Bladder with indicia for rotational alignment

Abstract

A balloon for a delivery system of a transcatheter heart valve prosthesis includes indicia for rotationally orienting the balloon within a native valve. The balloon includes a plurality of indicia sized, shaped and positioned on the balloon such that the indicia indicate whether the balloon is in a desired rotational orientation when viewed in the tip overlapping view image. Methods for rotationally aligning a balloon of a transcatheter heart valve prosthesis delivery system within a native valve are also provided.

Description

Technical Field

[0001] The present invention relates generally to medical devices. More particularly, the present technology relates to delivery systems for heart valve prostheses, and in particular to delivery systems including radiopaque markers, and systems and methods for rotationally aligning such delivery systems. Background Art

[0002] Patients with various medical conditions or diseases may require surgical procedures to install implantable medical devices. For example, valve regurgitation or calcified stenosis of heart valve leaflets may be treated with heart valve replacement surgery. Traditional surgical valve replacement surgery requires a sternotomy and cardiopulmonary bypass, which can be extremely traumatic and uncomfortable for the patient. Traditional surgical valve surgery may also require a long recovery period and may result in life-threatening complications.

[0001] An alternative to traditional surgical valve replacement procedures is to use minimally invasive techniques to deliver implantable medical devices. For example, a transcatheter heart valve prosthesis can be delivered percutaneously and transluminally to an implantation site. In such a method, a transcatheter heart valve prosthesis can be compressed or crimped on a delivery catheter for insertion into the patient's vasculature; advanced to the implantation site; and re-expanded to be deployed at the implantation site.

[0002] In certain situations, such as but not limited to aortic transcatheter heart valve prostheses, it may be desirable to rotationally orient the transcatheter heart valve prosthesis. In a delivery system that radially constrains a transcatheter heart valve prosthesis, such as in a sheath or a sac, it may be beneficial to rotationally orient the transcatheter heart valve prosthesis before the transcatheter heart valve prosthesis is released from the sac. Therefore, there remains a general need in the art for improved devices and methods for monitoring and tracking the positioning and deployment of implantable medical devices during guidance through or within the anatomy of a patient and the positioning at an implantation site. Summary of the invention

[0003] Embodiments of the present invention are directed to delivery systems including balloons having markings configured to enable a clinician to determine whether the balloon is in a desired rotational orientation, and methods for rotationally aligning such balloons.

[0004] In a first example, a delivery system includes a balloon disposed at a distal end of the delivery system and configured to radially constrain a heart valve prosthesis in a radially compressed configuration for delivery to a treatment site. A plurality of markers are disposed on the balloon, wherein the plurality of markers are sized, shaped, and positioned on the balloon such that when viewed in a cusp overlap view image, the markers indicate whether the balloon is in a desired rotational orientation.

[0005] In a second example, in the delivery system of the first example, the desired rotational orientation defines an aligned position or a position within an allowed rotational angle of the aligned position.

[0006] In a third example, in the delivery system of the first example or the second example, the plurality of markings includes a first marking and a second marking, wherein the first marking and the second marking are spaced 180 degrees apart around a circumference of the balloon.

[0007] In a fourth example, in the delivery system of the third example, the first marking has a first width and the second marking has a second width, wherein the first width is greater than the second width.

[0008] In a fifth example, in the delivery system of the fourth example, when the second mark is between the right and left edges of the first mark in the cusp overlap view image, the balloon is in the aligned position or in a position within an allowable rotation angle of the aligned position.

[0009] In a sixth example, in the delivery system of any one of the third to fifth examples, the first marker and the second marker are longitudinally offset from each other such that one of the first marker and the second marker is closer to the distal end of the balloon than the other of the first marker and the second marker.

[0010] In a seventh example, in the delivery system of one of the fourth to sixth examples, the second width is the allowed rotation angle in radians multiplied by the balloon radius plus the first width.

[0011] In an eighth example, in the delivery system of the first example or the second example, the plurality of markers include a first marker, a second marker, and a third marker spaced 120 degrees apart around the circumference of the sac, wherein the first marker, the second marker, and the third marker are configured to align with the commissures of a transcatheter heart valve prosthesis configured to be received in the sac.

[0012] In a ninth example, in the delivery system of the eighth example, when the first marker and the second marker overlap or are aligned side by side with no gap therebetween in the cusp overlap perspective image, and the third marker is toward the right side of the capsule in the cusp overlap perspective image, the capsule is in the aligned position or in a position within the allowable rotation angle of the aligned position.

[0013] In a tenth example, in the delivery system of the ninth example, the first marker and the second marker each have a width approximately equal to the allowed rotation angle in radians multiplied by the radius of the balloon and divided by two.

[0014] In an eleventh example, a method for rotationally aligning a balloon of a delivery system containing a transcatheter heart valve prosthesis within a native heart valve includes: percutaneously delivering the balloon containing the transcatheter heart valve prosthesis to the native heart valve, wherein the balloon includes a plurality of markers; obtaining a cusp overlap perspective image of the balloon within the native heart valve; determining whether the balloon is in a desired rotational orientation based on the cusp overlap perspective image and the plurality of markers; and if the cusp overlap perspective image indicates that the balloon is not in the desired rotational orientation, rotating the balloon until the balloon is in the desired rotational orientation.

[0015] In a twelfth example, in the method of the eleventh example, the desired rotational orientation includes an aligned position or a position within an allowed rotation angle of the aligned position.

[0016] In a thirteenth example, in the method of the eleventh example or the twelfth example, the plurality of marks include a first mark and a second mark, wherein the first mark and the second mark are spaced 180 degrees apart around the circumference of the sac, and the commissure of the transcatheter heart valve prosthesis is spaced 90 degrees apart from each of the first mark and the second mark.

[0017] In a fourteenth example, in the method of the thirteenth example, the first mark has a first width and the second mark has a second width, wherein the first width is greater than the second width.

[0018] In a fifteenth example, in the method of the fourteenth example, determining whether the capsule is in the desired rotational orientation includes determining whether the second marker is between right and left edges of the first marker based on the cusp overlap perspective image.

[0019] In a sixteenth example, in the method of any one of the thirteenth to fifteenth examples, the first marker and the second marker are longitudinally offset from each other such that one of the first marker and the second marker is closer to the distal end of the balloon than the other of the first marker and the second marker.

[0020] In a seventeenth example, in the method of any one of the fourteenth to sixteenth examples, the second width is an allowed rotation angle in radians multiplied by a capsule radius plus the first width.

[0021] In an eighteenth example, in the method of the eleventh example or the twelfth example, the plurality of markers include a first marker, a second marker, and a third marker spaced 120 degrees apart around the circumference of the sac, and wherein each of the first marker, the second marker, and the third marker is rotationally aligned with a corresponding commissure of the transcatheter heart valve prosthesis.

[0022] In a nineteenth example, in the method of the eighteenth example, determining whether the capsule is in the desired rotational orientation includes determining whether the first marker and the second marker overlap or are aligned side by side with no gap therebetween based on the cusp overlap perspective image, and whether the third marker is toward the right side of the capsule.

[0023] In a twentieth example, in the method of the eighteenth example or the nineteenth example, the first mark and the second mark each have a width approximately equal to the allowed rotation angle in radians multiplied by the radius of the capsule and divided by two.

[0024] The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the following description. Other features, objects, and advantages of the techniques described in the disclosure will become apparent from the description and drawings, and from the claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] The foregoing and other features and advantages of the present disclosure will become apparent from the following description of the embodiments of the present invention as shown in the accompanying drawings. The accompanying drawings, which are incorporated herein and form a part of the specification, are further used to explain the principles of the present disclosure and enable those skilled in the relevant art to make and use the embodiments of the present disclosure. The accompanying drawings may not be drawn to scale.

[0026] Figure 1A to Figure 1B Depicted is a representation of an exemplary delivery system for a transcatheter heart valve prosthesis.

[0027] FIG. 2A to FIG. 2C Depicted is a representation of an exemplary transcatheter heart valve prosthesis that may be used with the delivery systems described herein.

[0028] Figure 3 Demonstration of the native aortic valve as seen from the aorta is depicted and different viewing angles of the imaging system are depicted.

[0029] FIG. 4A to FIG. 4B Depicted is a representation of a capsule of a delivery system according to embodiments herein, the capsule comprising imaging markers.

[0030] Figure 5A Depicted is a diagram according to an embodiment of the present invention viewed from the aorta and including Figure 4A Demonstration of the native aortic valve with the balloon, showing the aligned position.

[0031] Figure 5B Depicted is a schematic representation of a fluoroscopic image of a native aortic valve using a cusp overlay view and showing Figure 4A A mark of the sac where the sac is in the aligned position.

[0032] Fig. 6A Depicted is a diagram according to an embodiment of the present invention viewed from the aorta and including Figure 4ADemonstration of a balloon-mounted native aortic valve showing the balloon rotated 20° clockwise from the aligned position.

[0033] Figure 6B Depicted is a schematic representation of a fluoroscopic image of a native aortic valve using a cusp overlay view and showing Figure 4A The capsule is marked Fig. 6A Alignment position shown.

[0034] Fig. 7A Depicted is a diagram according to an embodiment of the present invention viewed from the aorta and including Figure 4A Demonstration of a balloon-mounted native aortic valve showing the balloon rotated 20° counterclockwise from the aligned position.

[0035] Figure 7B Depicted is a schematic representation of a fluoroscopic image of a native aortic valve using a cusp overlay view and showing Figure 4A The capsule is marked Fig. 7A Alignment position shown.

[0036] Fig. 8A Depicted is a diagram according to an embodiment of the present invention viewed from the aorta and including Figure 4A Demonstration of a balloon-mounted native aortic valve showing the balloon rotated 45° clockwise from the aligned position.

[0037] Figure 8B Depicted is a schematic representation of a fluoroscopic image of a native aortic valve using a cusp overlay view and showing Figure 4A The capsule is marked Fig. 8A Alignment position shown.

[0038] FIG. 9A to FIG. 9B Depicted is an illustration of a second embodiment of indicia on a capsule of a delivery system according to embodiments herein.

[0039] Fig. 10A Depicted is a diagram according to an embodiment of the present invention viewed from the aorta and including Fig. 9A Demonstration of the native aortic valve with the balloon, showing the aligned position.

