Heat treatment of metal alloy

Abstract

The present disclosure relates to a medical device comprising a specially heat treated component and a method of heat treating a metal alloy for the medical device.

Description

[0001] The present disclosure is a continuation-in-part of U.S. patent application serial number 18 / 116,677 filed on March 2, 2023, which in turn claims priority to U.S. provisional application serial number 63 / 316,077 filed on March 3, 2022, which is incorporated herein by reference.

[0002] The present disclosure is a continuation-in-part of U.S. patent application serial number 17 / 876,282 filed on July 28, 2022, which in turn claims priority to U.S. provisional application serial number 63 / 247,540 filed on September 23, 2021, which is incorporated herein by reference.

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

[0004] The present disclosure relates generally to heat treatment of metals, more specifically to heat treatment of refractory metal alloys or metal alloys containing at least 15 atomic weight percent (awt.%) rhenium, even more specifically to heat treatment of refractory metal alloys or metal alloys containing at least 15 awt.% rhenium, wherein the heat-treated refractory metal alloys or metal alloys containing at least 15 awt.% rhenium are to be used partially or completely in medical devices, and even more specifically to heat treating refractory metal alloys or metal alloys containing at least 15 awt.% rhenium to produce a variable yield strength and / or ultimate tensile strength along the longitudinal length of the metal alloy, and wherein the heat-treated refractory metal alloys or metal alloys containing at least 15 awt.% rhenium are to be used partially or completely in medical devices. Background Art

[0005] Stainless steel, cobalt-chromium alloys, and TiAlV alloys are some of the more common metal alloys used in medical devices. Although these alloys have been successfully used to form a variety of medical devices, these alloys still have some drawbacks.

[0006] Refractory metal alloys and metal alloys containing at least 15awt.% rhenium have been found to overcome many of these defects. Refractory metal alloys and metal alloys containing at least 15awt.% rhenium can be harder and stronger than other metal alloys. In some applications (medical applications such as spinal surgery), medical devices (such as spinal rods) formed by metal alloys need to have a certain degree of flexibility or bendability. In order to increase the flexibility or bendability of the metal alloy rod, the rod is usually ground to reduce the cross-sectional area of ​​the rod, thereby making the rod more flexible. Therefore, rods of different sizes are provided to surgeons during spinal procedures. However, the problem with using rods of different diameters is that rods of different sizes usually require different screws, which may complicate surgery due to having to track the rods used in the medical procedure, and may also potentially lead to the use of incorrect screws during the procedure. Summary of the invention

[0007] The present disclosure relates generally to heat treatment of metals, more particularly to heat treatment of refractory metal alloys or metal alloys containing at least 15 atomic weight percent (awt.%) rhenium, still more particularly to heat treatment of refractory metal alloys or metal alloys containing at least 15 awt.% rhenium, wherein the heat-treated refractory metal alloys or metal alloys containing at least 15 awt.% rhenium are to be used partially or completely in medical devices, and still more particularly to heat treating refractory metal alloys or metal alloys containing at least 15 awt.% rhenium to produce a variable yield strength and / or ultimate tensile strength along the longitudinal length of the metal alloy, and wherein the heat-treated refractory metal alloys or metal alloys containing at least 15 awt.% rhenium are to be used partially or completely in medical devices. As defined herein, a refractory metal alloy is a metal alloy containing at least 20 weight percent 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, the medical device may include, but is not limited to, an orthopedic device, a PFO (patent foramen ovale) device, a stent, a valve (e.g., a heart valve, a TAVR valve, a mitral valve replacement, a tricuspid valve replacement, a pulmonary valve replacement, etc.), a spinal implant, a spinal disc, a frame and other structures used with a spinal implant, a vascular implant, a graft, a guidewire, a sheath, a catheter, a needle, a stent catheter, an electrophysiology catheter, a hypotube, a staple, a cutting device, an implant of any type, a pacemaker, a dental implant, a crown, a brace, a wire used in a medical procedure, a bone implant, an artificial intervertebral disc, an artificial spinal disc, a prosthetic implant, or a device for repairing, replacing, and / or supporting bones (e.g., acromion, atlas, axis, calcaneus, etc.). Devices, bone plates, knee replacements, hip replacements, shoulder replacements, ankle replacements, nails, rods, screws, posts, cages, plates, pedicle screws, caps, hinges, joint systems, anchors, washers, shafts, anchors, discs, balls, tension bands, locking connectors, other structural components used in the body to support, mount and / or repair structures in the body (such as, but not limited to, the human body, animal body, etc.).

[0009] According to one non-limiting aspect of the present disclosure, the metal alloy used to partially or completely 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 a metal alloy containing at least 15 atomic weight percent (awt.%) rhenium. As defined herein, standard stainless steel alloys include 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% Se, 0-2 wt% vanadium, 0-2 wt% tungsten, and at least 50 wt% iron. Standard 316L alloy includes 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, the remainder iron. As defined herein, the standard CoCr alloy comprises 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, 30-68 wt% cobalt. As defined herein, the standard MP35N alloy comprises 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, the remainder 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, 6-8 wt% molybdenum. As defined herein, standard L605 alloy contains 18-22 wt% chromium, 14-16 wt% tungsten, 9-11 wt% nickel, the remainder cobalt. As defined herein, 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, 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 remainder 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, 0-0.3 wt% iron, and 0-0.5 wt% chromium. Zinc, 0%-0.5% titanium, 0%-3% lithium, 0%-0.5% silver, 0%-0.5% calcium, 0%-0.5% zirconium, 0%-1% lead, 0%-0.5% cadmium, 0%-0.05% bismuth, 0%-1% nickel, 0%-0.2% vanadium, 0%-0.1% gallium and 0%-7% copper. As defined herein, standard nickel alloy contains 30 wt%-98 wt% nickel, 5 wt%-25 wt% chromium, 0 wt%-65 wt% iron, 0 wt%-30 wt% molybdenum, 0 wt%-32% wt% copper, 0 wt%-32% wt% cobalt, 2 wt%-2 wt% aluminum, 0 wt%-6 wt% tantalum, 0 wt%-15% wt% tungsten, 0 wt%-5 wt% titanium, 0 wt%-6 wt% niobium, and 0 wt%-3 wt% silicon. As defined herein, a standard titanium alloy comprises 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, 0-2 wt% iron. As defined herein, a standard tungsten alloy comprises 85-98 wt% tungsten, 0-8 wt% nickel, 0-5 wt% copper, 0-5 wt% molybdenum, 0-4 wt% iron. As defined herein, a standard molybdenum alloy comprises 90 wt %-99.5 wt % molybdenum, 0 wt %-1 wt % nickel, 0 wt %-1 wt % titanium, 0 wt %-1 wt % zirconium, 0 wt %-30 wt % tungsten, 0 wt %-2 wt % hafnium, 0 wt %-2 wt % lanthanum.As defined herein, standard copper alloy comprises 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, the standard MP35N alloy comprises 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 remainder cobalt. As defined herein, the standard beryllium-copper alloy comprises 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 comprising at least 20 wt% of one or more of molybdenum, rhenium, niobium, tantalum, or tungsten. Non-limiting refractory metal alloys include MoRe alloys, ReW alloys, MoReCr alloys, MoReTa alloys, MoReTi alloys, WCu alloys, ReCr, molybdenum alloys, rhenium alloys, tungsten alloys, tantalum alloys, niobium alloys, and the like.

[0010] According to another and / or alternative aspect of the present disclosure, the metal alloy comprises at least 15 awt.% 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 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 the metal alloy exhibits a rhenium effect. As defined herein, a "rhenium effect" is a) at least a 10% increase in the ductility of a metal alloy caused by the addition of rhenium to the metal alloy, and / or b) at least a 10% increase in the tensile strength of a metal alloy caused by the addition of rhenium to the metal alloy. It has been found that many metal alloys (e.g., standard stainless steel, 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.) all result in increased ductility and / or tensile strength. It has been found that the addition of rhenium to a metal alloy can result in the formation of a twin alloy in the metal alloy that results in an increase in the overall ductility of the metal alloy with an increase in yield strength and tensile strength due to reduction and / or work hardening of the metal alloy containing the rhenium addition. The rhenium effect occurs when the atomic weight of rhenium in the metal alloy is at least 15% (e.g., 15 awt.%-99 awt.% rhenium in the metal alloy and all values ​​and ranges therebetween). For example, for a standard stainless steel alloy, the rhenium effect can begin to occur when the stainless steel alloy is modified to include at least 5 wt.%-10 wt.% of the stainless steel alloy (and all values ​​and ranges therebetween) of rhenium. For a standard CoCr alloy, the rhenium effect may begin to occur when the CoCr alloy is modified to include a rhenium amount of at least 4.8 wt %-9.5 wt % (and all values ​​and ranges therebetween) of the CoCr alloy. For a standard TiAlV alloy, the rhenium effect may begin to occur when the TiAlV alloy is modified to include a rhenium amount of at least 4.5 wt %-9 wt % (and all values ​​and ranges therebetween) of the TiAlV alloy. It will be appreciated that the rhenium content in the above examples may be greater than the minimum amount to produce the rhenium effect in the metal alloy.

[0011] According to another and / or alternative aspect of the present disclosure, the metal alloy comprises at least 15 awt.% 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 the metal alloy exhibits 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 sufficient amount of rhenium to produce a 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 sufficient amount of rhenium to produce a rhenium effect in the metal alloy, and the metal alloy is a standard stainless steel alloy that has been modified to contain at least 15 awt. % 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 sufficient amount of rhenium to produce a rhenium effect in the metal alloy, and the metal alloy is a standard cobalt-chromium alloy that has been modified to contain at least 15 awt. % rhenium.

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

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

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

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

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

[0020] According to another and / or alternative aspect of the present disclosure, the metal alloy is a standard molybdenum alloy or a metal alloy containing sufficient amount of rhenium to produce a rhenium effect in the metal alloy, and the metal alloy is a standard molybdenum alloy that has been modified to contain at least 15 awt. % 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 sufficient amount of rhenium to produce a rhenium effect in the metal alloy, and the metal alloy is a standard copper alloy that has been modified to contain at least 15 awt. % 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 sufficient amount of rhenium to produce a rhenium effect in the metal alloy, and the metal alloy is a standard MP35N alloy that has been modified to contain at least 15 awt. % 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 sufficient amount of rhenium to produce a rhenium effect in the metal alloy, and the metal alloy is a standard beryllium-copper alloy that has been modified to contain at least 15 awt. % rhenium.

[0024] Several non-limiting examples of metal alloys that may be used to partially or completely form the framework of a medical device are set forth below in weight percent:

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[0067] In Examples 1 to 210, it should be understood that all of the above ranges include any value between that range and any other range between the ranges set forth above. Any of the above values ​​including the ≤ symbol includes a range from 0 to the specified value and all values ​​and ranges therebetween.

[0068] According to another and / or alternative non-limiting aspect of the present disclosure, a metal alloy for partially or completely forming a medical device contains sufficient amount of rhenium in the metal alloy to produce a "rhenium effect". As defined herein, the "rhenium effect" is a) at least a 10% increase in the ductility of the metal alloy caused by the addition of rhenium to the metal alloy, and / or b) at least a 10% increase in the tensile strength of the metal alloy caused by the addition of rhenium to the metal alloy. It has been found that many metal alloys result in improved ductility and / or tensile strength. It has been found that the addition of rhenium to a metal alloy can result in the formation of twin alloys in the metal alloy, which twin alloys result in an increase in the overall ductility of the metal alloy with an increase in yield strength and tensile strength due to reduction and / or work hardening of the metal alloy containing the rhenium addition. The "rhenium effect" occurs when the atomic weight of rhenium in the metal alloy is at least 15% (e.g., 15awt.%-99awt.% rhenium in the metal alloy and all values ​​and ranges therebetween). For example, for a standard stainless steel alloy, the "rhenium effect" may begin to appear when the stainless steel alloy is modified to include a rhenium amount of at least 5 wt%-10 wt% (and all values ​​and ranges therebetween) of the stainless steel alloy. For a standard CoCr alloy, the "rhenium effect" may begin to appear when the CoCr alloy is modified to include a rhenium amount of at least 4.8 wt%-9.5 wt% (and all values ​​and ranges therebetween) of the CoCr alloy. For a standard TiAlV alloy, the "rhenium effect" may begin to appear when the TiAlV alloy is modified to include a rhenium amount of at least 4.5 wt%-9 wt% (and all values ​​and ranges therebetween) of the TiAlV alloy. It will be appreciated that the rhenium content in the above examples may be greater than the minimum amount to produce the "rhenium effect" in the metal alloy.

[0069] According to another and / or alternative non-limiting aspect of the present disclosure, a metal alloy for partially or completely forming a medical device comprises at least 15 awt.% rhenium (e.g., 15 awt.%-99.9 awt.% and all values ​​and ranges therebetween), and at least 0.1 wt.% (e.g., 0.1 wt.% to 96 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. In another non-limiting embodiment, the metal alloy includes at least 15 awt.% rhenium (e.g., 15 awt.%-99.9 awt.% and all values ​​and ranges therebetween), and at least 0.1 wt.% (e.g., 0.1 wt.% to 96 wt.% and 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 includes at least 15 awt.% rhenium (e.g., 15 awt.%-99.9 awt.% and all values ​​and ranges therebetween), and at least 0.1 wt.% (e.g., 0.1 wt.% to 96 wt.% and 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.

[0070] According to another and / or alternative non-limiting aspect of the present disclosure, a metal alloy for partially or completely forming a medical device includes: at least 30% by weight (e.g., 30% by weight-100% by weight and all values ​​and ranges therebetween) of the metal alloy comprises one or more of molybdenum, niobium, rhenium, tantalum, or tungsten. In another non-limiting embodiment, at least 40% by weight of the metal alloy comprises one or more of molybdenum, niobium, rhenium, tantalum, or tungsten. In another non-limiting embodiment, at least 50% by weight of the metal alloy comprises one or more of molybdenum, niobium, rhenium, tantalum, or tungsten.

[0071] In another non-limiting embodiment, a metal alloy for partially or completely forming a medical device comprises: at least 50% by weight (e.g., 50-100% by weight and all values ​​and ranges therebetween) of the metal alloy comprises one or more of molybdenum, niobium, rhenium, tantalum, titanium, zirconium, or tungsten, and 0% by weight -40% by weight (and all values ​​and ranges therebetween) of the metal alloy comprises 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 comprises 0% by weight -2% by weight (and all values ​​and ranges therebetween) of a combination of other metals, carbon, oxygen, phosphorus, sulfur, hydrogen, and nitrogen.

[0072] According to another and / or alternative non-limiting aspect of the present disclosure, a metal alloy for partially or completely forming a medical device includes: at least 20 wt % (e.g., 20 wt %-99 wt % and all values ​​and ranges therebetween) of the metal alloy comprises rhenium. In one non-limiting embodiment, the metal alloy comprises at least 20 wt % (e.g., 20 wt %-99.9 wt % and all values ​​and ranges therebetween) rhenium, and 0.1 wt %-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, nickel, osmium, platinum, rare earth metals, rhodium, ruthenium, silver, technetium, vanadium, yttrium, yttrium oxide, zinc, and / or zirconium oxide, and the metal alloy comprises 0 wt %-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% to 60% by weight of the metal alloy (e.g., and all values ​​and ranges therebetween) comprises rhenium, and 40% to 65% by weight of the metal alloy (and all values ​​and ranges therebetween) comprises two or more of molybdenum, niobium, tantalum, tantalum, titanium, vanadium, chromium, manganese, zirconium, technetium, ruthenium, rhodium, hafnium, osmium, copper, and / or iridium. In another non-limiting embodiment, 35% to 60% by weight of the metal alloy comprises rhenium, and 40% to 65% by weight of the metal alloy comprises three or more of molybdenum, niobium, tantalum, 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% by weight and less than 60% by weight (and all values ​​and ranges therebetween). In another non-limiting embodiment, the weight percent of rhenium in the metal alloy is 35 wt %-60 wt % (and all values ​​and ranges therebetween). In another non-limiting embodiment, the combined weight percent of the alloying metals is 5 wt %-45 wt % 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 percent of rhenium, molybdenum, and one or more alloying metals in the metal alloy is at least 99.9 wt %. According to another and / or alternative non-limiting aspect of the present disclosure, the atomic weight percent of rhenium to the atomic weight percent of the combination 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 still more typically about 0.9:1 to 1.1:1 (e.g., 1:1).In one specific non-limiting formulation, the atomic weight percent of rhenium to the atomic weight percent of the combination 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 specific non-limiting formulation, the atomic weight percent of rhenium to the atomic weight percent of the combination 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 example, when the metal alloy includes 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 (and all values ​​and ranges therebetween), and typically 0.5:1 to 2:1.

[0073] In another non-limiting aspect of the present disclosure, a metal alloy for partially or completely forming 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 alloys of one or more of such components (e.g., WRe, WReMo, etc.), and the metal alloy comprises 0 wt%-2 wt% (and all values ​​and ranges therebetween) of a combination of other metals, carbon, oxygen, phosphorus, sulfur, hydrogen, and nitrogen. 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 percentage of tungsten and rhenium in the tungsten-rhenium alloy is at least about 95 weight percent, typically at least about 99 weight percent, more typically at least about 99.5 weight percent, more typically at least about 99.9 weight percent, and more typically at least about 99.99 weight percent. In another non-limiting formulation, the metal alloy contains up to 47.5 weight percent rhenium and at least 20 weight percent-80 weight percent tungsten (and all values ​​and ranges therebetween) and 1 weight percent-47.5 weight percent molybdenum (and all values ​​and ranges therebetween). In another non-limiting specific tungsten-rhenium-molybdenum alloy, the weight percentage of tungsten is greater than 50 weight percent of the tungsten-rhenium-molybdenum alloy. In another non-limiting specific tungsten-rhenium-molybdenum alloy, the weight percentage of tungsten is greater than the weight percentage of rhenium, but less than the weight percentage of molybdenum. In another non-limiting specific tungsten-rhenium-molybdenum alloy, the weight percentage of tungsten is greater than the weight percentage of molybdenum, but less than the weight percentage of rhenium. In another non-limiting specific tungsten-rhenium-molybdenum alloy, the weight percentage of tungsten is greater than the weight percentage of molybdenum, but less than the weight percentage of rhenium. In another non-limiting particular tungsten-rhenium-molybdenum alloy, the weight percent of tungsten is less than the weight percent of rhenium and also less than the weight percent of molybdenum.

[0074] 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 at least 35% by weight (e.g., 35% by weight-75% by weight and all values ​​and ranges therebetween) of rhenium, and the metal alloy further comprises chromium. In one non-limiting embodiment, at least 25% by weight (e.g., 25% by weight-49.9% by weight and all values ​​and ranges therebetween) of the metal alloy comprises chromium. In another non-limiting embodiment, at least 30% by weight of the metal alloy comprises chromium. In another non-limiting embodiment, at least 33% by weight of the metal alloy comprises chromium. In another non-limiting embodiment, at least 50 wt. % (e.g., 50 wt. %-74.9 wt. % and all values ​​and ranges therebetween) of the metal alloy comprises rhenium, at least 25 wt. % (e.g., 25 wt. %-49.9 wt. % and all values ​​and ranges therebetween) of the metal alloy comprises chromium, and 0.1 wt. %-25 wt. % (and all values ​​and ranges therebetween) of the metal alloy comprises 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 wt %-69.9 wt % and all values ​​and ranges therebetween) of the metal alloy comprises rhenium, at least 30 wt % (e.g., 30 wt %-44.9 wt % and all values ​​and ranges therebetween) of the metal alloy comprises chromium, and 0.1 wt %-15 wt % (and all values ​​and ranges therebetween) of the metal alloy comprises 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 alloying metal comprises 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 alloy metal comprises chromium and one or more metals selected from the group consisting of bismuth, zirconium, iridium, niobium, tantalum, titanium, and yttrium; and wherein the atomic ratio of chromium to the atomic ratio of each or all of 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 alloy metal comprises chromium and one or more metals selected from the group consisting of zirconium, niobium, and tantalum. In another non-limiting embodiment, the alloy 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; and wherein the first metal and the second metal are different; and wherein 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; and wherein the first metal and the second metal are different; and wherein the atomic ratio of the first metal to the second metal is from 0.4:1 to 2.5:1 (and all values ​​and ranges therebetween).

[0075] According to another and / or alternative non-limiting aspect of the present disclosure, a metal alloy for partially or completely forming a medical device comprises 10 atomic weight percent (awt.%)-60 awt.% 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 a non-limiting embodiment, the metal alloy comprises 15 awt.%-60 awt.% 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 awt.%-60 awt.% Re and one or more metals selected from the group consisting of 0.5 awt.%-70 awt.% Cr (and all values ​​and ranges therebetween), 0.5 awt.%-70 awt.% Ta (and all values ​​and ranges therebetween), 0.5 awt.%-70 awt.% Nb (and all values ​​and ranges therebetween), 0.5 awt.%-70 awt.% Ti (and all values ​​and ranges therebetween), and 0.5 awt.%-70 awt.% Zr (and all values ​​and ranges therebetween).

[0076] According to another and / or alternative non-limiting aspect of the present disclosure, a metal alloy for partially or completely forming a medical device comprises 0.5 awt.%-50 awt.% Re (and all values ​​and ranges therebetween) and 0.5 awt.%-70 awt.% Cr (and all values ​​and ranges therebetween).

[0077] According to another and / or alternative non-limiting aspect of the present disclosure, a metal alloy for partially or completely forming a medical device comprises 0.5 awt.%-50 awt.% Re (and all values ​​and ranges therebetween) and 0.5 awt.%-70 awt.% Ta (and all values ​​and ranges therebetween).

[0078] According to another and / or alternative non-limiting aspect of the present disclosure, a metal alloy for partially or completely forming a medical device comprises 0.5 awt.%-50 awt.% Re (and all values ​​and ranges therebetween) and 0.5 awt.%-70 awt.% Nb (and all values ​​and ranges therebetween).

