Expandable system for repairing bone fractures

Abstract

A system for percutaneous fixation and stabilization of a fracture site using a spanning expandable structural frame for placement in an intramedullary cavity of a bone includes an expandable medical device.

Description

[0001] CITED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Application Serial No. 63 / 536,948, filed September 7, 2023, which is incorporated by reference herein. TECHNICAL FIELD

[0003] The present disclosure relates generally to the fixation, repair, and stabilization of bone fractures, specifically to an expandable medical device that can be partially or completely inserted into a fractured bone to facilitate the fixation, repair, and stabilization of the fractured bone, more specifically to an expandable medical device that is partially or completely formed from a metal alloy containing rhenium that can be partially or completely inserted into a fractured bone to facilitate the fixation, repair, and stabilization of the fractured bone, and even more specifically to an expandable medical device that is partially or completely formed from a metal alloy containing rhenium that can be partially or completely inserted into a fractured bone to facilitate the fixation, repair, and stabilization of the fractured bone, and wherein the metal alloy used to partially or completely form the expandable medical device has a sufficient amount of rhenium such that the ductility and tensile strength of the metal alloy are improved. BACKGROUND

[0004] Common methods of treating bone fractures include reducing the fracture site and limiting motion in the fractured area via a cast or a bandage. Often, pins, screws, rods, and cement are used to repair the fractured bone. In some of these fracture treatments, the fractured bone is not properly stabilized, resulting in potential misalignment of the fractured bone. Figures 1 to 3 Common systems and methods for fixing a fracture site are demonstrated, including external fixation of the fracture site with a cast, a splint device, or an external fixation frame (see Figure 1 ), internal fixation with plates and screws (see Figure 2 ), or indirect fixation of the fracture site by insertion of an intramedullary device (see Figure 3 ).

[0005] As described and demonstrated in Figures 1 to 3 , these prior art bone fixation devices have several drawbacks. For example, as demonstrated in Figure 1 , casted devices can result in a) long-term immobilization of the fracture area, increasing patient discomfort and inconvenience during healing of the fractured bone, b) potential muscle atrophy due to long-term immobilization, requiring an extended recovery period and potential physical therapy, c) potential increased incidence of thrombosis, and d) potential development of disuse syndrome.

[0006] Currently, some bone fixation devices use a compression plate and screw device to apply a compressive force at the fracture site (see Figure 2). Such fixation devices sometimes require large surgical incisions over the bone at the fracture site. Installation of plates and screws often a) requires disturbance of soft tissue over the fracture site, b) causes disturbance to the fracture hematoma, c) is a highly invasive procedure, d) can result in a risk of vascular compromise, e) can require the use of extracortical fixation for later removal of the fixation device, and / or f) can result in periosteal stripping, which can compromise the blood supply to the fractured bone fragments.

[0007] As Figure 3 demonstrated, another system for treating a fracture site includes intramedullary nail fixation. In such procedures, one or more nails are inserted into the intramedullary canal of the fractured bone, typically through an incision at either end of the bone. Intramedullary nail fixation can be superior to external casting and other fracture stabilization methods. However, intramedullary nail fixation has several drawbacks associated with it, namely a) the procedure is highly invasive, b) requires a large incision in the bone (e.g., about 15 mm), c) can result in cortical enlargement, d) results in substantial or complete displacement of bone marrow, e) can result in a risk of pulmonary embolism, f) enlargement of the intramedullary canal and placement of the nail without enlargement can compromise the intramedullary blood supply to the fracture site, g) the shape of the nail can not conform to the shape of the intramedullary canal, resulting in improper or difficult placement of the nail in the intramedullary canal, and / or h) can result in migration of the fixation during fracture repair, resulting in slower recovery time and improper fracture repair. Several prior art intramedullary nails are demonstrated in US 6,783,530; US 6,551,321; US 6,224,600; US 2009 / 0018542; US 2008 / 0255560; and US 2002 / 0032444, all of which are incorporated herein by reference.

[0008] In view of the current state of the art, there is a need in the art for a less invasive and more effective method of stabilizing a fracture site that minimizes disturbance to the fracture biology, minimizes trauma to the intramedullary canal, has better biomechanical properties, and employs a smaller incision. SUMMARY

[0009] The present disclosure relates generally to the fixation, repair and stabilization of bone fractures, specifically to an expandable medical device that can be partially or completely inserted into a fractured bone to facilitate the fixation, repair and stabilization of the fractured bone, more specifically to an expandable medical device that is partially or completely formed from a metal alloy containing rhenium that can be partially or completely inserted into a fractured bone to facilitate the fixation, repair and stabilization of the fractured bone, and even more specifically to an expandable medical device that is partially or completely formed from a metal alloy containing rhenium that can be partially or completely inserted into a fractured bone to facilitate the fixation, repair and stabilization of the fractured bone, and wherein the metal alloy used to partially or completely form the expandable medical device has a sufficient amount of rhenium such that the ductility and tensile strength of the metal alloy is improved. In one non-limiting embodiment, the expandable medical device is generally configured to be partially or completely inserted into the medullary cavity of a fractured bone, having a length sufficient to span the fracture site and capable of expanding within the medullary cavity to conform to the inner surface of the medullary cavity. In another non-limiting embodiment, a guide wire is optionally provided for use with the expandable medical device. The guide wire can be used to facilitate the insertion of the expandable medical device into the medullary cavity of a fractured bone. The guide wire should be sized and shaped for insertion into the medullary cavity, having a length sufficient to span the fracture site while possessing sufficient flexibility and support to guide the expandable medical device partially or completely through the medullary cavity of the fractured bone. In another non-limiting embodiment, a sheath is optionally provided for use with the expandable medical device. The sheath can be used to facilitate the insertion of the expandable medical device into the medullary cavity of a fractured bone. The sheath should be sized and shaped for insertion into the medullary cavity, having a length sufficient to span the fracture site of the fractured bone and / or having an elongated longitudinal cavity sized and shaped to partially or completely receive the expandable medical device therethrough. In another non-limiting embodiment, a hardenable surgical fluid can optionally be used with the expandable medical device. When used with the expandable medical device, the hardenable surgical fluid provides additional support across the fracture site when used.

[0010] In another and / or alternative non-limiting aspect of the present disclosure, the expandable medical device is optionally partially or entirely formed from a) refractory metal alloys and / or b) metal alloys comprising at least 15 atomic weight percent (atomic wt. %) or atomic percent (atomic wt. %) rhenium in order to produce a "rhenium effect" in the metal alloy. As used herein, atomic weight percent (atomic wt. %) or atomic percent (atomic wt. %) are used interchangeably. As defined herein, the weight percent (wt. %) of an element is the weight of that element in a sample divided by the weight of all elements in the sample multiplied by 100. The atomic percent or atomic weight percent (atomic wt. %) is the number of atoms of that element at that weight percent divided by the total number of atoms in the sample multiplied by 100. The use of the terms weight percent (wt. %) and atomic percent or atomic weight percent (atomic wt. %) refer to two ways of referring to the metal alloy and its constituents. It has been discovered that for several metal alloys, the inclusion of at least 15 atomic wt. % rhenium results in an increase in ductility and / or tensile strength of the several metal alloys as compared to the metal alloy without rhenium. The increase in ductility and / or tensile strength due to the inclusion of at least 15 atomic wt. % rhenium in the metal alloy is referred to as the "rhenium effect." As defined herein, the "rhenium effect" is a) at least a 10% increase in ductility of the metal alloy due to the addition of rhenium to the metal alloy and / or b) at least a 10% increase in tensile strength of the metal alloy due to the addition of rhenium to the metal alloy. 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, etc. In one non-limiting arrangement, 50 to 100 wt. % (and all values and ranges therebetween) of the expandable medical device is formed from a refractory metal alloy or a metal alloy comprising at least 15 atomic wt. % rhenium. In another non-limiting arrangement, the metal alloy used to partially or entirely form the expandable medical device comprises at least 30 wt. % (e.g., 30 to 99 wt. % and all values and ranges therebetween) of one or more of molybdenum, rhenium, niobium, tantalum, or tungsten.In another non-limiting embodiment, refractory metal alloys or metal alloys containing at least 15 atomic weight percent rhenium can be used to 1) increase the radiation impermeability of expandable medical devices, 2) increase the radial strength of expandable medical devices, 3) increase the yield strength and / or ultimate tensile strength of expandable medical devices, 4) improve the stress-strain characteristics of expandable medical devices, 5) improve the curling and / or expansion properties of expandable medical devices, 6) improve the bending and / or flexibility of expandable medical devices, 7) improve the strength and / or durability of expandable medical devices, 8) increase the hardness of expandable medical devices, 9) improve the biocompatibility and / or biostability of expandable medical devices, 10) increase the fatigue resistance of expandable medical devices, 11) resist cracking in expandable medical devices, 12) resist crack propagation in expandable medical devices, and 13) enable the manufacture of smaller, thinner, and / or lighter devices. The expandable medical device (BMD) has the following advantages: 14) It helps to reduce the outer diameter of the coiled expandable medical device; 15) It improves the conformability of the expandable medical device to the shape of the treatment area when it expands in the treatment area; 16) It reduces the rebound of the expandable medical device after it expands in the treatment area; 17) It reduces adverse tissue reactions caused by the expandable medical device; 18) It reduces the release of metal ions from the expandable medical device after implantation; 19) It reduces corrosion of the expandable medical device after implantation; 20) It reduces allergic reactions to the expandable medical device after implantation (e.g., by reducing the nickel content of the metal alloy); 21) It increases the hydrophilicity of the expandable medical device; 22) It reduces the magnetization of the expandable medical device; and / or 23) It reduces the toxicity of the expandable medical device after implantation.

[0011] In another and / or alternative non-limiting aspect of this disclosure, the expandable medical device is optionally formed, in part or entirely, of standard stainless steel, standard CoCr alloy, standard TiAlV alloy, standard aluminum alloy, standard nickel alloy, standard titanium alloy, standard tungsten alloy, standard molybdenum alloy, standard copper alloy, standard MP35N alloy, or standard beryllium-copper alloy, which have been modified to contain at least 15 atomic weight percent rhenium, thereby improving ductility and / or tensile strength compared to the same metal alloy without rhenium. As defined herein, a standard stainless steel alloy (SS alloy) comprises 10 to 28 wt% chromium, 0 to 35 wt% nickel, 0 to 4 wt% molybdenum, 0 to 2 wt% manganese, 0 to 0.75 wt% silicon, 0 to 0.3 wt% carbon, 0 to 5 wt% titanium, 0 to 10 wt% niobium, 0 to 5 wt% copper, 0 to 4 wt% aluminum, 0 to 10 wt% tantalum, 0 to 1 wt% selenium, 0 to 2 wt% vanadium, 0 to 2 wt% tungsten, and at least 50 wt% iron. The standard 316L alloy, which is a standard stainless steel alloy, comprises 17 to 19 wt% chromium, 13 to 15 wt% nickel, 2 to 4 wt% molybdenum, up to 2 wt% manganese, up to 0.75 wt% silicon, up to 0.03 wt% carbon, and the balance iron. As defined herein, a standard cobalt-chromium alloy (CoCr alloy) comprises 15 to 32 wt% chromium, 1 to 38 wt% nickel, 2 to 18 wt% molybdenum, 0 to 18 wt% iron, 0 to 1 wt% titanium, 0 to 0.15 wt% manganese, 0 to 0.15 wt% silver, 0 to 0.25 wt% carbon, 0 to 16 wt% tungsten, 0 to 2 wt% silicon, 0 to 2 wt% aluminum, 0 to 1 wt% iron, 30 to 68 wt% cobalt, 0 to 0.1 wt% boron, 0 to 0.15 wt% silver, and 0 to 2 wt% titanium. Standard MP35N alloy, a standard CoCr alloy, contains 18 to 22 wt% chromium, 32 to 38 wt% nickel, 8 to 12 wt% molybdenum, 0 to 2 wt% iron, 0 to 0.5 wt% silicon, 0 to 0.5 wt% manganese, 0 to 0.2 wt% carbon, 0 to 2 wt% titanium, 0 to 0.1 wt% boron, 0 to 0.1 wt% silver, 0 to 0.15 wt% silver, and the balance cobalt. Standard Phynox and Standard Elgiloy alloys, as defined herein, contain 38 to 42 wt% cobalt, 18 to 22 wt% chromium, 14 to 18 wt% iron, 13 to 17 wt% nickel, and 6 to 8 wt% molybdenum. Standard L605 alloy, as defined herein, contains 18 to 22 wt% chromium, 14 to 16 wt% tungsten, 9 to 11 wt% nickel, and the balance cobalt. As defined herein, a standard titanium-aluminum-vanadium alloy (TiAlV alloy) contains 5.5 to 6.75 wt% aluminum, 3.5 to 4.5 wt% vanadium, 85 to 93 wt% titanium, 0 to 0.4 wt% iron, and 0 to 0.2 wt% carbon.The standard Ti-6Al-4V alloy, which belongs to the standard TiAlV alloy, contains 3.5 to 4.5 wt% vanadium, 5.5 to 6.75 wt% aluminum, up to 0.3 wt% iron, up to 0.08 wt% carbon, up to 0.05 wt% yttrium, and the balance titanium. As defined herein, a standard aluminum alloy comprises 80 to 99 wt% aluminum, 0 to 12 wt% silicon, 0 to 5 wt% magnesium, 0 to 1 wt% manganese, 0 to 0.5 wt% scandium, 0 to 0.5 wt% beryllium, 0 to 0.5 wt% yttrium, 0 to 0.5 wt% cerium, 0 to 0.5 wt% chromium, 0 to 3 wt% iron, 0 to 0.5 wt% zinc, 0 to 0.5 wt% titanium, 0 to 3 wt% lithium, 0 to 0.5 wt% silver, 0 to 0.5 wt% calcium, 0 to 0.5 wt% zirconium, 0 to 1 wt% lead, 0 to 0.5 wt% cadmium, 0 to 0.05 wt% bismuth, 0 to 1 wt% nickel, 0 to 0.2 wt% vanadium, 0 to 0.1 wt% gallium, and 0 to 7 wt% copper. As defined herein, a standard nickel alloy comprises 30 to 98 wt% nickel, 5 to 25 wt% chromium, 0 to 65 wt% iron, 0 to 30 wt% molybdenum, 0 to 32 wt% copper, 0 to 32 wt% cobalt, 2 to 2 wt% aluminum, 0 to 6 wt% tantalum, 0 to 15 wt% tungsten, 0 to 5 wt% titanium, 0 to 6 wt% niobium, and 0 to 3 wt% silicon. As defined herein, a standard titanium alloy comprises 80 to 99 wt% titanium, 0 to 6 wt% aluminum, 0 to 3 wt% tin, 0 to 1 wt% palladium, 0 to 8 wt% vanadium, 0 to 15 wt% molybdenum, 0 to 1 wt% nickel, 0 to 0.3 wt% ruthenium, 0 to 6 wt% chromium, 0 to 4 wt% zirconium, 0 to 4 wt% niobium, 0 to 1 wt% silicon, 0.05 wt% cobalt, and 0 to 2 wt% iron. As defined herein, a standard tungsten alloy comprises 85 to 98 wt% tungsten, 0 to 8 wt% nickel, 0 to 5 wt% copper, 0 to 5 wt% molybdenum, and 0 to 4 wt% iron. As defined herein, a standard molybdenum alloy comprises 90 to 99.5 wt% molybdenum, 0 to 1 wt% nickel, 0 to 1 wt% titanium, 0 to 1 wt% zirconium, 0 to 30 wt% tungsten, 0 to 2 wt% hafnium, and 0 to 2 wt% lanthanum. As defined herein, a standard copper alloy comprises 55 to 95 wt% copper, 0 to 40 wt% zinc, 0 to 10 wt% tin, 0 to 10 wt% lead, 0 to 1 wt% iron, 0 to 5 wt% silicon, 0 to 12 wt% manganese, 0 to 12 wt% aluminum, 0 to 3 wt% beryllium, 0 to 1 wt% cobalt, and 0 to 20 wt% nickel. As defined herein, standard beryllium-copper alloys comprise 95 to 98.5 wt% copper, 1 to 4 wt% beryllium, 0 to 1 wt% cobalt, and 0 to 0.5 wt% silicon. As defined herein, standard titanium-nickel alloys (e.g., nickel-titanium alloys) comprise 42 to 58 wt% nickel and 42 to 58 wt% titanium. The rhenium effect has been observed when the atomic weight of rhenium in a metallic alloy is at least 15% (e.g., 15 to 99 atomic weights of rhenium in a metallic alloy and all values ​​and ranges therebetween).For example, for standard stainless steel alloys, the rhenium effect can begin to appear when the stainless steel alloy is modified to include at least 5% to 10% (and all values ​​and ranges therebetween) rhenium in the stainless steel alloy. For standard CoCr alloys, the rhenium effect can begin to appear when the CoCr alloy is modified to include at least 4.8% to 9.5% (and all values ​​and ranges therebetween) rhenium in the CoCr alloy. For standard TiAlV alloys, the rhenium effect can begin to appear when the TiAlV alloy is modified to include at least 4.5% to 9% (and all values ​​and ranges therebetween) rhenium in the TiAlV alloy. It is understood that the rhenium content in the above non-limiting examples can be greater than the minimum amount required to produce the rhenium effect in the metal alloy.

