Patent Description:
A wide variety of intracorporeal medical devices have been developed for medical use, for example, surgical and/or intravascular use. Some of these devices include guidewires, catheters, medical device delivery systems (e.g., for stents, grafts, replacement valves, etc.), and the like. These devices are manufactured by any one of a variety of different manufacturing methods and may be used according to any one of a variety of methods. Of the known medical devices and methods, each has certain advantages and disadvantages. There is an ongoing need to provide alternative medical devices as well as alternative methods for manufacturing and/or using medical devices.

<CIT> discloses a two-step heart valve implantation using a two-part heart valve implant.

The present invention is directed to a replacement heart valve system as set forth in the claims. According to the invention, the replacement heart valve system comprises an expandable docking station configured for implantation within a native heart valve, the expandable docking station including a plurality of sacrificial valve leaflets disposed within an anchoring element defining a lumen extending through the anchoring element; and a replacement heart valve implant configured to be disposed within the lumen of the expandable docking station, the replacement heart valve implant including a plurality of valve leaflets disposed within a tubular anchor member defining a lumen extending through the tubular anchor member.

In addition or alternatively, and in a second aspect, the plurality of sacrificial valve leaflets is configured to move between an open configuration permitting antegrade fluid flow through the expandable docking station and a closed configuration preventing retrograde fluid flow through the expandable docking station.

In addition or alternatively, and in a third aspect, the plurality of valve leaflets is configured to move between an open configuration permitting antegrade fluid flow through the replacement heart valve implant and a closed configuration preventing retrograde fluid flow through the replacement heart valve implant.

In addition or alternatively, and in a fourth aspect, the anchoring element is configured to shift between an elongated delivery configuration and a shortened, radially expanded deployed configuration.

In addition or alternatively, and in a fifth aspect, the anchoring element is configured to clamp native valve leaflets of the native heart valve in the deployed configuration.

In addition or alternatively, and in a sixth aspect, the anchoring element comprises an upstream flange, a downstream flange, and a central portion disposed between the upstream flange and the downstream flange.

In addition or alternatively, and in a seventh aspect, the upstream flange extends radially outward of the central portion in the deployed configuration.

In addition or alternatively, and in an eighth aspect, the downstream flange extends radially outward of the central portion in the deployed configuration.

In addition or alternatively, and in a ninth aspect, the expandable docking station includes a seal member disposed on at least a portion of an outer surface of the anchoring element.

In addition or alternatively, and in a tenth aspect, the seal member is disposed on the central portion of the anchoring element.

In addition or alternatively, and in an eleventh aspect, the tubular anchor member is configured to shift between an elongated delivery configuration and a shortened, radially expanded deployed configuration.

In addition or alternatively, and in a twelfth aspect, the tubular anchor member is configured to engage the anchoring element in the deployed configuration of the tubular anchor member.

In addition or alternatively, and in a thirteenth aspect, when the tubular anchor member is in the deployed configuration within the anchoring element, the plurality of sacrificial valve leaflets is compressed between the tubular anchor member and the anchoring element thereby forming a fluid tight seal therebetween.

In addition or alternatively, and in a fourteenth aspect, the expandable docking station includes a leaflet subframe disposed within the lumen of the anchoring element.

In addition or alternatively, and in a fifteenth aspect, a replacement heart valve system may comprise an expandable docking station configured for implantation within a native heart valve, the expandable docking station including a plurality of sacrificial valve leaflets disposed within a braided anchoring element defining a lumen extending through the braided anchoring element; a replacement heart valve implant configured to be disposed within the lumen of the expandable docking station, the replacement heart valve implant including a plurality of valve leaflets disposed within a tubular anchor member defining a lumen extending through the tubular anchor member; a docking station delivery device, wherein the expandable docking station is disposed within a lumen of the docking station delivery device in the delivery configuration for delivery to the native heart valve; and a replacement heart valve delivery device, wherein the replacement heart valve implant is disposed within a lumen of the replacement heart valve delivery device in the delivery configuration for delivery to the expandable docking station disposed within the native heart valve.

Also disclosed herein is a method of deploying a replacement heart valve implant within a native heart valve that may comprise advancing a docking station delivery device having an expandable docking station disposed within a lumen of the docking station delivery device in a delivery configuration to the native heart valve, wherein the expandable docking station includes a plurality of sacrificial valve leaflets disposed within an anchoring element defining a lumen extending through the anchoring element; deploying the expandable docking station from the docking station delivery device into the native heart valve and expanding the expandable docking station to a deployed configuration; and deploying a replacement heart valve implant within the lumen of the anchoring element, the replacement heart valve implant including a plurality of valve leaflets disposed within a tubular anchor member defining a lumen extending through the tubular anchor member.

In addition or alternatively, the method may further comprise advancing a replacement heart valve delivery device having the replacement heart valve implant disposed within a lumen of the replacement heart valve delivery device in a delivery configuration to the native heart valve, wherein deploying the replacement heart valve implant includes deploying the replacement heart valve implant from the replacement heart valve delivery device into the lumen of the anchoring element and expanding the replacement heart valve implant to a deployed configuration.

In addition or alternatively, in the deployed configuration, the tubular anchor member of the replacement heart valve implant is engaged with the anchoring element of the expandable docking station.

In addition or alternatively, deploying the replacement heart valve implant within the lumen of the anchoring element compresses the plurality of sacrificial valve leaflets between the tubular anchor member and the anchoring element thereby forming a fluid tight seal therebetween.

In addition or alternatively, the expandable docking station includes a seal member disposed on at least a portion of an outer surface of the anchoring element.

While aspects of the disclosure are amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit aspects of the disclosure to the particular embodiments described.

