Apparatus and method for monitoring radial expansion of a prosthesis - Patents.com

Abstract

Certain embodiments of the present disclosure relate to a prosthesis. The prosthesis may include a radially compressible and expandable frame and a screw actuator coupled to the frame and configured to rotate to radially expand the frame from a radially compressed state to a radially expanded state. The frame may include two or more pairs of first and second markers. The first and second marker pairs may be circumferentially spaced apart from one another. The first and second markers of each pair may be axially aligned and axially movable relative to one another as the frame radially expands. The positions of the first and second markers may be configured such that a difference in axial distance between each pair of the first and second markers may indicate an evenness of radial expansion of the frame.

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of U.S. Provisional Patent Application No. 63 / 291,172, filed December 17, 2021, which is incorporated by reference in its entirety.

[0002] The present disclosure relates to implantable, radially expandable prostheses, such as prosthetic heart valves, as well as methods, assemblies and devices for delivering, expanding, implanting and deploying such prostheses. [Background technology]

[0003] The human heart can suffer from a variety of valvular diseases that can cause serious malfunctions of the heart, ultimately requiring repair of the native valve or replacement of the native valve with a prosthetic valve. Numerous repair devices (e.g., stents) and prosthetic valves are known, as are numerous methods for implanting such devices and valves in humans. Percutaneous and minimally invasive surgical approaches are used in a variety of procedures to deliver prosthetic medical devices to locations within the body that are not easily accessible by surgery and where access without surgery is desirable. In one specific example, the prosthetic heart valve can be mounted in a crimped state on the distal end of a delivery device and advanced through the patient's vascular system (e.g., through the femoral artery and aorta) to reach the implantation site within the heart. The prosthetic heart valve is then expanded to its functional size, for example by inflating a balloon to which the prosthetic valve is attached, or by activating a mechanical actuator that applies an expansive force to the prosthetic heart valve, or by deploying the prosthetic heart valve from a sheath of a delivery device, allowing it to self-expand to its functional size.

[0004] A prosthetic heart valve that relies on a mechanical actuator for expansion may be referred to as a "mechanically expandable" prosthetic heart valve. Mechanically expandable prosthetic heart valves may provide one or more advantages over self-expandable prosthetic heart valves and over balloon-expandable prosthetic heart valves. For example, mechanically expandable prosthetic heart valves can be expanded to a variety of fully functional operating diameters. Some mechanically expandable prosthetic heart valves can also be compressed (e.g., for repositioning and / or for retrieval) after initial expansion.

[0005] Despite recent advances in percutaneous valve technology, a need remains for improved transcatheter prostheses, such as those that allow for uniform expansion of mechanically expandable prostheses and real-time monitoring of radial expansion of the prosthesis. Summary of the Invention

[0006] The present disclosure relates to methods and devices for treating valvular disease. In particular, the present disclosure is directed to implantable radially expandable prostheses, such as artificial heart valves, as well as methods, assemblies, and apparatus for delivering, expanding, implanting, and deploying such prostheses. More particularly, the present disclosure describes techniques that allow an operator to monitor the radial expansion of the prosthesis under fluoroscopy.

[0007] In one aspect, the prosthesis can include a radially compressible and expandable frame. In addition to these components, the prosthesis can further include one or more of the components disclosed herein.

[0008] In some embodiments, the prosthesis may be a prosthetic heart valve that includes a valve structure (eg, one or more leaflets) disposed within a frame.

[0009] In some embodiments, the prosthetic device can include two or more pairs of a first and a second movable marker circumferentially spaced apart from each other.

[0010] In some embodiments, the first and second movable markers of each pair are axially aligned and axially movable relative to one another such that the axial distance between the first and second movable markers of each pair can change as the frame expands radially.

[0011] In some embodiments, the positions of the first and second movable markers are configured such that a difference between an axial distance of one of the pair of first and second movable markers and an axial distance of the other of the pair of first and second movable markers can indicate a degree of uniformity of radial expansion of the frame.

[0012] In some embodiments, the prosthesis may comprise one or more screw actuators coupled to the frame and configured to rotate to radially expand the frame from a radially compressed state to a radially expanded state.

[0013] In some embodiments, the frame may include a pair of first and second fixed markers that are axially spaced apart from each other by a fixed distance, and a pair of first and second movable markers that are axially movable relative to each other as the frame expands radially such that the distance between the pair of first and second movable markers can be compared to the fixed distance between the pair of first and second fixed markers.

[0014] Certain aspects of the present disclosure relate to a prosthesis including a radially compressible and expandable frame and a screw actuator coupled to the frame and configured to rotate to radially expand the frame from a radially compressed state to a radially expanded state. The frame may include two or more pairs of first and second movable markers. The pairs of first and second movable markers may be circumferentially spaced apart from one another. The first and second movable markers of each pair may be axially aligned and axially movable relative to one another as the frame radially expands, such that the axial distance between the first and second movable markers of each pair may vary. The positions of the first and second movable markers may be configured such that a difference between the axial distance of one of the pairs of first and second movable markers and the axial distance of the other of the pairs of first and second movable markers may indicate an evenness of radial expansion of the frame.

[0015] Certain aspects of the present disclosure relate to another prosthesis including a radially compressible and expandable frame and a screw actuator coupled to the frame and configured to be rotated to radially expand the frame from the radially compressed state to a radially expanded state. The frame can include a pair of first and second fixed markers axially spaced apart from each other by a fixed distance, and a pair of first and second movable markers axially movable relative to each other as the frame radially expands such that a distance between the pair of first and second fixed markers can be compared to a fixed distance between the pair of first and second fixed markers.

[0016] According to certain aspects of the present disclosure, the prosthesis may include a frame that may include multiple pairs of axially extending first and second actuator posts, at least one rod extending through an inner bore of a selected second actuator post and coupled to a selected first actuator post paired with the selected second actuator post, and two or more pairs of first and second movable markers. Each pair of first and second actuator posts may be axially movable relative to one another. Rotation of the rod may be configured to radially expand the frame from a radially compressed state to a radially expanded state. The first movable marker may be located on two or more of the first actuator posts, and the second movable marker may be located on two or more of the second actuator posts paired with the two or more first actuator posts. The first and second movable markers of each pair are spaced apart from one another by an axial distance that decreases as the frame radially expands. The positions of the first and second movable markers may be configured such that a difference between the axial distance of one of the pair of first and second movable markers and the axial distance of the other of the pair of first and second movable markers when the frame is radially expanded may indicate the evenness of the radial expansion of the frame.

[0017] According to certain aspects of the present disclosure, the prosthesis may include a frame including axially extending first and second actuator posts axially movable relative to one another, a rod extending through an inner bore of the second actuator post and coupled to the first actuator post, and a support post extending parallel to the first and second actuator posts. The rod may be configured to rotate to radially expand the frame from a radially compressed state to a radially expanded state. The support post may include a pair of first and second fixed markers axially spaced apart from one another by a fixed distance. The first actuator post may include a first movable marker and the second actuator post may include a second movable marker such that the distance between the first and second movable markers can be compared to a fixed distance between the first and second fixed markers.

[0018] Certain aspects of the present disclosure also relate to prosthetic valves. The prosthetic valve may include an annular frame having an inflow end and an outflow end, and a valve structure mounted within the frame and configured to regulate blood flow from the inflow end to the outflow end. The frame may include a plurality of pairs of axially extending first and second actuator posts. Each pair of the first and second actuator posts may be axially movable relative to one another. The frame may also include at least one rod coupled to a selected first actuator post that extends through an inner bore of the selected second actuator post and pairs with the selected second actuator post. Rotation of the rod may be configured to radially expand the frame from a radially compressed state to a radially expanded state. The frame may further include one or more axially extending support posts. The at least two first actuator posts may include respective first movable markers, and the two second actuator posts paired with the at least two first actuator posts may include respective second movable markers for defining pairs of the first and second movable markers. The first and second movable markers of each pair of movable markers are spaced apart from one another by an axial distance that decreases as the frame expands radially. The positions of the first and second movable markers may be configured such that a difference between the axial distance of one of the pair of movable markers and the axial distance of the other of the pair of movable markers as the frame expands radially may indicate an evenness of radial expansion of the frame. The at least one support post may include first and second fixed markers axially spaced apart from one another by a fixed distance such that the axial distance between each pair of the first and second movable markers as the frame expands radially may be compared to a fixed distance between the first and second fixed markers.

[0019] Certain aspects of the present disclosure also relate to an assembly including a prosthesis having a frame and a delivery device configured to deliver the prosthesis to a target location. The frame may include a plurality of axially extending expansion and locking mechanisms and one or more axially extending support posts. Each expansion and locking mechanism may include a pair of first and second actuator posts axially movable relative to one another and a rod extending through an inner bore of the second actuator post and coupled to the first actuator post. Rotation of the rod may be configured to radially expand the prosthesis from a radially compressed state to a radially expanded state. The at least two expansion and locking mechanisms may include respective pairs of first and second movable markers. The first movable markers may be located on the first actuator posts of the at least two expansion and locking mechanisms, respectively, and the second movable markers may be located on the second actuator posts of the at least two expansion and locking mechanisms, respectively. The positions of the first and second movable markers may be configured such that a difference in axial distance between the respective pairs of the first and second movable markers may indicate an evenness of radial expansion of the frame. The delivery device may include an outer shaft. A distal end portion of the outer shaft may be configured to receive the prosthesis in a radially compressed state. The delivery device may also include at least one actuator assembly extending through the outer shaft and operably connected to the frame, and a handle connected to a proximal end of the outer shaft. The handle may include a first control mechanism configured to be actuated to move the prosthesis out of the distal end of the outer shaft.

[0020] Certain aspects of the present disclosure relate to a method that includes radially expanding a prosthesis from a radially compressed state to a radially expanded state and determining a diameter of the prosthesis as the prosthesis is radially expanded. The frame may include a pair of first and second fixed markers axially spaced apart from each other by a fixed distance and a pair of first and second movable markers axially movable relative to each other as the frame radially expands. Determining the diameter of the prosthesis may include determining a distance between the first and second movable markers based on the fixed distance between the first and second fixed markers.

[0021] Certain aspects of the present disclosure also relate to a method that includes radially expanding a prosthesis from a radially compressed state to a radially expanded state and monitoring the evenness of expansion as the prosthesis is radially expanded. The prosthesis may include a frame that may include two or more pairs of first and second movable markers. Each pair of the first and second movable markers may be axially movable relative to one another as the frame radially expands. Monitoring the evenness of expansion may include detecting a difference in axial distance between each pair of the first and second movable markers. A decrease in the difference may indicate an increase in the evenness of expansion and an increase in the distance may indicate a decrease in the evenness of expansion.

[0022] The above methods can be performed on live animals or on simulations (such as on cadavers, cadaver hearts, anthropomorphic ghosts, simulators (e.g., simulated body parts, hearts, tissues, etc.)).

[0023] In some embodiments, the prosthesis / valve comprises one or more of the components listed in Examples 1-50 described in the "Additional Examples of the Disclosed Technology" section below.

[0024] 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 drawings. [Brief description of the drawings]

[0025] [Figure 1A] FIG. 1A is a perspective view of an example of a prosthetic valve that includes a frame and multiple leaflets attached to the frame. [Figure 1B] FIG. 1B is a perspective view of the prosthetic valve of FIG. 1A having an outer skirt disposed about the frame. [Figure 2A] FIG. 2A is a perspective view of a frame for the prosthetic valve of FIG. 1A. [Figure 2B] FIG. 2B is a front portion of the frame shown in FIG. 2A. [Diagram 3] FIG. 3 is a side view of a delivery device for a prosthetic device, such as a prosthetic valve, according to an example. [Figure 4] FIG. 4 is a perspective view of a portion of the actuator of the prosthetic device of FIGS. 1-2 and an actuator assembly of a delivery device, according to one example. [Diagram 5] FIG. 5 is a perspective view of the actuator and actuator assembly of FIG. 4, with the actuator assembly physically coupled to the actuator. [Figure 6] FIG. 6 is a perspective view of a portion of a prosthetic frame according to another example. [Figure 7] FIG. 7 is a plan view of a portion of the frame of FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0026] General Considerations For purposes of this specification, certain aspects, advantages, and novel features of the disclosed embodiments are described herein. The disclosed methods, apparatus, and systems should not be construed as limiting in any way. Instead, the disclosure is directed to all novel and non-obvious features and aspects of the various disclosed embodiments, both alone and in various combinations with each other and in various subcombinations with each other. The methods, apparatus, and systems are not limited to any particular aspect or feature, or combination thereof, nor do the disclosed embodiments require that any one or more particular advantages exist or problems be solved.

