HK40055728A

HK40055728A - Devices and systems for docking a heart valve

Info

Publication number: HK40055728A
Application number: HK42021043982.4A
Authority: HK
Inventors: D·P·阿莫尔; M·D·富兰克林; S·德尔加多; E·M·艾伯特; A·乔什; D·L·斯瑞曼; R·T·约瑟夫; T·N·阮; S·V·阮; H·T·恩戈; V·特兰; C·L·鲍曼; S·J·罗
Original assignee: 爱德华兹生命科学公司
Priority date: 2016-02-05
Filing date: 2021-12-08
Publication date: 2022-03-18

Description

Device and system for docking a heart valve

The application is a divisional application, the application date of the original application is 2017, 2 and 3, the application number is 201780009758.3, and the name of the invention is 'device and system for docking heart valves'.

Technical Field

The present invention relates to heart valves, and in particular to docking stations/stents, delivery systems, and methods for implanting heart valves, such as transcatheter heart valves ("THVs").

Background

Prosthetic heart valves can be used to treat heart valve disease. The native heart valves (aortic, pulmonary, tricuspid and mitral) play a critical role in ensuring an adequate blood supply flows forward through the cardiovascular system. Congenital, inflammatory, or infectious diseases may render these heart valves less effective. This disease can ultimately lead to serious cardiovascular risk or death. The decisive treatment for this disease for many years has been surgical repair or valve replacement during open heart surgery.

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

Transcatheter Heart Valves (THVs) may be appropriately sized to be placed within most native aortic valves. However, for larger native valves, vessels, and grafts, the aortic transcatheter valve may be too small to be secured into a larger implantation or deployment site. In such cases, the transcatheter valve may not be large enough to expand sufficiently within the native valve or other implantation site or deployment site to be secured in place.

Replacing the pulmonary valve, which is sometimes referred to as a pulmonary valve, presents significant challenges. The geometry of the pulmonary artery can vary greatly from patient to patient. In general, the pulmonary artery outflow tract after corrective surgery is too wide for effective placement of a prosthetic heart valve.

Disclosure of Invention

This summary is intended to provide an example and is not intended to limit the scope of the present invention in any way. For example, the claims do not require any feature included in the examples of this summary unless the claims expressly define such feature. The description 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 may be constructed in various ways.

In one embodiment, for example, the docking station may include a valve seat (valve seat), one or more sealing portions, and one or more retaining portions. In one embodiment, the valve seat can be substantially non-expandable beyond the deployed dimension, i.e., the diameter of the valve seat can only be increased by 0-4 mm, at a maximum. One or more sealing portions may be connected to and extend radially outward of the valve seat. One or more sealing portions can be configured to expand and extend beyond the valve seat and provide a seal over a range of sizes (e.g., over a range of expanded sizes and/or over a range of sizes within the circulatory or vasculature, e.g., that can provide a seal when expanded in different vessels or locations of various shapes and sizes). The one or more retaining portions may be connected to the one or more sealing portions. The one or more retaining portions may be configured to retain the docking station in the deployed position. The expandable docking station is capable of expanding and providing a seal in the range of 27mm to 38 mm. The expandable docking station may expand radially outward to varying degrees along its length L. The valve seat and the one or more sealing portions may act as spacers, reducing or preventing the transfer of radially outward forces of the expandable valve in the valve seat to the one or more sealing portions or the one or more retaining portions. The docking station may be configured such that blood pressure is enhanced by the retention portion. The one or more retaining portions may be configured such that a force exerted by at least one of the one or more retaining portions at the deployed position is proportional to a blood pressure acting on the docking station. The one or more retaining portions may be configured such that a force exerted 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 of sutures, loops, straps (bands), structural arrangements, materials, foams, and in other ways. The sealing portion may include a portion of the metal frame covered with fabric, polymer, and/or other material. The sealing portion may comprise an open cell foam. Portions of the docking station may be permeable to blood and portions of the docking station may be impermeable to blood. The blood impermeable portion of the docking station may extend from at least the valve seat to at least the sealing portion. The length of the docking station may be adjustable. The docking station may include a first half into which a second half of the docking station is adjustably extendable to adjust the length. The one or more retaining portions may extend radially outward of the one or more sealing portions when the docking station is in the unconstrained state. Other features described elsewhere in this disclosure may also be included.

In one exemplary embodiment, a 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 is expandable to a deployed size. One or more sealing portions can be coupled to the valve seat and can be configured to expand and extend radially outward of the valve seat and provide a seal over a range of expanded sizes. The one or more retaining portions may be connected to the one or more sealing portions. The one or more retaining portions may be configured to retain the docking station in the deployed position. The expandable valve may include an expandable frame and a valve element. The expandable frame may be expanded to engage the valve seat of the docking station. The valve element may be connected to the expandable frame. The expandable docking station and expandable valve may be configured such that when implanted in a portion of the circulatory system, a radially outward force applied by the sealing portion to the portion of the circulatory system is less than 1/2 (and may be less than 1/3, less than 1/4, less than 1/8, or less than 1/10) of a radially outward force applied by the expandable frame to the valve seat when the sealing portion is within the size range. The expandable docking station may be configured such that, when implanted in a portion of the circulatory system, the diameter of the valve seat is increased by no more than 3mm (or no more than 1mm, 2mm, or 4mm) by a radially outward force applied by the expandable frame to the valve seat. The sealing portion may range in size from 27mm to 38 mm. The expandable docking station may be configured to expand radially outward to varying degrees along its length L when implanted in a portion of the circulatory system.

The expandable docking station may be configured such that blood pressure on the expandable docking station is enhanced retained by the retaining portion when implanted in a portion of the circulatory system. The expandable docking station may be configured such that a force exerted by the retaining portion when implanted in a portion of the circulatory system is proportional to blood pressure acting on the assembly. The expandable docking station may be configured such that a force exerted by the retaining portion when implanted in a portion of the circulatory system is greater when the heart is in diastole than when the heart is in systole. The valve seat can be formed from sutures, loops, straps, structural arrangements, materials, foams, and in other ways. The sealing portion may comprise a portion of the metal frame covered with fabric. The sealing portion may comprise an open cell foam. Portions of the docking station may be permeable to blood and portions of the docking station may be impermeable to blood. The blood impermeable portion of the docking station can extend from at least the valve seat to at least the sealing portion. The docking station may have an adjustable overall length. The docking station may include a first half (i.e., portion) into which a second half (i.e., portion) of the docking station is adjustably extendable to adjust the overall length. In other words, the length of the docking station may be adjusted by moving the second half/portion relative to the first half/portion, and the first half/portion may be moved independently of the second half/portion (e.g., one half/portion may remain in place while the other half/portion moves). If one of the first or second halves/portions extends within the other and overlaps to adjust the length, the first half/portion and the second half/portion may be adjusted to vary the amount/length of overlap between the two. The one or more retaining portions may extend radially outward of the one or more sealing portions when the docking station is in the unconstrained state. Other features described elsewhere in this disclosure may also be included.

In one exemplary embodiment, a method may include expanding a docking station and expanding a valve in the docking station. The docking station may be expanded such that the valve seat of the docking station is expanded to a valve seat deployment size and the sealing portion is expanded to a sealing size within a range of sealing sizes. The frame of the expandable valve may be expanded to engage the valve seat of the docking station. The radially outward force applied by the sealing portion within the sealing dimension range may be less than 1/2 (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 by the expandable frame to the valve seat upon expanding the frame. The valve seat of the docking station may be configured such that the diameter of the valve seat is increased by no more than 2mm (or no more than 1mm, 3mm, or 4mm) by a radially outward force applied by the expandable frame to the valve seat. The seal size of the docking station may range from 27mm to 38 mm. The valve seat can be formed from sutures, loops, straps, structural arrangements, materials, foams, and in other ways. Other features/steps described elsewhere in this disclosure may also be included.

In one exemplary embodiment, a 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 is expandable to a deployed size. One or more sealing portions may be connected to the valve seat and may extend radially outward of the valve seat. The one or more sealing portions may be configured to expand outward of the valve seat and provide a seal over a range of sizes. The one or more retaining portions may be connected to the one or more sealing portions. The one or more retaining portions may be configured to retain the docking station in the deployed position. The expandable valve may include an expandable frame and a valve element. The expandable frame is expandable to engage the valve seat of the docking station. The valve element may be connected to the expandable frame. Blood pressure acting on the valve and docking station may be enhanced at the deployed position by the retention portion.

The valve seat can be configured such that a radially outward force of the expandable valve does not substantially expand the valve seat radially outward. The sealing portion may range in size from 27mm to 38 mm. The docking station may be configured to expand radially outward to varying degrees along its length L. The force exerted by the retaining portion may be proportional to the blood pressure acting on the assembly. The force exerted 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 from sutures, loops, straps, structural arrangements, materials, foams, and in other ways. The sealing portion may comprise a portion of the metal frame covered with fabric. The sealing portion may comprise an open cell foam or other material. Portions of the docking station may be permeable to blood and portions of the docking station may be impermeable to blood. The blood impermeable portion of the docking station may extend from at least the valve seat to at least the sealing portion. The length of the docking station is adjustable. The docking station may include a first half (i.e., portion) into which a second half (i.e., portion) of the docking station is adjustably extendable to adjust the overall length. In other words, the length of the docking station may be adjusted by moving the second half/portion relative to the first half/portion, and the first half/portion and the second half/portion may be moved independently (e.g., one half/portion may remain in place while the other half/portion moves). If one of the first or second halves/portions extends within the other and overlaps to adjust the length, the first half/portion and the second half/portion may be adjusted to vary the amount/length of overlap between the two. The one or more retaining portions may extend radially outward of the one or more sealing portions when the docking station is in the unconstrained state. Other features described elsewhere in this disclosure may also be included.

In one exemplary embodiment, a method may include expanding a docking station and expanding a valve in the docking station. The docking station may be expanded such that the valve seat of the docking station is expanded to a valve seat deployment size and the sealing portion is expanded to a sealing size within a range of sealing sizes. The frame of the expandable valve may be expanded to engage the valve seat of the docking station. Blood pressure acting on the valve and docking station may be enhanced at the deployed position by the retention portion. The valve seat of the docking station may be configured such that the diameter of the valve seat is increased by no more than 2mm (or no more than 1mm, 3mm, or 4mm) by a radially outward force applied by the expandable frame to the valve seat. The seal size of the docking station may range from 27mm to 38 mm. The valve seat can be formed from sutures, loops, straps, structural arrangements, materials, foams, and in other ways. Other features/steps described elsewhere in this disclosure may also be included.

In one embodiment, for example, the docking station may include a valve seat, and one or more sealing portions. The valve seat can be expanded to a deployed size. One or more sealing portions may be connected to and extend radially outward of the valve seat. The one or more sealing portions may be configured to expand outward of the valve seat and provide a seal over a range of sizes. 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 is adjustably extendable to adjust the overall length. In other words, the length of the docking station may be adjusted by moving the second half/portion relative to the first half/portion, and the first half/portion may be moved independently of the second half/portion (e.g., one half/portion may remain in place while the other half/portion moves). If one of the first or second halves/portions extends within the other and overlaps to adjust the length, the first half/portion and the second half/portion may be adjusted to vary the amount/length of overlap between the two.

The valve seat can be constructed such that a radially outward force of the expandable valve is substantially unable to expand the valve seat radially outward. The sealing portion may range in size from 27mm to 38 mm. The docking station may be configured to expand radially outward to varying degrees along its length L. The valve seat and the one or more sealing portions may act as an isolator, substantially preventing radially outward forces of the expandable valve from being transferred to the one or more sealing portions. The valve seat can be formed from sutures, loops, straps, structural arrangements, materials, foams, and in other ways. The sealing portion may comprise a portion of the metal frame covered with fabric. The sealing portion may comprise an open cell foam. Portions of the docking station may be permeable to blood and portions of the docking station may be impermeable to blood. Other features described elsewhere in this disclosure may also be included.

In one exemplary embodiment, a 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 is expandable to a deployed size. One or more sealing portions may be connected to the valve seat and may extend radially outward of the valve seat. The one or more sealing portions may be configured to expand outward of the valve seat and provide a seal over a range of sizes. The length of the docking station may be adjustable, for example, in the same or similar manner as discussed elsewhere herein. The expandable valve may include an expandable frame and a valve element. The expandable frame is expandable to engage the valve seat of the docking station. The valve element may be connected to the expandable frame. The second half of the docking station may extend into the first half of the docking station such that the length of the docking station is adjustable. The valve seat can be configured such that a radially outward force of the expandable valve does not substantially expand the valve seat radially outward. The docking station may be configured to expand radially outward to varying degrees along its length L. The valve seat can be formed from sutures, loops, straps, structural arrangements, materials, foams, and in other ways. The sealing portion may comprise a portion of the metal frame covered with fabric. The sealing portion may comprise an open cell foam. Portions of the docking station may be permeable to blood and portions of the docking station may be impermeable to blood. Other features described elsewhere in this disclosure may also be included.

In one exemplary embodiment, a method may include expanding a multi-piece (multiple piece) docking station and expanding a valve in the docking station. The first docking station half or section may be expanded. The second docking station half or a portion/section of the portion may be positioned in the first docking station half, for example, such that the desired lengths overlap. The second docking station half may be expanded in the first docking station half to set the length of the docking station. The docking station may have a valve seat and a sealing portion. The frame of the expandable valve may be expanded to engage the valve seat of the docking station. The valve seat can be configured such that a radially outward force of the expandable valve does not substantially expand the valve seat radially outward. The predetermined size of the sealing portion of the docking station may be 27mm to 38 mm. The valve seat can be formed from sutures, loops, straps, structural arrangements, materials, foams, and in other ways. Other features/steps described elsewhere in this disclosure may also be included.

In one exemplary embodiment, a 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 the proximal end and may have one or more side openings. The delivery catheter may be configured such that injecting the irrigating fluid into the proximal end of the inner tube flushes the irrigating fluid through the inner tube, wherein at least some of the irrigating fluid exits the inner tube through the one or more side openings to fill the gap and flush air out of the distal opening of the outer tube. The inner tube may have a distal opening and the delivery catheter may be configured such that filling the inner tube with an irrigation fluid at the proximal end flushes air out of the distal opening of the inner tube. The inner tube may be filled with an irrigation fluid at an opening for a guidewire at a proximal end of the inner tube. The delivery catheter may be configured such that air in the inner tube may be flushed out through the distal opening of the inner tube and through an opening in a nose cone (nonsecone) that may be connected to the inner tube. Other features described elsewhere in this disclosure may also be included.

In one exemplary embodiment, the method may flush air out of the delivery catheter. The delivery catheter may include an outer tube having a distal opening, an inner tube having a proximal opening at a proximal end of the inner tube and one or more side openings, and a gap formed between the inner and outer tubes. An irrigation fluid may be injected into the proximal end of the inner tube such that the irrigation fluid flows through the inner tube and at least some of the irrigation fluid exits the inner tube through the one or more side openings to fill the gap and flush air out of the distal opening of the outer tube. The inner tube may be filled with an irrigation fluid through the proximal opening, and the proximal opening may also be used to pass a guidewire through the delivery catheter. The delivery catheter may also be inserted into the blood vessel after the air has been flushed out. Other features/steps described elsewhere in this disclosure may also be included.

