Prosthetic valve with information indicator

Abstract

The present disclosure relates to a prosthetic valve including an information indicator that may indicate suitable information associated with a previously implanted prosthetic valve. Such an information indicator may be formed internally in a relatively wide support post of a mechanically expandable prosthetic valve, or may be formed externally along a support post of a mechanically expandable prosthetic valve or a vertical post of a balloon expandable prosthetic valve.

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefit of U.S. Provisional Application No. 63 / 354,812, filed on June 23, 2022, which is incorporated herein by reference. Technical Field

[0003] The present disclosure is directed to prosthetic valves that include information indicators that can indicate appropriate information associated with a previously implanted prosthetic valve. Background Art

[0004] Native heart valves, such as the aortic valve, pulmonary valve, and mitral valve, are used to ensure adequate directional flow from and to the heart and between the ventricles to supply blood to the entire cardiovascular system. Various valvular diseases may render the valve ineffective and require replacement with an artificial valve. Surgery can be performed to repair or replace heart valves. Surgery is prone to a large number of clinical complications, so alternative minimally invasive techniques have been developed over the years, whereby a prosthetic valve is delivered via a catheter and implanted over the native faulty valve.

[0005] To date, different types of prosthetic valves are known, including balloon-expandable valves, self-expandable valves, and mechanically expandable valves. Different delivery and implantation methods are also known, and may vary depending on the implantation site and the type of prosthetic valve. An exemplary technique includes utilizing a delivery assembly for delivering a prosthetic valve in a curled state from an incision that may be located at the patient's femoral or iliac arteries toward a native faulty valve. Once the prosthetic valve is correctly positioned at the desired implantation site, it may expand against surrounding body structures (such as the annulus of the native valve), and the delivery assembly may then be retrieved.

[0006] Sometimes, re-intervention may be necessary after a patient has already had an earlier prosthetic valve implanted. In such cases, the clinician needs to know certain characteristics of the previously implanted prosthetic valve to determine the most appropriate course of action. Therefore, there is a need to communicate such characteristics, which may, for example, relate to the manufacturer, type, model, valve size, or any other characteristics of the originally implanted valve, to guide the clinician in selecting the appropriate type of treatment, such as an appropriate replacement prosthetic valve. Summary of the invention

[0007] The present disclosure is directed to prosthetic valves that include information indicators that can indicate appropriate information associated with a previously implanted prosthetic valve. Such information indicators can be formed internally in relatively wide support columns of a mechanically expandable prosthetic valve, or can be formed externally along the support columns of a mechanically expandable prosthetic valve or the vertical struts of a balloon expandable prosthetic valve.

[0008] According to one aspect of the present disclosure, a prosthetic valve comprises: an annular frame movable between a compressed diameter in a radially compressed state and an expanded diameter in a radially expanded state; and a valve structure mounted within the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve. The frame comprises a plurality of intersecting angled struts, a plurality of vertical struts, and at least one externally formed information indicator formed along at least one of the vertical struts.

[0009] In some aspects, each of the plurality of vertical struts extends between a vertical strut inflow end and an opposing vertical strut outflow end.

[0010] In some aspects, the plurality of vertical struts includes a plurality of commissural struts, each commissural strut including a commissural window and a plurality of non-commissural vertical struts, wherein each non-commissural vertical strut lacks a commissural window.

[0011] In some aspects, two of the angled struts intersect each vertical strut inflow end and another two of the angled struts intersect each vertical strut outflow end.

[0012] In some aspects, the width of the externally formed information indicator is at least as great as the width of the vertical strut along which the externally formed information indicator is formed.

[0013] In some aspects, the externally formed information indicator extends from the vertical strut inflow end of at least one of the commissure struts.

[0014] In some aspects, an externally formed information indicator extends from a vertical strut outflow end of at least one of the commissure struts.

[0015] In some aspects, the at least one externally formed information indicator includes at least two externally formed information indicators, one of the at least two externally formed information indicators extending from the vertical strut inflow end of at least one of the commissural struts, and the other of the at least two externally formed information indicators extending from the vertical strut outflow end of the same commissural strut.

[0016] In some aspects, the width of the externally formed information indicator is greater than the width of the vertical strut along which the externally formed information indicator is formed.

[0017] In some aspects, the at least one externally formed information indicator comprises a plurality of externally formed information indicators, at least two of which are different shapes from one another.

[0018] In some aspects, at least one of the externally formed information indicators is in the shape of a letter, and wherein another one of the externally formed information indicators is in the shape of a digit.val.

[0019] In some aspects, the frame further comprises at least two support struts extending between at least two adjacent vertical struts and intersecting each other at a support vertex, and wherein at least one support strut extends from the at least one externally formed information indicator.

[0020] In some aspects, the at least one externally formed information indicator includes an inflow portion coinciding with the inflow end of the vertical strut, an opposing outflow portion, and a central portion disposed between the inflow portion and the outflow portion, wherein the central portion is in the form of a laterally oriented extension.

[0021] In some aspects, the at least one externally formed information indicator includes an inflow portion connected to two of the angled struts, an opposite outflow portion, and a center portion disposed between the inflow portion and the outflow portion, wherein the center portion includes a transverse body extending in a transverse direction and terminating at a bidirectional vertical extension, and two shoulders are formed at a transition portion between the transverse body and the bidirectional vertical extension.

[0022] In some aspects, the at least one externally formed information indicator extends from the vertical strut outflow end of one of the non-commissural vertical struts adjacent one of the commissural struts such that the inflow portion of the externally formed information indicator is axially distal to the outflow edge of the commissural window.

[0023] In some aspects, an axial distance between the inflow portion of the externally formed information indicator and the outflow edge of the commissure window is less than a difference between an axial height of the prosthetic valve in the radially compressed state and an axial height of the prosthetic valve in the radially expanded state.

[0024] In some aspects, the at least one externally formed information indicator includes a first externally formed information indicator formed along one of the vertical struts and a second externally formed information indicator formed along an adjacent vertical strut, wherein the first externally formed information indicator represents a first digit of the expanded diameter of the prosthetic valve and the second externally formed information indicator represents a second digit of the expanded diameter of the prosthetic valve.

[0025] According to one aspect of the present disclosure, a prosthetic valve includes: an annular frame that is movable between a compressed diameter in a radially compressed state and an expanded diameter in a radially expanded state; and a valve structure that is mounted within the frame and includes a plurality of leaflets that are configured to regulate flow through the prosthetic valve. The frame includes: a plurality of actuating posts that include an upper post member and a lower post member; a plurality of support posts; a plurality of actuators coupled to the actuating posts that are configured to adjust the frame between the radially compressed state and the radially expanded state; and at least one information indicator.

[0026] In some aspects, each support column extends between a column inflow end and an opposing column outflow end.

[0027] In some aspects, the at least one information indicator is formed in or along at least one of the support columns.

[0028] In some aspects, the plurality of support posts includes a plurality of commissure support posts, wherein each commissure support post includes a commissure window and a plurality of non-commissure support posts, wherein each non-commissure support post lacks a commissure window.

[0029] In some aspects, the plurality of curved struts extend circumferentially between adjacent actuation and support struts and interconnect the actuation and support struts.

[0030] In some aspects, two of the curved struts intersect each column inflow end and another two of the curved struts intersect each column outflow end.

[0031] In some aspects, each support post intersects at least eight curved struts extending from adjacent actuation posts.

[0032] In some aspects, the information indicator is an internally formed information indicator.

[0033] In some aspects, the width of the support post is greater than the width of the internally formed information indicator formed therein.

[0034] In some aspects, the at least one internally formed information indicator comprises at least two internally formed information indicators formed at different axial locations of at least one of the non-commissural support posts.

[0035] In some aspects, the information indicator is an externally formed information indicator.

[0036] In some aspects, the width of the externally formed information indicator is greater than the width of the support post along which the externally formed information indicator is formed.

[0037] In some aspects, the at least one information indicator includes a first information indicator in one of the support columns and a second information indicator in an adjacent support column, wherein the first information indicator represents a first digit of the expanded diameter of the prosthetic valve and the second information indicator represents a second digit of the expanded diameter of the prosthetic valve.

[0038] According to some aspects of the present disclosure, a prosthetic valve is provided, comprising an annular frame movable between a compressed diameter in a radially compressed state and an expanded diameter in a radially expanded state. The frame comprises a plurality of intersecting angled struts and a plurality of vertical struts, each vertical strut extending between a vertical strut inflow end and an opposing vertical strut outflow end. Two of the angled struts intersect with each vertical strut inflow end, and the other two of the angled struts intersect with each vertical strut outflow end. The frame further comprises at least one information indicator formed in or along at least one of the vertical struts.

[0039] According to some aspects of the present disclosure, a prosthetic valve is provided, which includes an annular frame and a valve structure mounted in the frame. The frame can move between a compressed diameter in a radially compressed state and an expanded diameter in a radially expanded state. The frame includes a plurality of intersecting angled struts and a plurality of vertical struts, wherein each vertical strut extends between a vertical strut inflow end and an opposite vertical strut outflow end. The plurality of vertical struts include a plurality of commissure struts and a plurality of non-commissure vertical struts. Each commissure strut includes a commissure window. Each non-commissure vertical strut does not have a commissure window. The frame further includes at least one externally formed information indicator formed along at least one of the vertical struts. The valve structure includes a plurality of leaflets configured to regulate flow through the prosthetic valve. Two of the angled struts intersect with each vertical strut inflow end, and the other two of the angled struts intersect with each vertical strut outflow end. The width of the externally formed information indicator is at least as large as the width of the vertical strut along which the externally formed information indicator is formed.

[0040] According to some aspects of the present disclosure, a prosthetic valve is provided, which includes an annular frame and a valve structure mounted in the frame. The frame can move between a compressed diameter in a radially compressed state and an expanded diameter in a radially expanded state. The frame includes a plurality of actuating posts, a plurality of support posts, a plurality of curved struts, a plurality of actuators coupled to the actuating posts, and at least one information indicator formed in or along at least one of the support posts. Each support post extends between a post inflow end and an opposite post outflow end. The plurality of support posts include a plurality of commissural support posts and a plurality of non-commissural support posts. Each commissural support post includes a commissural window. Each non-commissural support post does not have a commissural window. The curved struts extend circumferentially between adjacent actuating posts and support posts, and interconnect the actuating posts and support posts. The actuator is configured to adjust the frame between a radially compressed state and a radially expanded state. Two of the curved struts intersect with each post inflow end, and the other two of the curved struts intersect with each vertical strut outflow end. Each support post intersects with at least eight curved struts extending from adjacent actuating posts.

[0041] Aspects of the present disclosure may be used in combination or alone. The present disclosure is provided to introduce some concepts in a simplified form, which will be further described in the following detailed description. This summary is not intended to determine the main structure or basic structure of the subject matter protected by the claims, nor is it intended to be used to limit the scope of the subject matter protected by the claims. The foregoing and other objects, features and advantages of the present invention will become more apparent from the following detailed description with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0042] Some examples of the present invention are described herein with reference to the accompanying drawings. The description together with the accompanying drawings makes it clear to one of ordinary skill in the art how some examples may be implemented. The accompanying drawings are for illustrative purposes and are not intended to show structural details of the examples in more detail than is necessary for a basic understanding of the present invention. For clarity, some objects depicted in the drawings are not drawn to scale.

[0043] In the attached picture:

[0044] Figure 1 is a perspective view of an exemplary mechanical consumable prosthetic valve.

[0045] Figure 2 is a perspective view of a frame of another exemplary mechanical consumable prosthetic valve.

[0046] Figure 3 An exemplary delivery device carrying a mechanically expandable prosthetic valve is shown.

[0047] Figure 4 is a perspective view of a frame of another exemplary mechanical consumable prosthetic valve.

[0048] Figure 5A is a perspective view of an exemplary balloon consumable prosthetic valve.

[0049] Figure 5B yes Figure 5A Perspective view of the frame of a prosthetic valve.

[0050] Figure 6 An exemplary delivery device carrying a balloon-expandable prosthetic valve is shown.

[0051] Fig. 7A is a perspective view of a frame of another exemplary balloon consumable prosthetic valve.

[0052] Figure 7B Shown in a flattened configuration Fig. 7A part of the frame.

[0053] Fig. 8A is a perspective view of a frame of another exemplary balloon consumable prosthetic valve.

[0054] Figure 8B Shown in a flattened configuration Fig. 8A part of the frame.

[0055] Fig. 9 A portion of a frame of another exemplary balloon-consumable prosthetic valve is shown.

[0056] Fig.10 yes Fig. 9 Perspective view of a prosthetic valve.

[0057] Fig.11 A portion of a frame of another exemplary balloon-consumable prosthetic valve is shown.

[0058] Fig. 12A is a perspective view of a frame of another exemplary balloon consumable prosthetic valve.

[0059] Fig. 12B Shown in a flattened configuration Fig. 12A A portion of the frame and an enlarged area of ​​its two information indicators.

[0060] Fig.13 A portion of a frame of another exemplary balloon-consumable prosthetic valve is shown. DETAILED DESCRIPTION

[0061] For the purpose of this description, certain aspects, advantages and novel features of examples of the present disclosure are described herein. The disclosed methods, devices and systems should not be interpreted as limiting in any way. Instead, the present disclosure relates to all novel and non-obvious features and aspects of the various disclosed examples, individually and in various combinations and sub-combinations of each other. The methods, devices and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed examples require the existence of any one or more specific advantages or problem solving. The technology from any example can be combined with the technology described in any one or more examples in other examples. In view of the many possible examples to which the principles of the disclosed technology can be applied, it should be recognized that the examples shown are merely preferred examples and should not be considered to limit the scope of the disclosed technology.

[0062] Although the operations of some disclosed examples are described in a specific sequential order for convenience of presentation, it should be understood that this description includes rearrangement unless the specific language set forth below requires a specific order. For example, in some cases, the operations described in sequence may be rearranged or performed simultaneously. In addition, for simplicity, the accompanying drawings may not show the various ways in which the disclosed methods can be used in combination with other methods. In addition, this specification sometimes uses terms such as "providing" or "implementing" to describe the disclosed methods. These terms are high-level abstractions of the actual operations performed. The actual operations corresponding to these terms may vary depending on the specific implementation and are easily discernible by a person of ordinary skill in the art.

[0063] All features described herein are independent of each other and, unless structurally impossible, can be used in combination with any other features described herein.

[0064] As used in this application and the claims, the singular forms "a", "an", and "the" include the plural forms unless the context clearly dictates otherwise. In addition, the terms "having" or "including" mean "including". Further, the terms "coupled", "connected", and "attached" as used herein are interchangeable and generally mean physical, mechanical, chemical, magnetic, and / or electrical connections or links, and do not exclude the presence of intermediate elements between connected or associated items in the absence of specific language to the contrary. As used herein, "and / or" means "and" or "or", as well as "and" and "or".

