Confirmation meter

Description

1 / 34 CONFIRMATION METER (SPLIT FROM ORDER BR 11 2023 021799 7, DATED 05 / 20 / 2022) FIELD OF THE INVENTION

[001] The present invention relates to a system. More specifically, the present invention relates to a system and method for achieving minimal misalignment of the commissures of a transcatheter prosthetic heart valve with the commissures of a native heart valve. CONTEXT

[002] The function of a prosthetic heart valve is to replace a diseased native heart valve. The replacement procedure can be surgical (via open heart surgery) or percutaneous.

[003] In a surgical procedure, the leaflets (or cusps) of the diseased native heart valve are excised and the annulus is sculpted to receive a prosthetic heart valve. For many years, the definitive treatment for these disorders was surgical repair or replacement of the native heart valve during open-heart surgery, but these surgeries are subject to many complications. Some patients do not survive the surgical procedure due to trauma associated with the procedure and the duration of extracorporeal blood circulation. Because of this, several patients are considered inoperable and therefore remain untreated.

[004] In contrast to surgical procedures, a percutaneous catheterization technique has been developed for the introduction and implantation of a prosthetic heart valve using a flexible catheter, which is considerably less invasive than open-heart surgery. In this technique, a prosthetic valve is mounted by crimping onto a balloon located at the distal end of a flexible catheter, called a transcatheter heart valve (THV) system. The catheter is most commonly introduced into a blood vessel, usually through a peripheral artery (rarely through a vein); most likely a common femoral artery or sometimes the patient's axillary, carotid, or subclavian artery, or rarely via transapical (through the apex of the heart) or transcaval (through the vein and across to the aorta) access routes. The catheter with the prosthetic valve crimped onto the balloon is then advanced through the blood vessel until the crimped valve reaches the implantation site.The valve can expand to its functional size in place of the defective native valve by inflating the balloon in which the valve was mounted. Alternatively, the valve may have a stent. Petition 870260030784, dated 01 / 04 / 2026, page 8 / 73 2 / 34 self-expanding or a support structure that expands the valve to its functional size by removing a restraining sheath (retention sheath) mounted over the prosthetic valve. The first prosthetic valve is called a “balloon-expandable” valve and the second a “self-expanding” valve.

[005] Transcatheter aortic valve replacement (TAVR) has become a promising therapy in cases of severe and symptomatic aortic valve stenosis instead of surgical aortic valve replacement (SAVR).

[006] There is a very important unmet clinical need for a transcatheter heart valve (THV) system, namely commissural alignment, which includes aligning the commissures of a prosthetic heart valve with the commissures of the native aortic heart valve being treated. Commissural alignment (CA) of a THV is clinically important for several reasons described below. In real-world TAVR procedures, CA is not routinely performed as there is no simple method to achieve CA. Therefore, CA is an important unmet clinical need.

[007] The present invention aims to address the unmet need mentioned above. SUMMARY

[008] The present invention relates to a system and method for achieving commissural alignment (CA), that is, positioning a prosthetic heart valve (also referred to as THV) so that the commissures of the prosthetic heart valve are minimally misaligned with the commissures of a native heart valve in a novel and easy-to-use manner.

[009] The potential benefits of AC (commissural alignment) include (a) improved hemodynamic performance due to balanced flow dynamics within the neo-sinus, (b) reduced leaflet stress and increased long-term THV durability, (c) unrestricted access to the coronary ostia for future reinterventions (PCI), and (d) the ability to perform the Basilica procedure for future valve-in-valve interventions. The foregoing features and other features as well as the advantages of the invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.

[0010] The system and method for achieving commissural alignment (CA) is based on the following basic approach. Petition 870260030784, dated 01 / 04 / 2026, page 9 / 73 3 / 34 1. Determination of the Commissural Alignment Angle (AoCA). This angle depends solely on the anatomy of the patient's native aortic valve where the THV will be implanted. The method for determining the AoCA is described in detail below. 2. Crimp the THV onto the delivery system so that one of the THV's corners is axially aligned with the AoCA as determined in 1 above, with the aligner(s) facing upwards. The crimping method to achieve this orientation is described in detail below. 3. Implant the crimped THV as described in step 2 above, keeping the aligner(s) pointing upwards throughout the procedure. The implantation method is described in detail below. This basic approach is applicable to either an expandable balloon or a self-expanding THV as described in detail below. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] The above summary, as well as the following detailed description of illustrative embodiments, is best understood when read in conjunction with the accompanying figures. For the purpose of illustrating the present disclosure, exemplary constructions of the disclosure are shown in the figures. However, the disclosure is not limited to the specific methods and instruments disclosed herein. Furthermore, those familiar with the art will understand that the figures are not to scale. Wherever possible, similar elements have been indicated by identical numbers.

[0012] FIG. 1 is a schematic representation of the native aortic root.

[0013] Fig. 2 shows a schematic representation of the anatomical / AP view of the aortic root. It also shows the location where the AA cross-section of the Middle Sinuses of Valsalva (Mid-SoV) should be obtained.

[0014] Fig. 3 shows a cross-sectional multislice computed tomography (MSCT) scan of the middle sinuses of Valsalva in a short-axis perspective.

[0015] Figs. 3A illustrates an echo image of the TCMS image in Fig. 3.

[0016] Fig. 4 schematically illustrates the TCMS image of Fig. 3. Petition 870260030784, dated 01 / 04 / 2026, page 10 / 73 4 / 34

[0017] Figs. 5 to 10 Illustrate the method of determining the commissural alignment angle (AoCA) using TCMS images with software such as “3mensioTM”.

[0018] Figs. 11 to 14 (11A-D, 12A-D, 13A-B, 14A-B) illustrate the clock face superimposed with angular markings for various anatomies.

[0019] Fig. 15 shows a perspective view of the structure of a typical example of a balloon-expandable prosthetic valve.

[0020] Fig. 16 depicts a typical exemplary distribution system for a balloon-expandable THV.

[0021] Fig. 17 depicts the proximal end of the distribution system of Fig. 16 and the loop located at this end.

[0022] Fig. 18 depicts the distal end of the delivery system of Fig. 16 showing the inflatable balloon and the tip.

[0023] Figs. 19A-D depict a typical exemplary crimper with angular markings on its face for crimping a balloon-expandable THV onto a balloon of a delivery catheter.

[0024] Fig. 20 illustrates the crimper with the balloon-expandable prosthetic valve located within the iris opening of the crimper and the orientation of the balloon catheter as it is inserted into the iris opening.

[0025] Figs. 21A-D, 22A and 22B illustrate a confirmation meter in various views.

[0026] Figs. 23A and 23B Illustrate a method for confirming the correct positioning of the THV in the balloon of a delivery catheter before final crimping.

[0027] Fig. 24 depicts the ideal alignment of the commissures of a THV after implantation with the commissures of the native aortic valve using the system and method of this invention.

[0028] Fig. 25 shows an exemplary illustration of a typical self-expanding prosthetic heart valve.

[0029] Figs. 26 shows the distal portion of a typical distribution system of Fig. 27 for a self-expanding prosthetic valve.

[0030] Fig. 26A shows a cross-sectional view of the distal portion of the distribution system of Fig. 27. Petition 870260030784, dated 01 / 04 / 2026, page 11 / 73 5 / 34

[0031] Fig. 26B shows a perspective view of the distal portion of the distribution system of Fig. 27.

[0032] Fig. 27 shows the assembly of a typical delivery system for a self-expanding THV.

[0033] Fig. 28 shows the distal portion of the distribution system of Fig. 26 with continuous aligner marked on the outer stem.

[0034] Figs. 29A and 29B show a confirmation gauge of Figs. 21A-D, and 22A-B with AoCA marked on it. Fig. 29B shows the confirmation gauge of Figs. 21C and 21D with full angle markings.

[0035] Figures 30 and 30A depict how the distal end of the delivery catheter is introduced into the central opening of the confirmation gauge and the method of guiding the support.

[0036] Fig. 31, 31A / B, 32 and 32A / B illustrate a method for orienting a self-expanding THV when crimped into the inner lumen of the delivery catheter using the confirmation gauge.

