Commissural alignment system and method for prosthetic valves - Patents.com

Abstract

A method is disclosed for placing a prosthetic valve in a patient while minimizing misalignment between the commissures of the prosthetic valve and the commissures of the native aortic valve. The AoCA of the native aortic valve of the patient to be treated is measured, and a prosthetic valve having three commissures is crimped onto a delivery system having one or more aligners marked on its outer shaft. The aligners are along the same axis. The crimping is performed using a crimper and / or a verification gauge that includes one or more angle markings. The crimping is performed with one or more aligners facing upwards while one of the commissures of the prosthetic valve is axially aligned with the AoCA identified by one of the angle markings of the crimper / verification gauge. The crimped prosthetic valve is placed while maintaining the aligners facing upwards throughout the placement.

Description

[Technical Field]

[0001] The present invention relates to a system, and more particularly, to a system and method for minimizing misalignment of the commissures of a transcatheter prosthetic heart valve with the commissures of a native heart valve. [Background technology]

[0002] The function of a prosthetic heart valve is to replace a diseased natural heart valve. Replacement surgery can be performed surgically (using open-heart surgery) or percutaneously.

[0003] Surgery involves removing the diseased native heart valve leaflets and reshaping the annulus to accept a prosthetic heart valve. For many years, the definitive treatment for this condition has been surgical repair or replacement of the heart valve through open-heart surgery, but such procedures are prone to numerous complications. Some patients cannot tolerate surgery due to the trauma involved and the duration of extracorporeal blood circulation. As a result, many patients are deemed inoperable and remain untreated.

[0004] Instead of open-heart surgery, a percutaneous catheterization technique has been developed to introduce and implant a prosthetic heart valve into the body. This technique is significantly less invasive than open-heart surgery. In this procedure, the prosthetic valve is crimped onto a balloon at the tip of a flexible catheter, known as a transcatheter heart valve system (THV). The catheter is most commonly introduced into the blood vessels, usually via a peripheral artery (or, more rarely, via a vein). This is most likely the patient's common femoral artery, possibly the axillary, carotid, or subclavian artery. Rarely, the transapical route (through the apex of the heart) or transaortic route (through a vein to the aorta) is considered. The catheter, with the prosthetic valve crimped onto the balloon, is advanced through the blood vessel until the crimped prosthetic valve reaches the implantation site. The valve can be expanded to a functional size at the site of the missing native valve by inflating the balloon. Alternatively, the prosthetic aortic valve may have a self-expanding stent or support frame that expands the valve to its functional size by withdrawing a retaining sheath. The aforementioned prosthetic valve is called a "balloon-expandable" valve, while the latter is called a "self-expandable" valve.

[0005] Transcatheter aortic valve replacement (TAVR) has emerged as a promising treatment for symptomatic severe aortic stenosis, compared with surgical aortic valve replacement (SAVR).

[0006] There is a critical unmet clinical need in transcatheter valvular heart valves (THVs): commissure alignment (CA), which is the alignment of the commissures of the prosthetic heart valve with the commissures of the native aortic valve being treated. THV commissure alignment (CA) is clinically important for several reasons, outlined below. In actual TAVR procedures, CA is not routinely practiced because there is no straightforward method for achieving it. Therefore, CA represents a significant unmet clinical need.

[0007] The present invention aims to address the unmet needs mentioned above. Summary of the Invention [Problem to be solved by the invention]

[0008] The present invention relates to a system and method for achieving prosthetic heart valve (also called THV) positioning, i.e., commissure alignment (CA), such that the commissures of the prosthetic heart valve are minimally misaligned relative to the commissures of the native heart valve, in a novel and user-friendly manner. [Means for solving the problem]

[0009] Potential benefits of CA include (a) improved hemodynamic performance by balancing blood flow dynamics within the neosinus, (b) reduced stress on the valve protrusion and improved long-term durability of the THV, (c) unrestricted access to coronary artery ostia for future reintervention (PCI), and (d) the ability to perform a basilica procedure for future valve-in-valve intervention. The above-mentioned and other features and advantages of the present invention will become more apparent from the following detailed description taken in conjunction with the accompanying drawings.

[0010] The system and method for achieving commissural alignment (CA) is based on the following basic approach. 1. Determination of the commissure alignment angle (AoCA). This angle is entirely dependent on the native aortic valve anatomy of the patient into which the THV (transcatheter prosthetic valve) will be implanted. The method for determining the AoCA is described in the detailed description below. 2. Crimp the THV onto the delivery system so that one commissure of the THV, with the aligner portion facing upward, is axially aligned with the AoCA determined as in 1 above. The method of crimping to achieve this orientation is described in the detailed description below. 3. Placement (implant) of the THV is performed by crimping as described in 2 above, by keeping the aligner facing upwards throughout the procedure. Placement methods are described in the detailed description below.

[0011] This basic approach is applicable to balloon-expandable or self-expandable THVs, as detailed below.

[0012] The foregoing summary, as well as the following detailed description of exemplary embodiments, will be better understood when read in conjunction with the accompanying drawings. For the purpose of illustrating the disclosure, example structures of the disclosure are shown in the drawings. However, the disclosure is not limited to the particular methods and apparatus disclosed therein. Also, those skilled in the art will understand that the drawings are not to scale. Wherever possible, like elements have been numbered identically. [Brief explanation of the drawings]

[0013] [Figure 1] 1 is a schematic diagram of the native aortic root. [Figure 2] This is a schematic representation of the anatomical / AP view of the aortic root, and also shows where to take the Mid-SoV (middle sinus of Valsalva) plane AA. [Figure 3] Figure 3 shows a multislice computed tomography (MSCT) cross section of the central sinus of Valsalva in the short axis direction. Figure 3A is an echo image of the MSCT image in Figure 3. [Figure 4] The MSCT images in Figure 3 are shown schematically. [Figure 5] We describe how to determine the commissure alignment angle (AoCA) using MSCT images using software such as 3mensio®. [Figure 6] We describe how to determine the commissure alignment angle (AoCA) using MSCT images using software such as 3mensio®. [Figure 7] We describe how to determine the commissure alignment angle (AoCA) using MSCT images using software such as 3mensio®. [Figure 8]We describe how to determine the commissure alignment angle (AoCA) using MSCT images using software such as 3mensio®. [Figure 9] We describe how to determine the commissure alignment angle (AoCA) using MSCT images using software such as 3mensio®. [Figure 10] We describe how to determine the commissure alignment angle (AoCA) using MSCT images using software such as 3mensio®. [Figure 11] 11A-11D show clock face diagrams with angle scales superimposed on various anatomical structures. [Figure 12] 12A-12D show clock face diagrams superimposed with angular scales for various anatomical structures. [Figure 13] 13A-13B show clock face diagrams superimposed with angular scales for various anatomical structures. [Figure 14] 14A-14B show superimposed clock face diagrams with angular scales for various anatomical structures. [Figure 15] 1 shows a typical illustrative balloon-expandable prosthetic valve frame in a fluoroscopic view. [Figure 16] A typical delivery system for a balloon-expandable THV is shown. [Figure 17] FIG. 16 shows the proximal end of the delivery system and the handle located at this end. [Figure 18] 17 depicts the distal end of the delivery system of FIG. 16, showing the expandable balloon and tip. [Figure 19A] 1 shows a typical exemplary crimper with angle markings on its surface for crimping a balloon-expandable THV onto the balloon of a delivery catheter. [Figure 19B]1 shows a typical exemplary crimper with angle markings on its surface for crimping a balloon-expandable THV onto the balloon of a delivery catheter. [Figure 19C] 1 shows a typical exemplary crimper with angle markings on its surface for crimping a balloon-expandable THV onto the balloon of a delivery catheter. [Figure 19D] 1 shows a typical exemplary crimper with angle markings on its surface for crimping a balloon-expandable THV onto the balloon of a delivery catheter. [Figure 20] 1 shows the crimper, the balloon-expandable prosthetic valve positioned within the iris opening of the crimper, and the orientation of the balloon catheter being inserted into the iris opening. [Figure 21] 21A-21D show views of the check gauge from different perspectives. [Figure 22] 22A and 22B show views of the confirmation gauge from different perspectives. [Figure 23] Figures 23A and 23B illustrate how to verify the correct positioning of the THV on the balloon of the delivery catheter before final crimping. [Figure 24] 10A-10C illustrate the ideal alignment of the commissures of the THV after placement with the commissures of the native aortic valve using the systems and methods of the present invention. [Figure 25] 1 is an illustration of a typical self-expanding prosthetic heart valve. [Figure 26] 28 shows the distal portion of an exemplary delivery system for the self-expanding prosthetic heart valve of FIG. 27. [Figure 26A] FIG. 28 is a cross-sectional view of a distal portion of the delivery system of FIG. 27. [Figure 26B] FIG. 28 is a fluoroscopic view of the distal portion of the delivery system of FIG. 27. [Figure 27] 1 shows a typical delivery system assembly for a self-expanding THV. [Figure 28]27 shows the distal portion of the delivery system of FIG. 26, displaying a continuous aligner on the outer shaft. [Figure 29] Figures 29A and 29B show the check gauges of Figures 21A-21D and 22A-22B, marked AoCA. Figure 29B shows the check gauges of Figures 21C and 21D with full-width marks. [Figure 30] Figures 30 and 30A show how the distal end of the delivery catheter is inserted into the central opening of the confirmation gauge to orient the holder. [Figure 31] Figures 31, 31A and 31B show how a confirmation gauge can be used to orient a deflated self-expanding THV within the lumen of a delivery catheter. [Figure 32] 32, 32A, and 32B illustrate how a confirmation gauge can be used to orient a deflated self-expanding THV within the lumen of a delivery catheter. DETAILED DESCRIPTION OF THE INVENTION

[0014] The features of the described embodiments are as set forth in the claims, which can be best understood by referring to the following description and the drawings that accompany it.

