Expandable docking station frame and system

Abstract

To provide docking stations / stents, delivery systems and methods for use in implanting a heart valve.SOLUTION: Expandable docking stations for docking an expandable valve can include a valve seat, one or more sealing portions, and one or more retaining portions. The valve seat can be unexpandable or substantially unexpandable beyond a deployed size. The one or more sealing portions are connected to the valve seat and extend radially outward of the valve seat. The one or more sealing portions are constructed to expand outward of the valve seat and provide a seal over a range of sizes. The one or more retaining portions are connected to the one or more sealing portions. The one or more retaining portions are configured to retain the docking station at a deployed position.SELECTED DRAWING: Figure 22

Description

Technical Field

[0004] ,

[0001] The present invention 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

[0002] 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 may 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.

[0003] Transcatheter techniques can also be used to introduce and implant an artificial heart valve using a flexible catheter in a less invasive manner than open heart surgery. In this technique, the artificial valve can be attached to the end portion of the flexible catheter in a folded state and advanced through the patient'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, such as by inflating a balloon carrying the valve. Alternatively, the valve can have an elastic self-expanding stent or frame that expands to its functional size when the valve is advanced from a delivery sheath at the distal end of the catheter.

[0004] Transcatheter heart valves (THVs) can be appropriately sized to fit inside most natural aortic valves. However, if the natural valve, blood vessel, and graft are large, the transaortic catheter valve may be too small to fit securely into the large implantation or deployment site. In this case, the catheter valve may not be large enough to expand sufficiently inside the natural valve or other implantation or deployment site to be secured in place.

[0005] The replacement of the pulmonary valve, sometimes referred to as the pulmonic valve, presents significant challenges. The geometry of the pulmonary artery can vary considerably from patient to patient. Generally, the pulmonary outflow tract after corrective surgery is too wide to effectively position an artificial heart valve. [Prior art documents] [Patent Documents]

[0006] [Patent Document 1] U.S. Patent No. 8,002,825 [Patent Document 2] International Patent Application Publication No. WO2000 / 42950 [Patent Document 3] U.S. Patent No. 5,928,281 [Patent Document 4] U.S. Patent No. 6,558,418 [Patent Document 5] U.S. Patent No. 6,540,782 [Patent Document 6] U.S. Patent No. 3,365,728 [Patent Document 7] U.S. Patent No. 3,824,629 [Patent Document 8] U.S. Patent No. 5,814,099 [Overview of the Initiative] [Means for solving the problem]

[0007] This summary is for illustrative purposes only and is not intended to limit the scope of the invention in any way. For example, any feature included in the examples in this summary is not essential to the claims unless that feature is explicitly enumerated in the claims. This specification discloses exemplary embodiments of an expandable docking station for an expandable valve, a catheter for an expandable docking station, and a handle for a catheter. The docking station, catheter, and handle can be constructed in a variety of ways.

[0008] In one embodiment, for example, the docking station may include a valve seat, one or more sealing portions, and one or more retaining portions. In one embodiment, the valve seat may be substantially immobile beyond its deployed size, i.e., the diameter of the valve seat may only increase by a maximum of 0 to 4 mm. One or more sealing portions may connect to the valve seat and extend radially outward from the valve seat. One or more sealing portions may be constructed to expand and extend outward from the valve seat to provide a seal over a certain size range (for example, over a certain expanded size range and / or over a certain size range within the circulatory or vascular system, when expanded in blood vessels or locations of different shapes and sizes). One or more retaining portions may connect to one or more sealing portions. One or more retaining portions may be configured to retain the docking station in the deployed position. The expandable docking station may expand and provide a seal over a range of 27 mm to 38 mm. The expandable docking station may expand radially outward to varying degrees along its length L. The valve seat and one or more sealing portions can act as isolators, reducing or preventing the radially outward force of the expanding valve at the valve seat from being transferred to one or more sealing portions or one or more retaining portions. The docking station can be configured such that the retention by the retaining portions is reinforced by blood pressure. One or more retaining portions can be configured such that the force applied by at least one of the one or more retaining portions in the deployed position is proportional to the blood pressure acting on the docking station. One or more retaining portions can be configured such that the force applied by at least one of the one or more retaining portions is greater when the heart is in diastole than when the heart is in systole. The valve seat can be formed by sutures, rings, bands, structural components, materials, foams, and other methods. The sealing portions can include a portion of a metal frame covered with fabric, polymer, and / or other materials. The sealing portions can include open-cell foam.A portion of the docking station may be permeable to blood, and a portion of the docking station may be impermeable to blood. The impermeable portion of the docking station may extend at least from the valve seat to at least the sealing portion. The docking station may be length-adjustable. The docking station may include a first half into which a second half of the docking station may extend in an adjustable manner to adjust its length. One or more restraining portions may extend radially outward from one or more sealing portions when the docking station is in an unrestrained state. Other features described elsewhere in this disclosure may also be included.

[0009] In an exemplary embodiment, the system may include an expandable docking station and an expandable valve. The expandable docking station may include a valve seat, one or more sealing portions, and one or more retaining portions. The valve seat may expand to a deployed size. One or more sealing portions may be connected to the valve seat and may extend radially outward from the valve seat, and may be constructed to provide a seal over a certain expanded size range. One or more retaining portions may be connected to one or more sealing portions. One or more retaining portions may be configured to hold the docking station in place in the deployed position. The expandable valve may include an expandable frame and valve elements. The expandable frame may be expanded to engage with the valve seat of the docking station. The valve elements may be connected to the expandable frame. Expandable docking stations and expandable valves can be configured such that, when embedded in a portion of a circulating system, the radially outward force applied by the sealing portion to that portion of the circulating system is less than half (and may be less than 1 / 3, less than 1 / 4, less than 1 / 8, or less than 1 / 10) of the radially outward force applied to the valve seat by the expandable frame, provided the sealing portion is within a certain size range. Expandable docking stations can be configured such that, when embedded in a portion of a circulating system, the diameter of the valve seat does not increase by more than 3 mm (or more than 1 mm, 2 mm, or 4 mm) due to the radially outward force applied to the valve seat by the expandable frame. The size range of the sealing portion can be 27 mm to 38 mm. Expandable docking stations can be configured to expand radially outward to varying degrees along their length L when embedded in a portion of a circulating system.

[0010] An expandable docking station can be configured such that, when implanted in a portion of the circulatory system, the retention provided by the retention portion is enhanced by the blood pressure acting on the expandable docking station. The expandable docking station can be configured such that, when implanted in a portion of the circulatory system, the force applied by the retention portion is proportional to the blood pressure acting on the assembly. The expandable docking station can be configured such that, when implanted in a portion of the circulatory system, the force applied by the retention portion is greater when the heart is in diastole than when the heart is in systole. The valve seat can be formed by sutures, rings, bands, structural components, materials, foam, and other means. The sealing portion can include a portion of a fabric-covered metal frame. The sealing portion can include open-cell foam. Parts of the docking station can be permeable to blood, and parts of the docking station can be impermeable to blood. The impermeable portion of the docking station can extend at least from the valve seat to at least the sealing portion. The docking station can have an adjustable overall length. The docking station may include a first half (i.e., a portion) into which a second half (i.e., a portion) of the docking station may be adjustable to adjust the overall length. In other words, the length of the docking station can be adjusted by moving the second half / part relative to the first half / part, and the first half / part may be moved independently of the second half / part (for example, one half / part may remain in place while the other half / part moves). If one of the first or second half / part extends within the other half / part and overlaps to adjust the length, the first and second half / parts may be adjusted to change the amount / length of their overlap. One or more restraining portions may extend radially outward from one or more sealing portions when the docking station is unrestrained. Other features described elsewhere in this disclosure may also be included.

[0011] In one exemplary embodiment, the method may include expanding a docking station and expanding a valve within the docking station. The docking station may be expanded such that the valve seat of the docking station expands to the size after deployment of the valve seat, and the sealing portion expands to a sealing size within a certain sealing size range. The frame of an expandable valve may be expanded to engage the valve seat of the docking station. The radially outward force applied by the sealing portion over the sealing size range may be less than half (and also less than 1 / 3, 1 / 4, 1 / 8, or 1 / 10) of the radially outward force applied to the valve seat by the frame after the expandable frame has been expanded. The valve seat of the docking station may be configured such that the diameter of the valve seat does not increase by more than 2 mm (or more than 1 mm, 3 mm, or 4 mm) due to the radially outward force applied to the valve seat by the expandable frame. The sealing size range of the docking station may be 27 mm to 38 mm. The valve seat can be formed by sutures, rings, bands, structural components, materials, foams, and other means. Other features / steps described elsewhere in this disclosure may also be included.

[0012] In an exemplary embodiment, the system may include an expandable docking station and an expandable valve. The expandable docking station may include a valve seat, one or more sealing portions, and one or more retaining portions. The valve seat may expand to its deployed size. One or more sealing portions may connect to the valve seat and extend radially outward from the valve seat. One or more sealing portions may extend outward from the valve seat and be constructed to provide a seal over a certain size range. One or more retaining portions may connect to one or more sealing portions. One or more retaining portions may be configured to retain the docking station in the deployed position. The expandable valve may comprise an expandable frame and valve elements. The expandable frame may expand to engage with the valve seat of the docking station. The valve elements may connect to the expandable frame. The blood pressure acting on the valve and docking station may enhance the retention by the retaining portions in the deployed position.

[0013] The valve seat can be configured such that it is not substantially expanded radially outward by the radially outward force of the expandable valve. The size range of the sealing portion can be 27 mm to 38 mm. The docking station can be configured to expand radially outward to varying degrees along its length L. The force applied by the retaining portion can be proportional to the blood pressure acting on the assembly. The force applied by the retaining portion may be greater when the heart is in diastole than when the heart is in systole. The valve seat can be formed by sutures, rings, bands, structural components, materials, foam, and other methods. The sealing portion may include a portion of a metal frame covered with fabric. The sealing portion may include open-cell foam or other materials. Part of the docking station may be permeable to blood, and part of the docking station may be impermeable to blood. The impermeable portion of the docking station may extend at least from the valve seat to at least the sealing portion. The docking station may be length adjustable. The docking station may include a first half (i.e., a portion) into which a second half (i.e., a portion) of the docking station may be adjustable to adjust the overall length. In other words, the length of the docking station can be adjusted by moving the second half / part relative to the first half / part, and the first half / part may be moved independently of the second half / part (for example, one half / part may remain in place while the other half / part moves). If one of the first or second half / part extends within the other half / part and overlaps to adjust the length, the first and second half / parts may be adjusted to change the amount / length of their overlap. One or more restraining portions may extend radially outward from one or more sealing portions when the docking station is unrestrained. Other features described elsewhere in this disclosure may also be included.

[0014] In one exemplary embodiment, the method may include the steps of expanding a docking station and expanding a valve within the docking station. The docking station may be expanded such that the valve seat of the docking station expands to the size of the valve seat after deployment, and the sealing portion expands to a sealing size within a certain sealing size range. The frame of the expandable valve may be expanded to engage the valve seat of the docking station. The blood pressure acting on the valve and docking station can enhance the retention by the retaining portion in the deployed position. The valve seat of the docking station may be configured such that the diameter of the valve seat does not increase by more than 2 mm (or more than 1 mm, 3 mm, or 4 mm) due to the radially outward force applied to the valve seat by the expandable frame. The sealing size range of the docking station may be 27 mm to 38 mm. The valve seat may be formed by sutures, rings, bands, structural components, materials, foams, and other methods. Other features / steps described elsewhere in this disclosure may also be included.

[0015] In one embodiment, for example, the docking station may include a valve seat and one or more sealing portions. The valve seat may be expandable to a size after deployment. One or more sealing portions may connect to the valve seat and extend radially outward from the valve seat. One or more sealing portions may extend outward from the valve seat and be constructed to provide a seal over a certain size range. The length of the docking station may be adjustable. The docking station may include a first half (i.e., portion) into which a second half (i.e., portion) of the docking station may be adjustable to adjust the overall length. In other words, the length of the docking station can be adjusted by moving the second half / part relative to the first half / part, and the first half / part may be moved independently of the second half / part (for example, one half / part may remain in place while the other half / part moves). If one of the first or second half / part extends within the other half / part and overlaps to adjust its length, the first half / part and the second half / part may be adjusted to change the amount / length of their overlap.

[0016] The valve seat can be constructed such that it is not substantially expandable radially outward by the radially outward force of the expanding valve. The size range of the sealing portion can be 27 mm to 38 mm. The docking station can be configured to expand radially outward to varying degrees along its length L. The valve seat and one or more sealing portions can act as isolators that substantially prevent the radially outward force of the expanding valve from being transferred to one or more sealing portions. The valve seat can be formed by sutures, rings, bands, structural components, materials, foams, and other means. The sealing portion may include a portion of a fabric-covered metal frame. The sealing portion may include open-cell foam. Part of the docking station may be permeable to blood, and part of the docking station may be impermeable to blood. Other features described elsewhere in this disclosure may also be included.

[0017] In one exemplary embodiment, the system may include an expandable docking station and an expandable valve. The expandable docking station may include a valve seat and one or more sealing portions. The valve seat may expand to a deployed size. One or more sealing portions may connect to the valve seat and extend radially outward from the valve seat. One or more sealing portions may extend outward from the valve seat and be constructed to provide a seal over a certain size range. The length of the docking station may be adjustable, for example, in the same or similar manner as considered elsewhere in this specification. The expandable valve may comprise an expandable frame and a valve element. The expandable frame may expand to engage with the valve seat of the docking station. The valve element may connect to the expandable frame. A second half of the docking station may extend into the first half of the docking station to make the length of the docking station adjustable. The valve seat may be configured such that the valve seat is not substantially expanded radially outward by the radially outward force of the expandable valve. The docking station may be configured to extend radially outward to varying degrees along its length L. The valve seat may be formed from sutures, rings, bands, structural components, materials, foam, and other means. The sealing portion may include a portion of a fabric-covered metal frame. The sealing portion may include open-cell foam. Part of the docking station may be blood-permeable, and part of the docking station may be blood-impermeable. Other features described elsewhere in this disclosure may also be included.

[0018] In one exemplary embodiment, the method may include the steps of expanding a multi-piece docking station and expanding a valve within the docking station. A first docking station half or portion may be expanded. A portion / section of a second docking station half or portion may be positioned within the first docking station half so that, for example, a desired length overlaps. The length of the docking station can be set by expanding the second docking station half within the first docking station half. The docking station may have a valve seat and a sealing portion. The frame of an expandable valve may be expanded to engage the valve seat of the docking station. The valve seat may be configured such that the valve seat is not substantially expanded radially outward by the radially outward force of the expandable valve. The predetermined size of the sealing portion of the docking station may be 27 mm to 38 mm. The valve seat may be formed by sutures, rings, bands, structural components, materials, foams, and other methods. Other features / steps described elsewhere in this disclosure may also be included.

[0019] In one exemplary embodiment, the delivery catheter may include an outer tube and an inner tube. The outer tube may have a distal opening. The inner tube may be disposed within the outer tube such that a gap is formed between the inner tube and the outer tube. The inner tube may have an opening at its proximal end and may have one or more side openings. The delivery catheter may be configured such that lavage fluid is injected into the proximal end of the inner tube, causing the lavage fluid to flow through the inner tube, with at least a portion of the lavage fluid exiting the inner tube through one or more side openings to fill the gap and expel air from the distal opening of the outer tube. The inner tube may have a distal opening, and the delivery catheter may be configured to expel air from the distal opening of the inner tube by filling the inner tube with lavage fluid at its proximal end. The inner tube may be filled with lavage fluid through an opening for a guidewire at the proximal end of the inner tube. The delivery catheter may be configured to expel air from within the inner tube through the distal opening of the inner tube and through an opening in a nose cone that can be connected to the inner tube. Other features described elsewhere in this disclosure may also be included.