[0037] The characteristics of the embodiments described are included in the claims. The embodiments and claims are best understood with reference to the following description and the figures accompanying the description. DETAILED DESCRIPTION OF THE ACCOMPANYING DRAWINGS

[0038] Before describing the invention in detail, the definitions of certain words or phrases used throughout this patent document will be defined: the terms include and comprise, as well as their derivatives, mean inclusion without limitation; the term or is inclusive, meaning and / or; the phrases coupled with and associated with it, as well as their derivatives, may mean include, be included within, interconnect with, contain, be contained within, connect to or with, couple to or with, be communicable with, cooperate with, intercalate, juxtapose, be near, be linked to or with, have a property or something similar; Definitions of certain words and phrases are provided throughout this patent document, and those skilled in the art will understand that such definitions apply in many, if not most, cases to prior and future uses of such defined words and phrases.

[0039] Reference throughout this descriptive report to “a modality,” “a modality,” or similar language means that a specific feature, structure, or characteristic described in connection with the modality is included in at least one modality. Thus, the Petition 870260030784, dated 01 / 04 / 2026, p. 12 / 73 6 / 34 appearances of phrases in a modality, in a modality and similar language throughout this descriptive report may, but do not necessarily, all refer to the same modality, but mean one or more, but not all, modalities, unless expressly specified otherwise. The terms “including,” “comprising,” “having,” and their variations mean “including, but not limited to,” unless expressly specified otherwise. An enumerated listing of items does not imply that any or all items are mutually exclusive and / or mutually inclusive, unless expressly specified otherwise. The terms “a,” “an,” and “the” also refer to “one or more,” unless expressly specified otherwise.

[0040] The description includes a number of exemplary embodiments which are provided for illustration of a general category of devices. It is understood that other alternative designs / variants of these exemplary embodiments are possible and are considered to be included in the description and scope of this invention.

[0041] Although exemplary embodiments of the disclosed method may be described in a specific sequential order for convenient presentation, it should be understood that the disclosed embodiments may encompass an order of operations different from the specific sequential order disclosed. For example, the operations described sequentially may, in some cases, be rearranged or performed simultaneously. Furthermore, the descriptions and disclosures provided in association with a specific embodiment are not limited to that embodiment and may be applied to any embodiment disclosed herein. Moreover, for the sake of simplicity, the accompanying figures may not show the various ways in which the disclosed system, method, and device may be used in combination with other systems, methods, and devices.

[0042] Furthermore, the described features, advantages, and characteristics of the modalities can be combined in any suitable manner. Someone skilled in the relevant art will recognize that the modalities can be practiced without one or more of the specific features or advantages of a particular modality. In other cases, additional features and advantages may be recognized in certain modalities that may not be present in all modalities. These features and advantages of the modalities will become more fully apparent from the following description and distributed claims, or can be learned by practicing the modalities as set forth below. Petition 870260030784, dated 01 / 04 / 2026, page 13 / 73 7 / 34

[0043] It should be noted that terms such as 'prosthetic aortic valve', 'prosthetic valve', 'prosthetic heart valve' and 'transcatheter heart valve' (THV) correspond to the same implantation device and are therefore referred to interchangeably throughout the description.

[0044] In the description of the system and methods, “proximal” will mean the direction to the operator performing the procedure and “distal” will mean the direction away from the operator.

[0045] The present invention describes a commissural alignment system for a transcatheter heart valve when used to replace a diseased native aortic valve. The system and method described herein can be used for a balloon-expandable valve as well as for a self-expanding prosthetic valve, using the same basic procedure described below. • Determine the Commissural Alignment Angle (AoCA). • Crimping the prosthetic valve onto the distribution catheter using a crimping tool; using AoCA, the aligners marked on the external stem of the catheter, angular markings on the crimping tool / confirmation gauge, and one of the corners of the prosthetic valve as guides. • Implant the prosthetic valve at the target site, taking care to ensure that the aligner(s) marked on the outer stem of the delivery catheter point upwards throughout the implantation procedure. Although the system and method are described separately for balloon-expandable and self-expanding prosthetic valves for clarity, a specialist would readily recognize that the basic principles used for both types of prosthetic valves are identical.

[0046] The commissural alignment system of the present invention can be used to implant a balloon-expandable prosthetic aortic valve or a self-expanding prosthetic aortic valve (a transcatheter heart valve, THV) into a patient's body to achieve minimal misalignment of the commissures of the prosthetic aortic valve with the commissures of the native aortic valve. The present invention achieves commissural alignment by introducing novel modifications to a delivery system and a crimping device that are easy to incorporate. A specialist would immediately appreciate that these modifications do not affect the basic design and construction characteristics of the delivery system and the crimping system. As Petition 870260030784, dated 01 / 04 / 2026, page 14 / 73 8 / 34 would be obvious, the modifications are very similar for balloon-expandable systems, as well as for self-expanding THVs.

[0047] Furthermore, the present invention describes a crimping method based on the above modifications that is easy for the user to follow and also assists in the near-perfect alignment of the commissures of a prosthetic heart valve with the native aortic valve.

[0048] The description below is divided into three sections as follows for convenience and better understanding of the system and method. • Determination of AoCA based on the anatomy of the patient's aortic root. • System and method for balloon-expandable prosthetic valve. • System and method for a self-expanding prosthetic valve. AoCA Determination

[0049] In the anatomy of the native tricuspid aortic valve, the three commissures are located 120° from each other. For true Type 0 bicuspid anatomy, these commissures are located 180° from each other. Normally, there are three coronary cusps at the root of the aorta. Ideally, the coronary arteries originate from the coronary cusps.

[0050] The aortic root complex (ARC) is shown schematically in Fig. 1. The aortic root complex is the first part of the aorta connected to the heart towards the left ventricular outflow tract (LVOT). It is a part of the ascending aorta (AA) that contains the native aortic valve and other anatomical structures such as the sinuses of Valsalva (SoV), sinotubular junction (SJ), and coronary arteries. Normally, there are three cusps of the native aortic valve. The coronary arteries originate near the bulb of the aortic sinus from two of the three cusps. The Right Coronary Artery (RCA) ideally originates from the Right Coronary Cusp (RCC), and the Left Coronary Artery (LCA) ideally originates from the Left Coronary Cusp (LCC). The remaining cusp is called the Non-Coronary Cusp (NCC), since no coronary artery originates in the vicinity of this cusp.Typically, all three coronary cusps are in different planes, with the CNC residing below the CCD or CCE. In a two-dimensional view, there are two distinct transverse demarcation planes. The first plane, at the origin of the aortic root, is called the Virtual Annular Plane (VAP), and the second plane, at the origin of the ascending aorta, is called the Sinotubular Junction (SJ). In a standard TAVR / TAVI procedure performed under fluoroscopic guidance, the native coronary cusps are... Petition 870260030784, dated 01 / 04 / 2026, page 15 / 73 9 / 34 coplanar where the articulation point of each cusp is in a straight line and all three cusps are well separated without any parallax. The VAP thus obtained can be visible under fluoroscopy (usually by placing a standard 5Fr pigtail catheter in the CNC during the aortogram) and is a guiding feature for positioning the prosthetic valve in the ideal location for implantation. Fig. 1 depicts the aortic root with all three cusps aligned along the virtual annular plane (VAP), along with the sinotubular junction (SJ) and the coronary arteries originating from the cusps.

[0051] Fig. 2 schematically shows the anatomical / AP (APV) view of the aortic root of Fig. 1. It also shows the location where the AA cross-section of the Middle Sinuses of Valsalva (midSoV) should be taken to determine the AoCA.

[0052] Fig. 3 shows the fluoroscopy image using multislice computed tomography (MSCT) in the AA cross-section of the middle sinuses of Valsalva (see Fig. 2) in a short-axis perspective. Fig. 3A presents the Echo image of what is seen in Fig. 3. A virtual circle (VC) is drawn by the software around the fluoroscopy image, as shown in Fig. 3.

[0053] Fig. 4 shows the image of Fig. 3 schematically for clarity. Fig. 4 shows three cusps viz. CCD, CCE and CNC with coronary arteries ACD and LCA originating from CCD and CCE shown as short projections. No artery originates from CNC. There are three commissures of the native aortic valve designated as RL commissure (RLC), LN commissure (LNC) and NR commissure (NRC). The virtual circle (VC) drawn by the software is also shown.

[0054] It may be noted that the fluoroscopic view, as observed in multislice computed tomography (MSCT) or any other equivalent imaging system, is a mirror image of the true anatomical / AP view. This fact is known to the surgeon performing the procedure.