The following description should be read with reference to the drawings, which are not necessarily to scale, wherein like reference numerals indicate like elements throughout the several views. The detailed description and drawings are intended to illustrate but not limit the claimed invention. Those skilled in the art will recognize that the various elements described and/or shown may be arranged in various combinations and configurations without departing from the scope of the disclosure. The detailed description and drawings illustrate example embodiments of the claimed invention.

The term "extent" may be understood to mean a greatest measurement of a stated or identified dimension. For example, "outer extent" may be understood to mean a maximum outer dimension, "radial extent" may be understood to mean a maximum radial dimension, "longitudinal extent" may be understood to mean a maximum longitudinal dimension, etc. Each instance of an "extent" may be different (e.g., axial, longitudinal, lateral, radial, circumferential, etc.) and will be apparent to the skilled person from the context of the individual usage. Generally, an "extent" may be considered a greatest possible dimension measured according to the intended usage. In some instances, an "extent" may generally be measured orthogonally within a plane and/or cross-section, but may be, as will be apparent from the particular context, measured differently - such as, but not limited to, angularly, radially, circumferentially (e.g., along an arc), etc..

Diseases and/or medical conditions that impact the cardiovascular system are prevalent throughout the world. Some mammalian hearts (e.g., human, etc.) include four heart valves: a tricuspid valve <NUM>, a pulmonary valve <NUM>, an aortic valve <NUM>, and a mitral valve <NUM>, as seen in an example heart <NUM> illustrated in <FIG>. The purpose of the heart valves is to allow blood to flow through the heart <NUM> and from the heart <NUM> into the major blood vessels connected to the heart <NUM>, such as the aorta <NUM> and the pulmonary artery <NUM>, for example. In a normally functioning heart valve, blood is permitted to pass or flow downstream through the heart valve (e.g., from an atrium to a ventricle, from a ventricle to an artery, etc.) when the heart valve is open, and when the heart valve is closed, blood is prevented from passing or flowing back upstream through the heart valve (e.g., from a ventricle to an atrium, etc.). Some relatively common medical conditions may include or be the result of inefficiency, ineffectiveness, or complete failure of one or more of the valves within the heart. Treatment of defective heart valves poses other challenges in that the treatment often requires the repair or outright replacement of the defective valve. Such therapies may be highly invasive to the patient. Disclosed herein are medical devices that may be used within a portion of the cardiovascular system in order to diagnose, treat, and/or repair the system. At least some of the medical devices disclosed herein may include a replacement heart valve (e.g., a replacement aortic valve, a replacement mitral valve, etc.) and may reduce, treat, and/or prevent the occurrence of defects such as (but not limited to) regurgitation, leaflet prolapse, and/or valve stenosis. In addition, the devices disclosed herein may deliver the replacement heart valve percutaneously and, thus, may be much less invasive to the patient, although other surgical methods and approaches may also be used. The devices disclosed herein may also provide a number of additional desirable features and benefits as described in more detail below. For the purpose of this disclosure, the discussion below is directed toward a replacement mitral valve and will be so described in the interest of brevity. This, however, is not intended to be limiting as the skilled person will recognize that the following discussion may also apply to a replacement aortic valve or another replacement heart valve with no or minimal changes to the structure and/or scope of the disclosure.

An example replacement heart valve system may include a delivery sheath <NUM> (or multiple delivery sheaths <NUM>), such as those known and/or used with replacement heart valves, and one or more implants and/or medical devices <NUM> configured for implantation within an annulus of a native heart valve. For the purpose of this disclosure, reference numerals <NUM> and <NUM> may be considered generic placeholders that may be interchanged with other corresponding reference numerals used in the embodiment(s) described below. The specific corresponding features will be readily apparent to the skilled person. The replacement heart valve system may include the implants and/or medical devices <NUM> disposed within a lumen of the delivery sheath <NUM> proximate a distal end of the delivery sheath <NUM> in an elongated delivery configuration, as seen in <FIG> for example, the implants and/or medical devices <NUM> being expandable to a deployed configuration when unconstrained by the delivery sheath <NUM>. Further details regarding the replacement heart valve system, the delivery sheath(s) <NUM>, and/or the implants and/or medical devices <NUM> will be described below. <FIG> illustrates several possible approaches that may be used to deliver the replacement heart valve system and/or the implants and/or medical devices <NUM> to the mitral valve <NUM> with the delivery sheath(s) <NUM>.

In some embodiments, the implants and/or medical devices <NUM> may be delivered percutaneously to the mitral valve <NUM> via a transseptal approach "A". Within the transseptal approach "A", which involves transiting the septum of the heart <NUM>, the delivery sheath <NUM> may be advanced into right atrium of the heart <NUM> through the inferior vena cava ("A1") or the superior vena cava ("A2") before transiting the septum. In some embodiments, the implants and/or medical devices <NUM> may be delivered surgically to the mitral valve <NUM> via a left atriotomy "B", which involves surgically opening the left atrium of the heart <NUM>. In some embodiments, the implants and/or medical devices <NUM> may be delivered percutaneously to the mitral valve <NUM> via a transaortic approach "C", which involves transiting the aorta <NUM> (from a femoral entry point in some cases), the aortic arch, the aortic valve <NUM>, and the left ventricle of the heart <NUM>. In some embodiments, the implants and/or medical devices <NUM> may be delivered surgically to the mitral valve <NUM> via a transapical approach "D", which involves transiting the wall of the left ventricle of the heart <NUM>. Certain constructional details of the delivery sheath(s) <NUM> (e.g., length, stiffness, column strength, etc.) may be adjusted according to the approach used in any given procedure. Orientation of the implants and/or medical devices <NUM> within the delivery sheath(s) <NUM> may be adjusted depending upon the selected approach used in any given procedure. Some suitable but non-limiting materials for the delivery sheath(s) <NUM>, for example metallic materials, polymer materials, composite materials, etc., are described below.

