Expandable frame for medical devices

Abstract

An artificial heart valve for treating structural heart disease, comprising an expandable frame formed of a rhenium-containing metal alloy. Novel geometric shapes of the expandable frame combined with a frame partially or completely formed of a rhenium-containing alloy allow for the formation of a frame that a) has an open-cell geometric shape of the frame of the artificial heart valve, which can be used to reduce the size of the delivery system; b) has high radial strength; c) improves the recovery of physiological EGA; d) has less rebound; e) has no shortening; f) allows for proper placement of the bioprosthetic valve relative to the innate commissure of the valve; h) results in a low incidence of Leaflet thrombosis and structural valve deterioration; and i) prevents allergic reactions and restenosis associated with nickel content.

Description

TECHNICAL FIELD

[0001] (Related Applications) This application claims priority to U.S. Provisional Application No. 63 / 540,556 filed on September 26, 2023, which is incorporated herein by reference.

[0002] (Field of the Disclosure) The present disclosure relates generally to medical devices and medical device applications, specifically to medical devices comprising an expandable frame, more specifically to medical devices in the form of cardiovascular implants for treating structural heart disease, wherein the cardiovascular implant comprises an expandable frame, and even more specifically to medical devices in the form of prosthetic heart valves for treating structural heart disease, wherein the prosthetic heart valve comprises an expandable frame. BACKGROUND ART

[0003] Many cardiovascular devices, such as expandable heart valves, are inserted into a patient via the patient's vasculature and then expanded at a treatment site. These devices are typically crimped onto a catheter prior to insertion into the patient.

[0004] Medical devices such as transcatheter aortic valves (TAVs) represent a significant advance in artificial heart valve technology. TAVs bring the benefits of heart valve replacement to patients who would otherwise not undergo surgery. Transcatheter aortic valve replacement (TAVR) can be used to treat aortic stenosis in patients classified as high-risk for open-heart surgical aortic valve replacement (SAVR). Non-limiting TAVs are disclosed in U.S. Patents 5,411,522, 6,730,118, 10,729,543, 10,820,993, 10,856,970, 10,869,761, 10,952,852, 10,980,632, 10,980,633, and U.S. Patent Application Publication 2020 / 0405482, all of which are fully incorporated herein by reference. The frame materials used to form TAVs are typically TiAlV alloys, CoCr alloys, or Nitinol™. Most cardiovascular implants include valves that are at least partially fabricated by using CoCr alloy or Nitinol to construct the valve's structural frame.

[0005] A transcatheter aortic valve (TAV) is compressed within a small-diameter catheter and remotely positioned within the patient's affected aortic valve, designed to take over the function of the natural valve. Some TAVs are balloon-inflatable, while others are self-inflatable. In both cases, the TAV is deployed within the calcified natural valve, which is forcibly and permanently opened, becoming a surface where friction holds the frame in place. TAVs can also be used to replace faulty bioprosthetic or transcatheter valves, commonly known as a valve-in-valve procedure. The main advantages of TAVR over conventional surgical approaches include a significant reduction in patient morbidity by avoiding cardiopulmonary bypass, aortic cross-clamping, and sternotomy.

[0006] However, current TAV devices are associated with multiple complications, including severe vascular damage or bleeding due to large delivery profiles, mispositioning, compression-induced leaflet damage, paravalvular leakage, thrombosis, conduction abnormalities, and prosthesis-patient mismatch.

[0007] TAVR involves the delivery, deployment, and implantation of a valve with a compressed frame into an affected or degenerated aortic valve. Some limitations of the current TAVR procedure include: a) vascular complications such as dissection or severe bleeding due to the large size of the delivery system; b) rebound associated with the valve frame, defined as the valve frame opening to a certain diameter and then relaxing or settling to a smaller diameter after balloon deflation, which can lead to valve embolism, paravalvular leakage, and a reduction in effective orifice area (EOA); and c) a high incidence of conduction system damage, which can lead to permanent pacemaker implantation or sudden cardiac death, as conduction abnormalities are exacerbated by the frame rebound, so the operator must be careful after balloon deflation. These include: d) the need to reach a larger balloon inflation diameter to obtain a physiologically effective orifice area; e) shortening of the frame during balloon expansion, which can lead to mispositioning of the valve in the aortic annulus; f) improper alignment of the TAVR frame commissure with the innate commissure, which negatively impacts hemodynamic performance and the durability of the prosthetic valve; f) uneven expansion of the valve frame, which can lead to a non-cylindrical prosthetic valve, resulting in an increased risk of acute and chronic complications such as Leaflet's thrombosis and structural valve deterioration; and g) high nickel content, which is a common allergen.

[0008] Current structural heart valve procedures are limited by the combination of materials and geometric shapes of the artificial heart valve frame. Disadvantages include: a) vascular complications such as dissection or severe bleeding due to the large size of the delivery system; b) neurological complications such as stroke due to the large size of the delivery system passing through calcified anatomical structures; c) insufficient radial strength to restore physiological EOA in the affected valve while maintaining the compression diameter for vascular access; d) rebound associated with the valve frame, defined as the valve frame opening to a certain diameter and then relaxing or settling to a smaller diameter after balloon deflation, which can lead to valve embolism, paravalvular leakage, and a decrease in effective orifice area (EOA); e) a high incidence of conduction system damage, which can lead to permanent pacemaker implantation or sudden cardiac death; conduction abnormalities are exacerbated by the rebound of the frame, so the operator needs to reach a larger balloon inflation diameter to obtain a physiologically effective orifice area after balloon deflation; and f) in the aortic annulus. g) shortening of the frame during balloon expansion of the frame, which can lead to mispositioning of the valve; h) improper alignment of the commissures of the prosthetic heart valve frame with the innate commissures, which adversely affects hemodynamic performance, coronary blood flow, and durability of the prosthetic valve; i) impaired coronary artery access for acute coronary artery injury and re-intervention due to misalignment of frame height, commissure misalignment, and open cell geometry at the location of the coronary arteries; j) uneven valve frame expansion, which can lead to a non-cylindrical prosthetic valve, which leads to an increased risk of acute and chronic complications such as Leaflet's thrombosis and structural valve deterioration; and k) high nickel content, which is a common allergen.

[0009] From the perspective of current artificial heart valve technology, there is a need for improved artificial heart valves that address the aforementioned shortcomings. [Overview of the project] [Means for solving the problem]

[0010] This disclosure relates to medical devices and applications for medical devices, and more specifically to medical devices including expandable frames, more specifically to medical devices in the form of cardiovascular implants for treating structural heart disease, wherein the cardiovascular implant includes an expandable frame, and even more specifically to medical devices in the form of artificial heart valves for treating structural heart disease, wherein the artificial heart valve includes an expandable frame formed of a rhenium-containing metal alloy. The use of rhenium-containing metal alloys to partially or completely form the frame of an artificial heart valve enables novel geometric shapes for structural artificial heart valve frames. The combination of rhenium-containing metal alloys and novel geometric shapes for artificial heart valve frames addresses the current shortcomings of artificial heart valves discussed above. Novel geometric shapes for artificial heart valve frames, combined with frames partially (e.g., 10–99.99 wt% and all values ​​and ranges in between) or completely formed of rhenium-containing alloys, enable the formation of frames such as: a) Has an open-cell geometric shape that can be used to reduce the size of the delivery system, thereby reducing vascular and neurological complications; b) Has an open-cell pattern with high radial strength due to the high yield strength and maximum tensile strength of the rhenium-containing metal alloy; c) Has improved recovery of physiological EOA in severely calcified valves that are difficult to force large on the bioprosthetic valve, while also allowing a reduced compression diameter for vascular access; d) Has improved recovery of physiological EOA, resulting in a longer service life of the bioprosthetic valve; e) Has lower rebound than conventional materials used to form the frame, such as stainless steel, chromium-cobalt alloy, or titanium alloy, thereby resulting in less rebound of the frame when expanded, which leads to a reduced risk of valve embolism, reduced paravalvular leakage due to improved fit to the innate anatomical structure, more accurate recovery of physiological EOA, and reduced conduction system damage due to a smaller balloon expansion diameter required to obtain physiological EOA after balloon inflation; f) When expanded, has little shortening (e.g., 0-20% shortening)g) It has an open-cell geometric shape configured to have (all values ​​and ranges) or none at all, thereby enabling more precise placement of the valve in the innate annulus, and the frame, which has little or no shortening when expanded, can be expanded with a shorter balloon, and conduction system damage can be reduced by using a shorter balloon for frame expansion, g) It has commissure alignment markers and open cells between commissures, which enables proper placement of the bioprosthetic valve relative to the innate commissures of the valve for proper hemodynamic function with respect to washout from the valve and blood flow to the coronary arteries, and this leads to higher durability and longer service life of the valve, as well as coronary artery access and re-intervention that prevents future adverse events, h) It has an open-cell geometric shape that is radially symmetric, longitudinally symmetric, and has little or no shortening, thereby enabling symmetrical and cylindrical expansion of the prosthetic valve, resulting in a reduction in the incidence of Leaflet thrombosis and structural valve deterioration, and i) It is formed of a rhenium-containing metal alloy that does not contain nickel, preventing allergic reactions due to the presence of nickel and restenosis associated with nickel content.

[0011] In one non-limiting embodiment of the present disclosure, an artificial heart valve (e.g., a heart valve, TAVR valve, mitral valve replacement, tricuspid valve replacement, pulmonary valve replacement, etc.) includes a radially foldable and expandable frame and a leaflet structure comprising a plurality of leaflets. In another non-limiting embodiment, the artificial heart valve optionally includes an annular skirt or cover member disposed on at least a portion of the cells of the frame, partially or completely covering the cells, or overlapping the cells. In another non-limiting embodiment, the frame of the artificial heart valve comprises a plurality of interconnected axial longitudinal members, angular joint members, and strut joints defining a plurality of open cells within the frame.

[0012] In other and / or alternative non-limiting aspects of this disclosure, the frame of an artificial heart valve is optionally a) a heat-resistant metal alloy and / or b) a metal alloy containing at least 15 atomic percentages (awt.%) or atomic percentages (awt%) of rhenium to produce a “rhenium effect” in the metal alloy. Where used herein, atomic percentages (awt.%) and atomic percentages (awt%) are used interchangeably. As defined herein, weight percentage (wt%) of an element is obtained by dividing the weight of that element measured in the sample by the weight of all elements in the sample and multiplying by 100. Atomic percentage or atomic percentage (awt%) is obtained by dividing the number of atoms of that element in its weight percentage by the total number of atoms in the sample and multiplying by 100. The use of the terms weight percentage (wt%) and atomic percentage or atomic percentage (awt.%) is two ways of referring to a metal alloy and its components. For several metal alloys, it has been found that the inclusion of at least 15 awt.% rhenium improves the ductility and / or tensile strength of the metal alloy compared to metal alloys that do not contain rhenium. Such improvement in ductility and / or tensile strength due to the inclusion of at least 15 awt.% rhenium in a metal alloy is referred to as the “rhenium effect.” As defined herein, the “rhenium effect” is a) an increase of at least 10% in ductility of a metal alloy caused by the addition of rhenium to the metal alloy, and / or b) an increase of at least 10% in tensile strength of a metal alloy caused by the addition of rhenium to the metal alloy. As defined herein, a heat-resistant metal alloy is a metal alloy containing at least 20 wt% of one or more of molybdenum, rhenium, niobium, tantalum, or tungsten. Examples of non-limiting heat-resistant metal alloys include MoRe alloys, ReW alloys, MoReCr alloys, MoReTa alloys, MoReTi alloys, WCu alloys, ReCr, molybdenum alloys, rhenium alloys, tungsten alloys, tantalum alloys, and niobium alloys. In one non-limiting configuration, 50–100% by weight (and all values ​​and ranges in between) of the expandable frame of the artificial heart valve is formed of a heat-resistant metal alloy, or a metal alloy containing at least 15 awt.% rhenium.In another non-limiting configuration, the metal alloy used to partially or completely form the expandable frame of the artificial heart valve contains at least 30 wt% (e.g., 30–99 wt%, and all values ​​and ranges in between) one or more of molybdenum, rhenium, niobium, tantalum, or tungsten. In another non-limiting embodiment, a heat-resistant metal alloy, or a metal alloy containing at least 15 awt.% rhenium, may be used for the following purposes:1) Increase the radiopaqueness of the artificial heart valve frame, 2) Increase the radial strength of the artificial heart valve frame, 3) Increase the yield strength and / or maximum tensile strength of the artificial heart valve frame, 4) Improve the stress-strain properties of the artificial heart valve frame, 5) Improve the crimping and / or expansion properties of the artificial heart valve frame, 6) Improve the bendability and / or flexibility of the artificial heart valve frame, 7) Improve the strength and / or durability of the artificial heart valve frame, 8) Increase the hardness of the artificial heart valve frame, 9) Improve the biosafety and / or biocompatibility properties of the artificial heart valve frame, 10) Increase the fatigue resistance of the artificial heart valve frame, 11) Resist the cracking of the artificial heart valve frame, 12) Resist the propagation of cracks in the artificial heart valve frame, 13) Enable the fabrication of smaller, thinner, and / or lighter artificial heart valve frames, 14) Crimped 15) To facilitate the reduction of the outer diameter of the artificial heart valve, 16) To improve the fit of the artificial heart valve frame to the shape of the treatment area when the artificial heart valve is expanded in the treatment area, 17) To reduce the rebound of the artificial heart valve frame after the frame has been expanded in the treatment area, 18) To reduce harmful tissue reactions with the artificial heart valve frame, 19) To reduce the release of metal ions from the frame after implantation of the artificial heart valve, 20) To reduce allergic reactions with the artificial heart valve frame after implantation (e.g., by reducing the nickel content of the metal alloy), 21) To improve the hydrophilicity of the artificial heart valve frame, 22) To reduce the magnetic susceptibility of the artificial heart valve frame, 23) To reduce the shortening of the artificial heart valve frame when the artificial heart valve frame is expanded, and / or 24) To reduce the toxicity of the artificial heart valve frame after implantation.

[0013] In other and / or alternative non-limiting embodiments of the present disclosure, the frame of an artificial heart valve may be partially or completely formed of standard stainless steel, standard CoCr alloy, standard TiAlV alloy, standard aluminum alloy, standard nickel alloy, standard titanium alloy, standard tungsten alloy, standard molybdenum alloy, standard copper alloy, standard MP35N alloy, or standard beryllium-copper alloy, which may be optionally modified to contain at least 15 awt.% rhenium to provide improved ductility and / or tensile strength compared to the same metal alloy that does not contain rhenium. As defined herein, standard stainless steel alloys (SS alloys) contain 10–28 wt% (weight percent) of chromium, 0–35 wt% of nickel, 0–4 wt% of molybdenum, 0–2 wt% of manganese, 0–0.75 wt% of silicon, 0–0.3 wt% of carbon, 0–5 wt% of titanium, 0–10 wt% of niobium, 0–5 wt% of copper, 0–4 wt% of aluminum, 0–10 wt% of tantalum, 0–1 wt% of se, 0–2 wt% of vanadium, 0–2 wt% of tungsten, and at least 50 wt% of iron. Standard 316L alloys, included in standard stainless steel alloys, contain 17–19 wt% of chromium, 13–15 wt% of nickel, 2–4 wt% of molybdenum, up to 2 wt% of manganese, up to 0.75 wt% of silicon, up to 0.03 wt% of carbon, and the remainder being iron. As defined herein, a standard cobalt-chromium alloy (CoCr alloy) contains 15–32 wt% chromium, 1–38 wt% nickel, 2–18 wt% molybdenum, 0–18 wt% iron, 0–1 wt% titanium, 0–0.15 wt% manganese, 0–0.15 wt% silver, 0–0.25 wt% carbon, 0–16 wt% tungsten, 0–2 wt% silicon, 0–2 wt% aluminum, 0–1 wt% iron, 30–68 wt% cobalt, 0–0.1 wt% boron, 0–0.15 wt% silver, and 0–2 wt% titanium. Standard MP35N alloys, which are included in standard CoCr alloys, contain 18–22 wt% chromium, 32–38 wt% nickel, 8–12 wt% molybdenum, 0–2 wt% iron, 0–0.5 wt% silicon, 0–0.5 wt% manganese, 0–0.2 wt% carbon, 0–2 wt% titanium, 0–0.1 wt% boron, 0–0.15 wt% silver, and the remainder cobalt.As defined herein, standard Phynox and standard Elgiloy alloys, which are included in standard CoCr alloys, contain 38–42 wt% cobalt, 18–22 wt% chromium, 14–18 wt% iron, 13–17 wt% nickel, and 6–8 wt% molybdenum. As defined herein, standard L605 alloy, which is included in standard CoCr alloys, contains 18–22 wt% chromium, 14–16 wt% tungsten, 9–11 wt% nickel, and the remainder cobalt. As defined herein, standard titanium-aluminum-vanadium alloy (TiAlV alloy) contains 5.5–6.75 wt% aluminum, 3.5–4.5 wt% vanadium, 85–93 wt% titanium, 0–0.4 wt% iron, and 0–0.2 wt% carbon. Standard Ti-6Al-4V alloys, which are included in standard TiAlV alloys, contain 3.5–4.5 wt% vanadium, 5.5–6.75 wt% aluminum, up to 0.3 wt% iron, up to 0.08 wt% carbon, up to 0.05 wt% yttrium, and the remainder titanium. As defined herein, standard aluminum alloys contain 80–99 wt% aluminum, 0–12 wt% silicon, 0–5 wt% magnesium, 0–1 wt% manganese, 0–0.5 wt% scandium, 0–0.5 wt% beryllium, 0–0.5 wt% yttrium, 0–0.5 wt% cerium, 0–0.5 wt% chromium, 0–3 wt% iron, 0–0.5, 0 It contains approximately 9 wt% zinc, 0-0.5 wt% titanium, 0-3 wt% lithium, 0-0.5 wt% silver, 0-0.5 wt% calcium, 0-0.5 wt% zirconium, 0-1 wt% lead, 0-0.5 wt% cadmium, 0-0.05 wt% bismuth, 0-1 wt% nickel, 0-0.2 wt% vanadium, 0-0.1 wt% gallium, and 0-7 wt% copper. As defined herein, a standard nickel alloy contains 30–98 wt% nickel, 5–25 wt% chromium, 0–65 wt% iron, 0–30 wt% molybdenum, 0–32 wt% copper, 0–32 wt% cobalt, 2–2 wt% aluminum, 0–6 wt% tantalum, 0–15 wt% tungsten, 0–5 wt% titanium, 0–6 wt% niobium, and 0–3 wt% silicon.As defined herein, a standard titanium alloy contains 80–99 wt% titanium, 0–6 wt% aluminum, 0–3 wt% tin, 0–1 wt% palladium, 0–8 wt% vanadium, 0–15 wt% molybdenum, 0–1 wt% nickel, 0–0.3 wt% ruthenium, 0–6 wt% chromium, 0–4 wt% zirconium, 0–4 wt% niobium, 0–1 wt% silicon, 0.0.5 wt% cobalt, and 0–2 wt% iron. As defined herein, a standard tungsten alloy contains 85–98 wt% tungsten, 0–8 wt% nickel, 0–5 wt% copper, 0–5 wt% molybdenum, and 0–4 wt% iron. As defined herein, a standard molybdenum alloy contains 90–99.5 wt% molybdenum, 0–1 wt% nickel, 0–1 wt% titanium, 0–1 wt% zirconium, 0–30 wt% tungsten, 0–2 wt% hafnium, and 0–2 wt% lanthanum. As defined herein, a standard copper alloy contains 55–95 wt% copper, 0–40 wt% zinc, 0–10 wt% tin, 0–10 wt% lead, 0–1 wt% iron, 0–5 wt% silicon, 0–12 wt% manganese, 0–12 wt% aluminum, 0–3 wt% beryllium, 0–1 wt% cobalt, and 0–20 wt% nickel. As defined herein, a standard beryllium-copper alloy contains 95–98.5 wt% copper, 1–4 wt% beryllium, 0–1 wt% cobalt, and 0–0.5 wt% silicon. As defined herein, a standard titanium-nickel alloy (e.g., Nitinol alloy) contains 42–58 wt% nickel and 42–58 wt% titanium. The rhenium effect has been found to occur when the atomic weight of rhenium in a metallic alloy is at least 15% (e.g., 15–99 wt.% rhenium in a metallic alloy, and all values ​​and ranges in between). For example, in the case of a standard stainless steel alloy, the rhenium effect may begin to be present when the stainless steel alloy is modified to contain at least 5–10 wt% rhenium (and all values ​​and ranges in between) in the stainless steel alloy.In the case of a standard CoCr alloy, the rhenium effect may begin to appear when the CoCr alloy is modified to contain at least 4.8–9.5 wt% rhenium (and all values ​​and ranges in between) of the CoCr alloy. In the case of a standard TiAlV alloy, the rhenium effect may begin to appear when the TiAlV alloy is modified to contain at least 4.5–9 wt% rhenium (and all values ​​and ranges in between) of the TiAlV alloy. It can be understood that the rhenium content in the above non-limiting examples may be greater than the minimum amount required to produce the rhenium effect in a metallic alloy.

[0014] According to another and / or alternative aspect of this disclosure, the metal alloy used to partially or completely form the frame of the artificial heart valve is at least 5 awt.% (e.g., 5 to 99 awt.% (and all values ​​and ranges in between)) of rhenium and aluminum, boron, beryllium, bismuth, cadmium, calcium, cerium, chromium, cobalt, copper, gallium, gold, hafnium, iridium, iron, lanthanum, lanthanum oxide, lead, lithium, magnesium, manganese, molybdenum, nickel, niobium, osmium, paraben The metal alloy comprises one or more additives in 0.1 to 96 wt% (and all values ​​and ranges in between) selected from the group consisting of um, platinum, rare earth metals, rhodium, ruthenium, scandium, silver, silicon, tantalum, technetium, tin, titanium, tungsten, vanadium, yttrium, zinc, and / or zirconium, and optionally comprises 0 to 2 wt% (and all values ​​and ranges in between) of other metals (e.g., metals other than additives), carbon, oxygen, phosphorus, sulfur, hydrogen, and / or nitrogen, and the metal alloy comprises, The rhenium effect is observed. In one non-limiting embodiment, the metal alloy used to partially or completely form the frame of the artificial heart valve is a standard stainless steel alloy modified to contain at least 15 awt.% rhenium. In another non-limiting embodiment, the metal alloy used to partially or completely form the frame of the artificial heart valve is a standard cobalt-chromium alloy modified to contain at least 15 awt.% rhenium. In yet another non-limiting embodiment, the metal alloy used to partially or completely form the frame of the artificial heart valve is a standard TiAlV alloy modified to contain at least 15 awt.% rhenium. In yet another non-limiting embodiment, the metal alloy used to partially or completely form the frame of the artificial heart valve is a standard aluminum alloy modified to contain at least 15 awt.% rhenium. In yet another non-limiting embodiment, the metal alloy used to partially or completely form the frame of the artificial heart valve is a standard nickel alloy modified to contain at least 15 awt.% rhenium.In another non-limiting embodiment, the metal alloy used to partially or completely form the frame of the artificial heart valve is a standard titanium alloy modified to contain at least 15 awt.% rhenium. In another non-limiting embodiment, the metal alloy used to partially or completely form the frame of the artificial heart valve is a standard tungsten alloy modified to contain at least 15 awt.% rhenium. In another non-limiting embodiment, the metal alloy used to partially or completely form the frame of the artificial heart valve is a standard molybdenum alloy modified to contain at least 15 awt.% rhenium. In another non-limiting embodiment, the metal alloy used to partially or completely form the frame of the artificial heart valve is a standard copper alloy modified to contain at least 15 awt.% rhenium. In another non-limiting embodiment, the metal alloy used to partially or completely form the frame of the artificial heart valve is a standard beryllium copper alloy modified to contain at least 15 awt.% rhenium.

[0015] According to another and / or alternative aspect of this disclosure, the metal alloy used to partially or completely form the frame of an artificial heart valve comprises rhenium and molybdenum, wherein the weight percentage of rhenium in the metal alloy is optionally greater than the weight percentage of molybdenum in the metal alloy, and the metal alloy contains one or more additives (e.g., aluminum, boron, beryllium, bismuth, cadmium, calcium, cerium, chromium, cobalt, copper, gallium, gold, hafnium, iridium, iron, lanthanum, lanthanum oxide, lead, lithium) The weight percentage of magnesium, manganese, molybdenum, nickel, niobium, osmium, palladium, platinum, rare earth metals, rhodium, ruthenium, scandium, silver, silicon, tantalum, technetium, tin, titanium, tungsten, vanadium, yttrium, zinc, and / or zirconium) is optionally greater than the weight percentage of molybdenum in the metal alloy, and the metal alloy optionally includes 0-2 wt% of other metals (metals other than additives), carbon, oxygen, phosphorus, sulfur, hydrogen, and / or nitrogen. In one non-limiting embodiment, the metal alloy used to partially or completely form the frame of an artificial heart valve includes rhenium and molybdenum, where the weight percentage of rhenium + the total weight percentage of additives is greater than the weight percentage of molybdenum, and the metal alloy optionally includes 0-2 wt% of other metals (metals other than additives), carbon, oxygen, phosphorus, sulfur, hydrogen, and / or nitrogen.

[0016] According to another and / or alternative aspect of the present disclosure, the metal alloy used to partially or completely form the frame of an artificial heart valve comprises rhenium and molybdenum, wherein the ratio of the atomic percentage of rhenium to the atomic percentage of one or more combinations of bismuth, niobium, tantalum, tungsten, titanium, vanadium, chromium, manganese, yttrium, zirconium, technetium, ruthenium, rhodium, hafnium, osmium, copper, and iridium is 0.4:1 to 2.5:1 (as well as all values ​​and ranges in between).

[0017] According to another and / or alternative aspect of the present disclosure, the metal alloy used to partially or completely form the frame of an artificial heart valve comprises at least 5 wt.% (e.g., 5 to 99 wt.% and all values ​​and ranges in between) of rhenium and at least two elements selected from the group consisting of molybdenum, bismuth, chromium, iridium, niobium, tantalum, titanium, yttrium, and zirconium, with a content of 0 to 0.1 wt% of other elements and compounds in the metal alloy. In another non-limiting embodiment, the metal alloy comprises rhenium, molybdenum, and chromium. In another non-limiting embodiment, the metal alloy comprises at least 35 wt% (e.g., 35 to 75 wt% and all values ​​and ranges in between) of rhenium, and the metal alloy also comprises chromium. In one non-limiting embodiment, the metal alloy contains at least 35 wt% rhenium, at least 25 wt% (e.g., 25 to 49.9 wt% and all values ​​and ranges in between) of the metal alloy contains chromium, and optionally, 0.1 to 40 wt% (and all values ​​and ranges in between) of the metal alloy contains aluminum, boron, beryllium, bismuth, cadmium, calcium, cerium, chromium, cobalt, copper, gallium, gold, hafnium, iridium, iron, lanthanum, lanthanum oxide, and lead. The metal alloy comprises one or more of lithium, magnesium, manganese, molybdenum, nickel, niobium, osmium, palladium, platinum, rare earth metals, rhodium, ruthenium, scandium, silver, silicon, tantalum, technetium, tin, titanium, tungsten, vanadium, yttrium, zinc, and / or zirconium, and optionally comprises 0–2 wt% (and all values ​​and ranges between them) of other metals, carbon, oxygen, phosphorus, sulfur, hydrogen, and / or nitrogen. In another non-limiting embodiment, the metal alloy comprises 15–50 awt.% (and all values ​​and ranges between them) of rhenium and 0.5–70 awt.% (and all values ​​and ranges between them) of chromium. In another non-limiting embodiment, the metal alloy comprises 15–50 awt.% (and all values ​​and ranges between them) of rhenium and 0.5–70 awt.% (and all values ​​and ranges between them) of tantalum.In another non-limiting embodiment, the metal alloy comprises 15–50 awt.% (and all values ​​and ranges in between) of rhenium and 0.5–70 awt.% (and all values ​​and ranges in between) of niobium. In another non-limiting embodiment, the metal alloy comprises 15–50 awt.% (and all values ​​and ranges in between) of rhenium and 0.5–70 awt.% (and all values ​​and ranges in between) of titanium. In another non-limiting embodiment, the metal alloy comprises 15–50 awt.% (and all values ​​and ranges in between) of rhenium and 0.5–70 awt.% (and all values ​​and ranges in between) of zirconium. In another non-limiting embodiment, the metal alloy comprises 15–50 awt.% (and all values ​​and ranges in between) of rhenium and 0.5–70 awt.% (and all values ​​and ranges in between) of molybdenum. In another non-limiting embodiment, the metal alloy comprises at least 15 wt.% rhenium, more than 50 wt% titanium (e.g., 51–80 wt%, and all values ​​and ranges in between), 15–45 wt% (and all values ​​and ranges in between) niobium, 0–10 wt% (and all values ​​and ranges in between) zirconium, 0–15 wt% (and all values ​​and ranges in between) tantalum, and 0–8 wt% (and all values ​​and ranges in between) molybdenum.

