Metal rod device, method of forming a metal rod device, method for forming a series of metal rods that can be used in a surgical procedure

Abstract

A medical device including a special heat treatment component, and a method for heat treating a metal alloy for a medical device.

Description

Technical Field

[0001] This disclosure is a continuation of part of U.S. Patent Application No. 18 / 116,677, filed on March 2, 2023, which in turn claims the priority of U.S. Provisional Application No. 63 / 316,077, filed on March 3, 2022. U.S. Patent Application No. 18 / 116,677 is incorporated herein by reference.

[0002] This disclosure is a continuation of part of U.S. Patent Application No. 17 / 876,282, filed on July 28, 2022, which in turn claims the priority of U.S. Provisional Application No. 63 / 247,540, filed on September 23, 2021. U.S. Patent Application No. 17 / 876,282 is incorporated herein by reference.

[0003] This disclosure claims the priority of U.S. Provisional Application No. 63 / 389,267, filed on July 14, 2022, which is incorporated herein by reference.

[0004] This disclosure generally relates to the heat treatment of metals, and more specifically to the heat treatment of refractory metal alloys or metal alloys containing at least 15 atomic weight percent (awt.%) rhenium, and even more specifically to the heat treatment of refractory metal alloys or metal alloys containing at least 15 awt.% rhenium. The heat treatment of refractory metal alloys or metal alloys containing at least 15 awt.% rhenium should be used in part or in whole for medical devices. Even more specifically, it relates to the heat treatment of refractory metal alloys or metal alloys containing at least 15 awt.% rhenium to produce variable yield strength and / or ultimate tensile strength along the longitudinal length of the metal alloy. The heat treatment of refractory metal alloys or metal alloys containing at least 15 awt.% rhenium should be used in part or in whole for medical devices.

Background Art

[0005] Stainless steel, cobalt-chromium alloys, and TiAlV alloys are part of the more common metal alloys used in medical devices. These alloys have been successful in forming various medical devices, but these alloys have some defects.

[0006] Refractory metal alloys and metal alloys containing at least 15 wt.% rhenium have been found to overcome many of these defects. Refractory metal alloys and metal alloys containing at least 15 wt.% rhenium can be harder and stronger than other metal alloys. In some applications, such as medical applications for spinal surgery, medical devices such as spinal rods formed from metal alloys need to have a certain degree of flexibility or bendability. To increase the flexibility or bendability of a metal alloy rod, the rod is generally ground to reduce the cross-sectional area of the rod, thereby making the rod more flexible. Accordingly, rods of different sizes are provided to the surgeon during a spinal procedure. However, the problem with using rods of different diameters is that different screws are generally required for different sized rods, which can complicate the surgery by having to keep track of the rods used in the medical procedure and can potentially lead to using the wrong screw during the procedure. SUMMARY OF THE INVENTION MEANS FOR SOLVING THE PROBLEM

[0007] The present disclosure generally relates to the heat treatment of metals, and more specifically, to the heat treatment of refractory metal alloys or metal alloys containing at least 15 atomic weight percent (awt.%) of rhenium, and even more specifically, to the heat treatment of refractory metal alloys or metal alloys containing at least 15 awt.% of rhenium, the heat treatment of refractory metal alloys or metal alloys containing at least 15 awt.% of rhenium should be used partially or fully for medical devices, and even more specifically, relates to the heat treatment of refractory metal alloys or metal alloys containing at least 15 awt.% of rhenium to produce variable yield strength and / or ultimate tensile strength along the longitudinal length of the metal alloy, the heat treatment of refractory metal alloys or metal alloys containing at least 15 awt.% of rhenium should be used partially or fully for medical devices. As defined herein, a refractory metal alloy is a metal alloy containing at least 20 weight% of one or more of molybdenum, rhenium, niobium, tantalum, or tungsten. Non-limiting refractory metal alloys include MoRe alloys, ReW alloys, MoReCr alloys, MoReTa alloys, MoReTi alloys, WCu alloys, ReCr, molybdenum alloys, rhenium alloys, tungsten alloys, tantalum alloys, niobium alloys, and the like.

[0008] According to one non-limiting aspect of the present disclosure, medical devices include orthopedic devices, PFO (patent foramen ovale) devices, stents, valves (e.g., heart valves, TAVR valves, mitral valve replacement, tricuspid valve replacement, pulmonary valve replacement, etc.), spinal implants, spinal discs, frames and other structures used with spinal implants, vascular implants, grafts, guidewires, sheaths, catheters, needles, stent catheters, electrophysiology catheters, hypodermic tubes, staples, cutting devices, implants of any type, pacemakers, dental implants, crowns, dental braces, wires used in medical procedures, bone implants, artificial discs, artificial spinal discs, bone (e.g., acromion, atlas, axis, calcaneus, carpus, clavicle, coccyx, maxilla, medial epicondyle, femur, fibula, frontal bone, greater trochanter, humerus, ilium, ischium, mandible, maxilla, metacarpus, metatarsus, occipital bone, olecranon, parietal bone, patella, phalanges, radius, rib, sacrum, scapula, sternum, talus, thigh, temporal bone, tibia, ulna, zygomatic bone, etc.) and / or cartilage repair, replacement, and / or support for prosthetic implants or devices, bone plates, knee replacement, hip replacement, shoulder replacement, ankle replacement, nails, rods, screws, struts, cages, plates, pedicle screws, caps, hinges, joint systems, anchors, spacers, shafts, anchors, discs, balls, tension bands, and, without limitation, lock connectors and other structural assemblies used in the body to support, attach, and / or repair structures within the body such as the human body, animal body, etc., but not limited to these.

[0009] According to one non-limiting aspect of the present disclosure, the metal alloy used to partially or fully form a medical device includes standard stainless steel, standard CoCr alloy, standard TiAlV alloy, standard aluminum alloy, standard nickel alloy, standard titanium alloy, standard tungsten alloy, standard molybdenum alloy, standard copper alloy, standard MP35N alloy, standard beryllium-copper alloy, refractory metal alloy, or metal alloy containing at least 15 atomic weight percent (awt.%) of rhenium. As defined herein, a standard stainless steel alloy contains 10-28 wt.% chromium, 0-35 wt.% nickel, 0-4 wt.% molybdenum, 0-2 wt.% manganese, 0-0.75 wt.% silicon, 0-0.3 wt.% carbon, 0-5 wt.% titanium, 0-10 wt.% niobium, 0-5 wt.% copper, 0-4 wt.% aluminum, 0-10 wt.% tantalum, 0-1 wt.% selenium (Se), 0-2 wt.% vanadium, 0-2 wt.% tungsten, and at least 5 wt.% iron. The standard 316L alloy contains 17-19 wt.% chromium, 13-15 wt.% nickel, 2-4 wt.% molybdenum, up to 2 wt.% manganese, up to 0.75 wt.% silicon, up to 0.03 wt.% carbon, and the balance iron. As defined herein, a standard CoCr alloy contains 15-32 wt.% chromium, 1-36 wt.% nickel, 2-18 wt.% molybdenum, 0-18 wt.% iron, 0-1 wt.% titanium, 0-0.15 wt.% manganese, 0-0.15 wt.% silver, 0-0.025 wt.% carbon, 0-16 wt.% tungsten, 0-2 wt.% %Si, 0-2 wt.% aluminum, 0-1 wt.% iron, and 30-68 wt.% cobalt. As defined herein, a standard MP35N alloy contains 19-21 wt.% chromium, 34-36 wt.% nickel, 9-11 wt.% molybdenum, up to 1 wt.% iron, up to 1 wt.% titanium, up to 0.15 wt.% manganese, up to 0.15 wt.% silver, up to 0.025 wt.% carbon, and the balance cobalt. As defined herein, standard Phynox and standard Elgiloy alloys contain 38-42 wt.% cobalt, 18-22 wt.% chromium, 14-18 wt.% iron, 13-17 wt.% nickel, and 6-8 wt.% molybdenum.As defined herein, the standard L605 alloy contains 18 - 22 wt% chromium, 14 - 16 wt% tungsten, 9 - 11 wt% nickel, and the balance cobalt. As defined herein, the standard TiAlV alloy contains 5.5 - 6.75 wt% aluminum, 3.5 - 4.5 wt% vanadium, 85 - 93 wt% titanium, 0 - 0.4 wt% iron, and 0 - 0.2 wt% carbon. The standard Ti - 6Al - 4V alloy contains 3.5 - 4.5 wt% vanadium, 5.5 - 6.75 wt% aluminum, up to 0.3 wt% iron, up to 0.2 wt% oxygen, up to 0.08 wt% carbon, up to 0.05 wt% nitrogen, up to 0.015 wt% hydrogen H, up to 0.05 wt% yttrium, and the balance titanium. As defined herein, the standard aluminum alloy contains 80 - 99 wt% aluminum, 0 - 12 wt% silicon, 0 - 5 wt% magnesium, 0 - 1 wt% manganese, 0 - 0.5 wt% scandium, 0 - 0.5 wt% beryllium, 0 - 0.5 wt% yttrium, 0 - 0.5 wt% cerium, 0 - 0.5 wt% chromium, 0 - 3 wt% iron, 0 - 0.5, 0 - 9 wt% zinc, 0 - 0.5 wt% titanium, 0 - 3 wt% lithium, 0 - 0.5 wt% silver, 0 - 0.5 wt% calcium, 0 - 0.5 wt% zirconium, 0 - 1 wt% lead, 0 - 0.5 wt% cadmium, 0 - 0.05 wt% bismuth, 0 - 1 wt% nickel, 0 - 0.2 wt% vanadium, 0 - 0.1 wt% gallium, and 0 - 7 wt% copper. As defined herein, the standard nickel alloy contains 30 - 98 wt% nickel, 5 - 25 wt% chromium, 0 - 65 wt% iron, 0 - 30 wt% molybdenum, 0 - 32 wt% copper, 0 - 32 wt% cobalt, 2 - 2 wt% aluminum, 0 - 6 wt% tantalum, 0 - 15 wt% tungsten, 0 - 5 wt% titanium, 0 - 6 wt% niobium, and 0 - 3 wt% silicon.As defined herein, a standard titanium alloy contains 80 - 99 wt% titanium, 0 - 6 wt% aluminum, 0 - 3 wt% tin, 0 - 1 wt% palladium, 0 - 8 wt% vanadium, 0 - 15 wt% molybdenum, 0 - 1 wt% nickel, 0 - 0.3 wt% ruthenium, 0 - 6 wt% chromium, 0 - 4 wt% zirconium, 0 - 4 wt% niobium, 0 - 1 wt% silicon, 0 - 0.5 wt% cobalt, and 0 - 2 wt% iron. As defined herein, a standard tungsten alloy contains 85 - 98 wt% tungsten, 0 - 8 wt% nickel, 0 - 5 wt% copper, 0 - 5 wt% molybdenum, and 0 - 4 wt% iron. As defined herein, a standard molybdenum alloy contains 90 - 99.5 wt% molybdenum, 0 - 1 wt% nickel, 0 - 1 wt% titanium, 0 - 1 wt% zirconium, 0 - 30 wt% tungsten, 0 - 2 wt% hafnium, and 0 - 2 wt% lanthanum. As defined herein, a standard copper alloy contains 55 - 95 wt% copper, 0 - 40 wt% zinc, 0 - 10 wt% tin, 0 - 10 wt% lead, 0 - 1 wt% iron, 0 - 5 wt% silicon, 0 - 12 wt% manganese, 0 - 12 wt% aluminum, 0 - 3 wt% beryllium, 0 - 1 wt% cobalt, and 0 - 20 wt% nickel. As defined herein, a standard MP35N alloy contains 32 - 38 wt% nickel, 18 - 22 wt% chromium, 8 - 12 wt% molybdenum, 0 - 2 wt% iron, 0 - 0.5 wt% silicon, 0 - 0.5 wt% manganese, 0 - 0.2 wt% carbon, 0 - 2 wt% titanium, 0 - 0.1 wt% phosphorus, 0 - 0.1 wt% boron, 0 - 0.1 wt% sulfur, and the balance cobalt. As defined herein, a standard beryllium - copper alloy contains 95 - 98.5 wt% copper, 1 - 4 wt% beryllium, 0 - 1 wt% cobalt, and 0 - 0.5 wt% silicon. As defined herein, a refractory metal alloy is a metal alloy containing at least 20 wt% of one or more of molybdenum, rhenium, niobium, tantalum, or tungsten.Examples of non-limiting refractory metal alloys include MoRe alloys, ReW alloys, MoReCr alloys, MoReTa alloys, MoReTi alloys, WCu alloys, ReCr, molybdenum alloys, rhenium alloys, tungsten alloys, tantalum alloys, niobium alloys, and the like.

[0010] According to another and / or alternative aspect of the present disclosure, the metallic alloy comprises at least 15 wt% rhenium and at least 0.1 wt% (e.g., 0.1 wt% to 96 wt%, and all values and ranges therebetween) of one or more of the metals aluminum, bismuth, chromium, cobalt, copper, hafnium, iridium, iron, magnesium, manganese, molybdenum, nickel, niobium, osmium, rhodium, ruthenium, silicon, silver, tantalum, technetium, titanium, tungsten, vanadium, yttrium, zirconium, and any such metallic alloy exhibits the rhenium effect. As defined herein, the "rhenium effect" is a) an increase in ductility of at least 10% of the metallic alloy caused by the addition of rhenium to the metallic alloy, and / or b) an increase in tensile strength of at least 10% of the metallic alloy caused by the addition of rhenium to the metallic alloy. For many metallic alloys (e.g., standard stainless steels, standard CoCr alloys, standard TiAlV alloys, standard aluminum alloys, standard nickel alloys, standard titanium alloys, standard tungsten alloys, standard molybdenum alloys, standard copper alloys, standard MP35N alloys, standard beryllium-copper alloys, etc.), it has been found that improved ductility and / or tensile strength result. When rhenium is added to a metallic alloy, a twining alloy can be formed in the metallic alloy, and as a result of reduction and / or work hardening of the metallic alloy including the addition of rhenium, as the yield and tensile strength increase, it has been found that the overall ductility of the metallic alloy increases. The rhenium effect occurs when the atomic weight of rhenium in the metallic alloy is at least 15% (e.g., 15 to 99 awt.% rhenium in the metallic alloy and all values and ranges therebetween). For example, in the case of a standard stainless steel alloy, the rhenium effect can begin to appear when the stainless steel alloy is modified to include an amount of rhenium of at least 5 to 10 wt% of the stainless steel alloy (and all values and ranges therebetween). In the case of a standard CoCr alloy, the rhenium effect can begin to appear when the CoCr alloy is modified to include an amount of rhenium of at least 4.8 to 9.5 wt% of the CoCr alloy (and all values and ranges therebetween).In the case of a standard TiAlV alloy, the rhenium effect can begin to appear when the TiAlV alloy is modified to contain a rhenium amount of at least 4.5 to 9 wt% of the TiAlV alloy (as well as all values and ranges therebetween). As can be understood, the rhenium content in the above example may be more than the minimum amount required to produce the rhenium effect in the metal alloy.

[0011] According to another and / or alternative aspect of the present disclosure, the metal alloy contains at least 15 wt% of rhenium and at least 0.1 wt% (e.g., 0.1 wt% to 96 wt%, as well as all values and ranges therebetween) of one or more of aluminum, bismuth, chromium, cobalt, copper, hafnium, iridium, iron, magnesium, manganese, molybdenum, nickel, niobium, osmium, rhodium, ruthenium, silicon, silver, tantalum, technetium, titanium, tungsten, vanadium, yttrium, zirconium, and all metal alloys exhibit the rhenium effect.

[0012] According to another and / or alternative aspect of the present disclosure, the metal alloy is a refractory metal alloy or a metal alloy containing an amount of rhenium sufficient to produce the rhenium effect in the metal alloy, and the metal alloy is a refractory metal alloy.

[0013] According to another and / or alternative aspect of the present disclosure, the metal alloy is a stainless steel alloy or a metal alloy containing an amount of rhenium sufficient to produce the rhenium effect in the metal alloy, and the metal alloy is a standard stainless steel alloy modified to contain at least 15 awt.% of rhenium.

[0014] According to another and / or alternative aspect of the present disclosure, the metal alloy is a standard cobalt-chromium alloy or a metal alloy containing an amount of rhenium sufficient to produce the rhenium effect in the metal alloy, and the metal alloy is a standard cobalt-chromium alloy modified to contain at least 15 awt.% of rhenium.

[0015] According to another and / or alternative aspect of the present disclosure, the metallic alloy is a standard TiAlV alloy or metallic alloy containing an amount of rhenium sufficient to produce the rhenium effect in the metallic alloy, and the metallic alloy is a standard TiAlV alloy modified to contain at least 15 wt.% rhenium.

[0016] According to another and / or alternative aspect of the present disclosure, the metallic alloy is a standard aluminum alloy or metallic alloy containing an amount of rhenium sufficient to produce the rhenium effect in the metallic alloy, and the metallic alloy is a standard aluminum alloy modified to contain at least 15 wt.% rhenium.

[0017] According to another and / or alternative aspect of the present disclosure, the metallic alloy is a standard nickel alloy or metallic alloy containing an amount of rhenium sufficient to produce the rhenium effect in the metallic alloy, and the metallic alloy is a standard nickel alloy modified to contain at least 15 wt.% rhenium.

[0018] According to another and / or alternative aspect of the present disclosure, the metallic alloy is a standard titanium alloy or metallic alloy containing an amount of rhenium sufficient to produce the rhenium effect in the metallic alloy, and the metallic alloy is a standard titanium alloy modified to contain at least 15 wt.% rhenium.

[0019] According to another and / or alternative aspect of the present disclosure, the metallic alloy is a standard tungsten alloy or metallic alloy containing an amount of rhenium sufficient to produce the rhenium effect in the metallic alloy, and the metallic alloy is a standard tungsten alloy modified to contain at least 15 wt.% rhenium.

[0020] According to another and / or alternative aspect of the present disclosure, the metallic alloy is a standard molybdenum alloy or metallic alloy containing an amount of rhenium sufficient to produce the rhenium effect in the metallic alloy, and the metallic alloy is a standard molybdenum alloy modified to contain at least 15 wt.% rhenium.

[0021] According to another and / or alternative aspect of the present disclosure, the metal alloy is a standard copper alloy or a metal alloy containing a sufficient amount of rhenium to produce the rhenium effect in the metal alloy, and the metal alloy is a standard copper alloy modified to contain at least 15 wt.% rhenium.

[0022] According to another and / or alternative aspect of the present disclosure, the metal alloy is a standard MP35N alloy or a metal alloy containing a sufficient amount of rhenium to produce the rhenium effect in the metal alloy, and the metal alloy is a standard MP35N alloy modified to contain at least 15 wt.% rhenium.

[0023] According to another and / or alternative aspect of the present disclosure, the metal alloy is a standard beryllium-copper alloy or a metal alloy containing a sufficient amount of rhenium to produce the rhenium effect in the metal alloy, and the metal alloy is a standard beryllium-copper alloy modified to contain at least 15 wt.% rhenium.

[0024] Some non-limiting examples of metal alloys that can be used to partially or fully form the frame of a medical device are shown below in weight percent. [Table 1] [Table 2] [Table 3] [Table 4] [Table 5] [Table 6] [Table 7] [Table 8]

Table 9

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Table 30

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Table 35

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Table 37

Table 38

Table 39

Table 40

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Table 42

Table 43

Table 44

Table 45

Table 46

Table 47

Table 48

Table 49

Table 50

Table 51

Table 52

Table 53

Table 54

Table 55

Table 56

Table 57

Table 58

[0025] In Examples 1 to 210, it will be understood that all of the above ranges include any value between the above ranges and any other range between the above ranges and the ranges described above. Any of the above values including the symbol ≦ includes the range from 0 to the stated value, as well as all values and ranges therebetween.

[0026] According to another and / or alternative non-limiting aspect of the present disclosure, a metal alloy used to partially or fully form a medical device includes an amount of rhenium sufficient to produce a "rhenium effect" in the metal alloy. As defined herein, the "rhenium effect" is a) an increase in ductility of at least 10% of the metal alloy caused by the addition of rhenium to the metal alloy, and / or b) an increase in tensile strength of at least 10% of the metal alloy caused by the addition of rhenium to the metal alloy. For many metal alloys, it has been found to result in improved ductility and / or tensile strength. When rhenium is added to a metal alloy, a twisted alloy can be formed in the metal alloy, and as a result of reduction and / or work hardening of the metal alloy including the addition of rhenium, as the yield and tensile strength increase, it has been found that the overall ductility of the metal alloy increases. The "rhenium effect" occurs when the atomic weight of rhenium in the metal alloy is at least 15% (e.g., 15 wt.% to 99 wt.% rhenium in the metal alloy and all values and ranges therebetween). For example, in the case of a standard stainless-steel alloy, the "rhenium effect" may begin to appear when the stainless-steel alloy is modified to include an amount of rhenium of at least 5 to 10 weight percent of the stainless-steel alloy (as well as all values and ranges therebetween). In the case of a standard CoCr alloy, the "rhenium effect" may begin to appear when the CoCr alloy is modified to include an amount of rhenium of at least 4.8 to 9.5 weight percent of the CoCr alloy (as well as all values and ranges therebetween). In the case of a standard TiAlV alloy, the "rhenium effect" may begin to appear when the TiAlV alloy is modified to include an amount of rhenium of at least 4.5 to 9 weight percent of the TiAlV alloy (as well as all values and ranges therebetween). As can be understood, the rhenium content in the above examples may be more than the minimum amount required to produce the "rhenium effect" in the metal alloy.

[0027] According to another and / or alternative non-limiting aspect of the present disclosure, the metal alloy used to partially or fully form a medical device comprises at least 15 wt.% rhenium (e.g., 15 - 99.9 wt.% and all values and ranges therebetween), and at least 0.1 wt.% (e.g., 0.1 wt.% - 96 wt.%, all values and ranges therebetween) of one or more additives selected from the group consisting of aluminum, bismuth, calcium, carbon, cerium oxide, chromium, cobalt, copper, gold, hafnium, iridium, iron, lanthanum, lanthanum oxide, lead, magnesium, manganese, molybdenum, nickel, niobium, osmium, platinum, rare earth metals, rhodium, ruthenium, silver, tantalum, technetium, titanium, tungsten, vanadium, yttrium, yttrium oxide, zinc, zirconium, and / or zirconium oxide. In another non-limiting embodiment, the metal alloy comprises at least 15 wt.% rhenium (e.g., 15 - 99.9 wt.% and all values and ranges therebetween), and at least 0.1 wt.% (e.g., 0.1 wt.% - 96 wt.%, all values and ranges therebetween) of two or more additives selected from the group consisting of aluminum, bismuth, calcium, carbon, cerium oxide, chromium, cobalt, copper, gold, hafnium, iridium, iron, lanthanum, lanthanum oxide, lead, magnesium, manganese, molybdenum, nickel, niobium, osmium, platinum, rare earth metals, rhodium, ruthenium, silver, tantalum, technetium, titanium, tungsten, vanadium, yttrium, yttrium oxide, zinc, zirconium, and / or zirconium oxide.In another non-limiting embodiment, the metal alloy comprises at least 15 wt.% rhenium (e.g., 15 - 99.9 wt.% and all values and ranges therebetween), and at least 0.1 wt.% (e.g., 0.1 wt.% - 96 wt.%, all values and ranges therebetween) of three or more additives selected from the group consisting of aluminum, bismuth, calcium, carbon, cerium oxide, chromium, cobalt, copper, gold, hafnium, iridium, iron, lanthanum, lanthanum oxide, lead, magnesium, manganese, molybdenum, nickel, niobium, osmium, platinum, rare earth metals, rhodium, ruthenium, silver, tantalum, technetium, titanium, tungsten, vanadium, yttrium, yttrium oxide, zinc, zirconium, and / or zirconium oxide.

[0028] According to another and / or alternative non-limiting aspect of the present disclosure, the metal alloy used to partially or fully form a medical device comprises at least 30 wt.% (e.g., 30 - 100 wt.% and all values and ranges therebetween) of a metal alloy, wherein the metal alloy comprises one or more of molybdenum, niobium, rhenium, tantalum, or tungsten. In another non-limiting embodiment, at least 40 wt.% of the metal alloy comprises one or more of molybdenum, niobium, rhenium, tantalum, or tungsten. In another non-limiting embodiment, at least 50 wt.% of the metal alloy comprises one or more of molybdenum, niobium, rhenium, tantalum, or tungsten.

[0029] In another non-limiting embodiment, the metal alloy used to partially or fully form the medical device comprises at least 50 wt% (e.g., 50 - 100 wt% and all values and ranges therebetween) of the metal alloy, the metal alloy comprising one or more of molybdenum, niobium, rhenium, tantalum, titanium, zirconium, or tungsten, 0 - 40 wt% (and all values and ranges therebetween) of the metal alloy comprising one or more additives selected from the group of aluminum, bismuth, calcium, carbon, cerium oxide, chromium, cobalt, copper, gold, hafnium, iridium, iron, lanthanum, lanthanum oxide, lead, magnesium, manganese, nickel, osmium, platinum, rare earth metals, rhodium, ruthenium, silver, technetium, vanadium, yttrium, yttrium oxide, zinc, and / or zirconium oxide, and the metal alloy comprising 0 - 2 wt% (and all values and ranges therebetween) of a combination of other metals, carbon, oxygen, phosphorus, sulfur, hydrogen, and nitrogen.

[0030] According to another and / or alternative non-limiting aspect of the present disclosure, the metal alloy used to partially or fully form a medical device comprises at least 20 wt% (e.g., 20 - 99 wt% and all values and ranges therebetween) of a metal alloy, and the metal alloy contains rhenium. In one non-limiting embodiment, the metal alloy comprises at least 20 wt% (e.g., 20 - 99.9 wt% and all values and ranges therebetween) of rhenium, and 0.1 - 80 wt% (and all values and ranges therebetween) of one or more additives selected from the group consisting of aluminum, bismuth, calcium, carbon, cerium oxide, chromium, cobalt, copper, gold, hafnium, iridium, iron, lanthanum, lanthanum oxide, lead, magnesium, manganese, molybdenum, nickel, niobium, osmium, platinum, rare earth metals, rhodium, ruthenium, silver, tantalum, technetium, titanium, tungsten, vanadium, yttrium, yttrium oxide, zinc, zirconium, and / or zirconium oxide, and the metal alloy contains 0 - 2 wt% (and all values and ranges therebetween) of a combination of other metals, carbon, oxygen, phosphorus, sulfur, hydrogen, and nitrogen. In another non-limiting embodiment, 35 - 60 wt% (e.g., and all values and ranges therebetween) of the metal alloy contains rhenium, and 40 - 65 wt% (and all values and ranges therebetween) of the metal alloy contains two or more of molybdenum, niobium, tantalum, titanium, vanadium, chromium, manganese, zirconium, technetium, ruthenium, rhodium, hafnium, osmium, copper, and / or iridium. In another non-limiting embodiment, 35 - 60 wt% of the metal alloy contains rhenium, and 40 - 65 wt% of the metal alloy contains three or more of molybdenum, niobium, tantalum, titanium, vanadium, chromium, manganese, zirconium, technetium, ruthenium, rhodium, hafnium, osmium, copper, and / or iridium. In another non-limiting embodiment, the weight percentage of molybdenum in the metal alloy is at least 10 wt% and less than 60 wt% (and all values and ranges therebetween).In another non-limiting embodiment, the weight percent of rhenium in the metal alloy is 35 to 60 weight percent (and all values and ranges therebetween). In another non-limiting embodiment, the combined weight percent of the alloying metals is 5 to 45 weight percent of the metal alloy (and all values and ranges therebetween). In another non-limiting embodiment, the weight percent of rhenium in the metal alloy is greater than the combined weight percent of the alloying metals. In another non-limiting embodiment, the combined weight % of rhenium, molybdenum, and one or more alloying metals in the metal alloy is at least 99.9 weight percent. According to another and / or alternative non-limiting aspect of the present disclosure, the atomic weight percent of rhenium relative to the combined atomic weight percent of bismuth, niobium, tantalum, tungsten, titanium, vanadium, chromium, manganese, yttrium, zirconium, technetium, ruthenium, rhodium, hafnium, osmium, copper, and iridium in the metal alloy is 0.7:1 to 1.5:1 (and all values and ranges therebetween), typically 0.8:1 to 1.4:1, more typically 0.8:1 to 1.25:1, and even more typically about 0.9:1 to 1.1:1 (e.g., 1:1). In one particular non-limiting formulation, the atomic weight percent of rhenium relative to the combined atomic weight percent of bismuth, chromium, iridium, niobium, tantalum, titanium, yttrium, and zirconium is 0.7:1 to 5.1:1 (and all values and ranges therebetween), typically 0.8:1 to 1.5:1, more typically 0.8:1 to 1.25:1, and even more typically about 0.9:1 to 1.1:1 (e.g., 1:1). In one particular non-limiting formulation, the atomic weight percent of rhenium relative to the combined atomic weight percent of chromium, niobium, tantalum, and zirconium is 0.7:1 to 5.1:1 (and all values and ranges therebetween), typically 0.8:1 to 1.5:1, more typically 0.8:1 to 1.25:1, and even more typically about 0.9:1 to 1.1:1 (e.g., 1:1).According to another non-limiting embodiment, when the metal alloy contains two of bismuth, niobium, tantalum, tungsten, titanium, vanadium, chromium, manganese, yttrium, zirconium, technetium, ruthenium, rhodium, hafnium, osmium, copper, and iridium, the atomic ratio of the two metals is 0.4:1 to 2.5:1 (as well as all values and ranges therebetween), typically 0.5:1 to 2:1.

