Expandable frame for medical devices

Abstract

A prosthetic heart valve is disclosed for use in the treatment of structural heart diseases wherein the prosthetic heart valve comprises an expandable frame formed from a rhenium-containing metal alloy. The novel geometry of the expandable frame, in combination with the frame formed partially or entirely from the rhenium-containing alloy, enables the formation of a frame that: a) has an open mesh geometry in the frame of the prosthetic heart valve, which can be used to reduce delivery system size, and a) has an open mesh geometry in the frame of the prosthetic heart valve, which can be used to reduce delivery system size; the present invention relates to a bioprosthetic valve, b) with high radial strength, c) with improved recovery of physiological EGA, d) with lower backlash, e) without perspective shortening, f) allowing proper placement of the bioprosthetic valve relative to the natural junction of the valve, h) with symmetric and cylindrical expansion of the prosthetic valve, thereby reducing the incidence of leaflet thrombosis and structural valve deterioration, and to a method for manufacturing the same. And i) prevent anaphylaxis and restenosis associated with the nickel content.

Description

[0001] Application for reference

[0002] This application claims priority to U.S. Provisional Application Serial No. 63 / 540,556, filed September 26, 2023, which is incorporated herein by reference. Technical Field

[0003] This disclosure generally relates to medical devices and applications of medical devices, and particularly to medical devices including expandable frames, more particularly to medical devices in the form of cardiovascular implants for treating structural heart disease, wherein the cardiovascular implants include expandable frames, and even more particularly to medical devices in the form of artificial heart valves for treating structural heart disease, wherein the artificial heart valves include expandable frames. Background Technology

[0004] Many cardiovascular devices, such as dilatational heart valves, are inserted into a patient's vascular system and then dilated at the treatment site. These devices are typically coiled onto a catheter before being inserted into the patient.

[0005] Medical devices such as transcatheter aortic valves (TAVs) represent a significant advancement in artificial heart valve technology. TAVs bring the benefits of heart valve replacement to patients who would otherwise not have undergone surgery. Transcatheter aortic valve replacement (TAVR) can be used to treat aortic stenosis in patients classified as high-risk for open-heart surgery aortic valve replacement (SAVR). Non-limiting TAVs are disclosed in U.S. Patent Nos. 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. Publication No. 2020 / 0405482, all of which are incorporated herein by reference in their entirety. The framework material used to form a TAV is typically a TiAlV alloy, a CoCr alloy, or Nitinol™. The vast majority of cardiovascular implants include valves made by constructing a structural framework for the valve using at least CoCr alloys or nickel-titanium materials.

[0006] Transcatheter aortic valves (TAVs) are designed to be compressed into a small-diameter catheter and remotely placed within a patient's diseased aortic valve to take over the function of the original valve. Some TAVs are balloon-expandable, while others are self-expandable. In both cases, the TAV is deployed within a calcified original valve that has been forced open permanently and becomes the surface against which the frame is secured in place by friction. TAVs can also be used to replace failed bioprosthetic or transcatheter valves, often referred to as valve-in-valve procedures. Key advantages of TAVR compared to traditional surgical methods include avoiding cardiopulmonary bypass, aortic clipping, and sternotomy, which significantly reduces patient morbidity.

[0007] However, several complications are associated with current TAV devices, such as severe vascular injury or bleeding due to the large delivery profile, misalignment, leaflet damage due to curling, paravalvular leakage, thrombosis, conduction system abnormalities, and prosthesis-patient mismatch.

[0008] TAVR involves the delivery, deployment, and implantation of a coiled framed valve within a diseased aortic valve or a degenerated bioprosthetic. Current limitations of TAVR include a) vascular complications such as dissection or severe bleeding due to the large size of the delivery system; b) valve frame-related backlash, defined as the frame opening to a certain diameter and then relaxing or stabilizing to a smaller diameter after balloon decompression, which can lead to valvular embolism, paravalvular leak, and reduced effective orifice area (EOA); and c) a high incidence of conduction system damage, which can result in permanent pacemaker implantation or sudden cardiac death. Frame backlash can exacerbate conduction abnormalities, requiring operator intervention during balloon decompression. The following factors contribute to achieving a higher balloon inflation diameter to obtain a physiologically effective orifice area: d) fluoroscopic shortening of the frame during balloon expansion, which may lead to valve misalignment in the aortic annulus; e) imprecise alignment of the TAVR frame commissure with the natural commissure, which can adversely affect hemodynamic performance and prosthetic valve durability; f) uneven valve frame expansion, which can lead to non-cylindrical prosthetic valves, resulting in an increase in acute and chronic complications such as leaflet thrombosis and structural valve deterioration; and g) high nickel content, a common allergen.

[0009] Current structural heart valve surgery is limited by the combination of materials and geometry of the artificial heart valve frame. These limitations 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 traversing calcified anatomy; c) sufficient radial strength to restore the physiological orifice area (EOA) in the diseased valve while maintaining the vascular access diameter; d) frame-associated recoil, defined as the frame opening to a certain diameter and then relaxing or stabilizing to a smaller diameter after balloon deflation, which can lead to valvular embolism, paravalvular leak, and reduced effective orifice area (EOA); e) a high incidence of conduction system damage, which can lead to permanent pacemaker implantation or sudden cardiac death; frame recoil exacerbates conduction abnormalities, requiring the operator to achieve a higher balloon inflation diameter after balloon deflation to obtain the physiological effective orifice area; f) fluoroscopic shortening of the frame during balloon expansion, which can... This can lead to misalignment of the valve within the aortic annulus; g) imprecise alignment of the artificial heart valve frame commissure with the natural commissure, which adversely affects hemodynamic performance, coronary blood flow, and the durability of the artificial valve; h) acute coronary artery obstruction and coronary artery pathway damage due to frame height, commissure misalignment, and misalignment of the open grid geometry at the location of the coronary artery; i) difficulty in late-stage intravalvular intervention due to valve height and / or misalignment of the artificial heart valve frame commissure with the natural commissure, exposing patients to risks of coronary artery obstruction, coronary artery pathway damage, and overlap of open grids, grid sizes, etc.; j) uneven valve frame dilation, which can lead to non-cylindrical artificial valves, resulting in an increase in acute and chronic complications, such as leaflet thrombosis and structural valve deterioration; and k) high nickel content, a common allergen.

[0010] Given the current state of artificial heart valve technology, there is a need for an improved artificial heart valve that addresses the aforementioned shortcomings. Summary of the Invention

[0011] This disclosure relates to medical devices and applications thereof, and particularly to medical devices comprising expandable frames, more particularly to medical devices in the form of cardiovascular implants for treating structural heart disease, wherein the cardiovascular implants include expandable frames, and even more particularly to medical devices in the form of artificial heart valves for treating structural heart disease, wherein the artificial heart valves include expandable frames formed of a rhenium-containing metal alloy. Using a rhenium-containing metal alloy to partially or completely form the frame of the artificial heart valve allows for novel structural artificial heart valve frame geometries. The combination of the rhenium-containing metal alloy and the novel geometry of the artificial heart valve frame addresses the current deficiencies of the artificial heart valves discussed above.Novel geometries for artificial heart valve frames, combined with frames formed partially (e.g., 10 to 99.99% by weight and all values ​​and ranges therein) or entirely of rhenium-containing alloys, enable the formation of frames that a) have an open-grid geometry that can be used to reduce the size of the delivery system, thereby reducing vascular and neurological complications; b) have an open-grid structure that has high radial strength due to the high yield strength and ultimate tensile strength of the rhenium-containing metal alloy; and c) improve the recovery of physiological EOA in challenging, severely calcified valves. Bioartificial valves exert high forces while allowing for a smaller vascular access roll-off diameter, d) improve the recovery of physiological EOA, thereby extending the lifespan of the bioartificial valve, e) have lower recoil than conventional materials used for frame formation such as stainless steel, chromium-cobalt, or titanium alloys, resulting in less frame recoil during expansion, which leads to a reduced risk of valvular embolism, reduced paravalvular leakage due to improved fit to the native anatomy, more precise recovery of physiological EOA, and reduced conduction system damage due to the smaller balloon inflation diameter required to achieve physiological EOA after balloon inflation. f) It has an open grid geometry configured to have very little (e.g., 0 to 20% fluoroscopic shortening and all values ​​and ranges therein) or no fluoroscopic shortening during expansion. This allows for more precise placement of the valve within the native valve annulus, and a frame with little or no fluoroscopic shortening during expansion can be expanded with a shorter balloon. Using a shorter balloon for frame expansion reduces conduction system damage. g) It has commissure alignment marks and an open grid between commissures. This allows for proper placement of the bioartificial valve relative to the valve's native commissure to facilitate flushing of the valve. And proper hemodynamic function of blood flow to the coronary arteries, which leads to better valve durability and lifespan, as well as accessibility and re-intervention of the coronary arteries, thereby preventing future adverse events; h) having an open mesh geometry with radial symmetry, longitudinal symmetry, and little or no fluoroscopic shortening, which allows for symmetrical and cylindrical expansion of the prosthetic valve, resulting in a lower rate of leaflet thrombosis and structural valve degeneration; and i) being formed of a rhenium-containing metal alloy without nickel content, which prevents allergic reactions due to the presence of nickel and restenosis associated with nickel content.

[0012] In one non-limiting aspect of this disclosure, an artificial heart valve (e.g., a heart valve, a TAVR valve, a mitral valve replacement, a tricuspid valve replacement, a pulmonary valve replacement, etc.) includes a radially collapsible and expandable frame and a leaflet structure comprising multiple leaflets. In another non-limiting embodiment, the artificial heart valve optionally includes an annular skirt or covering member disposed on at least a portion of the grid of the frame and partially or completely covering or over at least a portion of the grid of the frame. In yet another non-limiting embodiment, the frame of the artificial heart valve includes a plurality of interconnected axial longitudinal members, angular hinge members, and strut joints that define a plurality of open grids within the frame.

[0013] In another and / or alternative non-limiting aspect of this disclosure, the framework of the artificial heart valve is optionally formed, in part or entirely, of a) a refractory metal alloy and / or b) a metal alloy comprising at least 15 atomic weight percent (AJ%) or atomic weight percent (AJ%) rhenium, in order to produce a “rhenium effect” in the metal alloy. As used herein, atomic weight percent (AJ%) or atomic percentage (AJ%) is used interchangeably. As defined herein, a weight percent (wt%) of an element is the weight of that element measured in a sample divided by the weight of all elements in the sample multiplied by 100. An atomic percentage or atomic weight percent (AJ%) is the number of atoms of that element at that weight percent divided by the total number of atoms in the sample multiplied by 100. The use of the terms weight percent (wt%) and atomic percentage or atomic weight percent (AJ%) refers to two ways of referring to metal alloys and their composition. It has been found that for several metal alloys, the presence of at least 15 atomic weight percent rhenium improves both the ductility and / or tensile strength of these alloys compared to rhenium-free alloys. The improvement in ductility and / or tensile strength resulting from the presence of at least 15 atomic weight percent 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 the ductility of a metal alloy due to the addition of rhenium and / or b) an increase of at least 10% in the tensile strength of a metal alloy due to the addition of rhenium. As defined herein, a refractory metal alloy is a metal alloy containing at least 20 wt% of one or more of molybdenum, rhenium, niobium, tantalum, or tungsten. Non-limiting refractory metal alloys include MoRe alloys, ReW alloys, MoReCr alloys, MoReTa alloys, MoReTi alloys, WCu alloys, ReCr, molybdenum alloys, rhenium alloys, tungsten alloys, tantalum alloys, niobium alloys, etc. In one non-limiting arrangement, 50 to 100% by weight (and all values ​​and ranges therebetween) of the expandable frame of the artificial heart valve is formed of a refractory metal alloy or a metal alloy containing at least 15 atomic weights of rhenium. In another non-limiting arrangement, the metal alloy used to partially or completely form the expandable frame of the artificial heart valve contains at least 30% by weight (e.g., 30 to 99% by weight and all values ​​and ranges therebetween) of one or more of molybdenum, rhenium, niobium, tantalum, or tungsten.In another non-limiting embodiment, a refractory metal alloy or a metal alloy containing at least 15 atomic weight percent rhenium can be used to 1) improve the radiation impermeability of the artificial heart valve frame, 2) improve the radial strength of the artificial heart valve frame, 3) improve the yield strength and / or ultimate tensile strength of the artificial heart valve frame, 4) improve the stress-strain characteristics of the artificial heart valve frame, 5) improve the curling and / or expansion characteristics of the artificial heart valve frame, 6) improve the bending and / or flexibility of the artificial heart valve frame, 7) improve the strength and / or durability of the artificial heart valve frame, 8) improve the stiffness of the artificial heart valve frame, 9) improve the biocompatibility and / or biostability of the artificial heart valve frame, 10) improve the fatigue resistance of the artificial heart valve frame, 11) resist cracking in the artificial heart valve frame, 12) resist the propagation of cracks in the artificial heart valve frame, and 13) enable the fabrication of smaller, thinner, and / or lighter artificial heart valves. The artificial heart valve frame, 14) promotes the reduction of the outer diameter of the coiled artificial heart valve, 15) improves the fit of the artificial heart valve frame to the shape of the treatment area when the artificial heart valve expands in the treatment area, 16) reduces the recoil of the artificial heart valve frame after expansion in the treatment area, 17) reduces adverse tissue reactions caused by the artificial heart valve frame, 18) reduces the release of metal ions from the frame after artificial heart valve implantation, 19) reduces the corrosion of the artificial heart valve frame after implantation, 20) reduces allergic reactions caused by the artificial heart valve frame after implantation (e.g., reducing the nickel content of the metal alloy), 21) increases the hydrophilicity of the artificial heart valve frame, 22) reduces the magnetization of the artificial heart valve frame, 23) reduces the fluoroscopic shortening of the artificial heart valve frame when it expands, and / or 24) reduces the toxicity of the artificial heart valve frame after implantation.

[0014] In another and / or alternative non-limiting aspect of this disclosure, the framework of the artificial heart valve is optionally formed in part or in whole from 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, the framework of which has been modified to contain at least 15 atomic weight percent rhenium in order to result in improved ductility and / or tensile strength compared to the same metal alloy without rhenium. As defined herein, a standard stainless steel alloy (SS alloy) comprises 10 to 28 wt% chromium, 0 to 35 wt% nickel, 0 to 4 wt% molybdenum, 0 to 2 wt% manganese, 0 to 0.75 wt% silicon, 0 to 0.3 wt% carbon, 0 to 5 wt% titanium, 0 to 10 wt% niobium, 0 to 5 wt% copper, 0 to 4 wt% aluminum, 0 to 10 wt% tantalum, 0 to 1 wt% selenium, 0 to 2 wt% vanadium, 0 to 2 wt% tungsten, and at least 50 wt% iron. The standard 316L alloy, which is a standard stainless steel alloy, comprises 17 to 19 wt% chromium, 13 to 15 wt% nickel, 2 to 4 wt% molybdenum, up to 2 wt% manganese, up to 0.75 wt% silicon, up to 0.03 wt% carbon, and the balance iron. As defined herein, a standard cobalt-chromium alloy (CoCr alloy) comprises 15 to 32 wt% chromium, 1 to 38 wt% nickel, 2 to 18 wt% molybdenum, 0 to 18 wt% iron, 0 to 1 wt% titanium, 0 to 0.15 wt% manganese, 0 to 0.15 wt% silver, 0 to 0.25 wt% carbon, 0 to 16 wt% tungsten, 0 to 2 wt% silicon, 0 to 2 wt% aluminum, 0 to 1 wt% iron, 30 to 68 wt% cobalt, 0 to 0.1 wt% boron, 0 to 0.15 wt% silver, and 0 to 2 wt% titanium. Standard MP35N alloy, a standard CoCr alloy, contains 18 to 22 wt% chromium, 32 to 38 wt% nickel, 8 to 12 wt% molybdenum, 0 to 2 wt% iron, 0 to 0.5 wt% silicon, 0 to 0.5 wt% manganese, 0 to 0.2 wt% carbon, 0 to 2 wt% titanium, 0 to 0.1 wt% boron, 0 to 0.15 wt% silver, and the balance cobalt. Standard Phynox and Standard Elgiloy alloys, as defined herein, contain 38 to 42 wt% cobalt, 18 to 22 wt% chromium, 14 to 18 wt% iron, 13 to 17 wt% nickel, and 6 to 8 wt% molybdenum. Standard L605 alloy, as defined herein, contains 18 to 22 wt% chromium, 14 to 16 wt% tungsten, 9 to 11 wt% nickel, and the balance cobalt. As defined herein, a standard titanium-aluminum-vanadium alloy (TiAlV alloy) contains 5.5 to 6.75 wt% aluminum, 3.5 to 4.5 wt% vanadium, 85 to 93 wt% titanium, 0 to 0.4 wt% iron, and 0 to 0.2 wt% carbon.The standard Ti-6Al-4V alloy, which belongs to the standard TiAlV alloy, contains 3.5 to 4.5 wt% vanadium, 5.5 to 6.75 wt% aluminum, up to 0.3 wt% iron, up to 0.08 wt% carbon, up to 0.05 wt% yttrium, and the balance titanium. As defined herein, a standard aluminum alloy comprises 80 to 99 wt% aluminum, 0 to 12 wt% silicon, 0 to 5 wt% magnesium, 0 to 1 wt% manganese, 0 to 0.5 wt% scandium, 0 to 0.5 wt% beryllium, 0 to 0.5 wt% yttrium, 0 to 0.5 wt% cerium, 0 to 0.5 wt% chromium, 0 to 3 wt% iron, 0 to 0.5 wt% zinc, 0 to 0.5 wt% titanium, 0 to 3 wt% lithium, 0 to 0.5 wt% silver, 0 to 0.5 wt% calcium, 0 to 0.5 wt% zirconium, 0 to 1 wt% lead, 0 to 0.5 wt% cadmium, 0 to 0.05 wt% bismuth, 0 to 1 wt% nickel, 0 to 0.2 wt% vanadium, 0 to 0.1 wt% gallium, and 0 to 7 wt% copper. As defined herein, a standard nickel alloy comprises 30 to 98 wt% nickel, 5 to 25 wt% chromium, 0 to 65 wt% iron, 0 to 30 wt% molybdenum, 0 to 32 wt% copper, 0 to 32 wt% cobalt, 2 to 2 wt% aluminum, 0 to 6 wt% tantalum, 0 to 15 wt% tungsten, 0 to 5 wt% titanium, 0 to 6 wt% niobium, and 0 to 3 wt% silicon. As defined herein, a standard titanium alloy comprises 80 to 99 wt% titanium, 0 to 6 wt% aluminum, 0 to 3 wt% tin, 0 to 1 wt% palladium, 0 to 8 wt% vanadium, 0 to 15 wt% molybdenum, 0 to 1 wt% nickel, 0 to 0.3 wt% ruthenium, 0 to 6 wt% chromium, 0 to 4 wt% zirconium, 0 to 4 wt% niobium, 0 to 1 wt% silicon, 0.05 wt% cobalt, and 0 to 2 wt% iron. As defined herein, a standard tungsten alloy comprises 85 to 98 wt% tungsten, 0 to 8 wt% nickel, 0 to 5 wt% copper, 0 to 5 wt% molybdenum, and 0 to 4 wt% iron. As defined herein, a standard molybdenum alloy comprises 90 to 99.5 wt% molybdenum, 0 to 1 wt% nickel, 0 to 1 wt% titanium, 0 to 1 wt% zirconium, 0 to 30 wt% tungsten, 0 to 2 wt% hafnium, and 0 to 2 wt% lanthanum. As defined herein, a standard copper alloy comprises 55 to 95 wt% copper, 0 to 40 wt% zinc, 0 to 10 wt% tin, 0 to 10 wt% lead, 0 to 1 wt% iron, 0 to 5 wt% silicon, 0 to 12 wt% manganese, 0 to 12 wt% aluminum, 0 to 3 wt% beryllium, 0 to 1 wt% cobalt, and 0 to 20 wt% nickel. As defined herein, standard beryllium-copper alloys comprise 95 to 98.5 wt% copper, 1 to 4 wt% beryllium, 0 to 1 wt% cobalt, and 0 to 0.5 wt% silicon. As defined herein, standard titanium-nickel alloys (e.g., nickel-titanium alloys) comprise 42 to 58 wt% nickel and 42 to 58 wt% titanium. The rhenium effect has been observed when the atomic weight of rhenium in a metallic alloy is at least 15% (e.g., 15 to 99 atomic weights of rhenium in a metallic alloy and all values ​​and ranges therebetween).For example, for standard stainless steel alloys, the rhenium effect can begin to appear when the stainless steel alloy is modified to include at least 5 to 10 wt% (and all values ​​and ranges therebetween) rhenium of the stainless steel alloy. For standard CoCr alloys, the rhenium effect can begin to appear when the CoCr alloy is modified to include at least 4.8 to 9.5 wt% (and all values ​​and ranges therebetween) rhenium of the CoCr alloy. For standard TiAlV alloys, the rhenium effect can begin to appear when the TiAlV alloy is modified to include at least 4.5 to 9 wt% (and all values ​​and ranges therebetween) rhenium of the TiAlV alloy. It is understood that the rhenium content in the above non-limiting examples can be greater than the minimum amount required to produce the rhenium effect in the metal alloy.

