example where the THV has an expanded outer diameter of 29 mm, the central turn 1110 can have an inner diameter in the range of 20 mm to 30 mm, and in an exemplary embodiment, can be about 23 mm (e.g., ±2 mm) to provide a retention force between the parts of about 16 N, sufficient to stably hold the expanded THV within the docking device 1100 and prevent the THV from dislodging from the docking device 1100 even during severe mitral valve pressures.

[0082] Meanwhile, the lower region 1120 of the docking device 1100 functions as the leading coil turn (e.g., ventricular encircling turn). The lower region 1120 comprises the distal tip of the docking device 1100 and flares radially outward from the central turn 1100 to capture the native valve leaflets as well as some or all of the chordae tendineae and / or other mitral valve anatomy when the docking device 1100 is advanced into the left atrium. Native mitral valves exhibiting mitral regurgitation typically measure an A2P2 distance of approximately 35 mm and a commissure-to-commissure distance of 45 mm. Thus, when a 29 mm THV is used, the small size of the THV, and consequently the size of the central turn 1110, is smaller than the long axis of the mitral valve anatomy. In this manner, the lower region 1120 is initially formed to have an enlarged size or profile compared to the central turn 1110 to more easily guide the docking device 1100 around both native 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 native valve (e.g., 45 mm) such that the distal tip extends that distance away from the exit of the delivery catheter during delivery of the docking device 1100.

[0083] The upper region 1130 of the docking device 1100 functions as a stabilizing coil turn (e.g., atrial coil / turn) that provides a self-retaining mechanism for the docking device 1100 during the transition phase before delivery of the THV after the docking device 1100 is deployed at the native valve. The left atrium generally flares outward from the mitral annulus, forming a funnel-like shape that flares from the annulus. The diameter of the upper region 1130 is selected so that the upper region 1130 conforms to approximately the desired height of the left atrium and to prevent the upper region 1130 from sliding further down toward the native mitral annulus after the desired position is achieved. In one example, the upper region 1130 is formed to have a diameter of 40-60 mm, such as a diameter of about 53 mm.

[0084] In addition, the shape and location of the upper region 1130 is selected such that after the THV is expanded within the docking device 1100, the upper region 1130 exerts minimal or no pressure on the portion of the atrial wall adjacent to the aortic wall. FIG. 20 is a schematic top view of a portion of the heart showing the left atrium 1800 and the mitral valve 1810 located in its central region. In addition, the approximate location of the aorta 1840 is also shown diagrammatically. Meanwhile, the docking device 1100 has been delivered to the native mitral valve 1810 at the commissure A3P3, 1820. It is noteworthy here that the upper region 1130 of the docking device 1100 is located away from the wall 1830 of the left atrium 1800. Additionally, as the THV expands within the docking device, the central region 1110 of the docking device 1100 tends to expand and unfold slightly, which can pull the upper region 1130 further away from the atrial wall 1830 (e.g., counterclockwise and downward, as shown in FIG. 20). Further details of the positioning of the docking device 1100 relative to the mitral valve 1810 are discussed in more detail below with further reference to FIG.

[0085] The extension region 1140 provides vertical extension and spacing between the central region 1110 and the upper region 1130 of the docking device 1100. In some embodiments, the extension region 1140 of the docking device 1100 (and the extension 140 of the docking device 100) may be referred to as an elevation turn. The location where the docking device 1100 intersects with the mitral valve plane is important to maintain the integrity of the native valve anatomy, particularly the leaflets and commissures, to serve as a proper docking site for the final implantation of the THV. With a docking device lacking such an extension or elevation region 1140, more of the docking device would seat on or against the mitral plane, pinching the native leaflets, and relative movement or rubbing of the docking device against the native leaflets could potentially damage the native leaflets from the atrial side. Having the extension region 1140 allows the portion of the docking device 1100 positioned in the left atrium to elevate and move away from the mitral plane.