In one exemplary embodiment, a catheter and docking station system includes a sleeve, a docking station holder, and a docking station. The docking station holder may be disposed in the sleeve. The docking station holder may include one or more holder recesses. The docking station may be disposed in the sleeve. The docking station may include one or more extensions releasably attached to the docking station holder. Each of the one or more extensions may include a head disposed in at least one of the one or more retainer grooves. Each of the one or more docking extensions may be configured to contact the docking station holder at only two points. The head may be triangular and may comprise two heads. One or more of the holder recesses in the docking station holder may be a rectangular recess. The sides of the head may extend away from each other at an angle between 60 degrees and 120 degrees. The sleeve may engage the one or more extensions to retain the one or more heads in the retainer groove when the sleeve is positioned over the one or more extensions. The one or more extensions may spring radially outward (spring) relative to the docking station holder when unconstrained by the sleeve to release the one or more extensions from the docking station holder. One or more extensions may be angled in one or more grooves. Other features described elsewhere in this disclosure may also be included.

In one exemplary embodiment, a method of using a docking station may include placing a head of a docking station extension into a recess of a docking station holder such that the docking station extension contacts the docking station holder with only two points. The docking station and docking station holder may be placed in the sleeve. The sleeve may engage the docking station extension to retain the head of the docking station extension in the recess. The head may be triangular. The recess in the docking station holder may be a rectangular recess. The sides of the head may extend away from each other at an angle between 60 degrees and 120 degrees. The holder 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 holder to release the docking station extension from the docking station holder. The extension may be inclined in the groove. Other features/steps described elsewhere in this disclosure may also be included.

In one exemplary embodiment, an assembly for deploying a docking station includes a handle and a catheter. The handle may include a housing, a driving member, and a driven member. The drive member may be rotatably coupled to the housing. The driven member may be coupled to the drive member and the housing such that rotation of the drive member linearly moves the driven member in the housing. The catheter may include an outer sleeve and an inner sleeve. The outer sleeve may be fixedly connected to the driven member. The inner sleeve may be disposed within the outer sleeve and may be fixedly connected to the housing. Rotation of the drive member may move the outer sleeve relative to the inner sleeve. The drive member may comprise a wheel having a geared portion. The drive member may comprise an internally threaded member. The driven member may comprise a rack. The driven member may comprise an externally threaded member. The ratchet mechanism is movable from an engaged position to a disengaged position such that the drive member can only rotate in one direction when the ratchet is in the engaged position. A luer port may be secured to the inner sleeve. The luer and the inner sleeve may be configured to receive a guidewire extending through the inner shaft. Other features described elsewhere in this disclosure may also be included.

In one exemplary embodiment, a method of deploying a docking station may include rotating a driving member relative to a housing to linearly move a driven member in the housing. The inner sleeve may be fixed to the housing and the outer sleeve may be fixed to the driven member. Rotation of the drive member moves the outer sleeve relative to the inner sleeve. The driving member may move the driven member linearly by engagement of the gear teeth. The drive member may move the driven member linearly by engagement of the threads. The drive member may be configured to rotate in only one direction. The first and second sleeves may be moved over the guidewire.

Various features described elsewhere in this disclosure may be included in the examples summarized herein, and various methods and steps using the examples and features, including those described elsewhere herein, may be utilized.

A further understanding of the nature and advantages of the disclosed invention may be realized by the following description and claims, particularly when considered in conjunction with the accompanying drawings in which like parts bear the same reference numerals.

Drawings

To further clarify various aspects of embodiments of the present disclosure, a more particular description of certain embodiments will be rendered by reference to various aspects of the appended drawings. It is appreciated that these drawings depict only typical embodiments of the disclosure and are therefore not to be considered limiting of its scope. Moreover, while the figures are drawn to scale for some embodiments, the figures are not necessarily drawn to scale for all embodiments. Embodiments of the present disclosure will be described and illustrated with additional specificity and detail through the use of the accompanying drawings.

FIG. 1A is a cross-sectional view of a human heart in diastole;

FIG. 1B is a cross-sectional view of a human heart in systole;

FIGS. 2A-2E are cross-sectional views of pulmonary arteries illustrating that the pulmonary arteries can have a variety of different shapes and sizes;

3A-3D are perspective views of pulmonary arteries illustrating that the pulmonary arteries can have a variety of different shapes and sizes;

FIG. 4A is a schematic view of a compressed docking station positioned in the circulatory system;

FIG. 4B is a schematic view of the docking station of FIG. 4A expanded to set the position of the docking station in the circulatory system;

fig. 4C is a schematic view of an expandable transcatheter heart valve positioned in the docking station illustrated in fig. 4B;

FIG. 4D is a schematic view of the transcatheter heart valve of FIG. 4C expanded to set the position of the heart valve in a docking station;

fig. 4E illustrates the docking station and transcatheter heart valve deployed in an irregularly shaped portion of the circulatory system;

fig. 4F illustrates the docking station and transcatheter heart valve deployed in a pulmonary artery;

FIG. 5A is a schematic view of a compressed docking station positioned in the circulatory system;

FIG. 5B is a schematic view of the docking station of FIG. 5A expanded to set the position of the docking station in the circulatory system;

FIG. 5C is a schematic view of an expandable transcatheter heart valve positioned in the docking station illustrated in FIG. 5B;

FIG. 5D is a schematic view of the transcatheter heart valve of FIG. 5C expanded to set the position of the heart valve in a docking station;

fig. 5E illustrates the docking station and transcatheter heart valve deployed in an irregularly shaped portion of the circulatory system;

fig. 5F illustrates the docking station and transcatheter heart valve deployed in a pulmonary artery;

FIG. 6A is a cross-sectional view of a human heart in systole with a docking station and deployed in a pulmonary artery;

FIG. 6B is a cross-sectional view of a human heart in systole with a docking station and transcatheter heart valve deployed in a pulmonary artery;

FIG. 7A is an enlarged schematic view of the docking station and transcatheter heart valve of FIG. 6B with the heart in systole;

FIG. 7B is a view taken in the direction indicated by line 7B-7B in FIG. 7A;

FIG. 7C is a graph showing the relationship between the docking station diameter and the radially outward force exerted by the docking station;

FIG. 8 is a cross-sectional view of a human heart in diastole with a docking station and transcatheter heart valve deployed in a pulmonary artery;

FIG. 9A is an enlarged schematic view of the docking station and transcatheter heart valve of FIG. 8 with the heart in diastole;

FIG. 9B is a view taken in the direction indicated by line 9B-9B in FIG. 9A;

FIG. 10A illustrates an exemplary embodiment of a docking station with a transcatheter heart valve disposed within the docking station;

FIG. 10B illustrates an exemplary embodiment of a docking station with a transcatheter heart valve disposed within the docking station;

FIG. 10C illustrates an exemplary embodiment of a docking station with a transcatheter heart valve disposed within the docking station;

FIG. 10D illustrates an exemplary embodiment of a docking station with a transcatheter heart valve disposed within the docking station;

FIG. 11A illustrates an exemplary embodiment of a telescoping docking station;

FIG. 11B illustrates an exemplary embodiment of a telescoping docking station;

FIG. 11C illustrates an exemplary embodiment of a telescoping docking station;

FIG. 11D illustrates an exemplary embodiment of a telescoping docking station;

FIG. 12A illustrates an exemplary embodiment of a docking station with a transcatheter heart valve disposed within the docking station;

FIG. 12B illustrates an exemplary embodiment of a docking station with a transcatheter heart valve disposed within the docking station;

fig. 12C illustrates an exemplary embodiment of a docking station with a transcatheter heart valve disposed within the docking station;

FIG. 12D illustrates an exemplary embodiment of a docking station with a transcatheter heart valve disposed within the docking station;

FIG. 13A illustrates an exemplary embodiment of a telescoping docking station;

FIG. 13B illustrates an exemplary embodiment of a telescoping docking station;

FIG. 13C illustrates an exemplary embodiment of a telescoping docking station;

FIG. 13D illustrates an exemplary embodiment of a telescoping docking station;

FIG. 14A illustrates an exemplary embodiment of a docking station with a transcatheter heart valve disposed within the docking station;

FIG. 14B illustrates an exemplary embodiment of a docking station with a transcatheter heart valve disposed within the docking station;

fig. 14C illustrates an exemplary embodiment of a docking station with a transcatheter heart valve disposed within the docking station;

FIG. 14D illustrates an exemplary embodiment of a docking station with a transcatheter heart valve disposed within the docking station;

FIG. 14E illustrates an exemplary embodiment of a docking station with a transcatheter heart valve disposed within the docking station;

fig. 14F illustrates an exemplary embodiment of a docking station with a transcatheter heart valve disposed within the docking station;

fig. 14G illustrates an exemplary embodiment of a docking station with a transcatheter heart valve disposed within the docking station;

FIG. 15A is a side view of an exemplary embodiment of a frame of a docking station;

FIG. 15B illustrates a side profile of the frame illustrated in FIG. 15A;

FIG. 16 illustrates the docking station frame of FIG. 15A in a compressed state;

FIG. 17A is a perspective view of the docking station frame of FIG. 15A;

FIG. 17B is a perspective view of the docking station frame of FIG. 15A;

FIG. 18 is a perspective view of an exemplary embodiment of a docking station having a plurality of covered chambers and a plurality of open chambers;

FIG. 19 is a perspective view of the exemplary docking station of FIG. 18 with portions cut away to illustrate the transcatheter heart valve expanded into position in the docking station;

fig. 20 illustrates a side profile of the docking station illustrated in fig. 18 when implanted in a blood vessel of the circulatory system;

FIG. 21 illustrates a perspective view of the docking station illustrated in FIG. 18 when implanted in a blood vessel of the circulatory system;

fig. 22 illustrates a perspective view of the docking station and valve illustrated in fig. 19 when implanted in a vessel of the circulatory system;

FIGS. 23A and 23B illustrate side profiles of the docking station illustrated in FIG. 18 when implanted in a different sized vessel of the circulatory system;

fig. 24 and 25 illustrate side profiles of the docking stations of the example of fig. 18 when implanted in different sized vessels of the circulatory system, with schematic example transcatheter heart valves of the same size mounted or deployed in each docking station;

FIG. 26A is a cross-sectional view illustrating a side profile of an exemplary embodiment of a docking station disposed in a pulmonary artery;

FIG. 26B is a cross-sectional view illustrating a side profile of an exemplary embodiment of a docking station placed in a pulmonary artery and an exemplary valve placed in the docking station;

FIG. 26C is a cross-sectional view illustrating an exemplary embodiment of a docking station placed in a pulmonary artery and a valve placed in the docking station;

FIG. 27 is a side view of an exemplary embodiment of a docking station;

FIG. 28 is a side view of an exemplary embodiment of a telescoping docking station;

FIG. 29 is a side view of the docking station of FIG. 28 with two portions of the docking station nested together;

FIG. 30 is a cross-sectional view illustrating the docking station disposed in a pulmonary artery;

FIG. 31A is a cross-sectional view illustrating a side profile of an exemplary embodiment of a docking station disposed in a pulmonary artery;

FIG. 31B is a cross-sectional view illustrating a side profile of an exemplary embodiment of a docking station placed in a pulmonary artery and a valve placed in the docking station;

FIG. 32A is a cross-sectional view of a human heart in systole with a docking station and deployed in a pulmonary artery;

FIG. 32B is a cross-sectional view of a human heart in systole with a docking station and transcatheter heart valve deployed in a pulmonary artery;

FIG. 33A is an enlarged schematic view of the docking station and transcatheter heart valve of FIG. 32B with the heart in systole;

FIG. 33B is a view taken in the direction indicated by line 33B-33B in FIG. 33A;

FIG. 34 is a cross-sectional view of the exemplary human heart, docking station deployed in a pulmonary artery, and transcatheter heart valve of FIG. 32B with the heart in diastole;

FIG. 35A is an enlarged schematic view of the docking station and transcatheter heart valve of FIG. 34 when the heart is in diastole;

FIG. 35B is a view taken in the direction indicated by line 35B-35B in FIG. 35A;

FIG. 36A is a cross-sectional view of a human heart in systole with a docking station being deployed in a pulmonary artery;

FIG. 36B is a cross-sectional view of a human heart in systole with a docking station deployed in a pulmonary artery;

FIG. 36C is a cross-sectional view of a human heart in systole with a docking station and transcatheter heart valve deployed in a pulmonary artery;

FIG. 37A is an enlarged schematic view of the docking station and transcatheter heart valve of FIG. 36C with the heart in systole;

FIG. 37B is a view taken in the direction indicated by line 37B-37B in FIG. 37A;

FIG. 38 is a cross-sectional view of the exemplary human heart, docking station deployed in a pulmonary artery, and transcatheter heart valve of FIG. 36C with the heart in diastole;

FIG. 39A is an enlarged schematic view of the docking station and transcatheter heart valve of FIG. 38 when the heart is in diastole;

FIG. 39B is a view taken in the direction indicated by line 39B-39B in FIG. 39A;

FIG. 40A is a cross-sectional view of a human heart in systole with a docking station being deployed in a pulmonary artery;

FIG. 40B is a cross-sectional view of a human heart in systole with a docking station deployed in a pulmonary artery;

FIG. 40C is a cross-sectional view of a human heart in systole with a docking station and transcatheter heart valve deployed in a pulmonary artery;

FIG. 41A is an enlarged schematic view of the docking station and transcatheter heart valve of FIG. 40C with the heart in systole;

FIG. 41B is a view taken in the direction indicated by line 41B-41B in FIG. 41A;

FIG. 42 is a cross-sectional view of the exemplary human heart of FIG. 40C, docking station deployed in a pulmonary artery, and transcatheter heart valve when the heart is in diastole;

FIG. 43A is an enlarged schematic view of the docking station and transcatheter heart valve of FIG. 42 when the heart is in diastole;

FIG. 43B is a view taken in the direction indicated by line 43B-43B in FIG. 43A;

44-47, and 48A-48C illustrate examples of valve types that may be deployed in a docking station (e.g., one of the docking stations described or depicted herein);

FIG. 49A is a cross-sectional view of an exemplary embodiment of a catheter;

FIG. 49B is a cross-sectional view of an exemplary embodiment of a catheter with the docking station crimped and loaded therein;

FIGS. 50A-50D illustrate deployment from a docking station of a catheter;

FIG. 51 is a side view of an exemplary embodiment of a nose cone of a catheter;

FIG. 52 is a view taken as indicated by line 52-52 in FIG. 51;

FIG. 53 is a cross-sectional view of an exemplary embodiment of a distal portion of a catheter;

FIG. 54 is a side view of an exemplary embodiment of a nose cone of a catheter;

FIG. 55 is a cross-sectional view of an exemplary embodiment of a distal portion of a catheter;

FIG. 56 is a perspective view of a holder for holding the docking station in the conduit;

FIG. 57 is a perspective view of a holder for holding the docking station in the conduit;

FIGS. 57A and 57B illustrate side views of an extension of a docking station disposed in a holder;

FIG. 58 is a cross-sectional view of an exemplary embodiment of a handle of a catheter of a docking station;

FIG. 59 is an exploded perspective view of a portion of the handle of FIG. 58;

FIG. 60 is an exploded cross-sectional view of a portion of the handle of FIG. 58;

FIG. 61 is an exploded perspective cross-sectional view of a portion of the handle of FIG. 58;

FIG. 62 is a view of an exemplary embodiment of a handle of a docking station catheter with the side cover removed;

FIG. 63 is an enlarged portion of FIG. 62 illustrating the catheter's irrigation system;

fig. 64A and 64B are views of the handle of the example of fig. 62 with the opposite side covers removed to illustrate extension and retraction of the outer sleeve of the docking station catheter;

FIG. 65 is an exploded view of the handle of FIG. 62;

FIG. 66 is a perspective view of the handle illustrated in FIG. 62 with the opposite side cover removed;

FIG. 67 is a side view of the handle illustrated in FIG. 62;

FIG. 68 is a side view of the indexing wheel (indexing wheel) of the handle of the example of FIG. 62 in a ratcheting state;

FIG. 69 is a perspective view of the index wheel of FIG. 68 in a ratcheting state;

FIG. 70 is an enlarged portion of FIG. 69;

FIG. 71 is a partial cross-sectional view of the indexing wheel of the example of FIG. 68 disposed in a handle housing;

FIG. 72 is a view similar to FIG. 71 in a separated state; and

FIG. 73 is a side view of the index wheel of the handle illustrated in FIG. 62 in a separated state.