[0055] This invention describes a novel method for achieving the positioning of the prosthetic valve so that the commissures of the prosthetic valve are minimally misaligned with those of the native aortic valve. The method can be easily followed by the user. Alignment is achieved by aligning any of the three commissures of the THV, preferably with the middle sinus of the CCD, as seen in a cross-sectional image derived from CT scan or an equivalent imaging system. Alternatively, alignment can also be achieved by aligning any of the three commissures of the THV with the sinus. Petition 870260030784, dated 01 / 04 / 2026, page 16 / 73 10 / 34 average of the CCE or CNC. The method of this invention can be used for an expandable balloon as well as for a self-expanding THV.

[0056] This invention also discloses additional new features that can be easily incorporated into the delivery and crimping systems, as well as the implantation method which is easy to follow to achieve the positioning of the prosthetic valve so that the commissures of the prosthetic valve are minimally misaligned with those of the native aortic valve. One method for determining the AoCA:

[0057] To begin, the “Commissural Angle Alignment” (AoCA) is determined by examining the anatomy of a patient’s aortic root housing the native aortic valve. This is done using the technique described as a step-by-step procedure further below. The following procedure is described with respect to the middle sinus of the CCD as a reference point. However, the middle sinus of the CCE or CNC can also be used as a reference point. AoCA plays a fundamental role in achieving commissural alignment.

[0058] To explain the AoCA determination technique, TCMS images are used. However, any other similar imaging system can be used in place of TCMS. For greater clarity, schematic drawings of the SoV are also shown in addition to or in place of the TCMS cross-section. • Step 1: Capture the cross-sectional image of the middle sinuses of Valsalve (SoV) using TCMS imaging software, such as “3mensio™” or any other equivalent software. Figure 3 shows the fluoroscopy image captured by said software, along with an echo image in Figure 3A. The fluoroscopy image from Fig. 3 is shown schematically in Fig. 4 for clarity. As shown in Figs. 3 and 4, a virtual circle (VC) is drawn by the software around the TCMS cross-sectional image of the SoV. • Step 2: Draw horizontal and vertical center lines (HCL and VCL respectively) on the virtual circle (VC) drawn by the software in the image of Fig. 3 as shown in Fig. 5 and schematically in Fig. 6. The intersection of these center lines is called Petition 870260030784, dated 01 / 04 / 2026, page 17 / 73 11 / 34 “geometric sinus nodule” (GNS). In addition, Fig. 6 shows the ACD and ACE originating from their respective cusps as short projections. • Step 3: Draw a line (L) through the geometric sinus node (GNS) to the geometric midpoint of the CCD (70), as shown in the diagram in Fig. 7. The angle formed between this line and the horizontal centerline (HCL) extending on the right side of the GNS is called the “Commissural Alignment Angle (AoCA)”. The geometric midpoint of the CCE is shown as 71. • Step 4: Overlay the face (110) with marked angles onto the cross-sectional image, for example from Fig. 7 as shown in the schematic drawing of Fig. 11A where the angles in the angle markings are expressed as degrees. In this example figure, the AoCA is around 71 degrees. In another example embodiment of Fig. 11B, the angular markings are expressed in a more convenient way in the form of a clock (111) on the cross-sectional image, for example, from Fig. 7. In this case, the AoCA is identified as a “Clock Angle” which can be expressed as, for example, 3:03 hours in Fig. 11B. • The angle markings shown in Figs. 11A and 11B cover half the circumference of the virtual circle (VC) drawn by the software. If necessary, the angle markings (112 and 113) can cover the entire circumference of the virtual circle (VC) drawn by the software as shown in Figs. 11C and 11D. Fig. 11C shows angle markings expressed in degrees, while Fig. 11D shows angle markings expressed as a clock angle.

[0059] Fig. 7 shows one of the cases where the Right Coronary Artery (RCA) originates from the geometric midpoint of the RCC (70) and the Left Coronary Artery (LCA) also originates from the geometric midpoint of the LCC (71). In other cases, the RCA may originate off-center, as shown schematically in Fig. 8, where the geometric midpoint of the RCC is shown as 80. Also in this case, the AoCA is still the angle formed between a line drawn from the GNS through the geometric midpoint of the RCC (80) and the horizontal centerline extending on the right side of the GNS, as shown in Fig. 8. Other examples of anatomies are shown in Figs. Figures 9 and 10. In Fig. 9, the ACE originates off-center from the geometric midpoint (90) of the CCE), and in Fig. 10, both the ACD and the CCE originate off-center from the geometric midpoints of the CCD (100) and CCE (101), respectively. There would be other variations. Petition 870260030784, dated 01 / 04 / 2026, p. 18 / 73 12 / 34 possible anatomical variations. In all these cases, the AoCA is still the angle formed between a line (L) drawn from the GNS through the geometric midpoint of the CCD and the horizontal centerline extending from the GNS on the right side, regardless of where the coronary arteries originate. Therefore, this procedure would work effectively in the case of such anatomical differences.

[0060] In all the modalities described above, the AoCA is measured between the L line and the horizontal centerline (HCL) extending on the right side of the GNS. However, the AoCA can also be measured between the L line and the horizontal centerline extending on the left side of the GNS. Similarly, the AoCA can also be measured between the L line and the vertical centerline extending upwards or downwards from the GNS. The main point is to measure the AoCA. In these cases, the reference point will change. In the following description, the AoCA is measured between the L line and the horizontal centerline on the right side of the GNS. An expert will easily understand how the method can be used with other reference points.

[0061] Two alternative units of measurement and expression of AoCA are described above, namely the angle in degrees and as a clock angle. A specialist would appreciate that any other unit of measurement and expression of this angle (i.e., AoCA) is equally effective and can be used. The clock angle is a convenient way to measure and express the angle. The meaning of AoCA would become clear from the crimping description that follows.

[0062] Anatomy is patient-specific, and therefore each patient would have a different anatomy. Therefore, it is necessary to determine the AoCA of the patient under treatment. Figures 12A, 13A, and 14A show examples of some anatomical variants of the average CCD corresponding to angles in degrees. Figures 12B, 13B, and 14B show examples of the anatomical variants shown in Figs. 12A, 13A, and 14A corresponding respectively to clock angles. In these exemplary images, the AoCA is measured between the L line and the horizontal centerline (HCL) that extends on the right side of the GNS. These images are illustrative and show one of the cases in which the Right Coronary Artery (RCA) originates from the geometric midpoint of the CCD and the Left Coronary Artery (LCA) originates from the geometric midpoint of the CCE. In other cases, as described above, ACD and ACE may originate from decentralized sources, as mentioned above.Furthermore, any other unit of measurement and expression of the angle is equally effective. The AoCA in the case of Fig. 12A, for example, can be expressed as 90°. While in the exemplary cases of Fig. 13A and Fig. 14A, it can be expressed as 60° and... Petition 870260030784, dated 01 / 04 / 2026, p. 19 / 73 13 / 34 120°, respectively. The AoCA in the case of Fig. 12B, for example, can be expressed as 3:00 hours. While in the exemplary cases of Fig. 13B and Fig. 14B, it can be expressed as 3:05 and 2:55 hours, respectively.

[0063] Figs. 12C and 12D show the angle markings covering the entire VC in degrees and clock angles, respectively, for illustration.

[0064] The description above refers to a specific situation where the AoCA is determined relative to the geometric midpoint of the CCD. An expert would understand that the AoCA can also be determined from the geometric midpoint of the CCE or CNC. It can be noted that the AoCA in these cases would be different from that measured relative to the geometric midpoint of the CCD. The reference will then change to CCE or CNC.

[0065] The specialist will readily understand that this method is also applicable to different types of bicuspid aortic valve anatomy. The AoCA will be determined in a similar manner.

[0066] As would be clear to a specialist, the method for determining AoCA does not depend on whether the HRT to be implanted is balloon-expandable or self-expanding because AoCA depends entirely on the anatomy of the patient being treated. Therefore, the method for determining AoCA is applicable to both types of HRTs. Furthermore, the goal is to measure AoCA with any specific reference point mentioned above. Method for commissure alignment for a balloon-expandable THV. Balloon-extendable THV

[0067] A person skilled in the art is well aware of the different designs of a balloon-expandable prosthetic valve consisting, among other components, of a radially foldable and expandable frame. The frame is a scaffolding structure, preferably tubular in shape, generally formed by multiple rows of circumferentially extending struts that may be interconnected directly or by struts extending in the general axial direction. The scaffolding structure formed by the struts forms multiple rows of cells. Several balloon-expandable prosthetic valves are commercially available and described in the literature with different scaffolding designs. The designs continue to be refined and optimized. A person skilled in the art will readily understand that this invention can be used for the structure of any scaffolding design. For illustration, a structure Petition 870260030784, dated 01 / 04 / 2026, page 20 / 73 14 / 34 A typical example of a balloon-expandable THV is shown in Fig. 15. As shown in Fig. 15, the exemplary structure 150 of a balloon-expandable prosthetic valve has rows of supports 151 that extend circumferentially, joined by struts 152 generally oriented vertically. These struts form rows of cells 153. In addition, there are commissure attachment areas 154 where commissure portions of the leaflets are attached. It is understood that Fig. 15 shows only an illustration of a structure 150 of a balloon-expandable THV.

