Medical Devices Containing Rhenium-Chromium Alloys

Abstract

A rhenium-chromium metal alloy or a rhenium alloy that can be used to at least partially form a medical device.

Description

[Technical field]

[0001] This disclosure claims priority to U.S. Provisional Application No. 63 / 316,077, filed March 3, 2022, which is incorporated herein.

[0002] The present disclosure relates generally to rhenium metal alloys, more particularly to rhenium-chromium metal alloys, and even more particularly to rhenium-chromium metal alloys that at least partially form medical devices. [Background technology]

[0003] Stainless steels, cobalt chromium alloys, and TiAlV alloys are some of the more common metal alloys used in medical devices. Although these alloys have been successful in forming a variety of medical devices, these alloys suffer from several deficiencies.

[0004] Many cardiovascular devices, such as stents, expandable heart valves, etc., are inserted into a patient through the patient's vascular system and then expanded at the treatment site. These devices are typically crimped onto a catheter before being inserted into the patient. The minimum diameter that a cardiovascular device can be crimped onto a catheter sets a limit to the size of the cardiovascular passageway (e.g., blood vessel) into which the cardiovascular device can be inserted. A smaller crimped diameter can reduce damage to blood vessels and / or organs (e.g., heart, etc.) when inserting and / or placing the cardiovascular device at the treatment site. A smaller crimped diameter can also allow the cardiovascular device to be placed into smaller diameter blood vessels (e.g., blood vessels located in the brain, etc.).

[0005] The crimped diameter of an expandable cardiovascular device can be reduced by reducing the thickness and / or size of the frame, struts, etc. of the cardiovascular device. However, such a reduction in size also affects the strength of the cardiovascular device after expansion. After the cardiovascular device expands, it must retain its expanded shape in the treatment area or it may become dislodged from the treatment area, damage the treatment area, and / or not function properly in the treatment area. Thus, cardiovascular devices formed from conventional materials such as stainless steels (e.g., 316L: 17-19 wt. % chromium, 13-15 wt. % nickel, 2-4 wt. % molybdenum, max. 2 wt. % manganese, 0.75 wt. % max. silicon, max. 0.03 wt. % carbon, balance iron), and cobalt-chromium alloys (e.g., MP35N: 19-21 wt. % chromium, 34-36 wt. % nickel, 9-11 wt. % molybdenum, max. 1 wt. % iron, max. 1 wt. % titanium, max. 0.15 wt. % manganese, max. 0.15 wt. % silver, max. 0.025 wt. % carbon, balance cobalt) are required to maintain the size / thickness of the frame and / or struts, which limits the small extent of the crimped diameter that can be obtained by the crimped cardiovascular device. Other types of cobalt-chromium alloys in use are Phynox and Elgiloy alloys (38-42% by weight cobalt, 18-22% by weight chromium, 14-18% by weight iron, 13-17% by weight nickel, 6-8% by weight molybdenum), and L605 alloy (18-22% by weight chromium, 14-16% by weight tungsten, 9-11% by weight nickel, balance cobalt).

[0006] Also, conventional materials such as stainless steel (316L) and cobalt-chromium alloys (e.g., MP35N, etc.) have some recoil after crimping and expansion that may prevent obtaining a minimum crimped diameter and / or may adversely affect the placement of the expandable cardiovascular device at the treatment area. During the crimping process, a crimping device is typically used to crimp the cardiovascular device onto the catheter. After the initial crimping process, conventional materials such as stainless steel and cobalt-chromium alloys recoil to a diameter 9+% larger than the minimum crimped diameter. Thus, the cardiovascular device must be crimped onto the catheter multiple times to attempt to obtain a smaller crimped diameter on the catheter. However, subjecting the cardiovascular device to multiple crimps may result in damage to the cardiovascular device (e.g., damage to the frame and / or struts of the cardiovascular device, damage to the leaflets of the expandable heart valve, etc.). Similarly, conventional materials of cardiovascular devices recoil 9+% of the maximum expanded diameter when the cardiovascular device is expanded at the treatment area. Thus, the inflatable balloon on the catheter must be pressurized multiple times to repeatedly expand the cardiovascular device at the treatment area to ensure proper expansion of the cardiovascular device. However, subjecting the cardiovascular device to multiple balloon expansions may result in damage to the cardiovascular device (e.g., damage or breakage of the frame and / or struts, etc.) and / or damage to the treatment area (e.g., rupture of a blood vessel, rupture and / or puncture of tissue of an organ, etc.).

[0007] When a medical device is inserted into a patient, it is typically desirable to resist ionization and / or corrosion while the medical device is in the patient so as not to expose the patient to metal ions and / or oxides from the metals used to form the medical device while in the patient. Excessive ion release from the medical device can be potentially harmful to the patient. Conventional materials such as stainless steel (316L) and cobalt-chromium alloys (e.g., MP35N, etc.) are very stable when inserted into a patient, but some metal ion release occurs while the medical device is in the patient.

[0008] In view of the current state of medical devices, there is a need for improved medical devices that a) produce less recoil as compared to medical devices formed from stainless steel, cobalt-chromium alloys, or TiAlV alloys, b) are capable of forming smaller crimp diameters as compared to medical devices formed from stainless steel, cobalt-chromium alloys, or TiAlV alloys, and / or c) have reduced metal ion release as compared to medical devices formed from stainless steel, cobalt-chromium alloys, or TiAlV alloys. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0009] The present disclosure is directed to rhenium-chromium metal alloys and medical devices made at least in part from rhenium-chromium metal alloys or rhenium alloys. Medical devices formed at least in part from rhenium-chromium metal alloys or rhenium alloys include orthopedic devices, PFO (patent foramen ovale) devices, stents, valves (e.g., heart valves, TAVR valves, mitral valve replacements, tricuspid valve replacements, pulmonary valve replacements, etc.), spinal implants, frames and other structures used with spinal implants, vascular implants, grafts, guidewires, sheaths, catheters, needles, stent catheters, electrophysiology catheters, hypotubes, staples, cutting devices, implants of any type, pacemakers, dental implants, dental crowns, dental braces, wires used in medical procedures, bone implants, artificial discs, artificial spinal discs, bones (e.g., acromion, first cervical vertebra, axis, calcaneus, carpus, clavicle, prosthetic implants or devices for repairing, replacing, and / or supporting bones (such as coccyx, epicondyle, medial epicondyle, femur, fibula, frontal bone, greater trochanter, humerus, ilium, ischium, mandible, maxilla, metacarpals, metatarsals, occipital bone, olecranon, parietal bone, patella, phalanges, radius, ribs, sacrum, scapula, sternum, talus, thigh, temporal bone, tibia, ulna, zygoma, etc.) and / or cartilage, bone plates nails, rods, screws, posts, cages, plates, pedicle screws, caps, hinges, joint systems, anchors, spacers, shafts, anchors, discs, balls, tension bands, locking connectors and other structural assemblies used within the body to support, attach structures, and / or repair structures within the body, such as, but not limited to, a human body, an animal body, etc. In one non-limiting embodiment, the medical device comprises an expandable frame (e.g., a stent, a prosthetic heart valve, etc.) that can be plastically deformed radially outwardly by an expanded configuration (e.g., an inflatable balloon, etc.) In another non-limiting embodiment, the rhenium-chromium metal alloy or rhenium alloy is not a self-expanding alloy.

[0010] According to another and / or alternative non-limiting aspect of the present disclosure, a medical device is provided that is partially or completely formed from a rhenium-chromium metal alloy or a rhenium alloy. In one non-limiting embodiment, 5-100% (and all values ​​and ranges therebetween) of the medical device is formed from a rhenium-chromium metal alloy or a rhenium alloy.

[0011] According to another and / or alternative non-limiting aspect of the present disclosure, at least 50 weight percent of the rhenium-chromium metal alloy or rhenium alloy comprises rhenium (e.g., 50-75 weight percent, and all values ​​and ranges therebetween). In another non-limiting embodiment, at least 55 weight percent of the rhenium-chromium metal alloy or rhenium alloy comprises rhenium. In another non-limiting embodiment, at least 60 weight percent of the rhenium-chromium metal alloy or rhenium alloy comprises rhenium.

[0012] According to another and / or alternative non-limiting aspect of the present disclosure, at least 25 weight percent of the rhenium-chromium metal alloy or rhenium alloy comprises chromium (e.g., 25-49.9 weight percent, and all values ​​and ranges therebetween). In another non-limiting embodiment, at least 30 weight percent of the rhenium-chromium metal alloy or rhenium alloy comprises chromium. In another non-limiting embodiment, at least 33 weight percent of the rhenium-chromium metal alloy or rhenium alloy comprises chromium.

[0013] According to another and / or alternative non-limiting aspect of the present disclosure, at least 50 weight percent of the rhenium-chromium metal alloy or rhenium alloy (e.g., 50-74.9 weight percent, and all values ​​and ranges therebetween) comprises rhenium, at least 25 weight percent of the rhenium-chromium metal alloy or rhenium alloy (e.g., 25-49.9 weight percent, and all values ​​and ranges therebetween) comprises chromium, and 0.1-25 weight percent of the rhenium-chromium-chromium metal alloy or rhenium alloy (and all values ​​and ranges therebetween) comprises one or more of aluminum, bismuth, cobalt, copper, hafnium, iridium, iron, magnesium, manganese, molybdenum, nickel, niobium, osmium, rhodium, ruthenium, silicon, silver, tantalum, technetium, titanium, tungsten, vanadium, yttrium, and / or zirconium.

[0014] According to another and / or alternative non-limiting aspect of the present disclosure, at least 55 weight percent of the rhenium-chromium metal alloy or rhenium alloy comprises rhenium, at least 30 weight percent of the rhenium-chromium metal alloy or rhenium alloy comprises chromium, and at least 0.1 to 15 weight percent of the rhenium-chromium metal alloy or rhenium alloy comprises one or more of aluminum, bismuth, cobalt, copper, hafnium, iridium, iron, magnesium, manganese, molybdenum, nickel, niobium, osmium, rhodium, ruthenium, silicon, silver, tantalum, technetium, titanium, tungsten, vanadium, yttrium, and / or zirconium.

[0015] According to another and / or alternative non-limiting aspect of the present disclosure, at least 60 weight percent of the rhenium-chromium metal alloy or rhenium alloy (e.g., 60-69.9 weight percent, and all values ​​and ranges therebetween) comprises rhenium, at least 30 weight percent of the rhenium-chromium metal alloy or rhenium alloy (e.g., 30-39.9 weight percent, and all values ​​and ranges therebetween) comprises chromium, and 0.1-10 weight percent of the rhenium-chromium-chromium metal alloy or rhenium alloy (and all values ​​and ranges therebetween) comprises one or more of aluminum, bismuth, cobalt, copper, hafnium, iridium, iron, magnesium, manganese, molybdenum, nickel, niobium, osmium, rhodium, ruthenium, silicon, silver, tantalum, technetium, titanium, tungsten, vanadium, yttrium, and / or zirconium.

[0016] According to another and / or alternative non-limiting aspect of the present disclosure, at least 62 weight percent of the rhenium-chromium metal alloy or rhenium alloy (e.g., 62 to 67.9 weight percent, and all values ​​and ranges therebetween) comprises rhenium, at least 32 weight percent of the rhenium-chromium metal alloy or rhenium alloy (e.g., 32 to 32.9 weight percent, and all values ​​and ranges therebetween) comprises chromium, and 0.1 to 6 weight percent of the rhenium-chromium-chromium metal alloy or rhenium alloy (and all values ​​and ranges therebetween) comprises one or more of aluminum, bismuth, cobalt, copper, hafnium, iridium, iron, magnesium, manganese, molybdenum, nickel, niobium, osmium, rhodium, ruthenium, silicon, silver, tantalum, technetium, titanium, tungsten, vanadium, yttrium, and / or zirconium.

[0017] According to another and / or alternative non-limiting aspect of the present disclosure, the weight percentage of rhenium in the rhenium-chromium metal alloy or rhenium alloy is less than 50 weight percent; the rhenium-chromium metal alloy or rhenium alloy comprises 0.1 to 50 weight percent of an alloying agent, the alloying agent comprising one or more metals selected from the group consisting of aluminum, bismuth, cobalt, copper, hafnium, iridium, iron, magnesium, manganese, molybdenum, nickel, niobium, osmium, rhodium, ruthenium, silicon, silver, tantalum, technetium, titanium, tungsten, vanaum, yttrium, and / or zirconium; the weight percentage of chromium in the rhenium-chromium metal alloy or rhenium alloy is at least 25 weight percent; and the combined weight percentage of rhenium and chromium is at least 35 weight percent of the rhenium-chromium metal alloy or rhenium alloy (e.g., 35 to 99.9 weight percent, and all values ​​and ranges therebetween).

[0018] According to another and / or alternative non-limiting aspect of the present disclosure, the weight percentage of rhenium in the rhenium-chromium metal alloy or rhenium alloy is less than 50 weight percent; the rhenium-chromium metal alloy or rhenium alloy comprises 0.1-30 weight percent of an alloying agent, the alloying agent comprising one or more metals selected from the group consisting of aluminum, bismuth, cobalt, copper, hafnium, iridium, iron, magnesium, manganese, molybdenum, nickel, niobium, osmium, rhodium, ruthenium, silicon, silver, tantalum, technetium, titanium, tungsten, vanaum, yttrium, and / or zirconium; the weight percentage of chromium in the rhenium-chromium metal alloy or rhenium alloy is at least 25 weight percent; and the combined weight percentage of rhenium and chromium is at least 70 weight percent of the rhenium-chromium metal alloy or rhenium alloy (e.g., 70-99.9 weight percent, and all values ​​and ranges therebetween).

[0019] According to another and / or alternative non-limiting aspect of the present disclosure, the weight percentage of rhenium in the rhenium-chromium metal alloy or rhenium alloy is less than 50 weight percent; the rhenium-chromium metal alloy or rhenium alloy comprises 0.1-25 weight percent of an alloying agent, the alloying agent comprising one or more metals selected from the group consisting of aluminum, bismuth, cobalt, copper, hafnium, iridium, iron, magnesium, manganese, molybdenum, nickel, niobium, osmium, rhodium, ruthenium, silicon, silver, tantalum, technetium, titanium, tungsten, vanadium, yttrium, and / or zirconium; the weight percentage of chromium in the rhenium-chromium metal alloy or rhenium alloy is at least 25 weight percent; and the combined weight percentage of rhenium and chromium is at least 75 weight percent of the rhenium-chromium metal alloy or rhenium alloy (e.g., 75-99.9 weight percent, and all values ​​and ranges therebetween).

[0020] According to another and / or alternative non-limiting aspect of the present disclosure, the rhenium-based alloy contains 10-60 atomic weight percent (atw.%) Re (and all values ​​and ranges therebetween) and contains one or more metals selected from the group consisting of Mo, Cr, Ta, Nb, Ti, and Zr. In one non-limiting embodiment, the Cr content in the rhenium-based alloy constitutes the first or second highest atomic weight percent component of the rhenium-based alloy. In another non-limiting embodiment, the Cr content in the rhenium-based alloy constitutes the first or second highest atomic weight percent component of the rhenium-based alloy, and the atomic weight percent of Cr in the rhenium-based alloy is greater than the atomic weight percent of Mo in the rhenium-based alloy.

