Patent Description:
The present disclosure relates in general to a heart valve for heart valve replacement and, in particular, to bioprosthetic heart valves. More particularly, the present disclosure relates to methods and devices for facilitating valve-in-valve implantation procedures using radiopaque elements.

When a native heart valve in an individual is diseased or damaged, a bioprosthetic heart valve may be surgically implanted in that individual to replace the native heart valve. At some time after the bioprosthetic heart valve has been successfully implanted and functioning within the individual, the implanted heart valve may become damaged or worn out such that it ceases to function properly. If the implanted heart valve fails to function properly, a new replacement prosthetic heart valve may be surgically implanted to resume normal functions. However, at the point at which the original implanted heart valve needs replacement, patients are often too old and frail for another invasive surgical procedure. For these patients, a less traumatic valve-in-valve procedure (hereinafter referred to as "VIV procedure") may be performed. In a VIV procedure, a new prosthetic heart valve is implanted inside of the surgical heart valve using a minimally invasive transcatheter procedure.

One challenge that arises from VIV procedures is that the diameter of the surgical heart valve limits the size of the transcatheter heart valve that can be implanted inside of it. When the originally implanted surgical heart valve is small (e.g., <NUM> or <NUM> millimeters in diameter), the size of the implanted transcatheter heart valve may be too small to the meet the patient's blood flow requirements, such that the patient suffers from suboptimal hemodynamics. This results in the phenomenon of patient-prosthesis mismatch (hereinafter referred to as "PPM"). PPM has shown to be associated with increased mortality after VIV procedures.

PPM also occurs when patients do not know the size of the valve currently in their body. Given that the lifetime of a surgical valve can be anywhere from <NUM>-<NUM> years, records may have been lost or misplaced within that time period. Implantation of an inappropriately large transcatheter heart valve may result in stent deformation, valvular incompetence, and/or damage to the surrounding tissues. On the other hand, use of an inappropriately small transcatheter heart valve may result in suboptimal hemodynamics. Without knowledge of the exact size of the surgical valve within the patient's body, the physician will have difficulty determining the best size of transcatheter heart valve to replace the surgical valve. A physician will have to make a best estimate about the size of the surgical valve primarily based on the x-rays.

Another challenge presented with VIV procedures is determining the exact position and orientation of the deteriorated surgical valve prior to insertion of the replacement valve. In order to properly position the transcatheter valve within the deteriorated surgical valve, the surgeon must rely on x-rays or fluoroscopy to identify the current position of the surgical valve and the target site for implantation of the transcatheter heart valve.

Thus, knowing the position of the surgical valve within the body prior to the VIV procedure, as well as the size of the valve, is paramount. Current procedures for determining valve position include placing a single wrap of a stainless steel wire around an annular section of the stent which is within the valve cuff. The physician may identify this wire using x-rays/fluoroscopy. (See <FIG>. ) This structure can be insufficient to aid the physician because the wire may not clearly appear on x-rays/fluoroscopy. Additionally, the annular wire interferes with VIV procedures that involve cracking the surgical valve stent prior to inserting the transcatheter valve. Thus, there exists a need for improved devices and methods to aid physicians with identifying the position of a deteriorated surgical valve within a patient's body, as well as with determining the size of the deteriorated valve.

<CIT> describes a resizeable base for cardiovascular valve assembly that is comprised of the resizable valve base and a valve member that is detachably coupled thereto. <CIT> describes stationary intra-annular halo designs for paravalvular leak reduction. <CIT> describes a prosthetic heart valve configured to replace a native heart valve and having a support frame configured to be reshaped into an expanded form in order to receive and/or support an expandable prosthetic heart valve therein is disclosed, together with methods of using same.

According to the present invention, a prosthetic heart valve is provided according to the appended claims.

It is to be noted that the features of the above-described arrangements are not exclusive to each other, and that any one of such features and arrangements can be combined with one or more of the other features and arrangements to arrive at further aspects of the disclosure.

A more complete appreciation of the subject matter of the present disclosure may be realized by reference to the following detailed description and the accompanying drawings, in which:.

The invention relates to a prosthetic heart valve as illustrated on <FIG>, <FIG>, <FIG>.

As used herein in connection with a prosthetic heart valve, the term "inflow end" refers to the end of the heart valve through which blood enters when the valve is functioning as intended, and the term "outflow end" refers to the end of the heart valve through which blood exits when the valve is functioning as intended. As used herein, the terms "generally," "substantially," and "about" are intended to mean that slight deviations from absolute are included within the scope of the term so modified. Like numbers refer to similar or identical elements throughout. When used herein in the context of a prosthetic heart valve, or a component thereof, the circumferential direction refers to the direction extending along the circumference of the prosthetic heart valve.

<FIG> is a perspective view of a frame <NUM> for a prosthetic heart valve according to the prior art. Frame <NUM> is a component of a surgical heart valve, i.e., a prosthetic heart valve that is implanted in a patient through open chest, open heart surgery. Generally, certain embodiments of the present disclosure include frames similar to frame <NUM>, although each embodiment includes a different structural radiopaque feature that enables one to view the exact location of the commissure posts and/or annulus of the frame, in vivo, as will be described in further detail below. The ability to identify the exact location of the frame's commissure posts and/or annulus, as well as determine the size of the already-implanted valve, enables a more precise selection of a replacement transcatheter valve prior to a VIV procedure, as well as the implantation of the transcatheter valve within the surgical heart valve during a VIV procedure.

Referring to <FIG>, frame <NUM> is a hollow, non-collapsible annular stent-like structure. Frame <NUM> is referred to as "hollow" because the interior region <NUM> that is bounded by the annular structure is open. Frame <NUM> is typically made of an acetal copolymer material, including polyetheretherketone or acetal. The copolymer frame may be manufactured by injection molding, but other methods of manufacturing may be utilized, including machining and laser cutting a plastic tube or the like.

Because the surgical heart valve being discussed is a tricuspid valve (e.g., for use in replacing a patient's aortic valve), frame <NUM> has three commissure posts 106a, 106b, and 106c that may be equally spaced from one another around the circumference of the frame. Each commissure post stands up from the annularly continuous base <NUM> of the frame. The base includes a lower-most, blood-inflow edge <NUM>. As used throughout the present description, the terms lower, below, upper, above, bottom and top refer to a frame oriented as shown in <FIG>, <FIG>, <FIG>, with <FIG> representing a one-third portion only of frame <NUM>. Inflow edge <NUM> may be scalloped as one proceeds around the frame to approximately match the natural scallop of the native valve annulus. In particular, the scallop of inflow edge <NUM> may rise in the vicinity of each commissure post <NUM>, and may fall between each annularly adjacent pair of commissure posts.

Frame <NUM> also includes an annularly continuous blood-outflow edge <NUM> (which merges with and becomes part of each commissure post <NUM>). Outflow edge <NUM> may be much more deeply scalloped than inflow edge <NUM>. In particular, outflow edge <NUM> rises adjacent each commissure post <NUM> (actually merging into each commissure post), and falls between each annularly adjacent pair of commissure posts.

Inflow edge <NUM>, outflow edge <NUM>, and the flexibility of frame <NUM> are designed to help ensure proper opening and coaptation of the finished valve in use. (Coaptation is the coming together of the free edges of the valve leaflets when the valve is closed. ) Frame <NUM> is further designed to decrease maximum stresses in the frame during use, which gives the finished valve an increased safety factor.

