Implantable medical device having a visual orientation indicator

Abstract

The implantable medical device is adapted to be implanted at an implantation site within the vasculature and is capable of being implanted at the implantation site within the vasculature in two or more positions relative to the implantation site, which may include relative axial and / or relative rotational positions. The implantable medical device includes an expandable frame adapted to expand from a collapsed configuration for delivery to an expanded configuration for deployment, and one or more radiopaque markers positioned relative to the expandable frame such that fluoroscopic imaging of the implantable medical device during deployment provides an indication of the position of the implantable medical device relative to the implantation site. The implantable medical device may be, for example, a replacement heart valve, such as a replacement aortic valve.

Description

[Technical Field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates to medical devices and methods of making and using medical devices. More particularly, the present disclosure is directed to implantable medical devices having visual indicators that indicate proper orientation during and after implantation. [Background technology]

[0002] In medical applications, a wide variety of medical devices have been developed, for example, for use in accessing body cavities and interacting with fluids and structures therein. Some of these devices may include guidewires, catheters, pumps, motors, controllers, filters, pulverizers, needles, valves, and delivery devices and / or systems used to deliver such devices. These devices may be manufactured by any one of a variety of different manufacturing methods and used according to any one of a variety of methods. Each of the known medical devices and methods has certain advantages and disadvantages. Summary of the Invention

[0003] The present disclosure provides design, material, manufacturing, and use alternatives for medical devices. One example can be found in an implantable medical device adapted to be implanted at an implantation site within the vasculature, where the implantable medical device is capable of being implanted at two or more positions relative to the implantation site. The implantable medical device includes an expandable frame adapted to expand from a collapsed configuration for delivery to an expanded configuration for deployment, and one or more radiopaque markers positioned relative to the expandable frame such that fluoroscopic imaging of the implantable medical device during deployment provides an indication of the position of the implantable medical device relative to the implantation site.

[0004] Alternatively or additionally, at least some of the one or more radiopaque markers may be positioned to provide an indication of the axial position of the implantable medical device relative to the implantation site via fluoroscopic imaging.

[0005] Alternatively or additionally, at least some of the one or more radiopaque markers may be positioned to provide an indication of the rotational position of the implantable medical device relative to the implantation site via fluoroscopic imaging.

[0006] Alternatively or additionally, at least some of the one or more radiopaque markers may include radiopaque marker bands crimped onto portions of the expandable frame. Alternatively or additionally, at least some of the one or more radiopaque markers may include radiopaque wire wrapped around a portion of the expandable frame.

[0007] Alternatively or additionally, at least some of the one or more radiopaque markers may include radiopaque sutures sewn around a portion of the expandable frame. Another example can be found in a replacement heart valve adapted to be implanted within a native heart valve annulus, the replacement heart valve being capable of being implanted in two or more positions relative to the native heart valve annulus. The replacement heart valve includes an expandable frame adapted to expand from a collapsed configuration for delivery to an expanded configuration for deployment, and one or more radiopaque indicators positioned relative to the expandable frame such that fluoroscopic imaging of the replacement heart valve during deployment provides an indication of the position of the replacement heart valve relative to the native heart valve annulus. The expandable frame includes an annular portion adapted to engage the native heart valve annulus when deployed, a plurality of commissure posts adapted to extend above the native heart valve annulus when deployed, and valve material secured to the plurality of commissure posts, the valve material forming leaflets between each of the plurality of commissure posts.

[0008] Alternatively or additionally, at least some of the one or more radiopaque indicators may be adapted to provide an indication of the insertion depth of the replacement heart valve relative to the native heart valve annulus.

[0009] Alternatively or additionally, at least some of the one or more radiopaque indicators may be secured to an annular portion of the expandable frame adapted to engage the native heart valve annulus when deployed.

[0010] Alternatively or additionally, at least some of the one or more radiopaque indicators may be adapted to provide an indication of the relative rotational position of the replacement heart valve with respect to the native heart valve annulus.

[0011] Alternatively or additionally, at least some of the one or more radiopaque indicators may be secured to at least some of the plurality of commissure posts. Alternatively or additionally, the expandable frame may include a plurality of struts, one or more of which are adapted to house at least some of the one or more radiopaque indicators.

[0012] Alternatively or additionally, one or more of the plurality of struts may be formed with a constricted portion adapted to accommodate a radiopaque marker band therearound. Alternatively or additionally, the expandable frame may include a plurality of loops, one or more of which are adapted to house one or more radiopaque indicators within at least some of the loops.

