Patent ID: 12186184

DETAILED DESCRIPTION

The following description refers to the accompanying drawings, which illustrate specific embodiments of the invention. Other embodiments having different structures and operation do not depart from the scope of the present invention. Exemplary embodiments of the present disclosure are directed to devices and methods for providing a docking station/device or landing zone for a prosthetic valve (e.g., a transcatheter valve, such as a transcatheter heart valve), e.g., valve29. In some exemplary embodiments, docking stations/devices for prosthetic valves or THVs are illustrated as being used within the superior vena cava (SVC), inferior vena cava (IVC), or both the SVC and the IVC, although the docking stations/devices (e.g., docking station/device10, other docking stations/devices herein, modified versions of the docking stations, etc.) can be used in other areas of the anatomy, heart, or vasculature, such as the tricuspid valve, the pulmonary valve, the pulmonary artery, the aortic valve, the aorta, the mitral valve, or other locations. The docking stations/devices described herein can be configured to compensate for the deployed transcatheter valve or THV being smaller and/or having a different geometrical shape than the space (e.g., anatomy/heart/vasculature/etc.) in which it is to be placed. For example, the native anatomy (e.g., the IVC) can be oval, egg shaped, or another shape, while the prosthetic valve or THV can be cylindrical.

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

For the sake of uniformity, in these Figures and others in the application the docking stations are typically depicted such that the right atrium end is up, while the ventricular end or IVC end is down unless otherwise indicated.

FIGS.1A and1Bare cutaway views of the human heart H in diastolic and systolic phases, respectively. The right ventricle RV and left ventricle LV are separated from the right atrium RA and left atrium LA, respectively, by the tricuspid valve TV and mitral valve MV; i.e., the atrioventricular valves. Additionally, the aortic valve AV separates the left ventricle LV from the ascending aorta (not identified) and the pulmonary valve PV separates the right ventricle from the pulmonary artery PA. Each of these valves has flexible leaflets extending inward across the respective orifices that come together or “coapt” in the flowstream to form the one-way, fluid-occluding surfaces. The docking stations and valves of the present application are described, for illustration, primarily with respect to the inferior vena cava IVC, superior vena cava SVC, and aorta/aortic valve. A defective aortic valve, for example, can be a stenotic aortic valve and/or suffer from insufficiency and/or regurgitation. The blood vessels, such as the aorta, IVC, SVC, pulmonary artery, may be healthy or may be dilated, distorted, enlarged, have an aneurysm, or be otherwise impaired. Anatomical structures of the right atrium RA, right ventricle RV, left atrium LA, and left ventricle LV will be explained in greater detail. The devices described herein can be used in various areas whether explicitly described herein or not, e.g., in the IVC and/or SVC, in the aorta (e.g., an enlarged aorta) as treatment for a defective aortic valve, in other areas of the heart or vasculature, in grafts, etc.

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

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

The length L, diameter D, and curvature or contour may vary greatly between the superior vena cava SVC and inferior vena cava IVC of different patients. The relative orientation and location of the IVC and/or SVC can also vary between patients Further, the size or diameter D can vary significantly along the length L of an individual IVC and/or SVC. Also, the anatomy of the IVC and/or SVC is soft, flexible, and dynamic as compared to other cardiac vessels, such as the aorta. This softer, more flexible, and/or more dynamic (moving and/or shape changing) characteristic of the IVC and SVC make it more difficult for a transcatheter valve frame or a docking station that supports a transcatheter valve to anchor in the IVC and/or the SVC than in the aorta. Further, other regions or other vasculature in other areas of the body and across patients where docking stations could be used can also vary significantly in shape and size.

The left atrium LA receives oxygenated blood from the left and right pulmonary veins, which then travels through the mitral valve to the left ventricle. During the diastolic phase, or diastole, seen inFIG.1A, the oxygen rich blood that collects in the left atrium LA passes through the mitral valve MV by and into the left ventricle LV as the left ventricle LV expands. In the systolic phase, or systole, seen inFIG.1B, the left ventricle LV contracts to force the oxygen rich blood through the aortic valve AV and aorta into the body through the circulatory system. In one exemplary embodiment, the devices described by the present application are used to supplement or replace the function of a defective aortic valve. For example, the devices herein are particularly effective for treating aortic insufficiency. During diastole, the leaflets of a normally functioning aortic valve AV close to prevent the oxygen rich blood from regurgitating back into the left ventricle LV. When the aortic valve does not operate normally, blood backflows or regurgitates into the left ventricle LV. A THV implanted in the aortic valve helps prevent or inhibit blood from back-flowing into the left ventricle LV during the diastole phase. The length L, diameter, D, and curvature or contour of the aortic root may vary greatly between different patients, especially if the aorta is a dilated, distorted, or enlarged. Further, the size or diameter D may vary significantly along the length L of an individual aorta.

Referring toFIGS.2,3A,3B, and3C, in one exemplary embodiment an expandable docking station/device10includes one or more sealing portions310, a valve seat18, and one or more retaining portions314. The sealing portion(s)310provide a seal between the docking station10and an interior surface416(SeeFIG.2) of the circulatory system. The valve seat18provides a supporting surface for implanting or deploying a valve29in the docking station10after the docking station10is implanted in the circulatory system. Optionally, the docking station10and the valve29can be integrally formed, for example, in one embodiment, the valve seat18can be omitted. When integrally formed, the docking station10and the valve29can be deployed as a single device, rather than first deploying the docking station10and then deploying the valve29into the docking station. Any of the docking stations and/or valve seats18described herein can be provided or formed with an integrated valve29.

The retaining portion314helps retain the docking station10and the valve29at the implantation position or deployment site in the circulatory system. The retaining portion314can take a wide variety of different forms. In one exemplary embodiment, the retaining portion314includes friction enhancing features that reduce or eliminate migration of the docking station10. The friction enhancing features can take a wide variety of different forms. For example, the friction enhancing features can comprise barbs, spikes, texturing, adhesive, and/or a cloth or polymer cover with high friction properties on the retaining portions314. Such friction enhancing features can also be used on any of the various docking stations or retaining portions described herein.

Expandable docking station10and valve29as described in the various embodiments herein are also representative of a variety of docking stations and/or valves described herein or that might be known or developed, e.g., a variety of different types of valves could be substituted for and/or used as valve29in the various docking stations.

FIGS.2,2A, and2Billustrate a representative example of the operation of the docking stations10and valves29disclosed herein. In the example ofFIGS.2,2A, and2B, the docking station10and valve29are deployed in the inferior vena cava IVC. However, the docking station10and valve29can be deployed in any interior surface within the heart or a lumen of the body. For example, the various docking stations and valves described herein can be deployed in the superior vena cava SVC, the tricuspid valve TV, the pulmonary valve PV, pulmonary artery, the mitral valve MV, the aortic valve AV, aorta, or other vasculature/lumens in the body.

FIGS.2and2Aillustrate the valve29, docking station10and heart H, when implanted in the IVC and the heart H is in the diastolic phase. When the heart is in the diastolic phase, the valve29opens. Blood flows from the inferior vena cava IVC and the superior vena cava SVC, into the right atrium RA. The blood that flows from the inferior vena cava IVC flows through the docking station10and valve29as indicated by arrows210. Also, while in the diastolic phase, blood in the right atrium flows through the tricuspid valve TV, and into the right ventricle RV and valve as indicated by arrows212.FIG.2Aillustrates space228that represents the valve29being open when the heart is in the diastolic phase. A variety of types of valves can be used that may open and close in a variety of ways (e.g., including valves with leaflets of tissue that open then coapt to close), so the drawings are meant to be representative of a variety of valves that can operate in different ways.FIG.2Adoes not show the interface between the docking station10and the inferior vena cava to simplify the drawing. The cross-hatching inFIG.2Arepresents blood flow through the valve29. In an exemplary embodiment, blood is prevented or inhibited from flowing between the inferior vena cava IVC and the docking station10by the seal310and blood is prevented or inhibited from flowing between the docking station10and the valve by implanting or seating the valve in the seat18of the docking station10. In this example, blood only substantially flows or is only able to flow through the valve29when the valve is open (e.g., in one embodiment, only when the heart is in the diastolic phase).

FIG.2Billustrates the valve29and docking station10, when the valve29is closed (e.g., when implanted in the IVC and the heart H is in the systolic phase). When implanted in the IVC and the heart is in the systolic phase, the valve29closes. Blood is prevented from flowing from the right atrium RA into the inferior vena cava IVC by the valve29being closed. As such, the closed valve29prevents any blood that regurgitates through the through the tricuspid valve TV during the systolic phase from being forced into the inferior vena cava IVC. The solid area252inFIG.2Brepresents the valve29being closed valve is open (e.g., in one embodiment, when the heart is in the systolic phase).FIG.2Bis meant to be representative of a variety of valves, even though those valves may close in different ways.

In one exemplary embodiment, the docking station10acts as an isolator that prevents or substantially prevents radial outward forces of the valve29from being transferred to the inner surface416of the circulatory system. In one embodiment, the docking station10includes a valve seat18that resists expansion, e.g., is not expanded radially outwardly (e.g., the diameter of the valve seat does not increase) or is not substantially expanded radially outward (e.g., the diameter of the valve seat increases by less than 4 mm) by the radially outward force of the transcatheter valve or valve29. The valve seat can be configured such that expansion of a THV/valve29increases the diameter of the valve seat only to a diameter less than an outer diameter of the docking station10when the docking station is implanted. Retaining portions314and sealing portions310can be configured to impart only relatively small radially outward forces on the inner surface416of the circulatory system (as compared to the radially outward force applied to the valve seat18by the valve29). Having a valve seat18that is stiffer or less radially expansive than the outer portions of the docking station (e.g., retaining portions314and sealing portions310), as in the various docking stations described herein, provides many benefits, including allowing a THV/valve29to be implanted in vasculature or tissue of varying strengths, sizes, and shapes. The outer portions of the docking station can better conform to the anatomy (e.g., vasculature, tissue, heart, etc.) without putting too much pressure on the anatomy, while the THV/valve29can be firmly and securely implanted in the valve seat18with forces that will prevent or mitigate the risk of migration or slipping.

The docking station10can include any combination of one or more than one different types of valve seats18, retaining portions314, and/or sealing portions310. For example, the valve seat18can be a separate component that is attached to the frame350of the docking station10, while the sealing portion is integrally formed with the frame350of the docking station. Also, the valve seat18can be a separate component that is attached to the frame350of the docking station10, while the sealing portion310is a separate component that is also attached to the frame350of the docking station. Optionally, the valve seat18can be integrally formed with the frame350of the docking station10, while the sealing portion is integrally formed with the frame350of the docking station. Further, the valve seat18can be integrally formed with the frame350of the docking station10, while the sealing portion is a separate component that is attached to the frame350of the docking station10.

The sealing portion310, the valve seat18, and one or more retaining portions314of the various docking stations herein can take a variety of different forms and characteristics. InFIGS.3A-3C, an expandable frame350provides the shape of the sealing portion310, the valve seat18, and the retaining portion314. The expandable frame350can take a wide variety of different forms. The illustrated expandable frame350inFIGS.3A-3Chas an end362having an inside diameter364and an outside diameter366. An annular or cylindrical outer portion or wall368extends downward from the outside diameter366of the end362. An annular or cylindrical valve seat or wall18extends downward from the inside diameter364of the end362. In the illustrated example, the expandable frame350is an expandable lattice. The expandable lattice can be made in a variety of ways, e.g., with individual wires connected to form the lattice, braiding, cut from a sheet and then rolled or otherwise formed into the shape of the expandable frame, molded, cut from a cylindrical tube (e.g., cut from a nitinol), other ways, or a combination of these.

The frame350can be made from a highly flexible metal, metal alloy, or polymer. Examples of metals and metal alloys that can be used include, but are not limited to, nitinol and other shape memory alloys, elgiloy, and stainless steel, but other metals and highly resilient or compliant non-metal materials can be used to make the frame350. These materials can allow the frame to be compressed to a small size, and then when the compression force is released, the frame will self-expand back to its pre-compressed diameter and/or the frame can be expanded by inflation of a device positioned inside the frame. The frame350can also be made of other materials and be expandable and collapsible in different ways, e.g., mechanically-expandable, balloon-expandable, self-expandable, or a combination of these.

The sealing portions can take a wide variety of different forms. In the example ofFIGS.3A-3C, a covering/material21is attached to a portion of the frame350to form the sealing portion310. However, the sealing portion310can be formed in a wide variety of other ways. The covering/material21can be a fabric material, polymer material, or other material. The sealing portion310can take any form that prevents or inhibits the flow of blood from flowing around the outside surface of the valve29and through the docking station. In the example ofFIGS.3A,3B, and3C, the sealing portion310comprises a covering/material21(e.g., a fabric or other covering material that can be the same as or similar to other coverings/materials described herein) that extends up to the valve seat18. The covering/material21can be shaped and positioned in a variety of ways, e.g., the covering/material can be configured to partially cover the valve seat18, entirely cover the valve seat18, or not cover the valve seat18when the frame350is expanded. The covering/material21(e.g., fabric or other covering material) that forms the sealing portion310can also extend radially outward, covering the end362of the frame350, and can optionally extend (e.g., longitudinally, downward, etc.) to cover at least a portion of the annular outer portion or wall368. The sealing portion310provides a seal between the docking station10and an interior surface416(SeeFIG.2) of the circulatory system. That is, the sealing portion310and the closed valve29prevent or inhibit blood from flowing in the direction indicated by arrow377. In the example ofFIGS.3A and3B, blood is not inhibited from flowing in the direction indicated by arrow378into the area379between the valve seat18and the annular outer portion or wall368.

The valve seat can take a wide variety of different forms. The valve seat18is a portion of the frame350in the example ofFIGS.3A-3C. However, the valve seat18can be formed separately from the frame350. The valve seat18can take any form that provides a supporting surface for implanting or deploying a valve29in the docking station10after the docking station10is implanted in the circulatory system. The valve seat can optionally be reinforced with a reinforcing material (e.g., a suture, wire, band, collar, etc. that can circumscribe the valve seat or a portion of the valve seat). The valve29is schematically illustrated inFIG.3Ato indicate that the valve29can take a wide variety of different forms.FIG.3Dillustrates the more specific example where the valve29is a leaflet type THV, such as the Sapien 3 valve available from Edwards Lifesciences. In one exemplary embodiment, a valve29is integrated with or replaces the valve seat18, such that docking station10is configured as a transcatheter valve that is delivered as a single unit in the same step (as opposed to first implanting a docking stations and subsequently implanting a separate valve/THV in the docking station). Optionally, any of the docking stations described herein can be formed as a valve or THV, e.g., with valve tissue or other valve material integrated into the docking station.

The retaining portions314can take a wide variety of different forms. For example, the retaining portion(s)314can be any structure that sets the position of the docking station10in the circulatory system. For example, the retaining portion(s)314can press against or into the inside surface416or contour/extend around anatomical structures of the circulatory system to set and maintain the position of the docking station10. The retaining portion(s)314can be part of or define a portion of the body and/or sealing portion of the docking station10or the retaining portion(s)314can be a separate component that is attached to the body of the docking station. The docking station10can include a single retaining portion314or two, or more than two retaining portions. The retaining portion(s)314can include friction enhancing features as discussed above.

In the example ofFIGS.3A-3C, the retaining portion314comprises the annular outer portion or wall368of the frame350. A shape set (e.g., a programmed shape of a shape memory material) of annular outer portion or wall368can bias the annular outer portion or wall368radially outward and into contact with/against the interior surface416of the circulatory system to retain the docking station10and the valve29at the implantation position. In the illustrated embodiment, the retaining portion314is elongated to allow a relatively small force to be applied to a large area of the interior surface416, while the valve29can apply a relatively large force to the valve seat18. For example, the length of the retaining portion314can be twice, three times, four times, five times, or greater than five times the outside diameter of the transcatheter valve. Applying a small radially outward force over a larger area can be sufficient to securely hold the docking station in place, and this design/configuration can allow the docking station to conform to the unique shape/size of the anatomy and avoid/reduce the likelihood of damaging relatively weaker native tissue. Thereby the valve29can be securely held in a variety of locations and anatomies (e.g., the docking station ofFIGS.3A-Dis usable in the IVC, SVC, aorta, etc.).