A plurality of openings in the form of apertures and slots may be present in frame <NUM>, at least some of which may be used to attach fabric and/or tissue over frame <NUM>. The apertures and slots may be used to pass needles through frame <NUM> when attaching the fabric and/or tissue to the frame, as discussed in connection with <FIG>. The apertures may extend along the outflow edge of each of the commissure posts 106a, 106b, 106c. For example, apertures 112a-<NUM> are shown adjacent outflow edge <NUM> of commissure post 106a in <FIG>.

Geometric openings are also provided within frame <NUM> in order to increase the flexibility of the frame and withstand fatigue, particularly as the valve leaflets open and close during use. As shown in <FIG>, a plurality of base openings 116a, 116b, 116c, 116d, 116e, 116f, <NUM>, <NUM>, 116i, 116j, <NUM>, <NUM> extend around the base <NUM> of frame <NUM>. The base openings may be provided between each pair of adjacent commissure posts <NUM>. For example, four base openings 116c, 116d, 116e, 116f may extend between commissure posts 106a and 106b. Each base opening includes a respective bottom edge 115a-<NUM> and a respective top edge 117a-<NUM>. Bottom edges <NUM> may extend generally parallel to inflow edge <NUM>. Commissure posts 106a-106c further include respective post slots 114a-114c that extend along the length of the respective commissure posts.

As shown, an annular wire <NUM> may extend around the base <NUM> of frame <NUM>, and its ends may be tied off with a twist <NUM>. As shown in <FIG>, the ends of annular wire <NUM> may be intertwined or twisted together. Twist <NUM> may appear at any position along base <NUM>, depending on where the wrapping of annular wire <NUM> begins and ends. In the example shown, twist <NUM> is at the same position as the commissure post 114a.

<FIG> illustrates a prior art surgical heart valve <NUM> formed from frame <NUM>. Surgical heart valve <NUM> may include a sewing cuff <NUM> that extends around base <NUM> and overlies annular wire <NUM>, as well as one or more layers of fabric and/or biological tissue covering the sewing cuff and frame <NUM>. For example, a ring (not shown) formed of silicone or another appropriate material may be positioned around the outside of base <NUM> and may follow the scalloping of inflow edge <NUM>. A layer of fabric (not shown) may then be applied tightly over the inside surface of frame <NUM>, over the outside surface of the frame, and around the exposed surfaces of the ring so that the fabric layer conforms to the outflow edge <NUM> of the frame. Sutures may be used to hold the fabric layer to the underlying structures.

Optionally, a fabric sleeve (not shown) may be sutured or otherwise attached to cover the top of each commissure post <NUM> prior to the application of the fabric layer. These fabric sleeves may help reduce the possibility that the tips of the commissure posts will poke through the fabric layer or any subsequently applied layers.

A layer of biological tissue <NUM> may then be applied over the fabric layer both inside and outside of frame <NUM> and may attach to the fabric-covered ring. The biological tissue may be mammalian pericardial tissue, such as bovine, porcine or equine pericardium, or other appropriate types of tissue. The tissue layer may be secured to the underlying structure by sutures. Additional tissue, preferably of the same type, may be cut to shape and assembled to the interior of the covered frame to form leaflets <NUM>. Alternatively, leaflets <NUM> can be formed from animal leaflets, including a bovine cusp or porcine cusp. The lower edges of the leaflets may follow the scalloped shape of inflow edge <NUM>. All three leaflets shown in <FIG> may be formed from a single integral sheet of tissue. Rather than biological tissue, leaflets <NUM> and the outer covering of surgical heart valve <NUM> may be formed from a biocompatible polymer, or from a tissue/polymer combination. The various layers that may be applied to frame <NUM> to form surgical heart valve <NUM> are more fully described in <CIT>.

The surgical heart valves in accordance with a first embodiment of the present disclosure may be similar to heart valve <NUM> described above, and may include the same fabric, tissue and/or polymer leaflets and covering layers, but may be modified to include features that allow for portions of the valve to be more easily seen and identified on an x-ray/fluoroscopy before and during a VIV procedure.

Referring to <FIG>, a frame <NUM> is shown with the same underlying structure as frame <NUM> in <FIG>, but without an annular wire adjacent the base <NUM>. To assist the surgeon in better identifying the location of frame <NUM>, and particularly, the positions and orientations of the commissure posts within a human body, frame <NUM> further includes at least one element having radiopaque properties positioned on one or more of the commissure posts. Such radiopaque elements can block radiation, rather than allowing radiation to pass through them, which causes the radiopaque element to be visible under a fluoroscope or on x-rays.

The radiopaque element may be a metal wire formed from stainless steel, but the metal wire may be comprised of any radiopaque material, including other metals, including titanium, or aluminum, or metal alloys. The wire may alternatively be a radiopaque clad wire that incorporates a metal, such as gold, platinum-iridium, tantalum, tantalum-tungsten and other metals or metal alloys bonded to a high strength wire, such as stainless steel or nitinol wire. Examples of radiopaque clad wire include tantalum clad stainless steel and gold clad nitinol.

The wire may have any desired diameter, but in one example can range in size from about. <NUM> to about <NUM> in diameter. In other examples, the wire may have a diameter greater than about <NUM> or less than about. It is to be appreciated that the wire must not be too thick or wrapped too many times around any one of the commissure posts 1106a, 1106b, 1106c. Otherwise, the wire-wrapped portions of the frame become rigid and interfere with the coaptation of the valve leaflets.

In one example, a radiopaque wire may be positioned towards the respective tips 1120a, 1120b, 1120c of commissure posts 1106a, 1106b, 1106c. With specific reference to commissure post 1106a, as shown in <FIG>, <FIG>, radiopaque wire 1118a includes a first end 1124a, a second end 1126a, and a main body wrapped around the tip 1120a of commissure post 1106a. Radiopaque wire 1118a may extend through post slot 1114a, around the tip 1120a of commissure post 1106a, and back around through post slot 1114a. The radiopaque wire 1118a may be wrapped around the tip 1120a of commissure post 1106a and through post slot 1114a any number of times, but in this example, wire 1118a wraps around the commissure post tip four times, such that four individual wire wraps or rays 1122a, 1122b, 1122c, 1122d are seen across the outer surface <NUM> of frame <NUM>. In other examples, the wire may be wrapped around the commissure post tip fewer than four times or as little as one time, as well as greater than four times, such as five or six times.

Wire 1118a may be secured to frame <NUM> in any number of ways. In the illustrated example, prior to wrapping, an initial excess length 1125a of wire 1118a adjacent first end 1124a may be provided that is not wrapped around commissure post 1106a. Once radiopaque wire 1118a is wrapped around commissure post 1106a the desired number of times, another excess length 1127a of wire 1118a adjacent second end 1126a may be provided. The excess lengths 1125a, 1127a may be positioned adjacent one another and then tucked underneath the main body of wire 1118a. In this example, the first and second ends are not directly secured to each another and are instead tucked underneath rays 1122a, 1122b, 1122c, 1122d against the outer surface <NUM> of frame <NUM>. <FIG> shows a side view of wrapped wire 1118a illustrating that this configuration allows for a narrow profile that closely matches the profile of frame <NUM>. This allows for a less bulky configuration and one that can aid in manufacturability.