[0018] Several non-limiting examples of metal alloys that can be used to partially or completely form orthopedic medical devices are listed below in weight percentages. Ingredients / Weight % Example 1 Example 2 Example 3 Example 4 Al 0-35% 0-30% 0-25% 0-10% Bi 0~20% 0~20% 0~20% 0~20% Cr 0-60% 0-35% 0-30% 0-25% Co 0-60% 0-50% 0-40% 0-20% Mo 0-95% 0-80% 0-55% 0-30% Nb 0~80% 0~60% 0~50% 0~20% Ni 0~60% 0~55% 0~40% 0~20% Re 0.1~70% 4.5~70% 5~70% 5~70% Ta 0~80% 0~50% 0~40% 0~25% Ti 0~60% 0~55% 0~40% 0~20% V 0~20% 0~15% 0~10% 0~10% W 0~80% 0~70% 0~50% 0~20% Y 0~20% 0~15% 0~10% 0~10% Zr 0~20% 0~15% 0~10% 0~10% Component / wt% Example 5 Example 6 Example 7 Example 8 Ag 0~20% 0~20% 0~20% 0~20% Al 0~35% 0~30% 5~30% 0~25% Bi 0~20% 0~20% 0~20% 0~20% Cr 10~40% 0~40% 0~40% 0~40% Cu 0~20% 0~20% 0~20% 0~20% Co 10~60% 0~60% 0~60% 0~60% Fe 0~80% 30~80% 0~80% 0~70% Hf 0~20% 0~20% 0~20% 0~20% Ir 0~20% 0~20% 0~20% 0~20% Mg 0~20% 0~20% 0~20% 0~20% Mn 0~20% 0~40% 0~20% 0~20% Mo 0~60% 0~60% 0~80% 0~70% Nb 0~60% 0~60% 0~65% 20~60% Ni 0~60% 5~55% 0~52% 0~50% Os 0~20% 0~20% 0~20% 0~20% Pt 0~20% 0~20% 0~20% 0~20% Re 4.5~98% 4.5~90% 4.5~80% 4.5~70% Rh 0-20% 0-20% 0-20% 0-20% Si 0~20% 0~20% 0~20% 0~20% Sn 0~20% 0~20% 0~20% 0~20% Ta 0~60% 0~60% 5~65% 0~60% Tc 0~20% 0~20% 0~20% 0~20% Ti 0-60% 0-55% 0-53% 0-50% V 0~20% 0~20% 2~20% 0~20% W 0~60% 0~60% 0~80% 0~70% Y 0~20% 0~20% 0~20% 0~20% Zr 0~20% 0~20% 0~20% 5~20% Ingredients / Weight % Example 9 Example 10 Example 11 Example 12 Ag 0~5% 0~5% 0~5% 0~5% Al 0-5% 0-5% 1-15% 0-20% Bi 0~5% 0~5% 0~5% 0~5% Cr 1-28% 1-30% 0-5% 0-30% Cu 0-20% 0-5% 0-5% 0-25% Co 0-5% 1-60% 0-5% 0-60% Fe 10-80% 0-25% 0-5% 0-80% Hf 0~5% 0~5% 0~5% 0~5% Ir 0~5% 0~5% 0~5% 0~5% Mg 0-5% 0-5% 0-5% 0-5% Mn 0~5% 0~5% 0~5% 0~5% Mo 0-8% 0-25% 0-5% 0-98% Nb 0-5% 0-5% 0-5% 0-95% Ni 1-20% 1-45% 0-5% 0-50% Os 0~5% 0~5% 0~5% 0~5% Pt 0~5% 0~5% 0~5% 0~5% Re 5~20% 4.8~20% 4.5~20% 4.5~20% Rh 0-5% 0-5% 0-5% 0-5% Si 0~5% 0~5% 0~5% 0~5% Sn 0~5% 0~5% 0~5% 0~5% Ta 0~5% 0~5% 0~5% 0~98% Tc 0~5% 0~5% 0~5% 0~5% Ti 0-5% 0-5% 40-93% 0-93% V 0~5% 0~5% 1~10% 0~20% W 0~5% 0~20% 0~5% 0~98% Y 0~5% 0~5% 0~5% 0~5% Zr 0~5% 0~5% 0~5% 0~5% Ingredients / Weight % Example 13 Example 14 Example 15 Example 16 Mo 30~80% 35~80% 30~70% 35~65% Hf 0.8~1.4% 0~2% 0~2.5% 0~2.5% Re 7~49% 7~49% 7~60% 7.5~49% Ta 0~2% 0~2% 0~50% 0~50% W 0~2% 0~2% 0~50% 20~50% Ingredients / Weight % Example 17 Example 18 Example 10 Example 20 W 20-93% 60-92% 20-75% 5-98% Re 6~60% 8~40% 7.5~47.5% 0~80% Mo 0~47.5% <0.5% 1~47.5% 0~80% Ingredients / Weight % Example 21 Example 22 Example 23 Example 24 Re 5~60% 5~60% 5~60% 5~60% Mo 0~55% 10~55% 10~55% 10~55% Bi 1~42 0~32 0~32 0~32 Cr 0~32 1~42 0~32 0~32 Ir 0~32 0~32 1~42 0~32 Nb 0~32 0~32 0~32 1~42 Ta 0~32 0~32 0~32 0~32 Ti 0~32 0~32 0~32 0~32 Y 0~32 0~32 0~32 0~32 Zr 0~32 0~32 0~32 0~32 Ingredients / Weight % Example 25 Example 26 Example 27 Example 28 Re 5~60% 5~60% 5~60% 5~60% Mo 15~55% 15~55% 15~55% 15~55% Bi 0~32 0~32 0~32 0~32 Cr 0~32 0~32 0~32 0~32 Ir 0~32 0~32 0~32 0~32 Nb 0~32 0~32 0~32 0~32 Ta 1~42 0~32 0~32 0~32 Ti 0~32 1~42 0~32 0~32 Y 0~32 0~32 1~42 0~32 Zr 0~32 0~32 0~32 1~42 Ingredients / Weight % Example 29 Example 30 Example 31 Example 32 Re 50~75% 55~75% 60~75% 65~75% Cr 25~50% 25~45% 25~40% 25~35% Mo 0~25% 0~25% 0~25% 0~25% Bi 0~25% 0~25% 0~25% 0~25% Ir 0~25% 0~25% 0~25% 0~25% Nb 0~25% 0~25% 0~25% 0~25% Yes 0~25% 0~25% 0~25% 0~25% V 0~25% 0~25% 0~25% 0~25% W 0~25% 0~25% 0~25% 0~25% Mn 0~25% 0~25% 0~25% 0~25% Tc 0~25% 0~25% 0~25% 0~25% About 0~25% 0~25% 0~25% 0~25% RH 0~25% 0~25% 0~25% 0~25% Hf 0~25% 0~25% 0~25% 0~25% If 0~25% 0~25% 0~25% 0~25% With 0~25% 0~25% 0~25% 0~25% Ir 0~25% 0~25% 0~25% 0~25% Ti 0~25% 0~25% 0~25% 0~25% Y 0~25% 0~25% 0~25% 0~25% Zr 0~25% 0~25% 0~25% 0~25% At 0~25% 0~25% 0~25% 0~25% Al 0~25% 0~25% 0~25% 0~22% Co 0~25% 0~25% 0~25% 0~25% Fe 0~25% 0~25% 0~25% 0~25% Mg 0~25% 0~25% 0~25% 0~25% Nothing 0~25% 0~25% 0~25% 0~25% Pt 0~25% 0~25% 0~25% 0~25% Yes 0~25% 0~25% 0~25% 0~25% Sn 0~25% 0~25% 0~25% 0~25% Ingredients / Weight % Example 33 Example 34 Example 35 Example 36 Re 50~75% 55~72% 60~70% 62~70% Cr 24~49% 27~44% 29~39% 29~37% Mo 1-15% 1-10% 1-8% 1-5% Bi 0-15% 0-10% 0-8% 0-5% Ir 0-15% 0-10% 0-8% 0-5% Nb 0-15% 0-10% 0-8% 0-5% Ta 0-15% 0-10% 0-8% 0-5% V 0-15% 0-10% 0-8% 0-5% W 0-15% 0-10% 0-8% 0-5% Mn 0-15% 0-10% 0-8% 0-5% Tc 0-15% 0-10% 0-8% 0-5% Ru 0-15% 0-10% 0-8% 0-5% Rh 0-15% 0-10% 0-8% 0-5% Hf 0-15% 0-10% 0-8% 0-5% Os 0-15% 0-10% 0-8% 0-5% Cu 0-15% 0-10% 0-8% 0-5% Ir 0-15% 0-10% 0-8% 0-5% Ti 0-15% 0-10% 0-8% 0-5% Y 0-15% 0-10% 0-8% 0-5% Zr 0-15% 0-10% 0-8% 0-5% Ag 0-15% 0-10% 0-8% 0-5% Al 0-15% 0-10% 0-8% 0-5% Co 0-15% 0-10% 0-8% 0-5% Fe 0-15% 0-10% 0-8% 0-5% Mg 0-15% 0-10% 0-8% 0-5% Ni 0-15% 0-10% 0-8% 0-5% Pt 0-15% 0-10% 0-8% 0-5% Si 0-15% 0-10% 0-8% 0-5% Sn 0-15% 0-10% 0-8% 0-5% Ingredients / Weight % Example 37 Example 38 Example 39 Example 40 Mo 40~95% 40~95% 40~95% 40~95% Co ≦0.002% ≦0.002% ≦0.002% ≦0.002% Fe ≦0.02% ≦0.02% ≦0.02% ≦0.02% Hf 0.1~2.5% 0~2.5% 0~2.5% 0~2.5% Os ≤ 1% ≤ 1% ≤ 1% ≤ 1% Nb ≦0.01% ≦0.01% ≦0.01% ≦0.01% Pt ≤ 1% ≤ 1% ≤ 1% ≤ 1% Re 5~49% 5~49% 5~49% 5~49% Sn ≦0.002% ≦0.002% ≦0.002% ≦0.002% Ta 0~50% 0~50% 0~50% 0~50% Tc ≤ 1% ≤ 1% ≤ 1% ≤ 1% Ti ≤ 1% ≤ 1% ≤ 1% ≤ 1% V ≤ 1% ≤ 1% ≤ 1% ≤ 1% W 0~50% 0~50% 0~50% 0.5~50% Zr ≤ 1% ≤ 1% ≤ 1% ≤ 1% Ag 0~5% 0~5% 0~5% 0~5% Al 0~5% 0~5% 0~5% 0~5% Co 0~5% 0~5% 0~5% 0~5% Mg 0-5% 0-5% 0-5% 0-5% Ni 0~5% 0~5% 0~5% 0~5% Si 0~5% 0~5% 0~5% 0~5% Sn 0~5% 0~5% 0~5% 0~5% Ingredients / Weight % Example 41 Example 42 Example 43 W 20-95% 60-95% 20-80% Re 5~47.5% 5~40% 5~47.5% Mo 0~47.5% <0.5% 1~47.5% Cu <0.5% <0.5% <0.5% Co ≦0.002% ≦0.002% ≦0.002% Fe ≤0.02% ≤0.02% ≤0.02% Hf <0.5% <0.5% <0.5% Os <0.5% <0.5% <0.5% Nb ≤0.01% ≤0.01% ≤0.01% Pt <0.5% <0.5% <0.5% Sn ≦0.002% ≦0.002% ≦0.002% Ta <0.5% <0.5% <0.5% Tc <0.5% <0.5% <0.5% Ti <0.5% <0.5% <0.5% V <0.5% <0.5% <0.5% Zr <0.5% <0.5% <0.5% Ag 0~5% 0~5% 0~5% Al 0-5% 0-5% 0-5% Fe 0-5% 0-5% 0-5% Mg 0-5% 0-5% 0-5% Ni 0~5% 0~5% 0~5% Si 0-5% 0-5% 0-5% Ingredients / Weight % Example 44 Example 45 Example 46 Example 47 W 1~94.9% 1~94.9% 1~94.9% 10~95% Cu 0.1~94% 0.1~94% 0.1~94% 1~84% Co ≦0.002% ≦0.002% ≦0.002% ≦0.002% Fe ≦0.02% ≦0.02% ≦0.02% ≦0.02% Hf 0.1~2.5% 0~2.5% 0~2.5% 0~2.5% Os ≤ 1% ≤ 1% ≤ 1% ≤ 1% Mo 0-5% 0.1-3% 0-2% 0-3% Nb ≦0.01% ≦0.01% ≦0.01% ≦0.01% Pt ≤ 1% ≤ 1% ≤ 1% ≤ 1% Re 5~40% 5~40% 5~40% 6~40% Sn ≦0.002% ≦0.002% ≦0.002% ≦0.002% Ta 0~50% 0~50% 0~50% 0~50% Tc ≤ 1% ≤ 1% ≤ 1% ≤ 1% Ti ≤ 1% ≤ 1% ≤ 1% ≤ 1% V ≤ 1% ≤ 1% ≤ 1% ≤ 1% Zr ≤ 1% ≤ 1% ≤ 1% ≤ 1% Ag 0~5% 0~5% 0~5% 0~5% Al 0~5% 0~5% 0~5% 0~5% Fe 0~5% 0~5% 0~5% 0~5% Mg 0-5% 0-5% 0-5% 0-5% Ni 0~5% 0~5% 0~5% 0~5% Si 0~5% 0~5% 0~5% 0~5% Ingredients / Weight % Example 48 Example 49 Example 50 W 20-96% 25-92% 30-88% Cu 2-74% 2-68% 5-62% Co ≦0.002% ≦0.002% ≦0.002% Hf 0~2.5% 0~2.5% 0~2.5% Os ≤ 1% ≤ 1% ≤ 1% Mo 0-3% 0-2% 0-1% Nb ≤0.01% ≤0.01% ≤0.01% Pt ≤ 1% ≤ 1% ≤ 1% Re 6-40% 7-40% 8-40% Sn ≦0.002% ≦0.002% ≦0.002% Ta 0~50% 0.5~50% 0~50% Tc ≤ 1% ≤ 1% ≤ 1% Ti ≤ 1% ≤ 1% ≤ 1% V ≤ 1% ≤ 1% ≤ 1% Ag 0~5% 0~5% 0~5% Al 0-5% 0-5% 0-5% Fe 0-5% 0-5% 0-5% Mg 0-5% 0-5% 0-5% Ni 0~5% 0~5% 0~5% Si 0-5% 0-5% 0-5% Ingredients / Weight % Example 51 Example 52 Example 53 Example 54 W 25-88% 35-87% 40-86% 50-85% Cu 5-68% 5-57% 5-51% 5-40% Hf 0.8~1.4% 0~2.5% 0~2.5% 0~2.5% Re 0~40% 0~40% 0~40% 0~40% Ta 0~50% 0~50% 0~50% 0~50% Ingredients / Weight % Example 55 Example 56 Example 57 Ti 55~66% 65~76% 70~76% Mo 20-41% 20-31% 20-26% Re 4~20% 4~20% 4~20% Yt <0.5% <0.5% <0.5% Nb <0.5% <0.5% <0.5% Co <0.5% <0.5% <0.5% Cr <0.5% <0.5% <0.5% Zr <0.5% <0.5% <0.5% Ingredients / Weight % Example 58 Example 59 Example 60 W 20-95% 60-93% 20-80% Re 5~47.5% 7~40% 5~47.5% Mo 0~47.5% <0.5% 1~47.5% Cu <0.5% <0.5% <0.5% Co ≦0.002% ≦0.002% ≦0.002% Fe ≤0.02% ≤0.02% ≤0.02% Hf <0.5% <0.5% <0.5% Os <0.5% <0.5% <0.5% Nb ≤0.01% ≤0.01% ≤0.01% Pt <0.5% <0.5% <0.5% Sn ≦0.002% ≦0.002% ≦0.002% Ta <0.5% <0.5% <0.5% Tc <0.5% <0.5% <0.5% Ti <0.5% <0.5% <0.5% V <0.5% <0.5% <0.5% Zr <0.5% <0.5% <0.5% Ag 0~5% 0~5% 0~5% Al 0-5% 0-5% 0-5% Fe 0-5% 0-5% 0-5% Mg 0-5% 0-5% 0-5% Ni 0~5% 0~5% 0~5% Si 0-5% 0-5% 0-5% Ingredients / Weight % Example 61 Example 62 Example 63 Example 64 Ag 0~10% 0~10% 0~10% 0~10% Al 0-10% 0-10% 0-10% 2-10% B 0~10% 0~10% 0~10% 0~10% Bi 0~10% 0~10% 0~10% 0~10% Cr 2-30% 10-30% 0-20% 0-20% Cu 0~10% 0~10% 0~10% 0~10%. Co 0~10% 32~70% 0~10% 0~10% Fe 50~80% 0~20% 0~10% 0~10% Hf 0~10% 0~10% 0~10% 0~10%. Is 0~10% 0~10% 0~10% 0~10% The 0~10% 0~10% 0~10% 0~10% Mg 0~10% 0~10% 0~10% 0~10%. Mn 0~20% 0~10% 0~10% 0~10%. For 0~10% 0~30% 0~16% 0~16% Nb 0~10% 0~10% 0~10% 0~10%. Ni 0.1~30% 0.1~40% 0~10% 0~10% Os 0~10% 0~10% 0~10% 0~10% Pt 0~10% 0~10% 0~10% 0~10% Re 5~40% 4.8~40% 4.5~80% 4.5~80% Rh 0~10% 0~10% 0~10% 0~10% If 0~10% 0~10% 0~10% 0~10% Yes 0~10% 0~10% 0~10% 0~10% Sn 0~10% 0~10% 0~12% 0~12%. It is 0~10% 0~10% 0~10% 0~10%. Tc 0~10% 0~10% 0~10% 0~10%. Ti 0~10% 0~10% 70~91.5% 70~91.5% V 0~10% 0~10% 0~10% 0.01~10%. W 0~10% 0~20% 0~10% 0~10% Y 0~10% 0~10% 0~10% 0~10% Zr 0~10% 0~10% 0~10% 0~10% Ingredients / Weight % Example 65 Example 66 Example 67 Example 68 Ag 0~10% 0~10% 0~10% 0~10% Al 0~10% 0~10% 0~10% 0~10% B 0~10% 0~10% 0~10% 0~10% Bi 0~10% 0~10% 0~10% 0~10% Cr 0-10% 0-20% 0-20% 0-10% Cu 0~10% 0~10% 0~50% 0~10% Co 0~10% 0~10% 0~10% 0~10% Fe 0~10% 0~10% 0~10% 0~10% Hf 0~10% 0~10% 0~10% 0~10% Ir 0~10% 0~10% 0~10% 0~12% La 0~10% 0~10% 0~10% 0~10% Mg 0-10% 0-10% 0-10% 0-10% Mn 0~10% 0~10% 0~10% 0~10% Mo 0-55% 40-93% 0-50% 0-20% Nb 0-10% 0-10% 0-10% 40-85% Ni 0-45% 0-10% 0-10% 0-10% Os 0~10% 0~10% 0~10% 0~10% Pt 0~10% 0~10% 0~10% 0~10% Re 14~40% 7~40% 7~40% 7~40% Rh 0-10% 0-10% 0-10% 0-10% Se 0~10% 0~10% 0~10% 0~10% Si 0~10% 0~10% 0~10% 0~10% Sn 0~10% 0~10% 0~10% 0~10% Ta 35-84% 0-50% 0-50% 0-35% Tc 0~10% 0~10% 0~10% 0~10% Ti 0~10% 0~10% 0~10% 0~10% V 0~10% 0~10% 0~10% 0~10% W 0.1~25% 0~50% 14~10% 0~15% Y 0~10% 0~10% 0~10% 0~10% Zr 0~10% 0~10% 0~50% 0~10% Ingredients / Weight % Example 69 Example 70 Example 71 Example 72 Ag 0-10% 0-10% 0-5% 0-5% Al 0-10% 0-10% 0-5% 5-7% B 0~10% 0~10% 0~5% 0~5% Bi 0~10% 0~10% 0~5% 0~5% Cr 0-10% 1-95% 12-28% 0-5% Cu 0~10% 0~10% 0~5% 0~5% Co 0-10% 0-10% 36-68% 0-5% Fe 0-10% 0-10% 0-18% 0-5% Hf 0~10% 0~10% 0~5% 0~5% Ir 0~10% 0~10% 0~5% 0~5% La 0~10% 0~10% 0~5% 0~5% Mg 0-10% 0-10% 0-5% 0-5% Mn 0~10% 0~10% 0~5% 0~5% Mo 0-10% 0-20% 0-12% 0-5% Nb 0~10% 0~10% 0~5% 0~5% Ni 30-58% 0-10% 9-36% 0-5% Os 0~10% 0~10% 0~5% 0~5% Pt 0~10% 0~10% 0~5% 0~5% Re 5~40% 5~40% 4.8~40% 4.5~40% Rh 0-10% 0-10% 0-5% 0-5% Se 0~10% 0~10% 0~5% 0~5% Si 0~10% 0~10% 0~5% 0~5% Sn 0~10% 0~10% 0~5% 0~5% Ta 0~10% 0~10% 0~5% 0~5% Tc 0~10% 0~10% 0~5% 0~5% Ti 30-58% 0-40% 0-5% 70-91.5% V 0~10% 0~10% 0~5% 3~6% W 0~10% 0~10% 0~16% 0~5% Y 0~10% 0~10% 0~5% 0~5% Zr 0~10% 0~20% 0~5% 0~5% Ingredients / Weight % Example 73 Example 74 Example 75 Example 76 Location 0-8% 0-8% 0-8% 0-8% Al 0-8% 0-8% 0-8% 2-10% B 0~8% 0~8% 0~8% 0~8% Bi 0~8% 0~8% 0~8% 0~8% Cr 2-30% 10-30% 0-20% 0-20% Cu 0~8% 0~8% 0~8% 0~8% Co 0-8% 32-70% 0-8% 0-8% Fe 50-80% 0-20% 0-8% 0-8% Hf 0~8% 0~8% 0~8% 0~8% Ir 0~8% 0~8% 0~8% 0~8% La 0~8% 0~8% 0~8% 0~8% Mg 0-8% 0-8% 0-8% 0-8% Mn 0~20% 0~8% 0~8% 0~8% Mo 0-8% 0-30% 0-16% 0-16% Nb 0~8% 0~8% 0~8% 0~8% Ni 0.1~30% 0.1~40% 0~8% 0~8% Os 0~8% 0~8% 0~8% 0~8% Pt 0~8% 0~8% 0~8% 0~8% Re 5~40% 4.8~40% 4.5~80% 4.5~80% Rh 0-8% 0-8% 0-8% 0-8% Se 0~8% 0~8% 0~8% 0~8% Si 0~8% 0~8% 0~8% 0~8% Sn 0~8% 0~8% 0~12% 0~12% Ga 0~8% 0~8% 0~8% 0~8% Tc 0~8% 0~8% 0~8% 0~8% Ti 0~8% 0~8% 70~91.5% 70~91.5% V 0~8% 0~8% 0~8% 0.01~10% W 0~8% 0~20% 0~8% 0~8% Y 0~8% 0~8% 0~8% 0~8% Zr 0~8% 0~8% 0~8% 0~8% Ingredients / Weight % Example 77 Example 78 Example 79 Example 80 Location 0-8% 0-8% 0-8% 0-8% Al 0-8% 0-8% 0-8% 0-8% B 0~8% 0~8% 0~8% 0~8% Bi 0~8% 0~8% 0~8% 0~8% Cr 0-8% 0-20% 0-20% 0-8% Cu 0-8% 0-8% 0-50% 0-8% Co 0-8% 0-8% 0-8% 0-8% Fe 0~8% 0~8% 0~8% 0~8% Hf 0~8% 0~8% 0~8% 0~8% Ir 0~8% 0~8% 0~8% 0~12% La 0~8% 0~8% 0~8% 0~8% Mg 0-8% 0-8% 0-8% 0-8% Mn 0~8% 0~8% 0~8% 0~8% Mo 0-55% 40-93% 0-50% 0-20% Nb 0-8% 0-8% 0-8% 40-85% Ni 0-45% 0-8% 0-8% 0-8% Os 0~8% 0~8% 0~8% 0~8% Pt 0~8% 0~8% 0~8% 0~8% Re 14~40% 7~40% 7~40% 7~40% Rh 0-8% 0-8% 0-8% 0-8% Se 0~8% 0~8% 0~8% 0~8% Si 0~8% 0~8% 0~8% 0~8% Sn 0~8% 0~8% 0~8% 0~8% Ta 35-84% 0-50% 0-50% 0-35% Tc 0~8% 0~8% 0~8% 0~8% Ti 0~8% 0~8% 0~8% 0~8% V 0~8% 0~8% 0~8% 0~8% W 0.1~25% 0~50% 14~10% 0~15% Y 0~8% 0~8% 0~8% 0~8% Zr 0~8% 0~8% 0~50% 0~8% Ingredients / Weight % Example 81 Example 82 Example 83 Example 84 Ag 0~5% 0~5% 0~5% 0~5% Al 0-5% 0-5% 0-5% 5-7% B 0~5% 0~5% 0~5% 0~5% Bi 0~5% 0~5% 0~5% 0~5% Cr 0-5% 1-95% 12-28% 0-5% Cu 0~5% 0~5% 0~5% 0~5% Co 0-5% 0-5% 36-68% 0-5% Fe 0-5% 0-5% 0-18% 0-5% Hf 0~5% 0~5% 0~5% 0~5% Ir 0~5% 0~5% 0~5% 0~5% La 0~5% 0~5% 0~5% 0~5% Mg 0-5% 0-5% 0-5% 0-5% Mn 0~5% 0~5% 0~5% 0~5% Mo 0-5% 0-20% 0-12% 0-5% Nb 0~5% 0~5% 0~5% 0~5% Ni 30-58% 0-5% 9-36% 0-5% Os 0~5% 0~5% 0~5% 0~5% Pt 0~5% 0~5% 0~5% 0~5% Re 5~40% 5~40% 4.8~40% 4.5~40% Rh 0-5% 0-5% 0-5% 0-5% Se 0~5% 0~5% 0~5% 0~5% Si 0~5% 0~5% 0~5% 0~5% Sn 0~5% 0~5% 0~5% 0~5% Ta 0~5% 0~5% 0~5% 0~5% Tc 0~5% 0~5% 0~5% 0~5% Ti 30-58% 0-40% 0-5% 70-91.5% V 0~5% 0~5% 0~5% 3~6% W 0~5% 0~5% 0~16% 0~5% Y 0~5% 0~5% 0~5% 0~5% Zr 0~5% 0~20% 0~5% 0~5% Ingredients / Weight % Example 85 Example 86 Example 87 Example 88 Ag 0~5% 0~5% 0~5% 0~5% Al 0~5% 0~5% 0~5% 0~5% B 0~5% 0~5% 0~5% 0~5% Wind 0~5% 0~5% 0~5% 0~5%. Cr 0~5% 0~5% 0~5% 0~5%. Cu 0~5% 0~5% 0~5% 0~5%. Co 0~5% 0~5% 0~5% 0~5% Fe 0~5% 0~5% 0~5% 0~5% Hf 0~5% 0~5% 0~5% 0~5%. There is 0~5% 0~5% 0~5% 0~5%. The 0~5% 0~5% 0~5% 0~5% Mg 0~5% 0~5% 0~5% 0~5%. Mn 0~5% 0~5% 0~5% 0~5%. For 1~15% 2~10% 3~8% 0~5% Nb 0~5% 0~5% 0~5% 20~45%. It is 0~5% 0~5% 0~5% 0~5%. Os 0~5% 0~5% 0~5% 0~5% Pt 0~5% 0~5% 0~5% 0~5% Re 0~5% 0~5% 0~5% 0~5% Rh 0~5% 0~5% 0~5% 0~5%. If 0~5% 0~5% 0~5% 0~5% Yes 0~5% 0~5% 0~5% 0~5% Sn 0~5% 0~5% 0~5% 0~5%. It is 0~5% 0~5% 0~5% 1~15%. Tc 0~5% 0~5% 0~5% 0~5%. Ti 51~70% 51~70% 55~70% 51~70% V 0~5% 0~5% 0~5% 0~5%. W 0~5% 0~5% 0~5% 0~5% Y 0~5% 0~5% 0~5% 0~5% Zr 20~40% 22~38% 27~33% 1~15% Ingredients / Weight % Example 89 Example 90 Example 91 Example 92 Ag 0~5% 0~5% 0~5% 0~5% Al 0~5% 0~5% 0~5% 0~5% B 0~5% 0~5% 0~5% 0~5% Bi 0~5% 0~5% 0~5% 0~5% Cr 0~5% 0~5% 0~5% 0~5% Cu 0~5% 0~5% 0~5% 0~5% Co 0~5% 0~5% 0~5% 0~5% Fe 0~5% 0~5% 0~5% 0~5% Hf 0~5% 0~5% 0~5% 0~5% Ir 0~5% 0~5% 0~5% 0~5% La 0~5% 0~5% 0~5% 0~5% Mg 0-5% 0-5% 0-5% 0-5% Mn 0~5% 0~5% 0~5% 0~5% Mo 0~5% 0~5% 0~5% 0~5% Nb 25~40% 30~40% 25~40% 26~32% Ni 0~5% 0~5% 0~5% 0~5% Os 0~5% 0~5% 0~5% 0~5% Pt 0~5% 0~5% 0~5% 0~5% Re 0~5% 0~5% 0~5% 0~5% Rh 0-5% 0-5% 0-5% 0-5% Se 0~5% 0~5% 0~5% 0~5% Si 0~5% 0~5% 0~5% 0~5% Sn 0~5% 0~5% 0~5% 0~5% Ta 2-8% 3-6% 5-15% 10-14% Tc 0~5% 0~5% 0~5% 0~5% Ti 51~70% 52~63% 51~68% 51~62% V 0~5% 0~5% 0~5% 0~5% W 0~5% 0~5% 0~5% 0~5% Y 0~5% 0~5% 0~5% 0~5% Zr 2-12% 4-8% 2-8% 2-6% Ingredients / Weight % Example 93 Example 94 Example 95 Example 96 Ag 0~5% 0~5% 0~5% 0~5% Al 0~5% 0~5% 0~5% 0~5% B 0~5% 0~5% 0~5% 0~5% Bi 0~5% 0~5% 0~5% 0~5% Cr 0-5% 5-35% 10-30% 15-25% Cu 0~5% 0~5% 0~5% 0~5% Co 0-5% 20-55% 25-50% 35-45% Fe 0-5% 3-25% 0-5% 0-5% Hf 0~5% 0~5% 0~5% 0~5% Ir 0~5% 0~5% 0~5% 0~5% La 0~5% 0~5% 0~5% 0~5% Mg 0-5% 0-5% 0-5% 0-5% Mn 0~5% 0~5% 0~5% 0~5% Mo 0-5% 2-15% 3-12% 4-9% Nb 30-40% 0-5% 0-5% 0-5% Ni 0-5% 4-23% 5-20% 10-18% Os 0~5% 0~5% 0~5% 0~5% Pt 0~5% 0~5% 0~5% 0~5% Re 0~5% 0~5% 0~5% 0~5% Rh 0-5% 0-5% 0-5% 0-5% Se 0~5% 0~5% 0~5% 0~5% Si 0~5% 0~5% 0~5% 0~5% Sn 0~5% 0~5% 0~5% 0~5% Ta 1-3% 0-5% 0-5% 0-5% Tc 0~5% 0~5% 0~5% 0~5% Ti 51-67% 0-5% 0-5% 0-5% V 0~5% 0~5% 0~5% 0~5% W 0~5% 0~5% 0~5% 0~5% Y 0~5% 0~5% 0~5% 0~5% Zr 2~5% 0~5% 0~5% 0~5% Ingredients / Weight % Example 97 Example 98 Example 99 Example 100 Ag 0~5% 0~5% 0~5% 0~5% Al 0~5% 0~5% 0~5% 0~5% B 0~5% 0~5% 0~5% 0~5% Bi 0~5% 0~5% 0~5% 0~5% Cr 0~5% 0~5% 0~5% 0~5% Cu 0~5% 0~5% 0~5% 0~5% Co 0~5% 0~5% 0~5% 0~5% Fe 0~5% 0~5% 0~5% 0~5% Hf 0~5% 0~5% 0~5% 0~5% Ir 0~5% 0~5% 0~5% 0~5% La 0~5% 0~5% 0~5% 0~5% Mg 0-5% 0-5% 0-5% 0-5% Mn 0~5% 0~5% 0~5% 0~5% Mo 30-65% 40-60% 45-55% 0-5% Nb 0-5% 0-5% 0-5% 55-99.75% Ni 0~5% 0~5% 0~5% 0~5% Os 0~5% 0~5% 0~5% 0~5% Pt 0~5% 0~5% 0~5% 0~5% Re 0~5% 0~5% 0~5% 0~5% Rh 0-5% 0-5% 0-5% 0-5% Se 0~5% 0~5% 0~5% 0~5% Si 0~5% 0~5% 0~5% 0~5% Sn 0~5% 0~5% 0~5% 0~5% Ta 0~5% 0~5% 0~5% 0~5% Tc 0~5% 0~5% 0~5% 0~5% Ti 0~5% 0~5% 0~5% 0~5% V 0~5% 0~5% 0~5% 0~5% W 0~5% 0~5% 0~5% 0~5% Y 0~5% 0~5% 0~5% 0~5% Zr 30~56% 40~60% 45~55% 0.25~45% Ingredients / Weight % Example 101 Example 102 Example 103 Example 104 Ag 0~5% 0~5% 0~5% 0~5% Al 0~5% 0~5% 0~5% 0~5% B 0~5% 0~5% 0~5% 0~5% Bi 0~5% 0~5% 0~5% 0~5% Cr 0~5% 0~5% 0~5% 0~5% Cu 0~5% 0~5% 0~5% 0~5% Co 0~5% 0~5% 0~5% 0~5% Fe 0~5% 0~5% 0~5% 0~5% Hf 0~5% 0~5% 0~5% 0~5% Ir 0~5% 0~5% 0~5% 0~5% La 0~5% 0~5% 0~5% 0~5% Mg 0-5% 0-5% 0-5% 0-5% Mn 0~5% 0~5% 0~5% 0~5% Mo 0~5% 0~5% 0~5% 0~5% Nb 75~99.5% 95~99.25% 55~78.5% 68~74.25% Ni 0~5% 0~5% 0~5% 0~5% Os 0~5% 0~5% 0~5% 0~5% Pt 0~5% 0~5% 0~5% 0~5% Re 0~5% 0~5% 0~5% 0~5% Rh 0-5% 0-5% 0-5% 0-5% Se 0~5% 0~5% 0~5% 0~5% Si 0~5% 0~5% 0~5% 0~5% Sn 0~5% 0~5% 0~5% 0~5% Ta 0-5% 0-5% 20-35% 25-30% Tc 0~5% 0~5% 0~5% 0~5% Ti 0~5% 0~5% 0~5% 0~5% V 0~5% 0~5% 0~5% 0~5% W 0~5% 0~5% 1~8% 0~5% Y 0~5% 0~5% 0~5% 0~5% Zr 0.5~25% 0.75~5% 0.5~5% 0.75~3% Element / Weight % Example 105 Example 106 Example 107 Example 108 Re 30~75% 40~75% 45~75% 45~70% Cr 25~70% 25~65% 25~55% 30~55% Mo 0~25% 0~25% 1~25% 2~25% Bi 0~25% 0~25% 0~25% 0~25% Cr 0~25% 0~25% 0~25% 0~25% Ir 0~25% 0~25% 0~25% 0~25% Nb 0~25% 0~25% 0~25% 0~25% Ta 0~25% 0~25% 0~25% 0~25% V 0~25% 0~25% 0~25% 0~25% W 0~25% 0~25% 0~25% 0~25% Mn 0~25% 0~25% 0~25% 0~25% Tc 0~25% 0~25% 0~25% 0~25% Ru 0~25% 0~25% 0~25% 0~25% Rh 0-25% 0-25% 0-25% 0-25% Hf 0~25% 0~25% 0~25% 0~25% Os 0~25% 0~25% 0~25% 0~25% Cu 0~25% 0~25% 0~25% 0~25% Ir 0~25% 0~25% 0~25% 0~25% Ti 0~25% 0~25% 0~25% 0~25% Y 0~25% 0~25% 0~25% 0~25% Zr 0~25% 0~25% 0~25% 0~25%

[0019] In Examples 1 to 108, it will be understood that all of the above ranges include any values ​​between the above ranges and any other ranges between the ranges described above. Any of the above values ​​including the ≤ symbol include the range from 0 to the listed values, as well as all values ​​and ranges in between.

