Docking station for transcatheter valves - Patent application

Abstract

To provide transcatheter implantable device frames, and docking stations or docking devices for transcatheter implantable devices.SOLUTION: Docking stations for transcatheter valves are described. The docking stations can include an expandable frame, at least one sealing portion, and a valve seat. The expandable frame can be configured to conform to an interior shape of a portion of the circulatory system when expanded inside the circulatory system. The sealing portion can be configured to contact an interior surface of the circulatory system to create a seal. The valve seat can be connected to the expandable frame and can be configured to support an expandable transcatheter valve. The docking stations are adaptable to different anatomies / locations to allow implantation of a transcatheter valve in a variety of anatomies / locations.SELECTED DRAWING: Figure 6

Description

[Technical field]

[0001] cross reference This application claims priority to U.S. Provisional Patent Application No. 62 / 527,577, filed June 30, 2017, U.S. Provisional Patent Application No. 62 / 529,996, filed July 7, 2017, and U.S. Provisional Patent Application No. 62 / 529,902, filed July 7, 2017, the entire disclosures of which are incorporated herein by reference in their entireties. [Background technology]

[0002] Prosthetic heart valves can be used to treat valvular heart disease. The natural heart valves (aortic, pulmonary, tricuspid, and mitral) function to prevent reverse or regurgitation while allowing forward flow. These heart valves can be rendered ineffective by congenital, inflammatory, infectious, and other diseases. Such diseases can ultimately lead to serious cardiovascular damage or death. For many years, physicians have attempted to treat such diseases by surgical repair or replacement of the valves during open-heart surgery.

[0003] A transcatheter technique for introducing and implanting a prosthetic heart valve using a catheter in a less invasive manner than open-heart surgery can reduce the complications associated with open-heart surgery. In this technique, the prosthetic valve can be crimped onto the end portion of a catheter and advanced through the patient's blood vessels until the valve reaches the implantation site. The valve at the catheter tip can then be expanded to its functional size at the site of the defective natural valve, such as by inflating a balloon on which the valve is mounted, or, for example, the valve can have a resilient self-expanding stent or frame that expands the valve to its functional size when it is advanced from a delivery sheath at the distal end of the catheter. Optionally, the valve can have a balloon-expandable frame, a self-expanding frame, a mechanically expandable frame, and / or a frame that is expandable in multiple or combination of ways.

[0004] A transcatheter heart valve (THV) may be appropriately sized to be placed inside many native aortic valves. However, in the case of larger native valves, vessels (e.g., enlarged aorta), grafts, etc., the transcatheter aortic valve may be too small to be secured into a larger implantation or placement site. In this case, the transcatheter valve may not be large enough to properly expand inside the native valve or other implantation or placement site, or the implantation / placement site may not provide a good seat for the THV to be secured in place. As one example, aortic regurgitation may be associated with difficulty in securely implanting the THV into the aorta and / or aortic valve. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] U.S. Patent Application Serial No. 15 / 422,354 [Patent Document 2] US Patent Application Publication No. 2017 / 0231756 [Patent Document 3] U.S. Provisional Patent Application No. 62 / 292,142 [Patent Document 4] U.S. Patent No. 8,002,825 [Patent Document 5] International Publication No. 2000 / 42950 [Patent Document 6] U.S. Patent No. 5,928,281 [Patent Document 7] U.S. Patent No. 6,558,418 [Patent Document 8] U.S. Patent No. 6,540,782 [Patent Document 9] U.S. Pat. No. 3,365,728 [Patent Document 10] U.S. Pat. No. 3,824,629 [Patent Document 11] U.S. Pat. No. 5,814,099 [Patent Document 12] International Application No. PCT / US2018 / 040337 [Patent Document 13] U.S. Provisional Patent Application No. 62 / 527,577 Summary of the Invention [Means for solving the problem]

[0006] This summary is meant to provide examples and is not intended to limit the scope of the invention in any way. For example, any feature included in the examples of this summary is not required by the claims unless the claims explicitly recite that feature. This description discloses exemplary embodiments of a transcatheter implantable device frame and a docking station or device for a transcatheter implantable device. The transcatheter implantable device frame and the docking station / device can be constructed in a variety of ways. The transcatheter device frame can include devices such as valves. The docking station or device provides a landing zone for a transcatheter device such as a transcatheter valve.

[0007] A docking station / device for use within the body or the body's circulatory system (e.g., heart, native heart valves, blood vessels, vascular system, arteries, veins, aorta, inferior vena cava (IVC), superior vena cava (SVC), pulmonary artery, aortic valve, pulmonary valve, mitral valve, tricuspid valve, etc.) can include at least one sealing portion, a frame, and a valve seat. The docking station and its frame can be configured or shaped to match the shape of the portion of the body in which it is to be implanted, e.g., to match the shape of the aorta, IVC, SVC, etc. For example, the docking stations and frames herein may be configured to conform to the internal shape of the circulatory system (e.g., blood vessels, aorta, IVC, SVC, pulmonary artery, etc.) when expanded inside the circulatory system such that the expandable frame is capable of expanding in multiple locations (e.g., 2, 3, 4, 5, 6, 7, 8, or more) to conform to multiple bulges in the circulatory system, and / or is capable of contracting (e.g., expanding less, having a smaller diameter, etc.) in multiple locations (e.g., 2, 3, 4, 5, 6, 7, 8, or more) to conform to multiple narrowed regions of the circulatory system. Additionally, regardless of varying or more uniform anatomy, the docking stations and frames herein, when expanded inside the circulatory system, may be configured such that a majority (e.g., greater than 50%), greater than 60%, greater than 70%, greater than 80%, or more of the docking station contacts the interior surface of the circulatory system, distributing pressure and force exerted by the docking station over the portion or length of the docking station in contact with the interior surface. This may be useful, for example, in treating aortic regurgitation caused by an enlargement of the aortic valve and / or aorta.

[0008] The sealing portion of the various docking stations / devices herein may be formed and configured in any of the manners described in this disclosure, for example, the sealing portion may be integrally formed with the frame (including coatings / materials attached to the frame) or may include a combination of integral and attached elements / components. The sealing portion may be configured to contact an interior surface of the circulatory system (e.g., blood vessels, vasculature, aorta, IVC, SVC, heart, native heart valves, aortic valve, pulmonary valve, mitral valve, tricuspid valve, etc.).

[0009] The frames of the various docking stations herein may be made and configured in any of the manners described in this disclosure, for example, the frames may be made from Nitinol, Elgiloy, stainless steel, and combinations thereof. The frames may be inflatable frames, for example, self-inflatable, manually inflatable (e.g., balloon inflatable), mechanically inflatable, or combinations thereof. The frames may be configured to conform to an internal shape of a portion of the circulatory system (e.g., blood vessels, vasculature, heart, native heart valves, etc.) when inflated inside the circulatory system.

[0010] Optionally, the frame can include a plurality of spring segments connected to a plurality of stent segments. The spring elements can include spring wire and can be compression, torsion, or tension springs. The stent segments can be integrally formed with the spring elements or attached to the spring elements.

[0011] Similarly, the valve seats of the various docking stations herein may also be formed and configured in any of the manners described in this disclosure, for example, the valve seats may be integrally formed with the frame, separately attached, or may include a combination of integral and attached elements / components. The valve seats may be connected to an expandable frame. The valve seats may be configured to support a prosthetic valve (e.g., an expandable transcatheter valve, a transcatheter heart valve, a transcatheter aortic valve, an expandable valve, etc.).

[0012] The docking stations / devices described above and elsewhere herein may be used to form a docking assembly or system, for example, including a graft or other elements. For example, a docking assembly / system (e.g., a docking device assembly, a docking station assembly, a docking device system, etc.) may include a graft and a docking station / device. The graft may be shaped to match a portion of the interior shape of a first portion of a vessel (e.g., a vein, an artery, an aorta, etc.). The docking station / device and the graft may be coupled to one another. A portion of the docking station / device may engage an interior of the graft.

[0013] The various docking stations / devices described herein may be used in an assembly, as discussed above, that may include an expandable frame, at least one sealing portion, and a valve seat, each of which may include features of these types of components described elsewhere herein. The expandable frame may be configured to conform to an interior shape of a second portion of a blood vessel when expanded inside the blood vessel. The sealing portion may be configured to contact an interior surface of the circulatory system or blood vessel. The sealing portion may include a coating / material or fabric attached to the frame. The valve seat may be part of the expandable frame and / or may be connected to the expandable frame and may be configured to support a prosthetic valve (e.g., an expandable transcatheter valve, a transcatheter heart valve, an aortic valve, an expandable valve, etc.).

[0014] The docking assembly / system may optionally be formed integrally with the valve, for example, such that the combination of the docking station / device and valve is a prosthetic valve or a transcatheter prosthetic valve that can be implanted in the same step.

[0015] In one embodiment, the docking station includes an expandable frame configured to conform to an internal shape of the vessel (and / or other parts of the circulatory system) when expanded inside the vessel. The docking station can include at least one sealing portion configured to contact an interior surface of the vessel. The docking station includes a valve seat configured to support a prosthetic valve or an expandable transcatheter valve. The valve seat can be positioned radially inward (e.g., radially overlapping) an outer wall of the frame or axially spaced from the outer wall such that there is no radial overlap. The valve seat can be coaxial with the outer wall of the frame.

[0016] The valve seat may include a first portion of the expandable frame (which may be annular), and the link may connect the first portion of the expandable frame to a second portion of the expandable frame, the second portion including an outer wall (which may be annular). The link may be curved, e.g., curved in a semicircular shape, an undulating shape, etc. The entire frame and / or the outer wall of the frame may include a plurality of struts. The thickness of the link may be the same as or less than the thickness of the struts. The link and struts may be integrally formed, and a transition portion may transition from the thickness of the link to the thickness of the strut.

[0017] The apex of the link may be bent such that portions of the link on either side of the apex extend away from one another at an acute angle. The apex of the link may include an upwardly extending circular portion and / or a downwardly extending circular portion. The link may extend at an angle relative to the radial direction from the first portion to the second portion of the inflatable frame. The link may be twisted as it extends from the valve seat to the annular wall.

[0018] The tubular graft may be coupled to an expandable frame, and the graft may be configured to extend axially beyond the end of the expandable frame. The frame may include a plurality of stent segments connected to a plurality of spring elements. The spring elements may be comprised of spring wires, compression springs, torsion springs, tension springs, and combinations thereof. The struts of the expandable frame may be integrally formed with the spring elements. The sealing portion and / or the valve seat may be integrally formed with the frame. The expandable frame may include no legs, only one leg, or multiple legs, the legs extending proximally beyond the remainder of the frame. The frame may include an elongated second leg, the elongated second leg extending further proximally than the end of the first leg.

[0019] In one embodiment, the inflatable docking station frame includes an annular valve seat having an end, an annular outer wall including struts disposed around the valve seat, and links connecting the ends of the annular valve seat to the annular outer wall. The thickness of the links can be the same as or less than the thickness of the struts. The links and struts can be integrally formed and can have a transition, transitioning from the thickness of the links to the thickness of the struts. The links are curved, for example curved in a semicircular shape. The apex of the link can be bent such that portions of the link on either side of the apex extend away from each other at an acute angle. The apex of the link can include an upwardly extending circular portion and / or a downwardly extending circular portion. The links can extend from a first portion to a second portion of the inflatable frame at an angle relative to the radial direction. The links can be twisted as they extend from the valve seat to the annular wall. The inflatable frame can include zero, only one, or multiple legs that extend proximally beyond the remainder of the frame. The frame can include an elongated second leg that extends further proximally than the end of the first leg.

[0020] In one embodiment, the inflatable docking station frame includes an annular valve seat having an end, an annular outer wall including struts disposed about the valve seat, and links connecting the ends of the annular valve seat to the annular outer wall. The links may be twisted and / or angled as they extend between the annular outer wall and the annular valve seat. The thickness of the links may be the same as or less than the thickness of the struts. The frame and its components (e.g., struts, links, etc.) may have the same or similar features as discussed above and elsewhere herein.

[0021] In one embodiment, the expandable docking station frame includes an annular valve seat having an end, an annular outer wall including struts disposed around the valve seat, and links connecting the ends of the annular valve seat to the annular outer wall, the links extending from the valve seat to the annular wall at an angle relative to the radial direction. The links may be twisted and / or angled as they extend between the annular outer wall and the annular valve seat. The thickness of the links may be the same as or less than the thickness of the struts. The frame and its components (e.g., struts, links, etc.) may have the same or similar features as discussed above and elsewhere herein.

[0022] In one embodiment, the docking station assembly includes a graft configured to conform to an internal shape of a first portion of a blood vessel when expanded inside the blood vessel, and a docking station coupled to the graft. The docking station can include an expandable frame configured to conform to an internal shape of a second portion of the blood vessel when expanded inside the blood vessel. The docking station can include at least one sealing portion configured to contact an interior surface of the blood vessel when expanded inside the blood vessel. The docking station can include a valve seat, the valve seat configured to support an expandable transcatheter valve. The graft, frame, sealing portion, and valve seat can have the same or similar features as discussed above and elsewhere herein.

[0023] In one embodiment, the docking station includes a frame configured to transition from a first configuration to a second configuration, where at least a first portion of the frame is curled when in the second configuration, and the frame is configured such that the frame curls back on itself when the frame transitions from the first configuration to the second configuration. The docking station is configured to capture a natural leaflet of the native valve when the frame curls back on itself. The docking station can be configured such that the natural leaflet can be clamped between the valve seat and another portion of the docking station. In one embodiment, the first portion of the frame can be curled at least 360 degrees when in the second configuration. The second end can overlap at least a portion of the first end when in the second configuration. The first configuration of the frame can be a straightened configuration or a configuration in which no portion of the frame is curled. The frame can be configured to be held in the straightened configuration inside the delivery catheter and can be prevented from transitioning to the second configuration until exiting the catheter.

[0024] The docking station can also include a valve seat configured to support an inflatable transcatheter valve. The valve seat can be formed by inner struts extending from a first end of the frame to a junction. The inner struts can form a diamond shaped opening. The apex and outer struts can extend from the junction to a second end and form a continuous opening. The docking station can also include at least one sealing portion configured to contact an interior surface of the anatomical structure.

[0025] The frame may include one or more legs extending to an end of the frame. The one or more legs may extend from an inner strut of the valve seat. The one or more legs may include an elongated leg that extends axially further than a shorter leg of the one or more legs.

[0026] In one embodiment, the docking station includes a frame, the frame including a retaining portion surrounding an inflow area and a valve seat configured to support an expandable transcatheter valve, the retaining portion having a first diameter greater than a second diameter of the valve seat, and the tapered region transitioning between the first diameter and the second diameter. The docking station can include at least one sealing portion configured to contact an interior surface of the circulatory system. The tapered region can be configured to transition in a direction from the inflow area to the outflow area between the first diameter of the retaining portion and the second diameter of the valve seat. The frame can include a plurality of metal struts forming cells.

[0027] The docking station can include a band that extends around the valve seat and causes the valve seat to be non-expandable or substantially non-expandable. The valve seat can be configured such that it does not radially overlap any of the retaining portions. The valve seat can be positioned generally on one axial side of the retaining portion.

[0028] The docking station may further include an atraumatic outer segment extending radially outward from the valve seat. The outer segment may be round and / or toroidal. The outer segment may include a plurality of struts forming cells and / or may include a foam material. The docking station may include a first sealing portion configured to inhibit blood flow between an atrial-venous junction in the body and the docking station when implanted, and the docking station may include a second sealing portion configured to inhibit blood flow between the valve seat and a transcatheter valve implanted in the valve seat.

[0029] The frame may be configured to conform to the internal shape of the vessel when expanded inside the vessel such that the frame expands to conform to bulges and narrowing areas of the vessel in multiple locations and distributes pressure from the docking station to the vessel over most of the length of the docking station. This may be useful, for example, in treating aortic regurgitation caused by aortic valve and / or aorta enlargement, where it is desired to avoid excessive outward pressure on the aortic valve and / or aorta. The docking station may include an axially extending leg portion at an end of the retaining portion, and the docking station may further include an elongated leg portion, the elongated leg portion extending axially further from the remainder of the retaining portion than the leg portion.

[0030] The system may include a first docking station having a first valve seat, a second docking station having a second valve seat, each of the first valve seat and the second valve seat configured to support an inflatable valve (e.g., an inflatable transcatheter valve), and a connecting portion connecting the first docking station and the second docking station together to form a dual docking station. The system may include at least one sealing portion or a plurality of sealing portions configured to contact one or more interior surfaces of the circulatory system. The connecting portion may be configured to allow blood to flow freely through the connecting portion when the system is implanted in the body. The connecting portion may be integrally formed with the first docking station and the second docking station.

[0031] The dual docking station may be configured such that a first docking station may be implanted in the inferior vena cava of a body and a second docking station may be placed in the superior vena cava of a body, with the first valve inflated in a first valve seat and the second valve inflated in a second valve seat. The dual docking station may be configured such that a first docking station may be implanted in the inferior vena cava of a body and a second docking station may be placed in the superior vena cava of a body, with only one of the first docking station and the second docking station having an inflatable valve received therein.

[0032] The system can include a first valve, the first valve being expandable within the first valve seat such that the first valve is securely held within the first valve seat, and the system can include a second valve, the second valve being expandable within the second valve seat such that the second valve is securely held within the second valve seat.

[0033] The system and / or the dual docking station may be configured to be adjustable in overall length inside the circulatory system at the implantation site, for example, such that the dual docking station may be sized to fit different anatomies (e.g., varying distances between the IVC and SVC of different patients) during delivery, and other features and components of the dual docking station described elsewhere herein may be incorporated.

[0034] The docking placement system / assembly (e.g., docking station placement system, docking device placement system, etc.) can include a catheter, the catheter defining a delivery passageway and having a distal opening. The placement system can also include a self-expandable docking station, which can be radially compressed and expanded, for example, between a first configuration and a second configuration, or between a compressed configuration and an expanded configuration. The docking station can be configured to be retained in a compressed configuration inside the delivery passageway of the catheter, for example, until delivery at the implantation site. The placement system includes a retention device releasably connectable to the docking station. The retention device can be configured to inhibit the docking station from ejecting distally from the catheter. The retention device can be configured to inhibit the docking station from moving axially relative to the retention device and / or the proximal handle of the system. The retention device can be configured to maintain an axial position of the docking station until the docking station is fully expanded at the implantation site. In one embodiment, the retention device is a pusher having a distal end connectable to a proximal end of the docking station. Other docking placement system / assembly features and components described herein may be included as well.

[0035] The docking station can include at least one leg, the at least one leg extending proximally at a proximal end of the docking station and releasably connectable to the retention device. The docking station can include multiple legs, the multiple legs extending proximally at the proximal end of the docking station, the multiple legs can be uniformly spaced radially around the proximal end of the docking station. The docking station can include only one leg, the one leg extending proximally at the proximal end of the docking station and releasably connectable to the retention device, such that the docking station can be fully inflated while the one leg is connected to the retention device and then releasable.

[0036] The docking station can include a first leg and a second leg, each extending proximally at a proximal end of the docking station and releasably connectable to the retention device, the first leg being longer than the second leg. The retention device, the first leg, and the second leg can be configured such that during delivery, the retention device first releases the second leg, allowing the docking station to fully expand while the first leg is still connected to the retention device.

[0037] The retention device may include a lock and release connector having a body and a door, the door being movable from a first position to a second position. The lock and release connector may have a second door movable from a third position to a fourth position, the lock and release connector configured to hold the first leg of the docking station between the door and the body in the first position and to hold the second leg of the docking station between the second door and the body in the third position. The retention device may include a lock and release connector having a body and a door, the door being movable from the first position to a second position, the retention device connected to the docking station when the leg is between the door and the body and when the door is in the first position. The retention device may be configured to release the leg when the door is moved to the second position.

[0038] The retention device can include a retaining line that can be used to maintain the position of the docking station when the docking station is deployed from the catheter and fully radially expanded.

[0039] The retention device can include a pin (or narrowed portion of the pusher, inner shaft, etc.) that extends inside at least the proximal end of the docking station and inhibits the docking station from popping out of the distal end of the catheter. The pin can be configured to inhibit the docking station from popping out of the distal end of the catheter by inhibiting the proximal end of the docking station from angling out of parallel (e.g., relative to the inner surface of the catheter and / or the outer surface of the pin / pusher / shaft).

[0040] Various features as described elsewhere in this disclosure may be included in the examples summarized here, and various methods and steps for using the examples and features may be used, including as described elsewhere herein.

[0041] A further understanding of the nature and advantages of the disclosed invention may be obtained from the following description and claims, particularly when considered in conjunction with the accompanying drawings, in which like parts bear like reference numerals.

[0042] A further understanding of the nature and advantages of the disclosed invention may be obtained from the following description and claims, particularly when considered in conjunction with the accompanying drawings, in which like parts bear like reference numerals.