[0021] According to another and / or alternative non-limiting aspect of the present disclosure, the rhenium-based alloy comprises 0.5-50 atw.% Re (and all values ​​and ranges therebetween) and 0.5-70 atw.% Cr (and all values ​​and ranges therebetween). In one non-limiting embodiment, the rhenium-based alloy comprises 5-50 atw.% Re and 5-70 atw.% Cr. In another non-limiting embodiment, the rhenium-based alloy comprises 5-50 atw.% Re and 5-70 atw.% Cr, and 0-49.9 awt.% (and all values ​​and ranges therebetween) of one or more of aluminum, bismuth, cobalt, copper, hafnium, iridium, iron, magnesium, manganese, molybdenum, nickel, niobium, osmium, rhodium, ruthenium, silicon, silver, tantalum, technetium, titanium, tungsten, vanadium, yttrium, and / or zirconium. In another non-limiting embodiment, the rhenium-based alloy includes 15-50 atw.% Re and 25-70 atw.% Cr, and 0-49.9 wt.% (and all values ​​and ranges therebetween) of one or more of aluminum, bismuth, cobalt, copper, hafnium, iridium, iron, magnesium, manganese, molybdenum, nickel, niobium, osmium, rhodium, ruthenium, silicon, silver, tantalum, technetium, titanium, tungsten, vanadium, yttrium, and / or zirconium. In another non-limiting embodiment, the rhenium-based alloy comprises 20-50 atw.% Re and 25-70 atw.% Cr, and 0-49.9 awt.% (and all values ​​and ranges therebetween) of one or more of aluminum, bismuth, cobalt, copper, hafnium, iridium, iron, magnesium, manganese, molybdenum, nickel, niobium, osmium, rhodium, ruthenium, silicon, silver, tantalum, technetium, titanium, tungsten, vanadium, yttrium, and / or zirconium. In another non-limiting embodiment, the atomic weight percentage of rhenium plus chromium in the rhenium-based alloy is at least 50 awt.% (e.g., 50-100 awt.%, and all values ​​and ranges therebetween).In another non-limiting embodiment, the atomic weight percentage of rhenium plus chromium in the rhenium-based alloy is at least 60 awt.% (e.g., 60-100 awt.%, and all values ​​and ranges therebetween). In another non-limiting embodiment, the atomic weight percentage of rhenium plus chromium in the rhenium-based alloy is at least 75 awt.% (e.g., 75-100 awt.%, and all values ​​and ranges therebetween).

[0022] In another non-limiting embodiment, the rhenium-chromium metal alloy or rhenium alloy contains 0-0.1 wt. % (and all values ​​and ranges therebetween) of impurities (e.g., metals other than aluminum, bismuth, cobalt, copper, hafnium, iridium, iron, magnesium, manganese, molybdenum, nickel, niobium, osmium, rhodium, ruthenium, silicon, silver, tantalum, technetium, titanium, tungsten, vanadium, yttrium, and zirconium).

[0023] Some non-limiting examples of rhenium-chromium metal alloys or rhenium alloys that can be made according to the present disclosure are given below: [Table 1] [Table 2] [Table 3] [Table 4] [Table 5] [Table 6]

[0024] In Examples 1-24, all of the ranges above will be understood to include any value between the range stated above and any other range between the ranges stated above. Any of the values ​​above including the < symbol includes the range from 0 to the stated value, and all values ​​and ranges therebetween.

[0025] According to another and / or alternative non-limiting embodiment of the present disclosure, the combined total weight percentage of rhenium and chromium in the rhenium-chromium metal alloys or rhenium alloys of Examples 1-24 is at least 60 weight percent (e.g., 60-100 weight percent, and all values ​​and ranges therebetween).

[0026] According to another and / or alternative non-limiting embodiment of the present disclosure, the combined total weight percentage of rhenium and chromium in the rhenium-chromium metal alloys or rhenium alloys of Examples 1-24 is at least 75 wt.%.

[0027] According to another and / or alternative non-limiting embodiment of the present disclosure, the combined total weight percentage of rhenium and chromium in the rhenium-chromium metal alloys or rhenium alloys of Examples 1-24 is at least 90 wt.%.

[0028] According to another and / or alternative non-limiting embodiment of the present disclosure, the combined total weight percentage of rhenium and chromium in the rhenium-chromium metal alloys or rhenium alloys of Examples 1-24 is at least 95 wt.%.

[0029] According to another and / or alternative non-limiting embodiment of the present disclosure, the combined total weight percentage of rhenium and chromium in the rhenium-chromium metal alloys or rhenium alloys of Examples 1-24 is at least 98 wt.%.

[0030] According to another and / or alternative non-limiting embodiment of the present disclosure, the combined total weight percentage of rhenium and chromium in the rhenium-chromium metal alloys or rhenium alloys of Examples 1-24 is at least 99 wt.%.

[0031] According to another and / or alternative non-limiting embodiment of the present disclosure, the combined total weight percentage of rhenium and chromium in the rhenium-chromium metal alloys or rhenium alloys of Examples 1-24 is at least 99.5 wt.%.

[0032] According to another and / or alternative non-limiting aspect of the present disclosure, a medical device (e.g., a stent, a prosthetic heart valve, etc.) is provided that is configured to be radially collapsible to a folded or crimped state for introduction into the body on a delivery catheter, and radially expandable to an expanded state for implanting the prosthetic heart valve at a desired location within the body (e.g., blood vessel, heart, ureter, bile duct, pancreatic duct, esophagus, lung, eye, sinus, oral stent, etc.). The frame of the medical device can be formed of a plastically expandable material that allows the frame to be crimped to a smaller profile for delivery and expansion of the medical device using an expansion device such as the balloon of a balloon catheter. According to one non-limiting embodiment, the frame of the medical device is formed of 20-100% by weight (and all values ​​and ranges therebetween) of the rhenium-chromium metal alloy or rhenium alloy described above.

[0033] According to another and / or alternative non-limiting aspect of the present disclosure, a medical device is provided that includes a frame including a plurality of angularly spaced columns, vertically extending columns, or struts. The columns can be interconnected via a lower row of circumferentially extending struts and an upper row of circumferentially extending struts. The struts can be configured in a variety of patterns (e.g., zigzag patterns, sawtooth patterns, triangular patterns, polygonal patterns, elliptical patterns, etc.). One or more of the columns and / or struts can have the same or different thicknesses and / or cross-sectional shapes and / or cross-sectional areas. According to one non-limiting embodiment, the frame of the medical device is formed of 20-100 weight percent (and all values ​​and ranges therebetween) of the rhenium-chromium metal alloy or rhenium alloy described above.

[0034] According to another and / or alternative non-limiting aspect of the present disclosure, a medical device is provided that includes a frame that can be optionally 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.). The coating can be used to partially or completely encapsulate struts on the frame and / or fill openings between the struts. According to one non-limiting embodiment, the frame of the medical device is formed of 20-100% by weight (and all values ​​and ranges therebetween) of the rhenium-chromium metal alloy or rhenium alloy described above.

[0035] According to another and / or alternative non-limiting aspect of the present disclosure, the above-mentioned rhenium-chromium metal alloy or rhenium alloy used to form at least a portion of a medical device has one or more improved properties (e.g., strength, durability, hardness, biostability, bendability, coefficient of friction, radial strength, flexibility, tensile strength, tensile elongation, longitudinal elongation, stress-strain properties, reduced recoil, radiopacity, thermal sensitivity, biocompatibility, improved fatigue life, crack resistance, crack propagation, reduced magnetic susceptibility, etc.), improved conformability when bent, reduced recoil, increased yield strength, improved fatigue ductility, improved durability, improved fatigue life, reduced adverse tissue reaction, reduced metal ion release, reduced corrosion, reduced allergic reaction, improved hydrophilicity, reduced toxicity, reduced thickness of the metal component, improved bone integration, and / or reduced ion release to tissue. These one or more improved physical properties of the rhenium-chromium metal alloy or rhenium alloy described above can be achieved in a medical device without increasing the bulk, volume, and / or weight of the medical device, and in some instances, these improved physical properties can be obtained even when the volume, volume, and / or weight of the medical device is reduced as compared to medical devices formed at least in part from conventional stainless steel, titanium alloy, or cobalt and chromium alloy materials.

[0036] In another and / or alternative non-limiting aspect of the present disclosure, the above-mentioned rhenium-chromium metal alloy or rhenium alloy used to at least partially form a medical device may thus: 1) increase the radiopacity of the medical device; 2) increase the radial strength of the medical device; 3) increase the yield strength and / or ultimate tensile strength of the medical device; 4) improve the stress strain characteristics of the medical device; 5) improve the crimping and / or expansion characteristics of the medical device; 6) improve the bendability and / or flexibility of the medical device; 7) improve the strength and / or durability of the medical device; 8) improve the hardness of the medical device; 9) improve the recoil characteristics of the medical device; 10) improve the biostability and / or biocompatibility characteristics of the medical device; 11) improve the fatigue resistance of the medical device; 12) resist cracking and resist crack propagation of the medical device; 13) allow smaller, thinner, and / or lighter medical devices to be made; 14)) reduce the outer diameter of the crimped medical device; 15) enhance the therapeutic potential of the medical device; 15) improve the conformance of the medical device to the shape of the treatment area when used and / or expanded within the area, 16) reduce the amount of recoil of the medical device to the shape of the treatment area when the medical device is expanded within the treatment area, 17) increase the yield strength of the medical device, 18) improve the durability of the medical device, 19) improve the fatigue life of the medical device, 20) reduce adverse tissue reactions following implantation of the medical device, 21) reduce metal ion release following implantation of the medical device, 22) reduce corrosion of the medical device following implantation of the medical device, 23) reduce allergic reactions following implantation of the medical device, 24) improve the hydrophilicity of the medical device, 25) reduce the thickness of the metal components of the medical device, 26) improve bone integration with the medical device, 27) reduce ion release from the medical device to tissue, 28) reduce magnetic susceptibility of the medical device when implanted in a patient, and / or 29) reduce toxicity of the medical device following implantation of the medical device.

[0037] In another and / or alternative non-limiting aspect of the present disclosure, the medical device comprising the above-mentioned rhenium-chromium metal alloy or rhenium alloy is optionally subjected to one or more manufacturing processes. These manufacturing processes may include, but are not limited to, expansion, laser cutting, etching, crimping, annealing, drawing, pilger rolling, electroplating, electropolishing, machining, plasma coating, 3D printing coating, chemical vapor deposition, chemical polishing, cleaning, pickling, ion beam deposition or implantation, sputter coating, vacuum deposition, hot isostatic pressing (HIP), sintering, extrusion, isostatic pressing, vacuum sintering, etc. In one non-limiting embodiment, at least a portion or all of the medical device is formed by a 3D printing process.

[0038] In another and / or alternative non-limiting aspect of the present disclosure, the above-mentioned rhenium-chromium metal alloy or rhenium alloy used to at least partially form the medical device optionally has a generally uniform density throughout the rhenium-chromium metal alloy or rhenium alloy and provides the desired yield and ultimate tensile strength of the rhenium-chromium metal alloy or rhenium alloy. The density of the rhenium-chromium metal alloy is generally at least about 5 gm / cc (e.g., 5 gm / cc-21 gm / cc, and all values ​​and ranges therebetween), typically about 8-20 gm / cc, typically at least about 9-19 gm / cc. This substantially uniform high density of the rhenium-chromium metal alloy or rhenium alloy can be used to improve the radiopacity of the rhenium-chromium metal alloy or rhenium alloy.

[0039] In another and / or alternative non-limiting aspect of the present disclosure, the above-mentioned rhenium-chromium metal alloy or rhenium alloy optionally contains a certain amount of carbon and oxygen, but this is not required. These two elements have been found to affect the forming characteristics and brittleness of the rhenium-chromium metal alloy or rhenium alloy. The controlled atomic ratio of carbon and oxygen in the rhenium-chromium metal alloy or rhenium alloy also minimizes the tendency of the rhenium-chromium metal alloy or rhenium alloy to form microcracks at least partially during the formation of the rhenium-chromium metal alloy or rhenium alloy into a medical device and / or during the use and / or expansion of the medical device in the body. The control of the atomic ratio of carbon to oxygen in the rhenium-chromium metal alloy or rhenium alloy allows for the redistribution of oxygen in the rhenium-chromium metal alloy or rhenium alloy to minimize the tendency of microcracks in the rhenium-chromium metal alloy or rhenium alloy at least partially during the formation of the rhenium-chromium metal alloy or rhenium alloy into a medical device and / or during the use and / or expansion of the medical device in the body. The atomic ratio of carbon to oxygen in the rhenium-chromium metal alloy or rhenium alloy is believed to facilitate minimizing the tendency of microcracks in the rhenium-chromium metal alloy or rhenium alloy and improve the degree of elongation of the rhenium-chromium metal alloy or rhenium alloy, both of which may affect one or more physical properties of the rhenium-chromium metal alloy or rhenium alloy that are useful or desired in the formation and / or use of a medical device. The atomic ratio of carbon to oxygen can be as low as about 0.2:1 (e.g., 0.2:1 to 50:1, and all values ​​and ranges therebetween). In one non-limiting formulation, the atomic ratio of carbon to oxygen in the rhenium-chromium metal alloy or rhenium alloy is generally at least about 0.3:1. Typically, the carbon content of the rhenium-chromium metal alloy is less than about 0.1% by weight (e.g., 0 to 0.0999999% by weight, and all values ​​and ranges therebetween), and more typically, 0 to 0.01% by weight. Too much carbon content can adversely affect the physical properties of the rhenium-chromium metal alloy or rhenium alloy. Generally, the oxygen content should be kept at a very low level.In one non-limiting formulation, the oxygen content is less than about 0.1% by weight of the rhenium-chromium metal alloy or rhenium alloy (e.g., 0-0.0999999% by weight and all values ​​and ranges therebetween), typically 0-0.01% by weight. It is believed that the rhenium-chromium metal alloy or rhenium alloy has a very low tendency to form microcracks during the formation of the medical device and after the medical device is inserted into the patient when the oxygen content exceeds a certain amount in the rhenium-chromium metal alloy or rhenium alloy by tightly controlling the carbon to oxygen ratio. In one non-limiting configuration, the carbon to oxygen atomic ratio in the rhenium-chromium metal alloy or rhenium alloy is at least about 2.5:1 when the oxygen content is greater than about 100 ppm in the rhenium-chromium metal alloy or rhenium alloy.

[0040] In another and / or alternative non-limiting aspect of the present disclosure, the above-mentioned rhenium-chromium metal alloy or rhenium alloy optionally contains a controlled amount of nitrogen, but this is not required. A large amount of nitrogen in the rhenium-chromium metal alloy or rhenium alloy can adversely affect the ductility of the rhenium-chromium metal alloy or rhenium alloy. This can adversely affect the elongation properties of the rhenium-chromium metal alloy or rhenium alloy. If the nitrogen content in the rhenium-chromium metal alloy or rhenium alloy is too high, the ductility of the rhenium-chromium metal alloy or rhenium alloy begins to decrease unacceptably, and thus can adversely affect one or more physical properties of the rhenium-chromium metal alloy or rhenium alloy that are useful or desirable for forming and / or using a medical device. In one non-limiting formulation, the rhenium-chromium metal alloy or rhenium alloy contains less than about 0.001% nitrogen by weight (e.g., 0% to 0.0009999% by weight, and all values ​​and ranges therebetween). It is believed that the nitrogen content must be less than the carbon or oxygen content in the rhenium-chromium metal alloy or rhenium 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 nitrogen to oxygen is at least about 1.2:1 (e.g., 1.2:1 to 150:1, and all values ​​and ranges therebetween).

[0041] In another and / or alternative non-limiting aspect of the present disclosure, the rhenium-chromium metal alloy or rhenium alloy described above used to form all or a portion of a medical device 1) is optionally not coated, metal sprayed, plated, and / or formed (e.g., cold worked, hot worked, etc.) onto another metal, or 2) is optionally free of another metal or metal alloy that has been metal sprayed, plated, coated, and / or formed onto the rhenium-chromium metal alloy or rhenium alloy.

[0042] In another and / or alternative non-limiting aspect of the present disclosure, the medical device may optionally be formed from a tube or rod of rhenium-chromium metal alloy or rhenium alloy or may be formed into a shape that is at least 80% of the final product shape of the medical device.

[0043] In another and / or alternative non-limiting aspect of the present disclosure, the rhenium-chromium metal alloys or rhenium alloys described above have several physical properties that positively impact a medical device when the medical device is at least partially formed from the rhenium-chromium metal alloys or rhenium alloys of the present disclosure. In one non-limiting embodiment of the present disclosure, the average Vickers hardness of the rhenium-chromium metal alloys or rhenium alloys of the present disclosure used to at least partially form the medical device is optionally at least about 150 Vickers (e.g., 150-300 Vickers, and all values ​​and ranges therebetween), typically 160-240 Vickers, although this is not required. The rhenium-chromium metal alloys or rhenium alloys of the present disclosure generally have an average hardness greater than that of stainless steel. In another and / or alternative non-limiting embodiment of the present disclosure, the average ultimate tensile strength of the rhenium-chromium metal alloy or rhenium alloy of the present disclosure is optionally, but not required to be, at least about 125 ksi (e.g., 125 to 300 ksi, and all values ​​and ranges therebetween). In yet another and / or alternative non-limiting embodiment of the present disclosure, the average yield strength of the rhenium-chromium metal alloy or rhenium alloy of the present disclosure is optionally, but not required to be, at least about 100 ksi (e.g., 100 to 275 ksi, and all values ​​and ranges therebetween). In yet another and / or alternative non-limiting embodiment of the present disclosure, the average grain size of the rhenium-chromium metal alloy or rhenium alloy of the present disclosure used to at least partially form the medical device is optionally about 4 ASTM or less (e.g., 4 ASTM to 20 ASTM using ASTM E112, and all values ​​and ranges therebetween, e.g., 0.35 microns to 90 microns, and all values ​​and ranges therebetween). The small particle size of the rhenium-chromium metal alloy or rhenium alloy of the present disclosure allows the medical device to have desirable elongation and ductility properties useful in allowing the medical device to be formed, crimped, and / or expanded.