[0031] In another non-limiting aspect of the present disclosure, the metal alloy used to partially or fully form a medical device comprises rhenium and tungsten, and optionally, one or more alloying agents such as, but not limited to, aluminum, bismuth, calcium, carbon, cerium oxide, chromium, cobalt, copper, gold, hafnium, iridium, iron, lanthanum, lanthanum oxide, lead, magnesium, manganese, molybdenum, nickel, niobium, osmium, platinum, rare earth metals, rhodium, ruthenium, silver, tantalum, technetium, titanium, vanadium, yttrium, yttrium oxide, zinc, zirconium, and / or zirconium oxide, and / or one or more alloys of such components (e.g., WRe, WReMo, etc.), and the metal alloy comprises a combination of other metals, carbon, oxygen, phosphorus, sulfur, hydrogen, and nitrogen in an amount of 0 to 2 wt% (and all values and ranges therebetween). In one non-limiting formulation, the metal alloy comprises up to 40 wt% rhenium and at least 60 wt% tungsten. In one non-limiting embodiment, the total weight percent of tungsten and rhenium in the tungsten-rhenium alloy is at least about 95 wt%, typically at least about 99 wt%, more typically at least about 99.5 wt%, still more typically at least about 99.9 wt%, and even more typically at least about 99.99 wt%. In another non-limiting formulation, the metal alloy comprises up to 47.5 wt% rhenium and at least 20 - 80 wt% tungsten (and all values and ranges therebetween) and 1 - 47.5 wt% molybdenum (and all values and ranges therebetween). In another non-limiting specific tungsten-rhenium-molybdenum alloy, the weight percent of tungsten is greater than 50 wt% of the tungsten-rhenium-molybdenum alloy. In another non-limiting specific tungsten-rhenium-molybdenum alloy, the weight percent of tungsten is greater than the weight percent of rhenium but less than the weight percent of molybdenum. In another non-limiting specific tungsten-rhenium-molybdenum alloy, the weight percent of tungsten is greater than the weight percent of molybdenum but less than the weight percent of rhenium.In another non-limiting specific tungsten-rhenium-molybdenum alloy, the weight percentage of tungsten is less than the weight percentage of rhenium and also less than the weight percentage of molybdenum.

[0032] According to another and / or alternative non-limiting aspect of the present disclosure, a metal alloy used to partially or fully form a medical device with at least 35 wt% (e.g., 35 - 75 wt% and all values and ranges therebetween) of rhenium, and the metal alloy also contains chromium. In one non-limiting embodiment, at least 25 wt% (e.g., 25 - 49.9 wt% and all values and ranges therebetween) of the metal alloy contains chromium. In another non-limiting embodiment, at least 30 wt% of the metal alloy contains chromium. In another non-limiting embodiment, at least 33 wt% of the metal alloy contains chromium. In another non-limiting embodiment, at least 50 wt% (e.g., 50 - 74.9 wt% and all values and ranges therebetween) of the metal alloy contains rhenium, at least 25 wt% (e.g., 25 - 49.9 wt% and all values and ranges therebetween) of the metal alloy contains chromium, and 0.1 - 25 wt% (and all values and ranges therebetween) of the metal alloy contains one or more of aluminum, bismuth, calcium, carbon, cerium oxide, cobalt, copper, gold, hafnium, iridium, iron, lanthanum, lanthanum oxide, lead, magnesium, manganese, molybdenum, nickel, niobium, osmium, platinum, rare earth metals, rhodium, ruthenium, silver, tantalum, technetium, titanium, tungsten, vanadium, yttrium, yttrium oxide, zinc, zirconium, and / or zirconium oxide. In another non-limiting embodiment, at least 55 wt% (e.g., 55 - 69.9 wt% and all values and ranges therebetween) of the metal alloy contains rhenium, at least 30 wt% (e.g., 30 - 44.9 wt% and all values and ranges therebetween) of the metal alloy contains chromium, and 0.1 - 15 wt% (and all values and ranges therebetween) of the metal alloy contains one or more of molybdenum, bismuth, niobium, tantalum, titanium, vanadium, tungsten, manganese, zirconium, technetium, ruthenium, rhodium, hafnium, osmium, copper, yttrium, zirconium, and / or iridium. In another non-limiting embodiment, the alloy metal contains chromium.In another non-limiting embodiment, the alloying metal comprises chromium and one or more metals selected from the group consisting of bismuth, zirconium, iridium, niobium, tantalum, titanium, and yttrium. In another non-limiting embodiment, the alloying metal comprises chromium and one or more metals selected from the group consisting of bismuth, zirconium, iridium, niobium, tantalum, titanium, and yttrium, and the atomic ratio of chromium to each or all of the metals selected from the group consisting of bismuth, chromium, iridium, niobium, tantalum, titanium, and yttrium is 0.4:1 to 2.5:1 (and all values and ranges therebetween). In another non-limiting embodiment, the alloying metal comprises chromium and one or more metals selected from the group consisting of zirconium, niobium, and tantalum. In another non-limiting embodiment, the alloying metal comprises a first metal selected from the group consisting of bismuth, chromium, iridium, niobium, tantalum, titanium, yttrium, and zirconium, and a second metal selected from the group consisting of bismuth, chromium, iridium, niobium, tantalum, titanium, yttrium, and zirconium, the first metal and the second metal are different, and the atomic ratio of the first metal to the second metal is 0.4:1 to 2.5:1 (and all values and ranges therebetween). In another non-limiting embodiment, the alloying metal is a first metal selected from the group consisting of chromium, niobium, tantalum, and zirconium, and a second metal selected from the group consisting of chromium, niobium, tantalum, and zirconium, the first metal and the second metal are different, and the atomic ratio of the first metal to the second metal is 0.4:1 to 2.5:1 (and all values and ranges therebetween).

[0033] According to another and / or alternative non-limiting aspect of the present disclosure, the metal alloy used to partially or completely form a medical device comprises 10 to 60 atomic weight percent (awt.%) of Re (and all values and ranges therebetween), and one or more metals selected from the group consisting of Mo, Cr, Ta, Nb, Ti, and Zr. In one non-limiting embodiment, the metal alloy comprises 15 to 60 awt.% of Re, and one or more metals selected from the group consisting of Cr, Ta, Nb, Ti, and Zr. In another non-limiting embodiment, the metal alloy comprises 15 to 60 awt.% of Re, and one or more metals selected from the group consisting of 0.5 to 70 awt.% of Cr (and all values and ranges therebetween), 0.5 to 70 awt.% of Ta (and all values and ranges therebetween), 0.5 to 70 awt.% of Nb (and all values and ranges therebetween), 0.5 to 70 awt.% of Ti (and all values and ranges therebetween), and 0.5 to 70 awt.% of Zr (and all values and ranges therebetween).

[0034] According to another and / or alternative non-limiting aspect of the present disclosure, the metal alloy used to partially or completely form a medical device comprises 0.5 to 50 awt.% of Re (and all values and ranges therebetween), and 0.5 to 70 awt.% of Cr (and all values and ranges therebetween).

[0035] According to another and / or alternative non-limiting aspect of the present disclosure, the metal alloy used to partially or completely form a medical device comprises 0.5 to 50 awt.% of Re (and all values and ranges therebetween), and 0.5 to 70 awt.% of Ta (and all values and ranges therebetween).

[0036] According to another and / or alternative non-limiting aspect of the present disclosure, the metal alloy used to partially or completely form a medical device comprises 0.5 to 50 awt.% of Re (and all values and ranges therebetween), and 0.5 to 70 awt.% of Nb (and all values and ranges therebetween).

[0037] According to another and / or alternative non-limiting aspect of the present disclosure, the metal alloy used to partially or fully form a medical device comprises 0.5 to 50 wt.% Re (and all values and ranges therebetween), and 0.5 to 70 wt.% Ti (and all values and ranges therebetween).

[0038] According to another and / or alternative non-limiting aspect of the present disclosure, the metal alloy used to partially or fully form a medical device comprises greater than 50 wt.% titanium (e.g., 51 to 80 wt.% and all values and ranges therebetween), 15 to 45 wt.% (and all values and ranges therebetween) niobium, 1 to 10 wt.% (and all values and ranges therebetween) zirconium, and 1 to 15 wt.% (and all values and ranges therebetween) tantalum. In one non-limiting formulation, the metal alloy comprises 58 to 70 wt.% titanium, 27 to 37 wt.% niobium, and 2 to 9 wt.% zirconium, and 1 to 15 wt.% tantalum.

[0039] According to another and / or alternative non-limiting aspect of the present disclosure, the metal alloy used to partially or fully form a medical device comprises greater than 50 wt.% titanium (e.g., 51 to 80 wt.% and all values and ranges therebetween), 15 to 45 wt.% (and all values and ranges therebetween) niobium, and 1 to 10 wt.% (and all values and ranges therebetween) molybdenum. In one non-limiting formulation, the metal alloy comprises 58 to 69 wt.% titanium, 27 to 33 wt.% niobium, and 4 to 8 wt.% molybdenum.

[0040] According to another and / or alternative non-limiting aspect of the present disclosure, the metal alloy used to partially or completely form a medical device comprises 30 to 60 wt% cobalt (and all values and ranges therebetween), 10 to 30 wt% chromium (and all values and ranges therebetween), 5 to 20 wt% iron (and all values and ranges therebetween), 5 to 22 wt% nickel (and all values and ranges therebetween), and 2 to 12 wt% molybdenum (and all values and ranges therebetween). In one non-limiting formulation, the metal alloy comprises 35 to 45 wt% cobalt, 15 to 25 wt% chromium, 12 to 20 wt% iron, 10 to 20 wt% nickel, and 5 to 9 wt% molybdenum.

[0041] According to another and / or alternative non-limiting aspect of the present disclosure, the metal alloy used to partially or completely form a medical device comprises 40 to 60 wt% zirconium (and all values and ranges therebetween), and 40 to 60 wt% molybdenum (and all values and ranges therebetween). In one non-limiting formulation, the metal alloy comprises 45 to 55 wt% cobalt, and 45 to 55 wt% molybdenum.

[0042] According to another and / or alternative non-limiting aspect of the present disclosure, the metal alloy used to partially or completely form a medical device comprises 90 to 99.5 wt% niobium (and all values and ranges therebetween), and 0.5 to 10 wt% zirconium (and all values and ranges therebetween). In one non-limiting formulation, the metal alloy comprises 95 to 99.25 wt% niobium, and 0.75 to 4 wt% niobium.

[0043] According to another and / or alternative non-limiting aspect of the present disclosure, the metal alloy used to partially or completely form a medical device comprises 55 to 75 wt% niobium (and all values and ranges therebetween), 18 to 40 wt% tantalum (and all values and ranges therebetween), 1 to 7 wt% tungsten (and all values and ranges therebetween), and 0.5 to 4 wt% zirconium (and all values and ranges therebetween). In one non-limiting formulation, the metal alloy comprises 60 to 70 wt% niobium, 24 to 32 wt% tantalum, 2 to 5 wt% tungsten, and 0.75 to 3 wt% zirconium.

[0044] In another and / or alternative non-limiting aspect of the present disclosure, the metal alloy used to partially or completely form a medical device comprises, in addition to rhenium, at least two metals selected from the group consisting of molybdenum, bismuth, niobium, tantalum, tungsten, titanium, vanadium, chromium, manganese, yttrium, zirconium, technetium, ruthenium, rhodium, hafnium, osmium, copper, and iridium, and the content of other elements and compounds in the metal alloy is 0 to 0.1 wt%, typically 0 to 0.01 wt%, more typically 0 to 0.001 wt%. In another specific non-limiting formulation, the metal alloy is formed from at least two metals selected from the group consisting of molybdenum, bismuth, chromium, iridium, niobium, tantalum, titanium, yttrium, and zirconium, in addition to rhenium, and the content of other elements and compounds in the metal alloy is 0 to 0.1 wt%, typically 0 to 0.01 wt%, more typically 0 to 0.001 wt%. In another specific non-limiting formulation, the metal alloy is formed from at least three metals selected from the group consisting of rhenium, molybdenum, chromium, niobium, tantalum, and zirconium, in addition to rhenium, and the content of other elements and compounds in the metal alloy is 0 to 0.1 wt%, typically 0 to 0.01 wt%, more typically 0 to 0.001 wt%.

[0045] According to another and / or alternative non-limiting aspect of the present disclosure, the metal alloy comprises 10 to 60 atomic weight percent (awt.%) of Re (and all values and ranges therebetween), and one or more metals selected from the group consisting of Mo, Cr, Ta, Nb, Ti, and Zr. In one non-limiting embodiment, the metal alloy comprises 15 to 60 awt.% of Re, and one or more metals selected from the group consisting of Cr, Ta, Nb, Ti, and Zr. In another non-limiting embodiment, the metal alloy comprises 15 to 60 awt.% of Re, and one or more metals selected from the group consisting of 0.5 to 70 awt.% of Cr (and all values and ranges therebetween), 0.5 to 70 awt.% of Ta (and all values and ranges therebetween), 0.5 to 70 awt.% of Nb (and all values and ranges therebetween), 0.5 to 70 awt.% of Ti (and all values and ranges therebetween), and 0.5 to 70 awt.% of Zr (and all values and ranges therebetween).

[0046] According to another and / or alternative non-limiting aspect of the present disclosure, the metal alloy comprises 0.5 to 50 awt.% of Re (and all values and ranges therebetween), and 0.5 to 70 awt.% of Cr (and all values and ranges therebetween).

[0047] According to another and / or alternative non-limiting aspect of the present disclosure, the metal alloy comprises 0.5 to 50 awt.% of Re (and all values and ranges therebetween), and 0.5 to 70 awt.% of Ta (and all values and ranges therebetween).

[0048] According to another and / or alternative non-limiting aspect of the present disclosure, the metal alloy comprises 0.5 to 50 awt.% of Re (and all values and ranges therebetween), and 0.5 to 70 awt.% of Nb (and all values and ranges therebetween).

[0049] According to another and / or alternative non-limiting aspect of the present disclosure, the metal alloy comprises 0.5 to 50 wt.% Re (and all values and ranges therebetween), and 0.5 to 70 wt.% Ti (and all values and ranges therebetween).

[0050] According to another and / or alternative non-limiting aspect of the present disclosure, the metal alloy comprises greater than 50 wt.% titanium (e.g., 51 to 80 wt.% and all values and ranges therebetween), 15 to 45 wt.% (and all values and ranges therebetween) niobium, 1 to 10 wt.% (and all values and ranges therebetween) zirconium, and 1 to 15 wt.% (and all values and ranges therebetween) tantalum. In one non-limiting formulation, the metal alloy comprises 58 to 70 wt.% titanium, 27 to 37 wt.% niobium, and 2 to 9 wt.% zirconium, and 1 to 15 wt.% tantalum.

[0051] According to another and / or alternative non-limiting aspect of the present disclosure, the metal alloy comprises greater than 50 wt.% titanium (e.g., 51 to 80 wt.% and all values and ranges therebetween), 15 to 45 wt.% (and all values and ranges therebetween) niobium, and 1 to 10 wt.% (and all values and ranges therebetween) molybdenum. In one non-limiting formulation, the metal alloy comprises 58 to 69 wt.% titanium, 27 to 33 wt.% niobium, and 4 to 8 wt.% molybdenum.

[0052] According to another and / or alternative non-limiting aspect of the present disclosure, the metal alloy comprises 30 to 60 wt.% cobalt (and all values and ranges therebetween), 10 to 30 wt.% chromium (and all values and ranges therebetween), 5 to 20 wt.% iron (and all values and ranges therebetween), 5 to 22 wt.% nickel (and all values and ranges therebetween), and 2 to 12 wt.% molybdenum (and all values and ranges therebetween). In one non-limiting formulation, the metal alloy comprises 35 to 45 wt.% cobalt, 15 to 25 wt.% chromium, 12 to 20 wt.% iron, 10 to 20 wt.% nickel, and 5 to 9 wt.% molybdenum.

[0053] According to another and / or alternative non-limiting aspect of the present disclosure, the metal alloy comprises 40 to 60 wt% zirconium (and all values and ranges therebetween), and 40 to 60 wt% molybdenum (and all values and ranges therebetween). In one non-limiting formulation, the metal alloy comprises 45 to 55 wt% cobalt, and 45 to 55 wt% molybdenum.

[0054] According to another and / or alternative non-limiting aspect of the present disclosure, the metal alloy comprises 90 to 99.5 wt% niobium (and all values and ranges therebetween), and 0.5 to 10 wt% zirconium (and all values and ranges therebetween). In one non-limiting formulation, the metal alloy comprises 95 to 99.25 wt% niobium, and 0.75 to 4 wt% niobium.

[0055] According to another and / or alternative non-limiting aspect of the present disclosure, the metal alloy comprises 55 to 75 wt% niobium (and all values and ranges therebetween), 18 to 40 wt% tantalum (and all values and ranges therebetween), 1 to 7 wt% tungsten (and all values and ranges therebetween), and 0.5 to 4 wt% zirconium (and all values and ranges therebetween). In one non-limiting formulation, the metal alloy comprises 60 to 70 wt% niobium, 24 to 32 wt% tantalum, 2 to 5 wt% tungsten, and 0.75 to 3 wt% zirconium.

[0056] In another and / or alternative non-limiting aspect of the present disclosure, the metal alloy used to partially or fully form a medical device comprises less than about 5 wt% (e.g., 0 to 4.999999 wt% and all values and ranges therebetween) of other metals and / or impurities, typically 0 to 1 wt%, more typically 0 to 0.1 wt%, even more typically 0 to 0.01 wt%, and even more typically 0 to 0.001 wt%. The high purity level of the metal alloy results in a more uniform alloy formation, which in turn results in a more uniform density throughout the metal alloy, as well as the desired yield and ultimate tensile strength of the metal alloy.

[0057] In another and / or alternative non-limiting aspect of the present disclosure, the metal alloy used to form the medical device, in whole or in part, contains a specific amount of carbon and oxygen, although this is not essential. These two elements have been found to affect the forming characteristics and brittleness of the metal alloy. A controlled atomic ratio of carbon and oxygen in the metal alloy can also be used to minimize the tendency of the metal alloy to form microcracks during the formation of the metal alloy and / or during the use and / or expansion of the medical device. The carbon-to-oxygen atomic ratio can be as low as about 0.2:1 (e.g., 0.2:1 to 50:1, and all values and ranges therebetween). Typically, the carbon content of the metal alloy is less than about 0.2 wt% (e.g., 0 wt% to 0.1999999 wt% and all values and ranges therebetween). If the carbon content is too high, it may adversely affect the physical properties of the metal alloy. Generally, the oxygen content should be maintained at a very low level. In one non-limiting formulation of the metal alloy, the oxygen content is less than about 0.1 wt% of the metal alloy (e.g., 0 wt to 0.0999999 wt% and all values and ranges therebetween). In another non-limiting embodiment, the metal alloy optionally contains a controlled amount of nitrogen, although this is not essential. A large amount of nitrogen in the metal alloy can adversely affect the ductility of the metal alloy. This can also adversely affect the elongation characteristics of the metal alloy. If the nitrogen content in the metal alloy is too high, the ductility of the metal alloy will begin to decrease unacceptably, and thus may adversely affect one or more physical properties of the metal alloy that are useful or desired for the formation and / or use of the medical device. In one non-limiting formulation, the metal alloy contains less than about 0.001 wt% nitrogen (e.g., 0 wt% to 0.0009999 wt% and all values and ranges therebetween). It is believed that the nitrogen content must be less than the carbon or oxygen content in the metal alloy. In one non-limiting formulation of the metal alloy, the carbon-to-nitrogen atomic ratio 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 of the metal alloy, the atomic ratio of oxygen to nitrogen is at least about 1.2:1 (e.g., 1.2:1 to 150:1 and all values and ranges therebetween).

[0058] According to another and / or alternative non-limiting aspect of the present disclosure, the metal alloy used to partially or fully form a medical device has: a) optionally, an average Vickers hardness of at least about 150 Vickers (e.g., 150 to 300 Vickers and all values and ranges therebetween); b) an average hardness greater than that of stainless steel (e.g., grade 304, grade 316); c) optionally, an average ultimate tensile strength of at least about 100 ksi (e.g., 100 to 350 ksi and all values and ranges therebetween); d) optionally, an average yield strength of at least about 80 ksi (e.g., 80 to 300 ksi and all values and ranges therebetween); e) an average grain size of about 4 ASTM or less (e.g., 4 ASTM to 20 ASTM and all values and ranges therebetween using ASTM E112, e.g., 0.35 micron to 90 microns and all values and ranges therebetween); e) optionally, an average tensile elongation of at least about 25% (e.g., 25% to 50% average tensile elongation and all values and ranges therebetween).

[0059] According to another and / or alternative non-limiting aspect of the present disclosure, a medical device is provided that is partially or fully formed from a refractory metal alloy. Non-limiting refractory metal alloys include MoRe alloys, ReW alloys, MoReCr alloys, MoReTa alloys, MoReTi alloys, WCu alloys, ReCr alloys, Mo alloys, Re alloys, W alloys, Ta alloys, Nb alloys, and the like. In one non-limiting embodiment, 50 to 100% (as well as all values and ranges therebetween) of the medical device is formed from a refractory metal alloy. In another non-limiting embodiment, 50 to 100% (as well as all values and ranges therebetween) of the medical device is formed from a MoRe alloy. In another non-limiting embodiment, at least 30 wt% (e.g., 30 to 100 wt% and all values and ranges therebetween) of the refractory metal alloy includes one or more of molybdenum, rhenium, niobium, tantalum, or tungsten.

[0060] According to another and / or alternative non-limiting aspect of the present disclosure, a refractory metal alloy or metal alloy containing at least 15 wt.% rhenium 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 or bendability, tensile strength, tensile elongation, longitudinal elongation, stress-strain characteristics, reduced reactivity, radiopacity, thermal sensitivity, biocompatibility, improved fatigue life, crack resistance, crack propagation resistance, reduced magnetic susceptibility, etc.), improved conformity when bent, less reactivity, 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 fusion, and / or reduced ion release into tissue. These one or more improved physical properties of the refractory metal alloy or metal alloy containing at least 15 wt.% rhenium can be achieved without increasing the volume, bulk, and / or weight of a medical device or a part of a medical device (e.g., the frame of a medical device, etc.). In some examples, these improved physical properties can be obtained even when the volume, bulk, and / or weight of a medical device or a part of a medical device (e.g., the frame of a medical device, etc.) is reduced compared to a medical device or the frame of a medical device formed at least in part from conventional stainless steel, titanium alloy, or cobalt and chromium alloy materials. Compared to an expandable frame formed from stainless steel, CoCr alloy, and TiAlV alloy, the reduced recoil, improved bend conformity, and greater radial strength of an expandable frame formed at least in part from a refractory metal alloy or metal alloy containing at least 15 wt.% rhenium provide one or more of the following non-limiting advantages.1) i) Safer vascular access when inserting a medical device through a body passage into a treatment area, and / or ii) formation of a frame for a medical device having thinner struts, struts, and / or strut joints that results in a reduction in the risk of bleeding and / or damage to the body passage and / or treatment area when the medical device is delivered to and / or expanded in the treatment area; 2) i) Reduction of trauma to the body passage (e.g., blood vessels, aortic arch trauma, etc.) during insertion and / or expansion of a medical device in the treatment area, and / or ii) easier deliverability of the medical device to the treatment area that can result in a reduction in the risk of neurological complications - stroke; 3) i) Reduction of the crimp profile size, ii) increased conformity of the expanded medical device in the treatment area after expansion in the treatment area, iii) increased radial strength of the frame of the medical device after expansion in the treatment area, iv) requiring only a single crimp cycle to crimp the medical device on a balloon catheter or other type of delivery device, v) reduction in the incidence of damage to the components of the medical device (e.g., struts, struts, strut joints, and / or other components of the expandable frame, leaflets, skirts, coatings, etc.) during crimping, expansion, and operation of the medical device, vi) increase in the effective orifice area (EOA) of the medical device after expansion of the medical device, vi) reduction of 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 a balloon catheter or other expansion mechanism to fully expand the medical device, resulting in less recoil, and / or 4) I) Improvement of tissue adhesion and / or growth on or around the medical device, II) reduction of harmful tissue reaction with the medical device, III) reduction of the toxicity of the medical device, IV) potential reduction of in-valve thrombosis during the life of the medical device, and / or V) creating a medical device having excellent material biocompatibility properties to reduce the incidence of infection during the life of the medical device.

[0061] According to another and / or alternative non-limiting aspect of the present disclosure, a refractory metal alloy or metal alloy containing at least 15 wt.% rhenium used to at least partially form a medical device or a part of a medical device (e.g., the frame of a medical device, etc.) thus: 1) increases the radiopacity of the medical device or a part of the medical device (e.g., the frame of a medical device, etc.); 2) increases the radial strength of the medical device or a part of the medical device (e.g., the frame of a medical device, etc.); 3) increases the yield strength and / or ultimate tensile strength of the medical device or a part of the medical device (e.g., the frame of a medical device, etc.); 4) improves the stress-strain characteristics of the medical device or a part of the medical device (e.g., the frame of a medical device, etc.); 5) improves the crimping and / or expansion characteristics of the medical device or a part of the medical device (e.g., the frame of a medical device, etc.); 6) improves the bendability and / or flexibility of the medical device or a part of the medical device (e.g., the frame of a medical device, etc.); 7) improves the strength and / or durability of the medical device or a part of the medical device (e.g., the frame of a medical device, etc.); 8) increases the hardness of the medical device or a part of the medical device (e.g., the frame of a medical device, etc.); 9) improves the recoil characteristics of the medical device or a part of the medical device (e.g., the frame of a medical device, etc.); 10) improves the biostability and / or biocompatibility characteristics of the medical device or a part of the medical device (e.g., the frame of a medical device, etc.); 11) increases the fatigue resistance of the medical device or a part of the medical device (e.g., the frame of a medical device, etc.); 12) resists crack initiation and crack propagation in the medical device or a part of the medical device (e.g., the frame of a medical device, etc.); 13) enables the production of a smaller, thinner, and / or lighter-weight medical device or a part of the medical device (e.g., the frame of a medical device, etc.); 14) reduces the outer diameter of a crimped medical device or a part of the medical device (e.g., the frame of a medical device, etc.); 15) when the medical device or a part of the medical device (e.g., the frame of a medical device, etc.) is used and / or expanded in the treatment area, the medical device or a part of the medical device (e.g.,improve the conformity of a medical device or a part of a medical device (e.g., the frame of a medical device, etc.) to the shape of the treatment area, 16) when the medical device or a part of the medical device (e.g., the frame of the medical device, etc.) is expanded within the treatment area, reduce the recoil momentum of the medical device or a part of the medical device (e.g., the frame of the medical device, etc.) with respect to the shape of the treatment area, 17) increase the yield strength of the medical device or a part of the medical device (e.g., the frame of the medical device, etc.), 18) improve the fatigue ductility of the medical device or a part of the medical device (e.g., the frame of the medical device, etc.), 18) improve the durability of the medical device or a part of the medical device (e.g., the frame of the medical device, etc.), 19) improve the fatigue life of the medical device or a part of the medical device (e.g., the frame of the medical device, etc.), 20) reduce the harmful tissue reaction after implantation of the medical device or a part of the medical device (e.g., the frame of the medical device, etc.), 21) reduce the metal ion release after implantation of the medical device or a part of the medical device (e.g., the frame of the medical device, etc.), 22) reduce the corrosion of the medical device or a part of the medical device (e.g., the frame of the medical device, etc.) after implantation of the medical device or a part of the medical device (e.g., the frame of the medical device, etc.), 23) reduce the allergic reaction after implantation of the medical device or a part of the medical device (e.g., the frame of the medical device, etc.), 24) improve the hydrophilicity of the medical device or a part of the medical device (e.g., the frame of the medical device, etc.), 25) reduce the thickness of the metal component of the medical device or a part of the medical device (e.g., the frame of the medical device, etc.), 26) improve the bone fusion with the medical device or a part of the medical device (e.g., the frame of the medical device, etc.), and / or 27) reduce the ion release from the medical device or a part of the medical device (e.g., the frame of the medical device, etc.) to the tissue, 28) when implanted in a patient, reduce the magnetic susceptibility of the medical device or a part of the medical device (e.g., the frame of the medical device, etc.), and / or 29) reduce the toxicity of the medical device or a part of the medical device (e.g., the frame of the medical device, etc.) after implantation of the artificial medical device.

