Medical device metal alloy

Abstract

The present disclosure provides a medical device formed, in part or in whole, from a metal alloy; the metal alloy comprises one of: a) a metal alloy comprising at least 15 atomic weight percent rhenium; b) at least 60 wt% tungsten, at least 15 atomic wt% rhenium and at least 1 wt% molybdenum; c) at least 50% by weight of rhenium, at least 20% by weight of chromium and 0.1-80% by weight of an additive; d) more than 50% by weight of titanium, 15-45% by weight of niobium, 1-10% by weight of zirconium and 1-15% by weight of tantalum; e) greater than 50% by weight of titanium, 15-45% by weight of niobium and 1-10% by weight; f) 30 to 60 wt% cobalt, 10 to 30 wt% chromium, 5 to 20 wt% iron, 5 to 22 wt% nickel and 2 to 12 wt% molybdenum; g) 40-60% by weight of zirconium and 40-60% by weight of molybdenum; h) 90 to 99.5% by weight of niobium and 0.5 to 10% by weight of zirconium; or i) 55-75% by weight niobium, 18-40% by weight tantalum, 1-7% by weight tungsten and 0.5-4% by weight zirconium.

Description

[0001] The present disclosure relates generally to medical devices and medical device applications, and more particularly to medical devices formed at least partially from a biocompatible metal alloy. BACKGROUND

[0002] Stainless steels, cobalt-chrome alloys, and TiAlV alloys are some of the more common metal alloys used for medical devices. Although these alloys have been successfully used to form a variety of medical devices, these alloys still have some drawbacks. Refractory metal alloys and alloys containing rhenium have also been used to form medical devices, in part or in whole.

[0003] Many cardiovascular devices, such as stents, expandable heart valves, and the like, are inserted into a patient via the patient's vasculature and then expanded at a treatment site. These devices are typically crimped onto a catheter prior to insertion into the patient. The smallest diameter that a cardiovascular device can be crimped onto a catheter will set a limit on the size of the cardiovascular passageway (e.g., vessel) into which the cardiovascular device can be inserted. A smaller crimped diameter can result in a reduction of damage to the blood vessels and / or organs (e.g., heart, etc.) when the cardiovascular device is inserted and / or placed at the treatment site. A smaller crimped diameter can also allow the cardiovascular device to be placed in smaller diameter blood vessels (e.g., vessels located in the brain, etc.).

[0004] The crimped diameter of an expandable cardiovascular device can be reduced by reducing the thickness and / or size of the frame, struts, etc. of the cardiovascular device. However, such reductions in size also affect the strength of the cardiovascular device after expansion. After the cardiovascular device is expanded, it must maintain its expanded shape at the treatment region, otherwise the cardiovascular device can move out of the treatment region, can damage the treatment region, and / or can not properly function at the treatment region. Thus, there is a need for cardiovascular devices formed from traditional materials, such as stainless steel [e.g., 316L: 17-19 wt. % chromium, 13-15 wt. % nickel, 2-4 wt. % molybdenum, max 2 wt. % manganese, max 0.75 wt. % silicon, max 0.03 wt. % carbon, balance iron] and cobalt-chromium alloys (e.g., MP35N: 19-21 wt. % chromium, 34-36 wt. % nickel, 9-11 wt. % molybdenum, max 1 wt. % iron, max 1 wt. % titanium, max 0.15 wt. % manganese, max 0.15 wt. % silver, max 0.025 wt. % carbon, balance cobalt) to maintain frame and / or strut size / thickness, which limits how small a crimped diameter can be obtained from a crimped cardiovascular device. Other types of cobalt-chromium alloys that have been used are Phynox and Elgiloy alloys (38-42 wt. % cobalt, 18-22 wt. % chromium, 14-18 wt. % iron, 13-17 wt. % nickel, 6-8 wt. % molybdenum) and L605 alloy (18-22 wt. % chromium, 14-16 wt. % W, 9-11 wt. % nickel, balance cobalt). TiAlV alloys are also used in many medical devices (e.g., Ti-6Al-4V; 5.5-6.5 wt. % Al, 3.5-4.5 wt. % V, and balance Ti; 3.5-4.5 wt. % vanadium, 5.5-6.75 wt. % aluminum, max 0.3 wt. % iron, max 0.2 wt. % oxygen, max 0.08 wt. % carbon, max 0.05 wt. % nitrogen, max 0.015 wt. % hydrogen H, max 0.05 wt. % yttrium, balance titanium).

[0005] Further, conventional materials such as stainless steel (316L) and cobalt-chromium alloys (e.g., MP35N, etc.) have a degree of recoil after crimping and expansion that can hinder achieving a minimum crimped diameter and / or can adversely affect placement of the expandable cardiovascular device at the treatment site. During the crimping process, a crimping device is typically used to crimp the cardiovascular device onto a catheter. After the initial crimping process, conventional materials such as stainless steel and cobalt-chromium alloys recoil to a larger diameter that is more than 9+ % of the minimum crimped diameter. Therefore, the cardiovascular device must be crimped multiple times onto the catheter in an attempt to achieve a smaller crimped diameter on the catheter. However, subjecting the cardiovascular device to multiple crimps can result in damage to the cardiovascular device (e.g., damage to the frame and / or struts of the cardiovascular device, damage to the leaflets on an expandable heart valve, etc.). Likewise, when the cardiovascular device is expanded at the treatment site, the conventional materials of the cardiovascular device will recoil more than 9+ % of the maximum expanded diameter. Therefore, the inflation balloon on the catheter must be pressurized multiple times to repeatedly expand the cardiovascular device at the treatment site to ensure proper inflation of the cardiovascular device. However, subjecting the cardiovascular device to multiple balloon inflations can result in damage to the cardiovascular device (e.g., damage or breakage of the frame and / or struts, etc.) and / or damage to the treatment site (e.g., vessel rupture, tearing and / or puncturing of organ tissue, etc.).

[0006] In view of the state of the art of medical devices, there is a need for an improved medical device that a) produces less recoil than medical devices formed from stainless steel, cobalt-chromium alloys, or TiAlV alloys, and b) can form a smaller crimped diameter than medical devices formed from stainless steel, cobalt-chromium alloys, or TiAlV alloys. SUMMARY

[0007] The present disclosure relates to a medical device made at least partially from a metal alloy. The medical device can include 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; frames and other structures used with spinal implants; 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; any type of implant; a pacemaker; a dental implant; a dental crown; a dental brace; a wire used in a medical procedure; a bone implant; an artificial intervertebral disc; an artificial inter-spinal disc; a prosthetic implant or a structure for repairing, replacing, and / or supporting bone (e.g., acromion, atlas, axis, calcaneus, carpal bone, clavicle, coccyx, humerus, lateral epicondyle, medial epicondyle, femur, fibula, frontal bone, greater trochanter, humerus, ilium, ischium, mandible, maxilla, metacarpal bone, metatarsal bone, occipital bone, olecranon, parietal bone, patella, phalangeal bone, radius, rib, sacrum, scapula, sternum, talus, tarsal bone, temporal bone, tibia, ulna, zygoma, etc.) and / or cartilage; a bone plate; a pin; a rod; a screw; a post; a cage; a plate; a pedicle screw; a cap; a hinge; a joint system; an anchor; a spacer; a shaft; an anchor pin; a disc; a ball; a tension band; a locking connector; other structural components for supporting structures, mounting structures, and / or repairing structures in a body (e.g., a human body, an animal body, etc.). In one non-limiting embodiment, the medical device includes an expandable frame (e.g., a stent, a prosthetic heart valve, etc.) that can be radially plastically deformed outwardly by an expansion device (e.g., an inflatable balloon, etc.). In another non-limiting embodiment, the metal alloy is not a self-expanding alloy.

[0008] According to another and / or alternative non-limiting aspect of the present disclosure, there is provided a medical device formed partially or entirely from a metal alloy, such as but not limited to a modified titanium alloy, a modified cobalt-chromium alloy, a modified zirconium alloy, a modified niobium alloy, a refractory metal alloy, a metal alloy comprising at least 15 atomic wt. % rhenium [e.g., a standard stainless steel alloy comprising at least 15 atomic wt. % rhenium, a standard CoCr alloy comprising at least 15 atomic wt. % rhenium, a standard TiAlV alloy comprising at least 15 atomic wt. % rhenium, a standard Al alloy comprising at least 15 atomic wt. % rhenium, a standard Ni alloy comprising at least 15 atomic wt. % rhenium, a standard Ti alloy comprising at least 15 atomic wt. % rhenium, a standard W alloy comprising at least 15 atomic wt. % rhenium, a standard Mo alloy comprising at least 15 atomic wt. % rhenium, a standard Cu alloy comprising at least 15 atomic wt. % rhenium].

[0009] As defined herein, a standard stainless steel comprises 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% Cb, 0-5 wt% copper, 0-4 wt% aluminum, 0-10 wt% tantalum, 0-1 wt% Se, 0-2 wt% V, 0-2 wt% tungsten, 0-2 wt% Nb, and at least 50 wt% iron.

[0010] As defined herein, a 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% Al, 0-1 wt% Fe, 30-68 wt% cobalt.

[0011] As defined herein, a standard TiAlV alloy comprises 5.5-6.75 wt% Al, 3.5–4.5 wt% V, 85-93 wt% Ti, 0-0.4 wt% iron, 0-0.2 wt% carbon.

[0012] As defined herein, a standard Al alloy comprises 80-99 wt% Al, 0-12 wt% Si, 0-5 wt% Mg, 0-1 wt% Mn, 0-0.5 wt% Sc, 0-0.5 wt% Be, 0-0.5 wt% Y, 0-0.5 wt% Ce, 0-0.5 wt% Cr, 0-3 wt% Fe, 0-0.5, 0-9 wt% Zn, 0-0.5 wt% Ti, 0-3 wt% Li, 0-0.5 wt% Ag, 0-0.5 wt% Ca, 0-0.5 wt% Zr, 0-1 wt% Pb, 0-0.5 wt% Cd, 0-0.05 wt% Bi, 0-1 wt% Ni, 0-0.2 wt% V, 0-0.1 wt% Ga, and 0-7 wt% Cu.

