WO2023177645A1

WO2023177645A1 - Self-expanding prosthetic heart valves and methods for controlled radial expansion

Info

Publication number: WO2023177645A1
Application number: PCT/US2023/015152
Authority: WO
Inventors: Ofir Witzman
Original assignee: Edwards Lifesciences Corporation
Priority date: 2022-03-15
Filing date: 2023-03-14
Publication date: 2023-09-21

Abstract

Prosthetic heart valves including an at least partially self-expandable annular frame and an outer skirt configured to enable step-wise radial expansion of the valve, as well as methods and delivery apparatus associated therewith, are disclosed. The outer skirt is attached to exterior surface of the frame, and includes axial sleeves that are parallel to a longitudinal axis of the frame. Each of the axial sleeves is configured to receive an expansion control member of a deliver apparatus. A resistive force is applied by the expansion control members on the prosthetic valve in a radially compressed configuration to limit radial expansion of the valve. Sequential withdrawal of each expansion control member from its respective axial sleeve releases of a corresponding portion of the outer skirt, and enables radial expansion of the valve to a diameter defined at least in part by the released portion of the outer skirt.

Description

SELF-EXPANDING PROSTHETIC HEART VALVES AND METHODS FOR CONTROLLED RADIAL EXPANSION

CROSS-REFERENCE TO RELATED APPLICATIONS

[001] This application claims the benefit of U.S. Provisional Patent Application No. 63/320,106, filed March 15, 2022, which is incorporated by reference herein in its entirety.

FIELD

[002] The present disclosure relates to prosthetic heart valves, including frames, an attached valve structure, and an outer skirt configured to control radial expansion of a prosthetic valve, as well as associated delivery apparatus and methods of implantation of a prosthetic valve including the outer skirt.

BACKGROUND

[003] 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 (for example, stents) and artificial valves, as well as a number of known methods of implanting these devices and valves in humans. Various surgical approaches (such as for example, percutaneous and minimally-invasive procedures or openheart procedures) are used to deliver prosthetic medical devices at locations inside the body.

[004] In one specific example of a minimally invasive implantation procedure, a prosthetic heart valve can be mounted in a crimped state on the distal end of a delivery device and advanced through the patient’ s vasculature (for example, through a femoral artery and the aorta) until the prosthetic valve reaches the implantation site in the heart. The prosthetic valve is then radially expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted, actuating a mechanical actuator that applies an expansion force to the prosthetic valve, or by deploying the prosthetic valve from the delivery device so that the prosthetic valve can self-expand. Once the prosthetic valve is fully expanded, it is then operational inside of the patient’ s heart and replaces the function of the native heart valve for the useful life of the prosthetic valve. [005] Most self-expandable, transcatheter heart valves comprise a radially expandable and compressible annular metal frame and prosthetic leaflets mounted inside the frame. The frame can comprise a plurality of circumferentially extending rows of angled struts defining rows of open cells of the frame. The prosthetic valve can include an outer sealing member (also referred to as an “outer skirt”) affixed to an outer surface of the frame for sealing the prosthetic valve against tissue of the native heart valve. The outer skirt typically is attached to frame via sutures. During implantation, a self-expandable heart valve can be disposed within a sheath of the delivery device that retains the valve in its crimped state during transcatheter delivery, and retraction of the sheath can allow the self-expandable heart valve to be released from the sheath and expand to its functional size.

[006] 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 and balloon-expandable heart valves can provide one or more advantages over self-expandable prosthetic heart valves. For example, after positioning at the desired implantation site, expansion of mechanically expandable prosthetic heart valves and balloon expandable heart valves can be selectively controlled to cause the valve to expand to various desired diameters and/or to achieve gradual expansion of the prosthetic valve. However, despite these benefits, mechanically expandable prosthetic heart valves and balloon-expandable heart valves can have one or more disadvantages relative to selfexpandable valves, such as requiring complex actuator systems, which can increase the cost of the delivery system and the complexity of the implantation procedure.

[007] Accordingly, a self-expandable prosthetic heart valve having a mechanism that can facilitate controllable radial expansion thereof is desired.

SUMMARY

[008] Described herein are prosthetic heart valves, delivery apparatus, and methods for radially expanding and/or implanting prosthetic heart valves. The disclosed prosthetic heart valves, delivery apparatus, and methods can, for example, provide or enable gradual or step- wise or controlled radial expansion of a prosthetic heart valve. As such, the devices and methods disclosed herein can, among other things, overcome one or more of the deficiencies of known prosthetic heart valves and their delivery apparatus.

[009] Specifically, described herein are examples of prosthetic heart valves including an at least partially self-expandable annular frame comprising a plurality of interconnected struts. The prosthetic heart valve can further include a leaflet assembly (that is, a valvular structure) secured to an interior of the frame and an outer skirt secured to an exterior of the frame. In some examples, the outer skirt can be configured to enable gradual or step- wise or controlled radial expansion of the prosthetic valve. Additionally, described herein are delivery apparatus configured for use with the prosthetic valves, as well as methods associated with the prosthetic valves and delivery apparatus.

[010] A prosthetic heart valve can comprise a frame and a valvular structure coupled to the frame. In addition to these components, a prosthetic heart valve can further comprise one or more of the components disclosed herein.

[Oil] In some examples, a prosthetic heart valve can be at least partially self-expandable and can include an outer skirt having a plurality of retaining elements.

[012] In some examples, the plurality of retaining element are a plurality of axial sleeves.

[013] In some examples, the prosthetic valve can be fully self-expandable.

[014] In some examples, the prosthetic valve can be partially self-expandable and further includes a mechanical actuator for transitioning the prosthetic valve from a partially radially expanded state to a fully radially expanded state.

[015] In some examples, the outer skirt is attached to an outer surface of the frame of the prosthetic valve.

[016] In some examples, a circumference of the outer skirt corresponds to a circumference of the frame when the prosthetic valve is in a fully radially expanded state.

[017] In some examples, the outer skirt having a plurality of axial sleeves can include a cylindrical main body configured to be attached to an outer surface of a frame of the prosthetic heart valve.

[018] In some examples, an outer skirt having a plurality of axial sleeves can have a configuration where the plurality of axial sleeves are disposed on a surface of a cylindrical main body, such that they are disposed on an exterior surface of the prosthetic heart valve when the fabric body is attached to an outer surface of the frame.

[019] In some examples, the prosthetic valve is configured for use with a delivery apparatus including a plurality of expansion control members.

[020] In some examples, the outer skirt having a plurality of axial sleeves can be configured to enable receive at least one expansion control member through each of the axial sleeves.

[021] In some examples, the outer skirt having a plurality of axial sleeves can be configured to enable step-wise radial expansion of the prosthetic heart valve via successive withdrawal of each of expansion control members from the respective axial sleeves.

[022] In some examples, an outer skirt having a plurality of axial sleeves can be configured to enable gradual transition from the radially compressed state toward the radially expanded state via successive withdrawal of the expansion control members from the respective axial sleeves.

[023] In some examples, the axial sleeves can have an even distribution on a circumference of the outer skirt.

[024] In some examples, the axial sleeves can have an uneven distribution on a circumference of the outer skirt.

[025] In some examples, the axial sleeves can be distributed such that a first distance is defined between a first one of the axial sleeves and a second one of the axial sleeves, and a second distance is defined between the first one of the axial sleeves and a third one of the axial sleeves, wherein the first and second distances are each less than distances between other adjacent ones of the axial sleeves.

10261 In some examples, a sum of the first distance and the second distance can be about equal to distances between other adjacent ones of the axial sleeves.

[027] In some examples, the axial sleeves can be formed by a fold in a material of the outer skirt that is secured by an attachment line.

[028] In some examples, the axial sleeves can be tubular bodies attached to a cylindrical main body of the outer skirt. [029] In some examples, the axial sleeves can be parallel to a longitudinal axis of the prosthetic valve.

[030] In some examples, the prosthetic heart valve comprises one or more of the components recited in Examples 1-56 and 70-90 below.

[031] An assembly can comprise a prosthetic heart valve and a delivery apparatus.

[032] hr some examples, a prosthetic heart valve can include an at least partially selfexpandable frame and an outer skirt comprising a plurality of axial sleeves.

[033] In some examples, a delivery apparatus can include a plurality of expansion control members, a retaining member for releasably retaining distal portions of the expansion control members, and a delivery shaft having proximal portions of the expansion control members extending therein.

[034] In some examples, each of the axial sleeves can be configured to receive one or more the expansion control members therethrough.

[035] In some examples, the expansion control members can be configured to retain the prosthetic valve in a radially compressed state when the distal portions thereof are retained within the retaining member.

[036] In some examples, the expansion control members can be configured to limit radial expansion of the prosthetic valve when the distal portions thereof are retained within the retaining member.

[037] In some examples, the expansion control members can be configured for step-wise transitioning of the prosthetic heart valve from the radially compressed configuration toward the radially expanded configuration.

[038] In some examples, the expansion control members can be configured to be sequentially released from the distal member and withdrawn through respective axial sleeves.

[039] In some examples, the prosthetic heart valve and the delivery apparatus can be configured such that withdrawal of the expansion control members from the axial sleeves causes release of a respective portion of the outer skirt and results in the at least partially selfexpandable annular frame radially expanding to a diameter defined at least in part by the released portion of the outer skirt. [040] In some examples, the expansion control members can include control wires configured to be inserted into apertures of the retaining member.

[041] In some examples, the apertures can be disposed on a proximal face of the retaining member and a distal end of each of the apertures can be closed to limit movement of the control wires in a proximal to distal direction.

[042] In some examples, the expansion control members can include control tethers configured to be looped through apertures of the retaining member.

[043] In some examples, the delivery apparatus can include a handle coupled to the delivery shaft, the handle comprising one or more actuators, wherein at least one of the actuators is configured to retract a proximal portion of an expansion control member for withdrawal of the expansion control member from a respective one of the axial sleeves.

[044] In some examples, the assembly comprises one or more of the components recited in Examples 1-91 below.

[045] A delivery apparatus comprises a delivery shaft and a handle.

[046] In some examples, the delivery apparatus can include a plurality of expansion control members.

[047] In some examples, the delivery apparatus can be configured for step- wise controlled radial expansion of a prosthetic valve including an outer skirt having a plurality of axial sleeves, each of axial sleeves configured to receive at least one of the expansion control members therethrough.

[048] In some examples, the delivery apparatus can include a retaining member for releasably retaining distal portions of the expansion control members.

[049] In some examples, proximal portions of the expansion control members can extend into the delivery shaft.

[050] In some examples, the expansion control members include control wires configured to be inserted into apertures of the retaining member. [051] In some examples, the apertures can be disposed on a proximal face of the retaining member and a distal end of each of the apertures can be closed to limit movement of the control wires in a proximal to distal direction.

[052] In some examples, the expansion control members can include control tethers configured to be looped through apertures of the retaining member, the apertures including openings on the proximal and distal face of the retaining member.

[053] In some examples, the handle includes one or more actuators, wherein at least one of the actuators can be configured to apply a pulling force on a proximal portion of a control member to cause retraction of the control member in a distal to proximal direction.

[054] In some examples, the delivery apparatus comprises one or more of the components recited in Examples 31-91 below.

[055] A method of radially expanding a prosthetic valve from a radially compressed state to a radially expanded state can include positioning the prosthetic valve at or adjacent a implantation site within a patient’ s body while the prosthetic valve is in a radially compressed state.

[056] In some examples, radial expansion of the prosthetic valve in the radially compressed state is limited by a plurality of expansion control members inserted through a plurality of axial sleeves of an outer skirt on an outer surface of the prosthetic valve.

[057] In some examples, the method includes sequentially withdrawing each of the plurality of expansion control members from the axial sleeves to release corresponding portions of the outer skirt, resulting in radial expansion of the prosthetic valve to progressively larger diameters.

[058] In some examples, the method comprises one or more of the acts recited in Examples 70-78 below.

[059] In one representative example, a prosthetic heart valve configured to be transitioned between a radially compressed state and a radially expanded state is disclosed. The prosthetic heart valve includes: an annular frame, the annular frame being an at least partially self-expanding frame that is biased toward the radially expanded state of the prosthetic heart valve; and an outer skirt disposed on an outer surface of the annular frame. The outer skirt comprises a plurality of axial sleeves, wherein each of the plurality of axial sleeves is configured to receive a respective expansion control member of a plurality of expansion control members of a delivery apparatus therein. Further, the plurality of axial sleeves are configured such that, when the plurality of expansion control members are received within the plurality of axial sleeves, the plurality of expansion control members limit radial expansion of the annular frame; and wherein the outer skirt is configured to enable transition of the prosthetic valve from the radially compressed state toward the radially expanded state via withdrawal of the respective expansion control members from the plurality of axial sleeves.

[060] In another representative example, a prosthetic heart valve delivery system is disclosed. The prosthetic heart valve delivery system includes: (i) a prosthetic heart valve configured to transition between a radially compressed configuration and a radially expanded configuration, the prosthetic heart valve including: an at least partially self-expandable annular frame; and an outer skirt disposed on an outer surface of the frame, wherein the outer skirt comprises a plurality of axial sleeves disposed on an outer surface thereof; and (ii) a delivery apparatus including: a plurality of expansion control members, wherein each of the plurality of axial sleeves is configured to receive at least one expansion control member therethrough; a retaining member configured to releasably retain a distal portion of each of the plurality of expansion control members; and a delivery shaft configured to have at least a proximal portion of each of the plurality of expansion control members extend therein. The prosthetic heart valve and the delivery apparatus are configured such that, when the plurality of expansion control members are extended through the plurality of axial sleeves, the distal portions of the plurality of expansion control members are retained by the distal member, and the proximal portions of each of the plurality of expansion control members extend into the delivery apparatus, the plurality of expansion control members limit radial expansion of the frame.

[061] In another representative example, a delivery apparatus configured for step-wise transitioning of a prosthetic heart valve from a radially compressed configuration to a radially expanded configuration is disclosed. The prosthetic heart valve includes an at least partially self-expandable annular frame, and an outer skirt disposed on an outer surface of the frame and comprising a plurality of axial sleeves. The delivery apparatus includes: a plurality of expansion control members, wherein each of the plurality of expansion control members is configured to extend through one of the plurality of axial sleeves; a retaining member configured to releasably retain a distal portion of each of the plurality of expansion control members; and a delivery shaft configured to have at least a proximal portion of each of the plurality of expansion control members extend therein. The delivery apparatus is configured such that, when the plurality of expansion control members are extended through the plurality of axial sleeves, the distal portions of the plurality of expansion control members are retained by the distal member, and a proximal portion of each of the plurality of expansion control members extends into the delivery apparatus, the plurality of expansion control members limit radial expansion of the frame. Further, the delivery apparatus is configured for step- wise transitioning of the prosthetic heart valve from the radially compressed configuration toward the radially expanded configuration via successive withdrawal of each of the plurality of expansion control members from respective ones of the plurality of axial sleeves.

[062] In another representative example, a method for implanting a prosthetic heart valve is disclosed. The prosthetic heart valve comprising an at least partially self-expandable frame and an outer skirt disposed on an exterior surface of the frame, the outer skirt comprising a plurality of axial sleeves. The method includes: introducing a distal end portion of a delivery apparatus into a patient’s vasculature, wherein the prosthetic heart valve is retained in a radially compressed configuration within a delivery capsule of the distal end portion of the delivery apparatus, wherein the outer skirt has at least one of a plurality of expansion control members of the delivery apparatus inserted through each of the plurality of axial sleeves, wherein a distal portion of each of the plurality of expansion control members is releasably coupled to a retaining member that is distal relative to the prosthetic heart valve, wherein the prosthetic heart valve has an initial diameter in the radially compressed configuration; advancing the distal end portion of the delivery apparatus and the prosthetic heart valve through the vasculature toward an implantation site; deploying the prosthetic heart valve from the delivery capsule; and after deploying the prosthetic heart valve from the delivery capsule, limiting radial expansion the prosthetic heart valve by maintaining a position of each of the plurality of expansion control members within the respective axial sleeves.

[063] In another representative example, a method of gradually radially expanding an at least partially self-expandable prosthetic valve is disclosed. The method includes: positioning the prosthetic valve at a desired location within a patient’ s body while the prosthetic valve is an a radially compressed state, wherein radial expansion of the prosthetic valve in the radially compressed state is limited by a plurality of expansion control members inserted through a plurality of axial sleeves on an outer surface of the prosthetic valve; and sequentially withdrawing each of the plurality of expansion control members to release a corresponding portion of the prosthetic valve and cause radial expansion of the valve to progressively larger diameters until the prosthetic valve reaches a maximum radially selfexpanded state.

[064] In yet another representative example, a method of preparing an at least partially self-expandable prosthetic valve for implantation is disclosed. The method includes: radially compressing the prosthetic valve from a radially expanded state to a radially compressed state; maintaining the prosthetic valve in the radially compressed state, the maintain comprising applying a resistive force on the prosthetic valve via a plurality of expansion control members inserted through a plurality of axial sleeves on an outer surface of the prosthetic valve.