[0062] According to another and / or alternative non-limiting aspect of the present disclosure, a medical device or a part of a medical device (e.g., a frame of a medical device, etc.) is optionally subjected to one or more manufacturing processes. These manufacturing processes include expansion, laser cutting, shaving, plug reaming, etching (such as chemical etching, plasma etching, etc.), curling, photoetching, coating, annealing, centerless grinding, rotation, reaming, pilgering, electroplating, polishing, electropolishing, machining, plasma coating, 3D printing, 3D printed coating, cold working, drilling (e.g., gun drilling, etc.), chemical vapor deposition, chemical polishing, cleaning, buffing, smoothing, pickling, ion beam deposition or implantation, sputter coating, vacuum deposition, swaging, nitriding, annealing, EDM cutting, microelectromechanical manufacturing (MEMS) technology [e.g., micromachining, laser micromachining, laser micromachining, micro molding, etc.], etc., but are not limited thereto. In one non-limiting embodiment, the medical device is optionally subjected to a swaging process. The swaging operation can be performed on the medical device in the area to be hardened. In one non-limiting configuration, the swaging temperature can be from room temperature (RT) (e.g., 10 to 27 °C, and all values and ranges therebetween) to about 400 °C (e.g., 10 to 400 °C, and all values and ranges therebetween) when swaging is performed in air or an oxidizing environment. When 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 a maximum of about 1500 °C (e.g., 10 to 1500 °C, and all values and ranges therebetween). During the swaging process, boron and / or nitrogen ions can optionally collide with rhenium atoms in a metal alloy containing rhenium to form ReB2, ReN2, and / or ReN3. In another non-limiting embodiment, the medical device is optionally subjected to nitriding (e.g., gas nitriding, salt bath nitriding, plasma nitriding, etc.). The thickness of the nitrided surface layer is less than about 1 mm.In one non-limiting embodiment, the thickness of the nitrided surface layer is at least about 50 nanometers and less than about 1 mm (as well as all values and ranges therebetween). Generally, the weight percent of nitrogen in the nitrided surface layer is from 0.0001 to 5 weight percent nitrogen (as well as all values and ranges therebetween). Generally, the weight percent of nitrogen in the nitrided surface layer is generally less than at least one, and generally all, of the primary components of the metal alloy (e.g., the primary component is an alloying component that is more than 5 weight percent of the metal alloy). The nitriding process for the metal alloy can be used to increase the surface hardness and / or wear resistance of the metal alloy, increase the smoothness or lubricity of the surface of the metal alloy, and / or inhibit or prevent discoloration of the metal alloy (e.g., discoloration due to oxidation). In another non-limiting embodiment, the metal alloy can optionally be nitrided before and / or after at least one drawing step and / or annealing step for the metal alloy.

[0063] According to another and / or alternative non-limiting aspect of the present disclosure, a refractory metal alloy or metal alloy comprising at least 15 wt.% rhenium used to at least partially form a medical device or a part of a medical device (e.g., a frame of a medical device) optionally has a generally uniform density throughout the refractory metal alloy or metal alloy comprising at least 15 wt.% rhenium and also provides the desired yield and ultimate tensile strength of the refractory metal alloy or metal alloy comprising at least 15 wt.% rhenium. The density of the refractory metal alloy or metal alloy comprising at least 15 wt.% rhenium is generally at least about 5 g / cc (e.g., 5 g / cc - 21 g / cc, as well as all values and ranges therebetween, such as 10 - 20 g / cc), and typically at least about 11 - 19 g / cc. This substantially uniform high density of the refractory metal alloy or metal alloy comprising at least 15 wt.% rhenium can optionally improve the radiopacity of the refractory metal alloy or metal alloy comprising at least 15 wt.% rhenium.

[0064] In another and / or alternative non-limiting aspect of the present disclosure, a refractory metal alloy or metal alloy comprising at least 15 wt.% rhenium used to form all or part of a medical device is 1) optionally not coated, metallized, plated, and / or formed (e.g., cold worked, hot worked, etc.) on another metal, or 2) optionally does not have another metal or metal alloy metallized, plated, coated, and / or formed on a refractory metal alloy or metal alloy comprising at least 15 wt.% rhenium.

[0065] In another and / or alternative non-limiting aspect of the present disclosure, a refractory metal alloy or metal alloy comprising at least 15 wt.% rhenium used to form all or part of a medical device is 1) coated, metallized, plated, and / or formed (e.g., cold worked, hot worked, etc.) on another metal, or 2) has another metal or metal alloy metallized, plated, coated, and / or formed on a refractory metal alloy or metal alloy comprising at least 15 wt.% rhenium.

[0066] According to another and / or alternative non-limiting aspect of the present disclosure, a medical device or a part of a medical device (e.g., a frame of a medical device, etc.) can optionally be at least partially or completely formed from a tube or rod of a refractory metal alloy or metal alloy comprising at least 15 wt.% rhenium, or can be formed into a shape that is at least 80% of the final net shape of the medical device or a part of the medical device (e.g., a frame of a medical device, etc.).

[0067] According to another and / or alternative non-limiting aspect of the present disclosure, a refractory metal alloy or metal alloy containing at least 15 wt.% rhenium has several physical properties that have a positive impact on a medical device when the medical device is at least partially formed from a refractory metal alloy or metal alloy containing at least 15 wt.% rhenium. In one non-limiting embodiment of the present disclosure, the average Vickers hardness of a refractory metal alloy or metal alloy containing at least 15 wt.% rhenium used to at least partially form a medical device or a part of a medical device (e.g., the frame of a medical device, etc.) is optionally at least about 150 Vickers (e.g., 150 - 300 Vickers, and all values and ranges therebetween), typically 160 - 240 Vickers, but this is not essential. A refractory metal alloy or metal alloy containing at least 15 wt.% rhenium generally has a greater average hardness than stainless steel (e.g., grade 304, grade 316). In another and / or alternative non-limiting embodiment of the present disclosure, the average ultimate tensile strength of a refractory metal alloy or metal alloy containing at least 15 wt.% rhenium is optionally at least about 100 ksi (e.g., 100 - 350 ksi, and all values and ranges therebetween), but this is not essential. In yet another and / or alternative non-limiting embodiment of the present disclosure, the average yield strength of a refractory metal alloy or metal alloy containing at least 15 wt.% rhenium is optionally at least about 80 ksi (e.g., 80 - 300 ksi, and all values and ranges therebetween), but this is not essential. In still another and / or alternative non-limiting embodiment of the present disclosure, the average particle size of a refractory metal alloy or metal alloy containing at least 15 wt.% rhenium used to at least partially form a medical device or a part of a medical device (e.g., the frame of a medical device, etc.) is optionally about 4 ASTM or less (e.g., 4 ASTM - 20 ASTM using ASTM E112, and all values and ranges therebetween, e.g., 0.35 microns - 90 microns, and all values and ranges therebetween).A small particle size of a refractory metal alloy or metal alloy containing at least 15 wt.% rhenium enables a medical device or a part of a medical device (e.g., a frame of a medical device) to have desired elongation and ductility properties useful for forming, crimping, and / or expanding the medical device or a part of the medical device (e.g., a frame of a medical device).

[0068] In another and / or alternative non-limiting embodiment of the present disclosure, the average tensile elongation of a refractory metal alloy or metal alloy containing at least 15 wt.% rhenium used to at least partially form a medical device or a part of a medical device (e.g., a frame of a medical device) is optionally at least about 25% (e.g., an average tensile elongation of 25% - 50% and all values and ranges therebetween). An average tensile elongation of at least 25% for a refractory metal alloy or metal alloy containing at least 15 wt.% rhenium is useful for facilitating proper expansion of a medical device or a part of a medical device (e.g., a frame of a medical device) when placed in a treatment area of a body passage. A medical device or a frame of a medical device partially or completely formed from a material having an average tensile elongation of less than about 25% is prone to developing microcracks and / or fractures during the formation, crimping, and / or expansion of the medical device or a part of the medical device (e.g., a frame of a medical device).

[0069] According to another and / or alternative non-limiting aspect of the present disclosure, the medical device can optionally include, contain, and / or be coated with one or more agents that facilitate the success of the medical device and / or the treatment area. The term "agent" includes, but is not limited to, substances, pharmaceuticals, biological products, veterinary products, drugs, and analogs or derivatives formulated and / or designed in other ways to prevent, inhibit, and / or treat one or more clinical and / or biological events and / or to promote healing. Non-limiting examples of clinical events that can be addressed by one or more agents include viruses, fungal and / or bacterial infections, vascular diseases and / or disorders, gastrointestinal diseases and / or disorders, reproductive diseases and / or disorders, lymphatic 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, neuropathic diseases and / or disorders, kidney diseases and / or disorders, ulcers, liver diseases and / or disorders, intestinal diseases and / or disorders, gallbladder diseases and / or disorders, pancreatic diseases and / or disorders, psychological disorders, respiratory diseases and / or disorders, glandular diseases and / or disorders, skin diseases and / or disorders, auditory diseases and / or disorders, oral diseases and / or disorders, nasal diseases and / or disorders, eye diseases and / or disorders, fatigue, genetic diseases and / or disorders, burns, scars and / or keloids, trauma, weight diseases and / or disorders, toxic diseases and / or disorders, hair loss, seizures, muscle spasms, tissue repair, nerve repair, nerve regeneration, and / or the like, but are not limited thereto. The type and / or amount of the agent included in and / or coated on the medical device can vary. When two or more agents are included in and / or coated on the medical device, the amounts of the two or more agents can be the same or different. The type and / or amount of the agent included on, in, and / or in combination with the medical device are generally selected to address one or more clinical events.When the agent is used, the amount of the agent included on, within, and / or used in combination with the medical device is about 0.01 to 100 μg per mm2 of the medical device (as well as all values and ranges therebetween) and / or at least about 0.00001% by weight, although other amounts can also be used. The amounts of two or more agents included on, within, and / or used in combination with the medical device can be the same or different. One or more agents can be coated and / or impregnated onto the medical device by various mechanisms including, but not limited to, spraying (e.g., nebulizing spray techniques, etc.), flame spray coating, powder deposition, dip coating, flow coating, dip spin coating, roll coating (direct and reverse), ultrasonic treatment, brushing, plasma deposition, deposition by vapor deposition, MEMS technology, and rotary deposition. When two or more agents are used, the amounts of two or more agents included on, within, and / or used in combination with the medical device can be the same or different. The medical device can be configured such that 1) all agents on and / or within the medical device are controllably released, 2) a portion of the agents on and / or within the medical device are controllably released and a portion of the agents on the medical device are uncontrollably 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 drugs from a medical device include: 1) at least partially coating one or more drugs with one or more polymers; 2) at least partially incorporating and / or at least partially encapsulating one or more drugs within one or more polymers and / or together with one or more polymers; and / or 3) inserting one or more drugs into pores, passages, cavities, etc. within the medical device and at least partially coating or covering such pores, passages, cavities, etc. with one or more polymers. As can be understood, other or additional configurations can be used to control the release of one or more drugs from the medical device. The thickness of each polymer layer and / or drug layer, when used, is generally at least about 0.01 μm and generally less than about 150 μm (e.g., 0.01 - 149.9999 μm and all values and ranges therebetween).

[0070] According to another and / or alternative non-limiting aspect of the present disclosure, the medical device can optionally include a marker material that facilitates the medical device being properly positioned in the treatment area. 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., ultrasonic waves, etc.), magnetic waves (e.g., MRI, etc.), and / or other types of electromagnetic waves (e.g., microwaves, visible light, infrared waves, ultraviolet waves, etc.). In one non-limiting embodiment, the marker material is visible to X-rays (i.e., radiopaque). The marker material can form all or part of the medical device and / or can coat one or more parts of the medical device. The location of the marker material can be at one or more locations on the medical device.

[0071] According to another and / or alternative non-limiting aspect of the present disclosure, the medical device is a device that can be expanded by using several other devices (e.g., a balloon, etc.).

[0072] According to another and / or alternative non-limiting aspect of the present disclosure, the medical device is manufactured from a material that does not have or substantially does not have shape memory properties.

[0073] According to another and / or alternative non-limiting aspect of the present disclosure, the net portions, blanks, rods, tubes, etc. used to partially or fully form the medical device are: 1) melting a metal alloy and / or the metals forming the metal alloy (e.g., by vacuum arc melting, etc.), and then extruding and / or casting the metal alloy into near-net portions, blanks, rods, tubes, etc.; 2) melting a metal alloy and / or the metals forming the metal alloy, forming a metal strip, and then rolling and welding the strip into near-net portions, blanks, rods, tubes, etc.; 3) adhering (such as pressing, pressing and sintering, etc.) the metal powder of the metal alloy and / or the metal powder of the metals forming the metal alloy onto near-net portions, blanks, rods, tubes, etc.; and / or 4) 3D printing the metal alloy onto near-net portions, blanks, rods, tubes, etc., and the like, and can be formed by various techniques, but are not limited thereto.

[0074] According to another and / or alternative non-limiting aspect of the present disclosure, optionally, a near-net process for a medical device is provided. In one non-limiting embodiment of the present disclosure, a method is provided for powder compressing a material and optionally increasing the strength after sintering by applying additional cold working. In one non-limiting embodiment, the raw part is pressurized and then sintered. Thereafter, the sintered part is pressurized again to increase its mechanical strength by applying cold working to the pressurized and sintered part. Generally, the temperature during the pressurization process after the sintering process is 20 to 100 °C (as well as all values and ranges therebetween), typically 20 to 80 °C, and more typically 20 to 40 °C. As defined herein, cold working is performed at a temperature of 150 °C or less (e.g., 10 to 150 °C, as well as all values and ranges therebetween). It is necessary to determine the change in the shape of the post-sintering part after repressurization so that the final part (pressurized, sintered, and repressurized) meets the dimensional requirements of the final formed part. Following a pre-press pressure of 1 to 300 tsi (tons per square inch) (as well as all values and ranges therebetween), a sintering process at at least 1600 °C (e.g., 1600 to 2600 °C as well as all values and ranges therebetween), and a post-sintering press at a pressure of 1 to 300 tsi (as well as all values and ranges therebetween) at a temperature of at least 20 °C (e.g., 20 to 100 °C as well as all values and ranges therebetween, 20 to 40 °C, etc.) can be used.

[0075] According to another and / or alternative non-limiting aspect of the present disclosure, optionally provided is a press for near-net or finished part composite materials for medical devices that includes the use of a degradable polymer. This process involves pressing a composite structure formed from metal powder and a polymer for the purpose of creating complex part shapes and structures such as foams. When the pressed part is sintered, the polymer is partially or completely removed through the thermal decomposition process of the polymer. The resulting part has porosity related to the size of the polymer particles and the homogeneity of the mixture during pressing prior to sintering. Generally, the polymer constitutes from about 0.1 to 70 volume % (and all values and ranges therebetween) of the adhered and pressed material prior to the sintering step.

[0076] According to another and / or alternative non-limiting aspect of the present disclosure, a medical device can optionally include one or more surface structures (e.g., pores, channels, holes, ribs, slots, cuts, protrusions, teeth, needles, depressions, holes, grooves, etc.). These structures can be at least partially formed by MEMS (e.g., microfabrication, etc.) techniques and / or other types of techniques (e.g., 3D printing, etc.). According to one non-limiting aspect, a medical device can optionally include one or more microstructures (e.g., micro needles, micro pores, micro cylinders, micro cones, micro pyramids, micro tubes, micro parallelepipeds, micro prisms, micro hemispheres, teeth, ribs, ridges, ratchets, hinges, zippers, structures such as binding bands, 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.) of about 2 mm or less, typically about 1 mm or less. As can be understood, if a medical device includes one or more surface structures, 1) all surface structures can be microstructures, 2) all surface structures can be non-microstructures, or 3) a portion of the surface structures can be microstructures and a portion can be non-microstructures. Non-limiting examples of structures that can be formed on a medical device are shown in U.S. Patent Publications Nos. 2004 / 0093076 and 2004 / 0093077, which are incorporated herein by reference. Typically, if formed, the microstructures extend from or within the outer surface by about 400 microns (0.01 - 400 microns, and all values and ranges therebetween), more typically less than about 300 microns, and more typically about 15 - 250 microns, although other sizes can be used. In another non-limiting embodiment, 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 channels that can contain one or more materials (e.g., drugs, polymers, etc.), although this is not essential.

[0077] According to another and / or alternative non-limiting aspect of the present disclosure, the medical device can optionally be an expandable device that can be expanded by the use of some other device (e.g., a balloon, etc.).

[0078] According to another and / or alternative non-limiting aspect of the present disclosure, the medical device can optionally be manufactured from a material that does not have or substantially does not have shape memory properties.

[0079] According to another and / or alternative non-limiting aspect of the present disclosure, optionally, a near-net process for a frame of a medical device and / or other metal components is provided. In one non-limiting embodiment of the present disclosure, a method of powder compressing a material and optionally increasing the strength after sintering by applying additional cold working is provided. In one non-limiting embodiment, the raw part is pressurized and then sintered. Thereafter, the sintered part is pressurized again to increase its mechanical strength by applying cold working to the pressurized and sintered part. Generally, the temperature during the pressurization process after the sintering process is 20 to 100 °C (as well as all values and ranges therebetween), typically 20 to 80 °C, and more typically 20 to 40 °C. As defined herein, cold working is performed at a temperature of 150 °C or lower (e.g., 10 to 150 °C, as well as all values and ranges therebetween). It is necessary to determine the shape change of the post-sintering part after repressurization so that the final part (pressurized, sintered, and repressurized) meets the dimensional requirements of the final formed part. In the case of Mo47.5Re alloy, MoRe alloy, ReW alloy, molybdenum alloy, tungsten alloy, rhenium alloy, other refractory metal alloys, or other metal alloys containing at least 15 wt.% rhenium, following a pre-press pressure of 1 to 300 tsi (1 ton per square inch) (as well as all values and ranges therebetween), a sintering process at at least 1600 °C (e.g., 1600 to 2600 °C, as well as all values and ranges therebetween), and a post-sintering press at a pressure of 1 to 300 tsi (as well as all values and ranges therebetween) at a temperature of at least 20 °C (e.g., 20 to 100 °C, as well as all values and ranges therebetween, such as 20 to 40 °C) can be used. An optional process is also provided to increase the mechanical strength of the pressurized metal part by repressurizing the post-sintering part to apply additional cold working to the material, thereby increasing its mechanical strength. An optional process of powder compressing to a near-net or final part using metal powder is also provided.In one non-limiting embodiment, the metal powder used to form the near-net or final part contains at least 40 wt% rhenium and at least 25 wt% molybdenum, and the balance may optionally contain one or more elements of tungsten, tantalum, chromium, niobium, zirconium, iridium, titanium, bismuth, and yttrium. In another non-limiting embodiment, the metal powder used to form the near-net or final part contains 20 - 80 wt% rhenium (and all values and ranges therebetween), 20 - 80 wt% molybdenum (and all values and ranges therebetween), and optionally one or more elements of tungsten, tantalum, chromium, niobium, zirconium, iridium, titanium, bismuth, and yttrium. In another non-limiting embodiment, the metal powder used to form the near-net or final part contains tungsten (20 - 60 wt% and all values and ranges therebetween), rhenium (20 - 80 wt% and all values and ranges therebetween), and 0 - 5 wt% of one or more other elements (and all values and ranges therebetween). In another non-limiting embodiment, the metal powder used to form the near-net or final part contains tungsten (20 - 80 wt% and all values and ranges therebetween), rhenium (20 - 80 wt% and all values and ranges therebetween), molybdenum (0.01 - 15 wt% and all values and ranges therebetween), and 0 - 5 wt% of one or more other elements (and all values and ranges therebetween). In another non-limiting embodiment, the metal powder used to form the near-net or final part contains tungsten (20 - 80 wt% and all values and ranges therebetween), copper (1 - 30 wt% and all values and ranges therebetween), and 0 - 5 wt% of one or more other elements (and all values and ranges therebetween). In another non-limiting embodiment, the metal powder used to form the near-net or final part contains 35 - 65 wt% rhenium (and all values and ranges therebetween), and two or more elements of tungsten, tantalum, molybdenum, chromium, niobium, zirconium, iridium, titanium, bismuth, and yttrium.In another non-limiting embodiment, the metal powder used to form the near-net or final part comprises 35 to 65 wt% rhenium (and all values and ranges therebetween), molybdenum powder, and 11 to 41 wt% (and all values and ranges therebetween) chromium powder, and optionally, a combination with the powder of one or more metals selected from the group consisting of bismuth, tungsten, tantalum, molybdenum, chromium, niobium, zirconium, iridium, niobium, tantalum, titanium, bismuth, and yttrium. In another non-limiting embodiment, the metal powder used to form the near-net or final part comprises 35 to 65 wt% rhenium (and all values and ranges therebetween), and chromium, and 0.1 to 25 wt% (and all values and ranges therebetween), and one or more elements of molybdenum, bismuth, niobium, tungsten, tantalum, titanium, vanadium, tungsten, manganese, zirconium, technetium, ruthenium, rhodium, hafnium, osmium, copper, iridium, and yttrium. In another non-limiting embodiment, the metal powder used to form the near-net or final part comprises 25 to 95 wt% rhenium (and all values and ranges therebetween), and calcium, carbon, chromium, cobalt, copper, gold, hafnium, iridium, iron, lanthanum, lanthanum oxide, lead, magnesium, manganese, molybdenum, nickel, niobium, osmium, platinum, rare earth metals, rhodium, ruthenium, silver, tantalum, technetium, titanium, tungsten, vanadium, yttrium, zinc, zirconium, and / or one or more alloys of one or more of such components.

[0080] According to another and / or alternative non-limiting aspect of the present disclosure, optionally, a press of a near-net or finished part composite is provided. The process of pressing metal into the near-net of a finished part is well established, but it is new to press a composite structure formed from metal powder and polymer for the purpose of creating complex part shapes and structures such as foams. Similarly, it is new to use a pressing process to impart certain biological substances to a metal matrix. In one non-limiting embodiment, a process is provided for creating a trabecular or foam structure that comprises creating a metal part with pre-defined voids, mixing metal and polymer powders, then pressing the powders into a finished part or semi-finished raw part, and then sintering the part through a thermal decomposition process of the polymer under conditions where the polymer leaves the metal behind. The resulting part has porosity related to the size of the polymer particles and the uniformity of the mixture during pressing prior to sintering. In another non-limiting embodiment, a process is provided where (on a metal substrate) a polymer residue remains after pyrolysis and the polymer residue has some desired biological effects (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 a plurality of voids, some large to create a pathway for cell growth and some small to create a rough surface to promote cell attachment.

[0081] According to another and / or alternative non-limiting aspect of the present disclosure, when a refractory metal alloy or metal alloy containing at least 15 wt.% rhenium is formed into a blank, the shape and size of the blank are non-limiting. When a refractory metal alloy or metal alloy containing at least 15 wt.% rhenium is formed into a rod or tube, the rod or tube generally has a length of about 48 inches or less (e.g., 0.1 to 48 inches and all values and ranges therebetween), but longer lengths can be formed. In one non-limiting configuration, the length of the rod or tube is about 8 to 20 inches. The average outer diameter of the rod or tube is generally less than about 2 inches (i.e., a cross-sectional area of less than about 3.14 square inches), more typically an outer diameter of less than about 1 inch, and even more typically an outer diameter of about 0.5 inches or less. However, larger rod or tube diameter sizes can also be formed. In one non-limiting configuration of the tube, the tube has an inner diameter of about 0.31 inches plus or minus about 0.002 inches and an outer diameter of about 0.5 inches plus or minus about 0.002 inches. The wall thickness of the tube is about 0.095 inches plus or minus about 0.002 inches. As can be understood, this is merely an example of many different sized tubes that can be formed. In one non-limiting process, near-net frames, blanks, rods, tubes, etc. of a medical device or part of a medical device (e.g., the frame of a medical device, etc.). In one non-limiting process, a near-net medical device or part of a medical device (e.g., the frame of a medical device, etc.), blank, rod, tube, etc. can be formed from one or more ingots of a metal or refractory metal alloy or metal alloy containing at least 15 wt.% rhenium. In one non-limiting process, an arc melting process (e.g., a vacuum arc melting process, etc.) can be used to form a near-net medical device or part of a medical device (e.g., the frame of a medical device, etc.), blank, rod, tube, etc.In another non-limiting process, rhenium powder, tungsten powder, and optionally molybdenum powder are 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 a near-net medical device or a part of a medical device (e.g., the frame of a medical device, etc.), a blank, a rod, a tube, etc. As can be understood, other metal particles can be used to form other refractory metal alloys or metal alloys containing at least 15 wt.% rhenium (e.g., molybdenum alloys, rhenium alloys, MoRe alloys, MoReCr alloys, FeCrMoCB alloys, WCu alloys, WRe alloys, ReCr alloys, MoReTa alloys, MoReTi alloys, ReCr alloys, W alloys, Ta alloys, Nb alloys, etc.) by various processes such as melting, sintering, particle compression, and heat. It can be understood that other or additional processes can be used to form a refractory metal alloy or metal alloy containing at least 15 wt.% rhenium. When a tube of a refractory metal alloy or metal alloy containing at least 15 wt.% rhenium is formed, a close-fitting rod can be used to form the tube during the extrusion process, but this is not essential. In another and / or additional non-limiting process, a tube of a refractory metal alloy or metal alloy containing at least 15 wt.% rhenium can be formed from a strip or sheet of a refractory metal alloy or metal alloy containing at least 15 wt.% rhenium. A strip or sheet of a refractory metal alloy or metal alloy containing at least 15 wt.% rhenium can be formed into a tube by rolling the ends of the sheet or strip and then welding the ends of the sheet or strip together.Welding the ends of a sheet or strip can be achieved in several ways, including but not limited to: a) holding the ends together and then electron beam welding the ends together in a vacuum; b) placing a thin strip of a refractory metal alloy or metal alloy containing at least 15 wt.% rhenium on top of and / or under the ends of the rolled strip or sheet to be welded, then welding one or more strips along the ends of the rolled strip or sheet, and then grinding the outer strip; or c) laser welding the ends of the rolled sheet or strip in a vacuum, oxygen-reduced atmosphere, or inert atmosphere. In yet another and / or additional non-limiting process, a near-net frame of a medical device or a part of a medical device (e.g., a frame of a medical device) made of a refractory metal alloy or metal alloy containing at least 15 wt.% rhenium, a blank, rod, tube, etc. are formed by adhering metal powder. In this process, fine particles of a metal (e.g., Re, W, Mo, Ti, Cu, Ni, Cr, etc.) are mixed with any additives to form a homogeneous blend of particles. Typically, the average particle size of the metal powder is less than about 200 mesh (e.g., less than 74 microns, 2 - 74 microns, and all values and ranges therebetween). A larger average particle size can potentially impede proper mixing of the metal powder and / or adversely affect one or more physical properties of a near-net frame of a medical device or a part of a medical device (e.g., a frame of a medical device), a blank, rod, tube, etc. formed from the metal powder. In one non-limiting embodiment, the average particle size of the metal powder is less than about 230 mesh (e.g., less than 63 microns). In another and / or alternative non-limiting embodiment, the average particle size of the metal powder is about 2 - 63 microns, more specifically, about 5 - 40 microns. As can be understood, smaller average particle sizes can be used. The purity of the metal powder should be selected such that the metal powder contains very low levels of carbon, oxygen, and nitrogen.Typically, the carbon content of the metal powder used to form a refractory metal alloy or metal alloy containing at least 15 wt.% rhenium is less than about 100 ppm, the oxygen content is less than about 50 ppm, and the nitrogen content is less than about 20 ppm. Typically, the metal powder used to form a refractory metal alloy or metal alloy containing at least 15 wt.% rhenium has a purity grade of at least 99.9, more typically at least about 99.95. The blend of metal powders is then pressed together to form a solid solution of a refractory metal alloy or metal alloy containing at least 15 wt.% rhenium into a near-net medical device or part of a medical device (e.g., the frame of a medical device, etc.), a blank, a rod, a tube, etc. Typically, the pressing process is by an isostatic pressing process (i.e., a uniform pressure applied from all sides of the metal powder), but other processes can also be used. When the metal powders are isostatically pressed together, cold isostatic pressing (CIP) is typically used to fix the metal powders, but this is not necessary. The pressing process can be carried out under an inert atmosphere, an oxygen-reducing atmosphere (e.g., hydrogen, argon, and hydrogen mixtures, etc.) and / or under vacuum, but this is not essential. The average density of the near-net medical device or part of a medical device (e.g., the frame of a medical device, etc.), a blank, a rod, a tube, etc. achieved by pressing the metal powders together is about 80-95% of the final average density of the near-net medical device or part of a medical device (e.g., the frame of a medical device, etc.), a blank, a rod, a tube, etc. (as well as all values and ranges therebetween), or about 70-99% of the minimum theoretical density of a refractory metal alloy or metal alloy containing at least 15 wt.% rhenium (as well as all values and ranges therebetween). A pressing pressure of at least about 300 MPa (e.g., 300-800 MPa and all values and ranges therebetween) is generally used. Usually, the pressing pressure is about 400-700 MPa, but other pressures can also be used.After the metal powders are pressed together, the pressed metal powders are sintered at a temperature of at least 1600 °C (e.g., 1600 - 3500 °C, and all values and ranges therebetween) to fuse the metal powders together partially or completely to form a near-net medical device or a part of a medical device (e.g., a frame of a medical device, etc.), a blank, a rod, a tube, etc. The sintering of the adhered metal powders can be carried out in an oxygen reduction atmosphere (e.g., helium, argon, hydrogen, argon, and hydrogen mixtures, etc.) and / or under vacuum, but this is not essential. At high sintering temperatures, a high hydrogen atmosphere reduces both the amount of carbon and oxygen in the formed near-net medical device or a part of a medical device (e.g., a frame of a medical device, etc.), a blank, a rod, a tube, etc. The sintered metal powders generally have a sintered average density of about 90 - 99.9% (and all values and ranges therebetween) of the minimum theoretical density of a refractory metal alloy or a metal alloy containing at least 15 wt.% rhenium. Typically, a sintered refractory metal alloy or a metal alloy containing at least 15 wt.% rhenium has a final average density of at least about 5 g / cc (e.g., 5 - 20 g / cc and all values and ranges therebetween), typically at least about 8.3 g / cc, and may be up to about 16 g / cc or more, but this is not essential. The density of the formed near-net medical device or a part of a medical device (e.g., a frame of a medical device, etc.), a blank, a rod, a tube, etc. generally depends on the type of refractory metal alloy or metal alloy containing at least 15 wt.% rhenium used.

