Docking Stations for Medical Devices

Abstract

The expandable docking station for docking an expandable valve can include a valve seat, one or more sealing portions, and / or one or more retention portions. The valve seat can include a radiopaque marker attached to the frame or opaque member. The radiopaque marker can indicate the deployed position of the valve. The docking station can be deployed from a catheter that includes one or more radiopaque markers. Relative positioning of two or more radiopaque markers can provide an indication of the amount of deployment of the docking station.

Description

[Technical field]

[0001] REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Application No. 62 / 991,687, filed March 19, 2020, and U.S. Provisional Application No. 63 / 137,619, filed January 14, 2021, the entire contents of which are incorporated herein by reference.

[0002] The present disclosure relates to heart valves, and in particular to docking stations / stents, delivery systems, and methods used in the implantation of heart valves, such as transcatheter heart valves ("THVs"). [Background technology]

[0003] Prosthetic heart valves can be used to treat valvular heart disease. The native heart valves (aortic, pulmonary, tricuspid, and mitral) serve the important function of ensuring proper forward flow of blood supply through the cardiovascular system. These heart valves can become less efficient due to congenital, inflammatory, or infectious diseases. Such diseases can ultimately lead to serious cardiovascular adverse events or death. For many years, the definitive treatment for such disorders has been to surgically repair or replace the valves during open-heart surgery.

[0004] Transcatheter techniques can also be used, in which a flexible catheter is used to introduce and implant a prosthetic heart valve in a manner that is less invasive than open-heart surgery. In this technique, the prosthetic valve can be mounted in a folded state on the end portion of a flexible catheter and advanced through the subject's blood vessels until the valve reaches the implantation site. The valve at the tip of the catheter can then be expanded to its functional size at the site of the defective native valve, such as by inflating a balloon carrying the valve. Alternatively, the valve can have a resilient self-expanding stent or frame that expands to its functional size when advanced from a delivery sheath at the distal end of the catheter.

[0005] Transcatheter heart valves (THVs) can be appropriately sized to be placed inside most native aortic valves. However, when the native valve, vessel, and graft are large, the aortic transcatheter valve may be too small to fit securely into a large implantation or deployment site. In this case, the transcatheter valve may not be large enough to expand sufficiently inside the native valve or other implantation or deployment site so as to be secured in place.

[0006] Replacement of the pulmonary valve, sometimes referred to as the pulmonic valve, poses significant challenges. Pulmonary artery geometry can vary greatly from patient to patient. Typically, the pulmonary outflow tract after corrective surgery is too wide for effective placement of a prosthetic heart valve. [Prior art documents] [Patent documents]

[0007] [Patent Document 1] U.S. Patent No. 8,002,825 [Patent Document 2] International Publication No. WO2000 / 42950 [Patent Document 3] U.S. Patent No. 5,928,281 [Patent Document 4] U.S. Patent No. 6,558,418 [Patent Document 5] U.S. Patent No. 6,540,782 [Patent Document 6] U.S. Patent No. 3,365,728 [Patent Document 7] U.S. Patent No. 3,824,629 [Patent Document 8] U.S. Patent No. 5,814,099 Summary of the Invention [Means for solving the problem]

[0008] This summary is intended to provide examples and is not intended to limit the scope of the invention in any way. For example, any feature included in this example summary is not essential to the claims unless the feature is explicitly recited in the claims. This specification discloses exemplary embodiments of an expandable docking station for an expandable valve, a catheter for the expandable docking station, and a handle for the catheter. The docking station, catheter, and handle can be constructed in a variety of ways.

[0009] In one exemplary embodiment, a docking station for a medical device includes a frame, a plurality of radiopaque markers, and an opaque material. The frame has a plurality of struts extending from a proximal end to a distal end. The struts define a plurality of cells and a valve seat. The radiopaque markers are disposed about the valve seat. The opaque material is attached to the frame.

[0010] In one exemplary embodiment, the system includes a tube and a docking station frame. The tube has one or more radiopaque markers. The docking station frame is disposed within the tube. The docking station includes one or more radiopaque markers. A position of the one or more radiopaque markers of the docking station relative to the radiopaque markers of the tube indicates an amount of deployment of the docking station from the tube.

[0011] In one exemplary method of deploying the docking station frame, a radiopaque marker on the docking station frame is positioned at a target location for deploying the valve seat of the docking station frame. A portion of the docking station frame is deployed from the tube such that the radiopaque marker on the tube is substantially aligned with the radiopaque marker on the docking station frame. The radiopaque marker on the tube and the radiopaque marker on the docking station frame visually confirm the target location. The docking station frame is further deployed and released from the tube.

[0012] In one exemplary embodiment, the system includes a delivery catheter assembly and a docking station frame. The delivery catheter assembly includes an outer tube and a connecting tube. The outer tube has a distal end and one or more radiopaque markers disposed at or near the distal end. The connecting tube has one or more radiopaque markers disposed within the outer tube. The docking station frame is disposed within the outer tube and coupled to the connecting tube. The docking station frame is deployed by retracting the outer tube proximally relative to the connecting tube and the docking station frame. A position of the one or more radiopaque markers of the connecting tube relative to the radiopaque markers of the outer tube indicates an amount of deployment of the docking station from the outer tube.

[0013] In one exemplary method of deploying the docking station frame, a portion of the docking station frame is deployed from the outer tube along with the connecting tube such that the radiopaque markers of the outer tube are closer to the radiopaque markers of the connecting tube, and the alignment of the radiopaque markers of the outer tube and the connecting tube indicates the final point at which the docking station frame can be recaptured by the outer tube.

[0014] In one exemplary embodiment, the system includes a delivery catheter assembly and a docking station frame. The delivery catheter assembly includes an elongated nosecone, an outer tube, a docking station connector, and a connecting tube. The outer tube has a distal end and one or more radiopaque markers disposed at or near the distal end. The docking station connector is movable within the outer tube. The connecting tube is disposed within the outer tube. The connecting tube includes one or more radiopaque markers disposed between the elongated nosecone and the docking station connector. The docking station frame is disposed within the outer tube and coupled to the docking station connector. The docking station frame includes one or more radiopaque markers. The docking station frame is deployed by proximally retracting the outer tube from the elongated nosecone. The radiopaque markers on the outer tube, the radiopaque markers on the connecting tube, and the radiopaque markers on the docking station frame are configured to visually determine one or more of the proper placement of the docking station frame and the final point at which the docking station frame can be recaptured by the outer tube.

[0015] In one exemplary embodiment, the assembly includes a frame, an elongated nosecone, an outer tube, a docking station connector, and a connecting tube. The frame has a valve seat and a plurality of radiopaque markers disposed about the valve seat. The outer tube has a distal end and one or more radiopaque markers disposed near the distal end. The docking station connector is movable within the outer tube. The connecting tube is disposed between the elongated nosecone and the docking station connector. The frame is deployed by proximally retracting the outer tube from the elongated nosecone.

[0016] Various embodiments and methods described herein can be utilized in a variety of procedures, including, but not limited to, medical procedures and training procedures, in subjects including, but not limited to, medical patients, veterinary patients, animal models, cadavers, and cardiovascular simulators (e.g., human body phantoms and artificially engineered tissues).

[0017] Various features as described anywhere in this disclosure may be included in the examples outlined herein, and various methods and steps may be used that utilize the examples and features, including those as described anywhere in this specification.

[0018] 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.

[0019] To further clarify various aspects of the embodiments of the present disclosure, certain embodiments will be described more particularly by reference to various aspects of the accompanying drawings. It will be appreciated that these drawings merely depict typical embodiments of the present disclosure and therefore should not be considered as limiting the scope of the present disclosure. Furthermore, the drawings may be drawn to scale for some embodiments, but are not necessarily drawn to scale for all embodiments. The embodiments of the present disclosure will be described and explained with additional specificity and detail using the accompanying drawings. [Brief description of the drawings]

[0020] [Figure 1A] FIG. 1 is a cut-away view of a human heart during diastole. [Figure 1B] FIG. 1 is a cut-away view of a human heart during systole. [Figure 2A] FIG. 1 is a cross-sectional view of a pulmonary artery showing that the pulmonary artery can have a variety of different shapes and sizes. [Figure 2B]FIG. 1 is a cross-sectional view of a pulmonary artery showing that the pulmonary artery can have a variety of different shapes and sizes. [Figure 2C] FIG. 1 is a cross-sectional view of a pulmonary artery showing that the pulmonary artery can have a variety of different shapes and sizes. [Figure 2D] FIG. 1 is a cross-sectional view of a pulmonary artery showing that the pulmonary artery can have a variety of different shapes and sizes. [Figure 2E] FIG. 1 is a cross-sectional view of a pulmonary artery showing that the pulmonary artery can have a variety of different shapes and sizes. [Figure 3A] FIG. 1 is a perspective view of a pulmonary artery showing that the pulmonary artery can have a variety of different shapes and sizes. [Figure 3B] FIG. 1 is a perspective view of a pulmonary artery showing that the pulmonary artery can have a variety of different shapes and sizes. [Figure 3C] FIG. 1 is a perspective view of a pulmonary artery showing that the pulmonary artery can have a variety of different shapes and sizes. [Figure 3D] FIG. 1 is a perspective view of a pulmonary artery showing that the pulmonary artery can have a variety of different shapes and sizes. [Figure 4A] FIG. 1 is a schematic diagram showing a compressed docking station positioned within the circulatory system. [Figure 4B] FIG. 4B is a schematic diagram showing the docking station of FIG. 4A expanded to position the docking station within the circulatory system. [Figure 4C] FIG. 4C is a schematic diagram showing an expandable transcatheter heart valve positioned in the docking station shown in FIG. 4B. [Figure 4D] FIG. 4D is a schematic diagram showing the transcatheter heart valve of FIG. 4C being expanded to position the heart valve within the docking station. [Figure 4E] FIG. 1 illustrates a docking station and transcatheter heart valve deployed within an irregularly shaped portion of the circulatory system. [Figure 4F] FIG. 1 illustrates a docking station and transcatheter heart valve deployed in the pulmonary artery. [Figure 5A] FIG. 1 is a schematic diagram showing a compressed docking station positioned within the circulatory system. [Figure 5B] FIG. 5B is a schematic diagram showing the docking station of FIG. 5A expanded to position the docking station within the circulatory system. [Figure 5C] FIG. 5C is a schematic diagram showing an expandable transcatheter heart valve positioned in the docking station shown in FIG. 5B. [Figure 5D] FIG. 5D is a schematic diagram showing the transcatheter heart valve of FIG. 5C being expanded to position the heart valve within the docking station. [Figure 5E] FIG. 1 illustrates a docking station and transcatheter heart valve deployed within an irregularly shaped portion of the circulatory system. [Figure 5F] FIG. 1 illustrates a docking station and transcatheter heart valve deployed in the pulmonary artery. [Figure 6A] FIG. 1 is a cut-away view of a human heart in systole with a docking station deployed within the pulmonary artery. [Figure 6B] FIG. 1 is a cut-away view of a human heart in systole with a docking station and a transcatheter heart valve deployed in the pulmonary artery. [Figure 7A] FIG. 6C is an enlarged schematic diagram showing the docking station and transcatheter heart valve of FIG. 6B when the heart is in systole. [Figure 7B] 7B is a view taken in the direction indicated by line 7B-7B in FIG. 7A. [Figure 7C] 1 is a graph illustrating the relationship between the diameter of a docking station and the radial outward force exerted by the docking station. [Figure 8] FIG. 1 is a cut-away view of a human heart in diastole with a docking station and a transcatheter heart valve deployed in the pulmonary artery. [Figure 9A] FIG. 9 is an enlarged schematic diagram showing the docking station and transcatheter heart valve of FIG. 8 when the heart is in diastole. [Figure 9B]9B is a view taken in the direction indicated by line 9B-9B in FIG. 9A. [Figure 10A] FIG. 1 illustrates an exemplary embodiment of a docking station in which a transcatheter heart valve is disposed within the docking station. [Figure 10B] FIG. 1 illustrates an exemplary embodiment of a docking station in which a transcatheter heart valve is disposed within the docking station. [Figure 10C] FIG. 1 illustrates an exemplary embodiment of a docking station in which a transcatheter heart valve is disposed within the docking station. [Figure 10D] FIG. 1 illustrates an exemplary embodiment of a docking station in which a transcatheter heart valve is disposed within the docking station. [Figure 11A] FIG. 1 illustrates an exemplary embodiment of a nestable docking station. [Figure 11B] FIG. 1 illustrates an exemplary embodiment of a nestable docking station. [Figure 11C] FIG. 1 illustrates an exemplary embodiment of a nestable docking station. [Figure 11D] FIG. 1 illustrates an exemplary embodiment of a nestable docking station. [Figure 12A] FIG. 1 illustrates an exemplary embodiment of a docking station in which a transcatheter heart valve is disposed within the docking station. [Figure 12B] FIG. 1 illustrates an exemplary embodiment of a docking station in which a transcatheter heart valve is disposed within the docking station. [Figure 12C] FIG. 1 illustrates an exemplary embodiment of a docking station in which a transcatheter heart valve is disposed within the docking station. [Figure 12D] FIG. 1 illustrates an exemplary embodiment of a docking station in which a transcatheter heart valve is disposed within the docking station. [Figure 13A]FIG. 1 illustrates an exemplary embodiment of a nestable docking station. [Figure 13B] FIG. 1 illustrates an exemplary embodiment of a nestable docking station. [Figure 13C] FIG. 1 illustrates an exemplary embodiment of a nestable docking station. [Figure 13D] FIG. 1 illustrates an exemplary embodiment of a nestable docking station. [Figure 14A] FIG. 1 illustrates an exemplary embodiment of a docking station in which a transcatheter heart valve is disposed within the docking station. [Figure 14B] FIG. 1 illustrates an exemplary embodiment of a docking station in which a transcatheter heart valve is disposed within the docking station. [Figure 14C] FIG. 1 illustrates an exemplary embodiment of a docking station in which a transcatheter heart valve is disposed within the docking station. [Figure 14D] FIG. 1 illustrates an exemplary embodiment of a docking station in which a transcatheter heart valve is disposed within the docking station. [Figure 14E] FIG. 1 illustrates an exemplary embodiment of a docking station in which a transcatheter heart valve is disposed within the docking station. [Figure 14F] FIG. 1 illustrates an exemplary embodiment of a docking station in which a transcatheter heart valve is disposed within the docking station. [Figure 14G] FIG. 1 illustrates an exemplary embodiment of a docking station in which a transcatheter heart valve is disposed within the docking station. [Figure 15A] FIG. 2 is a side view of an exemplary embodiment of a frame of a docking station. [Figure 15B] FIG. 15B shows a cross section of the frame shown in FIG. 15A. [Figure 16] FIG. 15B shows the docking station frame of FIG. 15A in a compressed state. [Figure 17A] FIG. 15B is a perspective view of the docking station frame of FIG. 15A. [Figure 17B] FIG. 15B is a perspective view of the docking station frame of FIG. 15A. [Figure 18] FIG. 2 is a perspective view illustrating an exemplary embodiment of a docking station having a plurality of coated cells and a plurality of open cells. [Figure 19] FIG. 19 is a perspective view of the docking station shown in FIG. 18 with a portion cut away to show the transcatheter heart valve expanded into position within the docking station. [Figure 20] FIG. 19 shows a cross-section of the docking station shown in FIG. 18 when implanted in a vessel of the circulatory system. [Figure 21] FIG. 19 is a perspective view showing the docking station shown in FIG. 18 when loaded into a vessel of the circulatory system. [Figure 22] FIG. 20 is a perspective view showing the docking station and valve shown in FIG. 19 when implanted in a vessel of the circulatory system. [Figure 23A] 19A-19C show cross-sections of the docking station shown in FIG. 18 when implanted in vessels of different sizes of the circulatory system. [Figure 23B] 19A-19C show cross-sections of the docking station shown in FIG. 18 when implanted in vessels of different sizes of the circulatory system. [Figure 24] 19A-19C show cross-sections of the docking station shown in FIG. 18 when implanted in vessels of different sizes in the circulatory system with transcatheter heart valves, shown diagrammatically to be of the same size, loaded or deployed in each docking station. [Diagram 25] 19A-19C show cross-sections of the docking station shown in FIG. 18 when implanted in vessels of different sizes in the circulatory system with transcatheter heart valves, shown diagrammatically to be of the same size, loaded or deployed in each docking station. [Figure 26A]FIG. 1 is a cross-sectional view showing a cross section of an exemplary embodiment of a docking station positioned within the pulmonary artery. [Figure 26B] FIG. 2 is a cross-sectional view showing a cross section of an exemplary embodiment of a docking station disposed within a pulmonary artery and a valve, shown diagrammatically, disposed within the docking station. [Figure 26C] 1 is a cross-sectional view illustrating an exemplary embodiment of a docking station disposed within a pulmonary artery and a valve disposed within the docking station. [Figure 27] FIG. 2 is a side view of an exemplary embodiment of a docking station. [Figure 28] FIG. 2 is a side view of an exemplary embodiment of a nestable docking station. [Figure 29] FIG. 29 is a side view showing the docking station of FIG. 28 with the two portions of the docking station nested within one another. [Diagram 30] FIG. 13 is a cross-sectional view showing a docking station positioned within the pulmonary artery. [Figure 31A] FIG. 1 is a cross-sectional view showing a cross section of an exemplary embodiment of a docking station positioned within the pulmonary artery. [Figure 31B] FIG. 1 is a cross-sectional view showing a cross section of an exemplary embodiment of a docking station disposed in a pulmonary artery and a valve disposed in the docking station. [Figure 32A] FIG. 1 is a cut-away view of a human heart in systole with a docking station deployed within the pulmonary artery. [Figure 32B] FIG. 1 is a cut-away view of a human heart in systole with a docking station and a transcatheter heart valve deployed in the pulmonary artery. [Figure 33A] FIG. 32C is an enlarged schematic diagram showing the docking station and transcatheter heart valve of FIG. 32B when the heart is in systole. [Figure 33B] 33B is a view taken in the direction indicated by line 33B-33B in FIG. 33A. [Diagram 34]FIG. 32C is a cutaway view showing a human heart, a docking station deployed in the pulmonary artery shown in FIG. 32B, and a transcatheter heart valve when the heart is in diastole. [Figure 35A] FIG. 35 is an enlarged schematic diagram showing the docking station and transcatheter heart valve of FIG. 34 when the heart is in diastole. [Figure 35B] 35B is a view taken in the direction indicated by line 35B-35B in FIG. 35A. [Figure 36A] FIG. 1 is a cut-away view of a human heart in systole with a docking station deployed within the pulmonary artery. [Figure 36B] FIG. 1 is a cut-away view of a human heart in systole with a docking station deployed within the pulmonary artery. [Figure 36C] FIG. 1 is a cut-away view of a human heart in systole with a docking station and a transcatheter heart valve deployed in the pulmonary artery. [Figure 37A] FIG. 36D is an enlarged schematic diagram showing the docking station and transcatheter heart valve of FIG. 36C when the heart is in systole. [Figure 37B] 37B is a view taken in the direction indicated by line 37B-37B in FIG. 37A. [Figure 38] FIG. 36D is a cutaway view of a human heart, a docking station deployed in the pulmonary artery as shown by FIG. 36C, and a transcatheter heart valve when the heart is in diastole. [Figure 39A] FIG. 39 is an enlarged schematic diagram showing the docking station and transcatheter heart valve of FIG. 38 when the heart is in diastole. [Figure 39B] 39B is a view taken in the direction indicated by line 39B-39B in FIG. 39A. [Figure 40A] FIG. 1 is a cut-away view of a human heart in systole with a docking station deployed within the pulmonary artery. [Figure 40B] FIG. 1 is a cut-away view of a human heart in systole with a docking station deployed within the pulmonary artery. [Figure 40C]FIG. 1 is a cut-away view of a human heart in systole with a docking station and a transcatheter heart valve deployed in the pulmonary artery. [Figure 41A] FIG. 4OD is an enlarged schematic diagram showing the docking station and transcatheter heart valve of FIG. 40C when the heart is in systole. [Figure 41B] 41B is a view taken in the direction indicated by line 41B-41B in FIG. 41A. [Diagram 42] FIG. 40C is a cutaway view of a human heart, a docking station deployed in the pulmonary artery, and a transcatheter heart valve as shown in FIG. 40A when the heart is in diastole. [Figure 43A] FIG. 43 is an enlarged schematic diagram showing the docking station and transcatheter heart valve of FIG. 42 when the heart is in diastole. [Figure 43B] 43B is a view taken in the direction indicated by line 43B-43B in FIG. 43A. [Diagram 44] 1A-1C show examples of types of valves that may be deployed in a docking station, such as one of the docking stations described or depicted herein. [Diagram 45] 1A-1C show examples of types of valves that may be deployed in a docking station, such as one of the docking stations described or depicted herein. [Diagram 46] 1A-1C show examples of types of valves that may be deployed in a docking station, such as one of the docking stations described or depicted herein. [Figure 47] 1A-1C show examples of types of valves that may be deployed in a docking station, such as one of the docking stations described or depicted herein. [Figure 48A] 1A-1C show examples of types of valves that may be deployed in a docking station, such as one of the docking stations described or depicted herein. [Figure 48B] 1A-1C show examples of types of valves that may be deployed in a docking station, such as one of the docking stations described or depicted herein. [Figure 48C] 1A-1C show examples of types of valves that may be deployed in a docking station, such as one of the docking stations described or depicted herein. [Figure 49A] FIG. 1 is a cross-sectional view of an exemplary embodiment of a catheter. [Figure 49B] FIG. 1 is a cross-sectional view of an exemplary embodiment of a catheter with a docking station folded and loaded onto the catheter. [Figure 50A] FIG. 13 illustrates deployment of a docking station from a catheter. [Figure 50B] FIG. 13 illustrates deployment of a docking station from a catheter. [Figure 50C] FIG. 13 illustrates deployment of a docking station from a catheter. [Figure 50D] FIG. 13 illustrates deployment of a docking station from a catheter. [Figure 51] FIG. 2 is a side view of an exemplary embodiment of a catheter nosecone. [Figure 52] 52 is a view as indicated by line 52-52 in FIG. 51. [Diagram 53] FIG. 2 is a side view of an exemplary embodiment of a distal portion of a catheter. [Figure 54] FIG. 2 is a side view of an exemplary embodiment of a catheter nosecone. [Figure 55] FIG. 2 is a side view of an exemplary embodiment of a distal portion of a catheter. [Figure 56] FIG. 13 is a perspective view showing a holder for holding the docking station within the catheter. [Figure 57] FIG. 13 is a perspective view showing a holder for holding the docking station within the catheter. [Figure 57A] FIG. 13 is a side view showing an extension of the docking station disposed within the holder. [Figure 57B] FIG. 13 is a side view showing an extension of the docking station disposed within the holder. [Figure 58] FIG. 1 is a cross-sectional view of an exemplary embodiment of a handle of a docking station catheter. [Figure 59] FIG. 59 is an exploded perspective view of a portion of the handle of FIG. 58. [Figure 60] FIG. 59 is an exploded cross-sectional view of a portion of the handle of FIG. 58. [Figure 61] FIG. 59 is an exploded perspective cross-sectional view of a portion of the handle of FIG. 58. [Figure 62] FIG. 1 illustrates an exemplary embodiment of a handle for a docking station catheter with the side cover removed. [Figure 63] FIG. 63 is an enlarged partial view of FIG. 62 showing the catheter cleaning system. [Fig. 64A] FIG. 63 is a view of the handle shown in FIG. 62 with the opposite side cover removed to show extension and retraction of the outer sleeve of the docking station catheter. [Fig. 64B] FIG. 63 is a view of the handle shown in FIG. 62 with the opposite side cover removed to show extension and retraction of the outer sleeve of the docking station catheter. [Figure 65] FIG. 63 is an exploded view of the handle of FIG. 62. [Figure 66] FIG. 63 is a perspective view of the handle shown in FIG. 62 with the opposite side cover removed. [Figure 67] FIG. 63 is a side view of the handle shown in FIG. 62. [Figure 68] FIG. 63 is a side view showing the indexing wheel of the handle shown in FIG. 62 in a ratcheting state. [Figure 69] FIG. 69 is a perspective view showing the index wheel of FIG. 68 in a ratcheting position. [Figure 70] FIG. 70 is an enlarged partial view of FIG. 69. [Figure 71] FIG. 69 is a partial cross-sectional view showing the index wheel shown in FIG. 68 disposed within the handle housing. [Figure 72] 72 is a view similar to FIG. 71 in a disengaged state. [Figure 73] FIG. 63 is a side view showing the index wheel of the handle shown in FIG. 62 in a disengaged state. [Figure 74] FIG. 2 is a side view of one embodiment of a frame of a docking station. [Figure 75] FIG. 13 is a side view of another embodiment of a frame of the docking station. [Figure 76A] FIG. 2 is a side view of one embodiment of a frame of a docking station. [Figure 76B] FIG. 76B is a bottom view of the frame of FIG. 76A. [Figure 76C] FIG. 76B is a top view of the frame of FIG. 76A. [Figure 77A] FIG. 13 is a side view of another embodiment of a frame of the docking station. [Fig. 77B] FIG. 77B is a bottom view of the frame of FIG. 77A. [Fig. 77C] FIG. 77B is a top view of the frame of FIG. 77A. [Fig. 78A] FIG. 1 illustrates a side view of one embodiment of a docking station having an effusion cell. [Fig. 78B] FIG. 78B is a top view of the docking station of FIG. 78A. [Figure 79] FIG. 13 is a side view of another embodiment of a docking station having an effusion cell. [Figure 80A] FIG. 2 is a side view showing a frame of the docking station of one embodiment. [Figure 80B] FIG. 13 is a side view showing a frame of a docking station according to another embodiment. [Fig. 80C] FIG. 13 is a side view showing a frame of a docking station according to another embodiment. [Figure 81A] FIG. 1 illustrates a side view of a docking station having a frame and impermeable material according to one embodiment. [Fig. 81B] FIG. 13 is a side view illustrating a docking station having a frame and an impermeable material according to another embodiment. [Fig. 81C]FIG. 13 is a side view illustrating a docking station having a frame and an impermeable material according to another embodiment. [Fig. 81D] FIG. 13 is a side view illustrating a docking station having a frame and an impermeable material according to another embodiment. [Fig. 82A] FIG. 1 illustrates a superior component of impermeable material having proximal and distal portions. [Fig. 82B] FIG. 82B is a side perspective view showing the assembled proximal portion of the impermeable material of FIG. 82A. [Fig. 82C] FIG. 82B is a top perspective view showing the assembled proximal portion of the impermeable material of FIG. 82A. [Fig. 82D] FIG. 82B is a side perspective view showing the assembled distal portion of the impermeable material of FIG. 82A. [Fig. 82E] FIG. 82B is a side perspective view showing the assembly of impermeable material of FIG. 82A. [Fig. 82F] FIG. 82B is a side perspective view showing the assembly of impermeable material of FIG. 82A. [Fig. 82G] FIG. 82B is a side perspective view showing the assembly of impermeable material of FIG. 82A. [Fig. 82H] FIG. 82B is a side perspective view showing the assembly of impermeable material of FIG. 82A. [Fig. 82I] FIG. 82B is a side perspective view showing the assembly of impermeable material of FIG. 82A. [Fig. 82J] FIG. 82B is a top schematic diagram showing the proximal and distal portions of FIG. 82A outlined on a fabric according to one embodiment. [Figure 82K] FIG. 82B is a top schematic diagram showing the proximal and distal portions of FIG. 82A outlined on a fabric according to another embodiment. [Figure 83] FIG. 2 is a side view of an embodiment of an impermeable material disposed within an embodiment of a frame. [Fig. 84A] FIG. 84 illustrates one method of attaching the impermeable material and frame of FIG. 83 to one another. [Fig. 84B] FIG. 84 illustrates one method of attaching the impermeable material and frame of FIG. 83 to one another. [Fig. 84C] FIG. 84 illustrates one method of attaching the impermeable material and frame of FIG. 83 to one another. [Fig. 84D] FIG. 84 illustrates one method of attaching the impermeable material and frame of FIG. 83 to one another. [Fig. 84E] FIG. 84 illustrates one method of attaching the impermeable material and frame of FIG. 83 to one another. [Fig. 84F] FIG. 84 illustrates one method of attaching the impermeable material and frame of FIG. 83 to one another. [Fig. 84G] FIG. 84 illustrates one method of attaching the impermeable material and frame of FIG. 83 to one another. [Fig. 84H] FIG. 84 illustrates one method of attaching the impermeable material and frame of FIG. 83 to one another. [Fig. 84I] FIG. 84 illustrates one method of attaching the impermeable material and frame of FIG. 83 to one another. [Fig. 85A] FIG. 84 shows an alternative method of attaching the impermeable material and frame of FIG. 83 to one another. [Fig. 85B] FIG. 84 shows an alternative method of attaching the impermeable material and frame of FIG. 83 to one another. [Fig. 85C] FIG. 84 shows an alternative method of attaching the impermeable material and frame of FIG. 83 to one another. [Fig. 85D] FIG. 84 shows an alternative method of attaching the impermeable material and frame of FIG. 83 to one another. [Fig. 85E] FIG. 84 shows an alternative method of attaching the impermeable material and frame of FIG. 83 to one another. [Figure 86A] FIG. 1 is a side perspective view of a radiopaque marker according to one embodiment. [Figure 86B] FIG. 13 is a side perspective view of a radiopaque marker according to another embodiment. [Figure 86C] FIG. 13 is a side perspective view of a radiopaque marker according to another embodiment. [Fig. 86D] FIG. 13 is a side perspective view of a radiopaque marker according to another embodiment. [Fig. 87A] FIG. 13 is a side perspective view of a frame having marker settings according to one embodiment. [Fig. 87B] FIG. 13 is a side perspective view showing a frame having a marker setting according to another embodiment. [Fig. 87C] FIG. 13 is a side perspective view showing a frame having a marker setting according to another embodiment. [Figure 88] FIG. 2 is a schematic diagram showing radiopaque markers arranged in a marker setting. [Figure 89A] FIG. 1 is a perspective view of an opaque material having radiopaque markers according to one embodiment. [Figure 89B] FIG. 13 is a side view showing an opaque material with a radiopaque marker disposed within the pocket. [Figure 89C] FIG. 13 is a schematic diagram illustrating a pocket covering disposed over a pocket of impermeable material according to one embodiment. [Fig. 89D] 13 is a schematic diagram illustrating a pocket covering disposed over a pocket of impermeable material according to another embodiment. FIG. [Fig. 89E] 13A-13C illustrate a method of attaching the pocket and radiopaque markers to the opaque member. [Fig. 89F] 13A-13C illustrate a method of attaching the pocket and radiopaque markers to the opaque member. [Figure 89G] 13A-13C illustrate a method of attaching the pocket and radiopaque markers to the opaque member. [Fig. 89H] 13A-13C illustrate a method of attaching the pocket and radiopaque markers to the opaque member. [Fig. 89I] 89E-89H illustrate additional steps in the method of FIG. 89 according to one embodiment. [Fig. 89J] 89E-89H show additional steps in the method of FIG. 89E-H according to another embodiment. [Figure 89K] 89E-89H show additional steps in the method of FIG. 89E-H according to another embodiment. [Figure 89L]89E-89H show additional steps in the method of FIG. 89E-H according to another embodiment. [Figure 89M] 89E-89H show additional steps in the method of FIG. 89E-H according to another embodiment. [Fig. 89N] 89E-89H show additional steps in the method of FIG. 89E-H according to another embodiment. [Figure 90A] FIG. 1 is a side view illustrating a frame having radiopaque markers according to one embodiment. [Figure 90B] FIG. 13 is a side view showing a frame having radiopaque markers according to another embodiment. [Figure 90C] FIG. 13 is a side view showing a frame having radiopaque markers according to another embodiment. [Figure 91] FIG. 1 is a schematic diagram showing an expandable transcatheter heart valve positioned within a frame having radiopaque markers. [Figure 92A] FIG. 13 is a perspective view of a nose cone and outer tube having radiopaque markers according to one embodiment. [Fig. 92B] FIG. 92B is a partial cutaway perspective view of the nosecone and outer tube of FIG. 92A. [Fig. 92C] FIG. 13 is a perspective view of a nose cone and outer tube having multiple radiopaque markers according to another embodiment. [Figure 93A] FIG. 13 illustrates deployment of a delivery catheter assembly without a docking station frame. [Figure 93B] FIG. 13 illustrates deployment of a delivery catheter assembly without a docking station frame. [Figure 93C] FIG. 13 illustrates deployment of a delivery catheter assembly without a docking station frame. [Figure 94] FIG. 1 is a cross-sectional, partially cut-away view illustrating an exemplary embodiment of a catheter with a radiopaque marker and a docking station folded and loaded onto the catheter. [Figure 95A]FIG. 13 illustrates the deployment of a docking station having a radiopaque marker from a catheter having a radiopaque marker. [Figure 95B] FIG. 13 illustrates the deployment of a docking station having a radiopaque marker from a catheter having a radiopaque marker. [Figure 95C] FIG. 13 illustrates the deployment of a docking station having a radiopaque marker from a catheter having a radiopaque marker. [Figure 96A] FIG. 13 shows the deployment of a docking station having a radiopaque marker from a catheter having a radiopaque marker as viewed under X-ray fluoroscopy. [Figure 96B] FIG. 13 shows the deployment of a docking station having a radiopaque marker from a catheter having a radiopaque marker as viewed under X-ray fluoroscopy. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0021] 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 are directed to devices and methods that provide a docking station or landing area for a transcatheter heart valve ("THV"), such as THV 29. In some exemplary embodiments, the docking station for the THV is shown as being used in the pulmonary artery, but the docking station (e.g., docking station 10) can be used in other areas of the anatomy, heart, or vasculature, such as the superior or inferior vena cava. The docking stations described herein can be configured to compensate for the deployed THV being smaller than the space (e.g., anatomy / vasculature / etc.) in which the THV is placed.

