Transcatheter prosthetic heart valve with radiopaque markers

Abstract

A prosthetic heart valve includes a frame, a valve component disposed within and coupled to the frame, a radiopaque marker, wherein the radiopaque marker is formed from a radiopaque polyurethane tape.

Description

TRANSCATHETER PROSTHETIC HEART VALVE WITHRADIOPAQUE MARKERSCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 636,488, filed April 19, 2024, the entire content of which is incorporated herein by reference.FIELD

[0002] The present disclosure is related to heart valve prostheses with radiopaque markers.BACKGROUND

[0003] The human heart is a four chambered, muscular organ that provides blood circulation through the body during a cardiac cycle. The four chambers include the right atrium and the right ventricle, which supplies the pulmonary circulation, and the left atrium and the left ventricle which supplies oxygenated blood received from the lungs into systemic circulation. To ensure that blood flows in one direction through the heart, atrioventricular valves (tricuspid and mitral valves) are present between the junctions of the atrium and the ventricles, and semi-lunar valves (pulmonary valve and aortic valve) govern the exits of the ventricles leading to the lungs and the rest of the body. These valves contain leaflets or cusps that open and shut in response to blood pressure changes caused by the contraction and relaxation of the heart chambers. The valve leaflets move apart from each other to open and allow blood to flow downstream of the valve, and coapt to close and prevent backflow or regurgitation in an upstream manner.

[0004] Patients suffering from various medical conditions or diseases may require surgery to install an implantable medical device. For example, valve regurgitation or stenotic calcification of leaflets of a heart valve may be treated with a heart valve replacement procedure. A traditional surgical valve replacement procedure requires a sternotomy and a cardiopulmonary bypass, which creates significant patient trauma anddiscomfort. Traditional surgical valve procedures may also require extensive recuperation times and may result in life-threatening complications.

[0005] One alternative to a traditional surgical valve replacement procedure is delivering implantable medical devices using minimally invasive techniques. For example, a prosthetic heart valve can be percutaneously and transluminally delivered and deployed at the site of the diseased heart valve through catheter-based delivery systems. Such heart valve prostheses can be delivered while in a low-profde or compressed configuration so that the prosthetic heart valve can be advanced through the patient’s vasculature. Once positioned at the treatment site, the prosthetic heart valve can be expanded to engage tissue at the diseased heart valve region to, for instance, hold the prosthetic heart valve in position.

[0006] For example, transcatheter aortic valve implantation (TAVI) is used to implant a transcatheter aortic valve (TAV) at the location of a native aortic valve. During the TAVI procedure, it is critical for the TAV to be properly positioned within the native aortic valve. For example, and not by way of limitation, depth and rotational orientation or alignment of the implanted prosthetic heart valve is crucial. If the TAV is implanted too high, the TAV may migrate distally, or in a downstream direction towards the aorta. If it is implanted too low, the TAV may cause conductance disturbances, leading to additional treatment requirements. If the TAV is not rotationally oriented with the native commissures, paths to the coronary arteries may be obstructed and prevent access for future interventions.

[0007] Accordingly, there is a need in the art for improved devices to improve and to optimize anatomical orientation or alignment of a transcatheter prosthetic heart valve within a native heart valve.BRIEF SUMMARY

[0008] In an example of the present application, a prosthetic heart valve configured to radially expand from a radially compressed configuration to a radially expanded configuration comprises: a frame; a valve component disposed within and coupled to the frame; and a radiopaque marker, wherein the radiopaque marker is formed from a radiopaque polyurethane tape.

[0009] In another example hereof, in the prosthetic heart valve of any of the preceding or following examples, the radiopaque marker comprises a base, a first leg extending from the base, and a second leg extending from the base.

[0010] In another example hereof, in the prosthetic heart valve of any of the preceding or following examples, the base of the radiopaque marker is disposed on a crown of the frame at an inflow end of the frame, the first leg extends distally from the base along a first strut extending from the crown towards a first node of a first node row spaced from the inflow end of the frame, and the second leg extends distally from the base along a second strut extending from the crown towards a second node of the first node row.

[0011] In another example hereof, in the prosthetic heart valve of any of the preceding or following examples, the radiopaque marker is substantially V-shaped with the prosthetic heart valve in the radially expanded configuration.

[0012] In another example hereof, in the prosthetic heart valve of any of the preceding or following examples, the base of the radiopaque marker is disposed on a node of a first node row of the frame spaced from an inflow end of the frame, the first leg extends proximally from the base along a first strut extending from the node towards a first crown of a first crown row at the inflow end of the frame; and the second leg extends proximally from the base along a second strut extending from the node towards a second crown of the first crown row.

[0013] In another example hereof, in the prosthetic heart valve of any of the preceding or following examples, the radiopaque marker is substantially an inverted V-shape with the prosthetic heart valve in the radially expanded configuration.

[0014] In another example hereof, in the prosthetic heart valve of any of the preceding or following examples, valve component comprises a plurality of leaflets with adjacent leaflets coupled to each other at commissures, and wherein the radiopaque marker is substantially axially aligned with a commissure of the commissures.

[0015] In another example hereof, in the prosthetic heart valve of any of the preceding or following examples, a first leg end of the first leg opposite the base and a second leg end of the second leg opposite the base are configured to be longitudinally aligned with an annulus of the native heart valve.

[0016] In another example hereof, in the prosthetic heart valve of any of the preceding or following examples, the first leg end and the second leg end are disposed a first height from the proximal end of the frame, wherein the first height is between about 2 mm and about 5 mm, or about 2.4 mm and about 4.6 mm, or about 2.6 mm and about 3.0 mm.

[0017] In another example hereof, in the prosthetic heart valve of any of the preceding or following examples, the radiopaque marker includes a first radiopaque marker and a second radiopaque marker, wherein the first radiopaque marker is V-shaped and the second radiopaque marker is an inverted V-shape, wherein the second radiopaque marker is circumferentially and longitudinally spaced from the first radiopaque marker.

[0018] In another example hereof, in the prosthetic heart valve of any of the preceding or following examples, the first radiopaque marker is substantially axially aligned with a first commissure of a plurality of commissures of the valve component and the second radiopaque marker is substantially axially aligned with a second commissure of the plurality of commissures of the valve component.

[0019] In another example hereof, in the prosthetic heart valve of any of the preceding or following examples: the first radiopaque marker includes a base disposed at a first crown at an inflow end of the frame, a first leg extending distally from the base along a first strut towards a first node of a first node row spaced from the inflow end, and a second leg extending distally from the base along a second strut towards a second node of the first node row; and the second radiopaque marker includes a base disposed at a third node of the first node row, a first leg extending proximally from the base along a third strut towards a second crown at the inflow end of the frame, and a second leg extending proximally from the base along a fourth strut towards a third crown at the inflow end.

[0020] In another example hereof, in the prosthetic heart valve of any of the preceding or following examples, corresponding distal ends of the first and second legs of the first radiopaque marker and corresponding proximal ends of the first and second legs of the second radiopaque marker terminate at a position between the inflow end of the frame and the first node row.

[0021] In another example hereof, in the prosthetic heart valve of any of the preceding or following examples, the position is between about 2 mm and about 5 mm, or about 2.4mm and about 4.6 mm, or about 2.6 mm and about 3.0 mm from the inflow end of the frame.

[0022] In another example hereof, in the prosthetic heart valve of any of the preceding or following examples, the heart valve prosthesis is configured such that when viewed in a fluoroscopic image, the heart valve prosthesis is properly rotationally aligned when the first radiopaque marker and the second radiopaque marker form a substantially diamond shape.

[0023] In another example hereof, in the prosthetic heart valve of any of the preceding or following examples, the prosthetic heart valve is configured to be deployed at a site of a native aortic heart valve, and wherein the radiopaque markers are configured to rotationally orient the prosthetic heart valve to avoid blocking ostia of the coronary arteries.

