Heart valve docking system

Abstract

The docking device can be configured to be positioned at the native valve of the human heart to provide structural support for docking an artificial valve. The docking device typically has a coiled structure that defines an interior space in which the artificial valve can be held. After the docking device has been delivered to more securely hold the artificial valve, some docking devices can be adjusted from a first wider structure that helps to more easily advance the docking device around the valve anatomy to a second narrower structure. After adjusting to the narrower structure, the docking device can also be better maintained in the appropriate position at the native valve. Some docking devices include a stabilizing section or a dual coil structure, in which the main coil area is configured to securely hold the artificial valve, and the stabilizing coil area is configured to more stably hold the docking device at the native valve.

Description

[0001] This application is a divisional application of Chinese patent application 201780061726.8 (PCT / US2017 / 048620) filed on August 25, 2017, entitled “Heart Valve Docking System”.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims priority to U.S. Provisional Patent Application Serial No. 62 / 380,117, filed on August 26, 2016. This application also claims priority to U.S. Provisional Patent Application Serial No. 62 / 395,940, filed on September 16, 2016. Each of the above applications, as well as U.S. Patent Application No. 14 / 372,953, filed on July 17, 2014, and entitled “Mitral Valve Docking Devices, Systems, and Methods,” and U.S. Patent Application No. 15 / 682,287, filed on August 21, 2017, are incorporated herein by reference in their entirety. Technical Field

[0004] The present invention generally relates to medical devices and procedures related to prosthetic heart valves. More specifically, the present invention relates to the replacement of heart valves that may be dysfunctional or have malformations. Embodiments of the present invention relate to anchoring or docking devices that are capable of retaining and maintaining the position of a prosthetic heart valve therein to replace the function of a native heart valve, such as for mitral or tricuspid valve replacement procedures. Embodiments of the present invention also relate to implantation procedures associated with such anchoring or docking devices or with assemblies including such anchoring or docking devices and a prosthetic heart valve. Background Art

[0005] Description of related prior art

[0006] See first Figure 1 and Figure 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 oxygenated blood from the left atrium 52 to flow into the left ventricle 54. Subsequently, the left ventricle 54 contracts, and the oxygenated blood held in the left ventricle is delivered to the rest of the body through the aortic valve 56 and the aorta 58. At the same time, during this ventricular contraction, the mitral valve should close to prevent any blood held in the left ventricle from flowing back into the left atrium.

[0007] When the left ventricle contracts, the blood pressure in the left ventricle increases substantially, which serves to force the mitral valve to close. Due to the large pressure differential between the left ventricle and the left atrium during this period, a large amount of pressure is placed on the mitral valve, causing the mitral valve to prolapse or the leaflets of the mitral valve to evert into the left atrium. To prevent this, a network formed by chordae tendineae 62 connects the leaflets of the mitral valve to the papillary muscles located on the wall of the left ventricle, wherein both the chordae tendineae and the papillary muscles are tensioned during ventricular contraction to hold the leaflets of the mitral valve in a closed position and prevent them from everting inside out and extending back toward the left atrium, thereby preventing the backflow of oxygenated blood into the left atrium. Figure 1 Heart cross section and Figure 2 The network formed by the chordae tendineae 62 is schematically illustrated in the mitral valve of FIG. Figure 2 Also shown is the general shape of the mitral valve and its leaflets as viewed from the left atrium.Commissures 64 are located at the ends of the mitral valve 50 where the anterior leaflet 66 and the posterior leaflet 68 come together.

[0008] Various complications of the mitral valve and other valves can lead to potentially fatal heart failure. One form of valvular heart disease is mitral valve leakage or mitral regurgitation, which is characterized by abnormal leakage of blood from the left ventricle through the mitral valve back into the left atrium. This can be caused, for example, by enlargement of the heart, weakening of the chordae tendineae and / or papillary muscles, or by damage to the native leaflets. In these cases, it may be necessary to repair the native valve or replace the function of the native valve with an artificial heart valve.

[0009] With respect to mitral valve replacement, historically, there has been less research and development into commercially available methods for replacing the mitral valve through transcatheter approaches and / or other minimally invasive or less invasive procedures. Mitral and tricuspid valve replacement can be more difficult in many respects than aortic valve replacement, for example, due to the non-circular physical shape of the mitral valve, its subannular anatomy, and the valve being more difficult to access due to its deeper location in the heart.

[0010] Mitral and tricuspid valve replacement using a prosthetic aortic valve or a similar circular or cylindrical prosthetic valve may also be beneficial. However, one problem with replacing the mitral valve in this manner is the size and non-circular shape of the native mitral annulus, such as Figure 2 Visible. The aortic valve is more rounded in shape, and therefore, prosthetic transcatheter aortic valves also have a more rounded or cylindrical valve frame. Furthermore, in many cases of aortic valve replacement, the need for valve replacement stems from aortic stenosis, in which the aortic valve is narrowed due to calcification or other sclerosis of the native leaflets. Therefore, in these cases, the aortic annulus typically provides a native, round, compact, and stable anchoring site for the prosthetic valve.

[0011] On the other hand, both the mitral and tricuspid valves are larger than the aortic valve and more elongated in shape, making them more challenging and unconventional locations for implanting replacement valves with generally round or cylindrical valve frames. A circular prosthetic valve that is too small can lead to leakage around the implant (i.e., paravalvular leak) if a good seal is not established around the valve, while a circular prosthetic valve that is too large can protrude and damage the narrower portion of the native mitral annulus.

[0012] Another significant obstacle to effective mitral valve replacement stems from the large cyclic loads to which the replacement valve will be subjected and the need to establish a sufficiently strong and stable anchoring and retention of the prosthetic valve in the mitral annulus that can withstand such forces during ventricular contraction without moving, particularly due to cardiac motion and / or pressure exerted on the implant. In addition, such motion and rhythmic loads can easily fatigue the implant, leading to valve rupture or other damage to the valve. Moreover, if the valve prosthesis manages to remain in the mitral valve position, even a slight shift in the alignment of the valve may still result in blood flow through the valve or other parts of the heart (e.g., the left ventricular outflow tract) being occluded or otherwise adversely affected. Summary of the Invention

[0013] One approach to adapting existing circular or cylindrical transcatheter valve technology to non-circular valve replacements (e.g., mitral valve replacements) is to use an anchoring or docking station or other docking device that forms or otherwise provides a more circular docking site at the native valve site to hold the prosthetic valve. Thus, an existing expandable transcatheter valve developed for the aortic site, or a similar valve that has been slightly modified to more effectively replicate valve function other than aortic valve function, can be more securely implanted at the native valve site using such a docking station. Such a docking station can first be positioned at the native annulus, and thereafter, the valve implant can be advanced and positioned through the docking station in a collapsed configuration, and can then be expanded, for example, via balloon expansion, self-expansion (e.g., when the frame is made of a shape memory material such as NiTi), or mechanical expansion, such that the frame of the valve implant pushes radially against the docking station to hold the valve implant in place. Preferably, the docking station can be delivered using minimally invasive or less invasive techniques (e.g., the same or similar transcatheter methods used to deliver valve implants) such that the docking device and valve implant do not need to be delivered using completely separate and / or independent procedures.

[0014] Therefore, it is desirable to provide devices and methods for facilitating the docking or anchoring of such replacement valves. The embodiments herein provide a stable docking station or docking device for retaining a prosthetic valve. Other features are provided to improve or facilitate the delivery of the docking device, to maintain the desired position of the docking device after it has been advanced to the desired position at the implantation site and prior to delivering the prosthetic valve, and / or to improve the retention of the prosthetic valve by the docking device after the valve in the docking device has been expanded. Such docking devices and methods can be used in some cases in the mitral valve position, but can also be used in other valve replacement procedures, for example, for tricuspid, pulmonary or aortic valve replacement, to provide a more secure and robust anchoring and retention of the valve implant at the native annulus in those locations.

[0015] Disclosed are docking devices for docking an artificial valve or valve prosthesis to a native valve of the heart and systems comprising such docking devices. The docking device may include a flexible body having one or more lumens extending through the flexible body (e.g., a first lumen extending through the flexible body and a second lumen extending through the flexible body). The docking device(s) may also include one or more coils (e.g., a first coil and a second coil). The flexible body may have a tubular structure, and the one or more lumens (e.g., the first lumen and the second lumen) may each extend completely or at least partially through the flexible body. The flexible body or tubular structure may have at least one complete or partial center turn, have another shape, or have no specific preset shape (e.g., a simple straight tube). The one or more lumens may each have one or more cross-sectional dimensions (e.g., area, diameter, width, etc.). For example, the first lumen may have a first cross-sectional area, and the second lumen may have a second cross-sectional area.

[0016] The one or more coils can be more rigid than the flexible body, and each coil can be configured to fit within one of the one or more cavities. The one or more coils can each have a plurality of circular turns, each circular turn defining a diameter (e.g., a coil diameter or a diameter of an interior space partially or completely surrounded by one or more of the turns), which can be the same as or different from the diameter of the other coils. For example, when a first coil and a second coil are used, the first coil can be more rigid than the flexible body, can be configured to fit within the first cavity, and can have a plurality of circular turns defining a first diameter. Similarly, the second coil can also be more rigid than the flexible body, can be configured to fit within the second cavity, and can have a plurality of circular turns defining a second diameter, the second diameter being smaller than the first diameter.