<FIG> illustrates a docking station delivery device <NUM> including an expandable docking station <NUM> configured for implantation within a native heart valve (e.g., mitral valve <NUM>, aortic valve <NUM>, etc.), the expandable docking station <NUM> disposed within a lumen of the docking station delivery device <NUM> in a delivery configuration. In some embodiments, the docking station delivery device <NUM> may include a delivery sheath <NUM> having a lumen <NUM> extending from a proximal portion and/or proximal end of the delivery sheath <NUM> to a distal end of the delivery sheath <NUM>. In some embodiments, the docking station delivery device <NUM> may include a handle (not shown) disposed proximate the proximal end of the delivery sheath <NUM>. In one example, the expandable docking station <NUM> may be considered to correspond to an implant and/or medical device <NUM> above, and the delivery sheath <NUM> may be considered to correspond to a delivery sheath <NUM>. For the purpose of the disclosure and ease of understanding, the terms may be used interchangeably herein.

The docking station delivery device <NUM> may include an elongate shaft <NUM> disposed within the lumen <NUM> of the delivery sheath <NUM> and/or slidable with respect to the delivery sheath <NUM> within the lumen <NUM> of the delivery sheath <NUM>. In some embodiments, the elongate shaft <NUM> may be a tubular structure having a lumen extending therethrough, the elongate shaft <NUM> may be a solid shaft, or the elongate shaft <NUM> may be a combination thereof. In use, the elongate shaft <NUM> may be used to move the expandable docking station <NUM> with respect to the delivery sheath <NUM> of the docking station delivery device <NUM>. For example, the elongate shaft <NUM> may be advanced distally within the lumen <NUM> of the delivery sheath <NUM> to push the expandable docking station <NUM> out the distal end of the delivery sheath <NUM> and/or the docking station delivery device <NUM> to deploy the expandable docking station <NUM> in the native heart valve. Alternatively, the elongate shaft <NUM> may be held in a fixed position relative to the expandable docking station <NUM> and the delivery sheath <NUM> may be withdrawn proximally relative to the elongate shaft <NUM> and/or the expandable docking station <NUM> to deploy the expandable docking station <NUM> in the native heart valve. Some examples of suitable but non-limiting materials for the docking station delivery device <NUM>, the delivery sheath <NUM>, the elongate shaft <NUM>, and/or components or elements thereof, are described below.

In some embodiments, the expandable docking station <NUM> may include one or more suture loops attached thereto. In embodiments having more than one suture loop, the suture loops may be spaced apart around a circumference of the expandable docking station <NUM>. The one or more suture loops may be used in delivering the expandable docking station <NUM> to the native heart valve, and may extend through the delivery sheath <NUM> of the docking station delivery device <NUM> and/or may be attached to the elongate shaft <NUM> of the docking station delivery device <NUM>. The one or more suture loops may permit retrieval of the expandable docking station <NUM> during a deployment procedure, for example, if the expandable docking station <NUM> needs to be repositioned. In some embodiments, after deploying the expandable docking station <NUM> in the native heart valve, the one or more suture loops may remain attached thereto, thus permitting later retrieval of the expandable docking station <NUM>.

<FIG> illustrates some additional details of the expandable docking station <NUM>, shown in an elongated delivery configuration. According to the invention, the expandable docking station <NUM> includes a braided anchoring element <NUM> defining a lumen <NUM> extending through the braided anchoring element <NUM>. In some embodiments, the expandable docking station <NUM> and/or the braided anchoring element <NUM> may include a first end portion <NUM>, a central portion <NUM>, and a second end portion <NUM> disposed opposite the first end portion <NUM> relative to the central portion <NUM> and/or with the central portion <NUM> disposed between the first end portion <NUM> and the second end portion <NUM>. In at least some embodiments, the braided anchoring element <NUM> may comprise a self-expanding braided and/or woven mesh structure made up of one or more filaments disposed and/or interwoven circumferentially about the lumen <NUM> of the braided anchoring element <NUM> and/or the expandable docking station <NUM>. Non-self-expanding, mechanically-expandable, and/or assisted self-expanding braided anchoring elements are also contemplated. In at least some embodiments, the braided anchoring element <NUM> may be formed as a unitary structure (e.g., formed from a single filament or strand of wire, cut from a single tubular member, etc.). The first end portion <NUM> may form an upstream flange <NUM> in a shortened, radially expanded deployed configuration, the second end portion <NUM> may form a downstream flange <NUM> in the shortened, radially expanded deployed configuration (see <FIG> for example), and the central portion <NUM> may be disposed between the upstream flange <NUM> and the downstream flange <NUM>.

In some embodiments, the first end portion <NUM> and/or the second end portion <NUM> may have a relatively large pitch angle and/or spacing between adjacent windings of the one or more filaments. In one example, the first end portion <NUM> and/or the second end portion <NUM> may have a pitch angle of about <NUM> degrees. Other suitable pitch angles, including but not limited to, <NUM> degrees, <NUM> degrees, <NUM> degrees, etc. are also contemplated. The pitch angle and/or spacing between adjacent windings of the one or more filaments of the first end portion <NUM> and/or the second end portion <NUM> may provide a relatively low radially outward force allowing the first end portion <NUM> and/or the upstream flange <NUM>, and/or the second end portion <NUM> and/or the downstream flange <NUM>, to substantially conform to the native heart valve's anatomy, thereby aiding in sealing and mitigating leakage around the periphery of the expandable docking station <NUM> and/or the braided anchoring element <NUM>.

In some embodiments, the central portion <NUM> may have a relatively low pitch angle and/or spacing between adjacent windings of the one or more filaments. In one example, the central portion <NUM> may have a pitch angle of about <NUM> degrees. Other suitable pitch angles, including but not limited to, <NUM> degrees, <NUM> degrees, etc. are also contemplated. The pitch angle and/or spacing between adjacent windings of the one or more filaments of the central portion <NUM> may provide a relatively high radially outward force designed to form a substantially circular orifice configured to receive and/or accept a replacement heart valve implant (discussed below). The relatively high radially outward force may overcome the natural stiffness of the native tissue/anatomy and remodel the native valve opening into the substantially circular orifice to provide a consistent receptacle for seating the replacement heart valve implant, thereby potentially improving replacement heart valve implant leaflet function and durability.