[0079] According to another and / or alternative non-limiting aspect of the present disclosure, a metal alloy for partially or completely forming a medical device comprises 0.5 awt.%-50 awt.% Re (and all values ​​and ranges therebetween) and 0.5 awt.%-70 awt.% Ti (and all values ​​and ranges therebetween).

[0080] According to another and / or alternative non-limiting aspect of the present disclosure, a metal alloy for partially or completely forming a medical device comprises greater than 50 wt % titanium (e.g., 51 wt %-80 wt % and all values ​​and ranges therebetween), 15 wt %-45 wt % (and all values ​​and ranges therebetween) niobium, 1 wt %-10 wt % (and all values ​​or ranges therebetween) zirconium, and 1 wt %-15 wt % (and all values ​​and ranges therebetween) tantalum. In one non-limiting formulation, the metal alloy comprises 58 wt %-70 wt % titanium, 27 wt %-37 wt % niobium, 2 wt %-9 wt % zirconium, and 1 wt %-15 wt % tantalum.

[0081] According to another and / or alternative non-limiting aspect of the present disclosure, a metal alloy for partially or completely forming a medical device comprises greater than 50 wt % titanium (e.g., 51 wt %-80 wt % and all values ​​and ranges therebetween), 15 wt %-45 wt % (and all values ​​and ranges therebetween) niobium, and 1 wt %-10 wt % (and all values ​​and ranges therebetween) molybdenum. In one non-limiting formulation, the metal alloy comprises 58 wt %-69 wt % titanium, 27 wt %-33 wt % niobium, and 4 wt %-8 wt % molybdenum.

[0082] According to another and / or alternative non-limiting aspect of the present disclosure, a metal alloy for partially or completely forming a medical device comprises 30 wt %-60 wt % cobalt (and all values ​​and ranges therebetween), 10 wt %-30 wt % chromium (and all values ​​and ranges therebetween), 5 wt %-20 wt % iron (and all values ​​and ranges therebetween), 5 wt %-22 wt % nickel (and all values ​​and ranges therebetween), and 2 wt %-12 wt % molybdenum (and all values ​​and ranges therebetween). In one non-limiting formulation, the metal alloy comprises 35 wt %-45 wt % cobalt, 15 wt %-25 wt % chromium, 12 wt %-20 wt % iron, 10 wt %-20 wt % nickel, and 5 wt %-9 wt % molybdenum.

[0083] According to another and / or alternative non-limiting aspect of the present disclosure, a metal alloy for partially or completely forming a medical device comprises 40 wt %-60 wt % zirconium (and all values ​​and ranges therebetween) and 40 wt %-60 wt % molybdenum (and all values ​​and ranges therebetween). In one non-limiting formulation, the metal alloy comprises 45 wt %-55 wt % cobalt and 45 wt %-55 wt % molybdenum.

[0084] According to another and / or alternative non-limiting aspect of the present disclosure, a metal alloy for partially or completely forming a medical device comprises 90 wt %-99.5 wt % niobium (and all values ​​and ranges therebetween) and 0.5 wt %-10 wt % zirconium (and all values ​​and ranges therebetween). In one non-limiting formulation, the metal alloy comprises 95 wt %-99.25 wt % niobium and 0.75 wt %-4 wt % niobium.

[0085] According to another and / or alternative non-limiting aspect of the present disclosure, a metal alloy for partially or completely forming a medical device comprises 55 wt %-75 wt % niobium (and all values ​​and ranges therebetween), 18 wt %-40 wt % tantalum (and all values ​​and ranges therebetween), 1 wt %-7 wt % tungsten (and all values ​​and ranges therebetween), and 0.5 wt %-4 wt % zirconium (and all values ​​and ranges therebetween). In one non-limiting formulation, the metal alloy comprises 60 wt %-70 wt % niobium, 24 wt %-32 wt % tantalum, 2 wt %-5 wt % tungsten, and 0.75 wt %-3 wt % zirconium.

[0086] In another and / or alternative non-limiting aspect of the present disclosure, a metal alloy for partially or completely forming a medical device comprises rhenium plus 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 the metal alloy containing other elements and compounds is 0 wt%-0.1 wt%, typically 0 wt%-0.01 wt% and more preferably 0 wt%-0.001 wt%. In another specific non-limiting formulation, the metal alloy is formed by rhenium plus at least two metals selected from the group consisting of bismuth, chromium, iridium, niobium, tantalum, titanium, yttrium and zirconium, and the content of the metal alloy containing other elements and compounds is 0 wt%-0.1 wt%, typically 0 wt%-0.01 wt% and more preferably 0 wt%-0.001 wt%. In another specific non-limiting formulation, the metal alloy is formed of rhenium plus at least three metals selected from the group consisting of rhenium, molybdenum, chromium, niobium, tantalum and zirconium, and the content of the metal alloy containing other elements and compounds is 0 wt %-0.1 wt %, typically 0 wt %-0.01 wt % and more preferably 0 wt %-0.001 wt %.

[0087] According to another and / or alternative non-limiting aspect of the present disclosure, the metal alloy comprises 10 atomic weight percent (awt.%)-60 awt.% 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 a non-limiting embodiment, the metal alloy comprises 15 awt.%-60 awt.% 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 awt.%-60 awt.% Re and one or more metals selected from the group consisting of 0.5 awt.%-70 awt.% Cr (and all values ​​and ranges therebetween), 0.5 awt.%-70 awt.% Ta (and all values ​​and ranges therebetween), 0.5 awt.%-70 awt.% Nb (and all values ​​and ranges therebetween), 0.5 awt.%-70 awt.% Ti (and all values ​​and ranges therebetween), and 0.5 awt.%-70 awt.% Zr (and all values ​​and ranges therebetween).

[0088] According to another and / or alternative non-limiting aspect of the present disclosure, the metal alloy comprises 0.5 awt.%-50 awt.% Re (and all values ​​and ranges therebetween) and 0.5 awt.%-70 awt.% Cr (and all values ​​and ranges therebetween).

[0089] According to another and / or alternative non-limiting aspect of the present disclosure, the metal alloy comprises 0.5 awt.%-50 awt.% Re (and all values ​​and ranges therebetween) and 0.5 awt.%-70 awt.% Ta (and all values ​​and ranges therebetween).

[0090] According to another and / or alternative non-limiting aspect of the present disclosure, the metal alloy comprises 0.5 awt.%-50 awt.% Re (and all values ​​and ranges therebetween) and 0.5 awt.%-70 awt.% Nb (and all values ​​and ranges therebetween).

[0091] According to another and / or alternative non-limiting aspect of the present disclosure, the metal alloy comprises 0.5 awt.%-50 awt.% Re (and all values ​​and ranges therebetween) and 0.5 awt.%-70 awt.% Ti (and all values ​​and ranges therebetween).

[0092] 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 wt %-80 wt % and all values ​​and ranges therebetween), 15 wt %-45 wt % (and all values ​​and ranges therebetween) niobium, 1 wt %-10 wt % (and all values ​​or ranges therebetween) zirconium, and 1 wt %-15 wt % (and all values ​​and ranges therebetween) tantalum. In one non-limiting formulation, the metal alloy comprises 58 wt %-70 wt % titanium, 27 wt %-37 wt % niobium, 2 wt %-9 wt % zirconium, and 1 wt %-15 wt % tantalum.

[0093] 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 wt %-80 wt % and all values ​​and ranges therebetween), 15 wt %-45 wt % (and all values ​​and ranges therebetween) niobium, and 1 wt %-10 wt % (and all values ​​and ranges therebetween) molybdenum. In one non-limiting formulation, the metal alloy comprises 58 wt %-69 wt % titanium, 27 wt %-33 wt % niobium, and 4 wt %-8 wt % molybdenum.

[0094] According to another and / or alternative non-limiting aspect of the present disclosure, the metal alloy comprises 30 wt %-60 wt % cobalt (and all values ​​and ranges therebetween), 10 wt %-30 wt % chromium (and all values ​​and ranges therebetween), 5 wt %-20 wt % iron (and all values ​​and ranges therebetween), 5 wt %-22 wt % nickel (and all values ​​and ranges therebetween), and 2 wt %-12 wt % molybdenum (and all values ​​and ranges therebetween). In one non-limiting formulation, the metal alloy comprises 35 wt %-45 wt % cobalt, 15 wt %-25 wt % chromium, 12 wt %-20 wt % iron, 10 wt %-20 wt % nickel, and 5 wt %-9 wt % molybdenum.

[0095] According to another and / or alternative non-limiting aspect of the present disclosure, the metal alloy comprises 40 wt %-60 wt % zirconium (and all values ​​and ranges therebetween) and 40 wt %-60 wt % molybdenum (and all values ​​and ranges therebetween). In one non-limiting formulation, the metal alloy comprises 45 wt %-55 wt % cobalt and 45 wt %-55 wt % molybdenum.

[0096] According to another and / or alternative non-limiting aspect of the present disclosure, the metal alloy comprises 90 wt %-99.5 wt % niobium (and all values ​​and ranges therebetween) and 0.5 wt %-10 wt % zirconium (and all values ​​and ranges therebetween). In one non-limiting formulation, the metal alloy comprises 95 wt %-99.25 wt % niobium and 0.75 wt %-4 wt % niobium.

[0097] According to another and / or alternative non-limiting aspect of the present disclosure, the metal alloy comprises 55 wt %-75 wt % niobium (and all values ​​and ranges therebetween), 18 wt %-40 wt % tantalum (and all values ​​and ranges therebetween), 1 wt %-7 wt % tungsten (and all values ​​and ranges therebetween), and 0.5 wt %-4 wt % zirconium (and all values ​​and ranges therebetween). In one non-limiting formulation, the metal alloy comprises 60 wt %-70 wt % niobium, 24 wt %-32 wt % tantalum, 2 wt %-5 wt % tungsten, and 0.75 wt %-3 wt % zirconium.

[0098] In another and / or alternative non-limiting aspect of the present disclosure, the metal alloy used to partially or completely form a medical device contains less than about 5 wt % (e.g., 0 wt %-4.999999 wt % and all values ​​and ranges therebetween) other metals and / or impurities, typically 0 wt %-1 wt %, more typically 0 wt %-0.1 wt %, even more typically 0 wt %-0.01 wt %, and even more typically 0-0.001 wt %. The high purity level of the metal alloy results in the formation of a more homogeneous alloy, which in turn results in a more uniform density throughout the metal alloy, and also results in the desired yield strength and ultimate tensile strength of the metal alloy.

[0099] In another and / or alternative non-limiting aspect of the present disclosure, the metal alloy used to partially or completely form the medical device contains a certain amount of carbon and oxygen; however, this is not required. It has been found that these two elements affect the forming properties and brittleness of the metal alloy. The controlled atomic ratio of carbon and oxygen of 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% by weight (e.g., 0% by weight to 0.1999999% by weight and all values ​​and ranges therebetween). Excessive carbon content may adversely affect the physical properties of the metal alloy. Typically, the oxygen content should be maintained at a very low level. In a non-limiting formulation of the metal alloy, the oxygen content is less than about 0.1% by weight of the metal alloy (e.g., 0% by weight to 0.0999999% by weight and all values ​​and ranges therebetween). In another non-limiting embodiment, the metal alloy optionally contains a controlled amount of nitrogen; however, this is not required. Large amounts of nitrogen in the metal alloy may adversely affect the ductility of the metal alloy. This in turn may adversely affect the elongation properties of the metal alloy. Excessive nitrogen content in the metal alloy may begin to cause the ductility of the metal alloy to be unacceptably reduced, thereby adversely affecting one or more physical properties of the metal alloy that are useful or desired when forming and / or using a medical device. In a non-limiting formulation, the metal alloy contains less than about 0.001% by weight nitrogen (e.g., 0% by weight to 0.0009999% by weight and all values ​​and ranges therebetween). It is believed that the nitrogen content should be less than the carbon or oxygen content in the metal alloy. In a 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 oxygen to nitrogen atomic ratio is at least about 1.2:1 (e.g., 1.2:1 to 150:1 and all values ​​and ranges therebetween).

[0100] According to another and / or alternative non-limiting aspect of the present disclosure, a metal alloy for partially or completely forming a medical device: a) has an average Vickers hardness of, optionally, at least about 150 Vickers (e.g., 150 Vickers-300 Vickers and all values ​​and ranges therebetween), b) an average hardness greater than that of stainless steel (e.g., 304 grade, 316 grade), c) an average ultimate tensile strength of, optionally, at least about 100 ksi (e.g., 100 ksi-350 ksi and all values ​​and ranges therebetween), d) an average yield strength of, optionally, at least about 80 ksi (e.g., 80 ksi-300 ksi and all values ​​and ranges therebetween), e) no greater than about 4 ASTM (e.g., using ASTM E112 has an average grain size of 4 ASTM to 20 ASTM and all values ​​and ranges therebetween, such as 0.35 microns to 90 microns and all values ​​and ranges therebetween), and e) optionally an average tensile elongation of at least about 25% (e.g., 25%-50% average tensile elongation and all values ​​and ranges therebetween).

[0101] According to another and / or alternative non-limiting aspect of the present disclosure, a medical device partially or completely formed of a refractory metal alloy is provided. 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%-100% (and all values ​​and ranges therebetween) of the medical device is formed of a refractory metal alloy. In another non-limiting embodiment, 50%-100% (and all values ​​and ranges therebetween) of the medical device is formed of a MoRe alloy. In another non-limiting embodiment, at least 30% by weight (e.g., 30% by weight-100% by weight and all values ​​and ranges therebetween) of the refractory metal alloy contains one or more of molybdenum, rhenium, niobium, tantalum, or tungsten.

[0102] According to another and / or alternative non-limiting aspect of the present disclosure, a refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium for forming 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 properties, reduced springback, radiopacity, thermal sensitivity, biocompatibility, improved fatigue life, crack resistance, crack growth resistance, reduced magnetic susceptibility, etc.), improved conformability when bent, less springback, 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 metal component thickness, improved bone fusion and / or lower ion release into tissue. These one or more enhanced physical properties of the refractory metal alloy or the metal alloy containing at least 15 awt.% rhenium can be achieved in a medical device or a portion of a medical device (e.g., a frame of a medical device, etc.) without having to increase the bulk, volume and / or weight of the medical device or a portion of a medical device (e.g., a frame of a medical device, etc.), and in some cases, these enhanced physical properties can be achieved even when the bulk, volume and / or weight of the medical device or a portion of a medical device (e.g., a frame of a medical device, etc.) is reduced compared to a medical device or a frame of a medical device formed at least in part from conventional stainless steel, titanium alloys, or cobalt and chromium alloy materials.The reduced springback, improved flexural conformity, and greater radial strength of an expandable frame formed at least in part from a refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium compared to expandable frames formed from stainless steel, CoCr alloys, and TiAlV alloys result in one or more of the following non-limiting advantages: 1) the formation of a medical device frame having thinner posts, struts, and / or strut joints, which results in i) safer vascular access when inserting the medical device through a body passage and into a treatment area, and / or ii) safer vascular access when the medical device is delivered to the treatment area and / or or reduced risk of bleeding and / or damage to the body passage and / or treatment area when expanded at the treatment area; 2) easier delivery of the medical device to the treatment area, which can result in: i) reduced trauma to the body passage (e.g., blood vessel, aortic arch trauma, etc.) during insertion and / or expansion of the medical device at the treatment area, and / or ii) reduced risk of neurological complications (stroke); 3) less recoil, which results in: i) a reduction in the size of the curled profile, ii) greater flexibility of the expanded medical device at the treatment area after expansion while located in the treatment area. The invention provides for the following advantages: the advantages of the present invention are as follows: (i) an increase in conformability, ii) an increase in radial strength of the frame of the medical device after expansion at the treatment area, iii) an increase in radial strength of the frame of the medical device after expansion at the treatment area, iv) only a single crimping cycle is required to crimp the medical device onto a balloon catheter or other type of delivery device, v) a reduction in the incidence of damage to components of the medical device (e.g., struts, posts, strut joints and / or other components of the expandable frame, leaflets, skirts, coatings, etc.) during crimping, expansion and operation of the medical device, vi) a larger effective orifice area (EOA) of the medical device after expansion of the medical device, and vi) a greater degree of flexibility of the medical device when the medical device is expanded in the treatment area. and / or 4) producing a medical device having the following superior material biological properties: I) improved tissue adhesion and / or growth on or around the medical device, II) reduced adverse tissue reactions with the medical device, III) reduced toxicity of the medical device, IV) reduced potential for intravalvular thrombosis during the life of the medical device, and / or V) reduced incidence of infection during the life of the medical device.

[0103] According to another and / or alternative non-limiting aspect of the present disclosure, a refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium used to at least partially form a medical device or a portion of a medical device (e.g., a frame of a medical device, etc.) can thus: 1) increase the radiopacity of the medical device or a portion of a medical device (e.g., a frame of a medical device, etc.), 2) increase the radial strength of the medical device or a portion of a medical device (e.g., a frame of a medical device, etc.), 3) increase the yield strength and / or ultimate tensile strength of the medical device or a portion of a medical device (e.g., a frame of a medical device, etc.), 4) improve the stress-strain properties of the medical device or a portion of a medical device (e.g., a frame of a medical device, etc.), 5) improve the mechanical properties of the medical device or a portion of a medical device (e.g., a frame of a medical device, etc.), or a portion of a medical device (e.g., a frame of a medical device, etc.), 6) improving the bendability and / or flexibility of a medical device or a portion of a medical device (e.g., a frame of a medical device, etc.), 7) improving the strength and / or durability of a medical device or a portion of a medical device (e.g., a frame of a medical device, etc.), 8) increasing the hardness of a medical device or a portion of a medical device (e.g., a frame of a medical device, etc.), 9) improving the resilience of a medical device or a portion of a medical device (e.g., a frame of a medical device, etc.), 10) improving the biostability and / or biocompatibility of a medical device or a portion of a medical device (e.g., a frame of a medical device, etc.), 11) increasing the biocompatibility of a medical device or a portion of a medical device (e.g., a frame of a medical device, etc.), , medical device frame, etc.), 12) resist cracking in a medical device or a portion of a medical device (e.g., a medical device frame, etc.) and resist crack propagation, 13) enable a smaller, thinner and / or lighter medical device or a portion of a medical device (e.g., a medical device frame, etc.), 14) reduce the outer diameter of a curled medical device or a portion of a medical device (e.g., a medical device frame, etc.), 15) improve the conformability of the medical device or a portion of a medical device (e.g., a medical device frame, etc.) to the shape of a treatment area when the medical device or a portion of a medical device (e.g., a medical device frame, etc.) is used and / or expanded in the treatment area, 16) reduce the size of the medical device or a portion of a medical device (e.g., a medical device frame, etc.) for example, a medical device frame, etc.) to increase the amount by which a medical device or a portion of a medical device (e.g., a medical device frame, etc.) rebounds to the shape of a treatment area when the medical device or a portion of a medical device (e.g., a medical device frame, etc.) is expanded in the treatment area, 17) increasing the yield strength of a medical device or a portion of a medical device (e.g., a medical device frame, etc.), 18) improving the fatigue ductility of a medical device or a portion of a medical device (e.g., a medical device frame, etc.), 18) improving the durability of a medical device or a portion of a medical device (e.g., a medical device frame, etc.), 19) improving the fatigue life of a medical device or a portion of a medical device (e.g., a medical device frame, etc.), 20) reducing adverse tissue reactions after implantation of a medical device or a portion of a medical device (e.g., a medical device frame, etc.),21) reducing the release of metal ions after the implantation of a medical device or a portion of a medical device (e.g., a frame of a medical device, etc.), 22) reducing the corrosion of a medical device or a portion of a medical device (e.g., a frame of a medical device, etc.) after the implantation of a medical device or a portion of a medical device (e.g., a frame of a medical device, etc.), 23) reducing the allergic reaction after the implantation of a medical device or a portion of a medical device (e.g., a frame of a medical device, etc.), 24) improving the hydrophilicity of a medical device or a portion of a medical device (e.g., a frame of a medical device, etc.), 25) reducing the hydrophilicity of a medical device or a portion of a medical device (e.g., a frame of a medical device, etc.), 26) improving bone fusion with the medical device or portion of the medical device (e.g., the frame of the medical device, etc.), and / or 27) reducing ion release from the medical device or portion of the medical device (e.g., the frame of the medical device, etc.) into tissue, 28) reducing the magnetic susceptibility of the medical device or portion of the medical device (e.g., the frame of the medical device, etc.) when implanted in a patient, and / or 29) reducing the toxicity of the medical device or portion of the medical device (e.g., the frame of the medical device, etc.) after prosthetic medical device implantation.

[0104] According to another and / or alternative non-limiting aspect of the present disclosure, the medical device or a portion of the medical device (e.g., a frame of a medical device, etc.) is optionally subjected to one or more manufacturing processes. These manufacturing processes may include, but are not limited to, expansion, laser cutting, planing, core drawing, etching (chemical etching, plasma etching, etc.), curling, photoetching, coating, annealing, centerless grinding, turning, drawing, pilger tube rolling, electroplating, polishing, electropolishing, machining, plasma coating, 3D printing, 3D printing coating, cold working, drilling (e.g., gun drilling, etc.), chemical vapor deposition, chemical polishing, cleaning, polishing, smoothing, pickling, ion beam deposition or implantation, sputter coating, vacuum deposition, die forging, nitriding, annealing, EDM cutting, microelectromechanical manufacturing (MEMS) technology [e.g., micromachining, laser micromachining, laser micromachining, etc.], etc. In a non-limiting embodiment, the medical device is optionally subjected to a die forging process. The die forging operation can be performed on the medical device in the area to be hardened. In one non-limiting arrangement, if the die forging is performed in air or an oxidizing environment, the die forging temperature can be from room temperature (RT) (e.g., 10°C-27°C and all values ​​and ranges therebetween) to about 400°C (e.g., 10°C-400°C and all values ​​and ranges therebetween). If the die forging process is performed in a controlled neutral or non-reducing environment (e.g., an inert environment), the die forging temperature can be increased to up to about 1500°C (e.g., 10°C-1500°C and all values ​​and ranges therebetween). During the die forging process, ions of boron and / or nitrogen can optionally impact 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 (and all values ​​and ranges therebetween). Typically, the weight percentage of nitrogen in the nitrided surface layer is 0.0001% by weight-5% by weight nitrogen (and all values ​​and ranges therebetween). Typically, the weight percentage of nitrogen in the nitrided surface layer is typically less than at least one and typically all major components of the metal alloy (e.g., the major component is an alloy component greater than 5% by weight that constitutes the metal alloy). The nitriding process of the metal alloy can be used to increase the surface hardness and / or wear resistance of the metal alloy, increase the surface smoothness or lubricity of the metal alloy and / or inhibit or prevent the discoloration of the metal alloy (e.g., discoloration due to oxidation, etc.). In another non-limiting embodiment, the metal alloy can be optionally nitrided before and / or after at least one drawing step and / or annealing step of the metal alloy.