[0043] To further clarify various aspects of the embodiments of the present disclosure, a more particular description of certain embodiments will be made with reference to various aspects of the accompanying drawings. These drawings depict merely exemplary embodiments of the present disclosure and therefore should not be considered as limiting the scope of the present disclosure. Moreover, while the figures may be drawn to scale for some embodiments, the figures are not necessarily drawn to scale for all embodiments. The embodiments of the present disclosure will be described and explained with additional particularity and detail through the use of the accompanying drawings. [Brief description of the drawings]

[0044] [Figure 1A] FIG. 1 is a cutaway view of a human heart in a diastolic phase. [Figure 1B] FIG. 1 is a cutaway view of a human heart in systole. [Diagram 2] FIG. 2 is a cutaway view of a human heart with an exemplary embodiment of an exemplary docking station positioned within a blood vessel (the inferior vena cava IVC). [Figure 2A]For example, an exemplary docking station and an end view of a valve showing the valve in an open configuration so that blood can flow through the valve when the heart is in a diastolic phase. [Figure 2B] For example, a docking station and an end view of a valve showing the valve in a closed configuration when the heart is in a systolic phase, as shown in FIG. 2. [Figure 3A] A cross-sectional view of an exemplary embodiment of a docking station with an exemplary transcatheter valve disposed inside the docking station. [Figure 3B] A top view of the docking station and valve illustrated by FIG. 3A. [Figure 3C] A perspective view of an exemplary embodiment of a docking station illustrating an example of a frame portion that can be used in the docking station of FIGS. 3A-3B. [Figure 3D] A cross-sectional view of the docking station illustrated by FIG. 3A, where the transcatheter valve shown is a representative valve tip type transcatheter valve. [Figure 4A] A diagram schematically illustrating the placement of the docking station. [Figure 4B] A diagram schematically illustrating the placement of the docking station. [Figure 4C] A diagram schematically illustrating the placement of a valve within the docking station. [Figure 4D] A diagram schematically illustrating the placement of a valve within the docking station. [Figure 4E] A diagram schematically illustrating the conformity of the docking station to an inner surface having varying sizes. [Figure 5A] A cross-sectional view of an exemplary embodiment of a docking station with an exemplary transcatheter valve disposed inside the docking station. [Figure 5B] A top view of the docking station and valve illustrated by FIG. 5A. [Figure 5C] FIG. 5B is a bottom view of the docking station and valve illustrated by FIG. 5A. [Figure 6] FIG. 2 is a perspective view of an exemplary embodiment of a docking station. [Figure 7A] 1 is a cross-sectional view of an exemplary embodiment of a docking station with an exemplary transcatheter valve disposed inside the docking station. [Figure 7B] FIG. 7B is a top view of the docking station and valve illustrated by FIG. 7A. [Figure 8A] 1 is a cross-sectional view of an exemplary embodiment of a docking station with an exemplary transcatheter valve disposed inside the docking station. [Figure 8B] FIG. 8B is a top view of the docking station and valve illustrated by FIG. 8A. [Figure 9A] 1 is a cross-sectional view of an exemplary embodiment of a docking station with an exemplary transcatheter valve disposed inside the docking station. [Figure 9B] FIG. 9B is a top view of the docking station and valve illustrated by FIG. 9A. [Figure 10] FIG. 2 is a perspective view of an exemplary embodiment of a docking station. [Figure 11] 11 is a graph illustrating the relationship between outward radial force and expanded diameter of the docking station frame. [Figure 12] 1 is a perspective view of an exemplary embodiment of a docking station frame. [Figure 12A] FIG. 13 illustrates an enlarged portion of FIG. 12. [Figure 12B] FIG. 13 illustrates an enlarged portion of FIG. 12. [Figure 13] FIG. 13 is a perspective view of the docking station frame illustrated in FIG. 12. [Figure 14] 1 is a perspective view of an exemplary embodiment of a docking station frame. [Figure 15]1 is a perspective view of a portion of an exemplary embodiment of a docking station frame. [Figure 16] 16 is a perspective view of an exemplary embodiment of a link between an inner portion (e.g., a valve seat) and an outer portion of the docking station frame of FIG. 15. [Figure 17] 1 is a perspective view of a portion of an exemplary embodiment of a docking station frame. [Figure 18] 18 is another perspective view of a portion of the docking station frame of FIG. 17. [Figure 19] 19 is a perspective view of an exemplary embodiment of a link between an inner portion (e.g., a valve seat) and an outer portion of the docking station frame of FIGS. 17 and 18. FIG. [Figure 20A] 13A-13C show exemplary embodiments of link shapes or link portion shapes that may be used between the inner portion / valve seat and the outer portion of the docking device frame. [Figure 20B] 13A-13C show exemplary embodiments of link shapes or link portion shapes that may be used between the inner portion / valve seat and the outer portion of the docking device frame. [Figure 20C] 13A-13C show exemplary embodiments of link shapes or link portion shapes that may be used between the inner portion / valve seat and the outer portion of the docking device frame. [Figure 21A] 1 illustrates an exemplary embodiment of crimping an exemplary docking station frame. [Figure 21B] 1 illustrates an exemplary embodiment of crimping an exemplary docking station frame. [Figure 21C] 1 illustrates an exemplary embodiment of crimping an exemplary docking station frame. [Figure 21D] 1 illustrates an exemplary embodiment of crimping an exemplary docking station frame. [Figure 21E]1 illustrates an exemplary embodiment of crimping an exemplary docking station frame. [Figure 21F] 1 illustrates an exemplary embodiment of crimping an exemplary docking station frame. [Figure 21G] 1 illustrates an exemplary embodiment of crimping an exemplary docking station frame. [Fig. 21H] 1 illustrates an exemplary embodiment of crimping an exemplary docking station frame. [Figure 22A] 1 illustrates an exemplary placement of an exemplary docking station. [Figure 22B] 1 illustrates an exemplary placement of an exemplary docking station. [Figure 22C] 1 illustrates an exemplary placement of an exemplary docking station. [Figure 23A] 1 illustrates an exemplary placement of an exemplary docking station. [Figure 23B] 1 illustrates an exemplary placement of an exemplary docking station. [Figure 23C] 1 illustrates an exemplary placement of an exemplary docking station. [Figure 24A] 1 illustrates an exemplary placement of an exemplary docking station. [Figure 24B] 1 illustrates an exemplary placement of an exemplary docking station. [Figure 24C] 1 illustrates an exemplary placement of an exemplary docking station. [Diagram 25] FIG. 2 is a side view of an exemplary docking station frame. [Figure 26] 1 is a perspective view of an exemplary embodiment of a docking station frame. [Figure 27] FIG. 27 is a top view of the docking station frame illustrated in FIG. 26. [Figure 28]FIG. 27 is a side view of the docking station frame illustrated in FIG. 26. [Figure 29] FIG. 1 is a perspective view of an exemplary embodiment of a docking station including an exemplary transcatheter valve therein. [Diagram 30] 30 is a cross-sectional view of an exemplary embodiment of a coating material that may be used with the docking station illustrated in FIG. 29. [Diagram 31] FIG. 30 is a cut-away view of a human heart showing a portion of the right atrium and IVC of the human heart with the docking station illustrated by FIG. 29 positioned in the IVC. [Diagram 32] FIG. 2 is a perspective view of an exemplary embodiment of a docking station. [Diagram 33] FIG. 33 is a cutaway view of a human heart with the docking station illustrated in FIG. 32 positioned in the inferior vena cava. [Diagram 34] FIG. 2 is a side view of a portion of an exemplary embodiment of a docking station. [Diagram 35] FIG. 35 is a perspective view of the docking station shown in FIG. 34. [Diagram 36] 1 is a schematic cutaway view of a portion of a human heart with an exemplary docking station positioned in the inferior vena cava and right atrium. [Figure 37] FIG. 2 is a side view of an exemplary embodiment of a docking station frame or portion. [Figure 38] 38 illustrates bending of the docking station frame / frame portion of FIG. 37. [Figure 39] A figure illustrating the expansion and contraction of a portion of the docking station frame / frame portion illustrated by Figure 37. [Diagram 40] 1 illustrates an exemplary embodiment of a frame portion and a spring / flexible portion of a docking station. [Diagram 41] 1 illustrates an exemplary embodiment of a docking station placed in a blood vessel. [Diagram 42] FIG. 2 is a cutaway view of a human heart with an exemplary embodiment of a docking station extending from the superior vena cava to the inferior vena cava. [Diagram 43] FIG. 1 is a cutaway view of a human heart with an exemplary embodiment of a docking station extending from the superior vena cava to the inferior vena cava. [Diagram 44] FIG. 2 is a cutaway view of a human heart with an exemplary embodiment of a docking station extending from the superior vena cava to the inferior vena cava. [Diagram 45] FIG. 2 is a cutaway view of a human heart with an exemplary embodiment of a docking station extending from the superior vena cava to the inferior vena cava. [Figure 46] FIG. 2 is a cutaway view of a human heart with an exemplary embodiment of a docking station extending from the superior vena cava to the inferior vena cava. [Figure 47] FIG. 47 is a diagram of the docking station of FIG. 46 with the sealing portion deployed. [Figure 48] FIG. 1 illustrates an example embodiment of a profile for a docking station. [Figure 49] FIG. 1 illustrates an example embodiment of a profile for a docking station. [Figure 50] FIG. 50 is a cutaway view of a human heart with the docking station illustrated in FIG. 49 positioned in the inferior vena cava. [Figure 51] FIG. 2 is a side view of an exemplary embodiment of a docking station. [Figure 52] FIG. 52 is a cutaway view of the human heart with the docking station illustrated in FIG. 51 positioned in the inferior vena cava. [Diagram 53] 1 is a schematic diagram of an exemplary embodiment of a docking station. [Figure 54] 1 is a schematic diagram of an exemplary embodiment of a docking station. [Figure 55A] 54 illustrates three different positions of the docking station of FIG. 53. [Figure 55B]54 illustrates three different positions of the docking station of FIG. 53. [Figure 55C] 54 illustrates three different positions of the docking station of FIG. 53. [Figure 56] FIG. 54 is a cutaway view of the human heart with the docking station illustrated in FIG. 53 positioned in the inferior vena cava. [Figure 57] FIG. 2 is a perspective view of an exemplary embodiment of a docking station. [Figure 58] FIG. 58 is a cutaway view of a human heart with the docking station illustrated in FIG. 57 positioned in the inferior vena cava IVC. [Figure 59A] 1 is a perspective view of an exemplary embodiment of a docking station in a partially compressed state. [Figure 59B] FIG. 59C illustrates the docking station of FIG. 59B in an expanded state. [Figure 59C] FIG. 1 illustrates an exemplary embodiment of a docking station. [Fig. 59D] FIG. 59D is a cut-away view of a human heart with the docking station illustrated by FIG. 59C positioned in the inferior vena cava IVC. [Figure 60A] 1 is a cross-sectional view of an exemplary embodiment of a docking station with a transcatheter valve disposed inside the docking station. [Figure 60B] FIG. 60B is a top view of the docking station and transcatheter valve illustrated by FIG. 60A. [Figure 60C] 1 is a cross-sectional view of an exemplary embodiment of a docking station with a transcatheter valve disposed inside the docking station. [Figure 60D] FIG. 60D is a top view of the docking station and transcatheter valve of FIG. 60C. [Figure 60E] 1 is a cross-sectional view of an exemplary embodiment of a docking station with a transcatheter valve disposed inside the docking station. [Figure 60F] FIG. 60F is a top view of the docking station and transcatheter valve of FIG. 60E. [Figure 60G] 1 is a cross-sectional view of an exemplary embodiment of a docking station with a transcatheter valve disposed inside the docking station. [Figure 60H] FIG. 60H is a top view of the docking station and transcatheter valve of FIG. [Fig.60I] 1 is a cross-sectional view of an exemplary embodiment of a docking station with a transcatheter valve disposed inside the docking station. [Fig.60J] FIG. 60I is a top view of the docking station and transcatheter valve of FIG. [Figure 61] FIG. 1 illustrates some non-limiting examples of the types of valves that may be placed in a docking station, for example, in any one of the docking stations herein. [Figure 62] FIG. 1 illustrates some non-limiting examples of the types of valves that may be placed in a docking station, for example, in any one of the docking stations herein. [Figure 63] FIG. 1 illustrates some non-limiting examples of the types of valves that may be placed in a docking station, for example, in any one of the docking stations herein. [Figure 64] FIG. 1 illustrates some non-limiting examples of the types of valves that may be placed in a docking station, for example, in any one of the docking stations herein. [Figure 65A] FIG. 1 illustrates some non-limiting examples of the types of valves that may be placed in a docking station, for example, in any one of the docking stations herein. [Figure 65B]FIG. 1 illustrates some non-limiting examples of the types of valves that may be placed in a docking station, for example, in any one of the docking stations herein. [Figure 65C] FIG. 1 illustrates some non-limiting examples of the types of valves that may be placed in a docking station, for example, in any one of the docking stations herein. [Figure 66A] 11A-11C are diagrams illustrating the radial outward expansion of the docking station as it is deployed; [Figure 66B] 11A-11C are diagrams illustrating the radial outward expansion of the docking station as it is deployed; [Figure 67] 1 is a perspective view of an exemplary distal end of an exemplary pusher or retention device. FIG. [Figure 68A] 1 is a perspective view of an exemplary embodiment of a docking station frame having elongated legs. [Figure 68B] 1 is a side view of an exemplary embodiment of a docking station frame having elongated legs. [Figure 68C] 1 is a perspective view of an exemplary embodiment of a docking station frame having elongated legs. [Figure 69A] 68A, 68B, or 68C. FIG. 68B is a side view of an exemplary embodiment of an extension of a frame, for example, of the frame of FIG. 68A, 68B, or 68C. [Figure 69B] 68A, 68B, or 68C. FIG. 68B is a side view of an exemplary embodiment of an extension of a frame, for example, of the frame of FIG. 68A, 68B, or 68C. [Figure 70] 1 is a perspective view of an exemplary distal end of an exemplary pusher or retention device. FIG. [Figure 71A] 1 illustrates an exemplary placement of an exemplary docking station. [Figure 71B] 1 illustrates an exemplary placement of an exemplary docking station. [Figure 71C] 1 illustrates an exemplary placement of an exemplary docking station. [Figure 72A] 1 illustrates an exemplary placement of an exemplary docking station. [Fig. 72B] 1 illustrates an exemplary placement of an exemplary docking station. [Fig. 72C] 1 illustrates an exemplary placement of an exemplary docking station. [Figure 73A] 1 is a perspective view of an exemplary cover for a docking station frame. [Figure 73B] 1 is a cross-sectional view of an exemplary cover for a docking station frame. [Fig. 74A] 1 illustrates an exemplary installation of an exemplary cover on a docking station. [Fig. 74B] 1 illustrates an exemplary installation of an exemplary cover on a docking station. [Fig. 75A] FIG. 2 is a perspective view of an exemplary cover disposed over a frame. [Fig. 75B] 1 is a cross-sectional view of an exemplary cover disposed over a docking station frame. [Figure 76] FIG. 1 illustrates an exemplary docking station placed within the circulatory system. [Figure 77] 1 is a cut-away view of a human heart with an exemplary embodiment of a docking station positioned within the aorta of the human heart. [Figure 78] 1 is a cut-away view of a human heart with an exemplary embodiment of a docking station and reinforcement device positioned within the aorta of the human heart. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0045] The following description refers to the accompanying drawings, which illustrate certain embodiments of the present invention. Other embodiments having different structures and operations do not depart from the scope of the present invention. Exemplary embodiments of the present disclosure relate to devices and methods for providing a docking station / device or landing zone for a prosthetic valve (e.g., a transcatheter valve, e.g., a transcatheter heart valve, etc.), e.g., valve 29. In some exemplary embodiments, the docking station / device for the prosthetic valve or THV is illustrated as being used in the superior vena cava (SVC), the inferior vena cava (IVC), or both the SVC and the IVC, but the docking station / device (e.g., docking station / device 10, other docking stations / devices herein, modified versions of docking stations, etc.) may be used in other areas of the anatomy, heart, or vasculature, such as the tricuspid valve, the pulmonary valve, the pulmonary artery, the aortic valve, the aorta, the mitral valve, or elsewhere. The docking stations / devices described herein may be configured to accommodate a placed transcatheter valve or THV that is smaller and / or has a different geometry than the space (e.g., anatomy / heart / vasculature / etc.) it will be placed in. For example, the natural anatomy (e.g., IVC) may be elliptical, egg-shaped, or another shape, while the prosthetic valve or THV may be cylindrical.

[0046] Various embodiments of docking stations / devices and examples of prosthetic or transcatheter valves are disclosed herein, and any combination of these options may be made unless specifically excluded. For example, any of the disclosed docking stations / devices may be used with any type of valve and / or any delivery system, even if a particular combination is not explicitly described. Similarly, different constructions and features of docking stations / devices and valves may be mixed and matched, such as by combining any docking station type / feature, valve type / feature, tissue cover, etc., even if not explicitly disclosed. In short, individual components of the disclosed systems may be combined unless mutually exclusive or physically impossible.

[0047] For uniformity, in these and other figures of the present application, the docking stations are typically shown with the right atrial end at the top, while the ventricular or IVC end at the bottom, unless otherwise indicated.

[0048] 1A and 1B are cutaway views of a human heart H in diastolic and systolic phases, respectively. The right ventricle RV and left ventricle LV are separated from the right atrium RA and left atrium LA by the tricuspid valve TV and mitral valve MV (i.e., atrioventricular valves), respectively. Additionally, the aortic valve AV separates the left ventricle LV from the ascending aorta (not identified), and the pulmonary valve PV separates the right ventricle from the pulmonary artery PA. Each of these valves has flexible leaflets that extend inward across their respective orifices, which come together or "coapt" in the flow stream to form a one-way fluid occlusion surface. The docking station and valves of the present application are described primarily with respect to the inferior vena cava IVC, superior vena cava SVC, and aortic / aortic valves for illustrative purposes. For example, a defective aortic valve may be a stenotic aortic valve and / or may suffer from insufficient function and / or regurgitation. Blood vessels, such as the aorta, IVC, SVC, pulmonary artery, etc., may be healthy or may be dilated, distorted, enlarged, have aneurysms, or otherwise underperform. The anatomical structures of the right atrium RA, right ventricle RV, left atrium LA, and left ventricle LV will be described in more detail. The devices described herein may be used in a variety of areas, whether or not explicitly described herein, for example, in the IVC and / or SVC, in the aorta (e.g., an enlarged aorta) as a treatment for a defective aortic valve, in other areas of the heart or vascular system, in grafts, etc.

[0049] The right atrium RA receives deoxygenated blood from the venous system through the superior vena cava SVC and the inferior vena cava IVC, which enter the right atrium from above, and the inferior vena cava IVC, which enters the right atrium from below. The coronary sinus CS is a collection of veins joined together to form a large vessel that collects deoxygenated blood from the heart muscle (myocardium) and delivers it to the right atrium RA. During the diastolic phase or diastole (seen in FIG. 1A), the deoxygenated blood from the IVC, SVC, and CS collected in the right atrium RA passes through the tricuspid valve TV into the RV as the right ventricle RV expands. During the systolic phase or systole (seen in FIG. 1B), the right ventricle RV contracts, pushing the deoxygenated blood collected in the RV through the pulmonary valve PV and the pulmonary artery into the lungs.

[0050] The device described by the present application may be used to supplement the function of a defective tricuspid valve and / or to prevent too much pressure from building up in the RA. During cardiac systole, the leaflets of a normally functioning tricuspid valve TV are closed to prevent venous blood from flowing back into the right atrium RA. When the tricuspid valve does not operate normally, blood may flow retrogradely or back into the right atrium RA, the inferior vena cava IVC, the superior vena cava SVC, and / or other blood vessels during the systole phase. Blood flowing backward into the right atrium increases the volume of blood in the atrium and blood vessels that direct blood to the heart. This may cause the right atrium to enlarge and may cause blood pressure to increase in the right atrium and blood vessels, which may cause damage and / or swelling to the liver, kidneys, legs, other organs, etc. A transcatheter valve or THV implanted in the inferior vena cava IVC and / or superior vena cava SVC can prevent or inhibit blood from flowing retrograde into the inferior vena cava IVC and / or superior vena cava SVC during systole.

[0051] The length L, diameter D, and curvature or contour may vary greatly between the superior vena cava SVC and inferior vena cava IVC of different patients. Also, the relative orientation and location of the IVC and / or SVC may vary between patients. Furthermore, the size or diameter D may vary significantly along the length L of an individual IVC and / or SVC. Also, the anatomy of the IVC and / or SVC is soft, flexible, and dynamic compared to other cardiac vessels such as the aorta. This softer, more flexible, and / or more dynamic (moving and / or shape-changing) nature of the IVC and SVC makes it more difficult for a transcatheter valve frame or a docking station supporting a transcatheter valve to be anchored in the IVC and / or SVC than in the aorta. Furthermore, other regions or other vasculature in other areas of the body and across the patient in which the docking station may be used may also vary significantly in shape and size.

[0052] The left atrium LA receives oxygenated blood from the left and right pulmonary veins, which then proceeds through the mitral valve to the left ventricle. During the diastole phase or diastole (as seen in FIG. 1A), the oxygen-rich blood that collects in the left atrium LA passes through the mitral valve MV to the left ventricle LV and into the left ventricle LV as the left ventricle LV expands. During the diastole phase or systole (as seen in FIG. 1B), the left ventricle LV contracts and pushes the oxygen-rich blood through the aortic valve AV and the aorta through the circulatory system into the body. In one exemplary embodiment, the device described by the present application is used to supplement or replace the function of a defective aortic valve. For example, the device herein is particularly effective for treating aortic regurgitation. During diastole, the leaflets of the normally functioning aortic valve AV are closed to prevent oxygen-rich blood from flowing back into the left ventricle LV. When the aortic valve does not function normally, blood flows retrogradely or back into the left ventricle LV. A THV implanted in the aortic valve helps prevent or inhibit blood from flowing retrogradely into the left ventricle LV during the diastolic phase. The length L, diameter D, and curvature or contour of the aortic root can vary greatly between different patients, especially when the aorta is dilated, distorted, or enlarged. Furthermore, the size or diameter D can vary significantly along the length L of an individual aorta.

[0053] 2, 3A, 3B, and 3C, in one exemplary embodiment, the inflatable docking station / device 10 includes one or more sealing portions 310, a valve seat 18, and one or more retaining portions 314. The sealing portion 310 provides a seal between the docking station 10 and an interior surface 416 (see FIG. 2) of the circulatory system. The valve seat 18 provides a support surface for implanting or retaining the valve 29 in the docking station 10 after the docking station 10 is implanted in the circulatory system. Optionally, the docking station 10 and the valve 29 may be integrally formed, for example, in one embodiment, the valve seat 18 may be omitted. When integrally formed, the docking station 10 and the valve 29 may be placed as a single device, rather than first placing the docking station 10 and then placing the valve 29 in the docking station. Any of the docking stations and / or valve seats 18 described herein may be provided or formed with an integral valve 29.

[0054] The retaining portion 314 helps to keep the docking station 10 and the valve 29 at the implantation or placement site within the circulatory system. The retaining portion 314 can take a wide variety of different forms. In one exemplary embodiment, the retaining portion 314 includes friction enhancing features that reduce or eliminate migration of the docking station 10. The friction enhancing features can take a wide variety of different forms. For example, the friction enhancing features can include barbs, spikes, texturing, adhesives, and / or fabric or polymer coverings with high friction properties on the retaining portion 314. Such friction enhancing features may also be used on any of the various docking stations or retaining portions described herein.

[0055] Additionally, the inflatable docking station 10 and valve 29 as described in various embodiments herein are representative of various docking stations and / or valves described herein or that may be known or developed, for example, a variety of different types of valves may be substituted for and / or used as valve 29 in the various docking stations.

[0056] 2, 2A, and 2B illustrate a representative example of the operation of the docking station 10 and valve 29 disclosed herein. In the examples of FIGS. 2, 2A, and 2B, the docking station 10 and valve 29 are placed in the inferior vena cava IVC. However, the docking station 10 and valve 29 may be placed in any interior surface in a lumen of the heart or body. For example, the various docking stations and valves described herein may be placed in the superior vena cava SVC, tricuspid valve TV, pulmonary valve PV, pulmonary artery, mitral valve MV, aortic valve AV, aorta, or other vasculature / lumen in the body.

[0057] 2 and 2A illustrate the valve 29, docking station 10, and heart H when implanted in the IVC, with the heart H in a diastolic phase. When the heart is in a diastolic phase, the valve 29 is open. Blood flows from the inferior vena cava IVC and superior vena cava SVC into the right atrium RA. Blood flowing from the inferior vena cava IVC flows through the docking station 10 and the valve 29, as shown by arrow 210. Also, during a diastolic phase, blood in the right atrium flows through the tricuspid valve TV into the right ventricle RV and valve, as shown by arrow 212. FIG. 2A illustrates a space 228, which represents that the valve 29 is open when the heart is in a diastolic phase. Various types of valves that can open and close in various ways (e.g., including valves with tissue leaflets that coapt to open and then close) can be used, and thus the figures are meant to be representative of various valves that can operate in different ways. FIG. 2A does not show the interface between the docking station 10 and the inferior vena cava to simplify the drawing. The cross-hatching in FIG. 2A represents blood flow through the valve 29. In an exemplary embodiment, blood is prevented or inhibited from flowing between the inferior vena cava IVC and the docking station 10 by the seal 310, and blood is prevented or inhibited from flowing between the docking station 10 and the valve by implanting or seating the valve in the seat 18 of the docking station 10. In this example, blood can flow substantially or only through the valve 29 when the valve is open (e.g., in one embodiment, only when the heart is in a diastolic phase).

