Expandable frames for improving hemodynamic performance in transcatheter heart valve replacement

Abstract

A replacement heart valve prosthesis for transcatheter repair of a natural heart valve includes a valve structure mounted to the outer surface of an expandable frame. The frame includes an expandable region proximal to the distal end of the frame and a cusp valve region proximal to the proximal region, the cusp valve region including a plurality of valve attachment features. The valve structure can be attached to the valve structure at least at the valve attachment features. The replacement heart valve prosthesis of this disclosure can be a more durable and longer-lasting valve, which adds benefits by placing valve tissue between the expandable frame and the natural heart tissue.

Description

Technical Field

[0001] This disclosure relates to a novel and advantageous expandable frame for transcatheter replacement of heart valve prostheses and a method for attaching valve structures to the frame. Background Technology

[0002] The background description provided herein is intended to provide a general overview of the context of this disclosure. Within the scope of this background section, neither the inventors' work nor descriptions that may not conform to the prior art at the time of submission are expressly or implicitly acknowledged as prior art to this disclosure.

[0003] Transcatheter valve replacement (TVR) is a minimally invasive cardiac procedure used to repair or replace heart valves using an implantable valve prosthesis delivered via a catheter to the patient's natural valve. The implantable valve prosthesis typically comprises an expandable frame with multiple flat prosthetic leaflets attached to its interior. The prosthetic leaflets are designed to mimic the movement of a healthier natural valve leaflet. The expandable frame can be self-expanding using shape memory alloys, or it can be expandable using a balloon or otherwise mechanically expandable when deployed into the natural valve. Transcatheter valve replacement prostheses have been developed for the aortic, mitral, and tricuspid valves. The TVR procedure typically involves introducing a catheter into the patient's vascular system via the femoral artery, where the valve prosthesis is loaded into the catheter and advanced through the patient's vascular system to the natural valve.

[0004] Before the development of these minimally invasive transcatheter valve replacement procedures, most patients requiring heart valve repair were limited to surgical replacement with significant incisions. However, for many patients needing heart valve repair, surgical repair carries relatively high risks, or the patient is not a suitable candidate for surgery. Regarding the aortic valve, transcatheter aortic valve replacement (TAVR) has been widely adopted by clinicians worldwide as an alternative to surgical replacement for high-risk patients with severe aortic stenosis or similar conditions. After decades of numerous procedures, TAVR has been shown to improve long-term survival in these patients. Furthermore, in recent years, several studies involving both balloon-expandable and self-expanding TAVR prostheses have demonstrated the effectiveness of TAVR procedures in patients with lower surgical risks, and in 2019, the U.S. Food and Drug Administration expanded the indications for TAVR to include these low-risk patients.

[0005] The development of TAVR prostheses and related existing technologies has primarily focused on mechanisms and methods for delivering the prosthesis to the natural valve, for positioning or repositioning the prosthesis relative to the natural valve structure or surrounding anatomy, and for reducing the French size of the catheter to improve delivery through the blood vessels. However, this development has not paid particular attention to the long-term use of the prosthesis and its hemodynamic performance over time. Many TAVR prostheses currently used in these procedures have shown significant calcification and deterioration or degradation. Over time, typically between 5 and 15 years, many TAVR valve prostheses degenerate and eventually fail, requiring valve repair. In recent years, a second valve can be provided to patients with failed TAVR prostheses in a TAVR procedure called "valve-in-valve." In these procedures, a new transcatheter valve is inserted into the lumen of the failed TAVR valve, thereby pushing the prosthetic leaflet open. Inserting a valve into the lumen of a failed TAVR valve inevitably restricts or reduces the effective orifice area, thus limiting the hemodynamic performance of the second valve.

[0006] As younger, lower-risk patients receive TAVR prostheses, there is a need for more durable valves that can effectively resist prosthesis calcification and degeneration. Furthermore, there is a need in the art for a durable heart valve that, in addition to its long lifespan, also achieves improved hemodynamic performance. Summary of the Invention

[0007] The following presents a simplified overview of one or more embodiments of this disclosure in order to provide a basic understanding of these embodiments. This overview is not a broad summary of all conceived embodiments and is neither intended to identify key or essential elements of all embodiments nor to indicate the scope of any or all embodiments.

[0008] This disclosure relates to a novel and advantageous frame for valve prostheses that minimizes wear on valve structures attached to the frame while maximizing the effective orifice area of ​​the prosthesis. The effective orifice area of ​​a valve is an important indicator of its hemodynamic performance.

[0009] In some embodiments, as described herein, a valve structure including at least one leaflet may be mounted to the outer surface of a frame. Prior art valves typically have prosthetic leaflets mounted conversely to the inner surface of the frame within the lumen of the frame. With these prior art valves, when deployed in a natural valve, the metal alloy frame abuts against the patient's natural heart tissue, which can lead to inflammation in that area, calcification of the prosthesis, and performance problems with the valve prosthesis, such as paravalvular leakage. By conversely mounting the valve structure to the outside of the valve, the metal alloy frame no longer abuts against the patient's natural heart tissue, and inflammation from the frame can be reduced. The inner surface of the frame may define a lumen, and the frame may be designed to allow the cusp or leaflet of the valve structure to coapt centrally within the lumen of the frame to close the valve. Of course, in other embodiments of the invention described herein, the valve structure may be mounted to the inner surface of the frame of this disclosure.

[0010] In at least one embodiment, a replacement heart valve prosthesis for transcatheter repair of a natural heart valve includes a frame and a valve structure. The frame has a distal end, a proximal end, and a length between the distal and proximal ends. The frame also includes an outer surface and an inner surface defining an inner lumen. The frame is expandable from a non-expanded state to an expanded state. The frame also includes: an expandable region adjacent to the distal end of the frame; and a cusp valve region adjacent to the proximal region, the cusp valve region including a plurality of valve attachment features. The valve structure is mounted to the outer surface of the frame, wherein the valve structure is attached to the valve structure at least at the valve attachment features. In some embodiments, the cusp valve region includes a plurality of posts. In at least one embodiment, the posts are connected to circumferentially adjacent posts by struts, the struts defining cusp valve orifices. The valve structure may include at least two leaflets. Each leaflet may span an adjacent cusp valve orifice, and then the leaflet passes through the cusp valve orifice into the inner lumen of the frame. In at least one embodiment, the struts are bow-shaped struts.

[0011] In at least one embodiment of this disclosure, a replacement heart valve prosthesis for transcatheter repair of a natural valve includes a frame and a valve structure attached to the frame, the valve structure including at least one leaflet. The frame may have an outer surface and an inner surface defining a lumen. In some embodiments, the valve structure is externally mounted to the frame such that the inner surface of the valve abuts against the outer surface of the frame. In other embodiments, the valve structure is internally mounted to the frame such that the outer surface of the valve structure abuts against the inner surface of the frame. The frame may be expandable from a non-expandable state to an expanded state. The frame may have a distal end, a proximal end, and a length between the distal and proximal ends. The frame may have: an expandable region defining the distal end of the frame and extending toward the proximal end of the frame; and a plurality of valve columns extending proximally from the expandable region. The expandable region may have at least a first row of cells at the distal end of the expandable region and a second row of cells at the proximal end of the expandable region. In some embodiments, the expandable region may additionally have a plurality of intermediate rows of cells between the first and second rows of cells. Each valve column includes a valve attachment feature, and the valve structure can be attached to the frame at least at the valve attachment feature.

[0012] In some embodiments, each valve column has a proximal end and a distal end, and a length between the proximal and distal ends, wherein the length of the valve column is between 25% and 75% of the length of the frame. In some embodiments, circumferentially adjacent valve columns are equidistantly positioned relative to each other around the outer periphery of the frame. In some embodiments, the frame may have two valve columns. In other embodiments, the frame may have three valve columns. In still other embodiments, the frame may have more than three valve columns.

[0013] In some embodiments, the valve structure may include at least two shaped leaflets having a fusion region between them, the fusion region of the valve structure being attached to a post. In some embodiments, the valve structure includes a single piece of biomaterial. In some embodiments, the valve structure includes three leaflets shaped into the single piece of biomaterial. In some embodiments, the biomaterial includes a polymer, bovine tissue, porcine tissue, or pericardium.

[0014] In some embodiments, the column may further include a coupling alignment marker. In at least one embodiment, the coupling alignment marker is a radiopaque marker.

[0015] While several embodiments have been disclosed, other embodiments of the present disclosure will become apparent to those skilled in the art from the following detailed description, which illustrates and describes illustrative embodiments of the invention. As will be appreciated, modifications can be made to the various embodiments of the present disclosure in various obvious aspects, all without departing from the spirit and scope of the present disclosure. Therefore, the drawings and detailed description should be considered illustrative rather than restrictive. Attached Figure Description

[0016] Although this specification concludes with claims that specifically point out and expressly assert the subject matter regarded as forming the various embodiments of this disclosure, it is believed that this disclosure will be better understood from the following description taken in conjunction with the accompanying drawings, wherein:

[0017] Figure 1A-1B Schematic diagrams of the valve prosthesis of the present invention during systole and diastole are shown respectively, wherein the valve structure is mounted on the outside of the frame.

[0018] Figure 2 This is a perspective view of an expandable frame in an expanded state according to at least one embodiment of the present disclosure.

[0019] Figure 3 It is in a state of expansion. Figure 2 The diagram shows a planar representation of the expandable frame.

[0020] Figure 4 It is in an unexpanded state. Figure 2 The diagram shows a planar representation of the expandable frame.

[0021] Figure 5 This is a perspective view of an expandable frame in an expanded state according to at least one embodiment of the present disclosure.

[0022] Figure 6 It is in a state of expansion. Figure 5 The diagram shows a planar representation of the expandable frame.

[0023] Figure 7 It is in an unexpanded state. Figure 5 The diagram shows a planar representation of the expandable frame.

[0024] Figure 8 This is a perspective view of an expandable frame in an expanded state according to at least one embodiment of the present disclosure.

[0025] Figure 9 It is in a state of expansion. Figure 8 The diagram shows a planar representation of the expandable frame.