[0065] Direction and other relative references may be used to facilitate discussion of the drawings and principles herein, but are not intended to be limiting. For example, certain terms such as "inside," "outside," "upper," "lower," "inboard," "outside," "top," "bottom," "interior," "exterior," "left," "right," etc. may be used. When dealing with relative relationships, particularly with respect to the examples shown, such terms are used to provide some clarity of description where applicable. However, such terms are not intended to imply absolute relationships, positions, and / or orientations. For example, for an object, an "upper" portion may become a "lower" portion simply by flipping the object. Nonetheless, it is still the same portion and the object remains unchanged.

[0066] When used with reference to an element, the term "plurality" or "plural" means two or more of the element. Direction and other relative references (e.g., inside and outside, upper and lower, above and below, left and right, and proximal and distal) may be used to facilitate discussion of the drawings and principles herein but are not intended to be limiting.

[0067] The terms "proximal" and "distal" are defined relative to the position of use of the delivery device. Generally speaking, the end of the delivery device closest to the user of the device is the proximal end, and the end of the delivery device farthest from the user (for example, the end inserted into the patient's body) is the distal end. When used with two spatially separated positions or parts of an object, the term "proximal" may be understood to mean closer to the proximal end of the delivery device or oriented toward the proximal end of the delivery device. When used with two spatially separated positions or parts of an object, the term "distal" may be understood to mean closer to the distal end of the delivery device or oriented toward the distal end of the delivery device. The terms "longitudinal" and "axial" are interchangeable and refer to axes extending in proximal and distal directions, unless otherwise expressly defined.

[0068] It should be understood that the disclosed examples may be suitable for delivery and implantation of prosthetic devices in any native cardiac annulus (e.g., the aortic annulus, pulmonary annulus, mitral annulus, and tricuspid annulus) and may be used with any of a variety of delivery methods (e.g., retrograde, antegrade, transseptal, transventricular, transatrial, etc.).

[0069] To avoid undue clutter with too many reference numerals and leads on a particular figure, some components will be introduced via one or more figures and not expressly identified in each subsequent figure in which the component is included.

[0070] Figure 1A prosthetic valve 100 according to one example is shown. The prosthetic valve 100 can be configured to replace a native heart valve (e.g., an aortic valve, a mitral valve, a pulmonary valve, and / or a tricuspid valve). The prosthetic valve 100 is shown as a mechanically expandable prosthetic valve that can be radially compressed for delivery to an implantation location in a patient's body and then radially expanded to a working diameter at the implantation location. The prosthetic valve 100 can include a frame 104 having an annular shape. The prosthetic valve 100 can further include a valve structure 108 supported within and coupled to the frame 104.

[0071] In an example, the valve structure 108 includes one or more leaflets 112 made of a flexible material and configured to open and close to regulate blood flow. In one example, the valve structure 108 can have three leaflets 112 that can be arranged to fold in a tricuspid arrangement. The leaflets 112 can be made entirely or partially of pericardial tissue (e.g., bovine pericardial tissue), biocompatible synthetic materials, or various other suitable natural or synthetic materials.

[0072] As shown, the frame 104 has an inflow end 116, an outflow end 120, and a central longitudinal axis C extending in a direction from the inflow end 116 to the outflow end 120. The frame 104 may include a plurality of support columns 124 and actuation columns 128 that are aligned with the central longitudinal axis C and spaced apart along the circumference of the frame 104. In one example, the support columns 124 and the actuation columns 128 may be arranged in an alternating manner along the circumference of the frame 104. The frame 104 may further include a plurality of struts 132 that extend circumferentially between adjacent support columns 124 and actuation columns 128 and interconnect the support columns 124 and actuation columns 128. The struts 132, the support columns 124, and the actuation columns 128 define a cell 136 of the frame 104. As shown, the struts 132 may have an angled or curved shape.

[0073] One or more commissure windows 140 may be formed in one or more of the support posts 124 (commissure windows 140 may be formed in one or more of the support posts 124). Figure 1 Hidden in, but similar to Figure 2 The support columns 124 may include a support column 125 as a support column 124 including a commissure window 140 exposed therein. A commissure 144 may be formed at the commissure window 140 to couple the leaflet 112 to the frame 104. The support columns 124 may include a support column 125 as a support column 124 including a commissure window 140, and a non-commissure support column 126 as a support column 124 not including a commissure window. The commissure support columns 125 and the non-commissure support columns 126 may be arranged in an alternating manner along the circumference of the frame 104. In the illustrated example, the frame 104 includes a total of six support columns 124, three of which are commissure support columns 125, and three of which are non-commissure support columns 126.

[0074] One or more of the support columns 124 may further include a cantilevered strut 134 extending to the inflow end 116 of the frame 104. In some examples, the cantilevered strut 134 may extend such that a distal end of the cantilevered strut 134 is aligned or substantially aligned with the inflow end 116 of the frame 104.

[0075] The prosthetic valve 100 may further include one or more skirts or sealing members. For example, the prosthetic valve 100 may include an inner skirt ( Figure 1 104). The inner skirt may serve as a sealing member to prevent or reduce paravalvular leakage, anchor leaflets 112 to frame 104, and / or protect leaflets 112 from damage caused by contact with frame 104 during crimping and during the working cycle of prosthetic valve 100. Prosthetic valve 100 may further include an outer skirt ( Figure 1 Not shown, but for different valve types, it can be roughly similar to Fig.10 924). The outer skirt can serve as a sealing member for the prosthetic valve 100 by sealing against tissue of the native valve annulus and helping to reduce paravalvular leakage through the prosthetic valve 100. The inner and outer skirts can be formed from any of a variety of suitable biocompatible materials, including a variety of synthetic materials, including any of fabrics (e.g., polyethylene terephthalate fabrics) or autologous tissue (e.g., pericardial tissue). More details on the use of skirts or sealing members in prosthetic valves can be found, for example, in U.S. Patent Application No. 62 / 854,702 and PCT Patent Application No. US2020 / 024559, each of which is incorporated herein by reference.

[0076] In some cases, such as Figure 1 As shown in the illustrated example, the inflow edge portions of the leaflets 112 can be attached to cantilevered struts 134 and / or to selected struts 132 of the frame 104. Alternatively or in addition, the cantilevered struts 134 can prevent or mitigate portions of the outer skirt from extending radially inwardly, and thereby prevent or mitigate any flow obstruction through the inflow end 116 of the frame 104 caused by the outer skirt. The cantilevered struts 134 can further act as supports to which portions of the inner and / or outer skirts can be coupled. For example, sutures for connecting the inner and / or outer skirts can be wrapped around the cantilevered struts 134 and / or can extend through orifices formed at end portions of the cantilevered struts 134.

[0077] In some embodiments, the leaflets 112 can be sutured directly to the struts 132 of the frame 104. In other embodiments, the proximal edge portions of the leaflets can be sutured to the inner skirt generally along the scalloped line. The inner skirt can in turn be sutured to the adjacent struts 132 of the frame 104, for example, via one or more sutures.

[0078] Each support post 124, including any commissural support posts 125 or non-commissural support posts 126, extends between a post inflow end 180, which is closer to the inflow end 116 of the valve 100, and a post outflow end 182, which is closer to the outflow end 120 of the valve 100. Two curved struts 132 intersect each support post 124 at the post inflow end 180, which is circumferentially disposed between two adjacent inflow apexes 114, so that the corresponding cantilevered strut 134 can extend distally from the post inflow end 180. Similarly, two curved struts 132 intersect each support post 124 at the post outflow end 182, which is circumferentially disposed between two adjacent outflow apexes 118.

[0079] As further shown, each commissural support column 125 and each non-commissural support column 126 also intersects at its middle portion with two sets of four additional curved struts 132 extending on both sides from the adjacent upper column member 160 and lower column member 164, thereby causing each support column 124, and specifically, each commissural support column 125 and each non-commissural support column 126, to intersect with a total of at least eight curved struts extending from the adjacent actuating column 128.

[0080] In one example, the frame 104 can be adjusted between a radially expanded configuration and a radially compressed configuration by deflecting the struts 132. In one example, the frame 104 (e.g., the posts and struts) can be made of a biocompatible plastic expandable material such that the frame 104 will be able to adjust between a radially expanded configuration and a radially compressed configuration. Suitable examples of plastic expandable materials that can be used to form the frame 104 include, but are not limited to, stainless steel, cobalt-chromium alloys, and / or nickel-titanium alloys (which may also be referred to as "NiTi" or "Nitinol").

[0081] In some examples, one or more actuators 170 can be coupled to the actuation posts 128 and used to adjust the frame 104 between the radially expanded configuration and the radially compressed configuration. In one example, each actuation post 128 can include an upper post member 160 and a lower post member 164 (the terms "upper" and "lower" are relative to the upper and lower portions of the actuation posts 128). Figure 1100 ) which is aligned with the longitudinal axis C and has opposite ends separated by a gap. A respective actuator 170 can be coupled to the post members 160, 164 and can be operated to increase or decrease the gap therebetween so as to radially compress or expand the frame 104. The struts 132 can converge with the upper post member 160 to define an outflow apex 118 at the outflow end 120. The struts 132 can similarly converge with the lower post member 164 to define an inflow apex 114 at the inflow end 116.

[0082] In one example, the actuator 170 can include an actuator stem 172 and an attached actuator head. Figure 1 In the example shown, the actuator rod 172 extends through or into the post members 160, 164 and spans the gap therebetween. Figure 1 In the example shown, the actuator rod 172 is inserted into the upper column member 160 from the outflow end 120, and the actuator head (from Figure 1 Hidden from view in the figure) can be positioned or retained at the outflow apex of the upper column member 160.

[0083] In some examples, the actuator rod 172 is externally threaded. Figure 1 , the lower column member 164 can include a nut 176 having internal threads for threadedly engaging the actuator rod 172. In this case, the actuator rod 172 can be axially translated by rotating the actuator rod 172 relative to the nut 176. In some examples, the actuator rod 172 can slide freely relative to the upper column member 160. In other examples, the actuator rod 172 can threadably engage the upper column member 160. As used herein, the term "axial translation" refers to translation along an axis that coincides with or is parallel to the central longitudinal axis C.

[0084] In one scenario, the actuator rod 172 can be rotated in a first direction to move the upper column member 160 toward the lower column member 164 and thereby reduce the size of the gap therebetween, which can have the effect of radially expanding the frame 104. In another scenario, the lower column member 164 can remain stable while the actuator rod 172 is rotated in a second direction to move the upper column member 160 away from the lower column member 164 and thereby increase the size of the gap therebetween, which can have the effect of radially compressing the frame 104.

[0085] The actuator rod 172 may also include a stopper 178 (e.g., in the form of a nut, washer, or flange) disposed thereon. The stopper 178 may be disposed on the actuator rod 172 such that it is located within the gap therebetween. Furthermore, the stopper 178 may be integrally formed on the actuator rod 172 or fixedly coupled thereto such that it does not move relative to the actuator rod 172. Thus, the stopper 178 may be maintained at a fixed axial position on the actuator rod 172 such that it moves in lockstep with the actuator rod 172.

[0086] When the actuator rod 172 is rotated in a direction configured to collapse the prosthetic valve, the stop 178 moves toward the outflow end 120 of the frame until the stop 178 abuts the inflow end of the upper column member 160. Upon further rotation of the actuator rod 172, the stop 178 can apply a proximally directed force to the upper column member 160 to radially compress the frame 104. Specifically, during crimping / radial compression of the prosthetic valve 100, the actuator rod 172 can be rotated in a direction that causes the stop 178 to push against the inflow end of the upper column member 160 (i.e., provide a proximally directed force to the inflow end), thereby moving the upper column member 160 away from the lower column member 164, and thereby axially extending and radially compressing the prosthetic valve 100.

[0087] In an alternative embodiment, some of the actuator rods 172 can rotate in one direction while other actuator rods 172 rotate in the opposite direction simultaneously to radially expand the frame or radially compress the frame. Such counter-rotation of the actuator rods can be used to help reduce the possibility of the entire frame 104 rotating about the central longitudinal axis C during the rotation of the actuator rods 172 about their respective axes (e.g., when radially expanding the frame 104).

[0088] Additional examples of mechanically expandable valves can be found in International Application No. PCT / US2021 / 052745 and U.S. Provisional Application Nos. 63 / 209904 and 63 / 282463, which are incorporated herein by reference.

[0089] The prosthetic valve disclosed herein includes at least one information indicator formed in or along a portion of a support column or vertical strut of the frame. Since the frame of the prosthetic valve is typically made of a radiopaque material (e.g., a metal material), the boundaries of any such information indicator formed by an opening through the thickness of a component of the frame (e.g., a support column) or by cutting the outer boundaries of a component of the frame (e.g., a vertical strut) to form the desired shape of the indicator can be detected using appropriate clinical imaging techniques, such as fluoroscopy, magnetic resonance imaging (MRI), computed tomography (CT), etc.

[0090] The information indicator can provide the clinician (or any other user) with information about the implanted prosthetic valve, such as one or more of the manufacturer, type, model, valve size, and / or manufacturing date associated with the prosthetic valve. If re-intervention is required, such information can help the clinician determine which replacement prosthetic valve may be compatible, for example, with the original prosthetic valve. In another scenario, such information may be important in an emergency situation to help determine whether the patient has an implanted prosthetic valve, and if so, the manufacturer, type, model, etc. of the prosthetic valve. Any information indicator disclosed herein may be in the form of alphanumeric characters, symbols, or any other geometric shapes.

[0091] For example, a manufacturer may have multiple models of prosthetic valves, each of which may be available in multiple sizes (e.g., 20 mm, 23 mm, 26 mm, 29 mm), which may be expanded to a deployed diameter (e.g., 23 mm for a 23 mm valve) or a range of diameters (e.g., 21-24 mm for a 23 mm valve). The information indicator may indicate the implanted valve diameter, for example, by being shaped like the last digit of the valve size (e.g., "3" for a 23 mm valve). In other examples, two adjacent information indicators may be formed as two digits of the valve size (e.g., for a 23 mm valve, the information indicator is shaped as "2" and "3").

[0092] As shown, the actuation posts 128 are arranged in pairs, each pair including an upper post member 160 and a lower post member 164 that can be axially aligned with each other, and each pair of actuation posts 128 can be connected to a commissural support post 125 on one side thereof, and to a non-commissural support post 126 on the other side, for example, via struts 132. As shown, the support posts 124 disposed between the struts 132 can have a width in the circumferential direction that is greater than the width of other curved or angled struts 132 of the frame 104, so as to improve the structural stability of the frame 104. This unique feature of increased width can be utilized by adding an information indicator 150 formed by an opening through the thickness of one or more of the support posts 124, which is defined between the outer boundaries of the support posts 124.

[0093] Figure 1A mechanically expandable prosthetic valve 100 is shown having at least one non-commissural support post 126 that includes an internally formed information indicator 150. The term "internal formed" as used herein throughout the specification refers to being formed by an opening or cut through the thickness of a support post or vertical strut (as further described below with respect to a balloon expandable prosthetic valve) such that the outer boundary of the opening forming the information indicator is completely defined within the outer boundary of the support post or vertical strut, and more specifically, such that the outer boundary of the information indicator does not form the circumferential boundary of any portion of the support post or vertical strut, but is substantially offset from the circumferential boundary of the support post or vertical strut such that frame material is defined between the circumferential boundary of the information indicator and the circumferential boundary of the support post or vertical strut in which the information indicator is formed. In other words, the internally formed information indicator is formed by creating one or more through openings or voids in the shape of the desired alphanumeric character, symbol, or any other geometric shape of the information indicator.