[0058] FIG. 2B illustrates the valve 29 and the docking station 10 when the valve 29 is closed (e.g., when implanted in the IVC and when the heart H is in a systolic phase). The valve 29 is closed when implanted in the IVC and when the heart is in a systolic phase. Blood is prevented from flowing from the right atrium RA into the inferior vena cava IVC by the valve 29 being closed. As such, the closed valve 29 prevents any blood that backs up through the tricuspid valve TV during a systolic phase from being forced into the inferior vena cava IVC. The solid area 252 in FIG. 2B represents the valve 29 being closed (e.g., in one embodiment, when the heart is in a systolic phase). FIG. 2B is meant to be representative of various valves, even though those valves can close in different ways.

[0059] In one exemplary embodiment, the docking station 10 acts as an isolator, which prevents or substantially prevents the radially outward force of the valve 29 from being transmitted to the inner surface 416 of the circulatory system. In one embodiment, the docking station 10 includes a valve seat 18 that resists expansion, e.g., does not expand radially outward (e.g., the diameter of the valve seat does not increase) or does not substantially expand radially outward (e.g., the diameter of the valve seat increases by less than 4 mm) due to the radially outward force of the transcatheter valve or valve 29. The valve seat may simply be configured such that expansion of the THV / valve 29 increases the diameter of the valve seat to a diameter smaller than the outer diameter of the docking station 10 when the docking station is implanted. The retaining portion 314 and the sealing portion 310 may be configured to apply only a relatively small radially outward force (as compared to the radially outward force applied by the valve 29 to the valve seat 18) onto the inner surface 416 of the circulatory system. As with the various docking stations described herein, having a valve seat 18 that is stiffer or less radially expansive than the outer portion of the docking station (e.g., the retaining portion 314 and the sealing portion 310) provides many benefits, including allowing the THV / valve 29 to be implanted into vasculature or tissue of various strengths, sizes, and shapes. The outer portion of the docking station may better conform to the anatomical structure (e.g., vasculature, tissue, heart, etc.) without exerting too much pressure on the anatomical structure, while the THV / valve 29 may be firmly and securely implanted into the valve seat 18 with a force that would prevent or reduce the risk of migration or slipping.

[0060] The docking station 10 can include any combination of one or more different types of valve seats 18, retaining portions 314, and / or sealing portions 310. For example, the valve seats 18 can be separate components attached to the frame 350 of the docking station 10, while the sealing portions are integrally formed with the frame 350 of the docking station. Also, the valve seats 18 can be separate components attached to the frame 350 of the docking station 10, while the sealing portions 310 are also separate components attached to the frame 350 of the docking station. Optionally, the valve seats 18 can be integrally formed with the frame 350 of the docking station 10, while the sealing portions are integrally formed with the frame 350 of the docking station. Additionally, the valve seats 18 can be integrally formed with the frame 350 of the docking station 10, while the sealing portions are separate components attached to the frame 350 of the docking station 10.

[0061] The sealing portion 310, valve seat 18, and one or more retaining portions 314 of the various docking stations herein can take a variety of different forms and characteristics. In Figs. 3A-3C, an expandable frame 350 provides the shape of the sealing portion 310, valve seat 18, and retaining portion 314. The expandable frame 350 can take a wide variety of different forms. The illustrated expandable frame 350 in Figs. 3A-3C has an end portion 362 having an inner diameter 364 and an outer diameter 366. An annular or cylindrical shaped outer portion or wall 368 extends downwardly from the outer diameter 366 of the end portion 362. An annular or cylindrical shaped valve seat or wall 18 extends downwardly from the inner diameter 364 of the end portion 362. In the illustrated example, the expandable frame 350 is an expandable lattice. The expandable lattice can be made in a variety of ways, for example, individual wires are connected to form a lattice, braided, cut from a sheet and then rolled or otherwise formed into the shape of the expandable frame, molded, cut from a cylindrical shaped tube (e.g., cut from Nitinol), other ways, or combinations thereof.

[0062] The frame 350 may be made from highly flexible metals, metal alloys, or polymers. Examples of metals and metal alloys that may be used include, but are not limited to, Nitinol and other shape memory alloys, Elgiloy, and stainless steel, although other metals and highly elastic or flexible non-metallic materials may also be used to make the frame 350. These materials may allow the frame to be compressed to a small size, and then when the compressive force is released, the frame will self-expand back to its pre-compressed diameter, and / or the frame may be expanded by the expansion of a device positioned inside the frame. The frame 350 may also be made from other materials and may be expandable and collapsible in different ways, such as, for example, mechanically expandable, balloon expandable, self-expandable, or a combination thereof.

[0063] The sealing portion can take a wide variety of different forms. In the example of Figures 3A-3C, the covering / material 21 is attached to a portion of the frame 350 to form the sealing portion 310. However, the sealing portion 310 can be formed in a wide variety of other ways. The covering / material 21 can be a fabric material, a polymeric material, or other material. The sealing portion 310 can take any form that prevents or inhibits blood flow around the outer surface of the valve 29 and through the docking station. In the example of Figures 3A, 3B, and 3C, the sealing portion 310 includes a covering / material 21 (e.g., a fabric or other covering material that can be the same or similar to other coverings / materials described herein) that extends to the valve seat 18. The covering / material 21 can be shaped and positioned in a variety of ways, for example, the covering / material can be configured to partially cover the valve seat 18, completely cover the valve seat 18, or not cover the valve seat 18 when the frame 350 is expanded. Also, the covering / material 21 (e.g., fabric or other covering material) forming the sealing portion 310 can extend radially outward to cover the end 362 of the frame 350 and can optionally extend (e.g., longitudinally, downward, etc.) to cover at least a portion of the annular outer portion or wall 368. The sealing portion 310 provides a seal between the docking station 10 and the inner surface 416 of the circulatory system (see FIG. 2). That is, the sealing portion 310 and the closed valve 29 prevent or inhibit blood from flowing in the direction indicated by the arrow 377. In the example of FIGS. 3A and 3B, blood is not inhibited from flowing in the direction indicated by the arrow 378 into the area 379 between the valve seat 18 and the annular outer portion or wall 368.

[0064] The valve seat can take a wide variety of different forms. The valve seat 18 is part of the frame 350 in the example of Figures 3A-3C. However, the valve seat 18 can be formed separately from the frame 350. The valve seat 18 can take any form that provides a support surface for implanting or retaining the valve 29 in the docking station 10 after the docking station 10 is implanted in the circulatory system. The valve seat can optionally be reinforced with a reinforcing material (e.g., sutures, wires, bands, collars, etc. that can surround the valve seat or a portion of the valve seat). The valve 29 is illustrated diagrammatically in Figure 3A, showing that the valve 29 can take a wide variety of different forms. Figure 3D illustrates a more specific example, where the valve 29 is a leaflet-type THV, such as the Sapien 3 valve available from Edwards Lifesciences. In one exemplary embodiment, the valve 29 is integrated with or replaces the valve seat 18 such that the docking station 10 is configured as a transcatheter valve that is delivered as a single unit in the same step (as opposed to first implanting the docking station and then implanting a separate valve / THV into the docking station). Optionally, any of the docking stations described herein may be formed as a valve or THV, e.g., with valve tissue or other valve material integrated into the docking station.

[0065] The retaining portion 314 can take a wide variety of different forms. For example, the retaining portion 314 can be any structure that sets the position of the docking station 10 in the circulatory system. For example, the retaining portion 314 can press against or into an inner surface 416 or contour, or can extend around an anatomical structure of the circulatory system to set and maintain the position of the docking station 10. The retaining portion 314 can be part of or define a portion of the body, and / or the sealing portion or the retaining portion 314 of the docking station 10 can be a separate component that is attached to the body of the docking station. The docking station 10 can include a single retaining portion 314, or two or more retaining portions. The retaining portion 314 can include friction enhancing features as discussed above.

[0066] 3A-3C, the retaining portion 314 includes an annular outer portion or wall 368 of the frame 350. The shape set (e.g., a programmed shape of a shape memory material) of the annular outer portion or wall 368 can urge the annular outer portion or wall 368 radially outward into contact with / against an inner surface 416 of the circulatory system to hold the docking station 10 and valve 29 in the implanted position. In the illustrated embodiment, the retaining portion 314 is elongated, allowing a relatively small force to be applied to a large area of ​​the inner surface 416, while the valve 29 can apply a relatively large force to the valve seat 18. For example, the length of the retaining portion 314 can be 2, 3, 4, 5, or more than 5 times the outer diameter of the transcatheter valve. Applying a small radial outward force over a larger area can be sufficient to hold the docking station securely in place, and this design / configuration can allow the docking station to conform to the unique shape / size of the anatomical structure and avoid / reduce the possibility of damaging relatively weak natural tissue, such that the valve 29 can be securely held in a variety of locations and anatomical structures (e.g., the docking station of Figures 3A-3D can be used in the IVC, SVC, aorta, etc.).

[0067] In the example of Figs. 77 and 78, the retaining portion 314 can include an annular outer portion or wall 368 of the frame 350. The shape set (e.g., a programmed shape of a shape memory material) of the annular outer portion or wall 368 urges the annular outer portion or wall 368 radially outward into contact with / against the inner surface 416 of the aorta to hold the docking station 10 and valve 29 in the implanted position. In the example of Figs. 77 and 78, the shape set can also be selected to substantially match the shape of a portion of the aorta. As discussed above, the retaining portion 314 is elongated and can allow a relatively small force to be applied to a large area of ​​the inner surface 416, while the valve 29 can apply a relatively large force to the valve seat 18.

[0068] 4A-4D are schematic illustrations of an exemplary placement of the docking station 10 and valve 29 in the circulatory system. With reference to FIG. 4A, the docking station 10 is in a compressed configuration and introduced to a placement site in the circulatory system. For example, the docking station 10 may be positioned at a placement site in the SVC, IVC, aorta, or elsewhere. With reference to FIG. 4B, the docking station 10 is expanded in the circulatory system such that the sealing portion 310 and the retaining portion 314 engage an inner surface 416 of a portion of the circulatory system. With reference to FIG. 4C, after the docking station 10 is placed, the valve 29 is in a compressed configuration and introduced into the valve seat 18 of the docking station 10. With reference to FIG. 4D, the valve 29 is expanded in the docking station such that the valve 29 engages the valve seat 18 and the seat 18 of the docking station supports the valve. The docking station 10 allows the valve 29 to operate within a range of expanded diameters for which the valve 29 is designed. In the examples shown herein, the docking station 10 is longer than the valve. However, in some embodiments, the docking station 10 can be the same length as the valve 29 or shorter than the valve 29. Similarly, the valve seat 18 can be longer than the valve 29 or shorter than the valve 29 or the same length as the valve 29.

[0069] 4E illustrates that an inner surface 416 of a circulatory system, such as an inner surface of a blood vessel or cardiac anatomy, can vary in cross-sectional size and / or shape along its length. In an exemplary embodiment, the docking station 10 is configured such that it can expand radially outward to various degrees along its length L to conform to the shape of the inner surface 416. In one exemplary embodiment, the docking station 10 is configured such that the sealing portion 310 and / or the retaining portion 314 engage the inner surface 416 even if the shape of the blood vessel or cardiac anatomy changes significantly along the length L of the docking station. The docking station is made from a highly elastic or flexible material, capable of accommodating large variations in anatomy.

[0070] 5A-5C and 6 illustrate an exemplary embodiment of an inflatable docking station, which is similar to the embodiment of FIGS. 3A and 3B, except that blood is inhibited from flowing into area 379 between valve seat 18 and annular outer portion or wall 368 in the direction indicated by arrow 378. Blood may be prevented or inhibited from flowing into area 379 in a variety of different ways. In the example of FIGS. 5A-5C, covering material 500 forms a closed toroid on frame 350. That is, covering material 500 covers end surface 362 and span 510 between end surface 362 and annular valve seat or wall 18. As such, covering material 500 prevents or slows the ingress of blood into area 379. 5A-5C and 6, the end surface 362 and the valve seat or wall 18 are offset and the span 510 is a conical or tapered ring with a hole in the center. In one exemplary embodiment, the annular outer portion or wall 368 and the end 362 of the valve seat or wall 18 are coplanar or substantially coplanar and the end surface 362 is a ring or disk with a hole in the center.

[0071] 7A, 7B, 8A, and 8B illustrate additional embodiments in which blood is inhibited from flowing between the valve seat 18 and the annular outer wall 368. In the example of FIGS. 7A and 7B, the inflatable docking station includes an outer frame ring 750 and a separate inner frame ring 752 instead of the unitary frame 350. A toroidal shaped foam piece 710 fills the space 712 between the outer frame ring 750 and the inner frame ring 752. The toroidal shaped foam piece 710 is illustrated as filling the entire volume defined by the rings 750, 752 and having the same height as the rings 750 and 752. However, in other exemplary embodiments, the height H1 of the foam piece 710 can be smaller or larger than the height H2 of the rings 750, 752. Similarly, although the expandable frame rings are illustrated as being of the same height, the height of each of the frame rings can be different, for example, the outer frame ring 750 can have a greater height to spread the retaining force across a greater area of ​​the interior surface 416. The inner frame ring 752 can have a smaller height to concentrate the force radially outward of the valve over a smaller area of ​​the inner frame ring 752.

[0072] 7A and 7B, the sealing portion 310 includes a foam piece 710 and an outer ring 750. The outer ring 750 also acts as the retaining portion 314 against the inner surface 416. The inner ring 752 acts as the valve seat 18.

[0073] The inner and outer expandable frames 750, 752 can take a wide variety of different forms. The expandable frames 750, 752 can be expandable lattices. The expandable lattices can be made from individual wires, cut from a sheet and then rolled or otherwise formed into the shape of the expandable frame, cut from a sheet in a cylinder / tube / cylindrical shape, molded, etc. The frames 750, 752 can be made from highly flexible metals, metal alloys, or polymers. Examples of metals and metal alloys that can be used include, but are not limited to, Nitinol and other shape memory alloys, Elgiloy, and stainless steel, although other metals and highly elastic or flexible non-metallic materials can also be used to make the frames 750, 752. These materials can allow the frames to be compressed to a small size, and then when the compressive force is released, the frame will self-expand back to its pre-compressed diameter, and / or the frame can be expanded by device / balloon inflation.

[0074] An example of an open cell foam that may be used to form the docking station foam piece 710 (or any other foam part described in this application) is a biocompatible foam such as polyurethane foam (e.g., as may be obtained from Biomerix, Rockville, MD). The docking station with foam piece 710 may be self-inflating and / or inflatable by an inflatable device to cause the docking station to engage the variable shaped inner surface 416.

[0075] 8A and 8B illustrate an exemplary embodiment of the docking station 10, which is substantially the same as the docking station of FIG. 7A and 7B, except that the inner frame ring 752 is omitted. In the example of FIG. 8A and 8B, the inner surface 810 of the foam piece 710 acts as the valve seat 18. The inner surface 810 of the foam piece 710 can form the valve seat in a variety of different ways. For example, the inner surface 810 can be made to be substantially inelastic or not expandable from a predetermined deployed size. For example, the inner surface can be provided by an inelastic or substantially inelastic skin, which can be made from the same polymer as the foam (or another polymer), or the inner surface 810 can include bands, rings, or strands. The valve seat 18 can be any material capable of supporting the radial outward force of the transcatheter valve 29.

[0076] 9A and 9B illustrate an exemplary embodiment of a docking station 10, which is substantially similar to the docking station of FIGURES 8A and 8B, except that the outer frame ring 750 is omitted. In the example of FIGURES 9A and 9B, the outer surface 910 of the foam piece 710 acts as the sealing portion 310 and the retaining portion 314.

[0077] Figure 10 is a perspective view of a docking station 10 including a foam piece 710. The docking station of Figure 10 can include both an inner frame ring 752 and an outer frame ring 750, only the outer frame ring 750, only the inner frame ring 752, or no frame rings.

[0078] Figures 6-10 may be separate docking stations or may form a portion of another docking station, for example one of the docking stations described / shown elsewhere herein. For example, the embodiment shown in Figures 6-10 may be used as or form, and may be integral with or attached to, either end portion (e.g., the area including and around the valve seat) of the docking stations shown in Figures 3A-3D, 12-18, 32-36, 42-45 (which may be used at either or both ends), and 60A-60J, etc.

[0079] Optionally, the docking station frame 350 in various embodiments herein may be made of an elastic or superelastic material or metal. One such metal is Nitinol. When the frame 350 of the docking station 10 is made of a lattice of metal struts, the body can have spring properties. Referring to FIG. 11, like a spring, when the frame 350 of the docking station 10 is unconstrained and allowed to relax to its maximum diameter, the frame of the docking station applies little or no radial outward force. When the frame 350 of the docking station 10 is compressed, like a spring, the radial outward force applied by the docking station increases.

[0080] As illustrated by FIG. 11, in one exemplary embodiment, the relationship of the radially outward force of the docking station frame 350 to the diameter of the docking station is non-linear, although it could be linear. In the example of FIG. 11, curve 1150 illustrates the relationship between the radially outward force exerted by the docking station 10 and the compressed diameter of the docking station. In region 1152, curve 1150 has a low slope. In this region 1152, the radially outward force is low and changes by a small amount. In one exemplary embodiment, region 1152 corresponds to a diameter between 25 mm and 40 mm, for example, between 27 mm and 38 mm. The radially outward force is low in region 1152, but is not zero. In region 1154, curve 1150 has a higher slope. In this region 1154, the radially outward force increases significantly when the docking station is compressed. In one exemplary embodiment, the body of the stent is constructed to be in a region of low slope 1152 for both the largest and smallest vessels accommodated by the docking station 10. This allows the sealing portion 310 and retaining portion 314 to apply only a small radially outward force to the inner surface 416 of the circulatory system over a wide range of implantation diameters.

[0081] The docking station frame 350 can take a wide variety of different forms. Figures 12, 13, and 14 illustrate an exemplary embodiment of a docking station frame. In Figure 12, a portion of the valve seat 18 is omitted, but the frame includes a leg 1250 for supporting or forming a portion of the valve seat 18. In Figures 13 and 14, two examples of the valve seat 18 are shown connected to the leg 1250. In Figure 13, the valve seat 18 includes a separate valve seat component that is attached to the leg 1250. In Figure 14, the valve seat 18 is integrally formed with the leg 1250. In other embodiments, the valve seat 18 is replaced / integrated with the valve / THV 29, and the docking station 10 and the valve / THV are constructed and deployed as a single unit. In FIG. 14, a portion of the annular outer wall 368 has been removed to reveal the integrally formed valve seat 18 .

[0082] In one exemplary embodiment, the thickness of the strut 1200 of the frame varies. A variety of different portions of the strut 1200 can vary, and the strut can vary in different ways. With reference to Figures 12A and 12B, in one exemplary embodiment, the strut 1200 has a first thickness T1 and a second thickness T2. In the illustrated example, the strut 1200 at the annular wall portion 314 has a first thickness T1, and the strut portion or link 1202 of the strut 1200 forming the end 362 has a second thickness T2. In this example, the thickness T2 is less than the thickness T1. This reduced thickness allows the end 362 to bend or flex more easily and to connect the annular outer portion or wall 368 to the valve seat 18. In the illustrated example, the thicknesses T1, T2 are measured in a radially outward direction (i.e., measured from the inner surface to the outer surface of the frame 350). In one exemplary embodiment, the width of the strut 1200 is also reduced along with the thickness reduction, or optionally the width of a strut portion may be reduced instead of the thickness reduction. Thickness T2 can be 90% or less of thickness T1, thickness T2 can be 80% or less of thickness T1, thickness T2 can be 70% or less of thickness T1, thickness T2 can be 60% or less of thickness T1, thickness T2 can be half or less of thickness T1, thickness T2 can be 40% or less of thickness T1, thickness T2 can be 30% or less of thickness T1, thickness T2 can be ¼ or less of thickness T1, or thickness T2 can be 20% or less of thickness T1.

[0083] In the illustrated example, the entire strut portion or link 1202 of the strut 1200 forming the end 362 has the second thickness T2. However, in other embodiments, only a portion of the portion / link 1202 forming the end 362 has a reduced thickness. For example, the thickness of the portion / link 1202 can have thickness T2 at the apex or vertex 1204 of the illustrated bend 1206, while another part can have thickness T1. In one embodiment, a taper 1210 transitions the strut 1200 or strut portion / link 1202 from thickness T1 to thickness T2. In one embodiment, the taper is more gradual (e.g., occurs over a greater distance or length) and extends into the bend 1206 of the link. Also, the thickness can increase (e.g., be tapered) in the area from the apex or vertex 1204 to the valve seat 18 or in the area where the valve seat will be attached.

[0084] The length of the retaining portion 314 in Figures 12-13 is shown as being multiples of both the length / height of the valve seat and the diameter of the valve seat. As previously discussed, this configuration applies a relatively small radial outward force over a larger area to the interior surface of the circulatory system, sufficient to secure the docking station in place against the interior surface. Furthermore, this design / configuration allows the docking station to conform to the unique shape / size of anatomical structures that are more or less expanded in many different locations, adjusting to the contours (e.g., bulges, narrowed areas, constrictions, etc.) of the interior surface of the circulatory system (e.g., blood vessels) and contacting more of the interior surface. In one embodiment, the docking station and frame are configured such that when implanted, all or most of the outer surface of the docking station or frame contacts the interior surface of the circulatory system (even when the shape is irregular or changing). This also helps to avoid / reduce the possibility of damaging weaker natural tissues (e.g., by having too much localized force and / or pressure in one, two or more specific locations), thereby allowing the valve 29 to be securely held in a variety of locations and anatomical structures.

[0085] For example, the frames shown in Figures 12, 13, and 14 are configured such that a docking station incorporating the frame can conform to the internal shape of the circulatory system when expanded inside a blood vessel, such that the expandable frame can expand in multiple locations (e.g., 2, 3, 4, 5, 6, 7, 8, or more) to conform to multiple bulges in the circulatory system, and / or can contract (e.g., expand less, have a smaller diameter, etc.) in multiple locations (e.g., 2, 3, 4, 5, 6, 7, 8, or more) to conform to multiple narrowed regions of the circulatory system. Further, regardless of whether the natural anatomical structure is altered or more uniform, the frame is configured such that when a docking station incorporating the frame expands within the circulatory system, a majority (e.g., greater than 50%), greater than 60%, greater than 70%, greater than 80%, 50-90% or more of the outer surface of the docking station contacts the inner surface of the circulatory system and distributes pressure and force exerted by the docking station onto the inner surface over the portion or length of the outer surface of the docking station that is in contact with the inner surface.

