Systems and methods for sizing and implanting a prosthetic heart valve - Patents.com

Abstract

To provide a method for selecting the size of a transcatheter heart valve for implantation in a patient. A method for implanting a prosthetic heart valve includes selecting a prosthetic heart valve, the prosthetic heart valve having a nominal diameter that is up to 40 percent larger than the native annulus diameter of the native valve annulus. The method further includes compressing the selected prosthetic heart valve into a radially collapsed configuration, in which the selected prosthetic heart valve has a first diameter that is smaller than the nominal diameter, positioning the selected prosthetic heart valve within the native valve annulus, and expanding the selected prosthetic heart valve from the radially collapsed configuration to a radially expanded configuration, in which the selected prosthetic heart valve has a second diameter that is up to 10 percent smaller than the nominal diameter and larger than the first diameter.

Description

[Technical Field]

[0001] The present disclosure relates to prosthetic heart valve embodiments and systems and methods relating to such prosthetic heart valve embodiments. [Background technology]

[0002] The human heart can be affected by a variety of valvular diseases. These valvular diseases can result in significant dysfunction of the heart and ultimately require replacement of the natural valve with a prosthetic valve. There are many known prosthetic valves and many known methods for implanting these prosthetic valves in humans.

[0003] A variety of surgical techniques are available for replacing or repairing valvular or damaged valves. Many patients with stenosis and other valvular heart diseases undergo surgery each year to replace their defective natural heart valves with prosthetic valves. Another, less invasive method for treating defective valves is through repair or reconstruction, which is typically utilized for valves with minimally advanced calcification. The problem with surgical therapy is that it poses significant risks to these chronically ill patients, with high morbidity and mortality rates associated with surgical repair.

[0004] When a native valve is replaced, surgical implantation of a prosthetic valve typically requires open-heart surgery, during which the heart is stopped and the patient is placed on cardiac bypass (known as "cardiopulmonary bypass"). In a common surgical procedure, the native valve leaflets containing the valvular disease are removed and the prosthetic valve is sutured to the surrounding tissue at the annulus. Due to the trauma associated with the procedure and the concomitant duration of extracorporeal circulation, some patients die before surviving the surgical procedure or die shortly thereafter. As is well known, the risks to the patient increase with the amount of time spent on extracorporeal circulation. Due to these risks, a significant number of patients with valvular diseased native valves are deemed inoperable because they are too frail to withstand the procedure. By some estimates, more than 50% of patients over the age of 80 with valvular stenosis are unable to undergo surgery to replace their valve.

[0005] Due to the drawbacks associated with traditional open-heart surgery, percutaneous and minimally invasive surgical approaches have attracted considerable attention. In one technique, prosthetic valves are configured to be implanted in a much less invasive procedure via catheterization. For example, U.S. Patent Nos. 5,411,522 and 6,730,118 describe compressible transcatheter heart valves that are percutaneously introduced onto a catheter in a compressed state and can be expanded at a desired location by balloon inflation or by the use of a self-expanding frame or stent.

[0006] A key design parameter of a transcatheter heart valve is the diameter of the folded or crimped profile. The diameter of the crimped profile is important because it directly affects how far a physician can advance the transcatheter heart valve through the femoral artery or vein. More specifically, a smaller profile allows for the treatment of a wider patient population with enhanced safety. Another important design parameter is the control of paravalvular regurgitation around the valve, which can occur over a period of time after initial implantation. [Prior art documents] [Patent documents]

[0007] [Patent Document 1] U.S. Patent No. 5,411,522 [Patent Document 2] U.S. Patent No. 6,730,118 [Patent Document 3] U.S. Patent Application Publication No. 2012 / 0239142 [Patent Document 4] U.S. Patent Application No. 62 / 513,348 [Patent Document 5] U.S. Patent Application Publication No. 2017 / 0065415 [Patent Document 6] U.S. Patent Application Publication No. 2014 / 0343670 Summary of the Invention [Problem to be solved by the invention]

[0008] Selecting the size of the transcatheter heart valve for implantation within the patient is yet another important consideration. [Means for solving the problem]

[0009] Described herein are embodiments of prosthetic heart valves that, among other things, have a small crimp profile, control paravalvular leakage, and are capable of implantation within a variety of native annulus sizes.

[0010] In one exemplary embodiment, a prosthetic heart valve includes a frame having an inflow end and an outflow end, the frame being radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration, the frame including a plurality of struts defining openings. The prosthetic heart valve may further include a valve structure mounted within the frame and including a plurality of leaflets for regulating blood flow through the frame, each leaflet including an inflow surface, an outflow surface, and a leaflet edge portion secured to the frame. The prosthetic heart valve may also include a sealing member mounted on the frame and including an inner layer and an outer layer. At least the outer layer is mounted on the exterior of the frame, the inner layer covering at least the openings in the frame between adjacent leaflet portions of adjacent leaflets, and the inner layer not covering one or more openings in the frame facing the outflow surfaces of the leaflets, thereby allowing retrograde blood to flow into a space between the outer layer and the frame through the one or more uncovered openings in the frame.

[0011] Additionally, systems and methods are described herein for sizing and deploying prosthetic heart valves that can, for example, improve the characteristics of blood flow ("hemodynamics") through a native valve or other area where the prosthetic heart valve is implanted.

[0012] In one exemplary embodiment, a method for selecting a prosthetic heart valve is provided, which may include determining a native annulus area of ​​a native heart valve by obtaining an image of the native annulus and measuring the image, determining which prosthetic heart valve among a plurality of prosthetic heart valves corresponds to the determined native annulus area, analyzing hemodynamic data for each prosthetic heart valve among the plurality of prosthetic heart valves, and selecting a desired prosthetic heart valve from the plurality of prosthetic heart valves based on the analyzed hemodynamic data.

[0013] In some embodiments, the hemodynamic data includes a pressure gradient across the prosthetic heart valve, which is the blood pressure at the outflow end of the prosthetic heart valve divided by the blood pressure at the inflow end of the prosthetic heart valve.

[0014] In some embodiments, the selected prosthetic heart valve has the lowest pressure gradient of the prosthetic heart valve corresponding to the determined native annulus area.

[0015] In some embodiments, the selected prosthetic heart valve has a maximum nominal diameter of the prosthetic heart valve that corresponds to the determined native annulus area.

[0016] In some embodiments, the selected prosthetic heart valve has a maximum expanded diameter of the prosthetic heart valve that corresponds to the determined native annulus area.

[0017] In some embodiments, the method further comprises determining a diameter of the native annulus, wherein the selected prosthetic heart valve has an expanded diameter that is smaller than the determined diameter of the native annulus.

[0018] In some embodiments, the expanded diameter is within the range of 0-10% less than the determined diameter of the native annulus.

[0019] In some embodiments, the expanded diameter is within the range of 0-5% less than the determined diameter of the native annulus.

[0020] In some embodiments, the method further comprises determining a diameter of the native annulus, wherein the selected prosthetic heart valve has an expanded diameter greater than the determined diameter of the native annulus.

[0021] In some embodiments, the expanded diameter is in the range of 0-40% greater than the determined diameter of the native annulus.

[0022] In some embodiments, the expanded diameter is within the range of 0-20% greater than the determined diameter of the native annulus.

[0023] In some embodiments, the prosthetic heart valve is balloon expandable.

[0024] In some embodiments, the method is executed as an application on a computing device.

[0025] In some embodiments, the method further comprises implanting the selected prosthetic heart valve within the native annulus.

[0026] In one exemplary embodiment, a method for selecting a prosthetic heart valve is provided. The method may include determining a diameter of a native heart valve annulus and advancing the prosthetic heart valve through a patient's blood vessel to the native heart valve annulus. The prosthetic heart valve is in a radially collapsed configuration. The prosthetic heart valve includes a frame having an inflow end and an outflow end, the frame being radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration, and a valve structure mounted within the frame and including a plurality of leaflets for regulating blood flow through the frame. Each leaflet includes opposing upper tabs on either side of the leaflet, opposing lower tabs on either side of the leaflet located below the upper tabs, and a leaflet edge portion extending between the lower tabs, the leaflet edge portion being fixed to the frame. Each upper tab mates with an adjacent upper tab of an adjacent leaflet to form a plurality of commissures fixed to the frame, and each lower tab is folded to form at least one folded layer along the leaflet edge portion of the respective leaflet. The method further includes expanding the prosthetic heart valve from the radially collapsed configuration to a radially expanded configuration, wherein in the radially expanded configuration, the prosthetic heart valve has an outer diameter that is greater than the determined diameter of the native heart valve annulus.

[0027] In some embodiments, the outer diameter of the prosthetic heart valve in the radially expanded configuration is in the range of 5-40% greater than the determined diameter of the native heart valve annulus.

[0028] In some embodiments, the outer diameter of the prosthetic heart valve in the radially expanded configuration is in the range of 10-20% greater than the determined diameter of the prosthetic heart valve annulus.

[0029] In some embodiments, the outer diameter of the prosthetic heart valve in the radially expanded configuration is less than the nominal diameter of the prosthetic heart valve.

[0030] In another exemplary embodiment, a method for implanting a prosthetic heart valve is provided. The method includes determining a native annulus area and a native annulus diameter of the native heart valve by acquiring an image of the native annulus of the native heart valve, obtaining measurements of the native annulus from the image, and calculating the area and diameter of the native annulus based on the measurements; determining which prosthetic heart valve among a plurality of prosthetic heart valves corresponds to the determined native annulus area; analyzing hemodynamic data for each prosthetic heart valve among the plurality of prosthetic heart valves; selecting a prosthetic heart valve among the plurality of prosthetic heart valves based on the analyzed hemodynamic data, the selected prosthetic heart valve having a nominal diameter that is up to 40 percent larger than the determined native annulus diameter; compressing the selected prosthetic heart valve into a radially collapsed configuration, wherein the selected prosthetic heart valve has a first diameter that is less than the nominal diameter; positioning the selected prosthetic heart valve within the native annulus; and expanding the selected prosthetic heart valve from the radially collapsed configuration to a radially expanded configuration, wherein the prosthetic heart valve has a second diameter that is up to 10 percent smaller than the nominal diameter and larger than the first diameter.

[0031] In some embodiments, the images are obtained using computed tomography.

[0032] In yet another representative embodiment, one or more computer-readable storage media comprising instructions executable by a computer are provided, the instructions being configured to receive user-input native heart valve annulus area measurements, calculate an area-derived native heart valve annulus diameter based on the received native heart valve annulus area measurements, analyze hemodynamic characteristics of a plurality of prosthetic heart valves, determine a proposed prosthetic heart valve from among the plurality of prosthetic heart valves, determine a proposed diastolic diameter of the proposed prosthetic heart valve, and determine an expected pressure gradient between the proposed prosthetic heart valves.

[0033] The various innovations of this disclosure may be utilized in combination or separately. This Summary is provided to introduce in a simplified form a collection of concepts that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of these innovations will become more apparent by reference to other portions of this disclosure, including the Detailed Description, drawings, and claims. [Brief explanation of the drawings]