[0020] In an exemplary embodiment, the method can expel air from the delivery catheter. The delivery catheter can include an outer tube having a distal opening, an inner tube having a proximal opening and one or more side openings at the proximal end of the inner tube, and a gap formed between the inner tube and the outer tube. The cleaning liquid can be injected into the proximal end of the inner tube such that the cleaning liquid flows through the inner tube, at least a portion of the cleaning liquid exits the inner tube through the one or more side openings to fill the gap, and expels air from the distal opening of the outer tube. The inner tube can be filled with the cleaning liquid through the proximal opening, and the proximal opening can also be used to pass a guide wire through the delivery catheter. After expelling the air, the delivery catheter can be inserted into a blood vessel. Other features / steps described elsewhere in this disclosure may also be included.

[0021] In an exemplary embodiment, a catheter and docking station, a sleeve, a docking station retainer, and a docking station. The docking station retainer can be disposed within the sleeve. The docking station retainer may include one or more retainer recesses. The docking station can be disposed within the sleeve. The docking station may include one or more extensions that are releasably attached to the docking station retainer. Each of the one or more extensions may include a head disposed in at least one of the one or more retainer recesses. Each of the one or more docking extensions may be configured to contact the docking station retainer at only two points. The head may be triangular and may include two heads. The one or more retainer recesses may be rectangular recesses of the docking station retainer. The sides of the heads may extend away from each other at angles from 60 to 120 degrees. The sleeve can engage one or more extensions to retain one or more heads within the retainer recesses when the sleeve is positioned over one or more extensions. When the restraint by the sleeve is released, one or more extensions can spring radially outward relative to the docking station retainer, thereby freeing one or more extensions from the docking station retainer. One or more extensions can be tilted within one or more recesses. Other features described elsewhere in this disclosure may also be included.

[0022] In one exemplary embodiment, a method of using a docking station may include the step of positioning the head of the docking station extension within a recess of the docking station retainer such that the docking station extension contacts the docking station retainer at only two points. The docking station and docking station retainer may be housed in a sleeve. The sleeve can engage with the docking station extension to retain the head of the docking station extension within the recess. The head may be triangular. The recess may be a rectangular recess in the docking station retainer. The sides of the head may extend away from each other at angles from 60 to 120 degrees. The retainer and docking station may be removed from the sleeve such that the head of the docking station extension springs radially outward relative to the docking station retainer, releasing the docking station extension from the docking station retainer. The extension may be tilted within the recess. Other features / steps described elsewhere in this disclosure may also be included.

[0023] In an exemplary embodiment, an assembly that deploys a docking station includes a handle and a catheter. The handle can include a housing, a drive member, and a passive member. The drive member can be rotatably coupled to the housing. The passive member can be coupled to the drive member and the housing such that rotation of the drive member causes the passive member to linearly move within the housing. The catheter can include an outer sleeve and an inner sleeve. The outer sleeve can be fixedly connected to the passive member. The inner sleeve can be disposed within the outer sleeve and fixedly connected to the housing. Rotation of the drive member can move the outer sleeve relative to the inner sleeve. The drive member can include a wheel having a gear portion. The drive member can include a female threaded member. The passive member can include a rack gear. The passive member can include a male threaded member. A ratchet mechanism can be movable from an engaged position to a disengaged position such that when the ratchet is in the engaged position, the drive member can be rotated in only one direction. A luer port may be fixed to the inner sleeve. The luer port and the inner sleeve can be configured to receive a guide wire that extends through an inner shaft. Other features described elsewhere in this disclosure may also be included.

[0024] In an exemplary embodiment, a method of deploying a docking station can include rotating a drive member relative to a housing to linearly move a passive member within the housing. The inner sleeve can be fixed to the housing and the outer sleeve can be fixed to the passive member. Rotation of the drive member moves the outer sleeve relative to the inner sleeve. The drive member can linearly move the passive member by engagement of gear teeth. The drive member can linearly move the passive member by engagement of threads. The drive member can be configured to rotate in only one direction. The first and second sleeves can be moved beyond a guide wire.

[0025] Various features, such as those described in any part of this disclosure, may be included in the examples outlined herein, and various methods and steps for using the examples and features, including those described in any part of this specification, may be used.

[0026] A further understanding of the nature and merits 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, similar parts have the same reference numerals.

[0027] To further clarify the various aspects of the embodiments of this disclosure, specific embodiments will be described in more detail by reference to various aspects of the accompanying drawings. It should be recognized that these drawings only depict typical embodiments of this disclosure and are therefore not intended to limit the scope of this disclosure. Furthermore, while some embodiments may be drawn to scale, not all embodiments may be drawn to scale. The embodiments of this disclosure will be described and explained with further specificities and details using the accompanying drawings. [Brief explanation of the drawing]

[0028] [Figure 1A] This is a notch diagram showing a human heart in diastole. [Figure 1B] This is a notch diagram showing the human heart during systole. [Figure 2A] This is a cross-section of the pulmonary artery, showing that it can have a variety of different shapes and sizes. [Figure 2B] This is a cross-section of the pulmonary artery, showing that it can have a variety of different shapes and sizes. [Figure 2C] This is a cross-section of the pulmonary artery, showing that it can have a variety of different shapes and sizes. [Figure 2D] This is a cross-section of the pulmonary artery, showing that it can have a variety of different shapes and sizes. [Figure 2E] This is a cross-section of the pulmonary artery, showing that it can have a variety of different shapes and sizes. [Figure 3A] This is a perspective view of the pulmonary artery, showing that it can have a variety of different shapes and sizes. [Figure 3B] This is a perspective view of the pulmonary artery, showing that it can have a variety of different shapes and sizes. [Figure 3C] This is a perspective view of the pulmonary artery, showing that it can have a variety of different shapes and sizes. [Figure 3D] This is a perspective view of the pulmonary artery, showing that it can have a variety of different shapes and sizes. [Figure 4A] This is a schematic diagram showing a compressed docking station located within the circulatory system. [Figure 4B] Figure 4A is a schematic diagram showing the docking station, which has been extended to define the location of the docking station within the circulatory system. [Figure 4C] Figure 4B is a schematic diagram showing an expandable transcatheter heart valve positioned within a docking station. [Figure 4D] This is a schematic diagram showing a transcatheter heart valve in Figure 4C, which is extended to position the heart valve within the docking station. [Figure 4E] This figure shows a docking station and a transcatheter heart valve deployed within an irregularly shaped section of the circulatory system. [Figure 4F] This diagram shows a docking station and transcatheter heart valve deployed within the pulmonary artery. [Figure 5A] This is a schematic diagram showing a compressed docking station located within the circulatory system. [Figure 5B] Figure 5A is a schematic diagram showing the docking station, which has been extended to define the location of the docking station within the circulatory system. [Figure 5C] Figure 5B is a schematic diagram showing an expandable transcatheter heart valve positioned within a docking station. [Figure 5D]This is a schematic diagram showing a transcatheter heart valve in Figure 5C, which is extended to position the heart valve within the docking station. [Figure 5E] This figure shows a docking station and a transcatheter heart valve deployed within an irregularly shaped section of the circulatory system. [Figure 5F] This diagram shows a docking station and transcatheter heart valve deployed within the pulmonary artery. [Figure 6A] This is a cross-section showing a human heart in systole with a docking station located within the pulmonary artery. [Figure 6B] This is a cross-section showing a systolic human heart with a docking station and transcatheter heart valve positioned in the pulmonary artery. [Figure 7A] Figure 6B is an enlarged schematic diagram showing the docking station and transcatheter heart valve when the heart is in systole. [Figure 7B] This is a view in the direction indicated by line 7B-7B in Figure 7A. [Figure 7C] This graph shows the relationship between the diameter of the docking station and the radially outward force applied by the docking station. [Figure 8] This is a cross-section showing a diastolic human heart with a docking station and a transcatheter heart valve deployed in the pulmonary artery. [Figure 9A] This is an enlarged schematic diagram showing the docking station and transcatheter heart valve in the diastolic state of the heart (Figure 8). [Figure 9B] This is a view of the direction indicated by the line 9B-9B in Figure 9A. [Figure 10A] This figure shows an exemplary embodiment of a docking station in which a transcatheter cardiac valve is located inside the docking station. [Figure 10B] This figure shows an exemplary embodiment of a docking station in which a transcatheter cardiac valve is located inside the docking station. [Figure 10C]This figure shows an exemplary embodiment of a docking station in which a transcatheter cardiac valve is located inside the docking station. [Figure 10D] This figure shows an exemplary embodiment of a docking station in which a transcatheter cardiac valve is located inside the docking station. [Figure 11A] This figure shows an exemplary embodiment of a nesting docking station. [Figure 11B] This figure shows an exemplary embodiment of a nesting docking station. [Figure 11C] This figure shows an exemplary embodiment of a nesting docking station. [Figure 11D] This figure shows an exemplary embodiment of a nesting docking station. [Figure 12A] This figure shows an exemplary embodiment of a docking station in which a transcatheter cardiac valve is located inside the docking station. [Figure 12B] This figure shows an exemplary embodiment of a docking station in which a transcatheter cardiac valve is located inside the docking station. [Figure 12C] This figure shows an exemplary embodiment of a docking station in which a transcatheter cardiac valve is located inside the docking station. [Figure 12D] This figure shows an exemplary embodiment of a docking station in which a transcatheter cardiac valve is located inside the docking station. [Figure 13A] This figure shows an exemplary embodiment of a nesting docking station. [Figure 13B] This figure shows an exemplary embodiment of a nesting docking station. [Figure 13C] This figure shows an exemplary embodiment of a nesting docking station. [Figure 13D] This figure shows an exemplary embodiment of a nesting docking station. [Figure 14A]This figure shows an exemplary embodiment of a docking station in which a transcatheter cardiac valve is located inside the docking station. [Figure 14B] This figure shows an exemplary embodiment of a docking station in which a transcatheter cardiac valve is located inside the docking station. [Figure 14C] This figure shows an exemplary embodiment of a docking station in which a transcatheter cardiac valve is located inside the docking station. [Figure 14D] This figure shows an exemplary embodiment of a docking station in which a transcatheter cardiac valve is located inside the docking station. [Figure 14E] This figure shows an exemplary embodiment of a docking station in which a transcatheter cardiac valve is located inside the docking station. [Figure 14F] This figure shows an exemplary embodiment of a docking station in which a transcatheter cardiac valve is located inside the docking station. [Figure 14G] This figure shows an exemplary embodiment of a docking station in which a transcatheter cardiac valve is located inside the docking station. [Figure 15A] This is a side view showing an exemplary embodiment of the frame of a docking station. [Figure 15B] This figure shows a cross-section of the frame shown in Figure 15A. [Figure 16] This figure shows the docking station frame of Figure 15A in a compressed state. [Figure 17A] Figure 15A is a perspective view showing the docking station frame. [Figure 17B] Figure 15A is a perspective view showing the docking station frame. [Figure 18] This is a perspective view showing an exemplary embodiment of a docking station having multiple covered cells and multiple open cells. [Figure 19]Figure 18 is a perspective view showing the docking station, with a portion cut out to show the transcatheter cardiac valve extended to its designated position within the docking station. [Figure 20] This figure shows a cross-section of the docking station, as shown in Figure 18, when it is implanted in a vascular system of the circulatory system. [Figure 21] Figure 18 shows a perspective view of the docking station when it is loaded into a vascular system of the circulatory system. [Figure 22] Figure 19 is a perspective view showing the docking station and valve when implanted in a vascular system of the circulatory system. [Figure 23A] This figure shows a cross-section of the docking station, as shown in Figure 18, when it is implanted in blood vessels of different sizes in the circulatory system. [Figure 23B] This figure shows a cross-section of the docking station, as shown in Figure 18, when it is implanted in blood vessels of different sizes in the circulatory system. [Figure 24] Figure 18 shows a cross-section of the docking stations when a schematic transcatheter heart valve of the same size is loaded or deployed into each docking station and implanted in a blood vessel of different sizes in the circulatory system. [Figure 25] Figure 18 shows a cross-section of the docking stations when a schematic transcatheter heart valve of the same size is loaded or deployed into each docking station and implanted in a blood vessel of different sizes in the circulatory system. [Figure 26A] This is a cross-sectional view showing an exemplary embodiment of a docking station located within the pulmonary artery. [Figure 26B] This is a cross-sectional view showing an exemplary embodiment of a docking station located in the pulmonary artery and a schematically shown valve located within the docking station. [Figure 26C]This is a cross-sectional view showing an exemplary embodiment of a docking station located in the pulmonary artery and a valve located within the docking station. [Figure 27] This is a side view showing an exemplary embodiment of a docking station. [Figure 28] This is a side view showing an exemplary embodiment of a nesting docking station. [Figure 29] Figure 28 is a side view showing the docking station, in which the two parts of the docking station are nested inside each other. [Figure 30] This is a cross-sectional view showing a docking station located within the pulmonary artery. [Figure 31A] This is a cross-sectional view showing an exemplary embodiment of a docking station located within the pulmonary artery. [Figure 31B] This is a cross-sectional view showing an exemplary embodiment of a docking station located in the pulmonary artery and a valve located within the docking station. [Figure 32A] This is a cross-section showing a human heart in systole with a docking station located within the pulmonary artery. [Figure 32B] This is a cross-section showing a systolic human heart with a docking station and transcatheter heart valve positioned in the pulmonary artery. [Figure 33A] Figure 32B is an enlarged schematic diagram showing the docking station and transcatheter heart valve when the heart is in systole. [Figure 33B] This is a view in the direction indicated by the line 33B-33B in Figure 33A. [Figure 34] This is a cutaway diagram showing a human heart in diastole, a docking station located in the pulmonary artery as shown in Figure 32B, and a transcatheter heart valve. [Figure 35A] This is an enlarged schematic diagram showing the docking station and transcatheter heart valve in the diastolic state of the heart (Figure 34). [Figure 35B] This is a view in the direction indicated by the line 35B-35B in Figure 35A. [Figure 36A] This is a cross-section showing a human heart in systole with a docking station located within the pulmonary artery. [Figure 36B] This is a cross-section showing a human heart in systole with a docking station located within the pulmonary artery. [Figure 36C] This is a cross-section showing a systolic human heart with a docking station and transcatheter heart valve positioned in the pulmonary artery. [Figure 37A] Figure 36C is an enlarged schematic diagram showing the docking station and transcatheter heart valve when the heart is in systole. [Figure 37B] This is a view in the direction indicated by the line 37B-37B in Figure 37A. [Figure 38] This is a cutaway diagram showing a human heart in diastole, a docking station located in the pulmonary artery as shown in Figure 36C, and a transcatheter heart valve. [Figure 39A] Figure 38 is an enlarged schematic diagram showing the docking station and transcatheter heart valve when the heart is in diastole. [Figure 39B] This is a view in the direction indicated by the line 39B-39B in Figure 39A. [Figure 40A] This is a cross-section showing a human heart in systole with a docking station located within the pulmonary artery. [Figure 40B] This is a cross-section showing a human heart in systole with a docking station located within the pulmonary artery. [Figure 40C] This is a cross-section showing a systolic human heart with a docking station and transcatheter heart valve positioned in the pulmonary artery. [Figure 41A] Figure 40C is an enlarged schematic diagram showing the docking station and transcatheter heart valve when the heart is in systole. [Figure 41B] This is a view in the direction indicated by line 41B-41B in Figure 41A. [Figure 42]This is a cutaway diagram showing a human heart in diastole, a docking station located in the pulmonary artery as shown in Figure 40C, and a transcatheter heart valve. [Figure 43A] This is an enlarged schematic diagram showing the docking station and transcatheter heart valve in the diastolic state of the heart (Figure 42). [Figure 43B] This is a view in the direction indicated by the line 43B-43B in Figure 43A. [Figure 44] This figure shows examples of valve types that may be deployed within a docking station, such as one of the docking stations described or depicted herein. [Figure 45] This figure shows examples of valve types that may be deployed within a docking station, such as one of the docking stations described or depicted herein. [Figure 46] This figure shows examples of valve types that may be deployed within a docking station, such as one of the docking stations described or depicted herein. [Figure 47] This figure shows examples of valve types that may be deployed within a docking station, such as one of the docking stations described or depicted herein. [Figure 48A] This figure shows examples of valve types that may be deployed within a docking station, such as one of the docking stations described or depicted herein. [Figure 48B] This figure shows examples of valve types that may be deployed within a docking station, such as one of the docking stations described or depicted herein. [Figure 48C] This figure shows examples of valve types that may be deployed within a docking station, such as one of the docking stations described or depicted herein. [Figure 49A] This is a cross-sectional view showing an exemplary embodiment of a catheter. [Figure 49B]This is a cross-sectional view showing an exemplary embodiment of a catheter in which the docking station is folded and loaded into the catheter. [Figure 50A] This diagram shows the deployment of docking stations from catheters. [Figure 50B] This diagram shows the deployment of docking stations from catheters. [Figure 50C] This diagram shows the deployment of docking stations from catheters. [Figure 50D] This diagram shows the deployment of docking stations from catheters. [Figure 51] This is a side view showing an exemplary embodiment of the nose cone of a catheter. [Figure 52] This is a view as shown by line 52-52 in Figure 51. [Figure 53] This is a side view showing an exemplary embodiment of the distal portion of a catheter. [Figure 54] This is a side view showing an exemplary embodiment of the nose cone of a catheter. [Figure 55] This is a side view showing an exemplary embodiment of the distal portion of a catheter. [Figure 56] This is a perspective view showing a holder that secures the docking station within the catheter. [Figure 57] This is a perspective view showing a holder that secures the docking station within the catheter. [Figure 57A] This is a side view showing the extension of the docking station located inside the holder. [Figure 57B] This is a side view showing the extension of the docking station located inside the holder. [Figure 58] This is a cross-sectional view showing an exemplary embodiment of the handle of a docking station catheter. [Figure 59] Figure 58 is an exploded and assembled perspective view showing the handle section. [Figure 60] Figure 58 is an exploded cross-sectional view showing the handle portion. [Figure 61]Figure 58 is an exploded and assembled perspective cross-sectional view showing the handle portion. [Figure 62] This figure shows an exemplary embodiment of the handle of a docking station catheter with the side cover removed. [Figure 63] This is an enlarged view of Figure 62, which shows the catheter cleaning system. [Figure 64A] Figure 62 shows a diagram of the handle with the opposite side cover removed to demonstrate extension and retraction of the outer sleeve of the docking station catheter. [Figure 64B] Figure 62 shows a diagram of the handle with the opposite side cover removed to demonstrate extension and retraction of the outer sleeve of the docking station catheter. [Figure 65] Figure 62 is an exploded assembly diagram showing the handle. [Figure 66] Figure 62 shows a perspective view of the handlebars with the opposite side cover removed. [Figure 67] Figure 62 is a side view of the handle. [Figure 68] This is a side view showing the indexing wheel of the handle shown in Figure 62, in the ratcheted state. [Figure 69] This is a perspective view showing the indexing wheel in the ratcheted state (Figure 68). [Figure 70] This is an enlarged section of Figure 69. [Figure 71] This is a partial cross-sectional view showing the indexing wheel, as shown in Figure 68, located within the handle housing. [Figure 72] This figure is similar to Figure 71, which shows the engaged / disengaged state. [Figure 73] This is a side view showing the indexing wheel of the handle shown in Figure 62, in the engaged / disengaged state. [Modes for carrying out the invention]