[0086] Additionally, the expansion region 1140 of the docking device 1100 may also have a smaller diameter cross-section. In the illustrated embodiment, the wire core of the other regions of the docking device 1100 may have a diameter of, for example, 0.825 mm, while the core of the expansion region 1140 may have a diameter of 0.6 mm. In another embodiment, the wire core of the other regions of the docking device may have a cross-sectional diameter of 0.85 mm, while the expansion region has a cross-sectional diameter of 0.6 mm. When the other regions of the docking device coil have a cross-sectional diameter of 0.825 mm or more, or a cross-sectional diameter of 0.85 mm or more, the expansion region 1140 may have a cross-sectional diameter of 0.4 to 0.8 mm. The thicknesses may be selected based on the ratio of each other. The expansion region may have a cross-sectional diameter of 50% to 75% of the cross-sectional diameter of the remainder of the wire. The expansion region 1140 with a smaller cross-section may allow a sharper angle of ascent of the expansion region 1140 from the mitral plane. The radius of curvature and wire cross-section of the expansion region 1140 may further be selected, for example, to provide sufficient connection points between the central region 1110 and the top region 1130 of the docking device 1100 and / or to allow the expansion region 1140 to be more easily deployed and retrieved with less force during delivery since a thinner wire core is generally easier to straighten and bend. Additionally, in embodiments where a shape memory wire core such as NiTi is used for the wire core, the thickness of both the expansion region 1140 and the remainder of the docking device 1100 should be selected so as not to exceed any strain limits based on the material properties of the selected material or materials.

[0087] As mentioned above, the wire core of the docking device 1100 may be made of NiTi, other shape memory materials, or other biocompatible metals or other materials, but the wire core may be covered with one or more additional materials. These cover or layer materials may be attached in a variety of ways, including, for example, gluing, melting, molding, etc. around the core, or the cover / layer may be sewn, tied, or bonded to the wire core. With brief reference to FIG. 22, a cross section of a distal portion of the docking device 1100 includes a wire core 1160 and a cover layer 1170. The wire core 1160 may provide, for example, strength to the docking device 1100. Meanwhile, the base material of the cover layer 1170 covering the wire core 1160 may be, for example, ePTFE or other polymers. Because the cover layer 1170 is more compressible than the wire core 1160, the wire frame and / or struts of the THV can be partially wedged or otherwise secured within the cover layer 1170 to increase stability when the THV is expanded within the docking device 1100. The highly compressible material also allows pinching or compression of the native valve leaflets and other anatomical structures between the docking device 1100 and the THV to be less traumatic, resulting in less abrasion and / or damage to the native anatomical structures. In the case of ePTFE, the material is also not water or blood permeable, but allows ethylene oxide gas to pass or permeate therethrough, thereby providing a layer through which the underlying wire core 1160 can be more easily sterilized. On the other hand, while not blood permeable, the ePTFE cover layer 1170 may be constructed with a pore size of, for example, 30 microns, to facilitate easy anchoring of blood cells into and onto the outer surface of the cover layer 1170, for example, to facilitate tissue ingrowth after implantation. Additionally, ePTFE is also a very low friction material, and the docking device 1100 having an ePTFE cover layer 1170 provides stability and promotes ingrowth.

[0088] While a low friction ePTFE cover layer 1170 can aid in the interaction between the ends of the docking device 1100 and the anatomy of the native heart, additional friction may be more desirable in the central region 1110 that provides the functional coils of the docking device 1100 for docking the THV. Thus, as seen in FIG. 19, an additional cover 1180 (which may be the same or similar to cover 420 and / or friction element 520, as appropriate) may be added to the central region 1110 of the docking device 1100, on top of the ePTFE layer 1170. FIG. 19A shows a cross-sectional view of the layers. When the THV is expanded within the docking device 1100, the cover 1180 (depicted as a braided layer) or other high friction layer provides additional friction between adjacent coils and against the native leaflets and / or the THV. The friction formed 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 to more firmly secure the THV and docking device 1100. The braided layer or high friction cover / layer 1180 does not extend into either the lower region 1120 or the extended region 1140 since the functional coil turns or central region 1110 of the docking device 1100, i.e., the area of ​​the docking device that interacts with the THV, are generally the only areas where a high friction cover / layer is desired, as seen in FIG. 19. As a result, these areas of the docking device 1100 remain low friction along with the upper region 1130 to facilitate less traumatic interaction with the native valve and other cardiac anatomical structures. Additional frictional elements and thus improved retention between the docking device and the replacement valve may also be added to the device via any combination of high friction cover / layer 1180 and high friction elements or other features described herein and illustrated in Figures 15-18.

