Device and system for docking heart valve

Abstract

To provide an expandable docking station for an improved expandable valve, a catheter for the expandable docking station, and a handle for the catheter.SOLUTION: An expandable docking station for docking an expandable valve can include a valve seat, one or more sealing portions, and / or one or more retaining portions. The valve seat can include radiopaque markers affixed to a frame or an impermeable member. The radiopaque markers can indicate a deployment location of the valve. The docking station can be deployed from a catheter including one or more radiopaque markers. Relative positioning of two or more radiopaque markers can provide an indication of the extent of deployment of the docking station.SELECTED DRAWING: Figure 15A

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of U.S. Provisional Application No. 62 / 991,687, filed Mar. 19, 2020, and U.S. Provisional Application No. 63 / 137,619, filed Jan. 14, 2021, the entire contents of which are hereby incorporated by reference herein.

[0002] The present disclosure relates to heart valves, and more particularly to docking stations / stents, delivery systems, and methods used for implanting heart valves, such as transcatheter heart valves (''THVs'').

Background Art

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

[0004] Transcatheter techniques can also be used, which are less invasive than open - heart surgery, to introduce and implant an artificial heart valve using a flexible catheter. In this technique, the artificial valve can be attached to the end portion of a flexible catheter in a folded state and advanced through the subject's blood vessels until the valve reaches the implantation site. Then, the valve at the catheter tip can be expanded to its functional size at the site of the defective natural valve, for example, by inflating a balloon to which the valve is attached. Alternatively, the valve can have an elastic self - expanding stent or frame such that advancing the valve from a delivery sheath at the distal end of the catheter causes the valve to expand to its functional size.

[0005] A transcatheter heart valve (THV) can be appropriately sized to be placed inside most native aortic valves. However, when the native valve, blood vessel, and graft are large, the transcatheter aortic valve may be too small to fit snugly into the large implantation or deployment site. In this case, the transcatheter valve may not be large enough to fully expand inside the native valve or other implantation or deployment site to be fixed in place.

[0006] Replacement of the pulmonary valve, sometimes referred to as the pulmonic valve, presents significant challenges. The geometry of the pulmonary artery can vary greatly from patient to patient. Generally, the pulmonary artery outflow tract after corrective surgery is too wide to effectively place an artificial heart valve.

Prior Art Documents

Patent Documents

[0007]

Patent Document 1

Patent Document 2

Patent Document 3

Patent Document 4

Patent Document 5

Patent Document 6

Patent Document 7

Patent Document 8

Summary of the Invention

Means for Solving the Problems

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

[0009] In an exemplary embodiment, a docking station for a medical device includes a frame, a plurality of radiopaque markers, and an impermeable material. The frame has a plurality of compression members extending from a proximal end to a distal end. The compression members define a plurality of cells and valve seats. The radiopaque markers are disposed around the valve seats. The impermeable material is attached to the frame.

[0010] In an exemplary embodiment, a 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. The position of the one or more radiopaque markers of the docking station relative to the radiopaque markers of the tube indicates the amount of deployment of the docking station from the tube.

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

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

[0013] In one exemplary method of deploying a docking station frame, a portion of the docking station frame is deployed from the outer tube together with the connection tube such that the radiopaque marker of the outer tube is brought closer by the radiopaque marker of the connection tube. The alignment of the radiopaque marker of the outer tube and the radiopaque marker of the connection tube indicates the final point at which the docking station frame is capturable by the outer tube.

[0014] In an exemplary embodiment, the system comprises a delivery catheter assembly and a docking station frame. The delivery catheter assembly includes an elongate nose cone, an outer tube, a docking station connector, and a connection 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 connection tube is disposed within the outer tube. The connection tube includes one or more radiopaque markers disposed between the elongate nose cone and the docking station connector. The docking station frame is disposed within the outer tube and is coupled to the docking station connector. The docking station frame includes one or more radiopaque markers. The docking station frame is deployed by retracting the outer tube proximally from the elongate nose cone. The radiopaque markers of the outer tube, the radiopaque markers of the connection tube, and the radiopaque markers of the docking station frame are configured to visually determine one or more of the proper placement of the docking station frame and the final location at which the docking station frame is recapturable by the outer tube.

[0015] In an exemplary embodiment, the assembly includes a frame, an elongate nose cone, an outer tube, a docking station connector, and a connection tube. The frame has a valve seat and a plurality of radiopaque markers disposed around 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 connection tube is disposed between the elongate nose cone and the docking station connector. The frame is deployed by retracting the outer tube proximally from the elongate nose cone.

[0016] The various embodiments and methods described herein can be utilized within a subject in a variety of procedures, including but not limited to medical and training procedures. Subjects include, but are not limited to, medical patients, diseased animals, animal models, cadavers, and cardiovascular simulators (e.g., human phantoms and artificial cultured tissues).

[0017] The various features as described anywhere in this disclosure can be included in the examples outlined herein, and various methods and steps using the examples and features, including those as described anywhere in this specification, can be used.

[0018] A further understanding of the nature and advantages of the disclosed invention can be obtained from the following description and claims, particularly when considered in conjunction with the accompanying drawings. In the drawings, like parts have like reference numerals.

[0019] To further clarify the various aspects of the embodiments of the present disclosure, specific embodiments will be described in more detail by referring to the various aspects of the accompanying drawings. It is recognized that these drawings depict only typical embodiments of the present disclosure and thus are not to be considered as limiting the scope of the present disclosure. Further, 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]

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Mode for Carrying Out the Invention

[0021] The following description refers to the accompanying drawings showing specific 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 zone 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 within the pulmonary artery, but the docking station (e.g., docking station 10) can be used in other regions of the anatomical structure, heart, or vasculature, such as the superior vena cava or inferior vena cava. The docking stations described herein can be configured to complement the fact that the deployed THV is smaller than the space (e.g., anatomical structure / vasculature / others) within which the THV is disposed.

[0022] The prostheses including the docking station may be used in various subjects and procedures. Subjects include, but are not limited to, medical patients, diseased livestock, animal models, cadavers, and cardiovascular simulators (e.g., human phantoms and artificial cultured tissues). Procedures include, but are not limited to, medical procedures and training procedures.

[0023] Various embodiments of the docking station and system for delivery and implantation are disclosed herein, and it should be noted that their options can be combined in any way as long as they are not specifically excluded. For example, even if a particular combination is not explicitly described, any of the disclosed docking station devices can be used with any type of valve and / or any delivery system. Similarly, even if not explicitly disclosed, different structures of the docking station and valve can be mixed and coordinated by combining, for example, any type / feature of the docking station, type / feature of the valve, tissue cover, etc. Briefly, the individual components of the disclosed system can be combined as long as they are not mutually exclusive or physically impossible for other reasons.

[0024] For the sake of uniformity, in these drawings and elsewhere in this application, the docking station is depicted with the pulmonary artery branch side end up and the ventricular side end down. These directions may also be referred to as "distal" as a synonym for the upper side or the pulmonary artery branch side end, and "proximal" as a synonym for the lower side or the ventricular side end, and these are terms from the perspective of a physician.

[0025] Figures 1A and 1B are cutaway views of a human heart H during diastole and systole, respectively. The right ventricle RV and the left ventricle LV are separated from the right atrium RA and the left atrium LA by the tricuspid valve TV and the mitral valve MV, respectively, i.e., the atrioventricular valves. 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 valve leaflets that extend inwardly across their respective orifices and that become integral or "join" in the flow to form a one-way fluid occluding surface. For the docking station and valve of the present application, the description will mainly relate to the pulmonary valve. Accordingly, the anatomical structure of the right atrium RA and the right ventricle RV will be described in more detail. The devices described herein can be used, for example, in the inferior vena cava and / or the superior vena cava as treatment for a defective tricuspid valve, in the aorta as treatment for a defective aortic valve (e.g., aortic hypertrophy), in other regions of the heart or vasculature, such as with a graft, or in other regions.

[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 from below. The coronary sinus CS is a collection of veins that join together to form large vessels that collect deoxygenated blood from the heart muscle (myocardium) and deliver it to the right atrium RA. During diastole or ventricular dilation, as seen in FIG. 1A, the venous blood that collects in the right atrium RA enters the tricuspid valve TV due to the dilation of the right ventricle RV. During systole or ventricular contraction, as seen in FIG. 1B, the right ventricle RV contracts and pumps the venous blood through the pulmonary valve PV and into the lungs. In an exemplary embodiment, the devices described by the present application are used to replace or supplement the function of a defective pulmonary valve. During ventricular contraction, the valve leaflets of the tricuspid valve TV close to prevent the backflow of venous blood and its return to the right atrium RA.

[0027] Referring to FIGS. 2A-2E and FIGS. 3A-3D, the illustrative non-exhaustive examples show that the pulmonary artery can have a wide variety of different shapes and sizes. For example, as shown in the cross-sectional views of FIGS. 2A-2E and the perspective views of FIGS. 3A-3D, the length L, diameter D, and curvature or profile can vary significantly between the pulmonary arteries of different patients. Further, 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 are affected by a particular disease and / or have been damaged by past surgery. For example, treatment of tetralogy of Fallot (TOF) or transposition of the great arteries (TGA) often results in a larger and more irregularly shaped pulmonary artery.

[0028] Tetralogy of Fallot (TOF) is a heart anomaly that refers to a combination of four related heart defects that commonly occur together. The four defects are ventricular septal defect (VSD), overriding aorta (the aortic valve is enlarged and appears to exit from both the left and right ventricles rather than from the left ventricle as in a normal heart), pulmonary stenosis (narrowing of the pulmonary valve and the outflow tract or outflow region below the valve, which causes 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 that occurs when the right ventricle pumps against high pressure).

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

[0030] For the surgical treatment of some diseases, it is necessary to make 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 stenosis or constrictive diseases of the pulmonary artery PA associated with other surgeries. However, the impairment or elimination of the pulmonary valve PV may cause significant regurgitation, and before the present invention, it was often necessary to perform a thoracotomy later to replace the pulmonary valve. The transannular patch technique can result in pulmonary arteries having a wide variety of sizes and shapes (see FIGS. 3A - 3D).

[0031] Referring to FIGS. 4A - 4F, in an exemplary embodiment, the expandable docking station 10 includes one or more sealing portions 410, a valve seat 18, and one or more securing portions 414. The sealing portion 410 provides a seal between the docking station 10 and the inner surface 416 of the circulatory system. The valve seat 18 serves as a support surface for embedding or disposing the valve 29 within the docking station 10 after the docking station 10 is embedded in the circulatory system. The securing portion 414 helps to secure the docking station 10 and the valve 29 at the embedding position or deployment site within the circulatory system. The expandable docking station 10 and the valve 29 as described in various embodiments herein may also represent various docking stations and / or valves that may be known or developed, for example, substituting various different types of valves for the valve 29 within various docking stations and / or using them as the valve 29.

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

[0033] Referring to FIG. 4D, valve 29 expands and the valve seat 18 of the docking station supports the valve. Valve 29 may expand against the narrow valve seat 18 rather than against a wider space within the portion of the circulatory system occupied by docking station 10. Docking station 10 enables valve 29 to operate within an expansion diameter range designed therefor.

[0034] Figure 4E shows that the size and / or shape of a cross-section of the inner surface 416 of the circulatory system, such as the inner surface of a blood vessel or anatomical structure of the heart, can 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 retention portion engages the inner surface 416 despite significant variation in the shape of the blood vessel or anatomical structure of the heart along the length L of the docking station. The docking station can be made of a very elastic or compliant material that accommodates a large variation in anatomical structure. For example, the docking station can be made of a highly flexible metal, alloy, polymer, or open-cell foam. 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 elastic or compliant non-metallic materials can be used. For example, the docking station 10 can have a frame or a portion of a frame (e.g., a self-expanding frame, a retention portion, a sealing portion, a valve seat, etc.) made from these materials, such as a shape memory material like 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] An 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 a polyurethane foam (e.g., as available from Biometrix, Rockville, MD). The docking stations described herein are expandable using self-expanding and / or inflatable devices and can engage the inner surface 416 having a variable shape by the docking station.

[0036] Figure 4F shows the docking station 10 and valve 29 implanted in the pulmonary artery PA. As mentioned with respect to FIGS. 2A-2E and FIGS. 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 varying shape of the pulmonary artery PA in the same form as described with respect to FIG. 4E.

[0037] Referring to FIGS. 5A-5F, in an exemplary embodiment, the expandable docking station 10 is made of an expandable foam material such as an open-cell biocompatible foam. The 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 the 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 securing portion 414 is omitted, but the securing portion can be used. In one embodiment, the foam material can be used with an expandable frame (such as a metal, shape memory material, etc.). The foam material can cover or extend along the entire length of the frame or only a portion of the length of the frame.

[0038] FIGS. 5A-5D schematically show the deployment of the foam docking station 10 and valve 29 within the circulatory system. Referring to FIG. 5A, the docking station 10 is in a compressed form and is introduced into the deployment site of the circulatory system. For example, the docking station 10 can be positioned at the deployment site within the pulmonary artery by a catheter (such as the catheter 3600 shown in FIGS. 50A-50D). Referring to FIG. 5B, the docking station 10 expands within the circulatory system such that the sealing portion 410 engages the inner surface 416 of the circulatory system. Referring to FIG. 5C, after the docking station 10 is deployed, the valve 29 is in a compressed form and is introduced into the valve seat 18 or the inner surface 512 of the docking station 10. Referring to FIG. 5D, the valve 29 expands within the docking station such that the valve 29 engages the valve seat 18 or the inner surface 512 (for example, when the inner surface 512 acts as the valve seat).

[0039] FIG. 5E shows that the cross-section of the inner surface 416 of the circulatory system, such as the inner surface of a blood vessel or anatomical structure of the heart, can vary along its length. In an exemplary embodiment, the foam 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.

[0040] FIG. 5F shows the foam docking station 10 and valve 29 implanted in the pulmonary artery PA. As mentioned with respect to FIGS. 2A-2E and FIGS. 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 varying shape of the pulmonary artery PA in the same or a similar manner as described with respect to FIG. 4E.

[0041] Referring to FIG. 6A, a docking station, such as the docking station described with respect to FIGS. 4A-4D, is deployed within the pulmonary artery PA of the heart H. FIG. 6B shows a valve 29 deployed within 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 valve 29 within the pulmonary artery PA of FIG. 6B. When the heart is in systole, the valve 29 opens. 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 space 608 filled with blood, representing that the valve 29 is open when the heart is in systole. For simplicity of the drawing, FIG. 7B does not show the interface between the docking station 10 and the pulmonary artery. The hatching in FIG. 7B indicates the blood flow through the open valve. In an exemplary embodiment, the sealing portion 410 prevents blood from flowing between the pulmonary artery PA and the docking station 10, and by seating the valve 29 in the valve seat 18 of the docking station 10, blood is prevented from flowing between the docking station 10 and the valve 29. In this example, blood either substantially only flows or can only flow through the valve 29 when the heart is in systole.

[0042] FIG. 8 shows the valve 29, the docking station 10, and the heart H shown by FIG. 6B when the heart is in diastole. Referring to FIGS. 9A and 9B, when the heart is in diastole, the valve 29 closes. FIG. 9A is an enlarged representation of the docking station 10 and valve 29 within the pulmonary artery of FIG. 8. The blood flow within the pulmonary artery PA above the valve 29 (i.e., within the pulmonary artery branch 760) is inhibited by closing the valve 29, inhibiting the blood flow as indicated by arrow 900. The solid region 912 in FIG. 9B represents that the valve 29 is closed when the heart is in diastole.

[0043] In an 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 inner surface 416 of the circulatory system. In one embodiment, the docking station 10 includes a valve seat 18 (which is not expanded radially outward or is not substantially expanded radially outward by the radially outward force of the THV or valve 29, i.e., the diameter of the valve seat does not increase or does not increase by more than 4 mm due to the force of the THV), and a fixing / securing portion 414 and a sealing portion 410 that apply only relatively small radially outward forces 720, 722 to the inner surface 416 of the circulatory system (compared to the radially outward force applied to the valve seat 18 by the valve 29).

[0044] When the docking station is not used, the stent and frame of the THV are held in place within the circulatory system by the relatively high radially outward force 710 of the stent or frame 712 of the THV that acts directly on the inner surface 416 of the circulatory system. As in the example shown by FIG. 7A, when the docking station is used, the stent or frame 712 of the valve 29 expands radially outward or is expanded radially outward to apply a large force 710 to 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, since the valve seat 18 is not expanded or is not substantially expanded by the force 710, the force 710 is not used to fix the docking station within the circulatory system but is isolated from 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 applied by the valve 29 against the valve seat 18. For example, the radially outward sealing force 722 can be less than 1 / 2 of the radially outward force 710 applied by the valve, less than 1 / 3 of the radially outward force 710 applied by the valve, less than 1 / 4 of the radially outward force 710 applied by the valve, less than 1 / 8 of the radially outward force 710 applied by the valve, or even less than 1 / 10. 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 by itself is insufficient to hold the positions of the valve 29 and the docking station 10 within the circulation system.

[0046] In an exemplary embodiment, the radially outward force 720 of the securing / holding portion 414 against the inner surface 416 is substantially less than the radially outward force 710 applied by the valve 29 against the valve seat 18. For example, the radially outward sealing force 720 can be less than 1 / 2 of the radially outward force 710 applied by the valve, less than 1 / 3 of the radially outward force 710 applied by the valve, less than 1 / 4 of the radially outward force 710 applied by the valve, less than 1 / 8 of the radially outward force 710 applied by the valve, or even less than 1 / 10.