[0015] According to another and / or alternative aspect of this disclosure, the metal alloy used to partially or completely form the framework of an artificial heart valve comprises at least 5 atomic weight percent (e.g., 5 to 99 atomic weight percent and all values ​​and ranges therebetween) rhenium and at least 0.1 to 96 wt percent (and all values ​​and ranges therebetween) one or more additives selected from the group consisting of: 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, palladium, platinum, rare earth metals, rhodium, ruthenium, scandium, silver, silicon, tantalum, technetium, tin, titanium, tungsten, vanadium, yttrium, zinc and / or zirconium, and the metal alloy optionally comprises 0 to 2 wt percent (and all values ​​and ranges therebetween) of other metals (e.g., metals other than additives), carbon, oxygen, phosphorus, sulfur, hydrogen and / or nitrogen, and the metal alloy exhibits a rhenium effect. In one non-limiting embodiment, the frame for partially or completely forming an artificial heart valve is a standard stainless steel alloy modified to contain at least 15 atomic weight percent rhenium. In another non-limiting embodiment, the frame for partially or completely forming an artificial heart valve is a standard cobalt-chromium alloy modified to contain at least 15 atomic weight percent rhenium. In another non-limiting embodiment, the frame for partially or completely forming an artificial heart valve is a standard TiAlV alloy modified to contain at least 15 atomic weight percent rhenium. In another non-limiting embodiment, the frame for partially or completely forming an artificial heart valve is a standard aluminum alloy modified to contain at least 15 atomic weight percent rhenium. In another non-limiting embodiment, the frame for partially or completely forming an artificial heart valve is a standard nickel alloy modified to contain at least 15 atomic weight percent rhenium. In another non-limiting embodiment, the frame for partially or completely forming an artificial heart valve is a standard titanium alloy modified to contain at least 15 atomic weight percent rhenium. In another non-limiting embodiment, the frame for partially or completely forming the artificial heart valve is a standard tungsten alloy modified to contain at least 15 atomic weight percent rhenium. In another non-limiting embodiment, the frame for partially or completely forming the artificial heart valve is a standard molybdenum alloy modified to contain at least 15 atomic weight percent rhenium. In another non-limiting embodiment, the frame for partially or completely forming the artificial heart valve is a standard copper alloy modified to contain at least 15 atomic weight percent rhenium. In another non-limiting embodiment, the frame for partially or completely forming the artificial heart valve is a standard beryllium-copper alloy modified to contain at least 15 atomic weight percent rhenium.

[0016] According to another and / or alternative aspect of this disclosure, the metal alloy used to partially or completely form the framework of the artificial heart valve comprises rhenium and molybdenum, and the weight percentage of rhenium in the metal alloy is optionally greater than the weight percentage of molybdenum in the metal alloy, and the weight percentage of one or more additives in the metal alloy (e.g., 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, 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 contains 0 to 2% by weight of other metals (metals other than additives), carbon, oxygen, phosphorus, sulfur, hydrogen and / or nitrogen combinations. In a non-limiting embodiment, the metal alloy used to partially or completely form the framework of the artificial heart valve comprises rhenium and molybdenum, and the weight percentage of rhenium plus the combined weight percentage of additives is greater than the weight percentage of molybdenum, and the metal alloy optionally comprises 0 to 2% by weight of other metals (metals other than additives), carbon, oxygen, phosphorus, sulfur, hydrogen and / or nitrogen combinations.

[0017] According to another and / or alternative aspect of this disclosure, the metal alloy used to partially or completely form the framework of the artificial heart valve comprises rhenium and molybdenum, and the atomic weight percentage of rhenium is in the ratio of the atomic weight percentage of one or more of bismuth, niobium, tantalum, tungsten, titanium, vanadium, chromium, manganese, yttrium, zirconium, technetium, ruthenium, rhodium, hafnium, osmium, copper and iridium to 0.4:1 to 2.5:1 (and all values ​​and ranges therebetween).

[0018] According to another and / or alternative aspect of this disclosure, the metal alloy used to partially or completely form the framework of an artificial heart valve comprises at least 5 atomic weight percent (e.g., 5 to 99 atomic weight percent and all values ​​and ranges therebetween) of rhenium plus at least two metals selected from the group consisting of molybdenum, bismuth, chromium, iridium, niobium, tantalum, titanium, yttrium, and zirconium, and the metal alloy comprising other elements and compounds is present in a content of 0 to 0.1 wt%. 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 percent (e.g., 35 to 75 wt percent and all values ​​and ranges therebetween) of rhenium, and the metal alloy also comprises chromium. In a non-limiting embodiment, the metal alloy comprises at least 35% by weight rhenium, and at least 25% by weight (e.g., 25 to 49.9% by weight and all values ​​and ranges therebetween) of the metal alloy comprises chromium, and optionally 0.1 to 40% by weight (and all values ​​and ranges therebetween) of the metal alloy comprises one or more of the following: 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, palladium, platinum, rare earth metals, rhodium, ruthenium, scandium, silver, silicon, tantalum, technetium, tin, titanium, tungsten, vanadium, yttrium, zinc and / or zirconium, and the metal alloy optionally comprises 0 to 2% by weight (and all values ​​and ranges therebetween) of other metals, carbon, oxygen, phosphorus, sulfur, hydrogen and / or nitrogen combinations. In another non-limiting embodiment, the metal alloy comprises 15 to 50 atomic weight % rhenium (and all values ​​and ranges therebetween) and 0.5 to 70 atomic weight % chromium (and all values ​​and ranges therebetween). In another non-limiting embodiment, the metal alloy comprises 15 to 50 atomic weight % rhenium (and all values ​​and ranges therebetween) and 0.5 to 70 atomic weight % tantalum (and all values ​​and ranges therebetween). In another non-limiting embodiment, the metal alloy comprises 15 to 50 atomic weight % rhenium (and all values ​​and ranges therebetween) and 0.5 to 70 atomic weight % niobium (and all values ​​and ranges therebetween). In another non-limiting embodiment, the metal alloy comprises 15 to 50 atomic weight % rhenium (and all values ​​and ranges therebetween) and 0.5 to 70 atomic weight % titanium (and all values ​​and ranges therebetween). In another non-limiting embodiment, the metal alloy comprises 15 to 50 atomic weight % rhenium (and all values ​​and ranges therebetween) and 0.5 to 70 atomic weight % zirconium (and all values ​​and ranges therebetween). In another non-limiting embodiment, the metal alloy comprises 15 to 50 atomic weight % rhenium (and all values ​​and ranges therebetween) and 0.5 to 70 atomic weight % molybdenum (and all values ​​and ranges therebetween).In another non-limiting embodiment, the metal alloy comprises at least 15 atomic weight percent rhenium, greater than 50 wt percent titanium (e.g., 51 to 80 wt percent and all values ​​and ranges therebetween), 15 to 45 wt percent niobium (and all values ​​and ranges therebetween), 0 to 10 wt percent zirconium (and all values ​​and ranges therebetween), 0 to 15 wt percent tantalum (and all values ​​and ranges therebetween), and 0 to 8 wt percent molybdenum (and all values ​​and ranges therebetween).

[0019] The following are some non-limiting examples of metallic alloys that can be used to partially or completely form orthopedic medical devices, described in weight percentage: Components / 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% Components / weight % 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% Components / 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% Components / 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% Components / 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% Components / 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 Components / 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 Components / 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% 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% Ag 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% Ni 0-25% 0-25% 0-25% 0-25% Pt 0-25% 0-25% 0-25% 0-25% Si 0-25% 0-25% 0-25% 0-25% Sn 0-25% 0-25% 0-25% 0-25% Components / 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% Components / 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% Components / 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% Components / 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% Components / 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% Components / 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% Components / 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% Components / 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% Components / 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% Ir 0-10% 0-10% 0-10% 0-10% La 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% Mo 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% Se 0-10% 0-10% 0-10% 0-10% Si 0-10% 0-10% 0-10% 0-10% Sn 0-10% 0-10% 0-12% 0-12% Ta 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% Components / 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% Components / 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% Components / Weight % Example 73 Example 74 Example 75 Example 76 Ag 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% Ta 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% Components / Weight % Example 77 Example 78 Example 79 Example 80 Ag 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% Components / 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% Day 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 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% Tea 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% Components / 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% 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 1-15% 2-10% 3-8% 0-5% Nb 0-5% 0-5% 0-5% 20-45% 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% 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% Components / 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% Components / 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% Components / 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% Components / 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% In Examples 1 through 108, it should be understood that all the above ranges include any value between that range and any other range set forth above. Any of the above values ​​including the ≤ sign includes the range from 0 to the specified value, and all values ​​and ranges in between.

[0020] In another and / or alternative non-limiting aspect of this disclosure, the metal alloy used to partially or completely form the framework of the artificial heart valve contains less than about 5% by weight (e.g., 0% to 4.999999% by weight and all values ​​and ranges therebetween) of other metals and / or impurities, typically 0% to 1% by weight, more typically 0% to 0.1% by weight, even more typically 0% to 0.01% by weight, and even more typically 0% to 0.001% by weight. High levels of purity in the metal alloy can result in a more homogeneous alloy, which in turn can lead to a more uniform density throughout the metal alloy, and can also result in the desired yield strength and ultimate tensile strength of the metal alloy.

[0021] According to another and / or alternative aspect of this disclosure, the frame for the artificial heart valve optionally undergoes one or more manufacturing processes. These manufacturing processes may include, but are not limited to, expansion, laser cutting, etching, curling, annealing, drawing, Pilger rolling, electroplating, electropolishing, machining, plasma coating, 3D printing coating, chemical vapor deposition, chemical polishing, cleaning, pickling, ion beam deposition or implantation, sputtering coating, vacuum deposition, etc.

[0022] According to another and / or alternative aspect of this disclosure, the metal alloy optionally contains specific amounts of carbon and oxygen; however, this is not required. Both elements have been found to affect the formability and brittleness of the metal alloy. A controlled atomic ratio of carbon to oxygen in the metal alloy also minimizes the tendency for the metal alloy to form microcracks during the formation of the framework for an artificial heart valve and / or during in vivo use and / or expansion of the framework for the artificial heart valve. 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 therebetween). In a non-limiting formulation, the carbon to oxygen atomic ratio in the metal alloy is typically at least about 0.3:1. Typically, the carbon content of the metal alloy is less than about 0.1 wt% (e.g., 0 wt% to 0.0999999 wt% and all values ​​and ranges therebetween), and more typically 0 wt% to 0.01 wt%. Excessive carbon content can adversely affect the physical properties of the metal alloy. Generally, the oxygen content should be maintained at a very low level. In a non-limiting formulation, the oxygen content is less than about 0.1 wt% of the metal alloy (e.g., 0 wt% to 0.0999999 wt% and all values ​​and ranges therebetween), and typically 0 wt% to 0.01 wt%.

[0023] According to another and / or alternative aspect of this disclosure, the metal alloy optionally contains a controlled amount of nitrogen; however, this is not required. A large amount of nitrogen in the metal alloy may adversely affect its ductility. This, in turn, may adversely affect its elongation properties. In one non-limiting formulation, the metal alloy contains less than about 0.001% by weight of nitrogen (e.g., 0% by weight to 0.0009999% by weight and all values ​​and ranges therebetween). It should be believed that the nitrogen content should 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 therebetween). 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 therebetween).

[0024] According to another and / or alternative aspect of this disclosure, the metal alloy used to form all or part of the framework for an artificial heart valve 1) is not clad, metal-coated, metal-sprayed, plated, and / or formed (e.g., cold-worked, hot-worked, etc.) on another metal or 2) is not metal-sprayed, metal-coated, plated, clad, and / or formed on the metal alloy. It should be understood that in some applications, the metal alloy of this disclosure may be clad, metal-sprayed, metal-coated, plated, and / or formed on another metal, or when forming all or part of the framework for an artificial heart valve, another metal or metal alloy may be plated, metal-sprayed, metal-coated, clad, and / or formed on the metal alloy.

[0025] According to another and / or alternative aspect of this disclosure, metal alloys can be used to form a coating (e.g., a covering, dip coating, spray coating, plating, weld coating, plasma coating, etc.) on a portion or all of the frame for an artificial heart valve or b) the core of the frame for an artificial heart valve. The composition of the coating may differ 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 therein). In one non-limiting example, a frame for an artificial heart valve is provided, wherein the core or base layer of the frame for the artificial heart valve is formed of a metal or metal alloy (e.g., chromium alloy, titanium, titanium alloy, stainless steel, ferroalloy, CoCr alloy, rhenium alloy, molybdenum alloy, tungsten alloy, Ta-W alloy, refractory metal alloy, MoTa alloy, MoRe alloy, etc.) or polymer or ceramic or composite material, and another layer of the coated frame for the artificial heart valve is formed of a different metal or metal alloy. The core or base layer and another layer of the frame for an artificial heart valve may each form 10 to 99% (and all values ​​and ranges therebetween) of the entire cross-section of the frame for the artificial heart valve. When the outer metal coating is a rhenium-containing alloy, such an alloy can be used to create a hard surface at specific locations and across the entire surface of the frame for the artificial heart valve. In another non-limiting embodiment, the core or base layer of the frame for the artificial heart valve may be formed of a rhenium-containing alloy, and the coating may comprise one or more other materials (e.g., another type of metal or metal alloy [e.g., chromium alloys, titanium, titanium alloys, stainless steel, ferroalloys, CoCr alloys, rhenium alloys, molybdenum alloys, tungsten alloys, Ta-W alloys, refractory metal alloys, MoTa alloys, MoRe alloys, etc.), polymer coatings, ceramic coatings, composite material coatings, etc.). Non-limiting benefits of using rhenium-containing alloys in the core or inner layer of the frame for an artificial heart valve may include reducing the size of the frame for the artificial heart valve, increasing the strength of the frame for the artificial heart valve, and / or maintaining or reducing the cost of the frame for the artificial heart valve. As can be understood, the use of rhenium-containing alloys may provide other or additional advantages. The core or base layer dimensions and / or thickness of the metal alloy are not limited. In one non-limiting example, a framework for an artificial heart valve is provided, which is at least partially formed of a layered material, wherein the top layer is formed of a material different from one or more other layers, and a rhenium-containing alloy forms one of the layers below the top layer, and the top layer is formed of a metal different from the rhenium-containing alloy (e.g., chromium alloy, titanium, titanium alloy, stainless steel, ferroalloy, CoCr alloy, rhenium alloy, molybdenum alloy, tungsten alloy, Ta-W alloy, refractory metal alloy, MoTa alloy, MoRe alloy, etc.). The core and lower or base and outer layers of the layered material may each form 10 to 99% (and all values ​​and ranges therebetween) of the entire cross-section of the layered material.

[0026] In another and / or alternative non-limiting embodiment of this disclosure, the average tensile elongation of the metal alloy used to at least partially form the framework for the artificial heart valve is optionally at least about 20% (e.g., 20% to 50% average tensile elongation and all values ​​and ranges therebetween). An average tensile elongation of at least 20% of the metal alloy can be used to facilitate the proper expansion of the framework for the artificial heart valve when positioned in the therapeutic area of ​​the body. The desired tensile elongation can be achieved through a unique combination of metals in the metal alloy to achieve the desired purity and composition of the alloy, as well as the desired grain size of the metal alloy.

[0027] According to another and / or alternative aspect of this disclosure, the metal alloy is optionally formed at least partially by a die forging process; however, this is not required. In a non-limiting embodiment, the metal alloy is die forged to at least partially or completely achieve the final dimensions of one or more portions of the frame for an artificial heart valve. The die forging die may be shaped to fit the final dimensions of the frame for the artificial heart valve; however, this is not required.

[0028] According to another and / or alternative aspect of this disclosure, the metal alloy may optionally be nitrided; however, this is not required. When partially or completely forming a framework for an artificial heart valve, the nitrided layer on the metal alloy may act as a lubricating surface during optional drawing of the metal alloy.

[0029] According to another and / or alternative non-limiting aspect of this disclosure, the frame for an artificial heart valve may optionally be partially (e.g., 1% to 99.99% and all values ​​and ranges therein) or completely coated with and / or include one or more pharmaceutical agents. When one or more pharmaceutical agents are coated on the artificial heart valve and the artificial heart valve includes a reinforcing coating, the one or more pharmaceutical agents are typically coated on the outer surface of the reinforcing coating. The term "pharmaceutical agent" includes, but is not limited to, substances, pharmaceuticals, biological products, veterinary products, medicines, and analogues or derivatives otherwise formulated and / or designed to prevent, inhibit, and / or treat one or more clinical and / or biological events and / or to promote healing. Non-limiting examples of clinical events that can be resolved by one or more pharmaceutical agents include, but are not limited to, viral, fungal and / or bacterial infections; vascular diseases and / or disorders; lymphatic diseases and / or disorders; cancer; implant rejection; pain; nausea; swelling; organ failure; immune diseases and / or disorders; cell growth inhibitors; blood diseases and / or disorders; heart diseases and / or disorders; neuralgia diseases and / or disorders; fatigue; genetic diseases and / or disorders; trauma; cramps; muscle spasms; tissue repair; nerve repair; nerve regeneration, etc.

[0030] The type and / or amount of the pharmaceutical agent coated on the frame for an artificial heart valve can vary. According to another and / or alternative aspect of this disclosure, one or more portions of the frame for an artificial heart valve may optionally 1) include the same or different pharmaceutical agents, 2) include one or more pharmaceutical agents in the same or different amounts, 3) include the same or different polymer coatings, 4) include one or more polymer coatings with the same or different coating thicknesses, 5) allow controlled and / or uncontrolled release of one or more pharmaceutical agents from one or more portions of the frame for an artificial heart valve, and / or 6) allow controlled release of one or more pharmaceutical agents from one or more portions of the frame for an artificial heart valve, and uncontrolled release of one or more pharmaceutical agents from one or more portions of the frame for an artificial heart valve.

[0031] According to another and / or alternative aspect of this disclosure, one or more surfaces of the frame for an artificial heart valve may optionally be treated to achieve desired coating properties of one or more pharmaceutical agents and / or one or more polymers applied to the frame for the artificial heart valve. Such surface treatment techniques include, but are not limited to, cleaning, polishing, smoothing, nitriding, annealing, forging, cold working, etching (chemical etching, plasma etching, etc.), etc. As will be understood, other or additional surface treatment processes may be used prior to coating the surface of the frame for the artificial heart valve with one or more pharmaceutical agents and / or polymers.

[0032] In another and / or alternative non-limiting aspect of this disclosure, the frame for the artificial heart valve may optionally include a marking material that facilitates proper positioning of the frame for the artificial heart valve within a body channel. The marking material is typically designed to be visible to: electromagnetic waves (e.g., X-rays, microwaves, visible light, infrared waves, ultraviolet waves, etc.); acoustic waves (e.g., ultrasound waves, etc.); magnetic waves (e.g., MRI waves, 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 for an artificial heart valve or one or more regions of the frame for an artificial heart valve may optionally be constructed using one or more microelectromechanical manufacturing (MEMS) techniques (e.g., micromachining, laser micromachining, microforming, etc.); however, other or additional manufacturing techniques may be used.

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

[0035] According to another and / or alternative aspect of this disclosure, the frame for an artificial heart valve may optionally include one or more microstructures (e.g., microneedles, micropores, micropillars, microcones, micropyramids, microtubes, microparallelograms, microprisms, microhemispheres, teeth, ribs, spines, ratchet wheels, hinges, zippers, zipper-like structures, etc.) located on the surface of the frame for the artificial heart valve. As defined herein, a “microstructure” is a structure having at least one dimension (e.g., average width, average diameter, average height, average length, average depth, etc.) not exceeding about 2 mm and generally not exceeding about 1 mm.

[0036] In another and / or alternative aspect of this disclosure, the frame for the artificial heart valve may optionally be an expandable device that can be expanded using some other means (e.g., a balloon, etc.). The frame for the artificial heart valve may be made of a material that does not have or substantially does not have shape memory properties.

[0037] According to another and / or alternative aspect of this disclosure, a near-net-shape process for a frame for use in artificial heart valves is optionally provided. In a non-limiting embodiment of this disclosure, a method is provided to increase the post-sintering strength of a powder-pressed material by imparting additional cold working. In one non-limiting embodiment, a green blank is pressed and then sintered. Subsequently, the sintered blank is pressed again to increase its mechanical strength by imparting cold working to the pressed and sintered blank.

[0038] According to another and / or alternative aspect of this disclosure, the metal alloy used to at least partially form the framework for an artificial heart valve can optionally be initially formed as a billet, rod, tube, etc., and then finished into its final form by one or more finishing processes. The metal alloy billet, rod, tube, etc., can be formed by various techniques, such as, but not limited to, 1) melting the metal alloy and / or the metal forming the metal alloy (e.g., vacuum arc melting, etc.), and then extruding and / or casting the metal alloy into a billet, 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 billet, rod, tube, etc.; 3) solidifying the metal powder of the metal alloy and / or the metal powder forming the metal alloy into a billet, rod, tube, etc.; or 4) 3D printing the metal powder of the metal alloy and / or the metal powder forming the metal alloy to form the metal alloy into a billet, rod, tube, etc. When the metal alloy is formed as a billet, the shape and size of the billet are not limited.

[0039] According to another and / or alternative aspect of this disclosure, when metal powders are consolidated to form a metal alloy into a billet, rod, tube, etc., the metal powders are pressed together to form a solid solution of the metal alloy into a near-net-shape frame for an artificial heart valve, a near-net-shape component of the frame for an artificial heart valve, a billet, rod, tube, etc. Typically, the pressing process is performed by isostatic pressing (i.e., applying uniform pressure to the metal powder from all sides); however, other processes may be used. When metal powders are pressed together in an isostatic manner, cold isostatic pressing (CIP) is typically used to consolidate the metal powders; however, this is not necessary. The pressing process can be performed in an inert atmosphere, an oxygen-reducing atmosphere (e.g., a mixture of hydrogen, argon, and hydrogen, etc.) and / or under vacuum; however, this is not necessary.

[0040] According to another and / or alternative aspect of this disclosure, when metal powder is used for 3D printing of frames for artificial heart valves, components of frames for artificial heart valves, blanks, rods, tubes, etc., the average particle size of the metal powder is optionally 2-62 micrometers, and more particularly about 5-49.9 micrometers, the average density of the metal powder is greater than 5 g / cm3, and the metal powder is generally spherical, and the Hall flow rate (s / 50 g) is less than 30 seconds (e.g., 2-29.99 seconds and all values ​​and ranges therebetween).