Detailed Description

The following description refers to the accompanying drawings that illustrate specific embodiments of the present invention. Other embodiments having different structures and operations do not depart from the scope of the present invention. Exemplary embodiments of the present disclosure relate to devices and methods for providing a docking station or landing zone (landing zone) to a transcatheter heart valve ("THV"), e.g., THV 29. In some exemplary embodiments, a docking station for THV is exemplified for use within the pulmonary artery, although the docking station (e.g., docking station 10) may be used for anatomical structures, the heart, or other areas of the vasculature such as the superior vena cava or inferior vena cava. The docking stations described herein may be configured to compensate for deployed THVs that are smaller than such spaces (e.g., anatomy/vasculature/etc.): the THV will be placed in the space.

It should be noted that various embodiments of docking stations and systems for delivery and implantation are disclosed herein, and any combination of these options may be made, unless specifically 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 the specific combination is not explicitly described. Likewise, different configurations of docking stations and valves may be mixed and matched, such as by combining any of the docking station types/features, valve types/features, tissue coverage (cover), and the like, even if not explicitly disclosed. In short, the various components of the disclosed system may be combined unless mutually exclusive or otherwise physically impossible.

For purposes of consistency, docking stations are depicted in these figures and others of the present application such that the pulmonary bifurcation end (pulmonary bifurcation end) is superior and the ventricular end is inferior. These directions are also referred to as "distal" as a synonym for the end of an upper or pulmonary bifurcation and "proximal" as a synonym for the end of a lower or ventricular end, which is a term relative to the physician's perspective.

Fig. 1A and 1B are sectional views of a human heart H in diastole and systole, respectively. The right ventricle RV and the left ventricle LV pass through the tricuspid valve TV and the mitral valve MV, respectively; i.e. the atrioventricular valve is separated from the right atrium RA and the left atrium LA. In addition, the aortic valve AV separates the left ventricle LV from the ascending aorta (not indicated) and the pulmonary valve PV separates the right ventricle from the pulmonary artery PA. Each of these valves has flexible leaflets that extend inwardly across the respective orifice that come together or "close" in flow (flowstream) to form a unidirectional fluid-occluding plane. The docking station and valve of the present application are described primarily with respect to a pulmonary valve. Thus, the anatomy of the right atrium RA and right ventricle RV will be explained in more detail. It should be understood that the devices described herein may also be used in other areas, for example, in the inferior and/or superior vena cava for treating regurgitation or otherwise defective tricuspid valves, in the aorta (e.g., enlarged aorta) for treating defective aortic valves, in other areas of the heart or vasculature, in grafts, and the like.

The right atrium RA receives deoxygenated blood from the venous system via the superior vena cava SVC and the inferior vena cava IVC, the former entering the right atrium from above and the latter entering the right atrium from below. The coronary sinus CS is an aggregation of veins that merge together to form a large vessel that aggregates deoxygenated blood from the heart muscle (myocardium) and delivers it to the right atrium RA. During diastole or diastole, seen in fig. 1A, venous blood collecting in the right atrium RA enters the tricuspid valve TV by expansion of the right ventricle RV. During systole or systole, seen in fig. 1B, the right ventricle RV contracts to force venous blood through the pulmonary valve PV and pulmonary artery into the lungs. In one exemplary embodiment, the device described by the present application is used to replace or supplement the function of a defective pulmonary valve. During systole, the leaflets of the tricuspid valve TV close to prevent venous blood backflow into the right atrium RA.

Referring to fig. 2A-2E and 3A-3D, non-exhaustive examples are shown that the pulmonary artery can have a wide variety of different shapes and sizes. For example, as shown in the cross-sectional views of fig. 2A-2E and the perspective views of fig. 3A-3D, the length L, diameter D, and curvature or contour (contour) may vary greatly between pulmonary arteries of different patients. In addition, the diameter D may vary significantly along the length L of the pulmonary artery of an individual. These differences can be even more pronounced in pulmonary arteries that suffer from certain diseases and/or have been damaged by previous surgery. For example, treatment of faruette-Tetrad (TOF) or aortic malposition (TGA) often results in larger and more irregularly shaped pulmonary arteries.

Faruetetrad (TOF) is a cardiac abnormality that refers to a combination of four related cardiac defects that commonly occur together. Four defects are Ventricular Septal Defect (VSD), aortic straddling (aortic valve is enlarged and appears to rise from both the left and right ventricles rather than from the left ventricle as in a normal heart), pulmonary valve stenosis (narrowing of the pulmonary valve and outflow tract or the sub-valvular area that creates an obstruction to blood flow from the right ventricle to the pulmonary artery), and right ventricular hypertrophy (thickening of the muscular wall of the right ventricle, which occurs because the right ventricle pumps at high pressure).

Aortic malposition (TGA) refers to an abnormality in which the aorta and pulmonary arteries are "transposed" (transposed) from their normal positions such that the aorta rises from the right ventricle and the pulmonary arteries rise from the left ventricle.

Surgical treatment of some diseases involves longitudinal incisions along one of the pulmonary arteries, up to and along the pulmonary artery branches (pulmony branches). The incision may eliminate or significantly impair the function of the pulmonary valve. Trans-annular patches are used to cover the incision after surgery. The transannular patch reduces stenosis or constrained disease of the pulmonary artery PA associated with other procedures. However, injury or removal of the pulmonary valve PV can produce significant regurgitation, and prior to the present invention, post open heart surgery is often required to replace the pulmonary valve. Trans-annular patch techniques can result in a wide degree of size and shape variation of the pulmonary artery (see FIGS. 3A-3D)

Referring to fig. 4A-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 one or more sealing portions 410 provide a seal between the docking station 10 and the inner surface 416 of the circulatory system. The valve seat 18 provides a support surface for implanting or deploying the valve 29 in the docking station 10 after the docking station 10 is implanted in the circulatory system. The retaining portion 414 assists in retaining the docking station 10 and valve 29 in an implanted position or deployment site in the circulatory system. The expandable docking station 10 and valve 29 described in the various embodiments herein also represent various docking stations and/or valves that may be known or that may be developed, for example, various different types of valves may be substituted and/or used as the valve 29 in the various docking stations.

Fig. 4A-4D schematically illustrate an exemplary deployment of the docking station 10 and valve 29 in the circulatory system. Referring to fig. 4A, the docking station 10 is in a compressed form/configuration and is introduced to a deployment site in the circulatory system. For example, the docking station 10 may be positioned at a deployment site in a pulmonary artery by a catheter (e.g., catheter 3600 shown in fig. 50A-50D). Referring to fig. 4B, the docking station 10 is expanded in the circulatory system such that the one or more sealing portions 410 and retaining portions 414 engage an inner surface 416 of a portion of the circulatory system. Referring to fig. 4C, after deployment of the docking station 10, the valve 29 is in a compressed form and introduced into the valve seat 18 of the docking station 10. Referring to fig. 4D, the valve 29 is expanded in the docking station so that the valve 29 engages the valve seat 18. In the example 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 the valve 29 or shorter than the valve 29. Similarly, the length of the valve seat 18 may be longer, shorter, or the same as the length of the valve 29.

Referring to fig. 4D, the valve 29 has been expanded so that the seat 18 of the docking station supports the valve. The valve 29 need only expand against the stenotic seat 18 and not against the wider space within the portion of the circulatory system occupied by the docking station 10. The docking station 10 allows the valve 29 to operate within the expanded diameter range for which it is designed.

Fig. 4E illustrates that the inner surface 416 of the circulatory system, such as the inner surface of the anatomy of a blood vessel or heart, may vary in cross-sectional size and/or shape along its length. In an exemplary embodiment, the docking station 10 is configured to expand radially outward along its length L to varying degrees to conform to the shape of the inner surface 416. In an exemplary embodiment, the docking station 10 is configured such that the one or more sealing portions 410 and/or the one or more retaining portions engage the inner surface 416, although the shape of the anatomy of the vessel or heart varies significantly along the length L of the docking station. The docking station may be made of a very elastic or compliant material to accommodate large changes in the anatomy. For example, the docking station may be made of a highly flexible metal, metal alloy, polymer, or open cell foam. Examples of metals and metal alloys that may be used include, but are not limited to, nitinol, elgiloy (elgiloy), and stainless steel, although other metals and highly elastic or compliant non-metallic materials may be used. For example, the docking station 10 may have a frame or portions of a frame (e.g., a self-expanding frame, one or more retaining portions, one or more sealing portions, a valve seat, etc.) made of these materials, e.g., 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 will self-expand back to its pre-compressed diameter.

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

Fig. 4F illustrates the docking station 10 and valve 29 implanted in the pulmonary artery PA. As mentioned in relation to fig. 2A-2E and 3A-3D, the shape of the pulmonary artery may vary significantly along its length. In one exemplary embodiment, the docking station 10 is configured to conform to the changing shape of the pulmonary artery PA in the same manner as described in relation to fig. 4E.

Referring to fig. 5A-5F, in one exemplary embodiment, the expandable docking station 10 is made of an expandable foam material, such as open cell biocompatible foam. The outer surface 510 of the foam material may act as the sealing portion 410. In this example, the valve seat 18 may be provided on the inner surface 512 of the foam material as illustrated, or the inner surface 512 may act as a valve seat. In the example illustrated in fig. 5A-5F, the retaining portion 414 is omitted, although a retaining portion may be used. In one embodiment, the foam material may be used with an expandable frame (e.g., of metal, shape memory material, etc.). The foam material may cover or extend the entire length of the frame or only a portion of the length of the frame.

Fig. 5A-5D schematically illustrate deployment of the foam docking station 10 and valve 29 in the circulatory system. Referring to fig. 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 at a deployment site in a pulmonary artery by a catheter (e.g., catheter 3600 shown in fig. 50A-50D). Referring to fig. 5B, the docking station 10 is expanded in the circulatory system such that the sealing portion 410 engages the inner surface 416 of the circulatory system. Referring to fig. 5C, after deployment of the docking station 10, the valve 29 is in a compressed form and introduced into the valve seat 18 or the inner surface 512 of the docking station 10. Referring to fig. 5D, the valve 29 is expanded in the docking station such that the valve 29 engages the valve seat 18 or the inner surface 512 (e.g., where the inner surface 512 acts as a valve seat).

Fig. 5E illustrates that the inner surface 416 of the circulatory system, such as the inner surface of the anatomy of a blood vessel or heart, may vary in cross-section along its length. In an exemplary embodiment, the foam docking station 10 is configured to expand radially outward along its length L to varying degrees to conform to the shape of the inner surface 416.

Fig. 5F illustrates the foam docking station 10 and valve 29 implanted in the pulmonary artery PA. As mentioned in relation to fig. 2A-2E and 3A-3D, the shape of the pulmonary artery may vary significantly along its length. In an exemplary embodiment, the docking station 10 is configured to conform to the changing shape of the pulmonary artery PA in the same or similar manner as described in relation to fig. 4E.

Referring to fig. 6A, a docking station, such as that described with respect to fig. 4A-4D, is deployed in the pulmonary artery PA of the heart H. Fig. 6B illustrates the valve 29 deployed in the docking station 10 illustrated in fig. 6A. In fig. 6A and 6B, the heart is in systole. Fig. 7A is an enlarged representation of docking station 10 and valve 29 in pulmonary artery 29 of fig. 6B. The valve 29 is open when the heart is in systole. Blood flows from the right ventricle RV and through the pulmonary artery PA, docking station 10, and valve 29 as indicated by arrow 602. Fig. 7B illustrates space 608, which shows valve 29 open when the heart is in systole. Fig. 7B does not show the interface between the docking station 10 and the pulmonary artery to simplify the drawing. The cross-hatching in fig. 7B illustrates blood flow through an open valve. In an exemplary embodiment, the one or more sealing portions 410 prevent blood from flowing between the pulmonary artery PA and the docking station 10, and the seating (sealing) of the valve 29 in the seat 18 of the docking station 10 prevents blood from flowing between the docking station 10 and the valve 29. In this example, blood flows substantially only or only through the valve 29 when the heart is in systole.

Fig. 8 illustrates the valve 29, docking station 10, and heart H of the example of fig. 6B when the heart is in diastole. Referring to fig. 9A and 9B, the valve 29 is closed when the heart is in diastole. Fig. 9A is an enlarged representation of docking station 10 and valve 29 in pulmonary artery 29 of fig. 8. Blood flow in the pulmonary artery PA above the valve 29 (i.e., in the pulmonary artery branch 760) is blocked by the valve 29 being in a position to close and block blood flow as indicated by arrow 900. The solid area (solid area)912 in fig. 9B indicates that the valve 29 is closed when the heart is in diastole.

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

When the docking station is not in use, the THV holder and frame are held in place in the circulatory system by a relatively high radially outward force 710 of the THV holder or frame 712 acting directly on the circulatory system inner surface 416. If a docking station is used, as in the example illustrated in fig. 7A, the holder or frame 712 of the valve 29 is expanded or is expanded radially outward to impart a high force 710 on the valve seat 18 of the docking station 10. This high radially outward force 710 secures the valve 29 to the valve seat 18 of the docking station 10. However, because the valve seat 18 is not expanded by the force 710 or is not substantially expanded by the force 710, the force 710 is isolated from the circulatory system and is not used to secure the docking station in the circulatory system.

In an exemplary embodiment, the radially outward force 722 of the sealing portion 410 against the inner surface 416 is substantially less than the radially outward force 710 applied by the valve 29 against the valve seat 18. For example, the radially outward sealing force 722 may be less than 1/2 of the radially outward force 710 exerted by the valve, less than 1/3 of the radially outward force 710 exerted by the valve, less than 1/4 of the radially outward force 710 exerted by the valve, less than 1/8 of the radially outward force 710 exerted by the valve, or even less than 1/10 of the radially outward force 710 exerted by the valve. In an exemplary embodiment, the radially outward force 722 of the sealing portion 410 is selected to provide a seal between the inner surface 416 and the sealing portion 410, but is insufficient to maintain the position of the valve 29 and docking station 10 in the circulatory system by itself.

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

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

Referring to fig. 9A, when the heart is in diastole, the valve 29 is closed and blood flow is blocked as indicated by arrow 900. Since the valve 29 is closed and the valve 29 and docking station 10 block blood flow, the pressure P exerted by the blood on the docking station 10 and valve 29 is high as indicated by the large arrow P in fig. 9A. This large pressure P forces the lower retaining portion 414 against the surface 416 generally in the direction indicated by the large arrow F. This blood flow assisted force F applied by the retaining portion F to the surface 416 prevents the docking station 10 and valve 29 from moving in the direction indicated by arrow 900.