[0082] According to another and / or alternative non-limiting aspect of the present disclosure, when a solid rod of a refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium is formed, the rod is formed into a tube before reducing the outer cross-sectional area or diameter of the rod. The rod can be formed into the tube by various processes such as cutting or drilling (e.g., gun drilling, etc.) or cutting (e.g., EDM, EDM sinker, wire EDM, etc.) or 3D printing, etc., but is not limited thereto. The cavity or passage formed within the rod is typically formed completely through the rod, but this is not essential.

[0083] Furthermore, in further and / or alternative non-limiting aspects of the present disclosure, a near-net medical device or a part of a medical device (e.g., the frame of a medical device, etc.), a blank, a rod, a tube, etc. can be sized to the desired dimensions of the medical device. In one non-limiting embodiment, the cross-sectional area or diameter of a near-net medical device or a part of a medical device (e.g., the frame of a medical device, etc.), a blank, a rod, a tube, etc. is reduced to the dimensions of the final near-net medical device or a part of a medical device (e.g., the frame of a medical device, etc.), a blank, a rod, a tube, etc. by a single step or a series of steps. The reduction in the outer cross-sectional area or diameter of a near-net medical device or a part of a medical device (e.g., the frame of a medical device, etc.), a blank, a rod, a tube, etc. can be obtained by centerless grinding, turning, electropolishing, a drawing process, grinding, laser cutting, shaving, polishing, EDM cutting, etc. The outer cross-sectional area or diameter size of a near-net medical device or a part of a medical device (e.g., the frame of a medical device, etc.), a blank, a rod, a tube, etc. can be reduced by using one or more drawing processes, but this is not essential. During the drawing process, care must be taken so that no microcracks are formed in the near-net medical device or a part of a medical device (e.g., the frame of a medical device, etc.), a blank, a rod, a tube, etc. during the reduction of the outer cross-sectional area or diameter.

[0084] In another and / or alternative non-limiting aspect of the present disclosure, each time the size of a near-net medical device or a part of a medical device (e.g., the frame of a medical device, etc.), a blank, a rod, a tube, etc. is reduced by drawing, the cross-sectional area of the near-net medical device or a part of a medical device (e.g., the frame of a medical device, etc.), a blank, a rod, a tube, etc. generally does not reduce by more than about 25% (e.g., 0.1 - 25% and all values and ranges therebetween). When a near-net medical device or a part of a medical device (e.g., the frame of a medical device, etc.), a blank, a rod, a tube, etc. optionally includes a nitride layer, the nitride layer can optionally function as a lubricating surface during the drawing process to facilitate the drawing of the near-net medical device or a part of a medical device (e.g., the frame of a medical device, etc.), a blank, a rod, a tube, etc. Generally, each time a near-net medical device or a part of a medical device (e.g., the frame of a medical device, etc.), a blank, a rod, a tube, etc. is drawn through a reducing mechanism, the cross-sectional area of the near-net medical device or a part of a medical device (e.g., the frame of a medical device, etc.), a blank, a rod, a tube, etc. reduces by about 0.1 - 20%. In another and / or alternative non-limiting process step, each time a near-net medical device or a part of a medical device (e.g., the frame of a medical device, etc.), a blank, a rod, a tube, etc. is drawn through a reducing mechanism, the cross-sectional area of the near-net medical device or a part of a medical device (e.g., the frame of a medical device, etc.), a blank, a rod, a tube, etc. reduces by about 1 - 15%. In yet another and / or alternative non-limiting process step, each time a near-net medical device or a part of a medical device (e.g., the frame of a medical device, etc.), a blank, a rod, a tube, etc. is drawn through a reducing mechanism, the cross-sectional area of the near-net medical device or a part of a medical device (e.g., the frame of a medical device, etc.), a blank, a rod, a tube, etc. reduces by about 2 - 15%.In yet another non-limiting process step, each time a near-net medical device or a part of a medical device (e.g., the frame of a medical device, etc.), a blank, a rod, a tube, etc. is drawn through a reducing mechanism, the cross-sectional area of the near-net medical device or a part of a medical device (e.g., the frame of a medical device, etc.), a blank, a rod, a tube, etc. is reduced by about 5-10%. In another and / or alternative non-limiting embodiment of the present disclosure, a near-net medical device or a part of a medical device (e.g., the frame of a medical device, etc.), a blank, a rod, a tube, etc. made of a refractory metal alloy or a metal alloy containing at least 15 wt.% of rhenium is drawn through a die to reduce the cross-sectional area of the near-net medical device or a part of a medical device (e.g., the frame of a medical device, etc.), a blank, a rod, a tube, etc. Generally, before drawing a near-net medical device or a part of a medical device (e.g., the frame of a medical device, etc.), a blank, a rod, a tube, etc. through a die, one end of the near-net medical device or a part of a medical device (e.g., the frame of a medical device, etc.), a blank, a rod, a tube, etc. is tapered (nosed) to allow it to be fed through the die, but this is not essential. The tube drawing process is typically a cold drawing process or a plug drawing process through a die. When a cold drawing process or a mandrel drawing process is used, a lubricant (e.g., molybdenum paste, grease, etc.) is typically coated on the outer surface of the near-net medical device or a part of a medical device (e.g., the frame of a medical device, etc.), a blank, a rod, a tube, etc., and then the near-net medical device or a part of a medical device (e.g., the frame of a medical device, etc.), a blank, a rod, a tube, etc. is drawn through the die. Typically, little or no heat is used during the cold drawing process.A near-net medical device or a part of a medical device (e.g., the frame of a medical device, etc.), a blank, a rod, a tube, etc. are drawn through a die, and then the outer surface of the near-net medical device or a part of a medical device (e.g., the frame of a medical device, etc.), a blank, a rod, a tube, etc. is typically washed with a solvent to remove lubricant and limit the amount of impurities incorporated into a refractory metal alloy or a metal alloy containing at least 15 wt.% of rhenium, although this is not essential. This cold drawing process can be repeated several times until the desired outer cross-sectional area or diameter, inner cross-sectional area or diameter, and / or wall thickness of the near-net medical device or a part of a medical device (e.g., the frame of a medical device, etc.), a blank, a rod, a tube, etc. are achieved. The plug drawing process can also be used, or alternatively, to dimension a near-net medical device or a part of a medical device (e.g., the frame of a medical device, etc.), a blank, a rod, a tube, etc. The plug drawing process typically does not use lubricant during the drawing process. The plug drawing process typically includes a heating step for heating the near-net medical device or a part of a medical device (e.g., the frame of a medical device, etc.), a blank, a rod, a tube, etc. through a die before and / or during the drawing of the near-net medical device or a part of a medical device (e.g., the frame of a medical device, etc.), a blank, a rod, a tube, etc. By eliminating the use of lubricant, the incidence of impurities being introduced into a refractory metal alloy or a metal alloy containing at least 15 wt.% of rhenium during the drawing process can be reduced. During the plug drawing process, the near-net medical device or a part of a medical device (e.g., the frame of a medical device, etc.), a blank, a rod, a tube, etc. can be protected from oxygen by using a vacuum environment, a non-oxygen environment (e.g., hydrogen, argon and hydrogen mixture, nitrogen, nitrogen and hydrogen, etc.), or an inert environment. One non-limiting protective environment includes argon, hydrogen or argon and hydrogen, but other or additional inert gases can also be used.As described above, near-net medical devices or parts of medical devices (e.g., frames of medical devices, etc.), blanks, rods, tubes, etc. are typically cleaned after each drawing process to remove impurities and / or other undesirable materials from the surfaces of near-net medical devices or parts of medical devices (e.g., frames of medical devices, etc.), blanks, rods, tubes, etc., although this is not essential. Typically, when the temperature of near-net medical devices or parts of medical devices (e.g., frames of medical devices, etc.), blanks, rods, tubes, etc. rises above 500 °C, typically above 450 °C, and more typically above 400 °C, near-net medical devices or parts of medical devices (e.g., frames of medical devices, etc.), blanks, rods, tubes, etc. should be shielded from oxygen and nitrogen, although this is not essential. When near-net medical devices or parts of medical devices (e.g., frames of medical devices, etc.), blanks, rods, tubes, etc. are heated to temperatures above about 400 - 500 °C, near-net medical devices or parts of medical devices (e.g., frames of medical devices, etc.), blanks, rods, tubes, etc. tend to start forming in the presence of nitrides and / or nitrogen and oxygen. In these high-temperature environments, hydrogen environments, argon and hydrogen environments, etc. are generally used. When near-net medical devices or parts of medical devices (e.g., frames of medical devices, etc.), blanks, rods, tubes, etc. are drawn at temperatures below 400 - 500 °C, near-net medical devices or parts of medical devices (e.g., frames of medical devices, etc.), blanks, rods, tubes, etc. can be exposed to air with little or no harmful effects, although an inert or slightly reducing environment is generally more desirable.

[0085] In another and / or alternative non-limiting aspect of the present disclosure, near-net medical devices or parts of medical devices (e.g., the frame of a medical device, etc.), blanks, rods, tubes, etc. are cooled after annealing, although this is not necessary. Generally, near-net medical devices or parts of medical devices (e.g., the frame of a medical device, etc.), blanks, rods, tubes, etc. are cooled at a fairly rapid rate after annealing to inhibit or prevent the formation of sigma phase in a refractory metal alloy or metal alloy containing at least 15 wt.% rhenium, although this is not essential. Generally, near-net medical devices or parts of medical devices (e.g., the frame of a medical device, etc.), blanks, rods, tubes, etc. are cooled at a rate of at least about 50 °C per minute (e.g., 50 - 500 °C per minute, and all values and ranges therebetween) after annealing, typically at least about 75 °C per minute after annealing, more typically at least about 100 °C per minute after annealing, even more typically about 100 - 400 °C per minute after annealing, even more typically about 150 - 350 °C per minute after annealing, still even more typically about 200 - 300 °C per minute after annealing, and even still more typically about 250 - 280 °C per minute after annealing, although this is not essential.

[0086] In another and / or alternative non-limiting aspect of the present disclosure, a near-net medical device or a part of a medical device (e.g., a frame of a medical device, etc.), a blank, a rod, a tube, etc. is annealed after one or more drawing processes. A refractory metal alloy or a metal alloy containing at least 15 wt.% rhenium blanks, rods, tubes, etc. can be annealed after each drawing process or after a plurality of drawing processes. A refractory metal alloy or a metal alloy containing at least 15 wt.% rhenium blanks, rods, tubes, etc. is typically annealed before a reduction in size of about 60% of the cross-sectional area of the refractory metal alloy or the metal alloy containing at least 15 wt.% rhenium blanks, rods, tubes, etc. In other words, before annealing, the cross-sectional area of a near-net medical device or a part of a medical device (e.g., a frame of a medical device, etc.), a blank, a rod, a tube, etc. should not be reduced by more than 60% (e.g., a reduction of 0.1 - 60% and all values and ranges therebetween). An overly large reduction in the cross-sectional area of a refractory metal alloy or a metal alloy containing at least 15 wt.% rhenium blanks, rods, tubes, etc. can result in microcracks in the near-net medical device or a part of a medical device (e.g., a frame of a medical device, etc.), a blank, a rod, a tube, etc. during the drawing process before the near-net medical device or a part of a medical device (e.g., a frame of a medical device, etc.), a blank, a rod, a tube, etc. is annealed. In one non-limiting processing step, a refractory metal alloy or a metal alloy containing at least 15 wt.% rhenium blanks, rods, tubes, etc. is annealed before a reduction in size of about 50% of the cross-sectional area of the refractory metal alloy or the metal alloy containing at least 15 wt.% rhenium blanks, rods, tubes, etc. In another and / or alternative non-limiting processing step, a refractory metal alloy or a metal alloy containing at least 15 wt.% rhenium blanks, rods, tubes, etc. is annealed before a reduction in size of about 45% of the cross-sectional area of the refractory metal alloy or the metal alloy containing at least 15 wt.% rhenium blanks, rods, tubes, etc.According to another and / or alternative non-limiting aspect of the present disclosure, a refractory metal alloy or metal alloy comprising at least 15 wt.% rhenium blanks, rods, tubes, etc. is annealed before the size of the cross-sectional area of the refractory metal alloy or metal alloy comprising at least 15 wt.% rhenium blanks, rods, tubes, etc. is reduced by about 1 to 45%. In yet another and / or alternative non-limiting processing step, a refractory metal alloy or metal alloy comprising at least 15 wt.% rhenium blanks, rods, tubes, etc. is annealed before a reduction in the size of the cross-sectional area of the refractory metal alloy or metal alloy comprising at least 15 wt.% rhenium blanks, rods, tubes, etc. of about 5 to 30%. In yet another and / or alternative non-limiting processing step, a refractory metal alloy or metal alloy comprising at least 15 wt.% rhenium blanks, rods, tubes, etc. is annealed before a reduction in the size of the cross-sectional area of the refractory metal alloy or metal alloy comprising at least 15 wt.% rhenium blanks, rods, tubes, etc. of about 5 to 15%.

[0087] According to another and / or alternative non-limiting aspect of the present disclosure, when a near-net medical device or a part of a medical device (e.g., the frame of a medical device, etc.), a blank, a rod, a tube, etc. is annealed, the near-net medical device or a part of a medical device (e.g., the frame of a medical device, etc.), a blank, a rod, a tube, etc. is typically heated to a temperature of about 500 to 1700 °C (and all values and ranges therebetween) for a time of about 1 to 200 minutes (and all values and ranges therebetween), although other temperatures and / or times can also be used. In one non-limiting processing step, a near-net medical device or a part of a medical device (e.g., the frame of a medical device, etc.), a blank, a rod, a tube, etc. is annealed at a temperature of about 1000 to 1600 °C for about 2 to 100 minutes. In another non-limiting processing step, a near-net medical device or a part of a medical device (e.g., the frame of a medical device, etc.), a blank, a rod, a tube, etc. is annealed at a temperature of about 1100 to 1500 °C for about 5 to 30 minutes. The annealing process is typically carried out in an inert environment or an oxygen-reducing environment so as to limit the amount of impurities that can be embedded in a refractory metal alloy or a metal alloy containing at least 15 wt.% of rhenium during the annealing process. One non-limiting oxygen-reducing environment that can be used during the annealing process is a hydrogen environment, although it can also be understood that a vacuum environment can be used or an oxygen-reducing environment can be created using one or more other or additional gases. At the annealing temperature, a hydrogen-containing atmosphere can further reduce the amount of oxygen in a near-net medical device or a part of a medical device (e.g., the frame of a medical device, etc.), a blank, a rod, a tube, etc.The chamber in which a near-net medical device or a part of a medical device (e.g., the frame of a medical device, etc.), a blank, a rod, a tube, etc. is annealed should be substantially free of impurities (e.g., carbon, oxygen, nitrogen, etc.) (e.g., 0 - 50 ppm and all values and ranges in between) so as to limit the amount of impurities that can be embedded in the near-net medical device or a part of a medical device (e.g., the frame of a medical device, etc.), a blank, a rod, a tube, etc. during the annealing process. The annealing chamber is typically formed from a material that does not impart impurities to the near-net medical device or a part of a medical device (e.g., the frame of a medical device, etc.), a blank, a rod, a tube, etc. when the near-net medical device or a part of a medical device (e.g., the frame of a medical device, etc.), a blank, a rod, a tube, etc. is annealed. Non-limiting materials that can be used to form the annealing chamber include, but are not limited to, molybdenum, rhenium, tungsten, molybdenum TZM alloy, cobalt, chromium, ceramic, etc. When the near-net medical device or a part of a medical device (e.g., the frame of a medical device, etc.), a blank, a rod, a tube, etc. is constrained within the annealing chamber, the constraining device used to contact the near-net medical device or a part of a medical device (e.g., the frame of a medical device, etc.), a blank, a rod, a tube, etc. is typically formed from a material that does not introduce impurities into a refractory metal alloy or a metal alloy containing at least 15 wt.% rhenium during the processing of the near-net medical device or a part of a medical device (e.g., the frame of a medical device, etc.), a blank, a rod, a tube, etc. Non-limiting examples of materials that can be used to at least partially form the constraining device include, but are not limited to, molybdenum, titanium, yttrium, zirconium, rhenium, cobalt, chromium, tantalum, and / or tungsten.In one non-limiting embodiment, when a refractory metal alloy or metal alloy containing at least 15 wt.% rhenium is exposed to a temperature above 150 °C for any process step including annealing, during the processing of the refractory metal alloy or metal alloy containing at least 15 wt.% rhenium, the material contacting the refractory metal alloy or metal alloy containing at least 15 wt.% rhenium is typically made from chromium, cobalt, molybdenum, rhenium, tantalum, and / or tungsten. When the refractory metal alloy or metal alloy containing at least 15 wt.% rhenium is processed at a lower temperature (i.e., 150 °C or less), materials made from Teflon (trademark) parts may also or alternatively be used.

[0088] According to another and / or alternative non-limiting aspect of the present disclosure, the parameters for annealing can be changed as cross-sectional area or diameter, for a near-net medical device or a part of a medical device (e.g., a frame of a medical device, etc.), a blank, a rod, a tube, etc., and / or the wall thickness of a near-net medical device or a part of a medical device (e.g., a frame of a medical device, etc.), a blank, a rod, a tube, etc. is changed. It has been found that good grain size characteristics of a near-net medical device or a part of a medical device (e.g., a frame of a medical device, etc.), a blank, a rod, a tube, etc. can be achieved when the annealing parameters change as parameters of the change of a near-net medical device or a part of a medical device (e.g., a frame of a medical device, etc.), a blank, a rod, a tube, etc. For example, as the wall thickness is reduced, the annealing temperature is correspondingly reduced, but the annealing time can be increased. As can be understood, the annealing temperature of a near-net medical device or a part of a medical device (e.g., a frame of a medical device, etc.), a blank, a rod, a tube, etc. can be reduced as the wall thickness decreases, but the annealing time can remain the same or also be reduced as the wall thickness is reduced. After each annealing process, the grain size of the metal of a near-net medical device or a part of a medical device (e.g., a frame of a medical device, etc.), a blank, a rod, a tube, etc. should be 4 ASTM or less. Generally, the range of grain size is about 4 - 20 ASTM (as well as all values and ranges in between). Since the annealing temperature is reduced as the wall thickness is reduced, it is considered that a small grain size can be obtained. The grain size of the metal of a near-net medical device or a part of a medical device (e.g., a frame of a medical device, etc.), a blank, a rod, a tube, etc. should be as uniform as possible. In addition, the sigma phase of the metal of a near-net medical device or a part of a medical device (e.g., a frame of a medical device, etc.), a blank, a rod, a tube, etc. should be reduced as much as possible. The sigma phase is a spherical, elliptical or square crystal shape in a refractory metal alloy or a metal alloy containing at least 15 wt.% of rhenium.Near-net medical devices or parts of medical devices (e.g., the frame of a medical device, etc.), blanks, rods, tubes, etc. After the final drawing, near-net medical devices or parts of medical devices (e.g., the frame of a medical device, etc.), blanks, rods, tubes, etc. can be subjected to final annealing for final strengthening of near-net medical devices or parts of medical devices (e.g., the frame of a medical device, etc.), blanks, rods, tubes, etc., but this is not essential. This final annealing process, when used, is generally carried out at a temperature of about 500 - 1600 °C (and all values and ranges in between) for at least about 1 minute, although other temperatures and / or times can also be used.

[0089] According to another and / or alternative non-limiting aspect of the present disclosure, the use of a refractory metal alloy or a metal alloy comprising at least 15 wt.% rhenium for partially or fully forming a medical device or a part of a medical device (e.g., the frame of a medical device, etc.) can be used to increase the strength and / or hardness and / or durability of the medical device or a part of the medical device (e.g., the frame of a medical device, etc.) as compared to stainless steel or a chromium-cobalt alloy or a titanium alloy. Thus, a smaller amount of a refractory metal alloy or a metal alloy comprising at least 15 wt.% rhenium can be used in a medical device or a part of a medical device (e.g., the frame of a medical device, etc.) to achieve a similar strength as compared to the frame of a medical device formed from a different metal. In this way, the resulting medical device can be made smaller and less bulky without sacrificing the strength and durability of the medical device by using a refractory metal alloy or a metal alloy comprising at least 15 wt.% rhenium. Such a medical device can have a smaller profile and thus can be inserted into a smaller area, opening, and / or passage. A refractory metal alloy or a metal alloy comprising at least 15 wt.% rhenium can also increase the radial strength of a medical device or a part of a medical device (e.g., the frame of a medical device, etc.). For example, the thickness of the wall of a medical device or a part of a medical device (e.g., the frame of a medical device, etc.), and / or the wire used to at least partially form a medical device or a part of a medical device (e.g., the frame of a medical device, etc.) can be made thinner, and a similar or improved radial strength can be achieved as compared to the thicker-walled frame of a medical device formed from stainless steel, a titanium alloy, or a cobalt and chromium alloy. A refractory metal alloy or a metal alloy comprising at least 15 wt.% rhenium can also improve the stress-strain characteristics, bendability, and flexibility of a medical device or a part of a medical device (e.g., the frame of a medical device, etc.), and thus can extend the lifespan of the medical device. For example, the medical device can be used in areas where the medical device is bent.For improved physical properties of medical devices from refractory metal alloys or metal alloys containing at least 15 wt.% rhenium, the medical devices have improved resistance to fracture in such frequent bending environments. Additionally or alternatively, the improved bendability and / or flexibility of a medical device or a part of a medical device (e.g., the frame of a medical device, etc.) by using a refractory metal alloy or metal alloy containing at least 15 wt.% rhenium can enable easier insertion of the medical device into various regions of the body. In the case of a medical device configured to be crimped (e.g., a stent, the frame of a heart valve, etc.), a refractory metal alloy or metal alloy containing at least 15 wt.% rhenium can also reduce the degree of reaction during crimping and / or expansion of the medical device or a part of the medical device (e.g., the frame of the medical device, etc.). For example, due to the use of a refractory metal alloy or metal alloy containing at least 15 wt.% rhenium, the medical device can better maintain its crimped form and / or better maintain its expanded form after expansion. Thus, when attaching the medical device to a delivery device when the medical device is crimped, the medical device can better maintain its smaller profile during insertion of the medical device into various regions of the body. Also, the medical device can better maintain its expanded profile after expansion to facilitate the success of the medical device in the treatment area. In addition to the improved physical properties of the medical device by using a refractory metal alloy or metal alloy containing at least 15 wt.% rhenium, the refractory metal alloy or metal alloy containing at least 15 wt.% rhenium has improved radiopacity properties compared to standard materials such as stainless steel or cobalt-chromium alloys, and thus reduces or eliminates the need to use marker materials on the medical device. For example, a refractory metal alloy or metal alloy containing at least 15 wt.% rhenium is thought to have at least about 10 - 20% higher radiopacity than stainless steel or cobalt-chromium alloys.

[0090] According to another and / or alternative non-limiting aspect of the present disclosure, a refractory metal alloy or metal alloy containing at least 15 wt.% rhenium is subjected to a final heat treatment process along a part or all of the longitudinal length of a piece of refractory metal alloy or metal alloy containing at least 15 wt.% rhenium used to partially or fully form a medical device. The final heat treatment process is used to soften a refractory metal alloy or metal alloy containing at least 15 wt.% rhenium (e.g., increase flexibility, increase bendability, decrease yield strength and / or ultimate tensile strength). As the distance to the heated portion of the piece of refractory metal alloy or metal alloy containing at least 15 wt.% rhenium increases, the force decreases and breaks the piece of refractory metal alloy or metal alloy containing at least 15 wt.% rhenium. This is a result of the decrease in the yield strength and / or ultimate tensile strength of the piece of refractory metal alloy or metal alloy containing at least 15 wt.% rhenium as the temperature increases during the final heat treatment of the piece of refractory metal alloy or metal alloy containing at least 15 wt.% rhenium. During the final heat treatment, the crystal structure of the piece of refractory metal alloy or metal alloy containing at least 15 wt.% rhenium rod and the stress relaxation, which can be a result of prior cold working and / or annealing of the piece of refractory metal alloy or metal alloy containing at least 15 wt.% rhenium, are reconfigured. Generally, there is no quench of the refractory metal alloy or metal alloy containing at least 15 wt.% rhenium after the final heat treatment process. Thus, the heated refractory metal alloy or metal alloy containing at least 15 wt.% rhenium can be cooled simply by exposure to the ambient temperature of the atmosphere surrounding the heated refractory metal alloy or metal alloy containing at least 15 wt.% rhenium (e.g., a non-oxidizing gas environment at a temperature of 10 - 100°C and all values and ranges therebetween, an inert gas environment at a temperature of 10 - 100°C and all values and ranges therebetween, an atmospheric environment at a temperature of 10 - 100°C and all values and ranges therebetween, etc.).Generally, the cooling rate after the final heat treatment step is less than 100 °C / second (e.g., less than 1 to 100 °C / second and all values and ranges therebetween), typically less than 50 °C / second, more typically less than 25 °C / second. The final heat treatment can be uniform or non-uniform along the longitudinal length of a piece of a refractory metal alloy or a metal alloy containing at least 15 wt.% rhenium used to partially or fully form a medical device. The time of the final heat treatment at different positions along the longitudinal length of a piece of a refractory metal alloy or a metal alloy containing at least 15 wt.% rhenium used to partially or fully form a medical device may be the same or different. The temperature of the final heat treatment at different positions along the longitudinal length of a piece of a refractory metal alloy or a metal alloy containing at least 15 wt.% rhenium used to partially or fully form a medical device may be the same or different. In one non-limiting embodiment, the portion of the piece of a refractory metal alloy or a metal alloy containing at least 15 wt.% rhenium subjected to the final heat treatment is a) exposed to a uniform temperature for a uniform time, b) enabled to be cooled at a substantially the same cooling rate, and c) not subjected to quenching.

[0091] According to another and / or alternative non-limiting aspect of the present disclosure, a refractory metal alloy or metal alloy containing at least 15 wt.% rhenium is subjected to a final heat treatment process along a portion of the longitudinal length of a piece of refractory metal alloy or metal alloy containing at least 15 wt.% rhenium used to partially or fully form a medical device, and a heat shield is used to prevent a portion of the piece of metal alloy from being subjected to the final heat treatment. The type of heat shielding is non-limiting. In one non-limiting configuration, heat shielding is achieved by inserting only a portion of a piece of refractory metal alloy or metal alloy containing at least 15 wt.% rhenium into an oven. In one non-limiting configuration, an opening is provided in the outer surface of the heating oven (e.g., a sand furnace, etc.) that allows a portion of a piece of refractory metal alloy or metal alloy containing at least 15 wt.% rhenium to be inserted into the interior of the heating oven. The position of the opening is non-limiting. In another non-limiting configuration, the opening is within an oven cover or furnace cover. A piece of refractory metal alloy or metal alloy containing at least 15 wt.% rhenium (e.g., a MoRe alloy, etc.) can be formed from a rod, but this is not essential. Such a rod can be used for spinal surgery, but the rod can also be used for other medical procedures. The rod can have a generally uniform cross-sectional shape and area along most (50 - 99.9% and all values and ranges therebetween) or all of the longitudinal length of the rod. In one non-limiting configuration, the portion of the rod located within the heating oven is exposed to a temperature of up to 1000 °C (e.g., 100 - 1000 °C and all values and ranges therebetween). In one specific non-limiting configuration, the portion of the rod disposed within the furnace is first exposed to a temperature of 10 - 250 °C (and all values and ranges therebetween, 90 - 160 °C) (e.g., a preheating step), then the heat is increased to 500 - 1000 °C (and all values and ranges therebetween, 550 - 700 °C) over 0.5 - 10 hours (and all values and ranges therebetween, 1 - 3 hours), and then the heat within the heating oven is maintained at the maximum temperature for 1 - 15 hours (and all values and ranges therebetween, 2 - 10 hours).Heating the rod in the heating furnace results in the heated portion having a reduced yield strength and / or a reduced ultimate tensile strength, thereby making the heated portion of the rod more flexible or bendable than the portion of the rod that was not inserted into the heating furnace. During the final heating of the rod, a portion of the rod can be withdrawn from the heating oven during the heating time such that the lower portion of the rod is heated in the heating oven for a longer time than the middle portion of the rod. Such heating of the rod can result in the lower portion of the rod being heated for a longer time such that it has a lower yield strength and / or ultimate tensile strength than the middle portion of the rod, thereby making the lower portion of the rod more flexible or bendable than the middle and upper portions that were not inserted into the heating oven. Generally, there is no quench of the refractory metal alloy or metal alloy containing at least 15 wt.% rhenium after the final heat treatment process. Thus, the heated refractory metal alloy or metal alloy containing at least 15 wt.% rhenium can be cooled simply by exposure to the ambient temperature of the atmosphere surrounding the heated refractory metal alloy or metal alloy containing at least 15 wt.% rhenium (e.g., a non-oxidizing gas environment at a temperature of 10 - 100 °C and all values and ranges therebetween, an inert gas environment at a temperature of 10 - 100 °C and all values and ranges therebetween, an air environment at a temperature of 10 - 100 °C and all values and ranges therebetween, etc.). Generally, the cooling rate after the final heat treatment step is less than 100 °C / second (e.g., less than 1 - 100 °C / second and all values and ranges therebetween), typically less than 50 °C / second, more typically less than 25 °C / second.