[0020] In other and / or alternative non-limiting aspects of the present disclosure, the metal alloy used to partially or completely form the frame of an artificial heart valve contains less than about 5 wt% (e.g., 0 to 4.999999 wt%, and all values ​​and ranges between them) of other metals and / or impurities, typically 0 to 1 wt%, more typically 0 to 0.1 wt%, even more typically 0 to 0.01 wt%, and even more typically 0 to 0.001 wt%. A higher purity level of the metal alloy can result in the formation of a more uniform alloy, which in turn can result in a more uniform density throughout the metal alloy, and can also result in the desired yield strength and maximum tensile strength of the metal alloy.

[0021] According to another and / or alternative aspect of this disclosure, the frame of the artificial heart valve is optionally subjected to one or more manufacturing processes. These manufacturing processes may include, but are not limited to, stretching, laser cutting, etching, crimping, annealing, stretching, Pilger rolling, electroplating, electropolishing, machining, plasma coating, 3D printing coating, chemical vapor deposition, chemical polishing, cleaning, pickling, ion beam deposition or injection, sputter coating, vacuum deposition, and the like.

[0022] According to other and / or alternative embodiments of this disclosure, the metal alloy may optionally contain certain amounts of carbon and oxygen, but this is not required. These two elements are known to influence the formation properties and brittleness of the metal alloy. A controlled atomic ratio of carbon and oxygen in the metal alloy can also minimize the tendency of the metal alloy to form microcracks during the formation of the metal alloy into the frame of an artificial heart valve and / or during the use and / or expansion of the artificial heart valve frame in the body. The carbon-to-oxygen atomic ratio can be as low as about 0.2:1 (e.g., 0.2:1 to 50:1, and all values ​​and ranges in between). In one non-limiting formulation, the atomic ratio of carbon to oxygen in the metal alloy is generally at least about 0.3:1. Typically, the carbon content of the metal alloy is less than about 0.1 wt% (e.g., 0 to 0.0999999 wt% and all values ​​and ranges in between), and more typically 0 to 0.01 wt%. If the carbon content is too high, it can negatively affect the physical properties of the metal alloy. Generally, the oxygen content should be kept at a very low level. In one non-limiting formulation, the oxygen content is less than about 0.1 wt% of the metal alloy (e.g., 0 to 0.0999999 wt% and all values ​​and ranges in between), and typically 0 to 0.01 wt%.

[0023] According to other and / or alternative aspects of this disclosure, the metal alloy may optionally contain a controlled amount of nitrogen, but this is not required. A large amount of nitrogen in the metal alloy may adversely affect the ductility of the metal alloy. This may also adversely affect the elongation properties of the metal alloy. In one non-limiting formulation, the metal alloy contains less than about 0.001 wt% of nitrogen (e.g., 0 wt% to 0.0009999 wt% and all values ​​and ranges in between). The nitrogen content is considered to be less than the carbon or oxygen content in the metal alloy. In one non-limiting formulation, the atomic ratio of carbon to nitrogen is at least about 1.5:1 (e.g., 1.5:1 to 400:1 and all values ​​and ranges in between). In another non-limiting formulation, the atomic ratio of oxygen to nitrogen is at least about 1.2:1 (e.g., 1.2:1 to 150:1 and all values ​​and ranges in between).

[0024] According to other and / or alternative aspects of the present disclosure, a metal alloy used to form all or part of the frame of an artificial heart valve is either 1) not clad, metal coated, metal sprayed, plated and / or formed (e.g., cold-worked, hot-worked, etc.) on another metal, or 2) not metal sprayed, coated, plated, clad and / or formed on the metal alloy. In some applications, it will be understood that the metal alloys of the present disclosure may be clad, metal sprayed, coated, plated and / or formed on another metal, or that another metal or metal alloy may be plated, metal sprayed, coated, clad and / or formed on the metal alloy when forming all or part of the frame of an artificial heart valve.

[0025] According to another and / or alternative aspect of this disclosure, a metal alloy can be used to a) coat all or part of the frame of an artificial heart valve (e.g., cladding, dip coating, spray coating, plating coating, weld coating, plasma coating, etc.), or b) form part or all of the core of the frame of an artificial heart valve. The composition of the coating is different from the composition of the material surface to which the metal alloy is coated. The coating thickness of the metal alloy is non-limiting (e.g., 1 μm to 1 inch, and all values ​​and ranges in between). In one non-limiting example, an artificial heart valve frame is provided, where the core or base layer of the frame of the artificial heart valve is formed of a metal or metal alloy (e.g., chromium alloy, titanium, titanium alloy, stainless steel, iron alloy, CoCr alloy, rhenium alloy, molybdenum alloy, tungsten alloy, Ta-W alloy, heat-resistant metal alloy, MoTa alloy, MoRe alloy, etc.) or a polymer or ceramic or composite material, and the other layers of the coated artificial heart valve frame are formed of different metals or metal alloys. The core or base layer and other layers of the artificial heart valve frame can each form 10–99% (and all values ​​and ranges in between) of the entire cross-section of the artificial heart valve frame. If the outer metal coating is a rhenium-containing alloy, such a rhenium alloy can be used to form a hard surface in specific locations and across the entire surface of the artificial heart valve frame. In another non-limiting embodiment, the core or base layer of the artificial heart valve frame may be formed of a rhenium-containing alloy, and the coating layer may include one or more other materials (e.g., another type of metal or metal alloy [e.g., chromium alloy, titanium, titanium alloy, stainless steel, iron alloy, CoCr alloy, rhenium alloy, molybdenum alloy, tungsten alloy, Ta-W alloy, heat-resistant metal alloy, MoTa alloy, MoRe alloy, etc.], polymer coating, ceramic coating, composite material coating, etc.).Non-limiting advantages of using rhenium-containing alloys for the core or inner layers of an artificial heart valve frame include reducing the size of the artificial heart valve frame, increasing the strength of the artificial heart valve frame, and / or maintaining or reducing the cost of the artificial heart valve frame. As can be understood, the use of rhenium-containing alloys may bring other or additional advantages. The size and / or thickness of the core or base layer of the metal alloy is non-limiting. In one non-limiting example, an artificial heart valve frame is provided which is formed at least partially from a layered material, where the top layer is formed of a different material from one or more other layers, and the rhenium-containing alloy forms one of the layers below the top layer, and the top layer is formed of a different metal (e.g., chromium alloy, titanium, titanium alloy, stainless steel, iron alloy, CoCr alloy, rhenium alloy, molybdenum alloy, tungsten alloy, Ta-W alloy, heat-resistant metal alloy, MoTa alloy, MoRe alloy, etc.). The core or lower or base layer and the outer layer of a layered material can each form 10–99% (and all values ​​and ranges in between) of the entire cross-section of the layered material.

[0026] In other and / or alternative non-limiting embodiments of the present disclosure, the mean tensile elongation of the metal alloy used to form at least partially the frame of the artificial heart valve is optionally at least about 20% (e.g., mean tensile elongation of 20–50%, as well as all values ​​and ranges in between). A mean tensile elongation of at least 20% of the metal alloy is useful in facilitating the proper expansion of the artificial heart valve frame when positioned in a therapeutic area of ​​the body. The desired tensile elongation can be obtained from a unique combination of metals in the metal alloy, in combination with achieving a desired purity and composition of the alloy as well as a desired grain size of the metal alloy.

[0027] According to another and / or alternative aspect of this disclosure, the metal alloy is optionally, but not required, formed at least partially by a swaging process. In one non-limiting embodiment, swaging is performed on the metal alloy to achieve at least partially or completely the final dimensions of one or more parts of the frame of the artificial heart valve. The swaging die can be, but not required, formed to conform to the final dimensions of the frame of the artificial heart valve.

[0028] According to other and / or alternative embodiments of this disclosure, the metal alloy may optionally be nitrided, but is not required. The nitrided layer on the metal alloy may serve as a lubricating surface during the optional stretching of the metal alloy when partially or completely forming the frame of an artificial heart valve.

[0029] According to other and / or alternative, non-limiting aspects of this disclosure, the frame of an artificial heart valve may optionally be partially (e.g., 1% to 99.99%, and all values ​​and ranges in between) or completely coated with one or more agents, and / or may contain such agents. If one or more agents are coated onto the artificial heart valve and the artificial heart valve includes a reinforcement coating, the one or more agents are generally coated on the outer surface of the reinforcement coating. The term “agent” includes, but is not limited to, substances, pharmaceuticals, biological, veterinary products, drugs, and analogues or derivatives that are otherwise formulated and / or designed to prevent, inhibit and / or treat and / or promote the healing of one or more clinical and / or biological events. Non-exclusive examples of clinical events that can be addressed by one or more drugs include, but are not limited to, viral infections, fungal infections and / or bacterial infections; vascular diseases and / or vascular disorders; lymphatic diseases and / or lymphatic disorders; cancer; transplant rejection; pain; nausea; swelling; organ failure; immune disorders and / or immune disorders; cell proliferation inhibitors, hematological disorders and / or hematological disorders; heart diseases and / or heart disorders; neuralgia disorders and / or neuralgia disorders; fatigue; genetic disorders and / or genetic disorders; trauma; seizures; muscle spasms; tissue repair; nerve repair; and nerve regeneration.

[0030] The type and / or amount of the drugs included in the coating of the artificial heart valve frame can be modified. According to another and / or alternative aspect of the present disclosure, one or more parts of the artificial heart valve frame may optionally have one or more parts of the artificial heart valve frame that 1) contain the same or different drugs, 2) contain the same or different amounts of one or more drugs, 3) contain the same or different polymer coatings, 4) contain one or more polymer coatings of the same or different coating thicknesses, 5) release one or more drugs in a controllable manner and / or uncontrollably, and / or 6) have one or more parts of the artificial heart valve frame that release one or more drugs in a controllable manner and / or uncontrollably.

[0031] According to another and / or alternative aspect of this disclosure, one or more surfaces of the artificial heart valve frame can be optionally treated to achieve desired coating properties of one or more agents and / or polymers coated on the artificial heart valve frame. Such surface treatment techniques include, but are not limited to, cleaning, buffing, smoothing, nitriding, annealing, swaging, cold working, and etching (chemical etching, plasma etching, etc.). As can be understood, other or additional surface treatment processes may be used before coating one or more agents and / or polymers onto the surface of the artificial heart valve frame.

[0032] In other and / or alternative non-limiting embodiments of the present disclosure, the frame of the artificial heart valve may optionally include a marker material that facilitates the proper positioning of the frame of the artificial heart valve within a body passage. The marker material is typically designed to be visible to electromagnetic waves (e.g., X-rays, microwaves, visible light, infrared waves, ultraviolet waves, etc.), sound waves (e.g., ultrasound, etc.), magnetic waves (e.g., MRI, etc.), and / or other types of electromagnetic waves (e.g., microwaves, visible light, infrared waves, ultraviolet waves, etc.).

[0033] According to another and / or alternative aspect of this disclosure, the frame of an artificial heart valve or one or more regions of the frame of an artificial heart valve may optionally be constructed using one or more micro-electromechanical (MEMS) technologies (e.g., micromachining, laser micromachining, micromolding, etc.), but other or additional manufacturing technologies may be used.

[0034] According to another and / or alternative aspect of this disclosure, the frame of an artificial heart valve may optionally include one or more surface structures (e.g., pores, channels, pits, ribs, slots, notches, bumps, teeth, needles, wells, holes, grooves, etc.). These structures may be formed at least partially by MEMS (e.g., micromachining, etc.) technology and / or other types of technology.

[0035] According to another and / or alternative aspect of this disclosure, the frame of an artificial heart valve may optionally include one or more microstructures on the surface of the frame of the artificial heart valve (e.g., microneedles, micropores, microcylinders, microcones, micropyramids, microtubes, microparallelohedrons, microprisms, microhemispheries, teeth, ribs, protrusions, ratchets, hinges, zippers, cable tie-like structures, etc.). As defined herein, “microstructure” is a structure having at least one dimension (e.g., average width, average diameter, average height, average length, average depth, etc.) which is about 2 mm or less and typically about 1 mm or less.

[0036] In other and / or alternative embodiments of this disclosure, the frame of the artificial heart valve may optionally be an expandable device that can be expanded using several other devices (e.g., balloons). The frame of the artificial heart valve may be manufactured from a material that does not have or substantially has shape memory properties.

[0037] According to another and / or alternative aspect of the present disclosure, a near-net process for the frame of an artificial heart valve is provided, optionally. In one non-limiting embodiment of the present disclosure, a method is provided for increasing the strength after sintering by powder pressing a material and imparting additional cold working. In one non-limiting embodiment, an unsintered part is pressed and then sintered. The sintered part is then pressed again, and its mechanical strength is increased by imparting cold working to the pressed and sintered part.

[0038] According to other and / or alternative aspects of this disclosure, the metal alloy used to form at least partially the frame of the artificial heart valve may optionally be first formed into a blank, rod, tube, etc., and then finished to a final form by one or more finishing processes. The metal alloy blank, rod, tube, etc. may be formed by a variety of techniques, but are not limited to: 1) melting the metal alloy and / or the metal forming the metal alloy (e.g., vacuum arc melting), and then extruding and / or casting the metal alloy into a blank, rod, tube, etc.; 2) melting the metal alloy and / or the metal forming the metal alloy to form a metal strip, and then rolling and welding the strip into a blank, rod, tube, etc.; 3) compacting the metal powder of the metal alloy and / or the metal forming the metal alloy into a blank, rod, tube, etc.; or 4) 3-D printing the metal powder of the metal alloy and / or the metal forming the metal alloy into a blank, rod, tube, etc., etc. When the metal alloy is formed into a blank, the shape and size of the blank are not limited.

[0039] In other and / or alternative embodiments of this disclosure, when metal powders are compacted to form a metal alloy into blanks, rods, tubes, etc., the metal powders are pressed together to form a solid solution of the metal alloy into a nearnet frame of an artificial heart valve, a nearnet component of an artificial heart valve frame, a blank, rod, tube, etc. Typically, the pressing process is by isotropic process (i.e., uniform pressure is applied from all sides of the metal powder), but other processes can be used. When the metal powders are pressed together isotropically, cold isotropic pressing (CIP) is typically used to compact the metal powders, but this is not mandatory. The pressing process can be carried out in an inert atmosphere, an oxygen-reducing atmosphere (e.g., a mixture of hydrogen, argon, and hydrogen), and / or under vacuum, but this is not mandatory.

[0040] According to another and / or alternative aspect of this disclosure, when metal powder is used to 3D print artificial heart valve frames, components of artificial heart valve frames, blanks, rods, tubes, etc., the average particle size of the metal powder is optionally 2 to 62 microns, and more specifically, about 5 to 49.9 microns, and the average density of the metal powder is 5 g / cm³ 3 Larger than that, the metal powder is approximately spherical in shape, and the whole flow (seconds / 50g) is less than 30 seconds (e.g., 2 to 29.99 seconds, as well as all values ​​and ranges in between).

[0041] According to other and / or alternative non-limiting aspects of this disclosure, the frame of an artificial heart valve may be partially (e.g., 1% to 99.99%, as well as all values ​​and ranges in between) or completely coated with a reinforcing coating to improve one or more properties of the frame of the artificial heart valve (e.g., changing the appearance color of the material having a coated surface, increasing the surface hardness by using a coated surface, increasing the surface toughness of the material having a coated surface, reducing friction by using a coated surface, improving the scratch resistance of the material having a coated surface, improving the impact abrasion of the coated surface, improving the resistance of the coated material to corrosion and oxidation, forming a non-adherent coated surface, improving the biocompatibility of the material having a coated surface, reducing the toxicity of the material having a coated surface, reducing ion emission from the material having a coated surface, the reinforcing coating forming a less irritating surface to cells around the coated surface after the artificial heart valve frame is implanted, etc.). Non-limiting reinforcing coatings that can be applied to part or all of the frame of an artificial heart valve include chromium nitride (CrN), diamond-like carbon (DLC), titanium nitride (TiN), titanium oxide nitride (TiNOx), zirconium nitride (ZrN), zirconium oxide (ZrO2), zirconium nitrogen-carbon (ZrNC), zirconium oxycarbide (ZrOC), zirconium oxynitride (ZnNxOy) [e.g., cubic ZrN:O, cubic ZrO2:N, tetragonal ZrO2:N, and monoclinic ZrO2:N phase coatings], and combinations of such coatings. In one non-limiting embodiment, one or more reinforcing coatings are optionally applied to part or all of the frame of an artificial heart valve by a vacuum process that uses an energy source to evaporate the material and deposit a thin layer of the reinforcing coating material. Such vacuum coating processes (if used) may include physical vapor deposition (PVD) processes (e.g., sputter deposition, cathode arc deposition, or electron beam heating), chemical vapor deposition (CVD) processes, atomic layer deposition (ALD) processes, or plasma-enhanced chemical vapor deposition (PE-CVD) processes.In one non-limiting embodiment, the coating process is one or more of PVD, CVD, ALD, and PE-CVD, and the coating process is carried out at a temperature of 200–400°C (and all values ​​and ranges therein) for at least 10 minutes (e.g., 10–400 minutes and all values ​​and ranges therein). In another non-limiting embodiment, the coating process is one or more of PVD, CVD, ALD, and PE-CVD, and the coating process is carried out at a temperature of 220–300°C for 60–120 minutes. In another non-limiting embodiment, if one or more reinforcing coating materials are applied to the outer surface of an artificial heart valve frame partially or completely formed of a metal alloy, the one or more reinforcing coating materials may optionally be combined with one or more metals in the metal alloy, and / or with nitrogen, oxygen, carbon, or other elements present in and / or in the atmosphere around the metal alloy to form a reinforcing coating on the outer surface of the metal alloy. In another non-limiting embodiment, when one or more reinforcing coating materials are applied to the outer surface of an artificial heart valve frame partially or completely formed of a metal alloy, the one or more reinforcing coating materials can optionally be used to form a variety of coating colors (e.g., gold, copper, brass, black, rose gold, chromium, blue, silver, yellow, green, etc.) on the outer surface of the metal alloy. In another non-limiting embodiment, the thickness of the reinforcing coating is greater than 1 nanometer (e.g., 2 nanometers to 100 microns, and all values ​​and ranges in between), and typically 0.1 to 25 microns, and more typically 0.2 to 10 microns. In another non-limiting embodiment, the hardness of the reinforcing coating can be at least 5 GPa (ASTM C1327-15 or ASTM C1624-05), typically 5 to 50 GPa (and all values ​​and ranges in between), more typically 10 to 25 GPa, and even more typically 14 to 24 GPa. In another non-limiting embodiment, the coefficient of friction (COF) of the reinforced coating can be 0.04 to 0.2 (and all values ​​and ranges in between), and typically 0.6 to 0.15.In another non-limiting embodiment, the wear rate of the reinforced coating can be 0.5 × 10⁻⁷ mm³ / Nm to 3 × 10⁻⁷ mm³ / Nm (all values ​​and ranges in between), and typically 1.2 × 10⁻⁷ mm³ / Nm to 2 × 10⁻⁷ mm³ / Nm. In another non-limiting embodiment, silicon-based precursors (e.g., trimethylsilane, tetramethylsilane, hexachlorodisilane, silane, dichlorosilane, trichlorosilane, silicon tetrachloride, tris(dimethylamino)silane, bis(tert-butylamino)silane, trisilylamine, allyltrimethoxysilane, (3-aminopropyl)triethoxysilane, butyltrichlorosilane, n-sec-butyl(trimethylsilyl)amine, chloropentamethyldisilane, 1,2-dichlorotetramethyldisilane, [3-(diethylamino)pro [Pill]trimethoxysilane, 1,3-diethyl-1,1,3,3-tetramethyldisilazane, dimethoxydimethylsilane, dodecamethylcyclohexasilane, hexamethyldisilane, isobutyl(trimethoxy)silane, methyltrichlorosilane, 2,4,6,8,10-pentamethylcyclopentasiloxane, pentamethyldisilane, n-propyltriethoxysilane, silicon tetrabromide, silicon tetrabromide, etc. can optionally be used to facilitate the application of a reinforcing coating to one or more or all of the frame of an artificial heart valve.

[0042] According to another and / or alternative non-limiting aspect of the present disclosure, the frame of an artificial heart valve can be partially or completely coated with a reinforcing coating composition comprising a chromium nitride (CrN) coating. Partial or complete coating of the frame of an artificial heart valve can be partially or completely coated with a chromium nitride (CrN) coating. The reinforcing coating can be used to improve hardness, improve toughness, reduce friction, resist impact wear, improve resistance to corrosion and oxidation, and / or form a reduced adhesion surface when in contact with many different materials. According to one non-limiting embodiment, the chromium nitride (CrN) coating generally comprises 40–85 wt% Cr (and all values ​​and ranges in between), 15–60 wt% N (and all values ​​and ranges in between), 0–10 wt% Re (and all values ​​and ranges in between), 0–10 wt% Si (and all values ​​and ranges in between), 0–2 wt% O (and all values ​​and ranges in between), and 0–2 wt% C (and all values ​​and ranges in between). In one non-limiting coating process, all or part of the frame of the artificial heart valve is first coated with Cr metal. The Cr metal coating can be applied by PVD, CVD, ALD, and PE-CVD in an inert environment. The thickness of the Cr metal coating is 0.5 to 15 microns. Subsequently, the Cr metal coating is exposed to nitrogen gas and / or nitrogen-containing gas compounds to react with nitrogen in the Cr metal coating, forming a layer of CrN on the outer surface of the Cr metal coating and / or the outer surface of the frame of the artificial heart valve. Cr metal particles can optionally be mixed with nitrogen gas and / or nitrogen-containing gas compounds to facilitate the formation of the CrN coating. When Cr metal particles are used, the initial Cr coating layer on the frame of the artificial heart valve can optionally be omitted. In another non-limiting embodiment, the reinforced coating composition generally contains 65 to 80% by weight of Cr, 15 to 30% by weight of N, 0 to 8% by weight of Re, 0 to 1% by weight of Si, 0 to 1% by weight of O, and 0 to 1% by weight of C.

[0043] According to another and / or alternative non-limiting aspect of the present disclosure, the frame of an artificial heart valve may be partially or completely coated with a reinforcing coating composition comprising a diamond-like carbon (DLC) coating. Partial or complete coatings of the frame of an artificial heart valve may be partially or completely coated with a diamond-like carbon (DLC) coating. The reinforcing coating can be used to improve hardness, improve toughness, reduce friction, resist impact wear, improve resistance to corrosion and oxidation, improve biocompatibility, and / or form a reduced adhesion surface when in contact with many different materials. In one non-limiting embodiment, the diamond-like carbon (DLC) coating generally comprises 60–99.99% by weight of C (and all values ​​and ranges in between), 0–2% by weight of N (and all values ​​and ranges in between), 0–10% by weight of Re (and all values ​​and ranges in between), 0–20% by weight of Si (and all values ​​and ranges in between), and 0–2% by weight of O (and all values ​​and ranges in between). Carbon coatings can be applied by PVD, CVD, ALD, and PE-CVD in an inert environment. The carbon layer can be applied using methane and / or acetylene gas, but other or additional carbon sources can be used. The carbon coating thickness is 0.5 to 15 microns. In another non-limiting embodiment, all or part of the frame of an artificial heart valve is generally coated with a reinforcing coating composition containing 90 to 99.99% by weight of C, 0 to 1% by weight of N, 0 to 8% by weight of Re, 0 to 1% by weight of Si, and 0 to 1% by weight of O.

[0044] According to another and / or alternative non-limiting aspect of this disclosure, the frame of an artificial heart valve can be partially or completely coated with a reinforcing coating composition comprising a titanium nitride (TiN) coating. Partial or all of the outer surface of the artificial heart valve frame may include a titanium nitride (TiN) coating. The reinforcing coating can be used to improve hardness, improve toughness, improve resistance to corrosion and oxidation, reduce friction, and / or form a reduced adhesion surface when in contact with many different materials. In one non-limiting embodiment, all or part of the outer surface of the artificial heart valve frame is optionally first coated with Ti metal. The Ti metal coating can be applied by PVD, CVD, ALD and PE-CVD in an inert environment, if applicable. The thickness of the Ti metal coating is 0.05 to 15 microns (and all values ​​and ranges in between). As can be understood, the initial Ti coating is optional. Subsequently, the Ti metal coating, if applied, is exposed to nitrogen gas and / or nitrogen-containing gaseous compounds and optionally titanium particles to react the nitrogen with the Ti metal coating and / or titanium metal particles, forming a TiN layer on the outer surface of the Ti metal coating and / or the outer surface of the artificial heart valve frame. If the titanium layer is not pre-applied, the TiN coating can be formed by exposing the artificial heart valve frame to titanium particles and nitrogen gas and / or nitrogen-containing gaseous compounds. The coating thickness of the TiN coating is generally 0.1 to 15 microns (and all values ​​and ranges in between), and typically 0.2 to 2 microns.

[0045] According to another and / or alternative non-limiting aspect of this disclosure, the frame of an artificial heart valve can be partially or completely coated with a reinforcing coating composition comprising a titanium nitride (TiNOx) coating. Partial or all of the outer surface of the artificial heart valve frame may include a titanium nitride (TiNOx) coating. The reinforcing coating can be used to improve hardness, improve toughness, improve resistance to corrosion and oxidation, reduce friction, and / or form a reduced adhesion surface when in contact with many different materials. In one non-limiting embodiment, all or part of the outer surface of the artificial heart valve frame is optionally first coated with Ti metal. The Ti metal coating can be applied by PVD, CVD, ALD and PE-CVD in an inert environment, if applicable. The thickness of the Ti metal coating is 0.05 to 15 microns (and all values ​​and ranges in between). As can be understood, the initial Ti coating is optional. Subsequently, the Ti metal coating is exposed to titanium particles and a nitrogen and oxygen mixture, which may include nitrogen gas, oxygen gas, nitrogen-containing gas compounds, and / or oxygen-containing gas compounds, to react the nitrogen and oxygen with the Ti metal coating (if such a coating is used), and / or with the Ti metal particles, forming a TiNOx layer on the outer surface of the Ti metal coating and / or the outer surface of the artificial heart valve frame. The N to O ratio can be varied to control the amount of O in the TiNOx coating. If the titanium layer is not pre-applied, the TiNOx coating can be formed by exposing the artificial heart valve frame to titanium particles and a nitrogen and oxygen source such as nitrogen gas, oxygen gas, nitrogen-containing gas compounds, and / or oxygen-containing gas compounds. The N to O ratio when forming the TiNOx coating is generally 1:10 to 10:1 (and all values ​​and ranges in between). The coating thickness of the TiNOx coating is generally 0.1 to 15 microns (and all values ​​and ranges in between), and typically 0.2 to 2 microns.In another non-limiting embodiment, the TiNOx coating is applied to part or all of the outer surface of the frame of an artificial heart valve, and the TiNOx coating is formed by a) exposing the outer surface of all parts of the frame of the artificial heart valve to Ti particles (PVD, CVD, ALD, and PE-CVD processes) and / or a Ti-containing solution to form a Ti layer on all parts of the frame of the artificial heart valve, with a Ti coating thickness of 0.05 to 5 microns, or b) exposing the Ti coating to a nitrogen and oxygen source such as nitrogen gas, oxygen gas, nitrogen-containing gaseous compounds, and / or oxygen-containing gaseous compounds to form a TiNOx coating, with an N to O ratio when forming the TiNOx coating generally being 1:10 to 10:1, and a coating thickness of the TiNOx coating being 0.2 to 5 microns. In another non-limiting embodiment, the TiNOx coating is applied to a portion or all of the outer surface of the frame of an artificial heart valve, and the TiNOx coating is formed by exposing a portion or all of the outer surface of the frame of the artificial heart valve to Ti particles and a nitrogen and oxygen source such as nitrogen gas, oxygen gas, nitrogen-containing gaseous compounds, and / or oxygen-containing gaseous compounds, the N to O ratio when forming the TiNOx coating is generally 1:10 to 10:1, and the coating thickness of the TiNOx coating is 0.2 to 5 microns. In another non-limiting embodiment, the reinforcing coating composition generally comprises 20 to 85 wt% Ti (and all values ​​and ranges therein), 0.5 to 35 wt% N (and all values ​​and ranges therein), 0 to 10 wt% Re (and all values ​​and ranges therein), and 0.5 to 35 wt% O (and all values ​​and ranges therein). In another non-limiting embodiment, a TiNOx coating was formed on the frame of the artificial heart valve by a reaction physical vapor deposition method in a vacuum chamber. Depending on the oxygen-nitrogen ratio during deposition, a TiNOx coating deposit with a specified composition and resistivity can be coated onto the outer surface of the frame of the artificial heart valve.