[0040] Fig. 10B Depicted is a schematic representation of a fluoroscopic image of a native aortic valve using a cusp overlay view and showing Fig. 9A The capsule is marked Fig. 10A Alignment position shown.

[0041] Fig.11A Depicted is a diagram according to an embodiment of the present invention viewed from the aorta and including Fig. 9ADemonstration of a balloon-mounted native aortic valve showing the balloon rotated 20° clockwise from the aligned position.

[0042] Fig. 11B Depicted is a schematic representation of a fluoroscopic image of a native aortic valve using a cusp overlay view and showing Fig. 9A The capsule is marked Fig.11A Alignment position shown.

[0043] Fig. 12A Depicted is a diagram according to an embodiment of the present invention viewed from the aorta and including Fig. 9A Demonstration of a balloon-mounted native aortic valve showing the balloon rotated 20° counterclockwise from the aligned position.

[0044] Fig. 12B Depicted is a schematic representation of a fluoroscopic image of a native aortic valve using a cusp overlay view and showing Fig. 9A The capsule is marked Fig. 12A Alignment position shown.

[0045] Fig.13A Depicted is a diagram according to an embodiment of the present invention viewed from the aorta and including Fig. 9A Demonstration of a balloon-mounted native aortic valve showing the balloon rotated 60° clockwise from the aligned position.

[0046] Fig. 13B Depicted is a schematic representation of a fluoroscopic image of a native aortic valve using a cusp overlay view and showing Fig. 9A The capsule is marked Fig.13A Alignment position shown. DETAILED DESCRIPTION

[0047] It should be understood that the multiple different embodiments disclosed herein can be combined into combinations different from those specifically presented in the specification and the drawings. It should also be understood that, according to the examples, certain actions or events of any process or method described herein can be performed in different orders, can be added, merged or completely omitted (for example, all described actions or events may not be necessary for implementing these technologies). In addition, although for the sake of clarity, certain aspects of the present disclosure are described as being performed by a single device or component, it should be understood that the technology disclosed herein can be performed by a combination of devices or components associated with, for example, a delivery device. The following detailed description is merely exemplary in nature and is not intended to limit the invention of the present application and the use of the present invention. In addition, it is not intended to be bound by any express or implied theory presented in the aforementioned technical field, background technology, content of the invention or the following detailed description.

[0048] As used in this specification, the singular forms "a", "an", "the" also specifically encompass the plural forms of the terms to which they refer, unless the content clearly indicates otherwise. The term "about" as used herein means approximately, within a range, roughly, or around. When the term "about" is used in conjunction with a numerical range, it modifies this range by extending the boundaries above and below the listed values. In general, the term "about" as used herein modifies a numerical value to a variation of 5% above and below the stated value. It should be understood that the use of the term "about" also encompasses specifically listed numbers or values.

[0049] The terms "proximal" and "distal" as used herein with respect to delivery systems are used with reference to clinicians using these devices. Thus, "proximal" and "proximally" refer to a direction toward the clinician, while "distal" and "distally" refer to a direction away from the clinician. The terms "proximal" and "distal" as used herein with respect to a medical device to be implanted, such as a heart valve prosthesis, are used with reference to the direction of blood flow. Thus, "proximal" and "proximally" refer to an upstream direction, while "proximal" and "proximally" refer to a downstream direction.

[0050] As used herein, the terms "generally" and "substantially" mean approximately. When used to describe an angle, such as "substantially parallel" or "substantially perpendicular," the term "substantially" means within 10 degrees of the angle. When used to describe a shape, such as "substantially" or "generally" cylindrical, "substantially" or "generally" tubular, or "substantially" or "generally" conical, these terms mean that to a person of ordinary skill in the art observing the shape with the naked eye, the shape would appear to be cylindrical or tubular or conical, respectively.

[0051] Figure 1A to Figure 1B An exemplary delivery system 100 for a transcatheter heart valve prosthesis, such as transcatheter heart valve prosthesis 200 discussed in further detail below, is shown. In an embodiment, the transcatheter heart valve prosthesis is self-expanding. Delivery system 100 includes distal end 103 and proximal end 105.

[0052] In particular, the delivery system 100 includes a handle 102. The handle 102 enables a clinician to manipulate a distal end 103 of the delivery system 100 and includes an actuator for moving components of the delivery system 100 relative to other components. In the delivery system 100, an outer shaft 104 is coupled to an actuator of the handle 102, which is used to move the outer shaft 104 relative to an inner shaft 112. The distal portion of the outer shaft 104, referred to as a sac 150, is configured to surround a transcatheter heart valve prosthesis 200 during delivery to a treatment site (e.g., a native heart valve), and to be retracted from the transcatheter heart valve prosthesis 200 to expose the transcatheter heart valve prosthesis 200 so that it self-expands. The inner shaft 112 is coupled to the handle 102 so that movement of the handle is translated into movement of the inner shaft 112 and a distal tip 108 coupled to the distal end of the inner shaft 112. The inner shaft 112 and the distal tip 108 can also translate relative to the outer shaft 104 and the handle 102 via a tip retractor. In the illustrated embodiment, the intermediate member 114 is disposed between the inner shaft 112 and the outer shaft 104, and the intermediate member 114 includes a retainer or mandrel 110 attached to a distal portion thereof for receiving the paddles 250 of the transcatheter heart valve prosthesis 200, which is described in further detail below.

[0053] A flush port 116 is disposed on the handle 102. In the illustrated delivery system 100, when the transcatheter heart valve prosthesis 200 is properly loaded into the delivery system 100, there are certain relationships between the features of the transcatheter heart valve prosthesis 200 and the features of the delivery system 100, which can assist in predicting the proper rotational orientation of the transcatheter heart valve prosthesis 200 disposed within the capsule 150. In particular, when the transcatheter heart valve prosthesis 200 is loaded into the delivery system 100, the paddles 250 are placed into the paddle pockets (not shown) of the mandrel 110, spaced 180° apart from each other. As described in further detail below, the paddles 250 with C-shaped markings (sometimes referred to as "C-shaped tabs" or "C-shaped paddles") are aligned with one of the commissures 209 of the transcatheter heart valve prosthesis 200. Further, when transcatheter heart valve prosthesis 200 is loaded into delivery system 100 , C-shaped paddle 250 is positioned in a paddle pocket that is aligned with flush port 116 on handle 102 of delivery system 100 .

[0054] As stated above, this is a brief description of an exemplary delivery system 100 . Figure 1A to Figure 1B The other parts shown are not described in detail here and are clear to those skilled in the art.

[0055] FIG. 2A to FIG. 2C An example of a transcatheter heart valve prosthesis 200 is shown. Although details of heart valve prosthesis 200 are described herein, these details are not intended to be limiting, and the systems and methods described herein may be used with any transcatheter heart valve prosthesis. Figure 2A is a side view of transcatheter heart valve prosthesis 200 in a normal or expanded (uncompressed) configuration. Figure 2B Transcatheter heart valve prosthesis 200 is shown in a compressed configuration (e.g., when compressively retained within a delivery system, such as within a distal portion of a delivery system, as known to those skilled in the art). Transcatheter heart valve prosthesis 200 includes a stent or frame 202 (hereinafter "stent") and a valve structure 204. Stent 202 can take any of the forms described herein and variations thereof, and is generally configured to be movable from a compressed configuration ( Figure 2B ) expands to an uncompressed, normal, or expanded configuration ( Figure 2A In some embodiments, the stent 202 is self-expanding. The valve structure 204 is assembled to the stent 202 and provides two or more (typically three) leaflets 206, as described below with reference to Figure 2C Further details are shown.

[0056] In embodiments, the valve structure 204 can be assembled to the stent 202 in various ways, such as by suturing the valve structure 204 to one or more struts 208 or commissure posts defined by the stent 202 using sutures 210. The valve structure 204 is capable of blocking flow in one direction to regulate flow through the valve leaflets 206, which can form a replacement mitral valve or tricuspid valve. The valve leaflets 206 can be attached to an inner skirt or graft material 207 that surrounds or lines a portion of the stent 202, as known to those of ordinary skill in the art of prosthetic tissue valve construction. The valve leaflets 206 can be sutured or otherwise fixed and sealingly attached to the inner surface of the inner skirt 207 along their base with sutures 210. The transcatheter heart valve prosthesis 200 also includes an outer skirt (not shown) that is coupled to the outer surface of the stent at the inflow end 212 of the stent 202. The outer skirt can be attached to the stent 202 by any suitable means known to those skilled in the art, such as, but not limited to, suturing / stitching, welding, adhesives, or other mechanical couplings. Adjacent pairs of leaflets are attached to each other at their lateral ends to form commissures 209, wherein the free edges of the leaflets form abutment edges that meet in the abutment region. In the illustrated embodiment, the commissures 209 are configured to span between the leaflets of the stent 202 so that forces are evenly distributed within the commissures and the stent 202, however, this is not intended to be limiting.

[0057] FIG. 2A to FIG. 2C The transcatheter heart valve prosthesis 200 can be configured to replace or repair an aortic valve. Alternatively, other shapes suitable for the specific anatomical structure of the valve to be repaired are also contemplated (for example, the shape and / or size of the stented prosthetic heart valve according to the present disclosure can be designed to replace the native mitral valve, pulmonary valve or tricuspid valve). Figure 2AIn the example of the embodiment of the present invention, the valve structure 204 extends less than the entire length of the stent 202, but in other embodiments, it can extend along the entire length or nearly the entire length of the stent 202. A variety of other configurations are also acceptable and within the scope of the present disclosure. For example, the stent 202 can have a more cylindrical shape when it is in a normal expanded arrangement.

[0058] Stent 202 includes struts 208 that serve as a support structure arranged relative to one another to provide desired compressibility and strength to transcatheter heart valve prosthesis 200. For example, Figure 2A As best shown, the struts 208 are arranged in a manner to form windows or inter-cells 219 around the circumference of the stent 202 and along the length of the stent. The struts 208 and crowns 220 of longitudinally adjacent rows are connected together at the crowns 220 to form nodes 216. The arrangement of the struts 208 and crowns 220 to form multiple rows of inter-cells 219 forms a central lumen or channel and forms an inflow end 212 and an outflow end 214. As shown, in an embodiment, the overall structure formed by the struts 208 and crowns 220 can form a stent 202 having a generally hourglass shape, wherein the diameter of the inflow end 212 and the outflow end 214 is greater than the diameter of the middle portion of the stent 202. However, this shape is not intended to be limiting, and other shapes, such as a more cylindrical shape, can be utilized. The stent 202 can be formed by a laser cutting manufacturing method and / or another conventional stent forming method that a person of ordinary skill in the art will understand. The lateral cross-section of the stent 202 may be trapezoidal, circular, elliptical, rectangular, hexagonal, square or other polygonal, but it is currently believed that trapezoidal, circular or elliptical may be preferred when used to replace an aortic valve.

