DELIVERY APPARATUS AND METHODS FOR IMPLANTING PROSTHETIC HEART VALVES

A delivery apparatus for controlling implantation of a prosthetic heart valve includes a handle housing and a release mechanism mounted on the handle housing. The release mechanism can be operably coupled to at least one actuation shaft. Actuation of the release mechanism can cause a distal end portion of the actuation shaft to be connected to or released from the prosthetic heart valve. The handle also includes an indicator tab configured to indicate whether the actuation shaft if connected to or released from the prosthetic heart valve.

FIELD

The present disclosure relates to implantable, mechanically-expandable prosthetic devices, such as prosthetic heart valves, and to delivery apparatus and methods for implanting prosthetic heart valves.

BACKGROUND

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 apparatus and advanced through the patient's vasculature (e.g., through a femoral artery and the aorta) until the prosthetic heart valve reaches the implantation site in the heart. The prosthetic heart 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 heart valve, or by deploying the prosthetic heart valve from a sheath of the delivery apparatus so that the prosthetic heart valve can self-expand to its functional size.

Prosthetic heart valves that rely on a mechanical actuator for expansion can be referred to as “mechanically-expandable” prosthetic heart valves. Mechanically-expandable prosthetic heart valves can provide one or more advantages over self-expandable and balloon-expandable prosthetic heart valves. For example, mechanically-expandable prosthetic heart valves can be expanded to various diameters. Mechanically-expandable prosthetic heart valves can also be compressed after an initial expansion (e.g., for repositioning and/or retrieval).

Despite these advantages, mechanically-expandable prosthetic heart valves can present several challenges. For example, it can be difficult to release a mechanically-expandable prosthetic heart valve from the delivery apparatus. Premature retraction of the delivery apparatus may result in displacement of the prosthetic heart valve. Accordingly, there is a need for improved delivery apparatus and methods for implanting mechanically-expandable prosthetic heart valves.

SUMMARY

Described herein are prosthetic heart valves, delivery apparatus, and methods for implanting prosthetic heart valves. The disclosed delivery apparatus and methods can, for example, help to ensure that, after a prosthetic heart valve is deployed, the delivery apparatus is disengaged from the prosthetic heart valve before withdrawing the delivery apparatus. The delivery apparatus and methods disclosed herein are also relatively simple and/or easy to use. This can, for example, reduce the risk of causing displacement of the prosthetic heart valve during withdrawal of the delivery apparatus.

In one representative embodiment, a delivery apparatus for implanting a prosthetic heart valve is provided. The delivery apparatus can include a handle housing, a release mechanism mounted on the handle housing, and a gear assembly having one or more pinion gears and an indicator gear. Actuation of the release mechanism can cause rotation of the one or more pinion gears and the indicator gear. Each pinion gear can be connected to a proximal end portion of a corresponding actuation shaft. Rotation of the pinion gear can cause rotation of the corresponding actuation shaft such that a distal end portion of the actuation shaft can be connected to or released from the prosthetic heart valve. The indicator gear can be operably connected to an indicator tab. Rotation of the indicator gear can cause the indicator tab to move between a first position and a second position relative to the handle housing such that when the indicator tab is at the first position, the one or more actuation shafts are connected to the prosthetic heart valve, and when the indicator tab is at the second position, the one or more actuation shafts are released from the prosthetic heart valve.

In another representative embodiment, a delivery apparatus can include a handle and one or more actuation shafts. Each actuation shaft can have a proximal end portion connected to the handle and a distal end portion that is releasably couplable to the prosthetic heart valve. The handle can include a housing and a release mechanism mounted on the housing. Actuation of the release mechanism can cause the distal end portion of the actuation shafts to be connected to or released from the prosthetic heart valve. The handle can further include an indicator tab configured to indicate whether the one or more actuation shafts are connected to or released from the prosthetic heart valve.

Certain embodiments of the disclosure also concern an assembly including a prosthetic heart valve having one or more actuators and a delivery apparatus having a handle and one or more actuation shafts. Actuation of the actuators can cause radial expansion or compression of the prosthetic heart valve. Each actuation shaft can include a proximal end portion connected to the handle and a distal end portion that is releasably couplable to a corresponding actuator. The handle can include a release mechanism. Actuation of the release mechanism can cause the distal end portion of the actuation shafts to be connected to or released from the corresponding actuators. The handle can further include an indicator tab configured to indicate whether the one or more actuation shafts are connected to or released from the corresponding actuators.

Also disclosed herein is a method for implanting a prosthetic heart valve. The method can include deploying the prosthetic heart valve at a target location within a patient's body using a delivery apparatus. The delivery apparatus can include a handle and at least one actuation shaft that is releasably couplable to an actuator of the prosthetic heart valve. The method can further include radially expanding the prosthetic heart valve, releasing the actuation shaft from the actuator, and confirming release of the actuation shaft from the actuator based on an indicator on the handle.

Certain embodiments of the disclosure also concern a delivery apparatus for controlling implantation of a prosthetic heart valve. The delivery apparatus can include a handle housing and a release mechanism mounted on the handle housing. The release mechanism can be operably coupled to at least one actuation shaft, and actuation of the release mechanism can cause a distal end portion of the actuation shaft to be connected to or released from the prosthetic heart valve. The delivery apparatus can also include an indicator tab configured to indicate whether the actuation shaft if connected to or released from the prosthetic heart valve.

Also disclosed herein is a delivery apparatus for implanting a prosthetic heart valve. The delivery apparatus can include a handle having a release mechanism and at least one actuation shaft connected to the handle. The actuation shaft can be configured to be releasably connected to the prosthetic heart valve and cause radial expansion or compression of the prosthetic heart valve. Actuation of the release mechanism can cause a distal end portion of the actuation shaft to be connected to or released from the prosthetic heart valve. The release mechanism can be operatively connected to an indicator which is configured to indicate whether the actuation shaft is connected to or released from the prosthetic heart valve.

The various innovations of this disclosure can be used in combination or separately. This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the disclosure will become more apparent from the following detailed description, claims, and accompanying figures.

DETAILED DESCRIPTION

General Considerations

For purposes of this description, 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/or cardiac vessels, 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 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”.

Exemplary Embodiments

FIG.1shows a delivery assembly10, according to one embodiment. In the illustrated embodiment, the delivery assembly10includes a prosthetic heart valve100and a delivery apparatus200. The prosthetic valve100can be configured to replace a native heart valve (e.g., aortic, mitral, pulmonary, and/or tricuspid valves). As shown, the prosthetic valve100can be releasably coupled to a distal end portion of the delivery apparatus200. The delivery apparatus200can be used to deliver and implant the prosthetic valve100in the native heart valve of a patient (see, e.g.,FIGS.16-19). Additional details regarding the prosthetic valve100and the delivery apparatus200are provided below.

FIG.2shows the prosthetic valve100. As shown, the prosthetic valve100can have three main components: a frame102, a valve structure104, and one or more actuators106(e.g., three actuators in the illustrated embodiment). The frame102(which can also be referred to as “a stent” or “a support structure”) can be configured for supporting the valve structure104and for securing the prosthetic valve100within a native heart valve. The valve structure104can be coupled to the frame102and/or to the actuators106. The valve structure104can be configured to allow blood flow through the prosthetic valve100in one direction (i.e., antegrade) and to restrict blood flow through the prosthetic valve100in the opposition direction (i.e., retrograde). The actuators106can be coupled to the frame102and be configured to adjust expansion of the frame102to a plurality of configurations including one or more functional or expanded configurations (e.g.,FIGS.2-3), one or more delivery or compressed configurations (e.g.,FIG.4), and/or one or more intermediate configurations between the functional and delivery configurations. It should be noted that the valve structure104of the prosthetic valve100is not shownFIGS.1and3-4for purposes of illustration.

Referring toFIG.3, the frame102of the prosthetic valve100has a first end108and a second end110. In the illustrated embodiment, the first end108of the frame102is an inflow end and the second end110of the frame102is an outflow end. In other embodiments, the first end108of the frame102can be the outflow end and the second end110of the frame102can be the inflow end.

The frame102can be made of any of various suitable materials, including biocompatible metals and/or biocompatible polymers. Exemplary biocompatible metals from which the frame can be formed include stainless steel, cobalt chromium alloy, and/or nickel titanium alloy (which can also be referred to as “NiTi” or “nitinol”).

Referring still toFIG.3, the frame102includes a plurality of interconnected struts112arranged in a lattice-type pattern. InFIG.3, the frame102of the prosthetic valve100is in a radially expanded configuration, which results in the struts112of the frame102extending diagonally relative to a longitudinal axis of the prosthetic valve100. In other configurations, the struts112of the frame102can be offset by a different amount than the amount depicted inFIG.3. For example,FIG.4shows the frame102of the prosthetic valve100in a radially compressed configuration. In this configuration, the struts112of the frame102extend parallel (or at least substantially parallel) to the longitudinal axis of the prosthetic valve100.