Since the force applied by the upper and lower retaining portions 414 depends on the amount of pressure applied by the blood to the valve 29 and docking station 10, the force applied to the surface 416 is automatically proportional. That is, the force with which the upper retaining portion presses against surface 416 when the heart is in systole is less than the force with which the lower retaining portion presses against surface 416 when the heart is in diastole. This is because the pressure against the open valve 29 and docking station 10 in systole is less than the pressure against the closed valve and docking station in diastole.

The valve seat 18 and the sealing portion 410 can take a wide variety of different forms. For example, the valve seat 18 may be any structure that is not or is not substantially expanded radially outward by the radially outward force of the THV (i.e., the valve seat in the deployed position/configuration may not or may be expanded less than 4mm in diameter, e.g., the diameter may only be expanded 1-4 mm large when the valve is deployed in the valve seat). For example, the valve seat 18 may include sutures or a metal ring that resists or limits expansion. However, in one embodiment, the valve seat 18 (or any of the valve seats described herein) may expand over a greater range, for example, the diameter may be between 5mm and 30mm large when the valve is deployed in the valve seat. In one embodiment, the diameter may expand from a diameter of 5mm or 6mm to a diameter of 20 mm-29 mm, 24mm, 26mm, 29mm, etc., or from and to different diameters within this range. Even though more expandable, the expansion of the valve seat may still be limited, e.g., to avoid the valve seat expanding beyond the expanded diameter of the valve to be placed at the valve seat or beyond the diameter to fixedly retain the valve in the valve seat by forces generated therebetween. The valve seat 18 may be part of or define the body of the docking station 10, or the valve seat 18 may be a separate member attached to the body of the docking station. The valve seat 18 may be longer, shorter, 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 sealing line between the valve 29 and the docking station.

The one or more sealing portions 410 of various embodiments may take a wide variety of different forms. For example, the one or more sealing portions 410 may be any structure that provides one or more seals between the docking station 10 and the surface 416 of the circulation system. For example, one or more sealing portions 410 may comprise fabric, foam, biocompatible tissue, combinations of these, and the like. The one or more sealing portions 410 may be part of the body of the docking station 10 or define the body of the docking station 10, and/or the one or more sealing portions 410 may be a separate member 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.

As described above, in an exemplary embodiment, one or more sealing portions 410 are configured to apply a low radially outward force to surface 416. The low radially outward force can be provided in a wide variety of different ways. For example, the sealing portion may be made of a very compressible or very compliant material. Referring to FIG. 7C, in one exemplary embodiment, the docking station 10 body is made of an elastic or super-elastic metal. One such metal is nitinol. Where the body of the docking station 10 is made of a grid of metal posts, the body may have a spring characteristic. Referring to fig. 7C, like the spring, the body of the docking station exerts little or no radially outward force when the body of the docking station is unconstrained and allowed to relax to its maximum diameter. As the main body of the docking station 10 is compressed, the radially outward force exerted by the docking station increases, like a spring. As illustrated in fig. 7C, in one exemplary embodiment, the relationship of the radially outward force of the docking station body to the expanded diameter of the docking station is non-linear, although in one exemplary embodiment, the relationship may also be linear. In the example illustrated in fig. 7C, curve 750 illustrates the relationship between the radially outward force exerted by the docking station 10 and the compressed diameter of the docking station. In region 752, curve 750 has a low slope. In this region 752, the radially outward force is low and varies only by a small amount. In an exemplary embodiment, the area 752 corresponds to a diameter of between 25mm and 40mm, such as between 27mm and 38 mm. The radially outward force in region 752 is small but not zero. In region 754, curve 750 has a higher slope. The radially outward force in this area 754 increases significantly with compression of the docking station. In an exemplary embodiment, the body of the stent is built in the low slope region 752. This allows the sealing portion 710 to apply only a small radially outward force to the inner surface 416 of the circulatory system over a wide range of diameters.

The retaining portion 414 may take a wide variety of different forms. For example, the one or more retaining portions 414 may be any structure that sets the position of the docking station 10 in the circulatory system. For example, the one or more retaining portions 414 may press against the inner surface 416 or into the inner surface 416 or extend around the anatomy of the circulatory system to set the position of the docking station 10. The one or more retaining portions 414 may be part of or define the body of the docking station 10 or the one or more retaining portions 414 may be separate members attached to the body of the docking station. The docking station 10 may include a single retaining portion 414 or two or more retaining portions.

Fig. 10A-10C illustrate that the docking station 10 may have any combination of one or more different types of valve holders 18 and sealing portions 410. In the example illustrated in fig. 10A, the valve seat 18 is a separate member 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 illustrated in fig. 10B, the valve seat 18 is a separate member attached to the body of the docking station 10, and the sealing portion 410 is a separate member attached to the body of the docking station. In the example illustrated in fig. 10C, the valve seat 18 is integrally formed with the body of the docking station 10, and the sealing portion is integrally formed with the body of the docking station. In the example illustrated in fig. 10D, the valve seat 18 is integrally formed with the body of the docking station 10, and the sealing portion is a separate member attached to the body of the docking station 10.

As noted above, the length of the pulmonary artery PA and other anatomical structures of the circulatory system may vary greatly from patient to patient. Referring to fig. 11A-11D, in one exemplary embodiment, the length 10 of the docking station is adjustable as indicated by arrow 1100. This adjustability 1100 refers to the ability of the implanted/expanded length of the docking station to be adjusted, rather than the inherent change in length that occurs when the stent expands from a compressed state to an expanded state. The length can be adjusted in a wide variety of different ways. In the example illustrated in fig. 11A-11D, the docking station 10 includes a first half 1102 and a second half 1104. The use of the word "half" herein in relation to a two part docking station is synonymous with "part" and does not require that the first and second halves or the first and second parts are equal in size, i.e., the first half may be larger/longer than the second half, and vice versa. In one embodiment, second half 1104 can be inserted or "telescoped" into first half 1102. The amount of insertion or "nesting" sets the length of the docking station 10. The length of any docking station 10 shown and described in this patent application may be adjusted by making the docking station from two parts that are nested together or otherwise adjustable relative to each other. In one embodiment, the length of the single piece docking station is collapsible and expandable. In one embodiment, the docking station may be formed of a material that can change shape to adjust the length. In one embodiment, more than two portions (e.g., 3, 4, or more portions) may be combined in a similar manner and include one or more features similar to the first half 1102 and the second half 1104.

In one exemplary embodiment, the length of the docking station may be adjusted by first deploying the first half 1102 of the docking station 10 in the pulmonary artery, in the pulmonary artery PA. For example, the first half 1102 may be positioned and expanded as desired, e.g., such that the distal end 1106 of the first half aligns with or extends slightly past the branches of the pulmonary artery. After expanding the first half 1102 in the pulmonary artery, the compressed second half 1104 may be positioned with the distal end 1110 disposed at the proximal end 1108 of the first half 1102. In one embodiment, the position of the second half 1104 is selected such that the sealing portion 410 and the retaining portion 414 will make contact with and set the position of the docking station 10 in the pulmonary artery. Once properly positioned, the second half 1104 is expanded. In one embodiment, the distal end 1110 of the second half 1104 frictionally engages the proximal end 1108 of the first half to secure the two halves 1102, 1104 together. In one embodiment, one or more latches, latching mechanisms, one or more sutures, interweaving, one or more chains, and/or other attachment devices/mechanisms may be used to assist in securing the halves/portions together.

In the example illustrated in fig. 11A-11D, the seat 18 and sealing portion 410 are included on the second half 1104 of the docking station 10. However, in other embodiments, the seat 18 and/or the sealing portion 410 may be included on the first half 1102. Fig. 11A-11C illustrate that the halves 1102, 1104 of the docking station 10 may have any combination of different types of valve holders 18 and sealing portions 410. In the example illustrated in fig. 11A, the valve seat 18 is a separate member attached to the body of the docking station half 1104, and the sealing portion is integrally formed with the body of the docking station half 1104. In the example illustrated in fig. 11B, the valve seat 18 is a separate member attached to the body of the docking station half 1104, and the sealing portion 410 is a separate member attached to the body of the docking station half 1104. In the example illustrated in fig. 11C, the valve seat 18 is integrally formed with the body of the docking station half 1104, and the sealing portion is integrally formed with the body of the docking station half 1104. In the example illustrated in fig. 11D, the valve seat 18 is integrally formed with the body of the docking station half 1104, and the sealing portion 410 is a separate member attached to the body of the docking station half 1104.

Fig. 12A-12D illustrate an exemplary embodiment of a docking station 10 having two sealing portions 410. The docking station 10 may have any combination of one or more than one different types of valve holders 18 and sealing portions 410. In the example illustrated in fig. 12A, the valve seat 18 is a separate member attached to the body of the docking station 10, and the sealing portion 410 is integrally formed with the body of the docking station. In the example illustrated in fig. 12B, the valve seat 18 is a separate member attached to the body of the docking station 10, and the sealing portion 410 is a separate member attached to the body of the docking station. In the example illustrated in fig. 12C, the valve seat 18 is integrally formed with the body of the docking station 10 and the sealing portion is integrally formed with the body of the docking station. In the example illustrated in fig. 12D, the valve seat 18 is integrally formed with the body of the docking station 10, and the sealing portion is a separate member attached to the body of the docking station 10.

Fig. 13A-13D illustrate that the docking station illustrated in fig. 12A-12D may be a two-piece (two-piece) telescoping docking station. The pieces 1102, 1104 of the docking station 10 may have any combination of one or more than one different type of valve seat 18 and sealing portion 410 on one or both of the pieces. In the example illustrated in fig. 13A, the first half 1102 includes the integral sealing portion 410. The second half 1104 includes the valve seat 18, which is a separate member attached to the body of the docking station 10, and the sealing portion 410 is integrally formed with the body of the docking station. In the example illustrated in fig. 13B, the first half 1102 includes a sealing portion 410 that is separate from the body of the first half 102. The valve seat 18 is a separate member attached to the body of the docking station 10, and the sealing portion 410 is a separate member attached to the body of the docking station. In the example illustrated in fig. 13C, the first half 1102 includes the 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 illustrated in fig. 12D, the first half 1102 includes the sealing portion 410 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 member attached to the body of the second half 1104.

Referring to fig. 14A-14G, in one exemplary embodiment, the docking station 10 may include a permeable portion 1400 through which blood may flow as indicated by arrow 1402 and an impermeable portion 1404 through which blood may not flow. In an exemplary embodiment, the impermeable portion 1404 extends from at least the sealing portion 410 to the valve seat 18 to prevent blood flow around the valve 29. In an exemplary embodiment, the permeable portion 1400 allows blood to flow freely therethrough such that the portion that does not seal against the inner surface 416 of the circulatory system or against the docking station of the valve 29 does not block 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 is free to allow blood to flow through the docking station 10. In an exemplary embodiment, the permeable portion 1400 allows blood to flow freely therethrough such that an area 1420 between the docking station and the circulatory system is flushed with blood as the heart beats, thereby preventing blood from stagnating in the area 1420.

The impermeable portion 1404 can take a wide variety of different forms. The impermeable portion 1404 can be any structure or material that prevents blood from flowing through the impermeable portion 1404. For example, the body of the docking station 10 may be formed from a wire or mesh, such as nitinol wire or mesh, and the chamber of the body is covered by an impermeable material (see fig. 18). A wide variety of different materials may be used as the impermeable material. For example, the impermeable material can be a blood impermeable cloth, such as PET cloth, or a biocompatible covering material such as fabric treated with a blood impermeable coating, polyester, or a processed biological material such as pericardium.

Fig. 14A-14G illustrate that a wide variety of docking station configurations may be provided with a permeable section 1402. The sealing portion 410 may be integrally formed with the body of the docking station as illustrated in fig. 14B, 14D, and 14F, or separate as illustrated in fig. 14C, 14E, and 14G. In fig. 14F and 14G, the docking station 10 includes a portion 1410. These portions 1410 are similar to the sealing portion 410, but do not form a seal with the inner surface 416 of the circulation system, as the portions 1410 are part of the permeable portion 1402. The valve seat 18 may be formed separately from the body of the docking station as illustrated in fig. 14A-14C, or integrally with the body of the docking station 10 as illustrated in fig. 14D-14G.

Fig. 15A, 15B, 16, 17A, and 17B illustrate an exemplary embodiment of a body of the frame 1500 or docking station 10. The frame 1500 or body can take a wide variety of different forms, and fig. 15A, 15B, 16, 17A, and 17B illustrate only one of a variety of possible configurations. In the example illustrated in fig. 15A, 15B, 16, 17A, 17B, and 18, the docking station 10 has relatively wide proximal and distal inflow ends 12, 14, and a relatively narrow portion 16 forming a seat 18 between the ends 12, 14. In the example illustrated in fig. 15A, 15B, 17A, and 17B, the frame 1500 of the docking station 10 is preferably a wide cradle made up of a plurality of metal struts 1502 forming chambers 1504. In the example of fig. 15A, 15B, 17A, and 17B, the frame 1500 has a generally hourglass shape with a narrowed portion 16, the narrowed portion 16 forming a valve seat 18 when covered by an impermeable material between the proximal end 12 and the distal end 14. As described below, the valve 18 extends in the stenosed portion 16 forming a valve seat 18.

Fig. 15A, 15B, 17A, and 17B illustrate the frame 1500 in its unconstrained, expanded condition. In this exemplary embodiment, the retaining portion 414 includes ends 1510 of the metal struts 1502 at the proximal end 12 and the distal end 14. The sealing portion 410 is between the holding portion 414 and the waist portion 16. In an unconstrained condition, the retention portion 414 extends generally radially outward and radially outward of the sealing portion 410. Fig. 16 illustrates the frame 16 in a compressed state for delivery and expansion through a catheter. The docking station may be made of a very elastic or very compliant material to accommodate large changes in the anatomy. For example, the docking station may be made of a highly flexible metal, metal alloy, polymer, or open cell foam. An example of a highly elastic metal is nitinol, but other metals and highly elastic or highly compliant non-metallic materials may be used. The docking station 10 may be self-expanding, may be manually expandable (e.g., expandable by a balloon), or may be mechanically expandable. The self-expanding docking station 10 may be made of a shape memory material such as, for example, nitinol.

Fig. 18 illustrates a frame 1500 with an impermeable material 21 attached to the frame 1500 to form the docking station 10. Referring to FIG. 18, in one exemplary embodiment, the band 20 extends around or is integral with the waist or narrow portion 16 to form a non-expandable or substantially non-expandable valve seat 18. The strap 20 stiffens the waist and, once deployed and expands the docking station, makes the waist/valve seat relatively inextensible in its deployed configuration. In the example illustrated in fig. 19, the valve 29 is secured by its collapsible frame expanding into the stenotic portion 16 of the docking station 10 forming the valve seat 18. As explained above, the non-expandable or substantially non-expandable valve seat 18 prevents radially outward forces of the valve 29 from being transferred to the inner surface 416 of the circulatory system. In yet another exemplary embodiment, the waist/valve seat of the deployed docking station may optionally expand slightly in an elastic fashion (washion) when the valve is deployed against it. This optional elastic expansion of the waist 18 may exert pressure on the valve 29 to assist in holding the valve 29 in place within the docking station.