[0059] In an embodiment, Figure 2A As shown, the stent 202 may also include one or more paddles 250 that removably couple the prosthetic heart valve 200 to a delivery system, such as the delivery system 100. For example, but not limitation, the EnVeo TM PRO catheter or EnVeo TM R catheter is a known delivery system. Although Figure 2A and Figure 2CTwo (2) paddles 250 are shown, but those skilled in the art will recognize that paddles 250 may be replaced with other components (e.g., eyelets, rings, grooves, or any other suitable coupling members), and that more or fewer paddles or other coupling members may be utilized. In the illustrated embodiment, at least one of paddles 250 is radiopaque so as to be visible under fluoroscopy, wherein, in this embodiment, the radiopaque paddles include C-shaped markings to assist in orienting transcatheter heart valve prosthesis 200 during implantation. Those skilled in the art will recognize that other asymmetric shapes may be utilized to assist in determining the orientation of transcatheter heart valve prosthesis 200 during implantation. In embodiments (e.g., FIG. 2A to FIG. 2C In the embodiment of the present invention, the paddle 250 with the C-shaped marking is axially aligned with one of the commissures 209 of the valve structure 204, such as Figure 2A Best seen in.

[0060] Reference now Figure 3 , shows a schematic diagram of an exemplary native aortic valve as seen from the aorta. As can be seen, the native aortic valve includes three leaflets or cusps: the right coronary cusp RCC, the left coronary cusp LCC, and the non-coronary cusp NCC. As known to those skilled in the art, the right coronary artery includes an ostium or opening RCO in the sinus of Valsalva, which is higher than the right coronary cusp RCC and lower than the sinotubular junction (not shown). Similarly, the left coronary artery includes an ostium or opening LCO in the sinus of Valsalva, which is higher than the left coronary cusp RCC and lower than the sinotubular junction (not shown). Further, the non-coronary cusp NCC is in a sinus that does not include an ostium or opening of a coronary artery.

[0061] As is known to those skilled in the art and Figure 3 Thus, the right noncoronary commissure 120A is where the right coronary valve cusp RCC joins the noncoronary valve cusp NCC, the left-right commissure 120B is where the left coronary valve cusp LCC joins the right coronary valve cusp RCC, and the left noncoronary commissure 120C is where the left coronary valve cusp LCC joins the noncoronary valve cusp NCC. Figure 3 An idealized native aortic valve is shown in which the left coronary artery ostium LCO and the right coronary artery ostium are spaced 120 degrees apart. However, as is known to those skilled in the art, there may be patient-specific variations of 10-20 degrees in the location of the commissures. Further, it is worth noting that the commissures are not exactly 120 degrees apart. Rather, on average, the left-right commissure LRC is closer to the left non-coronary commissure LNC than to the other two commissures, i.e., approximately 108 degrees. Further, the location of the ostiums of the left and right coronary arteries may vary by approximately 15-20 degrees depending on the patient's anatomy. In Figure 3 In , a clock face has been added and centered within the exemplary native aortic heart valve and is used herein to help reference various locations within the native aorta. For example, Figure 3 The right coronary artery ostium RCO is shown at the 1 o'clock position and the left coronary artery ostium LCO is shown at the 5 o'clock position with respect to the clock face. Similarly, the autologous commissures 120A, 120B and 120C are shown at the 11 o'clock, 3 o'clock and 7 o'clock positions, respectively.

[0062] With this understanding, imaging systems used during transcatheter heart valve replacement procedures (such as fluoroscopic imaging systems) typically include a C-arm gantry that enables different views of the native aortic valve. One particular view is the cusp overlap view COVA. In the cusp overlap view, e.g. Figure 3 As shown, the viewing angle of the imaging system is such that the right coronary valve cusp RCC and the left coronary valve cusp LCC overlap each other. In the cusp overlap view, the non-coronary valve cusp NCC is to the left of the left coronary valve cusp LCC and the right coronary valve cusp RCC. Further, in the cusp overlap view, the right non-coronary commissure 120A and the left non-coronary commissure 120C are aligned with each other, that is, they overlap. In the cusp overlap view, the left-right commissure 120B is located to the right of the right non-coronary commissure 120A and the left non-coronary commissure 120C. Figure 3 The COVA view of the cusp overlap is shown by arrows.

[0063] Figure 3 Also shown is the position of the C-shaped paddle 250 of the transcatheter heart valve prosthesis 200. As described above, the C-shaped paddle 250 is axially aligned with the commissure 209 of the valve structure 204. It is desirable that the commissure 209 of the valve structure 204 of the transcatheter heart valve prosthesis 200 is aligned with the native commissures 120A, 120B, 120C of the native aortic valve. Figure 3 In the idealized native aortic valve shown, the native commissures are 120 degrees apart from each other. As described above with respect to the transcatheter heart valve prosthesis, the commissures 209 of the valve structure 204 are 120 degrees apart from each other. Therefore, the commissures 209 can be aligned with the native commissures 120. Aligning the prosthetic commissures with the native commissures provides many benefits, including but not limited to not blocking the coronary artery ostia RCO, LCO. Those skilled in the art will recognize that in practice, the autologous anatomical structure is usually not the idealized anatomical structure described herein. However, the principles described herein can be used and adapted to the patient's specific anatomical structure, such as determined by a preoperative CT scan.

[0064] refer to Figure 3, the C-shaped paddle 250, and therefore one of the commissures 209 of the valve structure 204, is aligned with the right-left commissure 120B. In an embodiment, it is preferred that the commissure 209 of the valve structure 204 is within 20 degrees of the right-left commissure 120B. This is Figure 3 200 is shown as being within a zone of 40°-60° (40-60 degrees) from the right coronary ostium RCO and within a zone of 40°-60° (40-60 degrees) from the left coronary ostium LCO. Thus, this provides a 40 degree rotational range for the transcatheter heart valve prosthesis 200 to be oriented relative to the native valve and still be considered acceptable. Those skilled in the art will recognize that the ranges noted above are not intended to be limiting, and that the systems and techniques described below may be modified and used with other ranges (smaller or larger) that may be considered acceptable.

[0065] Having generally described delivery system 100 and transcatheter heart valve prosthesis 200 , specific embodiments of balloon 150 with imaging markers, and methods and systems for rotationally orienting transcatheter heart valve prosthesis 200 using balloon 150 with imaging markers will be described.

[0066] FIG. 4A to FIG. 4B An embodiment of an imaging marker disposed on the capsule 150 of the delivery system 100 is shown. Figure 4A A close-up view of the sac 150 of the delivery system 100 is shown. As can be seen, the sac 150 of the delivery system 100 is a tubular structure including a distal end 151 and a proximal end 152. The inner surface of the sac 150 defines a central lumen 153 that extends parallel to the central longitudinal axis CLA of the delivery system 100 and extends the entire longitudinal length of the sac 150, i.e., from the distal end 151 to the proximal end 152. In an embodiment, the sac 150 has a radius R of approximately 2.5-3.0 mm. However, this is not intended to be limiting, and the sac 150 can have a radius (and diameter) required to radially constrain a given transcatheter heart valve prosthesis. Therefore, for a transcatheter heart valve prosthesis having a larger diameter when radially compressed, the sac can have a larger diameter, and for a transcatheter heart valve prosthesis having a smaller diameter when radially compressed, the sac can have a smaller diameter. During delivery to the treatment site, balloon 150 disposed at distal end 103 of delivery system 100 constrains transcatheter heart valve prosthesis 200 into a radially compressed configuration, such as Figure 2B When the delivery system 100 is deployed at the treatment site (in this example, the native aortic valve), the balloon 150 is moved proximally (at Figure 4A The inlet end 212 of the transcatheter heart valve prosthesis 200 is first exposed in the illustrated embodiment.

[0067] like Figure 4A As shown, the capsule 150 includes an imaging marker 160 disposed on the capsule 150. More specifically, the imaging marker 160 can be attached to, positioned in, and / or formed in the capsule 150 using any type of process and / or procedure. Further, for example and without limitation, the marker 160 can be press-fit, plated, printed on the capsule 150, or otherwise attached or added to the capsule. In any embodiment, the imaging marker 160 can include a radiopaque material or other material that allows the marker 160 to be detected and / or observed under radiography during the implantation of the transcatheter heart valve prosthesis 200 via the delivery system 100. Examples of radiopaque materials include metals such as platinum-iridium, gold, iridium, palladium, rhodium, titanium, tantalum, tungsten, and alloys thereof. Other examples of radiopaque materials include polymeric materials such as nylon, polyurethane, silicone, PEBAX, PET, polyethylene, which have been mixed or compounded with compounds of barium, bismuth, and / or zirconium (e.g., barium sulfate, zirconium oxide, bismuth subcarbonate, etc.). In an embodiment, gold is a preferred marker material due to its visibility.Further, in addition to the radiopaque materials noted above, the imaging marker 160 can be a feature on the capsule 150 of the delivery system 100 that can be seen under fluoroscopy as distinct from other features of the delivery system 100 .

[0068] exist FIG. 4A to FIG. 4B In the embodiment of FIG. 1 , the capsule 150 includes two markings 160A, 160B. Figure 4A As shown, the marks 160A and 160B are arranged 180 degrees apart from each other. Figure 4A In the embodiment of FIG. 1 , when viewing the bladder 150 from the front, the marking 160B is on the “front” of the bladder 150 and the marking 160A is on the “back” of the bladder 150. Those skilled in the art will recognize that only reference to Figure 4A "Front" and "back" are used to refer to the relative positions of the indicia 160A, 160B and are not intended to be limiting.