[0046] According to another and / or alternative non-limiting aspect of the present disclosure, the frame of an artificial heart valve can be partially or completely coated with a reinforcing coating composition comprising a zirconium nitride (ZrN) coating. The reinforcing coating can be used to improve hardness, improve toughness, improve resistance to corrosion and oxidation, reduce friction, and / or form a reduced adhesion surface when in contact with many different materials. In one non-limiting embodiment, all or part of the outer surface of the artificial heart valve frame is first coated with Zr metal. The Zr metal coating can be applied by PVD, CVD, ALD and PE-CVD in an inert environment. The thickness of the Zr metal coating is 0.5 to 15 microns. The Zr metal coating is then exposed to nitrogen gas and / or nitrogen-containing gas compounds to react nitrogen with the Zr metal coating, forming a layer of ZrN on the outer surface of the Zr metal coating and / or the outer surface of the artificial heart valve frame. Zr metal particles can optionally be mixed with nitrogen gas and / or nitrogen-containing gas compounds to facilitate the formation of the ZrN coating. When Zr metal particles are used, the first Zr coating layer on the frame of the artificial heart valve can be optionally omitted. ZrN coating has been found to produce a golden reinforced coating color. In another non-limiting embodiment, the reinforced coating composition generally comprises 35–90 wt% Zr (and all values ​​and ranges in between), 5–25 wt% N (and all values ​​and ranges in between), 0–10 wt% Re (and all values ​​and ranges in between), 0–20 wt% Si (and all values ​​and ranges in between), 0–2 wt% O (and all values ​​and ranges in between), and 0–2 wt% C (and all values ​​and ranges in between). In another non-limiting embodiment, the reinforced coating composition generally comprises 80–90 wt% Zr, 10–20 wt% N, 0–8 wt% Re, 0–1 wt% Si, 0–1 wt% O, and 0–1 wt% C.

[0047] According to another and / or alternative non-limiting aspect of the present disclosure, the frame of an artificial heart valve can be partially or completely coated with a reinforcing coating composition comprising a zirconium oxide (ZrO2) coating. The reinforcing coating can be used to improve hardness, improve toughness, improve resistance to corrosion and oxidation, reduce friction, and / or form a reduced adhesion surface when in contact with many different materials. In one non-limiting embodiment, all or part of the outer surface of the artificial heart valve frame is first coated with Zr metal. The Zr metal coating can be applied by PVD, CVD, ALD and PE-CVD in an inert environment. The thickness of the Zr metal coating is 0.5 to 15 microns. The Zr metal coating is then exposed to oxygen gas and / or oxygen-containing gas compounds to react the oxygen with the Zr metal coating, forming a layer of zirconium oxide (ZrO2) on the outer surface of the Zr metal coating and / or the outer surface of the artificial heart valve frame. Zr metal particles can optionally be mixed with oxygen gas and / or oxygen-containing gas compounds to facilitate the formation of a ZrO2 coating. When Zr metal particles are used, the initial Zr coating layer on the frame of the artificial heart valve can optionally be omitted. Zirconium oxide (ZrO2) coatings have been found to produce a blue reinforced coating color. In another non-limiting embodiment, the reinforced coating composition generally comprises 35–90 wt% Zr (and all values ​​and ranges in between), 10–35 wt% O (and all values ​​and ranges in between), 0–2 wt% N (and all values ​​and ranges in between), 0–10 wt% Re (and all values ​​and ranges in between), 0–20 wt% Si (and all values ​​and ranges in between), and 0–2 wt% C (and all values ​​and ranges in between). In another non-limiting embodiment, the reinforcing coating composition generally comprises 70-80% by weight of Zr, 20-30% by weight, 0-1% by weight of N, 0-8% by weight of Re, 0-1% by weight of Si, and 0-1% by weight of C.

[0048] According to another and / or alternative non-limiting aspect of the present disclosure, the frame of an artificial heart valve can be partially or completely coated with a reinforcing coating composition comprising both zirconium oxide (ZrO2) coating and zirconium nitride (ZrN) coating. The reinforcing coating can be used to improve hardness, improve toughness, improve resistance to corrosion and oxidation, reduce friction, and / or form a reduced adhesion surface when in contact with many different materials. In one non-limiting embodiment, all or part of the outer surface of a metal alloy is first coated with Zr metal. The Zr metal coating can be applied by PVD, CVD, ALD and PE-CVD in an inert environment. The thickness of the Zr metal coating is 0.5 to 15 microns. Subsequently, the Zr metal coating is exposed to a) both oxygen gas and / or oxygen-containing gas compounds and nitrogen gas and / or nitrogen-containing gas compounds, b) nitrogen gas and / or nitrogen-containing gas compounds followed by oxygen gas and / or oxygen-containing gas compounds, or c) oxygen gas and / or oxygen-containing gas compounds followed by nitrogen gas and / or nitrogen-containing gas compounds. The coating compositions of zirconium oxide (ZrO2) coatings and zirconium nitride (ZrN) coatings are similar to or the same as those discussed above. As discussed above, Zr metal particles can be optionally mixed with oxygen gas and / or oxygen-containing gas compounds to facilitate the formation of a ZrO2 coating, and with nitrogen gas and / or nitrogen-containing gas compounds to facilitate the formation of a ZrN coating. When Zr metal particles are used, the first Zr coating layer on the artificial heart valve frame can be optionally omitted.

[0049] According to another and / or alternative non-limiting aspect of this disclosure, the frame of an artificial heart valve can be partially or completely coated with a reinforcing coating composition comprising a zirconium oxycarbide (ZrOC) coating. The reinforcing coating can be used to improve hardness, improve toughness, improve resistance to corrosion and oxidation, reduce friction, and / or form a reduced adhesion surface when in contact with many different materials. In one non-limiting embodiment, all or part of the outer surface of a metal alloy is first coated with Zr metal. The Zr metal coating can be applied by PVD, CVD, ALD and PE-CVD in an inert environment. The thickness of the Zr metal coating is 0.5 to 15 microns. Subsequently, the Zr metal coating is exposed to a) both oxygen gas and / or oxygen-containing gas compounds and carbon and / or carbon-containing gas compounds (e.g., methane and / or acetylene gas), b) carbon and / or carbon-containing gas compounds followed by oxygen gas and / or oxygen-containing gas compounds, or c) oxygen gas and / or oxygen-containing gas compounds followed by carbon and / or carbon-containing gas compounds. Zr metal particles can optionally be mixed with oxygen gas and / or oxygen-containing gas compounds and carbon and / or carbon-containing gas compounds to facilitate the formation of a zirconium oxycarbide (ZrOC) coating. When Zr metal particles are used, the initial Zr coating layer on the artificial heart valve frame can optionally be omitted. In another non-limiting embodiment, the reinforcing coating composition generally comprises 40–95 wt% Zr (and all values ​​and ranges therein), 5–25 wt% O (and all values ​​and ranges therein), 10–40 wt% C (and all values ​​and ranges therein), 0–2 wt% N (and all values ​​and ranges therein), 0–10 wt% Re (and all values ​​and ranges therein), and 0–20 wt% Si (and all values ​​and ranges therein).In another non-limiting embodiment, the reinforcing coating composition generally comprises 40-65% by weight of Zr, 5-25% by weight of O, 25-40% by weight of C, 0-1% by weight of N, 0-8% by weight of Re, and 0-1% by weight of Si.

[0050] According to another and / or alternative non-limiting aspect of the present disclosure, one or more components of the artificial heart valve frame may be partially or completely coated with a reinforcing coating composition comprising zirconium oxynitride (ZnNxOy) [e.g., cubic ZrN:O, cubic ZrO2:N, tetragonal ZrO2:N, and monoclinic ZrO2:N phase coatings]. Part or all of the outer surface of one or more components of the artificial heart valve frame may contain zirconium oxynitride (ZnNxOy). The reinforcing coating can be used to improve hardness, improve toughness, improve resistance to corrosion and oxidation, reduce friction, form a reduced adhesion surface when in contact with many different materials, and / or promote nitric oxide formation on the surface of the coating. In one non-limiting embodiment, all or part of the outer surface of one or more components of the artificial heart valve frame may be optionally first coated with Zr metal. The Zr metal coating may be applied by PVD, CVD, ALD, and PE-CVD in an inert environment, if applicable. The coating thickness of the Zr metal is 0.05 to 15 microns (and all values ​​and ranges in between). As can be understood, the initial Zr coating is optional. Subsequently, the Zr metal coating is exposed to a nitrogen and oxygen mixture, which may include zirconium particles and nitrogen gas, oxygen gas, nitrogen-containing gas compounds, and / or oxygen-containing gas compounds, to react the nitrogen and oxygen with the Zr metal coating, and / or Zr metal particles, if a Zr metal coating is used, to form a layer of ZnNxOy on the outer surface of the Zr metal coating and / or the outer surface of one or more components of the artificial heart valve frame. The N to O ratio can be varied to control the proportion of O and N in the ZrNxOy coating. If the zirconium layer is not pre-applied, the ZrNxOy coating can be formed on the outer surface of one or more components of the artificial heart valve frame by exposing the outer surface of one or more components of the artificial heart valve frame to zirconium particles and a nitrogen and oxygen source such as nitrogen gas, oxygen gas, nitrogen-containing gas compounds, and / or oxygen-containing gas compounds.The N-to-O ratio when forming a ZrNxOy coating is generally 1:10 to 10:1 (and all values ​​and ranges in between). The coating thickness of a ZrNxOy coating is generally 0.1 to 15 microns (and all values ​​and ranges in between), and typically 0.2 to 2 microns. In another non-limiting embodiment, the ZrNxOy coating is applied to part or all of the outer surface of one or more components of the frame of an artificial heart valve, and the ZrNxOy coating is formed by a) exposing the outer surface of all parts of one or more components of the frame of the artificial heart valve to Zr particles (PVD, CVD, ALD and PE-CVD processes) and / or a Zr-containing solution to form a Zr layer on all parts of one or more components of the frame of the artificial heart valve, with a thickness of 0.05 to 5 microns, or b) exposing the Zr coating to a nitrogen and oxygen source such as nitrogen gas, oxygen gas, nitrogen-containing gas compounds and / or oxygen-containing gas compounds to form the ZrNxOy coating, with an N to O ratio when forming the ZrNxOy coating generally being 1:10 to 10:1, and a coating thickness of 0.2 to 5 microns. In another non-limiting embodiment, the ZrNxOy coating is applied to part or all of the outer surface of one or more components of the frame of an artificial heart valve, and the ZrNxOy coating is formed by exposing part or all of the outer surface of one or more components of the frame of an artificial heart valve to Zr particles and a nitrogen and oxygen source such as nitrogen gas, oxygen gas, nitrogen-containing gaseous compounds, and / or oxygen-containing gaseous compounds, the N to O ratio when forming the ZrNxOy coating is generally 1:10 to 10:1, and the coating thickness of the ZrNxOy coating is 0.2 to 5 microns. In another non-limiting embodiment, the reinforcing coating composition generally comprises 20 to 85 wt% Zr (and all values ​​and ranges in between), 0.5 to 35 wt% N (and all values ​​and ranges in between), and 0.5 to 35 wt% O (and all values ​​and ranges in between).In another non-limiting embodiment, a ZrNxOy coating was formed on one or more components of the artificial heart valve frame by reactive physical deposition in a vacuum chamber. Depending on the oxygen-nitrogen ratio during deposition, a ZrNxOy coating deposit with a specified composition and resistivity can be coated onto the outer surface of one or more components of the artificial heart valve frame.

[0051] According to another and / or alternative non-limiting aspect of the present disclosure, the frame of an artificial heart valve can be partially or completely coated with a reinforcing coating composition comprising a zirconium-nitrogen-carbon (ZrNC) coating. The reinforcing coating can be used to improve hardness, improve toughness, improve resistance to corrosion and oxidation, reduce friction, and / or form a reduced adhesion surface when in contact with many different materials. In one non-limiting embodiment, all or part of the outer surface of the frame of an artificial heart valve is first coated with Zr metal. The Zr metal coating can be applied by PVD, CVD, ALD and PE-CVD in an inert environment. The thickness of the Zr metal coating is 0.5 to 15 microns. The Zr metal coating is then exposed to nitrogen gas and / or nitrogen-containing gaseous compounds, and then to carbon and / or carbon-containing gaseous compounds (e.g., methane and / or acetylene gas). The color of the ZrNC varies depending on the amount of C and N in the coating. Zr metal particles can be optionally mixed with nitrogen gas and / or nitrogen-containing gas compounds and carbon and / or carbon-containing gas compounds to facilitate the formation of the ZrNC coating. When Zr metal particles are used, the first Zr coating layer on the frame of the artificial heart valve can be optionally omitted. In one non-limiting embodiment, the reinforced coating composition generally comprises 40–95 wt% Zr (and all values ​​and ranges in between), 5–40 wt% N (and all values ​​and ranges in between), 5–40 wt% C (and all values ​​and ranges in between), 0–2 wt% O (and all values ​​and ranges in between), 0–10 wt% Re (and all values ​​and ranges in between), and 0–20 wt% Si (and all values ​​and ranges in between). In another non-limiting embodiment, the reinforcing coating composition generally comprises 40-80% by weight of Zr, 5-25% by weight of N, 5-25% by weight of C, 0-1% by weight of O, 0-8% by weight of Re, and 0-1% by weight of Si.

[0052] According to another and / or alternative non-limiting aspect of the present disclosure, an artificial heart valve is provided comprising an expandable frame, a leaflet structure supported by the frame, and an optional inner skirt fixed to the surface of the frame and / or the leaflet structure. The artificial heart valve may be implanted in the annulus of a natural aortic valve, but it may also be configured to be implanted in other valves of the heart (e.g., tricuspid valve, pulmonary valve, mitral valve). The artificial heart valve has a “lower” end and an “upper” end, the lower end of the artificial heart valve being the inlet end and the upper end being the outlet end.

[0053] According to another and / or alternative, non-limiting aspect of the present disclosure, an expandable frame of an artificial heart valve is configured to be radially foldable into a folded or crimped state for introduction into the body (e.g., into a delivery catheter, etc.) and radially expandable into an expanded state for implantation of the artificial heart valve at a desired location in the heart (e.g., the aortic valve, tricuspid valve, pulmonary valve, mitral valve, etc.). The expandable frame of the artificial heart valve is formed of a plastically expandable material that allows the frame to be crimped into a smaller profile for delivery of the frame and expansion at the treatment site. Expansion of the crimped frame of the artificial heart may be by an expansion device, but is not limited to a balloon on a balloon catheter. Expandable frames and / or artificial heart valves can be configured to crimp to diameters less than 24FR (e.g., less than 8mm, 5-7.9mm, etc.), and expandable frames and / or artificial heart valves can be configured to expand to diameters of at least 14mm (e.g., 14-35mm, and all values ​​and ranges in between), but it can be understood that expandable frames and / or artificial heart valves can be designed to crimp to larger diameters and / or expand to larger diameters.

[0054] According to another and / or alternative non-limiting aspect of the present disclosure, the expandable frame of an artificial heart valve is formed of a plurality of angularly spaced angular joint members and vertically extending axial longitudinal members. The angular joint members and vertically extending axial longitudinal members are interconnected to form various patterns (e.g., zigzag patterns, sawtooth patterns, triangular patterns, polygonal patterns, oval patterns, etc.). One or more of the angular joint members and / or vertically extending axial longitudinal members may have the same or different thicknesses and / or cross-sectional shapes and / or cross-sectional areas.

[0055] According to another and / or alternative non-limiting aspect of the present disclosure, an artificial heart valve comprises a) an expandable frame which is balloon-inflatable, mechanically expandable, or self-expanding, and b) at least one leaflet (e.g., 1 to 6 leaflets, as well as all values ​​and ranges in between). One or more leaflets are supported by the expandable frame. The artificial heart valve may include an inner skirt and / or an outer skirt. The expandable frame has a plurality of frame cells arranged in rows or columns in a cylindrical shape with proximal and distal ends. The metal frame is formed of a metal alloy which is plastically and / or elastically deformable to allow the expandable frame to expand and compress (compress) into different geometric states.

[0056] According to another and / or alternative non-limiting aspect of the present disclosure, the frame has an open-cell configuration, and the cells of the expandable metal frame comprise axial longitudinal members and angular joint members, the angular joint members being connected to each other through articulation joints, and the axial longitudinal members are connected to the angular joint members through base joins. In one non-limiting embodiment, the expandable frame has a shortening of 20% or less, and typically a shortening of 5% or less, and the frame cells comprise at least two axial longitudinal members and at least two pairs of angular joint members, each pair of members comprising at least two angular joint members connected by articulation joints, and during expansion or compression of the expandable frame, the total longitudinal length of the frame cells does not exceed the height of the axial longitudinal members. In one non-limiting configuration, the expandable frame is formed of a plurality of non-shortened frame cells. In another non-limiting configuration, the angular joint members in all cells within a row and / or column of frame cells are of the same length. In another non-limiting configuration, the length of the angular joint member is measured from vertex to vertex of the joint defining the end of the angular joint member, and the sum of the lengths of the angular joint members is less than or equal to the sum of the lengths of the axial longitudinal members. In another non-limiting configuration, the geometry of the angular joint member has independent curves in its width through at least a portion of the length of the angular joint member. In another non-limiting embodiment, the complete frame does not shorten during the expansion and / or crimping of the expandable frame, even if one or more of the frame cells shorten during the expansion and / or crimping of the expandable frame. In another non-limiting configuration, the longitudinal length between the proximal end and the distal end of the expandable frame is substantially constant or constant during the change in the diameter of the expandable frame. In another non-limiting configuration, one or more longitudinal columns extend throughout the entire distance from the distal end to the proximal end of the expandable frame. In another non-limiting configuration, the expandable frame includes at least one axial longitudinal member extending from the distal end of the frame to the proximal end of the frame, with a commissure attachment region located between the proximal and distal ends of the expandable frame.In another non-limiting configuration, the longitudinal distance from the commissar mounting area to the proximal end of the frame is approximately constant during the expansion and / or crimping of the expandable frame. In another non-limiting configuration, rows and columns of frame cells in the expandable frame are made of frame cells of the same width or height as adjacent circumferential or axial cells. In another non-limiting configuration, the difference in the cross-sectional area of ​​the window area of ​​one or more frame cells in the expandable frame does not differ by more than 20% when compared to other cells in the same column of frame cells and / or in the same row of expandable frame cells. In another non-limiting configuration, the expandable frame is made of an even or odd number of cells per row. In another non-limiting configuration, the expandable frame contains an odd number of cells. In another non-limiting configuration, one or more or all rows of cells in the expandable frame are formed of nine cells. In another non-limiting configuration, only the distal rows are constructed from an odd number of frame cells, and the other rows are formed from an even number of frame cells. In another, less restrictive configuration, the artificial heart valve is inserted into the heart such that, when the expandable frame is expanded, one or more of the frame cells are partially or completely positioned across the coronary arteries.

[0057] According to other and / or alternative non-limiting embodiments of this disclosure, the material used to form the expandable metal frame contains little to no nickel. Nickel and cobalt are alloys commonly used in the frames of commercially available artificial heart valves, despite the fact that such materials yield suboptimal results with respect to biocompatibility. In one non-limiting embodiment, the metal alloy used to form the expandable frame contains only trace amounts (e.g., less than 0.1 wt%) of cobalt and / or nickel. In another non-limiting configuration, the metal alloy used to form the expandable frame contains no nickel and / or cobalt at all. In another non-limiting configuration, the metal alloy used to form the expandable frame contains rhenium and, optionally, chromium and / or molybdenum. In another non-limiting configuration, the metal alloy used to form the expandable frame contains up to 70 wt% rhenium and one or more metals selected from the group consisting of Mo, Cr, Co, Ni, Ti, Ta, Nb, Zr, and / or W.

[0058] According to another and / or alternative non-limiting aspect of this disclosure, the material used to form an expandable metal frame has a high yield strength to give the expandable frame radial strength. In one non-limiting embodiment, the material used to form an expandable metal frame has a yield strength of at least 110 ksi. In one non-limiting embodiment, the material used to form an expandable metal frame has an elongation of at least 20%. In one non-limiting embodiment, the material used to form an expandable metal frame has a yield strength of at least 110 ksi and an elongation of at least 20%. In one non-limiting embodiment, the material used to form an expandable metal frame has a yield strength of at least 110 ksi and / or an elongation of at least 20% when the expandable frame is in its finished state (for example, finished state is defined as the material properties after undergoing any material processing such as heating, annealing, cold working, in-manufacturing, hot working, etc. Finished state means a material that is sterilized, or implanted, or ready to be shipped to a customer in the form of a medical device). In one non-limiting embodiment, the material used to form an expandable metal frame has low rebound and limits damage to tissue or conduction during implantation. In another non-limiting embodiment, the material used to form an expandable metal frame has an elastic modulus of at least 52,000 ksi and / or rebound of 5% or less when the frame is plastically deformed (e.g., expanded from a compressed state to an expanded state, compressed, etc.) and no further expansion force is applied to the expanded frame (e.g., the delivery balloon deflates and no load is applied to the expanded frame).

[0059] According to other and / or alternative non-limiting embodiments of this disclosure, the expandable frame may include distinctive features that enable rotational alignment between the expandable frame and the commissure of the innate heart valve. In one non-limiting embodiment, one or more distinctive features relating to the expandable heart valve are asymmetrical to identify the rotational alignment of the expandable frame. In another non-limiting embodiment, one or more distinctive features are directly attached to the commissure of the artificial heart valve frame. In another non-limiting embodiment, one or more distinctive features may be formed from a radiopaque material that enables high visibility during the procedure of inserting the artificial heart valve into the heart. In another non-limiting embodiment, one or more distinctive features may be at least partially fabricated from a material having a density of at least 10 mg / cm³. One or more distinctive features may be formed from the same or different material as the body of the frame.

[0060] According to other and / or alternative non-limiting embodiments of the present disclosure, the expandable frame of the artificial heart valve may optionally be coated with a polymer material (e.g., silicone, PTFE, ePTFE, polyurethane, polyolefin, hydrogel, biological material (e.g., pericardium, or biological polymers such as collagen, gelatin, or hyaluronic acid derivatives)). The coating may be used to partially or completely enclose the angular joint members and / or the vertically extending axial longitudinal members on the frame, and / or to fill the openings between the angular joint members and / or the vertically extending axial longitudinal members on the frame.

[0061] According to other and / or alternative non-limiting embodiments of the present disclosure, an artificial heart valve is provided, optionally comprising an inner skirt which can be formed from a variety of flexible materials (e.g., polymers [e.g., polyethylene terephthalate (PET), polyester, nylon, Kevlar®, silicon, etc.], composite materials, metals, textile materials, etc.). In one non-limiting embodiment, the material used to partially or completely form the inner skirt may optionally be substantially inelastic (i.e., substantially non-stretchable and incompressible). In another non-limiting embodiment, the material used to partially or completely form the inner skirt may optionally be stretchable and / or compressible (e.g., silicone, PTFE, ePTFE, polyurethane, polyolefin, hydrogel, biological materials [e.g., pericardium, or biological polymers such as collagen, gelatin, or hyaluronic acid derivatives], etc.). The inner skirt may optionally be formed from a combination of cloth or woven material coated with a flexible material or an elastic and / or compressible material to provide additional structural integrity to the inner skirt. The size, composition, and thickness of the inner skirt are not limiting (e.g., thickness from 0.1 to 20 mils, and all values ​​and ranges in between). The inner skirt may be fixed to the inside and / or outside of the frame by various means (e.g., sutures, clamp placement, etc.). In another non-limiting embodiment, the inner skirt may be made from woven fabric, but nonwoven fabric may also be used, or alternatively. In another non-limiting embodiment, the inner skirt (if used) may be used to 1) at least partially seal and / or prevent perivalve leakage, 2) at least partially fix the leaflet structure to the frame, 3) at least partially protect the leaflet from damage during the crimping and / or expansion process, and / or 4) at least partially protect the leaflet from damage during the operation of the artificial heart valve in the heart.

[0062] According to another and / or alternative non-limiting aspect of the present disclosure, an artificial heart valve is provided which optionally includes an outer or sleeve positioned at least partially around the external region of the frame. The outer skirt or sleeve is generally positioned entirely around a portion of the outer frame. Generally, the outer skirt is positioned around the lower portion of the frame but does not completely cover the upper half of the frame. However, this is not mandatory. The outer skirt can be attached to the frame by various arrangements (e.g., sutures, adhesives, fusion joints, clamp arrangements, etc.). At least a portion of the outer skirt can optionally be positioned on the inner surface of the frame. Generally, the outer skirt is formed of a material that is more flexible and / or compressible than the inner skirt, but this is not mandatory. The outer skirt can be formed of various stretchable and / or compressible materials (e.g., silicone, PTFE, ePTFE, polyurethane, polyolefin, hydrogel, biological materials [e.g., pericardium, or biological polymers such as collagen, gelatin, or hyaluronic acid derivatives], etc.). The outer skirt may optionally be formed from a combination of cloth or woven material coated with an elastic and / or compressible material to provide further structural integrity to the outer skirt. In another non-limiting embodiment, the outer skirt may be made from woven fabric, but nonwoven fabric may also be used, either further or alternatively. The size, composition, and thickness of the outer skirt are non-limiting. The thickness of the outer skirt is generally 0.1 to 20 mils (and all values ​​and ranges in between).

[0063] According to another and / or alternative non-limiting aspect of this disclosure, an artificial heart valve includes a leaflet structure that can be attached to a frame and / or skirt. The connection arrangements used to secure the leaflet structure to the frame and / or skirt are non-limiting (e.g., sutures, fusion bonding, adhesives, clamp arrangements, etc.). The materials used to form the leaflet structure include polymers, bovine pericardial tissue, bovine tissue, porcine tissue, biocompatible synthetic materials, or a variety of other suitable natural or synthetic materials. The tissues used to form one or more leaflets may optionally be treated / stabilized through a collagen crosslinking method and then stored in a dry or wet state (e.g., storing the tissue in a dry state after a glycerin-based dehydration process, etc.). In one non-limiting embodiment, the leaflet structure consists of two or more leaflets (e.g., two, three, four, five, six, etc.). In one non-limiting arrangement, the leaflet structure includes three leaflets arranged to fold in a tricuspid valve arrangement. The configuration of the leaflet structure is non-limiting. In another non-limiting embodiment, the leaflets of the leaflet structure may optionally be fixed to each other at their adjacent sides to form a cross joint (edges where the leaflets meet) of the leaflet structure. The leaflet structure may be fixed together by various connection arrangements (e.g., sutures, adhesives, fusion bonding, clamp arrangements, etc.). In another non-limiting embodiment, one or more of the leaflets may optionally include reinforcing structures or strips to 1) facilitate fixing the leaflets together, 2) facilitate fixing the leaflets to the skirt and / or frame, and / or 3) suppress or prevent tearing or other types of damage to the leaflets.

[0064] According to another and / or alternative, non-limiting aspect of the present disclosure, an artificial heart valve is provided that is configured to be inserted into a desired location in the body (e.g., the aortic valve, tricuspid valve, pulmonary valve, or mitral valve). The frame of the artificial heart valve can be formed at least partially of a plastically expandable material that allows for crimping of the frame into a smaller profile for delivery and expansion of the artificial heart valve into a larger profile. Expansion of the crimped frame may optionally be by the use of an expansion device, but is not limited to a balloon on a balloon catheter.

[0065] According to another and / or alternative non-limiting aspect of this disclosure, the use of a metal alloy to partially or completely form the frame of an artificial heart valve can be used to increase the strength and / or hardness and / or durability of the artificial heart valve frame compared to stainless steel or chromium-cobalt alloy or titanium alloy, and thus a smaller amount of metal alloy can be used in the artificial heart valve frame to achieve similar strength compared to an artificial heart valve frame formed of a different metal. Thus, the resulting artificial heart valve can be made smaller and less bulky by using a metal alloy without sacrificing the strength and durability of the artificial heart valve. Such an artificial heart valve can have a smaller profile and therefore can be inserted into smaller areas, openings, and / or passages. The metal alloy can also increase the radial strength of the artificial heart valve frame. For example, the thickness of the angular joint members and / or the axially longitudinal members extending vertically of the artificial heart valve frame, as well as the wires used at least partially to form the artificial heart valve frame, can be made thinner and achieve similar or improved radial strength compared to artificial heart valve frames with thicker walls made of stainless steel, titanium alloy, or cobalt-chromium alloy. Metal alloys can also improve the stress-strain properties, bendability, and flexibility of the artificial heart valve frame, and thus increase the lifespan of the artificial heart valve. For example, the artificial heart valve can be used in areas where it is subjected to bending. Due to the improved physical properties of the artificial heart valve made of metal alloy, the artificial heart valve has improved resistance to breakage in such frequent bending environments. In addition or alternatively, the improved bendability and flexibility of the artificial heart valve frame due to the use of metal alloy can make it easier to insert the artificial heart valve into various areas of the body. Metal alloys can also reduce the degree of rebound of the artificial heart valve frame during compression and / or expansion. For example, artificial heart valves, by using metal alloys, better maintain their crimped shape and / or their expanded shape after expansion.Therefore, when the artificial heart valve is crimped and mounted onto the delivery device, the artificial heart valve better maintains its smaller profile during insertion into various areas of the body. Furthermore, the artificial heart valve better maintains its expanded profile after expansion, facilitating success in the treatment area of ​​the artificial heart valve. In addition to the improved physical properties of the artificial heart valve due to the use of metal alloys, metal alloys can optionally improve radiopaque properties compared to standard materials such as stainless steel or cobalt-chromium alloys, thus reducing or eliminating the need for marker materials in the artificial heart valve.