To facilitate movement between the expanded and compressed configurations, the struts112of the frame102can be pivotably coupled to one another at one or more pivot joints along the length of each strut. For example, each of the struts112can be formed with apertures at opposing ends and along the length of the strut. The frame102can include hinges at the locations where struts112overlap and are pivotably coupled together via fasteners such as rivets or pins114that extend through the apertures of the struts112. The hinges can allow the struts112to pivot relative to one another as the frame102moves between the radially expanded and the radially compressed configurations, such as during assembly, preparation, and/or implantation of the prosthetic valve100.

In some embodiments, the frame102can be constructed by forming individual components (e.g., the struts112and pins114of the frame102) and then mechanically assembling and coupling the individual components together. In other embodiments, the struts are not coupled to each other with respective hinges but are otherwise pivotable or bendable relative to each other to permit radial expansion and contraction of the frame. For example, a frame can be formed (e.g., via laser cutting, electroforming or physical vapor deposition) from a single piece of material (e.g., a metal tube). Further details regarding the construction of frames and prosthetic valves are described in U.S. Publication Nos. 2018/0153689, 2018/0344456, and 2019/0060057, U.S. Application No. 62/869,948, and International Application No. PCT/US2019/056865, which are incorporated by reference herein. Additional examples of expandable prosthetic valves that can be used with the delivery apparatus disclosed herein are described in U.S. Publication Nos. 2015/0135506 and 2014/0296962, which are incorporated by reference herein.

Referring again toFIG.2, the valve structure104of the prosthetic valve100can be coupled to the frame102. The valve structure104can be configured to allow blood flow through the prosthetic valve100from the inflow end108to the outflow end110and to restrict blood from through the prosthetic valve100from the outflow end110to the inflow end108. The valve structure104can include, for example, a leaflet assembly comprising one or more leaflets116(e.g., three leaflets in the illustrated embodiment).

The leaflets116of the prosthetic valve100can be made of a flexible material. For example, the leaflets116of the leaflet assembly can be made from in whole or part, biological material, bio-compatible synthetic materials, or other such materials. Suitable biological material can include, for example, bovine pericardium (or pericardium from other sources).

Referring toFIG.2, the leaflets116can be arranged to form commissures118(e.g., pairs of adjacent leaflets), which can, for example, be mounted to respective actuators106. Further details regarding prosthetic heart valves, including the manner in which the valve structure104can be coupled to the frame102of the prosthetic valve100, can be found in U.S. Pat. Nos. 6,730,118, 7,393,360, 7,510,575, 7,993,394, and 8,652,202, and U.S. Publication No. 2018/0325665, which are incorporated by reference herein.

The valve structure104can be coupled to the actuators106. For example, the commissures118of the valve structure104can be coupled to the housing members122of the actuators106. Additional details regarding coupling the valve structure to the actuators can be found, for example, in U.S. Application No. 62/869,948.

As shown inFIG.3, the actuators106of the prosthetic valve100can be mounted to and spaced circumferentially around the inner surface of the frame102. The actuators106can be configured to, among other things, radially expand and/or radially compress the frame102. The actuators106can also be configured to lock the frame102at a desired expanded configuration. Accordingly, the actuators106can also be referred to as “locking mechanisms.” Each of the actuators106can be configured to form a releasable connection with one or more respective actuation shafts of a delivery apparatus, as further described below.

FIGS.5-6illustrate one exemplary embodiment of an actuator106. As shown, the actuator106can include a rack member120(which can also be referred to as an “actuation member”), a housing member122(which can also be referred to as a “support member”), and a locking member124. The rack members120can be coupled to the frame102of the prosthetic valve100at a first axial location (e.g., toward the inflow end108of the frame102), and the housing members122can be coupled to the frame at a second axial location (e.g., toward the outflow end110of the frame102). The rack members120can extend through and be axially movable relative to respective housing members122. Thus, relative axial movement between the rack members120and the housing members122cab apply axially directed forces to the frame102and result in radial expansion/compression of the frame102as the struts112of the frame102pivot relative to each other about the pins114. For example, moving the rack members120proximally (e.g., up in the orientation depicted inFIGS.5-6) relative to the housing members122can radially expand the frame102(e.g.,FIG.3). Conversely, moving the rack members120distally (e.g., down in the orientation depicted inFIGS.5-6) relative to the housing members122can radially compress the frame102(e.g.,FIG.4).

As shown inFIG.6, one or more of the rack members120can include a segment with a plurality of teeth126. The locking member124can be coupled to a respective housing member122and include a pawl128biased to engage the teeth126of the rack member120. In this manner, the rack member120and the locking member124can form a ratchet-type mechanism that allows the rack member120to move proximally relative to the housing member122(thereby allowing expansion of the prosthetic valve100) and that restricts the rack member120from moving distally relative to the housing member122(thereby restricting compression of the prosthetic valve100).

In the illustrated embodiment, the locking member124is integrally formed with the housing member122as a unitary structure. In other embodiments, the locking member124and the housing member122can be formed as separate components that are coupled together (e.g., with fasteners, adhesive, welding, and/or other means for coupling).

It should be understood that the actuator106described above is merely one exemplary, but non-limiting, embodiment. For example, in other embodiments, the actuator can be configured to have a fixed inner member and a moveable outer member that annularly surrounds the inner member. To expand the prosthetic valve, the outer member can be configured to hold the inflow end (or outflow end) of the prosthetic valve stationary and the inner member can be configured to pull (or push) the outflow end (or inflow end) toward the inflow end (or outflow end) of the prosthetic valve. More generally, the actuator can be configured to have two members that can be moved axially relative to each other. In some embodiments, the two members can be arranged side-by-side instead of coaxially. To expand the prosthetic valve, one member can be configured to hold the inflow end (or outflow end) of the prosthetic valve stationary and the other member can be configured to pull (or push) the outflow end (or inflow end) toward the inflow end (or outflow end) of the prosthetic valve. Further, locking of the prosthetic valve can be implemented by means other than the ratchet-type mechanism, such as using an axially moveable locking nut as described in PCT Application PCT/US2020/013429, which is incorporated by reference herein.

In the illustrated embodiment, the prosthetic valve100includes three actuators106. In other embodiments, a greater or fewer number of actuators can be used. For example, in one embodiment, the prosthetic valve can have one actuator. As another example, the prosthetic valve can have two actuators. In yet another example, a prosthetic valve can have 4-15 actuators.

Although not shown, the prosthetic valve100can also include one or more skirts or sealing members. For example, the prosthetic valve100can include an inner skirt mounted on the inner surface of the frame102. The inner skirt can function as a sealing member to prevent or decrease perivalvular leakage, to anchor the leaflets116to the frame102, and/or to protect the leaflets116against damage caused by contact with the frame102during crimping and during working cycles of the prosthetic valve100. The prosthetic valve100can also include an outer skirt mounted on the outer surface of the frame102. The outer skirt can function as a sealing member for the prosthetic valve by sealing against the tissue of the native valve annulus and thus reducing paravalvular leakage around the prosthetic valve. The inner and outer skirts can be formed from any of various suitable biocompatible materials, including any of various synthetic materials (e.g., PET) or natural tissue (e.g., pericardial tissue). The inner and outer skirts can be mounted to the frame using sutures, an adhesive, welding, and/or other means for attaching the skirts to the frame.

FIGS.7-10show the delivery apparatus200and its components, which can also be referred to as a “valve catheter” or a “delivery catheter.” As shown, the delivery apparatus200can include a handle202, a first shaft204, a second shaft206, one or more support sleeves208(e.g., three in the illustrated embodiment), one or more actuation shafts210(e.g., three in the illustrated embodiment), an optional recompression shaft212, a nosecone shaft214, and a nosecone216. The handle202can be configured for manipulating the shafts and sleeves relative to each other. The prosthetic heart valve100can be releasably coupled to the distal end portion of the delivery apparatus200(see, e.g.,FIGS.11-13), and the delivery apparatus200can be used for positioning the prosthetic valve100, and/or for expanding, compressing, and locking the prosthetic valve100in a desired radially expanded configuration.

In the illustrated embodiment, the delivery apparatus200includes three pairs of support sleeves208and actuation shafts210(i.e., one pair of a support sleeve208and an actuation shaft210for each actuator106of the prosthetic valve100). In other embodiments, the delivery apparatus200can have less than three (e.g., 1-2) or more than three (e.g., 4-15) pairs of support sleeves208and actuation shafts210, depending on the number of actuators a prosthetic valve includes.

The handle202of the delivery apparatus200can have one or more mechanisms configured to move the shafts and sleeves relative to each other. For example, as shown inFIG.7, the handle202includes a first mechanism218, a second mechanism220, a third mechanism222, and/or a fourth mechanism224.

The first mechanism218of the handle202can be coupled to the first and second shafts204,206and be configured to move the first and second shafts204,206axially relative to each other. As further explained below, the first mechanism218of the handle202can be used to deploy the prosthetic valve100from the delivery capsule of the first shaft204(seeFIG.17). As such, the first mechanism218can be referred to as “a deployment mechanism.”