[0089] 20 is a top view showing a possible placement of the docking device 1100 in a native mitral valve 1810 prior to expansion of the THV therein. In this embodiment, the docking device 1100 is advanced counterclockwise through the commissures A3P3, 1820 of the mitral valve 1810 into the left ventricle. When a desired amount of the docking device 1100 (e.g., the lower region 1120 and most of the central region 1110) has been advanced into the left ventricle, the remaining turns of the docking device 1100, e.g., the central region 1110 (if any), the expansion region 1140 (or a portion thereof), and any remaining portions of the upper region 1130, are released from the delivery catheter, e.g., by clockwise or counterclockwise rotation of the delivery catheter. This allows the central region 1110 and the lower region 1120 of the docking device 1100 to be unsheathed or otherwise released while the position of these regions remains stationary or substantially in place relative to the surrounding anatomy. In Figure 20, the portion of the device 1100 below the native valve is depicted in dotted lines.

[0090] Correct positioning of the docking device 1100 can be very important. In one embodiment, the docking device 1100 should be positioned relative to the native valve 1810 such that the desired portion of the docking device 1100 extends through the native valve 1810 at or near the commissure A3P3 and contacts the atrial side of the native valve leaflets. For example, as seen in FIG. 19, the proximal portion of the central region 1110 of the docking device 1100 extends between the proximal tip of the cover layer or braided layer 1180 and the expansion region 1140, where the ePTFE or low friction layer 1170 remains exposed. Preferably, this ePTFE or low friction region is the portion of the docking device 1100 that crosses the mitral plane and contacts the atrial side of the native valve leaflets. On the other hand, the portion of the docking device 1100 that passes through the mitral valve may, for example, be a portion of the exposed central region 1110 immediately adjacent the end of the covering or braided layer 1180, or may also include some of the proximal tip of the covering or braided layer 1180.

[0091] Advancement of the lower coil or ventricular coil of the docking device 1100 into the left ventricle must be precise. To facilitate this, one or more marker bands or other visualization features can be included in any of the docking devices described herein. FIG. 21 is a top view showing an alternative embodiment of the docking device 1100 in which two marker bands 1182, 1184 have been added to the docking device 1100. The marker bands 1182, 1184 are positioned adjacent to one another. While the marker bands and / or visualization features can be positioned in various locations, in FIG. 20, the first marker band 1182 is positioned at the proximal tip of the high friction layer 1180 and the second marker band 1184 is positioned a short distance away from the proximal tip of the high friction layer 1180. One marker band 1182 can be made thicker than the other marker band 1184 for easy differentiation. The marker bands 1182, 1184 or other visualization mechanism provide landmarks to easily identify the location of the proximal tip of the high friction layer 1180 relative to both the delivery catheter and the native mitral valve anatomy. Thus, the physician may use the marker bands 1182, 1184 or other visualization mechanism to determine when to stop advancing the docking device 1100 into the left ventricle (e.g., when the marker bands are in a desired orientation near the commissure A3P3) and when to begin releasing or unsheathing the remaining proximal portion of the docking device 1100 into the left atrium. In one embodiment, the marker bands 1182, 1184 are visualized under fluoroscopy or other 2D imaging modality, although the invention should not be so limited. In some embodiments, one or both marker bands are instead positioned on the low friction layer 1170 near the end of the braided layer 1180 or on other portions of the docking device 1100 based on the user's preference. In other embodiments, fewer or more marker bands may be used. The braided layer 1180 may extend across the portion of the docking device coil that engages the replacement heart valve.