[0017] The docking devices and coils described herein can have a variety of configurations, such as a straightened or elongated delivery configuration, an unconstrained or relaxed configuration, a deployed or implanted configuration, a transitional configuration, combinations of these configurations, etc., and the configurations can have different shapes, sizes, diameters, etc.

[0018] For example, the docking device can have at least a first configuration and a second configuration. In one example, when a first coil is inserted through a first lumen or positioned within the first lumen (e.g., completely or at least partially within the first lumen), the first configuration can be adopted or formed. In this first configuration, the flexible body or docking device can define or have a third diameter (e.g., the coil diameter or the diameter of the interior space partially or completely surrounded by the flexible body or docking device). When a second coil is inserted through a second lumen or positioned within the second lumen (e.g., completely or at least partially within the second lumen), the second configuration can be adopted or formed. In this second configuration, the flexible body or docking device can define or have a fourth diameter that is smaller than the first diameter and / or larger than the third diameter. In the first configuration, the third diameter can be greater than or equal to the first diameter (or, in some cases, smaller than the first diameter). In the second configuration, the fourth diameter can be smaller than the first diameter and greater than or equal to the second diameter (or, in some cases, smaller than the second diameter).

[0019] Any of the (one or more) docking devices, coils, and / or flexible bodies herein may also have an upper turn. The upper turn may be configured to extend in a proximal direction from the other turns (e.g., from a plurality of turns). The (one or more) upper turns may be configured as stabilizing turns / coils to help prevent displacement of the docking device (e.g., after implantation of the docking device but before implantation of the prosthetic valve). The (one or more) upper turns may define an upper turn diameter that is greater than a diameter in another region of the docking device, coil, and / or flexible body. The elliptical upper turn may have a major axis diameter (e.g., between 40-100 mm) and a minor axis diameter (e.g., between 20-80 mm), both of which are greater than the first diameter. For example, the first coil may include an upper turn extending in a proximal direction from the plurality of turns, wherein the upper turn of the first coil is configured as a stabilizing turn to help prevent displacement of the docking device, the upper turn of the first coil defining an upper turn diameter that is greater than the first diameter.

[0020] Any of the docking device(s), coil, and / or flexible body herein may further comprise one or more coverings. For example, a high-friction cover on a portion of the flexible body may be configured to inhibit sliding of the docking device relative to the native leaflet when the docking device is implanted. Optionally, the covering may have a large surface area to promote tissue ingrowth.

[0021] The systems herein (e.g., systems for replacing heart valves) may include a docking device. The docking device may be the same or similar to the docking devices described above or elsewhere in this disclosure. For example, the docking device of the system may have a tubular body, a first coil and a second coil, and an interior space defined by the docking device in its second configuration (e.g., a relaxed or implanted / deployed configuration) as described above. (One or more) of the systems may also include a replacement valve (e.g., an artificial valve). The replacement valve may have an expandable frame and a plurality of leaflets. The replacement valve may be configured to be inserted into the interior space of the docking device and expanded to an expanded configuration. In its expanded configuration, the replacement valve may be configured to apply an outward pressure to the docking device that is sufficient to maintain a stable position of the replacement valve within the interior space of the docking device and / or relative to the native valve anatomy (e.g., native annulus, native leaflets, etc.). When deployed / implanted, some of the native anatomical structures (e.g., native leaflets, chordae tendineae, etc.) may be captured or squeezed between the docking device and the replacement valve.

[0022] The docking device used herein to dock an artificial valve or valve prosthesis at a native heart valve may include one or more coils / coil portions connected to each other. For example, the docking device may have a first coil having a proximal end, a distal end, and a plurality of turns extending between the proximal end and the distal end. The docking device may also have a second coil having a proximal end, a distal end, and at least one turn (e.g., a half turn, a full turn, a plurality of turns, between half and 5 full turns). At least one turn or a plurality of turns may extend between the proximal end and the distal end of the second coil. The second coil may be located at or near the distal end, the proximal end, or another portion of the second coil.

[0023] A portion of the first coil may be in contact with a portion of the second coil (e.g., they may meet at a bifurcation / split / joint). The first coil and the second coil may be formed integrally with one another, or may be formed as separate coils connected to one another. In one embodiment, the second coil may be connected to the first coil near the proximal end of the first coil and may extend away from the first coil toward the distal end of the first coil. In one embodiment, the second coil may be connected to the first coil near the distal end of the first coil, and the second coil may extend side by side in contact with the first coil in a distal region, and the second coil may split away from the first coil toward the proximal end of the first coil.

[0024] The systems herein may include a docking device having one or more coils or coiled portions connected to each other, for example, a docking device that is the same or similar to the docking devices described above or elsewhere in this disclosure. For example, the docking device of the system may have a first coil and a second coil connected at at least one point. The system(s) may also have a replacement valve, for example, a replacement valve as described above or elsewhere in this disclosure. For example, a replacement valve having an expandable frame and a plurality of leaflets. In the expanded configuration, the replacement valve may be configured to apply an outward pressure to the docking device that is sufficient to maintain a stable position of the replacement valve within the interior space of the docking device and / or relative to the native valve anatomy (e.g., native annulus, native leaflets, etc.). As described above, when deployed / implanted, some of the native anatomical structures (e.g., native leaflets, chordae tendineae, etc.) may be captured or squeezed between the docking device and the replacement valve.

[0025] Also described herein are methods (e.g., methods of replacing a native valve, methods of treating a patient, methods of implanting a docking device at a native heart valve, etc.). The methods herein may include obtaining a docking device, e.g., obtaining any docking device disclosed above or elsewhere in this disclosure. For example, the docking device includes a flexible tubular body having a distal end, a proximal end, a first lumen therethrough, and a second lumen therethrough. The method(s) may include inserting a delivery catheter through the vasculature and / or one or more chambers of the heart, and / or positioning the distal end of the delivery catheter at a first location in the circulatory system (e.g., in the vasculature or in a chamber of the heart (such as the left atrium, right atrium, etc.)). (One or more) of the methods may include advancing a docking device (e.g., all or a portion of a docking device; a distal end of a docking device; etc.) from within a delivery catheter such that the distal end is advanced through or between native valve leaflets (e.g., mitral valve leaflets, tricuspid valve leaflets, etc.) and, if applicable, around some or all of the chordae tendineae that may be present, and positioning the distal end of the docking device at a second location in the circulatory system (e.g., in the vasculature or in a second chamber of the heart (such as the left ventricle, right ventricle, etc.)).

[0026] A first coil, which may be identical or similar to other coils described herein (e.g., comprising a plurality of turns and having a first diameter), can be inserted into (e.g., fully or partially within) a first lumen of a docking device comprising one or more lumens, such that the tubular body adopts a first configuration. Inserting the first coil into the first lumen can occur before or after advancing the tubular body from within a delivery catheter. In cases where the first coil is inserted into the first lumen before advancing the tubular body from within the delivery catheter, at least a portion of the tubular body and at least a portion of the first coil can be advanced together between the native valve leaflets and positioned in a second location (e.g., in a second chamber of the heart). Furthermore, inserting the first coil into the first lumen can occur before or after positioning the distal end of the delivery catheter into the first chamber. Optionally, the first coil can be pre-loaded (e.g., packaged) within the tubular body, such that an end user or healthcare professional does not need to insert the first coil into the tubular body. If pre-loaded, the first coil can be permanently or removably attached or disposed within the tubular body.

[0027] The method(s) may include inserting a second coil having a second diameter (which may be the same or similar to other coils described in this disclosure) into a second lumen of the tubular body or docking device such that at least a portion of the tubular body adopts a second configuration.

[0028] The method(s) may include releasing the proximal end of the docking device to a first position (eg, in a first chamber such as the left atrium, right atrium, etc.) This may be accomplished, for example, by proximally retracting the delivery catheter relative to the docking device.

[0029] The method(s) may include inserting a replacement valve into an interior space defined by the docking device / tubular body (e.g., when the docking device / tubular body is in the second configuration). The replacement valve may be radially expanded until a retaining force exists between the replacement valve and the docking device that maintains the replacement valve in a stable position relative to each other and / or relative to native anatomical structures (e.g., one or more of the native valve, native annulus, native leaflets, etc.).

[0030] The method(s) (e.g., a method of replacing a native valve, a method of treating a patient, a method of implanting a docking device at a native heart valve, etc.) may also include steps for implanting one of the docking devices disclosed herein, the docking device having one or more coils or coiled portions connected to each other (e.g., as discussed above and elsewhere in this disclosure). The steps used may include steps that are the same or similar to the steps discussed above or elsewhere in this disclosure. The method(s) may include obtaining a docking device. For example, the docking device may have a first coil and a second coil, the first coil having a plurality of turns and the second coil having a plurality of turns, wherein a portion of the first coil is in contact with a portion of the second coil.