[0066] According to other and / or alternative non-limiting aspects of this disclosure, the use of a metal alloy to form all or part of an artificial heart valve can offer several advantages over artificial heart valves formed from other materials. These advantages include, but are not limited to, the following: The metal alloy used partially or entirely to form the frame of the artificial heart valve may optionally have increased strength and / or hardness compared to stainless steel, chromium-cobalt alloy, or titanium alloy, and therefore less metal alloy can be used in the artificial heart valve to achieve similar strength compared to artificial heart valves formed from different metals. Thus, the resulting artificial heart valve can be made smaller and less bulky by using the metal alloy without sacrificing the strength and durability of the artificial heart valve. The artificial heart valve may also have a smaller profile and therefore can be inserted into smaller areas, openings, and / or passages. Thinner angular joint members and / or vertically extending axial longitudinal members of the metal alloy forming the frame or other parts of the artificial heart valve may be used to form the frame or other parts of the artificial heart valve that have strength that would otherwise be required if the angular joint members and / or vertically extending axial longitudinal members or other structures were made of stainless steel, chromium-cobalt alloy, or titanium alloy. The increased strength of the metal alloy used in the frame of the artificial heart valve optionally results in increased radial strength of the artificial heart valve. For example, the wall thickness of the artificial heart valve can optionally be thinner compared to an artificial heart valve with a thicker wall made of stainless steel, cobalt and chromium alloy, or titanium alloy, while achieving similar or improved radial strength. The metal alloy used to partially or completely form the frame of the artificial heart valve, optionally, has a reduced rebound during compression and / or expansion of the artificial heart valve compared to stainless steel, chromium-cobalt alloy, or titanium alloy. Artificial heart valves formed from metal alloys maintain their compression shape better and / or their expanded shape better after expansion due to the use of the metal alloy. Therefore, when the artificial heart valve is mounted on the delivery device in a compressed state, the artificial heart valve maintains its smaller profile better during insertion of the artificial heart valve into the body passage. Also, the artificial heart valve maintains its expanded profile better after expansion to facilitate the success of the artificial heart valve in the therapeutic area. The use of metal alloys in the frame of artificial heart valves, as an optional choice, results in a better fit of the artificial heart valve to irregularly shaped body passages when expanded in the body passages, compared to artificial heart valves formed from stainless steel, chromium-cobalt alloy, or titanium alloy. The metal alloy used to partially or completely form the frame of the artificial heart valve may optionally have improved radiopaque properties compared to standard materials (e.g., stainless steel or cobalt-chromium alloy), thus reducing or eliminating the need for marker materials on the artificial heart valve. For example, the metal alloy is at least about 10-20% more radiopaque than stainless steel or cobalt-chromium alloy. The metal alloy used to partially or completely form the frame of the artificial heart valve may optionally have improved fatigue ductility when cold-worked compared to cold-worked stainless steel, chromium-cobalt alloy, or titanium alloy. ·A metal alloy used to partially or fully form the frame of a prosthetic heart valve optionally has improved durability compared to stainless steel, a chromium-cobalt alloy, or a titanium alloy. ·A metal alloy used to partially or fully form the frame of a prosthetic heart valve optionally has improved hydrophilicity compared to stainless steel, a chromium-cobalt alloy, or a titanium alloy. ·A metal alloy used to partially or fully form the frame of a prosthetic heart valve optionally has reduced ion release in a bodily passage compared to stainless steel, a chromium-cobalt alloy, or a titanium alloy. ·A metal alloy used to partially or fully form the frame of a prosthetic heart valve optionally causes less irritation to the body than stainless steel, a cobalt-chromium alloy, or a titanium alloy, and thus can reduce inflammation, accelerate healing, and increase the success rate of the prosthetic heart valve. When the prosthetic heart valve is expanded in the bodily passage, some minor damage may occur inside the passage. When the body begins to heal such minor damage, the body has fewer adverse reactions to the presence of the metal alloy compared to other metals such as stainless steel, cobalt-chromium alloys, or titanium alloys. ·A metal alloy used to partially or fully form the frame of a prosthetic heart valve optionally has lower magnetic susceptibility than a CoCr alloy, a TiAlV alloy, and / or stainless steel, thus resulting in a lower incidence of potential defects of the prosthetic heart valve or complications in the patient after implantation of the prosthetic heart valve when the patient is exposed to MRI or other devices that generate strong magnetic fields.

[0067] According to another and / or alternative non-limiting aspect of the present disclosure, the frame of the prosthetic heart valve has, without limitation, one or more of the following features. ·High radial strength. ·Small or low crimped profile. ·Reduced recoil when expanded and / or crimped. • There is little or no shortening when extended. • Smooth curvature at and along the vertices of the angle joint members. • Symmetrical design for restoring valve function and visualizing the frame. • Physical markers on the frame for cross-alignment. • Nine open-cell design. • Open cells aligned with the coronary arteries for hemodynamic and re-intervention.

[0068] According to another and / or alternative non-limiting aspect of the present disclosure, an artificial heart valve includes a radially foldable and expandable frame and a leaflet structure comprising a plurality of leaflets. The artificial heart valve may optionally include an annular skirt member, which can be positioned between the frame and the leaflet structure. Each side of a leaflet can be fixed to an adjacent leaflet. The leaflets are connected to the frame of the artificial heart valve.

[0069] According to another and / or alternative non-limiting aspect of the present disclosure, an artificial heart valve includes a radially foldable and expandable frame comprising a plurality of angular joint members, a plurality of axial longitudinal members, and optionally one or more frame opening arrangements, wherein the angular joint members, the plurality of axial longitudinal members, and optionally one or more frame opening arrangements are connected to each other to form a plurality of cells within the frame. In one non-limiting arrangement, the expandable frame comprises an angular joint member having first and second ends, and the plurality of angular joint members having first and second ends connected to axial longitudinal members and / or frame opening arrangements. A combination of an angular joint member and an axial longitudinal member, or a combination of an angular joint member, an axial longitudinal member, and a frame opening arrangement, is used to form each of the cells within the frame. In one non-restrictive configuration, a frame can be formed by two or more sets of cells, each set containing the same number of cells, each set of cells optionally having the same number of cells, and each set of cells optionally having cells of the same shape and size that are present in one or more of the other sets of cells. In one non-restrictive configuration, a frame can be formed by three sets of cells, each set containing six to nine cells. As can be understood, a frame can contain two to ten sets of cells (and all values ​​and ranges in between), and each set of cells can contain two to sixteen cells (and all values ​​and ranges in between). In one non-restrictive configuration, the number, shape, and size of cells in each of the three sets of cells are mirror images of each other and have the same shape and size.

[0070] According to another and / or alternative non-limiting aspect of the present disclosure, an artificial heart valve includes a radially foldable and expandable frame, which includes one or more frame opening arrangements located at the top of the frame. Each of the frame opening arrangements may include a lower frame opening and an optional upper frame opening.

[0071] According to another and / or alternative non-limiting aspect of the present disclosure, the artificial heart valve includes a radially foldable and expandable frame comprising a plurality of axial longitudinal members. In one non-limiting embodiment, one or more of the axial longitudinal members extend 80–100% (and all values ​​and ranges in between) of the longitudinal length of the frame. In one non-limiting configuration, at least 50% (e.g., 50–100%, and all values ​​and ranges in between) of the axial longitudinal members extend 80–100% of the longitudinal length of the frame. In another non-limiting configuration, 10–45% (and all values ​​and ranges in between) of the axial longitudinal members of the frame extend less than 80% (e.g., 30–79%, and all values ​​and ranges in between) of the longitudinal length of the frame. In another non-limiting configuration, 20–40% of the axial longitudinal members of the frame extend less than 80% of the frame's longitudinal length. In another non-limiting embodiment, when the frame is plastically deformed (e.g., expanded from a crimped position to an expanded position), the axial longitudinal members are configured to limit or eliminate shortening of the frame. If the frame includes multiple axial longitudinal members having a longitudinal length of 80–100% of the frame's longitudinal length and spaced apart at various locations around the periphery of the frame, it facilitates suppressing or preventing shortening of the frame when the axial longitudinal members expand. In one non-limiting configuration, a) the longitudinal lengths of two or more axial longitudinal members are 90-100% of the longitudinal length of the frame, and / or b) one or more axial longitudinal members connected to the frame opening arrangement have a combined longitudinal length of 90-100% of the longitudinal length of the frame, and the axial longitudinal member configurations of a) and / or b) facilitate suppressing or preventing shortening of the frame when extended.

[0072] According to another and / or alternative non-limiting aspect of the present disclosure, the artificial heart valve includes a radially foldable and expandable frame, optionally comprising a plurality of axially longitudinal members formed from a plurality of axially longitudinal member segments. One or more axially longitudinal members may be formed from a single piece of material or from a plurality of pieces of material connected to one another (e.g., soldered, welded, glued, mechanically connected, etc.). The number of axially longitudinal member segments used to form each of the axially longitudinal members is non-limiting. In one non-limiting arrangement, the axially longitudinal member is formed from two to three axially longitudinal member segments. In one non-limiting embodiment, one or more or all of the axially longitudinal members are formed from a plurality of axially longitudinal member segments. In another non-limiting embodiment, one or more of the axially longitudinal members are formed from a single strut segment, and one or more of the axially longitudinal members are formed from a plurality of axially longitudinal member segments. In one non-limiting configuration, the frame includes one or more axial longitudinal members formed for a single strut segment and one or more axial longitudinal members formed by multiple axial longitudinal member segments, with a greater number of axial longitudinal members (e.g., 55–90%, and all values ​​and ranges in between) being formed by multiple axial longitudinal member segments. In another non-limiting embodiment, the axial longitudinal member segments forming each of the axial longitudinal members are generally aligned along the longitudinal axis of the axial longitudinal member. In yet another non-limiting embodiment, the thickness, width, and / or cross-sectional area of ​​the axial longitudinal member along the longitudinal axis of the axial longitudinal member can be constant or varied. In one non-limiting configuration, the thickness, width, and / or cross-sectional area of ​​each of the axial longitudinal members along the longitudinal axis of the axial longitudinal member varies.In another non-limiting configuration, one or more axial longitudinal member segments located closer to the top of the frame have a thickness, width, and / or cross-sectional area less than the thickness, width, and / or cross-sectional area of ​​one or more axial longitudinal member segments located below the axial longitudinal member segments located closer to the top of the frame. In another non-limiting embodiment, if an axial longitudinal member is formed of two or more axial longitudinal member segments, the longitudinal lengths of the axial longitudinal member segments may be the same or different. In one non-limiting configuration, an axial longitudinal member formed of two or more axial longitudinal member segments has two or more axial longitudinal member segments with different longitudinal lengths.

[0073] According to another and / or alternative non-limiting aspect of the present disclosure, the artificial heart valve includes a radially foldable and expandable frame comprising a plurality of angular joint members. In one non-limiting embodiment, the frame comprises at least two rows of angular joint members (e.g., 2 to 12, and all values ​​and ranges in between). In another non-limiting embodiment, multiple, most or all, or all, of the shapes, sizes, and / or configurations of the angular joint members on each row of the angular joint members are the same. In one non-limiting configuration, all shapes, sizes, and configurations of the angular joint members on one or more rows of the angular joint members are the same. In another non-limiting configuration, some shapes, sizes, and configurations of the angular joint members on a row of the angular joint members differ from those of other angular joint members on the same row of the angular joint members.

[0074] According to another and / or alternative non-limiting aspect of the present disclosure, the artificial heart valve comprises a radially foldable and expandable frame including a plurality of angular joint members, wherein a plurality, most, or all of the angular joint members are formed by a centrally located arcuate or semicircular portion, and first and second arms extending from each side of the semicircular portion. In one non-limiting embodiment, each of the first and second arms includes one or more wavy portions. In another non-limiting embodiment, the longitudinal length of one or both arms is greater than the width of the semicircular portion. In another non-limiting configuration, the combined longitudinal length of the two arms constitutes at least 60% (e.g., 60–95%, and all values ​​and ranges in between) of the total longitudinal length of the angular joint member. In another non-limiting embodiment, the plurality of angular joint members have first and second arms of the same length, size, shape, and / or configuration. In one non-limiting configuration, multiple angle joint members have first and second arms that are the same length, size, shape, and configuration. In another non-limiting configuration, when the frame is in an extended orientation, the semicircular portion has an arc length of 60–190° (and all values ​​and ranges in between), and when the frame is in a crimped or folded orientation, the semicircular portion has an arc length of 80–340° (and all values ​​and ranges in between).

[0075] According to another and / or alternative non-limiting aspect of the present disclosure, the artificial heart valve includes a radially foldable and expandable frame comprising three or more rows of angular joint members, wherein the gaps between the rows of angular joint members positioned adjacent to the angular joint members may be the same or different.

[0076] According to another and / or alternative non-limiting aspect of the present disclosure, the artificial heart valve includes a radially foldable and expandable frame, which includes one or more frame opening arrangements that can be used to fix in place one or more leaflet structures, leaflets, inner skirts, and / or outer skirts. In one non-limiting embodiment, one or more of the frame opening arrangements include a first frame opening and, optionally, a second frame opening. The size and shape of the lower frame opening and the optionally upper frame opening are non-limiting. In one non-limiting configuration, one or more optionally upper frame openings can be used as markers to facilitate proper positioning of the frame and the artificial heart valve in the heart.

[0077] According to another and / or alternative non-limiting aspect of the present disclosure, the artificial heart valve includes a radially foldable and expandable frame having one or more of the following features: a) high radial strength after expansion of the frame, b) small compression profile, c) use of material that minimizes material rebound after expansion of the frame, d) little or no shortening of the frame during expansion, e) smooth curvature at and along the vertices of the angular joint members and / or axial longitudinal members of the frame, f) symmetrical design for restoration of valve function and visualization of the frame, g) markers on the frame for commissure alignment, and / or h) open cells aligned with the coronary arteries for hemodynamic and re-intervention.

[0078] One non-limiting object of this disclosure is to provide a heat-resistant metal alloy, or a metal alloy containing at least 5 awt.% (e.g., 5 to 99 awt.%, and all values ​​and ranges in between) that can be used in part or in whole to form the frame of an artificial heart valve.

[0079] Another and / or alternative non-limiting object of this disclosure is to provide an artificial heart valve comprising a frame partially or completely formed of a heat-resistant metal alloy or a metal alloy containing at least 5 awt.% (e.g., 5 to 99 awt.%, and all values ​​and ranges in between) rhenium, the artificial heart valve having an improved procedural success rate.

[0080] Another and / or alternative non-limiting object of this disclosure is to provide an artificial heart valve including a frame, which, by novel geometric shapes combined with a frame partially or completely formed of a rhenium-containing alloy, enables the formation of a frame such as:a) Having an open-cell geometric shape within the frame of the artificial heart valve, which can be used to reduce the size of the delivery system and reduce vascular and neurological complications; b) Having high radial strength using the open-cell pattern due to the high yield strength and maximum tensile strength of the rhenium-containing metal alloy; c) Having improved recovery of physiological EOA in severely calcified valves that are difficult to force large forces on the bioprosthetic valve, while allowing a reduced compression diameter for vascular access; d) Having improved recovery of physiological EOA, which results in a longer service life of the bioprosthetic valve; e) Having less rebound of the frame when expanded by including materials that have lower rebound than conventional materials such as stainless steel, chromium-cobalt, or titanium alloy, which leads to a reduced risk of valve embolism, reduced paravalvular leakage due to improved fit to the innate anatomical structure, more accurate recovery of physiological EOA, and reduced conduction system damage due to a smaller balloon inflation diameter required to obtain physiological EOA after balloon inflation; f) Open g) The cellular geometry enables a frame geometry without any shortening, and as a frame without any shortening has a shorter initial frame length that allows for a shorter balloon, thus enabling more precise placement of the valve in the innate annulus, thereby reducing conduction system damage; h) It has commissure alignment markers and open cells between commissures that enable proper placement of the bioprosthetic valve relative to the innate commissures of the valve for proper hemodynamic function regarding washout from the valve and blood flow to the coronary arteries, which leads to higher durability and longer service life of the valve, as well as coronary artery access and re-intervention that prevents future adverse events; i) It has a radially symmetric, longitudinally symmetric, and completely unshortened open-cell geometry that enables symmetrical and cylindrical expansion of the prosthetic valve, resulting in a reduction in the incidence of Leaflet thrombosis and structural valve degradation; and i) It is formed from a nickel-free rhenium-containing metal alloy, preventing allergic reactions due to the presence of nickel and restenosis associated with nickel content.

[0081] Another and / or alternative non-limiting object of the present disclosure is to provide an artificial heart valve for implantation in the heart, the artificial heart valve comprising an expandable metal frame, a leaflet structure supported by the expandable metal frame, and an inner skirt fixed to the expandable metal frame, wherein the expandable metal frame is configured to expand from a crimp orientation to an expand orientation when the artificial heart valve is positioned at a treatment site in the heart, the expandable metal frame comprising a plurality of angular articulated members and a plurality of axial longitudinal members, the angular articulated members and the axial longitudinal members being connected to each other to form a plurality of cells arranged in rows in the expandable metal frame, wherein the rows of cells are connected by the axial longitudinal members, and when the expandable metal frame is in the expand orientation, one or more of the axial longitudinal members have a longitudinal length that is at least 10% of the longitudinal length of the expandable metal frame.

[0082] Another and / or alternative non-limiting object of the present disclosure is to provide an artificial heart valve for implantation in the heart, the leaflet structure comprising a plurality of leaflets, each leaflet having an upper edge portion, a lower edge portion, and two lateral flaps, each lateral flap being connected to an adjacent lateral flap of another leaflet, and at least a portion of the leaflet structure being connected to an expandable metal frame.

[0083] Another and / or alternative non-limiting object of this disclosure is to provide an artificial heart valve for implantation in the heart, wherein the leaflet structure is attached to an expandable metal frame using multiple sutures, staples, or adhesives.

[0084] Another and / or alternative non-limiting object of the present disclosure is to provide an artificial heart valve for implantation in the heart, comprising an expandable metal frame and at least one leaflet connected to the expandable metal frame, wherein the expandable metal frame is configured to be crimped and to further expand from a crimped orientation to an expanded orientation at an opening of a body passage, the expandable metal frame having a distal end and a proximal end, and the expandable metal frame having a) an open cell configuration comprising a plurality of frame cells, the open cell configuration being formed of a material having high radial strength, b) reduced rebound, so that when expanded, the frame has reduced rebound, and c) can be crimped to a small diameter The expandable metal frame has the following characteristics: i) at least 70-100% of the expandable metal frame is formed of a metal alloy having a yield strength of at least 110 ksi; ii) at least 70-100% of the expandable metal frame is formed of a metal alloy having an elastic modulus of at least 35000 ksi; iii) a frame geometry having a maximum of 9 frame cells per horizontal row; iv) at least 70-100% of the expandable metal frame is formed of a rhenium-containing metal alloy containing at least 0.1 wt% rhenium and one or more metals selected from the group consisting of Mo, Cr, Co, Ni, Ti, Ta, Nb, Zr, and W; v) at least 70-100% of the expandable metal frame is at least 0.formed of a rhenium-containing metal alloy comprising 1 wt% rhenium and one or more metals selected from the group consisting of Mo, Cr, Co, Ni, Ti, Ta, Nb, Zr, and W, wherein the metal alloy is partially or completely formed from metal powders sintered together, having two or more of: vi) when the expandable metal frame is plastically deformed, the expandable metal frame has a shortening of 20% or less; vii) each of the cells comprises at least one axial longitudinal member and at least two angled joint members, each of the angled joint members comprising a plurality of arcuate portions along the longitudinal length of the angled joint member; viii) each of the cells comprises at least one axial longitudinal member and at least two angled joint members, each of the angled joint members comprising a plurality of arcuate portions along the longitudinal length of the angled joint member, wherein one or more of the axial longitudinal members have a continuous linear shape of at least 80% of the longitudinal length of the axial longitudinal member; and / or ix) the outer surface of the expandable frame comprises a reinforcing coating.

[0085] Another and / or alternative non-limiting object of the present disclosure is to provide a prosthetic heart valve for implantation in a heart, wherein one or more of the frame cells comprises at least two axial longitudinal members and at least two pairs of angled joint members, each of the pairs of angled joint members comprising at least two angled joint members connected by a articulation joint, at least one of the axial longitudinal members extending from the distal end to the proximal end of the expandable frame, and during expansion and / or crimping of the expandable frame, the full longitudinal length of the frame, the frame cell does not exceed the longitudinal length of the axial longitudinal member.

[0086] Another and / or alternative non-limiting object of the present disclosure is to provide an artificial heart valve comprising an expandable metal frame and at least one leaflet connected to the expandable metal frame, wherein the expandable metal frame is configured to be crimped and to further expand in a body passage from a crimped orientation to an expansion orientation opening, the expandable metal frame having a distal end and a proximal end, and the expandable metal frame comprises a) an open cell configuration comprising a plurality of frame cells and at least two rows of frame cells, and / or b) being formed of a material having less than 6% rebound when expanded from a crimped orientation to an expansion orientation, and thus resulting in reduced rebound of the expandable metal frame, wherein the expandable metal frame has the following properties: i) at least 70-100% of the expandable metal frame is formed of a metal alloy having a yield strength of at least 110 ksi, ii) at least 70-100% of the expandable metal frame is formed of a metal alloy having an elastic modulus of at least 35000 ksi, iii) up to nine per horizontal row iv) A frame geometric shape having frame cells, at least 70-100% of the expandable metal frame is formed of a metal alloy made of a rhenium-containing metal alloy, comprising at least 0.1 wt% rhenium and one or more metals selected from the group consisting of Mo, Cr, Co, Ni, Ti, Ta, Nb, Zr, and W, v) The expandable metal frame is formed of a material having a rebound of 5% or less when the expandable metal frame is plastically deformed, vi) When the expandable metal frame is plastically deformed, the expandable metal vii) an expandable metal frame having a shortening of 20% or less, and / or viiii) each cell having at least one axial longitudinal member and at least two angular joint members, each angular joint member having a plurality of arcuate portions along the longitudinal length of the angular joint member, and one or more of the axial longitudinal members having a continuous linear shape for at least 80% of the longitudinal length of the axial longitudinal member.

[0087] Another and / or alternative non-limiting object of the present disclosure is to provide an artificial heart valve in which one or more frame cells include at least two axial longitudinal members and at least two angular articulated members, each of which angular articulated members includes a first arm and a second arm connected to an articulated joint, the articulated joint having an arcuate or semicircular portion, and each of the axial longitudinal members having a continuous linear shape for at least 90% of the longitudinal length of the axial longitudinal member.

[0088] Another and / or alternative non-limiting object of the present disclosure is to provide an artificial heart valve in which at least one axial longitudinal member in a row of frame cells is aligned along the same longitudinal axis to form a group of aligned axial longitudinal members, the group of aligned axial longitudinal members extending entirely from the distal end to the proximal end of an expandable metal frame, and during expansion and / or compression of the expandable metal frame, the total longitudinal length of each frame cell in a row of frame cells does not exceed the total longitudinal length of each axial longitudinal member in the frame cell.

[0089] Another and / or alternative non-limiting object of this disclosure is to provide an artificial heart valve in which one or more of the angular joint members include one or more independent radii over their longitudinal length.

[0090] Another and / or alternative non-limiting object of this disclosure is to provide an artificial heart valve in which the sum of the longitudinal lengths of the angular joint members is equal to or greater than the sum of the longitudinal lengths of the axial longitudinal members.

[0091] Another and / or alternative non-limiting object of the present disclosure is to provide an artificial heart valve in which the longitudinal length of an expandable frame is equal to the longitudinal length of at least one of a group of aligned axial longitudinal members during expansion and compression of the expandable frame.

[0092] Another and / or alternative non-limiting object of the present disclosure is to provide an artificial heart valve in which the longitudinal length between the proximal end of the expandable frame and the commissure attachment area on the expandable frame is constant during expansion and / or crimping of the expandable frame.

[0093] Another and / or alternative non-limiting object of the present disclosure is to provide an artificial heart valve further comprising a commissure alignment marker positioned within an expandable frame, wherein the commissure alignment marker is formed of the same material used to form the expandable frame.

[0094] Another and / or alternative non-limiting object of this disclosure is to provide an artificial heart valve in which angular joint members within a frame cell in the same column and / or same row of the frame cell have the same longitudinal length.

[0095] Another and / or alternative non-limiting object of the present disclosure is to provide an artificial heart valve in which the vertices of adjacently positioned frame cells within adjacent rows are aligned within 5% of the total angular length of the angular joint member.

[0096] Another and / or alternative non-limiting object of this disclosure is to provide an artificial heart valve in which each region of the most distal row of the frame cells on an expandable frame and each region of the nearest end of the frame cells are not more than 20% different.

[0097] Another and / or alternative non-limiting object of this disclosure is to provide an artificial heart valve in which the material of the expandable frame is at least partially made from a metal alloy containing less than 1 wt% nickel and / or less than 0.1 wt% cobalt.

[0098] Another and / or alternative non-limiting object of the present disclosure is to provide an artificial heart valve in which an expandable metal frame comprises a plurality of angular joint members and a plurality of axial longitudinal members, the angular joint members and the axial longitudinal members being connected to one another to form a plurality of cells of the expandable metal frame arranged in rows, each cell comprising at least one axial longitudinal member and at least two angular joint members, each angular joint member comprising a plurality of arcuate portions along the longitudinal length of the angular joint member, one or more of the axial longitudinal members having a continuous linear shape for at least 80% of the longitudinal length of the axial longitudinal member, and the expandable metal frame having a shortening of 20% or less when the expandable metal frame is plastically deformed.

[0099] Another and / or alternative non-limiting object of the present disclosure is to provide an artificial heart valve in which, when the expandable metal frame is in an expanded orientation, one or more of the axial longitudinal members have a longitudinal length that is 70 to 100% of the longitudinal length of the expandable metal frame.

[0100] Another and / or alternative non-limiting object of the present disclosure is to provide an artificial heart valve comprising an expandable metal frame including a first strut row, a second strut row, and a third strut row, each of the first, second, and third strut rows including a plurality of angle joint members, each of the angle joint members in the first strut row including a first end and a second end, the first end of each angle joint member being connected to one of the axial longitudinal members, each of the second end of each angle joint member being connected to a different axial longitudinal member, each of the angle joint members in the second strut row including a first end and a second end, and the plurality or all first ends of the plurality or all of the angle joint members being connected to one of the axial longitudinal members , multiple or all second ends of multiple or all angle joint members are connected to longitudinal members in different axial directions, each of the angle joint members in the third strut row includes a first end and a second end, multiple or all first ends of multiple or all angle joint members are connected to one of the longitudinal members in the axial direction, multiple or all second ends of multiple or all angle joint members are connected to longitudinal members in different axial directions, when the expandable metal frame is in the expanded orientation, all angle joint members in the first strut row are separated from the angle joint members of the second and third strut rows, and when the expandable metal frame is in the expanded orientation, all angle joint members in the second strut row are separated from the angle joint members of the third strut row.

[0101] Another and / or alternative non-limiting object of the present disclosure is to provide an artificial heart valve comprising an expandable metal frame comprising a fourth strut row, the fourth strut row comprising a plurality of angular joint members, each of the angular joint members in the first strut row comprising a first end, a second end, and each of the plurality or all first ends of each angular joint member being connected to one of the axial longitudinal members, and each of the plurality or all second ends of each angular joint member being connected to different axial longitudinal members, wherein when the expandable metal frame is in an expanded orientation, all the angular joint members in the fourth strut row are separated from the angular joint members in the first, second, and third strut rows.

[0102] Another and / or alternative non-limiting object of the present disclosure is to provide an artificial heart valve comprising a plurality of axial longitudinal members, comprising a first axial longitudinal member segment and a second axial longitudinal member segment, wherein the first and second axial longitudinal member segments have different longitudinal lengths, and each of the first and second axial longitudinal member segments comprises a top end and a bottom end, wherein the top end of each of the first axial longitudinal member segments is connected to a) the bottom end of the second axial longitudinal member segment and b) two of the angular joint members, and the top end of the second end of each of the second axial longitudinal member segments is connected to the bottom portion of two of the angular joint members and / or one of the frame opening arrangements.

[0103] Another and / or alternative non-limiting object of the present disclosure is to provide an artificial heart valve comprising a plurality of axial longitudinal members, each comprising a third axial longitudinal member segment, wherein the longitudinal length of the third axial longitudinal member segment is different from the longitudinal length of the first and / or second axial longitudinal member segments, and the third axial longitudinal member segment comprises a apex, a bottom, and each bottom of the third axial longitudinal member segment is connected to two of the following: a) the apex of a second axial longitudinal member segment and / or b) an angular joint member, and the apex of each third end of the second axial longitudinal member segment is connected to two of the angular joint members.

[0104] Another and / or alternative non-limiting object of the present disclosure is to provide an artificial heart valve, each of which an angular joint member includes a centrally located arcuate portion and first and second arms extending from each side of the arcuate portion, wherein the first arm on each of the angular joint members has a first arm end, and the second arm on each of the angular joint members has a second arm end, and each of the first arm ends is connected to a) one of one of a set of axial longitudinal members and / or b) one of a frame opening arrangement, wherein the longitudinal length of one or both of the first and second arms on each of the angular joint members is greater than the width or longitudinal length of the semicircular portion.

[0105] Another and / or alternative non-limiting object of this disclosure is to provide an artificial heart valve, each of which a first arm and a second arm comprises one to three wavy portions.

[0106] Another and / or alternative non-limiting object of this disclosure is to provide an artificial heart valve in which an expandable metal frame is partially or completely formed of a heat-resistant metal alloy or a metal alloy containing at least 15 awt.% rhenium, or a heat-resistant metal alloy or a metal alloy containing at least 5 awt.% rhenium, wherein the metal alloy is not a shape memory alloy.

[0107] Another and / or alternative non-limiting object of the present disclosure is to provide an artificial heart valve in which an expandable metal frame is formed of a material having reduced rebound when bent such that when the expandable metal frame is crimped into a crimped state the expandable frame has a rebound of 5% or less; b) the expandable metal frame is formed of a material having reduced rebound when bent such that when the expandable frame is expanded from a crimped state to an expanded state the expandable frame has a rebound of 5% or less; and / or c) the expandable metal frame has a shortening ratio of less than 20% when expanded from a crimped state.