[0092] Any of the docking devices herein may be further improved, for example, to facilitate or assist in advancing the docking device into the proper position relative to the native valve. For example, improvements may be made to help prevent the native valve and other native cardiac tissue from being damaged by the docking device during implantation and positioning of the docking device. For mitral valve applications, when the tip or distal tip of the coiled docking device is introduced into the left ventricle and rotated as previously described, the distal tip is sized, shaped, and / or otherwise configured to more easily guide around the chordae tendineae. In contrast, the distal tip should also be made in an atraumatic manner so that advancement of the distal tip around and / or through the mitral or other valvular anatomy does not damage the anatomy.

[0093] Meanwhile, in some embodiments, the proximal tip of the docking device is attached to a pusher in the delivery catheter that pushes the docking device out of the distal opening of the catheter. Herein, the terms pusher, pusher device, and push rod are used interchangeably and can be substituted for one another. While attached to the docking device, the pusher can help push, pull, or retrieve the docking device relative to the delivery catheter to allow repositioning of the docking device at any stage throughout the delivery process. The methods described herein can include various steps associated with retrieval and repositioning of the docking device, such as withdrawal or retraction of push rods / sutures / tethers or other mechanisms to pull the docking device back into the delivery catheter, followed by repositioning and reimplantation of the docking device in a different position / orientation or location. In the case of docking devices having a cover layer, such as a fabric layer, that covers the coil skeleton of the docking device, adjustment of the docking device by the pusher may lead to frictional forces exerted, for example, by the anatomy of the heart and / or by the pusher / push rod / pusher device itself, against the cover layer, particularly at the proximal and distal tips of the docking device. Thus, the structure at the ends of the coil of the docking device and the connection techniques (e.g., adhesive or suturing techniques) for connecting the fabric layer to the coil may be important both to handle and address such frictional forces and to prevent tearing of the fabric layer from the coil or the ends of the coil.

[0094] In view of the above considerations, the docking device 1100 may include atraumatic distal and proximal tips. FIG. 22 shows a cross-sectional view of the proximal tip of the docking device 1100, illustrating the respective geometries of the wire core 1160, which may be made of, for example, NiTi, and the low-friction cover layer 1170, which may be made of, for example, ePTFE or other polymers. The low-friction cover layer 1170 may extend slightly further beyond the end of the wire core 1160 and taper to a rounded tip. The rounded extension region provides space for the low-friction cover layer 1170 to secure to and around the wire core 1160 while also forming an atraumatic tip. The distal tips of the docking device apparatuses herein (e.g., the docking device 1100) may be constructed or arranged to have a similar structure.

[0095] 19 and 22, the docking device 1100 may optionally further include fastening holes 1164 near each of the proximal and distal tips. Using the fastening holes 1164, the cover layer 1170 may be further secured to the wire core 1160, for example, via sutures or other fasteners. This and / or similar fastening means may 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, the cover layer 1170 may be glued, melted, molded, etc., without suturing around the core.

[0096] In some embodiments, the distal tip of the docking device 1100 may be tapered slightly radially inward, e.g., tangent to the circular shape formed by the coils of the central region 1110. Similarly, the stabilizing coils / turns or top region 1130 of the docking device 1100 may also be tapered slightly radially inward, e.g., tangent (or have a portion that is tangential) to the circular shape formed by the coils of the central region 1110. Alternatively, it may be pointed upward, e.g., toward the roof of the atrium and away from the other coils of the docking device 1100. The top region 1130 of the docking device 1100 may be configured this way as a precaution, e.g., if the docking device 1100 is not placed in the desired position described above and slides toward the left ventricle, potentially causing the top region 1130 to come into contact with the mitral surface, or if the docking device 1100 is implanted in a heart with abnormal anatomy.