[0022] The prosthesis including the docking station may be utilized in a variety of subjects and procedures. Subjects include, but are not limited to, medical patients, veterinary patients, animal models, cadavers, and cardiovascular simulators (e.g., human body phantoms and artificial tissues). Procedures include, but are not limited to, medical procedures and training procedures.

[0023] It should be noted that various embodiments of docking stations and systems for delivery and implantation are disclosed herein, and the options can be combined in any way unless specifically excluded. For example, any of the disclosed docking station devices can be used with any type of valve and / or any delivery system, even if a specific combination is not explicitly stated. Similarly, different structures of docking stations and valves can 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 can be combined, unless mutually exclusive or otherwise physically impossible.

[0024] For uniformity, in these figures and elsewhere in this application, the docking station is depicted with the pulmonary bifurcation end up and the ventricular end down. These orientations are sometimes referred to as "distal," which is synonymous with the superior or pulmonary bifurcation end, and "proximal," which is synonymous with the inferior or ventricular end, and are terms relative to the physician's perspective.

[0025] 1A and 1B are cutaway views of a human heart H during diastole and systole, 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. In addition, the aortic valve AV separates the left ventricle LV from the ascending aorta (not shown), and the pulmonary valve PV separates the right ventricle from the pulmonary artery PA. Each of these valves has flexible leaflets extending inwardly across their respective orifices that merge or "coapt" in flow to form a one-way fluid occlusion surface. The docking station and valves of this application are described primarily with respect to the pulmonary valve. Accordingly, the anatomical structures of the right atrium RA and right ventricle RV will be described in more detail. It should be understood that the devices described herein can also be used in other areas, such as, for example, in the inferior and / or superior vena cava as a treatment for a regurgitant or otherwise defective tricuspid valve, in the aorta as a treatment for a defective aortic valve (e.g., aortic hypertrophy), in other areas of the heart or vascular system, in grafts, etc.

[0026] The right atrium RA receives deoxygenated blood from the venous system through the superior vena cava SVC, which enters 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 that join together to form a large vessel that collects deoxygenated blood from the heart muscle (myocardium) and delivers it to the right atrium RA. During diastole or diastole, as seen in FIG. 1A, venous blood that collects in the right atrium RA enters the tricuspid valve TV by the expansion of the right ventricle RV. During systole or systole, as seen in FIG. 1B, the right ventricle RV contracts to push venous blood through the pulmonary valve PV and the pulmonary artery to the lungs. In an exemplary embodiment, the device described by the present application is used to replace or supplement the function of a defective pulmonary valve. During systole, the leaflets of the tricuspid valve TV close to prevent venous blood from flowing backwards and returning to the right atrium RA.

[0027] With reference to Figures 2A-2E and 3A-3D, the illustrated non-exhaustive examples show that pulmonary arteries can have a wide variety of different shapes and sizes. For example, as shown in the cross-sectional views of Figures 2A-2E and the oblique views of Figures 3A-3D, the length L, diameter D, and curvature or contour can vary significantly between pulmonary arteries of different patients. Furthermore, the diameter D can vary significantly along the length L of an individual pulmonary artery. These differences can be even more pronounced in pulmonary arteries that suffer from certain diseases and / or are compromised by previous surgical procedures. For example, treatment of tetralogy of Fallot (TOF) or transposition of the great arteries (TGA) often results in larger, more irregularly shaped pulmonary arteries.

[0028] Tetralogy of Fallot (TOF) is a cardiac anomaly that commonly refers to a combination of four related heart defects that occur together: ventricular septal defect (VSD), aortic overriding (the aortic valve is enlarged and appears to exit both the left and right ventricles instead of the left ventricle as in a normal heart), pulmonary stenosis (narrowing of the pulmonary valve and the outflow tract or area below the valve, causing obstruction of blood flow from the right ventricle to the pulmonary artery), and right ventricular hypertrophy (thickening of the muscular wall of the right ventricle caused by the right ventricle pumping at high pressure).

[0029] Transposition of the great arteries (TGA) refers to an abnormality in which the aorta and pulmonary artery are "transposed" from their normal positions, so that the aorta emerges from the right ventricle and the pulmonary artery emerges from the left ventricle.

[0030] Surgical treatment of some diseases requires a longitudinal incision along the pulmonary artery up to one of the pulmonary artery branches. This incision may eliminate or significantly impair the function of the pulmonary valve. A transannular patch is used to cover the incision after the surgery. The transannular patch reduces the stenotic or restrictive disease of the pulmonary artery PA associated with other surgeries. However, the impairment or elimination of the pulmonary valve PV may result in significant regurgitation, and prior to the present invention, a subsequent open chest surgery to replace the pulmonary valve was often necessary. The transannular patch technique can result in pulmonary arteries with a wide range of different sizes and shapes (see Figures 3A-3D).

[0031] 4A-4F, in one exemplary embodiment, the expanded docking station 10 includes one or more sealing portions 410, a valve seat 18, and one or more retaining portions 414. The sealing portion 410 provides a seal between the docking station 10 and an inner surface 416 of the circulatory system. The valve seat 18 provides a support surface for implanting or deploying the valve 29 within the docking station 10 after the docking station 10 is implanted within the circulatory system. The retaining portion 414 helps retain the docking station 10 and the valve 29 at an implantation or deployment site within the circulatory system. The expanded docking station 10 and the valve 29 as described in various embodiments herein also represent various docking stations and / or valves that may be known or developed, for example, various different types of valves may be substituted for and / or used as the valve 29 within the various docking stations.

[0032] 4A-4D are schematic illustrations of an exemplary deployment of the docking station 10 and the valve 29 in the circulatory system. With reference to FIG. 4A, the docking station 10 is in a compressed form / configuration and is introduced to a deployment site in the circulatory system. For example, the docking station 10 can be positioned at a deployment site in the pulmonary artery by a catheter (e.g., catheter 3600 as shown in FIG. 50A-50D). With reference to FIG. 4B, the docking station 10 is expanded in the circulatory system such that the sealing portion 410 and the retaining portion 414 engage an inner surface 416 of a portion of the circulatory system. With reference to FIG. 4C, after the docking station 10 is deployed, the valve 29 is in a compressed form and is introduced to 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. In the example depicted herein, the docking station 10 is longer than the valve. However, in other embodiments, the docking station 10 can be the same length as or shorter than the valve 29. Similarly, the valve seat 18 can be longer, shorter, or the same length as the valve 29.

[0033] 4D, the valve 29 is expanded and supported by the docking station valve seat 18. The valve 29 only needs to expand into the narrow valve seat 18 rather than into a wider space in the portion of the circulatory system occupied by the docking station 10. The docking station 10 allows the valve 29 to operate within the expanded diameter range for which it is designed.

[0034] FIG. 4E illustrates that the cross-sectional size and / or shape of an inner surface 416 of a circulatory system, such as an inner surface of a cardiac vessel or anatomical structure, may vary along its length. In an exemplary embodiment, the docking station 10 is configured to expand radially outward to various degrees along its length L to conform to the shape of the inner surface 416. In an exemplary embodiment, the docking station 10 is configured such that the sealing portion 410 and / or the retaining portion engage the inner surface 416 despite the shape of the cardiac vessel or anatomical structure varying significantly along the length L of the docking station. The docking station can be made from highly resilient or malleable materials that accommodate large variations in anatomy. For example, the docking station can be made from highly flexible metals, metal alloys, polymers, or open-cell foams. Examples of metals and alloys that can be used include, but are not limited to, Nitinol, Elgiloy, and stainless steel, although other metals and highly resilient or malleable non-metallic materials can be used. For example, the docking station 10 can have a frame or portions of the frame (e.g., self-expanding frame, retention portion, sealing portion, valve seat, etc.) made from these materials, for example, shape memory materials such as Nitinol. These materials allow the frame to be compressed to a small size and then when the compressive force is released, the frame self-expands back to its pre-compression diameter.

[0035] One example of an open-cell foam that can be used to form the docking station or a portion of the docking station is a biocompatible foam such as polyurethane foam (e.g., as available from Biometrix, Rockville, Md.) The docking stations described herein can be self-expanding and / or expandable using an inflatable device to allow the docking station to engage an inner surface 416 having a variable shape.

[0036] FIGURE 4F illustrates the docking station 10 and valve 29 implanted in the pulmonary artery PA. As noted with respect to FIGURES 2A-2E and 3A-3D, the shape of the pulmonary artery can vary significantly along its length. In an exemplary embodiment, the docking station 10 is configured to conform to the changing shape of the pulmonary artery PA in the same manner as described with respect to FIGURE 4E.

[0037] 5A-5F, in one exemplary embodiment, the expandable docking station 10 is made from an expandable foam material, such as an open-cell biocompatible foam. An outer surface 510 of the foam material can serve as the sealing portion 410. In this example, the valve seat 18 can be provided on an inner surface 512 of the foam material as shown, or the inner surface 512 can serve as the valve seat. In the example shown by FIGS. 5A-5F, the retaining portion 414 is omitted, but a retaining portion can be used. In one embodiment, the foam material can be used with an expandable frame (e.g., metal, shape memory material, etc.). The foam material can cover or extend the entire length of the frame or only a portion of the length of the frame.

[0038] 5A-5D are schematic illustrations of the deployment of a foam docking station 10 and a valve 29 within a circulatory system. With reference to FIG. 5A, the docking station 10 is in a compressed form and introduced to a deployment site in the circulatory system. For example, the docking station 10 can be positioned at a deployment site in the pulmonary artery by a catheter (e.g., catheter 3600 shown in FIGS. 50A-50D). With reference to FIG. 5B, the docking station 10 is expanded within the circulatory system such that the sealing portion 410 engages an inner surface 416 of the circulatory system. With reference to FIG. 5C, after the docking station 10 is deployed, the valve 29 is in a compressed form and introduced to the valve seat 18 or inner surface 512 of the docking station 10. With reference to FIG. 5D, the valve 29 is expanded within the docking station such that the valve 29 engages the valve seat 18 or inner surface 512 (e.g., if the inner surface 512 acts as a valve seat).

[0039] 5E illustrates that the cross-section of an inner surface 416 of a circulatory system, such as the inner surface of a cardiac vessel or anatomical structure, may vary along its length. In one exemplary embodiment, the foam docking station 10 is configured to expand radially outward to varying degrees along its length L to conform to the shape of the inner surface 416.

[0040] FIGURE 5F illustrates foam docking station 10 and valve 29 implanted in the pulmonary artery PA. As noted with respect to FIGURES 2A-2E and 3A-3D, the shape of the pulmonary artery can vary significantly along its length. In an exemplary embodiment, docking station 10 is configured to conform to the changing shape of the pulmonary artery PA in the same or similar manner as described with respect to FIGURE 4E.

[0041] Referring to FIG. 6A, a docking station, such as that described with respect to FIGS. 4A-4D, is deployed in the pulmonary artery PA of the heart H. FIG. 6B shows the valve 29 deployed in the docking station 10 shown by FIG. 6A. In FIGS. 6A and 6B, the heart is in systole. FIG. 7A is an enlarged representation of the docking station 10 and the valve 29 in the pulmonary artery PA of FIG. 6B. When the heart is in systole, the valve 29 is open. Blood flows from the right ventricle RV through the pulmonary artery PA, the docking station 10, and the valve 29, as indicated by arrow 602. FIG. 7B shows a blood-filled space 608, which represents the valve 29 being open when the heart is in systole. FIG. 7B does not show the interface between the docking station 10 and the pulmonary artery to simplify the drawing. The hatched lines in FIG. 7B show blood flow through the open valve. In one exemplary embodiment, blood is prevented from flowing between the pulmonary artery PA and the docking station 10 by the sealing portion 410, and blood is prevented from flowing between the docking station 10 and the valve 29 by seating the valve 29 in the valve seat 18 of the docking station 10. In this example, blood substantially only flows or can only flow through the valve 29 when the heart is in systole.

[0042] Figure 8 shows the valve 29 shown by Figure 6B, the docking station 10, and the heart H when the heart is in diastole. With reference to Figures 9A and 9B, when the heart is in diastole, the valve 29 is closed. Figure 9A is an enlarged representation of the docking station 10 and the valve 29 in the pulmonary artery PA of Figure 8. Blood flow in the pulmonary artery PA above the valve 29 (i.e., in the pulmonary artery branch 760) is blocked by the valve 29 being closed, preventing blood flow as indicated by the arrows 900. The solid area 912 in Figure 9B represents the valve 29 being closed when the heart is in diastole.

[0043] In one exemplary embodiment, the docking station 10 acts as an isolator that prevents or substantially prevents the radially outward force of the valve 29 from being transferred to the circulatory system inner surface 416. In one embodiment, the docking station 10 includes a valve seat 18 (which is not expanded radially outward by the radially outward force of the THV or valve 29, or is not expanded radially outwardly substantially, i.e., the diameter of the valve seat is not increased or does not increase by more than 4 mm due to the force of the THV) and an anchoring / retaining portion 414 and a sealing portion 410 that impart a relatively small radially outward force 720, 722 (compared to the radially outward force applied to the valve seat 18 by the valve 29) against the circulatory system inner surface 416.

[0044] When a docking station is not used, the stent and frame of the THV are held in place within the circulatory system by a relatively high radially outward force 710 of the stent or frame 712 of the THV acting directly on the inner surface 416 of the circulatory system. When a docking station is used, as in the example shown by FIG. 7A, the stent or frame 712 of the valve 29 expands or is expanded radially outward to apply a large force 710 against the valve seat 18 of the docking station 10. This large radially outward force 710 secures the valve 29 to the valve seat 18 of the docking station 10. However, because the valve seat 18 is not expanded or substantially not expanded by the force 710, the force 710 is isolated from the circulatory system rather than being used to secure the docking station within the circulatory system.

[0045] In an exemplary embodiment, the radially outward force 722 of the sealing portion 410 against the inner surface 416 is substantially less than the radially outward force 710 exerted by the valve 29 against the valve seat 18. For example, the radially outward sealing force 722 can be less than ½ the radially outward force 710 exerted by the valve, less than ⅓ the radially outward force 710 exerted by the valve, less than ¼ the radially outward force 710 exerted by the valve, less than ⅛ the radially outward force 710 exerted by the valve, or even less than ⅓ the radially outward force 710 exerted by the valve. In an exemplary embodiment, the radially outward force 722 of the sealing portion 410 is selected to provide a seal between the inner surface 416 and the sealing portion 410, but is insufficient by itself to maintain the position of the valve 29 and docking station 10 within the circulatory system.

[0046] In one exemplary embodiment, the radially outward force 720 of the anchoring / retaining portion 414 against the inner surface 416 is substantially less than the radially outward force 710 exerted by the valve 29 against the valve seat 18. For example, the radially outward sealing force 720 can be less than ½ the radially outward force 710 exerted by the valve, less than ⅓ the radially outward force 710 exerted by the valve, less than ¼ the radially outward force 710 exerted by the valve, less than ⅛ the radially outward force 710 exerted by the valve, or even less than ⅓ the radially outward force 710 exerted by the valve.

[0047] In an exemplary embodiment, the radially outward force 720 of the retention portion 414 is insufficient by itself to retain the position of the valve 29 and docking station 10 within the circulatory system. Instead, the pressure of the blood 608 is used to enhance the retention of the retention portion 414 against the inner surface 416. Referring again to FIG. 6A, when the heart is in systole, the valve 29 is open and blood flows through the valve as indicated by the arrow 602. Because the valve 29 is open and blood flows through the valve 29, the pressure P exerted by the blood on the docking station 10 and valve 29 is low, as indicated by the small arrow P shown in FIG. 7A. Although the pressure P is low, it presses the docking station and its upper retention portion 414 against the surface 416 in the direction generally indicated by the arrow F. This blood flow assisted force F exerted by the retention portion 414 on the surface 416 prevents the docking station 10 and valve 29 from moving in the direction of blood flow 602 during systole of the heart H.

[0048] 9A, when the heart is in diastole, valve 29 is closed and blood flow is obstructed as indicated by arrow 900. Because valve 29 is closed and valve 29 and docking station 10 obstruct blood flow, the pressure P exerted by blood on docking station 10 and valve 29 is high as indicated by large arrow P in FIG. 9A. This high pressure P presses lower retention portion 414 against surface 416 generally in the direction indicated by large arrow F. This blood flow assisted force F exerted by retention portion 414 on surface 416 prevents docking station 10 and valve 29 from moving in the direction indicated by arrow 900.

[0049] Because the force exerted by the upper and lower retention portions 414 is determined by the amount of pressure exerted by the blood on the valve 29 and docking station 10, the force exerted on surface 416 is automatically proportional. That is, the upper retention portion presses against surface 416 with less force when the heart is in systole than the lower retention portion presses against surface 416 when the heart is in diastole. This is because the pressure on an open valve 29 and docking station 10 during systole is less than the pressure on a closed valve and docking station during diastole.

[0050] The valve seat 18 and sealing portion 410 can be in a wide variety of different configurations. For example, the valve seat 18 can be any structure that does not expand radially outward or does not expand substantially radially outward by the radially outward force of the THV (i.e., the diameter of the valve seat in the deployed position / configuration may not expand or may expand less than 4 mm, e.g., when a valve is deployed on the valve seat, the diameter may expand by 1-4 mm). For example, the valve seat 18 can include sutures or metal rings that resist or limit the expansion. However, in one embodiment, the valve seat 18 (or any valve seat described herein) can be expandable over a wider range, e.g., when a valve is deployed on the valve seat, the diameter may expand from 5 mm to 30 mm. In one embodiment, the diameter may expand from a diameter of 5 mm or 6 mm to a diameter of 20 mm to 29 mm, 24 mm, 26 mm, 29 mm, etc., or from different diameters within that range. Even if it is further expandable, the valve seat can remain limited in expansion, for example limited to avoid expanding beyond the expanded diameter of the valve placed on the valve seat, or beyond a diameter that holds the valve securely in the valve seat by forces generated between the valve and the valve seat. The valve seat 18 can be part of or define a portion of the body of the docking station 10, or the valve seat 18 can be a separate component that is attached to the body of the docking station. The valve seat 18 can be longer, shorter, or the same length as the valve. The valve seat 18 can be significantly shorter than the valve 29 when the valve seat 18 is defined by a suture or a metal ring. The valve seat 18 formed by a suture or a metal ring can form a narrow circumferential seal line between the valve 29 and the docking station.

[0051] The sealing portion 410 of various embodiments can be in a wide variety of different forms. For example, the sealing portion 410 can be any structure that provides a seal between the docking station 10 and a surface 416 of the circulatory system. For example, the sealing portion 410 can include fabric, foam, biocompatible tissue, an expandable metal frame, combinations thereof, and the like. The sealing portion 410 can be part of or define a portion of the body of the docking station 10 and / or the sealing portion 410 can be a separate component that is attached to the body of the docking station. The docking station 10 can include a single sealing portion 410, or two, or more than two sealing portions.

[0052] As discussed above, in one exemplary embodiment, the sealing portion 410 is configured to apply a small radially outward force to the surface 416. The small radially outward force can be applied in a variety of different ways. For example, the sealing portion can be made from a highly compressible or malleable material. With reference to FIG. 7C, in one exemplary embodiment, the body of the docking station 10 is made from an elastic or superelastic metal. One such metal is Nitinol. When the body of the docking station 10 is made from a lattice of metal compression members, the body can have spring properties. With reference to FIG. 7C, like a spring, when the body of the docking station is unconstrained and allowed to relax to its maximum diameter, the body of the docking station applies little or no radially outward force. As the body of the docking station 10 is compressed, like a spring, the radially outward force applied by the docking station increases. As shown by FIG. 7C, in an exemplary embodiment, the relationship between the radial outward force of the docking station body and the expanded diameter of the docking station is non-linear, although in an exemplary embodiment, the relationship can be linear. In the example shown by FIG. 7C, curve 750 illustrates the relationship between the radial outward force exerted by the docking station 10 and the compressed diameter of the docking station. In region 752, curve 750 has a small slope. In this region 752, the radial outward force is small and changes only a small amount. In an exemplary embodiment, region 752 corresponds to a diameter of 25 mm to 40 mm, such as 27 mm to 38 mm. The radial outward force is small but not zero in region 752. In region 754, curve 750 has a larger slope. In this region 754, the radial outward force increases significantly as the docking station is compressed. In an exemplary embodiment, the body of the stent is constructed to be in region 752 of small slope. This allows the sealing portion 710 to exert only a small radially outward force on the inner surface 416 of the circulatory system over a wide range of diameters.

[0053] The retaining portion 414 can be in a wide variety of different forms. For example, the retaining portion 414 can be any structure that sets the position of the docking station 10 within the circulatory system. For example, the retaining portion 414 can press against or into the inner surface 416 or extend around the anatomical structure of the circulatory system to set the position of the docking station 10. The retaining portion 414 can be part of or define a portion of the body of the docking station 10, or the retaining portion 414 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 414, or two, or more than two retaining portions.

[0054] 10A-10C show that the docking station 10 can have any combination of one or more different types of valve seat 18 and sealing portion 410. In the example shown by FIG. 10A, the valve seat 18 is a separate component attached to the body of the docking station 10, and the sealing portion is integrally formed with the body of the docking station. In the example shown by FIG. 10B, the valve seat 18 is a separate component attached to the body of the docking station 10, and the sealing portion 410 is a separate component attached to the body of the docking station. In the example shown by FIG. 10C, the valve seat 18 is integrally formed with the body of the docking station 10, and the sealing portion is integrally formed with the body of the docking station. In the example shown by FIG. 10D, the valve seat 18 is integrally formed with the body of the docking station 10, and the sealing portion is a separate component attached to the body of the docking station 10.

[0055] As mentioned above, the length of the pulmonary artery PA and other anatomical structures of the circulatory system can vary significantly from patient to patient. With reference to FIGS. 11A-11D, in one exemplary embodiment, the length of the docking station 10 is adjustable, as indicated by arrow 1100. This adjustability 1100 refers to the ability to adjust the post-implantation / post-expansion length of the docking station, rather than the inherent change in length that occurs when a stent expands from a compressed state to an expanded state. The length can be adjusted in a variety of different ways. In the example shown by FIGS. 11A-11D, the docking station 10 includes a first half 1102 and a second half 1104. As used herein, the use of the term "half" in reference to a two-part docking station is synonymous with "part" and does not require that the first and second halves or parts be equal in size, i.e., the first half may be larger / longer than the second half and vice versa. In one embodiment, the second half 1104 can be inserted or "snipped" into the first half 1102. The amount of insertion or "snipped" sets the length of the docking station 10. Any of the docking stations 10 shown and described in this patent application can be length adjustable by creating the docking station from two parts that are nested together or otherwise adjustable relative to one another. In one embodiment, the length of the single piece docking station can be foldable and expandable. In one embodiment, the docking station can be formed of a material that can change shape to adjust the length. In one embodiment, more than two parts (e.g., three, four, or more parts) can be combined in a similar manner and can include one or more features similar to the first half 1102 and the second half 1104.