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

[0048] Referring to FIG. 9A, when the heart is in diastole, the valve 29 is closed and blood flow is inhibited as indicated by arrow 900. Since the valve 29 is closed and the valve 29 and the docking station 10 inhibit blood flow, the pressure P exerted on the docking station 10 and the valve 29 by the blood, as indicated by the large arrow P in FIG. 9A, is high. This high pressure P presses the lower retaining portion 414 against the surface 416 in the direction generally indicated by the large arrow F. The force F assisted by this blood flow applied to the surface 416 by the retaining portion 414 prevents the docking station 10 and the valve 29 from moving in the direction indicated by arrow 900.

[0049] The forces applied by the upper and lower retention portions 414 are determined by the amount of pressure applied by the blood to the valve 29 and the docking station 10, so the forces applied to the surface 416 are automatically proportional. That is, the force with which the upper retention portion presses against the surface 416 during the systolic phase of the heart is weaker than the force with which the lower retention portion presses against the surface 416 during the diastolic phase of the heart. This is because the pressure on the open valve 29 and docking station 10 during systole is lower than the pressure on the closed valve and docking station during diastole.

[0050] The valve seat 18 and the sealing portion 410 can be in a wide variety of different forms. For example, the valve seat 18 can be any structure that is not expanded radially outward or is not substantially expanded 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 by less than 4 mm. For example, when the valve is deployed on the valve seat, the diameter may expand by only 1 - 4 mm). For example, the valve seat 18 can include a suture or a metal ring that resists expansion or limits expansion. However, in one embodiment, the valve seat 18 (or any valve seat described herein) can be expandable over a wider range. For example, when the valve is deployed on the valve seat, the diameter may expand by 5 mm - 30 mm. In one embodiment, the diameter can expand from a diameter of 5 mm or 6 mm to a diameter of 20 mm - 29 mm, 24 mm, 26 mm, 29 mm, etc., or from different diameters within that range to different diameters. Even when further expandable, the valve seat can remain restricted in expansion. For example, it is restricted to avoid the valve seat expanding beyond the expanded diameter of the valve disposed on the valve seat or to avoid expanding beyond a diameter that firmly holds the valve within the valve seat by the force 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 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 in length than the valve 29 when the valve seat 18 is defined by a suture or a metal ring. The valve seat 18 formed by the suture or the 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 the surface 416 of the circulation system. For example, the sealing portion 410 can include fabrics, foams, biocompatible tissues, expandable metal frames, 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 attached to the body of the docking station. The docking station 10 can include a single sealing portion 410, or two or more sealing portions.

[0052] As described above, in an 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 of a very compressible or compliant material. Referring to FIG. 7C, in an exemplary embodiment, the body of the docking station 10 is made of an elastic or superelastic metal. One such metal is nitinol. If the body of the docking station 10 is made of a lattice of metal compressors, the body can have spring-like characteristics. Referring to FIG. 7C, like a spring, when the body of the docking station is unconstrained and can 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 radially outward force of the docking station body and the expanded diameter of the docking station is non-linear, but in an exemplary embodiment, the relationship can also be linear. In the example shown by FIG. 7C, the curve 750 shows the relationship between the radially outward force exerted by the docking station 10 and the compressed diameter of the docking station. In region 752, the curve 750 has a small slope. In this region 752, the radially outward force is small and changes only slightly. In an exemplary embodiment, region 752 corresponds to a diameter of 25 mm to 40 mm, such as 27 mm to 38 mm. The radially outward force is small but not zero in region 752. In region 754, the curve 750 has a larger slope. In this region 754, as the docking station is compressed, the radially outward force increases significantly. In an exemplary embodiment, the body of the stent is constructed to be in the region 752 of small slope. This allows the sealing portion 710 to apply only a small radially outward force to the inner surface 416 of the circulatory system over a wide range of diameters.

[0053] The securing portion 414 can be in a variety of different forms. For example, the securing portion 414 can be any structure that sets the position of the docking station 10 within the circulatory system. For example, the securing portion 414 can be in contact with or pressed against the inner surface 416 or extend around the anatomical structure of the circulatory system to set the position of the docking station 10. The securing portion 414 can be part of or define a part of the body of the docking station 10, or the securing portion 414 can be a separate component attached to the body of the docking station. The docking station 10 can include a single securing portion 414, or two or more securing portions.

[0054] Figures 10A - 10C show that the docking station 10 can have any combination of one or more different types of valve seats 18 and sealing portions 410. In the example shown by Figure 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 Figure 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 Figure 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 Figure 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 described above, the lengths of the pulmonary artery PA and other anatomical structures of the circulatory system can vary significantly from patient to patient. Referring to FIGS. 11A-11D, in an exemplary embodiment, as indicated by arrow 1100, the length of the docking station 10 is adjustable. This adjustability 1100 refers to the ability to adjust the length of the docking station after implantation / expansion, rather than the length change that inherently occurs when the stent expands from a compressed state to an expanded state. The length can be adjusted in a wide 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" with respect to a two-part docking station is synonymous with "part," and it is not required that the sizes of the first and second halves or the first and second parts be equal, 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 "fitted" into the first half 1102. The length of the docking station 10 is set by the amount of insertion or "fitting." Any of the docking stations 10 illustrated and described in this patent application can be made length adjustable by creating the docking station from two parts that are nested within each other or adjustable relative to each other in another way. In one embodiment, the length of a single-piece docking station can be foldable and expandable. In one embodiment, the docking station can be formed of a material whose shape can be changed 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 an 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 into the pulmonary artery. For example, the first half 1102 can be positioned and expanded as desired such that, for example, the distal end 1106 of the first half is aligned with or extends 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 securing portion 414 contact the pulmonary artery and set the position of the docking station 10 within the pulmonary artery. After being 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, latches, sutures, intersections, links, and / or other attachment devices / mechanisms can be used to assist in securing the halves / portions together.

[0057] In the example shown by FIGS. 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. FIGS. 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 FIG. 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 FIG. 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. In the example shown by FIG. 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 attached to the body of the docking station half 1104.

[0058] Figures 12A - 12D illustrate exemplary embodiments 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 seats 18 and sealing portions 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 formed integrally 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 formed integrally with the body of the docking station 10, and the sealing portion is formed integrally with the body of the docking station. In the example shown by FIG. 12D, the valve seat 18 is formed integrally 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] Figures 13A through 13D illustrate that the docking station shown by Figures 12A through 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 seats 18 and sealing portions 410 on either or both of the two pieces. In the example shown by Figure 13A, the first half-piece 1102 includes an integral sealing portion 410. The second half-piece 1104 includes a valve seat 18 that is a separate component attached to the body of the docking station 10, and the sealing portion 410 is formed integrally with the body of the docking station. In the example shown by Figure 13B, the first half-piece 1102 includes a sealing portion 410 that is separate from the body of the first half-piece 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 Figure 13C, the first half-piece 1102 includes an integral sealing portion 410. The valve seat 18 is formed integrally with the body of the second half-piece 1104 of the docking station 10, and the sealing portion 410 is formed integrally with the body of the second half-piece 1104. In the example shown by Figure 13D, the first half-piece 1102 includes a sealing portion 410 that is separate from the body of the first half-piece 102. The valve seat 18 is formed integrally with the body of the second half-piece 1104 of the docking station 10, and the sealing portion 410 is a separate component attached to the body of the second half-piece 1104.

[0060] Referring to FIGS. 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 at least from the sealing portion 410 to the valve seat 18 to prevent blood from flowing around the valve 29. In an exemplary embodiment, since blood can flow freely through the permeable portion 1400, the portion of the docking station that does not seal the inner surface 416 of the circulatory system or seal the valve 29 does not impede blood flow. For example, the docking station 10 can extend into a branch of the pulmonary artery, and blood can flow freely through the docking station 10 by the portion 1400 of the docking station 10 that extends into the pulmonary artery. In an exemplary embodiment, since blood can flow freely through the permeable portion 1400, when the heart beats, the region 1420 between the docking station and the circulatory system is flushed with blood, thereby preventing blood from stagnating in the region 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 coated 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 cloth such as a PET cloth or a cloth treated with a blood-impermeable coating, a biocompatible coating material, a polyester, or a processed biological material such as a pericardium.

[0062] Figures 14A - 14G show that a 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 Figures 14B, 14D, and 14F, or can be separate as shown by Figures 14C, 14E, and 14G. In Figures 14F and 14G, the docking station 10 includes a portion 1410. These portions 1410 are similar to the sealing portion 410, but since the portion 1410 is part of the permeable portion 1400, a seal with the inner surface 416 of the circulation system is not formed. The valve seat 18 can be formed separately from the body of the docking station as shown by Figures 14A - 14C, or can be integrally formed with the body of the docking station 10 as shown by Figures 14D - 14G.

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

[0064] Figures 15A, 15B, 17A, and 17B show the frame 1500 in an unrestrained expanded state. In this exemplary embodiment, the retention portion 414 includes the ends or vertices 1510 of the metal compression member 1502 at the proximal end 12 and the distal end 14. The sealing portion 410 is between the retention portion 414 and the waist 16. In the unconstrained state, the retention portion 414 extends generally radially outwardly and is radially outside 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 of a very elastic or compliant material that accommodates a wide variation in anatomical structure. For example, the docking station can be made of a highly flexible metal, alloy, polymer, or open cell foam. An example of a highly elastic metal is nitinol, although other metals and highly elastic or compliant non-metallic materials can be used. The docking station 10 can be self-expanding, manually expandable (e.g., expandable by a balloon), or mechanically expandable. The self-expanding docking station 10 can be made of a shape memory material such as nitinol, for example.

[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 an exemplary embodiment, the band 20 extends around the waist or narrow portion 16 or is integral with the waist 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 becomes relatively non-expandable in its post-deployment configuration. In the example shown by FIG. 19, the valve 29 forms the valve seat 18 of the docking station 10 by being fixed as its foldable frame expands into the narrow portion 16. As described above, the non-expandable or substantially non-expandable valve seat 18 prevents the radially outward force of the valve 29 from migrating 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 expand slightly elastically when the valve is deployed thereagainst. This optional elastic expansion of the waist / valve seat 18 can help apply pressure to the valve 29 to hold the valve 29 in a predetermined position within the docking station.

[0066] The band can be in a wide variety of different forms and can be made from a wide variety of different materials. Band 20 can be made of PET, one or more suture threads, fabric, metal, polymer, biocompatible tape, or other relatively inextensible materials known in the art that are sufficient to maintain the shape of valve seat 18 and hold valve 29 in place. The band can extend around the outside of the stent or can be an integral part thereof, such as when fabric or another material is woven within or through the cells of the stent. Band 20 can be narrow, such as the suture band of FIG. 18, or can be wide. The band can be of various widths, lengths, and thicknesses. In one non-limiting example, valve seat 18 is 27-28 mm wide, but the diameter of the valve seat should be within the operating range of a particular valve 29 that is fixed within valve seat 18 and may be different from the above example. Valve 29 can optionally expand slightly around either side of the valve seat when placed within the docking station. This configuration, which may be referred to as a "dog bone" (e.g., due to the shape formed around the valve seat or band), can help hold the valve in place.

[0067] FIGS. 20 and 21 show docking station 10 of FIG. 18 implanted in a circulatory system such as the pulmonary artery. Sealing portion 410 provides a seal between docking station 10 and the inner surface 416 of the circulatory system. In the examples of FIGS. 20 and 21, sealing portion 410 is formed by providing an impermeable material 21 (see FIG. 21) on frame 1500 or a portion thereof. In particular, sealing portion 410 can include a portion 2000 that extends along the rounded radially outer side of the lower side of frame 1500. In an exemplary embodiment, impermeable material 21 extends at least from portion 2000 of frame 1500 to valve seat 18. This makes the docking station impermeable from sealing portion 410 to valve seat 18. Thus, all blood flowing from inflow end 12 towards outflow end 14 is directed towards valve seat 18 (and, if loaded or deployed within the valve seat, towards valve 29).

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

[0069] From another perspective, this embodiment of the docking station is designed to seal in the proximal inflow section 2000 to create a conduit for blood flow. However, the distal outflow section remains substantially open, thereby allowing the docking station 10 to be positioned at a high location within the pulmonary artery without restricting blood flow. For example, the permeable portion 1400 can extend into a branch of the pulmonary artery and does not obstruct or significantly obstruct blood from flowing across 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 or at least a portion of the distal outflow section 14. As one non-limiting example, when the docking station 10 is placed within the pulmonary artery, which is a major blood vessel, a significant amount of blood flowing through the artery is sent to the valve 29 by the impermeable material 21. Since the fabric 21 is fluid-impermeable, blood cannot pass through. Also, various other biocompatible covering materials can be used, such as a foam or fabric treated with a blood-impermeable coating, polyester, or a processed biological material such as pericardium.

[0070] In the example shown by FIG. 21, more docking station frames 1500 include the 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 ends at a row of cells 1504 in front of the outflow end. Therefore, the row of the most distal cells 1504 forms the permeable portion 1400. However, more rows of cells 1504 can be uncoated with the impermeable material to form a larger permeable portion. The permeable portion 1400 allows blood to enter and exit the region 2130 as indicated by the arrow 2132. That is, in an exemplary embodiment, blood can enter and exit the region 2100.

[0071] The valve seat 18 can serve as a support surface for embedding or disposing the valve 29 within the docking station 10. The securing portion 414 can secure the docking station 10 at an embedding position or a deployment site within the circulatory system. The illustrated securing portion has an outwardly curved flare that helps to fix the docking station 10 within an artery. As used herein, "outward" 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 securing portion 414 engages the surface 416 at an angle α (from the normal of the surface of the securing portion 414 to the tangent of the central point on the surface), and that angle can be, for example, about 45 degrees, such as 30 - 60 degrees, rather than extending substantially radially outward as in the uncompressed state (see FIG. 15B) (i.e., α is 0 - 20 degrees or about 10 degrees). This inward bend of the securing portion 414, as indicated by arrow 2020, acts to secure the docking station 10 within the circulatory system. The securing portion 414 is at the wider inflow end portion 12 and outflow end portion 14 and compresses the inner surface 416. The flared securing 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 flared securing portion 414 is pushed into the surrounding tissue by the force and resists the movement of the stent, as will be described in more detail later. In certain embodiments, the docking station generally has an hourglass shape with a wide distal and proximal end portion having a flared securing portion and a narrow band-shaped waist portion therebetween where the valve is expanded therein.

[0072] Figure 22 shows a docking station 10 deployed within a circulatory system and a 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 expands within the docking station such that the valve 29 engages the valve seat 18. In the example shown by Figure 22, the docking station 10 is longer than the valve. However, in one embodiment, the docking station 10 may be the same length as or shorter than the valve 29.

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

[0074] Figures 23A and 23B show that the docking station 10 can be used to fit various different sizes of the anatomical structure of the circulatory system in order to embed a valve 29 having a certain size. In the examples of Figures 23A and 23B, the same-sized docking station 10 is deployed within two different-sized vessels 2300, 2302, such as pulmonary arteries PA of two different sizes. In that example, the vessel 2300 shown by Figure 23A has an effective diameter larger than that of the vessel 2302 shown by Figure 23B. (It should be noted that in this patent application, the size of the anatomical structure of the circulatory system is referred to by the terms "diameter" or "effective diameter". The anatomical structure of the circulatory system is often not circular. The terms "diameter" and "effective diameter" refer herein to the diameter of a circle or a disc that can be deformed to fit within a non-circular anatomical structure.) In the examples shown by Figures 23A and 23B, the sealing portion 410 and the securing portion 414 are adapted to contact each of the vessels 2300, 2302. However, the valve seat 18 remains the same size even when the sealing portion 410 and the securing portion 414 are compressed. Thus, the docking station 10 adapts a wide variety of different anatomical structure sizes to embed a standard or single-sized valve. For example, the docking station can adapt to vessel diameters of 25 mm to 40 mm, such as 27 mm to 38 mm, and provide a valve seat with 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 use in providing a valve seat with a diameter larger or smaller than 25 mm to 40 mm for the vessel diameter and larger or smaller than 24 mm to 30 mm.

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

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

[0077] In the example shown in FIGS. 24 and 25, the stent or frame 712 of the valve 29 expands radially outward or is expanded radially outward to apply a large force 710 to 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, since the valve seat 18 is not expanded or is substantially not expanded by the force 710, the force 710 is not used to secure the docking station within the circulatory system but is isolated from the circulatory system.

[0078] In an exemplary embodiment, the radially outward force 722 of the sealing portion 410 on both the larger vessel 2300 and the smaller vessel is substantially less than the radially outward force 710 applied by the valve 29 to the valve seat 18. For example, in the case of the smallest vessel adapted by the docking station 10 to embed the valve, the radially outward sealing force 722 can be less than 1 / 2 of the radially outward force 710 applied by the valve, less than 1 / 3 of the radially outward force 710 applied by the valve, less than 1 / 4 of the radially outward force 710 applied by the valve, less than 1 / 8 of the radially outward force 710 applied by the valve, or even less than 1 / 10. 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 by itself is insufficient to secure the positions of the valve 29 and the docking station 10 within the circulatory system. In one embodiment, the radially outward force 722 is sufficient to secure the positions of the valve 29 and the docking station 10 within the circulatory system.