[0086] 15 and 16, in one exemplary embodiment, the strut portions or links 1202 forming the ends 362 of the frame 350 are twisted or otherwise angled. The portions / links 1202 may be twisted in a wide variety of different manners and may be twisted along their entire length or along only a portion of their length. The twist 1500 aids in crimping or compressing the frame 350. In the illustrated example, the twist 1500 is included at or near (e.g., adjacent to) the junction 1510 of the portion / link 1202 and the annular outer portion or wall 368 and at or near (e.g., adjacent to) the junction 1520 of the portion / link 1202 and the valve seat 18. However, in other embodiments, the twist 1500 may be provided at only one of the junctions 1510 and 1520. In the illustrated example, the twist 1500 is a 90 degree twist, forming a total of 180 degree twist. At the junction 1510, the thickness T1 is greater than the width W1 of the portion / link 1202. At the junction 1520, the thickness T2 is greater than the width W2 of the portion / link 1202. Due to the two twists 1500, at the apex 1204, the thickness T3 can be less than the width W3 even though the portion / link 1202 is uniform at the apex 1204. That is, due to the twist 1500, the widths W1, W2 at the junctions 1510, 1520 can be the thickness T3 at the apex 1204, and the thicknesses T1, T2 at the junctions 1510, 1520 can be the width W3.The thickness T3 can be 90% or less of the width W3, the thickness T3 can be 80% or less of the width W3, the thickness T3 can be 70% or less of the width W3, the thickness T3 can be 60% or less of the width W3, the thickness T3 can be half or less of the width W3, the thickness T3 can be 40% or less of the width W3, the thickness T3 can be 30% or less of the width W3, the thickness T3 can be ¼ or less of the width W3, or the thickness T3 can be 20% or less of the width W3. Optionally, twists 1500 and strut portions / links 1202 having a uniform thickness or a thickness equal to the other struts 1200 of the frame can be used.

[0087] The twist 1500 makes it easier to crimp or compress the frame 350. For example, the thinner thickness T3 at the apex 1204 makes it easier for the sections / links 1202 to bend at the apex 1204 and along their length. In addition, the angle and / or twist 1500 facilitates an offset / rotation 1550 of the valve seat 18 relative to the annular outer portion or wall 368. This offset / rotation 1550 reduces the amount of bending and axial outward movement 1560 required when compressing or crimping the frame 350. As a result, the radius of curvature of the apex 1204 of the compressed or crimped frame is larger than it would be if the twist 1500 were not included. Because the radius of curvature is increased, the stress on the apex 1204 is reduced when the frame is compressed or crimped.

[0088] 17-19, in one exemplary embodiment, the frame 350 includes a valve seat 18 that is offset or rotated 1700 relative to the annular outer portion or wall 368. This offset or rotation 1700 angles the portion / link 1202 and / or twists the portion / link 1202. The offset / rotation 1700 assists in crimping or compressing the frame 350. Any degree of offset or rotation may be implemented. For example, compared to the strut portions / links 1202 of FIG. 13, which extend directly from the annular outer portion or wall 368 toward a longitudinal axis or central axis A (e.g., an axis parallel to and within the center of the outer wall 368) that runs longitudinally through the center of the docking station, the offset / rotation 1700 can optionally cause each of the strut portions / links to be angled 80 degrees or less, 70 degrees or less, 60 degrees or less, 50 degrees or less, 40 degrees or less, 30 degrees or less, 20 degrees or less, or 10 degrees or less relative to a radial line between the longitudinal axis or central axis A and the juncture of the strut portion to the outer wall (e.g., relative to the link or strut portion shown in FIG. 13 which is parallel to such radial line).

[0089] In Figures 17-19, at junction 1710, thickness T1 is less than width W1 of strut 1200. At junction 1720, thickness T2 is less than width W2 of strut 1200. At apex 1204, thickness T3 is also less than width W3. In one exemplary embodiment, widths W1, W2, and W3 are all the same. In one exemplary embodiment, thicknesses T1, T2, and T3 are all the same. The thickness T3 can be 90% or less of the width W3, the thickness T3 can be 80%% or less of the width W3, the thickness T3 can be 70%% or less of the width W3, the thickness T3 can be 60%% or less of the width W3, the thickness T3 can be half % or less of the width W3, the thickness T3 can be 40%% or less of the width W3, the thickness T3 can be 30% or less of the width W3, the thickness T3 can be 1 / 4% or less of the width W3, or the thickness T3 can be 20% or less of the width W3.

[0090] The offset / rotation 1700 makes it easier to crimp or compress the frame 350. For example, the offset / rotation 1700 reduces the amount of bending and axial outward movement 1760 required when compressing or crimping the frame 350. As a result, the radius of curvature of the apexes 1204 of the compressed or crimped frame is larger than it would be without the offset / rotation 1700. Because the radius of curvature is increased, stress on the apexes 1204 is reduced when the frame is compressed or crimped.

[0091] 20A-20C, in some exemplary embodiments, the apex 1204 of the strut portion or link 1202 (see FIG. 12) is shaped to facilitate compression or crimping of the frame 350. The apex 1204 can have a wide variety of different shapes. In the example of FIG. 20A, the apex includes a sharp bend 2000. The leg portion 2010 forms an acute angle β, such as less than 60 degrees, less than 45 degrees, or less than 30 degrees. In the example of FIG. 20B, the apex 1204 includes a rounded end or tip 2020 that extends upwardly and transitions into the two leg portions 2010 at two bends 2022. The rounded end or tip 2020 is substantially circular. For example, the rounded end or tip may be formed by an arc of 180 degrees to 300 degrees (or any subrange). The leg portion 2010 forms an acute angle θ, e.g., less than 60 degrees, less than 45 degrees, less than 30 degrees, less than 20 degrees, or less than 10 degrees. In the example of FIG. 20C, the apex portion 1204 includes a downwardly extending rounded end 2030, two upwardly extending rounded portions 2032, and two leg portions 2010. The downwardly extending end 2030 is substantially circular. For example, the end 2030 may be formed by an arc of 180 degrees to 300 degrees (or any subrange). The upwardly extending rounded portions 2032 are also substantially circular. For example, the upwardly extending rounded portion may be defined by an arc of 180 degrees to 300 degrees (or any subrange). The leg portion 2010 forms an acute angle α, e.g., less than 60 degrees, less than 45 degrees, less than 30 degrees, less than 20 degrees, or less than 10 degrees, etc.

[0092] 21A-21H illustrate crimping of a docking station frame 350, such as the docking station frame illustrated by FIGS. 17-19, for installation into a delivery catheter (see, for example, delivery catheter 2200 in FIG. 22A). Depending on the implantation site, the catheter can be flexible or rigid. A rigid or substantially rigid catheter can be used to access the inferior vena cava IVC or superior vena cava SVC. A relatively straight percutaneous route to the inferior vena cava IVC can be used. In that example, the crimping device 2100 includes a housing 2101 and a wedge-shaped driving member 2102. In FIG. 21A, the docking station frame 350 is in a fully or substantially fully expanded state inside the wedge-shaped driving member 2102. In this position, both the annular outer portion or wall 368 and the valve seat 18 are fully expanded. The strut portions / links 1202 are shown angled in a generally clockwise direction 2110 as they extend from the valve seat 18 to the annular outer portion or wall 368. Optionally, the portions / links 1202 can be angled in a generally counterclockwise direction (i.e., opposite the clockwise direction 2110) as they extend from the valve seat 18 to the annular outer portion or wall 368 (crimping would be similar to that shown in Figures 21A-21H but on the opposite side).

[0093] In Figure 21B, the wedge-shaped driving member 2102 begins to move the annular outer portion 368 or wall radially inward. As the annular outer portion 368 moves radially inward, the joint 1710 (see Figure 17) moves radially inward and the strut portion / link 1202 pushes the top end 2120 of the valve seat 18 radially inward while the bottom / proximal end 2122 of the valve seat remains substantially expanded.

[0094] In FIG. 21C, the wedge-shaped driving member 2102 continues to move the annular outer portion 368 or wall radially inward. As the annular outer portion 368 moves radially inward, the joint 1710 (see FIG. 17) continues to move radially inward. The strut portion / link 1202 continues to press the top end 2120 of the valve seat 18 radially inward, while the bottom end 2122 of the valve seat remains substantially expanded. As can be seen by comparing FIGS. 21A-C, the orientation of the portion / link 1202 has changed such that the angle in the clockwise direction 2110 is reduced, eliminated, or the portion / link 1202 extends in a counterclockwise direction. When the frame 350 is compressed or crimped, the radius of curvature of the apex 1204 becomes smaller.

[0095] In FIG. 21D, the wedge-shaped driving member 2102 continues to move the annular outer portion 368 or wall radially inward. As the annular outer portion 368 moves radially inward, the joint 1710 (see FIG. 17) continues to move radially inward. The portion / link 1202 holds the top end 2120 of the valve seat 18 substantially closed, while the bottom end 2122 of the valve seat remains open. In FIG. 21D, the bottom end 2122 of the valve seat comes into contact with the annular outer portion 368. The orientation of the strut portion / link 1202 now clearly changes from a clockwise direction 2110 to a counterclockwise direction 2130 as they extend from the valve seat 18 to the annular outer portion or wall 368. The radius of curvature of the apex 1204 continues to become smaller. However, the angled orientation of portion / link 1202 helps maintain a greater distance between joints 1710 and 1720 and increases the radius of curvature of apex 1204 relative to non-angled portion 2102 (which is crimped).

[0096] 21E, the wedge-shaped driving member 2102 drives the annular outer portion 368 and the bottom end 2122 of the valve seat 18 radially inward. The orientation of the portion / link 1202 is in a counterclockwise direction 2130. The radius of curvature of the apex portion 1204 continues to get smaller.

[0097] 21F, the wedge-shaped driving member 2102 continues to drive the annular outer portion 368 and the bottom end 2122 of the valve seat 18 radially inward. The orientation of the portion / link 1202 is in a counterclockwise direction 2130. The radius of curvature of the apex portion 1204 continues to become smaller.

[0098] 21G, the wedge-shaped driving member 2102 continues to drive the annular outer portion 368 and the bottom end 2122 of the valve seat 18 radially inward. The orientation of the portion / link 1202 is in a counterclockwise direction 2130. The radius of curvature of the apex portion 1204 continues to become smaller.

[0099] The wedge shaped driving member 2102 continues to drive the annular outer portion 368 and the bottom end 2122 of the valve seat 18 radially inward. The radius of curvature of the apex 1204 continues to become smaller. The frame 350 is in a fully compressed or crimped state in FIG. 21H. The compressed or crimped frame 350 may be loaded into a catheter or sleeve / sheath for placement in a patient.

[0100] 22A-22C, 23A-23C, and 24A-24C, in some exemplary embodiments, the docking station 10 may be configured to curl back on itself when it is deployed from the catheter 2200. The docking station 10 illustrated by FIGS. 22A-22C and 23A-23C may be deployed within any of the interior surfaces 416 or implantation sites described herein. The docking station 10 illustrated by FIGS. 24A-24C is configured to be deployed within a native valve. FIGS. 22A-22C, 23A-23C, and 24A-24C generally illustrate a cross section of the docking station 10 deployed from the catheter 2200. The docking station 10 may be made from any combination of materials disclosed herein. For example, the docking station 10 may be made from a shape memory alloy frame, foam, fabric covering, or the like. The docking station 10 as shown defines a valve seat 18, a sealing portion 310, and a retaining portion 314. Embodiments shown only in cross section in this application may be assumed to have an annular or cylindrical shape.

[0101] Referring to Fig. 22A, during deployment, the docking station 10 first extends radially outward 2220 from the indwelling catheter 2200. Referring to Fig. 22B, the docking station 10 then extends or curls back 2222 toward the indwelling catheter. Referring to Fig. 22C, the docking station 10 then extends back upward 2224, overlapping the final portion 2226 of the docking station that will be deployed from the catheter 2200.

[0102] 23A-23C illustrate another exemplary embodiment of the docking station 10, which is configured to curl back on itself when it is deployed from the catheter 2200. The docking station 10 illustrated by FIGS. 23A-23C may be deployed within any of the interior surfaces 416 described herein. With reference to FIG. 23A, during deployment, the docking station 10 first extends radially outward 2220 from the indwelling catheter 2200. With reference to FIG. 23B, the docking station 10 then extends or curls back 2222 toward the indwelling catheter. With reference to FIG. 23C, the docking station 10 then extends back upward 2224, overlapping the docking station valve seat 18, with the final portion 2228 of the docking station to be deployed extending radially outward 2230 below the curled toroidal portion 2230.

[0103] 24A-24C illustrate another exemplary embodiment of the docking station 10, which is configured to curl back on itself when it is deployed from the catheter 2200. In the example of FIGS. 24A-24C, the docking station 10 is configured to curl back on itself and capture one or more leaflets 2400 of the native valve. For example, the docking station 10 may be configured to capture the leaflets of the mitral valve MV, the aortic valve AV, the tricuspid valve TV, or the pulmonary valve PV. With reference to FIG. 24A, from inside the leaflets 2400 of the native valve, the docking station 10 extends radially outward 2420 from the deployment catheter 2200, deploying outward of the leaflets 2400. With reference to FIG. 24B, the docking station 10 then extends or curls back 2422 toward and behind the leaflets 2400. 24C, the docking station 10 is then extended back 2424 and the leaflets are sandwiched or clamped 2426 between the valve seat 18 and a portion of the docking station 2428. The clamping secures the docking station 10 to the leaflets, and thereby to the native valve.

[0104] FIG. 25 illustrates an example of a strut configuration that may be used to create or incorporated into the curled docking station 10 of FIGS. 22A-22C and 24A-24C. In FIG. 25, the valve seat 18 is formed by an inner strut 2500. The inner strut 2500 extends from an end 2502 to a junction 2504 forming a generally diamond shaped opening 2506. The top and outer struts 2510 extend from the junction 2504 to a second end 2512. The top and outer struts 2510 form a continuous opening 2516. Optionally, the end 2512 can extend back up 2224 and overlap the end 2502.

[0105] 26-28 illustrate example strut configurations that may be used to create or incorporated into the curled docking station 10 of FIGS. 23A-23C. In FIG. 26, the valve seat 18 is formed by an inner strut 2600. The inner strut 2600 is elongated and extends (e.g., longitudinally and radially outward) to form a leg 2601 that extends to an end 2602. The inner strut also extends upward to a junction 2604 forming an opening 2606. The top and outer struts 2610 extend from the junction 2604 to a second end 2612. The top and outer struts 2610 form a continuous opening 2616. In one embodiment, the end 2612 extends back upward 2224 to overlap the leg 2601.

[0106] FIG 29 illustrates an exemplary embodiment of the docking station 10. The frame 350 or body can take a wide variety of different forms, and FIG 29 illustrates merely one of many potential configurations. In the example of FIG 29, the retaining portion 314 forms a relatively wider inlet portion 2912. A relatively narrower portion 2916 forms the seat 18. A tapered portion 2918 joins the wider portion 2912 and the seat 18.

[0107] In the example of FIG. 29, the frame 350 includes a plurality of metal struts 1200 that form cells 2904. In the example of FIG. 29, the cells of the retaining portion 314 are uncovered. A covering / material 21 (e.g., an impermeable material, a semi-permeable material, a material such as those discussed above, etc.), such as a cloth or fabric (FIG. 29) or a protective foam (FIG. 30), is provided over the narrow portion 2916, the tapered portion 2918, and the rounded or outer segment 3216 to form the sealing portion 310 of the docking station 10. The valve 29 expands within the narrow portion 2916, which forms the valve seat 18.

[0108] The docking station can be made from highly elastic or flexible materials to accommodate large variations in anatomy. For example, the docking station can be made from highly flexible metals, metal alloys, polymers, or open cell foams. An example of a highly elastic metal is Nitinol, but other metals and highly elastic or flexible non-metallic materials can also be used. The docking station 10 can be self-expandable, manually expandable (e.g., via a balloon), mechanically expandable, or a combination thereof. A self-expandable docking station 10 can be made from a shape memory material, such as, for example, Nitinol.

[0109] Referring to FIG. 29, in one exemplary embodiment, a band 20 extends around or is integrated into the waist or narrow portion 2916 to form a non-expandable or substantially non-expandable valve seat 18. The band 20 stiffens the waist and renders the waist / valve seat relatively non-expandable in its deployed configuration when the docking station is deployed and expanded. Optionally, the band 20 can extend over some or all of the narrow portion 2916. In the example of FIG. 29, the valve 29 is secured by the expansion of its collapsible frame into the valve seat 18 of the docking station 10. The non-expandable or substantially non-expandable valve seat 18 prevents the radial outward force of the valve 29 from being transmitted to the inner surface 416 of the circulatory system. However, in one exemplary embodiment, the waist / valve seat of the deployed docking station can optionally expand slightly in an elastic manner when the valve 29 is deployed against it. This optional elastic expansion of the waist 18 can exert pressure on the valve 29 and help hold the valve 29 in place in the docking station.

[0110] The band 20 can take a wide variety of different forms and can be made from a wide variety of different materials. For example, the band 20 can be made from PET, PTFE, ePTFE, one or more sutures, fabric, metal, polymer, biocompatible tape, or other relatively non-expandable material known in the art that is sufficient to maintain the shape of the valve seat 18 and to hold the valve 29 in place. The band can extend around the exterior of the stent or can be an integral part of it, such as when a fabric or another material is woven into or through the cells of the stent. The band 20 can be narrow (e.g., such as the suture band in FIG. 29) or wider. The band can be of various widths, lengths, and thicknesses. In one non-limiting example, the valve seat 18 is between 15-35 mm wide, between 18-31 mm wide, between 20-29 mm wide, etc., although the diameter of the valve seat can vary from the previous example, should it be within the operating range of the particular valve 29 that will be secured within the valve seat 18. The valve 29 can optionally expand slightly around either side of the valve seat when docked in the docking station, and this aspect (sometimes referred to as a "dog bone" (e.g., due to the shape it forms around the valve seat or band)) can help hold the valve in place.

[0111] FIG. 31 illustrates the docking station 10 of FIG. 29 implanted in a circulatory system, such as in the inferior vena cava IVC. In the example of FIG. 31, the narrow portion 2916 and / or tapered portion 2918 extend into the right atrium RA, and the retaining portion 314 (hidden in FIG. 31) is held in place in the inferior vena cava IVC. The reduced size of the narrow portion 2916 can prevent the docking station 10 from contacting an internal surface of the circulatory system or natural tissue (e.g., of the right atrium RA). The covering 21 illustrated by FIG. 30 can be used to cushion any possible contact between the narrow portion 2916 and the circulatory system or natural tissue (e.g., the right atrium). The sealing portion 310 provides a seal between the docking station 10 and an internal surface 416 of the circulatory system, such as at the junction between the inferior vena cava IVC and the right atrium.

[0112] In the example of FIG. 31 , the sealing portion 310 is formed by providing a coating / material 21 over the frame 350 or a portion thereof. Among other things, the sealing portion 310 can include a narrow portion 2916, a tapered portion 2918, and / or a retaining portion 314. In an exemplary embodiment, the coating / material 21 (e.g., an impermeable material, a semi-permeable material, a fabric, a polymer, a foam, a wax, etc.) covers the narrow portion 2916, the tapered portion 2918, and optionally a portion of the retaining portion 314. In one embodiment, the coating / material can be configured to encourage or enhance tissue ingrowth (e.g., the coating / material 21 can have a large surface area and / or can be hydrophilic to enhance tissue ingrowth). This provides a seal, making the docking station impermeable or substantially impermeable from the sealing portion 310 to the seal between the valve 29 at the valve seat 18 and the docking station 10. As such, blood flowing in inflow direction 12 towards outflow direction 14 is directed towards valve seat 18 and valve 29 when seated / placed within the valve seat.

[0113] As one non-limiting example, when the docking station 10 is placed in the inferior vena cava (which is a large blood vessel), a significant volume of blood flowing through the vein is diverted into the valve 29 by the covering 21. The covering 21 can be fluid impermeable or can become fluid impermeable (e.g., via tissue ingrowth) so that blood cannot pass through. A variety of other covering materials (including any of the materials described elsewhere herein) can also be used, such as foams (FIG. 30) or fabrics that have been treated with a coating that is impermeable to blood, polyester, or engineered biological materials, such as pericardium. More of the docking station frame 350 can be provided with material 21, forming a relatively large impermeable portion.

[0114] FIG. 32 illustrates an exemplary embodiment of the docking station 10. The docking station illustrated by FIG. 32 is similar to the docking station illustrated by FIG. 29, except that an outer segment 3216 extends from the narrow portion 2916. The outer segment 3216 is shaped to be atraumatic to the interior surface 416 or natural anatomical structures. For example, the outer segment 3216 can be round or toroidal. The round or outer segment 3216 can take a wide variety of different forms. For example, the round or outer segment 3216 can include a plurality of metal struts that form cells and form part of or are attached to the frame 350. The round or outer segment 3216 can be made of a foam material. FIG. 32 illustrates one of many potential configurations.

[0115] 32, the retaining portion 314 forms a relatively wider inlet portion 2912. A relatively narrower portion 2916 forms the seat 18. A tapered portion 2918 joins the wider portion 2912 and the seat 18. A rounded or outer segment 3216 extends radially outward from the relatively narrower portion 2916.

[0116] In the example of FIG. 32, the frame 350 includes a plurality of metal struts 1200 forming cells 2904. In the example of FIG. 32, the cells of the retaining portion 314 are uncovered. A covering / material 21 (e.g., an impermeable material, a semi-permeable material, a material such as those discussed above, etc.), such as a cloth or fabric or a protective foam, may be provided over the narrow portion 2916, the tapered portion 2918, and the rounded or outer segment 3216. The covering / material 21 extending over the frame 350 forms the sealing portion 310 of the docking station 10. The valve 29 expands into the narrow portion 2916 forming the valve seat 18.

[0117] The docking station can be made from highly elastic or flexible materials to accommodate large variations in anatomy. For example, the docking station can be made from highly flexible metals, metal alloys, polymers, or open cell foams. An example of a highly elastic metal is Nitinol, but other metals and highly elastic or flexible non-metallic materials can also be used. The docking station 10 can be self-expandable, manually expandable (e.g., via a balloon), mechanically expandable, or a combination thereof. A self-expandable docking station 10 can be made from a shape memory material, such as, for example, Nitinol.

[0118] Referring to FIG. 32, in one exemplary embodiment, a band 20 extends around or is integrated into the waist or narrow portion 2916 to form a non-expandable or substantially non-expandable valve seat 18. The band 20 can also extend over other portions of the docking station as well. The band 20 stiffens the waist and renders the waist / valve seat relatively non-expandable in its deployed configuration when the docking station is deployed and expanded. In the example of FIG. 32, the valve 29 is secured by the expansion of its collapsible frame into the valve seat 18 of the docking station 10. The non-expandable or substantially non-expandable valve seat 18 prevents the radially outward force of the valve 29 from being transmitted to the inner surface 416 of the circulatory system. However, in one exemplary embodiment, the waist / valve seat of the deployed docking station can optionally expand slightly in an elastic manner when the valve 29 is deployed against it. This optional elastic expansion of the waist 18 can exert pressure on the valve 29 and help hold the valve 29 in place in the docking station.

[0119] The band 20 can take a wide variety of different forms and can be made from a wide variety of different materials. The band 20 can be made from PET, one or more sutures, fabric, metal, polymer, biocompatible tape, or other relatively non-expandable material known in the art that is sufficient to maintain the shape of the valve seat 18 and to hold the valve 29 in place. The band can extend around the exterior of the stent or be an integral part of it, such as when a fabric or another material is woven into or through the cells of the stent. The band 20 can be narrow (such as the suture band in FIG. 32) or wider. The band can be of various widths, lengths, and thicknesses. In one non-limiting example, the valve seat 18 is between 27-28 mm wide, but the diameter of the valve seat can vary from the previous example, as long as it is within the operating range of the particular valve 29 that will be secured in the valve seat 18. The valve 29 is optionally allowed to expand slightly around either side of the valve seat when docked in the docking station, for example in an hourglass shape.