[0056] In one exemplary embodiment, the length of the docking station 10 can be adjusted within the pulmonary artery PA by first deploying the first half 1102 of the docking station 10 within the pulmonary artery. For example, the first half 1102 can be positioned and expanded as desired, such as such that the distal end 1106 of the first half is aligned with or extends somewhat beyond a branch of the pulmonary artery. After the first half 1102 is expanded within the pulmonary artery, the compressed second half 1104 can be positioned such that the distal end 1110 is disposed at the proximal end 1108 of the first half 1102. In one embodiment, the position of the second half 1104 is selected such that the sealing portion 410 and the retention portion 414 contact the pulmonary artery and set the position of the docking station 10 within the pulmonary artery. Once properly positioned, the second half 1104 is expanded. In one embodiment, the distal end 1110 of the second half 1104 frictionally engages the proximal end 1108 of the first half to secure the two halves 1102, 1104 together. In one embodiment, locks, locking mechanisms, sutures, crosses, links, and / or other attachment devices / mechanisms can be used to help secure the halves / portions together.

[0057] In the example shown by Figures 11A-11D, the valve seat 18 and the sealing portion 410 are included on the second half 1104 of the docking station 10. However, in other embodiments, the valve seat 18 and / or the sealing portion 410 can be included on the first half 1102. Figures 11A-11C show that the halves 1102, 1104 of the docking station 10 can have any combination of different types of valve seats 18 and sealing portions 410. In the example shown by Figure 11A, the valve seat 18 is a separate component attached to the body of the docking station half 1104, and the sealing portion is integrally formed with the body of the docking station half 1104. In the example shown by Figure 11B, the valve seat 18 is a separate component attached to the body of the docking station half 1104, and the sealing portion 410 is a separate component attached to the body of the docking station half 1104. 11C, the valve seat 18 is integrally formed with the body of the docking station half 1104, and the sealing portion is integrally formed with the body of the docking station half 1104. In the example shown by FIG. 11D, the valve seat 18 is integrally formed with the body of the docking station half 1104, and the sealing portion 410 is a separate component that is attached to the body of the docking station half 1104.

[0058] 12A-12D show an exemplary embodiment of a docking station 10 having two sealing portions 410. The docking station 10 can have any combination of one or more different types of valve seat 18 and sealing portion 410. In the example shown by FIG. 12A, the valve seat 18 is a separate component attached to the body of the docking station 10, and the sealing portion 410 is integrally formed with the body of the docking station. In the example shown by FIG. 12B, the valve seat 18 is a separate component attached to the body of the docking station 10, and the sealing portion 410 is a separate component attached to the body of the docking station. In the example shown by FIG. 12C, the valve seat 18 is integrally formed with the body of the docking station 10, and the sealing portion is integrally formed with the body of the docking station. In the example shown by FIG. 12D, the valve seat 18 is integrally formed with the body of the docking station 10, and the sealing portion is a separate component attached to the body of the docking station 10.

[0059] 13A-13D show that the docking station shown by FIGS. 12A-12D can be a two-piece nested docking station. The pieces 1102, 1104 of the docking station 10 can have any combination of one or more different types of valve seat 18 and sealing portion 410 in either or both of the two pieces. In the example shown by FIG. 13A, the first half 1102 includes an integral sealing portion 410. The second half 1104 includes the valve seat 18, which is a separate component attached to the body of the docking station 10, and the sealing portion 410 is integrally formed with the body of the docking station. In the example shown by FIG. 13B, the first half 1102 includes a sealing portion 410 that is separate from the body of the first half 102. The valve seat 18 is a separate component attached to the body of the docking station 10, and the sealing portion 410 is a separate component attached to the body of the docking station. In the example shown by FIG. 13C, the first half 1102 includes an integral sealing portion 410. The valve seat 18 is integrally formed with the body of the second half 1104 of the docking station 10, and the sealing portion 410 is integrally formed with the body of the second half 1104. In the example shown by FIG. 13D, the first half 1102 includes a sealing portion 410 that is separate from the body of the first half 102. The valve seat 18 is integrally formed with the body of the second half 1104 of the docking station 10, and the sealing portion 410 is a separate component attached to the body of the second half 1104.

[0060] 14A-14G, in an exemplary embodiment, the docking station 10 can include a permeable portion 1400 through which blood can flow as indicated by arrow 1402, and an impermeable portion 1404 through which blood cannot flow. In an exemplary embodiment, the impermeable portion 1404 extends from at least the sealing portion 410 to the valve seat 18 to prevent blood from flowing around the valve 29. In an exemplary embodiment, because blood can flow freely through the permeable portion 1400, a portion of the docking station that does not seal against the inner surface 416 of the circulatory system or that seals against the valve 29 does not impede the flow of blood. For example, the docking station 10 can extend into a branch of the pulmonary artery, and the portion 1400 of the docking station 10 that extends into the pulmonary artery allows blood to flow freely through the docking station 10. In one exemplary embodiment, blood is able to flow freely through the transparent portion 1400, so that as the heart beats, the area 1420 between the docking station and the circulatory system is flushed with blood, thereby preventing blood from stagnating in the area 1420.

[0061] The impermeable portion 1404 can be in a wide variety of different forms. The impermeable portion 1404 can be any structure or material that prevents blood from flowing through the impermeable portion 1404. For example, the body of the docking station 10 can be formed from a wire or lattice, such as a Nitinol wire or lattice, and the cells of the body are covered with an impermeable material (see FIG. 18). A wide variety of different materials can be used as the impermeable material. For example, the impermeable material can be a blood-impermeable fabric, such as a PET fabric, or a biocompatible covering material, such as a fabric treated with a blood-impermeable coating, polyester, or an engineered biomaterial, such as pericardium.

[0062] 14A-14G show that a wide variety of docking station configurations can include a permeable portion 1400. The sealing portion 410 can be integrally formed with the body of the docking station as shown by FIGS. 14B, 14D, and 14F, or can be separate as shown by FIGS. 14C, 14E, and 14G. In FIGS. 14F and 14G, the docking station 10 includes portions 1410. These portions 1410 are similar to the sealing portion 410, but since the portions 1410 are part of the permeable portion 1400, no seal is formed with the inner surface 416 of the circulatory system. The valve seat 18 can be separate from the body of the docking station as shown by FIGS. 14A-14C, or can be integrally formed with the body of the docking station 10 as shown in FIGS. 14D-14G.

[0063] 15A, 15B, 16, 17A, and 17B show an exemplary embodiment of a frame 1500 or body of the docking station 10. The frame 1500 or body can be in a wide variety of different forms, and FIGS. 15A, 15B, 16, 17A, and 17B show only one of many possible configurations. In the example shown by FIGS. 15A, 15B, 16, 17A, 17B, and 18, the docking station 10 has a relatively wide proximal inflow end 12 and a distal outflow end 14, and a relatively narrow portion 16 that forms a valve seat 18 between the ends 12, 14. In the example shown by FIGS. 15A, 15B, 17A, and 17B, the frame 1500 of the docking station 10 is preferably a wide stent made up of a plurality of metal struts 1502 that form cells 1504. 15A, 15B, 17A, and 17B, the frame 1500 has a generally hourglass shape with a narrow portion 16 between the proximal and distal ends 12, 14 that, when covered by an impermeable material, forms a valve seat 18. As will be described below, the valve 29 expands within the narrow portion 16, thereby forming the valve seat 18.

[0064] 15A, 15B, 17A, and 17B show the frame 1500 in an unconstrained expanded state. In this exemplary embodiment, the retaining portion 414 includes ends or apexes 1510 of the metal compression members 1502 at the proximal end 12 and the distal end 14. The sealing portion 410 is between the retaining portion 414 and the waist 16. In the unconstrained state, the retaining portion 414 extends generally radially outward and is radially outward of the sealing portion 410. FIG. 16 shows the frame in a compressed state for delivery and expansion by a catheter. The docking station can be made from highly elastic or malleable materials that accommodate large variations in anatomy. For example, the docking station can be made from highly flexible metals, alloys, polymers, or open-cell foams. One example of a highly elastic metal is Nitinol, but other metals and non-metallic highly elastic or malleable materials can be used. The docking station 10 can be self-expanding, manually expandable (eg, balloon expandable), or mechanically expandable. A self-expanding docking station 10 can be made of a shape memory material, such as, for example, Nitinol.

[0065] FIG. 18 shows a frame 1500 including an impermeable material 21 attached to the frame 1500 to form the docking station 10. Referring to FIG. 18, in one exemplary embodiment, a band 20 extends around or is integral with the waist or narrow portion 16 to form a non-expandable or substantially non-expandable valve seat 18. The band 20 reinforces the waist, and once the docking station is deployed and expanded, the waist / valve seat is relatively non-expandable in its deployed configuration. In the example shown by FIG. 19, the valve 29 is secured by its collapsible frame expanding into the narrow portion 16 to form the valve seat 18 of the docking station 10. As mentioned above, the non-expandable or substantially non-expandable valve seat 18 prevents the radially outward force of the valve 29 from being transferred to the inner surface 416 of the circulatory system. However, in another exemplary embodiment, the waist / valve seat of the deployed docking station can optionally be slightly elastically expandable when the valve is deployed thereagainst. This optional elastic expansion of the waist / valve seat 18 can provide pressure on the valve 29 to help hold the valve 29 in place within the docking station.

[0066] The bands can be in a wide variety of different forms and can be made from a wide variety of different materials. The bands 20 can be made of PET, one or more sutures, fabric, metal, polymer, biocompatible tape, or other relatively inexpandable materials known in the art sufficient to maintain the shape of the valve seat 18 and hold the valve 29 in place. The bands can extend around the exterior of the stent or can be an integral part of it, such as when fabric or another material is interwoven into or through the cells of the stent. The bands 20 can be narrow, such as the suture bands of FIG. 18, or wide. The bands can be of various widths, lengths, and thicknesses. In one non-limiting example, the valve seat 18 is 27-28 mm wide, but the diameter of the valve seat should be within the operating range of the particular valve 29 secured within the valve seat 18 and may differ from the examples discussed above. The valve 29 can optionally be slightly expanded around either side of the valve seat when placed into the docking station. This aspect is sometimes referred to as a "dog bone" (eg, due to the shape it forms around the valve seat or band) and may also help hold the valve in place.

[0067] 20 and 21 show the docking station 10 of FIG. 18 implanted in a circulatory system, such as the pulmonary artery. The sealing portion 410 provides a seal between the docking station 10 and an inner surface 416 of the circulatory system. In the example of FIGS. 20 and 21, the sealing portion 410 is formed by providing an impermeable material 21 (see FIG. 21) on the frame 1500 or a portion thereof. In particular, the sealing portion 410 can comprise a rounded radially outwardly extending portion 2000 on the underside of the frame 1500. In an exemplary embodiment, the impermeable material 21 extends from at least the portion 2000 of the frame 1500 to the valve seat 18. This makes the docking station impermeable from the sealing portion 410 to the valve seat 18. As such, all blood flowing in the direction of the inflow end 12 toward the outflow end 14 is directed to the valve seat 18 (and to the valve 29 when loaded or deployed into the valve seat).

[0068] In a preferred embodiment of the docking station 10, the inflow section has blood impermeable walls, while the outflow section has relatively open walls. In one approach, the inflow end section 12, the middle section 16, and a portion of the outflow end section 14 are covered with a blood impermeable fabric 21 that can be sewn onto the stent or attached in another manner known in the art. The impermeability of the inflow section of the stent helps direct blood into the docking station 10 and ultimately through a valve that is expanded and secured within the docking station 10.

[0069] From another perspective, this embodiment of the docking station is designed to seal at the proximal inflow section 2000 to create a conduit for blood flow. However, the distal outflow section remains substantially open, which allows the docking station 10 to be placed high in the pulmonary artery without restricting blood flow. For example, the permeable portion 1400 can extend into a branch of the pulmonary artery and not impede or significantly impede blood from flowing beyond the branch. In one embodiment, a blood impermeable fabric, such as a PET fabric, or other material, covers the proximal inflow section, but the covering does not cover any part or at least a portion of the distal outflow section 14. As one non-limiting example, when the docking station 10 is placed in the pulmonary artery, a large blood vessel, a significant amount of blood flowing through the artery is forced by the impermeable material 21 into the valve 29. Because the fabric 21 is fluid impermeable, blood cannot pass through. Again, a variety of other biocompatible covering materials can be used, such as, for example, foams or fabrics that have been treated with a blood impermeable coating, polyester, or engineered biomaterials such as pericardium.

[0070] In the example shown by FIG. 21, more docking station frames 1500 are provided with impermeable material 21 to form a relatively large impermeable portion 1404. In the example shown by FIG. 21, the impermeable portion 1404 extends from the inflow end 12 and terminates at a row of cells 1504 before the outflow end. Thus, the distalmost row of cells 1504 forms the permeable portion 1400. However, more rows of cells 1504 can be left uncoated with the impermeable material to form a larger permeable portion. The permeable portion 1400 allows blood to pass in and out of the region 2130, as indicated by arrows 2132. That is, in one exemplary embodiment, blood can pass in and out of the region 2100.

[0071] The valve seat 18 can provide a support surface for embedding or deploying the valve 29 within the docking station 10. The retention portion 414 can retain the docking station 10 at an implantation or deployment site within the circulatory system. The retention portion shown has an outwardly curved flare that helps secure the docking station 10 within the artery. "Outward" as used herein means extending in a direction away from the central longitudinal axis of the docking station. As can be seen in FIG. 20, when the docking station 10 is compressed by the inner surface 416, the retention portion 414 engages the surface 416 at an angle α (from a normal to the surface of the retention portion 414 to a tangent to a center point at the surface), which can be 30-60 degrees, such as about 45 degrees, rather than extending substantially radially outward (i.e., α is 0-20 degrees or about 10 degrees) as in the uncompressed state (see FIG. 15B). This inward bending of the retention portion 414 as indicated by arrow 2020 acts to retain the docking station 10 within the circulatory system. The retention portion 414 is at the wider inflow end portion 12 and outflow end portion 14 and presses against the inner surface 416. The flared retention portion 414 engages within the surrounding anatomical structures within the circulatory system, such as the pulmonary artery space. In an exemplary embodiment, the flare serves as a stop to lock the device in place. When an axial force is applied to the docking station 10, the force forces the flared retention portion 414 into the surrounding tissue to resist stent migration as described in more detail below. In certain embodiments, the docking station has a generally hourglass shape with wider distal and proximal end portions with flared retention portions and a narrower band-like waist between the ends in which the valve is expanded.

[0072] 22 illustrates the docking station 10 deployed within the circulatory system and the valve 29 deployed within the docking station 10. After the docking station 10 is deployed, the valve 29 is in a compressed form and is introduced into the valve seat 18 of the docking station 10. The valve 29 is expanded within the docking station such that the valve 29 engages the valve seat 18. In the example illustrated by FIG. 22, the docking station 10 is longer than the valve. However, in one embodiment, the docking station 10 may be the same length as the valve 29 or shorter.

[0073] The valve 29 can be delivered to the site of the docking station via conventional means, such as by balloon or mechanical expansion, or by self-expansion. Once expanded, the valve 29 fits into a valve seat in the docking station 10. In one embodiment, the band-like waist is slightly elastic and exerts an elastic force against the valve 29 to help hold the THV in place.

[0074] Figures 23A and 23B illustrate that the docking station 10 can be used to implant a valve 29 having a certain size to accommodate a variety of different sizes of circulatory system anatomies. In the example of Figures 23A and 23B, the same sized docking station 10 is deployed in two different sized vessels 2300, 2302, such as two different sized pulmonary arteries PA. In that example, the vessel 2300 shown by Figure 23A has a larger effective diameter than the vessel 2302 shown by Figure 23B. (Note that in this patent application, the size of circulatory anatomical structures is referred to by the terms "diameter" or "effective diameter". Circulatory anatomical structures are often not circular. The terms "diameter" and "effective diameter" herein refer to the diameter of a circle or disk that can be deformed to fit within a non-circular anatomical structure.) In the example shown by Figs. 23A and 23B, the sealing portion 410 and the retaining portion 414 are adapted to contact each vessel 2300, 2302. However, the valve seat 18 remains the same size even when the sealing portion 410 and the retaining portion 414 are compressed. In this manner, the docking station 10 accommodates a wide variety of different anatomical sizes for implanting a standard or single size valve. For example, the docking station can accommodate vessel diameters of 25 mm to 40 mm, such as 27 mm to 38 mm, and provide a valve seat of a constant or substantially constant diameter of 24 mm to 30 mm, such as 27 mm to 28 mm. However, the valve seat 18 can be adapted for applications where the vessel diameter is larger or smaller than 25 mm to 40 mm, providing a valve seat larger or smaller than 24 mm to 30 mm.

[0075] 23A and 23B, the band 20 maintains a constant or substantially constant diameter of the valve seat 18 even as the proximal and distal ends of the docking station expand to the respective diameters required to engage the inner surface 416. Although the diameter of the pulmonary artery PA can vary significantly from patient to patient, the valve seat 18 in the deployed configuration consistently has a diameter within the acceptable range for the valve 29.

[0076] 24 and 25 show cross-sections of the docking station 10 shown by FIG. 18 when implanted in vessels 2300, 2302 of different sizes of the circulatory system, with a transcatheter heart valve 29, shown diagrammatically as having the same size, being loaded or deployed in each docking station 10. In this example, the docking station 10 conforms to the vessels 2300, 2302 having various different sizes and acts as an isolator that prevents or substantially prevents the radially outward force of the valve 29 from being transferred to the vessels. The valve seat 18 is not radially outwardly expanded or is not substantially radially outwardly expanded by the radially outward force of the valve 29, and the anchoring / retention portion 414 and the sealing portion 410 exert only a relatively small radially outward force (compared to the radially outward force exerted by the valve 29 on the valve seat 18) on the vessels 2300, 2302, even when the docking station is deployed in a vessel 2302 having a smaller diameter.

[0077] 24 and 25, the stent or frame 712 of the valve 29 expands or is expanded radially outward to apply a large force 710 against the valve seat 18 of the docking station 10. This large radially outward force 710 secures the valve 29 to the valve seat 18 of the docking station 10. However, because the valve seat 18 is not expanded or substantially not expanded by the force 710, the force 710 is not used to secure the docking station within the circulatory system, but rather is isolated from the circulatory system.

[0078] In an exemplary embodiment, the radially outward force 722 of the sealing portion 410 against both the larger vessel 2300 and the smaller vessel is substantially less than the radially outward force 710 exerted by the valve 29 against the valve seat 18. For example, for the smallest vessel accommodated by the docking station 10 for implanting the valve, the radially outward sealing force 722 can be less than ½ the radially outward force 710 exerted by the valve, less than ⅓ the radially outward force 710 exerted by the valve, less than ¼ the radially outward force 710 exerted by the valve, less than ⅛ the radially outward force 710 exerted by the valve, or even less than ⅓ the radially outward force 710 exerted by the valve. In an exemplary embodiment, the radially outward force 722 of the sealing portion 410 is selected to provide a seal between the inner surface 416 and the sealing portion 410, but is insufficient by itself to maintain the position of the valve 29 and docking station 10 within the circulatory system. In one embodiment, the outward radial force 722 is sufficient to maintain the position of the valve 29 and docking station 10 within the circulatory system.

[0079] In one exemplary embodiment, the docking station 10 shown by Fig. 18 also includes an anchoring / retention portion 414 that exerts a radially outward force 720 that is substantially less than the radially outward force 710 exerted by the valve 29 against the valve seat 18. For example, for the smallest vessel accommodated by the docking station 10 for implanting the valve, the radially outward sealing force 720 can be less than 1 / 2 the radially outward force 710 exerted by the valve, less than 1 / 3 the radially outward force 710 exerted by the valve, less than 1 / 4 the radially outward force 710 exerted by the valve, less than 1 / 8, or even less than 1 / 10 the radially outward force 710 exerted by the valve. In one embodiment, the radially outward force 720 of the anchoring / retention portion 414 is insufficient by itself to retain the position of the valve 29 and docking station 10 within the circulatory system. In one embodiment, the outward radial force 720 is sufficient to maintain the position of the valve 29 and docking station 10 within the circulatory system.

[0080] In an exemplary embodiment, the frame 1500 of the docking station 10 is made from an elastic or superelastic material or metal. One such metal is Nitinol. When the frame 1500 of the docking station 10 is made from a lattice of metal compression members, the body can have the properties of a spring. Referring to FIG. 7C, like a spring, when the frame 1500 of the docking station 10 shown by FIG. 24 and FIG. 25 is unconstrained and allowed to relax to its maximum diameter, the frame of the docking station exerts little or no radial outward force. As the frame 1500 of the docking station 10 is compressed, like a spring, the radial outward force exerted by the docking station increases. As shown by FIG. 7C, in an exemplary embodiment, the relationship between the radial outward force of the docking station frame 1500 and the expanded diameter of the docking station is nonlinear, but can also be linear. In the example shown by FIG. 7C, curve 750 illustrates the relationship between the outward radial force exerted by docking station 10 and the compressed diameter of the docking station. In region 752, curve 750 has a small slope. In this region 752, the outward radial force is small and changes only a small amount. In an exemplary embodiment, region 752 corresponds to a diameter of 25 mm to 40 mm, such as 27 mm to 38 mm. The outward radial force is small but not zero in region 752. In region 754, curve 750 has a larger slope. In this region 754, the outward radial force increases significantly as the docking station is compressed. In an exemplary embodiment, the body of the stent is constructed to be in the region 752 of small slope in both the largest vessel 2300 (FIG. 24) and the smallest vessel 2302 (FIG. 25) accommodated by docking station 10. This allows the sealing portion 410 to exert only a small radially outward force on the inner surface 416 of the circulatory system over a wide range of diameters.

[0081] 26A-26C show the docking station 10 of FIG. 18 implanted in the pulmonary artery. FIG. 26A shows a profile of the docking station 10 implanted in the pulmonary artery PA. FIG. 26B shows a profile of the docking station 10 implanted in the pulmonary artery PA with a valve 29, shown diagrammatically, loaded or deployed in the docking station 10. FIG. 26C shows the docking station 10 and valve 29 as shown in FIG. 22 implanted in the pulmonary artery PA. As mentioned with respect to FIGS. 2A-2E and 3A-3D, the shape of the pulmonary artery can vary significantly along its length. In an exemplary embodiment, the docking station 10 is configured to conform to the changing shape of the pulmonary artery PA. The docking station 10 is shown as being positioned below a bifurcation or branch of the pulmonary artery. However, the docking station 10 is often positioned such that the end 14 extends into the pulmonary artery bifurcation 210. If it is envisioned that the docking station 10 extends into the pulmonary artery bifurcation, the docking station 10 may have a blood-permeable portion 1400 (eg, as shown in FIG. 21).

[0082] FIG. 27 illustrates another exemplary embodiment of the docking station 10. The docking station 10 includes a frame 2700 and an outer sealing portion 410. The frame 2700 or body can be in a wide variety of different forms, and FIG. 27 illustrates only one of many possible configurations. In the example illustrated by FIG. 27, the docking station 10 has a relatively wide proximal inflow end 12 and a distal outflow end 14, and an elongated, relatively narrow portion 2716. The valve seat 18 and sealing portion 410 can be provided anywhere along the length of the elongated, relatively narrow portion 2716. In the example illustrated by FIG. 27, the frame 2700 of the docking station 10 is preferably a stent made up of a plurality of metal struts 1502 forming cells 1504. The frame 2700 or portions of the frame can optionally be covered with an impermeable material 21 (e.g., as shown in FIG. 18).

[0083] 27 illustrates the frame 2700 and sealing portion 410 in an unconstrained expanded state / configuration or post-deployment configuration. In this exemplary embodiment, the retaining portion 414 comprises ends or apexes 1510 of the metal struts 1502 at the proximal end 12 and distal end 14. The sealing portion 410 can be a separate component disposed about the frame 2700 between the retaining portions 414. In the unconstrained state, the retaining portions 414 extend generally radially outward and can be radially outward of the sealing portions 410.

[0084] The docking station 10 shown by FIG. 27 can be made from highly resilient or malleable materials that accommodate large variations in anatomy. For example, the docking station can be made from highly flexible metal (e.g., the frame of the example of FIG. 27) as well as fabric and / or open-cell foam (e.g., the sealing portion of the example of FIG. 27). One example of a highly resilient metal is Nitinol, but other metals and highly resilient or malleable non-metallic materials can be used. One example of an open-cell foam that can be used is a biocompatible foam such as polyurethane foam (e.g., as available from Biometrix, Rockville, MD). In one embodiment, the foam that forms the sealing portion can also form a valve seat on its inner surface.

[0085] 27, the frame 2700 and / or separate sealing portion 410 can include optional bands 20 to form a non-expandable or substantially non-expandable valve seat 18. In another exemplary embodiment, the frame 2700 can be configured to be substantially non-expandable in the area of ​​the valve seat 18 without the use of bands 20. The optional bands 20 reinforce the frame 2700 and / or sealing portion, making the valve seat relatively non-expandable.

[0086] Optional band 20 can be in a wide variety of different forms and can be made from a wide variety of different materials and can be the same or similar to bands discussed elsewhere in this disclosure. Band 20 can be made of PET, one or more sutures, fabric, metal, polymer, biocompatible tape, or other relatively inexpandable material known in the art sufficient to maintain the shape of valve seat 18 and hold valve 29 in place. Band can extend around the exterior of the stent or can be an integral part thereof, such as when fabric or another material is interwoven into or through the cells of the stent. Band 20 can be narrow, such as the suture band in FIG. 18, or can be wide, as shown by the dashed lines in FIG. 27. In one non-limiting example, valve seat 18 is 27-28 mm in diameter, but the diameter of the valve seat should be within the operating range of the particular valve 29 secured within valve seat 18 and can be different from the examples discussed above.

[0087] 28 and 29 show a modification of the docking station 10 shown by FIG. 27 that is expandable in length. As mentioned above, the length of the pulmonary artery PA and other anatomical structures of the circulatory system can vary significantly from patient to patient. Referring to FIG. 29, in an exemplary embodiment, the length of the docking station 10 is adjustable, as indicated by arrow 1100. The length can be adjusted in a variety of different ways, for example, adjustable in any of the ways described elsewhere in this disclosure. In the example shown by FIG. 28 and 29, the docking station 10 includes a first half 1102 and a second half 1104. The second half 1104 can be inserted or "snipped" into the first half 1102. The amount of insertion or "snipping" sets the length of the docking station 10.

[0088] In an exemplary embodiment, the length of the docking station 10 is adjusted within the pulmonary artery PA by first deploying the first half 1102 of the docking station 10 within the pulmonary artery. For example, the first half 1102 can be positioned and expanded such that the distal end 1106 of the first half is aligned with or extends somewhat beyond a branch of the pulmonary artery. After the first half 1102 is expanded within the pulmonary artery, the compressed second half 1104 is positioned such that the distal end 1110 is disposed at the proximal end 1108 of the first half 1102. The position of the second half 1104 is selected such that the sealing portion 410 and the retention portion 414 contact the pulmonary artery and set the position of the docking station 10 within the pulmonary artery. Once properly positioned, the second half 1104 is expanded. The distal end 1110 of the second half 1104 frictionally engages the proximal end 1108 of the first half to secure the two halves 1102, 1104 together. In one embodiment, locks, locking mechanisms, sutures, crosses, links, and / or other attachment devices / mechanisms can be used (additionally or alternatively) to secure the two halves together.

[0089] 28 and 29, the valve seat 18 and the sealing portion 410 are included on the first half 1102 of the docking station 10. However, in other embodiments, the valve seat 18 and / or the sealing portion 410 may be included on the second half 1104 or in different locations on the first half and / or second half.

