Artificial valve with information indicator

Abstract

The present disclosure relates to an artificial valve that includes an information indicator that can indicate appropriate information related to a previously implanted artificial valve. Such an information indicator may be formed internally within a relatively wide support post of a mechanically expandable artificial valve, or may be formed externally along a support post of a mechanically expandable artificial valve or a vertical strut of a balloon-expandable artificial valve.

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This application claims the benefit of U.S. Provisional Patent Application No. 63 / 354,812, filed on June 23, 2022, which is incorporated herein by reference.

[0002] This disclosure relates to an artificial valve that includes an information indicator that can indicate appropriate information related to a previously implanted artificial valve.

Background Art

[0003] Natural heart valves, such as the aortic valve, pulmonary valve, and mitral valve, function to ensure proper direction of flow from the heart to the heart and between the atria and ventricles in order to supply blood to the entire cardiovascular system. Various valvular diseases can cause the valve to malfunction and may require replacement with an artificial valve. Surgical procedures can be performed to repair or replace the heart valve. Surgical procedures are prone to a number of clinical complications, and therefore, alternative minimally invasive techniques for delivering an artificial valve on a catheter and implanting it over a natural malfunctioning valve have been developed over the years.

[0004] Various types of artificial valves, including balloon - expandable valves, self - expandable valves, and mechanically expandable valves, have been previously known. Various methods for delivery and implantation are also known and can vary depending on the implantation site and the type of artificial valve. As one exemplary technique, the use of a delivery assembly for delivering an artificial valve in a crimped state from an incision that can be positioned in a patient's femoral artery or iliac artery towards the natural malfunctioning valve can be mentioned. Once the artificial valve is properly positioned at the desired implantation site, the artificial valve can expand against the surrounding anatomical structures, such as the annulus of the natural valve, and then the delivery assembly can be retrieved.

[0005] After a patient has already had a previous prosthetic valve implanted, there may be a need for reintervention. In such cases, the clinician needs to know the specific characteristics of the previously implanted prosthetic valve in order to determine the most appropriate course of action. Thus, there is a need to convey such characteristics, for example, related to the manufacturer, type, model, valve size, or any other characteristics of the valve initially implanted, which can guide the clinician in selecting an appropriate type of treatment such as an appropriate replacement prosthetic valve. Summary of the Invention Means for Solving the Problems

[0006] The present disclosure is directed to prosthetic valves that include an information indicator that can indicate appropriate information related to a previously implanted prosthetic valve. Such an information indicator may be formed internally within 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 strut of a balloon-expandable prosthetic valve.

[0007] According to one aspect of the present disclosure, a prosthetic valve includes an annular frame movable between a compressed diameter in a radially compressed state and a deployed diameter in a radially expanded state, and a valve structure provided within the frame and including a plurality of valve leaflets configured to regulate flow through the prosthetic valve. The frame includes 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.

[0008] In some aspects, each of the plurality of vertical struts extends between a vertical strut inflow end opposite a vertical strut outflow end.

[0009] In some aspects, the plurality of vertical struts includes a plurality of interconnected struts, each interconnected strut including an interconnect window and a plurality of non-interconnected vertical struts, each non-interconnected vertical strut lacking an interconnect window.

[0010] In some embodiments, two of the angled struts intersect each vertical strut inlet end, and another two of the angled struts intersect each vertical strut outlet end.

[0011] In some embodiments, the width of the externally formed information indicator is at least as large as the width of the vertical strut along which it is formed.

[0012] In some embodiments, the externally formed information indicator extends from at least one vertical strut inlet end of the cross-linked struts.

[0013] In some embodiments, the externally formed information indicator extends from at least one vertical strut outlet end of the cross-linked struts.

[0014] In some embodiments, at least one externally formed information indicator includes at least two externally formed information indicators, one of which extends from at least one vertical strut inlet end of the cross-linked struts and the other of which extends from the vertical strut outlet end of the same cross-linked strut.

[0015] In some embodiments, the width of the externally formed information indicator is greater than the width of the vertical strut along which it is formed.

[0016] In some embodiments, at least one externally formed information indicator includes a plurality of externally formed information indicators, at least two of which have different shapes from each other.

[0017] In some embodiments, at least one of the externally formed information indicators is in the shape of a character and the other of the externally formed information indicators is in the shape of an Arabic numeral.

[0018] In some embodiments, the frame further comprises at least two support struts that extend between at least two adjacent vertical struts and intersect each other at a support apex, and at least one support strut extends from at least one externally formed information indicator.

[0019] In some embodiments, at least one externally formed information indicator comprises an inflow portion that coincides with the vertical strut inflow end, an outflow portion on the opposite side, and a central portion disposed therebetween, and the central portion is in the form of a laterally oriented extension.

[0020] In some embodiments, at least one externally formed information indicator comprises an inflow portion connected to two of the angled struts, an outflow portion on the opposite side, and a central portion disposed therebetween, and the central portion comprises a lateral body that extends laterally and terminates in a bidirectional vertical extension, and two shoulders are formed at the transition between the lateral body and the bidirectional vertical extension.

[0021] In some embodiments, at least one externally formed information indicator extends from the vertical strut outflow end of one of the non-interconnecting vertical struts adjacent to one of the interconnecting struts such that the inflow portion of the externally formed information indicator is axially distal to the outflow edge of the interconnecting window.

[0022] In some embodiments, the axial distance between the inflow portion of the externally formed information indicator and the outflow edge of the interconnecting 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.

[0023] In some embodiments, 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, the first externally formed information indicator indicating the first digit of the deployed diameter of the prosthetic valve and the second externally formed information indicator indicating the second digit of the deployed diameter of the prosthetic valve.

[0024] According to one aspect of the present disclosure, an artificial valve includes an annular frame movable between a compressed diameter in a radially compressed state and a deployed diameter in a radially expanded state, and a valve structure provided within the frame and including a plurality of valve tips configured to regulate the flow through the artificial valve. The frame includes a plurality of actuating posts including an upper post member and a lower post member, a plurality of support posts, and a plurality of actuators coupled to the actuating posts and configured to adjust the frame between a radially compressed state and a radially expanded state, and at least one information indicator.

[0025] In some aspects, each support post extends between a post inflow end opposite the post outflow end.

[0026] In some aspects, at least one information indicator is formed within or along at least one of the support posts.

[0027] In some aspects, the plurality of support posts includes a plurality of interconnected support posts, each interconnected support post including an interconnect window and a plurality of non-interconnected support posts, each non-interconnected support post lacking an interconnect window.

[0028] In some aspects, a plurality of curved struts extend circumferentially between adjacent actuating posts and support posts to interconnect the actuating posts and the support posts.

[0029] In some aspects, two of the curved struts intersect each post inflow end, and two other of the curved struts intersect each post outflow end.

[0030] In some aspects, each support post intersects at least eight curved struts extending from adjacent actuating posts.

[0031] In some aspects, the information indicator is an information indicator formed internally.

[0032] In some embodiments, the width of the support post is greater than the width of the information indicator formed therein within the interior formed therein.

[0033] In some embodiments, at least one information indicator formed within the interior includes at least two information indicators formed within the interior, both of which are formed at at least one different axial position of the non-intersecting support posts.

[0034] In some embodiments, the information indicator is an information indicator formed externally.

[0035] In some embodiments, the width of the information indicator formed externally is greater than the width of the support post along which it is formed.

[0036] In some embodiments, at least one information indicator includes a first information indicator in one of the support posts and a second information indicator in an adjacent support post, the first information indicator indicating the first digit of the deployed diameter of the prosthetic valve and the second information indicator indicating the second digit of the deployed diameter of the prosthetic valve.

[0037] According to some embodiments of the present disclosure, a prosthetic valve is provided that includes an annular frame movable between a radially compressed state and a radially expanded state. The frame includes a plurality of intersecting angled struts and a plurality of vertical struts, each extending between a vertical strut inflow end and a vertical strut outflow end opposite thereto. Two of the angled struts intersect each vertical strut inflow end, and two other of the angled struts intersect each vertical strut outflow end. The frame further includes at least one information indicator formed within or along at least one of the vertical struts.

[0038] According to some aspects of the present disclosure, an artificial valve is provided that includes an annular frame and a valve structure mounted within the frame. The frame is movable between a compressed diameter in a radially compressed state and a deployed diameter in a radially expanded state. The frame includes a plurality of intersecting angled struts and a plurality of vertical struts, each vertical strut extending between a vertical strut inlet end opposite the vertical strut outlet end. The plurality of vertical struts includes a plurality of interconnected struts and a plurality of non-interconnected vertical struts. Each interconnected strut includes an interconnect window. Each non-interconnected vertical strut lacks an interconnect 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 valve leaflets configured to regulate flow through the artificial valve. Two of the angled struts intersect each vertical strut inlet end, and two other of the angled struts intersect each vertical strut outlet end. The width of the externally formed information indicator is at least as large as the width of the vertical strut along which it is formed.

[0039] According to some aspects of the present disclosure, an artificial valve is provided that includes an annular frame and a valve structure installed within the frame. The frame is movable between a compressed diameter in a radially compressed state and a deployed diameter in a radially expanded state. The frame includes a plurality of actuation posts, a plurality of support posts, a plurality of curved struts, a plurality of actuators coupled to the actuation 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 opposite the post outflow end. The plurality of support posts includes a plurality of interconnected support posts and a plurality of non-interconnected support posts. Each interconnected support post includes an interconnect window. Each non-interconnected support post lacks an interconnect window. The curved struts extend circumferentially between adjacent actuation posts and support posts, interconnecting the actuation posts and support posts. The actuators are configured to adjust the frame between a radially compressed state and a radially expanded state. Two of the curved struts intersect each post inflow end, and two other of the curved struts intersect each vertical strut outflow end. Each support post intersects at least eight curved struts extending from adjacent actuation posts.

[0040] The various aspects of the present disclosure can be used in combination or individually. This summary is provided to introduce, in a simplified form, a selected one of the various concepts described in the detailed description below. The summary of the invention is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying drawings.

[0041] In this specification, several embodiments of the present invention will be described with reference to the accompanying drawings. This specification, together with the drawings, makes it clear to those skilled in the art how the several embodiments can be implemented. The drawings are for illustrative purposes only and are not intended to show structural details of the embodiments in more detail than is necessary for a basic understanding of the present invention. For clarity purposes, some of the objects shown in the drawings are not to scale.

[0042] In the drawings, it is as follows.

Brief Description of the Drawings

[0043]

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[0044] For the purposes of this specification, specific aspects, advantages, and novel features in the examples of this disclosure are described herein. The disclosed methods, apparatuses, and systems should not be construed as being limited in any way. Instead, this disclosure is directed to all novel and non-obvious features and aspects related to the various disclosed examples, alone, in various combinations with each other, and in various sub-combinations with each other. The methods, apparatuses, and systems are not limited to any particular aspect, feature, or combination thereof, and the disclosed examples do not require the presence of any one or more particular advantages, nor do they require problems to be solved. The techniques from any example can be combined with the techniques described in any one or more of the other examples. Considering the many possible examples to which the principles of the disclosed techniques can be applied, it will be recognized that the illustrated examples are merely preferred examples and should not be regarded as limiting the scope of the disclosed techniques.

[0045] In some of the disclosed examples, the operations are described in a particular sequential order for presentation convenience. However, it should be understood that this mode of description encompasses permutations, unless a particular order is required by the specific language described below. For example, the operations described sequentially may, in some cases, be permuted or may be executed simultaneously. Additionally, for simplicity, the accompanying drawings may not show various ways in which the disclosed method can be used in combination with other methods. Additionally, in the description, terms such as "provide" or "achieve" may be used to describe the disclosed method. These terms are high-level abstractions regarding the actual operations to be performed. The actual operations corresponding to these terms may vary depending on the specific implementation and are readily recognizable by those skilled in the art.

[0046] All features described in this specification are independent of each other and, except where structurally impossible, can be used in combination with any other feature described in this specification.

[0047] As used in this application and the claims, the singular forms "a", "an", and "the" include the plural unless the context clearly dictates otherwise. Additionally, the term "have" or "includes" means "comprises". Further, the terms "coupled", "connected", or "attached", as used in this specification, are interchangeable and generally mean being coupled or connected physically, mechanically, chemically, magnetically, and / or electrically, and do not exclude the presence of intermediate elements between the coupled or associated members unless a specific contrary language is provided. As used in this specification, "and / or" means "and" or "or", and also means both "and" and "or".

[0048] In this specification, for the purpose of facilitating the description of the drawings and principles, directional and other relative references may be used, but these are not intended to be limiting. For example, specific terms such as "inner", "outer", "upper", "lower", "inside", "outside", "top", "bottom", "in", "out", "left", "right", and the like may be used. Such terms, if appropriate, are used to provide a certain degree of clarity in the description when dealing with relative relationships, particularly with respect to the specifically illustrated examples. However, such terms are not intended to imply absolute relationships, positions, or directions. For example, for an object, simply by turning it over, the "upper" part may become the "lower" part. Nevertheless, it remains the same part, and the object remains the same.

[0049] The terms "plurality" or "a plurality of", when used in conjunction with an element, mean two or more elements. Directional and other relative references (e.g., inner and outer, upper and lower, above and below, left and right, and proximal and distal) may be used to facilitate the discussion of the drawings and principles in this specification, but are not intended to be limiting.

[0050] The terms "proximal" and "distal" are defined with respect to the location of use of the delivery device. Generally, 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 (e.g., the end inserted into the patient's body) is the distal end. When used in connection with two spatially separated positions or parts of an object, the term "proximal" can be understood to mean closer to, or oriented toward, the proximal end of the delivery device. When used in connection with two spatially separated positions or parts of an object, the term "distal" can be understood to mean closer to, or oriented toward, the distal end of the delivery device. The terms "longitudinal" and "axial" are interchangeable and, unless otherwise explicitly defined, refer to an axis extending in the proximal and distal directions.

[0051] Of course, the disclosed embodiments can be adapted to deliver and implant an artificial device within any of the native valve annuli of the heart (e.g., the pulmonary valve annulus, the mitral valve annulus, and the tricuspid valve annulus) and can be used with any of a variety of delivery approaches (e.g., aortic, retrograde, antegrade, transseptal, transventricular, transatrial, etc.).