The strip may take a wide variety of different forms and may be made from a wide variety of different materials. The strip 20 may be made of: PET, one or more sutures, fabric, metal, polymer, biocompatible tape (tape), or other relatively inextensible material known in the art sufficient to maintain the shape of the valve seat 18 and hold the valve 29 in place. The band may extend around the exterior of the stent, or may be an integral part thereof, such as when a fabric or another material is interwoven into or through the chambers of the stent. The strip 20 may be narrow, as in the suture strip of fig. 18, or may be wider. The strips may be of various widths, lengths, and thicknesses. In one non-limiting example, the width of the valve seat 18 is between 27-28mm, although the diameter of the valve seat should be within the operational range of the particular valve 29 to be secured within the valve seat 18, and may differ from the previous examples. When docked in the docking station, the valve 29 may optionally expand slightly around either side of the valve seat. This aspect, sometimes referred to as "dog bone" (e.g., due to its shape formed around the valve seat or band), may also assist in holding the valve in place.

Fig. 20 and 21 illustrate the docking station 10 of fig. 18 implanted in a circulatory system, such as in 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 fig. 20 and 21, the sealing portion 410 is formed by providing an impermeable material 21 (see fig. 21) over the frame 1500 or a portion thereof, and in particular, the sealing portion 410 may include a lower, rounded, radially outwardly extending portion 2000 of the frame 1500. In an exemplary embodiment, the impermeable material 21 extends from at least a 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 to the outflow direction 14 is directed to the valve seat 18 (and the valve 29 once installed or deployed in the valve seat).

In a preferred embodiment of the docking station 10, the inflow portion has walls that are impermeable to blood, but the outflow portion walls are relatively open. In one approach, portions of the inflow end portion 12, the intermediate section 16, and the outflow end portion 14 are covered with a blood impermeable fabric 21, which may be sewn onto the stent or otherwise attached by methods known in the art. The impermeability of the inflow portion of the stent assists the blood in funneling into the docking station 10 and eventually flowing through the valve to be expanded and secured within the docking station 10.

From another perspective, this embodiment of the docking station is designed to seal at the proximal inflow section 2000 to create a conduit for blood flow. However, the distal outflow section remains generally open, allowing the docking station 10 to be placed higher in the pulmonary artery without restricting blood flow. For example, the permeable portion 1400 may extend into a branch of the pulmonary artery and not obstruct or not significantly obstruct blood flow through the branch. In one embodiment, a blood impermeable cloth, such as, for example, PET cloth, or other material covers the proximal inflow section, but the cover does not cover any of the distal outflow section 14 or at least part of the distal outflow section 14. As one non-limiting example, when the docking station 10 is placed in a pulmonary artery, which is a large blood vessel, a significant volume of blood flowing through the artery enters the valve 29 through the fabric covering 21 in a funneling manner. The fabric 21 is fluid impermeable so that blood cannot pass through. Again, various other biocompatible covering materials may be utilized, such as, for example, foam or fabric treated with a coating that is impermeable to blood, polyester, or processed biological material such as pericardium.

In the example illustrated in fig. 21, the docking station frame 1500 is further provided with an impermeable material 21, forming a relatively large impermeable portion 1404. In the example illustrated in fig. 21, the impermeable portion 1404 extends from the inflow end 12 and terminates in a row of chambers 1504 before the outflow end. Thus, the most distal row of chambers 1504 forms the permeable section 1400. However, more rows of chambers 1504 may not be covered by impermeable material to form larger permeable sections. Permeable portion 1400 allows blood to flow into region 2130 and out of region 2130 as indicated by arrows 2132. With respect to the inflow end 12, it should be noted that because the chamber 1504 is generally diamond shaped, blood is able to flow between the docking station 10 and the surface 416 until reaching the sealing portion 410. That is, in one exemplary embodiment, blood can flow into region 2100 and out of region 2100.

The valve seat 18 may provide a support surface for implantation or deployment of the valve 29 in the docking station 10. The retaining portion 414 may retain the docking station 10 in an implanted or deployed position in the circulatory system. The exemplary retention portion has an outwardly curved flared portion (flare) that assists in securing the docking station 10 within the artery. As used herein, "outward" means extending away from the central longitudinal axis of the docking station. As can be seen in fig. 20, the retaining portion 414 engages the surface 416 at an angle a (tangent to the normal to the surface to the midpoint of the surface of the retaining portion 414) that may be between 30 and 60 degrees, such as about 45 degrees, when the docking station 10 is compressed by the inner surface 416, rather than extending substantially radially outward (i.e., a is 0 to 20 degrees or about 10 degrees) as in the uncompressed condition (see fig. 15B). This inward bending of the retaining portion 414, as indicated by arrow 2020, serves to retain the docking station 10 in the circulatory system. The retention portion 14 is at the wider inflow end portion 12 and outflow end portion 14 and presses against the inner surface 416. The flared retention portion 414 engages into surrounding anatomical structures in the circulatory system, such as the pulmonary artery (pulmonic) space. In one exemplary embodiment, the flared portion acts as a stop that locks the device in place. Upon application of an axial force to the docking station 10, the flared retention portion 414 is forced into the surrounding tissue to resist movement of the stent, as described in more detail below. In certain embodiments, the docking station has an overall hourglass shape with wider distal and proximal portions having flared retention portions and a narrowed, banded waist between the ends into which the valve is expanded.

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

The valve 29 can be delivered to the site of the docking station by conventional means, such as by balloon or mechanical expansion or by self-expansion. When the valve 29 is expanded, it nests in the valve seat of the docking station 10. In one embodiment, the banded waist is slightly elastic and exerts a spring force on the valve 29 to assist in holding the THV in place.

Fig. 23A and 23B illustrate that the docking station 10 may be used to accommodate a variety of different sizes of circulatory system anatomy for implantation of a valve 29 having a consistent size. In the example of fig. 23A and 23B, the same size docking station 10 is deployed in two different sized blood vessels 2300, 2302, such as two different sized pulmonary arteries PA. In an example, the vessel 2300 illustrated in fig. 23A has a larger effective diameter than the vessel 2302 illustrated in fig. 23B. (Note that the dimensions of the anatomy of the circulatory system in this patent application are referred to by the terms "diameter" or "effective diameter". An anatomy of the circulatory system is not generally circular. the terms "diameter" and "effective diameter" herein refer to the diameter of a circle or disc that can be deformed to fit within a non-circular anatomy.) in the example illustrated in FIGS. 23A and 23B, the sealing portion 410 and the retaining portion 414 conform to contact each of the blood vessels 2300, 2302. However, the valve seat 18 remains the same size, although the sealing portion 410 and the retaining portion 414 are compressed. In this manner, the docking station 10 accommodates a wide variety of different anatomical sizes to implant a standard or single size valve. For example, the docking station may conform to vessel diameters of 25mm and 40mm, such as 27mm and 38mm, and provide a constant or substantially constant diameter valve seat of 24mm to 30mm, such as 27mm to 28 mm. However, the valve seat 10 may be adapted for applications where the vessel diameter is greater or less than 25mm to 40mm and provides a valve seat of greater or less than 24mm to 30 mm.

Referring to fig. 23A and 23B, the strap 20 maintains a constant or substantially constant diameter of the valve seat 18 even as the proximal and distal ends of the docking station expand to the respective diameters required for engagement with the inner surface 416. The diameter of the pulmonary artery PA can vary greatly from patient to patient, but the valve seat 18 in the deployed configuration always has a diameter that is within an acceptable range for the valve 29.

Fig. 24 and 25 illustrate side profiles of the docking station 10 illustrated in fig. 18 when implanted in different sized vessels 2300, 2302 of the circulatory system, the schematic example transcatheter heart valve 29 having the same dimensions mounted or deployed in each docking station 10. In this example, the docking stations 10 all receive blood vessels 2300, 2302 having a variety of different sizes and act as isolators that prevent or substantially prevent radially outward forces of the valve 29 from being transferred to the vessels. The valve seat 18 is not expanded radially outward by the radially outward force of the valve 29 or is not substantially expanded radially outward by the radially outward force of the valve 29, and the anchoring/retaining portion 414 and sealing portion 410 impart only a relatively small radially outward force on the vessel 2300, 2302 (as compared to the radially outward force applied by the valve 29 to the valve seat 18), even when the docking station is deployed in a vessel 2302 having a smaller diameter.

In the example illustrated in fig. 24 and 25, the holder or frame 712 of the valve 29 is expanded or is expanded radially outward to input a high force 710 on the valve seat 18 of the docking station 10. This high radially outward force 710 secures the valve 29 to the valve seat 18 of the docking station 10. However, because the valve seat 18 is not expanded by the force 710 or is not substantially expanded by the force 710, the force 710 is isolated from the circulatory system and is not used to secure the docking station in the circulatory system.

In an exemplary embodiment, the radially outward force 722 of the sealing portion 410 against both the larger vessel 2300 and the smaller vessel is substantially less than the radially outward force 710 applied by the valve 29 to the valve seat 18. For example, for the smallest vessel that the docking station 10 for valve implantation will accommodate, the radially outward sealing force 722 may be less than 1/2, less than 1/3, less than 1/4, less than 1/8, or even less than 1/10 of the radially outward force 710 applied by the valve. In an exemplary embodiment, the radially outward force 722 of the sealing portion 410 is selected to provide a seal between the inner surface 416 and the sealing portion 410, but is insufficient to maintain the position of the valve 29 and docking station 10 in the circulatory system by itself. In one embodiment, the radially outward force 722 is sufficient to maintain the position of the valve 29 and docking station 10 in the circulatory system.

In an exemplary embodiment, the docking station 10 illustrated in fig. 18 further includes an anchoring/retaining portion 414 that exerts a substantially smaller radially outward force 720 than the radially outward force 710 exerted by the valve 29 against the valve seat 18. For example, for the smallest vessel that the docking station 10 for valve implantation will accommodate, the radially outward sealing force 720 may be less than 1/2 of the radially outward force 710 exerted by the valve, less than 1/3 of the radially outward force 710 exerted by the valve, less than 1/4 of the radially outward force 710 exerted by the valve, less than 1/8 of the radially outward force 710 exerted by the valve, or even less than 1/10 of the radially outward force 710 exerted by the valve. In one embodiment, the radially outward force 720 of the anchoring/retaining portion 414 is insufficient to retain the position of the valve 29 and docking station 10 in the circulatory system by itself. In one embodiment, the radially outward force 720 is sufficient to maintain the position of the valve 29 and docking station 10 in the circulatory system.

In an exemplary embodiment, the frame 1500 of the docking station 10 is made of an elastic or superelastic material or metal. One such metal is nitinol. When the frame 1500 of the docking station 10 is made of a grid of metal posts, the body may have a spring characteristic. Referring to fig. 7C, like the springs, the frame of the docking station 10 illustrated in fig. 24 and 25 exerts little or no radially outward force when the frame 1500 is unconstrained and allowed to relax to its maximum diameter. As the frame 1500 of the docking station 10 is compressed, the radially outward force exerted by the docking station increases, like a spring. As illustrated in fig. 7C, in one exemplary embodiment, the relationship of the radially outward force of the docking station frame 1500 to the expanded diameter of the docking station is non-linear, although it may also be linear. In the example illustrated in fig. 7C, curve 750 illustrates the relationship between the radially outward force exerted by the docking station 10 and the compressed diameter of the docking station. In region 752, curve 750 has a low slope. In this region 752, the radially outward force is low and varies only by a small amount. In an exemplary embodiment, the area 752 corresponds to a diameter of between 25mm and 40mm, such as between 27mm and 38 mm. The radially outward force in region 752 is small but not zero. In region 754, curve 750 has a higher slope. In this area 754, the radially outward force increases significantly as the docking station is compressed. In one exemplary embodiment, the body of the stent is constructed in a low slope region 752 for both the largest vessel 2300 (fig. 24) and the smallest vessel 2302 (fig. 25) accommodated by the docking station 10. This allows the sealing portion 710 to apply only a small radially outward force to the inner surface 416 of the circulatory system over a wide range of diameters.

Fig. 26A-26C illustrate the docking station 10 of fig. 18 implanted in a pulmonary artery. Fig. 26A illustrates the outline of the docking station 10 implanted in the pulmonary artery PA. Fig. 26B illustrates the outline of the docking station 10 implanted in the pulmonary artery PA with the schematically illustrated valve 29 mounted or deployed in the docking station 10. Fig. 26C illustrates the docking station 10 and valve 29 depicted in fig. 22 implanted in a pulmonary artery PA. As mentioned in relation to fig. 2A-2E and 3A-3D, the shape of the pulmonary artery may vary significantly along its length. In one exemplary embodiment, the docking station 10 is configured to conform to the changing shape of the pulmonary artery PA. The docking station 10 is illustrated as being positioned below a pulmonary artery bifurcation or branch. However, typically the docking station 10 will be positioned such that the tip 14 extends into the pulmonary artery bifurcation 210. When it is contemplated that the docking station 10 will extend into a pulmonary artery bifurcation, the docking station 10 may have a blood permeable portion 1400 (e.g., as shown in fig. 21).

FIG. 27 illustrates another exemplary embodiment of the docking station 10. The docking station 10 includes a frame 2700 and an outer seal portion 410. The frame 2700 or body can take a wide variety of different forms, and fig. 27 illustrates only one of many possible configurations. In the example illustrated in fig. 27, the docking station 10 has relatively wide proximal and distal inflow ends 12, 14, and an elongated, relatively narrow portion 2716. The seat 18 and sealing portion 410 may be provided anywhere along the length of the elongated, relatively narrow portion 2716. In the example illustrated in fig. 27, the frame 2700 of the docking station 10 is preferably a cradle made up of a plurality of metal struts 1502 that form a chamber 1504. Frame 2700 or one or more portions of the frame can optionally be covered by impermeable material 21 (e.g., as shown in fig. 18).

Fig. 27 illustrates frame 2700 and sealing portion 410 in their unconstrained, expanded condition/configuration or deployed configuration. In this exemplary embodiment, the retaining portion 414 includes ends 1510 of the metal struts 1502 at the proximal end 12 and the distal end 14. The sealing portion 410 may be a separate member disposed around the frame 2700 between the holding portions 414. The retaining portion 414, in an unconstrained condition, extends generally radially outward and may be radially outward of the sealing portion 410.

The docking station 10 illustrated in fig. 27 may be made of a very elastic or very compliant material to accommodate large changes in anatomy. For example, the docking station may be made of highly flexible metal (e.g., the frame in the example of fig. 27) and cloth and/or open-cell foam (e.g., the sealing portion in the example of fig. 27). An example of a highly elastic metal is nitinol, but other metals and highly elastic or highly compliant non-metallic materials may be used. Examples of open-cell foams that can be used are biocompatible foams, such as polyurethane foams (e.g., as available from Biomerix, Rockville, MD). In one embodiment, the foam forming the sealing portion may also form a valve seat on its inner surface.

Still referring to fig. 27, the frame 2700 and/or the separate sealing portion 410 can include optional straps 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 region of the valve seat 18 without the use of the band 20. Optional straps 20 stiffen the frame 2700 and/or the sealing portion and make the valve seat relatively inextensible.