[0026] Figure 10 It is in an unexpanded state. Figure 8 The diagram shows a planar representation of the expandable frame.

[0027] Figure 11 This is a perspective view of an expandable frame in an expanded state according to at least one embodiment of the present disclosure.

[0028] Figure 12 It is in a state of expansion. Figure 11 The diagram shows a planar representation of the expandable frame.

[0029] Figure 13 It is in an unexpanded state. Figure 11 The diagram shows a planar representation of the expandable frame.

[0030] Figure 14A It is according to at least one embodiment of the present disclosure having installed to Figure 11 A front view of a valve prosthesis with an expandable frame valve structure.

[0031] Figure 14B yes Figure 14A The top view of the valve prosthesis shown.

[0032] Figure 14C yes Figures 14A-14B A perspective view of the valve prosthesis shown.

[0033] Figure 15 This is a perspective view of an expandable frame in an expanded state according to at least one embodiment of the present disclosure.

[0034] Figure 16 It is in a state of expansion. Figure 15 The diagram shows a planar representation of the expandable frame.

[0035] Figure 17 yes Figure 16 The diagram shows a planar representation of the expandable frame in its unexpanded state.

[0036] Figure 18 This is a perspective view of an expandable frame in an expanded state according to at least one embodiment of the present disclosure.

[0037] Figure 19 It is in a state of expansion. Figure 18 The diagram shows a planar representation of the expandable frame.

[0038] Figure 20 yes Figure 18 The diagram shows a planar representation of the expandable frame in its unexpanded state.

[0039] Figure 21 This is a plan view of an expandable frame in an unexpanded state having at least one transmissive marker according to at least one embodiment of the present disclosure.

[0040] Figure 22 This is a planar schematic diagram of an expandable frame according to at least one embodiment of the present disclosure and a suturing pattern for attaching tissue to at least a portion of the expandable frame.

[0041] Figure 23AThis is a planar schematic diagram of the ligatures of a frame and the suture pattern for attaching the valve structure to the frame, as viewed from the outer surface of a valve prosthesis according to at least one embodiment of the present disclosure.

[0042] Figure 23B yes Figure 23A The diagram shows a planar schematic of the fusion columns and suture pattern of the frame, but viewed from the inner surface of the valve prosthesis.

[0043] Figure 24 It can be connected to Figures 23A-23B A perspective view of the valve structure of the frame shown. Detailed Implementation

[0044] This disclosure describes a novel and advantageous valve prosthesis having a frame for mounting the valve structure, and a method for mounting the valve structure to the frame. While the embodiments and techniques discussed below are relevant to aortic valve replacement, the invention of this disclosure is applicable to other valve replacements, such as mitral and tricuspid valves, which are also within the scope of this disclosure. Furthermore, while the figures and embodiments discussed below describe an aortic valve that typically has three leaflets, the invention of this disclosure is applicable to prostheses for bivalve aortic valves, which are also within the scope of this disclosure.

[0045] In the following detailed description, numerous specific details are set forth to provide a thorough understanding of some embodiments. However, those skilled in the art will understand that some embodiments can be practiced without these specific details. In other instances, well-known methods, procedures, and / or components have not been described in detail to avoid obscuring the discussion.

[0046] In at least some embodiments of this disclosure, the valve structure may be mounted to the expandable frame of the transcatheter valve prosthesis on the outer surface of the expandable frame, rather than on the inner surface of a typical frame. In such embodiments, the diameter of the valve structure may be larger than the diameter of the frame when the valve prosthesis is in its expanded state.

[0047] Figure 1A-1B A schematic diagram of a valve prosthesis 100 of the present disclosure is shown, viewed from one end of the prosthesis. The valve prosthesis 100 can be designed for supra-annular or intra-annular placement. The valve prosthesis 100 includes an expandable frame 102 having an inner surface 104 and an outer surface 106. The inner surface 104 of the expandable frame 102 defines a lumen 107. In some embodiments, the expandable frame may include a plurality of posts 108. The valve prosthesis 100 also includes a valve structure 110, such as... Figure 1A-1BAs shown, the valve structure is mounted to the outer surface 106 of the expandable frame 102. The valve structure 110 may include biomaterials, as discussed further below. The valve structure 110 may have an inner surface 112 and an outer surface 114 with a thickness between them. When attached to the expandable frame 102, the inner surface 112 of the valve structure 110 abuts against the outer surface 106 of the expandable frame 102. The valve structure 110 may have at least one leaflet 120. In a preferred embodiment for an aortic valve, the valve structure 110 may have at least three leaflets 120. The leaflets 120 are undulating or movable relative to the expandable frame 102 to allow the leaflets to mate with each other during diastole without regurgitation and to fully open during systole to promote at least adequate blood flow and improved hemodynamics. In at least some embodiments, the effective orifice area of ​​the valve prosthesis 100 is approximately 1.7 cm². 2 up to 3.5cm 2 Between. In at least some embodiments, the average effective orifice area of ​​the valve prosthesis 100 is approximately 2 cm². 2 up to 3.5cm 2 Between. In at least some embodiments, the average effective orifice area of ​​the valve prosthesis 100 is approximately 2.2 cm². 2 up to 3.5cm 2 Between. In at least some embodiments, the average effective orifice area of ​​the valve prosthesis 100 is approximately 2.5 cm². 2 up to 3.5cm 2 Between. In at least one embodiment, the average effective orifice area of ​​the valve prosthesis 100 is approximately 2.5 cm². 2 up to 3.5cm 2 The pressure gradient is between approximately 4 mmHg and 7 mmHg, and the Doppler velocity index factor is between 0.55 and 0.70. In at least one embodiment, the average effective orifice area of ​​the valve prosthesis 100 is approximately 2.5 cm². 2 up to 3.5cm 2The pressure gradient is between approximately 4 mmHg and 10 mmHg, and the Doppler velocity index factor is between 0.55 and 0.70. When deployed into a patient's natural heart valve, a valve structure with tissue mounted on an external frame can directly abut against the tissue of the natural heart valve, whereas a typical valve prosthesis's valve structure is instead mounted externally to the interior of an expandable frame, thus the metal expandable frame abuts against the tissue of the natural heart valve, which may accelerate inflammation. By allowing the valve structure 110 to directly abut against the tissue of the natural heart valve, inflammation can be reduced. Additionally, by placing the tissue outside the expandable frame, the valve prosthesis 100 can have a larger opening area, which can result in improved hemodynamics. Furthermore, by placing the tissue outside the expandable frame, the valve prosthesis 100 can have a reduced gradient across the valve during forward flow, which can also result in improved hemodynamics. Depending on the biomaterial used for valve structure 110, the biomaterial can even be remodeled with adjacent natural heart valve tissue to anchor valve structure 110 to the natural structure, which can prevent perivalvular leakage and reduce the risk of valve prosthesis migration. In such examples using this material, the valve prosthesis of this disclosure can eliminate the need for polymer skirts, fabric skirts, or expandable materials (e.g., foam) to prevent perivalvular leakage, which is typical in most commercial valve prostheses. In other examples, portions of valve structure 110 may have a coating such as an adhesive to help anchor valve structure 110 to the natural valve structure. Still other examples of valve prostheses of this disclosure may include polymer skirts, fabric skirts, or other perivalvular leakage solutions.

[0048] In some embodiments, the valve structure may further extend over at least a portion of both the inner and outer surfaces of the column 108. More specifically, the portion of the valve structure between the leaflets (which can be described as the commissural region of the valve structure) may be aligned with the column 108 and, in some embodiments, may wrap around the column 108 such that the inner and outer surfaces of the column 108 are covered with the tissue material of the valve structure. In some embodiments, the valve structure may also be folded over the distal end (or annular end) of the expandable frame to form a cuff, such that the valve structure is located at the distal end of the expandable frame on both the inner and outer surfaces of the expandable frame.

[0049] In some embodiments, the expandable frame 102 may be a self-expanding frame; in other embodiments, the expandable frame may be a balloon-expandable frame or a frame that expands mechanically in other ways. In yet another embodiment, the expandable frame may have a self-expanding region and a balloon-expandable region. For example, the region of the frame near the leaflet may be self-expanding to control the expansion of the leaflet region using a shape memory alloy, while the region of the frame closest to the annulus may be balloon-expandable to facilitate controlled placement within the annulus. The expandable frame 102 may have a constant diameter from distal to proximal. The expandable frame 102 may have a larger diameter at the proximal end relative to the distal end, or conversely, the expandable frame may have a larger diameter at the distal end relative to the proximal end, which effectively establishes a taper of the valve. In some embodiments, the expandable frame 102 may have a flared shape from distal to proximal.

[0050] The expandable frame 102 may be made of stainless steel, shape memory alloys, plastic deformation alloys, or combinations thereof. Examples of such alloy materials include, but are not limited to, nickel-titanium alloys (e.g., NITINOL® alloys), cobalt-chromium alloys (e.g., ELGILOY® alloys), platinum-tungsten alloys, tantalum alloys, and so on. Other alloys that can be used to form the frame include, but are not limited to, other cobalt-chromium alloys, titanium-cobalt-chromium-molybdenum alloys, and so on. In addition to these materials, the expandable frame 102 may also be made of polymers, biomaterials, or combinations thereof. In some embodiments, the expandable frame 102 may have a coating on at least a portion of one of the outer surface 106 or the inner surface 104. The coating may include polymers, including but not limited to polytetrafluoroethylene (PTFE), silicone, biopolymers, and other suitable polymers. In other embodiments, the coating may include a radiopaque material. In some embodiments, the coating may include a drug-eluting material.