[0013] As defined herein, a standard Ni alloy comprises 30-98 wt% Ni, 5-25 wt% Cr, 0-65 wt% Fe, 0-30 wt% Mo, 0-32 wt% Cu, 0-32 wt% Co, 2-2 wt% Al, 0-6 wt% Ta, 0-15 wt% W, 0-5 wt% Ti, 0-6 wt% Nb, and 0-3 wt% Si.

[0014] As defined herein, a standard Ti alloy comprises 80-99 wt% Ti, 0-6 wt% Al, 0-3 wt% Sn, 0-1 wt% Pd, 0-8 wt% V, 0-15 wt% Mo, 0-1 wt% Ni, 0-0.3 wt% Ru, 0-6 wt% Cr, 0-4 wt% Zr, 0-4 wt% Nb, 0-1 wt% Si, 0.0.5 wt% Co, 0-2 wt% Fe.

[0015] As defined herein, a standard W alloy comprises 85-98 wt% W, 0-8 wt% Ni, 0-5 wt% Cu, 0-5 wt% Mo, 0-4 wt% Fe.

[0016] As defined herein, a standard Mo alloy comprises 90-99.5 wt% Mo, 0-1 wt% Ni, 0-1 wt% Ti, 0-1 wt% Zr, 0-30 wt% W, 0-2 wt% Hf, 0-2 wt% La.

[0017] As defined herein, a standard Cu alloy comprises 55-95 wt% Cu, 0-40 wt% Zn, 0-10 wt% Sn, 0-10 wt% Pb, 0-1 wt% Fe, 0-5 wt% Si, 0-12 wt% Mn, 0-12 wt% Al, 0-3 wt% Be, 0-1 wt% Co, 0-20 wt% Ni.

[0018] 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.

[0019] Below are set forth in weight percent several non-limiting examples of metal alloys that can be used to partially or completely form a frame of a medical device:

[0020]

[0021]

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[0059] In instances 1-210, it is to be understood that all of the above ranges include any value between the range and any other range set forth above. Any of the above values including the < symbol includes a range from 0 to the stated value and all values and ranges therebetween.

[0060] According to another and / or alternative non-limiting aspect of the present disclosure, the medical device is generally designed to include at least about 5% by weight of a metal alloy (e.g., 5 to 100% by weight and all values and ranges therebetween). In one non-limiting embodiment of the present disclosure, the medical device includes at least about 50% by weight of a metal alloy. In another non-limiting embodiment of the present disclosure, the medical device includes at least about 95% by weight of a metal alloy. In one particular construction, when the medical device includes an expandable frame, the expandable frame is formed from 50 to 100% by weight of a metal alloy (and all values and ranges therebetween) of a metal alloy, and is generally 75 to 100% by weight of a metal alloy.

[0061] According to another and / or alternative non-limiting aspects of the present disclosure, there is provided a medical device made partially or entirely from a metal alloy that includes a sufficient amount of rhenium to produce a "rhenium effect" in the metal alloy. As defined herein, a "rhenium effect" is a) at least a 10% increase in ductility of the metal alloy resulting from the addition of rhenium to the metal alloy and / or b) at least a 10% increase in tensile strength of the metal alloy resulting from the addition of rhenium to the metal alloy. It has been discovered that many metal alloys result in improved ductility and / or tensile strength. It has been discovered that the addition of rhenium to a metal alloy can result in the formation of a twinned alloy in the metal alloy that results in an overall increase in ductility of the metal alloy with an increase in yield strength and tensile strength due to the 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 at.% - 99 at.% 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 appear when the stainless steel alloy is modified to include a rhenium amount of at least 5-10 wt.% (and all values and ranges therebetween) of the stainless steel alloy. For a standard CoCr alloy, the "rhenium effect" can 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" can 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 can be appreciated that the rhenium content in the above examples can be greater than the minimum amount used to produce the "rhenium effect" in the metal alloy.

[0062] According to another and / or alternative non-limiting aspects of the present disclosure, there is provided a medical device made from 50-100% (and all values and ranges therebetween) of a metal alloy comprising a sufficient amount of rhenium to produce a "rhenium effect" in the metal alloy. In one non-limiting embodiment, the metal alloy comprises at least 15 atomic weight percent rhenium (e.g., 15-99.9 atomic weight percent and all values and ranges therebetween) and at least 0.1 weight percent (e.g., 0.1 weight percent to 96 weight percent 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 comprises at least 15 atomic weight percent rhenium (e.g., 15-99.9 atomic weight percent and all values and ranges therebetween) and at least 0.1 weight percent (e.g., 0.1 weight percent to 96 weight percent 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 comprises at least 15 atomic weight percent rhenium (e.g., 15-99.9 atomic weight percent and all values and ranges therebetween) and at least 0.1 weight percent (e.g., 0.1 weight percent to 96 weight percent 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.

[0063] In another and / or alternative non-limiting aspects of the present disclosure, the metal alloy optionally comprises less than about 5 weight percent (e.g., 0-4.999999 weight percent and all values and ranges therebetween) of other metals and / or impurities, typically 0-1 weight percent, more typically 0-0.1 weight percent, even more typically 0-0.01 weight percent, and yet even more typically 0-0.001 weight percent. High purity levels of the metal alloy result in a more homogenous alloy, which in turn results in a more uniform density throughout the metal alloy, and also results in a desired yield strength and ultimate tensile strength of the metal alloy.

[0064] According to another and / or alternative non-limiting aspects of the present disclosure, at least 30 weight percent (e.g., 30-100 weight percent and all values and ranges therebetween) of the metal alloy includes one or more of molybdenum, niobium, rhenium, tantalum, or tungsten. In another non-limiting embodiment, at least 40 weight percent of the metal alloy includes one or more of molybdenum, niobium, rhenium, tantalum, or tungsten. In another non-limiting embodiment, at least 50 weight percent of the metal alloy includes one or more of molybdenum, niobium, rhenium, tantalum, or tungsten.

[0065] In another non-limiting embodiment, at least 50 weight percent (e.g., 50-100 weight percent and all values and ranges therebetween) of the metal alloy includes one or more of molybdenum, niobium, rhenium, tantalum, titanium, zirconium, or tungsten, and 1-40 weight percent (and all values and ranges therebetween) of the metal alloy includes one or more additives selected from the group of: aluminum, bismuth, calcium, carbon, cerium oxide, chromium, cobalt, copper, gold, hafnium, iridium, iron, lanthanum, lanthanum oxide, lead, magnesium, manganese, nickel, osmium, platinum, rare earth metals, rhodium, ruthenium, silver, technetium, vanadium, yttrium, yttrium oxide, zinc, and / or zirconium oxide.

[0066] According to another and / or alternative non-limiting aspects of the present disclosure, a metal alloy is provided, wherein at least 20 weight percent (e.g., 20-99 weight percent and all values and ranges therebetween) of the metal alloy includes rhenium. In one non-limiting embodiment, the metal alloy includes at least 20 weight percent (e.g., 20-99.9 weight percent and all values and ranges therebetween) of rhenium and 0.1-80 weight percent (and all values and ranges therebetween) of one or more additives selected from the group of: aluminum, bismuth, calcium, carbon, cerium oxide, chromium, cobalt, copper, gold, hafnium, iridium, iron, lanthanum, lanthanum oxide, lead, magnesium, manganese, 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.

[0067] In another non-limiting aspect of the present disclosure, the metal for forming the metal alloy includes 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.). In one non-limiting formulation, the metal alloy includes up to 40 wt% rhenium and at least 60 wt% tungsten. In one non-limiting embodiment, the total weight percent of tungsten and rhenium in the tungsten-rhenium alloy is at least about 95 wt%, typically at least about 99 wt%, more typically at least about 99.5 wt%, yet more typically at least about 99.9 wt%, and again more typically at least about 99.99 wt%. In another non-limiting formulation, the metal alloy includes up to 47.5 wt% rhenium and at least 20 wt% - 80 wt% tungsten (and all values and ranges therebetween) and 1 wt% - 47.5 wt% molybdenum (and all values and ranges therebetween).

[0068] In accordance with another and / or alternative non-limiting aspect of the present disclosure, at least 35 wt% (e.g., 35 - 75 wt% and all values and ranges therebetween) of the metal alloy includes rhenium, and the metal alloy further includes chromium. In one non-limiting embodiment, at least 25 wt% (e.g., 25 wt% - 49.9 wt% and all values and ranges therebetween) of the metal alloy includes chromium. In another non-limiting embodiment, at least 30 wt% of the metal alloy includes chromium. In another non-limiting embodiment, at least 33 wt% of the metal alloy includes chromium. In another non-limiting embodiment, at least 50 wt% (e.g., 50 - 74.9 wt% and all values and ranges therebetween) of the metal alloy includes rhenium, at least 25 wt% (e.g., 25 - 49.9 wt% and all values and ranges therebetween) of the metal alloy includes chromium, and 0.1 - 25 wt% (and all values and ranges therebetween) of the metal alloy includes 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, at least 55 wt% (e.g., 55 wt% - 69.9 wt% and all values and ranges therebetween) of the metal alloy includes rhenium, at least 30 wt% (e.g., 30 wt% - 44.9 wt% and all values and ranges therebetween) of the metal alloy includes chromium, and 0.1 wt% - 15 wt% (and all values and ranges therebetween) of the metal alloy includes one or more of molybdenum, bismuth, niobium, tantalum, titanium, vanadium, tungsten, manganese, zirconium, technetium, ruthenium, rhodium, hafnium, osmium, copper, yttrium, zirconium, and / or iridium.