[0094] like Figure 1 As shown, the non-combined support column 126 may have a width W1 in the circumferential direction (i.e., between its circumferential boundaries), and the information indicator 150 formed therein may have a width W2 in the circumferential direction (i.e., between the circumferential boundaries of the indicator), such that W1 is greater than W2 (W1>W2). As mentioned, Figure 1 The particular frame design shown in and described herein has the advantage of including support posts 124, such as non-commissural support posts 126, having a width that is significantly greater than the width of other curved struts 132 of the frame 104 (e.g., W1 can be at least three times greater than the width of the curved or angled struts 132), allowing internally formed information indicators to be formed in such support posts 124 without requiring changes to the external shape or size of the support posts 124 or any other component of the prosthetic valve 100 used for the end.

[0095] The information indicator 150 may be formed at any location along the length of the non-commissural support column 126. Although an E-shaped information indicator 150 is shown, it should be understood that the information indicator 150 may be in the shape of any other alphanumeric character, symbol, or any other geometric shape. Figure 1 1, but it should be understood that more than one non-commissural support post 126 may include an internally formed information indicator 150, and any non-commissural support post 126 may include more than one internally formed information indicator 150. When multiple internally formed information indicators 150 are included, they may be similarly shaped or differently shaped, for example, to convey different information details of the prosthetic valve 100.

[0096] As described above, the size of the prosthetic valve, i.e., the deployed diameter, can include two digits. In some embodiments, at least one internally formed information indicator indicates the deployed diameter of the prosthetic valve by taking the form of the last digit of the deployed diameter of the prosthetic valve. Since a support column, such as an internally formed non-commissural support column 126, may not provide sufficient space to include two digits, in some embodiments, two adjacent support columns, such as two adjacent non-commissural support columns 126, can each include one of the digits of the two-digit deployed diameter, which can be similar or different from each other. For example, for a prosthetic valve with a deployed diameter of 23 mm, an internally formed information indicator formed in a first non-commissural support column 126 can take the form of a first digit (e.g., "2"), while another internally formed information indicator formed in a second non-commissural support column 126 adjacent to the first non-commissural support column 126 can take the form of a second digit (e.g., "3").

[0097] Figure 2 Another exemplary prosthetic valve 200 is shown without soft components (e.g., a skirt or valve structure) for clarity. The prosthetic valve 200 can be structurally similar to the prosthetic valve 100 described and function in a similar manner as the prosthetic valve described, except that the prosthetic valve 200 is shown as having at least one commissure support post 225 including an information indicator 250 formed therein. For example, the prosthetic valve 200 can include a frame 204 extending between an inflow end 216 and an outflow end 220, the frame 204 including a plurality of actuation support posts 228 defining pairs of upper post members 260 and lower post members 264, and support posts 224 including commissure support posts 225 equipped with commissure windows 240, and non-commissure support posts 226 without commissure windows. The frame 204 may also include a plurality of curved or angled struts 232 extending circumferentially between adjacent support columns 224 , 228 and interconnecting the support columns 224 , 228 , wherein the struts 232 and the support columns 224 , 228 define cells 236 of the frame 204 .

[0098] Each support post 224, including any commissural support posts 225 or non-commissural support posts 226, extends between a post inflow end 280 and a post outflow end 282. Two curved struts 232 intersect each support post 224 at the post inflow end 280, the post inflow end being circumferentially disposed between two adjacent inflow vertices 214, such that a corresponding cantilevered strut 134 can extend distally from the post inflow end 180. Similarly, two curved struts 232 intersect each support post 224 at the post outflow end 282, the post outflow end being circumferentially disposed between two adjacent outflow vertices 218. Other structural and functional components of the prosthetic valve 200 can be similar to those described above with respect to the prosthetic valve 100, wherein like numbers refer to like components and, for the sake of brevity, will not be further described.

[0099] like Figure 2 As shown, the commissure support column 225 can have a width W3 in the circumferential direction, and the information indicator 250 formed therein can have a width W4 in the circumferential direction, so that W3 is greater than W4 (W3>W4). The non-commissure support column 226 can have a width W1 similar to the non-commissure support column 126 described above with respect to the frame 104. For the same reasons described above (i.e., to increase the structural stability of the frame 204), the width W4 of the commissure support column 225 can be similar to the width W1 of the non-commissure support column 226, or in some embodiments, it can be greater than the width W1 of the non-commissure support column 226, for example because it needs to accommodate the commissure window 240 formed therein, which does not exist in the non-commissure support column 226.

[0100] Although in the illustrated example the information indicator 250 is shown as being distal to the union window 240, it should be understood that the internally formed information indicator 250 may be formed at any location along the length of the union support column 225, including proximal to the union window 240 if the union window 240 is a sufficient distance from the column outflow end 282 to accommodate such information indicator 250.

[0101] Although an E-shaped information indicator 250 is shown, it should be understood that the information indicator 250 may be in the shape of any other alphanumeric character, symbol, or any other geometric shape. Figure 2 In each of the three commissure support posts 225 shown, it is understood that any other number of commissure support posts 225 may include an internally formed information indicator 250, and any commissure support post 225 may include more than one internally formed information indicator 250. When multiple internally formed information indicators 250 are included, they may be similarly shaped or differently shaped, for example, to convey different information details of the prosthetic valve 200.

[0102] Although prosthetic valve 100 is shown as including Figure 1 The information indicator 150 is formed inside at least one of the at least one non-commissural support columns 126, and the prosthetic valve 200 is shown as including Figure 2 250, but it should be understood that in other embodiments, the mechanically expandable prosthetic valve 100 or 200 may include at least one internally formed information indicator 150, 250 in at least one non-commissural support column 126, 226 thereof, and at least one internally formed information indicator 150, 250 in at least one commissural support column 125, 225 thereof. In such embodiments, some or all of the plurality of internally formed information indicators 150, 250 may be similarly shaped or differently shaped.

[0103] As mentioned above, since a support column 124, 224, such as a commissure support column 125, 225 or a non-commissure support column 126, 126, may not provide sufficient space to include two digits, in some embodiments, two adjacent support columns 124, 224, such as a commissure support column 125, 225 and an adjacent non-commissure support column 126, 226, may each include one of the digits of a two-digit deployed diameter, which may be similar or different from each other. For example, for a prosthetic valve having a deployed diameter of 23 mm, an information indicator formed within one of the commissure support columns 125, 225 may take the form of a first digit (e.g., "2"), while an information indicator formed within another non-commissure support column 126, 226 adjacent to the commissure support column 125, 225 may take the form of a second digit (e.g., "3").

[0104] Figure 4Another exemplary prosthetic valve 400 is shown without soft components (e.g., a skirt or valve structure) for clarity. The prosthetic valve 400 can be structurally similar to the prosthetic valve 100 described and function in a similar manner as the prosthetic valve described, except that the prosthetic valve 400 can include one or more support posts 424 with at least one externally formed information indicator 450 instead of the internally formed information indicators 150, 250. For example, the prosthetic valve 400 can include a frame 404 extending between an inflow end 416 and an outflow end 420, the frame 404 including a plurality of actuation support posts 428 defining pairs of upper post members 460 and lower post members 464, and support posts 424 including commissure support posts 425 equipped with commissure windows 440, and non-commissure support posts 426 without commissure windows. The frame 404 may also include a plurality of curved or angled struts 432 extending circumferentially between adjacent support columns 424 , 428 and interconnecting the support columns 424 , 428 , wherein the struts 432 and the support columns 424 , 428 define cells 436 of the frame 404 .

[0105] Although in Figure 4 Only one side of the frame 404 is depicted, but it should be understood that the frame 404 forms an annular structure having a Figure 4 4 and 5. The prosthetic valve 400 is shown on substantially the same opposite sides of the portions shown in . Each support column 424, including any commissural support columns 425 or non-commissural support columns 426, extends between a column inflow end 480 and a column outflow end 482. Two curved struts 432 intersect each support column 424 at the column inflow end 480, the column inflow end being circumferentially disposed between two adjacent inflow vertices 414 so that a corresponding cantilevered strut 434 can extend distally from the column inflow end 480. Similarly, two curved struts 432 intersect each support column 424 at the column outflow end 482, the column outflow end being circumferentially disposed between two adjacent outflow vertices 418. Other structural and functional components of the prosthetic valve 400 can be similar to those described above with respect to the prosthetic valve 100, where like numbers refer to like components and, for the sake of brevity, will not be further described.

[0106] As mentioned, the mechanically expandable prosthetic valve 400 has at least one support post 424 that includes an externally formed information indicator 450. The term "externally formed" as used herein throughout this specification refers to being formed by an incision along the outer boundary of at least a portion of the support post or vertical strut, such that the outer boundary forming the information indicator is continuous with the outer boundary defining the remainder of the support post or vertical strut. In other words, the externally formed information indicator is formed by forming an incision along the outer boundary such that the solid material defined between these boundaries is in the shape of the desired alphanumeric character, symbol, or any other geometric shape of the information indicator. The externally formed information indicator of the current specification will have a width in the circumferential direction that is equal to or greater than the width of the remainder of the support post or vertical strut.

[0107] When the support column or support strut is not wide enough (in the circumferential direction) to accommodate an internally formed information indicator, or when the resulting potential internally formed information indicator is relatively small due to the limited width of the support column or vertical strut to form the information indicator, making it more difficult to identify under clinical imaging techniques (e.g., fluoroscopy), an externally formed information indicator may be preferred over an internally formed information indicator because the externally formed information indicator can have a width greater than the width of an optional alternative internally formed information indicator, such as a width similar to, or greater than, the width of the support column or vertical strut.

[0108] The externally formed information indicator of the present specification will extend from the column inflow end or column outflow end of the support column, or from the vertical column inflow end or vertical column outflow end of the vertical column (described in further detail below). The location of the externally formed information indicator extending from the inflow end or outflow end of the support column or vertical column is superior to other axial positions along the support column or vertical column, because such inflow end or outflow end along which the curved or angled columns of the frame converge with the support column or vertical column can improve the structural stability of the resulting information indicator.

[0109] Figure 4The frame 404 in FIG. 4 is shown to show two exemplary externally formed information indicators 450: an information indicator 450a extending from the column inflow end 480 of the commissure support column 424, and an information indicator 450b extending from the column outflow end 482 of the non-commissure support column 426. As shown, the non-commissure support column 426 can have a width W5 in the circumferential direction, and the information indicator 450b formed along it can have a width W6 in the circumferential direction, such that W6 is greater than W5 (W6>W5). The commissure support column 425 can have a width W7 in the circumferential direction, and the information indicator 450a formed along it can have a width W8 in the circumferential direction, such that W8 is greater than W7 (W8>W7). The width W7 of the commissure support post 425 can be similar to the width W5 of the non-commissure support post 426, or in some embodiments, it can be greater than the width W5 of the non-commissure support post 426, for example because it is needed to accommodate the commissure window 440 formed therein, which does not exist in the non-commissure support post 426.

[0110] Although the information indicator 450a is shown extending from the post inflow end 480 of the commissure support post 425, distal to the commissure window 440 in the illustrated example, it should be understood that the externally formed information indicator 450 may similarly extend from the post outflow end 482 of the commissure support post 425, proximal to the commissure window 440, provided that the commissure window 440 is sufficiently distant from the post outflow end 482 to accommodate such information indicator 450. Similarly, although the commissure support post 425 is shown in the illustrated example to include a single externally formed information indicator 450a, in alternative embodiments, the commissure support post 425 may include two externally formed information indicators 450 at opposite ends thereof, one extending from its post inflow end 480 and the other extending from its post outflow end 482.

[0111] While the information indicator 450b is shown as extending from the column outflow end 482 of the non-commissural support column 426 in the illustrated example, it should be understood that the externally formed information indicator 450 may similarly extend from the column inflow end 480 of the non-commissural support column 426. Similarly, while the non-commissural support column 426 is shown in the illustrated example as including a single externally formed information indicator 450b, in alternative embodiments, the non-commissural support column 426 may include two externally formed information indicators 450 at opposite ends thereof, one extending from its column inflow end 480 and the other extending from its column outflow end 482.

[0112] Although Figure 4The frame 404 shown in the figure is shown as including both information indicators 450a formed along the commissure support columns 425 and information indicators 450b formed along the non-commissure support columns 426, but it should be understood that this configuration is shown in an illustrative and non-limiting manner, and the frame 404 can be equipped with one or more commissure support columns 425, wherein the one or more commissure support columns include one or two externally formed information indicators 450, wherein all non-commissure columns 426 do not have any information indicators, or the frame 404 can be equipped with one or more non-commissure support columns 426, wherein the one or more non-commissure support columns include one or two externally formed information indicators 450, wherein all non-commissure support columns 425 do not have any information indicators.

[0113] Although E-shaped information indicators 450a, 450b are shown, it should be understood that any information indicator 450 may be in the shape of any other alphanumeric character, symbol, or any other geometric shape. When multiple information indicators are provided in a single frame 404, such as in the example shown, they may be similarly shaped or differently shaped, such as to convey different information details of the prosthetic valve 400.

[0114] While the prosthetic valves 100 and 200 are shown as including internally formed information indicators 150 and 250, and the prosthetic valve 400 is shown as including an externally formed information indicator 450, it should be understood that in some embodiments, a mechanically expandable prosthetic valve similar to any of the prosthetic valves 100, 200, 400 disclosed above may include a combination of at least one internally formed information indicator 150, 250 and at least one externally formed information indicator 450 formed within or along the same or different support struts. Such a combination embodiment may be useful if the internally formed information indicator is shaped differently from the externally formed information indicator, each indicator being designed to convey different information details, wherein the internally formed information indicator is in the form of an alphanumeric character, symbol, or any other geometric shape that can be formed sufficiently within the boundaries of the support strut without compromising the ability to be properly identified under clinical imaging techniques, while the externally formed information indicator is in the form of an alphanumeric character, symbol, or any other geometric shape that needs to be relatively wide to allow its shape to be properly identified under clinical imaging techniques.

[0115] Figure 3 A delivery device 300 is shown according to one configuration that is suitable for delivering a mechanically expandable prosthetic valve 360 ​​described herein (e.g., prosthetic valves 100, 200, and 400). Prosthetic valve 360 ​​can be releasably coupled to delivery device 300. It should be understood that delivery device 300 can be used to implant prosthetic devices other than prosthetic valves, such as stents or grafts.

[0116] The delivery device 300 in the illustrated example generally includes a handle 304, an outer elongated shaft 308 extending distally from the handle 304, and at least one actuator assembly 320 extending distally through the outer shaft 308. The delivery device 300 may also include an elongated nose cone shaft 332 extending distally from the handle 304 through the outer shaft 308. The nose cone 340 may be connected to the distal end of the nose cone shaft 332. The at least one actuator assembly 320 may be configured to radially expand and / or radially collapse the prosthetic valve 360 ​​when actuated.