[0013] Another example can be found in an aortic valve adapted to be implanted within a native aortic valve annulus, the aortic valve being capable of being implanted in two or more positions relative to the native aortic valve annulus. The aortic valve includes an expandable frame adapted to expand from a collapsed configuration for delivery to an expanded configuration for deployment, an annular portion adapted to engage the native aortic valve annulus when deployed, a plurality of commissural posts adapted to extend above the native heart valve annulus when deployed, a plurality of stabilizing arches adapted to extend above the plurality of commissural posts, and valve material secured to the plurality of commissural posts, the valve material forming leaflets between each of the plurality of commissural posts. A plurality of radiopaque indicators are positioned relative to the expandable frame such that fluoroscopic imaging of the aortic valve during deployment provides an indication of the position of the aortic valve relative to the native aortic valve annulus.

[0014] Alternatively or additionally, at least some of the plurality of radiopaque indicators may be adapted to provide an indication of the insertion depth of the aortic valve relative to the native aortic valve annulus.

[0015] Alternatively or additionally, at least some of the plurality of radiopaque indicators may be secured to an annular portion of the expandable frame adapted to engage the native aortic valve annulus when deployed.

[0016] Alternatively or additionally, at least some of the plurality of radiopaque indicators may be adapted to provide an indication of the relative rotational position of the aortic valve with respect to the native aortic valve annulus.

[0017] Alternatively or additionally, at least some of the plurality of radiopaque indicators may be secured to at least some of the plurality of commissure posts. Alternatively or additionally, at least some of the plurality of radiopaque indicators may be adapted to provide an indication of the insertion depth of the aortic valve relative to the native aortic valve annulus, and at least some of the plurality of radiopaque indicators are adapted to provide an indication of the relative rotational position of the aortic valve relative to the native aortic valve annulus.

[0018] The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present disclosure. The following figures and detailed description more particularly exemplify these embodiments.

[0019] A more complete understanding of the present invention can be obtained from the following detailed description of various embodiments of the invention when considered in conjunction with the accompanying drawings, in which: [Brief explanation of the drawings]

[0020] [Figure 1A] 1A-1C are diagrams of an expandable frame of an exemplary replacement aortic valve. [Figure 1B] 1B is a diagram of an exemplary replacement aortic valve including the expandable frame of FIG. 1A. [Figure 2A] 1 is a schematic diagram of an exemplary replacement aortic valve in a first axial position relative to the native aortic annulus. [Figure 2B] 1 is a schematic diagram of an exemplary replacement aortic valve in a second axial position relative to the native aortic annulus. [Figure 3A] 1 is a schematic diagram of an exemplary replacement aortic valve that is misaligned relative to the native aortic valve. [Figure 3B] FIG. 1 is a schematic diagram of an exemplary replacement aortic valve in proper alignment with the native aortic valve. [Figure 4] 1 is a schematic diagram of an exemplary replacement aortic valve. [Figure 5A] FIG. 1 is a diagram of an exemplary replacement aortic valve showing possible locations of various radiopaque indicators or markers. [Figure 5B]FIG. 1 is a diagram of an exemplary replacement aortic valve showing possible locations of various radiopaque indicators or markers. [Figure 5C] FIG. 1 is a diagram of an exemplary replacement aortic valve showing possible locations of various radiopaque indicators or markers. [Figure 5D] FIG. 1 is a diagram of an exemplary replacement aortic valve showing possible locations of various radiopaque indicators or markers. [Figure 6A] FIG. 1 is a diagram of an exemplary laser-cut blank for forming a replacement aortic valve, showing features for accommodating radiopaque marker bands. [Figure 6B] FIG. 6B is an enlarged view of a portion of FIG. 6A. [Figure 7A] FIG. 1 is a diagram of an exemplary laser-cut blank for forming a replacement aortic valve, showing features for accommodating radiopaque marker bands. [Figure 7B] FIG. 7B is an enlarged view of a portion of FIG. 7A. [Figure 8] 1A-1C are diagrams of exemplary laser cut blanks for forming a replacement aortic valve. [Figure 9A] 9 is a schematic cross-sectional view of an exemplary radiopaque pin that can be used with the laser-cut blank of FIG. 8. [Figure 9B] FIG. 9 is a side view of an exemplary radiopaque pin and suture for the laser-cut blank of FIG. 8. [Figure 10A] 1A-1C are diagrams of an exemplary replacement aortic valve including radiopaque sutures. [Figure 10B] 1A-1C are diagrams of an exemplary replacement aortic valve including radiopaque sutures. DETAILED DESCRIPTION OF THE INVENTION

[0021] While the present disclosure is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It is to be understood, however, that the invention is not intended to limit the disclosure to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure.

[0022] For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification. All numerical values ​​herein are assumed to be modified by the term "about," whether explicitly stated or not. The term "about" generally refers to a range of numerical values ​​that one of ordinary skill in the art would consider equivalent to the recited value (i.e., having the same function or result). In many instances, the term "about" can include numbers that are rounded to the nearest significant figure.