[0024] In another example hereof, in the prosthetic heart valve of any of the preceding or following examples, the radiopaque marker is coupled to the prosthetic heart valve with sutures.

[0025] In another example of the present application, a prosthetic heart valve configured to radially expand from a radially compressed configuration to a radially expanded configuration comprises: a frame; a valve component disposed within and coupled to the frame; and a radiopaque marker, wherein the radiopaque marker is a gold coating.

[0026] In another example hereof, in the prosthetic heart valve of any of the preceding or following examples, the radiopaque marker comprises a first leg extending from a crown at the inflow end of the frame along a first strut extending distally from the crown, and a second leg extending from the crown along a second strut adjacent the first strut and extending from the first crown.

[0027] In another example hereof, in the prosthetic heart valve of any of the preceding or following examples, the radiopaque marker comprises a first leg extending from a node of a first node row spaced from the inflow end of the frame along a first strut extending proximally from the node, and a second leg extending from the first node along a second strut adjacent the first strut and extending proximally from the first node.

[0028] In another example hereof, in the prosthetic heart valve of any of the preceding or following examples, the radiopaque marker is substantially axially aligned with a commissure of the valve component.

[0029] In another example hereof, in the prosthetic heart valve of any of the preceding or following examples, the radiopaque marker includes a first radiopaque marker and a second radiopaque marker, wherein the first radiopaque marker comprises two legs of a V- shape and the second radiopaque marker comprises two legs of an inverted V-shape, wherein the second radiopaque marker is circumferentially and longitudinally spaced from the first radiopaque marker.

[0030] In another example hereof, in the prosthetic heart valve of any of the preceding or following examples, the first radiopaque marker is substantially axially aligned with a first commissure of a plurality of commissures of the valve component and the second radiopaque marker is substantially axially aligned with a second commissure of the plurality of commissures of the valve component.

[0031] In another example hereof, in the prosthetic heart valve of any of the preceding or following examples, the prosthetic heart valve is configured such that when viewed in a fluoroscopic image, the prosthetic heart valve is properly rotationally aligned when the first radiopaque marker and the second radiopaque marker form a substantially diamond shape.

[0032] In another example hereof, in the prosthetic heart valve of any of the preceding or following examples, the prosthetic heart valve is configured to be deployed at a site of a native aortic heart valve, and wherein the radiopaque markers are configured to rotationally orient the prosthetic heart valve to avoid blocking ostia of the coronary arteries.

[0033] The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the techniques described in this disclosure will be apparent from the description and drawings, and from the claims.BRIEF DESCRIPTION OF DRAWINGS

[0034] The foregoing and other features and advantages of the present disclosure will be apparent from the following description of embodiments hereof as illustrated in theaccompanying drawings. The accompanying drawings, which are incorporated herein and form a part of the specification, further serve to explain the principles of the present disclosure and to enable a person skilled in the pertinent art to make and use the embodiments of the present disclosure. The drawings may not be to scale.

[0035] FIG. 1 depicts an illustration of a prosthetic heart valve according to embodiments hereof.

[0036] FIG. 2 depicts a plan view illustration of the prosthetic heart valve of FIG. 1 viewed from an outflow end.

[0037] FIG. 3 depicts a close-up, side view illustration of a V-shaped radiopaque marker of the prosthetic heart valve of FIG. 1, according to embodiments hereof.

[0038] FIG. 4 depicts an illustration of the V-shaped radiopaque marker of FIG. 3, according to embodiments hereof.

[0039] FIG. 5 depicts a V-shaped radiopaque marker including patterned stitching according to embodiments hereof.

[0040] FIG. 6 depicts an illustration of a pattern for forming the V-shaped radiopaque marker of FIG. 4 on a sheet of radiopaque tape material, according to embodiments hereof.

[0041] FIG. 7 depicts a close-up view of a portion of the sheet of FIG. 6.

[0042] FIGS. 8A-8B depict illustrations of the prosthetic heart valve of FIG. 1 in situ, within a native aortic valve.

[0043] FIG. 8C depicts an illustration of a native aortic valve viewed from the aorta, showing a cusp overlap viewing angle.

[0044] FIG. 8D depicts an illustration of a fluoroscopic image of a native aortic valve utilizing a cusp overlap viewing angle showing the markers of the heart valve prosthesis of FIG. 1.

[0045] FIG. 9 depicts an illustration of a prosthetic heart valve according to embodiments hereof.

[0046] FIG. 10 depicts a close-up, side view illustration of an inverted V-shaped radiopaque marker of the prosthetic heart valve of FIG. 9, according to embodiments hereof.

[0047] FIG. 11 depicts an illustration of the inverted V-shaped radiopaque marker of FIG. 10, according to an embodiment hereof.

[0048] FIG. 12A depicts an illustration of a native aortic valve viewed from the aorta, showing a cusp overlap view angle.

[0049] FIG. 12B depicts an illustration of a fluoroscopic image of a native aortic valve utilizing a cusp overlap viewing angle showing the markers of the heart valve prosthesis of FIG. 9.

[0050] FIG. 13 depicts an illustration of a prosthetic heart valve according to embodiments hereof.

[0051] FIG. 14 depicts an illustration of the frame and the radiopaque markers of the prosthetic heart valve of FIG. 13 in a cut, laid flat view.

[0052] FIG. 15 depicts a close-up illustration of first and second radiopaque markers of the prosthetic heart valve of FIG. 13.

[0053] FIG. 16A depicts an illustration of a native aortic valve viewed from the aorta, showing a cusp overlap view angle.

[0054] FIG. 16B depicts an illustration of a fluoroscopic image of a native aortic valve utilizing a cusp overlap viewing angle showing the markers of the heart valve prosthesis of FIG. 13

[0055] FIG. 17 depicts an illustration of a prosthetic heart valve according to embodiments hereof.

[0056] FIG. 18 depicts an illustration of a prosthetic heart valve according to embodiments hereof.

[0057] FIG. 19A depicts an illustration of a prosthetic heart valve according to embodiments hereof.

[0058] FIG. 19B depicts an illustration of the frame and the radiopaque markers of the prosthetic heart valve of FIG. 19A in a cut, laid flat view.DETAILED DESCRIPTION

[0059] It should be understood that various embodiments disclosed herein may be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. It should also be understood that, depending on the example, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, may be added, merged, or left out altogether (e.g., all described acts or events may not be necessary to carry out the techniques). Inaddition, while certain aspects of this disclosure are described as being performed by a single device or component for purposes of clarity, it should be understood that the techniques of this disclosure may be performed by a combination of devices or components associated with, for example, a delivery system. The following detailed description is merely exemplary in nature and is not intended to limit the disclosure and embodiments hereof. Furthermore, there is no intention to be bound by any expressed or implied theory presented in the preceding field, background, summary, or the following detailed description.

[0060] As used in this specification, the singular forms “a,” “an” and “the” specifically also encompass the plural forms of the terms to which they refer, unless the content clearly dictates otherwise. Further, numerical terms such as “first”, “second”, “third”, etc. used herein are not meant to be limiting such that use of the term “second” when referring to a part in the specification does not mean that there necessarily is a “first” part in order to fall within the scope of the disclosure. Instead, such numbers are merely describing that the particular embodiment being described has a “first” part and a “second” part. The disclosure is instead defined by the claims, in which one or more of the numbered parts may be claimed.

[0061] The terms, “distal” and “proximal”, when used in the following description, to refer to a native vessel, native valve, or a device to be implanted into a native vessel, or native valve, such as a prosthetic heart valve, are with reference to the direction of blood flow. Thus, “distal” and “distally”, refer to positions in a downstream direction with respect to the direction of blood flow, and the terms “proximal” and “proximally”, refer to positions in an upstream direction with respect to the direction of blood flow.

[0062] The term “open end” and the term “closed end” when used in the following description to refer to V-shapes of radiopaque markers are with respect to the two legs of each V-shaped radiopaque marker. Each V-shaped radiopaque marker will include a “closed end” referring to the end of the V-shape where the two legs of the radiopaque marker converge, and an “open end” referring to the end of the V-shaped where the two legs of the radiopaque marker diverge.