[0051] Valve structure 110 may include tissue material. In some embodiments, the tissue material may be a biological material. In some embodiments, the tissue material may be a cross-linked collagen-based biomaterial comprising acellular or cellular tissue selected from the group consisting of cardiovascular tissue, heart tissue, heart valves, aortic root, aortic wall, aortic leaflets, pericardial tissue, connective tissue, dura mater, dermal tissue, vascular tissue, cartilage, pericardium, ligaments, tendons, blood vessels, umbilical cord tissue, bone tissue, fascia, submucosal tissue, and skin. In some embodiments, the tissue material is an implantable biomaterial, such as the biomaterial described in the publication of co-owned U.S. Patent No. 9,205,172, filed December 21, 2005, entitled “Implantable Biomaterial and Method of Producing the Material,” the entire contents of which are incorporated herein by reference. In some embodiments, the cross-linked collagen-based biomaterial is treated with the ADAPT® treatment process, an anti-calcification treatment process for biomaterials that leaves no residual DNA and has over a decade of clinical data demonstrating no calcification when used in cardiac surgery. In some embodiments, the tissue material may be artificial tissue. In some embodiments, the artificial tissue may include a monolithically molded or shaped polymer. In some embodiments, the artificial tissue may include polytetrafluoroethylene, polyethylene terephthalate, other polymers, and other polymer coatings. In some embodiments, valve structure 108 may include shaped tissue material. More particularly, at least some or all of the leaflets 120 of valve structure 110 may include shaped tissue material. In some embodiments, valve structure 110 including leaflets 120 is a monolithic three-dimensional valve structure made of monolithic tissue material, such as the valve described in the commonly owned U.S. Application Serial No. 16 / 129235 entitled “Reduced Suture Heart Valve Replacement,” the entirety of which is incorporated herein by reference.

[0052] Figure 2-10 Various embodiments of expandable frames for valve prostheses are illustrated, which provide improved hemodynamic performance of the valve prosthesis according to the invention. Each expandable frame depicted in these figures and discussed further below can be constructed from the frame materials discussed above. Furthermore, each expandable frame can be attached to a valve structure, which can be constructed as described above. In some embodiments, the valve structure is mounted externally to the frame, while in other embodiments, the valve structure can be mounted internally to the frame.

[0053] Figure 2-4 An embodiment of an expandable frame 200 for use in the prosthesis of this disclosure is shown. In some embodiments, a valve structure (not shown) is mounted to the exterior of the frame 200, while in other embodiments, the valve structure (not shown) may be mounted to the interior of the frame 200. Figure 2A perspective view of the expandable frame 200 in its expanded state is shown. Figure 3 It shows the state of expansion. Figure 2 A schematic diagram of the flat support mode of the expandable frame 200, and Figure 4 It shows the state of non-expansion. Figure 8 A schematic diagram of the flat support mode of the expandable frame 200.

[0054] The expandable frame 200 may have a proximal end 202 and a distal end 204 opposite to the proximal end 202, with the axial length of the expandable frame spanning between the proximal end 202 and the distal end 204. The expandable frame 200 may have an outer surface 206 and an inner surface 208 with a thickness between them. The inner surface 208 defines an inner lumen 210. The expandable frame 200 may have an expandable region 212 and a cusp valve region 214 adjacent to the expandable region 214. The cusp valve region 214 allows the leaflets of the valve structure to open beyond the outer surface 206, and in some embodiments, more particularly allows the leaflets to open beyond at least the outer surface 206 of the expandable region 212 of the expandable frame (which can be considered the ventricular portion of the frame). This can effectively induce a tapering effect, where the area defined by the free edge of the leaflet of the valve structure is larger than the area defined by the outer surface of the frame, thereby causing a reduced pressure gradient and an increased effective orifice area during forward flow. Due to the cell structure of the frame, existing valve prostheses do not allow the leaflets to open beyond the outer surface of the expandable frame.

[0055] The expandable region 212 can be responsible for anchoring or sealing the valve prosthesis. The expandable region 212 has a proximal end 216 and a distal end 218. The expandable region 212 includes a plurality of cells 220 defining an opening 221. Figure 2-3 In the illustrated embodiment, the opening 221 has different sizes and shapes. In other embodiments, the opening 221 may have the same size and shape.

[0056] Cells 220 can be arranged at least as a first row of circumferentially adjacent cells (shown generally as 222) at the proximal end 216 of the expandable region 212 and a second row of circumferentially adjacent cells (shown generally as 224) at the distal end 218 of the expandable region 212. In some embodiments, such as in Figure 2-4 In the illustrated embodiment, at least one circumferentially adjacent cell in the middle row (shown as 226 in general) may span between the circumferentially adjacent cells 222 in the first row and the circumferentially adjacent cells 224 in the second row.

[0057] Each cell 220 includes multiple struts 230. Each strut 230 can be a straight strut, or at least as shown in the image. Figure 2-4As shown, each strut can be a curved strut, or each strut can be a meandering strut with at least one bend or undulation. Each strut 230 can have a thickness, which can be uniform or varied along its length. Each strut in cell 220 can be connected to an adjacent strut at a node 232. The node 232 can include end nodes 234 located at the proximal end 216 and distal end 218 of the expandable region, which connect circumferentially adjacent struts 230 at each end 216, 218. The node 232 can also include row nodes 236 that connect circumferentially adjacent struts 230 in rows 222, 224, 226, or connect axially adjacent struts 230 in rows 222, 224, 226 to axially adjacent rows.

[0058] Turning now to the cusp valve region 214, which is designed to facilitate or assist movement of the leaflets of the valve structure attached to the expandable frame 200, the cusp valve region 212 has a proximal end 242 and a distal end 244 adjacent to the expandable region 212. The cusp valve region 214 includes a plurality of posts 246 for attaching the valve structure to the expandable frame 200. In some embodiments, the cusp valve region 214 may have two posts 246. In some embodiments, for example in Figure 2-4 In the illustrated embodiment, the cusp region 214 may have three columns 246. In other embodiments, the cusp region 214 may have any number of columns 246.

[0059] Each post 246 may have a distal end 248 and a proximal end 250, wherein the proximal end 250 defines the proximal end 242 of the cusp region 242. In some embodiments, the distal end 248 of the post 246 may be attached to an end nodule 234 at the proximal end 216 of the expandable region 212. In other embodiments, the distal end 248 of the post 246 may be attached to an arcuate strut spanning a circumferential distance between circumferentially adjacent posts 246, and the arcuate strut may be attached to the expandable region at one or more end nodules 234. In yet another embodiment, for example in Figure 2-4 In the illustrated embodiment, the distal end 248 of the column 246 may be attached to one or more cusp struts 251 of the cusp region 214, and each cusp strut may be attached to the expandable region 212 at one or more end nodules 234. As at least in Figure 3More specifically shown, each post 246 can be connected to a right cusp valve strut 251a and a left cusp valve strut 251b. In at least the illustrated embodiment, the combination of posts 246, right cusp valve strut 251a, and left cusp valve strut 251 forms a forked structure. In the illustrated embodiment, the right cusp valve strut 251a of the first post 246a and the left cusp valve strut 251b of the second post 246b (which is circumferentially adjacent to the first post 246a) are connected to the same end nodule 234 of the expandable region 212. Each post 246 has a side surface 252, and each right cusp valve strut has a side surface 253. The side surfaces 252 of posts 246a, 246b, right cusp valve strut 251a, and the side surface 253 of the left cusp valve strut 251 circumferentially adjacent to the right cusp valve strut 251b define a leaflet opening 254. Leaflet opening 254 allows the leaflets of the valve structure to traverse the outer surface 206 of the expandable frame 200. Leaflet opening 254 can also allow for improved coronary artery access.

[0060] Each post 246 may include at least one strut 255, which may include at least one attachment feature 256 disposed within the strut 255. The width of the strut 255 may be greater than the width of at least one strut 230 of the expandable region 214. At least in Figure 3 In the illustrated embodiment, the attachment feature 256 may include one or more openings 260. For example... Figure 3 As shown, opening 260 may be a hole 260a or one or more slots 260b. In other embodiments, attachment feature 256 may include a plurality of openings 260 that facilitate a particular suturing pattern, said openings including holes, slots, or slits. In other embodiments, the at least one attachment feature may include a hook, loop, pledget, or other attachment feature. In some embodiments, post 246 and / or attachment feature 256 may be further used to recapture or reposition the frame during or after deployment. In some embodiments, post 246, attachment feature 256, and / or one or more cusp valve struts 251 may be used in valve procedures to engage with a previously implanted valve prosthesis or with a valve prosthesis being implanted.

[0061] The cusp valve region 214 may also include one or more cusp valve region cells 270, which may be defined by one or more cusp valve connector struts 272. The cusp valve connector struts 272 may provide additional structure to the post 246 to handle stress generated by the cusp valve region when the valve pulsates between systole and diastole. The width of the cusp valve connector strut 272 may be greater than the width of at least one strut 230 of the expandable region 214. Figure 2-3As shown, the cusp region cell 270 has an opening 273 larger than the opening 221 of cell 220. In some embodiments, some of the cusp region cells 270a may be defined by at least one cusp strut 251, at least one tip connector strut 272, and one or more struts 230 located at the proximal end 216 of the expandable region 212. In some embodiments, other cusp region cells 270b may be defined by at least two cusp struts 251 and two cusp connector struts 272. In some embodiments, other cusp region cells 270c may also be defined by at least two struts 230 at the proximal end 216 of the expandable region 212 and two cusp connector struts 272. The cusp region cells 270a may each define an area larger than that of the cusp region cells 270b and 270c, respectively. The cusp region cells 270a may each have a different shape than those of the cusp region cells 270b and 270c, respectively. In other embodiments, the cusp region cell 270a may be smaller than the cusp region cells 270b and 270c, respectively. In one embodiment, the cusp region cell 270b may have substantially the same shape as the cusp region cell 270c, and in one embodiment, the cusp region cell 270b may have the same size as the cusp region cell 270c or a slightly larger size than the cusp region cell 270c. In other embodiments, the cusp region cell 270b may have a substantially different shape from the cusp region cell 270c. In still other embodiments, the cusp region cell 270b may be smaller than the cusp region cell 270c.