[0079] In an exemplary embodiment, the docking station 10 shown in FIG. 18 also includes a fixing / securing portion 414 that applies a radially outward force 720 that is substantially less than the radially outward force 710 applied by the valve 29 to the valve seat 18. For example, in the case of the smallest vessel adapted by the docking station 10 to embed the valve, the radially outward sealing force 720 can be less than 1 / 2 of the radially outward force 710 applied by the valve, less than 1 / 3 of the radially outward force 710 applied by the valve, less than 1 / 4 of the radially outward force 710 applied by the valve, less than 1 / 8 of the radially outward force 710 applied by the valve, or even less than 1 / 10. In one embodiment, the radially outward force 720 of the fixing / securing portion 414 is insufficient by itself to secure the positions of the valve 29 and the docking station 10 within the circulatory system. In one embodiment, the radially outward force 720 is sufficient to secure the positions of the valve 29 and the docking station 10 within the circulatory system.

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

[0081] Figures 26A - 26C show the docking station 10 of FIG. 18 implanted in the pulmonary artery. FIG. 26A shows the contour of the docking station 10 implanted in the pulmonary artery PA. FIG. 26B shows the contour of the docking station 10 implanted in the pulmonary artery PA with the valve 29 schematically shown as being loaded or deployed within the docking station 10. FIG. 26C shows the docking station 10 and the valve 29 as shown in FIG. 22 implanted in the pulmonary artery PA. As mentioned with respect to FIGS. 2A - 2E and FIGS. 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 varying shape of the pulmonary artery PA. The docking station 10 is shown as being positioned below a branch or bifurcation of the pulmonary artery. However, the docking station 10 is often positioned such that the end 14 extends into the pulmonary artery bifurcation 210. When it is contemplated that the docking station 10 extends into the pulmonary artery bifurcation, the docking station 10 can have a blood - permeable portion 1400 (such as that shown in FIG. 21).

[0082] Figure 27 shows 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 shows only one of many possible configurations. In the example shown by FIG. 27, the docking station 10 has a relatively wide proximal inflow end 12 and a distal outflow end 14, and an elongated and relatively narrow portion 2716. The valve seat 18 and the sealing portion 410 can be provided at any location along the length of the elongated and relatively narrow portion 2716. In the example shown by FIG. 27, the frame 2700 of the docking station 10 is preferably a stent composed of a plurality of metal compression members 1502 that form cells 1504. The frame 2700 or a portion of the frame can optionally be coated with an impermeable material 21 (such as that shown in FIG. 18).

[0083] FIG. 27 shows the frame 2700 and the sealing portion 410 in an unconstrained expanded state / configuration or a post-deployment configuration. In this exemplary embodiment, the retention portion 414 comprises the ends or vertices 1510 of the metal compression member 1502 at the proximal end 12 and the distal end 14. The sealing portion 410 can be a separate component disposed around the frame 2700 between the retention portions 414. In the unconstrained state, the retention portions 414 extend substantially radially outwardly and can be radially outside the sealing portion 410.

[0084] The docking station 10 shown by FIG. 27 can be made of a very elastic or compliant material that accommodates a wide variation in anatomical structures. For example, the docking station can be made of a highly flexible metal (e.g., the frame of the example of FIG. 27), as well as cloth and / or a continuous foam (e.g., the sealing portion of the example of FIG. 27). An example of a highly elastic metal is nitinol, but other metals and very elastic or compliant non-metallic materials can be used. An example of a continuous foam that can be used is a biocompatible foam such as a polyurethane foam (such as available from Biometrix, Rockville, MD). In one embodiment, the foam forming the sealing portion can also form a valve seat on its inner surface.

[0085] Continuing to refer to FIG. 27, the frame 2700 and / or a separate sealing portion 410 can include any band 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 region of the valve seat 18 without using a band 20. Any band 20 reinforces the frame 2700 and / or the sealing portion and makes the valve seat relatively non-expandable.

[0086] Any band 20 can be in a wide variety of different forms, 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 suture threads, fabric, metal, polymer, biocompatible tape, or other relatively inextensible materials known in the art that are sufficient to maintain the shape of the valve seat 18 and hold the valve 29 in place. The band can extend around the outside of the stent, or can be an integral part thereof, such as when fabric or another material is woven within or through the cells of the stent. Band 20 can be narrow, such as the suture band of FIG. 18, or can be wide, as shown by the dashed line in FIG. 27. In one non-limiting example, the 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 fixed within the valve seat 18 and can be different from the above example.

[0087] Figures 28 and 29 show a modification of the docking station 10 shown in FIG. 27, which is of variable length. As described above, the lengths 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, as indicated by arrow 1100, the length of the docking station 10 is adjustable. The length can be adjusted in a wide variety of different ways and can be adjustable, for example, by any of the methods described elsewhere in this disclosure. In the example shown by FIGS. 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 "fitted" into the first half 1102. The length of the docking station 10 is set by the amount of insertion or "fitting".

[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 into 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 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 securing portion 414 contact the pulmonary artery and set the position of the docking station 10 within the pulmonary artery. After being 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, a lock, locking mechanism, suture, intersection, link, and / or other attachment device / mechanism can be (additionally or alternatively) used to secure the two halves together.

[0089] In the example shown by FIGS. 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 can be included on the second half 1104 or at different positions on the first half and / or the second half.

[0090] Figures 30 and 31A show the docking station 10 of FIGS. 27 of FIGS. 28 and 29 embedded 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 examples of FIGS. 30 and 31A, the sealing portion 410 is an expandable material such as an expandable continuous 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, the impermeable material 21 can be provided over a portion of the frame (e.g., from the sealing portion 410 to the valve seat 18 to make the docking station from the sealing portion 410 to the valve seat 18 impermeable). Whether or not the sealing portion 410 overlaps the valve seat 18, or whether or not the impermeable material is provided from the sealing portion 410 to the valve seat 18, all blood flowing in the direction from the inflow end 12 to the outflow end 14 is directed to the valve seat 18 (and to the valve 29 if loaded or disposed within the valve seat).

[0091] In an exemplary embodiment of the docking station 10, at least the outflow portion 14 of the frame 2700 is relatively open. Referring to FIG. 31A, this allows the docking station 10 to be positioned at a high position within the pulmonary artery without restricting blood flow. For example, the open cell 1504 can extend into a branch or bifurcation of the pulmonary artery, but does not obstruct or significantly obstruct blood flow across the branch. The open cell 1504 allows blood to flow through the frame 1500, as indicated by the arrow 3132 in FIG. 31A.

[0092] In the example shown by FIGS. 30 and 31A, the docking station 10 is retained within the pulmonary artery PA by expanding one or more of the retention portions 414 radially outward into regions 210, 212 of the pulmonary artery PA where the inner surface 416 also extends outward. For example, the retention portion 414 can be configured to extend radially outward into the pulmonary artery bifurcation 210 and / or the opening 212 of the pulmonary artery into 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, and the first portion 1102 is arranged such that the retention portion 414 extends radially outward into the pulmonary artery bifurcation 210. Next, the second portion 1104 can be positioned within the first portion 1102 such that the retention portion 414 coincides with the opening of the pulmonary artery or another region extending outward of the pulmonary artery. Once in place, the second portion 1104 can be expanded to fix the second section 1104 relative to the first section 1102 and fix the second section to the pulmonary artery at the opening 212 or other region extending outward.

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

[0094] Referring to FIG. 32A, the docking station shown by FIG. 18 is deployed within the pulmonary artery PA of the heart H. FIG. 32B shows the comprehensively shown valve 29 deployed within the docking station 10 shown by FIG. 32A. In FIGS. 32A and 32B, the heart is in the systolic phase. FIG. 33A is an enlarged representation of the docking station 10 and the valve 29 within the pulmonary artery PA of FIG. 32B. When the heart is in the systolic phase, the valve 29 opens. 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 representing that the valve 29 is open when the heart is in the systolic phase. For simplicity of the drawing, FIG. 33B does not show the interface between the docking station 10 and the pulmonary artery. The hatching in FIG. 33B indicates the blood flow through the open valve. In an exemplary embodiment, the sealing portion 410 prevents blood from flowing between the pulmonary artery PA and the docking station 10, and by seating the valve 29 in the valve seat 18 of the docking station 10, blood is prevented from flowing between the docking station 10 and the valve 29. In this example, blood substantially only flows through or can flow through the valve 29 when the heart is in the systolic phase.

[0095] FIG. 34 shows the valve 29 shown by FIG. 32B, the docking station 10, and the heart H when the heart is in the diastolic phase. Referring to FIG. 34, when the heart is in the diastolic phase, the valve 29 closes. FIG. 35A is an enlarged representation of the docking station 10 and the valve 29 within the pulmonary artery of FIG. 34. The blood flow within the pulmonary artery PA above the valve 29 (i.e., within the pulmonary artery branch 210) is inhibited by closing the valve 29, inhibiting the blood flow as indicated by arrow 3400. The solid region 3512 in FIG. 35B represents that the valve 29 is closed when the heart is in the diastolic phase.

[0096] Referring to FIG. 33A, the radially outward force 720 of the fixation / holding portion 414 against the inner surface 416 is substantially less than the radially outward force 710 applied by the valve 29 against the valve seat 18. For example, the radially outward sealing force 720 can be less than 1 / 2 of the radially outward force 710 applied by the valve, less than 1 / 3 of the radially outward force 710 applied by the valve, less than 1 / 4 of the radially outward force 710 applied by the valve, less than 1 / 8 of the radially outward force 710 applied by the valve, or even less than 1 / 10 of the radially outward force 710 applied by the valve.

[0097] Referring to FIGS. 33A and 35A, in an exemplary embodiment, the radially outward force 720 of the holding portion 414 is by itself insufficient to hold the positions of the valve 29 and the docking station 10 within the circulatory system. Rather, the pressure of the blood within the space 3208 is used to enhance the holding of the holding 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 indicated by the arrow 3202. Since the valve 29 is open and blood is flowing through the valve 29, the pressure P applied by the blood against the docking station 10 and the valve 29, as indicated by the small arrow P shown in FIG. 33A, is low. Although the pressure P is low, the docking station and its upper holding portion 414 are pressed against the surface 416 in a direction generally indicated by the arrow F (the small F represents a relatively small force). The force F assisted by this blood flow applied by the holding portion 414 against the surface 416 prevents the docking station 10 and the valve 29 from moving in the direction of the 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 indicated by arrow 3400. Since valve 29 is closed and valve 29 and docking station 10 inhibit blood flow, the pressure P exerted on docking station 10 and valve 29 by the blood is high, as indicated by the large arrow P in FIG. 35A. This high pressure P presses the lower retaining portion 414 against surface 416 in the direction indicated by the large arrow F (large F represents a relatively large force). The force F assisted by this blood flow exerted on surface 416 by the retaining portion 414 prevents docking station 10 and valve 29 from moving in the direction indicated by arrow 3400.

[0099] Referring to FIGS. 33A and 35A, since the forces exerted by the upper and lower retaining portions 414 are determined by the amount of pressure exerted on valve 29 and docking station 10 by the blood, the forces exerted on surface 416 are automatically proportional. That is, the force with which the upper retaining portion presses against surface 416 when the heart is in systole is weaker than the force with which the lower retaining portion presses 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 lower 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 malfunction / regurgitation / others of a heart valve) can include various steps, such as steps associated with introducing and deploying a docking station to a desired position / treatment area, and introducing and deploying a valve within the docking station. For example, FIG. 36A shows a docking station shown by FIG. 18, which is deployed by a catheter 3600. The docking station 10 can be positioned and deployed in a wide variety of different ways. Access can be obtained through the femoral vein, or the access can be percutaneous. Generally, any vascular pathway leading to the pulmonary artery can be used. In an exemplary embodiment, a guidewire and a subsequent catheter 3600 are advanced to the pulmonary artery PA using the femoral vein, inferior vena cava, tricuspid valve, and right ventricle RV. The docking station 10 can be placed within the outflow tract of the right ventricle / 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 within the pulmonary artery (PA) of the heart H. FIG. 36C shows the valve 29 deployed within the docking station 10 shown by FIG. 32A. In the examples shown by FIGS. 36C, 37A, 38, 39A, and 39B, the valve 29 is depicted as a SAPIEN 3 THV provided by Edwards Lifesciences, although various other valves can also be used. In FIGS. 36A - 36C, the heart is in systole. FIG. 37A is an enlarged representation of the docking station 10 and the valve 29 within the pulmonary artery of FIG. 36C. When the heart is in systole, the valve (e.g., 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 arrow 3202. FIG. 37B shows the space 3208 representing that the valve is open when the heart is in systole. For simplicity of the drawing, FIG. 37B does not show the interface between the docking station 10 and the pulmonary artery. The hatching in FIG. 37B indicates the blood flow through the valve. In an exemplary embodiment, the sealing portion 410 prevents blood from flowing between the pulmonary artery PA and the docking station 10, and by seating the valve in the valve seat 18 of the docking station 10, it prevents blood from flowing between the docking station 10 and the valve. In this example, blood substantially only flows through or can only flow through the valve when the heart is in systole.

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

[0103] Referring to FIG. 39A, the radially outward force 720 of the fixation / retention portion 414 against the inner surface 416 is substantially less than the radially outward force 710 applied by the valve (e.g., Sapien 3 valve) against the valve seat 18. For example, the radially outward sealing force 720 can be less than 1 / 2 of the radially outward force 710 applied by the valve, less than 1 / 3 of the radially outward force 710 applied by the valve, less than 1 / 4 of the radially outward force 710 applied by the valve, less than 1 / 8 of the radially outward force 710 applied by the valve, or even less than 1 / 10. A 29 mm sized Sapien 3 valve generally applies a radially outward force 710 of about 42 Newtons. In one embodiment, the radially outward force of the deployed docking station described herein, or of one or more portions of the deployed docking station, can be about 4 - 16 Newtons, although other forces are possible.

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

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

[0106] Referring to FIG. 43A, the docking station 10 is retained within the pulmonary artery PA by expanding one or more of the retention / fixation portions 414 radially outward into regions 210, 212 of the pulmonary artery PA whose inner surface 416 also extends outward. For example, the retention portion 414 can be configured to extend radially outward into the pulmonary artery branch 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 and / or a docking station with multiple components. For example, the docking station 10 can be a nested docking station as shown by FIG. 28, where the first portion 1102 can be arranged such that the retention portion 414 extends radially outward into the pulmonary artery branch 210, and the second portion 1104 can be positioned within the first portion 1102 such that its retention portion 414 aligns with the opening 212 of the pulmonary artery. The extension of the retention portion 414 into regions 210, 212 sets the position of the docking station 10 within the pulmonary artery PA and helps prevent the pressure P shown in FIG. 43A from moving the docking station.

[0107] The valve 29 used with the docking station 10 can be in a wide variety of different forms. In an exemplary embodiment, the valve 29 can be configured to be implanted into the heart H via a catheter. For example, the valve 29 can be made 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 placed using transcatheter application / placement or surgical application / placement.

[0108] Figures 44 to 48 show some examples of many valves or valve configurations that can be used. Any valve type can be used, and some valves conventionally applied surgically can be modified for transcatheter implantation. Figure 44 shows an expandable valve 29 for transcatheter implantation, as illustrated and described in U.S. Patent No. 8,002,825, which is incorporated herein by reference in its entirety. An example of a tricuspid valve is illustrated and described in International Application Publication No. WO2000 / 42950, which is incorporated herein by reference in its entirety. Another example of a tricuspid valve is illustrated and described in U.S. Patent No. 5,928,281, which is incorporated herein by reference in its entirety. Another example of a tricuspid valve is illustrated and described in U.S. Patent No. 6,558,418, which is incorporated herein by reference in its entirety. Figures 45 to 47 show an exemplary embodiment of an expandable tricuspid valve 29, such as the Edwards SAPIEN transcatheter heart valve. Referring to Figure 45, in an exemplary embodiment, the valve 29 includes a frame 712 that houses a tricuspid valve 4500 (see Figure 46) compressed inside the frame 712. Figure 46 shows the expanded frame 712 and the valve 29 in the open state. Figure 47 shows the expanded frame 712 and the valve 29 in the closed state. Figures 48A, 48B, and 48C show an example of an expandable valve 29, as illustrated and described in U.S. Patent No. 6,540,782, which is incorporated herein by reference in its entirety. An example of a valve is illustrated and described in U.S. Patent No. 3,365,728, which is incorporated herein by reference in its entirety. Another example of a valve is illustrated and described in U.S. Patent No. 3,824,629, which is incorporated herein by reference in its entirety. Another example of a valve is illustrated and described in U.S. Patent No. 5,814,099, which is incorporated herein by reference in its entirety. Any of these or other valves can be used as the valve 29 in the various embodiments disclosed herein.

[0109] Figures 49A, 49B, and 50A - 50D show the 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 elongate nose cone 28 connected to the docking station connector 4914 by a connecting tube 4916.

[0110] The docking station 10 can be disposed within the outer tube / sleeve 4910 (see FIG. 49B). The elongate legs 5000 can connect the docking station 10 to the docking station connector 4914 (see FIG. 49B). The elongate legs 5000 can be a retaining portion that is longer than the remaining portion of the retaining portion 414. The catheter 3600 can be sent beyond the guide wire 5002 to position the docking station 10 at the delivery site.