[0063] Embodiments herein relate to radiopaque markers disposed on a prosthetic heart valve and configured for improved longitudinal and rotational orientation oralignment of the prosthetic heart valve with a native heart valve. In embodiments herein, the radiopaque markers provide a stark, strong, or sharp contrast against a frame of the prosthetic heart valve under fluoroscopic imaging. Accordingly, each radiopaque marker provides a treating clinician with visual indicators or cues for improved positioning of the prosthetic heart valve at the desired depth and the desired rotational orientation with the native heart valve.

[0064] FIGS. 1-5 illustrate a prosthetic heart valve 100 upon which one or more radiopaque markers 102 may be disposed, in accordance with embodiments hereof. The prosthetic heart valve 100 is illustrated herein to facilitate description of the one or more radiopaque markers 102, and is not meant to be limiting. The radiopaque markers 102 may be configured to orient the prosthetic heart valve 100 rotationally and longitudinally within a native heart valve. It is understood that the prosthetic heart valve 100 is presented by way of example only, and that the radiopaque markers and methods described herein may be used on other prosthetic heart valves. Further, the components illustrated in FIGS. 1-5 may be removed and / or additional components may be added to the prosthetic heart valve 100. Other shapes and designs of prosthetic heart valves are also consistent with embodiments hereof. Although the prosthetic heart valve 100 is configured for placement within an aortic heart valve, embodiments of radiopaque markers and techniques described herein may be used in conjunction with any transcatheter prosthetic heart valve. For example, embodiments described herein may be utilized with a prosthetic heart valve configured for placement within a pulmonary, aortic, mitral, or tricuspid valve. There is no intention of being bound by any expressed or implied theory presented in the preceding technical field, background, brief summary or the following detailed description.

[0065] FIGS. 1-5 depict a prosthetic heart valve 100 including a frame 106, a valve component (prosthetic valve) 104 disposed within and coupled to the frame 106, and at least one radiopaque marker 102 coupled to the frame 106. The prosthetic heart valve 100 is configured to be radially compressed into a reduced-diameter, or radially compressed configuration (not shown) for delivery within a vasculature and to return to a radially expanded or deployed configuration. In accordance with embodiments hereof, when in the radially compressed configuration, the prosthetic heart valve 100 has a low profile suitable for delivery to and deployment within the native heart valve via a suitable delivery device,system, or catheter. The prosthetic heart valve 100 may include various components and construction, as described in U.S. Patent Application Publication No. 2022 / 0175521 Al to Baldwin et al., which is incorporated by reference herein in its entirety.

[0066] As shown in FIG. 1, the prosthetic heart valve 100 includes the frame 106 having an inflow end 118 and an outflow end 120. The frame 106 of the prosthetic heart valve 100 includes a plurality of struts 110 that are arranged to form a plurality of cells arranged circumferentially around a longitudinal axis LA of the prosthetic heart valve 100 and longitudinally to form a tubular structure. The struts 110 are defined as the elongated wire segments of the frame 106. In the embodiment shown, the plurality of cells includes a plurality of first cells 124 and one or more access cells 126. The one or more access cells 126 each have an enlarged area relative or compared to the first cells 126. The first cells 124 and the access cells 126 are generally diamond shaped. In embodiments, the plurality of first cells 124 may vary in size within the frame 106. The frame 106 includes a plurality of crowns 122, with each crown 122 being formed between a pair of opposing struts 110. Each crown 122 may be a curved segment or bend extending between opposing struts 110. The frame 106 includes a plurality of nodes 123 defined as a region where two crowns 122 meet or connect. As shown in FIG. 2, the frame 106 includes a plurality of axial struts 112 (six in the embodiment shown), with three of the axial struts 112 being commissure posts 111. Each commissure post 111 is aligned with a commissure 114 of the valve component 104 and has a corresponding leaflet commissure 114 attached thereto. The valve component 104 is disposed within a central lumen 116 of the frame 106. The frame 106 secures the prosthetic heart valve 100 in place in situ within the vasculature of the patient. The first cells 124 and the access cells 126 are defined as the open spaces or windows formed between the plurality of struts 110, crowns 122, and / or nodes 123. The inflow end 118 of the frame 106 forms an inflow end of the prosthetic heart valve 100 and the outflow end 120 of the frame 106 forms an outflow end of the prosthetic heart valve 100.

[0067] The frame 106 of the prosthetic heart valve 100 is described herein for illustrative purposes in terms of horizontal rows of crowns 122, horizontal rows of nodes 123, and horizontal rows of struts 110. With reference to FIG. 1, an inflow crown row 136 of crowns 122, a first strut row 130 of struts 110 adjacent the inflow crown row 136, a first node row 138 of nodes 123 distally adjacent the first strut row 130, and a second strut row132 of struts 110 distally adjacent the first node row 138 such that the nodes 123 of the first node row 138 are formed wherein the first strut row 130 and the second strut row 132 adjoin each other.

[0068] The frame 106 of the prosthetic heart valve 100 may be made from any number of suitable biocompatible materials, such as, but not limited to stainless steel, nickel titanium alloys such as Nitinol™, cobalt chromium alloys such as MP35N, other alloys such as ELGILOY® (Elgin, Ill.), or any number of other materials or combination of materials. In the embodiments described herein, the frame 106 is self-expanding. However, in other embodiments, the frame 106, and hence the prosthetic heart valve 100, may be balloon expandable as would be understood by one of ordinary skill in the art.

[0069] Referring to FIG. 2, the valve component 104 of the prosthetic heart valve 100 is disposed inside and coupled to an interior surface of the frame 106. The valve component 104 includes three valve leaflets 108. Alternatively, the valve component 104 of the prosthetic heart valve 100 may include fewer or more valve leaflets 108. In an embodiment, the valve component 104 may include an inner skirt 121 and / or an outer skirt (not shown for clarity) as described in U.S. Patent Application Publication No. 2022 / 0175521 Al to Baldwin et al., previously is incorporated by reference herein in its entirety. The three valve leaflets 108 may be sewn using sutures or otherwise securely attached along their bases to the skirt at a margin of attachment (not shown). Adjoining pairs of valve leaflets 108 are attached to each other at their lateral ends to form commissures 114, with the three edges of the valve leaflets 108 forming coaptation edges that meet in an area of coaptation. As described above, each commissure 114 is coupled to a corresponding commissure post 111 of the frame 106. The valve component 104 is configured to block flow in one direction to regulate flow therethrough via the valve leaflets 108 that form a replacement bicuspid or tricuspid valve. The valve component 104 may be formed of various flexible materials including, but not limited to natural pericardial material such as tissue from bovine, equine or porcine origins, or synthetic materials such as polytetrafluoroethylene (PTFE), DACRON® polyester, pyrolytic carbon, or other biocompatible materials. With certain prosthetic leaflet materials, it may be desirable to coat one or both sides of the replacement valve leaflet with a material thatwill prevent or minimize overgrowth. It is further desirable that the prosthetic leaflet material is durable and not subject to stretching, deforming, or fatigue.