Alternate techniques for securing the wire to frame <NUM> are also contemplated herein. <FIG> illustrate alternative examples in which the first and second ends of the wire are secured to one another. With reference to <FIG>, the excess length 1125a' adjacent the first end 1124a' of wire 1118a' and the excess length 1127a' adjacent the second end 1126a' of the wire may be twist tied or intertwined together. The resulting twisted section 1129a' may be folded adjacent wire rays 1122a', 1122b', 1122c', 1122d'. As shown, twisted section 1129a' may be positioned adjacent ray 1122d'. Alternatively, as shown in <FIG>-6D, the excess lengths 1125a" and 1125b" of wire 1118a" may be intertwined so that the twisted section 1129a" overlaps the main body or rays 1122a", 1122b", 1122c", 1122d" of the wire in a diagonal direction. Alternatively, as shown in <FIG>, the twisted section 1129a‴ may be positioned within the slot 1114a‴ of commissure post 1106a, such that the twisted section 1129a‴ is positioned directly below rays 1122a‴, 1122b‴, 1122c‴, 1122d‴.

<FIG> illustrates another technique and example for securing the wire to the frame, in which the ends of the wire remain free ends that are not secured to one another. As shown, a first end 1124aʺʺ and a second end 1124bʺʺ of the wire 1118ʺʺ are tucked underneath or below the wire wraps or rays 1122aʺʺ, 1122b"", 1122cʺʺ, and 1122dʺʺ. This can help to prevent the first and second ends of the wire 1118ʺʺ from protruding beyond the wire rays 1122a"", 1122b"", 1122cʺʺ, and 1122dʺʺ, as well as through the fabric and/or tissue that will be attached to the commissure posts 1106aʺʺ of the frame.

The wire 1118ʺʺ can be wrapped in any way that will ensure the first end 1124aʺʺ and the second end 1124bʺʺ are tucked underneath or below one or more rays. In one example, an excess length 1118a of wire <NUM>"", including the first end 1124a"", may be positioned at the front and outer surface <NUM>"" of the commissure post 1106a"". The length of wire 1118ʺʺ can then be wrapped around the rear of the commissure post 1106aʺʺ and back through the post slot 1114aʺʺ of the commissure post 1106aʺʺ so that the wire 1118ʺʺ overlies the first end 1124aʺʺ. The wire 1118ʺʺ can be wrapped any number of times around the commissure post 1106a"" and back through the post slot 1114a"". In this example, wire 1118ʺʺ is wrapped around and back through the post slot 1114aʺʺ five times, so as to create four wire rays 1122a" ", 1122b"", 1122c" ", and 1122dʺʺ that both extend through the post slot 1114a"" and over the tip <NUM>"" of the commissure post 1106a"". Once the wire has been wrapped the desired number of times, an excess length 1118b of wire 1118ʺʺ adjacent the second end 1124bʺʺ can be tucked or placed underneath each of the four wire rays 1122aʺʺ, 1122b"", 1122c"", and 112d"". As shown, the second end 1124bʺʺ can be positioned directly below the first end 1124aʺʺ or closer to the inflow end (not shown) of the stent. As a result of this construction, both the first and second ends 1124a"", 1124bʺʺ will be positioned between the four wire rays 1122a"", 1122b"", 1122c"", and 1122dʺʺ and the frame.

Radiopaque wire may also be wrapped around more than one commissure post. For example, with reference back to <FIG>, wire 1118b may be wrapped around the tip of commissure post 1106b and wire 1118c may be wrapped around the tip of commissure post 1106c. For ease of discussion, only radiopaque wire 1118a has been discussed, but it is to be understood that a radiopaque wire may be similarly wrapped around the other commissure posts 1106b and 1106c, and that the same attributes of the wire and techniques may be applied.

It is to be further appreciated that the radiopaque element used to form the arrays or wire wraps need not be limited to a radiopaque wire, but may include any radiopaque elements that may extend around, along, within or adjacent the commissure post. For example, one or more individual flexible and radiopaque bands may be clipped over the tips of the commissure posts and positioned directly adjacent one another to form the arrays on the commissure posts.

Frame <NUM> may be formed from a polymeric material, including an injection molded monolithic polymer. As used herein, the term "monolithic" refers to a structure that is formed entirely from a polymeric material, rather than to structures that may have a non-polymeric core and a polymeric coating, or a polymeric core and a non-polymeric coating. The term "monolithic" is not intended to be limited to structures formed from a single polymeric material. Thus, "monolithic" polymer structures include those that may be formed from a mixture of different polymeric materials, as well as those that may include layers or regions formed from the same or different polymeric materials. Moreover, although injection molding is a preferred method for manufacturing frame <NUM>, it is contemplated that the stent may be formed by other techniques known in the art. For example, stent <NUM> may be formed by machining or laser cutting a tube of polymeric material in a manner similar to the manner in which the prior art metal stents are formed.

Various alternative configurations may be used to provide a visual indicator on an x-ray or fluoroscope to identify the position and orientation of the commissure posts within a human body. <FIG> illustrate alternative structures that allow a radiopaque material to extend along at least a portion of a commissure post. With reference first to <FIG>, frame <NUM> is similar to frame <NUM> described above, but further includes additional apertures along and around the length of commissure post slot 1214a which may be used to receive radiopaque elements or components to help secure a radiopaque element to the commissure post. As shown, three apertures 1232a, 1232b, 1232c are positioned to the left of commissure post slot 1214a, three apertures 1232e, 1232f, <NUM> are positioned to the right of the commissure post slot, a single aperture 1232d is provided adjacent the top of the commissure post slot, and a single aperture <NUM> is provided adjacent the bottom of the commissure post slot. Apertures 1232a-h may be any size, but are preferably sized to be slightly larger than the diameter of at least one radiopaque wire to be woven into the apertures.

A radiopaque wire, such as the previously described radiopaque wire 1118a, may be weaved into and out of each of the apertures. With reference to <FIG>, an enlarged fragmentary front view of a one-third section of frame <NUM>, and <FIG>, a rear view of what is shown in <FIG>, radiopaque wire <NUM> extends along and around the length of commissure post slot 1214a. A first end <NUM> of radiopaque wire <NUM> may be tied into a knot <NUM> at the rear surface <NUM> of frame <NUM> (<FIG>) at aperture 1232b and then weaved through the rear and out of the front of aperture 1232b, and then into the front and out of the rear of aperture 1232c. Radiopaque wire <NUM> may be continuously weaved into and out of the remaining apertures 1232d-h. Second end <NUM> of radiopaque wire <NUM> may be passed through aperture 1232a and tied into a knot <NUM> or secured to frame <NUM> by any means. In one alternative example, the first and second ends <NUM>, <NUM> of wire <NUM> may extend toward one another from apertures 1232b, 1232a, respectively, and may be secured to one another, such as by tying the ends together or by tying second end <NUM> to knot <NUM>. Instead of securing the first end <NUM> and second end <NUM> together at rear surface <NUM> of frame <NUM>, the first and second ends <NUM>,<NUM> can be secured together at the opposed front surface (<FIG>) of frame <NUM>. In such embodiment, knot <NUM> is positioned away from the leaflets, which can help to mitigate leaflet damage due to use over time.

The radiopaque wire may be weaved through the apertures more than one time, if desired, which will increase the visibility of the radiopaque wire in an x-ray or fluoroscope. With reference to <FIG> and example frame <NUM>, a first radiopaque wire 1318a and a second radiopaque wire 1318b are weaved through apertures 1332a-<NUM>, such that there are two adjacent wires extending into and out of each aperture. As in the prior example, the first end can be tied into a knot (not shown) at the rear surface. Radiopaque wires may be weaved through apertures 1332a-<NUM> any number of times, provided that the collective diameter of the wires extending through the apertures does not exceed the diameter of any one of the apertures through which the wires extend. The second ends may also be tied off into a knot in the rear. Increasing the number of wires may help to improve the visibility of the commissure posts on a scan.