[065] In still another representative example, an outer skirt for an at least partially selfexpandable prosthetic heart valve is disclosed. The outer skirt includes: a fabric body configured to have a cylindrical configuration and to be attached to an outer surface of a frame of the prosthetic heart valve; a plurality of axial sleeves disposed on a surface of the fabric body and configured to be disposed on an exterior surface of the prosthetic heart valve when the fabric body is attached to the outer surface of the frame; wherein the plurality of axial sleeves are configured to receive a plurality of expansion control members of a delivery apparatus therethrough; and wherein the outer skirt is configured to enable step-wise radial expansion of the prosthetic heart valve via successive withdrawal of each of the plurality of expansion control members from the respective axial sleeves.

[066] The above method(s) can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (for example, with body parts, heart, tissue, etc. being simulated).

[067] 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 disclosed technology will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.

BRIEF DESCRIPTION OF THE DRAWINGS

[068] FIG. 1A is a perspective view of one example of a prosthetic valve including a frame and a plurality of leaflets attached to the frame.

[069] FIG. IB is a perspective view of the prosthetic valve of FIG. 1 A with an outer skirt disposed on an exterior of the frame.

[070] FIG. 2 is a side elevation view of a delivery assembly for a prosthetic heart valve.

[071] FIG. 3 is a perspective view of another example of a prosthetic heart valve including a frame and an outer skirt including a plurality of axial sleeves disposed on an exterior surface thereof, according to the present disclosure.

[072] FIGS. 4A and 4B are schematic illustrations of the outer skirt of the prosthetic heart valve illustrated in FIG. 3.

[073] FIGS. 5A-5E are side elevation views of the prosthetic heart valve of FIG. 3 and an exemplary delivery apparatus, illustrating an exemplary method of step-wise expansion of the prosthetic heart valve.

[074] FIG. 6 is a top plan view of a retaining member for the delivery apparatus shown in FIGS. 5A-5E.

[075] FIG. 7 is a perspective view of the prosthetic heart valve of FIG. 3 including another exemplary outer skirt and associated delivery apparatus.

[076] FIG. 8 is a perspective view of the prosthetic heart valve of FIG. 3 including yet another exemplary outer skirt and associated delivery apparatus. DETAILED DESCRIPTION

General Considerations

[077] For purposes of this description, certain aspects, advantages, and novel features of the examples of this disclosure are described herein. The described methods, systems, and apparatus should not be construed as limiting in any way. Instead, the present disclosure is directed toward all novel and non-obvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another. The disclosed methods, systems, and apparatus are not limited to any specific aspect, feature, or combination thereof, nor do the disclosed methods, systems, and apparatus require that any one or more specific advantages be present, or problems be solved.

[078] Features, integers, characteristics, compounds, materials, chemical moieties, or groups described in conjunction with a particular aspect, embodiment or example of the disclosure are to be understood to be applicable to any other aspect, embodiment or example described herein unless incompatible therewith. All of the features disclosed in this specification (including any accompanying claims, abstract, and drawings), and/or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features and/or steps are mutually exclusive. The disclosure is not restricted to the details of any foregoing examples. The disclosure extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, abstract, and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed.

[079] Although the operations of some of the disclosed examples are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like “provide” or “achieve” to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.

[080] As used herein, the terms “a,” “an,” and “at least one” encompass one or more of the specified element. That is, if two of a particular element are present, one of these elements is also present and thus “an” element is present. The terms “a plurality of’ and “plural” mean two or more of the specified element.

[081] As used herein, the term “and/or” used between the last two of a list of elements means any one or more of the listed elements. For example, the phrase “A, B, and/or C” means “A,” “B,” “C,” “A and B,” “A and C,” “B and C ,” or “A, B, and C.” Further as used herein, “and/or” means “and” or “or,” as well as “and” and “or.”

[082] As used herein, the term “coupled” generally means physically coupled or linked and does not exclude the presence of intermediate elements between the coupled items absent specific contrary language.

[083] Directions and other relative references (for example, 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 examples. 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.

[084] As used herein, with reference to the prosthetic heart valve and the delivery apparatus, “proximal” refers to a position, direction, or portion of a component that is closer to the user and/or a handle of the delivery apparatus that is outside the patient, while “distal” refers to a position, direction, or portion of a component that is further away from the user and/or the handle of the delivery apparatus 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 (for example, 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 (for example, 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. Further, the term “radial” refers to a direction that is arranged perpendicular to the axis and points along a radius from a center of an object (where the axis is positioned at the center, such as the longitudinal axis of the prosthetic valve).

Overview of the Disclosed Technology

[085] Prosthetic valves disclosed herein can be radially compressible and expandable between a radially compressed state and a radially expanded state. Thus, the prosthetic valves can be crimped on or retained by an implant delivery apparatus in the radially compressed state while being advanced through a patient’s vasculature on a delivery apparatus. The prosthetic valves can be expanded to the radially expanded state once the prosthetic valve reaches the implantation site. It is understood that the prosthetic valves disclosed herein may be used with a variety of implant delivery apparatuses and can be implanted via various delivery procedures, examples of which will be discussed in more detail later.

[086] Also described herein are examples of delivery apparatuses that can be used to navigate a subject’s vasculature to deliver an implantable, expandable medical device (for example, a prosthetic heart valve), tools, agents, or other therapy to a location within the body of a subject. Examples of procedures in which the delivery apparatuses are useful include neurological, urological, gynecological, fertility (for example, in vitro fertilization, artificial insemination), laparoscopic, arthroscopic, transesophageal, transvaginal, transvesical, transrectal, and procedures including access in any body duct or cavity. Particular examples include placing implants, including stents, grafts, embolic coils, and the like; positioning imaging devices and/or components thereof, including ultrasound transducers; and positioning energy sources, for example, for performing lithotripsy, RF sources, ultrasound emitters, electromagnetic sources, laser sources, thermal sources, and the like.

[087] FIGS. 1A and IB illustrate an exemplary prosthetic device (for example, prosthetic heart valve) that can be advanced through a patient’s vasculature, such as to a native heart valve, by a delivery apparatus. The frame of the prosthetic heart valve can be comprised of a shape-memory material (for example, Nitinol), and can be self-expandable for transition from the radially compressed state to the radially expanded state.

[088] As discussed above, self-expandable prosthetic heart valves have advantages over mechanically-expandable and balloon-expandable heart valves in that they do not require a separate mechanical actuator system to transition from a crimped state to a radially expanded state. For example, after transcatheter delivery of a conventional self-expandable prosthetic valve in a crimped state to a patient’ s native heart valve, a sheath of the delivery apparatus can be partially retracted and (initially) a first end portion of the prosthetic valve (for example, an inflow end portion) is released from the sheath and can be partially expanded. As the sheath is further retracted, an intermediate portion of the prosthetic valve is released and partially expanded, while the first end portion of the prosthetic valve is moved into a further expanded state (for example, an almost fully expanded state or a fully expanded state). Finally, a second end portion of the prosthetic valve (for example, an outflow end portion) is released from the sheath as the sheath is further retracted, thereby resulting in full radial expansion of all portions of the prosthetic valve and disengagement of the prosthetic valve from the delivery apparatus.

[089] In some examples, retraction of the sheath may cause the prosthetic valve to move distally or proximally relative to the native valve, and repositioning of the prosthetic valve may be required as it is progressively exposed from the sheath. Such repositioning can become increasingly difficult for the surgeon to perform and/or potentially dangerous to the patient as additional sections of the prosthetic valve are exposed from the sheath and expanded. Further, although expansion can be controlled at least in part via controlling an extent of retraction of the sheath, conventional self-expandable prosthetic heart valves lack a mechanism for precisely controlling a degree of radial expansion and/or enabling gradual radial expansion of the prosthetic valve. Furthermore, conventional self-expandable prosthetic heart valves lack a mechanism for enabling concurrent radial expansion of multiple or all portions of the valve (for example, concurrent radial expansion of the inflow end, the intermediate portion, and the outflow end).

[090] Thus, there is a need for self-expandable prosthetic heart valves that enable controllable and/or gradual expansion of the prosthetic valve. Further, there is a need for self-expandable prosthetic heart valves that limit distal and/or proximal movement of the valve after positioning of the prosthetic valve at the desired implantation site and during the radial expansion thereof. Yet further, there is a need for self-expandable prosthetic heart valves that enable concurrent radial expansion of inflow, intermediate, and outflow portions of the prosthetic valve.

[091 ] Described herein are examples of prosthetic heart valves configured for transcatheter implantation. The prosthetic heart valves can include an annular frame, a plurality of leaflets (that is, valvular structure) attached at an interior of the frame, and an outer skirt attached to an exterior of the frame. The prosthetic valve can optionally include an inner skirt attached at an interior of the frame. In some examples, the leaflets can be attached to the frame via commissures formed by joining pairs of adjacent ends (for example, commissure tabs) of the leaflets. The cusp edges of the leaflets can be attached to the outer skirt, the inner skirt mounted to an inner surface of the frame, and/or directly to selected struts of the frame.

[092] In some examples, the frame is a self-expandable frame that is biased toward a radially expanded configuration of the prosthetic valve, but can be selectively radially compressed or radially expanded to transition the prosthetic heart valve between the compressed configuration and the expanded configuration. In some examples, the frame can be a partially self-expandable frame that is configured to radially expand the prosthetic valve to a partially expanded state. In such examples, the prosthetic valve can include an additional mechanical actuation mechanism for transitioning the prosthetic valve to the fully radially expanded state. In the foregoing examples, the prosthetic heart valve can be radially compressed into the compressed configuration and retained in the compressed configuration for transcatheter delivery of the prosthetic heart valve to a target location. After delivery of the prosthetic heart valve to the target location, the radially compressed valve can be transitioned to the radially expanded configuration.

[093] In some examples disclosed herein, an outer skirt on the prosthetic valve (and a delivery apparatus configured for use with the prosthetic valve) can be configured to enable gradual or step-wise radial expansion of prosthetic heart valve. In some examples, the outer skirt can have an overall tubular or cylindrical shaped main body with a total circumferential length and a total diameter respectively corresponding to a circumference and a diameter of the annular frame when in the radially expanded configuration. Further, the outer skirt can include a plurality of retaining elements comprising axial sleeves (or loops, tubes, eyelets, rings, and/or other configurations of retaining elements) that are spaced around the circumference of the outer skirt, such as being evenly or unevenly spaced or distributed on an exterior surface of the outer skirt. Yet further, each of the axial sleeves can be configured to receive one or more expansion control members (also referred to as “control elements” or “release members”) (for example, wires, threads, and/or other forms of filaments) therethrough.

[094] The expansion control members can be components of a delivery apparatus or delivery system, and can be configured to control the gradual or step-wise radial expansion of the prosthetic heart valve from the radially compressed configuration to the radially expanded configuration. For example, in the radially compressed configuration of the prosthetic valve, each of the axial sleeves can have one or more expansion control members extended therethrough, and the radially compressed valve can be disposed between a distal member (for example, a nose cone of the delivery apparatus, or a retaining member disposed between the nose cone and prosthetic valve) and a distal end of a delivery shaft to position the prosthetic valve for radial expansion.

[095] In some examples, the expansion control members can be control wires comprised of a sufficiently rigid material and/or having a sufficient thickness to resist the biasing force of the self-expandable frame and retain the prosthetic valve in the radially compressed configuration when the wires are disposed through respective ones of the axial sleeves of the outer skirt. In this example, a distal tip or end of each control wire can be releasably attached to or retained within an aperture in the distal member, a distal portion of each control wire can extend through one of the axial sleeves of the outer skirt, and a proximal portion of each control wire can extend through a lumen of the delivery shaft.

[096] In some examples, the expansion control members can be control tethers or tethers comprised of a thinner and/or more flexible material relative to the control wires. The control tethers can comprise, for example, sutures, yams, or cables. In some examples, the control tethers can be looped though an aperture of the distal member such that leading and trailing end portions of the control tether pass through the respective axial sleeves. For example, the trailing end portion of each control tether can extend through an axial sleeve to an aperture in the distal member, an intermediate portion can extend through the aperture, and the leading end portion can extend from the aperture over an exterior edge of the distal member and back through the same axial sleeve. Further, each of the leading end portion and the trailing end portion can extend through a lumen of the delivery shaft. The radially compressed prosthetic valve can be disposed between distal member and a distal end of the delivery shaft to position to the prosthetic valve for radial expansion. In this example, the more flexible control tethers can be retained at a sufficient tautness to overcome the biasing force of the self-expandable frame, and thereby enable the control wires to maintain the prosthetic heart valve in the radially compressed configuration.

[097] After delivery of the radially compressed prosthetic valve to the target location and positioning thereof distal to the delivery shaft, the expansion control members can be withdrawn in a distal to proximal direction to free the expansion control members from attachment to the distal member and to remove the expansion control member from the respective axial sleeves of the outer skirt. In some examples, when the expansion control member is withdrawn, a section or portion of the outer skirt is freed or released and the selfexpandable frame can then radially expand to a diameter that is (at least in part) defined by the length of the freed section of the outer skirt. In some examples, each of the expansion control members can be individually or successively withdrawn in a step-wise manner to gradually (or step-wise) release additional sections of the outer skirt and to control a diameter or a degree of radial expansion of the self-expandable frame.

[098] In some examples, the axial sleeves are evenly spaced or distributed along the circumference of the outer skirt such that each withdrawn expansion control member releases a substantially equal length section of the outer skirt. In other examples, the axial sleeves are unevenly spaced or distributed along the circumference of the outer skirt such that withdraw of a specified expansion control member releases a section of the outer skirt of a different length relative to one or more others of the expansion control members such that the amount of radial expansion can vary depending on which expansion control member is successively withdrawn from the outer skirt. For example, it may be advantageous to release a smaller section of the outer skirt at a first step so that the prosthetic valve is radially expanded to a relatively smaller partially expanded state that enables the position thereof to be adjusted prior to releasing additional sections of the outer skirt and further expanding the valve. In some examples, it may be advantageous to release smaller sections of the skirt at the last steps of radial expansion for finer control of radial expansion when repositioning of the valve is limited.

[099] In some examples, a surgeon can easily control the degree of radial expansion of the self-expanding prosthetic valve by selective withdrawal of the expansion control members from respective axial sleeves, thereby resulting in user-controlled gradual or step-wise radial expansion of a self-expanding prosthetic heart valve. Further, the expansion control member mechanism can enable the prosthetic valve to be gradually or step-wise radially expanded along its entire length simultaneously (for example, concurrently expanded at the inflow end portion, the intermediate portion, and the outflow end portion), rather than successively expanding first a first end of the valve, then an intermediate portion of the valve, and finally a second end of the valve, as in conventional self-expanding valve delivery systems. Furthermore, the prosthetic valves and delivery systems disclosed herein may allow finer control of radial expansion and improved axial adjustability or positioning during implantation of the prosthetic heart valves relative to conventional self-expanding valve delivery systems.

Examples of the Disclosed Technology

[0100] FIGS. 1 A and IB show an exemplary prosthetic valve 100, according to one example. Any of the prosthetic valves disclosed herein are adapted to be implanted in the native aortic annulus, although in some examples they can be adapted to be implanted in the other native annuluses of the heart (the pulmonary, mitral, and tricuspid valves). The disclosed prosthetic valves also can be implanted within vessels communicating with the heart, including a pulmonary artery (for replacing the function of a diseased pulmonary valve, or the superior vena cava or the inferior vena cava (for replacing the function of a diseased tricuspid valve) or various other veins, arteries and vessels of a patient. The disclosed prosthetic valves also can be implanted within a previously implanted prosthetic valve (which can be a prosthetic surgical valve or a prosthetic transcatheter heart valve) in a valve-in-valve procedure.

[0101] In some examples, the disclosed prosthetic valves can be implanted within a docking or anchoring device that is implanted within a native heart valve or a vessel. For example, in one example, the disclosed prosthetic valves can be implanted within a docking device implanted within the pulmonary artery for replacing the function of a diseased pulmonary valve, such as disclosed in U.S. Publication No. 2017/0231756, which is incorporated by reference herein. In some example, the disclosed prosthetic valves can be implanted within a docking device implanted within or at the native mitral valve, such as disclosed in PCT Publication No. W02020/247907, which is incorporated herein by reference. In some example, the disclosed prosthetic valves can be implanted within a docking device implanted within the superior or inferior vena cava for replacing the function of a diseased tricuspid valve, such as disclosed in U.S. Publication No. 2019/0000615, which is incorporated herein by reference.

[0102] FIGS. 1A and IB illustrate an example of a prosthetic valve 100 (which also may be referred to herein as “prosthetic heart valve 100”) having a frame 102. FIGS. 1A and IB show the frame 102 with a valvular structure 150 (which can comprise leaflets 158, as described further below) mounted within and to the annular frame 102. FIG. IB additionally shows an optional skirt assembly comprising an outer skirt 103.

[0103] As shown in FIGS. 1A and IB, the valvular structure 150 is coupled to and supported inside the frame 102. The valvular structure 150 is configured to regulate the flow of blood through the prosthetic valve 100, from an inflow end portion 134 to an outflow end portion 136. The valvular structure 150 can include, for example, a leaflet assembly comprising one or more leaflets 158 made of flexible material. The leaflets 158 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). The leaflets 158 can be secured to one another at their adjacent sides to form commissures 152, each of which can be secured to a respective commissure support structure 144 (also referred to herein as “commissure supports”) and/or to other portions of the frame 102, as described in greater detail below.