[0117] As shown, one actuator assembly 320 may be provided for each actuator (e.g., actuator 170, 270, or 470) on a prosthetic valve 360. For example, six actuator assemblies 320 may be provided for a prosthetic valve 360 ​​having six actuators. However, in other configurations, any greater or lesser number of actuator assemblies may be present.

[0118] The distal portion of shaft 308 can be sized and shaped to accommodate prosthetic valve 360 ​​in a radially compressed delivery state during delivery of the prosthetic valve through, for example, the vasculature of a patient. In this way, the distal portion of shaft 308 serves as a delivery sheath or capsule for the prosthetic valve during delivery.

[0119] The actuator assembly 320 can be releasably coupled to the prosthetic valve 360. For example, in the illustrated configuration, each actuator assembly 320 can be coupled to a corresponding actuator of the prosthetic valve 360. Each actuator assembly 320 can include a support tube 324, an actuator member (in Figure 3 The actuator assembly 320 may be concealed in the support tube 324) and optionally include a locking tool. When actuated, the actuator assembly may transmit thrust and / or tension to portions of the prosthetic valve to radially expand and collapse the prosthetic valve as previously described. The actuator assembly 320 may be at least partially radially disposed within one or more lumens of the outer shaft 308 and extend axially through the lumens. For example, the actuator assembly 320 may extend through the central lumen of the shaft 308 or through a separate corresponding lumen formed in the shaft 308.

[0120] As used herein, the terms "releasably coupled" or "releasably attached" are interchangeable and refer to two components that are coupled in such a manner that they are coupled together and can be separated without plastically deforming either component.

[0121] Although not shown, in some embodiments, the delivery device 300 can include a multi-lumen delivery shaft that extends through the lumen of the outer shaft and has multiple lumens therein. Either of the nose cone shaft 332 and / or the actuation assembly 320 can extend through the lumen of the multi-lumen delivery shaft.

[0122] The actuator member of each actuator assembly 320 can be releasably coupled to a corresponding actuator of the prosthetic valve (e.g., actuator 170, 270, or 470). The support tube 324 of each actuator assembly 320 can abut an adjacent portion of the frame of the prosthetic valve, such as an outflow apex (e.g., apex 118, 218, or 418). In this way, during valve expansion, the support tube 324 can prevent movement of the outflow end of the prosthetic valve relative to the delivery device, while the actuator member of the actuator assembly 320 can actuate the actuator of the prosthetic valve and move the inflow end of the prosthetic valve toward the outflow end of the prosthetic valve.

[0123] The handle 304 of the delivery device 300 can include one or more control mechanisms (e.g., knobs 306 or other actuation mechanisms) for controlling the various components of the delivery device 300 in order to expand and / or deploy the prosthetic valve 360. For example, in the example shown, the handle 304 includes a first knob 306a, a second knob 306b, and a third knob 306c.

[0124] The first knob 306a can be a rotatable knob configured to produce axial movement of the outer shaft 308 relative to the prosthetic valve 360 ​​in a distal direction and / or a proximal direction so as to deploy the prosthetic valve from the delivery sheath once the prosthetic valve has been advanced to a position at or adjacent to the desired implantation site in the patient. For example, rotating the first knob 306a in a first direction (e.g., clockwise) can retract the sheath proximally relative to the prosthetic valve 360, and rotating the first knob 306a in a second direction (e.g., counterclockwise) can advance the sheath distally. In other configurations, the first knob 306a can be actuated by axially sliding or moving the knob 306a, such as pulling and / or pushing the knob. In still other examples, actuating first knob 306a, such as by rotating or sliding first knob 306a, can produce axial movement of actuator assembly 320, and thus prosthetic valve 360, relative to the delivery sheath to advance the prosthetic valve distally from the sheath.

[0125] The second knob 306b can be a rotatable knob configured to produce radial expansion and / or contraction of the prosthetic valve 360. For example, the rotation of the second knob 306b can cause the actuator member of the actuator assembly 320 and the support tube 324 to move axially relative to each other. The actuator member of the assembly 320 then causes the corresponding movement of the actuator (e.g., actuator 170, 270 or 470) of the prosthetic valve. The rotation of the second knob 306b in a first direction (e.g., clockwise) can cause the prosthetic valve 360 ​​to expand radially, and the rotation of the second knob 306b in a second direction (e.g., counterclockwise) can cause the prosthetic valve 360 ​​to collapse radially. In other configurations, the second knob 306b can be actuated by axially sliding or moving the knob 306b, such as pulling and / or pushing the knob.

[0126] The third knob 306c can be a rotatable knob configured to keep the prosthetic valve 360 ​​in an expanded state. For example, the third knob 306c can be operably connected to the proximal portion of the locking tool of each actuator assembly 320. Rotating the third knob 306b in a first direction (e.g., clockwise) can rotate each locking tool so that the locking nut advances to its distal position to resist the radial compression of the frame of the prosthetic valve. Rotating the knob 306c in the opposite direction (e.g., counterclockwise) can rotate each locking tool in the opposite direction to disengage each locking tool from the prosthetic valve 360. In other configurations, the third knob 306b can be actuated by axially sliding or moving the third knob 306b, such as pulling and / or pushing the knob. In some instances, the prosthetic valve can be self-locking, in which case, a locking tool is not required. For example, the frame of the prosthetic valve may include locking features that automatically engage the actuator member of the prosthetic valve after expansion of the prosthetic valve to resist radial compression of the prosthetic valve, such as disclosed in US Application Nos. 63 / 085,947, 63 / 138,599, and 63 / 179,766.

[0127] Although not shown, the handle 304 can include a fourth rotatable knob operatively connected to the proximal portion of each actuator member. The fourth knob can be configured to rotate each actuator member when the knob is rotated to unscrew each actuator member from the proximal portion of the corresponding actuator. As described above, once the locking tool and the actuator member are disconnected from the prosthetic valve 360, the locking tool and the actuator member can be removed from the patient.

[0128] Figure 5A-5BAnother example of a prosthetic valve 500 is shown. The prosthetic valve 500 can be configured to replace a native heart valve (e.g., an aortic valve, a mitral valve, a pulmonary valve, and / or a tricuspid valve). The prosthetic valve 500 is shown as a balloon-expandable prosthetic valve that can move between a radially compressed state and a radially expanded state. A balloon-expandable valve generally involves a procedure of inflating a balloon within the prosthetic valve to expand the prosthetic valve 500 within a desired implantation site. The prosthetic valve 500 can include a frame 504 having an annular shape. The prosthetic valve 500 can further include a valve structure 508 supported within and coupled to the frame 504. The valve structure 508 can include one or more leaflets 512, which can be the same as any of the examples described above with respect to the valve structure 108 and the leaflets 112, and for the sake of brevity, a detailed description thereof will not be repeated here. Figure 5A A prosthetic valve 500 is shown having a valve structure 508, and Figure 5B The frame 504 is shown without the valve structure.

[0129] like Figure 5A As further shown in FIG. 5 , the frame 504 has an inflow end 516, an outflow end 520, and a central longitudinal axis C extending in a direction from the inflow end 516 to the outflow end 520. The frame 504 can be made of various suitable materials, including plastically deformable materials, such as but not limited to stainless steel, nickel-based alloys (e.g., cobalt-chromium or nickel-cobalt-chromium alloys, such as MP35N alloy), polymers, or combinations thereof. When made of a plastically deformable material, the frame 504 can be placed in the balloon catheter 652 ( Figure 6 ) is curled into a radially compressed state and then expanded in the patient's body by an inflatable balloon. Alternatively or additionally, the frame 504 can be made of a shape memory material, such as but not limited to a nickel-titanium alloy (e.g., Nitinol).

[0130] The frame 504 includes a plurality of intersecting struts, including curved or angled struts 532 and vertical struts 528. The frame 504 includes a plurality of strut steps that may collectively define one or more rows of cells 536, wherein the vertical struts 528 in the illustrated example may be formed along the uppermost or nearest row of cells 536. The frame 504 may have a cylindrical or substantially cylindrical shape having a constant diameter from the inflow end 516 to the outflow end 520 as shown, or the diameter of the frame may vary along the central longitudinal axis C, as disclosed in U.S. Pat. No. 9,155,619, which is incorporated herein by reference.

[0131] The end portions of the angled struts 532 form an outflow apex 518 at the outflow end 520 and an inflow apex 514 at the inflow end 516. The struts may intersect at additional junctions formed between the outflow apex 518 and the inflow apex 514. The junctions may be equally or unequally spaced from each other between the outflow end 520 and the inflow end 516 and / or equally or unequally spaced from the apexes 518, 514.

[0132] The vertical struts 528 may include commissure struts 529 and non-commissure vertical struts 530. The commissure struts 529 include commissure windows 540 that can accommodate commissures 544 of the valve structure 508, while the non-commissure vertical struts 530 do not have commissure windows. Each vertical strut 528, including any commissure struts 529 or non-commissure vertical struts 530, extends between a vertical strut inflow end 580 closer to the inflow end 516 of the valve 500 and a vertical strut outflow end 582 closer to the outflow end 520 of the valve 500. Two curved or angled struts 532 intersect each vertical strut 528 at a vertical strut inflow end 580 , which is circumferentially disposed between two adjacent inflow vertices 514 , and two curved or angled struts 532 intersect each vertical strut 528 at a vertical strut outflow end 582 , which is circumferentially disposed between two adjacent outflow vertices 518 .

[0133] The prosthetic valve 500 may also include an inner skirt (not shown) and / or an outer skirt ( Figure 5A-5B Not shown, but may be substantially similar to Fig.10 ), which may be implemented according to any of the embodiments described for prosthetic valve 100, and for the sake of brevity, a detailed description thereof will not be repeated here.

[0134] The width (in the circumferential direction) of the non-commissural vertical struts or the width of the sidewalls at both sides of the commissural windows in the commissural struts are generally narrowed to fully accommodate the internally formed information indicators therein. Therefore, the balloon-expandable prosthetic valve disclosed in the present specification preferably includes an information indicator formed on the outside of a portion of its vertical struts, extending from the vertical strut inflow end or the vertical strut outflow end to provide improved structural stability due to the angled or curved struts converging therewith, and preferably has no internally formed information indicators.

[0135] Figure 5A-5BA balloon expandable prosthetic valve 500 is shown having non-commissural vertical struts 530 including an externally formed information indicator 550 extending from its vertical strut inflow end 580. As shown, the non-commissural vertical struts 530 can have a width W9 in the circumferential direction, and the information indicator 550 formed along the non-commissural vertical struts 530 can have a width W10 in the circumferential direction, such that W10 is greater than W9 (W10>W9). In some embodiments, the non-commissural vertical struts 530, which are narrower than the information indicator 550, can be aligned with one circumferential side of the information indicator 550, as shown in the example shown, or it can be aligned with the circumferential center (not shown) of the information indicator 550.

[0136] Although the information indicator 550 is Figure 5A-5B 550 is shown as wider than the non-combined vertical struts 530, but in other embodiments (not shown), the width of the externally formed information indicator 550 can be equal to the width of the non-combined vertical struts 530 (i.e., W9=W10). However, the wider information indicator 550 can be advantageously used as a support member to which other components can be attached. For example, in some embodiments, sensors (e.g., pressure sensors, flow sensors, temperature sensors, and the like) can be coupled to the information indicator 550.

[0137] Although the information indicator 550 is shown as extending from the vertical strut inflow end 580 of the non-commissural vertical strut 530 in the illustrated example, it should be understood that the externally formed information indicator 550 may similarly extend from the vertical strut outflow end 582 of the non-commissural vertical strut 530. Similarly, although each non-commissural vertical strut 530 is shown as including a single externally formed information indicator 550 in the illustrated example, in alternative embodiments, the non-commissural vertical strut 530 may include two externally formed information indicators 550 at its opposite ends, one extending from its vertical strut inflow end 580 and the other extending from its vertical strut outflow end 582. However, in some embodiments, it may be advantageous to form the information indicator 550 at the vertical strut inflow end 580. As shown, the upper row of cells includes larger cells 536 than the cells of other rows of the prosthetic valve. A frame designed with taller outflow cells 536 can create more open space for blood flow and coronary artery access. Where the width W10 of the information indicator 550 is greater than the width W9 of the non-combined vertical struts 530, forming a wider information indicator 550 at the vertical strut inflow end 580 advantageously provides more open space (not blocked by the wider information indicator) at the outflow end of the frame to increase blood flow and coronary artery access.

[0138] Although an E-shaped information indicator 550 is shown, it should be understood that the externally formed information indicator 550 may be in the shape of any other alphanumeric character, symbol, or any other geometric shape. Figure 5B In the illustrated example, a single externally formed information indicator 550 is shown as being formed along three non-combined vertical struts 530, but it should be understood that any other number of non-combined vertical struts 530 may include one or two externally formed information indicators 550. When multiple externally formed information indicators 550 are included, they can be similarly shaped or differently shaped, for example to convey different information details of the prosthetic valve 500. In some embodiments, one or more information indicators can also serve as a support structure to which the soft components of the prosthetic valve can be connected. For example, portions of the skirt (e.g., inner skirt and / or outer skirt) and / or leaflets of the prosthetic valve can be sutured to portions of one or more information indicators.

[0139] As mentioned above, since a support post, such as an internally formed non-commissural support post 526, may not provide sufficient space to include two digits, in some embodiments, two adjacent support posts, such as two adjacent non-commissural support posts 526, may each include one of the digits of a two-digit deployed diameter, which may be similar or different from each other. For example, for a prosthetic valve having a deployed diameter of 23 mm, an externally formed information indicator formed on a first non-commissural support post 526 may take the form of a first digit (e.g., "2"), while another externally formed information indicator formed on a second non-commissural support post 526 adjacent to the first non-commissural support post 126 may take the form of a second digit (e.g., "3").

[0140] Figure 7A-7B Another exemplary prosthetic valve 700 is shown, which is shown without soft components (e.g., skirt or valve structure) for clarity. The prosthetic valve 700 can be similar in structure to the prosthetic valve 500 described and function in a similar manner to the prosthetic valve described, except that the prosthetic valve 700 is shown with commissure struts 729 including externally formed information indicators 750 extending from their respective vertical strut inflow ends 780. For example, the prosthetic valve 700 can include a frame 704 extending between an inflow end 716 and an outflow end 720, the frame 704 including a plurality of vertical struts 728, the plurality of vertical struts including commissure struts 729 equipped with commissure windows 740, and non-commissure vertical struts 730 without commissure windows. The frame 704 may also include a plurality of curved or angled struts 732 that intersect with other angled struts 732 and interconnect the vertical struts 728 , wherein the struts 732 and the vertical struts 728 define cells 736 of the frame 704 . Fig. 7A The ring configuration of the frame 704 is shown, and Figure 7B A portion of the frame 704 is shown in a flattened configuration for illustration purposes.