In the examples ofFIGS.77and78, the retaining portion314can comprise the annular outer portion or wall368of the frame350. A shape set (e.g., a programmed shape of a shape memory material) of annular outer portion or wall368biases the annular outer portion or wall368radially outward and into contact with/against the interior surface416of the aorta to retain the docking station10and the valve29at the implantation position. In the examples ofFIGS.77and78, the shape set can also be selected to substantially match the shape of a portion of the aorta. The retaining portion314can be elongated to allow a relatively small force to be applied to a large area of the interior surface416, while the valve29can apply a relatively large force to the valve seat18, as discussed above.

FIGS.4A-4Dschematically illustrate an exemplary deployment of the docking station10and valve29in the circulatory system. Referring toFIG.4A, the docking station10is in a compressed form/configuration and is introduced to a deployment site in the circulatory system. For example, the docking station10, can be positioned at a deployment site in a SVC, IVC, aorta, or other location. Referring toFIG.4B, the docking station10is expanded in the circulatory system such that the sealing portion(s)310and the retaining portion(s)314engage the inside surface416of a portion of the circulatory system. Referring toFIG.4C, after the docking station10is deployed, the valve29is in a compressed form and is introduced into the valve seat18of the docking station10. Referring toFIG.4D, the valve29is expanded in the docking station, such that the valve29engages the valve seat18and the seat18of the docking station supports the valve. The docking station10allows the valve29to operate within the expansion diameter range for which it is designed. In the examples depicted herein, the docking station10is longer than the valve. However, in some embodiments the docking station10can be the same length or shorter than the length of the valve29. Similarly, the valve seat18can be longer, shorter, or the same length as the length of the valve29.

FIG.4Eillustrates that the inner surface416of the circulatory system, such as the inner surface of a blood vessel or anatomy of the heart can vary in cross-section size and/or shape along its length. In an exemplary embodiment, the docking station10is configured such that it can expand radially outwardly to varying degrees along its length L to conform to shape of the inner surface416. In one exemplary embodiment, the docking station10is configured such that the sealing portion(s)310and/or the retaining portion(s)314engage the inner surface416, even though the shape of the blood vessel or anatomy of the heart vary significantly along the length L of the docking station. The docking station can be made from a very resilient or compliant material to accommodate large variations in the anatomy.

FIGS.5A-5C and6illustrate an exemplary embodiment of an expandable docking station that is similar to the embodiment ofFIGS.3A and3B, except blood is inhibited from flowing in the direction indicated by arrow378into the area379between the valve seat18and the annular outer portion or wall368. Blood can be prevented or inhibited from flowing into the area379in a wide variety of different ways. In the example ofFIGS.5A-5C, a covering material500forms a closed toroid over the frame350. That is, the covering material500covers the end surface362and a span510between the end surface362and the annular valve seat or wall18. As such, the covering material500prevents entry or slows entry of blood into the area379. In the example ofFIGS.5A-5C and6, the end surface362and the valve seat or wall18are offset and the span510is a conical or inclined ring with a hole in the center. In one exemplary embodiment, an end362of the annular outer portion or wall368and the valve seat or wall18are coplanar or substantially coplanar and the end surface362is a ring or a disc with a hole in the center

FIGS.7A,7B,8A and8Billustrate additional embodiments where blood is inhibited from flowing between the valve seat18and the annular outer wall368. In the example ofFIGS.7A and7B, the expandable docking station includes an outer frame ring750and a separate inner frame ring752, instead of unitary frame350. A toroid-shaped foam piece710fills the space712between the outer frame ring750and the inner frame ring752. The toroid-shaped foam piece710is illustrated as filling an entire volume defined by the rings750,752, and having the same height as rings750and752. However, in other exemplary embodiments a height H1of the foam piece710can be less than or greater than the height H2of the rings750,752. Similarly, while the expandable frame rings are illustrated as being the same heights, the heights of each of the frame rings can be different, e.g., the outer frame ring750can have a large height to spread the retaining force across a large area of internal surface416. The inner frame ring752can have a small height to focus the radial outward force of the valve on a small area of the inner frame ring752.

In the example ofFIGS.7A and7B, the sealing portion310comprises the foam piece710and the outer ring750. The outer ring750also acts as the retaining portion314against the inner surface416. The inner ring752acts as the valve seat18.

The inner and outer expandable frames750,752can take a wide variety of different forms. The expandable frames750,752can be an expandable lattice. The expandable lattice can be made from individual wires, cut from a sheet and then rolled or otherwise formed into the shape of the expandable frame, cut from a cylinder/tube/cylindrical sheet, molded, etc. The frames750,752can be made from a highly flexible metal, metal alloy, or polymer. Examples of metals and metal alloys that can be used include, but are not limited to, nitinol and other shape memory alloys, elgiloy, and stainless steel, but other metals and highly resilient or compliant non-metal materials can be used to make the frame750,752. These materials can allow the frame to be compressed to a small size, and then when the compression force is released, the frame will self-expand back to its pre-compressed diameter and/or the frames can be expanded by inflation of a device/balloon.

An example of an open cell foam that can be used to form foam piece710(or any other foam parts mentioned in this application) of the docking station is a bio-compatible foam, such as a polyurethane foam (e.g., as may be obtained from Biomerix, Rockville, MD). The docking stations with the foam piece710can be self-expanding and/or expandable with an inflatable device to cause the docking station to engage an inner surface416having a variable shape.

FIGS.8A and8Billustrate an exemplary embodiment of a docking station10that is substantially the same as the docking station ofFIGS.7A and7B, except the inner frame ring752is omitted. In the example ofFIGS.8A and8B, the inner surface810of the foam piece710acts as the valve seat18. The inner surface810of the foam piece710can form a valve seat in a wide variety of different ways. For example, the inner surface810can be made to be substantially inelastic or unexpandable from a predetermined deployed size. For example, the inner surface can be provided with an inelastic or substantially inelastic skin, which can be made from the same polymer as the foam (or another polymer), or the inner surface810can include a band, ring, or strand. The valve seat18can be any material capable of supporting the radially outward force of the transcatheter valve29.

FIGS.9A and9Billustrate an exemplary embodiment of a docking station10that is substantially the same as the docking station ofFIGS.8A and8B, except the outer frame ring750is omitted. In the example ofFIGS.9A and9B, the outer surface910of the foam piece710acts as the sealing and retaining portions310,314.

FIG.10is a perspective view of a docking station10that includes a foam piece710. The docking station ofFIG.10can include both the inner frame ring7520and the outer frame ring750, the outer frame ring750only, the inner frame ring752only, or no frame ring.

FIGS.6-10can be separate docking stations or form a portion of another docking station, e.g., part of one of the docking stations described/shown elsewhere herein. For example, the embodiments shown inFIGS.6-10can be used as or can form an end portion (e.g., region including and around the valve seat) of any of the docking stations shown inFIGS.3A-3D,12-18,32-36,42-45, (can be used at either end or both ends), and60A-60J, etc., and can be integral or attached.

Optionally, the docking station frame350in the various embodiments herein can be made from an elastic or superelastic material or metal. One such metal is nitinol. When the frame350of the docking station10is made from a lattice of metal struts, the body can have the characteristics of a spring. Referring toFIG.11, like a spring, when the frame350of the docking station10is unconstrained and allowed to relax to its largest diameter the frame of the docking station applies little or no radially outward force. As the frame350of the docking station10is compressed, like a spring, the radially outward force applied by the docking station increases.

As is illustrated byFIG.11, in one exemplary embodiment the relationship of the radially outward force of the docking station frame350to the diameter of the docking station is non-linear, though it can also be linear. In the example ofFIG.11, the curve1150illustrates the relationship between the radially outward force exerted by the docking station10and the compressed diameter of the docking station. In the region1152, the curve1150has a low slope. In this region1152, the radially outward force is low and changes only a small amount. In one exemplary embodiment, the region1152corresponds to a diameter between 25 mm and 40 mm, such as between 27 mm and 38 mm. The radially outward force is small in the region1152, but is not zero. In the region1154, the curve1150has a higher slope. In this region1154the radially outward force increases significantly as the docking station is compressed. In one exemplary embodiment, the body of the stent is constructed to be in the low slope region1152for both a largest vessel accommodated by the docking station10and a smallest vessel. This allows the sealing and retaining portions310,314to apply only a small radially outward force to the inner surface416of the circulatory system over a wide range of implantation diameters.

The docking station frame350can take a wide variety of different forms.FIGS.12,13and14illustrate exemplary embodiments of docking station frames. InFIG.12, a portion of the valve seat18is omitted, but the frame includes legs1250for supporting a valve seat18or forming a portion of a valve seat. InFIGS.13and14two examples of valve seats18are shown connected to the legs1250. InFIG.13, the valve seat18comprises a separate valve seat component attached to the legs1250. InFIG.14, the valve seat18is integrally formed with the legs1250. In other embodiments, the valve seat18is replaced/integrated with a valve/THV29and the docking station10and valve/THV are configured and deployed as a single unit. InFIG.14, a portion of the annular outer wall368is removed to show the integrally formed valve seat18.

In one exemplary embodiment, a thickness of struts1200of the frame varies. A wide variety of different portions of the struts1200can vary and the struts can vary in different ways. Referring toFIGS.12A and12B, in one exemplary embodiment a strut1200has a first thickness T1and a second thickness T2. In the illustrated example, the struts1200of the annular wall portion314have the first thickness T1and strut portions or links1202of the struts1200that form the end362have the second thickness T2. In this example, the thickness T2is less than the thickness T1. This reduced thickness allows the end362to bend or flex more easily and connect the annular outer portion or wall368to the valve seat18. In the illustrated example, the thicknesses T1, T2are measured in the radial outward direction (i.e. measured from an inside surface of the frame350to the outside surface). In one exemplary embodiment, the width of the struts1200is also reduced with the thickness reduction or, optionally, the width of the strut portions can be reduced instead of the thickness reduction. The thickness T2can be 90% or less of the thickness T1, the thickness T2can be 80% or less of the thickness T1, thickness T2can be 70% or less of the thickness T1, thickness T2can be 60% or less of the thickness T1, thickness T2can be half or less of the thickness T1, thickness T2can be 40% or less of the thickness T1, thickness T2can be 30% or less of the thickness T1, thickness T2can be ¼ or less of the thickness T1, or the thickness T2can be 20% or less of the thickness T1.

In the illustrated example, the entirety of the strut portions or links1202of the struts1200that form the end362have the second thickness T2. However, in other embodiments, only part of the portions/links1202that form the end362have the reduced thickness. For example, the thickness of the portions/links1202can have the thickness T2at the top or apex1204of the illustrated bend1206while another part(s) can have the thickness T1. In one embodiment, a taper1210transitions the struts1200or strut portions/links1202from the thickness T1to the thickness T2. In one embodiment, the taper is more gradual (e.g., occurs over a longer distance or length) and extends into the bend of the links1206. The thickness can also increase (e.g., taper) in the area from the top or apex1204to the valve seat18or area where the valve seat will be attached.

The length of the retaining portion314inFIGS.12-13is shows as being many times both the length/height of the valve seat and diameter of the valve seat. As discussed previously, this configuration applies a relatively small radially outward force over a larger area to the interior surface of the circulatory system and is sufficient to secure the docking station in place against the interior surface. Further, this design/configuration allows the docking station to conform to the unique shape/size of the anatomy expanding more or less in many different locations to adjust to the contours (e.g., bulges, narrowed regions, contractions, etc.) of the interior surface of the circulatory system (e.g., blood vessel) and contact more of the interior surface. In one embodiment, the docking station and frame are configures such that, when implanted, all or most of the outer surface of the docking station or frame contacts the interior surface of the circulatory system (even when irregular or varied in shape). This also helps avoid/reduce the likelihood of damaging relatively weaker native tissue (e.g., by having too much localized force and/or pressure in one, two, or more particular locations). Thereby the valve29can be securely held in a variety of locations and anatomies.

For example, the frame shown inFIGS.12,13, and14is configured such that a docking station incorporating this frame can conform to an interior shape of circulatory system when expanded inside the blood vessel such that the expandable frame can expand in multiple locations (e.g., 2, 3, 4, 5, 6, 7, 8, or more) to conform to multiple bulges of the circulatory system and/or can contracts (e.g., is less expanded, has a smaller diameter, etc.) in multiple locations (e.g., 2, 3, 4, 5, 6, 7, 8, or more) to conform to multiple narrowed regions of the circulatory system. Further, whether the native anatomy is varied or more uniform, the frame is configured such that, when a docking station incorporating the frame is expanded in the circulatory system, the majority (e.g., more than 50%), more than 60%, more than 70%, more than 80%, 50-90%, or more of an outer surface of the docking station contacts an interior surface of the circulatory system and distributes the pressure and force exerted on the interior surface by the docking station over the portion or length of the outer surface of the docking station in contact with the interior surface.

Referring toFIGS.15and16, in one exemplary embodiment the strut portions or links1202that form the end362of the frame350are twisted or otherwise angled. The portions/links1202can be twisted in a wide variety of different ways and can be twisted along their full length or just a portion of their length. The twists1500aid in crimping or compressing of the frame350. In the illustrated example, a twist1500is included at or near (e.g., adjacent) the junction1510of the portion/link1202and the annular outer portion or wall368and at or near (e.g., adjacent) the junction1520of the portion/link1202and the valve seat18. However, in other embodiments a twist1500can be provided at only one of the junction1510and the junction1520. In the illustrated example, the twists1500are ninety degree twists, forming one-hundred-eighty total degrees of twist. At the junction1510the thickness T1is greater than the width W1of the portion/link1202. At the junction1520the thickness T2is greater than the width W2of the portion/link1202. Due to the two twists1500, at the apex1204, the thickness T3can be less than the width W3, even though the portion/link1202is uniform at the apex1204. That is, due to the twists1500, the widths W1, W2at the junctions1510,1520can become the thickness T3at the apex1204and the thicknesses T1, T2at the junctions1510,1520can become the width W3. The thickness T3can be 90% or less of the width W3, the thickness T3can be 80% or less of the width W3, thickness T3can be 70% or less of the width W3, thickness T3can be 60% or less of the width W3, thickness T3can be half or less of the width W3, thickness T3can be 40% or less of the width W3, thickness T3can be 30% or less of the width W3, thickness T3can be ¼ or less of the width W3, or the thickness T3can be 20% or less of the width W3. Optionally, twists1500and a strut portion/link1202could be used that have a uniform or equal thickness with other struts1200of the frame.

The twists1500make the frame350easier to crimp or compress. For example, a thinner thickness T3at the apex1204makes the portions/links1202easier to bend at the apex1204and along their length. In addition, the angles and/or twists1500facilitate offsetting/rotation1550of the valve seat18relative to the annular outer portion or wall368. This offsetting/rotation1550reduces the amount of bending and axial outward movement1560needed when compressing or crimping the frame350. As a result, a radius of curvature of the apex1204of the compressed or crimped frame is greater than would be the case if the twists1500were not included. Since the radius of curvature is increased, the stress on the apex1204is reduced when the frame is compressed or crimped.

Referring toFIGS.17-19, in one exemplary embodiment the frame350includes a valve seat18that is offset or rotated1700relative to the annular outer portion or wall368. This offset or rotation1700angles and/or twists the portions/links1202. The offset/rotation1700aids in crimping or compressing of the frame350. Any degree of offset or rotation can be implemented. For example, compared to a strut portion/link1202ofFIG.13that extends from the annular outer portion or wall368directly toward a longitudinal or center axis A that runs longitudinally through the center of the docking station (e.g., the axis parallel to the outer wall368and in the center thereof), the offset/rotation1700can, optionally, cause each of the strut portions/links to be angled 80 degrees or less, 70 degrees or less, 60 degrees or less, 50 degrees or less, 40 degrees or less, 30 degrees or less, 20 degrees or less or 10 degrees or less relative to a radial line between the longitudinal or center axis A and the junction of the strut portion to the outer wall (e.g., relative to links or strut portions shown inFIG.13, which are parallel to such a radial line).