[0104] In the example depicted in FIGS. 1A and IB, the valvular structure 150 includes three leaflets 158, which can be arranged to collapse in a tricuspid arrangement. Each leaflet 158 can have an inflow edge portion 160 (which can also be referred to as a cusp edge portion) (FIG. 1A). The inflow edge portions 160 of the leaflets 158 can define an undulating edge that generally follows or tracks portions of struts 112 of frame 102 in a circumferential direction. The inflow edge portions 160 of the leaflets 158 can be referred to as a “scallop line.”

[0105] The prosthetic valve 100 may include one or more skirts mounted around the frame 102. For example, as shown in FIG. IB, the prosthetic valve 100 may include an outer skirt 103 mounted around an outer surface of the frame 102. The outer skirt 103 can function as a sealing member for the prosthetic valve 100 by sealing against the tissue of the native valve annulus and helping to reduce paravalvular leakage past the prosthetic valve 100. In some cases, an inner skirt (not shown) may be mounted around an inner surface of the frame 102. The inner skirt can function as a sealing member to prevent or decrease perivalvular leakage, to anchor the leaflets 158 to the frame 102, and/or to protect the leaflets 158 against damage caused by contact with the frame 102 during crimping and during working cycles of the prosthetic valve 100. In some examples, the inflow edge portions 160 of the leaflets 158 can be sutured to the inner skirt generally along the scallop line. The inner skirt can in turn be sutured to adjacent struts 112 of the frame 102. In some examples, as shown in FIG. 1A, the leaflets 158 can be sutured directly to the frame 102 or to a reinforcing member 125 (also referred to as a reinforcing skirt or connecting skirt) in the form of a strip of material (for example, a fabric strip) which is then sutured to the frame 102, along the scallop line via stitches (for example, whip stitches) 133.

[0106] The inner skirt, the outer skirt 103, and the connecting skirt 125 can be formed from any of various suitable biocompatible materials, including any of various synthetic materials, including fabrics (for example, polyethylene terephthalate fabric (PET fabric)), coated fabrics or films (for example, made from polymeric materials such as, for example, PTFE, PET, polypropylene, polyamide, polyetheretherketone (PEEK), etc., layers or films), and/or natural tissue (for example, pericardial tissue). In other words, one or more of the skirts can be wholly or partly formed of any suitable biological material, synthetic material (for example, any of various polymers), or combinations thereof. In some examples, one or more of the skirts can comprise a fabric having interlaced yarns or fibers, such as in the form of a woven, braided, or knitted fabric. In some examples, the fabric can have a plush nap or pile. Exemplary fabrics having a plus nap or pile include velour, velvet, velveteen, corduroy, terrycloth, fleece, etc. In some examples, one or more of the skirts can comprise a fabric without interlaced yarns or fibers, such as felt or an electrospun fabric. Exemplary materials that can be used for forming such fabrics (with or without interlaced yams or fibers) include, without limitation, polyethylene (PET), ultra-high molecular weight polyethylene (UHMWPE), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyamide etc. In some examples, one or more of the skirt can comprise a non-textile or nonfabric material, such as a film made from any of a variety of polymeric materials, such as PTFE, PET, polypropylene, polyamide, polyetherefherketone (PEEK), polyurethane (such as thermoplastic polyurethane (TPU)), etc. In some examples, one or more of the skirts can comprise a sponge material or foam, such as polyurethane foam. Further details regarding the use of skirts or sealing members in prosthetic valve can be found, for example, in U.S. Patent Publication No. 2020/0352711, which is incorporated herein by reference.

[0107] Further details regarding the assembly of the leaflet assembly and the assembly of the leaflets and the skirts to the frame can be found, for example, in U.S. Provisional Application Nos. 63/209,904, filed June 11, 2021, and 63/224,534, filed July 22, 2021, which are incorporated herein by reference.

[0108] The frame 102 comprises and inflow end 109, an outflow end 108, and a plurality of axially extending posts 104. The axial direction of the frame 102 is indicated by a longitudinal axis 105, which extends from the inflow end 109 to the outflow end 108. Some of the posts 104 can be arranged in pairs of axially aligned first and second struts or posts 122, 124. One or more of posts 104 can be configured as support posts 107.

[0109] The posts 104 can be coupled together by a plurality of circumferentially extending link members or struts 112. Each strut 112 extends circumferentially between adjacent posts 104 to connect all of the axially extending posts 104. As one example, the prosthetic valve 100 can include equal numbers of support posts 107 and pairs of posts 122, 124 and the pairs of posts 122, 124 and the support posts 107 can be arranged in an alternating order such that each strut 112 is positioned between one of the pairs of posts 122, 124 and one of the support posts 107 (that is, each strut 112 can be coupled on one end to one of the posts 122, 124 and can be coupled on the other end to one of the support posts 107). However, the prosthetic valve 100 can include different numbers of support posts 107 and pairs of posts 122, 124 and/or the pairs of posts 122, 124 and the support posts 107 can be arranged in a nonalternating order, in some examples. [0110] As illustrated in FIG. 1A, the struts 112 can include a first row of struts 113 at or near the inflow end 109 of the prosthetic valve 100, a second row of struts 114 at or near the outflow end 108 of the prosthetic valve 100, and third and fourth rows of struts 115, 116, respectively, positioned axially between the first and second rows of struts 113, 114. The struts 112 can form and/or define a plurality of cells (that is, openings) in the frame 102. For example, the struts 113, 114, 115, and 116 can at least partially form and/or define a plurality of first cells 117 and a plurality of second cells 118 that extend circumferentially around the frame 102. Specifically, each first cell 117 can be formed by two struts of the first row of struts 113, two struts of the second row of struts 114, and two of the support posts 107. Each second cell 118 can be formed by two struts of the third row of struts 115 and two struts of the fourth row of struts 116. As illustrated in FIG. 1A, each second cell 118 can be disposed within one of the first cells 117.

[0111] Also illustrated in FIG. 1A, the struts 112 of frame 102 can comprise a curved shape. Each first cell 117 can have an axially-extending hexagonal shape including first and second apices 119 (for example, an inflow apex 119a and an outflow apex 119b). In examples where the delivery apparatus is releasably connected to the outflow apices 119b (as described below), each inflow apex 119a can be referred to as a “distal apex” and each outflow apex 119b can be referred to as a “proximal apex”. Each second cell 118 can have a diamond shape including first and second apices 120 (for example, distal apex 120a and proximal apex 120b). In some examples, the frame 102 comprises six first cells 117 extending circumferentially in a row, six second cells 118 extending circumferentially in a row within the six first cells 117, and twelve posts 104. However, in some examples, the frame 102 can comprise a greater or fewer number of first cells 117 and a correspondingly greater or fewer number of second cells 118 and posts 104.

[0112] As noted above, some of the posts 104 can be arranged in pairs of first and second posts 122, 124. The posts 122, 124 are aligned with each other along the length of the frame 102 and are axially separated from one another by a gap (an open space of the second cells 118). Each first post 122 (that is, the lower post shown in FIG. 1A) can extend axially from the inflow end 109 of the prosthetic valve 100 toward the second post 124, and the second post 124 can extend axially from the outflow end 108 of the prosthetic valve 100 toward the first post 122. For example, each first post 122 can be connected to and extend from an inflow apex 119a and each second post 124 can be connected to and extend from an outflow apex 119b. In examples where the delivery apparatus can be releasably connected to the outflow end 108 of the frame 102, the first posts 122 can be referred to as distal posts or distal axial struts and the second posts 124 can be referred to as proximal posts or proximal axial struts.

[0113] As introduced above, some of the posts 104 can be configured as support posts 107. The support posts 107 can extend axially between the inflow and outflow ends 109, 108 of the frame 102 and each can have an inflow end portion 138 and an outflow end portion 139. The outflow end portion 139 of one or more support posts 107 can include a commissure support structure or member 144. The commissure support structure 144 can comprise strut portions defining a commissure opening or slot therein (not shown).

[0114] The commissure opening (which can also be referred to herein as a “commissure window”) can extend radially through a thickness of the support post 107 and can be configured to accept a portion of a valvular structure 150 (for example, a commissure 152) to couple the valvular structure 150 to the frame 102. For example, each commissure 152 can be mounted to a respective commissure support structure 144, such as by inserting a pair of commissure tabs of adjacent leaflets 158 through the commissure opening and suturing the commissure tabs to each other and/or the commissure support structure 144. In some examples, the commissure opening can be fully enclosed by the support post 107 such that a portion of the valvular structure 150 can be slid radially through the commissure opening, from an interior to an exterior of the frame 102, during assembly. In one example, the commissure opening has a substantially rectangular shape that is shaped and sized to receive commissure tabs of two adjacent leaflets therethrough. However, in some examples, the commissure opening can have any of various shapes (for example, square, oval, square-oval, triangular, L-shaped, T-shaped, C-shaped, etc.).

[0115] The commissure openings are spaced apart about the circumference of frame 102 (or angularly spaced apart about frame 102). The spacing may or may not be even. In one example, the commissure openings are axially offset from the outflow end 108 of the frame 102 by an offset distance d (indicated in FIG. IB). As an example, the offset distance da may be in a range from 2 mm to 6 mm. In general, the offset distance da should be selected such that when the leaflets are attached to the frame 102 via the commissure openings, the free edge portions (for example, outflow edge portions) of the leaflets 158 will not protrude from or past the outflow end 108 of the frame 102.

[0116] The frame 102 can comprise any number of support posts 107, any number of which can be configured as commissure support structures 144. For example, the frame 102 can comprise six support posts 107, three of which are configured as commissure support structures 144. However, in some examples, the frame 102 can comprise more or less than six support posts 107 and/or more or less than three commissure support structures 144.

[0117] The inflow end portion 138 of each support post 107 can comprise an extension 154 that extends toward the inflow end 109 of the frame 102. In some examples, each extension 154 can comprise an aperture extending radially through a thickness of the extension 154. In some examples, the extension 154 can extend such that an inflow edge of the extension 154 aligns with or substantially aligns with the inflow end 109 of the frame 102. In use, the extension 154 can prevent or mitigate portions of an outer skirt from extending radially inwardly and thereby prevent or mitigate any obstruction of flow through the frame 102 caused by the outer skirt. The extensions 154 can further serve as supports to which portions of the inner and/or outer skirts and/or the leaflets and/or the connecting skirt 125 can be coupled. For example, sutures used to connect the inner and/or outer skirts and/or the leaflets and/or the connecting skirt 125 can be wrapped around the extensions 154 and/or can extend through the apertures therein.

[0118] As an example, each extension 154 can have an aperture or other features to receive a suture or other attachment material for connecting an adjacent inflow edge portion 160 of a leaflet 158 (FIG. 1A), the outer skirt 103 (in FIG. IB), the connecting skirt 125, and/or an inner skirt. In some examples, the inflow edge portion 160 of each leaflet 158 can be connected to a corresponding extension via a suture 135 (FIG. 1A).

[0119] In some examples, the outer skirt 103 can be mounted around the outer surface of the frame 102 as shown in FIG. IB and the inflow edge of the outer skirt 103 (lower edge in FIG. IB) can be attached to the connecting skirt 125 and/or the inflow edge portions 160 of the leaflets 158 that have already been secured to frame 102 as well as to the extensions 154 of the frame by sutures 129. The outflow edge of the outer skirt 103 (the upper edge in FIG. IB) can be attached to selected struts with stitches 137. In implementations where the prosthetic valve includes an inner skirt, the inflow edge of the inner skirt can be secured to the inflow edge portions 160 before securing the cusp edge portions to the frame so that the inner skirt will be between the leaflets and the inner surface of the frame. After the inner skirt and leaflets are secured in place, then the outer skirt can be mounted around the frame as described above.

[0120] The frame 102 can be a unitary and/or fastener- free frame that can be constructed from a single piece of shape-memory material, such as in the form of a tube. The plurality of cells can be formed by removing portions (for example, via laser cutting) of the single piece of material. Alternatively, the frame 102 can be formed from multiple pieces, sections, or strips that are connected together, such as via welding.

[0121] The frame 102 can be a self-expandable frame comprised of a shape-memory material, such as Nitinol, that biases the frame 102 toward an expanded configuration, but can be radially compressed when a force is applied thereto. In examples where a frame is formed from a shape-memory material, the prosthetic valve including the expandable frame can be placed in a radially compressed state along the distal end portion of a delivery apparatus for insertion into a patient’s body. The frame can be configured such that, when at the desired implantation site, it can self-expand to cause the prosthetic valve to transition from the radially compressed state to a radially expanded state. In some examples, the prosthetic valve can be fully self-expandable. In alternate examples, the prosthetic valve can be at least partially self-expanded in a first stage of deployment and can be fully expanded and/or locked into the radially expanded state by an actuator mechanism of the delivery apparatus in a second stage of deployment.

[0122] In some examples, during delivery to the implantation site, the prosthetic valve 100 can be placed inside of a delivery capsule (sheath) to protect against the prosthetic valve contacting the patient’s vasculature, such as when the prosthetic valve is advanced through a femoral artery. The capsule can also maintain the prosthetic valve 100 in the radially compressed state while it is being delivered to the implantation site. When at the desired implantation site, the prosthetic valve 100 can be deployed or released from the capsule by retracting the sheath in a distal to proximal direction relative to the prosthetic valve, or advancing the prosthetic valve 100 in a distal to proximal direction relative to the sheath. In some examples, the prosthetic valve 100 can be attached or tethered to one or more actuators member and/or one or more deployment shafts to control deployment of the prosthetic valve from the capsule.

[0123] In some examples, deployment of the prosthetic valve 100 from the capsule can enable or cause radial expansion of successive sections of the prosthetic valve as the valve is progressively freed from or deployed from the capsule. In other words, first the inflow end portion 134 can be freed from the capsule and at least partially radially expanded. Next, a central portion (between the inflow end 134 and the outflow end 136) of the valve can be freed from the capsule and at least partially radially expanded, while the inflow end portion 134 transitions to a fully expanded state. Lastly, the outflow end 136 can be freed from the capsule and radially expanded along with the central portion of the prosthetic valve.

[0124] In some examples, the frame 102 can be formed from a plastically-expandable material. Suitable plastically-expandable materials that can be used to form the frame 12 include, without limitation, stainless steel, a nickel-based alloy (for example, a cobaltchromium or a nickel-cobalt-chromium alloy), polymers, or combinations thereof. In particular examples, the frame 12 is made of a nickel-cobalt-chromium-molybdenum alloy, such as MP35N™ (tradename of SPS Technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N™/UNS R3OO35 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight. When the frame 102 is formed from a plastically-expandable material, the prosthetic valve can be radially compressed to a radially compressed on or adjacent a balloon of a delivery apparatus and radially expanded to a radially expanded state by inflation of the balloon, such as disclosed in U.S. Publication No. 2013/0030519, which is incorporated herein by reference. In some examples, the prosthetic valve having a plastically-expandable frame can include one or more mechanical actuators releasably coupled to respective actuation assemblies of a delivery apparatus, such as disclosed in PCT Application No. PCT/US2021/052745, filed September 30, 2021, which is incorporated herein by reference. The actuation assemblies are configured to actuate the actuators of the prosthetic valve to produce radial expansion of the prosthetic valve from the radially compressed state to the radially expanded state.

[0125] FIG. 2 shows an exemplary delivery assembly that can be used to deliver a prosthetic heart valve (such as the prosthetic valve 100 and/or other prosthetic valves disclosed herein) to a native heart valve. Specifically, FIG. 2 illustrates a delivery apparatus 201, according to one example, adapted to advance a prosthetic heart valve 200 (or other prosthetic heart valve), through a patient’s vasculature and/or to deliver the prosthetic heart valve 200 to an implantation site (for example, native heart valve) within a patient’s body. The prosthetic heart valve 200 can be mounted on, retained within, and/or releasably coupled to a distal end portion of the delivery apparatus 201.

[0126] The prosthetic heart valve 200 can have a similar structure to the prosthetic heart valve 100 (described in detail above) and can include a frame 202 having an outer skirt 203 mounted on an outer surface thereof. Further, the prosthetic heart valve 200 can include a distal end 204 (which can be the inflow end of the prosthetic valve 200, such as when the prosthetic heart valve 200 is configured to replace a defective aortic valve when delivered transfemorally) and a proximal end 205 (which can be the outflow end of the prosthetic valve 200, such as when the prosthetic heart valve 200 is configured to replace a defective aortic valve when delivered transfemorally), wherein the proximal end 205 is positioned closer to a handle 206 of the delivery apparatus 201 than the distal end 204, and wherein the distal end 204 is positioned farther from the handle 206 than the proximal end 205. It should be understood that the delivery apparatus 201 and other delivery apparatuses disclosed herein can be used to implant prosthetic devices other than prosthetic valves, such as stents or grafts.

[0127] The delivery apparatus 201 in the illustrated example generally includes the handle 206, a first elongated shaft 207 (which comprises an outer shaft in the illustrated example) extending distally from the handle 206, one or more actuator members 208 extending distally through the shaft 207, and one or more support members 209 that can extend distally through the shaft 207 and can abut the proximal end 205 of the prosthetic valve 200. The delivery apparatus 201 can further include an inner shaft 220 extending from the handle 206 through the outer shaft 207 and a nose cone 222 connected to the distal end portion of the inner shaft 220.