[0069] Further, in FIG. 4A to FIG. 4B In the embodiment of the present invention, the markings 160A, 160B are longitudinally offset from each other. In other words, one marking is distal to the other marking. FIG. 4A to FIG. 4BIn the illustrated embodiment, marker 160B is distal to marker 160A. In other words, marker 160B is closer to distal end 151 of capsule 150 than marker 160A. Thus, in the illustrated embodiment, marker 160A is disposed proximal to marker 160B, and marker 160B is disposed distal to marker 160A. However, this is not intended to be limiting, and any of these markers may be a distal marker and / or a proximal marker. In the illustrated embodiment, markers 160A, 160B are longitudinally offset so that they do not obscure each other when viewed in a fluoroscopic image, as described in more detail below.

[0070] Figure 4B A close-up view of markers 160A and 160B is shown. FIG. 4A to FIG. 4B In an embodiment, each of markers 160A and 160B is rectangular in shape. However, this is not intended to be limiting, and other shapes may be used. The size of markers 160A and 160B is designed so that when viewed in a cusp overlap perspective in a fluoroscopic image, the position of marker 160A relative to marker 160B enables the clinician to determine whether transcatheter heart valve prosthesis 200 is rotationally oriented to avoid obstruction of the ostium of the coronary artery, as described in more detail below. Therefore, the size of markers 160A, 160B relative to each other is designed to provide a "tolerance" in position relative to each other when viewed in a fluoroscopic image, as described in more detail below. FIG. 4A to FIG. 4B In an embodiment of the present invention, and as described in more detail below, when the marker 160A is within the width of the marker 160B in the cusp overlap view, the capsule 150 is rotationally oriented so that the commissure 209 of the heart valve prosthesis 200 is within a 40 degree tolerance angle of the allowable rotation angle θ (θ) with the native right-left commissure 120B. Thus, in an embodiment of a capsule diameter of about 5.56 mm (radius R of about 2.78 mm), and taking into account the allowable rotation angle θ (θ) or the above-mentioned 40 degree (about 0.7 radians) (20 degrees in either direction) tolerance angle, where the marker 160A has a width W1 of about 1 mm, the marker 160B will have a width W2 of about 2.94 mm to function as described below (W2 = allowable rotation angle (about 0.7 radians) x capsule radius (2.78 mm) + W1 = 2.946 mm). Further, in the illustrated embodiment, the marker 160B includes an asymmetric shape, in this example a C-shape, to assist in determining whether the marker 160B is anterior or posterior in a fluoroscopic image with the gantry in the cusp overlap view (also referred to as a "cusp overlap view image"). Those skilled in the art will recognize that other asymmetric shapes may be utilized to assist in determining the orientation of the capsule 150 during implantation.

[0071] In the illustrated embodiment, each of the markers 160 is positioned on the outer surface of the capsule 150 in a known radial relationship relative to the C-shaped paddles 250 on the transcatheter heart valve prosthesis 200. The C-shaped paddles 250 of the transcatheter heart valve prosthesis 200 are axially aligned with one of the three commissures 209 of the valve structure 204. Thus, knowing the radial relationship of the markers 160 on the capsule 150 relative to the C-shaped paddles 250 of the transcatheter heart valve prosthesis 200 enables the user to rotationally align the transcatheter heart valve prosthesis 200 in situ so that when the transcatheter heart valve prosthesis 200 is deployed, the commissures 209 of the transcatheter heart valve prosthesis 200 do not block access to the left coronary artery ostia LCO and the right coronary artery ostia RCO of the native heart valve because the user can determine where the commissures 209 of the transcatheter heart valve prosthesis 200 are located based on the markers 160 of the capsule 150, as will be described in further detail below. However, while described with respect to a radial relationship between marker 160 and C-shaped paddle 250, this is not intended to be limiting, and other features of the transcatheter heart valve prosthesis and its orientation when loaded into the balloon may be utilized.

[0072] With the above understanding of the cusp overlap view, a system and method for rotationally aligning the sac 150 of the delivery system 100, which is equipped with a compressed transcatheter aortic valve prosthesis 200, will now be described. The described systems and methods are with respect to the sac 150 of the delivery system 100 described above, and the transcatheter heart valve prosthesis 200 described above, and the above-mentioned markers 160A and 160B. However, it should be understood by those skilled in the art that the described systems and methods can be used with other sacs, delivery systems, and / or transcatheter heart valve prostheses having more or fewer markers and arranged in different positions. Specific variations will be discussed in more detail below, but are not intended to be limiting.

[0073] In particular, the desired rotational alignment of the capsule 150 and therefore the implanted transcatheter heart valve prosthesis 200 is to ensure that the commissures 209 of the transcatheter heart valve prosthesis 200 do not block access to the left coronary artery ostium LCO and the right coronary artery ostium RCO. In particular, after the transcatheter heart valve prosthesis 200 is implanted, an interventional procedure, such as angioplasty or stent implantation, may need to be performed in one of the patient's coronary arteries. However, if one of the prosthetic valve commissures or prosthetic tissue adjacent thereto blocks the coronary artery, the clinician may not be able to access the coronary artery for post-implantation surgery. In an embodiment described in more detail below, a system and method for rotationally aligning a prosthetic valve commissure (such as one of the commissures 209 of the transcatheter heart valve prosthesis 200) relative to one of the native valve commissures can be sufficient to ensure access to the coronary arteries. Precise alignment of the prosthetic valve / native valve commissures is not required because the goal is access to the coronary arteries. Other benefits of substantially aligned commissures include improved valve durability and thrombosis resistance, and potential alignment of a second transcatheter heart valve prosthesis during a valve-in-valve procedure. In the case of transcatheter aortic valve replacement procedures using 2-dimensional imaging (such as fluoroscopy), determining the rotational position of the prosthetic valve commissure relative to the native valve commissure or the coronary ostia is difficult.

[0074] With the above understanding of the markings 160 on the sac 150 of the delivery system 100, the system and method for rotationally aligning the sac 150 of the delivery system 100 and thus the transcatheter heart valve prosthesis 200 will now be described. As known to those skilled in the art, the transcatheter heart valve prosthesis 200 can be delivered percutaneously via femoral access. In particular, in the example of a self-expanding transcatheter heart valve prosthesis (e.g., the transcatheter heart valve prosthesis 200), the prosthesis is constrained to a radially compressed configuration by, for example, the sac 150 of the delivery system 100. The characteristics of the patient's autologous anatomical structure can be determined before surgery, such as by CT scanning. In particular, a CT scan can be used to locate the coronary artery ostia (LCO, RCO). Using this planning CT, the orientation of the delivery system can be determined before surgery and therefore the orientation of the transcatheter heart valve prosthesis can be determined when the transcatheter heart valve prosthesis is delivered. For example, but not limitation, delivery system 100 may be arranged such that flush port 116 is aligned with C-shaped paddle 250 of transcatheter heart valve prosthesis 200, which is aligned with one of commissures 209 of valve structure 204. Using preoperative CT, the orientation of delivery system features, such as flushing portion 116, that have a known relationship to features of a transcatheter heart valve prosthesis, such as one of commissures 209 of transcatheter heart valve prosthesis 200, may be further defined by the anatomy of the particular patient. Thus, using preoperative planning, the preferred orientation of a delivery system, such as delivery system 100, may be predicted to reduce coronary ostium overlap.

[0075] Further, during the procedure, the coronary artery overlay view and markers 160 can be used to confirm that the transcatheter heart valve prosthesis is rotationally aligned to not cause coronary artery occlusion. Balloon 150 can then be retracted proximally to expose transcatheter heart valve prosthesis 200, thereby allowing transcatheter heart valve prosthesis 200 to self-expand.

[0076] Thus, when delivery system 100 is advanced to the site of a native heart valve (e.g., a native aortic valve), markers 160A, 160B can be used to confirm that capsule 150 is in a desired rotational orientation within the native valve. In particular, the cusp overlap view discussed above can be used to determine whether capsule 150, and therefore transcatheter heart valve prosthesis 200 disposed therein, is properly rotationally oriented.

[0077] FIG. 5A to FIG. 5B Depicted are markings 160A and 160B on the capsule 150 of the delivery system 100 according to an embodiment of the present invention, as shown in FIG. FIG. 4A to FIG. 4B As described in , these markers are in a specific rotational position referred to as the "aligned position." As used herein, the "aligned position" refers to the rotational orientation of the capsule 150 relative to the native aortic valve, and therefore refers to the position of the transcatheter heart valve prosthesis 200 disposed within the capsule 150 relative to the native aortic valve.

[0078] As previously described, markers 160A and 160B are arranged 180 degrees apart from each other on capsule 150. Transcatheter heart valve prosthesis 200 is arranged in a compressed configuration within central lumen 153 of capsule 150. In the depicted embodiment, when transcatheter heart valve prosthesis 200 is loaded into capsule 150 in a compressed configuration, C-shaped paddles 250 of transcatheter heart valve prosthesis 200 are arranged at 90 degrees to both markers 160A and 160B, as shown in FIG. Figure 5A Best shown. Figure 5A The balloon 150 of the delivery system 100 is shown within an exemplary native aortic valve as viewed from the aorta. The balloon 150 includes FIG. 4A to FIG. 4B As can be seen, markers 160A and 160B are arranged on capsule 150 180 degrees apart from each other. With reference to a clock face, marker 160A is located at the 12 o'clock position, while marker 160B is located at the 6 o'clock position. As explained above, transcatheter heart valve prosthesis 200 is arranged in a compressed configuration within central lumen 153 of capsule 150 for delivery. C-shaped paddle 250 of transcatheter heart valve prosthesis 200 is aligned with one of commissures 209 of transcatheter heart valve prosthesis 200. Figure 5A As shown, the C-shaped paddle 250 is located at the 3 o'clock position within the native aortic valve. Figure 5AAs shown, both indicia 160A and 160B are arranged 90 degrees from C-shaped paddle 250 in the opposite direction from C-shaped paddle 250. In other words, indicia 160 of capsule 150 are equally spaced 90 degrees from C-shaped paddle 250, and indicia 160A and 160B are arranged on capsule 150 180 degrees apart from each other.