InFIGS.17-19, at the junction1710the thickness T1is less than the width W1of the strut1200. At the junction1720the thickness T2is less than the width W2of the strut1200. At the apex1204the thickness T3is also less than the width W3. In one exemplary embodiment, the widths W1, W2, W3are all the same. In one exemplary embodiment, the thicknesses T1, T2, T3are all the same. The thickness T3can be 90% or less of the width W3, the thickness T3can be 80% or less of the width W3, thickness T3can be 70% or less of the width W3, thickness T3can be 60% or less of the width W3, thickness T3can be half or less of the width W3, thickness T3can be 40% or less of the width W3, thickness T3can be 30% or less of the width W3, thickness T3can be ¼ or less of the width W3, or the thickness T3can be 20% or less of the width W3.

The offset/rotation1700makes the frame350easier to crimp or compress. For example, the offset/rotation1700reduces the amount of bending and axial outward movement1760needed when compressing or crimping the frame350. As a result, a radius of curvature of the apex1204of the compressed or crimped frame is greater than would be the case if the offset/rotation1700were not included. Since the radius of curvature is increased, the stress on the apex1204is reduced when the frame is compressed or crimped.

Referring toFIGS.20A-20C, in some exemplary embodiments the apex1204of the strut portion or link1202(SeeFIG.12) is shaped to make the frame350easier to compress or crimp. The apex1204can have a wide variety of different shapes. In the example ofFIG.20A, the apex includes a sharp bend2000. Leg portions2010form an acute angle (3, such as less than 60 degrees, less than 45 degrees, or less than 30 degrees. In the example ofFIG.20B, the apex1204includes an upwardly extending rounded end or tip2020that transitions to two leg portions2010at two bends2022. The rounded end or tip2020is substantially circular. For example, the rounded end or tip can be formed by a 180 degree to 300 degree (or any sub-range) arc. Leg portions2010form an acute angle θ, such as less than 60 degrees, less than 45 degrees, less than 30 degrees, less than 20 degrees, or less than 10 degrees. In the example ofFIG.20C, the apex1204includes a downwardly extending rounded end2030, two upwardly extending rounded portions2032, and two leg portions2010. The downwardly extending end2030is substantially circular. For example, the end2030can be formed by a 180 degree to 300 degree (or any sub-range) arc. The upwardly extending rounded portions2032are also substantially circular. For example, the upwardly extending rounded portions can be formed by a 180 degree to 300 degree (or any sub-range) arc. Leg portions2010form an acute angle α, such as less than 60 degrees, less than 45 degrees, less than 30 degrees, less than 20 degrees, or less than 10 degrees.

FIGS.21A-21Hillustrate crimping of a docking station frame350, such as the docking station frame illustrated byFIGS.17-19for installation into a delivery catheter (See for example delivery catheter2200inFIG.22A). Depending on the implantation site, the catheter can be flexible or rigid. A rigid or substantially rigid catheter can be used to access the inferior vena cava IVC or the superior vena cava SVC. A percutaneous path to the inferior vena cava IVC that is relatively straight can be used. In the example, a crimping apparatus2100includes a housing2101and wedge shaped drive members2102. InFIG.21A, the docking station frame350is in a fully expanded or substantially fully expanded condition inside the wedge shaped driving members2102. In this position, both annular outer portion or wall368and the valve seat18are fully expanded. The strut portions/links1202are shown angled in a generally clockwise direction2110as they extend from the valve seat18to the annular outer portion or wall368. Optionally, the portions/links1202can be angled in a generally counter-clockwise direction (i.e., opposite clockwise direction2110) as they extend from the valve seat18to the annular outer portion or wall368(crimping would be similar but opposite to that shown inFIGS.21A-21H).

InFIG.21B, the wedge shaped driving members2102begin to move the annular outer portion368or wall radially inward. As the annular outer portion368moves radially inward, the junctions1710(SeeFIG.17) moves radially inward and the strut portions/links1202force a top end2120of the valve seat18radially inward, while a bottom/proximal end2122of the valve seat remains substantially expanded.

InFIG.21C, the wedge shaped driving members2102continue to move the annular outer portion368or wall radially inward. As the annular outer portion368moves radially inward, the junction1710(SeeFIG.17) continues to move radially inward. The strut portions/links1202continue to force the top end2120of the valve seat18radially inward, while a bottom end2122of the valve seat remains substantially expanded. As can be seen by comparingFIGS.21A-21C, the orientation of the portions/links1202has changed such that the angle in the clockwise direction2110has been diminished, eliminated, or the portions/links1202extend in the counterclockwise direction. As frame350is compressed or crimped, the radii of curvature of the apexes1204becomes smaller.

InFIG.21D, the wedge shaped driving members2102continue to move the annular outer portion368or wall radially inward. As the annular outer portion368moves radially inward, the junction1710(SeeFIG.17) continues to move radially inward. The portions/links1202force the top end2120of the valve seat18substantially closed, while a bottom end2122of the valve seat remains open. InFIG.21D, the bottom end2122of the valve seat is in contact with the annular outer portion368. The orientation of the strut portions/links1202has now clearly changed from the clockwise direction2110to the counterclockwise direction2130as they extend from the valve seat18to the annular outer portion or wall368. The radii of curvature of the apexes1204continues to become smaller. However, the angled orientation of the portion/links1202helps keep the distance between the junctions1710,1720larger to increase the radii of curvature of the apexes1204relative to non-angled portions2102that are crimped.

InFIG.21E, the wedge shaped driving members2102drive the annular outer portion368and the bottom end2122of the valve seat18radially inward. The orientation of the portions/links1202is in the counterclockwise direction2130. The radii of curvature of the apexes1204continue to become smaller.

InFIG.21F, the wedge shaped driving members2102continue to drive the annular outer portion368and the bottom end2122of the valve seat18radially inward. The orientation of the portions/links1202is in the counterclockwise direction2130. The radii of curvature of the apexes1204continue to become smaller.

InFIG.21G, the wedge shaped driving members2102continue to drive the annular outer portion368and the bottom end2122of the valve seat18radially inward. The orientation of the portions/links1202is in the counterclockwise direction2130. The radii of curvature of the apexes1204continue to become smaller.

The wedge shaped driving members2102continue to drive the annular outer portion368and the bottom end2122of the valve seat18radially inward. The radii of curvature of the apexes1204continue to become smaller. The frame350is in the fully compressed or crimped state inFIG.21H. The compressed or crimped frame350can be loaded into a catheter or a sleeve/sheath for deployment into a patient.

Referring toFIGS.22A-22C,23A-23C, and24A-24C, in some exemplary embodiments the docking station10can be configured to curl back on itself as it is deployed from a catheter2200. The docking stations10illustrated byFIGS.22A-22C and23A-23Ccan be deployed in any of the interior surfaces416or implantation locations mentioned herein. The docking station10illustrated byFIGS.24A-24Cis configured for deployment in a native valve.FIGS.22A-22C,23A-23C, and24A-24Cschematically illustrate a cross-section of a docking station10being deployed from the catheter2200. The docking station10can be made from any combination of the materials disclosed herein. For example, the docking station10can be made from a shape memory alloy frame, foam, fabric coverings, etc. The illustrated docking station10defines a valve seat18, a sealing portion310, and a retaining portion314. Embodiments shown only in cross-section in this application can be assumed to have an annular or cylindrical shape.

Referring toFIG.22A, during deployment, the docking station10first extends radially outward2220from the deployment catheter2200. Referring toFIG.22B, the docking station10then extends or curls back2222toward the deployment catheter. Referring toFIG.22C, the docking station10then extends back up2224to overlap the last portion2226of the docking station to be deployed from the catheter2200.

FIGS.23A-23Cillustrate another exemplary embodiment of a docking station10that is configured to curl back on itself as it is deployed from a catheter2200. The docking station10illustrated byFIGS.23A-23Ccan be deployed in any of the interior surfaces416mentioned herein. Referring toFIG.23A, during deployment, the docking station10first extends radially outward2220from the deployment catheter2200. Referring toFIG.23B, the docking station10then extends or curls back2222toward the deployment catheter. Referring toFIG.23C, the docking station10then extends back up2224to overlap a valve seat18of the docking station and a last portion2228of the docking station to be deployed extends radially outward2230below the curled toroidal portion2230.

FIGS.24A-24Cillustrate another exemplary embodiment of a docking station10that is configured to curl back on itself as it is deployed from a catheter2200. In the example ofFIGS.24A-24C, the docking station10is configured to curl back on itself and capture one or more leaflets2400of a native valve. For example, the docking station10can be configured to capture the leaflets of a mitral valve MV, aortic valve AV, tricuspid valve TV, or the pulmonary valve PV. Referring toFIG.24A, from inside the leaflets2400of the native valve, the docking station10deploys and extends radially outward2420from the deployment catheter2200outward of the leaflets2400. Referring toFIG.24B, the docking station10then extends or curls back2422toward and behind the leaflets2400. Referring toFIG.24C, the docking station10then extends back2424and the leaflets are sandwiched or clamped2426between the valve seat18and the portion2428of the docking station. The clamping secures the docking station10to the valve leaflets and thereby the native valve.

FIG.25illustrates an example of a strut configuration that can be employed to make or be incorporated in the curling docking station10ofFIGS.22A-22C and24A-24C. InFIG.25, the valve seat18is formed by inner struts2500. The inner struts2500extend from an end2502to a junction2504and form generally diamond shaped openings2506. Top and outer struts2510extend from the junction2504to a second end2512. The top and outer struts2510form continuous openings2516. Optionally, the end2512can extend back up2224to overlap the end2502.

FIGS.26-28illustrate an example of a strut configuration that can be employed to make or be incorporated in the curling docking station10ofFIGS.23A-23C. InFIG.25, the valve seat18is formed by inner struts2600. The inner struts2600are elongated and extend (e.g., longitudinally and radially outward) to form legs2601that extend to an end2602. The inner struts also extend upward to a junction2604and form openings2606. Top and outer struts2610extend from the junction2604to a second end2612. The top and outer struts2610form continuous openings2616. In one embodiment, end2612extends back up2224and overlaps the legs2601.

FIG.29illustrates an exemplary embodiment of a docking station10. The frame350or body can take a wide variety of different forms andFIG.29illustrates just one of the many possible configurations. In the example ofFIG.29, the retaining portion314forms a relatively wider inflow portion2912. A relatively narrower portion2916forms the seat18. A tapered portion2918joins the wider portion2912and the seat18.

In the example ofFIG.29, the frame350comprises a plurality of metal struts1200that form cells2904. In the example ofFIG.29, cells of the retaining portion314are uncovered. A covering/material21(e.g., an impermeable material, a semi-permeable material, a material like those discussed above, etc.), such as a cloth or fabric (FIG.29) or a protective foam (FIG.30) is provided over the narrow portion2916, the tapered portion2918, and the round or outer segment3216to form the sealing portion310of the docking station10. The valve29expands in the narrow portion2916, which forms the valve seat18.

The docking station can be made from a very resilient or compliant material to accommodate large variations in the anatomy. For example, the docking station can be made from a highly flexible metal, metal alloy, polymer, or an open cell foam. An example of a highly resilient metal is nitinol, but other metals and highly resilient or compliant non-metal materials can be used. The docking station10can be self-expandable, manually expandable (e.g., expandable via balloon), mechanically expandable, or a combination of these. A self-expandable docking station10can be made of a shape memory material such as, for example, nitinol.

Referring toFIG.29, in one exemplary embodiment, a band20extends about the waist or narrow portion2916, or is integral to the waist to form an unexpandable or substantially unexpandable valve seat18. The band20stiffens the waist and, once the docking station is deployed and expanded, makes the waist/valve seat relatively unexpandable in its deployed configuration. Optionally the band20can extend over some or all of the narrow portion2916. In the example ofFIG.29, the valve29is secured by expansion of its collapsible frame into the valve seat18, of the docking station10. The unexpandable or substantially unexpandable valve seat18prevents the radially outward force of the valve29from being transferred to the inside surface416of the circulatory system. However in one exemplary embodiment, the waist/valve seat of the deployed docking station can optionally expand slightly in an elastic fashion when the valve29is deployed against it. This optional elastic expansion of the waist18can put pressure on the valve29to help hold the valve29in place within the docking station.

The band20can take a wide variety of different forms and can be made from a wide variety of different materials. For example, the band20can be made of PET, PTFE, ePTFE, one or more sutures, fabric, metal, polymer, a biocompatible tape, or other relatively unexpandable materials known in the art that are sufficient to maintain the shape of the valve seat18and hold the valve29in place. The band can extend about the exterior of the stent, or can be an integral part of it, such as when fabric or another material is interwoven into or through cells of the stent. The band20can be narrow, such as the suture band inFIG.29, or can be wider. The band can be a variety of widths, lengths, and thicknesses. In one non-limiting example, the valve seat18is between 15-35 mm wide, 18-31 mm wide, 20-29 mm wide, etc., although the diameter of the valve seat should be within the operating range of the particular valve29that will be secured within the valve seat18, and can be different than the foregoing example. The valve29, when docked within the docking station, can optionally expand around either side of the valve seat slightly. This aspect, sometimes referred to as a “dogbone” (e.g., because of the shape it forms around the valve seat or band), can also help hold the valve in place.

FIG.31illustrates the docking station10ofFIG.29implanted in the circulatory system, such as in the inferior vena cava IVC. In the example ofFIG.31, the narrow portion2916and/or the tapered portion2918extend into the right atrium RA and the retaining portion314(hidden inFIG.31) is held in place in the inferior vena cava IVC. The reduced size of the narrow portion2916can prevent the docking station10from contacting an interior surface of the circulatory system or native tissue (e.g., of the right atrium RA). The covering21illustrated byFIG.30can be used to cushion any contact between the narrow portion2916and the circulator system or native tissue (e.g., right atrium) that might occur. The sealing portion310provides a seal between the docking station10and an interior surface416of the circulatory system, such as at the junction between the inferior vena cava IVC and the right atrium.

In the example ofFIG.31, the sealing portion310is formed by providing the covering/material21over the frame350or a portion thereof. In particular, the sealing portion310can comprise the narrow portion2916, the tapered portion2918and/or the retaining portion314. In an exemplary embodiment, the covering/material21(e.g., an impermeable material, semi-permeable material, cloth, polymer, foam, wax, etc.) covers the narrow portion2916, the tapered portion2918, and optionally a portion of the retaining portion314. In one embodiment, the covering/material can be configured to encourage or enhance tissue ingrowth (e.g., covering/material21can have a large surface area and/or be hydrophilic to enhance tissue ingrowth). This provides a seal and makes the docking station impermeable or substantially impermeable from the sealing portion310to the seal between the valve29and the docking station10at the valve seat18. As such, blood flowing in the inflow direction12toward the outflow direction14is directed to the valve seat18and valve29, once installed/deployed in the valve seat.

As one non-limiting example, when the docking station10is placed in the inferior vena cava, which is a large vessel, the significant volume of blood flowing through the vein is funneled into the valve29by the covering21. The covering21can be fluid impermeable or become fluid impermeable (e.g., via tissue ingrowth) so that blood cannot pass through. A variety of other covering materials (including any materials described elsewhere herein), can be used such as, for example, foam (FIG.30) or a fabric that is treated with a coating that is impermeable to blood, polyester, or a processed biological material, such as pericardium. More of the docking station frame350can be provided with the material21, forming a relatively large impermeable portion.

FIG.32illustrates an exemplary embodiment of a docking station10. The docking station illustrated byFIG.32is similar to the docking station illustrated byFIG.29, except an outer segment3216extends from the narrow portion2916. The outer segment3216is shaped to be atraumatic to the interior surface416or native anatomy. For example, the outer segment3216can be round or toroidal. The round or outer segment3216can take a wide variety of different forms. For example, the round or outer segment3216can comprise a plurality of metal struts that form cells and form part of the frame350or be attached to the frame350. The round or outer segment3216can be made of a foam material.FIG.32illustrates one of many possible configurations.

In the example ofFIG.32, the retaining portion314forms a relatively wider inflow portion2912. A relatively narrower portion2916forms the seat18. A tapered portion2918joins the wider portion2912and the seat18. The round or outer segment3216extends radially outward from the relatively narrower portion2916.