[0069] According to another and / or alternative non-limiting aspects of the present disclosure, the metal alloy includes 10-60 atomic weight percent (atomic wt. %) Re (and all values and ranges therebetween) and one or more metals selected from the group consisting of Mo, Cr, Ta, Nb, Ti, and Zr. In one non-limiting embodiment, the metal alloy includes 15-60 atomic wt. % 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 includes 15-60 atomic wt. % Re and one or more metals selected from the group consisting of 0.5-70 atomic wt. % Cr (and all values and ranges therebetween), 0.5-70 atomic wt. % Ta (and all values and ranges therebetween), 0.5-70 atomic wt. % Nb (and all values and ranges therebetween), 0.5-70 atomic wt. % Ti (and all values and ranges therebetween), and 0.5-70 atomic wt. % Zr (and all values and ranges therebetween).

[0070] According to another and / or alternative non-limiting aspects of the present disclosure, the metal alloy includes 0.5-50 atomic wt. % Re (and all values and ranges therebetween) and 0.5-70 atomic wt. % Cr (and all values and ranges therebetween).

[0071] According to another and / or alternative non-limiting aspects of the present disclosure, the metal alloy includes 0.5-50 atomic wt. % Re (and all values and ranges therebetween) and 0.5-70 atomic wt. % Ta (and all values and ranges therebetween).

[0072] According to another and / or alternative non-limiting aspects of the present disclosure, the metal alloy includes 0.5-50 atomic wt. % Re (and all values and ranges therebetween) and 0.5-70 atomic wt. % Nb (and all values and ranges therebetween).

[0073] According to another and / or alternative non-limiting aspects of the present disclosure, the metal alloy includes 0.5-50 atomic wt. % Re (and all values and ranges therebetween) and 0.5-70 atomic wt. % Ti (and all values and ranges therebetween).

[0074] According to another and / or alternative non-limiting aspect of the present disclosure, the metal alloy includes 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 and ranges therebetween) zirconium, and 1 wt. % - 15 wt. % (and all values and ranges therebetween) tantalum. In one non-limiting formulation, the metal alloy includes 58 wt. % - 70 wt. % titanium, 27 wt. % - 37 wt. % niobium, 2 wt. % - 9 wt. % zirconium, and 1 wt. % - 15 wt. % tantalum.

[0075] According to another and / or alternative non-limiting aspect of the present disclosure, the metal alloy includes 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 includes 58 wt. % - 69 wt. % titanium, 27 wt. % - 33 wt. % niobium, and 4 wt. % - 8 wt. % molybdenum.

[0076] According to another and / or alternative non-limiting aspect of the present disclosure, the metal alloy includes 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 includes 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.

[0077] According to another and / or alternative non-limiting aspect of the present disclosure, the metal alloy includes 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 includes 45 wt. % - 55 wt. % cobalt and 45 wt. % - 55 wt. % molybdenum.

[0078] According to another and / or alternative non-limiting aspect of the present disclosure, the metal alloy includes 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 includes 95 wt. % - 99.25 wt. % niobium and 0.75 wt. % - 4 wt. % zirconium.

[0079] According to another and / or alternative non-limiting aspect of the present disclosure, the metal alloy includes 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 includes 60 wt% - 70 wt% niobium, 24 wt% - 32 wt% tantalum, 2 wt% - 5 wt% tungsten, and 0.75 wt% - 3 wt% zirconium.

[0080] According to another and / or alternative non-limiting aspect of the present disclosure, the metal alloy includes less than about 5 wt% (e.g., 0 - 4.999999 wt% and all values and ranges therebetween) of other metals and / or impurities. The high purity level of the metal alloy results in a more homogenous 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. In one non-limiting embodiment, the metal alloy includes less than about 0.5 wt% of other metals and / or impurities. In another non-limiting embodiment, the metal alloy includes less than about 0.2 wt% of other metals and / or impurities. In another non-limiting embodiment, the metal alloy includes less than about 0.1 wt% of other metals and / or impurities. In another non-limiting embodiment, the metal alloy includes less than about 0.05 wt% of other metals and / or impurities. In another non-limiting embodiment, the metal alloy includes less than about 0.01 wt% of other metals and / or impurities.

[0081] According to another and / or alternative non-limiting aspect of the present disclosure, the medical device is generally designed to include at least about 5 wt% of the metal alloy (e.g., 5 to 100 wt% and all values and ranges therebetween). In one non-limiting embodiment of the present disclosure, the medical device includes at least about 50 wt% of the metal alloy. In another non-limiting embodiment of the present disclosure, the medical device includes at least about 95 wt% of the metal alloy. In one particular construction, when the medical device includes an expandable frame, the expandable frame is formed from 50 to 100 wt% (and all values and ranges therebetween) of the metal alloy of the metal alloy, and is generally 75 to 100 wt% of the metal alloy.

[0082] According to another and / or alternative non-limiting aspect of the present disclosure, the metal alloy can optionally be nitrided; however, this is not required. The nitrided layer on the metal alloy can act as a lubricating surface during optional drawing of the metal alloy when partially or fully forming a medical device. After nitriding the metal alloy, the metal alloy is typically cleaned; however, this is not required. During the nitriding process, the surface of the metal alloy is modified by the presence of nitrogen. The nitriding process can employ gas nitriding, salt bath nitriding, or plasma nitriding. In gas nitriding, nitrogen diffuses onto the surface of the metal alloy, creating a nitrided layer. The thickness and phase composition of the resulting nitrided layer can be selected and the process optimized for the particular properties desired. During gas nitriding, the metal alloy is typically nitrided in the presence of nitrogen gas or a nitrogen gas mixture (e.g., 90 to 99 vol% N and 1 to 10 vol% H, etc.) at a temperature of at least about 400 °C (e.g., 400 °C to 1000 °C and all values and ranges therebetween) for at least 10 seconds. In one non-limiting nitriding process, the metal alloy is heated to a temperature of at least 400 °C, and typically about 400 °C to 800 °C (and all values and ranges therebetween), in the presence of nitrogen gas or a nitrogen-hydrogen mixture for at least 10 seconds (e.g., 10 seconds to 60 minutes and all values and ranges therebetween), and typically about 1 to 30 minutes. In salt bath nitriding, a nitrogen-containing salt, such as a cyanide salt, is used. During salt bath nitriding, the metal alloy is typically exposed to a temperature of about 520 °C to 590 °C. In plasma nitriding, the gas used for plasma nitriding is typically pure nitrogen. Plasma nitriding is typically combined with a physical vapor deposition (PVD) process; however, this is not required. Plasma nitriding of the metal alloy typically occurs at a temperature of 220 °C to 630 °C (and all values and ranges therebetween). Prior to the nitriding process, the metal alloy can optionally be exposed to argon and / or hydrogen to clean and / or pre-heat the metal alloy. These gases can optionally be used to remove an oxide layer and / or solvents from the surface of the metal alloy. During the nitriding process, the metal alloy can optionally be exposed to hydrogen to inhibit or prevent the formation of oxides on the surface of the metal alloy. The thickness of the nitrided surface layer is less than about 1 mm. In one non-limiting embodiment, the thickness of the nitride surface layer is at least about 50 nanometers and less than about 1 mm (and all values and ranges therebetween). In another non-limiting embodiment, the thickness of the nitrided surface layer is at least about 50 nanometers and less than about 0.1 mm. Typically, the weight percent of nitrogen in the nitrided surface layer is 0.0001-5 wt% nitrogen (and all values and ranges therebetween). In one non-limiting embodiment, the weight percent of nitrogen in the nitrided surface layer is typically less than one of the major components of the metal alloy, and typically less than each of the two major components of the metal alloy. For example, when the metal alloy is nitrided, the weight percent of nitrogen in the nitrided surface layer is less than the weight percent of rhenium in the nitrided surface layer.In one non-limiting composition of a nitrided surface layer on a metal alloy (e.g., 47 to 55 wt% rhenium, 10 to 46 wt% molybdenum, 0.1 to 30 wt% additional metal alloying agent), the nitrided surface layer includes at least 40 wt% rhenium, at least 8 wt% molybdenum, and 0.0001 to 5 wt% nitrogen (and all values and ranges therebetween). In one non-limiting embodiment of the present disclosure, the surface of the metal alloy is nitrided prior to at least one drawing step of the metal alloy. In another non-limiting aspect of the present disclosure, the metal alloy is nitrided prior to drawing after the metal alloy has been annealed. In another and / or alternative non-limiting embodiment, the metal alloy is cleaned to remove nitride compounds on the surface of the metal alloy prior to annealing the metal alloy. The nitride compounds can be removed by a variety of steps such as, but not limited to, sandblasting, polishing, etc. The metal alloy can be nitrided again prior to one or more drawing steps after the metal alloy has been annealed; however, this is not required. As should be appreciated, the entire outer surface of the metal alloy can be nitrided or a portion of the outer surface of the metal alloy can be nitrided. Different surface properties of the metal alloy can be obtained using nitriding only to selected portions of the outer surface of the metal alloy; however, this is not required. As should be appreciated, the final formed metal alloy can include a nitrided outer surface. The nitriding process for the metal alloy can be used to increase the surface hardness and / or wear resistance of the medical device and / or inhibit or prevent discoloration of the metal alloy (e.g., discoloration from oxidation, etc.). For example, the nitriding process can be used to increase the wear resistance of a mating surface or surface wear on a metal alloy used in a medical device to extend the life of the medical device and / or increase the wear life of a mating surface on the medical device (e.g., a polyethylene liner of a joint implant such as a knee, hip, shoulder, etc.) and / or reduce particulate generation from use of the medical device and / or maintain the outer surface appearance of the metal alloy on the medical device.

[0083] According to another and / or alternative non-limiting aspect of the present disclosure, the metal alloy can optionally be cleaned, polished, sterilized, nitrided, etc. for final processing of the metal alloy, either just prior to or just after being partially or fully formed into the desired medical device. In one non-limiting embodiment of the present disclosure, the metal alloy is electropolished. In one non-limiting aspect of this embodiment, the metal alloy is cleaned prior to being exposed to the polishing solution; however, this is not required. The cleaning process, when used, can be accomplished by various techniques such as, but not limited to, 1) using a solvent (e.g., acetone, methanol, etc.) and wiping the metal alloy with a Kimwipe or other suitable towel and / or 2) at least partially immersing or submerging the metal alloy in the solvent followed by ultrasonic cleaning of the metal alloy. As should be appreciated, the metal alloy can be cleaned by other or additional means. In another and / or alternative non-limiting aspect of this embodiment, the polishing solution can include one or more acids. In yet another and / or alternative non-limiting aspect of this embodiment, the metal alloy is rinsed with water and / or a solvent and allowed to dry to remove the polishing solution therefrom.