[0052] To avoid unnecessary clutter due to having an excessive number of reference numerals and leader lines on a particular drawing, some components are introduced via one or more drawings and are not explicitly identified in any subsequent drawings that include such components.

[0053] FIG. 1 shows an artificial valve 100 according to one embodiment. The artificial valve 100 may be configured to replace a native heart valve (e.g., aortic valve, mitral valve, pulmonary valve, and / or tricuspid valve). The artificial valve 100 is shown as a mechanically expandable artificial valve that can be radially compressed for delivery to a implantation location within a patient's body and then radially expanded to an operating diameter at the implantation location. The artificial valve 100 can include a frame 104 having an annular shape. The artificial valve 100 can further include a valve structure 108 coupled to and supported within the frame 104.

[0054] In an example, the valve structure 108 includes one or more valve leaflets 112 made of a flexible material and configured to open and close to regulate blood flow. In one example, the valve structure 108 may have three valve leaflets 112, which may be arranged to be folded in a tricuspid configuration. The valve leaflets 112 may be made entirely or partially of pericardial tissue (e.g., bovine pericardial tissue), a biocompatible synthetic material, or various other suitable natural or synthetic materials.

[0055] As shown, the frame 104 has an inlet end 116, an outlet end 120, and a central longitudinal axis C extending in a direction from the inlet end 116 to the outlet end 120. The frame 104 may include a plurality of support posts 124 and actuator posts 128 that are aligned with the central longitudinal axis L and spaced apart along the perimeter of the frame 104. In one embodiment, the support posts 124 and actuator posts 128 may be alternately disposed along the perimeter of the frame 104. The frame 104 may further include a plurality of struts 132 that extend circumferentially between adjacent support posts 124 and actuator posts 128 and interconnect the support posts 124 and actuator posts 128. The struts 132, support posts 124, and actuator posts 128 define cells 136 of the frame 104. As shown, the struts 132 may have an inclined or curved shape.

[0056] One or more communication windows 140 may be formed in one or more of the support posts 124 (the communication windows 140 are hidden in FIG. 1 but are similar to the exposed communication windows 240 in FIG. 2). A junction 144 may be formed in the communication window 140 to couple the valve tip 112 to the frame 104. The support posts 124 may include communication support posts 125 that are the support posts 124 including the communication windows 140 and non-communication support posts 126 that are the support posts 124 lacking the communication windows. The communication support posts 125 and non-communication support posts 126 may be alternately disposed along the perimeter of the frame 104. In the illustrated embodiment, the frame 104 includes a total of six support posts 124, three of which are communication support posts 125 and three of which are non-communication support posts 126.

[0057] One or more of the support posts 124 may further include a cantilever strut 134 that extends to the inlet end 116 of the frame 104. In some embodiments, the cantilever strut 134 may extend such that the distal end of the cantilever strut 134 is aligned or substantially aligned with the inlet end 116 of the frame 104.

[0058] The prosthetic valve 100 can further include one or more skirts or sealing members. For example, the prosthetic valve 100 can include an inner skirt (not shown in FIG. 1) mounted on the radially inner surface of the frame 104. The inner skirt can function as a sealing member to prevent or reduce perivalvular leakage, can anchor the valve tip 112 to the frame 104, and / or can protect the valve tip 112 from damage caused by contact with the frame 104 during compression or the operating cycle of the prosthetic valve 100. The prosthetic valve 100 can further include an outer skirt (not shown in FIG. 1 but generally similar to the outer skirt 924 shown in FIG. 10 for a different valve type) mounted on the outer surface of the frame 104. The outer skirt can function as a sealing member for the prosthetic valve 100 by sealing against the tissue of the native valve annulus and assisting in reducing perivalvular leakage through the prosthetic valve 100. The inner skirt and the outer skirt can be formed from any of a variety of suitable biocompatible materials, including any of a variety of synthetic materials (e.g., polyethylene terephthalate fabric) or autologous tissue (e.g., pericardial tissue). Further details regarding the use of skirts or sealing members in prosthetic valves can be found, for example, in U.S. Patent Application No. 62 / 854,702 and PCT Patent Application No. US2020 / 024559, each of which is incorporated herein by reference.

[0059] In some cases, as shown in the embodiment illustrated in FIG. 1, the inlet edge portion of the valve tip 112 can be attached to the cantilever strut 134 and / or a selected strut 132 of the frame 104. Alternatively or additionally, the cantilever strut 134 can prevent or mitigate a portion of the outer skirt from extending radially inward, thereby preventing or mitigating an obstruction to the flow through the inlet end 116 of the frame 104 caused by the outer skirt. The cantilever strut 134 can further function as a support to which a portion of the inner and / or outer skirt can be coupled. For example, the suture used to connect the inner and / or outer skirt may be wound around the cantilever strut 134 and / or extend through an opening formed in the end portion of the cantilever strut 134.

[0060] In some implementations, the valve tip 112 can be directly sutured to the strut 132 of the frame 104. In other implementations, the proximal edge portion of the valve tip can generally be sutured to the inner skirt along a scallop line. The inner skirt can then be sutured to an adjacent strut 132 of the frame 104, for example, via one or more sutures.

[0061] Each support post 124, including any cross-linked support post 125 or non-cross-linked support post 126, extends between a post inlet end 180 near the inlet end 116 of the valve 100 and a post outlet end 182 near the outlet end 120 of the valve 100. Two curved struts 132 intersect each support post 124 at a post inlet end 180 that is circumferentially disposed between two adjacent inlet tips 114 such that the corresponding cantilever strut 134 can extend distally from the post inlet end 180. Similarly, two curved struts 132 intersect each support post 124 at a post outlet end 182 that is circumferentially disposed between two adjacent outlet tips 118.

[0062] As further shown, each cross-linked support post 125 and each non-cross-linked support post 126 also intersect at their intermediate portions, resulting in two or four additional curved struts 132 extending from adjacent upper post members 160 and lower post members 164 on both sides, and each support post 124, particularly each cross-linked support post 125 and each non-cross-linked support post 126, intersecting with a total of at least eight curved struts extending from adjacent actuating posts 128.

[0063] 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., posts and struts) can be made of a biocompatible plastically expandable material that allows the frame 104 to be adjusted between a radially expanded configuration and a radially compressed configuration. Suitable examples of plastically 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 (also referred to as "NiTi" or "nitinol").

[0064] In some embodiments, one or more actuators 170 can be coupled to the actuating posts 128 and used to adjust the frame 104 between a radially expanded configuration and a radially compressed configuration. In one embodiment, each actuating post 128 can include upper post member 160 and lower post member 164 (the terms upper and lower are relative to the orientation of the artificial valve 100 in FIG. 1) having opposing ends aligned with the longitudinal axis C and separated by a gap. Each actuator 170 can be coupled to the post members 160, 164 and be operable to increase or decrease the gap therebetween to radially compress or expand the frame 104. The struts 132 can come together with the upper post member 160 to define an outflow tip 118 at the outflow end 120. The struts 132 can similarly come together with the lower post member 164 to define an inflow tip 114 at the inflow end 116.

[0065] In one embodiment, the actuator 170 may include an actuator rod 172 having an attached actuator head. In the embodiment illustrated in FIG. 1, the actuator rod 172 extends through the post members 160, 164 or into and across the gap between the post members 160, 164. In the embodiment illustrated in FIG. 1, the actuator rod 172 is inserted into the upper post member 160 from the outflow end 120, and the actuator head (hidden from view in FIG. 1) may be disposed or held at the outflow tip of the upper post member 160.

[0066] In some embodiments, the actuator rod 172 has external threads. As shown in FIG. 1, the lower post member 164 may include a nut 176 having internal threads for threaded engagement with the actuator rod 172. In this case, the actuator rod 172 may be axially translated by rotating the actuator rod 172 relative to the nut 176. In some embodiments, the actuator rod 172 may be freely slidable relative to the upper post member 160. In other embodiments, the actuator rod 172 may be capable of threaded engagement with the upper post member 160. As used herein, the term "axially translated" refers to translation along an axis that coincides with or is parallel to the central longitudinal axis C.

[0067] In one scenario, the actuator rod 172 can be rotated in a first direction to move the upper post member 160 toward the lower post member 164, thereby reducing the size of the gap therebetween, which may have the effect of radially expanding the frame 104. In another scenario, while rotating the actuator rod 172 in a second direction to move the upper post member 160 away from the lower post member 164, thereby increasing the size of the gap therebetween (which may have the effect of radially compressing the frame 104), the lower post member 164 may be stably held.

[0068] The actuator rod 172 can also include a stopper 178 (e.g., in the form of a nut, washer, or flange) disposed thereon. The stopper 178 can be disposed on the actuator rod 172 such that it is located within the gap therebetween. Further, the stopper 178 may be integrally formed on the actuator rod 172 or fixedly coupled to the actuator rod 172 so as not to move relative to the actuator rod 172. Thus, the stopper 178 can remain at a fixed axial position on the actuator rod 172 so as to move in the same direction and at the same speed as the actuator rod 172.

[0069] When the actuator rod 172 rotates in a direction configured to fold the prosthetic valve, the stopper 178 moves toward the outflow end 120 of the frame until it abuts against the inflow end of the upper post member 160. As the actuator rod 172 further rotates, the stopper 178 can apply a proximally-directed force to the upper post member 160 to radially compress the frame 104. Specifically, during the crimping / radial compression of the prosthetic valve 100, the actuator rod 172 can rotate in a direction that causes the stopper 178 to push the inflow end of the upper post member 160 (i.e., provide a proximally-directed force), thereby causing the upper post member 160 to move away from the lower post member 164, whereby the prosthetic valve 100 elongates axially and compresses radially.

[0070] In an alternative implementation, a portion of the actuator rod 172 can rotate in one direction while another actuator rod 172 rotates in the opposite direction simultaneously to either radially expand or radially compress the frame. This reverse rotation of the actuator rods can be used to help reduce the likelihood that the entire frame 104 rotates about the central longitudinal axis C during rotation about the axis of each of the actuator rods 172 (e.g., when radially expanding the frame 104).

[0071] Additional examples of mechanically expandable valves can be found in International Application No. PCT / US2021 / 052745, and U.S. Provisional Patent Applications Nos. 63 / 209904 and 63 / 282463, which are hereby incorporated by reference herein.

[0072] The prosthetic valve disclosed herein includes at least one information indicator formed in or along a support post or a portion of a vertical strut of the frame. Since the frame of the prosthetic valve has conventionally been made of a radiopaque material (e.g., a metallic material), such information indicator boundaries, which are formed from openings passing through the thickness of a component of the frame (such as a support post) or by cutting the outer boundary of a component of the frame (such as a vertical strut) to form the desired shape of the indicator, can be detected using suitable clinical imaging techniques such as fluoroscopy, magnetic resonance imaging (MRI), computed tomography (CT), etc.

[0073] The information indicator can provide a clinician (or any other user) with information regarding one or more of the implanted prosthetic valve, such as the manufacturer, type, model number, valve size, and / or manufacturing date associated with the prosthetic valve. In the event of a need for reintervention, such information can assist the clinician, for example, in determining which replacement prosthetic valve may be compatible with the original prosthetic valve. In another scenario, such information can be important in an emergency situation to help determine whether a patient has an implanted prosthetic valve and, if so, the manufacturer, type, model, etc. of the prosthetic valve. Any information indicator disclosed herein can be in the form of alphanumeric characters, symbols, or any other geometric shape.

[0074] For example, a manufacturer may have multiple models of artificial valves, each of which may have several sizes (e.g., 20mm, 23mm, 26mm, 29mm), which may be extended to a deployed diameter (e.g., for a 23mm valve, 23mm) or a range of diameters (e.g., for a 23mm valve, 21 - 24mm). The information indicator may indicate the implanted valve diameter, for example, by the shape of the last digit of the valve size (e.g., "3" for a 23mm valve). In other embodiments, two adjacent information indicators may be formed as both digits of the valve size (e.g., the information indicators are formed as "2" and "3" for a 23mm valve).

[0075] As shown, the actuating posts 128 are arranged in pairs, each pair including an upper post member 160 and a lower post member 164 that may be axially aligned with each other, and each pair of actuating posts 128 may be connected, for example via struts 132, to the cross - linked support post 125 on one side thereof and to the non - cross - linked support post 126 on the other side. As shown, the support post 124 disposed between the struts 132 may have a circumferential width that is greater than the width of the other curved or angled struts 132 of the frame 104 to improve the structural stability of the frame 104. This unique feature of the increased width can be utilized by adding an information indicator 150 formed from an opening passing through the thickness of one or more support posts 124 and constrained between the outer boundaries of the support posts 124.

[0076] Figure 1 shows a mechanically expandable prosthetic valve 100 having at least one non - contiguous support post 126 that includes an information indicator 150 formed therein. The term "formed therein" as used herein throughout this specification means that the outer boundary of the opening that forms the information indicator is completely constrained within the outer boundary of the support post or vertical strut. More specifically, the outer boundary of the information indicator does not form the circumferential boundary of any part of the support post or vertical strut, but rather is offset away from the circumferential boundary of the support post or vertical strut, leaving a frame material constrained between the circumferential boundary of the information indicator and the circumferential boundary of the support post or vertical strut in which it is formed (as will be further described below with respect to balloon - expandable prosthetic valves), and is formed from an opening or cutout passing through the thickness of the support post or vertical strut. Stated another way, an information indicator formed therein is formed by creating one or more through - openings or voids in the shape of the desired alphanumeric, symbol, or any other geometric shape of the information indicator.

[0077] As shown in FIG. 1, the non - contiguous support post 126 can have a width W1 in the circumferential direction (i.e., between its circumferential boundaries), while the information indicator 150 formed therein can 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 shown in FIG. 1 and described above, the particular frame design described herein has the advantage of including support posts 124, such as non - contiguous support posts 126, that have a width significantly greater than the width of the 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 strut 132), enabling an information indicator formed therein to be formed in such support posts 124 without changing the outer shape or dimensions of the support post 124 or any other component of the prosthetic valve 100 for that purpose.