In the example ofFIG.32, the frame350comprises a plurality of metal struts1200that form cells2904. In the example ofFIG.32, cells of the retaining portion314are uncovered. A covering/material21(e.g., an impermeable material, semi-permeable material, material like those discussed above, etc.), such as a cloth or fabric or a protective foam can be provided over the narrow portion2916, the tapered portion2918, and the round or outer segment3216. The covering/material21that extends to the frame350forms the sealing portion310of the docking station10. The valve29expands in the narrow portion2916that forms the valve seat18.

The docking station can be made from a very resilient or compliant material to accommodate large variations in the anatomy. For example, the docking station can be made from a highly flexible metal, metal alloy, polymer, or an open cell foam. An example of a highly resilient metal is nitinol, but other metals and highly resilient or compliant non-metal materials can be used. The docking station10can be self-expandable, manually expandable (e.g., expandable via balloon), mechanically expandable, or a combination of these. A self-expandable docking station10can be made of a shape memory material such as, for example, nitinol.

Referring toFIG.32, in one exemplary embodiment a band20extends about the waist or narrow portion2916, or is integral to the waist to form an unexpandable or substantially unexpandable valve seat18. The band20can also extend over other portions of the docking station as well. The band20stiffens the waist and, once the docking station is deployed and expanded, makes the waist/valve seat relatively unexpandable in its deployed configuration. In the example ofFIG.32, the valve29is secured by expansion of its collapsible frame into the valve seat18, of the docking station10. The unexpandable or substantially unexpandable valve seat18prevents the radially outward force of the valve29from being transferred to the inside surface416of the circulatory system. However in one exemplary embodiment, the waist/valve seat of the deployed docking station can optionally expand slightly in an elastic fashion when the valve29is deployed against it. This optional elastic expansion of the waist18can put pressure on the valve29to help hold the valve29in place within the docking station.

The band20can take a wide variety of different forms and can be made from a wide variety of different materials. The band20can be made of PET, one or more sutures, fabric, metal, polymer, a biocompatible tape, or other relatively unexpandable materials known in the art that are sufficient to maintain the shape of the valve seat18and hold the valve29in place. The band can extend about the exterior of the stent, or can be an integral part of it, such as when fabric or another material is interwoven into or through cells of the stent. The band20can be narrow, such as the suture band inFIG.32, or can be wider. The band can be a variety of widths, lengths, and thicknesses. In one non-limiting example, the valve seat18is between 27-28 mm wide, although the diameter of the valve seat should be within the operating range of the particular valve29that will be secured within the valve seat18, and can be different than the foregoing example. The valve29, when docked within the docking station, can optionally expand around either side of the valve seat slightly, e.g., in an hourglass-like shape.

FIG.33illustrates the docking station10ofFIG.32implanted in the circulatory system, such as in the inferior vena cava IVC. InFIG.33, outer segment3216, the narrow portion2916and/or the tapered portion2918extend into the right atrium RA and the retaining portion314is held in place in the inferior vena cava IVC. Any contact between the interior surface of the right atrium RA and the docking station10is with the outer segment3216. The shape and atraumatic configuration of the outer segment3216protects the interior surface of the right atrium RA.

The sealing portion310provides a seal between the docking station10and an interior surface416of the circulatory system, such as at the junction between the inferior vena cava IVC and the right atrium. In the example ofFIG.33, the sealing portion310is formed by providing the covering/material21(which can be the same as or similar to other coverings/materials described elsewhere herein) over the frame350or a portion thereof. In particular, the sealing portion310can comprise the narrow portion2916, the outer segment3216, the tapered portion2918and/or a covered portion of the retaining portion314. In an exemplary embodiment, the covering/material21covers the outer segment3216, the narrow portion2916, the tapered portion2918, and optionally a portion of the retaining portion314. In one embodiment, the covering/material can be configured to encourage or enhance tissue ingrowth (e.g., covering/material21can have a large surface area and/or be hydrophilic to enhance tissue ingrowth). This provides a seal and makes the docking station impermeable or substantially impermeable from the sealing portion310to the seal between the valve29and the docking station10at the valve seat18. As such, blood flowing in the inflow direction12toward the outflow direction14is directed to the valve seat18(and valve29once installed in the valve seat).

As one example, when the docking station10is placed in the inferior vena cava IVC, which is a large vessel, the significant volume of blood flowing through the vein is funneled into the valve29by the covering21. The covering21can be fluid impermeable or become fluid impermeable (e.g., via tissue ingrowth) so that blood cannot pass through. A variety of biocompatible covering materials can be used such as any materials described elsewhere herein, including foam or a fabric that is treated with a coating that is impermeable to blood, polyester, or a processed biological material, such as pericardium. More of the docking station frame350can be provided with the covering/material21, forming a relatively large impermeable portion.

FIGS.34and35illustrate an exemplary embodiment where the outer segment3216of the docking station10illustrated byFIG.32is formed as a portion of the frame350. In the example ofFIGS.34and35, the valve seat18is formed by inner struts3400. The retaining portion314is formed by lower struts3410. The lower struts3410extend longitudinally and radially outward from the inner struts3400. The lower struts3410terminate at a lower end3412of the docking station10. The outer segment3216is formed by top and outer struts3520that extend radially outward3450, and then downward3452and inward3454.

InFIG.35, the entire frame350is comprises a plurality of metal struts1200that form cells2904. InFIG.32, cells of the retaining portion314are uncovered. A covering/material21(which can be the same as or similar to coverings/materials21discussed previously), such as a cloth or fabric or a protective foam can be provided at the valve seat18(i.e. inside or outside the struts1200), the round or outer segment3216and part of the retaining portion314. For example, referring toFIG.35all of the portion3550above the line3530can be covered and the portion3552below the line3530can be uncovered. The line3530can be adjusted to ensure that the material21extends to the area of contact with the inside surface416(e.g., to an area expected to be in contact with the inside surface416at the junction between the IVC and the right atrium).

The docking station illustrated byFIGS.34and35can be made from a very resilient or compliant material to accommodate large variations in the anatomy. For example, the docking station10can be made from a highly flexible metal, metal alloy, polymer, or an open cell foam. An example of a highly resilient metal is nitinol, but other metals and highly resilient or compliant non-metal materials can be used. The docking station10can be self-expandable, manually expandable (e.g., expandable via balloon), mechanically expandable, or a combination of these. A self-expandable docking station10can be made of a shape memory material such as nitinol.

FIG.36illustrates an exemplary embodiment of an expandable docking station10with a retaining portion314that is disposed in the inferior vena cava IVC and a valve seat18that is disposed in the right atrium RA. The expandable docking station10includes one or more sealing portions310, a valve seat18, and one or more retaining portions314. InFIG.36, the docking station10is configured to provide a seal3610at the atrium-vein junction3612. The seal3610at the atrium-vein junction3612can be provided in a variety of different ways. InFIG.36, the frame350transitions3616radially outward from the retaining portion314toward the end3617of the docking station10to form an enlarged portion or skirt3618. The enlarged portion or skirt3618is flexible such that the portion of the docking station that makes contact with a surface of the atrium is soft. The enlarged portion or skirt can also be covered with a foam or other material to further soften the potential areas of contact between the atrium and the docking station10.

A sealing portion310is configured to prevent or inhibit blood flow where the atrium-vein junction3612meets the enlarged portion or skirt3618when implanted. An additional sealing portion310′ is provided to prevent or inhibit blood from flowing between the valve29and docking station. In the example ofFIG.36, the additional sealing element310′ is disposed on the portion of the frame350that forms the valve seat18and extends to the sealing element310. As such, the two sealing elements310,310′ prevent or inhibit blood from flowing around the outside of the transcatheter valve29. In another exemplary embodiment, the sealing element310can cover the entire enlarged portion3618or skirt and extend into the area of the valve seat18to eliminate the need for the second sealing element310′.

The sealing portions can take a wide variety of different forms. In the example ofFIG.36, a fabric, polymer, or other covering is attached to a portion of the frame350to form the sealing portion310. However, the sealing portion310can be formed in a wide variety of other ways. The sealing portion310can take any form that prevents or inhibits the blood from flowing around the outside surface of the valve29through the docking station frame.

The retaining portions314of theFIG.36embodiment can take a wide variety of different forms. For example, the retaining portion(s)314can be any structure that sets the position of the docking station10in the circulatory system and can be the same as or similar to retaining portion(s)314discussed elsewhere in this disclosure. For example, the retaining portion(s)314can press against or into the inside surface416or extend around an anatomical structure of the circulatory system to set the position of the docking station10. The retaining portion(s)314can be part of or define a portion of the body and/or sealing portion of the docking station10or the retaining portion(s)314can be a separate component that is attached to the body of the docking station. The docking station10can include a single retaining portion314, two of these, or more than two.

InFIG.36, the retaining portion314comprises the annular outer portion or wall368of the frame350. A shape set of annular outer portion or wall368biases the annular outer portion or wall368radially outward and into contact with the interior surface416of the circulatory system to retain the docking station10and the valve29at the implantation position. The retaining portion314can be elongated to allow a small force to be applied to a large area of the interior surface416. For example, the length of the retaining portion314can be twice, three times, four times, five times, or greater than five times the outside diameter of the transcatheter valve.

Referring toFIGS.37-41, in one exemplary embodiment the frames350used in the docking stations10include springs or spring/flexible segments3700to allow the frames350to bend. The spring/flexible segments3700allow the stent segments to anchor on the walls of the blood vessel while enabling the docking station to curve if needed. In the example ofFIG.37, frame or stent segments3702are attached to each other by multiple springs or spring/flexible segments3700. Any of the frames shown and described herein can optionally have any combination of spring/flexible segments3700and frame or stent segments3702. The spring/flexible segments3700can take a wide variety of different forms. Examples of spring/flexible segments3700include, without limit, spring wires, springs constructed by selective removal of material (seeFIG.40) compression springs, torsion springs, and/or tension springs.

InFIG.38, the spring/flexible segments3700allow the frame350to more easily bend3800. The frame350can bend in a wide variety of different ways. In the example ofFIG.38, springs on one side3802stretch and springs on another side3804compress to bend3800in the indicated direction. Since multiple spring/flexible segments3700are provided in the frame350, the frame can easily bend in different directions along the length of the frame350.

FIG.39illustrates that the frame or stent segments3702are expandable3900and compressible3902. By having separate frame or stent segments3702connected by spring/flexible segments3700, the frame can more easily conform to blood vessels that have varying sizes. The combination of the frame or stent segments3702and spring segments allows the frame to conform to blood vessels that vary in cross-sectional size of the vessel, cross-sectional shape of the vessel, and the flow shape or path of the vessel.

FIG.40illustrates an exemplary embodiment where the frame or stent segments3702are integrally formed with the spring/flexible segments3700. For example, the frame or stent segments3702and the spring/flexible segments3700can be cut from a single piece of material, such as a shape memory alloy, such as nitinol. In the illustrated example, the stent segment3702comprises a matrix of interconnected struts1200that are joined to form cells4000with openings4002. However, the stent segments3702can be formed by a wide variety of different cutting patterns. The illustrated spring segments3700are formed by cutting a strap/strut4010with notches4012. But the spring/flexible segments3700can be formed with many different cutting patterns.

FIG.41illustrates an exemplary embodiment of a docking station10that includes two frame or stent segments3702connected by spring/flexible segments3700. In the example ofFIG.41, the docking station10is deployed in a blood vessel4100that is curved and has a varying cross-sectional size. A first frame or stent segment4110expands4112to a first size to conform to the size of the vessel4100at the location where the first frame or stent segment is deployed. A second frame or stent segment4120expands4122to a second, larger size to conform to the size of the vessel4100at the location where the second frame or stent segment is deployed. The vessel4100is curved from the location of the first stent or frame segment4110to the location of the second stent or frame segment4120. The spring/flexible segments3700allow the frame350to bend4130and conform to the curvature of the vessel4100.

FIGS.42-45illustrate exemplary embodiments where two docking stations10are connected together by a connecting portion4250to form a dual docking station4200. In the examples ofFIGS.42-45, the dual docking station4200is configured such that a first docking station4210can be deployed in the inferior vena cava IVC and a second docking station4212can be deployed in the superior vena cava SVC. The docking stations4210and4212can be connected together in a wide variety of different ways.

The docking stations4210,4212can take a wide variety of different forms. For example, the docking stations4210,4212can be any of the docking stations10disclosed herein. In the examples ofFIGS.42-45, one of the docking stations10illustrated byFIGS.12-19and20A-20Ccan be incorporated. The dockings stations4210,4212can be the same or the docking stations4210,4212can be a different size and/or type.

In one exemplary embodiment, one of the ends is not provided with a docking station. For example, a docking station4210can be positioned in the inferior vena cava IVC and the connecting portion4250and/or and an expandable frame4110(SeeFIG.41) extends into the superior vena cava SVC to stabilize the docking station4210, without acting as a docking station. Similarly, a docking station4212can be positioned in the superior vena cava SVC and the connecting portion4250and/or and an expandable frame4110(SeeFIG.41) extends into the inferior vena cava IVC to stabilize the docking station4212, without acting as a docking station.

The connecting portion4250can take a wide variety of different forms. In one exemplary embodiment, the connecting portion4250is constructed to allow blood to freely flow through the connecting portion. For example, the connecting portion4250can be an open cell frame4260as illustrated byFIG.42. The connecting portion4250can comprise spring portions3700as illustrated byFIG.43. The connecting portion4250can comprise wires4262as illustrated byFIG.44. In one embodiment, the connecting portion4250comprises an open cell frame4260, spring portions3700, and/or wires4262. Referring toFIG.45, in one embodiment the connecting portion4250is configured to bend as it extends from the superior vena cava SVC to the inferior vena cava IVC. In the example ofFIG.45, the connecting portion4250is configured to rest against an interior wall450of the right atrium RA. The connecting portion4250can be integrally formed with the docking stations4210,4212or the connecting portion can be made separately from one or both of the docking stations4210,4212and attached to the docking station(s).

In one embodiment, a docking station10can include sealing portions310and/or retaining portions314or combined sealing and retaining portions that are radially expandable. The sealing portions310and/or retaining portions314can be configured to expand in a wide variety of different ways. In the example ofFIGS.46and47, combined radially expandable sealing and retaining portions4610comprise a material4612, such as a fabric, cloth, foam, etc., and a line or chord4614. InFIG.47, the line or chord4614is attached to the material4612such that pulling on the line or cord4614causes the material4612to linearly retract, bunch or accordion, and thereby expand radially outward as shown. The lines or cords4614are shown taut inFIG.47to represent pulling the lines or cords (e.g., pulling down on the lower line/cord4614in the IVC and pulling up on the upper line/cord4614in the SVC, but other pulling directions/combinations are also possible) to axially contract and radially expand the material4612. For example, a first end4620of the material4612can be attached to the frame350. The line or cord4614can be attached to a second end4630. The line or chord4614can be repeatedly threaded back and forth through the material4612as it extends from the first end4620to the second end4630. As such, the material is cinched up, with the length L retracted and radial thickness T expanded.

Sealing portions310and/or retaining portions314or combined sealing and retaining portions that are radially expandable can be implemented on any docking station10disclosed herein. In the example ofFIGS.46and47, the combined radially expandable sealing and retaining portions4610are provided on a stent or frame4660to form a docking station. The radially expandable portions extend around the circumference of the stent or frame4660. The stent or frame4660can take a wide variety of different forms. For example, the stent or frame can be any conventional stent or frame or any of the frames350disclosed herein. InFIG.46, the stent or frame4660is configured to extend from the superior vena cava SVC to the inferior vena cava IVC. However, in some embodiments, the stent or frame4660can be configured to engage and seal with only one inner surface area. The stent or frame4660can be configured to engage and seal with one or more interior surface areas of the heart H. For example, a stent or frame4660with one or more radially expandable portions4610can be configured to be deployed and act as a valve seat18in the inferior vena cava IVC, the superior vena cava SVC, the aorta, the pulmonary artery, the aortic valve AV, the mitral valve MV, the pulmonary valve PV, or the tricuspid valve TV.

