Patent Description:
The present disclosure concerns embodiments of a delivery system for implantation of a prosthetic valve, such as a prosthetic pulmonary valve.

The human heart can suffer from various valvular diseases. These valvular diseases can result in significant malfunctioning of the heart and ultimately require repair of the native valve or replacement of the native valve with an artificial valve. There are a number of known repair devices (e.g., stents) and artificial valves, as well as a number of known methods of implanting these devices and valves in humans. Percutaneous and minimally-invasive surgical approaches are used in various procedures to deliver prosthetic medical devices to locations inside the body that are not readily accessible by surgery or where access without surgery is desirable. In one specific example, a prosthetic heart valve can be mounted in a crimped state on the distal end of a delivery device and advanced through the patient's vasculature (e.g., through a femoral artery and the aorta) until the prosthetic valve reaches the implantation site in the heart. The prosthetic valve is then expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted, actuating a mechanical actuator that applies an expansion force to the prosthetic valve, or by deploying the prosthetic valve from a sheath of the delivery device so that the prosthetic valve can self-expand to its functional size.

Transcatheter heart valves may be appropriately sized to be placed inside most native aortic valves. However, with larger native valves, blood vessels, and grafts, aortic transcatheter valves might be too small to secure into the larger implantation or deployment site. In this case, the transcatheter valve may not be large enough to sufficiently expand inside the native valve or other implantation or deployment site to be secured in place.

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

One example approach to overcome such challenge is to use a docking device, or docking station, which is configured to be pre-implanted in the target implantation site, and then the prosthetic valve can be deployed within the docking device. The docking device can be configured to compensate for the deployed prosthetic valve being smaller than the annular space in which it is to be placed. However, conventional delivery systems for aortic valve implantation may not be convenient for delivering and implanting a prosthetic valve at the native pulmonary valve. Accordingly, improvements to the transcatheter delivery apparatus are desirable.

<CIT> discloses methods and apparatus for delivering prosthetic segments to a body lumen, which utilize a delivery device having an elongated flexible member including proximal and distal ends, a plurality of prosthetic segments arranged near the distal end and axially along the elongated flexible member and an outer sheath slidably disposed over at least a portion of the prosthetic segments. The delivery device also includes a control mechanism coupled with the outer sheath and the elongated flexible member, wherein the control mechanism is adapted to retract the sheath a fixed distance, the fixed distance selectable by an operator to expose a selected number of prosthetic segments and create a spacing between a proximal prosthetic segment in the selected number and a distal prosthetic segment remaining with the elongated flexible member.

Further, <CIT> refers to systems and methods for delivering prosthetic devices, such as prosthetic heart valves, through the body and into the heart for implantation therein. The prosthetic devices delivered with the delivery systems disclosed in this citation are radially expandable from a radially compressed state mounted on the delivery system to a radially expanded state for implantation using an inflatable balloon of the delivery system.

Moreover, <CIT> discloses a delivery system which is provided for a self-expanding medical device. The delivery system has a handle assembly with a housing. The housing has a slot with a deployment knob extending therethrough. The self-expanding medical device is deployed by restraining the housing of the handle assembly and pulling on the deployment knob. This causes an outer sheath to withdraw proximally from an inner catheter to release the self-expanding medical device from a space between the outer sheath and inner catheter.

The present disclosure is directed toward apparatuses relating to transvascular implantation of a prosthetic valve, such as a prosthetic pulmonary valve.

Certain embodiments of the disclosure concern delivery apparatus for implanting a prosthetic valve. The delivery apparatus as defined in claim <NUM> includes a handle, a first shaft extending from a distal end of the handle, a second shaft extending through a lumen of the first shaft and the handle, and a gripper located proximal to a proximal end of the handle. A proximal end of the second shaft is connected to the gripper, and the gripper is axially moveable relative to the handle such that axial movement of the gripper causes corresponding axial movement of the second shaft relative to the first shaft. The gripper has a bottom surface that is substantially coplanar with a bottom surface of the handle.

A distance from a longitudinal axis of second shaft to a bottom surface of the gripper can be substantially identical to a distance from a longitudinal axis of the first shaft to a bottom surface of the handle.

The handle can include a locking mechanism.

The locking mechanism can include a locker body having a user-engageable portion. The locker body can be moveable between a locked position and an unlocked position. When the locker body is in the unlocked position, the second shaft can be axially moveable relative to the handle and the first shaft. When the locker body is in the unlocked position, the second shaft cannot be axially movable relative to the first shaft and the handle.

The delivery apparatus can further include at least one detent element positioned to engage the user-engageable portion when the locker body is in the locked position or the unlocked position.

The locking mechanism can include a rotatable locker body having internal threads and a collet at least partially received within the locker body. The collet can include external threads engaging the internal threads of the locker body and be coaxially disposed around the second shaft. Rotation of the locker body can produce axial movement of the collet relative to the locker body and the second shaft. The locker body can be rotatable between a locked position and an unlocked position. When the locker body is in the unlocked position, the second shaft can be axially moveable relative to the handle, the first shaft, and the collet, and when the locker body is in the unlocked position, the collet can prevent axial movement of the second shaft relative to the first shaft and the handle.

The collet can have a distal opening through which a fourth shaft or hypotube extends, the fourth shaft comprises a flared portion, wherein the flared portion has a diameter that is larger than a diameter of the distal opening such that proximal movement of a fourth shaft is blocked when the flared portion abuts the collet.

The handle can have a chamber and a stopper disposed inside the chamber, wherein the second shaft extends through the handle and an opening on the stopper. The second shaft can include a flared portion. The flared portion can have a diameter that is larger than a diameter of the opening on the stopper such that proximal movement of the second shaft is blocked when the flared portion abuts the stopper.

A method for implanting a prosthetic valve which is not covered by the claims, can include inserting the delivery apparatus into a vasculature of a patient. The prosthetic valve can be crimped over a non-inflated balloon coupled to a distal end portion of the second shaft, and the prosthetic valve can be covered by a valve sheath connected to a distal end portion of the first shaft. The proximal end of the second shaft can be connected to the gripper located proximal to the proximal end of the handle. A distance from an axial axis of second shaft to a bottom surface of the gripper can be substantially identical to a distance from an axial axis of the first shaft to a bottom surface of the handle.

An assembly can include a radially expandable and compressible prosthetic valve, and the delivery apparatus. The prosthetic valve can be mounted over an inflatable balloon coupled to a distal end portion of the second shaft. The handle can include a locking mechanism. The locking mechanism can include a locker body having a user-engageable portion. The locker body can be moveable between a locked position and an unlocked position. When the locker body is in the unlocked position, the gripper can be axially moveable relative to the handle, and when the locker body is in the unlocked position, the gripper cannot be axially movable relative to the handle. The user-engagement portion can be configured to engage at least one detent element when the locker body is in the locked position or unlocked position.

The foregoing and other objects, features, and advantages of the disclosed technology will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.

<FIG> shows perspective view of a prosthetic heart valve <NUM>, according to one embodiment. The illustrated valve can be adapted to be implanted in the native pulmonary valve annulus, although in other embodiments it can be adapted to be implanted in the other native annuluses of the heart, such as the native aortic annulus. The valve <NUM> can have four main components: a stent, or frame, <NUM>, a valvular structure <NUM>, an inner skirt <NUM>, and an outer skirt <NUM>.

The valvular structure <NUM> can comprise three leaflets <NUM>, collectively forming a leaflet structure (although a greater or fewer number of leaflets can be used), which can be arranged to collapse in a tricuspid arrangement. The leaflets <NUM> are configured to permit the flow of blood from an inflow end <NUM> to an outflow end <NUM> of the prosthetic valve <NUM> and block the flow of blood from the outflow end <NUM> to the inflow end <NUM> of the prosthetic valve <NUM>. The leaflets <NUM> can be secured to one another at their adjacent sides to form commissures <NUM> of the leaflet structure. The lower edge of leaflet structure <NUM> desirably has an undulating, curved scalloped shape. By forming the leaflets with this scalloped geometry, stresses on the leaflets can be reduced, which in turn can improve durability of the valve. Moreover, by virtue of the scalloped shape, folds and ripples at the belly of each leaflet (the central region of each leaflet), which can cause early calcification in those areas, can be eliminated or at least minimized. The scalloped geometry can also reduce the amount of tissue material used to form leaflet structure, thereby allowing a smaller, more even crimped profile at the inflow end of the valve. The leaflets <NUM> can be formed of pericardial tissue (e.g., bovine pericardial tissue), biocompatible synthetic materials, or various other suitable natural or synthetic materials as known in the art and described in <CIT>.

The frame <NUM> can be formed with a plurality of circumferentially spaced slots, or commissure windows <NUM> (three in the illustrated embodiment) that are adapted to mount the commissures <NUM> of the valvular structure <NUM> to the frame. The frame <NUM> can be made of any of various suitable plastically-expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., Nitinol) as known in the art. When constructed of a plastically-expandable material, the frame <NUM> (and thus the valve <NUM>) can be crimped to a radially compressed state on a delivery apparatus and then expanded inside a patient by an inflatable balloon or equivalent expansion mechanism. When constructed of a self-expandable material, the frame <NUM> (and thus the valve <NUM>) can be crimped to a radially compressed state and restrained in the compressed state by insertion into a sheath or equivalent mechanism of a delivery apparatus. Once inside the body, the valve can be advanced from the delivery sheath, which allows the valve to expand to its functional size.

Suitable plastically-expandable materials that can be used to form the frame <NUM> include, without limitation, stainless steel, a nickel based alloy (e.g., a cobalt-chromium or a nickel-cobalt-chromium alloy), polymers, or combinations thereof. In particular embodiments, frame <NUM> is made of a nickel-cobalt-chromium-molybdenum alloy, such as MP35N™ (tradename of SPS Technologies), which is equivalent to UNS R30035 (covered by ASTM F562-<NUM>). MP35N™/UNS R30035 comprises <NUM>% nickel, <NUM>% cobalt, <NUM>% chromium, and <NUM>% molybdenum, by weight. It has been found that the use of MP35N to form frame <NUM> can provide superior structural results over stainless steel. In particular, when MP35N is used as the frame material, less material is needed to achieve the same or better performance in radial and crush force resistance, fatigue resistances, and corrosion resistance. Moreover, since less material is required, the crimped profile of the frame can be reduced, thereby providing a lower profile valve assembly for percutaneous delivery to the treatment location in the body.

The inner skirt <NUM> can be secured to the inside of frame <NUM> via sutures. In some embodiments, valvular structure <NUM> can be attached to the inner skirt <NUM> via one or more thin polyethylene terephthalate (PET) reinforcing strips, which enables a secure suturing and protects the pericardial tissue of the leaflet structure from tears. The inner skirt <NUM> can assist in securing the valvular structure <NUM> to the frame <NUM> and to assist in forming a good seal between the valve and the native annulus by blocking the flow of blood through the open cells of the frame <NUM> below the lower edge of the leaflets. The inner skirt <NUM> desirably comprises a tough, tear resistant material such as PET, although various other synthetic or natural materials can be used. The thickness of the inner skirt desirably is less than <NUM> (<NUM> mil), and desirably less than <NUM> (<NUM> mil), and even more desirably about <NUM> (<NUM> mil). In particular embodiments, the inner skirt <NUM> can have a variable thickness, for example, the skirt can be thicker at its edges than at its center. In one implementation, the inner skirt <NUM> can comprise a PET skirt having a thickness of about <NUM> at its edges and about <NUM> at its center. The thinner inner skirt can provide for better crimping performances while still providing good perivalvular sealing.