In the illustrated embodiment, the first mechanism218includes a first knob226configured for actuating the first mechanism218. Although not shown, in other embodiments, the first mechanism218can include various other types of actuators configured for actuating the first mechanism218, such as buttons, switches, etc. The first mechanism218can also include one or more other non-illustrated components (such as electric motors, rotatable shafts, drive screws, gear assemblies, etc.) configured to facilitate and/or restrict relative axial movement between the first and second shafts204,206. For example, the first mechanism218can be configured such that rotating the first knob226(and/or an electric motor) relative to a housing228of the handle202results in relative axial movement between the first and second shafts204,206.

The second mechanism220of the handle202can be coupled to the actuation shafts210and be configured to move the actuation shafts210axially relative to the support sleeves208. When the prosthetic valve100is coupled to the delivery apparatus200via the actuation shafts210, the second mechanism220of the handle202can be used to radially expand and/or compress the prosthetic valve100, as further explained below. Accordingly, the second mechanism220can be referred to as “an actuation mechanism” and/or “an expansion mechanism.”

In the illustrated embodiment, the second mechanism220includes a second knob230configured for actuating the second mechanism220. In other embodiments, the second mechanism220can include various other types of actuators. Although not shown, the second mechanism220can also include one or more additional components configured to facilitate and/or restrict relative axial movement of the actuation shafts210relative to the support sleeves208. For example, the second mechanism220can include electric motors, drive screws, gear assemblies, and/or other components. In some embodiments, the second mechanism220can be configured such that rotating the second knob230(and/or an electric motor) relative to the housing228of the handle results in relative axial movement between the actuation shafts210and the support sleeves208.

The third mechanism222of the handle202can also be coupled to the actuation shafts210and be configured to rotate the actuation shafts210relative to the support sleeves208. In this manner, the third mechanism222can be used to simultaneously couple and release the actuation shafts210to/from the prosthetic valve100, as further described below. Thus, the third mechanism222can be referred to as “a release mechanism” or “a coupling mechanism.”

In the illustrated embodiment, the third mechanism222includes a third knob232configured for actuating the third mechanism222. In other embodiments, the third mechanism222can include various other types of actuators. The third mechanism222can also include one or more other components (e.g., a gear assembly and/or an electric motor) configured to facilitate and/or restrict relative rotational movement between the actuation shafts210and the support sleeves208. For example, the third mechanism222can be configured such that rotating the third knob232relative to the housing228results in rotation of the actuation shafts210relative to the support sleeves208.

The fourth mechanism224of the handle202can be coupled to the nosecone shaft214and be configured to move the nosecone shaft214and the nosecone216axially relative to the first and second shafts204,206. As such, the fourth mechanism224can be referred to as a “nosecone mechanism.”

In the illustrated embodiment, the fourth mechanism224includes a slider234configured for actuating the fourth mechanism224. Although not shown, the fourth mechanism224can include various other components configured to facilitate and/or restrict relative axial movement of the nosecone shaft214and the first and second shafts204,206. For example, in some embodiments, the fourth mechanism224can include one or more biasing members (e.g., springs) configured to bias the nosecone shaft214to a pre-determined axial position relative to the first and second shafts204,206. In such embodiments, the slider234can be biased to a particular axial position relative to the housing228(e.g., to a proximal position). The nosecone shaft214can be moved axially relative to the first and second shafts204,206by sliding the slider234relative to the housing228with sufficient force to overcome the opposing force of the biasing members. Upon release, the slider234can return to the biased position. In other embodiments, the fourth mechanism can include a rotatable knob, an electric motor, and/or a drive screw configured to convert relative rotational movement between the knob (and/or motor) and the housing into relative axial movement between the nosecone shaft and the first and second shafts.

Referring now toFIGS.7-8, a proximal end portion of the first shaft204can be coupled to and extends distally from the handle202. The first shaft204can have a lumen for housing the second shaft206of the delivery apparatus200. The distal end portion of the first shaft204can be configured to receive the prosthetic valve100in the radially compressed configuration (seeFIGS.14-17). As such, the first shaft204can be referred to as “a sheath” or “a delivery capsule”. Alternatively, the delivery capsule can be a separately formed component coupled to the distal end portion of the first shaft204.

As shown inFIGS.8-9, the second shaft206can extend coaxially through and be axially movable relative to the first shaft204. The second shaft206can include a plurality of lumens extending axially therethrough and can thus be referred to as “a multi-lumen shaft.” For example, as shown inFIG.9, the second shaft206can include one or more first lumens236(e.g., three in the illustrated embodiment) spaced circumferentially relative to each other. The first lumens236can be configured to receive respective actuation shafts210and/or support sleeves208. In the illustrated embodiment, the first lumens236are evenly spaced relative to each other (i.e., spaced apart by about 120 degrees). In other embodiments, the first lumens236can be non-evenly spaced relative to each other.

In some embodiments, the second shaft206can also include one or more additional lumens. For example, as shown inFIG.9, the second shaft206can include a recompression lumen238and a guidewire lumen240. The guidewire lumen240can be radially centrally disposed in the second shaft206. The recompression lumen238can be disposed radially outwardly relative to the guidewire lumen240. In some embodiments, the recompression lumen238can be radially aligned with and/or spaced circumferentially relative to the first lumens236.

In alternative embodiments, the second shaft206can have only one central lumen through which all the actuation shafts210and/or support sleeves208extend. Optionally, other shafts (e.g., the recompression shaft212and/or the nosecone shaft214described below) can also extend through such central lumen.

The support sleeves208can extend distally from respective first lumens236of the second shaft206and can be configured to contact the actuators106of the prosthetic valve100(seeFIG.12). The support sleeves208can be relatively more rigid than the actuation shafts210. As such, the support sleeves208can be used to apply distally-directed forces to the housing members122of the actuators106, which can oppose proximally-directed forces applied to the rack members120of the actuators106by the actuation shafts210of the delivery apparatus200, thereby enabling expansion of the prosthetic valve100caused by relative axial movement between the rack members120and the housing members122of the actuators106.

In the illustrated embodiment, the support sleeves208can be relative short tubes that are coupled to the distal end portion of the second shaft206but do not extend all the way through the second shaft206to the handle202. The sleeves208can, in some instances, be secured to the inner surfaces of the second shaft206that define the first lumens236(e.g., via adhesive). In some embodiments, proximal end portions of the support sleeves208can be coupled to the handle202, and the support sleeves208can extend through respective first lumens236of the second shaft206and beyond the distal end of the second shaft206. In either instance, each of the support sleeves208can include a lumen configured to receive a respective actuation shaft210, as shown inFIG.9.

The actuation shafts210can extend distally from the handle202, through respective first lumens236of the second shaft206, and through the lumens of respective support sleeves208. The distal end portions of the actuation shafts210can include mating features configured to releasably couple the actuation shafts to the actuators106of the prosthetic valve100. For example, as shown inFIGS.10-12, the distal end portions of the actuation shafts210can include external threads242configured to mate with corresponding internal threads130of the rack member120of the actuators106. In other embodiments, the distal end portions of the actuation shafts210can have internal threads that are configured to mate with corresponding external threads of the rack member120of the actuators106. Alternative coupling mechanism between the distal end portions of the actuation shafts210and the rack member120can be used.

In some embodiments, the actuation shafts210can be relatively flexible members. For example, the actuation shafts can be wires, cables, cords, sutures, etc. In other embodiments, the actuation shafts can be relatively rigid members, such as a rod. In other embodiments, the actuation shafts210can include one or more relatively flexible segments (e.g., at the distal end portions) and one or more relatively rigid segments (e.g., at the proximal end portions).

Referring toFIG.8, the recompression shaft212can extend from the handle202through the recompression lumen238of the second shaft206. As shown inFIG.9, the recompression shaft212can have a lumen244through which a recompression member246(e.g., wire, cable, suture, etc.) extends. As shown inFIG.13, the recompression member246can extend around the prosthetic valve100in a lasso-like manner. As such, the recompression member246can be used to recompress the prosthetic valve100by tensioning and thus constricting the recompression member246around the prosthetic valve100.

The prosthetic valve100can be coupled to a distal end portion of the delivery apparatus200to form the delivery assembly (seeFIGS.11-13), and the delivery apparatus200can be used to implant the prosthetic valve100within a patient's body (seeFIGS.13-19). The prosthetic valve100can be coupled to the delivery apparatus200by positioning the delivery apparatus200in the configuration shown inFIG.8. With the prosthetic valve100in the radially expanded configuration, the prosthetic valve100can be positioned over a proximal portion of the nosecone216and the nosecone shaft214and optionally within the loop of the recompression member246, as shown inFIG.13. The actuators106of the prosthetic valve100can be positioned adjacent the distal ends of the actuation shafts210, as shown inFIG.11. The actuation shafts210can then be inserted into the housing members122of the actuators106and threadably coupled to the rack members120of the actuators106, as shown inFIG.12.

With the prosthetic valve100releasably coupled to the delivery apparatus200(seeFIG.13), the prosthetic valve100can be radially compressed by actuating the actuators106, for example, by tensioning the recompression member246, and/or by inserting the prosthetic valve100and delivery apparatus200into a crimping device. Additional details about an exemplary crimping device for mechanically-expandable prosthetic valves can be found in U.S. Application No. 62/876,206, which is incorporated by reference herein.FIG.14shows the prosthetic valve100in a radially compressed configuration. The first shaft204of the delivery apparatus200can then be advanced over the second shaft206of the delivery apparatus200and the prosthetic valve100such that the prosthetic valve100is disposed within the lumen of the first shaft204and the distal end of the first shaft204abuts the nosecone216, as shown inFIG.15. This can be accomplished, for example, by actuating the first mechanism218of the handle202.