[0097] With regard to facilitating attachment of the docking device 1100 to a pusher / push rod or other advancement or retrieval mechanism in the delivery catheter, the proximal tip of the docking device 1100 may further include a second hole or bore 1162. As shown in FIG. 22A, the hole or bore 1162 may be sized such that a retention device, such as a long release suture 1163, may be looped therethrough to connect or attach the docking device 1100 to the distal tip of a pusher or other mechanism of the delivery catheter. The hole 1162 may be rounded and smooth to prevent unintended release suture function. The release suture may provide a more secure attachment of the docking device 1100 to the delivery catheter and may also allow for pull-retrieval of the docking device 1100 when retraction, partial retrieval, or full retrieval of the docking device 1100 is desired. FIG. 22C is a detailed view showing the release suture 163 looped through the bore 1162 of the docking device 1100, with the outside of the delivery catheter 1010 cut away. The pusher device 1165 is configured as a pusher tube having a lumen extending therethrough, e.g., end-to-end. The suture in this embodiment extends through a longitudinal hole through the pusher device / tube 1165 retained within the delivery catheter 1010. Alternatively, once the desired positioning of the docking device 1100 is achieved, the physician or other user can simply cut the proximal portion of the release suture and pull the release suture proximally to pass the cut end of the suture through the hole 1162, thereby releasing the docking device 1100 from the delivery catheter. In one embodiment, the suture may extend in a loop such that the suture extends from the bore 1162 through the pusher device / tube 1165 to a handle or hub external to the patient (the loop can be closed or open with two ends secured to the handle or hub). When cut, a portion of the suture may remain attached to the handle or hub (or be otherwise held by the healthcare provider), allowing the suture to be pulled proximally until the cut end exits the bore 1162, releasing the delivery device.FIG. 22B shows another embodiment in which a suture 1163 is looped through a bore 1162 to the proximal tip of the coil.

[0098] Various further improvements can be made to the distal or proximal tip, or both tips, of any of the docking devices described herein that can make the docking device more robust. FIG. 23 illustrates the distal tip of a coil skeleton or core of a docking device according to another embodiment of the present invention. The distal tip of the coil / core 710 can be made of or include Nitinol, other shape memory metals or materials, and / or non-shape memory materials. The distal tip of the coil / core 710 has a substantially flat or rectangular cross-section with a distal ring-shaped tip 712. While the rectangular cross-section shown may be so shaped only at the distal tip of the coil 710 or may extend the length of the coil 710, in other embodiments the entire coil 710, including the distal tip region, may have a more circular cross-section or a cross-section of other shapes. The ring-shaped tip 712 has an enlarged 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 sutures. A free end 716 of the ringed tip 712 may be arranged as an arc or other curved arch, while a proximal tip 718 opposite the tip 712 may be formed as a rounded or tapered transition between the tip 712 and an adjacent region. Near the distal tip 712, the coil 710 may further include one or more cover fastening holes 720 to further aid in securing a cover layer disposed over and attached to the coil 710.

[0099] The cover layer covering the coil skeleton / core 710 of the docking device can be, for example, one or more of the covers or layers described above (e.g., low friction and / or high friction covers). The cover layer can be, for example, made of or include an ePTFE core tube wrapped with a PET woven fabric, or can be made of or include any other fabric 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 or slightly beyond the end 718 of the distal tip 712. The cover layer can then be connected to the ring-shaped distal tip 712, for example, via a suture passing through the through hole 714 and passing over and covering the arched free end region 716. The suture serves to secure the cover layer to the coil skeleton / core 710 and also serves to soften the edge of the ring-shaped distal tip 712. Additional sutures may be provided by passing them through one or more cover fixation holes 720 near the distal tip 712. The cover layer is secured to the coil scaffold / core 710.