[0015] Before describing the present invention, certain words and terms are defined as follows: "Include" and "Comprise" and their derivatives refer to an open-ended inclusion. The term "or" is inclusive, meaning and / or. "Coupled" and "Associated" and their derivatives may mean include, include, interconnect, include, contain, connect or be connected, couple, be in communication with, cooperate with, interleave, juxtapose, adjoin, be connected or associated with, have a characteristic, and the like. Definitions of certain words and terms are provided throughout this application, and one of ordinary skill in the art will understand that these definitions apply to past as well as future uses of these words and terms.

[0016] References throughout this application to "one embodiment," "an embodiment," or similar phrases mean that a particular feature, structure, or characteristic is included in at least one embodiment. Thus, appearances of "in one embodiment," "in an embodiment," and similar phrases throughout this specification do not necessarily all refer to the same embodiment and may mean "one or more, but not all, embodiments," unless expressly specified otherwise. The terms "including," "comprising," "having," and variations thereof mean "including, but not limited to," unless expressly specified otherwise. Listing of items does not imply that any or all of the items are mutually exclusive and / or mutually inclusive, unless expressly specified otherwise. Terms in the singular may also refer to the plural unless expressly specified otherwise.

[0017] This description includes many exemplary embodiments that are provided to illustrate general categories of devices. Other alternative designs and variations of these exemplary embodiments are possible and are within the description and scope of the present invention.

[0018] Although the operations of exemplary embodiments of the disclosed methods may be described in a particular sequential order for convenience of description, it should be understood that embodiments of the present disclosure may encompass orders of operations other than the particular sequential order disclosed. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, descriptions and disclosures provided in connection with a particular embodiment are not limited to that embodiment but may be applicable to any embodiment disclosed herein. Moreover, for purposes of simplicity, the accompanying figures may not show the various ways in which the disclosed systems, methods, and apparatus can be used in combination with other systems, methods, and apparatus.

[0019] Furthermore, the described features, advantages, and characteristics of these embodiments may be combined in any suitable manner. Those skilled in the relevant art will recognize that embodiments can be practiced without one or more of the specific features or advantages of a particular embodiment. In other instances, additional features and advantages may be recognized in all embodiments that are not present in a particular embodiment. The features and advantages of these embodiments will become more fully apparent from the following description and appended claims, or may be learned by the embodiments described hereinafter.

[0020] It should be noted that terms such as "prosthetic aortic valve," "prosthetic valve," "prosthetic heart valve," and "transcatheter heart valve" (THV) refer to the same implanted device and are therefore referred to interchangeably throughout the description.

[0021] In describing the systems and methods, "proximal" means toward the operator performing the procedure, and "distal" means away from the operator.

[0022] The present invention discloses a commissure alignment system for transcatheter prosthetic heart valves used to replace diseased native aortic valves. The system and method described herein can be used for both balloon-expandable and self-expandable prosthetic valves, following the same basic procedure. Determine the commissure alignment angle (AoCA). Using the AoCA, crimp the prosthetic valve onto the delivery catheter with the crimper, using the aligner marked on the outer shaft of the catheter, the angle markings on the crimper / verification gauge, and one commissure of the prosthetic valve as a guide. During the entire placement process, the aligner marked on the outer shaft of the delivery catheter must be facing upwards, and the prosthetic valve must be placed (implanted) in the desired position. Although the systems and methods are described separately for balloon-expandable and self-expandable prosthetic valves for clarity, those skilled in the art will readily recognize that the underlying principles used for both types of prosthetic valves are the same.

[0023] The commissure alignment system of the present invention can be used when implanting a balloon-expandable or self-expandable prosthetic aortic valve (transcatheter heart valve, THV) into a patient's body, minimizing misalignment between the commissures of the prosthetic aortic valve and the native aortic valve. The present invention facilitates commissure alignment by introducing novel improvements to the delivery system and crimper. Those skilled in the art will readily appreciate that these changes do not affect the basic design and structural features of the delivery system and crimping system. As is apparent, the improvements are very similar for both balloon-expandable and self-expandable THVs.

[0024] Furthermore, the present invention discloses a crimping method based on the above improvements, which is easy for the user to follow and supports achieving near-perfect alignment of the commissures of the prosthetic heart valve with the native aortic valve.

[0025] The following description is divided into three sections for convenience and to facilitate understanding of the system and method: Determining AoCA based on the patient's aortic root anatomy. · Systems and methods for balloon-expandable prosthetic valves. Self-expanding prosthetic valve systems and methods.

[0026] AoCA decision In the anatomy of a native tricuspid aortic valve, the three commissures (junctions) are at 120° to each other. In the anatomy of a native type 0 bicuspid aortic valve, these commissures are at 180° to each other. Typically, there are three coronary cusps in the aortic root. Ideally, the coronary arteries arise from the coronary cusps.

[0027] The aortic root complex (ARC) is shown diagrammatically in Figure 1. The aortic root complex (ARC) is the first portion of the aorta attached to the heart toward the exit of the left ventricular outflow tract (LVOT). It is part of the ascending aorta (AA), which includes the native aortic valve and other anatomical structures, such as the sinuses of Valsalva (SoV), the aortic junction (SJ), and the coronary arteries. The native aortic valve typically has three cusps. Coronary arteries arise from two of the three cusps near the aortic sinus bulb. The right coronary artery (RCA) ideally arises from the right coronary cusp (RCC), and the left coronary artery (LCA) ideally arises from the left coronary cusp (LCC). The remaining cusps are called "non-coronary cusps" (NCCs) because no coronary arteries arise near these cusps. Typically, all three coronary artery cusps are in different planes, with the non-coronary cusp (NCC) located inferior to either the right coronary cusp (RCC) or left coronary cusp (LCC). In a two-dimensional view, two distinct planes exist. The first plane, located at the origin of the aortic root, is called the "virtual annular plane (VAP)," and the second plane, located at the origin of the ascending aortic root, is called the "aortic root transition (SJ)." During standard TAVR / TAVI procedures under fluoroscopy, the native coronary arteries are positioned so that the hinge points of each cusp are aligned and all three cusps are well separated and in the same plane without parallax. This virtual annular plane (VAP) can be visualized under fluoroscopy (usually by placing a standard 5Fr pigtail catheter in the NCC during aortography) and serves as a guide for optimal placement of the prosthetic valve. Figure 1 shows the aortic root with all three cusps aligned along the virtual annular plane (VAP) and the aortic root transition zone (SJ) and coronary arteries emanating from the cusps.

[0028] Figure 2 shows a schematic representation of the anatomic / AP view (APV) of the aortic root shown in Figure 1. It also shows the location where a mid-SoV (middle sinus of Valsalva) cross-section AA should be taken to determine the AoCA.

[0029] Figure 3 shows a multislice computed tomography (MSCT) fluoroscopic image of the central sinus of Valsalva (see Figure 2) in the short axis direction in the AA plane. Figure 3A shows the echo image seen in Figure 3. As shown in Figure 3, the software draws a virtual circle (VC) around the fluoroscopic image.

[0030] Figure 4 shows the image in Figure 3 in a schematic format for clarity. Figure 4 shows three cusps: the right coronary cusp (RCC), left coronary cusp (LCC), and noncoronary cusp (NCC). The right coronary artery (RCA) and left coronary artery (LCA) arise from the RCC and LCC, respectively, shown as short projections. No arteries arise from the noncoronary cusp (NCC). The native aortic valve has three commissures: the right-lower commissure (RLC), left-lower commissure (LNC), and right-lower commissure (NRC). A virtual circle (VC) drawn by the software is also shown.

[0031] It should be noted that the fluoroscopic image observed on a multislice computed tomography (MSCT) or other equivalent imaging system is a mirror image of the true anatomical / AP view, a point well known to the operating surgeon.

[0032] The present invention discloses a novel method for positioning a prosthetic valve so that its commissures are minimally misaligned with those of the native aortic valve. This method is easily performed by the user. This alignment is achieved by aligning one of the three commissures with the central sinus of the right coronary cusp (RCC) as seen specifically in cross-sectional images derived from MSCT or an equivalent imaging system. Alignment can also be achieved by aligning one of the three commissures of the THV with the central sinus of the LCC or NCC. The method of the present invention can be used with balloon-expandable THVs as well as self-expandable THVs.