[0044] In another and / or alternative non-limiting embodiment of the present disclosure, the average tensile elongation of the above-mentioned rhenium-chromium metal alloy or rhenium alloy used to at least partially form the medical device optionally has an average tensile strength of at least about 25% (e.g., 25-50% average tensile elongation, and all values ​​and ranges therebetween). An average tensile elongation of at least 25% of the rhenium-chromium metal alloy or rhenium alloy is useful to facilitate proper expansion of the medical device when positioned in the treatment area of ​​the body. Medical devices that do not have an average tensile elongation of at least about 25% may be more susceptible to the formation of microcracks and / or breakage during formation, crimping, and / or expansion of the medical device. The unique combination of metals in the disclosed rhenium-chromium metal alloy or rhenium alloy in combination with achieving the desired purity and composition of the alloy and the desired grain size of the rhenium-chromium metal alloy or rhenium alloy provides: 1) a medical device having a desired high ductility at about room temperature; 2) a medical device having a desired tensile elongation; 3) a homogenous or solid solution of the rhenium-chromium metal alloy or rhenium alloy having high radiopacity; 4) reduction or prevention of microcrack formation and / or fracture of the rhenium-chromium metal alloy or rhenium alloy of the disclosed tube when the tube is sized and / or cut to form the medical device; 5) reduction or prevention of microcrack formation and / or fracture of the medical device when the device is crimped. 5) a medical device that is capable of performing a desired action on the medical device, 6) reducing or preventing microcracking and / or fracture of the medical device when it is bent and / or expanded in the body, 7) a medical device that has a desired ultimate tensile strength and yield strength, 8) a medical device that has a very thin wall thickness and still has the desired radial force needed to hold the medical device open when expanded, 9) a medical device that exhibits less recoil when it is crimped onto a delivery system and / or expanded in the body, 10) a medical device that exhibits improved conformity to the shape of the treatment area in the body when it is expanded in the body, 11) a medical device that exhibits improved fatigue ductility, and / or 12) a medical device that exhibits improved durability.

[0045] In another and / or alternative non-limiting aspect of the present disclosure, the above-mentioned rhenium-chromium metal alloy or rhenium alloy is optionally at least partially formed by a swaging process, but this is not required. In one non-limiting embodiment, swaging is performed on the rhenium-chromium metal alloy or rhenium alloy to at least partially or completely achieve the final dimensions of one or more portions of the medical device. The swaging die can be shaped to match the final dimensions of the medical device, but this is not required. If the medical device has an undercut of the hollow structure (which is not required), a separate metal piece can be placed in the undercut to at least partially fill the gap. The separate metal piece (when used) can be designed to be later removed from the undercut, but this is not required. The swaging operation can be performed on the medical device in the area to be hardened. In the case of a round or curved portion of the medical device, the swaging can be rotary. In the case of a non-circular portion of the medical device, the swaging of the non-circular portion of the medical device can be performed by a non-rotating swaging die. The die can optionally be made to oscillate radially and / or longitudinally instead of or in addition to rotating. The medical device can optionally be swaged in multiple directions in a single operation or multiple operations to achieve hardness in desired locations and / or directions of the medical device. The swaging temperature for a particular rhenium-chromium metal alloy can vary. For a rhenium-chromium metal alloy or rhenium alloy, the swaging temperature can be from room temperature (RT) (e.g., 10-27°C, and all values ​​and ranges therebetween) to about 400°C (e.g., 10-400°C, and all values ​​and ranges therebetween) if the swaging is performed in air or an oxidizing environment. If the swaging process is performed in a controlled neutral or non-reducing environment (e.g., an inert environment), the swaging temperature can be increased up to about 1500°C (e.g., 10-1550°C, and all values ​​and ranges therebetween). The rhenium-chromium metal alloy or rhenium alloy may optionally be preheated before being subjected to the swaging process.In one non-limiting configuration, the rhenium-chromium metal alloy or rhenium alloy is preheated (e.g., 400-1550°C, and all values ​​and ranges therebetween; 5-45 minutes) for 1-200 minutes (and all values ​​and ranges therebetween; 1350-1450°C). Swaging can be performed by repeatedly hammering the medical device where it is hardened at the desired swaging temperature. The rhenium-chromium metal alloy or rhenium alloy can optionally be first annealed to soften it, and then the rhenium-chromium metal alloy or rhenium alloy can be machined into the desired shape. After the rhenium-chromium metal alloy or rhenium alloy is shaped, the rhenium-chromium metal alloy or rhenium alloy can be rehardened. Hardening the rhenium-chromium metal alloy or rhenium alloy can improve the wear resistance and / or shape retention of the metal alloy. Rhenium-chromium metal alloys or rhenium alloys for medical use generally cannot be rehardened by annealing, so a special rehardening process is required. Such rehardening can be accomplished by the swaging process of the present disclosure. In one non-limiting embodiment, during the swaging process, boron and / or nitrogen ions are optionally allowed to bombard rhenium atoms in the rhenium-chromium metal alloy or rhenium alloy to form ReB2, ReN2, and / or ReN3, but this is not required. ReB2, ReN2, and / or ReN3 have been found to be superhard compounds. In one non-limiting process, the metal for medical devices can be machined and formed into medical devices when the metal is in a less hardened state.

[0046] In another and / or alternative non-limiting aspect of the present disclosure, the above-mentioned rhenium-chromium metal alloy or rhenium alloy can be optionally nitrided. The nitrided layer on the rhenium-chromium metal alloy or rhenium alloy can optionally function as a lubricating surface during the optional drawing of the rhenium-chromium metal alloy or rhenium alloy when partially or completely forming the medical device. After the rhenium-chromium metal alloy or rhenium alloy is nitrided, the rhenium-chromium metal alloy or rhenium alloy is typically washed, but this is not required. During the nitriding process, the surface of the rhenium-chromium metal alloy or rhenium alloy is modified by the presence of nitrogen. The nitriding process can be mono by gas nitriding, salt bath nitriding, or plasma nitriding. The rhenium-chromium metal alloy or rhenium alloy can be optionally exposed to argon and / or hydrogen gas to clean and / or preheat the rhenium-chromium metal alloy or rhenium alloy before the nitriding process. These gases can be optionally used to clean the oxide layer and / or solvent from the surface of the rhenium-chromium metal alloy or rhenium alloy. During the nitriding process, the rhenium-chromium metal alloy or rhenium alloy can be optionally exposed to hydrogen gas to inhibit or prevent the formation of oxides on the surface of the rhenium-chromium metal alloy or rhenium alloy. The nitrided surface layer has a thickness of less than about 1 mm. In one non-limiting embodiment, the nitrided surface layer has a thickness of at least about 50 nanometers and less than about 1 mm (and all values ​​and ranges therebetween). In another non-limiting embodiment, the nitrided surface layer has a thickness of at least about 50 nanometers and less than about 0.1 mm. Generally, the weight percent of nitrogen in the nitrided surface layer is 0.0001-5 weight percent nitrogen (and all values ​​and ranges therebetween). In one non-limiting embodiment, the weight percent of nitrogen in the nitrided surface layer is generally less than one of the major components of the rhenium-chromium metal alloy or rhenium alloy, and typically less than each of the two major components of the rhenium-chromium metal alloy or rhenium alloy. For example, when a rhenium-chromium metal alloy or a rhenium alloy is nitrided, the weight percentage of nitrogen in the nitrided surface layer is less than the weight percentage of rhenium in the nitrided surface layer.As can be understood, the entire outer surface of the rhenium-chromium metal alloy or rhenium alloy can be nitrided, or a portion of the outer surface of the rhenium-chromium metal alloy or rhenium alloy can be nitrided. Nitriding only selected portions of the outer surface of the rhenium-chromium metal alloy or rhenium alloy can be used to obtain different surface properties of the rhenium-chromium metal alloy or rhenium alloy, but this is not required. As can be understood, the finally formed rhenium-chromium metal alloy can include a nitrided outer surface. The nitriding process of the rhenium-chromium metal alloy or rhenium alloy can be used to increase the surface hardness and / or wear resistance of the medical device and / or inhibit or prevent discoloration of the rhenium-chromium metal alloy or rhenium alloy (such as discoloration due to oxidation). For example, the nitriding process can be used to increase the wear resistance of articular surfaces or surface wear on rhenium-chromium metal alloys or rhenium alloys used in medical devices to extend the life of the medical device, and / or to extend the wear life of mating surfaces on the medical device, and / or to reduce particle generation from use of the medical device, and / or to maintain the outer surface appearance of the rhenium-chromium metal alloy or rhenium alloy on the medical device.

[0047] In another and / or alternative non-limiting aspect of the present disclosure, the rhenium-chromium metal alloy can be optionally cleaned, polished, sterilized, nitrided, etc. for final processing of the rhenium-chromium metal alloy immediately before or after it is partially or completely formed into the desired medical device.

[0048] In another and / or alternative non-limiting aspect of the present disclosure, the use of the above-mentioned rhenium-chromium metal alloy or rhenium alloy to partially or completely form a medical device can be used to increase the strength and / or hardness and / or durability of the medical device compared to stainless steel or chromium-cobalt alloy or titanium alloy, and thus a smaller amount of rhenium-chromium metal alloy can be used in the medical device to achieve similar strength compared to a medical device formed of a different metal. In this manner, the resulting medical device can be made smaller and less bulky by using the rhenium-chromium metal alloy or rhenium alloy without sacrificing the strength and durability of the medical device. Such a medical device can have a smaller profile and therefore can be inserted into smaller areas, openings, and / or passages. The rhenium-chromium metal alloy or rhenium alloy can also increase the radial strength of the medical device. For example, the thickness of the wall of the medical device and / or the wire used to at least partially form the medical device can be reduced to achieve similar or improved radial strength compared to a thick-walled medical device formed of stainless steel, titanium alloy, or cobalt and chromium alloy. The rhenium-chromium metal alloy or rhenium alloy can also improve the stress-strain properties, bendability, and flexibility of the medical device, thus extending the life of the medical device. For example, the medical device can be used in areas where the medical device is bent. Due to the improved physical properties of the medical device from the rhenium-chromium metal alloy or rhenium alloy, the medical device has improved resistance to fracture in such frequent bending environments. In addition, or alternatively, the improved bendability and flexibility of the medical device due to the use of the rhenium-chromium metal alloy or rhenium alloy can allow the medical device to be more easily inserted into various areas of the body. The rhenium-chromium metal alloy or rhenium alloy can also reduce the degree of recoil during crimping and / or expansion of the medical device.For example, the medical device better maintains the crimped configuration and / or better maintains the expanded configuration due to the use of rhenium-chromium metal alloy or rhenium alloy. Thus, when the medical device is attached to the delivery device when it is crimped, the medical device better maintains its smaller profile during insertion of the medical device into various regions of the body. Also, the medical device better maintains the expanded profile after expansion to facilitate the success of the medical device in the treatment region. In addition to the improved physical properties of the medical device by using rhenium-chromium metal alloy or rhenium alloy, the rhenium-chromium metal alloy or rhenium alloy has improved radiopaque properties compared to standard materials such as stainless steel or cobalt-chromium alloy, thus reducing or eliminating the need to use marker materials on the medical device.

[0049] In another and / or alternative non-limiting aspect of the present disclosure, the medical device can optionally contain and / or be coated with one or more agents that facilitate the success of the medical device and / or treatment area. The term "agent" includes, but is not limited to, substances, pharmaceuticals, biologicals, veterinary products, drugs, and analogs or derivatives that are otherwise formulated and / or designed to prevent, inhibit, and / or treat one or more clinical and / or biological events and / or promote healing. Non-limiting examples of clinical events that may be addressed by one or more agents include viral, fungal and / or bacterial infections, vascular diseases and / or disorders, digestive diseases and / or disorders, reproductive diseases and / or disorders, lymphatic system diseases and / or disorders, cancer, implant rejection, pain, nausea, swelling, arthritis, bone diseases and / or disorders, organ failure, immune diseases and / or disorders, cholesterol problems, blood diseases and / or disorders, lung diseases and / or disorders, heart diseases and / or disorders, brain diseases and / or disorders, nerve pain diseases and / or disorders, kidney diseases and / or disorders, ulcers, liver diseases and / or disorders, The medical device may be used to treat, for example, chronic conditions, chronic pain, and / or other conditions, including, but not limited to, chronic conditions, bowel conditions and / or disorders, gallbladder conditions and / or disorders, pancreatic conditions and / or disorders, psychological disorders, respiratory conditions and / or disorders, glandular conditions and / or disorders, skin conditions and / or disorders, hearing conditions and / or disorders, oral conditions and / or disorders, nasal conditions and / or disorders, eye conditions and / or disorders, fatigue, genetic conditions and / or disorders, burns, scars and / or scars, trauma, weight conditions and / or disorders, toxic conditions and / or disorders, hair loss, convulsions, muscle spasms, tissue repair, nerve repair, nerve regeneration, and / or the like. The types and / or amounts of agents included in and / or coated onto the medical device may vary. When more than one agent is included in and / or coated onto the medical device, the amounts of the two or more agents may be the same or different.The one or more agents can be coated and / or impregnated onto the medical device by a variety of mechanisms, including, but not limited to, spraying (e.g., atomized spray techniques), flame spray coating, powder deposition, dip coating, flow coating, dip spin coating, roll coating (direct and reverse), sonication, brushing, plasma deposition, deposition by evaporation, MEMS techniques, and spin-on deposition. In another and / or alternative non-limiting embodiment of the present disclosure, the type and / or amount of agent included on, within, and / or in association with the medical device is generally selected for the treatment of one or more medical procedures. The amount of two or more agents used on, within, and / or in association with the medical device can be the same or different. The one or more agents, when used on and / or in the medical device, can optionally be released in a controlled manner, so that a desired dose of the agent is provided to the problem area to be treated over a sustained period of time. As can be appreciated, a controlled release of one or more agents on the medical device is not necessarily required and / or desirable. Thus, one or more agents on and / or within the medical device may be uncontrollably released from the medical device during and / or after insertion of the medical device into a treatment area. It may also be understood that one or more agents on and / or within the medical device may be controllably released from the medical device and one or more agents on and / or within the medical device may be uncontrollably released from the medical device. It may also be understood that one or more agents on and / or within one region of the medical device may be controllably released from the medical device and one or more agents on and / or within the medical device may be uncontrollably released from another region of the medical device.Thus, the medical device can be designed such that 1) all of the agents on and / or within the medical device are controllably released, 2) some of the agents on and / or within the medical device are controllably released and some of the agents on the medical device are non-controllably released, or 3) none of the agents on and / or within the medical device are controllably released. The medical device can also be designed such that the release rates of one or more agents from the medical device are the same or different. The medical device can also be designed such that the release rates of one or more agents from one or more regions on the medical device are the same or different. Non-limiting configurations that can be used to control the release of one or more agents from the medical device include 1) at least partially coating one or more agents with one or more polymers, 2) at least partially incorporating and / or at least partially encapsulating one or more agents in one or more polymers, and / or 3) inserting one or more agents into pores, passages, cavities, etc. in the medical device and at least partially coating or covering such pores, passages, cavities, etc. with one or more polymers. As can be appreciated, other or additional configurations can be used to control the release of one or more agents from the medical device. The one or more polymers, when used to at least partially control the release of one or more agents from the medical device, can be porous or non-porous. The one or more agents can be inserted and / or applied to one or more surface structures and / or microstructures on the medical device and / or can be used to at least partially form one or more surface structures and / or microstructures on the medical device. Thus, the one or more agents on the medical device can be 1) coated on one or more surface regions of the medical device, 2) inserted and / or impregnated into one or more surface structures and / or microstructures, etc. of the medical device, and / or 3) formed or included in at least a portion of the structure of the medical device.When one or more agents are coated on the medical device, the one or more agents can be 1) coated directly onto one or more surfaces of the medical device, 2) mixed with one or more coating polymers or other coating materials and then at least partially coated onto one or more surfaces of the medical device, 3) at least partially coated onto a surface of another coating material that is at least partially coated onto the medical device, and / or 4) a) at least partially encapsulated between a surface or region of the medical device and one or more other coating materials, and / or b) at least partially encapsulated between two or more other coating materials. As can be appreciated, many other coating configurations can additionally or alternatively be used. When one or more agents are optionally inserted and / or impregnated into one or more internal structures, surface structures, and / or microstructures of the medical device, 1) one or more other coating materials can be at least partially applied onto one or more internal structures, surface structures, and / or microstructures of the medical device, and / or 2) one or more polymers can be combined with the one or more agents. Thus, the one or more agents can be 1) embedded within the structure of the medical device, 2) positioned within one or more internal structures of the medical device, 3) encapsulated between two polymer coatings, 4) encapsulated between a base structure and a polymer coating, 5) mixed within the base structure of the medical device including at least one polymer coating, or 6) a combination of one or more of 1, 2, 3, 4, and / or 5. Additionally or alternatively, the one or more coatings of the one or more polymers on the medical device can include 1) one or more coatings of a non-porous polymer, 2) one or more coatings of a combination of one or more porous polymers and one or more non-porous polymers, 3) one or more coatings of a porous polymer, or 4) a combination of one or more of options 1, 2, and 3.