[0100] FIG. 24 illustrates a distal tip of a coil skeleton or core of a docking device that can be used with any of the docking devices described herein. The distal tip of the coil / core 810 can also be made of or include Nitinol, other shape memory metals or materials, and / or other non-shape memory materials. The distal tip of the coil / core 810 has a distal ball-shaped tip 812. The ball-shaped tip 812 can be preformed with the rest of the coil skeleton / core 810 or can be a separate ball-shaped or short club-shaped appendage with a rounded end that is welded or otherwise attached to the distal tip of the coil / core 810. Meanwhile, a small gap 814 is formed or left between the ball-shaped tip 812 and the rest of the coil / core 810. The gap 814 can be about 0.6 mm or other size sufficient to facilitate the passage and / or crossing of one or more sutures to secure or otherwise connect a cover layer to the distal tip of the coil / core 810.

[0101] The one or more cover layers or covers covering the coil skeleton / core 810 of the docking device can be similar to the cover layers or covers previously described. The cover layers / covers can be made of or include, for example, an ePTFE core tube wrapped with a PET woven fabric, or can be made of or include any other fabric or other biocompatible material. In one attachment method, such a cover layer / cover covers the body of the coil skeleton 810 over the gap 814 and up to the ball-shaped tip 812, while leaving the free end of the ball-shaped tip 812 exposed. The cover layer / cover is then connected to the distal tip of the coil 810, for example, via a suture passing through the gap 814. In a second attachment method, the entire ball-shaped tip 812 is wrapped and completely covered with the cover layer, and then a suture passes through and / or crosses the gap 814 to secure the entire cover layer to the ball-shaped tip 812.

[0102] The distal tips 712, 812 illustrated in and described with respect to FIGS. 23 and 24 have a compact nose that allows for easier and more convenient navigation of the respective docking device within the left ventricle, providing the respective docking device with a rounded distal tip. Furthermore, because each of the tips 712, 812 is curved or rounded, the tips 712, 812 form ends with soft edges. The shape and structure of the distal tips of the respective coil skeletons 710, 810, the type, texture, and structure of the cover layer, as well as the suturing technique for attaching the cover layer to the coil skeletons 710, 810 also allow for a tight connection between the distal tips 712, 812 and the respective cover layer without the use of glue or other adhesives. Furthermore, the tip structure and arrangement prevent exposure of sharp edges as a result of frictional forces applied to the cover layer of the docking device during or after delivery, and also prevent the surfaces of the coil skeletons 710, 810 from cutting and / or protruding from the cover layer.

[0103] As mentioned above, in some embodiments, the docking device may be attachable to a pusher that may make it easier to push and pull the docking device for delivery and realignment purposes. Figure 25 shows the proximal tip of the coil skeleton / core 910 of the docking device 900 (which may be the same or similar to other docking devices described herein), and Figure 26 shows the proximal tip of the docking device 900 with a cover layer 920 over the coil skeleton / core 910 and sutures 930 attaching the cover layer 920 to the coil skeleton / core 910.

[0104] Referring initially to FIG. 25, the coil skeleton / core 910 of the docking device 900 has a proximal tip region having a substantially flat or rectangular cross-section, similar to the cross-section of the distal tip of the coil / core 710 described above. The rectangular cross-section shown may be so shaped only in the proximal tip region of the coil / core 910, or may extend the length of the coil / core 910, and in other embodiments, the entire coil / core 910, including the proximal tip region, may have a more rounded or other shaped cross-section. An oval or elongated slit hole 912 extends through the proximal tip region of the coil / core 910, where two sides 914, 916 of the coil / core 910 extend along one side of the slit hole 912 and connect the proximal free end 918 of the coil / core 910 to the remainder of the coil / core 910. The slit hole 912 is wide enough to allow a needle and / or one or more sutures 930 to pass through or cross.