[0084] According to another and / or alternative non-limiting aspect of the present disclosure, the medical device can optionally contain and / or be coated with one or more agents that facilitate the success of the medical device and / or the treatment area. The term "agent" includes, but is not limited to, substances, drugs, biologicals, veterinary products, pharmaceuticals, and the like 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 for promoting healing. Non-limiting examples of clinical events that can be addressed by one or more agents include, but are not limited to, viral, fungal, and / or bacterial infections; vascular diseases and / or disorders, digestive system diseases and / or disorders, reproductive system diseases and / or disorders, lymphatic diseases and / or disorders, cancer, implant rejection, pain, nausea, swelling, arthritis, bone diseases and / or disorders, organ failure, immune diseases and / or disorders, cholesterol problems, blood diseases and / or disorders, lung diseases and / or disorders, heart diseases and / or disorders, brain diseases and / or disorders, neuropathic pain diseases and / or disorders, kidney diseases and / or disorders, ulcers, liver diseases and / or disorders, intestinal diseases and / or disorders, gallbladder diseases and / or disorders, pancreatic diseases and / or disorders, psychological disorders, respiratory system diseases and / or disorders, gland diseases and / or disorders, skin diseases and / or disorders, hearing diseases and / or disorders, oral diseases and / or disorders, nasal diseases and / or disorders, eye diseases and / or disorders, fatigue, genetic diseases and / or disorders, burns, scarring and / or scars, trauma, weight diseases and / or disorders, addiction diseases and / or disorders, hair loss, spasticity, muscle spasms, tissue repair, nerve repair, nerve regeneration, and the like. The type and / or amount of agent included in the medical device and / or coated on the medical device can vary. When two or more agents are included in the medical device and / or coated on the medical device, the amount of the two or more agents can be the same or different. The one or more agents can be coated on the medical device and / or impregnated in the medical device by a variety of mechanisms, such as, but not limited to, spray coating (e.g., atomized spray techniques, etc.), flame spraying, powder deposition, dip coating, flow coating, dip spin coating, roll coating (direct and reverse), sonication, brushing, plasma deposition, deposition by vapor deposition, MEMS techniques, and rotational mold deposition. In another and / or alternative non-limiting embodiment of the present disclosure, the type and / or amount of agent included on, in, and / or with the medical device is generally selected for the treatment of one or more medical treatments. The amount of two or more agents used on, in, and / or with the medical device can be the same or different. When used on and / or in the medical device, the one or more agents can optionally be released in a controlled manner such that a desired dosage of the agent is provided to the area to be treated over a sustained period of time. As should be appreciated, controlled release of the one or more agents on the medical device is not always necessary and / or desirable.Accordingly, one or more of the agents on and / or in the medical device can be uncontrollably released from the medical device during and / or after insertion of the medical device into the treatment area. It is also to be appreciated that one or more agents on and / or in the medical device can be controllably released from the medical device and one or more agents on and / or in the medical device can be uncontrollably released from the medical device. It is also to be appreciated that one or more agents on and / or in one region of the medical device can be controllably released from the medical device and one or more agents on and / or in the medical device can be uncontrollably released from another region on the medical device. Accordingly, the medical device can be designed such that 1) all of the agents on and / or in the medical device are controllably released, 2) some of the agents on and / or in the medical device are controllably released and some are uncontrollably released or 3) all of the agents on and / or in the medical device are uncontrollably released. The medical device can also be designed such that the release rate of the one or more agents from the medical device is the same or different. The medical device can also be designed such that the release rate of the one or more agents from one or more regions on the medical device is the same or different. Non-limiting arrangements that can be used to control the release of the one or more agents from the medical device include: 1) at least partially coating the one or more agents with one or more polymers, 2) at least partially incorporating and / or at least partially encapsulating the one or more agents into and / or with one or more polymers and / or 3) inserting the one or more agents into a hole, channel, cavity, etc. in the medical device and at least partially coating or covering such hole, channel, cavity, etc. with one or more polymers. As should be appreciated, other or additional arrangements can be used to control the release of the one or more agents from the medical device. When used to at least partially control the release of the one or more agents from the medical device, the one or more polymers can be porous or non-porous. The one or more agents can be inserted and / or applied to and / or used to at least partially form one or more surface structures and / or microstructures on the medical device. Accordingly, the one or more agents on the medical device can be: 1) coated on one or more surface regions of the medical device, 2) inserted and / or impregnated in one or more surface structures and / or microstructures, etc. on the medical device and / or 3) form at least a portion of a structure of the medical device or be included in at least a portion of a structure of the medical device.When one or more formulations are coated on a medical device, the one or more formulations can be: 1) coated directly on one or more surfaces of the medical device, 2) mixed with one or more coating polymers or other coating materials and then at least partially coated on one or more surfaces of the medical device, 3) at least partially coated on the surface of another coating material that has been at least partially coated on the medical device, and / or 4) at least partially encapsulated: a) between a surface or region of the medical device and one or more other coating materials and / or b) between two or more other coating materials. As should be appreciated, many other coating arrangements can additionally or alternatively be used. When one or more formulations are optionally intercalated and / or impregnated in one or more internal structures, surface structures, and / or microstructures of the medical device, 1) one or more other coating materials can be at least partially applied over the one or more internal structures, surface structures, and / or microstructures of the medical device and / or 2) one or more polymers can be combined with the one or more formulations. Thus, the one or more formulations can be: 1) embedded in a structure of the medical device, 2) positioned in one or more internal structures of the medical device, 3) encapsulated between two polymeric coatings, 4) encapsulated between a base structure and a polymeric coating, 5) mixed in a base structure of the medical device that includes at least one polymeric coating, or 6) one or more combinations of 1, 2, 3, 4, and / or 5. Additionally or alternatively, one or more coatings of one or more polymers on the medical device can include: 1) one or more coatings of non-porous polymers, 2) one or more coatings of a combination of one or more porous polymers and one or more non-porous polymers, 3) one or more coatings of porous polymers, or 4) one or more combinations of options 1, 2, and 3. As should be appreciated, different formulations can optionally be located in and / or between different polymeric coatings and / or on structures of the medical device. As should also be appreciated, many other and / or additional coating combinations and / or configurations can be used. The concentration of the one or more formulations, the type of polymer, the type and / or shape of internal structures in the medical device, and / or the coating thickness of the one or more formulations can be used to control the release time, release rate, and / or dosage of the one or more formulations; however, other or additional combinations can also be used. Thus, the formulation and polymer system combinations and locations on the medical device can be numerous. As should also be appreciated, the one or more formulations can be deposited on a top surface of the medical device to provide an initial uncontrolled burst effect of the one or more formulations prior to: 1) a controlled release of the one or more formulations through one or more layers of a polymer system that includes one or more non-porous polymers and / or 2) an uncontrolled release of the one or more formulations through one or more layers of a polymer system.One or more formulations and / or polymers can be coated on a medical device by a variety of mechanisms, such as but not limited to, spraying (e.g., atomized spray techniques, etc.), dip coating, roll coating, sonication, brushing, plasma deposition, and / or deposition by vapor deposition.

[0085] According to another and / or alternative non-limiting aspects of the present disclosure, a variety of polymers can be optionally coated on and / or used to form at least a portion of a medical device. One or more polymers can be used on a medical device for a variety of reasons, such as but not limited to: 1) forming a portion of the medical device, 2) improving the physical properties of the medical device (e.g., increasing strength, increasing durability, increasing biocompatibility, reducing friction, etc.), 3) forming a protective coating on one or more surface structures on the medical device, 4) at least partially forming one or more surface structures on the medical device, and / or 5) at least partially controlling the release rate of one or more formulations from the medical device. As should be appreciated, one or more polymers can have other or additional uses on a medical device. One or more polymers can be porous, non-porous, biostable, biodegradable (i.e., dissolve, degrade, be absorbed, or any combination thereof within the body), and / or biocompatible. When a medical device is coated with one or more polymers, the polymer(s) can include: 1) one or more coatings of a non-porous polymer, 2) one or more coatings of a combination of one or more porous polymers and one or more non-porous polymers, 3) one or more coatings of one or more porous polymers and one or more coatings of one or more non-porous polymers, 4) one or more coatings of a porous polymer, or 5) one or more combinations of options 1, 2, 3, and 4. The thickness of one or more of the polymer layers can be the same or different. When one or more polymer layers are coated onto at least a portion of a medical device, the one or more coatings can be applied by a variety of techniques, such as but not limited to, vapor and / or plasma deposition, spraying, dip coating, roll coating, sonication, atomization, brushing, etc.; however, other or additional coating techniques can also be used. One or more polymers that can be coated on and / or used to at least partially form a medical device can be a polymer that is considered biodegradable, bioabsorbable, or bioerodible; a polymer that is considered biostable; and / or can be made biodegradable and / or bioabsorbable by modification. The thickness of each polymer layer is typically at least about 0.01 pm and typically less than about 150 pm (e.g., 0.01 pm to 150 pm and all values and ranges therebetween); however, other thicknesses can also be used. In one non-limiting embodiment, the thickness of the polymer layer and / or the formulation layer is about 0.02 to 75 pm, more particularly about 0.05 to 50 pm, and even more particularly about 1 to 30 pm. As should be appreciated, other thicknesses can be used.

[0086] According to another and / or alternative non-limiting aspect of the present disclosure, a medical device, when including and / or coated with one or more formulations, can include and / or can be coated with one or more formulations that are the same or different in different regions of the medical device and / or have different amounts and / or concentrations in different regions of the medical device. For example, a medical device can: 1) be coated with and / or include one or more biological agents on at least a portion of the medical device, and at least another portion of the medical device is not coated with and / or does not include a formulation; 2) be coated with and / or include one or more biological agents on at least a portion of the medical device that is different from one or more biological agents on at least another portion of the medical device; and / or 3) be coated with and / or include one or more biological agents on at least a portion of the medical device that has a different concentration than one or more biological agents on at least another portion of the medical device.