[0012] According to another and / or alternative aspect of this disclosure, the metal alloy used to partially or completely form an expandable medical device comprises at least 5 atomic weight percent (e.g., 5 to 99 atomic weight percent and all values ​​and ranges therebetween) rhenium and 0.1 to 96 wt percent (and all values ​​and ranges therebetween) one or more additives selected from the group consisting of: aluminum, boron, beryllium, bismuth, cadmium, calcium, cerium, chromium, cobalt, copper, gallium, gold, hafnium, iridium, iron, lanthanum, lanthanum oxide, lead, lithium, magnesium, manganese, molybdenum, nickel, niobium, osmium, palladium, platinum, rare earth metals, rhodium, ruthenium, scandium, silver, silicon, tantalum, technetium, tin, titanium, tungsten, vanadium, yttrium, zinc and / or zirconium, and the metal alloy optionally comprises 0 to 2 wt percent (and all values ​​and ranges therebetween) of other metals (e.g., metals other than additives), carbon, oxygen, phosphorus, sulfur, hydrogen and / or nitrogen, and the metal alloy exhibits a rhenium effect. In one non-limiting embodiment, the metal alloy used to partially or completely form the expandable medical device is a standard stainless steel alloy modified to contain at least 15 atomic weight % rhenium. In another non-limiting embodiment, the metal alloy used to partially or completely form the expandable medical device is a standard cobalt-chromium alloy modified to contain at least 15 atomic weight % rhenium. In another non-limiting embodiment, the metal alloy used to partially or completely form the expandable medical device is a standard TiAlV alloy modified to contain at least 15 atomic weight % rhenium. In another non-limiting embodiment, the metal alloy used to partially or completely form the expandable medical device is a standard aluminum alloy modified to contain at least 15 atomic weight % rhenium. In another non-limiting embodiment, the metal alloy used to partially or completely form the expandable medical device is a standard nickel alloy modified to contain at least 15 atomic weight % rhenium. In another non-limiting embodiment, the metal alloy used to partially or completely form the expandable medical device is a standard titanium alloy modified to contain at least 15 atomic weight % rhenium. In another non-limiting embodiment, the metal alloy used to partially or completely form the expandable medical device is a standard tungsten alloy modified to contain at least 15 atomic weight percent rhenium. In another non-limiting embodiment, the metal alloy used to partially or completely form the expandable medical device is a standard molybdenum alloy modified to contain at least 15 atomic weight percent rhenium. In another non-limiting embodiment, the metal alloy used to partially or completely form the expandable medical device is a standard copper alloy modified to contain at least 15 atomic weight percent rhenium. In another non-limiting embodiment, the metal alloy used to partially or completely form the expandable medical device is a standard beryllium-copper alloy modified to contain at least 15 atomic weight percent rhenium.

[0013] According to another and / or alternative aspect of this disclosure, the metal alloy used to partially or completely form the expandable medical device comprises rhenium and molybdenum, and the weight percentage of rhenium in the metal alloy is optionally greater than the weight percentage of molybdenum in the metal alloy, and the weight percentage of one or more additives in the metal alloy (e.g., aluminum, boron, beryllium, bismuth, cadmium, calcium, cerium, chromium, cobalt, copper, gallium, gold, hafnium, iridium, iron, lanthanum, lanthanum oxide, lead, lithium, magnesium, manganese, molybdenum, nickel, niobium, osmium, palladium, platinum, rare earth metals, rhodium, ruthenium, scandium, silver, silicon, tantalum, technetium, tin, titanium, tungsten, vanadium, yttrium, zinc and / or zirconium) is optionally greater than the weight percentage of molybdenum in the metal alloy, and the metal alloy optionally comprises 0 to 2% by weight of other metals (e.g., metals other than additives), carbon, oxygen, phosphorus, sulfur, hydrogen and / or nitrogen combinations. In a non-limiting embodiment, the metal alloy used to partially or completely form the expandable medical device comprises rhenium and molybdenum, and the weight percentage of rhenium plus the combined weight percentage of additives is greater than the weight percentage of molybdenum, and the metal alloy optionally comprises 0 to 2% by weight of other metals (e.g., metals other than additives), carbon, oxygen, phosphorus, sulfur, hydrogen and / or nitrogen.

[0014] According to another and / or alternative aspect of the invention, the metal alloy used to partially or completely form the expandable medical device comprises rhenium and molybdenum, and the atomic weight percentage of rhenium is in the ratio of the atomic weight percentage of one or more of bismuth, niobium, tantalum, tungsten, titanium, vanadium, chromium, manganese, yttrium, zirconium, technetium, ruthenium, rhodium, hafnium, osmium, copper and iridium to 0.4:1 to 2.5:1 (and all values ​​and ranges therebetween).

[0015] According to another and / or alternative aspect of this disclosure, the metal alloy used to partially or completely form an expandable medical device comprises at least 5 atomic weight percent (e.g., 5 to 99 atomic weight percent and all values ​​and ranges therebetween) rhenium plus at least two metals selected from the group consisting of molybdenum, bismuth, chromium, iridium, niobium, tantalum, titanium, yttrium, and zirconium, and the metal alloy comprising other elements and compounds is present in a content of 0 to 0.1 wt%. In another non-limiting embodiment, the metal alloy comprises rhenium, molybdenum, and chromium. In another non-limiting embodiment, the metal alloy comprises at least 35 wt percent (e.g., 35 to 75 wt percent and all values ​​and ranges therebetween) rhenium, and the metal alloy also comprises chromium. In a non-limiting embodiment, the metal alloy comprises at least 35% by weight rhenium, and at least 25% by weight (e.g., 25 to 49.9% by weight and all values ​​and ranges therebetween) of the metal alloy comprises chromium, and optionally 0.1 to 40% by weight (and all values ​​and ranges therebetween) of the metal alloy comprises one or more of the following: aluminum, boron, beryllium, bismuth, cadmium, calcium, cerium, chromium, cobalt, copper, gallium, gold, hafnium, iridium, iron, lanthanum, lanthanum oxide, lead, lithium, magnesium, manganese, molybdenum, nickel, niobium, osmium, palladium, platinum, rare earth metals, rhodium, ruthenium, scandium, silver, silicon, tantalum, technetium, tin, titanium, tungsten, vanadium, yttrium, zinc and / or zirconium, and the metal alloy optionally comprises 0 to 2% by weight (and all values ​​and ranges therebetween) of other metals, carbon, oxygen, phosphorus, sulfur, hydrogen and / or nitrogen combinations. In another non-limiting embodiment, the metal alloy comprises 15 to 50 atomic weight % rhenium (and all values ​​and ranges therebetween) and 0.5 to 70 atomic weight % chromium (and all values ​​and ranges therebetween). In another non-limiting embodiment, the metal alloy comprises 15 to 50 atomic weight % rhenium (and all values ​​and ranges therebetween) and 0.5 to 70 atomic weight % tantalum (and all values ​​and ranges therebetween). In another non-limiting embodiment, the metal alloy comprises 15 to 50 atomic weight % rhenium (and all values ​​and ranges therebetween) and 0.5 to 70 atomic weight % niobium (and all values ​​and ranges therebetween). In another non-limiting embodiment, the metal alloy comprises 15 to 50 atomic weight % rhenium (and all values ​​and ranges therebetween) and 0.5 to 70 atomic weight % titanium (and all values ​​and ranges therebetween). In another non-limiting embodiment, the metal alloy comprises 15 to 50 atomic weight % rhenium (and all values ​​and ranges therebetween) and 0.5 to 70 atomic weight % zirconium (and all values ​​and ranges therebetween). In another non-limiting embodiment, the metal alloy comprises 15 to 50 atomic weight % rhenium (and all values ​​and ranges therebetween) and 0.5 to 70 atomic weight % molybdenum (and all values ​​and ranges therebetween).In another non-limiting embodiment, the metal alloy comprises at least 15 atomic weight percent rhenium, greater than 50 wt percent titanium (e.g., 51 to 80 wt percent and all values ​​and ranges therein), 15 to 45 wt percent niobium (and all values ​​and ranges therein), 0 to 10 wt percent zirconium (and all values ​​or ranges therein), 0 to 15 wt percent tantalum (and all values ​​and ranges therein), and 0 to 8 wt percent molybdenum (and all values ​​or ranges therein).

[0016] The following are some non-limiting examples, by weight percentage, of metallic alloys that can be used to partially or completely form orthopedic medical devices:

[0017] In Examples 1 through 108, it should be understood that all the above ranges include any value between that range and any other range between the ranges described above. Any of the above values ​​including the ≤ sign includes the range from 0 to the specified value, as well as all values ​​and ranges in between.

[0018] According to another and / or alternative aspect of this disclosure, an expandable medical device is provided, which is at least partially formed of a metal alloy and is configured to be radially collapsed to a collapsed or coiled state for insertion into at least a portion of a fractured bone (optionally via a sheath or guide wire) and radially expanded to an expanded state for implantation of the expandable medical device at the fracture site of the fractured bone.

[0019] According to another and / or alternative aspect of this disclosure, an expandable medical device is provided, which may optionally be coated with a polymeric material (e.g., silicone, PTFE, ePTFE, polyurethane, polyolefin, hydrogel, biomaterial (e.g., pericardium or biopolymers such as collagen, gelatin, or hyaluronic acid derivatives)). The coating may be used to partially or completely encapsulate structures on the expandable medical device and / or fill openings on the expandable medical device.

[0020] According to another and / or alternative aspect of this disclosure, the metal alloy used to form at least a portion of an expandable medical device has one or more enhanced properties (e.g., strength, durability, hardness, biocompatibility, flexural properties, coefficient of friction, radial strength, flexibility, tensile strength, elongation at break, longitudinal elongation, stress-strain characteristics, reduced springback, radiation impermeability, thermal sensitivity, biocompatibility, extended fatigue life, crack resistance, crack propagation resistance, reduced magnetization, etc.), enhanced conformability during bending, less springback, increased yield strength, enhanced fatigue ductility, enhanced durability, extended fatigue life, reduced adverse tissue reactions, reduced metal ion release, reduced corrosion, reduced allergic reactions, enhanced hydrophilicity, reduced toxicity, reduced metal component thickness, enhanced bone fusion, and / or lower ion release into tissues. These improved physical properties of metal alloys can be achieved in expandable medical devices without increasing the volume and / or size of the expandable medical device, and in some cases, these improved physical properties can be obtained even when the volume and / or size of the expandable medical device is reduced compared to expandable medical devices made at least in part of standard stainless steel, standard titanium alloys, or standard cobalt and chromium alloys.Thus, the metallic alloy used to at least partially form the expandable medical device can therefore 1) increase the radiation impermeability of the expandable medical device, 2) increase the radial strength of the expandable medical device, 3) increase the yield strength and / or ultimate tensile strength of the expandable medical device, 4) improve the stress-strain characteristics of the expandable medical device, 5) improve the curling and / or expansion properties of the expandable medical device, 6) improve the bending and / or flexibility of the expandable medical device, 7) improve the strength and / or durability of the expandable medical device, 8) increase the hardness of the expandable medical device, 9) improve the resilience of the expandable medical device, 10) improve the biostability and / or biocompatibility of the expandable medical device, 11) increase the fatigue resistance of the expandable medical device, 12) resist cracking and crack propagation in the expandable medical device, 13) enable the manufacture of smaller and / or thinner expandable medical devices, 14) reduce the outer diameter of the curled expandable medical device, and 15) improve the expandable medical device's resistance to cracking when used and / or expanded in the treatment area. The conformal shape of the treatment area, 16) reducing the springback of the expandable medical device relative to the shape of the treatment area when it expands in the treatment area, 17) increasing the yield strength of the expandable medical device, 18) improving the fatigue ductility of the expandable medical device, 19) improving the durability of the expandable medical device, 20) improving the fatigue life of the expandable medical device, 21) reducing adverse tissue reactions after implantation of the expandable medical device, 22) reducing the release of metal ions after implantation of the expandable medical device, 23) reducing the corrosion of the expandable medical device after implantation of the expandable medical device, 24) reducing allergic reactions after implantation of the expandable medical device, 25) increasing the hydrophilicity of the expandable medical device, 26) reducing the thickness of the metal components of the expandable medical device, 27) improving bone fusion with the expandable medical device, 28) reducing the release of ions from the expandable medical device into the tissue, 29) reducing the magnetization of the expandable medical device when implanted in the patient, and / or 20) reducing the toxicity of the expandable medical device after implantation.

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

[0022] According to another and / or alternative aspect of this disclosure, the metal alloy optionally contains a certain amount of carbon and oxygen; however, this is not required. Both elements have been found to affect the formability and brittleness of the metal alloy. A controlled atomic ratio of carbon to oxygen in the metal alloy can also minimize the tendency of the metal alloy to form microcracks during the formation of the metal alloy as a frame for expandable medical devices and / or during in vivo use and / or expansion of the frame for expandable medical devices. The carbon to oxygen atomic ratio can be as low as about 0.2:1 (e.g., 0.2:1 to 50:1 and all values ​​and ranges therebetween). In a non-limiting formulation, the carbon to oxygen atomic ratio in the metal alloy is typically at least about 0.3:1. Typically, the carbon content of the metal alloy is less than about 0.1% by weight (e.g., 0 to 0.0999999% by weight and all values ​​and ranges therebetween), and more typically 0 to 0.01% by weight. Excessive carbon content can adversely affect the physical properties of the metal alloy. Generally, the oxygen content should be maintained at a very low level. In a non-limiting formulation, the oxygen content is less than about 0.1% by weight of the metal alloy (e.g., 0 to 0.0999999% by weight and all values ​​and ranges therebetween), and typically 0 to 0.01% by weight.