[0062] In some embodiments, the diameter of the cusp region 214 may be larger than the diameter of the expandable region 212. In some embodiments, the diameter of the cusp region 214 at its proximal end may be similar to the diameter of the expandable region 212 at its distal end. In some embodiments, the diameter of the cusp region 214 at its proximal end may be larger than the diameter of the expandable region 212 at its distal end. In at least one embodiment, the diameter of the cusp region 214 at its proximal end may be larger than its diameter at its distal end, such that the cusp region 214 has a tapered profile in its expanded state.

[0063] In some embodiments, Figure 2-3 In the expanded state shown, the axial length of the cusp region 214 is between approximately 25% and 75% of the axial length of the expandable frame 200. In some embodiments, in Figure 2-3 In the expanded state shown, the axial length of the cusp region 214 is between approximately 45% and 70% of the axial length of the expandable frame 200. In at least one embodiment, in Figure 2-3In the expanded state shown, the axial length of the cusp region 814 is between approximately 60% and 75% of the axial length of the expandable frame 200.

[0064] Figure 4 An expandable frame 200 in its unexpanded state is shown. Figure 4 As shown, all end nodules 232 at the distal end 218 of frame 200 are radially aligned. Figure 4 As shown, all the row nodes 236 are radially aligned, as are the end nodes 232 at the proximal end 216 of the expandable frame 200. Figure 2-3 The cells 220 of the expandable region 212 shown are different in their expanded state. In the unexpanded state, all cells 220 have the same shape and size.

[0065] In at least some embodiments, such as Figure 2-4 The expandable frame 200 shown is of supra-annular design. Due to the supra-annular design of the expandable frame 200, valve prostheses using this frame can have a reduced pressure gradient and an increased effective orifice area during forward flow, and therefore exhibit superior hemodynamics.

[0066] Figure 5-7 Depicting Figure 2-4 The variant of the expandable frame shown. Figure 5 A perspective view of the expandable frame 500 in its expanded state is shown. Figure 6 It shows the state of expansion. Figure 5 A schematic diagram of the flat support mode of the expandable frame 500, and Figure 7 It shows the state of non-expansion. Figure 5 A schematic diagram of the flat support configuration of the expandable frame 500. In some embodiments, the valve structure (not shown) is mounted to... Figure 5-7 The expandable frame 500 shown is external; in other embodiments, a valve structure (not shown) may be mounted inside the frame 500.

[0067] The expandable frame 500 may have a proximal end 502 and a distal end 504 opposite to the proximal end 502, with the axial length of the expandable frame spanning between the proximal end 502 and the distal end 504. The expandable frame 500 may have an outer surface 506 and an inner surface 508 with a thickness between them. The inner surface 508 defines a lumen 510. The expandable frame 500 may have an expandable region 512 and a cusp valve region 514 located proximal to the expandable region 510. The cusp valve region 514 allows the leaflets of the valve structure to open beyond the outer surface 506, and in some embodiments, more particularly allows the leaflets to open beyond at least the outer surface 506 of the expandable region 512 of the expandable frame (which can be considered the ventricular portion of the frame). This can effectively induce a constriction effect, where the area defined by the free edge of the leaflet of the valve structure is larger than the area defined by the outer surface of the frame, thereby causing a reduced pressure gradient and an increased effective orifice area during forward flow. Due to the cell structure of the frame, existing valve prostheses do not allow the leaflets to open beyond the outer surface of the expandable frame.

[0068] The expandable region 512 has a proximal end 516 and a distal end 518. The expandable region 512 includes a plurality of cells 520 defining an opening 521. Figure 5-6 In the illustrated embodiment, openings 521 have different sizes and shapes. In other embodiments, openings 521 may all have the same size and shape.

[0069] Cell 520 can be arranged at least as a first row of circumferentially adjacent cells (shown overall as 522) at the proximal end 516 of the expandable region 512 and a second row of circumferentially adjacent cells (shown overall as 524) at the distal end 518 of the expandable region 512. Although as Figure 5-7 As shown, only these two rows of cells 522 and 524 are provided. However, in other embodiments, the circumferentially adjacent cells in the middle row can be set as described in other embodiments of this document.

[0070] Each cell 520 includes multiple struts 530. Each strut 530 can be a straight strut, or at least as shown in the image. Figure 5-7 As shown, each strut can be a curved strut, or each strut can be a meandering strut with at least one bend or undulation. Each strut 530 can have a thickness, which can be uniform or varied along its length. Each strut 530 of cell 520 can be connected to an adjacent strut at a knot 532. The knot 532 can include end knots 534 located at the proximal end 516 and distal end 518 of the expandable region, the end knots connecting circumferentially adjacent struts 530 at each end 516, 518. The knot 532 can also include row knots 536 connecting circumferentially adjacent struts 530 in rows 522, 524.

[0071] Turning now to the cusp valve region 514, which is designed to facilitate or assist movement of the leaflets of the valve structure attached to the expandable frame 500, the cusp valve region 512 has a proximal end 542 and a distal end 544 adjacent to the expandable region 512. The cusp valve region 514 includes a plurality of posts 546 for attaching the valve structure to the expandable frame 500. In some embodiments, the cusp valve region 514 may have two posts 546. In some embodiments, for example in Figure 5-7 In the illustrated embodiment, the cusp region 514 may have three columns 546. In other embodiments, the cusp region 514 may have any number of columns 546.

[0072] Each column 546 may have a distal end 548 and a proximal end 550, wherein the proximal end 550 defines the proximal end 542 of the cusp region 542. Figure 5-7 In the illustrated embodiment, the distal end 548 of the column 546 may be attached to one or more cusp struts 551 of the cusp region 514, and each cusp strut 552 may be attached to the expandable region 512 at one or more end nodules 532. As at least in Figure 6 More specifically shown, each post 546 can be connected to a right cusp valve strut 551a and a left cusp valve strut 551b. In at least the illustrated embodiment, the combination of posts 546, right cusp valve strut 551a, and left cusp valve strut 552b forms a forked structure. In the illustrated embodiment, the right cusp valve strut 551a of the first post 548a and the left cusp valve strut 551b of the second post 548b (which is circumferentially adjacent to the first post 548b) are connected to the same end nodule 534 of the expandable region 512. Posts 548 all have side surfaces 552, and right cusp valve struts all have side surfaces 553. The side surfaces 552 of post 546a, 554 of post 546b, 553 of right cusp valve strut 251a, and 553 of the left cusp valve strut 251 circumferentially adjacent to the right cusp valve strut 251b define the leaflet opening 554. Leaflet opening 554 allows the leaflets of the valve structure to traverse the outer surface of the frame. Leaflet opening 554 can also allow for improved coronary artery access.

[0073] Each post 546 may include at least one strut 555, and the strut 555 may include at least one attachment feature 556 disposed within the strut 255. The width of the strut 555 may be greater than the width of at least one strut 530 of the expandable region 514. At least in Figure 3In the illustrated embodiment, attachment feature 556 may include a slot 560. In yet another embodiment, attachment feature 554 may include one opening or may include multiple openings 560 that facilitate a particular suturing pattern, the openings including holes, slots, or slits. In other embodiments, the at least one attachment feature may include a hook, loop, gauze, or other similar attachment feature. In some embodiments, post 546 and / or attachment feature 554 may be further used to recapture or reposition the frame during or after deployment. In some embodiments, post 546, attachment feature 554, and / or one or more cusp valve struts 551 may be used in valve procedures to engage with a previously implanted valve prosthesis or with a valve prosthesis being implanted.

[0074] The cusp valve region 514 may also include one or more cusp valve region cells 570, which may be defined by one or more cusp valve connector struts 572. The cusp valve connector struts 572 may provide additional structure to the post 546 to handle stress generated by the cusp valve region when the valve pulsates between systole and diastole. Figure 5-6 As shown, the cusp region cell 570 has an opening 573 larger than the opening 521 of cell 520. In some embodiments, some of the cusp region cells 570a may be defined by at least one cusp strut 551, at least one tip connector strut 572, and one or more struts 530 located at the proximal end 516 of the expandable region 512. In some embodiments, other cusp region cells 570b may be defined by at least two cusp struts 551 and two cusp connector struts 252. In some embodiments, other cusp region cells 570c may also be defined by at least four struts 5300 at the proximal end 616 of the expandable region 212 and two cusp connector struts 572. Circumferentially adjacent cusp connector struts may also be connected to each other by nodules or small struts as shown in 274.

[0075] In some embodiments, Figure 5-6 In the expanded state shown, the axial length of the cusp region 514 is between approximately 25% and 75% of the axial length of the expandable frame 200. In some embodiments, in Figure 5-6 In the expanded state shown, the axial length of the cusp region 514 is between approximately 45% and 75% of the axial length of the expandable frame 500. In at least one embodiment, in Figure 5-6 In the expanded state shown, the axial length of the cusp region 514 is between approximately 60% and 75% of the axial length of the expandable frame 500.

[0076] In some embodiments, the diameter of the cusp region 514 may be larger than the diameter of the expandable region 512. In some embodiments, the diameter of the cusp region 512 at the proximal end of the cusp region 514 may be similar to the diameter of the expandable region 512 at the distal end of the expandable region 512. In some embodiments, the diameter of the cusp region 512 at the proximal end of the cusp region 514 may be larger than the diameter of the expandable region 512 at the distal end of the expandable region 512. In at least one embodiment, the diameter of the cusp region 514 at the proximal end of the cusp region may be larger than its diameter at the distal end of the cusp region, such that the cusp region 512 has a tapered profile in the expanded state.

[0077] In some embodiments, the skirt or other periploidal leakage reduction features may be attached to the outer surface of the expandable frame 206.

[0078] Figure 7 An expandable frame 500 in its unexpanded state is shown. Figure 4 As shown, all end nodes 532 at the distal end 518 of frame 500 are radially aligned. Figure 7 As shown, all the row nodes 536 are radially aligned, as are the end nodes 532 at the proximal end 516 of the expandable frame 500. Figure 5-6 The cells 520 of the expandable region 212 shown exhibit different appearances in their expanded state; in the unexpanded state, all cells 520 have the same shape and size. More specifically, all cells in the first circumferential row of cells 522 appear to have the same shape and size in the unexpanded state, while... Figure 5-6 As shown, cell 520 has a different shape within cell 522 of the first cyclic column.