[0092] According to another and / or alternative non-limiting aspect of the present disclosure, the rod being subjected to final heating can be up to 40 inches in length (e.g., 2 to 40 inches and all values and ranges therebetween, such as up to 20 inches), and after cutting, it can be of a desired length (e.g., 20 to 500 mm [and all values and ranges therebetween], 3 to 8 mm in diameter [and all values and ranges therebetween]). It will be understood that other rod lengths can be used. As can be understood, the cut portion of the rod can be a) the portion of the rod that was subjected to the final heating process, b) the portion of the rod that was not subjected to the final heating process, or c) a portion of the rod that was subjected to the final heating process and a portion that was not subjected to the final heating process. The physical properties of the rod portions of a) and b) can be uniform or substantially uniform along the longitudinal length of the rod portion, and the physical properties of the rod portion of c) are likely to vary along the longitudinal length of the rod portion.

[0093] According to another and / or alternative non-limiting aspect of the present disclosure, rods having different degrees of flexibility or bendability but the same cross-sectional size and shape along the longitudinal length of the rod can be formed for use in certain medical procedures. Thus, a medical professional can use spinal rods of the same size during a medical procedure (e.g., spinal surgery), but simply select a rod having the desired flexibility or bendability for use in a particular region of the spine. Thus, the need to use ground rods of different diameters in a medical procedure can be eliminated. Thus, the support structure for use with the spinal rod can be of uniform size and used to simplify the medical procedure and reduce errors during the medical procedure, and a single size of screw (e.g., pedicle screw) can be used to secure the rod to other spinal structures. The spinal rod may be color-coded (e.g., color coating, etc.) or may have other or additional markings indicating the flexibility or bendability of the rod. Such color-coding or markings can be used to easily identify by a medical professional which spinal rod should be selected for use at a particular location of a spinal surgery. Thus, a plurality of spinal rods having the same cross-sectional size and shape along the longitudinal length of the rod but different yield strengths and / or ultimate tensile strengths can be represented by color-coding or markings so that a medical professional can easily identify the rods available to the medical professional during a medical procedure, and the color-coding or markings enable the medical professional to quickly, easily, and accurately identify the desired spinal rod for use at a particular location of a spinal surgery. Historically, thinner diameter rods have been used for spinal surgery in the upper part of the spine, and larger diameter rods have been used for spinal surgery in the lower part of the spine. The smaller diameter rods allowed for more flexibility or bendability of the spine after spinal surgery at spinal locations closer to the head where more flexibility or bendability was desired. However, at the lower part of the spine where less flexibility or bendability was desired after spinal surgery, thicker diameter spinal rods were desired.After spinal surgery, an intermediate thickness diameter spinal rod was desired at the position between the upper and lower portions of the spine because an intermediate flexibility or bendability was desired at such a position. Thus, multiple diameter rods had to be provided during the surgical procedure so that an appropriate rod having the desired flexibility or bendability could be used. One problem with grinding the rod to form rods of different diameters was that the screws (e.g., pedicle screws) used to properly secure the rod had to be changed based on the diameter of the rod. The upper portion of the screw includes a rod opening of a specific diameter and shape. This selection of the appropriate screw can make it difficult for the surgeon to determine which screw was the appropriate screw for use with a particular diameter rod. By being able to use a rod of uniform diameter that can have variable flexibility or bendability in accordance with the present disclosure, the surgeon's time can be saved, inventory can be reduced, the likelihood of surgical error can be reduced, and a better surgery (more uniform alignment of the spine) for the patient can be provided.

[0094] According to another and / or alternative non-limiting aspect of the present disclosure, a rod or strut is provided in which different portions of the rod or strut along the longitudinal length of the rod or strut are heat treated in different amounts such that the rod or strut has a plurality of different physical properties along the longitudinal length of the rod or strut. In one non-limiting configuration, 10 to 50% (as well as all values and ranges therebetween) of the longitudinal length of the rod or strut is heat treated in a different amount than 10 to 50% (as well as all values and ranges therebetween) of the other portion of the rod or strut, the rod or strut is formed of a uniform composition, the rod or strut is formed as a uniform cross-sectional shape and area along the longitudinal length of the rod or strut, and the physical properties of the rod or strut (e.g., flexibility or bendability, buckling stress at break, displacement at break, force at break, etc.) are different along different regions along the longitudinal length of the rod or strut.

[0095] According to another and / or alternative non-limiting aspect of the present disclosure, a set of rods or struts for use in orthopedic or spinal procedures is provided, the plurality of rods or struts having different physical properties (e.g., flexure stress at break, displacement at break, force at break, etc.) along 60 to 100% (and all values and ranges therebetween) of the longitudinal length of the rods, each of the rods being color-coded and / or marked in some other way to indicate the relative physical properties of each rod so that a physician can visually identify the rod or strut having the specific physical properties for use in an orthopedic or spinal procedure. In such a configuration, a physician can select a rod or strut having the desired bendability and / or flexibility for use in a particular medical procedure and at a particular location of a patient.

[0096] According to another and / or alternative non-limiting aspect of the present disclosure, there is provided a method for manufacturing a plurality of medical devices formed from the same refractory metal alloy or metal alloy having the same or similar size, shape, and composition and containing at least 15 wt.% rhenium, but having different physical properties with respect to at least flexibility or bendability, yield strength, and / or ultimate tensile strength. In one non-limiting configuration, a) formed from the same metal alloy (e.g., refractory metal alloy [e.g., MoRe alloy, Re alloy, Mo alloy, Ta alloy, W alloy, etc.], metal alloy containing at least 15 wt.% rhenium, etc.), b) having exactly the same size, shape, and configuration, or having similar size, shape, and configuration (e.g., the devices have exactly the same size, shape, and configuration along 40 - 100% [and all values and ranges therebetween] of the longitudinal length of the device), c) having different physical properties with respect to at least flexibility or bendability, yield strength, and / or ultimate tensile strength, at least partially due to subjecting the metal alloy on the plurality of devices to different final heating processes, d) optionally, a plurality of devices (e.g., medical devices [e.g., spinal rods, spinal screws (e.g., pedicle screws), spinal struts, etc.], medical tools, etc.) having one or more markings (e.g., color coatings, etchings on the outer surface, symbols on the outer surface, etc.) used to visually indicate the properties or relative properties of the plurality of devices are provided.In another non-limiting configuration, a) formed from the same metal alloy (e.g., a refractory metal alloy containing at least 15 wt.% rhenium, a metal alloy, etc.), b) having similar size, shape, and configuration along 60 to 100% (and all values and ranges therebetween) of the longitudinal length of the medical device, c) having different physical properties (e.g., at least flexibility or bendability, yield strength, and / or ultimate tensile strength) along one or more portions of the medical device along the longitudinal length of the medical device, at least partially due to subjecting the metal alloy on the plurality of medical devices to different final heat processes (e.g., the upper portion of the medical device has different physical properties than the middle and / or lower portion of the medical device, the lower portion of the medical device has different physical properties than the middle portion of the medical device, etc.), d) a plurality of medical devices in the form of spinal rods, spinal screws, or spinal struts are provided, having one or more markings (e.g., color coating, etching on the outer surface, symbols on the outer surface, etc.) used to visually indicate the properties or relative properties of the plurality of medical devices.

[0097] According to another and / or alternative non-limiting aspect of the present disclosure, a method for using a medical device in the form of a spinal rod or spinal strut in a spinal surgical procedure, comprising: a) i) the same metal alloy (e.g., refractory metal alloy [e.g., MoRe alloy, Re alloy, Mo alloy, Ta alloy, W alloy, etc.], at least 15 wt.formed from, e.g., a metal alloy containing % of rhenium), ii) generally cylindrical, having a body member with a constant cross-sectional shape and a diameter of cross-sectional size along 60 - 100% (and all values and ranges therebetween) of the longitudinal length of the body member, iii) the body members of the plurality of spinal rods or spinal struts have different physical properties with respect to at least flexibility or bendability, yield strength, and / or ultimate tensile strength, at least partially due to subjecting the metal alloy on the body portions of the plurality of spinal rods or spinal struts to different final heating processes, iv) providing a plurality of spinal rods or spinal struts, wherein the spinal rod or spinal strut optionally has one or more markings (e.g., color coating, etching on the outer surface, symbols on the outer surface, etc.) used to visually indicate one or more properties or relative properties of the spinal rod or spinal strut, b) identifying the positions where the plurality of spinal rods or spinal struts are used in a spinal surgical procedure, c) determining the desired flexibility or bendability of each spinal rod or strut used at a specific location of the spine during a spinal surgical procedure, d) selecting a spinal rod or strut having the desired flexibility or bendability (and such selection is optionally based on the markings of the spinal rod or spinal strut), e) selecting spinal pedicle screws (e.g., pedicle screws) for use in a spinal procedure, each of the spinal pedicle screws including an upper portion having a strut opening configured to receive a portion of the spinal rod or spinal strut, such that the spinal rod or spinal strut can be fixed to the strut opening, thereby fixing the spinal rod or spinal strut to the upper portion of the spinal pedicle screw, and the shape, size, and configuration of the posting perforations for all of the plurality of spinal pedicle screws being the same, f) inserting two or more spinal pedicle screws into a patient's bone (e.g., the spine, etc.), g) fixing the selected spinal rod or spinal strut having the desired flexibility or bendability to the spinal pedicle screw during a spinal surgical procedure, a method is provided.

[0098] According to another and / or alternative non-limiting aspect of the present disclosure, a method of providing spinal fusion components to a healthcare provider or healthcare system, comprising: a) providing a plurality of spinal screws or pedicle screws, each spinal screw including a body portion configured to be inserted into the spine and a head portion connected to the body portion, the head portion being configured to include a strut opening and a fixation device, the longitudinal length of the body portion being 20 to 80 mm (and all values and ranges therebetween), the strut opening being designed to allow a portion of a spinal rod or strut to be inserted therein, the configuration of the strut opening being the same as that of the spinal screw regardless of the longitudinal length of the body, and the fixation device being designed to fix a spinal rod or spinal strut to the strut opening; b) providing a plurality of spinal rods or spinal struts, i) formed from the same metal alloy (e.g., a refractory metal alloy [e.g., a MoRe alloy, a Re alloy, a Mo alloy, a Ta alloy, a W alloy, etc.], a metal alloy containing at least 15 wt.% rhenium, etc.), ii) generally cylindrical, having a diameter with a constant cross-sectional shape and cross-sectional size along 60 to 100% (and all values and ranges therebetween) of the longitudinal length of the body member, iii) the body members of the plurality of spinal rods or spinal struts having different physical properties with respect to at least flexibility or bendability, yield strength, and / or ultimate tensile strength, at least partially due to subjecting the metal alloy on the body portions of the plurality of spinal rods or spinal struts to different final heating processes, and iv) the spinal rod or spinal strut optionally having one or more markings (e.g., a color coating, an etching on the outer surface, a symbol on the outer surface, etc.) used to visually indicate one or more or all of the properties or relative properties of the spinal rod or spinal strut; c) enabling a healthcare provider or healthcare system to use the plurality of spinal screws provided for use in a particular medical procedure; and d) enabling a healthcare provider or healthcare system to use one or more of the spinal rods or struts provided for use in a particular medical procedure, the obtained spinal rod or spinal strut being appropriately adapted to and fixed in the opening of the spinal screw.

[0099] According to another and / or alternative non-limiting aspect of the present disclosure, the use of a refractory metal alloy or metal alloy comprising at least 15 wt.% rhenium to form all or a portion of a medical device can provide several advantages over medical devices formed from other materials. These advantages include, but are not limited to:

[0100] ● A refractory metal alloy or metal alloy comprising at least 15 wt.% rhenium has increased strength and / or hardness compared to stainless steel, chromium-cobalt alloys, or titanium alloys, so that a smaller amount of the refractory metal alloy or metal alloy comprising at least 15 wt.% rhenium can be used in a medical device to achieve similar strength compared to medical devices formed from different metals. Thus, the resulting medical device can be made smaller and less bulky without sacrificing the strength and durability of the medical device by using a refractory metal alloy or metal alloy comprising at least 15 wt.% rhenium. The medical device can also have a smaller profile and can thus be inserted into smaller areas, openings, and / or passageways. A thinner strut of a refractory metal alloy or metal alloy comprising at least 15 wt.% rhenium can be used to form the frame or other portion of the medical device to form a frame or other portion of a medical device having the strength that would require a thicker strut or other structure of the medical device if formed of stainless steel, chromium-cobalt alloy, or titanium alloy.

[0101] ● The increased strength of a refractory metal alloy or metal alloy comprising at least 15 wt.% rhenium also results in an increase in the radial strength of the medical device. For example, the wall thickness of the medical device can be made thinner, achieving equivalent or improved radial strength compared to a thicker-walled medical device formed from stainless steel, cobalt and chromium alloys, or titanium alloys.

[0102] ● A refractory metal alloy or metal alloy containing at least 15 wt.% rhenium has improved stress-strain characteristics, bending characteristics, elongation characteristics, and / or flexibility or bending characteristics of a medical device compared to stainless steel or a chromium-cobalt alloy, and thus results in an increase in the lifespan 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 a refractory metal alloy or metal alloy containing at least 15 wt.% rhenium, the medical device has improved resistance to cracking in such frequent bending environments. These improved physical properties are at least partially due to the composition of the refractory metal alloy or metal alloy containing at least 15 wt.% rhenium, the particle size of the refractory metal alloy or metal alloy containing at least 15 wt.% rhenium, the carbon, oxygen, and nitrogen contents of the refractory metal alloy or metal alloy containing at least 15 wt.% rhenium, and / or the carbon / oxygen ratio of the refractory metal alloy or metal alloy containing at least 15 wt.% rhenium.

[0103] ● A refractory metal alloy or metal alloy containing at least 15 wt.% rhenium is configured such that at least a portion of the medical device is configured to crimp and / or expand (e.g., a stent, a heart valve frame, etc.), and has a reduced degree of reaction during crimping and / or expansion of the medical device compared to stainless steel, a chromium-cobalt alloy, or a titanium alloy. A medical device formed from a refractory metal alloy or metal alloy containing at least 15 wt.% rhenium better maintains its crimped form and / or its expanded form after expansion by virtue of the use of the refractory metal alloy or metal alloy containing at least 15 wt.% rhenium. Thus, when attaching the medical device 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 the success of the medical device in the treatment area.

[0104] ● The use of a refractory metal alloy or a metal alloy containing at least 15 wt.% of rhenium in a medical device results in the medical device fitting well to an irregularly shaped body passage when expanded in a body passage, as compared to a medical device formed of stainless steel, a chromium-cobalt alloy, or a titanium alloy.

[0105] ● A refractory metal alloy or a metal alloy containing at least 15 wt.% of rhenium has improved radiopacity as compared to standard materials such as stainless steel or a cobalt-chromium alloy, reducing or eliminating the need to use a marker material in the medical device. For example, a refractory metal alloy or a metal alloy containing at least 15 wt.% of rhenium has a radiopacity that is at least about 10-20% higher than that of stainless steel or a cobalt-chromium alloy.

[0106] ● A refractory metal alloy or a metal alloy containing at least 15 wt.% of rhenium has improved fatigue ductility when cold-worked, as compared to cold-working of stainless steel, a chromium-cobalt alloy, or a titanium alloy.

[0107] ● A refractory metal alloy or a metal alloy containing at least 15 wt.% of rhenium has improved durability as compared to stainless steel, a chromium-cobalt alloy, or a titanium alloy.

[0108] ● A refractory metal alloy or a metal alloy containing at least 15 wt.% of rhenium has improved hydrophilicity as compared to stainless steel, a chromium-cobalt alloy, or a titanium alloy.

[0109] ● A refractory metal alloy or a metal alloy containing at least 15 wt.% of rhenium has reduced ion release in a body passage as compared to stainless steel, a chromium-cobalt alloy, or a titanium alloy.

[0110] ● A refractory metal alloy or metal alloy containing at least 15 wt.% rhenium is less irritating to the body than stainless steel, cobalt-chromium alloy, or titanium alloy, and thus can reduce inflammation, accelerate healing, and increase the success rate of medical devices. When a medical device is expanded in a body passage, minor damage may occur inside the passage. When the body begins to heal such minor damage, the body has a lower adverse reaction to the presence of a refractory metal alloy or metal alloy containing at least 15 wt.% rhenium compared to other metals such as stainless steel, cobalt-chromium alloy, or titanium alloy.

[0111] ● A refractory metal alloy or metal alloy containing at least 15 wt.% rhenium has a lower magnetic susceptibility than CoCr alloy, TiAlV alloy, and / or stainless steel, and thus, when a patient is subjected to an MRI or other medical device that generates a strong magnetic field, the incidence of potential defects in the medical device or complications to the patent after implantation of the medical device is reduced.

[0112] One non-limiting objective of the present disclosure is to provide a refractory metal alloy or metal alloy containing at least 15 wt.% rhenium according to the present disclosure that can be used to partially or completely form a medical device.

[0113] Another and / or alternative non-limiting objective of the present disclosure is to provide a medical device that is partially or completely formed from a refractory metal alloy or metal alloy containing at least 15 wt.% rhenium according to the present disclosure, and the medical device improves the surgical success rate.

[0114] Another and / or alternative non-limiting objective of the present disclosure is to provide a method and process for forming a refractory metal alloy or metal alloy containing at least 15 wt.% rhenium according to the present disclosure that inhibits or prevents the formation of microcracks during the processing of the refractory metal alloy or metal alloy containing at least 15 wt.% rhenium.

[0115] Another and / or alternative non-limiting objective of the present disclosure is to provide a medical device that is partially or completely formed from a refractory metal alloy or a metal alloy containing at least 15 wt.% rhenium according to the present disclosure, and the medical device has improved physical properties.

[0116] Another and / or alternative non-limiting objective of the present disclosure is to provide a medical device that is at least partially formed from a refractory metal alloy or a metal alloy containing at least 15 wt.% rhenium according to the present disclosure, and the medical device has increased strength and / or hardness.

[0117] Another and / or alternative non-limiting objective of the present disclosure is to provide a medical device that at least partially includes a refractory metal alloy or a metal alloy containing at least 15 wt.% rhenium according to the present disclosure, and the refractory metal alloy or the metal alloy containing at least 15 wt.% rhenium enables the medical device to be formed with less material without sacrificing the strength of the medical device as compared with conventional medical devices.

[0118] Another and / or alternative non-limiting objective of the present disclosure is to provide a method and process for forming a refractory metal alloy or a metal alloy containing at least 15 wt.% rhenium according to the present disclosure, which inhibits or prevents the formation of microcracks during the processing of the refractory metal alloy or the metal alloy containing at least 15 wt.% rhenium in a medical device.

[0119] Another and / or alternative non-limiting objective of the present disclosure is to provide a method and process for forming a refractory metal alloy or a metal alloy containing at least 15 wt.% rhenium according to the present disclosure, which inhibits or prevents crack propagation and / or fatigue failure of the refractory metal alloy or the metal alloy containing at least 15 wt.% rhenium.

[0120] Another and / or alternative non-limiting objective of the present disclosure is to provide a medical device comprising a refractory metal alloy or a metal alloy containing at least 15 wt.% rhenium and having a nitriding process for forming a nitride layer on the outer surface of the refractory metal alloy or the metal alloy containing at least 15 wt.% rhenium.

[0121] Another and / or alternative non-limiting objective of the present disclosure is to provide a medical device comprising a refractory metal alloy or a metal alloy containing at least 15 wt.% rhenium, and the refractory metal alloy or the metal alloy containing at least 15 wt.% rhenium is subjected to a swaging process.

[0122] Another and / or alternative non-limiting objective of the present disclosure is to provide a medical device comprising a refractory metal alloy or a metal alloy containing at least 15 wt.% rhenium, and the refractory metal alloy or the metal alloy containing at least 15 wt.% rhenium is subjected to a cold working process.

[0123] Another and / or alternative non-limiting objective of the present disclosure is to provide a medical device comprising a refractory metal alloy or a metal alloy containing at least 15 wt.% rhenium, which has increased strength and / or hardness compared to stainless steel, a chromium-cobalt alloy, or a titanium alloy.

[0124] Another and / or alternative non-limiting objective of the present disclosure is to provide a medical device comprising a refractory metal alloy or a metal alloy containing at least 15 wt.% rhenium, whereby in order to achieve a similar strength compared to a medical device formed from a different metal, a smaller amount of the refractory metal alloy or the metal alloy containing at least 15 wt.% rhenium is required.

[0125] Another and / or alternative non-limiting objective of the present disclosure is to provide a medical device comprising a refractory metal alloy or a metal alloy containing at least 15 wt.% rhenium, wherein at least a portion of the medical device is configured to be crimped and / or expanded (e.g., a stent, a frame of a heart valve, etc.), and the medical device has a smaller crimped profile compared to a medical device formed from different metals.

[0126] Another and / or alternative non-limiting objective of the present disclosure is to provide a medical device comprising a refractory metal alloy or a metal alloy containing at least 15 wt.% rhenium, wherein at least a portion of the medical device is configured to be crimped and / or expanded (e.g., a stent, a frame of a heart valve, etc.), the medical device has thinner walls and / or struts than within a frame of the same shape formed from stainless steel, cobalt and chromium alloys or titanium alloys, and such a frame formed from a refractory metal alloy or a metal alloy containing at least 15 wt.% rhenium has the same or increased radial strength when the frame is expanded from a crimped configuration to an expanded configuration compared to such a frame formed from stainless steel or cobalt and chromium alloys, or titanium alloys.

[0127] Another and / or alternative non-limiting objective of the present disclosure is to provide a medical device comprising a refractory metal alloy or a metal alloy containing at least 15 wt.% rhenium, and the medical device has improved stress-strain characteristics, bending characteristics, elongation characteristics, and / or flexibility or bending characteristics compared to a medical device formed from stainless steel, titanium alloy, or chromium-cobalt alloy.

[0128] Another and / or alternative non-limiting objective of the present disclosure is to provide a medical device comprising a refractory metal alloy or a metal alloy containing at least 15 wt.% rhenium, and the medical device has an extended lifespan compared to a medical device formed from stainless steel, titanium alloy, or chromium-cobalt alloy.

[0129] Another and / or alternative non-limiting objective of the present disclosure is to provide a medical device comprising a refractory metal alloy or a metal alloy containing at least 15 wt.% of rhenium, wherein at least a portion of the medical device is configured to be crimped and / or expanded (e.g., a stent, a frame of a heart valve, etc.), and the medical device has a reduced degree of reaction during crimping and / or expansion of the medical device as compared to a frame of similar size, shape, and configuration formed from stainless steel, a chromium-cobalt alloy, or a titanium alloy.

[0130] Another and / or alternative non-limiting objective of the present disclosure is to provide a medical device comprising a refractory metal alloy or a metal alloy containing at least 15 wt.% of rhenium, and the medical device conforms better to an irregularly shaped body passage when expanded within the body passage as compared to a frame of similar size, shape, and configuration formed from stainless steel, a chromium-cobalt alloy, or a titanium alloy.

[0131] Another and / or alternative non-limiting objective of the present disclosure is to provide a medical device comprising a refractory metal alloy or a metal alloy containing at least 15 wt.% of rhenium, and the medical device has improved fatigue ductility when subjected to cold working as compared to cold working of a frame of similar size, shape, and configuration formed from stainless steel, a chromium-cobalt alloy, or a titanium alloy.

[0132] Another and / or alternative non-limiting objective of the present disclosure is to provide a medical device comprising a refractory metal alloy or a metal alloy containing at least 15 wt.% of rhenium, and the medical device has improved durability as compared to stainless steel, a chromium-cobalt alloy, or a titanium alloy.

[0133] Another and / or alternative non-limiting objective of the present disclosure is to provide a medical device comprising a refractory metal alloy or a metal alloy containing at least 15 wt.% of rhenium, and the medical device has improved hydrophilicity as compared to stainless steel, a chromium-cobalt alloy, or a titanium alloy.

[0134] Another and / or alternative non-limiting objective of the present disclosure is to provide a medical device comprising a refractory metal alloy or a metal alloy containing at least 15 wt.% rhenium, wherein the medical device has reduced ion release within a body passage as compared to stainless steel, a chromium-cobalt alloy, or a titanium alloy.

[0135] Another and / or alternative non-limiting objective of the present disclosure is to provide a medical device comprising a refractory metal alloy or a metal alloy containing at least 15 wt.% rhenium, wherein the medical device has fewer irritants to the body than stainless steel, a cobalt-chromium alloy, or a titanium alloy, and thus can result in reduced inflammation, accelerated healing, and increased success rate of the medical device.

[0136] Another and / or alternative non-limiting objective of the present disclosure is to provide a medical device comprising a refractory metal alloy or a metal alloy containing at least 15 wt.% rhenium, wherein the medical device is subjected to a final heat treatment process along a part or all of the longitudinal length of the metal alloy.

[0137] Another and / or alternative non-limiting objective of the present disclosure is to provide a medical device comprising a refractory metal alloy or a metal alloy containing at least 15 wt.% rhenium, wherein the medical device is subjected to a final heat treatment process along a part or all of the longitudinal length of the metal alloy in order to soften the metal alloy (e.g., increase flexibility, increase bendability, reduce yield strength and / or ultimate tensile strength).

[0138] Another and / or alternative non-limiting objective of the present disclosure is to provide a medical device comprising a refractory metal alloy or a metal alloy containing at least 15 wt.% rhenium, wherein the medical device is subjected to a final heat treatment process along a part or all of the longitudinal length of the metal alloy in order to soften the metal alloy, and the metal alloy is not subjected to quenching after the final heat treatment process.

[0139] Another and / or alternative non-limiting objective of the present disclosure is to provide a medical device comprising a refractory metal alloy or a metal alloy containing at least 15 wt.% rhenium, the medical device being subjected to a final heat treatment process and then cooled by simply exposing it to the ambient temperature of the atmosphere surrounding the heated metal alloy (e.g., 55 - 95°F and all values and ranges therebetween, such as 70 - 80°F), and the cooling can optionally be carried out in a non-oxidizing gas environment, an inert gas environment, a partial or complete vacuum [e.g., 0 - 0.5 atm.], etc.).

[0140] Another and / or alternative non-limiting objective of the present disclosure is to provide a medical device comprising a refractory metal alloy or a metal alloy containing at least 15 wt.% rhenium, the medical device being subjected to a final heat treatment process along a portion of the longitudinal length of the metal alloy, and a heat insulation device is used to prevent another portion of the piece of the metal alloy from being subjected to the final heat treatment.

[0141] Another and / or alternative non-limiting objective of the present disclosure is to provide a rod or a strut having different degrees of flexibility or bendability but having the same cross-sectional size and shape along the longitudinal length of the rod or the strut.

[0142] Another and / or alternative non-limiting objective of the present disclosure is to provide a rod or a strut having different degrees of flexibility or bendability but having the same cross-sectional size and shape along the longitudinal length of the rod or the strut, and the rod or the strut can be color-coded (e.g., color coating, etc.) or can have other or additional markings to indicate the flexibility or bendability of the rod or the strut.

[0143] Another and / or alternative non-limiting objective of the present disclosure is to provide a plurality of devices (e.g., medical devices [e.g., spinal rods, spinal screws (e.g., pedicle screws), spinal struts, etc.], medical tools, etc.) that are a) formed from the same metal alloy (e.g., refractory metal alloy [e.g., MoRe alloy, Re alloy, Mo alloy, Ta alloy, W alloy, etc.], metal alloy containing at least 15 wt.% rhenium, etc.), b) of exactly the same size, shape, and configuration, or have similar sizes, shapes, and configurations (e.g., the devices have exactly the same size, shape, and configuration along 40 to 100% [and all values and ranges therebetween] of the longitudinal length of the device), c) having different physical properties with respect to at least flexibility or bendability, yield strength, and / or ultimate tensile strength, at least partially due to subjecting the metal alloy on the plurality of devices to different final heating processes, and d) optionally having one or more markings (e.g., color coating, etching on the outer surface, symbols on the outer surface, etc.) used to visually indicate the properties or relative properties of the plurality of devices.