[0041] According to another and / or alternative non-limiting aspect of this disclosure, the frame for an artificial heart valve may be partially (e.g., 1% to 99.99% and all values ​​and ranges therein) or completely coated with a reinforcing coating to improve one or more properties of the frame for the artificial heart valve (e.g., changing the external color of the material having the coated surface, increasing surface hardness by using the coated surface, increasing the surface toughness of the material having the coated surface, reducing friction by using the coated surface, improving the scratch resistance of the material having the coated surface, improving the impact wear of the coated surface, improving the corrosion resistance and oxidation resistance of the coated material, forming a non-stick coated surface, improving the biocompatibility of the material having the coated surface, reducing the toxicity of the material having the coated surface, reducing the ion release of the material having the coated surface, and the reinforcing coating forming a less cellularly irritating surface around the coated surface after implantation of the frame for the artificial heart valve). Non-limiting reinforcing coatings that can be applied to a portion or all of the outer surface of a frame for an artificial heart valve include chromium nitride (CrN), diamond-like carbon (DLC), titanium nitride (TiN), titanium oxynitride (TiNOx), zirconium nitride (ZrN), zirconium oxide (ZrO2), zirconium carbide nitride (ZrNC), zirconium carbide oxycarbonide (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 a portion or all of the outer surface of the frame for an artificial heart valve via a vacuum process that uses energy to evaporate the material and deposit a thin layer of reinforcing coating material. When used, such vacuum coating processes may include physical vapor deposition (PVD) processes (e.g., sputtering deposition, cathodic 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 occurs at a temperature of 200-400°C (and all values ​​and ranges therebetween) for at least 10 minutes (e.g., 10-400 minutes and all values ​​and ranges therebetween). In another non-limiting embodiment, the coating process is one or more of PVD, CVD, ALD, and PE-CVD, and the coating process is performed at a temperature of 220-300°C for 60-120 minutes.In another non-limiting embodiment, when one or more reinforcing coating materials are applied to the outer surface of a framework for an artificial heart valve that is partially or entirely formed of a metal alloy, the 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 in the metal alloy and / or present in the atmosphere surrounding 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 a framework for an artificial heart valve that is partially or entirely formed of a metal alloy, the reinforcing coating materials may optionally be used to form various coating colors (e.g., gold, copper, brass, black, rose gold, chrome, 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 micrometers and all values ​​and ranges therein), and is typically 0.1-25 micrometers, more typically 0.2-10 micrometers. In another non-limiting embodiment, the hardness of the reinforcing coating may be at least 5 GPa (ASTM C1327-15 or ASTM C1624-05), typically 5-50 GPa (and all values ​​and ranges therebetween), more typically 10-25 GPa, and even more typically 14-24 GPa. In another non-limiting embodiment, the coefficient of friction (COF) of the reinforcing coating may be 0.04-0.2 (and all values ​​and ranges therebetween), and typically 0.6-0.15. In another non-limiting embodiment, the wear rate of the reinforcing coating may be from 0.5 x 10⁻⁷ mm³ / Nm to 3 x 10⁻⁷ mm³ / Nm (and all values ​​and ranges therebetween), and typically from 1.2 x 10⁻⁷ mm³ / Nm to 2 x 10⁻⁷ mm³ / Nm. In another non-limiting embodiment, the silicon-based precursor (e.g., trimethylsilane, tetramethylsilane, hexachlorodisilane, silane, dichlorosilane, trichlorosilane, silicon tetrachloride, tris(dimethylamino)silane, bis(tert-butylamino)silane, trimethylsilylamine, allyltrimethoxysilane, (3-aminopropyl)triethoxysilane, butyltrichlorosilane, n-sec-butyl(trimethylsilyl)amine, pentachlorodisilane, 1,2-dichlorotetramethyldisilane, [3-(diethylamino)propyl) Trimethoxysilane, 1,3-diethyl-1,1,3,3-tetramethyldisilazane, dimethoxydimethylsilane, dodecylcyclohexasilane, hexamethyldisilazane, isobutyl(trimethoxy)silane, methyltrichlorosilane, 2,4,6,8,10-pentamethylcyclopentasiloxane, pentamethyldisilazane, n-propyltriethoxysilane, silicon tetrabromide, silicon tetrabromide, etc. may optionally be used to facilitate the application of the reinforcing coating to one or more portions or all of the frame for an artificial heart valve.

[0042] According to another and / or alternative non-limiting aspect of this disclosure, the frame for an artificial heart valve may be partially or completely coated with a reinforcing coating composition comprising a chromium nitride (CrN) coating. A portion or all of the frame for an artificial heart valve may be partially or completely coated with a chromium nitride (CrN) coating. The reinforcing coating can be used to increase hardness, improve toughness, reduce friction, resist impact wear, improve corrosion and oxidation resistance, and / or form a reduced tacky surface when in contact with many different materials. According to a non-limiting embodiment, the chromium nitride (CrN) coating typically comprises 40-85 wt% Cr (and all values ​​and ranges therebetween), 15-60 wt% N (and all values ​​and ranges therebetween), 0-10 wt% Re (and all values ​​and ranges therebetween), 0-10 wt% Si (and all values ​​and ranges therebetween), 0-2 wt% O (and all values ​​and ranges therebetween), and 0-2 wt% C (and all values ​​and ranges therebetween). In one non-limiting coating process, all or part of the frame for an artificial heart valve is initially coated with Cr metal. The Cr metal coating can be applied in an inert environment by PVD, CVD, ALD, and PE-CVD. The Cr metal coating thickness is 0.5-15 micrometers. Subsequently, the Cr metal coating is exposed to nitrogen and / or nitrogen-containing gaseous compounds to allow nitrogen to react with the Cr metal coating, thereby forming a CrN layer on the outer surface of the Cr metal coating and / or the outer surface of the frame for the artificial heart valve. Cr metal particles may optionally be mixed with nitrogen and / or nitrogen-containing gaseous compounds to promote the formation of the CrN coating. When using Cr metal particles, the initial Cr coating on the frame for the artificial heart valve may optionally be removed. In another non-limiting embodiment, the reinforcing coating composition typically comprises 65-80 wt% Cr, 15-30 wt% N, 0-8 wt% Re, 0-1 wt% Si, 0-1 wt% O, and 0-1 wt% C.

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

[0044] According to another and / or alternative non-limiting aspect of this disclosure, a frame for an artificial heart valve may be partially or completely coated with a reinforcing coating composition including a titanium nitride (TiN) coating. A portion or all of the outer surface of the frame for the artificial heart valve may include a titanium nitride (TiN) coating. The reinforcing coating can be used to increase hardness, improve toughness, enhance corrosion and oxidation resistance, reduce friction, and / or form a reduced tack surface when in contact with many different materials. In one non-limiting embodiment, all or part of the outer surface of the frame for the artificial heart valve is optionally initially coated with Ti metal. When applied, the Ti metal coating may be applied in an inert environment via PVD, CVD, ALD, and PE-CVD. The Ti metal coating thickness is 0.05–15 micrometers (and all values ​​and ranges therebetween). As will be understood, the initial Ti coating is optional. Subsequently, upon application, the Ti metal coating is exposed to nitrogen and / or nitrogen-containing gaseous compounds and optional titanium particles to allow the nitrogen to react with the Ti metal coating and / or titanium particles, thereby forming a TiN layer on the outer surface of the Ti metal coating and / or the outer surface of the frame for the artificial heart valve. If no titanium layer is pre-applied, the TiN coating can be formed by exposing the frame for the artificial heart valve to titanium particles and nitrogen and / or nitrogen-containing gaseous compounds. The thickness of the TiN coating is typically 0.1–15 micrometers (and all values ​​and ranges therebetween), and is generally 0.2–2 micrometers.

[0045] According to another and / or alternative non-limiting aspect of this disclosure, the frame for an artificial heart valve may be partially or completely coated with a reinforcing coating composition including a titanium oxynitride (TiNOx) coating. A portion or all of the outer surface of the frame for the artificial heart valve may include a titanium oxynitride (TiNOx) coating. The reinforcing coating can be used to increase hardness, improve toughness, enhance corrosion and oxidation resistance, reduce friction, and / or form a reduced tacky surface when in contact with many different materials. In one non-limiting embodiment, all or part of the outer surface of the frame for the artificial heart valve is optionally initially coated with Ti metal. When applied, the Ti metal coating may be applied in an inert environment by PVD, CVD, ALD, and PE-CVD. The Ti metal coating thickness is 0.05-15 micrometers (and all values ​​and ranges therebetween). As will 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, oxygen, nitrogen-containing gaseous compounds, and / or oxygen-containing gaseous compounds, to allow the nitrogen and oxygen to react with the Ti metal coating (if such a coating is used) and / or with the Ti metal particles to form a TiNOx layer on the outer surface of the Ti metal coating and / or the outer surface of the frame for the artificial heart valve. The N to O ratio can be varied to control the O content in the TiNOx coating. If no titanium layer is pre-applied, the TiNOx coating can be formed by exposing the frame for the artificial heart valve to titanium particles and nitrogen and oxygen sources, such as nitrogen, oxygen, nitrogen-containing gaseous compounds, and / or oxygen-containing gaseous compounds. When forming the TiNOx coating, the N to O ratio is typically 1:10 to 10:1 (and all values ​​and ranges therebetween). The coating thickness of the TiNOx coating is typically 0.1–15 micrometers (and all values ​​and ranges therebetween), and is typically 0.2–2 micrometers. In another non-limiting embodiment, a TiNOx coating is applied to a portion or all of the outer surface of a frame for an artificial heart valve, and the TiNOx coating is formed by: a) exposing a portion of the outer surface of the entire frame for 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 the entire portion of the frame for the artificial heart valve, wherein the thickness of the Ti coating is 0.05-5 micrometers; and b) exposing the Ti coating to a nitrogen and oxygen source, such as nitrogen, oxygen, nitrogen-containing gaseous compounds, and / or oxygen-containing gaseous compounds, to form a TiNOx coating, wherein the N to O ratio is typically 1:10 to 10:1 when the TiNOx coating is formed, and wherein the thickness of the TiNOx coating is 0.2-5 micrometers.In another non-limiting embodiment, a TiNOx coating is applied to a portion or all of the outer surface of a frame for an artificial heart valve, and the TiNOx coating is formed by exposing a portion or all of the outer surface of the frame for the artificial heart valve to Ti particles and nitrogen and oxygen sources (such as nitrogen, oxygen, nitrogen-containing gas compounds and / or oxygen-containing gas compounds) to form the TiNOx coating, wherein the N to O ratio is typically 1:10 to 10:1 when the TiNOx coating is formed, and wherein the thickness of the TiNOx coating is 0.2-5 micrometers. In another non-limiting embodiment, the reinforcing coating composition typically comprises 20-85 wt% Ti (and all values ​​and ranges therebetween), 0.5-35 wt% N (and all values ​​and ranges therebetween), 0-10 wt% Re (and all values ​​and ranges therebetween), and 0.5-35 wt% O (and all values ​​and ranges therebetween). In another non-limiting embodiment, the TiNOx coating is formed on the frame for the artificial heart valve by reactive physical vapor deposition in a vacuum chamber. Based on the oxygen-nitrogen ratio during vapor deposition, TiNOx coating deposits with defined composition and resistivity can be applied to the outer surface of a frame for use in artificial heart valves.

[0046] According to another and / or alternative non-limiting aspect of this disclosure, a frame for an artificial heart valve may be partially or completely coated with a reinforcing coating composition comprising a zirconium nitride (ZrN) coating. The reinforcing coating can be used to increase hardness, improve toughness, enhance corrosion and oxidation resistance, reduce friction, and / or form a reduced tack surface when in contact with many different materials. In one non-limiting embodiment, all or part of the outer surface of the frame for the artificial heart valve is initially coated with Zr metal. The Zr metal coating may be applied in an inert environment by PVD, CVD, ALD, and PE-CVD. The Zr metal coating thickness is 0.5-15 micrometers. Subsequently, the Zr metal coating is exposed to nitrogen and / or nitrogen-containing gaseous compounds to allow nitrogen to react with the Zn metal coating, thereby forming a ZrN layer on the outer surface of the Zr metal coating and / or the outer surface of the frame for the artificial heart valve. Zr metal particles may optionally be mixed with nitrogen and / or nitrogen-containing gaseous compounds to promote the formation of the ZrN coating. When using Zr metal particles, the initial Zr coating on the frame for the artificial heart valve can optionally be eliminated. ZrN coatings have been found to produce a gold-colored enhancement coating. In another non-limiting embodiment, the enhancement coating composition typically comprises 35-90 wt% Zr (and all values ​​and ranges therebetween), 5-25 wt% N (and all values ​​and ranges therebetween), 0-10 wt% Re (and all values ​​and ranges therebetween), 0-20 wt% Si (and all values ​​and ranges therebetween), 0-2 wt% O (and all values ​​and ranges therebetween), and 0-2 wt% C (and all values ​​and ranges therebetween). In another non-limiting embodiment, the enhancement coating composition typically 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 this disclosure, a frame for an artificial heart valve may be partially or completely coated with a reinforcing coating composition comprising a zirconium oxide (ZrO2) coating. The reinforcing coating can be used to increase hardness, improve toughness, enhance corrosion and oxidation resistance, reduce friction, and / or form a reduced tacky surface when in contact with many different materials. In one non-limiting embodiment, all or part of the outer surface of the frame for the artificial heart valve is initially coated with Zr metal. The Zr metal coating may be applied in an inert environment by PVD, CVD, ALD, and PE-CVD. The Zr metal coating thickness is 0.5-15 micrometers. Subsequently, the Zr metal coating is exposed to oxygen and / or oxygen-containing gas compounds to allow oxygen to react with the Zn metal coating, thereby forming a layer of zirconium oxide (ZrO2) on the outer surface of the Zr metal coating and / or the outer surface of the frame for the artificial heart valve. Zr metal particles may optionally be mixed with oxygen and / or oxygen-containing gas compounds to promote the formation of the ZrO2 coating. When using Zr metal particles, the initial Zr coating on the framework for artificial heart valves can optionally be eliminated. Zirconia (ZrO2) coatings have been found to produce a blue-enhancing coating color. In another non-limiting embodiment, the enhancing coating composition typically comprises 35-90 wt% Zr (and all values ​​and ranges therebetween), 10-35 wt% O (and all values ​​and ranges therebetween), 0-2 wt% N (and all values ​​and ranges therebetween), 0-10 wt% Re (and all values ​​and ranges therebetween), 0-20 wt% Si (and all values ​​and ranges therebetween), and 0-2 wt% C (and all values ​​and ranges therebetween). In another non-limiting embodiment, the enhancing coating composition typically comprises 70-80 wt% Zr, 20-30 wt%, 0-1 wt% N, 0-8 wt% Re, 0-1 wt% Si, and 0-1 wt% C.

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

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

[0050] According to another and / or alternative non-limiting aspect of this disclosure, one or more components of the frame for an artificial heart valve 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]. A portion or all of the outer surface of one or more components of the frame for an artificial heart valve may include zirconium oxynitride (ZnNxOy). The reinforcing coating can be used to increase hardness, improve toughness, improve corrosion and oxidation resistance, reduce friction, form a reduced viscous surface when in contact with many different materials, and / or promote the formation of nitric oxide 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 frame for an artificial heart valve is optionally initially coated with Zr metal. When applied, the Zr metal coating may be applied in an inert environment by PVD, CVD, ALD, and PE-CVD. The Zr metal coating thickness is 0.05–15 micrometers (and all values ​​and ranges therebetween). It is understood that the initial Zr coating is optional. Subsequently, the Zr metal coating is exposed to zirconium particles and a nitrogen and oxygen mixture, which may include nitrogen, oxygen, nitrogen-containing gaseous compounds, and / or oxygen-containing gaseous compounds, to allow the nitrogen and oxygen to react with the Zr metal coating (if such a coating is used) and / or with the Zr metal particles to form a ZnNxOy layer on the outer surface of the Zr metal coating and / or on the outer surface of one or more components of the frame for an artificial heart valve. The N to O ratio can be varied to control the O and N content in the ZrNxOy coating. If no zirconium layer is pre-applied, the ZrNxOy coating can be formed by exposing the outer surface of one or more components of the frame for an artificial heart valve to zirconium particles and nitrogen and oxygen sources, such as nitrogen, oxygen, nitrogen-containing gaseous compounds, and / or oxygen-containing gaseous compounds. When forming a ZrNxOy coating, the N to O ratio is typically 1:10 to 10:1 (and all values ​​and ranges in between). The coating thickness of the ZrNxOy coating is typically 0.1–15 micrometers (and all values ​​and ranges in between), and is typically 0.2–2 micrometers.In another non-limiting embodiment, a ZrNxOy coating is applied to a portion or all of the outer surface of one or more components of a frame for an artificial heart valve, and the ZrNxOy coating is formed by: a) exposing a portion of the outer surface of all of the components of the frame for an 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 of the components of the frame for an artificial heart valve, and wherein the thickness of the Zr coating is 0.05-5 micrometers; and b) exposing the Zr coating to a nitrogen source and an oxygen source, such as nitrogen, oxygen, nitrogen-containing gaseous compounds, and / or oxygen-containing gaseous compounds, to form the ZrNxOy coating, and wherein the N to O ratio is typically 1:10 to 10:1 when the ZrNxOy coating is formed, and wherein the thickness of the ZrNxOy coating is 0.2-5 micrometers. In another non-limiting embodiment, a ZrNxOy coating is applied to a portion or all of the outer surface of one or more components of a frame for an artificial heart valve, and the ZrNxOy coating is formed by exposing a portion or all of the outer surface of one or more components of the frame for the artificial heart valve to Zr particles and nitrogen and oxygen sources (such as nitrogen, oxygen, nitrogen-containing gas compounds and / or oxygen-containing gas compounds) to form the ZrNxOy coating, wherein the N to O ratio is typically 1:10 to 10:1 when the ZrNxOy coating is formed, and wherein the coating thickness of the ZrNxOy coating is 0.2-5 micrometers. In another non-limiting embodiment, the reinforcing coating composition typically comprises 20-85 wt% Zr (and all values ​​and ranges therebetween), 0.5-35 wt% N (and all values ​​and ranges therebetween), and 0.5-35 wt% O (and all values ​​and ranges therebetween). In another non-limiting embodiment, a ZrNxOy coating is formed on one or more components of a frame for an artificial heart valve by reactive physical vapor deposition in a vacuum chamber. Depending on the oxygen-nitrogen ratio during vapor deposition, a ZrNxOy coating deposit having a defined composition and resistivity can be applied to the outer surface of one or more components of the frame for an artificial heart valve.

[0051] According to another and / or alternative non-limiting aspect of this disclosure, a frame for an artificial heart valve may be partially or completely coated with a reinforcing coating composition comprising a zirconium-nitrogen-carbon (ZrNC) coating. The reinforcing coating can be used to increase hardness, improve toughness, enhance corrosion and oxidation resistance, reduce friction, and / or form a reduced tacky surface when in contact with many different materials. In one non-limiting embodiment, all or part of the outer surface of the frame for the artificial heart valve is initially coated with Zr metal. The Zr metal coating may be applied in an inert environment by PVD, CVD, ALD, and PE-CVD. The Zr metal coating thickness is 0.5-15 micrometers. Subsequently, the Zr metal coating is exposed to nitrogen and / or nitrogen-containing gaseous compounds, and then to carbon and / or carbon-containing gaseous compounds (e.g., methane and / or acetylene). The color of the ZrNC will vary depending on the amount of C and N in the coating. Zr metal particles may optionally be mixed with nitrogen and / or nitrogen-containing gaseous compounds as well as carbon and / or carbon-containing gaseous compounds to promote the formation of the ZrNC coating. When using Zr metal particles, the initial Zr coating on the frame for the artificial heart valve can optionally be eliminated. In one non-limiting embodiment, the reinforcing coating composition typically comprises 40-95 wt% Zr (and all values ​​and ranges therebetween), 5-40 wt% N (and all values ​​and ranges therebetween), 5-40 wt% C (and all values ​​and ranges therebetween), 0-2 wt% O (and all values ​​and ranges therebetween), 0-10 wt% Re (and all values ​​and ranges therebetween), and 0-20 wt% Si (and all values ​​and ranges therebetween). In another non-limiting embodiment, the reinforcing coating composition typically comprises 40-80 wt% Zr, 5-25 wt% N and 5-25 wt% C, 0-1 wt% O, 0-8 wt% Re and 0-1 wt% Si.

[0052] According to another and / or alternative non-limiting aspect of this 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 leaflet structure. The artificial heart valve can be implanted into a natural aortic valve annulus; however, the artificial heart valve can also be configured for implantation into 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, wherein the lower end of the artificial heart valve is the inflow end, and the upper end of the artificial heart valve is the outflow end.

[0053] According to another and / or alternative non-limiting aspect of this disclosure, the expandable frame of the artificial heart valve is configured to radially collapse to a collapsed or coiled state for introduction into the body (e.g., on a delivery catheter, etc.) and radially expand to an expanded state for implantation of the artificial heart valve at a desired location in the heart (e.g., aortic valve, tricuspid valve, pulmonary valve, mitral valve, etc.). The expandable frame of the artificial heart valve is formed of a plastic expandable material that allows the frame to be coiled into a smaller profile for delivery and expansion at the treatment site. Expansion of the coiled frame of the artificial heart can be achieved by an expansion device (such as, but not limited to, a balloon in a balloon catheter). The expandable frame and / or artificial heart valve may be configured to roll up to a diameter of less than 24 FR (e.g., less than 8 mm, 5-7.9 mm, etc.), and the expandable frame and / or artificial heart valve may be configured to expand to a diameter of at least 14 mm (e.g., 14-35 mm and all values ​​and ranges therein); however, it is understood that the expandable frame and / or artificial heart valve may be designed to roll up to a larger diameter and / or expand to a larger diameter.