The stent or frame4660can take a wide variety of different forms. In the example ofFIGS.46and47, the stent or frame4660is disposed in the right atrium RA. In one embodiment, the stent or frame4660or the portion of the stent or frame4660in the right atrium has and open configuration to allow blood in the atrium to easily flow through the stent or frame4660. For example, the stent or frame4660can take any of the forms illustrated byFIGS.42-44.

The docking station profile illustrated byFIG.48is taken from U.S. patent application Ser. No. 15/422,354, titled “Docking Station for a Transcatheter Heart Valve,” filed on Feb. 1, 2017 and published as US 2017/0231756, which claims priority to provisional application No. 62/292,142, filed on Feb. 5, 2016. These application are incorporated herein by reference in their entireties. Any concepts, aspects, features or other materials disclosed by these applications can be used in combination with any of the embodiments disclosed in this application, e.g., docking station10illustrated byFIG.48can be configured to be deployed in the aorta, IVC, and/or SVC.

FIG.49illustrates an exemplary embodiment of a docking station10that is similar to the docking station illustrated byFIG.48, except the radially outwardly extending ends4800are replaced with ends4900that do not extend radially outward. For example, the ends4900can extend axially as illustrated or can extend radially inward.

FIG.50illustrates an exemplary embodiment where the docking station10illustrated byFIG.48or49is deployed in the circulatory system, such as in the inferior vena cava IVC. In the example illustrated byFIG.50, the entire docking station is held in place in the inferior vena cava IVC by the frame350. The sealing portion310provides a seal between the docking station10and an interior surface416of the circulatory system, such as at the junction between the inferior vena cava IVC and the right atrium.

In the example ofFIG.50, the sealing portion(s)310are formed by providing a covering/material over the frame350or a portion thereof. Referring toFIGS.48and49, the sealing portion(s)310can comprise the narrow portion4916, one or both of the tapered portions4918and/or the retaining portion314. In an exemplary embodiment, a covering/material (which can be the same as or similar to other coverings/materials described elsewhere herein) covers the narrow portion4916, the tapered portion4918, and a portion of the retaining portion314. In one embodiment, the covering/material can be configured to encourage or enhance tissue ingrowth (e.g., covering/material can have a large surface area and/or be hydrophilic to enhance tissue ingrowth). This makes the docking station impermeable or substantially impermeable from the sealing portion310to the seal between the valve29and the docking station10at the valve seat18. As such, blood flowing in the inflow direction12toward the outflow direction14is directed to the valve seat18(and valve29once installed or deployed in the valve seat).

As one non-limiting example, when the docking station10is placed in the inferior vena cava IVC, which is a large vessel, the significant volume of blood flowing through the vein is funneled into the valve29by a covering/material. The covering/material can be fluid impermeable or become fluid impermeable (e.g., via tissue ingrowth) so that blood cannot pass through. Again, a variety of other biocompatible covering materials can be used such as any materials described elsewhere herein, including, for example, foam or a fabric that is treated with a coating that is impermeable to blood, polyester, or a processed biological material, such as pericardium. More or all of the docking station frame350can be provided with the covering/material, forming a relatively large impermeable portion.

FIG.51illustrates an exemplary embodiment of a docking station frame350constructed from a coil5100of material. The coil5100can take a wide variety of different forms andFIG.51illustrates just one of the many possible configurations. In the example ofFIG.51, the retaining portion314comprises two relatively larger diameter coil segments5110and a smaller diameter segment5112that forms the valve seat18. However, in other exemplary embodiments, only a single larger diameter coil segment5110may be included. Transition coil segments5114join the smaller diameter segment5112to the larger diameter segment5112.

A covering/material (not shown), such as one of the coverings/materials described elsewhere herein, a cloth, fabric, or a protective foam can be provided inside or outside the coil to provide a sealing portion to the coil5100and create a sealing docking station. Such a covering/material can be connected to the coil or can be deployed separately from the coil5100(e.g., deployed either before or after deployment of the coil5100) and/or with the transcatheter valve29. The valve29expands and is implanted in the smaller diameter segment5112, which forms the valve seat18.

The docking station coil5100can be made from a very resilient or compliant material to accommodate large variations in the anatomy. For example, the docking station coil5100can be made from a highly flexible metal, metal alloy, or polymer. An example of a highly resilient metal is nitinol, but other metals and highly resilient or compliant non-metal materials can be used. The docking station10can be self-expandable, manually expandable (e.g., expandable via balloon), mechanically expandable, or a combination of these. A self-expandable docking station10can be made of a shape memory material such as, for example, nitinol.

FIG.52illustrates the docking station coil5100ofFIG.51implanted in the circulatory system, such as in the inferior vena cava IVC. In the example ofFIG.52, the coil is held in place in the inferior vena cava IVC by a lower larger diameter segment5110. An upper larger diameter segment5110is disposed in the right atrium RA. The larger diameter segment5110can expand to a larger size in the right atrium as illustrated, the larger diameter segments can expand to the same size, or the larger diameter segment in the IVC can expand to a larger size than the larger diameter segment in the right atrium RA. Sealing portion(s)310can be formed by providing the covering/material21(which can be the same as or similar to other coverings/materials described herein) over or inside the frame350or a portion thereof. In an exemplary embodiment, covering/material21covers the smaller diameter segment5112and one or both of the larger diameter segments5110. This can make a docking station10that includes the coil5100impermeable or substantially impermeable from the sealing portion310to the seal between the valve29and the docking station10at the valve seat18. As such, blood flowing in the inflow direction12toward the outflow direction14is directed to the valve seat18(and valve29once installed or deployed in the valve seat).

As one non-limiting example, when the docking station10is placed in the inferior vena cava IVC, which is a large vessel, the significant volume of blood flowing through the vein is funneled into the valve29by a covering or inner layer. The covering can be fluid impermeable or substantially impermeable so that blood or most blood cannot pass through. Again, a variety of other biocompatible covering materials can be used such as any materials described elsewhere herein, including, for example, foam or a fabric that is treated with a coating that is impermeable to blood, polyester, or a processed biological material, such as pericardium. More or all of the docking station frame350can be provided with the covering/material (e.g., an impermeable covering/material), forming a relatively large impermeable portion.

FIGS.53and54illustrate exemplary embodiments of a docking station10. The frame350or body can take a wide variety of different forms andFIG.53illustrates just one of the many possible configurations. A relatively narrower/smaller diameter portion5316forms the seat18. The relatively narrow portion5316can take a wide variety of different forms. For example, the narrow portion5316can be any of the valve seats18disclosed herein, a ring, any conventional stent or frame, etc. In one exemplary embodiment, the inner ends5380themselves act as the valve seat18. In one exemplary embodiment, the narrow portion5316is replaced with a valve/THV29, e.g., the valve is integrated with the docking station structure such that the entire assembly acts as a transcatheter valve and can be implanted as one in the same implantation step.

Referring toFIGS.53and54, spaced apart radially outwardly extending arms5318disposed around a perimeter of the narrow portion5316form the retaining portion314. In the example ofFIG.53, inner ends5380of the arms5318are connected to each other, are positioned adjacent to one another, or are spaced apart, but positioned close to one another. The example illustrated byFIG.54is substantially the same as the example ofFIG.53, except the inner ends5380of the arms5318are connected to ends5381of the narrow portion5316. The docking station can include a variety of combinations and arrangements of arms5318, and can include 2-32 arms (e.g., 2-16 arms) or more arms.

The radially outwardly extending arms5318can take a wide variety of different forms. In the illustrated example, the arms5318comprise upper arms5328and lower arms5338. The docking station can comprise 1-16 upper arms5328(e.g., 1-8 upper arms) or more and can be radially spaced apart evenly or unevenly, and can comprise 1-10 lower arms5338(e.g., 1-8 lower arms) or more and can be radially spaced apart evenly or unevenly. In one exemplary the upper arms5328are coupled to the lower arms5338and/or the inner portion5316such that the upper and lower arms5328,5338are moveable relatively toward and away from one another.

Referring toFIGS.55A-55C, moving the upper arms5328and lower arms5338relatively toward and away from one another increases and decreases the diameter D or width of the docking station10. For example,FIG.55Bcan correspond to a nominal position, such as an average size of an implantation site (e.g., vessel, annulus, etc.) that the docking station will be deployed in. However, any size can be selected.FIG.55Aillustrates that moving5592the arms5328,5338relatively toward one another increases5593the diameter D or width of the docking station. That is, the arms5328extend more in the radial direction5593and less in the axial direction5592(as compared toFIG.55B) and the width or diameter D increases.FIG.55Cillustrates that moving5594the arms5328,5338relatively away from one another decreases the diameter D (as compared toFIG.55B) or width of the docking station10. That is, the arms5328,5338extend less in the radial direction5595and more in the axial direction5594and the width or diameter D of the docking station decreases.

The arms5328,5338can be moved relatively toward and away from one another in a wide variety of different ways. For example, the arms5328,5338can be made from a shape memory alloy with the shape set to the closest spacing between the arms5328,5338(i.e. the largest diameter). Or, a spring can be provided between the arms5328,5338to bias the arms to a desired spacing. When the arms5328,5338are biased to the largest diameter, the docking station10will deploy until the arms engage an inside surface416(e.g., vessel walls, IVC walls, SVC walls, aorta walls, an annulus of a native heart valve, tissue surrounding an annulus of a native heart valve, leaflets, etc.) with enough force to stop expanding and to securely hold the docking station in place.

In one exemplary embodiment, the distance between the arms5328and thus the diameter D or width can be adjusted manually. The distance between the arms5328and thus the diameter D or width can be adjusted manually in a wide variety of different ways. For example, the arms5328,5338can be biased to a first position and an adjustment cord, line or wire5370is coupled to the arms5328,5338to move the arms from the first position. The arms5328,5338can be biased to a first position in a wide variety of different ways. For example, the arms5328,5338can be made from a shape memory alloy with a shape set or the arms can be coupled with a spring, etc. The shape set or spring, etc. can be set to make the spacing between the arms5328and the corresponding arms5338as great as possible, such as a 180 degree angle or approximately 180 degree angle (e.g., ±10 degrees, ±5 degrees) defined between (i.e. extending directly apart in the axial direction). When the arms5328and the arms5338are biased very far apart, the docking station10can be initially deployed in a very narrow configuration. In the narrow configuration, the docking station10can be moved to a selected final deployment site and proper positioning can be checked. Once properly positioned, the diameter D or width can be adjusted with the adjustment cord, line or wire5370. For example, the cord, line or wire5370can be pulled to reduce the spacing between the arms5328and the arms5338and thereby increase the diameter D or width of the docking station10and the strength of engagement with inner surface416(e.g., vessel walls, IVC walls, SVC walls, aorta walls, an annulus of a native heart valve, tissue surrounding an annulus of a native heart valve, leaflets, etc.). Once the docking station10is properly, securely engaged with the inner surface416, the position of the arms5328,5338can be secured to secure the docking station in place. In some embodiments, the shape set or spring, etc. can be set to make the spacing between the arms5328and the corresponding arms5338as small as possible, such as touching each other or with 5, 10, 20, 30 degrees or less defined between (i.e. the arms all extending in the radial or generally radial direction).

In another exemplary embodiment, the distance between the arms5328and thus the diameter D or width can be adjusted manually to both increase the diameter D or width and decrease the diameter or width. For example, adjustment cords, lines or wires5370are coupled to the arms5328,5338such that they can both move the arms toward each other and away from each other. The spacing between the arms5328,5338can be as great as possible during initial deployment, such as a 180 degree angle or approximately 180 degree angle defined between (i.e. extending directly apart in the axial direction). In the narrow configuration, the docking station10can be moved to a selected final deployment site and proper positioning can be checked. Once properly positioned, the diameter D or width can be adjusted with the adjustment cord, line or wire5370. For example, the cord, line or wire5370can be pulled to reduce the spacing between the arms5328,5338and thereby increase the diameter D or width of the docking station10and the strength of engagement with inner surface416(e.g., vessel walls, IVC walls, SVC walls, aorta walls, an annulus of a native heart valve, tissue surrounding an annulus of a native heart valve, leaflets, etc.). Once the docking station10is properly, securely engaged with the inner surface416, the position of the arms5328,5338can be secured to secure the docking station in place.

In the example ofFIGS.53and54, the sealing portion310comprises a covering/material21(which can be the same as or similar to other coverings/materials described elsewhere herein), such as a cloth or fabric or a protective foam provided on the arms5328, the arms5338, or both sets of arms5328,5338. The covering/material (e.g., an impermeable material or semi-permeable material) can extend from the inner ends5380and valve seat18to outer ends5390of the arms5328and/or5338to form the sealing portion310of the docking station10. The valve29can expand and be implanted in the narrow portion5316, which forms the valve seat18. It should be understood that the covering/material can extend three-dimensionally to create a sealing region circumferentially around the valve29when deployed in the circulatory system. For example, the covering/material can have a conical shape, frustoconical shape, funnel shape, other shape, etc. that can guide blood flow to the valve29and inhibit or prevent paravalvular leakage.

The docking stations10illustrated byFIGS.53and54can be made from a very resilient or compliant material to accommodate large variations in the anatomy. For example, the docking station can be made from a highly flexible metal, metal alloy, polymer, or an open cell foam. An example of a highly resilient metal is nitinol, but other metals and highly resilient or compliant non-metal materials can be used. The docking station10can be self-expandable, manually expandable, mechanically expandable, or a combination of these. A self-expandable docking station10can be made of a shape memory material such as, for example, nitinol.

FIG.56illustrates the docking station10ofFIG.53or54implanted in the circulatory system, such as in the inferior vena cava. InFIG.56, the entire docking station is held in place in the inferior vena cava by the arms5328,5338. The covering/material21of the sealing portion310can make docking station10impermeable or substantially impermeable from the sealing portion310to the seal between the valve29and the docking station10at the valve seat18. As such, blood flowing in the inflow direction12toward the outflow direction14flows through the valve seat18(and valve29once installed or deployed in the valve seat).

As one non-limiting example, when the docking station10is placed in the inferior vena cava IVC, which is a large vessel, the significant volume of blood flowing through the vein is funneled into the valve29by the covering or inner layer. The covering can be fluid impermeable or substantially impermeable so that blood cannot pass through. Again, a variety of other biocompatible covering materials can be used such as any materials described elsewhere herein, including, for example, foam or a fabric that is treated with a coating that is impermeable to blood, polyester, or a processed biological material, such as pericardium.

In some exemplary embodiments, the wall368of the frame350of the docking station can have a non-circular shape or non-circular radial cross-section. A wide variety of different non-circular shapes can be implemented.FIG.57illustrates one example of a docking station10having a frame350with a non-circular shape or non-circular radial cross-section. In this example, the expandable docking station10includes one or more sealing portions310, a valve seat18, and one or more retaining portions314. In an alternate embodiment, the docking station10and the valve29can be integrally formed, such that the combination forms a transcatheter valve that can be implanted as one in the same implantation step.

In the example ofFIG.57, the non-circular shape of the frame350allows an axially extending frame with a constant shape or cross section along its length (prior to engagement by an inner surface416) to both engage the interior surface416of the circulatory system and provide a seat18for the valve29. The frame350with a constant axial shape can be configured to provide a valve seat18and an outer engagement surface5710in a wide variety of different ways. In the example ofFIG.57, the frame350has an undulating perimeter5712with alternating inner portions5714and outer portions5716. The frame350can consist only of a wall368having the undulating configuration. However, the frame350can have additional structures, such as a band or other reinforcement for constraining the size of the valve seat18.

The inner and outer portions5714,5716can have a wide variety of different shapes and there can be any number of inner portions5714and outer portions5716. For example, the inner and outer portions5714,5716can be formed by any series of lines and/or curves. In the illustrated embodiment, the frame350has four outer portions5714and four inner portions5716, but the frame can have any number of inner portions and outer portions. For example, the frame350can have any number of inner portions and outer portions5714,5716in the range from 3 to 100.

In the example ofFIG.57, the inner portions5714comprise concave curves and the outer portions5716comprise convex curves. The concave curves and the convex curves are connected together to form a petal shape. However, the inner portions5714and the outer portions can form any shape. For example, increasing the number of inner portions5714and outer portions5716increases a number of points of contact between the frame350and inside surface416of the circulatory system and the number of points of contact between the frame350and the valve29.