[0144] Another and / or alternative non-limiting objective of the present disclosure is a method for using a medical device in the form of a spinal rod or spinal strut in a spinal surgical procedure, comprising: a) i) the same metal alloy (e.g., refractory metal alloy [e.g., MoRe alloy, Re alloy, Mo alloy, Ta alloy, W alloy, etc.], at least 15 wt%formed from a metal alloy containing [[ID=]], ii) generally cylindrical, having a body member with a constant cross-sectional shape and a diameter of cross-sectional size along 60 to 100% (and all values and ranges therebetween) of the longitudinal length of the body member, iii) the body members of the plurality of spinal rods or spinal struts have different physical properties with respect to at least flexibility or bendability, yield strength, and / or ultimate tensile strength, at least in part due to subjecting the metal alloy on the body portions of the plurality of spinal rods or spinal struts to different final heating processes, iv) providing a plurality of spinal rods or spinal struts, wherein the spinal rod or spinal strut optionally has one or more markings (e.g., color coating, etching on the outer surface, symbols on the outer surface, etc.) used to visually indicate one or more properties or relative properties of the spinal rod or spinal strut, b) identifying the positions at which the plurality of spinal rods or spinal struts are used in a spinal surgical procedure, c) determining the desired flexibility or bendability of each spinal rod or strut used at a particular position of the spine during a spinal surgical procedure, d) selecting a spinal rod or strut having the desired flexibility or bendability (and such selection is optionally based on the markings of the spinal rod or spinal strut), e) selecting spinal pedicle screws (e.g., pedicle screws) for use in a spinal procedure, each of the spinal pedicle screws including an upper portion having a strut opening configured to receive a portion of the spinal rod or spinal strut, such that the spinal rod or spinal strut can be fixed to the strut opening, thereby fixing the spinal rod or spinal strut to the upper portion of the spinal pedicle screw, and the shape, size, and configuration of the posting perforations for all of the plurality of spinal pedicle screws being the same, f) inserting two or more spinal pedicle screws into a patient's bone (e.g., the spine, etc.), g) fixing a selected spinal rod or spinal strut having the desired flexibility or bendability to the spinal pedicle screws during a spinal surgical procedure.

[0145] Another and / or alternative non-limiting objective of the present disclosure is a method of providing spinal fusion components to a healthcare provider or healthcare system, comprising: a) providing a plurality of spinal screws or pedicle screws, each spinal screw including a body portion configured to be inserted into the spine and a head portion connected to the body portion, the head portion being configured to include a strut opening and a fixing device, the longitudinal length of the body portion being 20 to 80 mm (and all values and ranges therebetween), the strut opening being designed to allow a portion of a spinal rod or strut to be inserted therein, the configuration of the strut opening being the same as that of the spinal screw regardless of the longitudinal length of the body, and the fixing device being designed to fix a spinal rod or spinal strut to the strut opening; b) providing a plurality of spinal rods or spinal struts, wherein i) the spinal rods or spinal struts are formed from the same metal alloy (e.g., a refractory metal alloy [e.g., MoRe alloy, Re alloy, Mo alloy, Ta alloy, W alloy, etc.], a metal alloy containing at least 15 wt.% rhenium, etc.), ii) generally cylindrical, having a diameter with a constant cross-sectional shape and cross-sectional size along 60 to 100% (and all values and ranges therebetween) of the longitudinal length of the body member, iii) the body members of the plurality of spinal rods or spinal struts have different physical properties with respect to at least flexibility or bendability, yield strength, and / or ultimate tensile strength, at least partially due to subjecting the metal alloy on the body portions of the plurality of spinal rods or spinal struts to different final heating processes, and iv) the spinal rod or spinal strut optionally has one or more markings (e.g., a color coating, an etching on the outer surface, a symbol on the outer surface, etc.) used to visually indicate one or more or all of the properties or relative properties of the spinal rod or spinal strut; c) enabling a healthcare provider or healthcare system to use a plurality of spinal screws provided for use in a specific medical procedure; and d) enabling a healthcare provider or healthcare system to use one or more of the spinal rods or struts provided for use in a specific medical procedure, wherein the obtained spinal rod or spinal strut appropriately fits into and is fixed to the opening of the spinal screw.

[0146] Another and / or alternative non-limiting objective of the present disclosure is to provide a medical device that is at least partially formed from a refractory metal alloy or a metal alloy containing at least 15 wt.% rhenium, which overcomes some unmet needs present in equivalent medical devices formed from CoCr alloys, TiAlV alloys, and stainless steels. The unmet needs are, namely, 1) eliminating the need to create large holes in large arterial or other blood vessels to initially insert a coiled medical device into an atrial or other blood vessel, thereby reducing the incidence of life-threatening bleeding during treatment; 2) creating a medical device (e.g., a stent, an artificial heart valve, etc.) having a reduced coiled profile that is smaller than medical devices formed from CoCr alloys, TiAlV alloys, and stainless steels, such that the medical device can be delivered and implanted through an abnormally shaped heart valve or an abnormally shaped arterial blood vessel for the firing of the medical device and / or the arterial blood vessel and / or plaque; 3) better conforming to the shape of an abnormally shaped heart valve opening upon expansion of the medical device, compared to conventional medical devices formed from CoCr alloys, TiAlV alloys, and stainless steels, with at least 15 wt.By using a frame formed from a refractory metal alloy or a metal alloy containing

[0147] These and other advantages will be apparent to those skilled in the art upon reading and following this description.

[0148] ​Reference may now be made to the drawings, which show various non-limiting embodiments in which the present disclosure may take physical form and in particular parts and arrangements thereof.

Brief Description of the Drawings

[0149]

Figure 1

Figure 2

Figure 3

Figure 4A

Figure 4B

Figure 4C

Figure 5

Figure 6

Figure 7

Figure 8

Figure 9

Figure 10

Figure 11

Figure 12

Figure 13

Mode for Carrying Out the Invention

[0150] In the following description, specific terms are used for clarity, but these terms are intended to refer only to the specific structures of the embodiments selected for illustration in the drawings and are not intended to define or limit the scope of the present disclosure. It should be understood that in the drawings and the following description, like reference numerals refer to components of like function.

[0151] The singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise.

[0152] As used in this specification and the claims, the term "comprising" may include embodiments of "consisting of" and "consisting essentially of". As used herein, the terms "comprise", "include", "having", "has", "can", "contain", and variations thereof are non-limiting transitional phrases, terms, or words that require the presence of the specified component / step and allow the presence of other components / steps. However, such descriptions should be construed as describing the composition or process as "consisting of" the recited components / steps and "consisting essentially of" the recited components / steps, which allows only the presence of the specified components / steps, together with any unavoidable impurities that may result therefrom, and excludes other components / steps.

[0153] In the specification and claims of this application, numerical values should be understood to include values that are the same when reduced to the same number of significant figures and values that differ from the numerical values in the application by less than the experimental error of conventional measurement techniques of the type described in the application for determining the value.

[0154] All ranges disclosed in this specification include the recited endpoints and can be combined independently (e.g., the range "2 grams to 10 grams" includes the endpoints, 2 grams and 10 grams, and all intermediate values).

[0155] The terms "about" and "approximately" can be used to include any numerical value that can vary without changing the basic function of that value. When used with a range, "about" and "approximately" also disclose the range defined by the absolute values of the two endpoints; for example, "about 2 to about 4" also discloses the range "2 to 4". Generally, the terms "about" and "approximately" can refer to plus or minus 10% of the indicated number.

[0156] Percentages of elements should be considered to be weight percentages of the elements described unless otherwise explicitly stated.

[0157] The medical devices according to the present disclosure can be any medical device that can be inserted into a patient or applied in other ways. Non-limiting medical devices according to the present disclosure include orthopedic devices, PFO devices, stents, valves (e.g., heart valves, etc.), spinal implants, devices for treating aneurysms, occlusion devices for use in blood vessels and other body passages, blood flow regulation and / or diversion devices, devices for denuding the walls of aneurysms, frames and other structures for use in spinal implants, vascular implants, grafts, dental implants, wires for use in medical procedures, bone implants; artificial discs, artificial spinal discs, bone and / or cartilage, bone plates, artificial implants or devices for repairing, replacing and / or supporting nails; rods, screws, struts; cages, plates, pedicle screws, joint systems, anchors, bone spacers, or, without limitation, discs used in the body, such as the human body, the body of an animal, etc., to support structures, attach structures, and / or repair structures within the body.

[0158] As discussed above, FIG. 1 shows a non-limiting process for subjecting a part or all of a medical device to a final heat treatment process so as to reduce the yield strength and / or ultimate tensile strength of a refractory metal alloy or metal alloy containing at least 15 wt.% rhenium subjected to the final heat treatment process. As shown in FIG. 1, the rod or strut subjected to the final heat treatment is shown to be 20 inches, but it will be understood that other rod or strut lengths can be used. Also, as shown in FIG. 1, the bottom of the rod or strut disposed within the heating oven is about 14 inches and the top of the rod or strut disposed outside the heating oven is about 6 inches, but it can be understood that more or less of the rod or strut can be disposed within the heating oven for the final heat treatment process. In one non-limiting configuration, the portion of the rod located within the heating oven is exposed to a temperature of up to 1000° C. (e.g., 100-1000° C. and all values and ranges therebetween). In one particular non-limiting configuration, the portion of the rod disposed within the furnace is first exposed to a temperature of 10-250° C. (and all values and ranges therebetween, 90-160° C.) (e.g., a preheating step), then the heat is increased to 500-1000° C. (and all values and ranges therebetween, 550-700° C.) over 0.5-10 hours (and all values and ranges therebetween, 1-3 hours), and then the heat within the heating oven is maintained at the maximum temperature for 1-15 hours (and all values and ranges therebetween, 2-10 hours).

[0159] Once the final heat treatment of the rod or strut is complete, the rod or strut can be removed from the heating oven and cooled slowly. Generally, the cooling rate after the final heat treatment step is less than 100° C. / second (e.g., less than 1-100° C. / second and all values and ranges therebetween), typically less than 50° C. / second, more typically less than 25° C. / second.

[0160] When the rod or strut is cooled, the rod or strut can then be cut to a desired length (e.g., 20 - 500 mm [and all values and ranges therebetween] having a diameter of 3 - 8 mm [and all values and ranges therebetween]). As can be understood, the cut portion of the rod or strut can be a) the rod or strut portion subjected to the final heating process, b) the rod or strut portion not subjected to the final heating process, or c) the rod or strut portion where a part was subjected to the final heating process and the part not subjected to the final heating process. The physical properties of the rod or strut portion can be a) uniform or substantially uniform along the longitudinal length of the rod or strut portion, or b) vary along the longitudinal length of the rod or strut portion.

[0161] As shown in FIG. 13, refractory metal alloys or metal alloys containing at least 15 wt.% rhenium such as MoRe alloys (e.g., 40 - 60 wt.% Re and 40 - 60 wt.% Mo) are subjected to different final heating processes where test rod 1 is not subjected to the final heating process and test rod 14 is subjected to the final heating process for the longest time. Test rods 2 - 13 are subjected to the final heating process gradually for a longer time. As shown in Table 1, when the rod or strut is subjected to the final heating process (the maximum temperature of each of the final heating processes was the same [e.g., 550 - 650 °C, 600 °C, etc.]) for a longer time, the force required to obtain a bending displacement of about 21.5% decreased. Thus, Table 1 shows that rods or struts formed from the same refractory metal alloy or metal alloy having the same cross-sectional shape and the same cross-sectional area and containing at least 15 wt.% rhenium can have different yield strengths and ultimate tensile strengths after subjecting the rods or struts to different final heating processes. None of the rods or struts shown in FIG. 13 were quenched after the final heating process. The rods or struts were cooled by exposing them to ambient temperature (e.g., 65°F - 85°F) while placed in a non-oxidizing environment.

[0162] The rods or struts have different physical properties, at least with respect to flexibility or bendability, yield strength and / or ultimate tensile strength, but have the same or similar size, shape and configuration, and are a non-limiting method for using a plurality of rods or struts formed from the same refractory metal alloy or metal alloy containing at least 15 wt.% rhenium in a medical procedure. This method comprises a) i) the same metal alloy (e.g., refractory metal alloy [e.g., MoRe alloy, Re alloy, Mo alloy, Ta alloy, W alloy, etc.], at least 15 wt.formed from a metal alloy containing [[ID=]], ii) generally cylindrical, having a body member with a constant cross-sectional shape and cross-sectional size or diameter along 60 to 100% (and all values and ranges therebetween) of the longitudinal length of the body member, iii) the body members of the plurality of spinal rods or spinal struts have different physical properties with respect to at least flexibility or bendability, yield strength, and / or ultimate tensile strength, at least in part due to subjecting the metal alloy on the body portions of the plurality of spinal rods or spinal struts to different final heating processes, iv) providing a plurality of spinal rods or spinal struts, wherein the spinal rod or spinal strut optionally has one or more markings (e.g., color coating, etching on the outer surface, symbols on the outer surface, etc.) used to visually indicate one or more properties or relative properties of the spinal rod or spinal strut; b) identifying the positions at which the plurality of spinal rods or spinal struts are used in a spinal surgical procedure; c) determining the desired flexibility or bendability of each spinal rod or strut used at a particular location of the spine during a spinal surgical procedure; d) selecting a spinal rod or strut having the desired flexibility or bendability (and such selection is optionally based on the markings of the spinal rod or spinal strut); e) selecting spinal screws (e.g., pedicle screws) for use in a spinal procedure, each of the spinal screws including an upper portion having a strut opening configured to receive a portion of the spinal rod or strut, such that the spinal rod or strut can be fixed to the strut opening, thereby fixing the spinal rod or strut to the upper portion of the spinal screw, and the shapes, sizes, and configurations of the posting bores for all of the plurality of spinal screws are the same; f) inserting two or more spinal screws into the patient's bone (e.g., spine, etc.); g) fixing a selected spinal rod or spinal strut having the desired flexibility or bendability to the spinal screw during a spinal surgical procedure.

[0163] Referring now to FIG. 2, when a medical device includes a frame (e.g., a stent, a heart valve frame, etc.) that can be expanded or crimped, and the frame is partially or completely formed from a refractory metal alloy or a metal alloy containing at least 15 wt.% rhenium, the amount of reaction of the frame after crimping or expansion of the frame can be less than the amount of reaction of a frame of the same size, shape, and configuration formed from a different metal such as a CoCr alloy or a Ti alloy. As shown in FIG. 2, the crimping or expansion of a frame formed from a CoCr alloy (e.g., 35Co-35Ni-20Cr-10Mo) reacts by 9% or more (e.g., 9 - 15% and all values and ranges therebetween) after the radial crimping force is removed from the frame. A frame formed from a Ti alloy (e.g., Ti-6Al-4V) reacts by 6% or more (e.g., 6 - 10% and all values and ranges therebetween) after the radial crimping force or expansion force is removed from the frame. A frame formed from a refractory metal alloy or a metal alloy (e.g., a MoRe alloy, etc.) containing at least 15 wt.% rhenium has a reaction of less than 2% when crimped or expanded, compared to a frame of the same shape, size, and configuration formed from a CoCr alloy or a Ti alloy. Although not shown in FIG. 2, a frame formed from stainless steel (e.g., 316, 316L) also reacts by 7% or more (e.g., 6 - 15% and all values and ranges therebetween) after the radial crimping force or expansion force is removed from the frame.

[0164] Due to the reaction of the frame formed from CoCr alloy, stainless steel or TiAlV alloy, the number of crimping cycles required to crimp a frame formed from a refractory metal alloy or metal alloy containing at least 15 wt.% rhenium is significantly less than the number of crimping cycles required to crimp a frame formed from stainless steel, CoCr or TiAlV. Typically, a frame formed from a refractory metal alloy or metal alloy containing at least 15 wt.% rhenium requires only one crimping cycle to obtain the desired crimp profile of the frame. Typically, a frame formed from stainless steel, CoCr or Ti alloy requires at least two, and generally more than three, crimping cycles to obtain the desired crimp profile of the frame. Due to such reaction of a frame formed from stainless steel, CoCr alloy or Ti alloy, the frame has to be repeatedly exposed to the crimping force in order to attempt to obtain the minimum crimp outer diameter of the crimped frame. The need to subject the frame to multiple crimping cycles or procedures can potentially result in damage to the frame and / or other components of the medical device (e.g., damage to the leaflets, skirt, balloon on the catheter, damage to one or more components on the catheter, etc.). Similarly, a frame formed from a refractory metal alloy or metal alloy containing at least 15 wt.% rhenium, such as a MoRe alloy, also has less reaction after expansion than a frame formed from stainless steel, CoCr or Ti alloy. Therefore, a frame formed from a refractory metal alloy or metal alloy containing at least 15 wt.% rhenium will better conform to the shape of the passage through which the frame is expanded. Further, a frame formed from a refractory metal alloy or metal alloy containing at least 15 wt.% rhenium expands from a single expansion of the balloon of the balloon delivery catheter to its desired expanded state. Due to the large reaction of the frame formed from CoCr alloy, stainless steel (e.g., 316, 316L), and Ti alloy after expansion, the balloon of the balloon delivery catheter typically has to be inflated multiple times to conform the frame to the shape of the cardiac passage through which the frame is expanded.Such multiple inflations of the balloon can result in an increased incidence of damage to body passages or components of the medical device (e.g., leaflets, skirts, etc.).

[0165] Figure 3 shows the increased compliance to bending of a wire, rod, or strut formed from a refractory metal alloy or metal alloy containing at least 15 wt.% rhenium, such as MoRe, compared to a wire, rod, or strut of the same shape, size, and configuration formed from a CoCr alloy. When the frame of a medical device is expanded, the struts and struts of the frame plastically deform (e.g., generally deform outwardly) due to the expansion of an inflatable balloon or some other expansion device. Generally, the treatment position where the medical device is expanded is not completely cylindrical and also does not have a completely circular cross-sectional shape. Generally, the treatment area is damaged and / or includes plaques, calcium deposits, and / or other materials (e.g., previously implanted medical devices, etc.) that make the shape of the treatment area non-cylindrical or have a non-circular cross-sectional shape. Thus, a frame that can better conform to the irregular shape of the treatment position results in a medical device that better conforms to the treatment area. Frames, wires, rods, struts, struts, etc. formed partially or completely from a refractory metal alloy or metal alloy containing at least 15 wt.% rhenium (e.g., MoRe alloy, etc.) are compared to frames, wires, rods, struts, struts, etc. of the same shape, size, and configuration formed partially or completely from metal alloys such as stainless steel, CoCr, nitinol, and TiAlV alloys, and stainless steel (e.g., 316, 316L), etc. It has been found that they better conform to the bending and / or shape of the passage through which the medical device is expanded. Figure 3 shows that when MoRe alloy wires and CoCr alloy wires of the same size, shape, and configuration are subjected to the same bending force, the MoRe alloy wires better conform to the ideal bending shape IBS than the CoCr alloy wires, i.e., the MoRe alloy wires better conform to the ideal bending shape by 23% to 31% better than the wires formed from CoCr alloy.It has been found that a wire formed from a refractory metal alloy or a metal alloy containing at least 15 wt.% rhenium (e.g., MoRe alloy, ReW alloy, MoReCr alloy, MoReTa alloy, MoReTi alloy, WCu alloy, ReCr alloy, Mo alloy, Re alloy, W alloy, Ta alloy, Nb alloy) conforms better to bending to an ideal bent shape by about 15 - 45% (as well as all values and ranges therebetween) than a wire of the same size, shape, and configuration formed from stainless steel, CoCr alloy, and TiAlV alloy.

[0166] Referring now to FIGS. 4A - 4C, there are three graphs showing stress versus percent reduction in area of wires formed from TiAlV alloy, CoCr alloy, and MoRe alloy, each wire having the same size, shape, and configuration. These three graphs show that a medical device partially or fully formed from frames, rods, struts, etc. made from a refractory metal alloy or a metal alloy containing at least 15 wt.% rhenium such as MoRe has improved properties such as strength, yield strength, ultimate tensile strength, fatigue ductility, a greater range of allowable deformation, integrity of the material between plastic deformation and fracture, and durability compared to a medical device of the same shape, size, and configuration partially or fully formed from frames, rods, struts, etc. made from materials such as CoCr alloy and TiAlV alloy. A medical device partially or fully formed from frames, rods, struts, etc. made from a refractory metal alloy or a metal alloy containing at least 15 wt.% rhenium such as MoRe can have a strength 1.5 - 5 times or more (as well as all values and ranges therebetween) greater than a medical device partially or fully formed from frames, rods, struts, etc. made from CoCr alloy, TiAlV alloy, and stainless steel (e.g., 316, 316L).

[0167] Referring now to FIG. 5, a medical device that is partially or completely formed from a refractory metal alloy or metal alloy containing at least 15 wt.% rhenium, such as a MoRe alloy, in the form of a frame, rod, strut, strut, etc., generally has greater rigidity and yield strength compared to a medical device that is partially or completely formed from a frame, rod, strut, strut, etc. made of CoCr alloy, TiAlV alloy, and stainless steel (e.g., 316, 316L). The upper curve in FIG. 5 is a MoRe alloy containing 47.5 wt.% Re and the balance Mo. The middle curve in FIG. 5 is a CoCr alloy containing 28 wt.% Cr, 6 wt.% Mo and the balance Co. The lower curve in FIG. 5 is a TiAlV alloy containing 6 wt.% Al, 4 wt.% V and the balance Ti. Although not shown, refractory metal alloys or metal alloys containing at least 15 wt.% rhenium, such as MoRe alloys, also generally have greater rigidity and yield strength compared to medical devices that are partially or completely formed from frames, rods, struts, struts, etc. made of stainless steel (e.g., 316, 316L, etc.).

[0168] Referring now to FIGS. 6-8, three graphs showing the yield strength, ultimate strength, and fatigue ductility of wires formed from TiAlV alloy, CoCr alloy, and MoRe alloy after such alloys have been cold worked to reduce the cross-sectional area of the alloy, the wires having the same size, shape, and configuration. After cold working, wires formed from refractory metal alloys or metal alloys containing at least 15 wt.% rhenium, such as MoRe alloys, generally have higher fatigue ductility, yield strength, and ultimate strength than wires of the same shape, size, and configuration formed from CoCr alloy, TiAlV alloy, and stainless steel (e.g., 316, 316L, etc.). Also, cold working of wires formed from refractory metal alloys or metal alloys containing at least 15 wt.% rhenium, such as MoRe alloys, results in an increase in the ductility of the wire. The graphs show the opposite effect on the ductility of wires formed from CoCr alloy, TiAlV alloy, and stainless steel (not shown) after the wires have been subjected to additional cold working.

[0169] Referring now to FIG. 9, the hydrophilicity of a wire formed from a refractory metal alloy or a metal alloy containing at least 15 wt.% rhenium, such as a MoRe alloy, is compared with that of a wire of the same shape, size, and configuration formed from a CoCr alloy or a TiAlV alloy. As shown in FIG. 9, the CoCr alloy is a hydrophobic material that results in a large contact angle (93° ± 1°) of water droplets (e.g., distilled water) disposed on the surface of a wire formed from the CoCr alloy. The TiAlV alloy is slightly more hydrophilic than the CoCr alloy and exhibits a contact angle of 58° ± 8° when water droplets are disposed on the surface of a wire formed from the Ti alloy. A refractory metal alloy or a metal alloy containing at least 15 wt.% rhenium, such as a MoRe alloy, has much higher hydrophilicity than the CoCr alloy or the TiAlV alloy. A wire formed from a MoRe alloy has a contact angle of 37° ± 3° when water droplets are disposed on the surface of the wire formed from the MoRe alloy. The surfaces of frames, wires, struts, struts, etc. formed from a refractory metal alloy or a metal alloy containing at least 15 wt.% rhenium generally have a hydrophilicity such that the contact angle of water droplets on the surfaces of such frames, wires, struts, struts, etc. is 25° to 45° (as well as all values and ranges therebetween), typically 30 to 42°.

[0170] Referring now to FIGS. 10 - 12, graphs and tables showing the ion release of a refractory metal alloy or a metal alloy containing at least 15 wt.% rhenium, such as a MoRe alloy, are shown. As shown in FIG. 10, during the first day of implanting a medical device containing frames, struts, struts, wires, etc. formed from a refractory metal alloy or a metal alloy containing at least 15 wt.% rhenium, such as a MoRe alloy (e.g., 40 - 60 wt.% Re and 40 - 60 wt.% Mo), the ion release of molybdenum is about 0.244 μg / cm per day 2 and the ion release of rhenium is about 0.115 μg / cm per day 2 From days 1 - 3, the ion release of molybdenum is about 0.019 μg / cm per day 2and the rhenium ion release is about 0.013 μg / cm per day. 2 From the 3rd to 7th day, the molybdenum ion release was 0.001 μg / cm per day. 2 and rhenium ion release is about 0.002 μg / cm per day. 2 From the 7th to 15th day, the molybdenum ion release was approximately 0.002 μg / cm per day. 2 and the rhenium ion release is 0.001 μg / cm per day. 2 From days 15 to 30, the ion release of Mo was approximately 0.003 μg / cm per day. 2 and the rhenium ion release is 0.001 μg / cm per day. 2 This graph shows that after 7 days of implantation in tissue, there was virtually no release of molybdenum and rhenium ions from the MoRe alloy.

[0171] Referring now to Figure 11, a graph shows that the ionic release of molybdenum from MoRe alloys (e.g., 40-60 wt% Re and 40-60 wt% Mo) in frames, struts, posts, wires, etc., implanted or otherwise inserted in a patient is less than 1.5% of the allowable daily exposure to molybdenum during the first day of insertion of the MoRe alloy in a patient, and after 15 days, such daily ionic exposure of molybdenum drops to 0.04% of the allowable daily exposure. Figure 11 also shows that the ionic release of rhenium from MoRe alloys in frames, struts, posts, wires, etc., implanted or otherwise inserted in a patient is less than 0.31% of the allowable daily exposure to rhenium during the first day of insertion of the MoRe alloy in a patient, and after 15 days, such daily ionic exposure of rhenium drops to less than 0.01% of the allowable daily exposure.

[0172] Referring now to Figure 12, a table is shown that indicates the amount of primary metals in TiAlV, CoCr, stainless steel, and MoRe alloys released into a patient after a medical device containing such an alloy was inserted into the patient for 90 days. The medical devices containing these allowances are of the same size, shape, and configuration. As shown in the table of Figure 12, the amounts of molybdenum and rhenium contained in the tissue surrounding the MoRe alloy after 90 days (e.g., 40 - 60 wt% Re and 40 - 60 wt% Mo) are significantly lower than any of the major metals of the other alloys. The amount of molybdenum metal ions in 1 gram of tissue from a 0.028 cm 2 / g dose of MoRe (e.g., 40 - 60 wt% Re and 40 - 60 wt% Mo) in the tissue after 90 days is 0.023 μg / g. Thus, the absolute increase in molybdenum metal ions with respect to the dose size of the MoRe alloy in the tissue was 0.82. The amount of rhenium metal ions in 1 gram of tissue from a 0.028 cm 2 / g dose of MoRe in the tissue after 90 days is 0.014 μg / g. Thus, the absolute increase in Re metal ions with respect to the dose size of the MoRe alloy in the tissue was 0.5. Based on the absolute increase in metal ions in the tissue with respect to the dose of the metal alloy in the tissue, the content of both molybdenum and rhenium in the tissue from the MoRe alloy after implanting the MoRe alloy in the tissue for 90 days is at least 120 times less than cobalt or chromium from the CoCr alloy and far less than the other primary metals of the other tested alloys. Generally, the absolute ion release of a refractory metal alloy or metal alloy containing at least 15 wt% rhenium with respect to the dose of a refractory metal alloy or metal alloy containing at least 15 wt% rhenium (e.g., primary is an element in the alloy that is at least 2 wt% of the alloy) after 90 days in the tissue is at least 120 times less than any of the primary components of TiAlV, CoCr, stainless steel alloys when a similar dose of these other alloys is implanted in the patient or inserted in some other way.

[0173] Accordingly, among the objects made clear from the foregoing description, the objects described above are efficiently achieved, and specific changes can be made to the described structure without departing from the spirit and scope of the present disclosure. Therefore, all matters contained in the above description and shown in the accompanying drawings are to be construed as illustrative and not in a limiting sense. The present disclosure has been described with reference to preferred embodiments and alternative embodiments. Modifications and variations will be apparent to those skilled in the art upon reading and understanding the detailed description of the present disclosure provided herein. The present disclosure intends to cover all such modifications and variations as long as they fall within the scope of the present disclosure. Also, it is to be understood that the following claims are intended to cover all general and specific features of the present disclosure described herein, as well as all descriptions of the scope of the present disclosure that may be said to fall therebetween as a matter of language.

[0174] (Appendix) (Appendix 1) A metal rod formed from a metal alloy, wherein the metal rod is a medical device or forms part of a medical device, and the metal rod has one or more different physical properties along the longitudinal length of the metal selected from the group consisting of a) different flexibility or bendability, b) different yield strengths, c) different ultimate tensile strengths, and d) different metal alloy crystal structures, and the one or more different physical properties of the metal rod along the longitudinal length of the metal rod are obtained at least in part by subjecting different portions of the metal rod to different final heat treatment processes, the different final heat treatment processes including I) subjecting the metal alloy to different final heat temperatures at different positions along the longitudinal length of the metal rod, II) exposing the metal alloy to the final heat temperature for different times at different positions along the longitudinal length of the metal rod, and / or III) cooling the metal rod at different cooling rates at different positions along the longitudinal length of the metal rod after the final heat treatment process.

[0175] (Appendix 2) The metal rod according to appendix 1, wherein the metal alloy contains at least 15 wt.% of rhenium.

[0176] (Appendix 3) The metal rod according to appendix 1, wherein the metal rod has a constant cross-sectional shape and size along 80% to 100% of the longitudinal length of the metal rod.