The distal end portion of the delivery assembly10can then be inserted into a patient's vasculature, and the prosthetic valve100can be advanced to an implantation location using the delivery apparatus200. For example,FIGS.16-19show an exemplary implantation procedure for implanting the prosthetic valve100within a patient's heart300using a transfemoral delivery procedure. In other embodiments, various other delivery procedures can be used, such as transventricular, transapical, transseptal, etc.

Referring toFIG.16, the distal end portion of the delivery assembly10can be inserted into a patient's vasculature such that the first shaft204extends through the patient's aorta302and such that the nosecone216extends through the patient's native aortic annulus304and into the left ventricle306of the patient's heart300. Turning toFIG.17, the prosthetic valve100can be deployed from the first shaft204of the delivery apparatus200by actuating the first mechanism218of the handle202, which moves the first shaft204of the delivery apparatus200proximally relative to the second shaft206of the delivery apparatus200(and/or moves the second shaft206distally relative to the first shaft204). The first shaft204can be moved further proximally such that the support sleeves208are exposed from the distal end of the first shaft204(see, e.g.,FIG.14).

As shown inFIG.18, the prosthetic valve100can then be radially expanded. This can be accomplished, for example, by actuating the second mechanism220of the handle202such that the actuation shafts210and the rack members120of the actuators106(which are coupled to the actuation shafts210) can move proximally relative to the support sleeves208and the housing members122of the actuators106(which abut the distal ends of the support sleeves208). When the prosthetic valve100is desirably positioned and secured within the native aortic annulus304, the locking members124can engage the rack members120to retain the prosthetic valve100in the expanded state.

If re-positioning of the prosthetic valve is desired, the second mechanism202can be used to actuate the actuators106to radially compress the prosthetic valve100. In lieu of or in addition to using the second mechanism202, the prosthetic valve100can be recompressed and repositioned and/or retrieved using the recompression member246. In some instances, the recompression member246can radially compress the prosthetic valve to a diameter that is smaller than is possible using only the actuators106. It should be noted that, for purposes of illustration, the recompression shaft212and the recompression member246are not shown inFIGS.17-18, and that the nosecone shaft214and the nosecone216are not shown inFIGS.18-19.

Once expanded and secured, the prosthetic valve100can then be released from the delivery apparatus200, as shown inFIG.19. This can be accomplished by actuating the third mechanism222of the handle202. This can rotate the actuation shafts210of the delivery apparatus200relative to the rack members120of the prosthetic valve100, thereby de-coupling the threads242of the actuation shafts210from the threads130of the rack members120. The actuation shafts210, the support sleeves208, and the second shaft206can then be withdrawn into the first shaft204, and the delivery apparatus200can be removed from the patient's body.

Example embodiments of the handle202, including certain exemplary embodiments of the first mechanism (i.e., the deployment mechanism)218, the second mechanism (i.e., the expansion mechanism)220, the third mechanism (i.e., the release mechanism)222, and the fourth mechanism (i.e., the nosecone mechanism)224, are described in Provisional U.S. Application No. 62/945,039, which is incorporated by reference herein.

As an example,FIGS.20A-Bshows an enlarged view in perspective of some of the internal components of the handle202in the vicinity of the third mechanism222. As shown, the third knob232can be configured to drive a gear train that include an annular driver gear344and a plurality of driven pinion gears356(three pinion gears are shown). The gear train can further include one or more idler gears350(two idler gears are shown). According to some embodiments, the third knob232can be attached to the annular driver gear344, such that rotation of the third knob232in a clockwise or counterclockwise direction can cause rotation of the annular driver gear344in the same direction. According to some embodiments, the third knob232can have a plurality of knob mating projections322, extending radially inward and received within respective driver gear mating recesses346.

The annular driver gear344can have driver gear inner teeth348that mesh with idler gear teeth352. The idler gear teeth352in turn can mesh with pinion gear teeth358. As shown, the driver gear344can be meshed with, and configured to drive, two idler gears350, one of which is meshed with, and configured to drive, two pinion gears356, while the other idler gear350can be meshed with, and configured to drive, a single third pinion gear356.

While two idler gears are shown, it will be understood that any number of idler gears may be used according to design requirements. While idler gears may be used to translate rotational movement to pinion gears that might be offset from the driver gear teeth348, other embodiments may exclude idler gears, for example if the pinion gears356can be designed so as to directly contact and mesh with the driver gear teeth348.

According to some embodiments, each pinion gear356can have a pinion gear bore360, configured to receive an actuation shaft210therein. According to some embodiments, the gear bore360can have a non-circular feature, such as a flat edge362, wherein the non-circular profile of the bore360matches a non-circular profile of a portion of the actuation shaft210extending therethrough. This non-circular profile allows the actuation shaft210to freely move axially in a proximal or a distal direction relative to the pinion gear356, for example, when actuating the second mechanism220of the handle202. Yet, as the pinion gear356is driven, for example by the driver gear344via an idler gear350, the actuation shaft210can rotate therewith in the same direction.

When the third knob232is rotated in a specific direction (which can be clockwise or counterclockwise), all actuation shafts210can be rotated via the gear train (i.e., via the driver gear344, the idler gears350and the driven pinion gears356). Accordingly, the distal end portions of the actuation shafts210can be unthreaded and disengaged from the respective rack members120.

According to some embodiments, the handle202can further include a safety knob364configured to slide into a recess366within the third rotatable knob232, for example, along a slot368located on the housing228of the handle202. In this position, the third rotatable knob232is prevented from rotating in any direction. This can serve as a safety measure, so as to prevent unintentional disengagement of the delivery apparatus from the prosthetic valve. Once the prosthetic valve is sufficiently expanded and positioned at the implantation site, the safety knob364may be pushed along the slot368away from the third knob safety recess366, to enable manual rotation of the third knob232.

According to some embodiments, rotation of the third rotatable knob232in a first direction can be translated to rotation of the distal end threads242of each actuation shaft210about its longitudinal axes, enabling it to disengage from the prosthetic valve, while rotation of the third rotatable knob232in an opposite, second direction, is prevented, which advantageously can avoid damage that might otherwise result from over-tightening the distal end threads242due to accidental rotation of the third rotatable knob232in the wrong direction.

According to some embodiments, the handle202can also include a ratcheting mechanism that allows the third rotatable knob232to rotate in one direction but prevents its rotation in the opposite direction. Further details of the ratcheting mechanism as well as other components of the release mechanism are described in Provisional U.S. Application No. 62/990,299, which is incorporated by reference herein.

The delivery apparatus200can be retracted from the patient's body only after the actuation shafts210are completely disengaged from the respective rack members120. Otherwise, premature retraction of the delivery apparatus200(e.g., when the actuation shafts210are still engaged with the respective rack members120) may result in displacement of the prosthetic heart valve100itself. In certain embodiments, the decoupling between the prosthetic heart valve100and the actuation shafts210can be verified under fluoroscopy or using other X-ray imaging modalities. For example, a clinician may visually inspect certain relatively opaque structures of the prosthetic heart valve100and the delivery apparatus200to verify that the actuation shafts210are completely decoupled from the rack members120, e.g., by identifying a gap formed therebetween, or detecting spontaneous lateral movement of the distal ends of the actuation shafts210. However, such method of verification is subjective and may be inaccurate. Accordingly, it is desirable to provide an objective indication and accurate feedback of whether the actuation shafts210are completely disengaged from the rack members120of the prosthetic heart valve100.

FIGS.21-23show another embodiment of release mechanism222including or being coupled to a gear assembly432, which is configured to provide real-time feedback of engagement or disengagement between the actuation shafts210and the rack members120of the prosthetic heart valve100. Specifically, as described below, the release mechanism222can include or be operatively coupled to an indicator configured to provide an objective and accurate feedback of the engagement/disengagement status between the actuation shafts210and the prosthetic heart valve100. Although the release mechanism222and/or the gear assembly432are described below with respect to the delivery apparatus200and the prosthetic heart valve100, it should be noted that the principles disclosed herein can be used to verify and/or monitor the engagement/disengagement status of any implantable medical devices and the respective delivery apparatuses.

As shown, the gear assembly432can include an annular driver gear444and one or more pinion gears456(three pinion gears are shown). In the depicted embodiment, the pinion gears456are configured to directly contact and mesh with the driver gear444such that rotation of the driver gear444can cause corresponding rotation of the one or more pinion gears456. In other embodiments, the gear assembly432can also include one or more first idler gears (not shown), which are configured to mesh with the one or more pinion gears456and the driver gear444such that rotation of driver gear444can cause rotation of the one or more first idler gears, which in turn causes corresponding rotation of the one or more pinion gears456.