[0078] The information indicator 150 can be formed at any location along the length of the non-connected support post 126. Although an E-shaped information indicator 150 is illustrated, it should be understood that the information indicator 150 can be in the shape of any other alphanumeric, symbol, or any other geometric shape. Although a single information indicator 150 is shown as being formed on one non-connected support post 126 of FIG. 1, it should be understood that multiple non-connected support posts 126 can include information indicators 150 formed therein, and any non-connected support post 126 can include multiple information indicators 150 formed therein. When multiple information indicators 150 formed therein are included, they can be of the same shape or, for example, of different shapes to convey different information details of the artificial valve 100.

[0079] As described above, the size of the artificial valve, i.e., the deployment diameter, can include two digits. In some implementations, at least one information indicator formed therein indicates the deployment diameter of the artificial valve by taking the shape of the last digit of the deployment diameter of the artificial valve. Since support posts such as the non-connected support posts 126 formed therein may not provide sufficient space to include both digits, in some implementations, two adjacent support posts such as two adjacent non-connected support posts 126 can each include one of the digits of the two-digit deployment diameter, and these can be similar or different from each other. For example, for an artificial valve having a deployment diameter of 23 mm, one information indicator formed in one of the non-connected support posts 126 can take the shape of the first digit (e.g., "2"), while another information indicator formed in another non-connected support post 126 adjacent to the first non-connected support post 126 can take the shape of the second digit (e.g., "3").

[0080] FIG. 2 shows another exemplary artificial valve 200 shown without soft components (such as skirts or valve structures) for clarity. Artificial valve 200 is shown to have at least one cross-linked support post 225 that includes an information indicator 250 formed therein. Except for this, artificial valve 200 is structurally similar to the described artificial valve 100 and can function in a similar manner. For example, artificial valve 200 can include a frame 204 that extends between an inflow end 216 and an outflow end 220. Frame 204 includes a plurality of operating support posts 228 that define a pair of upper post members 260 and lower post members 264, a cross-linked support post 225 with a cross-linked window 240, and support posts 224 that include non-cross-linked support posts 226 lacking a cross-linked window. Frame 204 can also include a plurality of curved or angled struts 232 that extend circumferentially between adjacent support posts 224, 228 and interconnect support posts 224, 228. Struts 232 and support posts 224, 228 define cells 236 of frame 204.

[0081] Each support post 224 that includes any cross-linked support post 225 or non-cross-linked support post 226 extends between a post inflow end 280 and a post outflow end 282. Two curved struts 232 intersect each support post 224 at a post inflow end 280 that is circumferentially disposed between two adjacent inflow tips 214 such that the corresponding cantilever strut 134 can extend distally from the post inflow end 180. Similarly, two curved struts 232 intersect each support post 224 at a post outflow end 282 that is circumferentially disposed between two adjacent outflow tips 218. Other structural and functional components of artificial valve 200 can be similar to those described with respect to artificial valve 100. Similar numbers refer to similar components and are not further described for brevity.

[0082] As shown in FIG. 2, the cross-linked support post 225 can have a width W3 in the circumferential direction, while the information indicator 250 formed therein can have a width W4 in the circumferential direction such that W3 is greater than W4 (W3>W4). The non-cross-linked support post 226 can have a width W1 similar to the non-cross-linked support post 126 described above with respect to the frame 104. For the same reasons described above (i.e., increasing the structural stability of the frame 204), the width W4 of the cross-linked support post 225 may be similar to the width W1 of the non-cross-linked support post 226, or in some implementations, may be greater than the width W1 of the non-cross-linked support post 226 due to the fact that, for example, it is necessary to accommodate the cross-linked window 240 formed therein that does not exist in the non-cross-linked support post 226.

[0083] The information indicator 250 is shown to be distal to the cross-linked window 240 in the illustrated embodiment, but it should be understood that the information indicator 250 formed internally can be formed at any position along the length of the cross-linked support post 225, including proximal to the cross-linked window 240, if the cross-linked window 240 is sufficiently distant from the post outflow end 282 to accommodate such an information indicator 250.

[0084] Although an E-shaped information indicator 250 is shown, it should be understood that the information indicator 250 can be in the shape of any other alphanumeric, symbol, or any other geometric shape. A single information indicator 250 is shown to be formed in each of the three cross-linked support posts 225 illustrated in FIG. 2, but it should be understood that any other number of cross-linked support posts 225 can include an information indicator 250 formed internally, and any cross-linked support post 225 can include a plurality of information indicators 250 formed internally. If a plurality of information indicators 250 formed internally are included, they may be of the same shape or, for example, of different shapes to convey different information details of the artificial valve 200.

[0085] In FIG. 1, it is shown that the prosthetic valve 100 includes at least one information indicator 150 formed internally in at least one non-articulating support post 126, and in FIG. 2, it is shown that the prosthetic valve 200 includes an information indicator 250 formed internally in an articulating support post 225. However, in other implementations, a mechanically expandable prosthetic valve 100 or 200 may include information indicators 150, 250 formed internally in at least one of its at least one non-articulating support posts 126, 226, as well as information indicators 150, 250 formed internally in at least one of its at least one articulating support posts 125, 225. In such implementations, some or all of the plurality of internally formed information indicators 150, 250 may be of similar shape or of different shapes.

[0086] As described above, since support posts 124, 224 such as articulating support posts 125, 225 or non-articulating support posts 126, 126 may not provide sufficient space to contain both digits, in some implementations, two adjacent support posts 124, 224 such as articulating support posts 125, 225 and adjacent non-articulating support posts 126, 226 may each contain one of the digits of a two-digit expanded diameter, which may be similar or different from each other. For example, for a prosthetic valve having an expanded diameter of 23 mm, an information indicator formed internally in one of the articulating support posts 125, 225 may take the shape of the first digit (e.g., "2"), while an information indicator formed internally in another of the non-articulating support posts 126, 226 adjacent to the articulating support posts 125, 225 may take the shape of the second digit (e.g., "3").

[0087] FIG. 4 shows another exemplary artificial valve 400 shown without soft components (such as skirts or valve structures) for clarity. The artificial valve 400 may 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. Except for this, the artificial valve 400 is structurally similar to the described artificial valve 100 and can function in a similar manner. For example, the artificial valve 400 can include a frame 404 that extends between an inflow end 416 and an outflow end 420. The frame 404 includes a plurality of operating support posts 428 that define a pair of upper post members 460 and lower post members 464, and support posts 424 that include a cross-linked support post 425 with a cross-linked window 440 and a non-cross-linked support post 426 without a cross-linked window. The frame 404 can also include a plurality of curved or angled struts 432 that extend circumferentially between adjacent support posts 424, 428 and interconnect the support posts 424, 428. The struts 432 and the support posts 424, 428 define cells 436 of the frame 404.

[0088] Although only one side of the frame 404 is depicted in FIG. 4, it should be understood that the frame 404 forms an annular structure with an opposite side that is substantially identical to the portion shown in FIG. 4. Each support post 424 that includes any cross-linked support post 425 or non-cross-linked support post 426 extends between a post inflow end 480 and a post outflow end 482. Two curved struts 432 intersect each support post 424 at a post inflow end 480 that is circumferentially disposed between two adjacent inflow tips 414 such that a corresponding cantilever strut 434 can extend distally from the post inflow end 480. Similarly, two curved struts 432 intersect each support post 424 at a post outflow end 482 that is circumferentially disposed between two adjacent outflow tips 418. Other structural and functional components of the artificial valve 400 may be similar to those described with respect to the artificial valve 100, and like numbers refer to like components and will not be further described for brevity.

[0089] As described above, the mechanically expandable prosthetic valve 400 has at least one support post 424 that includes an externally formed information indicator 450. As used herein throughout this specification, the term "externally formed" refers to being formed by a cutout along an outer boundary that defines at least a portion of the support post or vertical strut such that the outer boundary that forms the information indicator is continuous with the outer boundary that defines the remainder of the support post or vertical strut. Stated another way, an externally formed information indicator is formed by creating a cutout along the outer boundary such that the solid material defined between these boundaries is in the shape of the desired alphanumeric, symbol, or any other geometric shape of the information indicator. The externally formed information indicator of this specification has a circumferential width that is greater than or equal to the width of the remainder of the support post or vertical strut.

[0090] The externally formed information indicator can be advantageous over an internally formed information indicator when the support post or support strut does not have sufficient (circumferential) width to accommodate the internally formed information indicator, or when the resulting potential internally formed information indicator is relatively small due to the limited width of the support post or vertical strut in which it is formed and is difficult to identify with clinical imaging techniques (e.g., fluoroscopy), because the externally formed information indicator can have a width that is similar to the width of the support post or vertical strut, or greater than the width of the support post or vertical strut, and thus greater than the width of an arbitrarily chosen alternative internally formed information indicator.

[0091] An information indicator formed external to the present specification extends from the post inflow end or the post outflow end of the support post, or from the vertical post inflow end or the vertical post outflow end of the vertical post (to be described in more detail below). The position of the information indicator formed external to the support post or vertical post extending from the inflow end or the outflow end is advantageous over other axial positions along the support post or vertical post, because such inflow ends or outflow ends allow the curved or angled struts of the frame to converge with the support post or vertical post along them, resulting in increased structural stability for the resulting information indicator.

[0092] Frame 404 of FIG. 4 is illustrated as showing two exemplary externally formed information indicators 450, namely, an information indicator 450a extending from the post inflow end 480 of the interconnected support post 424, and an information indicator 450b extending from the post outflow end 482 of the non-interconnected support post 426. As shown, the non-interconnected support post 426 may have a circumferential width W5, while the information indicator 450b formed along it may have a circumferential width W6 such that W6 > W5. The interconnected support post 425 may have a circumferential width W7, while the information indicator 450a formed along it may have a circumferential width W8 such that W8 > W7. The width W7 of the interconnected support post 425 may be similar to the width W5 of the non-interconnected support post 426, or in some implementations may be greater than the width W5 of the non-interconnected support post 426, for example, due to the fact that it needs to accommodate an interconnected window 440 formed therein that is not present in the non-interconnected support post 426.

[0093] The information indicator 450a is shown to extend distally from the post inflow end 480 of the crosslink support post 425 of the crosslink window 440 of the illustrated embodiment. However, if the crosslink window 440 is sufficiently spaced from the post outflow end 482 to accommodate such an information indicator 450, it should be understood that an externally formed information indicator 450 may similarly extend proximally from the post outflow end 482 of the crosslink support post 425 of the crosslink window 440. Similarly, the crosslink support post 425 is shown in the illustrated embodiment to include a single externally formed information indicator 450a. However, in an alternative implementation, the crosslink support post 425 may include two externally formed information indicators 450 at both ends thereof, one extending from its post inflow end 480 and the other extending from its post outflow end 482.

[0094] The information indicator 450b is shown to extend from the post outflow end 482 of the non-crosslink support post 426 in the illustrated embodiment. However, it should be understood that an externally formed information indicator 450 may similarly extend from the post inflow end 480 of the non-crosslink support post 426. Similarly, the non-crosslink support post 426 is shown in the illustrated embodiment to include a single externally formed information indicator 450b. However, in an alternative implementation, the non-crosslink support post 426 may include two externally formed information indicators 450 at both ends thereof, one extending from its post inflow end 480 and the other extending from its post outflow end 482.

[0095] The frame 404 illustrated in FIG. 4 is shown to include both an information indicator 450a formed along the cross-linked support post 425 and an information indicator 450b formed along the non-cross-linked support post 426. However, such a configuration is shown by way of example and is not limiting. The frame 404 can comprise one or more cross-linked support posts 425 that include one or two externally formed information indicators 450, although all non-cross-linked posts 426 lack any information indicators, or the frame 404 can comprise one or more non-cross-linked posts 426 that include one or two externally formed information indicators 450, although all cross-linked support posts 425 lack any information indicators. It should be understood that this is the case.

[0096] Although E-shaped information indicators 450a, 450b are illustrated, it should be understood that any information indicator 450 can be in the shape of any other alphanumeric, symbol, or any other geometric shape. When multiple information indicators, such as in the illustrated embodiment, are provided on a single frame 404, they can be of the same shape or, for example, of different shapes to convey different information details of the artificial valve 400.

[0097] The prosthetic valves 100 and 200 are shown to include information indicators 150 and 250 formed therein, and the prosthetic valve 400 is shown to include an information indicator 450 formed externally. However, in some implementations, a mechanically expandable prosthetic valve similar to any of the prosthetic valves 100, 200, 400 disclosed hereinabove may include a combination of at least one information indicator 150, 250 formed internally and at least one information indicator 450 formed externally, formed within or along the same or different support struts. Implementations of such combinations may have the information indicators formed internally being of a different shape than the information indicators formed externally, with each indicator being designed to convey different information details, where the information indicators formed internally are in the form of alphanumeric characters, symbols, or other geometric shapes that can be appropriately formed within the boundaries of the support posts without impairing the ability to be properly identified by clinical imaging techniques, while the information indicators formed externally may be useful when in the form of alphanumeric characters, symbols, or any other geometric shape that needs to be relatively wide to enable proper identification of its shape by clinical imaging techniques.

[0098] Figure 3 shows a delivery device 300 in one configuration adapted to deliver a mechanically expandable prosthetic valve 360 (e.g., prosthetic valves 100, 200, and 400) described herein. The prosthetic valve 360 may be releasably coupled to the delivery device 300. It should be understood that the delivery device 300 may be used to implant prosthetic devices other than prosthetic valves, such as stents or grafts.

[0099] In the illustrated embodiment, the delivery device 300 generally includes a handle 304, an outer elongate 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 can also include an elongate nose cone shaft 332 extending distally from the handle 304 through the outer shaft 308. The nose cone 340 can be connected to the distal end of the nose cone shaft 332. At least one actuator assembly 320 can be configured to radially expand and / or radially crush the prosthetic valve 360 when actuated.

[0100] As shown, one actuator assembly 320 can be provided for each actuator (e.g., actuator 170, 270, or 470) on the prosthetic valve 360. For example, for a prosthetic valve 360 having six actuators, six actuator assemblies 320 can be provided. However, in other configurations, any greater or fewer number of actuator assemblies can be present.