[0031] The method(s) may include positioning a distal end of a delivery catheter at a first location in the circulatory system (e.g., in the vasculature or in a first chamber of the heart (such as the left atrium, right atrium, etc. of the heart)). The delivery catheter may include a docking device in a first straightened configuration. The docking device may be advanced such that the distal end of at least the first coil is advanced through the mitral valve leaflets, if applicable, around some or all of any chordae tendineae that may be present, and positioned at a second location in the circulatory system (e.g., in the vasculature or in a second chamber of the heart (such as the left ventricle, right ventricle, etc.)). The first and second coils of the docking device may have a preset shape of at least one full or partial circular turn. The first coil may have a first diameter, and the second coil may have a second diameter. The method(s) may also include releasing the proximal end of the docking device at the second location (e.g., the first chamber, the left atrium, the right atrium, etc.).

[0032] The method(s) may further comprise inserting or positioning the replacement valve within the interior space defined by the docking device or tubular body in the second configuration. The method(s) may comprise radially expanding the replacement valve until a retaining force exists between the replacement valve and the docking device that maintains the replacement valve in a stable position. The connectivity of the coils of the docking device may be the connectivity of the coils of any embodiment described herein.

[0033] The various features and characteristics of the systems and apparatus described elsewhere in this disclosure may be included in the systems and apparatus described herein. Similarly, the steps of the procedures / methods described elsewhere in this disclosure may be included in the methods described herein.

[0034] Valve replacement at the mitral valve site, as well as at other native valve sites, can be accomplished using a coiled docking device that is first implanted at the native valve site for docking an expandable heart valve therein. Such a coiled anchor or docking device provides a more stable base into or against which the prosthetic valve can expand. Thus, embodiments of the present invention provide a more robust way to implant a replacement heart valve, even at sites where the annulus itself is non-circular or otherwise variable in shape. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] Other features and advantages of the present invention will become apparent from the description of the embodiments using the accompanying drawings. In the drawings:

[0036] Figure 1 shows a schematic cross-sectional view of a human heart;

[0037] Figure 2 shows a schematic top view of the mitral valve annulus of the heart;

[0038] Figure 3 shows a cross-sectional view of a portion of a heart during delivery of an exemplary coil-shaped docking device to the native mitral valve annulus of the heart;

[0039] Figure 4 A cross-sectional view of a portion of the heart is shown, wherein Figure 3 The exemplary docking device shown in FIG is positioned at the native mitral valve annulus after delivery;

[0040] Figure 5 A cross-sectional view of a portion of the heart is shown, wherein Figure 3 and Figure 4 The docking device shown in is positioned at the native mitral valve annulus and the prosthetic valve is positioned in and retained by the docking device at the native mitral valve annulus;

[0041] Figure 6 shows an exploded perspective view of an exemplary coil-shaped docking device for a prosthetic valve;

[0042] Figure 7 Shown Figure 6 A cross-sectional view of the tubular body of the docking device;

[0043] Figure 7A shows a cross-sectional view of an exemplary embodiment of a docking device;

[0044] Figure 8 Shown Figure 6 A top perspective view of the docking device, wherein the docking device exhibits a first dimension;

[0045] Figure 9 Shown Figure 6 a perspective view of a docking device, wherein a wire is partially inserted into the tubular body of the docking device during adjustment of the docking device from a first size to a second size;

[0046] Figure 9A A perspective view showing a docking device and anchoring member;

[0047] Figure 10 Shown after the docking device has been adjusted to the second size Figure 6 A top perspective view of a docking device;

[0048] Figure 11 shows a perspective view of an exemplary docking device;

[0049] Figure 11A A cross-sectional view of a portion of the heart is shown, wherein Figure 11 The docking device is positioned at the native mitral annulus;

[0050] Figure 12 shows a perspective view of an exemplary docking device;

[0051] Figure 12A A cross-sectional view of a portion of the heart is shown, wherein Figure 12 The docking device is positioned at the native mitral annulus;

[0052] Figure 13 shows a perspective view of an exemplary docking device;

[0053] Figure 14 shows a perspective view of an exemplary docking device; and

[0054] Figure 15 An exemplary docking arrangement including a high friction covering is shown. DETAILED DESCRIPTION

[0055] Disclosed herein are various anchoring or docking devices that can be used in conjunction with the implantation of an artificial heart valve at the native valve annulus to help more securely implant the artificial heart valve at the implantation site. Anchoring or docking devices according to embodiments of the present invention provide a circular and / or stable ring or docking area at the implantation site where an artificial valve having a more circular cross-section (e.g., a cylindrical valve frame or stent) can be expanded or otherwise implanted. Some embodiments of the docking devices also include, for example, features that help to more easily advance the docking device around various anatomical features at or around the native valve, better maintain a desired position of the docking device prior to delivery of the artificial valve, and / or increase or otherwise improve the retention of the artificial valve after the artificial valve has been implanted with the docking device. By providing such a docking device, a replacement valve can be more securely implanted and retained at any of a variety of native valve annuities, including at the mitral valve annulus.

[0056] First, briefly refer to Figure 6 and Figure 8 , an exemplary coil-shaped anchoring or docking device 1 includes a coiled body 10 having a plurality of turns extending around a central axis of the docking device 1. At least a portion of the coiled body 10 of the docking device 1 extends helically, wherein the turns are generally circular and have substantially equal inner diameters. The turns of the coiled body 10 form an elongated interior space 12 that serves as a landing area or holding area for holding and retaining a prosthetic heart valve when the corresponding components (e.g., the anchoring or docking device and the prosthetic valve and / or any other components used) are implanted at the valve site, such as in, for example, Figure 5 . Optionally, the turns can be circular, elliptical, oval, or other shapes prior to implantation of the replacement heart valve. The docking device can have various numbers of coil turns. For example, the number of functional coil turns in the center can range from slightly more than half a turn (e.g., half a turn) to 5 turns (e.g., 5 full turns) or more, or from one full turn to 5 turns. In an embodiment with three full turns, there can be an additional half turn in the lower ventricular portion of the docking device. In one embodiment, there can be a total of three full turns in the docking device. In the upper atrial portion of the docking device, there can be half to three-quarters of a turn or more. While providing a range of turns, the size of the coil can also be varied to maintain adequate retention as the number of turns in the docking device decreases. There can be one or more coils in a first chamber of the heart (e.g., right or left atrium, etc.) and / or one or more coils in a second chamber of the heart (e.g., right or left ventricle, etc.).

[0057] The docking device 1 can be positioned within a native valve such that at least a portion of the coiled body 10 extends away from either side of the native valve or the annulus of the native valve. In mitral or tricuspid valve applications, a portion of the coiled body 10 is located in the atrium, while a portion of the coiled body 10 is located in the ventricle. In this manner, a prosthetic valve retained in the docking device 1 can be implanted in approximately the same position as the native valve, while optionally being supported on both sides of the native valve or the annulus of the native valve.

[0058] Thus, at least a portion of the docking device 1 passes through the native valve in one direction or another (e.g., from the ventricle to the atrium, from the atrium to the ventricle, etc.). Due to the coiled or spiral shape of the docking device 1, in some embodiments, the front or distal end 2 of the docking device 1 can be rotated or inserted through the native valve and into the desired position before implanting the artificial valve. For example, for mitral valve applications, the docking device 1 can be delivered to the mitral valve position via one of a variety of entry sites, for example, transatrially through the left atrium, transseptally through the atrial septum, or via one of a variety of other known entry sites or procedures. In other embodiments, the docking device 1 can be inserted transapically or in a retrograde manner. For example, for tricuspid valve applications, the docking device 1 can be delivered using an entry site to the right atrium (e.g., from the IVC or SVC into the right atrium) and / or the right ventricle.

[0059] Figure 3 An exemplary implantation is shown at the mitral valve via a transseptal delivery approach, wherein an incision or puncture is made in the atrial septum and the guide sheath 400 and / or delivery catheter 410 is advanced through the septum and into the left atrium of the patient's heart. In an exemplary procedure, the guide sheath 400 and / or delivery catheter 410 may first be introduced into the patient's venous system via a percutaneous puncture and / or through a small surgical incision (e.g., in the patient's groin), and then the guide sheath 400 and / or delivery catheter 410 is advanced through the venous system to the right atrium. For an exemplary tricuspid valve procedure, the anchoring or docking device 1 may be delivered from the right atrium to the tricuspid valve location, for example, by passing a portion of the docking device 1 through the native valve or commissures of the native valve. For an exemplary mitral valve procedure, as Figure 3As shown, the distal end of the delivery catheter 410 can pass from the right atrium through the atrial septum and be positioned in the left atrium, with the distal opening of the delivery catheter 400 positioned just above the plane of the mitral valve near the desired access point (e.g., the commissure) through which the distal end 2 of the docking device 1 will be advanced into the left ventricle. In some procedures, the distal end of the delivery catheter 410 is positioned and directed toward the commissures A3P3 of the native mitral valve so that the docking device 1 can be advanced clockwise (i.e., as viewed in the direction of blood flow or in the inflow to outflow direction) through the commissures AA3P3 into the left ventricle. Other embodiments of the docking device can be coiled or bent in the opposite direction and instead advanced counterclockwise through the commissures A3P3 into the left ventricle. In other methods, the access point can alternatively be the commissures A1P1 or any other portion of the opening defined by the mitral annulus, and advancement can be clockwise or counterclockwise, as appropriate. Furthermore, the various docking devices and coils described herein may be configured to rotate / wind in either a clockwise or counterclockwise direction, even though shown in the figures as winding in only one direction.