[0105] According to another and / or alternative non-limiting aspect of the present disclosure, a refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium used to at least partially form a medical device or a portion of a medical device (e.g., a frame of a medical device, etc.) optionally has a substantially uniform density throughout the refractory metal alloy or the metal alloy containing at least 15 awt.% rhenium, and also results in a desired yield strength and ultimate tensile strength of the refractory metal alloy or the metal alloy containing at least 15 awt.% rhenium. The density of the refractory metal alloy or the metal alloy containing at least 15 awt.% rhenium is generally at least about 5 gm / cc (e.g., 5 gm / cc-21 gm / cc and all values ​​and ranges therebetween; 10 gm / cc-20 gm / cc; etc.), and typically is at least about 11 gm / cc-19 gm / cc. This substantially uniform high density of the refractory metal alloy or the metal alloy comprising at least 15 awt. % rhenium may optionally increase the radiopacity of the refractory metal alloy or the metal alloy comprising at least 15 awt. % rhenium.

[0106] In another and / or alternative non-limiting aspect of the present disclosure, a refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium used to form all or a portion of a medical device: 1) is optionally not clad, metal sprayed, electroplated and / or formed (e.g., cold worked, hot worked, etc.) onto another metal, or 2) optionally does not have another metal or metal alloy metal sprayed, plated, clad and / or formed onto the refractory metal alloy or the metal alloy containing at least 15 awt.% rhenium.

[0107] According to another and / or alternative non-limiting aspect of the present disclosure, a refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium used to form all or a portion of a medical device: 1) is clad, metal sprayed, electroplated and / or formed (e.g., cold worked, hot worked, etc.) onto another metal, or 2) has another metal or metal alloy metal sprayed, plated, clad and / or formed onto the refractory metal alloy or the metal alloy containing at least 15 awt.% rhenium.

[0108] According to another and / or alternative non-limiting aspect of the present disclosure, a medical device or a portion 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 a metal alloy containing at least 15 awt.% rhenium, or formed into a shape that is at least 80% of the final net shape of the medical device or a portion of a medical device (e.g., a frame of a medical device, etc.).

[0109] According to another and / or alternative non-limiting aspect of the present disclosure, a refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium has several physical properties that positively affect the medical device when the medical device is at least partially formed from the refractory metal alloy or the metal alloy containing at least 15 awt.% rhenium. In one non-limiting embodiment of the present disclosure, the refractory metal alloy or the metal alloy containing at least 15 awt.% rhenium used to at least partially form a medical device or a portion of a medical device (e.g., a frame of a medical device, etc.) optionally has an average Vickers hardness of at least about 150 Vickers (e.g., 150 Vickers-300 Vickers and all values ​​and ranges therebetween); and typically 160 Vickers-240 Vickers; however, this is not required. The refractory metal alloy or the metal alloy containing at least 15 awt.% rhenium generally has an average hardness greater than that of stainless steel (e.g., Grade 304, Grade 316). In another and / or alternative non-limiting embodiment of the present disclosure, the refractory metal alloy or the metal alloy containing at least 15 awt.% rhenium optionally has an average ultimate tensile strength of at least about 100 ksi (e.g., 100 ksi-350 ksi and all values ​​and ranges therebetween); however, this is not required. In yet another and / or alternative non-limiting embodiment of the present disclosure, the refractory metal alloy or the metal alloy containing at least 15 awt.% rhenium optionally has an average yield strength of at least about 80 ksi (e.g., 80 ksi-300 ksi and all values ​​and ranges therebetween); however, this is not required. In yet another and / or alternative non-limiting embodiment of the present disclosure, a refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium used to at least partially form a medical device or a portion of a medical device (e.g., a frame of a medical device, etc.) optionally has an average grain size of no greater than about 4 ASTM (e.g., 4 ASTM to 20 ASTM using ASTM E112 and all values ​​and ranges therebetween (e.g., 0.35 microns to 90 microns and all values ​​and ranges therebetween)). The small grain size of the refractory metal alloy or the metal alloy containing at least 15 awt.% rhenium enables the medical device or a portion of a medical device (e.g., a frame of a medical device, etc.) to have desirable elongation and ductility properties that can be used to enable the medical device or a portion of a medical device (e.g., a frame of a medical device, etc.) to be formed, curled and / or expanded.

[0110] In another and / or alternative non-limiting embodiment of the present disclosure, a refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium used to at least partially form a medical device or a portion of a medical device (e.g., a frame of a medical device, etc.) optionally has an average tensile elongation of at least about 25% (e.g., 25%-50% average tensile elongation and all values ​​and ranges therebetween). The average tensile elongation of at least 25% for the refractory metal alloy or the metal alloy containing at least 15 awt.% rhenium can be used to facilitate the medical device or a portion of a medical device (e.g., a frame of a medical device, etc.) to be properly expanded when positioned in a treatment area of ​​a body passage. A medical device or a frame of a medical device formed partially or completely from a material that does not have an average tensile elongation of at least about 25% may be more susceptible to microcracks and / or fractures during the forming, curling and / or expansion of the medical device or a portion of a medical device (e.g., a frame of a medical device, etc.).

[0111] According to another and / or alternative non-limiting aspect of the present disclosure, the medical device may optionally comprise, contain and / or be coated with one or more formulations that promote the success of the medical device and / or treatment area. The term "formulation" includes, but is not limited to, substances, drugs, biologics, veterinary products, pharmaceuticals, and analogs or derivatives that are otherwise formulated and / or designed to prevent, inhibit and / or treat one or more clinical and / or biological events and / or to promote healing. Non-limiting examples of clinical events that may be addressed by one or more formulations include, but are not limited to, viral, fungal and / or bacterial infections; vascular diseases and / or conditions; digestive diseases and / or disorders; reproductive diseases and / or disorders; lymphatic diseases and / or conditions; cancer; implant rejection; pain; nausea; swelling; arthritis; bone diseases and / or conditions; organ failure; immune diseases and / or disorders; cholesterol problems; blood diseases and / or conditions; lung diseases and / or conditions; heart diseases and / or conditions; brain diseases and / or conditions; neuropathic pain diseases and / or conditions; kidney diseases and / or diseases Diseases and / or disorders of the liver; diseases and / or disorders of the intestine; diseases and / or disorders of the gallbladder; diseases and / or disorders of the pancreas; psychological disorders; diseases and / or disorders of the respiratory tract; diseases and / or disorders of the glands; diseases and / or disorders of the skin; diseases and / or disorders of the hearing; diseases and / or disorders of the oral cavity; diseases and / or disorders of the nose; diseases and / or disorders of the eye; fatigue; genetic diseases and / or disorders; burns; scars and / or scars; trauma; weight diseases and / or disorders; addiction diseases and / or disorders; hair loss; cramps; muscle spasms; tissue repair; nerve repair; nerve regeneration, etc. The type and / or amount of the formulation included in and / or coated on the medical device may vary. When two or more formulations are included in and / or coated on the medical device, the amounts of the two or more formulations may be the same or different. The type and / or amount of the formulation included on, in and / or in conjunction with the medical device is generally selected to address one or more clinical events. When a formulation is used, the amount of the formulation contained on, in, and / or used in conjunction with a medical device is about 0.01 ug / mm2-100 ug / mm2 (and all values ​​and ranges therebetween) and / or at least about 0.00001% by weight of the medical device; however, other amounts may be used. The amounts of two or more formulations used on, in, and / or used in conjunction with a medical device may be the same or different. One or more formulations may be applied to and / or impregnated into a medical device by a variety of mechanisms, such as, but not limited to, spraying (e.g., atomizing spray techniques, etc.), flame spraying, powder deposition, dip coating, flow coating, dip spin coating, roller coating (direct and reverse), ultrasonic treatment, brush coating, plasma deposition, deposition by vapor deposition, MEMS technology, and spin mold deposition.When using two or more preparations, the amount of two or more preparations used in combination with medical device, in medical device and / or in medical device can be the same or different.Medical device can be configured to make: 1) all preparations on medical device and / or in medical device be controllably released, 2) some preparations on medical device and / or in medical device be controllably released, and some preparations are non-controllably released, or 3) preparations on medical device and / or in medical device are not controllably released.Medical device can also be designed so that one or more preparations are the same or different from the release rate of medical device.Medical device can also be designed so that one or more preparations are the same or different from the release rate of one or more zones on medical device. Non-limiting arrangements that can be used to control the release of one or more agents from a medical device include: 1) at least partially coating one or more agents with one or more polymers, 2) at least partially incorporating and / or at least partially encapsulating one or more agents into one or more polymers, and / or at least partially incorporating and / or at least partially encapsulating one or more agents with one or more polymers, and / or 3) inserting one or more agents into a hole, channel, cavity, etc. in a medical device and at least partially coating or covering such hole, channel, cavity, etc. with one or more polymers. As will be appreciated, other or additional arrangements can be used to control the release of one or more agents from a medical device. When used, the thickness of each polymer layer and / or agent layer is typically at least about 0.01 μm and typically less than about 150 μm (e.g., 0.01 μm-149.9999 μm and all values ​​and ranges therebetween).

[0112] According to another and / or alternative non-limiting aspect of the present disclosure, the medical device may optionally include a marker material that facilitates enabling the medical device to be correctly 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., ultrasound, etc.); magnetic waves (e.g., MRI, etc.); and / or other types of electromagnetic waves (e.g., microwaves, visible light, infrared waves, ultraviolet waves, etc.). In a non-limiting embodiment, the marker material is visible to X-rays (i.e., radiopaque). The marker material may form all or part of the medical device and / or be coated on one or more parts of the medical device. The location of the marker material may be located at one or more locations on the medical device.

[0113] According to another and / or alternative non-limiting aspect of the present disclosure, the medical device is a device that is expandable through the use of some other device (eg, a balloon, etc.).

[0114] According to another and / or alternative non-limiting aspect of the present disclosure, the medical device is made of a material having no or substantially no shape memory properties.

[0115] According to another and / or alternative non-limiting aspect of the present disclosure, net parts, billets, rods, tubes, etc. for partially or completely forming medical devices can be formed by various techniques, such as but not limited to: 1) melting the metal alloy and / or the metal forming the metal alloy (for example, vacuum arc melting, etc.), and then extruding and / or casting the metal alloy into a near-net part, billet, rod, tube, etc., 2) melting the metal alloy and / or the metal forming the metal alloy to form a metal strip, and then rolling and welding the strip into a near-net part, billet, rod, tube, etc., 3) consolidating (pressing, pressing and sintering, etc.) the metal powder of the metal alloy and / or the metal powder of the metal that forms the metal alloy into a near-net part, billet, rod, tube, etc., and / or 4) 3D printing the metal alloy into a near-net part, billet, rod, tube, etc.

[0116] According to another and / or alternative non-limiting aspect of the present disclosure, a near-net process for medical devices is optionally provided. In a non-limiting embodiment of the present disclosure, a method for pressing a powder material and optionally increasing the strength after sintering by imparting additional cold working is provided. In a non-limiting embodiment, the green part is pressed and then sintered. Thereafter, the sintered part is pressed again to increase its mechanical strength by imparting cold working to the pressed and sintered part. Typically, the temperature during the pressing process after the sintering process is 20°C-100°C (and all values ​​and ranges therebetween), typically 20°C-80°C, and more typically 20°C-40°C. As defined herein, cold working is performed at a temperature not exceeding 150°C (e.g., 10°C-150°C and all values ​​and ranges therebetween). It is necessary to determine the change in the shape of the re-pressed sintered part so that the final part (pressed, sintered and re-pressed) meets the dimensional requirements of the final formed part. A pre-pressing pressure of 1 tsi (1 ton per square inch) - 300 tsi (and all values ​​and ranges therebetween) can be used, followed by a sintering process of at least 1600°C (e.g., 1600°C - 2600°C and all values ​​and ranges therebetween) and a post-sintering press at a pressure of 1 tsi - 300 tsi (and all values ​​and ranges therebetween) at a temperature of at least 20°C (e.g., 20°C - 100°C and all values ​​and ranges therebetween; 20°C - 40°C, etc.).

[0117] According to another and / or alternative non-limiting aspect of the present disclosure, a press for a near-net or finished part composite material for a medical device including the use of a degradable polymer is optionally provided. The process includes pressing a composite structure formed of a metal powder and a polymer for the purpose of manufacturing complex part geometries and foam-like structures. When the pressed part is sintered, the polymer is partially or completely removed by a thermal degradation process of the polymer. The resulting part has a porosity associated with the size of the polymer particles and the homogeneity of the mixture when pressed before sintering. Typically, the polymer accounts for about 0.1 vol.%-70 vol.% (and all values ​​and ranges therebetween) of the consolidated and pressed material before the sintering step.

[0118] According to another and / or alternative non-limiting aspect of the present disclosure, the medical device may optionally include one or more surface structures (e.g., holes, channels, pits, ribs, slots, notches, bumps, teeth, needles, wells, holes, grooves, etc.). These structures may be formed at least in part by MEMS (e.g., micromachining, etc.) technology and / or other types of technology (e.g., 3D printing). According to a non-limiting embodiment, the medical device may optionally include one or more microstructures (e.g., microneedles, micropores, micropillars, microcones, micropyramids, microtubes, microparallelepipeds, microprisms, microhemispheres, teeth, ribs, ridges, ratchets, hinges, zippers, cable tie-like structures, etc.) located 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.) not exceeding about 2 mm, and typically not exceeding about 1 mm. As can be understood, when the 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 structure can be a microstructure and a portion can be a non-microstructure. Non-limiting examples of structures that can be formed on medical devices are shown in U.S. Patent Publication Nos. 2004 / 0093076 and 2004 / 0093077, which are incorporated herein by reference. Typically, the microstructure (when formed) extends from or into the outer surface no more than about 400 microns (0.01-400 microns and all values ​​and ranges therebetween) and more typically less than about 300 microns, and more typically about 15-250 microns; however, other sizes can be used. In another non-limiting embodiment, one or more surface structures and / or microstructures can be at least partially formed by a formulation and / or formed by a polymer. One or more of the surface structures and / or microstructures may include one or more internal channels, which may include one or more materials (eg, agents, polymers, etc.); however, this is not required.

[0119] According to another and / or alternative non-limiting aspect of the present disclosure, the medical device may optionally be an expandable device that may be expanded through the use of some other device (eg, a balloon, etc.).

[0120] According to another and / or alternative non-limiting aspect of the present disclosure, the medical device may optionally be made of a material having no or substantially no shape memory properties.

[0121] According to another and / or alternative non-limiting aspect of the present disclosure, a near-net process for a frame and / or other metal parts of a medical device is optionally provided. In a non-limiting embodiment of the present disclosure, a method for pressing a powder material and optionally increasing the strength after sintering by imparting additional cold working is provided. In a non-limiting embodiment, the green part is pressed and then sintered. Thereafter, the sintered part is pressed again to increase its mechanical strength by imparting cold working to the pressed and sintered part. Typically, the temperature during the pressing process after the sintering process is 20°C-100°C (and all values ​​and ranges therebetween), typically 20°C-80°C, and more typically 20°C-40°C. As defined herein, cold working is performed at a temperature not exceeding 150°C (e.g., 10°C-150°C and all values ​​and ranges therebetween). It is necessary to determine the change in the shape of the re-pressed sintered part so that the final part (pressed, sintered and re-pressed) meets the dimensional requirements of the final formed part. For Mo47.5Re alloys, MoRe alloys, ReW alloys, molybdenum alloys, tungsten alloys, rhenium alloys, other refractory metal alloys, or other metal alloys containing at least 15 awt.% rhenium, a pre-pressing pressure of 1 tsi (1 ton per square inch)-300 tsi (and all values ​​and ranges therebetween) can be used, followed by a sintering process of at least 1600°C (e.g., 1600°C-2600°C and all values ​​and ranges therebetween) and a post-sintering press at a pressure of 1 tsi-300 tsi (and all values ​​and ranges therebetween) at a temperature of at least 20°C (e.g., 20°C-100°C and all values ​​and ranges therebetween; 20°C-40°C, etc.). An optional process is also provided for increasing the mechanical strength of the pressed metal part by pressing the post-sintered part to add additional cold work to the material to increase its mechanical strength. An optional process is also provided for using metal powder to press the powder into a near-net or final part. In one non-limiting embodiment, the metal powder used to form a near-net or final part contains a minimum of 40 wt% rhenium and at least 25 wt% molybdenum, and the remainder 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 a near-net or final part contains 20 wt%-80 wt% rhenium (and all values ​​and ranges therebetween), 20 wt%-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 a near-net or final part contains tungsten (20 wt%-60 wt% and all values ​​and ranges therebetween), rhenium (20 wt%-80 wt% and all values ​​and ranges therebetween), and one or more other elements (0 wt%-5 wt% and all values ​​and ranges therebetween).In another non-limiting embodiment, the metal powder used to form a near-net or final part comprises tungsten (20 wt%-80 wt% and all values ​​and ranges therebetween), rhenium (20 wt%-80 wt% and all values ​​and ranges therebetween), molybdenum (0.01 wt%-15 wt% and all values ​​and ranges therebetween), and one or more other elements (0 wt%-5 wt% and all values ​​and ranges therebetween). In another non-limiting embodiment, the metal powder used to form a near-net or final part comprises tungsten (20 wt%-80 wt% and all values ​​and ranges therebetween), copper (1 wt%-30 wt% and all values ​​and ranges therebetween), and one or more other elements (0 wt%-5 wt% and all values ​​and ranges therebetween). In another non-limiting embodiment, the metal powder used to form a near-net or final part comprises 35 wt%-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 a near-net or final part comprises a combination of 35 wt%-65 wt% rhenium (and all values ​​and ranges therebetween) molybdenum powder and 11 wt%-41 wt% (and all values ​​and ranges therebetween) chromium powder and optionally one or more metal powders 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 a near-net or final part comprises 35 wt%-65 wt% rhenium (and all values ​​and ranges therebetween) and chromium, and 0.1 wt%-25 wt% rhenium (and all values ​​and ranges therebetween) and one or more elements of the following: 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% by weight rhenium (and all values ​​and ranges therebetween), and one or more of 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 alloys of one or more of such ingredients.

[0122] According to another and / or alternative non-limiting aspect of the present disclosure, a press for a near-net or finished part composite is optionally provided. The process of pressing metals into near-net or finished parts is well established; however, pressing composite structures formed of metal powders and polymers for the purpose of manufacturing complex part geometries and foam-like structures is new. Similarly, the use of a pressing process to impart specific biological substances to a metal matrix is ​​also new. In one non-limiting embodiment, a process for creating a metal part with predefined voids to create a trabecular or foam structure is provided, the process consisting of the following steps: mixing metal and polymer powders, and then pressing the powders into a finished part or a semi-finished green part, and then sintering the part under conditions where the polymer leaves the metal through a thermal degradation process of the polymer. The resulting part has a porosity associated with the size of the polymer particles and the homogeneity of the mixture when pressed before sintering. In another non-limiting embodiment, a process is provided by which a polymer residue is left (on a metal substrate) after thermal degradation, and the polymer residue has some desired biological effects (e.g., by encapsulating, promoting cell attachment and growth to cover the metal from the body). The polymer and metal powders can be of different sizes to create multiple voids—some large voids to create pathways for cell growth, and some small voids to create a wrinkled surface to promote cell attachment.