[0108] Another and / or alternative non-limiting object of the present disclosure is to provide an expandable artificial heart valve comprising an expandable metal frame for implantation in a body passage, wherein the expandable metal frame is configured to be crimped and expanded from a crimped orientation to an expanded orientation at an opening in the body passage, the expandable metal frame having a distal end and a proximal end, the expandable metal frame comprising a plurality of frame cells and at least two rows of frame cells, and the expandable metal frame having the following characteristics: i) at least 70-100% of the expandable metal frame is less ii) The expandable metal frame is formed of a metal alloy having a yield strength of 110 ksi, at least 70-100% of the expandable metal frame is formed of a metal alloy having an elastic modulus of at least 35,000 ksi, iii) The frame geometry has a maximum of 9 frame cells per horizontal row, iv) At least 70-100% of the expandable metal frame is formed of a rhenium-containing metal alloy containing at least 0.1 wt% rhenium and one or more metals selected from the group consisting of Mo, Cr, Co, Ni, Ti, Ta, Nb, Zr, and W, v) Expandable vi) when the expandable metal frame is plastically deformed, the expandable metal frame has a shortening of 20% or less, vii) each cell includes at least one axial longitudinal member and at least two angular joint members, and the angular joint viiii) Each joint member includes a plurality of arc-shaped portions along the longitudinal length of the angle joint member, each cell includes at least one axial longitudinal member and at least two angle joint members, each angle joint member includes a plurality of arc-shaped portions along the longitudinal length of the angle joint member, one or more of the axial longitudinal members have a continuous linear shape for at least 80% of the longitudinal length of the axial longitudinal member, and / or ix) the outer surface of the expandable frame includes two or more of the following, each angle joint member includes,Optionally, the angle joint member includes multiple arc-shaped portions along its longitudinal length, and one or more of the axial longitudinal members optionally have a continuous linear shape for at least 80% of the longitudinal length of the axial longitudinal member, and one or more of the frame cells optionally include at least two axial longitudinal members and at least two angle joint members, each of the angle joint members optionally includes a first arm and a second arm connected to the joint joint, and the joint joint has an arc-shaped or semicircular portion, each of the axial longitudinal members However, the axial longitudinal members have a continuous linear shape for at least 90% of their longitudinal length, and at least one axial longitudinal member in a row of frame cells is optionally aligned along the same longitudinal axis to form a group of aligned axial longitudinal members, and this group of aligned axial longitudinal members extends completely from the distal end to the proximal end of the expandable metal frame, and during expansion and / or crimping of the expandable metal frame, the entire longitudinal length of each frame cell in a row of frame cells is optionally aligned with the axial longitudinal members in the frame cell The longitudinal length of each member is not exceeded, and one or more of the angular joint members optionally include one or more independent radii over their longitudinal lengths, the sum of the longitudinal lengths of the angular joint members is greater than or equal to the sum of the longitudinal lengths of the axial longitudinal members, the longitudinal length of the expandable frame optionally equals the longitudinal length of at least one of the aligned axial longitudinal members during expansion and crimping of the expandable frame, and the longitudinal length between the proximal end of the expandable frame and the commissar mounting area on the expandable frame expands The expandable frame is constant during tension and / or compression, and optionally further includes commissure alignment markers positioned within the expandable frame, the commissure alignment markers being formed of the same material used to form the expandable frame, the material used to form the commissure alignment markers being optionally a metal having a density greater than 10 mg / cm3, the commissure alignment markers being optionally mounted in a commissure mounting area, and the distal row of frame cells on the expandable frame optionally containing an odd number of frame cells.Angular joint members within a frame cell in the same row and / or column of a frame cell have the same longitudinal length, and the vertices of adjacently positioned frame cells in adjacent rows are optionally aligned within 5% of the total longitudinal length of the angle joint member, and each region of the farthest row of a frame cell on an expandable frame and each region of the nearest end of a frame cell are optionally different by more than 20%, and the material of the expandable frame is optionally made from a metal alloy containing less than 1% by weight of nickel and / or less than 0.1% by weight of cobalt, and the expandable frame is optionally made from a heat-resistant metal alloy, The frame is formed of a metal alloy containing at least 5 awt.% or 1 awt% rhenium (e.g., 5 to 99 awt.% rhenium, and all values ​​and ranges in between), and the frame optionally includes a reinforcing coating, and the expandable metal frame is optionally partially or completely formed of a rhenium-containing metal alloy containing at least 0.1 wt% rhenium and one or more metals selected from the group consisting of Mo, Cr, Co, Ni, Ti, Ta, Nb, Zr, and W, and the metal alloy is partially or completely formed from metal powders sintered together.

[0109] These and other advantages will become apparent to those skilled in the art upon reading and following this description.

[0110] Non-limiting and non-exclusive embodiments are described with reference to the following drawings, and similar symbols refer to similar parts throughout the various drawings unless otherwise specified. The size and relative position of elements in the drawings are not necessarily drawn to scale. For example, the shapes of various elements are selected, enlarged, and positioned to improve the readability of the drawings. Certain shapes of the drawn elements are selected for ease of recognition in the drawings. With reference thereto, the drawings illustrate various embodiments that this disclosure may take in physical form as well as in certain parts and arrangements of parts. [Brief explanation of the drawing]

[0111] [Figure 1A] This disclosure provides an example of TAV. [Figure 1B] It is a part of a catheter from prior art. [Figure 1C] This paper illustrates a typical TAVR procedure for inserting a transcatheter aortic valve (TAV) into a heart valve. [Figure 1D] This paper illustrates a typical TAVR procedure for inserting a transcatheter aortic valve (TAV) into a heart valve. [Figure 1E] This paper illustrates a typical TAVR procedure for inserting a transcatheter aortic valve (TAV) into a heart valve. [Figure 2] Figure 1A illustrates the characteristics of the longitudinal members in the axial direction and the angular joint members of the frame, as shown in the example of the TAV. [Figure 3] This is a front view of the TAV frame in its extended state according to the present disclosure. [Figure 4] This is a front view of the flat frame of the TAV in its extended state, as disclosed herein. [Figure 5] This is a front view of the flat frame of the TAV in a crimped or unexpanded state according to the present disclosure. [Figure 6A] This is a front view of another flat frame of the TAV in its extended state, as disclosed herein. [Figure 6B] This is a front view of the flat frame in the extended state of Figure 6A, including non-limiting frame dimensions. [Figure 6C] This section illustrates various features and structures of the TAV frame. [Figure 6D] This section illustrates various features and structures of the TAV frame. [Figure 6E] This section illustrates various features and structures of the TAV frame. [Figure 7] This table lists the yield strength and elastic modulus of various metal alloys for comparison. [Figure 8] This graft compares the radial strength of frames made from standard CoCr alloy and frames made from MoRe alloy. [Figure 9] This graph illustrates the recoil rates of several different metal alloys. [Figure 10]This example compares the suitability of metal strips or wires made of heat-resistant metal to the shape of a die surface, and also compares this to the suitability of metal strips or wires made of CoCr alloy on the same die surface. [Figure 11] Figures A and B illustrate the fit of a TAV frame made of a heat-resistant metal alloy, expanded within a non-circular aortic valve containing calcium deposits, compared to a TAV frame of similar shape and configuration made of a CoCr alloy, also expanded within the same non-circular aortic valve. The figures illustrate that the increased fit of the heat-resistant metal alloy frame compared to the CoCr alloy frame results in greater paravalvular leakage (PVL) around the TAV with the CoCr alloy frame than around the TAV with the heat-resistant metal alloy frame. [Figure 12] Figures A through C illustrate the stress-to-reduction ratio in the percentage area graphs of TiAlV alloy, CoCr alloy, and MoRe alloy. [Figure 13] This graph illustrates the differences in stiffness and yield strength between MoRe alloy, CoCr alloy, and TiAlV alloy. [Figure 14A] This graph illustrates the strength and fatigue ductility of TiAlV alloy, CoCr alloy, and MoRe alloy. [Figure 14B] This graph illustrates the strength and fatigue ductility of TiAlV alloy, CoCr alloy, and MoRe alloy. [Figure 14C] This graph illustrates the strength and fatigue ductility of TiAlV alloy, CoCr alloy, and MoRe alloy. [Figure 15] The hydrophilicity of MoRe alloys, CoCr alloys, and TiAlV alloys is illustrated with examples. [Modes for carrying out the invention]

[0112] A more complete understanding of the articles / devices, processes, and components disclosed herein can be obtained by referring to the accompanying drawings. These drawings are merely schematic diagrams based on convenience and ease of demonstration of the disclosure, and are therefore not intended to show the relative sizes and dimensions of the devices or their components, and / or to define or limit the scope of the exemplary embodiments.

[0113] For clarity, specific terminology is used in the following description, but these terms are intended to refer only to specific structures of embodiments selected for illustration in the drawings, and are not intended to define or limit the scope of this disclosure. In the drawings and the following description, similar numerical designations refer to components of similar function.

[0114] The singular forms "a," "an," and "the" refer to multiple objects unless explicitly indicated otherwise in the context.

[0115] As used herein and in the claims, the term “comprising” may include embodiments of “consisting of” and “consisting essentially of.” The terms “comprise(s),” “include(s),” “having,” “has,” “can,” and “contain(s)” as used herein, and their variations, are intended to be open-ended transitional phrases, terms, or words that require the presence of a specified component / step and permit the presence of other components / steps. However, such descriptions should also be interpreted as describing a composition or process as “consisting of” and “essentially of” the enumerated components / steps, which permits the presence of only the specified component / step and excludes other components / steps, along with any unavoidable impurities that may arise therefrom.

[0116] The numerical values ​​in the specification and claims of this application should be understood to include numerical values ​​that are the same when reduced to the same number of significant figures and numerical values, but which are different from numerical values ​​that are smaller than the experimental error of the conventional measurement techniques of the type described in this application for determining the value.

[0117] All ranges disclosed herein include the enumerated endpoints and are independently combinable (for example, the range “2 grams to 10 grams” includes the endpoints, 2 grams and 10 grams, as well as all intermediate values).

[0118] The terms "approximately" and "about" can be used to include any number that can change without altering the fundamental function of its value. When used with a range, "approximately" and "about" also disclose a range defined by the absolute values ​​of two endpoints; for example, "approximately 2 to approximately 4" also discloses a range of "2 to 4". In general, the terms "approximately" and "about" can refer to plus or minus 10% of the indicated number.

[0119] Unless otherwise explicitly stated, the percentage of an element should be assumed to be the weight percentage of the element as stated.

[0120] While the operations of exemplary embodiments of the disclosed methods may be described in a specific sequential order for convenient presentation, it should be understood that the disclosed embodiments may encompass orders of operations other than the specific sequential order disclosed. For example, operations described sequentially may, in some cases, be rearranged or performed simultaneously. Furthermore, the descriptions and disclosures provided in relation to one particular embodiment are not limited to that embodiment and may apply to any disclosed embodiments.

[0121] For the sake of simplification, the accompanying diagrams may not show the various ways in which the disclosed systems, methods, and apparatus can be used in combination with other systems, methods, and apparatus (which are readily identifiable to those skilled in the art based on this disclosure). Additionally, the description may use terms such as “generate” and “provide” to describe the disclosed methods. These terms are abstractions of the actual operations that can be performed. The actual operations corresponding to these terms may vary depending on the specific implementation and are readily identifiable to those skilled in the art based on this disclosure.

[0122] Referring here to Figures 1A to 1E, these figures illustrate an implantable artificial heart valve 100 (e.g., a TAV) and a method for inserting the artificial heart valve 100 into a valve region A of the heart H (e.g., the aortic valve). The artificial heart valve 100 can be implanted within the annulus of the natural aortic valve A, but the artificial heart valve 100 can also be configured to be implanted within other valves of the heart. The medical device illustrated is a TAV, but this disclosure is not limited to a TAV or any other heart valve replacement.

[0123] Referring here to Figure 1A, the artificial heart valve 100 generally comprises a frame 110 formed of a plurality of axial longitudinal members and angular joint members 112, 114, a strut joint 113, a leaflet structure 200 supported by the frame 110, and an inner skirt 300 fixed to the outer surface of the frame 110 and / or the leaflet structure 200. The frame may include one or more orientation structures 116. The frame 110 is partially or completely formed of a rhenium-containing metal alloy. The artificial heart valve 100 has a "lower" end 120 and an "upper" end 130, where the lower end 120 is the inlet end and the upper end 130 is the outlet end.

[0124] The frame 110 may optionally be coated with a polymer material (e.g., silicone, PTFE, ePTFE, polyurethane, polyolefin, hydrogel, biological material [e.g., pericardium, or biological polymer [e.g., collagen, gelatin, or hyaluronic acid derivatives])). The coating can be used to partially or completely enclose one or more of the vertically extending axial longitudinal members 112 and / or non-vertically angled joint members 114 on the frame 110, and / or to partially or completely fill one or more of the openings between the non-vertically angled joint members 114 and / or the vertically extending axial longitudinal members 112.

[0125] The inner skirt 300 can be formed from a variety of flexible materials (e.g., polymers (e.g., polyethylene terephthalate (PET), polyester, nylon, Kevlar, silicon, etc.), composite materials, metals, textile materials, etc.). In one non-limiting embodiment, the material used to partially or completely form the inner skirt 300 may be substantially inelastic (i.e., substantially non-stretchable and incompressible). In another non-limiting embodiment, the material used to partially or completely form the inner skirt 300 may be a stretchable and / or compressible material (e.g., silicone, PTFE, ePTFE, polyurethane, polyolefin, hydrogel, biological material [e.g.]). For example, it may be the pericardium, or a biological polymer such as collagen, gelatin, or a hyaluronic acid derivative. The inner skirt 300 may optionally be formed from a combination of cloth or woven material coated with a flexible material or an elastic and / or compressible material to provide additional structural integrity to the inner skirt 300. The size, composition, and thickness of the inner skirt 300 are not limiting (e.g., thickness from 0.1 to 20 mils, as well as all values ​​and ranges in between). The inner skirt 300 may be fixed to the inside and / or outside of the frame 110 using various means (e.g., sutures, clips, clamp arrangements, etc.).

[0126] The inner skirt 300 can be used to: 1) at least partially seal and / or prevent valve-peripheral leakage; 2) at least partially secure the leaflet structure 200 to the frame 110; 3) at least partially protect one or more leaflets of the leaflet structure 200 from damage during the crimping process of the artificial heart valve 100; and 4) at least partially protect one or more leaflets of the leaflet structure 200 from damage during the operation of the artificial heart valve 100 within the heart H.

[0127] The artificial heart valve 100 may optionally include an outer skirt or sleeve (not shown) positioned at least partially around the external region of the frame 110. The outer skirt or sleeve (if used) is generally positioned entirely around a portion of the outside of the frame 110. Generally, the outer skirt is positioned around the lower portion of the frame 110 and does not completely cover the upper portion of the frame 110, but this is not required. The outer skirt can be attached to the frame 110 by various arrangements (e.g., sutures, adhesive, fusion joints, clamp arrangements, etc.). At least a portion of the outer skirt may optionally be positioned on the inner surface of the frame 110, but this is not required. Generally, the outer skirt is formed of a material that is more flexible and / or compressible than the inner skirt 300, but this is not required. The outer skirt can be formed from a variety of stretchable and / or compressible materials (e.g., silicone, PTFE, ePTFE, polyurethane, polyolefin, hydrogel, biological materials [e.g., pericardium, or biological polymers such as collagen, gelatin, or hyaluronic acid derivatives]). Optionally, the outer skirt can be formed from a combination of cloth or woven materials coated with a stretchable and / or compressible material to provide further structural integrity to the outer skirt. The size, composition, and thickness of the outer skirt are not limited. The thickness of the outer skirt is generally 0.1 to 20 mils (and all values ​​and ranges in between).

[0128] The leaflet structure 200 can be attached to the frame 110 and / or the inner skirt 300. The connection arrangements used to secure the leaflet structure 200 to the frame 110 and / or the inner skirt 300 (e.g., sutures, fused adhesive, glue, clamp arrangements, etc.) are not limited. Materials used to form one or more leaflets of the leaflet structure 200 include, but are not limited to, bovine pericardial tissue, biocompatible synthetic materials, or a variety of other suitable natural or synthetic materials.

[0129] The leaflet structure 200 can consist of two or more leaflets (e.g., two, three, four, five, six, etc.). In one non-limiting arrangement, the leaflet structure 200 includes three leaflets arranged to fold in a tricuspid valve arrangement. The size, shape, and configuration of one or more leaflets in the leaflet structure 200 are non-limiting. In one non-limiting arrangement, the leaflets have generally the same shape, size, configuration, and thickness.

[0130] Two or more leaflets of the leaflet structure 200 can be optionally fixed to each other at their adjacent sides to form a cross joint (edge ​​where the leaflets meet) of the leaflet structure 200. The leaflet structure 200 can be fixed to the frame 110 and / or inner skirt 300 by various connection arrangements (e.g., sutures, adhesives, molten bond, clamp arrangements, etc.).

[0131] One or more leaflets of the leaflet structure 200 may optionally include reinforcing structures or strips to 1) facilitate securing the leaflets together, 2) facilitate securing the leaflets to the inner skirt 300 and / or frame 110, and / or 3) suppress or prevent tearing or other types of damage to the leaflets.

[0132] The artificial heart valve 100 is configured to be radially foldable in a folded or crimped state for delivery into the body on a delivery catheter (Figure 1B), and radially expandable in an expanded state for implantation of the artificial heart valve 100 at a desired location within the heart H (e.g., the aortic valve A) (Figure 1E). The frame of the artificial heart valve 100 is made of a plastically expandable material (e.g., a heat-resistant metal alloy) that allows the frame to be crimped to a smaller profile for delivery and expansion of the artificial heart valve 100 using an expansion device. Figure 1B illustrates a typical frame F of an artificial heart valve crimped on a typical balloon catheter C. The frame F can be expanded from a crimped state to an expanded state using a balloon B on the balloon catheter C. Various types of crimping devices and techniques can be used to crimp the artificial heart valve onto a balloon delivery catheter. The process of crimping an artificial heart valve using a crimping device is known in the art and will not be described herein. During the crimping procedure, damage to the leaflet structure should be avoided.

[0133] As illustrated in Figures 1C to 1E, once the artificial heart valve 100 is compressed onto the balloon B of the balloon catheter C, the balloon catheter C is inserted through a blood vessel into the location within the heart H where the artificial heart valve 100 will be deployed (see Figure 1C). At the treatment site, the balloon B on the balloon catheter C is expanded, thereby expanding the artificial heart valve 100 and fixing it within the valve region A of the heart H (see Figure 1D). Subsequently, the balloon B is deflated, and the balloon catheter C is removed from the patient (see Figure 1E).

[0134] Referring here to Figures 3 to 6E, a novel frame 400 for the artificial heart valve 100 is illustrated. The frame 400 is configured to be crimped onto a delivery catheter C so that the crimped artificial heart valve 100 can be inserted into a heart valve. The frame 400 can optionally be configured to allow the artificial heart valve 100 to be crimped to a diameter of less than 22 Fr, but this is not required. Thus, the artificial heart valve 100 including the frame 400 according to this disclosure can optionally be configured to allow the artificial heart valve 100 to be inserted into smaller heart valves that could not be treated with prior art artificial heart valves. As can be understood, the artificial heart valve 100 according to this disclosure can be sized and configured to be inserted into heart valves greater than 22 Fr.

[0135] Referring here to Figures 3 to 5, one non-limiting embodiment of the frame 400 according to the present disclosure is illustrated. Figures 6A to 6E illustrate another non-limiting embodiment of the frame 400 according to the present disclosure. As will be discussed in more detail below, the frame 400 illustrated in Figures 3 to 5 includes four rows of angle joint members 410 and a set of cells including nine cells 480, and the frame 400 illustrated in Figures 6A to 6E includes three rows of angle joint members 410 and a set of cells including six cells 480.

[0136] Referring again to Figures 3 to 5, the radially foldable and expandable frame 400 includes a plurality of angular joint members 410, a plurality of axial longitudinal members 450, and a plurality of frame opening arrangements 460, the angular joint members 410, the plurality of axial longitudinal members 450, and the frame opening arrangements 460 being connected to each other to form a plurality of cells 480 within the frame 400. The angular joint members 410 have first ends 412 and second ends 414 connected to the axial longitudinal members 450 or the frame opening arrangements 460.

[0137] The frame opening arrangement 460 is located at the top of the frame 400. Each of the frame opening arrangements 460 may include a lower frame opening 462 and, optionally, upper frame openings 464, 466.

[0138] As illustrated in Figure 4, frame 400 is formed of three sets of cells, each set of cells containing nine cells 480. As illustrated in Figures 6A and 6B, frame contains two sets of cells, each set of cells containing nine cells. As illustrated in Figure 4, the number, shape, and size of cells 480 in each of the three sets of cells are mirror images of each other and have the same shape and size.

[0139] Referring again to Figures 3 to 5, the multiple axial longitudinal members 450 are formed by three axial longitudinal member segments 452, 454, and 456, and some of the axial longitudinal members 450 are formed by two axial longitudinal member segments. The frame 400 illustrated in Figures 6A to 6E includes multiple axial longitudinal members or axial longitudinal members, some of which are formed by two axial longitudinal member segments, and some of which are formed by a single axial longitudinal member segment. The axial longitudinal members 450 can be formed from a single piece of material, or from multiple pieces of material connected to each other (e.g., soldered, welded, glued, mechanically connected, etc.). The axial longitudinal member segments forming each axial longitudinal member 450 are generally aligned along the longitudinal axis of the axial longitudinal member 450. The thickness or cross-sectional area of ​​each axial longitudinal member 450 along each longitudinal axis of the axial longitudinal member can be constant or modified. The lower axial longitudinal member segment 452 can have a greater thickness or cross-sectional area than the upper axial longitudinal member segment 456. The intermediate axial longitudinal member segment 454 can have a greater thickness or cross-sectional area than the upper axial longitudinal member segment 456. The lower axial longitudinal member segment 452 can have approximately the same thickness or cross-sectional area as the intermediate axial longitudinal member segment 454. As can be understood, the lower axial longitudinal member segment 452 can have a different thickness or cross-sectional area than the intermediate axial longitudinal member segment 454. The cross-sectional shape of each axial longitudinal member 450 along the longitudinal length of the axial longitudinal member 450 can be constant or modified. The longitudinal lengths of the axial longitudinal member segments may be the same or different.The longitudinal member segment 452 in the lower axial direction may have a longitudinal length less than the longitudinal length of either or both of the longitudinal member segments 454 in the intermediate axial direction and the longitudinal member segment 456 in the upper axial direction, while the longitudinal member segment 454 in the intermediate axial direction may have a longitudinal length greater than either or both of the longitudinal member segments 452 in the lower axial direction and the longitudinal member segment 456 in the upper axial direction. As illustrated in Figure 4, the longitudinal member segment 452 in the lower axial direction has the shortest longitudinal length, and the longitudinal member segment 454 in the intermediate axial direction has the longest longitudinal length.

[0140] As illustrated in Figures 3 and 4, the frame 400 includes a first row 420 of angle joint members 410, a second row 422 of angle joint members 410, a third row 424 of angle joint members 410, and a fourth row 426 of angle joint members 410. The first row 420 of angle joint members 410 is the bottom row, and the fourth row 426 of angle joint members 410 is the top row. The shape, size, and / or configuration of the angle joint members 410 in the first row 420 are the same. The shape, size, and / or configuration of the angle joint members 410 on the second row 422 are the same. The shape, size, and / or configuration of the angle joint members 410 on the third row 424 are the same. The shape, size, and / or configuration of the multiple angle joint members 410 on the fourth row 426 are the same, while the multiple angle joint members 410 on the fourth row 436 are different. Referring again to Figure 4, the angle joint member 410 on the fourth row 426, where either the first end 412 or the second end 414 of the angle joint member 410 is connected to the frame opening arrangement 460, has a different shape, size, and / or configuration from the angle joint member 410 on the fourth row 426, where both the first end 412 and the second end 414 of the angle joint member 410 are connected to the axial longitudinal member 450.

[0141] Referring again to Figures 3 to 6E, each of the angular joint members 410 is formed by a centrally located arc-shaped or semicircular portion 430, with the first arm 432 and the second arm 434 extending from each side of the semicircular portion 430. The first arm 432 terminates at a first end 412, and the second arm 434 terminates at a second end 414. Each of the first arm 432 and the second arm 434 includes one or more wavy portions 440, 442. As illustrated in Figure 4, the first arm 432 includes a first wavy portion 440 and a second wavy portion 442, with the first wavy portion 440 located closer to the semicircular portion 430 than the second wavy portion 442. Furthermore, the second arm 434 includes a first wavy portion 440 and a second wavy portion 442, the first wavy portion 440 being located closer to the semicircular portion 430 than the second wavy portion 442. Thus, each angle joint member 410 includes at least three wavy portions along its longitudinal length. As illustrated in Figure 4, each angle joint member 410 includes five wavy portions along its longitudinal length.

[0142] As best illustrated in Figure 4, all first arms 432 and second arms 434 of the angle joint member 410 include two wavy sections. However, the shape and size of two or more wavy sections in a row of the angle joint member 410 may differ, but this is not mandatory. As also illustrated in Figure 4, the shape and size of the wavy sections, as well as their location on the angle joint member 410 in each row of the angle joint member 410, are generally the same. As also illustrated in Figure 4, the shape and size of the wavy sections, as well as their location on the angle joint member 410 in the first row 420 and the second row 422, are the same or very similar (e.g., the dimensional difference is less than 5%). As also illustrated in Figure 4, the shape and size of the wavy sections on the angle joint member 410 in the third row differ from those in the first row 420, the second row 422, and the fourth row 426. Furthermore, the shape and size of the wavy portion on the angle joint member 410 on the fourth row differ from those of the first row 420, the second row 422, and the third row 424. In another non-limiting embodiment, for multiple angle joint members 410, the length, shape, and / or size of the first arm 432 and the second arm 434 are the same or very similar (e.g., the dimensional difference is less than 5%). In one non-limiting configuration, the angle joint member 410 forming the first row 420 of the angle joint member 410 has a first arm 432 and a second arm 434, and the length, shape, and size of the first arm 432 and the second arm 434 are the same. In another non-limiting configuration, the angle joint member 410 forming the second row 422 of the angle joint member 410 has a first arm 432 and a second arm 434, wherein the length, shape, and size of the first arm 432 and the second arm 434 are the same. In another non-limiting configuration, the angle joint member 410 forming the third row 424 of the angle joint member 410 has a first arm 432 and a second arm 434, wherein the length, shape, and size of the first arm 432 and the second arm 434 are the same. In another non-limiting configuration, the angle joint member 410 forming the fourth row 424 of the angle joint member 410 has a first arm 432 and a second arm 434, wherein the length and shape of the first arm 432 and the second arm 434 are not all the same.In another non-limiting configuration, the angular joint members 410 of the first row 420 and the second row 422 have a first arm 432 and a second arm 434, wherein the length, shape, and size of the first arm 432 and the second arm 434 are the same as or very similar (e.g., the dimensional difference is less than 5%) for the angular joint members 410 of the first row 420 and the second row 422. In another non-limiting configuration, the angular joint members 410 on the first row 420, the second row 422, the third row 424, and the fourth row 426 a) have the same width, and / or b) the midpoint of the semicircular portion 430 is located midway between adjacently positioned axial longitudinal members 450, within ±5% (and all values ​​and ranges in between).

[0143] Referring again to Figures 3 to 6E, the gaps in the angular joint member 410 between rows 420, 422, 424, and 426 positioned adjacent to the angular joint member 410 may be the same or different. In one non-limiting embodiment, the gaps in the angular joint member 410 between adjacent rows (e.g., the first and second rows, the second and third rows, the third and fourth rows, etc.) may be different. As illustrated in Figure 4, the gap between the semicircular portions 430 of the first row 420 and the second row 422 of the angle joint member 410 is larger than the gap between the semicircular portions 430 of the second row 422 and the third row 424 of the angle joint member 410, the gap between the first ends 412 of the first row 420 and the second row 422 of the angle joint member 410 is smaller than the gap between the first ends 412 of the second row 422 and the third row 424 of the angle joint member 410, and the gap between the second ends 414 of the first row 420 and the second row 422 of the angle joint member 410 is smaller than the gap between the second ends 414 of the second row 422 and the third row 424 of the angle joint member 410. As illustrated in Figure 4, the semicircular portions 430 of the first row 420 and the second row 422 of the angle joint member 410 are oriented toward the top of the frame, while the semicircular portions 430 of the third row 424 and the fourth row 425 of the angle joint member 410 are oriented toward the bottom of the frame. Therefore, the semicircular portions 430 of the second row 422 and the third row 424 of the angle joint member 410 face each other. As illustrated in Figure 4, the gap between the semicircular portions 430 of the third row 424 and the fourth row 426 of the angle joint member 410 is larger than the gap between the semicircular portions 430 of the first row 420 and the second row 422 of the angle joint member 410, the gap between the first ends 412 of the third row 424 and the fourth row 426 of the angle joint member 410 is larger than the gap between the first ends 412 of the first row 420 and the second row 422 of the angle joint member 410, and the gap between the second ends 414 of the third row 424 and the fourth row 426 of the angle joint member 410 is larger than the gap between the second ends 414 of the first row 420 and the second row 422 of the angle joint member 410.As illustrated in Figure 4, the gap between the semicircular portions 430 of the third row 424 and the fourth row 426 of the angle joint member 410 is larger than the gap between the semicircular portions 430 of the second row 422 and the third row 424 of the angle joint member 410, the gap between the first ends 412 of the third row 424 and the fourth row 426 of the angle joint member 410 is smaller than the gap between the first ends 412 of the second row 422 and the third row 424 of the angle joint member 410, and the gap between the second ends 414 of the third row 424 and the fourth row 426 of the angle joint member 410 is smaller than the gap between the second ends 414 of the second row 422 and the third row 424 of the angle joint member 410.

[0144] As illustrated in Figures 6A to 6E, the gaps between angle joint members of adjacent rows may differ.

[0145] Referring here to Figures 3 to 6E, the frame opening arrangement 460 is located between the third row 424 and the fourth row 426 of the angular joint member 410. As can be understood, one or more frame opening arrangements 460 can be located in other areas of the frame 400. The frame opening arrangement 460 can optionally be used as a fixing location for one or more leaflet structures 200, but one or more of the frame opening arrangements 460 can optionally be used as a fixing location for other structures (e.g., leaflets, inner skirts, outer skirts, etc.), and / or can be used as an indicator of orientation and / or location of the frame 400 within a body passage or heart valve. Alternatively, an orientation structure 490 can be included in the frame 400. As illustrated in Figures 3 to 6E, each of the frame opening arrangements 460 includes a first frame opening strut 470 and a second frame opening strut 472, between these frame opening struts forming a lower frame opening 462 and, optionally, upper frame openings 464, 466. The size and shape of the lower frame opening 462 and the optional upper frame openings 464, 466 are non-limiting. As illustrated in Figures 3 and 4, the lower frame opening 462 has a generally rectangular shape and extends only partially along the longitudinal length of the frame opening arrangement 460. As can be understood, the lower frame opening 462 can have other shapes and sizes. In one non-limiting configuration, each of the frame opening arrangements 460 includes a lower frame opening 462, and all lower frame openings 462 have the same or very similar shape and size (e.g., dimensional difference is less than 5%). In one non-limiting embodiment, one or both of the first frame opening strut 470 and the second frame opening strut 472 have a longitudinal axis that is parallel to the longitudinal axis of the axial longitudinal member 450 to which the bottom of the frame opening arrangement 460 is connected, and / or b) a longitudinal axis that is offset from the longitudinal axis of the axial longitudinal member 450 to which the bottom of the frame opening arrangement 460 is connected.As illustrated in Figures 3 and 4, both the first frame opening strut 470 and the second frame opening strut 472 have a) a longitudinal axis parallel to the longitudinal axis of the axial longitudinal member 450 to which the bottom of the frame opening arrangement 460 is connected, and b) a longitudinal axis offset from the longitudinal axis of the axial longitudinal member 450 to which the bottom of the frame opening arrangement 460 is connected. The longitudinal length of one or both of the first frame opening strut 470 and the second frame opening strut 472 can be less than or equal to the longitudinal length of the axial longitudinal member segment located adjacent to the first frame opening strut 470 and the second frame opening strut 472. As illustrated in Figure 4, the longitudinal lengths of the first frame opening strut 470 and the second frame opening strut 472 are approximately equal to the longitudinal length of the axial longitudinal member segment 456.

[0146] As illustrated in Figure 4, the end of the first arm 432 or the second arm 434 of the angular joint member 410 of the fourth row 426 connected to the frame opening arrangement 460 can optionally be configured to be angled downward, and the other end of the first arm 432 or the second arm 434 of the angular joint member 410 connected to the axial longitudinal member segment can be configured to be angled upward. As illustrated in Figure 4, the ends of the first arm 432 and the second arm 434 of the angular joint member 410 of the first row 440, the second row 422, and the third row 424 connected to the axial longitudinal member segment are both angled in the same direction. As illustrated in Figure 4, when the frame is in the expanded orientation, the angle β of the angular joint member 410 with respect to the axial longitudinal member 450 is generally 25 to 60° (and all values ​​and ranges in between). Figures 6A to 6E illustrate similar arrangements for connecting angular joint members to axial longitudinal members or frame openings.