[0079] In some embodiments, with Figure 2-7 The expandable frame valve prosthesis shown has a length of 2.38 cm. 2 up to 3.76cm 2 The average effective orifice area (EOA) between [amounts]. In some embodiments, the average EOA can be 2.64 cm². 2 up to 3.53cm 2 Between. In other embodiments, the average EOA can be between 2.84 cm. 2 up to 3.30cm 2 Between. In at least one embodiment, the average EOA of the valve prosthesis 100 is approximately 2.5 cm. 2 up to 3.5cm 2 Between these values, the pressure gradient is between approximately 4 mmHg and 10 mmHg, and the Doppler velocity index factor (DVI) is between 0.55 and 0.70.

[0080] Figure 8-10Another embodiment of the expandable frame 800 of the present invention is depicted. When used with the valve structure described above, the expandable frame 800 can form a shorter supraannular valve prosthesis. The occlusion of the valve structure in this expandable frame can be between 45% and 70% of the leaflet height. Unlike some other embodiments described herein, Figure 8-10 The expandable frame 800 shown is primarily designed for valve structures to be installed near the inner surface of the expandable frame 800. Figure 8 A perspective view of the expandable frame 800 in its expanded state is shown. Figure 9 It shows the state of expansion. Figure 8 A schematic diagram of the support mode of the expandable frame 800, and Figure 10 It shows Figure 8 A schematic diagram of the support mode of the expandable frame 800 in its unexpanded state.

[0081] The expandable frame 800 may have a proximal end 802 and a distal end 804 opposite to the proximal end 802, with the axial length of the expandable frame spanning between the proximal end 802 and the distal end 804. In some embodiments, the axial length of the frame from the proximal end 802 to the distal end 804 is between about 18 mm and 24 mm. The expandable frame 800 may have an outer surface 806 and an inner surface 808 with a thickness between them. The inner surface 808 defines an inner lumen 810. In at least one embodiment, the diameter of the outer surface 806 of the expandable frame may be greater than the axial length of the frame from the proximal end 802 to the distal end 804. For example, in embodiments where the outer diameter of the valve is between about 25.5 mm and 26.5 mm, the axial length of the valve from the proximal end 802 to the distal end 804 is between about 20 mm and 22 mm. The expandable frame 800 may have an expandable region 812 and a cusp valve region 814 located proximal to the expandable region 810.

[0082] The expandable region 812 has a proximal end 816 and a distal end 818. The expandable region 812 includes a plurality of cells 820 defining an opening 821. In some embodiments, all cells 820 of the expandable region 812 may have substantially the same size and shape. In other embodiments, the cells 820 of the expandable region 812 have different sizes and shapes.

[0083] Cell 820 can be arranged at least as a first circumferential row of cells (shown overall as 822) at the proximal end 816 of the expandable region 812 and a second circumferential row of cells (shown overall as 824) at the distal end 818 of the expandable region 812. In some embodiments, a plurality of circumferential intermediate rows of cells (shown overall as 826) can span between the first circumferential row of cells 822 and the second circumferential row of cells 824. Figure 9As shown, the expandable frame 800 has two intermediate row cells 826 between the first circumferential row cell 822 and the second circumferential row cell 824.

[0084] Each cell 820 includes multiple struts 830. Each strut 830 can be a straight strut, or at least as shown in the image. Figure 9 As shown, each strut can be a curved strut, or each strut can be a meandering strut with at least one bend or undulation. Each strut 830 can have a thickness, which can be uniform or varied along its length. Each strut in cell 820 can be connected to an adjacent strut at a node 832. The node 832 can include end nodes 834 located at the proximal end 816 and distal end 818 of the expandable region, the end nodes connecting circumferentially adjacent struts 830 at each end 816, 818. The node 832 can also include row nodes 836 connecting circumferentially adjacent struts 830 in rows 822, 824, 826, or connecting axially adjacent struts 830 in rows 822, 824, 826 to axially adjacent rows.

[0085] The cusp valve region 814 has a proximal end 842 and a distal end 844. The cusp valve region 814 includes a plurality of posts 846 for attaching the valve structure to the expandable frame 800. In some embodiments, the cusp valve region 814 may have two posts 846. In some embodiments, for example in… Figure 8-10 In the illustrated embodiment, the cusp region 814 may have three pillars 846. In yet another embodiment, the cusp region may have any number of pillars 846. Each pillar 846 may have a proximal end 848 and a distal end 850 extending from the proximal end 842 of the cusp region 814 to the distal end 844. In some embodiments, the distal end 850 of the pillar 846 may be attached to an end nodule 834 at the proximal end 816 of the expandable region 812. In other embodiments, the distal end 848 may be attached to a strut 830 of the expandable region, and more particularly, to a strut of at least one cell 820 in the first circumferential row of cells 822. Each pillar 846 may include at least one strut 852 and at least one attachment feature 854 connected to the strut 852. One end of the strut 852 of the pillar is attached to the expandable region 812. The width of the strut 852 may be greater than the width of at least one strut 830 of the expandable region 814. The strut 852 may include a neck region 856 located at its proximal end, which connects the strut 852 to at least one attachment feature 854 of the post 846. The at least one attachment feature 854 may include a tab 858, within which at least one opening 860 is provided. Figure 8 As shown, the width of the connecting piece 858 can be greater than the width of the strut 852. At least in Figure 8In the illustrated embodiment, opening 860 may be a slot. In other embodiments, opening 860 may be a hole. In yet another embodiment, attachment feature 854 may have multiple openings 860 that facilitate specific stitching patterns, including holes, slots, or slits. In other embodiments, the at least one attachment feature may include a hook. In some embodiments, post 846 may be further used to recapture or reposition the frame after deployment.

[0086] Each column 846 defines at least a portion of at least one cusp region cell 870. For example... Figure 8-9 As shown, the cusp valve region cell 870 has an opening 872 larger than the opening 821 of cell 820. In some embodiments, the cusp valve region cell 870 may allow improved coronary artery access for the valve prosthesis 800. The cusp valve region cell 870 is defined by a strut 830 located at the proximal end 816 of the expandable region 812, at least one post 846, and a pair of cusp valve struts 874. Each cusp valve strut 874 may be a straight strut, or at least as shown in the diagram. Figure 9 As shown, each strut can be a curved strut, or each strut can be a meandering strut with at least one bend or undulation. In some embodiments, the cusp region cell 870 is defined by struts 852 of the column 846. Each strut 874 forming a pair of cusp region struts is connected to each other at the cusp nodule 876. In some embodiments, the cusp region cell 870 may be further defined by axial struts 880. Figure 9 As shown, the axial strut 880 can be circumferentially adjacent to the column 846. The first end 882 of the axial strut 880 can be connected to one of the pair of pointed struts at the connecting nodule 884, and its second end 886 can be connected to the end nodule 834. The axial strut 880 can be at least as shown... Figure 9 The strut shown can be a straight strut, or it can be a curved strut or a meandering strut with at least one bend or undulation. At least in Figure 8-9 In the illustrated embodiment, the cusp region cell is defined by eight struts: strut 852 of column 846, a pair of cusp struts 874, axial strut 880, and four adjacent struts 830 of the first circumferential row cell 822 located at the proximal end 816 of the expandable region 812. At least as Figure 8-9 As shown, in some embodiments, the opening 872 of the cusp region cell 870 can be... Figure 8-9 The expansion state shown forms a roughly heart-shaped periphery.

[0087] In some embodiments, Figure 8-9 In the expanded state shown, the axial length of the cusp region 814 is between approximately 25% and 75% of the axial length of the expandable frame 800. In some embodiments, in Figure 8-9In the expanded state shown, the axial length of the cusp region 814 is between approximately 30% and 50% of the axial length of the expandable frame 800. In at least one embodiment, in Figure 8-9 In the expanded state shown, the axial length of the cusp region 814 is between approximately 40% and 45% of the axial length of the expandable frame 800.

[0088] Figure 10 An expandable frame 800 in its unexpanded state is shown. Figure 10 As shown, all end nodes 832 at the distal end 818 of frame 800 are radially aligned. Figure 10 As shown, all row nodes 836 are radially aligned, as are the end nodes 832 at the proximal end of the expandable frame 800. Furthermore, row nodes 836 are axially aligned with the adjacent row nodes of the axially adjacent row of cells. In the unexpanded state, the cusp node 876 can be located proximal to the proximal end 850 of the column 846, but in the expanded state, the cusp node 876 is located distal to the proximal end 850 of the column 846, as shown. Figure 9 As shown. Furthermore, in Figure 10 In the undilated state shown, the cusp nodule 876 may be located proximal to the attachment feature 854. In some embodiments, the cusp nodule 876 may have a retrieval feature for recapture or repositioning the expandable frame 800, as the nodule 876 is positioned between the undilated and dilated states relative to the attachment feature 854 or the post 846.

[0089] Figure 11-13 and Figures 14A-14C Another embodiment of the expandable frame 1100 of the present invention is depicted. When the expandable frame 1100 is combined with a valve structure similar to that described above and as... Figures 14A-14C When used with the valve structure 1200 attached to the expandable frame 1100, the expandable frame can form a shorter supraannular valve prosthesis 1400. Figure 8-10 Similar to the expandable frame shown, expandable frame 1100 is primarily designed for valve structures (such as those to be installed near the inner surface of expandable frame 1100a) to be mounted. Figures 14A-14C (As shown in the special illustration). Figure 11 A perspective view of the expandable frame 1100 in its expanded state is shown. Figure 12 It shows the state of expansion. Figure 11 A schematic diagram of the support mode of the expandable frame 1100, and Figure 13 It shows the state of non-expansion. Figure 11 A schematic diagram of the support mode of the expandable frame 1100. Figures 14A-14C It shows attachment to Figure 11-13The valve structure 1200 of the expandable frame 1100 and the valve prosthesis 1400 shown are illustrated.