[0033] The present invention discloses new additional features that can be easily incorporated into the delivery and crimping system, and also provides a deployment method that incorporates these features, allowing for easy positioning of the prosthetic valve commissures with minimal misalignment with the native aortic valve commissures.

[0034] How to determine the AoCA: First, the "commissural alignment angle" (AoCA) is determined by examining the anatomy of the native aortic valve in the patient's aortic root. This is done using a procedural technique described in detail below. The following steps are described using the central sinus of the right coronary cusp (RCC) as a reference point. However, the central sinus of the LCC or NCC can also be used as a reference point. The AoCA plays a very important role in achieving commissural alignment.

[0035] To illustrate the technique for determining the AoCA, MSCT images are used. However, other similar imaging systems can be used instead of MSCT. For clarity, a schematic diagram of the sinuses of Valsalva (SoV) is also shown in addition to or instead of the MSCT cross-sectional views. Step 1: Using MSCT imaging software (e.g., 3mensio®) or other equivalent software, a transverse cross-sectional image of the central sinus of Valsalva (SoV) is taken. Figure 3 shows the echo image in Figure 3A along with a fluoroscopic image taken by the aforementioned software. The fluoroscopic image in Figure 3 is shown in Figure 4 for clarity. As shown in Figures 3 and 4, the software draws a virtual circle (VC) around the MSCT cross-sectional image of the SoV. Step 2: As shown in Figures 5 and 6, horizontal and vertical centerlines (HCL and VCL, respectively) are drawn on the virtual circle (VC) drawn by the software on the image in Figure 3. The intersection of these centerlines is called the "geometric node of the sinus" (GNS). Figure 6 also shows that the RCA and LCA originate as short processes from their respective apexes. Step 3: Draw a line (L) through the geometric node of the sinus (GNS) toward the geometric midpoint of the right coronary cusp (RCC), as shown schematically in Figure 7. The angle formed between this line and the horizontal centerline (HCL) extending to the right of the GNS is called the "commissural alignment angle (AoCA)." The geometric midpoint of the RCC is labeled 71. Step 4: The angle marking surface (110) is superimposed on the transverse cross-sectional image. For example, as shown schematically in FIG. 11A, the angles of the angle markings in FIG. 7 are expressed in degrees. In this exemplary illustration, the AoCA is approximately 71 degrees. In another exemplary embodiment in FIG. 11B, the angle markings are represented in a more convenient way, for example, in the form of a clock (111) on the transverse cross-sectional image of FIG. 7. In this case, the AoCA is perceived as a "clock angle" and can be represented, for example, as 3:03 in FIG. 11B. The angle markings shown in Figures 11A and 11B cover half the circumference of the virtual circle (VC) drawn by the software. If desired, the angle markings (112, 113) can cover the entire circumference of the virtual circle (VC) drawn by the software, as shown in Figures 11C and 11D. Figure 11C shows the angle markings in degrees, and Figure 11D shows the angle markings in clockwise degrees.

[0036] Figure 7 illustrates one case where the right coronary artery (RCA) originates at the geometric midpoint (70) of the right coronary cusp (RCC) and the left coronary artery (LCA) originates at the geometric midpoint (71) of the left coronary cusp (LCC). Alternatively, the RCA may originate off-center, as shown diagrammatically in Figure 8, where the geometric midpoint of the RCC is 80. Again, the AoCA is the angle between a line drawn from the GNS through the geometric midpoint (80) of the RCC and a horizontal centerline extending to the right of the GNS, as shown in Figure 8. Other exemplary anatomical structures are shown in Figures 9 and 10. In Figure 9, the left coronary artery (LCA) originates off-center from the geometric midpoint of the left coronary cusp (LCC) (90), while in Figure 10, both the right coronary artery (RCA) and the left coronary artery (LCA) originate off-center from the geometric midpoint of the right coronary cusp (RCC) (100) and the left coronary cusp (LCC) (101), respectively. Other possible anatomical variations may exist. In all these cases, regardless of the origin of the coronary arteries, the AoCA is still the angle formed between the line (L) passing through the geometric midpoint of the RCC from the GNS and the horizontal centerline extending from the right side of the GNS. Therefore, this procedure can effectively operate in cases with such anatomical variations.

[0037] In all of the embodiments described above, the AoCA is measured as the angle between a horizontal centerline (HCL) extending from the right side of the GNS and line (L). However, the AoCA can also be measured as the angle between a horizontal centerline extending from the left side of the GNS and line L. Similarly, the AoCA can also be measured as the angle between a vertical centerline extending upward or downward from the GNS and line L. What is important is to measure the AoCA. In such cases, the reference point changes. In the following description, the AoCA is measured between a horizontal centerline extending to the right side of the GNS and line L. Those skilled in the art will readily understand how this method can be used with other reference points.

[0038] Two alternative units for measuring and expressing AoCA are mentioned above, expressed as an angle in degrees and as a clockwise angle. Those skilled in the art will understand that other units for measuring and expressing this angle (i.e., AoCA) are equally valid and may be used. Clockwise angles are a convenient way of measuring and expressing angles. The importance of AoCA will become apparent from the description of the crimper that follows.

[0039] Anatomy varies from patient to patient, and therefore, each patient's anatomy is unique. Therefore, the AoCA must be determined for each patient being treated. Figures 12A, 13A, and 14A show examples of several anatomical variations corresponding to the degrees of the angle relative to the mid-right coronary cusp (Mid-RCC). Figures 12B, 13B, and 14B show examples of the anatomical variations shown in Figures 12A, 13A, and 14A, respectively, corresponding to clockwise degrees. In these exemplary images, the AoCA is measured between the horizontal centerline (HCL) extending to the right of the GNS and line L. These images are illustrative and show a case in which the right coronary artery (RCA) originates at the geometric midpoint of the RCC and the left coronary artery (LCA) originates at the geometric midpoint of the LCC. In other cases, the RCA and LCA may originate off-center, as previously mentioned. Other units for measuring and expressing angles are equally effective. For example, the AoCA in Figure 12A can be expressed as 90°. In the examples of Figures 13A and 14A, this can be expressed as 60° and 120°, respectively. For example, in Figure 12B, the AoCA can be expressed as the 3 o'clock position. In the examples of Figures 13B and 14B, it is shown to be at 3:05 and 2:55, respectively.

[0040] 12C and 12D show angle markings covering the entire imaginary circle (VC) in degrees and clockwise degrees, respectively.

[0041] The above description is given with respect to a specific situation where the AoCA is determined with reference to the geometric midpoint of the RCC. Those skilled in the art will appreciate that the AoCA can also be determined from the geometric midpoint of the LCC or NCC. Note that the AoCA in these cases will differ from that measured with reference to the geometric midpoint of the RCC. The reference then shifts to the LCC or NCC.

[0042] Those skilled in the art will readily appreciate that this method is applicable to various types of bicuspid aortic valve anatomies. The AoCA is similarly determined.

[0043] As will be apparent to those skilled in the art, the method for measuring AoCA does not depend on whether the implanted THV is balloon-expandable or self-expandable, as AoCA is entirely dependent on the anatomy of the patient being treated. Therefore, the method for determining AoCA is applicable to both types of THV. Furthermore, as noted above, the goal is to measure AoCA using any specific reference point.

[0044] Commissure alignment method for balloon-expandable THV Balloon-expandable THV Those skilled in the art will be familiar with various designs of balloon-expandable prosthetic valves, which include, among other components, a radially collapsible and expandable frame. The frame is preferably a scaffolded, cylindrical structure generally formed by multiple rows of circumferentially extending struts, which are connected either directly to each other or by struts extending in a common axial direction. The scaffold structure formed by the struts forms a plurality of cell rows. Numerous balloon-expandable prosthetic valves with various scaffold designs are available on the market and described in the literature. Designs are continually being refined and optimized. Those skilled in the art will readily appreciate that the present invention can be used with any scaffold design. For illustrative purposes, an example of a typical frame for a balloon-expandable THV is shown in FIG. 15. As shown in FIG. 15, a representative frame 150 for a balloon-expandable prosthetic valve includes circumferentially extending strut rows 151 connected by generally vertically oriented struts 152. These struts form cells 153. Additionally, there are commissure attachments 154 to which the commissures of the valve leaflets are attached. Note that Figure 15 is merely an illustration of a frame 150 for a balloon expandable THV.

[0045] The balloon-expandable THV further comprises at least two, and preferably three, leaflets made of animal tissue or synthetic material. The commissures of two adjacent leaflets are attached to commissure attachment portions 154 of frame 150 to form the commissures of the prosthetic valve. Frame 150 can also be made of a metallic or polymeric material.

[0046] The balloon-expandable prosthetic aortic valve may further include an inner skirt and / or an outer skirt. The inner skirt at least partially covers the inner surface of the frame 150. The outer skirt at least partially covers the outer surface of the frame 150.