[0068] The balloon-expandable THV is further provided with at least two leaflets, preferably three leaflets made of animal tissue or synthetic materials. The commissure portions of two adjacent leaflets are attached to the commissure attachment areas 154 of the framework 150 to form commissures of the prosthetic valve. The framework 150 may be made of metallic or polymeric materials.

[0069] The balloon-expandable prosthetic aortic valve may also include at least one inner skirt and one outer skirt. The inner skirt covers the inner surface of structure 150, at least partially. The outer skirt covers the outer surface of structure 150, at least partially.

[0070] An expert will readily understand that this invention can be used for a balloon-expandable prosthetic valve of any design. Balloon-expandable THV administration system:

[0071] As mentioned earlier, to achieve Commissural Alignment, additional features are required to be provided in the delivery system. This section describes these additional features for a delivery system for a balloon-expandable THV, i.e., a balloon catheter.

[0072] A specialist is well aware of the construction of a balloon catheter used to radially expand a balloon-expandable device, such as a stent or a prosthetic valve. An example of a balloon catheter 160 is shown in Fig. 16. It has a proximal end 170 and a distal end 180, an elongated outer tube 161 (also referred to as the outer shaft) through which extends an inner tube (also referred to as the inner lumen, not shown) coaxially with the outer tube. Both tubes are collectively called “tubes”. The tubes have respective distal and proximal ends. Petition 870260030784, dated 01 / 04 / 2026, page 21 / 73 15 / 34

[0073] The proximal ends of the tubes pass through a loop 162 and are fixed to a Y-connector 163 which has an exit port for guidewire 163A and an inflation fluid injection port 163B. The guidewire port is in communication with the inner lumen and the inflation fluid port is in communication with the annular space between the two tubes.

[0074] Balloon 164 is connected to the distal end of the outer stem 161. The inner lumen extends through balloon 164 and terminates in a soft tip 165 at the most distal end of the catheter. The guidewire enters the lumen of the guidewire at the distal soft tip 165 of the catheter, enters the inner lumen that passes through balloon 164 and exits at the Y-connector 163. As stated previously, 'proximal' means towards the operator, while 'distal' means away from the operator.

[0075] Balloon 164 is expanded radially by injecting pressurized inflation fluid into balloon 164 through the annular space between the outer rod 161 and the inner lumen.

[0076] The above description discloses details of a 160 balloon catheter according to an exemplary embodiment. It should be noted that there may be other balloon catheter designs that are considered to be covered by this invention.

[0077] The present invention involves new modifications that can be easily made to a balloon catheter, as described below, and assist in commissural alignment.

[0078] The outer shaft 161 of the distribution system is provided with one or more markings called aligners 166. The embodiment of Fig. 16 shows multiple aligners 166, spaced from each other, preferably equidistant from each other in a single orientation, i.e., on the same axis. The subsequent discussion refers to the plurality of aligners for convenience. Meanwhile, it is understood that it also includes a single aligner. As the aligners 166 are provided on the outer shaft 161 of the distribution system 160, they are visible as such. To improve overall visibility, the color of the aligners 166 should contrast with the color of the outer shaft 161. The aligners would also be visible under fluoroscopy if they were made of radiopaque material. The aligners can be painted onto the outer shaft 161 or strips of biocompatible material can be glued to the outer shaft 161.If the ink is radiopaque or the strips are made of radiopaque material, the aligners will also be visible under fluoroscopy. Alternatively, the aligners can be delivered to the outer stem 161 using a laser beam. Any other method of applying the aligners is equally effective. The aligners must be biocompatible. Petition 870260030784, dated 01 / 04 / 2026, p. 22 / 73 16 / 34

[0079] The preferred embodiment of the delivery system of this invention, which has a working length of 120 cm, is provided with four aligners 166, each of equal length and evenly spaced from each other. Alternatively, the number of aligners may be greater or less than four and the spacing between them may be non-uniform. Alternatively, there may be a single aligner provided as a continuous line extending from the proximal handle to the distal end of the outer rod. The color of the outer rod 161, for example, in the preferred configuration is orange. Thus, the color of the aligners 166 may be white. The color of the outer rod of the application system in contrast to the color of the aligner(s) provides better visibility to the aligners. The aligners of the preferred embodiment are made of biocompatible white strips that may preferably be radiopaque.The strips can be attached to the outer rod 161 using known techniques such as gluing. Alternatively, the white aligners can be painted onto the orange outer rod 161.

[0080] Because the 166 aligners are supplied on a single axis, they help maintain specific orientation during the introduction of the distribution system for commissural alignment. The 166 aligners assist in preventing any inadvertent twisting of the distribution system during insertion and in further tracking the system through the aortic anatomy.

[0081] For example, in the preferred embodiment, there are multiple aligners 166 marked on the same axis as the company logo 167 (or any other equivalent reference) on the proximal handle, as shown in Fig. 16. This is a convenient way to identify the axis of the aligners 166. Alternatively, as mentioned earlier, there may be a single aligner along its entire length.

[0082] Fig. 16 shows a distribution system where a distal section of the 168 stem can be flexed to follow the shape of the aortic arch. Note that this is just one example and the distribution system may have a non-flexible stem option.

[0083] The aligners 166 begin at the proximal loop 162 (also referred to as the most proximal aligner) with reference to an axis and terminate at the distal end of the outer stem 161 (i.e., most distal aligner) or at the proximal edge of the balloon 164 maintaining the same axis. Fig. 17 shows the preferred embodiment of the proximal end 170 of the balloon catheter 160. In this preferred embodiment, the aligners 166 follow the same axis as the company logo 167 Petition 870260030784, dated 01 / 04 / 2026, page 23 / 73 17 / 34 on the proximal loop 162 and continue on the same axis (i.e., maintain the same orientation) to the proximal edge of the balloon 164 or distal end 180 of the outer rod 161 as shown in Fig. 18, which shows the distal end 180 of the balloon catheter 160. This is merely a convenient way to mark the aligners 166. It is not necessary to follow the same axis as the company logo. Alternatively, there may be a single aligner starting at the proximal loop with reference to an axis and ending at the proximal edge of the balloon 164.

[0084] An expert would acknowledge that the marking of the 166 aligners on the outer stem, as stated above, is new and does not affect the design parameters or performance of the delivery catheter. Crimper:

[0085] As mentioned earlier, to achieve commissural alignment, additional features are required in the crimper. This section describes these additional features for a crimper.

[0086] 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 which are arranged within a housing 192 so that they form a nearly circular iris aperture 191A. Typical crimpers consist of at least six jaws; normally twelve jaws. However, the crimper may have any number of jaws, six or more than six. The housing 192 houses a mechanism for moving these jaws in a synchronous manner, whereby the diameter of the iris aperture 191A formed by the jaws can be varied or adjusted and generally remains circular in shape (i.e., a regular polygon). The mechanism is operated by a handle 192A. Moving the handle 192A activates the mechanism. Initially, the handle is in a position (usually upwards) where the diameter of the iris aperture 191A is at its maximum.The prosthetic valve, which is at least in a partially expanded configuration, is positioned over the deflated balloon of the delivery catheter and is introduced into the opening of the open iris 191A, which is large enough to accommodate the balloon and the prosthetic valve. The handle is moved (usually downwards) to activate the mechanism that moves the jaws 191 so that the diameter of the iris opening 191A formed by them gradually reduces. A. Petition 870260030784, dated 01 / 04 / 2026, page 24 / 73 The 18 / 34 reduction in aperture diameter causes the diameter of the prosthetic valve structure to collapse radially to achieve crimping of the valve onto the balloon.

[0087] The crimper described above is exemplary. The procedure described here is applicable to other types of crimpers that operate on similar operating principles.

[0088] A specialist is well-versed in the crimping procedure and crimpers of different designs. Conventionally, no attention is paid to the orientation of the prosthetic valve commissures during the crimping of the prosthetic valve onto the balloon. Therefore, there is no conscious effort to achieve commissural alignment. New modifications described below can be easily made to a conventional crimper to achieve commissural alignment. A specialist would readily understand that such modifications do not affect the basic design or functioning of the crimper.