The outer skirt <NUM> can be laser cut or otherwise formed from a strong, durable piece of material, such as woven PET, although other synthetic or natural materials can be used. The outer skirt <NUM> can be secured to the outside of the frame <NUM> via sutures. The outer skirt <NUM> can be so configured that when the frame is in its expanded state, there is excess material or slack between the skirt's lower and upper edges that does not lie flat against the outer surface of the frame <NUM>. The slack between the lower and upper edges of the outer skirt <NUM> allows the frame <NUM> to elongate axially when crimped without any resistance from the outer skirt. Also, when the valve <NUM> is deployed within the body, the excess material of the outer skirt <NUM> can fill in gaps between the frame <NUM> and the surrounding native annulus to assist in forming a good fluid-tight seal between the valve and the native annulus. When implanted in an outer docking stent (as described below), the outer skirt <NUM> can seal against the inner surface of the docking stent. The outer skirt <NUM> therefore can cooperate with the inner skirt <NUM> to avoid perivalvular leakage after implantation of the valve <NUM>.

Further details of the valve <NUM> and its components are described in <CIT>.

<FIG> show a delivery apparatus <NUM>, which can be used to implant a prosthetic valve (such as the prosthetic valve <NUM>) at a target implantation side of a patient, such as the native pulmonary annulus, according to one embodiment. In particular embodiments, the delivery apparatus <NUM> can be used to implant a prosthetic valve within a docking stent implanted in the native pulmonary annulus or the pulmonary artery, as described in detail below.

As shown, the delivery apparatus <NUM> includes a handle <NUM>, a first shaft <NUM> (which is an outer shaft in the illustrated embodiment) extending from a distal end of the handle <NUM>, and a second shaft <NUM> (which is an intermediate shaft in the illustrated embodiment) extending through a lumen of the first shaft <NUM> and the handle <NUM>. The second shaft can also be referred to as a "balloon shaft" because an inflatable balloon is mounted on a distal end portion of the second shaft, as described in further detail below. The delivery apparatus <NUM> can also include a third shaft <NUM> (which is an inner shaft in the illustrated embodiment) extending through a lumen of the second shaft <NUM>. A distal end of the third shaft <NUM> can be connected to a nosecone <NUM>, which can have a tapered distal end portion for atraumatic navigation through the patient's vasculature. In some embodiments, a guidewire (not shown) can extend through a lumen of the third shaft <NUM> and the nosecone <NUM> so that the delivery apparatus <NUM> can navigate through the patient's vasculature over the previously inserted guidewire.

As shown, the delivery apparatus <NUM> includes a gripper <NUM> located proximal to a proximal end <NUM> of the handle <NUM>. As described more fully below, a proximal end of the balloon shaft <NUM> is connected to the gripper <NUM> such that axial movement of the gripper <NUM> relative to the handle <NUM> causes corresponding axial movement of the balloon shaft <NUM> relative to the outer shaft <NUM> (and the handle <NUM>). Similarly, a proximal end of the inner shaft <NUM> can also be connected to the gripper <NUM> such that axial movement of the of the gripper <NUM> relative to the handle <NUM> can cause corresponding axial movement of the inner shaft <NUM> relative to the outer shaft <NUM> (and the handle). Thus, in the illustrated embodiment, axial movement of the gripper <NUM> relative to the handle <NUM> moves the inner shaft <NUM> and the balloon shaft <NUM> together relative to the handle <NUM> and the outer shaft <NUM>.

As shown in <FIG> and <FIG>, a distal end portion of the delivery apparatus <NUM> can have a balloon shoulder assembly <NUM> configured to mount an inflatable balloon thereto as described below. The balloon shoulder assembly <NUM> includes a proximal shoulder <NUM> connected to a distal end portion of the balloon shaft <NUM> and a distal shoulder <NUM> connected to a distal end portion of the inner shaft <NUM>. The proximal shoulder <NUM> and the distal shoulder <NUM> are spaced apart from one another, in an axial direction relative to a central longitudinal axis of the delivery apparatus <NUM>.

In some embodiments, the proximal shoulder <NUM> can be affixed to the distal end portion of the balloon shaft <NUM> using any known means, such as by welding, an adhesive, mechanical fasteners, etc. Likewise, the distal shoulder <NUM> can be affixed to the distal end portion of the inner shaft <NUM> using any known means, such as by welding, an adhesive, mechanical fasteners, etc..

The distal shoulder <NUM> can have a distal leg portion 124d and a proximal flared portion 124p that has a larger diameter than the distal leg portion 124d (see, e.g., <FIG>). Similarly, the proximal shoulder <NUM> can have a proximal leg portion and a distal flared portion that has a larger diameter than the proximal leg portion.

In certain examples, the distal leg portion 124d and the proximal flared portion 124p of the distal shoulder <NUM> can be formed as a unitary piece molded from a thermoplastic elastomers, such as Pebax. The distal shoulder <NUM> can have a durometer ranging from about 35D to about 75D. In one particular example, the distal shoulder <NUM> has a durometer of about 55D. Similarly, the proximal leg portion and the distal flared portion of the proximal shoulder <NUM> can be formed as a unitary piece molded from the same or similar materials as the distal shoulder <NUM>. In other examples, the distal leg portion 124d and the proximal flared portion 124p of the distal shoulder <NUM> (and/or the proximal leg portion and the distal flared portion of the proximal shoulder <NUM>) can be initially formed as separated pieces and then bonded together.

In some embodiments, the nosecone <NUM> and the distal shoulder <NUM> can be a one-piece or unitary component, that is, the nosecone <NUM> is a distal portion of the unitary component and the distal shoulder <NUM> is a proximal portion of the unitary component. In other embodiments, the nosecone <NUM> and the distal shoulder <NUM> can be separate components, and each can be mounted on the inner shaft <NUM> next to each other or at axially spaced locations.

<FIG> further depict the nosecone <NUM>, according to certain examples. As shown, the nosecone <NUM> can have a body portion <NUM> and an interface portion <NUM> extending proximally from the body portion <NUM>. The body portion <NUM> can have a tapered shape with a progressively decreasing diameter from a proximal end portion 101p of the body portion <NUM> to a distal tip portion 101d of the body portion <NUM>. The body portion <NUM>, including its distal tip portion 101d, can comprise a flexible material so that the distal tip portion 101d can flex during insertion of the delivery apparatus and/or tracking of the patient's vasculature in the implantation procedure.

The proximal end portion 101p of the body portion <NUM> can have an engagement end <NUM> configured to engage with a distal end of a valve sheath (e.g., <NUM>), as described further below. The outer diameter at the engagement end <NUM> can define the largest outer diameter of the nosecone <NUM>. As shown in <FIG>, the interface portion <NUM> can have a generally cylindrical shape and have an outer diameter that is smaller than the outer diameter at the engagement end <NUM>. Thus, there can be a step decrease of diameter from the proximal end of the body portion <NUM> to the interface portion <NUM>, forming a vertical wall <NUM> that is substantially perpendicular to the central longitudinal axis of the delivery apparatus <NUM>. In other examples, the interface portion <NUM> can have a partially spherical shape.

As described below, a valve sheath (e.g., <NUM>) can be in a covered position (see, e.g., <FIG>) to cover a radially compressed prosthetic valve (e.g., <NUM>) folded around the balloon shoulder assembly <NUM>. In the covered position, the engagement end <NUM> of the nosecone <NUM> can abut a distal end of the valve sheath. As a result, when the distal tip portion 101d of the nosecone <NUM> flexes during the insertion and/or tracking procedures, the distal end of the valve sheath can remain contact with the vertical wall <NUM> of the nosecone <NUM> (i.e., preventing axial separation and/or gap between the engagement end <NUM> of the nosecone <NUM> and the distal end of the valve sheath).

In some examples, the outer diameter of the interface portion <NUM> can be about the same as or slightly smaller than an inner diameter of a valve sheath so that a distal end portion of the valve sheath can frictionally engage an outer surface of the interface portion <NUM>. In addition, the outer diameter at the engagement end <NUM> can be about the same as an outer diameter of the valve sheath. In other words, the height of the vertical wall <NUM> (i.e., the difference between the outer diameter at the engagement end <NUM> and the outer diameter of the interface portion <NUM>) can be about the same as the thickness of the valve sheath (i.e., the difference between the outer diameter and inner diameter of the valve sheath). Thus, when the valve sheath is in the covered position, the outer surface of the valve sheath and the outer surface of the body portion <NUM> of the nosecone <NUM> can form a continuous smooth surface (i.e., no step increase or decrease of outer diameter).

As depicted in <FIG>, the nosecone <NUM> can have an inner lumen <NUM> configured to receive a guidewire <NUM> and a proximal recess <NUM> configured to receive the distal leg portion 124d of the distal shoulder <NUM>. <FIG> shows an exploded view of the nosecone <NUM> and the distal shoulder <NUM>. The diameter of the proximal recess <NUM> can be larger than the diameter of the inner lumen <NUM>. The proximal recess <NUM> can extend from a proximal end of the interface portion <NUM> into the body portion <NUM>. The inner lumen <NUM> can extend from a distal end of the proximal recess <NUM> to a distal end of the body portion <NUM>. During assembly, the distal leg portion 124d can be inserted into the recess <NUM>. The distal leg portion 124d can be bonded to the nosecone <NUM>, such as with induction welding, an adhesive, etc. The nosecone <NUM> can be made of the same material as the distal shoulder <NUM>. In some examples, the nosecone <NUM> and the distal shoulder <NUM> are made of Pebax, such as Pebax having a durometer of about <NUM> D.

<FIG> show a cross-sectional view of the balloon shoulder assembly <NUM> and an inflatable balloon <NUM> folded around the proximal and distal shoulders. The balloon <NUM> has a proximal end portion <NUM> surrounding and/or folded over the proximal shoulder <NUM> and a distal end portion <NUM> surrounding and/or folded over the distal shoulder <NUM>. The balloon <NUM> also has a valveretaining portion <NUM> between the proximal end portion <NUM> and the distal end portion <NUM>, surrounding and/or folded in the space that separates the proximal shoulder <NUM> and the distal shoulder <NUM> (e.g., between flared ends of the proximal shoulder <NUM> and the distal shoulder <NUM>).

As illustrated in <FIG>, the prosthetic heart valve <NUM> can be crimped onto the valve retaining portion <NUM> of the balloon <NUM> between the proximal and distal shoulders, which prevent or reduce axial movement of the prosthetic valve <NUM> relative to the balloon <NUM> during insertion of the delivery apparatus <NUM> into the patient's vasculature and delivery of the prosthetic valve <NUM> to the target implantation site.