[0027] Although operations in some disclosed embodiments are described in a particular sequential order for convenience of presentation, it should be understood that aspects of the description encompass reordering, unless a particular order is required by specific language set forth below. For example, operations described sequentially may be reordered or performed simultaneously in some cases. Moreover, for purposes of simplicity, the accompanying figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. In addition, the description sometimes uses terms such as "providing" or "achieving" 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 those of ordinary skill in the art.

[0028] As used in this application and claims, the singular forms "a," "an," and "the" include the plural unless the context clearly dictates otherwise. Additionally, the term "includes" means "comprises." Furthermore, the term "coupled" generally means to be physically, mechanically, chemically, magnetically, and / or electrically coupled or connected, and does not exclude the presence of intermediate elements between coupled or associated members, unless specifically stated to the contrary. Additionally, as used herein, "and / or" means not only "and" or "or," but also "and" and "or."

[0029] As used herein, the term "proximal" refers to a position, direction, or portion of a device that is closer to the user and farther away from the implantation site. As used herein, the term "distal" refers to a position, direction, or portion of a device that is farther away from the user and closer to the implantation site. Thus, for example, proximal movement of a device is the movement of the device away from the implantation site and toward the user (e.g., out of the patient's body), while distal movement of a device is the movement of the device away from the user and toward the implantation site (e.g., into the patient's body). The terms "longitudinal" and "axial" refer to axes extending in the proximal and distal directions, unless expressly defined otherwise.

[0030] Directions and other relative references (e.g., inside, outside, upper, lower, etc.) may be used to facilitate discussion of the principles of the drawings and the present specification, but are not intended to be limiting. For example, certain terms may be used, such as "inside," "outside," "top," "down," "interior," and "exterior," and the like. Such terms are used, where applicable, to provide some descriptive clarity with respect to the specifically illustrated embodiments when dealing with relative relationships. However, such terms are not intended to imply absolute relationships, positions, and / or orientations. For example, with respect to an object, an "upper" portion may become a "lower" portion by simply flipping the object over. Nevertheless, it is still the same portion and the object remains the same.

[0031] Overview of the disclosed technology The prosthetic valves disclosed herein may be radially compressible and radially expandable between a radially compressed state and a radially expanded state. Thus, the prosthetic valve may be crimped onto or held by the implant delivery device in a radially compressed state during advancement through the patient's vasculature on the delivery device. The prosthetic valve may be expanded to a 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 devices and may be implanted via a variety of delivery procedures, examples of which will be described in more detail below.

[0032] 1A-2B illustrate an exemplary prosthesis (e.g., a prosthetic heart valve) that can be advanced through a patient's vasculature, e.g., to a native heart valve, by a delivery device, such as the exemplary delivery device illustrated in FIG. 3. The frame of the prosthetic heart valve can include one or more mechanical expansion and locking mechanisms that can be incorporated within the frame, e.g., within axially extending posts of the frame. The mechanical expansion and / or locking mechanisms can be removably coupled to and / or actuated by the delivery device to radially expand and lock the prosthetic heart valve in one or more radially expanded states. As described below, radial expansion of the prosthesis can be monitored in real time.

[0033] Examples of mechanically expandable prosthetic valves 1A-2B show an exemplary prosthetic valve 100, according to one embodiment. Any prosthetic valve disclosed herein is adapted to be implanted in the native aortic valve annulus, but in other embodiments may be adapted to be implanted in other native valve annuluses of the heart (pulmonary, mitral, and tricuspid valves). The disclosed prosthetic valves can also be implanted in blood vessels communicating with the heart, including the pulmonary artery (to replace the function of a diseased pulmonary valve), or the superior or inferior vena cava (to replace the function of a diseased tricuspid valve), or various other veins, arteries, and blood vessels of a patient. The disclosed prosthetic valves can also be implanted in a previously implanted prosthetic valve (which may be a prosthetic surgical valve or a prosthetic transcatheter heart valve) in a valve-in-valve procedure.

[0034] In some embodiments, the disclosed prosthetic valves can be implanted within a docking or anchoring device that is implanted within a native heart valve or blood vessel. For example, in one embodiment, the disclosed prosthetic valves can be implanted within a docking device that is implanted within the pulmonary artery to replace the function of a diseased pulmonary valve, as disclosed in U.S. Patent Application Publication No. 2017 / 0231756, which is incorporated herein by reference. In another embodiment, the disclosed prosthetic valves can be implanted within a docking device that is implanted within or at the native mitral valve, as disclosed in International Publication No. WO2020 / 247907, which is incorporated herein by reference. In another embodiment, the disclosed prosthetic valves can be implanted within a docking device implanted within the superior vena cava or within the inferior vena cava to replace the function of a diseased tricuspid valve, as disclosed in U.S. Patent Application Publication No. 2019 / 0000615, which is incorporated herein by reference.

[0035] 1A-2B illustrate an exemplary embodiment of a prosthesis, such as a prosthetic valve 100 (sometimes referred to herein as a "prosthetic heart valve 100") having a frame 102. FIGS. 2A-2B show the frame 102 alone, while FIGS. 1A-1B show the frame 102 with a valvular structure 150 (which may include leaflets 158, as described further below) within and attached to the annular frame 102. FIG. 1B further shows an optional skirt assembly comprising an outer skirt 103. Although only one side of the frame 102 is shown in FIG. 2B, it should be understood that the frame 102 forms an annular structure with an opposite side substantially identical to the portion shown in FIG. 1B, as shown in FIGS. 1A-2A.

[0036] 1A and 1B, the valvular structure 150 is coupled to and supported within the frame 102. The valvular structure 150 is configured to restrict blood flow through the prosthetic valve 100 from the inflow end portion 134 to the outflow end portion 136. The valvular structure 150 may include a leaflet assembly including, for example, one or more leaflets 158 made of a flexible material. The leaflets 158 may be made in whole or in part from a biological material, from a biocompatible synthetic material, or from other such materials. Suitable biological materials may include, for example, bovine pericardium (or pericardium from other sources). The leaflets 158 may be secured to one another at their adjacent sides to form commissures 152, each of which may be secured to a respective commissure support structure 144 (also referred to herein as a "commissural support") and / or other portions of the frame 102, as described in more detail below.

[0037] 1A and 1B, the valvular structure 150 includes three leaflets 158 that may be configured to fold in a tricuspid arrangement. Each leaflet 158 ​​may have an inflow edge 160 (sometimes referred to as a cusp edge) (FIG. 1A). The inflow edges 160 of the leaflets 158 may define an undulating, curved, scalloped edge that generally circumferentially follows or tracks a portion of the struts 112 of the frame 102 when the frame 102 is in a radially expanded configuration. The inflow edges 160 of the leaflets 158 may be referred to as a "scallop line."

[0038] The prosthetic valve 100 may include one or more skirts attached around the frame 102. For example, as shown in FIG. 1B, the prosthetic valve 100 may include an outer skirt 103 attached around the outer surface of the frame 102. The outer skirt 103 may function as a sealing member for the prosthetic valve 100 by sealing against the tissue of the native annulus and helping to reduce paravalvular leakage through the prosthetic valve 100. In some examples, an inner skirt (not shown) may be attached around the inner surface of the frame 102. The inner skirt may function as a sealing member to prevent or reduce paravalvular leakage, secure the leaflets 158 to the frame 102, and / or protect the leaflets 158 from damage caused by contact with the frame 102 during crimping and during the work cycle of the prosthetic valve 100. In some examples, the inflow edge 160 of the leaflets 158 may be sutured to the inner skirt, generally along the scallop line. The inner skirt may then be sutured to adjacent struts 112 of the frame 102. In other embodiments, as shown in FIG. 1A, the leaflets 158 may be sewn directly to the frame 102 or the reinforcing member 125 (also referred to as a reinforcing skirt or connecting skirt) in the form of a strip of material (e.g., a fabric strip), which is then sewn to the frame 102 along the scallop line via stitches (e.g., whip stitches) 133.

[0039] The inner and outer skirts and the connecting skirt 125 may be formed from any of a variety of suitable biocompatible materials, including any of a variety of synthetic materials, including woven fabrics (e.g., woven polyethylene terephthalate fabrics), or autologous tissue (e.g., pericardial tissue). Further details regarding the use of skirts or sealing members in prosthetic valves can be found, for example, in U.S. Patent Publication No. 2020 / 0352711, which is incorporated herein by reference.

[0040] Further details regarding the assembly of the leaflet assemblies and the assembly of the leaflets and skirts to the frame can be found, for example, in U.S. Provisional Patent Application No. 63 / 209,904, filed June 11, 2021, and No. 63 / 224,534, filed July 22, 2021, which are incorporated by reference herein. Further details of the structure and function of the frame 102 can be found in International Patent Application No. PCT / US2021 / 052745, filed September 30, 2021, which is incorporated by reference herein.

[0041] The frame 102, shown alone and in more detail in Figures 2A and 2B, includes an inflow end 109, an outflow end 108, and a number of axially extending posts 104. The axial direction of the frame 102 is indicated by a longitudinal axis 105 extending from the inflow end 109 to the outflow end 108 (Figures 2A and 2B). Some of the posts 104 may be disposed in axially aligned pairs of first and second struts or posts 122, 124. An actuator 126 (such as a threaded rod or bolt as shown) may extend through one or more pairs of posts 122, 124 to form an integrated expansion and locking mechanism 106 (also referred to as an "actuator mechanism") configured to radially expand and compress the frame 102, as described further below. One or more of the posts 104 may be configured as a support post 107.

[0042] An actuator mechanism 106 (which may be used to radially expand and / or radially compress the prosthetic valve 100) may be incorporated into the frame 102 of the prosthetic valve 100, thereby reducing the crimp profile and / or volume of the prosthetic valve 100. Incorporating the actuator mechanism 106 (which may also be referred to herein as an "expansion and locking mechanism") into the frame 102 may also simplify the design of the prosthetic valve 100, making it less costly and / or easier to manufacture. In the illustrated embodiment, an actuator 126 extends through each pair of axially aligned posts 122, 124. In other embodiments, one or more of the pairs of posts 122, 124 may not have a corresponding actuator.

[0043] The posts 104 may be linked together by a number 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 may include an equal number of support posts 107 and pairs of actuator posts 122, 124, and the pairs of posts 122, 124 and the support posts 107 may 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 (i.e., each strut 112 may be coupled at one end to one of the posts 122, 124 and at the other end to one of the support posts 107). However, the prosthetic valve 100 may include a different number of support posts 107 and pairs of posts 122, 124, and / or the pairs of posts 122, 124 and the support posts 107 may be arranged in a non-alternating order in other embodiments.

[0044] 2B, 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 a third row of struts 115 and a fourth row of struts 116 axially disposed between the first row of struts 113 and the second row of struts 114, respectively. The struts 112 can form and / or define a plurality of cells (i.e., 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 extending circumferentially around the frame 102. Specifically, each first cell 117 may be formed by two columns 113a, 113b of the first row of columns 113, two columns 114a, 114b of the second row of columns 114, and two of the support posts 107. Each second cell 118 may be formed by two columns 115a, 115b of the third row of columns 115, and two columns 116a, 116b of the fourth row of columns 116. As shown in Figures 2A and 2B, each second cell 118 may be disposed within one of the first cells 117 (i.e., the pillars 115a-116b forming the second cell 118 are closer to the center of the axial line of the frame 102 than the pillars 113a-114b and are disposed between the pillars forming the first cell 117 (i.e., the pillars 113a, 113b and the pillars 114a, 114b)).

[0045] As shown in FIGS. 2A and 2B, the struts 112 of the frame 102 may include a curved shape. Each first cell 117 may have an axially extending hexagonal shape including first and second vertices 119 (e.g., inflow vertex 119a and outflow vertex 119b). In embodiments where the delivery device is releasably connected to the outflow vertex 119b (as described below), each inflow vertex 119a may be referred to as a "distal vertex" and each outflow vertex 119b may be referred to as a "proximal vertex". Each second cell 118 may have a diamond shape including first and second vertices 120 (e.g., distal vertex 120a and proximal vertex 120b). In some embodiments, the frame 102 includes 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 other embodiments, the frame 102 may include a greater or lesser number of first cells 117 and a corresponding greater or lesser number of second cells 118 and posts 104.