[0111] Referring to FIGS. 50A - 50D, the outer tube 4910 is gradually withdrawn relative to the inner tube 4912, the docking station connector 4914, and the elongate nose cone 28 to deploy the docking station 10. In FIG. 50A, the docking station 10 begins to expand from the outer tube 4910. In FIG. 50B, the distal end 14 of the docking station 10 expands from the outer tube 4910. In FIG. 50C, the docking station 10 expands outside the outer tube, but the elongate 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 while deploying the docking station within the circulatory system, and the docking station can be deployed in a similar manner.

[0112] Figures 51 and 54 illustrate exemplary embodiments of the nose cone 28. In an exemplary embodiment, the nose cone 28 is the elongated flexible tip or distal end 5110 of a catheter that is used to assist in advancing the catheter 3600 into the heart. In the illustrated example, the nose cone 28 is a long, gradually tapering cone, and the relatively flexible distal end of the cone has a narrow width. In one non-limiting embodiment, the nose cone has a length of 1.5 inches, and the lumen 5200 of the nose cone 28 has an inner diameter of 0.04 inches to accommodate the guide wire 5002. In one embodiment, as the diameter of the nose cone 100 increases from the narrow distal end to the wide proximal end, the cone gradually becomes more rigid. This may be due to an increase in thickness, and / or the nose cone can be constructed from different materials having different durometers. Optionally, to prevent a sharp change in stiffness, the stiffness at the point where the nose cone connects to the outer tube 4910 can be approximately the same as the stiffness of the outer tube 4910. In the example shown by FIGS. 51 and 54, the elongated distal ends 5110 of the nose cone 28 are the same. In one embodiment, the taper of the nose cone 28 extends over only the entire length or a portion of the length from end to end of the nose cone 28. To form the taper, the outer diameter of the nose cone 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 with respect to the longitudinal axis of the nose cone 28.

[0113] In an exemplary embodiment, the longer distal end 5110 of the nose cone 28 assists in advancing around bends or curves in the vasculature of the subject. As the length of the nose cone 28 increases, more of the tip passes around the bend, resulting in a "follow-the-leader" effect with the remaining portion of the nose cone.

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

[0115] In one non-limiting example, the shelf portion 5310 of the nose cone 28 fits snugly within the lumen or outer lumen of the catheter assembly 3600, which, in one non-limiting example, can have a diameter of about 0.2 inches or 0.1 inches to 0.4 inches. In one embodiment, the outer diameter of the largest portion of the nose cone 28 can be 0.27 inches or 0.2 inches to 0.4 inches, and the diameter at the distal tip of the nose cone can be 0.069 inches or 0.03 inches to 0.1 inches. Again, these dimensions are for illustrative purposes only. For example, the outer diameter or largest outer diameter of the nose cone 28 can be larger (e.g., slightly larger as shown) than the outer diameter of the outer tube 4910, the outer diameter of the nose cone 28 can be the same as the outer diameter of the outer tube 4910, or the outer diameter of the nose cone 28 can be 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 nose cone 28 is angled. The continuously angled proximal end 5112 prevents the delivery catheter from snagging on the docking station 10 embedded in the heart when the delivery catheter is withdrawn. Thus, the base portion 5112 enables easier removal of the delivery system. Referring to FIG. 55, the outer tube 4910 can include a mating portion 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 nose cone 28 fits snugly within the outer tube / sleeve 4910 (optionally beveled) of the catheter assembly 3600. The outer diameter or maximum outer diameter of the nose cone 28 can be larger (e.g., slightly larger) than the outer diameter of the outer tube 4910, the outer diameter of the nose cone 28 can be the same as the outer diameter of the outer tube 4910 as shown, or the outer diameter of the nose cone 28 can be smaller (e.g., slightly smaller) than the outer diameter of the outer tube 4910.

[0118] The docking station 10 can be connected to a catheter assembly, or to a docking station connector 4914 of a catheter assembly, in a variety of different forms. For example, the docking station 10 can be connected to the catheter assembly using a lock, a locking mechanism, a suture (e.g., one or more sutures that are releasably attached, tied, or woven through one or more parts of the docking station), an interlock device, combinations thereof, or other attachment mechanisms. Some of these connection or attachment mechanisms can be configured such that the docking station can be withdrawn into the catheter assembly without catching the edge of the catheter assembly by constraining the proximal end of the docking station to a smaller cross-section or a folded configuration, for example, to allow for adjustment, removal, replacement, etc. of the docking station. FIGS. 56, 57, 57A, and 57B show a non-limiting example of how the docking station 10 can be connected to the docking station connector 4914. As shown by FIGS. 50A-50D, in an exemplary embodiment, the docking station 10 self-expands when extruded from an outer tube. One strategy for controlling the expansion of the docking station 10 is to secure at least one end, such as the proximal end 12 of the stent, to the docking station connector 4914. This strategy allows the distal end 14 of the stent to be first expanded without the proximal end expanding (see FIG. 50B). Next, when the stent is moved forward relative to the outer tube 4910, the proximal end 12 disengages from the docking station connector 4914 and the proximal end 12 of the docking station can expand (see FIG. 50D).

[0119] One way to achieve this strategy 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, such as two, three, four, etc., can be included. The extensions 5000 can be in a wide variety of different forms. The extension 5000 can engage with the docking station connector 4914 within the outer tube 4910. In an exemplary embodiment, the docking station connector 4914 can engage the inner surface 5600 of the extension 5000. In an exemplary embodiment, in addition to the possible engagement between the inner surface 5600 (see FIG. 57A) of the extension 5000 and the docking station connector 4914, when the distal portion of the catheter assembly and / or the docking station is in a straight or substantially straight configuration, the extension 5000 and the docking station connector 4914 are configured to limit the retention engagement therebetween to two points, although these can similarly be configured to limit the retention engagement to a different number of points, for example, 3 to 6 points. In an exemplary embodiment, when the distal portion of the catheter assembly and / or the docking station is in a straight or substantially straight configuration, due to the radially outward biasing force of the compressed extension, the inner surface 5600 of the extension 5000 does not contact the docking station connector 4914. In this embodiment, the inner surface 5600 of the extension 5000 can contact the docking station connector 4914 due to the bend of the catheter assembly 3600 and / or the docking station. The extension 5000 can include a head 5636 having a side surface 5640 that extends away from the straight portion 5638 at an angle β, such as 30 to 60 degrees (see FIG. 57A). Such a head 5636 can be substantially triangular as shown, or the side surfaces 5640 that extend at an angle 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 shape as the illustrated triangular head without being triangular.

[0120] The delivery catheter 3600 bends and curves consistently as it moves through the vasculature of the subject. The head 5636 that transitions directly from the straight portion 5638 of the extension 5000 to a T-shape, a curved T-shape, a circle, or a sphere generally comes to have a retention contact with the docking station connector 4914 at more than two points (excluding the possible engagement between the inner surface 5600 of the extension 5000 (see FIG. 17A) and the docking station connector 4914). Referring to FIGS. 57A and 57B, the head 5636 having side surfaces 5640 that extend away from each other at an angle β, such as a triangular head, results in a head 5636 that touches the docking station connector 4914 only at 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 the docking station 10 move through the body during delivery. In an exemplary embodiment, this tilt may also result in contact only at two points between the extension 5000 and the docking station connector 4914 (excluding the possible engagement between the inner surface 5600 of the extension 5000 (see FIG. 17A) and the docking station connector 4914). Therefore, the extension 5000 can tilt during delivery to increase the flexibility of the catheter 3600 in the region of the docking station 10, while preventing the connection between the extension 5000 and the connector 4914 by contact at two points.

[0121] Referring to FIGS. 56, 57, 57A, and 57B, the head 5636 fits into the T-shaped recess 5710 of 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 outside the catheter (i.e., by retracting the outer tube / sleeve 4910 or advancing the connector 4914 (see FIG. 50D)). Referring to FIG. 56, the outer tube / sleeve 4910 of the catheter 3600 can be closely disposed 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 when the docking station expands. In this way, the delivery of the docking station 10 is controlled.

[0122] Referring again to FIG. 50D, at the end of the expansion of the docking station 10, when the distal end of the stent has finished expanding, the connector 4914 is moved relatively outside the outer sleeve. As a result, the head 5636 is free to move radially outward and disengages from the respective recess 5710 (see FIG. 56).

[0123] In one embodiment, the extensions 5000 are all of the same length. When the connector is moved relatively outside the outer tube / sleeve 4910, the recesses 5710 are simultaneously moved relatively outside the outer sleeve 4910. Since the extensions 5000 are all of the same length, the recesses 5710, together with the head 5636, all emerge from the delivery outer sleeve 4910 at the same time. As a result, the head 5636 of the docking station will move radially outward and be released all at once.

[0124] In an alternative embodiment, the docking station 10 includes an extension 5000 having a head 5636, and at least some of the extensions 5000 are longer than others. In this way, as the connector 4914 is gradually moved relatively outward from the outer sleeve 4910, the shortest extensions 5000 are first released from their respective recesses 5710. Next, as the connector 4914 is moved relatively further outside the outer sleeve 4910, the longer ones of the extensions 5000 are released from their respective recesses 5710. As described above, in an 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. Upon reaching the delivery site, the docking station 10 is deployed by moving the outer sleeve or tube 4910 towards the inner sleeve or tube 4912, as well as the 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 FIGS. 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 in order to deploy / position the docking station, for example.

[0125] In the example shown by FIGS. 58 to 61, the handle 5800 includes a housing 5810, a drive member 5812, and a driven shaft 5814. In the illustrated example, when the drive member 5812 rotates with respect to the housing 5810 as indicated by the arrow 5816, the driven shaft 5814 linearly moves as indicated by the arrow 5818. Referring to FIG. 60, the inner sleeve 4912 is fixedly connected to the housing 5810 as indicated by the arrow 6000, and the outer sleeve 4910 is fixedly connected to the driven shaft 5814 as indicated by the arrow 6002. Therefore, by rotating the drive member 5812 in the first direction, the outer sleeve 4910 is retracted with respect to the inner sleeve 4912, and by rotating the drive member 5812 in the opposite direction, the outer sleeve 4910 advances with respect to the inner sleeve 4912.

[0126] In the example shown by FIGS. 58 to 61, the housing 5810 includes an annular recess 5820. The drive member 5812 includes an annular protrusion 5822. The annular protrusion 5822 fits into the annular recess to rotatably connect the drive member 5812 to the housing 5810. The drive member 5812 includes an engagement portion 5830 extending from the housing that enables a user to rotate the drive member 5812 with respect to the housing 5810.

[0127] In the example shown by FIGS. 58 to 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 into the linear recess 5840 to slidably connect the driven shaft 5814 to the housing 5810.

[0128] In the example shown by FIGS. 58 to 61, the drive member 5812 includes a female thread 5850. The driven shaft 5814 includes a male thread portion 5852. The male thread portion 5852 meshes with the female thread 5850 to operably connect the drive member 5812 to the driven shaft 5814. That is, when the drive member 5812 is rotated with respect to the housing 5810 as shown by the arrow 5816, the rotation of the driven shaft 5814 is prevented by the linear protrusion 5842 that fits into the linear recess 5840. Therefore, when the drive member 5812 rotates within the housing 5810, since the engagement of the male thread portion 5852 meshes with the female thread 5850, as shown by the arrow 5818, the driven shaft 5814 linearly slides along the linear recess 5840. Since the outer shaft / tube 4910 is connected to the driven shaft 5814 and the inner shaft / tube 4912 is connected to the housing 5810, the rotation of the drive member 5812 causes the outer shaft / tube 4910 to be advanced and retracted with respect to the inner shaft / tube 4912.

[0129] In the example shown by FIGS. 58 to 61, the outer shaft / tube 4910 is fixedly connected, such as by a thread 5850, within a recess of 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. The luer port 5862 is fixedly connected to the housing 5810, for example, at the 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 guide wire 5002 (see FIG. 49) that extends through the inner shaft / tube 4912.

[0130] In the example shown by FIGS. 62 to 67, the handle 6200 includes a housing 6210, a drive wheel 6212, and a driven member 6214. In the illustrated example, as the drive wheel 6212 rotates relative to the housing 6210 as indicated by the arrow 6216, the driven member 6214 moves linearly as indicated by the arrow 6218 (compare the positions of the driven member 6214 in FIGS. 64A and 64B). Referring 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. Therefore, by rotating the drive wheel 6212 in the 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 advances relative to the inner sleeve / tube 4912. In various embodiments shown in FIGS. 58 to 73, the inner sleeve / tube 4912 is shown and described as being connected so as not to move relative to the handle or the proximal end of the handle, and the outer sleeve / tube 4910 is shown as being movable relative to the handle or the proximal end of the handle. However, in one embodiment using a similar concept, the inner sleeve / tube 4912 can be movable relative to the handle or the proximal end of the handle, and the outer sleeve / tube 4910 can be connected so as not to move relative to the handle or the 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 the proximal end of the handle.

[0131] In the example shown by FIGS. 62 to 67, the housing rotatably receives the axle 6822 of the drive wheel 6212 and rotatably couples 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] In the example shown by FIGS. 62 to 67, the housing 6210 includes a linear protrusion 6240 (see FIG. 66). The passive member 6214 includes a linear groove 6242 (see FIGS. 62 and 66) into which the protrusion 6240 fits to slidably connect the passive member 6214 to the housing 6210.

[0133] In the example shown by FIGS. 62 to 67, the drive member 6212 includes a pinion gear 6250. The passive member 6214 includes a rack gear portion 6252. The pinion gear 6250 meshes with the rack gear portion 6252 to operably connect the drive wheel 6212 to the passive member 6214. That is, when the drive wheel 621 is rotated relative to the housing 6210 as indicated by the arrow 6216, the passive member 6214 slides relative to the housing 6210 by the linear protrusion 6240 that fits into the linear groove or recess 6242. Therefore, when the drive member 6212 rotates relative to the housing 6210, the pinion gear 6250 drives the rack gear portion 6252 to linearly slide the passive member 6214 relative to the housing 6210 as indicated by the arrow 6218. Since the outer shaft / tube 4910 is connected to the passive member 6214 and the inner shaft / tube 4912 is connected to the housing 5810, the rotation of the drive wheel 6212 causes the outer shaft / tube 4910 to be advanced and retracted relative to the inner shaft / tube 4912.

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

[0135] Referring to FIG. 63, in an exemplary embodiment, the catheter 3600 can be cleaned by applying fluid, such as to the inner tube 4912, through the luer port 5862. As described above, the delivery catheter 3600 includes an outer lumen formed within the outer tube / sleeve 4910 and an inner lumen formed within the inner tube / sleeve 4912, and the inner lumen and inner tube 4912 are longitudinally coaxial with the outer lumen and outer tube 4910. The annular lumen / gap / space 6348 between the inner tube 4912 and the outer tube 4910 may be provided, for example, because a bent stent needs to be provided with a space to travel through the catheter 3600. This gap / space 6348 may initially be filled with air and later the air can be discharged and replaced with a liquid, such as a saline aqueous solution. In this way, cleaning can be performed using the various handle embodiments shown in FIGS. 58-73.

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

[0137] Since the gap / space 6348 is filled with fluid, air is pushed out of the delivery catheter through the distal end of the outer tube 4910. In an exemplary embodiment, the nose cone 28 is disengaged from the distal end of the outer tube 4910, allowing air to flow out of the outer tube and also out of the catheter 3600. Fluid also flows through the lumen of the inner tube 4912, pushing air out of the lumen. In an exemplary embodiment, air is expelled from the lumen through an opening 6390 at the end of the nose cone 28 (see FIGS. 49A and 49B). This cleaning procedure is performed before the delivery catheter 3600 is introduced into the body. By this device and method of approach, space is saved, for example, compared to providing side ports in the outer tube 4910 to introduce cleaning fluid into the delivery catheter assembly or the gap / space 6348.

[0138] Referring to FIGS. 68-73, in an exemplary embodiment, the handle 6200 shown in 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 configurations. In an exemplary embodiment, the ratchet mechanism 6800 is used while "recapturing" the docking station 10 and pulling it back into the delivery catheter 3600. The force required to recapture the docking station can be significant. 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 to pull the docking station 10 back into the outer tube / sleeve 4910. That is, the spring force of the docking station 10 is such that the ratchet mechanism 6800 prevents the docking station from being pulled out of the outer tube again. The operator can continuously recapture the docking station 10, for example, without allowing the docking station to reverse when the operator releases the drive wheel 6212.

[0139] Referring to FIGS. 68 - 71, one exemplary ratchet system uses a projection 6810 having a stop surface 6812 on one side of the projection and an inclined surface 6814 on the other side of the projection. FIGS. 68 - 71 show an engaged state where the ratchet arm 6892 engages with the projection 6810 such that the drive wheel 6212 can rotate in one direction and is positioned to prevent the drive wheel from pivoting in the opposite direction. For example, the ratchet arm 6892 can be configured to ride up on the inclined surface 6814 to allow the drive wheel 6212 to move in the retraction direction 6850. For example, the ratchet arm 6892 can be bent to ride up on the inclined inclined surface 6814. The stop surface 6812 is configured to engage the ratchet arm 6892 and prevent the drive wheel from rotating in the forward direction 6852. For example, the stop surface 6812 can be substantially orthogonal to the side surface 6870 of the drive wheel 6212 to prevent the ratchet arm from moving over the projection 6810.

[0140] FIGS. 72 and 73 show a ratchet mechanism 6800 where the ratchet arm 6892 is disengaged from the engagement with the projection 6810. Thereby, the drive wheel 6212 can be pivoted in either direction. For example, the ratchet mechanism 6800 can be arranged in an engaged - disengaged state such that the drive wheel 6212 can be pivoted in either direction when the docking station 10 is deployed.