[0147] Referring here to Figures 3 and 4, the frame opening arrangement 460 may optionally include one or more optional upper frame openings 464, 466. One or more optional upper frame openings 464, 466 are generally positioned above the lower frame opening 462. Generally, one or more optional upper frame openings 464, 466 have a smaller cross-sectional area or size than the lower frame opening 462, but this is not required. As illustrated in Figures 3 and 4, two or more of the optional upper frame openings 464, 466 have different shapes. The different shapes of one or more optional upper frame openings 464, 466 can be used as markers to facilitate proper positioning of the frame 400 and the artificial heart valve 100 in the heart. In one particular non-limiting configuration, each of the one or more optional upper frame openings 464, 466 has a different shape. As illustrated in Figure 3, two of the frame opening arrangements 460 include upper frame openings 464 and 466 of two different shapes, while the other frame opening arrangement 460 does not include an upper frame opening. As illustrated in Figure 6, the frame 400 does not include an upper frame opening.

[0148] Each apex of the frame opening arrangement 460 may optionally include an apex marker 468. The shape and size of the apex marker 468 (if used) are not limited. As illustrated in Figures 3, 4, and 6, the shape and size of the markers 468 are the same or very similar (e.g., the dimensional difference is less than 5%). The apex marker 468 can be used as a marker to facilitate the proper positioning of the frame 400 and the artificial heart valve 100 in the heart. One or more apex markers 468 (if used) can also, or alternatively, be used to allow one or more components of the artificial heart valve 100 (e.g., leaflet, inner skirt, outer skirt, etc.) to be attached to the frame 400. The apex marker 468 can be formed of the same or different material as the other parts of the frame 400.

[0149] Non-limiting dimensions of the frame 400 formed of a metal alloy according to this disclosure, which can be extended up to 26 mm, include: a) an axial longitudinal member 450 having a length of 18 to 28 mm (and all values ​​and ranges in between); b) a length of the frame 400 in a flat state of generally 70 to 95 mm (and all values ​​and ranges in between); c) an axial longitudinal member 450 having a width generally in the range of 0.2 to 0.7 mm (and all values ​​and ranges in between); and d) a depth generally in the range of 0.2 to 0.7 mm (and all values ​​and ranges in between). Examples include: an axial longitudinal member 450 having; e) an angular joint member 410 having a width generally in the range of 0.2 to 0.7 mm (and all values ​​and ranges therein); f) an angular joint member 410 having a depth generally in the range of 0.2 to 0.7 mm (and all values ​​and ranges therein); g) a gap between adjacently positioned axial longitudinal members 450, generally 6 to 12 mm (and all values ​​and ranges therein); and h) the number of cells 480 in each set of cells can be 2 to 20 (and all values ​​and ranges therein). The width and / or depth of the lower axial longitudinal member can optionally be greater than one or more of the upper axial longitudinal members. Similarly, the width and / or depth of the angular joint member can optionally be greater than one or more of the upper angular joint members.

[0150] Figures 3 and 4 illustrate the frame 400 in the expanded position, and Figure 5 illustrates the frame 400 in the unexpanded or crimped position.

[0151] Frame 400 is partially or completely formed of a heat-resistant metal alloy, or a metal alloy containing at least 15 awt.% rhenium.

[0152] When the frame 110 of the artificial heart valve 100 is formed of a heat-resistant metal alloy or a metal alloy containing at least 15 awt.% rhenium, it can be crimped to have the following crimp outer diameters: a) at least 5% and up to 33% smaller than the crimp outer diameter of a frame of the same size, structure, and shape formed of a Co-Cr alloy (e.g., 5-33% and all values ​​and ranges in between); b) at least 5% and up to 40% smaller than the crimp outer diameter of a frame of the same size, structure, and shape formed of a Nitinol (e.g., 5-40% and all values ​​and ranges in between); and / or c) at least 5% and up to 40% smaller than the crimp outer diameter of a frame of the same size, structure, and shape formed of a TiAlV alloy (e.g., 5-40% and all values ​​and ranges in between).

[0153] Frames 400 of artificial heart devices (e.g., TAVRs) formed from heat-resistant metal alloys or metal alloys containing at least 15 awt.% rhenium have one or more improved properties or advantages compared to frames of artificial heart valves formed from stainless steel, Co-Cr alloys, TiAlV alloys, or NiTi alloys, namely, 1) the outer diameter (OD) of a crimped artificial valve having a frame formed from a heat-resistant metal alloy or metal alloy containing at least 15 awt.% rhenium is smaller than the crimped OD diameter of a crimped artificial valve having the same frame dimensions but being made from Co-Cr alloys, TiAlV alloys, or NiTi alloys, and 2) the width of strut joints on a frame formed from a heat-resistant metal alloy or metal alloy containing at least 15 awt.% rhenium (e.g., where the ends of angular joint members and / or axial longitudinal members connect to another part of the frame) can be smaller than the width of strut joints on a frame formed from stainless steel, Co-Cr alloys, TiAlV alloys, or NiTi alloys, but still, stainless steel, Co-Cr 4) The rebound of a frame made of a heat-resistant metal alloy or a metal alloy containing at least 15 awt.% rhenium after the frame is compressed or expanded is less than the rebound of a frame made of stainless steel, Co-Cr alloy, TiAlV alloy, or NiTi alloy having the same frame dimensions, and / or 4) the rebound of a frame made of a heat-resistant metal alloy or a metal alloy containing at least 15 awt.% rhenium after the frame is compressed or expanded is less than the rebound of a frame made of stainless steel, Co-Cr alloy, TiAlV alloy, or NiTi alloy having the same frame dimensions, and / or 4) the rebound of a frame made of a heat-resistant metal alloy or a metal alloy containing at least 15 awt.% rhenium after the frame is expanded is less than the rebound of a frame made of stainless steel, Co-Cr alloy, TiAlV alloy, or NiTi alloy having at least 15 awt.% rhenium after the frame is compressed or expanded.The shortening of a frame formed from a metal alloy containing % rhenium is less than that of a frame formed from stainless steel, Co-Cr alloy, TiAlV alloy, or NiTi alloy, having the same frame dimensions. In one non-limiting configuration, the metal alloy used to partially or completely form the frame is formed from sintered metal powders. Such sintered powdered metal alloys are different from cast metal alloys. In another non-limiting configuration, the metal alloy used to partially or completely form the frame is formed from sintered metal powders, and the metal alloy undergoes cold working to increase the ductility of the metal alloy.

[0154] The frame configurations illustrated in Figures 3 to 6E result in little to no shortening of the frame when it is expanded from a compressed state. Generally, the amount of shortening of the frame from a compressed state to an expanded state is 0–5%, more typically 0–20% (and all values ​​and ranges in between), typically 0–15%, and even more typically 0–10%. The orientation and configuration of the axial longitudinal member segments (e.g., 452, 454, 456) facilitate the reduction of shortening of the frame when it is expanded from a compressed state. Similarly, the orientation and configuration of the axial longitudinal member segments (e.g., 452, 454, 456) facilitate the reduction of shortening of the frame when it is compressed. The reduced shortening facilitates ensuring that the artificial heart implant maintains its proper position in the treatment area when the frame is expanded from a compressed state. A shortened artificial heart implant frame results in a reduction in the longitudinal length when the frame is expanded. Reducing the longitudinal length during such frame expansion can lead to misplacement of the expanded artificial heart implant in the therapeutic area, which can result in: a) improper operation of the implanted artificial heart implant, b) damage to the implanted artificial heart implant, c) potential damage to the tissues surrounding the implanted artificial heart implant, d) reduced lifespan of the artificial heart implant, and / or e) formation of plaque and / or calcium deposits around the artificial heart implant.

[0155] The strength of the heat-resistant metal alloy, or metal alloy containing at least 15 awt.% rhenium, used to partially or completely form frame 400 can, optionally, be higher than that of cobalt-chromium alloy, nickel-titanium alloy, or TiAlV alloy. Therefore, the width of the angular joint members and / or axial longitudinal members and / or strut joints of frame 400 can be smaller than that of frames formed from cobalt-chromium alloy, nickel-titanium alloy, or TiAlV alloy, thereby allowing for a smaller frame without sacrificing frame strength.

[0156] As illustrated in Table 1, illustrated in Figure 7, the yield strength and Young's modulus (or elastic modulus) of a MoRe alloy (e.g., 45-55 wt% Re and 45-55 wt% Mo) are compared with two CoCr alloys (e.g., MP35N and L605) and a stainless steel alloy (316L). As shown in Table 1, the yield strength of the MoRe alloy is at least twice that of the CoCr alloys such as MP35N and L605 and the stainless steel alloy such as 316L. Furthermore, the Young's modulus of the MoRe alloy is at least 1.5 times that of the CoCr alloys such as MP35N and L605 and the stainless steel alloy such as 316L. In one non-limiting embodiment, the metal alloy used to form 75% to 100% (and all values ​​and ranges in between) of the frame has a yield strength that is at least 1.1 times (e.g., 1.1 to 4 times, and all values ​​and ranges in between) that of standard CoCr alloy, MP35N alloy, L605 alloy, standard SS alloy, and stainless steel 316L alloy. In another non-limiting embodiment, the metal alloy used to form 75% to 100% (and all values ​​and ranges in between) of the frame (e.g., a heat-resistant metal alloy, a heat-resistant metal alloy containing at least 25 wt.% rhenium, or a metal alloy containing at least 15 awt.% rhenium) has a Young's modulus that is at least 1.1 times (e.g., 1.1 to 2.5 times, and all values ​​and ranges in between) that of standard CoCr alloy, MP35N alloy, L605 alloy, standard SS alloy, and stainless steel 316L alloy.

[0157] Referring to Figure 8, the graph provides a comparison of the radial forces of two frames of an artificial heart valve, which have the same size and configuration, one being a MiRus™ frame formed from MoRe alloy (e.g., 45-55 wt% Re and 45-55 wt% Mo), and the other being formed from standard MP35N alloy. As illustrated in Figure 8, for a frame extended to a diameter of 25.75 mm, the frame formed from MoRe alloy has greater radial strength than the frame formed from standard MP35N alloy. Therefore, the angular joint members and / or axial longitudinal members of the frame formed from MoRe alloy can be thinner than those of the frame formed from standard MP35N alloy, yet can still have the same or greater radial strength as the frame formed from standard MP35N alloy. Furthermore, the greater radial strength provided by the metal alloy allows for a larger open cell size in the frame compared to the prior art frame, and a smaller crimping profile compared to the prior art frame.

[0158] The rebound of materials used in frames made of heat-resistant metal alloys or metal alloys containing at least 15 awt.% rhenium when the frame is plastically deformed (e.g., crimped, expanded from a crimped state, etc.) can be less than that of frames of the same size and configuration made of cobalt-chromium alloys, nickel-titanium alloys, or TiAlV alloys. The rebound of materials used in frames made of heat-resistant metal alloys or metal alloys containing at least 15 awt.% rhenium when the frame is crimped or expanded from a crimped state is generally 8% or less (e.g., 0–8%, and all values ​​and ranges in between), typically 5% or less, more typically 3% or less, even more typically 2% or less, and even more typically less than 2%. Due to the low rebound, the frame may only require a single crimping cycle to obtain the smallest crimped outer diameter of the frame. Frames made of metal alloys with greater rebound typically require multiple crimping processes to obtain the designed sides of the crimped frame.

[0159] As illustrated in Figure 9, a) a frame formed from a Co-Cr alloy (e.g., 35Co-35Ni-20Cr-10Mo) rebounds by more than 9% (e.g., 9-15%, and all values ​​and ranges in between) after the radial compressive force is removed from the frame, or b) a frame formed from a titanium alloy (e.g., Ti-6Al-4V) rebounds by more than 6% (e.g., 6-10%, and all values ​​and ranges in between) after the radial compressive force is removed from the frame. Figure 9 illustrates that a frame morphology of a MoRe alloy (e.g., 45-55 wt% Re and 45-55 wt% Mo) rebounds by less than 2% (e.g., 0.1-1.99%, and all values ​​and ranges in between) after compression or expansion. Therefore, if the frame is formed from a metal alloy that reduces rebound, the need for the frame to undergo multiple crimping cycles or procedures can be eliminated, thereby reducing a) the incidence of damage to the frame, b) the incidence of damage to the leaflet of the prosthetic heart valve, c) the incidence of damage to the inner and / or outer skirt on the prosthetic heart valve, and / or d) the incidence of damage to other components of the prosthetic heart valve (e.g., damage to the balloon on the catheter, damage to one or more components on the catheter, etc.). Reduced rebound after expansion of frames formed from heat-resistant metal alloys or metal alloys containing at least 15 awt.% rhenium results in a better fit of the frame to the size of the orifice in the heart. Thus, the increased EOA (effective orifice area) results in a reduction of paravalvular leakage (i.e., leakage caused by the gap between the patient's natural cardiac tissue and the valve replacement). Greater rebound of frames formed from Co-Cr alloys or Ti alloys results in a reduction of EOA and an increase in paravalvular leakage around the prosthetic heart valve.

[0160] Figure 10 illustrates two different wires formed from heat-resistant metals such as CoCr and MoRe to illustrate the bending conformity of two types of wires. When the frame of an artificial heart implant is expanded, the angular joint members and / or axial longitudinal members of the frame undergo plastic deformation (e.g., generally outward deformation) due to expansion from an inflatable balloon or some other expansion device. Generally, the treatment site into which the artificial heart implant is expanded is neither perfectly cylindrical nor has a perfectly molded circular cross-sectional shape. Generally, the treatment area is damaged and / or contains plaque, calcium deposits, and / or other materials (e.g., previously implanted medical devices), which causes the shape of the treatment area to be non-cylindrical or to have a non-circular cross-sectional shape. Therefore, an artificial heart implant frame that can better conform to the irregular shape of the treatment site results in an artificial heart implant that fits better into the treatment area and can also result in a reduction of perivalvular leakage or other types of leakage around the outer circumference of the expanded artificial heart implant. Figure 10 illustrates that when angle joint members and / or axial longitudinal members of a frame formed from MoRe or Co-Cr alloy of the same size and configuration are subjected to the same bending force, angle joint members and / or axial longitudinal members of MoRe conform better to the ideal bend shape (IBS) than angle joint members and / or axial longitudinal members of Co-Cr alloy. Two bending tests illustrate that angle joint members and / or axial longitudinal members formed from heat-resistant metal alloys such as MoRe conform to the ideal bend shape 23% and 31% better than angle joint members and / or axial longitudinal members formed from CoCr. The ability to conform to a particular shape depends largely on the rebound of the alloy used to form the angle joint members and / or axial longitudinal members.Angular joint members and / or axial longitudinal members formed from heat-resistant metal alloys, or metal alloys containing at least 15 awt.% rhenium, have been found to conform approximately 15–45% (and all values ​​and ranges in between) better to bending to an ideal bend shape formed by a die than angular joint members and / or axial longitudinal members of the same size formed from Co-Cr alloys, TiAlV alloys, or Ni-Ti alloys. Such improved shape conformability results in improved conformability of extended prosthetic heart valve frames to therapeutic area shapes, as illustrated in Figures 11A and 11B.

[0161] Figure 11A illustrates the fit of an extended frame 500 made of Co-Cr alloy to an irregularly shaped annulus 400 of the heart, where the therapeutic area includes calcium deposition (CD) and leakage area (PVL) around the outer circumference of the extended frame. The extended frame forms an EOA of approximately 585 mm². Because the CoCr alloy cannot readily conform to the irregular shape of the annulus, an open area of ​​approximately 46 mm² is located around the outer circumference of the extended frame, allowing for PVL around the extended TAV. Figure 11B illustrates the fit of an extended frame 600 made of a heat-resistant metal alloy such as MoRe to an irregularly shaped annulus 400 of the heart. Due to the improved ability of the heat-resistant metal alloy to conform to the irregular shape of the annulus, the extended frame forms an EOA of approximately 679 mm². Therefore, only an area of ​​approximately 14 mm² is located around the outer circumference of the extended frame. It is illustrated that an expandable frame formed from a heat-resistant metal alloy provides a 30% or greater fit (e.g., 30–40%, and all values ​​and ranges in between) to the irregularly shaped annulus of the heart compared to a frame of the same shape and size made from Co-Cr alloy. In general, expandable frames formed from a heat-resistant metal alloy, or a metal alloy containing at least 15 awt.% rhenium, provide approximately 10–50% or greater fit (and all values ​​and ranges in between) to irregularly shaped body passages compared to a frame of the same size and configuration made from Co-Cr alloy, TiAlV alloy, or Ni-Ti alloy.

[0162] Figures 12A–12C illustrate percentage area graphs of stress-to-reduction for angular joint members and / or axial longitudinal members formed from TiAlV alloy, CoCr alloy, and MoRe alloy. These graphs illustrate that angular joint members and / or axial longitudinal members of a frame formed from a heat-resistant metal alloy (e.g., MoRe) exhibit improved properties such as strength, yield strength, maximum tensile strength, fatigue ductility, greater deformation tolerance, material integrity between plastic deformation and failure, and durability compared to angular joint members and / or axial longitudinal members of the same size and configuration formed from CoCr alloy or TiAlV alloy. Heat-resistant metal alloys, or metal alloys containing at least 15 awt.% rhenium, can have strengths 1.5–5 times greater (and all values ​​and ranges in between) than Co-Cr alloys, TiAlV alloys, or Ni-Ti alloys.

[0163] As illustrated in Figure 13, angular joint members and / or axial longitudinal members formed from heat-resistant metal alloys such as MoRe alloy have greater stiffness and yield strength compared to angular joint members and / or axial longitudinal members of the same size and configuration formed from Co-Cr alloy, TiAlV alloy, or Ni-Ti alloy.

[0164] Figures 14A to 14C are graphs illustrating the yield strength, ultimate strength, and fatigue ductility of angular joint members and / or axial longitudinal members formed from TiAlV alloys, CoCr alloys, and MoRe alloys after cold working to reduce the cross-sectional area of ​​the alloys. After cold working, heat-resistant metal alloys (e.g., MoRe alloys) have greater fatigue ductility, yield strength, and ultimate strength than Co-Cr alloys and TiAlV alloys. Furthermore, cold working of MoRe alloys results in increased alloy ductility, while CoCr alloys and TiAlV alloys exhibit reduced ductility when additional cold working is applied to the alloys.

[0165] Figure 15 illustrates the hydrophilicity of heat-resistant metal alloys such as MoRe alloys compared to Co-Cr alloys or TiAlV alloys. The hydrophilicity of materials implanted in patients is a crucial property of the material, relating to tissue cell adhesion, cell migration, and cell proliferation. As illustrated in Figure 15, Co-Cr alloys are hydrophobic materials, resulting in a large contact angle (93°±1°) for water droplets (e.g., distilled water) positioned on the surface of the Co-Cr alloy. TiAlV alloys are slightly more hydrophilic than Co-Cr alloys, exhibiting a contact angle of 58°±8° when water droplets are positioned on the surface of the Ti alloy. Heat-resistant metal alloys such as MoRe alloys have much higher hydrophilicity than Co-Cr and TiAlV alloys. When water droplets are positioned on the surface of the MoRe alloy, the MoRe alloy has a contact angle of 37°±3°. Heat-resistant metal alloys, or metal alloys containing at least 15 awt.% rhenium, are generally hydrophilic, with a water droplet contact angle of 25° to 45° (and all values ​​and ranges in between) on the surface of the heat-resistant metal alloy, and typically 30 to 42°.

[0166] Compared to expanded frames of artificial heart valves of the same size and configuration formed from Co-Cr alloy, TiAlV alloy, or Ni-Ti alloy, the reduced rebound, improved bending conformity, and greater radial strength of expanded frames of artificial heart valves formed at least partially from heat-resistant metal alloys or metal alloys containing at least 15 awt.% rhenium result in the following non-limiting advantages: 1) Formation of artificial heart valve frames with thinner angular joint members, axial longitudinal members, and / or strut joints: This results in i) safer vascular access when inserting the artificial heart valve into the treatment area through body passages, and / or ii) a reduced risk of bleeding and / or injury to body passages and / or treatment area when the artificial heart valve is delivered to and / or expanded in the treatment area; and 2) Easier delivery of the artificial heart valve to the treatment area: This results in i) reduced trauma to body passages (e.g., blood vessels, aortic arch trauma, etc.) during insertion and / or expansion of the artificial heart valve in the treatment area, and / or nerves 3) Reduced risk of complications - stroke, and / or vii) less rebound: This may result in i) reduced compression profile size, ii) increased fit of the expanded prosthetic valve in the therapeutic area after expansion in the therapeutic area, iii) increased radial strength of the prosthetic valve frame after expansion in the therapeutic area, iv) a single compression cycle only requiring the prosthetic valve to be compressed on a balloon catheter or other type of delivery device, v) a reduced incidence of damage to components of the prosthetic valve (e.g., angular joint members, axial longitudinal members, strut joints, and / or other components of the expandable frame, leaflets, skirts, coatings, etc.) during compression, expansion, and operation of the medical device, vi) a larger effective orifice area (EOA) of the prosthetic valve after expansion of the medical device, vi) reduced pulmonary valve regurgitation (PVR) after expansion of the prosthetic valve in the therapeutic area, and / or vii) the need for only a single expansion cycle of the balloon on a balloon catheter or other expansion mechanism to fully expand the prosthetic valve.Furthermore / or 4) the creation of artificial heart valves with superior material biological properties: this would result in I) improved adhesion and / or proliferation of tissues on or around the artificial heart valve, II) reduced adverse tissue reactions caused by the artificial heart valve, III) reduced toxicity of the artificial heart valve, IV) a potential reduction in valve thrombosis over the lifetime of the artificial heart valve, and / or V) a reduction in the incidence of infection over the lifetime of the artificial heart valve.

[0167] Therefore, in order to efficiently achieve the objectives described above, and to allow certain modifications to the described structures without departing from the spirit and scope of this disclosure, all matters included in the above description and shown in the accompanying drawings are intended to be interpreted as illustrative and not restrictive. This disclosure has been described with reference to preferred and alternative embodiments. Modifications and changes will be apparent to those skilled in the art upon reading and understanding the detailed considerations of this disclosure provided herein. This disclosure is intended to include all such modifications and changes, insofar as they fall within the scope of this disclosure. It should also be understood that the following claims are intended to encompass all the general and specific features of this disclosure as described herein, as well as, as a matter of language, all descriptions of the scope of this disclosure that may lie between them.

[0168] To assist the Patent Office and any reader of this application and any resulting patents in interpreting the claims attached herein, the applicant does not intend any of the attached claims or claim elements to exercise § 112(f) of the United States Patent Act unless the words “means for” or “steps for” are expressly used in a particular claim.

[0169] (Note) (Note 1) An expandable artificial heart valve comprising an expandable metal frame and at least one leaflet connected to the expandable metal frame, wherein the expandable metal frame is configured to be crimped and to further expand from a crimped orientation to an expandable orientation at the opening of a body passage, the expandable metal frame having a distal end and a proximal end, and the expandable metal frame is formed of a) an open-cell configuration comprising a plurality of frame cells and at least two rows of frame cells, and / or b) a material having less than 10% rebound, so as to result in reduced rebound of the expandable metal frame when expanded from the crimped orientation to the expandable orientation, and the expandable metal frame However, the following characteristics: i) at least 70-100% of the expandable metal frame is formed of a metal alloy having a yield strength of at least 110 ksi; ii) at least 70-100% of the expandable metal frame is formed of a metal alloy having an elastic modulus of at least 35,000 ksi; iii) a frame geometry having a maximum of 9 frame cells per horizontal row; iv) at least 70-100% of the expandable metal frame is formed of a rhenium-containing metal alloy containing at least 0.1 wt% rhenium and one or more metals selected from the group consisting of Mo, Cr, Co, Ni, Ti, Ta, Nb, Zr, and W; v) at least 70-100% of the expandable metal frame is at least 0.vi) The expandable metal frame is formed from a rhenium-containing metal alloy comprising 1 wt% rhenium and one or more metals selected from the group consisting of Mo, Cr, Co, Ni, Ti, Ta, Nb, Zr, and W, wherein the metal alloy is partially or completely formed from metal powders sintered together, vii) when the expandable metal frame is plastically deformed, the expandable metal frame has a shortening of 20% or less, vii) each of the cells comprises at least one axial longitudinal member and at least two angular joint members, each of the angular joint members being the length of the angular joint member viiii) Each of the cells comprises at least one axial longitudinal member and at least two angular joint members, each of the angular joint members comprising multiple arcuate portions along the handed length, and one or more of the axial longitudinal members having a continuous linear shape for at least 80% of the axial longitudinal length of the axial longitudinal member, and / or ix) The outer surface of the expandable frame comprises two or more of the following:

[0170] (Note 2) The expandable artificial heart valve according to Appendix 1, wherein one or more of the frame cells include at least two axial longitudinal members and at least two angular joint members, each of the angular joint members including a first arm and a second arm connected to an articulation joint, the articulation joint having an arc-shaped or semicircular portion, and each of the axial longitudinal members having a continuous linear shape for at least 90% of the longitudinal length of the axial longitudinal member.

[0171] (Note 3) An expandable artificial heart valve according to Appendix 1, wherein at least one axial longitudinal member within the row of frame cells is aligned along the same longitudinal axis to form a group of aligned axial longitudinal members, the group of aligned axial longitudinal members extends completely from the distal end to the proximal end of the expandable metal frame, and during expansion and / or compression of the expandable metal frame, the total longitudinal length of each of the frame cells within the row of frame cells does not exceed the longitudinal length of each of the axial longitudinal members within the frame cell.

[0172] (Note 4) An expandable artificial heart valve as described in Appendix 2, wherein at least one axial longitudinal member within a row of frame cells is aligned along the same longitudinal axis to form a group of aligned axial longitudinal members, the group of aligned axial longitudinal members extends completely from the distal end to the proximal end of the expandable metal frame, and during expansion and / or compression of the expandable metal frame, the total longitudinal length of each of the frame cells within a row of frame cells does not exceed the longitudinal length of each of the axial longitudinal members within the frame cell.

[0173] (Note 5) The expandable artificial heart valve according to Appendix 1, wherein one or more of the angle joint members include one or more independent radii along their longitudinal lengths.

[0174] (Note 6) An expandable artificial heart valve according to any one of the appendices 2 to 4, wherein one or more of the angle joint members include one or more independent radii along their longitudinal lengths.

[0175] (Note 7) The expandable artificial heart valve as described in Appendix 1, wherein the sum of the longitudinal lengths of the angular joint members is equal to or greater than the sum of the longitudinal lengths of the axial longitudinal members.

[0176] (Note 8) An expandable artificial heart valve according to any one of the appendices 2 to 6, wherein the sum of the longitudinal lengths of the angular joint members is equal to or greater than the sum of the longitudinal lengths of the axial longitudinal members.

[0177] (Note 9) The expandable artificial heart valve according to Appendix 1, wherein the longitudinal length of the expandable frame is equal to the longitudinal length of at least one of the aligned group of axial longitudinal members during expansion and compression of the expandable frame.

[0178] (Note 10) An expandable artificial heart valve according to any one of Appendices 2 to 8, wherein the longitudinal length of the expandable frame is equal to the longitudinal length of at least one of the group of aligned axial longitudinal members during expansion and compression of the expandable frame.

[0179] (Note 11) The expandable artificial heart valve according to Appendix 1, wherein the longitudinal length between the proximal end of the expandable frame and the commissure mounting area on the expandable frame is constant during expansion and / or crimping of the expandable frame.

[0180] (Note 12) An expandable artificial heart valve according to any one of appendices 2 to 10, wherein the longitudinal length between the proximal end of the expandable frame and the commissure attachment area on the expandable frame is constant during expansion and / or crimping of the expandable frame.

[0181] (Note 13) The expandable artificial heart valve according to Appendix 1, further comprising a commissure alignment marker positioned within the expandable frame, wherein the commissure alignment marker is formed of the same material as the material used to form the expandable frame.

[0182] (Note 14) An expandable artificial heart valve according to any one of Appendices 2 to 12, further comprising a commissure alignment marker positioned within the expandable frame, wherein the commissure alignment marker is formed of the same material as the material used to form the expandable frame.

[0183] (Note 15) The material used to form the commissure alignment marker is 10 mg / cm³ 3 An expandable artificial heart valve, as described in Appendix 13, which is a metal with ultra-high density.

[0184] (Note 16) The material used to form the commissure alignment marker is 10 mg / cm³ 3 An expandable artificial heart valve, as described in Appendix 14, which is a metal with ultra-high density.

[0185] (Note 17) The expandable artificial heart valve as described in Appendix 13, wherein the commissure alignment marker is attached to the commissure mounting area.

[0186] (Note 18) An expandable artificial heart valve according to any one of appendices 14 to 16, wherein the commissure alignment marker is attached to the commissure mounting area.

[0187] (Note 19) The expandable artificial heart valve according to Appendix 1, wherein the distal row of frame cells on the expandable frame contains an odd number of frame cells.

[0188] (Note 20) An expandable artificial heart valve according to any one of appendices 2 to 18, wherein the distal row of frame cells on the expandable frame contains an odd number of frame cells.

[0189] (Note 21) The expandable artificial heart valve according to Appendix 19, wherein the distalmost row of frame cells on the expandable frame comprises nine frame cells.

[0190] (Note 22) The expandable artificial heart valve according to Appendix 20, wherein the distalmost row of frame cells on the expandable frame comprises nine frame cells.

[0191] (Note 23) The expandable artificial heart valve according to Appendix 1, wherein the angular joint members within the frame cell in the same column and / or same row of the frame cell have the same longitudinal length.

[0192] (Note 24) An expandable artificial heart valve according to any one of Appendix 2 to 22, wherein the angular joint members within the frame cell in the same column and / or the same row of the frame cell have the same longitudinal length.

[0193] (Note 25) An expandable artificial heart valve as described in Appendix 23, wherein all of the angular joint members within the frame cell have the same longitudinal length.

[0194] (Note 26) The expandable artificial heart valve as described in Appendix 24, wherein all of the angular joint members within the frame cell have the same longitudinal length.

[0195] (Note 27) The expandable artificial heart valve as described in Appendix 1, wherein the vertices of adjacently positioned frame cells within adjacent rows are aligned within 5% of the total length in the handed direction of the angular joint member.

[0196] (Note 28) An expandable artificial heart valve according to any one of appendices 2 to 26, wherein the vertices of frame cells positioned adjacent to each other within adjacent rows are aligned within 5% of the total length in the handed direction of the angular joint member.

[0197] (Note 29) The expandable artificial heart valve as described in Appendix 1, wherein each region of the most distal row of the frame cells and each region of the nearest end of the frame cells on the expandable frame do not differ by more than 20%.

[0198] (Note 30) An expandable artificial heart valve according to any one of the appendices 2 to 28, wherein each region of the most distal row of the frame cells and each region of the nearest end of the frame cells on the expandable frame do not differ by more than 20%.

[0199] (Note 31) The expandable artificial heart valve according to Appendix 1, wherein the material of the expandable frame is at least partially made from a metal alloy containing less than 1% by weight of nickel and / or less than 0.1% by weight of cobalt.

[0200] (Note 32) An expandable artificial heart valve according to any one of Appendix 2 to 30, wherein the material of the expandable frame is at least partially made from a metal alloy containing less than 1% by weight of nickel and / or less than 0.1% by weight of cobalt.