[0050] In another and / or alternative non-limiting aspect of the present disclosure, different drugs can be optionally located within and / or between different polymer coating layers and / or on the structure of the medical device. As can also be understood, many other and / or additional coating combinations and / or structures can be used. The concentration of one or more drugs, the type of polymer, the type and / or shape of the internal structure within the medical device, and / or the coating thickness of one or more drugs can be used to control the release time, release rate, and / or dosage of one or more drugs, although other or additional combinations can be used. Thus, the combinations of drugs and polymer systems and locations on the medical device can be numerous. As can also be understood, one or more drugs can be deposited on the top surface of the medical device to provide an initial uncontrolled burst effect of one or more drugs before 1) a controlled release of one or more drugs through one or more layers of the polymer system including one or more non-porous polymers, and / or 2) an uncontrolled release of one or more drugs through one or more layers of the polymer system. The one or more drugs and / or polymers may be coated onto the medical device by a variety of mechanisms, including, but not limited to, spraying (e.g., atomized spray techniques), dip coating, roll coating, sonication, brushing, plasma deposition, and / or deposition by vapor deposition.

[0051] In another and / or alternative non-limiting aspect of the present disclosure, various polymers can be optionally coated on a medical device and / or used to form at least a portion of a medical device. One or more polymers can be used on a medical device for a variety of reasons, including, but not limited to, 1) forming a portion of the medical device, 2) improving the physical properties of the medical device (e.g., improving strength, improving durability, improving biocompatibility, reducing friction, etc.), 3) forming a protective coating on one or more surface structures on the medical device, 4) at least partially forming one or more surface structures on the medical device, and / or 5) at least partially controlling the release rate of one or more agents from the medical device. As can be appreciated, one or more polymers can have other or additional uses on the medical device. One or more polymers can be porous, non-porous, biostable, biodegradable (i.e., dissolve, degrade, absorb in the body, or any combination thereof), and / or biocompatible. When the medical device is coated with one or more polymers, the polymers can include 1) one or more coatings of a non-porous polymer, 2) one or more coatings of a combination of one or more porous polymers and one or more non-porous polymers, 3) one or more coatings of one or more porous polymers and one or more coatings of one or more non-porous polymers, 4) one or more coatings of a porous polymer, or 5) one or more combinations of options 1, 2, 3, and 4. The thickness of the one or more polymer layers can be the same or different. When one or more polymer layers are coated on at least a portion of the medical device, the one or more coatings can be applied by a variety of techniques, including, but not limited to, vapor and / or plasma deposition, spraying, dip coating, roll coating, sonication, atomization, brushing, and / or the like, although other or additional coating techniques can be used.The one or more polymers that can be coated on and / or used to at least partially form the medical device can be polymers that are considered to be biodegradable, bioabsorbable, or bioerodible, polymers that are considered to be biostable, and / or polymers that can be modified to be biodegradable and / or bioabsorbable. The thickness of each polymer layer is generally at least about 0.01 μm and generally less than about 150 μm (e.g., 0.01 μm to 150 μm, and all values ​​and ranges therebetween), although other thicknesses can be used. In one non-limiting embodiment, the thickness of the polymer layer and / or drug layer is about 0.02 to 75 μm, more specifically about 0.05 to 50 μm, and even more specifically about 1 to 30 μm. As can be appreciated, other thicknesses can be used.

[0052] In another and / or alternative non-limiting aspect of the present disclosure, the medical device can include and / or be coated with one or more agents, which, if included, are the same or different in different regions of the medical device and / or have different amounts and / or concentrations in different regions of the medical device. For example, the medical device can be 1) coated with and / or include one or more biological substances in at least one portion of the medical device and at least another portion of the medical device is not coated with an agent and / or includes an agent, 2) coated with and / or include one or more biological substances in at least one portion of the medical device that are different from the one or more biological substances in at least another portion of the medical device, and / or 3) coated with and / or include one or more biological substances in a concentration in at least one portion of the medical device that is different from the concentration of the one or more biological substances in at least another portion of the medical device.

[0053] In another and / or alternative non-limiting aspect of the present disclosure, one or more portions of the medical device can optionally 1) contain the same or different agents, 2) contain the same or different amounts of one or more agents, 3) contain the same or different polymer coatings, 4) contain the same or different coating thicknesses of the one or more polymer coatings, 5) one or more portions of the medical device can controllably release and / or uncontrollably release one or more agents, and / or 6) one or more portions of the medical device can controllably release one or more agents and one or more portions of the medical device can uncontrollably release one or more agents.

[0054] In another and / or alternative non-limiting aspect of the present disclosure, one or more surfaces of the medical device can be optionally treated to achieve the desired coating properties of the one or more drugs and one or more polymers coated on the medical device. Such surface treatment techniques include, but are not limited to, cleaning, buffing, smoothing, nitriding, annealing, swaging, rolling, cold working, etching (chemical etching, plasma etching, etc.), and the like. As can be appreciated, other or additional surface treatment processes can be used prior to coating one or more drugs and / or polymers on the surface of the medical device.

[0055] In another and / or alternative non-limiting aspect of the present disclosure, the medical device can optionally include a marker material that facilitates allowing the medical device to be properly positioned in the body passage. The marker material is typically designed to be visible to electromagnetic waves (e.g., x-rays, microwaves, visible light, infrared waves, ultraviolet waves, etc.), sound waves (e.g., ultrasound, etc.), magnetic waves (e.g., MRI, etc.), and / or other types of electromagnetic waves (e.g., microwaves, visible light, infrared waves, ultraviolet waves, etc.). The marker material can form all or a portion of the medical device and / or can be coated on one or more portions of the medical device (e.g., the flare portion and / or the body portion, the end of the medical device, at or near the transition of the body portion and the flare portion, etc.). The location of the marker material can be at one or more locations on the medical device. The size of one or more areas containing the marker material can be the same or different. The marker materials can be spaced apart from each other at a prescribed distance to form ruler-like markings on the medical device to facilitate positioning of the medical device in the body passage. The marker material may be a rigid or flexible material. The marker material may be a biostable or biodegradable material.

[0056] In another and / or alternative non-limiting aspect of the present disclosure, the medical device or one or more regions of the medical device can optionally be constructed through the use of one or more microelectromechanical manufacturing (MEMS) techniques (e.g., micromachining, laser micromachining, micromolding, etc.), although other or additional manufacturing techniques can be used.

[0057] In another and / or alternative non-limiting aspect of the present disclosure, the medical device can optionally include one or more surface structures (e.g., pores, passages, holes, ribs, slots, notches, protrusions, teeth, needles, depressions, holes, grooves, etc.) These structures can be formed at least in part by MEMS (e.g., micromachining, etc.) techniques and / or other types of techniques.

[0058] In another and / or alternative non-limiting aspect of the present disclosure, the medical device can optionally include one or more microstructures (e.g., microneedles, micropores, microcylinders, microcones, micropyramids, microtubes, microparallel hexahedrons, microprisms, microhemispheres, teeth, ribs, ridges, ratchets, hinges, zippers, cable ties, etc.) on the surface of the medical device. 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.) that is about 2 mm or less, typically about 1 mm or less. As can be understood, when a medical device includes one or more surface structures, 1) all of the surface structures can be microstructures, 2) all of the surface structures can be non-microstructures, or 3) a portion of the surface structures can be microstructures and a portion can be non-microstructures. Typically, the microstructures (if formed) extend from or into the exterior surface no more than about 400 microns (0.01-400 microns, and all values ​​and ranges therebetween), more typically less than about 300 microns, and more typically no more than about 15-250 microns, although other sizes can be used. The microstructures can be clustered together or dispersed across the surface of the medical device. Microstructures and / or surface structures of similar shapes and / or sizes can be used, or microstructures of different shapes and / or sizes can be used. If one or more surface structures and / or microstructures are designed to extend from the surface of the medical device, the one or more surface structures and / or microstructures can be formed in an extended position and / or designed to extend from the medical device during and / or after deployment of the medical device in the treatment area. The microstructures and / or surface structures can be designed to contain and / or be fluidly connected to passageways, cavities, etc., although this is not required. The one or more surface structures and / or microstructures may, but need not, be used to engage and / or penetrate surrounding tissue or organs once the medical device is positioned on and / or within a patient. The one or more surface structures and / or microstructures may be used to facilitate forming and maintaining the shape of the medical device.In one non-limiting embodiment, the one or more surface structures and / or microstructures can be at least partially formed from a drug and / or can be formed from a polymer. One or more of the surface structures and / or microstructures can include one or more internal passages that can include one or more materials (e.g., drugs, polymers, etc.), but this is not required. The one or more coatings and / or the one or more surface structures and / or microstructures of the medical device can be used for various purposes, such as, but not limited to, 1) increasing the binding and / or adhesion of one or more drugs, adhesives, marker materials, and / or polymers to the medical device, 2) modifying the appearance or surface characteristics of the medical device, and / or 3) controlling the release rate of one or more drugs. The one or more microstructures and / or surface structures can be biostable, biodegradable, etc. The medical device or one or more regions of the medical device can be at least partially covered and / or filled with a protective material to at least partially protect one or more regions of the medical device and / or one or more microstructures and / or surface structures of the medical device from damage. The protective material can include one or more polymers pre-identified above. The protective material can be 1) biostable and / or biodegradable, and / or 2) porous and / or non-porous.

[0059] In another and / or alternative aspect of the present disclosure, the medical device may be an expandable device that can optionally be expanded by the use of some other device (e.g., a balloon, etc.) The expandable medical device may be fabricated from a material that has no or substantially no shape memory properties.

[0060] In another and / or alternative non-limiting aspect of the present disclosure, near net processing is optionally provided for frames or other metal components of medical devices.

[0061] In another and / or alternative non-limiting aspect of the present disclosure, the rhenium-chromium metal alloy or rhenium alloy described above can be formed into rods, tubes, green parts, near-net parts, etc., by sintering, cold isostatic pressing (CIP), and / or hot isostatic pressing (HIP) processes. The particle size of the metal particles used in the sintering, cold isostatic pressing (CIP), and / or hot isostatic pressing (HIP) processes is generally less than about 100 mesh (e.g., less than 150 microns, 2-80 microns, 5-40 microns). The metal particles can be high purity metal particles formed from a single element and / or high purity metal particles formed from two of more elements. The purity of the metal particles should be selected so that the metal particles contain very low levels of elemental impurities (e.g., 99+% purity, 99.5+%, 99.99+% purity). In one non-limiting embodiment, the rods, tubes, green parts, near net parts, etc. are formed by a sintering process. The sintering process is performed at a temperature of at least 1600°C (e.g., 1600-2600°C, and all values ​​and ranges therebetween). The sintering process can optionally be performed in a non-oxidizing environment (e.g., hydrogen atmosphere, etc.). The sintering process can optionally be performed under vacuum or under pressures greater than 1 atm (0.0074-300 tsi, and all values ​​and ranges therebetween). In one non-limiting example, the rods, tubes, green parts, near net parts, etc. are at least partially formed from the rhenium-chromium metal alloy or rhenium alloy by a sintering process in which the sintering temperature is about 1550°C-1850°C (and all values ​​and ranges therebetween) for about 2-40 hours (and all values ​​and ranges therebetween) in a non-oxidizing environment. In another non-limiting embodiment, rods, tubes, green parts, near net parts, etc. are at least partially formed from rhenium-chromium metal alloys or rhenium alloys by a hot isostatic pressing (HIP) process.In one non-limiting configuration, the hot isostatic pressing (HIP) process is optionally carried out at a temperature between 1700° C. and 2100° C. (and all values ​​and ranges therebetween) for about 1 to 6 hours (and all values ​​and ranges therebetween). The hot isostatic pressing (HIP) process can optionally be carried out in a non-oxidizing environment (e.g., a hydrogen atmosphere, etc.). The hot isostatic pressing (HIP) process is carried out under vacuum or under pressures greater than 1 atm (0.0074 to 300 tsi, and all values ​​and ranges therebetween).

[0062] In another and / or alternative non-limiting aspect of the present disclosure, the formed rods, tubes, green parts, near-net parts, etc. of the rhenium-chromium metal alloy or rhenium alloy described above can be optionally strengthened by cold working the rhenium-chromium metal alloy or rhenium alloy. In one non-limiting embodiment, the rods, tubes, green parts, near-net parts, etc. are at least partially formed by pressing metal particles together and then sintering the metal particles pressed together. The sintered part can then be optionally pressed again to increase its mechanical strength by applying cold working to the sintered part. Generally, the temperature during the pressing process after the sintering process is 20-100°C (and all values ​​and ranges therebetween), typically 20-80°C, and more typically 20-40°C. As defined herein, cold working is performed at a temperature of 150°C or less (e.g., 10-150°C, and all values ​​and ranges therebetween). The change in shape of the repressed sintered part must be determined so that the final part (pressed, sintered, and repressed) meets the dimensional requirements of the final molded part. For rhenium-chromium metal alloys or rhenium alloys or rhenium alloys, post-sintering pressures of 1 to 300 tsi (tons per square inch) (and all values ​​and ranges therebetween) can be used.

[0063] In yet another and / or alternative non-limiting aspect of the present disclosure, a pressing of a composite of near-net or finished parts is optionally provided. While the process of pressing metal to near-net finished parts is well established, pressing composite structures formed of metal powders and polymers for the purpose of creating complex part shapes and foam-like structures is new. Similarly, using a pressing process to impart specific biological materials to a metal matrix is ​​new. In one non-limiting embodiment, a process is provided to create a metal part with predefined voids to create a trabecular or foam structure consisting of mixing metal and polymer powders, pressing the powder into a finished part or semi-finished green part, and then sintering the part through a pyrolysis process of the polymer under conditions that leave the polymer behind the metal. The resulting part has a porosity related to the size of the polymer particles and the homogeneity of the mixture at the time of pressing before sintering. In another non-limiting embodiment, a process is provided in which a polymer residue is left behind on a metal substrate after pyrolysis, where the polymer residue has some desired biological effect (e.g., masking the metal from the body by encapsulation, promoting cell binding and growth). The polymer and metal powders can be of various sizes to create multiple voids, some large to create pathways for cell growth and some small to create a rough surface to promote cell attachment.