In some embodiments, the braided anchoring element <NUM> may include a first transition zone <NUM> between the central portion <NUM> and the first end portion <NUM> having a relative pitch angle and/or spacing between adjacent windings of the one or more filaments intermediate to the pitch angle of the first end portion <NUM> and the pitch angle of the central portion <NUM>. For example, the first transition zone <NUM> may have a pitch angle of about <NUM> degrees, about <NUM> degrees, about <NUM> degrees, etc. Similarly, in some embodiments, the braided anchoring element <NUM> may include a second transition zone <NUM> between the central portion <NUM> and the second end portion <NUM> having a relative pitch angle and/or spacing between adjacent windings of the one or more filaments intermediate to the pitch angle of the second end portion <NUM> and the pitch angle of the central portion <NUM>. For example, the second transition zone <NUM> may have a pitch angle of about <NUM> degrees, about <NUM> degrees, about <NUM> degrees, etc..

In some embodiments, the varying pitch angle and/or spacing between adjacent windings of the one or more filaments along the axial and/or longitudinal length of the braided anchoring element <NUM> may permit the braided anchoring element <NUM> and/or the expandable docking station <NUM> to deploy out of the delivery sheath <NUM> and/or the docking station delivery device <NUM> with a varying speed and/or degree of spring rate. For example, the first end portion <NUM> and/or the second end portion <NUM>, having a relatively large pitch angle and/or spacing between adjacent windings of the one or more filaments, may form, recoil, and/or expand to the deployed configuration (shown in <FIG> for example) relatively slowly (e.g., with a low spring rate), while the central portion <NUM>, having a relatively low pitch angle and/or spacing between adjacent windings of the one or more filaments, may form, recoil, and/or expand to the deployed configuration relatively quickly (e.g., with a high spring rate). In some embodiments, the variable speed at which the braided anchoring element <NUM> and/or the expandable docking station <NUM> may be deployed allows for fast and more effective encapsulation, capture, and/or clamping of the native heart valve leaflets.

The expandable docking station <NUM> and/or the braided anchoring element <NUM> may be configured to shift between the elongated delivery configuration and the shortened, radially expanded deployed configuration. <FIG> illustrates the expandable docking station <NUM> and/or the braided anchoring element <NUM> in the shortened, radially expanded deployed configuration. As mentioned above, the first end portion <NUM> may form an upstream flange <NUM>, the second end portion <NUM> may form a downstream flange <NUM> and the central portion <NUM> may be disposed therebetween. An interior-facing surface of the braided anchoring element <NUM> may define the lumen <NUM> extending through the braided anchoring element <NUM>. In some embodiments, the upstream flange <NUM> may extend radially outward of the central portion <NUM> in the deployed configuration. In some embodiments, the downstream flange <NUM> may extend radially outward of the central portion <NUM> in the deployed configuration. In some embodiments, the braided anchoring element <NUM> may be configured to clamp native valve leaflets of the native heart valve between the upstream flange <NUM> and the downstream flange <NUM> in the deployed configuration, as seen in <FIG> for example.

In some embodiments, the expandable docking station <NUM> and/or the braided anchoring element <NUM> may include one or more barbs configured to attach the braided anchoring element <NUM> to the native heart valve and/or native valve leaflets. In some embodiments, the one or more barbs may extend from the upstream flange <NUM> and/or the downstream flange <NUM> in the deployed configuration. In some embodiments, the one or more barbs may extend from a radially outermost edge and/or extent of the upstream flange <NUM> and/or the downstream flange <NUM> in the deployed configuration. The one or more barbs may assist in preventing migration of the expandable docking station <NUM> and/or the braided anchoring element <NUM> relative to the native heart valve. Some examples of suitable but non-limiting materials for the barbs, the braided anchoring element <NUM>, and/or components or elements thereof, are described below.

In some embodiments, the expandable docking station <NUM> may include a seal member <NUM> disposed on and/or about at least a portion of an outer surface of the braided anchoring element <NUM>. In at least some embodiments, the seal member <NUM> may be disposed on and/or about the central portion <NUM> of the braided anchoring element <NUM>. In some embodiments, the seal member <NUM> may be coupled and/or secured to the braided anchoring element <NUM>. As seen in <FIG> for example, the seal member <NUM> may be sufficiently flexible and/or pliable to conform to and/or around native valve leaflets and/or the native heart valve in the deployed configuration, thereby sealing an exterior of the expandable docking station <NUM> within and/or against the native heart valve and/or the native valve leaflets and preventing leakage around the expandable docking station <NUM> and/or the braided anchoring element <NUM>.

In some embodiments, the seal member <NUM> may include a plurality of layers of polymeric material. Some suitable polymeric materials may include, but are not necessarily limited to, polycarbonate, polyurethane, polyamide, polyether block amide, polyethylene, polyethylene terephthalate, polypropylene, polyvinylchloride, polytetrafluoroethylene, polysulfone, and copolymers, blends, mixtures or combinations thereof. Other suitable polymeric materials are also contemplated, some of which are discussed below.