[0054] According to another and / or alternative non-limiting aspect of this disclosure, the expandable frame of the artificial heart valve is formed by a plurality of angularly spaced angularly hinged members and vertically extending axial longitudinal members. The angularly hinged members and the vertically extending axial longitudinal members are interconnected to form a variety of patterns (e.g., serrated patterns, sawtooth patterns, triangular patterns, polygonal patterns, elliptical patterns, etc.). One or more of the angularly hinged members and the 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 this disclosure, an artificial heart valve includes a) a balloon-expandable, mechanically expandable, or self-expandable expandable frame, and b) at least one leaflet (e.g., 1-6 leaflets and all values ​​and ranges therebetween). 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 grids organized in rows or columns, the plurality of frame grids being arranged in a cylindrical shape having proximal and distal ends. The metallic frame is formed of a metallic alloy, which undergoes plastic deformation and / or elastic deformation to allow the expandable frame to expand and compress (curl) to different geometries.

[0056] According to another and / or alternative non-limiting aspect of this disclosure, the frame has an open grid construction, wherein the grid of the expandable metal frame includes axial longitudinal members and angular hinge members, wherein the angular hinge members are connected to each other by hinge joints, and wherein the axial longitudinal members are connected to the angular hinge members by base joints. In one non-limiting embodiment, the expandable frame has a perspective shortening of no more than 20%, and typically no more than 5%, and the frame grid consists of at least two pairs of axial longitudinal members and at least two pairs of angular hinge members, wherein each pair includes at least two angular hinge members connected by hinge joints, and wherein during the expansion or compression of the expandable frame, the total longitudinal length of the frame grid does not exceed the height of the axial longitudinal members. In one non-limiting construction, the expandable frame is formed by a plurality of non-perspective shortened frame grids. In another non-limiting construction, the angular hinge members in all grids of a row of frame grids and / or a column of frame grids have the same length. In another non-limiting configuration, the length of the angular hinge members is measured from peak to peak at the joint defining the ends of the angular hinge members, and the sum of the lengths of the angular hinge 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 hinge members has independent curvature over its width at least a portion of its length through the angular hinge members. In another non-limiting embodiment, the entire frame does not undergo perspective shortening during the expansion and / or curling of the expandable frame, even when one or more frame grids in the frame grid undergo perspective shortening. In another non-limiting configuration, the longitudinal length between the proximal and distal ends of the expandable frame is substantially constant or constant during changes in the diameter of the expandable frame. In another non-limiting configuration, one or more longitudinal columns extend across the entire distance from the distal to the proximal end of the expandable frame. In another non-limiting construction, the expandable frame includes at least one axial longitudinal member extending from the distal end of the frame to the proximal end, and a joining attachment region is located between the proximal and distal ends of the expandable frame. In another non-limiting construction, the longitudinal distance from the joining attachment region to the proximal end of the frame is primarily constant during the expansion and / or curling of the expandable frame. In another non-limiting construction, the rows and columns of the frame mesh of the expandable frame are made of frame meshes having the same width or height as adjacent circumferential or axial meshes. In another non-limiting construction, the difference in cross-sectional area of ​​the window region of one or more frame meshes of the expandable frame does not exceed 20% when compared with other meshes in the same row and / or column of the expandable frame. In another non-limiting construction, the expandable frame consists of an even or odd number of meshes per row. In another non-limiting construction, the expandable frame includes an odd number of meshes.In another non-limiting configuration, the grid of one or more rows, or all rows, of the expandable frame is formed by nine grids. In another non-limiting configuration, only the distal rows are formed by an odd number of frame grids, and the other rows are formed by an even number of frame grids. In another non-limiting configuration, an artificial heart valve is inserted into the heart such that when the expandable frame expands, one or more frame grids in the frame grid will be positioned partially or completely across the entrance of the coronary artery.

[0057] According to another and / or alternative non-limiting aspect of this disclosure, the material used to form the expandable metallic frame contains very little or no nickel. Nickel and cobalt are commonly used alloys in the frames of commercial artificial heart valves, although such materials exhibit suboptimal results in terms of biocompatibility. In one non-limiting embodiment, the metallic 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 metallic alloy used to form the expandable frame is completely free of nickel and / or cobalt. In another non-limiting configuration, the metallic alloy used to form the expandable frame contains rhenium and optionally contains chromium and / or molybdenum. In yet another non-limiting configuration, the metallic 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 the expandable metal frame has a high yield strength to impart radial strength to the expandable frame. In one non-limiting embodiment, the material used to form the expandable metal frame has a yield strength of at least 110 ksi. In one non-limiting embodiment, the material used to form the expandable metal frame has an elongation of at least 20%. In one non-limiting embodiment, the material used to form the expandable metal frame has a yield strength of at least 110 ksi and an elongation of at least 20%. In one non-limiting embodiment, when the expandable frame is in its finished state (e.g., finished state is defined as the material properties after undergoing any material processing such as heating, annealing, cold working, etc. during manufacturing, thermal processing, etc.), the material used to form the expandable metal frame has a yield strength of at least 110 ksi and / or an elongation of at least 20%. Finished state means material ready to be sterilized or implanted or transported to a customer in the form of a medical device). In one non-limiting embodiment, the material used to form the expandable metal frame has low recoil to limit tissue or conductive damage during implantation. In another non-limiting embodiment, when the frame undergoes plastic deformation (e.g., expands from a coiled state to an expanded state, coils, etc.) and no further expansion force is applied to the expanded frame (e.g., the delivery balloon has contracted and no load is applied to the expanded frame), the material used to form the expandable metal frame has an elastic modulus of at least 52,000 ksi and / or a recoil of no more than 5%.

[0059] According to another and / or alternative non-limiting aspect of this disclosure, the expandable frame may include distinguishing features that allow rotational alignment of the expandable frame with the junction of the natural heart valve. In one non-limiting embodiment, one or more distinguishing features on the expandable heart valve are asymmetrical to identify rotational alignment of the expandable frame. In another non-limiting embodiment, one or more distinguishing features are directly attached to the junction of the artificial heart valve frame. In another non-limiting embodiment, one or more distinguishing features may be formed of a radiopaque material that allows for high visibility during the procedure of inserting the artificial heart valve into the heart. In another non-limiting embodiment, one or more distinguishing features are at least partially made of a material with a density of at least 10 mg / cm³. One or more distinguishing features may be formed of the same or different material as the body of the frame.

[0060] According to another and / or alternative non-limiting aspect of this disclosure, the expandable frame of the artificial heart valve may optionally be coated with a polymeric material (e.g., silicone, PTFE, ePTFE, polyurethane, polyolefin, hydrogel, biomaterial (e.g., pericardium or biopolymers such as collagen, gelatin, or hyaluronic acid derivatives)). The coating may be used to partially or completely encapsulate the angular hinge members and / or the vertically extending axial longitudinal members on the frame and / or fill the openings between the angular hinge members and / or the vertically extending axial longitudinal members on the frame.

[0061] According to another and / or alternative non-limiting aspect of this disclosure, an artificial heart valve is provided, optionally comprising an inner skirt, wherein the inner skirt may be formed of a variety of flexible materials, such as polymers [e.g., polyethylene terephthalate (PET), polyester, nylon, Kevlar®, silicone, etc.], composite materials, metals, fabric 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 non-compressible). In another non-limiting embodiment, the material used to partially or completely form the inner skirt may optionally be a stretchable and / or compressible material (e.g., silicone, PTFE, ePTFE, polyurethane, polyolefin, hydrogel, biomaterials [e.g., pericardium or biopolymers such as collagen, gelatin, or hyaluronic acid derivatives], etc.). The inner skirt may optionally be formed of a combination of fabric or woven materials coated with a flexible material or a stretchable and / or compressible material to provide additional structural integrity to the inner skirt. The dimensions, construction, and thickness of the inner skirt are non-limiting (e.g., thicknesses from 0.1 to 20 mils and all values ​​and ranges therebetween). The inner skirt can be secured to the interior and / or exterior of the frame in various ways (e.g., sutures, clamping devices, etc.). In another non-limiting embodiment, the inner skirt may be made of a woven material; however, nonwoven materials may also be used or alternatively. In another non-limiting embodiment, the inner skirt (when used) may be used to 1) at least partially seal and / or prevent paravalvular leakage, 2) at least partially secure the leaflet structure to the frame, 3) at least partially protect the leaflets from damage during curling and / or expansion processes, and / or 4) at least partially protect the leaflets from damage during the operation of an artificial heart valve in the heart.

[0062] According to another and / or alternative non-limiting aspect of this disclosure, an artificial heart valve is provided, optionally comprising an outer skirt or sleeve positioned at least partially around an outer region of a frame. The outer skirt or sleeve is typically positioned completely around a portion of the outer surface of the frame. Typically, the outer skirt is positioned around the lower portion of the frame but does not completely cover the upper portion of the frame; however, this is not required. The outer skirt can be attached to the frame by various methods, such as sutures, adhesives, fusion bonding, clamping devices, etc. At least a portion of the outer skirt may optionally be located on an inner surface of the frame. Typically, the outer skirt is formed of a more flexible and / or compressible material than the inner skirt; however, this is not required. The outer skirt can be formed of a variety of stretchable and / or compressible materials, such as silicone, PTFE, ePTFE, polyurethane, polyolefins, hydrogels, biomaterials [e.g., pericardium or biopolymers such as collagen, gelatin, or hyaluronic acid derivatives], etc. The outer skirt may optionally be formed from a combination of fabric or woven materials coated with a stretchable and / or compressible material to provide additional structural integrity. In another non-limiting embodiment, the outer skirt may be made of a woven material; however, nonwoven materials may also be used or alternatively. The dimensions, construction, and thickness of the outer skirt are non-limiting. The thickness of the outer skirt is typically from 0.1 to 20 mils (and all values ​​and ranges therebetween).

[0063] According to another and / or alternative non-limiting aspect of this disclosure, the artificial heart valve includes a leaflet structure capable of attaching to a frame and / or skirt. Connection methods for securing the leaflet structure to the frame and / or skirt are non-limiting (e.g., sutures, fusion bonding, adhesives, clamping devices, etc.). Materials used to form the leaflet structure include polymers, bovine pericardial tissue, bovine tissue, porcine tissue, biocompatible synthetic materials, or various other suitable natural or synthetic materials. Tissue used to form one or more leaflets may optionally be treated / stabilized by collagen cross-linking and then dried or moistened for storage (e.g., dried storage after a glycerol-based dehydration process, etc.). In one non-limiting embodiment, the leaflet structure comprises two or more leaflets (e.g., 2, 3, 4, 5, 6, etc.). In one non-limiting arrangement, the leaflet structure includes three leaflets arranged to collapse in a tricuspid valve configuration. The construction of the leaflet structure is non-limiting. In another non-limiting embodiment, two or more leaflets of the leaflet structure may optionally be secured to each other on their adjacent sides to form a junction (edge ​​of leaflet confluence) of the leaflet structure. The leaflet structure can be secured together using various connection methods (e.g., sutures, adhesives, fusion bonding, clamping devices, etc.). In another non-limiting embodiment, one or more leaflets may optionally include reinforcing structures or strips to 1) facilitate securing the leaflets together, 2) facilitate securing the leaflets to the skirt and / or frame, and / or 3) inhibit or prevent tearing or other types of damage to the leaflets.

[0064] According to another and / or alternative non-limiting aspect of this disclosure, an artificial heart valve is provided, configured for insertion into a desired location in the body (e.g., an aortic valve, tricuspid valve, pulmonary valve, mitral valve). The frame of the artificial heart valve may be at least partially formed of a plastic expandable material that allows the frame to be rolled into a smaller profile for delivery of the artificial heart valve and expanded into a larger profile. Expansion of the rolled-up frame may optionally utilize an expansion device, such as, but not limited to, a balloon on a balloon catheter.

[0065] According to another and / or alternative non-limiting aspect of this disclosure, using a metal alloy to partially or completely form the frame of an artificial heart valve, compared to stainless steel, chromium-cobalt alloys, or titanium alloys, can increase the strength and / or stiffness and / or durability of the artificial heart valve frame; thus, similar strength can be achieved in the artificial heart valve frame using a smaller amount of metal alloy compared to frames formed of different metals. Therefore, by using a metal alloy, the resulting artificial heart valve can be made smaller and more voluminous without sacrificing strength and durability. Such artificial heart valves can have smaller profiles and can therefore be inserted into smaller areas, openings, and / or channels. Metal alloys can also increase the radial strength of the artificial heart valve frame. For example, the thickness of the angular hinge members and / or vertically extending axial longitudinal members and / or the wires used to at least partially form the frame of the artificial heart valve can be made thinner, achieving similar or improved radial strength, compared to thicker-walled frames of artificial heart valves formed of stainless steel, titanium alloys, or cobalt and chromium alloys. This metal alloy also improves the stress-strain characteristics, bending, and flexibility of the artificial heart valve frame, thereby increasing the lifespan of the artificial heart valve. For example, the artificial heart valve can be used in areas where it is subjected to bending. Because the metal alloy improves the physical properties of the artificial heart valve, it has enhanced fracturing resistance in such frequent bending environments. Alternatively, the improved bending and flexibility of the artificial heart valve frame due to the use of the metal alloy allows for easier insertion into various areas of the body. The metal alloy also reduces the degree of recoil during the coiling and / or expansion of the artificial heart valve frame. For example, due to the use of the metal alloy, the artificial heart valve better maintains its coiled form and / or better maintains its expanded form after expansion. Thus, when the artificial heart valve is mounted onto the delivery device while coiled, it better maintains its smaller profile during insertion into various areas of the body. Moreover, the artificial heart valve better maintains its expanded profile after expansion to facilitate successful placement of the artificial heart valve frame in the treatment area. In addition to the improved physical properties of the artificial heart valve frame through the use of metal alloys, metal alloys may also optionally have improved radiopaque properties compared to standard materials such as stainless steel or cobalt-chromium alloys, thereby reducing or eliminating the need for marking materials on the artificial heart valve frame.

[0066] According to another and / or alternative non-limiting aspect of this disclosure, using a metallic alloy to form all or part of an artificial heart valve can result in several advantages over artificial heart valves formed from other materials. These advantages include, but are not limited to: Compared to stainless steel, chromium-cobalt alloys, or titanium alloys, the metal alloys used to partially or completely form the framework of an artificial heart valve optionally have increased strength and / or stiffness. Therefore, similar strength can be achieved in an artificial heart valve using a smaller amount of metal alloy compared to artificial heart valves made of different metals. Thus, by using metal alloys, the resulting artificial heart valve can be made smaller and more voluminous without sacrificing its strength and durability. The artificial heart valve can also have a smaller profile, allowing it to be inserted into smaller areas, openings, and / or channels. Thinner metal alloy angular hinge members and / or vertically extending axial longitudinal members used to form the framework or other parts of the artificial heart valve can be used to form the framework or other parts of the artificial heart valve, possessing the strength required for thicker angular hinge members and / or vertically extending axial longitudinal members or other structures of the artificial heart valve when formed of stainless steel, chromium-cobalt alloys, or titanium alloys.

[0067] The increased strength of the metal alloy used in the framework of an artificial heart valve optionally results in increased radial strength of the artificial heart valve. For example, the walls of an artificial heart valve can optionally be made thinner and achieve similar or increased radial strength compared to thicker-walled artificial heart valves made of stainless steel, cobalt and chromium alloys, or titanium alloys.

[0068] Compared to stainless steel, chromium-cobalt alloys, or titanium alloys, the metal alloys used to partially or completely form the framework of an artificial heart valve optionally exhibit a reduced degree of recoil during the coiling and / or expansion of the artificial heart valve. Due to the use of metal alloys, artificial heart valves formed from metal alloys better maintain their coiled form and / or better maintain their expanded form after expansion. Thus, when the artificial heart valve is mounted onto a delivery device while coiled, it better maintains its smaller profile during insertion into the body channel. Furthermore, the artificial heart valve better maintains its expanded profile after expansion, facilitating successful placement of the artificial heart valve framework in the treatment area.

[0069] Compared to artificial heart valves made of stainless steel, chromium-cobalt alloys, or titanium alloys, the use of metallic alloys in the framework of artificial heart valves optionally results in the artificial heart valves better conforming to irregularly shaped body channels when they expand within the body.

[0070] Compared to standard materials such as stainless steel or cobalt-chromium alloys, the metallic alloys used to partially or completely form the framework of artificial heart valves optionally have improved radiopaque properties, thereby reducing or eliminating the need for marking materials on the artificial heart valves. For example, the radiopaqueness of metallic alloys is at least about 10 to 20% higher than that of stainless steel or cobalt-chromium alloys.

[0071] Compared to cold working of stainless steel, chromium-cobalt alloys or titanium alloys, metal alloys used to partially or completely form the framework of artificial heart valves optionally have improved fatigue ductility when subjected to cold working.

[0072] Compared to stainless steel, chromium-cobalt alloys, or titanium alloys, metal alloys used to partially or completely form the framework of an artificial heart valve optionally have improved durability.

[0073] Compared to stainless steel, chromium-cobalt alloys, or titanium alloys, the metal alloys used to partially or completely form the framework of artificial heart valves optionally have improved hydrophilicity.

[0074] Compared to stainless steel, chromium-cobalt alloys, or titanium alloys, the metal alloys used to partially or completely form the framework of an artificial heart valve optionally have reduced ion release in the body's channels.

[0075] Optionally, the metal alloy used to partially or completely form the framework of an artificial heart valve is less irritating to the body than stainless steel, cobalt-chromium alloys, or titanium alloys, thus leading to reduced inflammation, faster healing, and increased success rates for the artificial heart valve. When the artificial heart valve expands within the body's channels, it may cause some minor damage to the interior of those channels. As the body begins to heal from such minor damage, the presence of metal alloys elicits fewer adverse reactions compared to other metals, such as stainless steel, cobalt-chromium alloys, or titanium alloys.

[0076] The metal alloy used to partially or completely form the framework of the artificial heart valve optionally has a lower magnetic susceptibility than CoCr alloys, TiAlV alloys and / or stainless steel, resulting in a lower incidence of potential defects in the artificial heart valve or patient complications after implantation when the patient is subjected to MRI or other artificial heart valves that generate strong magnetic fields.

[0077] According to another and / or alternative non-limiting aspect of this disclosure, the framework of the artificial heart valve has one or more features, including but not limited to: High radial strength.

[0078] Small or low curled outline.

[0079] Reduce recoil during expansion and / or curling.

[0080] There is little or no perspective shortening during expansion.

[0081] Smooth curvature at the peak and along the angular hinge members.

[0082] A symmetrical design for restoring valve function and for visualization framework.

[0083] Physical markers on the frame used for alignment.

[0084] Open 9-grid design.

[0085] An open grid aligned with the coronary arteries for hemodynamic and re-intervention purposes.

[0086] According to another and / or alternative non-limiting aspect of this disclosure, the artificial heart valve includes a radially collapsible and expandable frame and a leaflet structure comprising a plurality of leaflets. The artificial heart valve may optionally include an annular skirt member that can be positioned between the frame and the leaflet structure. Each side of the leaflet can be secured to an adjacent leaflet. The leaflets are attached to the frame of the artificial heart valve.

[0087] According to another and / or alternative non-limiting aspect of this disclosure, an artificial heart valve includes a radially collapsible and expandable frame comprising a plurality of angularly hinged members, a plurality of axially longitudinal members, and optionally one or more frame opening devices, wherein the angularly hinged members, the plurality of axially longitudinal members, and optionally one or more frame opening devices are connected together to form a plurality of grids in the frame. In a non-limiting arrangement, the expandable frame includes angularly hinged members having a first end and a second end, wherein the plurality of angularly hinged members have a first end and a second end connected to the axially longitudinal members and / or the frame opening devices. A combination of angularly hinged members and axially longitudinal members, or a combination of angularly hinged members, axially longitudinal members, and frame opening devices, is used to form each grid in the grids of the frame. In a non-limiting arrangement, the frame may be formed by two or more sets of grids, wherein each set of grids comprises the same number of grids, and each set of grids optionally has the same number of grids, and each set of grids optionally has the same shape and size as the grids present in one or more other sets of grids. In one non-restrictive construction, the frame is formed by three sets of meshes, each set comprising 6-9 meshes. As can be understood, the frame may comprise 2-10 sets of meshes (and all values ​​and ranges thereof), and each set may comprise 2-16 meshes (and all values ​​and ranges thereof). In one non-restrictive construction, the number, shape, and size of the meshes in each of the three sets are mirror images of each other and have the same shape and size.

[0088] According to another and / or alternative non-limiting aspect of this disclosure, the artificial heart valve includes a radially collapsible and expandable frame, the radially collapsible and expandable frame including one or more frame opening devices located on the top portion of the frame. Each frame opening device may include a lower frame opening and optionally an upper frame opening.

[0089] According to another and / or alternative non-limiting aspect of this disclosure, an artificial heart valve includes a radially collapsible and expandable frame comprising a plurality of axial longitudinal members. In one non-limiting embodiment, one or more axial longitudinal members extend 80-100% (and all values ​​and ranges therebetween) of the longitudinal length of the frame. In one non-limiting configuration, at least 50% (e.g., 50-100% and all values ​​and ranges therebetween) 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 therebetween) of the axial longitudinal members in the frame extend less than 80% (e.g., 30-79% and all values ​​and ranges therebetween) of the longitudinal length of the frame. In another non-limiting configuration, 20-40% of the axial longitudinal members in the frame extend less than 80% of the longitudinal length of the frame. In yet another non-limiting embodiment, the axial longitudinal members are configured to limit or eliminate perspective shortening of the frame when the frame undergoes plastic deformation (e.g., expands from a curled position to an expanded position). When the frame comprises multiple axial longitudinal members having a longitudinal length of 80-100% of the frame's longitudinal length and spaced apart at different locations around the perimeter of the frame, the axial longitudinal members help to suppress or prevent perspective shortening of the frame upon expansion. In a non-limiting configuration, a) two or more axial longitudinal members have a longitudinal length of 90-100% of the frame's longitudinal length, and / or b) one or more axial longitudinal members connected to the frame opening device have a combined longitudinal length of 90-100% of the frame's longitudinal length, and wherein the axial longitudinal member configuration of a) and / or b) helps to suppress or prevent perspective shortening of the frame upon expansion.