[0064] In further and / or alternative non-limiting aspects of the present disclosure, the rhenium-chromium metal alloy or rhenium alloy used to at least partially form a medical device is first formed into a blank, rod, tube, or the like, and then finished into its final form by one or more finishing processes. The rhenium-chromium metal alloy or rhenium alloy blanks, rods, tubes, etc. can be formed by a variety of techniques including, but not limited to, 1) melting the rhenium-chromium metal alloy or rhenium alloy and / or metals forming the rhenium-chromium metal alloy or rhenium alloy (e.g., vacuum arc melting, etc.) and then extruding and / or casting the rhenium-chromium metal alloy or rhenium alloy into a blank, rod, tube, etc., 2) melting the rhenium-chromium metal alloy or rhenium alloy and / or metals forming the rhenium-chromium metal alloy or rhenium alloy and forming a metal strip and then rolling and welding the strip into a blank, rod, tube, etc., or 3) bonding a metal powder of the rhenium-chromium metal alloy or rhenium alloy and / or a metal powder forming the rhenium-chromium metal alloy or rhenium alloy into a blank, rod, tube, etc. When the rhenium-chromium metal alloy or rhenium alloy is formed into a blank, the shape and size of the blank are non-limiting. In one non-limiting process, near-net medical devices, blanks, rods, tubes, etc. can be formed from one or more ingots of metal or rhenium-chromium metal alloy. In one non-limiting process, an arc melting process (e.g., a vacuum arc melting process, etc.) can be used to form near-net medical devices, blanks, rods, tubes, etc. In another non-limiting process, rhenium powder and tungsten powder, and optionally molybdenum powder, can be placed in a crucible (e.g., a silica crucible, etc.) and heated by an induction melting furnace under a controlled atmosphere (e.g., a vacuum environment, a carbon monoxide environment, a hydrogen and argon environment, helium, argon, etc.) to form near-net medical devices, blanks, rods, tubes, etc.It can be appreciated that other or additional processes can be used to form the rhenium-chromium metal alloy or rhenium alloy.

[0065] In further and / or alternative non-limiting aspects of the present disclosure, the near-net medical device, blank, rod, tube, etc. can be resized to the desired dimensions of the medical device. In one non-limiting embodiment, the cross-sectional area or diameter of the near-net medical device, blank, rod, tube, etc. is reduced to the final near-net medical device, blank, rod, tube, etc. dimensions by a single step or series of steps. The reduction in the outer cross-sectional area or diameter of the near-net medical device, blank, rod, tube, etc. can be obtained by centerless grinding, turning, electropolishing, drawing, grinding, laser cutting, shaving, polishing, EDM cutting, etc. The outer cross-sectional area or diameter size of the near-net medical device, blank, rod, tube, etc. can be reduced by the use of one or more drawing operations, but this is not required. During the drawing operation, care must be taken to avoid the formation of microcracks in the near-net medical device, blank, rod, tube, etc. during the reduction in the outer cross-sectional area or diameter of the near-net medical device, blank, rod, tube, etc.

[0066] The use of the above-mentioned rhenium-chromium metal alloys or rhenium alloys to form all or part of a medical device can provide several advantages over medical devices formed from other materials, including, but not limited to:

[0067] · Because the rhenium-chromium metal alloy or rhenium alloy has increased strength and / or hardness compared to stainless steel or chromium-cobalt alloy or titanium alloy, less of the rhenium-chromium metal alloy can be used in the medical device to achieve similar strength compared to medical devices formed of different metals. Thus, the resulting medical device can be made smaller and less bulky by using the rhenium-chromium metal alloy or rhenium alloy without sacrificing the strength and durability of the medical device. The medical device can also have a smaller profile and therefore can be inserted into smaller areas, openings, and / or passageways. Thinner struts of the rhenium-chromium metal alloy to form the frame or other portion of the medical device can be used to form the frame or other portion of the medical device with strength that would require thicker struts or other structures of the medical device if formed by stainless steel, chromium-cobalt alloy, or titanium alloy.

[0068] The increased strength of the rhenium-chromium metal alloy or rhenium alloy also results in increased radial strength of the medical device, e.g., the wall thickness of the medical device can be thinner and achieve equivalent or improved radial strength compared to thicker walled medical devices made of stainless steel, cobalt and chromium alloys, or titanium alloys.

[0069] The rhenium-chromium metal alloy or rhenium alloy has improved stress-strain, bending, elongation, and / or flexibility properties of the medical device compared to stainless steel or chromium-cobalt alloy, thus resulting in increased life span of the medical device. For example, the medical device can be used in areas where the medical device is repeatedly bent. Due to the improved physical properties of the medical device from the rhenium-chromium metal alloy or rhenium alloy, the medical device has improved resistance to fracture in such frequent bending environments. These improved physical properties are attributable, at least in part, to the composition of the rhenium-chromium metal alloy or rhenium alloy, the grain size of the rhenium-chromium metal alloy or rhenium alloy, the carbon, oxygen, and nitrogen content of the rhenium-chromium metal alloy or rhenium alloy, and / or the carbon / oxygen ratio of the rhenium-chromium metal alloy or rhenium alloy.

[0070] The rhenium-chromium metal alloy or rhenium alloy has a reduced degree of recoil during crimping and / or expansion of the medical device compared to stainless steel or chromium-cobalt alloy or titanium alloy. Medical devices formed with the rhenium-chromium metal alloy or rhenium alloy better maintain their crimped configuration and / or better maintain their expanded configuration after expansion due to the use of the rhenium-chromium metal alloy or rhenium alloy. Thus, if the medical device is attached to a delivery device when the medical device is crimped, the medical device better maintains its smaller profile during insertion of the medical device into the body passageway. Also, the medical device better maintains its expanded profile after expansion to facilitate successful delivery of the medical device in the treatment area.

[0071] The use of rhenium-chromium metal alloys in medical devices results in the medical device conforming better to irregularly shaped body passages when expanded in the body passage compared to medical devices formed from stainless steel, chromium-cobalt alloys, or titanium alloys.

[0072] The rhenium-chromium metal alloy or rhenium alloy has improved radiopacity compared to standard materials such as stainless steel or cobalt-chromium alloys, thereby reducing or eliminating the need for marker materials in medical devices. For example, the rhenium-chromium metal alloy or rhenium alloy is at least about 10-20% more radiopaque than stainless steel or cobalt-chromium alloys.

[0073] Rhenium-chromium metal alloys or rhenium alloys have improved fatigue ductility when subjected to cold working compared to cold working of stainless steels, chromium-cobalt alloys, or titanium alloys.

[0074] Rhenium-chromium metal alloys or rhenium alloys have improved durability compared to stainless steels, chromium-cobalt alloys, or titanium alloys.

[0075] · Rhenium-chromium metal alloys or rhenium alloys have improved hydrophilicity compared to stainless steels, chromium-cobalt alloys, or titanium alloys.

[0076] Rhenium-chromium metal alloys or rhenium alloys have reduced ion release in body passageways compared to stainless steel, chromium-cobalt alloys, or titanium alloys.

[0077] Rhenium-chromium metal alloys or rhenium alloys are less irritating to the body than stainless steel, cobalt-chromium alloys, or titanium alloys, and therefore may reduce inflammation, speed healing, and increase the success rate of medical devices. When a medical device is expanded in a body passageway, minor damage may occur inside the passageway. As the body begins to heal such minor damage, the body will have less adverse reactions to the presence of the rhenium-chromium alloys or rhenium alloys compared to other metals such as stainless steel, cobalt-chromium alloys, or titanium alloys.

[0078] Medical devices including expandable metal frames formed at least in part from rhenium-chromium metal alloys or rhenium alloys exhibit reduced recoil, improved bending compliance, and greater radial strength compared to expandable frames formed from stainless steel, cobalt-chromium alloys, and TiAlV alloys, thereby providing the following non-limiting advantages compared to expandable frames formed from stainless steel, cobalt-chromium alloys, or TiAlV alloys:1) formation of a frame for a medical device having thinner posts, struts, and / or strut joints, which results in i) safer vascular access when inserting a medical device through a body passageway to a treatment area, and / or ii) reduced risk of bleeding and / or damage to the body passageway and / or treatment area when the medical device is delivered to and / or expanded at the treatment area; 2) i) reduced trauma to the body passageway (e.g., blood vessels, aortic arch trauma, etc.) during insertion and / or expansion of the medical device at the treatment area, and / or ii) easier deliverability of the medical device to the treatment area, which may result in reduced risk of neurological complications - stroke; 3) i) reduced crimp profile size; ii) improved conformability of the expanded medical device at the treatment area after expansion at the treatment area; iii) increased radial strength of the frame of the medical device after expansion at the treatment area; iv) requiring only a single crimping cycle to crimp the medical device onto a balloon catheter or other type of delivery device. v) reducing the incidence of damage to components of the medical device (e.g., struts, posts, strut joints, and / or other components of the expandable frame, leaflets, skirts, coatings, etc.) during crimping, expansion, and operation of the medical device; vi) increasing the effective orifice area (EOA) of the medical device after expansion of the medical device; vi) reducing pulmonary valve regurgitation (PVR) after expansion of the medical device in the treatment area; and / or vii) requiring only a single expansion cycle of the balloon on the balloon catheter or other expansion mechanism to fully expand the medical device; and / or 4) creating a medical device with superior material biological properties to i) improve tissue adhesion and / or growth on or around the medical device, ii) reduce adverse tissue reactions with the medical device, iii) reduce toxicity of the medical device, iv) potentially reduce intravalve thrombosis during the life of the medical device, and / or v) reduce the incidence of infection during the life of the medical device.

[0079] Expandable medical devices (e.g., expandable heart valves, stents, etc.) comprising rhenium-chromium metal alloys or rhenium alloys according to the present disclosure overcome several unmet needs that exist in expandable medical devices formed from cobalt-chromium alloys, TiAlV alloys, and stainless steels. Such unmet needs addressed by the medical device according to the present disclosure include: 1) eliminating the need to form large holes in large arterial or other vessels to initially insert a crimped medical device into an atrial or other vessel, thereby reducing the incidence of fatal bleeding during treatment; 2) creating medical devices (e.g., stents, prosthetic heart valves, etc.) with a reduced crimp profile that is smaller than medical devices formed from cobalt-chromium alloys, TiAlV alloys, and stainless steels, thereby allowing the medical device to be delivered and implanted into or through abnormally shaped heart valves due to heart valve firing and / or arterial vessel firing and / or plaque; 3) providing a reniform stent that better conforms to the shape of the abnormally shaped heart valve orifice upon expansion of the prosthetic heart valve compared to conventional prosthetic heart valves formed from cobalt-chromium alloys, TiAlV alloys, and stainless steels. 3) reducing the incidence of paravalvular regurgitation and / or other types of regurgitation around an implanted medical device when the medical device is expanded in the treatment area by using a frame formed of a rhenium-chromium metal alloy or a rhenium alloy, thereby reducing the incidence of stroke and / or increasing the incidence of successful implantation of the medical device; 4) improving the radial strength of the expanded struts, posts, and / or strut joints in the expandable frame, as well as the strength of the expandable frame itself after expansion of the medical device; 5) reducing the amount of recoil of the expandable frame during crimping and / or expansion of the expandable frame of the medical device; 6) allowing the medical device to be used in hearts having permanent pacemakers; 7) reducing the incidence of minor strokes during insertion and operation of the medical device in the treatment area; 8) reducing the incidence of coronary ostium obstruction; and 9) improving foreshortening.10) further reducing aortic valve calcification and / or calcification in the blood vessel after implantation of the medical device; 11) reducing the need for multiple crimping cycles when inserting the medical device into a catheter or other type of delivery system; 12) reducing the incidence of frame / stent fracture during crimping and / or expansion of the medical device; 13) reducing the incidence of biofilm-endocarditis after implantation of the medical device; 14) reducing allergic reactions to the medical device after implantation of the medical device; 15) improving the hydrophilicity of the medical device to improve tissue growth on and / or around the implanted medical device; 16) reducing the magnetic susceptibility of the medical device; 17) reducing toxicity of the medical device; 18) reducing the amount of metal ion release from the medical device; and / or 19) extending the life of the leaflets and / or stents / frames and / or other components of the medical device after insertion of the medical device.

[0080] One non-limiting object of the present disclosure is to provide a rhenium-chromium metal alloy according to the present disclosure that can be used to partially or completely form a medical device.

[0081] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device formed partially or completely from the rhenium-chromium metal alloy or rhenium alloy of the present disclosure, which medical device has improved surgical success rates.

[0082] Another and / or alternative non-limiting object of the present disclosure is to provide methods and processes for forming rhenium-chromium metal alloys or rhenium alloys in accordance with the present disclosure that inhibit or prevent the formation of microcracks during processing of the rhenium-chromium metal alloy or rhenium alloy.

[0083] Another and / or alternative non-limiting object of the present disclosure is the provision of medical devices formed partially or completely from rhenium-chromium metal alloys or rhenium alloys according to the present disclosure, wherein the medical devices have improved physical properties.

[0084] Another and / or alternative non-limiting object of the present disclosure is the provision of a medical device formed at least in part from a rhenium-chromium metal alloy or rhenium alloy according to the present disclosure, wherein the medical device has increased strength and / or hardness.

[0085] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device at least partially comprising a rhenium-chromium metal alloy or rhenium alloy according to the present disclosure, which allows the medical device to be formed from less material without sacrificing strength of the medical device compared to conventional medical devices.

[0086] Another and / or alternative non-limiting object of the present disclosure is to provide methods and processes for forming rhenium-chromium metal alloys or rhenium alloys according to the present disclosure to inhibit or prevent the formation of microcracks during processing of the rhenium-chromium metal alloys or rhenium alloys into medical devices.

[0087] Another and / or alternative non-limiting object of the present disclosure is to provide methods and processes for forming rhenium-chromium metal alloys or rhenium alloys according to the present disclosure that inhibit or prevent crack propagation and / or fatigue failure of the rhenium-chromium metal alloys or rhenium alloys.

[0088] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device comprising a rhenium-chromium metal alloy or a rhenium alloy having a nitridation process to form a nitride layer on an outer surface of the rhenium-chromium metal alloy or the rhenium alloy.

[0089] Another and / or alternative non-limiting object of the present disclosure is the provision of a medical device comprising a rhenium-chromium metal alloy or a rhenium alloy, the refractive alloy having been subjected to a swaging process.

[0090] Another and / or alternative non-limiting object of the present disclosure is the provision of a medical device comprising a rhenium-chromium metal alloy or a rhenium alloy, the refractive alloy having been subjected to a cold working process.

[0091] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device comprising a rhenium-chromium metal alloy or a rhenium alloy having increased strength and / or hardness compared to stainless steel, chromium-cobalt alloy, or titanium alloy.

[0092] Another and / or alternative non-limiting object of the present disclosure is to provide a rhenium-chromium metal alloy or a medical device comprising a rhenium alloy, thereby requiring a lesser amount of the rhenium-chromium metal alloy to achieve similar strength as compared to a medical device formed of a different metal.

[0093] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device comprising a rhenium-chromium metal alloy or a rhenium alloy, which has a smaller crimp profile compared to a medical device formed of a different metal.

[0094] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device comprising a rhenium-chromium metal alloy or rhenium alloy, which has a thinner wall and yet achieves similar or improved radial strength as compared to thicker walled medical devices formed from stainless steel, chromium-cobalt alloy, or titanium alloy.

[0095] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device comprising a rhenium-chromium metal alloy or a rhenium alloy, which has improved stress-strain, bendability, elongation, and / or flexibility properties as compared to medical devices formed of stainless steel, titanium steel, or a chromium-cobalt alloy.

[0096] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device comprising a rhenium-chromium metal alloy or a rhenium alloy, which has an extended life span as compared to medical devices formed from stainless steel, titanium steel, or a chromium-cobalt alloy.

[0097] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device comprising a rhenium-chromium metal alloy or a rhenium alloy, which has a reduced degree of recoil during crimping and / or expansion of the medical device as compared to a stainless steel, a chromium-cobalt alloy, or a titanium alloy.

[0098] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device comprising a rhenium-chromium metal alloy or a rhenium alloy, which when expanded within a body passageway, better conforms to irregularly shaped body passageways as compared to medical devices formed from stainless steel, chromium-cobalt alloys, or titanium alloys.

[0099] Another and / or alternative non-limiting object of the present disclosure is the provision of a medical device comprising a rhenium-chromium metal alloy or a rhenium alloy, which has improved fatigue ductility when subjected to cold working as compared to cold working of stainless steel, chromium-cobalt alloys, or titanium alloys.

[0100] Another and / or alternative non-limiting object of the present disclosure is the provision of a medical device comprising a rhenium-chromium metal alloy or a rhenium alloy, which has improved durability as compared to stainless steel, a chromium-cobalt alloy, or a titanium alloy.