[0047] Those skilled in the art will readily appreciate that the present invention may be used with any design of balloon-expandable prosthetic valve.

[0048] Balloon-expandable THV delivery system: As mentioned above, to achieve commissure alignment, new additional features must be provided to the delivery system. In this section, we will explain the additional features of the delivery system for balloon-expandable THV, i.e., the balloon catheter.

[0049] Those skilled in the art are familiar with the structure of balloon catheters used to radially expand balloon-expandable devices such as stents and prosthetic valves. An exemplary balloon catheter 160, as shown in FIG. 16 , has a proximal end 170 and a distal end 180, and includes an elongated outer tube 161 (also referred to as an "outer shaft") through which extends coaxially an inner tube (also referred to as an "inner lumen," not shown). These tubes are collectively referred to as "tubes." Each tube has a distal end and a proximal end.

[0050] The proximal ends of these tubes pass through a handle 162 and are attached to a Y-connector 163 that has an exit port 163A for the guidewire and an inlet port 163B for inflation fluid. The guidewire port communicates with the lumen, and the inflation fluid port communicates with the annular space between the two tubes.

[0051] A balloon 164 is attached to the distal end of the outer shaft 161. The lumen passes through the balloon 164 and terminates at a soft tip 165 at the distal end of the catheter. A guidewire enters the guidewire lumen at the distal soft tip 165 of the catheter, passes through the balloon 164 into the lumen, and exits at a Y-connector 163. As previously stated, "proximal" means toward the operator and "distal" means away from the operator.

[0052] The balloon 164 is radially expanded by injecting pressurized inflation fluid into the balloon 164 through the annular space between the outer shaft 161 and the lumen.

[0053] The above description discloses details of an exemplary embodiment of a balloon catheter 160. It should be noted that there may be other designs for the balloon catheter that are considered to be within the scope of the present invention.

[0054] The present invention, as described below, involves novel modifications that can be easily made to a balloon catheter to aid in commissure alignment.

[0055] The outer shaft 161 of the delivery system is provided with one or more markings called "aligners" 166. The embodiment in Figure 16 shows multiple aligners 166 spaced apart from one another. Preferably, they are arranged in a single direction, i.e., equidistant from one another on the same axis. For convenience, the following description refers to multiple aligners. However, it should be understood that a single aligner is also included. The aligners 166 are visible because they are attached to the outer shaft 161 of the delivery system 160. To enhance visibility, the color of the aligners 166 should contrast with the color of the outer shaft 161. If the aligners are made of a radiopaque material, they are visible under fluoroscopy. The aligners can be painted on the outer shaft 161 or a strip of biocompatible material can be applied to the outer shaft 161. If the paint is radiopaque or the strip is made of a radiopaque material, the aligners are visible under fluoroscopy. Alternatively, the aligners can be applied to the outer shaft 161 using a laser beam. Other methods of delivering the aligners are equally effective. The aligners must be biocompatible.

[0056] A preferred embodiment of the delivery system of the present invention has a working length of 120 cm and includes four equally-spaced aligners 166 of equal length. Alternatively, the number of aligners may be greater or less than four, and the spacing between the aligners may not be uniform. Alternatively, a single aligner may be provided as a continuous line extending from the proximal handle to the distal end of the outer shaft. The outer shaft 161 of the preferred embodiment is colored, for example, orange. Therefore, the aligner 166 may be white. The color of the delivery system outer shaft contrasts with the color of the aligners, improving their visibility. The aligners of the preferred embodiment are made of a white, biocompatible strip, preferably radiopaque. The strip can be secured to the outer shaft 161 by known techniques, such as gluing. Alternatively, a white aligner could be painted onto the orange outer shaft 161.

[0057] The aligners 166 are located on a single axis, which helps maintain a specific orientation during delivery system introduction for commissure alignment. These aligners 166 prevent accidental twisting of the delivery system during insertion and also help track the system along the aortic anatomy.

[0058] For example, in a preferred embodiment, there are multiple aligners 166 marked on the proximal handle on the same axis as the axis of a company logo 167 (or other equivalent reference), as shown in Figure 16. This is a convenient way to identify the axis of the aligners 166. Alternatively, as previously mentioned, a single aligner can be used for the entire length.

[0059] 16 shows a delivery system in which the distal portion of the shaft 168 is bent to conform to the shape of the aortic arch. Note that this is only one example, and the delivery system may also have a shaft without a bending option.

[0060] The aligner 166 begins on an axis at the proximal handle 162 (also called the most proximal aligner) and terminates on the same axis at the distal end of the outer shaft 161 (i.e., the most distal aligner) or the proximal end of the balloon 164. FIG. 17 shows a preferred embodiment of the proximal end 170 of the balloon catheter 160. In this preferred embodiment, the aligner 166 follows the same axis as the company logo 167 on the proximal handle 162 and continues on the same axis (i.e., maintaining the same orientation) to the proximal end of the balloon 164 or the distal end 180 of the outer shaft 161, as shown in FIG. 18, which shows the distal end 180 of the balloon catheter 160. This is simply a convenient way to mark the aligner 166. It does not have to be on the same axis as the company logo. Alternatively, there may be a single aligner that begins on an axis at the proximal handle and terminates on the proximal end of the balloon 164.

[0061] Those skilled in the art will recognize that marking the aligner 166 on the outer shaft as described above is a novel method and does not affect the design parameters or performance of the delivery catheter.

[0062] Crimper: As mentioned above, achieving commissure alignment requires additional novel features in the crimper. This section describes these additional features of the crimper.

[0063] A typical crimper 190 for a balloon-expandable prosthesis such as a THV is shown in FIG. 19A. The exemplary crimper 190 has multiple jaws 191 arranged within a housing 192 to form a generally circular iris opening 191A. A typical crimper has at least six, and typically 12, jaws. However, a crimper may have any number of jaws, such as six or more. The housing 192 houses a mechanism for synchronously moving the jaws, thereby changing or adjusting the diameter of the iris opening 191A formed by the jaws while maintaining its generally circular (i.e., regular polygon) shape. The mechanism is operated by a handle 192A. Moving the handle 192A activates the mechanism. Initially, the handle is in a position (typically facing upward) that maximizes the diameter of the iris opening 191A. The prosthetic valve, in at least a partially inflated state, is placed over the deflated balloon of the delivery catheter and inserted into an open iris opening 191A large enough to accommodate the balloon and prosthetic valve. The handle is moved (usually downward) to activate a mechanism that moves the jaws 191, gradually reducing the diameter of the iris opening 191A formed by the jaws 191. The reduced opening diameter radially reduces the diameter of the prosthetic valve frame, crimping the valve onto the balloon.

[0064] The crimper described above is one example, and the procedures described here are applicable to other types of crimpers that operate on similar principles.

[0065] Those skilled in the art are familiar with crimping procedures and various designs of crimpers. Traditionally, attention has not been paid to the orientation of the commissures of a prosthetic valve when crimping the valve onto a balloon. Therefore, no conscious effort has been made to achieve commissure alignment. The novel modifications described below can be easily made to conventional crimpers to achieve commissure alignment. Those skilled in the art will readily appreciate that these modifications do not affect the basic design or operation of the crimper.

[0066] In the present invention, a conventional crimper can have angle markings 193, expressed in degrees, on at least one outer surface around a central opening 194 of the crimper, as shown in Figure 19A. These angle markings 193 should correspond to the angle markings on the transverse cross-sectional image of the mid-sinus of Valsalva (mid-SoV) in Figures 11A, 12A, 13A, or 14A.

[0067] Alternatively, the angle markings 193 can be expressed as clockwise degrees, as shown in embodiment 190A of FIG. 19B, corresponding to the angle markings 193 shown in FIG. 11B, 12B, 13B or 14B.

[0068] In the above-described embodiment, the angle markings 193 cover half the circumference of the central opening 194 of the crimper. The angle markings 193 may also cover the entire circumference of the central opening 194 of the crimper, as shown in FIGS. 19C and 19D. The angle markings 193 in FIG. 19C are expressed in degrees, while in FIG. 19D they are expressed in clockwise degrees. It should be understood that these angle markings correspond to the angle markings on the transverse images of the mid-sinus of Valsalva (mid-SoV) ( FIGS. 11A-11D , 12A-12D , 13A / 13B , and 14A / 14B ).

[0069] As previously mentioned, any other method of measuring and expressing the angle is equally valid, including markings on the exterior surface of the crimper, provided that the angle markings 193 on the crimper correspond to the angle markings on the transverse image of the mid-sinus of Valsalva (mid-SoV).

[0070] Angle markings can be provided on both sides of the crimper for convenience for both right and left handed users.

[0071] Steps to achieve commissure alignment Using the AoCA determined by the above method, the aligner 166 of the delivery system described above, and the angle markings 193 on the crimper, the surgeon can achieve commissure alignment in a simple manner, as described in the following procedure. This procedure uses the very convenient clockwise angle as the basis for achieving commissure alignment. However, those skilled in the art will understand that measuring and expressing the AoCA in degrees or other ways is equally effective, can be used in practice, and falls within the scope of the present invention. It should be understood that the following procedure is performed under sterile conditions.