[0128] As discussed above, the prosthetic valve 200 can be partially self-expanding or fully self-expanding. That is, the prosthetic valve 200 can be configured to self-expand from a radially compressed, delivery state to at least a partially radially expanded state. When configured to be self-expanding, the frame of the prosthetic valve 200 can be constructed from a shape-memory material (for example, Nitinol) that biases the prosthetic valve 200 towards a radially expanded state. In such examples, the struts can be configured and connected to each other such that the frame has some inherent resiliency that causes the frame to self-expand to at least a partially radially expanded state when released from a constraining member (for example, a delivery sheath or capsule). Further, the prosthetic valve 200 can be shape set in the partially radially expanded state or the fully radially expanded state so that the prosthetic valve 200 returns to the shape set radially expanded state when released from a restraining mechanism (for example, lasso, sheath, capsule, and/or outer skirt, etc.).

[0129] For example, the prosthetic valve 200 can be configured to self-expand to a partially radially expanded state, and the actuator members 208 can be actuated to further radially expand the prosthetic valve to the fully radially expanded state. Thus, in such examples, the prosthetic valve 200 can be both self-expanding and mechanically expandable.

[0130] In such examples, each actuator member 208 can have a distal end connected to the distal end of the prosthetic valve 200. Each of the actuator members 208 can extend through a respective support member 209 and together can define a respective actuator assembly that can extend through the shaft to the handle 206. In alternate examples, the actuator members 208 and the support members 209 need not be co-axial with respect to each and instead can extend side-by-side through the shaft.

[0131] After the prosthetic valve 200 is partially self-expanded, the actuator members 208 and/or the support members 209 can be configured to radially expand the prosthetic heart valve 200 by bringing the ends 204, 205 of the prosthetic valve 200 closer together (that is, squeezing the prosthetic valve 200 axially) thereby axially foreshortening and radially expanding the prosthetic valve 202. As one example, the actuator members 208 can be configured to be actuated to provide a proximally directed (for example, pulling) force to the distal end 204 of the prosthetic valve 200 while the one or more support members 209 can be configured to provide a countervailing distally directed (for example, pushing) force to the proximal end 205 of the prosthetic valve 200. As one such example, a physician can pull the actuator members 208 to provide the proximally directed force to the distal end 204 of the prosthetic valve 200, while simultaneously gripping, holding, and/or pushing the handle 206 to provide the countervailing distally directed force to the proximal end 205 of the prosthetic valve 200. [0132] The actuator members 208 can comprise a suture, string, cord, wire, cable, or other similar device that can transmit a pulling force from the handle 206 to the prosthetic valve when actuated by a physician. The support members 209 can comprise a relatively more rigid component, such a tube that can abut the proximal end 205 of the prosthetic valve 200 and resist proximal movement of the prosthetic valve relative to the shaft 207 when a proximal pulling force is applied to the actuator members 208.

[0133] Although two actuator members 208 and two support members 209 are shown in FIG. 2, it should be understood that the delivery apparatus 201 can include more or less than two actuator members 208 and/or two support members 209, in some examples. As just one example, the delivery apparatus 201 can include six actuator members 208 and/or six support members 209. In some examples, a greater or fewer number of actuator members 208 and/or support members 209 can be present, such as three, four, five, seven, and/or eight actuator members 208 and/or three, four, five, seven, and/or eight support members 209. In some examples, the delivery apparatus 201 can include equal numbers of actuator members 208 and support members 209. However, in some examples, the delivery apparatus 201 can include a different number of actuator members 208 than support members 209.

[0134] In some examples, the prosthetic valve 200 can be configured to self-expand to the fully radially expanded state and the actuator members 208 can be actuated to, for example, lock the prosthetic valve 200 in the fully radially expanded state or the actuator members 208 can be excluded from the delivery apparatus 201.

[0135] In some examples, the shaft 207 can have a distal end portion 224 sized to house the prosthetic valve in its radially compressed, delivery state during delivery of the prosthetic valve through the patient’ s vasculature. In this manner, the distal end portion 224 functions as a delivery sheath or capsule for the prosthetic valve during delivery, and as such may be referred to herein as a capsule 224.

[0136] Similar to prosthetic valve 100, in some examples, deployment of the prosthetic valve 200 from the capsule 224 can enable or cause radial expansion of successive sections of the prosthetic valve as the valve 200 is progressively freed from or deployed from the capsule 224. Alternatively, the prosthetic valve 200 can include an outer skirt configured to control radial expansion thereof (for example, the outer skirt 303 shown in FIGS. 3-5E and described in detail below), such that when the valve 200 is freed from the capsule 224, the prosthetic valve is maintained in the radially compressed state and expansion is controlled via outer skirt and an associated delivery apparatus.

[0137] The handle 206 of the delivery apparatus 201 can include one or more control mechanisms (for example, knobs or other actuating mechanisms) for controlling different components of the delivery apparatus 201 in order to implant the prosthetic heart valve 200. For example, in the illustrated example the handle 206 can comprise one or more of first, second, and third knobs 210, 212, and 214.

[0138] When included, the first knob 210 can be configured to produce axial movement of the shaft 207 relative to the prosthetic heart valve 200 in the distal and/or proximal directions in order to deploy the prosthetic valve 200 from the capsule 224 once the prosthetic valve 200 has been advanced to a location at or adjacent the desired implantation location within the patient’s body. For example, actuating the first knob 210 in a first direction (for example, clockwise) can retract the shaft 207 proximally relative to the prosthetic heart valve 200 and actuation of the first knob 210 in a second direction (for example, counter-clockwise) can advance the shaft 207 distally. The first knob 210 can be actuated by rotating the knob as indicated above, or by sliding or moving the knob axially, such as by pulling and/or pushing the knob.

[0139] When included, the second knob 212 can be configured to actuate the actuator members 208 to radially expand and/or lock the prosthetic heart valve 200. For example, actuating the second knob 212 can pull the actuator members 208 proximally relative to the support members 209, thereby radially expanding the prosthetic heart valve 200 and locking the prosthetic heart valve 200 in its current state/position. The second knob 212 can be actuated by rotating the knob, or by sliding or moving the knob axially, such as by pulling and/or pushing the knob.

[0140] In some examples, the second knob 212 may not be included, and a physician can expand and/or lock the prosthetic heart valve 200 by directly actuating (for example, pulling) the actuator members 208. In such examples, the actuator members 208 can extend through and/or out of the handle 206 so that they are directly accessible to the physician and/or can be easily pulled by the physician. After radially expanding and locking the heart valve 200, the physician can cut the actuator members 208, such as at and/or near a locking element (for example, locking element 240 described below) of the heart valve 200. The delivery apparatus 201 can include one or more cutting elements that can be actuated by the user to cut the actuator members 208 near the prosthetic valve, such as disclosed in U.S. Publication No. 2018/0153689, which is incorporated by reference herein.

[0141] When included, the third knob 214 can be configured to be actuated to retain the prosthetic heart valve 200 in its expanded configuration. For example, the third knob 214 can be operatively connected to a locking tool and can be actuated (for example, rotated) to move the locking tool from a disengaged to an engaged state (to lock the prosthetic valve 200) and/or from the engaged state to the disengaged state (to unlock the prosthetic valve 200).

For example, a physician can lock the prosthetic valve 200 to prevent the prosthetic valve 200 from collapsing and/or can unlock the prosthetic valve 200 to partially compress and/or reposition the prosthetic valve 200 relative to the native tissue. The third knob 214 can be actuated by rotating the knob, or by sliding or moving the third knob axially, such as by pulling and/or pushing the knob.

[0142] However, in some examples, the third knob 214 may not be included. In some such examples, the prosthetic valve 200 can be self-locking and may not require any action from the physician to lock at a particular valve diameter. That is, the locking mechanism can automatically and/or continuously lock the prosthetic valve 200 at a range of valve diameters, without needing to be engaged/activated by the physician.

[0143] Further, the handle 206 can include additional knobs or actuators to carry out other functions or the first, second, and/or third knobs can have functions other than those described above. For example, one of the first, second, or third knobs or other knobs or actuators of the handle can each be configured to control or retract one or more expansion control members (such as for example, one or more of a plurality of expansion control members 311, 313 shown in FIGS. 3, 5A-5E, 7 and 9 and discussed in detail below) to control gradual radial expansion of the prosthetic valve.

[0144] Additional features of the delivery apparatus 201 that can be utilized with the prosthetic valves disclosed herein are described in U.S. Provisional Patent Application No. 63/179,766 filed on April 26, 2021, which is incorporated by reference herein. It will be appreciated that the delivery apparatus disclosed herein can include other features and/or the prosthetic valves disclosed herein can be utilized with other types of delivery apparatus, such as those described in U.S. Patent No. 9,867,700, which is incorporated by reference herein.

[0145] In some examples, the prosthetic valves 100, 200 can include an outer skirt that receives expansion control members for controlling the radial expansion of the prosthetic valve, such that when the prosthetic valve is freed from the capsule or delivery sheath or other delivery shaft, the prosthetic valve is maintained in the radially compressed state and/or radial expansion of the prosthetic valve is limited, and the prosthetic valve can be radial expanded in a step-wise manner. For example, the prosthetic valves 100, 200 can include (rather than the outer skirt 103) an outer skirt 303 configured to receive expansion control members to control the radial expansion of the prosthetic valve, as shown in FIGS. 3- 5E and described in detail below.

[0146] Turning now to FIGS. 3-4B, a prosthetic valve 300 including the outer skirt 303 configured to receive expansion control members or release members is shown and described. For illustrative purposes, a frame 302 of the prosthetic valve 300 is shown with the outer skirt 303 disposed on an outer surface thereof, and other portions of the prosthetic valve are removed. It will be appreciated that the prosthetic valve 300 can include one or more of the valve components described above with respect to the prosthetic valves 100, 200. For example, the prosthetic valve 300 can include a valvular structure, an inner skirt, a connecting skirt, and other prosthetic valve elements described above. In some examples, the prosthetic valve can include additional components, fewer components, or components having a different configuration relative to those described above with reference to the prosthetic valves 100, 200.

[0147] In the present example, the structure of the frame 302 substantially corresponds to the structure of the frame 102 and the description thereof can be applied to the frame 302. In some examples, the prosthetic valve 300 can include a self-expandable frame having a different configuration, such as one of the self-expandable frames disclosed in U.S. Patent No. 9,867,700 or in U.S. Provisional Patent Application No. 63/179,766, each previously incorporated herein. [0148] The frame 302 can be a self-expandable frame comprised of a shape-memory material (for example, Nitinol) that biases the frame 302 toward an expanded configuration, but can be radially compressed when a force is applied thereto. FIG. 3 illustrates the frame 302 in the radially expanded configuration, and the frame 302 can be moved into a radially compressed configuration by applying a force to the frame 302 that causes the frame to axially elongate and decrease a distance between adjacent struts of the frame.

[0149] In examples where the frame is formed from a shape- memory material, the prosthetic valve 300 can be placed in a radially compressed state along the distal end portion of a delivery apparatus for insertion into a patient’s body. When at the desired implantation site, the frame 302 can be configured to self-expand or partially self-expand to cause the prosthetic valve to transition from the radially compressed state to a radially expanded state.

[0150] In some examples, during delivery to the implantation site, the prosthetic valve 300 can be placed inside of a delivery capsule (sheath) to protect against the prosthetic valve contacting the patient’s vasculature, such as when the prosthetic valve is advanced through a femoral artery. The capsule can maintain the prosthetic valve in the radially compressed state while it is being delivered to the implantation site. When at the desired implantation site, the prosthetic valve can be released from the capsule by retracting the sheath in a distal to proximal direction relative to the prosthetic valve, or advancing the prosthetic valve in a distal to proximal direction relative to the sheath. In some examples, the outer skirt 303 and expansion control members 311 are configured to maintain the prosthetic valve in the radially compressed state after release from the capsule.

[0151] In some examples, the prosthetic valve 300 including the outer skirt 303 can be delivered without a delivery capsule, and the valve can be maintained in a radially compressed state via the outer skirt and expansion control members 311 during transcatheter delivery of the prosthetic valve to the implantation site. In other words, the prosthetic valve 300 can be maintained in the radially compressed state without use of a delivery capsule (using only the outer skirt 303 and expansion control members 311).

[0152] In both of the foregoing examples, after positioning of the valve at the target site, the outer skirt 303 and expansion control members 311 enable step- wise or controlled gradual transition of the prosthetic valve 300 from the radially compressed state to a radially expanded state.

[0153] As illustrated in FIG. 3, the outer skirt 303 can be mounted around an outer surface of the frame 302. For example, the outer skirt can be sutured to selected struts of the frame 302, such as shown in FIG. 1B. When the prosthetic valve 300 is implanted, the outer skirt 303 can function as a sealing member for the prosthetic valve 300 by sealing against the tissue of the native valve annulus and helping to reduce paravalvular leakage past the prosthetic valve 300.

[0154] The outer skirt 303 can be formed from any of the various suitable biocompatible materials discussed above, including any of various synthetic materials, including fabrics (for example, polyethylene terephthalate fabric), coated fabrics or films (for example, films made of polymeric materials such as PTFE, PET, polypropylene, polyamide, polyetheretherketone (PEEK), etc.), or natural tissue (for example, pericardial tissue). In other words, the outer skirt 303 can be wholly or partly formed of any suitable biological material, synthetic material (for example, any of various polymers), or combinations thereof. In some examples, the outer skirt 303 can comprise a fabric having interlaced yams or fibers, such as in the form of a woven, braided, or knitted fabric. In some examples, the fabric can have a plush nap or pile. Exemplary fabrics having a plus nap or pile include velour, velvet, velveteen, corduroy, terrycloth. fleece, etc. In some examples, the outer skirt 303 can comprise a fabric without interlaced yams or fibers, such as felt or an electrospun fabric. Exemplary materials that can be used for forming such fabrics (with or without interlaced yams or fibers) include, without limitation, polyethylene (PET), ultra-high molecular weight polyethylene (UHMWPE), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyamide etc. In some examples, the outer skirt 303 can comprise a non-textile or non-fabric material, such as a film made from any of a variety of polymeric materials, such as PTFE, PET, polypropylene, polyamide, polyetheretherketone (PEEK), polyurethane (such as thermoplastic polyurethane (TP1..0), etc. In some examples, the outer skirt 303 can comprise a sponge material or foam, such as polyurethane foam.

[0155] As can be seen in FIG. 3, the outer skirt 303 includes a plurality of axially extending sleeves 360 formed on or disposed on an outer surface of the outer skirt 303. Specifically, in the present example, the outer skirt 303 includes four axial sleeves 360a, 360b, 360c, 360d that each extend from an inflow (for example, distal) edge 362 of the outer skirt 303 to an outflow (for example, proximal) edge 364 of the outer skirt 303. The inflow edge 362 can be proximate to or aligned with an inflow end portion 334 of the prosthetic valve 300 and the outflow edge 364 can be proximate to or aligned with an outflow end portion 336 of the prosthetic valve 300. In some examples, the outer skirt 303 need not extend the entire height of the frame and the inflow and outflow edges can be at locations spaced from the inflow and outflow ends of the frame. In some examples, the outer skirt can include more or fewer axial sleeves (discussed further below) and/or the axial sleeve can be formed on or disposed on an interior surface of the outer skirt.

[0156] In some examples, the axial sleeves 360 can each be formed from a portion of the outer skirt material by folding over a section of the outer skirt and forming an attachment line (via for example, machine stitching, hand stitching, application of an adhesive, heat pressing, or another attachment or bonding method) extending from the inflow edge 362 to the outflow edge 364 of the outer skirt 303. In alternate examples, the axial sleeves 360 can be preformed tubes having a length corresponding to a height of the outer skirt and can be attached to the outer skirt 303 via suturing, application of an adhesive, heat pressing, or another attachment method. In some examples, the axial sleeves 360 (whether preformed or formed from folding sections of the skirt) have a length that is less than the height of the skirt 303.

[0157] In some examples, the axial sleeves can have a different configuration, such as being discontinuous tubes or sleeves. In such examples, the axial sleeves can each comprise two or more smaller axially aligned sleeve sections or rings, which may include, for example, a first sleeve section or ring disposed proximate to the inflow edge of the outer skirt and a second sleeve or ring disposed proximate to the outflow edge of the outer skirt, and may further include one or more additional sleeve sections or rings axially aligned with and disposed therebetween. A gap or space may be disposed between each of the axial sleeve sections or rings. Each of the axial sleeve sections or rings can be attached to or formed in the outer skirt via one or more the methods discussed above.

[0158] In the example of FIG. 3, each of the axial sleeves 360 is configured to receive or have one of a plurality of expansion control members 311 inserted therethrough. In some examples, the expansion control members 311 are components of a delivery apparatus 301 (shown in FIGS. 5A-5E), which may have a similar configuration to the delivery apparatus 201 described above with reference to FIG. 2. In the present example, expansion control members 311a, 311b, 311c, 31 Id are respectively received within the axial sleeves 360a, 360b, 360c, 360d. In alternate examples, each of the axial sleeves 360 can have more than one expansion control member received therein.