[0070] Each radiopaque marker 102 of the prosthetic heart valve 100 is coupled to the frame 106 and is configured to provide visual cues under fluoroscopic imaging to improve anatomical alignment or orientation of the prosthetic heart valve 100 with the native heart valve, as described below. In the embodiment of FIGS. 1-6, and as best illustrated in FIGS. 3-4, each marker 102 is generally V-shaped. In particular, each marker 102 includes a first leg 142, a second leg 144, and a base 146 forming a V-shape. The base 146 is disposed at a closed end of the V-shape. The radiopaque marker 102 may be disposed on an outer surface of the frame 106 with the base 146 disposed adjacent a corresponding crown 122 of the inflow crown row 136. In the embodiment of FIGS. 1-6, the base 146 of the radiopaque marker 102 is circumferentially oriented / aligned with the corresponding commissure post 111. In other words, as shown in FIG. 1, a longitudinal line parallel to the central longitudinal axis LA of the frame 106 extends through the commissure post 111 and the base 146 of the radiopaque marker 102. The first leg 142 distally extends from the base 146 to a first leg end 148 along a portion of an outer surface of a corresponding first strut 110A. In other words, the first leg 142 extends in a downstream direction from the base 146 along the first strut 110A towards the corresponding node 123 of the first node row 138. The second leg 144 distally extends from the base 146 to a second leg end 150 along a portion of an outer surface of a corresponding second strut HOB, in the downstream direction towards the corresponding node 123 of the first node row 138. As noted above, the closed end of the V-shaped radiopaque marker 102 is disposed at the inflow crown row 136 and is circumferentially oriented / aligned with the corresponding commissure post 111 and accordingly, with the corresponding commissure 114 of the valve component 104. The open end of the V-shaped radiopaque marker 102 faces the first node row 138.

[0071] Each radiopaque marker 102 may be formed of an elastic, biostable, and biocompatible radiopaque polyurethane tape, such as, but not limited to DMS Polaris Radiopaque Marker Tape. Such material visualizes well on fluoroscopy, is durable, can be cut to various shapes, and sewn to the frame 106. FIG. 5 shows a cross-stitch pattern with a plurality of cross-stitches 170 for coupling a radiopaque polyurethane tape marker 102 tothe frame 106. The frame 106 is omitted from FIG. 5 for clarity. While a particular stitch pattern is illustrated in FIG. 5 with a specific number of cross-stitches 170, this is merely an example, and other stitch patterns and / or more or fewer stitches may be utilized. The radiopaque marker 102 may be coupled to the frame 106, and moreover to other components in other embodiments such as, but not limited to the valve component 104 by thread or filament of any suitable suture material, such as, but not limited to silk, nylon, polypropylene, polyester, polytetrafluoroethylene, or other materials suitable for the purposes described herein.

[0072] FIG. 6 illustrates a 100mm x 100mm sheet 103 of radiopaque polyurethane tape. FIG. 7 illustrates a close-up view of a portion of the sheet 103 of FIG. 6. As shown in FIG. 7, V-shaped markers 102 may be cut from the sheet 103. As shown in FIG. 6, up to 756 V-shaped radiopaque markers 102 may be cut from a 100mm x 100mm sheet 103 of radiopaque polyurethane tape. The high density of the radiopaque markers 102 on each sheet 103 of polyurethane tape contributes to overall improved manufacturing efficiency and reduced manufacturing costs of adding a radiopaque marker to the prosthetic heart valve 100. In an embodiment, each radiopaque marker 102 may have a low profile such as, but not limited to 0.2mm.

[0073] As noted above, the radiopaque markers 102 may be used for longitudinal / depth alignment of the prosthetic heart valve 100 and for rotational alignment of the prosthetic heart valve 100 within a native aortic valve. In particular, in the embodiment of FIGS. 1-5 the second ends 148, 150 of the legs 142, 144 of each marker 102 may be disposed at a distance Hl from the inflow end 118 of the frame 106, which may also be expressed as a distance Hl from the inflow crowns 122 of the frame 106. In an embodiment, the distance Hl is about 2 mm to about 5 mm, or about 2.4 mm to about 4.6 mm, or about 2.6 mm to about 3.0 mm. Thus, during implantation, the markers 102 can be used to align the markers 102 with the annulus of the native heart valve to enable better depth positioning of the prosthetic heart valve 100 such that it can be more accurately deployed and reduce the incidence rate of requiring a permanent pacemaker (PPM) post-implantation.

[0074] With reference to FIGS. 8A-8B, the use of the three (3) markers 102 located with the second ends 148, 150 of the legs 142, 144 thereof at a lengthwise location of theframe 106 that is desired to be aligned with the annulus will be explained. In particular, the presence of the three (3) markers 102 facilitates identification of when parallax is present in the prosthetic heart valve 100 for a given fluoroscopic viewing angle. FIG. 8A shows an example of the prosthetic heart valve 100 with parallax present in the viewing angle. As can be seen in FIG. 8A, the second ends 148, 150 of the legs 142, 144 of the three (3) markers 102 are not in a line. Changing the viewing angle through operation of the C-arm gantry can be completed to result in the second ends 148, 150 of the legs 142, 144 of the three (3) markers 102 being aligned, as shown in FIG. 8B. Implant depth relative to the native aortic valve cusps can be more accurately assessed with parallax removed.

[0075] With the parallax removed, the prosthetic heart valve 100 may be manipulated in a proximal or distal direction such that the first ends 148, 150 of the first and second legs 142, 144 respectively, of the radiopaque marker 102 are each longitudinally oriented or aligned with a valve annulus AN of the native aortic valve AV. Proper longitudinal alignment prevents migration of the prosthetic heart valve 100 due to implantation of the prosthetic heart valve 100 too high (or in a distal direction) in the valve annulus AN, and prevents conductance disturbances due to implantation of the prosthetic heart valve 100 too low (or in a proximal direction) in the valve annulus AN. Although FIGS. 8A and 8B are shown with the prosthetic heart valve 100 deployed from a delivery system, this is not necessary. The prosthetic heart valve 100 can be partially deployed or still disposed in a sheath of the delivery system. Further information regarding use of markers 102 for depth alignment of the prosthetic heart valve 100 is described in U.S. Patent Application Publication No. 2021 / 0275299 Al to Peterson et al. and U.S. Patent Application Publication No. 2022 / 0175524 Al to Harewood et al., both of which are incorporated by reference herein in their entirety.

[0076] In embodiments, the markers 102 can be utilized to align circumferential or rotational orientation of the prosthetic heart valve 100. The markers 102 can allow a physician to correctly interpret the rotational orientation of the prosthetic heart valve 100 and to clock or rotate the heart valve prosthesis 200 relative to the anatomy to correct the rotational orientation, if necessary, to avoid blocking the ostia of the right coronary artery 208 and / or the left main coronary artery 210. In addition, markers 102 rotationally alignthe commissures of the prosthetic heart valve 100 so they rotationally align with the native valve commissures (as best as possible as the native commissures are not the idealized 120 degrees apart). Commissure to commissure alignment (prosthetic heart valve 100 commissure to native commissure) may improve prosthetic heart valve 100 hemodynamics and leaflet durability. To align the prosthetic heart valve 100, it can be rotated, in situ, by a delivery system to be positioned in a desired rotational alignment.

[0077] FIG. 8C shows a plan view of a target site 200 of a native aortic valve as viewed from the aorta, showing the right coronary cusp 202, the left coronary cusp 204, and the non-coronary cusp 206, the right / left commissure 220, right / non-coronary commissure 222, and left / non-coronary commissure 224. FIG. 8C shows an idealized native aortic valve with the native commissures spaced at 120° around the circumference of the native aortic valve sinus. Those skilled in the art will recognize that patient anatomies vary from this idealized representation. FIG. 8C also shows a cusp overlap viewing angle VA. In the cusp overlap viewing angle shown in FIG. 8C, the right coronary cusp 202 and the left coronary cusp 204 are aligned with each other, i.e., they overlap, and the non-coronary cusp 206 is isolated and to the left of the right coronary cusp 202 and the left coronary cusp 204, as also shown in FIG. 8D. FIG. 8C shows “perfect” alignment of the markers 102 of the prosthetic heart valve 100 with the native commissures 220, 222, 224. As noted above, such “perfect” alignment is often not possible due to variations in patient anatomy. FIG. 8D shows a fluoroscopic image of a native aortic valve with C-arm gantry of the fluoroscopic imaging system in the cusp overlap viewing angled. Using the cusp overlap viewing angle with the non-coronary cusp 206 isolated, the prosthetic heart valve 100 is properly rotationally aligned when two of the markers 102 are substantially aligned with each other on the left side of the fluoroscopic image, as shown in FIG. 8D. FIG. 8D does not show other features that may be seen in a fluoroscopic image for clarity.