[0123] According to another and / or alternative non-limiting aspect of the present disclosure, when the refractory metal alloy or the metal alloy containing at least 15 awt.% rhenium is formed into a billet, the shape and size of the billet are non-limiting. When the refractory metal alloy or the metal alloy containing at least 15 awt.% rhenium is formed into a rod or tube, the rod or tube typically has a length of about 48 inches or less (e.g., 0.1 inches-48 inches and all values ​​and ranges therebetween); however, longer lengths can be formed. In one non-limiting arrangement, the length of the rod or tube is about 8 inches-20 inches. The average outer diameter of the rod or tube is typically less than about 2 inches (i.e., less than about 3.14 square inches of cross-sectional area), more typically less than about 1 inch outer diameter, and even more typically no more than about 0.5 inches outer diameter; however, larger rod or tube diameter sizes can 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 appreciated, this is just one example of many different sizes of tubes that can be formed. In one non-limiting process, a near-net frame, billet, rod, tube, etc. of a medical device or a portion of a medical device (e.g., a frame of a medical device, etc.). In one non-limiting process, a near-net medical device or a portion of a medical device (e.g., a frame of a medical device, etc.), billet, rod, tube, etc. can be formed from one or more ingots of a metal or a refractory metal alloy or a metal alloy containing at least 15 awt.% 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 a portion of a medical device (e.g., a frame of a medical device, etc.), billet, rod, tube, etc. In another non-limiting process, rhenium powder and tungsten powder and optionally molybdenum powder can be placed in a crucible (e.g., a silica crucible, etc.) and heated by an induction 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 portion of a medical device (e.g., a frame of a medical device, etc.), a billet, a rod, a tube, etc. As can be appreciated, other metal particles can be used to form other refractory metal alloys or metal alloys containing at least 15 awt.% 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.) through various processes such as melting, sintering, particle compression plus heating. It can be appreciated that other or additional processes can be used to form refractory metal alloys or metal alloys containing at least 15 awt.% rhenium.When a tube of a refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium is to be formed, a close-fitting rod may be used to form the tube during the extrusion process; however, this is not required. In another and / or additional non-limiting process, a tube of a refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium may be formed from a strip or sheet of the refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium. The strip or sheet of the refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium may be formed into a tube by rolling the edges of the sheet or strip and then welding the edges of the sheet or strip together. Welding of the edges of the sheet or strip can be accomplished in several ways, such as, but not limited to, a) holding the edges together and then electron beam welding the edges together in a vacuum, b) placing a thin strip of a refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium over and / or under the edges of the rolled strip or sheet to be welded, then welding one or more strips along the edges of the rolled strip or sheet, and then grinding off the outer strips, or c) laser welding the edges of the rolled sheet or strip in a vacuum, oxygen reducing atmosphere, or inert atmosphere. In yet another and / or additional non-limiting process, a near-net frame, billet, rod, tube, etc. of a medical device or portion of a medical device (e.g., a frame of a medical device, etc.) of a refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium is formed by consolidating metal powders. 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 homogenous particle blend. Typically, the average particle size of the metal powder is less than about 200 mesh (e.g., less than 74 microns; 2 microns-74 microns and all values ​​and ranges therebetween). Larger average particle sizes may interfere with proper mixing of the metal powder and / or adversely affect one or more physical properties of a near-net frame, billet, rod, tube, etc. of a medical device or portion of a medical device (e.g., a frame of a medical device, 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 microns-63 microns, and more specifically about 5 microns-40 microns. As can be appreciated, smaller average particle sizes may be used. The purity of the metal powder should be selected so that the metal powder contains very low carbon, oxygen, and nitrogen content. Typically, the metal powder used to form a refractory metal alloy or a metal alloy containing at least 15 awt% rhenium has a carbon content of less than about 100 ppm, an oxygen content of less than about 50 ppm, and a nitrogen content of less than about 20 ppm. Typically, the metal powder used to form the refractory metal alloy or the metal alloy containing at least 15 awt% rhenium has a purity grade of at least 99.9 and more typically at least about 99.95.The blend of metal powders is then pressed together to form a solid solution of the refractory metal alloy or metal alloy containing at least 15 awt.% rhenium into a near-net medical device or portion of a medical device (e.g., a frame of a medical device), a billet, a rod, a tube, etc. Typically, the pressing process employs an isostatic pressing process (i.e., uniform pressure is applied to the metal powders from all directions); however, other processes may be used. When the metal powders are pressed together in an isostatic manner, cold isostatic pressing (CIP) is typically used to consolidate the metal powders; however, this is not required. The pressing process may be performed in an inert atmosphere, an oxygen reducing atmosphere (e.g., hydrogen, argon and hydrogen mixtures, etc.), and / or under vacuum; however, this is not required. The average density of the near-net medical device or portion of a medical device (e.g., a frame of a medical device, etc.), billet, rod, tube, etc. achieved by pressing the metal powders together is about 80%-95% (and all values ​​and ranges therebetween) of the final average density of the near-net medical device or portion of a medical device (e.g., a frame of a medical device, etc.), billet, rod, tube, etc., or about 70%-99% (and all values ​​and ranges therebetween) of the minimum theoretical density of the refractory metal alloy or metal alloy containing at least 15 awt.% rhenium. A pressing pressure of at least about 300 MPa (e.g., 300 MPa-800 MPa and all values ​​and ranges therebetween) is typically used. Typically, the pressing pressure is about 400 MPa-700 MPa; however, other pressures may 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° C.-3500° C. and all values ​​and ranges therebetween) to partially or completely fuse the metal powders together to form a near-net medical device or a portion of a medical device (e.g., a frame of a medical device, etc.), a billet, a rod, a tube, etc. The sintering of the consolidated metal powders can be performed in an oxygen reducing atmosphere (e.g., helium, argon, hydrogen, a mixture of argon and hydrogen, etc.) and / or under vacuum; however, this is not required. At high sintering temperatures, a high hydrogen atmosphere will reduce the amount of both carbon and oxygen in the formed near-net medical device or a portion of a medical device (e.g., a frame of a medical device, etc.), a billet, a rod, a tube, etc. The sintered metal powders typically have a sintered average density of about 90%-99.9% (and all values ​​and ranges therebetween) of the minimum theoretical density of the refractory metal alloy or the metal alloy containing at least 15 awt.% rhenium. Typically, the sintered refractory metal alloy or metal alloy containing at least 15 awt. % rhenium has a final average density of at least about 5 gm / cc (e.g., 5 gm / cc-20 gm / cc and all values ​​and ranges therebetween), and typically at least about 8.3 gm / cc, and may be up to or greater than about 16 gm / cc; however, this is not required.The density of the formed near-net medical device or portion of a medical device (e.g., a medical device frame, etc.), billet, rod, tube, etc. will generally depend on the type of refractory metal alloy or metal alloy containing at least 15 awt. % rhenium used.

[0124] 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 then formed into a tube before reducing the outer cross-sectional area or diameter of the rod. The rod can be formed into a tube by a variety of processes such as, but not limited to, cutting or drilling (e.g., gun drilling, etc.) or by cutting (e.g., EDM, EDM sinker, wire EDM, etc.) or by 3D printing. The cavity or channel formed in the rod is typically formed completely through the rod; however, this is not required.

[0125] In still further and / or alternative non-limiting aspects of the present disclosure, a near-net medical device or portion of a medical device (e.g., a frame of a medical device, etc.), a blank, a rod, a tube, etc., can be re-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 portion of a medical device (e.g., a 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 portion of a medical device (e.g., a frame of a medical device, etc.), a blank, a rod, a tube, etc., in a single step or through a series of steps. The reduction in the outer cross-sectional area or diameter of the near-net medical device or portion of a medical device (e.g., a 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, planing, polishing, EDM cutting, etc. The outer cross-sectional area or diameter of the near-net medical device or portion of a medical device (e.g., a frame of a medical device, etc.), a blank, a rod, a tube, etc. can be reduced by using one or more drawing processes; however, this is not required. During the drawing process, care should be taken not to form microcracks in the near-net medical device or portion of a medical device (e.g., a frame of a medical device, etc.), blank, rod, tube, etc. during the reduction of the outer cross-sectional area or diameter of the near-net medical device or portion of a medical device (e.g., a frame of a medical device, etc.), blank, rod, tube, etc.

[0126] In another and / or alternative non-limiting aspect of the present disclosure, whenever the size of a near-net medical device or a portion of a medical device (e.g., a frame of a medical device, etc.), a billet, a rod, a tube, etc. is reduced, the cross-sectional area of ​​the near-net medical device or a portion of a medical device (e.g., a frame of a medical device, etc.), a billet, a rod, a tube, etc. is typically reduced by more than about 25% (e.g., 0.1%-25% and all values ​​and ranges therebetween). When the near-net medical device or a portion of a medical device (e.g., a frame of a medical device, etc.), a billet, a rod, a tube, etc. optionally includes a nitride layer, the nitride layer may optionally act as a lubricating surface during the drawing process to facilitate drawing of the near-net medical device or a portion of a medical device (e.g., a frame of a medical device, etc.), a billet, a rod, a tube, etc. Typically, whenever the near-net medical device or a portion of a medical device (e.g., a frame of a medical device, etc.), a billet, a rod, a tube, etc. is drawn through a diameter reduction mechanism, the cross-sectional area of ​​the near-net medical device or a portion of a medical device (e.g., a frame of a medical device, etc.), a billet, a rod, a tube, etc. is reduced by about 0.1%-20%. In another and / or alternative non-limiting process step, each time a nearly net medical device or a portion of a medical device (e.g., a frame of a medical device, etc.), a blank, a rod, a tube, etc. is drawn through a diameter reducing mechanism, the cross-section of the nearly net medical device or a portion of a medical device (e.g., a frame of a medical device, etc.), a blank, a rod, a tube, etc. is reduced by about 1%-15%. In yet another and / or alternative non-limiting process step, each time a nearly net medical device or a portion of a medical device (e.g., a frame of a medical device, etc.), a blank, a rod, a tube, etc. is drawn through a diameter reducing mechanism, the cross-section of the nearly net medical device or a portion of a medical device (e.g., a frame of a medical device, etc.), a blank, a rod, a tube, etc. is reduced by about 2%-15%. In yet another non-limiting process step, each time a nearly net medical device or a portion of a medical device (e.g., a frame of a medical device, etc.), a blank, a rod, a tube, etc. is drawn through a diameter reducing mechanism, the cross-section of the nearly net medical device or a portion of a medical device (e.g., a 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 portion of a medical device (e.g., a frame of a medical device, etc.), billet, rod, tube, etc. of a refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium is drawn through a die to reduce the cross-sectional area of ​​the near-net medical device or portion of a medical device (e.g., a frame of a medical device, etc.), billet, rod, tube, etc. Typically, one end of the near-net medical device or portion of a medical device (e.g., a frame of a medical device, etc.), billet, rod, tube, etc. is narrowed (nose-tipped) prior to drawing the near-net medical device or portion of a medical device (e.g., a frame of a medical device, etc.), billet, rod, tube, etc. through the die to allow it to be fed through the die; however, this is not required. The tube drawing process is typically a cold drawing process through a die or a core drawing process.When a cold drawing or mandrel drawing process is used, a lubricant (e.g., molybdenum paste, grease, etc.) is typically applied to the outer surface of the near-clean medical device or portion of a medical device (e.g., a frame of a medical device, etc.), billet, rod, tube, etc., and then the near-clean medical device or portion of a medical device (e.g., a frame of a medical device, etc.), billet, rod, tube, etc. is drawn through a die. Typically, little or no heat is used during the cold drawing process. After the near-clean medical device or portion of a medical device (e.g., a frame of a medical device, etc.), billet, rod, tube, etc. has been drawn through a die, the outer surface of the near-clean medical device or portion of a medical device (e.g., a frame of a medical device, etc.), billet, rod, tube, etc. is typically cleaned with a solvent to remove the lubricant in order to limit the amount of impurities incorporated into the refractory metal alloy or the metal alloy containing at least 15 awt.% rhenium; however, this is not required. The cold drawing process may be repeated several times until a desired outer cross-sectional area or diameter, inner cross-sectional area or diameter, and / or wall thickness of a near-net medical device or portion of a medical device (e.g., a frame of a medical device, etc.), billet, rod, tube, etc. is achieved. A mandrel drawing process may also or alternatively be used to size a near-net medical device or portion of a medical device (e.g., a frame of a medical device, etc.), billet, rod, tube, etc. A mandrel drawing process typically does not use a lubricant during the drawing process. A mandrel drawing process typically includes a heating step to heat the near-net medical device or portion of a medical device (e.g., a frame of a medical device, etc.), billet, rod, tube, etc. prior to and / or during drawing the near-net medical device or portion of a medical device (e.g., a frame of a medical device, etc.), billet, rod, tube, etc. through a die. Eliminating the use of a lubricant may reduce the incidence of impurities being introduced into the refractory metal alloy or the metal alloy containing at least 15 awt.% rhenium during the drawing process. During the core drawing process, the near-clean medical device or portion of a medical device (e.g., a frame of a medical device, etc.), blank, rod, tube, etc. may be protected from oxygen by using a vacuum environment, a non-oxygen environment (e.g., hydrogen, a mixture of argon and hydrogen, nitrogen, nitrogen and hydrogen, etc.), or an inert environment. A non-limiting protective environment includes argon, hydrogen, or argon and hydrogen; however, other or additional inert gases may be used. As indicated above, the near-clean medical device or portion of a medical device (e.g., a frame of a medical device, etc.), blank, rod, tube, etc. is typically cleaned after each drawing process to remove impurities and / or other undesirable materials from the surface of the near-clean medical device or portion of a medical device (e.g., a frame of a medical device, etc.), blank, rod, tube, etc.; however, this is not required.Typically, when the temperature of a near-clean medical device or a portion of a medical device (e.g., a frame of a medical device, etc.), a blank, a rod, a tube, etc. is raised to above 500° C., and typically above 450° C., and more typically above 400° C., the near-clean medical device or a portion of a medical device (e.g., a frame of a medical device, etc.), a blank, a rod, a tube, etc. should be isolated from oxygen and nitrogen; however, this is not required. When a near-clean medical device or a portion of a medical device (e.g., a frame of a medical device, etc.), a blank, a rod, a tube, etc. is heated to a temperature above about 400° C.-500° C., the near-clean medical device, a portion of a medical device (e.g., a frame of a medical device, etc.), a blank, a rod, a tube, etc. tends to begin to form nitrides and / or in the presence of nitrogen and oxygen. In these higher temperature environments, hydrogen environments, argon and hydrogen environments, etc. are commonly used. When a near-net medical device or a portion of a medical device (e.g., a frame of a medical device, etc.), a billet, a rod, a tube, etc. is drawn at a temperature below 400°C-500°C, the near-net medical device or a portion of a medical device (e.g., a frame of a medical device, etc.), a billet, a rod, a tube, etc. can be exposed to air with little or no adverse effect; however, an inert or slightly reducing environment is generally more desirable.

[0127] In another and / or alternative non-limiting aspect of the present disclosure, the near-net medical device or portion of a medical device (e.g., a frame of a medical device, etc.), billet, rod, tube, etc. is cooled after annealing; however, this is not required. Typically, the near-net medical device or portion of a medical device (e.g., a frame of a medical device, etc.), billet, rod, tube, etc. is cooled at a relatively fast rate after annealing to inhibit or prevent the formation of sigma phase in the refractory metal alloy or the metal alloy containing at least 15 awt.% rhenium; however, this is not required. Typically, the near-net medical device or portion of a medical device (e.g., a frame of a medical device, etc.), billet, rod, tube, etc. is cooled at a rate of at least about 50°C per minute after annealing (e.g., 50°C-500°C per minute and all values ​​and ranges therebetween), typically at least about 75°C per minute after annealing, more typically at least about 100°C per minute after annealing, even more typically at least about 100°C-400°C per minute after annealing, even more typically at least about 150°C-350°C per minute after annealing, and yet even more typically at least about 200°C-300°C per minute after annealing, and still even more typically at least about 250°C-280°C per minute after annealing; however, this is not required.

[0128] In another and / or alternative non-limiting aspect of the present disclosure, a near-net medical device or a portion of a medical device (e.g., a frame of a medical device, etc.), a billet, a rod, a tube, etc., is annealed after one or more drawing processes. The refractory metal alloy or a metal alloy billet, a rod, a tube, etc. containing at least 15 awt.% rhenium can be annealed after each drawing process or after multiple drawing processes. The refractory metal alloy or a metal alloy billet, a rod, a tube, etc. containing at least 15 awt.% rhenium is typically annealed before the cross-sectional area size of the refractory metal alloy or a metal alloy billet, a rod, a tube, etc. containing at least 15 awt.% rhenium is reduced by about 60%. In other words, the near-net medical device or a portion of a medical device (e.g., a frame of a medical device, etc.), a billet, a rod, a tube, etc. should not be reduced in cross-sectional area by more than 60% (e.g., 0.1%-60% reduction and all values ​​and ranges therebetween) before annealing. Excessive reduction in the cross-sectional area of ​​the refractory metal alloy or metal alloy containing at least 15 awt.% rhenium billet, rod, tube, etc. during the drawing process before the near-net medical device or portion of a medical device (e.g., a frame of a medical device, etc.), billet, rod, tube, etc. is annealed may result in microscopic cracking of the near-net medical device or portion of a medical device (e.g., a frame of a medical device, etc.), billet, rod, tube, etc. In one non-limiting processing step, the refractory metal alloy or metal alloy containing at least 15 awt.% rhenium billet, rod, tube, etc. is annealed before the cross-sectional area size of the refractory metal alloy or metal alloy containing at least 15 awt.% rhenium billet, rod, tube, etc. is reduced by about 50%. In another and / or alternative non-limiting processing step, the refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium billet, rod, tube, etc. is annealed before the cross-sectional area size of the refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium billet, rod, tube, etc. is reduced by about 45%. According to another and / or alternative non-limiting aspect of the present disclosure, the refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium billet, rod, tube, etc. is annealed before the cross-sectional area size of the refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium billet, rod, tube, etc. is reduced by about 1%-45%. In yet another and / or alternative non-limiting processing step, the refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium billet, rod, tube, etc. is annealed before the cross-sectional area size of the refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium billet, rod, tube, etc. is reduced by about 5%-30%. In yet another and / or alternative non-limiting processing step, the refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium billet, rod, tube, etc. is annealed before the cross-sectional area size of the refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium billet, rod, tube, etc. is reduced by about 5%-15%.

[0129] According to another and / or alternative non-limiting aspect of the present disclosure, when a near-net medical device or a portion of a medical device (e.g., a frame of a medical device, etc.), a blank, a rod, a tube, etc. is annealed, the near-net medical device or a portion of a medical device (e.g., a frame of a medical device, etc.), a blank, a rod, a tube, etc. is typically heated to a temperature of about 500° C. to 1700° C. (and all values ​​and ranges therebetween) for a period of about 1 minute to 200 minutes (and all values ​​and ranges therebetween); however, other temperatures and / or times may be used. In one non-limiting processing step, the near-net medical device or a portion of a medical device (e.g., a frame of a medical device, etc.), a blank, a rod, a tube, etc. is annealed at a temperature of about 1000° C. to 1600° C. for about 2 minutes to 100 minutes. In another non-limiting processing step, the near-net medical device or a portion of a medical device (e.g., a frame of a medical device, etc.), a blank, a rod, a tube, etc. is annealed at a temperature of about 1100° C. to 1500° C. for about 5 minutes to 30 minutes. The annealing process typically occurs in an inert environment or an oxygen reducing environment in order to limit the amount of impurities that may be embedded in the refractory metal alloy or the metal alloy containing at least 15 awt.% rhenium during the annealing process. One non-limiting oxygen reducing environment that can be used during the annealing process is a hydrogen environment; however, it is understood that a vacuum environment can be used or one or more other or additional gases can be used to create the oxygen reducing environment. At the annealing temperature, the hydrogen-containing atmosphere can further reduce the amount of oxygen in the near-clean medical device or a portion of a medical device (e.g., a frame of a medical device, etc.), a billet, a rod, a tube, etc. The chamber in which the near-clean medical device or a portion of a medical device (e.g., a frame of a medical device, etc.), a billet, a rod, a tube, etc. is annealed should be substantially free (e.g., 0 ppm-50 ppm and all values ​​and ranges therebetween) of impurities (e.g., carbon, oxygen, nitrogen, etc.) in order to limit the amount of impurities that may be embedded in the near-clean medical device or a portion of a medical device (e.g., a frame of a medical device, etc.), a billet, a rod, a tube, etc. during the annealing process. The annealing chamber is typically formed of a material that does not impart impurities to the near-net medical device or portion of a medical device (e.g., a frame of a medical device, etc.), billet, rod, tube, etc., because the near-net medical device or portion of a medical device (e.g., a frame of a medical device, etc.), billet, rod, tube, etc. is being 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, ceramics, etc.When the near-net medical device or portion of a medical device (e.g., a frame of a medical device, etc.), billet, rod, tube, etc. is constrained in the annealing chamber, the restraining device for contacting the near-net medical device or portion of a medical device (e.g., a frame of a medical device, etc.), billet, rod, tube, etc. is typically formed of a material that does not introduce impurities into the refractory metal alloy or the metal alloy containing at least 15 awt.% rhenium during processing of the near-net medical device or portion of a medical device (e.g., a frame of a medical device, etc.), billet, rod, tube, etc. Non-limiting examples of materials that can be used to at least partially form the restraining device include, but are not limited to, molybdenum, titanium, yttrium, zirconium, rhenium, cobalt, chromium, tantalum, and / or tungsten. In one non-limiting embodiment, when the refractory metal alloy or the metal alloy containing at least 15 awt.% rhenium is exposed to temperatures above 150°C for any process step including annealing, the materials contacting the refractory metal alloy or the metal alloy containing at least 15 awt.% rhenium during processing of the refractory metal alloy or the metal alloy containing at least 15 awt.% rhenium are typically made of chromium, cobalt, molybdenum, rhenium, tantalum, and / or tungsten. When the refractory metal alloy or the metal alloy containing at least 15 awt.% rhenium is processed at lower temperatures (i.e., 150°C or less), materials made of Teflon may also or alternatively be used. TM The material the part is made of.