[0046] As mentioned above, some of the posts 104 may be arranged in pairs of first posts 122 and second posts 124. The posts 122, 124 are aligned with one another along the length of the frame 102 and axially separated from one another by a gap G (FIG. 2B) (those with actuators 126 may be referred to as actuator posts or actuator struts). Each first post 122 (i.e., the lower post shown in FIGS. 2A and 2B) may extend axially from the inflow end 109 of the prosthetic valve 100 toward the second post 124, and each second post 124 (i.e., the upper post shown in FIGS. 2A and 2B) may extend axially from the outflow end 108 of the prosthetic valve 100 toward the first post 122. For example, each first post 122 may be connected to and extend from the inflow apex 119a, and each second post 124 may be connected to and extend from the outflow apex 119b. Each of the first post 122 and second post 124 may include an inner bore configured to receive a portion of an actuator member, such as in the form of a substantially straight threaded rod 126 (or bolt) as shown in the illustrated embodiment. The threaded rod 126 may also be referred to herein as the actuator 126, the actuator member 126, and / or the screw actuator 126. In embodiments in which the delivery device may be releasably connected to the outflow end 108 of the frame 102, the first post 122 may be referred to as the distal post or distal axial post and the second post 124 may be referred to as the proximal post or proximal axial post.

[0047] Each threaded rod 126 extends axially through a corresponding first post 122 and second post 124. Each threaded rod 126 also extends through a bore of a nut 127 captured in a slot or window formed in an end portion 128 of the first post 122. The threaded rod 126 has external threads that engage with internal threads of the bore of the nut 127. The inner bore of the second post 124 (through which the threaded rod 126 extends) may have a smooth and / or unthreaded inner surface to allow the threaded rod 126 to slide freely within the bore. Rotation of the threaded rod 126 relative to the nut 127 produces radial expansion and compression of the frame 102, as described further below.

[0048] In some embodiments, the threaded rod 126 may pass through the nut 127 and extend into the inner bore of the first post 122 toward the inflow end 109 of the frame 102. The nut 127 may be held in a fixed position relative to the first post 122 such that the nut 127 does not rotate relative to the first post 122. In this way, whenever the threaded rod 126 is rotated (e.g., by a physician), the threaded rod 126 can rotate relative to both the nut 127 and the first post 122. The engagement of the outer threads of the threaded rod 126 with the inner threads of the nut 127 prevents the rod 126 from moving axially relative to the nut 127 and first post 122 unless the threaded rod 126 is rotated relative to the nut 127. Thus, the threaded rod 126 may be maintained or held by the nut 127 and may only be moved relative to the nut 127 and / or first post 122 by rotating the threaded rod 126 relative to the nut 127 and / or first post 122. In other examples, instead of using a nut 127, at least a portion of the inner bore of the first post 122 may be threaded. For example, a bore along an end portion 128 of the first post 122 may be provided with internal threads that engage with the external threaded rod 126 such that rotation of the threaded rod causes the threaded rod 126 to move axially relative to the first post 122.

[0049] When the threaded rod 126 extends through and / or is otherwise coupled to a pair of axially aligned posts 122, 124, the pair of axially aligned posts 122, 124 and the threaded rod 126 can function as one of the expansion and locking mechanisms 106. In some embodiments, the threaded rod 126 can extend through each pair of axially aligned posts 122, 124 such that all of the posts 122, 124 (with their corresponding rods 126) function as expansion and locking mechanisms 106. As just one example, the prosthetic valve 100 can include six pairs of posts 122, 124, and each of the six pairs of posts 122, 124 with their corresponding rods 126 can be configured as one of the expansion and locking mechanisms 106 for a total of six expansion and locking mechanisms 106. In other embodiments, not all pairs of posts 122, 124 need to be expansion and locking mechanisms (i.e., actuators). If the pair of posts 122, 124 is not used as an expansion and locking mechanism, the threaded rod 126 does not need to extend through the pair of posts 122, 124.

[0050] The threaded rod 126 can rotate relative to the nut 127, the first post 122, and the second post 124 to axially shorten and / or lengthen the frame 102, thereby radially expanding and / or radially compressing the frame 102 (and thus the prosthetic valve 100), respectively. Specifically, as the threaded rod 126 rotates relative to the nut 127, the first post 122, and the second post 124, the first post 122 and the second post 124 can move axially relative to one another, thereby widening or narrowing the gap G (FIG. 2B) separating the posts 122, 124, thereby radially compressing or radially expanding the prosthetic valve 100, respectively. Thus, the gap G (FIG. 2B) between the first post 122 and the second post 124 narrows as the frame 102 is radially expanded and widens as the frame 102 is radially compressed.

[0051] The threaded rod 126 may extend proximally beyond the proximal end of the second post 124 and may include a head portion 131 at its proximal end that may serve at least two functions. First, the head portion 131 may removably or releasably couple the threaded rod 126 to a respective actuator assembly of a delivery device that may be used to radially expand and / or radially compress the prosthetic valve 100 (e.g., the delivery device 200 of FIG. 3, as described below). Second, the head portion 131 may prevent the second post 124 from moving proximally relative to the threaded rod 126 and may apply a distally directed force to the second post 124, such as when radially expanding the prosthetic valve 100. Specifically, the head portion 131 may have a width that is greater than a diameter of an inner bore of the second post 124 such that the head portion 131 is prevented from moving into the inner bore of the second post 124. Thus, as the threaded rod 126 is threaded further into the nut 127, the head portion 131 of the threaded rod 126 is drawn closer to the nut 127 and the first post 122, thereby drawing the second post 124 toward the first post 122, thereby causing the artificial valve 100 to shorten axially and expand radially.

[0052] The threaded rod 126 may also include a stopper 132 (e.g., in the form of a nut, washer, or flange) disposed thereon. The stopper 132 may be disposed on the threaded rod 126 such that it is located within the gap G. Additionally, the stopper 132 may be integrally formed on the threaded rod 126 or may be fixedly coupled to the threaded rod 126 such that it does not move relative to the threaded rod 126. Thus, the stopper 132 may remain in a fixed axial position on the threaded rod 126 such that it moves in a locking step with the threaded rod 126.

[0053] Rotation of the threaded rod 126 in a first direction (e.g., clockwise) may cause corresponding axial movement of the first post 122 and the second post 124 relative to one another, thereby decreasing the gap G and radially expanding the frame 102, while rotation of the threaded rod 126 in an opposite second direction may cause corresponding axial movement of the first post 122 and the second post 124 away from one another, thereby increasing the gap G and radially compressing the frame. As the threaded rod 126 rotates in the first direction, the head portion 131 of the rod 126 abuts an adjacent surface of the frame (e.g., the outflow apex 119b), and the nut 127 and first post 122 move proximally along the threaded rod 126 toward the second post 124, thereby radially expanding the frame. As the frame 102 moves from the compressed configuration to the expanded configuration, the gap G between the first post 122 and the second post 124 may narrow.

[0054] As the threaded rod 126 rotates in the second direction, the threaded rod 126 and stopper 132 move toward the outflow end 108 of the frame until the stopper 132 abuts the inflow end 170 of the second post 124 (as shown in FIGS. 2A and 2B ). As the rod 126 further rotates in the second direction, the stopper 132 can apply a proximally directed force to the second post 124, radially compressing the frame 102. Specifically, during crimping / radial compression of the prosthetic valve 100, the threaded rod 126 rotates in the second direction (e.g., counterclockwise), causing the stopper 132 to press against (i.e., provide a proximally directed force on) the inflow end 170 of the second post 124, thereby moving the second post 124 away from the first post 122, thereby axially stretching and radially compressing the prosthetic valve 100.

[0055] Thus, each of the second posts 124 can slide axially relative to a corresponding one of the first posts 122, but can be axially held and / or restrained between the head portion 131 and the stopper 132 of the threaded rod 126. That is, each second post 124 can be restrained at its proximal end by the head portion 131 of the threaded rod 126 and at its distal end by the stopper 132. In this manner, the head portion 131 can apply a distally directed force to the second post 124 to radially expand the prosthetic valve 100, while the stopper 132 can apply a proximally directed force to the second post 124 to radially compress the prosthetic valve 100. As described above, radially expanding the prosthetic valve 100 shortens the prosthetic valve 100 axially, causing the inflow end portion 134 and the outflow end portion 136 (Figures 1A and 1B) of the prosthetic valve 100 to move axially toward each other, while radially compressing the prosthetic valve 100 elongates the prosthetic valve 100 axially, causing the inflow end portion 134 and the outflow end portion 136 to move axially away from each other.

[0056] In other embodiments, the threaded rod 126 may be fixed against axial movement relative to the second post 124 (and the stopper 132 may be omitted) such that rotation of the threaded rod 126 in a first direction produces proximal movement of the nut 127 and radial expansion of the frame 102, and rotation of the threaded rod 126 in a second direction produces distal movement of the nut 127 and radial compression of the frame 102.

[0057] As also introduced above, some of the posts 104 may be configured as support posts 107. As shown in Figures 2A and 2B, the support posts 107 may extend axially between the inflow end 109 and outflow end 108 of the frame 102 and each may have an inflow end portion 138 and an outflow end portion 139. The outflow end portion 139 of one or more of the support posts 107 may include a commissure support structure or member 144. The commissure support structure 144 may include a strut portion defining a commissure opening 146 therein.

[0058] The commissure openings 146 (sometimes referred to herein as "commissure windows 146") may extend radially through the thickness of the support post 107 and may be configured to receive a portion of the valvular structure 150 (e.g., the commissures 152) to couple the valvular structure 150 to the frame 102. For example, each commissure 152 may be attached to a respective commissure support structure 144, for example, by inserting a pair of commissure tabs of adjacent leaflets 158 through the commissure openings 146 and suturing the commissure tabs to each other and / or to the commissure support structure 144. In some embodiments, the commissure openings 146 may be completely surrounded by the support post 107 such that a portion of the valvular structure 150 may be slid radially through the commissure openings 146 from the interior to the exterior of the frame 102 during assembly. In the illustrated embodiment, the commissure openings 146 have a substantially rectangular shape that is shaped and sized to receive the commissure tabs of two adjacent leaflets therethrough. However, in other embodiments, the commissure openings can have any of a variety of shapes, such as square, oval, square-oval, triangular, L-shaped, T-shaped, C-shaped, and the like.

[0059] The commissure openings 146 are spaced around the circumference of the frame 102 (or angularly spaced around the frame 102). The spacing may be even or uneven. In one embodiment, the commissure openings 146 are axially offset from the outflow end 108 of the frame 102 by an offset distance d3 (shown in FIG. 2A). By way of example, the offset distance d3 may be in the range of 2 mm to 6 mm. In general, the offset distance d3 should be selected such that when the leaflet is attached to the frame 102 via the commissure openings 146, the free edge (e.g., outflow edge) of the leaflet 158 ​​does not protrude beyond or beyond the outflow end 108 of the frame 102.

[0060] Frame 102 can include any number of support posts 107, any number of which can be configured as commissure support structures 144. For example, frame 102 can include six support posts 107, three of which are configured as commissure support structures 144. However, in other embodiments, frame 102 can include more or less than six support posts 107 and / or more or less than three commissure support structures 144.

[0061] The inlet end portion 138 of each support post 107 may include an extension 154 (illustrated as a cantilevered post in FIGS. 2A and 2B ) that extends toward the inlet end 109 of the frame 102. Each extension 154 may include an aperture 156 that extends radially through a thickness of the extension 154. In some embodiments, the extension 154 may extend such that an inlet edge of the extension 154 aligns or substantially aligns with the inlet end 109 of the frame 102. In use, the extension 154 may prevent or reduce a portion of the outer skirt from extending radially inward, thereby preventing or reducing any blockage of flow through the frame 102 caused by the outer skirt. The extension 154 may further function as a support to which portions of the inner and / or outer skirts and / or leaflets and / or connecting skirts 125 may be coupled. For example, the sutures used to connect the inner and / or outer skirts and / or leaflets and / or connecting skirt 125 may be wrapped around the extension 154 and / or extend through the opening 156.

[0062] As one example, each extension 154 may have an opening 156 (FIG. 2A) or other feature for receiving a suture or other attachment material to connect adjacent inflow edges 160 of leaflets 158 (FIG. 1A), an outer skirt 103 (FIG. 1B), a connecting skirt 125, and / or an inner skirt. In some examples, the inflow edges 160 of each leaflet 158 ​​may be connected to a corresponding extension via a suture 135 (FIG. 1A).