[0101] The distal end portion of the shaft 308 can be sized and shaped to accommodate the prosthetic valve 360 in a radially compressed delivery state, for example, while delivering the prosthetic valve through a patient's vasculature. In this way, the distal end portion of the shaft 308 functions as a delivery sheath or capsule for the prosthetic valve during delivery.

[0102] 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 respective actuator of the prosthetic valve 360. Each actuator assembly 320 can include a support tube 324, an actuator member (hidden within the support tube 324 in FIG. 3), and optionally a locking tool. In operation, the actuator assembly can transmit a pushing force and / or a pulling force to a portion of the prosthetic valve in order to radially expand and crush the prosthetic valve, as described above. The actuator assembly 320 can be radially disposed at least partially within one or more lumens of the outer shaft 308 and can extend axially therethrough. For example, the actuator assembly 320 can extend through the central lumen of the shaft 308 or can extend through a respective separate lumen formed in the shaft 308.

[0103] As used herein, the terms "releasably coupled" or "releasably attached" are interchangeable and mean that two components are coupled together in a manner that they can be separated without plastically deforming either component.

[0104] Although not shown, the delivery device 300 can include, in some implementations, a multi-lumen delivery shaft that extends through the lumen of the outer shaft and has a plurality of lumens therein. Either the nose cone shaft 332 and / or the actuator assembly 320 can extend through the lumen of the multi-lumen delivery shaft.

[0105] The actuator members of each actuator assembly 320 can be releasably coupled to respective actuators of the prosthetic valve (e.g., actuator 170, 270, or 470). The support tube 324 of each actuator assembly 320 can abut against an adjacent portion of the frame of the prosthetic valve, such as an outflow tip (e.g., tip 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 of the actuator assembly 320 can drive the actuator member of the prosthetic valve and move the inflow end of the prosthetic valve toward the outflow end of the prosthetic valve.

[0106] The handle 304 of the delivery device 300 may include one or more control mechanisms (e.g., knob 306 or other actuation mechanisms) for controlling different components of the delivery device 300 to expand and / or deploy the prosthetic valve 360. For example, in the illustrated embodiment, the handle 304 includes a first knob 306a, a second knob 306b, and a third knob 306c.

[0107] The first knob 306a can be a rotatable knob configured to axially move the outer shaft 308 distally and / or proximally relative to the prosthetic valve 360 for the purpose of deploying the prosthetic valve from the delivery sheath after the prosthetic valve has been driven forward to or adjacent to a desired implantation site within the patient. For example, rotation of the first knob 306a in a first direction (e.g., clockwise) can retract the sheath proximally relative to the prosthetic valve 360, and rotation of 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 by pulling and / or pushing the knob. In yet other configurations, actuation of the first knob 306a, such as by rotation or sliding of the first knob 306a, can cause axial movement of the actuator assembly 320, which in turn can cause axial movement of the prosthetic valve 360 relative to the delivery sheath, advancing the prosthetic valve distally from the sheath.

[0108] The second knob 306b can be a rotatable knob configured to produce radial expansion and / or contraction of the prosthetic valve 360. For example, by rotationally driving the second knob 306b, the actuator member of the actuator assembly 320 and the support tube 324 can be axially moved relative to each other. The actuator member of the assembly 320 then causes corresponding movement of the actuator of the prosthetic valve (e.g., actuator 170, 270, or 470). Rotation of the second knob 306b in a first direction (e.g., clockwise) can radially expand the prosthetic valve 360, and rotation of the second knob 306b in a second direction (e.g., counterclockwise) can radially collapse the prosthetic valve 360. In other configurations, the second knob 306b can be actuated by axially sliding or moving the knob 306b, such as by pulling and / or pushing the knob.

[0109] The third knob 306c can be a rotatable knob configured to hold the prosthetic valve 360 in an expanded state. For example, the third knob 306c can be operably connected to the proximal end portion of the locking tool of each actuator assembly 320. Rotation of the third knob 306b in a first direction (e.g., clockwise) can rotate each locking tool to advance the lock nut to its distal position and resist radial compression of the prosthetic valve's frame. Rotation of 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 examples, the prosthetic valve can be self-locking, in which case the locking tool is not necessary. For example, the frame of the prosthetic valve can include a locking function that automatically engages the actuator member of the prosthetic valve to resist radial compression of the prosthetic valve after expansion, such as those disclosed in U.S. Application No. 63 / 085,947, U.S. Application No. 63 / 138,599, and U.S. Application No. 63 / 179,766.

[0110] Although not shown, the handle 304 can include a fourth rotatable knob operably connected to the proximal end portion of each actuator member. The fourth knob can be configured to rotate each actuator member upon rotational actuation of the knob, thereby allowing each actuator member to be unscrewed from the proximal portion of the corresponding actuator. As described above, the locking tool and the actuator member can be removed from the patient when disengaged from the prosthetic valve 360.

[0111] Figures 5A - 5B illustrate another embodiment of the prosthetic valve 500. The prosthetic valve 500 can be configured to replace a native heart valve (e.g., aortic valve, mitral valve, pulmonary valve, and / or tricuspid valve). The prosthetic valve 500 is illustrated as a balloon-expandable prosthetic valve that is movable between a radially compressed state and a radially expanded state. A balloon-expandable valve generally includes the procedure of expanding a balloon within the prosthetic valve, thereby expanding the prosthetic valve 500 within the 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 coupled to and supported within the frame 504. The valve structure 508 can include one or more valve leaflets 512, which can be the same as any of the embodiments described above with respect to the valve structure 108 and valve leaflets 112, but the detailed description thereof will not be repeated here for brevity. FIG. 5A shows the prosthetic valve 500 having the valve structure 508, and FIG. 5B shows the frame 504 without the valve structure.

[0112] As further shown in FIG. 5A, 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 but not limited to plastically deformable materials such as stainless steel, nickel-based alloys (e.g., cobalt-chromium alloys 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 wound onto a balloon catheter 652 (shown in FIG. 6) into a radially compressed state and then expanded within the patient by an expandable balloon. Alternatively or additionally, the frame 504 can be made of a shape memory material such as nickel-titanium alloy (e.g., Nitinol).

[0113] Frame 504 includes a plurality of intersecting struts including curved or angled struts 532 and vertical struts 528. Frame 504 includes a plurality of strut crossbars that can collectively define one or more columns of cells 536, and the vertical struts 528 of the illustrated embodiment can be formed along the uppermost or most proximal column of cells 536. Frame 504 can have a cylindrical or substantially cylindrical shape with a constant diameter from the inlet end 516 to the outlet end 520 as illustrated, or the frame can have a diameter that varies along the central longitudinal axis C as disclosed in U.S. Patent No. 9,155,619, which is incorporated herein by reference.

[0114] The end portions of the angled struts 532 form an outlet tip 518 at the outlet end 520 and an inlet tip 514 at the inlet end 516. The struts can intersect at additional junctions formed between the outlet tip 518 and the inlet tip 514. The junctions can be equally or unequally spaced from each other and / or from the tips 518, 514 between the outlet end 520 and the inlet end 516.

[0115] The vertical struts 528 can include interconnected struts 529 and unconnected vertical struts 530. The interconnected struts 529 include an interconnect window 540 that can accommodate the interconnect 544 of the valve structure 508, while the unconnected vertical struts 530 lack an interconnect window. Each vertical strut 528 that includes any interconnected strut 529 or unconnected vertical strut 530 extends between a vertical strut inlet end 580 near the inlet end 516 of the valve 500 and a vertical strut outlet end 582 near the outlet end 520 of the valve 500. Two curved or angled struts 532 intersect each vertical strut 528 at a vertical strut inlet end 580 circumferentially disposed between two adjacent inlet tips 514, and two curved or angled struts 532 intersect each vertical strut 528 at a vertical strut outlet end 582 circumferentially disposed between two adjacent outlet tips 518.

[0116] The prosthetic valve 500 can further include an inner skirt (not shown) and / or an outer skirt (not shown in FIGS. 5A-5B but may be generally similar to the outer skirt 924 shown in FIG. 10), which can be implemented according to any of the embodiments described for the prosthetic valve 100, and the detailed description thereof will not be repeated here for the sake of brevity.

[0117] The width of the non-connected vertical struts, or the width (circumferential direction) of the side walls on both sides of the connection window of the connected struts, usually narrows to appropriately accommodate the information indicators formed inside. Thus, the balloon-expandable prosthetic valve disclosed herein preferably includes an information indicator formed externally along a portion of its vertical struts, and the information indicator extends from the vertical strut inflow end or the vertical strut outflow end and provides improved structural stability due to the angled struts or curved struts that converge therewith, and preferably lacks the information indicator formed inside.

[0118] FIGS. 5A-5B show a balloon-expandable prosthetic valve 500 having non-connected vertical struts 530 that include an information indicator 550 formed externally extending from their vertical strut inflow ends 580. As shown, the non-connected vertical struts 530 can have a width W9 in the circumferential direction, while the information indicator 550 formed therealong can have a width W10 in the circumferential direction such that W10 > W9. In some implementations, the non-connected vertical struts 530 that are narrower than the information indicator 550 can be aligned with one circumferential side surface of the information indicator 550 or can be aligned with the circumferential center of the information indicator 550 (not shown), as shown in the exemplary embodiment.

[0119] In FIGS. 5A - 5B, the information indicator 550 is illustrated as being wider than the non - connected vertical strut 530. However, in other implementations (not shown), the width of the externally formed information indicator 550 may be equal to the width of the non - connected vertical strut 530 (i.e., W9 = W10). Nevertheless, the wider information indicator 550 can advantageously function as a support member to which other components can be attached. For example, in some implementations, sensors (e.g., pressure sensors, flow sensors, temperature sensors, etc.) can be coupled to the information indicator 550.

[0120] In the illustrated embodiment, the information indicator 550 is shown to extend from the vertical strut inflow end 580 of the non - connected vertical strut 530. However, it should be understood that the externally formed information indicator 550 can similarly extend from the vertical strut outflow end 582 of the non - connected vertical strut 530. Similarly, in the illustrated embodiment, each non - connected vertical strut 530 is shown to include a single externally formed information indicator 550. However, in alternative implementations, the non - connected vertical strut 530 can include two externally formed information indicators 550 at both of its ends, one extending from its vertical strut inflow end 580 and the other extending from its vertical strut outflow end 582. Nevertheless, in some implementations, 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 compared to the cells in the other rows of the artificial valve. A frame designed with higher outflow cells 536 can provide a more open space for blood flow and coronary access. When the width W10 of the information indicator 550 is greater than the width W9 of the non - connected vertical strut 530, forming the wider information indicator 550 at the vertical strut inflow end 580 advantageously provides a space (not blocked by the wider information indicator) opened by the outflow end of the frame to increase blood flow and coronary access.

[0121] An E-shaped information indicator 550 is illustrated, but it should be understood that the externally formed information indicator 550 may be in the shape of any other alphanumeric, symbol, or any other geometric shape. In the embodiment illustrated in FIG. 5B, it is shown that a single externally formed information indicator 550 is formed along three non-connected vertical struts 530, but it should be understood that any other number of non-connected vertical struts 530 may include one or two externally formed information indicators 550. If multiple externally formed information indicators 550 are included, they may be of the same shape or, for example, of different shapes to convey different information details of the prosthetic valve 500. In some implementations, one or more information indicators can further function as a support structure to which the soft components of the prosthetic valve can be coupled. For example, a skirt (such as an inner skirt and / or an outer skirt) and / or a portion of the leaflet of the prosthetic valve can be sutured to a portion of one or more information indicators.

[0122] As described above, support posts such as the non-connected support posts 526 formed internally may not provide sufficient space to contain both digits, so in some implementations, two adjacent support posts such as two adjacent non-connected support posts 526 can each contain one of the digits of the two-digit deployed diameter, and these may be similar to or different from each other. For example, for a prosthetic valve having a deployed diameter of 23 mm, one externally formed information indicator formed on the first non-connected support post 526 can take the form of the first digit (e.g., "2"), while another externally formed information indicator formed on a second non-connected support post 526 adjacent to the first non-connected support post 126 can take the form of the second digit (e.g., "3").

[0123] Figures 7A - 7B show another exemplary artificial valve 700 shown without soft components (such as skirts or valve structures) for clarity. The artificial valve 700 is shown to have cross - linked struts 729 including information indicators 750 formed externally extending from their respective vertical strut inflow ends 780. Except for this, the artificial valve 700 is structurally similar to the described artificial valve 500 and can function in a similar manner. For example, the artificial valve 700 can include a frame 704 extending between an inflow end 716 and an outflow end 720. The frame 704 includes a plurality of vertical struts 728 including cross - linked struts 729 with cross - linked windows 740 and non - cross - linked vertical struts 730 lacking cross - linked windows. The frame 704 can also include a plurality of curved or angled struts 732 that intersect other angled struts 732 and interconnect the vertical struts 728. The struts 732 and the vertical struts 728 define cells 736 of the frame 704. Figure 7A shows the annular configuration of the frame 704, while Figure 7B shows a portion of the flattened configuration of the frame 704 for illustrative purposes.

[0124] Each vertical strut 728, including any cross - linked strut 729 or non - cross - linked vertical strut 730, extends between a vertical strut inflow end 780 near the inflow end 716 of the valve 700 and a vertical strut outflow end 782 near the outflow end 720 of the valve 700. Two curved or angled struts 732 intersect each vertical strut 728 at a vertical strut inflow end 780 circumferentially disposed between two adjacent inflow tips 714, and the two curved or angled struts 732 intersect each vertical strut 728 at a vertical strut outflow end 782 circumferentially disposed between two adjacent outflow tips 718. Other structural and functional components of the artificial valve 700 can be similar to those described above with respect to the artificial valve 500. Similar numbers refer to similar components and, for the sake of brevity, will not be further described.