[0130] According to another and / or alternative non-limiting aspect of the present disclosure, the parameters of the annealing can be changed as the cross-sectional area or diameter of the near-net medical device or portion of a medical device (e.g., a frame of a medical device, etc.), billet, rod, tube, etc. and / or the wall thickness of the near-net medical device or portion of a medical device (e.g., a frame of a medical device, etc.), billet, rod, tube, etc. changes. It has been found that good grain size characteristics of the near-net medical device or portion of a medical device (e.g., a frame of a medical device, etc.), billet, rod, tube, etc. can be achieved when the annealing parameters are changed as the parameters of the near-net medical device or portion of a medical device (e.g., a frame of a medical device, etc.), billet, rod, tube, etc. change. For example, as the wall thickness decreases, the annealing temperature decreases accordingly; however, the annealing time can be increased. As can be appreciated, the annealing temperature of the near-net medical device or portion of a medical device (e.g., a frame of a medical device, etc.), billet, rod, tube, etc. can decrease as the wall thickness decreases, but the annealing time can remain the same or can also be reduced as the wall thickness decreases. After each annealing process, the grain size of the metal in the near-net medical device or portion of the medical device (e.g., a frame of a medical device, etc.), billet, rod, tube, etc. should be no greater than 4 ASTM. Typically, the grain size range is about 4 ASTM-20 ASTM (and all values ​​and ranges therebetween). It is believed that small grain sizes can be obtained when the annealing temperature is reduced as the wall thickness decreases. The grain size of the metal in the near-net medical device or portion of the medical device (e.g., a frame of a medical device, etc.), billet, rod, tube, etc. should be as uniform as possible. In addition, the σ phase of the metal in the near-net medical device or portion of the medical device (e.g., a frame of a medical device, etc.), billet, rod, tube, etc. should be reduced as much as possible. The σ phase is a spherical, elliptical, or tetragonal crystal shape in a refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium. After final drawing of the near-net medical device or portion of a medical device (e.g., a frame of a medical device, etc.), billet, rod, tube, etc., a final annealing of the near-net medical device or portion of a medical device (e.g., a frame of a medical device, etc.), billet, rod, tube, etc. may be performed for final strengthening of the near-net medical device or portion of a medical device (e.g., a frame of a medical device, etc.), billet, rod, tube, etc.; however, this is not required. When used, this final annealing process typically occurs at a temperature of about 500° C.-1600° C. (and all values ​​and ranges therebetween) for at least about 1 minute; however, other temperatures and / or time periods may be used.

[0131] According to another and / or alternative non-limiting aspect of the present disclosure, the use of a refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium to partially or completely form a medical device or a portion of a medical device (e.g., a 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 portion of a medical device (e.g., a frame of a medical device, etc.) 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 containing at least 15 awt.% rhenium can be used in a medical device or a portion of a medical device (e.g., a frame of a medical device, etc.) to achieve similar strength compared to a frame of a medical device formed from a different metal. Thus, through the use of a refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium, the resulting medical device can be made smaller and less bulky without sacrificing the strength and durability of the medical device. Such a medical device can have a smaller profile and can therefore be inserted into smaller areas, openings, and / or passages. Refractory metal alloys or metal alloys containing at least 15awt.% rhenium can also increase the radial strength of medical devices or parts of medical devices (e.g., frames of medical devices, etc.). For example, the thickness of the wall of a medical device or a part of a medical device (e.g., a 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 can be made thinner and achieve similar or improved radial strength compared to the thicker wall frame of a medical device formed of stainless steel, titanium alloys, or cobalt and chromium alloys. Refractory metal alloys or metal alloys containing at least 15awt.% rhenium can also provide stress-strain performance, bendability, and flexibility of medical devices or parts of medical devices (e.g., frames of medical devices, etc.), thereby extending the life of the medical device. For example, the medical device can be used in an area where the medical device is subjected to bending. Due to the improved physical properties of the medical device from the refractory metal alloy or the metal alloy containing at least 15awt.% rhenium, the medical device has improved resistance to compression fracturing in such frequent bending environments. Additionally or alternatively, the increased bendability and / or flexibility of a medical device or portion of a medical device (e.g., a frame of a medical device, etc.) due to the use of a refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium can enable the medical device to be more easily inserted into various areas of the body. For medical devices configured to be curled (e.g., stents, frames of heart valves, etc.), the refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium can also reduce the degree of springback during curling and / or expansion of the medical device or portion of a medical device (e.g., a frame of a medical device, etc.). For example, due to the use of a refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium, the medical device better maintains its curled form and / or better maintains its expanded form after expansion.Thus, when the medical device is to be mounted on a delivery device when the medical device is crimped, the medical device better maintains its smaller profile during insertion of the medical device into various areas of the body. Moreover, the medical device better maintains its expanded profile after expansion to promote the success of the medical device in the treatment area. In addition to the physical properties of the medical device improved by the use of the refractory metal alloy or the metal alloy containing at least 15 awt.% rhenium, the refractory metal alloy or the metal alloy containing at least 15 awt.% rhenium also has improved radiopaque properties compared to standard materials such as stainless steel or cobalt-chromium alloys, thereby reducing or eliminating the need to use marker materials on the medical device. For example, it is believed that the radiopaqueness of the refractory metal alloy or the metal alloy containing at least 15 awt.% rhenium is at least about 10%-20% higher than that of stainless steel or cobalt-chromium alloys.

[0132] According to another and / or alternative non-limiting aspect of the present disclosure, a refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium is subjected to a final heat treatment process along a portion or all of the longitudinal length of a refractory metal alloy block or a metal alloy containing at least 15 awt.% rhenium to be used to partially or completely form a medical device. The final heat treatment process is used to soften the refractory metal alloy or the metal alloy containing at least 15 awt.% rhenium (e.g., increase flexibility, increase bendability, reduce yield strength and / or ultimate tensile strength). As the distance into the heated section of the refractory metal alloy block or the metal alloy containing at least 15 awt.% rhenium increases, the force to rupture the refractory metal alloy block or the metal alloy containing at least 15 awt.% rhenium decreases. This is because the yield strength and / or ultimate tensile strength of the refractory metal alloy block or the metal alloy containing at least 15 awt.% rhenium decreases with increasing temperature during the final heat treatment of the refractory metal alloy block or the metal alloy containing at least 15 awt.% rhenium. During the final heat treatment, the crystal structure of the refractory metal alloy block or the metal alloy rod containing at least 15 awt.% rhenium is rearranged, and stresses may be relieved due to previous cold working and / or tempering of the refractory metal alloy block or the metal alloy containing at least 15 awt.% rhenium. Typically, there is no quenching of the refractory metal alloy or the metal alloy containing at least 15 awt.% rhenium after the final heat treatment process. Therefore, the heated refractory metal alloy or the metal alloy containing at least 15 awt.% rhenium can be cooled by simply exposing it to the ambient temperature of the atmosphere surrounding the heated refractory metal alloy or the metal alloy containing at least 15 awt.% rhenium (e.g., a non-oxidizing gas environment at a temperature of 10°C-100°C and all values ​​and ranges therebetween, an inert gas environment at a temperature of 10°C-100°C and all values ​​and ranges therebetween, an air environment at a temperature of 10°C-100°C and all values ​​and ranges therebetween, etc.). Typically, the cooling rate after the final heat treatment step is less than 100°C / s (e.g., less than 1°C / s-100°C / s and all values ​​and ranges therebetween), and typically less than 50°C / s, and more typically less than 25°C / s. The final heat treatment may be uniform or non-uniform along the longitudinal length of the bulk of the refractory metal alloy or the metal alloy containing at least 15 awt.% rhenium to be used to partially or completely form a medical device. The time of the final heat treatment at different locations along the longitudinal length of the bulk of the refractory metal alloy or the metal alloy containing at least 15 awt.% rhenium to be used to partially or completely form a medical device may be the same or different. The temperature of the final heat treatment at different locations along the longitudinal length of the bulk of the refractory metal alloy or the metal alloy containing at least 15 awt.% rhenium to be used to partially or completely form a medical device may be the same or different.In one non-limiting embodiment, the portion of the refractory metal alloy bulk or metal alloy containing at least 15 awt. % rhenium to be subjected to final heat treatment is a) exposed to a uniform temperature for a uniform period of time and b) cooled at substantially the same cooling rate and c) not subjected to quenching.

[0133] According to another and / or alternative non-limiting aspect of the present disclosure, a refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium is subjected to a final heat treatment process along a portion or all of the longitudinal length of a refractory metal alloy piece or a metal alloy containing at least 15 awt.% rhenium to be used to partially or completely form a medical device, and a heat shielding arrangement is used to prevent a portion of the metal alloy block from being subjected to the final heat treatment. The type of shielding member is non-limiting. In one non-limiting arrangement, the heat shielding is achieved by inserting only a portion of the refractory metal alloy block or a metal alloy containing at least 15 awt.% rhenium into the oven. In one non-limiting configuration, an opening is provided in the outer surface of a heating oven (e.g., a sand furnace, etc.) that enables the refractory metal alloy block or a portion of the metal alloy containing at least 15 awt.% rhenium to be inserted into the interior of the heating oven. The location of the opening is non-limiting. In another non-limiting arrangement, the opening is located in an oven cover or furnace cover. The refractory metal alloy block or the metal alloy containing at least 15 awt.% rhenium (e.g., MoRe alloy, etc.) can be in the form of a rod; however, this is not required. Such a rod can be used as a rod for spinal surgery; however, the rod can be used in other medical procedures. The rod can have a substantially 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 arrangement, the portion of the rod located in the heating oven is exposed to a temperature of up to 1000°C (e.g., 100°C-1000°C and all values ​​and ranges therebetween). In one specific non-limiting arrangement, the portion of the rod in the furnace is initially exposed to a temperature of 10°C-250°C (and all values ​​and ranges therebetween, 90°C-160°C) (e.g., a preheating step), and the heat is then increased to 500°C-1000°C (and all values ​​and ranges therebetween, 550°C-700°C) over 0.5 hour-10 hours (and all values ​​and ranges therebetween, 1 hour-3 hours), and the heat in the heating oven is thereafter maintained at the maximum temperature for 1 hour-15 hours (and all values ​​and ranges therebetween, 2 hours-10 hours). The heating of the rod in the heating oven causes the heated portion to have a reduced yield strength and / or 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 oven. During the final heating of the rod, a portion of the rod may be removed from the heating oven during the heating period, such that the lower portion of the rod is heated in the heating oven for a longer period of time than the middle portion of the rod. Such heating of the rod may cause the lower portion of the rod, which is heated longer, to have 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 top portions that are not inserted into the heated oven.Typically, there is no quenching of the refractory metal alloy or the metal alloy containing at least 15 awt.% rhenium after the final heat treatment process. Thus, the heated refractory metal alloy or the metal alloy containing at least 15 awt.% rhenium can be cooled by merely exposing to the ambient temperature of the atmosphere surrounding the heated refractory metal alloy or the metal alloy containing at least 15 awt.% rhenium (e.g., a non-oxidizing gas environment at a temperature of 10°C-100°C and all values ​​and ranges therebetween, an inert gas environment at a temperature of 10°C-100°C and all values ​​and ranges therebetween, an air environment at a temperature of 10°C-100°C and all values ​​and ranges therebetween, etc.). Typically, the cooling rate after the final heat treatment step is less than 100°C / s (e.g., less than 1°C / s-100°C / s and all values ​​and ranges therebetween), and typically less than 50°C / s, and more typically less than 25°C / s.

[0134] 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 long (e.g., 2 inches-40 inches and all values ​​and ranges therebetween; up to 20 inches, etc.); and thereafter cut to a desired length (e.g., 20 mm-500 mm [and all values ​​and ranges therebetween], with a diameter of 3 mm-8 mm [and all values ​​and ranges therebetween]). It should be understood that other rod lengths can be used. As can be understood, the cut portion of the rod can be a) a rod portion that has undergone a final heating process, b) a rod portion that has not undergone a final heating process, or c) a rod portion of which a portion has undergone a final heating process and a portion has not undergone a 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) may vary along the longitudinal length of the rod portion.

[0135] According to another and / or alternative non-limiting aspect of the present disclosure, a rod having different degrees of flexibility or bendability but having the same cross-sectional size and shape along the longitudinal length of the rod can be formed for a specific medical procedure. Therefore, a medical professional can use the same size spinal rod in a medical procedure (e.g., spinal surgery) during the procedure, but only selects a rod with a desired flexibility or bendability for a specific area of ​​the spine. Therefore, the need to use a grounding rod with different diameters during a medical procedure can be eliminated. Therefore, the support structure used with the spinal rod can be of uniform size, and a single size screw (e.g., pedicle screw) for fixing the rod to other spinal structures can be used, thereby simplifying the medical procedure and reducing errors during the medical procedure. The spinal rod can be color-coded (e.g., color coating, etc.) or have other or additional markings to indicate the flexibility or bendability of the rod. This color coding or marking can be used to allow medical professionals to easily identify which spinal rod should be selected for a specific position in a spinal surgery. Therefore, a plurality of spinal rods having the same cross-sectional size and shape along the longitudinal length of the rod but having 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 the medical procedure, and the color coding or markings enable the medical professional to quickly, easily and accurately identify the desired spinal rod for a specific position of spinal surgery. Historically, thinner diameter rods are used at the top portion of the spine in spinal surgery, and larger diameter rods are used at the lower portion of the spine in spinal surgery. The smaller diameter rod allows the spine to have greater flexibility or bendability at a position of the spine closer to the head where greater flexibility or bendability is desired after spinal surgery. However, a thicker diameter spinal rod is desired at the lower portion of the spine because less flexibility or bendability is desired at this position after spinal surgery. A medium thick diameter spinal rod is desired at a position between the top portion and the bottom portion of the spine because medium flexibility or bendability is desired at this position after spinal surgery. Therefore, during surgical procedures, rods of multiple diameters must be provided in order to use the appropriate rod with the desired flexibility or bendability. One problem with grinding rods to form rods of different diameters is that the screws (e.g., pedicle screws) used to correctly fix the rods need to be changed based on the diameter of the rod. The top portion of the screw includes a rod opening of a specific diameter and shape. This correct screw selection may make it difficult for the surgeon to determine which screw is the correct screw to use with a rod of a specific diameter. By being able to use rods of uniform diameter that can have variable flexibility or bendability according to the present disclosure, the surgeon's time can be saved, inventory can be reduced, the chance of surgical errors can be reduced, and better operation (more uniform spinal alignment) can be achieved for the patient.

[0136] According to another and / or alternative non-limiting aspect of the present disclosure, there is provided a rod or pile wherein different portions of the rod or pile along the longitudinal length of the rod or pile are heat treated in different amounts so that the rod or pile has a plurality of different physical properties along the longitudinal length of the rod or pile. In one non-limiting configuration, 10%-50% (and all values ​​and ranges therebetween) of the longitudinal length of the rod or pile has been heat treated by a different amount than 10%-50% (and all values ​​and ranges therebetween) of the other portions of the rod or pile, and wherein the rod or pile is formed of a uniform composition, and the rod or pile has a uniform cross-sectional shape and area along the longitudinal length of the rod or pile, and the physical properties of the rod or pile (e.g., flexibility or bendability, flexural stress at break, displacement at break, force at break, etc.) are different along different regions along the longitudinal length of the rod or pile.

[0137] According to another and / or alternative non-limiting aspect of the present disclosure, a collection of rods or posts for use in an orthopedic or spinal procedure is provided, wherein a plurality of rods or posts have different physical properties (e.g., flexural stress at break, displacement at break, force at break, etc.) along 60%-100% of the longitudinal length of the rod (and all values ​​and ranges therebetween), and each of the rods is color-coded and / or otherwise marked to indicate the relative physical properties of each of the rods so that a surgeon can visually identify a rod or post with specific physical properties for use in an orthopedic or spinal procedure. In this arrangement, a surgeon can select a rod or post with a desired bendability and / or flexibility for use in a specific medical procedure and at a specific location in a patient's body.

[0138] According to another and / or alternative non-limiting aspect of the present disclosure, a method is provided for manufacturing a plurality of medical devices having the same or similar size, shape, and configuration and formed from the same refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium, but the plurality of medical devices having different physical properties with respect to at least flexibility or bendability, yield strength, and / or ultimate tensile strength. In one non-limiting arrangement, a plurality of devices (e.g., medical devices [e.g., spinal rods, spinal screws (e.g., pedicle screws), spinal posts, etc.], medical tools, etc.) are provided that a) are formed of the same metal alloy (e.g., refractory metal alloys [e.g., MoRe alloys, Re alloys, Mo alloys, Ta alloys, W alloys, etc.], metal alloys containing at least 15 awt.% rhenium, etc.), b) are exactly the same size, shape, and configuration or have 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 devices), c) have different physical properties, at least in terms of flexibility or bendability, yield strength, and / or ultimate tensile strength, due at least in part to the metal alloys being subjected to different final heating processes on the plurality of devices, and d) optionally have one or more markings (e.g., a colored coating, etching on an outer surface, symbols on an outer surface, etc.) for visually indicating the performance or relative performance of the plurality of devices. In another non-limiting arrangement, multiple medical devices in the form of spinal rods, spinal screws, or spinal posts are provided that a) are formed from the same metal alloy (e.g., a refractory metal alloy, a metal alloy containing at least 15 awt.% rhenium, etc.), b) have similar size, shape, and configuration along 60%-100% (and all values ​​and ranges therebetween) of the longitudinal length of the medical devices, c) have different physical properties along one or more portions of the medical devices along the longitudinal length of the medical devices, at least in terms of flexibility or bendability, yield strength, and / or ultimate tensile strength, due at least in part to the metal alloys being subjected to different final heating processes on the multiple medical devices (e.g., the top portion of the medical device has different physical properties from the middle portion and / or bottom portion of the medical device, the bottom portion of the medical device has different physical properties from the middle portion of the medical device, etc.), and d) have one or more markings (e.g., a colored coating, etching on an outer surface, symbols on an outer surface, etc.) for visually indicating the performance or relative performance of the multiple medical devices.

[0139] According to another and / or alternative non-limiting aspect of the present disclosure, a method of using a medical device in the form of a spinal rod or spinal post in a spinal surgical procedure is provided, comprising: a) providing a plurality of spinal rods or spinal posts, the plurality of spinal rods or spinal posts i) being formed of 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 awt.% rhenium, etc.), ii) having a body member that is generally cylindrical in shape and has a constant cross-sectional shape and cross-sectional size or diameter 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 posts having different physical properties, at least in terms of flexibility or bendability, yield strength and / or ultimate tensile strength, at least in part due to the metal alloy being subjected to different final heating processes on the body members of the plurality of spinal rods or spinal posts, and iv) the spinal rods or spinal posts optionally having one or more for visually indicating the properties or relative properties of one or more or all of the spinal rods or spinal posts. a) identifying locations where a plurality of spinal rods or spinal posts are to be used in a spinal surgical procedure; c) determining a desired flexibility or bendability of each spinal rod or post to be used in a particular location of the spine during the spinal surgical procedure; d) selecting a spinal rod or post having the desired flexibility or bendability (and wherein such selection is optionally based on the markings on the spinal rod or spinal post; e) selecting a spinal screw (e.g., a pedicle screw) to be used in the spinal procedure, and wherein each of the spinal screws includes a top portion including a post opening configured to receive a portion of a spinal rod or spinal post such that the spinal rod or spinal post can be secured in the post opening, thereby securing the spinal rod or spinal post to the top portion of the spinal bone screw, and wherein the shape, size, and configuration of the post holes of a plurality of all of the spinal bone screws are identical; f) inserting two or more spinal screws into a patient's bone (e.g., spine, etc.); and g) securing the selected spinal rod or spinal post having the desired flexibility or bendability to the spinal bone screws during the spinal surgical procedure.

[0140] According to another and / or alternative non-limiting aspect of the present disclosure, a method of providing a spinal fusion component to a medical provider or healthcare system is provided, the method comprising: a) providing a plurality of spinal screws or pedicle screws, each of the spinal screws comprising a body portion configured to be inserted into a spinal column and a head portion connected to the body portion, and the head portion being configured to include a post opening and a fixation arrangement, wherein the longitudinal length of the body portion is 20 mm-80 mm (and all values ​​and ranges therebetween), wherein the post opening is designed to allow a portion of a spinal rod or post to be inserted therethrough, wherein the configuration of the post opening is the same as that of the spinal screw regardless of the longitudinal length of the body, and the fixation arrangement is designed to secure the spinal rod or spinal post in the post opening; b) providing a plurality of spinal rods or spinal posts, the plurality of spinal rods or spinal posts i) being formed of 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 awt.% rhenium, etc.), and ii) having a body member, the body The component shape is generally cylindrical and has a constant cross-sectional shape and cross-sectional size or diameter along 60%-100% of the longitudinal length of the main body component (and all values ​​and ranges therebetween), iii) the main body components of the plurality of spinal rods or spinal posts have different physical properties, at least in terms of flexibility or bendability, yield strength and / or ultimate tensile strength, at least in part due to the metal alloy being subjected to different final heating processes on the main body components of the plurality of spinal rods or spinal posts, and iv) the spinal rods or spinal posts optionally have one or more markings (e.g., a colored coating, etching on the outer surface, symbols on the outer surface, etc.) for visually indicating the properties or relative properties of one or more or all of the spinal rods or spinal posts; c) enabling a medical provider or health care system to use a plurality of the provided spinal screws for use in a specific medical procedure; d) enabling a medical provider or health care system to use one or more of the provided spinal rods or spinal posts for use in a specific medical procedure, and wherein the resulting spinal rods or spinal posts will properly fit and be secured to the openings of the spinal screws.

[0141] According to another and / or alternative non-limiting aspect of the present disclosure, the use of a refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium to form all or a portion of a medical device can result in several advantages over medical devices formed from other materials. These advantages include, but are not limited to:

[0142] Refractory metal alloys or metal alloys containing at least 15 awt.% rhenium have increased strength and / or hardness compared to stainless steel, chromium-cobalt alloys, or titanium alloys, so a smaller amount of refractory metal alloys or metal alloys containing at least 15 awt.% rhenium can be used in a medical device to achieve similar strength compared to a medical device formed from a different metal. Thus, through the use of refractory metal alloys or metal alloys containing at least 15 awt.% rhenium, the resulting medical device can be made smaller and less bulky without sacrificing the strength and durability of the medical device. The medical device can also have a smaller profile and can therefore be inserted into smaller areas, openings, and / or passages. Thinner refractory metal alloy or metal alloy containing at least 15 awt.% rhenium struts used to form a frame or other portion of a medical device can be used to form a frame or other portion of a medical device that has the strength that thicker struts or other structures of the medical device would require when formed from stainless steel, chromium-cobalt alloys, or titanium alloys.

[0143] The increased strength of the refractory metal alloy or the metal alloy containing at least 15 awt.% rhenium also results in increased radial strength of the medical device. For example, the thickness of the wall of the medical device can be made thinner and achieve similar or improved radial strength compared to a thicker walled medical device formed from stainless steel, cobalt and chromium alloys, or titanium alloys.