[0029] The following description refers to the accompanying drawings illustrating specific embodiments of the invention. Other embodiments having different structures and operations do not depart from the scope of the invention. Exemplary embodiments of this disclosure relate to devices and methods that provide a docking station or landing area for a transcatheter cardiac valve ("THV"), e.g., THV 29. In some exemplary embodiments, the docking station for the THV is shown as being used in the pulmonary artery, but the docking station (e.g., docking station 10) may be used in other areas of the anatomical structure, heart, or vascular system, such as the superior or inferior vena cava. The docking stations described herein can be configured to compensate for the fact that the deployed THV is smaller than the space in which the THV is placed (e.g., anatomical structure / vascular system / other).

[0030] Various embodiments of docking stations and systems for delivery and embedding are disclosed herein, and it should be noted that these options may be combined in any way unless explicitly excluded. For example, any of the disclosed docking station devices may be used with any type of valve and / or any delivery system, even if no particular combination is expressly described. Similarly, different structures of docking stations and valves may be mixed and harmonized, such as by combining any type / features of docking stations, types / features of valves, tissue covers, etc., even if not expressly disclosed. In short, individual components of the disclosed systems may be combined unless they are mutually exclusive or otherwise physically impossible.

[0031] For consistency, in these drawings and other materials of this application, the docking station is depicted with the pulmonary artery bifurcation end facing upwards and the ventricular end facing downwards. These directions may also be referred to as “distal” (synonymous with the upper or pulmonary artery bifurcation end) and “proximal” (synonymous with the lower or ventricular end), and these are terms from the physician’s perspective.

[0032] Figures 1A and 1B are cross-sections of a human heart H in diastole and systole, respectively. The right ventricle (RV) and left ventricle (LV) are separated from the right atrium (RA) and left atrium (LA) by the tricuspid valve (TV) and mitral valve (MV), i.e., 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 leaflets that extend inward across their respective orifices, forming a single unit or "joining" in the flow to create a unidirectional fluid-occluded surface. The docking stations and valves of this application will be described primarily with respect to the pulmonary valve. Therefore, the anatomical structures of the right atrium (RA) and right ventricle (RV) will be described in more detail. It should be understood that the devices described herein may also be used in other areas, such as in the inferior and / or superior vena cava as treatment for regurgitation or other defects of the tricuspid valve, in the aorta as treatment for a defective aortic valve (e.g., aortic hypertrophy), in other areas of the heart or vascular system, and in grafts.

[0033] The right atrium (RA) receives deoxidized 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 connect to each other to form a large vessel that collects deoxidized blood from the heart muscle (myocardium) and delivers it to the right atrium (RA). During diastole, or cardiac systole, as shown in Figure 1A, the venous blood that collects in the right atrium (RA) enters the tricuspid valve (TV) by the dilation of the right ventricle (RV). During systole, or cardiac contraction, as shown in Figure 1B, the right ventricle (RV) contracts, pushing venous blood to the lungs through the pulmonary valve (PV) and pulmonary artery. In one exemplary embodiment, the device described herein is used to replace or supplement the function of a defective pulmonary valve. During cardiac contraction, the leaflets of the tricuspid valve (TV) close to prevent venous blood from flowing back into the right atrium (RA).

[0034] Referring to Figures 2A–2E and 3A–3D, the non-exclusive examples shown illustrate that pulmonary arteries can have a wide variety of shapes and sizes. For example, as shown in the cross-sectional views in Figures 2A–2E and the perspective views in Figures 3A–3D, length L, diameter D, and curvature or contour can vary considerably between pulmonary arteries of different patients. Furthermore, diameter D can vary considerably along the length L of individual pulmonary arteries. These differences may be even more pronounced in pulmonary arteries suffering from certain diseases and / or damaged by past surgical procedures. For example, treatment for Tetralogy of Fallot (TOF) or transposition of the aorta (TGA) often results in larger and more irregularly shaped pulmonary arteries.

[0035] Tetralogy of Fallot (TOF) is a cardiac anomaly that refers to a combination of four commonly occurring related cardiac defects. The four defects are ventricular septal defect (VSD), overriding aorta (enlargement of the aortic valve, causing it to appear as if the heart is discharging from both ventricles instead of the left ventricle as in a normal heart), pulmonary stenosis (narrowing of the pulmonary valve and the outflow tract or area below the valve, causing obstruction of blood flow from the right ventricle to the pulmonary artery), and right ventricular hypertrophy (thickening of the muscular wall of the right ventricle, caused by the right ventricle pumping under high pressure).

[0036] Transposition of the aorta (TGA) is an abnormality in which the aorta and pulmonary artery "transpose" from their normal positions, causing the aorta to emerge from the right ventricle and the pulmonary artery to emerge from the left ventricle.

[0037] Surgical treatment of several diseases requires a longitudinal incision along the pulmonary artery, down to one of its branches. This incision may eliminate or significantly impair the function of the pulmonary valve. Transannular patches are used to cover the incision after surgery. Transannular patches reduce pulmonary artery stenosis or restriction diseases associated with other surgical procedures. However, impairment or elimination of the pulmonary valve (PV) can result in significant regurgitation, and prior to this invention, it was often necessary to perform a subsequent open-chest surgery to replace the pulmonary valve. Transannular patch technology can accommodate a wide range of pulmonary arteries of varying sizes and shapes (see Figures 3A–3D).

[0038] Referring to Figures 4A to 4F, in one exemplary embodiment, the expandable docking station 10 includes one or more sealing portions 410, a valve seat 18, and one or more retaining portions 414. The sealing portions 410 provide a seal between the docking station 10 and the inner surface 416 of the circulating system. The valve seat 18 serves as a support surface for embedding or deploying the valve 29 within the docking station 10 after the docking station 10 has been embedded in the circulating system. The retaining portions 414 help to retain the docking station 10 and the valve 29 in their embedded or deployed positions within the circulating system. The expandable docking station 10 and valve 29 as described in various embodiments herein also represent various docking stations and / or valves that may be known or developed, for example, various different types of valves may be used as substitutes for and / or as valve 29 in various docking stations.

[0039] Figures 4A–4D schematically illustrate exemplary deployments of the docking station 10 and valve 29 within the circulatory system. Referring to Figure 4A, the docking station 10 is in a compressed form / configuration and is introduced into the deployment site within the circulatory system. For example, the docking station 10 may be positioned in the deployment site within the pulmonary artery by a catheter (e.g., catheter 3600 as shown in Figures 50A–50D). Referring to Figure 4B, the docking station 10 is expanded within the circulatory system such that the sealing portion 410 and the retaining portion 414 engage with the inner surface 416 of a portion of the circulatory system. Referring to Figure 4C, after the docking station 10 has been deployed, the valve 29 is in a compressed form and is introduced into the valve seat 18 of the docking station 10. Referring to Figure 4D, the valve 29 is expanded within the docking station so that the valve 29 engages with the valve seat 18. In the examples described herein, the docking station 10 is longer than the valve. However, in other embodiments, the docking station 10 may be the same length as or shorter than the valve 29. Similarly, the valve seat 18 may be longer than, shorter than, or the same length as the valve 29.

[0040] Referring to Figure 4D, valve 29 expands, and the valve seat 18 of the docking station supports the valve. Valve 29 only needs to expand to the narrow valve seat 18, rather than to the wider space within the portion of the circulatory system occupied by the docking station 10. The docking station 10 allows valve 29 to operate within the expansion diameter range for which it is designed.

[0041] Figure 4E shows that the size and / or shape of the cross-section of an inner surface 416 of the circulatory system, such as the inner surface of the blood vessels or anatomical structures of the heart, may vary along its length. In an exemplary embodiment, the docking station 10 is configured to extend radially outward to varying degrees along its length L to match 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 retaining portion engage with the inner surface 416, even though the shape of the blood vessels or anatomical structures of the heart varies considerably along the length L of the docking station. The docking station can be made from a highly elastic or adaptable material to accommodate large variations in anatomical structures. For example, the docking station can be made from 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, but other metals and highly elastic or adaptable non-metallic materials can be used. For example, the docking station 10 may have a frame or a portion of a frame (e.g., a self-expanding frame, a retaining portion, a sealing portion, a valve seat, etc.) made from these materials, or from a shape memory material such as nitinol. These materials allow the frame to be compressed to a small size, and then when the compressive force is released, the frame self-expands back to its pre-compression diameter.

[0042] An example of an open-cell foam that can be used to form a docking station or a portion of a docking station is a biocompatible foam such as polyurethane foam (e.g., available from Biometrix, Rockville, MD). The docking station described herein is expandable using a self-expanding and / or inflatable device, and the docking station can engage an inner surface 416 having a variable shape.

[0043] Figure 4F shows a docking station 10 and valve 29 embedded in the pulmonary artery PA. As mentioned with respect to Figures 2A-2E and 3A-3D, the shape of the pulmonary artery can vary considerably along its length. In one exemplary embodiment, the docking station 10 is configured to conform to the varying shape of the pulmonary artery PA, in the same manner as described with respect to Figure 4E.

[0044] Referring to Figures 5A to 5F, in one exemplary embodiment, the expandable docking station 10 is made from an expandable foam material, such as open-cell biocompatible foam. The outer surface 510 of the foam material can serve as a 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 a valve seat. In the example shown in Figures 5A to 5F, the retaining portion 414 is omitted, but a retaining portion can be used. In one embodiment, the foam material can be used with an expandable frame (e.g., metal, shape memory material). The foam material can cover or extend only the entire length of the frame or only a portion of the length of the frame.

[0045] Figures 5A to 5D schematically show the deployment of the foam docking station 10 and valve 29 within the circulatory system. Referring to Figure 5A, the docking station 10 is in a compressed form and is introduced into the deployment site in the circulatory system. For example, the docking station 10 may be positioned in the deployment site within the pulmonary artery by a catheter (e.g., catheter 3600 shown in Figures 50A to 50D). Referring to Figure 5B, the docking station 10 is expanded within the circulatory system so that the sealing portion 410 engages with the inner surface 416 of the circulatory system. Referring to Figure 5C, after the docking station 10 has been deployed, the valve 29 is in a compressed form and is introduced onto the valve seat 18 or inner surface 512 of the docking station 10. Referring to Figure 5D, the valve 29 is expanded within the docking station so that the valve 29 engages with the valve seat 18 or inner surface 512 (e.g., if the inner surface 512 acts as the valve seat).

[0046] Figure 5E shows that the cross-section of the inner surface 416 of the circulatory system, such as the inner surface of the blood vessels or anatomical structures of the heart, can vary along its length. In one exemplary embodiment, the foam docking station 10 is configured to extend radially outward to varying degrees along its length L to match the shape of the inner surface 416.

[0047] Figure 5F shows a foam docking station 10 and valve 29 embedded in the pulmonary artery PA. As mentioned with respect to Figures 2A–2E and 3A–3D, the shape of the pulmonary artery can vary considerably along its length. In one exemplary embodiment, the docking station 10 is configured to conform to the varying shape of the pulmonary artery PA in the same or similar form as described with respect to Figure 4E.