[0023] According to another and / or alternative aspect of this disclosure, the metal alloy optionally contains a controlled amount of nitrogen; however, this is not required. A large amount of nitrogen in the metal alloy may adversely affect its ductility. This, in turn, may adversely affect its elongation properties. In one non-limiting formulation, the metal alloy contains less than about 0.001% by weight of nitrogen (e.g., 0% by weight to 0.0009999% by weight and all values ​​and ranges therebetween). It should be believed that the nitrogen content should be less than the carbon or oxygen content in the metal alloy. In one non-limiting formulation, the carbon to nitrogen atomic ratio is at least about 1.5:1 (e.g., 1.5:1 to 400:1 and all values ​​and ranges therebetween). In another non-limiting formulation, the oxygen to nitrogen atomic ratio is at least about 1.2:1 (e.g., 1.2:1 to 150:1 and all values ​​and ranges therebetween).

[0024] According to another and / or alternative aspect of this disclosure, expandable medical devices are 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 therein).

[0025] According to another and / or alternative aspect of this disclosure, the metal alloy used to form all or part of the expandable medical device 1) is not coated, metal-sprayed, metal-sprayed, electroplated, and / or formed (e.g., cold-worked, hot-worked, etc.) on another metal, or 2) is not sprayed, coated, electroplated, coated, and / or formed on the metal alloy. It should be understood that in some applications, the metal alloy of this disclosure may be coated, metal-sprayed, coated, electroplated, and / or formed on another metal, or when forming all or part of the expandable medical device, another metal or metal alloy may be electroplated, metal-sprayed, coated, coated, and / or formed on the metal alloy.

[0026] According to another and / or alternative aspect of this disclosure, metal alloys can be used to form a) a coating (e.g., cladding, impregnation, spraying, electroplating, welding, plasma coating, etc.) on a portion or all of an expandable medical device, or b) a portion or all of the core of the expandable medical device. The composition of the coating differs from the composition of the material surface to which the metal alloy is coated. The coating thickness of the metal alloy is non-limiting (e.g., 1 µm to 1 inch and all values ​​and ranges therebetween). In one non-limiting example, an expandable medical device is provided in which the core or base layer of the expandable medical device is formed of a metal or metal alloy (e.g., chromium alloy, titanium, titanium alloy, stainless steel, ferroalloy, CoCr alloy, rhenium alloy, molybdenum alloy, tungsten alloy, Ta-W alloy, refractory metal alloy, MoTa alloy, MoRe alloy, etc.) or polymer or ceramic or composite material, and other layers of the coated expandable medical device are formed of different metals or metal alloys. The core or base layer and other layers of the expandable medical device may each form 10% to 99% of the entire cross-section of the expandable medical device (and all values ​​and ranges therebetween). When the outer metal coating is a rhenium-containing alloy, such an alloy can be used to create a hard surface at specific locations and across the entire surface of the expandable medical device. In another non-limiting embodiment, the core or base layer of the expandable medical device may be formed of a rhenium-containing alloy, and the coating may comprise one or more other materials (e.g., another type of metal or metal alloy [e.g., chromium alloys, titanium, titanium alloys, stainless steel, ferroalloys, CoCr alloys, rhenium alloys, molybdenum alloys, tungsten alloys, Ta-W alloys, refractory metal alloys, MoTa alloys, MoRe alloys, etc.), polymer coatings, ceramic coatings, composite material coatings, etc.). Non-limiting benefits of using rhenium-containing alloys in the core or inner layer of the expandable medical device may include reducing the size of the expandable medical device, increasing the strength of the expandable medical device, and / or maintaining or reducing the cost of the expandable medical device. As should be understood, the use of rhenium-containing alloys may provide other or additional advantages. The core or base layer size and / or thickness of the metal alloy is non-limiting. In one non-limiting example, an expandable medical device is provided that is at least partially formed of a layered material, wherein the top layer is formed of a material different from one or more other layers, and a rhenium-containing alloy forms one of the layers beneath the top layer, and the top layer is formed of a metal different from the rhenium-containing alloy (e.g., chromium alloy, titanium, titanium alloy, stainless steel, ferroalloy, CoCr alloy, rhenium alloy, molybdenum alloy, tungsten alloy, Ta-W alloy, refractory metal alloy, MoTa alloy, MoRe alloy, etc.). The core or lower or base layer and the outer layer of the layered material may each form 10% to 99% of the entire cross-section of the layered material (and all values ​​and ranges therebetween).

[0027] According to another and / or alternative aspect of this disclosure, the expandable medical device may optionally be shaped to be at least 80% (e.g., 80% to 100% and all values ​​and ranges therein) of the final net shape of the expandable medical device.

[0028] In another and / or alternative non-limiting embodiment of this disclosure, the average tensile elongation of the metal alloy used to at least partially form the expandable medical device is optionally at least about 20% (e.g., 20% to 50% average tensile elongation and all values ​​and ranges therebetween). An average tensile elongation of at least 20% of the metal alloy can facilitate proper expansion of the expandable medical device when positioned in a treatment area of ​​the body. The desired tensile elongation can be achieved through a unique combination of metals in the metal alloy to achieve the desired purity and composition of the alloy and the desired grain size of the metal alloy.

[0029] According to another and / or alternative aspect of this disclosure, the metal alloy is optionally formed at least partially by a die forging process; however, this is not required. In a non-limiting embodiment, the metal alloy is die forged to at least partially or completely achieve the final dimensions of one or more portions of the expandable medical device. The die forging die may be shaped to fit the final dimensions of the expandable medical device; however, this is not required.

[0030] According to another and / or alternative aspect of this disclosure, the metal alloy may optionally be nitrided; however, this is not required. When the expandable medical device is partially or completely formed, the nitrided layer on the metal alloy may act as a lubricating surface during optional drawing of the metal alloy.

[0031] According to another and / or alternative non-limiting aspect of this disclosure, the expandable medical device may optionally be partially (e.g., 1% to 99.99% and all values ​​and ranges therein) or completely coated with and / or contain one or more formulations. The term "formulation" includes, but is not limited to, substances, pharmaceuticals, biological products, veterinary products, medicines, and analogues or derivatives otherwise formulated and / or designed to prevent, inhibit, and / or treat one or more clinical and / or biological events and / or to promote healing. Non-limiting examples of clinical events that can be addressed by one or more formulations include, but are not limited to, viral, fungal, and / or bacterial infections; vascular diseases and / or conditions; lymphatic diseases and / or conditions; cancer; implant rejection; pain; nausea; swelling; organ failure; immune diseases and / or conditions; cell growth inhibitors; blood diseases and / or conditions; heart diseases and / or conditions; neuralgia diseases and / or conditions; fatigue; genetic diseases and / or conditions; trauma; cramps; muscle spasms; tissue repair; nerve repair; nerve regeneration, etc. The type and / or amount of the formulation included on / coated on the expandable medical device may vary. According to another and / or alternative aspect of this disclosure, one or more portions of the expandable medical device may optionally 1) include the same or different formulations, 2) include one or more formulations in the same or different amounts, 3) include the same or different polymer coatings, 4) include one or more polymer coatings with the same or different coating thicknesses, 5) allow one or more portions of the expandable medical device to controllably release and / or uncontrollably release one or more formulations, and / or 6) allow one or more portions of the expandable medical device to controllably release one or more formulations and allow one or more portions of the expandable medical device to uncontrollably release one or more formulations.

[0032] According to another and / or alternative aspect of this disclosure, one or more surfaces of the expandable medical device may optionally be treated to achieve desired coating properties of one or more formulations and one or more polymers applied to the expandable medical device. Such surface treatment techniques include, but are not limited to, cleaning, polishing, smoothing, nitriding, annealing, forging, cold working, etching (chemical etching, plasma etching, etc.), etc. It should be understood that other or additional surface treatment processes may be used prior to applying one or more formulations and / or polymers to the surface of the expandable medical device.

[0033] In another and / or alternative non-limiting aspect of this disclosure, the expandable medical device may optionally include a marking material that facilitates proper positioning of the expandable medical device within a body channel. The marking material is typically designed to be visible to: electromagnetic waves (e.g., X-rays, microwaves, visible light, infrared waves, ultraviolet light, etc.); sound waves (e.g., ultrasound, etc.); magnetic waves (e.g., MRI, etc.); and / or other types of electromagnetic waves (e.g., microwaves, visible light, infrared waves, ultraviolet waves, etc.).

[0034] According to another and / or alternative aspect of this disclosure, an expandable medical device or one or more regions of an expandable medical device may optionally be fabricated using one or more microelectromechanical manufacturing (MEMS) techniques (e.g., micromachining, laser micromachining, microforming, etc.); however, other or additional manufacturing techniques may be used.

[0035] According to another and / or alternative aspect of this disclosure, the expandable medical device may optionally include one or more surface structures (e.g., holes, channels, pits, ribs, slots, notches, bumps, teeth, needles, wells, cavities, grooves, etc.). These structures may be formed at least in part by MEMS (e.g., microfabrication, etc.) techniques and / or other types of techniques. In a non-limiting embodiment, at least a portion of the outer surface of the expandable medical device includes a plurality of ribs, bumps, teeth, and / or grooves for engaging the inner surface of the intramedullary cavity of the fractured bone to facilitate anchoring at least a portion of the expandable medical device within the intramedullary cavity as it expands within the cavity.

[0036] According to another and / or alternative aspect of this disclosure, the expandable medical device may optionally include one or more microstructures (e.g., microneedles, micropores, micropillars, microcones, micropyramids, microtubes, microparallelograms, microprisms, microhemispheres, teeth, ribs, spines, ratchet wheels, hinges, zippers, cable tie structures, etc.) located on the surface of the expandable medical device. As defined herein, a “microstructure” is a structure having at least one dimension (e.g., average width, average diameter, average height, average length, average depth, etc.) not exceeding about 2 mm and generally not exceeding about 1 mm.

[0037] In another and / or alternative aspect of this disclosure, the expandable medical device may optionally be an expandable device that can be expanded by using some other means (e.g., a balloon, etc.). The expandable medical device may be made of materials that do not have or substantially do not have shape memory properties.

[0038] According to another and / or alternative aspect of this disclosure, a near-net-shape process for expandable medical devices is optionally provided. In one non-limiting embodiment of this disclosure, a method is provided to increase the post-sintering strength of a powder-pressed material by imparting additional cold working. In one non-limiting embodiment, a green blank is pressed and then sintered. Subsequently, the sintered blank is pressed again to increase its mechanical strength by imparting cold working to the pressed and sintered blank.

[0039] According to another and / or alternative aspect of this disclosure, the metal alloy used to at least partially form an expandable medical device is initially formed as a billet, rod, tube, etc., and then finished into its final form by one or more finishing processes. The metal alloy billet, rod, tube, etc., can be formed by various techniques, such as, but not limited to, 1) melting the metal alloy and / or the metal forming the metal alloy (e.g., vacuum arc melting, etc.), and then extruding and / or casting the metal alloy into a billet, rod, tube, etc.; 2) melting the metal alloy and / or the metal forming the metal alloy to form a metal strip, and then rolling and welding the strip into a billet, rod, tube, etc.; 3) solidifying the metal powder of the metal alloy and / or the metal powder forming the metal alloy into a billet, rod, tube, etc.; or 4) 3D printing the metal powder of the metal alloy and / or the metal powder forming the metal alloy into a billet, rod, tube, etc. When the metal alloy is formed as a billet, the shape and size of the billet are not limited.

[0040] According to another and / or alternative aspect of this disclosure, when metal powders are consolidated to form a metal alloy into a billet, rod, tube, etc., the metal powders are pressed together to form a solid solution of the metal alloy into a near-net-shape expandable medical device, a near-net-shape component of an expandable medical device, a billet, rod, tube, etc. Typically, the pressing process is performed by isostatic pressing (i.e., applying uniform pressure from all sides of the metal powder); however, other processes can be used. When metal powders are pressed together in an isostatic manner, cold isostatic pressing (CIP) is typically used to consolidate the metal powders; however, this is not necessary. The pressing process can be performed in an inert atmosphere, an oxygen-reducing atmosphere (e.g., a mixture of hydrogen, argon, and hydrogen, etc.) and / or in a vacuum; however, this is not necessary.

[0041] According to another and / or alternative aspect of this disclosure, when the metal powder is used for 3D printing expandable medical devices, parts of expandable medical devices, blanks, rods, tubes, etc., the average particle size of the metal powder is optionally from 2 to 62 micrometers, and more specifically from about 5 to 49.9 micrometers, and the average density of the metal powder is greater than 5 g / cm³. 3 Furthermore, the metal powder is typically spherical, and the Hall flow rate (s / 50 g) is less than 30 seconds (e.g., 2 to 29.99 seconds and all values ​​and ranges in between).

[0042] According to another and / or alternative non-limiting aspect of this disclosure, the expandable medical device may be partially (e.g., 1% to 99.99% and all values ​​and ranges therein) or completely coated with an enhancement coating to improve one or more properties of the expandable medical device (e.g., changing the external color of the material having the coated surface, increasing surface hardness by using the coated surface, increasing the surface toughness of the material having the coated surface, reducing friction by using the coated surface, improving the scratch resistance of the material having the coated surface, improving the impact abrasion resistance of the coated surface, improving the corrosion and oxidation resistance of the coated material, forming a non-adhesive coated surface, improving the biocompatibility of the material having the coated surface, reducing the toxicity of the material having the coated surface, reducing the ion release of the material having the coated surface, the enhancement coating forming a less cellularly irritating surface around the coated surface after implantation of the expandable medical device, etc.). Non-limiting reinforcing coatings that can be applied to part or all of an expandable medical device include chromium nitride (CrN), diamond-like carbon (DLC), titanium nitride (TiN), titanium oxynitride (TiNOx), zirconium nitride (ZrN), zirconium oxide (ZrO2), zirconium-nitrogen-carbon (ZrNC), zirconium oxycarbon (ZrOC), zirconium oxynitride (ZnNxOy) [e.g., cubic ZrN:O, cubic ZrO2:N, tetragonal ZrO2:N, and monoclinic ZrO2:N phase coatings] and combinations of such coatings. In one non-limiting embodiment, one or more reinforcing coatings are optionally applied to part or all of the expandable medical device via a vacuum process that uses an energy source to evaporate the material and deposit a thin layer of the reinforcing coating material. When used, such vacuum coating processes may include physical vapor deposition (PVD) processes (e.g., sputtering deposition, cathodic arc deposition, or electron beam heating), chemical vapor deposition (CVD) processes, atomic layer deposition (ALD) processes, or plasma-enhanced chemical vapor deposition (PE-CVD) processes. In one non-limiting embodiment, the coating process is one or more of PVD, CVD, ALD, and PE-CVD, and the coating process is performed at a temperature of 200°C to 400°C (and all values ​​and ranges therebetween) for at least 10 minutes (e.g., 10 to 400 minutes and all values ​​and ranges therebetween). In another non-limiting embodiment, the coating process is one or more of PVD, CVD, ALD, and PE-CVD, and the coating process is performed at a temperature of 220°C to 300°C for 60 to 120 minutes.In another non-limiting embodiment, when one or more reinforcing coating materials are applied to the outer surface of an expandable medical device partially or entirely formed of a metal alloy, the reinforcing coating materials may optionally be combined with one or more metals in the metal alloy, and / or with nitrogen, oxygen, carbon, or other elements in and / or present in the atmosphere surrounding the metal alloy, to form a reinforcing coating on the outer surface of the metal alloy. In another non-limiting embodiment, when one or more reinforcing coating materials are applied to the outer surface of an expandable medical device partially or entirely formed of a metal alloy, the reinforcing coating materials may optionally be used to form various coating colors (e.g., gold, copper, brass, black, rose gold, chrome, blue, silver, yellow, green, etc.) on the outer surface of the metal alloy. In another non-limiting embodiment, the thickness of the reinforcing coating is greater than 1 nanometer (e.g., 2 nanometers to 100 micrometers and all values ​​and ranges therein), and is typically 0.1 to 25 micrometers, and more typically 0.2 to 10 micrometers. In another non-limiting embodiment, the hardness of the reinforcing coating may be at least 5 GPa (ASTM C1327-15 or ASTM C1624-05), typically 5 to 50 GPa (and all values ​​and ranges therebetween), more typically 10 to 25 GPa, and even more typically 14 to 24 GPa. In another non-limiting embodiment, the coefficient of friction (COF) of the reinforcing coating may be 0.04 to 0.2 (and all values ​​and ranges therebetween), and typically 0.6 to 0.15. In another non-limiting embodiment, the wear rate of the reinforcing coating may be 0.5 × 10⁻⁶. -7 mm 3 / Nm to 3×10 -7 mm 3 / Nm (all values ​​and ranges in between), and is typically 1.2 × 10 -7 mm 3 / Nm to 2×10 -7 mm 3 / Nm. In another non-limiting embodiment, the silicon-based precursor (e.g., trimethylsilane, tetramethylsilane, hexachlorodisilane, silane, dichlorosilane, trichlorosilane, silicon tetrachloride, tris(dimethylamino)silane, bis(tert-butylamino)silane, trimethylsilylamine, allyltrimethoxysilane, (3-aminopropyl)triethoxysilane, butyltrichlorosilane, n-sec-butyl(trimethylsilyl)amine, pentachlorodisilane, 1,2-dichlorotetramethyldisilane, [3-(diethylamino)silane, etc.) [Propyl]trimethoxysilane, 1,3-diethyl-1,1,3,3-tetramethyldisilazane, dimethoxydimethylsilane, dodecylcyclohexasilane, hexamethyldisilazane, isobutyl(trimethoxy)silane, methyltrichlorosilane, 2,4,6,8,10-pentamethylcyclopentasiloxane, pentamethyldisilazane, n-propyltriethoxysilane, silicon tetrabromide, silicon tetrabromide, etc. may optionally be used to facilitate the application of an enhanced coating to one or more portions or all of an expandable medical device.