Alternatively, weaving of the first and second wires may be staggered so that radiopaque wire is seen extending between each of the apertures from both sides of the frame, as opposed to between pairs of apertures spaced apart from one another, as in the previous example of <FIG>. Referring to <FIG>, a fragmentary front view of a one-third section of frame <NUM>, wire 1418a is shown extending around annular slot 1414a and between apertures 1432b-1432c, apertures 1432d and 1432e, 1432f-<NUM>, and apertures <NUM>-1432a. As in the previous example, the first end 1424a of first wire 1418a may be tied in a knot <NUM> at the rear surface <NUM> of aperture 1432b (or alternatively tied in a knot at the front surface of aperture 1432b shown in <FIG>). The first end 1424b of a second radiopaque wire 1418b may be tied into a knot <NUM> at the rear surface <NUM> of aperture 1432a and weaved into and out of alternating openings 1432a-b, 1432c-1432d, 1432e-1432f, and <NUM>-<NUM>, also as seen on the front surface of frame <NUM> shown in <FIG>.

The thickness of the wire may alternatively or additionally be varied to increase visibility of the commissure posts on x-rays, fluoroscopes or the like. <FIG> illustrates the use of a wire <NUM> having a diameter that is only slightly smaller than the diameter of the wire apertures 1532a through <NUM> in frame <NUM>. Wire <NUM> is weaved into and out of each of the apertures 1532a - <NUM>, as in the previous examples. An example wire may have a diameter of about <NUM>, but a wire with a diameter that is greater than or less than <NUM> may be used.

Radiopaque objects or markers may be attached to the commissure posts, or to any other portion of the frame. <FIG> illustrates a fragmentary front view of a one-third section of an alternative frame <NUM> that includes at least two wire apertures 1632a and 1632b to the left of commissure post slot <NUM>, and two wire apertures 1632c and 1632d to the right of the commissure post slot. A radiopaque washer <NUM> may be attached to the frame toward the top edge of commissure post slot <NUM>. Washer <NUM> may be a round washer having a diameter that does not extend beyond the peripheral edge P of frame <NUM>. Washer <NUM> may be attached directly to frame <NUM> by any means. In this example, a wire or sutures may be threaded through apertures 1632a, 1632b and 1632c, 1632d to secure washer <NUM> to commissure post <NUM>. In other examples, washer <NUM> may instead be attached directly to the fabric that will be provided around frame <NUM> during manufacture of the surgical heart valve. In still other examples, washer <NUM> may be attached to commissure post <NUM> in a variety of ways, including the use of a wire, suture, or other means of attachment that may extend around the commissure tip <NUM>, through the opening of the washer, and through commissure post slot <NUM>.

The radiopaque objects or markers may take on any variety of shapes, sizes, and forms. <FIG> illustrates an alternative object attached to a frame. In this example, an elongated radiopaque bead <NUM>' is attached to frame <NUM>. Any size and style of bead may be used. In this example, bead <NUM>' includes a bore or lumen (not shown) extending through its length. A securing element, such as a wire, suture or the like, may extend through the bore of bead <NUM>' and through the respective apertures 1732a, 1732b on opposed sides of the bead.

Radiopaque elements may additionally or alternatively be provided around the base of the frame annulus to help identify the position of the base within a patient's body. <FIG> is a perspective view of a frame <NUM>, while <FIG> is a fragmentary front view of a one-third section of the frame. Frame <NUM> is similar to frame <NUM> described above, but further includes an annular wire <NUM> that extends circumferentially around the entire base <NUM> of the frame. In this example, annular wire <NUM> is a single length of wire that is continuously wrapped around the base of frame <NUM> four times. A first wire wrap 2018a, a second wire wrap 2018b, a third wire wrap 2018c, and a fourth wire wrap 2018d extend around base <NUM>.

The wire wraps <NUM> extending around the base <NUM> of frame <NUM> can be provided in a variety of patterns. As shown, each wrap <NUM> may be evenly spaced between inflow edge <NUM> and each of the respective bottom edges 2015a-d of base openings 2016a-2016d. Each wire wrap may have a shape or profile matching the scalloped shape of inflow edge <NUM>. In other examples, the annular wire wraps may be more closely spaced together or spaced further apart.

As shown in <FIG>, an excess length <NUM> at the first end <NUM> of wire <NUM> may be provided prior to wrapping the wire. The excess length <NUM> may extend in two directions, a first upwards direction toward the bottom edge 2015a of base opening 2014a and a second perpendicular direction in which wire <NUM> begins wrapping around the base <NUM> of frame <NUM>. The second, third and fourth wire wraps 2018b-d may be wrapped over excess length <NUM> adjacent first end <NUM> or underneath the excess length.

Wire <NUM> may be a single wire that continuously extends around the base <NUM> of frame <NUM>, with the wire having a first end <NUM> and a second end <NUM>. When the wrapping of the wire begins, the first wrap 2018a may be positioned around base <NUM> closest to inflow edge <NUM>. A second wire wrap 2418b, third wire wrap 2418c, and fourth wire wrap 2418d will successively extend around the base. To allow a single wire to continuously extend around base <NUM>, a transitional length of wire may extend between each row of wire wrapping. For example, a wire transition T1 may extend between first wire wrap 2018a and second wire wrap 2018b; a wire transition T2 may extend between the second wire wrap and third wire wrap 2018c; and a wire transition T3 may extend between the third wire wrap and fourth wire wrap 2018d. Each of the transitions is a length of wire extending in a vertical or upwards direction. It is to be appreciated that the length of wire between any two wraps, as well as the specific transition between any two wire wraps, may be any desired shape or line that allows one continuous wire to be wrapped around base <NUM> of frame <NUM>. Additionally, transitions T1, T2, T3 need not all be at the same annular position around base <NUM>, but may be at staggered positions around the base.

When the desired number of wraps have been made, in this example four wraps, the first and second ends <NUM>, <NUM> may be intertwined together in the manner previously described to secure wire <NUM> to frame <NUM>. In alternative examples, second end <NUM> may include an excess length of wire so that the second end extends toward the first end <NUM> for securing the first and second ends together. Similarly, both the first end <NUM> and the second end <NUM> may include excess lengths of wire to allow the first and second ends to meet and be secured or tied together at a position between the first wire wrap 2018a and the last wire wrap 2018d.

In another example, additional apertures may be provided along the annular base <NUM> of frame <NUM> to accommodate one or more wires extending therethrough. With reference to <FIG>, apertures 2150a-q extend around base <NUM> between inflow edge <NUM> and respective bottom edges 2115a-d of base openings 2116a-d. The apertures extend around the entirety of base <NUM>, but for ease of discussion, only the apertures visible in <FIG> and <FIG> are shown. Apertures 2150a-<NUM> follow the scallop-shaped contour of the inflow edge <NUM> and extend around the entire circumference (not shown) of frame <NUM>. As in the example of <FIG>-9C, wire <NUM> may be weaved into and out of each of the apertures. One end (not shown) of wire <NUM> may be tied in a knot or otherwise secured to the inside of frame <NUM> as the second end (not shown) is threaded into and out of each of the apertures. For example, the second end will be threaded in from the rear and out from the front of aperture 2150a; in from the front and out from the rear of aperture 2150b; in from the rear and out from the front of aperture 2150c; in from the front and out from the rear of aperture 2150d; in from the rear and out from the front of aperture 2150e; in from the front and out from the rear of aperture 2150f; in from the rear and out from the front of aperture <NUM>; in from the front and out from the rear of aperture <NUM>; in from the rear and out from the front of aperture 2150i; in from the front and out from the rear of aperture 2150j; in from the rear and out from the front of aperture <NUM>; in from the front and out from the rear of aperture <NUM>; in from the rear and out from the front of aperture <NUM>; in from the front and out from the rear of aperture 2150n; in from the front and out from the rear of aperture 2150o; in from the rear and out from the front of aperture 2150p; and in from the front and out from the rear of aperture 2150q. Wire <NUM> may extend continuously through the remaining apertures (not shown) positioned around the base <NUM> of frame <NUM>. The second end may be tied in a knot behind any of the apertures or may be secured to frame <NUM> using any known means. In other examples, instead of one continuous wire extending around the entirety of base <NUM>, two or more segments of wire may be separately threaded into and out of the apertures around the base.