[0048] Referring to Figure 6A, a docking station, such as those described in Figures 4A-4D, is located within the pulmonary artery PA of the heart H. Figure 6B shows the valve 29 located within the docking station 10 shown in Figure 6A. In Figures 6A and 6B, the heart is in systole. Figure 7A is a magnified representation of the docking station 10 and valve 29 in the pulmonary artery in Figure 6B. When the heart is in systole, the valve 29 is open. Blood flows from the right ventricle RV through the pulmonary artery PA, docking station 10, and valve 29, as indicated by arrow 602. Figure 7B shows space 608 representing the open valve 29 when the heart is in systole. For simplicity of the drawing, Figure 7B does not show the interface between the docking station 10 and the pulmonary artery. The oblique lines in Figure 7B indicate blood flow through the open valve. In one exemplary embodiment, the sealing portion 410 prevents blood from flowing between the pulmonary artery PA and the docking station 10, and the valve 29 is housed in the valve seat 18 of the docking station 10, thereby preventing blood from flowing between the docking station 10 and the valve 29. In this example, blood flows, or can flow, only through the valve 29 when the heart is in systole.

[0049] Figure 8 shows the valve 29, docking station 10, and heart H as shown in Figure 6B when the heart is in diastole. Referring to Figures 9A and 9B, when the heart is in diastole, the valve 29 is closed. Figure 9A is a magnified representation of the docking station 10 and valve 29 within the pulmonary artery 29 in Figure 8. Blood flow within the pulmonary artery PA (i.e., within the pulmonary artery branch 760) above the valve 29 is obstructed by the closure of the valve 29, obstructing blood flow as indicated by the arrow 900. The solid region 912 in Figure 9B represents the closed state of valve 29 when the heart is in diastole.

[0050] In one exemplary embodiment, the docking station 10 prevents or substantially prevents the radially outward force of the valve 29 from being transferred to the inner surface 416 of the circulation system. Expanded valve It functions as such. In one embodiment, the docking station 10 includes a valve seat 18 (which is not expanded radially outward by the radially outward force of the THV or valve 29, or substantially expanded radially outward; i.e., the diameter of the valve seat is not increased by the force of the THV, or does not increase by more than 4 mm), and a fixing / retaining portion 414 and a sealing portion 410 which apply relatively small radially outward forces 720, 722 to the inner surface 416 of the circulation system (compared to the radially outward force applied to the valve seat 18 by the valve 29).

[0051] When a docking station is not used, the stent and frame of the THV are held in place in the circulating system by a relatively high radially outward force 710 of the stent or frame 712 of the THV acting directly on the inner surface 416 of the circulating system. When a docking station is used, as in the example shown in Figure 7A, the stent or frame 712 of the valve 29 expands radially outward, or is expanded radially outward, to impart a large force 710 to the valve seat 18 of the docking station 10. This large radially outward force 710 fixes the valve 29 to the valve seat 18 of the docking station 10. However, since the valve seat 18 is not expanded by the force 710, or is not substantially expanded, the force 710 is isolated from the circulating system rather than being used to fix the docking station in the circulating system.

[0052] In one 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 half, less than one-third, less than one-quarter, less than one-eighth, or even less than one-tenth of the radially outward force 710 applied by the valve. In one exemplary embodiment, the radially outward force 722 of the sealing portion 410 is selected to provide a seal between the inner surface 416 and the sealing portion 410, but is insufficient on its own to maintain the position of the valve 29 and the docking station 10 in the circulating system.

[0053] In one exemplary embodiment, the radially outward force 720 of the fixing / retaining portion 414 to the inner surface 416 is substantially less than the radially outward force 710 applied to the valve seat 18 by the valve 29. For example, the radially outward sealing force 720 can be less than half, less than one-third, less than one-quarter, less than one-eighth, or even less than one-tenth of the radially outward force 710 applied by the valve.

[0054] In one exemplary embodiment, the radially outward force 720 of the retaining portion 414 is insufficient on its own to retain the position of the valve 29 and docking station 10 within 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 Figure 6A, when the heart is in systole, the valve 29 is open and blood flows through the valve as indicated by arrow 602. Since the valve 29 is open and blood is flowing through it, the pressure P exerted by the blood on the docking station 10 and valve 29 is low, as indicated by the small arrow P shown in Figure 7A. Although the pressure P is low, it presses the docking station and its upper retaining portion 414 against the surface 416 in a direction approximately indicated by arrow F. This blood-flow-assisted force F exerted on the surface 416 by the retaining portion 414 prevents the docking station 10 and valve 29 from moving in the direction of blood flow 602 during systole of the heart H.

[0055] Referring to Figure 9A, when the heart is in diastole, valve 29 is closed and blood flow is obstructed as indicated by arrow 900. Since valve 29 is closed and valve 29 and docking station 10 obstruct blood flow, the pressure P exerted by the blood on docking station 10 and valve 29 is high, as indicated by the large arrow P in Figure 9A. This high pressure P presses the lower retaining portion 414 against surface 416 in approximately the direction indicated by the large arrow F. This blood flow-assisted force F exerted on surface 416 by retaining portion 414 prevents docking station 10 and valve 29 from moving in the direction indicated by arrow 900.

[0056] The forces applied by the upper and lower restraint portions 414 are determined by the amount of pressure exerted on the valve 29 and docking station 10 by the blood, so the forces applied to the surface 416 are automatically proportional. That is, the force exerted by the upper restraint portion against the surface 416 when the heart is in systole is weaker than the force exerted by the lower restraint portion against the 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.

[0057] The valve seat 18 and the sealing portion 410 can be of a wide variety of different forms. For example, the valve seat 18 can be any structure that does not expand radially outward, or substantially does not expand 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 at all or expand by less than 4 mm, for example, the diameter may expand by only 1 to 4 mm when the valve is deployed on the valve seat). For example, the valve seat 18 may be equipped with sutures or metal rings that resist or limit expansion. However, in one embodiment, the valve seat 18 (or any valve seat described herein) may be expandable over a wider range, for example, the diameter may expand by 5 mm to 30 mm when the valve is deployed on the valve seat. In one embodiment, the diameter may expand from a diameter of 5 mm or 6 mm to a diameter of 20 mm to 29 mm, 24 mm, 26 mm, 29 mm, etc., or from different diameters within that range to different diameters. Even if further expansion is possible, the valve seat may remain limited in its expansion, for example, to prevent it from expanding beyond the expanded diameter of the valve it is positioned on, or to prevent it from expanding beyond the diameter that securely holds the valve within the valve seat due to the forces between the valve and the valve seat. The valve seat 18 may be part of or define a part of the body of the docking station 10, or the valve seat 18 may be a separate component attached to the body of the docking station. The valve seat 18 may be longer than, shorter than, or the same length as the valve. The valve seat 18 may be significantly shorter than the valve 29 when the valve seat 18 is defined by sutures or a metal ring. The valve seat 18 formed by sutures or a metal ring may form a narrow circumferential seal line between the valve 29 and the docking station.

[0058] The sealing portion 410 in various embodiments can take on 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 circulating system. For example, the sealing portion 410 may include fabric, foam, biocompatible tissue, or a combination thereof. The sealing portion 410 may be part of or define a part of the body of the docking station 10, and / or the sealing portion 410 may be a separate component attached to the body of the docking station. The docking station 10 may include a single sealing portion 410, or two or more sealing portions.

[0059] As described above, in one exemplary embodiment, the sealing portion 410 is configured to apply a small radially outward force to the surface 416. This small radially outward force can be applied in a wide variety of different ways. For example, the sealing portion may be made from a highly compressible or highly adaptable material. Referring to Figure 7C, in one exemplary embodiment, the body of the docking station 10 is made from an elastic or superelastic metal. One such metal is nitinol. If the body of the docking station 10 is made from a lattice of metal compression material, the body can have spring properties. Referring to Figure 7C, like a spring, when the body of the docking station is not constrained and can be relaxed to its maximum diameter, the body of the docking station applies little to 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 in Figure 7C, in one exemplary embodiment, the relationship between the radially outward force on the docking station body and the expanded diameter of the docking station is nonlinear, although in one exemplary embodiment, the relationship can also be linear. In the example shown in Figure 7C, curve 750 shows the relationship between the radially outward force acting on the docking station 10 and the compressed diameter of the docking station. In region 752, curve 750 has a small slope. In this region 752, the radially outward force is small and changes only slightly. In one exemplary embodiment, region 752 corresponds to a diameter of 25mm to 40mm, such as 27mm to 38mm. The radially outward force is small but not zero in region 752. In region 754, curve 750 has a larger slope. In this region 754, the radially outward force increases significantly as the docking station is compressed. In one exemplary embodiment, the stent body is constructed so that it lies in region 752 of the small slope. This ensures that the sealing portion 710 applies only small radially outward forces to the inner surface 416 of the circulation system over a wide diameter.

[0060] The retention portion 414 can take on a wide variety of different forms. For example, the retention portion 414 may be any structure that positions the docking station 10 within the circulatory system. For example, the retention portion 414 may position the docking station 10 by being in contact with or pressed into the inner surface 416, or by extending around the anatomical structure of the circulatory system. The retention portion 414 may be part of or define a part of the body of the docking station 10, or the retention portion 414 may be a separate component attached to the body of the docking station. The docking station 10 may include a single retention portion 414, or two or more retention portions.

[0061] Figures 10A to 10C show that the docking station 10 may have any combination of one or more different types of valve seats 18 and sealing portions 410. In the example shown in 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 in 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 in 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 in 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.

[0062] As described above, the lengths of the pulmonary artery (PA) and other anatomical structures of the circulatory system can vary considerably from patient to patient. Referring to Figures 11A–11D, in one exemplary embodiment, the length of the docking station 10 is adjustable, as indicated by arrow 1100. This adjustability 1100 refers to the ability to adjust the post-implantation / post-expansion length of the docking station, rather than the length change that inherently occurs when the stent expands from a compressed to an expanded state. The length may be adjusted in a wide variety of different ways. In the example shown by Figures 11A–11D, the docking station 10 includes a first half 1102 and a second half 1104. As used herein, the use of the term “half” in relation to a two-part docking station is synonymous with “part” and does not require 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 into or "fitted" into the first half 1102. The length of the docking station 10 is determined by the amount of insertion or "fitting". Any of the docking stations 10 illustrated and described in this patent application can be length-adjustable by creating a docking station from two parts that are nested into each other or otherwise adjustable relative to each other. In one embodiment, the length of a single-piece docking station can be foldable and expandable. In one embodiment, the docking station may be formed from a material whose shape can be changed to adjust its length. In one embodiment, more than two parts (e.g., three, four, or more parts) can be combined in a similar manner and may include one or more features similar to the first half 1102 and the second half 1104.

[0063] In one exemplary embodiment, the length of the docking station 10 can be adjusted within the pulmonary artery PA by first deploying the first half 1102 of the docking station 10 within the pulmonary artery. For example, the first half 1102 may be positioned and expanded as desired so 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 has been expanded within the pulmonary artery, a compressed second half 1104 can be positioned so that its distal end 1110 is aligned with the proximal end 1108 of the first half 1102. In one embodiment, the position of the second half 1104 is selected so that the sealing portion 410 and the retaining portion 414 are in contact with 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 with the proximal end 1108 of the first half to secure the two halves 1102 and 1104 together. In one embodiment, locks, latching mechanisms, sutures, crosses, links, and / or other mounting devices / mechanisms may be used to assist in securing the halves / parts together.

[0064] In the example shown in Figures 11A to 11D, the valve seat 18 and 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 sealing portion 410 may be included on the first half 1102. Figures 11A to 11C show that the halves 1102 and 1104 of the docking station 10 may have any combination of different types of valve seats 18 and sealing portions 410. In the example shown in Figure 11A, the valve seat 18 is a separate component attached to the body of the docking station half 1104, and the sealing portion is formed integrally with the body of the docking station half 1104. In the example shown in Figure 11B, the valve seat 18 is a separate component attached to the body of the docking station half 1104, and the sealing portion 410 is a separate component attached to the body of the docking station half 1104. In the example shown in Figure 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 in Figure 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.

[0065] Figures 12A to 12D show exemplary embodiments of a docking station 10 having two sealing portions 410. The docking station 10 may have any combination of one or more different types of valve seats 18 and sealing portions 410. In the example shown by Figure 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 Figure 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 Figure 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 Figure 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.

[0066] Figures 13A to 13D show that the docking station shown in Figures 12A to 12D may be a two-piece nesting docking station. The pieces 1102 and 1104 of the docking station 10 may 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 in Figure 13A, the first half 1102 includes an integral sealing portion 410. The second half 1104 includes a valve seat 18 which 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 in Figure 13B, the first half 1102 includes a sealing portion 410 which is separate from the body of the first half 102. The valve seat 18 is a separate component attached to the body of the docking station 10, and the sealing portion 410 is a separate component attached to the body of the docking station. In the example shown in Figure 13C, the first half 1102 includes an integral sealing portion 410. The valve seat 18 is integrally formed with the body of the second half 1104 of the docking station 10, and the sealing portion 410 is integrally formed with the body of the second half 1104. In the example shown in Figure 13D, the first half 1102 includes a sealing portion 410 that is separate from the body of the first half 102. The valve seat 18 is integrally formed with the body of the second half 1104 of the docking station 10, and the sealing portion 410 is a separate component attached to the body of the second half 1104.

[0067] Referring to Figures 14A to 14G, in an exemplary embodiment, the docking station 10 may 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, no portion of the docking station that does not seal the inner surface 416 of the circulatory system or seals the valve 29 obstructs blood flow. For example, the docking station 10 may extend into a branch of the pulmonary artery, and the portion 1400 of the docking station 10 extending into the pulmonary artery allows blood to flow freely through the docking station 10. In one exemplary embodiment, blood can flow freely through the permeable portion 1400 so that 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.

[0068] The impermeable portion 1404 can take on a wide variety of different forms. The impermeable portion 1404 may be any structure or material that prevents blood from flowing through the impermeable portion 1404. For example, the body of the docking station 10 may be formed from wires or grids such as nitinol wire or grids, and the cells of the body may be covered with an impermeable material (see Figure 18). A wide variety of different materials may be used as the impermeable material. For example, the impermeable material may be blood-impermeable fabric such as PET cloth or biocompatible covering materials such as fabric treated with a blood-impermeable coating, polyester, or processed biomaterials such as pericardium.

[0069] Figures 14A to 14G show that a wide variety of docking station configurations can include a permeable portion 1402. The sealing portion 410 may be formed integrally with the body of the docking station, as shown in Figures 14B, 14D, and 14F, or it may be separate, as shown in Figures 14C, 14E, and 14G. In Figures 14F and 14G, the docking station 10 includes the portion 1410. These portions 1410 are similar to the sealing portion 410, but since the portion 1410 is part of the permeable portion 1402, no seal is formed with the inner surface 416 of the circulation system. The valve seat 18 may be formed separately from the body of the docking station, as shown in Figures 14A to 14C, or it may be formed integrally with the body of the docking station 10, as shown in Figures 14D to 14G.

[0070] 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 wide variety of different forms, and Figures 15A, 15B, 16, 17A, and 17B show only one of many possible configurations. In the example shown by Figures 15A, 15B, 16, 17A, 17B, and 18, the docking station 10 has a relatively wide proximal inlet end 12 and a distal outlet end 14, and a relatively narrow portion 16 that forms a valve seat 18 between the ends 12, 14. In the example 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 a cell 1504. In the examples of Figures 15A, 15B, 17A, and 17B, the frame 1500 has a substantially hourglass shape, with a narrow section 16 between the proximal end 12 and the distal end 14 that, when covered with an impermeable material, forms a valve seat 18. As will be described later, the valve 18 expands within the narrow section 16, thereby forming the valve seat 18.