[0090] According to another and / or alternative non-limiting aspect of this disclosure, an artificial heart valve includes a radially collapsible and expandable frame comprising a plurality of axial longitudinal members, which are optionally formed from a plurality of axial longitudinal member segments. One or more axial longitudinal members may be formed from a single piece of material or from multiple pieces of material already joined together (e.g., solder joints, welded joints, adhesive joints, mechanical joints, etc.). The number of axial longitudinal member segments used to form each of the axial longitudinal members is non-limiting. In one non-limiting arrangement, the axial longitudinal members are formed from 2-3 axial longitudinal member segments. In one non-limiting embodiment, one or more or all of the axial longitudinal members are formed from a plurality of axial longitudinal member segments. In another non-limiting embodiment, one or more axial longitudinal members are formed as a single strut segment, and one or more axial longitudinal members are formed from a plurality of axial longitudinal member segments. In one non-limiting construction, the frame includes one or more axial longitudinal members formed as single strut segments, and one or more axial longitudinal members formed by a plurality of axial longitudinal member segments, wherein a larger proportion (e.g., 55-90% and all values ​​and ranges therebetween) of the axial longitudinal members are formed by a plurality of 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 another non-limiting embodiment, the thickness, width, and / or cross-sectional area of ​​the axial longitudinal members along the longitudinal axis of the axial longitudinal member may be constant or may vary. In one non-limiting construction, the thickness, width, and / or cross-sectional area of ​​each of the axial longitudinal members varies along the longitudinal axis of the axial longitudinal member. In another non-limiting construction, the thickness, width, and / or cross-sectional area of ​​one or more axial longitudinal member segments positioned closer to the top portion of the frame is smaller than the thickness, width, and / or cross-sectional area of ​​one or more axial longitudinal member segments positioned below the axial longitudinal member segment closer to the top portion of the frame. In another non-limiting embodiment, when the axial longitudinal member is formed by two or more axial longitudinal member segments, the longitudinal lengths of the axial longitudinal member segments may be the same or different. In a non-limiting configuration, the axial longitudinal member formed by two or more axial longitudinal member segments has two or more axial longitudinal member segments with different longitudinal lengths.

[0091] According to another and / or alternative non-limiting aspect of this disclosure, an artificial heart valve includes a radially collapsible and expandable frame comprising a plurality of angular articulated members. In one non-limiting embodiment, the frame includes at least two rows (e.g., 2-12 rows and all values ​​and ranges therebetween) of angular articulated members. In another non-limiting embodiment, the shape, size, and / or construction of a plurality or most or all of the angular articulated members on each row of angular articulated members are identical. In one non-limiting configuration, the shape, size, and construction of all angular articulated members on one or more rows of angular articulated members are identical. In another non-limiting configuration, the shape, size, and construction of some angular articulated members on a row of angular articulated members differ from the shape, size, and construction of other angular articulated members on the same row of angular articulated members.

[0092] According to another and / or alternative non-limiting aspect of this disclosure, an artificial heart valve includes a radially collapsible and expandable frame comprising a plurality of angularly articulated members, wherein the plurality of, most or all of the angularly articulated members are formed by a centrally located arcuate or semicircular portion and a first arm and a second arm extending from each side of the semicircular portion. In one non-limiting embodiment, each of the first arm and the second arm includes one or more undulations. 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 therebetween) of the total longitudinal length of the angularly articulated members. In another non-limiting embodiment, the plurality of angularly articulated members have first and second arms of identical length, size, shape and / or construction. In one non-limiting configuration, the plurality of angularly articulated members have first and second arms of identical length, size, shape and construction. In one non-limiting construction, multiple angularly hinged members have first and second arms with different lengths, dimensions, shapes, and / or constructions. In another non-limiting construction, when the frame is in an expanding orientation, the semicircular portion has an arc length of 60-190° (and all values ​​and ranges therebetween), and when the frame is in a curled or collapsed orientation, the semicircular portion has an arc length of 80-340° (and all values ​​and ranges therebetween).

[0093] According to another and / or alternative non-limiting aspect of this disclosure, the artificial heart valve includes a radially collapsible and expandable frame comprising three or more rows of angular hinge members, wherein the spacing between the angular hinge members between adjacent positioning rows may be the same or different.

[0094] According to another and / or alternative non-limiting aspect of this disclosure, the artificial heart valve includes a radially collapsible and expandable frame comprising one or more frame opening devices that can optionally serve as fixation points for one or more leaflet structures, leaflets, inner skirts, and / or outer skirts. In one non-limiting embodiment, the one or more frame opening devices include a first frame opening and an optional second frame opening. The size and shape of the lower frame opening and the optional upper frame opening are non-limiting. In a non-limiting configuration, the one or more optional upper frame openings can serve as markers to facilitate proper positioning of the frame and the artificial heart valve in the heart.

[0095] According to another and / or alternative non-limiting aspect of this disclosure, the artificial heart valve includes a radially collapsible and expandable frame comprising one or more of the following features: a) high radial strength after frame expansion; b) small curl profile; c) use of a material with minimal recoil after frame expansion; d) little or no fluoroscopic shortening of the frame during expansion; e) smooth curvature at the peak and along the angular articulation members and / or axial longitudinal members of the frame; f) symmetrical design for restoring valve function and visualizing the frame; g) markings on the frame for synaptic alignment; and / or h) an open grid aligned with the coronary arteries for hemodynamic and reintervention purposes.

[0096] A non-limiting object of this disclosure is to provide a refractory metal alloy or a metal alloy containing at least 5 atomic weight percent (e.g., 5-99 atomic weight percent and all values ​​and ranges therein) of rhenium, which can be used to partially or completely form the framework of an artificial heart valve.

[0097] Another and / or alternative non-limiting object of this disclosure is to provide an artificial heart valve comprising a frame formed partially or entirely of a refractory metal alloy or a metal alloy containing at least 5 atomic weight percent (e.g., 5-99 atomic weight percent and all values ​​and ranges therein) of rhenium, and such artificial heart valve improves surgical success rates.

[0098] Another and / or alternative non-limiting object of this disclosure is to provide an artificial heart valve comprising a frame having a novel geometry, combined with a frame formed partially or entirely of a rhenium-containing alloy, enabling the frame to a) have an open-mesh geometry of the artificial heart valve frame, which can be used to reduce the size of the delivery system, thereby reducing vascular and neurological complications; b) use an open-mesh structure with high radial strength due to the high yield strength and ultimate tensile strength of the rhenium-containing metal alloy; c) improve the recovery of physiological EOA in challenging, heavily calcified valves, where the valve exerts high forces on the bioartificial valve while allowing for a reduction in the coil diameter of the vascular access; d) improve the recovery of physiological EOA, thereby extending the lifespan of the bioartificial valve; e) include a material with lower recoil than conventional materials such as stainless steel, chromium-cobalt, or titanium alloys, resulting in less frame recoil during expansion, which leads to a reduced risk of valvular embolism, reduced paravalvular leak due to improved fit to the native anatomy, more precise recovery of physiological EOA, and improved physiological EOA after balloon inflation. EOA requires a smaller balloon inflation diameter, thus reducing conduction system damage; f) It has an open-mesh geometry that allows for a frame geometry without fluoroscopic shortening, which allows for more precise placement of the valve within the native annulus. The absence of fluoroscopic shortening allows for a shorter initial frame length, which reduces conduction system damage; g) It has an open-mesh geometry with commissure alignment marks and an open mesh between the commissures, which allows for proper placement of the bioartificial valve relative to the valve's native commissure to achieve flushing of the valve and to the coronal... Proper hemodynamic function of blood flow in the coronary arteries, which leads to better valve durability and lifespan, as well as accessibility and re-intervention in the coronary arteries, thus preventing future adverse events; h) having an open mesh geometry with radial and longitudinal symmetry and little or no fluoroscopic shortening, which allows for symmetrical and cylindrical expansion of the prosthetic valve, resulting in a lower rate of leaflet thrombosis and structural valve degeneration; and i) being formed of a rhenium-containing metal alloy without nickel content, which prevents allergic reactions due to the presence of nickel and restenosis associated with nickel content.

[0099] Another and / or alternative non-limiting object of this disclosure is to provide an artificial heart valve for implantation in the heart; the artificial heart valve includes an expandable metal frame, a leaflet structure supported by the expandable metal frame, and an inner skirt fixed to the expandable metal frame; the expandable metal frame is configured to expand from a coiled orientation to an expanded orientation when the artificial heart valve is positioned at a treatment site in the heart; the expandable metal frame includes a plurality of angular hinge members and a plurality of axial longitudinal members; the angular hinge members and the axial longitudinal members are connected together to form a plurality of tissue-rowed grids in the expandable metal frame, wherein the grid rows are connected by the axial longitudinal members; when the expandable metal frame is in the expanded orientation, one or more of the axial longitudinal members have a longitudinal length of at least 10% of the longitudinal length of the expandable metal frame.

[0100] 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 includes a plurality of leaflets, each leaflet having an upper edge portion, a lower edge portion and two lateral flaps, wherein each lateral flap is connected to an adjacent lateral flap of another leaflet, and at least a portion of the leaflet structure is connected to an expandable metal frame.

[0101] 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, U-shaped staples, or adhesives.

[0102] Another and / or alternative non-limiting object of this disclosure is to provide an artificial heart valve for implantation in the heart, comprising an expandable metallic frame and at least one leaflet connected to the expandable metallic frame; the expandable metallic frame is configured to be coiled in an opening in a body passage and further expand from a coiled orientation to an expanded orientation; the expandable metallic frame has a distal end and a proximal end; the expandable metallic frame a) has an open mesh construction comprising a plurality of frame meshes, wherein the open mesh construction has high radial strength, b) is formed of a material with reduced recoil, thereby resulting in reduced recoil of the frame upon expansion, and c) can be coiled into a small diameter; the expandable metallic frame has two or more of the following properties: i) at least 70% to 100% of the expandable metallic frame is formed of a metallic alloy having a yield strength of at least 110 ksi, ii) at least 70% to 100% of the expandable metallic frame is formed of a metallic alloy having a yield strength of at least 35000 ksi. iii) A frame geometry having up to nine frame grids 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 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% to 100% of the expandable metal frame is 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 wherein the metal alloy is partially or completely formed from sintered metal powder; vi) When the expandable metal frame plastically deforms... The expandable metal frame has a perspective reduction of no more than 20%, vii) each grid in the grid includes at least one axial longitudinal member and at least two angular hinge members, and each of the angular hinge members includes a plurality of arcuate portions along the longitudinal length of the angular hinge member, viii) each grid in the grid includes at least one axial longitudinal member and at least two angular hinge members, and each of the angular hinge members includes a plurality of arcuate portions along the longitudinal length of the angular hinge member, and 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 includes a reinforcing coating.

[0103] Another and / or alternative non-limiting object of this disclosure is to provide an artificial heart valve for implantation in the heart, wherein one or more frame grids in the frame grid include at least two axial longitudinal members and at least two pairs of angular hinge members; each pair of angular hinge members includes at least two angular hinge members connected by a hinge joint; at least one of the axial longitudinal members extends from the distal end to the proximal end of the expandable frame; and wherein during expansion and / or curling of the expandable frame, the total longitudinal length of the frame grids of the frame does not exceed the longitudinal length of the axial longitudinal members.

[0104] Another and / or alternative non-limiting object of this disclosure is to provide an artificial heart valve comprising an expandable metallic frame and at least one leaflet connected to the expandable metallic frame; the expandable metallic frame is configured to be coiled in an opening in a body passage and further expand from a coiled orientation to an expandable orientation; the expandable metallic frame has a distal end and a proximal end; the expandable metallic frame includes a) an open mesh construction comprising a plurality of frame meshes and at least two rows of frame meshes, and / or b) formed of a material having less than 6% recoil, thereby resulting in reduced recoil of the expandable metallic frame when expanding from a coiled orientation to an expandable orientation; the expandable metallic frame has two or more of the following properties: i) at least 70% to 100% of the expandable metallic frame is formed of a metallic alloy having a yield strength of at least 110 ksi, ii) at least 70% to 100% of the expandable metallic frame is formed of a metallic alloy having a yield strength of at least 35000 ksi. iii) A frame geometry having a maximum of nine frame grids per horizontal row; iv) At least 70% to 100% of the expandable metal frame is formed of a metal alloy containing rhenium, 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) The expandable metal frame is formed of a material having no more than 5% recoil when the expandable metal frame undergoes plastic deformation; vi) When the expandable metal frame... When the frame undergoes plastic deformation, the expandable metal frame has a perspective shortening of no more than 20%; vii) the expandable metal frame is formed of a metal alloy having an elongation of at least 20%; and / or viii) each grid in the grid includes at least one axial longitudinal member and at least two angular hinge members, wherein each angular hinge member includes a plurality of arcuate portions along the longitudinal length of the angular hinge member, and wherein one or more axial longitudinal members have a continuous linear shape of at least 80% of the longitudinal length of the axial longitudinal member.

[0105] Another and / or alternative non-limiting object of this disclosure is to provide an artificial heart valve wherein one or more frame grids in a frame grid include at least two axial longitudinal members and at least two angular hinge members; each angular hinge member includes a first arm and a second arm connected to a hinge joint; the hinge joint has an arcuate or semicircular portion; each axial longitudinal member has a continuous linear shape of at least 90% of the longitudinal length of the axial longitudinal member.

[0106] Another and / or alternative non-limiting object of this disclosure is to provide an artificial heart valve wherein at least one axial longitudinal member in the row of frame grids is aligned along the same longitudinal axis to form an aligned set of axial longitudinal members, and the aligned set of axial longitudinal members extends fully from the distal end to the proximal end of the expandable metal frame; and wherein during the expansion and / or curling of the expandable metal frame, the total longitudinal length of each frame grid in the row of frame grids does not exceed the longitudinal length of each axial longitudinal member in the axial longitudinal member of the frame grid.

[0107] Another and / or alternative non-limiting object of this disclosure is to provide an artificial heart valve wherein one or more of the angular articulated members include one or more independent radii across their longitudinal length.

[0108] 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 articulated members is greater than or equal to the sum of the longitudinal lengths of the axial longitudinal members.

[0109] Another and / or alternative non-limiting object of this disclosure is to provide an artificial heart valve wherein the longitudinal length of the expandable frame is equivalent to the longitudinal length of at least one of the aligned axial longitudinal members during expansion and curling of the expandable frame.

[0110] Another and / or alternative non-limiting object of this disclosure is to provide an artificial heart valve in which the longitudinal length between the proximal end of the expandable frame and the commissural attachment region on the expandable frame is constant during expansion and / or curling of the expandable frame.

[0111] Another and / or alternative non-limiting object of this disclosure is to provide an artificial heart valve that further includes synergistic alignment marks positioned in an expandable frame; the synergistic alignment marks are formed of the same material as the material used to form the expandable frame.

[0112] Another and / or alternative non-limiting object of this disclosure is to provide an artificial heart valve in which the angular hinge members in the frame grid of the same column and / or the same row of frame grid have the same longitudinal length.

[0113] Another and / or alternative non-limiting object of this disclosure is to provide an artificial heart valve in which the vertices of adjacently positioned frame grids in adjacent rows are aligned within 5% of the total longitudinal length of the angular articulated members.

[0114] Another and / or alternative non-limiting object of this disclosure is to provide an artificial heart valve in which the area of ​​each frame grid in the most distal row of frame grids on the expandable frame differs from the area of ​​each frame grid in the most proximal row of frame grids by no more than 20%.

[0115] Another and / or alternative non-limiting object of this disclosure is to provide an artificial heart valve wherein the material of the expandable frame is made at least in part of a metallic alloy comprising less than 1 wt% nickel and / or less than 0.1 wt% cobalt.

[0116] Another and / or alternative non-limiting object of this disclosure is to provide an artificial heart valve wherein an expandable metal frame includes a plurality of angular hinge members and a plurality of axial longitudinal members; the angular hinge members and the axial longitudinal members are connected together to form a plurality of grids arranged in rows within the expandable metal frame; each grid includes at least one axial longitudinal member and at least two angular hinge members; each angular hinge member includes a plurality of arcuate portions along the longitudinal length of the angular hinge member; one or more axial longitudinal members have a continuous linear shape of at least 80% of the longitudinal length of the axial longitudinal member; and the expandable metal frame has a fluoroscopic shortening of no more than 20% when the expandable metal frame undergoes plastic deformation.

[0117] Another and / or alternative non-limiting object of this disclosure is to provide an artificial heart valve wherein one or more of the axial longitudinal members have a longitudinal length of 70-100% of the longitudinal length of the expandable metal frame when the expandable metal frame is in an expandable orientation.

[0118] Another and / or alternative non-limiting object of this disclosure is to provide an artificial heart valve wherein an expandable metallic frame includes a first strut row, a second strut row, and a third strut row; each of the first, second, and third strut rows includes a plurality of angular hinge members; each angular hinge member in the first strut row includes a first end and a second end, and wherein the first end of each angular hinge member is connected to one of the axial longitudinal members, and the second end of each angular hinge member is connected to a different axial longitudinal member; each angular hinge member in the second strut row includes a first end and a second end, and wherein multiple or all of the first ends of the plurality or all of the angular hinge members are connected to one of the axial longitudinal members. The angular hinge members in the first row are spaced apart from the angular hinge members in the second and third rows, and the angular hinge members in the third row are spaced apart from the angular hinge members in the second and third rows, respectively.

[0119] Another and / or alternative non-limiting object of this disclosure is to provide an artificial heart valve wherein an expandable metal frame includes a fourth strut row; the fourth strut row includes a plurality of angular hinge members; each of the angular hinge members in the first strut row includes a first end and a second end, and wherein one or all of the first ends of each angular hinge member are connected to one of the axial longitudinal members, and one or all of the second ends of each angular hinge member are connected to different axial longitudinal members; when the expandable metal frame is in an expanded orientation, the angular hinge members in the fourth strut row are spaced apart from the angular hinge members in the first, second, and third strut rows.

[0120] Another and / or alternative non-limiting object of this disclosure is to provide an artificial heart valve wherein a plurality of axial longitudinal members in the axial longitudinal members include a first axial longitudinal member segment and a second axial longitudinal member segment; the first axial longitudinal member segment and the second axial longitudinal member segment have different longitudinal lengths; each of the first axial longitudinal member segment and the second axial longitudinal member segment 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 angular hinge members in the angular hinge members; the top end of the second end of each of the second axial longitudinal member segments is connected to the bottom portion of one of the angular hinge members in the angular hinge members and / or the frame opening device in the frame opening device.

[0121] Another and / or alternative non-limiting object of this disclosure is to provide an artificial heart valve wherein a plurality of axial longitudinal members in the axial longitudinal members include a third axial longitudinal member segment; the longitudinal length of the third axial longitudinal member segment is different from the longitudinal length of the first axial longitudinal member segment and / or the second axial longitudinal member segment; the third axial longitudinal member segment includes a top end and a bottom end; the bottom end of each third axial longitudinal member segment is connected to a) the top end of the second axial longitudinal member segment and / or b) two angular hinge members in the angular hinge members; the top end of the third end of each second axial longitudinal member segment in the second axial longitudinal member segment is connected to two angular hinge members in the angular hinge members.

[0122] Another and / or alternative non-limiting object of this disclosure is to provide an artificial heart valve wherein each of the angular articulated members includes a centrally located arcuate portion and a first arm and a second arm extending from each side of the arcuate portion; the first arm of each of the angular articulated members has a first arm end; the second arm of each of the angular articulated members has a second arm end; each first arm end is connected to a) one of the axial longitudinal members and / or b) one of the frame opening devices; the longitudinal length of one or both of the first arm and the second arm of each of the angular articulated members is greater than the width or longitudinal length of the semicircular portion.

[0123] Another and / or alternative non-limiting object of this disclosure is to provide an artificial heart valve wherein each of the first and second arms includes one to three undulating portions.

[0124] Another and / or alternative non-limiting object of this disclosure is to provide an artificial heart valve wherein the expandable metal frame is formed partially or entirely of a refractory metal alloy or a metal alloy containing at least 15 atomic weight % rhenium or the refractory metal alloy or a metal alloy containing at least 5 atomic weight % rhenium; and wherein the metal alloy is not a shape memory alloy.

[0125] Another and / or alternative non-limiting object of this disclosure is to provide an artificial heart valve wherein the expandable metal frame has: a) being formed of a material having reduced recoil when bent, such that when the expandable metal frame is rolled to a rolled-up state, the expandable frame has recoil of no more than 5%; b) being formed of a material having reduced recoil when bent, such that when the expandable metal frame expands from a rolled-up state to an expanded state, the expandable frame has recoil of no more than 5%; and / or c) when the expandable metal frame expands from a rolled-up state, the percentage of fluoroscopic shortening is less than 20%.