Apertures 2150a-l may be positioned at an equal distance between inflow edge <NUM> and the respective bottom edges 2115a-d of base openings 2116a-d. In other examples, apertures 2150a-l may be positioned closer to base openings 2116a-d or, alternatively, closer to inflow edge <NUM>. In still other examples, the locations of apertures 2150a-l may vary relative to one another, such that some may be closer to inflow edge <NUM> than others. Additionally, there may be multiple rows of apertures, namely, two or more rows of apertures.

Any number of wires may be threaded through the apertures, provided the diameters of the respective wires can fit through the respective apertures. As shown in <FIG>, frame <NUM> includes apertures 2250a - <NUM>. A first wire 2218a may be threaded through apertures 2250a-<NUM>, as discussed with regard to <FIG>, as may a second wire 2218b. Wires 2218a and 2218b may have a combined diameter that is less than the diameter of the apertures. Wires 2218a and 2218b may be threaded through the apertures in tandem, i.e., both wires may be threaded into the front and out from the rear of the same apertures. Alternatively, the wires may be offset by an aperture such that one wire is threaded into the front and out from the rear of one aperture, while the other wire is threaded into the front and out from the rear of the next adjacent aperture. Thus, in this latter embodiment, the wires will alternately be threaded into the front and out from the rear of every aperture, as discussed in connection with <FIG>. This may allow for the appearance of a continuous wire extending around base <NUM>. In still other arrangements, more than two sets of wires may be threaded through the apertures.

As previously discussed, during a TAVR procedure, some surgeons choose to crack the existing surgical valve prior to insertion of the replacement transcatheter valve. Cracking is not possible or is made more difficult when annular wire is wrapped around the circumference of the frame and the ends of the annular wire are tied together or secured to the frame in a way that makes it difficult to expand the diameter and size of the frame. To enable a surgeon to crack the frame, while still providing a structure that will enable the base to be visible on a fluoroscope or x-ray, the first and second ends of the wire may be left as free ends that are not attached or secured to one another, or may be very loosely attached to one another or to the frame. Some examples are discussed below.

<FIG> is a fragmentary front view of a one-third section of a frame <NUM> showing wire <NUM> extending around the frame. It is to be appreciated that in a preferred example, wire <NUM> extends around the entire periphery or circumference of frame <NUM>, but only a one-third section is shown for ease of discussion. Wire <NUM> is positioned between the inflow edge <NUM> and bottom edges 2315a-d of base openings 2316a - 2316d. The first free end <NUM> of wire <NUM> is shown at a position below commissure post <NUM>. Wire <NUM> may be wrapped around the circumference of frame <NUM> in a flattened helical or looped pattern until reaching the second free end <NUM> of the wire.

Any number of circular loops may be provided along each one-third portion of frame <NUM>. In this example, ten circular loops H1-H10 are positioned adjacent inflow edge <NUM>. The circular loops are continuous, with the end of one loop extending into the start of the next loop. In alternative examples, circular loops may be provided on only a one-third section of frame <NUM>, or only one or two circular loops may be provided on frame <NUM>. In other examples, the loops may take on any shape, such as square and triangular. Similarly, instead of loops, excess lengths of wire may be wrapped around the frame <NUM> in any other shape or form so as to allow for expansion of the wire when frame <NUM> is expanded.

The circular loops may be evenly spaced apart from one another by a pre-set distance X, depending on the desired number of circular loops to be provided on frame <NUM>. In other examples, the pre-set distance X between each circular loop may be increased or decreased, or the pre-set distance may vary between the loops rather than being uniform.

Once wire <NUM> has been wrapped around the entire circumference of base <NUM>, first free end <NUM> and second free end <NUM> of wire <NUM> remain spaced apart from one another. They are not intertwined or otherwise secured together. It is to be appreciated that even though the first and second free ends <NUM>, <NUM> of wire <NUM> are not secured together, the properties of the wire, such as the combination of strength and ductility, enable the wire to maintain its shape and position around the base, as well as remain releasably secured and attached to frame <NUM>. Additionally, during preparation of the valve, a cuff (<FIG>) will extend over base <NUM> of frame <NUM> to help keep wire <NUM> in position.

During a TAVR procedure, a previously implanted surgical valve having frame <NUM> may be cracked by expanding a balloon or other expandable structure within the interior of the valve. During such expansion, the circular loops H in wire <NUM> may get smaller as the wire "stretches" along with frame <NUM>. As a result of coiled loops H, wire <NUM> will not inhibit the expansion of frame <NUM>, enabling both greater ease in cracking the frame and greater visibility of the frame during surgery.

<FIG> illustrates another example which is similar to <FIG>, except that the first end <NUM>' and second end <NUM>' are secured together. <FIG> is a fragmentary front view of a one-third section of a frame <NUM>' showing wire <NUM>' extending around the frame. It is to be appreciated that in a preferred example, wire <NUM>' extends around the entire periphery or circumference of frame <NUM>', but only a one-third section is shown for ease of discussion. Wire <NUM>' is positioned between the inflow edge <NUM>' and bottom edges 2315a'-d' of base openings 2316a' - 2316d'. The first end <NUM>' of wire <NUM>' is shown at a position below commissure post <NUM>'. Wire <NUM>' may be wrapped around the circumference of frame <NUM>' in a flattened helical or looped pattern until reaching the second end <NUM>' of the wire.

Any number of circular loops may be provided along each one-third portion of frame <NUM>'. In this example, ten circular loops H1'-H10' are positioned adjacent inflow edge <NUM>'. The circular loops are continuous, with the end of one loop extending into the start of the next loop. In alternative examples, circular loops may be provided on only a one-third section of frame <NUM>', or only one or two circular loops may be provided on frame <NUM>'. In other examples, the loops may take on any shape, such as square and triangular. Similarly, instead of loops, excess lengths of wire may be wrapped around the frame <NUM> in any other shape or form so as to allow for expansion of the wire when frame <NUM>' is expanded.

The circular loops may be evenly spaced apart from one another by a pre-set distance X', depending on the desired number of circular loops to be provided on frame <NUM>'. In other examples, the pre-set distance X' between each circular loop may be increased or decreased, or the pre-set distance may vary between the loops rather than being uniform.

Once wire <NUM>' has been wrapped around the entire circumference of base <NUM>', first 'end <NUM>' and second end <NUM>' of wire <NUM>' may be secured to one another. In one example, as previously disclosed, they may be intertwined with one another or otherwise secured together. It is to be appreciated that even though the first and second ends <NUM>', <NUM>' of wire <NUM>' are not secured together, the properties of the wire, such as the combination of strength and ductility, enable the wire to maintain its shape and position around the base, as well as remain releasably secured and attached to frame <NUM>'.