[0177] (Appendix 4) The metal rod according to appendix 1, wherein at least a part of the metal rod is not subjected to a quench process during the cooling of the metal rod.

[0178] (Appendix 5) A method for forming a metal rod having different physical properties along its longitudinal length, comprising: a) providing the metal rod, wherein the metal rod is formed from a metal alloy; b) subjecting different portions of the metal rod at different longitudinal positions of the metal rod to different final heat treatment processes along the longitudinal length of the metal rod such that the different portions have one or more different physical properties selected from the group consisting of a) different flexibility or bendability, b) different yield strengths, c) different ultimate tensile strengths, and d) different metal alloy crystal structures, wherein the different final heat treatment processes include I) subjecting the metal alloy to different final heat temperatures at different positions along the longitudinal length of the metal rod, II) exposing the metal alloy to the final heat temperature for different times at different positions along the longitudinal length of the metal rod, and / or III) cooling the metal rod after the final heat treatment process at different cooling rates at different positions along the longitudinal length of the metal rod; comprising: Method.

[0179] (Appendix 6) The method according to appendix 5, wherein the metal alloy contains at least 15 wt.% of rhenium.

[0180] (Appendix 7) The method according to Appendix 5, wherein the metal rod has a constant cross-sectional shape and size along 80% to 100% of the length of the metal rod in the longitudinal direction thereof.

[0181] (Appendix 8) The method according to Appendix 5, wherein at least a part of the metal rod is not subjected to a quench process during the cooling of the metal rod.

[0182] (Appendix 9) The method according to Appendix 5, wherein the maximum temperature of the final heat treatment is 500 to 1000 °C.

[0183] (Appendix 10) The method according to Appendix 5, wherein the metal rod is subjected to the final heat treatment process for about 0.5 to 25 hours.

[0184] (Appendix 11) The method according to Appendix 5, wherein the step of cooling cools the metal rod at a rate of less than 100 °C / second.

[0185] (Appendix 12) The method according to Appendix 5, wherein the step of subjecting the metal rod to a final heat treatment process includes: a) first, raising the temperature around the metal rod from a minimum temperature to a maximum temperature over a first pre-set time; and b) maintaining the maximum temperature around the metal rod for a second time.

[0186] (Appendix 13) The method according to Appendix 12, wherein the minimum temperature is 10 to 250 °C, the first time is 0.5 to 10 hours, and the second time is 0.01 to 15 hours.

[0187] (Appendix 14) The method according to Appendix 5, wherein the step of cooling is performed in: a) a non-oxidizing gas environment at a temperature of 10 to 100 °C, b) an inert gas environment at a temperature of 10 to 100 °C, or c) an atmospheric environment at a temperature of 10 to 100 °C.

[0188] (Appendix 15) The method according to Appendix 5, further comprising the step of marking the metal rod to indicate the degree of relative flexibility of the metal rod.

[0189] (Appendix 1) A metal rod formed from a metal alloy, wherein the metal rod is a medical device or forms part of a medical device, and the metal rod has one or more different physical properties along the longitudinal length of the metal selected from the group consisting of: a) different flexibility or bendability, b) different yield strengths, c) different ultimate tensile strengths, and d) different metal alloy crystal structures, and the one or more different physical properties of the metal rod along the longitudinal length of the metal rod are obtained at least in part by subjecting different portions of the metal rod to different final heat treatment processes, the different final heat treatment processes comprising: I) subjecting the metal alloy to different final heat temperatures at different positions along the longitudinal length of the metal rod; II) exposing the metal alloy to the final heat temperature for different times at different positions along the longitudinal length of the metal rod; and / or III) cooling the metal rod after the final heat treatment process at different cooling rates at different positions along the longitudinal length of the metal rod.

[0190] (Appendix 2) The metal rod according to Appendix 1, wherein the metal alloy comprises at least 15 wt.% rhenium.

[0191] (Appendix 3) The metal rod according to Appendix 1, wherein the metal rod has a constant cross-sectional shape and size along 80% to 100% of the longitudinal length of the metal rod.

[0192] (Appendix 4) The metal rod according to Appendix 1, wherein at least a portion of the metal rod is not subjected to a quench process during the cooling of the metal rod.

[0193] (Appendix 5) A method for forming a metal rod having different physical properties along the length in the longitudinal direction, a) providing the metal rod, wherein the metal rod is formed from a metal alloy; b) subjecting different portions of the metal rod at different longitudinal positions of the metal rod to different final heat treatment processes such that the different portions of the metal rod have one or more different physical properties selected from the group consisting of a) different flexibility or bendability, b) different yield strengths, c) different ultimate tensile strengths, and d) different metal alloy crystal structures, wherein the different final heat treatment processes include: I) subjecting the metal alloy to different final heat temperatures at different positions along the length in the longitudinal direction of the metal rod; II) exposing the metal alloy to the final heat temperature for different times at different positions along the length in the longitudinal direction of the metal rod; and / or III) cooling the metal rod after the final heat treatment process at different cooling rates at different positions along the length in the longitudinal direction of the metal rod; comprising: A method.

[0194] (Appendix 6) The method according to Appendix 5, wherein the metal alloy contains at least 15 wt.% of rhenium.

[0195] (Appendix 7) The method according to Appendix 5, wherein the metal rod has a constant cross-sectional shape and size along 80% to 100% of the length in the longitudinal direction of the metal rod.

[0196] (Appendix 8) The method according to Appendix 5, wherein at least a portion of the metal rod is not subjected to a quench process during the cooling of the metal rod.

[0197] (Appendix 9) The method according to appended note 5, wherein the maximum temperature of the final heat treatment is 500 to 1000 °C.

[0198] (Appended note 10) The method according to appended note 5, wherein the metal rod is subjected to the final heat treatment process for about 0.5 to 25 hours.

[0199] (Appended note 11) The method according to appended note 5, wherein the step of cooling cools the metal rod at a rate of less than 100 °C / second.

[0200] (Appended note 12) The method according to appended note 5, wherein the step of subjecting the metal rod to the final heat treatment process includes: a) first, raising the temperature around the metal rod from the lowest temperature to the highest temperature in a first pre-time; and b) maintaining the highest temperature around the metal rod for a second time.

[0201] (Appended note 13) The method according to appended note 12, wherein the lowest temperature is 10 to 250 °C, the first time is 0.5 to 10 hours, and the second time is 0.01 to 15 hours.

[0202] (Appended note 14) The method according to appended note 5, wherein the step of cooling is performed in: a) a non-oxidizing gas environment at a temperature of 10 to 100 °C, b) an inert gas environment at a temperature of 10 to 100 °C, or c) an atmospheric environment at a temperature of 10 to 100 °C.

[0203] (Appended note 15) The method according to appended note 5, further including the step of marking the metal rod to indicate the degree of relative flexibility of the metal rod.

[0204] (Appended note 16) A set of spinal surgery materials for use in spinal surgery, a. The first and second support rods, each of the first and second support rods having the same cross-sectional shape and size along the longitudinal length of the first and second support rods, the first support rod being different from the second support rod in that the first support rod and the second support rod are subjected to different I) final heat treatment times, II) temperatures during the final heat treatment, and / or III) different cooling rates, and thus having different flexibility, bendability, yield strength, and / or ultimate tensile strength, the first support rod including a visual marking of the first rod, the second support rod including a visual marking of the second rod, the visual markings of the first and second rods being different, the first and second support rods, b. The first and second bone screws, each of the first and second bone screws including a threaded lower body portion and an upper portion including a rod fixation arrangement, the body portion of each of the first and second bone screws being formed from the same material, the upper portion of each of the first and second bone screws being formed from the same material, the rod fixation arrangement in the upper portion of each of the first and second bone screws including a rod slot or rod opening having the same shape and size, the rod slot or rod opening on each of the first and second bone screws being configured to receive a portion of one of the first or second support rods, the rod slot or rod opening on each of the first and second bone screws having the same shape and size, the first and second bone screws, comprising A set of spinal surgery materials.

[0205] (Appendix 17) The set of spinal surgery materials according to Appendix 16, wherein the body portion of the first bone screw has a different shape, size, and / or longitudinal length from the second bone screw, the first bone screw including a visual marking of the first screw, the second bone screw including a visual marking of the second screw, the visual markings of the first and second screws being different.

[0206] (Appendix 18) Each of the first and second support rods is formed from a metal alloy, and the metal alloy is: a) stainless steel containing at least 15 wt.% rhenium; b) cobalt-chromium alloy containing at least 15 wt.% rhenium; c) TiNi alloy containing at least 15 wt.% rhenium; d) TiAlV alloy containing at least 15 wt.% rhenium; e) Al alloy containing at least 15 wt.% rhenium; f) Ni alloy containing at least 15 wt.% rhenium; g) Ti alloy containing at least 15 wt.% rhenium; h) W alloy containing at least 15 wt.% rhenium; i) Cu alloy containing at least 15 wt.% rhenium; j) beryllium-copper alloy containing at least 15 wt.% rhenium; k) containing at least 30 wt.% of one or more of niobium, tantalum, titanium, cobalt, chromium, zirconium or tungsten, and further at least 15 wt.% rhenium; l) containing at least 50 wt.% of one or more of niobium, tantalum, titanium, cobalt, chromium, zirconium or tungsten, and further 1 to 40 wt.% of one or more of aluminum, bismuth, calcium, carbon, cerium oxide, copper, gold, hafnium, iridium, iron, lanthanum, lanthanum oxide, lead, magnesium, manganese, nickel, osmium, platinum, rare earth metals, rhodium, ruthenium, silicon, silver, technetium, tin, titanium, tungsten, vanadium, yttrium, yttrium oxide, zinc, and zirconium oxide, and further at least 15 wt.% rhenium; m) at least 60 wt.% tungsten, at least 15 wt.% rhenium; n) at least 60 wt.% tungsten, at least 15 wt.% rhenium, and at least 1 wt.% molybdenum; o) at least 50 wt.% rhenium, at least 20 wt.% chromium, and 0.One or more of aluminum, bismuth, calcium, carbon, cerium oxide, chromium, cobalt, copper, gold, hafnium, iridium, iron, lanthanum, lanthanum oxide, lead, magnesium, manganese, molybdenum, nickel, niobium, osmium, platinum, rare earth metals, rhodium, ruthenium, silicon, silver, tantalum, technetium, tin, titanium, tungsten, vanadium, yttrium, yttrium oxide, zinc, zirconium, and zirconium oxide, in an amount of 1 to 80% by weight; p) titanium exceeding 50% by weight, niobium in an amount of 15 to 45% by weight, zirconium in an amount of 1 to 10% by weight, and tantalum in an amount of 1 to 15% by weight; q) titanium exceeding 50% by weight, niobium in an amount of 15 to 45% by weight, and 1 to 10% by weight; r) cobalt in an amount of 30 to 60% by weight, chromium in an amount of 10 to 30% by weight, iron in an amount of 5 to 20% by weight, nickel in an amount of 5 to 22% by weight, and molybdenum in an amount of 2 to 12% by weight; s) zirconium in an amount of 40 to 60% by weight, and molybdenum in an amount of 40 to 60% by weight; t) niobium in an amount of 90 to 99.5% by weight, and zirconium in an amount of 0.5 to 10% by weight; or u) niobium in an amount of 55 to 75% by weight, tantalum in an amount of 18 to 40% by weight, tungsten in an amount of 1 to 7% by weight, and zirconium in an amount of 0.5 to 4% by weight, a set of spinal surgery materials as described in Appendix 16.

[0207] (Appendix 19) The body portions of each of the first and second bone screws are formed from a metal alloy, and the metal alloy is a) stainless steel containing at least 15 wt.% rhenium, b) cobalt-chromium alloy containing at least 15 wt.% rhenium, c) TiNi alloy containing at least 15 wt.% rhenium, d) TiAlV alloy containing at least 15 wt.% rhenium, e) Al alloy containing at least 15 wt.% rhenium, f) Ni alloy containing at least 15 wt.% rhenium, g) Ti alloy containing at least 15 wt.% rhenium, h) W alloy containing at least 15 wt.% rhenium, i) Cu alloy containing at least 15 wt.% rhenium, j) beryllium-copper alloy containing at least 15 wt.% rhenium, k) containing at least 30 wt.% of one or more of niobium, tantalum, titanium, cobalt, chromium, zirconium or tungsten, and further at least 15 wt.% rhenium, l) containing at least 50 wt.% of one or more of niobium, tantalum, titanium, cobalt, chromium, zirconium or tungsten, and further 1 to 40 wt.% of one or more of aluminum, bismuth, calcium, carbon, cerium oxide, copper, gold, hafnium, iridium, iron, lanthanum, lanthanum oxide, lead, magnesium, manganese, nickel, osmium, platinum, rare earth metals, rhodium, ruthenium, silicon, silver, technetium, tin, titanium, tungsten, vanadium, yttrium, yttrium oxide, zinc, and zirconium oxide, and further at least 15 wt.% rhenium, m) at least 60 wt.% tungsten, at least 15 wt.% rhenium, n) at least 60 wt.% tungsten, at least 15 wt.% rhenium, and at least 1 wt.% molybdenum, o) at least 50 wt.% rhenium, at least 20 wt.% chromium, and 0.One or more of aluminum, bismuth, calcium, carbon, cerium oxide, chromium, cobalt, copper, gold, hafnium, iridium, iron, lanthanum, lanthanum oxide, lead, magnesium, manganese, molybdenum, nickel, niobium, osmium, platinum, rare earth metals, rhodium, ruthenium, silicon, silver, tantalum, technetium, tin, titanium, tungsten, vanadium, yttrium, yttrium oxide, zinc, zirconium, and zirconium oxide in an amount of 1 to 80% by weight, p) titanium in an amount exceeding 50% by weight, niobium in an amount of 15 to 45% by weight, zirconium in an amount of 1 to 10% by weight, and tantalum in an amount of 1 to 15% by weight, q) titanium in an amount exceeding 50% by weight, niobium in an amount of 15 to 45% by weight, and 1 to 10% by weight, r) cobalt in an amount of 30 to 60% by weight, chromium in an amount of 10 to 30% by weight, iron in an amount of 5 to 20% by weight, nickel in an amount of 5 to 22% by weight, and molybdenum in an amount of 2 to 12% by weight, s) zirconium in an amount of 40 to 60% by weight, and molybdenum in an amount of 40 to 60% by weight, t) niobium in an amount of 90 to 99.5% by weight, and zirconium in an amount of 0.5 to 10% by weight, or u) niobium in an amount of 55 to 75% by weight, tantalum in an amount of 18 to 40% by weight, tungsten in an amount of 1 to 7% by weight, and zirconium in an amount of 0.5 to 4% by weight, a set of spinal surgery materials as described in Appendix 16.

[0208] (Appendix 20) A method for using a set of spinal surgery materials for use in spinal surgery, a. Providing first and second support rods, each of the first and second support rods having the same cross-sectional shape and size along the longitudinal length of the first and second support rods, the first support rod being different from the second support rod in that the first support rod and the second support rod are subjected to different I) final heat treatment time, II) temperature during the final heat treatment, and / or III) cooling rate, so as to have different flexibility, bendability, yield strength, and / or ultimate tensile strength, the first support rod including a visual marking of the first rod, the second support rod including a visual marking of the second rod, and the visual markings of the first and second rods being different, providing; b. Providing first and second bone screws, each of the first and second bone screws including an upper portion including a threaded lower body portion and a rod fixation arrangement, the body portions of each of the first and second bone screws being formed from the same material, the upper portions of each of the first and second bone screws being formed from the same material, the rod fixation arrangement in the upper portion of each of the first and second bone screws including a rod slot or rod opening of the same shape and size, the rod slot or rod opening on each of the first and second bone screws being configured to receive a portion of one of the first or second support rods, and the rod slot or rod opening on each of the first and second bone screws having the same shape and size. c. Inserting the first bone screw into a first bone of a patient's vertebra. d. Inserting the second bone screw into a second bone of the patient's vertebra. e. Determining a desired flexibility of a support device connected to the first and second bone screws. f. Selecting either the first or second support rod to be used as the support device based on the flexibility of the first and second rods and the desired flexibility of the support device, wherein the surgeon can determine a difference in flexibility between the first and second support rods based on markings on the first and second rods. g. Fixing the selected first or second support rod to the rod fixation arrangement on the first and second bone screws. Including Method.

[0209] (Appendix 21) The body portion of the first bone screw has a shape, size, and / or longitudinal length different from that of the second bone screw, the first bone screw includes a visual marking of the first screw, the second bone screw includes a visual marking of the second screw, the visual markings of the first and second screws are different, and further, i) determining a desired shape, size, and / or longitudinal length of a screw for insertion into the first bone; ii) determining a desired shape, size, and / or longitudinal length of a screw for insertion into the second bone; and iii) selecting either the first or second bone screw to be inserted into the first bone based on the determined desired shape, size, and / or longitudinal length of the screw for insertion into the first bone, and then inserting the selected first or second bone screw into the first bone, wherein a surgeon can determine a difference in the shape, size, and / or longitudinal length between the first and second bone screws based on the markings of the first and second screws, a method according to appendix 20.

[0210] (Appendix 22) Each of the first and second support rods is formed from a metal alloy, and the metal alloy is: a) stainless steel containing at least 15 wt.% rhenium; b) cobalt-chromium alloy containing at least 15 wt.% rhenium; c) TiNi alloy containing at least 15 wt.% rhenium; d) TiAlV alloy containing at least 15 wt.% rhenium; e) Al alloy containing at least 15 wt.% rhenium; f) Ni alloy containing at least 15 wt.% rhenium; g) Ti alloy containing at least 15 wt.% rhenium; h) W alloy containing at least 15 wt.% rhenium; i) Cu alloy containing at least 15 wt.% rhenium; j) beryllium-copper alloy containing at least 15 wt.% rhenium; k) containing at least 30 wt.% of one or more of niobium, tantalum, titanium, cobalt, chromium, zirconium or tungsten, and further at least 15 wt.% rhenium; l) containing at least 50 wt.% of one or more of niobium, tantalum, titanium, cobalt, chromium, zirconium or tungsten, and further 1 - 40 wt.% of one or more of aluminum, bismuth, calcium, carbon, cerium oxide, copper, gold, hafnium, iridium, iron, lanthanum, lanthanum oxide, lead, magnesium, manganese, nickel, osmium, platinum, rare earth metals, rhodium, ruthenium, silicon, silver, technetium, tin, titanium, tungsten, vanadium, yttrium, yttrium oxide, zinc, and zirconium oxide, and further at least 15 wt.% rhenium; m) at least 60 wt.% tungsten, at least 15 wt.% rhenium; n) at least 60 wt.% tungsten, at least 15 wt.% rhenium, and at least 1 wt.% molybdenum; o) at least 50 wt.% rhenium, at least 20 wt.% chromium, and 0.One or more of aluminum, bismuth, calcium, carbon, cerium oxide, chromium, cobalt, copper, gold, hafnium, iridium, iron, lanthanum, lanthanum oxide, lead, magnesium, manganese, molybdenum, nickel, niobium, osmium, platinum, rare earth metals, rhodium, ruthenium, silicon, silver, tantalum, technetium, tin, titanium, tungsten, vanadium, yttrium, yttrium oxide, zinc, zirconium, and zirconium oxide, in an amount of 1 to 80% by weight; p) titanium in an amount exceeding 50% by weight, niobium in an amount of 15 to 45% by weight, zirconium in an amount of 1 to 10% by weight, and tantalum in an amount of 1 to 15% by weight; q) titanium in an amount exceeding 50% by weight, niobium in an amount of 15 to 45% by weight, and 1 to 10% by weight; r) cobalt in an amount of 30 to 60% by weight, chromium in an amount of 10 to 30% by weight, iron in an amount of 5 to 20% by weight, nickel in an amount of 5 to 22% by weight, and molybdenum in an amount of 2 to 12% by weight; s) zirconium in an amount of 40 to 60% by weight, and molybdenum in an amount of 40 to 60% by weight; t) niobium in an amount of 90 to 99.5% by weight, and zirconium in an amount of 0.5 to 10% by weight; or u) niobium in an amount of 55 to 75% by weight, tantalum in an amount of 18 to 40% by weight, tungsten in an amount of 1 to 7% by weight, and zirconium in an amount of 0.5 to 4% by weight, the method according to Appendix 20.

[0211] (Appendix 23) The body portions of each of the first and second bone screws are formed from a metal alloy, and the metal alloy is: a) stainless steel containing at least 15 wt.% rhenium; b) cobalt-chromium alloy containing at least 15 wt.% rhenium; c) TiNi alloy containing at least 15 wt.% rhenium; d) TiAlV alloy containing at least 15 wt.% rhenium; e) Al alloy containing at least 15 wt.% rhenium; f) Ni alloy containing at least 15 wt.% rhenium; g) Ti alloy containing at least 15 wt.% rhenium; h) W alloy containing at least 15 wt.% rhenium; i) Cu alloy containing at least 15 wt.% rhenium; j) beryllium-copper alloy containing at least 15 wt.% rhenium; k) containing at least 30 wt.% of one or more of niobium, tantalum, titanium, cobalt, chromium, zirconium or tungsten, and further at least 15 wt.% rhenium; l) containing at least 50 wt.% of one or more of niobium, tantalum, titanium, cobalt, chromium, zirconium or tungsten, and further 1 to 40 wt.% of one or more of aluminum, bismuth, calcium, carbon, cerium oxide, copper, gold, hafnium, iridium, iron, lanthanum, lanthanum oxide, lead, magnesium, manganese, nickel, osmium, platinum, rare earth metals, rhodium, ruthenium, silicon, silver, technetium, tin, titanium, tungsten, vanadium, yttrium, yttrium oxide, zinc, and zirconium oxide, and further at least 15 wt.% rhenium; m) at least 60 wt.% tungsten, at least 15 wt.% rhenium; n) at least 60 wt.% tungsten, at least 15 wt.% rhenium, and at least 1 wt.% molybdenum; o) at least 50 wt.% rhenium, at least 20 wt.% chromium, and 0.One or more of aluminum, bismuth, calcium, carbon, cerium oxide, chromium, cobalt, copper, gold, hafnium, iridium, iron, lanthanum, lanthanum oxide, lead, magnesium, manganese, molybdenum, nickel, niobium, osmium, platinum, rare earth metals, rhodium, ruthenium, silicon, silver, tantalum, technetium, tin, titanium, tungsten, vanadium, yttrium, yttrium oxide, zinc, zirconium, and zirconium oxide in an amount of 1 to 80% by weight, p) titanium in an amount exceeding 50% by weight, niobium in an amount of 15 to 45% by weight, zirconium in an amount of 1 to 10% by weight, and tantalum in an amount of 1 to 15% by weight, q) titanium in an amount exceeding 50% by weight, niobium in an amount of 15 to 45% by weight, and 1 to 10% by weight, r) cobalt in an amount of 30 to 60% by weight, chromium in an amount of 10 to 30% by weight, iron in an amount of 5 to 20% by weight, nickel in an amount of 5 to 22% by weight, and molybdenum in an amount of 2 to 12% by weight, s) zirconium in an amount of 40 to 60% by weight, and molybdenum in an amount of 40 to 60% by weight, t) niobium in an amount of 90 to 99.5% by weight, and zirconium in an amount of 0.5 to 10% by weight, or u) niobium in an amount of 55 to 75% by weight, tantalum in an amount of 18 to 40% by weight, tungsten in an amount of 1 to 7% by weight, and zirconium in an amount of 0.5 to 4% by weight, the method according to appendix 20.

[0212] (Appendix 24) A method for forming a series of support rods that can be used in surgical procedures, a. Forming a first and a second rod, each of the first and second rods having the same cross-sectional shape and size along the longitudinal length of the first and second rods, each of the first and second rods being formed from a metal alloy, and the metal alloy used to form the first and second rods being the same, b. Subjecting the first metal rod to a final heat treatment process to change the flexibility of the metal alloy, change the bendability of the metal alloy, change the yield strength of the metal alloy, and / or change the ultimate tensile strength of the metal alloy on the first metal rod, c. subjecting the second metal rod to a final heat treatment process to change the flexibility of the metal alloy, change the bendability of the metal alloy, change the yield strength of the metal alloy, and / or change the ultimate tensile strength of the metal alloy in the first metal rod; d. cooling the first metal rod after the final heat treatment process; e. cooling the second metal rod after the final heat treatment process; f. applying a visual marking of the first rod to the first metal rod; g. applying a visual marking of the second rod to the second metal rod, including wherein the visual markings of the first and second rods are different; wherein the flexibility, bendability, yield strength, and / or ultimate tensile strength of the first metal rod is different from that of the second metal rod because the first metal rod and the second metal rod are subjected to different I) final heat treatment times, II) temperatures during the final heat treatment, and / or III) cooling rates.

[0213] (Appendix 25) The method according to Appendix 24, wherein the final heat treatment process of one or both of the first and second metal rods does not quench one or both of the first and second metal rods.

[0214] (Appendix 26) The metal alloy of each of the first and second support rods is a) stainless steel containing at least 15 wt.% rhenium, b) cobalt-chromium alloy containing at least 15 wt.% rhenium, c) TiNi alloy containing at least 15 wt.% rhenium, d) TiAlV alloy containing at least 15 wt.% rhenium, e) Al alloy containing at least 15 wt.% rhenium, f) Ni alloy containing at least 15 wt.% rhenium, g) Ti alloy containing at least 15 wt.% rhenium, h) W alloy containing at least 15 wt.% rhenium, i) Cu alloy containing at least 15 wt.% rhenium, j) beryllium-copper alloy containing at least 15 wt.% rhenium, k) containing at least 30 wt.% of one or more of niobium, tantalum, titanium, cobalt, chromium, zirconium or tungsten, and further at least 15 wt.% rhenium, l) containing at least 50 wt.% of one or more of niobium, tantalum, titanium, cobalt, chromium, zirconium or tungsten, and further 1 to 40 wt.% of one or more of aluminum, bismuth, calcium, carbon, cerium oxide, copper, gold, hafnium, iridium, iron, lanthanum, lanthanum oxide, lead, magnesium, manganese, nickel, osmium, platinum, rare earth metals, rhodium, ruthenium, silicon, silver, technetium, tin, titanium, tungsten, vanadium, yttrium, yttrium oxide, zinc, and zirconium oxide, and further at least 15 wt.% rhenium, m) at least 60 wt.% tungsten, at least 15 wt.% rhenium, n) at least 60 wt.% tungsten, at least 15 wt.% rhenium, and at least 1 wt.% molybdenum, o) at least 50 wt.% rhenium, at least 20 wt.% chromium, and 0.One or more of aluminum, bismuth, calcium, carbon, cerium oxide, chromium, cobalt, copper, gold, hafnium, iridium, iron, lanthanum, lanthanum oxide, lead, magnesium, manganese, molybdenum, nickel, niobium, osmium, platinum, rare earth metals, rhodium, ruthenium, silicon, silver, tantalum, technetium, tin, titanium, tungsten, vanadium, yttrium, yttrium oxide, zinc, zirconium, and zirconium oxide in an amount of 1 to 80% by weight, p) titanium exceeding 50% by weight, niobium in an amount of 15 to 45% by weight, zirconium in an amount of 1 to 10% by weight, and tantalum in an amount of 1 to 15% by weight, q) titanium exceeding 50% by weight, niobium in an amount of 15 to 45% by weight, and 1 to 10% by weight, r) cobalt in an amount of 30 to 60% by weight, chromium in an amount of 10 to 30% by weight, iron in an amount of 5 to 20% by weight, nickel in an amount of 5 to 22% by weight, and molybdenum in an amount of 2 to 12% by weight, s) zirconium in an amount of 40 to 60% by weight, and molybdenum in an amount of 40 to 60% by weight, t) niobium in an amount of 90 to 99.5% by weight, and zirconium in an amount of 0.5 to 10% by weight, or u) niobium in an amount of 55 to 75% by weight, tantalum in an amount of 18 to 40% by weight, tungsten in an amount of 1 to 7% by weight, and zirconium in an amount of 0.5 to 4% by weight, the method according to Appendix 24.

[0215] (Appendix 27) The method according to Appendix 24, wherein the maximum temperature of the final heat treatment, or one or both of the first and second metal rods, is 500 to 1000 °C.

[0216] (Appendix 28) The method according to Appendix 24, wherein one or both of the first and second metal rods are subjected to the final heat treatment process for about 0.5 to 25 hours.

[0217] (Appendix 29) The step of subjecting the first metal rod to a final heat treatment process includes: a) first, raising the temperature around the first metal rod from a minimum temperature to a maximum temperature for a first time; b) maintaining the maximum temperature around the first metal rod for a second time. The step of subjecting the second metal rod to a final heat treatment process includes: a) first, raising the temperature around the second metal rod from a minimum temperature to a maximum temperature for a first time; b) maintaining the maximum temperature around the second metal rod for a second time. The method according to Appendix 24.

[0218] (Appendix 30) The minimum temperature is 10 to 250 °C for one or both of the first and second metal rods, the first time is 0.5 to 10 hours for one or both of the first and second metal rods, the second time is 0.01 to 15 hours for one or both of the first and second metal rods, and the first time and / or the second time for the first metal rod is different from that of the second metal rod. The method according to Appendix 29.

[0219] (Appendix 31) One or both of the first and second metal rods are cooled at a rate of less than 100 °C / second during the cooling step. The method according to Appendix 24.