As shown in <FIG>, the outer diameter of the inner shaft <NUM> can be sized such that an annular space <NUM> is defined between the inner shaft <NUM> and the balloon shaft <NUM> along the entire length of the balloon shaft <NUM>. The annular space <NUM> can be fluidly coupled to one or more fluid passageways of the delivery apparatus <NUM> which can be fluidly connectable to a fluid source (e.g., a syringe) that can inject an inflation fluid (e.g., saline) into the delivery apparatus. In this way, fluid from the fluid source can flow through the one or more fluid passageways, through the annular space <NUM>, and into the balloon <NUM> to inflate the balloon <NUM> and expand and deploy the prosthetic valve <NUM>. <FIG> illustrates the flow of fluid (indicated by arrows <NUM>) through the annular space <NUM> and through passages in the proximal shoulder <NUM> and distal shoulder <NUM>. The fluid can then flow into the balloon <NUM> to expand the valve <NUM>.

In some embodiments, a radiopaque marker <NUM> can be placed between the proximal shoulder <NUM> and the distal shoulder <NUM>. For example, the radiopaque marker <NUM> can be placed on the outer surface of the inner shaft <NUM> and aligned with the center of the valve retaining portion <NUM> of the balloon <NUM>. As described below, the radiopaque marker <NUM> can be used for aligning the prosthetic valve <NUM> with the native valve under fluoroscopy during an implantation procedure. The radiopaque marker <NUM> can be optional. For example, in certain embodiments, no radiopaque marker is placed between the proximal shoulder <NUM> and the distal shoulder <NUM>.

Further details regarding the balloon shoulder assembly, methods of mounting the folding the balloon onto the balloon shoulder assembly, and methods of crimping a prosthetic valve onto the valve retaining portion of the balloon are disclosed in <CIT>, <CIT>, <CIT>, <CIT>, and <CIT>.

As shown in <FIG>, the delivery apparatus <NUM> can further include a valve sheath <NUM> (also referred to as a delivery capsule) which is configured to cover the prosthetic valve <NUM> mounted on the balloon <NUM> in a radially compressed state. In the depicted embodiment, a proximal end 138p of the valve sheath <NUM> is connected to a distal end 104d of the outer shaft <NUM>. In some embodiments, the proximal end 138p of the valve sheath <NUM> can be fixedly coupled to the distal end 104d of the outer shaft <NUM> by any known means, such as welding, an adhesive, etc..

As noted above, both the balloon shaft <NUM> and the inner shaft <NUM> can be axially moveable relative to the outer shaft <NUM>. Thus, the valve sheath <NUM>, which is connected to the outer shaft <NUM>, is axially moveable relative to the proximal shoulder <NUM> connected to the balloon shaft <NUM> and the distal shoulder connected to the inner shaft <NUM>. Specifically, the valve sheath <NUM> is moveable between a covered position, as shown in <FIG>, and an uncovered position, as shown in <FIG>.

When the valve sheath <NUM> is in the covered position (<FIG>), the engagement end <NUM> of the nosecone <NUM> can abut a distal end 138d of the valve sheath <NUM>. The length (L) of the valve sheath <NUM> is configured to be slightly longer than the entire length of the balloon shoulder assembly <NUM> (measured from the proximal end of the proximal shoulder <NUM> to the distal end of the distal shoulder <NUM>). Thus, when the valve sheath <NUM> is in the covered position, the balloon <NUM> folded around the balloon shoulder assembly <NUM> can be completely covered by the valve sheath <NUM>. Further, the inner diameter of the valve sheath <NUM> is configured to be slightly larger than the radial diameter of the prosthetic valve <NUM> when it is crimped onto the valve retaining portion <NUM> of the balloon <NUM>. Thus, when the valve sheath <NUM> is in the covered position, the radially compressed prosthetic valve <NUM> can be retained inside the valve sheath <NUM>. As described below, the prosthetic valve <NUM> is retained inside the valve sheath <NUM> when navigating through the patient's vasculature (e.g., through the tricuspid cordae). Thus, the sheath <NUM> serves to protect the inside of the patient's vasculature against contact with the outer surface of the prosthetic valve <NUM> as the delivery apparatus and the prosthetic valve are inserted into and advanced through the patient's vasculature to the implantation site.

In the depicted embodiment, the outer diameter of the valve sheath <NUM> is larger than the outer diameter of the outer shaft <NUM>. For example, the outer diameter of the valve sheath <NUM> can range between about <NUM> to about <NUM> in some examples, more desirably between about <NUM> and <NUM> in some examples, and even more desirably between about <NUM> and <NUM> in some examples (e.g., <NUM>). The outer diameter of the outer shaft <NUM> can range between about <NUM> to about <NUM> in some examples, more desirably between about <NUM> and <NUM> in some examples, and even more desirably between about <NUM> and <NUM> in some examples (e.g., <NUM>). In other embodiments, the outer diameter of the valve sheath <NUM> can be about the same as the outer diameter of the outer shaft <NUM>.

As shown in <FIG>, the outer diameter of the valve sheath <NUM> can be about the same as the outer diameter at the engagement end <NUM> of the nosecone <NUM>. Thus, when the valve sheath <NUM> is in the covered position, the outer surface of the valve sheath <NUM> and the outer surface of the nosecone <NUM> can form a continuous smooth surface, tapering from the valve sheath <NUM> to the distal end of the nosecone <NUM>. In some embodiments, the outer surfaces of both the valve sheath <NUM> and the nosecone <NUM> are coated with a hydrophilic material to facilitate navigation through the patient's vasculature.

When the valve sheath <NUM> is in the uncovered position (<FIG>), the distal end 138d of the valve sheath <NUM> is moved to a position that is proximal to the proximal shoulder <NUM>. Thus, the balloon <NUM> mounted between the shoulders <NUM>, <NUM> can be exposed (note that the balloon is omitted from <FIG> to illustrate the underlying shoulders). Further, if the prosthetic valve <NUM> is crimped onto the valve retaining portion <NUM> of the balloon <NUM>, then the prosthetic valve <NUM> can be exposed when the valve sheath <NUM> is in the uncovered position, as illustrated in <FIG>. In one particular embodiment, when the valve sheath <NUM> is in the uncovered position (<FIG>), the axial distance (D1) between the distal end 138d of the valve sheath <NUM> and the engagement end <NUM> of the nosecone <NUM> is about the same as the axial length (L) of the valve sheath <NUM>. In other embodiments, the length (L) can be larger than the distance (D1).

In some embodiments, when the valve sheath <NUM> is in the covered position (<FIG>), the axial distance (D2) between the proximal end <NUM> of the handle <NUM> and a distal end 112d of the gripper <NUM> is about the same as the distance (D <NUM>). Thus, when the distance (D <NUM>) is about the same as the axial length (L) of the valve sheath <NUM>, the distance (D2) is about the same as length (L). Accordingly, if the prosthetic valve <NUM> is originally retained within the valve sheath <NUM>, by axially moving the handle <NUM> relative to the gripper <NUM> until the proximal end <NUM> of the handle <NUM> abuts the distal end 112d of the gripper <NUM>, the valve sheath <NUM> is moved to the uncovered position and the prosthetic valve <NUM> can be exposed.

In some embodiments, the outer shaft <NUM> can comprise multiple sections of varying flexibility along its length. For example, the outer shaft <NUM> can have a proximal section 105a, an intermediate section 105b, and a distal section 105c. The proximal section can have a higher durometer than the intermediate section, and the intermediate section can have a higher durometer than the distal section. In one specific embodiment, the proximal section 105a has a durometer of 72D, the intermediate section 105b has a durometer of 55D, and the distal section 105c has a durometer of 35D. Thus, the higher flexibility of the distal section makes it easier to advance through tortuous vasculature, and the stiffer intermediate and proximal sections allows for improved steering capability and pushability of the delivery apparatus <NUM>. In other embodiments, the outer shaft <NUM> can comprise any number of sections (e.g., <NUM>, <NUM>, <NUM>, <NUM>, etc.) with varying durometers along its length.

In some embodiments, the outer shaft <NUM> (and/or the valve sheath <NUM>) can be constructed using a multi-layer structure to yield desired elasticity and/or rigidity at different sections along its length. For example, <FIG> illustrates a tube <NUM> (which can be a part of the outer shaft <NUM> and/or the valve sheath <NUM>) having a multi-layer structure, according to one embodiment. In this example, the tube <NUM> includes an inner liner <NUM>, an optional tie layer <NUM> extending over the inner liner <NUM>, an optional helical coil member <NUM> wrapped around the tie layer <NUM> and the inner liner <NUM>, a braided layer <NUM> covering the coil member <NUM>, and a heat shrink layer <NUM> extending over an end of the coil member <NUM> for the purpose of retention, and an outer layer <NUM> covering the braided layer <NUM>. The inner liner <NUM>, braided layer <NUM> and outer layer <NUM> can extend the full length of the outer shaft <NUM> and the valve sheath <NUM>, with the valve sheath <NUM> having a larger outer diameter than the outer shaft <NUM>. In some embodiments, the coil member <NUM> can extend from the distal end of the valve sheath 138d to the proximal end 138p. The heat shrink layer <NUM> can cover a small section of coil member <NUM> at the distal and proximal ends 138d, 138p to retain the coil member <NUM>. In certain embodiments, the tie layer <NUM> can extend from the distal end of the valve sheath <NUM> to a proximal end of the distal section 105c of the outer shaft <NUM>.

In certain embodiments, the inner liner <NUM> can be made of polytetrafluoroethylene (PTFE), and the tie layer <NUM> and the outer layer <NUM> can be made of thermoplastic elastomers, such as Pebax. By applying heat to the heat shrink layer <NUM> (e.g., a PET material), the heat shrink layer can shrink and apply inward pressure to the coil member <NUM>. Such inward pressure can help retaining coil member <NUM> at the distal and proximal ends 138d, 138p. In certain embodiments, the multi-layered shaft <NUM> can be covered with a disposable heat shrink layer (e.g., fluorinated ethylene propylene, or FEP) and heat can be applied to the entire shaft. The heated outer layer <NUM> flow into the braided layer <NUM> and the coil layer <NUM> to bind those layers together. The multi-layered shaft can then be cooled, after which the disposable heat shrink layer (e.g., FEP) can be removed. By incorporating the helical coil member <NUM>, a section of the tube <NUM> can be configured to have higher hoop strength and greater anti-kinking ability. On the other hand, a section of the tube <NUM> can be configured to be more flexible by removing the coil member <NUM> utilizing outer layers (e.g., Pebax® thermoplastic elastomers) of different durometers. The braided layer <NUM> also enhances the kink resistance of the shaft. In some embodiments, the braided layer <NUM> can be configured to have reduced weave density or may be completely removed to further improve the flexibility of the section of the tube <NUM>.