[0126] Another and / or alternative non-limiting object of this disclosure is to provide an expandable artificial heart valve comprising an expandable metallic frame for implantation in a body channel; the expandable metallic frame being configured to be rolled up in an opening in the body channel and expand from a rolled-up orientation to an expandable orientation; the expandable metallic frame having a distal end and a proximal end; the expandable metallic frame comprising a plurality of frame grids and at least two rows of frame grids; the expandable metallic frame having two or more of the following characteristics: i) at least 70% to 100% of the expandable metallic frame is formed of a metallic alloy having a yield strength of at least 110 ksi, ii) at least 70% to 100% of the expandable metallic frame is formed of a metallic alloy having a yield strength of at least 35000 ksi. The following are descriptions of the expansionable metal frame: iii) a frame geometry having a maximum of nine frame grids per horizontal row; iv) at least 70% to 100% of the expandable metal frame being 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; v) at least 70% to 100% of the expandable metal frame being 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. vi) One or more metals comprising the group consisting of Mo, Cr, Co, Ni, Ti, Ta, Nb, Zr, and W, wherein the metal alloy is formed partly or entirely from sintered metal powder; vii) When the expandable metal frame undergoes plastic deformation, the expandable metal frame has a perspective shortening of no more than 20%; vii) Each grid in the grid comprises at least one axial longitudinal member and at least two angular hinge members, wherein each of the angular hinge members comprises a plurality of [missing information] along the longitudinal length of the angular hinge member. The bow-shaped portion, viii) each grid in the grid includes at least one axial longitudinal member and at least two angular hinge members, and wherein each angular hinge member includes a plurality of bow-shaped portions along the longitudinal length of the angular hinge member, and wherein one or more 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 includes a reinforcing coating, and wherein each angular hinge member optionally includes a plurality of bow-shaped portions along the longitudinal length of the angular hinge member, and wherein one or more axial longitudinal members optionally have a continuous linear shape of at least 80% of the longitudinal length of the axial longitudinal member; and wherein one or more frame grids in the frame grid optionally include at least two axial longitudinal members and at least two angular hinge members; each angular hinge member optionally includes a first arm and a second arm connected to a hinge joint; the hinge joint has a bow-shaped or semi-circular portion;Each of the axial longitudinal members has a continuous linear shape of at least 90% of the longitudinal length of the axial longitudinal member; and wherein at least one axial longitudinal member in the row frame grid is optionally aligned along the same longitudinal axis to form an aligned set of axial longitudinal members, and the aligned set of axial longitudinal members extends completely from the distal end of the expandable metal frame to the proximal end; and wherein during the expansion and / or curling of the expandable metal frame, the total longitudinal length of each frame grid in a row frame grid optionally does not exceed the longitudinal length of each axial longitudinal member in the axial longitudinal member of the frame grid; and wherein one or more angular hinge members in the angular hinge members optionally include one or more spanning their longitudinal length. Multiple independent radii; and wherein the sum of the longitudinal lengths of the angular hinge members is optionally greater than or equal to the sum of the longitudinal lengths of the axial longitudinal members; and wherein the longitudinal length of the expandable frame is optionally equivalent to the longitudinal length of at least one of the aligned axial longitudinal members during the expansion and curling of the expandable frame; and wherein the longitudinal length between the proximal end of the expandable frame and the engagement attachment area on the expandable frame is optionally constant during the expansion and / or curling of the expandable frame; and wherein the expandable frame optionally includes engagement alignment marks positioned in the expandable frame; the engagement alignment marks are optionally formed of the same material as the material used to form the expandable frame; and wherein the material used to form the engagement alignment marks is optionally of a material having a radius greater than 10. The metal has a density of mg / cm³; and wherein the alignment mark is optionally attached to the joining attachment area; and wherein the farthest row of frame grids on the expandable frame optionally includes an odd number of frame grids; and wherein the angular hinge members in the frame grids of the same column and / or the same row of frame grids optionally have the same longitudinal length; and wherein the vertices of adjacently positioned frame grids in adjacent rows are optionally aligned within 5% of the total longitudinal length of the angular hinge members; and wherein the area of ​​each frame grid in the farthest row of frame grids on the expandable frame optionally differs from the area of ​​each frame grid in the nearest side frame grid by no more than 20%; and wherein the material of the expandable frame is optionally made of a metal alloy containing less than 1 wt% nickel and / or less than 0.1 wt% cobalt; and wherein the expandable frame is optionally formed of a refractory metal alloy or a metal alloy containing at least 5 atomic weight percent (atomic weight%) or atomic weight percent (atomic weight%) rhenium (e.g., 5-99 atomic weight percent rhenium and all values ​​and ranges therebetween); and wherein the frame optionally includes a reinforcing coating;Furthermore, the expandable metal frame is optionally formed partially or entirely 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 wherein the metal alloy is formed partially or entirely of metal powder sintered together.

[0127] These and other advantages will become apparent to those skilled in the art upon reading and following this specification. Attached Figure Description

[0128] Non-limiting and non-exhaustive embodiments are described with reference to the accompanying drawings, wherein, unless otherwise specified, the same reference numerals refer to the same parts in the various views. The size and relative position of the 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. Specific shapes of the drawn elements have been selected for easy identification in the drawings. Reference can now be made to the accompanying drawings, which illustrate various embodiments of this disclosure that can be taken in physical form and in certain arrangements of parts and portions, wherein: Figure 1A It is based on the illustration of TAV disclosed herein.

[0129] Figure 1B It is part of the existing technology conduit.

[0130] Figures 1C to 1E A typical TAVR procedure for inserting a TAV into a heart valve is demonstrated.

[0131] Figure 2 yes Figure 1A The diagram of the TAV shows the features of the axial longitudinal members and angular hinge members of the frame.

[0132] Figure 3 This is a front view of the frame of the TAV in an expanded state according to this disclosure.

[0133] Figure 4 This is a front view of the flat frame of the TAV in an expanded state according to this disclosure.

[0134] Figure 5 This is a front view of a flat frame of a TAV in a curled or unexpanded state, according to this disclosure.

[0135] Figure 6A This is a front view of another flat frame of the TAV in an expanded state, according to this disclosure.

[0136] Figure 6B Is in Figure 6A A front view of a flat frame in its expanded state, including the frame's unrestricted dimensions.

[0137] Figures 6C to 6E It demonstrates the various features and structure of the TAV framework.

[0138] Figure 7 It is a table listing the comparative yield strength and modulus of various metal alloys.

[0139] Figure 8 It is a graph comparing the radial strength of a frame made of MoRe alloy with that of a frame made of standard CoCr alloy.

[0140] Figure 9 It is a graph showing the recoil of several different metal alloys.

[0141] Figure 10 This is a diagram comparing the fit of a metal strip or wire formed from a refractory metal alloy to the shape of a mold surface with the fit of a CoCr alloy metal strip or wire to the same mold surface.

[0142] Figure 11 A and Figure 11 B is a diagram comparing the fit of a TAV frame formed of a refractory metal alloy expanded in a non-circular aortic valve including calcium deposits with that of a similarly shaped and constructed TAV frame formed of a CoCr alloy expanded in the same non-circular aortic valve. It shows that due to the increased fit of the frame formed of the refractory metal alloy compared to the frame formed of the CoCr alloy, the paravalvular leak (PVL) of the TAV with the frame formed of the CoCr alloy is greater than the PVL of the TAV with the frame formed of the CoCr alloy.

[0143] Figure 12 A to Figure 12 C shows the stress versus area reduction percentage curves for TiAlV alloys, CoCr alloys, and MoRe alloys.

[0144] Figure 13 It is a graph showing the differences in stiffness and yield strength among MoRe alloys, CoCr alloys, and TiAlV alloys.

[0145] Figures 14A to 14C It is a graph showing the strength and fatigue ductility of TiAlV alloy, CoCr alloy and MoRe alloy.

[0146] Figure 15 The hydrophilicity of MoRe alloys, CoCr alloys, and TiAlV alloys was demonstrated. Detailed Implementation

[0147] A more complete understanding of the articles of manufacture / apparatus, processes, and components disclosed herein can be obtained by referring to the accompanying drawings. These drawings are merely schematic representations for the convenience and ease of illustrating this disclosure and are therefore not intended to indicate the relative size and dimensions of the apparatus or its components and / or to define or limit the scope of exemplary embodiments.

[0148] Although specific terms are used in the following description for clarity, these terms refer only to the specific structures of the selected embodiments used for illustration in the drawings and are not intended to limit or restrict the scope of this disclosure. In the drawings and the following description, it should be understood that the same numerical designations refer to components having the same function.

[0149] Unless the context clearly indicates otherwise, the singular forms “a”, “an”, and “the” contain plural indicators.

[0150] As used in the specification and claims, the term "comprising" may include embodiments of "consisting of" and "substantially consisting of". The terms "comprise(s)", "include(s)", "having", "has", "can", "contain(s)", and variations thereof, as used herein, are intended to be open-ended transitional phrases, terms, or words that require the presence of a specified ingredient / step and permit the presence of other ingredients / steps. However, such descriptions should be interpreted as also describing the composition or process as "consisting of the listed ingredients / steps" and "substantially consisting of the listed ingredients / steps", which allows for the presence of only the specified ingredient / step, and any unavoidable impurities that may result therefrom, and excludes other ingredients / steps.

[0151] The numerical values ​​in the specification and claims of this application should be understood to include the same numerical values ​​as when reduced to the same number of significant figures, and the differences from said values ​​are less than the experimental errors of conventional measurement techniques belonging to the type described in this application for determining values.

[0152] All ranges disclosed herein include the listed endpoints and can be combined independently (e.g., the range “2 g to 10 g” includes the endpoints 2 g and 10 g as well as all intermediate values).

[0153] The terms “about” and “approximately” can be used for any numerical value that can vary without altering the fundamental function of that value. When used with a range, “about” and “approximately” also disclose a range defined by the absolute values ​​of the two endpoints; for example, “about 2 to about 4” also discloses a range of “2 to 4”. Typically, the terms “about” and “approximately” can refer to plus or minus 10% of the number referred to.

[0154] Unless otherwise expressly stated, the percentage of an element shall be assumed to be the weight percentage of the element.

[0155] While exemplary embodiments of the disclosed methods may be described in a specific order for ease of presentation, it should be understood that the disclosed embodiments may include an order of operations other than the specific order disclosed. For example, in some cases, the operations described in order may be rearranged or performed simultaneously. Furthermore, the descriptions and disclosures provided in association with a particular embodiment are not limited to that embodiment and may be applied to any of the disclosed embodiments.

[0156] For simplicity, the accompanying drawings may not show the various ways in which the systems, methods, and apparatuses disclosed herein can be used in conjunction with other systems, methods, and apparatuses (which can be readily discerned by those skilled in the art based on this disclosure). Additionally, the description sometimes uses terms such as “produce” and “provide” to describe the disclosed methods. These terms are abstract concepts of actual operations that can be performed. The actual operations corresponding to these terms may vary from specific implementation to specific implementation and can be readily discerned by those skilled in the art based on this disclosure.

[0157] Now for reference 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 (e.g., an aortic valve, etc.) of the heart H. The artificial heart valve 100 can be implanted in the annulus of an autologous aortic valve A; however, the artificial heart valve 100 can also be configured to be implanted with other valves of the heart. Although the medical device shown is a TAV, this disclosure is not limited to a TAV or any other heart valve replacement.

[0158] Now for reference Figure 1A The artificial heart valve 100 typically includes a frame 110 formed by a plurality of axial longitudinal members and angular hinge members 112, 114, a strut connector 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 entirely formed of a rhenium-containing metal alloy. The artificial heart valve 100 has a “lower” end 120 and an “upper” end 130, wherein the lower end 120 of the artificial heart valve 100 is the inflow end, and the upper end 130 of the artificial heart valve 100 is the outflow end.

[0159] Frame 110 may optionally be coated with a polymeric material (e.g., silicone, PTFE, ePTFE, polyurethane, polyolefin, hydrogel, biomaterial [e.g., pericardium or biopolymers such as collagen, gelatin, or hyaluronic acid derivatives], etc.). This coating may be used to partially or completely encapsulate one or more vertically extending axial longitudinal members 112 and / or non-perpendicular angular hinge members 114 on frame 110 and / or partially or completely fill one or more openings between non-perpendicular angular hinge members 114 and / or vertically extending axial longitudinal members 112.

[0160] The inner skirt 300 can be formed from a variety of flexible materials, such as polymers (e.g., polyethylene terephthalate (PET), polyester, nylon, Kevlar, silicone, etc.), composite materials, metals, fabric materials, etc. In one non-limiting embodiment, the material used to partially or completely form the inner skirt 300 can be substantially inelastic (i.e., substantially non-stretchable and non-compressible). In another non-limiting embodiment, the material used to partially or completely form the inner skirt 300 can be a stretchable and / or compressible material (e.g., silicone, PTFE, ePTFE, polyurethane, polyolefin, hydrogel, biomaterials [e.g., pericardium or biopolymers such as collagen, gelatin, or hyaluronic acid derivatives], etc.). The inner skirt 300 can optionally be formed from a combination of fabric or woven materials coated with flexible or stretchable and / or compressible materials to provide additional structural integrity to the inner skirt 300. The dimensions, construction, and thickness of the inner skirt 300 are non-limiting (e.g., thicknesses from 0.1 to 20 mils and all values ​​and ranges therebetween). The inner skirt 300 can be secured to the inside and / or outside of the frame 110 in various ways (e.g., stitching, clips, clamping devices, etc.).

[0161] The inner skirt 300 can be used to 1) at least partially seal and / or prevent paravalvular 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 curling of the artificial heart valve 100, and 4) at least partially protect one or more leaflets of the leaflet structure 200 from damage during operation of the artificial heart valve 100 in the heart H.

[0162] The artificial heart valve 100 may optionally include an outer skirt or sleeve (not shown) positioned at least partially around an outer region of the frame 110. The outer skirt or sleeve (when in use) is typically positioned completely around a portion of the outer exterior of the frame 110. Typically, 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; however, this is not required. The outer skirt can be attached to the frame 110 by various methods, such as sutures, adhesives, fusion bonding, clamping devices, etc. At least a portion of the outer skirt may optionally be located on the inner surface of the frame 110; however, this is not required. Typically, the outer skirt is formed of a material that is more flexible and / or more compressible than the inner skirt 300; however, this is not required. The outer skirt may be formed of a variety of stretchable and / or compressible materials, such as silicone, PTFE, ePTFE, polyurethane, polyolefins, hydrogels, biomaterials [e.g., pericardium or biopolymers such as collagen, gelatin, or hyaluronic acid derivatives], etc. The outer skirt may optionally be formed from a combination of fabric or woven materials coated with a stretchable and / or compressible material to provide additional structural integrity. The dimensions, construction, and thickness of the outer skirt are not limiting. The thickness of the outer skirt is typically from 0.1 to 20 mils (and all values ​​and ranges therebetween).

[0163] The leaflet structure 200 may be attached to the frame 110 and / or the inner skirt 300. The connection methods used to secure the leaflet structure 200 to the frame 110 and / or the inner skirt 300 are not limited (e.g., sutures, fusion bonding, adhesives, clamping devices, etc.). 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 various other suitable natural or synthetic materials.

[0164] The leaflet structure 200 may consist of two or more leaflets (e.g., 2, 3, 4, 5, 6, etc.). In a non-limiting arrangement, the leaflet structure 200 includes three leaflets arranged in a tricuspid configuration of collapse. The size, shape, and construction of one or more leaflets of the leaflet structure 200 are non-limiting. In a non-limiting arrangement, the leaflets have substantially the same shape, size, construction, and thickness.

[0165] Two or more leaflets of the leaflet structure 200 may optionally be fixed to each other on their adjacent sides to form a junction (edge ​​of leaflet confluence) of the leaflet structure 200. The leaflet structure 200 may be fixed to the frame 110 and / or the inner skirt 300 by various connection methods (e.g., sutures, adhesives, fusion bonding, clamping devices, etc.).

[0166] 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) inhibit or prevent tearing or other types of damage to the leaflets.

[0167] The artificial heart valve 100 is configured to be radially collapsible to a collapsed or coiled state for introduction into the body via a delivery catheter. Figure 1B Furthermore, the artificial heart valve can be radially expanded to an expanded state to allow implantation of the artificial heart valve 100 at a desired location in the heart H (e.g., aortic valve A, etc.). Figure 1E The frame of the artificial heart valve 100 is made of a plastic expandable material (e.g., a refractory metal alloy) that allows the frame to be rolled into a smaller profile for delivery and expansion of the artificial heart valve 100 using an expansion device. Figure 1B A universal frame F of an artificial heart valve is shown, coiled on a universal balloon catheter C. A balloon B on the balloon catheter C can be used to expand the frame F from a coiled state to an expanded state. Various types of coiling devices and techniques can be used to coil the artificial heart valve onto the balloon delivery catheter. The process of coiling an artificial heart valve using a coiling device is known in the art and will not be described herein. Damage to the leaflets of the leaflet structure should be avoided during the coiling process.

[0168] like Figures 1C to 1E As shown, once the artificial heart valve 100 is coiled onto the balloon B of the balloon catheter C, the balloon catheter C is inserted through the blood vessel and reaches the location in the heart H, where the artificial heart valve 100 will be deployed (see...). Figure 1C At the treatment site, balloon B on balloon catheter C is inflated, thereby expanding and securing the artificial heart valve 100 in valve region A of heart H (see...). Figure 1D Afterward, balloon B was deflated, and balloon catheter C was removed from the patient (see...). Figure 1E ).

[0169] Now for reference Figures 3 to 6EA novel frame 400 for an artificial heart valve 100 is shown. The frame 400 is configured to curl onto a delivery catheter C, allowing the curled artificial heart valve 100 to be inserted into a heart valve. The frame 400 may optionally be configured such that the artificial heart valve 100 can be curled to a diameter less than 22 Fr; however, this is not required. Thus, the artificial heart valve 100 including the frame 400 according to this disclosure may optionally be configured such that the artificial heart valve 100 can be inserted into smaller-sized heart valves that could not previously be handled with prior art artificial heart valves. As will be understood, the size and construction of the artificial heart valve 100 according to this disclosure may be designed for insertion into heart valves larger than 22 Fr.

[0170] Now for reference Figures 3 to 5 This illustrates a non-limiting embodiment of the framework 400 according to the present disclosure. Figures 6A to 6E Another non-limiting embodiment according to framework 400 of this disclosure is shown. This will be discussed in more detail below. Figures 3 to 5 The frame 400 shown includes four rows of angular hinge members 410 and a grid group including nine grids 480, and Figures 6A to 6E The frame 400 shown includes three rows of angular hinge members 410 and a grid group including six grids 480.

[0171] Refer again Figures 3 to 5 The radially retractable and expandable frame 400 includes a plurality of angular hinge members 410, a plurality of axial longitudinal members 450, and a plurality of frame opening devices 460, wherein the angular hinge members 410, the plurality of axial longitudinal members 450, and the frame opening devices 460 are connected together to form a plurality of grids 480 in the frame 400. The angular hinge members 410 have a first end 412 and a second end 414 connected to either the axial longitudinal members 450 or the frame opening devices 460.

[0172] The frame opening device 460 is located on the top portion of the frame 400. Each frame opening device 460 may include a lower frame opening 462 and optional upper frame openings 464, 466.

[0173] like Figure 4 As shown, the frame 400 is formed by three sets of grids, each set comprising nine grids 480. Figure 6A and Figure 6B As shown, the frame comprises two sets of grids, and each set contains nine grids. Figure 4 As shown, the number, shape, and size of the grids 480 in each of the three grid groups are mirror images of each other and have the same shape and size.

[0174] Refer again Figures 3 to 5Multiple axial longitudinal members 450 are formed by three axial longitudinal member segments 452, 454, and 456, and some axial longitudinal members 450 are formed by two axial longitudinal member segments. Figures 6A to 6E The frame 400 shown includes multiple axial longitudinal members or axial longitudinal components, some of which are formed by two axial longitudinal member segments, and some of which are formed by a single axial longitudinal member segment. Axial longitudinal members 450 may be formed from a single piece of material or from multiple pieces of material already joined together (e.g., by solder joints, welded joints, adhesive joints, mechanical joints, etc.). The axial longitudinal member segments forming each of the axial longitudinal members 450 are generally aligned along the longitudinal axis of the axial longitudinal member 450. The thickness or cross-sectional area of ​​each of the axial longitudinal members 450 along the longitudinal axis of the axial longitudinal member may be constant or variable. The lower axial longitudinal member segment 452 may have a greater thickness or cross-sectional area than the upper axial longitudinal member segment 456. The middle axial longitudinal member segment 454 may have a greater thickness or cross-sectional area than the upper axial longitudinal member segment 456. The lower axial longitudinal member segment 452 may have a substantially the same thickness or cross-sectional area as the middle axial longitudinal member segment 454. As can be understood, the lower axial longitudinal member segment 452 may have a different thickness or cross-sectional area than the middle axial longitudinal member segment 454. The cross-sectional shape of each axial longitudinal member 450 along its longitudinal length may be constant or variable. The longitudinal lengths of the axial longitudinal member segments may be the same or different. The lower axial longitudinal member segment 452 may have a longitudinal length less than the longitudinal length of either or both of the middle axial longitudinal member segment 454 and the upper axial longitudinal member segment 456, and the middle axial longitudinal member segment 454 may have a longitudinal length greater than either or both of the lower axial longitudinal member segment 452 and the upper axial longitudinal member segment 456. Figure 4 As shown, the lower axial longitudinal member segment 452 has the shortest longitudinal length, and the middle axial longitudinal member segment 454 has the longest longitudinal length.

[0175] like Figure 3 and Figure 4As shown, frame 400 includes angular hinge members 410 in a first row 420, a second row 422, a third row 424, and a fourth row 426. The first row 420 is the bottom row, and the fourth row 426 is the top row. The angular hinge members 410 in the first row 420 are identical in shape, size, and / or construction. The angular hinge members 410 in the second row 422 are identical in shape, size, and / or construction. The angular hinge members 410 in the third row 424 are identical in shape, size, and construction. The angular hinge members 410 in the fourth row 426 are identical in shape, size, and / or construction, while the angular hinge members 410 in the fourth row 436 are different. (See again) Figure 4 The angular hinge member 410 on the fourth row 426 (where the first end 412 or the second end 414 of the angular hinge member 410 is connected to the frame opening device 460) has a different shape, size and / or construction than the angular hinge member 410 on the fourth row 426, wherein both the first end 412 and the second end 414 of the angular hinge member 410 are connected to the axial longitudinal member 450.

[0176] Refer again Figures 3 to 6E Each of the angular hinge members 410 is formed by a centrally located arcuate or semicircular portion 430 and a first arm 432 and a 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 undulations 440, 442. Figure 4 As shown, the first arm 432 includes a first undulation 440 and a second undulation 442, wherein the first undulation 440 is closer to the semicircular portion 430 than the second undulation 442. Similarly, the second arm 434 includes a first undulation 440 and a second undulation 442, wherein the first undulation 440 is closer to the semicircular portion 430 than the second undulation 442. Thus, each angular hinge member 410 includes at least three undulations along its longitudinal length. Figure 4 As shown, each angular hinge member 410 includes five undulations along the longitudinal length of the angular hinge member 410.