[0034] [Figure 1A] FIG. 1 is a perspective view of a prosthetic heart valve according to one embodiment. [Figure 1B] FIG. 1 is a perspective view of a prosthetic heart valve according to one embodiment. [Figure 1C] FIG. 2 is an enlarged perspective view of the lower region of one of the commissures of the prosthetic heart valve of FIGS. 1A and 1B. [Figure 2] FIG. 2 is a side elevational view of a sealing member of the prosthetic heart valve of FIG. 1. [Figure 3] FIG. 2 is a perspective cross-sectional view of the sealing member of FIG. [Figure 4] 2 is a cross-sectional view of the prosthetic heart valve of FIG. 1 showing retrograde blood flow through the valve. [Figure 5] FIG. 2 is an enlarged perspective view showing a portion of the interior of the prosthetic heart valve of FIG. 1. [Figure 6] 4A-4C show fibrous strips that can be used to form a sealing member such as the sealing member of FIG. 3. [Figure 7A] 1 is a perspective view of an exemplary tubular body that may be used to form a sealing member for a prosthetic heart valve. FIG. [Figure 7B] 1 is a perspective view of an exemplary tubular body that may be used to form a sealing member for a prosthetic heart valve. FIG. [Figure 8] FIG. 1 is a perspective view of a partially assembled prosthetic heart valve showing leaflet attachment using a connecting skirt according to one embodiment. [Figure 9] FIG. 9 is a plan view of the leaflets and connecting skirt used in the prosthetic heart valve of FIG. 8. [Figure 10] FIG. 10 is a view showing the attachment of the connecting skirt and leaflets of FIG. 9. [Figure 10A] FIG. 10 is a view showing the attachment of the connecting skirt and leaflets of FIG. 9. [Figure 11A] FIG. 10 is a view showing the attachment of the connecting skirt and leaflets of FIG. 9. [Figure 11B] FIG. 10 is a view showing the attachment of the connecting skirt and leaflets of FIG. 9. [Figure 12] 10 is a diagram illustrating the connection of the connecting skirt of FIG. 9 to the frame of the prosthetic valve of FIG. 8. FIG. [Figure 12A] 10 is a diagram illustrating the connection of the connecting skirt of FIG. 9 to the frame of the prosthetic valve of FIG. 8. FIG. [Figure 12B] 10 is a diagram illustrating the connection of the connecting skirt of FIG. 9 to the frame of the prosthetic valve of FIG. 8. FIG. [Figure 13A] FIG. 1 is a perspective view of a frame of a prosthetic heart valve and leaflets mounted within the frame, according to one embodiment. [Figure 13B] FIG. 13B is an enlarged view of a portion of the frame and one of the leaflets of FIG. 13A. [Figure 14] FIG. 1 is a plan view of a valve leaflet that can be used in a prosthetic heart valve according to one embodiment. [Figure 15A] 10A-10C illustrate one method of connecting leaflet edge portions of a valve leaflet to the frame of a prosthetic heart valve using a connecting skirt. [Figure 15B] 10A-10C illustrate one method of connecting leaflet edge portions of a valve leaflet to the frame of a prosthetic heart valve using a connecting skirt. [Figure 15C] 10A-10C illustrate one method of connecting leaflet edge portions of a valve leaflet to the frame of a prosthetic heart valve using a connecting skirt. [Figure 15D] 10A-10C illustrate one method of connecting leaflet edge portions of a valve leaflet to the frame of a prosthetic heart valve using a connecting skirt. [Figure 16]10A-10C illustrate one method of connecting leaflet edge portions of a valve leaflet to the frame of a prosthetic heart valve using a connecting skirt. [Figure 17] 10A-10C illustrate one method of connecting leaflet edge portions of a valve leaflet to the frame of a prosthetic heart valve using a connecting skirt. [Figure 18] 10A-10C illustrate one method of connecting leaflet edge portions of a valve leaflet to the frame of a prosthetic heart valve using a connecting skirt. [Figure 19] 10A-10C illustrate one method of connecting leaflet edge portions of a valve leaflet to the frame of a prosthetic heart valve using a connecting skirt. [Figure 20] 10A-10C illustrate one method of connecting leaflet edge portions of a valve leaflet to the frame of a prosthetic heart valve using a connecting skirt. [Figure 21] 10A-10C illustrate one method of connecting leaflet edge portions of a valve leaflet to the frame of a prosthetic heart valve using a connecting skirt. [Figure 22] 10A-10C illustrate one method of connecting leaflet edge portions of a valve leaflet to the frame of a prosthetic heart valve using a connecting skirt. [Figure 23] 10A-10C illustrate one method of connecting leaflet edge portions of a valve leaflet to the frame of a prosthetic heart valve using a connecting skirt. [Figure 24] 10 is an enlarged perspective view of the interior of the prosthetic heart valve, showing another method of connecting the leaflet edge portions of the leaflets to the frame of the valve. FIG. [Figure 25A] 10A-10C show an alternative method of connecting leaflet edge portions of the leaflets to the frame of the prosthetic heart valve using a connecting skirt. [Figure 25B] 10A-10C show an alternative method of connecting leaflet edge portions of the leaflets to the frame of the prosthetic heart valve using a connecting skirt. [Figure 26] 10A-10C show an alternative method of connecting leaflet edge portions of the leaflets to the frame of the prosthetic heart valve using a connecting skirt. [Figure 27]10A-10C show an alternative method of connecting leaflet edge portions of the leaflets to the frame of the prosthetic heart valve using a connecting skirt. [Figure 28] 10A-10C show an alternative method of connecting leaflet edge portions of the leaflets to the frame of the prosthetic heart valve using a connecting skirt. [Figure 29] 10A-10C show an alternative method of connecting leaflet edge portions of the leaflets to the frame of the prosthetic heart valve using a connecting skirt. [Figure 30] 10A-10C show an alternative method of connecting leaflet edge portions of the leaflets to the frame of the prosthetic heart valve using a connecting skirt. [Figure 31] 10A-10C show an alternative method of connecting leaflet edge portions of the leaflets to the frame of the prosthetic heart valve using a connecting skirt. [Figure 32] 10A-10C show an alternative method of connecting the leaflet edge portions of the leaflets to the frame of the prosthetic heart valve without using a connecting skirt. [Figure 33] FIG. 1 is a plan view of a valve leaflet that may be used in a prosthetic heart valve according to one embodiment. [Figure 34] 34A-34D illustrate the formation of one half of a commissure using the leaflets of FIG. 33 according to one embodiment. [Figure 35] 34A-34D illustrate the formation of one half of a commissure using the leaflets of FIG. 33 according to one embodiment. [Figure 36] 34A-34D illustrate the formation of one half of a commissure using the leaflets of FIG. 33 according to one embodiment. [Figure 37] FIG. 34 is a cross-sectional view of a commissure formed from two leaflets of the type shown in FIG. 33 according to one embodiment. [Figure 38] FIG. 34 is a cross-sectional view of a commissure formed from two leaflets of the type shown in FIG. 33 according to another embodiment. [Figure 39] FIG. 1 is a plan view of a valve leaflet that may be used in a prosthetic heart valve according to another embodiment. [Figure 40] FIG. 1 is a plan view of a valve leaflet that may be used in a prosthetic heart valve according to another embodiment. [Figure 41]41A-41D illustrate the formation of a commissure from two leaflets of the type shown in FIG. 40 according to one embodiment. [Figure 42] 41A-41D illustrate the formation of a commissure from two leaflets of the type shown in FIG. 40 according to one embodiment. [Figure 43] 41A-41D illustrate the formation of a commissure from two leaflets of the type shown in FIG. 40 according to one embodiment. [Figure 44] 41A-41D illustrate the formation of a commissure from two leaflets of the type shown in FIG. 40 according to one embodiment. [Figure 45] 41A-41D illustrate the formation of a commissure from two leaflets of the type shown in FIG. 40 according to one embodiment. [Figure 46] FIG. 41 is a cross-sectional view of a commissure formed from two leaflets of the type shown in FIG. 40 according to one embodiment. [Figure 47] FIG. 34 is a cross-sectional view of a commissure formed from two leaflets of the type shown in FIG. 33 according to another embodiment. [Figure 48] FIG. 41 is a cross-sectional view of a commissure formed from two leaflets of the type shown in FIG. 40 according to another embodiment. [Figure 49] FIG. 1 is a plan view of a valve leaflet that may be used in a prosthetic heart valve according to another embodiment. [Figure 50] FIG. 50 is a cross-sectional view of one embodiment of a commissure formed from two leaflets of the type shown in FIG. 49. [Figure 51] FIG. 50 is a cross-sectional view of one embodiment of a commissure formed from two leaflets of the type shown in FIG. 49. [Figure 52] 52 shows the attachment of the commissures of FIG. 50 or 51 to the frame of a prosthetic heart valve using commissure attachment members. [Figure 53] 52 shows the attachment of the commissures of FIG. 50 or 51 to the frame of a prosthetic heart valve using commissure attachment members. [Figure 54] 52 shows the attachment of the commissures of FIG. 50 or 51 to the frame of a prosthetic heart valve using commissure attachment members. [Figure 55]52 shows the attachment of the commissures of FIG. 50 or 51 to the frame of a prosthetic heart valve using commissure attachment members. [Figure 56] FIG. 34 is a cross-sectional view of another embodiment of a commissure formed from two leaflets of the type shown in FIG. 33. [Figure 57] FIG. 1 is a side elevational view of a prosthetic heart valve according to another embodiment. [Figure 58] FIG. 1 is a perspective view of a prosthetic heart valve according to another embodiment. [Figure 59] FIG. 59 is a plan view of the sealing member of the prosthetic heart valve of FIGS. 57-58, shown in a flattened configuration. [Figure 60] FIG. 1 is a perspective view of a prosthetic heart valve according to another embodiment. [Figure 61] FIG. 1 is a cross-sectional view of a prosthetic heart valve according to another embodiment. [Figure 62] 62 shows the sealing member of the prosthetic heart valve of FIGS. 60-61 mounted on the frame of the valve. FIG. [Figure 63] 62 shows the sealing member of the prosthetic heart valve of FIGS. 60-61 mounted on the frame of the valve. FIG. [Figure 64] 62 shows the sealing member of the prosthetic heart valve of FIGS. 60-61 mounted on the frame of the valve. FIG. [Figure 65] FIG. 1 is a perspective view of a prosthetic heart valve according to another embodiment. [Figure 66] FIG. 1 is a perspective view of a prosthetic heart valve according to another embodiment. [Figure 67] FIG. 67 is a perspective view of a portion of the prosthetic heart valve of FIGS. 65-66. [Figure 68] FIG. 67 is a perspective view of a sealing member of the artificial heart valve of FIGS. 65-66. [Figure 69] 10 is a cross-sectional view illustrating attachment of leaflet edge portions of a leaflet to a connecting skirt according to another embodiment. [Figure 70] FIG. 10 is a plan view of one embodiment of a connecting skirt for connecting leaflet edge portions of a leaflet to a frame, shown in a flattened configuration. [Figure 71] FIG. 67 is a side elevational view of the frame of the prosthetic heart valve of FIGS. 65-66. [Figure 72] 72A-72D illustrate the installation of a valve assembly within the frame of FIG. 71 according to one embodiment. [Figure 73] FIG. 73 is an enlarged view of a portion of the frame and valve assembly of FIG. 72. [Figure 74] FIG. 67 is a perspective view of the valve leaflets of the artificial heart valve of FIGS. 65 and 66. [Figure 75A] FIG. 75 is a plan view of the leaflets of FIG. 74 shown in a flattened configuration. [Figure 75B] 75 is a plan view of the leaflet of FIG. 74 and the connecting skirt of FIG. 70 positioned along the leaflet edge portion of the leaflet. [Figure 76] FIG. 10 is a plan view of one embodiment of a commissure mounting member shown in a flattened configuration. [Figure 77] FIG. 67 is a perspective view of one of the commissures of the prosthetic heart valve of FIGS. 65-66. [Figure 78] FIG. 67 is a cross-sectional view of one of the commissures of the prosthetic heart valve of FIGS. 65-66. [Figure 79] FIG. 1 is a perspective view of a prosthetic heart valve according to another embodiment. [Figure 80] FIG. 1 is a plan view of a prosthetic heart valve according to another embodiment. [Figure 81] FIG. 1 is a perspective view of a prosthetic heart valve according to another embodiment. [Figure 82] FIG. 1 is a plan view of a prosthetic heart valve according to another embodiment. [Figure 83] FIG. 1 is a perspective view of a prosthetic heart valve according to another embodiment. [Figure 84] FIG. 1 is a perspective view of a prosthetic heart valve according to another embodiment. [Figure 85] FIG. 85 is a side view of one of the commissures of the artificial valve of FIGS. 83-84. [Figure 86] FIG. 85 is a plan view of one of the commissures of the artificial valve of FIGS. 83-84. [Figure 87] 1 is a flow chart of an example method that may be used to select a prosthetic heart valve size. [Figure 88] 10 is a flow diagram of another example method that may be utilized to select a prosthetic heart valve size. [Figure 89]FIG. 1 is a schematic diagram illustrating a graphical user interface displayed on a display of a software application utilizing the methods disclosed herein. [Figure 90] FIG. 10 is a schematic diagram illustrating another display of a graphical user interface of a software application utilizing the methods disclosed herein. [Figure 91] FIG. 10 is a schematic diagram illustrating another display of a graphical user interface of a software application utilizing the methods disclosed herein. [Figure 92] FIG. 10 is a schematic diagram illustrating another display of a graphical user interface of a software application utilizing the methods disclosed herein. [Figure 93] FIG. 1 is a schematic diagram of an example computing system for implementing the disclosed techniques. [Figure 94] FIG. 1 is a schematic diagram of an example mobile device for implementing the disclosed techniques. DETAILED DESCRIPTION OF THE INVENTION

[0035] General considerations For purposes of description, certain aspects, advantages, and novel features of embodiments of the present disclosure are described herein. The methods, apparatus, and systems of the present disclosure should not be construed as limiting in any way. Rather, the present disclosure is directed to all novel and non-obvious features and aspects of the various embodiments of the present disclosure, both alone and in various mutual combinations and subcombinations. These methods, apparatus, and systems are not limited to any particular aspect, feature, or combination thereof, nor are embodiments of the present disclosure required to have any particular advantage or problems.

[0036] Although some operations of embodiments of the present disclosure are described in a particular sequential order for convenience of presentation, it should be understood that this description style encompasses rearrangements unless a particular order is required by specific wording below. For example, in some examples, operations described sequentially may be rearranged or performed simultaneously. Moreover, for purposes of simplicity, the accompanying drawings may not show the various ways in which methods of the present disclosure may be utilized in combination with other methods. Furthermore, the present description sometimes uses terms such as "implement" or "achieve" to describe methods of the present disclosure. These terms are highly abstract of the actual operations that are performed. The actual operations corresponding to these terms may vary depending on the particular implementation and may be readily recognized by those skilled in the art.

[0037] In this application and claims, the singular forms "a," "an," and "the" include the plural unless the context clearly dictates otherwise. Furthermore, the term "comprises" means "comprising." Furthermore, the term "coupled" generally means physically, mechanically, chemically, magnetically, and / or electrically coupled or linked, and does not exclude the presence of intermediate elements between coupled or associated items, unless specifically stated to the contrary.

[0038] As used herein, the term "proximal" refers to a position, orientation, or portion of a device that is located closer to the user and further from the implantation site. As used herein, the term "distal" refers to a position, orientation, or portion of a device that is located further from the user and closer to the implantation site. Thus, for example, proximal movement of a device is movement of the device away from the implantation site and toward the user (e.g., outside the patient's body), and distal movement of a device is movement of the device away from the user and toward the implantation site (e.g., into the patient's body). The terms "longitudinal" and "axial," unless otherwise specified, generally refer to axes extending in proximal and distal directions.

[0039] Example Embodiments of Prosthetic Heart Valves The present disclosure relates to embodiments of implantable prosthetic devices, particularly implantable prosthetic valves, and methods for making such devices. In certain embodiments, the prosthetic device comprises a prosthetic heart valve and can be configured to be implanted in any of the native heart valves (aortic, mitral, pulmonary, and tricuspid). Furthermore, the prosthetic heart valve can be, for example, a transcatheter heart valve, a surgical heart valve, or a minimally invasive heart valve. The prosthetic valve can also comprise other types of valves that can be implanted in other body cavities outside the heart, or heart valves that can be implanted in the heart at locations other than the native valve, such as a transatrial or transventricular septal valve.

[0040] The disclosed prosthetic heart valve is particularly suitable for implantation within a native aortic valve. In the context of a prosthetic aortic valve, the terms "inferior" and "upper" are used interchangeably with the terms "inflow" and "outflow," respectively, for convenience. Thus, for example, in the orientation shown in the drawings, the inferior end of the prosthetic valve is the inflow end of the prosthetic valve, and the superior end of the prosthetic valve is the outflow end of the prosthetic valve. However, it should be understood that the prosthetic valve can be implanted in the reverse orientation. For example, in the case of implantation in the mitral valve position, the superior end of the prosthetic valve is the inflow end, and the inferior end of the valve is the outflow end.

[0041] Figure 1A is a perspective view of a prosthetic heart valve 10 according to one embodiment. The illustrated valve is configured for implantation within the native aortic valve annulus, but in other embodiments, may be configured for implantation within other native valve annulus of the heart. Valve 10 may have three main components: a stent or frame 12, a valve structure 14, and a sealing member 16. Figure 1B is a perspective view of prosthetic valve 10 with components (including sealing member 16) shown in phantom on the exterior of frame 12 for illustrative purposes.

[0042] The valve structure 14 may include three leaflets 20 collectively forming a valve leaflet structure that may be configured to collapse in a tricuspid valve configuration, although in other embodiments, there may be more or fewer leaflets (e.g., one or more leaflets 20). Desirably, the lower edge of the valve leaflet structure 14 has a wavy, curved, fan-shaped portion. Forming the leaflets in this fan-shaped configuration reduces stress on the leaflets, further improving valve durability. Furthermore, the fan-shaped portion may eliminate or at least minimize folds and waves in the abdomen (the central region of each leaflet) of each leaflet, which can lead to premature calcification in these areas. The fan-shaped portion also reduces the amount of tissue material used to form the valve leaflet structure, thereby providing a smaller, more uniform crimped profile at the inflow end of the valve. The valve leaflets 20 may be formed from pericardial tissue (e.g., bovine or porcine pericardial tissue), a biocompatible synthetic material, or a variety of other suitable natural or synthetic materials as known in the art and as described in U.S. Pat. No. 6,730,118.

[0043] As will be further described below, each leaflet 20 may be coupled to the frame 12 along its inflow edge 30 (also referred to as the lower edge, or "leaflet edge," in the drawings) and at a commissure 32 of the valve structure 14 where adjacent portions of the two leaflets are interconnected.

[0044] Frame 12 may be made from any of a variety of suitable plastically expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., nitinol), as known in the art. If constructed from a plastically expandable material, frame 12 (and thus prosthetic valve 10) may be crimped into a radially compressed state onto a delivery catheter and then expanded inside the patient by an inflatable balloon or any suitable expansion mechanism. If constructed from a self-expanding material, frame 12 (and thus prosthetic valve 10) may be crimped into a radially compressed state and held in the compressed state by insertion into a sheath or equivalent mechanism of the delivery catheter. Once in place in the body, the prosthetic valve may be advanced from the delivery sheath, allowing the valve to expand to its functional size.

[0045] Suitable plastically expandable materials that can be used to form the frame 12 include, but are not limited to, stainless steel, nickel-based alloys (e.g., cobalt-chromium alloys or nickel-cobalt-chromium alloys), polymers, or combinations thereof. In certain embodiments, the frame 12 is made from a nickel-cobalt-chromium-molybdenum alloy, such as MP35N™ (a trademark of SPS Technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N™ / UNS R30035 contains 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum by weight. The use of MP35N to form the frame 12 has been found to provide superior structural results over stainless steel. Notably, when MP35N is used as the frame material, less material is required to achieve the same or better performance in radial crush force resistance, fatigue resistance, and corrosion resistance. Additionally, because less material is required, the crimped profile of the frame can be reduced, thereby providing a lower profile valve assembly for percutaneous delivery to a treatment location within the body.

[0046] The frame 12 in the illustrated embodiment includes a plurality of circumferentially extending rows of angled struts 22 that define rows of frame cells or openings 24. The frame 12 may have a cylindrical or substantially cylindrical shape with a constant diameter from the inflow end 26 to the outflow end 28 of the frame as shown, or the frame may have a varying diameter along the height of the frame as disclosed in U.S. Patent Application Publication No. 2012 / 0239142.

[0047] The sealing member 16 in the illustrated embodiment is attached to the exterior of the frame 12 and functions to form a seal against surrounding tissue (e.g., the native valve leaflets and / or annulus) to prevent or at least minimize paravalvular reflux. The sealing member 16 may include an inner layer 34 (which may be in contact with the outer surface of the frame 12) and an outer layer 36. The sealing member 16 may be coupled to the frame 12 using any suitable technique or mechanism. For example, the sealing member 16 may be sutured to the frame 12 with sutures 38 that may extend around the struts 22 and through the inner layer 34. In an alternative embodiment, the inner layer 34 may be attached to the inner surface of the frame 12, while the outer layer 36 is located on the exterior of the frame.

[0048] The outer layer 36 may be configured or shaped to extend radially outward from the inner layer 34 and frame 12 when the prosthetic valve 10 is deployed. As best shown in Figure 3, when the prosthetic valve is fully expanded outside the patient's body, the outer layer 36 may expand away from the inner layer 34 to form a space 40 between the two layers, thereby allowing the outer layer 36 to expand into contact with surrounding tissue when implanted within the body.

[0049] In the illustrated embodiment, the outer layer 36 includes a lower tapered wall section 36a extending outward from the frame in a direction from the inlet end to the outlet end, an upper tapered wall section 36b extending outward from the frame in a direction from the outlet end to the inlet end, and a central wall section 36c extending between the lower and upper tapered wall sections. The central wall section 36c may extend parallel to the longitudinal axis of the prosthetic valve as shown. In alternative embodiments, the upper and lower wall sections may extend perpendicular to the longitudinal axis of the prosthetic valve. In alternative embodiments, the outer layer 36 may be formed by connecting separate fabric components (e.g., separate pieces of material for each wall section 36a, 36b, 36c) together (e.g., with sutures) to form a three-dimensional structure without shape fixation.

[0050] The inner layer 34 is desirably formed with at least one hole or opening, and more desirably with multiple holes or openings 42 ( FIG. 5 ). As best shown in FIG. 4 , retrograde blood (indicated by arrows 44) can flow along the exterior of the valve leaflets 20, through the frame cells 24, through the openings 42 in the inner layer 34, and into the space 40 between the inner layer 34 and the outer layer 36, aiding in the expansion of the sealing member 16 and the formation of a seal against the surrounding tissue. In some embodiments, the outer layer 36 can be formed with multiple holes or openings that can allow blood to enter the sealing member at least during valve deployment.