[0023] The recitation of numerical ranges by endpoints includes all numbers within that range (eg, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally used in its sense including "and / or" unless the content clearly dictates otherwise.

[0024] The following detailed description should be read with reference to the drawings, in which like elements in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the invention.

[0025] Numerous implantable medical devices are implanted at a variety of different implantation sites within a patient. In some cases, some implantable medical devices are capable of being implanted in more than one possible position at a particular implantation site. For example, some implantable medical devices may be capable of being implanted in more than one axial position relative to the implantation site based on their configuration or overall shape. For example, if the implantation site is a valve annulus, the implantable medical device may be capable of being implanted at different penetration depths relative to the valve annulus. Some anatomical structures and / or physician preferences may dictate a more proximal implantation location or a relatively smaller penetration depth. Some anatomical structures and / or physician preferences may dictate a more distal implantation location or a relatively greater penetration depth.

[0026] Some implantable medical devices may be capable of being implanted in two or more rotational positions relative to the implantation site based on their configuration or overall shape. In some cases, an implantable medical device may be capable of being implanted in two or more axial positions and two or more rotational positions relative to the implantation site. With respect to rotational position, which may refer to the relative rotational orientation of an implantable medical device, the implantable medical device may be implanted such that a particular reference point on the implantable medical device can face any particular rotational point defined along a 360-degree circle, for example. The reference point may face a 45-degree or 310-degree direction, or any of a variety of different directions. For some implantable medical devices, rotational position or orientation may not be important. For some implantable medical devices, rotational position or orientation may be important.

[0027] For ease of explanation, the present disclosure is directed to implantable medical devices that are replacement heart valves, such as transcatheter-deliverable replacement aortic valves, however, the disclosure is not intended to be so limited, and the replacement aortic valves described herein are merely exemplary.

[0028] 1A and 1B are side views of an exemplary replacement heart valve 10. The replacement heart valve 10 may be, for example, a replacement aortic valve, a replacement mitral valve, a replacement pulmonary valve, or a replacement tricuspid valve. In some cases, the replacement heart valve 10 may include biological tissue, such as porcine or bovine pericardium, and / or natural heart valve leaflets, such as natural porcine heart valve leaflets. In some cases, the natural heart valve leaflets may be attached to portions of natural heart wall tissue. The biological material may be fixed, for example, using glutaraldehyde.

[0029] The replacement heart valve 10 includes an expandable frame 12, which may be compressible into a radially compressed or folded configuration for delivery using a delivery catheter and expandable to an expanded configuration (as shown) during implantation. The replacement heart valve 10 may include a plurality of leaflets defining a valve 14 (as seen in FIG. 1B), the positions of which are indicated schematically by phantom lines. The leaflets defining the valve 14 can be seen, for example, in FIGS. 3A and 3B (including leaflets 42a, 42b, and 42c).

[0030] In some cases, the expandable frame may include a lower tubular or crown portion 16, an upper crown portion 18, a plurality of upstanding commissure posts 20, and a plurality of stabilizing arches 22. In use, the lower portion 16 of the expandable frame 12 may be adapted to be deployed after other regions of the expandable frame 12. For example, the arches 22, supports 20, and upper crown 18 may be deployed at least partially before the lower portion 16 (in that order, or in the reverse order, or in a different order). Once at least the upper crown 18 is at least partially deployed, the expandable frame 12 may be biased and / or displaced in the direction of arrow 24 to seat the upper crown 18 against the native valve leaflets at the implantation site. Deploying the lower portion 16 last secures the expandable frame 12 in its final position.

[0031] The lower portion 16, and optionally a portion of the upper crown 18, may be formed by a lattice structure of the stent. The lattice structure may define cells or openings, for example, generally diamond-shaped openings. In some cases, the native valve leaflets may generally overlap with portion 26 of the expandable frame 12. The native valve annulus may overlap with portion 28 of the expandable frame. In some cases, the lower portion 16 may have a cusp formed with a substantially zigzag shape. The zigzag shape may include a lower apex 16a and an upper apex 16b. The upper apex 16b may be hidden in FIG. 1 by the overlapping representation of both the anterior and posterior most cells of the lattice structure. The zigzag shape may be substantially continuous around the circumference of the expandable frame 12.

[0032] The expandable frame 12 may optionally be self-expanding, compressible to a compressed configuration for loading into a delivery catheter for delivery to the implantation site. In use, by removing the restraining effect of the sheath that holds the expandable frame 12 in the compressed configuration, the expandable frame 12 self-expands to or toward the operating configuration. A self-expanding stent may be, for example, a shape memory material, such as a shape memory alloy, for example, Nitinol. Alternatively, the expandable frame 12 may be configured to be expanded by application of a shortening force from the delivery catheter and / or by application of an expansion force from the delivery catheter, such as by using a dilation balloon. These are merely examples.