[0201] (Note 33) An artificial heart valve for implantation in the heart, the artificial heart valve comprising: an expandable metal frame; a leaflet structure supported by the expandable metal frame; and an inner skirt fixed to the expandable metal frame, wherein the expandable metal frame is configured to expand from a compression orientation to an expansion orientation when the artificial heart valve is positioned at a treatment site in the heart, and the expandable metal frame comprises a plurality of angular joint members and a plurality of axial longitudinal members, wherein the angular joint members and the axial longitudinal members are connected to one another. An artificial heart valve comprising, an expandable metal frame forming a plurality of cells arranged in rows, each of which includes at least one axial longitudinal member and at least two angular joint members, each of which includes a plurality of arcuate portions along the longitudinal length of the angular joint member, and one or more of the axial longitudinal members having a continuous linear shape for at least 80% of the longitudinal length of the axial longitudinal member, wherein when the expandable metal frame is plastically deformed, the expandable metal frame has a shortening of 20% or less.

[0202] (Note 34) The artificial heart valve according to Appendix 33, wherein, when the expandable metal frame is in the expanded orientation, one or more of the axial longitudinal members have a longitudinal length that is 70-100% of the longitudinal length of the expandable metal frame.

[0203] (Note 35) The expandable metal frame includes a first strut row, a second strut row, and a third strut row, each of the first, second, and third strut rows including a plurality of angle joint members, each of the angle joint members in the first strut row including a first end and a second end, the first end of each of the angle joint members being connected to one of the axial longitudinal members, and the second end of each of the angle joint members being connected to a different axial longitudinal member, each of the angle joint members in the second strut row including a first end and a second end, the first ends of a plurality or all of the angle joint members being connected to one of the axial longitudinal members, and the second ends of a plurality or all of the angle joint members being different The artificial heart valve according to Appendix 33, wherein the angular joint members in the third strut row are connected to an axial longitudinal member, and each of the angular joint members in the third strut row includes a first end and a second end, and the multiple or all first ends of the multiple or all of the angular joint members are connected to one of the axial longitudinal members, and the multiple or all second ends of the multiple or all of the angular joint members are connected to different axial longitudinal members, and when the expandable metal frame is in the expanded orientation, all of the angular joint members in the first strut row are separated from the angular joint members in the second and third strut rows, and when the expandable metal frame is in the expanded orientation, all of the angular joint members in the second strut row are separated from the angular joint members in the third strut row.

[0204] (Note 36) The expandable metal frame includes a first strut row, a second strut row, and a third strut row, each of the first, second, and third strut rows including a plurality of angle joint members, each of the angle joint members in the first strut row including a first end and a second end, the first end of each of the angle joint members being connected to one of the axial longitudinal members, and the second end of each of the angle joint members being connected to a different axial longitudinal member, each of the angle joint members in the second strut row including a first end and a second end, the first ends of a plurality or all of the angle joint members being connected to one of the axial longitudinal members, and the second ends of a plurality or all of the angle joint members being different The artificial heart valve according to Appendix 34, wherein the angular joint members in the third strut row are connected to an axial longitudinal member, and each of the angular joint members in the third strut row includes a first end and a second end, and the multiple or all first ends of the multiple or all of the angular joint members are connected to one of the axial longitudinal members, and the multiple or all second ends of the multiple or all of the angular joint members are connected to different axial longitudinal members, and when the expandable metal frame is in the expanded orientation, all of the angular joint members in the first strut row are separated from the angular joint members in the second and third strut rows, and when the expandable metal frame is in the expanded orientation, all of the angular joint members in the second strut row are separated from the angular joint members in the third strut row.

[0205] (Note 37) The artificial heart valve according to Appendix 33, wherein the expandable metal frame includes a fourth strut row, the fourth strut row includes a plurality of angle joint members, each of the angle joint members in the first strut row includes a first end, a second end, and each of the plurality or all of the first ends of the angle joint members is connected to one of the axial longitudinal members, and each of the plurality or all of the second ends of the angle joint members is connected to a different axial longitudinal member, and when the expandable metal frame is in the expanded orientation, all of the angle joint members in the fourth strut row are separated from the angle joint members in the first, second, and third strut rows.

[0206] (Note 38) An artificial heart valve according to any one of appendices 34 to 36, wherein the expandable metal frame includes a fourth strut row, the fourth strut row includes a plurality of angle joint members, each of the angle joint members in the first strut row includes a first end, a second end, and each of the plurality or all of the first ends of the angle joint members is connected to one of the axial longitudinal members, and each of the plurality or all of the second ends of the angle joint members is connected to a different axial longitudinal member, and when the expandable metal frame is in the expanded orientation, all of the angle joint members in the fourth strut row are separated from the angle joint members in the first, second, and third strut rows.

[0207] (Note 39) The artificial heart valve according to Appendix 33, wherein the plurality of axial longitudinal members include first and second axial longitudinal member segments, the first and second axial longitudinal member segments having different longitudinal lengths, each of the first and second axial longitudinal member segments includes a top end and a bottom end, the top end of each of the first axial longitudinal member segments being connected to a) the bottom end of the second axial longitudinal member segment and b) two of the angular joint members, and the top end of the second end of each of the second axial longitudinal member segments being connected to two of the angular joint members and / or the bottom portion of one of the frame opening arrangements.

[0208] (Note 40) An artificial heart valve according to any one of appendices 34 to 38, wherein the plurality of axial longitudinal members include first and second axial longitudinal member segments, the longitudinal lengths of the first and second axial longitudinal member segments being different, and each of the first and second axial longitudinal member segments includes a top end and a bottom end, the top end of each of the first axial longitudinal member segments being connected to a) the bottom end of the second axial longitudinal member segment and b) two of the angular joint members, and the top end of the second end of each of the second axial longitudinal member segments being connected to the bottom portion of two of the angular joint members and / or one of the frame opening arrangements.

[0209] (Note 41) The artificial heart valve according to Appendix 33, wherein the plurality of axial longitudinal members include a third axial longitudinal member segment, the longitudinal length of the third axial longitudinal member segment being different from the longitudinal length of the first and / or second axial longitudinal member segments, the third axial longitudinal member segment including a top end and a bottom end, the bottom end of each of the third axial longitudinal member segments being connected to two of the angular joint members, a) the top end of the second axial longitudinal member segment and / or b) the angular joint members, and the top end of each of the third ends of the second axial longitudinal member segment being connected to two of the angular joint members.

[0210] (Note 42) An artificial heart valve according to any one of appendices 34 to 40, wherein the plurality of axial longitudinal members include a third axial longitudinal member segment, the longitudinal length of the third axial longitudinal member segment being different from the longitudinal length of the first and / or second axial longitudinal member segments, the third axial longitudinal member segment includes a top end and a bottom end, the bottom end of each of the third axial longitudinal member segments being connected to two of the angular joint members, a) the top end of the second axial longitudinal member segment and / or b) the angular joint members, and the top end of each of the third ends of the second axial longitudinal member segment being connected to two of the angular joint members.

[0211] (Note 43) The artificial heart valve according to Appendix 33, wherein each of the angle joint members includes a centrally located arc-shaped portion and first and second arms extending from each side of the arc-shaped portion, the first arm on each of the angle joint members having a first arm end, the second arm on each of the angle joint members having a second arm end, and each of the first arm ends being connected to a) one of the axial longitudinal members and / or b) one of the frame opening arrangements, and the longitudinal length of one or both of the first and second arms of each of the angle joint members is greater than the width or longitudinal length of the semicircular portion.

[0212] (Note 44) An artificial heart valve according to any one of the appendices 34 to 42, wherein each of the angle joint members includes a centrally located arc-shaped portion and first and second arms extending from each side of the arc-shaped portion, the first arm on each of the angle joint members having a first arm end, the second arm on each of the angle joint members having a second arm end, and each of the first arm ends being connected to a) one of the axial longitudinal members and / or b) one of the frame opening arrangements, and the longitudinal length of one or both of the first and second arms of each of the angle joint members is greater than the width or longitudinal length of the semicircular portion.

[0213] (Note 45) The artificial heart valve according to Appendix 33, wherein each of the first and second arms includes one to three wavy sections.

[0214] (Note 46) An artificial heart valve according to any one of appendices 34 to 44, wherein each of the first and second arms includes one to three wavy sections.

[0215] (Note 47) The artificial heart valve according to Appendix 33, wherein the expandable metal frame is partially or completely formed of a heat-resistant metal alloy, or a metal alloy containing at least 15 awt.% rhenium, or a heat-resistant metal alloy, or a metal alloy containing at least 5 awt.% rhenium, and the metal alloy is not a shape memory alloy.

[0216] (Note 48) The artificial heart valve according to any one of the appendices 34 to 46, wherein the expandable metal frame is partially or completely formed of a heat-resistant metal alloy, or a metal alloy containing at least 15 awt.% rhenium, or a heat-resistant metal alloy, or a metal alloy containing at least 5 awt.% rhenium, and the metal alloy is not a shape memory alloy.

[0217] (Note 49) The artificial heart valve according to Appendix 33, wherein the expandable metal frame is formed of a material having reduced rebound when bent such that the expandable frame has a rebound of 5% or less when the expandable metal frame is compressed into a compressed state, b) formed of a material having reduced rebound when bent such that the expandable frame has a rebound of 5% or less when the expandable metal frame is expanded from a compressed state to an expanded state, and / or c) the expandable metal frame has a shortening ratio of less than 20% when expanded from the compressed state.

[0218] (Note 50) The artificial heart valve according to any one of the appendices 34 to 48, wherein the expandable metal frame is formed of a material having reduced rebound when bent such that the expandable frame has a rebound of 5% or less when the expandable metal frame is compressed into a compressed state, b) the expandable metal frame is formed of a material having reduced rebound when bent such that the expandable frame has a rebound of 5% or less when the expandable metal frame is expanded from a compressed state to an expanded state, and / or c) the expandable metal frame has a shortening ratio of less than 20% when expanded from the compressed state.

[0219] (Note 51) The artificial heart valve according to Appendix 33, further comprising a leaflet structure supported by the expandable metal frame, and an inner skirt fixed to the expandable metal frame.

[0220] (Note 52) An artificial heart valve according to any one of appendices 34 to 50, further comprising a leaflet structure supported by the expandable metal frame, and an inner skirt fixed to the expandable metal frame.

[0221] (Note 53) The artificial heart valve according to Appendix 51, wherein the leaflet structure comprises a plurality of leaflets, each of which has an upper edge portion, a lower edge portion, and two side flaps, each side flap being connected to an adjacent side flap of another leaflet, and at least a portion of the leaflet structure is connected to the expandable metal frame.

[0222] (Note 54) The artificial heart valve according to Appendix 52, wherein the leaflet structure comprises a plurality of leaflets, each of which has an upper edge portion, a lower edge portion, and two lateral flaps, each lateral flap being connected to an adjacent lateral flap of another leaflet, and at least a portion of the leaflet structure is connected to the expandable metal frame.

[0223] (Note 55) The artificial heart valve according to Appendix 33, further comprising an outer skirt, the outer skirt being fully positioned around a portion of the outer surface of the expandable metal frame, and the outer skirt being connected to the expandable metal frame.

[0224] (Note 56) An artificial heart valve according to any one of appendices 34 to 54, further comprising an outer skirt, the outer skirt being fully positioned around a portion of the outer surface of the expandable metal frame, and the outer skirt being connected to the expandable metal frame.

[0225] (Note 57) The artificial heart valve according to Appendix 33, wherein the expandable metal frame is partially or completely formed of a rhenium-containing metal alloy comprising at least 0.1 wt% rhenium and one or more metals selected from the group consisting of Mo, Cr, Co, Ni, Ti, Ta, Nb, Zr, and W, and the metal alloy is partially or completely formed from metal powders sintered together.

[0226] (Note 58) The artificial heart valve according to any one of the appendices 34 to 56, wherein the expandable metal frame is partially or completely formed of a rhenium-containing metal alloy comprising at least 0.1 wt% rhenium and one or more metals selected from the group consisting of Mo, Cr, Co, Ni, Ti, Ta, Nb, Zr, and W, and the metal alloy is partially or completely formed from metal powders sintered together.

Claims

1. An expandable artificial heart valve comprising an expandable metal frame and at least one leaflet connected to the expandable metal frame, wherein the expandable metal frame is configured to be crimped and to further expand from a crimped orientation to an expandable orientation at an opening of a body passage, the expandable metal frame having a distal end and a proximal end, and the expandable metal frame comprising a) an open cell configuration including a plurality of frame cells and at least two rows of frame cells, and / or b) a material having less than 10% rebound The frame is formed in such a way that, when expanded from the compression orientation to the expansion orientation, it results in reduced rebound of the expandable metal frame, and the expandable metal frame has the following characteristics: i) at least 70-100% of the expandable metal frame is formed of a metal alloy having a yield strength of at least 110 ksi; ii) at least 70-100% of the expandable metal frame is formed of a metal alloy having an elastic modulus of at least 35,000 ksi; iii) the frame geometry has a maximum of nine frame cells per horizontal row. iv) At least 70 to 100% of the expandable metal frame is formed of a rhenium-containing metal alloy comprising at least 0.1% by weight of rhenium and one or more metals selected from the group consisting of Mo, Cr, Co, Ni, Ti, Ta, Nb, Zr, and W; v) At least 70 to 100% of the expandable metal frame is formed of a rhenium-containing metal alloy comprising at least 0.1% by weight of rhenium and one or more metals selected from the group consisting of Mo, Cr, Co, Ni, Ti, Ta, Nb, Zr, and W, wherein the metal alloy is vi) When the expandable metal frame is plastically deformed, the expandable metal frame has a shortening of 20% or less, vii) Each of the cells comprises at least one axial longitudinal member and at least two angular joint members, and each of the angular joint members comprises a plurality of arcuate portions along the longitudinal length of the angular joint member, viiii) Each of the cells comprises at least one axial longitudinal member and at least two angular joint members, and each of the angular joint membersAn expandable artificial heart valve having a plurality of arc-shaped portions along the longitudinal length of the angular joint member, one or more of the axial longitudinal members having a continuous linear shape for at least 80% of the longitudinal length of the axial longitudinal member, and / or ix) two or more of the outer surfaces of the expandable frame having a reinforcing coating.

2. The expandable artificial heart valve according to claim 1, wherein one or more of the frame cells include at least two axial longitudinal members and at least two angular joint members, each of the angular joint members including a first arm and a second arm connected to an articulation joint, the articulation joint having an arc-shaped or semicircular portion, and each of the axial longitudinal members having a continuous linear shape for at least 90% of the longitudinal length of the axial longitudinal member.

3. An expandable artificial heart valve according to claim 1, wherein at least one axial longitudinal member in the row of the frame cell is aligned along the same longitudinal axis to form an aligned group of axial longitudinal members, the aligned group of axial longitudinal members extends completely from the distal end to the proximal end of the expandable metal frame, and during expansion and / or compression of the expandable metal frame, the total longitudinal length of each of the frame cells in the row of the frame cell does not exceed the longitudinal length of each of the axial longitudinal members in the frame cell.

4. An expandable artificial heart valve according to claim 2, wherein at least one axial longitudinal member in a row of frame cells is aligned along the same longitudinal axis to form a group of aligned axial longitudinal members, the group of aligned axial longitudinal members extends completely from the distal end to the proximal end of the expandable metal frame, and during expansion and / or compression of the expandable metal frame, the total longitudinal length of each of the frame cells in a row of frame cells does not exceed the longitudinal length of each of the axial longitudinal members in the frame cell.

5. The expandable artificial heart valve according to claim 1, wherein one or more of the angle joint members include one or more independent radii along their longitudinal lengths.

6. An expandable artificial heart valve according to any one of claims 2 to 4, wherein one or more of the angle joint members include one or more independent radii along their longitudinal lengths.

7. The expandable artificial heart valve according to claim 1, wherein the sum of the longitudinal lengths of the angular joint members is equal to or greater than the sum of the longitudinal lengths of the axial longitudinal members.

8. The expandable artificial heart valve according to any one of claims 2 to 6, wherein the sum of the longitudinal lengths of the angular joint members is equal to or greater than the sum of the longitudinal lengths of the axial longitudinal members.

9. The expandable artificial heart valve according to claim 1, wherein the longitudinal length of the expandable frame is equal to the longitudinal length of at least one of the aligned group of axial longitudinal members during expansion and compression of the expandable frame.

10. An expandable artificial heart valve according to any one of claims 2 to 8, wherein the longitudinal length of the expandable frame is equal to the longitudinal length of at least one of the aligned group of axial longitudinal members during expansion and compression of the expandable frame.

11. The expandable artificial heart valve according to claim 1, wherein the longitudinal length between the proximal end of the expandable frame and the commissure attachment area on the expandable frame is constant during expansion and / or crimping of the expandable frame.

12. An expandable artificial heart valve according to any one of claims 2 to 10, wherein the longitudinal length between the proximal end of the expandable frame and the commissure mounting area on the expandable frame is constant during expansion and / or crimping of the expandable frame.

13. The expandable artificial heart valve according to claim 1, further comprising a commissure alignment marker positioned within the expandable frame, wherein the commissure alignment marker is formed of the same material as the material used to form the expandable frame.

14. An expandable artificial heart valve according to any one of claims 2 to 12, further comprising a commissure alignment marker positioned within the expandable frame, wherein the commissure alignment marker is formed of the same material as the material used to form the expandable frame.

15. The material used to form the commissure alignment marker is 10 mg / cm² ３ The expandable artificial heart valve according to claim 13, wherein the metal is ultra-high density.

16. The material used to form the commissure alignment marker is 10 mg / cm² ３ The expandable artificial heart valve according to claim 14, wherein the metal is ultra-high density.

17. The expandable artificial heart valve according to claim 13, wherein the commissure alignment marker is attached to the commissure mounting area.

18. The expandable artificial heart valve according to any one of claims 14 to 16, wherein the commissure alignment marker is attached to the commissure mounting area.

19. The expandable artificial heart valve according to claim 1, wherein the most distal row of frame cells on the expandable frame includes an odd number of frame cells.

20. The expandable artificial heart valve according to any one of claims 2 to 18, wherein the most distal row of frame cells on the expandable frame includes an odd number of frame cells.

21. The expandable artificial heart valve according to claim 19, wherein the distalmost row of frame cells on the expandable frame comprises nine frame cells.

22. The expandable artificial heart valve according to claim 20, wherein the distalmost row of frame cells on the expandable frame comprises nine frame cells.

23. The expandable artificial heart valve according to claim 1, wherein the angular joint members within the frame cell in the same column and / or the same row of the frame cell have the same longitudinal length.

24. The expandable artificial heart valve according to any one of claims 2 to 22, wherein the angular joint members within the frame cell in the same column and / or the same row of the frame cell have the same longitudinal length.

25. The expandable artificial heart valve according to claim 23, wherein all of the angle joint members within the frame cell have the same longitudinal length.

26. The expandable artificial heart valve according to claim 24, wherein all of the angular joint members within the frame cell have the same longitudinal length.

27. The expandable artificial heart valve according to claim 1, wherein the vertices of adjacently positioned frame cells within adjacent rows are aligned within 5% of the total length in the handed direction of the angular joint member.

28. The expandable artificial heart valve according to any one of claims 2 to 26, wherein the vertices of adjacently positioned frame cells within adjacent rows are aligned within 5% of the total length in the handed direction of the angular joint member.

29. The expandable artificial heart valve according to claim 1, wherein each region of the most distal row of the frame cells and each region of the nearest end of the frame cells on the expandable frame do not differ by more than 20%.

30. An expandable artificial heart valve according to any one of claims 2 to 28, wherein each region of the most distal row of the frame cells and each region of the nearest end of the frame cells on the expandable frame do not differ by more than 20%.

31. The expandable artificial heart valve according to claim 1, wherein the material of the expandable frame is at least partially made from a metal alloy containing less than 1% by weight of nickel and / or less than 0.1% by weight of cobalt.

32. The expandable artificial heart valve according to any one of claims 2 to 30, wherein the material of the expandable frame is at least partially made from a metal alloy containing less than 1% by weight of nickel and / or less than 0.1% by weight of cobalt.

33. An artificial heart valve for implantation in the heart, the artificial heart valve comprising: an expandable metal frame; a leaflet structure supported by the expandable metal frame; and an inner skirt fixed to the expandable metal frame, wherein the expandable metal frame is configured to expand from a compression orientation to an expansion orientation when the artificial heart valve is positioned at a treatment site in the heart, and the expandable metal frame comprises a plurality of angular joint members and a plurality of axial longitudinal members, wherein the angular joint members and the axial longitudinal members are connected to one another. An artificial heart valve comprising, an expandable metal frame forming a plurality of cells arranged in rows, each of which includes at least one axial longitudinal member and at least two angular joint members, each of which includes a plurality of arcuate portions along the longitudinal length of the angular joint member, and one or more of the axial longitudinal members having a continuous linear shape for at least 80% of the longitudinal length of the axial longitudinal member, wherein when the expandable metal frame is plastically deformed, the expandable metal frame has a shortening of 20% or less.

34. The artificial heart valve according to claim 33, wherein when the expandable metal frame is in the expanded orientation, one or more of the axial longitudinal members have a longitudinal length that is 70 to 100% of the longitudinal length of the expandable metal frame.

35. The expandable metal frame includes a first strut row, a second strut row, and a third strut row, each of the first, second, and third strut rows including a plurality of angle joint members, each of the angle joint members in the first strut row including a first end and a second end, the first end of each of the angle joint members being connected to one of the axial longitudinal members, and the second end of each of the angle joint members being connected to a different axial longitudinal member, each of the angle joint members in the second strut row including a first end and a second end, the first ends of a plurality or all of the angle joint members being connected to one of the axial longitudinal members, and the second ends of a plurality or all of the angle joint members being different The artificial heart valve according to claim 33, wherein the angular joint members in the third strut row are connected to an axial longitudinal member, and each of the angular joint members in the third strut row includes a first end and a second end, and the multiple or all first ends of the multiple or all of the angular joint members are connected to one of the axial longitudinal members, and the multiple or all second ends of the multiple or all of the angular joint members are connected to a different axial longitudinal member, and when the expandable metal frame is in the expanded orientation, all of the angular joint members in the first strut row are separated from the angular joint members in the second and third strut rows, and when the expandable metal frame is in the expanded orientation, all of the angular joint members in the second strut row are separated from the angular joint members in the third strut row.

36. The expandable metal frame includes a first strut row, a second strut row, and a third strut row, each of the first, second, and third strut rows including a plurality of angle joint members, each of the angle joint members in the first strut row including a first end and a second end, the first end of each of the angle joint members being connected to one of the axial longitudinal members, and the second end of each of the angle joint members being connected to a different axial longitudinal member, each of the angle joint members in the second strut row including a first end and a second end, the first ends of a plurality or all of the angle joint members being connected to one of the axial longitudinal members, and the second ends of a plurality or all of the angle joint members being different The artificial heart valve according to claim 34, wherein the angular joint members in the third strut row are connected to an axial longitudinal member, and each of the angular joint members in the third strut row includes a first end and a second end, and the multiple or all first ends of the multiple or all of the angular joint members are connected to one of the axial longitudinal members, and the multiple or all second ends of the multiple or all of the angular joint members are connected to a different axial longitudinal member, and when the expandable metal frame is in the expanded orientation, all of the angular joint members in the first strut row are separated from the angular joint members in the second and third strut rows, and when the expandable metal frame is in the expanded orientation, all of the angular joint members in the second strut row are separated from the angular joint members in the third strut row.

37. The artificial heart valve according to claim 33, wherein the expandable metal frame includes a fourth strut row, the fourth strut row includes a plurality of angle joint members, each of the angle joint members in the first strut row includes a first end and a second end, each of the plurality or all of the first ends of the angle joint members is connected to one of the axial longitudinal members, and each of the plurality or all of the second ends of the angle joint members is connected to a different axial longitudinal member, and when the expandable metal frame is in the expanded orientation, all of the angle joint members in the fourth strut row are separated from the angle joint members in the first, second and third strut rows.

38. The artificial heart valve according to any one of claims 34 to 36, wherein the expandable metal frame includes a fourth strut row, the fourth strut row includes a plurality of angle joint members, each of the angle joint members in the first strut row includes a first end and a second end, each of the plurality or all of the first ends of the angle joint members is connected to one of the axial longitudinal members, and each of the plurality or all of the second ends of the angle joint members is connected to a different axial longitudinal member, and when the expandable metal frame is in the expanded orientation, all of the angle joint members in the fourth strut row are separated from the angle joint members in the first, second and third strut rows.

39. The artificial heart valve according to claim 33, wherein the plurality of axial longitudinal members include first and second axial longitudinal member segments, the first and second axial longitudinal member segments having different longitudinal lengths, each of the first and second axial longitudinal member segments includes a top end and a bottom end, the top end of each of the first axial longitudinal member segments is connected to a) the bottom end of the second axial longitudinal member segment and b) two of the angular joint members, and the top end of the second end of each of the second axial longitudinal member segments is connected to the bottom portion of two of the angular joint members and / or one of the frame opening arrangements.

40. An artificial heart valve according to any one of claims 34 to 38, wherein the plurality of axial longitudinal members include first and second axial longitudinal member segments, the first and second axial longitudinal member segments having different longitudinal lengths, each of the first and second axial longitudinal member segments includes a top end and a bottom end, the top end of each of the first axial longitudinal member segments being connected to a) the bottom end of the second axial longitudinal member segment and b) two of the angular joint members, and the top end of the second end of each of the second axial longitudinal member segments being connected to the bottom portion of two of the angular joint members and / or one of the frame opening arrangements.

41. The artificial heart valve according to claim 33, wherein the plurality of axial longitudinal members include a third axial longitudinal member segment, the longitudinal length of the third axial longitudinal member segment being different from the longitudinal length of the first and / or second axial longitudinal member segments, the third axial longitudinal member segment includes a top end and a bottom end, the bottom end of each of the third axial longitudinal member segments being connected to two of the angular joint members, a) the top end of the second axial longitudinal member segment and / or b) the angular joint members, and the top end of each of the third ends of the second axial longitudinal member segment being connected to two of the angular joint members.

42. An artificial heart valve according to any one of claims 34 to 40, wherein the plurality of axial longitudinal members include a third axial longitudinal member segment, the longitudinal length of the third axial longitudinal member segment being different from the longitudinal length of the first and / or second axial longitudinal member segments, the third axial longitudinal member segment includes a top end and a bottom end, the bottom end of each of the third axial longitudinal member segments being connected to two of the angular joint members, a) the top end of the second axial longitudinal member segment and / or b) the angular joint members, and the top end of each of the third ends of the second axial longitudinal member segment being connected to two of the angular joint members.

43. The artificial heart valve according to claim 33, wherein each of the angle joint members includes a centrally located arc-shaped portion and first and second arms extending from each side of the arc-shaped portion, the first arm on each of the angle joint members having a first arm end, the second arm on each of the angle joint members having a second arm end, and each of the first arm ends being connected to a) one of the axial longitudinal members and / or b) one of the frame opening arrangements, and the longitudinal length of one or both of the first and second arms of each of the angle joint members is greater than the width or longitudinal length of the semicircular portion.

44. The artificial heart valve according to any one of claims 34 to 42, wherein each of the angle joint members includes a centrally located arc-shaped portion and first and second arms extending from each side of the arc-shaped portion, the first arm on each of the angle joint members having a first arm end, the second arm on each of the angle joint members having a second arm end, and each of the first arm ends being connected to a) one of the axial longitudinal members and / or b) one of the frame opening arrangements, and the longitudinal length of one or both of the first and second arms of each of the angle joint members is greater than the width or longitudinal length of the semicircular portion.

45. The artificial heart valve according to claim 33, wherein each of the first and second arms includes one to three wavy portions.

46. The artificial heart valve according to any one of claims 34 to 44, wherein each of the first and second arms includes one to three wavy portions.

47. The artificial heart valve according to claim 33, wherein the expandable metal frame is partially or completely formed of a heat-resistant metal alloy, or a metal alloy containing at least 15 awt.% rhenium, or a heat-resistant metal alloy, or a metal alloy containing at least 5 awt.% rhenium, and the metal alloy is not a shape memory alloy.

48. The artificial heart valve according to any one of claims 34 to 46, wherein the expandable metal frame is partially or completely formed of a heat-resistant metal alloy, or a metal alloy containing at least 15 awt.% rhenium, or a heat-resistant metal alloy, or a metal alloy containing at least 5 awt.% rhenium, and the metal alloy is not a shape memory alloy.

49. The artificial heart valve according to claim 33, wherein the expandable metal frame is a) made of a material having reduced rebound when bent such that the expandable frame has a rebound of 5% or less when the expandable metal frame is pressed into a compressed state, b) made of a material having reduced rebound when bent such that the expandable frame has a rebound of 5% or less when the expandable metal frame is expanded from a compressed state to an expanded state, and / or c) the expandable metal frame has a shortening ratio of less than 20% when expanded from the compressed state.

50. The artificial heart valve according to any one of claims 34 to 48, wherein the expandable metal frame is formed of a material having reduced rebound when bent such that the expandable frame has a rebound of 5% or less when the expandable metal frame is compressed into a compressed state, b) formed of a material having reduced rebound when bent such that the expandable frame has a rebound of 5% or less when the expandable metal frame is expanded from a compressed state to an expanded state, and / or c) the expandable metal frame has a shortening ratio of less than 20% when expanded from the compressed state.

51. The artificial heart valve according to claim 33, further comprising a leaflet structure supported by the expandable metal frame, and an inner skirt fixed to the expandable metal frame.

52. An artificial heart valve according to any one of claims 34 to 50, further comprising a leaflet structure supported by the expandable metal frame and an inner skirt fixed to the expandable metal frame.

53. The artificial heart valve according to claim 51, wherein the leaflet structure comprises a plurality of leaflets, each of which has an upper edge portion, a lower edge portion, and two side flaps, each side flap being connected to an adjacent side flap of another leaflet, and at least a portion of the leaflet structure is connected to the expandable metal frame.

54. The artificial heart valve according to claim 52, wherein the leaflet structure comprises a plurality of leaflets, each of which has an upper edge portion, a lower edge portion, and two side flaps, each side flap being connected to an adjacent side flap of another leaflet, and at least a portion of the leaflet structure is connected to the expandable metal frame.

55. The artificial heart valve according to claim 33, further comprising an outer skirt, the outer skirt being fully positioned around a portion of the outer surface of the expandable metal frame, and the outer skirt being connected to the expandable metal frame.

56. The artificial heart valve according to any one of claims 34 to 54, further comprising an outer skirt, the outer skirt being fully positioned around a portion of the outer surface of the expandable metal frame, and the outer skirt being connected to the expandable metal frame.

57. The artificial heart valve according to claim 33, wherein the expandable metal frame is partially or completely formed of a rhenium-containing metal alloy comprising at least 0.1% by weight of rhenium and one or more metals selected from the group consisting of Mo, Cr, Co, Ni, Ti, Ta, Nb, Zr, and W, and the metal alloy is partially or completely formed from metal powders sintered together.

58. The artificial heart valve according to any one of claims 34 to 56, wherein the expandable metal frame is partially or completely formed of a rhenium-containing metal alloy comprising at least 0.1% by weight of rhenium and one or more metals selected from the group consisting of Mo, Cr, Co, Ni, Ti, Ta, Nb, Zr, and W, and the metal alloy is partially or completely formed from metal powders sintered together.

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