[0060] In the case of using a guide sheath 400, the guide sheath can be introduced and positioned at a desired location (e.g., through the septum as shown) before the delivery catheter 410, and the delivery catheter 410 can then be inserted through the inner lumen of the guide sheath 400 and thereby guided through the vasculature, the right atrium and / or the left atrium, or the guide sheath 400 and delivery catheter 410 can be introduced and positioned simultaneously.

[0061] When the docking device 1 is retained in the delivery catheter 410, the docking device 1 can be straightened for easier manipulation through the delivery catheter 410 and for a smaller delivery profile. Thereafter, when the docking device 1 is pushed out of the delivery catheter 410, the docking device 1 can return to its original coiled or curved shape (e.g., a preset shape memory shape). The docking device 1 can exhibit such properties, for example, by being made of or including a shape memory material (e.g., NiTi or other shape memory polymers or alloys) and then being shaped to a desired curvature to which the docking device 1 returns during delivery. The distal end of the delivery catheter 410 can also exhibit a curved configuration, wherein the curvature is similar to that of the docking device 1, to facilitate the docking device 1 being pushed out of the delivery catheter 400. The distal end 2 of the docking device 1 is then passed through the native mitral annulus (e.g., at the commissures) and into the left ventricle, where the distal end is navigated to encircle the native leaflets, chordae tendineae, and any other desired mitral valve anatomy in the left ventricle, such that once the docking device 1 has been advanced to the desired location, any native anatomy encircled by the docking device 1 will be positioned within the interior space 12 of the docking device 1. In tricuspid or other valve procedures, similar steps may be taken, but based on valve anatomy navigation, for example, a delivery catheter may be positioned near an access point (e.g., the commissures) of the tricuspid valve, and the docking device may be deployed such that it rotates around or encircles the native anatomy of the tricuspid valve. The docking device is sufficiently flexible to be pushed through a straight catheter and sufficiently structural to provide adequate retention when deployed.

[0062] After the desired amount of the docking device 1 has been advanced into one chamber of the heart (e.g., the left ventricle, right ventricle, etc.), the remainder of the docking device 1 (e.g., the atrial side of the docking device 1 in the illustrated embodiment) can then be released into another chamber of the heart (e.g., the left atrium, right atrium, etc.). This can be accomplished, for example, by rotating the distal end of the delivery catheter 410 in a direction opposite to the direction of advancement of the docking device 1 (not shown) so that the proximal side (e.g., the atrial side) of the docking device 1 can be released without affecting the position of the distal side (e.g., the ventricular side) of the docking device 1. If the docking device includes a stabilizing turn / coil at the proximal side of the docking device, the stabilizing turn / coil can be released so that it contacts the surrounding anatomy (e.g., so that it contacts the wall of a chamber of the heart, the wall of the atria, the wall of the circulatory system or vasculature, etc.) to stabilize or retain the docking device in the desired position / location prior to implantation of the prosthetic valve or THV.

[0063] Other methods can also be used to release the atrial side of the docking device 1 from the delivery catheter 400. For example, if the docking device 1 is attached to the delivery catheter by sutures, it can be released from the delivery catheter 400 by releasing the suture lock as described in U.S. Patent Application No. 14 / 372,953, which is incorporated herein by reference in its entirety. For example, a long release suture looped through an opening on the proximal end of the docking device can be cut and then pulled to release the delivery catheter from the docking device once the docking device is properly positioned. The suture can be cut or pulled through the loop to release the docking device from the delivery catheter.

[0064] Figure 4 A cross-sectional view of a portion of a patient's heart is shown with the docking device 1 in place at the mitral valve location and prior to delivery of an artificial heart valve. In some procedures, during this time, the native mitral valve can still continue to operate essentially normally (or better, for example, if the docking device helps improve coaptation) to keep the patient stable. Similarly, at a similar stage of implantation at the tricuspid valve location, the native tricuspid valve can still continue to operate essentially normally (or better, for example, if the docking device helps improve coaptation). Thus, the procedure can be performed on a beating heart without the need for a heart-lung machine, which also allows the practitioner more time and flexibility to implant the valve prosthesis without risking the patient being in or falling into a hemodynamically compromised situation that would result if too much time elapsed between implantation of the docking device 1 and the subsequent valve implantation.

[0065] With respect to the same or similar embodiments of the docking device 1 having one or more wires / coils that can be inserted into the tubular body 10 (or having a tubular coil 60 inserted around the coil 50, etc.), the steps described below with respect to these embodiments can be used. For example, a first wire / coil 20 (e.g., a wire of smaller thickness with a larger coil diameter) can be inserted into the tubular body 10 to help properly position the docking device within the native valve / anatomy, and a second wire 30 / coil (e.g., a wire of larger thickness with a smaller coil diameter) can later be inserted into the tubular body 10 to adjust the size of the functional coil or area for receiving the prosthetic valve, etc.

[0066] Figure 5A cross-sectional view of a portion of the heart is shown, in which the docking device 1 and the artificial valve 40 are both implanted at the mitral valve position. Similar arrangements can also be made at other valve positions, such as at the tricuspid valve. The artificial valve 40 can be, for example, an expandable transcatheter heart valve (THV) that is delivered through a catheter in a radially collapsed state and expands after being advanced to a desired position in the interior space 12 of the docking device 1. In a procedure / method using a guide sheath 400, the guide sheath 400 can form a channel through which other devices (e.g., a delivery catheter for delivering an artificial valve or THV, etc.) can also be delivered or navigated, for example, after the delivery catheter 410 for the docking device 1 is retracted and removed from the guide sheath 400. However, optionally, the guide sheath can also be retracted and removed before the artificial valve or THV delivery catheter is navigated to the desired position for delivering the artificial valve or THV. Such a THV or artificial valve 40 can have an expandable frame structure 41 that accommodates multiple valve leaflets 42. The expandable frame 41 of the prosthetic valve 40 can be balloon-expandable, can be self-expanding (e.g., by being made of a shape memory material such as NiTi), or can be expandable in one or more of a variety of other mechanical or non-mechanical ways (e.g., via balloon expansion, etc.). There are many types of expandable prosthetic heart valves that would benefit from being anchored within the docking device 1, including those manufactured by Edwards Lifesciences of Irvine, California, Medtronic of Minneapolis, Minnesota, and St. Jude Medical of Minneapolis, Minnesota. Upon expansion, the expandable frame 41 pushes radially outward and applies a radially outward force to the docking device, and the docking device applies a radially inwardly directed reaction force to the prosthetic valve 40. In addition, some native anatomical structures (e.g., native leaflets, chordae tendineae, mitral valve anatomy, tricuspid valve anatomy, etc.) surrounded and held in the interior space 12 by the docking device 1 are pinched or compressed between the docking device 1 and the outer surface of the prosthetic valve 40 when the valve frame 41 expands. These interactions and opposing forces between the various components and anatomical features hold the entire assembly securely in place at the mitral valve position or other valve position. In non-circular embodiments of the docking device (e.g., having elliptical, oval, etc. coils), expansion of the circular prosthetic valve can cause the docking device coils to become more circular or more round in shape as they conform to the shape of the prosthetic valve. The implantation procedure is then complete, and the delivery tool can be removed from the patient.

[0067] As shown above, in order to position and anchor itself to the native anatomy (e.g., mitral valve anatomy, tricuspid valve anatomy, etc.) before and after implantation of the prosthetic valve 40, the docking device 1 relies on navigating around and encircling the native leaflets, chordae tendineae, and / or other portions of the native anatomy (e.g., mitral valve anatomy, tricuspid valve anatomy, etc.), which in turn helps to maintain the docking device 1 at a desired height and position of the native valve annulus (e.g., mitral valve annulus, tricuspid valve annulus, etc.). The mitral valve anatomy of an average patient spans approximately 50 mm along the major axis and approximately 38 mm along the minor axis. In order to adequately encircle the mitral valve anatomy (or other valve anatomy), the docking device can have a size and dimension similar to that of the mitral valve anatomy (or other valve anatomy), or be adjustable during initial navigation around the mitral valve anatomy or other valve anatomy (e.g., having an articulatable tip, adjustable size and / or shape, etc.), or both. On the other hand, in order to effectively retain the expandable artificial heart valve in the docking device, the inner diameter of the internal space 12 of the docking device should be small enough (for example, smaller than the outer diameter of the artificial valve 40 in its unbiased expanded state, which is approximately 29 mm in an example) to generate sufficient retaining force between the docking device and the artificial valve.

[0068] Additionally, it can also be beneficial to deploy and maintain the docking device 1 at a relatively high position at the native annulus. For example, in the mitral valve application described above, deploying the docking device 1 as high as possible in the left ventricle also allows the prosthetic valve 40 to remain high in the left ventricle.