As shown in <FIG> and <FIG>, the delivery apparatus <NUM> has an integrated inline introducer <NUM> comprising a sheath <NUM> and a flush port member <NUM> (also referred to as a hub) connected to a proximal end of the sheath <NUM>. The outer shaft <NUM> can be configured to extend through an inner lumen of the sheath <NUM> and the flush portion member <NUM>. The flush port member <NUM> can house one or more seals through which the outer shaft <NUM> extends. The one or more seals can establish a fluid seal against the outer surface of the outer shaft <NUM>. In addition, the delivery apparatus <NUM> can include a dilator <NUM> (<FIG>), which has a tapered tip and is configured to dilate a surgical opening in a blood vessel (e.g., a femoral vein) to facilitate insertion of the distal end portion of the delivery apparatus and the introducer into the blood vessel.

The flush portion member <NUM> can have a flush port <NUM> through which a fluid, such as saline, may be injected into the introducer so as to flush the inner lumen of the sheath <NUM> and the outer surface of the outer shaft <NUM>. As best shown in <FIG>, the outer diameter of the delivery sheath <NUM> can be greater than the outer diameter of the sheath <NUM>. In some examples, the outer diameter of the sheath <NUM> can range between about <NUM> to about <NUM> in some examples, more desirably between about <NUM> and <NUM> in some examples, and even more desirably between about <NUM> and <NUM> in some examples (e.g., <NUM>).

Further, the outer shaft <NUM> and the valve sheath <NUM> connected thereto are configured to be axially movable relative to the sheath <NUM> and the flush port member <NUM>. For example, <FIG> show that the outer shaft <NUM> is advanced distally relative to the sheath <NUM> such that the proximal end 138p of the valve sheath <NUM> is separated from a distal end 116d of the sheath <NUM>. On the other hand, <FIG> shows that the outer shaft <NUM> can be moved to a position where the proximal end 138p of the valve sheath <NUM> abuts the distal end 116d of the sheath <NUM>.

<FIG> show the handle <NUM>, the gripper <NUM>, and their respective components, according to one embodiment. As described above and indicated by the double-sided arrow <NUM>, the handle <NUM> and the gripper <NUM> are axially moveably relative to each other. Further, the handle <NUM> can include a locking mechanism <NUM> which can selectively lock and permit axial movement of the handle <NUM> relative to the gripper <NUM>. For example, the locking mechanism <NUM> can include a locker body <NUM> that is moveable between a locked position (L) and an unlocked position (U) as indicated by arrow <NUM>. As best shown in <FIG>, the locked position and the unlocked position can be respectively marked on the handle with visual indicators to an operator of the handle. As described more fully below, the locking mechanism <NUM> can be configured such that when the locker body <NUM> is in the unlocked position, the gripper <NUM> and the shafts connected thereto (e.g., the balloon shaft <NUM> and the inner shaft <NUM>) are axially moveable relative to the handle <NUM> and the outer shaft <NUM>. On the other hand, when the locker body <NUM> is in the locked position, the gripper <NUM> and the shafts connected thereto (e.g., the balloon shaft <NUM> and the inner shaft <NUM>) are not axially moveable relative to the handle <NUM> and the outer shaft <NUM>.

As best shown in <FIG>, the gripper <NUM> has a bottom surface 112b that is coplanar or substantially coplanar with a bottom surface 102b of the handle <NUM>, according to one example embodiment. The coplanar design of the surfaces 102b and 112b is advantageous in that it can facilitate linear movement of the handle <NUM> relative to the gripper <NUM>. For example, in use, a physician can place the handle <NUM> and the gripper <NUM> on a surface, such as on an operating table or on the patient's thigh. If the bottom surfaces 102b and 112b are at different heights, then the shaft section extending between the handle <NUM> and the gripper <NUM> (the proximal portions of the balloon shaft <NUM> and the inner shaft <NUM>) can bend. This in turn can increase friction between the shaft section and the proximal opening of the handle, which can make moving the handle and the gripper relative to each other in an axial direction (proximally and distally) more difficult. By virtue of the surfaces 102b and 112b being coplanar or substantially coplanar, deflection of the shaft section between the handle and gripper is prevented or minimized when placed on a working surface (e.g., an operating table or the patient's thigh), which reduces the manual pushing and pulling forces required to move these components relative to each other (proximally and distally) and improves control over unsheathing the prosthetic valve <NUM>.

According to one embodiment, the bottom surfaces 112b and 102b are deemed substantially coplanar when a vertical distance (H1) from a central longitudinal axis 106a of the balloon shaft <NUM> to the bottom surface 112b of the gripper <NUM> is substantially identical to a vertical distance (H2) from a central longitudinal axis 104a of the outer shaft <NUM> to the bottom surface 102b of the handle <NUM>. The distances (H1) and (H2) are deemed substantially identical if the difference between (H1) and (H2) is less than <NUM>% of (H2) in certain examples, even more desirably less than <NUM>% of (H2) in certain examples. In a particular embodiment, the central longitudinal axis 106a of the balloon shaft <NUM> coincides with the central longitudinal axis 104a of the outer shaft <NUM> (i.e., the shafts <NUM> and <NUM> are coaxial).

The substantial identical heights (H1) and (H2) can ensure that the balloon shaft <NUM> and the outer shaft <NUM> remain substantially coaxial when the handle <NUM> and the gripper <NUM> are placed on a working surface and these components are moved axially relative to each other. Otherwise, if (H1) is substantially different from (H2), the shaft section between the handle and gripper can bend, which can increase sliding friction between the shafts and increasing resistance to the axial movement.

<FIG> is an exploded view of some components of the handle <NUM> and the gripper <NUM>, according to one embodiment. As shown, the handle <NUM> has a housing <NUM>, which can include two half shells 154a, 154b, each of which can have about a generally semi-cylindrical shape. The shell 154a can have longitudinal edges that are configured to matingly engage respective longitudinal edges of the shell 154b to form a clam shell configuration. The housing <NUM> can define a lumen <NUM> through which the balloon shaft <NUM> extends.

As shown, the handle <NUM> can have a hub <NUM> disposed within a distal end portion of the lumen <NUM>. A proximal end 104p of the outer shaft <NUM> can be fixedly coupled to a distal end of the hub <NUM>. The balloon shaft <NUM> can extend through a lumen of the hub <NUM> and the lumen of the outer shaft <NUM>. An O-ring (not shown) can be placed on the balloon shaft <NUM> at the proximal end of the hub <NUM> or within the hub to seal any gaps between the outer surface of the balloon shaft <NUM> and the lumen of the hub <NUM>. A one-way valve <NUM> can be fluidly connected to the lumen of hub <NUM>. The one-way valve <NUM> can have a port <NUM> extending outside the housing <NUM> through an opening on one of the half shells (see <FIG>). Thus, through the port <NUM>, a flushing fluid can be injected through the valve <NUM> into the lumen of the hub <NUM> and further into the lumen of the outer shaft <NUM>, thereby flushing the outer surface of the balloon shaft <NUM>.

The locker body <NUM> of the locking mechanism <NUM> can be disposed within a proximal end portion of the lumen <NUM> of the handle <NUM>. The locker body <NUM> can include a cylindrical portion <NUM> and a user-engageable tab <NUM> extending radially outwardly from the cylindrical portion <NUM>. The tab <NUM> can extend into and is rotationally moveable within a recessed or cutout region <NUM> located at the proximal end portion of the handle <NUM> (see <FIG>).

The locking mechanism <NUM> can further include a collet <NUM> that is at least partially received within a lumen <NUM> of the locker body <NUM>. For example, in the embodiment depicted in <FIG>, the collet <NUM> includes a star-shaped end plate <NUM> having a plurality of radial projections <NUM>, a neck portion <NUM> extending proximally from the end plate <NUM>, and a plurality of cantilevered arms <NUM> (two are shown in the depicted example) extending proximally from the neck portion <NUM>. As shown in <FIG>, the arms <NUM> and neck portion <NUM> of the collet <NUM> can be disposed within the lumen <NUM> of the locker body <NUM>. The lumen <NUM> has a proximal portion 178p and a distal portion 178d. The lumen <NUM> has a tapered shape such that the proximal portion 178p has a smaller diameter than the distal portion 178d. Each of the projections <NUM> can abut corresponding interior surface portions of the handle, which allow the collet <NUM> to slide axially within the handle but prevent rotational movement of the collet relative to the handle.

The delivery apparatus <NUM> can further include another or fourth shaft, such as the illustrated hypotube <NUM>, which can be made of a metal or alloy material and desirably is more rigid and has a higher kink resistance than the balloon shaft <NUM>. As shown in <FIG>, the hypotube <NUM> can surround at least a proximal portion of the balloon shaft <NUM> and extend through the collet <NUM> and the locker body <NUM>. A proximal end of the hypotube <NUM> can be connected to the gripper <NUM>. Specifically, the hypotube <NUM> can extend through an opening <NUM> in the end plate <NUM> and a lumen of the neck portion <NUM>, such that the plurality of arms <NUM> of the collet <NUM> can be coaxially disposed around the hypotube <NUM>.

The inner surface of the locker body, which defines the lumen <NUM>, can have a plurality of inner threads <NUM>. The neck portion <NUM> of the collet <NUM> can have corresponding outer threads <NUM> that are configured to threadably engage the inner threads <NUM> of the locker body <NUM>. According to one embodiment, rotating the locker body <NUM> around its central axis can cause corresponding axial movement of the collet <NUM> relative to the locker body <NUM> and the hypotube <NUM>. Movement of the collet <NUM> can be caused by the threads <NUM>, <NUM> engaging each other and by the radial projections <NUM> of the end plate <NUM> which engage corresponding inner surfaces of the shells <NUM> so as to prevent rotational movement of the collet <NUM> but allow it to slide axially. For example, rotating the locker body <NUM> in a first direction (e.g., toward the locked position) can cause the collet <NUM> to move in a proximal direction, whereas rotating the locker body <NUM> in a second direction opposite the first direction (e.g., toward the unlocked position) can cause the collet <NUM> to move in a distal direction.

According to one embodiment, when the locker body <NUM> is in the locked position (L), distal end portions of the arms <NUM> are advanced into the narrower proximal portion 178p of the locker lumen <NUM>. As a result, the arms <NUM> can be resiliently compressed radially inwardly so as to clasp or clamp against the hypotube <NUM>. Because the proximal end of the hypotube <NUM> is connected to the gripper <NUM>, clamping the hypotube <NUM> can prevent axial movement between the handle <NUM> and the gripper <NUM>. When the locker body <NUM> is in the unlocked position (U), the distal end portions of the arms <NUM> are moved into the wider distal portion 178d of the locker lumen <NUM>. As a result, the resiliently compressed arms <NUM> can expand radially outwardly, thus releasing their grasp on the hypotube <NUM>, thereby allowing axial movement of the hypotube relative to the collet and axial movement between the gripper <NUM> and the handle <NUM>.

As shown in <FIG>, the hypotube <NUM> can have a flared distal end portion <NUM> which has an enlarged diameter relative to the remaining portion of the hypotube. The diameter of the flared portion <NUM> can be larger than a diameter of the opening <NUM> in the end plate <NUM> of the collet <NUM>. Thus, when moving the gripper <NUM> away from the handle <NUM> in the proximal direction (and when the locker body <NUM> is in the unlocked position), the movement of the gripper <NUM> is prevented when the flared portion <NUM> abuts the end plate <NUM> of the collet <NUM>, as best shown in <FIG>. In this manner, the end plate <NUM> can serve as a hard stop for the hypotube <NUM> to prevent excessive movement of the gripper <NUM> relative to the handle <NUM> in the proximal direction.