[0101] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device comprising a rhenium-chromium metal alloy or a rhenium alloy, which has enhanced hydrophilicity as compared to stainless steel, a chromium-cobalt alloy, or a titanium alloy.

[0102] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device comprising a rhenium-chromium metal alloy or a rhenium alloy, the medical device having reduced ion release in a body passageway as compared to stainless steel, a chromium-cobalt alloy, or a titanium alloy.

[0103] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device comprising a rhenium-chromium metal alloy or a rhenium alloy, which is less irritating to the body than stainless steel or cobalt chromium alloys or titanium alloys, and thus may result in less inflammation, faster healing, and increased success of the medical device.

[0104] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device comprising a rhenium-chromium metal alloy or rhenium alloy, the rhenium-chromium metal alloy or rhenium alloy comprising rhenium and chromium, and the combined weight percentage of rhenium and chromium in the rhenium-chromium metal alloy or rhenium alloy is 95% by weight to 99.999999% by weight, and all values ​​and ranges therebetween.

[0105] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device comprising a rhenium-chromium metal alloy or rhenium alloy, the rhenium-chromium metal alloy or rhenium alloy containing less than 0.1% by weight of metals and impurities.

[0106] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device comprising a rhenium-chromium metal alloy or rhenium alloy having controlled amounts of nitrogen, oxygen, and carbon to reduce microcracks in the rhenium-chromium metal alloy or rhenium alloy, the nitrogen content in the rhenium-chromium metal alloy or rhenium alloy being less than the combined content of oxygen and carbon in the rhenium-chromium metal alloy or rhenium alloy, the rhenium-chromium metal alloy or rhenium alloy having an oxygen to nitrogen atomic ratio of at least about 1.2:1, and the rhenium-chromium metal alloy or rhenium alloy having a carbon to nitrogen atomic ratio of at least about 2:1.

[0107] Another and / or alternative non-limiting object of the present disclosure is the provision of a medical device comprising a rhenium-chromium metal alloy or a rhenium alloy, at least one region of the medical device comprising at least one biological agent.

[0108] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device comprising a rhenium-chromium metal alloy or a rhenium alloy, at least one region of the medical device comprising at least one polymer.

[0109] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device comprising a rhenium-chromium metal alloy or a rhenium alloy, at least one region of the medical device comprising at least one polymer, the at least one polymer at least partially coating, encapsulating, or a combination thereof, at least one biological agent.

[0110] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device comprising a rhenium-chromium metal alloy or a rhenium alloy, at least one region of the medical device comprising at least one microstructure on an exterior surface of the medical device.

[0111] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device comprising a rhenium-chromium metal alloy or a rhenium alloy, at least one region of the medical device comprising at least one microstructure on an exterior surface of the medical device, the at least one microstructure being at least partially formed from, comprising, or is a material consisting of a polymer, a drug, or combinations thereof.

[0112] Another and / or alternative non-limiting object of the present disclosure is the provision of a medical device comprising a rhenium-chromium metal alloy or a rhenium alloy, the medical device comprising an expandable frame.

[0113] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device comprising a rhenium-chromium metal alloy or a rhenium alloy, the medical device comprising an expandable frame, the expandable frame comprising a plurality of struts.

[0114] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device comprising a rhenium-chromium metal alloy or a rhenium alloy, the medical device including an expandable frame, the expandable frame configured to be crimped to a crimped state such that a maximum outer diameter of the expandable frame when in the crimped state is less than a maximum outer diameter of the expandable frame when expanded to a fully expanded state.

[0115] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device comprising a rhenium-chromium metal alloy or a rhenium alloy, the medical device including an expandable frame, the expandable frame having a recoil of less than 5% after undergoing a first crimping process.

[0116] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device comprising a rhenium-chromium metal alloy or a rhenium alloy, the medical device including an expandable frame, the expandable frame having a recoil of less than 5% after being expanded from a crimped state to an expanded state.

[0117] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device comprising a rhenium-chromium metal alloy or rhenium alloy, wherein the rhenium-chromium metal alloy or rhenium alloy is hydrophilic, and the contact angle of a water droplet on a surface of the rhenium-chromium metal alloy or rhenium alloy is 25 to 45° (and all values ​​and ranges therebetween).

[0118] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device comprising a rhenium-chromium metal alloy or rhenium alloy, the rhenium-chromium metal alloy or rhenium alloy having a rhenium-chromium metal ... 2 The rhenium-chromium metal alloy or the major component of the rhenium alloy when inserted or implanted on or within a patient's body is as follows, the major component of the rhenium alloy being a metal within the rhenium alloy that constitutes at least 2% by weight of the rhenium-chromium metal alloy or the rhenium alloy.

[0119] Another and / or alternative non-limiting object of the present disclosure is the provision of a medical device comprising a rhenium-chromium metal alloy or rhenium alloy, wherein the rhenium-chromium metal alloy or rhenium alloy has an absolute increase in ion release per dose of the rhenium-chromium metal alloy or rhenium alloy in tissue surrounding the medical device within 50 days after being inserted or implanted on or in a patient's body.

[0120] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device comprising a rhenium-chromium metal alloy or rhenium alloy, the rhenium-chromium metal alloy or rhenium alloy comprising rhenium and chromium, wherein A) the weight percentage of rhenium in the rhenium-chromium metal alloy or rhenium alloy is at least 50 weight percent and is an alloying agent between 0 and 25 weight percent, the weight percentage of chromium in the rhenium-chromium metal alloy or rhenium alloy is at least 25 weight percent, the combined weight percentage of rhenium and chromium is at least 75 weight percent of the rhenium-chromium metal alloy or rhenium alloy, and the weight percentage of rhenium in the rhenium-chromium metal alloy or rhenium alloy is at least the weight percentage of chromium in the rhenium-chromium metal alloy or rhenium alloy. or B) the weight percentage of rhenium in the rhenium-chromium metal alloy or rhenium alloy is less than 50 weight percent, the rhenium-chromium metal alloy or rhenium alloy comprising 0.1 to 50 weight percent of an alloying agent, the alloying agent comprising one or more metals selected from the group consisting of molybdenum, bismuth, niobium, tantalum, titanium, vanadium, tungsten, manganese, zirconium, technetium, ruthenium, rhodium, hafnium, osmium, copper, yttrium, zirconium, and iridium, and the weight percentage of chromium in the rhenium-chromium metal alloy or rhenium alloy is at least 25 weight percent; and the combined weight percentage of rhenium and chromium is at least 75 weight percent of the rhenium-chromium metal alloy or rhenium alloy.

[0121] Another and / or alternative non-limiting object of the present disclosure is the provision of a medical device comprising a rhenium-chromium metal alloy or rhenium alloy, wherein the weight percent of rhenium in the rhenium-chromium metal alloy or rhenium alloy is at least 60 weight percent and the weight percent of chromium in the rhenium-chromium metal alloy or rhenium alloy is at least 30 weight percent.

[0122] Another and / or alternative non-limiting object of the present disclosure is the provision of a medical device comprising a rhenium-chromium metal alloy or rhenium alloy, wherein the weight percent of rhenium in the rhenium-chromium metal alloy or rhenium alloy is at least 64 weight percent and the weight percent of chromium in the rhenium-chromium metal alloy or rhenium alloy is at least 32.5 weight percent.

[0123] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device comprising a rhenium-chromium metal alloy or rhenium alloy, wherein an alloying agent comprises 0.1-25% by weight of the rhenium-chromium metal alloy or rhenium alloy, the alloying agent comprising one or more metals selected from the group consisting of molybdenum, bismuth, niobium, tantalum, titanium, vanadium, tungsten, manganese, zirconium, technetium, ruthenium, rhodium, hafnium, osmium, copper, yttrium, zirconium, and iridium.

[0124] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device comprising a rhenium-chromium metal alloy or rhenium alloy, wherein the alloying agent constitutes 0.1-5 weight percent of the rhenium-chromium metal alloy or rhenium alloy.

[0125] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device comprising a rhenium-chromium metal alloy or rhenium alloy, wherein the rhenium-chromium metal alloy or rhenium alloy contains 0-0.1 wt. % impurities.

[0126] Another and / or alternative non-limiting object of the present disclosure is the provision of a medical device comprising a rhenium-chromium metal alloy or rhenium alloy having controlled amounts of nitrogen, oxygen, and carbon to reduce microcracks in the rhenium-chromium metal alloy or rhenium alloy, wherein the nitrogen content in the rhenium-chromium metal alloy or rhenium alloy is less than the combined content of oxygen and carbon in the rhenium-chromium metal alloy or rhenium alloy, wherein the rhenium-chromium metal alloy or rhenium alloy has an oxygen to nitrogen atomic ratio of at least about 1.2:1, and wherein the rhenium-chromium metal alloy or rhenium alloy has a carbon to nitrogen atomic ratio of at least about 2:1.

[0127] Another and / or alternative non-limiting object of the present disclosure is the provision of a medical device comprising a rhenium-chromium metal alloy or a rhenium alloy, the medical device comprising at least one biological agent and / or at least one polymer.

[0128] Another and / or alternative non-limiting object of the present disclosure is the provision of a medical device comprising a rhenium-chromium metal alloy or a rhenium alloy, the medical device comprising at least one microstructure on an exterior surface of the medical device.

[0129] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device comprising a rhenium-chromium metal alloy or rhenium alloy, the medical device including an expandable frame formed of the rhenium-chromium metal alloy or rhenium alloy, the expandable frame including a plurality of struts, the expandable frame configured to be crimped to a crimped state such that a maximum outer diameter of the expandable frame when in the crimped state is less than a maximum outer diameter of the expandable frame when fully expanded to an expanded state.

[0130] Another and / or alternative non-limiting object of the present disclosure is the provision of a medical device comprising a rhenium-chromium metal alloy or a rhenium alloy, the medical device being an expandable stent or an expandable prosthetic heart valve.

[0131] Another and / or alternative non-limiting object of the present disclosure is to provide a method for forming a rod, tube, green part, near net part, medical device, etc., formed at least in part from a rhenium-chromium metal alloy or rhenium alloy by a forming process selected from the group consisting of a sintering process, a cold isostatic pressing (CIP) process, and a hot isostatic pressing (HIP) process, wherein the average particle size of metal particles used in the forming process is less than about 150 microns, the metal particles have a purity of at least 99%, the rhenium-chromium metal alloy or rhenium alloy comprises rhenium and chromium, A) the weight percentage of rhenium in the rhenium-chromium metal alloy or rhenium alloy is at least 50 weight percent and is an alloying agent between 0 and 25 weight percent, the weight percentage of chromium in the rhenium-chromium metal alloy or rhenium alloy is at least 25 weight percent, and the combined weight percentage of rhenium and chromium is at least 25 weight percent. % of gold by weight, and the weight percentage of rhenium in the rhenium-chromium metal alloy or rhenium alloy is greater than the weight percentage of chromium in the rhenium-chromium metal alloy or rhenium alloy, or B) the weight percentage of rhenium in the rhenium-chromium metal alloy or rhenium alloy is less than 50 weight percent, and the rhenium-chromium metal alloy or rhenium alloy comprises 0.1 to 50 weight percent of an alloying agent, the alloying agent comprising one or more metals selected from the group consisting of molybdenum, bismuth, niobium, tantalum, titanium, vanium, tungsten, manganese, zirconium, technetium, ruthenium, rhodium, hafnium, osmium, copper, yttrium, zirconium, and iridium, and the weight percentage of chromium in the rhenium-chromium metal alloy or rhenium alloy is at least 25 weight percent, and the combined weight percentage of rhenium and chromium is at least 75 weight percent of the rhenium-chromium metal alloy or rhenium alloy.

[0132] Another and / or alternative non-limiting object of the present disclosure is to provide a method for forming rods, tubes, green parts, near net parts, medical devices, and the like, wherein the forming process includes a sintering process, and the sintering process is conducted at a temperature of at least 1600° C.

[0133] Another and / or alternative non-limiting object of the present disclosure is to provide a method for forming rods, tubes, green parts, near net parts, medical devices, and the like, where the sintering process is performed in a non-oxidizing environment.

[0134] Another and / or alternative non-limiting object of the present disclosure is to provide a method for forming rods, tubes, green parts, near net parts, medical devices, and the like, where the sintering process is carried out under vacuum or under pressures greater than 1 atm.

[0135] Another and / or alternative non-limiting object of the present disclosure is to provide a method for forming rods, tubes, green parts, near net parts, medical devices, and the like, wherein the sintering process is about 2 to 40 hours.

[0136] Another and / or alternative non-limiting object of the present disclosure is to provide a method for forming rods, tubes, green parts, near net parts, medical devices, and the like, wherein the forming process includes a hot isostatic pressing (HIP) process, and the hot isostatic pressing (HIP) process is conducted at a temperature of at least 1700° C.

[0137] Another and / or alternative non-limiting object of the present disclosure is to provide a method for forming rods, tubes, green parts, near net parts, medical devices, and the like, wherein a hot isostatic pressing (HIP) process is performed in a non-oxidizing environment.

[0138] Another and / or alternative non-limiting object of the present disclosure is to provide a method for forming rods, tubes, green parts, near net parts, medical devices, and the like, where a hot isostatic pressing (HIP) process is performed under vacuum or at pressures greater than 1 atm.

[0139] Another and / or alternative non-limiting object of the present disclosure is to provide a method for forming a rod, tube, green part, near net part, medical device, etc., where the formed rod, tube, green part, near net part, medical device, etc. is subjected to cold working.

[0140] Another and / or alternative non-limiting object of the present disclosure is to provide a method for forming a rod, tube, green part, near net part, medical device, etc., where the formed rod, tube, green part, near net part, medical device, etc. is preheated to at least 1200° C. for at least 5 minutes prior to subjecting the formed rod, tube, green part, near net part, medical device, etc. to a rolling process and / or swaging.

[0141] Another and / or alternative non-limiting object of the present disclosure is to provide a rhenium-based alloy containing 10-60 atomic weight percent (atw.%) Re and containing one or more metals selected from the group consisting of Mo, Cr, Ta, Nb, Ti, and Zr.

[0142] Another and / or alternative non-limiting object of the present disclosure is to provide a rhenium-based alloy comprising 0.5-50 atw.% Re and 0.5-70 atw.% Cr.

[0143] Another and / or alternative non-limiting object of the present disclosure is to provide a rhenium-based alloy formed by powder pressing and sintering at a temperature of 1000-2500° C. for a period of 5-32 hours to achieve densification of the powder pressed starting material in a non-oxidizing environment of hydrogen, argon, hydrogen and argon, or vacuum.

[0144] Another and / or alternative non-limiting object of the present disclosure is to provide a rhenium-based alloy that is subjected to hot isostatic pressing at 1000-2500° C. in a hydrogen, argon, or hydrogen and argon environment under a pressure of 50-500 MPa.

[0145] Another and / or alternative non-limiting object of the present disclosure is for the rhenium-based alloy to be subjected to a reduction process requiring preheating at 800-2500° C. for 5-40 minutes.

[0146] Another and / or alternative non-limiting object of the present disclosure is to provide a rhenium-based alloy having a body-centered cubic (BCC) crystal structure.

[0147] Another and / or alternative non-limiting object of the present disclosure is to provide a rhenium-based alloy, wherein the elongation of the rhenium metal alloy is between 5 and 45%.

[0148] Another and / or alternative non-limiting object of the present disclosure is to provide a rhenium-based alloy having a reduction in area of ​​rhenium metal alloy formation and / or post-processing of the rhenium metal alloy of 35-80%.

[0149] Another and / or alternative non-limiting object of the present disclosure is to provide a rhenium-based alloy, wherein the yield strength of the rhenium metal alloy is between 600 and 1800 MPa.

[0150] Another and / or alternative non-limiting object of the present disclosure is to provide a rhenium-based alloy, the rhenium metal alloy having an ultimate strength of 600 to 2000 MPa.

[0151] These and other advantages will become apparent to those of ordinary skill in the art upon reading and following this description.

[0152] Although specific terminology is used in the following description for the sake of clarity, these terminologies are intended to refer only to the particular structures of the embodiments selected for illustration in the drawings, and are not intended to define or limit the scope of the present disclosure. In the drawings and the following description, it should be understood that like number designations refer to components of similar function.

[0153] The singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.