[0033] 2A shows a schematic diagram of a replacement heart valve 10 implanted within a native heart valve annulus 30. It will be understood that the native heart valve annulus 30 is shown schematically and, for ease of illustration, the native heart valve leaflets are not shown. In FIG. 2A, it can be seen that the replacement heart valve 10 is implanted, or at least positioned, at a first axial position or penetration depth relative to the native heart valve annulus 30. In FIG. 2B, it can be seen that the replacement heart valve 10 is implanted, or at least positioned, at a second axial position or penetration depth relative to the native heart valve annulus 30. In some cases, the replacement heart valve 10 may include a tissue skirt (not shown) extending downward (in the orientation shown), for example, to the lower apex 16a.

[0034] In some cases, a physician may have preferences regarding a preferred axial location or penetration depth for implantation of the replacement heart valve 10. In some cases, unique features of the patient's anatomy, such as, but not limited to, the particular anatomical structure of the patient's native heart valve annulus 30 or the sizing of the native valve leaflets that are pushed laterally by the replacement heart valve 10, may suggest a particular axial location or penetration depth into the native heart valve annulus 30. Particular features of the patient's vasculature may determine the optimal positioning of the stabilizing arches 22. Any of a variety of different anatomical features may determine the optimal axial location of the replacement heart valve 10 for a particular patient. As described below, the replacement heart valve 10 may include features that allow for easy identification of the axial location or penetration depth of the replacement heart valve 10 during implantation. In some cases, the replacement heart valve 10 may include features that are visible via fluoroscopy.

[0035] In some cases, the relative rotational position or orientation of the replacement heart valve 10 may be important, particularly if the replacement heart valve 10 is a replacement aortic valve intended for implantation within the native aortic annulus. In some cases, portions of the replacement heart valve 10 may potentially obstruct subsequent access to the coronary arteries. In some patients, particularly young patients, it may be necessary to subsequently implant a new replacement aortic valve several years after the initial implantation. In some patients, it may be necessary to access one or more of the coronary arteries, either immediately or in the future, for example, to perform angioplasty or rotational atherectomy. It may be necessary to access one or more of the coronary arteries to implant one or more stents. This may be problematic if the initially implanted replacement aortic valve obstructs access to the coronary arteries.

[0036] 3A shows a schematic diagram of a replacement aortic valve 34 implanted within a native aortic valve annulus 36. The replacement aortic valve 34 may be considered an example of the replacement heart valve 10 shown and described in FIGS. 1A and 1B. The replacement aortic valve 34 includes an expandable frame 38, which may be similar to the expandable frame 12. The expandable frame 38 includes several commissure posts 40. In some cases, the leaflets 42, individually labeled 42a, 42b, and 42c, are fixed relative to the commissure posts 40. As shown, a coronary artery 44 and a coronary artery 46 are each connected to the native aortic valve annulus 36.

[0037] 3A illustrates an insufficient rotational orientation of replacement aortic valve 34, with one of commissure posts 40 at least partially blocking coronary artery 44 and another of commissure posts 40 at least partially blocking coronary artery 46. While both coronary arteries 44 and 46 are shown as being partially blocked, in some cases, the particular locations of coronary arteries 44 and 46 in some patients may mean that an insufficient rotational orientation of replacement aortic valve 34 may result in a condition in which only one of coronary arteries 44 and 46 is at least partially blocked.

[0038] 3B illustrates the optimal rotational orientation of the replacement aortic valve 34, with none of the commissure posts 40 blocking the coronary artery 44 and none of the commissure posts 40 blocking the coronary artery 46. As a result of this rotational orientation, the replacement aortic valve 34 should not cause problems, or at least cause fewer problems, if a second replacement aortic valve needs to be implanted in the future. This also means that the coronary arteries 44 and 46 are easily accessible for any subsequent procedures within the coronary arteries 44 and 46, such as, but not limited to, angioplasty, rotational atherectomy, or stent implantation. As described below, the replacement aortic valve 34 may include features that allow for easy identification of the rotational orientation or position of the replacement aortic valve 34 during implantation. In some cases, the replacement aortic valve 34 may include features that are visible via fluoroscopy.

[0039] As discussed above, implantable medical devices, such as replacement heart valves, may include features that allow the relative axial and / or rotational positioning of the implantable medical device to be viewed under fluoroscopy. Figure 4 is a diagram of an exemplary replacement aortic valve 48 shown positioned within an aorta 50, where the replacement aortic valve 48 engages a native aortic valve annulus 52. The replacement aortic valve 48 includes an expandable frame 54, which includes stabilizing arches 56, commissure posts 58, an upper crown portion 60, and a lower crown portion 62. The replacement aortic valve 48 includes a tissue valve 64 supported by the expandable frame 54, as well as a tissue skirt 66.