The expandable frame350can take a wide variety of different forms. In the illustrated example, the expandable frame350is an expandable lattice. The expandable lattice can be made from individual wires or can be cut from a sheet and then rolled or otherwise formed into the shape of the expandable frame. The frame350can be made from a highly flexible metal, metal alloy, or polymer. Examples of metals and metal alloys that can be used include, but are not limited to, nitinol and other shape memory alloys, elgiloy, and stainless steel, but other metals and highly resilient or compliant non-metal materials can be used to make the frame350. These materials can allow the frame to be compressed to a small size, and then when the compression force is released, the frame will self-expand back to its pre-compressed diameter and/or the frame can be expanded by inflation of a device positioned inside the frame.

The sealing portions310of the docking station10illustrated byFIG.57can take a wide variety of different forms. A covering/material (which can be the same as or similar to other coverings/materials described elsewhere herein) can be attached to a portion of the frame350to form the sealing portion310. For example, the covering/material can cover an end3762as illustrated. In one embodiment, the covering/material can cover (e.g., extend over or fill) the gaps or portions of the gaps between the inner portions5714and outer portions5716. Optionally, the covering/material can extend along the frame wall368. A portion of the frame wall368or the entire frame wall can be covered with the covering/material. However, the sealing portion310can also be formed in a wide variety of other ways.

In the example ofFIG.57, the retaining portion314comprises the wall368of the frame350. A shape set of the wall368biases the outer portions5716radially outward and into contact with the interior surface416(SeeFIG.2) of the circulatory system to retain the docking station10and the valve29at the implantation position. In the illustrated embodiment, the retaining portion314is elongated to allow a small force to be applied to a large area of the interior surface416, which can allow the docking station to be securely held in place without exerting too much radial force on or damaging the interior surface416. For example, the length of the retaining portion314can be twice, three times, four times, five times, or greater than five times the outside diameter of the transcatheter valve.

FIG.58illustrates the docking station10ofFIG.58implanted in the circulatory system, such as in the inferior vena cava IVC. In the example ofFIG.58, the entire docking station is positioned in the inferior vena cava IVC and held in place by the frame350pressing against the inner surface416. As mentioned above, the docking station10can be adapted for use at a variety of different positions in the circulatory system.

FIGS.59A and59Billustrate an exemplary embodiment of a docking station frame350constructed from one or more coils5900of material that are formed into one or more rings5902. The coil5900can take a wide variety of different forms andFIGS.59A and59Billustrates just one of the many possible configurations. In the example ofFIGS.59A and59B, the coil5900is rotated 90 degrees compared to the coil5100illustrated byFIG.51, and is formed into a ring shape, whereas the coil5100is not. The ring(s)5902can be formed by bending one or more wires into a coiled configuration and then wrapping or bending the coil around an axis A of the docking station frame350. The docking station can transition between a collapsed configuration (e.g., for easier, lower-profile delivery to an implantation site) and an expanded configuration (e.g., for securing the docking station in the implantation site and allowing a transcatheter valve to be deployed therein).FIG.59Ashows the docking station transitioning from a collapsed configuration to an expanded configuration.FIG.59Bshows the docking station in an expanded configuration. The interior surface of the coil5900can act as the valve seat for receiving the transcatheter valve. The docking station and coil5900can be formed from any of the materials described as being used to form other frame bodies350elsewhere herein, including nitinol or another shape memory material.

The coil5900can be used to form a docking station10in a wide variety of different ways. A valve seat18can be formed inside or attached to coil5900illustrated byFIGS.59A and59B. Referring toFIG.59C, in another exemplary embodiment, a docking station10is formed from three coils5900or coil portions. The coils5900can be integrally formed, for example, from a single wire or three separate coils5900can be connected or linked together to form a docking station10. In the example ofFIG.59C, the docking station10comprises two relatively larger diameter coil rings5910and a smaller diameter coil ring5912that forms the valve seat18. However, in some embodiments, only a single larger diameter coil ring5910is included.

A covering/material21(See e.g.,FIG.59D), such as a cloth or fabric or a protective foam can be provided inside and/or outside the coil(s)5900(e.g., the coil(s) shown in any ofFIGS.59A-59D) or a portion of the coil(s) to provide a sealing portion to the coil(s)5900and/or one or more coil rings5902,5910,5912, and create a sealed docking station. Such a covering/material can be connected to one or more of the rings5902,5910,5912or can be deployed separately from the coil rings (e.g., deployed either before or after deployment of the coil(s)5900) and/or with the valve/THV29. The valve29(not shown inFIGS.59A-59D) can expand in the center of coil5900ofFIGS.59A-59Bor can expand in the smaller coil ring5912ofFIGS.59C-59D, which forms the valve seat18.

The docking station coil(s)5900and coil ring(s)5902,5910,5912can be made from a very resilient or compliant material to accommodate large variations in the anatomy or any of the materials described elsewhere with respect to the various frame bodies350herein. For example, the docking station coil(s)5900and coil ring(s)5902,5910,5912can be made from a highly flexible metal, metal alloy, or polymer. An example of a highly resilient metal is nitinol, but other metals and highly resilient or compliant non-metal materials can be used. The docking station10can be self-expandable, manually expandable (e.g., expandable via balloon), mechanically expandable, or a combination of these.

FIG.59Dillustrates the docking station10ofFIG.59Cimplanted in the circulatory system, such as in the inferior vena cava IVC. In the example ofFIG.59D, the docking station10is held in place in the inferior vena cava IVC by a lower larger diameter ring5910. An upper larger diameter segment5910is disposed in the right atrium RA. The larger diameter ring5910may expand to a larger size in the right atrium than the ring in the IVC as illustrated, the larger diameter ring in the atrium and IVC may expand to the same size, or the larger diameter ring in the IVC may expand to a larger size than the larger diameter ring in the right atrium RA. Sealing portion(s)310can be formed by providing the covering/material21over or inside one or more of the coil(s)5900and coil ring(s)5902,5910,5912or a portion thereof. In one embodiment, covering/material21covers the smaller diameter ring5912and one or both of the larger diameter rings5110. This can make docking station10impermeable or substantially impermeable from the sealing portion310to the seal between the valve29and the docking station10at the valve seat18. As such, blood flowing in the inflow direction12toward the outflow direction14is directed to the valve seat18(and valve29once installed or deployed in the valve seat).

FIGS.60A-60Jillustrate exemplary embodiments that are similar to the embodiment illustrated byFIGS.3A-3C, except the free ends of the frame350are connected together and/or extend closer together. For example, an end6000of the valve seat18or inner ring is connected to an end6002of the frame350/outer wall368and/or is extended to or toward the end6002of the frame350/outer wall368. The end6000of the valve seat18or inner ring can be connected and/or extended to or toward an end6002of the frame350in a wide variety of different ways.FIGS.60A-60Jillustrate a few of the possible ways that the end6000of the valve seat18or inner ring can be connected and/or extended to or toward an end6002of the frame350.

Connecting the end6000of the valve seat18or inner ring to the end6002of the frame350or extending the end6000of the valve seat18or inner ring to the end6002of the frame350can provide a number of advantages. For example, the docking station10can be more easily loaded in the delivery catheter/sheath, and the docking station10can be more easily recaptured or pulled back into the catheter/sheath if initial placement of the docking station is incorrect, imperfect, or if the medical professional wants to abort or redo the procedure for any reason. Having the bottom/proximal end6000of the valve seat18coupled to the end6002of the frame can help urge the end6000of the valve seat18radially inwardly and into the catheter/sheath. As can be seen, for example, inFIGS.21A-21H, the bottom/proximal end of the valve seat18(identified in these Figures as end2122) tends to extend outwardly even after the outer wall368begins to be compressed radially inwardly. During recapture, the end6002and/or proximal portion of the frame can be first captured and/or retracted further into the delivery catheter/sheath and, by having the bottom/proximal of the valve seat18connected to the end6002of the frame, the retraction and compression of end6002and the connections and/or portions of the frame proximal to the valve seat18can help urge the bottom/proximal end of the valve seat18radially inwardly and into the delivery catheter/sheath. This can also beneficially result in more gradual compression of the valve seat18. Even if the ends are not connected, but end6000merely extends to a location proximate end6002(e.g., such that the valve seat or inner ring or an extension therefrom has a similar length to the outer wall368), this can help with loading, recapture, etc. For example, the longer end or extensions from the valve seat can remain in the catheter/sheath during partial deployment and allow for smoother recapture of the partially deployed docking station. Also, the longer end/extension could help the transition into the catheter/sheath to be more gradual and controlled.

Similarly, the valve seat18or ring of the docking station10can be more uniformly compressed during the crimping process. For example, the compression of the outer wall368before the outer wall368contacts the valve seat18can aid or cause compression of both the proximal and distal ends of the valve seat18or inner ring.

Another advantage of connecting the free ends of the frame350together or connecting end6000and end6002(and/or having the free ends extend closer together) is that it can improve deployment of the docking station and make deployment more controlled. If not connected (or where the unconnected ends are not similarly located/extended or of similar lengths), the docking station can tend to jump or move unpredictably out of the delivery catheter/sheath when the free end (e.g., end2122shown inFIGS.21A-21H) of the valve seat is released from the delivery catheter/sheath. When no longer constrained by the delivery catheter/sheath, the free end (e.g., end2122) can expand suddenly and cause the docking station to jump or move. By connecting the free ends of the docking station frame together or connecting end6000and end6002(and/or by extending the end of the valve seat closer to the end of the outer wall), the expansion of end6000can be more restrained and controlled as it is released from the delivery catheter/sheath such that the docking station deployment is more controlled and less likely to jump, move at all, or as much, i.e., it can prevent or inhibit/restrain jumping or uncontrolled movement of the docking station.

In the example ofFIG.60A(cross-sectional side view) and60B (top end view), the end6000of the valve seat18or inner ring is connected to an end6002of the frame350by one or more lines6010. The line(s)6010can take a wide variety of different forms. For example, the line(s)6010can be a suture(s), a wire(s), rod(s), arm(s), strut(s), or any other elongated member, and can be rigid, semi-rigid, or flexible. In one embodiment, instead of a line(s), a covering/material (e.g., similar to the coverings/materials21described elsewhere herein) extends from end6000to6002(e.g., in a conical or frustoconical shape).

In the example ofFIG.60C(cross-sectional side view) and60D (top end view), the end6000of the valve seat18or inner ring includes an integral extension6020that extends to the end6002of the frame350. In the illustrated embodiment, the extension6020is connected to the end6002of the frame350. In another exemplary embodiment, the extension6020is in substantially the same position as illustrated byFIG.60C, but the extension6020is not connected to the frame. The extension can take a wide variety of different forms. In one exemplary embodiment, a bottom row of cells of the valve seat18or inner ring is elongated and extends (e.g., has apices that extend) to the end6002of the frame350. In one exemplary embodiment, the lattice of struts and cells forming the frame body can continue to form the extension6020.

In the example ofFIG.60E(cross-sectional side view) and60F (top end view), the end6000of the valve seat18or inner ring includes an integral extension6030that is substantially parallel to the outer wall368in cross-section when expanded and extends to a location/length similar to outer wall368. In the example ofFIGS.60E and60F, the extension6030is not connected to the end6002of the frame350. In the example ofFIG.60G(cross-sectional side view) and60H (top end view), the extension6030is in substantially the same position as ofFIG.60E, but the extension6030is connected to the frame by a connecting portion6040. The extension6030can take a wide variety of different forms. In one exemplary embodiment, a bottom row of cells of the valve seat18or inner ring is elongated and extends (e.g., has apices that extend) as shown. The optional connecting portion6040can take a wide variety of different forms. For example, the connecting portion6040can comprise one or more line(s), such as a wire(s), suture(s), rod(s), arm(s), strut(s), and/or a covering/material21.

In the example ofFIG.60I(cross-sectional side view) and60J (top end view), the frame350and seat18are integrally formed and can have a toroidal shape. Referring toFIG.60I, in cross-section the frame350and valve seat18form a loop or loops6050. In one exemplary embodiment, the loop6050is formed of a continuous lattice of struts and cells. However, the loop(s) can be formed in a wide variety of different ways.

In various figures herein, a “V” or generic valve symbol is used to represent generically a variety of valves that can have different structures for closing/opening the valve and can operate in different ways.FIGS.61-65illustrate a few examples of the many valves or valve configurations that can be used. Any valve type can be used and some valves that are traditionally applied surgically can be modified for transcatheter implantation. A transcatheter valve can be expanded in a variety of ways, e.g., it can be self-expanding, expanded with a balloon, mechanically-expandable, and/or a combination of these. In one example, a mechanical opening mechanism, such as a hinged mechanism can be used to expand the transcatheter valve and/or a frame of the transcatheter valve can comprise a hinged mechanism.FIG.61illustrates an expandable valve29for transcatheter implantation that is shown and described in U.S. Pat. No. 8,002,825, which is incorporated herein by reference in its entirety. An example of a tri-leaflet valve is shown and described in Published Patent Cooperation Treaty Application No. 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. Pat. 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. Pat. No. 6,558,418, which is incorporated herein by reference in its entirety.FIGS.62-64illustrate an exemplary embodiment of an expandable tri-leaflet valve29, such as the Edwards SAPIEN Transcatheter Heart Valve. The valve29can comprise a frame712that contains a tri-leaflet valve4500compressed inside the frame712.FIG.63illustrates the frame712expanded and the valve29in an open condition.FIG.64illustrates the frame712expanded and the valve29in a closed condition.FIGS.65A,65B, and65Cillustrate an example of an expandable valve29that is shown and described in U.S. Pat. No. 6,540,782, which is incorporated herein by reference in its entirety. Another example of a valve is shown and described in U.S. Pat. No. 3,365,728, which is incorporated herein by reference in its entirety. Another example of a valve is shown and described in U.S. Pat. No. 3,824,629, which is incorporated herein by reference in its entirety. Another example of a valve is shown and described in U.S. Pat. No. 5,814,099, which is incorporated herein by reference in its entirety. Any of these, the valves described in the incorporated references, or other valves can be used as valve29in the various embodiments herein.

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

Referring toFIGS.66A through72C, exemplary docking station deployment assemblies/systems7000for deploying a docking station/device are depicted. The various docking station deployment assemblies/systems7000herein can be used with any of the docking stations/devices described or depicted in this disclosure (e.g., those shown inFIGS.2A-36,42-60J, and), which can be modified as appropriate. The docking deployment assemblies/systems7000(e.g., docking station deployment assembly, docking station deployment system, docking device deployment assembly, etc.) can include a catheter2200defining a lumen or delivery passage2202with an inner surface2203and having a distal opening2206(optionally, a proximal opening2204as well), a docking station frame350capable of being radially compressed and expanded, and a pusher or other retention device2300having a distal end2302and an outer circumferential surface2304. The docking deployment assemblies/systems can also include a handle connected to a proximal end of the catheter2200. The handle can include controls (e.g., knobs, buttons, switches, etc.) for adjusting the assembly/system.

The docking deployment assemblies/systems herein can also (or as an alternative to the pusher) include an inner shaft or inner catheter. The inner shaft/catheter can extends inside the catheter2200, the docking station, and/or the pusher. The inner shaft/catheter can include a nose cone (e.g., a flexible nose cone) to aid in navigation to the target deployment site in the body. The inner shaft/catheter can include a guide wire lumen so the docking deployment assembly/system can more easily be advanced to the target deployment site. The proximal end of the inner shaft/catheter can connect to the handle.

The pusher2300can be made of any semi-flexible or flexible material that can pass or wind through the catheter2200(e.g., when the catheter is positioned in the body and the catheter includes multiple turns in different directions along the anatomy) and exert a distal force at the distal end2302of the pusher2300. The pusher2300can be hollow, a tube, a coil, and/or can be solid or have a solid cross-section. The pusher2300can have no lumen or have one or more lumens, etc. The frame350of the docking station10can be made from any combination of the materials disclosed herein. For example, the docking station10and its components can be made from a shape memory alloy frame, foam, fabric coverings, a combination of these, etc. The docking station frame350can also take any shape, form, or configuration disclosed herein. The docking station frame350, when in a compressed state, and the pusher2300can be receivable in the lumen/delivery passage2202of the catheter2200with the docking station frame350near the distal opening2206of the catheter2200and the pusher2300proximal of the docking station or relatively closer to the proximal end. The distal end2302of the pusher2300can be disposed in abutting contact with or near a proximal end315of the docking station frame350, and a distal end317of the docking station frame350can be disposed within the lumen/delivery passage2202of the catheter2200. At least a portion of the pusher2300can be sized to have a diameter that is at least as large as an inner diameter of the docking station frame350when in the compressed state.