[0072] The procedure described is for a trileaflet valve with three commissures arranged at 120 degrees from each other, but the method is also applicable to bileaflet valves with two commissures and other anatomical variations according to the Siebers classification of bicuspid aortic valves.

[0073] The step-by-step procedure is as follows: 1. Determine the patient's AoCA using the procedure described above and calculate the corresponding clockwise angle. 2. Place a crimper with angle markings 193 expressed as clockwise degrees on the preparation table and open the iris opening 191A by turning the handle of the crimper. 3. Position the ready-to-crimp prosthetic valve 201 at least partially across the iris opening 191A of the crimper so that one of the commissures of the prosthetic valve is aligned with the AoCA (determined in step 1), as shown in Figure 20. To hold the prosthetic valve 201 in this position, the diameter of the iris opening 191A can be reduced by manipulating the handle 192A until the iris opening 191A presses slightly against the outer surface of the prosthetic valve 201. This will hold the prosthetic valve in this position until it is crimped. 4. As shown in FIG. 20, place the deflated balloon 164 of the delivery system at least partially across the prosthetic valve (held within the iris opening of the crimper) with the distal aligner 166 facing upward. The aligner 166 must always face up regardless of AoCA. If the aligner 166 is not present, the system can be held with the proximal handle 162 and company logo 167 facing up. Optionally, a tool can be provided to hold the catheter shaft in place until the crimping process is complete, ensuring that the aligner always faces upwards. Such a tool can be designed by one skilled in the art. 5. Align one of the commissures of the prosthetic valve with the clockwise angle corresponding to the AoCA and crimp the prosthetic valve onto the balloon of the delivery system while keeping the aligner facing upward on the outer shaft of the catheter. 6. Before fully crimping the THV, it is recommended to check the orientation of the prosthetic valve and catheter shaft. At this stage, the prosthetic valve should be crimped enough to allow rotation around the catheter balloon for fine adjustments if necessary. A check gauge can be used for this purpose. FIGS. 21A-21D show four alternative configurations of an exemplary confirmation gauge 210. The preferred embodiment of the confirmation gauge 210 is a square block 211 with a central opening 212 large enough to insert a partially crimped valve with a balloon. As shown in FIG. 21A, angle markings 213A are provided around the perimeter of the central opening 212. These angle markings 213A correspond to angle markings 110 on the software images (e.g., FIGS. 11A, 12A, 13A, and 14A) and angle markings 193 on the crimper (e.g., FIG. 19A). The angle markings 213A are provided on at least one side of the block (e.g., side A) from the location where the crimped THV will be inserted into the central opening. Optionally, angle markings 213A can be provided on both sides (side A and side B) of the exemplary confirmation gauge 210, with care taken to ensure that they correspond exactly to each other. The preferred embodiment of the exemplary confirmation gauge 210 depicted in Figure 21A has angle markings 213A in degrees. The embodiment of Figure 21B has angle markings 213B in clockwise degrees. In both of these embodiments, angle markings 213A and 213B cover half the circumference of central opening 212. However, as previously mentioned, any other method of angle marking would be equally effective. In the alternative embodiments shown in Figures 21C and 21D, angle markings 213C and 213D, respectively, cover the entire circumference of central opening 212. The angle markings are expressed in degrees (213C) in Figure 21C and in clockwise degrees (213D) in Figure 21D. In either case, the angle markings on the verification gauge should correspond with the angle markings 193 on the crimper. Side and cross-sectional views of the exemplary confirmation gauge 210 of Figures 21A and 21B are shown in Figures 22A and 22B, respectively. Figures 21C and 21D, which are cross-sectional and side views of the illustrated embodiment, are similar with angle markings covering the entire circumference of the central opening 212. The check gauge can be made of any suitable material, such as metal or polymeric material. In a preferred embodiment, the check gauge is square in shape, although it can be rectangular, circular, or other shapes. The partially crimped THV (232) with the catheter balloon (164) is removed from the crimper's iris opening 191A and inserted into the central opening 212 of the confirmation gauge 210 with the distal aligner facing upward, as shown in FIGS. 23A and 23B. For illustrative purposes, the angle marking 213B on face A of the confirmation gauge is represented as a clockwise angle covering half the circumference of the central opening 212. The position of one of the commissure regions of the THV 232 should align with the angle marking 213B corresponding to the AoCA (clockwise angle in this exemplary embodiment). If this is not the case, the orientation of the THV 232 can be corrected and adjusted so that one of the commissure regions of the THV 232 aligns with the angle marking 213B corresponding to the AoCA. The balloon 164, along with the partially crimped THV 232, is removed from the confirmation gauge. The THV 232 is completely and securely crimped onto the balloon 164 using a crimper. 7. After the THV is fully crimped, operate the handle 192A to open the crimper iris opening 191A. Remove the balloon 164 with the crimped prosthetic valve from the crimper iris opening. The system is now ready for introducing the catheter into the patient's vasculature (usually the femoral artery) through the recommended introducer sheath. Other routes mentioned above can also be used. 8. The distal end of the catheter with the crimped valve prosthesis on the balloon is inserted through the introducer sheath into the patient's vascular system with the aligner 166 facing upward. If no aligner is present, the system can be held with the proximal handle and company logo facing upward. The orientation of this aligner 166 must not be changed during the placement procedure. Therefore, the surgeon is required not to twist the delivery system. The aligner 166 actually helps the surgeon untwist the delivery system if it is accidentally twisted due to anatomical issues. However, the system can be bent if it is equipped with a bending mechanism. 9. As the prosthetic valve and balloon pass through the aortic annulus, one of the prosthetic valve's commissures is expected to orient toward its own commissure. The other commissures of the prosthetic valve automatically align toward their other commissures. The prosthetic valve is then implanted using standard surgical techniques. The expected final implantation state with commissure alignment 241 under ideal conditions is shown in Figure 24. Figure 24 shows a case in which the prosthetic valve commissure was aligned with the native NCC-LCC commissure using the mid-right coronary cusp (mid-RCC) technique. In practice, only slight misalignment occurs. Those skilled in the art will readily appreciate that this method is applicable to various types of bicuspid aortic valve anatomies.

[0074] Commissure alignment method for self-expanding THV Those skilled in the art will recognize that self-expanding prosthetic valves are different from balloon-expandable prosthetic valves. The delivery system for a self-expanding prosthetic valve is different from that for a balloon catheter. Therefore, the procedure for crimping a self-expanding prosthetic valve onto a delivery catheter is different from that for a balloon-expandable prosthetic valve. However, the basic principles for achieving commissural alignment for a self-expanding prosthetic valve remain the same as for the balloon-expandable prosthetic valve described above. To achieve the goal of commissural alignment for a self-expanding prosthetic valve, we provide novel, easily implemented additions to the delivery system and crimping method.

[0075] Self-expanding prosthetic valves: A self-expanding prosthetic valve consists of a generally tubular frame (although the diameter may vary along its axial length) made of a shape-memory alloy, such as a nickel-titanium alloy, e.g., nitinol, or a polymer with shape-memory properties. Numerous self-expanding prosthetic valves with various scaffold designs are commercially available and described in the literature. Designs are continually being refined and optimized. Those skilled in the art will readily appreciate that the present invention can be used with any scaffold design. A typical illustrative frame 250 of a self-expanding prosthetic valve is shown in FIG. 25. The frame has commissure attachment points to which the commissures of two adjacent valve leaflets attach. An example of such a commissure attachment point (251) is shown in FIG. 25. The shape memory imparted to the frame allows the frame to self-expand to a predetermined diameter when the restraining force applied to collapse the valve is removed from its radially folded state, in which the metal material is in the martensitic phase, typically achieved at low temperatures (typically an ice-water bath), and the valve is exposed to blood flow, resulting in a higher temperature at which the frame metal transforms to the austenitic phase.

[0076] The self-expanding THV further comprises at least two leaflets (not shown), preferably three leaflets, made from animal tissue or synthetic material, with the commissures of two adjacent leaflets attached to frame 250 at commissure attachment portions 251 of frame 250 to form the commissures of the valve.

[0077] Additionally, the prosthetic valve may include an inner skirt and / or an outer skirt as described for the balloon-expandable prosthetic valve (not shown).

[0078] The outflow end A of the frame 250 is provided with at least one, and preferably at least two, eyelets, loops, or retainers (252) that capture the tabs or paddles and fit into receptacles provided within the delivery system to secure the prosthetic valve to the catheter (described below).

[0079] Those skilled in the art are familiar with the various designs of self-expanding prosthetic valves. The frame 250 shown in Figure 25 is exemplary.

[0080] As shown in FIG. 25, the frame 250 of an exemplary self-expanding THV has a tubular shape. The frame 250 includes a proximal end, a distal end, and an axis transverse to the proximal and distal ends. The frame in the embodiment shown in FIG. 25 has a varying diameter along its axial length. However, the frame may have other shapes, such as an hourglass shape, a uniform diameter tube, etc. An example of a commissure attachment portion 251 of the frame 250 is also shown in FIG. 25.