<FIG> illustrates the expandable docking station <NUM> in partial cross-section. As shown, the expandable docking station <NUM> includes a plurality of sacrificial valve leaflets <NUM> disposed within the braided anchoring element <NUM> and/or the lumen <NUM> extending through the braided anchoring element <NUM>. In some embodiments, the plurality of sacrificial valve leaflets <NUM> may be attached and/or coupled to the braided anchoring element <NUM>. In some embodiments, the plurality of sacrificial valve leaflets <NUM> may be attached and/or coupled to the braided anchoring element <NUM> using sutures, adhesives, or other suitable means. The plurality of sacrificial valve leaflets <NUM> may comprise two valve leaflets, three valve leaflets, four valve leaflets, or another suitable number of valve leaflets as desired. In some embodiments, the plurality of valve leaflets <NUM> may be configured to move between an open configuration (shown in phantom in <FIG>) permitting antegrade fluid flow through the expandable docking station <NUM>, the braided anchoring element <NUM>, and/or the lumen <NUM> extending through the braided anchoring element <NUM>, and a closed configuration preventing retrograde fluid flow through the expandable docking station <NUM>, the braided anchoring element <NUM>, and/or the lumen <NUM> extending through the braided anchoring element <NUM>. The plurality of sacrificial valve leaflets <NUM> may each have a free edge, wherein the free edges of the plurality of sacrificial valve leaflets <NUM> coapt within the expandable docking station <NUM>, the braided anchoring element <NUM>, and/or the lumen <NUM> extending through the braided anchoring element <NUM> in the closed configuration. The plurality of sacrificial valve leaflets <NUM> may provide temporary heart valve function during a period of time between deployment of the expandable docking station <NUM> and deployment of a replacement heart valve implant therein, as will be described below. The plurality of sacrificial valve leaflets <NUM> may prevent regurgitation through the lumen <NUM> extending through the braided anchoring element <NUM>. Some examples of suitable but non-limiting materials for the plurality of sacrificial valve leaflets <NUM> are described below.

In some embodiments, the expandable docking station <NUM> may comprise the braided anchoring element <NUM> as an outer frame, and a leaflet subframe <NUM> having the plurality of sacrificial valve leaflets <NUM> attached thereto, the leaflet subframe <NUM> being disposed within the expandable docking station <NUM>, the braided anchoring element <NUM>, and/or the lumen <NUM> extending through the braided anchoring element <NUM>, as shown in <FIG> for example. The leaflet subframe <NUM> may include a wire <NUM> formed into a plurality of commissures corresponding to the plurality of sacrificial valve leaflets <NUM>. For example, for each sacrificial valve leaflet there may be one commissure formed in the leaflet subframe <NUM>. Each of the plurality of sacrificial valve leaflets <NUM> may be attached to two adjacent commissures of the leaflet subframe <NUM>, resulting in two adjacent sacrificial valve leaflets <NUM> each being attached to the same commissure and/or each other at the same commissure. The plurality of sacrificial valve leaflets <NUM> may each have a free edge, wherein the free edges of the plurality of sacrificial valve leaflets <NUM> coapt within the leaflet subframe <NUM> in the closed configuration. The leaflet subframe <NUM> may be attached to the braided anchoring element <NUM> at a plurality of locations, using sutures for example. In some embodiments, the leaflet subframe <NUM> may be attached to the braided anchoring element <NUM> along the wire <NUM> between adjacent commissures. In one non-limiting example, the leaflet subframe <NUM> may be attached to the braided anchoring element <NUM> at three discrete locations, approximately <NUM> degrees apart for example, thereby permitting relative movement between the braided anchoring element <NUM> and the leaflet subframe <NUM> for easily collapsing the expandable docking station <NUM> to the elongated delivery configuration. Other orientations and/or configurations are also contemplated, including but not limited to attachment at more or less than three discrete locations and/or varied spacing of the discrete locations. Some examples of suitable but non-limiting materials for the leaflet subframe <NUM> are described below.

<FIG> illustrates a replacement heart valve delivery device <NUM> including a replacement heart valve implant <NUM> configured to be disposed within the lumen <NUM> of the expandable docking station <NUM> within a native heart valve (e.g., mitral valve <NUM>, aortic valve <NUM>, etc.), wherein the replacement heart valve implant <NUM> is disposed within a lumen of the replacement heart valve delivery device <NUM> in a delivery configuration for delivery to the lumen <NUM> extending through the braided anchoring element <NUM> of the expandable docking station <NUM> disposed within the native heart valve in the deployed configuration. In some embodiments, the replacement heart valve delivery device <NUM> may include a delivery sheath <NUM> having a lumen extending from a proximal portion and/or proximal end of the delivery sheath <NUM> to a distal end of the delivery sheath <NUM>. In some embodiments, the replacement heart valve delivery device <NUM> may include a handle <NUM> disposed proximate the proximal end of the delivery sheath <NUM>. In one example, the replacement heart valve implant <NUM> may be considered to correspond to an implant and/or medical device <NUM> above, and the delivery sheath <NUM> may be considered to correspond to a delivery sheath <NUM>. For the purpose of the disclosure and ease of understanding, the terms may be used interchangeably herein.

The replacement heart valve delivery device <NUM> may include an elongate shaft <NUM> disposed within the lumen of the delivery sheath <NUM> and/or slidable with respect to the delivery sheath <NUM> within the lumen of the delivery sheath <NUM>. In some embodiments, the elongate shaft <NUM> may be a tubular structure having a lumen extending therethrough, the elongate shaft <NUM> may be a solid shaft, or the elongate shaft <NUM> may be a combination thereof. In use, the elongate shaft <NUM> may be used to move the replacement heart valve implant <NUM> with respect to the delivery sheath <NUM> of the replacement heart valve delivery device <NUM>. For example, the elongate shaft <NUM> may be advanced distally within the lumen of the delivery sheath <NUM> to push the replacement heart valve implant <NUM> out the distal end of the delivery sheath <NUM> and/or the replacement heart valve delivery device <NUM> to deploy the replacement heart valve implant <NUM> within the lumen <NUM> of the expandable docking station <NUM> in the native heart valve. Alternatively, the elongate shaft <NUM> may be held in a fixed position relative to the replacement heart valve implant <NUM> and the delivery sheath <NUM> may be withdrawn proximally relative to the elongate shaft <NUM> and/or the replacement heart valve implant <NUM> to deploy the replacement heart valve implant <NUM> within the lumen <NUM> of the expandable docking station <NUM> in the native heart valve. Deployment of the replacement heart valve implant <NUM> into and/or within the lumen <NUM> of the expandable docking station <NUM> may be seen in <FIG> and <FIG>. Some examples of suitable but non-limiting materials for the replacement heart valve delivery device <NUM>, the delivery sheath <NUM>, the elongate shaft <NUM>, and/or components or elements thereof, are described below.