Turning toFIGS.66A and66B, the docking station frame350and pusher2300can be disposed in the catheter2200such that a distal movement of the pusher2300(i.e., movement toward the distal opening2206of the catheter2200) will apply a distal force to the proximal end315of the docking station frame350, moving the proximal end315of the frame350toward the distal opening2206of the catheter2200. As shown inFIG.66A, as the docking station frame350is moved distally through the lumen/delivery passage2202(or the catheter2200is retracted proximally over the frame350), the distal end317of the frame350moves distally past the distal opening2206of the catheter2200and the distal portion of the frame350that is outside the catheter2200will begin to expand radially outwardly. The portion of the frame350outside the catheter2200will expand radially outwardly to a diameter greater than that of the catheter2200and the portion of the frame350within the catheter2200will remain in the compressed state. As shown inFIG.66B, once the pusher2300distally pushes the frame350past the distal opening2206of the catheter2200(or the distal opening2206of the catheter2200is proximally retracted beyond the frame350), the frame350will be distally past the distal opening2206of the catheter2200and will be fully radially expanded in the desired position.

Optionally, instead of having pusher2300be advanced/advanceable axially through the catheter2200to push the docking station/device out of the catheter2200, the pusher2300can be configured as an inner shaft or inner catheter (or be replaced by an inner shaft or inner catheter) that remains stationary (e.g., relative to a handle). The inner shaft/catheter can include, or have attached thereto, a retention device to hold the docking station/device until a desired time (e.g., until full deployment). Instead of a pusher being advanced through the catheter2200, the catheter2200(e.g., a retention sheath, delivery capsule, outer sheath, etc.) can be retracted to release and deploy the docking station/device. This type of deployment assembly/system can be otherwise similar to those discussed elsewhere herein and include features and/or components of other deployment assembly/systems herein (e.g., those shown inFIGS.66A-72C).

Referring toFIGS.12and67through72C, the pusher or retention device2300and/or docking station frame350of the docking deployment assembly/system7000can be sized, shaped, tethered, or otherwise designed such that the positioning of the frame350is maintained or otherwise controlled while deploying the frame350until the frame350is fully released from the catheter2200. In one embodiment, the frame350is retained by or otherwise connected to the catheter2200, the pusher2300, inner shaft/catheter, and/or a retention device even after the frame350has completely radially expanded. The frame350can then be released from the catheter2200, pusher2300, inner shaft/catheter, and/or a retention device once the docking station frame350has completely radially expanded. The position of the frame350can be maintained in various ways.

Turning back toFIG.12and toFIG.68A, the docking station frame350can include at least one leg or extension319or multiple legs/extensions319. The legs/extensions319can be proximal legs/extensions that extend from a proximal end of the frame350. Each proximal leg/extension319can be a singular rod which extends proximally (e.g., toward the pusher2300or retention device when the frame350is disposed in the catheter2200) beyond other parts (e.g., beyond all other parts) of the docking station frame350. In one embodiment, multiple proximal legs/extensions319are evenly spaced around the circumference of the frame350and extend proximally (e.g., longitudinally, axially, downward) from the proximal most struts1200. Each proximal leg/extension319can include an end shape or foot321at an end (e.g., the proximal end) of the leg/extension319. Each proximal shape/foot321can extend circumferentially, radially inwardly, and/or radially outwardly farther than the proximal leg/extension319. In one embodiment, the proximal shape/foot321is substantially spherical or otherwise bulbous. However, it will be appreciated that the end shapes or feet321can be any shape or size receivable within a corresponding tab or slot in the pusher2300or other retention device, as described below. For example, the end shapes/feet321can be rectangular, elongated, pyramidal, triangular, slotted, grooved, hollow, ring-like, or any other design known in the art.

While the proximal legs/extensions319have been described as being a part of the frame350ofFIG.12, it will be appreciated that the proximal legs/extensions319can be incorporated into any of the docking station frames350disclosed herein. For example, proximal legs/extensions can be included at the proximal end of the docking station frames350ofFIG.25or26, or any other frame350described herein.

Turning toFIG.67, an exemplary distal end2302of a pusher2300or other retention device (e.g., if no pusher is used) is depicted. The illustrated pusher2300(or retention device) includes a plurality of slots or tabs2306in the outer circumferential surface2304of the pusher2300(or retention device) and disposed around the distal end2302of the pusher2300(or retention device). Each of the slots2306can be sized, shaped, or otherwise designed to retain a proximal leg/extension319and/or end shape/foot321of the frame350when the frame350and pusher2300(or retention device) are disposed within the catheter2200. In one embodiment, the number, size, and shape of the slots2306corresponds to the number, size, and shape of the proximal legs/extensions319and/or end shapes/feet321of the docking station frame350.

Before deployment of the docking station and frame350, the docking station and frame350can be inserted into the catheter2200with the ends/feet321and proximal legs/extensions319of the docking station or frame350being disposed within the slots2306of the pusher2300or retention device. In one embodiment, the outer circumferential surface2304of the pusher2300or other retention device, the slots2306, the proximal legs/extensions319, and the ends/feet321are sized such that the proximal ends/feet321can be retained within the slots2306and between the pusher2300or other retention device and the inner surface2203of the catheter2200when disposed within the catheter2200. In some embodiments, pusher2300moves or can move distally out of the catheter2200to push the docking station and its frame350distally out of the distal opening2206. In some embodiments, the catheter2200(e.g., an outer sheath, sleeve, delivery capsule, etc.) is retracted to uncover and release the docking station and its frame350. For a self-expandable frame, as the docking station or frame350is uncovered (e.g., by retracting the catheter2200and/or pushing it out of the catheter2200), the uncovered portions begin to radially expand.

While the slots2306are still within the catheter2200, the position of the frame350can be maintained or otherwise controlled, as the proximal feet321will still be retained within the catheter2200. As such, the frame350can substantially expand radially outward while a portion of the frame350can be maintained or otherwise controlled by the catheter2200, pusher2300, inner shaft/catheter, and/or retention device. Once a substantial portion of the slots2306have moved distally past the distal opening2206of the catheter2200, the proximal feet321can be released from the slots2306and the positioning of the frame350can be set. Self-expansion of the frame350can cause the extensions/legs and ends/feet to move radially out of the slots when uncovered.

Optionally, the pusher or other retention device can comprise or be configured as a lock and release connector similar to that shown and described in PCT Patent App. No. PCT/US2018/040337, filed Jun. 29, 2018, and U.S. Provisional Patent App. No. 62/527,577, filed Jun. 30, 2017, each of which is incorporated by reference in their entirety herein. The lock and release connector can comprise a body and a door (or, optionally, multiple doors) engaged with the body, wherein the at least one door (or each of the multiple doors) is moveable from a first position to a second position. The door can be integral with the body or connected to the body. The door can be constructed in a variety of ways and can comprise a variety of different materials. The lock and release connector can further comprise one fastener or multiple fasteners connecting at least one portion or end of the door to the body.

The docking station/device and frame350can have one or more extensions/legs and can be disposed in the catheter2200. If an inner shaft/catheter is used, the lock and release connector can be connected to the inner shaft/catheter. Slots2306can be formed between the body and the door. An extension/leg of the docking station and frame can be interposed between the body and the door (e.g., in a slot). Optionally, the lock and release connector can further comprise a second door, and a second extension/leg of the docking station and frame can be interposed between the body and the second door. The body can be hingedly connected to the door(s).

The catheter2200with the docking station therein can be positioned at a target delivery site. The catheter2200can be retracted or the frame pushed out of the catheter2200until a distal end of the docking station or frame is positioned outside the catheter2200. The catheter2200can further be displaced (e.g., withdrawn, etc.) with respect to or relative to the docking station and the lock and release connector until the door(s) open and release the extension(s) from between the body and the door. The door(s) can be biased (e.g., include a spring, etc.) to cause the door(s) to open when the catheter2200no longer covers the door to help release the extension.

Referring toFIG.68AthroughFIG.72C, three exemplary docking deployment assemblies/systems7000are depicted which permit a user to maintain or otherwise control the position of frame350once frame350has been fully radially expanded outside the catheter2200.

Turning toFIG.68AthroughFIG.70, an exemplary docking station deployment assembly7000is shown. The frame350includes at least one elongated leg/extension323disposed at the proximal end of the frame350and attached or otherwise secured to a proximal strut1200. Each elongated leg/extension323can include a foot/end shape325at the proximal end of the elongated leg/extension323. Each end/foot325can extend circumferentially, radially inwardly, and/or radially outwardly farther than the elongated leg/extension323. In one embodiment, the end/foot325is substantially spherical or otherwise bulbous. However, the end/foot325can be any shape or size receivable within a corresponding tab or slot in the pusher2300or other retention device. For example, the end/foot325can be rectangular, elongated, slotted, grooved, hollow, ring-shaped, or any other design known in the art. The frame350can also include proximal legs/extensions319and end shapes/feet321as previously described. In one embodiment, the elongated leg/extension323is included on the frame350in place of one of the proximal legs/extensions319and the elongated leg/extension323extends longitudinally farther away from the remainder of the frame350than the proximal legs/extensions319. While the illustrated embodiments depict the frame350as having only one elongated leg/extension323, more than one elongated leg/extension323can be included.

The at least one elongated leg/extension323of the frame350can take a variety of forms. As shown inFIGS.69A and69B, the at least one elongated leg/extension323of the frame350can be flexible, like a flexible rod (FIG.69A), or rigid, like a rigid rod (FIG.69B). The inclusion of a flexible (e.g., spring-like, coiled, thinned, slotted, etc.) elongated leg/extension323can permit the frame350to extend smoothly out of the catheter2200as the frame350radially expands as it is distally moved out of the catheter2200. For example, after the proximal legs/extensions319have been released from the slots2306but while the end/foot325is still retained in the elongated recess or slot2308within the catheter2200, the flexible (e.g., spring-like, etc.) elongated leg/extension323can flex, expand, or otherwise adjust to correspond to (or such that a portion thereof corresponds to) the radial expansion of the frame350. The inclusion of a rigid (e.g., rod-like, etc.) elongated leg/extension323can permit the frame350to be positioned or otherwise moved once the frame radially expands as it is distally moved out of the catheter. For example, after the proximal legs/extensions319have been released from the slots2306but while the end/foot325is still retained in the slot2308, the rigid elongated leg/extension323can securely retain the frame350to the pusher2300, retention device, inner shaft/catheter, and/or catheter2200such that the frame350can more easily be positioned or otherwise moved after expansion. However, it will be appreciated that the elongated leg/extension323can take other forms. For example, the elongated leg/extension323can be curved, twisted, bent, or otherwise shaped according to the desired deployment and/or control of the frame350out of the catheter2200.

As shown inFIG.70, the distal end2302of the pusher2300or other retention device can include at least one elongated slot2308in the outer circumferential surface2304of the pusher2300or other retention device. The at least one elongated slot2308can be sized and shaped to correspond to the size and shape of the elongated leg/extension323(or a portion thereof) and/or end/foot325of the frame350. The pusher2300or other retention device can optionally include one or more additional slots2306(e.g., in the outer circumferential surface2304of the pusher2300or other retention device, between a body and door(s)/latch(es), etc.). The optional one or more elongated slots2308and one or more shorter slots2306can extend from the distal end2302of the pusher2300or other retention device toward the proximal end of the pusher2300or other retention device (e.g., axially or parallel to a longitudinal axis). In one embodiment, the one or more slots2308extend proximally farther from the distal end2302of the pusher2300or other retention device than the one or more optional slots2306.

Before deployment of the frame350, the frame350(and, optionally, a pusher) can be inserted into the catheter2200with the proximal ends/feet321and proximal legs/extensions319of the frame350being directed proximally. The ends/feet321and/or proximal legs/extensions319(e.g., a portion thereof) of the frame350can be disposed within the slots2306of the pusher or retention device2300. In one embodiment, the outer circumferential surface2304of the pusher or retention device2300, the slots2306, the slots2308, the proximal legs/extensions319, the proximal ends/feet321, the elongated legs/extensions323, and the ends/feet325are sized such that the ends/feet321can be retained within the slots2306(e.g., between the pusher or retention device2300and the inner surface2203of the catheter2200or between the body of the retention device and a door/latch) and the one or more ends/feet325of the one or more elongated legs/extensions323can be retained within the slots2308(e.g., between the pusher or retention device2300and the inner surface2203of the catheter2200or between the body of the retention device and a door/latch) when the pusher or retention device2300and one or more ends/feet are disposed within the catheter2200.

As the docking station/device moves out of the catheter2200, the frame350exits the distal opening2206and the frame350begins to expand. While at least one extension/leg (e.g., a portion thereof) and/or end/foot is still retained within the catheter2200(e.g., in a retention device), the position of the frame350can be maintained or otherwise controlled. As such, the frame350(e.g., progressively the distal end, then other distal portions of the frame, then the middle of the frame, then proximal portions, and substantially all of the frame) can be substantially expand radially outward while a portion of the frame350(e.g., one or more extensions/legs, a portion(s) thereof, and/or one or more feet/end(s) thereof) is maintained or otherwise controlled by the catheter2200and/or pusher or retention device2300.

In one embodiment, where the retention device (e.g., pusher) includes at least one elongated slot2308and at least one shorter slot2106, after all or most of the shorter slot(s)2306have moved distally past the distal opening2206of the catheter2200(e.g., is uncovered by retraction the catheter or advancing a shaft or pusher), one or more ends/feet321are released from the slot(s)2306and frame350is fully radially expanded (e.g., expanded until in contact with the circulatory system). Even after shorter slot(s)2306have moved distally past the distal opening2206of the catheter2200, the at least one end/foot325of at least one elongated leg/extension can still be retained within the elongated slot2308(e.g., all or a portion thereof). As such, the frame350can completely radially expand and the position of the frame350can be maintained or otherwise controlled by the retention of the elongated leg/extension323and/or end/foot325within the catheter2200. Once all or most of the at least one elongated slot2308is uncovered or moves distally past the distal opening2206of the catheter2200(e.g., is uncovered by retraction of the catheter or advancing a shaft or pusher), the at least one end/foot325can be released from the at least one elongated slot2308and the positioning of the frame350can be set. If a door/latch is used over any of the slot(s), the door opens to allow the end/foot thereunder to be released.

In one embodiment, where the retention device (e.g., pusher) includes only one elongated slot2308, as the frame350moves distally past the distal opening2206of the catheter2200(e.g., is uncovered by retraction the catheter or advancing a shaft or pusher), the frame350is progressively expanded from distal to proximal until fully radially expanded (e.g., expanded until in contact with the circulatory system). Even after all but the end/foot325of frame350has moved distally past the distal opening2206of the catheter2200, the end/foot325of the elongated leg/extension can still be retained within the elongated slot2308(e.g., all or a portion thereof). As such, the frame350can completely radially expand and the position of the frame350can be maintained or otherwise controlled by the retention of the elongated leg/extension323and/or end/foot325within the catheter2200. Once all or most of the elongated slot2308moves distally past the distal opening2206of the catheter2200(e.g., is uncovered by retraction of the catheter or advancing a shaft or pusher), the at least one end/foot325can be released from the at least one elongated slot2308and the positioning of the frame350can be set. If a door/latch is used over the slot2308, the door opens to allow the end/foot325thereunder to be released.