[0069] refer to Figure 6 , an exemplary docking device 1 may include a body 10, a first wire / coil 20 and a second wire / coil 30. The body 10 is formed of an elongated tubular structure. In some embodiments, the body 10 itself can be made to have an inherent curvature or curl, while in other embodiments, the body 10 can be formed generally straight. In each embodiment, the body 10 is made of or includes a flexible or bendable material, such as ePTFE, so that the insertion of a more rigid core (e.g., wire / coil 20, 30) into the body 10 will cause the body 10 to take on or adapt to the shape of the core. In some embodiments, the body 10 is constructed as an ePTFE extrusion formed with one or more lumens extending longitudinally therethrough. The cross-sectional diameter of the body 10 can be in the range of 0.4 mm to 0.85 mm, or more specifically in the range of 0.6 mm to 0.85 mm, or in an exemplary embodiment, 0.8 mm. With reference to Figure 7, the body 10 has a dual lumen arrangement having a first lumen 14 and a second lumen 16 that are aligned in one direction in cross section, but in other embodiments, the lumens 14, 16 can be positioned and extend through the body 10 in other arrangements. The lumens 14, 16 can be formed during the extrusion process of the body 10, or can be cut into the body 10 after the body 10 has been formed. Lumen 14 is smaller than lumen 16 (but other sizes and the same size are also possible). The diameter of the smaller lumen 14 can be in the range of 0.5 mm to 4 mm. The diameter of lumen 16 can be in the range of 0.5 mm to 4 mm and has a larger cross-sectional diameter than lumen 14. In one embodiment, the body 10 has a diameter of 2.2 mm, while lumen 14 has an inner diameter of 0.6 mm and lumen 16 has an inner diameter of 1.0 mm. More generally, the size and shape of one or more lumens formed in the body 10 will be set to receive the corresponding wire (e.g., wire / coil 20, 30) suitable for insertion into the body 10. The wire can have a cross-sectional diameter or thickness of 0.5mm to 4mm, and the diameter / thickness of the wire can be less than the cross-sectional diameter / thickness of the lumen into which it will be inserted. In one embodiment, the cross-sectional diameter / thickness of the wire 20 that can be inserted into the lumen 14 can be a diameter / width of 0.5mm to 4mm, and the cross-sectional diameter / thickness of the wire 30 can be a diameter / width of 0.5mm to 4mm to be inserted into the lumen 16. The cross-sectional diameter / size of each lumen can be at least as large or larger than the cross-sectional diameter of the wire inserted into the lumen. Optionally, the lumen can stretch or expand to accommodate a larger wire cross section.

[0070] Return Reference Figure 6 The docking device 1 further comprises a first wire / coil 20 and a second wire / coil 30. The main body 10 and the wires 20 and 30 are connected to each other. Figure 630 is shown as rotating or winding in a counterclockwise direction (or in an inflow to outflow direction) from top to bottom, but the body 10 and the wires 20, 30 can also be configured to rotate / wind in a clockwise direction. The wires 20, 30 can both be made of or include one or more shape memory materials, such as NiTi, and the shape can be set to, for example, form coils with curvatures of different sizes. Other shape memory metals can be used. Non-shape memory materials, such as stainless steel, can also be used. The shape of the first wire 20 is set to form a coil having a larger inner curvature or coil diameter than the second wire 30, for example, in the range of 20mm to 40mm, or more specifically 35mm, and can be made to have a thinner cross-sectional thickness than the second wire 30, for example 0.5mm, or alternatively or in addition to having a thinner cross-section, can be formed with a lower elastic modulus than the second wire 30. At the same time, the shape of the second wire is set to form a coil having a smaller inner curvature or coil diameter than the first wire 20, for example, in the range of 15 mm to 30 mm, or more specifically, in the range of 20 mm to 30 mm, or more specifically 25 mm, while having a larger cross-sectional thickness than the first wire 20, for example 0.8 mm, and / or a higher elastic modulus.

[0071] Now refer to Figure 8 , the body 10 of the docking device 1 has only the first wire 20 inserted therein, and the first wire 20 extends through, for example, the lumen 14, while the lumen 16 remains empty. This arrangement defines the first stage, or configuration, of the docking device 1. In some embodiments, the first wire 20 can be inserted from either end of the body 10, while in other embodiments, one end of the lumen 14 can be closed, allowing the first wire 20 to be inserted only from one side of the body 10. The initial insertion of the first wire 20 through the body 10 causes the body 10 to substantially assume the shape and size of the first wire 20, or to assume a shape having a diameter that is smaller than the initial diameter of the body, but which may be equal to, larger than, or smaller than the initial diameter of the first wire 20. In one example, the body 10 in this example assumes a coil shape having an inner diameter of approximately 35 mm. This larger initial size of the docking device 1 is maintained in a desired position relative to the native valve during advancement of the docking device 1 around the native anatomy (e.g., mitral valve anatomy, tricuspid valve anatomy, etc.) to facilitate easier navigation around and capture of the native anatomy (e.g., mitral valve anatomy, tricuspid valve anatomy, etc.). The thinner thickness and / or lower elastic modulus of the wire 20 also allows the docking device 1 to be more flexible in the first configuration, which also makes it easier to navigate the distal end of the docking device 1 through and / or around the leaflets, chordae tendineae, and / or other anatomical geometries.

[0072] In some embodiments, the proximal region of the first wire 20 can be further shaped to form a coil having a larger diameter (e.g., 55 mm (not shown)) than other portions of the first wire 20. This enlarged proximal region of the first wire 20 will correspond to the portion of the docking device 1 that is positioned in a first chamber of the heart (e.g., left atrium, right atrium, etc.) when the docking device 1 is advanced to a desired position at the native valve annulus (e.g., mitral valve annulus, tricuspid valve annulus, etc.) and, after placement, can help reduce or prevent sliding or other displacement of the docking device 1 into a second chamber of the heart (e.g., into the left ventricle, right ventricle, etc.), for example, by seating against and forming an abutment against the floor of the first chamber (e.g., left atrium, right atrium, etc.) or by pressing against a side wall of the first chamber (e.g., lateral atrial wall, etc.).

[0073] After docking device 1 has been advanced to a desired position around native anatomy (e.g., mitral valve anatomy, tricuspid valve anatomy, etc.) while in the wider first configuration, second wire 30 can be inserted into body 10, e.g., through the proximal opening of larger lumen 16, to adjust docking device 1 to the smaller second state or configuration. The first wire can be removed from body 10 before or after insertion of the second wire, or the first wire can remain within body 10 along with the second wire. With both the first and second wires within body 10, due to the greater thickness and / or higher elastic modulus of second wire 30, the tension applied to body 10 by second wire 30 is greater than and overcomes the tension applied to body 10 by first wire 20. As a result, body 10 is pushed by second wire 30 to assume or more closely approximate the smaller shape-setting size of second wire 30. Consequently, based on the shape-setting size of second wire 30, interior space 12 of docking device 1 assumes a smaller functional diameter (which may be equal to, greater than, or less than the diameter of the second coil; for example, it may exhibit an inner diameter of approximately 25 mm).

[0074] Figure 9 1 shows a perspective view of the docking device 1 wherein the second wire 30 has been partially inserted into the body 10 during adjustment or conversion of the docking device 1 from a first configuration to a second configuration. Figure 9 As can be seen in FIG, the size of the top or proximal portion 18 a of the body 10, into which the second wire 30 has been advanced, has been lowered or reduced to a smaller diameter. At the same time, the size of the bottom or distal portion 18 b of the body 10 remains at a larger diameter corresponding to the size of the first wire 20, since the second wire 30 has not yet reached and extended through the distal portion 18 b.

[0075] Figure 10A top perspective view of the docking device 1 is shown, wherein the second line 30 has been fully inserted into the body 10 and wherein the docking device 1 has thus been fully adjusted to the second size configuration. In one example, the docking device 1 exhibits a coiled shape with an inner diameter of approximately 25 mm. Also, for size comparison, Figure 10 Also shown is a dashed line 22 to illustrate the original coil size of the docking device 1 when the docking device 1 is in the first size configuration (eg, a coil size of 35 mm).

[0076] In other embodiments, the coil of the docking device can be changed in shape by attaching a tension wire to the distal end, as described in U.S. Provisional Patent Application Serial No. 62 / 395,940 and U.S. Patent Application No. 15 / 682,287, both of which are incorporated herein by reference in their entireties. Continuing to pull the tension wire increases the tension and tightens the coil of the docking device.