[0063] In some embodiments, the outer skirt 103 may be attached around the outer surface of the frame 102 as shown in FIG. 1B, and the inflow edge of the outer skirt 103 (lower edge in FIG. 1B) may be attached to the inflow edge 160 of the connecting skirt 125 and / or leaflets 158 that are already secured to the frame 102 as well as the frame extensions 154 by sutures 129. The outflow edge of the outer skirt 103 (upper edge in FIG. 1B) may be attached to selected struts by stitches 137. In embodiments where the prosthetic valve includes an inner skirt, the inflow edge of the inner skirt may be secured to the inflow edge 160 prior to securing the cusp edge to the frame such that the inner skirt is between the leaflets and the inner surface of the frame. After the inner skirt and leaflets are secured in place, the outer skirt may be attached around the frame as described above.

[0064] The frame 102 may be a one-piece and / or fastener-less frame that may be constructed from a single piece of material (e.g., Nitinol, stainless steel, or cobalt chrome alloy), such as in the form of a tube. Multiple cells may be formed by removing portions of the single piece of material (e.g., via laser cutting). The threaded rod 126 may be formed separately and then inserted through a bore in the second (proximal) post 124 and threaded into the threaded nut 127.

[0065] In some embodiments, the frame 102 may be formed from a plastically expandable material, such as stainless steel or a cobalt chromium alloy. If the frame is formed from a plastically expandable material, the prosthetic valve 100 may be placed in a radially compressed state along a distal end portion of the delivery device for insertion into the patient's body. When at the desired implantation site, the frame 102 (and thus the prosthetic valve 100) may be radially expanded from the radially compressed state to a radially expanded state via actuation of an actuation assembly of the delivery device (described further below) that rotates the rod 126 to cause expansion of the frame 102. During delivery to the implantation site, the prosthetic valve 100 may be disposed inside a delivery capsule (sheath) to protect the prosthetic valve from contacting the patient's vasculature, such as when the prosthetic valve is advanced through the femoral artery. The capsule may also hold the prosthetic valve in a compressed state having a slightly smaller diameter and crimped profile than would be possible without the capsule, by preventing any recoil (expansion) of the frame when crimped onto the delivery device.

[0066] In other examples, the frame 102 may be formed from a self-expandable material (e.g., Nitinol). When the frame 102 is formed from a self-expandable material, the prosthetic valve may be radially compressed and placed within a capsule of the delivery device to maintain the prosthetic valve in a radially compressed state while being delivered to the implantation site. When at the desired implantation site, the prosthetic valve is deployed or released from the capsule. In some examples, the frame (and thus the prosthetic valve) may partially self-expand from a radially compressed state to a partially radially expanded state. The frame 102 (and thus the prosthetic valve 100) may further radially expand from the partially expanded state to a further radially expanded state via actuation of an actuation assembly of the delivery device (as described further below), which rotates the rods 126 to create an expansion of the frame.

[0067] Examples of Delivery Devices As introduced above, the threaded rod 126 can removably couple the prosthetic valve 100 to an actuator assembly of the delivery device. Referring to FIG. 3 , this shows an exemplary delivery device 200 for delivering a prosthesis or valve 202 (e.g., prosthetic valve 100) to a desired implantation location. The prosthetic valve 202 can be releasably coupled to the delivery device 200. It should be understood that the delivery device 200 and other delivery devices disclosed herein may be used to implant prostheses other than prosthetic valves, such as stents or grafts.

[0068] The delivery device 200 of the illustrated embodiment generally includes a handle 204, a first elongate shaft 206 (which in the illustrated example constitutes an outer shaft) extending distally from the handle 204, at least one actuator assembly 208 extending distally through the first shaft 206, a second elongate shaft 209 (which in the illustrated example constitutes an inner shaft) extending through the first shaft 206, and a nosecone 210 coupled to a distal end portion of the second shaft 209. The second shaft 209 and the nosecone 210 can define a guidewire lumen for advancing the delivery device over a guidewire through the vasculature of a patient. The at least one actuator assembly 208 can be configured to radially expand and / or radially collapse the prosthetic valve 202 when actuated by one or more knobs 211, 212, 214, etc. included on the handle 204 of the delivery device 200.

[0069] While the illustrated embodiment shows two actuator assemblies 208 for illustrative purposes, it should be understood that one actuator 208 may be provided for each actuator (e.g., actuator or threaded rod 126) on the prosthetic valve. For example, three actuator assemblies 208 may be provided for a prosthetic valve having three actuators. In other embodiments, there may be a greater or lesser number of actuator assemblies.

[0070] In some embodiments, the distal end portion 216 of the shaft 206 may be sized to accommodate 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 216 functions (and may also be referred to as) a delivery sheath or capsule for the prosthetic valve during delivery.

[0071] The actuator assemblies 208 may be releasably coupled to the prosthetic valve 202. For example, in the illustrated embodiment, each actuator assembly 208 may be coupled to a respective actuator (such as the threaded rod 126) of the prosthetic valve 202. Each actuator assembly 208 may include a support tube and an actuator member. When actuated, the actuator assembly may transmit a pushing force and / or a pulling force to a portion of the prosthetic valve to radially expand and collapse the prosthetic valve, as described above. The actuator assembly 208 may be at least partially radially disposed within one or more lumens of the first shaft 206 and may extend axially through one or more lumens of the first shaft 206. For example, the actuator assembly 208 may extend through a central lumen of the shaft 206 or through separate respective lumens formed within the shaft 206.

[0072] The handle 204 of the delivery device 200 may include one or more control mechanisms (e.g., knobs or other actuation mechanisms) for controlling different components of the delivery device 200 to expand and / or deploy the prosthetic valve 202. For example, in the illustrated embodiment, the handle 204 includes first, second, and third knobs 211, 212, and 214, respectively.

[0073] The first knob 211 may be a rotatable knob configured to generate axial movement of the first shaft 206 in a distal and / or proximal direction relative to the prosthetic valve 202 to deploy the prosthetic valve from the delivery sheath 216 as the prosthetic valve is advanced to or adjacent a desired implantation location within the patient's body. For example, rotation of the first knob 211 in a first direction (e.g., clockwise) may retract the sheath 216 proximally relative to the prosthetic valve 202, and rotation of the first knob 211 in a second direction (e.g., counterclockwise) may advance the sheath 216 distally. In other embodiments, the first knob 211 may be actuated by sliding or moving the first knob 211 axially, such as by pulling and / or pushing the knob. In other embodiments, actuation of the first knob 211 (rotation or sliding movement of the knob 211) can generate axial movement of the actuator assembly 208 (and thus the prosthetic valve 202) relative to the delivery sheath 216 to advance the prosthetic valve distally from the sheath 216.

[0074] The second knob 212 may be a rotatable knob configured to generate radial expansion and / or compression of the prosthetic valve 202. For example, rotation of the second knob 212 may rotate a threaded rod of the prosthetic valve 202 via the actuator assembly 208. Rotation of the second knob 212 in a first direction (e.g., clockwise) may radially expand the prosthetic valve 202, and rotation of the second knob 212 in a second direction (e.g., counterclockwise) may radially collapse the prosthetic valve 202. In other embodiments, the second knob 212 may be actuated by sliding or moving the second knob 212 axially, such as by pulling and / or pushing the knob.

[0075] The third knob 214 may be a rotatable knob operably connected to a proximal end portion of each actuator assembly 208. The third knob 214 may be configured to retract the outer sleeve or support tube of each actuator assembly 208 to disconnect the actuator assembly 208 from a proximal portion of the actuator of the prosthetic valve (e.g., a threaded rod). Once the actuator assembly 208 is decoupled from the prosthetic valve 202, the delivery device 200 can be removed from the patient, leaving only the prosthetic valve 202 within the patient.

[0076] 4-5, which illustrate how each of the threaded rods 126 of the prosthesis 100 can be removably coupled to an exemplary actuator assembly 300 (e.g., actuator assembly 208) of a delivery device (e.g., delivery device 200). Specifically, FIG. 5 illustrates how one of the threaded rods 126 can be coupled to the actuator assembly 300, and FIG. 4 illustrates how the threaded rod 126 can be removed from the actuator assembly 300.

[0077] As introduced above, the actuator assembly 300 may be coupled to the head portion 131 of each threaded rod 126. The head portion 131 may be included in the proximal end portion 180 of the threaded rod 126 and may extend proximally beyond the proximal end of the second post 124 (FIG. 2A). The head portion 131 may include first and second protrusions 182 defining a channel or slot 184 therebetween and one or more shoulders 186. As mentioned above, the head portion 131 may have a width greater than a diameter of the inner bore of the second post 124 such that the head portion 131 is prevented from moving into the inner bore of the second post 124 and the head portion 131 abuts the outflow end 108 of the frame 102. In particular, the head portion 131 may abut the outflow apex 119b of the frame 102. Head portion 131 can be used to apply a distally directed force to second post 124, for example, during radial expansion of frame 102.

[0078] Each actuator assembly 300 may include a first actuation member configured as a support tube or outer sleeve 302 and a second actuation member configured as a driver 304. The driver 304 may extend through the outer sleeve 302. The outer sleeve 302 is shown transparently in FIGS. 4-5 for illustrative purposes. The distal end portions of the outer sleeve 302 and the driver 304 may be configured to engage or abut the threaded rod 126 (e.g., head portion 131) and / or the proximal end (e.g., apex 119b) of the frame 102. The proximal portions of the outer sleeve 302 and the driver 304 may be operably coupled to a handle (e.g., handle 204) of the delivery device. The delivery device of this embodiment may include the same features described above for the delivery device 200. In certain embodiments, the proximal end portion of each driver 304 may be operably connected to the knob 212 such that rotation (clockwise or counterclockwise) of the knob 212 causes a corresponding rotation of the driver 304. A proximal end portion of each outer sleeve 302 may be operatively connected to a knob 214 such that rotation (clockwise or counterclockwise) of the knob 214 causes corresponding axial movement (proximal or distal) of the sleeve 302 relative to the driver 304. In other embodiments, the handle may include an electric motor for actuating these components.

[0079] The distal end portion of the driver 304 may include a central protrusion 306 configured to extend into the slot 184 of the threaded rod 126 and one or more flexible elongated elements or arms 308 including protrusions or teeth 310 configured to be releasably coupled to the shoulder 186 of the threaded rod 126. The protrusions 310 may extend radially inward toward a longitudinal axis of the second actuation member 304. As shown in FIGS. 4-5 , the elongated elements 308 may be configured to be biased radially outward to an expanded state, for example, by shaping of the elements 308.

[0080] 5, to couple the actuator assembly 300 to the threaded rod 126, the driver 304 may be positioned such that the central projection 306 is disposed within the slot 184 (FIG. 4) and the projection 310 of the elongated element 308 is positioned distal to the shoulder 186. As the outer sleeve 302 is advanced (e.g., distally) over the driver 304, the sleeve 302 compresses the elongated elements 308 so that they abut and / or snap against the shoulder 186, thereby coupling the actuator assembly 300 to the threaded rod 126. Thus, the outer sleeve 302 effectively compresses and locks the projection 310 of the elongated elements 308 and the driver 304 into engagement with (i.e., on) the shoulder 186 of the threaded rod 126, thereby coupling the driver 304 to the threaded rod 126.

[0081] The central projection 306 of the driver 304 extends into the slot 184 of the threaded rod 126 when the driver 304 and the threaded rod 126 are coupled, so that the driver 304 and the threaded rod 126 can be rotationally locked to allow them to rotate together. When so coupled, the driver 304 can be rotated (e.g., using the knob 212 of the handle of the delivery device 200) to radially expand or radially compress the prosthesis with a corresponding rotation of the threaded rod 126. The central projection 306 can be configured (e.g., sized and shaped) to be advantageously spaced from the inner wall of the outer sleeve 302 such that the central projection 306 does not come into frictional contact with the outer sleeve 302 during rotation. In the illustrated embodiment, the central projection 306 has a substantially rectangular shape in cross section, but in other embodiments the projection 306 can have any of a variety of shapes, e.g., square, triangular, oval, etc. The slot 184 can be correspondingly shaped to receive the projection 306.