Some additional details of an example replacement heart valve implant <NUM> may be seen in <FIG>. According to the invention, the replacement heart valve implant <NUM> includes a plurality of valve leaflets <NUM> disposed within a tubular anchor member <NUM> defining a lumen extending through the tubular anchor member <NUM>. The plurality of valve leaflets <NUM> may be attached and/or coupled to the tubular anchor member <NUM> at a plurality of locations. In some embodiments, the plurality of valve leaflets <NUM> may be attached and/or coupled to the tubular anchor member <NUM> using sutures, adhesives, or other suitable means. In some embodiments, the plurality of valve leaflets <NUM> may include two leaflets, three leaflets, four leaflets, etc. as desired. The plurality of valve leaflets <NUM> may each have a free edge, wherein the free edges of the plurality of valve leaflets <NUM> coapt within the replacement heart valve implant <NUM>, the tubular anchor member <NUM>, and/or the lumen extending through the tubular anchor member <NUM> in the closed configuration. The plurality of valve leaflets <NUM> of the replacement heart valve implant <NUM> may be configured to move between an open configuration permitting antegrade fluid flow through the replacement heart valve implant <NUM> and/or the lumen of the tubular anchor member <NUM> and a closed configuration preventing retrograde fluid flow through the replacement heart valve implant <NUM> and/or the lumen of the tubular anchor member <NUM>.

The replacement heart valve implant <NUM> and/or the tubular anchor member <NUM> may be configured to shift between an elongated delivery configuration (e.g., <FIG> and <FIG>) and a shortened, radially expanded deployed configuration (e.g., <FIG>). In some embodiments, the tubular anchor member <NUM> may comprise a self-expanding braided and/or woven mesh structure made up of one or more filaments disposed and/or interwoven circumferentially about the lumen of the tubular anchor member <NUM> and/or the replacement heart valve implant <NUM>. Non-self-expanding, mechanically-expandable, and/or assisted self-expanding tubular anchor members are also contemplated. In at least some embodiments, the tubular anchor member <NUM> may be formed as a unitary structure (e.g., formed from a single filament or strand of wire, cut from a single tubular member, etc.). Some examples of suitable but non-limiting materials for replacement heart valve implant <NUM>, the tubular anchor member <NUM>, and/or components or elements thereof, are described below.

An outer surface of the tubular anchor member <NUM> may be configured to engage an interior-facing surface of the braided anchoring element <NUM> in the deployed configuration of the tubular anchor member <NUM>. When the tubular anchor member <NUM> is in the deployed configuration within the braided anchoring element <NUM> of the expandable docking station <NUM>, the plurality of sacrificial valve leaflets <NUM> may be compressed, pinched, squeezed, etc. between at least a portion of the outer surface of the tubular anchor member <NUM> and at least a portion of the interior-facing surface of the braided anchoring element <NUM>, thereby forming a fluid tight seal therebetween. In some embodiments, the replacement heart valve implant <NUM> may additionally and/or optionally include a sealing member disposed around and/or on an outer surface of the tubular anchor member <NUM>. In at least some embodiments, the sealing member may be similar in form, construction, and/or function to the seal member <NUM> discussed above. Other configurations are also contemplated.

A replacement heart valve system according to the disclosure includes the expandable docking station <NUM> configured for implantation within a native heart valve, the expandable docking station <NUM> including the plurality of sacrificial valve leaflets <NUM> disposed within the braided anchoring element <NUM> defining the lumen <NUM> extending through the braided anchoring element <NUM>. A replacement heart valve system according to the disclosure includes the replacement heart valve implant <NUM> configured to be disposed within the lumen <NUM> of the expandable docking station <NUM>, the replacement heart valve implant <NUM> including the plurality of valve leaflets <NUM> disposed within the tubular anchor member <NUM> defining the lumen extending through the tubular anchor member <NUM>. A replacement heart valve system according to the disclosure may include the docking station delivery device <NUM>, wherein the expandable docking station <NUM> is disposed within the lumen <NUM> of the docking station delivery device <NUM> and/or the delivery sheath <NUM> in the delivery configuration for delivery to a native heart valve. A replacement heart valve system according to the disclosure may include the replacement heart valve delivery device <NUM>, wherein the replacement heart valve implant <NUM> is disposed within the lumen of the replacement heart valve delivery device <NUM> and/or the delivery sheath <NUM> in the delivery configuration for delivery to the expandable docking station <NUM> disposed within the native heart valve in the deployed configuration.

A method of deploying a replacement heart valve implant <NUM> within a native heart valve (e.g., aortic valve <NUM>, mitral valve <NUM>, etc.) may comprise advancing the docking station delivery device <NUM> having the expandable docking station <NUM> disposed within the lumen <NUM> of the docking station delivery device <NUM> and/or the delivery sheath <NUM> in the delivery configuration to the native heart valve, wherein the expandable docking station <NUM> includes the plurality of sacrificial valve leaflets <NUM> disposed within the braided anchoring element <NUM> defining the lumen <NUM> extending through the braided anchoring element <NUM>. The method may comprise deploying the expandable docking station <NUM> from the docking station delivery device <NUM> and/or the lumen <NUM> of the delivery sheath <NUM> into the native heart valve and expanding the expandable docking station <NUM> to the deployed configuration. In some embodiments, deploying the expandable docking station <NUM> may include clamping native valve leaflets of the native heart valve between the upstream flange <NUM> and the downstream flange <NUM> of the braided anchoring element <NUM>.