[0177] Best of all Figure 4 As shown, each of the first arm 432 and the second arm 434 of all angular hinge members 410 includes two undulations; however, the shape and size of the undulations of two or more rows of angular hinge members 410 are different; however, this is not necessary. Also as Figure 4As shown, the shape, size, and position of the undulations on the angular hinge members 410 in each row are generally the same. For example... Figure 4 As shown, the shape and size of the undulations of the angular hinge members 410 on the first row 420 and the second row 422, as well as the positions of the undulations, are the same or very similar (e.g., the size difference is less than 5%). Also as... Figure 4 As shown, the shape and size of the undulations on the angular hinge member 410 in the third row are different from those in the first row 420, the second row 422, and the fourth row 426. Furthermore, the shape and size of the undulations on the angular hinge member 410 in the fourth row are different from those in the first row 420, the second row 422, and the third row 424. In another non-limiting embodiment, for a plurality of angular hinge 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 size difference is less than 5%). In a non-limiting configuration, the angular hinge member 410 forming the angular hinge member 410 of the first row 420 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 angular hinge member 410 forming the second row 422 has a first arm 432 and a second arm 434, wherein the first arm 432 and the second arm 434 have the same length, shape, and size. In another non-limiting configuration, the angular hinge member 410 forming the third row 424 has a first arm 432 and a second arm 434, wherein the first arm 432 and the second arm 434 have the same length, shape, and size. In another non-limiting configuration, the angular hinge member 410 forming the fourth row 424 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 exactly the same. In another non-limiting configuration, the angular hinge members 410 for 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 or very similar (e.g., the size difference is less than 5%) for the angular hinge members 410 for the first row 420 and the second row 422. In another non-limiting configuration, the angular hinge members 410 on each of 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 center point of the semicircular portion 430 is located at ±5% (and all values ​​and ranges therebetween) of the midpoint between the adjacent positioned axial longitudinal members 450.

[0178] Refer again Figures 3 to 6EThe spacing between the angular hinge members 410 of adjacent positioning rows 420, 422, 424, and 426 can be the same or different. In a non-limiting embodiment, the spacing between the angular hinge members 410 of adjacent positioning rows (e.g., the first and second rows, the second and third rows, the third and fourth rows, etc.) is different. Figure 4 As shown, the distance between the semicircular portions 430 of the angular hinge members 410 in the first row 420 and the second row 422 is greater than the distance between the semicircular portions 430 of the angular hinge members 410 in the second and third rows 422 and 424, and the distance between the first ends 412 of the angular hinge members 410 in the first row 420 and the second row 422 is less than the distance between the first ends 412 of the angular hinge members 410 in the second row 422 and the third row 424, and the distance between the second ends 414 of the angular hinge members 410 in the first row 420 and the second row 422 is less than the distance between the second ends 414 of the angular hinge members 410 in the second row 422 and the third row 424. Also... Figure 4 As shown, the semicircular portions 430 of the first row 420 and second row 422 angularly oriented towards the top of the frame, and the semicircular portions 430 of the third row 424 and fourth row 425 angularly oriented towards the bottom of the frame. Thus, the semicircular portions 430 of the second row 422 and third row 424 angularly oriented towards the top of the frame face each other. Also as... Figure 4 As shown, the distance between the semicircular portions 430 of the angular hinge members 410 in the third row 424 and the fourth row 426 is greater than the distance between the semicircular portions 430 of the angular hinge members 410 in the first row 420 and the second row 422, and the distance between the first ends 412 of the angular hinge members 410 in the third row 424 and the fourth row 426 is greater than the distance between the first ends 412 of the angular hinge members 410 in the first row 420 and the second row 422, and the distance between the second ends 414 of the angular hinge members 410 in the third row 424 and the fourth row 426 is greater than the distance between the second ends 414 of the angular hinge members 410 in the first row 420 and the second row 422. Also... Figure 4 As shown, the distance between the semicircular portions 430 of the angular hinge members 410 in the third row 424 and the fourth row 426 is greater than the distance between the semicircular portions 430 of the angular hinge members 410 in the second row and the third row 422 and 424. The distance between the first ends 412 of the angular hinge members 410 in the third row 424 and the fourth row 426 is less than the distance between the first ends 412 of the angular hinge members 410 in the second row 422 and the third row 424. The distance between the second ends 414 of the angular hinge members 410 in the third row 424 and the fourth row 426 is less than the distance between the second ends 414 of the angular hinge members 410 in the second row 422 and the third row 424.

[0179] like Figures 6A to 6E As shown, the spacing between the angular hinge members in adjacent rows can be different.

[0180] Now for reference Figures 3 to 6E The frame opening device 460 is located between the angular hinge members 410 of the third row 424 and the fourth row 426. It is understood that one or more frame opening devices 460 may be located on other areas of the frame 400. The frame opening device 460 may optionally serve as a fixing location for one or more leaflet structures 200; however, it is understood that one or more frame opening devices 460 may optionally serve as a fixing location for other structures (e.g., leaflets, inner skirts, outer skirts, etc.), and / or as an indicator of the orientation and / or position of the frame 400 in the body passage or heart valve. Alternatively, an orientation structure 490 may be included in the frame 400. Figures 3 to 6E As shown, each frame opening device 460 includes a first frame opening support 470 and a second frame opening support 472, which form a lower frame opening 462 and optionally upper frame openings 464, 466 therebetween. The size and shape of the lower frame opening 462 and the optional upper frame openings 464, 466 are not limited. Figure 3 and Figure 4 As shown, the lower frame opening 462 has a generally rectangular shape and extends only partially along the longitudinal length of the frame opening device 460. As will be understood, the lower frame opening 462 may have other shapes and sizes. In a non-limiting configuration, each frame opening device in the frame opening device 460 includes a lower frame opening 462, and all lower frame openings 462 have the same or very similar (e.g., size difference less than 5%) shape and size. In a non-limiting embodiment, one or both of the first frame opening support 470 and the second frame opening support 472 a) have a longitudinal axis parallel to the longitudinal axis of the axial longitudinal member 450 to which the bottom of the frame opening device 460 extends, and / or b) have a longitudinal axis offset from the longitudinal axis of the axial longitudinal member 450 to which the bottom of the frame opening device 460 extends. Figure 3 and Figure 4 As shown, both the first frame opening support 470 and the second frame opening support 472 a) have a longitudinal axis parallel to the longitudinal axis of the axial longitudinal member 450 to which the bottom of the frame opening device 460 is connected, and b) have a longitudinal axis connection offset from the longitudinal axis of the axial longitudinal member 450 to which the bottom of the frame opening device 460 is connected. The longitudinal length of one or both of the first frame opening support 470 and the second frame opening support 472 may be equal to or less than the longitudinal length of the axial longitudinal member segment located near the first frame opening support 470 and the second frame opening support 472. Figure 4As shown, the longitudinal length of the first frame opening support 470 and the second frame opening support 472 is approximately the same as the length of the axial longitudinal member segment 456.

[0181] like Figure 4 As shown, the end of the fourth row 426 angular hinge member 410 that connects to the first arm 432 or the second arm 434 of the frame opening device 460 can optionally be configured to be angled downwards, and the other end of the first arm 432 or the second arm 434 of the angular hinge member 410 that connects to the axial longitudinal member segment is configured to be angled upwards. Figure 4 As shown, the ends of the first arm 432 and the second arm 434 of the angular hinge member 410, which connects to the first row 440, the second row 422, and the third row 424 of the axial longitudinal member segment, are all angled in the same direction. Figure 4 As shown, when the frame is in an expansion orientation, the angle β of the angular hinge member 410 relative to the axial longitudinal member 450 is typically 25-60° (and all values ​​and ranges therebetween). A similar arrangement for the connection of the angular hinge member to the axial longitudinal member or the frame opening device is shown in... Figures 6A to 6E As shown in the image.

[0182] Now for reference Figure 3 and Figure 4 The frame opening device 460 may optionally include one or more optional upper frame openings 464, 466. The one or more optional upper frame openings 464, 466 are generally positioned above the lower frame opening 462. Typically, the one or more optional upper frame openings 464, 466 have a smaller cross-sectional area or size than the lower frame opening 462; however, this is not required. Figure 3 and Figure 4 As shown, two or more 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 the correct positioning of the frame 400 and the artificial heart valve 100 in the heart. In one specific non-limiting configuration, each of the one or more optional upper frame openings 464, 466 has a different shape. Figure 3 As shown, the two frame opening devices in the frame opening device 460 include two upper frame openings 464 and 466 of different shapes, and the other frame opening devices 460 do not have upper frame openings. As shown in Figure 6, the frame 400 does not have an upper frame opening.

[0183] The top portion of each frame opening device in the frame opening device 460 may optionally include a top mark 468. The shape and size of the top mark 468 (when used) are not limiting. Figure 3 , Figure 4As shown in Figure 6, the top mark 468 has the same or very similar shape and size (e.g., the size difference is less than 5%). The top mark 468 can be used as a marker to facilitate the correct positioning of the frame 400 and the artificial heart valve 100 in the heart. One or more top marks 468 (when used) can also be used, or alternatively, to enable one or more components of the artificial heart valve 100 (e.g., leaflets, inner skirt, outer skirt, etc.) to be attached to the frame 400. The top mark 468 can be formed of the same or different material as other parts of the frame 400.

[0184] The non-limiting dimensions of a frame 400 formed of a metal alloy according to this disclosure and expandable to 26 mm may include: a) an axial longitudinal member 450 having a length of 18-28 mm (and all values ​​and ranges therebetween); b) a length of approximately 70-95 mm (and all values ​​and ranges therebetween) for the frame 400 in a flat state; c) an axial longitudinal member 450 having a width of approximately 0.2-0.7 mm (and all values ​​and ranges therebetween); d) an axial longitudinal member 450 having a depth of approximately 0.2-0.7 mm (and all values ​​and ranges therebetween); e) an angular hinge member 410 having a width of approximately 0.2-0.7 mm (and all values ​​and ranges therebetween); f) a frame 400 having a depth of approximately 0.2-0.7 mm. The angular hinge member 410 has a depth within the range of mm (and all values ​​and ranges therein), g) the adjacent axial longitudinal members 450 are spaced approximately 6-12 mm (and all values ​​and ranges therein), h) the number of grids 480 in each grid group can be 2-20 (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 hinge member can optionally be greater than one or more of the upper angular hinge members.

[0185] Figure 3 and Figure 4 The frame 400 is shown in its expanded position, and Figure 5 The frame 400 is shown in an unexpanded or curled position.

[0186] The frame 400 is formed partly or entirely of a refractory metal alloy or a metal alloy containing at least 15 atomic weight percent rhenium.

[0187] When the frame 110 of the artificial heart valve 100 is formed of a refractory metal alloy or a metal alloy containing at least 15 atomic weight percent rhenium, it can be rolled up to have a rolled outer diameter that is at least 5% and up to 33% smaller than that of a frame made of Co-Cr alloy of the same size, construction and shape (e.g., smaller 5% to 33% and all values ​​and ranges therein); b) smaller than that of a frame made of nitinol of the same size, construction and shape (e.g., smaller 5% to 40% and all values ​​and ranges therein); and / or c) smaller than that of a frame made of TiAlV alloy of the same size, construction and shape (e.g., smaller 5% to 40% and all values ​​and ranges therein).

[0188] Compared to frames for artificial heart valves made of stainless steel, Co-Cr alloys, TiAlV alloys, or NiTi alloys, frames 400 for artificial heart devices (e.g., TAVR, etc.) made of refractory metal alloys or metal alloys containing at least 15 atomic weight % rhenium have one or more improved properties or advantages, namely: 1) the outer diameter (OD) of a coiled artificial valve with a frame made of a refractory metal alloy or metal alloy containing at least 15 atomic weight % rhenium is smaller than the OD coiled diameter of a coiled artificial valve with the same frame size but made of Co-Cr alloys, TiAlV alloys, or NiTi alloys; 2) the strut joint width (e.g., the location where the end of an angular hinge member and / or an axial longitudinal member connects to another part of the frame) on a frame made of a refractory metal alloy or metal alloy containing at least 15 atomic weight % rhenium can be smaller than the strut joint width on a frame made of stainless steel, Co-Cr alloys, TiAlV alloys, or NiTi alloys, while still forming a shape similar to that of a frame made of stainless steel, Co-Cr alloys, TiAlV alloys, or NiTi alloys. 3) The width of the angular hinge members and / or axial longitudinal members on the frame formed of a refractory metal alloy or a metal alloy containing at least 15 atomic weight % rhenium may be smaller than that on the frame formed of stainless steel, Co-Cr alloy, TiAlV alloy or NiTi alloy, while still forming a frame as robust as the frame formed of stainless steel, Co-Cr alloy, TiAlV alloy or NiTi alloy; 4) The recoil of the frame formed of a refractory metal alloy or a metal alloy containing at least 15 atomic weight % rhenium after the frame has curled or after the frame has expanded is less than that of the frame with the same frame size but formed of stainless steel, Co-Cr alloy, TiAlV alloy or NiTi alloy; and / or 5) The perspective shrinkage of the frame formed of a refractory metal alloy or a metal alloy containing at least 15 atomic weight % rhenium after the frame has expanded is less than that of the frame with the same frame size but formed of stainless steel, Co-Cr alloy, TiAlV alloy or NiTi alloy. In one non-limiting configuration, the metal alloy used to partially or completely form the framework is formed from sintered metal powder. This type of sintered powder metal alloy differs from cast metal alloys. In another non-limiting configuration, the metal alloy used to partially or completely form the framework is formed from sintered metal powder, and the metal alloy has been cold-worked to increase its ductility.

[0189] When the frame expands from the curled state, such as Figures 3 to 6EThe frame construction shown results in little or no perspective shortening. Typically, the perspective shortening of the frame from a rolled-up state to an expanded state is 0-20% (and all values ​​and ranges in between), typically 0-15%, more typically 0-10%, and even more typically 0-5%. When the frame expands from a rolled-up state, the orientation and construction of the axial longitudinal member segments (e.g., 452, 454, 456) contribute to reducing perspective shortening. Similarly, when the frame is rolled up, the orientation and construction of the axial longitudinal member segments (e.g., 452, 454, 456) contribute to reducing perspective shortening. This reduced perspective shortening helps ensure that the artificial heart implant maintains its correct position in the treatment area when the frame expands from a rolled-up state. When the frame expands, the perspective shortening of the artificial heart implant results in a reduction in longitudinal length. This reduction in longitudinal length during frame expansion can lead to misalignment of the expanded artificial heart implant in the treatment 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 tissue surrounding the implanted artificial heart implant, d) shortened lifespan of the artificial heart implant, and / or e) plaque and / or calcium deposits forming around the artificial heart implant.

[0190] The strength of the refractory metal alloy used to partially or completely form the frame 400, or the metal alloy containing at least 15 atomic weight % rhenium, may optionally be greater than that of cobalt-chromium alloys, nickel-titanium alloys, or TiAlV alloys. Therefore, the width of the angular hinge members and / or axial longitudinal members and / or strut joints of the frame 400 may be made smaller than that of the frame formed by cobalt-chromium alloys, nickel-titanium alloys, or TiAlV alloys, thereby enabling the frame to be made smaller without sacrificing the strength of the frame.

[0191] like Figure 7Table 1 shows a comparison of the yield strength and Young's modulus (or elastic modulus) of MoRe alloys (e.g., 45-55 wt% Re and 45-55 wt% Mo) 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 alloys is at least twice that of the CoCr alloys (such as MP35N and L605) and the stainless steel alloys (such as 316L). Moreover, the Young's modulus of the MoRe alloys is at least 1.5 times that of the CoCr alloys (such as MP35N and L605) and the stainless steel alloys (such as 316L). In one non-limiting embodiment, the yield strength of 75%-100% (and all values ​​and ranges therebetween) of the metal alloy used to form the frame is at least 1.1 times (e.g., 1.1-4 times and all values ​​and ranges therebetween) the standard CoCr alloy, MP35N alloy, L605 alloy, standard SS alloy, and stainless steel 316L alloy. In another non-limiting embodiment, the Young's modulus of 75%-100% (and all values ​​and ranges therebetween) of the metal alloy used to form the frame (e.g., refractory metal alloy, refractory metal alloy containing at least 25 wt% rhenium, metal alloy containing at least 15 atomic wt% rhenium) is at least 1.1 times (e.g., 1.1-2.5 times and all values ​​and ranges therebetween) the standard CoCr alloy, MP35N alloy, L605 alloy, standard SS alloy, and stainless steel 316L alloy.

[0192] Now for reference Figure 8 The chart provides a comparison of radial forces for two frames of the same size and construction used for artificial heart valves, one of which is a MiRus™ frame made of MoRe alloy (e.g., 45-55 wt% Re and 45-55 wt% Mo), and the other is made of standard MP35N alloy. Figure 8 As shown, for frames with a diameter expanded to 25.75 mm, frames made of MoRe alloy exhibit greater radial strength than those made of standard MP35N alloy. Thus, the angular hinge members and / or axial longitudinal members of frames made of MoRe alloy can be manufactured thinner than those made of standard MP35N alloy, while still possessing the same or greater radial strength. Furthermore, the greater radial force provided by the metal alloy allows for a larger open grid size within the frame compared to prior art frames, and allows for a smaller curl profile compared to prior art frames.

[0193] When a frame undergoes plastic deformation (e.g., curling, expansion from a curled state, etc.), the recoil of materials used in frames made of refractory metal alloys or metal alloys containing at least 15 atomic weight % rhenium can be less than that of frames of the same size and construction made of cobalt-chromium alloys, nickel-titanium alloys, or TiAlV alloys. When a frame is curled or when it expands from a curled state, the recoil of refractory metal alloys or metal alloys containing at least 15 atomic weight % rhenium typically does not exceed 8% (e.g., 0-8% and all values ​​and ranges therebetween), typically does not exceed 5%, more typically does not exceed 3%, even more typically does not exceed 2%, and even more typically is less than 2%. Due to the low recoil, the minimum curled outer diameter of the curled frame can be obtained with only one curling cycle. Frames made of metal alloys with greater recoil typically require multiple curling processes to obtain the designed curled frame side.

[0194] like Figure 9 As shown, the curling of a frame formed of a) Co-Cr alloy (e.g., 35Co-35Ni-20Cr-10Mo) will recoil by 9% or more (e.g., 9-15% and all values ​​and ranges therein) after the radial curling force is removed from the frame, or the curling of a frame formed of a) titanium alloy (e.g., Ti-6Al-4V) will recoil by 6% or more (e.g., 6-10% and all values ​​and ranges therein) after the radial curling force is removed from the frame. Figure 9 Frames formed from MoRe alloys (e.g., 45-55 wt% Re and 45-55 wt% Mo) exhibit less than 2% recoil after coiling or expansion (e.g., 0.1-1.99% and all values ​​and ranges therebetween). Therefore, when the frame is formed from a metallic alloy with reduced recoil, the need to subject the frame to multiple coiling cycles or procedures can be eliminated, thereby a) reducing the incidence of frame damage, b) reducing the incidence of leaflet damage to the artificial heart valve, c) reducing the incidence of damage to the inner and / or outer skirts of the artificial heart valve, and / or d) reducing the incidence of damage to other components of the artificial heart valve (e.g., balloon damage to the catheter, damage to one or more components of the catheter, etc.). The reduced recoil after expansion of a frame formed from a refractory metallic alloy or a metallic alloy containing at least 15 atomic wt% rhenium results in a better fit of the frame to the orifice size in the heart. Therefore, the increased EOA (effective orifice area) leads to a reduction in paravalvular leakage (i.e., leakage caused by the space between the patient's natural heart tissue and the valve replacement). Larger backlash in frames formed of Co-Cr or Ti alloys leads to a decrease in EOA and an increase in paravalvular leakage around the artificial heart valve.

[0195] Figure 10Two different wires formed from CoCr and refractory metals such as MoRe are shown to demonstrate the bending fit of the two types of wires. When the frame of an artificial heart implant expands, the angular hinge members and / or axial longitudinal members of the frame undergo plastic deformation (e.g., typically outward deformation) due to the expansion of the inflatable balloon or from some other expansion device. Typically, the treatment site in which the artificial heart implant expands is not perfectly cylindrical, nor does it have a perfectly circular cross-sectional shape. The treatment area is often damaged and / or includes plaque, calcium deposits, and / or other materials that result in a non-cylindrical shape or a non-circular cross-sectional shape (e.g., previously implanted medical devices, etc.). Therefore, an artificial heart implant frame that can better fit irregular shapes in the treatment site allows for a better fit of the artificial heart implant to the treatment area and can lead to a reduction in paravalvular leakage or other types of leakage around the periphery of the expanded artificial heart implant. Figure 10 This demonstrates that when angular hinge members and / or axial longitudinal members of frames of the same size and construction, formed of MoRe or Co-Cr alloys, are subjected to the same bending force, MoRe angular hinge members and / or axial longitudinal members conform to the ideal bending shape IBS better than Co-Cr alloy angular hinge members and / or axial longitudinal members. Two bending tests show that angular hinge members and / or axial longitudinal members formed of refractory metal alloys (such as MoRe) conform to the ideal bending shape by 23% and 31% respectively, compared to angular hinge members and / or axial longitudinal members formed of CoCr. The ability to conform to a specific shape depends largely on the recoil of the alloy used for the angular hinge members and / or axial longitudinal members. It has been found that angular articulated members and / or axial longitudinal members formed of refractory metal alloys or metal alloys containing at least 15 atomic weight % rhenium exhibit approximately 15-45% better fit (and all values ​​and ranges therebetween) to bend into an ideal curved shape formed by a die compared to angular articulated members and / or axial longitudinal members of the same size formed of Co-Cr alloys, TiAlV alloys, or Ni-Ti alloys. This improved shape fit results in improved fit of the expanded artificial heart valve frame to the shape of the treatment area, such as… Figure 11 A and Figure 11 As shown in B.