[0090] 30 and 31A show the docking station 10 of FIG. 27 of FIG. 28 and 29 implanted in a circulatory system, such as the pulmonary artery PA. The sealing portion 410 provides a seal between the docking station 10 and the inner surface 416 of the pulmonary artery PA. In the example of FIG. 30 and 31A, the sealing portion 410 is an expandable material, such as an expandable open-cell foam, on the frame 2700. In an exemplary embodiment, the sealing portion 410 coincides with or at least overlaps the valve seat 18. If the sealing portion 410 does not overlap the valve seat 18, an impermeable material 21 can be provided on a portion of the frame (e.g., from the sealing portion 410 to the valve seat 18 to make the docking station impermeable from the sealing portion 410 to the valve seat 18). Regardless of whether the sealing portion 410 overlaps the valve seat 18 or whether an impermeable material is provided from the sealing portion 410 to the valve seat 18, all blood flowing in a direction from the inflow end 12 toward the outflow end 14 is directed to the valve seat 18 (and to the valve 29 when loaded or deployed into the valve seat).

[0091] In one exemplary embodiment of the docking station 10, at least the outflow portion 14 of the frame 2700 is relatively open. With reference to FIG. 31A, this allows the docking station 10 to be placed high within the pulmonary artery without restricting blood flow. For example, the open cells 1504 may extend into a branch or bifurcation of the pulmonary artery, but do not impede or significantly impede blood from flowing beyond the branch. The open cells 1504 allow blood to flow through the frame 1500, as shown by the arrows 3132 in FIG. 31A.

[0092] In the example shown by FIG. 30 and FIG. 31A, the docking station 10 is retained within the pulmonary artery PA by expanding one or more of the retaining portions 414 radially outward into the region 210, 212 of the pulmonary artery PA where the inner surface 416 also extends outward. For example, the retaining portions 414 can be configured to extend radially outward into the pulmonary artery bifurcation 210 and / or the opening 212 of the pulmonary artery to the right ventricle RV. In an exemplary embodiment, the docking station 10 can be an adjustable docking station. For example, the docking station 10 can be a nested docking station as shown by FIG. 28, where the first portion 1102 is deployed such that the retaining portion 414 extends radially outward into the pulmonary artery bifurcation 210. The second portion 1104 can then be positioned within the first portion 1102 such that the retaining portion 414 coincides with the opening of the pulmonary artery or another outwardly extending region of the pulmonary artery. Once in place, the second portion 1104 can be expanded to secure the second section 1104 relative to the first section 1102 and to secure the second section relative to the pulmonary artery at the opening 212 or other outwardly extending area.

[0093] Referring to FIG. 31B, the valve seat 18 provides a support surface for loading or deploying the valve 29 into the docking station 10. The valve can be loaded or deployed into the valve seat using steps disclosed here or elsewhere in this disclosure. The anchoring / retention portion 414 retains the docking station 10 at the implantation or deployment site / location within the circulatory system. After the docking station 10 is deployed, the valve 29 is in a compressed form and can be introduced into the valve seat 18 of the docking station 10. The valve 29 can be expanded within the docking station so that the valve 29 engages the valve seat 18. The valve 29 can be delivered to the docking station site via conventional means, such as by balloon or mechanical expansion, or by self-expansion. When the valve 29 is expanded, it fits into the valve seat of the docking station 10.

[0094] Referring to FIG. 32A, the docking station shown in FIG. 18 is deployed in the pulmonary artery PA of the heart H. FIG. 32B shows the valve 29, shown generally, deployed in the docking station 10 shown in FIG. 32A. In FIGS. 32A and 32B, the heart is in systole. FIG. 33A is an enlarged representation of the docking station 10 and the valve 29 in the pulmonary artery PA of FIG. 32B. When the heart is in systole, the valve 29 is open. Blood flows from the right ventricle RV through the pulmonary artery PA, the docking station 10, and the valve 29, as indicated by arrow 3202. FIG. 33B shows the space 3208, which represents the valve 29 being open when the heart is in systole. FIG. 33B does not show the interface between the docking station 10 and the pulmonary artery for simplicity of illustration. The hatched lines in FIG. 33B show blood flow through the open valve. In one exemplary embodiment, blood is prevented from flowing between the pulmonary artery PA and the docking station 10 by the sealing portion 410, and blood is prevented from flowing between the docking station 10 and the valve 29 by seating the valve 29 in the valve seat 18 of the docking station 10. In this example, blood substantially only flows or can only flow through the valve 29 when the heart is in systole.

[0095] Figure 34 shows the valve 29 shown by Figure 32B, the docking station 10, and the heart H when the heart is in diastole. Referring to Figure 34, when the heart is in diastole, the valve 29 is closed. Figure 35A is an enlarged representation of the docking station 10 and the valve 29 in the pulmonary artery PA of Figure 34. Blood flow in the pulmonary artery PA above the valve 29 (i.e., in the pulmonary artery branch 210) is blocked by the valve 29 being closed, blocking blood flow as indicated by the arrows 3400. The solid area 3512 in Figure 35B represents the valve 29 being closed when the heart is in diastole.

[0096] 33A , the radially outward force 720 of the anchoring / retaining portion 414 against the inner surface 416 is substantially less than the radially outward force 710 exerted by the valve 29 against the valve seat 18. For example, the radially outward sealing force 720 can be less than ½ the radially outward force 710 exerted by the valve, less than ⅓ the radially outward force 710 exerted by the valve, less than ¼ the radially outward force 710 exerted by the valve, less than ⅛ the radially outward force 710 exerted by the valve, or even less than ⅓ the radially outward force 710 exerted by the valve.

[0097] 33A and 35A, in one exemplary embodiment, the radially outward force 720 of the retention portion 414 is insufficient by itself to retain the position of the valve 29 and the docking station 10 within the circulatory system. Instead, the pressure of the blood in the space 3208 is used to enhance the retention of the retention portion 414 against the inner surface 416. Referring again to FIG. 33A, when the heart is in systole, the valve 29 opens and blood flows through the valve as shown by the arrow 3202. Because the valve 29 is open and blood flows through the valve 29, the pressure P exerted by the blood on the docking station 10 and the valve 29 is low, as shown by the small arrow P shown in FIG. 33A. Although the pressure P is low, it presses the docking station and its upper retention portion 414 against the surface 416 in the general direction shown by the arrow F (the small F represents a relatively small force). This blood flow assisted force F exerted by the retaining portion 414 on the surface 416 prevents the docking station 10 and the valve 29 from moving in the direction of blood flow 3202 during systole of the heart H.

[0098] Referring to Fig. 35A, when the heart is in diastole, valve 29 is closed and blood flow is inhibited as shown by arrow 3400. Because valve 29 is closed and valve 29 and docking station 10 inhibit blood flow, the pressure P exerted by blood on docking station 10 and valve 29 is high as shown by large arrow P in Fig. 35A. This high pressure P presses lower retention portion 414 against surface 416 generally in the direction shown by large arrow F (large F represents a relatively large force). This blood flow assisted force F exerted by retention portion 414 on surface 416 prevents docking station 10 and valve 29 from moving in the direction shown by arrow 3400.

[0099] 33A and 35A, because the force exerted by the upper and lower retention portions 414 is determined by the amount of pressure exerted by the blood on the valve 29 and docking station 10, the force exerted on surface 416 is automatically proportional. That is, the force exerted by the upper retention portion against surface 416 when the heart is in systole is less than the force exerted by the lower retention portion against surface 416 when the heart is in diastole. This is because the pressure on the open valve 29 and docking station 10 during systole is less than the pressure on the closed valve and docking station during diastole.

[0100] A method of treating a subject (e.g., a method of treating a heart valve dysfunction / regurgitation / etc.) can include various steps, such as steps associated with introducing and deploying a docking station to a desired location / treatment area and introducing and deploying a valve into the docking station. For example, FIG. 36A shows the docking station shown by FIG. 18 being deployed by a catheter 3600. The docking station 10 can be positioned and deployed in a wide variety of different ways. Access can be gained through the femoral vein or access can be percutaneous. In general, any vascular route leading to the pulmonary artery can be used. In one exemplary embodiment, a guidewire followed by a catheter 3600 is advanced into the pulmonary artery PA using the femoral vein, the inferior vena cava, the tricuspid valve, and the right ventricle RV. The docking station 10 can be positioned in the right ventricular outflow tract / pulmonary artery PA to create a landing area for an artificial conduit and valve (e.g., a transcatheter heart valve) 29.

[0101] Referring to FIG. 36B, the docking station shown by FIG. 18 is deployed in the pulmonary artery (PA) of the heart H. FIG. 36C shows the valve 29 deployed in the docking station 10 shown by FIG. 32A. In the example shown by FIG. 36C, FIG. 37A, FIG. 38, FIG. 39A, and FIG. 39B, the valve 29 is depicted as a SAPIEN 3 THV provided by Edwards Lifesciences, although various other valves can be used. In FIG. 36A-FIG. 36C, the heart is in systole. FIG. 37A is an enlarged representation of the docking station 10 and the valve 29 in the pulmonary artery of FIG. 36C. When the heart is in systole, the valve (e.g., a Sapien 3 valve) opens. Blood flows from the right ventricle RV, through the pulmonary artery PA, the docking station 10, and the valve, as indicated by the arrow 3202. FIG. 37B shows a space 3208 representing the valve being open when the heart is in systole. Figure 37B does not show the interface between the docking station 10 and the pulmonary artery for simplicity. The hatched lines in Figure 37B show blood flow through the valve. In an exemplary embodiment, blood is prevented from flowing between the pulmonary artery PA and the docking station 10 by the sealing portion 410, and blood is prevented from flowing between the docking station 10 and the valve by resting the valve in the valve seat 18 of the docking station 10. In this example, blood substantially only flows or can only flow through the valve when the heart is in systole.

[0102] FIG. 38 shows the valve 29 shown by FIG. 36C, the docking station 10, and the heart H when the heart is in diastole. Referring to FIG. 38, when the heart is in diastole, the valve 29 is closed. FIG. 39A is an enlarged representation of the docking station 10 and the valve (e.g., Sapien 3 valve) in the pulmonary artery of FIG. 38. Blood flow in the pulmonary artery PA above the valve 29 (i.e., in the pulmonary artery branch 210) is obstructed by the valve 29 being closed, obstructing blood flow as indicated by the arrows 3400. The solid area 3512 in FIG. 39B represents the valve 29 being closed when the heart is in diastole.

[0103] 39A, the radially outward force 720 of the anchoring / retaining portion 414 against the inner surface 416 is substantially less than the radially outward force 710 exerted by the valve (e.g., a Sapien 3 valve) against the valve seat 18. For example, the radially outward sealing force 720 can be less than ½ the radially outward force 710 exerted by the valve, less than ⅓ the radially outward force 710 exerted by the valve, less than ¼ the radially outward force 710 exerted by the valve, less than ⅛ the radially outward force 710 exerted by the valve, or even less than ⅓ the radially outward force 710 exerted by the valve. A 29 mm size Sapien 3 valve typically exerts a radially outward force 710 of about 42 Newtons. In one embodiment, the radially outward force of a deployed docking station, or one or more portions of a deployed docking station, described herein may be approximately 4 to 16 Newtons, although other forces are possible.

[0104] FIG. 40A shows the docking station shown by FIG. 27 or FIG. 28 being deployed by a catheter 3600. Referring to FIG. 40B, the docking station shown by FIG. 27 or FIG. 28 is deployed in the pulmonary artery PA of the heart H. FIG. 40C shows the valve 29 deployed in the docking station 10 shown by FIG. 40A. In the example shown by FIG. 36C, FIG. 37A, FIG. 38, FIG. 39A, and FIG. 39B, the valve 29 is depicted as a SAPIEN 3 THV provided by Edwards Lifesciences, although various other valves can also be used. In FIG. 40A-FIG. 40C, the heart is in systole. FIG. 41A is an enlarged representation of the docking station 10 and the valve 29 in the pulmonary artery of FIG. 40C. When the heart is in systole, blood flows from the right ventricle RV through the pulmonary artery PA, the docking station 10, and the valve 29, as indicated by the arrow 3202. FIG. 41B shows space 3208, which represents valve 29 being open when the heart is in systole. FIG. 41B does not show the interface between docking station 10 and the pulmonary artery for simplicity. The cross-hatched lines in FIG. 41B show blood flow through valve 29. In an exemplary embodiment, blood is prevented from flowing between pulmonary artery PA and docking station 10 by sealing portion 410, and blood is prevented from flowing between docking station 10 and valve 29 by seating the valve in valve seat 18 of docking station 10. In this example, blood substantially only flows or can only flow through the valve when the heart is in systole.

[0105] FIG 42 shows the valve 29, docking station 10, and heart H as shown by FIG 40C when the heart is in diastole. Referring to FIG 42, when the heart is in diastole, the valve 29 is closed. FIG 43A is an enlarged representation of the docking station 10 and valve 29 in the pulmonary artery PA of FIG 42. Blood flow in the pulmonary artery PA above the valve 29 (i.e., in the pulmonary artery branch 210) is obstructed by the valve 29 being closed, obstructing blood flow as indicated by arrow 3400. The solid area 3512 in FIG 43B represents the valve 29 being closed when the heart is in diastole.

[0106] 43A, the docking station 10 is retained within the pulmonary artery PA by extending one or more of the retention / anchor portions 414 radially outward into the region 210, 212 of the pulmonary artery PA, where the inner surface 416 also extends outward. For example, the retention portions 414 can be configured to extend radially outward into the pulmonary artery bifurcation 210 and / or the pulmonary artery opening 212 to the right ventricle RV. In an exemplary embodiment, the docking station 10 can be an adjustable docking station and / or a multi-component docking station. For example, the docking station 10 can be a nested docking station as shown by FIG. 28, where a first portion 1102 can be deployed such that the retention portions 414 extend radially outward into the pulmonary artery bifurcation 210, and a second portion 1104 can be positioned within the first portion 1102 such that the retention portions 414 are aligned with the pulmonary artery opening 212. The extension of the retention portion 414 into the regions 210, 212 sets the position of the docking station 10 within the pulmonary artery PA and helps prevent pressure P, shown in FIG. 43A, from displacing the docking station.

[0107] The valve 29 used with the docking station 10 can be in a wide variety of different forms. In one exemplary embodiment, the valve 29 can be configured to be implanted within the heart H via a catheter. For example, the valve 29 can be expandable and collapsible to facilitate transcatheter application within the heart. However, in other embodiments, the valve 29 can be configured for surgical application. Similarly, the docking stations described herein can be deployed using transcatheter or surgical application / deployment.

[0108] 44-48 show some examples of many valves or valve configurations that can be used. Any valve type can be used, and some valves that are traditionally surgically applied can be modified for transcatheter implantation. FIG. 44 shows an expandable 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. One example of a trileaflet valve is shown and described in International Publication No. WO 2000 / 42950, ​​which is incorporated herein by reference in its entirety. Another example of a trileaflet 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 trileaflet valve is shown and described in U.S. Pat. No. 6,558,418, which is incorporated herein by reference in its entirety. FIGS. 45-47 show an exemplary embodiment of an expandable trileaflet valve 29, such as Edwards' SAPIEN transcatheter heart valve. Referring to FIG. 45, in one exemplary embodiment, the valve 29 comprises a frame 712 housing a tri-leaflet valve 4500 (see FIG. 46) compressed within the frame 712. FIG. 46 shows the frame 712 in an expanded state and the valve 29 in an open state. FIG. 47 shows the frame 712 in an expanded state and the valve 29 in a closed state. FIG. 48A, FIG. 48B, and FIG. 48C show an example of an expandable valve 29 as shown and described in U.S. Pat. No. 6,540,782, which is incorporated herein by reference in its entirety. An 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 or other valves may be used as valve 29 in the various embodiments disclosed herein.

[0109] 49A, 49B, and 50A-50D show a distal portion of an exemplary embodiment of a catheter 3600 for delivering and deploying the docking station 10. The catheter 3600 can be in a wide variety of different forms. In the illustrated example, the catheter 3600 includes an outer tube / sleeve 4910, an inner tube / sleeve 4912, a docking station connector 4914 connected to the inner tube 4912, and an elongated nosecone 28 connected to the docking station connector 4914 by a connecting tube 4916.

[0110] The docking station 10 can be disposed within an outer tube / sleeve 4910 (see FIG. 49B). The elongated legs 5000 can connect the docking station 10 to the docking station connector 4914 (see FIG. 49B). The elongated legs 5000 can be a retaining portion that is longer than the remainder of the retaining portion 414. A catheter 3600 can be passed over the guidewire 5002 to position the docking station 10 at the delivery site.

[0111] 50A-50D, the outer tube 4910 is gradually retracted relative to the inner tube 4912, the docking station connector 4914, and the elongated nosecone 28 to deploy the docking station 10. In FIG. 50A, the docking station 10 begins to extend from the outer tube 4910. In FIG. 50B, the distal end 14 of the docking station 10 extends from the outer tube 4910. In FIG. 50C, the docking station 10 is extended out of the outer tube while the elongated legs 5000 remain retained by the docking station connector 4914 within the outer tube 4910. In FIG. 50D, the docking station connector 4914 extends from the outer tube 4910 to release the legs 5000, thereby fully deploying the docking station. Similar steps can be used during deployment of the docking station within the circulatory system, and the docking station can be deployed in a similar manner.

[0112] 51 and 54 show an exemplary embodiment of the nosecone 28. In one exemplary embodiment, the nosecone 28 is an elongated flexible tip or distal end 5110 of a catheter that is used to assist in guiding the catheter 3600 into the heart. In the illustrated example, the nosecone 28 is a long, gradually tapered cone, with the narrow distal end of the cone being relatively flexible. In one non-limiting embodiment, the nosecone has a length of 1.5 inches, and the lumen 5200 of the nosecone 28 has an inner diameter of 0.04 inches to accommodate the guidewire 5002. In one embodiment, as the diameter of the nosecone 100 increases from the narrow distal end to the wide proximal end, the cone becomes gradually stiffer. This may be due to an increase in thickness and / or the nosecone can be constructed from different materials having different durometers. Optionally, to prevent an abrupt change in stiffness, the stiffness at the point where the nosecone connects with the outer tube 4910 can be approximately the same as the stiffness of the outer tube 4910. In the example shown by FIG. 51 and FIG. 54, the elongated distal ends 5110 of the nosecone 28 are the same. In one embodiment, the taper of the nosecone 28 extends the entire length or only a portion of the end-to-end length of the nosecone 28. To form the taper, the outer diameter of the nosecone 28 may increase in the distal-to-proximal direction. The taper can be of various shapes and the outer surface of the taper can be at various angles relative to the longitudinal axis of the nosecone 28.

[0113] In one exemplary embodiment, the longer distal end 5110 of the nosecone 28 assists in navigating around bends or curves in the subject's vascular system. As the length of the nosecone 28 increases, more of the tip goes around the bend, creating a "follow-the-leader" effect with the remainder of the nosecone.

[0114] In the example shown by FIG. 51, the base or proximal end 5112 of the nosecone 28 has a proximal angled portion 5308 adjacent to a ledge 5310. The proximal angled portion does not catch on the docking station 10 implanted in the heart when the delivery catheter is withdrawn. Thus, the proximal base portion 5112 allows for easier removal of the delivery system. With reference to FIG. 53, as the angled portion 5308 (or "ramp") of the base portion 5112 is retracted into the outer tube 4910, the ramp 5308 enters the delivery catheter first, then the ledge 5310. When the nosecone 28 engages the outer sleeve / tube 4910, the inner diameter of the outer sleeve rides up on the ramp 5308 and then on the ledge 5310 (which can be flat or substantially flat, e.g., 180° or 180°±5° relative to the longitudinal axis of the nosecone 28). The inner diameter of the outer sleeve / tube 4910 may be slightly smaller than the diameter of the shelf 5310 to ensure a snug fit.

[0115] In one non-limiting example, the shelf 5310 of the nosecone 28 fits snugly within the lumen or outer lumen of the catheter assembly 3600, which can have a diameter of about 0.2 inches or 0.1 inches to 0.4 inches, in one non-limiting example. In one embodiment, the outer diameter of the largest portion of the nosecone 28 can be 0.27 inches or 0.2 inches to 0.4 inches, and the diameter at the distal tip of the nosecone is 0.069 inches or 0.03 inches to 0.1 inches. Again, these dimensions are merely illustrative. For example, the outer diameter or maximum outer diameter of the nosecone 28 can be a diameter larger (e.g., slightly larger as shown) than the outer diameter of the outer tube 4910, the outer diameter of the nosecone 28 can be the same as the outer diameter of the outer tube 4910, or the outer diameter of the nosecone 28 can be a diameter smaller (e.g., slightly smaller) than the outer diameter of the outer tube 4910.

[0116] In the example shown by FIG. 54, the entire base or proximal end / portion 5112 of the nosecone 28 is angled. The continuously angled proximal end 5112 does not get caught on the docking station 10 implanted in the heart when the delivery catheter is withdrawn. Thus, the base portion 5112 allows for easier removal of the delivery system. With reference to FIG. 55, the outer tube 4910 can include a chamfer 5500 that receives and mates with the continuously angled proximal end 5112.

[0117] In one non-limiting example, the continuously angled proximal end 5112 of the nosecone 28 fits snugly into the outer tube / sleeve 4910 (which may optionally be chamfered) of the catheter assembly 3600. The outer diameter or maximum outer diameter of the nosecone 28 can be a larger (e.g., slightly larger) diameter than the outer diameter of the outer tube 4910, the outer diameter of the nosecone 28 can be the same as the outer diameter of the outer tube 4910 as shown, or the outer diameter of the nosecone 28 can be a smaller (e.g., slightly smaller) diameter than the outer diameter of the outer tube 4910.

[0118] The docking station 10 can be coupled to the catheter assembly or to the docking station connector 4914 of the catheter assembly in a wide variety of different ways. For example, the docking station 10 can be coupled to the catheter assembly using a lock, a locking mechanism, a suture (e.g., one or more sutures releasably attached, tied, or braided through one or more portions of the docking station), an interlocking device, a combination thereof, or other attachment mechanism. Some of these coupling or attachment mechanisms can be configured to allow the docking station to be retracted into the catheter assembly without the docking station catching on an edge of the catheter assembly, for example, by constraining the proximal end of the docking station into a smaller cross-section or folded configuration so that the docking station can be adjusted, removed, replaced, etc. FIGS. 56, 57, 57A, and 57B show one non-limiting example of how the docking station 10 can be coupled to the docking station connector 4914. As shown by Figures 50A-50D, in one exemplary embodiment, the docking station 10 self-expands when pushed out of the outer tube. One approach to control the expansion of the docking station 10 is to affix at least one end, such as the proximal end 12, of the stent to the docking station connector 4914. This approach allows the distal end 14 of the stent to expand first without the proximal end expanding (see Figure 50B). The stent is then moved forward relative to the outer tube 4910, disengaging the proximal end 12 from the docking station connector 4914 and allowing the proximal end 12 of the docking station to expand (see Figure 50D).

[0119] One way to accomplish this approach is to include one or more extensions 5000 on at least the proximal end 12 of the stent. In the illustrated example, two extensions are included. However, any number of extensions 5000 can be included, such as two, three, four, etc. The extensions 5000 can be in a wide variety of different forms. The extensions 5000 can engage with a docking station connector 4914 within the outer tube 4910. In one exemplary embodiment, the docking station connector 4914 can engage an inner surface 5600 of the extension 5000. In one exemplary embodiment, other than possible engagement between the inner surface 5600 of the extension 5000 (see FIG. 57A ) and the docking station connector 4914, when the distal portion of the catheter assembly and / or docking station is in a straight or substantially straight configuration, the extension 5000 and the docking station connector 4914 are configured to limit the retaining engagement therebetween to two points, although they may be similarly configured to limit the retaining engagement to another number of points, e.g., 3-6 points. In one exemplary embodiment, when the distal portion of the catheter assembly and / or docking station is in a straight or substantially straight configuration, the inner surface 5600 of the extension 5000 does not contact the docking station connector 4914 due to the radially outward bias of the compressed extension. In this embodiment, the inner surface 5600 of the extension 5000 may contact the docking station connector 4914 due to bending of the catheter assembly 3600 and / or the docking station. The extension 5000 can include a head 5636 having sides 5640 that extend away from a straight portion 5638 at an angle β (see FIG. 57A), such as 30-60 degrees. Such a head 5636 can be approximately triangular as shown, or the angularly extending sides 5640 can be connected together by another shape, such as a rounded shape, a rectangular shape, a pyramidal shape, or another shape. That is, the head 5636 can function in the same manner as the triangular head shown without being triangular.

[0120] The delivery catheter 3600 consistently bends and curves as it moves through the subject's vasculature. A head 5636 that transitions directly from a straight section 5638 of the extension 5000 to a T-shape, curved T-shape, circle, or sphere will generally have more than two points of retaining contact with its holder (excluding possible engagement with the inner surface 5600 (see FIG. 17A) of the extension 5000 and the docking station connector 4914). With reference to FIGS. 57A and 57B, a head 5636 having sides 5640 that extend away from each other at an angle β, such as a triangular head, results in the head 5636 touching the docking station connector 4914 at only two points 5702, 5704. In the example shown by FIG. 57A, the two points are the corners formed by the T-shaped recess 5710. As shown in Fig. 57B, the extension 5000 may tilt as the catheter 3600 and docking station 10 move through the body during delivery. In an exemplary embodiment, this tilting may also result in only two points of contact between the extension 5000 and the docking station connector 4914 (excluding possible engagement between the inner surface 5600 (see Fig. 17A) of the extension 5000 and the docking station connector 4914), as shown in Fig. 57B. Thus, the extension 5000 may tilt during delivery to increase the flexibility of the catheter 3600 in the area of ​​the docking station 10, while the two points of contact prevent binding between the extension 5000 and the connector 4914.

[0121] 56, 57, 57A, and 57B, the head 5636 fits into a T-shaped recess 5710 in the holder to hold the proximal end 12 of the docking station, while the distal end self-expands within the body. The docking station connector 4914 remains within the delivery catheter until it is moved relatively out of the catheter (i.e., by retracting the outer tube / sleeve 4910 or by advancing the connector 4914 (see FIG. 50D)). With reference to FIG. 56, the outer tube / sleeve 4910 of the catheter 3600 can be placed tightly over the connector 4914 such that the head 5636 is captured in the recess 5710 between the outer tube / sleeve 4910 and the body of the connector 4914. This capture within the recess 5710 holds the end of the docking station 10 as it expands. In this manner, the delivery of the docking station 10 is controlled.

[0122] 50D, at the end of expansion of the docking station 10, when the distal end of the stent has finished expanding, the connectors 4914 are moved relatively out of the outer sleeve so that the heads 5636 are free to move radially outward and disengage from their respective recesses 5710 (see FIG. 56).

[0123] In one embodiment, the extensions 5000 are all the same length. As the connector is moved relatively out of the outer tube / sleeve 4910, the recesses 5710 are moved relatively out of the outer sleeve 4910 at the same time. Because the extensions 5000 are all the same length, the recesses 5710 along with the heads 5636 all emerge from the delivery outer sleeve 4910 at the same time. As a result, the heads 5636 of the docking station are all moved radially outward and released at once.

[0124] In an alternative embodiment, the docking station 10 includes extensions 5000 having heads 5636, at least some of the extensions 5000 being longer than the others. As such, as the connector 4914 is gradually moved relatively out of the outer sleeve 4910, the shortest extensions 5000 are released first from their respective recesses 5710. Then, as the connector 4914 is moved relatively further out of the outer sleeve 4910, the longer ones of the extensions 5000 are released from their respective recesses 5710. As described above, in one exemplary embodiment, the docking station 10 can be deployed using a catheter / catheter assembly 3600. The catheter / catheter assembly 3600 is advanced within the circulatory system to a delivery site or treatment area. Once at the delivery site, the docking station 10 is deployed by moving the outer sleeve or tube 4910 towards the inner sleeve or tube 4912 and attached connector 4914 and docking station 10 (see FIGS. 50A-50D). The outer sleeve 4910 can be moved relative to the inner sleeve 4912 in a variety of different ways. FIGS. 58-61 and 62-73 show examples of tools or handles 5800, 6200 that can be used to move the catheter 3600 within the circulatory system and move the outer sleeve 4910 relative to the inner sleeve 4912 of the catheter 3600, for example, to deploy / position the docking station.

[0125] In the example shown by FIGS. 58-61 , the handle 5800 includes a housing 5810, a drive member 5812, and a driven shaft 5814. In the illustrated example, rotation of the drive member 5812 relative to the housing 5810 as indicated by arrow 5816 causes linear movement of the driven shaft 5814 as indicated by arrow 5818. Referring to FIG. 60 , the inner sleeve 4912 is fixedly connected to the housing 5810 as indicated by arrow 6000, and the outer sleeve 4910 is fixedly connected to the driven shaft 5814 as indicated by arrow 6002. Thus, rotating the drive member 5812 in a first direction retracts the outer sleeve 4910 relative to the inner sleeve 4912, and rotating the drive member 5812 in the opposite direction advances the outer sleeve 4910 relative to the inner sleeve 4912.