[0079] As in Figure 5A As can be seen in FIG. 1 , the aligned position aligns the commissures 209 of the transcatheter heart valve prosthesis 200 with the native commissures 120 of the idealized native aortic valve. Thus, the aligned position is a rotational orientation of the capsule 150. When viewed in a fluoroscopic image under the cusp overlap view COVA (“cusp overlap view image”), as shown in FIG. Figure 5B As shown, it will be seen that the marks 160A and 160B are aligned, with the mark 160A being centered within the width of the mark 160B. Figure 5A As can be seen in FIG, when viewed from the cusp overlap perspective COVA, marker 160A is directly behind marker 160. Figure 5B In the 2D cusp overlap view image, it can be seen that the markers 160A and 160B are aligned. Further, due to the longitudinal deviation of the markers 160A and 160B, Figure 5B In the cusp overlap view of the 160A, marker 160A is seen above marker 160B. The C-shape of marker 160B also enables the clinician to confirm that marker 160B is in front of marker 160A. Figure 5B The C-shape marked 160B in the image is backwards, then Figure 5B The one marked in the image 160B will be on the rear.

[0080] Therefore, when the balloon 150 of the delivery system is delivered to the native aortic valve, if the markers 160A, 160B are shown in the cusp overlap view image as the marker 160A is centered above the marker 160B, the clinician knows that the balloon is properly rotationally oriented so that the commissures 209 of the transcatheter heart valve prosthesis 200 will not block the left coronary artery ostium LCO and the right coronary artery ostium ROC. Therefore, the clinician can continue to retract the balloon 150 to deploy the transcatheter heart valve prosthesis 200.

[0081] As discussed above, the arrangement and size of markers 160A, 160B on sac 150 enables the clinician to know whether sac 150, and therefore transcatheter valve prosthesis 200, is within an allowable rotation angle θ (θ) or tolerance angle relative to the native aortic valve by visualizing markers 160A, 160B in the cusp overlap perspective image, as explained in more detail below.

[0082] In particular, FIG. 6A to FIG. 6B A balloon 150 is shown which is placed within the native aortic valve and from which FIG. 5A to FIG. 5B The aligned position of the transcatheter heart valve prosthesis 200 is rotated 20 degrees clockwise. This may also be referred to as the first position. As discussed above with respect to FIG. 4, in embodiments, the commissure 209 of the transcatheter heart valve prosthesis 200 may be rotated away from the native commissure 120 by up to 20 degrees and still be acceptably oriented. Thus, FIG. 6A to FIG. 6B Such a position is shown.

[0083] Fig. 6A A schematic diagram of a native aortic valve viewed from the aorta is shown, wherein the sac 150 including the markings 160A, 160B is shown, and the C-shaped paddle 250 of the transcatheter heart valve prosthesis 200 is also shown. Fig. 6A As can be seen in the figure, capsule 150 is Figure 5A The alignment position is rotated 20 degrees clockwise. Fig. 6A As can be seen in FIG. 2 , the C-shaped paddle 250 and therefore the commissure 209 aligned therewith are spaced 40 degrees from the left coronary ostium LCO and 80 degrees from the right coronary ostium. As discussed above, this is an acceptable position.

[0084] When viewed in 2D coronary artery overlapping perspective images, Figure 6B As shown, this first position is shown as the mark 160A being laterally displaced toward the right edge of the mark 160B, but the right edge of the mark 160A is still within the boundary of the width of the mark 160B, that is, within the right edge of the mark 160B. Further, due to the longitudinal deviation of the marks 160A and 160B, Figure 6B In the cusp overlap view of the 160A, marker 160A is seen above marker 160B. The C-shape of marker 160B also enables the clinician to confirm that marker 160B is in front of marker 160A. Figure 6B The C-shape marked 160B in the image is backwards, then Figure 6B The one marked in the image 160B will be on the rear.

[0085] Similarly, FIG. 7A to FIG. 7B A balloon 150 is shown which is placed within the native aortic valve and from FIG. 5A to FIG. 5B The aligned position is rotated 20 degrees counterclockwise. This may also be referred to as the second position. As discussed above with respect to FIG. 4, in embodiments, the commissure 209 of the transcatheter heart valve prosthesis 200 may be rotated away from the native commissure 120 by up to 20 degrees and still be acceptably oriented. Thus, FIG. 7A to FIG. 7B Such a position is shown.

[0086] Fig. 7AA schematic diagram of a native aortic valve viewed from the aorta is shown, wherein the sac 150 including the markings 160A, 160B is shown, and the C-shaped paddle 250 of the transcatheter heart valve prosthesis 200 is also shown. Fig. 7A As can be seen in the figure, capsule 150 is Figure 5A The alignment position is rotated 20 degrees counterclockwise. Fig. 7A As can be seen in FIG. 2 , the C-shaped paddle 250 and therefore the commissure 209 aligned therewith are spaced 40 degrees from the right coronary ostium RCO and 80 degrees from the left coronary ostium LCO. As discussed above, this is an acceptable position.

[0087] When viewed in 2D coronary artery overlapping perspective images, Figure 7B As shown, this second position is shown as the mark 160A being laterally displaced toward the left edge of the mark 160B, but the left edge of the mark 160A is still within the boundary of the width of the mark 160B, that is, within the left edge of the mark 160B. Further, due to the longitudinal deviation of the marks 160A and 160B, Figure 7B In the cusp overlap view of the cusp, marker 160A is seen above marker 160B. The C-shape of marker 160B also enables the clinician to confirm that marker 160B is in front of marker 160A. Figure 7B The C-shape marked 160B in the image is backwards, then Figure 7B The one marked in the image 160B will be on the rear.

[0088] Thus, given the 20 degree tolerance or allowed rotation angle θ (θ) in either direction (clockwise and counterclockwise) and the size of the capsule, the size of the markers 160A, 160B can be designed so that in the cusp overlap view image, the clinician can determine whether the capsule 150, and therefore the transcatheter heart valve prosthesis 200 disposed therein, is within the allowed rotation angle θ (θ) or tolerance. FIG. 4A to FIG. 4B In the example of the capsule 150 and markers 160A, 160B, when viewed in the cusp overlap view image, if marker 160A is arranged within the boundaries of marker 160B, the clinician can determine that the capsule 150 is within the allowable rotation angle θ (θ), as described above.

[0089] FIG. 8A to FIG. 8BThe markings 160A, 160B of the capsule 150 and the C-shaped paddle 250 of the transcatheter heart valve prosthesis 200 are shown in a misaligned position. The misaligned position of the capsule 150 is defined as any position of the capsule 150 when the capsule 150 is rotated outside the allowed rotation angle θ (θ). As described above, in the example, the allowed rotation angle θ (θ) is defined as a 20 degree rotation tolerance from the aligned position of the capsule 150 in each direction (clockwise and counterclockwise). In other words, the capsule 150 can be rotated a maximum of 20 degrees clockwise or counterclockwise from the aligned position while still within the allowed rotation angle θ (θ). In other words, if the capsule 150 is rotated more than 20 degrees clockwise or counterclockwise from the aligned position, the capsule 150 is in a misaligned position. Deploying the transcatheter heart valve prosthesis 200 when the capsule 150 is in a misaligned position will unacceptably increase the risk that the commissure 209 of the prosthesis 200 blocks at least one of the coronary artery ostia (LCO, RCO).

[0090] Fig. 8A The aorta is shown when the balloon 150 is in a misaligned position (at Fig. 8A 2 is a view of the balloon 150 of the delivery system 100 (from above) within an exemplary native aortic valve. As can be seen, for example, the balloon 150 has been rotated 45 degrees clockwise from the aligned position to show that the balloon 150 is in a misaligned position outside of the allowed rotation angle θ (θ). Fig. 8A In the misaligned position shown, the C-shaped paddle 250 of the transcatheter heart valve prosthesis 200 is also rotated 45 degrees clockwise from the position aligned with the sac 150. In the misaligned position, as shown in FIG. Fig. 8A As shown, marker 160A is rotated 45 degrees clockwise from the 12 o'clock position, marker 160B is rotated 45 degrees clockwise from the 6 o'clock position, and C-shaped paddle 250 of transcatheter heart valve prosthesis 200 is rotated 45 degrees clockwise from the 3 o'clock position. FIG. 8A to FIG. 8B The misaligned positions shown are exemplary in nature and are not intended to be limiting. If capsule 150 is rotated in either direction from the aligned position by any angle greater than the allowed rotation angle θ (θ) (20 degrees in this example), capsule 150 and transcatheter heart valve prosthesis 200 are described as being in a misaligned position outside of the allowed rotation angle θ (θ).

[0091] As in Fig. 8AAs can be seen in FIG, in an idealized native aortic valve, the sac 150 is oriented at 45 degrees in a clockwise direction from the aligned position, and the C-shaped paddle 250 of the transcatheter heart valve prosthesis 200 (which is aligned with one of the commissures 209 of the transcatheter heart valve prosthesis 200) is arranged near the left coronary ostium LCO, thereby having a risk that the valve structure 204 of the transcatheter heart valve prosthesis 200 will block access to the left coronary ostium LCO. Considering that another commissure 209 of the transcatheter heart valve prosthesis 200 is located at a position 120° counterclockwise from the commissure 209 aligned with the C-shaped paddle 250, such a commissure 209 will be located near the right coronary ostium RCO, thereby having a risk that the valve structure 204 of the transcatheter heart valve prosthesis 200 will block access to the right coronary ostium RCO. Such a situation is undesirable.

[0092] When viewed in 2D coronary artery overlapping perspective images, Figure 8B As shown, Fig. 8A The misaligned position shown is manifested by the lateral displacement of mark 160A to the right and the lateral displacement of mark 160B to the left. Figure 8B As can be seen in Figure 1, marker 160A is not within the left and right boundaries of marker 160B. Figure 8B A clinician viewing the cusp overlap perspective image shown in can determine that the capsule 150 is in a misaligned rotational position relative to the native heart valve. In such a position, as explained above, it is undesirable to deploy the transcatheter heart valve prosthesis 200. Therefore, if the capsule 150 is in a misaligned position, the delivery system 100 or at least a portion thereof including the capsule 150 can be rotated so that the capsule is in an aligned position or within an allowed rotation angle.