[0125] As shown in FIGS. 7A - 7B, both the cross - linked strut 729 and the information indicator 550 can have the same width W12 common in the circumferential direction. In other implementations, the width of the information indicator 550 may be greater than the width of the cross - linked strut 729. The non - cross - linked vertical strut 730 can have a circumferential width W11, which may be similar to the width of the cross - linked strut 729, or since the non - cross - linked vertical strut 730 does not include the cross - linked window 740, it may be narrower than the width of the cross - linked strut 729.

[0126] In some implementations, as shown for the frame 704, one or more of the non - cross - linked vertical struts 730 can have a wide vertical strut inlet end 780 that is wide (with respect to W11) at its middle portion. In some implementations, the vertical strut inlet end 780 of the non - cross - linked vertical strut 730 can include an opening 742. The opening 742 can be configured to receive a fastening member (e.g., a suture) for attaching a soft component of the artificial valve 700 to the frame 704. For example, in some implementations, an outer skirt can be positioned around the outer surface of the frame 704 and fixed to the opening 742. Although the non - cross - linked vertical strut 730 including the wide vertical strut inlet end 780 having the opening 742 has been illustrated and described with respect to the artificial valve 700, it should be understood that the artificial valve 500, as well as any other balloon - expandable artificial valve disclosed herein, can include at least one non - cross - linked vertical strut that includes a wide vertical strut inlet end having an opening.

[0127] Although an E - shaped information indicator 750 is illustrated, it should be understood that the information indicator 750 can be in the shape of any other alphanumeric, symbol, or any other geometric shape. In the embodiment illustrated in FIG. 7A, a single information indicator 750 is shown to be formed along all three cross - linked struts 729, but it should be understood that any other number of cross - linked struts 729 can include the externally formed information indicator 750.

[0128] Figures 8A - 8B show another exemplary artificial valve 800 shown without soft components (such as a skirt or valve structure) for clarity. Artificial valve 800 is shown to have cross - linked struts 829 that include information indicators 850 formed externally extending from their respective vertical strut outflow ends 880. Except for this, artificial valve 800 is structurally similar to the described artificial valves 500 or 700 and can function in a similar manner. For example, artificial valve 800 can include a frame 804 that extends between an inflow end 816 and an outflow end 820. Frame 804 includes a plurality of vertical struts 828 that include cross - linked struts 829 with cross - linked windows 840 and non - cross - linked vertical struts 830 without cross - linked windows. Frame 804 can also include a plurality of curved or angled struts 832 that intersect other angled struts 832 and interconnect the vertical struts 828, and the struts 832 and vertical struts 828 define cells 836 of the frame 804. Figure 8A shows the annular configuration of the frame 804, while Figure 8B shows a portion of the flattened configuration of the frame 804 for illustrative purposes.

[0129] Each vertical strut 828 that includes any cross - linked strut 829 or non - cross - linked vertical strut 830 extends between a vertical strut inflow end 880 near the inflow end 816 of the valve 800 and a vertical strut outflow end 882 near the outflow end 820 of the valve 800. Two curved or angled struts 832 intersect each vertical strut 828 at a vertical strut inflow end 880 circumferentially disposed between two adjacent inflow tips 814, and the two curved or angled struts 832 intersect each vertical strut 828 at a vertical strut outflow end 882 circumferentially disposed between two adjacent outflow tips 818. Other structural and functional components of the artificial valve 800 can be similar to those described with respect to the artificial valves 500 or 700, and like numbers refer to like components and are not further described for brevity.

[0130] As shown in FIGS. 8A-8B, the cross-linked strut 829 can have a width W14 in the circumferential direction, and the externally formed information indicator 850 can have a width W15 in the circumferential direction such that, as shown in the illustrated embodiment, W15 is substantially equal to W14 (W15 = W14), or W15 can be greater than W14 (W15>W14). The non-cross-linked vertical strut 830 can have a circumferential width W13, which may be similar to the width W14 of the cross-linked strut 829, or the non-cross-linked vertical strut 830 may be narrower than the width W14 since it does not include the cross-linked window 840. As further shown, at least one non-cross-linked vertical strut 830 can optionally include a wide vertical strut inlet end 880 having an opening 842 and having a width.

[0131] Although an E-shaped information indicator 850 is illustrated, it should be understood that the information indicator 850 can be in the shape of any other alphanumeric, symbol, or any other geometric shape. In the embodiment illustrated in FIG. 8A, it is shown that a single information indicator 850 is formed along all three cross-linked struts 829, but it should be understood that any other number of cross-linked struts 829 can include the externally formed information indicator 850.

[0132] Interconnected struts 729 having information indicators 750 extending from their vertical strut inlet ends 780 are illustrated in FIGS. 7A-7B, and interconnected struts 829 having information indicators 850 extending from their vertical strut outlet ends 882 are illustrated in FIGS. 8A-8B, but it should be understood that these features can be combined such that one or more of the allowable struts will include an externally formed information indicator extending from its vertical strut inlet end, and one or more other interconnected struts will include an externally formed information indicator extending from its vertical strut outlet end. Further, in some implementations, any such frame can include one or more interconnected struts with two information indicators disposed on either side thereof, one of which extends from its vertical strut inlet end and the other of which extends from its vertical strut outlet end. Further, the frame of the balloon-expandable valve can include a combination of one or more interconnected struts having one or two externally formed information indicators formed therealong and at least one non-interconnected vertical strut having one or two externally formed information indicators formed therealong. If multiple externally formed information indicators are included, they may be of similar shape or of different shapes.

[0133] Figures 9-10 show another exemplary artificial valve 900. As will be described in more detail below, the artificial valve 900 is structurally similar to the described artificial valve 700 and can function in a similar manner, except that the artificial valve 900 further includes support struts 970. For example, the artificial valve 900 can include a frame 904 that extends between an inflow end 916 and an outflow end 920, and the frame 904 includes a plurality of vertical struts 928 that include interconnected struts 929 with fenestrations 940 and non-interconnected vertical struts 930 that lack fenestrations. The frame 904 can also include a plurality of curved or angled struts 932 that intersect other angled struts 932 and interconnect the vertical struts 928, and the struts 932 and vertical struts 928 define cells 936 of the frame 904. FIG. 9 shows a portion of the flattened configuration of the frame 904, while FIG. 10 shows an annular configuration of the artificial valve 900 that includes a valve structure 908 with valve tips 912 and an outer skirt 924 disposed around the frame 904.

[0134] Each vertical strut 928 that includes any interconnected strut 929 or non-interconnected vertical strut 930 extends between a vertical strut inflow end 980 that is close to the inflow end 916 of the valve 900 and a vertical strut outflow end 982 that is close 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 that is circumferentially disposed between two adjacent inflow tips 914, and the two curved or angled struts 932 intersect each vertical strut 928 at the vertical strut outflow end 982 that is circumferentially disposed between two adjacent outflow tips 918. Other structural and functional components of the artificial valve 900 can be similar to those described with respect to the artificial valve 700, and like numbers refer to like components and will not be further described for the sake of brevity.

[0135] As shown in FIG. 9, the cross-linking struts 929 each include an externally formed information indicator 950 that extends distally of the cross-linking window 940 from each vertical strut outflow end 980. Although each cross-linking strut 929 is shown to include a single information indicator 950 extending from the vertical strut outflow end 980, in some implementations, at least one cross-linking strut 929 can include two externally formed information indicators 950 at both of its ends, one extending from its vertical strut inflow end 980 and the other extending from its vertical strut outflow end 982. Further, although all non-cross-linking vertical struts 930 are shown without information indicators, in some implementations, at least one non-cross-linking vertical strut 930 of the frame 904 can further include one or two externally formed information indicators 950.

[0136] FIG. 10 shows an outer skirt 924 disposed around 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 suture threads 926 that can be wrapped around the angled struts 932 of the frame 904. The inflow end portion of the outer skirt 924 can be sutured to the angled strut 932 along the inflow end 916 of the artificial valve 900, while the outflow end 922 of the outer skirt 924 is disposed along the upper or most proximal row of cells 936 that are generally axially longer than the other cells 936 of the frame 904 because these cells include the vertical struts 928, creating a large opening defined by the cells 936 of the upper row. Such an enlarged cell opening creates a void that cannot provide sufficient support for the outflow end 922 of the outer skirt 924, which can result in a portion of the outer skirt 924 bulging somewhat radially inwardly through these cell openings or can limit the overall height of the outer skirt 924 such that it terminates at its outflow end 922 below the opening of the uppermost cell 936.

[0137] As shown in FIG. 9, the frame 904 further includes support struts 970, which can be curved or inclined support struts such that at least two support struts 970 extend between at least two adjacent vertical struts 928 and intersect each other at support tips 972 that can be axially aligned with corresponding outflow tips 918. At least one support strut 370 extends from an externally formed information indicator 950.

[0138] The shape of a part of the externally formed information indicator, such as an E-shaped or 3-shaped information indicator, may include portions that can be advantageously utilized as structural base members from which the support struts can extend in a stable manner. For example, the E-shaped externally formed information indicator 950 shown in FIG. 9 includes an inflow portion 958 at its end that coincides with a vertical strut inflow end 980 connected to two angled struts 932, an outflow portion 956 at its opposite end near the cross-connection window 940, and a central portion 954 disposed therebetween in the form of a laterally (or circumferentially) oriented extension.

[0139] As shown, at least one support strut 970 can extend from the central portion 954 and intersect another support strut 970 extending from an adjacent non-connected vertical strut 930. In some implementations, the non-connected vertical strut 930 includes a short lateral extension 946 from which the corresponding support strut 970 can extend. As shown, when two support struts 970 extend in opposite directions from the same non-connected vertical strut 930, the non-connected vertical strut 930 can include two lateral extensions 946 oriented in opposite lateral directions (perpendicular to the axial direction of the vertical strut 930) to support both support struts 970 extending therefrom. The lateral extensions 946 can be axially aligned with the corresponding central portion 954 of the information indicator 950.

[0140] Frame 904 preferably includes two support struts 970 that intersect each other between each adjacent pair of vertical struts 928 along the upper or most proximal row of cells 936. As shown in FIG. 10, the outflow end 922 of the outer skirt 924 can be attached to the support strut 970, for example, via a suture 926. As further shown in FIG. 9, since the support strut 970 mainly serves to support the attachment of the outer skirt, it does not need to withstand significant loads or experience the same stress levels as the other struts 932 of the frame 904. Thus, it can be relatively narrower and / or thinner than the other angled struts 932, thus avoiding the risk of significantly increasing the crimped profile of the prosthetic valve 900 during delivery.

[0141] FIG. 11 shows a portion of a flattened configuration of a frame 1004 of another exemplary prosthetic valve 1000. The prosthetic valve 1000 is structurally similar to the described prosthetic valve 900 and can function in a similar manner, except that at least one support strut 1070 extends from the outflow portion 1056 of an information indicator 1050 formed externally, rather than from its central portion. For example, the prosthetic valve 1000 includes a frame 1004 that extends between an inflow end 1016 and an outflow end 1020, and the frame 1004 includes a plurality of vertical struts 1028 that include interconnected struts 1029 with communication windows 1040 and non-connected vertical struts 1030 that lack communication windows. The frame 1004 can also include a plurality of curved or angled struts 1032 that intersect the other angled struts 1032 and interconnect the vertical struts 1028, and the struts 1032 and the vertical struts 1028 define cells 1036 of the frame 1004.

[0142] Each vertical support 1028, including any cross-linked support 1029 or non-cross-linked vertical support 1030, extends between a vertical support inlet end 1080 near the inlet end 1016 of the valve 1000 and a vertical support outlet end 1082 near the outlet end 1020 of the valve 1000. Two curved or angled supports 1032 intersect each vertical support 1028 at the vertical support inlet end 1080 circumferentially disposed between two adjacent inlet tips 1014, and the two curved or angled supports 1032 intersect each vertical support 1028 at the vertical support outlet end 1082 circumferentially disposed between two adjacent outlet tips 1018.

[0143] The cross-linked support 1029 includes an externally formed information indicator 1050 that extends distally from each respective vertical support outlet end 1080 to beyond the cross-linked window 1040. The frame 1004 further includes support struts 1070, which can be curved or angled support struts such that at least two support struts 1070 extend between at least two adjacent vertical supports 1028 and intersect each other at support tips 1072 that can be axially aligned with the corresponding outlet tips 1018, and at least one support strut 1070 extends from the externally formed information indicator 1050. The information indicator 1050, illustrated as an E-shaped indicator in the illustrated embodiment (although other shapes can be had in other embodiments), can include an inlet portion 1058 at its end connected to the two angled supports 1032, an outlet portion 1056 at its opposite end near the cross-linked window 1040, and a central portion 1054 disposed therebetween in the form of an extension oriented laterally (or circumferentially). Other structural and functional components of the artificial valve 1000 can be similar to those described above with respect to the artificial valve 900, and like numbers refer to like components and will not be further described for the sake of brevity.

[0144] As described above and as shown in FIG. 11, at least one support strut 1070 can extend from the outflow portion 1056 and intersect another support strut 1070 that extends from an adjacent non-connected vertical strut 1030. In some implementations, the non-connected vertical strut 1030 includes a short lateral extension 1046 from which a corresponding support strut 1070 can extend. As shown, when two support struts 1070 extend from the same non-connected vertical strut 1030 in opposite directions, the non-connected vertical strut 1030 can include two lateral extensions 1046 that are oriented in opposite lateral directions (perpendicular to the axial direction of the vertical strut 1030) to support both support struts 1070 that extend therefrom. The lateral extensions 1046 can be axially aligned with the corresponding outflow portions 1056 of the information indicator 1050. The configuration shown in FIG. 11 can be more advantageous than the configuration shown in FIG. 9 in that the outflow portion 1056, which can also extend continuously and form part of the inflow end of the interconnected window 1040, provides a more rigid and stable support by the support struts 1070 extending therefrom, for example, as compared to the central portion 1054.

[0145] The frame 1004 preferably includes two support struts 1070 that intersect each other between each adjacent pair of vertical struts 1028 along the upper or most proximal row of the cells 1036. The outflow end portion of the outer skirt can be attached to the support strut 1070 in the same manner as described above with respect to FIG. 10. As further shown in FIG. 11, since the support strut 1070 mainly serves to support the attachment of the outer skirt, it does not need to withstand significant loads or experience the same stress levels as the other struts 1032 of the frame 1004, and thus can be relatively narrower and / or thinner than the other angled struts 1032, thus avoiding the risk of significantly increasing the crimped profile of the prosthetic valve 1000 during delivery.