[0126] 58-61 , the housing 5810 includes an annular recess 5820. The drive member 5812 includes an annular protrusion 5822. The annular protrusion 5822 fits within the annular recess to rotatably couple the drive member 5812 to the housing 5810. The drive member 5812 includes an engagement portion 5830 extending from the housing that allows a user to rotate the drive member 5812 relative to the housing 5810.

[0127] 58-61, the housing 5810 includes a linear recess 5840 or groove (see FIG. 59). The driven shaft 5814 includes a linear protrusion 5842. The linear protrusion 5842 fits within the linear recess 5840 to slidably couple the driven shaft 5814 to the housing 5810.

[0128] In the example shown by FIGS. 58-61 , the drive member 5812 includes an internal thread 5850. The driven shaft 5814 includes an externally threaded portion 5852. The externally threaded portion 5852 meshes with the internal thread 5850 to operably couple the drive member 5812 to the driven shaft 5814. That is, when the drive member 5812 is rotated relative to the housing 5810 as shown by arrow 5816, the rotation of the driven shaft 5814 is prevented by the linear protrusion 5842 that fits into the linear recess 5840. Thus, the rotation of the drive member 5812 within the housing 5810 causes the driven shaft 5814 to slide linearly along the linear recess 5840 as shown by arrow 5818 due to the engagement of the externally threaded portion 5852 meshing with the internal thread 5850. Because the outer shaft / tube 4910 is connected to the driven shaft 5814 and the inner shaft / tube 4912 is connected to the housing 5810 , rotation of the drive member 5812 advances and retracts the outer shaft / tube 4910 relative to the inner shaft / tube 4912 .

[0129] In the example shown by Figures 58-61, the outer shaft / tube 4910 is fixedly connected, such as by threads 5850, within a recess in the driven shaft 5814, and an optional seal 5853 is provided between the outer shaft / tube 4910 and the inner shaft / tube 4912 and / or between the outer shaft / tube 4910 and the driven shaft 5814. A luer port 5862 is fixedly connected to the housing 5810, for example, at a proximal end of the housing 5810 as shown. The inner shaft / tube 4912 is fixedly connected within a recess 5860 of the luer port 5862. The luer port 5862 is configured to receive a guidewire 5002 (see Figure 49) extending through the inner shaft / tube 4912.

[0130] In the example shown by FIGS. 62-67, the handle 6200 includes a housing 6210, a drive wheel 6212, and a driven member 6214. In the illustrated example, rotation of the drive wheel 6212 relative to the housing 6210 as indicated by arrow 6216 causes the driven member 6214 to move linearly as indicated by arrow 6218 (compare the position of the driven member 6214 in FIGS. 64A and 64B). With reference to FIG. 62, the inner sleeve / tube 4912 is fixedly connected to the housing 6210 and the outer sleeve / tube 4910 is fixedly connected to the driven member 6214. Thus, by rotating the drive wheel 6212 in a first direction, the outer sleeve 4910 is retracted relative to the inner sleeve 4912, and by rotating the drive wheel 6212 in the opposite direction, the outer sleeve / tube 4910 is advanced relative to the inner sleeve / tube 4912. While in the various embodiments shown in Figures 58-73 the inner sleeve / tube 4912 is illustrated and described as being connected so as to not move relative to the handle or proximal end of the handle and the outer sleeve / tube 4910 is movable relative to the handle or proximal end of the handle, in an embodiment using a similar concept, the inner sleeve / tube 4912 can be connected so as to be movable relative to the handle or proximal end of the handle and the outer sleeve / tube 4910 can be connected so as to not move relative to the handle or proximal end of the handle, or both the inner sleeve / tube 4912 and the outer sleeve / tube 4910 can be configured to be movable relative to each other and relative to the handle or proximal end of the handle.

[0131] 62-67, the housing rotatably receives the axle 6822 of the drive wheel 6212 to rotatably couple the drive wheel to the housing 6210. The drive wheel 6212 includes an engagement portion 6230 extending from the housing 6210 that enables a user to rotate the drive wheel 6212 relative to the housing 6210.

[0132] 62-67, the housing 6210 includes a linear protrusion 6240 (see FIG. 66). The driven member 6214 includes a linear groove 6242 (see FIGS. 62, 66) into which the protrusion 6240 fits to slidably couple the driven member 6214 to the housing 6210.

[0133] In the example shown by FIGS. 62-67, the driving member 6212 includes a pinion gear 6250. The driven member 6214 includes a rack gear portion 6252. The pinion gear 6250 meshes with the rack gear portion 6252 to operatively couple the driving wheel 6212 to the driven member 6214. That is, when the driving wheel 6212 is rotated relative to the housing 6210 as shown by arrow 6216, the linear protrusion 6240 that fits within the linear groove or recess 6242 causes the driven member 6214 to slide relative to the housing 6210. Thus, the rotation of the driving member 6212 relative to the housing 6210 causes the pinion gear 6250 to drive the rack gear portion 6252 to linearly slide the driven member 6214 relative to the housing 6210 as shown by arrow 6218. The outer shaft / tube 4910 is connected to a driven member 6214 and the inner shaft / tube 4912 is connected to the housing 5810 so that rotation of the drive wheel 6212 advances and retracts the outer shaft / tube 4910 relative to the inner shaft / tube 4912.

[0134] In the example shown by FIGS. 62-67, the outer shaft / tube 4910 is fixedly connected to a support portion extending from the rack gear portion 6252 of the driven member 6214, and optional seals (not shown) are provided between the outer shaft / tube 4910 and the inner shaft / tube 4912 and / or between the outer shaft / tube 4910 and the driven member 6214. A luer port 5862 is fixedly connected to the housing 6210, for example at a proximal end of the housing 6210. The inner shaft / tube 4912 is fixedly connected within a recess 5860 of the luer port 5862. The luer port 5862 is configured to receive a guidewire 5002 (see FIG. 49) extending through the inner shaft / tube 4912.

[0135] 63, in one exemplary embodiment, the catheter 3600 can be flushed by applying fluid to the inner tube 4912, such as through a luer port 5862 to the inner tube. As described above, the delivery catheter 3600 includes an outer lumen formed in the outer tube / sleeve 4910 and an inner lumen formed in the inner tube / sleeve 4912, the inner lumen and inner tube 4912 being longitudinally coaxial with the outer lumen and outer tube 4910. An annular lumen / gap / space 6348 between the inner tube 4912 and the outer tube 4910 may be provided, for example, by the need to provide space for a crimped stent to advance through the catheter 3600. This gap / space 6348 may be initially filled with air, which can later be evacuated and replaced with liquid, for example, saline solution. In this manner, flushing can be performed using the various handle embodiments shown in FIGS. 58-73.

[0136] In one exemplary embodiment, a fluid, such as saline or another suitable fluid, flows from the luer port 5862 through the lumen of the inner tube 4912, as indicated by arrow 6360. In this embodiment, the inner tube 4912 includes one or more irrigation apertures 6354. The fluid flows through the interior of the inner tube 4912 and out the apertures 6354, as indicated by arrow 6370, and into the gap / space 6348.

[0137] As the gap / space 6348 is filled with fluid, air is forced out of the delivery catheter through the distal end of the outer tube 4910. In an exemplary embodiment, the nosecone 28 is disengaged from the distal end of the outer tube 4910 to allow air to flow out of the outer tube and out of the catheter 3600. Fluid also flows through the lumen of the inner tube 4912 to force air out of the lumen. In an exemplary embodiment, air is forced out of the lumen through an opening 6390 at the end of the nosecone 28 (see FIGS. 49A and 49B). This flushing procedure is performed before the delivery catheter 3600 is introduced into the body. This approach of the device and method saves space, for example, compared to providing a side port in the outer tube 4910 to introduce flushing fluid into the delivery catheter assembly or the gap / space 6348.

[0138] 68-73, in one exemplary embodiment, the handle 6200 depicted by FIGS. 62-67 can include a ratchet mechanism 6800. The ratchet mechanism 6800 can be in a wide variety of different forms and can be used with the handle 6200 in a variety of different ways. In one exemplary embodiment, the ratchet mechanism 6800 is used during "recapture" of the docking station 10 and pulling it back into the delivery catheter 3600. The force required to recapture the docking station can be large. Therefore, the ratchet mechanism 6800 can be configured such that when the ratchet mechanism is engaged (FIGS. 68-71), the drive wheel 6212 can only be rotated in a direction that will pull the docking station 10 back into the outer tube / sleeve 4910. That is, the spring force of the docking station 10 is prevented by the ratchet mechanism 6800 from pulling the docking station out of the outer tube again. The operator can continuously reacquire the docking station 10 without causing the docking station to roll back, for example, if the operator releases the drive wheel 6212.

[0139] 68-71, one exemplary ratchet system uses a protrusion 6810 with a stop surface 6812 on one side of the protrusion and a ramp surface 6814 on the other side of the protrusion. FIGS. 68-71 show an engaged state where a ratchet arm 6892 is positioned to engage the protrusion 6810 to allow the drive wheel 6212 to rotate in one direction and prevent the drive wheel from pivoting in the opposite direction. For example, the ratchet arm 6892 can be configured to ride up the ramp surface 6814 to allow the drive wheel 6212 to move in a retract direction 6850. For example, the ratchet arm 6892 can be bent to ride up the tilted ramp surface 6814. The stop surface 6812 is configured to engage the ratchet arm 6892 and prevent the drive wheel from rotating in an advance direction 6852. For example, the stop surface 6812 can be substantially perpendicular to a side surface 6870 of the drive wheel 6212 to prevent the ratchet arm from traveling over the protrusion 6810 .

[0140] 72 and 73 show the ratchet mechanism 6800 with the ratchet arm 6892 disengaged from the protrusion 6810. This allows the drive wheel 6212 to pivot in either direction. For example, the ratchet mechanism 6800 can be placed in a disengaged state when the docking station 10 is deployed to allow the drive wheel 6212 to pivot in either direction.

[0141] In ratchet systems, it is common to have the ratchet teeth on the periphery of the wheel. By having the teeth on the face of the wheel, the diameter of the wheel can be reduced to save space. It also allows, for example, the periphery of the wheel to be used as a thumb grip rather than having a second wheel engaged with the first for gripping. The wheel itself can also be made thinner. The wheel can be made of any suitable material, such as polycarbonate.

[0142] Referring to FIG. 71, in one embodiment, the ratchet arm 6892 can be bent such that a portion of the arm can rest on a stabilizing bar 194 extending from the housing wall or otherwise positioned within the housing to prevent the arm 6892 from twisting when a force from the movement of the wheel is applied to the arm.

[0143] 74-90C show additional embodiments of the docking station 10 and a frame 1500 for a docking station. Any combination or subcombination of the features in the embodiments of Figures 74-90C, or any individual feature, may be used / combined with any combination or subcombination of the features in the embodiments of Figures 4A-73, or any individual feature. Commonly assigned U.S. Patent No. 10,363,130 and International Patent Application No. PCT / US2017 / 016587 are hereby incorporated by reference in their entireties.

[0144] 74-78B, the frame 1500 of the docking station 10 can be sized, shaped, and / or otherwise configured to fit pulmonary arteries of various sizes, shapes, diameters, and geometries. The frame 1500 of the docking station 10 can have any number of compression members 1502, any number of cells 1504, or any number of apexes 1510, or the compression members 1502 or cells 1504 can have any shape that fits pulmonary arteries of various sizes, shapes, and geometries. The compression members 1502 can have any size, shape, thickness, or configuration that retains the valve 29 within the pulmonary artery PA. In addition, the proximal end 12 of the frame 1500 can have a different size, shape, and / or configuration than the distal end 14 of the frame 1500.

[0145] The frame 1500 of the docking station 10 may include a lattice of struts 1502 extending from the proximal end 12 to the distal end 14 and defining the valve seat 18. Each strut 1502 extends from an apex 1510 at the proximal end 12 to a nearest junction 1503, extends between adjacent junctions 1503, and extends from an apex 1510 at the distal end 14 to a nearest junction 1503. As such, each strut 1502 connects with one or more other struts 1502 at the junctions 1503 and / or apexes 1510. The spaces enclosed by the junctions 1503, apexes 1510, and the connected struts 1502 define cells 1504. The struts 1502 may connect at the proximal and distal ends 12, 14 to form a plurality of apexes 1510. The apex 1510 can serve as or be connected to the retention portion 414. The steps 1506 are circumferential rows of struts 1502 extending from the apex 1510 at the proximal end 12 to the nearest joint 1503, circumferential rows of struts 1502 extending between adjacent joints 1503, and / or circumferential rows of struts 1502 extending from the apex 1510 at the distal end 14 to the nearest joint 1503. In the example shown by FIG. 74, the frame 1500 includes four steps. The struts 1502 alternate between converging portions where the joints 1503 point toward the proximal end 12 and converging portions where the joints 1503 point toward the distal end 14, so that the cells 1504 are approximately diamond-shaped. Additionally or alternatively, one or more struts 1502 of one stage 1506 may be continuous with one or more struts 1502 of a succeeding stage 1506. That is, rather than each strut 1502 terminating on one side of a joint 1503 and another beginning on the other side of the joint, one or more of the struts 1502 may be formed from a continuous strip of material that is simply connected to an adjacent strut at a joint 1503.

[0146] 74-75, the frame 1500 can have a height H, which extends from the proximal end 12 to the distal end 14 of the frame, and a seat diameter SD, which is the diameter of the valve seat 18. The frame 1500 can also have a seal width SW, which is the width of the sealing portion 410 at the point between the proximal end 12 and the valve seat 18 where the docking station 10 seals against the pulmonary artery.

[0147] 74 and 75, the frame 1500 of the docking station 10 can have a different number of stages 1506. The number and configuration of the stages 1506 can be determined to provide better fixation, conformance, or apposition of the docking station 10 within the pulmonary artery PA. For example, the docking station 10 can include more stages 1506 for a longer pulmonary artery PA or if more radial force is beneficial.

[0148] As shown in FIG. 74, the frame 1500 of the docking station 10 can be configured for a wide pulmonary artery PA. For example, the frame 1500 of the docking station 10 can be configured for a short and wide pulmonary artery PA. The frame 1500 of the docking station 10 can have four stages 1506 and can have three rows of cells 1504. The frame 1500 can have a height H of 30 mm to 40 mm, such as 32 mm to 38 mm, e.g., 35 mm. The frame 1500 can have a seat diameter SD of 24 mm to 31 mm, such as 26 mm to 29 mm, e.g., 27 mm. The frame 1500 can have a seal width SW of 36 mm to 46 mm, such as 38 mm to 44 mm, e.g., 41 mm.

[0149] The frame 1500 of the docking station 10 can also be configured to accommodate a longer and / or wider pulmonary artery. For example, the frame 1500 of the docking station 10 can be longer and wider. As shown in FIG. 75, the frame 1500 of the docking station 10 can have six columns 1506 and five rows of cells 1504. The frame 1500 of the docking station 10 can have a height H of 45 mm to 51 mm, such as 43 mm to 53 mm, such as 48 mm. The frame 1500 can have a seat diameter SD of 26 mm to 29 mm, such as 24 mm to 31 mm, such as 27 mm. The frame 1500 can have a seal width SW of 46 mm to 52 mm, such as 44 mm to 54 mm, such as 48 mm to 50 mm.

[0150] Although the frame 1500 has been described as having either four or six columns 1506, the frame 1500 can have any suitable number of columns 1506 and any suitable number of rows of cells 1504. For example, the frame 1500 can have three, five, or seven or more columns 1506 and two, four, or six or more rows of cells 1504. The frame 1500 can also have an alternating configuration or geometry, such that the frame 1500 does not have diamond-shaped cells 1504 or that not all of the cells 1504 are diamond-shaped.

[0151] 76A-78B, the docking station 10 can be shaped or otherwise configured to be better stabilized within pulmonary arteries of various sizes, shapes, diameters, and geometries. As shown in FIGS. 76A-77C, the frame 1500 of the docking station 10 can include a different number of apices 1510 at the proximal end 12 and / or distal end 14. The number of apices 1510 can be determined to provide better fixation, conformance, or apposition of the docking station 10 within the pulmonary artery PA. For example, the docking station 10 can include more apices 1510 in pulmonary arteries with larger diameters or varying geometries.

[0152] As shown in Figures 76A-76C, the frame 1500 can be configured to include apexes 1510 at the proximal end 12 and 14 apexes 1510 at the distal end 14 that can provide better apposition within the anatomy of the pulmonary artery PA. As shown in Figures 77A-77C, the frame 1500 can be configured to include apexes 1510 at the proximal end 12 and 12 apexes 1510 at the distal end 14 that can reduce the force required to fold the docking station 10 to conform to a delivery device such as a catheter (e.g., catheter 3600 as shown in Figures 50A-50D) or reduce the outward radial force exerted by the docking station 10 on the pulmonary artery PA. Although the docking station 10 has been described as having either 12 or 14 apexes 1510, the docking station 10 can include any number of apexes 1510. For example, the docking station 10 can have between 8 and 11 apexes 1510, such as 10 apexes 1510, 13 apexes, 15 or more apexes 1510, such as 16 apexes 1510, or any other number of apexes 1510. Additionally, the docking station 10 can be configured with the proximal and distal ends 12, 14 having different numbers of apexes 1510 to accommodate pulmonary arteries PA of various shapes, sizes, and diameters.

[0153] The docking station 10 can also be configured to reduce or prevent further trauma to the pulmonary artery. For example, the apex 1510 of the frame 1500 can include a shallow angle between the sealing portion 410 and the retaining portion 414 to reduce trauma to the tissue of the pulmonary artery while still allowing the docking station 10 to be retained within the pulmonary artery PA. For example, the angle Ω of the transition between the sealing portion 410 and the retaining portion 414 can be 125° to 135°, e.g., 120° to 140°, such as about 130°. The compression members 1502 that define the proximal and distal apexes 1510 can be curved, bent, or otherwise shaped such that the apex 1510 flares radially outward to a position that maintains the docking station 10 within the pulmonary artery when the docking station 10 is deployed and reduces or minimizes trauma caused to the tissue of the pulmonary artery.

[0154] The frame 1500 of the docking station 10 can include one or more eyelets 1507 at the apex 1510. The eyelets 1507 can be circular or round passages or openings that extend through the frame 1500 at the proximal end 12 and / or the distal end 14. As described below, the eyelets 1507 can be used to secure or attach the impermeable material 21 to the frame 1500. In the illustrated embodiment, the frame 1500 includes eyelets 1507 at the proximal and distal ends 12, 14. However, one or more of the apexes 1510 at either the proximal end 12 or the distal end 14 can be free of eyelets 1507, and the apexes 1510 can be substantially solid and rounded. For example, in embodiments in which the impermeable member 21 does not extend to the distal end 14, as described below, the apex 1510 at the distal end 14 can be free of eyelets 1507.

[0155] The frame 1500 may also include one or more elongated legs or extensions 5000 and one or more heads 5636, as described above. The one or more elongated legs or extensions 5000 and the one or more heads 5636 may facilitate the deployment, recapture, and redeployment of the docking station 10. In the illustrated embodiment, each frame 1500 includes two extensions 5000 and two heads 5636 on opposing sides of the proximal end 12. However, the frame 1500 may include extensions 5000 and heads 5636 in any number and in any suitable configuration. For example, the frame 1500 may include an extension 5000 and a head 5636 at the distal end 14, and / or the frame 1500 may have one or more heads 5636 at one or both of the ends 12, 14. The extension 5000 and / or head 5636 can be longer than the apex 1510 while remaining short enough to control the frame 1500 during deployment from a delivery device. For example, the extension 5000 and / or head 5636 can be 0.8 mm to 1.8 mm (or any particular length or subrange between 0.8 mm to 1.8 mm) longer than the apex 1510, 0.5 mm to 3.0 mm (or any particular length or subrange between 0.5 mm to 3.0 mm) longer than the apex 1510, such as 1.3 mm longer than the apex.

[0156] As shown in FIG. 78A and FIG. 78B , the frame 1500 of the docking station 10 can be configured to include a plurality of outflow cells 1508 at the distal end 14 of the frame 1500 that facilitate blood flow through the docking station 10 when the docking station 10 is deployed. The outflow cells 1508 can extend into a bifurcation or branch of the pulmonary artery when the docking station 10 is placed in an elevated position within the pulmonary artery. At least a portion of the outflow cells 1508 can be free from being covered by the impermeable material 21, and the outflow cells 1508 can form at least a portion of the permeable portion 1400. The outflow cells 1508 can be larger than the other cells 1504 of the frame 1500. Each outflow cell 1508 can be defined by one or more outflow compression members 1509. The one or more outflow struts 1509 defining the outflow cells 1508 can be shaped or otherwise configured to define one of the distal ends or apices 1510. The outflow struts 1509 of each outflow cell 1508 can extend distally from two of the distal-most joints 1503 of the cells 1504. The outflow cells 1508, when deployed, can increase the width and stability of the frame 1500 without significantly increasing the height of the frame 1500. For example, the outflow cells can increase the height of the frame by less than 1 / 8 of the remaining height of the frame, increase the height of the frame by less than 1 / 12 of the remaining height of the frame, increase the height of the frame by less than 1 / 16 of the remaining height of the frame, increase the height of the frame by less than 1 / 20 of the remaining height of the frame, or do not increase the height of the frame at all.

[0157] In the illustrated embodiment, each of the outflow cells 1508 is defined in part by one outflow strut 1509 that is bent to define one of the distal ends 1510. Each end of the outflow strut 1509 is attached at a distal-most junction 1503 between two of the distal-most cells 1504, with one cell 1504 between the two cells 1504. In such an embodiment, the frame 1500 may include an eyelet 1507 at the distal-most junction 1503 of the cell 1504 to which the outflow strut 1509 is not attached. In such an embodiment, each outflow cell 1508 is defined by one outflow strut 1509 and four struts 1502.

[0158] 78A and 78B, the outflow compression member 1509 can be bent, constricted, or otherwise shaped such that a distal portion of the outflow cell 1508 defines a narrow end 1513. The narrow end 1513 can help anchor the deployed docking station 10 within the pulmonary artery and can be used to help fold the docking station 10 into a delivery device such as a catheter (e.g., catheter 3600 as shown in FIGS. 50A-50D).

[0159] In the illustrated embodiment, the effluent cells 1508 comprise the distal-most row of cells. However, the frame 1500 may include any suitable configuration of effluent cells 1508. For example, some but not all of the cells in the distal-most row can be effluent cells 1508, or the effluent cells 1508 can comprise two or more rows of cells.

[0160] 79, any of the frames 1500 described herein can be configured to make it easier to deploy, recapture, and / or redeploy the frame 1500. For example, the frame 1500 can be configured to reduce the amount of force required to recapture the frame 1500. As shown in FIG. 79, any of the frames 1500 described herein can have a cross-section with a maximum transition angle Θ at any location along the frame 1500. The maximum transition angle Θ defines the maximum angle between tangents at the closure points along the frame 1500. For example, the maximum transition angle can be measured as the angle between tangents at any two points 0.1 mm apart along the frame contour. The frame 1500 can be shaped and configured to set the maximum transition angle Θ so that the docking station 10 can be easily deployed, recaptured, and redeployed. Frame 1500 can be configured such that the maximum transition angle Θ is minimized so that large internal forces within frame 1500 required to compress the frame back into the catheter do not prevent frame 1500 from being recaptured or redeployed. For example, cross section 1501 is shaped and configured such that the maximum transition angle Θ is less than 55°, less than 50°, or less than 60°, such as 45°.

[0161] 80A, 80B, and 80C, the struts 1502 of the docking station 10 can be configured to provide a more resilient valve seat 18 or to provide a greater radial force against the valve 29 when the valve 29 is deployed in the valve seat 18. In some exemplary embodiments, the frame 1500 can be configured such that the band 20 (see FIG. 18) can be omitted. Additionally or alternatively, the frame can be configured such that the impermeable member 21 does not include additional stitching, which may increase radial resistance as described below. As shown in FIGS. 80A-80C, the struts 1502 of the step 1506 proximate the valve seat 18 can be thicker or have an increased cross-sectional width or diameter relative to the struts 1502 of other portions of the frame 1500. In the illustrated embodiment, the compression members 1502 of the two stages 1506 in the center of the frame 1500 (i.e., in the region of the valve seat 18) are thicker than the compression members 1502 of the other stages 1506. However, the frame 1500 of the docking station 10 can have a variety of other configurations that provide a more resilient valve seat 18 or provide a greater radial force against the valve 29 when the valve 29 is deployed in the valve seat 18. For example, the compression members 1502 of any of the other stages 1506 can also have an increased cross-sectional width or diameter, and none of the compression members 1502 of the central two stages 1506 can have an increased cross-sectional width or diameter.

[0162] Although the docking station 10 has been described as having thicker struts 1502 or struts 1502 with increased cross-sectional width or diameter that provide a more resilient valve seat 18 and / or exert a greater radial force against the deployed valve 29, the docking station 10 can be configured in other manners to provide the same effect. For example, the struts 1502 and / or portions of the frame 1500 proximate the valve seat 18 can include a stronger, less elastic, and / or more resilient metal or material, the joints 1503 proximate the valve seat 18 can be stronger and / or thicker, or the lattice structure of the frame 1500 can be stronger near the valve seat 18, such as by increasing the number and decreasing the length of the struts 1502 in the step 1506 proximate the valve seat 18.

[0163] 81A-81D, the fabric or impermeable material 21 can be cut, configured, or otherwise shaped such that the impermeable material 21 does not protrude and / or tear when the docking station 10 is compressed or deployed. The impermeable material 21 can be cut, configured, or otherwise shaped such that the impermeable material 21 does not cover at least a portion of the frame 1500 near the proximal end 12 and / or the distal end 14. The impermeable material 21 can be cut or shaped such that the impermeable material 21 does not cover at least a portion of the space not defined by one of the cells 1504 near the proximal end 12 and / or the distal end 14. The impermeable material 21 can be configured or cut to the desired shape before the impermeable material 21 is attached to the frame 1500, or the impermeable material 21 can be attached to the frame 1500 and then cut to the desired shape.

[0164] At the proximal end 12 and distal end 14, the frame 1500 can include a number of openings 1511 between the struts 1502 and the apexes 1510 in the portions of the frame 1500 not defined by the cells 1504. The openings 1511 are generally triangular in shape and are defined in part by the two struts 1502, the two apexes 1510, and the joints 1503. The impermeable material 21 can be cut or shaped such that the impermeable material 21 does not cover at least a portion of the openings 1511 at the proximal end 12 and / or distal end 14.

[0165] The impermeable material 21 can be cut, configured, or otherwise shaped in a variety of ways such that the impermeable material 21 does not protrude or tear when the docking station 10 is compressed or deployed. The impermeable material 21 can be cut or shaped such that the impermeable material 21 can be attached or disposed on the frame 1500 such that the impermeable material 21 can cover at least a portion of the cells 1504 but not at least a portion of the openings 1511 at the proximal end 12 and / or distal end 14.

[0166] As shown in FIG. 81A, the impermeable material 21 can be shaped or cut such that the impermeable material 21 substantially covers each cell 1504, substantially covers half of each opening 1511 at the proximal end 12, and substantially covers half of each opening 1511 at the distal end 14. However, the impermeable material 21 can be shaped or cut such that the impermeable material 21 substantially covers each cell 1504, substantially covers one-quarter, one-third, two-thirds, three-quarters, or any other suitable amount of each opening 1511 at the proximal end 12, and substantially covers one-quarter, one-third, two-thirds, three-quarters, or any other suitable amount of each opening 1511 at the distal end 14. Referring again to FIGS. 23A and 23B, the docking station 10 can be used with circulatory system anatomies of different sizes. By removing a portion of the material 21 within the opening 1511 at the proximal and / or distal ends, when the docking station is used in smaller circulatory system anatomical structures (e.g., FIG. 23B), the material 21 within the opening does not protrude or protrusion is reduced.

[0167] As shown in FIG. 81B, the impermeable material 21 substantially covers each cell 1504, substantially covers three-quarters of each opening 1511 at the proximal end 12, and substantially does not cover the openings 1511 at the distal end 14.