[0087] According to another and / or alternative non-limiting aspect of the present disclosure, one or more portions of a medical device can optionally: 1) include the same or different formulations, 2) include the same amount or different amounts of one or more formulations, 3) include the same or different polymeric coatings, 4) include the same or different coating thicknesses of one or more polymeric coatings, 5) controllably release and / or uncontrollably release one or more formulations from one or more portions of the medical device, and / or 6) controllably release one or more formulations from one or more portions of the medical device, and uncontrollably release one or more formulations from one or more portions of the medical device.

[0088] According to another and / or alternative non-limiting aspect of the present disclosure, a medical device can optionally include a marker material that facilitates enabling the medical device to be properly positioned in a body passageway. The marker material is typically designed to be visible to: electromagnetic waves (e.g., x-rays, microwaves, visible light, infrared waves, ultraviolet waves, etc.); acoustic waves (e.g., ultrasound waves, etc.); magnetic waves (e.g., MRI, etc.); and / or other types of electromagnetic waves (e.g., microwaves, visible light, infrared waves, ultraviolet waves, etc.). The marker material can form all or a portion of the medical device and / or be coated on one or more portions of the medical device (on the flared portion and / or the body portion, at the end of the medical device, at or near the transition of the body portion and the flared portion, etc.). The marker material can be located at one or more locations on the medical device. The size of one or more regions including the marker material can be the same or different. The marker material can be spaced apart from each other by a defined distance to form a ruler-like marker on the medical device to facilitate positioning the medical device in a body passageway. The marker material can be a rigid or flexible material. The marker material can be a biostable or biodegradable material.

[0089] According to another and / or alternative non-limiting aspect of the present disclosure, the medical device or one or more regions of the medical device can optionally be fabricated by using one or more microelectromechanical fabrication (MEMS) techniques (e.g., micromachining, laser micromachining, micro-molding, etc.); however, other or additional fabrication techniques can be used.

[0090] According to another and / or alternative non-limiting aspect of the present disclosure, the medical device can optionally include one or more surface structures (e.g., holes, channels, dimples, ribs, slots, notches, bumps, teeth, needles, wells, pockets, grooves, etc.). These structures can be formed at least in part by MEMS (e.g., micromachining, etc.) techniques and / or other types of techniques.

[0091] According to another and / or alternative non-limiting aspect of the present disclosure, a medical device can optionally include one or more microstructures (e.g., microneedles, microwells, microcolumns, microcones, micropyramids, microtubes, microparallepipeds, microprisms, microhemispheres, teeth, ribs, ridges, ratchets, hinges, zippers, banderol structures, etc.) located on a surface of the medical device. As defined herein, a "microstructure" refers to a structure having at least one dimension (e.g., average width, average diameter, average height, average length, average depth, etc.) that does not exceed about 2 mm, and typically does not exceed about 1 mm. As can be appreciated, when a medical device includes one or more surface structures, 1) all of the surface structures can be microstructures, 2) all of the surface structures can be non-microstructures, or 3) a portion of the surface structures can be microstructures and a portion can be non-microstructures. Typically, a microstructure (when formed) extends from or into an outer surface by no more than about 400 microns (0.01 to 400 microns and all values and ranges therebetween), and more typically less than about 300 microns, and more typically about 15 to 250 microns; however, other dimensions can be used. The microstructures can be clustered together or distributed across the surface of the medical device. Microstructures and / or surface structures of similar shape and / or size can be used or microstructures of different shape and / or size can be used. When one or more surface structures and / or microstructures are designed to extend from a surface of the medical device, the one or more surface structures and / or microstructures can be formed in the extended position and / or designed to extend from the medical device during and / or after the medical device is deployed at a treatment site. The microstructures and / or surface structures can be designed to contain and / or fluidly connect to channels, cavities, etc.; however, this is not required. The one or more surface structures and / or microstructures can be used to engage and / or penetrate surrounding tissue or organs once the medical device has been positioned on and / or in a patient's body; however, this is not required. The one or more surface structures and / or microstructures can be used to facilitate the formation and maintenance of a shape of the medical device. In one non-limiting embodiment, the one or more surface structures and / or microstructures can be formed at least partially from a formulation and / or from a polymer. One or more of the surface structures and / or microstructures can include one or more internal channels that can include one or more materials (e.g., a formulation, a polymer, etc.); however, this is not required. One or more coatings of the medical device and / or one or more surface structures and / or microstructures can be used for a variety of purposes, such as but not limited to: 1) increasing the adhesion and / or cohesion of one or more formulations, adhesives, marker materials, and / or polymers to the medical device, 2) altering the appearance or surface properties of the medical device, and / or 3) controlling the release rate of one or more formulations. The one or more microstructures and / or surface structures can be biostable, biodegradable, etc.A medical device or one or more regions of a medical device can be at least partially covered and / or filled with a protective material to at least partially protect one or more regions of the medical device and / or one or more microstructures and / or surface structures on the medical device from damage. The protective material can include one or more polymers identified previously herein. The protective material can be 1) bio-stable and / or biodegradable and / or 2) porous and / or non-porous.

[0092] According to another and / or alternative non-limiting aspect of the present disclosure, the medical device can optionally be an expandable device, which can be expanded by use of some other device (e.g., a balloon, etc.). The expandable medical device can be manufactured from a material that does not have or substantially does not have shape memory properties.

[0093] According to another and / or alternative non-limiting aspect of the present disclosure, a near-net process for a frame or other metal component of a medical device is optionally provided. In one non-limiting embodiment of the present disclosure, a method of powder compacting a material and increasing strength after sintering by imparting additional cold work is provided. In one non-limiting embodiment, a green part is compacted and then sintered. Thereafter, the sintered part is again compacted to increase its mechanical strength by imparting cold work to the compacted and sintered part. Typically, the temperature during the compacting process after the sintering process is 20°C to 100°C (and all values and ranges therebetween), typically 20°C to 80°C, and more typically 20°C to 40°C. As defined herein, the cold work is performed at a temperature that does not exceed 150°C (e.g., 10°C to 150°C and all values and ranges therebetween). The change in shape of the post-sintered part that is re- compacted needs to be determined so that the final part (compacted, sintered, and re- compacted) meets the dimensional requirements of the final shaped part. For metal alloys, a pre- compaction pressure of 1 tsi (1 ton per square inch) to 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 to 2600°C and all values and ranges therebetween) and a post-sintering compaction at a pressure of 1 tsi to 300 tsi (and all values and ranges therebetween) at a temperature of at least 20°C (e.g., 20°C to 100°C and all values and ranges therebetween; 20°C to 40°C, etc.). A process of increasing the mechanical strength of a compacted metal part by compacting the post-sintered part to add additional cold work to the material to increase its mechanical strength is also provided. A process of using a metal powder to compact the powder into a near-net or final part is also provided. In one non-limiting embodiment, the metal powder used to form the near-net or final part includes one or more of the elements rhenium, molybdenum, titanium, cobalt, iron, boron, nickel, tungsten, tantalum, aluminum, vanadium, chromium, niobium, silicon, manganese, carbon, zirconium, iridium, titanium, bismuth, and yttrium.

[0094] According to another and / or alternative non-limiting aspects of the present disclosure, a press for near-net or finished part composites is optionally provided. Processes for pressing metals into near-finished parts are well established; however, pressing composite structures formed from metal powders and polymers for the purpose of manufacturing complex part geometries and foam-like structures is new. Similarly, the use of pressing processes to impart specific biological substances to a metal matrix is also new. In one non-limiting embodiment, a process is provided for creating a metal part with predefined voids to create a trabecular or foam structure, the process consisting of mixing a metal and a polymer powder, pressing the powder into a finished part or semi-finished parison, 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 prior to 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 effect (e.g., masking the metal from the body by encapsulation, promoting cell attachment and growth). 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. As should be appreciated, the polymer can be dispersed uniformly or non-uniformly with the metal powder. For example, if the final formed part is to have a uniform density and pore structure, the polymer material is uniformly dispersed with the metal powder prior to consolidating and pressing the polymer and metal powder together, followed by sintering with the metal powder to form a metal part or medical device. Alternatively, if the formed metal part or medical device is to have one or more channels, passages, and / or voids on an outer surface of the formed part or medical device and / or within the formed part or medical device, at least a portion of the polymer is not uniformly distributed with the metal powder, but is concentrated or forms all of the area that will become the one or more channels, passages, and / or voids on an outer surface of the formed part or medical device and / or within the formed part or medical device, such that when the polymer and metal powder are sintered, some or all of the polymer is degraded and removed from the part or medical device, thereby forming such one or more channels, passages, and / or voids on an outer surface of the formed part or medical device and / or within the formed part or medical device. Thus, the combined use of a polymer with a metal powder and subsequent pressing and sintering can be used to form novel and customized shapes of a medical device or near-net forms of the medical device.Typically, the polymer prior to the sintering step comprises about 0.1 to 70 volume percent (and all values and ranges therebetween) of the consolidated and pressed material, typically, the polymer prior to the sintering step comprises about 1 to 60 volume percent of the consolidated and pressed material, more typically, the polymer prior to the sintering step comprises about 2 to 50 volume percent of the consolidated and pressed material, and even more typically, the polymer prior to the sintering step comprises about 2 to 45 volume percent of the consolidated and pressed material. Thus, if the polymer prior to the sintering step comprises about 5 volume percent of the consolidated and pressed material, if at least 99 percent of the polymer is degraded and removed from the part or medical device after the sintering step, then up to about 5 volume percent of cavities and / or channels can be included in the part. The type of polymer and the type of metal powder are non-limiting. The polymer and the metal powder can have different sizes to create a plurality of voids / channels / trenches that can be used for one or more of creating pathways for cell growth, creating a wrinkled surface to promote cell attachment, inserting a biological agent into one or more of the voids / channels / trenches, inserting a biomaterial into one or more of the voids / channels / trenches, etc. In one non-limiting embodiment, the average particle size of the polymer is greater than the average particle size of the metal powder.