[0051] In the illustrated embodiment, the inner layer 34 is formed with one or more openings 42 along the portion of the inner layer facing the outflow surface 70 of the leaflet (the area of ​​the frame between the commissures), thereby allowing retrograde blood to flow through the frame at those locations. The portions of the inner layer 34 covering the frame in the areas between the leaflet edge portions of the leaflets completely cover the openings in the frame at those locations, thereby preventing antegrade blood from flowing through the frame at those locations. In an alternative embodiment, the inner layer may have portions that cover the area of ​​the frame between the leaflet edge portions of the frame and the cutout section along the portion of the frame facing the outflow surface of the leaflet (see sealing members 702, 802, described below).

[0052] As shown in FIG. 5, the openings 42 can be centered at the intersections 50 of the frame struts 22, thereby preventing the material of the inner layer 34 surrounding these openings from protruding inward through the frame and contacting the valve leaflets.

[0053] The sealing member 16 may be formed from fibrous or non-fibrous materials, such as PET, PTFE, ePTFE, polyurethane, silicone, polyester, wire mesh, natural tissue (e.g., pericardium), and / or other suitable materials configured to restrict and / or prevent the passage of blood flow. In some embodiments, the sealing member may be formed from a generally flat strip that is folded lengthwise to form inner and outer layers and then formed into a tube, such as by welding or stitching the ends together. In other embodiments, the sealing member 16 may be formed by weaving, knitting, or braiding the sealing member into a tubular shape. Bulges in the outer layer 36 may be formed, for example, by shape-setting the material into a desired configuration (e.g., as shown in FIGS. 1 and 2). Shape-setting the outer layer may allow the outer layer to be self-expanding or to induce radial expansion of the outer layer. Additionally or alternatively, the outer layer 36 may be self-expanding by including nitinol threads in the outer layer.

[0054] In alternative embodiments, the inner layer 34 may be formed from a porous material that does not have openings 42 and allows blood to flow through the inner layer. For example, in some embodiments, the inner layer 34 may be formed from a relatively more porous material than the outer layer 36. In further alternative embodiments, the outer layer 36 need not be configured to extend away from the outer surface of the frame, but instead may have a shape that conforms to the outer surface of the frame. For example, the outer layer 36 may be generally tubular to correspond to the shape of the frame 12. In some embodiments, the outer layer may be formed from a fabric (e.g., a velour fabric) having a pile layer with fibers or yarns that form a looped or cut pile that aids in sealing against surrounding tissue. Sealing members formed from such fabrics are further described in U.S. Patent Application No. 62 / 513,348, filed May 31, 2017.

[0055] FIG. 6 illustrates a fabric strip that can be used to form the sealing member 16 according to one embodiment. As shown, the fabric strip can include a central section 52 and first and second longitudinal edge portions 54, 56 extending along opposite sides of the central section 52. The central section 52 can include one or more sets of openings 42 (e.g., three openings in each set in the illustrated embodiment). The openings 42 are positioned to coincide with the locations of the lower intersections 50 of the commissures of the prosthetic valve. The first and second longitudinal edge portions 54, 56 can be folded over the central portion 52 and secured to one another by stitching or the like to form the sealing member. The longitudinal edge portions 54, 56 collectively form the outer layer 36, and the central portion 52 forms the inner layer 34.

[0056] 7A and 7B are perspective views of exemplary tubular bodies that may be used to form sealing member 16. Referring to FIG. 7A, tubular body 80 may include upper and lower portions 82 and 84. Upper portion 82 may include a radial bulge 86. Tubular body 80 may be formed, for example, by three-dimensional weaving, knitting, or braiding. Lower portion 84 may be folded or bent into upper portion 82 to form a sealing member having an outer layer formed by upper portion 82 and an inner layer formed by lower portion 84.

[0057] 7B, tubular body 90 may include a cylindrical central portion 92, a flat upper portion 94, and a flat lower portion 96. Tubular body 90 may be formed, for example, by three-dimensional weaving, knitting, or braiding. Upper portion 94 may be folded or bent over lower portion 96 to form two layers of the sealing member.

[0058] 8-13 illustrate a technique for attaching the inflow edges 30 of the leaflets 20 to the frame 12, according to one embodiment. In the illustrated embodiment, a linking skirt 100 is secured to the lower edge portion 102 (also referred to as the leaflet edge portion) of each leaflet. As best shown in FIG. 9, each linking skirt 100 may comprise an elongated, generally rectangular body 104 formed with multiple flaps 106a, 106b formed along opposite longitudinal edges of the body 104. The skirt 100 may comprise any suitable synthetic material (e.g., PET) or natural tissue.

[0059] 10 and 10A, to secure the connecting skirt 100 to the leaflet 20, the body 104 is folded along a central longitudinal crease that bisects the body to form folds 110a, 110b, which are then placed on either side of the lower edge portion 102 of the leaflet 20 so that flap 106a lies adjacent the outer surface of the leaflet and flap 106b lies adjacent the inner surface of the leaflet. Sutures may then be used to form stitches 108 that extend longitudinally through both portions 110a, 110b of the body 104 and the lower edge portion 102 of the leaflet, as well as along the length of the lower edge portion 102. FIG. 11A shows a flattened view of the leaflet 20 with the skirt 100 folded around the lower edge portion 102 of the leaflet. FIG. 11B shows a flattened view of the leaflets 20 and skirt 100 after they have been secured to the leaflets with stitches 108.

[0060] 12, 12A, and 12B, each pair of flaps 106a, 106b is folded over a respective strut 22 of the frame and away from the leaflet 20 and secured in place with stitches 112 that extend through the flaps 106a, 106b along a stitching line on the exterior of the frame 12. As best shown in FIG. 12B, the connecting skirt 100 attaches the leaflet to the frame 12 so that the lower edge portion 102 extends radially inward at an angle of approximately 90 degrees relative to the frame 12. This effectively shifts the bending axis of the lower edge portion 102 inward, away from the inner surface of the frame, and toward the center of the frame.

[0061] 8 , each skirt 100 is secured to the frame along a diagonal line 116 that extends along the curved surface of the frame defined by the diagonally extending rows of struts 22 extending from the inflow end toward the outflow end of the frame. As such, the lower edge portion 102 of each leaflet is also positioned along a respective diagonal line 116 defined by the respective diagonally extending rows of struts 22. Advantageously, this reduces tension and wrinkle formation in the leaflets 20.

[0062] The attachment along the diagonal line 116 also helps reduce the crimp profile of the prosthetic valve when it is radially compressed into the delivery configuration. In particular, while struts in a row of struts extending circumferentially around the frame are moved or bent toward one another during the crimping process, struts located along the diagonal line 116 substantially maintain their alignment relative to one another along the line 116 during the crimping process. As such, the linking skirt 100 (typically formed from a non-stretchable material) does not prevent the struts from moving or deforming relative to one another. Additionally, because the leaflet edge portions of the leaflets move with the linking skirt during crimping, stretching of the leaflets along the leaflet edge portions is prevented or at least minimized.

[0063] FIG. 13A is a perspective view of the frame 12 and the leaflet 20 supported therein shown in an attached configuration, with the connecting skirt 100 removed for illustrative purposes. FIG. 13B is an enlarged, partial cross-sectional view of the frame and leaflet. As shown, the lower edge portion 102 of the leaflet extends perpendicularly or inversely parallel to the frame, forming a gap G between the inner surface of the frame and the bending axis 114 of the leaflet 20. Advantageously, this helps prevent or at least minimize contact of the outer surface of the leaflet with other relatively abrasive components, such as the frame and sutures, as the leaflet opens during valve operation, thereby preventing undesirable wear of the leaflet caused by contact with the frame. The increased space between the leaflet and the frame may also facilitate blood washout on the leaflet at the leaflet's bending axis.

[0064] Furthermore, in known prosthetic valves, care must be taken to prevent damage to the leaflets by preventing them from extending through the open cells of the frame during crimping. For example, known crimping devices for prosthetic valves may include features or attachments that urge the leaflets away from the frame during crimping or protect the leaflets from extending through the frame cells. In contrast, skirt 100 helps maintain at least the inflow portion of the leaflets spaced apart from the inner surface of the frame during crimping of the prosthetic valve, alleviating the need for such spaced crimping attachments.

[0065] Furthermore, the connecting skirt 100 (and other connecting skirts described herein) may facilitate assembly of the prosthetic valve compared to known assembly techniques. For example, the leaflets and skirt may be assembled while the valve structure 14 is in a flat configuration, prior to forming the tubular (annular) configuration. Automated or semi-automated techniques may be utilized to suture the skirt to the leaflets. Also, once the valve structure is positioned inside the frame 12, the lower edge portions 102 of the leaflets may be secured to the frame with stitching that is entirely outside the frame 12. This may significantly reduce assembly time, as the assembler does not need to thread a needle to form stitches 112 in and out of the frame cells 24.

[0066] As further shown in Figures 13A-13B, each leaflet 20 includes two tabs 60. Each tab 60 can be secured to an adjacent tab 60 on an adjacent leaflet 20 to form a commissure that is secured to the frame 12. Each tab 60 can be folded over to form a radially extending layer 60a and a circumferentially extending layer 60b that faces the frame. Methods for attaching the commissures to the frame are described in detail below and can be incorporated into the prosthetic valve shown in Figures 13A-13B.

[0067] The tab layer 60a can have a beveled edge 62 that extends radially inward from a location on the frame to the coaptation edge 64 of the valve leaflet. The beveled edge 62 also extends axially from that location on the frame to the coaptation edge 64. This positions the center of the coaptation edge 64 (the midpoint between adjacent commissures) lower than the attachment area of ​​the tab 60 to the commissures and the frame. In other words, the commissures are positioned at different locations along the height of the frame than the center of the coaptation edge 64. This configuration is advantageous in distributing stress more evenly along the tab 60 during valve cycling. In some embodiments, the entire coaptation edge 64 of the valve leaflet is lower than the attachment area of ​​the commissures to the frame, at least when the leaflet is in the closed position.

[0068] During the valve cycle, the leaflets can articulate at the innermost edge 66 of the tab layer 60a, which helps space the leaflets from the frame during normal operation of the prosthetic valve. This is particularly advantageous when the prosthetic valve is not fully expanded to its nominal size when implanted in a patient. This allows the prosthetic valve to be implanted in a variety of patient annulus sizes. When the prosthetic valve is under relatively high forces, such as when it is radially compressed for delivery, the leaflets can spread apart from each other on the frame to relieve stress on the leaflets.

[0069] Typically, the commissures and coaptation edges of the valve leaflets are relatively large portions of the leaflets and may prevent full radial compression of the prosthetic valve if they were flush along the frame. Another advantage of the commissure tabs 60 shown in Figures 13A and 13B is that the commissures and coaptation edges are spaced axially apart from each other when the prosthetic valve is radially compressed for delivery into the patient's body. By spacing these portions of the leaflets apart, the overall crimp profile of the prosthetic valve is reduced.

[0070] Figures 14 and 15A-15D show an alternative technique for attaching the lower edge portion 102 of the leaflet to the frame 12 using a connecting skirt 100. As shown in Figure 14, a slit 120 can be formed along the bottom section of the edge portion 102 to facilitate folding of the edge portion during the assembly process. Figures 15A-15D show a step-by-step process for attaching the skirt 100 to the leaflet 20 and then attaching the skirt to the frame.

[0071] 15A , the skirt 100 is folded to form a first layer 124 and a second layer 126, and the folded skirt is placed along the upper surface of the valve leaflet 20. The leaflet edge portion 102 is then wrapped around the folded edges of the skirt 100 to form a first leaflet layer 128 and a second leaflet layer 130 that sandwich the skirt layers 124, 126. The layers 124, 126, 128, 130 may then be secured to one another with stitches 132 that extend longitudinally through all four layers and along the length of the leaflet edge portion 102. An advantage of folding the leaflet edge portion 102 is that the leaflet may better resist being pulled through the stitches 132.

[0072] 15B, the second skirt layer 126 may then be folded around the two leaflet layers 128, 130 to form a third skirt layer 134 adjacent to the second leaflet layer 130 and a fourth skirt layer 136 adjacent to the first leaflet layer 128. Referring to FIG. 15C, the first skirt layer 124 may then be folded back over the third skirt layer 134 to form a fifth skirt layer 138. The fourth skirt layer 136 may be folded upon itself to form a sixth skirt layer 140. All six skirt layers and two leaflet layers may be secured together with stitches 142 that extend longitudinally through all eight layers and along the length of the edge portions 102 of the leaflets. Additionally, the fifth layer 138 and the sixth layer 140 may each be secured together at a location radially outwardly spaced from the leaflets 20 using stitches 144 that extend longitudinally through both layers and along the length of the skirt 100.

[0073] The leaflet and skirt assembly may then be secured to the frame 12. As shown in FIG. 15D , for example, skirt layers 138, 140 may be positioned beneath the struts 22 of the frame and secured to the frame using, for example, stitches 146 extending around the struts and through the layers 138, 140. Alternatively, stitches 144 may be wrapped around the struts of the frame to attach the leaflet and skirt assembly, instead of or in addition to stitches 146. Thus, the lower edge portion of each leaflet extends along a diagonal line immediately below line 116 ( FIG. 8 ) defined by the diagonal row of struts. Attaching the skirt beneath the diagonal row of struts 22 reduces movement of the skirt relative to the frame and resulting wear on the skirt, protecting it from tearing during operation of the prosthetic valve.

[0074] In an alternative embodiment, the skirt may be secured to the frame by placing the fifth layer 138 over the struts and the sixth layer 140 below the struts and securing the layers directly to each other (e.g., with sutures) outside the frame in a manner similar to how the skirt is secured to the frame in FIG. 12.

[0075] 16-18 show alternative configurations for assembling the skirt 100 and leaflets 20 using folded leaflet edge portions. In FIG. 16, the skirt 100 is folded around the leaflet layers 128, 130 to form a first skirt layer 150 below the leaflet layer 130, a second skirt layer 152 between the leaflet layers 128, 130, and a third skirt layer 154 above the leaflet layer 128. The leaflets and skirt may be secured to one another using stitches 156 that extend longitudinally through the skirt layers 150, 152, 154 and the leaflet layers 128, 130 and along the length of the leaflet edge portions 102. The configuration of FIG. 16 uses fewer skirt layers than FIGS. 15A-15D and may allow for a lower overall crimp profile for the prosthetic valve 10. FIG. 17 is similar to FIG. 16 except that the first skirt layer 150 is folded inward to form an additional, fourth skirt layer 158 between the first skirt layer 150 and the lower surface of the leaflet 20. This fourth skirt layer 158 may help prevent leaflet abrasion by positioning the skirt edge away from the articulating portion of the leaflet. FIG. 18 uses the same configuration as the embodiment of FIGS. 15A-15D, except that in the embodiment of FIG. 18, stitches 160 extend through the skirt layers 124, 126, 134, 136 and leaflet layers 128, 130, but not through the skirt layers 138, 140. The leaflet and skirt assemblies shown in FIGS. 16-18 may be secured to the frame 12 as previously described.

[0076] 19-21 illustrate another configuration for assembling the leaflets 20 and skirt 100. As shown in FIG. 19, the skirt 100 is folded around the lower edge portion 102 of the leaflet 20 to form first and second skirt layers 170, 172 on the lower surface of the leaflet and third and fourth skirt layers 174, 176 on the upper surface of the leaflet. The inner edges of the folded layers may be secured with stitches 178 that extend longitudinally through all four layers 170, 172, 174, 176 and along the length of the skirt and leaflets. As shown in FIGS. 20 and 21, the skirt 100 may then be attached to the frame 12 by positioning the outer edges of the skirt layers 170, 176 beneath the diagonal rows of struts 22 and securing the layers to each other and to the struts with stitches 180. Stitches 180 extend through layers 170, 176 and around struts 22' that intersect with and above the diagonal row 116 of struts 22.

[0077] Figure 22 shows a configuration similar to that shown in Figures 19-21 except that a section of the leaflet lower edge portion 102 extends through the cells of the frame. A first row of stitches 182 may be used to secure the leaflet lower edge portion 102 to the inner edges of the folded layers 170, 172, 174, 176. A second row of stitches 184 may be used to secure the leaflet lower edge portion 102 to the outer edges of the folded layers 170, 172, 174, 176 at an exterior location on the frame. The leaflet lower edge portion 102 may be formed with a series of slits 186 spaced along the length of the leaflet to correspond to the locations of the struts 22 so that a section of the lower edge portion 102 may extend through the cells of the frame.

[0078] 23 is a schematic illustration of attachment of a leaflet 20 to a frame using a connecting skirt 100. In the illustrated embodiment, the outer edge of the connecting skirt 100 can be secured (e.g., by sutures, adhesive, or welding) to an annular inner skirt 190, which in turn can be secured (e.g., by sutures, adhesive, or welding) to struts of the frame. Alternatively, the outer edge of the connecting skirt 100 can be attached directly to the struts of the frame without the inner skirt 190, as previously described in connection with the embodiment of FIGS. 8-22. The inner edge of the connecting skirt 100 can be connected (e.g., by sutures) to each lower edge portion 102 of the leaflet, which can be spaced from the inner skirt 190 and / or the inner surface of the frame 12 by the connecting skirt. In certain embodiments, for example, the width of skirt 100 between the lower edge of each leaflet 20 and the inner surface of inner skirt 190 and / or frame 12 can be from about 1 mm to about 5 mm.