The optional strap 20 can take 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 straps discussed elsewhere in this disclosure. The strip 20 may be made of: PET, one or more sutures, fabric, metal, polymer, biocompatible band, or other relatively inextensible material known in the art sufficient to maintain the shape of the valve seat 18 and hold the valve 29 in place. The band may extend around the exterior of the stent or may be an integral part thereof, such as when a fabric or another material is interwoven into or through the chambers of the stent. The strip 20 may be narrow, as in the suture strip of fig. 18, or wider as shown in phantom in fig. 27. In one non-limiting example, the diameter of the valve seat 18 is between 27-28mm, although the diameter of the valve seat should be within the operational range of the particular valve 29 to be secured within the valve seat 18 and may differ from the previous examples.

FIGS. 28 and 29 illustrate a modified version of the docking station 10 illustrated in FIG. 27 that is expandable in length. As noted above, the length of the pulmonary artery PA and other anatomical structures of the circulatory system may vary greatly from patient to patient. Referring to fig. 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, it may be adjusted in any of the ways described elsewhere in this disclosure. In the example illustrated in fig. 28 and 29, the docking station 10 includes a first half 1102 and a second half 1104. The second half 1104 may be inserted or "nested" into the first half 1102. The amount of insertion or "nesting" sets the length of the docking station 10.

In one exemplary embodiment, the length of the docking station 10 is adjusted in the pulmonary artery PA by first deploying the first half 1102 of the docking station 10 in the pulmonary artery. For example, the first half 1102 may be positioned and expanded such that the distal end 1106 of the first half is aligned with or extends slightly past the branches of the pulmonary artery. After expanding the first half 1102 in the pulmonary artery, the compressed second half 1104 is positioned with the distal end 1110 disposed at 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 will make contact with the pulmonary artery and will set the position of the docking station 10 in the pulmonary artery. Once properly positioned, the second half 1104 is expanded. The distal end 1110 of the second half 1104 frictionally engages the proximal end 1108 of the first half to secure the two halves 1102, 1104 together. In one embodiment, one or more latches, latching mechanisms, one or more sutures, interweaving, one or more chains, and/or other attachment devices/mechanisms (also or alternatively) may be used to secure the two halves together.

In the example illustrated in fig. 28 and 29, the seat 18 and sealing portion 410 are included on a first half 1102 of the docking station 10. However, in other embodiments, the seat 18 and/or one or more sealing portions 410 may be included on the second half 1104 or in different locations on the first half and/or the second half.

Fig. 30 and 31A illustrate the docking station 10 of fig. 27 and 28 and 29 implanted in a circulatory system, such as a pulmonary artery PA. The sealing portion 410 provides a seal between the docking station 10 and the inner surface 416 of the pulmonary artery PA. In the example of fig. 30 and 31A, sealing portion 410 is an expanding material, such as an expandable open cell foam over frame 2700. In an exemplary embodiment, the sealing portion 410 coincides with, or at least overlaps, the valve seat 18. When the sealing portion 410 does not overlap the valve seat 18, an impermeable material 21 may be provided over portions of the frame (e.g., from the sealing portion 410 to the valve seat 18 to make a docking station impermeable from the sealing portion 410 to the valve seat 18). Regardless of whether the sealing portion 410 overlaps the valve seat 10 or an impermeable material is provided from the sealing portion 410 to the valve seat 18, all blood flowing in the inflow direction 12 to the outflow direction 14 is directed to the valve seat 18 (and the valve 29 once installed or deployed in the valve seat).

In an exemplary embodiment of the docking station 10, at least the outflow portion 14 of the frame 2700 is relatively open. Referring to fig. 31A, this allows the docking station 10 to be placed in a high position in the pulmonary artery without restricting blood flow. For example, the open chamber 1504 may extend to a branch or bifurcation of a pulmonary artery and not obstruct or not significantly obstruct blood flow through the branch. The open chamber 1504 allows blood to flow through the frame 1500 as indicated by arrow 3132 in fig. 31A.

In the example illustrated in fig. 30 and 31A, the docking station 10 is retained in the pulmonary artery PA by expanding one or more retaining portions 414 radially outward into the region 210, 212 of the pulmonary artery PA in which the inner surface 416 also extends outward. For example, the retention portion 414 may be configured to extend radially outward into the pulmonary artery bifurcation 210 and/or the opening 212 of the pulmonary artery leading to the right ventricle RV. In one exemplary embodiment, the docking station 10 may be an adjustable docking station. For example, the docking station 10 may be a telescoping docking station as illustrated in fig. 28, and the first portion 1102 is deployed such that the retaining portion 414 extends radially outward into the pulmonary artery bifurcation 210). The second portion 1104 may then be positioned in the first portion 1102 such that its remaining portion 414 coincides with the ostium of the pulmonary artery or another outwardly extending region of the pulmonary artery. Once in place, the second portion 1104 may be expanded to secure the second section 1104 to the first section 1102 and to the pulmonary artery at the opening 212 or other outwardly extending region.

Referring to fig. 31B, the valve holder 18 provides a support surface to mount or deploy the valve 29 in the docking station 10. The valve may be installed or deployed in the valve seat using the steps disclosed herein or elsewhere in this disclosure. The anchoring/retaining portion 414 maintains the docking station 10 in an implanted or deployed site/position in the circulatory system. After deployment of the docking station 10, the valve 29 is in a compressed form and may be introduced into the valve seat 18 of the docking station 10. The valve 29 may be expanded in the docking station such that the valve 29 engages the valve seat 18. The valve 29 may be delivered to the site of the docking station by conventional means, such as by balloon or mechanical expansion, or by self-expansion. When the valve 29 is expanded, it nests in the valve seat of the docking station 10.

Referring to fig. 32A, the docking station illustrated in fig. 18 is deployed in the pulmonary artery PA of the heart H. Fig. 32B illustrates a generic example valve 29 deployed in the docking station 10 illustrated in fig. 32A. In fig. 32A and 32B, the heart is in systole. Fig. 33A is an enlarged representation of docking station 10 and valve 29 in pulmonary artery 29 of fig. 32B. The valve 29 is open when the heart is in systole. Blood flows from the right ventricle RV as indicated by arrow 3202 and through the pulmonary artery PA, docking station 10, and valve 29. Fig. 33B illustrates a space 3208 indicating the opening of the valve 29 when the heart is in systole. Fig. 33B does not show the interface between the docking station 10 and the pulmonary artery to simplify the drawing. The cross-hatching in fig. 33B illustrates blood flow through an open valve. In an exemplary embodiment, blood is prevented from flowing between the pulmonary artery PA and the docking station 10 by the seal 410 and from flowing between the docking station 10 and the valve 29 by the seating of the valve 29 in the seat 18 of the docking station 10. In this example, blood flows substantially only or only through the valve 29 when the heart is in systole.

Fig. 34 illustrates the valve 29, docking station 10, and heart H of the example of fig. 32B when the heart is in diastole. Referring to fig. 34, the valve 29 is closed when the heart is in diastole. Fig. 35A is an enlarged representation of docking station 10 and valve 29 in pulmonary artery 29 of fig. 34. Blood flow in the pulmonary artery PA above the valve 29 (i.e., in the pulmonary artery branch 210) is blocked by the valve 29 being in a position to close and block blood flow as indicated by arrow 3400. The solid area 3512 in fig. 35B indicates that the valve 29 is closed when the heart is in diastole.

Referring to fig. 33A, the radially outward force 720 of anchoring/retaining portion 414 against inner surface 416 is substantially less than the radially outward force 710 applied by valve 29 against valve seat 18. For example, the radially outward sealing force 720 may be less than 1/2 of the radially outward force 710 applied by the valve, less than 1/3 of the radially outward force 710 applied by the valve, less than 1/4 of the radially outward force 710 applied by the valve, less than 1/8 of the radially outward force 710 applied by the valve, or even less than 1/10 of the radially outward force 710 applied by the valve.

Referring to fig. 33A and 35A, in an exemplary embodiment, the radially outward force 720 of the retaining portion 414 is insufficient to retain the position of the valve 29 and docking station 10 in the circulatory system by itself. Instead, the pressure of the blood 3208 acts to enhance retention of the retaining portion 414 to the inner surface 416. Referring again to fig. 33A, when the heart is in systole, the valve 29 is open and blood flows through the valve as indicated by arrows 3202. With the valve 29 open and blood flowing through the valve 29, the pressure P exerted by the blood on the docking station 10 and the valve 29 is low as indicated by the small P and arrows in fig. 33A. Although small, the pressure P forces the docking station and its upper retaining portion 414 against the surface 416 generally in the direction indicated by arrow F (small F representing a relatively low force). This blood flow assisted force F applied by the retaining portion F to the surface 416 prevents the docking station 10 and valve 29 from moving in the direction of blood flow 3302 during systole of the heart H.

Referring to fig. 35A, while the heart is in diastole, the valve 29 is closed and blood flow is blocked as indicated by arrow 3400. Since the valve 29 is closed and the valve 29 and docking station 10 block blood flow, the pressure P exerted by the blood on the docking station 10 and valve 29 is high as indicated by the large arrow P in fig. 35A. This large pressure P forces the lower retaining portion 414 against the surface 416 generally in the direction indicated by the large arrow F (large F represents a relatively greater force). This blood flow assisted force F applied by the retaining portion F to the surface 416 prevents the docking station 10 and valve 29 from moving in the direction indicated by arrow 3400.

Referring to fig. 33A and 35A, since the force applied by the upper and lower retaining portions 414 depends on the amount of pressure applied by the blood to the valve 29 and docking station 10, the force applied to the surface 416 is automatically proportional. That is, the force with which the upper retaining portion presses against surface 416 when the heart is in systole is less than the force with which the lower retaining portion presses against surface 416 when the heart is in diastole. This is because the pressure against the open valve 29 and docking station 10 during systole is less than the pressure against the closed valve and docking station during diastole.

Methods of treating a patient (e.g., methods of treating heart valve dysfunction/regurgitation/etc.) may include various steps, including steps related to introducing and deploying the docking station in a desired location/treatment area and introducing and deploying the valve in the docking station. For example, fig. 36A illustrates the docking station illustrated in fig. 18 deployed through a catheter 3600. The docking station 10 may 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 path leading to the pulmonary artery may be used. In an exemplary embodiment, the guidewire and, subsequently, catheter 3600 is advanced to the pulmonary artery PA by way of the femoral vein, inferior vena cava, tricuspid valve, and right ventricle RV. The docking station 10 may be placed in the right ventricular outflow tract/pulmonary artery PA to create an artificial catheter and landing zone for the valve 29 (e.g., transcatheter heart valve).

Referring to fig. 36B, the docking station illustrated in fig. 18 is deployed in the Pulmonary Artery (PA) of the heart H. Fig. 36C illustrates the valve 29 deployed in the docking station 10 illustrated in fig. 32A. In the example illustrated in fig. 36C, 37A, 38, 39A, and 39B, the valve 29 is depicted as SAPIEN 3THV provided by Edwards Lifesciences; however, various other valves may be used. In fig. 36A-36C, the heart is in systole. Fig. 37A is an enlarged representation of docking station 10 and valve 29 in pulmonary artery 29 of fig. 36C. When the heart is in systole, the valve (e.g., the Sapien 3 valve) is open. Blood flows from the right ventricle RV and through the pulmonary artery PA, docking station 10, and valve as indicated by arrow 3202. Fig. 37B illustrates a space 3208 representing the valve open when the heart is in systole. Fig. 37B does not show the interface between the docking station 10 and the pulmonary artery to simplify the drawing. The cross-hatching in fig. 37B illustrates blood flow through the valve. In an exemplary embodiment, the seal 410 prevents blood from flowing between the pulmonary artery PA and the docking station 10, and the seating of the valve in the seat 18 of the docking station 10 prevents blood from flowing between the docking station 10 and the valve. In this example, blood flows substantially only or only through the valve when the heart is in the systolic phase.

Fig. 38 illustrates the valve 29, docking station 10, and heart H of the example of fig. 36C when the heart is in diastole. Referring to fig. 38, the valve 29 is closed when the heart is in diastole. Fig. 39A is an enlarged representation of the docking station 10 and valve (e.g., Sapien 3 valve) in the pulmonary artery 29 of fig. 38. Blood flow in the pulmonary artery PA above the valve 29 (i.e., in the pulmonary artery branch 210) is blocked by the valve 29 being in a position to close and block blood flow as indicated by arrow 3400. The solid area 3512 in fig. 39B indicates that the valve 29 is closed when the heart is in diastole.

Referring to fig. 39A, the radially outward force 720 of the anchoring/retaining portion 414 against the inner surface 416 is substantially less than the radially outward force 710 applied by the valve (e.g., Sapien 3 valve) to the valve seat 18. For example, the radially outward sealing force 720 may be less than 1/2 of the radially outward force 710 applied by the valve, less than 1/3 of the radially outward force 710 applied by the valve, less than 1/4 of the radially outward force 710 applied by the valve, less than 1/8 of the radially outward force 710 applied by the valve, or even less than 1/10 of the radially outward force 710 applied by the valve. A 29mm size 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 portions of the deployed docking station described herein may be between about 4 and 16 newtons, although other forces are possible.

Fig. 40A illustrates the docking station illustrated in fig. 27 or 28 deployed through a catheter 3600. Referring to fig. 40B, the docking station illustrated in fig. 27 or 28 is deployed in the pulmonary artery PA of the heart H. Fig. 40C illustrates the valve 29 deployed in the docking station 10 illustrated in fig. 40A. In the example illustrated in fig. 36C, 37A, 38, 39A, and 39B, the valve 29 is SAPIEN 3THV, available from Edwards Lifesciences, although a variety of different valves may be used. In FIGS. 40A-40C, the heart is in systole. Fig. 41A is an enlarged representation of docking station 10 and valve 29 in pulmonary artery 29 of fig. 40C. When the heart is in systole, blood flows from the right ventricle RV and through the pulmonary artery PA, docking station 10, and valve 29 as indicated by arrow 3202. Fig. 41B illustrates a space 3208 representing the opening of the valve 29 when the heart is in systole. Fig. 41B does not show the interface between the docking station 10 and the pulmonary artery to simplify the drawing. The cross-hatching in fig. 41B illustrates blood flow through the valve 29. In an exemplary embodiment, the seal 410 prevents blood from flowing between the pulmonary artery PA and the docking station 10, and the seating of the valve in the seat 18 of the docking station 10 prevents blood from flowing between the docking station 10 and the valve 29. In this example, blood flows substantially only or only through the valve when the heart is in the systolic phase.

Fig. 42 illustrates the valve 29, docking station 10, and heart H of the example of fig. 40C when the heart is in diastole. Referring to fig. 42, the valve 29 is closed when the heart is in diastole. Fig. 43A is an enlarged representation of docking station 10 and valve 29 in pulmonary artery 29 of fig. 42. Blood flow in the pulmonary artery PA above the valve 29 (i.e., in the pulmonary artery branch 210) is blocked by the valve 29 being in a position to close and block blood flow as indicated by arrow 3400. The solid area 3512 in fig. 43B indicates that the valve 29 is closed when the heart is in diastole.

Referring to fig. 43A, the docking station 10 is retained in the pulmonary artery PA by expanding one or more retention/anchoring 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 retention portion 414 may be configured to extend radially outward into the pulmonary artery bifurcation 210 and/or the opening 212 of the pulmonary artery leading to the right ventricle RV. In one exemplary embodiment, the docking station 10 may be an adjustable and/or multi-piece docking station. For example, the docking station 10 may be a telescoping docking station as illustrated in fig. 28, and the first portion 1102 may be deployed such that the retaining portion 414 extends radially outward into the pulmonary artery bifurcation 210, and the second portion 1104 may be positioned in the first portion 1102 such that its retaining portion 414 coincides with the opening 212 of the pulmonary artery. The extension of the retaining portion 414 into the areas 210, 212 sets the position of the docking station 10 in the pulmonary artery PA and helps prevent the pressure P shown in fig. 43A from moving the docking station.