The gear assembly432can also include an indicator gear434. In the depicted embodiment, the indicator gear434is configured to directly contact and mesh with the driver gear444such that rotation of the driver gear444can cause corresponding rotation of the indicator gear434. In other embodiments, the gear assembly432can also include at least one second idler gear (not shown), which is configured to mesh with the indicator gear434and the driver gear444such that rotation of driver gear444can cause rotation of the second idler gear, which in turn causes corresponding rotation of the indicator gear434.

In some embodiments, the indicator gear434can have the same diameter as the one or more pinion gears456. In some embodiments, the indicator gear434can have a different diameter than the one or more pinion gears456. The number of teeth of the driver gear444to the number of teeth of a pinion gear456can define a first gear ratio. The number of teeth of the driver gear444to the number of teeth of the indicator gear434can define a second gear ratio. In some embodiments, the first gear ratio is the same as the second gear ratio such that one revolution of the driver gear444can cause the pinion gears456and the indicator gear434to have the same number of revolutions. In other embodiments, the first gear ratio is different than the second gear ratio such that one revolution of the driver gear444can cause the pinion gears456to have different number of revolutions (greater or less) than the indicator gear434.

In some embodiments, each pinion gear456can be connected to a proximal end portion of a corresponding actuation shaft210. Rotation of the pinion gear456can cause rotation of the corresponding actuation shaft such that a distal end portion (e.g., the thread242) of the actuation shaft210can be connected to or released from the rack member120of the prosthetic heart valve100. For example, each pinion gear456can have a pinion gear bore460, configured to receive a corresponding actuation shaft210therein. In some embodiments, the gear bore460can have a non-circular feature, such as a flat edge462, wherein the non-circular profile of the bore460matches a non-circular profile of a portion of the actuation shaft210extending therethrough. This non-circular profile allows the actuation shaft210to freely move axially in a proximal or a distal direction relative to the pinion gear456, for example, when actuating the expansion mechanism220of the handle202. Yet, as the pinion gear456is driven, for example by the driver gear444, the actuation shaft210can rotate therewith in the same direction.

According to certain embodiments, the indicator gear434can be operably connected to an indicator which is configured to indicate whether the one or more actuation shafts210are connected to or released from the prosthetic heart valve100. In the example embodiment described below, the indicator is an indicator tab252which is moveable between a first position and a second position relative to the housing228of the handle202such that when the indicator tab252is at the first position, the one or more actuation shafts210are connected to the prosthetic heart valve100, and when the indicator tab252is at the second position, the one or more actuation shafts210are released from the prosthetic heart valve100. In other embodiments, the indicator can be configured to provide other types of feedback to the user, such as in the form of audible sound, emitting light (e.g., via an LED), and/or tactile feedback, etc., to indicate whether the one or more actuation shafts210are connected to or released from the prosthetic heart valve100.

As shown inFIGS.21-23, the indicator gear434can be connected to a proximal end portion of an indicator shaft470, and rotation of the indicator gear434can cause rotation of the indicator shaft470about its axial axis. For example, the indicator gear434can have an indicator gear bore472configured to receive a proximal end portion of the indicator shaft470therein. In some embodiments, the portion of the indicator shaft470inside the gear bore472can be matingly coupled to the indicator gear434such that when the indicator gear434is driven, for example by the driver gear444, the indicator shaft470can rotate therewith in the same direction.

As shown inFIG.23, the indicator shaft470can be operably connected to an indicator tab252, which extends into a slot250on the housing228such that movement of the indicator tab252relative to the housing228can be visualized. For example, a distal end portion of the indicator shaft470can include external threads474, which can be threadably coupled to internal threads of a nut476. The nut476can be connected to the indicator tab252via an arm478extending between the nut476and the indicator tab252. As best shown inFIG.7, the tab252can be disposed in a slot250formed in the handle. The longitudinal sides of the slot prevent rotation of the tab252relative to the handle but allow sliding movement of the tab within the slot. Thus, rotation of the drive gear444drives rotation of the indicator gear434, producing rotation of the indicator shaft470. Since the tab252and the nut476are constrained against rotation by the dimensions of the slot250, rotation of the indicator shaft470produces axial movement of the nut476along the indicator shaft470, which causes corresponding axial movement of the indicator tab252relative to the housing228.

In other embodiments, the indicator tab252can be configured to move in a non-axial direction. For example, indicator tab252can be operably coupled to the distal end portion of the indicator shaft470via a gear member (not shown) such that the rotation of the indicator shaft470can be converted into circumferential movement of the indicator tab252. In yet further embodiments, the rotation of the indicator shaft470can be operatively coupled to other types of actuators that provide audial, visual, and/or tactile feedback to indicate the connection/release status between the actuation shafts210and the prosthetic heart valve100.

According to certain embodiments, the release mechanism222can include an annular knob (e.g., knob232) that is coupled to the driver gear444such that rotation of the knob in a clockwise or counterclockwise direction can cause rotation of the driver gear444in the same direction. In other embodiments, the release mechanism222can include an electric motor (not shown) coupled to the driver gear444such that actuation of the electric motor can cause rotation of the driver gear444. In some embodiments, the electric motor can be actuated by pressing a button, flip a switch, etc.

Thus, by actuating the release mechanism222(e.g., rotating the knob232), the driver gear444can be rotated in clockwise or counterclockwise direction, causing all pinion gears456and the indicator gear434to rotate simultaneously, together with the respective actuation shafts210and the indicator shaft470connected thereto. Rotating the actuation shafts210in a first angular direction (e.g., clockwise or counterclockwise) can cause the distal end portions of the actuation shafts210to be released from the respective rack members120, while simultaneously rotating the indicator shaft470can cause the indicator tab252to move in a first axial direction (e.g., proximally or distally). Conversely, rotating the actuation shafts210in a second angular direction opposite to the first angular direction can cause the distal end portions of the actuation shafts210to be coupled to the respective rack members120, while simultaneously rotating the indicator shaft470can cause the indicator tab252to move in a second axial direction opposite the first axial direction.

According to certain embodiments, the axial movement of the indicator tab252can be limited between a distal end254and a proximal end256of the slot250(see e.g.,FIG.7). In some embodiments, the housing228can have a plurality of graduation marks258or other indicia located adjacent to the slot250to indicate a precise location of the indictor tab252corresponding to a specific position of the actuation shafts between the connected and released states.

In some embodiments, the dimension of the slot250can be so configured that when the indicator tab252is moved to the distal end254, the actuation shafts210are connected to the prosthetic heart valve100, and when the indicator tab252is moved to the proximal end256, the actuation shafts210are released from the prosthetic heart valve100. Thus, as the release mechanism222is being actuated to release the shafts210from the prosthetic valve, the tab252moves in a proximal direction within the slot250. In an alternative embodiment, the tab252can be configured to move from the proximal end256toward the distal end254of the slot as the release mechanism222is being actuated.

In some embodiments, one of the graduation marks258(e.g., a mark located in a mid-point between the distal end254and the proximal end256) can be configured to mark a switch point. That is, when the indicator tab252is moved to the switch point, the distal end portions of the actuation shafts210are just about to be released from or connected to the respective rack members120of the prosthetic heart valve100. Thus, from the switch point, further moving the indicator tab252toward the proximal end256(or distal end254) can indicate the distal end portions of the actuation shafts210are moved further away (in a proximal direction) from the respective rack members120, whereas further moving the indicator tab252toward the distal end254(or proximal end256) can indicate the distal end portions of the actuation shafts210are threaded into (in a distal direction) the respective rack members120.

As described above, after the prosthetic heart valve100has been deployed at a target location using the delivery apparatus200, the prosthetic heart valve100can be radially expanded by actuating the expansion mechanism220on the handle202. Once expanded and secured, the prosthetic heart valve100can be released from the delivery apparatus200and then the delivery apparatus200can be retracted from the patient's body.

Specifically, the prosthetic heart valve100can be released from the delivery apparatus200by actuating the release mechanism222on the handle202. Actuation of the release mechanism222can activate the gear assembly432, which in turn can cause rotation of the actuation shafts210, thereby de-coupling the distal end portions of the actuation shafts210from the rack members120of the prosthetic heart valve100. Actuation of the release mechanism222can also cause simultaneous rotation of the indicator shaft470, thereby causing the indicator tab252to move axially along the slot250. Release of the actuation shafts210from the rack members120can be confirmed by the position of the indicator tab252(e.g., moving past the switch point). To ensure the actuation shafts210are completely disengaged from the respective rack members120, the release mechanism222can be further actuated until the indicator tab252is moved to a location (e.g., the proximal end256or distal end254) which indicates that the distal end portions of the actuation shafts210are sufficiently separated from the respective rack members120. Thus, the risk of displacing the prosthetic heart valve110during withdrawal of the delivery apparatus200can be reduced.

In view of the many possible embodiments to which the principles of the disclosure may be applied, it should be recognized that the illustrated embodiments are only examples and should not be taken as limiting the scope of the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Additional Examples of the Disclosed Technology

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.