[0159] It will be appreciated that, for illustrative purposes, the frame 302 is shown in FIG. 3 in a radially expanded configuration while the expansion control members 311 are received within the axial sleeves. However, as discussed in detail below, during implantation of the prosthetic valve 300, the valve is transitioned into the radially expanded state via withdrawal of the expansion control members 311 from the axial sleeves 360.

[0160] Turning to FIGS. 4A and 4B, schematic illustrations of the outer skirt 303 show that the four axial sleeves 360a, 360b, 360c, 360d each have a section of the outer skirt disposed therebetween (that is, skirt sections 303a, 303b, 303c, 303d). Further, each of the axial sleeves 360 is oriented and formed within the skirt to be substantially parallel to a longitudinal axis of the frame 302. FIG. 4A shows the outer skirt 303 apart from the frame 302 in an unrolled and flattened configuration. FIG. 4B shows the outer skirt 303 mounted around the frame 302.

[0161] In the present example, the axial sleeves 360 have an uneven spacing or distribution on the outer skirt 303 in the circumferential direction. In other words, each of the skirt sections 303a, 303b, 303c, 303d has a different width a, b, c, d, which make up a total circumference e of the outer skirt 303. Further, a height/of the outer skirt 303 corresponds to a length of each of the axial sleeves 360, and each axial sleeve has a diameter g.

[0162] As can be seen in FIGS. 4 A and 4B, the circumference e of the outer skirt 303 corresponds to a circumference of the frame 302. In one specific example, the circumference e of the outer skirt is 91 mm, which is equal to a circumference of the frame 302. As noted above, in the radially expanded state (shown in FIG. 4B), the axial sleeves 360a, 360b, 360c, 360d have an uneven distribution along the circumferences of the outer skirt 303 and the frame 302. In alternate examples, the axial sleeves can be evenly distributed along the circumferences of the outer skirt 303 and the frame 302. The specified distribution of the sleeves may allow for selected lengths of the outer skirt 303 to be released during each step of the step-wise transitioning the prosthetic valve 300 from the radially compressed state to the radially expanded state.

[0163] Step-wise transitioning of the prosthetic valve 300 from a radially compressed state to a radially expanded state is illustrated in FIGS. 5A-5E. As discussed above, the delivery apparatus 301 can be adapted to advance the prosthetic heart valve 300 (in a radially compressed state), through a patient’s vasculature to deliver the prosthetic heart valve 300 to an implantation site (for example, native heart valve) within a patient’s body. The prosthetic heart valve 300 can be retained within a delivery capsule 324 of the delivery apparatus 301. After delivery of the prosthetic heart valve 300 to the implantation site, the prosthetic valve may be deployed from the delivery capsule 324. The delivery capsule 324 in the illustrated example is the distal end portion of an outer shaft 307 of the delivery apparatus 301.

Different from conventional self-expandable prosthetic valve delivery, after deployment from the delivery capsule 324, the prosthetic heart valve 300 is maintained in the radially compressed state via the expansion control members 311 and the outer skirt 303. In some examples, the prosthetic valve need not be retained within the capsule 324 during delivery. Instead, the prosthetic valve can be retained in the radially compressed state by the expansion control members 311 at a location distal to the shaft (the distal end portion of which need not be configured as a capsule for receiving the prosthetic valve) during delivery through a patient’s vasculature.

[0164] As can be seen in FIG. 5A, a distal end of each of the expansion control members can be releasably attached to or retained by a retaining member 321 of the delivery apparatus 301. In some examples, a nose cone 222 can be coupled or attached to a distal end of an inner shaft 320 of the delivery apparatus 301. Further, the retaining member 321 can be coupled or attached to a distal portion of the inner shaft 320 of the delivery apparatus 301 at a position that is proximal relative to the nose cone 322, such that the retaining member 321 is disposed between the nose cone 322 and the prosthetic valve 300. In some examples, the inner shaft 320 extends through and is attached within a central opening of the retaining member 321.

[0165] An end view of the retaining member 321 is shown in FIG. 6. As can be seen (and also in FIGS. 7 and 8), the retaining member 321 can be a generally disc-shaped body including a plurality of apertures 323 therein. In the present example, the retaining member 321 includes four apertures 323a, 323b, 323c, 323d and each aperture is configured to respectively receive and releasably retain a distal portion of one of the expansion control members 311a, 311b, 311c, 31 Id. In alternate examples including additional expansion control members, the retaining member 321 can include additional apertures 323. For example, FIGS. 7 and 8 illustrate exemplary delivery apparatus each including five expansion control members 311 and the retaining member 321 includes a corresponding number of apertures 323. In other alternate examples including additional expansion control members, the apertures 323 can be configured to receive more than one distal portion of an expansion control member.

[0166] In alternate examples, the retaining member 321 can be excluded from the delivery apparatus 301, and the nose cone 322 can include apertures configured to receive and/or releasably retain distal portions of the expansion control members 311, and thereby can have a function similar to the retaining member.

[0167] As shown in FIG. 6, the apertures 323 (unlike the axial sleeves 360) are spaced in a substantially equidistant arrangement on a proximal face of the retaining member 321. For example, the apertures can be equally spaced relative to each other and proximate to a perimeter of the proximal face of the retaining member and/or the apertures can be equally spaced relative to a center point of the proximal face. Thus, in some examples, when the expansion control members 311 are received within the apertures or releasably retained thereby, the expansion control members are spaced substantially equidistant from each other. Such a configuration can create substantially equal force (via the expansion control members) distributed around the circumference of the prosthetic valve 300 while the valve is retained in the radially compressed configuration (as in FIGS. 5A, 7 and 8).

[0168] As best illustrated in FIG. 7, in some examples, the expansion control members can be control wires 319, which are comprised of a relatively thicker and less flexible material relative to other exemplary expansion control members (discussed below). In some examples, the control wires 319 can include a coating, such as a coating configured to increase rigidity, material strength, or biocompatibility of the control wires.

[0169] In examples wherein the delivery apparatus 301 includes control wires 319, a distal tip of each control wire can be configured to be inserted into one of the apertures 323. In some examples, the apertures 323 may include openings on each of a proximal face 325 and a distal face 327 of the retaining member 321. In some examples, the apertures 323 can include an opening on the proximal face 325 and can be closed on the distal face 327 of the retaining member 321. In such examples, the closed distal face 327 can function as a stop for the distal tip of the control wires 319 so that insertion of the wire therethrough is limited.

[0170] A diameter of each of the apertures 323 can be similar to or slightly larger than the diameter of each of the control wires 319, so that lateral movement of the distal tip of the control wire 319 within the retaining member is limited and the distal tip can be securely retained within the aperture 323. In some examples, each of the apertures 323 can include a coating on its interior surface, such as for example, a silicone coating, that can assist in retaining the distal tip of the control wire 319 therein via exerting a slight compressive and/or frictional force on the distal tip.

[0171] It will be appreciated that each of the control wires 319 can extend from the distal tip or end (which is inserted into and retained by the aperture 323) through one of the axial sleeves 360 and into the outer shaft 307 of the delivery apparatus 301. In some examples, a proximal end portion of the control wire 319 can extend through a handle and the delivery apparatus 301 and be exposed so that it can be pulled by a surgeon. In alternate examples, the proximal end portions of the control wire 319 can be operatively coupled to an actuator or knob on a handle of the delivery apparatus (such as one of the actuators 210, 212, 214 of the handle 206 discussed with reference to FIG. 2), which can be configured to retract the control wire in a distal to proximal direction when actuated by the surgeon.

[0172] When a pulling force is applied to the proximal end portion of the control wire 319 in the distal to proximal direction (for example, when the proximal end portion of the control wire is retracted), it can cause the distal tip thereof to be withdrawn from the aperture 323 and pulled through the axial sleeve 360, thereby freeing a corresponding portion of the outer skirt 303 and allowing the prosthetic valve 300 to at least partially radially expand (discussed further below).

[0173] FIG. 8 shows an alternate example where the expansion control members are control tethers 313, which can be comprised of a relatively thinner and more flexible material (as compared to the control wires 319). In some examples, the control tethers 313 can include a coating, such as a coating configured to improve biocompatibility or material strength of the control tethers.

[0174] In examples wherein the delivery apparatus 301 includes control tethers 313, a distal portion of each control tether can be configured to be inserted or looped through one of the apertures 323. In the present example, the apertures 323 include openings on each of a proximal face 325 and a distal face 327 of the retaining member 321. A trailing portion 315 of the distal portion of each control tether 313 can extend from a distal end of an axial sleeve 360 through the aperture 323, and a leading portion 317 can extend from the aperture 323 over an exterior surface or edge of the retaining member 321 and return through the same axial sleeve 360 from which the trailing end portion 315 extends. In some examples, each of the trailing portion 315 and the leading portion 317 can extend or pass through the axial sleeve 360 and into the outer shaft 307 of the delivery apparatus 301.

[0175] Further, in some examples, ends of one or both of the trailing portion 315 or the leading portion 317 can further extend through the handle where the surgeon can pull on one of the exposed ends (a first end). In some examples, one of the ends of the trailing portion 315 or the leading portion 317 (a first end) can be operatively coupled to an actuator or knob on a handle of the delivery apparatus 301 (such as one of the actuators 210, 212, 214 of the handle 206 discussed with reference to FIG. 2), which is configured to cause withdrawal of the corresponding portion of the thread in a distal to proximal direction when actuated by the surgeon. In these examples, an end of the other of the trailing portion 315 or the leading portion 317 (a second end) can be loose within the delivery shaft 207 or can releasably secured (for example, via a clip, an adhesive, a releasable knot, etc.) within the handle such that when the first end is pulled in the proximal to distal direction, the second end is freed from its releasable attachment.

[0176] When the pulling force is applied to the first end of the control tether 313 in the distal to proximal direction (for example, when the first end of the control tether is retracted), it can cause the second end thereof to move in a proximal to distal direction (toward the retaining member) and be pulled through the axial sleeve 360 in a first pass, withdrawn from the aperture 323, and pulled through the axial sleeve 360 in a second pass, thereby freeing a corresponding portion of the outer skirt 303 and allowing the prosthetic valve 300 to at least partially radially expand (discussed further below). [0177] Returning to FIG. 5 A, the prosthetic valve 300 is shown in a radially compressed configuration or state, wherein each of the expansion control members 311 (which are illustrated as control wires, but can be control tethers in alternate examples) extends through the delivery apparatus 301, through one of the axial sleeves 360, and is releasably retained within one of the apertures 323. In the configuration of FIG. 5 A, the expansion control members 311 create equal resistive force distributed around the circumference of the prosthetic valve 300 and the valve is retained in the radially compressed configuration even after deployment or release from the capsule 324 of the delivery apparatus. It will be appreciated that, as the prosthetic valve remains in the radially compressed configuration after release from the delivery capsule, a position of the prosthetic valve 300 can be adjusted by the surgeon after it is free of the delivery capsule (unlike conventional self-expanding valve delivery).

[0178] In examples where the expansion control members 311 are control wires 319, the wires can be configured (for example, a diameter and a material composition) that conveys a sufficient material strength to resist an outward radial force of the self-expandable (or partially self-expandable) frame of the prosthetic valve when the distal end of the wire 319 is inserted into the aperture 323 and proximal portion of the wire extends through the outer shaft 307 of the delivery apparatus 301.

[0179] In alternate examples where the expansion control members 311 are control tethers 313, the threads can have a configuration (for example, a gauge and a material composition) that is sufficient to resist an outward radial force of the self-expandable (or partially selfexpandable) frame of the prosthetic valve when the distal portion of the tether 313 is looped through the aperture 323 and proximal portions of each of the trailing portion 315 and the leading portion 317 of the thread extend through the outer shaft 307 of the delivery apparatus 301 and are attached or coupled within the delivery apparatus to maintain a taut state of the control tether 313.

[0180] Although not specifically shown in the drawings, it will be appreciated that in the radially compressed configuration portions of the skirt sections 303a, 303b, 303c, 303d can include regions of “slack” between the axial sleeves 360. In some examples, the regions of slack can be folded, wrapped, rolled, or otherwise arranged such that they do not extend outwardly from the prosthetic valve 300. In some examples, the slack in the outer skirt 303 can extend outwardly from the prosthetic valve 300.

[0181] As shown in FIG. 5B, when the prosthetic valve 300 is in a desired position, a first expansion control member can be selectively withdrawn to release the compressive force on one section of the prosthetic valve 300 and free a corresponding portion of the outer skirt 303. After withdrawal of the first expansion control member, compressive force on other portions of the prosthetic valve can be maintained by the other (non- withdrawn) control wires.

[0182] In the example of FIG. 5B, the expansion control member 311c is withdrawn from the corresponding aperture 323 and the axial sleeve 360c, while the expansion control members 31 la, 31 1b, 31 I d remain extended through the axial sleeves 360a, 360b, 360d and the distal ends of the expansion control members 311a, 311b, 3 l id are retained within the apertures 323. When the expansion control member 311c is removed, the outer skirt sections 303c and 303d of the outer skirt that were adjacent the expansion control member 311c (on opposing sides thereof) are freed. Further, the resistive force applied to the frame of the prosthetic valve 300 by the expansion control member 311c is removed and the frame can self-expand to a first partially radially expanded state in a first radial expansion step.

[0183] In some examples, a diameter of the valve in the first partially radially expanded state is defined (at least in part) by the released outer skirt sections 303c and 303d. For example, in the radially compressed state the prosthetic valve 300 can have an initial diameter of 7.3 mm. When the expansion control member 311c is withdrawn, slack in the outer skirt sections 303c and 303d is removed as the self-expanding frame pushes the outer skirt 303 radially outward such that the prosthetic valve has, for example, a diameter of 12 mm in the first partially radially expanded state.

[0184] It will be appreciated that, in some examples, both of the inflow end portion 334 and the outflow end portion 336 of the prosthetic valve 300 (as well as central portion disposed therebetween) can be substantially concurrently radially expanded when the expansion control member 311c is withdrawn and the prosthetic valve is expanded into the first partially radially expanded state. Further, in some examples, the prosthetic valve 300 in the first partially expanded state may be of a sufficiently small diameter that a surgeon can adjust a position of the valve at the implantation site. In some examples, a position of the prosthetic valve 300 in the first partially expanded state may not be adjustable.

[0185] As shown in FIG. 5C, after withdrawal of the first expansion control member (and, in some examples, re-positioning of the valve), a second expansion control member can be selectively withdrawn to release the compressive force on another section of the prosthetic valve 300 and free an additional portion of the outer skirt 303. After withdrawal of the second expansion control member, the compressive force on other portions of the prosthetic valve can be maintained by the other (non-withdrawn) expansion control members.

[0186] Specifically, in the example of FIG. 5C, the expansion control member 31 Id is withdrawn from the corresponding aperture 323 and the axial sleeve 360d, while the expansion control members 31 l a, 31 lb remain inserted through the axial sleeves 360a, 360b and the distal ends of the expansion control members 311a, 311b are retained within the apertures 323. When the expansion control member 3 lid is removed, the outer skirt section 303a is freed. Further, the resistive force applied to the frame of the prosthetic valve 300 by the expansion control member 31 Id is removed and the frame can self-expand to a second partially radially expanded state in a second radial expansion step.

[0187] In some examples, a diameter of the valve in the second partially radially expanded state is defined (at least in part) by the released outer skirt section 303a. For example, when the expansion control member 31 lb is withdrawn, slack in the outer skirt section 303a is removed as the self-expanding frame pushes the outer skirt 303 radially outward such that the prosthetic valve has, for example, a diameter of 16 mm in the second partially radially expanded state.

[0188] It will be appreciated that, in some examples, both of the inflow end portion 334 and the outflow end portion 336 of the prosthetic valve 300 (as well as central portion disposed therebetween) can be substantially concurrently radially expanded when the expansion control member 3 lid is withdrawn and the prosthetic valve is expanded into the second partially radially expanded state. Further, in some examples, the prosthetic valve 300 in the second partially expanded state may be of a sufficiently small diameter that a surgeon can adjust a position of the valve at the implantation site. In some examples, a position of the prosthetic valve 300 in the second partially expanded state may not be adjustable. [0189] Turning to FIG. 5D, after withdrawal of the second expansion control member (and, in some examples, re-positioning of the valve), a third expansion control member can be selectively withdrawn to release the compressive force on another section of the prosthetic valve 300 and free an additional portion of the outer skirt 303. In some examples, as only a single expansion control member remains inserted through an axial sleeve of the outer skirt, the remaining expansion control member may still be attached to the prosthetic valve, however, the expansion control member may not apply any resistive force on the prosthetic valve.

[0190] Specifically, in the example of FIG. 5D, the expansion control member 31 la is withdrawn from the corresponding aperture 323 and the axial sleeve 360a, and only the expansion control member 311b remains inserted through the axial sleeves 360b and the distal end of the expansion control member 31 lb is retained within one of the apertures 323. When the expansion control member 311a is removed, the outer skirt section 303b is freed. Further, the resistive force applied to the frame of the prosthetic valve 300 by the expansion control member 311a is removed and the frame can self-expand to a third radially expanded state in a third radial expansion step.