[0043] According to another and / or alternative non-limiting aspect of this disclosure, expandable medical devices may be partially or completely coated with a reinforcing coating composition comprising a chromium nitride (CrN) coating. A portion or all of the expandable medical device may be partially or completely coated with a chromium nitride (CrN) coating. The reinforcing coating can be used to increase hardness, improve toughness, reduce friction, resist impact wear, improve corrosion and oxidation resistance, and / or form a surface with reduced adhesion when in contact with many different materials. According to a non-limiting embodiment, the chromium nitride (CrN) coating typically comprises 40 to 85 wt% Cr (and all values ​​and ranges therebetween), 15 to 60 wt% N (and all values ​​and ranges therebetween), 0 to 10 wt% Re (and all values ​​and ranges therebetween), 0 to 10 wt% Si (and all values ​​and ranges therebetween), 0 to 2 wt% O (and all values ​​and ranges therebetween), and 0 to 2 wt% C (and all values ​​and ranges therebetween). In a non-limiting coating process, all or part of the expandable medical device is initially coated with Cr metal. Cr metal coatings can be applied in an inert environment via PVD, CVD, ALD, and PE-CVD. The thickness of the Cr metal coating is 0.5 to 15 micrometers. Subsequently, the Cr metal coating is exposed to nitrogen and / or nitrogen-containing gaseous compounds to allow the nitrogen to react with the Cr metal coating, thereby forming a CrN layer on the outer surface of the Cr metal coating and / or the outer surface of the expandable medical device. Cr metal particles can optionally be mixed with nitrogen and / or nitrogen-containing gaseous compounds to promote the formation of the CrN coating. When using Cr metal particles, the initial Cr coating on the expandable medical device can optionally be removed. In another non-limiting embodiment, the reinforcing coating composition typically comprises 65 to 80 wt% Cr, 15 to 30 wt% N, 0 to 8 wt% Re, 0 to 1 wt% Si, 0 to 1 wt% O, and 0 to 1 wt% C.

[0044] According to another and / or alternative non-limiting aspect of this disclosure, expandable medical devices may be partially or completely coated with a reinforcing coating composition including a diamond-like carbon (DLC) coating. A portion or all of the expandable medical device may be partially or completely coated with a diamond-like carbon (DLC) coating. The reinforcing coating can be used to increase hardness, improve toughness, reduce friction, resist impact wear, improve corrosion and oxidation resistance, improve biocompatibility, and / or form a surface with reduced adhesion when in contact with many different materials. In one non-limiting embodiment, the diamond-like carbon (DLC) coating typically comprises 60 to 99.99% by weight of C (and all values ​​and ranges therebetween), 0 to 2% by weight of N (and all values ​​and ranges therebetween), 0 to 10% by weight of Re (and all values ​​and ranges therebetween), 0 to 20% by weight of Si (and all values ​​and ranges therebetween), and 0 to 2% by weight of O (and all values ​​and ranges therebetween). The carbon coating can be applied in an inert environment via PVD, CVD, ALD, and PE-CVD. The carbon layer can be applied using methane and / or acetylene gas; however, other or additional carbon sources can be used. The carbon coating thickness is 0.5 to 15 micrometers. In another non-limiting embodiment, all or part of the expandable medical device is coated with a reinforced coating composition typically comprising 90 to 99.99% by weight of C, 0 to 1% by weight of N, 0 to 8% by weight of Re, 0 to 1% by weight of Si, and 0 to 1% by weight of O.

[0045] According to another and / or alternative non-limiting aspect of this disclosure, an expandable medical device may be partially or completely coated with a reinforcing coating composition including a titanium nitride (TiN) coating. A portion or all of the outer surface of the expandable medical device may include a titanium nitride (TiN) coating. The reinforcing coating can be used to increase hardness, improve toughness, enhance corrosion and oxidation resistance, reduce friction, and / or form a less adhesive surface when in contact with many different materials. In one non-limiting embodiment, all or part of the outer surface of the expandable medical device is optionally initially coated with Ti metal. When applying the Ti metal coating, it can be applied in an inert environment via PVD, CVD, ALD, and PE-CVD. The thickness of the Ti metal coating is from 0.05 to 15 micrometers (and all values ​​and ranges therebetween). As should be understood, the initial Ti coating is optional. Subsequently, when applied, the Ti metal coating is exposed to nitrogen and / or nitrogen-containing gaseous compounds and optionally titanium particles to allow the nitrogen to react with the Ti metal coating and / or titanium particles, thereby forming a TiN layer on the outer surface of the Ti metal coating and / or the outer surface of the expandable medical device. If no titanium layer is pre-applied, a TiN coating can be formed by exposing the expandable medical device to titanium particles and nitrogen and / or nitrogen-containing gaseous compounds. The thickness of the TiN coating is typically 0.1 to 15 micrometers (and all values ​​and ranges in between), and is typically 0.2 to 2 micrometers.

[0046] According to another and / or alternative non-limiting aspect of this disclosure, expandable medical devices may be partially or completely coated with a reinforcing coating composition including a titanium oxide nitride (TiNOx) coating. A portion or all of the outer surface of the expandable medical device may include a titanium oxide nitride (TiNOx) coating. The reinforcing coating can be used to increase hardness, improve toughness, enhance corrosion and oxidation resistance, reduce friction, and / or form a less sticky surface when in contact with many different materials. In one non-limiting embodiment, all or part of the outer surface of the expandable medical device is optionally initially coated with Ti metal. When applying the Ti metal coating, it can be applied in an inert environment via PVD, CVD, ALD, and PE-CVD. The thickness of the Ti metal coating is from 0.05 to 15 micrometers (and all values ​​and ranges therebetween). As should be understood, the initial Ti coating is optional. Subsequently, the Ti metal coating is exposed to titanium particles and a nitrogen and oxygen mixture, which may contain nitrogen, oxygen, nitrogen-containing gaseous compounds, and / or oxygen-containing gaseous compounds, to induce a reaction between nitrogen and oxygen and the Ti metal coating (if such a coating is used) and / or the Ti metal particles to form a TiNOx layer on the outer surface of the Ti metal coating and / or the outer surface of the expandable medical device. The N / O ratio can be varied to control the amount of O in the TiNOx coating. If no titanium layer is pre-applied, the TiNOx coating can be formed by exposing the expandable medical device to titanium particles and a nitrogen and oxygen source, such as nitrogen, oxygen, nitrogen-containing gaseous compounds, and / or oxygen-containing gaseous compounds. When forming a TiNOx coating, the N / O ratio is typically from 1:10 to 10:1 (and all values ​​and ranges therebetween). The thickness of the TiNOx coating is typically from 0.1 to 15 micrometers (and all values ​​and ranges therebetween), and is typically from 0.2 to 2 micrometers. In another non-limiting embodiment, a TiNOx coating is applied to a portion or all of the outer surface of an expandable medical device, and the TiNOx coating is formed by: a) exposing a portion or all of the outer surface of the expandable medical device to Ti particles (PVD, CVD, ALD, and PE-CVD processes) and / or a Ti-containing solution to form a Ti layer on a portion or all of the expandable medical device, wherein the thickness of the Ti coating is 0.05 to 5 micrometers; and b) exposing the Ti coating to nitrogen and oxygen sources (such as nitrogen, oxygen, nitrogen-containing compounds, and / or oxygen-containing gas compounds) to form a TiNOx coating, wherein when the TiNOx coating is formed, the N to O ratio is typically 1:10 to 10:1, and wherein the coating thickness of the TiNOx coating is 0.2 to 5 micrometers.In another non-limiting embodiment, a TiNOx coating is applied to a portion or all of the outer surface of an expandable medical device, and the TiNOx coating is formed by exposing a portion or all of the outer surface of the expandable medical device to Ti particles and nitrogen and oxygen sources (such as nitrogen, oxygen, nitrogen-containing gas compounds and / or oxygen-containing gas compounds) to form the TiNOx coating, wherein the N to O ratio is typically 1:10 to 10:1 when the TiNOx coating is formed, and wherein the coating thickness of the TiNOx coating is 0.2 to 5 micrometers. In another non-limiting embodiment, the reinforcing coating composition typically comprises 20 to 85 wt% Ti (and all values ​​and ranges therebetween), 0.5 to 35 wt% N (and all values ​​and ranges therebetween), 0 to 10 wt% Re (and all values ​​and ranges therebetween), and 0.5 to 35 wt% O (and all values ​​and ranges therebetween). In another non-limiting embodiment, the TiNOx coating is formed on the expandable medical device by reactive physical vapor deposition in a vacuum chamber. Based on the oxygen-nitrogen ratio during vapor deposition, TiNOx coating deposits with defined composition and resistivity can be applied to the outer surface of expandable medical devices.

[0047] According to another and / or alternative non-limiting aspect of this disclosure, expandable medical devices may be partially or completely coated with a reinforcing coating composition including a zirconium nitride (ZrN) coating. The reinforcing coating can be used to increase hardness, improve toughness, enhance corrosion and oxidation resistance, reduce friction, and / or form a less adhesive surface when in contact with many different materials. In one non-limiting embodiment, all or part of the outer surface of the expandable medical device is initially coated with Zr metal. The Zr metal coating may be applied in an inert environment via PVD, CVD, ALD, and PE-CVD. The Zr metal coating thickness is 0.5 to 15 micrometers. Subsequently, the Zr metal coating is exposed to nitrogen and / or nitrogen-containing gaseous compounds to allow the nitrogen to react with the Zn metal coating, thereby forming a ZrN layer on the outer surface of the Zr metal coating and / or the outer surface of the expandable medical device. Zr metal particles may optionally be mixed with nitrogen and / or nitrogen-containing gaseous compounds to promote the formation of the ZrN coating. When using Zr metal particles, the initial Zr coating on the expandable medical device may optionally be removed. ZrN coatings have been found to produce a gold-enhanced coating color. In another non-limiting embodiment, the reinforcing coating composition typically comprises 35 to 90 wt% Zr (and all values ​​and ranges therebetween), 5 to 25 wt% N (and all values ​​and ranges therebetween), 0 to 10 wt% Re (and all values ​​and ranges therebetween), 0 to 20 wt% Si (and all values ​​and ranges therebetween), 0 to 2 wt% O (and all values ​​and ranges therebetween), and 0 to 2 wt% C (and all values ​​and ranges therebetween). In another non-limiting embodiment, the reinforcing coating composition typically comprises 80 to 90 wt% Zr, 10 to 20 wt% N, 0 to 8 wt% Re, 0 to 1 wt% Si, 0 to 1 wt% O, and 0 to 1 wt% C.

[0048] According to another and / or alternative non-limiting aspect of this disclosure, expandable medical devices may be partially or completely coated with a reinforcing coating composition including a zirconia (ZrO2) coating. The reinforcing coating can be used to increase hardness, improve toughness, enhance corrosion and oxidation resistance, reduce friction, and / or form a less adhesive surface when in contact with many different materials. In one non-limiting embodiment, all or part of the outer surface of the expandable medical device is initially coated with Zr metal. The Zr metal coating may be applied in an inert environment via PVD, CVD, ALD, and PE-CVD. The Zr metal coating thickness is 0.5 to 15 micrometers. Subsequently, the Zr metal coating is exposed to oxygen and / or oxygen-containing gas compounds to allow the oxygen to react with the Zn metal coating, thereby forming a zirconia (ZrO2) layer on the outer surface of the Zr metal coating and / or the outer surface of the expandable medical device. Zr metal particles may optionally be mixed with oxygen and / or oxygen-containing gas compounds to promote the formation of the ZrO2 coating. When using Zr metal particles, the initial Zr coating on the expandable medical device may optionally be removed. Zirconia (ZrO2) coatings have been found to produce a blue-enhanced coating color. In another non-limiting embodiment, the reinforcing coating composition typically comprises 35 to 90 wt% Zr (and all values ​​and ranges therebetween), 10 to 35 wt% O (and all values ​​and ranges therebetween), 0 to 2 wt% N (and all values ​​and ranges therebetween), 0 to 10 wt% Re (and all values ​​and ranges therebetween), 0 to 20 wt% Si (and all values ​​and ranges therebetween), and 0 to 2 wt% C (and all values ​​and ranges therebetween). In another non-limiting embodiment, the reinforcing coating composition typically comprises 70 to 80 wt% Zr, 20 to 30 wt% N, 0 to 8 wt% Re, 0 to 1 wt% Si, and 0 to 1 wt% C.

[0049] According to another and / or alternative non-limiting aspect of this disclosure, expandable medical devices may be partially or completely coated with a reinforcing coating composition comprising both a zirconium oxide (ZrO2) coating and a zirconium nitride (ZrN) coating. The reinforcing coating can be used to increase hardness, improve toughness, enhance corrosion and oxidation resistance, reduce friction, and / or form a less adhesive surface when in contact with many different materials. In one non-limiting embodiment, all or part of the outer surface of a metal alloy is initially coated with Zr metal. The Zr metal coating may be applied in an inert environment by PVD, CVD, ALD, and PE-CVD. The Zr metal coating thickness is 0.5 to 15 micrometers. Subsequently, the Zr metal coating is exposed to a) both oxygen and / or oxygen-containing gas compounds and nitrogen and / or nitrogen-containing gas compounds, b) nitrogen and / or nitrogen-containing gas compounds, and then exposed to oxygen and / or oxygen-containing gas compounds, or c) oxygen and / or oxygen-containing gas compounds, and then exposed to nitrogen and / or nitrogen-containing gas compounds. The coating compositions of zirconia (ZrO2) and zirconia nitride (ZrN) coatings are similar to or the same as those discussed above. As discussed above, Zr metal particles can optionally be mixed with oxygen and / or oxygen-containing gas compounds to promote the formation of the ZrO2 coating, and with nitrogen and / or nitrogen-containing gas compounds to promote the formation of the ZrN coating. When using Zr metal particles, the initial Zr coating on the expandable medical device can optionally be removed.