[0079] Forming the interlocking skirt 100 from a fiber (e.g., PET) can promote tissue ingrowth and the formation or attachment of biological components, such as fibrin and other blood components, along the upper surface of the interlocking skirt during valve operation. The material attachment of the skirt 100 makes the skirt 100 substantially thicker and more rigid, thereby resisting flexing of the skirt during the valve cycle. As a result, the normal closed position of the valve leaflets is dictated by the diastolic blood pressure on the leaflets. During systole, the skirt 100 remains substantially stationary, forming a gap between the leaflets and the inner surface of the inner skirt 190 and / or frame 12, which can protect the leaflets from wear due to contact with those components of the prosthetic valve.

[0080] 24-25 illustrate another configuration for attaching the lower scalloped edge portion 102 of the valve leaflet to the frame 12. As shown in FIG. 24, the lower edge portion 102 of the valve leaflet 20 can be folded upward toward the outflow end of the frame and against the inner surface of the frame to form a bending axis between the lower edge portion and the remainder of the leaflet that can articulate toward and away from the frame during the valve cycle. The bending axis of the leaflet is thus spaced inward from the frame, which can provide several benefits, including protection against leaflet abrasion during valve cycling, reduced stress along the lower edge of the leaflet during valve closure, improved blood washout of the leaflet (thus eliminating or at least minimizing premature calcification in those regions), and improved leaflet closing motion. A reinforcing member 200, such as a wire, cord, sleeve, fiber, or suture, can be positioned along the upper surface of the leaflet at the bending axis where the lower edge portion 102 intersects with the articulating portion of the leaflet. In other embodiments, the reinforcing member 200 may be positioned along the inferior surface of the valve leaflet. The reinforcing member 200 may comprise, for example, a multifilament suture (e.g., an Ethibond suture).

[0081] The leaflets 20 can be coupled to the frame 12 using a variety of techniques or mechanisms. As shown in FIGS. 25A-25B , for example, the leaflets 20 can be coupled to the frame 12 using a connecting skirt 202 having an inner longitudinal edge portion 204 and an outer longitudinal edge portion 206. The inner edge portion 204 can be folded upward against the leaflet's lower edge portion 102. The outer edge portion 206 can be folded downward against an outer skirt 210 (which can include, for example, a sealing member 16) attached to the exterior of the frame. The outer edge portion 206 can contact the outer skirt 210 through the frame cells at locations below the diagonal rows of struts 22. The connecting skirt 202 can comprise two layers of material 202 a, 202 b, for example, by folding the skirt lengthwise before assembling the skirt to the leaflets. Alternatively, the connecting skirt 202 can comprise a single layer of material.

[0082] The inner edge portion 204 may be secured to the leaflets 20 by stitches 208 that pass through the skirt 202, leaflets 20, and reinforcing member 200 and extend longitudinally along the leaflets and skirt. The outer edge portion 206 may be secured to the outer skirt 210 by stitches 212 that pass through and extend longitudinally along the connecting skirt 202 and outer skirt 210. As shown in FIG. 25B, the connecting skirt 202 may also be secured directly to the frame by stitches 212 or by separate stitches that pass through the outer edge portion 206 of the skirt 202 and extend around the intersection 50 of the frame where two struts intersect. The connecting skirt may remain unattached at the apex 216 formed by the intersection of each pair of struts 22 at the inflow end of the frame.

[0083] Desirably, the rows of stitches 212 extend above the apexes 216, as shown, to prevent the leaflets from protruding below the inflow end of the frame, thereby protecting the leaflets from contacting adjacent native tissue, such as calcium nodules, before or during deployment of the prosthetic valve 10. Folding the lower edge portions 102 of the leaflets upward, away from the connecting skirt 202, and toward the outflow end of the frame minimizes the amount of overlapping layers of material of the skirt 202, leaflets 20, and frame 12, thereby reducing the overall crimp profile of the prosthetic valve.

[0084] Figure 26 shows an alternative configuration for attaching the leaflets 20 to the frame using a connecting skirt 202. The embodiment of Figure 26 can be identical to the embodiment of Figures 24 and 25, except that the outer edge portion 206 of the connecting skirt 202 extends between the lower edge portion of the upper outer skirt 218 and the upper edge portion of the lower outer skirt 220. The connecting skirt 202, the upper outer skirt 218, and the lower outer skirt 220 can be secured to one another with stitches 222 that extend through all three layers of material.

[0085] Figure 27 shows another alternative configuration for attaching the leaflets 20 to the frame using a connecting skirt 202. The embodiment of Figure 27 can be identical to the embodiment of Figures 24 and 25, except that the outer edge portion 206 of the connecting skirt 202 can be folded upward toward the outflow end of the frame. The outer edge portion 206 can be secured to the outer skirt 210 with stitches 212.

[0086] Figures 28 and 29 show in more detail various methods of suturing the inner edge portion 204 of the connecting skirt 202 to the lower edge portion 102 of the valve leaflet 20. In Figure 28, the stitch 208 extends through the inner skirt layer 202b but not through the outer skirt layer 202a. In Figure 29, the stitch 208 extends through both skirt layers 202a, 202b.

[0087] Figure 30 shows another configuration for attaching the lower edge portion 102 of the leaflet to the frame 12. As shown in Figure 30, the lower edge portion 102 of the leaflet may be joined to the frame 12 with a connecting skirt 230 having an upper edge portion 232 and a lower edge portion 234. The upper edge portion 232 may be secured to the outer skirt 210 above the diagonal row of struts 22 with stitches 236 extending through the outer skirt and the connecting skirt. The lower edge portion 234 of the connecting skirt may be secured to the outer skirt below the diagonal row of struts 22 with stitches 238 extending through the outer skirt and the connecting skirt. An intermediate portion of the connecting skirt (between the upper edge portion 232 and the lower edge portion 234) may extend over the diagonal row of struts.

[0088] As shown in FIG. 30 , the spacing between a row of struts and stitch 236 is desirably greater than the spacing between a row of struts and stitch 238, thereby increasing the contact angle between the skirt and strut 22. The circled area 240 in FIG. 30 represents the contact area where contact occurs between the connecting skirt 230 and the frame 12, or where the majority of contact occurs between the connecting skirt and the frame. Under systole, the angle of the skirt 230 relative to the transverse axis of the frame (the transverse axis is perpendicular to the longitudinal axis of the frame) at contact area 240 is approximately 60-90 degrees, or more preferably approximately 70-90 degrees, or even more preferably approximately 80-90 degrees. Increasing the skirt contact angle reduces bending stresses in the skirt during valve cycling, improving skirt durability. Additionally, the connecting skirt 230 may be sized or configured such that during diastole, the connecting skirt may move slightly radially inward under blood pressure, moving away from the skirt 230 of the strut 22 and thereby eliminating or minimizing contact between the skirt and the strut.

[0089] Figure 31 shows another configuration for attaching the lower edge portions 102 of the leaflets to the frame 12 using a connecting skirt 230, similar to the embodiment of Figure 30, except that the upper edge portion 232 of the connecting skirt is secured to the struts 22a in the upper diagonally extending row and the lower edge portion 234 of the connecting skirt is secured to the struts 22b in the lower diagonally extending row. In this manner, the lower edge portions 102 of the leaflets can be secured to the connecting skirt 230 between the upper and lower rows of struts. The upper edge portion 232 of the connecting skirt can be at least partially wrapped around the struts 22a in the upper row but secured in place by loop stitches 250 extending through the skirt and around the struts 22a. The lower edge portion 234 of the connecting skirt can be at least partially wrapped around the struts 22b in the lower row but secured in place by loop stitches 252 extending through the skirt and around the struts 22b. By attaching the connecting skirt 230 to two adjacent diagonally extending rows of struts in the manner shown in FIG. 31, relative movement between the connecting skirt and the frame may be prevented or at least minimized, thereby improving the durability of the skirt.

[0090] Figure 32 shows another configuration for attaching the lower edge portions 102 of the leaflets 20 to the frame 12 without a connecting skirt. In the embodiment of Figure 32, the lower edge portions 102 of the leaflets 20 are folded upward against a diagonal row of struts 22 and secured in place with loop stitches 254 that extend around the struts 22 and through the leaflet edge portions 102 at a first location, through the reinforcing member 200, and through the leaflet edge portions 102 at a second location. Positioning the folded edge portions 102 of the leaflets parallel to the inner surface of the struts may minimize abrasion of the leaflets due to movement of the leaflets relative to the frame. The elimination of the skirt in this embodiment may reduce the overall crimp profile of the prosthetic valve, providing a tighter connection between the leaflets and the frame, thereby reducing relative movement between these two components.

[0091] 33-37 illustrate a technique for attaching a commissure portion of a valve structure to a frame, such as commissure portion 32 to frame 12, according to one embodiment. FIG. 33 shows a leaflet 300 having a lower edge portion 302 that can be attached to frame 12 using any of the previously described embodiments. Lower edge portion 302 terminates at its upper end in two laterally projecting integral lower tabs 304. Integral upper tabs 306 (also referred to as commissure tabs) project from the upper corners of leaflet 300. Upper tabs 306 can be spaced from lower tabs 304 by side edges 338 to define laterally extending gaps or recesses in the leaflet.

[0092] To assemble the commissures, each upper tab 306 is folded along a horizontal fold line 308 to form first and second tab layers 306a, 306b, as shown in FIG. 33 (see also FIG. 37). A first vertically extending reinforcing member 310 may be positioned against the first tab layer 306a adjacent its inner edge. A second vertically extending reinforcing member 312 may be positioned against the second tab layer 306b on the opposite side of the first reinforcing member 310. The first and second tab layers 306a, 306b may be secured to one another by stitches 314 extending through the first and second tab layers 306a, 306b and the first and second reinforcing members 310, 312.

[0093] First and second tab layers 306a, 306b are then folded lengthwise along vertical fold lines to form outer fold portion 316 and inner fold portion 318 extending radially inward from outer fold portion 316, as shown in FIG. 35. A third vertically extending reinforcing member 320 may be positioned against first fold layer 306a of outer fold portion 316, and a commissure attachment member 322 may be positioned against second fold layer 306b of outer fold portion 316. Outer fold portion 316 may be secured to commissure attachment member 322 by stitches 324 extending through third reinforcing member 320, first and second tab layers 306a, 306b, and commissure attachment member 322. The outer edges of the first and second tab layers 306a, 306b may be further secured to commissure attachment members 322 with stitches 326. The upper tabs 306 of the second leaflet 300 may be assembled in the same manner as each reinforcing member and attached to the commissure attachment members 322 adjacent the first leaflet to form the commissures 328 as shown in FIG. 37. The commissure attachment members 322 may then be secured to struts of a frame (see, e.g., FIG. 65), as described further below.

[0094] The folding tab layers 306a, 306b, reinforced by the first and second reinforcing members 310, 312, may have a higher resistance to bending or articulation than the portion 330 of the leaflet located radially inward of the tab layers. This allows the leaflet 300 to primarily articulate at the inner edge 332 of the folding layer 306a in response to blood flow through the prosthetic valve during operation in vivo, as opposed to articulating about axes on or adjacent to the metal struts of the frame. Because the leaflets articulate at a location spaced radially inward from the frame 12, the leaflets can avoid contact with and damage from the frame. This is particularly advantageous when the prosthetic valve does not fully expand to its nominal size when implanted in a patient. This allows the prosthetic valve to be implanted within a variety of patient annulus sizes.

[0095] Under large forces, the folding tab layers 306 a, 306 b of adjacent leaflets can spread apart from each other about their respective axes 334 ( FIG. 37 ) adjacent the frame 12, with each inner folding portion 318 folded relative to each outer folding portion 316. For example, this can occur when the prosthetic valve 10 is press-fit onto the shaft of a delivery device, allowing for a smaller crimp diameter. Also, the folding tab layers can spread apart about their axes 334 when the balloon of the balloon catheter is inflated during expansion of the prosthetic valve, thereby relieving some of the pressure on the commissures caused by the balloon, so that the commissures are not damaged during expansion.

[0096] Once the leaflets 300 are attached to the frame, the inferior tabs 304 of each leaflet may be folded downward against the leaflet edge portion 302 and held in place using sutures or the like. The folded inferior tabs 304 help reinforce the connection between the leaflet edge portion 302 of the leaflet and the frame along the upper section of the leaflet edge portion adjacent the commissures. The folded inferior tabs 304 also prevent or minimize contact between the leaflets and the frame in the areas below the commissures by shifting the bending axis of the upper section of the leaflet edge portion inward and away from the inner surface of the frame.

[0097] The side edges 338 between the lower tabs 304 and upper tabs 306 can be left unattached to the frame of the prosthetic valve (see FIG. 1C ). The unattached side edges 338 provide several benefits, including reducing stress on the leaflets by allowing greater axial elongation or stretching of the leaflets when the prosthetic valve is compressed from a radially expanded state to a radially compressed state during the crimping process and by allowing greater radial elongation or stretching of the leaflets when the prosthetic valve is expanded to a radially expanded state. The unattached side edges 338 also allow blood to flow into the space between the pair of side edges 338 of the adjacent leaflets and the inner surface of the frame, thereby reducing blood stagnation and thrombus formation. During diastole, the adjacent side edges 338 can abut against each other, preventing retrograde blood flow between the side edges 338. During systole, adjacent side edges 338 separate from one another, allowing antegrade blood to flow between side edges 338 and may help wash blood away from the area below the commissures.

[0098] The reinforcing members 310, 312, 320 desirably comprise a relatively soft and flexible non-metallic material. For example, the reinforcing members can comprise a multifilament suture (e.g., Ethibond suture), or a strip of synthetic material such as a fibrous material (e.g., PET) or a non-fibrous material (e.g., silicone or polyurethane), or natural tissue (e.g., pericardium). The commissure attachment members 322 can similarly comprise a soft and flexible non-metallic material, such as a strip of synthetic material such as a fibrous material (e.g., PET) or a non-fibrous material (e.g., silicone or polyurethane), or natural tissue (e.g., pericardium). Thus, in the illustrated embodiment, the commissures 328 do not include metallic components or other materials of similar stiffness. The absence of such materials reduces wear and abrasion of the leaflet material and allows for a reduced overall crimp profile of the prosthetic valve.

[0099] Figure 38 illustrates a modification of the embodiment shown in Figure 37. The embodiment of Figure 38 may be identical to the embodiment of Figure 37, except that a pair of fold layers 306a, 306b of adjacent leaflets 300 may be secured together with sutures 336 extending through the reinforcing members 310, 312 and tab layers 306a, 306b of each leaflet 300. Securement of the leaflets together may reinforce the bending axis of the leaflet articulation portion 330 during normal valve operation.

[0100] 39 shows an alternative embodiment of leaflet 340, similar to leaflet 300, except that leaflet 340 includes upper tabs 341 that project laterally a greater distance than upper tabs 306. Each upper tab 341 may be folded widthwise along respective vertical fold lines 342 to form two folded tab layers that mate with the folded tab layer of an adjacent leaflet, thereby forming a commissure as previously described.

[0101] 40-46 illustrate another embodiment of a valve leaflet and a method for forming a commissure from two leaflets. As shown in FIG. 40, a leaflet 400 includes a lower edge portion 402 terminating in a lower tab 404, with an upper tab 406 (also called a commissure tab) spaced from the lower tab 404 by a gap 408. The lower tab 404 can be folded downwardly against the lower edge portion 402 to reinforce those areas of the leaflet and shift the bending axis of the upper section of the edge portion 402 (the portion immediately below the commissure) inward and away from the inner surface of the frame, as previously described.

[0102] Each upper tab 406 includes a lower tab portion 410, an upper tab portion 412 extending from the lower tab portion, and a side tab portion 414 extending laterally inward from the upper tab portion. To form the commissures, a reinforcing member 418 (e.g., a multifilament suture or fiber strip) may be vertically positioned along the upper tab portion 412 in the manner shown in FIG. 41 . The side tab portion 414 may then be folded relative to the upper tab portion 412 along fold line 416 as shown in FIGS. 41-42 . The double layer of side tab portion 414 and upper tab portion 412 may then be folded relative to the lower tab portion 410 along horizontal fold line 420 as shown in FIGS. 42-43 .

[0103] 44, a commissure attachment member 422 may then be placed against the posterior (outer) surface of the lower tab portion 410 and secured to the upper tab 406 using stitches 424 extending through the upper tab portion 412, the reinforcing member 418, the side tab portion 414, the lower tab portion 410, and the commissure attachment member 422. The three layers formed by the lower tab portion 410, the upper tab portion 412, and the side tab portion 414 may then be folded into an L-shape to form an outer fold portion 426 adjacent the commissure attachment member 422 and an inner fold portion 428 extending radially inward from the outer fold portion, as shown in FIG. 46. The tab layer of the outer fold portion 426 may be further secured to the commissure attachment member 422 using stitches 432, as shown in FIG. The upper tabs 406 of the other leaflets may be assembled in the same manner and secured to the same commissure mounting members 422 to form commissures 430 as shown in FIGS.