[0146] Each cross-linking strut 1029 is shown to include a single information indicator 1050 extending from the vertical strut outflow end 1080. However, in some implementations, at least one cross-linking strut 1029 can include two externally formed information indicators 1050 at both ends thereof, one extending from its vertical strut inflow end 1080 and the other extending from its vertical strut outflow end 1082. Further, all non-cross-linking vertical struts 1030 are shown without information indicators, but in some implementations, at least one non-cross-linking vertical strut 1030 of the frame 1004 can further include one or two externally formed information indicators 1050.

[0147] Figures 12A - 12B show another exemplary artificial valve 1100 shown without soft components (such as skirts or valve structures) for clarity. The artificial valve 1100 can be structurally similar to the described artificial valve 700 and function in a similar manner, except for the features described below. For example, the artificial valve 1100 can 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 including cross-linking struts 1129 with cross-linking windows 1140 and non-cross-linking vertical struts 1130 lacking cross-linking windows. The frame 1104 can also include a plurality of curved or angled struts 1132 that intersect other angled struts 1132 and interconnect the vertical struts 1128, the struts 1132 and the vertical struts 1128 defining cells 1136 of the frame 1104. Figure 12A shows the annular configuration of the frame 1104, while Figure 12B shows a portion of the flattened configuration of the frame 1104 for illustrative purposes.

[0148] Each vertical strut 1128, including any cross-linked strut 1129 or non-cross-linked vertical strut 1130, extends between a vertical strut inlet end 1180 close to the inlet end 1116 of the valve 1100 and a vertical strut outlet end 1182 close to the outlet end 1120 of the valve 1100. Two curved or angled struts 1132 intersect each vertical strut 1128 at the vertical strut inlet end 1180 circumferentially disposed between two adjacent inlet tips 1114, and the two curved or angled struts 1132 intersect each vertical strut 1128 at the vertical strut outlet end 1182 circumferentially disposed between two adjacent outlet tips 1118. Other structural and functional components of the prosthetic valve 1100 may be similar to those described above with respect to the prosthetic valve 700, and like numbers refer to like components and will not be further described for the sake of brevity.

[0149] In the illustrated embodiment, the frame 1104 is shown to include two different types of information indicators 1150, such as an E-shaped information indicator 1150a extending from the inlet portion 1180 of the cross-linked strut 1129 and a 3-shaped information indicator 1150b extending from the outlet portion 1182 of the non-cross-linked vertical strut 1130. However, this combination is shown by way of example and not limitation, and the frame 1104 can include more or fewer information indicators 1150 formed similarly or differently, and it should be understood that each externally formed information indicator 1150 can be in the shape of any other alphanumeric, symbol, or any other geometric shape.

[0150] The information indicator 1150b is shown to be formed along all six non-cross-linked vertical struts 1130 in the embodiment illustrated in FIG. 12A, but it should be understood that any other number of non-cross-linked vertical struts 1130 can include the externally formed information indicator 1150b. Similarly, the information indicator 1150a is shown to be formed along all three cross-linked struts 1129 in the embodiment illustrated in FIG. 12A, but it should be understood that any other number of allowable struts 1129 can include the externally formed information indicator 1150a.

[0151] In the illustrated embodiment, the information indicator 1150a is shown to extend from the vertical support inflow end 1180 of the cross-linking support 1129. However, it should be understood that an externally formed information indicator 1150a may similarly extend from the vertical support outflow end 1182 of the cross-linking support 1129. Similarly, in the illustrated embodiment, each cross-linking support 1129 is shown to include a single externally formed information indicator 1150a. However, in an alternative implementation, the cross-linking support 1129 can include two externally formed information indicators 1150a at both ends thereof, one extending from the vertical support inflow end 1180 and the other extending from the vertical support outflow end 1182.

[0152] In the illustrated embodiment, the information indicator 1150b is shown to extend from the vertical support outflow end 1182 of the non-cross-linking vertical support 1130. However, it should be understood that an externally formed information indicator 1150b may similarly extend from the vertical support inflow end 1180 of the non-cross-linking vertical support 1130. Similarly, in the illustrated embodiment, each non-cross-linking vertical support 1130 is shown to include a single externally formed information indicator 1150b. However, in an alternative implementation, the non-cross-linking vertical support 1130 can include two externally formed information indicators 1150b at both ends thereof, one extending from its vertical support inflow end 1180 and the other extending from its vertical support outflow end 1182.

[0153] As shown in FIG. 12B, the non-interconnected vertical strut 1130 can have a width W16 in the circumferential direction, and the externally formed information indicator 1150b formed along it can have a width W17 such that W17 is greater than W16 (W17>W16). The interconnected strut 1129 can have a width W19 in the circumferential direction, and the externally formed information indicator 1150a formed along it can have a width W18 in the circumferential direction such that, as shown in the illustrated embodiment, W18 can be substantially equal to W19 (W18 = W19), or W18 can be greater than W19 (W18>W19). The width W19 of the interconnected strut 1129 can be equal to the width W16 of the non-interconnected vertical strut 1130, or, as shown, since the non-interconnected vertical strut 1130 does not include the interconnected window 1140, W19 can be greater than W16. As further shown, at least one non-interconnected vertical strut 1130 can optionally include a wide vertical strut inlet end 1180 having an opening 1142 with a width.

[0154] In some embodiments, the externally formed information indicator 1150b formed along the non-interconnected vertical strut 1130 can protect the valve tip during crimping. When the prosthetic valve 1100 is positioned in a crimping device and the valve is radially compressed to a smaller diameter for insertion into a patient, the valve tip is pressed against the inner surface of the metal frame 1104, and a portion of the tissue (e.g., in the case of a valve tip made of tissue material) can protrude into the open cells of the frame between the struts and can be pinched by the scissor-like movement of the struts of the frame. If the valve is severely crimped to achieve a small crimp size, this scissor-like movement can result in cutting and destruction of the tissue valve tip.

[0155] In the illustrated embodiment, the wider information indicator 1150b may have a width designed to limit the crimped size so as to maintain a minimum circumferential space between adjacent vertical struts 1128. Specifically, when the prosthetic valve 1100 is crimped, adjacent vertical struts move closer to each other and may pinch the valve tip 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, the compression of the prosthetic valve 1100 will stop when the information indicator 1150b formed outside the non-articulating vertical struts 1130 contacts another information indicator 1150b of an adjacent non-articulating vertical strut 1130 or contacts an adjacent articulating strut 1129.

[0156] When the curling stops when two adjacent information indicators 1150b of two adjacent non - connected vertical struts 1130 come into contact with each other, the resulting minimum lateral space between the adjacent non - connected vertical struts 1130 is equal to the difference between widths W17 and W16 (i.e., W17 - W16). When the curling is stopped when the information indicator 1150 contacts the adjacent interconnected strut 1129, the resulting minimum lateral space between the adjacent non - connected vertical strut 1130 and the interconnected strut 1129 is equal to half of the difference between widths W17 and W16 (i.e., [W17 - W16] / 2). When a single valve tip extends through such a space formed between adjacent vertical struts 1128, it may be desirable for this space to be large enough to accommodate both layers of the folded - over portions that overlap each other. Thus, twice the thickness Tl of the valve tip should be extendable between adjacent vertical struts 1128 without being forcedly pinched. In some implementations, the difference (W17 - W16) is at least twice the size of the thickness Tl of the valve tip. In some implementations, half of this difference (i.e., [W17 - W16] / 2) is at least twice the thickness Tl of the valve tip, meaning that the difference (W17 - W16) is at least four times the thickness Tl of the valve tip. In some cases, the tissue material of the valve tip (e.g., pericardium) can be compressed up to approximately half of its free (i.e., uncompressed) 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 Tl of the valve tip (when the valve tip extends between two adjacent non - connected vertical struts 1130) or at least twice as large as the thickness Tl of the valve tip (when the valve tip extends between a non - connected vertical strut 1130 and an interconnected strut 1129).

[0157] Although an optional interaction between adjacent information indicators 1150b of two adjacent non-connected vertical struts 1130, or between the information indicator 1150b of a non-connected vertical strut 1130 and an adjacent connected strut 1129, has been described above, for a connected strut that does not include an information indicator 1150 at the same axial position as the axial position of the information indicator 1150b of the non-connected vertical strut 1130, in an alternative implementation, it should be understood that the crimping can be stopped when the information indicator 1150b of the non-connected vertical strut 1130 contacts an adjacent information indicator 1150a formed at the same axial position of the connected strut 1129. For example, the connected strut 1129 may include an information indicator 1150a extending from its vertical strut outflow end 1182, configured to approach an adjacent information indicator 1150b extending from the vertical strut outflow end 1182 of an adjacent non-connected vertical strut 1130 during crimping until it makes maximum full contact. This can be advantageous when the information indicator 1150a of the connected strut 1129 has a W18 that is greater than the width W19 of the connected strut 1129.

[0158] When the information indicator 1150 is further utilized as a stopper that limits the minimum crimp diameter of the artificial valve 1000 as described above, as shown for the information indicator 1150b of the illustrated embodiment, it may be preferable that they extend from a vertical strut outflow end 1182 disposed at an axial height proximal to the valve tip to prevent such valve tips from being inadvertently pinched by the information indicator 1150 itself. The frame of the artificial valve, including interconnected angled struts such as the frame 1104, shortens during expansion such that its length in the expanded state, referred to as H1, is less than its length in the crimped state, referred to as H2 (i.e., H1 < H2). The valve tip of the valve structure may include relatively high tabs that extend through the communication window to form a communication such that the outflow ends of the remaining portions of the valve tip extend radially inwardly and somewhat distally from their respective communications 1144. Since the frame 1104 elongates during crimping, the outflow portion of the valve tip may extend further proximally in the crimped state of the artificial valve.

[0159] To reduce the risk that the tip material is pinched between the information indicator 1150b extending from the vertical support outflow end 1182 of the non-connected vertical support 1130 and the side wall of the communication window 1140 of the adjacent connected support 1129, a minimum distance L1 can be defined between the outflow edge 1138 of the communication window 1140 and the lower edge of the information indicator 1150b that can be defined by its inflow portion 1158. Thus, L1 can be defined as the outflow edge 1138 of the communication window and the inflow portion 1158 of the information indicator 1150b extending from the vertical support outflow end 1182 of the adjacent non-connected vertical support 1130. In some implementations, the distance L1 is less than the difference in height of the frame 1104 between its crimped state and its expanded state (i.e., L1 < H2 - H1). The axial height H1 or H2 is measured between the inflow end 1116 and the outflow end 1120.

[0160] As described above with respect to the externally formed information indicators 950 and 1050, some information indicators can be shaped to include a central portion in the form of an extension of a laterally oriented free end. Two such shapes, namely the E-shaped information indicator 1150a and the information indicator 1150b of the shape of 3, are shown enlarged in the section of FIG. 12B and each includes an inflow portion 1158 at an end connected to two angled supports 1132, an outflow portion 1156 at the opposite end, and a central portion 1154 disposed therebetween in the form of a laterally oriented extension.

[0161] In some implementations, the central portion 1154 can be further utilized as a structural element to which soft components of the prosthetic valve 1100, such as an inner skirt, an outer skirt, or a valve tip, can be attached, such as by being sutured thereto. However, when the central portion is formed as an extension of a free end having a uniform width (defined between the proximal and distal edges of the central portion), suture threads wound around or tied to it can slip from that free end. To prevent the suture threads from slipping from the central portion of the information indicator, in some implementations, the central portion can further include a lateral body 1160 that extends laterally (e.g., substantially parallel to the outflow portion 1156 and / or the inflow portion 1158) and terminates at a bidirectional vertical extension 1162 at the free end of the central portion 1154. The bidirectional vertical extension 1162 can be perpendicular to the lateral body 1160 and extend in both the proximal and distal directions from the free end of the central portion 1154. This creates two shoulders 1164 formed at the transition from the lateral body 1160 to the bidirectional vertical extension 1162, which can function to better hold suture threads attached to the central portion 1154 and prevent them from slipping therefrom.

[0162] FIG. 13 shows a portion of a flattened configuration of a frame 1204 of another exemplary prosthetic valve 1200. The prosthetic valve 1200 is structurally similar to any of the prosthetic valves 500, 500, 700, 800, 900, 1000, and 1100 described above and can function in a similar manner. For example, the prosthetic valve 1200 includes a frame 1204 that extends between an inflow end 1216 and an outflow end 1220, and the frame 1204 includes a plurality of vertical struts 1228 that include interconnected struts 1229 with commissural windows 1240 and non-commissural vertical struts 1230 that lack commissural windows. The frame 1204 can also include a plurality of curved or angled struts 1232 that intersect other angled struts 1232 and interconnect the vertical struts 1228, and the struts 1232 and the vertical struts 1228 define cells 1236 of the frame 1204.

[0163] Each vertical strut 1228, including any interconnected strut 1229 or non-interconnected vertical strut 1230, extends between a vertical strut inlet end 1280 near the inlet end 1216 of the valve 1200 and a vertical strut outlet end 1282 near the outlet end 1220 of the valve 1200. Two curved or angled struts 1232 intersect each vertical strut 1228 at the vertical strut inlet end 1280 circumferentially disposed between two adjacent inlet tips 1214, and the two curved or angled struts 1232 intersect each vertical strut 1228 at the vertical strut outlet end 1282 circumferentially disposed between two adjacent outlet tips 1218. Other structural and functional components of the artificial valve 1200 can be similar to those described with respect to any of the artificial valves 500, 500, 700, 800, 900, 1000, and 1100 described above, with like numbers referring to like components and, for the sake of brevity, will not be further described.