[0093] therefore, FIG. 4A to FIG. 4B Examples and FIG. 5A to FIG. 8BThe described method enables the clinician to determine whether the capsule 150 is in an acceptable rotational position, thereby determining whether the capsule 150 is within the allowed rotation angle relative to the aligned position. In the embodiment of the capsule 150 with the markers 160A, 160B as described, in the cusp overlap view image, if the marker 160A is between the left and right edges of the marker 160B, the capsule 150 is in the allowed rotational orientation within the native heart valve, making it unlikely that the valve structure 204 will block the left coronary ostium LCO and / or the right coronary ostium RCO. Therefore, the capsule 150 can be retracted to enable the transcatheter heart valve prosthesis 200 arranged therein to be released and deployed within the native heart valve. On the other hand, if the marker 160A is not arranged between the left and right edges of the marker 160B, the capsule 150 is located outside the allowed rotational orientation within the native heart valve, so that there is a risk that the valve structure 204 will block the left coronary ostium LCO and / or the right coronary ostium RCO. In this case, the capsule 150 may be rotated until the marking 160A is located between the left and right edges of the marking 160B.

[0094] Those skilled in the art will recognize that FIG. 4A to FIG. 4B The embodiment of is only an example, but FIG. 4A to FIG. 4B The concepts described can be used in other examples. For example, but not by way of limitation, the size of markers 160A, 160B can vary as the size of the capsule 150 changes and / or the allowed rotation angle changes. However, this concept does not change that the size of markers 160A, 160B is designed and positioned on the capsule 150 so that when viewed in the cusp overlap perspective image, if marker 160A is between the left and right edges of marker 160B, the capsule 150 is sufficiently rotationally aligned so that the transcatheter heart valve prosthesis 200 can be deployed from the capsule 150. On the other hand, if marker 160A is not between the left and right edges of marker 160B when viewed in the cusp overlap perspective image, the capsule 150 is not sufficiently rotationally aligned within the native heart valve. In this case, the capsule 150 can be rotated until marker 160A is between the left and right edges of marker 160B, and then the transcatheter heart valve prosthesis 200 can be deployed therefrom.

[0095] FIG. 9A to FIG. 9B Another embodiment of an imaging marker on the capsule 150 of the delivery system 100 is shown. Fig. 9AA close-up view of the sac 150 of the delivery system 100 is shown. As can be seen, the sac 150 of the delivery system 100 is a tubular structure including a distal end 151 and a proximal end 152. The inner surface of the sac 150 defines a central lumen 153 that extends parallel to the central longitudinal axis CLA of the delivery system 100 and extends the entire longitudinal length of the sac 150, i.e., from the distal end 151 to the proximal end 152. In an embodiment, the sac 150 has a radius R of approximately 2.5-3.0 mm. However, this is not intended to be limiting, and the sac 150 can have a radius (and diameter) required to radially constrain a given transcatheter heart valve prosthesis. Therefore, for a transcatheter heart valve prosthesis having a larger diameter when radially compressed, the sac can have a larger diameter, and for a transcatheter heart valve prosthesis having a smaller diameter when radially compressed, the sac can have a smaller diameter. During delivery to the treatment site, balloon 150 disposed at distal end 103 of delivery system 100 constrains transcatheter heart valve prosthesis 200 into a radially compressed configuration, such as Figure 2B When the delivery system 100 is deployed at the treatment site (in this example, the native aortic valve), the balloon 150 is moved proximally (at Fig. 9A The valve is then withdrawn (center and upward) to reveal the self-expanding transcatheter heart valve prosthesis 200.

[0096] like Fig. 9A As shown, the capsule 150 includes an imaging marker 160 disposed on the capsule 150. More specifically, the imaging marker 160 can be attached to, positioned in, and / or formed in the capsule 150 using any type of process and / or procedure. In any embodiment, the imaging marker 160 can include a radiopaque material or other material that allows the marker 160 to be detected and / or observed under radiography during the implantation of the transcatheter heart valve prosthesis 200 via the delivery system 100. Examples of radiopaque materials include metals such as platinum-iridium, gold, iridium, palladium, rhodium, titanium, tantalum, tungsten, and alloys thereof. Other examples of radiopaque materials include polymeric materials such as nylon, polyurethane, silicone, PEBAX, PET, polyethylene, which have been mixed or compounded with compounds of barium, bismuth, and / or zirconium (e.g., barium sulfate, zirconium oxide, bismuth subcarbonate, etc.). In an embodiment, gold is a preferred marker material due to its visibility. Further, in addition to the radiopaque materials noted above, the imaging marker 160 can be a feature on the balloon 150 of the delivery system 100 that can be seen under fluoroscopy as distinct from other features of the delivery system 100 .

[0097] exist FIG. 9A to FIG. 9B In the embodiment of FIG. 1 , the capsule 150 includes three markings 160C, 160D, and 160E. Fig. 9AAs shown, each of the markings 160C, 160D, 160E is arranged at 120° to the other two markings. In other words, the markings 160C, 160D, 160E are evenly spaced around the circumference of the capsule 150. Fig. 9A , in this particular view, marker 160D is on the "back" of the capsule. Where markers 160C and 160E are each 120 degrees in the opposite direction from marker 160D, markers 160C and 160E may be described as being on the "side" of capsule 150, but as shown, would also be on the "front" half of capsule 105. In a 2-dimensional view, markers 160C and 160E would appear on the left and right sides of capsule 150. Those skilled in the art will recognize that reference is only made to the left and right sides of capsule 150. Fig. 9A The terms "front" and "back" are used to refer to the relative positions of the indicia 160C, 160D, 160E in this view and are not intended to be limiting.

[0098] Further, in FIG. 9A to FIG. 9B In the embodiment of the present invention, the markings 160C, 160D, 160E are aligned with respect to a circumferential line drawn around the circumference of the capsule 150. In other words, the markings 160C, 160D, 160E are arranged at the same longitudinal position on the capsule. In other words, the longitudinal distance from the proximal end 152 of the capsule 150 to each marking is the same, and the longitudinal distance from the distal end 151 of the capsule to each marking is also the same. However, this is not intended to be limiting, and one or more of these markings may be longitudinally offset from the other markings. Further, the longitudinal distance of the markings 160C, 160D, 160E may vary. Therefore, Fig. 9A , 10B , 11B, 12B and 13B are not intended to be limiting. For example, but not limitation, the distance from the distal end of the capsule may be greater or less than Fig. 10B , 11B , 12B and 13B. Fig. 10B , 11B , 12B and 13B, the capsule 150 may also include depth markings 170. In embodiments, the markings 160C, 160D, 160E may be aligned with the depth markings 170, or may be placed in place of the depth markings 170. In such embodiments, the markings 160C, 160D, 160E may be used for depth and rotational orientation, as described below.

[0099] Fig. 9B A close-up view of markers 160C, 160D, 160E is shown. FIG. 9A to FIG. 9BIn an embodiment, each of markers 160C, 160D, 160E is rectangular in shape. However, this is not intended to be limiting, and other shapes may be used. The size of markers 160C and 160D is designed so that when viewed in a cusp overlap view in a fluoroscopic image, the position of markers 160C and 160D relative to each other enables a clinician to determine whether transcatheter heart valve prosthesis 200 is rotationally oriented to avoid obstruction of the ostia of a coronary artery, as described in more detail below. Thus, the size of markers 160C, 160D relative to each other is designed to provide a "tolerance" in position relative to each other when viewed in a fluoroscopic image, as described in more detail below. FIG. 9A to FIG. 9B In an embodiment, and as described in more detail below, when the markers 160C and 160D overlap each other or their width edges touch, the capsule 150 is rotationally oriented so that the commissure 209 of the heart valve prosthesis 200 is within a 40 degree tolerance of the native right-left commissure 120B. Therefore, in an embodiment where the capsule diameter is about 5.56 mm (radius R is about 2.78 mm), and taking into account the allowable rotation angle θ or the above-mentioned 40 degree (about 0.7 radians) (20 degrees in either direction) tolerance angle, each of the markers 160C, 160D has a width W3 of about 0.97 mm (W3 = allowable rotation angle (about 0.7 radians) x capsule radius (2.78 mm) x 0.5). Marker 160E can be the same size as markers 160C, 160D, or can be a different size. Although specific examples are given above regarding the size of the markers, this is not intended to be limiting, and the size can vary depending on the size of the capsule, the allowable tolerance angle, and other factors.

[0100] In an embodiment, marker 160E has a width in the range of 1.0–1.5 mm, but this is not intended to be limiting. Markers 160, 160d, 160E may all have the same length L2, L3, but this is not intended to be limiting. For example, as described in more detail below, in the aligned position, marker 160C obscures marker 160D in the cusp overlap view image. However, in other embodiments, it may be desirable for marker 160D to be longer than marker 160C so that it is clear to see that the two markers are aligned in the image. In an example, the lengths L2, L3 may be in the range of 1 to 8 mm, but this is not intended to be limiting. Although not shown in this embodiment, one of markers 160C, 160D may include an asymmetric shape, such as described above with respect to FIG. 4A to FIG. 4B The C-shape is described to assist in determining whether the marker is anterior or posterior in a fluoroscopic image with the gantry in the cusp overlap view (also referred to as a "cusp overlap view image"). Those skilled in the art will recognize that other asymmetric shapes may be utilized to assist in determining the orientation of the capsule 150 during implantation.

[0101] In the illustrated embodiment, marker 160E is aligned with a C-shaped paddle 250 of transcatheter heart valve prosthesis 200, which is axially aligned with one of the commissures 209 of valve structure 204. With markers 160C, 160D each 120 degrees (in opposite directions) from marker 160E, markers 160C, 160D are also each axially aligned with one of the commissures 209 of valve structure 204. However, this is not intended to be limiting, and any of markers 160C, 160D, 160C may be aligned with a C-shaped paddle 250.

[0102] With the above understanding of the markings 160C, 160D, 160E on the sac 150 of the delivery system 100, the system and method for rotationally aligning the sac 150 of the delivery system 100 and thus the transcatheter heart valve prosthesis 200 will now be described. As known to those skilled in the art, the transcatheter heart valve prosthesis 200 can be delivered percutaneously via femoral access. In particular, in the example of a self-expanding transcatheter heart valve prosthesis (e.g., the transcatheter heart valve prosthesis 200), the prosthesis is constrained to a radially compressed configuration by, for example, the sac 150 of the delivery system 100. The characteristics of the patient's autologous anatomical structure can be determined before surgery, such as by CT scanning. In particular, a CT scan can be used to locate the coronary artery ostia (LCO, RCO). Using this planning CT, the orientation of the delivery system can be determined before surgery and therefore the orientation of the transcatheter heart valve prosthesis can be determined when the transcatheter heart valve prosthesis is delivered.