[0082] The outer sleeve 302 can be advanced distally relative to the driver 304 through the elongated element 308 until the outer sleeve 302 engages the frame 102 (e.g., the second post 124 of the frame 102). The distal end portion of the outer sleeve 302 can also include first and second support extensions 312 defining a gap or notch 314 between the extensions 312. The support extensions 312 can be oriented such that when the actuator assembly 300 is coupled to a respective threaded rod 126, the support extensions 312 extend partially over an adjacent end portion (e.g., an upper end portion) of one of the second posts 124 on opposing sides of the post 124. In this manner, engagement of the support extensions 312 with the frame 102 can counter rotational forces exerted on the frame 102 by the rod 126 during expansion of the frame 102. Without a counter force acting against these rotational forces, the frame could tend to "shock" or rock in the direction of the rod rotation when actuated to expand the frame. The illustrated configuration is advantageous in that the outer sleeve, when engaged with the proximal post 124 of the frame 102, can prevent or reduce such shoving or rocking motion of the frame 102 as it is radially expanded.

[0083] To separate the actuator assembly 300 from the prosthesis 100, the sleeve 302 may be withdrawn proximally relative to the driver 304 until the sleeve 302 no longer covers the elongated element 308 of the driver 304. As described above, the sleeve 302 may be used to hold the elongated element 308 against the shoulder 186 of the threaded rod 126 because the elongated element 308 may be naturally biased to a radially outward position in which the elongated element 308 does not engage the shoulder 186 of the threaded rod 126. Thus, once the sleeve 302 is withdrawn such that it no longer covers / constrains the elongated element 308, the elongated element 308 naturally and / or passively deflects and thereby releases from the shoulder 186 of the threaded rod 126, thereby allowing the driver 304 to be separated from the threaded rod 126.

[0084] The sleeve 302 can be advanced (moved distally) and / or retracted (moved proximally) relative to the driver 304 via a control mechanism (e.g., knob 214) on the handle 204 of the delivery device 200, by an electric motor, and / or by another suitable actuation mechanism. For example, a physician can rotate the knob 214 in a first direction to apply a distally directed force to the sleeve 302 and rotate the knob 214 in an opposite second direction to apply a proximally directed force to the sleeve 302. Thus, when the sleeve 302 does not abut the prosthesis and the physician rotates the knob 214 in a first direction, the sleeve 302 can move distally relative to the driver 304, thereby advancing the sleeve 302 over the driver 304. When the sleeve 302 abuts the prosthesis, the physician can rotate the knob 214 in a first direction to push the entire prosthesis distally through the sleeve 302. Additionally, when the physician rotates the knob 214 in a second direction, the sleeve 302 may move proximally relative to the driver 304 , thereby withdrawing / retracting the sleeve 302 from the driver 304 .

[0085] Exemplary Delivery Techniques To implant the prosthetic valve into the native aortic valve via a transfemoral delivery approach, the prosthetic valve is mounted in a radially compressed state along a distal end portion of a delivery device. The prosthetic valve and the distal end portion of the delivery device are inserted into the femoral artery and advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta. The prosthetic valve is positioned inside the native aortic valve and radially expanded (e.g., by inflating a balloon, by actuating one or more actuators of the delivery device, or by deploying the prosthetic valve from a sheath and allowing the prosthetic valve to self-expand). Alternatively, the prosthetic valve can be implanted inside the native aortic valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery device) 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 inside the native aortic valve. Alternatively, in a transaortic procedure, the prosthetic valve (on the distal end portion of the delivery device) is introduced into the aorta through a surgical incision in the ascending aorta, such as by a partial J sternotomy or a right parasternal minithoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

[0086] To implant the prosthetic valve inside 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 device. The prosthetic valve and the distal end portion of the delivery device are inserted into the femoral vein and advanced into the inferior vena cava and through the inferior aorta, 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, the prosthetic valve may be implanted inside the native mitral valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery device) 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 inside the native mitral valve.

[0087] To implant the prosthetic valve inside the native tricuspid valve, the prosthetic valve is mounted in a radially compressed state along the distal end portion of the delivery device. The prosthetic valve and the distal end portion of the delivery device are inserted into the femoral vein and advanced into and through the inferior vena cava into the right atrium, where the prosthetic valve is positioned inside the native tricuspid valve. A similar approach may be used to implant the prosthetic valve inside the native pulmonary valve or pulmonary artery, except the prosthetic valve is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve / artery.

[0088] Another delivery approach is a transatrial approach, whereby the prosthetic valve (on the distal end portion of the delivery device) is inserted through an incision in the chest and an incision is made through the atrial wall (of the right or left atrium) to access either of the native heart valves. Atrial delivery can also be performed intravascularly, such as from a pulmonary vein. Yet another delivery approach is a transventricular approach, whereby the prosthetic valve (on the distal end portion of the delivery device) is inserted through an incision in the chest and an incision is made through the wall of the right ventricle (typically at or near the base of the heart) to implant the prosthetic valve inside the native tricuspid valve or inside the native pulmonary valve or inside the pulmonary artery.

[0089] In all delivery approaches, the delivery device can be advanced over a guidewire previously inserted into the patient's vasculature. Moreover, the disclosed delivery approaches are not intended to be limiting. Any of the prosthetic valves disclosed herein can be implanted using any of a variety of delivery procedures and any of a variety of delivery devices known in the art.

[0090] The treatment techniques, methods, processes, etc. described or suggested in this specification or the references incorporated herein may be performed on living animals or on non-living simulations such as cadavers, cadaver hearts, anthropomorphic ghosts, simulators (e.g., simulated using body parts, tissues, etc.).

[0091] Another embodiment of a frame for a prosthesis Figure 6 shows a perspective view of a portion of frame 402 according to another embodiment. A flattened portion of frame 402 is shown in Figure 7. Like frame 102, frame 402 may be included in a prosthesis, such as prosthetic valve 100. In certain embodiments, the prosthetic heart valve may include frame 402, leaflet structure 150 (including multiple leaflets 158), and outer skirt 103. Leaflets 158 and outer skirt 103 may be attached to frame 402 in the same manner as described above for prosthetic valve 100.

[0092] The frame 402 may have a similar structure to the frame 102. For example, the frame 402 may have an inflow end 409, an outflow end 408, and a number of axially extending posts 404. A portion of the posts 404 may be arranged as pairs of axially aligned first and second actuator posts 422, 424.

[0093] In any of the embodiments described herein, the first actuator posts 422 may have the same length and the second actuator posts 424 may also have the same length. The axial length of the first actuator posts 422 may be the same as or different from the axial length of the second actuator posts 424.

[0094] A screw actuator or rod 426 (similar to threaded rod 126) can extend through one or more pairs of actuator posts 422, 424 to form an integrated expansion and locking mechanism or actuator mechanism 406 configured to radially expand and compress the frame 402 based on the same mechanisms described above (e.g., rotation of rod 426).

[0095] For example, the first actuator post 422 can receive a nut 427 that is held in a fixed position relative to the first actuator post 422 such that the nut 427 does not rotate relative to the first actuator post 422. A threaded portion of the rod 426 can extend through and engage with the internal threads of the nut 427 such that rotation of the rod 426 can move the rod 426 axially relative to both the nut 427 and the first actuator post 422. For example, the rod 426 can be configured to rotate in a first direction (e.g., clockwise or counterclockwise) to thread further into the threaded bore to axially compress and radially expand the frame 402, and the rod 426 can be configured to rotate in an opposite second direction (e.g., counterclockwise or clockwise) to axially elongate and radially compress the frame 402. Instead of or in addition to being threaded, the first actuator post 422 may have a threaded bore that engages with a threaded portion of the rod 426 .

[0096] In some embodiments, a rod 426 may extend through each pair of axially aligned actuator posts 422, 424 such that all of the actuator posts 422, 424 (with their corresponding rods 426) function as extension and locking mechanisms 406. For example, the frame 402 may have six pairs of actuator posts 422, 424, and each of the six pairs of actuator posts 422, 424 with their corresponding rods 426 may be configured as one of the extension and locking mechanisms 406 for a total of six extension and locking mechanisms 406. In other embodiments, not all pairs of actuator posts 422, 424 need to be extension and locking mechanisms (i.e., actuators).

[0097] As shown, each first actuator post 422 may have a first end 419a and a second end 420a, with the second end 420a being closer to the corresponding (paired) actuator post 424 than the first end 419a. Each second actuator post 424 may have a first end 420b and a second end 419b, with the first end 420b being closer to the corresponding (paired) actuator post 422 than the second end 419b. Thus, when the one or more rods 426 rotate to radially expand or compress the frame 402, each pair of actuator posts 422, 424 may move axially relative to one another. In this manner, the axial distance L1 between the first end 419a of the actuator post 422 and the second end 419b of the paired actuator post 424 may change accordingly. For example, the distance L1 increases when the frame 402 is radially compressed and decreases when the frame 402 is radially expanded.

[0098] In certain embodiments, the rod 426 includes a stopper (e.g., stopper 132, not shown in FIG. 6 ) positioned adjacent the first end 420 b of the actuator post 424, as described above for the frame 102, and a head portion 431 positioned adjacent the second end 419 b of the actuator post 424, and can apply proximally and distally directed forces to the post 424 during radial compression and expansion of the frame, respectively.

[0099] Similarly, some of the posts 404 may be configured as support posts 407 that extend axially (e.g., parallel to the pairs of actuator posts 422, 424) around the circumference of the frame 402. The posts 404 may be connected together by a number of circumferentially extending struts 412. Each strut 412 extends circumferentially between adjacent posts 404 to connect all of the axially extending posts 404. As an example, the frame 402 may include an equal number of support posts 407 and pairs of actuator posts 422, 424, where the pairs of actuator posts 422, 424 and the support posts 407 may be arranged in an alternating order such that each strut 412 is disposed between one of the pairs of actuator posts 422, 424 and one of the support posts 407 (i.e., each strut 412 may have one end coupled to one of the actuator posts 422, 424 and the other end coupled to one of the support posts 407). However, the frame 402 may include a different number of support posts 407 and pairs of actuator posts 422, 424, and / or the pairs of actuator posts 422, 424 and support posts 407 may be arranged in a non-alternating order in other embodiments. Similarly, the struts 412 may form and / or define a plurality of first cells 417 (which may be referred to in some embodiments as outer cells) and a plurality of second cells 418 (which may be referred to in some embodiments as inner cells) of the frame 402, such that each second cell 418 may be disposed within one of the first cells 417. Each pair of first cells 417 and second cells 418 may be referred to as a "row of cells" that spans the height of the frame from the inflow end 409 to the outflow end 410 in the illustrated embodiment.

[0100] Each of the support posts 407 may have a first end 438 and a second end 439, the second end 439 being closer to the outflow end 408 than the first end 438. In the illustrated embodiment, each of the support posts 407 may have an extension 458 that may extend such that the first end 438 may be aligned or substantially aligned with the inflow end 409 of the frame 402. In certain embodiments, at least a portion of the extension 458 may have a respective opening 456 that extends through a thickness of the extension 458. In other embodiments, at least a portion of the support posts 407 may not have an extension 458, for example, the first end 438 may terminate at a junction 411 between two adjacent struts 412 and thus be axially offset from the inflow end 409. In the illustrated embodiment, each of the support posts 407 has a fixed axial length L2 (as opposed to variable L1) measured between the first end 438 and the second end 439.

[0101] The delivery device 200 described above can be used to deliver and deploy a prosthesis comprising a frame 402. For example, one or more actuator assemblies 208 can be releasably coupled to respective actuators or rods 426 of the frame 402, and one or more control mechanisms (e.g., 211, 212, 214, etc.) on the handle 204 can control different components of the delivery device 200 to expand and / or deploy a prosthesis including the frame 402, as described above.

[0102] As described further below, the frame 402 may include one or more markers configured to allow an operator (e.g., a physician) to monitor the radial expansion process of the frame 402 (and the prosthetic device comprising the frame) in real time during operation.

[0103] Exemplary Techniques for Monitoring Uniformity of Radial Expansion of Frame According to certain embodiments, the frame 402 can include two or more pairs of first and second movable markers 440, 442, where the pairs of movable markers are circumferentially spaced apart from one another. The first and second movable markers 440, 442 of each pair are axially aligned and axially movable relative to one another as the frame 402 expands radially.

[0104] For example, each first movable marker 440 may be located on a respective first actuator post 422, and each second movable marker 442 may be located on a respective second actuator post 424. Thus, when the pair of actuator posts 422, 424 move axially relative to one another, the first and second movable markers 440, 442 located on the pair of actuator posts 422, 424 also move axially relative to one another.

[0105] In some embodiments, each pair of actuator posts 422, 424 may include a corresponding pair of first and second movable markers 440, 442. In other embodiments, the first and second movable markers 440, 442 are located on some pairs of actuator posts 422, 424 but not on other pairs of actuator posts 422, 424. For example, if the frame 402 has six pairs of actuator posts 422, 424, the first and second movable markers 440, 442 may be located on any selected two, three, four, or five pairs of actuator posts 422, 424, or on all six pairs.