[0040] 4 illustrates possible locations where radiopaque indicators or markers may be located. In some cases, if it is desired to be able to confirm the relative rotational orientation or relative rotational positioning of the replacement aortic valve 48 under fluoroscopy, the radiopaque indicators or markers may be fixed relative to the commissure posts 58 at location 68. In some cases, if it is desired to be able to confirm the relative axial positioning or penetration depth with respect to the native aortic valve annulus 52 under fluoroscopy, the radiopaque indicators or markers may be fixed relative to the replacement aortic valve 48 along line 70, such as at locations 70a and 70b. There may also be one or more additional radiopaque indicators or markers positioned along the back side (not visible in this orientation) of the replacement aortic valve 48.

[0041] In some cases, radiopaque indicators or markers positioned along line 70 may be aligned perpendicularly with, for example, commissure posts 58, in which case the same radiopaque indicators or markers may indicate both the axial and rotational positioning of the replacement aortic valve 48 relative to the native aortic valve annulus 52. The replacement aortic valve 48 may be rotated, as necessary, so that the radiopaque indicators or markers are properly aligned with the native aortic valve annulus 52 so that the expandable frame 54 does not obstruct access to the coronary arteries 44 and 46 ( FIGS. 3A and 3B ). Because the radiopaque indicators or markers are also positioned along line 70, the same radiopaque indicators or markers may also indicate, under fluoroscopy, the relative axial position of the replacement aortic valve 48 relative to the native aortic valve annulus 52.

[0042] FIGS. 5A, 5B, 5C, and 5D each illustrate an exemplary replacement aortic valve with radiopaque indicators or markers added using various techniques. FIG. 5A illustrates an exemplary replacement aortic valve 72 similar to replacement aortic valve 48. Replacement aortic valve 72 includes a loop with a marker band pack added. In some cases, the loop may be formed from a wire or composite thread applied as a single element with the ends fused or terminated together either thermally or mechanically to form the loop. In some cases, the loop ends may terminate within the pack or band. The marker band pack may be formed from a radiopaque material, such as, but not limited to, gold or tantalum. The loop with marker band pack 74 is shown secured to commissure post 58. The loop with marker band pack 76 is shown secured to upper crown portion 60. The loop with marker band pack 78 is shown secured to expandable frame 54 along line 70. The loop with marker band 80 is shown secured to lower crown portion 62. The marker bands may be open-ended crimped or swaged onto a mating shape, but may remain radially open. It will be appreciated that the loops with the marker bands may be secured in any of a variety of different locations around the replacement aortic valve 72, depending on which positioning feature it is desired to control.

[0043] FIG. 5B shows an exemplary replacement aortic valve 82 similar to replacement aortic valve 48. Replacement aortic valve 82 includes a radiopaque wire wrapped around the expandable frame 54 or the tissue forming either the tissue valve 64 or the tissue skirt 66. The radiopaque wire may be formed, for example, from gold or tantalum. As shown, the radiopaque indicator may be formed at location 84 by wrapping the radiopaque wire around the commissure posts 58. While in some cases only one of the commissure posts 58 is shown as including a radiopaque wire wrapped around it, in some cases each of the commissure posts 58 may include a radiopaque wire wrapped around it. Replacement aortic valve 82 includes a radiopaque indicator formed at location 86 located along line 70 by wrapping the radiopaque wire around a portion of the expandable frame 54.

[0044] FIG. 5C illustrates an exemplary replacement aortic valve 88 similar to replacement aortic valve 48. The replacement aortic valve 88 includes a radiopaque marker band positioned at location 90 adjacent to one of the commissure posts 58. While only one commissure post 58 is shown as including a radiopaque marker band, it will be understood that, in some cases, each of the three commissure posts 58 may include a radiopaque marker band. The marker band may be formed, for example, from gold or tantalum. The replacement aortic valve 88 includes a radiopaque marker band positioned at location 92 located along line 70. Although one radiopaque marker band is shown along line 70, in some cases, the replacement aortic valve 88 may include multiple radiopaque marker bands along line 70. Although not shown in this manner, the radiopaque marker bands along line 70 may be aligned with the commissure posts 58 to provide both axial and rotational positioning of the replacement aortic valve 88 relative to the native aortic valve annulus 52.

[0045] 5D shows an exemplary replacement aortic valve 94 similar to replacement aortic valve 48. The replacement aortic valve 94 includes radiopaque sutures or film at locations 96 relative to the commissure posts 58. The radiopaque sutures or film may be secured to the tissue valve 64 or to the commissure posts 58 themselves. While only one commissure post 58 is shown as including radiopaque sutures or film, in some cases, each of the three commissure posts 58 may include radiopaque sutures or film. The replacement aortic valve 94 includes radiopaque sutures or film at locations 98 disposed along line 70. The replacement aortic valve 94 includes radiopaque sutures or film at locations 100 located along the lower crown portion 62.