[0090] The expandable frame 1100 may have a proximal end 1102 and a distal end 1104 opposite to the proximal end 1104, with the axial length of the expandable frame spanning between the proximal end 1101 and the distal end 1104. The expandable frame 1100 may have an outer surface 1106 and an inner surface 1108, with a thickness between them. The inner surface 1108 defines an inner lumen 1110. The expandable frame 1100 may have an expandable region 1112 and a cusp region 1114 located proximal to the expandable region 1102. The expandable region 1112 has a proximal end 1116 and a distal end 1118. The expandable region 1112 includes a plurality of cells 1120 defining an opening 1121. In some embodiments, all cells 1120 of the expandable region 1112 may have substantially the same size and shape. In other embodiments, the cells 1120 of the expandable region 1112 have different sizes and shapes. The cells 1120 may be as described above for... Figure 8-10 The cells 820 in the illustrated embodiment are arranged as discussed.

[0091] The cusp valve region 1114 may have a proximal end 1142 and a distal end 1144. The cusp valve region 1114 includes a plurality of posts 1146 for attaching the valve structure to the expandable frame 1100. In some embodiments, the cusp valve region 1114 may have two posts 1146. In some embodiments, for example in… Figure 11 In the embodiment shown in -14, the cusp valve region 1114 may have three columns 1146. In other embodiments, the cusp valve region may have any number of columns 1146. Each column 1146 may have a proximal end 1148 and a distal end 1150, said proximal and distal ends extending from the proximal end 1142 to the distal end 1144 of the cusp valve region 1114. In some embodiments, the distal end 1150 of the column 1146 may be attached to the expandable region 1112 at the proximal end 1116, as described above for... Figure 8-10 As discussed in column 846 of the illustrated embodiment.

[0092] Each strut 1146 may include at least one strut 1152 and at least one attachment feature 1154 connected to the strut 1152. One end of the strut 1152 is attached to the expandable region 1112. The width of the strut 1152 may be greater than the width of the strut in the expandable region 1112. The at least one attachment feature 1154 may include a tab 1158 having at least one opening 1160 within it. In at least one embodiment, the opening 1160 may be a slot, while in other embodiments, the opening 1160 may be a hole. In yet another embodiment, the attachment feature 1154 may include a plurality of openings 1160 that facilitate a particular suture pattern, the openings including holes, slots, or slits. In other embodiments, the at least one attachment feature may include a hook. In some embodiments, the strut 1152 may have a recovery feature for recapture or repositioning the expandable frame 1100.

[0093] Each column 1146 defines at least a portion of at least one cusp region cell 1170. At least one cusp region cell 1170 may be associated with... Figure 8-10 The cusp region cell 870 of the illustrated embodiment is similarly defined. At least in Figure 11-13 In the illustrated embodiment, the cusp region cell is defined by eight struts: strut 1152 of column 1146, a pair of cusp struts 1174, a C-shaped strut 1180 with one end connected to one of the cusp struts 1144 and the other end connected to the end nodule 1134 of the expandable region 1112, and four adjacent struts 1130 of the first circumferential row cell 1122 at the proximal end 1116 of the expandable region 1112. Adjacent C-shaped struts 1180a and 1180b can be connected to the same end nodule 1134 of the expandable region. Adjacent C-shaped struts 1180a and 1180b can each be attached to struts 1174a and 1174b of the adjacent pair of struts, respectively. The connection of adjacent C-shaped struts 1180a and 1180b and struts 1174a and 1174b forms a nodule 1188. C-shaped struts 1180a and 1180b of adjacent cusp valve region cells 1170 form an opening 1192. The size and shape of the opening 1192 can be designed to allow access to the coronary artery for assisted procedures (e.g., atherosclerosis resection or angioplasty) without obstructing movement of the cusp valve or leaflets of the valve structure. In some embodiments, the size of the opening 1192 can be between 10 French (10 Fr) and 14 French (14 Fr), and in at least one embodiment, the size of the opening 1192 can be 12 French (12 Fr) to allow catheter insertion into the opening.

[0094] Figure 13An expandable frame 1100 in its unexpanded state is shown. In the unexpanded state, the cusp tubercle 1176 can be located proximally to the proximal end 1148 of the column 1146, but in the expanded state, the cusp tubercle 1146 is located distally to the proximal end 1148 of the column 1146, as shown. Figure 12 As shown. The cusp nodule 1176 can be radially aligned. (As...) Figure 13 As shown, the opening 1192 can be radially aligned in the unexpanded state. In some embodiments, adjacent nodules 1188 can be radially aligned in the unexpanded state.

[0095] Figures 14A-14C The attachment of a valve structure 1200 to an expandable frame 1100 according to at least one embodiment of a valve prosthesis 1400 is depicted. The valve structure 1200 can be attached to the frame as described in the disclosure of co-owned U.S. Application Serial No. 16 / 129235 entitled “Replacement Heart Valve with Reduced Sutures,” the entire contents of which are incorporated herein by reference. Furthermore, the valve structure 1200 can be attached to the expandable frame 1100 by overlapping some tissue onto a post 1146. In one embodiment, a slit 1206 can be formed in the valve structure 1200 near each commissural region 1202 and near the proximal end 1204 of the valve structure. Each post 1146 can be inserted through one slit 1206 of the valve structure 1200 such that the commissural region 1202 at least partially overlaps with the proximal end of the post 1146. The valve structure can then be attached to each post 1146 using an attachment feature 1154, using a suture. At least one running belly suture, using a single suture, can be used circumferentially around the frame to further attach the valve structure to the frame. In one embodiment, the running belly suture follows the pattern of the cusp of the valve structure. In some embodiments of the valve prosthesis 1400, a perivalvular leakage prevention skirt 1408 can be provided on the outer surface of the valve. The skirt can be attached circumferentially around the valve using another suture. In at least one embodiment, the valve prosthesis 1400 has fewer than six sutures. In some embodiments, the valve prosthesis has three to six sutures. In other embodiments, the valve prosthesis has three to five sutures.

[0096] Figure 15-17 Another embodiment of the expandable frame 1500 of the present invention is depicted. When the expandable frame 1500 is combined with the above-described and as... Figures 14A-14C When used with the valve structure 1200 attached to the expandable frame 1150, the expandable frame can form a shorter supraannular valve prosthesis. Figure 8-13 Similar to the expandable frame shown, the expandable frame 1500 is primarily designed for valve structures to be installed near the inner surface of the expandable frame.

[0097] The expandable frame 1500 may have a proximal end 1502 and a distal end 1504 opposite to the proximal end 1504, with the axial length of the expandable frame spanning between the proximal end 1501 and the distal end 1504. The expandable frame 1500 may have an outer surface 1506 and an inner surface 1508, with a thickness between them. The inner surface 1508 defines an inner lumen 1510. The expandable frame 1500 may have an expandable region 1512 and a cusp region 1514 located proximal to the expandable region 1512. The expandable region 1512 has a proximal end 1516 and a distal end 1518. The expandable region 1512 includes a plurality of cells 1520 defining an opening 1521. In some embodiments, all cells 1520 of the expandable region 1512 may have substantially the same size and shape. In other embodiments, the cells 1520 of the expandable region 1512 have different sizes and shapes. The cells 1520 may be as described above for... Figure 8-10 Cell 820 of the embodiment shown and Figure 11-13 The cells 1120 in the illustrated embodiment are arranged as discussed.

[0098] The cusp valve region 1514 may have a proximal end 1542 and a distal end 1544. The cusp valve region 1514 includes a plurality of posts 1546 for attaching the valve structure to the expandable frame 1500. In some embodiments, the cusp valve region 1514 may have two posts 1546. In some embodiments, for example in… Figure 15-17 In the illustrated embodiment, the cusp valve region 1514 may have three columns 1546. In yet another embodiment, the cusp valve region may have any number of columns 1546. Each column 1546 may have a proximal end 1548 and a distal end 1550, the proximal and distal ends extending from the proximal end 1542 to the distal end 1544 of the cusp valve region 1544. In some embodiments, the distal end 1550 of the column 1546 may be attached to the expandable region 1512 at the proximal end 1516, as described above for... Figure 8-10 The column 846 of the embodiment shown and Figure 11-13 As discussed in column 1146 of the illustrated embodiment.

[0099] Each strut 1546 may include at least one strut 1152 and at least one attachment feature 1154 connected to the strut 1152, as described above for... Figure 11-13 As discussed in the embodiment shown, the strut 1146. Figure 15-17 As shown, the at least one attachment feature can be different for a single post 1546 and its adjacent posts. Figure 15-17 As shown, at least one of the pillars 1546a may have an attachment feature 1548a, which includes a plurality of slits 1560 arranged in a pattern. Figure 15-17As shown, the plurality of slits 1560 form a lowercase "d" on one of the posts 1146, but the pattern can also form an uppercase "D" or any other suitable or desired configuration. The other posts 1546b and 1546c may have the same attachment features 1548b, 1548c, such as orifices or slots different from attachment feature 1548. Having a post 1546a with an attachment structure 1548a different from any of the attachment features 1548b, 1548c of any other post (or when the other posts have relatively consistent attachment features) can help physicians identify one of the commissural posts, facilitating valve alignment and orientation during delivery. In at least one embodiment, the first post 1546 may have a slit pattern, the second post 1546 may have at least one orifice, and the third post 1546 may have at least one slot, such that each post has an attachment feature different from its adjacent posts. This configuration can further assist physicians in aligning and orienting the valve during delivery.

[0100] Each column 1546 defines at least a portion of at least one cusp region cell 1570. The at least one cusp region cell 1570 may be similar to... Figure 8-10 Cell 870 of the cusp region in the embodiment shown and Figure 11-13 The cusp region cell 1170 of the illustrated embodiment is defined. At least in Figure 16 In the illustrated embodiment, the cusp region cell 1570 is defined by eight struts: strut 1552 of column 1546, a pair of cusp struts 1574, an axial strut 1580 with one end connected to one of the cusp struts 1564 and the other end connected to the end nodule 1534 of the expandable region 1512, and four adjacent struts 1530 of the first circumferential row cell 1522 at the proximal end 1516 of the expandable region 1512. In this embodiment, the axial strut 1580 includes at least one protrusion 1593. As shown, the axial strut 1580 has two protrusions 1593.