[0071] Figures 15A, 15B, 17A, and 17B show the frame 1500 in an unrestrained and extended state. In this exemplary embodiment, the restraining portion 414 has ends 1510 of a metal compression member 1502 at its proximal end 12 and distal end 14. The sealing portion 410 is between the restraining portion 414 and the lumbar portion 16. In the unrestrained state, the restraining portion 414 extends substantially radially outward and is radially outward of the sealing portion 410. Figure 16 shows the frame 16 in a compressed state for catheter delivery and expansion. The docking station can be made from a highly elastic or adaptable material to accommodate large variations in anatomical structure. For example, the docking station can be made from a highly flexible metal, alloy, polymer, or open-cell foam. Nitinol is an example of a highly elastic metal, but other metals and highly elastic or adaptable non-metallic materials can be used. The docking station 10 may be self-expanding, manually expandable (e.g., expandable by balloons), or mechanically expandable. The self-expanding docking station 10 may be made of a shape memory material such as nitinol.

[0072] Figure 18 shows a frame 1500 including an impermeable material 21 attached to the frame 1500 to form a docking station 10. Referring to Figure 18, in one exemplary embodiment, the band 20 extends around or integrally with the waist or narrower section 16 to form a non-expandable or substantially non-expandable valve seat 18. The band 20 reinforces the waist, and once the docking station is deployed and expanded, the waist / valve seat becomes relatively non-expandable in its post-deployment configuration. In the example shown by Figure 19, the valve 29 forms the valve seat 18 of the docking station 10 by being secured by its foldable frame expanding into the narrower section 16. As described above, the non-expandable or substantially non-expandable valve seat 18 prevents the radially outward force of the valve 29 from being transferred to the inner surface 416 of the circulating system. However, in another exemplary embodiment, the waist / valve seat of the deployed docking station may optionally expand slightly elastically when the valve is deployed thereto. Any elastic expansion of the lumbar region 18 can apply pressure to the valve 29, which can help hold the valve 29 in place within the docking station.

[0073] The band can take on a wide variety of different forms and can be made from a wide variety of different materials. The band 20 can be made from PET, one or more sutures, fabric, metal, polymer, biocompatible tape, or other relatively non-expandable material known in the art that is sufficient to maintain the shape of the valve seat 18 and hold the valve 29 in place. The band can extend around the outside of the stent or be an integral part of it, such as when the fabric or other material is woven into or through the cells of the stent. The band 20 may be narrow or wide, such as the suture band in Figure 18. The band can have a variety of widths, lengths, and thicknesses. In one non-limiting example, the valve seat 18 is 27-28 mm wide, but the diameter of the valve seat should be within the operating range of the particular valve 29 fixed within the valve seat 18 and may differ from the example above. The valve 29 may optionally be slightly expanded around either side of the valve seat when placed in the docking station. This configuration may be referred to as a "dogbone" (for example, due to the shape formed around the valve seat or band), and can also help to hold the valve in place.

[0074] Figures 20 and 21 show the docking station 10 of Figure 18 embedded in a circulatory system such as a pulmonary artery. The sealing portion 410 provides a seal between the docking station 10 and the inner surface 416 of the circulatory system. In the example of Figures 20 and 21, the sealing portion 410 is formed by providing an impermeable material 21 (see Figure 21) on the frame 1500 or a portion thereof. In particular, the sealing portion 410 may comprise a rounded radially outward-extending portion 2000 on the underside of the frame 1500. In one exemplary embodiment, the impermeable material 21 extends at least from the portion 2000 of the frame 1500 to the valve seat 18. This makes the docking station impermeable from the sealing portion 410 to the valve seat 18. Thus, all blood flowing in the inflow direction 12 and outflow direction 14 is directed to the valve seat 18 (and also to the valve 29 when loaded or deployed within the valve seat).

[0075] In a preferred embodiment of the docking station 10, the inlet portion has a blood-impermeable wall, while the outlet portion has a relatively open wall. In one approach, portions of the inlet end portion 12, the intermediate compartment 16, and the outlet end portion 14 are covered with a blood-impermeable fabric 21, which may be sewn onto the stent or attached by another method known in the art. The impermeability of the inlet portion of the stent helps to draw blood into the docking station 10 and ultimately drain it through a valve that expands and is secured within the docking station 10.

[0076] From another perspective, this embodiment of the docking station is designed to seal the proximal inflow compartment 2000 to create a conduit for blood flow. However, the distal outflow compartment remains largely open, thereby allowing the docking station 10 to be positioned high within the pulmonary artery without restricting blood flow. For example, the permeable portion 1400 may extend into the branches of the pulmonary artery but not obstruct or significantly obstruct blood flow beyond the branches. In one embodiment, a blood-impermeable fabric, such as PET cloth, or another material, covers the proximal inflow compartment, but the covering does not cover any or at least a portion of the distal outflow compartment 14. In one non-limiting example, when the docking station 10 is positioned within the pulmonary artery, a large vessel, a significant amount of blood flowing through the artery is delivered to the valve 29 by the fabric covering 21. Since the fabric 21 is fluid-impermeable, blood cannot pass through it. In fact, various other biocompatible covering materials may be used, such as foams or fabrics, polyesters, or processed biomaterials such as pericardium, that have been treated with a blood-impermeable coating.

[0077] In the example shown in Figure 21, more docking station frames 1500 are provided with the impermeable material 21, forming a relatively large impermeable portion 1404. In the example shown in Figure 21, the impermeable portion 1404 extends from the inlet end 12 and ends in a row of cells 1504 just before the outlet end. Thus, the most distal row of cells 1504 forms a permeable portion 1400. However, it is possible for more rows of cells 1504 not to be covered with the impermeable material, forming a larger permeable portion. The permeable portion 1400 allows blood to enter and exit region 2130, as indicated by arrow 2132. With respect to the inlet end 12, it should be noted that since the cells 1504 are roughly rhomboid in shape, blood can flow between the docking station 10 and the surface 416 until it reaches the sealing portion 410. That is, in one exemplary embodiment, blood can enter and exit region 2100.

[0078] The valve seat 18 can serve as a support surface for embedding or deploying the valve 29 within the docking station 10. The retaining portion 414 can retain the docking station 10 in its implantation or deployment site within the circulatory system. The illustrated retaining portion has an outwardly curved flare that helps to fix the docking station 10 in the artery. “Outward” as used herein means extending away from the central longitudinal axis of the docking station. As can be seen in Figure 20, when the docking station 10 is compressed by the inner surface 416, the retaining portion 414 engages the surface 416 at an angle α (from the normal to the surface of the retaining portion 414 to the tangent to the center point on the surface), and the angle can be 30 to 60 degrees, such as about 45 degrees, rather than extending substantially radially outward as in the uncompressed state (see Figure 15B) (i.e., α is 0 to 20 degrees or about 10 degrees). This inward curve of the retaining portion 414, as indicated by arrow 2020, acts to retain the docking station 10 within the circulatory system. The retaining portion 14 is located in the wider inlet and outlet portions 14 and compresses the inner surface 416. The flared retaining portion 414 engages within the surrounding anatomical structures within the circulatory system, such as the pulmonary artery space. In one exemplary embodiment, the flare acts as a stopper that locks the device in place. When an axial force is applied to the docking station 10, the flared retaining portion 414 is pushed into the surrounding tissue by the force to resist stent movement, as will be described in more detail later. In certain embodiments, the docking station generally has an hourglass shape, with wider distal and proximal end portions having the flared retaining portion and a narrower, band-shaped waist portion between the ends, within which the valve expands.

[0079] Figure 22 shows a docking station 10 deployed within the circulating 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 state and introduced onto the valve seat 18 of the docking station 10. The valve 29 expands within the docking station so that it engages with the valve seat 18. In the example shown in 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 the valve 29 or shorter.

[0080] The valve 29 may be delivered to a portion of the docking station by conventional means, such as by ballooning, mechanical expansion, or self-expansion. Once expanded, the valve 29 fits into the valve seat of the docking station 10. In one embodiment, the band-shaped waist is slightly elastic and exerts an elastic force on the valve 29 to help hold the THV in place.

[0081] Figures 23A and 23B show that the docking station 10 can be used to accommodate various different sizes of anatomical structures in the circulatory system in order to implant a valve 29 having a fixed size. In the example in Figures 23A and 23B, docking stations 10 of the same size are deployed in two different sized vessels 2300 and 2302, such as two different sized pulmonary arteries PA. In that example, the vessel 2300 shown by Figure 23A has a larger effective diameter than the vessel 2302 shown by Figure 23B. (Note that in this patent application, the size of circulatory system anatomical structures is referred to as “diameter” or “effective diameter.” Circulatory system anatomical structures are often not circular. The terms “diameter” and “effective diameter” refer, as herein, to the diameter of a circle or disc that can be deformed to fit into a non-circular anatomical structure.) In the example shown in Figures 23A and 23B, the sealing portion 410 and the retaining portion 414 are adapted to contact each vessel 2300, 2302. However, the valve seat 18 remains the same size even when the sealing portion 410 and the retaining portion 414 are compressed. Thus, the docking station 10 adapts to a wide variety of different anatomical structure sizes to embed standard or single-size valves. For example, the docking station may adapt to vessel diameters of 25mm to 40mm, such as 27mm to 38mm, and provide valve seats of constant or substantially constant diameters of 24mm to 30mm, such as 27mm to 28mm. However, the valve seat 10 can be adapted to applications where the vascular diameter is greater than or less than 25 mm to 40 mm, and where a valve seat is greater than or less than 24 mm to 30 mm.

[0082] Referring to Figures 23A and 23B, the band 20 maintains a constant or substantially constant diameter of the valve seat 18, even as it expands to the respective diameters required for the proximal and distal ends of the docking station to engage with the inner surface 416. Although the diameter of the pulmonary artery PA may vary considerably from patient to patient, the valve seat 18 in the deployed configuration consistently has a diameter within an acceptable range for the valve 29.

[0083] Figures 24 and 25 show cross-sections of the docking station 10 shown in Figure 18 when a schematic transcatheter heart valve 29 of the same size is loaded or deployed in each docking station 10 and implanted in blood vessels 2300, 2302 of different sizes in the circulatory system. In this example, the docking station 10 adapts to blood vessels 2300, 2302 of various different sizes and acts as an isolator that prevents or substantially prevents the radially outward force of the valve 29 from being transferred to the blood vessel. The valve seat 18 is not expanded radially outward by the radially outward force of the valve 29, or substantially expanded radially outward, and the fixing / retaining portion 414 and sealing portion 410 exert only a relatively small radially outward force on the blood vessels 2300, 2302 (compared to the radially outward force applied to the valve seat 18 by the valve 29), even when the docking station is deployed in blood vessels 2302 of smaller diameter.

[0084] In the example shown in Figures 24 and 25, the stent or frame 712 of the valve 29 expands radially outward, or is expanded radially outward to impart 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 substantially not expanded, by the force 710, the force 710 is isolated from the circulating system rather than being used to secure the docking station within the circulating system.

[0085] In one exemplary embodiment, the radially outward force 722 of the sealing portion 410 for both larger and smaller vessels 2300 is substantially less than the radially outward force 710 applied by the valve 29 to the valve seat 18. For example, for the smallest vessel to which the docking station 10 is fitted for embedding the valve, the radially outward sealing force 722 can be less than half, less than one-third, less than one-quarter, less than one-eighth, or even less than one-tenth of the radially outward force 710 applied by the valve. In one exemplary embodiment, the radially outward force 722 of the sealing portion 410 is selected to provide a seal between the inner surface 416 and the sealing portion 410, but is insufficient on its own to hold the valve 29 and the docking station 10 in place within the circulatory system. In one embodiment, the radially outward force 722 is sufficient to maintain the position of the valve 29 and the docking station 10 within the circulation system.

[0086] In one exemplary embodiment, the docking station 10 shown in Figure 18 also includes a fixing / retaining portion 414 that applies a radially outward force 720 substantially less than the radially outward force 710 applied by the valve 29 to the valve seat 18. For example, for the smallest vessel to which the docking station 10 is fitted for embedding the valve, the radially outward sealing force 720 can be less than half, less than one-third, less than one-quarter, less than one-eighth, or even less than one-tenth of the radially outward force 710 applied by the valve. In one embodiment, the radially outward force 720 of the fixing / retaining portion 414 is insufficient on its own to retain the position of the valve 29 and the docking station 10 in the circulatory system. In one embodiment, a radially outward force 720 is sufficient to maintain the position of the valve 29 and the docking station 10 within the circulation system.

[0087] In one exemplary embodiment, the frame 1500 of the docking station 10 is made of an elastic or superelastic material or a metal. One such metal is Nitinol. If the frame 1500 of the docking station 10 is made of a lattice of metal compression material, the body can have spring properties. Referring to Figure 7C, like a spring, when the frame 1500 of the docking station 10, as shown in Figures 24 and 25, is unconstrained and can be relaxed to its maximum diameter, the frame of the docking station exerts little or no radially outward force. As the frame 1500 of the docking station 10 is compressed, like a spring, the radially outward force exerted by the docking station increases. As shown in Figure 7C, in one exemplary embodiment, the relationship between the radially outward force of the docking station frame 1500 and the expanded diameter of the docking station is nonlinear, but it can also be linear. In the example shown in Figure 7C, curve 750 shows the relationship between the radially outward force acting on the docking station 10 and the compressed diameter of the docking station. In region 752, curve 750 has a small slope. In this region 752, the radially outward force is small and changes only slightly. In one 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, curve 750 has a larger slope. In this region 754, the radially outward force increases significantly as the docking station is compressed. In one exemplary embodiment, the stent body is constructed such that both the largest vessel 2300 (Figure 24) and the smallest vessel 2302 (Figure 25) housed in the docking station 10 are in region 752 with a small slope. This ensures that the sealing portion 710 applies only small radially outward forces to the inner surface 416 of the circulation system over a wide diameter.

[0088] Figures 26A–26C show the docking station 10 of Figure 18 embedded in the pulmonary artery. Figure 26A shows the contour of the docking station 10 embedded in the pulmonary artery PA. Figure 26B shows the contour of the docking station 10 embedded in the pulmonary artery PA with the schematically shown valve 29 loaded or deployed within the docking station 10. Figure 26C shows the docking station 10 and valve 29 as shown in Figure 22, embedded in the pulmonary artery PA. As mentioned with respect to Figures 2A–2E and 3A–3D, the shape of the pulmonary artery can vary considerably along its length. In one 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 bifurcation or branch of the pulmonary artery. However, the docking station 10 is often positioned so that its end 14 extends into the pulmonary artery bifurcation 210. If it is conceivable that the docking station 10 extends into the pulmonary artery bifurcation, the docking station 10 may have a blood permeable portion 1400 (for example, as shown in Figure 21).

[0089] 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 Figure 27 shows only one of many possible configurations. In the example shown by Figure 27, the docking station 10 has a relatively wide proximal inlet end 12 and a distal outlet end 14, and a long, narrow portion 2716. The valve seat 18 and sealing portion 410 can be located anywhere along the length of the long, narrow portion 2716. In the example shown by Figure 27, the frame 2700 of the docking station 10 is preferably a stent composed of a plurality of metal compression members 1502 forming a cell 1504. The frame 2700 or portion of the frame can optionally be covered with an impermeable material 21 (for example, as shown in Figure 18).

[0090] Figure 27 shows the frame 2700 and sealing portion 410 in an unrestrained extended state / configuration or a post-deployment configuration. In this exemplary embodiment, the retaining portion 414 comprises ends 1510 of a metal compression member 1502 at its proximal end 12 and distal end 14. The sealing portion 410 may be a separate component disposed around the frame 2700 between the retaining portions 414. In the unrestrained state, the retaining portions 414 extend substantially radially outward and may be radially outward of the sealing portion 410.