[0095] According to another and / or alternative non-limiting aspect of the present disclosure, after the sintering process, at least 98 volume percent of the polymer is thermally degraded and / or removed from the sintered material, typically, at least 99 volume percent of the polymer is thermally degraded and / or removed from the sintered material, more typically, at least 99.5 volume percent of the polymer is thermally degraded and / or removed from the sintered material, even more typically, at least 99.9 volume percent of the polymer is thermally degraded and / or removed from the sintered material, and even more typically, at least 99.95 volume percent of the polymer is thermally degraded and / or removed from the sintered material. The resulting part or medical device has a porosity associated with the size of the polymer particles and the homogeneity of the mixture when pressed prior to sintering.

[0096] According to another and / or alternative non-limiting aspect of the present disclosure, after the sintering process, some of the polymer remains in the sintered part of the medical device. The remaining polymer in the sintered part of the medical device can optionally have some desired biological effect (e.g., by encapsulating the metal from the body, promoting cell attachment and growth). The remaining polymer can optionally contain one or more biological agents that remain active after the sintering process. In one non-limiting embodiment, after the sintering process, about 5 to 97.5 volume percent (and all values and ranges therebetween) of the polymer is thermally degraded and / or removed from the sintered material, typically, about 10 to 95 volume percent of the polymer is thermally degraded and removed from the sintered material, and more typically, about 10 to 80 volume percent of the polymer is thermally degraded and removed from the sintered material.

[0097] According to another and / or alternative non-limiting aspect of the present disclosure, the metal alloy used to at least partially form the medical device is initially formed into a billet, rod, tube, etc. and then finished into the final form via one or more finishing processes. The metal alloy billet, rod, tube, etc. can be formed via various techniques such as, but not limited to, 1) melting the metal alloy and / or the metals that form the metal alloy (e.g., vacuum arc melting, etc.) and then extruding and / or casting the metal alloy into a billet, rod, tube, etc., 2) melting the metal alloy or and / or the metals that form the metal alloy to form a metal strip and then rolling and welding the strip into a billet, rod, tube, etc., or 3) consolidating metal powders of the metal alloy and / or the metals that form the metal alloy into a billet, rod, tube, etc. When the metal alloy is formed into a billet, the shape and size of the billet is non-limiting. In one non-limiting process, the near-net medical device, billet, rod, tube, etc. can be formed from one or more ingots of the metal or metal alloy. In one non-limiting process, an arc melting method (e.g., vacuum arc melting method, etc.) can be used to form the near-net medical device, billet, rod, tube, etc. In another non-limiting process, rhenium powder, tungsten powder, and optionally molybdenum powder can be placed in a crucible (e.g., quartz crucible, etc.) and heated via an induction melting furnace under a controlled atmosphere (e.g., vacuum environment, carbon monoxide environment, hydrogen and argon environment, helium, argon, etc.) to form the near-net medical device, billet, rod, tube, etc. It can be appreciated that other or additional processes can be used to form the metal alloy. In one non-limiting embodiment, the average particle size of the metal powders 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 powders is about 2 to 63 microns, and more particularly about 5 to 40 microns. As should be appreciated, smaller average particle sizes can be used. The purity of the metal powders should be selected such that the metal powders contain very low carbon, oxygen, and nitrogen content. Typically, the carbon content of the metal powders used to form the metal alloy is less than about 100 ppm, the oxygen content is less than about 50 ppm, and the nitrogen content is less than about 20 ppm. Typically, the metal powders used to form the metal alloy have a purity rating 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 metal alloy into the near-net medical device, billet, rod, tube, etc. Typically, the pressing process employs an isostatic pressing process (i.e., pressure applied uniformly on the metal powders from all sides); however, other processes can be used. When the metal powders are pressed together isostatically, cold isostatic pressing (CIP) is typically used to consolidate the metal powders; however, this is not required. The pressing process can 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, billet, rod, tube, etc. achieved by pressing the metal powders together is about 80 to 95% (and all values and ranges therebetween) of the final average density of the near-net medical device, billet, rod, tube, etc., or 70 to 96% (and all values or ranges therebetween) of the minimum theoretical density of the metal alloy. Pressing pressures of at least 300 MPa are typically used. Typically, the pressing pressure is about 400-700 MPa; however, other pressures can 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 to 3500 °C and all values and ranges therebetween) to partially or completely fuse the metal powders together to form the near-net medical device, billet, rod, tube, etc. The sintering of the consolidated metal powders can be performed in an oxygen reducing atmosphere (e.g., helium, argon, hydrogen, argon and hydrogen mixtures, etc.) and / or under vacuum; however, this is not required. At high sintering temperatures, a high hydrogen atmosphere will reduce the amount of carbon and oxygen near the formed net medical device, billet, rod, tube, etc. The average post-sintered density of the sintered metal powders is typically about 90 to 99% of the minimum theoretical density of the metal alloy. Typically, the sintered metal alloy has a final average density of at least about 5 gm / cc and typically at least about 8.3 gm / cc, and can be up to or greater than about 16 gm / cc; however, this is not required. The density near the formed near-net medical device, billet, rod, tube, etc. will typically depend on the type of metal alloy used.

[0098] According to another and / or alternative non-limiting aspect of the present disclosure, after the near-net medical device, billet, rod, tube, etc. has been formed, the near-net medical device, billet, rod, tube, etc. can optionally be cleaned and / or polished; however, this is not required. Typically, the near-net medical device, billet, rod, tube, etc. is cleaned and / or polished prior to further processing; however, this is not required. The near-net medical device, billet, rod, tube, etc. is resized and / or annealed, typically the resized and / or annealed near-net medical device, billet, rod, tube, etc. is cleaned and / or polished prior to and / or after the series of resizing and / or annealing processes; however, this is not required. The cleaning and / or polishing of the near-net medical device, billet, rod, tube, etc. serves to remove impurities and / or contaminants from the surface of the near-net medical device, billet, rod, tube, etc. During the processing of the near-net medical device, billet, rod, tube, etc., impurities and contaminants can become incorporated into the metal alloy. The inadvertent incorporation of impurities and contaminants into the near-net medical device, billet, rod, tube, etc. can result in an undesirable amount of carbon, nitrogen, and / or oxygen and / or other impurities in the metal alloy. The inclusion of impurities and contaminants in the metal alloy can result in premature micro-cracking of the metal alloy and / or adversely affect one or more physical properties of the metal alloy (e.g., reduced tensile elongation, increased ductility, increased brittleness, etc.). The cleaning of the metal alloy can be accomplished by a variety of techniques such as, but not limited to, 1) using a solvent (e.g., acetone, methanol, etc.) and wiping the metal alloy with a Kimwipe or other suitable rag, 2) at least partially immersing or submerging the metal alloy in a solvent followed by ultrasonic cleaning of the metal alloy, and / or 3) at least partially immersing or submerging the metal alloy in a pickling solution. As should be appreciated, the metal alloy can be cleaned by other or additional means. If the metal alloy is to be polished, typically the metal alloy is polished by using a polishing solution that typically includes an acid solution; however, this is not required.

[0099] According to another and / or alternative non-limiting aspect of the present disclosure, the near-net medical device, billet, rod, tube, etc. can be resized to the desired dimensions of the medical device. In one non-limiting embodiment, the cross-sectional area or diameter of the near-net medical device, billet, rod, tube, etc. is reduced to the final near-net medical device, billet, rod, tube, etc. dimensions in a single step or by a series of steps. The reduction in the outer cross-sectional area or outer diameter of the near-net medical device, billet, rod, 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 size of the near-net medical device, billet, rod, 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 micro-cracks in the near-net medical device, billet, rod, tube, etc. during the reduction in the outer cross-sectional area or outer diameter of the near-net medical device, billet, rod, tube, etc.

[0100] It is a non-limiting object of the present disclosure to provide a metal alloy according to the present disclosure that can be used to partially or entirely form a medical device.

[0101] It is another and / or alternative non-limiting object of the present disclosure to provide a medical device that is partially or entirely formed from a metal alloy of the present disclosure that has an improved surgical success rate.

[0102] It is another and / or alternative non-limiting object of the present disclosure to provide a method and process for forming a metal alloy according to the present disclosure that inhibits or prevents the formation of micro-cracks during the processing of the metal alloy.

[0103] It is another and / or alternative non-limiting object of the present disclosure to provide a medical device that is partially or entirely formed from a metal alloy according to the present disclosure, wherein the medical device has improved physical properties.

[0104] It is another and / or alternative non-limiting object of the present disclosure to provide a medical device that is at least partially formed from a metal alloy according to the present disclosure, wherein the medical device has increased strength and / or hardness.

[0105] It is another and / or alternative non-limiting object of the present disclosure to provide a medical device that at least partially contains a metal alloy according to the present disclosure that is capable of forming the medical device with less material compared to existing medical devices without sacrificing the strength of the medical device.

[0106] It is another and / or alternative non-limiting object of the present disclosure to provide a method and process for forming a metal alloy according to the present disclosure that inhibits or prevents the formation of micro-cracks during the processing of the metal alloy into a medical device.

[0107] It is another and / or alternative non-limiting object of the present disclosure to provide a method and process for forming a metal alloy according to the present disclosure that inhibits or prevents crack propagation and / or fatigue failure of the metal alloy.

[0108] It is another and / or alternative non-limiting object of the present disclosure to provide a medical device that has been subjected to a nitriding process to form a nitrided layer on an outer surface of the metal alloy.

[0109] It is another and / or alternative non-limiting object of the present disclosure to provide a medical device wherein the metal alloy has been subjected to a swaging process.

[0110] It is another and / or alternative non-limiting object of the present disclosure to provide a medical device that contains a metal alloy wherein the metal alloy has been subjected to a cold working process.