[0141] In a ratchet system, it is common to place the ratchet teeth on the outer periphery of the wheel. By placing the teeth on the surface of the wheel, the diameter of the wheel can be reduced and space can be saved. Also, thereby, for example, instead of having a second wheel that engages with the first wheel for gripping, the outer periphery of the wheel can be used as a gripping portion for the thumb. 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, to prevent the arm 6892 from twisting when a force due to the movement of the wheel is applied to the arm, a portion of the arm can be bent so that it rides on a stabilizing bar 194 extending from the housing wall or is otherwise disposed within the housing.

[0143] FIGS. 74 - 90C show additional embodiments of the docking station 10 and the frame 1500 for the docking station. Any combination or sub - combination of features in the embodiments of FIGS. 74 - 90C, or any individual feature, can be used / combined with any combination or sub - combination of features in the embodiments of FIGS. 4A - 73, or any individual feature. The entire contents of U.S. Patent No. 10,363,130 and International Patent Application PCT / US2017 / 016587, both assigned to the same assignee, are incorporated herein by reference.

[0144] Next, referring to FIGS. 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 struts 1502, any number of cells 1504, or any number of vertices 1510, or the struts 1502 or cells 1504 can have any shape that fits pulmonary arteries of various sizes, shapes, and geometries. The struts 1502 can have any size, shape, thickness, or configuration that holds the valve 29 in place within the pulmonary artery PA. Additionally, 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 can include a lattice of compression members 1502 that extends from the proximal end 12 to the distal end 14 and defines the valve seat 18. Each compression member 1502 extends from the apex 1510 of the proximal end 12 to the nearest joint 1503, extends between adjacent joints 1503, and extends from the apex 1510 of the distal end 14 to the nearest joint 1503. Thus, each compression member 1502 connects to one or more other compression members 1502 at the joint 1503 and / or the apex 1510. The space surrounded by the joint 1503, the apex 1510, and the connected compression members 1502 defines a cell 1504. The compression members 1502 can be connected 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 stage 1506 is a circumferential row of compression members 1502 that extends from the apex 1510 of the proximal end 12 to the nearest joint 1503, a circumferential row of compression members 1502 that extends between adjacent joints 1503, and / or a circumferential row of compression members 1502 that extends from the apex 1510 of the distal end 14 to the nearest joint 1503. In the example shown by FIG. 74, the frame 1500 comprises four stages. Since the compression members 1502 repeat a converging portion where the joint 1503 tapers towards the proximal end 12 and a converging portion where the joint 1503 tapers towards the distal end 14, the cell 1504 is substantially diamond-shaped. In addition or alternatively, one or more compression members 1502 of one stage 1506 can be continuous with one or more compression members 1502 of a subsequent stage 1506. That is, rather than each compression member 1502 terminating on one side of the joint 1503 and another compression member starting on the other side of the joint, one or more of the compression members 1502 can be formed from a continuous strip of material simply connected to the adjacent compression members at the joint 1503.

[0146] As shown in FIGS. 74 - 75, the frame 1500 can have a height H extending 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 a point between the proximal end 12 where the docking station 10 seals the pulmonary artery and the valve seat 18.

[0147] Referring to FIGS. 74 and 75, the frame 1500 of the docking station 10 can have a different number of steps 1506. The number and configuration of the steps 1506 can be determined to provide better fixation, fit, or juxtaposition of the docking station 10 within the pulmonary artery PA. For example, the docking station 10 can include more steps 1506 for a longer pulmonary artery PA or when 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 steps 1506 and can have three rows of cells 1504. The frame 1500 can have a height H of 30 mm - 40 mm, such as 32 mm - 38 mm, for example 35 mm. The frame 1500 can have a seat diameter SD of 24 mm - 31 mm, such as 26 mm - 29 mm, for example 27 mm. The frame 1500 can have a seal width SW of 36 mm - 46 mm, such as 38 mm - 44 mm, for example 41 mm.

[0149] The frame 1500 of the docking station 10 can also be configured to fit pulmonary arteries that are longer and / or wider. 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 steps 1506 and can have five columns of cells 1504. The frame 1500 of the docking station 10 can have a height H of 45 mm to 51 mm, such as 48 mm, etc., 43 mm to 53 mm. The frame 1500 can have a seating diameter SD of 26 mm to 29 mm, such as 27 mm, etc., 24 mm to 31 mm. The frame 1500 can have a seal width SW of 46 mm to 52 mm, such as 48 mm to 50 mm, etc., 44 mm to 54 mm.

[0150] The frame 1500 has been described as having either four or six steps 1506, but the frame 1500 can have any suitable number of steps 1506 and any suitable number of columns of cells 1504. For example, the frame 1500 can have three, five, or seven or more steps 1506 and two, four, or six or more columns 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 not all of the cells 1504 are diamond-shaped.

[0151] Referring to FIGS. 76A-78B, the docking station 10 can be shaped or otherwise configured to better stabilize 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 vertices 1510 at the proximal end 12 and / or the distal end 14. The number of vertices 1510 can be determined to provide better fixation, fit, or juxtaposition of the docking station 10 within the pulmonary artery PA. For example, the docking station 10 can include more vertices 1510 in pulmonary arteries having a larger diameter or varying geometries.

[0152] As shown in FIGS. 76A-76C, the frame 1500 can be configured to include vertices 1510 at the proximal end 12 and 14 vertices 1510 at the distal end 14 that can provide better juxtaposition within the anatomical structure of the pulmonary artery PA. As shown in FIGS. 77A-77C, the frame 1500 can be configured to include vertices 1510 at the proximal end 12 and 12 vertices 1510 at the distal end 14 that can reduce the force required to bend the docking station 10 to conform it to a delivery device such as a catheter (e.g., catheter 3600 as shown in FIGS. 50A-50D), or can reduce the outward radial force exerted on the pulmonary artery PA by the docking station 10. Although the docking station 10 has been described as having either 12 or 14 vertices 1510, the docking station 10 can include any number of vertices 1510. For example, the docking station 10 can have 8-11 vertices 1510, such as 10 vertices 1510, 13 vertices, 15 or more vertices 1510, such as 16 vertices 1510, or any other arbitrary number of vertices 1510. Additionally, the docking station 10 can be configured such that the proximal end 12 and the distal end 14 have a different number of vertices 1510 to conform to 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 pulmonary artery tissue while 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 between 125° and 135°, such as about 130°, or between 120° and 140°. The compression member 1502 that defines the proximal and distal apexes 1510 can be curved, bent, or otherwise shaped such that the apex 1510 is radially outwardly flared to a position that maintains the docking station 10 within the pulmonary artery and reduces or minimizes trauma to the pulmonary artery tissue when the docking station 10 is deployed.

[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 rounded passages or openings that extend through the frame 1500 at the proximal end 12 and / or the distal end 14. As will be described later, 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 proximal end 12 or the distal end 14 or the apexes 1510 may not have an eyelet 1507, and the apex 1510 can be substantially solid and rounded. For example, in embodiments where the impermeable member 21 does not extend to the distal end 14 as described later, the apex 1510 at the distal end 14 may not include an eyelet 1507.

[0155] Frame 1500 can also include, as described above, one or more elongate legs or extensions 5000 and one or more heads 5636. The one or more elongate legs or extensions 5000 and the one or more heads 5636 can 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 opposite sides of the proximal end 12. However, the frame 1500 can include extensions 5000 and heads 5636 in any number and any suitable configuration. For example, the frame 1500 can include extensions 5000 and heads 5636 at the distal end 14, and / or the frame 1500 can have one or more than three heads 5636 at one or both of the ends 12, 14. The extensions 5000 and / or heads 5636 can be longer than the apex 1510 while remaining short enough to control the frame 1500 during deployment from the delivery device. For example, the extensions 5000 and / or heads 5636 can be 0.8 mm to 1.8 mm (or any particular length, or a sub-range of 0.8 mm to 1.8 mm) longer than the apex 1510, such as 1.3 mm longer than the apex, or can be 0.5 mm to 3.0 mm (or any particular length, or a sub-range of 0.5 mm to 3.0 mm) longer than the apex 1510.

[0156] As shown in FIGS. 78A and 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 to facilitate the flow of blood through the docking station 10 when the docking station 10 is deployed. The outflow cells 1508 can extend into the branches or bifurcations of the pulmonary artery when the docking station 10 is placed at a high position within the pulmonary artery. At least a portion of the outflow cells 1508 may not be covered by the impermeable material 21, and the outflow cells 1508 can form at least a part of the permeable portion 1400. The outflow cells 1508 can be larger than 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 compression members 1509 that define the outflow cell 1508 can be shaped or otherwise configured to define one of the distal ends or apexes 1510. The outflow compression member 1509 of each outflow cell 1508 can extend distally from two of the most distal junctions 1503 of the cells 1504. The outflow cells 1508 can increase the width and stability of the frame 1500 without significantly increasing the height of the frame 1500 when deployed. For example, the outflow cells can increase the height of the frame by less than 1 / 8 of the remaining height of the frame, or increase the height of the frame by less than 1 / 12 of the remaining height of the frame, or increase the height of the frame by less than 1 / 16 of the remaining height of the frame, or increase the height of the frame by less than 1 / 20 of the remaining height of the frame, or not increase the height of the frame at all.

[0157] In the illustrated embodiment, each outflow cell 1508 is partially defined by one outflow compression member 1509 that is bent to define one of the distal ends 1510. The ends of the outflow compression members 1509 are each attached to the most distal junction 1503 between two of the most distal cells 1504 and have one cell 1504 between the two cells 1504. In such an embodiment, the frame 1500 can include an inlet 1507 at the most distal junction 1503 of the cells 1504 where the outflow compression members 1509 are not attached. In such an embodiment, each outflow cell 1508 is defined by one outflow compression member 1509 and four compression members 1502.

[0158] As shown in FIGS. 78A and 78B, the outflow compression member 1509 can be bent, constricted, or otherwise shaped such that the distal portion of the outflow cell 1508 defines a narrow end 1513. The narrow end 1513 can help secure 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 outflow cells 1508 comprise the most distal row of cells. However, the frame 1500 can include outflow cells 1508 of any suitable configuration. For example, some but not all of the most distal row of cells can be outflow cells 1508, or the outflow cells 1508 can comprise two or more rows of cells.

[0160] Next, referring to FIG. 79, any of the frames 1500 described herein can be configured such that the deployment, recapture, and / or redeployment of the frame 1500 is easier. 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 position along the frame 1500. The maximum transition angle Θ defines the maximum angle between the tangents at the closure points along the frame 1500. For example, the maximum transition angle can be measured as the angle between the tangents at any two points spaced 0.1 mm apart along the contour of the frame. 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. The frame 1500 can be configured such that the maximum transition angle Θ is minimized and the large internal force within the frame 1500 required to compress the frame back into the catheter does not prevent the frame 1500 from being recaptured or redeployed. For example, the cross-section 1501 is shaped and configured such that the maximum transition angle Θ is less than 55°, less than 50°, for example 45°, etc., less than 60°.

[0161] Next, referring to FIGS. 80A, 80B, and 80C, the compression member 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 disposed within 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. In addition or alternatively, the frame can be configured such that the impermeable member 21 does not include additional stitching that may increase the radial resistance as described hereinafter. As shown in FIGS. 80A-80C, the compression member 1502 of the step 1506 near the valve seat 18 can have a greater thickness, or an increased cross-sectional width or diameter, than the compression member 1502 of other portions of the frame 1500. In the illustrated embodiment, the compression member 1502 of the two steps 1506 at the center of the frame 1500 (i.e., in the region of the valve seat 18) is thicker than the compression member 1502 of the other steps 1506. However, the frame 1500 of the docking station 10 can have various other configurations that provide a more resilient valve seat 18 or a greater radial force against the valve 29 when the valve 29 is disposed within the valve seat 18. For example, the compression member 1502 of any other step 1506 can also have an increased cross-sectional width or diameter, and not all of the compression members 1502 of the two central steps 1506 can have an increased cross-sectional width or diameter.

[0162] Docking station 10 has been described as having a thicker compression member 1502 that provides a more resilient valve seat 18 and / or applies a greater radial force against the deployed valve 29, or a compression member 1502 having an increased cross-sectional width or diameter. However, the docking station 10 can be configured in other ways to provide the same effect. For example, the portion of the compression member 1502 and / or the frame 1500 near the valve seat 18 can include a stronger, less elastic, and / or more resilient metal or material. The joint 1503 near the valve seat 18 can be stronger and / or thicker. Alternatively, the lattice structure of the frame 1500 can be made stronger near the valve seat 18 by increasing the number of compression members 1502 in the step 1506 near the valve seat 18 and decreasing the length, etc.

[0163] Next, referring to FIGS. 81A - 81D, the fabric or impermeable material 21 can be cut, configured, or otherwise shaped so that when the docking station 10 is compressed or deployed, the impermeable material 21 does not protrude and / or tear. The impermeable material 21 can be cut, configured, or otherwise shaped so 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 so 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 into 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 into the desired shape.

[0164] At the proximal end 12 and the distal end 14, the frame 1500 can include a plurality of openings 1511 between the compression member 1502 and the apex 1510 in a portion of the frame 1500 not defined by the cell 1504. The openings 1511 are generally triangular in shape and are partially defined by two compression members 1502, two apices 1510, and the junction 1503. The impermeable material 21 can be cut or shaped so that the impermeable material 21 does not cover at least a portion of the openings 1511 at the proximal end 12 and / or the distal end 14.

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

[0166] As shown in FIG. 81A, the impermeable material 21 can be shaped or cut so 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 so that the impermeable material 21 substantially covers each cell 1504 and substantially covers one-fourth, one-third, two-thirds, three-fourths, or any other suitable amount of each opening 1511 at the proximal end 12, and substantially covers one-fourth, one-third, two-thirds, three-fourths, 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 different sizes of cardiovascular anatomical structures. By removing a portion of the material 21 within the openings 1511 at the proximal end and / or the distal end, when the docking station is used within a smaller cardiovascular anatomical structure (e.g., FIG. 23B), the material 21 within the openings does not protrude or the protrusion is reduced.

[0167] As shown in FIG. 81B, the impermeable material 21 substantially covers each cell 1504, substantially covers three-fourths of each opening 1511 at the proximal end 12, and hardly covers the opening 1511 at the distal end 14.

[0168] As shown in FIG. 81C, the impermeable material 21 substantially covers each cell 1504, substantially covers the opening 1511 at the proximal end 12, and hardly covers the opening 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. Additionally, the impermeable material 21 has been described as covering the openings 1511 at the proximal end 12 in a uniform manner and covering the openings 1511 at the distal end 14 in a uniform manner. However, the impermeable material 21 can be cut or shaped so that the openings 1511 at each end 12, 14 are not covered in a uniform manner. For example, the openings 1511 at either end 12, 14 can be covered in a different manner or amount than the other openings 1511. Further, 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 detailed below.

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

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

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

[0173] Next, referring to FIGS. 82A - 85E, the impermeable material 21 can be attached to, fixed around, or otherwise adhered to the frame 1500 of the docking station 10 in various ways. For example, the impermeable material can be adhered to the frame 1500 using sewing or electrospinning, or the impermeable material 21 can be made from a seamless 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 to each other and then to the frame 1500. As shown in FIGS. 83 - 84I, the frame 1500 can include one or more eyelets 1507 at the apexes 1510 that can facilitate the attachment of the impermeable material 21 to the frame 1500. In the illustrated embodiment, each apex 1510 that does not include the elongated leg 5000 includes an eyelet 1507. However, the number of eyelets 1507 can vary, and each apex 1510 may include neither the elongated leg 5000 nor the eyelet 1507. For example, the apex 1510 at the distal end 14 may have neither an eyelet 1507 nor an elongated leg 5000.

[0175] As shown in FIGS. 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 that are fixed to each other 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 will be described in detail below, the first edges 1522, 1532 can be sized and shaped to conform to the valve seat 18 of the frame 1500, the second edge 1524 of the proximal portion 1520 can be sized and shaped to conform to the frame 1500 at a desired position 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 conform to the frame 1500 at a desired position 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 substantially in the shape of the apex 1510. However, the proximal portion 1520 and the distal portion 1530 can be shaped in a 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 FIGS. 81A - 81D.

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

[0178] As shown in FIG. 82D, the first end 1536 of the distal portion 1530 can be folded or looped and secured to the second end 1538 of the distal portion 1530 to form the 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 stitching with thread or suture, by an adhesive, by a fastener, or by any other suitable means.

[0179] As shown in FIGS. 82E - 82I, the proximal portion 1520 can be fixed to the distal portion 1530 such that the second edge 1524 of the proximal portion 1520 is on the opposite side of the second edge 1534 of the distal portion 1530. The first edge 1522 of the proximal portion 1520 can overlap with the 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 fixed. By offsetting the proximal portion joint 1525 and the distal portion joint 1535, the simplicity of manufacturing the impermeable member 21 can be increased and / or the strength and elasticity of the impermeable member 21 can be increased. The proximal portion joint 1525 can be offset from the distal portion joint 1535 such that the proximal portion joint 1525 is aligned with one of the apex 1510 and / or the joint 1503 and the distal portion joint 1535 is aligned with the other of the apex 1510 and / or the joint 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 fixed to the distal portion 1530 in any suitable manner. For example, the first edge 1522 of the proximal portion 1520 can be fixed to the first edge 1532 of the distal portion 1530 by sewing with a thread or suture, by an adhesive, by a fastener, or by any other suitable means.