[0091] The docking station 10 shown in Figure 27 may be made from a highly elastic or adaptable material to accommodate large variations in anatomical structure. For example, the docking station may be made from a highly flexible metal (e.g., the frame in the example in Figure 27), as well as from fabric and / or open-cell foam (e.g., the sealing portion in the example in Figure 27). An example of a highly elastic metal is nitinol, but other metals and highly elastic or adaptable non-metallic materials can be used. An example of an open-cell foam that can be used is a biocompatible foam such as polyurethane foam (e.g., available from Biometrix, Rockville, MD). In one embodiment, the foam forming the sealing portion may also form a valve seat on its inner surface.

[0092] Continuing to refer to Figure 27, the frame 2700 and / or a separate sealing portion 410 may include an optional band 20 to form a non-expandable or substantially non-expandable valve seat 18. In another exemplary embodiment, the frame 2700 may be configured to be substantially non-expandable in the area of ​​the valve seat 18 without the use of a band 20. The optional band 20 reinforces the frame 2700 and / or the sealing portion, making the valve seat relatively non-expandable.

[0093] Any band 20 can be of a wide variety of different forms, can be made from a wide variety of different materials, and can be the same as or similar to the bands considered elsewhere in this disclosure. The band 20 can be made from PET, one or more sutures, fabric, metal, polymer, biocompatible tape, or other relatively non-expandable material known in the art that is sufficient to maintain the shape of the valve seat 18 and hold the valve 29 in place. The band can extend around the outside of the stent, or it can be an integral part of it, such as when the fabric or other material is woven into or through the cells of the stent. The band 20 can be narrow, such as the suture band in Figure 18, or wide, as indicated by the dashed lines in Figure 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 a particular valve 29 fixed within the valve seat 18, and may differ from the example above.

[0094] Figures 28 and 29 show a modified docking station 10 shown in Figure 27, in which the length is expandable. As mentioned above, the lengths of the pulmonary artery PA and other anatomical structures of the circulatory system can vary considerably from patient to patient. Referring to Figure 29, in one exemplary embodiment, the length of the docking station 10 is adjustable, as indicated by arrow 1100. The length may be adjusted in a wide variety of different ways, for example, by any of the methods described elsewhere in this disclosure. In the example shown in Figures 28 and 29, the docking station 10 includes a first half 1102 and a second half 1104. The second half 1104 can be inserted into or "fitted" into the first half 1102. The length of the docking station 10 is determined by the amount of insertion or "fitting".

[0095] In one exemplary embodiment, the length of the docking station 10 is adjusted within the pulmonary artery PA by first deploying the first half 1102 of the docking station 10 within the pulmonary artery. For example, the first half 1102 may be positioned and expanded so that its distal end 1106 aligns with or extends to some extent beyond a branch of the pulmonary artery. After the first half 1102 has been expanded within the pulmonary artery, a compressed second half 1104 is positioned so that its distal end 1110 aligns with the proximal end 1108 of the first half 1102. The position of the second half 1104 is selected so that the sealing portion 410 and the retaining portion 414 contact the pulmonary artery and set the position of the docking station 10 within the pulmonary artery. Once properly positioned, the second half 1104 is expanded. The distal end 1110 of the second half 1104 frictionally engages with the proximal end 1108 of the first half to secure the two halves 1102 and 1104 together. In one embodiment, locks, latching mechanisms, sutures, crosses, links, and / or other mounting devices / mechanisms may be used (additionally or alternatively) to secure the two halves together.

[0096] In the example shown in Figures 28 and 29, the valve seat 18 and sealing portion 410 are located on the first half 1102 of the docking station 10. However, in other embodiments, the valve seat 18 and / or sealing portion 410 may be located on the second half 1104, or at different positions on the first half and / or the second half.

[0097] Figures 30 and 31A show the docking station 10 of Figure 27 in Figures 28 and 29 embedded in the circulatory system, such as the pulmonary artery PA. The sealing portion 410 provides a seal between the docking station 10 and the inner surface 416 of the pulmonary artery PA. In the example of Figures 30 and 31A, the sealing portion 410 is an expandable material, such as expandable open-cell foam, on the frame 2700. In one exemplary embodiment, the sealing portion 410 coincides with or at least overlaps with the valve seat 18. If the sealing portion 410 does not overlap with the valve seat 18, the impermeable material 21 may be provided on a portion of the frame (for example, 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). Regardless of whether the sealing portion 410 overlaps with the valve seat 10 or whether an impermeable material is provided from the sealing portion 410 to the valve seat 18, all blood flowing in the inflow direction 12 toward the outflow direction 14 is directed toward the valve seat 18 (and toward the valve 29 after it has been loaded or deployed onto the valve seat).

[0098] In one exemplary embodiment of the docking station 10, at least the outflow portion 14 of the frame 2700 is relatively open. Referring to Figure 31A, this allows the docking station 10 to be positioned high within the pulmonary artery without restricting blood flow. For example, the open cell 1504 may extend into a branch or bifurcation of the pulmonary artery, but not obstruct or significantly obstruct blood flow beyond the branch. The open cell 1504 allows blood to flow through the frame 1500, as indicated by arrow 3132 in Figure 31A.

[0099] In the example shown in Figures 30 and 31A, the docking station 10 is secured within the pulmonary artery PA by extending one or more of the retaining portions 414 radially outward into regions 210, 212 of the pulmonary artery PA, where the inner surface 416 also extends outward. For example, the retaining portion 414 may be configured to extend radially outward into the pulmonary artery bifurcation 210 and / or the opening 212 of the pulmonary artery to the right ventricle RV. In one exemplary embodiment, the docking station 10 can be an adjustable docking station. For example, the docking station 10 can be a nesting docking station as shown in Figure 28, where a first portion 1102 is positioned such that the retaining portion 414 extends radially outward into the pulmonary artery bifurcation 210. The second portion 1104 can then be positioned within the first portion 1102 such that its retaining portion 414 coincides with the opening of the pulmonary artery or another outwardly extending region of the pulmonary artery. Once in place, the second portion 1104 can be expanded to fix the second compartment 1104 to the first compartment 1102, and the second compartment can be fixed to the pulmonary artery by the opening 212 or other outwardly extending region.

[0100] Referring to Figure 31B, the valve seat 18 serves as a support surface for loading or deploying the valve 29 within the docking station 10. The valve may be loaded or deployed onto the valve seat using steps disclosed in this or another part of the present disclosure. The fixing / retaining portion 414 retains the docking station 10 in its embedded or deployed part / position within the circulating system. After the docking station 10 is deployed, the valve 29 can be introduced into the valve seat 18 of the docking station 10 in a compressed form. The valve 29 expands within the docking station so that it can engage with the valve seat 18. The valve 29 can be delivered to the part of the docking station by conventional means, such as by ballooning or mechanical expansion, or by self-expansion. Once expanded, the valve 29 fits into the valve seat of the docking station 10.

[0101] Referring to Figure 32A, the docking station shown in Figure 18 is located within the pulmonary artery PA of the heart H. Figure 32B shows a comprehensively depicted valve 29 located within the docking station 10 shown in Figure 32A. In Figures 32A and 32B, the heart is in systole. Figure 33A is a magnified representation of the docking station 10 and valve 29 in the pulmonary artery in Figure 32B. When the heart is in systole, the valve 29 is open. Blood flows from the right ventricle RV through the pulmonary artery PA, docking station 10, and valve 29, as indicated by arrow 3202. Figure 33B shows space 3208 representing the open valve 29 when the heart is in systole. For simplicity of the drawing, Figure 33B does not show the interface between the docking station 10 and the pulmonary artery. The oblique lines in Figure 33B indicate blood flow through the open valve. In one exemplary embodiment, the seal 410 prevents blood from flowing between the pulmonary artery PA and the docking station 10, and the valve 29 is housed in the valve seat 18 of the docking station 10 to prevent blood from flowing between the docking station 10 and the valve 29. In this example, blood flows, or can flow, only through the valve 29 when the heart is in systole.

[0102] Figure 34 shows the valve 29, docking station 10, and heart H as shown in Figure 32B when the heart is in diastole. Referring to Figure 34, when the heart is in diastole, valve 29 is closed. Figure 35A is a magnified representation of the docking station 10 and valve 29 within the pulmonary artery 29 in Figure 34. Blood flow within the pulmonary artery PA (i.e., within the pulmonary artery branch 210) above valve 29 is obstructed by the closure of valve 29, obstructing blood flow as indicated by arrow 3400. The solid region 3512 in Figure 35B represents the closed state of valve 29 when the heart is in diastole.

[0103] Referring to Figure 33A, the radially outward force 720 of the fixing / retaining portion 414 to the inner surface 416 is substantially less than the radially outward force 710 applied to the valve seat 18 by the valve 29. For example, the radially outward sealing force 720 can be less than half, less than one-third, less than one-quarter, less than one-eighth, or even less than one-tenth of the radially outward force 710 applied by the valve.

[0104] Referring to Figures 33A and 35A, in one exemplary embodiment, the radially outward force 720 of the retaining portion 414 is insufficient on its own to retain the position of the valve 29 and the docking station 10 within the circulatory system. Rather, the pressure of the blood 3208 is used to reinforce the retention of the retaining portion 414 against the inner surface 416. Referring again to Figure 33A, when the heart is in systole, the valve 29 is open and blood flows through the valve as indicated by arrow 3202. Since the valve 29 is open and blood is flowing through it, the pressure P exerted by the blood on the docking station 10 and the valve 29 is low, as indicated by the small arrow P shown in Figure 33A. Although the pressure P is low, it presses the docking station and its upper retaining portion 414 against the surface 416 in approximately the direction indicated by arrow F (the small F represents a relatively small force). The blood flow-assisted force F applied to the surface 416 by the retaining portion 414 prevents the docking station 10 and valve 29 from moving in the direction of blood flow 3302 during the systole of the heart H.

[0105] Referring to Figure 35A, when the heart is in diastole, valve 29 is closed and blood flow is obstructed as indicated by arrow 3400. Since valve 29 is closed and valve 29 and docking station 10 obstruct blood flow, the pressure P exerted by the blood on docking station 10 and valve 29 is high, as indicated by the large arrow P in Figure 35A. This high pressure P presses the lower retaining portion 414 against surface 416 in approximately the direction indicated by the large arrow F (large F represents a relatively large force). This blood flow-assisted force F 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.

[0106] Referring to Figures 33A and 35A, the forces applied by the upper and lower restraint portions 414 are determined by the amount of pressure exerted on the valve 29 and docking station 10 by the blood, so the forces applied to the surface 416 are automatically proportional. That is, the force with which the upper restraint portion presses against the surface 416 when the heart is in systole is weaker than the force with which the lower restraint portion presses against the 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.

[0107] A method of treating a patient (e.g., a method of treating cardiac valve dysfunction / regurgitation / other) may include a variety of steps, such as introducing and deploying a docking station to a desired location / treatment area, and introducing and deploying a valve within the docking station. For example, Figure 36A shows the docking station shown in Figure 18, deployed by a catheter 3600. The docking station 10 can be positioned and deployed in a wide variety of different ways. Access may be obtained through the femoral vein, or access may be percutaneous. In general, any vascular route leading to the pulmonary artery may be used. In one exemplary embodiment, a guidewire and subsequently a catheter 3600 are advanced into the pulmonary artery PA using the femoral vein, inferior vena cava, tricuspid valve, and right ventricular RV. The docking station 10 can be positioned within the right ventricular outflow tract / pulmonary artery PA to create a landing area for an artificial conduit and valve (e.g., a transcatheter cardiac valve) 29.

[0108] Referring to Figure 36B, the docking station shown in Figure 18 is located within the pulmonary artery (PA) of the heart H. Figure 36C shows the valve 29 located within the docking station 10 shown in Figure 32A. In the examples shown in Figures 36C, 37A, 38, 39A, and 39B, the valve 29 is depicted as a SAPIEN 3 THV provided by Edwards Lifesciences, although various other valves may also be used. In Figures 36A–36C, the heart is in systole. Figure 37A is a magnified representation of the docking station 10 and valve 29 within the pulmonary artery 29 in Figure 36C. When the heart is in systole, the valve (e.g., Sapien 3 valve) is open. Blood flows from the right ventricle RV through the pulmonary artery PA, docking station 10, and valve, as indicated by arrow 3202. Figure 37B shows space 3208 representing the valve being open when the heart is in systole. Figure 37B does not show the interface between the docking station 10 and the pulmonary artery for the sake of simplicity. The oblique lines in Figure 37B indicate blood flow through the valve. In one exemplary embodiment, a seal 410 prevents blood from flowing between the pulmonary artery PA and the docking station 10, and a valve is housed in the valve seat 18 of the docking station 10 to prevent blood from flowing between the docking station 10 and the valve. In this example, blood flows through the valve only, or can flow, when the heart is in systole.

[0109] Figure 38 shows the valve 29, docking station 10, and heart H as shown in Figure 36C, when the heart is in diastole. Referring to Figure 38, when the heart is in diastole, valve 29 is closed. Figure 39A is a magnified representation of the docking station 10 and valve (e.g., Sapien 3 valve) within the pulmonary artery 29 in Figure 38. Blood flow within the pulmonary artery PA (i.e., within the pulmonary artery branch 210) above valve 29 is obstructed by the closure of valve 29, obstructing blood flow as indicated by arrow 3400. The solid region 3512 in Figure 39B represents the closed state of valve 29 when the heart is in diastole.

[0110] Referring to Figure 39A, the radially outward force 720 of the fixing / retaining portion 414 against the inner surface 416 is substantially less than the radially outward force 710 applied to the valve seat 18 by the valve (e.g., a Sapien 3 valve). For example, the radially outward sealing force 720 can be less than half, less than one-third, less than one-quarter, less than one-eighth, or even less than one-tenth of the radially outward force 710 applied by the valve. A 29 mm Sapien 3 valve typically applies a radially outward force 710 of about 42 Newtons. In one embodiment, the radially outward force of the deployed docking station, or one or more parts of the deployed docking station, as described herein may be about 4 to 16 Newtons, but other forces are also possible.

[0111] Figure 40A shows the docking station shown in Figure 27 or 28, deployed by catheter 3600. Referring to Figure 40B, the docking station shown in Figure 27 or 28 is deployed in the pulmonary artery PA of the heart H. Figure 40C shows the valve 29 deployed in the docking station 10 shown in Figure 40A. In the examples shown in Figures 36C, 37A, 38, 39A, and 39B, the valve 29 is depicted as a SAPIEN 3 THV provided by Edwards Lifesciences, but various other valves may also be used. In Figures 40A–40C, the heart is in systole. Figure 41A is a magnified representation of the docking station 10 and valve 29 in the pulmonary artery 29 of Figure 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. Figure 41B shows the space 3208 representing the open valve 29 when the heart is in systole. For simplicity of the drawing, Figure 41B does not show the interface between the docking station 10 and the pulmonary artery. The oblique lines in Figure 41B represent blood flow through the valve 29. In one exemplary embodiment, a seal 410 prevents blood from flowing between the pulmonary artery PA and the docking station 10, and the valve is housed in the valve seat 18 of the docking station 10, preventing blood from flowing between the docking station 10 and the valve 29. In this example, blood flows, or can flow, through the valve only when the heart is in systole.

[0112] Figure 42 shows the valve 29, docking station 10, and heart H as shown in Figure 40C, when the heart is in diastole. Referring to Figure 42, when the heart is in diastole, valve 29 is closed. Figure 43A is a magnified representation of the docking station 10 and valve 29 within the pulmonary artery 29 in Figure 42. Blood flow within the pulmonary artery PA (i.e., within the pulmonary artery branch 210) above valve 29 is obstructed by the closure of valve 29, obstructing blood flow as indicated by arrow 3400. The solid region 3512 in Figure 43B represents the closed state of valve 29 when the heart is in diastole.