The method of deploying the replacement heart valve implant <NUM> may include advancing the replacement heart valve delivery device <NUM> having the replacement heart valve implant <NUM> disposed within the lumen of the replacement heart valve delivery device <NUM> and/or the delivery sheath <NUM> in the delivery configuration to the native heart valve and/or the expandable docking station <NUM>. The method of deploying the replacement heart valve implant <NUM> may include deploying the replacement heart valve implant <NUM> from replacement heart valve delivery device <NUM> into and/or within the lumen <NUM> of the braided anchoring element <NUM> and expanding the replacement heart valve implant <NUM> and/or the tubular anchor member <NUM> to the deployed configuration. In some embodiments, deploying the replacement heart valve implant <NUM> within the lumen <NUM> of the braided anchoring element <NUM> and/or expandable docking station <NUM> compresses the plurality of sacrificial valve leaflets <NUM> between an outer surface of the tubular anchor member <NUM> and an interior surface of the braided anchoring element <NUM>, thereby forming the fluid tight seal therebetween.

In some embodiments, the expandable docking station <NUM> and the replacement heart valve implant <NUM> may be delivered to the native heart valve using a single delivery device or delivery sheath, (e.g., the same delivery device and/or delivery sheath). In some embodiments, the implants and/or medical devices may be delivered and/or placed in a method involving multiple delivery devices and a single access point or multiple access points into the patient, depending on the approach used. Other configuration, arrangements, and/or methods are also contemplated.

The materials that can be used for the various components of the replacement heart valve system, the delivery sheath(s) <NUM>, and/or the implants and/or medical devices <NUM>, the docking station delivery device <NUM>, the expandable docking station <NUM>, the replacement heart valve delivery device <NUM>, the replacement heart valve implant <NUM>, etc. (and/or other systems or components disclosed herein) and the various elements thereof disclosed herein may include those commonly associated with medical devices. For simplicity purposes, the following discussion makes reference to the replacement heart valve system, the docking station delivery device <NUM>, the expandable docking station <NUM>, the replacement heart valve delivery device <NUM>, the replacement heart valve implant <NUM>, etc. However, this is not intended to limit the devices and methods described herein, as the discussion may be applied to other elements, members, components, or devices disclosed herein, such as, but not limited to, the delivery sheath(s) <NUM>/<NUM>, the elongate shaft(s) <NUM>/<NUM>, the braided anchoring element <NUM>, the tubular anchor member <NUM>, etc. and/or elements or components thereof.

In some embodiments, the replacement heart valve system, the docking station delivery device <NUM>, the expandable docking station <NUM>, the replacement heart valve delivery device <NUM>, the replacement heart valve implant <NUM>, etc., and/or components thereof may be made from a metal, metal alloy, polymer (some examples of which are disclosed below), a metal-polymer composite, ceramics, combinations thereof, and the like, or other suitable material. Some examples of suitable metals and metal alloys include stainless steel, such as 444V, <NUM>, and 314LV stainless steel; mild steel; nickel-titanium alloy such as linear-elastic and/or super-elastic nitinol; other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625 such as INCONEL® <NUM>, UNS: N06022 such as HASTELLOY® C-<NUM>®, UNS: N10276 such as HASTELLOY® C276®, other HASTELLOY® alloys, and the like), nickel-copper alloys (e.g., UNS: N04400 such as MONEL® <NUM>, NICKEL VAC® <NUM>, NICORROS® <NUM>, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R44035 such as MP35-N® and the like), nickel-molybdenum alloys (e.g., UNS: N10665 such as HASTELLOY® ALLOY B2®), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, and the like; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R44003 such as ELGILOY®, PHYNOX®, and the like); platinum enriched stainless steel; titanium; combinations thereof; and the like; or any other suitable material.

In at least some embodiments, portions or all of the replacement heart valve system, the docking station delivery device <NUM>, the expandable docking station <NUM>, the replacement heart valve delivery device <NUM>, the replacement heart valve implant <NUM>, etc., and/or components thereof, may also be doped with, made of, or otherwise include a radiopaque material. Radiopaque materials are understood to be materials capable of producing a relatively bright image on a fluoroscopy screen or another imaging technique during a medical procedure. This relatively bright image aids a user in determining the location of the replacement heart valve system, the docking station delivery device <NUM>, the expandable docking station <NUM>, the replacement heart valve delivery device <NUM>, the replacement heart valve implant <NUM>, etc. Some examples of radiopaque materials can include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloy, polymer material loaded with a radiopaque filler, and the like. Additionally, other radiopaque marker bands and/or coils may also be incorporated into the design of the replacement heart valve system, the docking station delivery device <NUM>, the expandable docking station <NUM>, the replacement heart valve delivery device <NUM>, the replacement heart valve implant <NUM>, etc. to achieve the same result.

In some embodiments, a degree of Magnetic Resonance Imaging (MRI) compatibility is imparted into the replacement heart valve system, the docking station delivery device <NUM>, the expandable docking station <NUM>, the replacement heart valve delivery device <NUM>, the replacement heart valve implant <NUM>, etc. For example, the replacement heart valve system, the docking station delivery device <NUM>, the expandable docking station <NUM>, the replacement heart valve delivery device <NUM>, the replacement heart valve implant <NUM>, etc., and/or components or portions thereof, may be made of a material that does not substantially distort the image and create substantial artifacts (e.g., gaps in the image). Certain ferromagnetic materials, for example, may not be suitable because they may create artifacts in an MRI image. The replacement heart valve system, the docking station delivery device <NUM>, the expandable docking station <NUM>, the replacement heart valve delivery device <NUM>, the replacement heart valve implant <NUM>, etc., or portions thereof, may also be made from a material that the MRI machine can image. Some materials that exhibit these characteristics include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R44003 such as ELGILOY®, PHYNOX®, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R44035 such as MP35-N® and the like), nitinol, and the like, and others.