[0050] According to another and / or alternative non-limiting aspect of this disclosure, expandable medical devices may be partially or completely coated with a reinforcing coating composition including a zirconium oxycarbide (ZrOC) coating. The reinforcing coating can be used to increase hardness, improve toughness, enhance corrosion and oxidation resistance, reduce friction, and / or form a less adhesive surface when in contact with many different materials. In one non-limiting embodiment, all or part of the outer surface of a metal alloy is initially coated with Zr metal. The Zr metal coating may be applied in an inert environment by PVD, CVD, ALD, and PE-CVD. The Zr metal coating thickness is 0.5 to 15 micrometers. Subsequently, the Zr metal coating is exposed to a) both oxygen and / or oxygen-containing gas compounds and carbon and / or carbon-containing gas compounds (e.g., methane and / or acetylene), b) carbon and / or carbon-containing gas compounds, and then exposed to oxygen and / or oxygen-containing gas compounds, or c) oxygen and / or oxygen-containing gas compounds, and then exposed to carbon and / or carbon-containing gas compounds. Zr metal particles may optionally be mixed with oxygen and / or oxygen-containing gaseous compounds and carbon and / or carbon-containing gaseous compounds to promote the formation of a zirconium oxycarbide (ZrOC) coating. When using Zr metal particles, the initial Zr coating on an expandable medical device may optionally be eliminated. In another non-limiting embodiment, the reinforcing coating composition typically comprises 40 to 95 wt% Zr (and all values ​​and ranges therebetween), 5 to 25 wt% O (and all values ​​and ranges therebetween), 10 to 40 wt% C (and all values ​​and ranges therebetween), 0 to 2 wt% N (and all values ​​and ranges therebetween), 0 to 10 wt% Re (and all values ​​and ranges therebetween), and 0 to 20 wt% Si (and all values ​​and ranges therebetween). In another non-limiting embodiment, the reinforcing coating composition typically comprises 40 to 65 wt% Zr, 5 to 25 wt% O, 25 to 40 wt% C, 0 to 1 wt% N, 0 to 8 wt% Re, and 0 to 1 wt% Si.

[0051] According to another and / or alternative non-limiting aspect of this disclosure, one or more components of an expandable medical device may be partially or wholly coated with a reinforcing coating composition comprising zirconium oxynitride (ZnNxOy) [e.g., cubic ZrN:O, cubic ZrO2:N, tetragonal ZrO2:N, and monoclinic ZrO2:N phase coatings]. A portion or all of the outer surface of one or more components of the expandable medical device may comprise zirconium oxynitride (ZnNxOy). The reinforcing coating can be used to increase hardness, improve toughness, enhance corrosion and oxidation resistance, reduce friction, form a less adhesive surface when in contact with many different materials, and / or promote the formation of nitric oxide on the coating surface. In one non-limiting embodiment, all or a portion of the outer surface of one or more components of the expandable medical device is optionally initially coated with Zr metal. When applying the Zr metal coating, it can be applied in an inert environment via PVD, CVD, ALD, and PE-CVD. The Zr metal coating thickness is from 0.05 to 15 micrometers (and all values ​​and ranges therebetween). As should be understood, the initial Zr coating is optional. Subsequently, the Zr metallic coating is exposed to zirconium particles and a nitrogen and oxygen mixture, which may contain nitrogen, oxygen, nitrogen-containing gaseous compounds, and / or oxygen-containing gaseous compounds, to cause the nitrogen and oxygen to react with the Zr metallic coating (if such a coating is used) and / or with the Zr metallic particles to form a ZnNxOy layer on the outer surface of the Zr metallic coating and / or on the outer surface of one or more components of the expandable medical device. The N to O ratio can be varied to control the amount of O and N in the ZrNxOy coating. If no zirconium layer is pre-applied, the ZrNxOy coating can be formed by exposing the outer surface of one or more components of the expandable medical device to zirconium particles and a nitrogen and oxygen source, such as nitrogen, oxygen, nitrogen-containing gaseous compounds, and / or oxygen-containing gaseous compounds. When forming the ZrNxOy coating, the N to O ratio is typically from 1:10 to 10:1 (and all values ​​and ranges therebetween). The coating thickness of ZrNxOy coatings is typically 0.1 to 15 micrometers (and all values ​​and ranges in between), and is typically 0.2 to 2 micrometers.In another non-limiting embodiment, a ZrNxOy coating is applied to a portion or all of the outer surface of one or more components of an expandable medical device, and the ZrNxOy coating is formed by: a) exposing a portion or all of the outer surface of one or more components of the expandable medical device to Zr particles (PVD, CVD, ALD, and PE-CVD processes) and / or a Zr-containing solution to form a Zr layer on a portion or all of one or more components of the expandable medical device, wherein the thickness of the Zr coating is 0.05 to 5 micrometers; and b) exposing the Zr coating to nitrogen and oxygen sources (such as nitrogen, oxygen, nitrogen-containing compounds, and / or oxygen-containing gas compounds) to form the ZrNxOy coating, wherein when the ZrNxOy coating is formed, the N to O ratio is typically 1:10 to 10:1, and wherein the thickness of the ZrNxOy coating is 0.2 to 5 micrometers. In another non-limiting embodiment, a ZrNxOy coating is applied to a portion or all of the outer surface of one or more components of an expandable medical device, and the ZrNxOy coating is formed by exposing a portion or all of the outer surface of one or more components of the expandable medical device to Zr particles and nitrogen and oxygen sources (such as nitrogen, oxygen, nitrogen-containing gas compounds and / or oxygen-containing gas compounds) to form the ZrNxOy coating, wherein the N to O ratio is typically 1:10 to 10:1 when the ZrNxOy coating is formed, and wherein the coating thickness of the ZrNxOy coating is 0.2 to 5 micrometers. In another non-limiting embodiment, the reinforcing coating composition typically comprises 20 to 85 wt% Zr (and all values ​​and ranges therebetween), 0.5 to 35 wt% N (and all values ​​and ranges therebetween), and 0.5 to 35 wt% O (and all values ​​and ranges therebetween). In another non-limiting embodiment, the ZrNxOy coating is formed on one or more components of the expandable medical device by reactive physical vapor deposition in a vacuum chamber. Based on the oxygen-nitrogen ratio during vapor deposition, a ZrNxOy coating deposit with defined composition and resistivity can be applied to the outer surface of one or more components of an expandable medical device.

[0052] According to another and / or alternative non-limiting aspect of this disclosure, expandable medical devices may be partially or completely coated with a reinforcing coating composition including a zirconium-nitrogen-carbon (ZrNC) coating. The reinforcing coating can be used to increase hardness, improve toughness, enhance corrosion and oxidation resistance, reduce friction, and / or form a less viscous surface when in contact with many different materials. In one non-limiting embodiment, all or part of the outer surface of the expandable medical device is initially coated with Zr metal. The Zr metal coating may be applied in an inert environment by PVD, CVD, ALD, and PE-CVD. The Zr metal coating thickness is 0.5 to 15 micrometers. Subsequently, the Zr metal coating is exposed to nitrogen and / or nitrogen-containing gaseous compounds, and then to carbon and / or carbon-containing gaseous compounds (e.g., methane and / or acetylene). The color of the ZrNC will change depending on the amount of C and N in the coating. Zr metal particles may optionally be mixed with nitrogen and / or nitrogen-containing gaseous compounds and carbon and / or carbon-containing gaseous compounds to promote the formation of the ZrNC coating. When using Zr metal particles, the initial Zr coating on the expandable medical device can optionally be eliminated. In one non-limiting embodiment, the reinforcing coating composition typically comprises 40 to 95 wt% Zr (and all values ​​and ranges therebetween), 5 to 40 wt% N (and all values ​​and ranges therebetween), 5 to 40 wt% C (and all values ​​and ranges therebetween), 0 to 2 wt% O (and all values ​​and ranges therebetween), 0 to 10 wt% Re (and all values ​​and ranges therebetween), and 0 to 20 wt% Si (and all values ​​and ranges therebetween). In another non-limiting embodiment, the reinforcing coating composition typically comprises 40 to 80 wt% Zr, 5 to 25 wt% N, 5 to 25 wt% C, 0 to 1 wt% O, 0 to 8 wt% Re, and 0 to 1 wt% Si.

[0053] According to another and / or alternative non-limiting aspect of this disclosure, an expandable medical device is configured to be positioned at least partially or completely within the intramedullary cavity of bone. The expandable medical device is configured to be radially collapsed to a collapsed or coiled state for introduction into the intramedullary cavity of bone, and radially expanded to an expanded state for implantation at a desired location within the intramedullary cavity of bone. The expandable medical device is formed of a malleable expandable material that allows the expandable medical device to be coiled into a smaller profile so that it can be delivered and expanded once positioned at the desired location within the intramedullary cavity of bone. Expansion of the coiled frame of the expandable medical device can be achieved via an expansion device, such as, but not limited to, a balloon on a balloon catheter. During insertion of the expandable medical device into the intramedullary cavity of bone, the expandable medical device may optionally be at least partially surrounded by a flexible sheath. During insertion of the expandable medical device into the intramedullary cavity of bone, the expandable medical device may optionally be at least partially guided into the intramedullary cavity via a guidewire. Before, during, and / or after at least partially positioning the expandable medical device in the intramedullary cavity of the bone, a portion or all of the intramedullary cavity of the bone, including the expandable medical device, may optionally be filled with a column of surgical fluid (e.g., polymer cement, resin, etc.). The expandable medical device is configured to span the fracture site in the bone. The expandable medical device may optionally be introduced into the intramedullary cavity of the bone through an incision in the skin and an opening or notch in the fractured bone along a path that may run along the longitudinal axis of the intramedullary cavity in the bone. Once the expandable medical device is properly positioned in the bone, cement, adhesives, or other surgical fluids may optionally be used to achieve fixation and stabilization of the expandable medical device at the fracture site. The expandable medical device can be used for fixation and stabilization of long bone fractures; however, it can also be used for fixation and stabilization of other bones and structures. In another non-limiting embodiment, the expandable medical device may be configured to press against or otherwise engage the inner surface of the bone. The expandable medical device may be used during its insertion and expansion to assist in the movement and / or alignment of one or more bone fragments. Reintegration of bone fragments through the expandable medical device may be used to facilitate the fracture healing process. Expandable medical devices may optionally be used to a) assist in fracture reduction by applying outward force and pressure from within the intramedullary cavity of the fractured bone, and / or b) facilitate the movement or alignment of one or more bone fragments of the fractured bone toward or to a more favorable or desired position.

[0054] According to another and / or alternative non-limiting aspect of this disclosure, the size and shape of the expandable medical device may be designed to a) expand with sufficient force to facilitate the movement and repositioning of one or more bone fragments of a fractured bone that has been compressed or otherwise invaded the intramedullary cavity (e.g., to drive such bone fragments radially outward and generally toward a position more aligned with the opposite fracture ends, thereby facilitating the reintegration of fragments during fracture healing), b) expand to fill gaps or voids in the cortical bone wall or endosteal tissue at or near the fracture site (e.g., if one or more bone fragments have been separated from the fracture site and have not been compressed, aligned, or otherwise brought back to the vicinity of the fracture site, the expandable medical device may be configured to expand to fill spaces that were previously occupied by fragments that were not present), and / or c) provide support to the fracture site without the need for additional structures (e.g., sheaths, surgical fluids, etc.).

[0055] According to another and / or alternative non-limiting aspect of this disclosure, the expandable medical device may optionally include one or more gripping members disposed on or along the outer surface of the expandable medical device to securely attach to the inner wall of the intramedullary cavity of the bone.

[0056] According to another and / or alternative non-limiting aspect of this disclosure, the expandable medical device has one or more of the following advantages: a) less invasiveness (e.g., 1 to 3 mm punctures in the upper extremities; 2 to 6 mm punctures in the lower extremities), b) no screws or plates impacting tendons, muscles, etc., c) complete internal fixation within the bone, d) preservation of bone marrow, which is essential for healing, e) insertion of a sheath into the expandable medical device to allow bone marrow to drain at any time, so that the bone marrow can be pushed out after the expandable medical device is inserted into the bone and can be re-injected into the bone, f) reduced risk of pulmonary embolism due to bone marrow embolism, g) the expandable medical device can be designed to be shortened to create an internal mechanism for fracture reduction / compression during expansion of the expandable medical device, h) the end of the expandable medical device can be expanded first so that the end of the expandable medical device is fixed to the bone before the middle portion of the expandable medical device is fully expanded. In this context, the expansion of the middle portion of the expandable medical device generates longitudinal pressure on the fractured bone due to the shortening of the expandable medical device during expansion, i) during the expansion of the expandable medical device in the bone, screws are not required to anchor the end of the expandable medical device in the bone (e.g., when expanding the expandable medical device, the typical balloon pressure is 10 to 20 atmospheres ~ 150 to 300 pounds per square inch, so such expansion force should hold the end of the expandable medical device in the bone without the need for screws; however, screws may still be used if necessary, and / or j) the expandable medical device may include one or more markers to facilitate placement of the expandable medical device in the fractured bone.

[0057] According to another and / or alternative non-limiting aspect of this disclosure, a second expandable medical device may optionally be inserted into the interior of a first expandable medical device to increase the strength and / or stiffness of the expandable medical device system at the fracture site. For example, the first expandable medical device may be inserted into and expand at the fracture site. Thereafter, the second expandable medical device may optionally be partially or completely inserted into a portion or all of the interior of the expanded first expandable medical device. Typically, the longitudinal length of the expanded second expandable medical device is less than the longitudinal length of the expanded first expandable medical device (e.g., less than 20% to 80% and all values ​​and ranges therebetween); however, this is not required. After the second expandable medical device is partially or completely inserted into a portion or all of the interior of the expanded first expandable medical device and subsequently expands, the expanded second expandable medical device typically expands the length of the fracture site. The second expandable medical device may be configured to a) shorten upon expansion, such that the longitudinal length of the expanded second expandable medical device is at least 15% smaller than the longitudinal length of the coiled or unexpanded second expandable medical device (e.g., 15% to 60% smaller and all values ​​and ranges therebetween), or b) not shorten or substantially not shorten upon expansion, such that the longitudinal length of the expanded second expandable medical device is no more than 10% smaller (e.g., 0% to 10% smaller than the longitudinal length of the coiled or unexpanded second expandable medical device and all values ​​and ranges therebetween). When the expanded second expandable medical device is configured to shorten, the reduced longitudinal length of the expanded second expandable medical device can facilitate further pulling the fractured bone together. The use of the expanded second expandable medical device can result in increased rigidity and / or strength in the regions of both expanded expandable medical devices to provide additional support to the fractured area of ​​the bone. The materials used to form the first and second expandable medical devices may be the same or different. One or both of the first and second expandable medical devices may include a reinforcing coating and / or a biological agent.

[0058] A non-limiting object of this disclosure is to provide an expandable medical device that can be partially or completely inserted into a fractured bone to facilitate fixation, repair, and stabilization of the fractured bone.

[0059] Another and / or alternative non-limiting object of this disclosure is to provide an expandable medical device formed partly or entirely of a rhenium-containing metal alloy, which can be partially or completely inserted into a fractured bone to facilitate fixation, repair and stabilization of the fractured bone.