[0113] Referring to Figure 43A, the docking station 10 is secured within the pulmonary artery PA by extending one or more retaining / fixing portions 414 radially outward into the regions 210, 212 of the pulmonary artery PA, where the inner surface 416 also extends outward. For example, the retaining portions 414 may be configured to extend radially outward into the pulmonary artery bifurcation 210 and / or the opening 212 of the pulmonary artery to the right ventricle RV. In one exemplary embodiment, the docking station 10 may be an adjustable docking station and / or a docking station with multiple components. For example, the docking station 10 may be a nested docking station as shown in Figure 28, where a first portion 1102 can be deployed so that the retaining portion 414 extends radially outward into the pulmonary artery bifurcation 210, and a second portion 1104 can be positioned within the first portion 1102 so that its retaining portion 414 coincides with the opening 212 of the pulmonary artery. The retention portion 414 extends into regions 210 and 212, thereby positioning the docking station 10 within the pulmonary artery PA and helping to prevent the pressure P shown in Figure 43A from displacing the docking station.

[0114] The valve 29 used with the docking station 10 can take on a wide variety of different forms. In one exemplary embodiment, the valve 29 may be configured to be implanted in the heart H via a catheter. For example, the valve 29 may be expandable and foldable to facilitate transcatheter application within the heart. However, in other embodiments, the valve 29 may be configured for surgical application. Similarly, the docking station described herein may be deployed using transcatheter application / placement or surgical application / placement.

[0115] Figures 44–48 show some examples of the many valves or valve configurations that can be used. Any valve type may be used, and some valves conventionally applied surgically may be modified for transcatheter implantation. Figure 44 shows an expandable valve 29 for transcatheter implantation, illustrated and described in U.S. Patent No. 8,002,825, which is incorporated herein by reference in whole. An example of a trilobe valve is illustrated and described in International Patent Application Publication WO2000 / 42950, ​​which is incorporated herein by reference in whole. Another example of a trilobe valve is illustrated and described in U.S. Patent No. 5,928,281, which is incorporated herein by reference in whole. Another example of a trilobe valve is illustrated and described in U.S. Patent No. 6,558,418, which is incorporated herein by reference in whole. Figures 45–47 show an exemplary embodiment of an expandable trilobe valve 29, such as Edwards' SAPIEN transcatheter heart valve. Referring to Figure 45, in one exemplary embodiment, the valve 29 comprises a frame 712 housing a tri-lobe valve 4500 (see Figure 46) compressed within the frame 712. Figure 46 shows the expanded frame 712 and the valve 29 in the open position. Figure 47 shows the expanded frame 712 and the valve 29 in the closed position. Figures 48A, 48B, and 48C show examples of expandable valves 29 illustrated and described in U.S. Patent No. 6,540,782, which is incorporated herein by whole reference. Another example of a valve is illustrated and described in U.S. Patent No. 3,365,728, which is incorporated herein by whole reference. Yet another example of a valve is illustrated and described in U.S. Patent No. 3,824,629, which is incorporated herein by whole reference. Yet another example of a valve is illustrated and described in U.S. Patent No. 5,814,099, which is incorporated herein by whole reference. Any of these or other valves may be used as valve 29 in the various embodiments disclosed herein.

[0116] Figures 49A, 49B, and 50A–50D show the distal portion of an exemplary embodiment of a catheter 3600 for delivering and deploying a docking station 10. The catheter 3600 can be in a wide variety of different forms. In the illustrated example, the catheter 3600 includes an outer tube / sleeve 4910, an inner tube / sleeve 4912, a docking station connector 4914 connected to the inner tube 4912, and an elongated nose cone 28 connected to the docking station connector 4914 by a connecting tube 4916.

[0117] The docking station 10 can be positioned within the outer tube / sleeve 4910 (see Figure 49B). The elongated leg 5000 can connect the docking station 10 to the docking station connector 4914 (see Figure 49B). The elongated leg 5000 can be a retention portion longer than the rest of the retention portion 414. The catheter 3600 can be advanced over the guidewire 5002 to position the docking station 10 at the delivery site.

[0118] Referring to Figures 50A to 50D, the outer tube 4910 is gradually withdrawn relative to the inner tube 4912, the docking station connector 4914, and the elongated nose cone 28 to deploy the docking station 10. In Figure 50A, the docking station 10 begins to extend from the outer tube 4910. In Figure 50B, the distal end 14 of the docking station 10 extends from the outer tube 4910. In Figure 50C, the docking station 10 extends outside the outer tube, but the elongated leg 5000 remains retained within the outer tube 4910 by the docking station connector 4914. In Figure 50D, the docking station connector 4914 extends from the outer tube 4910, releasing the leg 5000, thereby fully deploying the docking station. Similar steps may be used while deploying the docking station within the circulatory system, and the docking station may be deployed in a similar manner.

[0119] Figures 51 and 54 show 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 the catheter, 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, with the narrower distal end of the cone being relatively flexible. In a 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 for accommodating the guidewire 5002. In one embodiment, the cone becomes progressively stiffer as the diameter of the nose cone 100 increases from the narrower distal end to the wider proximal end. This may be due to an increase in thickness, and / or the nose cone may be constructed from different materials having different durometers. Optionally, to prevent abrupt changes in stiffness, the stiffness at the point where the nose cone connects to the outer tube 4910 may be approximately the same as the stiffness of the outer tube 4910. In the examples shown in Figures 51 and 54, the elongated distal end 5110 of the nose cone 28 is the same. In one embodiment, the taper of the nose cone 28 extends only over the entire length of the nose cone 28 from end to end, or only a portion thereof. To form the taper, the outer diameter of the nose cone 28 may increase from distal to proximal. 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.

[0120] In one exemplary embodiment, the longer distal end 5110 of the nose cone 28 helps to navigate around bends or curves in the patient's vascular system. As the length of the nose cone 28 increases, more of the tip passes around the bend, resulting in a "follow-the-leader" effect together with the rest of the nose cone.

[0121] In the example shown in Figure 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 snag on the docking station 10 implanted in the heart when the delivery catheter is retrieved. Thus, the proximal base portion 5112 makes it easier to remove the delivery system. Referring to Figure 53, as the angled portion 5308 (or “inclined”) of the base portion 5112 is withdrawn into the outer tube 4910, the inclined portion 5308 enters the delivery catheter first, and then the shelf portion 5310. When the nose cone 28 engages with the outer sleeve / tube 4910, the inner diameter of the outer sleeve rides up onto the inclined portion 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 may be slightly smaller than the diameter of the shelf section 5310 to ensure a tight fit.

[0122] In one non-limiting example, the shelf portion 5310 of the nose cone 28 fits snugly into the lumen or outer lumen of the catheter assembly 3600, which in one non-limiting example may have a diameter of approximately 0.2 inches or 0.1 to 0.4 inches. In one embodiment, the outer diameter of the largest portion of the nose cone 28 may be 0.27 inches or 0.2 to 0.4 inches, and the diameter at the distal tip of the nose cone may be 0.069 inches or 0.03 to 0.1 inches. Again, these dimensions are for illustrative purposes only. For example, the outer diameter or maximum outer diameter of the nose cone 28 may 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 may be the same as the outer diameter of the outer tube 4910, or the outer diameter of the nose cone 28 may be smaller (e.g., slightly smaller) than the outer diameter of the outer tube 4910.

[0123] In the example shown in Figure 54, the entire base or proximal end / part 5112 of the nose cone 28 is angled. The continuously angled proximal end 5112 does not snag on the docking station 10 implanted in the heart when the delivery catheter is retrieved. Thus, the base part 5112 makes it easier to remove the delivery system. Referring to Figure 55, the outer tube 4910 may include a bite portion 5500 that receives and bites with the continuously angled proximal end 5112.

[0124] In one non-limiting example, the continuously angled proximal end 5112 of the nose cone 28 fits snugly into the outer tube / sleeve 4910 (which may optionally be chamfered) of the catheter assembly 3600. The outer diameter or maximum outer diameter of the nose cone 28 may be larger (e.g., slightly larger) than the outer diameter of the outer tube 4910, the outer diameter of the nose cone 28 may be the same as the outer diameter of the outer tube 4910 as shown, or the outer diameter of the nose cone 28 may be smaller (e.g., slightly smaller) than the outer diameter of the outer tube 4910.

[0125] The docking station 10 can be connected to the catheter assembly or the docking station connector 4914 of the catheter assembly in a wide variety of different ways. For example, the docking station 10 can be connected to the catheter assembly using locks, locking mechanisms, sutures (e.g., one or more sutures that are releasably attached, tied, or braided through one or more parts of the docking station), interlock devices, combinations thereof, or other attachment mechanisms. Some of these connection or attachment mechanisms may be configured to allow the docking station to be withdrawn 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 cross-section or folded configuration, so that the docking station can be adjusted, removed, or replaced. Figures 56, 57, 57A, and 57B show some non-limiting examples of how the docking station 10 can be connected to the docking station connector 4914. As shown in Figures 50A to 50D, in an exemplary embodiment, the docking station 10 self-expands as it is pushed out of the outer tube. One strategy to control the expansion of the docking station 10 is to secure at least one end of the stent, such as the proximal end 12, to the docking station connector 4914. This strategy allows the distal end 14 of the stent to expand first without the proximal end expanding (see Figure 50B). Next, as the stent is moved forward relative to the outer tube 4910, the proximal end 12 disengages from the docking station connector 4914, allowing the proximal end 12 of the docking station to expand (see Figure 50D).

[0126] One way to achieve this strategy is to include one or more extensions 5000 on at least the proximal end of the stent 12. In the illustrated example, two extensions are included. However, any number of extensions 5000, such as two, three, or four, can be included. The extensions 5000 can be in a wide variety of different forms. The extensions 5000 can engage with the docking station connector 4914 within the outer tube 4910. In one exemplary embodiment, the docking station connector 4914 may engage with the inner surface 5600 of the extension 5000. In one exemplary embodiment, aside from the possible engagement between the inner surface 5600 of the extension 5000 (see Figure 57A) and the docking station connector 4914, when the distal portion of the catheter assembly and / or docking station has a straight or substantially straight configuration, the extension 5000 and the docking station connector 4914 are configured to limit the retaining engagement between them to two points, although they can similarly be configured to limit the retaining engagement to a different number of points, for example, 3 to 6 points. In one exemplary embodiment, when the distal portion of the catheter assembly and / or docking station has a straight or substantially straight configuration, the radially outward biasing force of the compressed extension prevents the inner surface 5600 of the extension 5000 from contacting 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 curvature of the catheter assembly 3600 and / or docking station. The extension 5000 may include a head 5636 having a side surface 5640 that extends away from the straight section 5638 at an angle β (see Figure 57A), such as 30 to 60 degrees. Such a head 5636 may be substantially triangular as shown, or the angled side surface 5640 may 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 may not be triangular and may function in the same shape as the triangular head shown.

[0127] The delivery catheter 3600 consistently bends and curves as it travels through the patient's body's vascular system. A head 5636 that transitions directly from the straight portion 5638 of the extension 5000 to a T-shape, curved T-shape, circular, or spherical shape will generally have more than two points of retaining contact with its holder (except for possible engagement between the inner surface 5600 of the extension 5000 (see Figure 17A) and the docking station connector 4914). Referring to Figures 57A and 57B, a head 5636 having sides 5640 extending 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 at only two points 5702, 5704. In the example shown by Figure 57A, the two points are the angle formed by the T-shaped recess 5710. As shown in Figure 57B, the extension 5000 may tilt as the catheter 3600 and docking station 10 move through the body during delivery. In one exemplary embodiment, this tilt may also result in contact at only two points between the extension 5000 and the docking station connector 4914, as shown in Figure 57B (excluding possible engagement between the inner surface 5600 of the extension 5000 (see Figure 17A) and the docking station connector 4914). Thus, the extension 5000 can tilt during delivery to increase the flexibility of the catheter 3600 in the area of ​​the docking station 10, while the two-point contact prevents coupling between the extension 5000 and the connector 4914.

[0128] Referring to Figures 56, 57, 57A, and 57B, the head 5636 engages with 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 out of the catheter relative to it (i.e., by withdrawing the outer tube / sleeve 4910 or by advancing the connector 4914 (see Figure 50D)). Referring to Figure 56, the outer tube / sleeve 4910 of the catheter 3600 can be positioned tightly on the connector 4914 such that the head 5636 is captured in the recess 5710 between the outer tube / sleeve 4910 and the body of the connector 4914. This capture within the recess 5710 holds the end of the docking station 10 as the docking station expands. In this way, the delivery of the docking station 10 is controlled.

[0129] Referring again to Figure 50D, at the end of the docking station 10's expansion, 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 engage with and disengage from each recess 5710 (see Figure 56).

[0130] In one embodiment, all extensions 5000 are the same length. When the connector is moved relatively out of the outer tube / sleeve 4910, the recesses 5710 are simultaneously moved relatively out of the outer sleeve 4910. Since all extensions 5000 are the same length, the recesses 5710, along with the heads 5636, all emerge from the delivery outer sleeve 4910 at the same time. As a result, the docking station heads 5636 are all moved radially outward and released at once.

[0131] In an alternative embodiment, the docking station 10 comprises extensions 5000 having a head 5636, but at least some of the extensions 5000 are longer than others. Thus, as the connector 4914 is gradually moved outward relative to the outer sleeve 4910, the shortest extensions 5000 are released first from their respective recesses 5710. Then, as the connector 4914 is moved further outward relative to the outer sleeve 4910, the longer 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 in the circulatory system to a delivery site or therapeutic area. Upon reaching the delivery site, the docking station 10 is deployed by moving the outer sleeve or tube 4910 toward the inner sleeve or tube 4912, as well as the attached connector 4914 and docking station 10 (see Figures 50A–50D). The outer sleeve 4910 can be moved relative to the inner sleeve 4912 in a wide variety of different ways. Figures 58–61 and 62–73 show examples of tools or handles 5800, 6200 that can be used, for example, to move the catheter 3600 in 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.

[0132] In the example shown in Figures 58 to 61, the handle 5800 includes a housing 5810, a drive member 5812, and a driven shaft 5814. In the illustrated example, the driven shaft 5814 moves linearly as indicated by arrow 5818 by rotating the drive member 5812 relative to the housing 5810 as indicated by arrow 5816. Referring to Figure 60, the inner sleeve 4912 is fixedly connected to the housing 5810 as indicated by arrow 6000, and the outer sleeve 4910 is fixedly connected to the driven shaft 5814 as indicated by arrow 6002. Therefore, by rotating the drive member 5812 in a first direction, the outer sleeve 4910 is withdrawn relative to the inner sleeve 4912, and by rotating the drive member 5812 in the opposite direction, the outer sleeve 4910 moves forward relative to the inner sleeve 4912.

[0133] In the example shown in Figures 58 to 61, the housing 5810 includes an annular recess 5820. The drive member 5812 includes an annular projection 5822. The annular projection 5822 fits into the annular recess to rotatably connect the drive member 5812 to the housing 5810. The drive member 5812 includes an engaging portion 5830 extending from the housing, which allows the user to rotate the drive member 5812 relative to the housing 5810.

[0134] In the examples shown in Figures 58 to 61, the housing 5810 includes a linear recess 5840 or groove (see Figure 59). The driven shaft 5814 includes a linear projection 5842. The linear projection 5842 fits into the linear recess 5840, slidably connecting the driven shaft 5814 to the housing 5810.