Example 1. A delivery apparatus for implantation of a prosthetic heart valve, the delivery apparatus comprising: a handle housing; a release mechanism mounted on the handle housing; and a gear assembly comprising one or more pinion gears and an indicator gear; wherein actuation of the release mechanism causes rotation of the one or more pinion gears and the indicator gear; wherein each pinion gear is connected to a proximal end portion of a corresponding actuation shaft, wherein rotation of the pinion gear causes rotation of the corresponding actuation shaft such that a distal end portion of the actuation shaft can be connected to or released from the prosthetic heart valve; wherein the indicator gear is operably connected to an indicator tab, wherein rotation of the indicator gear causes the indicator tab to move between a first position and a second position relative to the handle housing such that when the indicator tab is at the first position, the one or more actuation shafts are connected to the prosthetic heart valve, and when the indicator tab is at the second position, the one or more actuation shafts are released from the prosthetic heart valve.

Example 2. The delivery apparatus of any example herein, particularly example 1, wherein the indicator gear is connected to a proximal end portion of an indicator shaft, wherein a distal end portion of the indicator shaft is connected to the indicator tab, wherein rotation of the indicator gear causes rotation of the indicator shaft about its axial axis.

Example 3. The delivery apparatus of any example herein, particularly example 2, wherein the indicator tab is connected to a nut threadably coupled to the distal end portion of the indicator shaft, wherein rotation of the indicator shaft causes axial movement of the nut relative to the indicator shaft.

Example 4. The delivery apparatus of any example herein, particularly any one of examples 1-3, wherein the indicator tab extends into a slot on the handle housing such that movement of the indicator tab relative to the handle housing can be visualized.

Example 5. The delivery apparatus of any example herein, particularly example 4, wherein the handle housing comprises a plurality of graduation marks adjacent to the slot to indicate a location of the indictor tab between the first and second positions.

Example 6. The delivery apparatus of any example herein, particularly any one of examples 1-5, wherein the gear assembly comprises a driver gear operably coupled to the one or more pinion gears and the indicator gear such that rotation of the driver gear causes corresponding rotation of the one or more pinion gears and the indicator gear.

Example 7. The delivery apparatus of any example herein, particularly example 6, wherein the release mechanism comprises a knob coupled to the driver gear such that rotation of the knob relative to the handle housing causes corresponding rotation of the driver gear.

Example 8. The delivery apparatus of any example herein, particularly any one of examples 6-7, wherein the gear assembly comprises one or more first idler gears configured to mesh with the one or more pinion gears and the driver gear such that rotation of driver gear causes rotation of the one or more first idler gears, which in turn causes corresponding rotation of the one or more pinion gears.

Example 9. The delivery apparatus of any example herein, particularly any one of examples 6-8, wherein the gear assembly comprises a second idler gear configured to mesh with the indicator gear and the driver gear such that rotation of the driver gear causes rotation of the second idler gear, which in turn causes corresponding rotation of the indicator gear.

Example 10. The delivery apparatus of any example herein, particularly any one of examples 1-9, wherein the indicator gear has the same diameter as the one or more pinion gears.

Example 11. The delivery apparatus of any example herein, particularly any one of examples 1-9, wherein the indicator gear has a different diameter than the one or more pinion gears.

Example 12. A delivery apparatus for implanting a prosthetic heart valve, comprising:

a handle; and one or more actuation shafts, each having a proximal end portion connected to the handle and a distal end portion that is releasably couplable to the prosthetic heart valve; wherein the handle comprises a housing and a release mechanism mounted on the housing, wherein actuation of the release mechanism can cause the distal end portion of the actuation shafts to be connected to or released from the prosthetic heart valve; wherein the handle further comprises an indicator tab configured to indicate whether the one or more actuation shafts are connected to or released from the prosthetic heart valve.

Example 13. The delivery apparatus of any example herein, particularly example 12, wherein the indicator tab is moveable between a first position and a second position relative to the housing such that when the indicator tab is at the first position, the one or more actuation shafts are connected to the prosthetic heart valve, and when the indicator tab is at the second position, the one or more actuation shafts are released from the prosthetic heart valve.

Example 14. The delivery apparatus of any example herein, particularly example 13, wherein the indicator tab extends into a slot on the housing such that movement of the indicator tab relative to the housing can be visualized.

Example 15. The delivery apparatus of any example herein, particularly any one of examples 13-14, wherein the housing comprises a plurality of graduation marks between the first and second positions to indicate a connection status between the one or more actuation shafts and the prosthetic heart valve.

Example 16. The delivery apparatus of any example herein, particularly any one of examples 12-15, wherein the handle further comprises a gear assembly having one or more pinion gears and an indicator gear, wherein actuation of the release mechanism causes rotation of the one or more pinion gears and the indicator gear.

Example 17. The delivery apparatus of any example herein, particularly example 16, wherein the gear assembly comprises a driver gear operably coupled to the one or more pinion gears and the indicator gear such that rotation of the driver gear causes corresponding rotation of the one or more pinion gears and the indicator gear.

Example 18. The delivery apparatus of any example herein, particularly example 17, wherein the release mechanism comprises a knob coupled to the driver gear such that rotation of the knob relative to the housing causes corresponding rotation of the driver gear.

Example 19. The delivery apparatus of any example herein, particularly any one of examples 16-18, wherein the gear assembly comprises one or more first idler gears configured to mesh with the one or more pinion gears and the driver gear such that rotation of driver gear causes rotation of the one or more first idler gears, which in turn causes corresponding rotation of the one or more pinion gears.

Example 20. The delivery apparatus of any example herein, particularly any one of examples 16-19, wherein the gear assembly comprises a second idler gear configured to mesh with the indicator gear and the driver gear such that rotation of the driver gear causes rotation of the second idler gear, which in turn causes corresponding rotation of the indicator gear.

Example 21. The delivery apparatus of any example herein, particularly any one of examples 16-20, wherein each pinion gear is connected to the proximal end portion of a corresponding actuation shaft, wherein rotation of the pinion gear causes rotation of the corresponding actuation shaft such that the distal end portion of the actuation shaft can be connected to or released from the prosthetic heart valve.

Example 22. The delivery apparatus of any example herein, particularly any one of examples 16-21, wherein the indicator gear is operably connected to the indicator tab, wherein rotation of the indicator gear causes the indicator tab to move between the first position and the second position relative to the housing.

Example 23. The delivery apparatus of any example herein, particularly any one of examples 16-22, wherein the indicator gear is connected to a proximal end portion of an indicator shaft, wherein a distal end portion of the indicator shaft is connected to the indicator tab, wherein rotation of the indicator gear causes rotation of the indicator shaft about its axial axis.

Example 24. The delivery apparatus of any example herein, particularly example 23, wherein the indicator tab is connected to a nut threadably coupled to the distal end portion of the indicator shaft, wherein rotation of the indicator shaft causes axial movement of the nut relative to the indicator shaft.

Example 25. The delivery apparatus of any example herein, particularly any one of examples 12-24, further comprising one or more support sleeves, wherein each actuation shaft extends through a lumen of a corresponding support sleeve, wherein the distal end portion of each actuation shaft and a distal end portion of the corresponding support sleeve are configured to interface with a corresponding actuator of the prosthetic heart valve.

Example 26. The delivery apparatus of any example herein, particularly example 25, wherein the handle further comprises an expansion mechanism mounted on the housing, wherein the expansion mechanism is connected to the proximal end portion of each actuation shaft and a proximal end portion of each support sleeve, wherein actuation of the expansion mechanism can cause axial movement of the one or more actuation shafts relative to the corresponding support sleeves so as to actuate the actuators of the prosthetic heart valve for radial expansion or compression of the prosthetic heart valve.

Example 27. The delivery apparatus of any example herein, particularly any one of examples 25-26, further comprising an intermediate shaft, wherein the one or more actuation shafts and the corresponding support sleeves extend through one or more lumens of the intermediate shaft.

Example 28. The delivery apparatus of any example herein, particularly example 27, further comprising an inner shaft and a nose cone connected to a distal end portion of the inner shaft, wherein the inner shaft extends through a nosecone lumen of the intermediate shaft.

Example 29. The delivery apparatus of any example herein, particularly example 28, wherein the handle further comprises a nosecone mechanism mounted on the housing, wherein a proximal end portion of the inner shaft is connected to the nosecone mechanism such that actuation of the nosecone mechanism can cause axial movement of the inner shaft relative to the intermediate shaft.

Example 30. The delivery apparatus of any example herein, particularly any one of examples 27-29, further comprising an outer shaft, wherein the intermediate shaft extends through a lumen of the outer shaft, wherein a distal end portion of the outer shaft is configured to retain the prosthetic heart valve in a radially compressed configuration.

Example 31. The delivery apparatus of any example herein, particularly example 30, wherein the handle further comprises a deployment mechanism mounted on the housing, wherein the deployment mechanism is coupled to a proximal end portion of the intermediate shaft and a proximal end portion of the outer shaft, wherein actuation of the deployment mechanism can result in relative axial movement between the intermediate shaft and the outer shaft so as to allow the distal end portion of the outer shaft to cover or expose the prosthetic heart valve.