[0181] In one embodiment, the proximal portion 1520 and the distal portion 1530 each include a plurality of apertures 1540 along a first edge 1522, 1532, a first end 1526, 1536, and a second end 1528, 1538. The apertures 1540 may facilitate the assembly of the impermeable material 21, such as by serving as a guide for suture or thread to be passed therethrough. The apertures 1540 can be formed by any suitable process, such as cutting or laser drilling.

[0182] As shown in FIGS. 82E - 82I, the proximal portion 1520 can be attached to the distal portion 1530 near the inner joint 1542 by an interlock stitch that provides a radial force opposing the valve 29 when the valve 29 is disposed within 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. A suture 1560 can be passed through the proximal portion 1520 and the distal portion 1530 (radially inwardly) between the first edges 1522, 1532 at a first point 1543a. The suture 1560 can then be returned by passing through the proximal portion 1520 and the distal portion 1530 in the opposite direction (radially outwardly) at a second point 1543b that is circumferentially spaced from the first point 1543a. The suture 1560 can then repeatedly pass in and out through the proximal portion 1520 and the distal portion 1530 at other points 1543 until the suture 1560 is substantially passed around the circumference of the proximal portion 1520 and the distal portion 1530.

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

[0184] As shown in FIGS. 82J and 82K, proximal portion 1520 and distal portion 1530 can be cut, shaped, or otherwise formed from one or more pieces of fabric 23. Fabric 23 can include fibers 24 that are disposed substantially vertically and horizontally when fabric 23 is vertically oriented. In the illustrated embodiment, proximal portion 1520 and distal portion 1530 are cut from the same fabric 23. However, proximal portion 1520 can be cut from a first fabric 23 and 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 the 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 having fibers oriented at the angle β can be selected. 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 the assembly of the impermeable member 21 and the attachment of the impermeable member 21 to the frame 1500. In one embodiment, as shown in FIG. 82J, the proximal portion 1520 can be cut such that the angle β is about 90°. In another embodiment, as shown in FIG. 82K, the proximal portion 1520 can be cut such that the angle β is between 30° and 50°, such as 45°, or between 20° and 70°.

[0186] The distal portion 1530 can be cut from the fabric 23 such that the 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 having fibers oriented at the angle Δ can be selected. 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 the assembly of the impermeable member 21 and the attachment of the impermeable member 21 to the frame 1500. In one embodiment, as shown in FIG. 82J, the distal portion 1530 can be cut such that the angle Δ is about 90°. In another embodiment, as shown in FIG. 82K, the distal portion 1530 can be cut such that the angle Δ is between 30° and 50°, such as 45°, or between 20° and 70°.

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

[0188] As shown in FIG. 83, the impermeable material 21 can be properly 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 member 1502, joint 1503, and / or apex 1510 near the proximal end 12, and the second edge 1534 of the distal portion 1530 is substantially aligned with the desired compression member 1502, joint 1503, and / or apex 1510 near the distal end 14. In the illustrated embodiment, the impermeable material 21 extends from the proximal end 12 to the distal end 14 of the frame 1500 and does not extend to the outermost distal row of cells 1504. The impermeable material 21 can also be configured such that the impermeable material 21 does not cover the opening 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 opening 1511 near the ends 12, 14 in any amount or configuration, such as the configurations illustrated and described in FIGS. 81A - 81D.

[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 elasticity of the docking station 10 or facilitate attachment of the impermeable member 21 to the frame 1500. As shown by the dashed 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 joint 1503. In the illustrated embodiment, the proximal portion joint 1525 and the distal portion joint 1535 are aligned with the joint 1503 but not with any of the apices 1510. However, the proximal portion joint 1525 and the distal portion joint 1535 can be arranged and / or configured in various ways. For example, one or both of the proximal portion joint 1525 and the distal portion joint 1535 can be aligned with one of the apices 1510, respectively.

[0190] Next, referring to FIGS. 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 side step 1506, apex 1510, or junction 1503. One or more threads or sutures 1560 can be sutured to or looped around the compression member 1502 of the most proximal step 1506. At a point near the most proximal junction 1503 where the impermeable material 21 extends to, the suture 1560 can be passed through the impermeable material 21, looped around the compression member 1502, and passed back through the impermeable material 21 on the other side of the compression member 1502. This stitch can be repeated until the suture 1560 extends substantially along the length of the compression member 1502. Near the apex 1510, the stitch can be repeated such that the suture 1560 passes down the compression member 1502 following the step until the suture 1560 extends substantially to the junction 1503. This stitch can be repeated until the suture 1560 extends substantially along each compression member 1502 of the most proximal step 1506 and the suture 1560 extends substantially circumferentially around the frame 1500.

[0191] As shown in FIGS. 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 the distal portion of the impermeable material 21 is aligned with the desired distal side step 1506, apex 1510, or junction 1503. In the illustrated embodiment, at a point near the junction 1503 that defines the proximal end of the most distal cell 1504, the suture 1560 can be passed through the impermeable material 21, looped around the compression member 1502, and returned through the impermeable material 21 on the other side of the compression member 1502. This stitch can be repeated until the suture 1560 extends substantially along the length of the compression member 1502. Near the most distal junction 1503 to which the impermeable material 21 extends, the stitch can be repeated such that the suture 1560 passes down the compression member 1502 following the step 1506 until the suture 1560 extends substantially to the junction 1503. This stitch can be repeated until the suture 1560 extends substantially along each compression member 1502 of the most distal step 1506 to which the impermeable material 21 extends and the suture 1560 extends substantially circumferentially around the frame 1500.

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

[0193] As shown in FIG. 84C, the impermeable material 21 can be further fixed to the frame 1500 with one or more vertical stitches 1544. The suture 1560 is sewn around one of the compression materials 1502 of the proximal stage 1506. After the suture 1560 substantially extends from the joint 1503 to the apex 1510, the suture 1560 can be passed 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 can then be sewn around the compression material 1502 that descends toward the joint 1503. The vertical stitch 1544 has been illustrated only as fixing the impermeable material 21 to the eyelet 1507 at the apex 1510 of the proximal end 12, but the vertical stitch 1544 can be used at other positions of the frame 1500. For example, the vertical stitch 1544 can be used in an embodiment where the impermeable material 21 extends to the apex 1510 at the distal end 14, or in an embodiment where the frame 1500 includes an outflow cell 1508 and the impermeable material 21 extends to the apex 1510 near the distal end 14. However, the impermeable material 21 may not be fixed to the frame 1500 with one or more vertical stitches (e.g., FIG. 84I).

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

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

[0196] As shown in FIG. 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 position and in substantial contact with one or more compression members 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 compression member 1502, joint 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 compression member 1502, joint 1503, and / or apex 1510 near the distal end 14. The nozzle 1569 can be positioned above and facing the impermeable material 21 and 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 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 the opening of the nozzle 1569 is directed toward the compression member 1502 and the impermeable material 21. As shown in FIG. 85C, the 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 side surface of the compression member 1502. As shown in FIG. 85E, more coating and / or adhesive 1570 is deposited onto 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 can then be dried, cured, or otherwise solidified, thereby substantially fixing the impermeable material 21 to the frame 1500.

[0198] The coating and / or adhesive 1570 can be sprayed or otherwise deposited onto 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 step 1506 that aligns with the second edges 1524, 1534 of the impermeable material 21. However, the coating and / or adhesive 1570 can be deposited in any suitable manner to fix the impermeable material 21 to the frame 1500. For example, the coating and / or adhesive 1570 can be deposited only at specific locations along the step 1506, such as only at the joints 1503 and the vertices 1510.

[0199] Next, referring to FIGS. 86A - 89D, the docking station 10 can include one or more radiopaque markers 1580 that can assist in the deployment of the docking station 10 and the placement of the valve 29 within the valve seat 18. The one or more radiopaque markers 1580 can be radiopaque or have a high degree of radiopacity so 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 by a variety of techniques such as those detailed below. The one or more radiopaque markers 1580 can include any material or combination of materials that is radiopaque or that increases 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 - 86D, the radiopaque marker 1580 is disk - shaped and can be circular or octagonal. However, the one or more radiopaque markers 1580 can be configured to reduce axial movement and can be of any suitable shape. For example, the one or more radiopaque markers 1580 can be hexagonal, triangular, rectangular, elliptical, 3D, or any other shape or configuration. The radiopaque marker 1580 can also include an aperture 1582 that extends through the central portion of the marker 1580. The aperture 1582 can be sized to allow a suture thread 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 embodiments, the radiopaque marker 1580 can be attached or affixed to a compression member 1502 or joint 1503 within the valve seat 18 of the frame 1500, and the radiopaque marker 1580 is attached to the frame 1500 in any suitable manner. For example, the radiopaque marker 1580 can be attached to the frame 1500 by an adhesive, suture, press fit, snap fit, or any other suitable means. The frame 1500 can include three or more radiopaque markers 1580 that are circumferentially spaced around the valve seat 18 to establish an annular plane passing through the valve seat 18 of the docking station 10. However, the frame 1500 can include fewer than three radiopaque markers 1580. In other embodiments, the radiopaque marker 1580 can be attached or affixed to the impermeable material 21 as further described anywhere in this disclosure, and the radiopaque marker 1580 is attached or affixed at or near the compression member 1502 or joint 1503 of the frame 1500, or is attached or affixed away from the compression member 1502 and joint 1503 of the frame 1500.

[0201] As shown in FIGS. 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 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] As shown in FIG. 88, one or more radiopaque markers 1580 can be disposed on one or more marker settings 1584 and fixed by any suitable means. For example, one or more radiopaque markers 1580 can be fixed to one or more marker settings 1584 by press fitting, snap fitting, adhesives, fasteners, or any other suitable method.

[0203] In addition or alternatively, as shown in FIGS. 89A - 89D, when the impermeable material 21 is attached to the frame 1500, one or more radiopaque markers 1580 can be included in the impermeable material 21 such that one or more radiopaque markers 1580 are disposed within the valve seat 18. One or more radiopaque markers 1580 can be sewn on top, sewn inside, enclosed in a pocket, or attached to the impermeable material 21 in another way such that one or more radiopaque markers 1580 are disposed around the valve seat 18 when the impermeable material 21 is disposed on the frame 1500.

[0204] The radiopaque marker 1580 can be attached or adhered to the compression member 1502 and the joint 1503 of the frame at various positions. In some implementations, the radiopaque marker 1580 can be attached or adhered to or near the compression member 1502 or the joint 1503 of the frame 1500. In a particular implementation, the radiopaque marker 1580 can be attached or adhered away from the compression member 1502 and the joint 1503 of the frame 1500, such as at a position within the central portion of the cell 1504 of the frame. Positioning the radiopaque marker 1580 within the central portion of the cell 1504 can provide certain technical advantages. One technical advantage is that the overlap between the radiopaque marker 1580 and the associated attachment material and the compression member 1502 and the joint 1503 of the frame 1500 can be minimized, thereby reducing the bent profile of the frame 1500. Another technical advantage is that the 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 by being disposed within the central portion of the cell 1504, the radiopaque marker 1580 can be allowed to move radially outward to accommodate the expansion of the valve 29 within the frame 1500, thereby minimizing the physical contact between the frame 712 of the valve 29 and the frame 1500 and avoiding interference with the proper function of the valve 29.

[0205] As shown in FIG. 89A, one or more radiopaque markers 1580 can be sewn into the impermeable material 21 inside or near any inner joint 1542 when the proximal portion 1520 is attached to the distal portion 1530. For example, the radiopaque marker 1580 can be attached to the impermeable material 21 by passing a suture 1560 through an aperture 1582. One or more radiopaque markers 1580 can also be sewn onto the impermeable material 21 inside or near the inner joint 1542 after the proximal portion 1520 has been 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 so that the radiopaque marker does not interfere with the valve 29 when the valve 29 is disposed within the valve seat 18. However, one or more radiopaque markers 1580 can also be attached inside the impermeable material 21.

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

[0207] 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, alternatively, the pockets 1586 can extend radially inward from the remainder of the impermeable material 21. The pockets 1586 can be part of or near an 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 a pocket 1586 is formed when the proximal portion 1520 is attached to the distal portion 1530. The pockets 1586 can be formed from additional material or patches added to the proximal portion 1520 and / or the distal portion 1530, or can be formed from additional impermeable material 21 attached to a region defined by the proximal portion 1520 and / or the distal portion 1530. One or more pockets 1586 can be spaced around the impermeable material 21 at or near the inner joint 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 fixed within the pocket 1586. In one embodiment, the radiopaque marker 1580 is disposed within the pocket 1586 before the radiopaque material 21 is attached to the frame 1500. The pocket 1586 can then be covered by one or more pocket coverings 1588, the pocket can be sewn closed, and / or stitches can be passed through the radiopaque marker to secure the marker within the pocket. Any pocket covering 1588 can be sized and shaped to cover the opening of the pocket 1586 and can include the same material as the radiopaque material 21. The pocket covering 1588 can be attached to the radiopaque material 21 on the side opposite the frame 1500 of the radiopaque material 21. The pocket covering 1588 can be attached to the radiopaque material 21 by one or more suture threads 1560. Alternatively, the pocket 1586 can be formed by attaching the pocket covering 1588 to the radiopaque material 21, thereby defining the pocket 1586 as the space between the pocket covering 1588 and the radiopaque member 21.

[0209] Referring to FIGS. 89C and 89D, the suture thread 1560 can attach the pocket covering 1588 to the radiopaque material 21 around the outside of the pocket covering 1588 and can include support stitches 1589 that extend across the pocket covering 1588. The support stitches 1589 can provide a radial force that opposes the valve 29 when the valve 29 is disposed within the valve seat 18. The support stitches 1589 can be along or parallel to the inner joint 1542 (FIG. 89C) or perpendicular to the inner joint 1542 (FIG. 89D).

[0210] Referring to FIGS. 89E to 89N, an X-ray impermeable marker 1580 having an arbitrary aperture 1582 can be disposed and fixed within a pocket 1586 of the impermeable member 21 (since the pocket 1586 is formed between the pocket covering 1588 and the impermeable member 21, not shown). The X-ray impermeable marker 1580 can be fixed within the pocket 1586 in such a manner that it can increase the fixation of the X-ray impermeable marker 1580 and reduce the translational and rotational movement of the X-ray impermeable marker 1580. As shown in FIGS. 89E and 89F, the pocket covering 1588 can be disposed on the impermeable material 21 and can be partially fixed to the impermeable material 21 by suture threads 1560. The suture threads 1560 can be sewn around a portion of the pocket covering 1588 so that a portion of the pocket covering 1588 is not fixed to the impermeable member 21, thereby partially fixing the pocket covering 1588 to the impermeable member 21. The suture threads 1560 can be passed through the pocket covering 1588 and the impermeable member 21 at a plurality of penetration points 1591. The penetration points 1591 can be near the edge of the pocket covering 1588 and can substantially surround the periphery of the pocket covering 1588. For example, the suture threads 1560 can be passed through the penetration points 1591 to surround three-quarters of the periphery of the pocket covering 1588. In the illustrated embodiment, the suture threads 1560 are sewn through the penetration points 1591 by stitch-in and stitch-out stitches. However, the suture threads 1560 can be sewn through the penetration points 1591 by any suitable stitch.

[0211] As shown in FIG. 89G, the radiopaque marker 1580 can then be disposed within a pocket 1586 formed between the radiopaque 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 radiopaque member 21. As shown in FIG. 89H, the remainder of the pocket covering 1588 can be secured to the radiopaque member 21 by suture 1560. The suture 1560 can be passed through additional penetration points 1591 such that the suture 1560 substantially surrounds the radiopaque marker 1580 near the edge of the pocket covering 1588. The suture 1560 can be passed through the pocket covering 1588 and the radiopaque member 21 such that the suture 1560 passes through the first penetration point 1591. Optionally, as shown in FIG. 89H, the suture 1560 can be passed through and returned through the penetration point 1591 to create an interlock stitch 1590 similar to the stitches described in FIGS. 82E-82I.

[0212] The pocket covering 1588 has been described as being partially sewn to the radiopaque member 21 before the radiopaque marker 1580 is disposed within the pocket 1586, but the pocket covering 1588 can be attached to the radiopaque member 21 by other means. For example, the radiopaque marker 1580 can be disposed between the pocket covering 1588 and the radiopaque member 21, and the pocket covering 1588 can then be sewn to the radiopaque member 21.

[0213] Referring to FIGS. 89I - 89L, the radiopaque marker 1580 can further be fixed within the pocket 1586 by cross - stitching. The suture 1560 can be stitched from one of the penetration points 1591 to the opposite penetration point 1591 of the pocket covering 1588, and can also pass through the penetration point 1591 at the center of the pocket covering 1588. The central penetration point 1591 can 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. 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 also further be fixed within the pocket 1586 by a second cross - stitch. The second cross - stitch of the suture 1560 can extend from one of the penetration points 1591 to the opposite penetration point 1591 of the pocket covering 1588, and can also pass through the penetration point 1591 at the center of the pocket covering 1588. This second stitch passing through the central penetration point 1591 can be substantially perpendicular to the first cross - stitch extending across the pocket covering 1588 and passing through the central penetration point 1591. Thus, the suture 1560 can form a "+" or "X" shape across the pocket covering 1588. However, the suture 1560 can be stitched in any shape to fix the radiopaque marker 1580 within the pocket 1586 and can include more than two stitches extending through the central penetration point 1591.