[0089] In the present invention, a conventional crimper can be provided with angle markings 193 on at least one of its external surfaces around a central opening 194 of the crimper, as shown in Fig. 19A, where these markings 193 are expressed in degrees. These angle markings 193 must correspond to the angle markings in the cross-sectional image of average SoV in Fig. 11A, 12A, 13A or 14A.

[0090] Alternatively, the 193 angle markings can be expressed as clock angles, as shown in embodiment 190A of Fig. 19B, corresponding to the 193 angle markings shown in Fig. 11B, 12B, 13B or 14B.

[0091] In the embodiments described above, the angle markings 193 cover half the circumference of the central opening 194 of the crimper. The angle markings 193 can be provided to 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 they are expressed as clock angles in Fig. 19D. It is understood that these angle markings correspond to the angle markings in the cross-sectional image of the average SoV (Figs. 11A-D, 12A-D, 13A / B, 14A / B).

[0092] As mentioned earlier, any other way of measuring and expressing angles is equally effective and the same can be followed to mark the outer surface of a crimper. However, the angular markings 193 on the crimper must correspond to the angular markings in the cross-sectional image of mean SoV. Petition 870260030784, dated 01 / 04 / 2026, p. 25 / 73 19 / 34

[0093] Angle markings can be provided on either side of the crimper for the convenience of left- or right-handed users. Procedure for achieving commissural alignment.

[0094] Using the AoCA determined by the method above, the aligners 166 in the application system described above, and the angular markings 193 provided on the crimper, a surgeon can achieve commissural alignment in a manner that is easy to follow, as described in the procedure below. This procedure mentions the clock angle as the basis for achieving commissural alignment, as it is very convenient to use. However, a specialist will understand that measuring and expressing the AoCA in degrees or in any other way is equally effective and can be used for the procedure and to fall within the scope of this invention. It is understood that the following procedure is performed under aseptic conditions.

[0095] The procedure described is for a three-leaflet valve with three commissures positioned 120° apart. However, this procedure is applicable to a bicuspid valve with two commissures or any other anatomical variation according to the Sievers classification of bicuspid aortic valves.

[0096] The step-by-step procedure is as follows. 1. Determine the patient's AoCA using the procedure described above and calculate the corresponding clock angle. 2. Place the crimper with angled markings 193 expressed as clock angles on the preparation table and open the iris opening 191A by rotating the crimper handle. 3. As shown in Fig. 20, place the crimp-ready prosthetic valve 201 at least partially through the iris opening 191A of the crimper so that either of the commissures of the prosthetic valve is aligned with the AoCA (determined in step 1). To maintain the prosthetic valve 201 in this position, the diameter of the iris opening 191A can be reduced by operating 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. Place balloon 164 of the delivery system in the deflated condition, at least partially, through the prosthetic valve (which is held within the iris opening of the Petition 870260030784, dated 01 / 04 / 2026, page 26 / 73 20 / 34 crimper) so that the distal edge aligner 166 faces upwards as shown in Fig. 20. Aligners 166 should always be facing upwards, regardless of the AoCA. If aligners 166 are not available, the system can be held with the proximal handle 162 and the company logo 167 facing upwards. Optionally, a device can be provided to hold the catheter stem in position until the crimping operation is complete to ensure the aligner is always facing upwards. A specialist can design this device. 5. Crimp the prosthetic valve onto the balloon of the delivery system, keeping one of the prosthetic valve's corners aligned with the angle of the clock corresponding to the AoCA and the aligner on the external catheter stem facing upwards, as detailed above. 6. Before completing the crimping of the THV, it may be advisable to check the orientation of the prosthetic valve and catheter stem. At this stage, the prosthetic valve should be crimped to a point where it is free enough to rotate around the catheter balloon to make minor adjustments, if necessary. A confirmation gauge can be used for this purpose. Figs. 21A-D show four alternative configurations of an exemplary confirmation gauge 210. A preferred configuration of a confirmation gauge 210 is a square-shaped block 211 with a central opening 212 large enough to insert the partially crimped valve together with the balloon. As shown in Fig. 21A, angle markings 213A are provided around the central opening 212. These angle markings 213A correspond to the angle markings 110 in the software images (e.g., 11A, 12A, 13A, 14A) as well as the angle markings 193 provided on the crimper (e.g., Fig. 19A). The angle markings 213A are made on at least one side (e.g., side A) of the block from where the crimped THV is inserted into the central opening. Optionally, angle markings 213A may be provided on both sides (side A as well as side B) of the exemplary confirmation gauge 210, taking care that they correspond exactly to each other.The preferred configuration of the exemplary confirmation meter 210 shown in Fig. 21A has angle markings 213A in degrees. The embodiment of Fig. 21B has markings. Petition 870260030784, dated 01 / 04 / 2026, p. 27 / 73 21 / 34 angle 213B in clock angles. In both of these modes, the angle markings 213A and 213B cover half the circumference of the central opening 212. However, as mentioned earlier, any other method of angle marking is equally effective. Alternative modes shown in Figs. 21C and 21D, the angular markings 213C and 213D, respectively, cover the entire circumference of the central opening 212. The angle markings are expressed in degrees (213C) in Fig. 21C and as clock angles (213D) in Fig. 21D. In any case, the angular markings on the confirmation gauge must correspond to the angular markings 193 on the crimper. A side view and a cross-sectional view of the exemplary confirmation gauge 210 of Fig. 21A and Fig. 21B are shown in Fig. 22A and 22B, respectively. The cross-sectional views and side views of the embodiments of Figs. 21C and 21D would be similar with angular markings covering the entire circumference of the central opening 212. The confirmation gauge can be made of any suitable material, such as metal or polymer. The preferred configuration of the confirmation gauge is square. However, the shape can be rectangular, circular, or any other shape. The partially crimped THV (232) along with the catheter balloon (164) is removed from the iris opening 191A of the crimper and inserted into the central opening 212 of the confirmation gauge 210 with the distal edge aligner facing upwards, as shown in Figs. 23A and 23B. For illustration, the angle markings 213B on face A of the confirmation gauge are expressed as clock angles covering half the circumference of the central opening 212. The location of any of the commissure areas of the THV 232 must be aligned with the angle marking 213B corresponding to the AoCA (clock angle in this exemplary embodiment). Otherwise, adjustment can be made to the orientation of the THV 232 to correct the orientation so that one of the commissure areas of the THV 232 aligns with the angle marking 213B corresponding to the AoCA. Balloon 164, along with the partially crimped THV 232, are then removed from the confirmation gauge.The THV 232 is then completely and firmly crimped onto balloon 164 using the crimper. 7. After the THV is fully crimped, open the iris opening 191A of the crimper by operating handle 192A. Remove balloon 164 containing the crimped prosthetic valve from the iris opening of the Petition 870260030784, dated 01 / 04 / 2026, page 28 / 73 22 / 34 crimper. The system is now ready to introduce the catheter into the patient's vasculature (usually via the femoral artery) through the recommended introducer sheath. Other routes mentioned previously can also be used. 8. Insert the distal end of the catheter with the prosthetic valve crimped onto the balloon into the patient's vasculature through an introducer sheath, keeping the aligner(s) 166 facing upwards. If aligners are not present, the system may be held with the proximal handle and the company logo facing upwards. This orientation of the aligner(s) 166 should not be altered during the implantation procedure. Therefore, the operator is required not to tighten the delivery system. The aligner(s) 166 actually help the operator to untorque the delivery system in case of inadvertent torque due to anatomical challenges. However, the system can be flexed if it has a flexion mechanism. 9. Once the prosthetic valve and balloon have passed through the aortic annulus, one of the commissures of the prosthetic valve is expected to align towards a native commissure. The other commissures of the prosthetic valve would automatically align with the other native commissures. The prosthetic valve is then implanted using standard techniques. The expected final implantation with commissural alignment is shown in Fig. 24 under ideal conditions. Fig. 24 shows one of the cases where the commissures of the prosthetic valve are aligned with the native NCC-LCC commissures using the mid-CCR technique. Practically, there would be minimal misalignment. The specialist will easily understand that this method is also applicable to different types of bicuspid aortic valve anatomy. Method for commissure alignment for a self-expanding THV.