Having only one extension/leg or only one elongated extension/leg323on a self-expandable frame acts to help prevent the frame from jumping out of the distal end of the catheter and throwing off the placement. As the proximal end315of the frame350approaches the distal opening2206of the catheter, forces can build between the proximal end315and distal opening2206that can cause the frame to jump forward out of the catheter. Having multiple legs/extensions at the proximal-most end of the frame350can make jumping more likely, as the legs/extensions can act against each other and create opposing forces against the distal end of the catheter. By having the proximal end315of the frame350have only one elongated extension/leg323(e.g., with or without shorter extensions/legs319) or only one extension/leg at all (e.g.,319or323), the frame350is allowed to fully expand while retained by only one extension/leg, then this one remaining extension/leg can release the frame350without causing jumping.

Turning toFIGS.71A through71C, an exemplary docking device deployment assembly7000is shown. The docking device deployment assembly7000can be similar to those described above and alternatively or additionally include a suture or retaining line2700which can be used to maintain the position of the frame350as the frame350is deployed from the catheter2200and fully radially expanded. The inner shaft, retention device, or pusher2300is shown as including two suture passages2310which extend longitudinally through the inner shaft, retention device, or pusher2300and which each can receive a portion or an end of the suture2700; however, only a single passage can be used. In one embodiment, the suture2700is threaded through one of the suture passages2310, around a portion of the frame350, and back through the other suture passage2700such that both ends of the suture2700extend through the proximal portion of the catheter2200. The suture2700can be secured around any portion of the frame350. In one embodiment, the suture2700is looped around one or more struts1200or apexes of struts of the frame350. In another embodiment, the frame (e.g., apexes of the frame) includes one or more loops, apertures, holes, etc. that the suture2700can be threaded through.

In one embodiment, the pusher2300is used to apply a distal force on the frame350to move the frame350distally through the distal opening2206of the catheter2200while the suture2700applies a proximal force on the frame350to keep the frame350in contact with and/or proximate the pusher2300(e.g., by holding the suture or pulling proximally on the suture). As shown inFIG.71A, once the pusher2300pushes a portion of the frame350through the distal opening2206of the catheter2200, the portion of the frame350extending beyond the distal opening2206will begin to expand radially outward, and the proximal force applied by the suture2700will keep the frame350(e.g., a proximal end of frame350) in contact with and/or proximate the pusher2300. InFIG.71B, once the pusher2300has pushed the frame350completely through the distal opening2206, the frame350can be fully radially expanded and the proximal force applied by the suture2700on the frame350will maintain the frame350proximate the distal end of the pusher2300and/or catheter2200. InFIG.71C, once the frame has been fully radially expanded in the desired position, the suture2700can be removed from the suture passage(s)2310and frame350such that the expanded frame350is deployed in the desired position.

In one embodiment, the suture2700applies a proximal force on the frame350to keep the frame350in contact with and/or proximate the inner shaft, retention device, or pusher2300(e.g., by holding the suture or pulling proximally on the suture) as the catheter2200(e.g., outer sheath, delivery capsule, sleeve, etc.) is withdrawn. As shown inFIG.71A, once the catheter is retracted such that a portion of the frame350is exposed, the portion of the frame350extending beyond the distal opening2206expand radially outward, and the proximal force applied by the suture2700will keep the frame350(e.g., a proximal end of frame350) in contact with and/or proximate the inner shaft, retention device, or pusher2300. As shown inFIG.71B, once the catheter has been completely retracted from over the frame350, the frame350is fully radially expanded and the proximal force applied by the suture2700on the frame350can maintain the frame350proximate the distal end of the inner shaft, retention device, or pusher2300and/or catheter2200. As shown inFIG.71C, once the frame has been fully radially expanded in the desired position, the suture2700can be removed from the suture passage(s)2310and frame350such that the expanded frame350is deployed in the desired position.

While this exemplary docking station deployment assembly7000has been described and depicted as including only a suture2700(e.g., no extensions/legs are necessary) to maintain the position of the frame350after the frame350has been fully radially expanded, other features can also be included to maintain the position of the frame350after the frame350has been fully radially expanded. For example, the frame350can include proximal legs/extensions319and proximal ends/feet321and/or one or more elongated legs/extensions323and one or more ends/feet325and the pusher/inner shaft/retention device can include shorter slots2306and/or one or more elongated slots2308to maintain the position of the frame350after the frame350has been fully radially expanded, as described above.

Turning toFIGS.72A through72C, an exemplary docking station deployment assembly7000is shown. In the illustrated embodiment, the pusher/inner shaft/retention system2300includes a distal portion having a first outer circumferential surface2312and a proximal portion having a second outer circumferential surface2314. The distal portion and the proximal portion can be integrally formed or the distal portion327can be a separate component, such as a pin, that is attached to the proximal portion or extends through a lumen of the proximal portion. In one embodiment, a pin is used as surface2312without any larger diameter proximal portion. The pin and/or distal portion can include a lumen through which another portion of the system and/or a guidewire can pass. The distal end2302of the distal portion can optionally be tapered or otherwise rounded. The first outer circumferential surface2312of the pusher/retention system2300is narrower than or have a smaller diameter than the inside diameter of the frame350(or have the same or a similar diameter) when the frame350is in the compressed state within the catheter2200and the second outer circumferential surface2314of the pusher/retention system2300can be wider or have a larger diameter than the inside diameter of the frame350when the frame350is in the compressed state and be narrower or have a smaller diameter than the inner surface2203of the catheter2200. For example, the frame350can be crimped around the outer circumferential surface2312. In one embodiment, the first outer circumferential surface2312has a large enough diameter to retain a proximal portion of the frame350in abutting contact with the inner surface2203of the catheter2200.

In use, when the pusher/inner shaft/retention system2300and frame350are disposed within the catheter2200, the distal portion second outer circumferential surface2314of the pusher2300can abut the proximal end315of the frame350and the distal portion of the first circumferential surface2312(e.g., a narrowed portion, a pin, etc.) will be disposed within the inner diameter of the compressed frame350. Within the catheter2200, the first circumferential surface2312and the inside surface2203can trap or constrain a portion of the frame350that is within the catheter2200therebetween. A user can use the pusher/retention system2300to apply a distal force on the frame350to move the frame350distally through the distal opening2206of the catheter2200and/or can retract the catheter2200from over the frame350.

In one embodiment, as shown inFIG.72A, the pusher/inner shaft/retention system2300can be used to push a portion of the frame350through the distal opening2206of the catheter2200, and the portion of the frame350extending beyond the distal opening2206begins to expand radially outward. In one embodiment, also represented byFIG.72A, the catheter2200can be retracted proximally from over the frame350, and the portion of the frame350extending beyond the distal opening2206expands radially outward. As shown inFIG.72B, as long as any portion of the frame350remains in the catheter2200, the first circumferential surface2312of the pusher/inner shaft/retention system2300and the inside surface2203can trap, constrain, or pinch a portion (e.g., at least a proximal portion) of the frame that is in the catheter. This can help prevent or inhibit the expansion force of the frame350from causing the frame350to jump and/or exit the catheter2200before the transition or step between the outer circumferential surface2314and the inner circumferential surface2314reaches the end of the catheter2200. As such, the frame350will have been maintained in position throughout the deployment of the frame350from the catheter2200. As shown inFIG.72C, when the frame350is entirely outside the distal end of the catheter2200, the frame350can fully radially expand and be deployed in the desired target position. The pusher/inner shaft/retention system2300can be retracted from the frame350and pulled back into or be re-covered by the catheter2200.

In one embodiment, docking station deployment assembly7000includes only a pusher/inner shaft/retention system2300with first and second circumferential surfaces to maintain the position of the frame350after the frame350has been fully radially expanded. However, in some embodiments, other features are included to maintain the position of the frame350after the frame350has been fully radially expanded. For example, the frame350can include proximal legs/extensions319and proximal ends/feet321and/or one or more elongated legs/extensions323and one or more ends/feet325and the pusher/retention system2300can include shorter slots2306and or one or more elongated slots2308, and/or the docking station deployment assembly7000can include a suture2700to maintain the position of the frame350after the frame350has been fully radially expanded, as described above. Especially where other retention features (e.g., extensions and slots, doors/latches, sutures, etc.) are used, the distal portion or pin (e.g., surface2312) need trap the frame350and can have a smaller diameter than the inner surface of the frame.

The distal portion or pin with surface2312acts to help prevent a self-expandable frame from jumping out of the distal end of the catheter and throwing off the placement. As the proximal end315of the frame350approaches the distal opening2206of the catheter, forces can build between the proximal end315and distal opening2206that can cause the frame to jump forward out of the catheter. These forces make jumping more likely, and this is especially true when the proximal end315of the frame is angled radially inwardly relative to the inner surface of the catheter2200. For example, as more of the frame350expands outside the catheter, the proximal end315remaining in the catheter tends to angle radially inwardly and can build up pressure against the distal opening2206and this can flip or spring the frame350out of the catheter as the proximal end tries to expand. By having the distal portion or pin with surface2312inside the proximal end315of the frame350, the proximal end315is prevented from angling too much out of parallel (e.g., helps the proximal end315to remain parallel, nearly parallel, or more closely parallel) relative to the inner surface of the catheter2200as the frame expands, and this can help prevent or inhibit the frame350from jumping out of the distal end of the catheter2200.

Referring now toFIGS.73A through75B, the frame350can include a sealing material or cover/covering8000disposed on the end362of the frame350to effectuate a seal between the valve29and interior surface416of the circulatory system when the valve29is disposed in the valve seat18of the frame350and the frame350is radially expanded and placed in the body. The cover8000can be a cylinder or substantially a cylinder rolled partially backward on itself and can have an end8002having an inside diameter8004, an outside diameter8006, a distal surface8008, and a proximal surface8010. The cover8000can comprise a single sheet of PET (Polyethylene terephthalate), PTFE, ePTFE, another polymer, or other biocompatible material which can provide an effective seal. In one embodiment, the cover8000can comprise a woven ribbon or fabric, such as a woven ribbon or fabric that comprises PET, PTFE, ePTFE, another polymer, or other biocompatible material.

As shown inFIGS.74A through75B, the cover8000can be disposed over the end362of the frame350. The cover8000can be secured to the frame350in a wide variety of different ways. For example, the cover8000can be attached to the frame with sutures, adhered, tied, fused, etc. Turning toFIGS.74A and74B, the cover8000can be placed onto the end362of the frame350. In one embodiment, the end8002of the cover8000abuts the end362of the frame350. The inside diameter8004of the cover8000is radially inward of and adjacent to the inside diameter364of the frame350. The outside diameter8006the cover8000is radially outward of and adjacent to and adjacent to the outside diameter366of the frame350. The proximal surface8010of the cover8000can extend around a portion of the retaining portions314of the frame350. In one embodiment, the outside diameter8006of the cover provides a secure fit and/or seal between the frame350and the interior surface416of the circulatory system.

Referring toFIGS.75A and75B, the cover8000can be draped or otherwise disposed entirely around the end362of the frame350. The cover8000can have contours or otherwise undulate between the struts1200of the frame350(FIG.75A) or the cover8000can be flush with the end362of the frame3530(FIG.75B). A valve29(See e.g.FIG.63) can be inserted into the valve seat18defined by the inside diameter364of the frame350and the inside diameter8004of the cover8000. In such a configuration, the cover8000can effectuate a continuous seal between the outside diameter366of the frame350and the interior surface416of the circulatory system, around the end362of the frame350, and between the inside diameter364of the frame350and the valve29. For example, when the valve29is in the closed position, the valve29and the cover8000provide a seal against blood flow.

Referring, for example, toFIGS.25,26, and76, the frame350can also include one or more friction-enhancing features, such as barbs2518shown inFIG.76projecting radially outwardly from the retaining portion314of the frame350. The barbs2518can be curved and/or otherwise oriented to prevent the frame350from moving from an installed position. In one embodiment, the barbs2518project radially outwardly from one or more struts1200. As shown inFIG.76, when the frame350is deployed and expands radially outwardly, the barbs2518can insert into the interior surface416of the circulatory system to secure or otherwise maintain the position of the frame2518. The barbs2518can be oriented such that the frame350does not move due to the force of blood flowing through the heart or other portions of the body (e.g., angled or curved to point in the direction of blood flow). Any frame350described or depicted herein can include similar barbs2518.

As mentioned above, the docking station10can be adapted for use at a variety of different positions in the circulatory system.FIGS.77and78illustrate exemplary embodiments where a docking station10is configured for use in the aorta900. InFIG.77, the docking station10is shown used alone in the aorta. InFIG.78, the docking station10is shown used in conjunction with a graft902. The docking station10used in the aorta900can take a wide variety of different forms. For example, the docking station10shown inFIGS.77and78can be any of the docking stations10disclosed herein.

Referring toFIGS.77and78, the docking station can be placed in the aorta900and an extension950extends to stabilize the docking station10. InFIG.77, the docking station10is placed inside the annulus of the aortic valve AV and the extension950extends into the aorta, such as into the aortic arch. InFIG.11, the docking station10is placed inside the annulus of the aortic valve AV and the extension950extends into the aorta, such as into the graft902. However, the extension950and the graft902can take a wide variety of different forms. The graft can be a surgically installed graft or a graft that is installed through a catheter, without open heart surgery. In one exemplary embodiment, the extension acts as a graft.

The extension950can take a wide variety of different forms. In one exemplary embodiment, the extension950is constructed to allow blood to freely flow through the extension. For example, the extension950can be an open cell frame. The extension950can comprise spring elements3700. The extension950can comprise wires. In one exemplary embodiment, the extension950comprises an open cell frame, spring elements3700, and/or wires. In the illustrated embodiment, the extension950is configured to bend as it extends in the aorta. The extension950can be integrally formed with the docking station10or the extension can be made separately from the docking station10and attached to the docking station. Optionally, the extension950can be configured as a graft or stent-graft.

Referring toFIGS.77and78, when the docking station10is placed in the aorta, a significant volume of blood flowing through the aorta can be directed into the valve29by a covering/material21. The covering/material21can be the same as or similar to other coverings/materials described herein. The covering/material can be fluid impermeable or substantially impermeable so that blood cannot pass through. More or all the docking station frame350can be provided with the covering/material21, forming a relatively large impermeable or substantially impermeable portion.

The foregoing primarily describes embodiments of docking stations that are self-expanding. But the docking stations shown and described herein can be modified for delivery of balloon-expandable, mechanically-expandable docking devices, and/or a combination of these, within the scope of the present disclosure. Delivering balloon-expandable and/or mechanically-expandable docking stations, etc. to an implantation location can also be performed.

A variety of methods of implanting the docking stations and valves described herein can be used. Steps described herein can be used in various orders and the various steps can be combined or omitted. As one example, a method can include: inserting a docking station delivery catheter/sheath into vasculature (or a circulatory system) of a patient, the docking station holding a docking station in a compressed configuration; navigating the docking station delivery catheter/sheath through the vasculature (or circulatory system) to a desired implantation location/site; deploying/releasing the docking station such that it expands to an expanded configuration and engages an interior surface of the circulatory system, vasculature, heart, etc.; inserting a valve delivery catheter (e.g., a THV delivery catheter) into the vasculature (or circulatory system), the valve delivery catheter holding a transcatheter valve in a compressed configuration; navigating the valve delivery catheter through the vasculature (or circulatory system) to a desired implantation location/site or to the docking station (e.g., within the docking station or within a valve seat of the docking station); deploying/releasing the valve such that it expands to an expanded configuration and engages an interior surface of the docking station or of the valve seat of the docking station and is securely held thereby; (expanding can be done by allowing the transcatheter valve to self-expand out of the catheter/sheath, inflating a balloon to manually expand the valve, mechanically expanding the valve, or a combination of these).

The deploying/releasing the docking station such that it expands to an expanded configuration and engages an interior surface of the vasculature, IVC, SVC, aorta, aortic valve, heart, circulatory system, etc. can comprise a partial deployment/release of the docking station such that a portion of the docking station remains in the catheter/sheath. A step of retrieving or recapturing the docking station (whether fully deployed or partially deployed) can be used and can involve retracting the docking station into the sheath/catheter or advancing the sheath/catheter over the docking station. If retrieved or recaptured, a step of repositioning the docking station catheter/sheath and the docking station to a second or different/modified location can be used, then the docking station can be fully deployed/released such that it expands to the expanded configuration and engages an interior surface of the vasculature, IVC, SVC, aorta, aortic valve, heart, circulatory system, etc.

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