[0141] Each vertical strut 728, including any commissural struts 729 or non-commissural vertical struts 730, extends between a vertical strut inflow end 780 that is closer to the inflow end 716 of the valve 700 and a vertical strut outflow end 782 that is closer to the outflow end 720 of the valve 700. Two curved or angled struts 732 intersect each vertical strut 728 at the vertical strut inflow end 780, which is circumferentially disposed between two adjacent inflow apexes 714, and two curved or angled struts 732 intersect each vertical strut 728 at the vertical strut outflow end 782, which is circumferentially disposed between two adjacent outflow apexes 718. Other structural and functional components of the prosthetic valve 700 may be similar to those described above with respect to the prosthetic valve 500, wherein like numbers refer to like components and, for the sake of brevity, will not be further described.

[0142] like Figure 7A-7B , both the commissure struts 729 and the information indicator 550 may have a common equal width W12 in the circumferential direction. In other embodiments, the width of the information indicator 550 may be greater than the width of the commissure struts 729. The non-commissure vertical struts 730 may have a width W11 in the circumferential direction, which may be similar to the width of the commissure struts 729, or narrower than the width of the commissure struts 729 because the non-commissure vertical struts 730 do not include commissure windows 740.

[0143] In some embodiments, as shown for frame 704, one or more of the non-combined vertical struts 730 may have a vertical strut inflow end 780 that is widened relative to its middle portion (relative to W11). In some embodiments, the vertical strut inflow end 780 of the non-combined vertical strut 730 may include an orifice 742. The orifice 742 may be configured to receive a fastener (e.g., a suture) to attach the soft component of the prosthetic valve 700 to the frame 704. For example, in some embodiments, the outer skirt can be positioned around the outer surface of the frame 704 and fixed to the orifice 742. Although the non-combined vertical struts 730 including the widened vertical strut inflow end 780 with the orifice 742 are shown and described with respect to the prosthetic valve 700, it should be understood that the prosthetic valve 500 and any other balloon-expandable prosthetic valve disclosed herein may include at least one non-combined vertical strut, the at least one non-combined vertical strut including a widened vertical strut inflow end with an orifice.

[0144] Although an E-shaped information indicator 750 is shown, it should be understood that the information indicator 750 may be in the shape of any other alphanumeric character, symbol, or any other geometric shape. Fig. 7A In the illustrated example, it is shown as being formed along all three commissure posts 729 , but it should be understood that any other number of commissure posts 729 may include externally formed information indicators 750 .

[0145] Figures 8A-8B Another exemplary prosthetic valve 800 is shown, which is shown without soft components (e.g., skirt or valve structure) for clarity. Prosthetic valve 800 can be structurally similar to the described prosthetic valves 500 or 700 and function in a similar manner as the described prosthetic valves, except that prosthetic valve 800 is shown with commissure struts 829 including externally formed information indicators 850 extending from their respective vertical strut outflow ends 880. For example, prosthetic valve 800 can include a frame 804 extending between an inflow end 816 and an outflow end 820, the frame 804 including a plurality of vertical struts 828, the plurality of vertical struts including commissure struts 829 equipped with commissure windows 840, and non-commissure vertical struts 830 without commissure windows. The frame 804 may also include a plurality of curved or angled struts 832 that intersect with other angled struts 832 and interconnect vertical struts 828 , wherein the struts 832 and vertical struts 828 define cells 836 of the frame 804 . Fig. 8A A ring configuration of frame 804 is shown, and Figure 8B A portion of the frame 804 is shown in a flattened configuration for illustration purposes.

[0146] Each vertical strut 828, including any commissural struts 829 or non-commissural vertical struts 830, extends between a vertical strut inflow end 880 that is closer to the inflow end 816 of the valve 800 and a vertical strut outflow end 882 that is closer to the outflow end 820 of the valve 800. Two curved or angled struts 832 intersect each vertical strut 828 at the vertical strut inflow end 880, which is circumferentially disposed between two adjacent inflow apexes 814, and two curved or angled struts 832 intersect each vertical strut 828 at the vertical strut outflow end 882, which is circumferentially disposed between two adjacent outflow apexes 818. Other structural and functional components of the prosthetic valve 800 may be similar to those described above with respect to the prosthetic valves 500 or 700, where like numbers refer to like components and, for the sake of brevity, will not be further described.

[0147] like Figures 8A-8BAs shown in , the commissure struts 829 may have a width W14 in the circumferential direction, and the externally formed information indicator 850 may have a width W15 in the circumferential direction, such that W15 may be substantially equal to W14 (W15=W14), as shown in the illustrated example, or W15 may be greater than W14 (W15>W14). The non-commissure vertical struts 830 may have a width W13 in the circumferential direction, which may be similar to the width W14 of the commissure struts 829, or narrower than the width W14, because the non-commissure vertical struts 830 do not include the commissure windows 840. As further shown, at least one non-commissure vertical strut 830 may optionally include a widened vertical strut inflow end 880 having an orifice 842.

[0148] Although an E-shaped information indicator 850 is shown, it should be understood that the information indicator 850 may be in the shape of any other alphanumeric character, symbol, or any other geometric shape. Fig. 8A In the illustrated example, it is shown as being formed along all three commissure posts 829 , but it should be understood that any other number of commissure posts 829 may include externally formed information indicators 850 .

[0149] Although in Figure 7A-7B FIG. 7 shows a commissure strut 729 having an information indicator 750 extending from its vertical strut inflow end 780, and Figures 8A-8B 829 having an information indicator 850 extending from its vertical strut outflow end 882, but it should be understood that these features can be combined so that one or more commissure struts will include an externally formed information indicator extending from its vertical strut inflow end, while one or more other commissure struts will include an externally formed information indicator extending from its vertical strut outflow end. In addition, in some embodiments, any such framework may include one or more commissure struts, the one or more commissure struts being equipped with two information indicators disposed at either side thereof, one of which extends from its vertical strut inflow end and the other from its vertical strut outflow end. In addition, the frame of the balloon consumable valve may include a combination of one or more commissure struts and at least one non-commissure vertical strut, the one or more commissure struts having one or two externally formed information indicators formed along them, and the at least one non-commissure vertical strut having one or two externally formed information indicators formed along them. When multiple externally formed information indicators are included, they may be similarly shaped or differently shaped.

[0150] Figure 9-10Another exemplary prosthetic valve 900 is shown. The prosthetic valve 900 can be similar in structure to the prosthetic valve 700 described and function in a similar manner to the prosthetic valve described, except that the prosthetic valve 900 also includes support struts 970, as will be explained in more detail below. For example, the prosthetic valve 900 can include a frame 904 extending between an inflow end 916 and an outflow end 920, the frame 904 including a plurality of vertical struts 928, the plurality of vertical struts including commissure struts 929 equipped with commissure windows 940, and non-commissure vertical struts 930 without commissure windows. The frame 904 can also include a plurality of curved or angled struts 932 that intersect with other angled struts 932 and interconnect the vertical struts 928, wherein the struts 932 and the vertical struts 928 define cells 936 of the frame 904. Fig. 9 A portion of the flattened configuration of the frame 904 is shown, while Fig.10 An annular configuration of a prosthetic valve 900 is shown, including a valve structure 908 having leaflets 912 and an outer skirt 924 disposed about a frame 904 .

[0151] Each vertical strut 928, including any commissural struts 929 or non-commissural vertical struts 930, extends between a vertical strut inflow end 980 that is closer to the inflow end 916 of the valve 900 and a vertical strut outflow end 982 that is closer to the outflow end 920 of the valve 900. Two curved or angled struts 932 intersect each vertical strut 928 at the vertical strut inflow end 980, which is circumferentially disposed between two adjacent inflow apexes 914, and two curved or angled struts 932 intersect each vertical strut 928 at the vertical strut outflow end 982, which is circumferentially disposed between two adjacent outflow apexes 918. Other structural and functional components of the prosthetic valve 900 may be similar to those described above with respect to the prosthetic valve 700, wherein like numbers refer to like components and, for the sake of brevity, will not be further described.

[0152] like Fig. 9As shown, the commissure struts 929 include an externally formed information indicator 950 extending from their respective vertical strut outflow end 980, distal to the commissure window 940. Although each commissure strut 929 is shown as including a single information indicator 950 extending from the vertical strut outflow end 980, in some embodiments, at least one commissure strut 929 may include two externally formed information indicators 950 at opposite ends thereof, one extending from its vertical strut inflow end 980 and the other extending from its vertical strut outflow end 982. Additionally, although all non-commissure vertical struts 930 are shown without any information indicators, in some embodiments, at least one non-commissure vertical strut 930 of the frame 904 may also further include one or two externally formed information indicators 950.

[0153] Fig.10 An outer skirt 924 is shown disposed about and attached to the outer surface of the frame 904. The outer skirt 924 can be secured to the frame 904 by one or more sutures 926, which can be encircled by angled struts 932 of the frame 904. While the inflow end portion of the outer skirt 924 can be sutured to the angled struts 932 along the inflow end 916 of the prosthetic valve 900, the outflow end 922 of the outer skirt 924 is disposed along an upper or proximal row of cells 936, which are typically axially longer than other cells 936 of the frame 904 because these cells contain vertical struts 928, thereby creating a large opening defined by the upper row of cells 936. Such enlarged cell openings create gaps that do not provide adequate support for the outflow end 922 of the outer skirt 924, which may cause portions of the outer skirt 924 to protrude slightly radially inward through these cell openings, or may limit the overall height of the outer skirt 924 to terminate at its outflow end 922, below the opening of the uppermost cell 936.

[0154] like Fig. 9 As shown, the frame 904 further includes support struts 970, which can be bent or angled support struts, so that at least two support struts 970 extend between at least two adjacent vertical struts 928 and intersect each other at a support vertex 972, and the support vertex can be axially aligned with the corresponding outflow vertex 918, and at least one support strut 370 extends from an externally formed information indicator 950.

[0155] Some shapes of externally formed information indicators, such as E-shaped or 3-shaped information indicators, may include portions that may advantageously serve as structural base members from which support struts may extend in a stable manner. Fig. 9The information indicator 950 formed on the outside of the E-shape shown in the figure may include: an inflow portion 958 at its end, which coincides with the vertical strut inflow end 980 connected to the two angled struts 932; an outflow portion 956 at its opposite end, which is closer to the connection window 940; and a central portion 954 arranged between the inflow portion and the outflow portion, which is in the form of a transversely (or circumferentially) oriented extension.

[0156] As shown, at least one support strut 970 may extend from the central portion 954 and intersect another support strut 970 extending from an adjacent non-commissural vertical strut 930. In some embodiments, the non-commissural vertical strut 930 includes a short lateral extension 946 from which the corresponding support strut 970 may extend. As shown, if two support struts 970 extend in opposite directions from the same non-commissural vertical strut 930, the non-commissural vertical strut 930 may include two lateral extensions 946 oriented in opposite lateral directions (perpendicular to the axial direction of the vertical strut 930) to support the two support struts 970 extending therefrom. The lateral extensions 946 may be axially aligned with the corresponding central portion 954 of the information indicator 950.

[0157] Preferably, the frame 904 includes two support struts 970 that intersect each other between every two adjacent vertical struts 928 along the upper or nearest row of cells 936. Fig.10 As shown, the outflow end 922 of the outer skirt 924 can be attached to the support strut 970, for example, via sutures 926. Fig. 9 As further shown, because the support struts 970 are primarily used to support the external skirt attachment, they do not need to bear significant loads or experience the same stress levels as the other struts 932 of the frame 904, and therefore can be relatively narrower and / or thinner than the other angled struts 932, thereby avoiding the risk of significantly increasing the curling profile of the prosthetic valve 900 during delivery.

[0158] Fig.11A portion of a flattened configuration of a frame 1004 of another exemplary prosthetic valve 1000 is shown. Prosthetic valve 1000 can be structurally similar to and function in a similar manner to the described prosthetic valve 900, except that at least one support strut 1070 extends from an outflow portion 1056 of an externally formed information indicator 1050 rather than a central portion thereof. For example, prosthetic valve 1000 includes a frame 1004 extending between an inflow end 1016 and an outflow end 1020, the frame 1004 including a plurality of vertical struts 1028, the plurality of vertical struts including commissure struts 1029 equipped with commissure windows 1040, and non-commissure vertical struts 1030 without commissure windows. The frame 1004 may also include a plurality of curved or angled struts 1032 that intersect with other angled struts 1032 and interconnect the vertical struts 1028 , wherein the struts 1032 and the vertical struts 1028 define cells 1036 of the frame 1004 .

[0159] Each vertical strut 1028, including any commissural struts 1029 or non-commissural vertical struts 1030, extends between a vertical strut inflow end 1080 that is closer to the inflow end 1016 of the valve 1000 and a vertical strut outflow end 1082 that is closer to the outflow end 1020 of the valve 1000. Two curved or angled struts 1032 intersect each vertical strut 1028 at the vertical strut inflow end 1080, the vertical strut inflow end being circumferentially disposed between two adjacent inflow apexes 1014, and two curved or angled struts 1032 intersect each vertical strut 1028 at the vertical strut outflow end 1082, the vertical strut outflow end being circumferentially disposed between two adjacent outflow apexes 1018.

[0160] The commissure struts 1029 include externally formed information indicators 1050 extending from their respective vertical strut outflow ends 1080, distal to the commissure window 1040. The frame 1004 further includes support struts 1070, which may be curved or angled support struts such that at least two support struts 1070 extend between at least two adjacent vertical struts 1028 and intersect each other at support apex 1072, which may be axially aligned with the corresponding outflow apex 1018, and wherein at least one support strut 1070 extends from the externally formed information indicator 1050. The information indicator 1050, shown as an E-shaped indicator in the illustrated example (but may have other shapes in other examples), may include an inflow portion 1058 at its end connected to the two angled struts 1032, an outflow portion 1056 at its opposite end closer to the commissure window 1040, and a central portion 1054 disposed between the inflow portion and the outflow portion in the form of a transversely (or circumferentially) oriented extension. Other structural and functional components of prosthetic valve 1000 may be similar to those described above with respect to prosthetic valve 900 , where like numerals refer to like components and, for the sake of brevity, will not be further described.

[0161] As mentioned above and in Fig.11 , at least one support strut 1070 may extend from the outflow portion 1056 and intersect another support strut 1070 extending from an adjacent non-commissural vertical strut 1030. In some embodiments, the non-commissural vertical strut 1030 includes a short lateral extension 1046 from which the corresponding support strut 1070 may extend. As shown, if two support struts 1070 extend in opposite directions from the same non-commissural vertical strut 1030, the non-commissural vertical strut 1030 may include two lateral extensions 1046 oriented in opposite lateral directions (perpendicular to the axial direction of the vertical strut 1030) to support the two support struts 1070 extending therefrom. The lateral extensions 1046 may be axially aligned with the corresponding outflow portion 1056 of the information indicator 1050. Fig.11 The configuration shown in may be better than Fig. 9 , because, for example, the outflow portion 1056, which may also serve as a portion of the inflow end of the continuous extension to form the commissure window 1040, will provide a more rigid and stable support for the support struts 1070 extending therefrom compared to the central portion 1054.