[0106] As described herein, the positions of the first and second movable markers 440, 442 can be configured such that the difference in axial distance between each pair of the first movable marker 440 and the second movable marker 442 can indicate the evenness of radial expansion of the frame.

[0107] For example, FIG. 7 shows two first movable markers 440a, 440b and two corresponding second movable markers 442a, 442b located on two adjacent pairs of first and second actuator posts 422, 424, respectively.

[0108] In the illustrated embodiment, first movable markers 440a, 440b are located adjacent to the first ends 419a of the respective first actuator posts 422. Second movable markers 442a, 442b are located adjacent to the second ends 419b of the respective second actuator posts 424. The distance between each of the first movable markers 440a, 440b and their respective first ends 419a may be the same, and the distance between each of the second movable markers 442a, 442b and their respective second ends 419b may also be the same.

[0109] As the frame 402 radially expands, both the axial distance between the first and second movable markers 440a, 442a (designated as A1) and the axial distance between the first and second movable markers 440b, 442b (designated as A2) decrease as the pair of first and second actuator posts 422, 424 move toward one another. Conversely, as the frame 402 radially compresses, both A1 and A2 increase as the pair of first and second actuator posts 422, 424 move away from one another.

[0110] Thus, the difference between the axial differences A1 and A2 along the different cell rows may indicate the uniformity of the radial expansion of the frame. Specifically, a decrease in the difference between A1 and A2 may indicate an increase in the uniformity of the expansion (e.g., both cell rows are expanding at the same or substantially the same rate), while an increase in the difference between A1 and A2 may indicate a decrease in the uniformity of the expansion (e.g., the cell rows are expanding at different rates). For example, if A1 is the same or substantially the same as A2, it may indicate that the frame 402 is uniformly expanded. In contrast, if the difference between A1 and A2 exceeds a predetermined threshold, it may indicate that the frame 402 is non-uniformly expanded and may be considered undesirable. More specifically, if the difference between A1 and A2 exceeds a predetermined threshold, this may indicate that the expansion of the frame along the first cell row corresponding to A1 (the pair of cells 417, 418) has exceeded the expansion of the frame along the second cell row corresponding to A2 (or vice versa) beyond what is acceptable to achieve full and thorough deployment of the frame.

[0111] As mentioned above, in some embodiments, a pair of movable markers 440, 442 may be provided on each pair of actuator posts 422, 424. Thus, each row of cells may be provided with a pair of movable markers 440, 422 such that the rate and extent of expansion of each row of cells can be compared to one another to determine whether the frame is deploying in a uniform manner.

[0112] Uneven radial expansion of the frame 402 may occur for a number of reasons. For example, calcification of the native valve may constrain radial expansion of the frame 402 (and the corresponding prosthetic valve) at locations around the frame that contact calcified nodes formed on the native valve. In other words, if a portion of the frame contacts a calcified node, that portion of the frame may not fully expand, while the remainder of the frame may fully expand. In response to detecting uneven radial expansion of the frame, corrective measures may be performed.

[0113] For example, the unevenly expanded frame 402 may be radially compressed (e.g., by manipulating the knob 212 of the delivery device 200). In certain cases, the frame 402 need only be partially compressed, so long as the frame 402 is disengaged from the calcified tissue. The frame 402 may then be repositioned axially and / or rotationally (e.g., by manipulating the knob 211 and / or other components of the delivery device 200) such that the frame 402 is spaced and / or oriented in a different direction relative to the calcified native tissue. The frame 402 may then be re-expanded (e.g., by manipulating the knob 212 of the delivery device 200) and the evenness of the radial expansion of the frame may be continuously monitored, and such monitoring may be performed in real time as the frame 402 is radially expanded.

[0114] As described herein, each of the first and second movable markers 440, 442 can be configured to be viewable under fluoroscopy.

[0115] According to one embodiment, each first movable marker 440 may be in the form of an aperture 444 that extends through the thickness of the respective first actuator post 422, and each second movable marker 442 may include another aperture 446 that extends through the thickness of the respective second actuator post 424. In the illustrated embodiment, both apertures 444 and 446 extend radially through the thickness of the respective first and second actuator posts 422, 424. In other embodiments, one or both of the apertures 444, 446 may extend in different directions, for example, may extend circumferentially through the thickness of the respective first and second actuator posts 422, 424.

[0116] According to another embodiment, each first movable marker 440 can include a radiopaque material having a different radiopacity than that of the respective first actuator post 422, and each second movable marker 442 can include a radiopaque material having a different radiopacity than that of the respective second actuator post 424. In certain embodiments, the first and second movable markers 440, 442 can include the same radiopaque material. In other embodiments, the first and second movable markers 440, 442 can include different radiopaque materials. In certain embodiments, the radiopaque material for the movable markers can be selected from any known or later discovered radiopaque material, such as iridium, tantalum, platinum, platinum-iridium alloy, barium sulfate, bismuth subcarbonate, bismuth oxychloride, and the like.

[0117] The radiopaque markers 440, 442 may have any of a variety of shapes, such as a disk shape, a square, a rectangle, an oval, a triangle, etc. The radiopaque markers 440, 442 may be attached directly onto the posts 422, 424, respectively, via a variety of techniques or mechanisms, such as, for example, by welding the marker to the post, adhesives, mechanical fasteners, etc. In some embodiments, the markers 440, 442 may be placed into correspondingly shaped openings formed in the posts 422, 424 and secured in place via a friction or press fit, welding, adhesives, and / or mechanical fasteners.

[0118] According to yet another embodiment, each first movable marker 440 can include a protrusion extending (e.g., radially inward, radially outward, circumferentially, or laterally, etc.) from a respective first actuator post 422, and each second movable marker 442 can include another protrusion extending (e.g., radially inward, radially outward, circumferentially, or laterally, etc.) from a respective second actuator post 424. The protrusions on the first and second actuator posts 422, 424 can extend in the same direction or different directions. Additionally, the protrusions on the first and second actuator posts 422, 424 can have the same or different sizes and / or shapes. The protrusions can enhance visibility of the markers under fluoroscopy.

[0119] In certain embodiments, the first and second movable markers 440, 442 may be mixed in type. For example, some of the first movable markers 440 (or the second movable markers 442) may be configured as apertures while other first movable markers 440 (or the second movable markers 442) may be configured as protrusions and / or markers attached to posts. In another embodiment, the first movable markers 440 may be configured as protrusions and the second movable markers 442 may be configured as apertures. In yet another embodiment, at least some of the first and / or second movable markers 440, 442 may be configured as protrusions that include a radiopaque material having a radiopacity different from the radiopacity of the respective first and / or second actuator posts 422, 424.

[0120] In certain embodiments, two or more pairs of first movable markers 440 and second movable markers 442 may be uniformly distributed around the circumference of the frame 402. For example, if the frame 402 has six pairs of actuator posts 422, 424 uniformly distributed around the circumference of the frame, the first and second movable markers 440, 442 may be disposed on all six pairs of actuator posts 422, 424, or on three pairs of actuator posts 422, 424 that are equidistant and 120 degrees from each other, or on two pairs of diametrically opposed actuator posts 422, 424.

[0121] Alternatively, two or more pairs of first movable markers 440 and second movable markers 442 may be distributed non-uniformly around the circumference of the frame 402. For example, if the frame 402 has six pairs of actuator posts 422, 424 evenly distributed around the circumference of the frame, the first and second movable markers 440, 442 may be located on only two circumferentially adjacent pairs of actuator posts 422, 424.

[0122] Exemplary Techniques for Monitoring Frame Size During Radial Expansion According to certain embodiments, the frame 402 can include at least a pair of first and second fixed markers 450, 452 that are axially spaced from one another by a fixed distance.

[0123] For example, as shown in FIGS. 6-7, a pair of first and second fixed markers 450, 452 may be located on a selected support post 407. The first fixed marker 450 may be located on the support post 407 adjacent the first end 438 (or adjacent the joint 411), and the second fixed marker 452 may be located on the support post 407 adjacent the second end 439. The axial distance between the first fixed marker 450 and the second fixed marker 452 (denoted as A0) may be a predetermined constant value. In certain embodiments, A0 is slightly less than or approximately equal to the axial length (L2) of the support post 407. For example, the A0 / L2 ratio may be between 50% and 100%, inclusive.

[0124] In certain embodiments, each support post 407 may have a corresponding pair of first and second fixed markers 450, 452. In other embodiments, only selected support posts 407 have the first and second fixed markers 450, 452. For example, if the frame 402 has six support posts 407, the first and second fixed markers 450, 452 may be located on any selected one, two, three, four, or five, or all six support posts 407. If the frame 402 has multiple pairs of first and second fixed markers 450, 452, each pair of first and second fixed markers 450, 452 may have the same predetermined axial distance A0 between them.

[0125] As described herein, each of the first and second fixed markers 450, 452 can be configured to be viewable under fluoroscopy.

[0126] According to one embodiment, the first and second fixed markers 450, 452 may include respective apertures 456 that extend through the thickness of the corresponding support post 407. In the illustrated embodiment, both apertures 456 extend radially through the thickness of the support post 407. In other embodiments, one or both apertures 456 may extend in a different direction, for example, may extend circumferentially through the thickness of the support post 407.

[0127] According to another embodiment, the first and second fixation markers 450, 452 may comprise a radiopaque material having a radiopacity different from the radiopacity of the corresponding support post 407. In certain embodiments, the first and second fixation markers 450, 452 may comprise the same radiopaque material. In other embodiments, the first and second fixation markers 450, 452 may comprise different radiopaque materials. In certain embodiments, the radiopaque material of the fixation markers may be selected from any known or later discovered radiopaque material, such as iridium, tantalum, platinum, platinum-iridium alloy, barium sulfate, bismuth subcarbonate, bismuth oxychloride, and the like.

[0128] The radiopaque markers 450, 452 may have any of a variety of shapes, such as a disk shape, a square, a rectangle, an oval, a triangle, etc. The radiopaque markers 450, 452 may be attached directly onto the post 407 via a variety of techniques or mechanisms, such as, for example, by welding the marker to the post, adhesives, mechanical fasteners, etc. In some embodiments, the markers 450, 452 may be placed into correspondingly shaped openings formed in the post 407 and secured in place via a friction or press fit, welding, adhesives, and / or mechanical fasteners.

[0129] According to yet another embodiment, the first and second fixed markers 450, 452 may include respective protrusions extending (e.g., radially inward, radially outward, circumferentially, laterally, etc.) from the corresponding support post 407. The protrusions on the support post 407 may extend in the same direction or in different directions. Additionally, the protrusions on the support post 407 may have the same or different sizes and / or shapes.

[0130] In certain embodiments, the types of first and second fixation markers 452, 454 can be mixed. For example, some of the fixation markers 452 and / or 454 can be configured as apertures, while other fixation markers 452 and / or 454 can be configured as protrusions and / or markers attached to the posts 407. In another embodiment, at least some of the fixation markers 452 and / or 454 can be configured as protrusions that include a radiopaque material having a different radiopacity than that of the corresponding support post 407.

[0131] In certain embodiments, the pairs of first and second fixed markers 450, 452 may be uniformly distributed around the circumference of the frame 402. For example, if the frame 402 has six support posts 407 uniformly distributed around the circumference of the frame, the pairs of first and second fixed markers 450, 452 may be located on all six support posts 407, or on three equidistant support posts 407 that are 120 degrees from each other, or on two diametrically opposed support posts 407. Alternatively, the pairs of first and second fixed markers 450, 452 may be non-uniformly distributed around the circumference of the frame 402.

[0132] According to certain embodiments, the predetermined axial distance A0 can serve as a reference or calibration value based on which the axial length and / or radial diameter of the frame 402 can be estimated, and thus the size of the frame 402 during radial expansion and / or compression can be monitored in real time.

[0133] For example, the axial distance between a selected pair of first and second movable markers (e.g., A1, A2, etc.) may be compared to a fixed axial distance A0. Such a comparison may be performed by an operator (e.g., a physician), e.g., visually under fluoroscopy. Based on such a comparison, the axial distance between the selected pair of first and second movable markers may be determined or estimated based on A0. In certain embodiments, one or more calibration curves (or tables) may be provided that characterize the relationship between the axial distance between the selected pair of first and second movable markers and the axial length and / or radial diameter of the frame 402. Thus, the axial length and / or radial diameter of the frame 402 may also be determined or estimated by comparing the axial distance between the selected pair of first and second movable markers to a fixed axial distance A0.