[0103] For example, but not limitation, delivery system 100 may be arranged such that flush port 116 is aligned with C-shaped paddle 250 of transcatheter heart valve prosthesis 200, which is aligned with one of commissures 209 of valve structure 204. Using preoperative CT, the orientation of delivery system features, such as flushing portion 116, that have a known relationship to features of a transcatheter heart valve prosthesis, such as one of commissures 209 of transcatheter heart valve prosthesis 200, may be further defined by the anatomy of the particular patient. Thus, using preoperative planning, the preferred orientation of a delivery system, such as delivery system 100, may be predicted to reduce coronary ostium overlap.

[0104] Further, during the procedure, the coronary artery overlay view and markers 160C, 160D, 160E can be used to confirm that the transcatheter heart valve prosthesis is rotationally aligned to not cause coronary artery occlusion. The balloon 150 can then be retracted proximally to expose the transcatheter heart valve prosthesis 200, thereby allowing the transcatheter heart valve prosthesis 200 to self-expand.

[0105] Thus, when delivery system 100 is advanced to the site of a native heart valve (e.g., a native aortic valve), markings 160C, 160D, 16E can be used to confirm that capsule 150 is in a desired rotational orientation within the native valve. In particular, the cusp overlap view discussed above can be used to determine whether capsule 150, and therefore transcatheter heart valve prosthesis 200 disposed therein, is properly rotationally oriented.

[0106] FIG. 6A to FIG. 6B Depicted are markings 160C, 160D, 160E on the capsule 150 of the delivery system 100 according to an embodiment of the present invention, as shown in FIG. FIG. 9A to FIG. 9B As described in , these markers are in a specific rotational position referred to as the "aligned position." As used herein, the "aligned position" refers to the rotational orientation of the capsule 150 relative to the native aortic valve, and therefore refers to the position of the transcatheter heart valve prosthesis 200 disposed within the capsule 150 relative to the native aortic valve.

[0107] As previously described, markers 160C, 160D, 160E are arranged 120 degrees apart from each other on the capsule 150. The transcatheter heart valve prosthesis 200 is arranged in the compressed configuration within the central lumen 153 of the capsule 150. In the depicted embodiment, when the transcatheter heart valve prosthesis 200 is loaded into the capsule 150 in the compressed configuration, the C-shaped paddle 250 of the transcatheter heart valve prosthesis 200 is aligned with the marker 160E, as shown in FIG. Fig. 10A Best shown. Fig. 10A The balloon 150 of the delivery system 100 is shown within an exemplary native aortic valve as viewed from the aorta. The balloon 150 includes FIG. 9A to FIG. 9B 160C, 160D, 160E in the embodiment. As can be seen, each mark 160C, 160D, 160E is aligned with one of the autogenous commissures 120A, 120B, 120C. Referring to the clock face, mark 160C is located at the 7 o'clock position, mark 160D is located at the 11 o'clock position, and mark 160E is located at the 3 o'clock position. The C-shaped paddle 250 is also arranged at the 3 o'clock position.

[0108] In the idealized native aortic valve shown, this is the aligned position because each commissure 209 is aligned with a corresponding one of the native commissures 120A, 120B, 120C. Thus, the aligned position is the rotational orientation of the balloon 150 relative to the native aortic valve. When viewed in a fluoroscopic image under the cusp overlap view COVA ("cusp overlap view image"), as shown Fig. 10BAs shown, it will be seen that the markers 160C, 160D are aligned such that the marker 160C, which is on the "front" side based on the viewing angle, completely occludes the marker 160D, which is on the "back" side based on the viewing angle. In the 2-dimensional cusp overlap viewing image, the markers 160C, 160D are each aligned with each other toward the left side of the capsule 150, and the marker 160E is arranged toward the right side of the capsule 150. Although the markers 160C, 160D have been described as having the same length L2 (in Fig. 10B 160D is shown as a height), but the mark 160D can be longer than the mark 160C, so that it is clear to see that they are aligned. Further, although not shown in this embodiment, the mark 160C can include a C-shape, as described above with respect to the mark 160B, to assist in confirming that the mark 160C is in front of the mark 160D, as explained above.

[0109] Therefore, when the balloon 150 of the delivery system is delivered to the native aortic valve, if the markers 160C, 160D are shown in the cusp overlap view image as being aligned and toward the left side of the balloon 150, and the marker 160E is shown toward the right side of the balloon 150, the balloon is properly rotationally oriented so that the commissures 209 of the transcatheter heart valve prosthesis 200 will not block the left coronary artery ostium LCO and the right coronary artery ostium ROC. Therefore, the balloon 150 can be retracted to deploy the transcatheter heart valve prosthesis 200. Further, the marker 160E can be excluded.

[0110] As discussed above, the arrangement and size of markers 160C and 160D on sac 150 enables the clinician to know whether sac 150, and therefore transcatheter valve prosthesis 200, is within the desired rotational orientation tolerance relative to the native aortic valve by visualizing markers 160C, 160D in the cusp overlap perspective image, as explained in more detail below.

[0111] In particular, FIG. 11A to FIG. 11B A balloon 150 is shown which is placed within the native aortic valve and from which FIG. 10A to FIG. 10B The aligned position of the transcatheter heart valve prosthesis 200 is rotated 20 degrees clockwise. This may also be referred to as the first position. As discussed above with respect to FIG. 4, in embodiments, the commissure 209 of the transcatheter heart valve prosthesis 200 may be rotated away from the native commissure 120 by up to 20 degrees and still be acceptably oriented. Thus, FIG. 11A to FIG. 11B Such a position is shown.

[0112] Fig.11A A schematic diagram of a native aortic valve viewed from the aorta is shown, wherein the sac 150 including the labels 160C, 160D, 160E is shown, and the C-shaped paddle 250 of the transcatheter heart valve prosthesis 200 is also shown. Fig.11A As can be seen in the figure, capsule 150 is Fig. 10A The alignment position is rotated 20 degrees clockwise. Fig.11A As can be seen in FIG. 2 , the C-shaped paddle 250 and therefore the commissure 209 aligned therewith are spaced 40 degrees from the left coronary ostium LCO and 80 degrees from the right coronary ostium. As discussed above, this is an acceptable position.

[0113] When viewed in 2D coronary artery overlapping perspective images, Fig. 11B 160E is still toward the right side of the capsule 150 in the cusp overlap view image of the first position. As discussed above, the marker 160 may further include a C-shape to confirm that the marker 160C is in front of the marker 160D.

[0114] Similarly, FIG. 12A to FIG. 12B A balloon 150 is shown which is placed within the native aortic valve and from FIG. 10A to FIG. 10B The aligned position is rotated 20 degrees counterclockwise. This may also be referred to as the second position. As discussed above with respect to FIG. 4, in embodiments, the commissure 209 of the transcatheter heart valve prosthesis 200 may be rotated away from the native commissure 120 by up to 20 degrees and still be acceptably oriented. Thus, FIG. 12A to FIG. 12B Such a position is shown.

[0115] Fig. 12A A schematic diagram of a native aortic valve viewed from the aorta is shown, wherein the sac 150 including the labels 160C, 160D, 160E is shown, and the C-shaped paddle 250 of the transcatheter heart valve prosthesis 200 is also shown. Fig.11A As can be seen in the figure, capsule 150 is Fig. 10A The alignment position is rotated 20 degrees counterclockwise. Fig. 12A As can be seen in FIG. 2 , the C-shaped paddle 250 and therefore the commissure 209 aligned therewith are spaced 40 degrees from the right coronary ostium RCO and 80 degrees from the left coronary ostium. As discussed above, this is an acceptable position.

[0116] When viewed in 2D coronary artery overlapping perspective images, Fig. 12B, the second position is shown with marker 160C laterally displaced to the right and marker 160D laterally displaced to the left, such that the left edge of marker 160C is aligned with the right edge of marker 160D. In other words, markers 160C and 160D are side by side (with marker 160D on the left) with no gap between markers 160C, 160D. Marker 160E is still toward the right side of the capsule 150 in the cusp overlap perspective image of the second position. As discussed above, marker 160 may further include a C-shape to confirm that marker 160C is in front of marker 160D.

[0117] Thus, given the 20 degree tolerance in either direction (clockwise and counterclockwise) and the size of the capsule, the size of the markers 160C, 160D can be designed so that in the cusp overlap view image, the clinician can determine whether the capsule 150, and therefore the transcatheter heart valve prosthesis 200 disposed therein, is within an acceptable rotational orientation tolerance. FIG. 9A to FIG. 9B In the example of the capsule 150 and markers 160C, 160D, when viewed in the cusp overlap view image, the clinician can determine that the capsule 150 is in an acceptable rotational orientation if the markers 160C, 160D are arranged to at least partially overlap or be side by side with no gap therebetween, and the marker 160E is toward the right side of the capsule 150. Thus, the size and arrangement of the markers 160C, 160D provide a simple indication of whether the capsule 150 is rotationally oriented within an acceptable rotational angle.

[0118] FIG. 13A to FIG. 13B Markings 160C, 160D, 160E of capsule 150 and C-shaped paddle 250 of transcatheter heart valve prosthesis 200 are shown in a misaligned position. The misaligned position of capsule 150 is defined as any position of capsule 150 when capsule 150 is rotated outside of the allowed rotation angle θ (θ). As described above, in the example, the allowed rotation angle θ (θ) is defined as a 20 degree rotation tolerance from the aligned position of capsule 150 in each direction (clockwise and counterclockwise). In other words, capsule 150 can be rotated a maximum of 20 degrees clockwise or counterclockwise from the aligned position while still within the allowed rotation angle θ (θ). In other words, if capsule 150 is rotated more than 20 degrees clockwise or counterclockwise from the aligned position, capsule 150 is in a misaligned position. Deploying transcatheter heart valve prosthesis 200 with balloon 150 in a misaligned position would unacceptably increase the risk that commissures 209 of prosthesis 200 would obstruct at least one of the coronary artery ostia (LCO, RCO).