[0120] Fig. 33 illustrates the docking station 10 of Fig. 32 implanted in the circulatory system, such as in the inferior vena cava IVC. In Fig. 33, the outer segment 3216, narrow portion 2916, and / or tapered portion 2918 extend into the right atrium RA, with the retaining portion 314 held in place in the inferior vena cava IVC. Any contact between the interior surface of the right atrium RA and the docking station 10 is made by the outer segment 3216. The shape and atraumatic configuration of the outer segment 3216 protects the interior surface of the right atrium RA.

[0121] The sealing portion 310 provides a seal between the docking station 10 and an interior surface 416 of the circulatory system, such as at the junction between the inferior vena cava IVC and the right atrium. In the example of FIG. 33, the sealing portion 310 is formed by providing a coating / material 21 (which can be the same as or similar to other coatings / materials described elsewhere herein) over the frame 350 or a portion thereof. Among other things, the sealing portion 310 can include the narrow portion 2916, the outer segment 3216, the tapered portion 2918, and / or a covered portion of the retaining portion 314. In an exemplary embodiment, the coating / material 21 covers the outer segment 3216, the narrow portion 2916, the tapered portion 2918, and optionally a portion of the retaining portion 314. In one embodiment, the coating / material may be configured to encourage or enhance tissue ingrowth (e.g., the coating / material 21 may have a large surface area and / or may be hydrophilic to enhance tissue ingrowth). This provides a seal, making the docking station impermeable or substantially impermeable from the sealing portion 310 to the seal between the valve 29 at the valve seat 18 and the docking station 10. As such, blood flowing in the inflow direction 12 towards the outflow direction 14 is directed to the valve seat 18 (and the valve 29 when seated in the valve seat).

[0122] As one example, when the docking station 10 is placed in the inferior vena cava IVC (which is a large blood vessel), a significant volume of blood flowing through the vein is diverted into the valve 29 by the covering 21. The covering 21 can be fluid impermeable or can become fluid impermeable (e.g., via tissue ingrowth) so that blood cannot pass through. A variety of biocompatible covering materials can be used, such as any of the materials described elsewhere herein, including foams or fabrics that have been treated with a coating that is impermeable to blood, polyester, or engineered biological materials, such as pericardium. More of the docking station frame 350 can be provided with the covering / material 21, forming a relatively large impermeable portion.

[0123] 34 and 35 illustrate an exemplary embodiment in which the outer segment 3216 of the docking station 10 illustrated by FIG. 32 is formed as part of the frame 350. In the example of FIGS. 34 and 35, the valve seat 18 is formed by an inner strut 3400. The retaining portion 314 is formed by a lower strut 3410. The lower strut 3410 extends longitudinally and radially outward from the inner strut 3400. The lower strut 3410 terminates at a lower end 3412 of the docking station 10. The outer segment 3216 is formed by top and outer struts 3520 that extend radially outward 3450 and then downward 3452 and inward 3454.

[0124] In FIG. 35, the entire frame 350 includes a plurality of metal struts 1200 forming cells 2904. In FIG. 32, the cells of the retaining portion 314 are uncovered. A covering / material 21 (which can be the same or similar to the covering / material 21 previously discussed), such as cloth or fabric or protective foam, can be provided on the valve seat 18 (i.e., on the inside or outside of the strut 1200), the round or outer segment 3216, and a portion of the retaining portion 314. For example, referring to FIG. 35, all of the upper portion 3550 of the line 3530 can be covered and the lower portion 3552 of the line 3530 can be uncovered. The line 3530 can be adjusted to ensure that the material 21 extends to the area of ​​contact with the inner surface 416 (e.g., the area expected to be in contact with the inner surface 416 at the junction between the IVC and the right atrium).

[0125] The docking station illustrated by Figs. 34 and 35 can be made from highly elastic or flexible materials to accommodate large variations in anatomy. For example, the docking station 10 can be made from highly flexible metals, metal alloys, polymers, or open cell foams. An example of a highly elastic metal is Nitinol, but other metals and highly elastic or flexible non-metallic materials can also be used. The docking station 10 can be self-expandable, manually expandable (e.g., via a balloon), mechanically expandable, or a combination thereof. A self-expandable docking station 10 can be made from a shape memory material such as Nitinol.

[0126] FIG. 36 illustrates an exemplary embodiment of an expandable docking station 10 with a retaining portion 314 disposed in the inferior vena cava IVC and a valve seat 18 disposed in the right atrium RA. The expandable docking station 10 includes one or more sealing portions 310, a valve seat 18, and one or more retaining portions 314. In FIG. 36, the docking station 10 is configured to provide a seal 3610 at the atrial-venous junction 3612. The seal 3610 at the atrial-venous junction 3612 can be provided in a variety of different ways. In FIG. 36, the frame 350 transitions 3616 radially outward from the retaining portion 314 toward an end 3617 of the docking station 10 to form an enlarged portion or skirt 3618. The enlarged portion or skirt 3618 is flexible such that the portion of the docking station that contacts the surface of the atrium is soft. The enlarged portion or skirt may also be covered with foam or other material to further soften the area of ​​potential contact between the atrium and the docking station 10 .

[0127] The sealing portion 310 is configured to prevent or inhibit blood flow where the atrial-venous junction 3612 meets the enlarged portion or skirt 3618 when implanted. An additional sealing portion 310' is provided to prevent or inhibit blood from flowing between the valve 29 and the docking station. In the example of FIG. 36, the additional sealing element 310' is disposed on the portion of the frame 350 that forms the valve seat 18 and extends to the sealing element 310. As such, the two sealing elements 310, 310' prevent or inhibit blood from flowing around the outside of the transcatheter valve 29. In another exemplary embodiment, the sealing element 310 can cover the entire enlarged portion 3618 or skirt and can extend into the area of ​​the valve seat 18, eliminating the need for a second sealing element 310'.

[0128] The sealing portion can take a wide variety of different forms. In the example of FIG. 36, a fabric, polymer, or other covering is attached to a portion of the frame 350 to form the sealing portion 310. However, the sealing portion 310 can be formed in a wide variety of other manners. The sealing portion 310 can take any form that prevents or inhibits blood from flowing through the docking station frame and around the outer surface of the valve 29.

[0129] The retaining portion 314 of the embodiment of FIG. 36 can take a wide variety of different forms. For example, the retaining portion 314 can be any structure that sets the position of the docking station 10 in the circulatory system and can be the same as or similar to the retaining portion 314 discussed elsewhere in this disclosure. For example, the retaining portion 314 can press against or into the inner surface 416 or can extend around an anatomical structure of the circulatory system to set the position of the docking station 10. The retaining portion 314 can be part of or define a portion of the body and / or sealing portion of the docking station 10, or the retaining portion 314 can be a separate component that is attached to the body of the docking station. The docking station 10 can include a single retaining portion 314, two of these, or more than two.

[0130] 36, the retaining portion 314 includes an annular outer portion or wall 368 of the frame 350. The shape of the annular outer portion or wall 368 urges the annular outer portion or wall 368 radially outwardly into contact with an inner surface 416 of the circulatory system to maintain the docking station 10 and valve 29 in the implanted position. The retaining portion 314 can be elongated to allow a small force to be applied to a large area of ​​the inner surface 416. For example, the length of the retaining portion 314 can be 2, 3, 4, 5, or more than 5 times the outer diameter of the transcatheter valve.

[0131] 37-41, in one exemplary embodiment, the frame 350 used in the docking station 10 includes springs or spring / flexible segments 3700, allowing the frame 350 to bend. The springs / flexible segments 3700 allow the stent segments to anchor onto the vessel wall while allowing the docking station to curve if necessary. In the example of FIG. 37, the frame or stent segments 3702 are attached to each other by multiple springs or spring / flexible segments 3700. Any of the frames shown and described herein can optionally have any combination of springs / flexible segments 3700 and frame or stent segments 3702. The springs / flexible segments 3700 can take a wide variety of different forms. Examples of springs / flexible segments 3700 include, without limitation, spring wire, springs constructed by selective material removal (see FIG. 40), compression springs, torsion springs, and / or tension springs.

[0132] In Figure 38, springs / flexible segments 3700 allow frame 350 to bend 3800 more easily. Frame 350 can bend in a wide variety of different ways. In the example of Figure 38, springs on one side 3802 are in tension and springs on another side 3804 are in compression, bending 3800 in the direction shown. Because multiple springs / flexible segments 3700 are provided in frame 350, the frame can bend easily in different directions along the length of frame 350.

[0133] 39 illustrates that the frame or stent segments 3702 are expandable 3900 and compressible 3902. By having separate frame or stent segments 3702 connected by spring / flexible segments 3700, the frame can more easily conform to vessels having various sizes. The combination of frame or stent segments 3702 and spring segments allows the frame to conform to vessels with varying vessel cross-sectional sizes, vessel cross-sectional shapes, and vessel flow shapes or paths.

[0134] FIG. 40 illustrates an exemplary embodiment in which the frame or stent segments 3702 are integrally formed with the spring / flexible segments 3700. For example, the frame or stent segments 3702 and the spring / flexible segments 3700 may be cut from a single piece of material, such as a shape memory alloy such as Nitinol. In the illustrated example, the stent segments 3702 include a matrix of interconnected struts 1200 that are joined to form cells 4000 with openings 4002. However, the stent segments 3702 may be formed with a wide variety of different cutting patterns. The illustrated spring segments 3700 are formed by cutting straps / struts 4010 with notches 4012. However, the spring / flexible segments 3700 may be formed with many different cutting patterns.

[0135] FIG. 41 illustrates an exemplary embodiment of a docking station 10 including two frame or stent segments 3702 connected by a spring / flexible segment 3700. In the example of FIG. 41, the docking station 10 is placed in a blood vessel 4100 that is curved and has a varying cross-sectional size. A first frame or stent segment 4110 expands 4112 to a first size to match the size of the blood vessel 4100 at the location where the first frame or stent segment is placed. A second frame or stent segment 4120 expands 4122 to a larger second size to match the size of the blood vessel 4100 at the location where the second frame or stent segment is placed. The blood vessel 4100 curves from the location of the first stent or frame segment 4110 to the location of the second stent or frame segment 4120. The springs / flexible segments 3700 allow the frame 350 to bend 4130 and conform to the curvature of the blood vessel 4100 .

[0136] 42-45 illustrate an exemplary embodiment in which two docking stations 10 are connected together by a connecting portion 4250 to form a dual docking station 4200. In the example of FIGs. 42-45, the dual docking station 4200 is configured such that a first docking station 4210 can be placed in the inferior vena cava IVC and a second docking station 4212 can be placed in the superior vena cava SVC. The docking stations 4210 and 4212 can be connected together in a wide variety of different manners.

[0137] The docking stations 4210, 4212 can take a wide variety of different forms. For example, the docking stations 4210, 4212 can be any of the docking stations 10 disclosed herein. The example of Figures 42-45 may incorporate one of the docking stations 10 illustrated by Figures 12-19 and 20A-20C. The docking stations 4210, 4212 can be the same, or the docking stations 4210, 4212 can be different sizes and / or types.

[0138] In one exemplary embodiment, one of the ends is not provided with a docking station. For example, the docking station 4210 may be positioned in the inferior vena cava IVC and the connecting portion 4250 and / or the inflatable frame 4110 (see FIG. 41 ) may extend into the superior vena cava SVC and stabilize the docking station 4210 without acting as a docking station. Similarly, the docking station 4212 may be positioned in the superior vena cava SVC and the connecting portion 4250 and / or the inflatable frame 4110 (see FIG. 41 ) may extend into the inferior vena cava IVC and stabilize the docking station 4212 without acting as a docking station.

[0139] The connecting portion 4250 can take a wide variety of different forms. In one exemplary embodiment, the connecting portion 4250 is constructed to allow blood to flow freely through the connecting portion. For example, the connecting portion 4250 can be an open cell frame 4260, as illustrated by FIG. 42. The connecting portion 4250 can include a spring portion 3700, as illustrated by FIG. 43. The connecting portion 4250 can include a wire 4262, as illustrated by FIG. 44. In one embodiment, the connecting portion 4250 includes an open cell frame 4260, a spring portion 3700, and / or a wire 4262. Referring to FIG. 45, in one embodiment, the connecting portion 4250 is configured to bend as it extends from the superior vena cava SVC to the inferior vena cava IVC. In the example of FIG. 45, the connecting portion 4250 is configured to be placed against the interior wall 450 of the right atrium RA. The connecting portion 4250 may be integrally formed with the docking stations 4210, 4212, or the connecting portion may be made separately from one or both of the docking stations 4210, 4212 and attached to the docking stations.

[0140] In one embodiment, the docking station 10 can include a sealing portion 310 and / or a retaining portion 314, or a combined sealing and retaining portion, which are radially expandable. The sealing portion 310 and / or the retaining portion 314 can be configured to expand in a wide variety of different manners. In the example of FIG. 46 and FIG. 47, the combined radially expandable sealing and retaining portion 4610 includes a material 4612, e.g., fabric, cloth, foam, etc., and a line or cord 4614. In FIG. 47, the line or cord 4614 is attached to the material 4612 such that pulling the line or cord 4614 causes the material 4612 to linearly retract, bunch, or fold like an accordion, thereby expanding radially outward as shown. The line or cord 4614 is shown taut in FIG. 47, representing pulling the line or cord (e.g., pulling the lower line / cord 4614 in the IVC down and pulling the upper line / cord 4614 in the SVC up, although other pulling directions / combinations are possible) to contract the material 4612 axially and expand the material 4612 radially. For example, a first end 4620 of the material 4612 may be attached to the frame 350. The line or cord 4614 may be attached to a second end 4630. The line or cord 4614 may be repeatedly threaded back and forth through the material 4612 as it extends from the first end 4620 to the second end 4630. As such, the material is squeezed and retracted in length L and expanded in radial thickness T.

[0141] The radially expandable sealing portion 310 and / or the retaining portion 314, or the combined sealing and retaining portion, may be implemented on any of the docking stations 10 disclosed herein. In the example of Fig. 46 and Fig. 47, the combined radially expandable sealing and retaining portion 4610 is provided on a stent or frame 4660 to form a docking station. The radially expandable portion extends around the circumference of the stent or frame 4660. The stent or frame 4660 can take a wide variety of different forms. For example, the stent or frame can be any conventional stent or frame or any of the frames 350 disclosed herein. In Fig. 46, the stent or frame 4660 is configured to extend from the superior vena cava SVC to the inferior vena cava IVC. However, in some embodiments, the stent or frame 4660 can be configured to engage and seal with only one inner surface area. The stent or frame 4660 can be configured to engage and seal with one or more interior surface areas of the heart H. For example, a stent or frame 4660 with one or more radially expandable portions 4610 can be configured to be placed in the inferior vena cava IVC, superior vena cava SVC, aorta, pulmonary artery, aortic valve AV, mitral valve MV, pulmonary valve PV, or tricuspid valve TV and act as a valve seat 18.

[0142] The stent or frame 4660 can take a wide variety of different forms. In the example of Figures 46 and 47, the stent or frame 4660 is disposed in the right atrium RA. In one embodiment, the stent or frame 4660, or a portion of the stent or frame 4660 in the right atrium, has an open configuration, allowing blood in the atrium to easily flow through the stent or frame 4660. For example, the stent or frame 4660 can take any of the forms illustrated by Figures 42-44.

[0143] The docking station profile illustrated by FIG. 48 is taken from U.S. patent application Ser. No. 15 / 422,354, entitled “Docking Station for a Transcatheter Heart Valve,” filed Feb. 1, 2017, and published as U.S. Patent Application Publication No. 2017 / 0231756, which claims priority to U.S. Provisional Patent Application No. 62 / 292,142, filed Feb. 5, 2016. These applications are incorporated herein by reference in their entireties. Any concepts, aspects, features, or other material disclosed by these applications may be used in combination with any of the embodiments disclosed in this application, for example, the docking station 10 illustrated by FIG. 48 may be configured to be placed in the aorta, IVC, and / or SVC.

[0144] Figure 49 illustrates an exemplary embodiment of a docking station 10 that is similar to the docking station illustrated by Figure 48, except that the radially outwardly extending end 4800 has been replaced with an end 4900 that does not extend radially outwardly. For example, the end 4900 could extend axially as shown, or could extend radially inward.

[0145] Fig. 50 illustrates an exemplary embodiment in which the docking station 10 illustrated by Fig. 48 or 49 is placed in the circulatory system, such as, for example, in the inferior vena cava IVC. In the example illustrated by Fig. 50, the entire docking station is held in place in the inferior vena cava IVC by a frame 350. The sealing portion 310 provides a seal between the docking station 10 and an interior surface 416 of the circulatory system, such as, for example, at the junction between the inferior vena cava IVC and the right atrium.

[0146] In the example of FIG. 50, the sealing portion 310 is formed by providing a coating / material over the frame 350 or a portion thereof. With reference to FIGS. 48 and 49, the sealing portion 310 can include one or both of the narrow portion 4916, the tapered portion 4918, and / or the retaining portion 314. In an exemplary embodiment, a coating / material (which can be the same or similar to other coatings / materials described elsewhere herein) covers the narrow portion 4916, the tapered portion 4918, and a portion of the retaining portion 314. In one embodiment, the coating / material can be configured to encourage or enhance tissue ingrowth (e.g., the coating / material can have a large surface area and / or can be hydrophilic to enhance tissue ingrowth). This makes the docking station impermeable or substantially impermeable from the sealing portion 310 to the seal between the valve 29 and the docking station 10 at the valve seat 18. As such, blood flowing in inflow direction 12 towards outflow direction 14 is directed towards valve seat 18 (and valve 29 when seated or disposed within the valve seat).

[0147] As one non-limiting example, when the docking station 10 is placed in the inferior vena cava IVC (which is a large blood vessel), a significant volume of blood flowing through the vein is diverted into the valve 29 by the coating / material. The coating / material can be fluid impermeable or can become fluid impermeable (e.g., via tissue ingrowth) so that blood cannot pass through. Again, a variety of other biocompatible coating materials can be used, such as any of the materials described elsewhere herein, including, for example, foams or fabrics that have been treated with a coating that is impermeable to blood, polyester, or engineered biological materials, such as pericardium, etc. More or all of the docking station frame 350 can be provided with the coating / material, forming a relatively large impermeable portion.

[0148] FIG. 51 illustrates an exemplary embodiment of a docking station frame 350 constructed from a coil 5100 of material. The coil 5100 can take a wide variety of different forms, and FIG. 51 illustrates merely one of many potential configurations. In the example of FIG. 51, the retaining portion 314 includes two relatively larger diameter coil segments 5110 and a smaller diameter segment 5112 that forms the valve seat 18. However, in other exemplary embodiments, only a single larger diameter coil segment 5110 may be included. A transition coil segment 5114 joins the smaller diameter segment 5112 to the larger diameter segment 5110.

[0149] A covering / material (not shown), such as one of the coverings / materials described elsewhere herein, a cloth, fabric, or protective foam, may be provided on the inside or outside of the coil to provide a sealing portion to the coil 5100 and create a sealing docking station. Such a covering / material may be connected to the coil or may be placed separately from the coil 5100 (e.g., placed either before or after placement of the coil 5100) and / or may be placed together with the transcatheter valve 29. The valve 29 is inflated and implanted within the smaller diameter segment 5112, which forms the valve seat 18.

[0150] The docking station coil 5100 is made of a highly elastic or flexible material and can accommodate large variations in anatomy. For example, the docking station coil 5100 can be made of a highly flexible metal, metal alloy, or polymer. An example of a highly elastic metal is Nitinol, but other metals and highly elastic or flexible non-metallic materials can also be used. The docking station 10 can be self-expandable, manually expandable (e.g., via a balloon), mechanically expandable, or a combination thereof. A self-expandable docking station 10 can be made of a shape memory material, such as, for example, Nitinol.

[0151] FIG. 52 illustrates the docking station coil 5100 of FIG. 51 implanted in the circulatory system, for example, in the inferior vena cava IVC. In the example of FIG. 52, the coil is held in place in the inferior vena cava IVC by a lower larger diameter segment 5110. The upper larger diameter segment 5110 is disposed in the right atrium RA. The larger diameter segment 5110 can expand to a larger size in the right atrium as shown, and the larger diameter segment can expand to the same size, or the larger diameter segment in the IVC can expand to a larger size than the larger diameter segment in the right atrium RA. The sealing portion 310 can be formed by providing a coating / material 21 (which can be the same or similar to other coatings / materials described herein) on or inside the frame 350 or a portion thereof. In an exemplary embodiment, the coating / material 21 covers one or both of the smaller diameter segment 5112 and the larger diameter segment 5110. This can make the docking station 10, including the coil 5100, impermeable or substantially impermeable from the sealing portion 310 to the seal between the valve 29 and the docking station 10 at the valve seat 18. As such, blood flowing in the inflow direction 12 toward the outflow direction 14 is directed toward the valve seat 18 (and the valve 29 when seated or disposed within the valve seat).

[0152] As one non-limiting example, when the docking station 10 is placed in the inferior vena cava IVC (which is a large blood vessel), a significant volume of blood flowing through the vein is diverted into the valve 29 by the covering or inner layer. The covering can be fluid impermeable or can be substantially impermeable, such that blood or most blood cannot pass through. Again, a variety of other biocompatible covering materials can be used, such as any of the materials described elsewhere herein, including, for example, foams or fabrics that have been treated with a coating that is impermeable to blood, polyester, or engineered biological materials, such as pericardium, etc. More or all of the docking station frame 350 can be provided with a covering / material (e.g., an impermeable covering / material) forming a relatively large impermeable portion.

[0153] 53 and 54 illustrate an exemplary embodiment of the docking station 10. The frame 350 or body can take a wide variety of different forms, and FIG. 53 illustrates just one of many potential configurations. The relatively narrower / smaller diameter portion 5316 forms the seat 18. The relatively narrow portion 5316 can take a wide variety of different forms. For example, the narrow portion 5316 can be any of the valve seat 18 disclosed herein, a ring, any conventional stent or frame, etc. In one exemplary embodiment, the inner end 5380 itself acts as the valve seat 18. In one exemplary embodiment, the narrow portion 5316 is replaced with a valve / THV 29, for example, a valve is integrated with the docking station structure such that the entire assembly acts as a transcatheter valve and can be implanted as one in the same implantation step.

[0154] 53 and 54, spaced apart radially outwardly extending arms 5318 disposed around the periphery of narrow portion 5316 form retaining portion 314. In the example of FIG. 53, inner ends 5380 of arms 5318 are connected to one another, positioned adjacent to one another, or spaced apart but positioned near one another. The example illustrated by FIG. 54 is substantially similar to the example of FIG. 53, except that inner ends 5380 of arms 5318 are connected to ends 5381 of narrow portion 5316. Docking stations can include various combinations and arrangements of arms 5318 and can include 2-32 arms (e.g., 2-16 arms) or more arms.

[0155] The radially outwardly extending arms 5318 can take a wide variety of different forms. In the illustrated example, the arms 5318 include an upper arm 5328 and a lower arm 5338. The docking station can include 1-16 upper arms 5328 (e.g., 1-8 upper arms) or more upper arms 5328, which can be uniformly or non-uniformly spaced apart radially, and can include 1-10 lower arms 5338 (e.g., 1-8 lower arms) or more lower arms 5338, which can be uniformly or non-uniformly spaced apart radially. In one exemplary embodiment, the upper arm 5328 is coupled to the lower arm 5338 and / or the inner portion 5316 such that the upper arm 5328 and the lower arm 5338 are relatively movable toward and away from each other.