[0134] Additionally, each pair of movable markers 440, 442 can be compared to a pair of fixed markers 450, 452 to determine whether the frame is expanding in an acceptable manner with the required degree of uniform expansion. For example, if the relative distance between A1 and A0 is greater or less than the relative distance between A2 and A0, this may indicate that the cell rows or frame portions corresponding to A1 and A2 are expanding non-uniformly. If the difference in frame expansion between the two cell rows or frame portions exceeds a predetermined value or is otherwise unacceptable, the user may take corrective action by at least partially radially compressing the prosthesis, repositioning the prosthesis, and then re-expanding the prosthesis.

[0135] sterile Any of the systems, devices, apparatus, etc. herein may be sterilized (e.g., using heat / thermal, pressure, steam, radiation, and / or chemicals, etc.) to ensure that they are safe for use on patients, and any of the methods herein may include sterilizing the associated system, device, apparatus, etc. as one of the method steps. Examples of heat / thermal sterilization include steam sterilization and autoclave sterilization. Examples of radiation for use in sterilization include, but are not limited to, gamma radiation, ultraviolet radiation, and electron beam. Examples of chemicals for use in sterilization include, but are not limited to, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization using hydrogen peroxide may be accomplished, for example, using hydrogen peroxide plasma.

[0136] Additional Examples of the Disclosed Technique In view of the above implementations of the disclosed subject matter, the present application discloses additional embodiments, as listed below. It should be noted that any one feature of an embodiment in isolation, or two or more features of that embodiment taken in combination, and optionally in combination with one or more features of one or more additional embodiments, are also further embodiments that fall within the disclosure of the present application.

[0137] Example 1. A prosthetic device comprising: a radially compressible and expandable frame; and a screw actuator coupled to the frame and configured to rotate to radially expand the frame from a radially compressed state to a radially expanded state, the frame comprising two or more pairs of first and second movable markers, the first and second movable markers of a pair being circumferentially spaced from one another, the first and second movable markers of each pair being axially aligned and axially movable relative to one another such that an axial distance between the first and second movable markers of each pair can change as the frame is radially expanded, and positions of the first and second movable markers are configured such that a difference between the axial distance of one of the pairs of first and second movable markers and the axial distance of the other of the pairs of first and second movable markers can indicate an evenness of radial expansion of the frame.

[0138] Example 2. A prosthetic device as described in any of the examples herein, particularly example 1, wherein the frame includes a plurality of pairs of first and second posts, the pairs of first and second posts being circumferentially spaced from one another, the first and second posts of each pair being axially movable relative to one another, the screw actuator extends through the first and second posts of selected pairs of posts, the first post of two or more pairs of posts includes the first movable marker, and the second post of the two or more pairs of posts includes the second movable marker.

[0139] Example 3. A prosthetic device as described in any of the examples herein, particularly example 2, wherein each first movable marker includes a first opening extending radially through the thickness of each of the first posts, and each second movable marker includes a second opening extending through the thickness of each of the second posts.

[0140] Example 4. A prosthetic device as described in any of the examples herein, particularly any one of Examples 2-3, wherein the first and second movable markers comprise a radiopaque material having a radiopacity different from the radiopacity of the first and second posts.

[0141] Example 5. The prosthetic device described in any of the examples herein, particularly any one of Examples 1-4, wherein the two or more pairs of first and second movable markers are evenly distributed around the circumference of the frame.

[0142] Example 6. The prosthetic device of any of the examples herein, particularly any one of Examples 1-5, wherein the frame comprises six pairs of first and second movable markers.

[0143] Example 7. The prosthetic device described in any of the examples herein, particularly any one of Examples 1-6, further comprising at least one pair of first and second fixed markers axially spaced apart from each other by a fixed distance such that the distance between a selected pair of the first movable marker and the second movable marker can be compared to a fixed distance between the at least one pair of the first fixed marker and the second fixed marker.

[0144] Example 8. A prosthetic device as described in any of the examples herein, particularly example 7, wherein at least one pair of the first and second fixation markers is located on a third post of the frame that extends parallel to multiple pairs of first and second posts.

[0145] Example 9. The prosthetic device of any of the examples herein, particularly example 8, wherein each of the first and second fixation markers includes an aperture extending through the thickness of the third post.

[0146] Example 10. A prosthetic device as described in any of the examples herein, particularly any one of Examples 8-9, wherein the first and second fixation markers comprise a radiopaque material having a different radiopacity than that of the third post.

[0147] Example 11. A prosthesis comprising a radially compressible and expandable frame and a screw actuator coupled to the frame and configured to rotate to radially expand the frame from a radially compressed state to a radially expanded state, the frame comprising a pair of first and second fixed markers axially spaced a fixed distance from each other and a pair of first and second movable markers axially movable relative to each other as the frame radially expands, wherein the distance between the pair of first and second fixed markers can be compared to the fixed distance between the pair of first and second fixed markers.

[0148] Example 12. The prosthetic device of any of the examples herein, particularly example 11, wherein the pair of first and second fixation markers are located on axially extending support posts of the frame.

[0149] Example 13. The prosthetic device of any of the examples herein, particularly example 12, wherein each of the first and second fixation markers comprises an aperture extending through a thickness of the support post.

[0150] Example 14. A prosthetic device described in any of the examples herein, particularly any one of Examples 12-13, wherein the first and second fixation markers comprise a radiopaque material having a different radiopacity than that of the support post.

[0151] Example 15. A prosthetic device described in any of the examples herein, particularly any one of Examples 12-14, wherein the support post is one of a plurality of support posts, each of the plurality of support posts including a respective pair of first and second fixation markers having a fixed distance therebetween.

[0152] Example 16. A prosthetic device as described in any of the examples herein, particularly any one of Examples 11 to 15, wherein the frame includes a plurality of pairs of the first and second posts, the first and second posts of each pair being axially movable relative to one another, the screw actuator extends through an inner bore of the second post and is coupled to the first post of a selected pair of posts, the first post of the selected pair includes the first movable marker, and the second post of the selected pair includes the second movable marker.

[0153] Example 17. A prosthetic device as described in any of the examples herein, particularly example 16, wherein the first movable marker has a first opening extending through a first post of a selected pair and the second movable marker has a second opening extending through the second post of a selected pair.

[0154] Example 18. A prosthetic device described in any of the examples herein, particularly any one of Examples 16-17, wherein the first and second movable markers comprise a radiopaque material having a radiopacity different from the radiopacity of the first and second posts.

[0155] Example 19. A prosthetic device as described in any of the embodiments herein, particularly any one of embodiments 16-18, wherein the screw actuator is one of a plurality of screw actuators, each screw actuator extending through a respective pair of first and second posts, and the plurality of screw actuators are configured to rotate in a first direction to radially expand the frame and to rotate in an opposite second direction to radially compress the frame.

[0156] Example 20. A prosthetic device as described in any of the embodiments herein, particularly any one of embodiments 16-19, wherein the frame further comprises a plurality of axially extending third posts, each third post being disposed between two pairs of first and second posts, each pair of first and second posts being disposed between two of the third posts, and a plurality of struts extending between and connecting the pairs of first and second posts and the plurality of third posts define a plurality of cells extending circumferentially around the frame.

[0157] Example 21. A frame comprising a plurality of pairs of axially extending first and second actuator posts, each pair of the first and second actuator posts being axially movable relative to one another, at least one rod extending through an inner bore of a selected second actuator post and coupled to a selected first actuator post paired with the selected second actuator post, wherein rotation of the rod is configured to radially expand the frame from a radially compressed state to a radially expanded state, and two or more pairs of first and second movable markers. 1. A prosthetic device comprising: a frame, the first movable markers located on two or more first actuator posts and the second movable markers located on two or more second actuator posts that pair with the two or more first actuator posts, the first and second movable markers of each pair being spaced from each other by an axial distance that decreases as the frame is radially expanded, and positions of the first and second movable markers are configured such that a difference between the axial distance of one of the pair of first and second movable markers and the axial distance of the other of the pair of first and second movable markers as the frame is radially expanded can indicate an evenness of radial expansion of the frame.

[0158] Example 22. The prosthetic device of any of the examples herein, particularly example 21, wherein the first and second movable markers comprise apertures extending through the first and second actuator posts.

[0159] Example 23. A prosthetic device as described in any of the examples herein, particularly example 21, wherein the first and second movable markers comprise a radiopaque material having a radiopacity different from the radiopacity of the first and second actuator posts.

[0160] Example 24. A prosthetic device as described in any of the examples herein, particularly any one of Examples 21 to 23, wherein the frame further comprises at least one axially extending support post having a fixed length, the at least one support post including first and second fixation markers axially spaced apart from each other by a fixed distance such that the axial distance between a selected pair of the first and second movable markers can be compared to the fixed distance between the first fixation marker and the second fixation marker.

[0161] Example 25. The prosthetic device of any of the examples herein, particularly example 24, wherein the first and second fixation markers include an aperture extending through a thickness of at least one of the support posts.

[0162] Example 26. A prosthetic device described in any of the examples herein, particularly any one of Examples 24-25, wherein the first and second fixation markers comprise a radiopaque material having a different radiopacity than that of the at least one support post.

[0163] Example 27. A prosthetic device described in any of the embodiments herein, particularly any one of embodiments 21 to 26, wherein a selected first actuator post has a threaded bore and the rod has a threaded portion configured to engage with the threaded bore to connect the rod to the selected first actuator post.

[0164] Example 28. A prosthetic device as described in any of the embodiments herein, particularly any one of embodiments 21 to 26, wherein the selected first actuator post accommodates a nut that is held in a fixed position relative to the selected first actuator post such that the nut does not rotate relative to the selected first actuator post, and the threaded portion of the rod is configured to engage with the internal threads of the nut such that rotation of the rod causes the rod to move axially relative to both the nut and the selected first actuator post.

[0165] Example 29. A prosthetic device described in any of the examples herein, particularly any one of Examples 27-28, wherein the rod is configured to rotate in a first direction to axially compress and radially expand the prosthetic device, and the rod is configured to rotate in an opposite second direction to axially elongate and radially compress the prosthetic device.

[0166] Example 30. A prosthetic device as described in any of the embodiments herein, particularly any one of embodiments 21-29, wherein the rod comprises a stopper positioned adjacent to a first end of the selected second actuator post and a head portion positioned adjacent to a second end of the selected second actuator post, the first end being closer to the selected first actuator post than the second end, and the stopper and head portion being larger than the inner bore of the selected second actuator post.

[0167] Example 31. A prosthetic device comprising a frame comprising first and second axially extending actuator posts axially movable relative to one another, a rod extending through an inner bore of the second actuator post and coupled to the first actuator post and configured to be rotated to radially expand the frame from a radially compressed state to a radially expanded state, and a support post extending parallel to the first and second actuator posts and comprising a pair of first and second fixed markers spaced axially apart from one another by a fixed distance, wherein the first actuator post comprises a first movable marker and the second actuator post comprises a second movable marker, and the distance between the first and second movable markers can be compared to a fixed distance between the first and second fixed markers.

[0168] Example 32. The prosthetic device of any of the examples herein, particularly example 31, wherein the first and second fixation markers include apertures extending through a thickness of the support post.

[0169] Example 33. A prosthetic device described in any of the examples herein, particularly any one of Examples 31-32, wherein the first and second fixation markers comprise a radiopaque material having a radiopacity different from the radiopacity of the support post.

[0170] Example 34. A prosthetic device described in any of the examples herein, particularly any one of Examples 31 to 33, wherein the first and second fixation markers comprise protrusions extending radially inward or outward from the support post.

[0171] Example 35. A prosthetic device as described in any of the examples herein, particularly any one of Examples 31 to 34, wherein the frame further comprises third and fourth axially extending actuator posts axially movable relative to one another, the third actuator post including a third movable marker, and the fourth actuator post including a fourth movable marker, and the positions of the movable markers are configured such that a difference in axial distance between the first movable marker and the second movable marker, and between the third movable marker and the fourth movable marker, can indicate a degree of uniformity of radial expansion of the frame.

[0172] Example 36. A prosthetic device as described in any of the examples herein, particularly any one of examples 31-35, wherein the first and second movable markers have openings extending through the respective first and second actuator posts.

[0173] Example 37. A prosthetic device described in any of the examples herein, particularly any one of Examples 31 to 36, wherein the first and second movable markers comprise a radiopaque material having a radiopacity different from the radiopacity of the first and second actuator posts.