[0105] As shown in FIG. 26, the cover / cover layer 920 can be, for example, a cover, fabric layer, or other layer configured the same or similarly as described above with respect to the previous embodiments of the docking device. The cover / cover layer 920 is wrapped around the coil skeleton / core 910 and anchored or otherwise secured to the coil / core 910 by a suture 930 that runs along and passes through the slit hole 912. The suture 930 can cross the slit hole 912 in an "8" shape, as shown in FIG. 26, where the suture 930 is passed through the slit hole 912 at least two times and wrapped at least once around the opposing sides 914, 916 of the coil / core 910 adjacent the slit hole 912. In the illustrated embodiment, the suture 930 is passed through the slit hole 912 at least four times and wrapped at least twice around the sides 914, 916 on either side of the slit hole 912. The suture 930 is positioned proximal to or moved proximally towards the slit hole 912 near the free end 918 of the coil skeleton / core 910, so that the distal tip of the slit hole 912 remains exposed and accessible to the user, for example, remaining open large enough for a pull wire 940 (e.g., a release suture) of a pusher of a delivery catheter to pass through or cross, thereby establishing a secure connection between the docking device 900 and the pusher. The pull wire 940 may be a suture.

[0106] When the docking device 900 is connected to the pusher via the pull wire 940, the distal tip of the pusher (not shown) abuts the proximal free end of the docking device 900 or the pull wire 940 abuts the distal tip of the slit hole 912 to advance the docking device 900 out of the delivery catheter. On the other hand, if it is desired to pull back or retract the docking device 900, for example to realign the position of the docking device 900 at the implantation site, the pull wire 940 may be pulled proximally to retract the docking device 900 proximally as well. Similar steps may be used with other docking devices herein. When the pull wire 940 is pulled back, it abuts the suture 930 extending through the slit hole 912, which forms a cross suture area that helps provide a cushioned landing area against which the pull wire 940 may abut, via an "8" suture. Thus, the sutures 930 serve to securely attach the cover layer 920 to the coil skeleton / core 910 while masking or covering the sharp edges of the slit layer 912 to protect the pull wires 940 from being damaged or ruptured by docking, and conversely, protect the docking device 900 from being damaged by the pull wires 940 during retrieval or other pulling of the docking device 900.

[0107] 23 and 24, the shape and configuration of the proximal tip of the coil skeleton / core 910, the type, texture, and configuration of the cover / cover layer 920, and the connection technique (e.g., suturing technique) for attaching the cover / cover layer 920 to the coil skeleton / core 910 each contribute to a tight connection between the proximal tip of the coil 910 and the cover / cover layer 920, which can be accomplished without the use of glue or other adhesives (e.g., suturing technique does not require these). Additionally, the tip structure and configuration prevents exposure of sharp edges and prevents surfaces of the coil skeleton / core 910 from cutting and / or protruding from the cover / cover layer 920 as a result of frictional forces applied to the cover / cover layer 920 of the docking device 900 during or after delivery.

[0108] In various other embodiments, any or all of the different features from the different embodiments described above may be combined or refined based on the needs of each individual patient. For example, different features related to a variety of different concerns (e.g., flexibility, increased friction, protection) may be incorporated into the docking device as needed for each individual application based on the specific characteristics or requirements of a particular patient.

[0109] The docking device embodiments herein have been generally discussed above with respect to being useful for anchoring replacement valves in the mitral position. However, as noted above, the docking device, as described, or slightly modified versions thereof, can be similarly applied to valve replacement in other valve sites, e.g., the tricuspid, pulmonary, or aortic positions. Patients diagnosed with insufficiency in either position may exhibit an enlarged annulus that prevents the native leaflets from properly coapting, and the annulus may be too large, too soft, or too diseased to securely hold the enlarged valve. Thus, the use of a rigid or semi-rigid docking device may also be beneficial to anchor replacement valves in those valve sites, e.g., to prevent dislodging of the replacement valve during normal cardiac function.

[0110] The docking devices herein may be further covered with one or more covers or cover layers, similar to those described above. Additionally, the cover layers for any of these applications may also be made from or include materials that promote more rapid tissue ingrowth. The cover layers may further be configured to have a larger surface area, for example, with a velour film, a porous surface, a braided surface, etc., to further enhance tissue ingrowth.