Example 32. An assembly, comprising: a prosthetic heart valve having one or more actuators, wherein actuation of the actuators can cause radial expansion or compression of the prosthetic heart valve; and a delivery apparatus comprising a handle and one or more actuation shafts; wherein each actuation shaft comprises a proximal end portion connected to the handle and a distal end portion that is releasably couplable to a corresponding actuator; wherein the handle comprises a release mechanism, wherein actuation of the release mechanism can cause the distal end portion of the actuation shafts to be connected to or released from the corresponding actuators; wherein the handle further comprises an indicator tab configured to indicate whether the one or more actuation shafts are connected to or released from the corresponding actuators.

Example 33. The assembly of any example herein, particularly example 32, wherein the indicator tab is moveable between a first position and a second position spaced apart from each other such that when the indicator tab is at the first position, the one or more actuation shafts are connected to the corresponding actuators, and when the indicator tab is at the second position, the one or more actuation shafts are released from the corresponding actuators.

Example 34. The assembly of any example herein, particularly example 33, wherein the indicator tab extends into a slot on the handle such that movement of the indicator tab can be visualized.

Example 35. The assembly of any example herein, particularly any one of examples 33-34, wherein the handle comprises a plurality of graduation marks between the first and second positions to indicate a degree of connection or separation between the one or more actuation shafts and the corresponding actuators.

Example 36. The assembly of any example herein, particularly any one of examples 32-35, wherein the handle further comprises a gear assembly having one or more pinion gears and an indicator gear, wherein actuation of the release mechanism causes rotation of the one or more pinion gears and the indicator gear.

Example 37. The assembly of any example herein, particularly example 36, wherein the gear assembly comprises a driver gear operably coupled to the one or more pinion gears and the indicator gear such that rotation of the driver gear causes corresponding rotation of the one or more pinion gears and the indicator gear.

Example 38. The assembly of any example herein, particularly example 37, wherein the release mechanism comprises a knob coupled to the driver gear such that rotation of the knob about its central axis causes corresponding rotation of the driver gear.

Example 39. The assembly of any example herein, particularly any one of examples 36-38, wherein the gear assembly comprises one or more first idler gears configured to mesh with the one or more pinion gears and the driver gear such that rotation of driver gear causes rotation of the one or more first idler gears, which in turn causes corresponding rotation of the one or more pinion gears.

Example 40. The assembly of any example herein, particularly any one of examples 36-39, wherein the gear assembly comprises a second idler gear configured to mesh with the indicator gear and the driver gear such that rotation of the driver gear causes rotation of the second idler gear, which in turn causes corresponding rotation of the indicator gear.

Example 41. The assembly of any example herein, particularly any one of examples 36-40, wherein each pinion gear is connected to the proximal end portion of a corresponding actuation shaft, wherein rotation of the pinion gear causes rotation of the corresponding actuation shaft such that the distal end portion of the actuation shaft can be connected to or released from the corresponding actuator.

Example 42. The assembly of any example herein, particularly any one of examples 36-41, wherein the indicator gear is operably connected to the indicator tab, wherein rotation of the indicator gear causes the indicator tab to move between the first position and the second position.

Example 43. The assembly of any example herein, particularly any one of examples 36-42, wherein the indicator gear is connected to a proximal end portion of an indicator shaft, wherein a distal end portion of the indicator shaft is connected to the indicator tab, wherein rotation of the indicator gear causes rotation of the indicator shaft about its axial axis.

Example 44. The assembly of any example herein, particularly example 43, wherein the indicator tab is connected to a nut threadably coupled to the distal end portion of the indicator shaft, wherein rotation of the indicator shaft causes axial movement of the nut relative to the indicator shaft.

Example 45. The assembly of any example herein, particularly any one of examples 32-44, wherein each actuator comprises an inner member received at least partially within an outer member, wherein relative axial movement between the inner member and the outer member causes radial expansion or compression of the prosthetic heart valve.

Example 46. The assembly of any example herein, particularly example 45, wherein the delivery apparatus further comprises one or more support sleeves, wherein each actuation shaft extends through a lumen of a corresponding support sleeve, wherein the distal end portion of each actuation shaft is configured to be releasably connected to the inner member, and a distal end portion of the corresponding support sleeve is configured to be releasably connected to the outer member.

Example 47. The assembly of any example herein, particularly example 46, wherein the distal end portion of each actuation shaft is configured to threadably coupled to a proximal end portion of the inner member and the distal end portion of the corresponding support sleeve is configured to abut a proximal end portion of the outer member such that axial movement of the actuation shaft relative to the corresponding support sleeve causes axial movement of the inner member relative to the outer member.

Example 48. The assembly of any example herein, particularly any one of examples 46-47, wherein the handle further comprises an expansion mechanism connected to the proximal end portion of each actuation shaft and a proximal end portion of each support sleeve, wherein actuation of the expansion mechanism can cause axial movement of the one or more actuation shafts relative to the corresponding support sleeves.

Example 49. The assembly of any example herein, particularly any one of examples 46-48, wherein the delivery apparatus further comprises an intermediate shaft, wherein the one or more actuation shafts and the corresponding support sleeves extend through one or more lumens of the intermediate shaft.

Example 50. The assembly of any example herein, particularly example 49, wherein the delivery apparatus further comprises an inner shaft and a nose cone connected to a distal end portion of the inner shaft, wherein the inner shaft extends through a nosecone lumen of the intermediate shaft.

Example 51. The assembly of any example herein, particularly example 50, wherein the handle further comprises a nosecone mechanism connected to a proximal end portion of the inner shaft such that actuation of the nosecone mechanism can cause axial movement of the inner shaft relative to the intermediate shaft.

Example 52. The assembly of any example herein, particularly any one of examples 49-51, wherein the delivery apparatus further comprises an outer shaft, wherein the intermediate shaft extends through a lumen of the outer shaft, wherein a distal end portion of the outer shaft is configured to retain the prosthetic heart valve in a radially compressed configuration.

Example 53. The assembly of any example herein, particularly example 52, wherein the handle further comprises a deployment mechanism coupled to a proximal end portion of the intermediate shaft and a proximal end portion of the outer shaft, wherein actuation of the deployment mechanism can result in relative axial movement between the intermediate shaft and the outer shaft so as to allow the distal end portion of the outer shaft to cover or expose the prosthetic heart valve.

Example 54. A method for implanting a prosthetic heart valve, the method comprising:

deploying the prosthetic heart valve at a target location within a patient's body using a delivery apparatus, the delivery apparatus comprising a handle and at least one actuation shaft that is releasably couplable to an actuator of the prosthetic heart valve; radially expanding the prosthetic heart valve; releasing the actuation shaft from the actuator; and confirming release of the actuation shaft from the actuator based on an indicator on the handle.

Example 55. The method of any example herein, particularly example 54, wherein deploying the prosthetic heart valve comprises navigating an outer shaft of the delivery apparatus through a patient's vasculature until a distal end portion of the outer shaft reaches the target location, wherein the distal end portion of the outer shaft is configured to retain the prosthetic heart valve in a radially compressed configuration.

Example 56. The method of any example herein, particularly example 55, wherein deploying the prosthetic heart valve comprises actuating a deployment mechanism on the handle, wherein actuating the deployment mechanism causes axial movement of the outer shaft relative to the actuation shaft so as to expose the prosthetic heart valve.

Example 57. The method of any example herein, particularly any one of examples 54-56, wherein radially expanding the prosthetic heart valve comprises axially moving an inner member of the actuator relative to an outer member of the actuator in a first direction.

Example 58. The method of any example herein, particularly example 57, further comprising radially compressing the prosthetic heart valve by axially moving the inner member relative to the outer member in a second direction that is opposite to the first direction.

Example 59. The method of any example herein, particularly any one of examples 57-58, wherein radially expanding the prosthetic heart valve comprises coupling a distal end portion of the actuation shaft to the inner member and abutting a distal end portion of a support sleeve against a proximal end portion of the outer member such that axial movement of the actuation shaft relative to the support sleeve causes corresponding axial movement of the inner member relative to the outer member, wherein the actuation shaft extends through a lumen of the support sleeve.

Example 60. The method of any example herein, particularly example 59, wherein radially expanding the prosthetic heart valve comprises actuating an expansion mechanism on the handle, wherein actuating the expansion mechanism causes axial movement of the actuation shaft relative to the support sleeve.

Example 61. The method of any example herein, particularly any one of examples 54-60, wherein releasing the actuation shaft comprises rotating the actuation shaft so as to threadably uncoupling the actuation shaft from the actuator.

Example 62. The method of any example herein, particularly example 61, wherein rotating the actuation shaft comprises rotating a pinion gear in the handle, wherein the pinion gear is coupled to a proximal end portion of the actuation shaft.

Example 63. The method of any example herein, particularly any one of examples 54-62, wherein the indicator comprises an indicator tab that is visible on the handle, wherein confirming release of the actuation shaft comprises moving the indicator tab from a first position to a second position, wherein when the indicator tab is at the first position, the actuation shaft is connected to the actuator, and when the indicator tab is at the second position, the actuation shaft is released from the actuator.

Example 64. The method of any example herein, particularly example 63, wherein moving the indicator comprises rotating an indicator shaft in the handle, wherein the indicator tab is connected to a nut threadably coupled to a distal end portion of the indicator shaft such that rotation of the indicator shaft causes axial movement of the nut relative to the indicator shaft.