[0104] As described above, the stitches 424 may extend through each layer formed by the lower tab portion 410, the upper tab portion 412, and the side tab portion 414. As shown in FIG. 46 , the stitches 424 from each commissure tab 406 may extend diagonally from one another to compress the folded commissure tabs 406 against one another and against the commissure attachment member 422. In alternative embodiments, the stitches 424 may be disposed through the reinforcing member 418, the side tab portion 414, and the lower tab portion 410 prior to folding the upper and side tab portions along the fold line 420. In this manner, the stitches 424 need not extend through the upper tab portion 412 as shown in FIG. 46 . In some embodiments, a separate reinforcing member 438 may be disposed against the outer surface of the commissure attachment member 422 ( FIG. 46 ). The stitches 424 from each commissure tab 406 may extend through the reinforcement member 438 at the same location as shown or at spaced locations.

[0105] The commissures 430 may function similarly to the commissures 328 described above. Thus, during the normal valve cycle, the leaflets 400 may articulate about their respective axes at the inner ends 434 of the tab layer 412. Compression of the folded commissure tabs 406 by the stitches 424 helps maintain the normal bending axes of the leaflets 400 away from the frame. During valve deployment, the leaflets may spread apart from each other at the axes 436 adjacent the commissure mounting members 422.

[0106] Figure 47 illustrates an alternative configuration for forming the commissures. The embodiment of Figure 47 is similar to the embodiment of Figures 33-37, except that a vertical reinforcing member 344 may be positioned between the two layers of the commissure tabs of the leaflet. The commissures may be formed by placing the reinforcing member 344 on the tab portion 306a before folding the tab portion 306a along the fold line 308. After folding the commissure tabs 306, the folded layers 306a, 306b may be secured to the commissure attachment member 322 by stitches 346 extending through the reinforcing member 344, both tab layers 306a, 306b, and the commissure attachment member 322.

[0107] Figure 48 shows an alternative configuration for forming the commissures, similar to that of Figure 46, except that each folded commissure tab 406 is secured to a separate reinforcing member 438 (one of which is shown in Figure 48). Stitches 440 may also secure the side tab portions 414 to the reinforcing member 418.

[0108] 49-54 illustrate another embodiment of a valve leaflet and a method for forming the commissures 32 from two leaflets. As shown in FIG. 49, the leaflet 500 includes a lower edge portion 502 terminating in a lower tab 504, with an upper tab 506 (also called a commissure tab) spaced from the lower tab 504 by a gap 508. The lower tab 504 may be folded downwardly against the lower edge portion 502 to reinforce those areas of the leaflet as described above and to shift the bending axis of the upper section of the edge portion 502 (the portion immediately below the commissure) inward, away from the inner surface of the frame.

[0109] Each commissure tab 506 includes a lower tab portion 510 and an upper tab portion 512. To form the commissure, the upper tab portion 512 is folded relative to the lower tab portion 510 along fold line 514. The bilayer including the tab portions 510, 512 may then be folded along vertical fold lines 516 to form a first layer 518, a second layer 520, a third layer 522, and a fourth layer 524 from each commissure tab 506, as shown in FIGS. 50-52. A reinforcing member 526, such as a fabric (e.g., PET) strip, may be positioned between the second layer 520 and the third layer 522.

[0110] The commissure tabs 506 of another leaflet 500 can be folded in the same manner and positioned against the folded commissure tabs of the first leaflet within the commissure attachment member 528. The commissure attachment member 528 can be folded as shown in FIG. 50 to form a central outer portion 530, outer end portions 532, and side portions 534, each comprising a first layer of material 534a and a second layer of material 534b extending from each end of the end portion 532 and central outer portion 530, respectively. The side portions 534 can be positioned against each fourth layer 524 of the commissure tabs.

[0111] 50 , the layers 534a, 534b of each side portion 534 may be secured to one another by stitches 536. Each side portion 534 may be secured to the commissure tabs 506 by stitches 538 that extend through each reinforcement member 526, each of the third and fourth layers 522, 524, and both layers of each side portion 534. The commissure attachment members 528 may be secured to the struts 22 of the frame 12 by sutures or other techniques or mechanisms.

[0112] Figure 51 illustrates another method of securing the folded commissure tabs 506 to the commissure attachment members 528. As shown in Figure 51, for each commissure tab, a row of laterally extending stitches 540 may be used to secure the inner end portions of the side portion layers 534a, 534b, the third and fourth layers 522, 524, and the reinforcement member 526. A diagonally extending row of stitches 542 may be used to secure the reinforcement member 526, the third and fourth layers 522, 524, and the posterior end portions of the side portion layers 534a, 534b.

[0113] As shown in FIGS. 52-53 , each commissure 32 can include an inner sleeve 544 and an outer support member 546. The inner sleeve 544 can include a first portion 544 a and a second portion 544 b, which extend around the outer sides and upper and lower portions, respectively, of each folded commissure tab 506. Adjacent upper ends 548 of the first and second portions 544 a and 544 b can be secured to one another (e.g., with sutures) at the center of the commissure 32. Adjacent lower ends of the first and second portions 544 a and 544 b can likewise be secured to one another (e.g., with sutures) at the center of the commissure 32. Each side portion 534 of the commissure mounting member 528 may be secured (e.g., with sutures) to one of the first and second portions 544a and 544b of the inner sleeve. The outer support member 546 may be secured (e.g., with sutures) to the central outer portion 530 and / or the end portions 532 of the commissure mounting member 528.

[0114] As shown in FIG. 54 , at least a portion of the outer support member 546 can be positioned external to the frame 12. The outer support member 546 can be secured (e.g., with sutures) to each strut 22 in a set of struts that form a cell of the frame. In the illustrated embodiment, for example, the outer support member 546 is sutured to each strut of a diamond-shaped cell comprised of four struts 22. The inner sleeve 544 and the outer support member 546 can comprise any suitable relatively flexible and soft material, such as those previously described for the reinforcement members and commissure attachment members of the previous embodiments. In certain embodiments, the inner sleeve 544 and the outer support member 546 comprise PET fibers.

[0115] Figure 55 illustrates a modification of the commissures 32 shown in Figures 52-54. The embodiment of Figure 55 can be identical to the embodiment of Figures 52-54, except that it includes a reinforcing member 554 in the form of a multifilament suture positioned between the second layer 520 and the third layer 522 of each commissure tab 506.

[0116] FIG. 56 illustrates an alternative embodiment for forming commissures from two leaflets 300. The commissure tabs 306 may be folded in a manner similar to that described above with respect to the embodiment of FIGS. 33-37. As shown, a reinforcing member 350 (e.g., a strip of PET or other material) may be positioned in the fold of each layer 306a. A commissure attachment member 352 may be positioned against the outward fold 316 of each layer 306b and folded in the manner shown in FIG. 56 to form three layers of material 352a, 352b, and 352c in each layer 306b. For each commissure tab 306, a stitch 354 may be used to secure the reinforcing member 350, layers 306a, 306b, and the three folded layers of commissure attachment member 352.

[0117] 57-58 illustrate another embodiment of a prosthetic valve 600. The prosthetic valve 600 may be similar to the prosthetic valve 10 described above, except for the configuration of the sealing member. In the illustrated embodiment, the prosthetic valve 600 includes a sealing member 602 having an inner portion or layer 604 and an outer portion or layer 606. The inner layer 604 is attached to the interior of the frame 12 and includes three triangular-shaped portions 608. FIG. 59 shows the sealing member 602 in a flat configuration prior to attachment to the frame. The semi-triangular portions at each end of the sealing member form the triangular portions 608 when the sealing member is formed into a tubular or annular shape with the ends interconnected.

[0118] The upper edge portion 610 of the inner layer is shaped to correspond to the shape of the lower edge portion 102 of the leaflet 20. The lower edge portion 102 of the leaflet 20 may be directly connected (e.g., with sutures) to the upper edge portion 610 of the inner layer 604 using a connecting skirt (e.g., any connecting skirt described herein, such as skirt 100) or other attachment techniques described herein. The upper edge portion 610 of the inner layer 604 may be secured to the struts 22 of the frame 12, such as with the sutures used to connect the inner layer to the leaflet, or with separate sutures extending through the struts 22 and the inner layer. The inner layer 604 functions to prevent antegrade blood from flowing outward through the cells of the frame below the inflow edge of the leaflet.

[0119] The outer layer 606 may be wrapped around the inflow end 26 of the frame and secured (e.g., with sutures) along an upper edge portion 612 to struts 22 on the exterior of the frame 12. Individual sutures may be used to secure the outer layer 606 to the apexes of the inflow end 26 of the frame at circumferentially spaced locations.

[0120] The outer layer 606 may be shaped or configured to extend radially outward from the frame when the prosthetic valve is radially expanded to its functional size, forming a space 614 between the frame and the outer layer 606. When deployed in a patient, retrograde blood may flow over the outer surface of the leaflets 20, through the cells of the frame, and into the space 614 within the outer layer 606, helping to form a seal against the surrounding tissue. The absence of material within the frame facing the moving portions of the leaflets 20 may reduce the overall crimp profile of the prosthetic valve and prevent wear on the leaflets 20, especially if the prosthetic valve is not fully expanded to its nominal size. As a result, this allows the prosthetic valve to be implanted within a variety of patient annulus sizes.

[0121] The sealing member 602 can be formed from the same materials and using the same techniques as described above for the sealing member 16 .

[0122] 60-61 illustrate another embodiment of a prosthetic valve 700. This prosthetic valve 700 may be similar to the prosthetic valve 10 described above, except for the configuration of the sealing member. In the illustrated embodiment, the prosthetic valve 700 includes a sealing member 702 having an inner portion or layer 704 and an outer portion or layer 706. The inner layer 704 is attached to the exterior of the frame 12 and includes three triangular-shaped portions 708. In certain embodiments, the triangular-shaped portions 708 are connected only by thin strips 705.

[0123] Figure 62 shows the sealing member 702 before it is assembled onto the frame 12 and folded into its final shape. When installing the sealing member 702 onto the frame 12, the sealing member may first be placed on the frame as shown in Figure 63 with the inflow end portion of the inner layer 704 adjacent the inflow end 26 of the frame. The triangular portions 708 correspond to the shape of the lower edge portions 102 of the leaflets 20 and are shaped to cover the openings in the frame between adjacent edge portions 102 below each commissure. Due to the shape of the triangular portions 708, the inner layer 704 does not cover the portion of the frame that faces the outflow surface of the leaflets.

[0124] The lower edge portion 102 of the leaflet 20 may be directly connected (e.g., with sutures) to the upper edge portion 710 of the inner layer 704 using a connecting skirt (e.g., any connecting skirt described herein, such as skirt 100) or other attachment techniques described herein. The inner layer 704 functions to prevent antegrade blood from flowing outward through the cells of the frame below the inflow edge of the leaflet.

[0125] The outer layer 706 may then be folded onto the inner layer 704 toward the inflow end 26 of the frame, such that the upper end of the pre-folded outer layer becomes the lower (inflow) end of the outer layer and is located adjacent to the inflow end 26 of the frame, as shown in FIG. 60. Folding the outer layer onto the inner layer inverts the outer layer so that, in the folded, assembled state, the inner surface of the pre-folded outer layer becomes the outer surface of the outer layer, and vice versa. FIG. 64 shows the sealing member 702 in its final folded state, separated from the remainder of the prosthetic valve for illustrative purposes. After folding the outer layer 706, the inflow and / or outflow ends of the outer layer may be secured (e.g., with sutures) to the struts 22 of the frame.

[0126] Sealing member 702 may be formed from the same materials and using the same techniques as described above for sealing member 16. In an alternative embodiment, inner layer 704 and outer layer 706 may be separate pieces of material that may be secured to one another (e.g., by sutures) at their inflow and / or outflow ends.

[0127] Similar to the embodiment of FIGS. 57-59 , the outer layer 706 can be shaped or configured to extend radially outward from the frame when the prosthetic valve is radially expanded to its functional size, forming a space 714 between the frame and the outer layer 706. When deployed in a patient, retrograde blood can flow in the direction of arrow 716 over the outflow surfaces 70 of the valve leaflets 20, through the cells of the frame, and into the space 714 within the outer layer 706, helping to form a seal against the surrounding tissue. The triangular portions 708 prevent antegrade blood from flowing through the frame at locations between the leaflet edge portions 102 of the leaflets. The absence of material within the frame reduces the overall crimp profile of the prosthetic valve, which can prevent wear on the leaflets 20, especially if the prosthetic valve is not fully expanded to its nominal size. As a result, this allows the prosthetic valve to be implanted within a variety of patient annulus sizes.

[0128] FIG. 65 illustrates another embodiment of a prosthetic valve 800. The prosthetic valve 800 may include a sealing member 802 attached to a frame 12 as described above in connection with the embodiment of FIGS. 60-63. The prosthetic valve 800 may include leaflets 814 interconnected at their outflow ends to form commissures 810 that are attached to cells 24 at the outflow end of the frame. The commissures 810 may be formed by folding the commissure tabs of the leaflets and securing them to commissure attachment members 812. Each commissure attachment member 812 may be sutured to four struts 22 that define a closed cell 24 of the frame. Methods for forming the commissures 810 and attaching them to the cells 24 via the commissure attachment members 812 are described in detail below.

[0129] 68 shows sealing member 802 separate from the other components of the prosthetic valve. Sealing member 802 includes an inner layer 804 and an outer layer 806. Inner layer 804 may include a plurality of triangular-shaped portions 808. Sealing member 802 may have the same or similar configuration as sealing member 702, except that triangular-shaped portions 808 are not interconnected at their lower (inflow) ends. Sealing member 802 may be attached to frame 12 as described above in connection with sealing member 702.

[0130] 74-78, a method for forming the commissures 810 and attaching them to the frame 12 is described. As best shown in FIG. 75, each leaflet 814 has a lower edge or leaflet edge portion 816 that can be attached to the frame 12 using any of the previously described embodiments. The lower edge portion 816 terminates at its upper end in two laterally projecting integral lower tabs 818. Integral upper tabs 820 (also called commissure tabs) project from the upper corners of the leaflet 814. The upper tabs 820 can be spaced from the lower tabs 818 by side edges 819 to form laterally extending gaps or recesses 822 in the leaflet.

[0131] As shown in FIG. 75B , each upper tab 820 is folded along fold lines 824 to form first and second tab layers 820 a, 820 b, similar to the technique described above with respect to the leaflet 300 shown in FIGS. 33-37 . As described further below, the upper tabs 820, along with the upper tabs 820 of adjacent leaflets, are secured to the commissure attachment members 812 to form the commissures 810. FIG. 76 shows the commissure attachment members 812 in a flat configuration prior to folding and attachment to the leaflets. Each commissure attachment member 812 in the illustrated configuration includes first and second side portions 828 a, 828 b projecting laterally from a central portion 830. As shown, the outer peripheral edges 832 of the side portions 828a, 828b may be shaped to correspond to one half of the diamond-shaped cells 24 of the frame 12 to facilitate attachment of the commissure mounting members 812 to the struts 22 of the frame 12, as described further below.

[0132] 77-78 , after the upper tabs 820 of the leaflets 814 are folded, vertical reinforcement portions 826 can be secured, such as by stitching, to the inner surface of tab layer 820a. The folded tab layers 820a, 820b can be secured to side portions 828a or 828b of the commissure attachment member 812. The folded tab layers can then be folded into an L-shape along the vertical fold lines at reinforcement portions 826 such that tab layer 820b forms a first circumferentially extending layer 834a and a first radially extending layer 834b that is generally perpendicular to layer 834a, and tab layer 820a forms a second inward circumferentially extending layer 836a and a radially extending layer 836b that is generally perpendicular to layer 836a. Another upper tab 820 of an adjacent leaflet 814 may be similarly folded and secured to the other side portion 828 a or 828 b of the commissure mounting member 812 .

[0133] The commissure attachment member 812 may be folded to form an inner layer 838, two middle layers 840, and two outer layers 842, as shown in FIG. 78 . Each folded upper tab 820 may be secured to the inner layer 838 and the middle layer 840 with a stitch 844. In the illustrated embodiment, the stitches 844 are shown extending through the reinforcement member 826, layer 836a, layer 834a, layer 838, and layer 840. However, during the assembly process, multiple stitches can be used to secure each layer to the adjacent layer as each fold is made. For example, layers 834a, 836a can be secured to each other and to the reinforcement member 826 with separate stitches, and then additional stitches can be used to secure the leaflet layer to the inner layer 838 of the commissure attachment member 812, and further stitches can be used to secure the middle layer 840 to the inner layer 838. As best shown in FIG. 78, the commissure mounting members 812 may be folded to leave small gaps 846 between the outer layers 842.