[0168] As shown in FIG. 81C, the impermeable material 21 substantially covers each cell 1504, substantially covers the openings 1511 at the proximal end 12, and substantially does not cover the openings 1511 at the distal end 14.

[0169] In each of the illustrated embodiments, the impermeable material 21 is cut horizontally or straight. However, the impermeable material 21 can be cut or shaped in any suitable direction or pattern. For example, the impermeable material 21 can be cut or shaped in a rounded or sinusoidal pattern. In addition, the impermeable material 21 has been described as covering each of the openings 1511 at the proximal end 12 in a uniform manner and covering each of the openings 1511 at the distal end 14 in a uniform manner. However, the impermeable material 21 can be cut or shaped such that the openings 1511 at each end 12, 14 are not covered in a uniform manner. For example, each of the openings 1511 at either end 12, 14 can be covered in a different manner or amount than the other openings 1511. Additionally, the impermeable material 21 can be cut or shaped larger than desired so that the impermeable material 21 can be disposed or attached to the compression member 1502, as described in more detail below.

[0170] The impermeable material 21 may also be cut or otherwise shaped such that it does not cover at least a portion of the most distal cell 1504 or the outflow cell 1508. In such an embodiment, the most distal cell 1504 or the outflow cell 1508 and a portion of the opening 1511 may form the permeable portion 1400. As shown in FIG. 81D, the impermeable material 21 may be cut or otherwise shaped such that it substantially covers the most proximal cell 1504, substantially does not cover the opening 1511 at the proximal end 12, substantially covers one-half of each of the most distal cells 1502, and substantially does not cover the opening 1511 at the distal end 14. The impermeable material 21 may be cut or otherwise shaped such that it extends horizontally at a point substantially equivalent to the location of the most distal junction 1503.

[0171] In the embodiment shown in FIG. 81D, the impermeable covering 21 substantially covers one-half of the distal-most cells 1504. However, the impermeable covering 21 can cover any amount of the distal-most cells 1504. For example, the impermeable covering 21 can be cut or shaped to cover one-quarter, one-third, two-thirds, three-quarters, or any other suitable amount of the distal-most cells 1504. In the illustrated embodiment, the impermeable material 21 does not substantially cover the openings 1511 at the proximal end 12. However, the impermeable material 21 can cover the openings 1511 at the proximal end 12 in any amount or manner, such as in the manners shown and described in FIG. 81A, FIG. 81B, and FIG. 81C. Additionally, although impermeable material 21 is illustrated as extending horizontally across the distal-most junction, impermeable material 21 can have any other suitable shape that extends across the distal-most cell 1504 and junction 1503. For example, impermeable material 21 can have a rounded, curved, sinusoidal, or any other cut or shape that extends across the distal-most cell 1504 and junction 1503.

[0172] Although the various configurations of impermeable material 21 have been described and illustrated as being used with the four section 1506 frame 1500 of Figure 74, the various configurations of impermeable material 21 may be applied to any other docking station 10 described herein. For example, the various configurations of impermeable material 21 may be used with the six section 1506 frame 1500 of Figures 75-77C, with the frame 1500 having outflow cells 1508 of Figures 78A and 78B, with the frame 1500 having thicker struts 1502 of Figures 80A-80C, or with any other frame 1500 described herein.

[0173] 82A-85E, the impermeable material 21 can be attached to, secured around, or otherwise affixed to the frame 1500 of the docking station 10 in a variety of ways. For example, the impermeable material can be attached to the frame 1500 using sewing or electrospinning, or the impermeable material 21 can be made from a sutureless material.

[0174] As shown in FIGS. 82A-84I, the impermeable material 21 can be attached to the frame 1500 by sewing one or more pieces of the impermeable material 21 together and then onto the frame 1500. As shown in FIGS. 83-84I, the frame 1500 can include one or more eyelets 1507 at the apexes 1510, which can facilitate attachment of the impermeable material 21 to the frame 1500. In the illustrated embodiment, each apex 1510 that does not include an elongated leg 5000 includes an eyelet 1507. However, the number of eyelets 1507 can vary and each apex 1510 can include neither an elongated leg 5000 nor an eyelet 1507. For example, the apex 1510 at the distal end 14 can have neither an eyelet 1507 nor an elongated leg 5000.

[0175] As shown in Figures 82A-82I, the impermeable cover 21 can have a proximal portion 1520 and a distal portion 1530. The proximal portion 1520 can be sized and shaped to cover a desired portion of the frame 1500 between the valve seat 18 and the proximal end 12. The distal portion 1530 can be sized and shaped to cover a desired portion of the frame 1500 between the valve seat 18 and the distal end 14. In the illustrated embodiment, the impermeable member 21 has two portions 1520, 1530. However, the impermeable member 21 can have any number of portions secured together to form the impermeable member 21. For example, the impermeable member can be made from a single piece or can have three, four, five, or more portions.

[0176] The proximal portion 1520 has a first edge 1522, a second edge 1524, a first end 1526, and a second end 1528, and the distal portion 1530 has a first edge 1532, a second edge 1534, a first end 1536, and a second end 1538. As described in more detail below, the first edges 1522, 1532 can be sized and shaped to fit the valve seat 18 of the frame 1500, the second edge 1524 of the proximal portion 1520 can be sized and shaped to fit the frame 1500 at a desired location between the valve seat 18 and the proximal end 12, and the second edge 1534 of the distal portion 1530 can be sized and shaped to fit the frame 1500 at a desired location between the valve seat 18 and the distal end 14. In the illustrated embodiment, the proximal portion 1520 and the distal portion 1530 are shaped such that the first ends 1526, 1536 are approximately in the shape of the apex 1510. However, the proximal portion 1520 and the distal portion 1530 can be shaped in a wide variety of ways. For example, the proximal portion 1520 and the distal portion 1530 can be shaped or otherwise configured such that the impermeable material 21 has any of the shapes or configurations shown and described in Figures 81A-81D.

[0177] As shown in FIGS. 82B and 82C, a first end 1526 of the proximal portion 1520 can be folded or looped and secured to a second end 1528 of the proximal portion 1520 to form a proximal portion joint 1525.

[0178] 82D, a first end 1536 of the distal portion 1530 can be folded or looped and secured to a second end 1538 of the distal portion 1530 to form a distal portion joint 1535. The first ends 1526, 1536 can be secured to the second ends 1528, 1538 in any suitable manner. For example, the first ends 1526, 1536 can be secured to the second ends 1528, 1538 by sewing with thread or sutures, by adhesive, by fasteners, or by any other suitable means.

[0179] As shown in FIGS. 82E-82I , the proximal portion 1520 can be secured to the distal portion 1530 such that a second edge 1524 of the proximal portion 1520 is opposite a second edge 1534 of the distal portion 1530. A first edge 1522 of the proximal portion 1520 can overlap a first edge 1532 of the distal portion 1530 to create an inner joint 1542. In one embodiment, the proximal portion joint 1525 is not aligned with the distal portion joint 1535 when the proximal portion 1520 and the distal portion 1530 are secured together. Offsetting the proximal portion joint 1525 and the distal portion joint 1535 can increase the ease of manufacture of the impermeable member 21 and / or increase the strength and resilience of the impermeable member 21. The proximal portion joint 1525 can be offset from the distal portion joint 1535 such that the proximal portion joint 1525 aligns with one of the apexes 1510 and / or joints 1503 and the distal portion joint 1535 aligns with another one of the apexes 1510 and / or joints 1503. For example, the proximal portion joint 1525 and the distal portion joint 1535 can be offset such that when the impermeable member 21 is attached to the frame 1500, the proximal portion joint 1525 and the distal portion joint 1535 can each extend along one of the joints 1503.

[0180] The proximal portion 1520 can be secured to the distal portion 1530 in any suitable manner. For example, a first edge 1522 of the proximal portion 1520 can be secured to a first edge 1532 of the distal portion 1530 by sewing with thread or sutures, by adhesive, by fasteners, or by any other suitable means.

[0181] In one embodiment, the proximal and distal portions 1520, 1530 each include a plurality of apertures 1540 along the first edges 1522, 1532, the first ends 1526, 1536, and the second ends 1528, 1538. The apertures 1540 may facilitate assembly of the impermeable material 21, such as by serving as guides for sutures or threads to be sutured therethrough. The apertures 1540 may be formed by any suitable process, such as cutting or laser drilling.

[0182] As shown in FIGS. 82E-I, the proximal portion 1520 can be attached to the distal portion 1530 near the inner joint 1542 by an interlocking stitch that provides a radial force against the valve 29 when the valve 29 is deployed in the valve seat 18. The proximal portion 1520 can be positioned along or on the distal portion 1530 such that the first edges 1522, 1532 overlap. The suture 1560 can be threaded (radially inward) through the proximal portion 1520 and the distal portion 1530 between the first edges 1522, 1532 at a first point 1543a. The suture 1560 can then be threaded back (radially outward) through the proximal portion 1520 and the distal portion 1530 in the opposite direction at a second point 1543b that is circumferentially spaced from the first point 1543a. The suture 1560 can then be repeatedly threaded in and out of the proximal portion 1520 and the distal portion 1530 at other points 1543 until the suture 1560 is substantially around the circumference of the proximal portion 1520 and the distal portion 1530 .

[0183] Once the suture 1560 has been passed substantially around the circumference of the proximal portion 1520 and the distal portion 1530, the suture 1560 can be returned in the opposite direction through the proximal portion 1520 and the distal portion 1530. Once the suture 1560 has been returned in the opposite direction through the proximal portion 1520 and the distal portion 1530, the suture 1560 can be passed through the proximal portion 1520 and the distal portion 1530 at the same point 1543 such that the suture 1560 fills the space between the previous stitches of the suture 1560 along or near the inner joint 1542. Thus, the circumference of the impermeable material 21 at or near the inner joint 1542 can be substantially covered by the suture 1560 on both sides of the impermeable material 21.

[0184] 82J and 82K, the proximal portion 1520 and the distal portion 1530 can be cut, shaped, or otherwise formed from one or more pieces of fabric 23. The fabric 23 can include fibers 24 that are approximately vertically and horizontally disposed when the fabric 23 is oriented vertically. In the illustrated embodiment, the proximal portion 1520 and the distal portion 1530 are cut from the same fabric 23. However, the proximal portion 1520 can be cut from a first fabric 23 and the distal portion 1530 can be cut from a second fabric 23.

[0185] The proximal portion 1520 can be cut from the fabric 23 such that an angle β is formed between the horizontally oriented fibers 24 and a line perpendicular to the center of the first edge 1522 of the proximal portion 1520. Alternatively, a fabric can be selected having fibers oriented at the angle β. The proximal portion 1520 can be cut (or the fiber orientation can be selected) in a manner that increases the strength and elasticity of the proximal portion 1520 and / or facilitates assembly of the impermeable member 21 and attachment of the impermeable member 21 to the frame 1500. In one embodiment, the proximal portion 1520 can be cut such that the angle β is about 90°, as shown in FIG. 82J. In another embodiment, the proximal portion 1520 can be cut such that the angle β is between 20° and 70°, such as between 30° and 50°, e.g., 45°, as shown in FIG. 82K.

[0186] The distal portion 1530 can be cut from the fabric 23 such that an angle Δ is formed between the horizontally oriented fibers 24 and a line perpendicular to the center of the first edge 1532 of the distal portion 1530. Alternatively, a fabric can be selected having fibers oriented at the angle Δ. The distal portion 1530 can be cut (or the fiber orientation can be selected) in a manner that increases the strength and elasticity of the distal portion 1530 and / or facilitates assembly of the impermeable member 21 and attachment of the impermeable member 21 to the frame 1500. In one embodiment, the distal portion 1530 can be cut such that the angle Δ is about 90°, as shown in FIG. 82J. In another embodiment, the distal portion 1530 can be cut such that the angle Δ is between 20° and 70°, such as between 30° and 50°, e.g., 45°, as shown in FIG. 82K.

[0187] Forming the proximal portion 1520 and the distal portion 1530 with the fibers 24 of the fabric 23 at an angle can improve the strength or elasticity of the impermeable member 21 and / or facilitate assembly of the impermeable member 21. In the illustrated embodiment, the angles β and Δ are substantially the same. However, the angles β and Δ can be substantially different.

[0188] As shown in FIG. 83, the impermeable material 21 can be appropriately positioned or disposed within the frame 1500. The impermeable material 21 can be positioned such that the inner joint 1542 is substantially aligned with the center of the valve seat 18 of the frame 1500. The impermeable material 21 can also be positioned such that the second edge 1524 of the proximal portion 1520 is substantially aligned with the desired compression members 1502, joints 1503, and / or apexes 1510 near the proximal end 12 and the second edge 1534 of the distal portion 1530 is substantially aligned with the desired compression members 1502, joints 1503, and / or apexes 1510 near the distal end 14. In the illustrated embodiment, the impermeable material 21 extends from the proximal end 12 toward the distal end 14 of the frame 1500 and does not extend to the distal-most row of cells 1504. The impermeable material 21 can also be configured such that the impermeable material 21 does not cover the openings 1511 at the proximal end 12. However, the impermeable material 21 can be sized and shaped in any suitable configuration. For example, the impermeable material 21 can extend to the distal end 14 of the frame 1500, and the impermeable material 21 can cover the cells 1504 and the openings 1511 near the ends 12, 14 in any amount or configuration, such as the configurations shown and described in FIGS.

[0189] Optionally, the impermeable member 21 can be configured and / or positioned such that the proximal portion joint 1525 and the distal portion joint 1535 increase the strength or resilience of the docking station 10 or facilitate attachment of the impermeable member 21 to the frame 1500. As shown in dotted lines in FIG. 83, the impermeable member 21 can be configured and / or positioned such that the proximal portion joint 1525 is aligned with the apex 1510 and / or one of the one or more joints 1503. The impermeable member 21 can also be configured and / or positioned such that the distal portion joint 1535 is aligned with the apex 1510 and / or one of the one or more joints 1503. The proximal portion joint 1525 can be aligned with a different apex 1510 and / or joint 1503 than the distal portion joint 1535. For example, the proximal portion joint 1525 can be offset from the distal portion joint 1535 by one junction 1503. In the illustrated embodiment, the proximal portion joint 1525 and the distal portion joint 1535 are aligned with the junction 1503 but are not aligned with any of the apexes 1510. However, the proximal portion joint 1525 and the distal portion joint 1535 can be positioned and / or configured in a variety of manners. For example, one or both of the proximal portion joint 1525 and the distal portion joint 1535 can each be aligned with one of the apexes 1510.

[0190] 84A-84I, the impermeable material 21 can be attached to the frame 1500 by one or more threads or sutures 1560. As shown in FIGS. 84A-84D, the impermeable material 21 can be attached to the proximal end 12 of the frame 1500. The impermeable material 21 can be positioned such that the proximal portion of the impermeable material 21 is aligned with the desired proximal step 1506, apex 1510, or junction 1503. The one or more threads or sutures 1560 can be sutured to or looped around the compression member 1502 of the proximal-most step 1506. At a point near the proximal-most junction 1503 to which the impermeable material 21 extends, the suture 1560 can be threaded through the impermeable material 21, looped around the strut 1502, and returned through the impermeable material 21 on the other side of the strut 1502. This stitch can be repeated until the suture 1560 extends substantially the length of the strut 1502. Near the apex 1510, the stitch can be repeated such that the suture 1560 descends the successive struts 1502 of the stage until the suture 1560 extends substantially to the junction 1503. This stitch can be repeated until the suture 1560 extends substantially along each strut 1502 of the proximal-most stage 1506 and the suture 1560 extends substantially circumferentially around the frame 1500.

[0191] As shown in Figures 84E and 84F, the impermeable material 21 can be attached near the distal end 14 of the frame 1500. The impermeable material 21 can be positioned such that a distal portion of the impermeable material 21 is aligned with a desired distal step 1506, apex 1510, or junction 1503. In the illustrated embodiment, a suture 1560 can be threaded through the impermeable material 21 at a point near the junction 1503 that defines the proximal end of the distal-most cell 1504, looped around the strut 1502, and returned through the impermeable material 21 on the other side of the strut 1502. This stitch can be repeated until the suture 1560 extends substantially the length of the strut 1502. Near the distal-most junction 1503 to which the impermeable material 21 extends, the stitching can be repeated such that the suture 1560 descends the struts 1502 following the step 1506 until the suture 1560 extends substantially to the junction 1503. The stitching can be repeated until the suture 1560 extends substantially along each strut 1502 of the distal-most step 1506 to which the impermeable material 21 extends, and the suture 1560 extends substantially circumferentially around the frame 1500.

[0192] As shown in Figures 84G-84I, the impermeable material 21 can be secured to the remaining stages 1506 by one or more sutures 1560 using stitches similar to those described in Figures 84A-84F. The stitches can be at any angle relative to the struts 1502 of the frame. For example, the stitches can form an angle of 45° to 90° with the struts 1502. In the illustrated embodiment, one or more sutures 1560 secure the impermeable material 21 to each strut 1502 of each stage 1506 that the impermeable material 21 covers. However, the impermeable material 21 does not have to be secured to each strut 1502 of each stage 1506 that the impermeable material 21 covers. For example, the impermeable material 21 may or may not be attached to each compression member 1502 of each covered stage 1506, and / or the impermeable material 21 may or may not be attached to some of the stages 1506.

[0193] As shown in FIG. 84C, the impermeable material 21 may be further secured to the frame 1500 with one or more vertical stitches 1544. After a suture 1560 is sewn around one of the compression members 1502 at the most proximal step 1506 and the suture 1560 extends substantially from the junction 1503 to the apex 1510, the suture 1560 may be threaded through the impermeable material 21, through the eyelet 1507, and back through the impermeable material 21 to form the vertical stitch 1544. The suture 1560 may then be sewn around the compression members 1502 descending toward the junction 1503. Although the vertical stitch 1544 has only been illustrated as securing the impermeable material 21 to the eyelet 1507 at the apex 1510 of the proximal end 12, the vertical stitch 1544 may be used at other locations on the frame 1500. For example, vertical stitches 1544 may be used in embodiments where the impermeable material 21 extends to the apex 1510 at the distal end 14, or in embodiments where the frame 1500 includes outflow cells 1508 and the impermeable material 21 extends to the apex 1510 near the distal end 14. However, the impermeable material 21 may not be secured to the frame 1500 with one or more vertical stitches (e.g., FIG. 84I).

[0194] 85A-85E, in another exemplary embodiment, the impermeable material 21 may be attached to the frame 1500 by a coating and / or adhesive material 1570. The coating and / or adhesive material may take a wide variety of different forms. For example, the coating and / or adhesive material may be a liquid, solid, hot melt, etc. material. The coating and / or adhesive material may be adhered to the impermeable material 21 and / or the frame 1500. In one exemplary embodiment, the adhesive material 1570 surrounds or coats the frame 1500 but does not adhere to the frame 1500, but adheres to and coats the frame 1500.

[0195] In one exemplary embodiment, the coating and / or adhesive material is a fiber material. In one exemplary embodiment, the coating and / or adhesive material 1570 can be applied by electrospinning or otherwise depositing the adhesive fiber material 1570 to adhere the impermeable material 21 to the frame 1500. This can be done in place of some or all of the sutures described above. In one exemplary embodiment, the electrospinning or other deposition of the adhesive fiber material 1570 replaces all of the stitching of the docking station. The coating and / or adhesive 1570 can be a polymer fiber, nanofiber, or thread, such as polytetrafluoroethylene (PTFE), or expanded PTFE (ePTFE), polyetherketone (PEEK), polysulfone (PSU, PPSU), and polyethylene (HDPE, UHMWPE).

[0196] 85A, the impermeable material 21 can be disposed around or within the frame 1500 and positioned such that the impermeable material 21 is in a desired location and substantially in contact with one or more struts 1502 of the frame 1500. For example, the impermeable material 21 can be positioned such that the inner joint 1542 is substantially aligned with the center of the valve seat 18 of the frame 1500. The impermeable material 21 can also be positioned such that the second edge 1524 of the proximal portion 1520 is aligned with the desired struts 1502, joints 1503, and / or apex 1510 near the proximal end 12 and the second edge 1534 of the distal portion 1530 is aligned with the desired struts 1502, joints 1503, and / or apex 1510 near the distal end 14. The nozzle 1569 can be positioned above and facing the impermeable material 21 and the one or more compression members 1502. The nozzle 1569 can be positioned on the outside or inside of the frame 1500, facing the impermeable material 21 and the one or more compression members 1502. In embodiments where the impermeable material 21 is attached to the inside of the frame 1500, the nozzle 1569 can be positioned on the outside of the frame 1500, and in embodiments where the impermeable material 21 is attached to the outside of the frame 1500, the nozzle 1569 can be positioned on the inside of the frame 1500.

[0197] As shown in FIG. 85B, the nozzle 1569 can be positioned above the compression member 1502 and the impermeable material 21 such that an opening of the nozzle 1569 is directed toward the compression member 1502 and the impermeable material 21. As shown in FIG. 85C, a coating and / or adhesive 1570 can be sprayed or otherwise deposited from the nozzle 1569 onto the impermeable material 21 and the compression member 1502. The nozzle 1569 can coat both the impermeable material 21 and the compression member 1502 with the coating and / or adhesive 1570. As shown in FIG. 85D, additional coating and / or adhesive 1570 can be deposited onto the impermeable material 21 and the compression member 1502 such that the coating and / or adhesive 1570 accumulates along the sides of the compression member 1502. 85E, more coating and / or adhesive 1570 is deposited on the impermeable material 21 and the compression member 1502 such that the coating and / or adhesive 1570 extends from the impermeable material 21 on one side of the compression member 1502, over the compression member 1502, to the impermeable material 21 on the other side of the compression member 1502, substantially encapsulating the compression member 1502 in the fibrous material. The coating and / or adhesive 1570 is then allowed to dry, cure, or otherwise solidify, thereby substantially securing the impermeable material 21 to the frame 1500.

[0198] The coating and / or adhesive 1570 may be sprayed or otherwise deposited on one or more of the compression members 1502 until the impermeable material 21 is sufficiently attached to the frame 1500. In the illustrated embodiment, the coating and / or adhesive 1570 is deposited along the steps 1506 that align with the second edges 1524, 1534 of the impermeable material 21. However, the coating and / or adhesive 1570 may be deposited in any suitable manner to secure the impermeable material 21 to the frame 1500. For example, the coating and / or adhesive 1570 may be deposited only at certain locations along the steps 1506, such as only at the joints 1503 and apexes 1510.

[0199] 86A-89D, the docking station 10 can include one or more radiopaque markers 1580 that can aid in the deployment of the docking station 10 as well as the placement of the valve 29 within the valve seat 18. The one or more radiopaque markers 1580 can be radiopaque or highly radiopaque such that the one or more radiopaque markers 1580 can be identified under fluoroscopy or a similar imaging process. The one or more radiopaque markers 1580 can be disposed on, attached to, or otherwise affixed to the docking station 10 in a variety of ways, such as those described in more detail below. The one or more radiopaque markers 1580 can include any material or combination of materials that are radiopaque or that increase the radiopacity of at least a portion of the valve seat 18. For example, the one or more radiopaque markers 1580 can include barium sulfate, bismuth, tungsten, tantalum, platinum iridium, gold, or any other material that is opaque to fluoroscopy, x-rays, or similar radiation, or any combination thereof. As shown in Figs. 86A-D, the radiopaque markers 1580 are disc-shaped, circular, or octagonal. However, the one or more radiopaque markers 1580 can be configured to reduce axial movement and can be any suitable shape. For example, the one or more radiopaque markers 1580 can be hexagonal, triangular, rectangular, oval, 3D, or any other shape or configuration. The radiopaque marker 1580 can also include an aperture 1582 extending through a central portion of the marker 1580. The aperture 1582 can be sized to allow a suture to pass through.

[0200] As shown in FIGS. 87A-90C, one or more radiopaque markers 1580 can be attached to the frame 1500 of the docking station 10. In certain implementations, the radiopaque markers 1580 can be attached or attached to the compression members 1502 or joints 1503 in the valve seat 18 of the frame 1500, with the radiopaque markers 1580 attached to the frame 1500 in any suitable manner. For example, the radiopaque markers 1580 can be attached to the frame 1500 by adhesive, sutures, a press fit, a snap fit, or any other suitable means. The frame 1500 can include three or more radiopaque markers 1580 spaced circumferentially around the valve seat 18 to establish an annular plane through the valve seat 18 of the docking station 10. However, the frame 1500 can include fewer than three radiopaque markers 1580. In other implementations, the radiopaque marker 1580 can be attached or adhered to the opaque material 21, as further described anywhere in this disclosure, with the radiopaque marker 1580 being attached or adhered at or near the compression members 1502 or joints 1503 of the frame 1500, or being attached or adhered away from the compression members 1502 and joints 1503 of the frame 1500.

[0201] 87A, 87B, and 87C, the frame 1500 can include one or more marker settings 1584 at one or more joints 1503 of the valve seat 18. The one or more marker settings 1584 can be sized and shaped to receive one of the radiopaque markers 1580. The one or more marker settings 1584 can be an opening defined by the one or more compression members 1502 or can be a recess in the frame 1500 that can receive one of the radiopaque markers 1580.

[0202] 88, one or more radiopaque markers 1580 may be disposed on one or more marker settings 1584 and secured by any suitable means. For example, one or more radiopaque markers 1580 may be secured to one or more marker settings 1584 by a press fit, a snap fit, adhesive, fasteners, or any other suitable manner.

[0203] Additionally or alternatively, as shown in Figures 89A-89D, one or more radiopaque markers 1580 can be included in the impermeable material 21 such that when the impermeable material 21 is attached to the frame 1500, the one or more radiopaque markers 1580 are disposed within the valve seat 18. The one or more radiopaque markers 1580 can be sewn onto, sewn into, enclosed in a pocket, or otherwise attached to the impermeable material 21 such that when the impermeable material 21 is disposed on the frame 1500, the one or more radiopaque markers 1580 are disposed about the valve seat 18.

[0204] The radiopaque markers 1580 can be attached or affixed to the opaque material 21 at various locations relative to the struts 1502 and joints 1503 of the frame. In some implementations, the radiopaque markers 1580 can be attached or affixed to or near the struts 1502 or joints 1503 of the frame 1500. In certain implementations, the radiopaque markers 1580 can be attached or affixed away from the struts 1502 and joints 1503 of the frame 1500, such as at a location within a central portion of the cells 1504 of the frame. Positioning the radiopaque markers 1580 within a central portion of the cells 1504 can provide certain technical advantages. One technical advantage is that overlap between the radiopaque marker 1580 and associated attachment material and the compression members 1502 and joints 1503 of the frame 1500 can be minimized, thereby reducing the folded profile of the frame 1500. Another technical advantage is that physical contact between the radiopaque marker 1580 and the frame 1500 can be minimized, thereby avoiding material fatigue, degradation, and / or corrosion. A further technical advantage is that placement within the central portion of the cell 1504 allows the radiopaque marker 1580 to move radially outward to accommodate expansion of the valve 29 within the frame 1500, thereby minimizing physical contact between the frame 712 of the valve 29 and the frame 1500 and avoiding interference with the proper functioning of the valve 29.

[0205] As shown in FIG. 89A , one or more radiopaque markers 1580 can be sewn into the impermeable material 21 at or near any inner fitting 1542 once the proximal portion 1520 is attached to the distal portion 1530. For example, a suture 1560 can be threaded through an aperture 1582 to attach the radiopaque marker 1580 to the impermeable material 21. One or more radiopaque markers 1580 can also be sewn onto the impermeable material 21 at or near the inner fitting 1542 after the proximal portion 1520 is attached to the distal portion 1530 or if the proximal portion 1520 is integrally formed with the distal portion 1530. One or more radiopaque markers 1580 can be attached to the outside of the impermeable material 21 such that the radiopaque markers do not interfere with the valve 29 when the valve 29 is deployed in the valve seat 18. However, one or more radiopaque markers 1580 may also be attached to the interior of the opaque material 21 .

[0206] As shown in Figures 89B-89D, one or more radiopaque markers 1580 can also be disposed in one or more pockets 1586 in or on the opaque material 21. The pocket or pockets can take a wide variety of different forms. The pockets can be formed from a patch of material or by any other manner of forming a pocket. For example, any manner in which a pocket is formed in a fabric can be used in the opaque material 21.