[0191] In some examples where a frame of the prosthetic valve 300 is a fully selfexpandable frame, the third radially expanded state can be a fully radially expanded state of the valve. In some examples where a frame of the prosthetic valve 300 is a partially selfexpandable frame, the third radially expanded state can be a third partially expanded state, and the valve can be transitioned to the fully expanded state via an actuator of the delivery apparatus in a fourth radial expansion step.

[0192] In some examples, a diameter of the valve in the third radially expanded state can be defined (at least in part) by the released outer skirt section 303 a. For example, when the expansion control member 31 lb is withdrawn, slack in the outer skirt section 303a is removed as the self-expanding frame pushes the outer skirt 303 radially outward such that the prosthetic valve has, for example, a diameter of 20 mm in the third radially expanded state.

[0193] It will be appreciated that, in some examples, both of the inflow end portion 334 and the outflow end portion 336 of the prosthetic valve 300 (as well as central portion disposed therebetween) can be substantially concurrently radially expanded when the expansion control member 311a is withdrawn and the prosthetic valve is expanded into the third radially expanded state. As discussed above, in some examples, the third radially expanded state can be a fully expanded state of the prosthetic valve 300, such that the prosthetic valve seated in the patient’s native valve securely engages with the tissue of the native valve and a position of the prosthetic valve is maintained. In some examples, where the third radially expanded state is a third partially expanded state, a position of the prosthetic valve 300 may or may not be adjustable prior to transitioning the valve to the fully expanded state via the actuator.

[0194] Finally, as illustrated in FIG. 5E, the expansion control member 311b can be withdrawn from the axial sleeve 360b so that the prosthetic valve is free of the expansion control members. In examples where the frame is fully self-expandable, the prosthetic valve 300 may be unattached from the delivery apparatus 301 via the withdrawal of the last expansion control member 311. The nose cone 322 and the retaining member 321 can be withdrawn or retracted proximally relative to the valve via distal to proximal movement of the inner shaft 320 and/or the outer shaft 307. As discussed above with reference to FIG. 2, the retraction of the inner shaft 320 can be controlled via one or more knob or actuators on a handle of the delivery apparatus 301 or by manual withdrawal by the surgeon.

[0195] In some examples where the frame is partially self-expandable, one or more actuators and/or support members (such as for example, such actuator members 208 and/or support members 209 described above with respect to FIG. 2) can remain attached the prosthetic valve 300 after removal of the final expansion control member 311. In such examples, the one or more actuators and/or support members can be detached from the prosthetic valve 300 after the valve is transitioned to the fully expanded state. The nose cone 322 and the retaining member 321 can then be withdrawn or retracted proximally relative to the valve via distal to proximal movement of the inner shaft 320 and/or the outer shaft 307 via one or more knob or actuators on a handle of the delivery apparatus 301 or by manual withdrawal by the surgeon.

[0196] In the example shown in FIGS. 5A-5E, the delivery apparatus 301 includes four expansion control members 311 and four corresponding axial sleeves 360 on the outer skirt 303 of the prosthetic valve 300, which can produce three steps or phases in the gradual radial expansion of the prosthetic valve. As discussed above with reference to FIGS. 4 A and 4B, in the present example, the axial sleeves 360 have an uneven distribution or arrangement on the outer skirt 303, which enables approximately a first third of the outer skirt to be released in the first step of radial expansion, approximately a second third of the outer skirt to be released in the second step of approximately, and a final third of the outer skirt to be released in the third step of radial expansion.

[0197] Specifically, removal of a first expansion control member causes two sections of outer skirt to be released is the first step of radial expansion, as in the illustrated example of FIG. 5B where the expansion control member 311c is removed and the outer skirt sections 303c and 303d are released. In this example, the axial sleeve 306c is positioned on the outer skirt 303 such that there is smaller distance between the axial sleeve 306c and the axial sleeve 360b (width c) and a smaller distance between the axial sleeve 360c and 360d (width d) relative to the distances between the other axial selves (that is, a distance between the axial sleeves 360b and 360a (width b) and a distance between the axial sleeve 360a and 360d (width a)).

[0198] Accordingly, in the first step of radial expansion a portion of the outer skirt corresponding to widths c + d is released, in the second step of radial expansion a portion of the outer skirt corresponding to the width a is released (when the expansion control member 31 Id is withdrawn), and in the third step of radial expansion a portion of the outer skirt corresponding to the width b is released (when the expansion control member 311a is withdrawn).

[0199] The foregoing example of three-step gradual radial expansion may enable an approximately equal degree of expansion of the prosthetic valve to occur in each step or phase of radial expansion, and enables the gradual expansion to occur a relatively low number of steps, thereby making the process for the surgeon faster and relatively simple to carry out. Further, the three-step gradual radial expansion requires a lower number of components relative to some examples (such as the example discussed below), which may make the prosthetic valve and/or the delivery apparatus less complex and less expensive to manufacture relative to some examples.

[0200] It will be appreciated, however, that the foregoing is merely exemplary and, in some examples, a prosthetic valve can include an outer skirt having different numbers and arrangements or distributions of outer sleeves. For example, an outer skirt of a prosthetic valve can include a greater number of axial sleeves and a delivery apparatus configured for use therewith can include a greater number of expansion control members. In one specific alternate example, an outer skirt can include six axial sleeves and a delivery apparatus can include six expansion control members inserted through the axial sleeves and retained by a distal retaining member of the delivery apparatus. The six axial sleeves can be arranged on the outer skirt such that there is a smaller distance between a first axial sleeve and a second axial sleeve and a smaller distance between the first axial sleeve and a third axial sleeve relative to distances between others of the axial sleeves (which may have approximately equal distances therebetween).

[0201] In this alternate example, a first expansion control member can be removed from the first axial sleeve to free a first fifth of the outer skirt and enable a first step of radial expansion of the prosthetic valve. Subsequently, additional expansion control members can be withdrawn each causing release of an additional fifth of the outer skirt and enabling additional steps of radial expansion, with a total of five steps of radial expansion. Such an example, although requiring additional steps and components, may enable finer control of gradual radial expansion and allow additional opportunities for readjustment of a position of prosthetic valve during the step-wise radial expansion process.

[0202] The foregoing alternate example is merely one additional example and other configurations are possible. For example, the outer skirt can include more or fewer axial sleeves having different arrangements for use with delivery apparatus having a corresponding number of expansion control members or a greater number of expansion control members. In one specific example, the outer skirt can be configured such that the portions of the outer skirt released towards the end of the gradual radial expansion process are smaller relative to portions released in earlier radial expansion steps, to enable finer control and the later steps of radial expansion where the position of the prosthetic valve may not be adjustable by a surgeon due to the degree of radial expansion of the valve. Finer control at the end of the gradual radial expansion process may limit unwanted movement or displacement of the prosthetic valve while the valve is in a radially expanded state.

[0203] Further, in the example of FIGS. 5A-5D, the expansion control members are withdrawn in a manner where a next withdrawn expansion control member is adjacent to the prior withdrawn expansion control member. In alternate methods, the expansion control members can be withdrawn in a different order. For example, the expansion control members can be withdrawn such that a next withdrawn expansion control member is a diametrically opposing filament relative to the prior withdrawn expansion control member.

Delivery Techniques

[0204] As discussed above, once a prosthetic valve (for example, the prosthetic valve 300) is connected to a delivery apparatus (for example, delivery apparatus 201), the prosthetic valve can be placed in a radially compressed state for delivery into a patient’s body. In some examples, the compressed prosthetic valve can be loaded into a delivery capsule of the delivery apparatus or can be maintained in a compressed state without a delivery capsule. Thereafter, the delivery apparatus containing the prosthetic valve can be inserted into the patient’s vasculature and advanced to the desired implantation site (for example, one of the native heart valves). Various delivery techniques for delivering the prosthetic valve to various implantation sites are described below.

[0205] Once the prosthetic valve is positioned at the desired implantation site (and deployed from the delivery capsule if the delivery apparatus includes a delivery capsule), the prosthetic valve can be radially expanded via the step-wise or gradual radial expansion methods described above.

[0206] For implanting a prosthetic valve within the native aortic valve via a transfemoral delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral artery and are advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta. The prosthetic valve is positioned within the native aortic valve and radially expanded (for example, by deploying the prosthetic valve from a sheath to allow the prosthetic valve to self-expand via the step-wise radial expansion methods discussed above). Alternatively, a prosthetic valve can be implanted within the native aortic valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native aortic valve. Alternatively, in a transaortic procedure, a prosthetic valve (on the distal end portion of the delivery apparatus) are introduced into the aorta through a surgical incision in the ascending aorta, such as through a partial J- stemotomy or right parasternal mini-thoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

[0207] For implanting a prosthetic valve within the native mitral valve via a transseptal delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, into the right atrium, across the atrial septum (through a puncture made in the atrial septum), into the left atrium, and toward the native mitral valve. Alternatively, a prosthetic valve can be implanted within the native mitral valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native mitral valve.

[0208] For implanting a prosthetic valve within the native tricuspid valve, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, and into the right atrium, and the prosthetic valve is positioned within the native tricuspid valve. A similar approach can be used for implanting the prosthetic valve within the native pulmonary valve or the pulmonary artery, except that the prosthetic valve is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve/pulmonary artery.

[0209] Another delivery approach is a transatrial approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through an atrial wall (of the right or left atrium) for accessing any of the native heart valves. Atrial delivery can also be made intravascularly, such as from a pulmonary vein. Still another delivery approach is a transventricular approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through the wall of the right ventricle (typically at or near the base of the heart) for implanting the prosthetic valve within the native tricuspid valve, the native pulmonary valve, or the pul monary artery. [0210] In all delivery approaches, the delivery apparatus can be advanced over a guidewire previously inserted into a patient’s vasculature. Moreover, the disclosed delivery approaches are not intended to be limited. Any of the prosthetic valves disclosed herein can be implanted using any of various delivery procedures and delivery devices known in the art.

[021 1] Any of the systems, devices, apparatuses, etc. herein can be sterilized (for example, with heat/thermal, pressure, steam, radiation, and/or chemicals, etc.) to ensure they are safe for use with patients, and any of the methods herein can include sterilization of the associated system, device, apparatus, etc. as one of the steps of the method. Examples of heat/thermal sterilization include steam sterilization and autoclaving. Examples of radiation for use in sterilization include, without limitation, gamma radiation, ultra-violet radiation, and electron beam. Examples of chemicals for use in sterilization include, without limitation, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization with hydrogen peroxide may be accomplished using hydrogen peroxide plasma, for example.

[0212] The treatment techniques, methods, steps, etc. described or suggested herein or in references incorporated herein can be performed on a living animal or on a non-living simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (for example, with the body parts, tissue, etc. being simulated), etc.

Additional Examples of the Disclosed Technology

[0213] In view of the above described examples 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.

[0214] In view of the many possible examples to which the principles of the disclosed technology may be applied, it should be recognized that the illustrated example are only preferred examples of the disclosed technology and should not be taken as limiting the scope of the claimed subject matter. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

[0215] Example 1. A prosthetic heart valve configured to be transitioned between a radially compressed state and a radially expanded state, the prosthetic heart valve comprising: an at least partially self-expandable annular frame; a valvular structure disposed in an interior of the annular frame; and an outer skirt disposed on an outer surface of the annular frame; wherein the outer skirt comprises a plurality of axial sleeves, wherein each of the plurality of axial sleeves is configured to receive therein a respective expansion control member of a plurality of expansion control members of a delivery apparatus; wherein the plurality of axial sleeves are configured such that, when the plurality of expansion control members are received within the plurality of axial sleeves, radial expansion of the annular frame is limited; and wherein the outer skirt is configured to enable transition of the prosthetic valve from a radially compressed state toward a radially expanded state via withdrawal of the expansion control members from the respective axial sleeves.

[0216] Example 2. The prosthetic valve of any of the examples disclosed herein, particularly example 1, wherein each of the plurality of axial sleeves is formed by a fold in a material of the outer skirt and an attachment line extending from an inflow end portion to an outflow end portion of the outer skirt.

[0217] Example 3. The prosthetic valve of any of the examples disclosed herein, particularly example 2, wherein the attachment line comprises a suture.

[0218] Example 4. The prosthetic valve of any of the examples disclosed herein, particularly example 2, wherein the attachment line comprises a heat weld.

[0219] Example 5. The prosthetic valve of any of the examples disclosed herein, particularly example 2, wherein the attachment line comprises an adhesive.

[0220] Example 6. The prosthetic valve of any of the examples disclosed herein, particularly examples 1-5, wherein each of the plurality of axial sleeves is parallel to a longitudinal axis of the annular frame.

[0221] Example 7. The prosthetic valve of any of the examples disclosed herein, particularly examples 1-6, wherein the plurality of axial sleeves are disposed on an exterior surface of the outer skirt.

[0222] Example 8. The prosthetic valve of any of the examples disclosed herein, particularly examples 1-7, wherein the plurality of axial sleeves have an even distribution around a circumference of the outer skirt. [0223] Example 9. The prosthetic valve of any of the examples disclosed herein, particularly examples 1-7, wherein the plurality of axial sleeves have an uneven distribution around a circumference of the outer skirt.

[0224] Example 10. The prosthetic valve of any of the examples disclosed herein, particularly example 9, wherein the plurality of axial sleeves comprise at a first axial sleeve, a second axial sleeve, and a third axial sleeve, the first axial sleeve disposed between the second axial sleeve and the third axial sleeve; and wherein the uneven distribution of the axial sleeves comprises a first distance between the first axial sleeve and the second axial sleeve and a second distance between the first axial sleeve and the third axial sleeve relative, wherein each of the first distance and the second distance are less than distances between other adjacent ones of the plurality of axial sleeves.

[0225] Example 11. The prosthetic valve of any of the examples disclosed herein, particularly example 10, wherein a sum of the first distance and the second distance is about equal to each of the distances between the other adjacent ones of the plurality of axial sleeves.

[0226] Example 12. The prosthetic valve of any of the examples disclosed herein, particularly examples 10 or 1 1 , wherein the plurality of axial sleeves comprise a fourth axial sleeve, the fourth axial sleeve being disposed between the second axial sleeve and the third axial sleeve; and wherein each of a fourth distance between the fourth axial sleeve and the second axial sleeve and a fifth distance between the fourth axial sleeve and the third axial sleeve are equal to the third distance.

[0227] Example 13. The prosthetic valve of any of the examples disclosed herein, particularly example 12, wherein the outer skirt is configured such that, when a first expansion control member is withdrawn from the first axial sleeve, a first portion of the outer skirt is released and results in a first step of radial expansion of the prosthetic valve.

[0228] Example 14. The prosthetic valve of any of the examples disclosed herein, particularly example 13, wherein the outer skirt is further configured such that, after withdrawal of the first expansion control member, when a second expansion control member is withdrawn from one of the second axial sleeve or the third axial sleeve, a second portion of the outer skirt is released and results in a second step of radial expansion of the prosthetic valve.

[0229] Example 15. The prosthetic valve of any of the examples disclosed herein, particularly example 14, wherein the outer skirt is further configured such that, after withdrawal of the first expansion control member and the second expansion control member, when a third expansion control member is withdrawn from the fourth axial sleeve, a third portion of the outer skirt is released and results in a third step of radial expansion of the prosthetic valve.

[0230] Example 16. The prosthetic valve of any of the examples disclosed herein, particularly example 15, wherein the first step of radial expansion results in transition of the prosthetic valve from the radially compressed state to a first partially radially expanded state, and the second step of radial expansion results in transition of the prosthetic valve from the first partially expanded state to a second partially expanded state.

[0231] Example 17. The prosthetic valve of any of the examples disclosed herein, particularly example 16, wherein the prosthetic valve has an initial dimeter in the radially compressed state, a first diameter in the first partially expanded state, and a second diameter in the second partially expanded state, wherein the first diameter is greater than the initial diameter, and the second diameter is greater than the first diameter.

[0232] Example 18. The prosthetic valve of any of the examples disclosed herein, particularly example 17, wherein the annular frame comprises a fully self-expandable frame, and wherein the third step of radial expansion results in transition of the prosthetic valve from the second partially expanded state to a fully expanded state, the prosthetic valve having a third diameter in the fully expanded state, wherein the third diameter is greater than the second diameter.

[0233] Example 19. The prosthetic valve of any of the examples disclosed herein, particularly example 18, wherein the prosthetic valve is configured such that, after withdrawal of the first expansion control member, the second filament, and third expansion control member, when a fourth expansion control member is withdrawn from the other one of the third axial sleeve or the second axial sleeve, the prosthetic valve is released from the delivery apparatus. [0234] Example 20. The prosthetic valve of any of the examples disclosed herein, particularly example 17, wherein the annular frame is a partially self-expandable frame, and wherein the third step of radial expansion results in transition of the prosthetic valve from the second partially expanded state to a third partially expanded state, the prosthetic valve having a third diameter in the third partially expanded state, wherein the third diameter is greater than the second diameter.

[0235] Example 21. The prosthetic valve of any of the examples disclosed herein, particularly example 20, wherein the partially self-expandable frame is configured to be further expanded via one or more actuators of the delivery apparatus, and the prosthetic valve is configured to be transitioned from the third partially expanded state to the fully expanded state via actuation of the one or more actuators in a fourth step of radial expansion of the prosthetic valve, the prosthetic valve having a fourth diameter in the fully expanded state, wherein the fourth diameter is greater than the third diameter.