In some embodiments, the replacement heart valve system, the docking station delivery device <NUM>, the expandable docking station <NUM>, the plurality of sacrificial valve leaflets <NUM>, the replacement heart valve delivery device <NUM>, the replacement heart valve implant <NUM>, the plurality of valve leaflets <NUM>, etc., and/or portions thereof, may be made from or include a polymer or other suitable material. Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, for example, DELRIN® available from DuPont), polyether block ester, polyurethane (for example, Polyurethane 85A), polypropylene (PP), polyvinylchloride (PVC), polyether-ester (for example, ARNITEL® available from DSM Engineering Plastics), ether or ester based copolymers (for example, butylene/poly(alkylene ether) phthalate and/or other polyester elastomers such as HYTREL® available from DuPont), polyamide (for example, DURETHAN® available from Bayer or CRISTAMID® available from Elf Atochem), elastomeric polyamides, block polyamide/ethers, polyether block amide (PEBA, for example available under the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA), silicones, polyethylene (PE), Marlex high-density polyethylene, Marlex low-density polyethylene, linear low density polyethylene (for example REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly paraphenylene terephthalamide (for example, KEVLAR®), polysulfone, nylon, nylon-<NUM> (such as GRILAMID® available from EMS American Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (for example, SIBS and/or SIBS 50A), polycarbonates, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers thereof, polymer/metal composites, and the like. In some embodiments the sheath can be blended with a liquid crystal polymer (LCP). For example, the mixture can contain up to about <NUM> percent LCP.

In some embodiments, the replacement heart valve system, the docking station delivery device <NUM>, the expandable docking station <NUM>, the replacement heart valve delivery device <NUM>, the replacement heart valve implant <NUM>, etc. may include and/or be formed from a textile material. Some examples of suitable textile materials may include synthetic yarns that may be flat, shaped, twisted, textured, pre-shrunk or un-shrunk. Synthetic biocompatible yarns suitable for use in the present invention include, but are not limited to, polyesters, including polyethylene terephthalate (PET) polyesters, polypropylenes, polyethylenes, polyurethanes, polyolefins, polyvinyls, polymethylacetates, polyamides, naphthalene dicarboxylene derivatives, natural silk, and polytetrafluoroethylenes. Moreover, at least one of the synthetic yarns may be a metallic yarn or a glass or ceramic yarn or fiber. Useful metallic yarns include those yarns made from or containing stainless steel, platinum, gold, titanium, tantalum or a Ni-Co-Cr-based alloy. The yarns may further include carbon, glass or ceramic fibers. Desirably, the yarns are made from thermoplastic materials including, but not limited to, polyesters, polypropylenes, polyethylenes, polyurethanes, polynaphthalenes, polytetrafluoroethylenes, and the like. The yarns may be of the multifilament, monofilament, or spun-types. The type and denier of the yarn chosen may be selected in a manner which forms a biocompatible and implantable prosthesis and, more particularly, a vascular structure having desirable properties.

In some embodiments, the replacement heart valve system, the docking station delivery device <NUM>, the expandable docking station <NUM>, the replacement heart valve delivery device <NUM>, the replacement heart valve implant <NUM>, etc. may include and/or be treated with a suitable therapeutic agent. Some examples of suitable therapeutic agents may include anti-thrombogenic agents (such as heparin, heparin derivatives, urokinase, and PPack (dextrophenylalanine proline arginine chloromethylketone)); anti-proliferative agents (such as enoxaparin, angiopeptin, monoclonal antibodies capable of blocking smooth muscle cell proliferation, hirudin, and acetylsalicylic acid); anti-inflammatory agents (such as dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, and mesalamine); antineoplastic/antiproliferative/anti-mitotic agents (such as paclitaxel, <NUM>-fluorouracil, cisplatin, vinblastine, vincristine, epothilones, endostatin, angiostatin and thymidine kinase inhibitors); anesthetic agents (such as lidocaine, bupivacaine, and ropivacaine); anti-coagulants (such as D-Phe-Pro-Arg chloromethyl keton, an RGD peptide-containing compound, heparin, anti-thrombin compounds, platelet receptor antagonists, anti-thrombin antibodies, anti-platelet receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors, and tick antiplatelet peptides); vascular cell growth promoters (such as growth factor inhibitors, growth factor receptor antagonists, transcriptional activators, and translational promoters); vascular cell growth inhibitors (such as growth factor inhibitors, growth factor receptor antagonists, transcriptional repressors, translational repressors, replication inhibitors, inhibitory antibodies, antibodies directed against growth factors, bifunctional molecules consisting of a growth factor and a cytotoxin, bifunctional molecules consisting of an antibody and a cytotoxin); cholesterol-lowering agents; vasodilating agents; and agents which interfere with endogenous vascoactive mechanisms.

Claim 1:
A replacement heart valve system, comprising:
an expandable docking station (<NUM>) configured for implantation within a native heart valve (<NUM>, <NUM>, <NUM>, <NUM>), the expandable docking station (<NUM>) including a plurality of sacrificial valve leaflets (<NUM>) disposed within an anchoring element (<NUM>) defining a lumen (<NUM>) extending through the braided anchoring element (<NUM>); and
a replacement heart valve implant (<NUM>) configured to be disposed within the lumen (<NUM>) of the expandable docking station (<NUM>), the replacement heart valve implant (<NUM>) including a plurality of valve leaflets (<NUM>) disposed within a tubular anchor member (<NUM>) defining a lumen extending through the tubular anchor member (<NUM>).