[0077] As described above, in order for the prosthetic heart valve to generate a sufficient amount of retaining force and / or frictional force against the docking device 1 to achieve a secure hold between the components, both relative to each other and relative to the native valve anatomy, the diameter of the docking device 1 (or the diameter of the docking device's interior space 12 or functional turns / coils) should be smaller than the outer diameter of the prosthetic valve in its expanded state. The relative diameters of the valve and docking device 1 (e.g., interior space 12 or functional turns / coils) are important because they directly control the retaining force generated between the components when the valve is expanded, with smaller coil diameters of the docking device 1 generally resulting in greater retaining force between the components. Therefore, a second wire of appropriate size should be selected based on the size of the valve to be implanted. In one embodiment, a second wire 30 having a diameter of 25 mm can be used with a replacement valve having an expanded diameter of approximately 29 mm, for example. To achieve even greater retaining force, a second wire of smaller diameter, such as one having an interior space diameter of 23 to 24 mm, can be used. Furthermore, in other procedures using valves of different sizes (e.g., based on different patient anatomy or needs), other second wires of different sizes may be selected and used instead.

[0078] By inserting two separate wires 20, 30 into the body 10, the spring force of the entire docking device 1 is also increased when the docking device 1 is in the second configuration (e.g., equal to the sum of the spring forces of the separate wires 20, 30), for example, when compared to other docking devices having only a single wire core. By better maintaining the spring shape of the combined docking device 1, the docking device 1 can also improve the retention of the docking device 1 in a desired position relative to the native valve before the prosthetic valve is delivered, for example, by more tightly gripping the leaflets and other anatomical structures between the coils of the docking device and / or between the coils of the docking device and the prosthetic valve, thereby reducing unintentional displacement of the docking device 1 (e.g., toward the left ventricle or another chamber).

[0079] Similar to the discussion above regarding first wire 20, in some embodiments, the proximal region of second wire 30 can be further shaped to have a larger diameter than other portions of second wire 30 (not shown). This can be done to further maintain docking device 1 in place and prevent migration of docking device 1 (e.g., into the left ventricle or an undesired location) after placement. For example, the proximal region of second wire 30 can be shaped to have a 55 mm internal volume or functional diameter to match the 55 mm diameter of a similarly enlarged proximal region of first wire 20, and will function similarly, with the enlarged proximal region(s) positioned in the left atrium and forming an abutment against the floor and / or wall of a first chamber of the heart (e.g., left atrium, right atrium, etc.) to prevent further migration of docking device 1 into a second chamber (e.g., left ventricle, right ventricle, etc.). In some embodiments, docking device 1 can have only one wire (e.g., wire 20 or 30) with an enlarged proximal region, without the other. In some embodiments, the docking device 1 may have only one lumen, and each of the wires (e.g., two wires) participates sequentially in the same lumen (e.g., one wire may be removed and another inserted, or the second wire may be inserted after the first wire).

[0080] Various other modifications can be made to the above-described embodiments while still providing a two-stage adjustable docking device that facilitates both easier delivery of the docking device itself and a more secure docking site for the prosthetic valve. Figure 7AAs shown, rather than having a body with two lumens for holding two separate wires, similar performance can be achieved by first advancing the wire core 50 to the desired position at the native valve site and then advancing a stiffer tube 60 over the wire. In such an example, the wire can be made of or include a shape memory material such as NiTi and can be shaped to have a relatively large coil diameter for initial delivery to the valve site. The wire can also be made relatively thin and / or flexible. At the same time, the tube can also be made of or include a shape memory material such as NiTi and can be shaped to have a smaller coil diameter than the wire and can be made thicker and / or stiffer than the wire so that the shape of the tube can overcome any elasticity of the shape of the wire. After the wire is advanced to the desired position at the valve site, the tube can be slid over the wire or otherwise advanced to reduce the size of the coil assembly so that the interior space defined by the coiled shape of the combined docking device presents a smaller final inner diameter for receiving the prosthetic valve.

[0081] In one embodiment, a tube can be first advanced at the valve site, and then a wire can be inserted into the tube to reduce the size of the combined assembly. The tube can be made of, for example, or include a thermoplastic that is coextruded with an ePTFE lumen and can assume a shape that allows for easier maneuverability around the mitral valve or other valvular anatomical structures. After the tube is advanced to the desired position at the valve site, a wire made of, or including, a shape-memory material, such as NiTi, can be inserted into the tube. The wire can be shaped as a coil with a relatively smaller diameter than the tube and can be made thicker and / or otherwise stiffer so that, when inserted into the tube, it is sufficiently strong to influence the tube's shape and reduce the combined docking device to a smaller coil size for receiving a prosthetic valve. The diameter of the circular turns of the second coil inserted into the tube of the docking device can be smaller than the diameter of the circular turns of the first coil. The diameter of the first coil wire can range from just as large as the diameter of the second coil to ten times the diameter of the second coil. The diameter of the first coil wire can be twice, four times, or ten times the diameter of the second coil.

[0082] Once the replacement valve has been expanded, the force applied by the coils is compared to the outward force applied by the replacement valve. The replacement valve may be an Edwards SAPIEN 3 transcatheter heart valve, or it may be another replacement heart valve. The radial force of the docking device may be five (5) to twenty (20) times the radial force of the expanded replacement valve. The radial force of the docking device may be five (5) to ten (10) times the radial force of the expanded replacement valve.

[0083] The sizes and shapes of the tubes, wires, and other components described in the above embodiments are examples only, and different sized components may be selected for advancing the docking device to the valve site and for final docking of the replacement valve based on, for example, different sized patient anatomy and the selected replacement valve, as well as other factors.

[0084] In embodiments of the present invention in which the docking device is deployed in a two-stage process similar to that described above, delivery of the docking device can be more easily facilitated and performance of the docking device can be improved. Delivering the distal end of the docking device to one chamber of the heart (e.g., the left ventricle, right ventricle, etc.) while the docking device is in a larger and more flexible first configuration allows for easier navigation through and / or around native valve anatomy. The docking device is then adjusted to a second configuration in which the docking device has a smaller inner diameter and / or increased spring force, providing a stronger and more secure docking site for the prosthetic valve that is expanded and / or otherwise retained in the docking device.

[0085] As described with respect to the alternative embodiments of the docking device 1 above, in some cases, the atrial or proximal side of the coiled or spiral docking device can be enlarged, for example, to a size similar to the anatomy of the atria. The proximal or atrial coil can be enlarged to a range of 30 mm to 80 mm, or a range of 30 mm to 75 mm, or approximately 55 mm to prevent or inhibit movement of the docking device toward the left or right ventricle. The enlarged portion of the docking device can abut the floor of the atrium (e.g., the left or right atrium) or push against the lateral atrial wall, thereby stabilizing or stabilizing the docking device relative to the native anatomy (e.g., mitral valve anatomy, tricuspid valve anatomy). The atrial or proximal portion of the coil can be referred to as a stabilizing turn / coil or an atrial turn / coil.

[0086] However, in embodiments where the primary coil is enlarged at the atrial or proximal end, such enlargement of the primary coil of the docking device may result in a less stable connection between the docking device and the prosthetic valve, e.g., due to a reduction in contact area between the components at least in the region where the docking device has the enlarged regions / turns. For example, a transcatheter heart valve having an expanded, unbiased diameter of 29 mm may be docked in a coiled anchor having an inner diameter of 23 mm to 24 mm to generate sufficient retention between the components after the replacement valve is expanded in the docking device. However, when a portion of the docking device is expanded to 55 mm, the enlarged portion of the docking device may no longer help retain the replacement valve therein.

[0087] Figure 11 shows a perspective view of an exemplary docking device, and Figure 11A Shown is the heart's native mitral valve annulus Figure 11Cross-sectional view of a docking device 100. The docking device 100 includes a distal or ventricular portion 110 comprised of a single coil and a proximal or atrial portion 120 having a first inner coil 122 and a second outer coil 124 (the second outer coil 124 being configured as a stabilizing turn / coil). The coils / turns of this docking device (and other docking devices described herein) can be configured to rotate / wind in a clockwise or counterclockwise direction. The inner coil 122 of the proximal portion 120 and the distal portion 110 together form the primary coil of the docking device 100, which has a substantially constant inner diameter and forms a docking site for a prosthetic valve. When using a 29 mm prosthetic valve for, for example, mitral valve replacement, embodiments of the docking device 100 can be formed with a small, substantially constant winding inner diameter of approximately 23 mm to 24 mm to tightly and securely hold the prosthetic valve after deployment. Other embodiments may have coils with inner diameters less than 23 mm or greater than 24 mm, depending on, for example, the size of the prosthetic valve and the amount of retention force required, among other factors.

[0088] At the same time, the outer coil 124 of the proximal portion 120 serves as a secondary coil from the primary coil to form a separate spiral or coil structure. The outer coil 124 extends around the outside of the inner coil 122 and extends radially outwardly wider than both the inner coil 122 and the distal portion 110 of the docking device 100. Figure 11A As can be seen in , both the outer coil 124 and the inner coil 122 are configured to extend into one chamber or atrium of the heart (e.g., the left atrium or the right atrium) when the docking device 100 is advanced to a desired position relative to a native valve (e.g., the mitral valve, the tricuspid valve), and are sized and shaped to be sufficiently large or wide to effectively serve as a transient anchoring and stabilizing mechanism (or stabilizing coils / turns) for the docking device 100 prior to delivery of the prosthetic valve. Figure 11 and Figure 11A In the embodiment of the present invention, the outer coil 124 is integrally formed with the inner coil 122 of the distal portion 110 and the proximal portion 120 and extends away from the main coil of the docking device 100 at or near the middle or center area of ​​the docking device 100, thereby forming a bifurcation / split portion 118 in the docking device 100.