In the depicted embodiment, the flared portion <NUM> is located at a distal end of the hypotube <NUM>. In other embodiments, the flared portion <NUM> can be located at a position that is proximal to the distal end (e.g., at the middle section) of the hypotube <NUM>. The distance between the flared portion <NUM> and the gripper <NUM> is selected to determine how far the gripper <NUM> can be moved axially away from the handle <NUM> in the proximal direction. In one particular embodiment, the distance between the flared portion <NUM> and the gripper <NUM> is equal to or greater than the axial distance (D1) between the distal end 138d of the valve sheath <NUM> and the engagement end <NUM> of the nosecone <NUM> when the valve sheath <NUM> is in the uncovered position (see e.g., <FIG>). In a specific implementation, the distance between the flared portion <NUM> and the gripper <NUM> is about equal to the sum of the distance between the end plate <NUM> and the proximal end <NUM> of the handle <NUM> and the axial distance (D1) between the distal end 138d of the valve sheath <NUM> and the engagement end <NUM> of the nosecone <NUM> when the valve sheath <NUM> is in the uncovered position (see e.g., <FIG>).

In certain examples, the middle section of the hypotube <NUM> can have a visually perceivable marker band <NUM> (see <FIG>). In certain examples, the marker band <NUM> can be laser edged on the hypotube <NUM>. In certain examples, the marker band <NUM> can be painted over the hypotube <NUM>. In certain examples, the marker band <NUM> can be taped and/or glued on the hypotube <NUM>.

The marker band <NUM> can be so positioned on the hypotube <NUM> that the appearance of the marker band <NUM> in the gap between the gripper <NUM> and the handle <NUM> indicates fully capture or resheathing of the balloon <NUM>, as described further below. In other words, when the gripper <NUM> contacts or is in close proximity to the handle <NUM> (e.g., the gap between the gripper <NUM> and handle <NUM> is smaller than a predetermined distance), at least a portion of the balloon <NUM> is not covered by the valve sheath <NUM>, and the marker band <NUM> is hidden by the handle <NUM> and cannot be observed. When moving the gripper <NUM> away from the handle <NUM> in the proximal direction, the gap between the gripper <NUM> and the handle <NUM> increases. When the proximal movement of the gripper <NUM> causes the balloon <NUM> to be fully covered by the valve sheath <NUM>, the marker band <NUM> moves out of the handle <NUM> and can be observed in the gap, providing visual confirmation that the balloon is fully covered by the sheath <NUM>.

In some embodiments, the locking mechanism <NUM> can further include one or more detent elements <NUM> in the form of projections protruding from a proximal face <NUM> that defines the recessed region <NUM> at the proximal end portion of the handle <NUM>. In the embodiment depicted in <FIG>, two such detent elements 186a, 186b are shown, located between and immediately adjacent to the locked position (L) and unlocked position (U), respectively. The two detent elements 186a, 186b are angularly spaced apart from each other. The angle between the two detent elements 186a, 186b can be between about <NUM>° and about <NUM>°, desirably between about <NUM>° and about <NUM>°, and even more desirably between about <NUM>° and about <NUM>° (e.g., about <NUM>°).

The user-engageable tab <NUM> can be circumferentially turned by an operator to engage and/or disengage the detent elements <NUM> when moving between the locked position and the unlocked position. Specifically, referring to <FIG>, rotating the tab <NUM> across the first detent element 186a in a first angular direction (clockwise in the illustrated embodiment) brings the tab <NUM> into the locked position and rotating the tab <NUM> across the second detent element 186b in a second angular direction that is opposite the first angular direction (counterclockwise in the illustrated embodiment) brings the tab <NUM> into the unlocked position.

As shown in <FIG>, the detent elements <NUM> can be parts of a piston <NUM> that is axially moveable relative to the locker body <NUM>. The two detent elements 186a and 186b can be connected by a bridge member <NUM>. At least one biasing member can be provided to resiliently urge the detent elements 186a, 186b to a first position extending further into the recessed region <NUM> of the handle for engaging the user-engageable tab <NUM>. In the illustrated embodiment, for example, two coiled springs <NUM> are co-axially disposed on distal projections <NUM> connected to a distal side of the bridge <NUM>. The proximal ends of the springs <NUM> bear against the bridge <NUM> while the distal ends of the springs <NUM> bear against adjacent surfaces inside the handle <NUM>, thereby biasing the bridge <NUM> and the detent elements 186a, 186b in a proximal direction toward the tab <NUM>.

When the user-engageable tab <NUM> is rotated and passes over one of the detent elements 186a, 186b, the tab <NUM> presses against that detent element and moves both detent elements further into the interior handle to a second position against the bias of the springs <NUM>. When the tab <NUM> is in the locked position, such as shown in <FIG>, the detent element 186a is in the first position and can engage a side of the tab <NUM>. The biasing force of the springs <NUM> is selected to prevent inadvertent rotation of the tab <NUM> away from the locked position until actuated by a user. Similarly, when the tab <NUM> is in the unlocked position, the detent element 186b can engage a side of the tab <NUM>, thereby preventing inadvertent movement of the tab away from the unlocked position until actuated by a user. To move the tab <NUM> from the unlocked position to the unlocked position, or vice versa, the user applies sufficient manual force to the tab <NUM> to overcome the bias of the springs <NUM>, which allows the tab to move away from the unlocked position (or the locked position) and pass over the adjacent detent element.

Besides the visual indicators on the handle marking the locked and unlocked positions, the engagement and disengagement between the tab <NUM> and the detent elements <NUM> can create additional feedback (e.g., audible clicks and/or tactile vibrations) to the operator to indicate the position of the tab <NUM>.

In some embodiments, the handle <NUM> can have only one detent element. For example, in one implementation, the handle <NUM> has only detent element 186a for retaining the tab <NUM> in the locked position. In another implementation, the handle <NUM> has only detent element 186b for retaining the tab <NUM> in the unlocked position.

In some embodiments, the handle <NUM> can have respective slots (not shown) that are adjacent to the locked and unlocked positions and located distal to the recessed region <NUM>. The slots can be sized and shaped so as to receive the tab <NUM> when the tab is in the unlocked or locked positions. Thus, after moving the tab <NUM> to the locked or unlocked position, the tab <NUM> can be slid into the respective slot, thereby retaining the tab <NUM> in place until removed from the slot by the user. In alternative embodiments, other retaining mechanisms (e.g., buckles, clips, hook-and-loop fasteners, etc.) configured to prevent unintentional movement of the tab <NUM> from the locked or unlocked position can be incorporated into the handle.

As shown in <FIG>, the gripper <NUM> can include a body portion or housing <NUM> and an integrated Y-connector <NUM> disposed inside the body portion. The body portion <NUM> can define a lumen through which the Y-connector <NUM> extends. The body portion <NUM> can have a proximal opening <NUM>, a distal opening <NUM>, and a side opening <NUM>. In the depicted embodiment, the side opening <NUM> is located on the top surface of the gripper <NUM>, opposite the bottom surface 112b. In other embodiments, the side opening <NUM> can be located on one of the sidewalls (i.e., between the top and bottom surfaces) of the gripper <NUM>. The body portion <NUM> can also have two flat or substantially flat side surfaces <NUM> located on opposite sidewalls (one side surface <NUM> is shown in <FIG>; the other side surface <NUM> is on the opposite of the gripper). In certain examples, the side surfaces <NUM> can be textured (e.g., with grooves) so that the gripper <NUM> can be easily gripped by two fingers of the operator. In certain examples, the bottom surface 112b of the gripper can also be textured (e.g., with grooves) to resist movement when placing the gripper <NUM> on a flat surface.

In certain examples, the gripper <NUM> and the balloon shaft <NUM> can be rotatable about the central longitudinal axis 106a of the balloon shaft <NUM>. In certain examples, when the gripper <NUM> is rotated <NUM> degrees from the position shown in the drawings (either in clockwise or counter-clockwise direction) such that the side opening <NUM> points to sideways, one of the side surfaces <NUM> faces downward and can be coplanar or substantially coplanar with the bottom surface 102b of the handle <NUM>. This can be achieved, for example, by making the two side surfaces <NUM> and the bottom surface 112b equidistant from the axial axis of the gripper (which coincides with the central longitudinal axis 106a in <FIG>). Thus, the gripper <NUM> can have three contact surfaces, i.e., the bottom surface 112b and the two side surfaces <NUM>, each of which can be placed on an operating table (or other flat surfaces) while ensuring such contact surface is coplanar or substantially coplanar with the bottom surface 102b of the handle <NUM>.

As shown in <FIG>, the Y-connector <NUM> can have a main tubular portion <NUM> and a side tubular portion <NUM> extending angularly from the main tubular portion <NUM>. The main tubular portion <NUM> can extend through the lumen of the gripper <NUM> and be substantially parallel to the bottom surface 112b of the gripper <NUM>. In the depicted embodiment, a distal end portion 197d of the main tubular portion <NUM> is positioned adjacent the distal end 112d of the gripper <NUM> and a proximal end portion 197p of the main tubular portion <NUM> extends out of the proximal opening <NUM> of the gripper <NUM>. The side tubular portion <NUM> can extend through the side opening <NUM> of the gripper <NUM>.

According to one embodiment, the proximal ends of the balloon shaft <NUM>, the inner shaft <NUM>, and the hypotube <NUM> are all fixedly coupled to the main tubular portion <NUM> of the Y-connector <NUM>. In other embodiments, all of the proximal ends of the balloon shaft <NUM>, the inner shaft <NUM>, and the hypotube <NUM> can be fixedly coupled to the housing <NUM> of the gripper <NUM>. Yet in alternative embodiments, the proximal end of the hypotube <NUM> can be fixedly coupled to the body portion <NUM>, the proximal end of the inner shaft <NUM> can be fixedly coupled to the main tubular portion <NUM>, and the proximal end of the balloon shaft <NUM> can be fixed coupled to either the body portion <NUM> or the main tubular portion <NUM>.

The proximal end of the main tubular portion <NUM> has an opening through which a guidewire can be inserted into a lumen of the main tubular portion <NUM>. As noted above, the guidewire can also extend through the nosecone <NUM> and the lumen of the inner shaft <NUM>.

The side tubular portion <NUM> is fluidly coupled to the lumen of the balloon shaft <NUM>. Thus, side tubular portion <NUM> can serve as a balloon inflation port, through which an inflation fluid can be injected (e.g., via a syringe) into the balloon shaft <NUM>. In some embodiments, the source of the inflation fluid, such as a syringe, can be fluidly coupled to the inflation portion <NUM> by medical tubing, as known in the art. As described above with reference to <FIG>, the injected inflation fluid can flow through the annular space <NUM> between the balloon shaft <NUM> and the inner shaft <NUM> and into the balloon <NUM>, thereby inflating the balloon <NUM>. Conversely, the injected inflation fluid can be withdrawn (e.g., via a syringe) from the side tubular portion <NUM> so as to deflate the balloon <NUM>.