[0154] As used in the specification and claims, the term "comprising" can include "consisting of" and "consisting essentially of" embodiments. As used herein, the terms "comprise," "include," "having," "has," "can," "contain," and variations thereof are intended to be open-ended transitional phrases, terms, or words that require the presence of the specified components / steps and permit the presence of other components / steps. However, such descriptions should be construed to describe compositions or processes as "consisting of" and "consisting essentially of" the recited components / steps, which permits the presence of only the specified components / steps, along with any unavoidable impurities that may result therefrom, and excludes other components / steps.

[0155] Numerical values ​​in the specification and claims of this application should be understood to include numerical values ​​that are the same when reduced to the same number of significant figures and numerical values ​​that differ from the numerical values ​​by less than the experimental error of conventional measuring techniques of the type described in this application to determine the values.

[0156] All ranges disclosed herein are inclusive of the recited endpoints and are independently combinable (e.g., the range "2 grams to 10 grams" includes the endpoints, 2 grams and 10 grams, and all intermediate values).

[0157] The terms "about" and "approximately" can be used to include any numerical value that can be varied without changing the basic function of its value. When used in conjunction 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". In general, the terms "about" and "approximately" can refer to plus or minus 10% of the indicated number.

[0158] Percentages of elements should be assumed to be weight percent of the element stated unless expressly stated otherwise.

[0159] In one non-limiting aspect of the present disclosure, a rhenium-chromium metal alloy or rhenium alloy is provided.

[0160] In another non-limiting object of the disclosure, there is provided a rhenium-chromium metal alloy or rhenium alloy, wherein the weight percent of rhenium in the rhenium-chromium metal alloy or rhenium alloy is at least 50 weight percent, and the weight percent of chromium in the rhenium-chromium metal alloy or rhenium alloy is at least 25 weight percent.

[0161] In another non-limiting object of the present disclosure, a rhenium-chromium metal alloy or rhenium alloy is provided having controlled amounts of nitrogen, oxygen, and carbon to reduce microcracking in the rhenium-chromium metal alloy or rhenium alloy, the nitrogen content in the rhenium-chromium metal alloy or rhenium alloy being less than the combined content of oxygen and carbon in the rhenium-chromium metal alloy or rhenium alloy, the rhenium-chromium metal alloy or rhenium alloy having an oxygen to nitrogen atomic ratio of at least about 1.2:1, and the rhenium-chromium metal alloy or rhenium alloy having a carbon to nitrogen atomic ratio of at least about 2:1.

[0162] In another non-limiting aspect of the present disclosure, a rhenium-chromium metal alloy or rhenium alloy is provided, the rhenium-chromium metal alloy or rhenium alloy being used to at least partially form a medical device.

[0163] In another non-limiting aspect of the present disclosure, a rhenium-chromium metal alloy or rhenium alloy is provided, the rhenium-chromium metal alloy or rhenium alloy being used to at least partially form a medical device, at least one region of the medical device including at least one biological agent.

[0164] In another non-limiting aspect of the present disclosure, a rhenium-chromium metal alloy or rhenium alloy is provided, the rhenium-chromium metal alloy or rhenium alloy being used to at least partially form a medical device, at least one region of the medical device comprising at least one polymer.

[0165] In another non-limiting aspect of the present disclosure, a rhenium-chromium metal alloy or rhenium alloy is provided, the rhenium-chromium metal alloy or rhenium alloy being used to at least partially form a medical device, at least one region of the medical device comprising at least one polymer, the at least one polymer at least partially coating, encapsulating, or a combination thereof, at least one biological agent.

[0166] In another non-limiting aspect of the present disclosure, a rhenium-chromium metal alloy or rhenium alloy is provided, the rhenium-chromium metal alloy or rhenium alloy being used to at least partially form a medical device, and at least one microstructure is located on an outer surface of the medical device, the at least one microstructure optionally being at least partially formed from, including, or being a material consisting of a polymer, a drug, or combinations thereof.

[0167] In another non-limiting object of the disclosure, a rhenium-chromium metal alloy or rhenium alloy is provided, the rhenium-chromium metal alloy or rhenium alloy being used to at least partially form a medical device, the medical device including an expandable frame formed of the rhenium-chromium metal alloy or rhenium alloy, the expandable frame including a plurality of struts, the expandable frame optionally configured to be crimped to a crimped state such that a maximum outer diameter of the expandable frame when in the crimped state is less than a maximum outer diameter of the expandable frame when fully expanded to an expanded state, the expandable frame optionally configured to be crimped to a first the expandable frame optionally has a recoil of less than 5% (e.g., 0.1 to 4.99 and all values ​​and ranges therebetween) after being subjected to a crimping process of 0.1 to 4.99; the expandable frame optionally has a recoil of less than 5% (e.g., 0.1 to 4.99 and all values ​​and ranges therebetween) after being expanded from a crimped state to an expanded state; the rhenium-chromium metal alloy or rhenium alloy optionally has hydrophilicity, the contact angle of a water droplet on a surface of the rhenium-chromium metal alloy or rhenium alloy being 25 to 45° (e.g., 0.1 to 4.99 and all values ​​and ranges therebetween); and the rhenium-chromium metal alloy or rhenium alloy optionally has a hydrophilicity of less than 0.5 μg / cm per day. 2 Less than or equal to (for example, 0.001 to 0.5 μg / cm per day) 2 and all values ​​and ranges therebetween), where the major component comprises at least 2% by weight of the rhenium-chromium metal alloy or rhenium alloy, and the rhenium-chromium metal alloy or rhenium alloy optionally has an absolute increase in ion release per dose of the rhenium-chromium metal alloy or rhenium-chromium alloy in tissue surrounding the medical device within 50 days after being inserted or implanted on or in the patient's body.

[0168] In another non-limiting aspect of the present disclosure, a rhenium-chromium metal alloy or rhenium alloy is provided, the rhenium-chromium metal alloy or rhenium alloy being used to at least partially form a medical device, the medical device being an expandable stent or an expandable prosthetic heart valve.

[0169] Thus, it is intended that all matter contained in the above description and shown in the accompanying drawings be interpreted as illustrative and not in a limiting sense, since, among the objects made clear from the foregoing description, the above-described objects are efficiently accomplished, and certain changes may be made in the described structure without departing from the spirit and scope of the present disclosure. The present disclosure has been described with reference to preferred and alternative embodiments. Modifications and changes will become apparent to those skilled in the art upon reading and understanding the detailed description of the present disclosure provided herein. The present disclosure is intended to include all such modifications and changes insofar as they fall within the scope of the present disclosure. It is also to be understood that the following claims are intended to cover all of the general and specific features of the present disclosure described herein, as well as all statements of the scope of the present disclosure that may fall therebetween, as a matter of language.

[0170] To assist the Patent Office, and readers of this application and any resultant patent, in interpreting the claims appended hereto, Applicants do not intend that any of the appended claims or claim elements invoke 35 U.S.C. 352(f), unless the words "means for" or "step for" are expressly used in a particular claim.

[0171] (Additional Note) (Appendix 1) A rhenium-chromium metal alloy comprising rhenium and chromium, wherein A) the weight percentage of the rhenium in the rhenium-chromium metal alloy is at least 50 weight percent, the weight percentage of the chromium in the rhenium-chromium metal alloy is at least 25 weight percent, the weight percentage of an alloying agent in the rhenium-chromium metal alloy is 0-25 weight percent, the combined weight percentage of the rhenium and the chromium is at least 75 weight percent of the rhenium-chromium metal alloy, the weight percentage of the rhenium in the rhenium-chromium metal alloy is greater than the weight percentage of the chromium in the rhenium-chromium metal alloy, and the alloying agent is selected from the group consisting of molybdenum, bismuth, niobium, tantalum, titanium, vanadium, tungsten, manganese, zirconium, technetium, ruthenium, rhodium, hafnium, osmium, copper, or B) a weight percentage of the rhenium in the rhenium-chromium metal alloy is less than 50 weight percent, the rhenium-chromium metal alloy comprising 0.1-50 weight percent alloying agent, the alloying agent comprising one or more metals selected from the group consisting of molybdenum, bismuth, niobium, tantalum, titanium, vanadium, tungsten, manganese, zirconium, technetium, ruthenium, rhodium, hafnium, osmium, copper, yttrium, zirconium, and iridium, the weight percentage of the chromium in the rhenium-chromium metal alloy is at least 25 weight percent, and the combined weight percentage of the rhenium and the chromium is at least 50 weight percent of the rhenium-chromium metal alloy.

[0172] (Appendix 2) 2. The rhenium-chromium metal alloy of claim 1, wherein the weight percentage of rhenium in the rhenium-chromium metal alloy is at least 60 weight percent and the weight percentage of chromium in the rhenium-chromium metal alloy is at least 30 weight percent.

[0173] (Appendix 3) 2. The rhenium-chromium metal alloy of claim 1, wherein the weight percent of rhenium in the rhenium-chromium metal alloy is at least 64 weight percent, and the weight percent of chromium in the rhenium-chromium metal alloy is at least 32.5 weight percent.

[0174] (Appendix 4) 3. The rhenium-chromium metal alloy of claim 2, wherein the weight percent of rhenium in the rhenium-chromium metal alloy is at least 64 weight percent, and the weight percent of chromium in the rhenium-chromium metal alloy is at least 32.5 weight percent.

[0175] (Appendix 5) 2. The rhenium-chromium metal alloy of claim 1, wherein the alloying agent comprises 0.1-25% by weight of the rhenium-chromium metal alloy, the alloying agent comprising one or more metals selected from the group consisting of molybdenum, bismuth, niobium, tantalum, titanium, vanadium, tungsten, manganese, zirconium, technetium, ruthenium, rhodium, hafnium, osmium, copper, yttrium, zirconium, and iridium.

[0176] (Appendix 6) 5. The rhenium-chromium metal alloy of any one of claims 2 to 4, wherein the alloying agent constitutes 0.1 to 25% by weight of the rhenium-chromium metal alloy, the alloying agent comprising one or more metals selected from the group consisting of molybdenum, bismuth, niobium, tantalum, titanium, vanadium, tungsten, manganese, zirconium, technetium, ruthenium, rhodium, hafnium, osmium, copper, yttrium, zirconium, and iridium.

[0177] (Appendix 7) 6. The rhenium-chromium metal alloy of claim 5, wherein the alloying agent comprises 0.1-5 wt. % of the rhenium-chromium metal alloy.

[0178] (Appendix 8) 7. The rhenium-chromium metal alloy of claim 6, wherein the alloying agent comprises 0.1-5 wt. % of the rhenium-chromium metal alloy.

[0179] (Appendix 9) 2. The rhenium-chromium metal alloy of claim 1, wherein the rhenium-chromium metal alloy contains 0-0.1 wt. % impurities.

[0180] (Appendix 10) 9. The rhenium-chromium metal alloy according to any one of claims 2 to 8, wherein the rhenium-chromium metal alloy contains 0 to 0.1 wt. % of impurities.

[0181] (Appendix 11) 2. The rhenium-chromium metal alloy of claim 1, wherein the rhenium-chromium metal alloy has controlled amounts of nitrogen, oxygen, and carbon to reduce microcracking in the rhenium-chromium metal alloy, the nitrogen content in the rhenium-chromium metal alloy is less than the combined content of oxygen and carbon in the rhenium-chromium metal alloy, the rhenium-chromium metal alloy has an oxygen to nitrogen atomic ratio of at least about 1.2:1, and the rhenium-chromium metal alloy has a carbon to nitrogen atomic ratio of at least about 2:1.

[0182] (Appendix 12) 11. The rhenium-chromium metal alloy of any one of claims 2-10, wherein the rhenium-chromium metal alloy has controlled amounts of nitrogen, oxygen, and carbon to reduce microcracking in the rhenium-chromium metal alloy, the nitrogen content in the rhenium-chromium metal alloy is less than the combined content of oxygen and carbon in the rhenium-chromium metal alloy, the rhenium-chromium metal alloy has an oxygen to nitrogen atomic ratio of at least about 1.2:1, and the rhenium-chromium metal alloy has a carbon to nitrogen atomic ratio of at least about 2:1.

[0183] (Appendix 13) 2. A medical device formed at least in part from the rhenium-chromium metal alloy of claim 1.

[0184] (Appendix 14) 13. A medical device formed at least in part from the rhenium-chromium metal alloy of any one of claims 2-12.

[0185] (Appendix 15) 14. The medical device of claim 13, wherein at least one region of the medical device comprises at least one biological agent.

[0186] (Appendix 16) 15. The medical device of claim 14, wherein at least one region of the medical device comprises at least one biological agent.

[0187] (Appendix 17) 14. The medical device of claim 13, wherein at least one region of the medical device comprises at least one polymer.

[0188] (Appendix 18) 18. The medical device of any one of claims 14-17, wherein at least one region of the medical device comprises at least one polymer.

[0189] (Appendix 19) 16. The medical device of claim 15, wherein at least one region of the medical device comprises at least one polymer, and the at least one polymer at least partially coats, encapsulates, or a combination thereof, the at least one biological agent.

[0190] (Appendix 20) 19. The medical device of any one of claims 16-18, wherein at least one region of the medical device comprises at least one polymer, and the at least one polymer at least partially coats, encapsulates, or a combination thereof, the at least one biological agent.

[0191] (Appendix 21) 14. The medical device of claim 13, further comprising at least one microstructure on an exterior surface of the medical device.

[0192] (Appendix 22) 21. The medical device of any one of claims 14-20, further comprising at least one microstructure on an exterior surface of the medical device.

[0193] (Appendix 23) 22. The medical device of claim 21, wherein the at least one microstructure is at least partially formed of, comprises, or is a material consisting of a polymer, a drug, or a combination thereof.

[0194] (Appendix 24) 23. The medical device of claim 22, wherein the at least one microstructure is at least partially formed of, comprises, or is a material consisting of a polymer, a drug, or a combination thereof.

[0195] (Appendix 25) 14. The medical device of claim 13, wherein the medical device comprises an expandable frame formed at least in part from the rhenium-chromium metal alloy, the expandable frame comprising a plurality of struts, and the expandable frame configured to be crimped to the crimped state such that a maximum outer diameter of the expandable frame when in the crimped state is less than a maximum outer diameter of the expandable frame when fully expanded to an expanded state.

[0196] (Appendix 26) 25. The medical device of any one of claims 14-24, wherein the medical device comprises an expandable frame formed at least in part from the rhenium-chromium metal alloy, the expandable frame comprising a plurality of struts, and the expandable frame configured to be crimped to the crimped state such that a maximum outer diameter of the expandable frame in the crimped state is less than a maximum outer diameter of the expandable frame when fully expanded to an expanded state.

[0197] (Appendix 27) 26. The medical device of claim 25, wherein the expandable frame has a) less than 5% recoil after undergoing a first crimping process, and / or b) less than 5% recoil after being expanded from the crimped state to the expanded state.

[0198] (Appendix 28) 27. The medical device of claim 26, wherein the expandable frame has a) less than 5% recoil after undergoing a first crimping process, and / or b) less than 5% recoil after being expanded from the crimped state to the expanded state.

[0199] (Appendix 29) 14. The medical device of claim 13, wherein the rhenium-chromium metal alloy on the medical device is hydrophilic, and the contact angle of a water droplet on the surface of the rhenium-chromium metal alloy is 25 to 45 degrees.

[0200] (Appendix 30) 29. The medical device of any one of claims 14 to 28, wherein the rhenium-chromium metal alloy on the medical device is hydrophilic, and the contact angle of a water droplet on the surface of the rhenium-chromium metal alloy is 25 to 45 degrees.

[0201] (Appendix 31) The rhenium-chromium metal alloy on the medical device is at least 0.5 μg / cm per day. 2 14. The medical device of claim 13, having the following maximum ion release of a major component of the rhenium-chromium metal alloy when inserted or implanted on or within a patient's body, wherein the major component comprises at least 2% by weight of the rhenium-chromium metal alloy.

[0202] (Appendix 32) The rhenium-chromium metal alloy on the medical device is at least 0.5 μg / cm per day. 231. The medical device of any one of claims 14-30, having a maximum ion release of a major component of the rhenium-chromium metal alloy when inserted or implanted on or within a patient's body, wherein the major component comprises at least 2% by weight of the rhenium-chromium metal alloy.

[0203] (Appendix 33) 14. The medical device of claim 13, wherein the rhenium-chromium metal alloy on the medical device has an absolute increase in ion release per dose of rhenium-chromium metal alloy in tissue surrounding the medical device within 50 days after the rhenium-chromium metal alloy is inserted or implanted on or into a patient's body.