[0220] (Appendix 32) The cooling step is carried out in: a) a non-oxidizing gas environment at a temperature of 10 to 100 °C; b) an inert gas environment at a temperature of 10 to 100 °C; or c) an atmospheric environment at a temperature of 10 to 100 °C. The method according to Appendix 31.

Claims

1. A metal rod formed from a metal alloy, wherein the metal rod is a medical device or forms part of a medical device, and the metal rod has one or more different physical properties along the longitudinal length of the metal selected from the group consisting of: a) different flexibility or bendability, b) different yield strengths, c) different ultimate tensile strengths, and d) different metal alloy crystal structures, and the one or more different physical properties of the metal rod along the longitudinal length of the metal rod are obtained at least in part by subjecting different portions of the metal rod to different final heat treatment processes, the different final heat treatment processes comprising: I) subjecting the metal alloy to different final heat temperatures at different positions along the longitudinal length of the metal rod; II) exposing the metal alloy to the final heat temperature for different times at different positions along the longitudinal length of the metal rod; and / or III) cooling the metal rod at different cooling rates at different positions along the longitudinal length of the metal rod after the final heat treatment process.

2. The metal rod according to claim 1, wherein the metal alloy comprises at least 15 wt.% rhenium.

3. The metal rod according to claim 1, wherein the metal rod has a constant cross-sectional shape and size along 80% to 100% of the longitudinal length of the metal rod.

4. The metal rod according to claim 1, wherein at least a portion of the metal rod is not subjected to a quench process during the cooling of the metal rod.

5. A method for forming a metal rod having different physical properties along its longitudinal length, comprising: a) providing the metal rod, wherein the metal rod is formed from a metal alloy; b) subjecting different portions of the metal rod at different longitudinal positions thereof to different final heat treatment processes so that the different portions of the metal rod have one or more different physical properties selected from the group consisting of: a) different flexibility or bendability, b) different yield strengths, c) different ultimate tensile strengths, and d) different metal alloy crystal structures, said different final heat treatment processes comprising: I) subjecting the metal alloy to different final heat temperatures at different positions along the longitudinal length of the metal rod; II) exposing the metal alloy to the final heat temperature for different times at different positions along the longitudinal length of the metal rod; and / or III) cooling the metal rod after the final heat treatment process at different cooling rates at different positions along the longitudinal length of the metal rod, comprising, method. **Claim 6** The method according to claim 5, wherein the metal alloy comprises at least 15 wt. % rhenium. **Claim 7** The method according to claim 5, wherein the metal rod has a constant cross-sectional shape and size along 80% to 100% of the longitudinal length of the metal rod. **Claim 8** The method according to claim 5, wherein at least a portion of the metal rod is not subjected to a quench process during the cooling of the metal rod. **Claim 9** The method according to claim 5, wherein the maximum temperature of the final heat treatment is 500 to 1000 °C. **Claim 10** The method according to claim 5, wherein the metal rod is subjected to the final heat treatment process for about 0.5 to 25 hours. **Claim 11** The method according to claim 5, wherein the step of cooling cools the metal rod at a rate of less than 100 °C / second. **Claim 12** The method according to claim 5, wherein the step of subjecting the metal rod to the final heat treatment process comprises: a) first, raising the temperature around the metal rod from a minimum temperature to a maximum temperature for a first pre-time; and b) maintaining the maximum temperature around the metal rod for a second time. **Claim 13** The method according to claim 12, wherein the minimum temperature is 10 to 250 °C, the first time is 0.5 to 10 hours, and the second time is 0.01 to 15 hours. **Claim 14** The method according to claim 5, wherein the step of cooling is carried out in a) a non-oxidizing gas environment at a temperature of 10 to 100 °C, b) an inert gas environment at a temperature of 10 to 100 °C, or c) an atmospheric environment at a temperature of 10 to 100 °C.

15. The method according to claim 5, further comprising the step of marking the metal rod to indicate the degree of relative flexibility of the metal rod.

1. A metal rod formed from a metal alloy, wherein the metal rod is a medical device or forms part of a medical device, and the metal rod has one or more different physical properties along the longitudinal length of the metal selected from the group consisting of a) different flexibility or bendability, b) different yield strengths, c) different ultimate tensile strengths, and d) different metal alloy crystal structures, and the one or more different physical properties of the metal rod along the longitudinal length of the metal rod are obtained at least in part by subjecting different portions of the metal rod to different final heat treatment processes, the different final heat treatment processes comprising: I) subjecting the metal alloy to different final heat temperatures at different positions along the longitudinal length of the metal rod; II) exposing the metal alloy to the final heat temperature for different times at different positions along the longitudinal length of the metal rod; and / or III) cooling the metal rod after the final heat treatment process at different cooling rates at different positions along the longitudinal length of the metal rod.

2. The metal rod according to claim 1, wherein the metal alloy comprises at least 15 wt.% rhenium.

3. The metal rod according to claim 1, wherein the metal rod has a constant cross-sectional shape and size along 80% to 100% of the longitudinal length of the metal rod.

4. The metal rod according to claim 1, wherein at least a portion of the metal rod is not subjected to a quench process during the cooling of the metal rod.

5. A method for forming a metal rod having different physical properties along its longitudinal length, comprising: a) providing the metal rod, wherein the metal rod is formed from a metal alloy; b) Different portions of the metal rod at different longitudinal positions have one or more different physical properties selected from the group consisting of: a) different flexibility or bendability, b) different yield strengths, c) different ultimate tensile strengths, and d) different metal alloy crystal structures, such that different portions of the metal rod are subjected to different final heat treatment processes along the longitudinal length of the metal rod, wherein the different final heat treatment processes include: I) subjecting the metal alloy to different final heat temperatures at different positions along the longitudinal length of the metal rod; II) exposing the metal alloy to the final heat temperature for different times at different positions along the longitudinal length of the metal rod; and / or III) cooling the metal rod at different cooling rates at different positions along the longitudinal length of the metal rod after the final heat treatment process, the step comprising: Including: Method. **Claim 6** The method according to claim 5, wherein the metal alloy comprises at least 15 wt. % of rhenium. **Claim 7** The method according to claim 5, wherein the metal rod has a constant cross-sectional shape and size along 80% to 100% of the longitudinal length of the metal rod. **Claim 8** The method according to claim 5, wherein at least a portion of the metal rod is not subjected to a quench process during the cooling of the metal rod. **Claim 9** The method according to claim 5, wherein the maximum temperature of the final heat treatment is 500 to 1000 °C. **Claim 10** The method according to claim 5, wherein the metal rod is subjected to the final heat treatment process for about 0.5 to 25 hours. **Claim 11** The method according to claim 5, wherein the step of cooling cools the metal rod at a rate of less than 100 °C / second. **Claim 12** The step of subjecting the metal rod to a final heat treatment process includes: a) first, raising the temperature around the metal rod from a minimum temperature to a maximum temperature for a first pre-time; and b) maintaining the maximum temperature around the metal rod for a second time, the method according to claim 5. **Claim 13** The method according to claim 12, wherein the minimum temperature is 10 to 250 °C, the first time is 0.5 to 10 hours, and the second time is 0.01 to 15 hours. **Claim 14** The method according to claim 5, wherein the step of cooling is carried out in a) a non-oxidizing gas environment at a temperature of 10 to 100 °C, b) an inert gas environment at a temperature of 10 to 100 °C, or c) an atmospheric environment at a temperature of 10 to 100 °C.

15. The method according to claim 5, further comprising the step of marking the metal rod to indicate the degree of relative flexibility of the metal rod.

16. A set of spinal surgery materials for use in spinal surgery, a. First and second support rods, each of the first and second support rods having the same cross-sectional shape and size along the longitudinal length of the first and second support rods, the first support rod being different from the second support rod in that the first support rod and the second support rod are subjected to different I) final heat treatment times, II) temperatures during the final heat treatment, and / or III) different cooling rates, so that the first support rod has different flexibility, bendability, yield strength, and / or ultimate tensile strength from the second support rod, the first support rod including a visual marking of the first rod, the second support rod including a visual marking of the second rod, and the visual markings of the first and second rods being different, the first and second support rods; b. First and second bone screws, each of the first and second bone screws including a threaded lower body portion and an upper portion including a rod fixation arrangement, the body portions of each of the first and second bone screws being formed from the same material, the upper portions of each of the first and second bone screws being formed from the same material, the rod fixation arrangement in the upper portion of each of the first and second bone screws including a rod slot or rod opening having the same shape and size, the rod slot or rod opening on each of the first and second bone screws being configured to receive a portion of one of the first or second support rods, and the rod slot or rod opening on each of the first and second bone screws having the same shape and size, the first and second bone screws; comprising a set of spinal surgery materials.

17. The body portion of the first bone screw has a shape, size, and / or longitudinal length different from that of the second bone screw, the first bone screw includes a visual marking of the first screw, the second bone screw includes a visual marking of the second screw, and the visual markings of the first and second screws are different, the set of spinal surgery materials according to claim 16.

18. Each of the first and second support rods is formed from a metal alloy, and the metal alloy is a) stainless steel containing at least 15 wt. % rhenium, b) cobalt-chromium alloy containing at least 15 wt. % rhenium, c) TiNi alloy containing at least 15 wt. % rhenium, d) TiAlV alloy containing at least 15 wt. % rhenium, e) Al alloy containing at least 15 wt. % rhenium, f) Ni alloy containing at least 15 wt. % rhenium, g) Ti alloy containing at least 15 wt. % rhenium, h) W alloy containing at least 15 wt. % rhenium, i) Cu alloy containing at least 15 wt. % rhenium, j) beryllium-copper alloy containing at least 15 wt. % rhenium, k) containing one or more of niobium, tantalum, titanium, cobalt, chromium, zirconium or tungsten at least 30 wt. %, and further at least 15 wt. % rhenium, l) containing one or more of niobium, tantalum, titanium, cobalt, chromium, zirconium or tungsten at least 50 wt. %, and further 1 to 40 wt. % of aluminum, bismuth, calcium, carbon, cerium oxide, copper, gold, hafnium, iridium, iron, lanthanum, lanthanum oxide, lead, magnesium, manganese, nickel, osmium, platinum, rare earth metals, rhodium, ruthenium, silicon, silver, technetium, tin, titanium, tungsten, vanadium, yttrium, yttrium oxide, zinc, and zirconium oxide, and further at least 15 wt. % rhenium, m) at least 60 wt. % tungsten, at least 15 wt. % rhenium, n) at least 60 wt. % tungsten, at least 15 wt. % rhenium, and at least 1 wt. % molybdenum, o) at least 50 wt. % rhenium, at least 20 wt. % chromium, and 0.1 to 80 wt. % of aluminum, bismuth, calcium, carbon, cerium oxide, chromium, cobalt, copper, gold, hafnium, iridium, iron, lanthanum, lanthanum oxide, lead, magnesium, manganese, molybdenum, nickel, niobium, osmium, platinum, rare earth metals, rhodium, ruthenium, silicon, silver, tantalum, technetium, tin, titanium, tungsten, vanadium, yttrium, yttrium oxide, zinc, zirconium,and one or more of zirconium oxide, p) titanium in excess of 50% by weight, niobium from 15 to 45% by weight, zirconium from 1 to 10% by weight, and tantalum from 1 to 15% by weight, q) titanium in excess of 50% by weight, niobium from 15 to 45% by weight, and from 1 to 10% by weight, r) cobalt from 30 to 60% by weight, chromium from 10 to 30% by weight, iron from 5 to 20% by weight, nickel from 5 to 22% by weight, and molybdenum from 2 to 12% by weight, s) zirconium from 40 to 60% by weight, and molybdenum from 40 to 60% by weight, t) niobium from 90 to 99.5% by weight, and zirconium from 0.5 to 10% by weight, or u) niobium from 55 to 75% by weight, tantalum from 18 to 40% by weight, tungsten from 1 to 7% by weight, and zirconium from 0.5 to 4% by weight, the set of spinal surgery materials according to claim 16.,

19. The body portions of each of the first and second bone screws are formed from a metal alloy, and the metal alloy is a) stainless steel containing at least 15 wt. % rhenium, b) cobalt-chromium alloy containing at least 15 wt. % rhenium, c) TiNi alloy containing at least 15 wt. % rhenium, d) TiAlV alloy containing at least 15 wt. % rhenium, e) Al alloy containing at least 15 wt. % rhenium, f) Ni alloy containing at least 15 wt. % rhenium, g) Ti alloy containing at least 15 wt. % rhenium, h) W alloy containing at least 15 wt. % rhenium, i) Cu alloy containing at least 15 wt. % rhenium, j) beryllium-copper alloy containing at least 15 wt. % rhenium, k) containing one or more of niobium, tantalum, titanium, cobalt, chromium, zirconium or tungsten at least 30 wt. %, and further at least 15 wt. % rhenium, l) containing one or more of niobium, tantalum, titanium, cobalt, chromium, zirconium or tungsten at least 50 wt. %, and further 1 to 40 wt. % of aluminum, bismuth, calcium, carbon, cerium oxide, copper, gold, hafnium, iridium, iron, lanthanum, lanthanum oxide, lead, magnesium, manganese, nickel, osmium, platinum, rare earth metals, rhodium, ruthenium, silicon, silver, technetium, tin, titanium, tungsten, vanadium, yttrium, yttrium oxide, zinc, and zirconium oxide, and further at least 15 wt. % rhenium, m) at least 60 wt. % tungsten, at least 15 wt. % rhenium, n) at least 60 wt. % tungsten, at least 15 wt. % rhenium, and at least 1 wt. % molybdenum, o) at least 50 wt. % rhenium, at least 20 wt. % chromium, and 0.1 to 80 wt. % of aluminum, bismuth, calcium, carbon, cerium oxide, chromium, cobalt, copper, gold, hafnium, iridium, iron, lanthanum, lanthanum oxide, lead, magnesium, manganese, molybdenum, nickel, niobium, osmium, platinum, rare earth metals, rhodium, ruthenium, silicon, silver, tantalum, technetium, tin, titanium, tungsten, vanadium, yttrium, yttrium oxide, zinc,One or more of zirconium and zirconium oxide, p) titanium exceeding 50% by weight, niobium of 15 to 45% by weight, zirconium of 1 to 10% by weight, and tantalum of 1 to 15% by weight, q) titanium exceeding 50% by weight, niobium of 15 to 45% by weight, and 1 to 10% by weight, r) cobalt of 30 to 60% by weight, chromium of 10 to 30% by weight, iron of 5 to 20% by weight, nickel of 5 to 22% by weight, and molybdenum of 2 to 12% by weight, s) zirconium of 40 to 60% by weight, and molybdenum of 40 to 60% by weight, t) niobium of 90 to 99.5% by weight, and zirconium of 0.5 to 10% by weight, or u) niobium of 55 to 75% by weight, tantalum of 18 to 40% by weight, tungsten of 1 to 7% by weight, and zirconium of 0.5 to 4% by weight, a set of spinal surgery materials according to claim 16.,

20. A method for using a set of spinal surgery materials for use in spinal surgery, a. providing first and second support rods, each of the first and second support rods having the same cross-sectional shape and size along the longitudinal length of the first and second support rods, the first support rod being different from the second support rod in that the first support rod and the second support rod are subjected to different I) final heat treatment times, II) temperatures during the final heat treatment, and / or III) cooling rates, so as to have different flexibility, bendability, yield strength, and / or ultimate tensile strength, the first support rod including a visual marking of the first rod, the second support rod including a visual marking of the second rod, and the visual markings of the first and second rods being different; b. providing first and second bone screws, each of the first and second bone screws including a threaded lower body portion and an upper portion with a rod fixation arrangement, the body portion of each of the first and second bone screws being formed of the same material, the upper portion of each of the first and second bone screws being formed of the same material, the rod fixation arrangement in the upper portion of each of the first and second bone screws including a rod slot or rod opening of the same shape and size, the rod slot or rod opening on each of the first and second bone screws being configured to receive a portion of one of the first or second support rods, and the rod slot or rod opening on each of the first and second bone screws having the same shape and size; c. inserting the first bone screw into a first bone of a vertebra of a patient; d. inserting the second bone screw into a second bone of the vertebra of the patient; e. determining a desired flexibility of a support device connected to the first and second bone screws; f. Selecting either the first or the second support rod to be used as the support device based on the flexibility of the first and second rods and the desired flexibility of the support device, wherein the surgeon can determine the difference in flexibility between the first and second support rods based on the markings of the first and second rods; g. Fixing the selected first or second support rod to the rod fixation arrangement on the first and second bone screws; comprising; a method.

21. The body portion of the first bone screw has a different shape, size, and / or longitudinal length from the second bone screw, the first bone screw includes a visual marking of the first screw, the second bone screw includes a visual marking of the second screw, the visual markings of the first and second screws are different, and further, i) determining the desired shape, size, and / or longitudinal length of the screw for insertion into the first bone; ii) determining the desired shape, size, and / or longitudinal length of the screw for insertion into the second bone; iii) selecting either the first or the second bone screw to be inserted into the first bone based on the determined desired shape, size, and / or longitudinal length of the screw for insertion into the first bone, and then inserting the selected first or second bone screw into the first bone, wherein the surgeon can determine the difference in the shape, size, and / or longitudinal length between the first and second bone screws based on the markings of the first and second screws. The method according to claim 20.

22. Each of the first and second support rods is formed from a metal alloy, and the metal alloy is a) stainless steel containing at least 15 wt. % rhenium, b) cobalt-chromium alloy containing at least 15 wt. % rhenium, c) TiNi alloy containing at least 15 wt. % rhenium, d) TiAlV alloy containing at least 15 wt. % rhenium, e) Al alloy containing at least 15 wt. % rhenium, f) Ni alloy containing at least 15 wt. % rhenium, g) Ti alloy containing at least 15 wt. % rhenium, h) W alloy containing at least 15 wt. % rhenium, i) Cu alloy containing at least 15 wt. % rhenium, j) beryllium-copper alloy containing at least 15 wt. % rhenium, k) containing one or more of niobium, tantalum, titanium, cobalt, chromium, zirconium or tungsten at least 30 wt. %, and further at least 15 wt. % rhenium, l) containing one or more of niobium, tantalum, titanium, cobalt, chromium, zirconium or tungsten at least 50 wt. %, and further 1 to 40 wt. % of aluminum, bismuth, calcium, carbon, cerium oxide, copper, gold, hafnium, iridium, iron, lanthanum, lanthanum oxide, lead, magnesium, manganese, nickel, osmium, platinum, rare earth metals, rhodium, ruthenium, silicon, silver, technetium, tin, titanium, tungsten, vanadium, yttrium, yttrium oxide, zinc, and zirconium oxide, and further at least 15 wt. % rhenium, m) at least 60 wt. % tungsten, at least 15 wt. % rhenium, n) at least 60 wt. % tungsten, at least 15 wt. % rhenium, and at least 1 wt. % molybdenum, o) at least 50 wt. % rhenium, at least 20 wt. % chromium, and 0.1 to 80 wt. % of aluminum, bismuth, calcium, carbon, cerium oxide, chromium, cobalt, copper, gold, hafnium, iridium, iron, lanthanum, lanthanum oxide, lead, magnesium, manganese, molybdenum, nickel, niobium, osmium, platinum, rare earth metals, rhodium, ruthenium, silicon, silver, tantalum, technetium, tin, titanium, tungsten, vanadium, yttrium, yttrium oxide, zinc, zirconium,and one or more of zirconium oxide, p) titanium in excess of 50% by weight, niobium from 15 to 45% by weight, zirconium from 1 to 10% by weight, and tantalum from 1 to 15% by weight, q) titanium in excess of 50% by weight, niobium from 15 to 45% by weight, and from 1 to 10% by weight, r) cobalt from 30 to 60% by weight, chromium from 10 to 30% by weight, iron from 5 to 20% by weight, nickel from 5 to 22% by weight, and molybdenum from 2 to 12% by weight, s) zirconium from 40 to 60% by weight, and molybdenum from 40 to 60% by weight, t) niobium from 90 to 99.5% by weight, and zirconium from 0.5 to 10% by weight, or u) niobium from 55 to 75% by weight, tantalum from 18 to 40% by weight, tungsten from 1 to 7% by weight, and zirconium from 0.5 to 4% by weight, the method according to claim 20.,

23. The body portions of each of the first and second bone screws are formed from a metal alloy, the metal alloy being: a) stainless steel containing at least 15 wt. % rhenium; b) cobalt-chromium alloy containing at least 15 wt. % rhenium; c) TiNi alloy containing at least 15 wt. % rhenium; d) TiAlV alloy containing at least 15 wt. % rhenium; e) Al alloy containing at least 15 wt. % rhenium; f) Ni alloy containing at least 15 wt. % rhenium; g) Ti alloy containing at least 15 wt. % rhenium; h) W alloy containing at least 15 wt. % rhenium; i) Cu alloy containing at least 15 wt. % rhenium; j) beryllium-copper alloy containing at least 15 wt. % rhenium; k) containing one or more of niobium, tantalum, titanium, cobalt, chromium, zirconium or tungsten in an amount of at least 30 wt. %, and further containing at least 15 wt. % rhenium; l) containing one or more of niobium, tantalum, titanium, cobalt, chromium, zirconium or tungsten in an amount of at least 50 wt. %, and further containing 1 to 40 wt. % of one or more of aluminum, bismuth, calcium, carbon, cerium oxide, copper, gold, hafnium, iridium, iron, lanthanum, lanthanum oxide, lead, magnesium, manganese, nickel, osmium, platinum, rare earth metals, rhodium, ruthenium, silicon, silver, technetium, tin, titanium, tungsten, vanadium, yttrium, yttrium oxide, zinc, and zirconium oxide, and further containing at least 15 wt. % rhenium; m) containing at least 60 wt. % tungsten and at least 15 wt. % rhenium; n) containing at least 60 wt. % tungsten, at least 15 wt. % rhenium, and at least 1 wt. % molybdenum; o) containing at least 50 wt. % rhenium, at least 20 wt. % chromium, and 0.1 to 80 wt. % of one or more of aluminum, bismuth, calcium, carbon, cerium oxide, chromium, cobalt, copper, gold, hafnium, iridium, iron, lanthanum, lanthanum oxide, lead, magnesium, manganese, molybdenum, nickel, niobium, osmium, platinum, rare earth metals, rhodium, ruthenium, silicon, silver, tantalum, technetium, tin, titanium, tungsten, vanadium, yttrium, yttrium oxide, zinc,One or more of zirconium and zirconium oxide, p) titanium exceeding 50% by weight, niobium of 15 to 45% by weight, zirconium of 1 to 10% by weight, and tantalum of 1 to 15% by weight, q) titanium exceeding 50% by weight, niobium of 15 to 45% by weight, and 1 to 10% by weight, r) cobalt of 30 to 60% by weight, chromium of 10 to 30% by weight, iron of 5 to 20% by weight, nickel of 5 to 22% by weight, and molybdenum of 2 to 12% by weight, s) zirconium of 40 to 60% by weight, and molybdenum of 40 to 60% by weight, t) niobium of 90 to 99.5% by weight, and zirconium of 0.5 to 10% by weight, or u) niobium of 55 to 75% by weight, tantalum of 18 to 40% by weight, tungsten of 1 to 7% by weight, and zirconium of 0.5 to 4% by weight, the method according to claim 20.,

24. A method for forming a series of support rods that can be used in a surgical procedure, comprising: a. Forming first and second rods, each of the first and second rods having the same cross-sectional shape and size along the longitudinal length of the first and second rods, each of the first and second rods being formed from a metal alloy, and the metal alloy used to form the first and second rods being the same; b. subjecting the first metal rod to a final heat treatment process to change the flexibility of the metal alloy, change the bendability of the metal alloy, change the yield strength of the metal alloy, and / or change the ultimate tensile strength of the metal alloy on the first metal rod; c. subjecting the second metal rod to a final heat treatment process to change the flexibility of the metal alloy, change the bendability of the metal alloy, change the yield strength of the metal alloy, and / or change the ultimate tensile strength of the metal alloy in the first metal rod; d. cooling the first metal rod after the final heat treatment process; e. cooling the second metal rod after the final heat treatment process; f. applying a visual marking of the first rod to the first metal rod; g. applying a visual marking of the second rod to the second metal rod, comprising wherein the visual markings of the first and second rods are different; wherein the flexibility, bendability, yield strength and / or ultimate tensile strength of the first metal rod are different from those of the second metal rod because the first metal rod and the second metal rod are subjected to different I) final heat treatment times, II) temperatures during the final heat treatment, and / or III) cooling rates.

25. The method according to claim 24, wherein the final heat treatment process of one or both of the first and second metal rods does not quench one or both of the first and second metal rods.

26. The metal alloy of each of the first and second support rods is: a) stainless steel containing at least 15 wt.% of rhenium; b) cobalt-chromium alloy containing at least 15 wt.% of rhenium; c) TiNi alloy containing at least 15 wt.% of rhenium; d) TiAlV alloy containing at least 15 wt.% of rhenium; e) Al alloy containing at least 15 wt.% of rhenium; f) Ni alloy containing at least 15 wt.% of rhenium; g) Ti alloy containing at least 15 wt.% of rhenium; h) W alloy containing at least 15 wt.% of rhenium; i) Cu alloy containing at least 15 wt.% of rhenium; j) beryllium-copper alloy containing at least 15 wt.% of rhenium; k) containing one or more of niobium, tantalum, titanium, cobalt, chromium, zirconium or tungsten at least 30 wt.%, and further at least 15 wt.% of rhenium; l) containing one or more of niobium, tantalum, titanium, cobalt, chromium, zirconium or tungsten at least 50 wt.%, and further 1-40 wt.% of one or more of aluminum, bismuth, calcium, carbon, cerium oxide, copper, gold, hafnium, iridium, iron, lanthanum, lanthanum oxide, lead, magnesium, manganese, nickel, osmium, platinum, rare earth metals, rhodium, ruthenium, silicon, silver, technetium, tin, titanium, tungsten, vanadium, yttrium, yttrium oxide, zinc, and zirconium oxide, and further at least 15 wt.% of rhenium; m) at least 60 wt.% of tungsten, at least 15 wt.% of rhenium; n) at least 60 wt.% of tungsten, at least 15 wt.% of rhenium, and at least 1 wt.% of molybdenum; o) at least 50 wt.% of rhenium, at least 20 wt.% of chromium, and 0.1-80 wt.% of one or more of aluminum, bismuth, calcium, carbon, cerium oxide, chromium, cobalt, copper, gold, hafnium, iridium, iron, lanthanum, lanthanum oxide, lead, magnesium, manganese, molybdenum, nickel, niobium, osmium, platinum, rare earth metals, rhodium, ruthenium, silicon, silver, tantalum, technetium, tin, titanium, tungsten, vanadium, yttrium, yttrium oxide, zinc, zirconium.and one or more of zirconium oxide, p) titanium in excess of 50% by weight, niobium from 15 to 45% by weight, zirconium from 1 to 10% by weight, and tantalum from 1 to 15% by weight, q) titanium in excess of 50% by weight, niobium from 15 to 45% by weight, and from 1 to 10% by weight, r) cobalt from 30 to 60% by weight, chromium from 10 to 30% by weight, iron from 5 to 20% by weight, nickel from 5 to 22% by weight, and molybdenum from 2 to 12% by weight, s) zirconium from 40 to 60% by weight, and molybdenum from 40 to 60% by weight, t) niobium from 90 to 99.5% by weight, and zirconium from 0.5 to 10% by weight, or u) niobium from 55 to 75% by weight, tantalum from 18 to 40% by weight, tungsten from 1 to 7% by weight, and zirconium from 0.5 to 4% by weight, the method according to claim 24.,

27. The method according to claim 24, wherein the maximum temperature of the final heat treatment, or one or both of the first and second metal rods, is 500 to 1000 °C.

28. The method according to claim 24, wherein one or both of the first and second metal rods are subjected to the final heat treatment process for about 0.5 to 25 hours.

29. The step of subjecting the first metal rod to a final heat treatment process includes: a) first, raising the temperature around the first metal rod from a minimum temperature to a maximum temperature for a first time; b) maintaining the maximum temperature around the first metal rod for a second time. The step of subjecting the second metal rod to a final heat treatment process includes: a) first, raising the temperature around the second metal rod from a minimum temperature to a maximum temperature for a first time; b) maintaining the maximum temperature around the second metal rod for a second time. The method according to claim 24, wherein the minimum temperature is 10 to 250 °C for one or both of the first and second metal rods, the first time is 0.5 to 10 hours for one or both of the first and second metal rods, the second time is 0.01 to 15 hours for one or both of the first and second metal rods, and the first time and / or the second time for the first metal rod is different from that of the second metal rod.

30. The minimum temperature is 10 to 250 °C for one or both of the first and second metal rods, the first time is 0.5 to 10 hours for one or both of the first and second metal rods, the second time is 0.01 to 15 hours for one or both of the first and second metal rods, and the first time and / or the second time for the first metal rod is different from that of the second metal rod. The method according to claim 29.

31. The method according to claim 24, wherein one or both of the first and second metal rods are cooled at a rate of less than 100 °C / second during the cooling step.

32. The cooling step is performed in: a) a non-oxidizing gas environment at a temperature of 10 to 100 °C; b) an inert gas environment at a temperature of 10 to 100 °C; or c) an atmospheric environment at a temperature of 10 to 100 °C. The method according to claim 31.

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