As noted above, during a TAVR procedure and expansion of the frame, the circular loops H' in wire <NUM> may get smaller as the wire "stretches" along with frame <NUM>. Even though first and second <NUM>' and <NUM>' are secured together, as a result of coiled loops H, wire <NUM> will not inhibit the expansion of frame <NUM>, enabling both greater ease in cracking the frame and greater visibility of the frame during surgery. Additionally, during preparation of the valve, a cuff (<FIG>) will extend over base <NUM> of frame <NUM> to help keep wire <NUM> in position. With the first and second ends <NUM>', <NUM>' secured together, this can help to prevent the first and second ends <NUM>', <NUM>' from piercing through the cuff.

<FIG> illustrate another example frame <NUM> in which the first and second ends of a wire are not secured together and remain free ends. The overall configuration is similar to the configuration shown in <FIG>, except that the first free end <NUM> and second free end <NUM> of wire <NUM> are not secured to one another and spaced apart from one another to enable the frame to expand during a TAVR procedure. As shown in this example, wrapping of wire <NUM> begins with first free end <NUM> at a position closest to inflow edge <NUM>. Wire <NUM> is wrapped in a horizontal direction around base <NUM> of frame <NUM> and generally follows the scalloped shape of inflow edge <NUM>. As with wire <NUM> in <FIG>, a single wire continuously extends around base <NUM> so that there is a first wire wrap 2418a, a second wire wrap 2418b, a third wire wrap 2418c, and a fourth wire wrap <NUM>. With reference to <FIG>, there is a length of wire that extends between each wire wrap to allow for a transition from one row or wire wrap to the next. As shown, there is a wire transition T5 between first wire wrap 2418a and second wire wrap 2418b; a wire transition T6 between second wire wrap 2418b and third wire wrap 2418c; and a wire transition T7 between third wire wrap 2418c and fourth wire wrap 2418d. Wire transitions T5-T7 are each lengths of wire that extend upward in a vertical direction, but it is to be appreciated that the transitions between any two wire wraps may be any desired shape or line that enables one continuous wire to be wrapped around the base <NUM> of frame <NUM>.

After wire <NUM> has been wrapped around base <NUM>, the second free end <NUM> of the wire is not secured or tied to the first free end <NUM> of the wire or to frame <NUM>. As a result, wire <NUM> will be free to expand and will not inhibit the expansion of frame <NUM> when cracking is desired.

With reference to another example shown in <FIG>, frame <NUM> has a configuration similar to that of frame <NUM> shown in <FIG>, and includes first through fourth wire wraps 2518a-2518d extending in a horizontal direction between inflow edge <NUM> and the bottom edges 2515a--2515d of base openings 2516a-2516d. Frame <NUM> differs from frame <NUM> by including a fifth wire wrap 2518e that extends around one or more of the annular wraps 2518a-2518d. As shown, fifth wire wrap 2518e extends over the first through fourth wire wraps 2518a-2518d in a sinusoidal pattern around the entirety (not shown) of base <NUM>. This may further help to secure wire <NUM> to frame <NUM> prior to a cuff being provided thereon. Additionally, the first free end <NUM> and the second free end <NUM> of wire <NUM> are not attached to one another or to frame <NUM>. The fifth wire wrap 2518e may take any variety of shapes or overlapping patterns, and may extend over a fewer number of the wire wraps, such as two or three wire wraps. In another example, fifth wire wrap 2518e may be weaved over and under any number of annular wire wraps to releasably secure wire <NUM> to frame <NUM>.

The wires in <FIG>, <FIG>, and <FIG>, or any example in which the ends of the wire are not secured to each other, may be further secured adjacent the respective frames by the addition of the cuff and fabric overlying the frame during formation of the valve. The cuff and fabric will secure the wire to the frame. Alternatively, the wire may be weaved into the fabric or cuff that will overlie the frame.

Another alternative combination in which radiopaque elements are positioned on the base <NUM> of a frame is illustrated in <FIG>, a one-third section of frame <NUM>. As shown, a radiopaque wire <NUM> is provided at the base <NUM> of frame <NUM> in the form of a C-wrap <NUM>. The C-wrap <NUM> extends around a portion of the circumference of base <NUM> between the inflow edge <NUM> of frame <NUM> and base openings 2616a-2616d. As shown, in this example, the C-wrap includes a first wrap 2618a, a second wrap 2618b, a third wrap 2618c, and a fourth wrap 2618d that extend around the base <NUM>. The first looped end 2676a and the second looped end 2676b of the C-wrap <NUM> can be joined together by a suture <NUM>. For example, the suture <NUM> can be wrapped through the first and second looped ends 2676a, 2676b several times to secure the C-wrap <NUM> against the frame <NUM> and in this example arrangement, the suture <NUM> is wrapped three times to secure the C-wrap. In other examples, the suture can be wrapped around one time, or more than one time. <FIG> shows an enlarged view of the portion of the C-wrap <NUM> and the suture <NUM> extending through the first looped end 2676a of the C-wrap <NUM>.

The C-wrap arrangement allows for the C-wrap, which in this example includes each of the first through fourth wire wraps 2618a, 2618b, 2618c, 2618d, to be tightly held and secured against the stent. This can help to prevent the wire wrap from interfering with the needle during sewing of the cuff. Additionally, this can be helpful during valve in valve replacement. In one example, once the valve has deteriorated, a balloon can be placed inside the valve and expanded to crack the frame <NUM> for a valve in valve procedure, as disclosed herein. The suture <NUM> connecting the first and second looped ends 2676a, 2676b of C-wrap <NUM> can break upon balloon expansion, thereby allowing the frame <NUM> to break and the annulus wire C-wrap <NUM> and the frame <NUM> to expand.

To create the C-wrap, a single radiopaque wire can be wrapped any number of times to form a closed loop that is in any desired pattern or shape. In one example, radiopaque wire <NUM> is wrapped around a mandrel or other device(s) (not shown) to form a closed loop <NUM> that is in the form of an elongated rectangle, as shown in <FIG>. The closed loop <NUM> is formed by wrapping the radiopaque wire <NUM> around the mandrel two times to form a first wire loop <NUM> and a second wire loop <NUM>. A transition region T10 is further shown where the wire <NUM> transitions between the first wire loop <NUM> and the second wire loop <NUM>. In other examples, any shape of loop may be formed, such as circular or triangular. The leading first end <NUM> of the radiopaque wire <NUM> and the second end <NUM> of the radiopaque wire <NUM> can be twisted together, as in previous examples, to ensure that the ends of the radiopaque wire <NUM> are secure. The closed loop <NUM> can then be removed from the mandrel and then be wrapped around the annular base <NUM> of frame <NUM> to form a "C" shape around the annular base that includes four wire wraps 2618a, 2618b, 2618c, 2618d and first end 2676a and second end 2676b. As shown, because the "C" wrap <NUM> is sized to extend around most, but not all, of the annular base <NUM>, the first and second looped ends 2676a, 2676b do not meet one another. Sutures <NUM> can be threaded through the first end 2676a and second end 2676b of the elongated shape, as shown in <FIG>, to secure the C-wrap <NUM> to the frame <NUM>. In other examples, the C-wrap frame is secured by three sutures, but multiple closed loops can be created. For example, four individual loops can be separately formed and stacked on top of one another. The four loops can be positioned around a portion of the base to form the C-wrap so that the first and second looped ends 2676a, 2676b of each loop do not extend all the way around the annular base and are spaced apart from one another. The first and second looped ends 2676a, 2676b of each loop may be secured to one another by sutures, thereby further securing the first, second third and fourth wire wraps 2618a, 2618b, 2618c, 2618d to the annular base <NUM> of the frame.