[0081] In the exemplary embodiment of the aortic valve prosthesis shown in Figure 25, the outflow end of the frame is provided with two loops (252). Note that in this embodiment, neither of the loops (252) is aligned (i.e., on the same axis) with any of the commissure attachments (251) on the frame. For commissure alignment, it is desirable for at least one of the loops (252) to be aligned with one of the commissure attachments (251) on the prosthesis.

[0082] Those skilled in the art will readily appreciate that the present invention may be used with any self-expanding prosthetic valve with any scaffold design.

[0083] Delivery system for self-expanding THV: As mentioned above, achieving commissural alignment requires the incorporation of new additional features into the delivery system. This section describes these additional features in the delivery system, i.e., the self-expanding THV catheter.

[0084] The self-expanding THV delivery system consists of a catheter and a loading system. The loading system is used to load the prosthetic valve onto the catheter shaft in a radially contracted or compressed state. Those skilled in the art are familiar with the various designs of self-expanding THV delivery systems. The commissure alignment method described herein is applicable to all commercially available designs of self-expanding THV delivery systems.

[0085] Figure 26 shows the distal portion of a typical illustrative delivery catheter 260 for a self-expanding prosthetic valve such as a THV. Figure 26A shows a cross-sectional view and Figure 26B shows a fluoroscopic view of the distal portion of delivery catheter 260 of Figure 26, with "A" indicating the distal end and "B" indicating the proximal end.

[0086] It should be noted that the distal portion 260 of the delivery catheter shown in Figures 26, 26A, and 26B is illustrative. Those skilled in the art will be familiar with the fact that while there are various designs of delivery catheters, the operating principles are similar. A conventional delivery catheter for a self-expanding THV generally comprises an elongated outer shaft 261, a midshaft 262 coaxially extending through the outer shaft 261, and an inner lumen 263 coaxially extending through the midshaft 262. An atraumatic tip 264 is typically attached to the distal end of the inner lumen 263. A handle is provided at the proximal end of the delivery catheter (not shown in Figures 26, 26A, and 26B). The outer shaft 261, midshaft 262, and inner lumen 263 (collectively referred to as "tube") extend to the proximal end of the catheter and into the handle. The inner lumen 263 functions as a guidewire lumen. The outer shaft 261 is axially and linearly slidable relative to the intermediate shaft 262. The intermediate shaft 262 and inner lumen 263 are fixed and cannot slide relative to one another. These tubes cannot rotate relative to one another. The sliding mechanism for the outer shaft 261 is typically housed in the proximal handle. The handle may also include other mechanisms necessary for manipulating the delivery catheter. As noted above, this description is exemplary and general. Delivery catheters with alternative design features are within the scope of the present invention.

[0087] Typically, the outer shaft 261 of the catheter is placed over the prosthetic valve to hold it in a radially collapsed (compressed) state. Alternatively, a retainer sheath is provided that covers the prosthetic valve to hold it in a radially collapsed (compressed) state.

[0088] The self-expanding THV typically attaches to the distal end of the inner lumen 263 in a radially collapsed (compressed) state in a region 263A located near and proximal to the distal tip 264 (prosthetic valve not shown). The outer shaft 261 is configured to cover the radially collapsed prosthetic valve, thereby holding the prosthetic valve in the compressed state. Other delivery catheter designs may include a retainer sheath that covers the self-expanding THV in its radially collapsed state. The prosthetic valve can be exposed and allowed to self-expand by gradually retracting the outer shaft 261 or retainer sheath proximally. A handle at the proximal end of the catheter typically houses a mechanism for moving the outer shaft 261 or retainer sheath in a controlled manner. As previously mentioned, the tube and retainer sheath (if present) cannot rotate relative to one another.

[0089] The delivery system 260 may optionally include a mechanism for bending the distal portion of the catheter shaft to facilitate navigation through the aortic arch, and the bending mechanism may be housed in a handle at the proximal end.

[0090] Typically, the midshaft 262 includes a hub or holder 265. In this embodiment, the distal end of the holder 265 is flush with the distal end of the midshaft 262. As shown in FIGS. 6, 26A, and 26B, the prosthetic valve is mounted in a radially folded (compressed) state in the inner lumen 263 in the space 263A between the proximal end of the tip 264 and the distal end of the holder 265. The proximal end of the prosthetic valve mounted in a radially folded state in the inner lumen may contact the distal end of the holder 265. The function of the holder 265 is to maintain the position of the prosthetic valve. Typically, as described above, the frame 250 of the prosthetic valve has at least one, and preferably at least two, loops or eyelets (252) on one end. The distal end of the holder 265 is provided with a corresponding number of tabs / paddles (265A) that fit into the loops / eyelets (252) of the frame 250. Alternatively, the distal end of the holder 265 is provided with a corresponding number of receiving areas for receiving the loops / eyelets (252) of the radially collapsed prosthetic valve. When the prosthetic valve is installed in the inner lumen in a radially collapsed state, the loops / eyelets (252) of the frame 250 engage with the tabs / paddles / receiving areas (265A) of the holder 265. This arrangement limits axial and rotational movement of the radially collapsed THV and maintains its position relative to the catheter shaft. The exemplary embodiment in Figures 26, 26A, and 26B shows a holder 265 with receiving areas 265A for receiving the loops / eyelets (252) of the frame 250.

[0091] The holder 265 is not rigidly fixed to the midshaft 262 or the inner lumen 263 and is rotatable relative to the midshaft 262 and the inner lumen 263. As shown in FIGS. 26, 26A, and 26B, a locking screw 265B is provided on the holder 265 and is used to fix the position of the holder 265 and limit rotation and movement of the holder 265 relative to the midshaft 262 and the inner lumen 263. Those skilled in the art will recognize various other methods for locking and unlocking components, such as a holder, attached to a shaft, such as an inner lumen. In the exemplary embodiment illustrated, locking is achieved by tightening the screw 265B. Loosening the screw 265B unlocks the holder 265, allowing it to rotate freely.

[0092] The outer diameter of the holder 265 (including the threads attached to the inner lumen) is smaller than the inner diameter of the outer shaft 261 and retainer sheath (if provided), allowing the outer shaft 261 / retainer sheath to slide over the holder 265.

[0093] FIG. 27 illustrates the assembly of a typical delivery catheter 270, the distal portion 260 of which is shown in FIGS. 26, 26A, and 26B, as discussed above. Note that the delivery catheter of FIG. 27 is merely exemplary. Other delivery catheter designs are contemplated by the present invention. The embodiment of FIG. 27 shows an outer shaft 261 encasing a prosthetic valve (not shown) in a radially collapsed (compressed) state at its distal end A, proximal to the tip 264. As previously discussed, the prosthetic valve can also be encased by a retaining sheath instead of the outer shaft. The proximal end B of the delivery catheter includes a handle 271, which houses various mechanisms for functioning the delivery catheter. Points for flushing the shaft / tube of the delivery system may be provided on the handle. Two exemplary flushing points 272A and 272B are shown in FIG. 27.

[0094] Delivery catheter systems for self-expanding THVs typically include a loading system. Prior to the procedure, the operator can manually compress the prosthetic valve onto the inner lumen and encase it with an outer shaft or retainer sheath. The loading system typically consists of one or more conical, tubular components that help gradually reduce the diameter of the prosthetic valve. This operation is typically performed at low temperatures, typically in an ice-water bath, to transition the shape-memory alloy to a martensitic state, reducing the diameter of the prosthetic valve without distorting the struts. As described above, the prosthetic valve is compressed onto the inner lumen 263 at the designated location 263A and then encased in the outer shaft 261 or retainer sheath, holding it in a crimped position at region 273. Accessories may be available to further assist the crimping procedure. Different manufacturers of self-expanding devices, such as THV systems, offer different loading system designs. Those skilled in the art are familiar with the various loading systems offered by suppliers of self-expanding THVs.

[0095] A self-expanding THV is deployed by gradually retracting the outer shaft 261 or retaining sheath proximally, allowing the prosthetic valve to self-expand at body temperature. As noted above, this operation is typically controlled with the help of a mechanism provided as part of the proximal handle 271.

[0096] Several self-expanding prosthetic valves are available on the market with various designs of delivery catheters and loading system components. However, the basic method of loading and introduction is similar. All of these loading systems have one or more conical tubular components that play a key role in reducing the diameter of the prosthetic valve.

[0097] A self-expanding prosthetic valve delivery catheter may optionally include a bending mechanism that allows the distal portion of the catheter shaft to bend to facilitate passage through the aortic arch.