The valve 29 used with the docking station 10 may take a wide variety of different forms. In an exemplary embodiment, the valve 29 is configured to be implanted in the heart H by a catheter. For example, the valve 29 may be expandable and collapsible to facilitate transcatheter administration within the heart. However, in other embodiments, the valve 29 can be configured for surgical administration. Similarly, the docking station described herein may be placed using transcatheter application/placement or surgical application/placement.

Fig. 44-48 illustrate a few examples of the variety of valves or valve configurations that can be used. Some valves that can use any valve type and are traditionally administered surgically can be modified for transcatheter implantation. Fig. 44 illustrates an expandable valve 29 for transcatheter implantation as shown and described in U.S. patent No. 8,002,825, which is incorporated herein by reference in its entirety. An example of a tri-leaflet valve is shown and described in published patent Cooperation treaty application number WO 2000/42950, which is incorporated herein by reference in its entirety. Another example of a tri-leaflet valve is shown and described in U.S. patent No. 5,928,281, which is incorporated herein by reference in its entirety. Another example of a tri-leaflet valve is shown and described in U.S. patent No. 6,558,418, which is incorporated herein by reference in its entirety. Fig. 45-47 illustrate an exemplary embodiment of an expandable tri-leaflet valve 29, such as an Edwards SAPIEN transcatheter heart valve. Referring to fig. 45, in one exemplary embodiment, valve 29 includes a frame 712 including a tri-leaflet valve 4500 (see fig. 46) compressed within frame 712. Fig. 46 illustrates the expanded frame 712 and the valve 29 in an open condition. Fig. 47 illustrates the expanded frame 712 and the valve 29 in a closed condition. Fig. 48A, 48B, and 48C illustrate an example of the expandable valve 29 shown and described in U.S. patent No. 6,540,782 (which is incorporated herein by reference in its entirety). Examples of valves are shown and described in U.S. patent No. 3,365,728, which is incorporated herein by reference in its entirety. Another example of a valve is shown and described in U.S. patent No. 3,824,629, which is incorporated herein by reference in its entirety. Another example of a valve is shown and described in U.S. patent No. 5,814,099, which is incorporated herein by reference in its entirety. Any of these or other valves may be used as the valve 29 in the various embodiments disclosed herein.

Fig. 49A, 49B, and 50A-50D illustrate the distal portion of an exemplary embodiment of a catheter 3600 for delivery and deployment of the docking station 10. The catheter 3600 may take a wide variety of different forms. In the illustrated example, catheter 3600 includes an outer/outer sleeve 4910, an inner/inner 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 connection tube 4916.

The docking station 10 may be disposed within an outer tube/outer sleeve 4910 (see fig. 49B). The elongated leg 5000 may connect the docking station 10 to a docking station connector 4914 (see fig. 49B). The elongated leg 5000 may be a longer retaining portion than the rest of the retaining portion 414. The catheter 3600 may be routed over the guidewire 5002 to position the docking station 10 at the delivery site.

Referring to fig. 50A-50D, the outer tube 4910 is progressively retracted about the inner tube 4912, docking station connector 4914, and elongated nose cone 28 to deploy the docking station 10. In fig. 50A, the docking station 10 begins to expand from the outer tube 4910. In fig. 50B, the distal end 14 of the docking station 10 is expanded from the outer tube 4910. In fig. 50C, the docking station 10 is expanded into the outer tube except that the elongate leg 5000 is still held in the outer tube 4910 by the docking station connector 4914. In fig. 50D, docking station connector 4914 is extended from outer tube 4910 to release leg 5000 to fully deploy the docking station. During deployment of the docking station in the circulatory system, similar steps may be utilized and the docking station may be deployed in a similar manner.

Fig. 51 and 54 illustrate an exemplary embodiment of the nose cone 28. In an exemplary embodiment, the nose cone 28 is an elongated flexible tip or distal end 5110 on a catheter used to assist in feeding the catheter 3600 into the heart. In the illustrated example, the nose cone 28 is a long, tapered cone with a narrow distal end of the cone being relatively flexible. In one non-limiting embodiment, the nose cone has a length of 1.5 inches, and the lumen 5200 of the nose cone 28 has an inner diameter of 0.04 inches to accommodate the guidewire 5002. In one embodiment, the cone becomes progressively stiffer as the diameter of the nose cone 100 increases from a narrow distal end to a wider proximal end. This may be due to the increased thickness and/or the nose cone may be constructed of different materials with different hardnesses (durometers). Optionally, the stiffness of the nose cone at its point of connection with the outer tube 4910 may be substantially the same as the stiffness of the outer tube 4910 in order to prevent abrupt changes in stiffness. In the example illustrated in fig. 51 and 54, the elongate distal end 5110 of the nose cone 28 is the same. In one embodiment, the taper of the nose cone 28 extends the entire length of the nose cone 28 from end to end or only a portion of the length of the nose cone 28. To form the taper, the outer diameter of the nose cone 28 may increase in the distal to proximal direction. The cone may take a variety of shapes and the outer surface of the cone may be at a variety of angles with respect to the longitudinal axis of the nose cone 28.

In an exemplary embodiment, the longer distal end 5110 of the nose cone 28 facilitates navigation around bends or curves in the patient's vasculature. Due to the increased length of the nose cone 28, the tip surrounds the bend more and creates a "follow-the-leader" effect with the rest of the nose cone.

In the example illustrated in fig. 51, the base or proximal end 5112 of the nose cone 28 has a proximal angled portion 5308 adjacent a shelf (shelf) 5310. Upon retrieval of the delivery catheter, the proximal angled portion does not grab a catch (catch) on the docking station 10 that has been implanted in the heart. Thus, the proximal base portion 5112 allows for easier removal of the delivery system. Referring to fig. 53, as angled portion 5308 (or "ramp") of base portion 5112 is retracted into outer tube 4910, ramp 5308 enters the delivery catheter first, followed by shelf 5310. Upon engagement of nose cone 28 with outer sleeve/outer tube 4910, the inner diameter of the outer sleeve rides over ramp 5308 and then rests on shelf 5310 (which may be flat or substantially flat, e.g., 180 ° or 180 ° ± 5 ° with respect to the longitudinal axis of nose cone 28). The inner diameter of outer sleeve/tube 4910 may be slightly smaller than the diameter of shelf 5310 to ensure a slip fit (snug fit).

In one non-limiting example, the shelf 5310 of the nose cone 28 is slip fit into a cavity or outer cavity of the catheter assembly 3600, which in one non-limiting example may have a diameter of about 0.2 inches or between 0.1 inches and 0.4 inches. In one embodiment, the outer diameter of the largest portion of the nose cone 28 may be 0.27 inches or between 0.2 inches and 0.4 inches, with the diameter at the distal tip of the nose cone being 0.069 inches or between 0.03 inches and 0.1 inches. Again, these dimensions are for exemplary purposes only. For example, the outer diameter or maximum outer diameter of the nose cone 28 may be larger (e.g., slightly larger as illustrated) than the outer diameter of the outer tube 4910; the nose cone 28 may have the same outer diameter as 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.

In the example illustrated in fig. 54, the entire base or proximal end/portion 5112 of the nose cone 28 is angled. Upon retrieval of the delivery catheter, the continuously angled proximal end 5112 does not grab onto the docking station 10 that has been implanted in the heart. Thus, the base portion 5112 allows for easier removal of the delivery system. Referring to fig. 55, the outer tube 4910 may include a chamfered surface (chamfer)5500 to receive and mate with the continuously angled proximal end 5112.

In one non-limiting example, the continuously angled proximal end 5112 of the nose cone 28 is slip fit into the outer tube/outer sleeve 4910 (which may optionally be beveled) 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 illustrated; 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.

The docking station 10 may be coupled 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 may be coupled with the catheter assembly with one or more latches, a latching mechanism, one or more sutures (e.g., releasably attached, tied (tie), or woven through one or more portions of the docking station), one or more interlocks, combinations of these, or other attachment mechanisms. Some of these coupling or attachment mechanisms may be configured to allow retraction of the docking station into the catheter assembly without causing the docking station to catch on the edge of the catheter assembly, for example, by constraining the proximal end of the docking station to a smaller profile or collapsed configuration to allow adjustment, removal, replacement, etc. of the docking station. Fig. 56, 57A, and 57B illustrate one non-limiting example of how the docking station 10 may be coupled to the docking station connector 4914. As illustrated in fig. 50A-50D, the docking station 10, in one exemplary embodiment, self-expands as it is pushed out of the outer tube. One way to control the expansion of the docking station 10 is to anchor at least one end of the stent, such as the proximal end 12, to the docking station connector 4914. This method allows the distal end 14 of the stent to expand first, while the proximal end does not (see fig. 50B). The proximal end 12 is then disengaged from the docking station connector 4914 as the stent is relatively advanced about the outer tube 4910 and the proximal end 12 of the docking station is allowed to expand (see fig. 50D).

One way to accomplish this 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 may be included, such as two, three, four, etc. The extension 5000 can take a wide variety of different forms. Extension 5000 may engage docking station connector 4914 within outer tube 4910. In an exemplary embodiment, the docking station connector 4914 may engage the inner surface 5600 of the extension 5000. In an exemplary embodiment, in addition to the possible engagement of the inner surface 5600 (see fig. 57A) of the extension 5000 with the docking station connector 4914, the extension 5000 and docking station connector 4914 are configured to limit the retentive engagement therebetween to two points when the distal portion of the catheter assembly and/or docking station is in a straight or substantially straight configuration, although these may be similarly configured to limit the retentive engagement to another number of points, for example, three to six points. In an exemplary embodiment, the inner surface 5600 of the extension 5000 does not contact the docking station connector 4914 when the distal portion of the catheter assembly and/or docking station is in a straight or substantially straight configuration due to the radially outward biasing force of the compressed extension. In this embodiment, the inner surface 5600 of the extension 5000 may contact the docking station connector 4914 due to bending of the catheter assembly 3600 and/or docking station. The extension 5000 can include a head 5636 having a side 5640 that extends away from the straight portion 5638 at an angle β (see fig. 57A), such as between 30 and 60 degrees. Such a head 5636 can be generally triangular, as illustrated, or the angularly extending sides 5640 can be connected together by another shape, such as circular, rectangular, pyramidal, or other shape. That is, the head 5636, in the case of non-triangular shapes, may function in the same manner as the triangular head of the example.

The delivery catheter 3600 is continuously bent and curved (curve) as it moves through the vasculature of the patient's body. The head 5636 that transitions directly from the straight portion 5638 of the extension 5000 to a T-shape, curved T-shape, rounded or spherical shape will generally have more than two points of contact with its gripper (except for possible engagement of the inner surface 5600 (see fig. 17A) of the extension 5000 with the docking station connector 4914). Referring to fig. 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 head 5636 contacting docking station connector 4914 at only two points 5702, 5704. In the example illustrated in fig. 57A, the two points are the corners formed by the T-shaped groove 5710. As shown in fig. 57B, the extension 5000 may tilt as the catheter 3600 and the docking station 10 move through the body during delivery. In an exemplary embodiment, this tilting may also result in only two point contacts between the extension 5000 and the docking station connector 4914 as exemplified in fig. 57B (except for possible engagement of the inner surface 5600 (see fig. 17A) of the extension 5000 with the docking station connector 4914). Thus, the extension 5000 may tilt during delivery, increasing the flexibility of the catheter 3600 in the area of the docking station 10, while the contact of the two points prevents binding between the extension 5000 and the connector 4914.

Referring to fig. 56, 57A, and 57B, the head 5636 fits into the T-shaped groove 5710 in the holder to hold the proximal end 12 of the docking station as the distal end self-expands within the body. Docking station connector 4914 remains in the delivery catheter until relative movement out of the catheter (i.e., by retracting outer tube/outer sleeve 4910 or by advancing connector 4914, see fig. 50D). Referring to fig. 56, outer tube/outer sleeve 4910 of catheter 3600 may be disposed closely over connector 4914 such that head 5636 is captured in groove 5710 between outer tube/outer sleeve 4910 and the body of connector 4914. This capture in the recess 5710 grips the end of the docking station 10 as the docking station expands. In this way, the delivery of the docking station 10 is controlled.

Referring back to fig. 50D, at the end of expansion of the docking station 10-when the distal end of the stent has expanded-the connector 4914 moves relatively out of the outer sleeve. The heads 5636 are then free to move radially outward and disengage from the respective recesses 5710 (see fig. 56).

In one embodiment, the length of all extensions 5000 is the same. As the connector is moved relatively out of outer tube/outer sleeve 4910, groove 5710 is simultaneously moved relatively out of outer sleeve 4910. Since the length of extension 5000 is all the same, grooves 5710 with heads 5636 will all be exposed simultaneously from delivery outer sleeve 4910. Thus, the head 5636 of the docking station will move radially outward and release all at once.

In an alternative embodiment, the docking station 10 is provided with extensions 5000 with heads 5636, but at least some of the extensions 5000 are longer than others. In that case, as connector 4914 is progressively moved relatively out of outer sleeve 4910, the shortest extension 5000 is released from its respective one or more recesses 5710 first. Then, as the connector 4914 is moved further relative out of the outer sleeve 4910, the longer extensions 5000 are released from the respective one or more recesses 5710. As described above, in one exemplary embodiment, the docking station 10 may be deployed with the catheter/catheter assembly 3600. The catheter/catheter assembly 3600 is advanced in the circulatory system to a delivery site or treatment area. Once at the delivery site, the docking station 10 is deployed by moving the outer sleeve or outer tube 4910 relative to the inner sleeve or inner tube 4912 and attached connector 4914 and docking station 10 (see fig. 50A-50D). The outer sleeve 4910 may move relative to the inner sleeve 4912 in a wide variety of different ways. Fig. 58-61 and 62-73 illustrate examples of tools or handles 5800, 6200 that may be used to move catheter 3600 in a circulatory system and relatively move outer sleeve 4910 with respect to inner sleeve 4912 of catheter 3600, e.g., to deploy/place a docking station.

In the example illustrated in fig. 58-61, handle 5800 includes a housing 5810, a drive member 5812, and a driven shaft 5814. In the illustrated example, rotation of drive member 5812 relative to housing 5810 as indicated by arrow 5816 moves driven shaft 5814 linearly as indicated by arrow 5818. Referring to figure 60, inner sleeve 4912 is fixedly connected to housing 5810 as indicated by arrow 6000 and outer sleeve 4910 is fixedly connected to driven shaft 5814 as indicated by arrow 6002. Thus, rotating the drive member 5812 in a first direction retracts the outer sleeve 4910 relative to the inner sleeve 4912 and rotating the drive member 5812 in an opposite direction advances the outer sleeve 4910 relative to the inner sleeve 4912.

In the example illustrated in fig. 58-61, housing 5810 includes an annular groove 5820. The driving part 5812 includes an annular protrusion 5822. Annular protrusion 5822 fits within the annular groove to rotatably couple drive member 5812 to housing 5810. The drive 5812 includes an engagement portion 5830 that extends from the housing to allow a user to rotate the drive 5812 relative to the housing 5810.