[0078] U.S. Patent Application Publication No. 2022 / 0175524 Al to Harewood et al. (“the ‘524 publication”), incorporated by reference herein in its entirety, shows a prosthetic heart valve including markers adjacent the inflow end of the frame thereof. The ‘524 publication describes the cusp overlap viewing angle explained above, and shows different examples of fluoroscopic images of the markers indicating that the prostheticheart valve is properly or improperly rotationally aligned. Further, other image planes or viewing angles and methods for rotational orientation may also be used. For example, and not by way of limitation, the ‘524 publication also shows a coronary overlap viewing angle of the imaging system. The methods and systems described in the ‘524 publication for rotationally aligning the heart valve prosthesis are incorporated by reference herein in their entirety.

[0079] In another embodiment illustrated in FIGS. 9-12, a prosthetic heart valve 900 includes one or more radiopaque markers 902, a valve component 904, and a frame 906. The valve component 904 and the frame 906 of the prosthetic heart valve 900 may be substantially similar to the valve component 104 and the frame 106 of the prosthetic heart valve 100 described previously. However, in the embodiment of FIGS. 9-12, there are nine (9) cells and nine (9) crowns at the outflow end 920 of the frame 906, whereas in the embodiment of FIGS. 1-5, there are five (5) cells and five (5) crowns at the outflow end 120 of the frame 106. Thus, in the embodiment of FIGS. 1-5, the crowns 122 at the inflow node row 136 are axially aligned with the commissure posts 111, whereas in the embodiment of FIGS. 9-12, the nodes 923 at the first node row 938 are axially aligned with commissure posts 911. Accordingly, parts of the valve component 904 and the frame 906 of the prosthetic heart valve 900 will use the similar reference numerals, such as, but not limited to the valve component 904, the frame 906, a plurality of struts 910, an inflow end 918, a first strut row 930, and a first node row 938 and these similar parts will not be described again. In embodiments hereof, each radiopaque marker 902 is coupled to the frame 906, as described below. Each radiopaque marker 902 is configured to provide visual cues during fluoroscopic imaging for improved and optimized anatomical alignment of the prosthetic heart valve 900 with a native heart valve.

[0080] In embodiments of FIGS. 9-12, each radiopaque marker 902 includes a first leg 942, a second leg 944, and a base 946. In an embodiment, a distal end of the base 946 may include a depression 947, as shown in FIG. 11. The base 946 of each radiopaque marker 902 may be disposed on an outer surface of the frame 906 adjacent the node 923 A of the first node row 938. The node 923 A is rotationally oriented with a corresponding commissure post 911 (FIG. 9) of the frame 906.

[0081] The first leg 942 proximally extends from the base 946 to a first end 948 along a portion of an outer surface of a corresponding first strut 910A, in an upstream direction towards the corresponding crown 922A. The second leg 944 proximally extends from the base 946 to a first end 950 along a portion of an outer surface of a corresponding second strut 91 OB. The second leg 944 extends in the upstream direction towards the corresponding crown 922 at the inflow end 918. The closed end of the V-shape of the radiopaque marker 902 is disposed at the node 923 and is rotationally oriented with a corresponding commissure post 911 and the corresponding commissure (not shown) of the valve component 904 coupled to the commissure post 911. The open end of the radiopaque marker 902 faces the inflow end 918.

[0082] Each radiopaque marker 902 may be formed of materials and coupled to the frame 906 as previously described with respect to the radiopaque marker 102 of FIGS. 1- 6.

[0083] Similar to the embodiment above, the radiopaque markers 902 may be used for longitudinal / depth alignment of the prosthetic heart valve 100 and for rotational alignment of the prosthetic heart valve 100 within a native aortic valve. In particular, in the embodiment of FIGS. 9-12 the second ends 948, 950 of the legs 942, 944 of each marker 902 may be disposed at a distance Hl from the inflow end 918 of the frame 906, which may also be expressed as a distance Hl from the inflow crowns 922 of the frame 906. In an embodiment, the distance Hl is between about 2 mm and about 5 mm, or about 2.4 mm and about 4.6 mm, or about 2.6 mm and about 3.0 mm. Thus, during implantation, the markers 902 can be used to align the markers 902 with the annulus of the native heart valve to enable better depth positioning of the prosthetic heart valve 900 such that it can be more accurately deployed and reduce the incidence rate of requiring a permanent pacemaker (PPM) post-implantation.

[0084] Depth alignment and rotational alignment of the prosthetic valve 900 using the markers 902 may be the same as described above with respect to FIGS. 8A-8D. Depth alignment may be similar to the description above with respect to FIGS. 8A and 8B. FIG. 12A is similar to FIG. 8C, showing a native aortic valve as viewed from the aorta, with the markers 902 aligned with native commissures 220, 222, 224, and showing the cusp overlap viewing angle with the left and right coronary cusps 202, 204 overlapping and thenon-coronary cusp 206 isolated. As explained above, and shown in schematic fluoroscopic image of FIG. 12B, if the prosthetic heart valve 900 is properly rotationally aligned, two of the markers 902 will appear substantially aligned on the left side of the fluoroscopic image. As also described above, other rotational alignment methods and viewing angles may be used, such as the cusp overlap viewing angle and the coronary overlap viewing angle.

[0085] FIGS. 13-16 illustrate a prosthetic heart valve 1300 including radiopaque markers 1302, according to embodiments hereof. The prosthetic heart valve 1300 includes a valve component 1304 and a frame 1306, each of which is similar to the valve component 104 and the frame 106 of the prosthetic heart valve 100. Accordingly, the valve component 1304 and the frame 1306 will not be described in detail here. Parts of the prosthetic heart valve 1300 will use the similar reference numerals, such as, but not limited to, a frame 1306, a plurality of struts 1310, an inflow end 1318, a first strut row 1330, an inflow crown row 1336, and a first node row 1338. In embodiments hereof, the prosthetic heart valve 1300 includes three radiopaque markers 1302A, 1302B, and 1302C, as best seen in FIG. 14. During deployment of the prosthetic heart valve 1300 at a treatment site, each radiopaque marker 1302A, 1302B, 1302C is configured to provide visual references or cues for improved and optimized anatomical alignment or orientation of the prosthetic heart valve 1300 with a native heart valve under fluoroscopic imaging.

[0086] Referring to FIGS. 13-15, a first radiopaque marker 1302A includes a first leg 1342A, a second leg 1344A, and a base 1346A. In embodiments, the first radiopaque marker 1302A may also include a notch 1347. The first radiopaque marker 1302A may be similar to the radiopaque marker 902 described previously. However, the base 1346A of the first radiopaque marker 1302A is disposed on an outer surface of the frame 1306 adjacent a node 1323B of a second node row 1339 and coupled thereto. The first leg and the second leg 1342A, 1344A of the first radiopaque marker 1302A extend proximally from the base 1346A along a portion of an outer surface of the adjacent struts 1310. The first leg 1342A and the second leg 1344B extend from the base 1346A in an upstream direction towards a corresponding node 1323 of adjacent nodes 1323 of the first node row 1338. The first radiopaque marker 1302A forms an inverted V-shape at the second node row 1339 toward the first node row 1338. The base 1346A of the first marker 1302A isdisposed at one of the nodes 1323 of the second node row 1339 that is axially aligned with one of the commissure posts 1311 such that the base 1346A of the first marker is axially aligned with one of the commissures 1314 of the valve component 1304. The first radiopaque marker 1302A may be formed by methods and materials and coupled to the frame 1306 as described previously with respect to the radiopaque marker 102.