[0162] Preferably, the frame 1004 includes two support struts 1070 that intersect each other between every two adjacent vertical struts 1028 along the upper or most proximal row of cells 1036. The outflow end portion of the outer skirt may be as described above with respect to Fig.10 Attached to support strut 1070 in the same manner as described above. Fig.11 As further shown, because the support struts 1070 are primarily used to support the external skirt attachment, they do not need to bear significant loads or experience the same stress levels as the other struts 1032 of the frame 1004, and therefore can be relatively narrower and / or thinner than the other angled struts 1032, thereby avoiding the risk of significantly increasing the curling profile of the prosthetic valve 1000 during delivery.

[0163] Although each commissure strut 1029 is shown as including a single information indicator 1050 extending from a vertical strut outflow end 1080, in some embodiments, at least one commissure strut 1029 may include two externally formed information indicators 1050 at opposite ends thereof, one extending from its vertical strut inflow end 1080 and the other extending from its vertical strut outflow end 1082. Additionally, although all non-commissure vertical struts 1030 are shown without any information indicators, in some embodiments, at least one non-commissure vertical strut 1030 of the frame 1004 may also further include one or two externally formed information indicators 1050.

[0164] Figures 12A-12B Another exemplary prosthetic valve 1100 is shown, which is shown without soft parts (e.g., skirt or valve structure) for clarity. In addition to the features described below, the prosthetic valve 1100 can be similar in structure to the described prosthetic valve 700 and function in a manner similar to the described prosthetic valve. For example, the prosthetic valve 1100 may include a frame 1104 extending between an inflow end 1116 and an outflow end 1120, the frame 1104 including a plurality of vertical struts 1128, the plurality of vertical struts including commissure struts 1129 equipped with commissure windows 1140, and non-commissure vertical struts 1130 without commissure windows. The frame 1104 may also include a plurality of curved or angled struts 1132 that intersect with other angled struts 1132 and interconnect the vertical struts 1128, wherein the struts 1132 and the vertical struts 1128 define a unit 1136 of the frame 1104. Fig. 12A The ring configuration of the frame 1104 is shown, and Fig. 12B A portion of the frame 1104 is shown in a flattened configuration for illustration purposes.

[0165] Each vertical strut 1128, including any commissural struts 1129 or non-commissural vertical struts 1130, extends between a vertical strut inflow end 1180 that is closer to the inflow end 1116 of the valve 1100 and a vertical strut outflow end 1182 that is closer to the outflow end 1120 of the valve 1100. Two curved or angled struts 1132 intersect each vertical strut 1128 at the vertical strut inflow end 1180, the vertical strut inflow end being circumferentially disposed between two adjacent inflow apexes 1114, and two curved or angled struts 1132 intersect each vertical strut 1128 at the vertical strut outflow end 1182, the vertical strut outflow end being circumferentially disposed between two adjacent outflow apexes 1118. Other structural and functional components of prosthetic valve 1100 may be similar to those described above with respect to prosthetic valve 700 , where like numbers refer to like components and, for the sake of brevity, will not be further described.

[0166] In the illustrated example, the frame 1104 is shown to include two types of differently formed information indicators 1150, such as an E-shaped information indicator 1150a extending from the inflow portion 1180 of the commissure struts 1129, and a 3-shaped information indicator 1150b extending from the outflow portion 1182 of the non-commissure vertical struts 1130. However, it should be understood that this combination is shown by way of illustration and not limitation, and the frame 1104 may include more or fewer information indicators 1150 formed similarly or differently, wherein each externally formed information indicator 1150 may be in the shape of any other alphanumeric character, symbol, or any other geometric shape.

[0167] Although the information indicator 1150b is Fig. 12A In the illustrated example, the information indicator 1150a is shown as being formed along all six non-jointed vertical struts 1130, but it should be understood that any other number of non-jointed vertical struts 1130 may include an externally formed information indicator 1150b. Similarly, although the information indicator 1150a is shown as being formed along all six non-jointed vertical struts 1130, it should be understood that any other number of non-jointed vertical struts 1130 may include an externally formed information indicator 1150b. Fig. 12A In the illustrated example, this is formed along all three commissure posts 1129, but it should be understood that any other number of commissure posts 1129 may include externally formed information indicators 1150a.

[0168] While the information indicator 1150a is shown as extending from the vertical strut inflow end 1180 of the commissure struts 1129 in the illustrated example, it should be understood that the externally formed information indicator 1150a may similarly extend from the vertical strut outflow end 1182 of the commissure struts 1129. Similarly, while each commissure strut 1129 is shown in the illustrated example as including a single externally formed information indicator 1150a, in alternative embodiments, the commissure struts 1129 may include two externally formed information indicators 1150a at opposite ends thereof, one extending from the vertical strut inflow end 1180 thereof and the other extending from the vertical strut outflow end 1182 thereof.

[0169] Although the information indicator 1150b is shown as extending from the vertical strut outflow end 1182 of the non-commissural vertical strut 1130 in the illustrated example, it should be understood that the externally formed information indicator 1150b may similarly extend from the vertical strut inflow end 1180 of the non-commissural vertical strut 1130. Similarly, although each non-commissural vertical strut 1130 is shown in the illustrated example as including a single externally formed information indicator 1150b, in alternative embodiments, the non-commissural vertical strut 1130 may include two externally formed information indicators 1150b at opposite ends thereof, one extending from its vertical strut inflow end 1180 and the other extending from its vertical strut outflow end 1182.

[0170] like Fig. 12B As shown in , the non-commissural vertical strut 1130 may have a width W16 in the circumferential direction, and the information indicator 1150b formed along the outer portion thereof may have a width W17 in the circumferential direction, such that W17 is greater than W16 (W17>W16). The commissural strut 1129 may have a width W19 in the circumferential direction, and the information indicator 1150a formed along the outer portion thereof may have a width W18 in the circumferential direction, such that W18 may be substantially equal to W19 (W18=W19), as shown in the illustrated example, or W18 may be greater than W19 (W18>W19). The width W19 of the commissural strut 1129 may be equal to the width W16 of the non-commissural vertical strut 1130, or, as shown, W19 may be greater than W16 because the non-commissural vertical strut 1130 does not include a commissural window 1140. As further shown, at least one non-commissural vertical strut 1130 may optionally include a widened vertical strut inflow end 1180 having an aperture 1142 .

[0171] In some instances, information indicators 1150b formed along the exterior of the non-commissural vertical struts 1130 can protect the leaflets during crimping. When the prosthetic valve 1100 is placed in a crimping device to radially compress the valve to a smaller diameter for insertion into a patient, the leaflets of the valve are pressed against the inner surface of the metal frame 1104, and portions of tissue (e.g., in the case of leaflets made of tissue material) can protrude between the struts into the open cells of the frame and can be clamped due to the scissor-like motion of the struts of the frame. If the valve is severely crimped to achieve a small crimp size, this scissor-like motion can result in cutting and rupture of the tissue leaflets.

[0172] In the illustrated example, the wider information indicator 1150b may have a width designed to limit the size of the curling so as to maintain a minimum space between adjacent vertical struts 1128 in the circumferential direction. Specifically, when the prosthetic valve 1100 curls, adjacent vertical struts move closer to each other, possibly clamping the leaflet material protruding through the cell openings therebetween. However, when the information indicator 1150 contacts an adjacent information indicator 1150 or an adjacent vertical strut 1128, the approach of the vertical struts 1128 toward each other will stop. Specifically, when an information indicator 1150b formed on the outside of a non-commissural vertical strut 1130 will contact another information indicator 1150b of an adjacent non-commissural vertical strut 1130, or when it will contact an adjacent commissural strut 1129, compression of the prosthetic valve 1100 will stop.

[0173] If the curling is stopped when two adjacent information indicators 1150b of two adjacent non-commissural vertical struts 1130 contact each other, the resulting minimum lateral space between the adjacent non-commissural vertical struts 1130 will be equal to the difference between the widths W17 and W16 (i.e., W17-W16). If the curling is stopped when the information indicator 1150 contacts the adjacent commissural struts 1129, the resulting minimum lateral space between the adjacent non-commissural vertical struts 1130 and the commissural struts 1129 will be equal to half of the difference between the widths W17 and W16 (i.e., [W17-W16] / 2). If a fold of the leaflet extends through such a space formed between adjacent vertical struts 1128, this space may need to be large enough to accommodate two layers of the folded portions that overlap each other. Therefore, twice the thickness Tl of the leaflet should be able to extend between adjacent vertical struts 1128 without being forcibly clamped. In some embodiments, the difference (W17-W16) is at least twice the thickness Tl of the leaflet. In some embodiments, half of this difference (i.e., [W17-W16] / 2) is at least twice as large as the thickness T1 of the leaflet, meaning that the difference (W17-W16) is at least four times as large as the thickness T1 of the leaflet. In some cases, the tissue material (e.g., pericardium) of the leaflet can be squeezed to about at least half of its free (i.e., un-squeezed) thickness without causing long-term damage to the tissue material. In such cases, the difference (W17-W16) can be at least as large as the thickness T1 of the leaflet (if the leaflet extends between two adjacent non-commissural vertical struts 1130), or at least as large as twice the thickness T1 of the leaflet (if the leaflet extends between the non-commissural vertical struts 1130 and the commissural struts 1129).

[0174] Although the above describes optional interactions between adjacent information indicators 1150b of two adjacent non-commissural vertical struts 1130 or between an information indicator 1150b of a non-commissural vertical strut 1130 and an adjacent commissural strut 1129, for commissural struts that do not include an information indicator 1150 at the same axial position as the axial position of the information indicator 1150b of the non-commissural vertical strut 1130, it should be understood that in alternative embodiments, curling may be stopped when the information indicator 1150b of the non-commissural vertical strut 1130 contacts an adjacent information indicator 1150a formed at the same axial position of the commissural strut 1129. For example, the commissural strut 1129 may include an information indicator 1150a extending from a vertical strut outflow end 1182 thereof, the information indicator being configured to approach until completely contacting an adjacent information indicator 1150b extending from a vertical strut outflow end 1182 of an adjacent non-commissural vertical strut 1130 during curling. It may be advantageous if the information indicator 1150a of the commissure post 1129 has a width W18 that is greater than the width W19 of the commissure post 1129 .

[0175] When the information indicators 1150 are further used as stops to limit the minimum crimp diameter of the prosthetic valve 1000 as described above, it may be preferred that they extend from the vertical strut outflow ends 1182, as shown by the information indicator 1150b in the illustrated example, which is positioned at approximately the axial height of the leaflets to prevent such leaflets from being accidentally clamped by the information indicator 1150 itself. A frame such as frame 1104 of a prosthetic valve comprising interconnected angled struts shortens during expansion such that its length designated as H1 in the expanded state is less than its length designated as H2 in the crimped state (i.e., H1 < H2). The leaflets of the valve structure may include relatively tall tabs that extend through commissure windows to form commissures such that the outflow ends of the remainder of the leaflets may extend radially inwardly and slightly distally from the respective commissures 1144 in the axial direction. Since the frame 1104 elongates during crimping, the outflow portions of the leaflets may extend further proximally in the crimped state of the prosthetic valve.

[0176] To mitigate the risk of leaflet material being clamped between the information indicator 1150b extending from the vertical strut outflow end 1182 of the non-commissural vertical strut 1130 and the sidewall of the commissure window 1140 adjacent the commissural strut 1129, a minimum distance L1 may be defined between the outflow edge 1138 of the commissure window 1140 and the lower end of the information indicator 1150b that may be defined by its inflow portion 1158. Thus, L1 may be defined as the outflow edge 1138 of the commissure window and the inflow portion 1158 of the information indicator 1150b extending from the vertical strut outflow end 1182 of the adjacent non-commissural vertical strut 1130. In some embodiments, the distance L1 is less than the height difference of the frame 1104 between its crimped and expanded states (i.e., L1 < H2 - H1). The axial heights H1 or H2 are measured between the inflow end 1116 and the outflow end 1120.

[0177] As described above with respect to the externally formed information indicators 950 and 1050, some information indicators may be shaped to include a central portion in the form of a laterally oriented free end extension. In Fig. 12B An enlarged section of shows two such shapes, namely the E-shaped information indicator 1150a and the 3-shaped information indicator 1150b, each information indicator comprising an inflow portion 1158 at the end connected to two angled struts 1132, an outflow portion 1156 at its opposite end, and a central portion 1154 in the form of a laterally oriented extension disposed between the inflow portion and the outflow portion.

[0178] In some embodiments, the center portion 1154 can further serve as a structural element to which soft components of the prosthetic valve 1100, such as an inner skirt, an outer skirt, or a leaflet, can be attached, for example, by being sutured to the structural element. However, if the center portion is formed as a free end extension having a uniform width (defined between the proximal and distal edges of the center portion), the suture looped thereon or bound thereto can slip from its free end. In order to prevent the suture from slipping from the center portion of the information indicator, in some embodiments, the center portion can further include a transverse body 1160 extending in a transverse direction (e.g., substantially parallel to the outflow portion 1156 and / or the inflow portion 1158) and terminating at a bidirectional vertical extension 1162 at the free end of the center portion 1154. The bidirectional vertical extension 1162 can be perpendicular to the transverse body 1160, extending from the free end of the center portion 1154 in the proximal and distal directions. This creates two shoulders 1164 formed at the transition from the lateral body 1160 to the bi-directional vertical extensions 1162, which can be used to better retain the sutures attached to the center portion 1154 and prevent them from slipping away from the center portion.

[0179] Fig.13 A portion of a flattened configuration of a frame 1204 of another exemplary prosthetic valve 1200 is shown. The prosthetic valve 1200 can be structurally similar to any of the prosthetic valves 500, 500, 700, 800, 900, 1000, and 1100 described above and function in a similar manner to the prosthetic valves described above. For example, the prosthetic valve 1200 includes a frame 1204 extending between an inflow end 1216 and an outflow end 1220, the frame 1204 including a plurality of vertical struts 1228, the plurality of vertical struts including commissure struts 1229 equipped with commissure windows 1240, and non-commissure vertical struts 1230 without commissure windows. The frame 1204 may also include a plurality of curved or angled struts 1232 that intersect with other angled struts 1232 and interconnect the vertical struts 1228, wherein the struts 1232 and the vertical struts 1228 define cells 1236 of the frame 1204.

[0180] Each vertical strut 1228, including any commissural struts 1229 or non-commissural vertical struts 1230, extends between a vertical strut inflow end 1280 that is closer to the inflow end 1216 of the valve 1200 and a vertical strut outflow end 1282 that is closer to the outflow end 1220 of the valve 1200. Two curved or angled struts 1232 intersect each vertical strut 1228 at the vertical strut inflow end 1280, the vertical strut inflow end being circumferentially disposed between two adjacent inflow apexes 1214, and two curved or angled struts 1232 intersect each vertical strut 1228 at the vertical strut outflow end 1282, the vertical strut outflow end being circumferentially disposed between two adjacent outflow apexes 1218. Other structural and functional components of prosthetic valve 1200 may be similar to those described above with respect to any of the prosthetic valves 500, 500, 700, 800, 900, 1000, and 1100 described above, where like numbers refer to similar components and, for the sake of brevity, will not be further described.