[0046] The expandable frames 12, 38, and 54 can be formed in a variety of ways. In some cases, the expandable frames 12, 38, and 54 can be laser cut from, for example, Nitinol tubing. FIG. 6A shows an exemplary laser cut pattern 102 that can be used to create one of the expandable frames described herein. The laser cut pattern 102 is shown schematically in two dimensions, even though the cross section of the laser-cut tubing is circular. A portion of the laser cut pattern 102 is enlarged in FIG. 6B to better illustrate the features of the laser cut pattern 102 that allow radiopaque marker bands to be secured to the laser cut pattern 102. As can be seen, the laser cut pattern 102 includes multiple "X" shapes, with pairs of struts 104, 106, and 108 meeting before separating again. A pair of struts 104 meets at an intersection region 104a having a first profile. A pair of struts 106 meets at an intersection region 106a having a second profile. A pair of struts 108 meet at an intersection region 108a having the same second profile. The second profile includes a narrowed portion that allows a marker band, such as marker band 110 shown in phantom, to be crimped around the intersection region. In some cases, intersection regions 104a, 106a, and 108a may be aligned in a row, as shown. In some cases, intersection regions 104a, 106a, and 108a may be offset, with some above and some below a midpoint defined between them. Marker band 110 may be formed from any radiopaque material, such as, for example, gold or tantalum.

[0047] FIG. 7A shows an exemplary laser cut pattern 112 that can be used to create one of the expandable frames described herein. The laser cut pattern 112 is shown schematically in two dimensions, even though the cross section of the laser cut tube is circular. A portion of the laser cut pattern 112 is enlarged in FIG. 7B to better illustrate the features of the laser cut pattern 112 that allow radiopaque marker bands to be secured to the laser cut pattern 112. As can be seen, the laser cut pattern 112 includes multiple "X" shapes, with pairs of struts 114, 116, and 118 meeting before separating again. A pair of struts 114 meets at an intersection region 114a having a first profile. A pair of struts 116 meets at an intersection region 116a having a second profile. In some cases, the pair of struts 116 includes a region 120 that extends upward from the intersection region 116a (in the orientation shown) and is adapted not to bend, comply, or contribute to the radial expansion of the implant. The pair of struts 118 meet at the intersection region 118a, which has the same first profile. The second profile includes a narrowed portion that allows a marker band to be crimped around the intersection region. In some cases, the intersection regions 114a, 116a, and 118a may be aligned in a row. In some cases, as shown, the intersection regions 114a, 116a, and 118a may be misaligned, with some above and some below a midpoint defined between them. In some cases, the added length of the intersection region 116a may improve the strain relaxation distribution. The marker band may be formed from any radiopaque material, such as gold or tantalum. In some cases, the marker band may be welded or swaged into place relative to the laser cut pattern 112 .

[0048] FIG. 8 shows an exemplary laser cut pattern 126 that can be used to create one of the expandable frames described herein. The laser cut pattern 112 is shown generally in two dimensions, even though the cross section of the laser-cut tube is circular. The laser cut pattern 112 can include slots 123 formed within each of the commissure posts 122. In some cases, the slots 123 can be adapted to allow tissue or other material to be pulled through the slots 123, and then a radiopaque pin can be inserted through the material to hold it against the slots 123. This can be seen, for example, in FIGS. 9A and 9B.

[0049] FIG. 9A shows a radiopaque pin 128 that may be used in combination with one of the slots 123 to help hold tissue or other material in place. FIG. 9A may be considered a top view because the top of the radiopaque pin 128 is visible. As seen in FIG. 9A , a membrane 132 (which may represent tissue forming part of the valve 14, for example) is pulled through the slot 123 formed in the commissure post 122. In some cases, as shown, the membrane 132 is at least partially surrounded by a PET fabric 130. The membrane 132 and the PET fabric 130 are held in place relative to the commissure post 122 by inserting the radiopaque pin 128. Because the radiopaque pin 128 is coated with or formed from a radiopaque material, the radiopaque pin 128 will be visible during fluoroscopy. The radiopaque pin 128 may be laser cut and polished, stamped, machined, or 3D printed.