[0156] 55A-55C, moving the upper and lower arms 5328, 5338 relative to one another toward and away from one another increases and decreases the diameter D or width of the docking station 10. For example, FIG. 55B can correspond to a nominal position, such as an average size of the implantation site (e.g., blood vessel, annulus, etc.) in which the docking station will be placed. However, any size may be selected. FIG. 55A illustrates that moving 5592 the arms 5328, 5338 relative to one another increases 5593 the diameter D or width of the docking station. That is, the arms 5328 extend more in the radial direction 5593 and less in the axial direction 5592 (compared to FIG. 55B), increasing the width or diameter D. Figure 55C illustrates that moving 5594 the arms 5328, 5338 relatively away from one another reduces the diameter D or width of the docking station 10 (compared to Figure 55B) - that is, the arms 5328, 5338 extend less in the radial direction 5595 and more in the axial direction 5594, decreasing the width or diameter D of the docking station.

[0157] The arms 5328, 5338 may be moved relatively toward and away from one another in a variety of different ways. For example, the arms 5328, 5338 may be made from a shape memory alloy with a shape set at the closest spacing (i.e., maximum diameter) between the arms 5328 and 5338. Alternatively, a spring may be provided between the arms 5328 and 5338 to bias the arms to the desired spacing. When the arms 5328, 5338 are biased to the maximum diameter, the docking station 10 will deploy until the arms engage the inner surface 416 (e.g., a vascular wall, an IVC wall, an SVC wall, an aortic wall, a native heart valve annulus, tissue surrounding a native heart valve annulus, a valve leaflet, etc.) with sufficient force to stop the arms from expanding and hold the docking station firmly in place.

[0158] In one exemplary embodiment, the distance between the arms 5328, and therefore the diameter D or width, can be manually adjusted. The distance between the arms 5328, and therefore the diameter D or width, can be manually adjusted in a variety of different ways. For example, the arms 5328, 5338 can be biased to a first position and an adjustment cord, line, or wire 5370 is coupled to the arms 5328, 5338 to move the arms from the first position. The arms 5328, 5338 can be biased to the first position in a variety of different ways. For example, the arms 5328, 5338 can be made from a shape memory alloy having a shape set, or the arms can be coupled by a spring or the like. The shape set or spring or the like may be set to provide as much spacing as possible between the arms 5328 and the corresponding arms 5338, such as, for example, a 180 degree angle defined therebetween or an approximately 180 degree angle (e.g., ±10 degrees, ±5 degrees) (i.e., extending directly apart in an axial direction). When the arms 5328 and 5338 are biased too far apart, the docking station 10 may be initially placed in a very narrow configuration. In the narrow configuration, the docking station 10 may be moved to the selected final placement site and checked for proper positioning. Once properly positioned, the diameter D or width may be adjusted by the adjustment cord, line, or wire 5370. For example, the cord, line or wire 5370 can be pulled to reduce the spacing between the arms 5328 and 5338, thereby increasing the diameter D or width of the docking station 10 and the strength of engagement with the inner surface 416 (e.g., a blood vessel wall, an IVC wall, an SVC wall, an aortic wall, a native heart valve annulus, tissue surrounding a native heart valve annulus, a valve leaflet, etc.) Once the docking station 10 is properly and securely engaged with the inner surface 416, the position of the arms 5328, 5338 can be fixed to secure the docking station in place.In some embodiments, the shape sets or springs or the like may be set to provide as little spacing as possible between arms 5328 and corresponding arms 5338, such as, for example, touching each other or with 5 degrees, 10 degrees, 20 degrees, 30 degrees, or less defined between them (i.e., the arms all extend radially or generally radially).

[0159] In another exemplary embodiment, the distance between the arms 5328, and thus the diameter D or width, can be manually adjusted to both increase the diameter D or width and decrease the diameter or width. For example, an adjustment cord, line, or wire 5370 is connected to the arms 5328, 5338 such that the arms can be moved both toward and away from each other. The spacing between the arms 5328 and 5338 can be as large as possible during initial placement, such as a 180 degree angle defined therebetween or approximately a 180 degree angle (i.e., extending directly away in an axial direction). In the narrow configuration, the docking station 10 can be moved to the selected final placement site and the proper positioning can be checked. Once properly positioned, the diameter D or width can be adjusted by the adjustment cord, line, or wire 5370. For example, the cord, line or wire 5370 can be pulled to reduce the spacing between the arms 5328 and 5338, thereby increasing the diameter D or width of the docking station 10 and the strength of engagement with the inner surface 416 (e.g., a blood vessel wall, an IVC wall, an SVC wall, an aortic wall, a native heart valve annulus, tissue surrounding a native heart valve annulus, a valve leaflet, etc.) Once the docking station 10 is properly and securely engaged with the inner surface 416, the position of the arms 5328, 5338 can be fixed to secure the docking station in place.

[0160] In the example of Fig. 53 and Fig. 54, the sealing portion 310 includes a covering / material 21 (which can be the same or similar to other coverings / materials described elsewhere herein) provided on the arm 5328, the arm 5338, or both sets of arms 5328, 5338, such as a cloth or fabric or a protective foam. The covering / material (e.g., an impermeable material or a semi-permeable material) can extend from the inner end 5380 and the valve seat 18 to the outer end 5390 of the arms 5328 and / or 5338 to form the sealing portion 310 of the docking station 10. The valve 29 can expand and be implanted in the narrow portion 5316, which forms the valve seat 18. It should be understood that the covering / material can extend three-dimensionally and generate a sealing region circumferentially around the valve 29 when placed in the circulatory system. For example, the coating / material can have a conical shape, a frusto-conical shape, a funnel shape, other shapes, etc., which can guide blood flow to the valve 29 and can reduce or prevent paravalvular leakage.

[0161] The docking station 10 illustrated by Figs. 53 and 54 can be made from highly elastic or flexible materials to accommodate large variations in anatomy. For example, the docking station can be made from highly flexible metals, metal alloys, polymers, or open cell foams. An example of a highly elastic metal is Nitinol, but other metals and highly elastic or flexible non-metallic materials can also be used. The docking station 10 can be self-expandable, manually expandable, mechanically expandable, or a combination thereof. A self-expandable docking station 10 can be made from a shape memory material, such as Nitinol, for example.

[0162] FIG. 56 illustrates the docking station 10 of FIG. 53 or FIG. 54 implanted in the circulatory system, for example, in the inferior vena cava. In FIG. 56, the entire docking station is held in place in the inferior vena cava by arms 5328, 5338. The coating / material 21 of the sealing portion 310 can make the docking station 10 impermeable or substantially impermeable from the sealing portion 310 to the seal between the valve 29 at the valve seat 18 and the docking station 10. As such, blood flowing in the inflow direction 12 toward the outflow direction 14 flows through the valve seat 18 (and the valve 29 when seated or placed in the valve seat).

[0163] As one non-limiting example, when the docking station 10 is placed in the inferior vena cava IVC (which is a large blood vessel), a significant volume of blood flowing through the vein is diverted into the valve 29 by the covering or inner layer. The covering can be fluid impermeable or can be substantially impermeable so that blood cannot pass through. Again, a variety of other biocompatible covering materials can be used, such as any of the materials described elsewhere herein, including, for example, foams or fabrics that have been treated with a coating that is impermeable to blood, polyester, or engineered biological materials, such as pericardium, etc.

[0164] In some exemplary embodiments, the walls 368 of the docking station frame 350 can have a non-circular shape or a non-circular radial cross-section. A wide variety of different non-circular shapes can be implemented. FIG. 57 illustrates one example of a docking station 10 having a frame 350 with a non-circular shape or a non-circular radial cross-section. In this example, the inflatable docking station 10 includes one or more sealing portions 310, a valve seat 18, and one or more retaining portions 314. In an alternative embodiment, the docking station 10 and the valve 29 can be integrally formed such that the combination forms a transcatheter valve that can be implanted as one in the same implantation step.

[0165] In the example of FIG. 57, the non-circular shape of the frame 350 allows an axially extending frame with a constant shape or cross-section along its length (prior to engagement by the inner surface 416) to both engage the inner surface 416 of the circulatory system and provide a seat 18 for the valve 29. The frame 350 with a constant axial shape can be configured to provide a valve seat 18 and an outer engagement surface 5710 in a wide variety of different ways. In the example of FIG. 57, the frame 350 has a contoured periphery 5712 with alternating inner and outer portions 5714 and 5716. The frame 350 can be comprised only of the wall 368 with the contoured configuration. However, the frame 350 can have additional structure, such as bands or other reinforcements to constrain the size of the valve seat 18.

[0166] The inner and outer portions 5714, 5716 can have a wide variety of different shapes, and there can be any number of inner and outer portions 5714, 5716. For example, the inner and outer portions 5714, 5716 can be formed by any series of lines and / or curves. In the illustrated embodiment, the frame 350 has four outer portions 5714 and four inner portions 5716, but the frame can have any number of inner and outer portions. For example, the frame 350 can have any number of inner and outer portions 5714, 5716 ranging from 3 to 100.

[0167] In the example of FIG. 57, the inner portion 5714 includes a concave curve and the outer portion 5716 includes a convex curve. The concave and convex curves are connected together to form a petal shape. However, the inner portion 5714 and the outer portion can have any shape. For example, increasing the number of inner portions 5714 and outer portions 5716 increases the number of points of contact between the frame 350 and the inner surface 416 of the circulatory system and the number of points of contact between the frame 350 and the valve 29.

[0168] The expandable frame 350 can take a wide variety of different forms. In the illustrated example, the expandable frame 350 is an expandable lattice. The expandable lattice can be made from individual wires or can be cut from a sheet and then rolled or otherwise formed into the shape of the expandable frame. The frame 350 can be made from highly flexible metals, metal alloys, or polymers. Examples of metals and metal alloys that can be used include, but are not limited to, Nitinol and other shape memory alloys, Elgiloy, and stainless steel, although other metals and highly elastic or flexible non-metallic materials can also be used to make the frame 350. These materials can allow the frame to be compressed to a small size, and then when the compressive force is released, the frame will self-expand back to its pre-compressed diameter and / or the frame can be expanded by the expansion of a device positioned inside the frame.

[0169] The sealing portion 310 of the docking station 10 illustrated by FIG. 57 can take a wide variety of different forms. A coating / material (which can be the same or similar to other coatings / materials described elsewhere herein) can be attached to a portion of the frame 350 to form the sealing portion 310. For example, the coating / material can cover the end 362 as shown. In one embodiment, the coating / material can cover (e.g., extend over or fill) the gap or a portion of the gap between the inner portion 5714 and the outer portion 5716. Optionally, the coating / material can extend along the frame wall 368. A portion of the frame wall 368 or the entire frame wall can be covered by the coating / material. However, the sealing portion 310 can also be formed in a wide variety of other ways.

[0170] In the example of FIG. 57, the retaining portion 314 includes a wall 368 of the frame 350. The shape set of the wall 368 biases the outer portion 5716 radially outward into contact with the inner surface 416 of the circulatory system (see FIG. 2) to hold the docking station 10 and valve 29 in the implanted position. In the illustrated embodiment, the retaining portion 314 is elongated to allow a small force to be applied to a large area of ​​the inner surface 416, which can allow the docking station to be held securely in place without exerting too much radial force on or damaging the inner surface 416. For example, the length of the retaining portion 314 can be 2, 3, 4, 5, or more than 5 times the outer diameter of the transcatheter valve.

[0171] Fig. 58 illustrates the docking station 10 of Fig. 58 implanted within the circulatory system, such as, for example, within the inferior vena cava IVC. In the example of Fig. 58, the entire docking station is positioned within the inferior vena cava IVC and is held in place by the frame 350 pressing against the inner surface 416. As noted above, the docking station 10 can be adapted for use in a variety of different locations within the circulatory system.

[0172] 59A and 59B illustrate an exemplary embodiment of a docking station frame 350 constructed from one or more coils 5900 of material formed into one or more rings 5902. The coils 5900 can take a wide variety of different forms, and FIGS. 59A and 59B illustrate merely one of many potential configurations. In the example of FIGS. 59A and 59B, the coils 5900 are rotated 90 degrees compared to the coils 5100 illustrated by FIG. 51 and formed into a ring shape, whereas the coils 5100 are not. The rings 5902 can be formed by bending one or more wires into a coiled configuration and then wrapping or bending the coils around the axis A of the docking station frame 350. The docking station can be transitioned between a collapsed configuration (e.g., for easier, lower profile delivery to the implantation site) and an expanded configuration (e.g., to secure the docking station in the implantation site and allow a transcatheter valve to be placed therein). FIG. 59A shows the docking station transitioning from the collapsed configuration to the expanded configuration. FIG. 59B shows the docking station in the expanded configuration. An interior surface of the coil 5900 can act as a valve seat for receiving a transcatheter valve. The docking station and coil 5900 can be formed from any of the materials described elsewhere herein as being used to form the other frame body portions 350, including Nitinol or another shape memory material.

[0173] The coil 5900 may be used to form the docking station 10 in a variety of different ways. The valve seat 18 may be formed inside or attached to the coil 5900 as illustrated by FIG. 59A and FIG. 59B. Referring to FIG. 59C, in another exemplary embodiment, the docking station 10 is formed from three coils 5900 or coil portions. The coils 5900 may be integrally formed, for example, from a single wire, or three separate coils 5900 may be connected or linked together to form the docking station 10. In the example of FIG. 59C, the docking station 10 includes two relatively larger diameter coil rings 5910 and a smaller diameter coil ring 5912, with the smaller diameter coil ring 5912 forming the valve seat 18. However, in some embodiments, only a single larger diameter coil ring 5910 is included.

[0174] A covering / material 21 (see, e.g., FIG. 59D), such as a cloth or fabric or a protective foam, may be provided on the inside and / or outside of the coil 5900 (e.g., the coils shown in any of FIGS. 59A-59D) or portions of the coil to provide a sealing portion for the coil 5900 and / or one or more coil rings 5902, 5910, 5912 and create a sealed docking station. Such covering / material may be connected to one or more of the rings 5902, 5910, 5912 or may be placed separately from the coil rings (e.g., placed either before or after placement of the coil 5900) and / or may be placed along with the valve / THV 29. The valve 29 (not shown in FIGS. 59A-59D) can be expanded in the center of the coil 5900 in FIGS. 59A-59B, or can be expanded within the smaller coil ring 5912 in FIGS. 59C-59D, which forms the valve seat 18.

[0175] The docking station coil 5900 and coil rings 5902, 5910, 5912 may be made from a highly elastic or flexible material to accommodate large variations in anatomy, or may be made from any of the materials described elsewhere herein with respect to the various frame body portions 350. For example, the docking station coil 5900 and coil rings 5902, 5910, 5912 may be made from a highly flexible metal, metal alloy, or polymer. An example of a highly elastic metal is Nitinol, but other metals and highly elastic or flexible non-metallic materials may also be used. The docking station 10 may be self-expandable, manually expandable (e.g., via a balloon), mechanically expandable, or a combination thereof.

[0176] FIG. 59D illustrates the docking station 10 of FIG. 59C implanted in the circulatory system, for example, in the inferior vena cava IVC. In the example of FIG. 59D, the docking station 10 is held in place in the inferior vena cava IVC by a lower, larger diameter ring 5910. The upper, larger diameter segment 5910 is disposed in the right atrium RA. The larger diameter ring 5910 can expand to a larger size in the right atrium than the ring in the IVC, as shown, and the larger diameter rings in the atrium and IVC can expand to the same size, or the larger diameter ring in the IVC can expand to a larger size than the larger diameter ring in the right atrium RA. The sealing portion 310 can be formed by providing a coating / material 21 on or inside the coil 5900 and one or more of the coil rings 5902, 5910, 5912 or portions thereof. In one embodiment, the coating / material 21 covers one or both of the smaller diameter ring 5912 and the larger diameter ring 5910. This can make the docking station 10 impermeable or substantially impermeable from the sealing portion 310 to the seal between the valve 29 and the docking station 10 at the valve seat 18. As such, blood flowing in the inflow direction 12 towards the outflow direction 14 is directed towards the valve seat 18 (and the valve 29 when seated or placed in the valve seat).

[0177] 60A-60J illustrate an exemplary embodiment, which is similar to the embodiment illustrated by FIGS. 3A-3C, except that the free ends of the frame 350 are connected together and / or extend closer together. For example, the end 6000 of the valve seat 18 or inner ring is connected to and / or extends to the end 6002 of the frame 350 / outer wall 368. The end 6000 of the valve seat 18 or inner ring may be connected to and / or extends to the end 6002 of the frame 350 / outer wall 368 in a wide variety of different ways. 60A-60J illustrate some of the possible ways in which the end 6000 of the valve seat 18 or inner ring may be connected to and / or extend to or toward the end 6002 of the frame 350.

[0178] Connecting or extending the end 6000 of the valve seat 18 or inner ring to the end 6002 of the frame 350 can provide several advantages. For example, the docking station 10 can be more easily loaded into a delivery catheter / sheath, and the docking station 10 can be more easily recaptured or pulled back into the catheter / sheath if the initial installation of the docking station is incorrect, incomplete, or if the medical professional wishes to abort or start over the procedure for any reason. Connecting the bottom / proximal end 6000 of the valve seat 18 to the end 6002 of the frame can help urge the end 6000 of the valve seat 18 radially inward and into the catheter / sheath. For example, as can be seen in Figures 21A-21H, the bottom / proximal end of the valve seat 18 (identified in these figures as end 2122) tends to extend outward even after the outer wall 368 begins to compress radially inward. During recapture, the end 6002 and / or proximal portion of the frame may be initially captured and / or retracted further into the delivery catheter / sheath, and by having the bottom / proximal of the valve seat 18 remain connected to the end 6002 of the frame, the retraction and compression of the end 6002 and the connection and / or portion of the frame proximal to the valve seat 18 can help urge the bottom / proximal end of the valve seat 18 radially inward and into the delivery catheter / sheath. This can also beneficially result in a more gradual compression of the valve seat 18. Even if the ends are not connected, but rather end 6000 simply extends proximate to end 6002 (e.g., such that the valve seat or inner ring or extension therefrom has a similar length as outer wall 368), this can be useful for loading, recapture, etc.For example, a longer end or extension from the valve seat can remain within the catheter / sheath during partial deployment and can allow for smoother recapture of a partially deployed docking station, and a longer end / extension can help provide a more gradual and controlled transition into the catheter / sheath.

[0179] Similarly, the valve seat 18 or ring of the docking station 10 may be compressed more evenly during the crimping process. For example, compression of the outer wall 368 before it contacts the valve seat 18 may assist or cause compression of both the proximal and distal ends of the valve seat 18 or inner ring.

[0180] Another advantage of connecting the free ends of the frame 350 together or connecting the ends 6000 and 6002 (and / or extending the free ends closer together) is that it can improve and make the placement of the docking station more controlled. If not connected (or if the unconnected ends are not similarly positioned / extended or of similar length), the docking station may tend to pop or move unpredictably out of the delivery catheter / sheath when the free end of the valve seat (e.g., end 2122 shown in Figures 21A-21H) is released from the delivery catheter / sheath. When no longer constrained by the delivery catheter / sheath, the free end (e.g., end 2122) can suddenly expand, causing the docking station to pop or move. By connecting the free ends of the docking station frame together or by connecting end 6000 and end 6002 (and / or by extending the end of the valve seat closer to the end of the outer wall), the expansion of end 6000 can be more contained and controlled when it is released from the delivery catheter / sheath, making the docking station placement more controlled and less likely to pop out or move or to move to such an extent, i.e., it is possible to prevent or contain / restrain popping out or uncontrolled movement of the docking station.

[0181] In the example of FIG. 60A (side cross-sectional view) and FIG. 60B (top end view), an end 6000 of the valve seat 18 or inner ring is connected to an end 6002 of the frame 350 by one or more lines 6010. The lines 6010 can take a wide variety of different forms. For example, the lines 6010 can be sutures, wires, rods, arms, struts, or any other elongated member, and can be rigid, semi-rigid, or flexible. In one embodiment, instead of lines, a coating / material (e.g., similar to the coating / material 21 described elsewhere herein) extends from the end 6000 to the end 6002 (e.g., in a conical or frusto-conical shape).

[0182] In the example of FIG. 60C (side cross-sectional view) and FIG. 60D (top end view), the end 6000 of the valve seat 18 or inner ring includes an integral extension 6020 that extends to the end 6002 of the frame 350. In the illustrated embodiment, the extension 6020 is connected to the end 6002 of the frame 350. In another exemplary embodiment, the extension 6020 is in substantially the same position as illustrated by FIG. 60C, but the extension 6020 is not connected to the frame. The extension can take a wide variety of different forms. In one exemplary embodiment, the bottom row of cells of the valve seat 18 or inner ring is elongated and extends (e.g., has an extending apex) to the end 6002 of the frame 350. In one exemplary embodiment, the lattice of struts and cells that form the frame body can continue to form the extension 6020.

[0183] In the example of FIG. 60E (side cross-sectional view) and FIG. 60F (top end view), the end 6000 of the valve seat 18 or inner ring includes an integral extension 6030 that, when inflated and extended to a location / length similar to the outer wall 368, is substantially parallel in cross section to the outer wall 368. In the example of FIG. 60E and FIG. 60F, the extension 6030 is not connected to the end 6002 of the frame 350. In the example of FIG. 60G (side cross-sectional view) and FIG. 60H (top end view), the extension 6030 is in substantially the same position as in FIG. 60E, but the extension 6030 is connected to the frame by a connecting portion 6040. The extension 6030 can take a wide variety of different forms. In one exemplary embodiment, the bottom row of cells of the valve seat 18 or inner ring is elongated and extended (e.g., has an extended apex) as shown. The optional connecting portion 6040 can take a wide variety of different forms. For example, the connecting portion 6040 can include one or more lines, such as wires, sutures, rods, arms, struts, and / or coverings / materials 21, etc.

[0184] In the examples of Figure 60I (side cross-sectional view) and Figure 60J (top end view), the frame 350 and seat 18 are integrally formed and may have a toroidal shape. Referring to Figure 60I, in cross-section, the frame 350 and valve seat 18 form one or more loops 6050. In one exemplary embodiment, the loops 6050 are formed from a continuous lattice of struts and cells. However, the loops may be formed in a wide variety of different manners.