[0060] Another and / or alternative non-limiting object of this disclosure is to provide an expandable medical device formed partially or entirely of a rhenium-containing metal alloy, which can be partially or completely inserted into a fractured bone to facilitate fixation, repair, and stabilization of the fractured bone, wherein the metal alloy used to partially or completely form the expandable medical device has a sufficient amount of rhenium such that the ductility and tensile strength of the metal alloy are improved compared to similar metal alloys that do not contain rhenium.

[0061] Another and / or alternative non-limiting object of this disclosure is to provide an expandable medical device formed partly or entirely of a rhenium-containing metal alloy exhibiting a rhenium effect.

[0062] Another and / or alternative non-limiting object of this disclosure is to provide an expandable medical device formed partly or entirely of a rhenium-containing metal alloy exhibiting a rhenium effect and containing at least 15 atomic weight% rhenium.

[0063] Another and / or alternative non-limiting object of this disclosure is to provide an expansionable medical device system at the fracture site by using a second expansionable medical device inserted into the interior of the first expansion expansionable medical device.

[0064] Another and / or alternative non-limiting object of this disclosure is to provide an expandable medical device for treating fracture sites in bone with an intramedullary cavity; the expandable medical device includes an expandable frame having an open-unit configuration; the expandable frame includes a plurality of interconnected struts; the expandable frame has an unexpanded shape and size such that it can be inserted into the intramedullary cavity; the expandable frame has an expanded shape and size such that it can be fixed in the intramedullary cavity while traversing the fracture site of the fractured bone; the expandable frame has a longitudinal length sufficient to completely span the fracture site; the expandable frame is capable of expanding from a first cross-sectional dimension in the unexpanded state to a second cross-sectional dimension in the expanded state; the cross-sectional area of ​​the expandable frame in the second cross-sectional dimension is greater than the first cross-sectional dimension. The expandable frame has a cross-sectional area at the first cross-sectional dimension; the longitudinal length of the expandable frame in the unexpanded state is greater than the longitudinal length of the expandable frame in the expanded state; the expandable frame has sidewalls including a plurality of openings; the expandable frame is formed at least partially from a metal alloy comprising at least 5 atomic weight percent (e.g., 5 to 99 atomic weight percent and all values ​​and ranges therebetween) rhenium and an additive material; the additive material comprises one or more metals selected from the group consisting of: aluminum, boron, beryllium, bismuth, cadmium, calcium, cerium, chromium, cobalt, copper, gallium, gold, hafnium, iridium, iron, lanthanum, lithium, magnesium, manganese, molybdenum, nickel, niobium, osmium, palladium, platinum, rare earth metals, rhodium, ruthenium, scandium, silver, silicon, tantalum, technetium, tin, titanium, tungsten, vanadium, yttrium, zinc, and zirconium; the rhenium and the additive material constitute at least 90% by weight of the rhenium alloy.

[0065] Another and / or alternative non-limiting object of this disclosure is to provide an expandable medical device at least partially coated with a biocompatible material, the biocompatible material comprising a) a biological agent, b) a titanium oxide nitride (TiNOx) coating, c) a titanium nitride (TiN) coating, d) a chromium nitride (CrN) coating, e) a diamond-like carbon (DLC) coating, f) a zirconium nitride (ZrN) coating, g) a zirconium oxide (ZrO2) coating, h) a zirconium-nitrogen-carbon (ZrNC) coating, i) a zirconium oxycarbonate (ZrOC) coating and / or j) a zirconium oxynitride (ZrNxOy) coating.

[0066] Another and / or alternative non-limiting object of this disclosure is to provide a method for repairing a fractured bone, the method comprising: a) providing a fractured bone, the fractured bone comprising a first bone portion and a second bone portion and a fracture site located between the first bone portion and the second bone portion; the fracture site having a fracture site width; each of the first bone portion and the second bone portion of the fractured bone comprising an intramedullary cavity; b) providing an expandable medical device for treating the fracture site in the fractured bone; the expandable medical device comprising an expandable frame having an open-unit configuration; the expandable frame comprising Multiple interconnected struts; the expandable frame has an unexpanded shape and size, allowing it to be inserted into the intramedullary cavity; the expandable frame has an expanded shape and size, allowing it to be fixed within the intramedullary cavity while traversing the fracture site of the fractured bone; the expandable frame has a longitudinal length sufficient to completely span the fracture site; the expandable frame is capable of expanding from a first cross-sectional dimension in the unexpanded state to a second cross-sectional dimension in the expanded state; the cross-sectional area of ​​the expandable frame in the second cross-sectional dimension is greater than the cross-sectional area of ​​the expandable frame in the first cross-sectional dimension; the expandable frame has a cross-sectional dimension of... The longitudinal length of the expanded frame in its unexpanded state is greater than the longitudinal length of the expandable frame in its expanded state; the expandable frame has sidewalls comprising a plurality of openings; the expandable frame is at least partially formed of a metal alloy comprising at least 5 atomic weight percent (e.g., 5 to 99 atomic weight percent and all values ​​and ranges therebetween) rhenium and an additive material; the additive material comprises one or more metals selected from the group consisting of: aluminum, boron, beryllium, bismuth, cadmium, calcium, cerium, chromium, cobalt, copper, gallium, gold, hafnium, iridium, iron, lanthanum, lithium, magnesium, manganese, molybdenum, nickel, niobium, osmium, palladium, platinum, rare earth metals, rhodium, ruthenium, scandium, Silver, silicon, tantalum, technetium, tin, titanium, tungsten, vanadium, yttrium, zinc, and zirconium; the rhenium and the additive material constitute at least 90% by weight of the rhenium alloy; c) when the expandable medical device is in the unexpanded state, inserting the expandable medical device into the intramedullary cavity such that at least a portion of the expandable medical device is positioned in the first bone portion and the second bone portion and traverses the fracture site; and d) expanding the expandable medical device in the intramedullary cavity to the expanded state to repair the fractured bone; and wherein the expansion of the expandable medical device causes the first bone portion and the second bone portion to thereby reduce the width of the fracture site.

[0067] Another and / or alternative non-limiting object of this disclosure is to provide a method for repairing fractured bone, wherein an expandable medical device includes a proximal portion, a distal portion, and an intermediate portion; and wherein the expansion step includes expanding the proximal and / or distal portions of the expandable medical device prior to expanding the intermediate portion; and wherein the pre-expansion of the proximal and / or distal portions results in the proximal and / or distal portions being at least partially anchored in the intramedullary cavity prior to the expansion of the intermediate portion.

[0068] Another and / or alternative non-limiting object of this disclosure is to provide a method for repairing fractured bone, wherein an expandable medical device includes a proximal portion, a distal portion, and an intermediate portion; and the method further includes the steps of fixing the proximal portion and / or the distal portion in the intramedullary cavity by: a) inserting one or more screws or posts into the fractured bone to restrict movement of the proximal portion and / or the distal portion in the intramedullary cavity, and / or b) inserting adhesives and / or cement into the intramedullary cavity to restrict movement of the proximal portion and / or the distal portion in the intramedullary cavity.

[0069] Another and / or alternative non-limiting object of this disclosure is to provide a method for repairing fractured bone, the method further comprising the steps of: a) removing at least a portion of bone marrow from the intramedullary cavity before inserting the expandable medical device into the intramedullary cavity; and b) after the step of expanding the expandable medical device in the intramedullary cavity, inserting at least a portion of the removed bone marrow into the intramedullary cavity, at least partially.

[0070] Another and / or alternative non-limiting object of this disclosure is to provide a method for repairing fractured bone, the method further comprising the step of using a sheath to facilitate insertion of an expandable medical device into the intramedullary cavity; the sheath comprising a tubular structure having a longitudinal cavity; the longitudinal cavity having dimensions and shape configured such that the expandable medical device in the unexpanded state can move through the longitudinal cavity; at least a portion of the sheath optionally being formed of an elastic material.

[0071] Another and / or alternative non-limiting object of this disclosure is to provide a method for repairing fractured bone, the method further comprising the step of using a guidewire to facilitate the insertion of a portion of an expandable medical device into the intramedullary cavity; the guidewire having sufficient flexibility and stiffness to allow the expandable medical device in the unexpanded state to pass through the intramedullary cavity and move along the guidewire.

[0072] Another and / or alternative non-limiting object of this disclosure is to provide a method for repairing fractured bone, the method further comprising the steps of: a) providing a second expandable medical device; b) inserting the second expandable medical device into the interior of an expanded expandable medical device; and c) expanding the second expandable medical device within the expanded expandable medical device to increase the strength and / or stiffness around the fracture area.

[0073] Another and / or alternative non-limiting object of this disclosure is to provide a method for repairing fractured bone, wherein the longitudinal length of a second expandable medical device in an expanded state is less than the longitudinal length of the expanded expandable medical device.

[0074] Another and / or alternative non-limiting object of this disclosure is to provide a method for repairing fractured bone, wherein a second expandable medical device is configured to a) shorten upon expansion, such that the longitudinal length of the expanded second expandable medical device is at least 10% smaller than the longitudinal length of the unexpanded second expandable medical device.

[0075] Another and / or alternative non-limiting object of this disclosure is to provide a method for repairing fractured bone, wherein when a second expandable medical device expands within the expandable medical device, the end of the second expandable medical device does not extend beyond the end of the expandable medical device in the expanded state.

[0076] Another and / or alternative non-limiting object of this disclosure is to provide an expandable device for treating fracture sites in bone with an intramedullary cavity; the expandable device includes an expandable frame; the expandable frame has an unexpanded shape and size such that it can be inserted into the intramedullary cavity; the expandable frame has an expanded shape and size such that it can be fixed in the intramedullary cavity while traversing the fracture site of the fractured bone; the expandable frame has a longitudinal length sufficient to completely span the fracture site; the expandable frame is capable of expanding from a first cross-sectional dimension in the unexpanded state to a second cross-sectional dimension in the expanded state; the cross-sectional area of ​​the expandable frame in the second cross-sectional dimension is greater than that of the unexpanded frame. The expandable frame has a cross-sectional area at the first cross-sectional dimension; the longitudinal length of the expandable frame in the unexpanded state is greater than the longitudinal length of the expandable frame in the expanded state; the expandable frame has sidewalls including one or more openings; the expandable frame is formed at least partially from a metal alloy comprising at least 5 atomic weight percent (e.g., 5 to 99 atomic weight percent and all values ​​and ranges therebetween) rhenium and an additive material; the additive material comprises one or more metals selected from the group consisting of: aluminum, boron, beryllium, bismuth, cadmium, calcium, cerium, chromium, cobalt, copper, gallium, gold, hafnium, iridium, iron, lanthanum, lithium, magnesium, manganese, molybdenum, nickel, niobium, osmium, palladium, platinum, rare earth metals, rhodium, ruthenium, scandium, silver, silicon, tantalum, technetium, tin, Titanium, tungsten, vanadium, yttrium, zinc, and zirconium; rhenium and additive materials constitute at least 90% by weight of the rhenium alloy, and wherein the rhenium alloy optionally contains 0 to 2% by weight of other metals, carbon, oxygen, phosphorus, sulfur, hydrogen, and nitrogen; the other metals are metals other than rhenium and additive materials, and wherein the expandable framework is optionally at least partially coated with a biocompatible material; the biocompatible material optionally includes a) a biological agent, b) a titanium oxide nitride (TiNOx) coating, c) a titanium nitride (TiN) coating, d) a chromium nitride (CrN) coating, e) a diamond-like carbon (DLC) coating, f) a zirconium nitride (ZrN) coating, g) a zirconium oxide (ZrO2) coating, h) a zirconium-nitrogen-carbon (ZrNC) coating, i) a zirconium oxycarbonate (ZrO2) coating, and d) a zirconium oxide (ZrO2) coating. The expandable frame is coated with a ZrOC coating and / or a zirconium oxynitride (ZrNxOy) coating, wherein the expandable frame is optionally at least partially coated with a biocompatible material, and wherein the expandable frame is optionally in a generally hollow tubular shape, and wherein the biocompatible material optionally contains no more than 0.1 wt% nickel and / or no more than 0.1 wt% cobalt, and wherein the metal alloy of the expandable frame optionally contains no more than 0.1 wt% nickel and / or no more than 0.1 wt% cobalt, and wherein the biocompatible material is optionally at least partially coated on a metal adhesion coating, and wherein the metal adhesion coating optionally contains no more than 0.1 wt% nickel and / or no more than 0.1 wt% cobalt.

[0077] Other objects, advantages and novel features of this disclosure will become apparent from the following detailed description of the present disclosure when considered in conjunction with the accompanying drawings. Attached Figure Description

[0078] Non-limiting and non-exhaustive embodiments are described with reference to the accompanying drawings, wherein, unless otherwise specified, the same reference numerals refer to the same parts in the various views. The dimensions and relative positions of elements in the drawings are not necessarily drawn to scale. For example, the shapes of various elements are selected, enlarged, and positioned to improve the readability of the drawings. Specific shapes of the drawn elements have been selected for easy identification in the drawings. Reference can now be made to the accompanying drawings, which illustrate various embodiments of this disclosure that can be taken in physical form and in certain arrangements of parts and portions, wherein: Figures 1 to 3 Various non-limiting prior art bone fixation devices are shown, along with non-limiting disadvantages that may be associated with such bone fixation devices.

[0079] Figure 4 A list of non-limiting expandable medical devices according to this disclosure and a list of non-limiting features of such expandable medical devices are presented.

[0080] Figures 5A to 5D A non-limiting method for repairing fractures using a non-limiting expandable medical device according to this disclosure is demonstrated.

[0081] Figures 6A and 6B illustrate a non-limiting expandable medical device according to the present disclosure in an unexpanded state and an expanded state, and also show that the non-limiting expandable medical device in the expanded state has a shorter longitudinal length than the non-limiting expandable medical device in the unexpanded state.

[0082] Figures 7A to 7D illustrate non-limiting methods for repairing fractures using two non-limiting expandable medical devices according to this disclosure.

[0083] Figure 8 It demonstrates that non-restrictive bones can be repaired using expandable medical devices. Detailed Implementation

[0084] Although specific terms are used in the following description for clarity, these terms refer only to the specific structures of the selected embodiments used for illustration in the drawings and are not intended to limit or restrict the scope of this disclosure. In the drawings and the following description, it should be understood that the same numerical designations refer to components having the same function.

[0085] Unless the context clearly indicates otherwise, the singular forms “a”, “an”, and “the” contain plural indicators.

[0086] As used in the specification and claims, the term "comprising" may include embodiments of "consisting of" and "substantially consisting of". The terms "comprise(s)", "include(s)", "having", "has", "can", "contain(s)", and variations thereof, as used herein, are intended to be open-ended transitional phrases, terms, or words that require the presence of a specified ingredient / step and permit the presence of other ingredients / steps. However, such descriptions should be interpreted as also describing the composition or process as "consisting of the listed ingredients / steps" and "substantially consisting of the listed ingredients / steps", which allows for the presence of only the specified ingredient / step, and any unavoidable impurities that may result therefrom, and excludes other ingredients / steps.

[0087] The numerical values ​​in the specification and claims of this application should be understood to include the same numerical values ​​as when reduced to the same number of significant figures, and the differences from said values ​​are less than the experimental errors of conventional measurement techniques belonging to the type described in this application for determining values.

[0088] All ranges disclosed herein include the listed endpoints and can be combined independently (e.g., the range “2 g to 10 g” includes the endpoints 2 g and 10 g as well as all intermediate values).