It is to be appreciated that any one of the aforementioned embodiments disclosing radiopaque elements on the commissure posts of a frame in <FIG> may be combined with any one of the embodiments disclosing a frame with radiopaque elements on the base of frame in <FIG>. This allows for radiopaque elements to be present on both the commissure posts and base of a frame, which in turn, provides for maximum visibility of the position of a surgical valve on an x-ray or fluoroscope. With this understanding, a few example combinations are described herein.

In one example, with reference to <FIG>, a one-third section of frame <NUM> is shown with radiopaque elements on both the commissure post <NUM> and base <NUM> of the frame. Apertures 3150a-<NUM> extend along base <NUM> between inflow edge <NUM> and base openings 3116a-3116d. Additional apertures 3132a-3132i are also positioned around central slot <NUM> in commissure post <NUM>. Wire <NUM> may be weaved into and out of each of the apertures, as in the previously described examples of <FIG>, <FIG> and <FIG>.

A single wire may be weaved through each of the apertures on both commissure post <NUM> and base <NUM>. Wire <NUM> may continuously extend through apertures 3150a-3150f on base <NUM>, and then from aperture 3150f upwards to aperture 3132i on commissure post <NUM>. Wire <NUM> may continue to weave into and out of apertures 3132a-<NUM> around commissure post <NUM>, and may then transition from aperture <NUM> on the commissure post to aperture <NUM> on base <NUM>. Wire <NUM> may then weave through the remaining apertures <NUM> - <NUM> on the base. The same wire apertures may be present on the remainder (not shown) of frame <NUM>, through which wire <NUM> may extend. Alternatively, more than one wire may be used on frame <NUM>. For example, a first wire may be used in the apertures on base <NUM>, and a second wire may be used in the apertures on commissure post <NUM>. Multiple wires may also be woven in tandem through the same apertures, or individually through different apertures.

With reference to <FIG>, a one-third section of frame <NUM> is shown with radiopaque elements on both the commissure post <NUM> and base <NUM> of the frame. This example incorporates the examples of <FIG> and <FIG>, as described above, and the prior descriptions are equally applicable here. As shown, a first radiopaque wire <NUM>-l extends around the tip <NUM> of commissure post <NUM> and through commissure post slot <NUM>. Wire <NUM>-l is wrapped four times through commissure post slot <NUM>, such that there are four rays 3222a, 3222b, 3222c, and 3222d of wire 3218a-l on commissure post <NUM>. A second wire <NUM>-<NUM> is wrapped around the circumference of the base <NUM> of frame <NUM>, as previously described herein. Wire <NUM>-<NUM> includes a first wrap 3218a, a second wrap 3218b, a third wrap 3218c, and a fourth wrap 3218d, but any number of wraps may be utilized, including two or more wraps.

The first end <NUM> and the second end <NUM> of wire <NUM>-<NUM> may be intertwined with one another to secure the wire to frame <NUM>, such as in any one of the configurations shown in <FIG>, or any configuration that would help to secure wire <NUM>-<NUM> to the frame. Alternatively, as shown in <FIG>, wire <NUM>-<NUM> around the base <NUM> of an alternative frame <NUM> may be wrapped so that first free end <NUM> and second free end <NUM> of the wire are spaced apart from one another and not secured together. As discussed in more detail with regard to corresponding <FIG>, the first free end <NUM> and the second free end <NUM> of wire <NUM>-<NUM> allow for expansion of frame <NUM> when it is desired to crack the frame. Frame <NUM> also includes first through fourth wire wraps 3322a-3322d of wire <NUM>-<NUM> around the tip <NUM> of commissure post <NUM>.

Another alternative combination in which radiopaque elements are positioned on both the commissure post and base of a frame is shown in <FIG>. Frame <NUM> illustrates first through fourth wire wraps 3422a-3422d of wire <NUM>-l extending around the tip <NUM> of commissure post <NUM>, such as previously described. Additionally, wire <NUM>-<NUM> positioned between the inflow edge <NUM> of frame <NUM> and base openings 3416a-3416d extends around base <NUM> in a flattened helical or looped pattern. As shown, there are ten circular loops H1-H10 extending across the one-third portion of the illustrated base <NUM>. The first end <NUM> and second end <NUM> of wire <NUM>-<NUM> at base <NUM> are shown as free ends, but in other examples may be secured together, as discussed below with regard to <FIG>. In other examples, the loops may take on any shape, such as square and triangular. Similarly, instead of loops, excess lengths of wire may be wrapped around the frame <NUM> in any other shape or form so as to allow for expansion of the wire when frame <NUM> is expanded.

Another alternative combination in which radiopaque elements are positioned on both the commissure post and base of a frame is shown in <FIG>. Frame <NUM>' is identical to frame <NUM> in <FIG>, except that the first free end <NUM>' and second free end <NUM>' of wire <NUM>-<NUM>' are secured together. Frame <NUM>' similarly illustrates first through fourth wire wraps 3422a'-3422d' of wire <NUM>-l' extending around the tip <NUM>' of commissure post <NUM>', such as previously described. Additionally, wire <NUM>-<NUM>' positioned between the inflow edge <NUM>' of frame <NUM>' and base openings 3416a'-3416d' extends around base <NUM>' in a flattened helical or looped pattern. As shown, there are ten circular loops H1'-H10' extending across the one-third portion of the illustrated base <NUM>'. The first end <NUM>' and second end <NUM>' of wire <NUM>-<NUM>' at base <NUM>' are intertwined together. In other examples, the loops may take on any shape, such as square and triangular. Similarly, instead of loops, excess lengths of wire may be wrapped around the frame <NUM> in any other shape or form so as to allow for expansion of the wire when frame <NUM>' is expanded.

Another alternative combination in which radiopaque elements are positioned on both the commissure post <NUM> and the base <NUM> of a frame is illustrated in <FIG>, a one-third section of frame <NUM>. As shown, a first radiopaque wire <NUM>-l extends around the tip <NUM> of commissure post <NUM> and through commissure post slot <NUM>. As in the prior examples, first radiopaque wire <NUM>-<NUM> is wrapped four times through commissure post slot <NUM> and around the tip <NUM>, such that there are four rays 3522a, 3522b, 3522c, and 3522d of wire <NUM>-<NUM> on commissure post <NUM>, but any number of wraps may be provided. A second wire <NUM>-<NUM> can optionally or additionally be provided at the base <NUM> of frame <NUM> in the form of a C-wrap <NUM>.

The C-wrap <NUM> extends around a portion of the circumference of base <NUM> between the inflow edge <NUM> of frame <NUM> and base openings 3516a-3516d. As shown, in this example, the C-wrap includes a first wrap 3518a, a second wrap 3518b, a third wrap 3518c, and a fourth wrap 3518d that extend around the base <NUM>. The first end 3576a and the second end 3676b of the C-wrap <NUM> are joined together by a suture <NUM>. For example, the suture <NUM> can be wrapped through the first and second looped ends 3576a, 3576b several times to secure the C-wrap <NUM> against the frame <NUM>. In this example, the sutures are shown being wrapped four times through the first and second ends 3576a, 3576b, but in other examples, the suture may alternatively be wrapped through the ends one time, two times, three times, or more than four times.