[0174] Example 38. A prosthetic device described in any of the embodiments herein, particularly any one of embodiments 31 to 37, wherein the first and second movable markers include protrusions extending radially inward or outward from the respective first and second actuator posts.

[0175] Example 39. A valve structure comprising: an annular frame having an inflow end and an outflow end; and a valve structure mounted within the frame and configured to regulate blood flow from the inflow end to the outflow end, the frame comprising: a plurality of pairs of axially extending first and second actuator posts, the first and second actuator posts of each pair being axially movable relative to one another; at least one rod extending through an inner bore of a selected one of the second actuator posts and coupled to a selected first actuator post paired with the selected second actuator post, wherein rotation of the rod is configured to radially expand the frame from a radially compressed state to a radially expanded state; and one or more axially extending support posts, at least two first actuator posts comprising respective first moveable markers. and two second actuator posts paired with at least two first actuator posts include respective second movable markers, defining pairs of first and second movable markers, the first and second movable markers of each pair of movable markers being spaced apart from one another by an axial distance that decreases as the frame radially expands, and positions of the first and second movable markers are configured such that as the frame radially expands, a difference between the axial distance of one of the pair of movable markers and the axial distance of the other of the pair of movable markers indicates an evenness of radial expansion of the frame, and at least one support post includes first and second fixation markers spaced apart from one another by a fixed axial distance such that the axial distance between each pair of first and second movable markers can be compared to a fixed distance between the first fixation marker and the second fixation marker as the frame radially expands.

[0176] Example 40. The prosthetic valve of any of the embodiments herein, particularly example 39, wherein the first and second fixation markers include openings extending through a thickness of the at least one support post.

[0177] Example 41. An artificial valve described in any of the examples herein, particularly any one of Examples 39-40, wherein the first and second fixation markers comprise a radiopaque material having a radiopacity different from the radiopacity of at least one support post.

[0178] Example 42. An artificial valve described in any of the embodiments herein, particularly any one of embodiments 39 to 41, wherein the first and second movable markers include openings extending through the thickness of the respective first and second actuator posts.

[0179] Example 43. An artificial valve described in any of the examples herein, particularly any one of Examples 39 to 42, wherein the first and second movable markers comprise a radiopaque material having a radiopacity different from the radiopacity of the first and second actuator posts.

[0180] Example 44. An artificial valve described in any of the examples herein, particularly any one of Examples 39 to 43, wherein the frame comprises an equal number of first actuator posts, second actuator posts, and support posts.

[0181] Example 45. An artificial valve as described in any of the embodiments herein, particularly example 44, wherein the pairs of first and second actuator posts and one or more support posts are arranged in an alternating order around the circumference of the frame.

[0182] Example 46. A prosthesis comprising a frame and a delivery device configured to deliver the prosthesis to a target location, the frame comprising a plurality of axially extending expansion and locking mechanisms and one or more axially extending support posts, each of the expansion and locking mechanisms comprising a pair of first and second actuator posts axially movable relative to one another, and a rod extending through an inner bore of the second actuator post and coupled to the first actuator post, wherein rotation of the rod radially expands the prosthesis from a radially compressed state to a radially expanded state, at least two of the expansion and locking mechanisms comprising respective pairs of the first and second movable markers, the first movable markers being respectively positioned on the first actuator posts of the at least two expansion and locking mechanisms. and wherein the first and second movable markers are positioned on the first and second actuator posts of the at least two expansion and locking mechanisms, respectively, and the positions of the first and second movable markers are configured such that a difference in axial distance between each pair of the first and second movable markers can indicate an evenness of radial expansion of the frame; and the delivery device comprises an outer shaft, a distal end portion of the outer shaft configured to receive the prosthesis in the radially compressed state, at least one actuator assembly extending through the outer shaft and operably connected to the frame; and a handle connected to a proximal end of the outer shaft, the handle comprising a first control mechanism configured to be actuated to move the prosthesis from the distal end of the outer shaft.

[0183] Example 47. An assembly as described in any of the embodiments herein, particularly example 46, wherein at least one of the support posts includes a first fixed marker and a second fixed marker axially spaced apart from each other by a fixed distance, and when the frame is radially expanded, the axial distance of the selected pair of first and second movable markers can be compared to a fixed distance between the first fixed marker and the second fixed marker.

[0184] Example 48. An assembly described in any of the embodiments herein, particularly any one of embodiments 46-47, wherein the at least one actuator assembly comprises a sleeve and a driver releasably coupled to a rod of one of a plurality of expansion and locking mechanisms, each driver configured to rotate the rod to which it is coupled to radially expand or compress the prosthesis.

[0185] Example 49. An assembly as described in any of the embodiments herein, particularly example 48, wherein the handle includes a second control mechanism configured to be actuated to move the sleeve axially relative to the driver to connect or disconnect the actuator assembly from the rod.

[0186] Example 50. An assembly described in any of the embodiments herein, particularly any one of embodiments 48-49, wherein the handle comprises a third control mechanism configured to be actuated to rotate the driver and the rod to radially expand or compress the prosthesis.

[0187] Example 51. A method comprising: radially expanding a prosthesis from a radially compressed state to a radially expanded state; and determining a diameter of the prosthesis as the prosthesis is radially expanded, wherein the frame comprises a pair of first and second fixed markers axially spaced apart from each other by a fixed distance and a pair of first and second movable markers axially movable relative to each other as the frame is radially expanded, and determining the diameter of the prosthesis comprises determining a distance between the first fixed marker and the second movable marker based on the fixed distance between the first fixed marker and the second fixed marker.

[0188] Example 52. A method as described in any of the examples herein, particularly example 51, further comprising monitoring the evenness of expansion as the prosthesis is radially expanded, the frame further comprising a pair of third and fourth movable markers axially movable relative to each other as the frame expands radially, and monitoring the evenness of expansion comprises determining a difference in axial distance between the first and second movable markers and between the third and fourth movable markers.

[0189] Example 53. A method comprising: radially expanding a prosthesis from a radially compressed state to a radially expanded state; and monitoring the evenness of expansion as the prosthesis is radially expanded, wherein the prosthesis comprises a frame, the frame comprising two or more pairs of first and second movable markers, the first and second movable markers of each pair being axially movable relative to each other as the frame radially expands; and monitoring the evenness of expansion comprises detecting a difference in axial distance between the first and second movable markers of each pair, wherein a decrease in the difference indicates an increase in the evenness of expansion and an increase in the distance indicates a decrease in the evenness of expansion.

[0190] Example 54. A method according to any of the examples herein, particularly example 53, further comprising determining a radial diameter of the prosthesis when the prosthesis is radially expanded, the frame further comprising a pair of first and second fixed markers axially spaced apart from each other by a fixed distance, and determining the diameter of the prosthesis comprises determining a distance between the first movable marker and the second movable marker based on the fixed distance between the first fixed marker and the second fixed marker.

[0191] Example 55. A method as described in any of the examples herein, particularly any one of Examples 53-54, further comprising correcting non-uniformity in radial expansion of the prosthesis in response to detecting that the difference in axial distance between each pair of the first and second movable markers exceeds a predetermined threshold, the correction comprising radially compressing the prosthesis, repositioning the prosthesis, and then radially re-expanding the prosthesis while monitoring the uniformity of the expansion.

[0192] Example 56. The method according to any of the examples herein, particularly any one of Examples 51-55, wherein the method comprises implanting a prosthetic device into the heart of a human patient or into a non-living simulated heart.

[0193] Example 57. A method of implanting a prosthesis / valve as described in any of the examples herein, particularly any one of Examples 1-45, wherein the implantation is in a human patient or a non-living body simulation.

[0194] Example 58. A method comprising sterilizing a prosthesis / valve as described in any of the embodiments herein, particularly any one of Examples 1-45, or sterilizing an assembly as described in any of the embodiments herein, particularly any one of Examples 46-50.

[0195] Unless otherwise specified, any feature described herein with respect to any embodiment may be combined with any other feature described in any one or more of the other embodiments, for example, any one or more features of one prosthesis / valve may be combined with any one or more features of another prosthesis / valve.

[0196] In view of the numerous possible embodiments to which the principles of the disclosed technology may be applied, it should be recognized that the illustrated embodiments are merely preferred embodiments of the technology and should not be taken as limiting the scope of the present disclosure. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

1. 1. A prosthetic device comprising: a radially compressible and expandable frame; a frame including two or more pairs of first and second movable markers, the first and second movable markers of the pairs being circumferentially spaced from one another, the first and second movable markers of each pair being axially aligned and axially movable relative to one another as the frame radially expands, such that an axial distance between the first and second movable markers of each pair is variable, and positions of the first and second movable markers are configured such that a difference between the axial distance of one of the first and second movable markers of the pair and the axial distance of the other of the first and second movable markers of the pair can indicate a degree of uniformity of radial expansion of the frame.

2. 2. The prosthetic device of claim 1, wherein the frame includes a plurality of pairs of first and second posts, the pairs of first and second posts being circumferentially spaced apart from one another, the first and second posts of each pair being axially movable relative to one another, the first post of two or more pairs of posts including the first movable marker, and the second post of the two or more pairs of posts including the second movable marker.

3. 3. The prosthetic device of claim 2, wherein each first movable marker includes a first opening extending radially through the thickness of the respective first post, and each second movable marker includes a second opening extending through the thickness of the respective second post.

4. 4. The prosthetic device of claim 2, wherein the first and second movable markers comprise a radiopaque material having a radiopacity different from the radiopacity of the first and second posts.

5. The prosthetic device according to any one of claims 1 to 4, wherein the two or more pairs of first and second movable markers are uniformly distributed around the circumference of the frame.

6. The prosthetic device of any one of claims 1 to 5, wherein the frame comprises six pairs of first and second movable markers.

7. 7. The prosthetic device of any one of claims 1 to 6, further comprising at least one pair of first and second fixed markers axially spaced apart from each other by a fixed distance such that a distance between a selected pair of first and second movable markers can be compared to a fixed distance between the at least one pair of first and second fixed markers.

8. 8. The prosthetic device of claim 7, wherein at least one pair of the first and second fixation markers is located on a third post of the frame that extends parallel to the pairs of first and second posts.

9. 9. The prosthetic device of claim 8, wherein the first and second fixation markers each include an aperture extending through a thickness of the third post.

10. The prosthetic device of any one of claims 8 to 9, wherein the first and second fixation markers comprise a radiopaque material having a radiopacity different from the radiopacity of the third post.

11. 1. A prosthetic device comprising: a radially compressible and expandable frame; 1. A prosthetic device, wherein the frame comprises a pair of first and second fixed markers axially spaced a fixed distance from each other, and a pair of first and second movable markers axially movable relative to each other as the frame radially expands, such that the distance between the pair of first and second movable markers can be compared to the fixed distance between the pair of first and second fixed markers.

12. 12. The prosthetic device of claim 11, wherein the pair of first and second fixation markers are located on axially extending support posts of the frame.

13. The prosthetic device of claim 12 , wherein the first and second fixation markers each include an aperture extending through a thickness of the support post.

14. The prosthetic device of any one of claims 12 to 13, wherein the first and second fixation markers comprise a radiopaque material having a radiopacity different from the radiopacity of the support posts.

15. 15. The prosthetic device of any one of claims 12 to 14, wherein the support post is one of a plurality of support posts, each of the plurality of support posts including a respective pair of the first and second fixation markers having the fixed distance therebetween.

16. 16. The prosthetic device of any one of claims 11 to 15, wherein the frame comprises a plurality of pairs of first and second posts, the first and second posts of each pair being axially movable relative to one another and coupled to the first post of a selected pair of posts, the first post of the selected pair comprising the first movable marker and the second post of the selected pair comprising the second movable marker.

17. 17. The prosthetic device of claim 16, wherein the first movable marker includes a first aperture extending through the first post of the selected pair and the second movable marker includes a second aperture extending through the second post of the selected pair.

18. 18. The prosthetic device of any one of claims 16 to 17, wherein the first and second movable markers comprise a radiopaque material having a radiopacity different from the radiopacity of the first and second posts.

19. 19. The prosthetic device of any one of claims 16 to 18, wherein the frame further comprises a plurality of axially extending third posts, each third post positioned between two pairs of first and second posts, each pair of first and second posts positioned between two third posts, and a plurality of struts extending between and connecting the pairs of first and second posts and the plurality of third posts defining a plurality of cells extending circumferentially around the frame.

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