[0098] The basic principles described above for balloon-expandable prosthetic valves can also be applied to achieve commissural alignment for self-expanding prosthetic valves. Achieving commissural alignment for self-expanding THVs requires the following additional modifications. These modifications do not alter the system design:

[0099] The outer shaft 261 of the self-expanding THV delivery catheter 270 is provided with one or more aligners 266, similar to the method previously described for the balloon-expandable THV delivery system. If multiple aligners 266 are provided, they are spaced apart, preferably equidistant from one another, in a single direction, i.e., on the same axis, as described above for the balloon-expandable THV delivery system. A convenient way to mark the aligner 266 is along the same axis as the company logo on the proximal handle 271 and to follow the same axis (i.e., maintain the same orientation) throughout. This is merely a convenient way to mark the aligner 266. It does not have to be on the same axis as the company logo. FIG. 26 illustrates an embodiment showing one of multiple aligners 266 at the distal end 260 of the outer shaft 261. Note that the outer shaft 261 may alternatively include a single continuous aligner 266A instead of multiple aligners 266, as shown in FIG. 28, which illustrates the distal end portion of the delivery catheter 270.

[0100] The distal end of the single or most distal aligner 266 / 266A on the catheter shaft 261 terminates at the distal end of the outer shaft 261. If a retaining sheath is provided, the aligner 266 / 266A may also be provided on the retaining sheath.

[0101] The various alternative methods of applying aligners described above for balloon-expandable THV delivery catheters, such as painting, applying strips, laser marking, and other methods known in the art, are also applicable to self-expanding THV delivery catheters. The color of the aligner can contrast with the color of the outer shaft to enhance visibility of the plane. The aligner can be radiopaque and visible under fluoroscopy. As described above with respect to the balloon-expandable THV delivery system, when multiple aligners 266 are attached to the outer shaft 261, they can be spaced apart from one another in a single orientation, i.e., preferably equidistant from one another and on the same axis.

[0102] As previously mentioned, and still shown in FIG. 25 , the frame 250 of the self-expanding prosthetic valve has loops / eyelets 252 at its outflow end A. To achieve commissure alignment, a convenient method is to axially align at least one of the loops / eyelets 252 of the frame 250 with one of the commissures 251 of the THV. To distinguish this loop / eyelet 252 from the other loops / eyelets, this loop / eyelet may be provided with a distinctive marking. These distinctive markings should be easily identifiable visually.

[0103] Exemplary loop / eyelet identification markings 311 are shown in Figure 31A. The sole purpose of the identification markings is to distinguish loops / eyelets that are axially aligned with one of the THV's commissures 251. Therefore, other methods of providing the loop / eyelet identification markings may also be used.

[0104] If at least one of the loops / eyelets 252 on the frame is not axially aligned with one of the commissures 251 of the THV, then orienting the crimped valve becomes a little more complicated, as explained below.

[0105] The balloon-expandable THV system has been described above, and the confirmation gauge 210 shown in Figures 21A-21D and 22A / 22B plays a direct role in the self-expandable THV. As described above, angle markings 213A-D are provided on at least one side of the confirmation gauge 210. The role of the confirmation gauge 210 will be explained in the crimping method described below.

[0106] Crimping method for self-expanding THV Those skilled in the art are familiar with the procedure for crimping a self-expanding THV. Traditionally, when attaching a THV to the shaft of a delivery catheter 270, no attention has been paid to the orientation of the commissures 251 of the frame 250. Therefore, no conscious effort has been made to achieve commissure alignment. The following outlines a step-by-step method for crimping a self-expanding THV to achieve commissure alignment. 1. Determine the patient's AoCA using the same method as described above. This method is independent of the type of THV (balloon-expandable or self-expandable). To demonstrate this method, we assume that the measured AoCA is an obtuse angle, as shown in Figures 14A / 14B. 2. Identify the AoCA on exemplary angle markings 213B or 213D on the confirmation gauge 210. FIGS. 29A and 29B show two exemplary embodiments of a confirmation gauge with clockwise angle markings covering half the circumference of the central opening 212 in FIG. 29A and the entire circumference of the central opening 212 in FIG. 29B. The AoCA may be identified thereon by placing marks 291A / 291B on the confirmation gauge, as shown in FIGS. 29A and 29B. Note that any other angle marking method (such as degrees) is equally valid. Also, other methods of identifying the AoCA on the confirmation gauge are equally valid. 3. As shown in Figure 30, the distal end 260 of the delivery catheter 270 is inserted into the central opening 212 of the confirmation gauge 210 from one side of the confirmation gauge 210, with a portion of the outer shaft 261 of the delivery catheter 270 and the holder 265 protruding from the other side of the confirmation gauge 210. This arrangement is shown enlarged in Figure 30A for clarity. The holder 265 can be held in a locked position. The catheter is positioned with the aligner 266 / 266A facing upward, as shown in Figures 30 and 30A. 4. This step is performed with at least one of the loops / eyelets 252 of the frame 250 axially aligned with one of the commissures 251 of the THV and bearing the identifying marking 311. The holder 265 is unlocked, for example, by loosening the locking screw 265B of the holder 265. The holder 265 is rotated on the intermediate shaft 262 so that one of the tabs / paddles or receptacle areas on the holder 265A aligns with the AoCA marking 291A on the confirmation gauge 210, as shown in FIG. 30. For clarity, FIG. 30A shows an enlarged view of the front of the confirmation gauge 210 and holder 265. The dotted line in these views indicates the alignment of one of the receptacle areas 265A of the holder 265 with the AoCA marking 291A of the confirmation gauge 210. This receptacle area is designated 265A'. In this position, the holder 265 is locked, for example, by tightening the locking screw 265B, taking care to ensure that the aligners 266 / 266A on the outer shaft 261 simultaneously remain facing upward. Because the tubes cannot rotate relative to one another and the holder 265 is locked in place, the orientation of the catheter tube and holder 265 is fixed relative to one another based on the AoCA. The holder 265 is then held in its locked state. 5. The prosthetic valve is crimped using the loading system so that the loop / eyelet on the prosthetic valve frame 250, bearing the specific marking (aligned with one of the prosthetic valve's commissures), is aligned with the tab / paddle or receptacle 265A' on the holder 265, which is aligned with the AoCA marking 291A on the confirmation gauge 210. FIG. 31 shows the crimped valve 313 so aligned. For clarity, FIG. 31 shows only the valve frame, omitting the leaflets and other valve parts. An enlarged view is shown in FIG. 31A for further clarity. An exemplary specific marking 311 on the loop / eyelet 252', aligned with one of the valve's commissures, is also shown. FIG. 31B is a side view of the assembly shown. As shown in FIGS. 31 and 31B, the aligner 266 / 266A should always face upward. 31 and 31A show an exemplary embodiment having a confirmation gauge 210 marked with a clockwise angle 213B and receptacle areas 265A and 265A' for receiving loops / eyelets 252 and 252'. Component-specific numbers with an apostrophe refer to components with the particular feature. 265A refers to a receptacle area on the holder 265, while 265A' refers to one of the receptacle areas aligned with the AoCA marking 291A on the confirmation gauge 210. Similarly, 252 refers to a loop or eyelet on the prosthetic valve frame 250, while 252' refers to a loop / eyelet aligned with one of the commissure attachments 251 of the prosthetic valve frame 250. 6. The loops / eyelets 252 and 252' are engaged with the tabs / paddles or receptacle areas 265A and 265A' of the holder 265, as shown in FIG. 32 and the enlarged view in FIG. 32A. (a) The loops / eyelets of the frame 250, aligned with the commissures (with specific markings) 252' of the valve, engage the receptacle areas 265A' of the holder 265, aligned with the AoCA markings on the confirmation gauge 210, and (b) the aligner 266 / 266A or retainer sheath (if present) on the outer shaft 261 is facing upward. FIG. 32B shows a side view of the arrangement shown in FIG. 32. FIGS. 32 and 32A / 32B illustrate an exemplary embodiment of a delivery catheter in which the holder has receptacle areas. In this way, one of the commissures of the THV is aligned axially with the AoCA, and at the same time, the aligner faces upward, similar to what was described for the balloon-expandable THV. 7. The outer shaft 261 of the delivery catheter or the retainer sheath (if provided) is then moved over the crimped valve 313 and holder 265, holding the crimped valve 313 in this position in a radially contracted state. 8. The system is now ready to introduce the catheter into the patient's vasculature using the recommended introducer sheath.

[0107] The crimping procedure becomes slightly more complicated if any of the loops / eyelets 252 on the frame 250 are not axially aligned with any of the THV's commissures. In this case, the holder 265 is unlocked and rotated on the intermediate shaft 262 so that one of the holder's tab / paddle or receptacle areas 265A is oriented so that when the eyelets / loops 252 of the crimped THV are engaged with the holder's tab / paddle or receptacle 265A, one of the THV's commissures 251 aligns with the AoCA marking 291A on the confirmation gauge 210. The essential point is to align one of the THV's commissures with the AoCA, with the aligner 266 / 266A facing upward.