[0181] As mentioned above, since a vertical strut 1228, such as a commissural strut 1229 or a non-commissural vertical strut 1230, may not provide sufficient space to include two digits, in some embodiments, two adjacent vertical struts 1228, such as a commissural strut 1229 and an adjacent non-commissural vertical strut 1230, or any two adjacent non-commissural vertical struts 1230, may each include one of the digits of a two-digit deployed diameter, which may be similar or different from each other. In the illustrated example, for a prosthetic valve having a deployed diameter of 23 mm, one externally formed information indicator 1250a formed on a non-commissural vertical strut 1230a may take the form of a first digit (e.g., "2"), while another externally formed information indicator 1250b formed on a second non-commissural vertical strut 1230b adjacent to the first non-commissural vertical strut 1230a may take the form of a second digit (e.g., "3"). In another example (not shown), the information indicator 1250 formed on one of the commissure struts 1229 may take the form of a first digit (e.g., "2"), while the information indicator 1250 formed on the other of the non-commissure vertical struts 1230 adjacent to the commissure struts 1229 may take the form of a second digit (e.g., "3"). Although the prosthetic valve 1200 is described and shown as including at least two externally formed information indicators 1250 along two adjacent vertical struts 1228, it should be understood that any such combination may be implemented with respect to any of the prosthetic valves 500, 500, 700, 800, 900, 1000, and 1100 described above, mutatis mutandis.

[0182] Although described with respect to the balloon-expandable prosthetic valve 1100, it should be understood that the externally formed information indicators of other prosthetic valves disclosed herein, including any one of the information indicators 550, 750, 850 and 1050 of the balloon-expandable prosthetic valves 500, 700, 800 and 1000, respectively, and the information indicator 450 of the mechanically expandable prosthetic valve 400, can be similarly designed to include a central portion having a lateral body terminating in bidirectional vertical extensions, with the necessary modifications.

[0183] Figure 6 A delivery device 600 is shown according to one configuration suitable for delivering a balloon-expandable prosthetic valve 660 described herein (eg, prosthetic valves 500, 700, 800, 900, 1000, and 1100). It should be appreciated that the delivery device 600 may be used to implant prosthetic devices other than prosthetic valves, such as stents or grafts.

[0184] The delivery device 600 includes a handle 604 and a balloon catheter 652 having an inflatable balloon 650 mounted on the distal end thereof. A balloon-expandable prosthetic valve 660 may be carried in a crimped state over the balloon catheter 652. Optionally, an outer delivery shaft 624 may extend concentrically over the balloon catheter 652, and a push shaft 620 is disposed over the balloon catheter 652, optionally between the balloon catheter 652 and the outer delivery shaft 624.

[0185] The outer delivery shaft 624, the push shaft 620, and the balloon catheter 652 can be configured to be axially movable relative to each other. For example, proximally oriented movement of the outer delivery shaft 624 relative to the balloon catheter 652 or distally oriented movement of the balloon catheter 652 relative to the outer delivery shaft 624 can expose the prosthetic valve 660 from the outer delivery shaft 624. The delivery device 600 can further include a lumen extending through the balloon catheter 652 (from the Figure 6 Nose cone 640 is carried by a nose cone shaft (hidden from view in FIG. 1 ). Nose cone 640 and nose cone shaft may be the same as nose cone 340 and nose cone shaft 332 described for delivery device 300, and for the sake of brevity, a detailed description thereof will not be repeated here.

[0186] The proximal ends of the balloon catheter 652, outer delivery shaft 624, push shaft 620, and optional nose cone shaft can be coupled to the handle 604. During delivery of the prosthetic valve 660, the handle 604 can be manipulated by an operator (e.g., a clinician or surgeon) to axially advance or retract components of the delivery device 600, such as the nose cone shaft, balloon catheter 652, outer delivery shaft 624, and / or push shaft 620 through the patient's vascular system, to inflate the balloon 650 mounted on the balloon catheter 652 to expand the prosthetic valve 660, and to deflate the balloon 650 and retract the delivery device 600 once the prosthetic valve 660 is installed in the implantation site.

[0187] The handle 604 may include a steering mechanism configured to adjust the curvature of the distal end portion of the delivery device 600. In the example shown, the handle 604 includes an adjustment member, such as the rotatable knob 660a shown, which is then operatively connected to the proximal end portion of the pull line. The pull line can extend distally from the handle 604 through the outer delivery shaft 624 and have a distal end portion attached to the outer delivery shaft 624 at or near the distal end of the outer delivery shaft 624. Rotating the knob 660a can increase or decrease the tension in the pull line, thereby adjusting the curvature of the distal end portion of the delivery device 600. Further details about the steering or flexure mechanism for the delivery device can be found in U.S. Patent No. 9,339,384, which is incorporated herein by reference. The handle 604 may further include an adjustment mechanism, which includes an adjustment member, such as the rotatable knob 606b shown. The adjustment mechanism can be configured to adjust the axial position of the push shaft 620 relative to the balloon catheter.

[0188] The prosthetic valve 660 can be carried by the delivery device 600 in a crimped state during delivery and expanded by balloon inflation to secure the prosthetic valve in the native heart valve annulus. In an exemplary implantation procedure, the prosthetic valve 660 is initially crimped above the balloon catheter 652, close to the inflatable balloon 650. Because the prosthetic valve 660 is crimped at a different position than the position of the balloon 650, the prosthetic valve 660 can be crimped into a lower profile than it would be if it were crimped on top of the balloon 650. This lower profile permits the clinician to more easily navigate the delivery device 600 (including the crimped prosthetic valve 660) through the patient's vascular system to the treatment site. The lower profile of the crimped prosthetic valve is particularly helpful when navigating through a particularly narrow portion of the patient's vascular system, such as the iliac arteries.

[0189] Balloon 650 can be fixed to balloon catheter 652 at its balloon proximal end and fixed to balloon catheter 652 or nose cone 640 at its distal end. The distal end portion of push shaft 620 is positioned proximal to the outflow end of prosthetic valve 660 (e.g., outflow ends 520, 720, 820, 920, 1020, and 1120).

[0190] When the implantation site is reached, and before the balloon is inflated, the push shaft 620 is advanced distally, allowing its distal end portion to contact and push against the outflow end of the prosthetic valve 660, thereby pushing the valve 660 distally. The distal end of the push shaft 620 is sized to engage with the outflow end of the prosthetic valve 660 in the curled configuration of the valve. In some embodiments, the distal end portion of the push shaft 620 can be radially flared outward to terminate at a wider diameter that can contact the prosthetic valve 660 in the curled state. Then, the push shaft 620 can be advanced distally to push the prosthetic valve 660 until the curled prosthetic valve 660 is disposed around the balloon 650, at which point the balloon 650 can be inflated to radially expand the prosthetic valve 660. Once the prosthetic valve 660 is expanded to its functional diameter within the native valve annulus, the balloon 650 can be deflated and the delivery device 600 can be retrieved from the patient.

[0191] In some instances, the delivery device 300 or 600 on which the prosthetic valve 360 ​​or 660 is assembled, respectively, can be packaged in a sterile package that can be supplied to an end user for storage and final use. In some instances, the leaflets of the prosthetic valve (typically made of bovine pericardium tissue or other natural or synthetic tissue) are processed during the manufacturing process so that they are completely or substantially dehydrated and can be stored in a partially or completely curled state without a hydrating fluid. In this way, the package containing the prosthetic valve 360 ​​or 660 and the delivery device 300 or 600, respectively, can be free of any liquid. Methods for processing tissue leaflets for dry storage are disclosed in U.S. Pat. Nos. 8,007,992 and 8,357,387, both of which are incorporated herein by reference.

[0192] Some Examples of Disclosed Technologies

[0193] Some examples of the technology described above are listed below. It should be noted that one feature of a separate example or one or more features of an example adopted in combination, and optionally combined with one or more features of one or more other examples, are additional examples that also fall within the disclosure of this application.

[0194] Example 1. A prosthetic valve, comprising:

[0195] An annular frame, the annular frame being movable between a compressed diameter in a radially compressed state and an expanded diameter in a radially expanded state, the frame comprising:

[0196] a plurality of intersecting angled struts and a plurality of vertical struts, wherein each vertical strut extends between a vertical strut inflow end and an opposing vertical strut outflow end, and wherein the plurality of vertical struts comprises:

[0197] a plurality of commissure posts, each commissure post comprising a commissure window; and

[0198] a plurality of non-commissural vertical struts, wherein each non-commissural vertical strut is devoid of a commissural window;

[0199] at least one externally formed information indicator formed along at least one of said vertical struts; and

[0200] a valve structure mounted within the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve;

[0201] wherein two of the angled struts intersect each vertical strut inflow end and another two of the angled struts intersect each vertical strut outflow end; and

[0202] Wherein the width of said externally formed information indicator is at least as great as the width of said vertical strut along which said externally formed information indicator is formed.

[0203] Example 2. A prosthetic valve according to any example herein, in particular Example 1, wherein the externally formed information indicator extends from the vertical strut inflow end of at least one of the commissure struts.

[0204] Example 3. The prosthetic valve of any example herein, particularly Example 1, wherein the externally formed information indicator extends from the vertical strut outflow end of at least one of the commissure struts.

[0205] Example 4. A prosthetic valve according to any example herein, in particular Example 1, wherein the at least one externally formed information indicator includes at least two externally formed information indicators, one of the at least two externally formed information indicators extending from the vertical strut inflow end of at least one of the commissural struts, and the other of the at least two externally formed information indicators extending from the vertical strut outflow end of the same commissural strut.

[0206] Example 5. A prosthetic valve according to any example herein, in particular any one of examples 2 to 4, wherein the at least one externally formed information indicator comprises a plurality of externally formed information indicators formed along a plurality of commissural struts.

[0207] Example 6. A prosthetic valve according to any example herein, particularly any one of examples 1 to 5, wherein the externally formed information indicator extends from a vertical strut inflow end of at least one of the non-commissural vertical struts.

[0208] Example 7. A prosthetic valve according to any example herein, particularly any one of examples 1 to 5, wherein an externally formed information indicator extends from a vertical strut outflow end of at least one of the non-commissural vertical struts.

[0209] Example 8. A prosthetic valve according to any example herein, in particular any one of Examples 1 to 5, wherein the at least one externally formed information indicator includes at least two externally formed information indicators, one of the at least two externally formed information indicators extending from the vertical strut inflow end of at least one of the non-combined vertical struts, and the other of the at least two externally formed information indicators extending from the vertical strut outflow end of the same non-combined vertical strut.

[0210] Example 9. A prosthetic valve according to any example herein, in particular any one of examples 6 to 8, wherein the at least one externally formed information indicator comprises a plurality of externally formed information indicators formed along a plurality of non-commissural vertical struts.

[0211] Example 10. A prosthetic valve according to any example herein, in particular any one of examples 1 to 9, wherein the width of the externally formed information indicator is greater than the width of the vertical strut along which the externally formed information indicator is formed.

[0212] Example 11. A prosthetic valve according to any example herein, particularly Example 7, wherein the width of the externally formed information indicator is greater than the width of the non-commissural vertical struts on which the externally formed information indicator is formed.

[0213] Example 12. A prosthetic valve according to any example herein, in particular Example 11, wherein the difference between the width of the externally formed information indicator and the width of the non-commissural vertical struts is at least as great as the thickness of the leaflet.

[0214] Example 13. A prosthetic valve according to any example herein, in particular Example 11, wherein the difference between the width of the externally formed information indicator and the width of the non-commissural vertical struts is at least twice as large as the thickness of the leaflet.

[0215] Example 14. A prosthetic valve according to any example herein, in particular Example 11, wherein the difference between the width of the externally formed information indicator and the width of the non-commissural vertical struts is at least four times greater than the thickness of the leaflet.

[0216] Example 15. A prosthetic valve according to any example herein, in particular any one of Examples 1 to 14, wherein the at least one externally formed information indicator comprises a plurality of externally formed information indicators, at least two of the plurality of externally formed information indicators being of different shapes from each other.

[0217] Example 16. A prosthetic valve according to any example herein, in particular Example 15, wherein at least one of the externally formed information indicators is in the shape of a letter, and wherein another of the externally formed information indicators is in the shape of a digit.

[0218] Example 17. A prosthetic valve according to any example herein, in particular any one of Examples 1 to 17, wherein the frame further comprises at least two support struts extending between at least two adjacent vertical struts and intersecting each other at a support vertex, and wherein at least one support strut extends from at least one externally formed information indicator.

[0219] Example 18. A prosthetic valve according to any example herein, in particular Example 17, wherein the at least one externally formed information indicator includes an inflow portion coinciding with the inflow end of the vertical strut, an opposite outflow portion, and a central portion disposed between the inflow portion and the outflow portion, wherein the central portion is in the form of a laterally oriented extension.

[0220] Example 19. The prosthetic valve of any example herein, in particular Example 18, wherein support struts extending from an externally formed information indicator extend from a central portion thereof.

[0221] Example 20. The prosthetic valve of any example herein, in particular Example 18, wherein support struts extending from an externally formed information indicator extend from an outflow portion thereof.

[0222] Example 21. A prosthetic valve according to any example herein, in particular any one of Examples 17 to 20, wherein at least one of the vertical struts from which the support struts extend is a non-commissural vertical strut, and the non-commissural vertical struts further include a lateral extension portion from which a corresponding support strut extends.

[0223] Example 22. A prosthetic valve according to any example herein, in particular any one of Examples 17 to 21, wherein the width of each support strut is less than the width of any of the angled struts.

[0224] Example 23. A prosthetic valve according to any example herein, in particular any one of Examples 17 to 22, wherein the support struts include two support struts extending between every two adjacent vertical struts.

[0225] Example 24. A prosthetic valve according to any example herein, in particular any one of examples 17 to 23, further comprising an outer skirt disposed around the frame and attached to the support struts.

[0226] Example 25. A prosthetic valve according to any example herein, in particular any one of Examples 1 to 16, wherein the at least one externally formed information indicator includes an inflow portion connected to two of the angled struts, an opposite outflow portion, and a central portion disposed between the inflow portion and the outflow portion, wherein the central portion includes a transverse body extending in a transverse direction and terminating at a bidirectional vertical extension portion, and two shoulders are formed at a transition portion between the transverse body and the bidirectional vertical extension portion.

[0227] Example 26. A prosthetic valve according to any example herein, in particular any one of Examples 1 to 16, wherein at least one externally formed information indicator extends from the vertical strut outflow end of one of the non-commissural vertical struts adjacent to one of the commissural struts, such that the inflow portion of the externally formed information indicator is axially distal to the outflow edge of the commissural window.

[0228] Example 27. A prosthetic valve according to any example herein, in particular Example 26, wherein the axial distance between the inflow portion of the externally formed information indicator and the outflow edge of the commissure window is less than the difference between the axial height of the prosthetic valve in the radially compressed state and the axial height of the prosthetic valve in the radially expanded state.

[0229] Example 28. A prosthetic valve according to any example herein, in particular any one of examples 1 to 27, wherein the at least one externally formed information indicator is made of a radiopaque material.

[0230] Example 29. The prosthetic valve according to any example herein, in particular any one of examples 1 to 28, wherein the at least one externally formed information indicator indicates the manufacturer of the prosthetic valve.