[0144] · The refractory metal alloy or metal alloy containing at least 15 awt.% rhenium has improved stress-strain properties, bendability, elongation and / or flexibility or bendability of the medical device compared to stainless steel and chromium-cobalt alloys, resulting in an extended life of the medical device. For example, the medical device can be used in areas where the medical device is subjected to repeated bending. Due to the improved physical properties of the medical device from the refractory metal alloy or metal alloy containing at least 15 awt.% rhenium, the medical device has improved resistance to compression fracturing in such frequent bending environments. These improved physical properties are at least partially attributed to the composition of the refractory metal alloy or metal alloy containing at least 15 awt.% rhenium, the grain size of the refractory metal alloy or metal alloy containing at least 15 awt.% rhenium, the carbon, oxygen and nitrogen content of the refractory metal alloy or metal alloy containing at least 15 awt.% rhenium, and / or the carbon / oxygen ratio of the refractory metal alloy or metal alloy containing at least 15 awt.% rhenium.

[0145] · A refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium having and wherein at least a portion of a medical device is configured to be crimped and / or expanded (e.g., a stent, a frame of a heart valve, etc.), a reduced degree of springback during crimping and / or expansion of the medical device compared to stainless steel, chromium-cobalt alloys, or titanium alloys. The medical device formed from the refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium better maintains its crimped form and / or better maintains its expandable form after expansion due to the use of the refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium. Thus, when the medical device is to be mounted on a delivery device when the medical device is crimped, the medical device better maintains its smaller profile during insertion of the medical device into a body passage. Moreover, the medical device better maintains its expanded profile after expansion to facilitate success of the medical device in the treatment area.

[0146] • The use of a refractory metal alloy or a metal alloy containing at least 15 awt. % rhenium in a medical device results in the medical device better conforming to an irregularly shaped body passage when expanded in the body passage compared to medical devices formed from stainless steel, chromium-cobalt alloys, or titanium alloys.

[0147] Refractory metal alloys or metal alloys containing at least 15 awt.% rhenium have improved radiopacity compared to standard materials such as stainless steel or cobalt-chromium alloys, thereby reducing or eliminating the need to use marker materials on medical devices. For example, the radiopacity of the refractory metal alloy or metal alloy containing at least 15 awt.% rhenium is at least about 10%-20% higher than that of stainless steel or cobalt-chromium alloys.

[0148] • The refractory metal alloy or the metal alloy containing at least 15 awt. % rhenium has improved fatigue ductility when subjected to cold working compared to cold working of stainless steel, chromium-cobalt alloys or titanium alloys.

[0149] • The refractory metal alloy or the metal alloy containing at least 15 awt. % rhenium has improved durability compared to stainless steel, chromium-cobalt alloy or titanium alloy.

[0150] - The refractory metal alloy or the metal alloy containing at least 15 awt. % rhenium has an increased hydrophilicity compared to stainless steel, chromium-cobalt alloy or titanium alloy.

[0151] • The refractory metal alloy or the metal alloy containing at least 15 awt. % rhenium has reduced ion release in body passages compared to stainless steel, chromium-cobalt alloys or titanium alloys.

[0152] Refractory metal alloys or metal alloys containing at least 15 awt.% rhenium are less irritating to the body than stainless steel, cobalt-chromium alloys, or titanium alloys, and thus can result in less inflammation, faster healing, and increased success of medical devices. When a medical device is expanded in a body passage, some minor damage may occur to the interior of the passage. As the body begins to heal such minor damage, the body has fewer adverse reactions to the presence of the refractory metal alloy or metal alloy containing at least 15 awt.% rhenium than other metals such as stainless steel, cobalt-chromium alloys, or titanium alloys.

[0153] Refractory metal alloys or metal alloys containing at least 15 awt.% rhenium have lower magnetic susceptibility than CoCr alloys, TiAlV alloys and / or stainless steels, resulting in lower rates of potential defects in the medical device or patient complications following implantation of the medical device when the patient is subjected to MRI or other medical devices that generate strong magnetic fields.

[0154] One non-limiting object of the present disclosure is to provide a refractory metal alloy or a metal alloy containing at least 15 awt. % rhenium according to the present disclosure that can be used to partially or fully form a medical device.

[0155] It is another and / or alternative non-limiting object of the present disclosure to provide a medical device formed partially or completely from the refractory metal alloy or metal alloy containing at least 15 awt. % rhenium of the present disclosure and having an improved surgical success rate.

[0156] Another and / or alternative non-limiting object 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 awt.% rhenium according to the present disclosure that inhibits or prevents the formation of microcracks during processing of the refractory metal alloy or the metal alloy containing at least 15 awt.% rhenium.

[0157] It is another and / or alternative non-limiting object of the present disclosure to provide a medical device formed partially or completely from a refractory metal alloy or a metal alloy containing at least 15 awt. % rhenium according to the present disclosure, and wherein the medical device has enhanced physical properties.

[0158] It is another and / or alternative non-limiting object of the present disclosure to provide a medical device composed at least in part of a refractory metal alloy or a metal alloy containing at least 15 awt. % rhenium according to the present disclosure having increased strength and / or hardness.

[0159] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device that at least partially comprises a refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium according to the present disclosure, and the refractory metal alloy or the metal alloy containing at least 15 awt.% rhenium enables the medical device to be formed with less material than previous medical devices without sacrificing the strength of the medical device.

[0160] Another and / or alternative non-limiting object 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 awt.% rhenium according to the present disclosure to inhibit or prevent the formation of microcracks during processing of the refractory metal alloy or the metal alloy containing at least 15 awt.% rhenium into a medical device.

[0161] Another and / or alternative non-limiting object 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 awt.% rhenium according to the present disclosure that inhibits or prevents crack propagation and / or fatigue failure of the refractory metal alloy or the metal alloy containing at least 15 awt.% rhenium.

[0162] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device comprising a refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium, the refractory metal alloy or the metal alloy containing at least 15 awt.% rhenium having a nitriding process to form a nitride layer on an outer surface of the refractory metal alloy or the metal alloy containing at least 15 awt.% rhenium.

[0163] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device comprising a refractory metal alloy or a metal alloy containing at least 15 awt. % rhenium, wherein the medical device comprising the refractory metal alloy or the metal alloy containing at least 15 awt. % rhenium has been subjected to a die forging process.

[0164] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device comprising a refractory metal alloy or a metal alloy containing at least 15 awt. % rhenium, wherein the refractory metal alloy or the metal alloy containing at least 15 awt. % rhenium has been subjected to a cold working process.

[0165] Another and / or alternative non-limiting object of the present disclosure is a medical device comprising a refractory metal alloy or a metal alloy containing at least 15 awt. % rhenium having increased strength and / or hardness compared to stainless steel, chromium-cobalt alloys, or titanium alloys.

[0166] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device comprising a refractory metal alloy or a metal alloy containing at least 15 awt. % rhenium, thereby requiring a smaller amount of the refractory metal alloy or the metal alloy containing at least 15 awt. % rhenium to achieve similar strength compared to a medical device formed from a different metal.

[0167] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device comprising a refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium, and wherein at least a portion of the medical device is configured to be curled and / or expanded (e.g., a stent, a frame for a heart valve, etc.), the medical device having a smaller curl profile than a medical device formed from a different metal.

[0168] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device comprising a refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium, and wherein at least a portion of the medical device is configured to be curled and / or expanded (e.g., a stent, a frame for a heart valve, etc.), and wherein the medical device has thinner walls and / or struts than in a frame of the same shape formed from stainless steel, a cobalt and chromium alloy, or a titanium alloy, and wherein such a frame formed from a refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium has the same or increased radial strength when the frame is expanded from a curled configuration to an expanded configuration compared to such a frame formed from stainless steel or a cobalt and chromium alloy or a titanium alloy.

[0169] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device comprising a refractory metal alloy or a metal alloy comprising at least 15 awt.% rhenium, wherein the medical device has improved stress-strain properties, bendability properties, elongation properties, and / or flexibility or bendability properties compared to medical devices formed from stainless steel, titanium alloys, or chromium-cobalt alloys.

[0170] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device comprising a refractory metal alloy or a metal alloy containing at least 15 awt. % rhenium, wherein the medical device has an increased lifespan compared to medical devices formed from stainless steel, titanium alloys, or chromium-cobalt alloys.

[0171] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device comprising a refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium, and wherein at least a portion of the medical device is configured to be crimped and / or expanded (e.g., a stent, a frame for a heart valve, etc.), and the medical device has a reduced degree of recoil during crimping and / or expansion of the medical device compared to a frame of similar size, shape, and configuration formed from stainless steel, chromium-cobalt alloy, or titanium alloy.

[0172] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device comprising a refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium, wherein the medical device better conforms to an irregularly shaped body passage when expanded in the body passage as compared to a frame of similar size, shape, and configuration formed from stainless steel, chromium-cobalt alloy, or titanium alloy.

[0173] It is another and / or alternative non-limiting object of the present disclosure to provide a medical device comprising a refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium, wherein 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, chromium-cobalt alloy, or titanium alloy.

[0174] It is another and / or alternative non-limiting object of the present disclosure to provide a medical device comprising a refractory metal alloy or a metal alloy comprising at least 15 awt. % rhenium, wherein the medical device has improved durability compared to stainless steel, chromium-cobalt alloys, or titanium alloys.

[0175] It is another and / or alternative non-limiting object of the present disclosure to provide a medical device comprising a refractory metal alloy or a metal alloy comprising at least 15 awt. % rhenium, wherein the medical device has improved hydrophilicity compared to stainless steel, chromium-cobalt alloys, or titanium alloys.

[0176] It is another and / or alternative non-limiting object of the present disclosure to provide a medical device comprising a refractory metal alloy or a metal alloy containing at least 15 awt. % rhenium, wherein the medical device has reduced ion release in a body passageway compared to stainless steel, chromium-cobalt alloys, or titanium alloys.

[0177] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device comprising a refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium, wherein the medical device is less irritating to the body than stainless steel, cobalt-chromium alloys, or titanium alloys, thereby resulting in reduced inflammation, faster healing, and increased success rate of the medical device.

[0178] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device comprising a refractory metal alloy or a metal alloy comprising at least 15 awt. % rhenium, wherein the medical device is subjected to a final heat treatment process along a portion or all of the longitudinal length of the metal alloy.

[0179] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device comprising a refractory metal alloy or a metal alloy comprising at least 15 awt.% rhenium, wherein the medical device is subjected to a final heat treatment process along a portion or all of the longitudinal length of the metal alloy to soften the metal alloy (e.g., increase flexibility, increase bendability, reduce yield strength and / or ultimate tensile strength).

[0180] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device comprising a refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium, wherein the medical device is subjected to a final heat treatment process along a portion or all of the longitudinal length of the metal alloy to soften the metal alloy, and the metal alloy is not subjected to quenching after the final heat treatment process.

[0181] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device comprising a refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium, wherein the medical device is subjected to a final heat treatment process and thereafter cooled by exposure only to the ambient temperature of the atmosphere surrounding the heated metal alloy (e.g., 55°F-95°F and all values ​​and ranges therebetween, 70°F-80°F, etc.), and the cooling can optionally occur in a non-oxidizing gas environment, an inert gas environment, a partial or full vacuum [e.g., 0 atm.-0.5 atm.], etc.).

[0182] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device comprising a refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium, wherein the medical device is subjected to a final heat treatment process along a portion of the longitudinal length of the metal alloy, and a heat shield arrangement is used to prevent another portion of the metal alloy block from being subjected to the final heat treatment.

[0183] Another and / or alternative non-limiting object of the present disclosure is to provide a pole or stake having varying degrees of flexibility or bendability along the longitudinal length of the pole or stake but having the same cross-sectional size and shape.

[0184] Another and / or alternative non-limiting object of the present disclosure is to provide a rod or stake having varying degrees of flexibility or bendability along the longitudinal length of the rod or stake but having the same cross-sectional size and shape, and the rod or stake may be color coded (e.g., colored coating, etc.) or have other or additional markings to indicate the flexibility or bendability of the rod or stake.

[0185] Another and / or alternative non-limiting object 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 posts, etc.], medical tools, etc.) that a) are formed of the same metal alloy (e.g., refractory metal alloys [e.g., MoRe alloys, Re alloys, Mo alloys, Ta alloys, W alloys, etc.], metal alloys containing at least 15 awt.% rhenium, etc.), b) are exactly the same size, shape, and configuration or have 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 devices), c) have different physical properties, at least in terms of flexibility or bendability, yield strength, and / or ultimate tensile strength, due at least in part to the metal alloys being subjected to different final heating processes on the plurality of devices, and d) optionally have one or more indicia (e.g., a colored coating, etching on an outer surface, symbols on an outer surface, etc.) for visually indicating the performance or relative performance of the plurality of devices.

[0186] It is another and / or alternative non-limiting object of the present disclosure to provide a method of using a medical device in the form of a spinal rod or spinal post in a spinal surgical procedure, comprising: a) providing a plurality of spinal rods or spinal posts, the plurality of spinal rods or spinal posts i) being formed of 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 awt.% rhenium, etc.), ii) having a body member that is generally cylindrical in shape and has a constant cross-sectional shape and cross-sectional size or diameter 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 posts having different physical properties, at least in terms of flexibility or bendability, yield strength and / or ultimate tensile strength, at least in part due to the metal alloy being subjected to different final heating processes on the body members of the plurality of spinal rods or spinal posts, and iv) the spinal rods or spinal posts optionally having one or more indicators for visually indicating the properties or relative properties of one or more or all of the spinal rods or spinal posts. a) identifying a plurality of spinal rods or spinal posts to be used in a spinal surgical procedure; b) identifying locations where a plurality of spinal rods or spinal posts are to be used in a spinal surgical procedure; c) determining a desired flexibility or bendability of each spinal rod or post to be used in a particular location in the spine during the spinal surgical procedure; d) selecting a spinal rod or post having the desired flexibility or bendability (and wherein such selection is optionally based on the markings on the spinal rod or spinal post; e) selecting a spinal screw (e.g., a pedicle screw) to be used in the spinal procedure, and wherein each of the spinal screws includes a top portion including a post opening configured to receive a portion of a spinal rod or spinal post such that the spinal rod or spinal post can be secured in the post opening, thereby securing the spinal rod or spinal post to the top portion of the spinal bone screw, and wherein the shape, size, and configuration of the post holes of a plurality of all of the spinal bone screws are identical; f) inserting two or more spinal screws into a patient's bone (e.g., spine, etc.); and g) securing the selected spinal rod or spinal post having the desired flexibility or bendability to the spinal bone screws during the spinal surgical procedure.

[0187] Another and / or alternative non-limiting object of the present disclosure is to provide a method of providing a spinal fusion component to a medical provider or healthcare system, the method comprising: a) providing a plurality of spinal screws or pedicle screws, each of the spinal screws comprising a body portion configured to be inserted into a spinal column and a head portion connected to the body portion, and the head portion being configured to include a post opening and a fixation arrangement, wherein the longitudinal length of the body portion is 20 mm-80 mm (and all values ​​and ranges therebetween), wherein the post opening is designed to allow a portion of a spinal rod or post to be inserted therethrough, wherein the configuration of the post opening is the same as that of the spinal screw regardless of the longitudinal length of the body, and the fixation arrangement is designed to secure the spinal rod or spinal post in the post opening; b) providing a plurality of spinal rods or spinal posts, the plurality of spinal rods or spinal posts i) being formed of 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 awt.% rhenium, etc.), ii) having a body member, the body member The invention relates to a spinal rod or spinal post having a generally cylindrical shape and a constant cross-sectional shape and cross-sectional size or diameter along 60%-100% (and all values ​​and ranges therebetween) of the longitudinal length of the main body member, iii) the main body members of the plurality of spinal rods or spinal posts have different physical properties, at least in terms of flexibility or bendability, yield strength and / or ultimate tensile strength, at least in part due to the metal alloy being subjected to different final heating processes on the main body members of the plurality of spinal rods or spinal posts, and iv) the spinal rods or spinal posts optionally have one or more markings (e.g., a colored coating, etching on an outer surface, symbols on an outer surface, etc.) for visually indicating the properties or relative properties of one or more or all of the spinal rods or spinal posts; c) enabling a medical provider or health care system to use a plurality of the provided spinal screws for use in a specific medical procedure; d) enabling a medical provider or health care system to use one or more of the provided spinal rods or spinal posts for use in a specific medical procedure, and wherein the resulting spinal rod or spinal post will properly fit and be secured to the opening of the spinal screw.

[0188] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device formed at least in part from a refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium that overcomes several unmet needs present in comparable medical devices formed from CoCr alloys, TiAlV alloys, and stainless steels, namely one or more of the following: 1) the first insertion of a crimped medical device into an atrial or other blood vessel without the need to form a large hole in the aortic or other blood vessel, thereby reducing the incidence of fatal bleeding during treatment; 2) by creating a medical device (e.g., a stent, a medical device having a reduced crimp profile that is smaller than that of a medical device formed from CoCr alloys, TiAlV alloys, and stainless steels; 3) when the medical device is expanded in the treatment area, the incidence of paravalvular leakage and / or other types of leakage around the implanted medical device is reduced by using a frame formed of a refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium, which better conforms to the shape of the abnormally shaped heart valve orifice when the medical device is expanded, compared with the prior art medical devices formed of CoCr alloy, TiAlV alloy and stainless steel, thereby reducing the risk of stroke. The invention can be used to: reduce the incidence of and / or by increasing the success rate of implanted medical devices; 4) improve the radial strength of the expanded struts, posts and / or strut joints in the expandable frame and the strength of the expandable frame itself after the medical device is expanded; 5) reduce the amount of recoil of the expandable frame during curling and / or expansion of the expandable frame of the medical device; 6) enable the medical device to be used in a heart with a permanent pacemaker; 7) reduce the incidence of minor strokes during insertion and operation of the medical device at the treatment area; 8) reduce the incidence of coronary artery ostium damage; 9) improve anterior retraction; 10) reduce further aortic valve calcification and / or intravascular calcification after implantation of the medical device; 11) reduce the risk of further aortic valve calcification and / or intravascular calcification during the conduction of the medical device tube or other type of delivery system; 12) reduce the need for multiple crimping cycles when inserting the medical device onto a tube or other type of delivery system; 13) reduce the incidence of frame / stent fracture during crimping and / or expansion of the medical device; 14) reduce the incidence of biofilm-endocarditis after implantation of the medical device; 15) increase the hydrophilicity of the medical device to enhance tissue growth on and / or around the implanted medical device, 16) reduce the magnetic susceptibility of the medical device, 17) reduce the toxicity of the medical device, 18) reduce the amount of metal ion release from the medical device, and / or 19) increase the life of the leaflets and / or stents / frames and / or other components of the medical device after insertion of the medical device.

[0189] These and other advantages will become apparent to those skilled in the art upon reading and following this specification. BRIEF DESCRIPTION OF THE DRAWINGS

[0190] Reference may now be made to the accompanying drawings which illustrate various non-limiting embodiments that the present disclosure may take in physical form and in certain parts and arrangements of parts, in which:

[0191] Figure 1 A non-limiting process is illustrated for final heating of a medical device.

[0192] Figure 2 is a graph illustrating the amount of springback for several different metal alloys.

[0193] Figure 3 is a graphical illustration comparing the conformability of a metal strip or wire formed of a refractory metal alloy or a metal alloy containing at least 15 awt. % rhenium to the shape of a mold surface as compared to the conformability of a metal strip or wire of a CoCr alloy to the same mold surface.

[0194] FIG. 4A to FIG. 4C Graphs of stress versus percent area reduction are illustrated for TiAIV alloys, CoCr alloys, and MoRe alloys.

[0195] Figure 5 is a graph illustrating the difference in rigidity and yield strength of MoRe alloy, CoCr alloy, and TiAlV alloy.

[0196] Figures 6 to 8 is a graph illustrating the strength and fatigue ductility of TiAlV alloys, CoCr alloys, and MoRe alloys.

[0197] Fig. 9 The hydrophilicity of MoRe alloy, CoCr alloy and TiAlV alloy is exemplified.

[0198] Figure 10 to Figure 11 The ion release rate of a refractory metal alloy or a metal alloy containing at least 15 awt. % rhenium, such as MoRe, is exemplified.

[0199] Fig.12 The ion release rates from MoRe alloy, CoCr alloy and TiAlV alloy in the microstructure are exemplified.

[0200] Fig.13 is a table illustrating different final heat treatments of the spinal rod and the force required to bend each of the spinal rods.

[0201] Although specific terms are used in the following description for the sake of clarity, these terms are intended only to refer to the specific structures of the embodiments selected for illustration in the accompanying drawings, and are not intended to define or limit the scope of the present disclosure. In the accompanying drawings and the following description below, it should be understood that the same reference numerals refer to components with the same functions.

[0202] The singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.

[0203] As used in the specification and claims, the term "comprising" may include the embodiments of "consisting of" and "consisting essentially of." As used herein, the terms "comprise(s)," "include(s)," "having," "has," "can," "contain(s)," and variations thereof are intended to be open-ended transitional phrases, terms, or words that require the presence of specified ingredients / steps and permit the presence of other ingredients / steps. However, such descriptions should be interpreted as also describing a composition or process as "consisting of" and "consisting essentially of the listed ingredients / steps," which permits the presence of only the specified ingredients / steps, as well as any unavoidable impurities that may result therefrom, and excludes other ingredients / steps.

[0204] Numerical values ​​in the specification and claims of this application 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 stated value by less than experimental error attributable to routine measurement techniques of the type described in this application for determining the value.

[0205] All ranges disclosed herein are inclusive of the listed endpoints and are independently combinable (eg, the range of "2 grams to 10 grams" includes the endpoints 2 grams and 10 grams and all intermediate values).