[0207] The one or more pockets 1586 can be sized and shaped to receive one of the radiopaque markers 1580. The pockets 1586 can be generally rectangular or diamond shaped. However, the pockets 1586 can also be triangular, circular, oval, or any other suitable shape. In one embodiment, the pockets 1586 extend radially outward from the remainder of the impermeable member 21. However, the pockets 1586 can alternatively extend radially inward from the remainder of the impermeable material 21. The pockets 1586 can be part of or near the inner joint 1542 of the impermeable material 21. For example, the proximal portion 1520 and the distal portion 1530 can be sized and shaped such that the pockets 1586 are formed when the proximal portion 1520 is attached to the distal portion 1530. The pockets 1586 may be formed from additional material or patches added to the proximal portion 1520 and / or the distal portion 1530, or may be formed from additional impermeable material 21 attached to the area defined by the proximal portion 1520 and / or the distal portion 1530. One or more pockets 1586 may be spaced about the impermeable material 21 at or near the inner fitting 1542 such that when the impermeable material 21 is attached to the frame 1500, the pockets 1586 are disposed around the circumference of the valve seat 18 of the docking station 10.

[0208] The radiopaque marker 1580 can be disposed and secured within the pocket 1586. In one embodiment, the radiopaque marker 1580 is disposed within the pocket 1586 before the opaque material 21 is attached to the frame 1500. The pocket 1586 can then be covered by one or more pocket coverings 1588, and the pocket can be sewn closed and / or stitches can be passed through the radiopaque marker to secure the marker within the pocket. The optional pocket covering 1588 can be sized and shaped to cover the opening of the pocket 1586 and can comprise the same material as the opaque material 21. The pocket covering 1588 can be attached to the opaque material 21 on the side opposite the frame 1500 of the opaque material 21. The pocket covering 1588 can be attached to the opaque material 21 by one or more sutures 1560. The pocket 1586 may alternatively be formed by attaching a pocket covering 1588 to the impermeable material 21 , thereby defining the pocket 1586 as the space between the pocket covering 1588 and the impermeable material 21 .

[0209] 89C and 89D, the sutures 1560 can attach the pocket covering 1588 to the impermeable material 21 around the outside of the pocket covering 1588 and can include support stitches 1589 extending across the pocket covering 1588. The support stitches 1589 can provide a radial force against the valve 29 when the valve 29 is deployed within the valve seat 18. The support stitches 1589 can be along or parallel to the inner fitting 1542 (FIG. 89C) or perpendicular to the inner fitting 1542 (FIG. 89D).

[0210] 89E-89N, a radiopaque marker 1580 having an optional aperture 1582 may be disposed and secured within a pocket 1586 (not shown since the pocket 1586 is formed between a pocket covering 1588 and the opaque member 21) of the opaque member 21. The radiopaque marker 1580 may be secured within the pocket 1586 in a manner that may increase the fixation of the radiopaque marker 1580 and may decrease the translational and rotational movement of the radiopaque marker 1580. As shown in FIG. 89E and FIG. 89F, the pocket covering 1588 may be disposed over the opaque material 21 and partially secured to the opaque material 21 by sutures 1560. The sutures 1560 can be sewn around a portion of the pocket covering 1588 to partially secure the pocket covering 1588 to the impermeable member 21 such that the portion of the pocket covering 1588 is not secured to the impermeable member 21. The sutures 1560 can be threaded through the pocket covering 1588 and the impermeable member 21 at a number of piercing points 1591. The piercing points 1591 can be near the edges of the pocket covering 1588 and can substantially encircle the perimeter of the pocket covering 1588. For example, the sutures 1560 can be threaded through the piercing points 1591 to encircle three-quarters of the perimeter of the pocket covering 1588. In the illustrated embodiment, the sutures 1560 are sewn through the piercing points 1591 with an in and out stitch. However, the sutures 1560 can be sewn through the piercing points 1591 with any suitable stitch.

[0211] As shown in FIG. 89G, the radiopaque marker 1580 can then be placed in a pocket 1586 formed between the opaque material 21 and the pocket covering 1588. The radiopaque marker 1580 can be positioned or oriented such that the aperture 1582 extends between the pocket covering 1588 and the opaque member 21. As shown in FIG. 89H, the remainder of the pocket covering 1588 can be secured to the opaque member 21 by the sutures 1560. The sutures 1560 can be threaded through additional piercing points 1591 such that the sutures 1560 substantially surround the radiopaque marker 1580 near the edges of the pocket covering 1588. The sutures 1560 can be threaded through the pocket covering 1588 and the opaque member 21 such that the sutures 1560 pass through the initial piercing points 1591. Optionally, as shown in FIG. 89H, the suture 1560 can be threaded back through the piercing point 1591 to create an interlocking stitch 1590 similar to the stitches described in FIGS. 82E-82I.

[0212] Although the pocket covering 1588 has been described as being partially sewn to the impermeable member 21 before the radiopaque marker 1580 is placed in the pocket 1586, the pocket covering 1588 can be attached to the impermeable member 21 in other manners. For example, the radiopaque marker 1580 can be disposed between the pocket covering 1588 and the impermeable member 21, and the pocket covering 1588 can then be sewn to the impermeable member 21.

[0213] 89I-89L, the radiopaque marker 1580 may be further secured within the pocket 1586 with cross stitches. The suture 1560 may be sewn from one of the pierce points 1591 to a pierce point 1591 on the opposite side of the pocket covering 1588 and may pass through the pierce point 1591 at the center of the pocket covering 1588. The center pierce point 1591 may be aligned with the aperture 1582 of the radiopaque marker 1580 such that the suture 1560 extends through the aperture 1582 of the radiopaque marker 1580. The additional stitches can be configured such that the suture 1560 extends vertically across the pocket covering 1588 (as shown in FIG. 89I), such that the suture 1560 extends horizontally across the pocket covering 1588 (as shown in FIG. 89J), and / or such that the suture 1560 extends diagonally across the pocket covering 1588 (as shown in FIGS. 89K and 89L).

[0214] As shown in FIGS. 89M and 89N, the radiopaque marker 1580 can be further secured within the pocket 1586 with a second cross stitch. The second cross stitch of the suture 1560 can extend from one of the piercing points 1591 to a piercing point 1591 on the opposite side of the pocket covering 1588 and can pass through the piercing point 1591 at the center of the pocket covering 1588. This second stitch through the central piercing point 1591 can be substantially perpendicular to the first cross stitch across the pocket covering 1588 that extends through the central piercing point 1591. Thus, the suture 1560 can form a "+" or "X" shape across the pocket covering 1588. However, the suture 1560 may be sewn in any configuration to secure the radiopaque marker 1580 within the pocket 1586 and may include more than two stitches extending through the central pierce point 1591.

[0215] 90A-90C, instead of being separate individual pieces attached to the frame 1500 or opaque material 21, one or more radiopaque markers 1580 are included in the frame 1500. The radiopaque markers 1580 can be incorporated into the frame 1500 or the radiopaque markers 1580 can be thicker frame joints 1503 in the valve seat 18 of the frame 1500, thereby increasing the radiopacity or radiodensity of one or more portions of the valve seat 18. For example, in embodiments in which the frame 1500 includes nitinol, additional nitinol can be deposited at the frame joints 1503 in the valve seat 18 to increase the radiopacity or radiodensity of the valve seat 18. However, the radiopacity or radiodensity of the frame joints 1503 in the valve seat 18 can be increased in a variety of other ways, such as by depositing additional and / or different radiopaque material at one or more frame joints 1503 in the valve seat 18.

[0216] Additionally or alternatively, the radiopacity of the valve seat 18 can be increased by using a radiopaque material or a material that increases radiopacity in the opaque material 21. For example, the proximal portion 1520 can include a radiopaque material or a material that increases radiopacity near the first edge 1522 and / or the distal portion 1530 can include a radiopaque material or a material that increases radiopacity near the first edge 1532 such that the radiopacity of the opaque material 21 is increased at or near the inner joint 1542. Further, the suture 1560 used to join the proximal portion 1520 to the distal portion 1530 can include a radiopaque material or a material that increases radiopacity such that the radiopacity of the inner joint 1542 is increased. Therefore, when the opaque material 21 is attached to the frame 1500, the radiopacity of the valve seat 18 of the docking station 10 can be increased.

[0217] Radiopaque markers 1580 or portions of increased radiopacity or radio density, such as by including additional radiopaque material, can be used to facilitate deployment of any of the docking station 10, docking station frame 1500, and / or THV or valve 29 described herein. As shown in FIG. 91, radiopaque markers 1580 or portions of increased radiopacity or radio density of the frame 1500 can be used to allow the THV or valve 29 to be properly deployed within the docking station 10 or docking station frame 1500, such as within the valve seat 18. The valve 29 can be deployed such that a center or central portion of the valve 29 is aligned with the radiopaque marker 1580 of the frame 1500. The radiopaque marker 1580 can be any of the radiopaque markers described herein and can be attached to the frame 1500 at the joint 1503 (FIG. 90A), disposed within a marker setting 1584 (FIG. 88), attached to the opaque material (FIG. 89A), disposed within a pocket 1586 disposed within the opaque material 21 (FIG. 89B), or in any other suitable manner. The valve 29 can be deployed under fluoroscopy or a similar imaging process such that the radiopaque marker 1580 of the deployed frame 1500 is visible. The valve 29 can be constructed or configured to also be visible under fluoroscopy or a similar imaging process. Additionally or alternatively, the valve 29 can include radiopaque markers or portions with increased radiopacity or radiodensity similar to the radiopaque marker 1580 of the frame 1500 described above. For example, the valve 29 may include a radiopaque marker disposed in the center or central portion of the valve 29 .

[0218] During deployment, the valve 29 can be positioned or repositioned such that a center or central portion of the valve 29 rests between and is aligned with the radiopaque markers 1580 of the frame 1500. For example, the valve 29 can be positioned or repositioned such that the radiopaque markers of the center or central portion of the valve 29 are aligned with the radiopaque markers 1580 of the frame. Once the center or central portion of the valve 29 is substantially aligned with the radiopaque markers 1580 in the valve seat 18 of the frame 1500, the valve 29 can be released or deployed such that the valve 29 is deployed in the valve seat 18 of the docking station frame 1500. This alignment of the valve 29 with the valve seat 18 of the docking station frame 1500 can prevent leakage between the valve 29 and the frame 1500.

[0219] Although the frame 1500 has been described as including radiopaque markers 1580 for positioning and repositioning the valve 29 for deployment within the valve seat 18 of the frame 1500, positioning of the valve 29 within the frame 1500 can be by any other suitable manner of position identification. For example, the frame 1500 can include portions of the valve seat 18 that have increased radiopacity or radio density, such as by including thicker frame interfaces 1503 at the valve seat 18, by including additional nitinol at the frame interfaces 1503, by depositing additional and / or different radiopaque material at one or more frame interfaces 1503 of the valve seat 18, or by any other suitable manner.

[0220] 91-96B, radiopaque markers or portions with increased radiopacity or radio density can also be used to deploy the docking station 10 or frame 1500 from a delivery device such as a catheter. As shown in FIGS. 92A-96B, portions of the delivery catheter 3600 can include radiopaque markers or portions with increased radiopacity or radio density that can be seen under fluoroscopy or a similar imaging process and can be used to deploy, position, recapture, and / or redeploy the frame 1500. The elongated nosecone 28 can have increased radiopacity or radiodensity such that at least a portion of the elongated nosecone 28 can be identified under fluoroscopy or a similar imaging process. For example, the elongated nosecone 28 can include at least a portion of barium sulfate to increase the radiopacity of the nosecone 28. However, any material that provides radiopacity can be used.

[0221] As shown in FIGS. 92A-C, the outer tube 4910 of the delivery catheter 3600 has an end or distal end 4911 near the nosecone 28 when the delivery catheter 3600 is in a compact or undeployed state, from which the frame 1500 can be deployed, as described below. The outer tube 4910 can include one or more radiopaque markers 4920 disposed at or near the distal end 4911 that increase the radiopacity or radiodensity at or near the distal end 4911. The radiopaque markers 4920 can be of any suitable size, shape, configuration, or composition, such as any of the sizes, shapes, configurations, and compositions of the radiopaque markers described hereinabove. The radiopaque markers 4920 can be configured and positioned to indicate the amount that the frame 1500 has been deployed, as described in more detail below. Optionally, the outer tube 4910 can include an end cap 4913 disposed at an end of the outer tube 4910. The end cap 4913 can be a ring, such as a plastic ring, at the end of the outer tube 4910, and one or more radiopaque markers 4920 can be disposed on, as part of, or within the end cap 4913. Additionally or alternatively, the end cap 4913 can be constructed of a material with increased radiopacity or radio density such that the end cap 4913 is visible or identifiable under fluoroscopy or a similar imaging process. As shown in FIG. 92B, the proximal end of the nosecone 28 can extend at least partially into the end cap 4913.

[0222] As shown in FIG. 92A and FIG. 92B, the radiopaque marker 4920 can be a single band extending around the outer tube 4910. The band can be continuous (i.e., extending 360° around the tube) or partial (i.e., extending less than 360°). The band can be attached to the outer tube 4910 in a variety of different ways. For example, the band can be embedded in the tube, bonded to the tube surface, or otherwise attached to the tube. The radiopaque marker 4920 can include any suitable material with increased radiopacity or radiodensity, such as platinum iridium, and can be embedded in the end cap 4913. However, the radiopaque marker 4920 can have any suitable size, shape, or configuration. For example, the radiopaque marker 4920 can be disposed around the end cap 4913 or disposed radially inward of the end cap 4913.

[0223] As shown in FIG. 92C, the outer tube 4910 can include a plurality of radiopaque markers 4920 disposed circumferentially around the exterior of the outer tube 4910 near the distal end 4911. The radiopaque markers 4920 can be solid cylindrical disks disposed equidistantly around the outer surface of the end cap 4913. However, the radiopaque marker or markers 4920 can be of any suitable size, shape, or configuration. For example, the radiopaque markers 4920 can be any of the configurations of the radiopaque markers 1580 shown in FIGS. 86A-86D. Additionally, the radiopaque markers 4920 can be disposed on or in any end cap 4913 or outer tube 4910 in any suitable manner. For example, the radiopaque marker 4920 may be embedded within the end cap 4913 or disposed radially inward of the end cap 4913 .

[0224] Although the radiopacity or radiodensity near the distal end 4911 of the outer tube 4910 has been described as being increased by the inclusion of one or more radiopaque markers 4920, the radiopacity or radiodensity may be increased in other manners. For example, the end cap 4913 may at least partially comprise a material having increased radiopacity or radiodensity, or additional and / or different material may be deposited around the distal end 4911 to increase the radiopacity or radiodensity.

[0225] As shown in FIGS. 93A-93C, the outer tube 4910 can be retracted proximally from the nosecone 28. As the outer tube 4910 is retracted, the connecting tube 4916 is exposed. The connecting tube 4916 is disposed between the nosecone 28 and the docking station connector 4914 and is sized to be disposed and movable within the outer tube 4910. In the illustrated embodiment, the outer tube 4910 includes an end cap 4913 having a radiopaque marker 4920 (not shown) embedded therein. However, the outer tube 4910 can include any radiopaque marker or manner of increasing radiopacity or radiodensity. For example, the outer tube 4910 can include a plurality of radiopaque markers 4920 disposed near the distal end 4911, as shown in FIG. 92C.

[0226] The connecting tube 4916 may include one or more radiopaque markers 4922 disposed along the length of the connecting tube 4916 to increase radiopacity or radio density. The one or more radiopaque markers 4922 may be spaced along the connecting tube 4916 at a fixed or predetermined distance from the nosecone 28 and / or the docking station connector 4914 to provide positioning and / or deployment information. The location or positioning of the radiopaque markers 4922 may be selected to indicate or identify an amount of deployment of the frame 1500, as described below. In an exemplary embodiment, the outer tube 4910 includes one or more radiopaque markers, but the connecting tube does not include any radiopaque markers. In an exemplary embodiment, the connecting tube 4916 includes one or more radiopaque markers, but the outer tube 4910 does not include any radiopaque markers. In one exemplary embodiment, the connecting tube 4916 includes one or more radiopaque markers and the outer tube 4910 includes one or more radiopaque markers. Any combination of the nosecone, outer tube, connecting tube, docking station, and valve may include one or more radiopaque markers to aid in deployment of the docking station and / or valve.

[0227] 93A-93C, the connecting tube 4916 includes one radiopaque marker 4922 as a band disposed about the connecting tube 4916. However, the connecting tube 4916 can have any number, positioning, or configuration of radiopaque markers 4922. For example, the connecting tube 4916 can have two radiopaque markers 4922 (FIG. 94) or three or more radiopaque markers 4922 disposed at different lengths along the connecting tube 4916, and the radiopaque markers 4922 can be similar to the radiopaque markers 1580 described in FIGS. 86A-86D. Additionally or alternatively, the connecting tube 4916 can have increased radiopacity or radiodensity by other suitable means. For example, radiopacity or radiodensity of a portion of the connecting tube 4916 can be achieved by depositing additional and / or different radiopaque material along the connecting tube 4916 or by constructing the portion of the connecting tube 4916 at least in part from a highly radiopaque or radiodense material.

[0228] 94, the frame 1500 can be disposed in a compressed or undeployed state along and around the connecting tube 4916 between the nosecone 28 and the docking station connector 4914. The outer tube 4910 can be retracted relative to the nosecone 28, the connecting tube 4916, the docking station connector 4914, the inner tube 4912, and the frame 1500 to deploy the frame 1500. The frame 1500 can be coupled to the catheter assembly or to the docking station connector 4914 of the catheter assembly in a variety of different manners. For example, the frame 1500 can be coupled to the catheter assembly using a lock, a locking mechanism, a suture (e.g., one or more sutures releasably attached, tied, or braided through one or more portions of the docking station), an interlocking device, a combination thereof, or other attachment mechanism. Some of these coupling or attachment mechanisms can be configured to constrain the proximal end of the docking station into a smaller profile or folded configuration, for example, to allow the docking station to be adjusted, removed, repositioned, etc., thereby allowing the frame to be retracted and placed back into the catheter assembly without the frame catching on an edge of the catheter assembly.

[0229] In an exemplary embodiment, the docking station connector 4914 can be configured to at least partially secure or control the frame 1500 during deployment. In the illustrated embodiment, the frame 1500 includes an elongated leg 5000 that can connect the frame 1500 to the docking station connector 4914. The elongated leg 5000 can be a retention portion of the proximal end 12 of the frame 1500 that is longer than the remainder of the retention portion 414. The illustrated elongated leg 5000 includes a head 5636 that can be retained within a T-shaped recess 5710 of the docking station connector 4914 to at least partially connect the frame 1500 to a delivery catheter assembly during deployment of the frame 1500. The head 5636 of the elongated leg 5000 can be secured within the T-shaped recess 5710 when the outer tube 4910 is retracted and the remainder of the frame 1500 expands. Once the remainder of the frame 1500 is deployed, the head 5636 of the elongate leg 5000 can be released from the T-shaped recess 5710. However, the frame 1500 can be connected, coupled, or otherwise secured to the delivery catheter assembly in any other manner, such as any other manner described herein above.

[0230] 94, the frame 1500 can be disposed within the outer tube 4910 and around the connecting tube 4916, with the radiopaque markers 4922 of the connecting tube 4916 disposed along the length of the frame 1500. The radiopaque markers 4922 can be disposed along the connecting tube 4916 to correspond to predetermined points on the frame 1500. The radiopaque markers 4922 can be positioned along the connecting tube 4916 to correspond to various amounts of deployment of the frame 1500, as described below. In the illustrated embodiment, the connecting tube 4916 includes two spaced apart radiopaque markers 4922 disposed along its axial length. However, the connecting tube 4916 can have any number, shape, size, or configuration of radiopaque markers 4922. For example, the connecting tube 4916 can have one radiopaque marker 4922, three or more radiopaque markers 4922, or a single radiopaque marker 4922 that extends a long distance along the length of the connecting tube 4916.

[0231] As shown in FIGS. 95A-C, the outer tube 4910 can be retracted from the remainder of the delivery catheter assembly to expose the frame 1500 for deployment. In the illustrated example, the frame 1500 includes an impermeable member 21 and one or more radiopaque markers 1580 in the valve seat 18 that are exposed as the outer tube 4910 is retracted and the frame 1500 is deployed. The impermeable member 21 can be any suitable covering of the frame 1500. For example, the impermeable member 21 can be similar to any of the impermeable members 21 described herein. The radiopaque markers 1580 of the frame 1500 are visible under fluoroscopy or similar imaging while the radiopaque markers 1580 are disposed within the outer tube 4910. The radiopaque markers 1580 can be disposed on or attached to the frame 1500 in any manner described herein. For example, the radiopaque markers 1580 can be disposed on the joints 1503 of the frame 1500, such as by being disposed in a marker setting 1584 (FIG. 88), attached to an opaque material (FIGS. 89A, 95C), disposed in a pocket 1586 disposed in the opaque member 21 (FIG. 89B), or any other suitable manner. Alternatively, the radiopacity or radiodensity of one or more portions of the valve seat 18 can be increased in any other suitable manner. For example, the frame 1500 can include portions of the valve seat 18 that have increased radiopacity or radiodensity, such as by including a thicker frame joint 1503 at the valve seat 18, by including additional nitinol at the frame joint 1503, by depositing additional and / or different radiopaque material at one or more frame joints 1503 of the valve seat 18, or any other suitable manner.

[0232] The radiopaque marker 1580 on the frame 1500, the one or more radiopaque markers 4920 on the outer tube 4910, the one or more radiopaque markers 4922 on the connecting tube 4916, and / or the radiopaque nose cone 28 can be used to facilitate deployment of the docking station frame 1500 in the correct location, such as the correct location in the pulmonary artery, the correct location in the mitral valve, the correct location in the tricuspid valve, or the correct location in any portion of the vascular system.

[0233] As shown in FIG. 95A, the outer tube 4910 can be retracted or pulled out from the remainder of the delivery catheter assembly such that the distal end 14 of the frame 1500 is no longer housed in the outer tube 4910. The exposed portion of the frame 1500 begins to extend out of the outer tube 4910. As the distal portion of the frame 1500 begins to extend out of the distal end 4911 of the outer tube 4910, the radiopaque marker 1580 of the frame 1500 and one or more radiopaque markers 4922 of the connecting tube 4916 move relatively toward the distal end of the outer tube, but are still disposed within the outer tube 4910. The frame 1500 also remains coupled to the delivery catheter assembly. For example, the heads 5636 of one or more elongated legs 5000 of the frame 1500 can be retained by the docking station connector 4914. In such a position, the deployed portion of the frame 1500 can be recaptured within the outer tube 4910 by advancing the outer tube 4910 distally or by retracting the remainder of the delivery catheter assembly within the outer tube 4910.

[0234] 95B, the outer tube 4910 can be further retracted or pulled from the remainder of the delivery catheter assembly such that the radiopaque marker 1580 in the valve seat 18 of the frame 1500 is substantially aligned with the radiopaque marker 4920 on the distal end 4911 of the outer tube 4910. In such a position, the frame 1500 can be approximately 50% or half deployed from the outer tube 4910. One or more radiopaque markers 4922 on the connecting tube 4916 can remain disposed within the outer tube 4910. The frame 1500 can remain coupled to the delivery catheter assembly, such as with the heads 5636 of the one or more elongated legs 5000 retained by the docking station connectors 4914. In such a position, the outer tube 4910 can be advanced distally such that the deployed portion of the frame 1500 is recaptured within the outer tube 4910, or the remainder of the delivery catheter assembly can be retracted into the outer tube 4910. Alignment of the radiopaque marker 1580 of the frame 1500 with the one or more radiopaque markers 4920 of the outer tube 4910 can indicate at what point the frame 1500 should be deployed in its entirety or recaptured, repositioned, and redeployed from the outer tube 4910. That is, the radiopaque marker 1580 of the frame 1500 and the one or more radiopaque markers 4920 of the outer tube 4910 can be used to determine whether the frame 1500 is properly positioned prior to fully deploying and releasing the frame 1500.

[0235] 95C, the outer tube 4910 can be further retracted or pulled out from the remainder of the delivery catheter assembly. The docking station frame 1500 is extended out of the outer tube 4910, except that one or more elongated legs 5000 can be retained by docking station connectors 4914 in the outer tube 4910. In such a position, it may not be possible to recapture the frame 1500 within the outer tube 4910, but the frame 1500 can be repositioned before it is released from the delivery catheter assembly.

[0236] Once the frame 1500 is in the desired position, the outer tube 4910 can be further retracted to release the frame 1500 from the delivery catheter assembly, such as by releasing the engagement between the elongated legs 5000 and the docking station connector 4914. In the illustrated embodiment, the outer tube 4910 is retracted such that the radiopaque marker 4920 on the distal end 4911 of the outer tube 4910 is proximal to one or more radiopaque markers 4922 on the connecting tube 4916 such that the radiopaque markers 4922 on the connecting tube 4916 are deployed.

[0237] The radiopaque marker 4922 of the connecting tube 4916 and / or the one or more radiopaque markers 4920 of the outer tube 4910 may be spaced apart or positioned in any suitable manner. For example, the radiopaque markers 4922 of the connecting tube 4916 may be spaced apart such that in such a position, one of the radiopaque markers 4922 of the connecting tube 4916 may be positioned on the connecting tube 4916 to be substantially aligned with the radiopaque marker 4920 of the outer tube 4910 (i.e., at a position between the positions shown by FIG. 95B and FIG. 95C). For example, when viewed under fluoroscopy or a similar imaging process, the alignment of one of the radiopaque markers 4922 of the connecting tube 4916 with one of the radiopaque markers 4920 of the outer tube 4910 may indicate a final position in which the frame 1500 may be placed back into the outer tube 4910.

[0238] As shown in Figures 96A and 96B, the radiopaque nose cone 28, the one or more radiopaque markers 4920 on the outer tube 4910, the radiopaque marker 1580 on the frame 1500, and the one or more radiopaque markers 4922 on the connecting tube 4916 are visible under fluoroscopy or other imaging process and can be monitored during deployment of the frame 1500. The frame 1500, the connecting tube 4916, the docking station connector 4914, and the inner tube 4912 are optionally visible under fluoroscopy or a similar imaging process, but are not as obvious as the radiopaque markers. In Figures 96A and 96B, the frame 1500 is shown with dashed lines indicating the position of the frame in the drawing, but indicating that the frame may not be visible under fluoroscopy or may be difficult to see under fluoroscopy.

[0239] The positioning of the radiopaque markers 1580, 4920, 4922 can be monitored to indicate the amount that the frame 1500 has been expanded or deployed. For example, the radiopaque markers 1580, 4920 can be used to position and deploy the frame at a desired location within the vascular system. In addition, the radiopaque markers 4920, 4922 can be used to monitor when the frame 1500 can still be placed back into the outer tube (i.e., when the marker 4920 has not moved distally beyond the marker 4920). For example, the amount of deployment of the frame 1500 indicated by the alignment of the markers 4920, 4922 can represent an amount or degree of deployment that corresponds to a maximum amount of deployment before the frame 1500 cannot be recaptured by the outer tube 4910.

[0240] 96A, before the docking station frame 1500 is deployed from the outer tube 4910, while the delivery catheter assembly is in an undeployed state (FIG. 94), the elongated nosecone 28 can be disposed distal to one or more radiopaque markers 4920 of the outer tube 4910. Prior to deployment, the radiopaque markers 4920 of the outer tube 4910 can be disposed at or near the proximal end of the elongated nosecone 28. The radiopaque marker 1580 of the frame 1500 can be disposed proximal to the radiopaque marker 4920 of the outer tube 4910, and the one or more radiopaque markers 4922 of the connecting tube 4916 can be disposed proximal to the radiopaque marker 1580 of the frame 1500. One or more radiopaque markers 4922 on the connecting tube 4916 may be disposed distal to the docking station connector 4914 .