[0231] Example 30. A prosthetic valve according to any example herein, in particular any one of examples 1 to 29, wherein the at least one externally formed information indicator indicates a model of the prosthetic valve.

[0232] Example 31. A prosthetic valve according to any example herein, in particular any one of examples 1 to 30, wherein the at least one externally formed information indicator represents a deployed diameter of the prosthetic valve.

[0233] Example 32. A prosthetic valve according to any example herein, in particular any one of Examples 1 to 30, wherein the at least one externally formed information indicator includes a first externally formed information indicator formed along one of the vertical struts and a second externally formed information indicator formed along an adjacent vertical strut, wherein the first externally formed information indicator represents a first digit of the expanded diameter of the prosthetic valve and the second externally formed information indicator represents a second digit of the expanded diameter of the prosthetic valve.

[0234] Example 33. A prosthetic valve, comprising:

[0235] An annular frame, the annular frame being movable between a compressed diameter in a radially compressed state and an expanded diameter in a radially expanded state, the frame comprising:

[0236] a plurality of actuation posts, the plurality of actuation posts comprising an upper post member and a lower post member;

[0237] a plurality of support columns, wherein each support column extends between a column inflow end and an opposite column outflow end, and wherein the plurality of support columns comprises:

[0238] a plurality of commissure support posts, wherein each commissure support post comprises a commissure window; and

[0239] a plurality of non-commissural support posts, wherein each non-commissural support post is devoid of a commissural window;

[0240] a plurality of curved struts extending circumferentially between and interconnecting adjacent actuation and support struts;

[0241] a plurality of actuators coupled to the actuation post, the actuators configured to adjust the frame between the radially compressed state and the radially expanded state; and

[0242] at least one information indicator formed in or along at least one of the support columns; and

[0243] a valve structure mounted within the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve;

[0244] wherein two of the curved struts intersect each column inflow end, and another two of the curved struts intersect each vertical strut outflow end; and

[0245] Each support post intersects at least eight curved struts extending from an adjacent actuation post.

[0246] Example 34. The prosthetic valve according to any example herein, in particular Example 33, wherein the information indicator is an internally formed information indicator.

[0247] Example 35. A prosthetic valve according to any example herein, in particular Example 34, wherein the width of each of the support posts is greater than the width of any of the curved struts.

[0248] Example 36. A prosthetic valve according to any example herein, particularly examples 34 or 35, wherein the width of the support post is greater than the width of the internally formed information indicator formed therein.

[0249] Example 37. The prosthetic valve of any example herein, particularly any one of Examples 34 to 36, wherein the at least one internally formed information indicator is formed in at least one of the non-commissural support posts.

[0250] Example 38. A prosthetic valve according to any example herein, in particular any one of Examples 34 to 37, wherein the at least one internally formed information indicator comprises at least two internally formed information indicators, both of the at least two internally formed information indicators being formed at different axial positions of at least one of the non-combined support columns.

[0251] Example 39. The prosthetic valve according to any example herein, in particular Example 38, wherein at least two of the internally formed information indicators are formed differently.

[0252] Example 40. A prosthetic valve according to any example herein, in particular any one of Examples 34 to 37, wherein the at least one internally formed information indicator comprises a plurality of internally formed information indicators formed in a plurality of non-commissural support posts.

[0253] Example 41. A prosthetic valve according to any example herein, in particular Example 40, wherein at least two of the plurality of internally formed information indicators are formed differently.

[0254] Example 42. A prosthetic valve according to any example herein, in particular any one of Examples 34 to 36, wherein the at least one internally formed information indicator is formed in at least one of the commissure support posts.

[0255] Example 43. The prosthetic valve of any example herein, in particular Example 42, wherein the at least one internally formed information indicator is distal to the commissure support posts.

[0256] Example 44. A prosthetic valve according to any example herein, in particular Example 42 or 43, wherein the at least one internally formed information indicator includes at least two internally formed information indicators, both of which are formed at different axial positions of at least one of the commissural support columns.

[0257] Example 45. The prosthetic valve of any example herein, in particular Example 42, wherein at least two of the internally formed information indicators are formed differently.

[0258] Example 46. A prosthetic valve according to any example herein, in particular any one of Examples 42 to 45, wherein the at least one internally formed information indicator comprises a plurality of internally formed information indicators formed in a plurality of commissural support posts.

[0259] Example 47. The prosthetic valve of any example herein, in particular Example 46, wherein at least two of the plurality of internally formed information indicators are formed differently.

[0260] Example 48. The prosthetic valve of any example herein, in particular Example 33, wherein the information indicator is an externally formed information indicator.

[0261] Example 49. The prosthetic valve of any example herein, particularly Example 48, wherein the width of the externally formed information indicator is greater than the width of the support post along which the externally formed information indicator is formed.

[0262] Example 50. A prosthetic valve according to any example herein, in particular examples 48 or 49, wherein the width of each of the support posts is greater than the width of any of the curved struts.

[0263] Example 51. A prosthetic valve according to any example herein, particularly any of Examples 48 to 50, wherein the externally formed information indicator extends from the post inflow end of at least one of the commissure support posts.

[0264] Example 52. A prosthetic valve according to any example herein, particularly any one of Examples 48 to 50, wherein the externally formed information indicator extends from a post outflow end of at least one of the commissure support posts.

[0265] Example 53. A prosthetic valve according to any example herein, in particular any one of Examples 48 to 50, wherein the at least one externally formed information indicator comprises at least two externally formed information indicators, one of which extends from the column inflow end of at least one of the commissural support columns and the other of which extends from the column outflow end of the same commissural support column.

[0266] Example 54. A prosthetic valve according to any example herein, in particular any one of Examples 51 to 53, wherein the at least one externally formed information indicator comprises a plurality of externally formed information indicators formed along a plurality of commissural support posts.

[0267] Example 55. The prosthetic valve of any example herein, particularly any of Examples 48 to 54, wherein the externally formed information indicator extends from a post inflow end of at least one of the non-commissural support posts.

[0268] Example 56. The prosthetic valve of any example herein, particularly any of Examples 48 to 54, wherein the externally formed information indicator extends from a post outflow end of at least one of the non-commissural support posts.

[0269] Example 57. A prosthetic valve according to any example herein, in particular any one of Examples 48 to 54, wherein the at least one externally formed information indicator comprises at least two externally formed information indicators, one of which extends from the column inflow end of at least one of the non-commissural support columns and the other of which extends from the column outflow end of the same non-commissural support column.

[0270] Example 58. A prosthetic valve according to any example herein, in particular any one of Examples 55 to 57, wherein the at least one externally formed information indicator comprises a plurality of externally formed information indicators formed along a plurality of non-commissural support struts.

[0271] Example 59. A prosthetic valve according to any example herein, in particular any one of Examples 49 to 58, wherein the at least one externally formed information indicator comprises a plurality of externally formed information indicators, at least two of the plurality of externally formed information indicators having shapes different from each other.

[0272] Example 60. A prosthetic valve according to any example herein, in particular examples 48 or 59, wherein at least one of the externally formed information indicators is in the shape of a letter, and wherein another of the externally formed information indicators is in the shape of a digit.

[0273] Example 61. A prosthetic valve according to any example herein, in particular any one of Examples 49 to 60, wherein the at least one externally formed information indicator includes an inflow portion connected to two of the curved struts, an opposite outflow portion, and a central portion disposed between the inflow portion and the outflow portion, wherein the central portion includes a transverse body extending in a transverse direction and terminating at a bidirectional vertical extension portion, forming two shoulders at a transition portion between the transverse body and the bidirectional vertical extension portion.

[0274] Example 62. A prosthetic valve according to any example herein, in particular any one of Examples 49 to 61, wherein the at least one externally formed information indicator is made of a radiopaque material.

[0275] Example 63. A prosthetic valve according to any example herein, in particular any one of examples 49 to 62, wherein the at least one externally formed information indicator indicates a manufacturer of the prosthetic valve.

[0276] Example 64. A prosthetic valve according to any example herein, in particular any one of Examples 49 to 63, wherein the at least one externally formed information indicator indicates a model of the prosthetic valve.

[0277] Example 65. A prosthetic valve according to any example herein, in particular any one of examples 49 to 64, wherein the at least one externally formed information indicator represents a deployed diameter of the prosthetic valve.

[0278] Example 66. A prosthetic valve according to any example herein, in particular any one of Examples 33 to 65, wherein the at least one information indicator includes a first information indicator in one of the support columns and a second information indicator in an adjacent support column, wherein the first information indicator represents a first digit of the expanded diameter of the prosthetic valve and the second information indicator represents a second digit of the expanded diameter of the prosthetic valve.

[0279] It should be understood that, for the sake of clarity, certain features of the present invention described in the context of separate examples may also be provided in combination in a single example. Conversely, for the sake of brevity, various features of the present disclosure described in the context of a single example may also be provided separately, or in any suitable sub-combination, or appropriately provided in any other described example of the present disclosure. Unless explicitly stated, features described in the context of an example are not considered essential features of that example.

[0280] In view of the many possible examples to which the principles of the present disclosure may be applied, it should be recognized that the examples shown are merely preferred examples and should not be considered as limiting the scope. Instead, the scope is defined by the following claims. Therefore, we claim protection for all that is within the scope and spirit of these claims.

Claims

1. A prosthetic valve, comprising: An annular frame, the annular frame being movable between a compressed diameter in a radially compressed state and an expanded diameter in a radially expanded state, the frame comprising: a plurality of intersecting angled struts and a plurality of vertical struts, wherein each vertical strut extends between a vertical strut inflow end and an opposing vertical strut outflow end, and wherein the plurality of vertical struts comprises: a plurality of commissure posts, each commissure post comprising a commissure window; and a plurality of non-commissural vertical struts, wherein each non-commissural vertical strut is devoid of a commissural window; at least one externally formed information indicator formed along at least one of said vertical struts; and a valve structure mounted within the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve; wherein two of the angled struts intersect each vertical strut inflow end and another two of the angled struts intersect each vertical strut outflow end; and Wherein the width of said externally formed information indicator is at least as great as the width of said vertical strut along which said externally formed information indicator is formed.

2. The prosthetic valve of claim 1, wherein the externally formed information indicator extends from the vertical strut inflow end of at least one of the commissure struts.

3. The prosthetic valve of claim 1, wherein the externally formed information indicator extends from the vertical strut outflow end of at least one of the commissure struts.

4. A prosthetic valve according to claim 1, wherein the at least one externally formed information indicator includes at least two externally formed information indicators, one of the at least two externally formed information indicators extends from the vertical strut inflow end of at least one of the commissural struts, and the other of the at least two externally formed information indicators extends from the vertical strut outflow end of the same commissural strut.

5. The prosthetic valve of any one of claims 1 to 4, wherein the width of the externally formed information indicator is greater than the width of the vertical strut along which the externally formed information indicator is formed.

6. The prosthetic valve of any one of claims 1 to 5, wherein the at least one externally formed information indicator comprises a plurality of externally formed information indicators, at least two of the plurality of externally formed information indicators being of different shapes from one another.

7. The prosthetic valve of claim 6, wherein at least one of the externally formed information indicators is in the shape of a letter, and wherein another one of the externally formed information indicators is in the shape of a digit.

8. A prosthetic valve according to any one of claims 1 to 7, wherein the frame further comprises at least two support struts extending between at least two adjacent vertical struts and intersecting each other at a support vertex, and wherein at least one support strut extends from at least one externally formed information indicator.

9. A prosthetic valve according to claim 8, wherein the at least one externally formed information indicator includes an inflow portion coinciding with the inflow end of the vertical strut, an opposite outflow portion, and a central portion disposed between the inflow portion and the outflow portion, wherein the central portion is in the form of a laterally oriented extension.

10. A prosthetic valve according to any one of claims 1 to 9, wherein the at least one externally formed information indicator includes an inflow portion connected to two of the angled struts, an opposite outflow portion, and a central portion disposed between the inflow portion and the outflow portion, wherein the central portion includes a transverse body extending in a transverse direction and terminating at a bidirectional vertical extension portion, and two shoulders are formed at a transition portion between the transverse body and the bidirectional vertical extension portion.

11. A prosthetic valve according to any one of claims 1 to 10, wherein the at least one externally formed information indicator extends from the vertical strut outflow end of one of the non-commissural vertical struts adjacent to one of the commissural struts, such that the inflow portion of the externally formed information indicator is axially distal to the outflow edge of the commissural window.

12. A prosthetic valve according to claim 11, wherein the axial distance between the inflow portion of the externally formed information indicator and the outflow edge of the commissure window is less than the difference between the axial height of the prosthetic valve in the radially compressed state and the axial height of the prosthetic valve in the radially expanded state.

13. A prosthetic valve according to any one of claims 1 to 12, wherein the at least one externally formed information indicator includes a first externally formed information indicator formed along one of the vertical struts and a second externally formed information indicator formed along an adjacent vertical strut, wherein the first externally formed information indicator represents a first digit of the expanded diameter of the prosthetic valve and the second externally formed information indicator represents a second digit of the expanded diameter of the prosthetic valve.

14. A prosthetic valve, comprising: An annular frame, the annular frame being movable between a compressed diameter in a radially compressed state and an expanded diameter in a radially expanded state, the frame comprising: a plurality of actuation posts, the plurality of actuation posts comprising an upper post member and a lower post member; a plurality of support columns, wherein each support column extends between a column inflow end and an opposite column outflow end, and wherein the plurality of support columns comprises: a plurality of commissure support posts, wherein each commissure support post comprises a commissure window; and a plurality of non-commissural support posts, wherein each non-commissural support post is devoid of a commissural window; a plurality of curved struts extending circumferentially between and interconnecting adjacent actuation and support struts; a plurality of actuators coupled to the actuation post, the actuators configured to adjust the frame between the radially compressed state and the radially expanded state; and at least one information indicator formed in or along at least one of the support columns; and a valve structure mounted within the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve; wherein two of the curved struts intersect each column inflow end, and another two of the curved struts intersect each column outflow end; and Each support post intersects at least eight curved struts extending from an adjacent actuation post.

15. The prosthetic valve of claim 14, wherein the information indicator is an internally formed information indicator.

16. The prosthetic valve of claim 15, wherein the support post has a width greater than a width of the internally formed information indicator formed therein.

17. A prosthetic valve according to any one of claims 14 to 16, wherein the at least one internally formed information indicator includes at least two internally formed information indicators, both of which are formed at different axial positions of at least one of the non-commissural support columns.

18. The prosthetic valve of claim 14, wherein the information indicator is an externally formed information indicator.

19. The prosthetic valve of claim 18, wherein the width of the externally formed information indicator is greater than the width of the support strut along which the externally formed information indicator is formed.

20. A prosthetic valve according to any one of claims 14 to 19, wherein the at least one information indicator includes a first information indicator in one of the support columns and a second information indicator in an adjacent support column, wherein the first information indicator represents a first digit of the expanded diameter of the prosthetic valve and the second information indicator represents a second digit of the expanded diameter of the prosthetic valve.

Images