[0087] The second radiopaque marker 1302B and the third radiopaque mark 1302C each includes a first leg 1342B, a second leg 1344B, and a base 1346B. The second and third radiopaque markers 1302B, 1302C may be similar to the radiopaque marker 102 described previously, with the base 1346B of each of the second and third radiopaque marker 1302B disposed on an outer surface of the frame 1306 adjacent to a corresponding crown 1322 at the inflow end of the frame 1306. The first leg 1342B and the second leg 1344B each extend distally, or downstream from the base 1346B. The first and second legs 1342B, 1344B each extend distally towards the outflow end 1320 for at least a portion of the adjacent struts 1310 of the first strut row 1330 such that the first leg 1342B and the second leg 1344B diverge as they extend in the downstream direction. The second and third radiopaque markers 1302B, 1302C each forms a V-shape extending distally from a corresponding crown 1322 at the inflow end 318 of the frame 1306. The second and third radiopaque markers 1302B, 1302C may be formed of similar materials and by similar methods as described previously with respect to the radiopaque markers 102. The second and third radiopaque markers 1302B, 1302C may be coupled to the frame 1306 by methods as described previously with respect to the radiopaque marker 102.

[0088] The base 1346B of each of the second and third radiopaque markers 1302B, 1302C may be disposed at a crown 1322 of the inflow end 1318 of the frame that is substantially axially aligned with one of the commissures 1314 of the valve component 1304. Thus, in a heart valve prosthesis 1300 with a valve component 1304 with three leaflets, and thus three commissures 1314, each of the radiopaque markers 1302A, 1302B, 1302C is axially aligned with a corresponding one of the three commissures 1314. In other embodiments, two of the radiopaque markers 1302 may be the inverted V-shape and one may be V-shaped.

[0089] The second and third radiopaque markers 1302B, 1302C may be used for depth alignment as described above with respect to FIGS. 8 A and 8B.

[0090] For rotational alignment of prosthetic heart valve 1300, FIG. 16A is similar to FIG. 8C, showing a native aortic valve as viewed from the aorta, with the markers 1302 aligned with native commissures 220, 222, 224, and showing the cusp overlap viewing angle with the left and right coronary cusps 202, 204 overlapping and the non-coronary cusp 206 isolated. As explained above, and shown in schematic fluoroscopic image of FIG. 16B, if the prosthetic heart valve 1300 is properly rotationally aligned, the first marker 1302A and one of the second and third markers 1032B, 1302C will appear substantially aligned on the left side of the fluoroscopic image, as shown in FIG. 16B. Because the first marker 1302A is an inverted V-shape and the second and third markers 1302B, 1302C are V-shaped, when substantially axially aligned in the fluoroscopic image in the cusp overlap view, the first marker 1302A and one of the second and third markers 1302B, 1302C will appear diamond-shaped when the prosthetic heart valve 1300 is properly rotationally oriented, as shown in FIG. 14B.

[0091] In the embodiments above, the V-shaped and / or inverted V-shaped markers also enable a treating clinician to visualize that the frame of the prosthetic heart valve has properly radially expanded. In particular, because the legs of the V-shaped markers are disposed on struts of the frame, the legs of the V-shaped markers will open or separate as the frame radially expands. Thus, if the legs of the V-shaped markers do not open or separate, the treating clinician is alerted that the frame of the prosthetic heart valve may not have properly radially expanded.

[0092] FIGS. 17-19B illustrate radiopaque markers on a prosthetic heart valve according to embodiments hereof. Each embodiment will be described in greater detail below as part of a prosthetic heart valve, similar to the prosthetic heart valve 100 described above, except for the radiopaque markers. Accordingly, parts of the heart valve prostheses other than the radiopaque markers will use similar reference numerals, such as, but not limited to the valve component 104, the frame 106, the plurality of struts 110, the inflow end 118, the first strut row 130, the inflow node row 136, and the first node row 138. Thus, for brevity, these similar parts will not be described again. In the embodiments of FIGS. 17-19B, each radiopaque marker may comprise gold applied to a portion of a surface of a frame of the prosthetic heart valve as described below. For example, and not by way of limitation, each radiopaque marker may be disposed on an outer surface of theframe via a laser ablation process, for example the laser ablation process of ProPlate Gold Coating, or other suitable process. In more detail, the frame of the prosthetic heart valve may be masked in its entirety. A short pulse laser may be utilized to ablate or remove the masking material at desired radiopaque marker locations of the frame. Gold may be deposited on the outer surface of the frame in locations where the masking has been ablated, at a desired height, width, and thickness. In embodiments height may be in the range of 0.62mm - 1.10mm, the width may be in the range of 0.38mm - 1.13mm, and the thickness may be in the range of 0.04mm -0.06mm. Once the gold has been deposited as desired, the remaining masking on the frame may then be removed, and each radiopaque marker remains at the desired locations of the frame. In embodiments herein, each radiopaque marker is configured to provide visual cues under standard fluoroscopic imaging to improve and optimize the anatomical alignment or orientation of the respective prosthetic heart valve within a native heart valve. Optimally positioning of a prosthetic heart valve within a native heart valve minimizes possible complications including, but not limited to prosthetic heart valve migration and conductance disturbances.

[0093] With reference to FIG. 17 one or more radiopaque markers 1702 are disposed on a frame 1706 of a prosthetic heart valve 1700. The radiopaque markers 1702 of FIG. 17 are similar to those of FIGS. 1-5. However, each radiopaque marker 1702 is a gold coating as described above, and each radiopaque marker 1702 includes a first leg 1742 and a second leg 1744 disposed on an outer surface of the frame 1706, but does not include a base that extends across a crown 1722 at the inflow end 1718 of the prosthetic heart valve 1700. In certain embodiments, it may not be desirable to include a base when using a gold coating due to potential for flaking during radial compression and expansion. However, in other embodiments, a base may be utilized. Thus, the first leg 1742 of each marker 1702 includes a first end 1748 and a second end 1749. Similarly, the second leg 1744 includes a first end 1750 and a second end 1751. In the embodiment of FIG. 17 the first ends 1748 and 1750 of the first and second legs 1742, 1744 are each disposed adjacent a crown 1722A at the inflow end 1718 of the frame 1706. The first leg 1742 extends distally along a first strut 1710A extending from the crown 1722A towards a first node 1723 A of the first node row 1738. The second leg 1744 extends distally along a second strut 1710B extending from the crown 1722A towards a second node 1723B of the first node row1738. As described above, the second ends 1749, 1751 of the first and second legs 1742, 1744 may be disposed at a distance Hl from the inflow end 1718 of the frame 1706, which may also be expressed as a distance Hl from the inflow crowns 1722 at the inflow end 1718 of the frame 1706. In an embodiment, the distance Hl is between about 2 mm and about 5 mm, or about 2.4 mm and about 4.6 mm, or about 2.6 mm and about 3.0 mm.

[0094] The radiopaque marker 1702 of FIG. 17 is axially aligned with one of the commissure posts 1711 of the frame 1706, and hence with one of the commissures of the valve component 1704. In an embodiment the prosthetic heart valve 1700 of FIG. 17 includes three (3) radiopaque markers 1702, with each radiopaque marker 1702 being axially aligned with one of the commissure posts 1711, and hence with one of the commissures 1714.

[0095] Longitudinally and rotationally aligning the prosthetic heart valve 1700 of FIG. 17 may be accomplished in the same manner as described above with respect to the prosthetic heart valve 100, and thus is not repeated.

[0096] With reference to FIG. 18 one or more radiopaque markers 1802 are disposed on a frame 1806 of a prosthetic heart valve 1800. The radiopaque markers 1802 of FIG. 18 are similar to those of FIGS. 9-12. However, each radiopaque marker 1802 is a gold coating as described above, and each radiopaque marker 1802 includes a first leg 1842 and a second leg 1844 disposed on an outer surface of the frame 1806, but does not include a base that extends across node 1823 at the first node row 1838. Thus, the first leg 1842 of each marker 1802 includes a first end 1848 and a second end 1849. Similarly, the second leg 1844 includes a first end 1850 and a second end 1851. In the embodiment of FIG. 18, the first ends 1848, 1850 of the first and second legs 1842, 1844 are each disposed adjacent a node 1823A of the first node row 1838. The first leg 1842 extends proximally along a first strut 1810A extending from the node 1823 A towards a first crown 1822A at the proximal end 1818 of the frame 1806. The second leg 1844 extends proximally along a second strut 1810B extending from the nodes 1823 A towards a second crown 1822B at the proximal end 1818 of the frame 1806. As described above, the second ends 1849, 1851 of the first and second legs 1842, 1844 may be disposed at a distance Hl from the inflow end 1818 of the frame 1806, which may also be expressed as a distance Hl from the inflow crowns 1822 at the inflow end 1818 of the frame 1806. In an embodiment, the distance Hlis between about 2 mm and about 5 mm, or about 2.4 mm and about 4.6 mm, or about 2.6 mm and about 3.0 mm.