[0101] Figure 17 An expandable frame 1500 in its unexpanded state is shown. In the unexpanded state, the cusp tubercle 1576 can be located proximally to the proximal end 1550 of the column 1546, but in the expanded state, the cusp tubercle 1566 is located distally to the proximal end 1550 of the column 1546, as shown. Figure 16 As shown. The cusp nodule 1576 can be radially aligned.

[0102] Figure 18-20 Another embodiment of the expandable frame 1800 of the present invention is shown. When attached to a valve structure as described above, the expandable frame 1800 can form a shorter supraannular valve prosthesis. Figure 8-17Similar to the expandable frame shown, expandable frame 1800 is primarily designed for valve structures to be mounted near the inner surface of expandable frame 800. However, the valve structure can be mounted to the outer surface of this embodiment or any of the embodiments discussed herein.

[0103] The expandable frame 1800 may have a proximal end 1802 and a distal end 1804 opposite to the proximal end 1804, with the axial length of the expandable frame spanning between the proximal end 1801 and the distal end 1804. The expandable frame 1800 may have an outer surface 1806 and an inner surface 1808, with a thickness between them. The inner surface 1808 defines an inner lumen 1810. The expandable frame 1800 may have an expandable region 1812 and a cusp region 1814 located proximal to the expandable region 1812. The expandable region 1812 has a proximal end 1816 and a distal end 1818. The expandable region 1812 includes a plurality of cells 1820 defining an opening 1821. In some embodiments, all cells 1820 of the expandable region 1812 may have substantially the same size and shape. In other embodiments, the cells 1820 of the expandable region 1812 have different sizes and shapes. The cells 1820 may be as described above for... Figure 8-10 Cell 820 and the example shown Figure 11-13 The cells 1120 in the illustrated embodiment are arranged as discussed.

[0104] The cusp valve region 1814 may have a proximal end 1842 and a distal end 1844. The cusp valve region 1814 includes a plurality of posts 1846 for attaching the valve structure to the expandable frame 1800. In some embodiments, the cusp valve region 1814 may have two posts 1846. In some embodiments, for example in… Figure 18-20 In the illustrated embodiment, the cusp valve region 1814 may have three columns 1846. In yet another embodiment, the cusp valve region may have any number of columns 1846. Each column 1846 may have a proximal end 1848 and a distal end 1850, the proximal and distal ends extending from the proximal end 1842 of the cusp valve region 1854 to the distal end 1844. In some embodiments, the distal end 1850 of the column 1846 may be attached to the expandable region 1812 at the proximal end 1816, as described above for... Figure 8-10 The column 846 of the embodiment shown is Figure 11-13 As discussed in column 1146 of the illustrated embodiment.

[0105] Each strut 1846 may include at least one strut 1852 and at least one attachment feature 1854 connected to the strut 1852, as described above for... Figure 18-20 As discussed in the embodiment of strut 1846 shown, the at least one attachment feature may differ for one post 1846 and adjacent posts. (As described above regarding...) Figure 15-17As discussed in the illustrated embodiments, at least one of the posts 1846a may have an attachment feature 1848a comprising a plurality of slits 1860 in a pattern. In some embodiments, the plurality of slits 1860 form a lowercase “d” on one of the posts 1846, but the pattern may also form an uppercase “D” or any other suitable or desired configuration. The other posts 1846b and 1846c may have the same attachment features 1848b, 1848c, for example, holes or slots different from attachment feature 1848. In at least one embodiment, the first post 1846 may have a slit pattern, the second post 1846 may have at least one hole, and the third post 1846 may have at least one slot, such that each post has an attachment feature different from that of its neighbors. This configuration can help physicians align and orient the valve during delivery.

[0106] Each column 1846 defines at least a portion of at least one cusp region cell 1870. The at least one cusp region cell 1870 may be similar to... Figure 8-10 The cusp region cell 870 in the illustrated embodiment is used for definition. At least in Figure 19 In the illustrated embodiment, the cusp region cell 1870 is defined by nine struts: strut 1852 of column 1846, a pair of cusp struts 1874, a first meandering strut 1880, a second meandering strut 1881, and four adjacent struts 1830 of the first circumferential row cell 1822 located at the proximal end 1816 of the expandable region 1812. In one embodiment, the first meandering strut 1880 may be connected at a first end to one of the cusp struts 1874a of the cusp region cell 1870a and at a second end to the end nodule 1834 of the expandable region 1812. The second meandering strut 1881 may be connected at a first end to one of the cusp struts 1874b of the cusp region cell 1870b adjacent to the cusp region cell 1870a and at a second end to the end nodule 1834. In one embodiment, the second meandering strut 1881 may overlap with the first meandering strut 1880. The overlapping meandering struts 1880 and 1881 can form an "8" shape with two openings. The overlapping meandering struts 1880 and 1881 allow for improved stiffness in the cusp region 1814 and improved torsional resistance in that region.

[0107] Figure 20 An expandable frame 1800 in its unexpanded state is shown. This is in contrast to the one discussed in this paper. Figure 8-13 and Figure 15-17 The other embodiments discussed are similar; in the undilated state, the cusp tubercle 1876 can be located proximal to the proximal end 1850 of the column 1846, but in the dilated state, the cusp tubercle 187 is located distal to the proximal end 1850 of the column 1846, as... Figure 19As shown. The cusp nodule 1876 can be radially aligned.

[0108] In some embodiments, having Figure 18-20 The expandable frame valve prosthesis shown has a length of 1.33 cm. 2 up to 3.43cm 2 The average effective orifice area (EOA) between [amounts]. In some embodiments, the average EOA can be 1.68 cm². 2 up to 3.08cm 2 Between. In other embodiments, the average EOA can be between 2.03 cm. 2 up to 2.73cm 2 between.

[0109] The expandable frame discussed herein may further include one or more radiopaque markers for positioning the expandable frame, and thus the valve structure, at a desired location relative to the patient's natural anatomy during delivery procedures. In some embodiments of the expandable frame, including but not limited to at least... Figure 8-20 In the embodiments depicted, the expandable frame may have radiopaque markers attached to at least one strut. In some embodiments of the expandable frame, including but not limited to at least... Figure 8-20 In the embodiments depicted, the expandable frame may have a radiopaque marker attached to at least one nodule. In some embodiments, the radiopaque marker may be positioned on at least one strut or at least one nodule or a combination of at least one strut or nodule. In some embodiments, the radiopaque marker may be attached to at least one strut or at least one nodule or a combination of at least one strut or nodule. In some embodiments, the radiopaque marker may be a coating on that portion of the expandable frame. The position of the radiopaque marker can be determined by shortening the strut from its loaded state in the delivery catheter (which may be equivalent to or may not be equivalent to its unexpanded state) to its expanded state. In some embodiments, the position of the radiopaque marker can be determined by shortening the strut from its unexpanded state to its expanded state. In some embodiments, the radiopaque marker may be positioned in the distal row of the expandable region. In yet another embodiment, the radiopaque marker may be placed on at least one synaptic post or on a strut or nodule in the cusp region. In at least one embodiment, as Figure 21As shown, the expandable frame 2100 may have expandable cell regions 2112 and cell cusp regions 2114 located within the expandable region 2112. The cusp regions 2114 may define the outflow end of the expandable frame, while the expandable region 2112 may define the inflow end of the expandable frame. At least within the expandable region 2112, the expandable frame 2100 may have multiple rows 2116 of nodules 2118 connecting struts 2120 of adjacent cells in the expandable region 2122. Figure 21 As shown, the expandable region 2112 has nodules 2118 in five rows 2116a, 2116b, 2116c, 2116d, and 2116e. Row 2116a may define the proximal end 2124 of the expandable region 2112, and row 2116e may define the distal end 2126 of the expandable region 2112. In some embodiments, radiopaque markers may be positioned at one of the terminal rows 2116a, 2116e. More specifically, radiopaque markers may be positioned at or near the nodules of row 2116e to help physicians visualize the location of the distal end of the expandable frame during delivery. In other embodiments, radiopaque markers may be positioned at or near the nodules of row 2116a near the outflow end of the valve prosthesis to help physicians visualize the relative positions of the valve apex valves of the valve structure. In other embodiments, the radiopaque markers may be located in the intermediate rows 2116b, 2116c, 2116d of the nodules in the expandable region 2112. More specifically, as Figure 21 As shown, the radiopaque marker 2128 can be located on the strut 2120 between rows 2116c and 2116d. In some embodiments, the position of the radiopaque marker 2128 can be translated to a desired position of the expandable frame relative to the patient's natural valve annulus, such that it can be properly positioned on the valve annulus relative to the patient's natural valve annulus.

[0110] exist Figure 11-21 In any of the embodiments shown or in other similar embodiments, the valve structure can be attached to an expandable frame, reducing the number of sutures compared to other commercially available transcatheter aortic valve devices. Figure 22 It shows that at least in Figure 12The suture pattern on an expandable frame 2210 similar to the expandable frame shown in the figure. The expandable frame 2210 may have a proximal end 2212 and a distal end 2214 opposite to the proximal end 2214. The expandable frame may have a plurality of syndesmotic posts 2246 at or substantially near the proximal end 2212. Each syndesmotic post 2246 may have a proximal end 2248 and a distal end 2250. Each strut 2246 may include at least one strut 2252 and at least one attachment feature 2254 connected to or embedded in the strut 2252. The at least one attachment feature 2254 may include a tab 2258 having at least one opening 2260 therein. The expandable frame also includes cusp valve struts 2274 attached to both sides of the posts 2246. In embodiments where the valve structure is a one-piece valve structure, the attachment of the valve structure to the expandable frame 2210 may include a suture pattern 2200, such as Figure 22 As shown. Suture pattern 2200 includes three semicircles 2220, each semicircle 2220 corresponding to a leaflet of the valve structure. Each semicircle 2220 includes 10 to 45 sutures 2221. In some embodiments, each semicircle includes 20 to 30 sutures 2221. Suture pattern 2200 may include a suture 2222 having a first end 2223 and a second end 2225. In at least one embodiment, the first end 2223 and the second end 2225 are tied together to complete suture pattern 2200. In some embodiments, the first end 2223 and the second end 2225 may be tied at a strut of the frame. In other embodiments, the first end 2223 and the second end 2225 may be tied around one of the posts 2254. In some embodiments, suture pattern 2200 consists only of locking sutures.