[0089] In some embodiments, the location of the split / bifurcation portion 118 of the docking device 100 substantially corresponds to or can be just proximal to the portion of the docking device 100 that passes through the native valve (e.g., mitral valve, tricuspid valve, etc.) when the docking device 100 is delivered to the native valve. The larger or wider shape and size of the outer coil 124 can form a docking portion that inhibits or prevents advancement or displacement of the docking device 100 (e.g., toward the left ventricle, right ventricle, etc.). In some embodiments, the outer coil 124 can also be wide enough to push radially outward against the lateral portions of the atrial wall, thereby providing further stability to the docking device 100.

[0090] Figure 12 and Figure 12A The diagram shows Figure 11 and Figure 11A An embodiment similar to the embodiment in, but not as Figure 11 and Figure 11A Rather than being shown with a rectangular cross-section, the inner and outer coils 122, 124 in the proximal portion and the distal portion 110 are circular in cross-section.

[0091] Figure 13 A perspective view of an exemplary docking apparatus is shown. Figure 13 The docking device 200 in the embodiment may have Figure 11 、 Figure 11A 、 Figure 12 and Figure 12A The docking device 100 in FIG. 1 has the same or similar general overall geometry as the docking device 100 in FIG. 1 , but is constructed using a first coil 210 and a separate second coil 220 .

[0092] The first coil 210 serves as the main coil of the docking device 200 and may have a similar Figure 11 、 Figure 11A 、 Figure 12 and Figure 12A The size and shape characteristics of the primary coils of the docking device 100 in FIG. 2 are similar (e.g., the first coil 210 may have a substantially constant inner diameter of approximately 23 mm to 24 mm). The first coil 210 provides the primary docking site for the prosthetic valve and, therefore, may be made thicker and / or more rigid than the second coil 220.

[0093] Meanwhile, the second coil 220 serves as a secondary coil for the docking device 200 and begins at or near the distal or ventricular end 202 of the docking device 200 and is secured to or otherwise attached to the first coil 210. In the illustrated embodiment, both coils 210, 220 of the docking device 200 begin at approximately the same point at the distal end 202 of the docking device 200. In other embodiments, the two coils may not extend the same length in the distal direction; for example, the second coil 220 may not extend as far distally as the first coil 210. The second coil 220 then splits from the first coil 210 at or near the middle or center region of the docking device 200 and extends away from the first coil 210. The two coils 210, 220 can be connected together in various ways, such as by welding, adhesive or bonding, or heat shrinking. In another embodiment, the two coils 210, 220 can be from the same piece, with the second coil 220 cut from the primary piece, and the primary piece being the first coil. The second coil 220 is configured as a stabilizing coil / turn to temporarily anchor and stabilize the docking device 200 at the implantation site prior to delivery of the prosthetic valve. Because the second coil 220 does not serve as a docking site for the prosthetic valve, the second coil 220 can be constructed to be thinner and / or softer / pliable or floppy compared to the first coil 210. The additional flexibility in the second coil 220 can also potentially help to better stabilize the docking device 200, for example, by allowing the shape of the second coil 220 to better conform to the shape of the surrounding anatomical structure it contacts (e.g., to the atrial wall), and / or by acting as a damping element to prevent movement of the docking device 200 relative to the native annulus.

[0094] Figure 14 A perspective view of an exemplary docking apparatus is shown. Figure 14 The docking device 300 in FIG. 3 also has a first coil 310 and a second coil 320. The first coil 310 serves as the main coil of the docking device 300 and serves as the main docking site of the artificial valve. Figure 13 As seen in the docking device 200 in FIG. 1 , the first coil 310 of the docking device 300 may also be made thicker and / or more rigid than the second coil 320 .

[0095] Meanwhile, the second coil 320 serves as a secondary coil of the docking device 300 and is configured as a stabilizing coil / turn to temporarily anchor and stabilize the docking device 300 relative to the native valve prior to delivery of the prosthetic valve. However, unlike the previous embodiments, the second coil 320 is attached to the first coil 310 at or near the proximal or atrial end 304 of the docking device 300, wherein the proximal ends of the two coils 310, 320 may be crimped or welded together at a connecting portion or region 330, or otherwise connected to each other.

[0096] Furthermore, the second coil 320 is not connected to the first coil 310 and does not extend any appreciable distance along the length of the docking device 300 along with the first coil 310. Instead, the second coil 320 is split from the first coil 310 at or near the proximal end 304 of the docking device 300, with the two coils 310, 320 connected near the proximal end 304 of the docking device 300. From the proximal end 304 of the docking device 300, the second coil 320 extends in a coil or spiral shape toward the distal end 302 of the docking device 300 and extends radially outwardly wider than the first coil 310. The second coil 320 is axially shorter than the first coil 310 and has a distal end 322 that terminates as a whole at or near the middle or central region of the docking device 300. In some embodiments, the middle or central region of the docking device 300 may substantially correspond to the height at which the floor of one chamber or atrium of the heart (e.g., the left atrium or the right atrium) would be positioned when the docking device 300 is delivered to a native valve. In this manner, in some embodiments, the distal end 322 of the second coil 320 can abut the floor of the chamber or atrium (e.g., the left atrium or the right atrium) to prevent or hinder movement of the docking device 300 toward another chamber or chamber (e.g., the left ventricle or the right ventricle). Additionally, the second coil 320 can be made thinner and / or more flexible or floppy than the first coil 310, which may further help stabilize and / or dampen movement of the docking device 300 at the implantation site prior to delivery of the prosthetic valve.

[0097] About Reference Figure 13 and Figure 14 As described above, the docking devices 200 and 300, as well as other docking devices utilizing two separate coils, can have the same thickness or different thicknesses depending on the specific application of the coils, and in some embodiments, can also differ in material, cross-sectional shape, and / or other physical properties depending on the specific application and needs. Furthermore, the connection between the coils can be achieved by, for example, crimping with a crimping tube, by welding, by gluing, or by any other suitable connection or joining technique.

[0098] According to embodiments of a docking device with an integrated or connected dual coil, the secondary coil of the dual coil can help temporarily anchor and / or stabilize the docking device by pushing against or abutting the atrial floor and / or lateral atrial wall prior to expanding or docking the prosthetic valve in the docking device, thereby reducing relative movement between the docking device and the surrounding native tissue. In this way, abrasions and / or tears of the native valve leaflets and other valve anatomical structures caused by relative movement or friction between the native tissue and the docking device can be reduced or prevented. At the same time, with the dual coil, the primary coil of the dual coil (including the portion of the primary coil located in the left atrium) maintains and retains a smaller inner diameter, thereby continuing to provide an effective docking site for the prosthetic valve along the greater length of the docking device.

[0099] There are other ways to change the size of the docking device's coil. In another embodiment, the docking device can be a laser hypotube with a wire running through it, as described in U.S. Provisional Application Serial No. 62 / 395,940 and U.S. Patent Application No. 15 / 682,287, both of which are incorporated herein by reference in their entireties. In another embodiment, the coil can be a shape memory metal that changes shape when its temperature increases.

[0100] Various other modifications can also be made to the described embodiments. For example, the docking device can be covered with an additional layer, such as a fabric or textile, to reduce damage to native tissue. A cover can be included that is made of or includes a high-friction material, for example, to generate additional friction, thereby increasing the retention between the docking device and the docked prosthetic valve. Using a high-friction material for the cover provides an increased amount of friction between the valve and the cover to maintain the shape of the docking device and prevent the docking device from unwinding when the expandable valve is expanded in the docking device.

[0101] like Figure 15 As shown in FIG, cover 1180 can be made of one or more high-friction materials that can be placed over tubular body 1130. In one embodiment, cover 1180 is made of or includes a woven PET fabric. The ePTFE tubular body is porous, providing a cushioned, fill-type layer for struts or other portions of the expandable valve frame to dig into, improving the engagement between the valve and docking device 1100. Simultaneously, PET layer 1180 provides additional friction against the native valve leaflets when the prosthetic valve is expanded and struts or other portions of the valve frame exert outward pressure on docking device 1100. These features can work together to increase the radial force between docking device 1100 and the valve, thereby increasing retention and preventing unwinding of docking device 1100. In other embodiments, cover 1180 can be made of one or more other high-friction materials that similarly cover the tubular body of docking device 1100.

[0102] In other embodiments, the docking device 1 may further include a barb or anchor 90 (e.g. Figure 9A ), further increasing the holding force. The barbs or anchors 90 can be in the shape of small splints or hooks or other shapes that are used to maintain the docking device 1 in the appropriate position within the native tissue. In an exemplary embodiment, the barbs / anchors 90 extend radially outward from the outer surface and / or end of the tubular body of the docking device. Additionally, in some embodiments, the outer surface of the frame of the replacement valve can also be covered with cloth or other high friction material to further increase the friction between the docking device and the valve, thereby further reducing or preventing the docking device from unwinding. Once the replacement valve is expanded in the docking device 1100 and the resulting assembly begins to function as a combined functional unit, any tissue ingrowth can also be used to reduce the load on the combined valve and docking assembly.