[0196] Figure 11 A demonstrates the fit of an expanded frame 500 formed of a Co-Cr alloy within an irregularly shaped annulus 400 of the heart, wherein the treatment area comprises calcium deposits (CD) and a leakage area (PVL) surrounding the periphery of the expanded frame. The expanded frame forms an EOA of approximately 585 mm². Due to the inability of the Co-Cr alloy to readily fit the irregular shape within the annulus, an open area of ​​approximately 46 mm² is located around the periphery of the expanded frame to allow for the PVL around the expanded TAV. Figure 11 B demonstrates the fit of an expanded frame 600, formed from a refractory metal alloy such as MoRe, into an irregularly shaped annulus 400 of the heart. Due to the improved fit of the refractory metal alloy to the irregular shape within the annulus, the expanded frame forms an EOA of approximately 679 mm². Therefore, only an area of ​​approximately 14 mm² is located around the periphery of the expanded frame. Compared to a Co-Cr alloy frame of the same shape and size, the expanded frame formed from the refractory metal alloy is shown to fit the irregularly shaped annulus 400 of the heart by more than 30% (e.g., 30-40% and all values ​​and ranges therebetween). Typically, compared to frames of the same size and construction formed from Co-Cr, TiAlV, or Ni-Ti alloys, expandable frames formed from refractory metal alloys or metal alloys containing at least 15 atomic-weight percent rhenium fit irregularly shaped body channels by approximately 10-50% (and all values ​​and ranges therebetween).

[0197] Figure 12 A to Figure 12 C shows graphs illustrating the stress versus area reduction percentage for angularly articulated members and / or axially longitudinal members formed from TiAlV, CoCr, and MoRe alloys. These graphs demonstrate the improved properties of angularly articulated members and / or axially longitudinal members in frames formed from refractory metal alloys (such as MoRe) compared to angularly articulated members and / or axially longitudinal members of the same size and construction formed from CoCr or TiAlV alloys, including improved properties such as strength, yield strength, ultimate tensile strength, fatigue ductility, greater deformation range, material integrity between plastic deformation and failure, and durability. Refractory metal alloys or metal alloys containing at least 15 atomic weight percent rhenium can have 1.5 to 5 times (and all values ​​and ranges therein) the strength of Co-Cr, TiAlV, or Ni-Ti alloys.

[0198] like Figure 13 As shown, angular hinged members and / or axial longitudinal members of the same size and construction formed from Co-Cr alloys, TiAlV alloys, or Ni-Ti alloys have greater stiffness and yield strength than angular hinged members and / or axial longitudinal members of the same size and construction.

[0199] Figures 14A to 14CThis is a graph showing the yield strength, ultimate strength, and fatigue ductility of angularly hinged members and / or axially longitudinal members formed from TiAlV, CoCr, and MoRe alloys after cold working to reduce the cross-sectional area of ​​these alloys. After cold working, refractory metal alloys (such as MoRe alloys) exhibit higher fatigue ductility, yield strength, and ultimate strength than Co-Cr and TiAlV alloys. Furthermore, cold working of MoRe alloys leads to an increase in ductility, while the ductility of CoCr and TiAlV alloys decreases with further cold working.

[0200] Figure 15 This study demonstrates the hydrophilicity of refractory metal alloys (such as MoRe alloys) compared to Co-Cr alloys or TiAlV alloys. The hydrophilicity of materials implanted in patients is an important property for cell adhesion, migration, and proliferation in the tissues on which the material is implanted. Figure 15 As shown, 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 Co-Cr alloys. 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 Ti alloys. Refractory metal alloys (such as MoRe alloys) have greater hydrophilicity than Co-Cr alloys and TiAlV alloys. When water droplets are positioned on the surface of MoRe alloys, MoRe alloys have a contact angle of 37° ± 3°. Refractory metal alloys or metal alloys containing at least 15 atomic weight% rhenium are generally hydrophilic, with contact angles of water droplets on the surface of refractory metal alloys ranging from 25° to 45° (and all values ​​and ranges therebetween), and typically from 30° to 42°.

[0201] Compared to expansion frames of artificial heart valves of the same size and construction formed from Co-Cr alloys, TiAlV alloys, or Ni-Ti alloys, expansion frames of artificial heart valves formed at least partially from refractory metal alloys or metal alloys containing at least 15 atomic weight percent rhenium result in reduced recoil, improved flexural fit, and greater radial strength, leading to the following non-limiting advantages: 1) Forming frames for artificial heart valves with thinner angular articulated members, axial longitudinal members, and / or strut joints, which results in i) safer vascularization when inserting the artificial heart valve through the body channel and reaching the treatment area. 1) Improved access pathway, and / or ii) reduced risk of bleeding and / or damage to the body access pathway and / or treatment area when the artificial heart valve is delivered to and / or expands in the treatment area; 2) Easier delivery of the artificial heart valve to the treatment area, which can result in: i) reduced trauma to the body access pathway (e.g., vascular, aortic arch trauma, etc.) during insertion and / or expansion of the artificial heart valve at the treatment area, and / or ii) a reduced risk of neurological complications (stroke); 3) Less recoil, which results in i) reduced curl profile size, ii) increased expansion at the treatment area after expansion in the treatment area. iii) Improved fit of the artificial heart valve; iv) Increased radial strength of the artificial heart valve frame after expansion of the treatment area; v) Requires only a single coiling cycle to coil the artificial heart valve onto a balloon catheter or other type of delivery device; v) Reduced incidence of damage to artificial heart valve components during coiling, expansion, and operation of the medical device (e.g., angular articulated members, axial longitudinal members, strut joints, and / or other components such as expandable frames, leaflets, skirts, coatings, etc.); vi) Larger effective orifice area (EOA) of the artificial heart valve after expansion of the medical device; vi) Increased fit of the artificial heart valve within the treatment area. The artificial heart valve is dilated to reduce pulmonary regurgitation (PVR), and / or vii) requires only a single dilation cycle of the balloon in the balloon catheter or other dilation mechanism to fully dilate the artificial heart valve; and / or 4) manufactures artificial heart valves with excellent material biology properties to: I) improve tissue adhesion and / or growth on or around the artificial heart valve; II) reduce adverse tissue reactions to the artificial heart valve; III) reduce the toxicity of the artificial heart valve; IV) potentially reduce intravalvular thrombosis during the lifespan of the artificial heart valve; and / or V) reduce the incidence of infection during the lifespan of the artificial heart valve.

[0202] Therefore, it will be found that the purposes set forth above and those that become clear from the foregoing description are effectively achieved, and since certain changes can be made to the described construction without departing from the spirit and scope of this disclosure, it is intended that all subject matter contained in the foregoing description and shown in the accompanying drawings should be interpreted as illustrative and not restrictive. This disclosure has been described with reference to preferred and alternative embodiments. Modifications and variations will become apparent to those skilled in the art upon reading and understanding the detailed discussion of this disclosure provided herein. This disclosure is intended to include all such modifications and variations, provided they fall within the scope of this disclosure. It should also be understood that the following claims are intended to cover all general and specific features of this disclosure described herein, as well as all statements of scope of this disclosure, which may fall within the scope according to the language.

[0203] In order to assist the Patent Office and any reader of this application and any resulting patent in interpreting the appended claims, the applicant does not intend for any appended claim or claim element to invoke 35 USC 112(f) unless the words “means for…” or “steps for…” are expressly used in a particular claim.

Claims

1. An expandable artificial heart valve comprising an expandable metallic frame and at least one leaflet connected to the expandable metallic frame; the expandable metallic frame being configured to be coiled in an opening in a body passage and further expand from a coiled orientation to an expandable orientation; the expandable metallic frame having a distal end and a proximal end; the expandable metallic frame comprising a) an open mesh construction comprising a plurality of frame meshes and at least two rows of frame meshes, and / or b) being formed of a material having less than 10% recoil, thereby resulting in reduced recoil of the expandable metallic frame when expanding from the coiled orientation to the expandable orientation; the expandable metallic frame having two or more of the following characteristics: i) at least 70% to 100% of the expandable metallic frame is formed of a metallic alloy having a yield strength of at least 110 ksi, ii) at least 70% to 100% of the expandable metallic frame is formed of a metallic alloy having a yield strength of at least 35000 ksi. iii) A frame geometry having up to nine frame grids 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 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% to 100% of the expandable metal frame is 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 wherein the metal alloy is partially or completely formed from sintered metal powder; vi) When the expandable metal frame plastically deforms... When the shape is such that the expandable metal frame has a perspective shortening of no more than 20%, vii) each grid in the grid includes at least one axial longitudinal member and at least two angular hinge members, and each of the angular hinge members includes a plurality of arcuate portions along the longitudinal length of the angular hinge member, viii) each grid in the grid includes at least one axial longitudinal member and at least two angular hinge members, and each of the angular hinge members includes a plurality of arcuate portions along the longitudinal length of the angular hinge member, and 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 includes a reinforcing coating.

2. The expandable artificial heart valve of claim 1, wherein one or more of the frame meshes comprise at least two axial longitudinal members and at least two angular hinge members; each of the angular hinge members comprises a first arm and a second arm connected to a hinge joint; the hinge joint has an arcuate or semicircular portion; and each of the axial longitudinal members has a continuous linear shape of at least 90% of the longitudinal length of the axial longitudinal member.

3. The expandable artificial heart valve of claim 1, wherein at least one axial longitudinal member in the row frame grid is aligned along the same longitudinal axis to form an aligned set of axial longitudinal members, and the aligned set of axial longitudinal members extends fully from the distal end of the expandable metal frame to the proximal end; and wherein during expansion and / or curling of the expandable metal frame, the total longitudinal length of each frame grid in the row frame grid does not exceed the longitudinal length of each axial longitudinal member in the axial longitudinal member of the frame grid.

4. The expandable artificial heart valve of claim 2, wherein at least one axial longitudinal member in the row frame grid is aligned along the same longitudinal axis to form an aligned set of axial longitudinal members, and the aligned set of axial longitudinal members extends fully from the distal end of the expandable metal frame to the proximal end; and wherein during expansion and / or curling of the expandable metal frame, the total longitudinal length of each frame grid in the row frame grid does not exceed the longitudinal length of each axial longitudinal member in the axial longitudinal member of the frame grid.

5. The expandable artificial heart valve of claim 1, wherein one or more of the angular articulated members comprise one or more independent radii across its longitudinal length.

6. The expandable artificial heart valve according to any one of claims 2 to 4, wherein one or more of the angular articulated members comprise one or more independent radii across its longitudinal length.

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

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

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

11. The expandable artificial heart valve of claim 1, wherein the longitudinal length between the proximal end of the expandable frame and the fusion attachment region on the expandable frame is constant during the expansion and / or curling of the expandable frame.

12. The 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 commissural attachment region on the expandable frame is constant during the expansion and / or curling of the expandable frame.

13. The expandable artificial heart valve of claim 1, further comprising a fusion alignment mark positioned in the expandable frame; the fusion alignment mark being formed of the same material as the material used to form the expandable frame.

14. The expandable artificial heart valve according to any one of claims 2 to 12, further comprising a fusion alignment mark positioned in the expandable frame; the fusion alignment mark being formed of the same material as the material used to form the expandable frame.

15. The expandable artificial heart valve of claim 13, wherein the material used to form the synaptic alignment mark has a concentration greater than 10 mg / cm². 3 Metals with a certain density.

16. The expandable artificial heart valve of claim 14, wherein the material used to form the synaptic alignment mark has a concentration greater than 10 mg / cm². 3 Metals with a certain density.

17. The expandable artificial heart valve of claim 13, wherein the commissure alignment mark is attached to the commissure attachment region.

18. The expandable artificial heart valve according to any one of claims 14 to 16, wherein the commissure alignment mark is attached to the commissure attachment region.

19. The expandable artificial heart valve of claim 1, wherein the distal row of frame grids on the expandable frame comprises an odd number of frame grids.

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

21. The expandable artificial heart valve of claim 19, wherein the distal row of frame grids on the expandable frame comprises nine frame grids.

22. The expandable artificial heart valve of claim 20, wherein the distal row of frame grids on the expandable frame comprises nine frame grids.

23. The expandable artificial heart valve of claim 1, wherein the angular hinge members in the same column and / or row of the frame grid have the same longitudinal length.

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

25. The expandable artificial heart valve of claim 23, wherein all the angular hinge members in the frame grid have the same longitudinal length.

26. The expandable artificial heart valve of claim 24, wherein all the angular hinge members in the frame grid have the same longitudinal length.

27. The expandable artificial heart valve of claim 1, wherein the vertices of adjacently positioned frame grids in adjacent rows are aligned within 5% of the total longitudinal length of the angular hinge member.

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

29. The expandable artificial heart valve of claim 1, wherein the area of ​​each frame grid in the farthest row of frame grids on the expandable frame differs from the area of ​​each frame grid in the nearest side frame grid by no more than 20%.

30. The expandable artificial heart valve according to any one of claims 2 to 28, wherein the area of ​​each frame grid in the farthest row of frame grids on the expandable frame differs from the area of ​​each frame grid in the nearest side frame grid by no more than 20%.

31. The expandable artificial heart valve of claim 1, wherein the material of the expandable frame is at least partially made of a metal alloy comprising less than 1% by weight nickel and / or less than 0.1% by weight 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 of a metal alloy comprising 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; the expandable metal frame being configured to expand from a coiled orientation to an expanded orientation when the artificial heart valve is positioned at a treatment site in the heart; the expandable metal frame comprising a plurality of angular hinge members and a plurality of axial longitudinal members; the angular hinge members and the axial longitudinal members being joined together to form a plurality of tissue-lined grids in the expandable metal frame; each grid comprising at least one of the axial longitudinal members and at least two angular hinge members; each angular hinge member comprising a plurality of arcuate portions along the longitudinal length of the angular hinge member; one or more of the axial longitudinal members having a continuous linear shape of at least 80% of the longitudinal length of the axial longitudinal member; the expandable metal frame having a transparency shortening of no more than 20% when the expandable metal frame undergoes plastic deformation.

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

35. The artificial heart valve of claim 33, wherein the expandable metal frame comprises a first strut row, a second strut row, and a third strut row; each of the first strut row, the second strut row, and the third strut row comprises a plurality of angular hinge members; each of the angular hinge members in the first strut row comprises a first end and a second end, and wherein the first end of each angular hinge member is connected to one of the axial longitudinal members, and the second end of each angular hinge member is connected to a different axial longitudinal member; each angular hinge member in the second strut row comprises a first end and a second end, and wherein multiple or all of the first ends of the plurality or all of the angular hinge members are connected to one of the axial longitudinal members, and the angular hinge... Multiple or all of the second ends of the angular hinge members in the component are connected to different axial longitudinal members; each angular hinge member in the third column row includes a first end and a second end, and multiple or all of the first ends of the angular hinge members are connected to one of the axial longitudinal members, and multiple or all of the second ends of the angular hinge members are connected to different axial longitudinal members; when the expandable metal frame is in the expansion orientation, the angular hinge members in the first column row are spaced apart from the angular hinge members in the second and third column rows; when the expandable metal frame is in the expansion orientation, the angular hinge members in the second column row are spaced apart from the angular hinge members in the third column row.

36. The artificial heart valve of claim 34, wherein the expandable metal frame comprises a first strut row, a second strut row, and a third strut row; each of the first strut row, the second strut row, and the third strut row comprises a plurality of angular hinge members; each of the angular hinge members in the first strut row comprises a first end and a second end, and wherein the first end of each angular hinge member is connected to one of the axial longitudinal members, and the second end of each angular hinge member is connected to a different axial longitudinal member; each angular hinge member in the second strut row comprises a first end and a second end, and wherein multiple or all of the first ends of the plurality or all of the angular hinge members are connected to one of the axial longitudinal members, and the angular hinge... Multiple or all of the second ends of the angular hinge members in the component are connected to different axial longitudinal members; each angular hinge member in the third column row includes a first end and a second end, and multiple or all of the first ends of the angular hinge members are connected to one of the axial longitudinal members, and multiple or all of the second ends of the angular hinge members are connected to different axial longitudinal members; when the expandable metal frame is in the expansion orientation, the angular hinge members in the first column row are spaced apart from the angular hinge members in the second and third column rows; when the expandable metal frame is in the expansion orientation, the angular hinge members in the second column row are spaced apart from the angular hinge members in the third column row.

37. The artificial heart valve of claim 33, wherein the expandable metal frame includes a fourth strut row; the fourth strut row includes a plurality of angular hinge members; each of the angular hinge members in the first strut row includes a first end and a second end, and wherein one or all of the first ends of each angular hinge member are connected to one of the axial longitudinal members, and one or all of the second ends of each angular hinge member are connected to different axial longitudinal members; when the expandable metal frame is in the expansion orientation, the angular hinge members in the fourth strut row are all spaced apart from the angular hinge members in the first strut row, the second strut row, and the third strut row.

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 angular hinge members; each of the angular hinge members in the first strut row includes a first end and a second end, and wherein one or all of the first ends of each angular hinge member are connected to one of the axial longitudinal members, and one or all of the second ends of each angular hinge member are connected to different axial longitudinal members; when the expandable metal frame is in the expansion orientation, the angular hinge members in the fourth strut row are all spaced apart from the angular hinge members in the first strut row, the second strut row, and the third strut row.

39. The artificial heart valve of claim 33, wherein the plurality of axial longitudinal members include a first axial longitudinal member segment and a second axial longitudinal member segment; the first and second axial longitudinal member segments have 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 angular hinge members in the angular hinge members; the top end of the second end of each of the second axial longitudinal member segments is connected to the two angular hinge members in the angular hinge members and / or the bottom portion of one of the frame opening devices in the frame opening device.

40. The artificial heart valve according to any one of claims 34 to 38, wherein the plurality of axial longitudinal members include a first axial longitudinal member segment and a second axial longitudinal member segment; the first and second axial longitudinal member segments have 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 angular hinge members in the angular hinge members; the top end of the second end of each of the second axial longitudinal member segments is connected to the two angular hinge members in the angular hinge members and / or the bottom portion of one of the frame opening devices in the frame opening device.

41. The artificial heart valve of 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 is 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 is connected to a) the top end of the second axial longitudinal member segment and / or b) two angular hinge members in the angular hinge members; the top end of the third end of each of the second axial longitudinal member segments is connected to two angular hinge members in the angular hinge members.

42. The 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 is 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 is connected to a) the top end of the second axial longitudinal member segment and / or b) two angular hinge members in the angular hinge members; the top end of the third end of each of the second axial longitudinal member segments is connected to two angular hinge members in the angular hinge members.

43. The artificial heart valve of claim 33, wherein each of the angular hinge members comprises a centrally located arcuate portion and a first arm and a second arm extending from each side of the arcuate portion; the first arm of each of the angular hinge members has a first arm end; the second arm of each of the angular hinge members has a second arm end; each first arm end of the first arm end is connected to a) one of the axial longitudinal members and / or b) one of the frame opening devices; the longitudinal length of one or both of the first arm and the second arm of each of the angular hinge 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 angular hinge members comprises a centrally located arcuate portion and a first arm and a second arm extending from each side of the arcuate portion; the first arm of each of the angular hinge members has a first arm end; the second arm of each of the angular hinge members has a second arm end; each first arm end of the first arm end is connected to a) one of the axial longitudinal members and / or b) one of the frame opening devices; the longitudinal length of one or both of the first arm and the second arm of each of the angular hinge members is greater than the width or longitudinal length of the semicircular portion.

45. The artificial heart valve of claim 33, wherein each of the first arm and the second arm comprises one to three undulating portions.

46. ​​The artificial heart valve according to any one of claims 34 to 44, wherein each of the first arm and the second arm comprises one to three undulating portions.

47. The artificial heart valve of claim 33, wherein the expandable metal frame is formed partly or entirely of a refractory metal alloy or a metal alloy containing at least 15 atomic weight % 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 formed partly or entirely of a refractory metal alloy or a metal alloy containing at least 15 atomic weight% rhenium, and the refractory metal alloy or a metal alloy containing at least 5 atomic weight% rhenium, and the metal alloy is not a shape memory alloy.

49. The artificial heart valve of claim 33, wherein the expandable metal frame has: a) being formed of a material having reduced recoil when bent, such that when the expandable metal frame is rolled into a rolled state, the expandable frame has no more than 5% recoil; b) being formed of a material having reduced recoil when bent, such that when the expandable metal frame expands from a rolled state to an expanded state, the expandable frame has no more than 5% recoil; and / or c) a fluoroscopic shortening percentage of less than 20% when the expandable metal frame expands from the rolled state.

50. The artificial heart valve according to any one of claims 34 to 48, wherein the expandable metal frame has: a) being formed of a material having reduced recoil when bent, such that when the expandable metal frame is rolled into a rolled state, the expandable frame has no more than 5% recoil; b) being formed of a material having reduced recoil when bent, such that when the expandable metal frame expands from a rolled state to an expanded state, the expandable frame has no more than 5% recoil; and / or c) a fluoroscopic shortening percentage of less than 20% when the expandable metal frame expands from the rolled state.

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

52. The 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 of claim 51, wherein the leaflet structure comprises a plurality of leaflets, each leaflet having an upper edge portion, a lower edge portion and two side flaps, wherein each side flap is 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 of claim 52, wherein the leaflet structure comprises a plurality of leaflets, each leaflet having an upper edge portion, a lower edge portion and two side flaps, wherein each side flap is 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 of claim 33, further comprising an outer skirt; the outer skirt being positioned completely around a portion of the exterior of the expandable metal frame; 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; said outer skirt being positioned completely around a portion of the exterior of the expandable metal frame; said outer skirt being connected to the expandable metal frame.

57. The artificial heart valve of claim 33, wherein the expandable metal frame is partially or entirely 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 wherein the metal alloy is partially or entirely formed of metal powder sintered together.

58. The artificial heart valve according to any one of claims 34 to 56, wherein the expandable metal frame is partially or entirely 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 wherein the metal alloy is partially or entirely formed of metal powder sintered together.

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