[0164] As described above, in some implementations, since the vertical struts 1228, such as the interconnected struts 1229 or the non - interconnected vertical struts 1230, may not provide enough space to include both digits, two adjacent vertical struts 1228, for example, an interconnected strut 1229 and an adjacent non - interconnected vertical strut 1230, or any two adjacent non - interconnected vertical struts 1230, etc., can each include one of the two - digit deployment diameter digits, which may be similar or different from each other. In the illustrated embodiment, for an artificial valve having a deployment diameter of 23 mm, one externally - formed information indicator 1250a formed on a non - interconnected vertical strut 1230a can take the form of the first digit (e.g., "2"), while another externally - formed information indicator 1250b formed on a second non - interconnected vertical strut 1230b adjacent to the first non - interconnected vertical strut 1230a can take the form of the second digit (e.g., "3"). In another embodiment (not shown), one externally - formed information indicator 1250 formed on an interconnected strut 1229 can take the form of the first digit (e.g., "2"), while another externally - formed information indicator 1250 formed on a non - interconnected vertical strut 1230 adjacent to the interconnected strut 1229 can take the form of the second digit (e.g., "3"). Although the artificial valve 1200 is described and illustrated as including at least two externally - formed information indicators 1250 along two adjacent vertical struts 1228, it should be understood that any such combination can be implemented with the necessary modifications for any of the artificial valves 500, 500, 700, 800, 900, 1000, and 1100 described above.

[0165] Although described with respect to the balloon - expandable artificial valve 1100, the externally - formed information indicators of the other artificial valves disclosed herein, including any of the information indicators 550, 750, 850, and 1050 of the balloon - expandable artificial valves 500, 700, 800, and 1000, and the information indicator 450 of the mechanically - expandable artificial valve 400, can similarly be designed to include a central portion having a lateral body that terminates in a bi - directional vertical extension with the necessary modifications.

[0166] FIG. 6 shows a delivery device 600 according to one configuration adapted to deliver a balloon-expandable prosthetic valve 660 (e.g., prosthetic valves 500, 700, 800, 900, 1000, and 1100) described herein. It should be understood that the delivery device 600 can be used to implant prosthetic devices other than prosthetic valves, such as stents or grafts.

[0167] The delivery device 600 includes a handle 604 and a balloon catheter 652 having an inflatable balloon 650 attached to its distal end. The balloon-expandable prosthetic valve 660 can be carried in a crimped state on the balloon catheter 652. Optionally, an outer delivery shaft 624 can extend concentrically over the balloon catheter 652, and a push shaft 620 can be disposed on the balloon catheter 652, optionally between the balloon catheter 652 and the outer delivery shaft 624.

[0168] 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, by moving the outer delivery shaft 624 proximally relative to the balloon catheter 652 or the balloon catheter 652 distally relative to the outer delivery shaft 624, the prosthetic valve 660 can be exposed from the outer delivery shaft 624. The delivery device 600 can further include a nose cone 640 carried by a nose cone shaft (not visible in the view of FIG. 6) extending through the lumen of the balloon catheter 652. The nose cone 640 and the nose cone shaft can be the same as the nose cone 340 and the nose cone shaft 332 described for the delivery device 300, and their detailed description is not repeated here for the sake of brevity.

[0169] The proximal ends of the balloon catheter 652, outer delivery shaft 624, push shaft 620, and optionally the nose cone shaft, may be coupled to the handle 604. During delivery of the prosthetic valve 660, the handle 604 is operable 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 vasculature, and to inflate the balloon 650 mounted on the balloon catheter 652 to expand the prosthetic valve 660, and, once the prosthetic valve 660 is attached at the implantation site, to deflate the balloon 650 and retract the delivery device 600.

[0170] 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 illustrated embodiment, the handle 604 includes an adjustment member, such as the illustrated rotatable knob 660a, which is operably coupled to the proximal end portion of a pull wire. The pull wire may 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. By rotating the knob 660a, the tension of the pull wire may be increased or decreased, thereby adjusting the curvature of the distal end portion of the delivery device 600. Further details regarding the steering or bending mechanism for the delivery device can be found in U.S. Patent No. 9,339,384, which is hereby incorporated by reference herein. The handle 604 may further include an adjustment mechanism including an adjustment member, such as the illustrated rotatable knob 606b. The adjustment mechanism may be configured to adjust the axial position of the push shaft 620 relative to the balloon catheter.

[0171] The prosthetic valve 660 can be carried by the delivery device 600 during delivery in a crimped state and expanded by balloon inflation to secure it to the native heart valve annulus. In one exemplary implantation procedure, the prosthetic valve 660 is first crimped onto the balloon catheter 652 proximal to the inflatable balloon 650. Since the prosthetic valve 660 is crimped at a location different from the location of the balloon 650, the prosthetic valve 660 can be crimped to a lower profile than would be possible if it were crimped onto the balloon 650. This lower profile allows the clinician to more easily maneuver the delivery device 600 (including the crimped prosthetic valve 660) through the patient's vasculature to the treatment site. The lower profile of the crimped prosthetic valve is particularly advantageous when maneuvering through particularly narrow portions of the patient's vasculature, such as the iliac artery.

[0172] The balloon 650 can be fixed to the balloon catheter 652 at its balloon proximal end and can be fixed to either the balloon catheter 652 or the nose cone 640 at its distal end. The distal end portion of the push shaft 620 is positioned proximal to the outflow end (e.g., outflow ends 520, 720, 820, 920, 1020, and 1120) of the prosthetic valve 660.

[0173] Upon reaching the implantation site, prior to balloon inflation, the push shaft 620 is advanced distally such that its distal end portion contacts and pushes against the outflow end of the prosthetic valve 660, thereby enabling it to push the valve 660 distally as well. The distal end of the push shaft 620 is sized to engage the outflow end portion of the prosthetic valve 660 in its crimped configuration. In some implementations, the distal end portion of the push shaft 620 can be flared radially outward and terminate at a wider diameter that can contact the prosthetic valve 660 in its crimped state. Thereafter, the push shaft 620 can be advanced distally such that the crimped prosthetic valve 660 is positioned around the balloon 650, at which point the balloon 650 can be inflated to expand the prosthetic valve 660 radially and push the prosthetic valve 660 along with it until the prosthetic valve 660 is expanded to its functional diameter within the native valve annulus. 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 withdrawn from the patient's body.

[0174] In some embodiments, the delivery device 300 or 600 with the prosthetic valve 360 or 660 respectively assembled thereon can be packaged within a sterile package that can be supplied to an end user for storage and final use. In some embodiments, the valve leaflets of the prosthetic valve (typically made from bovine pericardial tissue, or other natural tissue, or synthetic tissue) are processed during the manufacturing process to be completely or substantially dehydrated, whereby they can be stored in a partially compressed or fully compressed state without a moisturizing liquid. In this way, the package containing the prosthetic valve 360 or 660 and the delivery device 300 or 600 can be made to contain no liquid. Methods for treating tissue valve leaflets for dry storage are disclosed in U.S. Patent No. 8,007,992 and U.S. Patent No. 8,357,387, both of which are incorporated herein by reference.

[0175] Some embodiments of the disclosed technology Some embodiments related to the above-described technology are listed below. It should be noted that one or more features of one isolated embodiment, or a combination thereof, and optionally a combination of one or more features of one or more additional embodiments, are also further embodiments that fall within the disclosure of this application.

[0176] Example 1. A prosthetic valve, comprising an annular frame movable between a compressed diameter in a radially compressed state and a deployed diameter in a radially expanded state, the frame comprising a plurality of intersecting angled struts and a plurality of vertical struts, each vertical strut extending between a vertical strut inflow end opposite to a vertical strut outflow end, the plurality of vertical struts comprising a plurality of interconnecting struts, each interconnecting strut including an interconnecting window, and a plurality of non-interconnecting vertical struts, each non-interconnecting vertical strut lacking an interconnecting window, the plurality of intersecting angled struts and the plurality of vertical struts including A frame including at least one externally formed information indicator formed along at least one of the vertical struts A valve structure installed within the frame and having a plurality of valve tips configured to regulate the flow through the artificial valve Two of the angled struts intersect each vertical strut inlet end, and another two of the angled struts intersect each vertical strut outlet end An artificial valve in which the width of the externally formed information indicator is at least as large as the width of the vertical strut along which it is formed

[0177] Example 2. The artificial valve according to any example herein, particularly Example 1, wherein the externally formed information indicator extends from at least one vertical strut inlet end of the cross-connected struts

[0178] Example 3. The artificial valve according to any example herein, particularly Example 1, wherein the externally formed information indicator extends from at least one vertical strut outlet end of the cross-connected struts

[0179] Example 4. The artificial valve according to any example herein, particularly Example 1, wherein at least one externally formed information indicator includes at least two externally formed information indicators, one of which extends from at least one vertical strut inlet end of the cross-connected struts and the other of which extends from the vertical strut outlet end of the same cross-connected strut

[0180] Example 5. The artificial valve according to any example herein, particularly any one of Examples 2 to 4, wherein at least one externally formed information indicator includes a plurality of externally formed information indicators formed along a plurality of cross-connected struts

[0181] Example 6. The artificial valve according to any example herein, particularly any one of Examples 1 to 5, wherein the externally formed information indicator extends from at least one vertical strut inlet end of the non-cross-connected vertical struts

[0182] Example 7. An artificial valve according to any one of the embodiments herein, particularly any one of Embodiments 1 to 5, wherein an information indicator formed externally extends from at least one vertical support outflow end of the non-connected vertical supports.

[0183] Example 8. An artificial valve according to any one of the embodiments herein, particularly any one of Embodiments 1 to 5, wherein at least one information indicator formed externally includes at least two information indicators formed externally, one of which extends from at least one vertical support inflow end of the non-connected vertical supports, and the other extends from the vertical support outflow end of the same non-connected vertical support.

[0184] Example 9. An artificial valve according to any one of the embodiments herein, particularly any one of Embodiments 6 to 8, wherein at least one information indicator formed externally includes a plurality of information indicators formed externally along a plurality of non-connected vertical supports.

[0185] Example 10. An artificial valve according to any one of the embodiments herein, particularly any one of Embodiments 1 to 9, wherein the width of the information indicator formed externally is greater than the width of the vertical support along which it is formed.

[0186] Example 11. An artificial valve according to any one of the embodiments herein, particularly the artificial valve according to Example 7, wherein the width of the information indicator formed externally is greater than the width of the non-connected vertical support on which it is formed.

[0187] Example 12. An artificial valve according to any one of the embodiments herein, particularly the artificial valve according to Example 11, wherein the difference between the width of the information indicator formed externally and the width of the non-connected vertical support is at least as large as the thickness of the valve tip.

[0188] Example 13. An artificial valve according to any one of the embodiments herein, particularly the artificial valve according to Example 11, wherein the difference between the width of the information indicator formed externally and the width of the non-connected vertical support is at least as large as twice the thickness of the valve tip.

[0189] Example 14. An artificial valve according to any example herein, particularly Example 11, in which the difference between the width of the externally formed information indicator and the width of the non-connected vertical strut is at least as large as four times the thickness of the valve tip.

[0190] Example 15. An artificial valve according to any example described herein, particularly Example 1 to 14, in which at least one externally formed information indicator includes a plurality of externally formed information indicators, at least two of which have different shapes from each other.

[0191] Example 16. An artificial valve according to any example herein, particularly Example 15, in which at least one of the externally formed information indicators is in the shape of a character and the other of the externally formed information indicators is in the shape of an Arabic numeral.

[0192] Example 17. An artificial valve according to any example herein, particularly Example 1 to 17, in which the frame further includes at least two support struts that extend between at least two adjacent vertical struts and intersect each other at the support tips, and at least one support strut extends from at least one externally formed information indicator.

[0193] Example 18. An artificial valve according to any example herein, particularly Example 17, in which at least one externally formed information indicator includes an inflow portion that coincides with the vertical strut inflow end, an outflow portion on the opposite side, and a central portion disposed therebetween, and the central portion is in the form of a laterally oriented extension.

[0194] Example 19. An artificial valve according to any example herein, particularly Example 18, in which the support strut extending from the externally formed information indicator extends from its central portion.

[0195] Example 20. An artificial valve according to any example herein, particularly Example 18, in which the support strut extending from the externally formed information indicator extends from its outflow portion.

[0196] Example 21. An artificial valve according to any example herein, particularly any one of Examples 17 to 20, wherein at least one of the vertical struts from which the support struts extend is a non-connected vertical strut further comprising a lateral extension from which the corresponding support strut extends.

[0197] Example 22. An artificial valve according to any example herein, particularly any one of Examples 17 to 21, wherein the width of each support strut is smaller than the width of any of the angled strut portions.

[0198] Example 23. An artificial valve according to any example herein, particularly any one of Examples 17 to 22, wherein the support struts include two support struts extending between each two adjacent vertical struts.

[0199] Example 24. An artificial valve according to any example herein, particularly any one of Examples 17 to 23, further comprising an outer skirt disposed around the frame and attached to the support struts.

[0200] Example 25. An artificial valve according to any example herein, particularly any one of Examples 1 to 16, wherein at least one externally formed information indicator comprises an inflow portion connected to two of the angled struts, an outflow portion on the opposite side, and a central portion disposed therebetween, the central portion comprising a lateral body extending laterally and terminating in a bi-directional vertical extension, and forming two shoulders at the transition between the lateral body and the bi-directional vertical extension.

[0201] Example 26. An artificial valve according to any example herein, particularly any one of Examples 1 to 16, wherein the inflow portion of the externally formed information indicator extends from the vertical strut outflow end of one of the non-connected vertical struts adjacent to one of the cross-connected struts such that the inflow portion of the externally formed information indicator is axially distal to the outflow edge of the cross-connecting window.

[0202] Example 27. An artificial valve according to any example herein, particularly the artificial valve described in Example 26, wherein the axial distance between the inflow portion of the externally formed information indicator and the outflow edge of the communication window is smaller than the difference between the axial height of the artificial valve in the radially compressed state and the axial height of the artificial valve in the radially expanded state.

[0203] Example 28. An artificial valve according to any example herein, particularly any one of Examples 1 to 27, wherein at least one externally formed information indicator is made of a radiation-impermeable material.

[0204] Example 29. An artificial valve according to any example herein, particularly any one of Examples 1 to 28, wherein at least one externally formed information indicator indicates the manufacturer of the artificial valve.