[0111] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device comprising a metal alloy having increased strength and / or hardness compared to standard stainless steel, standard chromium-cobalt alloys, or standard titanium alloys.

[0112] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device comprising a metal alloy such that a lesser amount of the metal alloy is needed to achieve similar strength compared to medical devices formed from different metals.

[0113] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device comprising a metal alloy, wherein the medical device has a smaller crimp profile compared to medical devices formed from different metals.

[0114] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device comprising a metal alloy, wherein the medical device has a thinner wall and still achieves similar or improved radial strength compared to thicker walled medical devices formed from standard stainless steel, standard chromium-cobalt alloys, or standard titanium alloys.

[0115] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device comprising a metal alloy, wherein the medical device has improved stress-strain properties, bending properties, elongation properties, and / or flexibility properties compared to medical devices formed from standard stainless steel, standard titanium steel, or standard chromium-cobalt alloys.

[0116] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device comprising a metal alloy, wherein the medical device has increased longevity compared to medical devices formed from standard stainless steel, standard titanium steel, or standard chromium-cobalt alloys.

[0117] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device comprising a metal alloy, wherein the medical device has a reduced degree of recoil during crimping and / or expansion of the medical device compared to standard stainless steel, standard chromium-cobalt alloys, or standard titanium alloys.

[0118] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device comprising a metal alloy, wherein the medical device better conforms to irregularly shaped body passageways when expanded in the body passageways compared to medical devices formed from standard stainless steel, standard chromium-cobalt alloys, or standard titanium alloys.

[0119] Another and / or alternative non-limiting object of the present disclosure is to provide a medical device comprising a metal alloy, wherein the medical device has improved fatigue ductility when subjected to cold working compared to cold working of standard stainless steel, standard chromium-cobalt alloys, or standard titanium alloys.

[0120] It is another and / or alternative non-limiting object of the present disclosure to provide a medical device comprising a metal alloy, wherein the medical device has improved durability compared to standard stainless steel, standard chromium-cobalt alloy, or standard titanium alloy.

[0121] It is another and / or alternative non-limiting object of the present disclosure to provide a medical device comprising a metal alloy, wherein the medical device has improved hydrophilicity compared to standard stainless steel, standard chromium-cobalt alloy, or standard titanium alloy.

[0122] It is another and / or alternative non-limiting object of the present disclosure to provide a medical device comprising a metal alloy, wherein the medical device has reduced ion release in a body passage compared to standard stainless steel, standard chromium-cobalt alloy, or standard titanium alloy.

[0123] It is another and / or alternative non-limiting object of the present disclosure to provide a medical device comprising a metal alloy, wherein the medical device has less irritation to the body compared to standard stainless steel or standard cobalt-chromium alloy, or standard titanium alloy, and thus can result in reduced inflammation, faster healing, and improved success rate of the medical device.

[0124] According to another and / or alternative non-limiting aspect of the present disclosure, the medical device can be formed at least partially or entirely by 3D printing.

[0125] According to another and / or alternative non-limiting aspects of the present disclosure, the unique combination of metals in the metal alloys of the present disclosure having the required purity and composition and the required grain size results in: 1) the medical device having the required high ductility at about room temperature, 2) the medical device having the required amount of tensile elongation, 3) the homogeneous solution or solid solution of the metal alloy having high radiopacity, 4) reduction or prevention of micro-crack formation and / or fracture of the metal alloy tube of the present disclosure when the tube is sized and / or cut to form the medical device or a portion of the medical device (e.g., a frame of the medical device, etc.), 5) reduction or prevention of micro-crack formation and / or fracture of the medical device or a portion of the medical device (e.g., a frame of the medical device, etc.) when the medical device or a portion of the medical device (e.g., a frame of the medical device, etc.) is crimped, 6) reduction or prevention of micro-crack formation and / or fracture of the medical device or a portion of the medical device (e.g., a frame of the medical device, etc.) when the medical device is bent and / or expanded in the body passageway; 7) the medical device having the required ultimate tensile strength and yield strength; 8) the medical device or a portion of the medical device (e.g., a frame of the medical device, etc.) having a very thin wall thickness and still having the required radial force needed to keep the medical device or a portion of the medical device (e.g., a frame of the medical device, etc.) in an open state when expanded; 9) the medical device or a portion of the medical device (e.g., a frame of the medical device, etc.) exhibiting less recoil when the medical device or a portion of the medical device (e.g., a frame of the medical device, etc.) is crimped onto a delivery system and / or expanded in the body passageway; 10) the medical device exhibiting improved conformance to the shape of the treatment area in the body passageway when the medical device is expanded in the body passageway; 11) the medical device exhibiting improved fatigue ductility; 12) the medical device exhibiting reduced foreshortening when expanded; and / or 13) the medical device exhibiting improved durability.

[0126] These and other advantages will become apparent to those skilled in the art upon reading and understanding this specification.

[0127] While specific terminology is employed in the following description for the sake of clarity, the use of such terminology is only in the sense of illustrative embodiments selected for describing the disclosure and is not intended to be limiting or restrictive of the disclosure. In the drawings and the following description, it is understood that like reference numerals refer to components having the same function in the various embodiments.

[0128] The singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.

[0129] As used in the specification and claims, the term "comprising" can include the embodiments "consisting of and "consisting essentially of." The terms "comprise(s)," "contain(s)," "have(s)," "include(s)," "can," "contain(s)," "hold(s)," "involve(s)," and "may" and their variations, as used herein, are intended to be open-ended transitional phrases, terms, or words that ensure the transi tional phrase, term, or word that follows the term is present and permits the inclusion of additional unstated elements or sti p s. However, such description should not be interpreted as a limitation on the composition or process described and the exclusivity of the elements or steps presented by the claim.

[0130] Numerical values in the specification and claims of this application should be understood to include numerical values which are the same when reduced to the same number of significant figures and numerical values which differ by less than the experimental error of conventional measurement techniques used in the art to determine the value.

[0131] All ranges disclosed herein are inclusive of the endpoints and the intermediate values. For example, a range of "2 grams to 10 grams" includes 2 grams and 10 grams, as well as all intermediate values, e.g., 3, 4, 5, 6, 7, 8, and 9 grams.

[0132] The terms "about" and "approximately" can be used to include 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, e.g., "about 2 to about 4" also discloses the range of "2 to 4." In general, the terms "about" and "approximately" can refer to plus or minus 10% of the indicated number.

[0133] Unless otherwise stated, percentages of elements should be assumed to be percentages by weight of the stated element.

[0134] Although the operations of the example embodiments of the disclosed methods can be described in a particular, sequential order, it should be understood that the disclosed embodiments can include operations in other orders than those described. For example, operations described sequentially can in some cases be rearranged or performed concurrently. Moreover, the description and disclosure provided in association with one particular embodiment are not limited to that embodiment, and can be applied to any of the disclosed embodiments.

[0135] For simplicity, the attached figures can not show the various ways in which the systems, methods, and devices disclosed therein can be combined with other systems, methods, and devices (as would be readily recognized by one of skill in the art based on the disclosure). Additionally, the description sometimes uses terms like "produce" and "provide" to describe the disclosed methods. Such terms are high-level abstractions of the actual operations that can be performed by the specific embodiments. The actual operations that correspond to these terms can vary depending on the particular implementation and are readily recognizable by one of ordinary skill in the art based on the disclosure.

[0136] Therefore, it will be found that the above-stated objects, as well as those which become apparent from the foregoing description, are effectively obtained and those purposes which become clear from the foregoing description are achieved, and since certain changes can be made in the constructions set forth without departing from the spirit and scope of the disclosure, it is intended that all matter contained in the above description shall be interpreted as illustrative and not in a limiting sense. The disclosure has been described with reference to preferred and alternative embodiments. Modifications and alterations will become apparent to others upon reading and understanding the detailed discussion of the disclosure provided herein. It is intended that the disclosure contained herein be construed as including all such modifications and alterations insofar as they come within the scope of the disclosure. It should also be understood that all generic and specific features described herein and all statements of the scope of the disclosure made herein are intended to encompass both structural and functional equivalents. Furthermore, it is intended that the scope of the disclosure encompass all competing and equivalent claims to the extent permitted by law.

[0137] To help the Patent Office and readers of the application and any patent issuing thereon to understand the scope and content of the disclosure, the applicant does not intend any appended claims or claim elements to invoke 35 U.S.C. 112(f) unless the words "means for" or "step for" are specifically used in the particular claim.

Claims

1. A medical device formed, in part or in whole, of a metal alloy; said metal alloy comprising: a) stainless steel containing at least 15 atomic weight % rhenium, b) a cobalt-chromium alloy containing at least 15 atomic weight % rhenium, c) a TiNi alloy containing at least 15 atomic weight % rhenium, d) a TiAlV alloy containing at least 15 atomic weight % rhenium, e) an Al alloy containing at least 15 atomic weight % rhenium, f) a Ni alloy containing at least 15 atomic weight % rhenium, g) a Ti alloy containing at least 15 atomic weight % rhenium, h) a W alloy containing at least 15 atomic weight % rhenium, i) a metal alloy containing at least 15 atomic weight % rhenium, and so on. Cu alloys containing at least 15 atomic weight percent rhenium; j) beryllium-copper alloys containing at least 15 atomic weight percent rhenium; k) at least 30 weight percent of one or more of niobium, tantalum, titanium, cobalt, chromium, zirconium, or tungsten; and further containing at least 15 atomic weight percent rhenium; l) at least 50 weight percent of one or more of niobium, tantalum, titanium, cobalt, chromium, zirconium, or tungsten; and further containing 1-40 weight percent 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 oxides. One or more of zirconium; and further comprising at least 15 atomic weight percent rhenium, m) at least 60 atomic weight percent tungsten, at least 15 atomic weight percent rhenium, n) at least 60 atomic weight percent tungsten, at least 15 atomic weight percent rhenium and at least 1 atomic weight percent molybdenum, o) at least 50 atomic weight percent rhenium, at least 20 atomic weight percent chromium and 0.1-80 atomic weight percent 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, 15-45 wt% niobium, 1-10 wt% zirconium and 1-15 wt% tantalum, q) greater than 50 wt% titanium, 15-45 wt% niobium and 1-10 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.