[0089] The terms “about” and “approximately” can be used for any numerical value that can vary without altering the fundamental function of that value. When used with a range, “about” and “approximately” also disclose a range defined by the absolute values ​​of the two endpoints; for example, “about 2 to about 4” also discloses a range of “2 to 4”. Typically, the terms “about” and “approximately” can refer to plus or minus 10% of the number referred to.

[0090] While exemplary embodiments of the disclosed methods may be described in a specific order for ease of presentation, it should be understood that the disclosed embodiments may include an order of operations other than the specific order disclosed. For example, in some cases, the operations described in order may be rearranged or performed simultaneously. Furthermore, the descriptions and disclosures provided in association with a particular embodiment are not limited to that embodiment and may be applied to any of the disclosed embodiments.

[0091] For simplicity, the accompanying drawings may not show the various ways in which the systems, methods, and apparatuses disclosed herein can be used in conjunction with other systems, methods, and apparatuses (which can be readily discerned by those skilled in the art based on this disclosure). Additionally, the description sometimes uses terms such as “produce” and “provide” to describe the disclosed methods. These terms are abstract concepts of actual operations that can be performed. The actual operations corresponding to these terms may vary from specific implementation to specific implementation and can be readily discerned by those skilled in the art based on this disclosure.

[0092] This disclosure relates to an expandable medical device that can be partially or completely inserted into a fractured bone to facilitate fixation, repair, and stabilization of the fractured bone. The expandable medical device is partially or completely formed of a rhenium-containing metal alloy, and the rhenium content of the metal alloy allows it to have improved ductility and tensile strength compared to the same or similar metal alloys without rhenium. The outer surface of the expandable medical device may optionally be coated with a reinforcing coating.

[0093] Now for reference Figure 4 A fractured bone B is shown, comprising an expandable medical device 100 positioned within the intramedullary cavity IC of the fractured bone B. The expandable medical device 100 is positioned within the intramedullary cavity IC such that it covers the fracture area F of the fractured bone B. Prior to insertion of the expandable medical device 100 into the intramedullary cavity IC, the bone marrow BM has been partially or completely removed from the intramedullary cavity IC. A guidewire GW is shown, which may optionally be used to facilitate guidance of the expandable medical device 100 during insertion into the intramedullary cavity IC. The base of the fractured bone includes a channel C cut into the fractured bone, allowing the expandable medical device 100 to be inserted into the intramedullary cavity IC. An insertion tool IC is used to insert the expandable medical device 100 into the intramedullary cavity IC. The insertion tool IC may optionally include a sheath S positioned within the channel C and may be used to facilitate insertion of the expandable medical device 100 through the channel C into the intramedullary cavity IC.

[0094] Figure 4 Several non-limiting advantages of the expandable medical device 100 are listed below: ● The use of the expandable medical device 100 is minimally invasive. Typically, only a 3 to 4 mm incision is required in the bone to insert the expandable medical device 100 into the intramedullary cavity IC of the fractured bone B. Existing intramedullary nails typically require an incision of approximately 15 mm within the bone. The significantly smaller incision in the fractured bone improves the healing rate of the fractured bone and reduces the incidence of bone damage during incision formation. ● Minimize bone marrow loss during fracture repair because, after an expandable medical device has been inserted into the intramedullary cavity, any removed or displaced bone marrow is reinjected into the cavity to maintain bone marrow integrity and promote healing of the fractured bone.

[0095] ● The use of the expandable medical device 100 achieves true "internal fixation" of fractures without the need for external devices (e.g., screws, external support structures, etc.). The "internal fixation" feature of the expandable medical device also ensures no impact on the soft tissues, tendons, and muscles surrounding the fractured bone, thus causing little or no damage to the connective tissues around the fractured bone during bone repair.

[0096] ● Compared to rigid rods, the use of the expandable medical device 100 improves conformability to the shape of the intramedullary cavity of the fractured bone. The shape of the intramedullary cavity of a fractured bone is typically non-linear, especially when the bone is fractured. The flexibility of the frame of the expandable medical device allows the frame to bend during insertion into the intramedullary cavity. Thus, the flexible frame of the expandable medical device can better conform to the non-linear shape of the intramedullary cavity of the fractured bone, thereby a) improving fracture repair, and b) reducing damage to the intramedullary cavity of the fractured bone during insertion into the intramedullary cavity.

[0097] ● Using the expandable medical device 100 to repair fractured bones can reduce the risk of pulmonary embolism.

[0098] ● The expandable medical device 100 is configured such that its longitudinal length decreases when the expandable medical device expands due to frame shortening. This reduction in the longitudinal length of the expandable medical device causes the fractured portions of the fractured bone to pull together, thereby improving fracture repair.

[0099] Now for reference Figures 5A to 5D This paper demonstrates a non-limiting method for repairing a fractured bone B using an expandable medical device 100. Figure 5A The fractured bone B includes fracture zone F. The fractured bone F includes the intramedullary cavity IC, which contains bone marrow BM and other tissues and / or blood vessels. Reference now. Figure 5A A channel C has already formed in one end of the fractured bone B. The diameter of the channel can be as small as 2 mm and is typically 3 to 6 mm (and all values ​​and ranges in between). After the formation of channel C, as... Figure 5B As demonstrated, some or all of the bone marrow bone marrow (BM) and other tissues and / or blood vessels in the intramedullary intravascular coagulation (IC) can be temporarily removed. The procedures for removing the bone marrow bone marrow (BM) and other tissues and / or blood vessels in the intramedullary IC are known in the art and will not be described here.

[0100] Now for reference Figure 5COnce the bone marrow (BM) and other tissues and / or blood vessels in the intramedullary cavity (IC) have been adequately removed, an insertion tool IT is used to facilitate the insertion of the expandable medical device 100 into the IC. The insertion tool IT may optionally include the use of a sheath S and / or a guidewire GW to facilitate the insertion of the expandable medical device 100 into the IC. The sheath is shown inserted into a channel C. The sheath S may optionally be formed of an expandable material that expands as the expandable medical device 100 moves through the internal channel of the sheath and into the IC. The sheath S may be formed of a flexible polymer material. The sheath S may optionally include a shape memory material that causes the sheath to return to its original shape or near its original shape when or after the expandable medical device 100 has passed through the internal channel of the sheath. The sheath S is configured to inhibit or prevent damage to the bone marrow surrounding the channel C when the expandable medical device 100 passes through the channel C in a curled or unexpanded state. The sheath S is also configured to inhibit or prevent damage to the bone marrow surrounding the channel C as the expandable medical device 100 passes through the channel C (e.g., the tip of the expandable medical device becomes stuck in the bone marrow surrounding the channel, thereby bending or otherwise damaging the expandable medical device, etc.). Typically, no more than 50% (e.g., 0 to 50% and all values ​​and ranges therebetween) of the longitudinal length of the sheath S is inserted into a portion of the intramedullary cavity IC, where part or all of the bone marrow BM and other tissues and / or blood vessels in the intramedullary cavity IC have been removed. Figure 5C and Figure 5D As shown, the proximal end of the sheath S is partially spaced from the intramedullary cavity IC, in which part or all of the bone marrow BM and other tissues and / or blood vessels in the intramedullary cavity IC have been removed; however, this is not necessary.

[0101] The insertion tool IT may optionally include the use of a guidewire GW to facilitate the insertion of the expandable medical device 100 into the intramedullary vascular cavity (IC). The guidewire GW is shown inserted through channel C into a portion of the IC in which part or all of the bone marrow BM and other tissues and / or blood vessels in the IC have been removed. If a sheath S is used, the guidewire GW is inserted through an internal channel of the sheath S. As shown in Figure 5S, the guidewire GW extends to at least 50% (e.g., 50% to 100% and all values ​​and ranges therebetween) of the longitudinal length of the portion of the IC in which part or all of the bone marrow BM and other tissues and / or blood vessels in the IC have been removed.

[0102] After positioning the optional sheath S and guidewire GW within the fractured bone B, the expandable medical device 100 is inserted into a portion of the intramedullary cavity IC in its coiled or undilated state, where part or all of the bone marrow BM and other tissues and / or blood vessels within the intramedullary cavity IC have been removed. When using the sheath S, the expandable medical device 100 is fully inserted through the internal channel of the sheath S. When using the guidewire GW, the expandable medical device 100 is inserted around the guidewire GW and then guided along the guidewire into the intramedullary cavity IC until the expandable medical device 100 is correctly positioned within the intramedullary cavity IC. Typically, the intramedullary cavity IC is not inserted beyond the end of the guidewire GW until the expandable medical device 100 dilates within the intramedullary cavity IC.

[0103] Once the expandable medical device 100 is positioned within the intramedullary cavity IC, at least a portion of the frame or body of the expandable medical device 100 expands from a coiled state to an expanded state within the intramedullary cavity IC. For example... Figure 5D As shown, the posterior portion 102 and anterior portion 104 of the expandable medical device 100 expand within the intramedullary cavity IC. This expansion of the posterior portion 102 and anterior portion 104 of the expandable medical device 100 within the intramedullary cavity IC results in the posterior portion 102 of the expandable medical device 100 being anchored in one segment of the fractured bone B, and the anterior portion 104 of the expandable medical device 100 being anchored in another segment of the fractured bone B. Once the posterior portion 102 and anterior portion 104 of the expandable medical device 100 are properly anchored within the intramedullary cavity IC, the expandable medical device 100 can optionally be further expanded within the intramedullary cavity IC. Further expansion of the expandable medical device 100 may occur at the posterior portion 102 and anterior portion 104 of the expandable medical device 100, and / or in the middle portion 106 of the expandable medical device 100. The expansion of the rear portion 102 and the front portion 104 of the expandable medical device 100 can be simultaneous or sequential (e.g., the rear portion expands partially or completely before the front portion expands partially or completely, the front portion expands partially or completely before the rear portion expands partially or completely, etc.). After the rear portion 102 and the front portion 104 of the expandable medical device 100 have fully expanded, the intermediate portion 106 can optionally expand.

[0104] The frame or body of the expandable medical device 100 may be configured such that the longitudinal length of the expandable medical device shortens when it expands from a rolled-up state to an expanded state. Referring now to Figures 6A and 6B, a non-limiting configuration of the frame or body of the expandable medical device 100 is shown, which is configured to shorten upon expansion. The frame or body has an open-cell configuration and is formed by a plurality of interconnecting pillars and / or piles. The interconnecting pillars and / or piles may be configured to form various patterns (e.g., zigzag patterns, sawtooth patterns, triangular patterns, polygonal patterns, elliptical patterns, etc.). One or more of the interconnecting pillars and / or piles may have the same or different thicknesses and / or cross-sectional shapes and / or cross-sectional areas. Figure 6A shows the expandable medical device 100 in a rolled-up or expanded state. Figure 6B shows the expandable medical device 100 in an expanded state. The longitudinal length of the expandable medical device 100 in the expanded state is shown to be less than the longitudinal length of the expandable medical device 100 in the rolled-up or unexpanded state. In one non-limiting embodiment, the longitudinal length of the expandable medical device 100 in its expanded state is at least 5% smaller than the longitudinal length of the expandable medical device 100 in its coiled or unexpanded state (e.g., 5% to 60% and all values ​​and ranges therebetween). An inflation device (e.g., an expandable balloon, etc.) may be used to expand the expandable medical device 100.

[0105] Now for reference Figure 5C and Figure 5D When the expandable medical device 100 expands and the longitudinal length of the expandable medical device 100 decreases, the decrease in the longitudinal length of the expandable medical device 100 causes the fractured parts of the fractured bone B to be pulled together, thereby facilitating the repair of the fractured bone B.

[0106] The frame or body of the expandable medical device 100 is typically formed, in part or in whole, of a) a refractory metal alloy and / or b) a metal alloy containing at least 5 atomic weight percent (atomic weight %) or atomic weight percent (atomic weight %) rhenium (e.g., 5 to 99 atomic weight % rhenium and all values ​​and ranges therebetween). The frame or body of the expandable medical device 100 may also be formed, in part or in whole, of a metal alloy that does not contain chromium and / or nickel. In a non-limiting embodiment, the frame or body of the expandable medical device 100 may be formed, in part or in whole, of a metal alloy comprising at least 5 atomic weight percent (e.g., 5 to 99 atomic weight percent and all values ​​and ranges therein) of rhenium and 0.1 to 96 wt percent of one or more additives selected from the group consisting of: aluminum, boron, beryllium, bismuth, cadmium, calcium, cerium, chromium, cobalt, copper, gallium, gold, hafnium, iridium, iron, lanthanum, lanthanum oxide, lead, lithium, magnesium, manganese, molybdenum, nickel, niobium, osmium, palladium, platinum, rare earth metals, rhodium, ruthenium, scandium, silver, silicon, tantalum, technetium, tin, titanium, tungsten, vanadium, yttrium, zinc and / or zirconium, and the metal alloy optionally comprising 0 to 2 wt percent of other metals (e.g., metals other than additives), carbon, oxygen, phosphorus, sulfur, hydrogen and / or nitrogen.

[0107] The frame or body of the expandable medical device 100 may optionally be entirely or partially coated with a reinforcing coating. Non-limiting reinforcing coatings that may be applied to part or all of the expandable medical device include chromium nitride (CrN), diamond-like carbon (DLC), titanium nitride (TiN), titanium oxynitride (TiNOx), zirconium nitride (ZrN), zirconium oxide (ZrO2), zirconium-nitrogen-carbon (ZrNC), zirconium oxycarbonate (ZrOC), zirconium oxynitride (ZnNxOy) [e.g., cubic ZrN:O, cubic ZrO2:N, tetragonal ZrO2:N, and monoclinic ZrO2:N phase coatings] and combinations of such coatings. In another non-limiting embodiment, the thickness of the reinforcing coating is greater than 1 nanometer (e.g., 2 nanometers to 100 micrometers and all values ​​and ranges therebetween). In one non-limiting configuration, 50% to 100% (and all values ​​and ranges therebetween) of the outer surface of the frame or body of the expandable medical device 100 is coated with titanium oxynitride (TiNOx) and / or zirconium oxynitride (ZnNxOy).

[0108] Refer again Figure 5C and Figure 5DAfter the expandable medical device 100 expands within the intramedullary intramedullary intracranial IC, a portion of all removed bone marrow (RBM) removed from the intramedullary intracranial IC can optionally be reinserted into the intramedullary intracranial IC via an insertion device (e.g., a syringe, etc.). Furthermore, once the expandable medical device 100 is correctly positioned and expanded within the intramedullary intracranial IC of the fractured bone B, fixation and stabilization of the expandable medical device 100 within the intramedullary intracranial IC can optionally be achieved using cement, adhesive, or other surgical fluids. When used, cement, adhesive, or other surgical fluids can be inserted into the intramedullary intracranial IC before, during, or after the optional insertion of the removed bone marrow (RBM) into the intramedullary intracranial IC. Typically, when used, a guidewire (GW) is partially or completely removed from the intramedullary intracranial IC before the optional insertion of cement, adhesive, or other surgical fluids and / or the removed bone marrow (RBM) into the intramedullary intracranial IC. Before, during, or after the expandable medical device 100 is fully expanded in the intramedullary cavity IC, and / or optionally before, during, or after the insertion of cement, adhesive, or other surgical fluid and / or removed bone marrow (RBM) into the intramedullary cavity IC, the sheath S is removed from the intramedullary cavity IC. After the insertion tool IT is removed from the channel C, after the expandable medical device 100 is fully expanded in the intramedullary cavity IC, and after optionally the insertion of cement, adhesive, or other surgical fluid and / or removed bone marrow (RBM) into the intramedullary cavity IC, the channel C may optionally be sealed with a sealing material (e.g., cement, adhesive, or other surgical fluid, bone fragments, etc.).