<FIG> shows a delivery apparatus <NUM>, according to another embodiment, that can be used to deliver a prosthetic valve, such as the prosthetic valve <NUM>. Similar to the delivery apparatus <NUM>, the delivery apparatus <NUM> includes a handle <NUM>, an outer shaft <NUM> connected to the distal end of the handle <NUM>, an intermediate or balloon shaft <NUM> extending through a lumen of the outer shaft <NUM>, an inner shaft <NUM> extending through a lumen of the balloon shaft <NUM>, and a nosecone <NUM> connected to the distal end of the inner shaft <NUM>. Similarly, the delivery apparatus <NUM> includes a gripper <NUM> which is located proximal to the handle <NUM> and is axially moveable relative to the handle <NUM>. Likewise, the delivery apparatus <NUM> can include a valve sheath or capsule <NUM> connected to the distal end of the outer shaft <NUM> and configured to cover the prosthetic valve <NUM> when the prosthetic valve is compressed over a balloon along the distal end portion of the delivery apparatus <NUM>. In addition, the delivery apparatus <NUM> can include an inline introducer <NUM> comprising a sheath <NUM> and a hub <NUM>. The outer shaft <NUM> can extend through the inline introducer <NUM> and can be axially moveable relative to the introducer <NUM>.

In contrast to the delivery apparatus <NUM> where the Y-connector <NUM> is disposed within the gripper <NUM>, the delivery apparatus <NUM> has a Y-connector <NUM> that is separate from (disposed outside of) the gripper <NUM>. Further, in contrast to the delivery apparatus <NUM> which has a locking mechanism <NUM> integrated into the handle <NUM>, the delivery apparatus <NUM> can have a removable locking member <NUM> that is a separate component from the handle <NUM>. For example, the locking member <NUM> can have a pair of resilient prongs <NUM>, which are separated from each other by a distance that is slightly smaller than the diameter of the balloon shaft <NUM>. Thus, by placing the prongs <NUM> of the locking member <NUM> against the shaft <NUM> and pressing the locking member <NUM> firmly against the shaft <NUM>, the prongs <NUM> will splay apart and slide along opposite sides of the shaft until the shaft <NUM> is located between the prongs <NUM>. In this manner, the prongs <NUM> form a snap-fit connection with the shaft <NUM>. Once placed on the shaft, the prongs <NUM> frictionally engage the outer surface of the shaft and resist axial movement of the locking member along the length of the shaft. Thus, when the locking member <NUM> is on the shaft, distal movement of the shaft <NUM> and the gripper <NUM> relative to the handle <NUM> is limited by contact between the locking member <NUM> and the proximal end of the handle <NUM>. The locking member <NUM> can be manually removed from the shaft <NUM> by pulling the locking member away from the shaft in a lateral direction (i.e., perpendicular to the length of the shaft <NUM>).

In some embodiments, the delivery apparatus <NUM> can include a hypotube (e.g., hypotube <NUM>) that extends over the balloon shaft <NUM>, similar to the hypotube <NUM> of the delivery apparatus <NUM>, in which case the locking member <NUM> can be placed on the hypotube to limit distal movement of the hypotube and the balloon shaft <NUM>.

Prior to insertion into a patient, the prosthetic valve <NUM> can be crimped around the balloon and the delivery sheath <NUM> can be advanced over the prosthetic valve so that it abuts the nose cone <NUM> (similar to <FIG>). The locking member <NUM> can then be placed on the shaft <NUM> adjacent the proximal end of the handle <NUM>. In this position, the locking member <NUM> can prevent distal movement of the shaft <NUM> and the prosthetic valve <NUM> relative to the handle <NUM> and the delivery sheath <NUM> and/or proximal movement of the handle <NUM> and the delivery sheath <NUM> relative to the shaft <NUM> and the prosthetic valve <NUM> to prevent premature advancement of the prosthetic valve <NUM> from the delivery sheath <NUM>. The prosthetic valve <NUM> and the distal end portion of the delivery apparatus <NUM> can be then be inserted into the patient's vasculature and advanced to the implantation site. When the prosthetic valve is at or adjacent the implantation site, the locking member <NUM> can be removed from the shaft <NUM>. Thereafter, the user can advance the prosthetic valve <NUM> from the delivery sheath <NUM> by pushing the gripping <NUM> distally relative to the handle <NUM> and/or pulling the handle <NUM> proximally relative to the gripper <NUM>.

In some embodiments, the prosthetic valve <NUM> can be mounted in a compressed state on the distal end of the delivery device <NUM> (or <NUM>) and advanced through the patient's vasculature (e.g., through a femoral artery and the aorta) until the prosthetic valve <NUM> reaches the target implantation site in the heart. The prosthetic valve <NUM> can then be expanded to its functional size by inflating the balloon on which the prosthetic valve <NUM> is mounted.

In another embodiment, a docking device or a docking station can be implanted at a target implantation site first. The docking device can then provide a landing zone into which the prosthetic valve <NUM> can be deployed, as described below. Such approach can be particularly helpful for transcatheter implantation of prosthetic valves at the sites with large annulus, where the prosthetic valve may not be large enough to sufficiently expand inside the native valve or other implantation or deployment site to be secured in place. One such example is replacing the pulmonary valve, which presents significant challenges because the pulmonary artery can have a wide variety of different shapes and sizes. These differences can be even more significant in pulmonary arteries that suffer from certain conditions and/or have been compromised by previous surgery. For example, the treatment of Tetralogy of Fallot (TOF) or Transposition of the Great Arteries (TGA) often results in larger and more irregularly shaped pulmonary arteries.

<FIG> shows one exemplary embodiment a docking device <NUM> configured to receive another transcatheter device, such as a transcatheter prosthetic valve <NUM>. The docking device <NUM> includes an expandable frame <NUM>, which is shown in its unconstrained, expanded condition. When expanded, the frame <NUM> can be configured or shaped to conform to an interior shape of a portion of the vasculature in which it is to be implanted, such as the pulmonary annulus. The frame <NUM> is desirable a wide stent comprised of a plurality of metal struts <NUM> that form cells <NUM>. The docking device <NUM> can include one or more sealing members <NUM> (see <FIG>), which can be made of fabric, polymer, or other covering and are attached to a portion of the frame <NUM>. The sealing members <NUM> can be configured to contact an interior surface of the circulatory system at the implantation site so as to inhibit or prevent paravalvular leakage.

The expandable frame <NUM> can be made from a highly resilient or compliant material to accommodate large variations in the anatomy. For example, the frame <NUM> 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 also be used. In the depicted embodiment, the frame <NUM> is self-expandable. In other embodiments, the frame can be manually expandable (e.g., expandable via balloon), or mechanically expandable. A self-expanding frame <NUM> may be made of a shape memory material such as, for example, nitinol.

The docking device <NUM> can also optionally include one or more valve seats <NUM> configured to receive and support the transcatheter prosthetic valve <NUM> after the docking device <NUM> is implanted in the circulatory system. The valve seats <NUM> can be attached to the frame <NUM> or integrally formed with the frame <NUM>. In addition, the docking device <NUM> can include one or more retaining members <NUM>, which can be any structure that sets the position of the docking device <NUM> in the circulatory system. In some embodiments, the retaining members <NUM> can be part of or define a portion of the frame <NUM> and/or sealing portion of the docking device <NUM>. In some embodiments, the retaining members <NUM> can be a separate component that is attached to the frame <NUM> of the docking device <NUM>. In the depicted example, the retaining members <NUM> comprise free ends of the metal struts <NUM> at the proximal inflow end <NUM> and distal outflow end <NUM> of the frame <NUM>. For example, the retaining members <NUM> can press against or into the inside surface or contour/extend around anatomical structures of the circulatory system to set and maintain the position of the docking device <NUM>.

In the depicted example, when fully expanded, the frame <NUM> can have an hourglass shape defined by a relatively wider proximal inflow portion <NUM> and distal outflow portion <NUM>, and a relatively narrower waist portion <NUM> between the inflow and outflow portions <NUM> and <NUM>. In certain embodiments, the narrow waist portion <NUM> can form the valve seat <NUM> when covered by an impermeable material, and the prosthetic valve <NUM> can expand in the narrow waist portion <NUM>. The frame <NUM> can also include one or more retaining tabs <NUM> extending from the inflow end <NUM> (or alternatively from the outflow end <NUM>), which can be releasably connected to a retaining member of a delivery catheter, as described below.

The illustrated docking device <NUM> and prosthetic valve <NUM> are particularly suited to be deployed in the pulmonary artery or right ventricular outflow tract for pulmonary valve replacement. However, the docking device <NUM> and prosthetic valve <NUM> can be deployed in any interior surface within the heart or a lumen of the body. For example, the various docking devices and valves described herein can be deployed in the superior vena cava, the inferior vena cava, the tricuspid valve, the mitral valve, the aortic valve, aorta, or other vasculature/lumens in the body. Further details regarding the docking device are disclosed in <CIT> and<CIT>.

As an example, <FIG> illustrates the prosthetic valve <NUM> received within the docking device <NUM> implanted in the circulatory system, such as in the pulmonary artery. In the depicted embodiment, a sealing member <NUM> provides a seal between the docking device <NUM> and an interior surface <NUM> of the circulatory system. The sealing members <NUM> can be formed by providing a blood impermeable material (e.g., a PET cloth) over the frame <NUM> or a portion thereof. In particular embodiments, the sealing member <NUM> can cover the lower (near the inflow end <NUM>), rounded, radially outward extending portion <NUM> of the frame <NUM>. In an exemplary embodiment, the sealing member <NUM> can extend from at least the portion <NUM> of the frame <NUM> to the valve seat <NUM>. This makes the docking device <NUM> impermeable from the portion <NUM> to the valve seat <NUM>. As such, all blood flowing in the direction from the inflow end <NUM> toward the outflow end <NUM> is directed to the valve seat <NUM> (and the prosthetic valve <NUM> once installed or deployed in the valve seat <NUM>).

In certain embodiments, the walls at the inflow portion <NUM> of the docking device <NUM> are impermeable to blood, but the walls at the outflow portion <NUM> are relatively open. In one embodiment, the inflow portion <NUM>, the waist portion <NUM>, and a portion of the outflow portion <NUM> are covered with a blood-impermeable fabric, which may be sewn onto the frame <NUM> or otherwise attached by a method known in the art. The impermeability of the inflow portion <NUM> of the frame <NUM> can help funnel blood into the docking device <NUM> and ultimately flow through the valve <NUM> that is to be expanded and secured within the docking device <NUM>.

From another perspective, this embodiment of a docking device is designed to seal at the proximal inflow portion <NUM> to create a conduit for blood flow. However, at least some of the distal rows of cells <NUM> can be generally left open and form a permeable portion <NUM>, thereby allowing the docking device <NUM> to be placed higher in the pulmonary artery without restricting blood flow. For example, the distal permeable portion may extend into the branch of the pulmonary artery and not impede or not significantly impede the flow of blood past the branch. In one embodiment, blood-impermeable cloth, such as a PET cloth for example, or other material covers the proximal inflow portion <NUM>, but the covering does not cover any or at least a portion of the distal outflow portion <NUM>. As one non-limiting example, when the docking device <NUM> is placed in the pulmonary artery, which is a large vessel, the significant volume of blood flowing through the artery is funneled into the valve <NUM> by the sealing member <NUM>. The sealing member <NUM> is fluid impermeable so that blood cannot pass through. Again, a variety of other biocompatible covering materials may be used such as, 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.