[0111] according to Figure 23A and 23B The connecting columns of the expandable frame. Figure 23A An example of the suture pattern 2320 is shown from an advantageous position on the outer surface of the expandable frame 2210. Figure 23B A favorable position is shown from the inner surface of the expandable frame 2210. Figure 23AThe suture pattern 2320 includes a suture 2322. The synaptic post 2346 includes a proximal end 2348 and a distal end 2350. The synaptic post also includes an inner surface 2349 and an outer surface 2351. The synaptic post 2346 further includes a strut 2352 and an attachment feature 2354. The strut 2352 has a first side 2356 and a second side 2358. A cusp strut 2374 extends from both sides 2356, 2358 of the strut 2352. The attachment feature shown includes an opening 2360. In at least one embodiment, the synaptic suture pattern 2320 includes a suture 2322 having a first end 2380 and a second end 2381. The first end 2380 is disposed within the opening 2360 of the attachment feature 2354. Then, suture 2322 extends from the first end 2380 along the outer surface 2351 of the connecting post 2346 to the first side 2356 to position 2382. At position 2382, suture 2322 crosses the inner surface 2349 of the connecting post 2346 to the second side 2358 to position 2383. At position 2383, suture 2322 returns across the outer surface 2351 to the strut 2374 adjacent to the first side 2356, specifically reaching the top of the strut 2374 to position 2384. At position 2384, suture 2322 crosses the inner surface 2349 to the bottom of the strut 2374 adjacent to the second side 2358 to position 2385. At position 2385, suture 2322 crosses the outer surface 2351 toward the distal end of the connecting post 2346 at the first side 2358 to position 2386, then crosses the inner surface 2349 to position 2387. At position 2387, suture 2322 crosses the outer surface 2351 to the bottom of the strut 2374 adjacent to the first side 2356 to position 2388. At position 2388, suture 2322 crosses the inner surface 2349 to the top of the strut 2374 adjacent to the second side 2358 to position 2389. At position 2389, suture 2322 then crosses the outer surface 2351 to position 2389 between positions 2382 and 2384. Suture 2322 then crosses the inner surface 2389 through the opening 2360 to the second end 2381. The first end 2380 and the second end 2381 can be connected to each other via a fixing knot. In a preferred embodiment, when the valve structure is sutured to the commissural post, the valve structure is positioned close enough to the frame to ensure no post gaps and also to ensure that the valve structure can fully engage under pressure.

[0112] In some embodiments, in order to facilitate the above-described approach Figure 23A and 23B The valve structure is attached to the column as described above, and the valve structure can be modified to insert the column into a part of the valve structure. Figure 24An example is shown. Valve structure 2400 is a one-piece valve structure having leaflets 2402 and syndesmotic regions 2404 integrally molded between adjacent leaflets. Slits 2406 can be cut into valve structure 2400 at each syndesmotic region 2404, and syndesmotic posts of expandable frames can then be inserted into these slits such that once attached to the frame, a portion of valve structure 2400 lies on the outer surface of the expandable frame (and more specifically on the syndesmotic posts).

[0113] As used herein, the terms “substantially” or “largely” refer to the extent or degree of completeness or near-completeness of an action, characteristic, property, state, structure, item, or result. For example, a “substantially” or “largely” closed object means that the object is completely or nearly completely closed. In some cases, the exact permissible degree of deviation from absolute completeness may depend on the specific context. However, in general, a degree of near-completeness will make the overall result substantially the same as if absolute and overall completeness had been achieved. The use of “substantially” or “largely” also applies when used in a negative sense, referring to the complete or near-complete absence of an action, characteristic, property, state, structure, item, or result. For example, “substantially absent” or “largely absent” an element, combination, embodiment, or composition of a component or element may still actually contain such a substance, provided that there is substantially no measurable effect.

[0114] As used herein, any reference to "an embodiment" or "an embodiment" means that a particular element, feature, structure, or characteristic described in connection with that embodiment is included in at least one embodiment. The phrase "in an embodiment" appearing in different places in the specification does not necessarily refer to the same embodiment.

[0115] As used herein, the terms “comprising,” “including,” “containing,” “having,” “with,” or any other variation thereof are intended to cover non-exclusive inclusion. For example, a process, method, article, or apparatus that includes a list of elements is not necessarily limited to those elements, but may include other elements not expressly listed or inherent to the process, method, article, or apparatus. Furthermore, unless expressly stated otherwise, “or” means inclusive or, not exclusive or. For example, condition A or B satisfies any of the following: A is true (or exists), B is false (or does not exist); A is false (or does not exist), B is true (or exists); and both A and B are true (exist).

[0116] Additionally, the terms "a" or "an" are used to describe the elements and components in the embodiments described herein. This is done merely for convenience and to give a general meaning to the description. This specification should be understood to include one or at least one, and the singular includes the plural, unless it is obvious otherwise.

[0117] Furthermore, the accompanying drawings depict preferred embodiments for illustrative purposes only. Those skilled in the art will readily recognize from the discussion herein that alternative embodiments of the structures and methods shown herein may be employed without departing from the principles described herein.

[0118] While specific embodiments and applications have been shown and described, it should be understood that the disclosed embodiments are not limited to the precise constructions and components disclosed herein. Various modifications, alterations, and variations that will be apparent to those skilled in the art to the arrangement, operation, and details of the methods and apparatus disclosed herein may be made without departing from the spirit and scope defined in the appended claims.

[0119] While the systems and methods described herein have been described with reference to some exemplary embodiments, these embodiments are not limiting and are not necessarily mutually exclusive. It is conceivable that specific features of various embodiments may be omitted or combined for use with features of other embodiments while still falling within the scope of the invention.

Claims

1. A replacement heart valve for catheter-based repair of a natural heart valve, the replacement heart valve comprising: A frame having a distal end, a proximal end, and a length between the distal end and the proximal end, the frame further including an outer surface and an inner surface defining an inner cavity, the frame being capable of expanding from an unexpanded state to an expanded state, wherein the frame further includes: An expandable region defining the distal end of the frame and extending toward the proximal end of the frame, the expandable region having at least a first row of cells at the distal end of the expandable region, a second row of cells at the proximal end of the expandable region, and a plurality of intermediate rows of cells between the first row of cells and the second row of cells; and The cuspid valve region includes a plurality of valve columns extending proximally from the expandable region, each valve column including a valve attachment feature. The cuspid valve region has a plurality of cuspid valve region cells, each cuspid valve region cell being defined by at least one of the plurality of valve columns, a strut of a second row of cells at the proximal end of the expandable region, a first meandering strut, a second meandering strut, and a first cuspid valve strut. Wherein, the first meandering strut overlaps with the second meandering strut to define two openings forming an "8" shape; and A valve structure comprising at least two leaflets, wherein the valve structure is attached to the frame at valve attachment features of at least two valve columns.

2. The replacement heart valve according to claim 1, wherein, The valve structure is internally mounted to the frame such that the outer surface of the valve structure abuts against the inner surface of the frame.

3. The replacement heart valve according to claim 1, wherein, The valve structure comprises a single piece of biomaterial.

4. The replacement heart valve according to claim 3, wherein, There is a shaped fusion region between the at least two leaflets.

5. The replacement heart valve according to claim 4, wherein, The shaped fusion region of the valve structure is attached to the valve column of the frame.

6. The replacement heart valve according to claim 5, wherein, The valve structure further includes a plurality of slits, each slit being located at the forming fusion region of the valve structure, and each valve column being inserted into a slit before the valve structure is attached to the valve column.

7. The replacement heart valve according to claim 3, wherein, The biomaterials include polymers, bovine tissue, or porcine tissue.

8. The replacement heart valve according to claim 1, wherein, The valve column also includes fusion alignment markers.

9. The replacement heart valve according to claim 1, wherein, The valve structure has a diameter of 1.7 cm. 2 up to 3.5cm 2 The average effective orifice area between.

10. The replacement heart valve according to claim 1, wherein, The valve structure is attached to the frame at least at the valve attachment features of at least three valve columns.

11. The replacement heart valve according to claim 1, wherein, The first meandering strut has a first end and a second end, wherein the first end of the first meandering strut is connected to the first cusp strut, and the second end of the first meandering strut is connected to the end nodule of the expandable region.

12. The replacement heart valve according to claim 1, wherein, One of the valve attachment features includes multiple slits.

13. The replacement heart valve according to claim 12, wherein, The valve attachment characteristics on one valve column differ from those on circumferentially adjacent valve columns.

14. The replacement heart valve according to claim 1, wherein, All cells in the expandable region have the same size.

15. The replacement heart valve according to claim 1, wherein, The valve column includes at least one strut.

16. The replacement heart valve according to claim 15, wherein, Each cusp valve region cell is defined by nine struts.

17. The replacement heart valve according to claim 1, wherein, The valve structure has a diameter of 2.5 cm. 2 up to 3.5cm 2 The average effective orifice area, the pressure gradient between 4 mmHg and 7 mmHg, and the Doppler velocity index factor between 0.55 and 0.

70.

18. The replacement heart valve according to claim 1, wherein, Each valve column has a proximal end and a distal end, as well as a length between the proximal and distal ends of the valve column, wherein the length of the valve column is between 20% and 75% of the length of the frame.

19. The replacement heart valve according to claim 1, wherein, The circumferentially adjacent valve columns are positioned equidistantly from each other around the outer periphery of the frame.

20. The replacement heart valve according to claim 1, wherein, The frame has two valve columns.

21. The replacement heart valve according to claim 1, wherein, The frame has three valve columns.

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