[0135] In the example shown in Figures 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 engages with the female thread 5850, operably connecting the drive member 5812 to the driven shaft 5814. That is, when the drive member 5812 is rotated relative to the housing 5810 as indicated by the arrow 5816, the rotation of the driven shaft 5814 is prevented by the linear projection 5842 that fits into the linear recess 5840. Therefore, as the drive member 5812 rotates within the housing 5810, the engagement of the male thread portion 5852 engages with the female thread 5850, causing the driven shaft 5814 to slide linearly along the linear recess 5840 (5818). 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 advance and retract relative to the inner shaft / tube 4912.

[0136] In the example shown in Figures 58 to 61, the outer shaft / tube 4910 is fixedly connected to a recess 5850 of the driven shaft 5814, and an optional seal 5852 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, to the proximal end of the housing 5810 as shown. The inner shaft / tube 4912 is fixedly connected to a recess 5860 of the Luer port 5862. The Luer port 5862 is configured to receive a guidewire 5002 (see Figure 49) extending through the inner shaft / tube 4912.

[0137] In the example shown in Figures 62-67, the handle 6200 includes a housing 6210, a drive wheel 6212, and a driven member 6214. In the illustrated example, the driven member 6214 moves linearly as indicated by arrow 6218 by rotating the drive wheel 6212 relative to the housing 6210 as indicated by arrow 6216 (compare the position of the driven member 6214 in Figures 64A and 64B). Referring to Figure 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 a first direction, the outer sleeve 4910 is pulled back relative to the inner sleeve 4912, and by rotating the drive wheel 6212 in the opposite direction, the outer sleeve / tube 4910 moves forward relative to the inner sleeve / tube 4912. In the various embodiments shown in Figures 58 to 73, the inner sleeve / tube 4912 is illustrated 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 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 may be movable relative to the handle or the proximal end of the handle, and the outer sleeve / tube 4910 may 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 may be configured to be movable relative to each other and relative to the handle or the proximal end of the handle.

[0138] In the example shown in Figures 62 to 67, the housing rotatably receives the axle 6822 of the drive wheel 6212, thereby rotatably connecting the drive wheel to the housing 6210. The drive wheel 6212 includes an engaging portion 6230 extending from the housing 6210, which allows the user to rotate the drive wheel 6212 relative to the housing 6210.

[0139] In the example shown in Figures 62 to 67, the housing 6210 includes a linear projection 6240 (see Figure 66). The driven member 6214 includes a linear groove 6242 (see Figures 62 and 66) into which the projection 6240 fits, slidably connecting the driven member 6214 to the housing 6210.

[0140] In the example shown in Figures 62 to 67, the drive member 6212 includes a pinion gear 6250. The driven member 6214 includes a rack gear portion 6252. The pinion gear 6250 meshes with the rack gear portion 6252 to operably connect the drive wheel 6212 to the driven member 6214. That is, when the drive wheel 621 rotates relative to the housing 6210 as indicated by arrow 6216, the driven member 6214 slides relative to the housing 6210 due to the linear projection 6240 that fits into the linear recess 6242. Therefore, the rotation of the drive member 6212 relative to the housing 6210 drives the pinion gear 6250 to drive the rack gear portion 6252, causing the driven member 6214 to slide linearly relative to the housing 6210 (6218). Since the outer shaft / tube 4910 is connected to the driven 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 advance and retract relative to the inner shaft / tube 4912.

[0141] In the example shown in Figures 62 to 67, the outer shaft / tube 4910 is fixedly connected to a support portion 6250 extending from the rack gear portion 6252 of the driven 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 driven 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 to the recess 5860 of the Luer port 5862. The Luer port 5862 is configured to receive a guide wire 5002 (see Figure 49) extending through the inner shaft / tube 4912.

[0142] Referring to Figure 63, in an exemplary embodiment, the catheter 3600 may be flushed by applying fluid to the inner tube 4912, such as through the Luer port 5862 into the inner tube. As described above, the delivery catheter 3600 includes an outer lumen formed in the outer tube / sleeve 4910 and an inner lumen formed in the inner tube / sleeve 4912, the inner lumen and the inner tube 4912 being coaxial in the longitudinal direction with the outer lumen and the outer tube 4910. The annular lumen / gap / space 6348 between the inner tube 4912 and the outer tube 4910 may be provided, for example, by the need to provide space for a bent stent to advance through the catheter 3600. This gap / space 6348 may initially be filled with air, which can later be drained and replaced with a liquid, such as saline solution. In this way, flushing can be performed using the various handle embodiments shown in Figures 58 to 73.

[0143] In one exemplary embodiment, a fluid, such as saline solution or another suitable fluid, flows from the Luer port 5862 through the lumen of the inner tube 4912, as indicated by arrow 6360. In this embodiment, the inner tube 4912 comprises one or more wash apertures 6354. The fluid flows through the interior of the inner tube 4912, exits the aperture 6354, as indicated by arrow 6370, and enters the gap / space 6348.

[0144] 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 engaged and disengaged from the distal end of the outer tube 4910, allowing air to flow out of the outer tube and also from the catheter 3600. The fluid also flows through the lumen of the inner tube 4912, pushing air out of the lumen. In an exemplary embodiment, the air is expelled from the lumen through an opening 6390 at the end of the nose cone 28 (see Figures 49A and 49B). This flushing procedure is performed before the delivery catheter 3600 is introduced into the body. The device and method of this approach save space compared to, for example, providing a side port on the outer tube 4910 for introducing flushing fluid into the delivery catheter assembly or the gap / space 6348.

[0145] Referring to Figures 68 to 73, in an exemplary embodiment, the handle 6200 shown in Figures 62 to 67 may be equipped with a ratchet mechanism 6800. The ratchet mechanism 6800 can take on a wide variety of different forms and can be used with the handle 6200 in various different ways. In an exemplary embodiment, the ratchet mechanism 6800 is used while “re-capturing” the docking station 10 and pulling it back into the delivery catheter 3600. The force required to re-capture the docking station may be considerable. Therefore, the ratchet mechanism 6800 may be configured such that, when the ratchet mechanism is engaged (Figures 68 to 71), the drive wheel 6212 can only be rotated in the direction of pulling the docking station 10 back into the outer tube / sleeve 4910. That is, the spring force of the docking station 10 is prevented by the ratchet mechanism 6800 from pulling the docking station out of the outer tube again. For example, if the operator releases the drive wheel 6212, the docking station 10 can be continuously re-captured without causing the docking station to move backward.

[0146] Referring to Figures 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. Figures 68–71 show the engaged state in which a ratchet arm 6892 engages with projection 6810 to position the drive wheel 6212 so as to allow it to rotate in one direction and prevent it from pivoting in the opposite direction. For example, the ratchet arm 6892 may be configured to ride up onto the inclined surface 6814, allowing the drive wheel 6212 to move in the withdrawal direction 6850. For example, the ratchet arm 6892 may be bent to ride up onto the inclined surface 6814. The stop surface 6812 engages the ratchet arm 6892 and is configured to prevent the drive wheel from rotating in the forward direction 6852. For example, the stopping surface 6812 may be substantially perpendicular to the side surface 6870 of the drive wheel 6212 to prevent the ratchet arm from moving over the projection 6810.

[0147] Figures 72 and 73 show the ratchet mechanism 6800 with the ratchet arm 6892 disengaged from the projection 6810. This allows the drive wheel 6212 to pivot in either direction. For example, the ratchet mechanism 6800 may be positioned in a disengaged state so that the drive wheel 6212 can pivot in either direction when the docking station 10 is deployed.

[0148] In ratchet systems, it is common to place the ratchet teeth on the outer circumference of the wheel. Placing the teeth on the surface of the wheel reduces the wheel's diameter and saves space. This also allows the outer circumference of the wheel to be used as a thumb grip, rather than having a second wheel engaged with a first wheel for gripping. The wheel itself can also be made thinner. The wheel may be made of any suitable material, such as polycarbonate.

[0149] Referring to Figure 71, in one embodiment, the ratchet arm 6892 can be bent so that a portion of the arm rests on a stabilizing bar 194 extending from the housing wall or is otherwise positioned within the housing, in order to prevent the arm 6892 from twisting when a force is applied to the arm due to the movement of the wheel.

[0150] The above primarily describes embodiments of self-expanding docking stations. However, the docking stations and / or delivery devices illustrated and described herein can be modified for the delivery of balloon-expanding and / or mechanically expandable docking devices within the scope of this disclosure. That is, delivery of balloon-expanding and / or mechanically expandable docking stations to implantation sites can be performed percutaneously using modified delivery devices of this disclosure. In general terms, this includes providing transcatheter assemblies which may include delivery sheaths and / or additional sheaths as described above. In the case of balloon-expanding docking stations, the device generally further includes a delivery catheter, a balloon catheter, and / or a guidewire. The delivery catheter used in balloon-expanding delivery devices may define a lumen in which the balloon catheter is received. The balloon catheter then defines a lumen in which the guidewire is slidably disposed. Furthermore, the balloon catheter includes a balloon fluid-connected to an inflation source. With the docking station mounted on the balloon, the transcatheter assembly is delivered through the patient's percutaneous orifice via the delivery device. Once the docking station is properly positioned, the balloon catheter is manipulated to inflate the balloon, thereby transitioning the docking station into its expanded configuration.

[0151] Considering the many possible embodiments to which the principles of the disclosed invention may be applied, it should be recognized that the illustrated embodiments are merely preferred examples of the invention and should not be understood as limiting the scope of the invention. All combinations or subordinate combinations of the features of the exemplary embodiments described above are recalled by this application. The scope of the invention is defined by the following claims. Accordingly, everything that falls within the scope and spirit of these claims is claimed as the inventors' invention. [Explanation of symbols]

[0152] 10 docking stations 12 Proximal end 14. Distal end 18 valve seats 20 bands 21 Impermeable materials 29 valves 194 Stabilization Cover 210 areas 212 areas 410 Sealing part 414 Retention part 416 Inner surface 510 External surface 512 Inner surface 602 Direction of blood flow 608 Space 710 Radial outward force 712 frames 720 Radial outward force 722 Radial outward force 750 curve 752 areas 754 areas 760 Pulmonary artery branch 900 Arrow 912 Solid area 1100 Arrow 1102 First half 1104 Second half 1106 Distal end 1108 Proximal end 1110 Distal end 1400 Transparent part 1402 Transparent part 1404 Opaque part 1420 area 1500 frames 1502 Metal Compression Material 1504 cells 1510 End 2000 parts 2020 Arrow 2100 area 2130 area 2132 Arrow 2300 Vascular 2302 Vascular 2700 frames 2716 Narrow section 3132 Arrow 3202 Arrow 3208 Space 3400 Arrow 3512 Solid area 3600 catheters 4500 Mitsuba dialect 4910 Outer tube 4912 Inner tube 4914 Docking Station Connector 4916 Connecting Tube 5000 extension 5002 Guidewire 5110 Distal end 5112 Base part 5200 lumen 5308 Slope 5310 Shelf 5500 (food portion) 5600 Inner 5636 Head 5638 Straight section 5640 Side view 5702 points 5704 points 5710 Depression 5800 handle 5810 Housing 5812 Drive Member 5814 Passed member 5816 Arrow 5818 Arrow 5820 Depression 5822 Protrusion 5830 Engagement part 5840 Depression 5842 Protrusion 5850 Female thread 5852 Male screw 5860 Depression 5862 Lureport 6000 arrows 6002 Arrow 6200 Handle 6210 Housing 6212 Drive Member 6214 Passed member 6216 Arrow 6218 Arrow 6230 Engagement part 6240 Protrusion 6242 depression 6250 Pinion Gear 6252 Rack gear section 6348 Gap 6354 Aperture 6360 Arrow 6370 Arrow 6390 Opening 6800 Ratchet Mechanism 6810 Protrusion 6812 Stopping surface 6814 Slope 6822 Axle 6850 Withdrawal direction 6852 Forward direction 6870 Side view 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. Lumbar region and, A sealing portion connected to the waist, which is expandable radially outward from the waist, and which, in the deployed position, provides a seal to the inner surface of the circulating system over the range of its expanded size, A retaining portion connected to the sealing portion, which is extendable radially outward to engage with the inner surface of the circulating system at the deployment position in order to hold the docking station in the deployment position within the circulating system, In an expandable docking station frame equipped with, When the expandable docking station frame is expanded and in an unrestrained state, the sealing portion and the retaining portion are joined by concave contours radially inward of the first outermost diameter of the sealing portion and the second outermost diameter of the retaining portion, The second outermost diameter of the retaining portion is defined by the flared axial end of the expandable docking station frame, An expandable docking station frame wherein the sealing portion defines a convex contour, and at the deployment position, the convex contour extends radially outward to contact the inner surface of the circulation system.

2. The expandable docking station frame according to claim 1, wherein the retaining portion is configured to engage with a second position on the inner surface of the circulating system at an angle of 30° to 60° from the perpendicular to the inner surface of the circulating system.

3. The expandable docking station frame according to claim 1, wherein the second outermost diameter of the retaining portion is larger than the first outermost diameter of the sealing portion.

4. The extended docking station frame according to claim 1, wherein the concave contour portion is located radially outward of the waist portion.

5. The expandable docking station frame according to claim 1, wherein the expandable docking station frame is composed of a grid of compressed metal material.

6. The expandable docking station frame according to claim 5, wherein the grid of the metal compression material defines a plurality of rhombic cells.

7. The expandable docking station frame according to claim 5, wherein the grid of the metal compression material defines a first row of cells located on the first side of the waist, a second row of cells aligned with the waist, and a third row of cells located on the opposite side of the first side of the waist.

8. The expandable docking station frame according to claim 7, further comprising an opaque cover disposed on at least the first cell row and the second cell row.

9. The extended docking station frame according to claim 8, wherein the third cell row is covered with an opaque cover.

10. The extended docking station frame according to claim 8, wherein the third cell row is not covered with an opaque cover.

11. The expandable docking station frame according to claim 8, wherein the sealing portion is defined by the first cell row and the opaque cover.

12. The extended docking station frame according to claim 7, wherein the retaining portion is defined by the first row of cells.

13. The expandable docking station frame according to claim 1, wherein the retaining portion is located on the first side of the waist, and the sealing portion is located on the first side of the waist between the waist and the retaining portion.

14. The extended docking station frame according to claim 13, wherein the retaining portion is a first retaining portion, and the extended docking station frame further comprises a second retaining portion located on the second side opposite to the first side of the waist.

15. The expandable docking station frame according to claim 14, wherein the sealing portion is a first sealing portion, and the expandable docking station frame further comprises a second sealing portion located on the second side of the waist portion between the waist portion and the second restraining portion.

16. Lumbar region and, A sealing portion connected to the waist, which is expandable radially outward from the waist, and which, in the deployed position, provides a seal to the inner surface of the circulating system over the range of its expanded size, A retaining portion connected to the sealing portion, which is extendable radially outward to engage with the inner surface of the circulating system at the deployment position in order to hold the docking station in the deployment position within the circulating system, A catheter including a sleeve configured to secure an expandable docking station before deployment to the circulatory system, In a system comprising an expandable docking station frame including, When the expandable docking station frame is expanded and in an unrestrained state, the sealing portion and the retaining portion are joined by concave contours radially inward of the first outermost diameter of the sealing portion and the second outermost diameter of the retaining portion, The second outermost diameter of the retaining portion is defined by the flared axial end of the expandable docking station frame, The sealing portion defines a convex contour, and at the deployment position, the convex contour extends radially outward to contact the inner surface of the circulating system.

17. The system according to claim 16, further comprising an expandable valve including an expandable frame that is expandable to engage with the waist portion of the docking station, and a valve element connected to the expandable frame.

Images