[0050] 9B is an enlarged side view of the commissure post 122 showing the PET fabric 130 pulled through the slot 123. A radiopaque pin 128 is inserted into the space formed by the PET fabric 130, thereby preventing the PET fabric 130 from being pulled back through the slot 123. Although not shown, since the PET fabric 130 is on the outside, the membrane 132 also extends through the slot 123 and is held in place by the radiopaque pin 128. As can be seen, the commissure post 122 includes multiple openings 124 through which the sutures 127 extend. The sutures 127 help hold everything together. In some cases, the sutures 127 may include or be made of a radiopaque material so that they are visible during fluoroscopy. The suture 127 may include or be formed from materials such as polyester, polyurethane, nylon, silk, or collagen, and may be coated with a radiopaque material such as platinum, tantalum, iridium, carbon, gold, graphene, and tungsten, and composites thereof. The suture 127 may be coated with a radiopaque material such as barium, iodine, bismuth, tungsten, or combinations thereof. In some cases, the radiopaque coating on the suture 127 may include one or more radiopaque materials disposed within the coating material.

[0051] In some cases, radiopaque sutures may be provided in or on other portions of the replacement aortic valve to provide radiopaque indicators. Figures 10A and 10B show illustrative, but non-limiting, examples of exemplary replacement aortic valves that include radiopaque sutures as radiopaque indicators. Figure 10A provides examples of using radiopaque sutures to provide commissure alignment (rotational orientation or position), and Figure 10B provides several examples of using radiopaque sutures to provide annulus alignment (axial position or penetration depth).

[0052] 10A is a diagram of an exemplary replacement aortic valve 140 including an expandable frame 142 supporting a tissue valve 144 and a tissue skirt 146. The replacement aortic valve 140 includes suture patterns 148 aligned with each of the commissure posts formed in the expandable frame 142. Alternatively or additionally, the replacement aortic valve 140 also includes suture patterns 150 that are vertically aligned with the commissure posts but located lower, closer to where the replacement aortic valve 140 will contact the native aortic valve annulus upon deployment. The suture patterns 148 and 150 may be formed, for example, by suturing into tissue or by wrapping a radiopaque suture material around the expandable frame 142 itself.

[0053] 10B is a diagram of an exemplary replacement aortic valve 160 including an expandable frame 142 supporting a tissue valve 144 and a tissue skirt 146. The replacement aortic valve 160 includes a first suture pattern 162 extending circumferentially around the replacement aortic valve 160 at a first axial location and a second suture pattern 164 extending circumferentially around the replacement aortic valve 160 at a second axial location axially offset from the first axial location. It will be understood that the replacement aortic valve 160 can include the first suture pattern 162 without the second suture pattern 164. The replacement aortic valve 160 can include the second suture pattern 164 without the first suture pattern 162, depending on which portions of the valve are desired to be visible under fluoroscopy.

[0054] The devices described herein, as well as their various components, may be manufactured according to essentially any suitable manufacturing technique, including molding, casting, machining, etc., or any other suitable technique. Additionally, the various structures may comprise materials commonly associated with medical devices, such as metals, metal alloys, polymers, metal-polymer composites, ceramics, combinations thereof, etc., or any other suitable material. These materials may include transparent or translucent materials to aid in visualization during procedures. Some examples of suitable metals and metal alloys include stainless steels, such as 304V, 304L, and 316LV stainless steels; mild steels; nickel-titanium alloys, such as linear elastic and / or superelastic nitinol; other nickel alloys, e.g., nickel-chromium-molybdenum alloys (e.g., UNS: N06625, such as INCONEL® 625; UNS: N06022, such as HASTELLOY® C-22®; HASTELLOY® Nickel-cobalt alloys (e.g., UNS:N10276 such as C276™, other HASTELLOY® alloys, etc.), nickel-copper alloys (e.g., UNS:N04400 such as MONEL® 400, NICKELVAC™ 400, NICORROS™ 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035 such as MP35-N™), nickel-molybdenum alloys (e.g., HASTELLOY® ALLOY B2™), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, cobalt-chromium alloys, cobalt-chromium-molybdenum alloys (e.g., UNS:R30003, such as ELGILOY®, PHYNOX®), platinum-enriched stainless steels, combinations thereof, and the like, or any other suitable material.

[0055] Some examples of suitable polymers include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN® available from DuPont), polyether block esters, polyurethanes, polypropylene (PP), polyvinyl chloride (PVC), polyetheresters (e.g., ARNITEL® available from DSM Engineering Plastics), ether or ester-based copolymers (e.g., butylene / poly(alkylene ether) phthalates and / or other polyester elastomers such as HYTREL® available from DuPont), polyamides (e.g., DURETHAN® or Elf® available from Bayer), and the like. CRISTAMID™ available from Atochem), elastomeric polyamides, block polyamide / ethers, polyether block amides (PEBA, e.g., available under the trade name PEBAX®), ethylene vinyl acetate copolymer (EVA), silicone, polyethylene (PE), Marlex high density polyethylene, Marlex low density polyethylene, linear low density polyethylene (e.g., REXELL™), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyparaphenylene terephthalamide (e.g., KEVLAR®), polysulfone, nylon, nylon-12 (e.g., EMS American GRILAMID® available from Grillon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxies, polyvinylidene chloride (PVdC), polycarbonates, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites, and the like.