[0215] As shown in FIGS. 90A - 90C, instead of being separate pieces attached to the frame 1500 or the impermeable material 21, one or more radiopaque markers 1580 are included in the frame 1500. The radiopaque marker 1580 can be incorporated into the frame 1500, or the radiopaque marker 1580 can be a thicker frame joint 1503 within 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 where the frame 1500 includes nitinol, additional nitinol can be deposited at the frame joint 1503 within the valve seat 18 to increase the radiopacity or radiodensity of the valve seat 18. However, the radiopacity or radiodensity of the frame joint 1503 within the valve seat 18 can be increased by various other means, such as depositing additional and / or different radiopaque materials at one or more of the frame joints 1503 within the valve seat 18.

[0216] In addition or alternatively, the radiopacity of the valve seat 18 can be increased by using a radiopaque material or a material that increases radiopacity for the impermeable material 21. For example, the proximal portion 1520 can include a radiopaque material or a material that increases radiopacity near the first edge 1522 such that the radiopacity of the impermeable material 21 increases at or near the inner joint 1542, and / or the distal portion 1530 can include a radiopaque material or a material that increases radiopacity near the first edge 1532. 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 increases. Thus, when the impermeable material 21 is attached to the frame 1500, the radiopacity of the valve seat 18 of the docking station 10 can be increased.

[0217] By including additional radiopaque materials or otherwise, the use of a radiopaque marker 1580 or portion with increased radiopacity or radiation concentration can facilitate the 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, a radiopaque marker 1580 or portion with increased radiopacity or radiation concentration of the frame 1500 can be used so that the THV or valve 29 can be properly deployed within the docking station 10 or the docking station frame 1500, such as within the valve seat 18. The valve 29 can be deployed such that the central or center 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 the marker setting 1584 (FIG. 88), attached to the impermeable material (FIG. 89A), disposed within a pocket 1586 disposed within the impermeable material 21 (FIG. 89B), or any other suitable method is possible. 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 also be constructed or configured such that it is visible under fluoroscopy or a similar imaging process. In addition or alternatively, the valve 29 can include a radiopaque marker or portion with increased radiopacity or radiation concentration similar to the radiopaque marker 1580 of the frame 1500 described above. For example, the valve 29 can include a radiopaque marker disposed at the center or central portion of the valve 29.

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

[0219] Frame 1500 has been described as including radiopaque markers 1580 to position and reposition valve 29 for deployment within valve seat 18 of frame 1500, but the positioning of valve 29 within frame 1500 can be done by any other suitable method of position identification. For example, frame 1500 can include a thicker frame junction 1503 in valve seat 18, include additional nitinol in frame junction 1503, deposit additional and / or different radiopaque materials on one or more frame junctions 1503 of valve seat 18, or include portions of valve seat 18 with increased radiopacity or radiation density by any other suitable method.

[0220] Referring to FIGS. 91-96B, radiopaque markers or portions with increased radiopaque or radiation density can also be used to deploy the docking station 10 or the 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 radiopaque or radiation density that can be seen under fluoroscopy or a similar imaging process and used for the deployment, positioning, recapture, and / or redeployment of the frame 1500. The elongated nose cone 28 can have increased radiopacity or radiation density so that at least a portion of the elongated nose cone 28 can be identified under fluoroscopy or a similar imaging process. For example, the elongated nose cone 28 can at least partially include barium sulfate to increase the radiopacity of the nose cone 28. However, any material that provides radiopacity can be used.

[0221] As shown in FIGS. 92A - 92C, the outer tube 4910 of the delivery catheter 3600 has a terminal or distal end 4911 near the nose cone 28 when the delivery catheter 3600 is in a compact or undeployed state, and as will be described later, the frame 1500 can be deployed therefrom. 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 radiation density at the distal end 4911 or its vicinity. The radiopaque marker 4920 can be of any suitable size, shape, configuration, or composition, such as any of the radiopaque markers described above herein. The radiopaque marker 4920 can be configured and positioned to indicate the amount of the frame 1500 that has been deployed, as will be detailed below. Optionally, the outer tube 4910 can include an end cap 4913 disposed at the 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. In addition or alternatively, the end cap 4913 can be constructed of a material with increased radiopacity or radiation density such that the end cap 4913 is visible or distinguishable under fluoroscopy or a similar imaging process. As shown in FIG. 92B, the proximal end of the nose cone 28 can extend at least partially into the end cap 4913.

[0222] As shown in FIGS. 92A and 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 attached to the tube in another way. The radiopaque marker 4920 can include any suitable material that is radiopaque or has an increased radiation density, 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 radially inside the end cap 4913.

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

[0224] The radiopacity or radiation density near the distal end 4911 of the outer tube 4910 has been described as being increased by including one or more radiopaque markers 4920, but the radiopacity or radiation density can be increased by other means. For example, the end cap 4913 can at least partially include a material with increased radiopacity or radiation density, or additional and / or different materials can be deposited around the distal end 4911 to increase the radiopacity or radiation density.

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

[0226] The connection tube 4916 can include one or more radiopaque markers 4922 disposed along the length of the connection tube 4916 to increase radiopacity or radiation density. The one or more radiopaque markers 4922 can be spaced along the connection tube 4916 at a fixed or predetermined distance from the nose cone 28 and / or the docking station connector 4914 to provide positioning and / or deployment information. The position or positioning of the radiopaque marker 4922 can be selected to indicate or identify the 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 connection tube does not include any radiopaque markers. In an exemplary embodiment, the connection tube 4916 includes one or more radiopaque markers, but the outer tube 4910 does not include any radiopaque markers. In an exemplary embodiment, the connection tube 4916 includes one or more radiopaque markers and the outer tube 4910 includes one or more radiopaque markers. Any combination of the nose cone, outer tube, connection tube, docking station, and valve can include one or more radiopaque markers to assist in the deployment of the docking station and / or valve.

[0227] Referring to the embodiments shown in FIGS. 93A - 93C, the connection tube 4916 includes one radiopaque marker 4922 as a band disposed around the connection tube 4916. However, the connection tube 4916 can have any number, positioning, or configuration of radiopaque markers 4922. For example, the connection tube 4916 can have two radiopaque markers 4922 (FIG. 94) or three or more radiopaque markers 4922 disposed at different lengths along the connection tube 4916, and the radiopaque markers 4922 can be similar to the radiopaque markers 1580 described in FIGS. 86A - 86D. In addition or alternatively, the connection tube 4916 can be made radiopaque or have its radiation concentration increased by other suitable means. For example, the radiopacity or radiation concentration of a portion of the connection tube 4916 can be achieved by depositing additional and / or different radiopaque materials along the connection tube 4916, or by at least partially constructing a portion of the connection tube 4916 from a material with high radiopacity or radiation concentration.

[0228] As shown in FIG. 94, the frame 1500 can be disposed around the connection tube 4916 between the nose cone 28 and the docking station connector 4914 in a compressed or undeployed state. The outer tube 4910 can be retracted relative to the nose cone 28, the connection 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 ways. For example, the frame 1500 can be coupled to the catheter assembly using a lock, a latching mechanism, suture threads (e.g., one or more suture threads that are releasably attached, tied, or woven through one or more portions of the docking station), an interlock device, combinations thereof, or other attachment mechanisms. Some of these coupling or attachment mechanisms can be configured such that the frame can be retracted back into the catheter assembly without catching on the edge of the catheter assembly, for example, by constraining the proximal end of the docking station to a smaller profile or a folded configuration to allow for adjustment, removal, repositioning, etc. of the docking station.

[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 elongated legs 5000 that can connect the frame 1500 to the docking station connector 4914. The elongated legs 5000 can be the securing portion of the proximal end 12 of the frame 1500 that is longer than the remainder of the securing portion 414. The illustrated elongated legs 5000 include a head 5636 that can be secured within the T-shaped recess 5710 of the docking station connector 4914 to at least partially connect the frame 1500 to the delivery catheter assembly during deployment of the frame 1500. The head 5636 of the elongated legs 5000 can be secured within the T-shaped recess 5710 when the outer tube 4910 is withdrawn and the remainder of the frame 1500 expands. When the remainder of the frame 1500 is deployed, the head 5636 of the elongated legs 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 by any other means, such as any of the other means described hereinabove.

[0230] As shown in FIG. 94, the frame 1500 can be disposed within the outer tube 4910 and around the connection tube 4916, and the radiopaque marker 4922 of the connection tube 4916 is disposed along the length of the frame 1500. The radiopaque marker 4922 can be disposed along the connection tube 4916 so as to correspond to a predetermined point on the frame 1500. The radiopaque marker 4922 can be positioned along the connection tube 4916 so as to correspond to various amounts of deployment of the frame 1500, as will be described later. In the illustrated embodiment, the connection tube 4916 includes two spaced-apart radiopaque markers 4922 disposed along the length of the axis. However, the connection tube 4916 can have radiopaque markers 4922 of any number, shape, size, or configuration. For example, the connection 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 connection tube 4916.

[0231] As shown in FIGS. 95A - 95C, the outer tube 4910 can be withdrawn from the rest of the delivery catheter assembly to expose and deploy the frame 1500. In the illustrated example, the frame 1500 includes an impermeable member 21 and one or more radiopaque markers 1580 within the valve seat 18 that are exposed as the outer tube 4910 is withdrawn 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 can be seen under fluoroscopy or similar image processing 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 of the ways described herein. For example, the radiopaque markers 1580 can be disposed within a marker setting 1584 (FIG. 88), attached to an impermeable material (FIGS. 89A, 95C), disposed within a pocket 1586 disposed within the impermeable member 21 (FIG. 89B), or disposed on the joint 1503 of the frame 1500 by any other suitable means such as. Alternatively, the radiopacity or radiation density of one or more portions of the valve seat 18 can be increased in any other suitable way. For example, the frame 1500 can include a thicker frame joint 1503 in the valve seat 18, include additional nitinol in the frame joint 1503, deposit additional and / or different radiopaque materials on one or more frame joints 1503 of the valve seat 18, or include portions of the valve seat 18 with increased radiopacity or radiation density by any other suitable means such as.

[0232] The radiopaque marker 1580 of the frame 1500, one or more radiopaque markers 4920 of the outer tube 4910, one or more radiopaque markers 4922 of the connecting tube 4916, and / or the radiopaque nose cone 28 can be used to facilitate deployment of the docking station frame 1500 at an appropriate position, such as an appropriate position within the pulmonary artery, an appropriate position within the mitral valve, an appropriate position within the tricuspid valve, or an appropriate position of any part of the vasculature.

[0233] As shown in FIG. 95A, the outer tube 4910 can be withdrawn or pulled out from the rest of the delivery catheter assembly such that the distal end 14 of the frame 1500 is no longer received within the outer tube 4910. The exposed portion of the frame 1500 begins to expand outside of the outer tube 4910. As the distal portion of the frame 1500 begins to expand outside 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 towards the distal end of the outer tube, but remain disposed within the outer tube 4910. The frame 1500 also remains connected to the delivery catheter assembly. For example, the head 5636 of one or more elongated legs 5000 of the frame 1500 can be held 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 withdrawing the rest of the delivery catheter assembly within the outer tube 4910.

[0234] As shown in FIG. 95B, the radiopaque marker 1580 within the valve seat 18 of the frame 1500 is substantially aligned with the radiopaque marker 4920 at the distal end 4911 of the outer tube 4910, such that the outer tube 4910 can be further withdrawn or pulled out from the remainder of the delivery catheter assembly. In such a position, the frame 1500 can be disposed about 50% or semi-deployed from the outer tube 4910. One or more radiopaque markers 4922 on the connection 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 head 5636 of one or more elongate legs 5000 being secured by the docking station connector 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 alternatively the remainder of the delivery catheter assembly can be withdrawn within the outer tube 4910. The alignment of the radiopaque marker 1580 of the frame 1500 with one or more radiopaque markers 4920 of the outer tube 4910 can indicate at which point the entire frame 1500 should be deployed or recaptured, repositioned, and redeployed from within the outer tube 4910. That is, the radiopaque marker 1580 of the frame 1500, and 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] As shown in FIG. 95C, the outer tube 4910 can be further withdrawn or pulled out from the rest of the delivery catheter assembly. The docking station frame 1500 extends outside the outer tube 4910 except that one or more elongated legs 5000 can be held by the docking station connector 4914 within 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] When the frame 1500 is in the desired position, the outer tube 4910 can be further withdrawn 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 withdrawn such that the radiopaque marker 4920 at the distal end 4911 of the outer tube 4910 is proximal to one or more radiopaque markers 4922 of the connection tube 4916, so that the radiopaque markers 4922 of the connection tube 4916 are deployed.

[0237] The radiopaque markers 4922 of the connection tube 4916 and / or one or more radiopaque markers 4920 of the outer tube 4910 can be spaced or positioned in any suitable manner. For example, at such positions, one of the radiopaque markers 4922 of the connection tube 4916 can be positioned on the connection tube 4916 and spaced from the radiopaque marker 4920 of the outer tube 4910 (i.e., at a position between the positions shown by FIGS. 95B and 95C) so as to be substantially aligned. For example, when viewed under fluoroscopy or a similar imaging process, the alignment of one of the radiopaque markers 4922 of the connection tube 4916 and one of the radiopaque markers 4920 of the outer tube 4910 can indicate the final position where the frame 1500 can be retracted into the outer tube 4910.

[0238] As shown in FIGS. 96A and 96B, the radiopaque nose cone 28, one or more radiopaque markers 4920 of the outer tube 4910, the radiopaque marker 1580 of the frame 1500, and one or more radiopaque markers 4922 of the connection tube 4916 can be seen under fluoroscopy or other imaging processes and monitored during the deployment of the frame 1500. The frame 1500, the connection tube 4916, the docking station connector 4914, and the inner tube 4912 can optionally be seen under fluoroscopy or a similar imaging process, but are not as distinct as the radiopaque markers. In FIGS. 96A and 96B, the frame 1500 is shown by a dashed line indicating the position of the frame in the drawing, indicating that the frame may not be visible 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 by which the frame 1500 is deployed or extended. For example, the radiopaque markers 1580, 4920 can be used to position and deploy the frame at a desired location within the vasculature. Additionally, the radiopaque markers 4920, 4922 can be used to monitor the frame 1500 when it can still be retracted back into the outer tube (i.e., when marker 4922 has not moved distally beyond marker 4920). For example, the amount of deployment of the frame 1500 indicated by the alignment of markers 4920, 4922 can represent the amount or degree of deployment corresponding to the maximum amount of deployment before the frame 1500 can no longer be recaptured by the outer tube 4910.

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

[0241] While deploying the frame 1500, the positions of the radiopaque marker 1580 of the frame 1500, one or more radiopaque markers 4920 of the outer tube 4910, one or more radiopaque markers 4922 of the connection tube 4916, and the radiopaque nose cone 28 are monitored and compared to determine, for example, when the frame 1500 is properly expanded and deployed at the desired position, indicating the degree of deployment of the frame 1500. For example, until the radiopaque marker 1580 within the valve seat 18 of the frame 1500 is substantially aligned with one or more radiopaque markers 4920 of the outer tube 4910, the marker 4920 on the distal side of the outer tube can be positioned substantially at the desired deployment position of the waist of the frame, and the docking station frame 1500 can be deployed from the delivery catheter assembly (such as by withdrawing the outer tube 4910). Thereby, the waist of the frame indicated by the marker 1580 is positioned at the desired deployment position. In the illustrated example, by this alignment, the frame 1500 is deployed about half or 50% from the outer tube 4910. At such a point, the operator can determine whether the frame 1500 is deployed at the proper position and continue the deployment of the frame 1500, or recapture the frame 1500 within the outer tube 4910, reposition it, and redeploy it from the outer tube 4910.

[0242] As shown in FIG. 96B, the outer tube 4910 (not shown under fluoroscopy) can be withdrawn until one or more radiopaque markers 4920 are substantially aligned with one of the radiopaque markers 4922 of the connection tube 4916. The radiopaque marker 1580 of the frame 1500 can be disposed between the nose cone 28 and the radiopaque marker 4920 of the outer tube 4910, and the frame 1500 can be deployed more than half. 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 vasculature. The alignment of the radiopaque marker 4920 of the outer tube 4910 and the radiopaque marker 4922 of the connection tube 4916 can provide an indication to the operator regarding the amount of the frame 1500 that is deployed. The alignment of the radiopaque marker 4920 of the outer tube 4910 and the radiopaque marker 4922 of the connection tube 4916 can provide an indication of the desired amount 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, the alignment of the radiopaque marker 4920 of the outer tube 4910 and the radiopaque marker 4922 of the connection tube 4916 can indicate that the frame 1500 is 50% - 75% deployed, such as 60% deployed. In addition or alternatively, the alignment of one of the radiopaque markers 4920 of the outer tube 4910 and one of the radiopaque markers 4922 of the connection tube 4916 can indicate when the frame 1500 is fully deployed from the outer tube 4910, except that the elongated leg 5000 is attached to the docking station connector 4914, and / or the desired position at which the frame 1500 should be released from the delivery catheter assembly.