[0241] During deployment of the frame 1500, the positions of the radiopaque marker 1580 of the frame 1500, the one or more radiopaque markers 4920 of the outer tube 4910, the one or more radiopaque markers 4922 of the connecting tube 4916, and the radiopaque nosecone 28 can be monitored and compared to indicate the extent of deployment of the frame 1500, such as to determine when the frame 1500 is properly expanded and deployed in a desired position. For example, the marker 4920 distal to the outer tube can be positioned substantially at the desired deployment position on the waist of the frame until the radiopaque marker 1580 in the valve seat 18 of the frame 1500 is substantially aligned with the one or more radiopaque markers 4920 of the outer tube 4910, and the docking station frame 1500 can be deployed from the delivery catheter assembly (such as by retracting the outer tube 4910). This positions the waist of the frame, indicated by the marker 1580, in the desired deployment position. In the illustrated example, this alignment results in frame 1500 being approximately halfway or 50% deployed from the outer tube 4910. At such point, the operator can determine that frame 1500 is properly deployed and continue to deploy frame 1500 or recapture, reposition, and redeploy frame 1500 within the outer tube 4910.

[0242] As shown in FIG. 96B, the outer tube 4910 (not shown under fluoroscopy) can be retracted until one or more radiopaque markers 4920 are substantially aligned with one of the radiopaque markers 4922 of the connecting tube 4916. The radiopaque marker 1580 of the frame 1500 can be disposed between the nosecone 28 and the radiopaque marker 4920 of the outer tube 4910, and the frame 1500 can be deployed more than halfway. The position of the radiopaque marker 1580 at the waist of the frame 1500 can be checked to confirm that the frame is in the desired deployment position within the vascular system. The alignment of the radiopaque marker 4920 of the outer tube 4910 and the radiopaque marker 4922 of the connecting tube 4916 can provide an indication to the operator as to the amount the frame 1500 has been deployed. Alignment of the radiopaque markers 4920 of the outer tube 4910 and the radiopaque markers 4922 of the connecting tube 4916 can provide an indication of a desired and / or maximum amount that can still be recaptured within the delivery catheter assembly, such as by expanding or deploying the frame 1500 and advancing the outer tube 4910 distally. This can provide an indication to the operator that the frame 1500 should be deployed or recaptured by the outer tube 4910, such as to reposition and redeploy the frame 1500. For example, alignment of the radiopaque markers 4920 of the outer tube 4910 and the radiopaque markers 4922 of the connecting tube 4916 can indicate that the frame 1500 is 50%-75% deployed, such as 60% deployed. Additionally or alternatively, alignment of one of the radiopaque markers 4920 on the outer tube 4910 and one of the radiopaque markers 4922 on the connecting tube 4916 can indicate when the frame 1500 is fully deployed from the outer tube 4910, except where the elongated leg 5000 is attached to the docking station connector 4914, and / or the desired position where the frame 1500 should be released from the delivery catheter assembly.

[0243] Although the frame 1500 has been described as having a radiopaque marker 1580 disposed within the valve seat 18, the outer tube 4910 has been described as having a radiopaque marker 4920 near the distal end 4911 of the outer tube 4910, and the connecting tube 4916 has been described as having a radiopaque marker 4922 disposed along the axis of the connecting tube 4916 to indicate deployment of the frame 1500, the outer tube 4910, the connecting tube 4916, the frame 1500, and / or any other components of the delivery system can have any suitable configuration of increased radiopaque or radio-dense portions that can provide an indication as to the amount of expansion or deployment of the frame 1500 prior to releasing the frame 1500. For example, the frame 1500 may include a radiopaque marker 1580 at the joint 1503 distal to the valve seat 18 which, when aligned with the radiopaque marker 4920 of the catheter 3600 during deployment of the frame 1500, indicates a desired or maximum amount of expansion and / or deployment of the frame 1500 before the frame 1500 is released from the catheter 3600.

[0244] The above mainly describes an embodiment of a self-expanding docking station. However, the docking station and / or delivery device shown and described herein can be modified for delivery of a balloon-expandable and / or mechanically expandable docking device within the scope of the present disclosure. That is, delivery of a balloon-expandable and / or mechanically expandable docking station to an implantation location can be performed percutaneously using a modified delivery device of the present disclosure. In general terms, this includes providing a transcatheter assembly, which may include a delivery sheath and / or an additional sheath as described above. In the case of a balloon-expandable docking station, the device generally further includes a delivery catheter, a balloon catheter, and / or a guidewire. A delivery catheter used in a balloon-expandable delivery device can define a lumen in which the balloon catheter is received. The balloon catheter, in turn, defines a lumen in which the guidewire is slidably disposed. Furthermore, the balloon catheter includes a balloon fluidly connected to an inflation source. With the docking station mounted on the balloon, the transcatheter assembly is delivered through a percutaneous opening in the subject via the delivery device. Once the docking station is properly positioned, the balloon catheter is manipulated to inflate the balloon, thereby transitioning the docking station to the expanded configuration.

[0245] (Example) In light of the above-mentioned implementations of the disclosed subject matter, the present disclosure provides additional implementations, which are described below. It should be noted that any independent feature of an embodiment, or more than one combined feature of an embodiment, and optionally, a combination with one or more features of one or more additional embodiments, are still further embodiments within the scope of the disclosure of this application.

[0246] Example 1 A docking station for a medical device, comprising: a frame having a plurality of compression members extending from a proximal end to a distal end and defining a plurality of cells and a valve seat; a plurality of radiopaque markers disposed around the valve seat; and an opaque material attached to the valve seat.

[0247] Example 2 The docking station of any embodiment herein, particularly embodiment 1, wherein the frame includes a plurality of marker settings, each configured to receive one of the radiopaque markers.

[0248] Example 3 The docking station of any embodiment herein, particularly embodiments 1-2, wherein a plurality of radiopaque markers are attached to the opaque material.

[0249] Example 4 The docking station of any embodiment herein, particularly embodiments 1-3, wherein the radiopaque markers are each disposed within a pocket of opaque material.

[0250] Example 5 The docking station of any embodiment herein, particularly embodiments 1-4, wherein each of the radiopaque markers includes an aperture extending through a central portion of the radiopaque marker.

[0251] Example 6 The docking station of any embodiment herein, particularly embodiment 5, wherein a radiopaque marker is attached to the opaque member through the aperture.

[0252] Example 7 The docking station of any embodiment herein, particularly embodiments 1-6, wherein a radiopaque marker indicates a deployment location of the transcatheter heart valve.

[0253] Example 8 The docking station of any of the embodiments herein, particularly embodiments 1-7, wherein the frame includes a plurality of marker settings, each configured to receive one of the radiopaque markers.

[0254] Example 9 The docking station of any embodiment herein, particularly embodiments 1-8, wherein the frame further comprises a plurality of effusion cells.

[0255] Example 10 The docking station of any embodiment herein, particularly embodiments 1-9, wherein the compression member within the valve seat has a greater cross-sectional width than the remaining compression members.

[0256] Example 11 The docking station of any embodiment herein, particularly embodiments 1-10, wherein the impermeable member is attached to the frame by a coating material.

[0257] Example 12 The docking station of any embodiment herein, particularly embodiments 1-11, wherein radiopaque markers are attached to a plurality of joints of the frame.

[0258] (Example 13) A docking station for a medical device comprising: a frame having a proximal end and a distal end, a valve seat, a plurality of stages of compression material extending from the proximal end to the distal end, the compression material defining a plurality of cells, a plurality of joints, and a plurality of apexes at the proximal end and the distal end, a plurality of eyelets at at least one apex of the proximal end and the distal end, and an impermeable material attached to the frame.

[0259] Example 14 The docking station of any embodiment herein, particularly embodiment 13, wherein the impermeable material is attached to the frame by a plurality of vertical stitches.

[0260] Example 15 The docking station of any embodiment herein, particularly embodiments 13-14, wherein the frame comprises four stages of compression members.

[0261] Example 16 The docking station of any embodiment herein, particularly embodiments 13-14, wherein the frame comprises six stages of compression members.

[0262] (Example 17) The docking station of any embodiment herein, particularly embodiments 13-16, wherein the frame comprises 12 vertices at the proximal end.

[0263] (Example 18) The docking station of any embodiment herein, particularly embodiments 13-16, wherein the frame comprises 14 vertices at the distal end.

[0264] (Example 19) The docking station of any embodiment herein, particularly embodiments 13-18, wherein the frame further comprises a plurality of uncoated effusion cells.

[0265] (Example 20) 1. A docking station for a medical device comprising: a frame having a proximal end and a distal end, a valve seat, a plurality of stages of compression material extending from the proximal end to the distal end, and a plurality of apexes at the proximal end and the distal end; an impermeable material having a proximal portion having a first edge, a distal portion having a second edge, and a stitch connecting the proximal portion to the distal portion near the first edge and the second edge, wherein the stitch increases the radial strength of the docking station of the valve seat.

[0266] Example 21 The docking station of any embodiment herein, particularly embodiment 20, further comprising a plurality of radiopaque markers attached to the opaque material.

[0267] Example 22 The docking station of any of the embodiments herein, particularly embodiments 20-21, further comprising a plurality of radiopaque markers, each radiopaque marker disposed within a pocket of the opaque member.

[0268] (Example 23) The docking station of any embodiment herein, particularly embodiments 20-22, wherein the impermeable material is attached to the frame by a coating material.

[0269] Example 24 A docking station for a medical device comprising a frame having a proximal end and a distal end, a valve seat, a plurality of stages of compression material extending from the proximal end to the distal end, a plurality of outflow cells near one of the proximal end and the distal end, and an impermeable material attached to the frame, wherein at least a portion of the outflow cells are not covered by the impermeable material such that blood can flow through the outflow cells.

[0270] (Example 25) The docking station of any embodiment herein, particularly embodiment 24, wherein the effusion cell forms part of the permeable portion of the docking station.

[0271] (Example 26) The docking station of any embodiment herein, particularly embodiment 25, further comprising a plurality of cells defined by a plurality of compression members, the outflow cells being larger than the cells defined by the plurality of compression members.

[0272] Example 27 The docking station of any embodiment herein, particularly embodiments 24-26, wherein the cell closest to the distal end comprises an eyelet.

[0273] (Example 28) The docking station of any embodiment herein, particularly embodiments 24-27, wherein each outflow cell is defined in part by an outflow compression member.

[0274] (Example 29) The docking station of any embodiment herein, particularly embodiments 24-28, wherein each effluent cell comprises a narrow end.

[0275] (Example 30) A docking station for a medical device comprising a frame having a proximal end and a distal end, a valve seat, a plurality of stages of compression members extending from the proximal end to the distal end and defining a plurality of cells, and an impermeable material attached to the frame, wherein the compression members in the valve seat are thicker than other compression members in the frame.

[0276] (Example 31) The docking station of any embodiment herein, particularly embodiment 30, wherein the impermeable material comprises a non-elastic waistband.

[0277] Example 32 The docking station of any of the embodiments herein, particularly embodiments 30-31, further comprising a plurality of radiopaque markers disposed within the valve seat.

[0278] (Example 33) The docking station of any embodiment herein, particularly embodiments 30-32, further comprising a plurality of apexes at the proximal and distal ends.

[0279] (Example 34) The docking station of any embodiment herein, particularly embodiment 33, further comprising a plurality of eyelets near the apex of the proximal end.

[0280] Example 35 A docking station for a medical device comprising: a frame having a proximal end and a distal end, a valve seat, a plurality of sections of compression material extending from the proximal end to the distal end defining a plurality of cells, and a plurality of apexes at the proximal end and the distal end; and an impermeable material, wherein a portion of the cells near the distal end are not covered by the impermeable material.

[0281] (Example 36) The docking station of any embodiment herein, particularly embodiment 35, wherein the frame further comprises a plurality of openings near the proximal and distal ends, and the openings near the distal end are not covered by an impermeable material.

[0282] (Example 37) The docking station of any embodiment herein, particularly embodiments 35-36, wherein the opening near the proximal end is not covered by an impermeable member.

[0283] (Example 38) The docking station of any of the embodiments herein, particularly embodiments 35-37, wherein the impermeable material comprises a proximal portion and a distal portion.

[0284] (Example 39) The docking station of any of the embodiments herein, particularly embodiments 35-38, wherein when the docking station is deployed, blood is able to flow between the impermeable material and the compressible material near the distal end.

[0285] (Example 40) A docking station for a medical device comprising a frame having a proximal end and a distal end, a valve seat, a plurality of stages of compression material extending from the proximal end to the distal end and defining a plurality of cells, a plurality of apexes at the proximal end and the distal end, and an impermeable material configured to be attached to the frame, wherein the impermeable material is attached to the frame by a deposited coating.

[0286] (Example 41) The docking station of any embodiment herein, particularly embodiment 40, wherein the impermeable material comprises a proximal portion and a distal portion, the proximal portion attached to the distal portion forming a non-elastic waist band.

[0287] (Example 42) The docking station of any embodiment herein, particularly embodiments 40-41, further comprising a plurality of radiopaque markers disposed within the valve seat.

[0288] (Example 43) The docking station of any of the embodiments herein, particularly embodiment 42, wherein the radiopaque markers are disposed within a plurality of pockets of the opaque material.

[0289] (Example 44) 1. A medical device comprising: a frame having a proximal end and a distal end, a valve seat, a plurality of sections of compression material extending from the proximal end to the distal end and defining a plurality of cells; and an impermeable member comprising a plurality of pockets circumferentially disposed about the impermeable member and a radiopaque marker disposed within each of the pockets, wherein when the impermeable member is attached to the frame, the pockets are disposed within the valve seat.

[0290] (Example 45) The medical device of any embodiment herein, particularly embodiment 44, wherein the pocket is rectangular.

[0291] (Example 46) The medical device of any embodiment herein, particularly embodiment 45, wherein the pocket extends radially outward from the remainder of the impermeable member.

[0292] (Example 47) The medical device of any embodiment herein, particularly embodiment 45, further comprising a plurality of pocket coverings, one of the pocket coverings covering each of the pockets.

[0293] (Example 48) The medical device of any of the embodiments herein, particularly embodiment 47, wherein each of the radiopaque markers comprises an aperture extending through a central portion of the radiopaque marker.

[0294] (Example 49) A medical device of any of the embodiments herein, particularly embodiment 48, wherein each pocket covering is secured to the remainder of the opaque member by a stitch extending through an aperture of one of the X-ray opaque markers.

[0295] (Example 50) A system comprising: a tube having one or more radiopaque markers; and a docking station frame disposed within the tube, the docking station including one or more radiopaque markers, and a position of the one or more radiopaque markers of the docking station relative to the radiopaque markers of the tube indicates an amount of deployment of the docking station from the tube.

[0296] (Example 51) The system of any of the embodiments herein, particularly embodiment 50, wherein the radiopaque marker of the tube is disposed at or near the distal end of the tube.

[0297] (Example 52) The system of any embodiment herein, particularly embodiment 50, wherein the docking station frame is deployed by retracting the tube proximally relative to the docking station.

[0298] (Example 53) The system of any of the embodiments herein, particularly embodiments 50-52, wherein the one or more radiopaque markers of the tube are radiopaque bands embedded in the tube.

[0299] (Example 54) The system of any of the embodiments herein, particularly embodiments 50-53, wherein the docking station frame includes a plurality of radiopaque markers arranged around the valve seat of the docking station frame.

[0300] (Example 55) The system of any of the embodiments herein, particularly embodiments 50-54, wherein alignment of one of the radiopaque markers of the tube and the radiopaque marker of the docking station frame indicates the amount of deployment of the docking station frame.

[0301] (Example 56) A method of deploying a docking station frame, comprising: positioning a radiopaque marker on the docking station frame at a target location for deploying a valve seat of the docking station frame; deploying a portion of the docking station frame from the tube such that the radiopaque marker on the tube is substantially aligned with the radiopaque marker on the docking station frame; visually confirming that the radiopaque marker on the tube and the radiopaque marker on the docking station frame are in the target location; and further deploying and releasing the docking station frame from the tube.

[0302] (Example 57) The method of any embodiment herein, particularly embodiment 56, wherein the radiopaque marker of the tube is disposed at or near the distal end of the tube.

[0303] (Example 58) The method of any of the embodiments herein, particularly embodiments 56-57, wherein the position of the radiopaque marker of the docking station relative to the radiopaque marker of the tube indicates the amount of deployment of the docking station from the tube.

[0304] (Example 59) The method of any of the embodiments herein, particularly embodiments 56-58, wherein the docking station frame is deployed by retracting the tube proximally relative to the docking station.

[0305] (Example 60) The method of any of the embodiments herein, particularly embodiments 56-59, wherein the docking station frame includes a plurality of radiopaque markers disposed about the valve seat of the docking station frame.

[0306] (Example 61) 1. A system comprising: a delivery catheter assembly comprising: an outer tube having a distal end and one or more radiopaque markers disposed at or near the distal end; a connecting tube having one or more radiopaque markers disposed within the outer tube; and a docking station frame disposed within the outer tube and coupled to the connecting tube, wherein the docking station frame is deployed by retracting the outer tube proximally relative to the connecting tube, and a position of the one or more radiopaque markers of the connecting tube relative to the one or more radiopaque markers of the outer tube indicates an amount of deployment of the docking station from the outer tube.

[0307] (Example 62) The system of any of the embodiments herein, particularly embodiment 61, wherein the one or more radiopaque markers of the outer tube are radiopaque bands embedded in the outer tube.

[0308] (Example 63) The system of any of the embodiments herein, particularly embodiments 61-62, wherein the frame includes a plurality of radiopaque markers arranged around the valve seat.

[0309] (Example 64) The system of any of the embodiments herein, particularly embodiment 63, wherein alignment of one of the radiopaque markers of the outer tube and the radiopaque marker of the frame indicates the amount of deployment of the frame.

[0310] (Example 65) The system of any of the embodiments herein, particularly embodiments 61-64, wherein the connecting tube includes a plurality of radiopaque markers disposed along the length of the connecting tube.

[0311] (Example 66) The system of any of the embodiments herein, particularly embodiments 61-65, wherein alignment of one or more of the radiopaque markers on the outer tube and one or more of the radiopaque markers on the connecting tube indicates the amount of deployment of the frame.

[0312] (Example 67) A system of any of the embodiments herein, particularly embodiments 61-66, wherein alignment of one or more of the radiopaque markers on the outer tube and one or more of the radiopaque markers on the connecting tube indicates a release point of the frame.

[0313] (Example 68) A system of any of the embodiments herein, particularly embodiments 61-67, wherein the frame is configured to be recaptured by the outer tube at any point before one of the radiopaque markers of the outer tube moves proximally beyond one of the radiopaque markers of the connecting tube.

[0314] (Example 69) A method of deploying a docking station frame, comprising: deploying a portion of the docking station frame together with the connecting tube from the outer tube such that a radiopaque marker on the outer tube approaches a radiopaque marker on the connecting tube, wherein substantial alignment of the radiopaque marker on the outer tube with the radiopaque marker on the connecting tube indicates a final point at which the docking station frame can be recaptured by the outer tube.

[0315] (Example 70) The method of any embodiment herein, particularly embodiment 69, further comprising releasing the docking station frame from the tube.

[0316] (Example 71) The method of any of the embodiments herein, particularly embodiments 69-70, wherein the radiopaque marker of the outer tube is disposed at or near the distal end of the outer tube.

[0317] (Example 72) The method of any of the embodiments herein, particularly embodiments 69-71, wherein the position of the radiopaque marker of the docking station relative to the radiopaque marker of the outer tube indicates the amount of deployment of the docking station from the outer tube.

[0318] (Example 73) The method of any of the embodiments herein, particularly embodiments 69-72, wherein the docking station frame is deployed by retracting the outer tube proximally relative to the docking station.

[0319] (Example 74) The method of any of the embodiments herein, particularly embodiments 69-73, wherein the docking station frame includes a plurality of radiopaque markers disposed about the valve seat of the docking station frame.

[0320] (Example 75) a docking station connector movable within the outer tube; and a connecting tube including one or more radiopaque markers disposed within the outer tube and between the elongated nosecone and the docking station connector; and a docking station frame disposed within the outer tube and coupled to the docking station connector, the docking station frame including the one or more radiopaque markers, the docking station frame being deployed by retracting the outer tube proximally from the elongated nosecone, the radiopaque markers on the outer tube, the radiopaque markers on the connecting tube, and the radiopaque markers on the docking station frame being configured to visualize proper placement of the docking station frame and a final point at which the docking station frame can be recaptured by the outer tube.

[0321] (Example 76) The system of any of the embodiments herein, particularly embodiment 75, wherein the one or more radiopaque markers of the outer tube are radiopaque bands embedded in the outer tube.

[0322] (Example 77) The system of any of the embodiments herein, particularly embodiments 75-76, wherein the frame includes a plurality of radiopaque markers arranged around the valve seat.

[0323] (Example 78) The system of any of the embodiments herein, particularly embodiments 75-77, wherein alignment of one of the radiopaque markers of the outer tube and the radiopaque marker of the frame indicates the amount of deployment of the frame.

[0324] (Example 79) The system of any of the embodiments herein, particularly embodiments 75-78, wherein alignment of one or more of the radiopaque markers on the outer tube and the radiopaque markers on the connecting tube indicates the amount of deployment of the frame.

[0325] (Example 80) A system of any of the embodiments herein, particularly embodiments 75-79, wherein alignment of one or more of the radiopaque markers on the outer tube and the radiopaque markers on the connecting tube indicates a release point of the frame.

[0326] (Example 81) A system of any of the embodiments herein, particularly embodiments 75-80, wherein the frame is configured to be recaptured by the outer tube at any point before one of the radiopaque markers of the outer tube moves proximally beyond one of the radiopaque markers of the connecting tube.

[0327] (Example 82) 1. An assembly comprising: a frame having a valve seat and a plurality of radiopaque markers disposed about the valve seat; an elongated nosecone at a distal portion of the assembly; an outer tube having a distal end and one or more radiopaque markers disposed at or near the distal end; a docking station connector movable within the outer tube; and a connecting tube disposed between the elongated nosecone and the docking station connector, wherein the frame is deployed by retracting the outer tube proximally from the elongated nosecone.

[0328] (Example 83) The assembly of any embodiment herein, particularly embodiment 82, wherein the connecting tube further comprises one or more radiopaque markers disposed along the length of the connecting tube.

[0329] (Example 84) The assembly of any of the embodiments herein, particularly embodiments 82-83, wherein alignment of one or more radiopaque markers on the outer tube with the radiopaque markers on the frame or one of the radiopaque markers on the connecting tube indicates the amount of deployment of the frame.

[0330] (Example 85) The assembly of any embodiment herein, particularly embodiments 82-84, wherein the amount of deployment shown is the maximum amount that is deployed before the frame is recaptured by the outer tube.

[0331] (Example 86) The assembly of any of the embodiments herein, particularly embodiments 82-85, wherein a radiopaque marker on the frame indicates the deployment location of the transcatheter valve.

[0332] (Example 87) The assembly of any of the embodiments herein, particularly embodiments 82-86, wherein the elongated nose cone is radiopaque.

[0333] (Example 88) A docking station for a medical device, comprising: a frame having a plurality of compression members extending from a proximal end to a distal end and defining a plurality of cells and a valve seat; an opaque material attached to the frame; and a radiopaque suture disposed around the opaque material.

[0334] (Example 89) The docking station of any embodiment herein, particularly embodiment 88, wherein a radiopaque suture is disposed around the valve seat.

[0335] (Example 90) A docking station of any of the embodiments herein, particularly embodiments 88-89, wherein a radiopaque suture is at least partially disposed around one of the multiple compression members of the frame.

[0336] (Example 91) The docking station of any of the embodiments herein, particularly embodiments 88-90, wherein a radiopaque suture indicates the deployment location of the transcatheter heart valve.

[0337] (Example 92) The docking station of any of the embodiments herein, particularly embodiments 88-91, further comprising a plurality of radiopaque markers.

[0338] (Example 93) The docking station of any of the embodiments herein, particularly embodiment 92, wherein a radiopaque marker is attached to the frame.

[0339] In view of the many possible embodiments to which the principles of the disclosed invention may be applied, it should be recognized that the illustrated embodiments are merely preferred examples of the invention and should not be understood as limiting the scope of the invention. All combinations or subcombinations of the features of the exemplary embodiments described above are contemplated by this application. The scope of the invention is defined by the following claims. We therefore claim as our invention all that comes within the scope and spirit of these claims. [Explanation of symbols]

[0340] 10 Docking Station 12 Proximal end 14 Distal end 18 Valve seat 20 Bands 21 Impermeable materials 29 Valves 194 Stabilizing Bar 210 areas 212 areas 410 Sealing part 414 Retention part 416 Inner surface 510 External surface 512 Inner surface 602 Blood flow direction, arrow 608 Space, blood 710 Radial outward force 712 frames 720 Radial outward force 722 Radial outward force 750 curve 752 areas 754 area 760 Pulmonary artery branch 900 Arrows 912 Solid Area 1100 Arrow 1102 First half 1104 Second half 1106 Distal end 1108 Proximal end 1110 Distal end 1400 Transparent part 1402 Transparent part 1404 Opaque part 1420 area 1500 frames 1502 Metal compression members 1504 Cell 1510 End, apex 2000 parts 2020 Arrow 2100 area 2130 area 2132 Arrow 2300 Vascular 2302 Vascular 2700 frames 2716 Narrow part 3132 Arrow 3202 Arrow 3208 Space 3400 Arrow 3512 Solid Area 3600 Catheter 4500 Trileaflet valve 4910 Outer tube, sleeve 4912 Inner tube, sleeve 4914 Docking Station Connector 4916 Connection tube 5000 Extension, long thin leg 5002 Guidewire 5110 Distal end 5112 Base portion, proximal end 5200 lumen 5308 Incline 5310 Shelf 5500 Meal section 5600 Inside 5636 Head 5638 Straight section 5640 Side 5702 points 5704 points 5710 Depression 5800 Handle 5810 Housing 5812 Driving member 5814 Driven parts 5816 Arrow 5818 Arrow 5820 Depression 5822 Protrusion 5830 Engagement part 5840 Linear recess 5842 Linear protrusion 5850 Female thread 5852 Male thread 5860 Depression 5862 Lure Port 6000 Arrows 6002 Arrow 6200 Handle 6210 Housing 6212 Driving member 6214 Driven parts 6216 Arrow 6218 Arrow 6230 Engagement part 6240 Protrusion 6242 Recesses, linear grooves 6250 Pinion Gear 6252 Rack gear part 6348 Gap, Space 6354 Aperture 6360 Arrow 6370 Arrow 6390 Opening 6800 Ratchet mechanism 6810 Protrusion 6812 Stopping surface 6814 Slope 6822 Axle 6850 Withdrawal direction 6852 Forward direction 6870 Side 6892 Ratchet Arm AV aortic valve CS Coronary sinus F force H Heart IVC Inferior vena cava LA Left atrium LV left ventricle MV Mitral valve P Pressure PA pulmonary artery PV Pulmonary valve RA right atrium RV right ventricle SVC Superior vena cava TV Tricuspid Valve α angle β angle

Claims

1. a proximal end and a distal end; A valve seat; a plurality of sections of compression members extending from the proximal end to the distal end; a frame comprising: a plurality of apexes at said proximal end and said distal end; a proximal portion having a first edge; a distal portion having a second edge; a stitch connecting the proximal portion to the distal portion near the first edge and the second edge; A docking station for a medical device, wherein the stitching increases the radial strength of the valve seat station.

2. The docking station of claim 1 , further comprising a plurality of radiopaque markers attached to the opaque material.

3. a plurality of radiopaque markers; The docking station of claim 1 or 2, wherein each radiopaque marker is disposed within a pocket of the opaque material.

4. The docking station of claim 1 , wherein the impermeable material is attached to the frame by a coating material.

5. A docking station as described in claim 2 or 3, wherein the frame includes a plurality of marker settings, each configured to receive one of the radiopaque markers.

6. A docking station as described in claim 2 or 3, wherein each of the radiopaque markers includes an aperture extending through a central portion of the radiopaque marker.

7. A docking station as described in claim 6, wherein the X-ray opaque marker is attached to the opaque material through the aperture.

8. A docking station as described in any one of claims 2, 3 and 5 to 7, wherein the radiopaque marker indicates the deployment position of a transcatheter heart valve.

9. A docking station as described in any one of claims 2, 3 and 5 to 8, wherein the frame includes a number of marker settings, each configured to receive one of the X-ray opaque markers.

10. A docking station as described in any one of claims 1 to 9, wherein the frame further comprises a plurality of outflow cells.

11. A docking station as described in any one of claims 1 to 10, wherein the compression members within the valve seat have a larger cross-sectional width than the remaining compression members.

12. A docking station as described in any one of claims 2, 3 and 5 to 9, wherein the X-ray opaque marker is attached to multiple joints of the frame.

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