[0108] Placement (implant) method Using the crimping method described above, the self-expanding THV is attached to a delivery catheter and implanted to achieve commissure alignment. 1. Insert the distal end of the delivery catheter containing the prosthetic valve into the patient's vascular system through the introducer sheath with the Aligner 266 / 266A facing upward. It is effective to have the company logo facing upward if the Aligner is aligned with the axis of the company logo on the proximal handle. This orientation must not be changed during the placement procedure. Therefore, do not twist the delivery system. If unintentional twisting occurs during insertion of the THV system due to anatomical difficulties, the Aligner can help the surgeon reorient the system and release the torque. However, the system can be bent if it is equipped with a bending mechanism. 2. Navigate the delivery catheter through the patient's vasculature to the patient's aortic annulus. 3. As the prosthetic valve and balloon pass through the aortic annulus, one of the prosthetic valve's commissures is expected to orient toward its own commissure. The other commissures of the prosthetic valve will automatically align toward their own commissures. 4. Position the prosthetic valve at the desired target location for deployment. 5. The outer shaft or retainer sheath is withdrawn proximally to expose the crimped prosthetic valve and allow it to self-expand and deploy to the target location. The final placement with expected commissure alignment is shown in Figure 24.

[0109] Those skilled in the art will readily appreciate that this method is applicable to various types of bicuspid aortic valve anatomies, in which case the artisan will use the techniques described above to measure the AoCA angle to minimize commissure misalignment.

[0110] The present invention relies on three well-known facts: (a) fluoroscopic images are mirror images of anatomical / AP images, (b) a THV deployed under fluoroscopic guidance with only one commissure aligned toward the mirror image of the middle RCC according to fluoroscopic images (and MSCT, etc.) will actually be deployed anatomically toward the NCC-LCC commissure with minimal misalignment, and (c) a THV deployed under fluoroscopic guidance with only one commissure aligned toward the mirror image of the middle LCC according to fluoroscopic (and MSCT, etc.) observations will actually be deployed anatomically toward the RCC-NCC commissure with minimal misalignment.

[0111] Therefore, by using this procedure, it is possible to minimize the misalignment of the aortic valve commissures relative to the commissures of the prosthetic valve.

[0112] The scope of the present invention is limited only by the appended claims. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are exemplary only, and that the actual parameters, dimensions, materials, and / or configurations will vary depending on the particular application or uses for which the teachings of the present invention are used.

Claims

1. A method for crimping a prosthetic valve having at least two commissures onto a delivery system, comprising:

1. A method of crimping a prosthetic valve into a delivery system, the delivery system including one or more aligners marked on an outer shaft, the one or more aligners being aligned along the same axis, and the crimping of the prosthetic valve into the delivery system is performed using at least one of a crimper and a verification gauge including one or more angle markings on at least one surface, comprising: The method comprises: identifying an angle marking of the one or more angle markings on at least one of the crimper and the verification gauge, the angle marking representing a commissure alignment angle (AoCA) of the patient's native aortic valve; crimping the prosthetic valve onto the delivery system while axially aligning one of the commissures of the prosthetic valve with the angle marking corresponding to the commissure alignment angle (AoCA) of the patient's native aortic valve and simultaneously crimping the one or more aligners facing upward relative to the crimper or the verification gauge.

2. The method further comprises determining the commissure alignment angle (AoCA), determining the commissure alignment angle (AoCA) comprises: Step a. taking a cross-sectional image of the mid-sinus of Valsalva (Mid-SoV) using imaging software; Step b: drawing a horizontal centerline and a vertical centerline on an imaginary circle drawn by the image software on the cross-sectional image of the mid-Sinus of Valsalva (Mid-SoV), and identifying the intersection of the horizontal centerline and the vertical centerline as the geometric node of the sinus (GNS); Step c) drawing a line through the geometric node (GNS) of the sinus to the geometric midpoint of one of the right coronary cusp (RCC), left coronary cusp (LCC), and non-coronary cusp (NCC); 2. The method of claim 1, further comprising: step d. measuring the angle between the line drawn in step c. and the horizontal centerline extending to the right of the geometric node of the sinus (GNS) as the AoCA.

3. The method of claim 2 , wherein the imaging software is multislice computed tomography (MSCT) software.

4. the prosthetic valve is a balloon-expandable prosthetic aortic valve, and the step of identifying angle markings includes the step of identifying angle markings on the crimper, the one or more angle markings being in at least one of degrees and clockwise degrees, and the step of crimping the prosthetic valve includes: placing the crimper on a preparation table with the iris opening in an open position; placing the prosthetic valve at least partially across an iris opening of the crimper such that one of the commissures of the prosthetic valve aligns with an identified angle marking on the crimper corresponding to the commissure alignment angle (AoCA); positioning the balloon of the delivery system across the prosthetic valve held inside the iris opening of the crimper, with the one or more aligners facing upward; fully or partially crimping the prosthetic valve onto the balloon of the delivery system, maintaining the position of one of the prosthetic valve's commissures aligned throughout the crimping step with the one or more aligners facing upward and an identified angle marking on the crimper corresponding to the commissure alignment angle (AoCA); and opening an iris opening of the crimper and removing the balloon together with the fully or partially crimped prosthetic valve from the iris opening of the crimper.

5. The method of claim 4, wherein a line is marked on the angle marking of the crimper to identify the commissure alignment angle (AoCA) on the angle marking.

6. the step of partially crimping the prosthetic valve comprises: removing the balloon of the delivery system from the iris opening along with the partially crimped prosthetic valve; inserting the partially crimped prosthetic valve, along with a balloon of the delivery system, into a central opening of a confirmation gauge with the one or more aligners facing upward; determining whether any one of the commissures of the prosthetic valve is aligned with an angle marking on a verification gauge corresponding to the commissure alignment angle (AoCA); If misaligned, rotating the prosthetic valve on the balloon to adjust the position of the prosthetic valve so that one of the commissures of the prosthetic valve is aligned with an angle marking on a confirmation gauge corresponding to the commissure alignment angle (AoCA); removing the prosthetic valve, which is partially crimped onto the balloon of the delivery system, from the central opening of the confirmation gauge; inserting the prosthetic valve, partially crimped onto the balloon of the delivery system, into an iris opening of the crimper; and crimping the prosthetic valve completely and firmly onto the balloon of the delivery system.

7. the prosthetic valve is a self-expanding prosthetic valve with one of its commissures aligned with at least one loop or eyelet at one end of a frame of the prosthetic valve, and the step of identifying the angle markings includes identifying the angle markings on the confirmation gauge, the one or more angle markings being in at least one of degrees and clockwise degrees, and the step of crimping the prosthetic valve includes: locking a holder onto a delivery system intermediate shaft using a locking mechanism, the holder being positioned on the delivery system intermediate shaft, the holder having a plurality of tabs, paddles, or receptacle areas; inserting a distal end of the delivery system into a central opening of the confirmation gauge from one side thereof so that an outer shaft of the delivery system and a portion of a holder protrude from the other side of the confirmation gauge, the delivery system being oriented such that the one or more aligners are disposed up the outer shaft of the delivery catheter; unlocking the holder and rotating the holder on the intermediate shaft so that one of a tab, paddle, or receptacle area on the holder is aligned with a commissure alignment angle (AoCA) marking identified on the verification gauge; locking the holder at the distal end of the intermediate shaft; crimping the prosthetic valve into the inner lumen between the distal end of the holder and the proximal end of the tip using a loading system so that a loop or eyelet on the frame of the prosthetic valve aligned with one of the commissures of the prosthetic valve engages with a tab, paddle, or receptacle area of ​​the holder aligned with an angle marking identified on a verification gauge corresponding to a commissure alignment angle (AoCA); and moving an outer shaft or retainer sheath of the delivery system over the crimped prosthetic valve and the holder to hold the crimped prosthetic valve in a radially contracted state.

8. the prosthetic valve is a self-expanding prosthetic valve having at least one loop or eyelet at one end of a frame, and the step of identifying the angle marking includes the step of identifying the angle marking on the confirmation gauge; crimping the prosthetic valve locking a holder disposed on an intermediate shaft of a delivery system using a locking mechanism, the holder being provided with a plurality of tabs, paddles, or receptacle areas; inserting a distal end of the delivery system into a central opening of the confirmation gauge from one side thereof so that an outer shaft of the delivery system and a portion of a holder protrude from the other side of the confirmation gauge, and positioning the delivery system so that the one or more aligners face upward on the outer shaft of the delivery system; unlocking the holder and rotating the holder on the intermediate shaft so that one of the commissures of the prosthetic valve is aligned with the commissure alignment angle (AoCA) marking identified on the confirmation gauge when any one of the tabs, paddles, or receptacle areas on the holder engages with a corresponding eyelet or loop on the prosthetic valve; locking the holder at the distal end of the intermediate shaft; crimping the prosthetic valve into the inner lumen between the distal end of the holder and the proximal end of the tip such that at least one loop or eyelet on the frame of the prosthetic valve engages a tab, paddle, or receptacle area of ​​the holder that is aligned with an angle marking identified on a verification gauge to correspond to a commissure alignment angle (AoCA); and moving an outer shaft or retainer sheath of the delivery system over the crimped prosthetic valve and the holder to hold the crimped prosthetic valve in a radially contracted state.

Images