[0097] The radiopaque marker 1802 of FIG. 18 is axially aligned with one of the commissure posts 1811 of the frame 1806, and hence with one of the commissures of the valve component 1804. In an embodiment the prosthetic heart valve 1800 of FIG. 18 includes three (3) radiopaque markers 1802, with each radiopaque marker 1802 being axially aligned with one of the commissure posts 1811, and hence with one of the commissures 1814.

[0098] Longitudinally and rotationally aligning the prosthetic heart valve 1800 of FIG. 17 may be accomplished in the same manner as described above with respect to the prosthetic heart valve 900, and thus is not repeated.

[0099] With reference to FIGS. 19A-19B, radiopaque markers 1902A, 1902B, 1902C are disposed on a frame 1906 of a prosthetic heart valve 1900. The radiopaque markers 1902A, 1902B, 1902C of FIGS. 19A-19B are similar to those of FIGS. 13-16. However, each radiopaque marker 1902A, 1902B, 1902C is a gold coating as described above with respect to FIGS 17 and 18, and each radiopaque marker 1902A, 1902B includes a first leg 1942A, 1942B and a second leg 1944A, 1944B disposed on an outer surface of the frame 1906, but does not include a base that extends across a crown 1922 or a node 1923. In particular, in the embodiment of FIGS. 19A-19B, as in the embodiment of FIGS. 13-16, one of the radiopaque markers, in this embodiment the radiopaque marker 1902A is an inverted V-shape, and two of the radiopaque markers, in this embodiment the radiopaque markers 1902B and 1902C, are an inverted V-shape. However, as explained above with respect to the embodiment of FIGS. 13-16, in other embodiments there may be two inverted V-shape markers and one V-shape marker. Further, in other embodiments, there by be only two markers, with one being V-shaped, and the other being an inverted V- shape.

[0100] Similar to the embodiment of FIGS. 13-16, each radiopaque marker 1902A, 1902B, 1902C of FIGS. 19A-19B is axially aligned with a corresponding one of the commissure posts 1911 of the frame 1906, and hence with one of the commissures 1914 of the valve component 1904.

[0101] Longitudinally and rotationally aligning the prosthetic heart valve 1900 of FIG. 19 may be accomplished in the same manner as described above with respect to the prosthetic heart valve 1300, and thus is not repeated.

[0102] Similar to the embodiments with the V-shaped or inverted V-shape radiopaque tape markers, the embodiments of FIGS. 17-19 form the legs of a V-shape (or inverted V- shape). Therefore, radiopaque markers of FIGS. 17-19 enable a treating clinician to visualize that the frame of the prosthetic heart valve has properly radially expanded. In particular, because the legs of the are disposed on struts of the frame, the legs of the will open or separate as the frame radially expands. Thus, if the legs of do not open or separate, the treating clinician is alerted that the frame of the prosthetic heart valve may not have properly radially expanded.

[0103] While only some embodiments have been described herein, it should be understood that it has been presented by way of illustration and example only and not limitation. Various changes in form and detail can be made without departing from the spirit and scope of the disclosure aspects, and each feature of embodiments discussed herein and of each reference cited herein, can be used in combination with the features of any other embodiment. All patents and publications discussed herein are incorporated by reference herein in their entirety.

[0104] Example 1. A prosthetic heart valve configured to radially expand from a radially compressed configuration to a radially expanded configuration, the prosthetic heart valve comprising; a frame; a valve component disposed within and coupled to the frame; and a radiopaque marker, wherein the radiopaque marker is formed from a radiopaque polyurethane tape.

[0105] Example 2. The prosthetic heart valve of Example 1, wherein the radiopaque marker comprises a base, a first leg extending from the base, and a second leg extending from the base.

[0106] Example 3. The prosthetic heart valve of Example 2, wherein: the base of the radiopaque marker is disposed on a crown of the frame at an inflow end of the frame; the first leg extends distally from the base along a first strut extending from the crown towards a first node of a first node row spaced from the inflow end of the frame; and the second legextends distally from the base along a second strut extending from the crown towards a second node of the first node row.

[0107] Example 4. The prosthetic heart valve of any one of Examples 1 to 3, wherein the radiopaque marker is substantially V-shaped with the prosthetic heart valve in the radially expanded configuration.

[0108] Example 5. The prosthetic heart valve of Example 2, wherein: the base of the radiopaque marker is disposed on a node at a first node row of the frame spaced from an inflow end of the frame; the first leg extends proximally from the base along a first strut extending from the node towards a first crown of a first crown row at the inflow end of the frame; and the second leg extends proximally from the base along a second strut extending from the node towards a second crown of the first crown row.

[0109] Example 6. The prosthetic heart valve of Example 5, wherein the radiopaque marker is substantially an inverted V-shape with the prosthetic heart valve in the radially expanded configuration.

[0110] Example 7. The prosthetic heart valve of any one of Examples 1 to 6, wherein valve component comprises a plurality of leaflets with adjacent leaflets coupled to each other at commissures, and wherein the radiopaque marker is substantially axially aligned with a commissure of the commissures.

[0111] Example 8. The prosthetic heart valve of any one of Examples 1 to 7, wherein a first leg end of the first leg opposite the base and a second leg end of the second leg opposite the base are configured to be longitudinally aligned with an annulus of the native heart valve.

[0112] Example 9. The prosthetic heart valve of Example 8, wherein the first leg end and the second leg end are disposed a first height from the proximal end of the frame, wherein the first height is between about between about 2 mm and about 5 mm, or about 2.4 mm and about 4.6 mm, or about 2.6 mm and about 3.0 mm.

[0113] Example 10. The prosthetic heart valve of Example 1, wherein the radiopaque marker includes a first radiopaque marker and a second radiopaque marker, wherein the first radiopaque marker is V-shaped and the second radiopaque marker is an inverted V- shape, wherein the second radiopaque marker is circumferentially and longitudinally spaced from the first radiopaque marker.

[0114] Example 11. The prosthetic heart valve of Example 10, wherein the first radiopaque marker is substantially axially aligned with a first commissure of a plurality of commissures of the valve component and the second radiopaque marker is substantially axially aligned with a second commissure of the plurality of commissures of the valve component.

[0115] Example 12. The prosthetic heart valve of any Example 10 or Example 11, wherein: the first radiopaque marker includes a base disposed at a first crown at an inflow end of the frame, a first leg extends distally from the base along a first strut towards a first node of a first node row spaced from the inflow end, and a second leg extends distally from the base along a second strut towards a second node of the first node row; and the second radiopaque marker includes a base disposed at a first node of a second node row, a first leg extends proximally from the base along a third strut towards a third node of the first node row, and a second leg extends proximally from the base along a fourth strut towards a fourth node at the first node row.

[0116] Example 13. The prosthetic heart valve of Example 12, wherein corresponding distal ends of the first and second legs of the first radiopaque marker terminate at a first position between the inflow end of the frame and the first node row and corresponding proximal ends of the first and second legs of the second radiopaque marker terminate at a second position between the first node row and the second node row.

[0117] Example 14. The prosthetic valve of Example 14, wherein the first position is between about 2 mm and about 5 mm, or about 2.4 mm and about 4.6 mm, or about 2.6 mm and about 3.0 mm from the inflow end of the frame.