[0205] Example 30. An artificial valve according to any example herein, particularly any one of Examples 1 to 29, wherein at least one externally formed information indicator indicates the model of the artificial valve.

[0206] Example 31. An artificial valve according to any example herein, particularly any one of Examples 1 to 30, wherein at least one externally formed information indicator indicates the deployment diameter of the artificial valve.

[0207] Example 32. An artificial valve according to any example herein, particularly any one of Examples 1 to 30, wherein 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, the first externally formed information indicator indicates the first digit of the deployment diameter of the artificial valve, and the second externally formed information indicator indicates the second digit of the deployment diameter of the artificial valve.

[0208] Example 33. An artificial valve, An annular frame movable between a compressed diameter in a radially compressed state and a deployed diameter in a radially expanded state, the frame comprising: a plurality of actuating posts including an upper post member and a lower post member; a plurality of support posts, each support post extending between a post inlet end and a post inlet end on the opposite side of the post inlet end, the plurality of support posts comprising: a plurality of cross-linked support posts, each cross-linked support post including a cross-linking window; a plurality of non-cross-linked support posts, each non-cross-linked support post lacking a cross-linking window; a plurality of curved struts extending circumferentially between adjacent actuating posts and support posts and interconnecting the actuating posts and support posts; a plurality of actuators coupled to the actuating posts and configured to adjust the frame between a radially compressed state and a radially expanded state; at least one information indicator formed in or along at least one of the support posts; a valve structure comprising a plurality of valve tips installed within the frame and configured to regulate flow through the artificial valve; two of the curved struts intersect each post inlet end, and another two of the curved struts intersect each vertical strut outlet end; An artificial valve, wherein each support post intersects at least eight curved struts extending from adjacent actuating posts.

[0209] Example 34. The artificial valve according to any example of this specification, particularly Example 33, wherein the information indicator is an information indicator formed internally.

[0210] Example 35. The artificial valve according to any example of this specification, particularly Example 34, wherein the width of each support post is greater than the width of any of the curved struts.

[0211] Example 36. An artificial valve according to any example herein, particularly the artificial valve described in Example 34 or Example 35, wherein the width of the support post is greater than the width of the information indicator formed therein.

[0212] Example 37. An artificial valve according to any example herein, particularly any one of Examples 34 to 36, wherein at least one information indicator formed therein is formed in at least one of the non-connected support posts.

[0213] Example 38. An artificial valve according to any example herein, particularly any one of Examples 34 to 37, wherein at least one information indicator formed therein includes at least two information indicators formed therein, both of which are formed at different axial positions of at least one of the non-connected support posts.

[0214] Example 39. An artificial valve according to any example herein, particularly the artificial valve described in Example 38, wherein at least two of the information indicators formed therein are formed differently.

[0215] Example 40. An artificial valve according to any example herein, particularly any one of Examples 34 to 37, wherein at least one information indicator formed therein includes a plurality of information indicators formed in a plurality of non-connected support posts.

[0216] Example 41. An artificial valve according to any example herein, particularly the artificial valve described in Example 40, wherein at least two of the plurality of information indicators formed therein are formed differently.

[0217] Example 42. An artificial valve according to any example herein, particularly any one of Examples 34 to 36, wherein at least one information indicator formed therein is formed in at least one of the connected support posts.

[0218] Example 43. An artificial valve according to any example herein, particularly Example 42, wherein at least one internally formed information indicator is distal to the crosslinked support post.

[0219] Example 44. An artificial valve according to any example herein, particularly Example 42 or Example 43, wherein 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 crosslinked support posts.

[0220] Example 45. An artificial valve according to any example herein, particularly Example 42, wherein at least two of the internally formed information indicators are formed differently.

[0221] Example 46. An artificial valve according to any example herein, particularly any one of Examples 42 - 45, wherein at least one internally formed information indicator includes a plurality of internally formed information indicators formed on a plurality of crosslinked support posts.

[0222] Example 47. An artificial valve according to any example herein, particularly Example 46, wherein at least two of the plurality of internally formed information indicators are formed differently.

[0223] Example 48. An artificial valve according to any example herein, particularly Example 33, wherein the information indicator is an externally formed information indicator.

[0224] Example 49. An artificial valve according to 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 it is formed.

[0225] Example 50. An artificial valve according to any example herein, particularly Example 48 or Example 49, wherein the width of each of the support posts is greater than the width of any of the curved struts.

[0226] Example 51. An artificial valve according to any one of the embodiments herein, particularly any one of Embodiments 48 to 50, wherein an externally formed information indicator extends from the inflow end of at least one of the cross-linked support posts.

[0227] Example 52. An artificial valve according to any one of the embodiments herein, particularly any one of Embodiments 48 to 50, wherein an externally formed information indicator extends from the outflow end of at least one of the cross-linked support posts.

[0228] Example 53. An artificial valve according to any one of the embodiments herein, particularly any one of Embodiments 48 to 50, wherein at least one externally formed information indicator includes at least two externally formed information indicators, one of which extends from the inflow end of at least one of the cross-linked support posts and the other of which extends from the outflow end of the same cross-linked support post.

[0229] Example 54. An artificial valve according to any one of the embodiments herein, particularly any one of Embodiments 51 to 53, wherein at least one externally formed information indicator includes a plurality of externally formed information indicators formed along a plurality of cross-linked support posts.

[0230] Example 55. An artificial valve according to any one of the embodiments herein, particularly any one of Embodiments 48 to 54, wherein an externally formed information indicator extends from the inflow end of at least one of the non-cross-linked support posts.

[0231] Example 56. An artificial valve according to any one of the embodiments herein, particularly any one of Embodiments 48 to 54, wherein an externally formed information indicator extends from the outflow end of at least one of the non-cross-linked support posts.

[0232] Example 57. An artificial valve according to any example herein, particularly any one of Examples 48 to 54, wherein at least one externally formed information indicator includes at least two externally formed information indicators, one of which extends from at least one post inlet end of the non-connected support posts and the other of which extends from the post outlet end of the same non-connected support post.

[0233] Example 58. An artificial valve according to any example herein, particularly any one of Examples 55 to 57, wherein at least one externally formed information indicator includes a plurality of externally formed information indicators formed along a plurality of non-connected support posts.

[0234] Example 59. An artificial valve according to any example herein, particularly any one of Examples 49 to 58, wherein at least one externally formed information indicator includes a plurality of externally formed information indicators, at least two of which have different shapes from each other.

[0235] Example 60. An artificial valve according to any example herein, particularly Example 48 or Example 59, wherein at least one of the externally formed information indicators is in the shape of a character and the other of the externally formed information indicators is in the shape of an Arabic numeral.

[0236] Example 61. An artificial valve according to any example herein, particularly any one of Examples 49 to 60, wherein at least one externally formed information indicator includes an inlet portion connected to two of the curved struts, an outlet portion on the opposite side, and a central portion disposed therebetween, the central portion comprising a lateral body that extends laterally and terminates in a bi-directional vertical extension, and two shoulders are formed at the transition between the lateral body and the bi-directional vertical extension.

[0237] Example 62. An artificial valve according to any example herein, particularly any one of Examples 49 to 61, wherein at least one externally formed information indicator is made of a radiopaque material.

[0238] Example 63. An artificial valve according to any one of the examples herein, particularly any one of Examples 49 to 62, wherein at least one externally formed information indicator indicates the manufacturer of the artificial valve.

[0239] Example 64. An artificial valve according to any one of the examples herein, particularly any one of Examples 49 to 63, wherein at least one externally formed information indicator indicates the model of the artificial valve.

[0240] Example 65. An artificial valve according to any one of the examples herein, particularly any one of Examples 49 to 64, wherein at least one externally formed information indicator indicates the deployed diameter of the artificial valve.

[0241] Example 66. An artificial valve according to any one of the examples herein, particularly any one of Examples 33 to 65, wherein at least one information indicator includes a first information indicator in one of the support posts and a second information indicator in an adjacent support post, the first information indicator indicating the first digit of the deployed diameter of the artificial valve, and the second information indicator indicating the second digit of the deployed diameter of the artificial valve.

[0242] It is understood that certain features of the invention described in the context of separate examples can be provided in combination in a single example for clarity. Conversely, although the various features of the present disclosure are described in the context of a single example for brevity, they may be provided individually, or in any suitable sub-combination, or in any other suitable example of the present disclosure. Any feature described in the context of an example should not be considered an essential feature of that example unless explicitly so designated.

[0243] Considering the many possible examples to which the principles of the present disclosure may be applied, it will be recognized that the illustrated examples are merely preferred examples and should not be regarded as limiting the scope of the present disclosure. Rather, the scope of the present disclosure is defined by the following claims. Accordingly, all that is included within the scope and spirit of those claims is claimed.

Claims

**Claim 1** An artificial valve, comprising: An annular frame movable between a compressed diameter in a radially compressed state and an expanded diameter in a radially expanded state, said frame comprising: A plurality of intersecting angled struts and a plurality of vertical struts, each vertical strut extending between a vertical strut inlet end and a vertical strut outlet end opposite the vertical strut inlet end, the plurality of vertical struts comprising: A plurality of interconnected struts, each interconnected strut including an interconnect window; and A plurality of non-connected vertical struts, each non-connected vertical strut lacking an interconnect window, the plurality of intersecting angled struts and the plurality of vertical struts including: At least one externally formed information indicator formed along at least one of said vertical struts; and A valve structure comprising a plurality of valve tips installed within said frame and configured to regulate flow through said artificial valve; Two of the angled struts intersect each vertical strut inlet end, and two other of the angled struts intersect each vertical strut outlet end; An artificial valve, wherein the width of the externally formed information indicator is at least as large as the width of the vertical strut along which it is formed. **Claim 2** The artificial valve according to claim 1, wherein the externally formed information indicator extends from the vertical strut inlet end of at least one of said interconnected struts. **Claim 3** The artificial valve according to claim 1, wherein the externally formed information indicator extends from the vertical strut outlet end of at least one of said interconnected struts. **Claim 4** The artificial valve according to claim 1, wherein the at least one externally formed information indicator includes at least two externally formed information indicators, one of which extends from the vertical strut inlet end of at least one of said interconnected struts and the other of which extends from the vertical strut outlet end of the same interconnected strut. **Claim 5** The artificial valve according to 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 it is formed. **Claim 6** The artificial valve according to any one of claims 1 to 5, wherein the at least one externally formed information indicator includes a plurality of externally formed information indicators, at least two of which have different shapes. **Claim 7** The artificial valve according to claim 6, wherein at least one of the information indicators formed on the outside is in the shape of a character, and the other of the information indicators formed on the outside is in the shape of an Arabic numeral.

8. The artificial valve according to any one of claims 1 to 7, wherein the frame further comprises at least two support struts that extend between at least two adjacent vertical struts and intersect each other at support tips, and at least one support strut extends from at least one of the information indicators formed on the outside.

9. The artificial valve according to claim 8, wherein the at least one information indicator formed on the outside comprises an inflow portion that coincides with the vertical strut inflow end, an outflow portion on the opposite side, and a central portion disposed therebetween, and the central portion is in the form of a laterally oriented extension.

10. The artificial valve according to any one of claims 1 to 9, wherein the at least one information indicator formed on the outside comprises an inflow portion connected to two of the angled struts, an outflow portion on the opposite side, and a central portion disposed therebetween, the central portion comprising a lateral body that extends laterally and terminates in a bi-directional vertical extension, and two shoulders are formed at the transition between the lateral body and the bi-directional vertical extension.

11. The artificial valve according to any one of claims 1 to 10, wherein the at least one information indicator formed on the outside extends from the vertical strut outflow end of one of the non-connected vertical struts adjacent to one of the cross-linking struts such that the inflow portion of the information indicator formed on the outside is axially distal to the outflow edge of the cross-linking window.

12. The artificial valve according to claim 11, wherein the axial distance between the inflow portion of the information indicator formed on the outside and the outflow edge of the cross-linking window is smaller than the difference between the axial height of the artificial valve in the radially compressed state and the axial height of the artificial valve in the radially expanded state.

13. 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, the first externally formed information indicator indicating the first digit of the deployment diameter of the artificial valve, and the second externally formed information indicator indicating the second digit of the deployment diameter of the artificial valve. The artificial valve according to any one of claims 1 to 12.

14. An artificial valve, An annular frame movable between a compressed diameter in a radially compressed state and a deployed diameter in a radially expanded state, the frame including A plurality of actuating posts including an upper post member and a lower post member, A plurality of support posts, each support post extending between a post inlet end and an opposite post inlet end, the plurality of support posts including A plurality of interconnected support posts, each interconnected support post including an interconnect window, A plurality of non-interconnected support posts, each non-interconnected support post lacking an interconnect window, the plurality of support posts including A plurality of curved struts extending circumferentially between adjacent actuating posts and support posts and interconnecting the actuating posts and the support posts, A plurality of actuators coupled to the actuating posts and configured to adjust the frame between the radially compressed state and the radially expanded state, A frame including at least one information indicator formed in or along at least one of the support posts, A valve structure including a plurality of valve tips installed within the frame and configured to regulate the flow through the artificial valve. Two of the curved struts intersect each post inlet end, and another two of the curved struts intersect each post outlet end. An artificial valve, wherein each support post intersects at least eight curved struts extending from an adjacent actuating post.

15. The artificial valve according to claim 14, wherein the information indicator is an internally formed information indicator.

16. The artificial valve according to claim 15, wherein the width of the support post is greater than the width of the internally formed information indicator formed therein.

17. The at least one information indicator formed inside includes at least two information indicators formed inside, and both of them are formed at at least one different axial position of the non-connected support posts. The artificial valve according to any one of claims 14 to 16.

18. The artificial valve according to claim 14, wherein the information indicator is an information indicator formed outside.

19. The artificial valve according to claim 18, wherein the width of the information indicator formed outside is larger than the width of the support post along which it is formed.

20. The at least one information indicator includes a first information indicator in one of the support posts and a second information indicator in an adjacent support post, the first information indicator indicating the first digit of the deployed diameter of the artificial valve, and the second information indicator indicating the second digit of the deployed diameter of the artificial valve. The artificial valve according to any one of claims 14 to 19.

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