[0111] When applied to valves other than the mitral valve, docking devices similar to those discussed above may also provide a safer landing zone at these sites. The docking devices and associated replacement valves may be applied similarly to those described with respect to implantation in the mitral valve. A possible access point for tricuspid valve replacement may be, for example, transseptal access, and a possible access point for aortic replacement may be, for example, transfemoral access, but the access to the respective valve sites is not limited thereto. The use of coil-shaped docking devices as previously described at other valve sites may also serve to circumferentially pinch or clamp the native leaflets after deployment of the replacement valve at the native annulus, for example, by the presence of leaflets and other tissues, which are pinched between the coils of the docking device and held in place by the spring force of the docking device, further preventing slippage or other movement of the docking device and the pinched tissue relative to the docking device, and preventing undesired growth or expansion of the native annulus.

[0112] For the purpose of this description, certain aspects, advantages, and novel features of the disclosed embodiments are described herein. The disclosed methods, devices, and systems should not be construed as limiting in any way. Instead, the disclosure is directed to all novel and non-obvious features and aspects of the various disclosed embodiments, both alone and in various combinations and subcombinations with each other. The methods, devices, and systems are not limited to any particular aspect or feature or combination thereof, which may be combined, and the disclosed embodiments do not require that one or more particular advantages exist or problems be solved.

[0113] Although some operations of the disclosed embodiments are described in a particular sequential order for convenience of presentation, it should be understood that this method of description includes rearrangements unless a particular order is required by specific language below. For example, operations or steps described sequentially may in some cases be rearranged or performed simultaneously. Moreover, for simplicity, the accompanying drawings may not show the various ways in which the disclosed methods may be used in conjunction with other methods. Furthermore, the description may use terms such as "provide" or "achieve" to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by those of ordinary skill in the art.

[0114] In view of the many possible embodiments to which the principles of the present disclosure may be applied, it should be recognized that the illustrated embodiment is merely a preferred example and should not be construed as limiting the scope of the present disclosure, which is rather defined by the appended claims. [Explanation of symbols]

[0115] 1, 100, 200, 300, 400, 500, 600, 1100 Docking Device 10, 110, 1100 central area 20, 120, 1120 bottom area 21 Tip 30, 130, 1130 upper area 31 Proximal tip 32 Long axis diameter 33 Minor axis diameter 40 Artificial Valves 41 Frame 42 Valve leaflet 50 Mitral Valve 52 Left atrium 54 Left ventricle 56 Aortic Valve 58 Aorta 62 Chordae tendineae 140 Extension 150 Through hole 210 Laser cut tube 211, 216 cut 212 Interconnecting Links 213 teeth 214 Groove 215 End area 217, 218 Wire lock mechanism, opening 219 Wire 222 Distal tip 310 Main coil 320 Anchor 410 Coil / Core 420 Cover 510, 610 coil 520 Friction element 530 High Friction Cover 618 Groove or notch 622 Protrusion 710 Coil skeleton / core 712 Ringed tip, distal tip 714 Through hole 716 Free end area 718 End 810 Coil skeleton / core 812 Ball Tip, Distal Tip 814 Gap 910 Coil skeleton / core 912 Slit hole 914, 916 Side 918 Free end 920 Cover Layer 930 Sutures 940 Pull Wire 1000 Guide Sheath 1010 Delivery catheter 1110 center coil / turn 1140 Expansion Area 1160 Wire Core 1162 Hole or bore 1163 Detachment suture 1164 Fixed hole 1165 Pusher Device / Tube 1170 Cover layer, low friction layer 1180 High friction cover / layer, braided layer 1182, 1184 Marker Bands 1800 left atrium 1810 Mitral valve 1820(A3P3, A1P1) commissure 1830 Wall 1840 Aorta

Claims

[Claim 1] A docking device as described herein and in the drawings.

Images