[0236] Example 22. The prosthetic valve of any of the examples disclosed herein, particularly example 21, wherein the prosthetic valve is further configured such that, after withdrawal of the first expansion control member, the second filament, and third expansion control member, when a fourth expansion control member is withdrawn from the other one of the third axial sleeve or the second axial sleeve and the one are more actuators are detached from the annular frame, the prosthetic valve is released from the delivery apparatus.

[0237] Example 23. The prosthetic valve of any of the examples disclosed herein, particularly examples 1-22, wherein the outer skirt is comprised of fabric.

[0238] Example 24. The prosthetic valve of any of the examples disclosed herein, particularly example 23, wherein the fabric comprises a polyethylene terephthalate fabric.

[0239] Example 25. The prosthetic valve of any of the examples disclosed herein, particularly examples 1-24, wherein each of the axial sleeves has that is greater than a diameter of the expansion control member.

[0240] Example 26. The prosthetic valve of any of the examples disclosed herein, particularly examples 1-25, wherein a circumference of the outer skirt corresponds to a circumference of the annular frame when the prosthetic valve is in a fully radially expanded state. [0241] Example 27. The prosthetic valve of any of the examples disclosed herein, particularly example 1-26, wherein the prosthetic heart valve is configured to enable user- controlled step-wise transition from the radially compressed state toward the radially expanded state via withdrawal of each of the expansion control members from the respective axial sleeve.

[0242] Example 28. The prosthetic valve of any of the examples disclosed herein, particularly examples 1-27, wherein the prosthetic heart valve is configured to enable user- controlled gradual transition from the radially compressed state toward the radially expanded state via withdrawal of each of the expansion control members from the respective axial sleeve.

[0243] Example 29. The prosthetic valve of any of the examples disclosed herein, particularly examples 1-28, further comprising a valvular structure disposed on an interior of the annular frame.

[0244] Example 30. The prosthetic valve of any of the examples disclosed herein, particularly examples 1-29, wherein the frame comprises a plurality of interconnected stmts and the outer skirt is secured to at least a portion of the plurality of interconnected stmts.

[0245] Example 31. A prosthetic heart valve delivery system comprising: (i) a prosthetic heart valve configured to transition between a radially compressed configuration and a radially expanded configuration, the prosthetic heart valve comprising: an at least partially self-expandable annular frame; and an outer skirt disposed on an outer surface of the frame, wherein the outer skirt comprises a plurality of axial sleeves disposed on an outer surface thereof; and (ii) a delivery apparatus comprising: a plurality of expansion control members, wherein each of the plurality of axial sleeves is configured to receive at least one expansion control member therethrough; a retaining member configured to releasably retain a distal portion of each of the plurality of expansion control members; and a delivery shaft configured to have at least a proximal portion of each of the plurality of expansion control members extend therein; wherein the prosthetic heart valve and the delivery apparatus are configured such that, when the plurality of expansion control members are extended through the plurality of axial sleeves, the distal portions of the plurality of expansion control members are retained by the distal member, and the proximal portions of each of the plurality of expansion control members extend into the delivery apparatus, the plurality of expansion control members limit radial expansion of the frame.

[0246] Example 32. The prosthetic heart valve delivery system of any of the examples disclosed herein, particularly example 31, wherein prosthetic heart valve delivery system is configured for step-wise transitioning of the prosthetic heart valve from the radially compressed configuration toward the radially expanded configuration via, for each of the plurality of expansion control members sequentially, release of the distal portion of a expansion control member from the distal member and withdrawal of the expansion control member through a respective one of the plurality of axial sleeves.

[0247] Example 33. The prosthetic heart valve delivery system of any of the examples disclosed herein, particularly example 32, wherein the prosthetic heart valve delivery system is further configured such that the withdrawal of each expansion control member causes release of a respective portion of the outer skirt and enables the at least partially selfexpandable annular frame to radially expand to a diameter defined at least in part by the released portion of the outer skirt.

[0248] Example 34. The prosthetic heart valve delivery system of any of the examples disclosed herein, particularly examples 31 -33, wherein the retaining member comprises a plurality of apertures, and wherein each of the plurality of apertures is configured to receive the distal portion of at least one of the plurality of expansion control members therein.

[0249] Example 35. The prosthetic heart valve delivery system of any of the examples disclosed herein, particularly example 34, wherein the plurality of apertures are disposed proximate to the perimeter of the retaining member, and wherein each aperture is spaced equidistant relative to other adjacent ones of the plurality of apertures.

[0250] Example 36. The prosthetic heart valve delivery system of any of the examples disclosed herein, particularly examples 34 or 35, wherein the plurality of expansion control members comprise a plurality of release wires, and wherein each of the plurality of apertures is configured to receive a distal end of a release wire.

[0251] Example 37. The prosthetic heart valve delivery system of any of the examples disclosed herein, particularly example 36, wherein each of the plurality of apertures includes an opening on the proximal face of the retaining member and a closure on a distal face of the retaining member, and wherein the closure on the distal face of the retaining member is configured to limit axial movement of the control wire in the proximal to distal direction when the distal end of the control wire is received within the respective aperture.

[0252] Example 38. The prosthetic heart valve delivery system of either of any of the examples disclosed herein, particularly example 36 or 37, wherein each of the plurality of control wires comprises a metallic material.

[0253] Example 39. The prosthetic heart valve delivery system of any of the examples disclosed herein, particularly example 38, wherein each of the plurality of control wires is further comprises a biocompatible coating.

[0254] Example 40. The prosthetic heart valve delivery system of any of the examples disclosed herein, particularly examples 36-39, wherein the plurality of control wires have sufficient material strength to resist an outward radial force exerted thereon by the frame when the prosthetic valve is in the radially compressed configuration.

[0255] Example 41. The prosthetic heart valve delivery system of any of the examples disclosed herein, particularly examples 36-40, wherein a proximal end portion of each of the plurality of control wires is configured to have a pulling force applied thereto to cause the respective control wire to move in a distal to proximal direction, and thereby result in release of the distal end of the control wire from the retaining member, withdrawal of the control wire from a respective axial sleeve, release of a respective portion of the outer skirt, and radial expansion of the prosthetic valve to a diameter defined at least in part by the released portion of the outer skirt.

[0256] Example 42. The prosthetic heart valve delivery system of any of the examples disclosed herein, particularly examples 34 or 35, wherein the plurality of expansion control members comprise a plurality of release tethers, and wherein each of the plurality of apertures is configured to receive a distal portion of a release tether.

[0257] Example 43. The prosthetic heart valve delivery system of any of the examples disclosed herein, particularly example 42, wherein each of the plurality of apertures includes a first opening on the proximal face of the retaining member and a second opening on a distal face of the retaining member. [0258] Example 44. The prosthetic heart valve delivery system of any of the examples disclosed herein, particularly example 43, wherein the distal portion comprises a trailing portion that extends from the respective axial sleeve through the first opening and the second opening of a respective aperture and a leading portion that extends from the second opening over an exterior surface of the retaining member and returns through the respective axial sleeve.

[0259] Example 45. The prosthetic heart valve delivery system of any of the examples disclosed herein, particularly example 44, wherein the distal portion comprises a loop through the aperture, and wherein each of the control tethers further comprises a trailing portion and a leading portion, each of the trailing portion and the leading portion extending from the loop through a respective axial sleeve and into the delivery shaft, and wherein a first end portion of the trailing portion and a second end portion of the leading portion each extend through the delivery apparatus.

[0260] Example 46. The prosthetic heart valve delivery system of any of the examples disclosed herein, particularly example 45, wherein the plurality of control tethers have sufficient material strength and is retained at a sufficient tautness by the securing of the first end portion and the second end portion within the delivery apparatus to resist an outward radial force exerted thereon by the frame when the prosthetic valve is in the radially compressed configuration.

[0261] Example 47. The prosthetic heart valve delivery system of either of any of the examples disclosed herein, particularly examples 45 or 46, wherein the second end portion of each of the plurality of control tethers is configured to have a pulling force applied thereto to cause the leading portion of the respective control wire to move in a distal to proximal direction and the trailing portion of the respective control tether to move in a proximal to distal direction, and thereby result in release of the loop from the retaining member, withdrawal of the control tether from a respective axial sleeve, release of a respective portion of the outer skirt, and radial expansion of the prosthetic valve to a diameter defined at least in part by the released portion of the outer skirt. [0262] Example 48. The prosthetic heart valve delivery system of any of the examples disclosed herein, particularly examples 42-47, wherein each of the plurality of release tethers comprises a suture.

[0263] Example 49. The prosthetic heart valve delivery system of any of the examples disclosed herein, particularly example 48, wherein each of the plurality of control tethers comprises a plurality of filaments.

[0264] Example 50. The prosthetic heart valve delivery system of any of the examples disclosed herein, particularly examples 31-49, wherein the delivery apparatus further comprises one or more handle actuators configured to cause release of the distal portions of the expansion control members from the retaining member and withdrawal of the plurality of expansion control members through respective ones of the plurality of axial sleeves, and wherein the withdrawal results in release of a respective portion of the outer skirt and radial expansion of the prosthetic valve to a diameter defined at least in part by the released portion of the outer skirt.

[0265] Example 51. The prosthetic heart valve delivery system of any of the examples disclosed herein, particularly examples 31-50, wherein prosthetic heart valve delivery system is configured to enable user-controlled step-wise transition of the prosthetic heart valve from the radially compressed state toward the radially expanded state via withdrawal of each of the plurality of expansion control members from the respective axial sleeves.

[0266] Example 52. The prosthetic heart valve delivery system of any of the examples disclosed herein, particularly examples 31-51, wherein prosthetic heart valve delivery system is configured to enable user-controlled gradual transition the prosthetic heart valve from the radially compressed state toward the radially expanded state via withdrawal of each of the plurality of expansion control members from the respective axial sleeves.

[0267] Example 53. The prosthetic heart valve delivery system of any of the examples disclosed herein, particularly examples 50-52, wherein the prosthetic heart valve delivery system is configured such that withdrawal of a final one of the plurality of expansion control members from the respective axial sleeve results in the prosthetic heart valve being released from the delivery apparatus. [0268] Example 54. The prosthetic heart valve delivery system of any of the examples disclosed herein, particularly examples 31-52, wherein the delivery apparatus further comprises one or more actuators, and wherein the at least partially self-expandable annular frame is a partially self-expandable frame.

[0269] Example 55. The prosthetic heart valve delivery system of any of the examples disclosed herein, particularly example 54, wherein the prosthetic valve is configured to expand from the radially compressed configuration to a partially radially expanded configuration via withdrawal of the plurality of expansion control members from the respective ones of the plurality of axial sleeves, and the prosthetic valve is further configured to expand from the partially radially expanded configuration to a fully radially expanded configuration via mechanical actuation of the one or more actuators.

[0270] Example 56. The prosthetic heart valve delivery system of any of the examples disclosed herein, particularly examples 54 or 55, wherein the prosthetic heart valve delivery system is configured such that release of the one or more actuators from the frame results in the prosthetic heart valve being released from the delivery apparatus.

[0271] Example 57. A delivery apparatus configured for step-wise transitioning of a prosthetic heart valve from a radially compressed configuration to a radially expanded configuration, the prosthetic heart valve comprising an at least partially self-expandable annular frame having a valvular structure disposed in an interior of the frame, and an outer skirt disposed on an outer surface of the frame and comprising a plurality of axial sleeves, the delivery apparatus comprising: a plurality of expansion control members, wherein each of the plurality of expansion control members is configured to extend through one of the plurality of axial sleeves of the outer skirt; a retaining member configured to releasably retain a distal portion of each of the plurality of expansion control members; and a delivery shaft, wherein at least a proximal portion of each of the plurality of expansion control members extend through the delivery shaft; wherein the delivery apparatus is configured such that, when the plurality of expansion control members are extended through the plurality of axial sleeves and the distal portions of the plurality of expansion control members are retained by the distal member, the plurality of expansion control members limit radial expansion of the frame; and wherein the delivery apparatus is configured for the step- wise transitioning of the prosthetic heart valve from the radially compressed configuration toward the radially expanded configuration via successive withdrawal of each of the plurality of expansion control members from respective ones of the plurality of axial sleeves.

[0272] Example 58. The delivery apparatus of any of the examples disclosed herein, particularly example 57, wherein the delivery apparatus is further configured such that, during the transitioning of the prosthetic heart valve from the radially compressed configuration to the radially expanded configuration, the retaining member is distal relative to the delivery shaft and the prosthetic heart valve is disposed between the distal member and a distal end of the delivery shaft.

[0273] Example 59. The delivery apparatus of any of the examples disclosed herein, particularly examples 57 or 58, wherein the delivery apparatus is further configured such that the withdrawal of each expansion control member causes release of a respective portion of the outer skirt and enables the at least partially self-expandable annular frame to radially expand to a diameter defined at least in part by the released portion of the outer skirt.

[0274] Example 60. The delivery apparatus of any of the examples disclosed herein, particularly examples 57-59, wherein the retaining member comprises a plurality of apertures, and wherein each of the plurality of apertures is configured to receive the distal portion of at least one of the plurality of expansion control members therein.

[0275] Example 61. The delivery apparatus of any of the examples disclosed herein, particularly example 60, wherein the plurality of apertures are disposed proximate to the perimeter of the retaining member.

[0276] Example 62. The delivery apparatus of any of the examples disclosed herein, particularly examples 60 or 61, wherein each of the apertures is spaced equidistant relative to other adjacent ones of the plurality of apertures.

[0277] Example 63. The delivery apparatus of any of the examples disclosed herein, particularly examples 57-62, wherein the plurality of expansion control members comprise a plurality of control wires, and wherein each of apertures of the retaining member is configured to receive a distal end of a control wire.

[0278] Example 64. The delivery apparatus of any of the examples disclosed herein, particularly example 63, wherein a proximal end portion of each of the plurality of control wires is configured to have a pulling force applied thereto to cause the respective control wire to move in a distal to proximal direction, and thereby result in release of the distal end of the control wire from the retaining member, withdrawal of the control wire from a respective axial sleeve, release of a respective portion of the outer skirt, and radial expansion of the prosthetic valve to a diameter defined at least in part by the released portion of the outer skirt.

[0279] Example 65. The delivery apparatus of any of the examples disclosed herein, particularly example 64, further comprising a handle coupled to the delivery shaft, the handle comprising one or more actuators, wherein at least one of the actuators is configured to apply the pulling force on one or more of the proximal end portions of the plurality of control wires.

[0280] Example 66. The delivery apparatus of any of the examples disclosed herein, particularly examples 57-62, wherein the plurality of expansion control members comprise a plurality of tethers, and wherein each of the apertures of the retaining member is configured to receive a distal loop portion of one or more of the tethers.

[0281] Example 67. The delivery apparatus of any of the examples disclosed herein, particularly example 66, wherein each of the control tethers further comprises a trailing portion and a leading portion, each of the trailing portion and the leading portion extending from the distal loop portion through a respective axial sleeve and into the delivery shaft, and wherein a first end portion of the trailing portion and a second end portion of the leading portion are each extend through the delivery apparatus.

[0282] Example 68. The delivery apparatus of any of the examples disclosed herein, particularly example 67, wherein the second end portion of each of the plurality of control tethers is configured to have a pulling force applied thereto to cause the leading portion of the respective control wire to move in a distal to proximal direction and the trailing portion of the respective control tether to move in a proximal to distal direction, and thereby result in release of the distal loop portion from the retaining member, withdrawal of the control tether from a respective axial sleeve, release of a respective portion of the outer skirt, and radial expansion of the prosthetic valve to a diameter defined at least in part by the released portion of the outer skirt.

[0283] Example 69. The delivery apparatus of any of the examples disclosed herein, particularly example 68, further comprising a handle coupled to the delivery shaft, the handle comprising one or more actuators, wherein at least one of the actuators is configured to apply the pulling force on one or more of the second end portions of the plurality of control tethers.

[0284] Example 70. A method for implanting a prosthetic heart valve, the prosthetic heart valve comprising an at least partially self-expandable frame and an outer skirt disposed on an exterior surface of the frame, the outer skirt comprising a plurality of axial sleeves, the method comprising: introducing a distal end portion of a delivery apparatus into a patient’s vasculature, wherein the prosthetic heart valve is retained in a radially compressed configuration within a delivery capsule of the distal end portion of the delivery apparatus, wherein the outer skirt has at least one of a plurality of expansion control members of the delivery apparatus inserted through each of the plurality of axial sleeves, wherein a distal portion of each of the plurality of expansion control members is releasably coupled to a retaining member that is distal relative to the prosthetic heart valve, wherein the prosthetic heart valve has an initial diameter in the radially compressed configuration; advancing the distal end portion of the delivery apparatus and the prosthetic heart valve through the vasculature toward an implantation site; deploying the prosthetic heart valve from the delivery capsule; and after deploying the prosthetic heart valve from the delivery capsule, limiting radial expansion the prosthetic heart valve by maintaining a position of each of the plurality of expansion control members within the respective axial sleeves.