[0204] (Appendix 34) 33. The medical device of any one of claims 14-32, wherein the rhenium-chromium metal alloy on the medical device has an absolute increase in ion release per dose of rhenium-chromium metal alloy in tissue surrounding the medical device within 50 days after the rhenium-chromium metal alloy is inserted or implanted on or into a patient's body.

[0205] (Appendix 35) 14. The medical device of claim 13, wherein the medical device is an expandable stent or an expandable prosthetic heart valve.

[0206] (Appendix 36) 35. The medical device of any one of claims 14 to 34, wherein the medical device is an expandable stent or an expandable prosthetic heart valve.

[0207] (Appendix 37) A rhenium-based alloy comprising 0.5-60 atomic weight percent (atw.%) Re and 0.5-70 awt.% chromium, and one or more of molybdenum, tantalum, niobium, titanium, and zirconium, the combined atomic weight percentage of rhenium and chromium being at least 60 awt.%.

[0208] (Appendix 38) 38. The rhenium metal alloy of claim 37, wherein the rhenium-based alloy contains 10-50 atw.% Re and 5-60 atw.% Cr.

[0209] (Appendix 39) 38. The rhenium metal alloy of claim 37, wherein the rhenium metal alloy has a body-centered cubic (BCC) crystal structure.

[0210] (Appendix 40) 39. The rhenium metal alloy of claim 38, wherein the rhenium metal alloy has a body-centered cubic (BCC) crystal structure.

[0211] (Appendix 41) 1. A method for forming a rod, tube, green part, near net part, medical device, or the like, formed at least in part from a rhenium-chromium metal alloy by a forming process selected from the group consisting of a sintering process, a cold isostatic pressing (CIP) process, and a hot isostatic pressing (HIP) process, wherein metal particles used in the forming process have an average particle size of less than about 150 microns, the metal particles have a purity of at least 99%, the rhenium-chromium metal alloy comprises a rhenium-chromium metal alloy comprising rhenium and chromium, the method comprising the steps of: A) forming a rod, tube, green part, near net part, medical device, or the like, formed at least in part from a rhenium-chromium metal alloy by a forming process selected from the group consisting of a sintering process, a cold isostatic pressing (CIP) process, and a hot isostatic pressing (HIP) process ... A) the weight percent of rhenium in the rhenium-chromium metal alloy is greater than the weight percent of chromium in the rhenium-chromium metal alloy and the alloying agent comprises one or more metals selected from the group consisting of molybdenum, bismuth, niobium, tantalum, titanium, vanadium, tungsten, manganese, zirconium, technetium, ruthenium, rhodium, hafnium, osmium, copper, yttrium, zirconium, and iridium; or B) the weight percent of rhenium in the rhenium-chromium metal alloy is less than 50 weight percent and the rhenium-chromium metal alloy comprises 0.1 to 50 weight percent alloying agent. wherein the alloying agent comprises one or more metals selected from the group consisting of molybdenum, bismuth, niobium, tantalum, titanium, vanadium, tungsten, manganese, zirconium, technetium, ruthenium, rhodium, hafnium, osmium, copper, yttrium, zirconium, and iridium, the weight percentage of the chromium in the rhenium-chromium metal alloy is at least 25 weight percent, and the combined weight percentage of the rhenium and the chromium is at least 50 weight percent of the rhenium-chromium metal alloy.

[0212] (Appendix 42) 42. The method of claim 41, wherein the forming process includes a sintering process, and the sintering process is conducted at a temperature of at least 1600° C.

[0213] (Appendix 43) 42. The method of claim 41, wherein the sintering process is carried out a) in a non-oxidizing environment, b) under vacuum or under a pressure greater than 1 atmosphere, and / or c) for about 2 to 40 hours.

[0214] (Appendix 44) 43. The method of claim 42, wherein the sintering process is carried out a) in a non-oxidizing environment, b) under vacuum or under a pressure greater than 1 atmosphere, and / or c) for about 2 to 40 hours.

[0215] (Appendix 45) 42. The method of claim 41, wherein the forming process comprises a hot isostatic pressing (HIP) process, the hot isostatic pressing (HIP) process being conducted a) at a temperature of at least 1700°C, b) in a non-oxidizing environment, and / or c) under vacuum or a pressure greater than 1 atmosphere.

Claims

1. A rhenium-chromium metal alloy comprising rhenium and chromium, wherein A) the weight percentage of the rhenium in the rhenium-chromium metal alloy is at least 50 weight percent, the weight percentage of the chromium in the rhenium-chromium metal alloy is at least 25 weight percent, the weight percentage of an alloying agent in the rhenium-chromium metal alloy is 0-25 weight percent, the combined weight percentage of the rhenium and the chromium is at least 75 weight percent of the rhenium-chromium metal alloy, the weight percentage of the rhenium in the rhenium-chromium metal alloy is greater than the weight percentage of the chromium in the rhenium-chromium metal alloy, and the alloying agent is selected from the group consisting of molybdenum, bismuth, niobium, tantalum, titanium, vanadium, tungsten, manganese, zirconium, technetium, ruthenium, rhodium, hafnium, osmium, copper, or B) a weight percent of the rhenium in the rhenium-chromium metal alloy is less than 50 weight percent, the rhenium-chromium metal alloy comprising 0.1-50 weight percent alloying agent, the alloying agent comprising one or more metals selected from the group consisting of molybdenum, bismuth, niobium, tantalum, titanium, vanadium, tungsten, manganese, zirconium, technetium, ruthenium, rhodium, hafnium, osmium, copper, yttrium, zirconium, and iridium, the weight percent of the chromium in the rhenium-chromium metal alloy is at least 25 weight percent, and the combined weight percentage of the rhenium and the chromium is at least 50 weight percent of the rhenium-chromium metal alloy.

2. 2. The rhenium-chromium metal alloy of claim 1, wherein said weight percent of rhenium in said rhenium-chromium metal alloy is at least 60 weight percent and said weight percent of chromium in said rhenium-chromium metal alloy is at least 30 weight percent.

3. 2. The rhenium-chromium metal alloy of claim 1, wherein said weight percent of rhenium in said rhenium-chromium metal alloy is at least 64 weight percent and said weight percent of chromium in said rhenium-chromium metal alloy is at least 32.5 weight percent.

4. 3. The rhenium-chromium metal alloy of claim 2, wherein said weight percent of rhenium in said rhenium-chromium metal alloy is at least 64 weight percent and said weight percent of chromium in said rhenium-chromium metal alloy is at least 32.5 weight percent.

5. 2. The rhenium-chromium metal alloy of claim 1, wherein the alloying agent comprises 0.1-25 weight percent of the rhenium-chromium metal alloy, the alloying agent comprising one or more metals selected from the group consisting of molybdenum, bismuth, niobium, tantalum, titanium, vanadium, tungsten, manganese, zirconium, technetium, ruthenium, rhodium, hafnium, osmium, copper, yttrium, zirconium, and iridium.

6. 5. The rhenium-chromium metal alloy of any one of claims 2 to 4, wherein the alloying agent comprises 0.1 to 25 weight percent of the rhenium-chromium metal alloy, the alloying agent comprising one or more metals selected from the group consisting of molybdenum, bismuth, niobium, tantalum, titanium, vanadium, tungsten, manganese, zirconium, technetium, ruthenium, rhodium, hafnium, osmium, copper, yttrium, zirconium, and iridium.

7. The rhenium-chromium metal alloy of claim 5, wherein said alloying agent comprises 0.1 to 5 weight percent of said rhenium-chromium metal alloy.

8. The rhenium-chromium metal alloy of claim 6, wherein said alloying agent comprises 0.1 to 5 weight percent of said rhenium-chromium metal alloy.

9. The rhenium-chromium metal alloy of claim 1, wherein the rhenium-chromium metal alloy contains 0 to 0.1 weight percent impurities.

10. A rhenium-chromium metal alloy according to any one of claims 2 to 8, wherein the rhenium-chromium metal alloy contains 0 to 0.1 wt. % impurities.

11. 2. The rhenium-chromium metal alloy of claim 1, wherein the rhenium-chromium metal alloy has controlled amounts of nitrogen, oxygen, and carbon to reduce microcracking in the rhenium-chromium metal alloy, the nitrogen content in the rhenium-chromium metal alloy is less than the combined oxygen and carbon content in the rhenium-chromium metal alloy, the rhenium-chromium metal alloy has an oxygen to nitrogen atomic ratio of at least about 1.2:1, and the rhenium-chromium metal alloy has a carbon to nitrogen atomic ratio of at least about 2:

1.

12. 11. The rhenium-chromium metal alloy of any one of claims 2 to 10, wherein the rhenium-chromium metal alloy has controlled amounts of nitrogen, oxygen, and carbon to reduce microcracking in the rhenium-chromium metal alloy, the nitrogen content in the rhenium-chromium metal alloy is less than the combined oxygen and carbon content in the rhenium-chromium metal alloy, the rhenium-chromium metal alloy has an oxygen to nitrogen atomic ratio of at least about 1.2:1, and the rhenium-chromium metal alloy has a carbon to nitrogen atomic ratio of at least about 2:

1.

13. 10. A medical device formed at least in part from the rhenium-chromium metal alloy of claim 1.

14. A medical device formed at least in part from the rhenium-chromium metal alloy of any one of claims 2 to 12.

15. The medical device of claim 13 , wherein at least one region of the medical device comprises at least one biological agent.

16. The medical device of claim 14 , wherein at least one region of the medical device comprises at least one biological agent.

17. The medical device of claim 13 , wherein at least one region of the medical device comprises at least one polymer.

18. The medical device of any one of claims 14 to 17, wherein at least one region of the medical device comprises at least one polymer.

19. 16. The medical device of claim 15, wherein at least one region of the medical device comprises at least one polymer, and the at least one polymer at least partially coats, encapsulates, or a combination thereof, the at least one biological agent.

20. 19. The medical device of any one of claims 16-18, wherein at least one region of the medical device comprises at least one polymer, and the at least one polymer at least partially coats, encapsulates, or a combination thereof, the at least one biological agent.

21. The medical device of claim 13 , further comprising at least one microstructure on an exterior surface of the medical device.

22. The medical device of any one of claims 14 to 20, further comprising at least one microstructure on an exterior surface of the medical device.

23. 22. The medical device of claim 21, wherein the at least one microstructure is at least partially formed from, includes, or is a material consisting of a polymer, a drug, or a combination thereof.

24. 23. The medical device of claim 22, wherein the at least one microstructure is at least partially formed from, includes, or is a material consisting of a polymer, a drug, or a combination thereof.

25. 14. The medical device of claim 13, wherein the medical device comprises an expandable frame formed at least in part from the rhenium-chromium metal alloy, the expandable frame comprising a plurality of struts, and the expandable frame configured to be crimped to the crimped state such that a maximum outer diameter of the expandable frame when in the crimped state is less than a maximum outer diameter of the expandable frame when fully expanded to an expanded state.

26. 25. The medical device of any one of claims 14-24, wherein the medical device comprises an expandable frame formed at least in part from the rhenium-chromium metal alloy, the expandable frame comprising a plurality of struts, and the expandable frame configured to be crimped to the crimped state such that a maximum outer diameter of the expandable frame when in the crimped state is less than a maximum outer diameter of the expandable frame when fully expanded to an expanded state.

27. 26. The medical device of claim 25, wherein the expandable frame has a) less than 5% recoil after undergoing a first crimping process, and / or b) less than 5% recoil after being expanded from the crimped state to the expanded state.

28. 27. The medical device of claim 26, wherein the expandable frame has a) less than 5% recoil after undergoing a first crimping process, and / or b) less than 5% recoil after being expanded from the crimped state to the expanded state.

29. 14. The medical device of claim 13, wherein the rhenium-chromium metal alloy on the medical device is hydrophilic, and the contact angle of a water droplet on a surface of the rhenium-chromium metal alloy is between 25 and 45 degrees.

30. 29. The medical device of any one of claims 14 to 28, wherein the rhenium-chromium metal alloy on the medical device is hydrophilic, and the contact angle of a water droplet on a surface of the rhenium-chromium metal alloy is 25 to 45 degrees.

31. The rhenium-chromium metal alloy on the medical device is at least 0.5 μg / cm per day. ２ 14. The medical device of claim 13, having a maximum ion release of a major component of the rhenium-chromium metal alloy when inserted or implanted on or within a patient's body, said major component comprising at least 2% by weight of the rhenium-chromium metal alloy.

32. The rhenium-chromium metal alloy on the medical device is at least 0.5 μg / cm per day. ２ 31. The medical device of any one of claims 14-30, having a maximum ion release of a major component of the rhenium-chromium metal alloy when inserted or implanted on or within a patient's body, said major component comprising at least 2% by weight of the rhenium-chromium metal alloy.

33. 14. The medical device of claim 13, wherein the rhenium-chromium metal alloy on the medical device has an absolute increase in ion release per dose of rhenium-chromium metal alloy in tissue surrounding the medical device within 50 days after the rhenium-chromium metal alloy is inserted or implanted on or in a patient's body.

34. 33. The medical device of any one of claims 14-32, wherein the rhenium-chromium metal alloy on the medical device has an absolute increase in ion release per dose of rhenium-chromium metal alloy in tissue surrounding the medical device within 50 days after the rhenium-chromium metal alloy is inserted or implanted on or in a patient's body.

35. The medical device of claim 13 , wherein the medical device is an expandable stent or an expandable prosthetic heart valve.

36. The medical device of any one of claims 14 to 34, wherein the medical device is an expandable stent or an expandable prosthetic heart valve.

37. A rhenium-based alloy comprising 0.5-60 atomic weight percent (atw.%) Re and 0.5-70 awt.% chromium, and one or more of molybdenum, tantalum, niobium, titanium, and zirconium, the combined atomic weight percentage of rhenium and chromium being at least 60 awt.%.

38. 38. The rhenium metal alloy of claim 37, wherein the rhenium-based alloy comprises 10-50 atw.% Re and 5-60 atw.% Cr.

39. 38. The rhenium metal alloy of claim 37, wherein the crystal structure of the rhenium metal alloy is body-centered cubic (BCC).

40. 39. The rhenium metal alloy of claim 38, wherein the crystal structure of the rhenium metal alloy is body-centered cubic (BCC).

41. 1. A method for forming a rod, tube, green part, near net part, medical device, or the like, formed at least in part from a rhenium-chromium metal alloy by a forming process selected from the group consisting of a sintering process, a cold isostatic pressing (CIP) process, and a hot isostatic pressing (HIP) process, wherein metal particles used in the forming process have an average particle size of less than about 150 microns, the metal particles have a purity of at least 99%, and the rhenium-chromium metal alloy comprises a rhenium-chromium metal alloy comprising rhenium and chromium, the method comprising the steps of: A) forming a rod, tube, green part, near net part, medical device, or the like, formed at least in part from a rhenium-chromium metal alloy by a forming process selected from the group consisting of a sintering process, a cold isostatic pressing (CIP) process, and a hot isostatic pressing (HIP) process ... %. wherein the alloying agent comprises one or more metals selected from the group consisting of molybdenum, bismuth, niobium, tantalum, titanium, vanadium, tungsten, manganese, zirconium, technetium, ruthenium, rhodium, hafnium, osmium, copper, yttrium, zirconium, and iridium, the weight percentage of the chromium in the rhenium-chromium metal alloy is at least 25 weight percent, and the combined weight percentage of the rhenium and the chromium is at least 50 weight percent of the rhenium-chromium metal alloy.

42. 42. The method of claim 41, wherein the forming process includes the sintering process, and wherein the sintering process is carried out at a temperature of at least 1600°C.

43. 42. The method of claim 41, wherein the sintering process is carried out a) in a non-oxidizing environment, b) under vacuum or under pressure greater than 1 atmosphere, and / or c) for about 2 to 40 hours.

44. 43. The method of claim 42, wherein the sintering process is carried out a) in a non-oxidizing environment, b) under vacuum or under pressure greater than 1 atmosphere, and / or c) for about 2 to 40 hours.

45. 42. The method of claim 41 , wherein the forming process comprises the hot isostatic pressing (HIP) process, the hot isostatic pressing (HIP) process being carried out a) at a temperature of at least 1700° C., b) in a non-oxidizing environment, and / or c) under vacuum or under a pressure greater than 1 atmosphere.

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