[0056] It will be understood that this disclosure is, in many respects, merely illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps, without exceeding the scope of the disclosure. This may include, to the extent appropriate, using any of the features of one illustrative embodiment in other embodiments. The scope of the invention is, of course, defined in the language in which the appended claims are expressed.

Claims

1. 1. An implantable medical device adapted to be implanted at an implantation site within a vasculature, the implantable medical device being capable of being implanted at the implantation site within the vasculature at two or more locations relative to the implantation site, the implantable medical device comprising: an expandable frame adapted to expand from a collapsed configuration for delivery to an expanded configuration for deployment; and one or more radiopaque markers positioned relative to the expandable frame such that fluoroscopic imaging of the implantable medical device during deployment provides an indication of the position of the implantable medical device relative to the implantation site.

2. 10. The implantable medical device of claim 1, wherein at least some of the one or more radiopaque markers are positioned to provide an indication of the axial position of the implantable medical device relative to the implantation site via fluoroscopic imaging.

3. The implantable medical device of claim 1 or 2, wherein at least some of the one or more radiopaque markers are positioned to provide an indication of the rotational position of the implantable medical device relative to the implantation site via fluoroscopic imaging.

4. The implantable medical device of any one of claims 1 to 3, wherein at least some of the one or more radiopaque markers include radiopaque marker bands crimped onto portions of the expandable frame.

5. The implantable medical device of any one of claims 1 to 3, wherein at least some of the one or more radiopaque markers comprise radiopaque wires wrapped around a portion of the expandable frame.

6. The implantable medical device of any one of claims 1 to 3, wherein at least some of the one or more radiopaque markers comprise radiopaque sutures sewn around a portion of the expandable frame.

7. 1. A replacement heart valve adapted to be implanted within a native heart valve annulus, said replacement heart valve being capable of being implanted in two or more positions relative to said native heart valve annulus, said replacement heart valve comprising:

1. An expandable frame adapted to expand from a collapsed configuration for delivery to an expanded configuration for deployment, the expandable frame comprising: an annular portion adapted to engage the native heart valve annulus when deployed; a plurality of commissure posts adapted to extend above the native heart valve annulus when deployed; an expandable frame including valve material secured to the plurality of commissure posts, the valve material forming a valve leaflet between each of the plurality of commissure posts; one or more radiopaque indicators positioned relative to the expandable frame such that fluoroscopic imaging of the replacement heart valve during deployment provides an indication of the position of the replacement heart valve relative to the native heart valve annulus.

8. The replacement heart valve of claim 7 , wherein at least some of the one or more radiopaque indicators are fixed to at least some of the plurality of commissure posts.

9. 9. The replacement heart valve of claim 7 or 8, wherein the expandable frame includes a plurality of struts, one or more of the plurality of struts adapted to house at least some of the one or more radiopaque indicators.

10. 10. The replacement heart valve of claim 7, wherein one or more of the plurality of struts is formed with a constricted portion adapted to receive a radiopaque marker band therearound.

11. 11. The replacement heart valve of any one of claims 7 to 10, wherein the expandable frame includes a plurality of loops, one or more of the loops adapted to house one or more radiopaque indicators within at least some of the loops.

12. 1. An aortic valve adapted to be implanted within a native aortic annulus, the aortic valve being capable of being implanted in two or more positions relative to the native aortic annulus, the aortic valve comprising:

1. An expandable frame adapted to expand from a collapsed configuration for delivery to an expanded configuration for deployment, the expandable frame comprising: an annular portion adapted to engage the native aortic valve annulus when deployed; a plurality of commissure posts adapted to extend above the native heart valve annulus when deployed; a plurality of stabilizing arches adapted to extend above the plurality of commissure posts; an expandable frame including valve material secured to the plurality of commissure posts, the valve material forming a valve leaflet between each of the plurality of commissure posts; a plurality of radiopaque indicators positioned relative to the expandable frame such that fluoroscopic imaging of the aortic valve during deployment provides an indication of the position of the aortic valve relative to the native aortic valve annulus.

13. 13. The aortic valve of claim 12, wherein at least some of the plurality of radiopaque indicators are fixed relative to the annular portion of the expandable frame adapted to engage the native aortic valve annulus when deployed.

14. The aortic valve of claim 12 , wherein at least some of the plurality of radiopaque indicators are fixed relative to at least some of the plurality of commissure posts.

15. 15. The aortic valve of claim 12, wherein at least some of the plurality of radiopaque indicators are adapted to provide an indication of an insertion depth of the aortic valve relative to the native aortic valve annulus, and at least some of the plurality of radiopaque indicators are adapted to provide an indication of a relative rotational position of the aortic valve relative to the native aortic valve annulus.

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