[0119] Fig.13A The aorta is shown when the balloon 150 is in a misaligned position (at Fig.13A2 is a view of the balloon 150 of the delivery system 100 (from above) within an exemplary native aortic valve. As can be seen, for example, the balloon 150 has been rotated 45 degrees clockwise from the aligned position to show that the balloon 150 is in a misaligned position outside of the allowed rotation angle θ (θ). Fig.13A In the misaligned position shown, the C-shaped paddle 250 of the transcatheter heart valve prosthesis 200 is also rotated 45 degrees clockwise from the position aligned with the sac 150. In the misaligned position, as shown in FIG. Fig.13A As shown, marker 160C is rotated 45 degrees clockwise from the 7 o'clock position, marker 160D is rotated 45 degrees clockwise from the 11 o'clock position, and marker 160E and C-shaped paddle 250 of transcatheter heart valve prosthesis 200 are rotated 45 degrees clockwise from the 3 o'clock position. FIG. 13A to FIG. 13B The misaligned positions shown in are exemplary in nature and are not intended to be limiting. If capsule 150 is rotated in either direction from the aligned position by any angle greater than the allowed rotation angle θ (θ) (20 degrees in this example), capsule 150 and transcatheter heart valve prosthesis 200 are described as being in a misaligned position outside of the allowed rotation angle θ (θ).

[0120] As in Fig.13A As can be seen in FIG, in an idealized native aortic valve, the sac 150 is oriented at 45 degrees in a clockwise direction from the aligned position, and the C-shaped paddle 250 of the transcatheter heart valve prosthesis 200 (which is aligned with one of the commissures 209 of the transcatheter heart valve prosthesis 200) is arranged near the left coronary ostium LCO, thereby having a risk that the valve structure 204 of the transcatheter heart valve prosthesis 200 will block access to the left coronary ostium LCO. Similarly, considering that another commissure 209 of the transcatheter heart valve prosthesis 200 is located at a position 120 degrees counterclockwise from the commissure 209 aligned with the C-shaped paddle 250, such a commissure 209 will be located near the right coronary ostium RCO, thereby having a risk that the valve structure 204 of the transcatheter heart valve prosthesis 200 will block access to the right coronary ostium RCO. Such a situation is undesirable.

[0121] When viewed in 2D coronary artery overlapping perspective images, Fig. 13B As shown, Fig.13A The misaligned position shown in FIG. 1 is represented by the mark 160C being toward the left side of the capsule 150, the mark 160D being toward the right side of the capsule 150, and the mark 160E being between the marks 160C and 160D. As discussed above, because the marks 160C and 160D are neither overlapping nor aligned with no gap therebetween (edge ​​to edge), the observation Fig. 13BA clinician viewing the cusp overlap perspective images shown in can determine that capsule 150 is in a misaligned rotational position relative to the native heart valve. In such a position, as explained above, it is undesirable to deploy transcatheter heart valve prosthesis 200. Therefore, if capsule 150 is in a misaligned position, delivery system 100 or at least a portion thereof including capsule 150 can be rotated so that capsule 150 is in an aligned position or within an allowed rotation angle. However, those skilled in the art will recognize that FIG. 13A to FIG. 13B The misaligned position is only one example of a misaligned position, and other misaligned positions will appear in the cusp overlap perspective image as markers 160C, 160C spaced laterally apart with a gap therebetween, so that there is no overlap or no alignment without a gap.

[0122] therefore, FIG. 9A to FIG. 9B Examples and FIG. 10A to FIG. 13B The described method enables the clinician to determine whether the capsule 150 is in an acceptable rotational position, thereby determining whether the capsule 150 is within the allowed rotation angle relative to the aligned position. In the embodiment of the capsule 150 with the markers 160C, 160D, 160E as described above, in the cusp overlap view image, if the markers 160C, 160D overlap or are aligned with no gap therebetween, and the marker 160E is located to the right of the markers 160C, 160D, the capsule 150 is within the allowed rotational orientation within the native heart valve, making it unlikely that the valve structure 204 blocks the left coronary artery ostium LCO and / or the right coronary artery ostium RCO. Therefore, the capsule 150 can be retracted to enable the transcatheter heart valve prosthesis 200 disposed therein to be released and deployed within the native heart valve.

[0123] On the other hand, if the markers 160C, 160D are spaced apart laterally so that there is a gap between them, the capsule 150 is outside the permitted rotational orientation within the native heart valve, so that there is a risk that the valve structure 204 will block the left coronary ostium LCO and / or the right coronary ostium RCO. In this case, the capsule 150 can be rotated until the markers 160C, 160D overlap or are aligned side by side with no gap therebetween. Those skilled in the art will recognize that FIG. 9A to FIG. 9B The embodiment of is only an example, but FIG. 9A to FIG. 9B The concepts described can be used in other examples. For example, but not limitation, the size of markers 160C, 160D can change as the size of capsule 150 changes and / or the allowed rotation angle changes. However, this concept does not change that markers 160C, 160D are sized and positioned on capsule 150 so that when viewed in a cusp overlap perspective image, if markers 160C, 160D overlap or are aligned side by side with no gaps therebetween, then capsule 150 is sufficiently rotationally aligned so that transcatheter heart valve prosthesis 200 can be deployed from capsule 150.

[0124] On the other hand, if markers 160C, 160D are laterally spaced apart from each other so that a gap is observed between them in the cusp overlap perspective image, then balloon 150 is not sufficiently rotationally aligned within the native heart valve. In this case, balloon 150 may be rotated until markers 160C, 160D overlap or are aligned side by side with no gap therebetween, and transcatheter heart valve prosthesis 200 may then be deployed therefrom.

[0125] It should be understood that the various embodiments disclosed herein may be combined into combinations different from those specifically presented in the specification and drawings. It should also be understood that, by way of example, certain actions or events of any process or method described herein may be performed in a different order, may be added, merged, or omitted entirely (e.g., all described actions or events may not be necessary to implement these techniques). In addition, although for clarity, certain aspects of the present disclosure are described as being performed by a single device or component, it should be understood that the techniques of the present disclosure may be performed by a combination of devices or components.

Claims

1. A delivery system comprising: a balloon disposed at a distal end of the delivery system and configured to radially constrain a heart valve prosthesis in a radially compressed configuration for delivery to a treatment site; as well as A plurality of markers are disposed on the capsule, wherein the plurality of markers are sized, shaped, and positioned on the capsule such that when viewed in a cusp overlap perspective image, the markers indicate whether the capsule is in a desired rotational orientation.

2. The delivery system of claim 1, wherein The desired rotational orientation defines an aligned position or a position within an allowed rotational angle of the aligned position.

3. The delivery system of claim 1 or claim 2, wherein: The plurality of markings includes a first marking and a second marking, wherein the first marking and the second marking are spaced 180 degrees apart around a circumference of the balloon.

4. The delivery system of claim 3, wherein: The first mark has a first width and the second mark has a second width, wherein the first width is greater than the second width.

5. The delivery system of claim 4, wherein: When the second mark is between the right edge and the left edge of the first mark in the cusp overlap view image, the capsule is in the aligned position or in the position within the allowed rotation angle of the aligned position.

6. The delivery system according to any one of claims 3 to 5, wherein The first and second markings are longitudinally offset from each other such that one of the first and second markings is closer to a distal end of the balloon than the other of the first and second markings.

7. The delivery system according to any one of claims 4 to 6, wherein The second width is the allowed rotation angle in radians multiplied by the radius of the capsule plus the first width.

8. The delivery system of claim 1 or claim 2, wherein: The plurality of markings include first, second, and third markings spaced 120 degrees apart around a circumference of the balloon, wherein the first, second, and third markings are configured to align with commissures of the transcatheter heart valve prosthesis configured to be received in the balloon.

9. The delivery system of claim 8, wherein: When the first mark and the second mark overlap or are arranged side by side with no gap therebetween in the cusp overlap perspective image, and when the third mark is toward the right side of the capsule in the cusp overlap perspective image, the capsule is in the alignment position or in the position within the allowable rotation angle of the alignment position.

10. The delivery system of claim 8 or claim 9, wherein The first mark and the second mark each have a width approximately equal to the allowed rotation angle in radians multiplied by the radius of the capsule and divided by two.

11. A method for rotationally aligning a balloon of a delivery system containing a transcatheter heart valve prosthesis within a native heart valve, the method comprising: delivering the balloon having the transcatheter heart valve prosthesis disposed therein percutaneously to the native heart valve, wherein the balloon includes a plurality of markers; Obtaining overlapping perspective images of the cusp of the capsule in the native heart valve; determining whether the balloon is in a desired rotational orientation based on the cusp overlap view image and the plurality of markers; and If the cusp overlap view images indicate that the capsule is not in the desired rotational orientation, the capsule is rotated until the capsule is in the desired rotational orientation.

12. The method of claim 11, wherein: The desired rotational orientation includes an aligned position or a position within an allowed rotational angle of the aligned position.

13. The method of claim 11 or claim 12, wherein: The plurality of markings includes a first marking and a second marking, wherein the first marking and the second marking are spaced 180 degrees apart around a circumference of the balloon, and commissures of the transcatheter heart valve prosthesis are spaced 90 degrees from each of the first marking and the second marking.

14. The method of claim 13, wherein: The first mark has a first width and the second mark has a second width, wherein the first width is greater than the second width.

15. The method of claim 14, wherein: The determining whether the capsule is in a desired rotational orientation includes determining whether the second marker is between a right edge and a left edge of the first marker based on the cusp overlap perspective image.

16. The method according to any one of claims 13 to 15, wherein: The first and second markings are longitudinally offset from each other such that one of the first and second markings is closer to a distal end of the balloon than the other of the first and second markings.

17. The method according to any one of claims 14 to 16, wherein: The second width is the allowed rotation angle in radians multiplied by the radius of the capsule plus the first width.

18. The method of claim 11 or claim 12, wherein: The plurality of markings includes first, second, and third markings spaced 120 degrees apart around a circumference of the balloon, and wherein each of the first, second, and third markings is rotationally aligned with a corresponding commissure of the transcatheter heart valve prosthesis.

19. The method of claim 18, wherein: Determining whether the capsule is in the desired rotational orientation includes determining whether the first and second markers overlap or are side by side with no gap therebetween based on the cusp overlap perspective image and whether the third marker is toward the right side of the capsule.

20. The method of claim 18 or claim 19, wherein: The first mark and the second mark each have a width approximately equal to the allowed rotation angle in radians multiplied by the radius of the capsule and divided by two.

Images