[0206] The terms "about" and "approximately" can be used to encompass any numerical value that can vary without changing the basic function of the 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 a range of "2 to 4". In general, the terms "about" and "approximately" can refer to plus or minus 10% of the indicated number.

[0207] Unless expressly stated otherwise, percentages of elements are assumed to be percentages by weight of said element.

[0208] Medical devices according to the present disclosure may be any medical device that can be inserted or otherwise applied to a patient. 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, occlusive devices for blood vessels and other body passages, flow regulation and / or diversion devices for blood vessels, devices for aneurysm wall de-endothelialization, frames and other structures used with spinal implants, vascular implants, grafts, dental implants, wires used in medical procedures, bone implants; artificial intervertebral discs, artificial spinal discs, prosthetic implants or devices for repairing, replacing and / or supporting bone and / or cartilage, bone plates, nails; rods, screws, posts; cages, plates, pedicle screws, joint systems, anchors, bone spacers or intervertebral discs used in the body to support structures, mount structures and / or repair structures in the body (such as but not limited to human bodies, animal bodies, etc.).

[0209] As discussed above, Figure 1 Exemplary non-limiting processes for subjecting a portion or all of a medical device to a final heating process in order to reduce the yield strength and / or ultimate tensile strength of the portion of the refractory metal alloy or metal alloy containing at least 15 awt.% rhenium that has been subjected to the final heating process. Figure 1 As illustrated, the rod or stake subjected to final heating is shown as 20 inches; however, it should be understood that other rod or stake lengths may be used. Figure 1 As illustrated, the bottom portion of the rod or stake located in the heating oven is about 14 inches, and the top portion of the rod or stake located outside the heating oven is about 6 inches; however, it is understood that more rods or stakes or fewer rods or stakes can be positioned in the heating oven for the final heating process. In one non-limiting arrangement, the portion of the rod located in the heating oven is exposed to a temperature of up to 1000° C. (e.g., 100° C.-1000° C. and all values ​​and ranges therebetween). In one specific non-limiting arrangement, the rod portion located in the furnace is initially exposed to a temperature of 10°C-250°C (and all values ​​and ranges therebetween, 90°C-160°C) (e.g., a preheating step), and the heat is then increased to 500°C-1000°C (and all values ​​and ranges therebetween, 550°C-700°C) over 0.5 hour-10 hours (and all values ​​and ranges therebetween, 1 hour-3 hours), and the heat in the heating oven is thereafter maintained at the maximum temperature for 1 hour-15 hours (and all values ​​and ranges therebetween, 2 hours-10 hours).

[0210] Once the final heating of the rod or pile is complete, the rod or pile can be removed from the heating oven and allowed to cool slowly. Typically, the cooling rate after the final heat treatment step is less than 100°C / s (e.g., less than 1°C / s-100°C / s and all values ​​and ranges therebetween), and typically less than 50°C / s, and more typically less than 25°C / s.

[0211] Once the rod or pile has cooled, the rod or pile can then be cut into desired lengths (e.g., 20 mm-500 mm [and all values ​​and ranges therebetween], 3 mm-8 mm [and all values ​​and ranges therebetween] in diameter). As can be appreciated, the cut portion of the rod or pile can be a) a rod or pile portion that has been subjected to a final heating process, b) a rod or pile portion that has not been subjected to a final heating process, or c) a rod or pile portion in which a portion has been subjected to a final heating process and a portion has not been subjected to a final heating process. The physical properties of the rod or pile portion can be a) uniform or substantially uniform along the longitudinal length of the rod or pile portion, or b) vary along the longitudinal length of the rod or pile portion.

[0212] like Fig.13 As illustrated, a refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium, such as a MoRe alloy (e.g., 40 wt.%-60 wt.% Re and 40 wt.%-60 wt.% Mo) was subjected to different final heating processes, wherein test bar 1 was not subjected to the final heating process, and test bar 14 was subjected to the final heating process for the longest period of time. Test bars 2-13 were subjected to the final heating process for progressively longer periods of time. As illustrated in Table 1, the longer the rod or pile was subjected to the final heating process (the highest temperature in each of the final heating processes was the same [e.g., 550°C-650°C, 600°C, etc.], the smaller the force required to obtain a bending displacement of about 21.5%. Thus, Table 1 illustrates that rods or piles having the same cross-sectional shape and the same cross-sectional area and formed from the same refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium can have different yield strengths and ultimate tensile strengths after subjecting the rod or pile to different final heating processes. Fig.13 None of the rods or piles represented in are quenched after the final heating process. The rods or piles are cooled by exposing them to ambient temperature (e.g., 65°F-85°F) while placed in a non-oxidizing environment.

[0213] A non-limiting method for using a plurality of rods or posts in a medical procedure, the plurality of rods or posts having the same or similar size, shape, and configuration and formed from the same refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium, but having different physical properties at least in terms of flexibility or bendability, yield strength, and / or ultimate tensile strength, the method comprising: a) providing a plurality of spinal rods or spinal posts, the plurality of spinal rods or spinal posts being 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 awt.% rhenium, etc.), awt.% rhenium, etc.), ii) having a main body member that is generally cylindrical in shape and has a constant cross-sectional shape and cross-sectional size or diameter along 60%-100% (and all values ​​and ranges therebetween) of the longitudinal length of the main body member, iii) the main body members of the plurality of spinal rods or spinal posts have different physical properties at least in terms of flexibility or bendability, yield strength and / or ultimate tensile strength due at least in part to the metal alloy being subjected to different final heating processes on the main body members of the plurality of spinal rods or spinal posts, and iv) the spinal rods or spinal posts optionally have a plurality of spinal rods or spinal posts for viewing. The present invention relates to the following aspects: a) one or more markings (e.g., a colored coating, an etching on an outer surface, symbols on an outer surface, etc.) that visually indicate the properties or relative properties of one or more or all of the spinal rods or spinal posts; b) identifying locations where multiple spinal rods or spinal posts are to be used in a spinal surgical procedure; c) determining the desired flexibility or bendability of each spinal rod or post to be used in a specific location in the spine during a spinal surgical procedure; d) selecting a spinal rod or post having the desired flexibility or bendability (and wherein such selection is optionally based on markings on the spinal rod or spinal post; e) selecting a spinal screw (e.g., a pedicle screw) to be used in a spinal procedure. nail), and wherein each of the spinal screws includes a top portion including a post opening configured to receive a portion of a spinal rod or a spinal post so that the spinal rod or spinal post can be secured in the post opening, thereby securing the spinal rod or spinal post to the top portion of the spinal bone screw, and wherein the shape, size and configuration of the post holes of a plurality of all of the spinal bone screws are the same; f) inserting two or more spinal screws into a patient's bone (e.g., spine, etc.); and g) securing a selected spinal rod or spinal post having a desired flexibility or bendability to the spinal bone screws during a spinal surgical procedure.

[0214] Reference now Figure 2When a medical device includes a frame that can be expanded or crimped (e.g., a stent, a frame of a heart valve, etc.), and the frame is partially or completely formed of a refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium, the amount of springback of the frame after the frame is crimped or expanded can be less than the springback of a frame of the same size, shape, and configuration formed of a different metal (such as a CoCr alloy or a Ti alloy). Figure 2 As illustrated, a curled or expanded frame formed from a CoCr alloy (e.g., 35Co-35Ni-20Cr-10Mo) will rebound by 9% or more (e.g., 9%-15% and all values ​​and ranges therebetween) after the radial curling force is removed from the frame. A frame formed from a Ti alloy (e.g., Ti-6Al-4V) will rebound by 6% or more (e.g., 6%-10% and all values ​​and ranges therebetween) after the radial curling or expansion force is removed from the frame. A frame formed from a refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium (e.g., MoRe alloy, etc.) has a springback of less than 2% when curled or expanded compared to a frame of similar shape, size, and configuration formed from a CoCr alloy or a Ti alloy. Despite the Figure 2 Not illustrated in the illustration, a frame formed from stainless steel (eg, 316, 316L) will also rebound by 7% or more (eg, 6%-15% and all values ​​and ranges therebetween) after the radial curling or expansion forces are removed from the frame.

[0215] Due to the springback of the frame formed by CoCr alloy, stainless steel or TiAlV alloy, the number of crimping cycles required to crimp the frame formed by refractory metal alloy or metal alloy containing at least 15awt.% rhenium is significantly less than the number of crimping cycles required to crimp the frame formed by stainless steel, CoCr or TiAlV. Typically, the frame formed by refractory metal alloy or metal alloy containing at least 15awt.% rhenium only requires one crimping cycle to obtain the desired crimping profile of the frame. Typically, the frame formed by stainless steel, CoCr or Ti alloy requires at least two and usually three of more crimping cycles to obtain the desired crimping profile of the frame. Due to this springback of the frame formed by stainless steel, CoCr alloy or Ti alloy, the frame must be repeatedly subjected to the crimping force in an attempt to obtain the minimum crimping outer diameter of the crimped frame. The need to subject the frame to multiple crimping cycles or procedures may potentially result in damage to the frame and / or damage to other components of the medical device (e.g., leaflets, skirts, damage to the balloon on the catheter, damage to one or more components on the catheter). Likewise, a frame formed of a refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium (e.g., a MoRe alloy) also has less rebound after expansion than a frame formed of stainless steel, CoCr, or a Ti alloy. Thus, a frame formed of a refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium will better conform to the shape of the channel in which the frame is expanded. In addition, a frame formed of a refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium will expand to its desired expanded state from a single inflation of the balloon of a balloon delivery catheter. Due to the significant rebound of frames formed of CoCr alloys, stainless steel (e.g., 316, 316L), and Ti alloys after expansion, the balloon of a balloon delivery catheter typically needs to be inflated multiple times to conform the frame to the shape of the heart channel in which the frame is expanded. Such multiple inflations of the balloon may result in an increased incidence of damage to components of the body channel or medical device (e.g., leaflets, skirts, etc.).

[0216] Figure 3An example of increased conformability to the bend of a wire, rod, or post formed from a refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium (such as MoRe) as compared to a wire, rod, or post of the same shape, size, and configuration formed from a CoCr alloy. As the framework of the medical device expands, the struts and posts of the framework plastically deform (e.g., typically deform outwardly) due to the expansion of an inflatable balloon or from some other expansion device. Typically, the treatment location in which the medical device is expanded is not perfectly cylindrical, nor does it have a perfectly shaped circular cross-sectional shape. Typically, the treatment area is damaged and / or includes plaque, calcium deposits, and / or other materials that cause the shape of the treatment area to be non-cylindrical or have a circular cross-sectional shape (e.g., a previously implanted medical device, etc.). Therefore, a frame that is able to better conform to the irregular shape in the treatment location results in a medical device that better fits the treatment area. It has been found that frames, wires, rods, struts, posts, etc. formed partially or completely from refractory metal alloys or metal alloys containing at least 15 awt.% rhenium (e.g., MoRe alloys, etc.) better conform to the curvature and / or shape of the channel into which the medical device is expanded compared to frames, wires, rods, struts, posts, 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). Figure 3 For example, when MoRe alloy wire and CoCr alloy wire of the same size, shape and configuration are subjected to the same bending force, MoRe alloy wire conforms to the ideal bending shape IBS better than CoCr alloy wire, that is, MoRe alloy wire has 23% to 31% better conformity to the ideal bending shape than wire formed from CoCr alloy. It has been found that wires of refractory metal alloys or metal alloys containing at least 15 awt.% rhenium (e.g., MoRe alloys, ReW alloys, MoReCr alloys, MoReTa alloys, MoReTi alloys, WCu alloys, ReCr alloys, Mo alloys, Re alloys, W alloys, Ta alloys, Nb alloys) have about 15% to 45% (and all values ​​and ranges therebetween) better conformity to the ideal bending shape than wires of the same size, shape and configuration formed from stainless steel, CoCr alloys and TiAlV alloys.

[0217] Reference now FIG. 4A to FIG. 4C, there are three graphs illustrating the percentage reduction in stress versus area for wires formed of TiAlV alloys, CoCr alloys, and MoRe alloys, and wherein each of the wires has the same size, shape, and configuration. The three graphs illustrate that medical devices formed of frames, rods, posts, struts, etc., partially or completely made of refractory metal alloys or metal alloys containing at least 15 awt.% rhenium (such as MoRe) will have improved properties such as strength, yield strength, ultimate tensile strength, fatigue ductility, greater deformation amplitude, material integrity between plastic deformation and failure, and durability compared to medical devices of the same shape, size, and configuration formed of frames, rods, posts, struts, etc., partially or completely made of materials such as CoCr alloys and TiAlV alloys. Medical devices formed of frames, rods, posts, struts, etc. made partially or completely of refractory metal alloys or metal alloys containing at least 15 awt.% rhenium (such as MoRe) can have a strength that is 1.5-5 times or more (and all values ​​and ranges therebetween) greater than that of medical devices formed of frames, rods, posts, struts, etc. made partially or completely of CoCr alloys and TiAlV alloys and stainless steel (e.g., 316, 316L).

[0218] Reference now Figure 5 Medical devices formed partially or completely of refractory metal alloys or metal alloys containing at least 15 awt.% rhenium (such as MoRe alloys) generally have greater hardness and yield strength than medical devices formed partially or completely of CoCr alloys and TiAlV alloys or stainless steel (e.g., 316, 316L) The frames, rods, posts, struts, etc. are compared to medical devices formed partially or completely of CoCr alloys and TiAlV alloys or stainless steel (e.g., 316, 316L). Figure 5 The top curve is a MoRe alloy containing 47.5 wt. % Re and the remainder Mo. Figure 5 The middle curve is a CoCr alloy containing 28 wt % Cr, 6 wt % Mo and the remainder Co. Figure 5 The bottom curve is a TiAlV alloy containing 6 wt.% Al, 4 wt.% V, and the remainder Ti. Although not illustrated, a refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium (such as a MoRe alloy) will also have greater stiffness and yield strength than a medical device formed of a frame, rod, post, strut, etc. made partially or completely of stainless steel (e.g., 316, 316L, etc.).

[0219] Reference now Figures 6 to 8, there are three graphs illustrating the yield strength, ultimate strength, and fatigue ductility of wires formed from TiAlV alloys, CoCr alloys, and MoRe alloys after such alloys are cold worked to reduce the cross-sectional area of ​​the alloys, and where the wires have the same size, shape, and configuration. After cold working, wires formed from refractory metal alloys or metal alloys containing at least 15 awt.% rhenium (such as MoRe alloys) generally have greater fatigue ductility, yield strength, and ultimate strength than wires of the same shape, size, and configuration formed from CoCr alloys and TiAlV alloys and stainless steel (e.g., 316, 316L, etc.). Moreover, cold working of wires formed from refractory metal alloys or metal alloys containing at least 15 awt.% rhenium (such as MoRe alloys) results in an increase in the ductility of the wires. The graphs illustrate the opposite effects on the ductility of wires formed from CoCr alloys and TiAlV alloys and stainless steel (not shown) after subjecting the wires to additional cold working.

[0220] Reference now Fig. 9 , the hydrophilicity of a wire formed from a refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium (such as a MoRe alloy) was compared to a wire of the same shape, size, and configuration formed from a CoCr alloy or a TiAlV alloy. Fig. 9 As illustrated, the CoCr alloy is a hydrophobic material, resulting in a large contact angle (93°±1°) of a water droplet (e.g., distilled water) positioned on the surface of a wire formed of the CoCr alloy. The TiAlV alloy is a little more hydrophilic than the CoCr alloy, and exhibits a contact angle of 58°±8° when a water droplet is positioned on the surface of a wire formed of the Ti alloy. A refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium (such as a MoRe alloy) has much greater hydrophilicity than a CoCr alloy or a TiAlV alloy. When a water droplet is positioned on the surface of a wire formed of the MoRe alloy, the wire formed of the MoRe alloy has a contact angle of 37°±3°. The surfaces of frames, wires, pillars, piles, etc. formed from refractory metal alloys or metal alloys containing at least 15 awt.% rhenium are generally hydrophilic, wherein the contact angle of a water droplet on the surface of such frames, wires, pillars, piles, etc. is 25°-45° (and all values ​​and ranges therebetween), and typically 30°-42°.

[0221] Reference now Figures 10 to 12 , illustrates a graph and table showing ion release of a refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium, such as a MoRe alloy. Fig.10As exemplified, during the first day of implantation of a medical device comprising a framework, strut, post, wire, etc. formed of a refractory metal alloy or a metal alloy containing at least 15 awt.% rhenium, such as a MoRe alloy (e.g., 40 wt.%-60 wt.% Re and 40 wt.%-60 wt.% Mo) into a patient, the platinum ion release was about 0.244 μg / cm per day. 2 , and the rhenium ion release is about 0.115 μg / cm per day 2 From day 1 to day 3, the release of molybdenum ions was approximately 0.019 μg / cm per day. 2 , and the rhenium ion release is about 0.013 μg / cm per day 2 From the 3rd to the 7th day, the molybdenum ion release was less than 0.001 μg / cm per day. 2 , and the rhenium ion release is about 0.002 μg / cm per day 2 From the 7th to the 15th day, the molybdenum ion release was about 0.002 μg / cm per day. 2 , and the rhenium ion release is less than 0.001 μg / cm per day 2 From the 15th to the 30th day, Mo ion release was about 0.003 μg / cm per day. 2 , and the rhenium ion release is less than 0.001 μg / cm per day 2 The graph illustrates that, after seven days of implantation in tissue, the release of molybdenum and rhenium ions from the MoRe alloy is virtually non-existent.

[0222] Reference now Fig.11 , the graph illustrates that the molybdenum ion release from a MoRe alloy (e.g., 40 wt%-60 wt% Re and 40 wt%-60 wt% Mo) in a frame, strut, post, wire, etc. implanted or otherwise inserted into a patient's body is less than 1.5% of the permitted daily molybdenum exposure during the first day of insertion of the MoRe alloy into the patient's body, and this daily molybdenum ion exposure decreases to 0.04% of the permitted daily exposure after 15 days. Fig.11 It is also illustrated that the rhenium ion release from the MoRe alloy in a frame, strut, post, wire, etc. implanted or otherwise inserted into a patient's body is less than 0.31% of the permitted daily rhenium exposure during the first day of insertion of the MoRe alloy into the patient's body, and that this daily rhenium ion exposure decreases to less than 0.01% of the permitted daily exposure after 15 days.

[0223] Reference now Fig.12 , illustrates a table showing the amount of major metals released into a patient's body from medical devices containing TiAlV, CoCr, stainless steel, and MoRe alloys after such alloys were inserted into the patient's body for 90 days. The medical devices containing these alloys were of the same size, shape, and configuration. Fig.12 As shown in the table of , the amount of molybdenum and rhenium contained in the surrounding structure of MoRe alloys (e.g., 40 wt%-60 wt% Re and 40 wt%-60 wt% Mo) after 90 days is significantly lower than any of the main metals in other alloys. 2 The amount of platinum metal ions per gram of tissue in a MoRe alloy with a dosage of 40 wt% to 60 wt% Re and 40 wt% to 60 wt% Mo is 0.023 μg / g. Therefore, the absolute increase in the amount of platinum metal ions relative to the dosage size of the MoRe alloy in the tissue is 0.82. After 90 days, 0.028 cm in the tissue 2 / g dose of MoRe in units of rhenium metal ions per gram of tissue is 0.014μg / g. Therefore, the absolute increase in Re metal ions relative to the dose size of the MoRe alloy in the tissue is 0.5. Based on the absolute increase in metal ions in the tissue relative to the dose of the metal alloy in the tissue, the molybdenum and rhenium contents in the MoRe alloy in units of tissue after 90 days of implantation of the MoRe alloy in the tissue are both more than 120 times lower than the cobalt or chromium contents in the CoCr alloy, and many times lower than other major metals in other tested alloys. In general, the absolute ion release of the major element (e.g., the major element in the alloy that is at least 2% by weight of the alloy) of the refractory metal alloy or the metal alloy containing at least 15awt.% rhenium relative to the dose of the refractory metal alloy or the metal alloy containing at least 15awt.% rhenium in the tissue after 90 days is at least 120 times less than any major component in these other alloys when a similar dose of TiAlV, CoCr, stainless steel alloy is implanted or otherwise inserted into a patient.

[0224] Therefore, it will be found that the purposes set forth above and those purposes that become clear from the foregoing description are effectively obtained, and since certain changes can be made in the construction set forth without departing from the spirit and scope of the present disclosure, it is desired that all the subject matter contained in the above description and shown in the accompanying drawings should be interpreted as illustrative and not restrictive. The present disclosure has been described with reference to preferred and alternative embodiments. After reading and understanding the detailed discussion of the present disclosure provided herein, modifications and changes will become apparent to those skilled in the art. The present disclosure is intended to include all such modifications and changes, as long as they fall within the scope of the present disclosure. It should also be understood that the following claims are intended to cover all general and specific features of the present disclosure described herein and all statements of the scope of the present disclosure, which statements may fall into the scope according to the language.

Claims

1. A metal rod, the metal rod being formed of a metal alloy and the metal rod being or forming part of a medical device; the metal rod having one or more physical properties that differ along the longitudinal length of the metal, the one or more physical properties being selected from the group consisting of: a) different flexibility or bendability, b) different yield strength, c) different ultimate tensile strength, and d) different metal alloy crystal structures; the one or more different physical properties of the metal rod along the longitudinal length of the metal rod being 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 heating temperatures at different locations along the longitudinal length of the metal rod, II) exposing the metal alloy to the final heating temperatures for different time periods at different locations along the longitudinal length of the metal rod; and / or III) cooling the metal rod at different cooling rates at different locations along the longitudinal length of the metal rod after the final heat treatment process.

2. The metal rod of claim 1, wherein the metal alloy comprises at least 15 awt.% rhenium.

3. The metal rod of claim 1, wherein the metal rod has a constant cross-sectional shape and size along 80%-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 quenching process during the cooling of the metal rod.