The valve seat <NUM> can provide a supporting surface for implanting or deploying the prosthetic valve <NUM> in the docking device <NUM>. The retaining members <NUM> can retain the docking device <NUM> at the implantation position or deployment site in the circulatory system. For example, the illustrated retaining members <NUM> have an outwardly curving flare that helps secure the docking device <NUM> within the pulmonary artery. In the depicted embodiment, when the docking device <NUM> is compressed by the interior surface <NUM>, the retaining members <NUM> can engage the surface <NUM> at an angle α (between the normal direction to the surface <NUM> and the tangent of the retaining member <NUM>) that can range between about <NUM> and <NUM> degrees, such as about <NUM> degrees. This inward bending of the retaining members <NUM> acts to retain the docking device <NUM> in the circulatory system. The retaining members <NUM> are at the wider inflow end <NUM> and outflow end <NUM> and press against the interior surface <NUM>. The flared retaining members <NUM> can engage into the surrounding anatomy in the circulatory system, such as the pulmonary space. In one exemplary embodiment, the flares can serve as a stop, which locks the device <NUM> in place. When an axial force is applied to the docking device <NUM>, the flared retaining members <NUM> are pushed by the force into the surrounding tissue to resist migration of the docking device <NUM>.

<FIG> shows an exemplary embodiment of a delivery apparatus <NUM> for delivering and deploying the docking device <NUM>. The delivery apparatus <NUM> can take a wide variety of different forms. In the illustrated example, the delivery apparatus <NUM> includes a handle <NUM>, an outer shaft <NUM> connected to the handle <NUM>, an inner shaft <NUM> extending through a lumen of the outer shaft <NUM>, a docking device retaining member <NUM> that is connected to the inner shaft <NUM>, and a nosecone <NUM> that is connected to the docking device retaining member <NUM> by a connecting tube <NUM>. The outer shaft <NUM> can be axially moveable relative to the inner shaft <NUM>, for example, by rotating a drive member <NUM> (e.g., a rotatable knob) located on the handle <NUM>. The distal end portion <NUM> of the outer shaft <NUM> can form a delivery sheath or capsule that is configured to extend over the docking device <NUM> during delivery. In addition, a guidewire <NUM> (see <FIG>) can extend through a lumen of the inner shaft <NUM> and the nosecone <NUM> such that the inner shaft <NUM> and outer shaft <NUM> can be routed over the guidewire to position the docking device <NUM> at the implantation site.

In a delivery configuration, the docking device <NUM> can be disposed along a distal end portion of the inner shaft <NUM> and retained in a compressed configuration by the delivery sheath <NUM>, which extends cover the radially compressed docking device. The retaining tabs <NUM> of the frame <NUM> can be releasably connected to the docking device retaining member <NUM> (see <FIG>). A radiopaque marker <NUM> can be placed along the delivery sheath <NUM>, either on the outer surface of the delivery sheath or embedded within the wall of the delivery sheath. The outer shaft <NUM> can be progressively retracted (e.g., by actuating the drive member <NUM>) in a proximal direction relative to the inner shaft <NUM>, the retaining member <NUM>, and the nosecone <NUM> to deploy the docking device <NUM>, as described below. Further details regarding the delivery apparatus <NUM> and methods for implanting the docking device <NUM> are disclosed in <CIT> and <CIT>.

<FIG> illustrate certain steps of implanting the docking device <NUM> and the prosthetic valve <NUM> at the RVOT for pulmonary valve replacement, according to one embodiment.

<FIG> shows a guidewire <NUM> inserted through a patient's vasculature and into the pulmonary bed. Specifically, the guidewire <NUM> can be advanced to the pulmonary artery <NUM> by way of the femoral vein, inferior vena cava, right atrium, tricuspid valve, right ventricle, and the right ventricular outflow tract. Under fluoroscopy, the delivery apparatus <NUM> (only the outer shaft <NUM> and the nosecone <NUM> are shown) that retains the docking device <NUM> can be delivered over the guidewire <NUM>. The delivery apparatus <NUM> can be advanced until the radiopaque marker <NUM> is positioned at a distal end of the intended landing zone <NUM> where the docking device <NUM> is to be deployed.

Then, as shown in <FIG>, the outer shaft <NUM> can be progressively retracted (e.g., by rotating the drive member <NUM> in a first direction) with respect to inner shaft <NUM> to deploy the docking device <NUM>. As the distal portion of the docking device <NUM> becomes uncovered by the outer shaft <NUM>, the distal portion of the frame <NUM> begins to self-expand. When the radiopaque marker <NUM> is at about the waist portion <NUM> of the frame <NUM>, the distal half the frame <NUM> is fully expanded at the intended landing zone <NUM>. When the frame is partially expanded, the deployment position of the docking device <NUM> can be reassessed. If repositioning of the docking device <NUM> is needed, the distal portion of the frame <NUM> can be compressed and recaptured by the delivery sheath <NUM> of the outer shaft <NUM>. This can be achieved, for example, by moving the outer shaft <NUM> distally (e.g., by rotating the drive member <NUM> in a second direction opposite the first direction) until it contacts the nosecone <NUM>. Then the radiopaque marker <NUM> can be repositioned relative to the intended landing zone <NUM> to redeploy the docking device <NUM>.

Further retracting the outer shaft <NUM> past the waist portion <NUM> can release the proximal half of the frame <NUM> from the delivery sheath <NUM>. When the outer shaft <NUM> is retracted to a position that exposes the retaining tabs <NUM>, the retaining tabs <NUM> can be released from the docking device retaining member <NUM> due to the expanding force of the frame <NUM>. Thus, as shown in <FIG>, the frame <NUM> can be fully expanded and frictionally engage the inner wall of the pulmonary artery (or right ventricular outflow tract), i.e., the docking device <NUM> is fully deployed at the intended landing zone <NUM>.

As shown in <FIG>, after deploying the docking device <NUM> at the intended landing zone <NUM>, the delivery apparatus <NUM> can be retracted from the patient's vasculature over the guidewire <NUM> while leaving the guidewire <NUM> in place. After withdrawing the delivery apparatus <NUM> from the patient's vasculature, the prosthetic valve <NUM> can then be delivered to and received by the docking device <NUM> via the delivery apparatus <NUM>, as described below (although the delivery apparatus <NUM> is described as an example for illustration, similar steps can be performed using the delivery apparatus <NUM>).

Before implanting the prosthetic valve <NUM>, the prosthetic valve <NUM> can be crimped on the balloon <NUM> and covered by the valve sheath <NUM> of the delivery apparatus <NUM> (see e.g., <FIG>). For pulmonary valve implantation, the prosthetic valve <NUM> is oriented so that its inflow end <NUM> is located proximal to the outflow end <NUM> when the valve <NUM> is crimped on the valve retaining portion <NUM> of the balloon <NUM> (see e.g., <FIG>). The gripper <NUM> and the handle <NUM> are axially separated from each other until the distal end 138d of the valve sheath <NUM> contacts the engagement end <NUM> of the nosecone <NUM> so that the valve sheath <NUM> completely covers the prosthetic valve <NUM>. Then, the locker body <NUM> on the handle <NUM> can be turned to the locked position so that the handle <NUM> and the gripper <NUM> are not axially moveable relative to each other. Thus, the nosecone <NUM> and the valve sheath <NUM> are locked together when navigating through patient's vasculature.

In one example embodiment, the nosecone <NUM>, the valve sheath <NUM>, and the sheath <NUM> of the inline introducer <NUM> are inserted together into the patient's vasculature (e.g., through a surgical opening in a femoral vein) as a single unit over the guidewire <NUM>, desirably with the distal end 116d of the sheath <NUM> adjacent or abutting the proximal end 138p of the valve sheath <NUM>.

After the sheath <NUM> is fully inserted into the vasculature (with the hub <NUM> remaining outside the patient's body), the hub <NUM> can be secured in place relative to the patient and/or the operating table (e.g., by clamping or other means). Thereafter, the shafts <NUM>, <NUM>, <NUM> of the delivery apparatus <NUM> can be advanced over the guidewire <NUM> and relative to the sheath <NUM> through the patient's vasculature (e.g., by pushing the outer shaft <NUM> or the handle <NUM>) until the valve sheath <NUM> is positioned at the intended landing zone <NUM> marked by the pre-implanted docking device <NUM>, as shown in <FIG>. Because the handle <NUM> is locked and cannot move relative to the gripper <NUM>, the outer shaft <NUM> (which is connected to the handle) and the valve sheath <NUM> (which is connected to the outer shaft <NUM>) cannot move axially relative to the balloon shaft <NUM> and the inner shaft <NUM> (both of which are connected to the gripper). Thus, during the advancement, the prosthetic valve <NUM> remains covered by the valve sheath <NUM> so as to protect against damage to the prosthetic valve as well as the inner wall of the vasculature and the tricuspid valve chordae tendineae.

After reaching the intended landing zone <NUM>, the delivery apparatus <NUM> can be manipulated so that the prosthetic valve <NUM> is placed within the waist <NUM> region of the docking device <NUM>. This can be confirmed, for example, by aligning the radiopaque marker <NUM> of the delivery apparatus <NUM> with the middle (i.e., the narrowest part) of the waist region <NUM> based on the fluoroscopic views.

Then, as shown in <FIG>, the outer shaft <NUM> and the valve sheath <NUM> connected thereto can be retracted in the proximal direction to uncover the prosthetic valve <NUM>. To retract the outer shaft <NUM> and the valve sheath <NUM>, the locker body <NUM> on the handle <NUM> can be turned to the unlocked position so that the handle <NUM> and the gripper <NUM> are axially moveable relative to each other. Therefore, by holding the gripper <NUM> stationary (thus maintaining the position of the balloon shaft <NUM>) while moving the handle <NUM> in the proximal direction, the outer shaft <NUM> and the valve sheath <NUM> can be retracted proximally relative to the balloon shaft <NUM> and the prosthetic valve <NUM>. Retraction of the outer shaft <NUM> and valve sheath <NUM> can be continued until the proximal end <NUM> of the handle <NUM> abuts the distal end 112d of the gripper <NUM>, whereby the valve sheath <NUM> is moved to the uncovered position and the prosthetic valve <NUM> is fully uncovered. Alternatively, the prosthetic valve <NUM> can be deployed from the valve sheath <NUM> by pushing the gripper <NUM> distally relative to the handle <NUM>.