Example 65. The method of any example herein, particularly example 64, wherein rotating the indicator shaft comprises rotating an indicator gear in the handle, wherein the indicator gear is coupled to a proximal end portion of the indicator shaft.

Example 66. The method of any example herein, particularly any one of examples 62 and 65, wherein rotating the indicator gear comprises rotating a driver gear in the handle, wherein the driver gear is operatively coupled to both the pinion gear and the indicator gear.

Example 67. The method of any example herein, particularly example 66, wherein rotating the driver gear comprises actuating a release mechanism on the handle, wherein actuating the release mechanism causes rotation of the driver gear.

Example 68. A delivery apparatus for controlling implantation of a prosthetic heart valve, the delivery apparatus comprising: a handle housing; a release mechanism mounted on the handle housing, wherein the release mechanism is operably coupled to at least one actuation shaft, wherein actuation of the release mechanism can cause a distal end portion of the actuation shaft to be connected to or released from the prosthetic heart valve; and an indicator tab configured to indicate whether the actuation shaft if connected to or released from the prosthetic heart valve.

Example 69. The delivery apparatus of any example herein, particularly example 68, wherein the indicator tab is moveable between a first position and a second position, wherein the first and second positions are so configured that when the indicator tab is at the first position, the actuation shaft is connected to the prosthetic heart valve, and when the indicator tab is at the second position, the actuation shaft is released from the prosthetic heart valve.

Example 70. The delivery apparatus of any example herein, particularly example 69, wherein the indicator tab extends into a slot on the handle such that movement of the indicator tab is visible by an operator of the handle.

Example 71. The delivery apparatus of any example herein, particularly any one of examples 68-70, further comprising a gear assembly having at least one pinion gear and an indicator gear, wherein actuation of the release mechanism causes rotation of the pinion gear and the indicator gear.

Example 72. The delivery apparatus of any example herein, particularly example 71, wherein the gear assembly comprises a driver gear operably coupled to the pinion gear and the indicator gear such that rotation of the driver gear causes corresponding rotation of the pinion gear and the indicator gear.

Example 73. The delivery apparatus of any example herein, particularly example 72, wherein the release mechanism comprises a knob coupled to the driver gear such that rotation of the knob about its central axis causes corresponding rotation of the driver gear.

Example 74. The delivery apparatus of any example herein, particularly any one of examples 71-73, wherein the gear assembly comprises a first idler gear configured to mesh with the pinion gear and the driver gear such that the first idler gear can transmit the rotation of driver gear to the pinion gear.

Example 75. The delivery apparatus of any example herein, particularly any one of examples 71-74, wherein the gear assembly comprises a second idler gear configured to mesh with the indicator gear and the driver gear such that the second idler gear can transmit the rotation of the driver gear to the indicator gear.

Example 76. The delivery apparatus of any example herein, particularly any one of examples 71-75, wherein the pinion gear is connected to a proximal end portion of the actuation shaft, wherein rotation of the pinion gear causes rotation of the actuation shaft such that the distal end portion of the actuation shaft can be connected to or released from the prosthetic heart valve.

Example 77. The delivery apparatus of any example herein, particularly any one of examples 71-76, wherein the indicator gear is operably connected to the indicator tab, wherein rotation of the indicator gear causes the indicator tab to move between the first position and the second position.

Example 78. The delivery apparatus of any example herein, particularly any one of examples 71-77, wherein the indicator gear is connected to a proximal end portion of an indicator shaft, wherein a distal end portion of the indicator shaft is connected to the indicator tab, wherein rotation of the indicator gear causes rotation of the indicator shaft about its axial axis.

Example 79. The delivery apparatus of any example herein, particularly example 78, wherein the indicator tab is connected to a nut threadably coupled to the distal end portion of the indicator shaft, wherein rotation of the indicator shaft causes axial movement of the nut relative to the indicator shaft.

Example 80. A delivery apparatus for implanting a prosthetic heart valve, comprising: a handle having a release mechanism; and at least one actuation shaft connected to the handle, wherein the actuation shaft is configured to be releasably connected to the prosthetic heart valve and cause radial expansion or compression of the prosthetic heart valve; wherein actuation of the release mechanism can cause a distal end portion of the actuation shaft to be connected to or released from the prosthetic heart valve; wherein the release mechanism is operatively connected to an indicator which is configured to indicate whether the actuation shaft is connected to or released from the prosthetic heart valve.

Example 81. The delivery apparatus of any example herein, particularly example 80, wherein the indicator comprises an indicator tab that is moveable between a first position and a second position, wherein the first and second positions are so configured that when the indicator tab is at the first position, the actuation shaft is connected to the prosthetic heart valve, and when the indicator tab is at the second position, the actuation shaft is released from the prosthetic heart valve.

Example 82. The delivery apparatus of any example herein, particularly any one of examples 80-81, wherein the release mechanism is coupled to a gear assembly comprising at least one pinion gear and an indicator gear, wherein actuation of the release mechanism causes rotation of the pinion gear and the indicator gear.

Example 83. The delivery apparatus of any example herein, particularly example 82, wherein the gear assembly comprises a driver gear operably coupled to the pinion gear and the indicator gear such that rotation of the driver gear causes corresponding rotation of the pinion gear and the indicator gear.

Example 84. The delivery apparatus of any example herein, particularly example 83, wherein the release mechanism comprises a knob coupled to the driver gear such that rotation of the knob about its central axis causes corresponding rotation of the driver gear.

Example 85. The delivery apparatus of any example herein, particularly any one of examples 82-84, wherein the gear assembly comprises a first idler gear configured to mesh with the pinion gear and the driver gear such that the first idler gear can transmit the rotation of driver gear to the pinion gear.

Example 86. The delivery apparatus of any example herein, particularly any one of examples 82-85, wherein the gear assembly comprises a second idler gear configured to mesh with the indicator gear and the driver gear such that the second idler gear can transmit the rotation of the driver gear to the indicator gear.

Example 87. The delivery apparatus of any example herein, particularly any one of examples 82-86, wherein the pinion gear is connected to a proximal end portion of the actuation shaft, wherein rotation of the pinion gear causes rotation of the actuation shaft such that the distal end portion of the actuation shaft can be connected to or released from the prosthetic heart valve.

Example 88. The delivery apparatus of any example herein, particularly any one of examples 82-87, wherein the indicator gear is operably connected to the indicator tab, wherein rotation of the indicator gear causes the indicator tab to move between the first position and the second position.

Example 89. The delivery apparatus of any example herein, particularly any one of examples 82-88, wherein the indicator gear is connected to a proximal end portion of an indicator shaft, wherein a distal end portion of the indicator shaft is connected to the indicator tab, wherein rotation of the indicator gear causes rotation of the indicator shaft about its axial axis.

Example 90. The delivery apparatus of any example herein, particularly example 89, wherein the indicator tab is connected to a nut threadably coupled to the distal end portion of the indicator shaft, wherein rotation of the indicator shaft causes axial movement of the nut relative to the indicator shaft.

Example 91. The delivery apparatus of any example herein, particularly any one of examples 80-90, further comprising a support sleeve, wherein the actuation shaft extends through a lumen of a support sleeve, wherein the distal end portion of the actuation shaft and a distal end portion of the corresponding support sleeve are configured to interface with a corresponding actuator of the prosthetic heart valve.

Example 92. The delivery apparatus of any example herein, particularly example 91, wherein the handle further comprises an expansion mechanism connected to a proximal end portion of the actuation shaft and a proximal end portion of support sleeve, wherein actuation of the expansion mechanism can cause axial movement of the actuation shaft relative to the support sleeve so as to actuate the actuator of the prosthetic heart valve for radial expansion or compression of the prosthetic heart valve.

Example 93. The delivery apparatus of any example herein, particularly any one of examples 92-93, further comprising an intermediate shaft, wherein the actuation shaft and the support sleeve extend through a first lumen of the intermediate shaft.

Example 94. The delivery apparatus of any example herein, particularly example 93, further comprising an inner shaft and a nose cone connected to a distal end portion of the inner shaft, wherein the inner shaft extends through a second lumen of the intermediate shaft.

Example 95. The delivery apparatus of any example herein, particularly example 94, wherein the handle further comprises a nosecone mechanism connected to a proximal end portion of the inner shaft such that actuation of the nosecone mechanism can cause axial movement of the inner shaft relative to the intermediate shaft.

Example 96. The delivery apparatus of any example herein, particularly any one of examples 93-95, further comprising an outer shaft, wherein the intermediate shaft extends through a lumen of the outer shaft, wherein a distal end portion of the outer shaft is configured to retain the prosthetic heart valve in a radially compressed configuration.

Example 97. The delivery apparatus of any example herein, particularly example 96, wherein the handle further comprises a deployment mechanism coupled to a proximal end portion of the intermediate shaft and a proximal end portion of the outer shaft, wherein actuation of the deployment mechanism can result in relative axial movement between the intermediate shaft and the outer shaft so as to allow the distal end portion of the outer shaft to cover or expose the prosthetic heart valve.