[0118] Example 15. The prosthetic heart valve of any one of Examples 10 to 14, wherein the heart valve prosthesis is configured such that when viewed in a fluoroscopic image, the heart valve prosthesis is properly rotationally aligned when the first radiopaque marker and the second radiopaque marker form a substantially diamond shape.

[0119] Example 16. The prosthetic heart valve of any one of Examples 1 to 15, wherein the prosthetic heart valve is configured to be deployed at a site of a native aortic heart valve, and wherein the radiopaque markers are configured to rotationally orient the prosthetic heart valve to avoid blocking ostia of the coronary arteries.

[0120] Example 17. The prosthetic heart valve of any of Examples 1 to 16, wherein the radiopaque marker is coupled to the prosthetic heart valve with sutures.

[0121] Example 18. A prosthetic heart valve configured to radially expand from a radially compressed configuration to a radially expanded configuration, the prosthetic heart valve comprising; a frame; a valve component disposed within and coupled to the frame; and a radiopaque marker, wherein the radiopaque marker is a gold coating.

[0122] Example 19. The prosthetic heart valve of Example 18, wherein the radiopaque marker comprises a first leg extending from a crown at the inflow end of the frame along a first strut extending distally from the crown, and a second leg extending from the crown along a second strut adjacent the first strut and extending from the first crown.

[0123] Example 20. The prosthetic valve of Example 18, wherein the radiopaque marker comprises a first leg extending from a node of a first node row spaced from the inflow end of the frame along a first strut extending proximally from the node, and a second leg extending from the first node along a second strut adjacent the first strut and extending proximally from the first node.

[0124] Example 21. The prosthetic valve of any one of Examples 18 to 20, wherein the radiopaque marker is substantially axially aligned with a commissure of the valve component.

[0125] Example 22. The prosthetic heart valve of Example 18, wherein the radiopaque marker includes a first radiopaque marker and a second radiopaque marker, wherein the first radiopaque marker comprises two legs of V-shape and the second radiopaque marker comprises two legs of an inverted V-shape, wherein the second radiopaque marker is circumferentially and longitudinally spaced from the first radiopaque marker.

[0126] Example 23. The prosthetic heart valve of Example 22, wherein the first radiopaque marker is substantially axially aligned with a first commissure of a plurality of commissures of the valve component and the second radiopaque marker is substantially axially aligned with a second commissure of the plurality of commissures of the valve component.

[0127] Example 24. The prosthetic heart valve of Example 22 or Example 23, wherein the prosthetic heart valve is configured such that when viewed in a fluoroscopic image, theprosthetic heart valve is properly rotationally aligned when the first radiopaque marker and the second radiopaque marker form a substantially diamond shape.

[0128] Example 25. The prosthetic heart valve of any one of Examples 18 to 24, wherein the prosthetic heart valve is configured to be deployed at a site of a native aortic heart valve, and wherein the radiopaque markers are configured to rotationally orient the prosthetic heart valve to avoid blocking ostia of the coronary arteries.

Claims

WHAT IS CLAIMED IS:

1. A prosthetic heart valve (100, 900, 1300) configured to radially expand from a radially compressed configuration to a radially expanded configuration, the prosthetic heart valve comprising; a frame (106, 906, 1306); a valve component (104, 904, 1304) disposed within and coupled to the frame; and a radiopaque marker (102, 902, 1302), wherein the radiopaque marker is formed from a radiopaque polyurethane tape.

2. The prosthetic heart valve of claim 1, wherein the radiopaque marker comprises a base (146, 946, 1346), a first leg (142, 942, 1342) extending from the base, and a second leg (144, 944, 1344) extending from the base.

3. The prosthetic heart valve of claim 2, wherein: the base (146) of the radiopaque marker (102) is disposed on a crown (122) of the frame (106) at an inflow end (118) of the frame; the first leg extends (142) distally from the base (146) along a first strut (110A) extending from the crown (122) towards a first node (123) of a first node row (138) spaced from the inflow end of the frame; and the second leg (144) extends distally from the base (146) along a second strut (100B) extending from the crown (122) towards a second node (123) of the first node row (138).

4. The prosthetic heart valve of any one of claims 1 to 3, wherein the radiopaque marker (102, 902, 1302) is substantially V-shaped with the prosthetic heart valve in the radially expanded configuration.

5. The prosthetic heart valve of claim 2, wherein: the base (946) of the radiopaque marker (902) is disposed on a node (923) at a first node row (938) of the frame (906) spaced from an inflow end (918) of the frame;the first leg (942) extends proximally from the base (946) along a first strut (910A) extending from the node towards a first crown (922) of a first crown row at the inflow end of the frame; and the second leg (944) extends proximally from the base (946) along a second strut (91 OB) extending from the node (923) towards a second crown (922) of the first crown row.

6. The prosthetic heart valve of claim 5, wherein the radiopaque marker (902) is substantially an inverted V-shape with the prosthetic heart valve in the radially expanded configuration.

7. The prosthetic heart valve of any one of claims 1 to 6, wherein valve component (104, 904, 1304) comprises a plurality of leaflets with adjacent leaflets (108, 908, 1308) coupled to each other at commissures (114, 914, 1314), and wherein the radiopaque marker is substantially axially aligned with a commissure of the commissures.

8. The prosthetic heart valve of any one of claims 1 to 7, wherein a first leg end (148, 948, 1348) of the first leg (142, 942, 1342) opposite the base (146, 946, 1346) and a second leg end (150, 950, 1350) of the second leg (144, 944, 1344) opposite the base are configured to be longitudinally aligned with an annulus of the native heart valve.

9. The prosthetic heart valve of claim 8, wherein the first leg end and the second leg end are disposed a first height from the proximal end of the frame, wherein the first height is between about 2 mm and about 5 mm, or about 2.4 mm and about 4.6 mm, or about 2.6 mm and about 3.0 mm.

10. The prosthetic heart valve of claim 1, wherein the radiopaque marker (1302) includes a first radiopaque marker (1302B) and a second radiopaque marker (1302A), wherein the first radiopaque marker (1302B) is V-shaped and the second radiopaque marker (1302A) is an inverted V-shape, wherein the second radiopaque marker is circumferentially and longitudinally spaced from the first radiopaque marker.

11. The prosthetic heart valve of claim 10, wherein the first radiopaque marker (1302B) is substantially axially aligned with a first commissure (1311) of a plurality of commissures of the valve component and the second radiopaque marker (1302A) is substantially axially aligned with a second commissure (1311) of the plurality of commissures of the valve component.

12. The prosthetic heart valve of any claim 10 or claim 11, wherein: the first radiopaque marker (1302B) includes a base (1346B) disposed at a first crown (1322) at an inflow end (1318) of the frame (1306), a first leg (1342B) extends distally from the base along a first strut towards a first node of a first node row spaced from the inflow end, and a second leg (1344B) extends distally from the base along a second strut towards a second node of the first node row; and the second radiopaque marker (1302A) includes a base (1346A) disposed at a first node of a second node row, a first leg (1342A) extends proximally from the base along a third strut towards a third node of the first node row, and a second leg (1344A) extends proximally from the base along a fourth strut towards a fourth node at the first node row.

13. The prosthetic heart valve of claim 12, wherein corresponding distal ends (1348B, 1350B) of the first and second legs of the first radiopaque marker terminate at a first position between the inflow end of the frame and the first node row and corresponding proximal ends (1348A, 1350A) of the first and second legs of the second radiopaque marker terminate at a second position between the first node row and the second node row.

14. The prosthetic valve of claim 14, wherein the first position is between about 2 mm and about 5 mm, or about 2.4 mm and about 4.6 mm, or about 2.6 mm and about 3.0 mm from the inflow end of the frame.

15. The prosthetic heart valve of any one of claims 10 to 14, wherein the heart valve prosthesis is configured such that when viewed in a fluoroscopic image, the heart valve prosthesis is properly rotationally aligned when the first radiopaque marker and the second radiopaque marker form a substantially diamond shape.

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