As previously described, prior to a TAVR procedure, the surgeon must understand the size of the structurally deteriorated surgical valve to determine the appropriate transcatheter valve to implant. According to aspects of the disclosure, one way for a surgeon to better understand the size of the surgical valve is to have a radiopaque indicator on the frame of the surgical valve itself to indicate the size of the frame. This may allow a surgeon to confirm the frame size indicated in the patient's medical records, or readily identify the size of the frame when no medical or other records of the frame size exist. The manufacturer of the surgical valve frame may create any system in which a radiopaque symbol, character or the like on the frame correlates to the frame size.

One example of such a radiopaque system is the use of a pre-set number of radiopaque indicators, such as beads, knots, or other indicators, that correlate to a particular frame size. For example, a frame with one radiopaque indicator may indicate a <NUM> frame and a frame with two radiopaque indicators may indicate a <NUM> frame. This progression may continue up through the highest valve size available.

<FIG> illustrates an example frame <NUM> with radiopaque indicators identifying the frame size. Frame <NUM> is otherwise similar to the example of <FIG>, except for the presence of radiopaque knots on one or more of the annular wire wraps. As in the example of <FIG>, frame <NUM> includes four wraps 4118a-4118d of wire <NUM> extending along the base <NUM> and adjacent the inflow edge <NUM> of frame <NUM>. Seven knots K1, K2, K3, K4, K5, K6 and K7 are provided on the fourth wrap 4118d of wire <NUM>, but may be provided on any one of the four wraps 4118a-4118d. Knots K1-K7 act as radiopaque indicators of the size of frame <NUM>.

Knots K1-K7 are shown evenly spaced apart from one another along the fourth wrap 4118d of wire <NUM>, but in other examples, the spacing of the knots may vary widely. For example, the knots may be spaced closer to one another, such that they are closely adjacent one another on one side of base <NUM>, or the spacing between individual knots may vary.

The knots may be tied directly into the length of wire <NUM>. As the fourth wire wrap 4118d is wrapped around base <NUM>, each knot may be tied directly into the wire. Alternatively, a predetermined length of wire may be prepared ahead of time with the appropriate number and spacing of knots. Still further, knots K1-K7 may be formed from separate wires individually tied in knots to wire <NUM>. Any style of knot may be utilized on wire <NUM>. Several known knots, for example, are shown in <FIG> and include, without limitation, double <NUM>-ply knot <NUM>, single <NUM>-ply knot <NUM>, overhand knot <NUM>, Steve Dore knot <NUM>, <FIG> knot <NUM> and double overhand knot <NUM>.

In another example system, instead of tying knots onto the annular wire, any number of external radiopaque elements may be secured to the wire. <FIG> illustrates a one-third section of an alternative frame <NUM> in which seven radiopaque beads B1-B7 are attached to wire <NUM>. In this example, instead of using knots, radiopaque beads on wire <NUM> may be used to represent a pre-set valve size. It is to be appreciated that any other type of radiopaque feature may be attached to the annular wire or frame itself to indicate frame size.

Each of the beads B1-B7 may have a central bore or lumen (not shown) through which wire <NUM> may pass. As the fourth wrap 4218d is wrapped around base <NUM>, each radiopaque bead B1-B7 may be deposited onto the wire. Alternatively, fourth wrap 4218d may be a separate and individual wire wrap with beads thereon. In this example, the beads are loose and capable of moving relative to one another. In other examples, each of beads B1-B7 may be secured in place such as by tying a knot at each end of the bead, or by looping the wire through the bead twice so as to capture the bead by the wire. Alternatively, an adhesive may be used to secure the bead in place, an alternative bead that snaps onto the wire and remains secured in place may be used, or other known arrangements may be used to secure the beads in place on the wire.

The beads may have any shape or size, provided they are at least partially comprised of or coated with a radiopaque material, including those radiopaque materials describe above. For example, referring to <FIG>, bead B1 has a large rectangular shape; bead B2 has an oval pill-shape; bead B3 has a smaller rectangular shape; bead B4 has a square shape; and bead B5 has an elongated and thin rectangular shape.

In another example system, the diameter of the wire may be changed along its length so that the differing diameters may act as a radiopaque indicator. <FIG> illustrates a one-third section of a frame <NUM>. A single wire <NUM> is shown extending along base <NUM> of frame <NUM> at a position spaced from inflow edge <NUM>. Wire <NUM> has a first diameter D1 and a second diameter D2 that alternate with one another along the length of the wire. Diameter D1 is greater than diameter D2 so as to enable diameter D1 to act as a radiopaque indicator. The number of times the greater diameter D1 appears along the length of the wire may correspond to a surgical valve having a predetermined size. For example, diameter D1 is shown seven times along the illustrated section of frame <NUM>, which may indicate a specific frame size as dictated by the valve manufacturer.

The enlarged wire diameter D1 may be formed in a variety of ways. In one example, diameter D1 may be formed during the extrusion of the radiopaque wire and may be extruded to have a different diameter than diameter D2. In another example, wire <NUM> may be stamped so that a length of the wire has different diameters. Alternatively, diameter D1 may be formed by compressing or pinching along the length of wire <NUM> after an initial wire having a uniform diameter D2 has been formed.

Instead of requiring a surgeon to count the number of individual radiopaque elements present on a frame, another system includes providing a radiopaque character directly on the frame to indicate frame size. For example, radiopaque wire or other radiopaque elements may be configured into the shape of any letter, number, or symbol that may be used to directly or indirectly identify the size of a frame. <FIG> illustrates an example in which radiopaque wire is configured on frame <NUM> into the shape of a specific number corresponding to the size of the frame. As shown, frame <NUM> is similar to frame <NUM> of <FIG>, which includes additional apertures along the frame. Wire <NUM> may extend through two apertures 4432c and 4432e on directly opposite sides of commissure post slot <NUM>. Wire <NUM> also extends diagonally from aperture 4432e to aperture 4432a. The completed wire creates the number "<NUM>". In other examples, any number or symbol may be provided on the frame that ultimately corresponds to the size of the frame, either directly or indirectly. In this example, providing additional apertures around the commissure post slot may provide other options for patterning wire into the shape of a number or other character.

It is to be appreciated that the radiopaque indicators described with regard to <FIG> may be implemented on any of the examples described herein, including appearing on either or both of the commissure post and base of the frame.

It is to be understood that the figures and descriptions of the present disclosure have been simplified to illustrate elements that are relevant for a clear understanding of the present disclosure, while eliminating, for purposes of clarity, many other elements which are conventional in this art. Those of ordinary skill in the art will recognize that other elements may be desirable for implementing the present disclosure.

Claim 1:
A prosthetic heart valve, comprising:
a non-collapsible annular frame (<NUM>) extending in a longitudinal direction between an inflow edge and an outflow edge, the frame having a plurality of annularly spaced commissure posts (1106a, 1106b, 1106c) adjacent the outflow edge, each of the commissure posts having a tip (1120a, 1120b, 1120c) and a post slot (1114a) spaced apart from the tip and extending along a length of the commissure post;
a radiopaque element (1118a') including an elongated main body having a first end (1124a') and a second end, the radiopaque element extending around the tip and through the post slot of at least one of the commissure posts so that a portion of the main body extends between the post slot and the tip; and
a valve assembly connected to the frame and including a plurality of leaflets,
wherein the first end (1124a') and the second end of the radiopaque element are intertwined (1129a') so as to secure the radiopaque element to the tip of the at least one of the commissure posts, and the intertwined first and second ends are positioned adjacent at least a portion of the main body that extends between the post slot and the tip, or the intertwined first and second ends are positioned within the post slot of the at least one of the commissure posts.