[0185] In the various figures herein, a "V" or generic valve symbol is used to generally represent various valves that may have different structures for opening and closing the valve and may operate in different ways. FIGS. 61-65 illustrate some examples of many valves or valve configurations that may be used. Any valve type may be used, and some valves that are traditionally surgically applied may be modified for transcatheter implantation. The transcatheter valve may be inflated in various ways, for example, it may be self-inflating, balloon inflatable, mechanically inflatable, and / or a combination thereof. In one example, a mechanical opening mechanism, such as a hinged mechanism, may be used to inflate the transcatheter valve, and / or the frame of the transcatheter valve may include a hinged mechanism. FIG. 61 illustrates an inflatable valve 29 for transcatheter implantation as shown and described in U.S. Pat. No. 8,002,825, which is incorporated herein by reference in its entirety. An example of a tri-cusp valve is shown and described in published WO 2000 / 42950, ​​which is incorporated herein by reference in its entirety. Another example of a tri-cusp valve is shown and described in U.S. Pat. No. 5,928,281, which is incorporated herein by reference in its entirety. Another example of a tri-cusp valve is shown and described in U.S. Pat. No. 6,558,418, which is incorporated herein by reference in its entirety. FIGS. 62-64 illustrate an exemplary embodiment of an inflatable tri-cusp valve 29, such as the Edwards SAPIEN Transcatheter Heart Valve. The valve 29 can include a frame 712 that contains a tri-cusp valve 4500 compressed inside the frame 712. FIG. 63 illustrates the frame 712 inflated and the valve 29 open. FIG. 64 illustrates the frame 712 inflated and the valve 29 closed.65A, 65B, and 65C illustrate an example of an inflatable valve 29, which is shown and described in U.S. Pat. No. 6,540,782, which is incorporated herein by reference in its entirety. Another example of a valve is shown and described in U.S. Pat. No. 3,365,728, which is incorporated herein by reference in its entirety. Another example of a valve is shown and described in U.S. Pat. No. 3,824,629, which is incorporated herein by reference in its entirety. Another example of a valve is shown and described in U.S. Pat. No. 5,814,099, which is incorporated herein by reference in its entirety. Any of these, the valves described in the incorporated references, or other valves may be used as valve 29 in various embodiments herein.

[0186] The docking stations described above can be used to form a docking station assembly, including, for example, a graft or other elements. For example, the docking station assembly can include a graft and a docking station. The graft can be shaped to match a portion of an internal shape of a first portion of a circulatory system (e.g., a blood vessel, vasculature, a native heart valve, etc.). The docking station and the graft can be coupled to each other. The various docking stations described herein can be used in an assembly, which can include an expandable frame, at least one sealing portion, and a valve seat, as discussed above. The expandable frame can be configured to match an internal shape of a second portion of the circulatory system (e.g., a blood vessel, vasculature, a native heart valve, etc.) when expanded inside the circulatory system. The sealing portion can be configured to contact an internal surface of the circulatory system. The valve seat can be connected to the expandable frame. The valve seat can be configured to support an expandable transcatheter valve. The docking station may be integrally formed with the valve, for example, such that the combination of the docking station and valve is a prosthetic valve or a transcatheter prosthetic valve that can be implanted in the same step. The frame may be formed and configured in any of the manners described in this disclosure, for example, the frame may be made from Nitinol, Elgiloy, or stainless steel. A portion of the docking station may engage the interior of the graft. The graft may be shaped or configured to fit the interior surface of the circulatory system.

[0187] 66A-72C, an exemplary docking station placement assembly / system 7000 for placing a docking station / device is shown. The various docking station placement assemblies / systems 7000 herein may be used with any of the docking stations / devices described or shown in this disclosure (e.g., those shown in Figures 2A-36, 42-60J), as may be modified accordingly. The docking placement assembly / system 7000 (e.g., docking station placement assembly, docking station placement system, docking device placement assembly, etc.) can include a catheter 2200, a docking station frame 350, and a pusher or other retention device 2300, where the catheter 2200 defines a lumen or delivery passageway 2202 with an inner surface 2203 and has a distal opening 2206 (and, optionally, a proximal opening 2204 as well), the docking station frame 350 can be radially compressed and expanded, and the pusher or other retention device 2300 has a distal end 2302 and an outer circumferential surface 2304. The docking placement assembly / system can also include a handle connected to a proximal end of the catheter 2200. The handle can include a control (e.g., a knob, button, switch, etc.) for adjusting the assembly / system.

[0188] The docking placement assembly / system herein may also include an inner shaft or inner catheter (or as an alternative to a pusher). The inner shaft / catheter may extend inside the catheter 2200, the docking station, and / or the pusher. The inner shaft / catheter may include a nosecone (e.g., a flexible nosecone) to aid in navigation to a target placement site in the body. The inner shaft / catheter may include a guidewire lumen so the docking placement assembly / system may be more easily advanced to a target placement site. The proximal end of the inner shaft / catheter may connect to a handle.

[0189] The pusher 2300 may be made of any semi-flexible or flexible material that can pass through or snake through the catheter 2200 (e.g., when the catheter is positioned in the body and when the catheter includes multiple turns in different directions along the anatomy) and exert a distal force at the distal end 2302 of the pusher 2300. The pusher 2300 may be hollow, a tube, a coil, and / or may be solid or have a solid cross-section. The pusher 2300 may have no lumens, or may have one or more lumens, etc. The frame 350 of the docking station 10 may be made from any combination of materials disclosed herein. For example, the docking station 10 and its components may be made from a shape memory alloy frame, foam, fabric covering, combinations thereof, etc. Also, the docking station frame 350 may take any shape, form, or configuration disclosed herein. The docking station frame 350 (when in a compressed state) and the pusher 2300 may be receivable within the lumen / delivery passageway 2202 of the catheter 2200, with the docking station frame 350 near the distal opening 2206 of the catheter 2200, and with the pusher 2300 proximal or relatively closer to the proximal end of the docking station. The distal end 2302 of the pusher 2300 may be disposed in abutting contact with or near the proximal end 315 of the docking station frame 350, and the distal end 317 of the docking station frame 350 may be disposed within the lumen / delivery passageway 2202 of the catheter 2200. At least a portion of the pusher 2300 may be sized to have a diameter at least as large as an inner diameter of the docking station frame 350 when in a compressed state.

[0190] 66A and 66B, the docking station frame 350 and pusher 2300 may be disposed within the catheter 2200 such that distal movement of the pusher 2300 (i.e., toward the distal opening 2206 of the catheter 2200) applies a distal force to the proximal end 315 of the docking station frame 350, causing the proximal end 315 of the frame 350 to move toward the distal opening 2206 of the catheter 2200. As shown in FIG. 66A, as the docking station frame 350 is moved distally through the lumen / delivery passageway 2202 (or as the catheter 2200 is retracted proximally over the frame 350), the distal end 317 of the frame 350 moves distally past the distal opening 2206 of the catheter 2200, causing the distal portion of the frame 350 that is outside of the catheter 2200 to begin to expand radially outward. The portion of the frame 350 outside the catheter 2200 will expand radially outward to a diameter greater than the diameter of the catheter 2200, and the portion of the frame 350 within the catheter 2200 will remain compressed. As shown in FIG. 66B, when the pusher 2300 pushes the frame 350 distally through the distal opening 2206 of the catheter 2200 (or the distal opening 2206 of the catheter 2200 is retracted proximally past the frame 350), the frame 350 will pass distally through the distal opening 2206 of the catheter 2200 and will be fully radially expanded at the desired location.

[0191] Optionally, instead of axially advancing / advancing the pusher 2300 through the catheter 2200 to push the docking station / device out of the catheter 2200, the pusher 2300 may be configured as (or replaced by) an inner shaft or inner catheter that remains stationary (e.g., relative to the handle). The inner shaft / catheter may include or be attached to a retention device to hold the docking station / device until a desired time (e.g., until full deployment). Instead of the pusher being advanced through the catheter 2200, the catheter 2200 (e.g., retention sheath, delivery capsule, outer sheath, etc.) may be retracted to release and deploy the docking station / device. This type of deployment assembly / system may be otherwise similar to those discussed elsewhere herein and may include features and / or components of other deployment assemblies / systems herein (e.g., those shown in FIGS. 66A-72C).

[0192] 12 and 67-72C, the pusher or retention device 2300 and / or the docking station frame 350 of the docking placement assembly / system 7000 may be sized, shaped, tethered, or otherwise designed such that the positioning of the frame 350 is maintained or otherwise controlled while placing the frame 350 until the frame 350 is fully released from the catheter 2200. In one embodiment, the frame 350 is held by or otherwise connected to the catheter 2200, the pusher 2300, the inner shaft / catheter, and / or the retention device, even after the frame 350 is fully radially expanded. The frame 350 may then be released from the catheter 2200, the pusher 2300, the inner shaft / catheter, and / or the retention device once the docking station frame 350 is fully radially expanded. The position of the frame 350 may be maintained in a variety of ways.

[0193] 12 and 68A, the docking station frame 350 can include at least one leg or extension 319, or multiple legs / extensions 319. The legs / extensions 319 can be proximal legs / extensions extending from a proximal end of the frame 350. Each proximal leg / extension 319 can be a rod that extends proximally (e.g., toward the pusher 2300 or retention device when the frame 350 is disposed within the catheter 2200) beyond other parts of the docking station frame 350 (e.g., beyond all other parts). In one embodiment, the multiple proximal legs / extensions 319 are evenly spaced around the circumference of the frame 350 and extend proximally (e.g., longitudinally, axially, downwardly) from the proximal-most strut 1200. Each proximal leg / extension 319 can include an end shape or foot 321 at an end (e.g., proximal end) of the leg / extension 319. Each proximal shape / foot 321 can extend circumferentially, radially inward, and / or radially outward farther than the proximal leg / extension 319. In one embodiment, the proximal shape / foot 321 is substantially spherical or otherwise bulbous. However, it will be appreciated that the end shape or foot 321 can be of any shape or size that is receivable into a corresponding tab or slot in the pusher 2300 or other retention device, as described below. For example, the end shape / foot 321 can be rectangular, elongated, pyramidal, triangular, slotted, grooved, hollow, ring-shaped, or any other design known in the art.

[0194] Although the proximal leg / extension 319 has been described as being part of the frame 350 of Figure 12, it will be appreciated that the proximal leg / extension 319 may be incorporated into any of the docking station frames 350 disclosed herein. For example, the proximal leg / extension may be included at the proximal end of the docking station frame 350 of Figure 25 or 26, or any other frame 350 described herein.

[0195] 67, an exemplary distal end 2302 of a pusher 2300 or other retention device (e.g., when a pusher is not used) is shown. The illustrated pusher 2300 (or retention device) includes a plurality of slots or tabs 2306 in an outer circumferential surface 2304 of the pusher 2300 (or retention device) and disposed about the distal end 2302 of the pusher 2300 (or retention device). Each of the slots 2306 can be sized, shaped, or otherwise designed to retain the proximal leg / extension 319 and / or end shape / foot 321 of the frame 350 when the frame 350 and pusher 2300 (or retention device) are disposed within the catheter 2200. In one embodiment, the number, size, and shape of the slots 2306 correspond to the number, size, and shape of the proximal legs / extensions 319 and / or end features / feet 321 of the docking station frame 350 .

[0196] Prior to placement of the docking station and frame 350, the docking station and frame 350 may be inserted into the catheter 2200 with the end / foot 321 and proximal leg / extension 319 of the docking station or frame 350 disposed in the slot 2306 of the pusher 2300 or retention device. In one embodiment, the outer circumferential surface 2304, slot 2306, proximal leg / extension 319, and end / foot 321 of the pusher 2300 or other retention device are sized such that the proximal end / foot 321 may be retained in the slot 2306 and, when disposed in the catheter 2200, between the pusher 2300 or other retention device and the inner surface 2203 of the catheter 2200. In some embodiments, the pusher 2300 moves or is capable of moving distally out of the catheter 2200, pushing the docking station and its frame 350 distally out of the distal opening 2206. In some embodiments, the catheter 2200 (e.g., outer sheath, sleeve, delivery capsule, etc.) is retracted to expose and release the docking station and its frame 350. For a self-expandable frame, once the docking station or frame 350 is exposed (e.g., by retracting the catheter 2200 and / or by pushing it out of the catheter 2200), the exposed portion begins to expand radially.

[0197] While the slot 2306 is still in the catheter 2200, the proximal foot 321 will still be held in the catheter 2200, so that the position of the frame 350 may be maintained or otherwise controlled. As such, the frame 350 may expand substantially radially outward, with a portion of the frame 350 being maintained or otherwise controlled by the catheter 2200, the pusher 2300, the inner shaft / catheter, and / or a retention device. Once a substantial portion of the slot 2306 has been moved distally past the distal opening 2206 of the catheter 2200, the proximal foot 321 may be released from the slot 2306, and the positioning of the frame 350 may be set. The self-expansion of the frame 350 may cause the extensions / legs and ends / foots to move radially out of the slots when exposed.

[0198] Optionally, the pusher or other retention device may include or be configured as a lock and release connector similar to that shown and described in International Patent Application No. PCT / US2018 / 040337, filed June 29, 2018, and U.S. Provisional Patent Application No. 62 / 527,577, filed June 30, 2017, each of which is incorporated herein by reference in its entirety. The lock and release connector may include a body portion and a door (or, optionally, a plurality of doors) engaged with the body portion, at least one door (or each of the plurality of doors) being movable from a first position to a second position. The door may be integral with the body portion or may be connected to the body portion. The door may be constructed in a variety of ways and may include a variety of different materials. The lock and release connector may further include a fastener or fasteners connecting at least one portion or end of the door to the body.

[0199] The docking station / device and frame 350 may have one or more extensions / legs and may be disposed within the catheter 2200. If an inner shaft / catheter is used, the lock and release connector may be connected to the inner shaft / catheter. A slot 2306 may be formed between the body and the door. The extension / leg of the docking station and frame may be interposed between the body and the door (e.g., in the slot). Optionally, the lock and release connector may further include a second door, and the second extension / leg of the docking station and frame may be interposed between the body and the second door. The body may be hingedly connected to the door.

[0200] The catheter 2200 with the docking station therein may be positioned at the target delivery site. The catheter 2200 may be retracted or the frame may be pushed out of the catheter 2200 until the distal end of the docking station or frame is positioned outside of the catheter 2200. The catheter 2200 may be further displaced (e.g., pulled out, etc.) with respect to or relative to the docking station and lock and release connector until the door opens and releases the extension from between the body and the door. The door is biased (e.g., includes a spring, etc.) and may cause the door to open when the catheter 2200 is no longer covering it, helping to release the extension.

[0201] Referring to Figures 68A to 72C, three exemplary docking placement assemblies / systems 7000 are shown that allow a user to maintain or otherwise control the position of the frame 350 once the frame 350 is fully radially expanded outside the catheter 2200.

[0202] 68A-70, an exemplary docking station placement assembly 7000 is shown. A frame 350 includes at least one elongated leg / extension 323 disposed at a proximal end of the frame 350 and attached or otherwise secured to a proximal strut 1200. Each elongated leg / extension 323 can include a foot / end feature 325 at a proximal end of the elongated leg / extension 323. Each end / foot 325 can extend circumferentially, radially inwardly, and / or radially outwardly further than the elongated leg / extension 323. In one embodiment, the end / foot 325 is substantially spherical or otherwise bulbous. However, the end / foot 325 can be of any shape or size that is receivable into a corresponding tab or slot in the pusher 2300 or other retention device. For example, the end / foot 325 can be rectangular, elongated, slotted, grooved, hollow, ring-shaped, or any other design known in the art. The frame 350 can also include a proximal leg / extension 319 and an end shape / foot 321 as previously described. In one embodiment, an elongated leg / extension 323 is included on the frame 350 in place of one of the proximal legs / extensions 319, and the elongated leg / extension 323 extends longitudinally farther away from the remainder of the frame 350 than the proximal leg / extension 319. Although the illustrated embodiment shows the frame 350 as having only one elongated leg / extension 323, two or more elongated legs / extensions 323 may be included.

[0203] At least one elongated leg / extension 323 of the frame 350 can take a variety of forms. As shown in FIG. 69A and FIG. 69B, at least one elongated leg / extension 323 of the frame 350 can be flexible, such as a flexible rod (FIG. 69A), or can be rigid, such as a rigid rod (FIG. 69B). Including a flexible (e.g., spring-like, coiled, thinned, slotted, etc.) elongated leg / extension 323 can allow the frame 350 to extend smoothly out of the catheter 2200 because the frame 350 expands radially as the frame 350 is moved distally out of the catheter 2200. For example, after the proximal leg / extension 319 is released from the slot 2306, but while the end / foot 325 is still held within the elongated recess or slot 2308 in the catheter 2200, the flexible (e.g., spring-like, etc.) elongated leg / extension 323 can bend, expand, or otherwise adjust to accommodate (or a portion of) the radial expansion of the frame 350. The inclusion of a rigid (e.g., rod-like, etc.) elongated leg / extension 323 can allow the frame 350 to be positioned or otherwise moved as the frame expands radially when it is moved distally out of the catheter. For example, after the proximal leg / extension 319 is released from the slot 2306, but while the end / foot 325 is still retained in the slot 2308, the rigid elongated leg / extension 323 can hold the frame 350 securely to the pusher 2300, retention device, inner shaft / catheter, and / or catheter 2200 such that the frame 350 can be more easily positioned or otherwise moved after inflation.However, it will be appreciated that the elongate legs / extensions 323 can take other forms. For example, the elongate legs / extensions 323 can be curved, twisted, bent, or otherwise shaped according to the desired placement and / or control of the frame 350 out of the catheter 2200.

[0204] 70, the distal end 2302 of the pusher 2300 or other retention device can include at least one elongated slot 2308 in an outer circumferential surface 2304 of the pusher 2300 or other retention device. The at least one elongated slot 2308 can be sized and shaped to correspond to the size and shape of the elongated leg / extension 323 (or a portion thereof) and / or end / foot portion 325 of the frame 350. The pusher 2300 or other retention device can optionally include one or more additional slots 2306 (e.g., in the outer circumferential surface 2304 of the pusher 2300 or other retention device, between the body portion and the door / latch, etc.). The optional elongated slot(s) 2308 and the shorter slot(s) 2306 can extend (e.g., axially or parallel to a longitudinal axis) from the distal end 2302 of the pusher 2300 or other retention device toward the proximal end of the pusher 2300 or other retention device. In one embodiment, the slot(s) 2308 extend further proximally from the distal end 2302 of the pusher 2300 or other retention device than the optional slot(s) 2306.

[0205] Prior to placement of the frame 350, the frame 350 (and, optionally, the pusher) may be inserted into the catheter 2200 with the proximal end / foot 321 and proximal leg / extension 319 of the frame 350 oriented proximally. The end / foot 321 and / or proximal leg / extension 319 (e.g., a portion thereof) of the frame 350 may be disposed in a slot 2306 of the pusher or retention device 2300. The end / foot 321 may be retained in the slot 2306 (e.g., between the pusher or retention device 2300 and the inner surface 2203 of the catheter 2200, or between the body of the retention device and the door / latch) and one or more ends / feet 325 of one or more elongated legs / extensions 323 may be retained in the slot 2306 (e.g., between the pusher or retention device 2300 and the inner surface 2203 of the catheter 2200, or between the body of the retention device and the door / latch) when the pusher or retention device 2300 and one or more ends / feet are disposed in the catheter 2200. In one embodiment, outer circumferential surface 2304, slot 2306, slot 2308, proximal leg / extension 319, proximal end / foot portion 321, elongated leg / extension 323, and end / foot portion 325 of pusher or retention device 2300 are sized so that the pusher or retention device 2300 may be retained within 8 (e.g., between pusher or retention device 2300 and inner surface 2203 of catheter 2200, or between the body of the retention device and a door / latch).

[0206] As the docking station / device moves out of the catheter 2200, the frame 350 exits the distal opening 2206 and the frame 350 begins to expand. The position of the frame 350 can be maintained or otherwise controlled while at least one extension / leg (e.g., a portion thereof) and / or end / foot is still held within the catheter 2200 (e.g., within a retention device). As such, the frame 350 (e.g., stepwise, the distal end, then another distal portion of the frame, then a middle portion of the frame, then a proximal portion, and then substantially all of the frame) can expand substantially radially outward while a portion of the frame 350 (e.g., one or more extensions / legs, a portion thereof, and / or one or more foot / ends thereof) is maintained or otherwise controlled by the catheter 2200 and / or the pusher or retention device 2300.

[0207] In one embodiment, the retention device (e.g., a pusher) includes at least one elongated slot 2308 and at least one shorter slot 2106, and after all or most of the shorter slots 2306 are moved distally through the distal opening 2206 of the catheter 2200 (e.g., uncovered by retracting the catheter or advancing the shaft or pusher), one or more ends / foots 321 are released from the slots 2306 and the frame 350 fully radially expands (e.g., expands until it is in contact with the circulatory system). At least one end / foot 325 of at least one elongated leg / extension may still be retained within the elongated slot 2308 (e.g., all or a portion thereof) even after the shorter slots 2306 are moved distally through the distal opening 2206 of the catheter 2200. As such, the frame 350 is allowed to fully radially expand, and the position of the frame 350 may be maintained or otherwise controlled by retention of the elongated leg / extension 323 and / or end / foot 325 in the catheter 2200. Once all or most of the at least one elongated slot 2308 is exposed or has been moved distally past the distal opening 2206 of the catheter 2200 (e.g., exposed by retracting the catheter or advancing the shaft or pusher), the at least one end / foot 325 may be released from the at least one elongated slot 2308 and the positioning of the frame 350 may be set. If a door / latch is used over any of the slots, the door will open to allow the underlying end / foot to be released.

[0208] In one embodiment, the retention device (e.g., pusher) includes only one elongated slot 2308, and as the frame 350 is moved distally through the distal opening 2206 of the catheter 2200 (e.g., uncovered by retracting the catheter or advancing the shaft or pusher), the frame 350 expands incrementally from distal to proximal until it is fully radially expanded (e.g., expanded into contact with the circulatory system). Even after all but the end / foot 325 of the frame 350 has been moved distally through the distal opening 2206 of the catheter 2200, the end / foot 325 of the elongated leg / extension may still be retained within the elongated slot 2308 (e.g., all or a portion thereof). As such, the frame 350 may be allowed to fully radially expand, and the position of the frame 350 may be maintained or otherwise controlled by retention of the elongated leg / extensions 323 and / or ends / foots 325 in the catheter 2200. Once all or most of the elongated slots 2308 have moved distally past the distal opening 2206 of the catheter 2200 (e.g., having been uncovered by retracting the catheter or advancing the shaft or pusher), at least one end / foot 325 may be released from at least one elongated slot 2308, and the positioning of the frame 350 may be set. If a door / latch is used over the slot 2308, the door will open to allow the underlying end / foot 325 to be released.

[0209] Having only one extension / leg or only one elongated extension / leg 323 on the self-expandable frame acts to help prevent the frame from popping out of the distal end of the catheter and upsetting the placement. When the proximal end 315 of the frame 350 approaches the distal opening 2206 of the catheter, forces can build up between the proximal end 315 and the distal opening 2206, which can cause the frame to pop forward out of the catheter. Having multiple legs / extensions at the proximal-most end of the frame 350 can make popping out more likely because the legs / extensions can act against each other and create opposing forces against the distal end of the catheter. By having the proximal end 315 of the frame 350 have only one elongated extension / leg 323 (e.g., with or without the shorter extension / leg 319) or only one extension / leg (e.g., 319 or 323), the frame 350 can be allowed to fully expand while being held down by only one extension / leg, and then this one remaining extension / leg can release the frame 350 without causing popping out.

[0210] 71A-71C, an exemplary docking device placement assembly 7000 is shown. The docking device placement assembly 7000 can be similar to those described above and can alternatively or additionally include a suture or retaining line 2700 that can be used to maintain the position of the frame 350 as it is deployed from the catheter 2200 and fully radially expanded. The inner shaft, retention device, or pusher 2300 is shown as including two suture passages 2310 that extend longitudinally through the inner shaft, retention device, or pusher 2300 and each of the two suture passages 2310 can receive a portion or end of a suture 2700. However, only a single passage can be used. In one embodiment, the suture 2700 is threaded through one of the suture passages 2310, around a portion of the frame 350, and back through the other suture passage 2310 such that both ends of the suture 2700 extend through a proximal portion of the catheter 2200. The suture 2700 may be secured around any portion of the frame 350. In one embodiment, the suture 2700 is looped around one or more struts 1200 or the apexes of the struts of the frame 350. In another embodiment, the frame (e.g., the apexes of the frame) include one or more loops, apertures, holes, etc. through which the suture 2700 may be threaded.