5. A method for forming a metal rod having different physical properties along the longitudinal length of the metal rod, the method comprising the steps of: a) providing the metal rod; the metal rod is formed of a metal alloy; and b) subjecting different portions of the metal rod to different final heat treatment processes along the longitudinal length of the metal rod, so that different portions of the metal rod at different longitudinal positions of the metal rod have one or more different physical properties, and the one or more different physical properties are selected from the group consisting of: a) different flexibility or bendability, b) different yield strength, c) different ultimate tensile strength and d) different metal alloy crystal structures; the different final heat treatment processes include I) subjecting the metal alloy to different final heating temperatures at different positions along the longitudinal length of the metal rod, II) exposing the metal alloy to the final heating temperature for different time periods 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.

6. The method of claim 5, wherein the metal alloy comprises at least 15 awt. % rhenium.

7. The method of claim 5, wherein the metal rod has a constant cross-sectional shape and size along 80%-100% of the longitudinal length of the metal rod.

8. The method of claim 5, wherein at least a portion of the metal rod is not subjected to a quenching process during the cooling of the metal rod.

9. The method according to claim 5, wherein the maximum temperature of the final heat treatment is 500°C-1000°C.

10. The method of claim 5, wherein the metal rod is subjected to the final heat treatment process for about 0.5 hours to 25 hours.

11. The method of claim 5, wherein the cooling step cools the metal rod at a rate less than 100°C / s.

12. The method of claim 5, wherein the step of subjecting the metal rod to a final heat treatment process comprises a) initially increasing the temperature around the metal rod from a minimum temperature to a maximum temperature for a first period of time, and b) maintaining the maximum temperature around the metal rod for a second period of time.

13. The method according to claim 12, wherein the minimum temperature is 10°C-250°C; the first time period is 0.5 hours-10 hours; and the second time period is 0.01 hours-15 hours.

14. The method of claim 5, wherein the cooling step occurs in a) a non-oxidizing gas environment at a temperature of 10°C-100°C, b) an inert gas environment at a temperature of 10°C-100°C, or c) an air environment at a temperature of 10°C-100°C.

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

16. A metal rod, the metal rod being formed of a metal alloy and the metal rod being a medical device or forming part of a medical device; the metal rod having one or more physical properties that are different along the longitudinal length of the metal, the one or more physical properties being selected from the group consisting of: a) different flexibility or bendability, b) different yield strength, c) different ultimate tensile strength, and d) different metal alloy crystal structures; the one or more different physical properties of the metal rod along the longitudinal length of the metal rod being 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 heating temperatures at different locations along the longitudinal length of the metal rod, II) exposing the metal alloy to the final heating temperature for different time periods at different locations along the longitudinal length of the metal rod; and / or III) cooling the metal rod at different cooling rates at different locations along the longitudinal length of the metal rod after the final heat treatment process.

17. The metal rod of claim 1, wherein the metal alloy comprises at least 15 awt. % rhenium.

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

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

20. A method for forming a metal rod having different physical properties along the longitudinal length of the metal rod, the method comprising the steps of: a) providing the metal rod; the metal rod is formed of a metal alloy; and b) subjecting different portions of the metal rod to different final heat treatment processes along the longitudinal length of the metal rod, so that different portions of the metal rod at different longitudinal positions of the metal rod have one or more different physical properties, and the one or more different physical properties are selected from the group consisting of: a) different flexibility or bendability, b) different yield strength, c) different ultimate tensile strength and d) different metal alloy crystal structures; the different final heat treatment processes include I) subjecting the metal alloy to different final heating temperatures at different positions along the longitudinal length of the metal rod, II) exposing the metal alloy to the final heating temperature for different time periods 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.

21. The method of claim 5, wherein the metal alloy comprises at least 15 awt. % rhenium.

22. The method of claim 5, wherein the metal rod has a constant cross-sectional shape and size along 80%-100% of the longitudinal length of the metal rod.

23. The method of claim 5, wherein at least a portion of the metal rod is not subjected to a quenching process during the cooling of the metal rod.

24. The method according to claim 5, wherein the maximum temperature of the final heat treatment is 500°C-1000°C.

25. The method of claim 5, wherein the metal rod is subjected to the final heat treatment process for about 0.5 hours to 25 hours.

26. The method of claim 5, wherein the cooling step cools the metal rod at a rate less than 100°C / s.

27. The method of claim 5, wherein the step of subjecting the metal rod to a final heat treatment process comprises a) initially increasing the temperature around the metal rod from a minimum temperature to a maximum temperature for a first period of time, and b) maintaining the maximum temperature around the metal rod for a second period of time.

28. The method according to claim 12, wherein the minimum temperature is 10°C-250°C; the first time period is 0.5 hours-10 hours; and the second time period is 0.01 hours-15 hours.

29. The method of claim 5, wherein the cooling step occurs in a) a non-oxidizing gas environment at a temperature of 10°C-100°C, b) an inert gas environment at a temperature of 10°C-100°C, or c) an air environment at a temperature of 10°C-100°C.

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

31. A spinal surgery material set for use in spinal surgery, the spinal surgery material set comprising: a. a first support rod and a second support rod; each of the first support rod and the second support rod has the same cross-sectional shape and size along the longitudinal length of the first support rod and the second support rod; the first support rod is subjected to different I) final heat treatment time, II) temperature during the final heat treatment and / or III) a different cooling rate to have a different flexibility, bendability, yield strength and / or ultimate tensile strength than the second support rod; the first support rod includes a first rod visual marking; the second support rod includes a second rod visual marking; The first rod visual indicia and the second rod visual indicia are different; and b. a first bone screw and a second bone screw; the first bone screw and the second bone screw each include a threaded lower body portion and an upper portion including a rod fixing arrangement; the body portion of each of the first bone screw and the second bone screw is formed of the same material; the upper portion of each of the first bone screw and the second bone screw is formed of the same material; the rod fixing arrangement in the upper portion of each of the first bone screw and the second bone screw includes a rod slot or a rod opening of the same shape and size; the rod slot or the rod opening on each of the first bone screw and the second bone screw is configured to receive a portion of one of the first support rod or the second support rod; the rod slot or the rod opening on each of the first bone screw and the second bone screw has the same shape and size.

32. A spinal surgical material collection according to claim 16, wherein the main 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 first screw visual mark; the second bone screw includes a second screw visual mark; the first screw visual mark and the second screw visual mark are different.

33. The spinal surgery material set of claim 16, wherein each of the first support rod and the second support rod is formed of a metal alloy; the metal alloy comprising a) stainless steel containing at least 15 awt.% rhenium, b) cobalt-chromium alloy containing at least 15 awt.% rhenium, c) TiNi alloy containing at least 15 awt.% rhenium, d) TiAlV alloy containing at least 15 awt.% rhenium, e) 5 awt.% rhenium, f) an Al alloy containing at least 15 awt.% rhenium, g) a Ni alloy containing at least 15 awt.% rhenium, h) a W alloy containing at least 15 awt.% rhenium, i) a Cu alloy containing at least 15 awt.% rhenium, j) a beryllium-copper alloy containing at least 15 awt.% rhenium, k) at least 30 wt.% of one or more of niobium, tantalum, titanium, cobalt, chromium, zirconium or tungsten; and the metal alloy further includes at least 1 5 awt.% rhenium, l) at least 50 weight % of one or more of niobium, tantalum, titanium, cobalt, chromium, zirconium or tungsten, and the metal alloy further includes 1 weight %-40 weight % 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 the metal alloy further includes at least 1 5 awt.% rhenium, m) at least 60 wt.% tungsten, at least 15 awt.% rhenium, n) at least 60 wt.% tungsten, at least 15 awt.% rhenium and at least 1 wt.% molybdenum, o) at least 50 wt.% rhenium, at least 20 wt.% chromium and 0.1 wt.% 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, zirconium and zirconium oxide, p) greater than 50 wt.% titanium, 15 wt.% to 10 wt.% % to 45 wt% niobium, 1 wt% to 10 wt% zirconium and 1 wt% to 15 wt% tantalum, q) greater than 50 wt% titanium, 15 wt% to 45 wt% niobium and 1 wt% to 10 wt%, r) 30 wt% to 60 wt% cobalt, 10 wt% to 30 wt% chromium, 5 wt% to 20 wt% iron, 5 wt% to 22 wt% nickel and 2 wt% to 12 wt% molybdenum, s) 40 wt% to 60 wt% zirconium and 40 wt% to 60 wt% molybdenum, t) 90 wt% to 99.5 wt% niobium and 0.5 wt% to 10 wt% zirconium, or u) 55 wt% to 75 wt% niobium, 1 8 wt% to 40 wt% tantalum, 1 wt% to 7 wt% tungsten and 0.5 wt% to 4% zirconium.

34. The spinal surgery material set of claim 16, wherein the main body portion of each of the first bone screw and the second bone screw is formed of a metal alloy; the metal alloy comprising a) stainless steel containing at least 15 awt.% rhenium, b) cobalt-chromium alloy containing at least 15 awt.% rhenium, c) TiNi alloy containing at least 15 awt.% rhenium, d) TiAlV alloy containing at least 15 awt.% rhenium, e) Al alloy containing at least 15 awt.% rhenium, f) Ni alloy containing at least 15 awt.% rhenium, g) Ti alloy containing at least 15 awt.% rhenium, h) % rhenium, i) a Cu alloy containing at least 15 awt.% rhenium, j) a beryllium-copper alloy containing at least 15 awt.% rhenium, k) at least 30 wt.% of one or more of niobium, tantalum, titanium, cobalt, chromium, zirconium or tungsten; and the metal alloy further includes at least 15 awt.% rhenium, 1) at least 50 wt.% of one or more of niobium, tantalum, titanium, cobalt, chromium, zirconium or tungsten, and the metal alloy further includes 1 wt.%-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 the metal alloy further comprises at least 15 awt.% rhenium, m) at least 60 wt.% tungsten, at least 15 awt.% rhenium, n) at least 60 wt.% tungsten, at least 15 awt.% rhenium and at least 1 wt.% molybdenum, o) at least 50 wt.% rhenium, at least 20 wt.% chromium and 0.1 wt.% 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, zirconium and zirconium oxide, p) greater than 50 wt.% titanium, 15 wt.% to 45 wt.% % to 10% zirconium and 1% to 15% tantalum, q) greater than 50% titanium, 15% to 45% niobium and 1% to 10% titanium, r) 30% to 60% cobalt, 10% to 30% chromium, 5% to 20% iron, 5% to 22% nickel and 2% to 12% molybdenum, s) 40% to 60% zirconium and 40% to 60% molybdenum, t) 90% to 99.5% niobium and 0.5% to 10% zirconium, or u) 55% to 75% niobium, 18% to 40% tantalum, 1% to 7% tungsten and 0.5% to 4% zirconium.

35. A method for using a spinal surgical material set for use in spinal surgery, the method comprising: a. Providing a first support rod and a second support rod; each of the first support rod and the second support rod having the same cross-sectional shape and size along the longitudinal length of the first support rod and the second support rod; the first support rod having a different flexibility, bendability, yield strength and / or ultimate tensile strength than the second support rod due to the first support rod and the second support rod being subjected to different I) final heat treatment times, II) temperatures during the final heat treatment and / or III) cooling rates; the first support rod comprising a first rod visual indicia; The second support rod includes a second rod visual indicia; the first rod visual indicia and the second rod visual indicia are different; b. providing a first bone screw and a second bone screw; the first bone screw and the second bone screw each include a threaded lower body portion and an upper portion including a rod fixing arrangement; the body portion of each of the first bone screw and the second bone screw is formed of the same material; the upper portion of each of the first bone screw and the second bone screw is formed of the same material; the rod fixing arrangement in the upper portion of each of the first bone screw and the second bone screw includes a rod slot or a rod opening of the same shape and size; the rod slot or the rod opening on each of the first bone screw and the second bone screw is configured to receive a portion of one of the first support rod or the second support rod; the rod slot or the rod opening on each of the first bone screw and the second bone screw has the same shape and size; c. inserting the first bone screw into a first bone in the patient's vertebra; d. inserting the second bone screw into a second bone in the vertebra of the patient; e. determining the desired flexibility of the support device to be connected to the first bone screw and the second bone screw; f. selecting the first support rod or the second support rod to be used as the support device based on the flexibility of the first rod and the second rod and the desired flexibility of the support device; the surgeon can determine the difference in flexibility of the first support rod and the second support rod based on the first rod marking and the second rod marking; g. The rod securing arrangement securing the selected first support rod or second support rod to the first bone screw and the second bone screw.

36. The method of claim 20, wherein the main body portion of the first bone screw has a shape, size and / or longitudinal length that is different from that of the second bone screw; the first bone screw includes a first screw visual marker; the second bone screw includes a second screw visual marker; the first screw visual marker and the second screw visual marker are different; and the method further comprises the steps of: 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 the first bone screw 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 bone screw or second bone screw into the first bone; the surgeon is able to determine the difference in the shape, size and / or longitudinal length of the first bone screw and the second bone screw based on the first screw marker and the second screw marker.

37. The method of claim 20, wherein each of the first support rod and the second support rod is formed of a metal alloy; the metal alloy comprising a) stainless steel containing at least 15 awt.% rhenium, b) cobalt-chromium alloy containing at least 15 awt.% rhenium, c) TiNi alloy containing at least 15 awt.% rhenium, d) TiAlV alloy containing at least 15 awt.% rhenium, e) Al alloy containing at least 15 awt.% rhenium, f) a TiAlV alloy containing at least 15 awt.% rhenium, wt.% rhenium, g) a Ti alloy containing at least 15 awt.% rhenium, h) a W alloy containing at least 15 awt.% rhenium, i) a Cu alloy containing at least 15 awt.% rhenium, j) a beryllium-copper alloy containing at least 15 awt.% rhenium, k) at least 30 wt.% of one or more of niobium, tantalum, titanium, cobalt, chromium, zirconium or tungsten; and the metal alloy further includes at least 15 awt.% rhenium, l) at least 50 wt.% of one or more of niobium, tantalum, titanium, cobalt, chromium, zirconium or tungsten %, and the metal alloy further includes 1 wt.% 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 the metal alloy further includes at least 15 awt.% rhenium, m) at least 60 wt.% tungsten, at least 15 awt.% rhenium, n) at least 60 wt.% tungsten, at least 15 awt.% rhenium and at least 15 awt.% rhenium. o) at least 50% rhenium, at least 20% chromium, and 0.1% to 80% by weight 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 zirconium oxide, p) greater than 50% titanium, 15% to 45% niobium, 1% to 10% zirconium, and 1% to 1 5 wt% tantalum, q) greater than 50 wt% titanium, 1 5-45 wt% niobium and 1 wt%-10 wt%, r) 30-60 wt% cobalt, 10-30 wt% chromium, 5-20 wt% iron, 5-22 wt% nickel and 2-12 wt% molybdenum, s) 40-60 wt% zirconium and 40-60 wt% molybdenum, t) 90-99.5 wt% niobium and 0.5-10 wt% zirconium, or u) 55-75 wt% niobium, 18-40 wt% tantalum, 1-7 wt% tungsten and 0.5-4 wt% zirconium.

38. The method of claim 20, wherein the body portion of each of the first bone screw and the second bone screw is formed of a metal alloy; the metal alloy comprising a) a stainless steel containing at least 15 awt.% rhenium, b) a cobalt-chromium alloy containing at least 15 awt.% rhenium, c) a TiNi alloy containing at least 15 awt.% rhenium, d) a TiAlV alloy containing at least 15 awt.% rhenium, e) an Al alloy containing at least 15 awt.% rhenium, f) a Ni alloy containing at least 15 awt.% rhenium, g) a Ti alloy containing at least 15 awt.% rhenium, h) a W alloy containing at least 15 awt.% rhenium, i) a Cu alloy containing at least 15 awt.% rhenium, j) a Beryllium-Copper alloy containing at least 15 awt.% rhenium, k) at least 30 wt.% of niobium, tantalum, % rhenium, 1) at least 50 wt. % of one or more of niobium, tantalum, titanium, cobalt, chromium, zirconium or tungsten, and the metal alloy further includes 1 wt. % 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 the metal alloy further includes at least 15 awt. % rhenium, m) at least 60 wt. % of tungsten %, at least 15 awt.% rhenium, n) at least 60 wt.% tungsten, at least 15 awt.% rhenium and at least 1 wt.% molybdenum, o) at least 50 wt.% rhenium, at least 20 wt.% chromium and 0.1 wt.% 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, zirconium and zirconium oxide, p) greater than 50 wt.% titanium, 15 wt.% to 45 wt.% niobium, 1 wt.% to 10 wt.% zirconium and 1 wt.% to 15 wt % tantalum, q) greater than 50 wt % titanium, 15 wt %-45 wt % niobium and 1 wt %-10 wt %, r) 30 wt %-60 wt % cobalt, 10 wt %-30 wt % chromium, 5 wt %-20 wt % iron, 5 wt %-22 wt % nickel and 2 wt %-12 wt % molybdenum, s) 40 wt %-60 wt % zirconium and 40 wt %-60 wt % molybdenum, t) 90 wt %-99.5 wt % niobium and 0.5 wt %-10 wt % zirconium, or u) 55 wt %-75 wt % niobium, 18 wt %-40 wt % tantalum, 1 wt %-7 wt % tungsten and 0.5 wt %-4 wt % zirconium.

39. A method for forming a support rod assembly that can be used in a surgical procedure, the method comprising: a. forming a first rod and a second rod; each of the first rod and the second rod has the same cross-sectional shape and size along the longitudinal length of the first rod and the second rod; each of the first rod and the second rod is formed of a metal alloy; the metal alloy used to form the first rod and the second rod is 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 first rod visual marker to the first metal rod; and g. applying a second rod visual marker to the second metal rod; and wherein the first rod visual indicia and the second rod visual indicia are different; and The flexibility, bendability, yield strength and / or ultimate tensile strength of the first metal rod is different from that of the second metal rod due to the fact that 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.

40. The method of claim 24, wherein the final heat treatment process of one or both of the first metal rod and the second metal rod is absent quenching of one or both of the first metal rod and the second metal rod.

41. The method of claim 24, wherein the metal alloy of each of the first support rod and the second support rod comprises a) a stainless steel comprising at least 15 awt.% rhenium, b) a cobalt-chromium alloy comprising at least 15 awt.% rhenium, c) a TiNi alloy comprising at least 15 awt.% rhenium, d) a TiAlV alloy comprising at least 15 awt.% rhenium, e) an Al alloy comprising at least 15 awt.% rhenium, f) a Ni alloy comprising at least 15 awt.% rhenium, g) a Ti alloy comprising at least 15 awt.% rhenium, h) a W alloy comprising at least 15 awt.% rhenium, i) a Ti alloy comprising at least 15 awt.% rhenium, % rhenium, j) a beryllium-copper alloy containing at least 15 awt.% rhenium, k) at least 30 wt.% of one or more of niobium, tantalum, titanium, cobalt, chromium, zirconium or tungsten; and the metal alloy further includes at least 15 awt.% rhenium, 1) at least 50 wt.% of one or more of niobium, tantalum, titanium, cobalt, chromium, zirconium or tungsten, and the metal alloy further includes 1 wt.%-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 the metal The alloy further includes at least 15 awt.% rhenium, m) at least 60 wt.% tungsten, at least 15 awt.% rhenium, n) at least 60 wt.% tungsten, at least 15 awt.% rhenium and at least 1 wt.% molybdenum, o) at least 50 wt.% rhenium, at least 20 wt.% chromium and 0.1 wt.% 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, zirconium and zirconium oxide, p) greater than 50 wt.% titanium, 15 wt.% to 45 wt.% niobium, 1 wt.% to 80 wt.% of one or more of zirconium and zirconium oxide. 10 wt% zirconium and 1 wt%-15 wt% tantalum, q) greater than 50 wt% titanium, 15 wt%-45 wt% niobium and 1 wt%-10 wt%, r) 30 wt%-60 wt% cobalt, 10 wt%-30 wt% chromium, 5 wt%-20 wt% iron, 5 wt%-22 wt% nickel and 2 wt%-12 wt% molybdenum, s) 40 wt%-60 wt% zirconium and 40 wt%-60 wt% molybdenum, t) 90 wt%-99.5 wt% niobium and 0.5 wt%-10% zirconium, or u) 55 wt%-75 wt% niobium, 18 wt%-40 wt% tantalum, 1 wt%-7 wt% tungsten and 0.5 wt%-4% zirconium.

42. The method of claim 24, wherein a maximum temperature of the final heat treatment of one or both of the first metal rod and the second metal rod is 500°C-1000°C.

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

44. The method of claim 24, wherein the step of subjecting the first metal rod to a final heat treatment process comprises a) initially increasing the temperature around the first metal rod from a minimum temperature to a maximum temperature for a first time period, and b) maintaining the maximum temperature around the first metal rod for a second time period; the step of subjecting the second metal rod to a final heat treatment process comprises a) initially increasing the temperature around the second metal rod from a minimum temperature to a maximum temperature for a first time period, and b) maintaining the maximum temperature around the second metal rod for a second time period.

45. The method according to claim 29, wherein for one or both of the first metal rod and the second metal rod, the minimum temperature is 10°C-250°C; for one or both of the first metal rod and the second metal rod, the first time period is 0.5 hours-10 hours; for one or both of the first metal rod and the second metal rod, the second time period is 0.01 hours-15 hours; the first time period and / or the second time period for the first metal rod are different from those for the second metal rod.

46. ​​The method of claim 24, wherein one or both of the first metal rod and the second metal rod are cooled at a rate of less than 100°C / s during the cooling step.

47. The method of claim 31, wherein the cooling step occurs in a) a non-oxidizing gas environment at a temperature of 10°C-100°C, b) an inert gas environment at a temperature of 10°C-100°C, or c) an air environment at a temperature of 10°C-100°C.

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