[0097] A specialist is aware that a self-expanding prosthetic valve is different from a balloon-expandable prosthetic valve. The delivery system for a self-expanding prosthetic valve is different from that of 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 commissure alignment for a self-expanding prosthetic valve remain similar to those for a balloon-expandable prosthetic valve described previously. New additional features that can be easily incorporated are provided in the delivery system and in the Petition 870260030784, dated 01 / 04 / 2026, page 29 / 73 23 / 34 crimping method to achieve the goal of commissural alignment for self-expanding prosthetic valve. Self-expanding prosthetic valve:

[0098] A self-expanding prosthetic valve consists of a structure, generally tubular in shape (but may have different diameters along its axial length), made of a shape-memory alloy, such as nickel-titanium alloy, for example, nitinol, or a polymer with shape-memory properties. Several self-expanding prosthetic valves are commercially available or described in the literature with different scaffold designs. The designs continue to be refined and optimized. A specialist will readily understand that this invention can be used for the structure of any scaffold design. A typical exemplary structure 250 of a self-expanding prosthetic valve is shown in Fig. 25. The frame has commissure attachment areas where commissure portions of the two adjacent leaflets are attached. One such commissure attachment area (251) is shown in Fig. 25.Due to the shape memory imparted to the structure, the structure can self-expand from a radially collapsed state typically achieved at lower temperatures (usually in an ice bath), where the metallic material is in the martensite phase, to a predefined diameter when the restraining force applied to collapse the valve is removed while the valve is exposed to a higher temperature found in the bloodstream where the metal of the structure transforms into the austenite phase.

[0099] The self-expanding THV is further provided with at least two leaflets (not shown), preferably three leaflets made of animal tissue or synthetic materials. The commissure portions of two adjacent leaflets are attached to the frame 250 at the commissure attachment areas 251 of the frame 250 to form valve commissures.

[00100] In addition, the prosthetic valve may be supplied with at least one inner skirt and one outer skirt as described for the balloon-expandable prosthetic valve (not shown).

[00101] At least one, preferably at least two, eyelets, loops or retainers (252) are provided at the exit end A of the structure 250 to capture tabs or paddles or to fit into receptacles provided in the delivery system for anchoring the prosthetic valve to the catheter (described below). Petition 870260030784, dated 01 / 04 / 2026, page 30 / 73 24 / 34

[00102] A specialist in the technique is well acquainted with the different designs of the self-expanding prosthetic valve. Structure 250 shown in Fig. 25 is illustrative.

[00103] As shown in Fig. 25, the exemplary self-expanding THV frame 250 has a tubular shape. The frame 250 includes a proximal end, a distal end, and a shaft that passes through the proximal and distal ends. The frame of the embodiment shown in Fig. 25 has varying diameters along its axial length. However, the frame may have other shapes, such as an hourglass shape, a tubular shape of uniform diameter, etc. One of the commissure attachment areas 251 of the frame 250 is also shown in Fig. 25.

[00104] There are two loops (252) provided at the outlet end of the structure in the exemplary embodiment of the aortic prosthetic valve shown in Fig. 25. It can be noted that, in this embodiment, neither of the loops (252) is aligned (i.e., on the same axis as) any of the commissure fixation areas (251) of the structure. To achieve commissural alignment, it is desirable that at least one of the loops (252) be aligned with one of the commissure fixation areas (251) of the prosthetic valve.

[00105] An expert will easily understand that this invention can be used for the self-expanding prosthetic valve of any scaffold design. Distribution system for self-expanding THV:

[00106] As mentioned above, to achieve commissural alignment, additional features are required to be provided in the delivery system. This section describes these additional features for a delivery system, namely, a self-expanding THV catheter.

[00107] The delivery system for a self-expanding THV consists of a catheter and a loading system. The loading system is used to load the prosthetic valve onto the catheter stem in either the radially collapsed or crimped condition. A person skilled in the art is well acquainted with various designs of the delivery system for a self-expanding THV. The commissure alignment method described here is applicable to the delivery system for any commercially available self-expanding THV system design. Petition 870260030784, dated 01 / 04 / 2026, page 31 / 73 25 / 34

[00108] Fig. 26 shows a distal portion of a typical example of a delivery catheter. 260 for a self-expanding prosthesis such as a THV. Fig. 26A shows a cross-sectional view and Fig. 26B shows a perspective view of the distal portion of the 260 distribution catheter in Fig. 26, where 'A' designates the distal end and 'B' designates the proximal end.

[00109] It can be noted that the distal portion 260 of the distribution catheter shown in Figures 26, 26A, and 26B are examples. A specialist is well aware of the existence of delivery catheters of varying designs but with similar operating principles. A conventional delivery catheter for a self-expanding THV generally comprises an elongated outer stem 261, an intermediate stem 262 that passes coaxially through the outer stem 261, and an inner lumen 263 that passes coaxially through the intermediate stem 262. An atraumatic tip 264 is usually attached to the distal end of the inner lumen 263. A loop is provided at the proximal end of the delivery catheter (not shown in Figures 26, 26A, and 26B). The outer stem 261, the intermediate stem 262, and the inner lumen 263 (collectively referred to as “the tubes”) extend to the proximal end of the catheter and enter the interior of the stem. The inner lumen 263 acts as a guidewire lumen.The outer stem 261 can slide linearly relative to the intermediate stem 262 in the axial direction. The intermediate stem 262 and the inner lumen 263 are fixed and cannot slide relative to each other. The tubes are not rotatable relative to each other. The sliding movement mechanism of the outer stem 261 is normally housed in the proximal loop. The loop may also be provided with other mechanisms as required for the operation of the delivery catheter. As mentioned above, this description is of an exemplary and general nature. Delivery catheters with alternative design features are considered to be covered by the scope of this invention.

[00110] Normally, the outer stem 261 of the catheter is slid over the crimped prosthetic valve to maintain it in the radially collapsed (crimped) condition. Alternatively, a retention sheath is provided to cover the prosthetic valve to retain it in the radially collapsed (crimped) condition.

[00111] The self-expanding THV is normally mounted at the distal end of the inner lumen 263 in area 263A, near and proximal to the distal tip 264, in a radially collapsed / crimped condition (the prosthetic valve is not shown). The outer stem 261 is configured to cover the radially collapsed prosthetic valve to keep it in a crimped condition. A Petition 870260030784, dated 01 / 04 / 2026, page 32 / 73 A 26 / 34 delivery catheter of another design may have a retention sheath that covers the self-expanding THV in the radially collapsed condition. The prosthetic valve can be expanded by gradually retracting the outer stem 261 or the retention sheath in the proximal direction to uncover the prosthetic valve, allowing it to self-expand. Typically, the loop provided at the proximal end of the catheter houses a mechanism to effect the necessary movement of the outer stem 261 or the retention sheath in a controlled manner. As mentioned above, the tubing and the retention sheath (if provided) cannot rotate relative to each other.

[00112] The 260 delivery system can optionally be provided with a mechanism for flexing the distal end portion of the catheter shaft to facilitate its movement through the aortic arch. The flexing mechanism can also be housed in the proximal loop.

[00113] A hub or support 265 is generally provided on the intermediate shaft 262. The distal end of the support 265 of the exemplary embodiment is level with the distal end of the intermediate shaft 262. As shown in Figs. 26, 26A and 26B, the prosthetic valve is mounted in the inner lumen 263 in a radially collapsed (crimped) condition in the space 263A between the proximal end of the tip 264 and the distal end of the support 265. The proximal end of the prosthetic valve mounted in the inner lumen in a radially collapsed condition may abut the distal end of the support 265. The function of the support 265 is to retain the position of the prosthetic valve. Generally, as described above, the structure 250 of the prosthetic valve has at least one, or preferably at least two, loops or eyelets (252) at one of its ends. Support 265 is supplied with a corresponding number of tabs / blades (265A) at its distal end which fit into the handles / eyelets (252) on the frame 250.Alternatively, the holder 265 is provided with a corresponding number of receptacle areas at its distal end to receive the loop(s) or eyelet(s) of the crimped prosthetic valve. When the prosthetic valve is mounted in the internal lumen in the collapsed condition, the loops / eyelets (252) on the frame 250 are engaged in the tabs / blades / receptacle areas (265A) on the holder 265. This arrangement restricts the axial and rotational movements of the collapsed THV and maintains its position relative to the catheter shafts. Exemplary embodiments of Figs. 26, 26A and 26B show the holder 265 with receptacle area 265A to receive the loop(s) or eyelet(s) (252) of the frame 250. Petition 870260030784, dated 01 / 04 / 2026, page 33 / 73 27 / 34

[00114] The support 265 is not rigidly fixed to the intermediate rod 262 or the inner lumen 263. It can rotate freely relative to the intermediate shaft and the inner lumen. A locking screw 265B, as shown in Figs. 26, 26A and 26B, is provided on the support 265 to lock the position of the support 265 to restrict its rotational and translational movement relative to the intermediate rod 262 as well as the inner lumen 263. A specialist is aware of several other methods of locking and unlocking components such as a support on a rod as an inner lumen. For the exemplary embodiment described, locking is achieved by tightening the screw 265B. When the screw 265B is loosened, the support 265 is unlocked and is free to rotate.