[0243] 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 the deployment of the frame 1500. However, the outer tube 4910, the connecting tube 4916, the frame 1500, and / or any other optional components of the delivery system can have any suitable configuration of radiopaque or increased radiation density portions that can provide an indication regarding the amount of expansion or deployment of the frame 1500 prior to its release. For example, the frame 1500 can include a radiopaque marker 1580 at the junction 1503 on the distal side of the valve seat 18, which, when aligned with the radiopaque marker 4920 of the catheter 3600 during deployment of the frame 1500, indicates the desired or maximum amount of expansion and / or deployment of the frame 1500 prior to its release from the catheter 3600.

[0244] The foregoing has mainly described embodiments of a self-expanding docking station. However, the docking stations and / or delivery devices illustrated and described herein can be modified for delivery of balloon-expandable and / or mechanically-expandable docking devices within the scope of the present disclosure. That is, delivery of balloon-expandable and / or mechanically-expandable docking stations to their implantation sites can be performed percutaneously using a modified version of the delivery device of the present disclosure. In general terms, this includes providing a transcatheter assembly that can include a delivery sheath and / or additional sheaths 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 guide wire. The delivery catheter used in a balloon-expandable delivery device can define a lumen in which the balloon catheter is received. The balloon catheter then defines a lumen in which the guide wire is slidably disposed. Further, 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 operated to inflate the balloon, thereby transitioning the docking station to an expanded configuration.

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

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

[0247] (Example 2) The docking station according to any one of the embodiments herein, particularly the docking station of Example 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 according to any one of the embodiments herein, particularly the docking stations of Examples 1-2, wherein the plurality of radiopaque markers are attached to the opaque material.

[0249] (Example 4) The docking station according to any one of the embodiments herein, particularly the docking stations of Examples 1-3, wherein the radiopaque markers are each disposed within a pocket of the opaque material.

[0250] (Example 5) The docking station according to any one of the embodiments herein, particularly the docking stations of Examples 1-4, wherein the radiopaque markers each include an aperture extending through a central portion of the radiopaque marker.

[0251] (Example 6) The docking station according to any one of the embodiments herein, particularly the docking station of Example 5, wherein the radiopaque markers are attached to the opaque member through the apertures.

[0252] (Example 7) The docking station according to any one of the embodiments herein, particularly the docking stations of Examples 1-6, wherein the radiopaque markers indicate the deployment positions of transcatheter heart valves.

[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 of the embodiments herein, particularly embodiments 1-8, wherein the frame further includes a plurality of outflow cells.

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

[0256] (Example 11) The docking station of any of the embodiments 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 of the embodiments herein, particularly embodiments 1-11, wherein the radiopaque marker is attached to a plurality of joints of the frame.

[0258] (Example 13) A docking station for a medical device, comprising a proximal end and a distal end, a valve seat, and a plurality of stages of a 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 vertices at the proximal end and the distal end, a plurality of stages, and a plurality of eyelets at at least one vertex of the proximal end and the distal end, a frame, and an impermeable material attached to the frame.

[0259] (Example 14) The docking station of any of the embodiments 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 includes four stages of compression members.

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

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

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

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

[0265] (Example 20) 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 a plurality of vertices at the proximal end and the distal end, an impermeable material having a proximal portion with a first edge, a distal portion with 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 valve seat station.

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

[0267] (Example 22) A docking station according to any embodiment herein, particularly embodiments 20-21, further comprising a plurality of radiopaque markers, each radiopaque marker disposed within a pocket of an opaque member.

[0268] (Example 23) A docking station according to any embodiment herein, particularly embodiments 20-22, wherein the opaque 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, a distal end, a valve seat, a plurality of stages of a compression member 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 opaque material attached to the frame, wherein at least a portion of the outflow cells is not covered by the opaque material so that blood can flow through the outflow cells.

[0270] (Example 25) A docking station according to any embodiment herein, particularly embodiment 24, wherein the outflow cells form a part of the permeable portion of the docking station.

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

[0272] (Example 27) A docking station according to any embodiment herein, particularly embodiments 24-26, wherein the cell closest to the distal end includes an outlet.

[0273] (Example 28) A docking station according to any embodiment herein, particularly embodiments 24-27, wherein each outflow cell is partially defined by an outflow compression member.

[0274] (Example 29) A docking station according to any of the embodiments herein, particularly the docking stations of Examples 24-28, wherein each effluent cell includes 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 a compression material 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 material within the valve seat is thicker than the other compression materials within the frame.

[0276] (Example 31) A docking station according to any of the embodiments herein, particularly the docking station of Example 30, wherein the impermeable material includes a non-elastic waistband.

[0277] (Example 32) A docking station according to any of the embodiments herein, particularly the docking stations of Examples 30-31, further comprising a plurality of radiopaque markers disposed within the valve seat.

[0278] (Example 33) A docking station according to any of the embodiments herein, particularly the docking stations of Examples 30-32, further comprising a plurality of vertices at the proximal end and the distal end.

[0279] (Example 34) A docking station according to any of the embodiments herein, particularly the docking station of Example 33, further comprising a plurality of eyelets near the vertex 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 stages of a compression material extending from the proximal end to the distal end and defining a plurality of cells, a plurality of vertices at the proximal end and the distal end, and an impermeable material, wherein a portion of the cells near the distal end is not covered by the impermeable material.

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

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

[0283] (Example 38) The docking station of any of the embodiments herein, particularly the docking stations of Examples 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 the docking stations of Examples 35 - 38, wherein when the docking station is deployed, blood can flow between the impermeable material and the compression 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 a compression material extending from the proximal end to the distal end and defining a plurality of cells, a plurality of vertices 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 coating on which it is deposited.

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

[0287] (Example 42) The docking station of any of the embodiments 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) A medical device comprising a frame having a proximal end, a distal end, a valve seat, and a plurality of stages of a compression member extending from the proximal end to the distal end and defining a plurality of cells, a plurality of pockets circumferentially disposed around the opaque member, and radiopaque markers disposed within each pocket, wherein when the opaque member is attached to the frame, the pockets are disposed within the valve seat.

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

[0291] (Example 46) The medical device of any of the embodiments herein, particularly embodiment 45, wherein the pockets extend radially outward from the remainder of the opaque member.

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

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

[0294] (Example 49) The medical device of any of the embodiments herein, particularly embodiment 48, wherein the pocket covering is secured to the remainder of the radiopaque member by stitches extending through one of the apertures of the radiopaque 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, wherein the position of the one or more radiopaque markers of the docking station relative to the radiopaque markers of the tube indicates the 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 of the embodiments 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 disposed around the valve seat of the docking station frame.

[0300] (Example 55) The alignment of one of the X-ray impermeable markers of the tube and the X-ray impermeable marker of the docking station frame, in any of the embodiments herein, particularly the systems of embodiments 50-54, indicating the amount of deployment of the docking station frame.

[0301] (Example 56) Positioning the X-ray impermeable marker of the docking station frame at a target position for deploying the valve seat of the docking station frame, deploying a portion of the docking station frame from the tube such that the X-ray impermeable marker of the tube is substantially aligned with the X-ray impermeable marker of the docking station frame, visually verifying that the X-ray impermeable marker of the tube and the X-ray impermeable marker of the docking station frame are at the target position, and further deploying and releasing the docking station frame from the tube, a method of deploying a docking station frame.

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

[0303] (Example 58) The position of the X-ray impermeable marker of the docking station relative to the X-ray impermeable marker of the tube, in any of the embodiments herein, particularly the methods of embodiments 56-57, indicating the amount of deployment of the docking station from the tube.

[0304] (Example 59) The method of any of the embodiments herein, particularly the methods of 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 examples herein, particularly the methods of Examples 56 to 59, wherein the docking station frame includes a plurality of radiopaque markers disposed around the valve seat of the docking station frame.

[0306] (Example 61) 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 connection tube having one or more radiopaque markers disposed within the outer tube, and a docking station frame disposed within the outer tube and connected to the connection tube, wherein the docking station frame is deployed by retracting the outer tube proximally relative to the connection tube, and the position of the one or more radiopaque markers of the connection tube relative to the one or more radiopaque markers of the outer tube indicates the amount of deployment of the docking station from the outer tube.

[0307] (Example 62) The system of any of the examples herein, particularly the system of Example 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 examples herein, particularly the systems of Examples 61 to 62, wherein the frame includes a plurality of radiopaque markers disposed around the valve seat.

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

[0310] (Example 65) The system of any of the examples herein, particularly the systems of Examples 61 to 64, wherein the connection tube includes a plurality of radiopaque markers disposed along the length of the connection tube.

[0311] (Example 66) Alignment of one or more of the radiopaque markers of the outer tube and one or more of the radiopaque markers of the connecting tube indicates the amount of deployment of the frame, of any of the examples herein, particularly the systems of Examples 61 - 65.

[0312] (Example 67) Alignment of one or more of the radiopaque markers of the outer tube and one or more of the radiopaque markers of the connecting tube indicates the release point of the frame, of any of the examples herein, particularly the systems of Examples 61 - 66.

[0313] (Example 68) 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, the frame is configured to be recaptured by the outer tube, of any of the examples herein, particularly the systems of Examples 61 - 67.

[0314] (Example 69) A method of deploying a docking station frame, including deploying a portion of the docking station frame from the outer tube together with the connecting tube such that the radiopaque marker of the outer tube approaches the radiopaque marker of the connecting tube, and a substantial alignment of the radiopaque marker of the outer tube and the radiopaque marker of the connecting tube indicates the final point at which the docking station frame is capturable by the outer tube.

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

[0316] (Example 71) The method of any of the embodiments herein, particularly the methods of 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 the methods of 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 the methods of 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 the methods of embodiments 69-73, wherein the docking station frame includes a plurality of radiopaque markers disposed around the valve seat of the docking station frame.

[0320] (Example 75) A delivery catheter assembly comprising: an elongate nose cone; 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 connection tube disposed within the outer tube and including one or more radiopaque markers disposed between the elongate nose cone 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 one or more radiopaque markers, the docking station frame being deployed by retracting the outer tube proximally from the elongate nose cone, the radiopaque markers of the outer tube, the radiopaque markers of the connection tube, and the radiopaque markers of the docking station frame being configured to visually identify a proper placement of the docking station frame and a final location where the docking station frame is recapturable by the outer tube.

[0321] (Example 76) The system of any of the embodiments herein, particularly the system of Example 75, wherein 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 the systems of Examples 75-76, wherein the frame includes a plurality of radiopaque markers disposed around a valve seat.

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

[0324] (Example 79) One or more radiopaque markers of the outer tube and the alignment of one or more of the radiopaque markers of the connecting tube indicate the amount of deployment of the frame, in any of the embodiments herein, particularly the systems of embodiments 75-78.

[0325] (Example 80) One or more radiopaque markers of the outer tube and the alignment of one or more of the radiopaque markers of the connecting tube indicate the release point of the frame, in any of the embodiments herein, particularly the systems of embodiments 75-79.

[0326] (Example 81) 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, the frame is configured to be recaptured by the outer tube, in any of the embodiments herein, particularly the systems of embodiments 75-80.

[0327] (Example 82) A frame having a valve seat and a plurality of radiopaque markers disposed around the valve seat, an elongated nose cone at the 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 nose cone and the docking station connector, wherein the frame is deployed by retracting the outer tube proximally from the elongated nose cone.

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

[0329] (Example 84) Alignment of one or more radiopaque markers of the outer tube with one of the radiopaque markers of the frame or the radiopaque marker of the connecting tube, an assembly of any of the embodiments herein, particularly the assemblies of Examples 82 - 83, indicating the amount of deployment of the frame.

[0330] (Example 85) An assembly of any of the embodiments herein, particularly the assemblies of Examples 82 - 84, where the indicated amount of deployment is the maximum amount deployed before the frame is recaptured by the outer tube.

[0331] (Example 86) An assembly of any of the embodiments herein, particularly the assemblies of Examples 82 - 85, where the radiopaque marker of the frame indicates the deployment position of the transcatheter valve.

[0332] (Example 87) An assembly of any of the embodiments herein, particularly the assemblies of Examples 82 - 86, where 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, defining a plurality of cells and valve seats, an impermeable material attached to the frame, and radiopaque sutures disposed around the impermeable material.

[0334] (Example 89) A docking station of any of the embodiments herein, particularly the docking station of Example 88, where the radiopaque sutures are disposed around the valve seat.

[0335] (Example 90) A docking station of any of the embodiments herein, particularly the docking stations of Examples 88 - 89, where the radiopaque sutures are at least partially disposed around one of the plurality of compression members of the frame.

[0336] (Example 91) The docking station of any example of this specification, particularly examples 88 to 90, where the radiopaque suture indicates the deployment position of the transcatheter heart valve.

[0337] (Example 92) The docking station of any example of this specification, particularly examples 88 to 91, which further includes a plurality of radiopaque markers.

[0338] (Example 93) The docking station of any example of this specification, particularly example 92, where the radiopaque marker is attached to the frame.

[0339] Considering many possible embodiments to which the principles of the disclosed invention may be applied, it should be recognized that the illustrated embodiments are only preferred examples of the invention and should not be understood as limiting the scope of the invention. All combinations or sub - combinations of the features of the above - mentioned exemplary embodiments are contemplated by this application. The scope of the invention is defined by the following claims. Accordingly, all that falls within the scope and spirit of these claims is claimed as the inventors' invention.

Explanation of Reference Numerals

[0340] 10 Docking station 12 Proximal end 14 Distal end 18 Valve seat 20 Band 21 Impermeable material 29 Valve 194 Stabilizing bar 210 Region 212 Region 410 Sealing portion 414 Fixing portion 416 Inner surface 510 Outer surface 512 Inner surface 602 Direction of blood flow, arrow 608 Space, blood 710 Radially outward force 712 Frame 720 Radially outward force 722 Radially outward force 750 Curve 752 Region 754 Region 760 Pulmonary artery branch 900 Arrow 912 Solid region 1100 Arrow 1102 First half-piece 1104 Second half-piece 1106 Distal end 1108 Proximal end 1110 Distal end 1400 Permeable part 1402 Permeable part 1404 Impermeable part 1420 Region 1500 Frame 1502 Metal compression member 1504 Cell 1510 End, vertex 2000 Part 2020 Arrow 2100 Region 2130 Region 2132 Arrow 2300 Vessel 2302 Vessel 2700 Frame 2716 Narrow part 3132 Arrow 3202 Arrow 3208 Space 3400 Arrow 3512 Solid region 3600 Catheter 4500 Tricuspid valve 4910 Outer tube, sleeve 4912 Inner tube, sleeve 4914 Docking station connector 4916 Connecting tube 5000 Extension, elongated leg 5002 Guide wire 5110 Distal end 5112 Base portion, proximal end 5200 Inner cavity 5308 Inclination 5310 Shelf portion 5500 Adhesive portion 5600 Inner surface 5636 Head 5638 Straight portion 5640 Side surface 5702 Point 5704 Point 5710 Concave portion 5800 Handle 5810 Housing 5812 Driving member 5814 Driven member 5816 Arrow 5818 Arrow 5820 Concave portion 5822 Protrusion 5830 Engagement portion 5840 Linear concave portion 5842 Linear protrusion 5850 Female thread 5852 Male thread 5860 Concave portion 5862 Luer port 6000 Arrow 6002 Arrow 6200 Handle 6210 Housing 6212 Driving member 6214 Driven member 6216 Arrow 6218 Arrow 6230 Engagement portion 6240 Protrusion 6242 Concave portion, linear groove 6250 Pinion gear 6252 Rack gear portion 6348 Gap, space 6354 Aperture 6360 Arrow 6370 Arrow 6390 Opening 6800 Ratchet mechanism 6810 Protrusion 6812 Stop surface 6814 Inclined surface 6822 Axle 6850 Withdrawal direction 6852 Forward direction 6870 Side surface 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 catheter having a proximal end and a distal end, A valve seat; a frame comprising: a plurality of sections of struts extending from the proximal end to the distal end and defining a plurality of cells; a plurality of pockets circumferentially disposed about the impermeable member; an opaque member comprising a radiopaque marker disposed within each of the pockets; The medical device, wherein the pocket is disposed within the valve seat when the impermeable member is attached to the frame.

2. A medical device as described in claim 1, wherein the pocket is rectangular.

3. A medical device as described in claim 2, wherein the pocket extends radially outward from the remainder of the impermeable member.

4. Further comprising a plurality of pocket coverings, The medical device of claim 2 , wherein one of the pocket coverings covers each of the pockets.

5. A medical device as described in claim 4, wherein each of the pocket coverings is secured to the remainder of the opaque member by a stitch extending through an aperture in one of the radiopaque markers.

6. A medical device as described in any one of claims 1 to 5, wherein each of the radiopaque markers has an aperture extending through a central portion of the radiopaque marker.

7. A tube having one or more radiopaque markers; a docking station frame disposed within the tube; the docking station includes one or more radiopaque markers; A system wherein a position of one or more radiopaque markers on the docking station relative to the radiopaque markers on the tube indicates an amount of deployment of the docking station from the tube.

8. The system described in claim 7, wherein the radiopaque marker of the tube is disposed at or near the distal end of the tube.

9. The system described in claim 7, wherein the docking station frame is deployed by retracting the tube proximally relative to the docking station.

10. A system described in any one of claims 7 or 9, wherein the one or more radiopaque markers of the tube are radiopaque bands embedded in the tube.

11. A system described in any one of claims 7 to 10, wherein the docking station frame includes a plurality of radiopaque markers arranged around the valve seat of the docking station frame.

12. A system described in any one of claims 7 to 11, wherein alignment of one of the radiopaque markers on the tube and the radiopaque marker on the docking station frame indicates the amount of deployment of the docking station frame.

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