As shown in <FIG>, after the prosthetic valve <NUM> is uncovered by the valve sheath <NUM>, the balloon <NUM> can be inflated, e.g., by injecting an inflation fluid into the balloon shaft <NUM> (e.g., through the balloon inflation port <NUM>, as shown in <FIG>). Inflation of the balloon <NUM> can cause radial expansion of the prosthetic valve <NUM> within the interior of the docking device <NUM>. In some embodiments, a slow controlled inflation of the balloon <NUM> may be administered during initial deployment of the prosthetic valve <NUM> to improve the stability of the delivery system and the prosthetic valve <NUM>. The fully expanded prosthetic valve <NUM> can be received by the docking device <NUM>. The position of the prosthetic valve <NUM> can be verified under fluoroscopy. If repositioning is necessary, the handle <NUM> and the gripper <NUM>, which can be held together as a single unit (i.e., they remain contact with each other), can be manipulated to slightly adjust the position and/or angle of the balloon shaft <NUM> and the prosthetic valve <NUM> as needed to ensure a secure fitting between the prosthetic valve <NUM> and the docking device <NUM>.

As shown in <FIG>, after the prosthetic valve <NUM> is fully expanded and securely docked to the docking device <NUM>, the balloon <NUM> can be deflated, e.g., by withdrawing the inflation fluid out of the balloon <NUM> and the balloon shaft <NUM>. The shafts <NUM>, <NUM>, <NUM> of the delivery apparatus <NUM> can be retracted, over the guidewire <NUM>, into the vena cava while maintaining the contact between the handle <NUM> and the gripper <NUM>. Then the deflated balloon <NUM> can be resheathed (i.e., captured or covered) by the valve sheath <NUM>.

Resheathing of the balloon <NUM> can be achieved, for example, by moving the gripper <NUM> in the proximal direction while holding the handle <NUM> stationary until the engagement end <NUM> of the nosecone <NUM> abuts the distal end 138d of the valve sheath <NUM>. As noted above, the distance between the flared portion <NUM> and the gripper <NUM> desirably is equal to or greater than the axial distance (D1) between the distal end 138d of the valve sheath <NUM> and the engagement end <NUM> of the nosecone <NUM> when the valve sheath <NUM> is in the uncovered position (see e.g., <FIG>). Thus, when proximal movement of the gripper <NUM> relative to the handle <NUM> is restricted because the flared portion <NUM> engages the end plate <NUM> inside the handle <NUM> (see e.g., <FIG>), it indicates that the engagement end <NUM> of the nosecone <NUM> contacts the distal end 138d of the valve sheath <NUM>, i.e., the balloon <NUM> is fully covered by the valve sheath <NUM>. In addition to or in lieu of relying the engagement between the flared portion <NUM> and the end plate <NUM>, the observation of the marker band <NUM> in the gap between the gripper <NUM> and the handle <NUM> can also indicate the end of hypotube travel and provide a visual confirmation that balloon is fully resheathed. Resheathing the balloon <NUM> can facilitate smooth retraction of the delivery apparatus <NUM> and prevent damage to the inner wall of the vasculature and the tricuspid valve chordae tendinae during the retraction.

After resheathing the balloon <NUM>, the shafts <NUM>, <NUM>, <NUM> of the delivery apparatus <NUM> can be retracted further as a single unit until the proximal end 138p of the valve sheath <NUM> abuts the distal end <NUM> of the sheath <NUM> (see e.g., <FIG>). Then, the entire delivery apparatus <NUM>, including the shafts <NUM>, <NUM>, <NUM> and the sheath <NUM>, can be retracted together out of the patient's vasculature. The guidewire <NUM> can then be removed as well.

It should be understood that the disclosed embodiments can be adapted to deliver and implant prosthetic devices in any of the native annuluses of the heart (e.g., the pulmonary, mitral, and tricuspid annuluses), and can be used with any of various delivery approaches (e.g., retrograde, antegrade, transseptal, transventricular, transatrial, etc.).

For purposes of this description, certain aspects, advantages, and novel features of the embodiments of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed embodiments, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed embodiments require that any one or more specific advantages be present or problems be solved. The technologies from any example can be combined with the technologies described in any one or more of the other examples. In view of the many possible embodiments to which the principles of the disclosed technology may be applied, it should be recognized that the illustrated embodiments are only preferred examples and should not be taken as limiting the scope of the disclosed technology.

As used in this application and in the claims, the singular forms "a," "an," and "the" include the plural forms unless the context clearly dictates otherwise. Additionally, the term "includes" means "comprises. " Further, the terms "coupled" and "connected" generally mean electrically, electromagnetically, and/or physically (e.g., mechanically or chemically) coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language.

As used herein, the term "proximal" refers to a position, direction, or portion of a device that is closer to the user and further away from the implantation site. As used herein, the term "distal" refers to a position, direction, or portion of a device that is further away from the user and closer to the implantation site. Thus, for example, proximal motion of a device is motion of the device away from the implantation site and toward the user (e.g., out of the patient's body), while distal motion of the device is motion of the device away from the user and toward the implantation site (e.g., into the patient's body). The terms "longitudinal" and "axial" refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

Directions and other relative references (e.g., inner, outer, upper, lower, etc.) may be used to facilitate discussion of the drawings and principles herein, but are not intended to be limiting. For example, certain terms may be used such as "inside," "outside,", "top," "down," "interior," "exterior," and the like. Such terms are used, where applicable, to provide some clarity of description when dealing with relative relationships, particularly with respect to the illustrated embodiments. Such terms are not, however, intended to imply absolute relationships, positions, and/or orientations. For example, with respect to an object, an "upper" part can become a "lower" part simply by turning the object over. Nevertheless, it is still the same part and the object remains the same. As used herein, "and/or" means "and" or "or", as well as "and" and "or".

As used herein, two lengths are deemed substantially identical if the difference between the two lengths is smaller than <NUM>% of the average of the two lengths.

In view of the above-described implementations of the disclosed subject matter, this application discloses the additional examples enumerated below. It should be noted that one feature of an example in isolation or more than one feature of the example taken in combination and, optionally, in combination with one or more features of one or more further examples are further examples also falling within the disclosure of this application.

The locker body can comprise a cylindrical portion and the user-engageable portion extending radially outwardly from the cylindrical portion, wherein the second shaft extends through the cylindrical portion, wherein the at least one detent element is positioned to engage the user-engageable portion when the locker body is in the locked position or the unlocked position.

The delivery apparatus can further comprise at least one biasing member configured to bias the at least one detent element in a direction toward the user-engageable portion.

The collet can comprise an end plate, a neck portion extending proximally from the end plate, and a plurality of arms extending proximally from the neck portion, wherein the second shaft extends through an opening on the end plate and a lumen of the neck portion, and the plurality of arms are disposed around the second shaft.

The arms and the neck portion are configured to be inserted into the locker lumen, wherein the neck portion is configured to threadably engage the internal threads of the locker body such that rotating the locker body toward the locked position causes the collet to move in a proximal direction and rotating the locker body toward the unlocked position causes the collet to move in a distal direction.

The locking mechanism can be so configured that when the locker body is in the locked position, distal end portions of the arms are inserted into and compressed radially inwardly by the proximal portion of the locker lumen, and when the locker body is in the unlocked position, the distal end portions of the arms move into the distal portion of the locker lumen and expand radially outwardly.

The second shaft can comprise a flared portion, the flared portion having a diameter that is larger than a diameter of the opening on the end plate of the collet such that proximal movement of the second shaft is blocked when the flared portion abuts the end plate of the collet.

The delivery apparatus can comprise first and second biasing members configured to bias the first and second detent elements in a direction toward the user-engageable portion.

In the method which is not covered by the claims the inserting the delivery apparatus into the vascular system comprises inserting the nosecone, the valve sheath, and the introducer together as a single unit until the sheath of the introducer is fully inserted into the vasculature, wherein a proximal end of the valve sheath abuts a distal end of the sheath of the introducer during the act of insertion.

The method can further comprise navigating the delivery apparatus within the vasculature until the prosthetic valve covered by the valve sheath is positioned at a target location at or adjacent a native valve.

In the method, the native valve is a pulmonary valve.

The method can further comprise implanting a docking device at the target location before implanting the prosthetic valve, wherein the docking device is configured to receive the prosthetic valve.

In the method, the docking device can comprise a self-expandable frame configured to securely engage an annulus of the native valve.

The method can further comprise verifying the prosthetic valve is positioned at the target location by aligning a radiopaque marker on the delivery apparatus with a predefined geometric marker of the docking device under fluoroscopy, wherein the radiopaque marker is positioned underneath the balloon.

The method can further comprise moving the locker body to the locked position before inserting the delivery apparatus into the vasculature.

The method can further comprise moving the locker body to the unlocked position after the prosthetic valve is positioned at the target location.

The method can further comprise unsheathing the prosthetic valve by keeping the gripper stationary while moving the handle proximally toward the gripper so that the valve sheath and the first shaft move proximally relative to the second shaft and the prosthetic valve, thereby exposing at least a portion of the prosthetic valve.

The unsheathing the prosthetic valve comprises moving the handle proximally until the proximal end of the handle contacts the gripper such that the prosthetic valve is completely uncovered by the valve sheath.

The method can further comprise inflating the balloon so as to radially expand the prosthetic valve.

The method can further comprise resheathing the balloon after the balloon is deflated by keeping the handle stationary while moving the gripper axially so that the second shaft and the balloon move proximally relative to the valve sheath and the first sheath, thereby covering at least a portion of the balloon with the valve sheath.

The resheathing the balloon can comprise moving the gripper proximally relative to the handle until a proximal end of the nosecone contacts a distal end of the valve sheath such that the balloon is completely covered by the valve sheath.

The method can further comprise retracting the delivery apparatus by moving the first shaft and the valve sheath proximally until the proximal end of the valve sheath contacts a distal end of the sheath of the introducer, and then retracting the introducer, the first shaft, and the valve sheath together as a single unit out of the vasculature.

The fourth shaft can be more rigid than the second shaft.

The Y-connector can have a first port, a second port, and a third port, wherein the second shaft, the third shaft, and the fourth shaft are connected to the first port.

The first port is located at a distal portion of the gripper, the second port extends out of a proximal opening of the gripper, and the third port extends out of an upper opening of the gripper.

Claim 1:
A delivery apparatus (<NUM>; <NUM>; <NUM>) for implanting a prosthetic heart valve (<NUM>) comprising:
a handle (<NUM>; <NUM>; <NUM>);
a first shaft (<NUM>) extending from a distal end of the handle (<NUM>; <NUM>; <NUM>);
a second shaft (<NUM>) extending through a lumen of the first shaft (<NUM>) and the handle (<NUM>; <NUM>; <NUM>); and
a gripper (<NUM>; <NUM>) located proximal to a proximal end (<NUM>) of the handle (<NUM>; <NUM>; <NUM>);
wherein a proximal end (<NUM>) of the second shaft (<NUM>) is connected to the gripper (<NUM>; <NUM>), and the gripper (<NUM>; <NUM>) is axially moveable relative to the handle (<NUM>; <NUM>; <NUM>) such that axial movement of the gripper (<NUM>; <NUM>) causes corresponding axial movement of the second shaft (<NUM>) relative to the first shaft (<NUM>); and
wherein the gripper (<NUM>; <NUM>) has a bottom surface (112b) that is substantially coplanar with a bottom surface (102b) of the handle (<NUM>; <NUM>; <NUM>).