[00115] The outer diameter of the support 265 (together with the screw tightened in the inner lumen) is smaller than the inner diameter of the outer rod 261 and the retaining sheath (if supplied), so that the outer rod 261 / retaining sheath can slide on the support 265.

[00116] Fig. 27 shows the assembly of the typical distribution catheter 270, the distal portion of which 260 is described above and shown in Figs. 26, 26A and 26B. It may be noted that the distribution catheter of Fig. 27 is only exemplary. This invention is considered to cover distribution catheters of other models. The embodiment of Fig. 27 shows the outer rod 261 covering the prosthetic valve (not shown) in a radially collapsed (crimped) condition at the distal end A, proximal to the tip 264. As mentioned earlier, the prosthetic valve may alternatively be covered with a retention sheath instead of the outer rod. A loop 271 is provided at the proximal end B of the distribution catheter housing various mechanisms for the operation of the distribution catheter. Points for flushing the rods / tubes of the distribution system may be provided on the loop. Two exemplary washing points 272A and 272B are shown in Fig. 27.

[00117] The delivery catheter system for a self-expanding THV is typically supplied with a loading system. Prior to the procedure, the operator may manually crimp the prosthetic valve over the inner lumen and cover it with the outer shaft or a retaining sheath using this loading system. The loading system generally consists of one or more tubular and conical components that assist in the gradual reduction of the prosthetic valve's diameter. This operation is usually performed at a lower temperature, generally in an ice bath to allow for the transition. Petition 870260030784, dated 01 / 04 / 2026, page 34 / 73 28 / 34 of the shape memory alloy to its martensitic state and the diameter of the prosthetic valve is reduced without distorting the struts. The prosthetic valve is crimped over the inner lumen 263 in its designated location 263A, as described above, and covered with the outer stem 261 or the retaining sheath to retain it in the crimped condition over area 273. There may be other accessories that further assist in the crimping procedure. Each manufacturer of self-expanding devices, such as the THV system, provides a loading system of different design. An expert is quite familiar with different loading systems provided by suppliers of self-expanding THVs.

[00118] The self-expanding THV is implanted by gradually retracting the outer stem 261 or the retention sheath in the proximal direction to expose the prosthetic valve, allowing it to self-expand at human body temperature. As mentioned above, this operation is controlled with the help of the mechanism that is normally provided as part of the proximal loop 271.

[00119] There are several self-expanding prosthetic valves available on the market with delivery catheters and loading system components of different designs. However, the basic loading and implantation method is similar in all of them. The loading system of all of them has one or more tubular and conical-shaped components that play a key role in reducing the diameter of the prosthetic valve.

[00120] The delivery catheter for a self-expanding prosthetic valve may optionally include a flexing mechanism whereby the distal portion of the catheter stem can be flexed to facilitate movement through the aortic arch.

[00121] The same basic principles described earlier for a balloon-expandable prosthetic valve can be applied to a self-expanding prosthetic valve to achieve commissural alignment. Further changes are required to achieve commissural alignment for a self-expanding THV. These changes do not alter the system design.

[00122] The outer stem 261 of the delivery catheter 270 for the self-expanding THV is supplied with single or multiple aligners 266 in the same manner described previously for the delivery system for a balloon-expandable THV. In the case of multiple aligners 266, they are spaced from each other, preferably equidistant from each other in a single orientation, i.e., on the same axis described previously for the delivery system for balloon-expandable THV. A convenient way to mark the aligners Petition 870260030784, dated 01 / 04 / 2026, page 35 / 73 29 / 34 266 is such that they follow the same axis as the company logo on the proximal handle 271 and continue on the same axis (i.e., maintain the same orientation) throughout. This is merely a convenient way of marking the aligners 266. It is not necessary to follow the same axis as the company logo. Fig. 26 shows an embodiment featuring one of the multiple aligners 266 at the distal end 260 of the outer rod 261. It may be noted that the outer rod 261 may alternatively be provided with a single continuous aligner 266A in place of multiple aligners 266, as shown in Fig. 28, which shows the distal end portion of the delivery catheter 270.

[00123] The distal end of the single or more distal aligner 266 / 266A on the catheter shaft 261 terminates at the distal end of the outer shaft 261. If a retention sheath is provided, the aligner 266 / 266A may also be provided in the retention sheath.

[00124] Several alternative ways of providing aligners described above for the delivery catheter for a balloon-expandable HRT, such as painting, strip bonding, laser beam marking, and other methods known in the art, are also applicable to the delivery catheter for the self-expanding HRT. The color of the aligners may contrast with the color of the outer stem to improve the visibility of the plane. The aligners may also be radiopaque so that they are also visible under fluoroscopy. In the case of the outer stem 261 being marked with multiple aligners 266, as mentioned above for the delivery system for a balloon-expandable HRT, they may be spaced from each other in a single orientation, i.e., on the same axis, preferably equidistant from each other.

[00125] As previously described and shown in Fig. 25, the structure 250 of a self-expanding prosthetic valve has loops / eyelets 252 at its outlet end A. To achieve commissural alignment, a convenient method is to axially align at least one of the loops / eyelets 252 on the frame 250 to one of the commissures 251 of the THV. To differentiate this loop / eyelet 252 from other loops / eyelets, identification marks may be provided on this loop / eyelet. These identification marks should be easily visually identifiable.

[00126] Exemplary identification markings 311 on a handle / eyelet are shown in Fig. 31A. The sole purpose of providing identification markings is to distinguish the loop / eyelet that is axially aligned with one of the THV's 251 commissures. Therefore, other methods of making identification markings on the loop / eyelet may also be used. Petition 870260030784, dated 01 / 04 / 2026, page 36 / 73 30 / 34

[00127] If at least one of the loops / eyelets 252 on the structure is not axially aligned with one of the THV's commissures 251, the method for orienting the crimped valve would be relatively simple as described below.