[0103] The tubular body of some embodiments may also or alternatively be made of or include a material that promotes more rapid tissue ingrowth and may be configured to have a greater amount of surface area, such as with VALURE TM membrane to further enhance tissue ingrowth. The tubular body can be made of ePTFE and can be constructed to have a pore size of, for example, 30 microns so that blood cells can more easily anchor in and against its outer surface, for example, to promote tissue ingrowth after implantation. The size of the pores can be in the range of 30 microns to 100 microns to increase the surface area within which cells are embedded and increase tissue growth. In addition, ePTFE is also a very low friction material, which is useful for preventing or minimizing trauma to tissues in contact with it. Tissue growth can be promoted by using materials with a high surface area or by increasing the available surface area for ingrowth, and the increased surface area to promote tissue ingrowth can be imparted / included in a variety of ways, for example, using pores, braided materials, woven materials, etc. In addition, some or all of the features from one or more of the above-described embodiments can be combined to form other docking device embodiments.

[0104] It may also be desirable to have some portions of the coils have low friction, while other areas have higher friction. The lower friction surfaces or covers 1170 on the upper and lower coils may help with deployment and provide smoother insertion of the docking device 1100, and the higher friction surface in the center area may help hold the docking device in place. Thus, as Figure 15As seen in the docking device 1100, an additional braided layer 1180 can be added to the central region 1110 of the docking device 1100. The braided layer or other high friction layer 1180 provides additional friction to the THV as the THV is expanded in the docking device 1100. The friction formed at the interface between the inner surface of the central region 1110 of the docking device 1100, the native mitral valve leaflets and the outer surface of the THV creates a more secure locking mechanism to more securely anchor the THV and the docking device 1100 to the native annulus. The braided layer can be limited to extending only through the central coil of the docking device 1100, so that the upper region 1130 and the lower region 1120 of the docking device 1100 maintain lower friction. The braid can also provide a larger surface area to promote tissue ingrowth. Although the cover 1180, surface / cover 1170 and other features / characteristics are described with respect to the device 1100, these can be incorporated into the docking devices described elsewhere herein in the same or similar manner.

[0105] Furthermore, embodiments of docking devices have been generally discussed above, and examples have been given with respect to anchoring a replacement valve at the mitral valve location. However, as also described above, docking devices as described, or slightly modified versions thereof, can be applied in a similar manner to valve replacements (e.g., for treating insufficiency problems) at other valve locations (e.g., at the tricuspid valve or aortic location). The docking device can similarly be made of or include a shape memory material (e.g., nitinol) and / or a non-shape memory material. While the shape of other valve annuli may be rounder or more circular than the mitral valve annulus, patients diagnosed with insufficiency at either location still exhibit an enlarged annulus that both prevents proper attachment of the native leaflets and may cause the annulus to become too large, too soft, or otherwise too unsound to securely hold an expandable valve therein. Therefore, the use of a rigid or semi-rigid docking device may also be advantageous for anchoring a replacement valve at those valve locations.

[0106] When applied to valves other than the mitral valve, the docking device may also provide a more secure landing area at those locations. The docking device and replacement valve may be applied similarly as discussed with respect to implantation at the mitral valve. A possible access point for tricuspid valve replacement may be, for example, a transseptal approach, while a possible access point for aortic replacement may be, for example, a transfemoral approach, but the access to the various valve sites is not limited thereto. The use of coil-shaped docking devices at other valve sites as previously described also serves to circumferentially tighten or clamp the native leaflets between the coils of the docking device after the replacement valve is deployed at the native annulus, which further prevents or reduces sliding or other movement of the docking device and sliding or other movement of the interposed tissue relative to the docking device, and prevents undesirable growth or expansion of the native annulus over time.

[0107] The docking devices described herein can also be used alone to treat native valve insufficiency. For example, the coils described herein can be the final implant for treating tricuspid valve insufficiency. The device can be delivered behind the leaflets and chordae tendineae in the right ventricle and reduce the diameter of the orifice. Since the native tricuspid valve leaflets are attached to the annulus on one side and the chordae tendineae on the ventricular side, the orifice is reduced. As previously described, part of the device is located in the right atrium to help anchor or hold the device in place. The portion located in the right ventricle is sized so as to reduce the annulus to the desired diameter.

[0108] For the purposes of this specification, certain aspects, advantages, and novel features of the embodiments of the present disclosure are described herein. The disclosed methods, devices, and systems should not be construed as limiting in any way. Rather, the present disclosure relates to all novel and non-obvious features and aspects of each disclosed embodiment, alone and in various combinations and sub-combinations with one another. The methods, devices, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed embodiments require the presence of any one or more specific advantages or problems to be solved. Even if not described together above, the features and characteristics of one embodiment may be combined with the features and characteristics of another embodiment.

[0109] Although some of the operations in the disclosed embodiments are described in a particular sequential order for ease of introduction, it should be understood that this manner of description includes rearrangement unless the specific language set forth below requires a particular ordering. For example, the operations described in sequence 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 method can be used in conjunction with other methods, and the various steps may be combined in various ways even if not described together above. In addition, the description sometimes uses terms like "provide" or "implement" to describe the disclosed method. These terms are high-level abstractions of the actual operations that are performed. The actual operations corresponding to these terms may vary depending on the specific implementation and are easily recognized by those of ordinary skill in the art.

[0110] In view of the many possible embodiments to which the principles of the present disclosure may be applied, it should be recognized that the illustrated embodiments are merely preferred examples and should not be taken as limiting the scope of the disclosure, which is instead defined by the appended claims.

Claims

1. A docking device for docking an artificial heart valve to a native heart valve, the docking device comprising: a first coil comprising a proximal end, a distal end, and a plurality of turns extending between the proximal end and the distal end, wherein the plurality of turns defines an interior space; a second coil comprising at least one turn; and wherein a portion of the first coil contacts a portion of the second coil, and The second coil extends around the outside of the first coil and extends radially outward to be wider than the first coil. 2 . The docking device according to claim 1 , wherein the first coil and the second coil are formed integrally with each other. 3 . The docking device according to claim 1 , wherein the first coil and the second coil are formed as separate coils connected to each other.

4. The docking device according to any one of claims 1 to 3, wherein the second coil is connected to the first coil near the proximal end of the first coil, wherein the second coil extends away from the first coil and toward the distal end of the first coil.

5. The docking device according to any one of claims 1 to 3, wherein the second coil is connected to the first coil near the distal end of the first coil, wherein the second coil extends side by side in contact with the first coil in a distal region of the docking device, and further wherein the second coil is split apart from the first coil toward the proximal end of the first coil.

6. The docking device of any one of claims 1-3, wherein the first coil and the second coil each have a substantially rectangular cross-sectional shape.

7. The docking device of any one of claims 1-3, wherein the first coil and the second coil each have a substantially circular cross-sectional shape.

8. The docking device according to any one of claims 1 to 3, wherein the at least one turn of the second coil is between a half turn and five full turns.

9. The docking device of any one of claims 1-3, further comprising a high friction cover on a portion of the first coil, the high friction cover being configured such that sliding of the docking device relative to the native leaflet is inhibited when implanted.

10. The docking device of any one of claims 1-3, further comprising a covering having a substantial surface area to promote tissue ingrowth.

11. A system for replacing a heart valve, the system comprising: valve replacement; and A docking device, wherein the docking device comprises: a first coil comprising a proximal end, a distal end, and a plurality of turns extending between the proximal end and the distal end, wherein the plurality of turns defines an interior space; a second coil comprising at least one turn; and wherein a portion of the first coil contacts a portion of the second coil; wherein the replacement valve comprises an expandable frame and a plurality of leaflets and is configured to be inserted into the interior space and expanded, the expandable frame defining an expanded outer diameter when in the expanded configuration; wherein the replacement valve in the expanded configuration is configured to apply an outward pressure to the docking device, the outward pressure being sufficient to maintain a stable position of the replacement valve within the interior space; and The second coil extends around the outside of the first coil and extends radially outward to be wider than the first coil.

12. The system of claim 11, wherein the first coil and the second coil are integrally formed with each other.

13. The system of claim 11, wherein the first coil and the second coil are formed as separate coils connected to each other.

14. The system of any one of claims 11-13, wherein the second coil is connected to the first coil near the proximal end of the first coil, wherein the second coil extends away from the first coil and toward the distal end of the first coil.

15. The system of any one of claims 11-13, wherein the second coil is connected to the first coil near the distal end of the first coil, wherein the second coil extends side by side in contact with the first coil in a distal region of the docking device, and further wherein the second coil is split apart from the first coil toward the proximal end of the first coil.

16. The system of any one of claims 11-13, wherein the first coil and the second coil each have a substantially rectangular cross-sectional shape.

17. The system of any one of claims 11-13, wherein the first coil and the second coil each have a substantially circular cross-sectional shape.

18. The system of any one of claims 11-13, wherein the at least one turn of the second coil is between a half turn and 5 full turns.

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