[0134] The outer layer 842 may be secured to the frame 12, such as by sewing the outer peripheral edge 832 to the struts 22 with stitches 848. As described above, the outer peripheral edge 832 of the commissure attachment member 812 may generally correspond to the shape of the closed cells of the frame 12. For example, as shown in FIG. 71 , the frame 12 in the illustrated embodiment includes a plurality of generally diamond-shaped cells 24, with each generally diamond-shaped cell 24 formed by a strut 22 a, 22 b, 22 c, and 22 d. Stitches 848 may be used to sew the outer peripheral edge 832 of the commissure attachment member 812 to the struts 22 a, 22 b, 22 c, and 22 d to form the closed cells 24. The commissure attachment member 812 may further include upper and lower tabs 850, 852 protruding from the upper and lower edges of the central portion ( FIG. 76 ). Additionally, stitches 848 may be used to sew upper tab 850 to apex 854 formed by the intersection of struts 22a, 22c, and lower tab 852 to intersection 856 formed by the intersection of struts 22b, 22d.

[0135] The inflow or leaflet edge portions 816 of the leaflets 814 can be secured to the frame 12 using multiple linking skirts 860 ( FIG. 70 ), which can be formed from the same materials as those described above for the linking skirts 100 (e.g., PET fiber). In the illustrated embodiment, a single linking skirt 860 is provided for each leaflet edge portion 816 of each leaflet 814 and is sized to extend along the entire length of the leaflet edge portion 816 to a position just below the lower tab 818 of the leaflet 814. FIG. 75B shows the linking skirt 860 positioned along the leaflet edge portion 816 of the leaflet 814 before being attached to the leaflet with sutures. The linking skirt 860 can include a central portion 860 a sized to extend across the central lower edge portion and two side portions 860 b sized to extend across angled side edge portions that extend from the lower central portion to the lower tab 818. The connecting skirt 860 may be formed with slits 862 that partially separate the side portions 860b from the central portion 860a to facilitate alignment of the skirt along the leaflet edge portions, as shown in FIG. 75B.

[0136] In alternative embodiments, multiple linking skirts may be provided for the leaflet edge portions of each leaflet (e.g., central portion 860a and side portion 860b can be separate pieces of fabric). In another embodiment, a single linking skirt may be used to secure all of the leaflets to the frame, i.e., the single linking skirt may be sized to extend along the leaflet edge portions of all of the leaflets.

[0137] Prior to attaching the leaflets to the frame, a linking skirt 860 may be attached to the leaflet edge portion of each leaflet. As shown in FIG. 69 , the linking skirt 860 may be folded lengthwise to form two fold layers 864 a, 864 b and positioned against the inflow surface of the leaflet edge portion 816. A reinforcing member or reinforcing cord 866 (e.g., Ethibond suture) may be positioned against the outflow surface of the leaflet edge portion on the opposite side of the linking skirt 860. The reinforcing member 866 and fold layers 864 a, 864 b may be sutured to each other and to the leaflet edge portion 816 with stitches 868, which may be a single suture or multiple sutures extending through one or more layers of material.

[0138] When suturing the reinforcement cord 866 to the leaflet 814, the lower tab 818 may be folded downwardly against the leaflet edge portion 816 (see FIG. 75B ), and the reinforcement cord 866 may be placed over the folded lower tab 818. The upper end of the connecting skirt 860 may be sized to extend over the folded lower tab 818. A stitch 868 may be used to secure the reinforcement cord 866 in place against the folded lower tab 818. In certain embodiments, as best shown in FIG. 67 , the reinforcement cord 866 may extend along the folded lower tab 818 of one leaflet 814, through the space between a pair of adjacent lower tabs 818 and a pair of upper tabs 820 below the commissures 810, and further along the lower tab 818 and the leaflet edge portion of the adjacent leaflet 814. In some embodiments, a single reinforcing cord 866 extends continuously along the leaflet edge portions 816 of all leaflets and through the space below each commissure 810. In other embodiments, multiple reinforcing cords 866 may be used, with one reinforcing cord secured to the leaflet edge portions of each leaflet. When multiple reinforcing cords 866 are used, the end of each cord may be connected (e.g., by tying or knotting) to the adjacent end of another cord. For example, the adjacent ends of two cords may be connected to each other in the space below the commissures.

[0139] 69, 72, and 73 illustrate the connection of a connecting skirt 860 to a frame 12 according to one embodiment. As shown, the connecting skirt may be sutured to the struts 22 of the frame to form a diagonal line extending from the commissures 810 to the inflow end of the frame. In certain embodiments, one or both layers 864a, 864b of the connecting skirt may be secured to the intersections 856 (FIG. 71) with individual stitches 872 and additional overlock stitches 874 formed along the length of the strut 22 between two intersections 856. Each overlock stitch 874 may extend around the strut 22 through the edge portion 816 and multiple times along the length of the strut. The overlock stitches 874 may optionally extend through the leaflet edge portion 816, as shown in FIG. 69.

[0140] In alternative embodiments, the leaflet edge portions 816 of the leaflets 814 may be attached to the frame and / or inner layer 804 of the sealing member utilizing any of the techniques described herein. For example, any of the techniques or configurations described above with respect to Figures 10-12B or 14-32 may be used to attach the leaflets 814 to the frame 12 with or without the reinforcing cords 866.

[0141] As discussed above in connection with the embodiment shown in FIGS. 33-37 , the folded lower tabs 818 help reinforce the connection between the leaflet edge portion 816 of the leaflet and the frame along the upper section of the leaflet edge portion adjacent the commissure 810. The folded lower tabs 304 also shift the bending axis of the upper section of the leaflet edge portion inward and away from the inner surface of the frame, preventing or minimizing contact between the leaflet and the frame in the area below the commissure. In the illustrated embodiment, each lower tab 818 forms one additional layer of leaflet material on the upper (outflow) surface of the leaflet. In alternative embodiments, each lower tab 818 may be configured to shift the bending axis of the leaflet below the commissure further away from the inner surface of the frame by forming multiple additional layers of leaflet material on the upper surface of the leaflet, such as two, three, or four layers.

[0142] The side edges 819 between the lower tabs 818 and the upper tabs 820 may remain unattached to the frame of the prosthetic valve, as best shown in FIG. 67 and as previously described in connection with the configuration shown in FIG. 1C . As previously described, the unattached side edges 819 allow for greater axial elongation or stretching of the leaflets when the prosthetic valve is compressed and greater radial elongation or stretching of the leaflets when the prosthetic valve is expanded. During diastole, adjacent side edges 819 may abut one another to prevent retrograde blood from flowing between the side edges 819. During systole, adjacent side edges 819 may separate from one another to allow antegrade blood to flow between the side edges 819, helping to flush blood away from the area below the commissures 810.

[0143] After the leaflet assembly (leaflets 814 and connecting skirt 860) is attached to the frame, the sealing member 802 may be positioned over and attached to the frame as described above in connection with Figures 60-64. The triangular-shaped portion 808 of the inner layer 804 of the sealing member may be sutured with sutures 872 to the struts 22 of the frame and / or to one or both layers 864a, 864b of the connecting skirt 860 (see Figure 69).

[0144] 79-80 illustrate another embodiment of a prosthetic valve 900. The prosthetic valve 900 may be similar to the prosthetic valve 10 described above, except for the configuration of the sealing member. The prosthetic valve 900 in the illustrated embodiment includes a sealing member 901 including a first layer 902 and a second layer 904, both of which are mounted on the exterior of the frame 12. The first layer 902 includes a plurality of diamond-shaped portions 908 interconnected at an upper (outflow) end. The second layer 904 includes a plurality of triangular portions 910 interconnected at a lower (inflow) end. The triangular portions 910 are circumferentially aligned with the commissures 906 of the prosthetic valve and are interspersed among the diamond-shaped portions 908, which are circumferentially aligned with the valve leaflets 20. As shown, the diamond-shaped portion 908 and the triangular-shaped portion 910 may overlap each other to some extent near the commissures 906 .

[0145] The triangular-shaped portion 910 generally corresponds to the shape of the space between adjacent leaflets 20. The lower (inflow) end of the second layer 904 may be secured (e.g., with sutures) to the inflow end of the frame. The lower edge portion 102 of the leaflet 20 may be connected to the frame 12, such as with a connecting skirt 100, as previously described, which may pass through the cells of the frame and be secured (e.g., with sutures) to the sides of the triangular-shaped portion 910. In this manner, the triangular-shaped portion 910 prevents antegrade blood from flowing outward through the cells of the frame. The triangular-shaped portion 910, in combination with the diamond-shaped portion 908, may also engage surrounding tissue to help seal the prosthetic valve and prevent paravalvular regurgitation.

[0146] The first layer 902 may be secured to the frame 12 (e.g., with sutures) at the inflow end of each diamond-shaped portion 908 and at intersections 912 where the diamond-shaped portions 908 are interconnected along the outflow edge of the first layer. The diamond-shaped portions 908 are configured to extend radially away from the frame to engage and seal to surrounding tissue when the prosthetic valve is deployed. The outflow edge of the first layer 902 between the intersections 912 may remain unattached to the frame to receive retrograde blood between the first layer 902 and the frame. In some embodiments, the diamond-shaped portions 908 are configured to form an annular wavy shape around the exterior of the frame, as shown in FIG. 67 . Also, in some embodiments, the outflow edge of the first layer 902 may be secured to the frame (e.g., with sutures) at locations 914 between the intersections 912 to induce the first layer 902 to assume the wavy shape when the prosthetic valve is expanded.

[0147] In the illustrated embodiment, the first layer has diamond-shaped portions and the second layer has triangular-shaped portions, although other shapes are possible. For example, the first and second layer portions 908, 910 can be square, oval, rectangular, circular, or a combination of one or more of these shapes.

[0148] In alternative embodiments, the portions 908 of the first layer 902 can be separate pieces of material that are not interconnected. Similarly, the portions 910 of the second layer 904 can be separate pieces of material that are not interconnected. For example, FIGS. 81-82 show a prosthetic valve 1000 including sealing members in the form of alternating diamond-shaped portions 1002 and triangular-shaped portions 1004 positioned around the exterior of the frame. The diamond-shaped portions 1002 can be circumferentially aligned with the leaflets 20, and the triangular-shaped portions 1004 can be circumferentially aligned with the commissures 1006 of the leaflets. Each portion 1002, 1004 can be a separate piece of material that is sutured or otherwise secured to the frame 12 at the inflow and outflow ends. The diamond-shaped portions 1002 and triangular-shaped portions 1004 can extend away from the frame 12 and engage surrounding tissue when the prosthetic valve is expanded.

[0149] FIGS. 83-84 illustrate another embodiment of a prosthetic valve 1100. The prosthetic valve 1100 may include a sealing member 1102 attached to a frame 12 as described above in connection with the embodiment of FIGS. 60-63. The prosthetic valve 1100 may include leaflets 1114 interconnected at their outflow ends to form commissures 1110 that are attached to cells at the outflow end of the frame. The commissures 1110 may be formed by folding the commissure tabs of the leaflets and securing them to commissure attachment members 1112, which are then attached to the frame. Each leaflet 1114 may have an inferior or leaflet edge portion 1116 that is folded upward toward the outflow end of the frame 12 as previously described and secured to the frame using respective connecting skirts 1118 as described above in connection with FIGS. 69-73. Any other technique for attaching the leaflet edge portions to the frame disclosed herein may also be used.

[0150] 85-86 illustrate a commissure 1110 formed from two leaflets 1114. As shown, each leaflet may have commissure tabs folded to form a first layer 1120, a second layer 1122, and a third layer 1124. A reinforcing member 1126 may be positioned between the second layer 1122 and the third layer 1124. The commissure attachment member 1112 may be folded to form a central portion 1128, two side flaps 1130, and two pairs of folded layers 1132, 1134 that extend radially parallel to the third layer 1124 of the leaflet. The leaflet layers 1120, 1122, 1124 and the layers 1132, 1134 of the commissure attachment member 1112 may be secured together by one or more sutures 1136 and 1138. Each suture 1136, 1138 may form multiple parallel stitches that extend through all of these layers. As shown in FIG. 86, the suture 1136 may form a stitch that extends across the upper edges of the leaflet layers 1120, 1122, 1124. The side flaps 1130 may be sutured to the struts 22 of the frame as shown in FIGS. 72 and 77.

[0151] As shown in Figure 85, each leaflet may have opposing concave side edges 1140 below each commissure that may remain unattached to the frame to promote blood flow in the areas below the commissures, as previously described. Each leaflet also has opposing lower tabs 1142 (Figure 84) similar to lower tabs 818 of prosthetic valve 800. Reinforcing cords, such as reinforcing cord 866, may be secured to leaflet edge portions 1116 of the leaflets, as described above in connection with prosthetic valve 800.

[0152] Any of a variety of delivery techniques can be utilized to deliver any of the prosthetic heart valves disclosed herein. In a retrograde approach, the prosthetic valve can be mounted in radial compression along the distal end portion of a delivery catheter, and the delivery catheter and prosthetic valve can be advanced through the aorta to the native aortic valve. Once positioned within the native aortic valve, the prosthetic valve can be expanded, such as by inflation of a balloon or another expansion device.

[0153] As mentioned above, any of the prosthetic valves disclosed herein can be configured to be self-expanding or can be expandable by applying an expansion force with a balloon or any type of expansion mechanism. An example of a delivery catheter having an inflatable balloon for implanting a plastically expandable prosthetic heart valve (which can be used to implant any of the prosthetic valves disclosed herein) is disclosed in U.S. Patent Application Publication No. 2017 / 0065415. An example of a delivery catheter that can be used to deliver a self-expanding prosthetic heart valve (which can be used to implant any of the prosthetic valves disclosed herein) is disclosed in U.S. Patent Application Publication No. 2014 / 0343670.

[0154] Exemplary Systems and Methods for Sizing and Implanting a Prosthetic Heart Valve The prosthetic heart valves disclosed herein can be manufactured in a variety of sizes to accommodate variations in patients' natural anatomical structures. The "size" of a prosthetic heart valve can correspond to its nominal expanded diameter. For example, in some embodiments, a prosthetic heart valve configured for native aortic valve implantation can be manufactured in sizes of 20 mm, 23 mm, 26 mm, and 29 mm. In other embodiments, the prosthetic heart valve can be manufactured in a variety of other sizes.

[0155] Some prosthetic heart valves are configured so that each valve size can be expanded (e.g., using a balloon) to a range of diameters. For example, a prosthetic heart valve having a nominal diameter of 23 mm (also referred to as a "23 mm valve") can be expanded to a diameter in the range of 20-26 mm in some embodiments, or to a diameter in the range of 22-24 mm in other embodiments. Herein, a prosthetic heart valve having an expanded diameter less than its nominal diameter is referred to as "underexpanded" or "underdeployed." For example, a 23 mm valve expanded to a 22 mm diameter is underexpanded. Herein, a prosthetic heart valve expanded to its nominal diameter is referred to as "nominally expanded" or "nominally deployed." For example, a 23 mm valve expanded to a 23 mm diameter is nominally deployed. Herein, a prosthetic heart valve having an expanded diameter greater than its nominal diameter is referred to as "overexpanded" or "overdeployed." For example, a 23 mm valve expanded to a 24 mm diameter is overexpanded.

[0156] Prior to or as part of the delivery procedure, a prosthetic heart valve size must be selected. Prosthetic heart valve size can affect multiple factors, including the resistance of the prosthetic heart valve to migration relative to the native annulus and / or the impact of the prosthetic heart valve on native tissue. For example, an overly small prosthetic heart valve may migrate from the annulus and cause embolism. An overly large prosthetic heart valve may damage native tissue if fully expanded or may not function properly if significantly underexpanded (e.g., the leaflets may not open fully and / or may contact the frame as they open).

[0157] The size of a prosthetic heart valve can also affect blood flow characteristics (also called "hemodynamics"), such as the pressure gradient across the prosthetic heart valve. The pressure gradient across the prosthetic heart valve is directly proportional to the amount of force required to move blood from one side of the valve (e.g., the left ventricle) to the other (e.g., into the aorta). Therefore, a lower pressure gradient across the prosthetic heart valve is desirable because it can reduce the amount of work the heart must do to ensure adequate circulation.

[0158] The selection of a prosthetic heart valve size may involve multiple factors, including the size of the patient's native annulus, the severity of calcification, other anatomical factors, etc. FIG. 87 shows a flow chart of an example method 1200 that may be utilized when selecting a prosthetic heart valve size. The first process is to determine the patient's native annulus area and / or native annulus diameter (see process block 1210). This may be accomplished, for example, by scanning the patient's native annulus using various imaging techniques, including computed tomography ("CT"), and measuring those images to obtain the native annulus area. This area may be used to determine the diameter. The native annulus area and / or native annulus diameter may also be determined using other measurement techniques, including inserting a measuring device (sometimes referred to as a "valve sizer") into the native annulus and measuring the native annulus area and / or native annulus diameter. The native annulus area and / or native annulus diameter may be measured, for example, at the basal ring of the aortic valve during ventricular systole.

[0159] A prosthetic heart valve expanded to a specific size (e.g., 23 mm) can be used for a range of native annular areas / diameters without causing migration or tissue damage. In some embodiments, the disclosed prosthetic heart valves can be "oversized" to the native annulus by up to 40% and "undersized" to the native annulus by up to 10%. In certain embodiments, the disclosed prosthetic heart valves can be oversized to the native annulus by up to 20% and undersized to the native annulus by up to 5%. "Oversized" means that the expanded diameter of the prosthetic heart valve exceeds the determined native annular diameter. "Undersized" means that the expanded diameter of the prosthetic heart valve is less than the determined native annular diameter. Undersizing can also be indicated using negative numbers, and oversizing can be indicated using positive numbers. For example, a prosthetic heart valve that is undersized by 10% can be indicated as "-10%," and a prosthetic heart valve that is oversized by 10% can be indicated as "10%."