2. The medical device of claim 1, wherein the metal alloy comprises 51-80 wt% titanium, 15-45 wt% niobium, 1-10 wt% zirconium and 1-15 wt% tantalum.

3. The medical device of claim 1, wherein the metal alloy comprises 58-70 wt% titanium, 27-37 wt% niobium, 2-9 wt% zirconium, and 1-15 wt% tantalum.

4. The medical device of claim 1, wherein the metal alloy comprises 51-80 wt% titanium, 15-45 wt% niobium, and 1-10 wt%.

5. The medical device of claim 1, wherein the metal alloy comprises 58-69 wt% titanium, 27-33 wt% niobium, and 4-8 wt% molybdenum.

6. The medical device of claim 1, wherein the metal alloy comprises 30-60 wt% cobalt, 10-30 wt% chromium, 5-20 wt% iron, 5-22 wt% nickel, and 2-12 wt% molybdenum.

7. The medical device of claim 1, wherein the metal alloy comprises 35-45 wt% cobalt, 15-25 wt% chromium, 12-20 wt% iron, 10-20 wt% nickel, and 5-9 wt% molybdenum.

8. The medical device of claim 1, wherein the metal alloy comprises 40-60 wt% zirconium and 40-60 wt% molybdenum.

9. The medical device of claim 1, wherein the metal alloy comprises 45-55 wt% cobalt and 45-55 wt% molybdenum.

10. The medical device of claim 1, wherein the metal alloy comprises 90-99.5 wt% niobium and 0.5-10 wt% zirconium.

11. The medical device of claim 1, wherein the metal alloy comprises 95-99.25 wt% niobium and 0.75-4 wt% niobium.

12. The medical device of claim 1, wherein the metal alloy comprises 55-75 wt% niobium, 18-40 wt% tantalum, 1-7 wt% tungsten, and 0.5-4 wt% zirconium.

13. The medical device of claim 1, wherein the metal alloy comprises 60-70 wt% niobium, 24-32 wt% tantalum, 2-5 wt% tungsten, and 0.75-3 wt% zirconium.

14. The medical device of claim 1, wherein the metal alloy comprises 10-60 atomic weight percent (atomic wt%) Re and one or more metals selected from the group consisting of Mo, Cr, Ta, Nb, Ti, and Zr.

15. The medical device of claim 1, wherein the metal alloy comprises 0.5-50 atomic wt% Re and 0.5-70 atomic wt% Cr.

16. The medical device of claim 1, wherein the metal alloy comprises 0.5-50 atomic wt% Re and 0.5-70 atomic wt% Ta.

17. The medical device of claim 1, wherein the metal alloy comprises 0.5-50 atomic wt% Re and 0.5-70 atomic wt% Nb.

18. The medical device of claim 1, wherein the metal alloy comprises 0.5-50 atomic wt% Re and 0.5-70 atomic wt% Ti.

19. The medical device of claim 1, wherein the metal alloy comprises 50-75 atomic wt% Re, 24-49 wt% Cr, and 1-15 wt% Mo.

20. The medical device of claim 1, wherein the medical device comprises a) a medical device for implantation in a body passageway, b) a medical device for implantation in the spinal column, c) a medical device for implantation in bone.

21. The medical device of any one of claims 2-19, wherein the medical device comprises a) a medical device for implantation in a body passageway, b) a medical device for implantation in the spinal column, c) a medical device for implantation in bone.

22. The medical device of claim 20, wherein the medical device comprises an expandable frame formed at least partially from the metal alloy.

23. The medical device of claim 21, wherein the medical device comprises an expandable frame formed at least partially from the metal alloy.

24. The medical device of claim 1, wherein at least one region of the medical device comprises at least one biologic agent.

25. The medical device of any one of claims 2-23, wherein at least one region of the medical device comprises at least one biologic agent.

26. The medical device of claim 1, wherein at least one region of the medical device comprises at least one polymer.

27. The medical device of any one of claims 2-25, wherein at least one region of the medical device comprises at least one polymer.

28. The medical device of claim 1, further comprising at least one microstructure on an outer surface of the medical device.

29. The medical device of any one of claims 2-27, further comprising at least one microstructure on an outer surface of the medical device.

30. A metal alloy comprising: a) stainless steel comprising at least 15 atomic wt. % rhenium, b) cobalt-chromium alloy comprising at least 15 atomic wt. % rhenium, c) TiNi alloy comprising at least 15 atomic wt. % rhenium, d) TiAlV alloy comprising at least 15 atomic wt. % rhenium, e) Al alloy comprising at least 15 atomic wt. % rhenium, f) Ni alloy comprising at least 15 atomic wt. % rhenium, g) Ti alloy comprising at least 15 atomic wt. % rhenium, h) W alloy comprising at least 15 atomic wt. % rhenium, i) Cu alloy comprising at least 15 atomic wt. % rhenium, j) beryllium-copper alloy comprising at least 15 atomic wt. % rhenium, k) at least 30 wt. % of one or more of niobium, tantalum, titanium, cobalt, chromium, zirconium, or tungsten; and further comprising at least 15 atomic wt. % rhenium, 1) at least 50 wt. % of one or more of niobium, tantalum, titanium, cobalt, chromium, zirconium, or tungsten, and further comprising 1-40 wt. % of one or more of aluminum, bismuth, calcium, carbon, cerium oxide, copper, gold, hafnium, iridium, iron, lanthanum, lanthanum oxide, lead, magnesium, manganese, nickel, osmium, platinum, rare earth metals, rhodium, ruthenium, silicon, silver, technetium, tin, titanium, tungsten, vanadium, yttrium, yttrium oxide, zinc, and zirconium oxide; and further comprising at least 15 atomic wt. % rhenium, m) at least 60 wt. % tungsten, at least 15 atomic wt. % rhenium, n) at least 60 wt. % tungsten, at least 15 atomic wt. % rhenium, and at least 1 wt. % molybdenum, o) at least 50 wt. % rhenium, at least 20 wt. % chromium, and 0.1-80 wt. % of one or more of aluminum, bismuth, calcium, carbon, cerium oxide, chromium, cobalt, copper, gold, hafnium, iridium, iron, lanthanum, lanthanum oxide, lead, magnesium, manganese, molybdenum, nickel, niobium, osmium, platinum, rare earth metals, rhodium, ruthenium, silicon, silver, tantalum, technetium, tin, titanium, tungsten, vanadium, yttrium, yttrium oxide, zinc, zirconium, and zirconium oxide, p) greater than 50 wt. % titanium, 15-45 wt. % niobium, 1-10 wt. % zirconium, and 1-15 wt. % tantalum, q) greater than 50 wt. % titanium, 15-45 wt. % niobium, and 1-10 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.

31. The metal alloy of claim 30, wherein the metal alloy comprises 51-80 wt. % titanium, 15-45 wt. % niobium, 1-10 wt. % zirconium, and 1-15 wt. % tantalum.

32. The metal alloy of claim 30, wherein the metal alloy comprises 58-70 wt. % titanium, 27-37 wt. % niobium, 2-9 wt. % zirconium, and 1-15 wt. % tantalum.

33. The metal alloy of claim 30, wherein the metal alloy comprises 51-80 wt. % titanium, 15-45 wt. % niobium, and 1-10 wt. %.

34. The metal alloy of claim 30, wherein the metal alloy comprises 58-69 wt. % titanium, 27-33 wt. % niobium, and 4-8 wt. % molybdenum.

35. The metal alloy of claim 30, wherein the metal alloy comprises 30-60 wt. % cobalt, 10-30 wt. % chromium, 5-20 wt. % iron, 5-22 wt. % nickel, and 2-12 wt. % molybdenum.

36. The metal alloy of claim 30, wherein the metal alloy comprises 35-45 wt. % cobalt, 15-25 wt. % chromium, 12-20 wt. % iron, 10-20 wt. % nickel, and 5-9 wt. % molybdenum.

37. The metal alloy of claim 30, wherein the metal alloy comprises 40-60 wt. % zirconium and 40-60 wt. % molybdenum.

38. The metal alloy of claim 30, wherein the metal alloy comprises 45-55 wt. % cobalt and 45-55 wt. % molybdenum.

39. The metal alloy of claim 30, wherein the metal alloy comprises 90-99.5 wt. % niobium and 0.5-10 wt. % zirconium.

40. The metal alloy of claim 30, wherein the metal alloy comprises 95-99.25 wt. % niobium and 0.75-4 wt. % zirconium.

41. The metal alloy of claim 30, wherein the metal alloy comprises 55-75 wt. % niobium, 18-40 wt. % tantalum, 1-7 wt. % tungsten, and 0.5-4 wt. % zirconium.

42. The metal alloy of claim 30, wherein the metal alloy comprises 60-70 wt. % niobium, 24-32 wt. % tantalum, 2-5 wt. % tungsten, and 0.75-3 wt. % zirconium.

43. The metal alloy of claim 30, wherein the metal alloy comprises 10-60 atomic weight percent (atomic wt. %) Re and one or more metals selected from the group consisting of Mo, Cr, Ta, Nb, Ti, and Zr.

44. The metal alloy of claim 30, wherein the metal alloy comprises 0.5-50 atomic wt. % Re and 0.5-70 atomic wt. % Cr.

45. The metal alloy of claim 30, wherein the metal alloy comprises 0.5-50 atomic wt. % Re and 0.5-70 atomic wt. % Ta.

46. The metal alloy of claim 30, wherein the metal alloy comprises 0.5-50 atomic wt. % Re and 0.5-70 atomic wt. % Nb.

47. The metal alloy of claim 30, wherein the metal alloy comprises 0.5-50 atomic wt. % Re and 0.5-70 atomic wt. % Ti.

48. The metal alloy of claim 30, wherein the metal alloy comprises 50-75 atomic wt. % Re, 24-49 wt. % Cr, and 1-15 wt. % Mo.

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