[0211] In one embodiment, the pusher 2300 is used to apply a distal force to the frame 350, moving the frame 350 distally through the distal opening 2206 of the catheter 2200, while the suture 2700 applies a proximal force to the frame 350, maintaining the frame 350 in contact with and / or in proximity to the pusher 2300 (e.g., by holding the suture or by pulling the suture proximally). 71A, when the pusher 2300 pushes a portion of the frame 350 through the distal opening 2206 of the catheter 2200, the portion of the frame 350 extending beyond the distal opening 2206 will begin to expand radially outward and the proximal force applied by the sutures 2700 will keep the frame 350 (e.g., the proximal end of the frame 350) in contact with and / or in close proximity to the pusher 2300. In FIG. 71B, when the pusher 2300 pushes the frame 350 fully through the distal opening 2206, the frame 350 is allowed to fully expand radially and the proximal force applied to the frame 350 by the sutures 2700 will keep the frame 350 in close proximity to the distal end of the pusher 2300 and / or catheter 2200. In FIG. 71C, once the frame has been fully radially expanded in the desired position, the sutures 2700 may be removed from the suture channels 2310 and the frame 350 such that the expanded frame 350 remains in the desired position.

[0212] In one embodiment, the suture 2700 applies a proximal force to the frame 350 as the catheter 2200 (e.g., outer sheath, delivery capsule, sleeve, etc.) is withdrawn (e.g., by holding the suture or by pulling the suture proximally) to maintain the frame 350 in contact and / or in close proximity to the inner shaft, retention device, or pusher 2300. As shown in FIG. 71A, when the catheter is retracted such that a portion of the frame 350 is exposed, the portion of the frame 350 extending beyond the distal opening 2206 expands radially outward and the proximal force applied by the suture 2700 maintains the frame 350 (e.g., the proximal end of the frame 350) in contact and / or in close proximity to the inner shaft, retention device, or pusher 2300. As shown in Fig. 71B, once the catheter is fully retracted over the frame 350, the frame 350 will fully radially expand and the proximal force applied to the frame 350 by the sutures 2700 can maintain the frame 350 proximate to the inner shaft, retention device or pusher 2300, and / or the distal end of the catheter 2200. As shown in Fig. 71C, once the frame is fully radially expanded in the desired position, the sutures 2700 can be removed from the suture channels 2310 and frame 350 such that the expanded frame 350 remains in the desired position.

[0213] Although this exemplary docking station placement assembly 7000 has been described and shown as including only sutures 2700 (e.g., no extensions / legs are required) to maintain the position of the frame 350 after it is fully radially expanded, other features may be included to maintain the position of the frame 350 after it is fully radially expanded. For example, the frame 350 may include a proximal leg / extension 319 and a proximal end / foot portion 321, and / or one or more elongated leg / extensions 323 and one or more end / foot portions 325, and the pusher / inner shaft / retention device may include a shorter slot 2306 and / or one or more elongated slots 2308 to maintain the position of the frame 350 after it is fully radially expanded, as described above.

[0214] 72A-72C, an exemplary docking station placement assembly 7000 is shown. In the illustrated embodiment, the pusher / inner shaft / retention system 2300 includes a distal portion having a first outer circumferential surface 2312 and a proximal portion having a second outer circumferential surface 2314. The distal and proximal portions may be integrally formed or the distal portion 327 may be a separate component, such as a pin, attached to or extending through a lumen in the proximal portion. In one embodiment, a pin is used as the surface 2312 without any larger diameter proximal portion. The pin and / or distal portion may include a lumen through which another portion of the system and / or guidewire may pass. The distal end 2302 of the distal portion may optionally be tapered or otherwise rounded. The first outer circumferential surface 2312 of the pusher / retention system 2300 can be narrower or have a smaller diameter (or have the same or similar diameter) than the inner diameter of the frame 350 when the frame 350 is in a compressed state within the catheter 2200, and the second outer circumferential surface 2314 of the pusher / retention system 2300 can be wider or have a larger diameter than the inner diameter of the frame 350 when the frame 350 is in a compressed state and can be narrower or have a smaller diameter than the inner surface 2203 of the catheter 2200. For example, the frame 350 can be crimped around the outer circumferential surface 2312. In one embodiment, the first outer circumferential surface 2312 has a diameter large enough to hold a proximal portion of the frame 350 in abutting contact with the inner surface 2203 of the catheter 2200.

[0215] In use, when the pusher / inner shaft / retention system 2300 and frame 350 are disposed within the catheter 2200, a distal portion of the second outer circumferential surface 2314 of the pusher 2300 can abut the proximal end 315 of the frame 350 and a distal portion of the first circumferential surface 2312 (e.g., narrowed portion, pin, etc.) is disposed within the inner diameter of the compressed frame 350. Within the catheter 2200, the first circumferential surface 2312 and the inner surface 2203 can capture or restrain a portion of the frame 350 within the catheter 2200 between them. A user can use the pusher / retention system 2300 to apply a distal force to the frame 350 to move the frame 350 distally through the distal opening 2206 of the catheter 2200 and / or retract the catheter 2200 over the frame 350.

[0216] In one embodiment, as shown in FIG. 72A, the pusher / inner shaft / retention system 2300 may be used to push a portion of the frame 350 through the distal opening 2206 of the catheter 2200, and the portion of the frame 350 extending beyond the distal opening 2206 begins to expand radially outward. In one embodiment, also represented by FIG. 72A, the catheter 2200 may be retracted proximally from over the frame 350, and the portion of the frame 350 extending beyond the distal opening 2206 expands radially outward. As shown in FIG. 72B, to the extent that any portion of the frame 350 remains within the catheter 2200, the first circumferential surface 2312 and the inner surface 2203 of the pusher / inner shaft / retention system 2300 may capture, restrain, or pinch a portion of the frame (e.g., at least a proximal portion) that is within the catheter. This can help prevent or inhibit the expansion forces of the frame 350 from causing the frame 350 to pop out and / or exit the catheter 2200 before the transition or step between the outer circumferential surface 2314 and the inner circumferential surface 2312 reaches the end of the catheter 2200. As such, the frame 350 will be maintained in the proper position throughout its deployment from the catheter 2200. When the frame 350 is entirely outside the distal end of the catheter 2200, as shown in FIG. 72C, the frame 350 can be fully radially expanded and deployed at the desired target location. The pusher / inner shaft / retention system 2300 can be retracted from the frame 350 and pulled back into the catheter 2200 or re-covered by the catheter 2200.

[0217] In one embodiment, the docking station placement assembly 7000 includes only the pusher / inner shaft / retention system 2300 with the first and second circumferential surfaces to maintain the position of the frame 350 after the frame 350 is fully radially expanded. However, in some embodiments, other features are included to maintain the position of the frame 350 after the frame 350 is fully radially expanded. For example, the frame 350 can include a proximal leg / extension 319 and a proximal end / foot 321, and / or one or more elongated leg / extensions 323 and one or more end / foot portions 325, the pusher / retention system 2300 can include a shorter slot 2306 and / or one or more elongated slots 2308, and / or the docking station placement assembly 7000 can include sutures 2700 to maintain the position of the frame 350 after the frame 350 is fully radially expanded, as described above. In particular, if other retention features (e.g., extensions and slots, doors / latches, sutures, etc.) are used, the distal portion or pin (e.g., surface 2312) will need to capture the frame 350 and may have a smaller diameter than the inner surface of the frame.

[0218] The distal portion or pin with surface 2312 acts to help prevent the self-expandable frame from popping out of the distal end of the catheter and becoming dislodged. When the proximal end 315 of the frame 350 approaches the distal opening 2206 of the catheter, forces can build up between the proximal end 315 and the distal opening 2206, which can cause the frame to pop forward out of the catheter. These forces make popping more likely, which is especially true when the proximal end 315 of the frame is angled radially inward relative to the inner surface of the catheter 2200. For example, as more of the frame 350 expands outside of the catheter, the proximal end 315 that remains within the catheter tends to angle radially inward and can build pressure against the distal opening 2206, which can flip or bounce the frame 350 out of the catheter as the proximal end tries to expand. By having a distal portion or pin with surface 2312 on the inside of the proximal end 315 of the frame 350, the proximal end 315 is prevented from angling too far off parallel to the inner surface of the catheter 2200 as the frame expands (e.g., helping the proximal end 315 remain parallel, nearly parallel, or closer to parallel), which can help prevent or inhibit the frame 350 from popping out of the distal end of the catheter 2200.

[0219] 73A-75B, the frame 350 can include a sealing material or cover / coating 8000 disposed over the end 362 of the frame 350 to achieve a seal between the valve 29 and the inner surface 416 of the circulatory system when the valve 29 is disposed in the valve seat 18 of the frame 350 and when the frame 350 is radially expanded and installed in the body. The cover 8000 can be a cylinder partially rolled back on itself or can be substantially cylindrical and can have an end 8002 having an inner diameter 8004, an outer diameter 8006, a distal surface 8008, and a proximal surface 8010. The cover 8000 can include a single sheet of PET (polyethylene terephthalate), PTFE, ePTFE, another polymer, or other biocompatible material capable of providing an effective seal. In one embodiment, the cover 8000 can include a woven ribbon or fabric, such as a woven ribbon or fabric including PET, PTFE, ePTFE, another polymer, or other biocompatible material.

[0220] As shown in FIGS. 74A-75B, the cover 8000 may be disposed over the end 362 of the frame 350. The cover 8000 may be secured to the frame 350 in a variety of different manners. For example, the cover 8000 may be attached to the frame by sutures, glued, tied, melted, etc. Looking to FIGS. 74A and 74B, the cover 8000 may be placed over the end 362 of the frame 350. In one embodiment, the end 8002 of the cover 8000 abuts the end 362 of the frame 350. The inner diameter 8004 of the cover 8000 is radially inward of and adjacent to the inner diameter 364 of the frame 350. The outer diameter 8006 of the cover 8000 is radially outward of and adjacent to the outer diameter 366 of the frame 350. The proximal surface 8010 of the cover 8000 can extend around a portion of the retaining portion 314 of the frame 350. In one embodiment, the outer diameter 8006 of the cover provides a tight fit and / or seal between the frame 350 and the inner surface 416 of the circulatory system.

[0221] 75A and 75B, the cover 8000 may be draped or otherwise disposed generally around the end 362 of the frame 350. The cover 8000 may be contoured or otherwise contoured between the struts 1200 of the frame 350 (FIG. 75A), or the cover 8000 may be flush with the end 362 of the frame 3530 (FIG. 75B). The valve 29 (see, e.g., FIG. 63) may be inserted into the valve seat 18 defined by the inner diameter 364 of the frame 350 and the inner diameter 8004 of the cover 8000. In such a configuration, the cover 8000 may achieve a continuous seal between the outer diameter 366 of the frame 350 and the inner surface 416 of the circulatory system, around the end 362 of the frame 350, and between the inner diameter 364 of the frame 350 and the valve 29. For example, when valve 29 is in a closed position, valve 29 and cover 8000 provide a seal against blood flow.

[0222] For example, with reference to FIGS. 25, 26, and 76, the frame 350 may also include one or more friction enhancing features, such as barbs 2518 shown in FIG. 76 projecting radially outward from the retaining portion 314 of the frame 350. The barbs 2518 may be curved and / or otherwise oriented to prevent the frame 350 from moving from its installed position. In one embodiment, the barbs 2518 project radially outward from one or more struts 1200. As shown in FIG. 76, when the frame 350 is deployed and expanded radially outward, the barbs 2518 may insert into the inner surface 416 of the circulatory system to secure or otherwise maintain the position of the frame 2518. The barbs 2518 may be oriented (e.g., angled or curved to point in the direction of blood flow) to prevent the frame 350 from moving due to the force of blood flowing through the heart or other parts of the body. Any frame 350 described or illustrated herein may include similar barbs 2518.

[0223] As mentioned above, the docking station 10 can be adapted for use in a variety of different locations within the circulatory system. FIGS. 77 and 78 illustrate an exemplary embodiment in which the docking station 10 is configured for use within the aorta 900. In FIG. 77, the docking station 10 is shown being used alone within the aorta. In FIG. 78, the docking station 10 is shown being used with a graft 902. The docking station 10 used within the aorta 900 can take a wide variety of different forms. For example, the docking station 10 shown in FIGS. 77 and 78 can be any of the docking stations 10 disclosed herein.

[0224] 77 and 78, the docking station may be placed in the aorta 900 with the extension 950 extending to stabilize the docking station 10. In FIG. 77, the docking station 10 is placed inside the annulus of the aortic valve AV and the extension 950 extends into the aorta, such as into the aortic arch. In FIG. 78, the docking station 10 is placed inside the annulus of the aortic valve AV and the extension 950 extends into the aorta, such as into the graft 902. However, the extension 950 and the graft 902 can take a wide variety of different forms. The graft can be a surgically installed graft or a graft installed through a catheter without open-heart surgery. In one exemplary embodiment, the extension acts as the graft.

[0225] The extension 950 can take a wide variety of different forms. In one exemplary embodiment, the extension 950 is constructed to allow blood to flow freely through the extension. For example, the extension 950 can be an open cell frame. The extension 950 can include spring elements 3700. The extension 950 can include wires. In one exemplary embodiment, the extension 950 includes an open cell frame, spring elements 3700, and / or wires. In the illustrated embodiment, the extension 950 is configured to bend as it extends into the aorta. The extension 950 can be integrally formed with the docking station 10, or the extension can be made separately from the docking station 10 and attached to the docking station. Optionally, the extension 950 can be configured as a graft or stent graft.

[0226] 77 and 78, when the docking station 10 is installed in the aorta, a significant volume of blood flowing through the aorta can be directed into the valve 29 by the covering / material 21. The covering / material 21 can be the same as or similar to other coverings / materials described herein. The covering / material can be fluid impermeable or can be substantially impermeable such that blood cannot pass through. More or all of the docking station frame 350 can be provided with the covering / material 21, forming a relatively large or substantially impermeable portion.

[0227] The foregoing primarily describes embodiments of docking stations that are self-expanding. However, the docking stations shown and described herein may be modified for delivery of balloon-expandable, mechanically-expandable docking devices, and / or combinations thereof, within the scope of the present disclosure. Also, delivery of balloon-expandable and / or mechanically-expandable docking stations, etc., to an implantation site may be implemented.

[0228] Various methods of implanting the docking station and valve described herein may be used. The steps described herein may be used in various orders, and various steps may be combined or omitted. As one example, a method may include the steps of: inserting a docking station delivery catheter / sheath into a patient's vasculature (or circulatory system), where the docking station holds the docking station in a compressed configuration; navigating the docking station delivery catheter / sheath through the vasculature (or circulatory system) to a desired implantation location / site; deploying / releasing the docking station, where the docking station expands to an expanded configuration and engages an interior surface of the circulatory system, vasculature, heart, or the like; and inserting a valve delivery catheter (e.g., a THV delivery catheter) into the vasculature (or circulatory system), where the valve delivery catheter holds the transcatheter valve in a compressed configuration. The method may include the steps of: navigating the valve delivery catheter through the vascular system (or circulatory system) to the desired implantation location / site or to a docking station (e.g., into the docking station or into the valve seat of the docking station); and deploying / releasing the valve, where the valve expands to an expanded configuration and engages and is securely held by an inner surface of the docking station or an inner surface of the valve seat of the docking station (allowing the transcatheter valve to self-expand out of the catheter / sheath, expansion may be accomplished by inflating a balloon, manually expanding the valve, mechanically expanding the valve, or a combination thereof).

[0229] The step of deploying / releasing the docking station can include a partial deployment / release of the docking station such that a portion of the docking station remains within the catheter / sheath such that the docking station expands to an expanded configuration and engages the internal surfaces of the vasculature, IVC, SVC, aorta, aortic valve, heart, circulatory system, etc. A step of retrieving or recapturing the docking station can be used (whether fully deployed or partially deployed) and may require retracting the docking station into the sheath / catheter or advancing the sheath / catheter over the docking station. In the case of retrieval or recapture, a step of repositioning the docking station catheter / sheath and docking station to a second or different / revised location can be used and then the docking station can be fully deployed / released such that the docking station expands to an expanded configuration and engages the internal surfaces of the vasculature, IVC, SVC, aorta, aortic valve, heart, circulatory system, etc.

[0230] In view of the many possible embodiments to which the principles of the disclosed invention may be applied, the illustrated embodiments are merely examples of the invention and should not be taken as limiting the scope of the invention. All combinations or subcombinations of the features / components of the foregoing exemplary embodiments are contemplated by this application, e.g., features / components of one embodiment may be combined into other embodiments, and various method steps may be combined in differing manners and orders. We therefore claim as our invention all that comes within the scope and spirit of the following claims. [Explanation of symbols]

[0231] 10 Docking Station 18 Valve seat 20 Bands 21 Covering / Materials 29 Valves 210 Arrow 212 Arrow 228 Space 252 Area 310 Sealing part 314 Retaining part 315 Proximal end 317 Distal end 319 Leg / Extension 321 End shape / foot part 323 Long and thin legs / extensions 325 End / Foot 327 Distal part 350 frames 362 End 364 Inner diameter 366 Outer diameter 368 Annular outer part or wall 377 Arrow 378 Arrow 379 Area 416 Internal surface 500 Covering materials 710 Foam Piece 712 frames 750 outer frame ring 752 Inner frame ring 810 Inner surface 900 Aorta 902 Graft 910 outer surface 950 Extension 1150 curve 1152 area 1154 area 1200 Strut 1202 Strut section or link 1204 Top or apex 1206 Bend 1210 Taper 1250 Leg 1500 Twist 1510 Joint 1520 Joint 1550 offset / rotation 1560 Axial outward movement 1700 offset / rotation 1710 Joint 1720 Joint 1760 Axial outward movement 2000 Sharp Bend 2010 Leg part 2020 Rounded ends or tips 2022 Bend 2030 Rounded end extending downwards 2032 A rounded part extending upward 2100 Crimping Machine 2101 Housing 2102 Wedge-shaped drive member 2110 Clockwise 2120 Upper end of valve seat 2122 Bottom edge of valve seat 2130 Counterclockwise direction 2200 Catheter 2202 Lumen / Delivery Channel 2203 Inner surface 2204 Proximal opening 2206 Distal opening 2220 Radial outward 2222 Carl Back 2224 Upper 2226 Last part of the docking station 2228 Last part of the docking station 2230 Radial outward 2300 Pusher 2302 Distal end 2304 Outer Circumferential Surface 2306 Slots 2308 Long and narrow slot 2310 Suture passage 2312 first outer circumferential surface 2314 Second outer circumferential surface 2400 Leaflet 2420 Radial outward 2422 Carl Back 2424 Back 2426 Clamp 2428 Docking Station Parts 2500 Inner Strut 2502 End 2504 Joint 2506 Generally diamond shaped opening 2510 Top and Outer Struts 2512 Second end 2516 Continuous opening 2518 Barb 2600 Inner Strut 2601 Leg 2602 End 2604 Joint 2606 Opening 2610 Top and Outer Struts 2612 Second end 2616 Continuous opening 2700 Sutures 2904 Cell 2912 Relatively wider inlet 2916 Relatively narrower part 2918 Tapered section 3216 Round or outer segment 3400 Inner strut 3410 Lower strut 3412 Lower end 3450 Radial outward 3452 Downward 3454 Inward 3520 Top and Outer Struts 3530 Line 3550 The upper part of line 3530 3552 The part below line 3530 3610 Seal 3612 Atrial-venous junction 3616 Radial outward movement 3617 End 3618 Enlarged part or skirt 3700 Spring / Flexible Segment 3702 Frame or stent segment 3800 bends 3802 One side 3804 Another Side 3900 inflatable 3902 Compressible 4000 cells 4002 Opening 4010 Straps / Struts 4012 Notch 4100 Blood vessels 4110 First stent or frame segment 4112 Expand to first size 4120 Second stent or frame segment 4122 Expands to second size 4130 bend 4200 Dual Docking Station 4210 1st Docking Station 4212 Second Docking Station 4250 connection part 4260 Open Cell Frame 4262 Wire 4500 Tricuspid valve 4610 Radially expandable sealing and retaining part 4612 Material 4614 Line or Code 4620 First end 4630 Second end 4660 Stent or frame 4800 Radially outwardly extending end 4900 Ends that do not extend radially outward 4916 Narrow part 4918 Tapered section 5100 Coil 5110 Larger diameter coil segments 5112 Smaller diameter segments 5316 Narrow part 5318 Arm 5328 Upper Arm 5338 Lower Arm 5370 Adjustable Cords, Lines, or Wires 5380 Inner end 5381 End of narrow part 5316 5390 Outer edge 5592 Axial movement 5593 Radial 5594 Axial movement 5710 Outer Engagement Surface 5712 Periphery 5714 Inner part 5716 Outer part 5900 Coil 5902 Coil Ring 5910 Larger diameter coil ring 5912 Smaller diameter coil ring 6000 End of inner ring 6002 End 6010 Line 6020 Extension 6030 Extension 6040 Connection part 6050 Loop 7000 Docking Station Placement Assembly / System 8000 Sealing materials or covers / coverings 8002 End 8004 Inner diameter 8006 Outer diameter 8008 Distal Surface 8010 Proximal Surface A Longitudinal or central axis H1 Height of foam piece 710 H2 Ring 750, 752 height T1, T2, T3 thickness W1, W2, W3 width α, θ, β acute angles AV aortic valve CS Coronary sinus H Heart IVC Inferior vena cava LA Left atrium LV left ventricle MV Mitral valve PA pulmonary artery PV Pulmonary valve RA right atrium RV right ventricle SVC Superior vena cava TV Tricuspid Valve

Claims

1. a docking station frame for docking with an artificial valve, the docking station frame being expandable and configured to conform to an internal shape of the blood vessel when expanded inside the blood vessel, the docking station frame comprising: an annular valve seat having a distal end configured to support the prosthetic valve; a cylindrical outer wall having a distal end including struts disposed about the valve seat; a plurality of links connecting the distal end of the annular valve seat to the distal end of the outer wall, the plurality of links being circumferentially spaced apart, each link contouring the distal end of the annular valve seat and the outer wall distally outwardly to form an apex defining a distal end of the inflatable docking station frame; Equipped with each link extends directly from the outer wall toward a longitudinal axis that extends longitudinally through a center of the docking station frame; The thickness of the link is less than the thickness of the strut. Expandable docking station frame.

2. 2. The expandable docking station frame of claim 1, further comprising a first leg portion extending proximally beyond the proximal end of the cylindrical outer wall, and an elongated second leg portion extending proximally beyond the proximal end of the cylindrical outer wall and further beyond the proximal end of the first leg portion.

3. The expandable docking station frame of claim 1 , wherein the links and struts are integrally formed with a transition portion transitioning from a thickness of the links to a thickness of the struts.

4. 2. The expandable docking station frame of claim 1, wherein the apexes of the links are bent such that portions of the links on either side of the apex extend away from each other at an acute angle.

Images