[0160] The prosthetic heart valves disclosed herein can be implanted within a relatively wide range of annular sizes and / or within a range of expanded diameters for a particular valve size. For example, a 20 mm valve can be deployed (e.g., under-deployed, nominally-deployed, and / or over-deployed) within a native annulus having a diameter ranging from 16 mm to 24 mm, or in some embodiments, within a native annulus having a diameter ranging from 18.3 mm to 20.5 mm. In another example, a 23 mm valve can be deployed (e.g., under-deployed, nominally-deployed, and / or over-deployed) within a native annulus having a diameter ranging from 19 mm to 27 mm, or in some embodiments, within a native annulus having a diameter ranging from 20.5 mm to 27 mm. In another example, a 26 mm valve can be deployed (e.g., under-deployed, nominally deployed, and / or over-deployed) in a native annulus having a diameter in the range of 23 mm to 29 mm, or in some embodiments, can be deployed (e.g., under-deployed, nominally deployed, and / or over-deployed) in a native annulus having a diameter in the range of 23.5 mm to 27.2 mm. In another example, a 29 mm valve can be deployed (e.g., under-deployed, nominally deployed, and / or over-deployed) in a native annulus having a diameter in the range of 25 mm to 33 mm, or in some embodiments, can be deployed (e.g., under-deployed, nominally deployed, and / or over-deployed) in a native annulus having a diameter in the range of 25.1 mm to 30.8 mm.

[0161] This versatility may result in more than one prosthetic heart valve corresponding to the determined native valve annulus area / diameter (see decision block 1230). For example, two valve sizes (e.g., a 23 mm valve and a 26 mm valve) may be used to measure the area / diameter of the 408 mm prosthetic heart valve. 2and a diameter of 22.8 mm. The 23 mm valve size can be nominally expanded (i.e., to a 23 mm diameter) or overexpanded (i.e., to a 24 mm diameter) to accommodate this native valve size. If multiple valve sizes and / or deployed diameters are available, the hemodynamic characteristics (e.g., pressure gradient) can be analyzed for each valve (see process block 1240). The desired valve size and / or diameter can be selected based on this analysis (see process block 1250). If only one prosthetic heart valve size and diameter corresponds to the determined native valve annulus area / diameter, that prosthetic heart valve is selected (see decision block 1260).

[0162] 88 shows a flow chart of another example method 1300 that may be utilized in selecting a prosthetic heart valve size and / or deployed diameter. This method 1300 may include determining a native annulus area and / or native annulus diameter (see process block 1310), determining which prosthetic heart valve sizes and / or deployed diameters correspond to the determined native annulus area and / or native annulus diameter (see process block 1320), and determining whether two or more prosthetic heart valve sizes and / or deployed diameters correspond to the determined native annulus area and / or native annulus diameter. Processes 1310, 1320, and 1330 of method 1300 may be performed similarly to the manner in which processes 1210, 1220, and 1230 of method 1200, respectively, are performed.

[0163] If multiple prosthetic heart valve sizes and / or diameters correspond to the determined native annulus area and / or native annulus diameter, the method may include determining which prosthetic heart valve has the largest size and / or largest deployed diameter (see process block 1340). The prosthetic heart valve having the largest size and / or largest deployed diameter may then be selected (see process block 1350). In many instances, the prosthetic heart valve having the largest size and / or largest deployed diameter will have the lowest pressure gradient and therefore will be the desired prosthetic heart valve. Thus, the disclosed prosthetic heart valves and methods may provide very good hemodynamics when the prosthetic heart valve is oversized relative to the native annulus and underexpanded relative to the prosthetic heart valve's nominal diameter.

[0164] In some embodiments, the selected prosthetic heart valve has a nominal diameter that is up to 40% larger (i.e., oversized), in other cases up to 30% larger, in other cases up to 20% larger, and in other cases up to 10% larger than the native annulus diameter of the native valve annulus. In some embodiments, the selected prosthetic heart valve has a nominal diameter that is in the range of 5-40% larger, in other cases up to 5-35% larger, in other cases up to 5-30% larger, in other cases up to 5-25% larger, in other cases up to 5-20% larger, in other cases up to 5-15% larger, and in other cases up to 5-10% larger than the native annulus diameter of the native valve annulus. In some embodiments, the selected prosthetic heart valve has a nominal diameter that is in the range of 10-40% larger, in other cases in the range of 10-35% larger, in other cases in the range of 10-30% larger, in other cases in the range of 10-25% larger, in other cases in the range of 10-20% larger, and in other cases in the range of 10-15% larger than the native annulus diameter of the native valve annulus. In some embodiments, the selected prosthetic heart valve has a nominal diameter that is in the range of 15-40% larger, in other cases in the range of 15-35% larger, in other cases in the range of 15-30% larger, in other cases in the range of 15-25% larger, and in other cases in the range of 15-20% larger than the native annulus diameter of the native valve annulus. In some embodiments, the selected prosthetic heart valve has a nominal diameter that is in the range of 20-40% larger, in other cases in the range of 20-35%, in other cases in the range of 20-30%, and in other cases in the range of 20-25% larger than the native annulus diameter of the native valve annulus. In some embodiments, the selected prosthetic heart valve has a nominal diameter that is in the range of 25-40% larger, in other cases in the range of 25-35%, and in other cases in the range of 25-30% larger than the native annulus diameter of the native valve annulus. In some embodiments, the selected prosthetic heart valve has a nominal diameter that is in the range of 30-40% larger, in other cases in the range of 30-35% larger than the native annulus diameter of the native valve annulus.In some embodiments, the selected prosthetic heart valve has a nominal diameter that is 35-40% larger than the native annulus diameter of the native valve annulus. As used herein, the term "within the range of x-y%" refers to the numbers X and y, as well as all numbers between x and y. For example, the range of 5-10% includes 5%, 6%, 7%, 8%, 9%, and 10%, as well as non-integer values ​​such as 5.25%, 6.1%, 7.67%, 8.8%, and 9.15%, and subranges such as 5-7% and 6.5-9.75%.

[0165] In some embodiments, the selected prosthetic heart valve may be under-expanded (or under-deployed) by up to 10%, in other cases by up to 9%, in other cases by up to 8%, in other cases by up to 7%, in other cases by up to 6%, in other cases by up to 5%, in other cases by up to 4%, in other cases by up to 3%, in other cases by up to 2%, and in other cases by up to 1% compared to the nominal diameter. In certain embodiments, the selected prosthetic heart valve may be underexpanded by 1-10% relative to the nominal diameter, in other cases within a range of 1-9%, in other cases within a range of 1-8%, in other cases within a range of 1-7%, in other cases within a range of 1-6%, in other cases within a range of 1-5%, in other cases within a range of 1-4%, in other cases within a range of 1-3%, and in other cases within a range of 1-2%, as well as non-integer amounts within these ranges and subranges (e.g., 0.1-4%, 2-8%, 3-5%, etc.).

[0166] If only one prosthetic heart valve and / or deployed diameter corresponds to the determined native annulus area and / or native annulus diameter, the prosthetic heart valve corresponding to that range may be selected (see process block 1360).

[0167] In some embodiments, method 1200 and / or method 1300 further include determining which valve model corresponds to the determined native annulus area and / or native annulus diameter. For example, a manufacturer may have multiple models, such as "Valve A" and "Valve B." Each valve model is offered in multiple sizes (e.g., 20 mm, 23 mm, 26 mm, 29 mm), which can be expanded to a certain deployed diameter (e.g., 23 mm for a 23 mm valve) or to a range of diameters (e.g., 21-24 mm for a 23 mm valve). Method 1200 may include analyzing the hemodynamic characteristics of each model, comparing the characteristics of each model to the characteristics of other models, and selecting a model, size, and / or expanded diameter based on the analysis and comparison.

[0168] As an example, 408 mm 2 For a native valve having an area of ​​22.8 mm and a diameter of 22.8 mm, two valve models, namely, valve A and valve B, can be used. For valve A, two valve sizes, namely, a 23 mm valve or a 26 mm valve, can be used. Also, the 23 mm size valve A can be nominally expanded to a 23 mm diameter or overexpanded to a 24 mm diameter. The 26 mm size valve A can be underexpanded to 25 mm. For valve B, one valve size and expanded diameter, namely, 23 mm, can be used for these native anatomical dimensions. The hemodynamic properties of each possible configuration can be analyzed and compared.

[0169] In some examples, the methods described above (including methods 1200, 1300) may be incorporated into a software application ("app") for a computing device (e.g., a desktop computer, a laptop computer, a tablet, a smartphone, etc.).

[0170] In certain embodiments, the app may be configured to display a graphical user interface (“GUI”) 1400 on a display of a computing device, as shown in FIG. 89. This GUI 1400 may include a data entry window 1402 configured to receive a determined native annulus area, which may be entered by a user or received from another computing device or database. Referring to FIG. 90, upon receiving the native annulus area, the software may be configured to perform method 1200 and display the entered native annulus area (see display window 1404), the determined native annulus diameter (see display window 1406), available prosthetic heart valve options (see display window 1408), and hemodynamic data for the available prosthetic heart valves (see display windows 1410, 1412, 1414).

[0171] In another embodiment, the app may be configured to display a GUI 1500 on the display of a computing device as shown in FIG. 91. The GUI 1500 may include a data entry window 1502 configured to receive a determined native annulus area, which may be entered by a user or received from another computing device or database. Referring to FIG. 92, upon receiving the native annulus area, the software performs method 1300 and calculates the input native annulus area (e.g., 531 mm). 2) (see display window 1504), determined native valve annulus diameter (e.g., 26.0 mm) (see display window 1506), proposed prosthetic heart valve model and size (e.g., Valve A-29 mm) (see display window 1508), proposed valve expanded diameter (e.g., 27.8 mm) (see display window 1510), proposed valve hemodynamic data (e.g., 3.8 mmHg) (see display window 1512), and delivery device information including inflated balloon diameter (e.g., 28.3 mm) (see display window 1514) and / or balloon inflation volume (e.g., 26 mL) (see display window 1516).

[0172] Further Examples of Systems and Methods for Sizing and Implanting a Prosthetic Heart Valve The following is an enumerated list of further examples of the techniques of this disclosure.

[0173] 1. A method for selecting a prosthetic heart valve, comprising: determining the native annulus area of ​​the native heart valve by obtaining an image of the native annulus and measuring the image; determining which prosthetic heart valve among a plurality of prosthetic heart valves corresponds to the determined native annulus area; analyzing hemodynamic data for each prosthetic heart valve among the plurality of prosthetic heart valves; and selecting a desired prosthetic heart valve from among the plurality of prosthetic heart valves based on the analyzed hemodynamic data.

[0174] 2. The method of example 1, wherein the hemodynamic data includes a pressure gradient across the prosthetic heart valve, the pressure gradient being the blood pressure at the outflow end of the prosthetic heart valve divided by the blood pressure at the inflow end of the prosthetic heart valve.

[0175] 3. The method of either Example 1 or Example 2, wherein the selected prosthetic heart valve has the lowest pressure gradient of the prosthetic heart valve corresponding to the determined native annulus area.

[0176] 4. The method of any one of Examples 1-3, wherein the selected prosthetic heart valve has a maximum nominal diameter of the prosthetic heart valve that corresponds to the determined native annulus area.

[0177] 5. The method of any one of Examples 1-4, wherein the selected prosthetic heart valve has a maximum expanded diameter of the prosthetic heart valve that corresponds to the determined native annulus area.

[0178] 6. The method of any one of Examples 1-5, further comprising determining a diameter of the native annulus, wherein the selected prosthetic heart valve has an expanded diameter that is smaller than the determined diameter of the native annulus.

[0179] 7. The method of Example 6, wherein the expanded diameter is within the range of 0-10% less than the determined diameter of the native annulus.

[0180] 8. The method of Example 6, wherein the expanded diameter is within the range of 0-5% less than the determined diameter of the native annulus.

[0181] 9. The method of any one of Examples 1-8, further comprising determining a diameter of the native annulus, wherein the selected prosthetic heart valve has an expanded diameter greater than the determined diameter of the native annulus.

[0182] 10. The method of example 9, wherein the expanded diameter is within the range of 0-40% greater than the determined diameter of the native annulus.

[0183] 11. The method of example 9, wherein the expanded diameter is within the range of 0-20% greater than the determined diameter of the native annulus.

[0184] 12. The method of any one of Examples 1-11, wherein the prosthetic heart valve is balloon expandable.

[0185] 13. The method of any one of Examples 1-11, implemented as an application on a computing device.

[0186] 14. The method of any one of Examples 1-13, further comprising implanting the selected prosthetic heart valve within the native valve annulus.

[0187] 15. A method of implanting a prosthetic heart valve, comprising: Determining the diameter of the native heart valve annulus; advancing a prosthetic heart valve through a patient's blood vessel to a native heart valve annulus, the prosthetic heart valve being in a radially collapsed configuration; a frame having an inflow end and an outflow end, the frame being radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration; and a valve structure including a plurality of valve leaflets mounted within a frame and regulating blood flow through the frame, each of the valve leaflets including opposing upper tabs on either side of the leaflet, opposing lower tabs on either side of the leaflet located below the upper tabs, and a leaflet edge portion extending between the lower tabs, the leaflet edge portions being fixed relative to the frame, each upper tab mating with an adjacent upper tab of an adjacent leaflet to form a plurality of commissures fixed relative to the frame, and each lower tab being folded to form at least one folded layer along the leaflet edge portion of the respective leaflet; and Expanding the prosthetic heart valve from a radially collapsed configuration to a radially expanded configuration, wherein in the radially expanded configuration, the prosthetic heart valve has an outer diameter that is greater than the determined diameter of the native heart valve annulus. A method comprising:

[0188] 16. The method of example 15, wherein the outer diameter of the prosthetic heart valve in the radially expanded configuration is in the range of 5-40% greater than the determined diameter of the native heart valve annulus.

[0189] 17. The method of example 15, wherein the outer diameter of the prosthetic heart valve in the radially expanded configuration is in the range of 10-20% greater than the determined diameter of the native heart valve annulus.

[0190] 18. The method of example 15, wherein the outer diameter of the prosthetic heart valve in the radially expanded configuration is smaller than the nominal diameter of the prosthetic heart valve.

[0191] 19. A method of implanting a prosthetic heart valve, comprising: determining the native annulus area and the native annulus diameter of the native heart valve by obtaining an image of the native annulus of the native heart valve, obtaining measurements of the native annulus from the image, and calculating the area and diameter of the native annulus based on the measurements; determining which prosthetic heart valve among a plurality of prosthetic heart valves corresponds to the determined native annulus area; analyzing hemodynamic data for each prosthetic heart valve among the plurality of prosthetic heart valves; selecting a prosthetic heart valve from the plurality of prosthetic heart valves based on the analyzed hemodynamic data, the selected prosthetic heart valve having a nominal diameter that is up to 40 percent larger than the determined native annulus diameter; compressing the selected prosthetic heart valve into a radially collapsed configuration in which the selected prosthetic heart valve has a first diameter that is smaller than the nominal diameter; Positioning the selected prosthetic heart valve within the native annulus; Expanding the selected prosthetic heart valve from the radially collapsed configuration to a radially expanded configuration in which the prosthetic heart valve has a second diameter that is at most less than 10 percent smaller than the nominal diameter and greater than the first diameter; A method comprising:

[0192] 20. The method of example 19, wherein the image is acquired using computed tomography.

[0193] 21. One or more computer-readable storage media comprising instructions that can be executed by a computer, the instructions comprising: receiving a user-entered measurement of the native heart valve annulus area; calculating an area-derived native annulus diameter based on the received native annulus area measurements; Analyzing the hemodynamic characteristics of multiple prosthetic heart valves determining a proposed prosthetic heart valve from among a plurality of prosthetic heart valves; determining a proposed expanded diameter of the proposed prosthetic heart valve; Determine the expected pressure gradient across a proposed prosthetic heart valve One or more computer-readable storage media configured to:

[0194] Examples of Computing Devices 93 illustrates a general example of a suitable computing system 1600 in which the described innovations may be implemented. The computing system 1600 is not intended to suggest any limitation as to the scope of use or functionality, as these innovations may be implemented in a variety of general-purpose or special-purpose computing systems. For example, the computing system 1600 may be used to implement hardware and software.

[0195] Referring to FIG. 93, a computing system 1600 includes one or more processing units 1610, non-volatile memory 1620, 1615, and memory 1625. In FIG. 93, this basic configuration 1630 is included within the dashed line. The processing units 1610, 1615 execute computer-executable instructions, including instructions for generating a shape model, identifying fiducials in an image, and / or aligning an output device to a product as disclosed herein. The processing units can be general-purpose central processing units (“CPUs”), processors in application-specific integrated circuits (“ASICs”), or any other type of processor. In multi-processing systems, multiple processing units execute computer-executable instructions to increase processing power. For example, FIG. 93 shows a central processing unit 1610 and a graphics processing unit (“GPU”) or co-processing unit 1615. The tangible memory 1625 may be volatile memory (e.g., registers, cache, RAM), non-volatile memory (e.g., ROM, EEPROM, flash memory, etc.), or some combination of both accessible by the processing unit. The memory 1625 stores software 1680 in the form of computer-executable instructions suitable for execution by the processing unit, implementing one or more innovations described herein.