In the example illustrated in fig. 58-61, housing 5810 includes linear grooves 5840 or slots (see fig. 59). The driven shaft 5814 includes a linear protrusion 5842. The linear protrusion 5842 fits within the linear groove 5840 to slidably couple the driven shaft 5814 to the housing 5810.

In the example illustrated in fig. 58-61, the drive member 5812 includes internal threads 5850. The driven shaft 5814 includes an externally threaded portion 5852. The externally threaded portion 5852 cooperates with the internal threads 5850 to operatively couple the drive member 5812 to the driven shaft 5814. That is, when the driving part 5812 rotates relative to the housing 5810 as indicated by an arrow 5816, the driven shaft 5814 is prevented from rotating due to the linear protrusion 5842 fitted within the linear groove 5840. Thus, rotation of drive member 5812 within housing 5810 causes driven shaft 5814 to slide linearly 5818 along linear groove 5840 due to the mating engagement of male threaded portion 5852 with female threads 5850. Since the outer/outer tube 4910 is connected to the driven shaft 5814 and the inner/inner tube 4912 is connected to the housing 5810, the outer/outer tube 4910 is advanced and retracted relative to the inner/inner tube 4912 by rotation of the drive member 5812.

In the example illustrated in fig. 58-61, the outer/outer tube 4910 is fixedly attached in a groove 5850 in the driven shaft 5814, and an optional seal 5852 is provided between the outer/outer tube 4910 and the inner/inner tube 4912 and/or between the outer/outer tube 4910 and the driven shaft 5814. Luer 5862 is fixedly attached to housing 5810, e.g., as shown at the proximal end of housing 5810. The inner shaft/tube 4912 is fixedly attached in a groove 5860 in luer 5862. The luer 5862 is configured to receive a guidewire 5002 (see fig. 49) extending through the inner shaft/tube 4912.

In the example illustrated in fig. 62-67, the handle 6200 includes a housing 6210, a drive wheel 6212, and a driven member 6214. In the illustrated example, rotation of the drive wheel 6212 relative to the housing 6210 as indicated by arrow 6216 causes the driven member 6214 to move linearly as indicated by arrow 6218 (compare the position of the driven member 6214 in fig. 64A and 64B). Referring to figure 62, the inner sleeve/tube 4912 is fixedly attached to the housing 6210 and the outer sleeve/tube 4910 is fixedly attached to the driven member 6214. Thus, rotating the drive wheel 6212 in a first direction retracts the outer sleeve 4910 relative to the inner sleeve 4910 and rotating the drive wheel 6212 in an opposite direction advances the outer sleeve/outer tube 4910 relative to the inner sleeve/inner tube 4912. Although, in the various embodiments shown in figures 58-73, inner sleeve/inner tube 4912 is shown and described as being immovably connected relative to the handle or the proximal end of the handle and outer sleeve/outer tube 4910 is movable relative to the handle or the proximal end of the handle, in an embodiment utilizing similar concepts, inner sleeve/inner tube 4912 is movable relative to the handle or the proximal end of the handle and outer sleeve/outer tube 4910 is immovably connected relative to the handle and the proximal end of the handle, or both inner sleeve/inner tube 4912 and outer sleeve/outer tube 4910 may be configured to be movable relative to each other and relative to the handle or the proximal end of the handle.

In the example illustrated in fig. 62-67, the housing rotatably receives the axle 6822 of the drive wheel 6212 to rotatably couple the drive wheel to the housing 6210. The drive wheel 6212 includes an engagement portion 6230 that extends from the housing 6210 to allow a user to rotate the drive wheel 6212 relative to the housing 6210.

In the example illustrated in fig. 62-67, the housing 6210 includes linear projections 6240 (see fig. 66). The driven member 6214 includes a linear slot 6242 (see fig. 62, 66) into which the protrusion 6240 fits to slidably couple the driven member 6214 to the housing 6210.

In the example illustrated in fig. 62-67, the drive member 6212 includes a pinion gear 6250. The driven member 6214 includes a rack portion 6252. The pinion 6250 meshes with the rack portion 6252 to operatively couple the drive wheel 6212 to the driven member 6214. That is, as the drive wheel 6212 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 fitting within the linear recess 6242. Accordingly, rotation of the driving member 6212 relative to the housing 6210 causes the pinion gear 6250 to drive the rack portion 6252 to cause the driven member 6214 to linearly slide 6218 relative to the housing 6210. Since the outer/outer tube 4910 is connected to the driven member 6214 and the inner/inner tube 4912 is connected to the housing 5810, the outer/outer tube 4910 is advanced and retracted relative to the inner/inner tube 4912 by rotation of the drive wheel 6212.

In the example illustrated in fig. 62-67, the outer shaft/tube 4910 is fixedly attached in a support portion 6250 extending from a rack portion 6252 of the driven component 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 component 6214. The luer 5862 is fixedly attached to the housing 6210, for example, at the proximal end of the housing 6210. The inner shaft/tube 4912 is fixedly attached in a groove 5860 in luer 5862. The luer 5862 is configured to receive a guidewire 5002 (see fig. 49) extending through the inner shaft/tube 4912.

Referring to fig. 63, in an exemplary embodiment, catheter 3600 may be flushed by administering a fluid to inner tube 4912, such as to the inner tube through luer 5862. As described above, the delivery catheter 3600 includes an outer lumen formed within the outer tube/outer sleeve 4910 and an inner lumen formed within the inner tube/inner sleeve 4912, and the inner lumens and inner tube 4912 are longitudinally coaxial with the outer lumen and outer tube 4910. The annular cavity/gap/space 6348 between the inner tube 4912 and the outer tube 4910 may result from, for example, the need to provide space for a crimped stent to travel through the catheter 3600. This gap/space 6348 may be initially filled with air and then later expelled and replaced with a liquid, such as a saline solution. Irrigation in this manner can be performed with the various handle embodiments shown in fig. 58-73.

In an exemplary embodiment, a fluid, such as saline or another suitable fluid, flows from luer 5862 and through the lumen of inner tube 4912 as indicated by arrow 6360. In this embodiment, the inner tube 4912 is provided with one or more flushing holes 6354. Fluid flows through the interior of inner tube 4912, out of holes 6354 and into gap/space 6348 as indicated by arrows 6370.

As the gap/space 6348 fills with fluid, air is pushed out of the delivery catheter through the distal end of the outer tube 4910. In an exemplary embodiment, the nose cone 28 is disengaged from the distal end of the outer tube 4910 to allow air to flow from the outer tube and out of the catheter 3600. Fluid also flows through the lumen of inner tube 4912 to push air out of the lumen. In an exemplary embodiment, air is forced out of the lumen through an opening 6390 in the tip of the nose cone 28 (see fig. 49A and 49B). This flush procedure is performed prior to introducing the delivery catheter 3600 into the body. The devices and methods of this approach save space compared to, for example, providing a side hole on the outer tube 4910 for introducing irrigation fluid into the delivery catheter assembly or gap/space 6348.

Referring to fig. 68-73, in one exemplary embodiment, the handle 6200 illustrated in fig. 62-67 may be provided with a ratchet mechanism 6800. The ratchet mechanism 6800 can take a wide variety of different forms and can be used with the handle 6200 in a variety of different ways. In one exemplary embodiment, the ratchet mechanism 6800 is used during "recapture" of the docking station 10 to pull it back into the delivery catheter 3600. The force required to recapture the docking station may be significant. Thus, the ratchet mechanism 6800 may be configured such that, when the ratchet mechanism is engaged (fig. 68-71), the drive wheel 6212 may only be rotated in a direction to pull the docking station 10 back into the outer tube/outer sleeve 4910. That is, the spring force of the docking station 10 is prevented from pulling the docking station back out of the outer tube by the ratchet mechanism 6800. For example, if the operator releases the drive wheel 6212, the operator may continue to recapture the docking station 10 without sliding the docking station rearward.

Referring to fig. 68-71, one exemplary ratchet system utilizes a projection 6810 having a stop surface 6812 on one side of the projection and a ramp surface 6814 on the other side of the projection. 68-71 illustrate an engaged condition, wherein the ratchet arm 6892 is positioned to engage the projection 6810 to allow the drive wheel 6212 to rotate in one direction and prevent the drive wheel from turning in the opposite direction. For example, the ratchet arm 6892 can be configured to ride over the ramp surface 6814 to allow the drive wheel 6212 to move in the retraction direction 6850. For example, the ratchet arm 6892 can be curved to ride over the sloped ramp surface 6814. The stop surface 6812 is configured to engage the ratchet arm 6892 and prevent the drive wheel from rotating in the propulsion direction 6852. For example, the stop surface 6812 can be substantially orthogonal to the side surface 6870 of the drive wheel 6212 to prevent the ratchet arm from moving over the projection 6810.

Fig. 72 and 73 illustrate ratchet mechanism 6800, wherein ratchet arm 6892 is moved out of engagement with projection 6810. This allows the drive wheel 6212 to turn in either direction. For example, as the docking station 10 is being deployed, the ratchet mechanism 6800 can be placed in a disengaged condition to allow the drive wheel 6212 to turn in either direction.

In ratchet systems, the ratchet teeth are typically placed on the outer periphery of the wheel. By placing the teeth on the surface of the wheel, the radial diameter of the wheel can be reduced, saving space. It also allows the outer periphery of the wheel to be used as a thumb grip (grip) rather than, for example, having a second wheel for gripping in engagement with the first wheel. It also allows the wheel itself to be thinner. The wheel may be made of any material such as polycarbonate.

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

The foregoing generally describes embodiments of a self-expanding docking station. The docking stations and/or delivery devices shown and described herein may be modified within the scope of the present disclosure for delivering a balloon expandable and/or mechanically expandable docking device. That is, delivery of the balloon expandable and/or mechanically expandable docking station to the implantation site may be performed percutaneously using a modified version of the delivery device of the present disclosure. Generally, it includes providing a transcatheter assembly that may include a delivery sheath as described above and/or additional sheaths. In the case of a balloon expandable docking station, the device generally further includes a delivery catheter, a balloon catheter, and/or a guidewire. A delivery catheter for use in a balloon expandable type of delivery device may define a lumen that receives the balloon catheter. The balloon catheter, in turn, defines a lumen within which a guidewire is slidably disposed. Further, the balloon catheter includes a balloon fluidly connected to an inflation source. With the docking station mounted on the balloon, the transcatheter assembly is delivered through a percutaneous opening in the patient by a delivery device. Once the docking station is properly positioned, the balloon catheter is operated to inflate the balloon, thus transitioning the docking station to an expanded arrangement.

In view of the many possible embodiments to which the principles of the disclosed invention may be applied, it should be recognized that the illustrated embodiments are only preferred examples of the invention and should not be taken as limiting the scope of the invention. All combinations and subcombinations of the features of the foregoing exemplary embodiments are contemplated by this application. The scope of the invention is defined by the appended claims. We therefore claim as our invention all that comes within the scope and spirit of these claims.

Claims

1. An expandable docking station for an expandable valve, comprising:

a valve seat expandable to a deployed size;

one or more sealing portions coupled to the valve seat extending radially outward of the valve seat, wherein the one or more sealing portions are configured to expand outward of the valve seat and provide a seal over a range of sizes; and

wherein the length of the docking station is adjustable.

2. The expandable docking station of claim 1, wherein the docking station comprises a first half into which a second half extends.

3. The expandable docking station of any of claims 1-2, wherein the valve seat is not substantially expanded radially outward by a radially outward force of the expandable valve.

4. The expandable docking station of any one of claims 1-3, wherein the size range includes 27mm to 38 mm.

5. The expandable docking station of any of claims 1-4, wherein the docking station is configured to expand radially outward to varying degrees along its length L.

6. The expandable docking station of any one of claims 1-5, wherein the valve seat and the one or more sealing portions act as an isolator that substantially prevents radially outward forces of the expandable valve from being transferred to the one or more sealing portions.

7. The expandable docking station of any one of claims 1-6, wherein the valve seat is formed by a suture.

8. The expandable docking station of any of claims 1-7, wherein the sealing portion comprises a portion of a metal frame covered with fabric.

9. The expandable docking station of any one of claims 1-8, wherein the sealing portion comprises an open cell foam.

10. The expandable docking station of any of claims 1-9, wherein portions of the docking station are permeable to blood and portions of the docking station are impermeable to blood.

11. A system, comprising:

an expandable docking station, the expandable docking station comprising:

a valve seat expanded to a deployed size;

one or more sealing portions coupled to the valve seat configured to expand radially outward of the valve seat and provide a seal over a range of expanded sizes; and

wherein the length of the docking station is adjustable;

an expandable valve, comprising:

an expandable frame expandable to engage the valve seat of the docking station;

a valve element connected to the expandable frame.

12. The system of claim 11, wherein the docking station comprises a first half into which a second half extends.

13. The system of any one of claims 11-12, wherein the valve seat is not substantially radially outwardly expanded by a radially outward force of the expandable valve.

14. The system of any one of claims 11-13, wherein the size range comprises 27mm to 38 mm.

15. The system of any of claims 11-14, wherein the docking station is configured to expand radially outward to varying degrees along its length L.

16. The system of any one of claims 11-15, wherein the valve seat is formed by a suture.

17. The system of any of claims 11-16, wherein the sealing portion comprises a portion of a metal frame covered with fabric.

18. The system of any one of claims 11-17, wherein the sealing portion comprises an open cell foam.

19. The system of any of claims 11-18, wherein a portion of the docking station is permeable to blood and a portion of the docking station is impermeable to blood.

20. A catheter and docking station system, comprising:

sleeve barrel:

a docking station holder disposed in the sleeve, wherein the docking station holder comprises one or more holder grooves;

a docking station disposed in the sleeve, wherein the docking station comprises one or more extensions releasably attached to the docking station holder, wherein each of the one or more extensions comprises a head disposed in at least one of the one or more holder recesses;

wherein each of the one or more docking extensions contacts the docking station holder at only two points.

21. The system of claim 20, wherein the head is triangular.

22. The system of any one of claims 20-21, wherein the one or more extensions consist of two extensions.

23. The system of any of claims 20-22, wherein the one or more holder recesses in the docking station holder comprise rectangular recesses.

24. The system of any one of claims 20-23, wherein the sides of the head extend away from each other at an angle between 60 degrees and 120 degrees.

25. The system of any one of claims 20-24, wherein the sleeve engages the one or more extensions to retain the one or more heads in the retainer groove when the sleeve is positioned over the one or more extensions.

26. The system of claim 25, wherein the one or more extensions spring radially outward relative to the docking station holder when unconstrained by the sleeve to release the one or more extensions from the docking station holder.

27. The system of any one of claims 20-26, wherein the one or more extensions are tiltable in the one or more grooves.

28. A method of using a docking station, comprising:

placing a head of a docking station extension in a recess of a docking station holder, wherein the docking station extension contacts the docking station holder with only two points;

placing the docking station and the docking station holder in a sleeve, wherein the sleeve engages the docking station extension to retain the head of the docking station extension in the recess.

29. The method of claim 28, wherein the head is triangular.

30. The method of any of claims 28-29, wherein the recess in the docking station holder comprises a rectangular recess.

31. The method of any one of claims 28-30, wherein the sides of the head extend away from each other at an angle between 60 degrees and 120 degrees.

32. The method of any of claims 28-31 further comprising removing the holder and the docking station from the sleeve such that the head of the docking station extension springs radially outward relative to the docking station holder to release the docking station extension from the docking station holder.

33. The method of any one of claims 28-32, further comprising tilting the extension in the groove.