[00128] A 210 confirmation meter as previously described for the system Balloon-expandable THV, as shown in Figs. 21A-D and 22A / B, plays a direct role for the self-expanding THV. As described previously, the angled markings 213A-D are provided on at least one side of the confirmation gauge 210. The function of the confirmation gauge 210 is described in the crimping method below. THV self-expanding crimping method A skilled person is well aware of the crimping procedure for a self-expanding THV. Conventionally, no attention is given to the orientation of the commissure areas 251 of the structure 250 during the assembly of the THV onto the stem of a delivery catheter 270. Therefore, there is no conscious effort to achieve commissural alignment. The crimping method for a self-expanding THV to achieve commissural alignment is described below, in a step-by-step format. 1. The AoCA for the patient is determined in the same manner described previously. This method does not depend on the type of THV (whether balloon-expandable or self-expanding). To demonstrate the method, as an example, the measured AoCA is assumed to be an obtuse angle, as shown in Fig. 14A / 14B. 2. The AoCA is identified by the exemplary angle markings 213B or 213D on the confirmation gauge 210. Figs. 29A and 29B show two exemplary embodiments of a confirmation gauge with clock angle markings covering half the circumference of the central aperture 212 in Fig. 29A and the complete circumference of the central aperture 212 in Fig. 29B. The AoCA can be identified by making a mark 291A / 291B on the confirmation gauge as shown in Figs. 29A and 29B respectively. It may be noted that any other method of angle marking (such as in degrees) is equally effective. Furthermore, any other method of identifying the AoCA on the confirmation gauge is also equally effective. 3. As shown in Fig. 30, the distal end 260 of the delivery catheter 270 is inserted into the central opening 212 of the confirmation gauge 210 on one side of the confirmation gauge 210, so that a portion of the outer stem 261 and the support 265 Petition 870260030784, dated 01 / 04 / 2026, page 37 / 73 31 / 34 project out from the other side of the confirmation gauge 210. This arrangement is shown in Fig. 30A as an expanded view for clarity. The support 265 can be held in the locked position. The catheter is oriented so that the aligner(s) 266 / 266A face upwards, as shown in Figs. 30 and 30A. 4. This step is followed when at least one of the handles / eyelets 252 on the structure 250 is axially aligned with one of the corners 251 of the THV and is provided with the identification marks 311. The support 265 is unlocked, for example, by loosening the locking screw 265B on the support 265. The support 265 is rotated on the intermediate axis 262 so that one of the tabs / blades or receptacle areas on the support 265A is aligned with the AoCA marking 291A on the confirmation gauge 210, as shown in Fig. 30. For clarity, Fig. 30A shows an expanded view of the front surface of the confirmation gauge 210 and the support 265. The dashed line in these figures shows the alignment of one of the receptacle areas 265A of the support 265 with the AoCA marking 291A on the confirmation gauge. 210. This area of ​​the receptacle is shown as 265A'.In this position, the 265 bracket is locked, for example, by tightening the 265B locking screw, taking care that the 266 / 266A aligner on the external axis 261 remains oriented upwards at the same time. Since the tubes cannot rotate relative to each other and the 265 bracket is locked in position, the orientation of the catheter tubes and the 265 bracket is fixed relative to each other based on the AoCA. The 265 bracket remains locked thereafter. 5. The crimping of the prosthetic valve is performed using the loading system in such a way that the loop / eyelet on the frame 250 of the prosthetic valve that has identifying mark(s) (the one that is aligned with one of the corners of the prosthetic valve) is aligned with the tab / slide 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 aligned in this way. For clarity, only the valve structure is shown in Fig. 31, without leaflets and other valve parts. A close-up view is shown in Fig. 31A for clarity. Exemplary identification marks 311 are also shown on the loop / eyelet 252' that is aligned with one of the corners of the valve. Fig. 31B shows a side view of the assembly shown in Figs. 31 and 31A. At all times, as shown in Figs. 31 and 31A, the aligner(s) 266 / 266A must remain facing upwards. Figs.31 and 31A show the exemplary version with a meter. Petition 870260030784, dated 01 / 04 / 2026, p. 38 / 73 32 / 34 confirmation gauge 210 marked with clock angles 213B and receptacle areas 265A and 265A' to receive handles / eyelets 252 and 252'. The component identification numbers with apostrophes refer to the component with specific characteristics. 265A refers to the receptacle area on the support 265, while 265A' refers to one of the receptacle areas that is aligned with AoCA marking 291A on confirmation gauge 210. Similarly, 252 refers to the handles or eyelets on the prosthetic valve structure 250, while 252' refers to the handle / eyelet that is aligned with one of the commissure attachment areas 251 of the prosthetic valve structure 250. 6. The loops / eyelets 252 and 252' are then engaged in the tabs / blades or receptacle areas 265A and 265A' on the support 265, as shown in Fig. 32 and in a close-up view in Fig. 32A, so that (a) the loop / eyelet of the structure 250 that is aligned with one of the valve commissures (with identification mark(s)) 252' is engaged with the receptacle area 265A' of the support 265 that is aligned with the AoCA marked on the confirmation gauge 210 and (b) the aligner 266 / 266A on the outer shaft 261 or the retaining sleeve (if supplied) is facing upwards. Fig. 32B shows a side view of the arrangement shown in Fig. 32. Figures 32 and 32A / B show an exemplary embodiment of the delivery catheter where the support has receptacle areas. In this way, one of the areas of the THV commissure is axially aligned with AoCA and, simultaneously, the aligner(s) point upwards, as described for balloon-expandable THV. 7. The outer stem 261 or the retention sheath (if supplied) of the delivery catheter is then moved to cover the crimped valve 313 and the holder 265 to retain the crimped valve 313 in this position in the radially collapsed condition. 8. The system is now ready to introduce the catheter into the patient's vasculature using the recommended introducer sheath.

[00129] If any of the eyelets / loops 252 of the frame 250 are not axially aligned with one of the corners of the THV, the crimping procedure becomes somewhat complex. In this case, the support 265 is unlocked and rotated on the intermediate rod 262 so that one of the tabs / blades or receptacle areas 265A on the support is oriented so that when the eyelet / loop 252 of the crimped THV is engaged with the tab / blade or receptacle 265A on the support, one of the corners 251 of the THV is aligned with the AoCA marking 291A on Petition 870260030784, dated 01 / 04 / 2026, p. 39 / 73 33 / 34 confirmation gauge 210. The key point is to align one of the THV commissures with AoCA while keeping the 266 / 266A aligner(s) facing upwards. Deployment method

[00130] The method for implanting the self-expanding THV mounted on the delivery catheter using the crimping method mentioned above, to obtain commissure alignment, is described below. 1. Insert the distal end of the delivery catheter, which has the radially collapsed prosthetic valve mounted on it, into the patient's vasculature through an introducer sheath, keeping the 266 / 266A aligner(s) facing upwards. If the aligners follow the axis of the company logo on the proximal loop, it is advisable to keep the company logo facing upwards. This orientation should not be altered during the implantation procedure. Therefore, do not tighten the delivery system. If inadvertent torque occurs during THV system insertion due to anatomical challenges, the aligners can help the operator reorient the system for detorque. However, the system can be flexed if it has a flexion mechanism. 2. Navigate the delivery catheter through the patient's vasculature to the patient's aortic annulus. 3. Once the prosthetic valve and balloon have passed through the aortic annulus, one of the commissures of the prosthetic valve is expected to align with a native commissure. The other commissures of the prosthetic valve would then automatically align with the other native commissures. 4. Position the prosthetic valve at the desired location for implantation. 5. Implant the prosthetic valve by removing the outer stem or retention sheath proximally to expose the crimped prosthetic valve, allowing it to self-expand and be implanted at the target site. The expected final implantation with commissural alignment is shown in Fig. 24.

[00131] The specialist will readily understand that this method is also applicable to different types of bicuspid aortic valve anatomy. In bicuspid anatomy, the specialist would measure the AoCA angle to obtain minimal commissural misalignment using the technique mentioned above. Petition 870260030784, dated 01 / 04 / 2026, p. 40 / 73 34 / 34

[00132] This invention is based on three known factual aspects, namely: (a) fluoroscopic visualization is a mirror image of the anatomical / AP visualization; (b) a THV that is implanted under fluoroscopic guidance with only one commissure aligned towards the mirror image of the middle CCD according to the fluoroscopic view (and, for example, TCMS), will in fact be implanted anatomically towards the CNC-CCE commissure with minimal misalignment; and (c) a THV that is implanted under fluoroscopic guidance with only one commissure aligned towards the mirror image of the middle CCE according to the fluoroscopic view (and, for example, TCMS), will in fact be implanted anatomically towards the CCD-CNC commissure with minimal misalignment.

[00133] Thus, by using this technique, it is possible to predictably ensure minimal misalignment of the commissures of the native aortic valve with the commissures of the prosthetic valve.

[00134] The scope of the invention is limited only by the appended patent claims. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are intended to be exemplary and that the actual parameters, dimensions, materials, and / or configurations will depend on the specific application or applications for which the teachings of the present invention are used. Petition 870260030784, dated 01 / 04 / 2026, page 41 / 73

Claims

1 / 1 CLAIMS 1. Confirmation gauge (210), characterized in that it comprises: a. a central opening (212) that can accommodate a prosthetic valve at least partially crimped into a delivery system, wherein the delivery system is for delivering the prosthetic valve to a patient; and b. a plurality of angular markings (213A-213D) provided on at least one side of the confirmation gauge (210), around the central opening (212).

2. Confirmation gauge, according to claim 1, characterized in that the confirmation gauge (210) has a square structure.

3. Confirmation gauge, according to claim 1, characterized in that the confirmation gauge (210) has a rectangular structure.

4. Confirmation gauge, according to claim 1, characterized in that the confirmation gauge (210) has a circular structure.

5. Confirmation gauge, according to claim 1, characterized in that the angles of the angular markings (213A, 213C) are expressed as degrees.

6. Confirmation gauge, according to claim 1, characterized in that the angles of the angular markings (213B, 213D) are expressed as clock angles.

7. Confirmation gauge, according to claim 1, characterized in that the angular markings (213A-213D) correspond to the angular markings (193) on a crimper (190).

8. Confirmation gauge, according to claim 1, characterized in that a line (291A, 291B) corresponding to a Commissural Alignment Angle (AoCA) of a native aortic valve is marked on the angular markings (213A-213D) of the confirmation gauge (210) for easy identification of the AoCA on the angular markings (213A-213D). Petition 870260030784, dated 01 / 04 / 2026, p. 42 / 73

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