[0285] Example 71. The method of any of the examples disclosed herein, particularly example 70, further comprising applying a force in a distal to proximal direction on a first expansion control member of the plurality of expansion control members to cause release of the distal portion thereof from the retaining member and withdrawal of the first expansion control member through the respective axial sleeve, the withdrawal of the first expansion control member resulting in release of a first portion of the outer skirt and radial expansion of the prosthetic valve from the initial diameter to a first diameter in a first step of radial expansion.

[0286] Example 72. The method of any of the examples disclosed herein, particularly example 71, further comprising applying a force on successive ones of the plurality of expansion control members in the distal to proximal direction to cause release of the distal portions thereof from the retaining member and withdrawal of the expansion control member through the respective axial sleeve, the withdrawal of each expansion control member resulting in release of a corresponding portion of the outer skirt and radial expansion of the prosthetic valve from the first diameter to successively larger diameters in additional steps of radial expansion.

[0287] Example 73. The method of any of the examples disclosed herein, particularly example 72, further comprising applying a force on a last expansion control member of the plurality of expansion control members in the distal to proximal direction to cause release of the distal portion thereof from the retaining member and withdrawal of the last expansion control member through the respective axial sleeve.

[0288] Example 74. The method of any of the examples disclosed herein, particularly example 73, wherein the withdrawal of the last expansion control member results in detachment of the prosthetic valve from the delivery apparatus.

[0289] Example 75. The method of any of the examples disclosed herein, particularly example 73, wherein the at least partially self-expandable frame is a partially expandable frame releasably coupled to one or more actuators of the delivery apparatus, and the method further comprises: actuating the one or more actuators to cause the prosthetic heart valve to radially expand into a fully radially expanded configuration in a last step of radial expansion; and releasing the one or more actuators from the frame of the delivery apparatus to detach the prosthetic valve from the delivery apparatus.

[0290] Example 76. A method of gradually radially expanding an at least partially selfexpandable prosthetic valve, the method comprising: positioning the prosthetic valve at a desired location within a patient’s body while the prosthetic valve is an a radially compressed state, wherein radial expansion of the prosthetic valve in the radially compressed state is limited by a plurality of expansion control members inserted through a plurality of axial sleeves on an outer surface of the prosthetic valve; and sequentially withdrawing each of the plurality of expansion control members to release a corresponding portion of the prosthetic valve and cause radial expansion of the valve to progressively larger diameters until the prosthetic valve reaches a maximum radially self-expanded state.

[0291] Example 77. A method of preparing an at least partially self-expandable prosthetic valve for implantation, the method comprising: radially compressing the prosthetic valve from a radially expanded state to a radially compressed state; maintaining the prosthetic valve in the radially compressed state, the maintain comprising applying a resistive force on the prosthetic valve via a plurality of expansion control members inserted through a plurality of axial sleeves on an outer surface of the prosthetic valve.

[0292] Example 78. The method of any of the examples disclosed herein, particularly example 77, further comprising loading the prosthetic valve into a delivery capsule, the maintaining of the prosthetic valve in the radially compressed state further comprising applying a resistive force on the prosthetic valve via a wall of the delivery capsule.

[0293] Example 79. An outer skirt for an at least partially self-expandable prosthetic heart valve, the outer skirt comprising: a fabric body configured to have a cylindrical configuration and to be attached to an outer surface of a frame of the prosthetic heart valve; a plurality of axial sleeves disposed on a surface of the fabric body and configured to be disposed on an exterior surface of the prosthetic heart valve when the fabric body is attached to the outer surface of the frame; wherein the plurality of axial sleeves are configured to receive a plurality of expansion control members of a delivery apparatus therethrough; and wherein the outer skirt is configured to enable step- wise radial expansion of the prosthetic heart valve via successive withdrawal of each of the plurality of expansion control members from the respective axial sleeves.

[0294] Example 80. The prosthetic valve or the outer skirt of any of the examples disclosed herein, particularly examples 1 and 79, wherein each of the plurality of axial sleeves is a tubular body attached to a cylindrical main body of the outer skirt.

[0295] Example 81. An assembly comprising: a prosthetic heart valve configured to transition between a radially compressed configuration and a radially expanded configuration, the prosthetic heart valve comprising: an at least partially self-expandable annular frame having a valvular structure disposed in an interior of the frame; and an outer skirt disposed on an outer surface of the frame, wherein the outer skirt comprises a plurality of axial sleeves; and a delivery apparatus comprising: a plurality of expansion control members, wherein each of the plurality of axial sleeves is configured to receive at least one of the expansion control members therethrough; a retaining member configured to releasably retain a distal portion of each of the expansion control members; and a delivery shaft configured to receive at least a proximal portion of each of the plurality of expansion control members extend therein; wherein the prosthetic heart valve and the delivery apparatus are configured such that, when the plurality of expansion control members are extended through the plurality of axial sleeves and the distal portions of the plurality of expansion control members are retained by the retaining member, the plurality of expansion control members limit radial expansion of the frame.

[0296] Example 82. The assembly of any example disclosed herein, particularly example

81, wherein the prosthetic heart valve and the delivery apparatus are configured for step- wise transitioning of the prosthetic heart valve from the radially compressed configuration toward the radially expanded configuration by sequentially withdrawing the expansion control members from the retaining member and respective axial sleeves.

[0297] Example 83. The assembly of any example disclosed herein, particularly example

82, wherein the prosthetic heart valve and the delivery apparatus are further configured such that the withdrawal of the expansion control members causes release of a respective portion of the outer skirt and results in the annular frame radially expanding to a diameter defined at least in part by the released portion of the outer skirt.

[0298] Example 84. The assembly of any example disclosed herein, particularly either of examples 82 or 83, wherein the at least partially self-expandable annular frame is a fully selfexpandable frame, and wherein the prosthetic heart valve and the delivery apparatus are configured such that withdrawal of a final one of the plurality of expansion control members from a respective axial sleeve results in the prosthetic heart valve being released from the delivery apparatus.

[0299] Example 85. The assembly of any example disclosed herein, particularly either of examples 82 or 83, wherein the at least partially self-expandable annular frame is a partially self-expandable frame, and wherein the delivery apparatus further comprises one or more actuators configured to expand the partially self-expandable frame from a partially radially expanded configuration to the radially expanded configuration via mechanical actuation.

[0300] Example 86. The assembly of any example disclosed herein, particularly example 85, wherein the prosthetic heart valve and the delivery apparatus are configured such that release of the one or more actuators from the frame results in the prosthetic heart valve being released from the delivery apparatus. [0301] Example 87. The assembly of any example disclosed herein, particularly of any one of examples 81-86, wherein the retaining member comprises a plurality of apertures, and wherein each of the plurality of apertures is configured to receive the distal portion of at least one of the plurality of expansion control members therein.

[0302] Example 88. The assembly of any example disclosed herein, particularly example 87, wherein the plurality of expansion control members comprise a plurality of control wires, and wherein each of the plurality of apertures includes an opening on the proximal face of the retaining member which is configured to receive a distal end of one or more of the control wires.

[0303] Example 89. The assembly of any example disclosed herein, particularly example 87, wherein the plurality of expansion control members comprise a plurality of control tethers, and wherein each of the plurality of apertures includes a first opening on the proximal face of the retaining member and a second opening on a distal face of the retaining member and is configured to receive a distal portion of a one of the control tethers.

[0304] Example 90. The assembly of any example disclosed herein, particularly example 89, wherein the distal portion comprises a loop extending through the aperture, and wherein each of the tethers further comprises a trailing portion and a leading portion, each of the trailing portion and the leading portion extending from the loop through a respective one of the axial sleeves and into the delivery shaft.

[0305] Example 91. The assembly or the delivery apparatus of any example disclosed herein, particularly examples 57-64, 66-68, and 81-90, further comprising a handle coupled to the delivery shaft, the handle comprising one or more actuators, wherein at least one of the actuators is configured to retract a respective proximal portion of one or more of the expansion control members for withdrawal of the one or more expansion control member from a respective one of the axial sleeves.

[0306] Example 92. A method comprising sterilizing a prosthetic valve, a system, or a delivery apparatus of any of the examples disclosed herein, particularly examples 1-91.

[0307] The features described herein with regard to any example can be combined with other features described in any one or more of the other examples, unless otherwise stated. For example, any one or more of the features of one prosthetic valve can be combined with any one or more features of another prosthetic valve. As another example, any one or more features of one delivery apparatus can be combined with any one or more features of another delivery apparatus.

[0308] In view of the many possible ways in which the principles of the disclosure may be applied, it should be recognized that the illustrated configurations depict examples of the disclosed technology and should not be taken as limiting the scope of the disclosure nor the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

We claim:

1. A prosthetic heart valve configured to be transitioned between a radially compressed state and a radially expanded state, the prosthetic heart valve comprising: an at least partially self-expandable annular frame; a valvular structure disposed in an interior of the annular frame; and an outer skirt disposed on an outer surface of the annular frame; wherein the outer skirt comprises a plurality of axial sleeves, wherein each of the plurality of axial sleeves is configured to receive therein at least one expansion control member of a plurality of expansion control members of a delivery apparatus; wherein the plurality of axial sleeves are configured such that, when the plurality of expansion control members are received within the plurality of axial sleeves, radial expansion of the annular frame is limited; and wherein the outer skirt is configured to enable transition of the prosthetic valve from a radially compressed state toward a radially expanded state via withdrawal of the expansion control members from the respective axial sleeves.

2. The prosthetic valve of claim 1, wherein each of the plurality of axial sleeves is formed by a fold in a material of the outer skirt and an attachment line extending from an inflow end portion to an outflow end portion of the outer skirt.

3. The prosthetic valve of claim 2, wherein the attachment line comprises one or more of a suture, a heat weld, or an adhesive.

4. The prosthetic valve of claim 1, wherein each of the plurality of axial sleeves is a tubular body attached to a cylindrical main body of the outer skirt.

5. The prosthetic valve of any one of claims 1-4, wherein each of the plurality of axial sleeves is parallel to a longitudinal axis of the annular frame.

6. The prosthetic valve of any one of claims 1-5, wherein the plurality of axial sleeves are disposed on an exterior surface of the outer skirt.

7. The prosthetic valve of any one of claims 1-6, wherein the plurality of axial sleeves have an even distribution around a circumference of the outer skirt.

8. The prosthetic valve of any one of claims 1-6, wherein the plurality of axial sleeves have an uneven distribution around a circumference of the outer skirt.

9. The prosthetic valve of claim 8, wherein the plurality of axial sleeves comprise at a first axial sleeve, a second axial sleeve, and a third axial sleeve, the first axial sleeve disposed between the second axial sleeve and the third axial sleeve; and wherein the uneven distribution of the axial sleeves comprises a first distance between the first axial sleeve and the second axial sleeve, and a second distance between the first axial sleeve and the third axial sleeve, wherein each of the first distance and the second distance are less than distances between other adjacent ones of the plurality of axial sleeves.

10. The prosthetic valve of claim 9, wherein a sum of the first distance and the second distance is about equal to each of the distances between the other adjacent ones of the plurality of axial sleeves.

11. The prosthetic valve of any one of claims 1-10, wherein a circumference of the outer skirt corresponds to a circumference of the annular frame when the prosthetic valve is in a fully radially expanded state.

12. The prosthetic valve of any one of claims 1-11, wherein the frame comprises a plurality of interconnected struts and the outer skirt is secured to at least a portion of the plurality of interconnected struts.

13. The prosthetic valve of any one of claims 1-12, wherein the frame is fully selfexpandable and the withdrawal of the expansion control members from respective axial sleeves transitions the prosthetic valve from the radially compressed state to the radially expanded state.

14. The prosthetic valve of any one of claims 1-12, wherein the frame is partially self-expandable and the withdrawal of the expansion control members from respective axial sleeves transitions the prosthetic valve from the radially compressed state to a partially radially expanded state, and wherein the prosthetic valve is configured to be transitioned from the partially radially expanded state to a fully radially expanded state via a mechanical actuator.

15. An assembly comprising: a prosthetic heart valve configured to transition between a radially compressed configuration and a radially expanded configuration, the prosthetic heart valve comprising: an at least partially self-expandable annular frame having a valvular structure disposed in an interior of the frame; and an outer skirt disposed on an outer surface of the frame, wherein the outer skirt comprises a plurality of axial sleeves; and a delivery apparatus comprising: a plurality of expansion control members, wherein each of the plurality of axial sleeves is configured to receive at least one of the expansion control members therethrough; a retaining member configured to releasably retain a distal portion of each of the expansion control members; and a delivery shaft configured to receive at least a proximal portion of each of the plurality of expansion control members extend therein; wherein the prosthetic heart valve and the delivery apparatus are configured such that, when the plurality of expansion control members are extended through the plurality of axial sleeves and the distal portions of the plurality of expansion control members are retained by the retaining member, the plurality of expansion control members limit radial expansion of the frame.

16. The assembly of claim 15, wherein the prosthetic heart valve and the delivery apparatus are configured for step-wise transitioning of the prosthetic heart valve from the radially compressed configuration toward the radially expanded configuration by sequentially withdrawing the expansion control members from the retaining member and respective axial sleeves.

17. The assembly of claim 16, wherein the prosthetic heart valve and the delivery apparatus are further configured such that the withdrawal of the expansion control members causes release of a respective portion of the outer skirt and results in the annular frame radially expanding to a diameter defined at least in part by the released portion of the outer skirt.

18. The assembly of either of claim 16 or claim 17, wherein the at least partially self-expandable annular frame is a fully self-expandable frame, and wherein the prosthetic heart valve and the delivery apparatus are configured such that withdrawal of a final one of the plurality of expansion control members from a respective axial sleeve results in the prosthetic heart valve being released from the delivery apparatus.

19. The assembly of either of claim 16 or claim 17, wherein the at least partially self-expandable annular frame is a partially self-expandable frame, and wherein the delivery apparatus further comprises one or more actuators configured to expand the partially selfexpandable frame from a partially radially expanded configuration to the radially expanded configuration via mechanical actuation.

20. The assembly of claim 19, wherein the prosthetic heart valve and the delivery apparatus are configured such that release of the one or more actuators from the frame results in the prosthetic heart valve being released from the delivery apparatus.

21. The assembly of any one of claims 15-20, wherein the retaining member comprises a plurality of apertures, and wherein each of the plurality of apertures is configured to receive the distal portion of at least one of the plurality of expansion control members therein.

22. The assembly of claim 21, wherein the plurality of expansion control members comprise a plurality of control wires, and wherein each of the plurality of apertures includes an opening on the proximal face of the retaining member which is configured to receive a distal end of one or more of the control wires.

23. The assembly of claim 21, wherein the plurality of expansion control members comprise a plurality of control tethers, and wherein each of the plurality of apertures includes a first opening on the proximal face of the retaining member and a second opening on a distal face of the retaining member and is configured to receive a distal portion of a one of the control tethers.

24. The assembly of claim 23, wherein the distal portion comprises a loop extending through the aperture, and wherein each of the tethers further comprises a trailing portion and a leading portion, each of the trailing portion and the leading portion extending from the loop through a respective one of the axial sleeves and into the delivery shaft.

25. A delivery apparatus configured for step- wise transitioning of a prosthetic heart valve from a radially compressed configuration to a radially expanded configuration, the prosthetic heart valve comprising an at least partially self-expandable annular frame having a valvular structure disposed in an interior of the frame, and an outer skirt disposed on an outer surface of the frame and comprising a plurality of axial sleeves, the delivery apparatus comprising: a plurality of expansion control members, wherein each of the plurality of expansion control members is configured to extend through one of the plurality of axial sleeves of the outer skirt; a retaining member configured to releasably retain a distal portion of each of the plurality of expansion control members; and a delivery shaft, wherein at least a proximal portion of each of the plurality of expansion control members extend through the delivery shaft; wherein the delivery apparatus is configured such that, when the plurality of expansion control members are extended through the plurality of axial sleeves and the distal portions of the plurality of expansion control members are retained by the distal member, the plurality of expansion control members limit radial expansion of the frame; and wherein the delivery apparatus is configured for the step- wise transitioning of the prosthetic heart valve from the radially compressed configuration toward the radially expanded configuration via successive withdrawal of each of the plurality of expansion control members from respective ones of the plurality of axial sleeves.

26. The delivery apparatus of claim 25, further comprising a handle coupled to the delivery shaft, the handle comprising one or more actuators, wherein at least one of the actuators is configured to retract a respective proximal portion of one or more of the expansion control members for withdrawal of the one or more expansion control member from respective ones of the axial sleeves.

27. The delivery apparatus of either of claim 25 or claim 26, wherein the retaining member comprises a plurality of apertures, and wherein each of the plurality of apertures is configured to receive the distal portion of at least one of the plurality of expansion control members therein.

28. The delivery apparatus of claim 27, each or the apertures is spaced equidistant relative to other adjacent ones of the plurality of apertures.

29. The delivery apparatus of any either of claim 27 or claim 28, wherein the plurality of expansion control members comprise a plurality of control wires, and wherein each of the apertures of the retaining member is configured to receive a distal end of one or more of the control wires.

30. The delivery apparatus of either of claim 27 or claim 28, wherein the plurality of expansion control members comprise a plurality of tethers, and wherein each of the apertures of the retaining member is configured to receive a distal loop portion of one or more of the tethers.