[0196] The computing system may have additional features. For example, computing system 1600 includes storage 1640, one or more input devices 1650, one or more output devices 1660, and one or more communication connections 1670. An interconnection mechanism (not shown), such as a bus, controller, or network, interconnects the components of computing system 1600. Typically, operating system software (not shown) provides an operating environment for other software executing within computing system 1600 and coordinates the operation of the components of computing system 1600.

[0197] Tangible storage 1640 may be removable or non-removable and includes magnetic disks, magnetic tapes or cassettes, CD-ROMs, DVDs, or any other medium that may be used to store information and that is accessible within computing system 1600. Storage 1640 stores instructions for software 1680 that implements one or more innovations described herein.

[0198] Input device(s) 1650 may be a touch input device such as a keyboard, mouse, pen, or trackball, an audio input device, a scanning device, a microphone, buttons, pedals, or another device that provides input to computing system 1600. In the case of video encoding, input device(s) 1650 may be a camera with an image sensor, a video card, a TV tuner card, or similar device that accepts video input in analog or digital form, or a CD-ROM, CD-RW, DVD, or Blu-Ray that allows video samples to be read into computing system 1600. Output device(s) 1660 may be a display, printer, speakers, CD writer, or another device that provides output from computing system 1600.

[0199] The communications connection(s) 1670 enable communication to another computing entity over a communications medium (e.g., a connected network) that conveys information such as computer-executable instructions, compressed image information, video, or other data in a modulated data signal. The communications connection(s) 1670 may include, but are not limited to, wired connections (e.g., Megabit or Gigabit Ethernet, Infiniband, Fibre Channel over electrical or optical fiber connections), as well as wireless technologies (e.g., Bluetooth, WiFi (IEEE 802.11a / b / n), WiMax, RF connections over cellular, satellite, laser, infrared, radio frequency connections), and other suitable communications connections for providing network connectivity to public agents, bridges, and agent data consumers. In a virtual host environment, the communications connection(s) may be a virtual network connection implemented by a virtual host.

[0200] Some embodiments of the disclosed methods may be performed using computer-executable instructions that implement all or a portion of the disclosed techniques in a computing cloud 1690. For example, the disclosed computer-readable instructions may be executed by a processor located in the computing environment 1630, or the disclosed computer-readable instructions may be executed by a server located in the computing cloud 1690.

[0201] Computer-readable media are any available media that can be accessed within computing environment 1600. By way of example, and not limitation, with this computing environment 1600, computer-readable media comprise memory 1620 and / or storage 1640. As will be readily understood, the term computer-readable storage media includes media for data storage, such as memory 1620 and storage 1640, but does not include transmission media, such as modulated data signals or other transitory signals.

[0202] These innovations may be described in the general context of computer-executable instructions, such as those contained in program modules, being executed on a target real or virtual processor in a computing system. Generally, program modules include routines, programs, libraries, objects, classes, components, data structures, etc. that perform particular tasks or implement particular data types. The functionality of the program modules may be combined or split between program modules as desired in various embodiments. Computer-executable instructions for program modules may be executed in a local or distributed computing system.

[0203] Examples of Mobile Computing Devices 94 is a block diagram of a mobile computing device 1700 capable of implementing the techniques and solutions described herein. The mobile device 1700 includes various optional hardware and software components indicated generally at 1702. Generally, components 1702 within the mobile device 1700 can communicate with any other component of the device, although not all connections are shown for ease of illustration. The mobile device 1700 can be any of a variety of computing devices (e.g., a mobile phone, a smartphone, a handheld computer, a laptop computer, a notebook computer, a tablet device, a slate device, a media player, a personal digital assistant (PDA), a camera, a video camera, etc.) and can enable wireless two-way communication using one or more mobile communication networks 1704, such as Wi-Fi, cellular, or satellite networks.

[0204] The illustrated mobile device 1700 includes a controller or processor 1710 (e.g., a signal processor, microprocessor, ASIC, or other control and processing logic) for performing tasks such as signal coding, data processing, input / output processing, power control, and / or other functions. An operating system 1712 controls the allocation and use of components 1702 and support for one or more application programs 1714, such as a valve sizing tool, that implement one or more of the innovative technical features described herein. In addition to valve sizing software, these application programs may include typical mobile computing applications (e.g., calling applications, email applications, calendars, contact managers, web browsers, messaging applications), and / or any other computing application.

[0205] The illustrated mobile device 1700 includes memory 1720. Memory 1720 may include non-removable memory 1722 and / or removable memory 1724. Non-removable memory 1722 may include RAM, ROM, flash memory, a hard disk, or other well-known memory storage technologies. Removable memory 1724 may include flash memory, a subscriber identity module (SIM) card, such as those well-known in Global System for Mobile Communications (GSM) communication systems, or other well-known memory storage technologies such as "smart cards." Memory 1720 may be used to store data and / or code for executing operating system 1712 and application programs 1714. Examples of data may include web pages, text, images, audio files, video data, or other data sets transmitted to or received from one or more network servers or other devices over one or more wired or wireless networks. The memory 1720 may be used to store subscriber identifiers, such as an International Mobile Subscriber Identity (IMSI), and device identifiers, such as an International Mobile Equipment Identity (IMEI), which may be transmitted to a network server to identify users and devices.

[0206] The mobile device 1700 may support one or more input devices 1730, such as a touchscreen 1732 (e.g., capable of capturing finger tap input, finger gesture input, or keystroke input in the case of a virtual keyboard or keypad), a microphone 1734 (e.g., capable of capturing voice input), a camera 1736 (e.g., capable of capturing still and / or video images), a physical keyboard 1738, buttons, and / or a trackball 1740, and one or more output devices 1750, such as a speaker 1752 and a display 1754. Other possible output devices (not shown) may include piezoelectric output devices or other tactile output devices. Some devices may serve more than one input / output function. For example, the touchscreen 1732 and display 1754 may be combined into a single input / output device.

[0207] The mobile device 1700 may provide one or more natural user interfaces. For example, the operating system 1712 or applications 1714 may include voice recognition software as part of a voice user interface that allows a user to operate the device 1700 with voice commands. For example, a user's voice commands may be used to execute inputs to a valve sizing tool.

[0208] A wireless modem 1760 may be coupled to one or more antennas (not shown) and support bidirectional communication between the processor 1710 and external devices as is well known in the art. The modem 1760 is generally shown and may comprise, for example, a cellular modem for long-range communication with the mobile communications network 1704, a Bluetooth®-enabled modem 1764, or a Wi-Fi®-enabled modem 1762 for short-range communication with external Bluetooth®-equipped devices or a local wireless data network or local wireless router. The wireless modem 1760 is typically configured to communicate with one or more cellular networks, such as a GSM network for data and voice communications within a single cellular network, between cellular networks, or between mobile devices and the public switched telephone network (PSTN).

[0209] The mobile device 1700 may further comprise at least one input / output port 1780, a power source 1782, a satellite navigation system receiver 1784 such as a Global Positioning System (GPS) receiver, sensors 1786 such as an accelerometer, gyroscope, compass, or infrared proximity sensor for detecting the orientation and movement of the device 1700 and receiving gesture commands as input, a transceiver 1788 (for wirelessly transmitting analog or digital signals), and / or a physical connector 1790, which may be a USB port, an IEEE 17394 (FireWire) port, and / or an RS-232 port. The illustrated components 1702 are neither required nor all-inclusive, as any of the illustrated components may be omitted and other components may be added.

[0210] The mobile device 1700 can be part of an implementation in which various types of services (e.g., computing services) are provided by a computing "cloud." For example, a cloud can consist of a collection of computing devices, which can be centralized or distributed, that provide cloud-based services to various types of users and devices connected over a network such as the Internet. Some tasks (e.g., processing user input and displaying a user interface) may be performed on the local computing device (e.g., the connected device), while other tasks (e.g., storage of data to be used in later processing) may be performed in the cloud.

[0211] Although FIG. 94 illustrates a mobile device 1700, more generally, the techniques and solutions described herein can be implemented using devices with other screen characteristics and device form factors, such as a desktop computer, a television screen, or a device connected to a television (e.g., a set-top box or gaming console). Services can be provided by the cloud through a service provider or other online service provider. Thus, the valve sizing techniques and solutions described herein can be implemented using any of the connected devices as client computing devices. Similarly, any of the various computing devices within the cloud or service provider can act as server computing devices and deliver map data or other data to connected devices.

[0212] In view of the numerous possible embodiments to which the principles of the present disclosure may be applied, it should be recognized that these illustrated embodiments are examples only and should not be understood as limiting the scope of the claims. Rather, the scope of claimed subject matter is defined by the following claims and their equivalents. [Explanation of symbols]

[0213] 10 Artificial heart valves, artificial valves, valves 12 frames 14 Valve structure, valve leaflet structure 16 Component sealing member, sealing member 20 leaflets 22 Strut, frame strut 22a Strut 22b strut 24 cells 26 Inlet end 28 Outflow end 30 incoming edges 32 Commissure 34 Inner layer 36 Outer layer 36a Lower tapered wall section 36b Upper tapered wall section 36c Center Wall Section 38 Sutures 40 space 42 Aperture 44 Retrograde Blood 50 Intersection 52 Central section, central part 54 first longitudinal edge portion 56 second longitudinal edge portion 60 Commissure tab, tab 60a Radial extension layer, tab layer 60b Circumferentially extending layer 62 Sloped Edge 64 Joint Edge 66 inner edge 70 Outflow surface 80 tubular body 82 Upper part 84 Lower part 86 Radial bulge 90 tubular body 92 Cylindrical center section 94 flat upper part, upper part 96 Flat lower part 100 linked skirt 102 Lower edge portion, valve cusp edge portion, lower fan-shaped edge portion 104 Main Unit 106a Flap 106b Flap 108 stitches 109 Circular inner skirt 110a Folding part 110b Folding part 112 stitches 114 Bending axis 116 Diagonal Lines, Diagonal Columns 120 slit 124 First layer, first skirt layer 126 Second Layer 128 First leaflet layer 130 Second leaflet layer 132 stitches 134 Third Skirt Layer 136 Fourth Skirt Layer 138 Fifth Skirt Layer 140 Sixth Skirt Layer 142 stitches 144 stitches 146 stitches 150 First Skirt Layer 152 Second Skirt Layer 154 Third Skirt Layer 156 stitches 158 Fourth Skirt Layer 160 stitches 170 First Skirt Layer 172 Second Skirt Layer 174 Third Skirt Layer 176 Fourth Skirt Layer 178 stitches 180 stitches 182 stitches 184 stitches 186 Slit 190 Circular inner skirt 200 Reinforcement member, reinforcing suture 202 linked skirt 202a Outer skirt layer 202b Inner skirt layer 204 Inner longitudinal edge portion, inner edge portion 206 outer longitudinal edge portion, outer edge portion 208 stitches 210 Outer Skirt 212 stitches 216 Apex 218 Upper outer skirt 220 Lower outer skirt 222 stitches 230 Linked Skirt 232 Upper edge part, middle part upper edge part 234 Lower edge part 236 stitches 238 stitches 240 Contact area 250 loop stitches 252 Loop Stitch 254 Loop Stitch 300 Leaflet, second leaflet 302 Lower edge part, valve cusp edge part 304 Integrated lower tab, lower tab 306 Integrated upper tab, upper tab, commissure tab 306a first tab layer, tab portion, tab layer, first folding layer, folding tab layer, folding layer, tab portion, layer 306b Second tab layer, second folding layer 308 Horizontal folding line, folding line 310 first vertically extending reinforcing member, first reinforcing member 312 second vertically extending reinforcing member, second reinforcing member 314 stitches 316 Outer folding part 318 Inner folding part 320 Reinforcing member, third reinforcing member 322 Commissure attachment member 324 stitches 326 stitches 328 Commissure 330 Joints 332 Inner Edge 334 axes 338 Side Edge, Unattached Side Edge 340 Valve Leaflet 341 Top Tab 342 Vertical Folding Line 344 Vertical reinforcement members, reinforcement members 346 stitches 350 Reinforcement member 352 Commissure attachment member 354 stitches 400 leaflets 402 Lower edge part, edge part 404 Bottom Tab 406 Upper tab, commissure tab 408 Gap 410 Lower tab part 412 Upper tab portion, tab layer 414 Side tab part 416 Folding Line 418 Reinforcement member 420 horizontal folding line 422 Commissure attachment member 424 stitches 426 Outer folding part 428 Inner folding part 430 Commissure 432 stitches 434 Inner end 436 axes 438 Reinforcement members 440 stitches 500 leaflets 502 Lower edge part 504 Bottom Tab 506 Upper tab, commissure tab 508 Gap 510 Lower tab part 512 Upper tab part 514 Folding Line 516 Vertical Folding Line 518 First Layer 520 Second Layer 522 Third Layer 524 Fourth Layer 526 Reinforcement members 528 Commissure attachment member 530 Central outer part 532 Outer end section, end section 534 Side part 534a first material layer 534b second material layer 536 stitches 538 stitches 540 Side Extension Stitch 542 diagonal row stitches 544 Inner sleeve 544a First Part 544b Second part 546 Outer support member 548 Upper end 554 Reinforcement member 600 Artificial Valves 602 Sealing member 604 Inner layer 606 Outer layer 608 Triangular part 610 Upper edge part 612 Upper edge part 614 Space 700 Artificial Valves 702 Sealing member 704 Inner layer 705 Thin Strip 706 Outer layer 708 triangular part, triangular part 710 Upper edge part 714 Space 800 artificial valves 802 Sealing member 804 Inner layer 806 Outer layer 808 Triangular part 810 Commissure 812 Commissure attachment member 814 Valve Leaflet 816 Lower edge part, leaflet edge part 818 Lower Tab 819 Side Edge 820 Integrated upper tab, upper tab, commissure tab 820a First Tab Layer 820b Second Tab Layer 822 Lateral extension gap, recess 824 Folding Line 826 Vertical reinforcement, reinforcement, reinforcement member 828a first side portion 828b Second lateral part 830 central part 832 outer peripheral edge 834a first circumferentially extending layer 834b first radially extending layer 836a Second inner circumferentially extending layer 836b radially extending layer 838 Inner layer 840 middle class 842 Outer layer 844 stitches 846 Small gap 848 stitches 850 upper tab 852 Lower tab 854 apex 856 Intersection 860 linked skirt 860a central part 860b Side part 862 Slit 864a Folding layer 864b Folding layer 866 Reinforcing cords and reinforcing members 868 stitches 870 sutures 872 stitches 874 Sewing Stitch 900 Artificial Valves 901 Sealing member 902 First Layer 904 Second Layer 906 Commissure 908 First part, diamond-shaped part, section 910 Triangular part, section 912 Intersection 914 position 1000 artificial valves 1002 Diamond-shaped part 1004 Triangular part 1006 Commissure 1100 Artificial valve 1102 Sealing member 1110 Commissure 1112 Commissure attachment member 1114 Valve leaflet 1116 Valve leaflet edge 1118 each connected skirt 1120 First layer, valve leaflet layer 1122 Second Layer 1124 Third Layer 1126 Reinforcement member 1128 Central part 1130 Side flap 1132 Folding layer 1134 Folding Layer 1136 Sutures 1140 concave side edge 1142 Lower tab 1400 Graphical User Interface (GUI) 1402 Data Entry Window 1404 Display Window 1406 Display Window 1408 Display Window 1410 Display Window 1412 Display Window 1414 Display Window 1500 Graphical User Interface (GUI) 1502 Data Entry Window 1504 Display Window 1506 Display Window 1510 Display Window 1512 Display Window 1514 Display Window 1516 Display Window 1600 Computing System 1600 Computing Environment 1610 Processing Unit 1610 Central Processing Unit 1615 Processing unit, graphics processing unit or co-processing unit 1620 Non-volatile Memory 1625 Tangible Memory 1630 Basic Configuration, Computing Environment 1640 Tangible Storage 1650 input devices 1660 output device 1670 Communication connection part 1680 Software 1690 Computing Cloud 1700 Mobile Computing Devices 1702 Components 1704 Mobile communication network 1710 processor 1712 Operating System 1714 Applications, application programs 1720 memory 1722 Non-removable Memory 1724 Removable Memory 1730 Input Devices 1732 touchscreen 1734 Microphone 1736 Camera 1738 Physical Keyboard 1740 Trackball 1750 output device 1752 Speaker 1754 Display 1760 Wireless Modem 1762 Wi-Fi enabled modem 1764 Bluetooth modem 1780 input / output ports 1782 Power supply 1784 Satellite Navigation System Receiver 1786 Sensor 1788 Transceiver 1790 Physical Connector

Claims

[Claim 1] A method for selecting a prosthetic heart valve as described in the specification and drawings.

Images