[0109] Referring now to Figures 7A to 7D, the following figures are shown. Figures 5A to 5D The modified process of bone repair shown in the figure. The modified process includes the above-mentioned... Figures 5A to 5D The discussion covers the process, but includes the use of the second expandable medical device 200. The second expandable medical device 200 may optionally be inserted into the interior of the first expandable medical device 100 to increase the strength and / or stiffness of the expandable medical device system at the fracture site F of the fractured bone B. For example, the first expandable medical device 100 may be inserted into and expand within the intramedullary cavity IC, as described above. Figures 5A to 5D The discussion then continues. A second expandable medical device 200 may then be inserted into the expanded first expandable medical device 200. Typically, the longitudinal length of the expanded second expandable medical device 200 is less than the longitudinal length of the expanded first expandable medical device 200 (e.g., less by 20% to 80% and all values ​​and ranges therein).

[0110] Typically, the longitudinal length of the unexpanded second expandable medical device 200 is equal to or less than the longitudinal length of the unexpanded first expandable medical device 200 (e.g., less than 20% to 80% and all values ​​and ranges therebetween). In one non-limiting configuration, the longitudinal length of the unexpanded second expandable medical device 200 is less than the longitudinal length of the unexpanded first expandable medical device 200, such that when the unexpanded second expandable medical device 200 is inserted into the expanded first expandable medical device 100, the ends of the unexpanded second expandable medical device 200 are spaced inwardly from the ends of the expanded first expandable medical device 100. In another non-limiting configuration, when the first expandable medical device 100 and the second expandable medical device 200 expand, the ends of the expanded second expandable medical device 200 are spaced inwardly from the ends of the expanded first expandable medical device 100.

[0111] As shown in Figure 7D, the expanding second expandable medical device 200 extends across the length of the fracture site. Typically, 10% to 70% of the longitudinal length (and all values ​​and ranges therebetween) of one side of the expanding second expandable medical device 200 lies on one side of the fracture site F, and 10% to 70% of the longitudinal length (and all values ​​and ranges therebetween) of the other side of the expanding second expandable medical device 200 lies on the other side of the fracture site F. As shown in Figure 7C, the second expandable medical device 200 is inserted into the interior of the first expanding second expandable medical device 100 before expansion. The second expandable medical device 200 may be configured to a) shorten upon expansion, such that the longitudinal length of the expanded second expandable medical device is at least 10% smaller than the longitudinal length of the coiled or unexpanded second expandable medical device 200 (e.g., 10% to 60% smaller and all values ​​and ranges therebetween), or b) not shorten or substantially not shorten upon expansion, such that the longitudinal length of the expanded second expandable medical device is no more than 10% smaller than the longitudinal length of the coiled or unexpanded second expandable medical device 200 (e.g., 0% to 10% smaller and all values ​​and ranges therebetween). When the expanded second expandable medical device 200 is configured to shorten, the reduced longitudinal length of the expanded second expandable medical device 200 may facilitate further pulling the fractured portions of the fractured bone B together. The use of the expanded second expandable medical device 200 increases the rigidity and / or strength in the regions of the two expanded expandable medical devices 100, 200, in order to provide additional support to the fractured region of the fractured bone B. The materials used to form the first expandable medical device 100 and the second expandable medical device 200 may be the same or different. One or both of the first expandable medical device 100 and the second expandable medical device 200 may include a reinforcing coating and / or a biological agent.

[0112] After the second expandable medical device 200 has been expanded, a portion of all removed bone marrow (RBM) removed from the intramedullary intramedullary IC can optionally be reinserted into the intramedullary intramedullary IC via an insertion device (e.g., a syringe, etc.). Furthermore, once the expandable medical devices 100, 200 are correctly positioned and expanded within the intramedullary intramedullary IC of the fractured bone B, fixation and stabilization of the expandable medical devices 100, 200 within the intramedullary intramedullary IC can optionally be achieved using cement, adhesive, or other surgical fluids. When in use, cement, adhesive, or other surgical fluids can be inserted into the intramedullary intramedullary IC before, during, or after the optional insertion of the removed bone marrow (RBM) into the intramedullary intramedullary IC. Typically, when in use, a guidewire (GW) is partially or completely removed from the intramedullary intramedullary IC before the optional insertion of cement, adhesive, or other surgical fluids and / or the removed bone marrow (RBM) into the intramedullary intramedullary IC. Before, during, or after the expandable medical devices 100, 200 are fully expanded in the intramedullary cavity IC, and / or optionally before, during, or after the insertion of cement, adhesive, or other surgical fluid and / or removed bone marrow (RBM) into the intramedullary cavity IC, the sheath S is removed from the intramedullary cavity IC. After the insertion tool IT is removed from the channel C, after the expandable medical devices 100, 200 are fully expanded in the intramedullary cavity IC, and after optionally the insertion of cement, adhesive, or other surgical fluid and / or removed bone marrow (RBM) into the intramedullary cavity IC, the channel C may optionally be sealed with a sealing material (e.g., cement, adhesive, or other surgical fluid, bone fragments, etc.).

[0113] Now for reference Figure 8 This demonstrates several different non-restrictive fractures of bone B that can be repaired using one or two expandable medical devices according to this disclosure.

[0114] Therefore, it will be found that the purposes set forth above and those that become clear from the foregoing description are effectively achieved, and since certain changes can be made to the described construction without departing from the spirit and scope of this disclosure, it is intended that all subject matter contained in the foregoing description and shown in the accompanying drawings should be interpreted as illustrative and not restrictive. This disclosure has been described with reference to preferred and alternative embodiments. Modifications and variations will become apparent to those skilled in the art upon reading and understanding the detailed discussion of this disclosure provided herein. This disclosure is intended to include all such modifications and variations, provided they fall within the scope of this disclosure. It should also be understood that the following claims are intended to cover all general and specific features of this disclosure described herein, as well as all statements of scope of this disclosure, which may fall within the scope according to the language.

[0115] In order to assist the Patent Office and any reader of this application and any resulting patent in interpreting the appended claims, the applicant does not intend for any appended claim or claim element to invoke 35 USC 112(f) unless the words “means for…” or “steps for…” are expressly used in a particular claim.

Claims

1. An expandable device for treating a fracture site in a bone with an intramedullary cavity; the expandable device comprising an expandable frame; the expandable frame having an unexpanded shape and size such that the expandable frame can be inserted into the intramedullary cavity; the expandable frame having an expanded shape and size such that the expandable frame can be fixed in the intramedullary cavity while traversing the fracture site of the fractured bone; the expandable frame having a longitudinal length sufficient to completely span the fracture site; the expandable frame being capable of expanding to a second cross-sectional size in an expanded state from a first cross-sectional size in an unexpanded state; the cross-sectional area of ​​the expandable frame in the second cross-sectional size being greater than that of the expandable frame in the first cross-sectional size. The cross-sectional area of ​​the expandable frame in the unexpanded state is greater than the longitudinal length of the expandable frame in the expanded state; the expandable frame has sidewalls, the sidewalls including one or more openings; the expandable frame is formed at least partially from a metal alloy comprising at least 5 atomic weight percent rhenium and an additive material; the additive material comprises one or more metals selected from the group consisting of: aluminum, boron, beryllium, bismuth, cadmium, calcium, cerium, chromium, cobalt, copper, gallium, gold, hafnium, iridium, iron, lanthanum, lithium, magnesium, manganese, molybdenum, nickel, niobium, osmium, palladium, platinum, rare earth metals, rhodium, ruthenium, scandium, silver, silicon, tantalum, technetium, tin, titanium, tungsten, vanadium, yttrium, zinc, and zirconium; the rhenium and the additive material constitute at least 90% by weight of the rhenium alloy.

2. The expandable device of claim 1, wherein the rhenium alloy comprises 0 to 2% by weight of a combination of other metals, carbon, oxygen, phosphorus, sulfur, hydrogen, and nitrogen; wherein the other metals are metals other than the rhenium and the additive materials.

3. The expandable device of claim 1, wherein the expandable frame is at least partially coated with a biocompatible material; the biocompatible material includes a) a biological agent, b) titanium oxide nitride (TiNO₃). x c) Titanium nitride (TiN) coating, d) Chromium nitride (CrN) coating, e) Diamond-like carbon (DLC) coating, f) Zirconium nitride (ZrN) coating, g) Zirconium oxide (ZrO2) coating, h) Zirconium-nitrogen-carbon (ZrNC) coating, i) Zirconium oxycarbide (ZrOC) coating and / or j) Zirconium oxynitride (ZrN) coating x O y )coating.

4. The expandable device according to claim 2, wherein the expandable frame is at least partially coated with a biocompatible material; the biocompatible material includes a) a biological agent, b) a titanium oxide nitride (TiNOx) coating, c) a titanium nitride (TiN) coating, d) a chromium nitride (CrN) coating, e) a diamond-like carbon (DLC) coating, f) a zirconium nitride (ZrN) coating, g) a zirconium oxide (ZrO2) coating, h) a zirconium-nitrogen-carbon (ZrNC) coating, i) a zirconium oxycarbonate (ZrOC) coating and / or j) a zirconium oxynitride (ZrNxOy) coating.

5. The expandable device of claim 1, wherein the expandable frame is at least partially coated with a biocompatible material; the biocompatible material includes a) a biological agent, b) a titanium oxide nitride (TiNOx) coating and / or c) a zirconium oxynitride (ZrNxOy) coating.

6. The expandable device according to any one of claims 2 to 4, wherein the expandable frame is at least partially coated with a biocompatible material; the biocompatible material includes a) a biological agent, b) a titanium oxide nitride (TiNOx) coating and / or c) a zirconium oxynitride (ZrNxOy) coating.

7. The expandable device according to claim 5, wherein the biocompatible material comprises a) titanium oxide nitride (TiNO₃). x a) Coating and / or b) Zirconium oxynitride (ZrN) x O y )coating.

8. The expandable device according to claim 6, wherein the biocompatible material comprises a) a titanium oxide nitride (TiNOx) coating and / or b) a zirconium oxynitride (ZrNxOy) coating.

9. The expandable device of claim 1, wherein the expandable frame has a generally hollow tubular shape.

10. The expandable device according to any one of claims 2 to 8, wherein the expandable frame has a generally hollow tubular shape.

11. A method for repairing fractured bone, the method comprising: Provided fractured bone, the fractured bone comprising a first bone portion and a second bone portion and a fracture site located between the first bone portion and the second bone portion; the fracture site having a fracture site width; each of the first bone portion and the second bone portion of the fractured bone includes an intramedullary cavity; An expandable device is provided; the expandable device includes an expandable frame; the expandable frame has an unexpanded shape and size such that it can be inserted into the intramedullary cavity; the expandable frame has an expanded shape and size such that it can be fixed in the intramedullary cavity while traversing the fracture site of the fractured bone; the expandable frame has a longitudinal length sufficient to completely span the fracture site; the expandable frame is capable of expanding to a second cross-sectional size in an expanded state from a first cross-sectional size in an unexpanded state; the cross-sectional area of ​​the expandable frame in the second cross-sectional size is greater than the cross-sectional area of ​​the expandable frame in the first cross-sectional size; the expandable... The longitudinal length of the tension frame in the unexpanded state is greater than the longitudinal length of the expandable frame in the expanded state; the expandable frame has sidewalls, the sidewalls including one or more openings; the expandable frame is at least partially formed of a metal alloy comprising at least 5 atomic weight percent rhenium and an additive material; the additive material comprises one or more metals selected from the group consisting of: aluminum, boron, beryllium, bismuth, cadmium, calcium, cerium, chromium, cobalt, copper, gallium, gold, hafnium, iridium, iron, lanthanum, lithium, magnesium, manganese, molybdenum, nickel, niobium, osmium, palladium, platinum, rare earth metals, rhodium, ruthenium, scandium, silver, silicon, tantalum, technetium, tin, titanium, tungsten, vanadium, yttrium, zinc, and zirconium; the rhenium and the additive material constitute at least 90% by weight of the rhenium alloy. When the expandable device is in the unexpanded state, the expandable device is inserted into the intramedullary cavity such that at least a portion of the expandable device is positioned in the first bone portion and the second bone portion and traverses the fracture site; as well as The expandable device is expanded to the expanded state within the intramedullary cavity to repair the fractured bone; and The expansion of the expandable device causes the width of the fracture site to decrease as a result of the expansion of the first and second bone portions.

12. The method of claim 11, wherein the expandable device comprises a proximal portion, a distal portion, and an intermediate portion; and wherein the expansion step comprises expanding the proximal portion and / or the distal portion of the expandable device prior to expanding the intermediate portion; and wherein the pre-expansion of the proximal portion and / or the distal portion results in the proximal portion and / or the distal portion being at least partially anchored in the intramedullary cavity prior to the expansion of the intermediate portion.

13. The method of claim 11, wherein the expandable device comprises a proximal portion, a distal portion, and an intermediate portion; and the method further comprises the step of securing the proximal portion and / or the distal portion in the intramedullary cavity by: a) inserting one or more screws or posts into the fractured bone to restrict movement of the proximal portion and / or the distal portion in the intramedullary cavity, and / or b) inserting adhesive and / or cement into the intramedullary cavity to restrict movement of the proximal portion and / or the distal portion in the intramedullary cavity.

14. The method of claim 12, wherein the expandable device comprises a proximal portion, a distal portion, and an intermediate portion; and the method further comprises the step of securing the proximal portion and / or the distal portion in the intramedullary cavity by: a) inserting one or more screws or posts into the fractured bone to restrict movement of the proximal portion and / or the distal portion in the intramedullary cavity, and / or b) inserting adhesive and / or cement into the intramedullary cavity to restrict movement of the proximal portion and / or the distal portion in the intramedullary cavity.

15. The method of claim 11, further comprising the following steps: a) removing at least a portion of the bone marrow from the intramedullary cavity before inserting the expandable device into the intramedullary cavity; and b) after the step of expanding the expandable device in the intramedullary cavity, inserting at least a portion of the removed bone marrow into the intramedullary cavity.

16. The method according to any one of claims 12 to 14, further comprising the following steps: a) removing at least a portion of the bone marrow from the intramedullary cavity before inserting the expandable device into the intramedullary cavity; and b) after the step of expanding the expandable device in the intramedullary cavity, inserting at least a portion of the removed bone marrow into the intramedullary cavity.

17. The method of claim 11, wherein the rhenium alloy comprises 0 to 2% by weight of a combination of other metals, carbon, oxygen, phosphorus, sulfur, hydrogen, and nitrogen; wherein the other metals are metals other than the rhenium and the additive material.

18. The method according to any one of claims 12 to 16, wherein the rhenium alloy comprises 0 to 2% by weight of a combination of other metals, carbon, oxygen, phosphorus, sulfur, hydrogen, and nitrogen; wherein the other metals are metals other than the rhenium and the additive materials.

19. The method of claim 11, wherein the expandable frame is at least partially coated with a biocompatible material; the biocompatible material comprises a) a biological agent, b) titanium oxide nitride (TiNO₃). x c) Titanium nitride (TiN) coating, d) Chromium nitride (CrN) coating, e) Diamond-like carbon (DLC) coating, f) Zirconium nitride (ZrN) coating, g) Zirconium oxide (ZrO2) coating, h) Zirconium-nitrogen-carbon (ZrNC) coating, i) Zirconium oxycarbide (ZrOC) coating and / or j) Zirconium oxynitride (ZrN) coating x O y )coating.

20. The method according to any one of claims 12 to 18, wherein the expandable frame is at least partially coated with a biocompatible material; said biocompatible material includes a) a biological agent, b) a titanium oxide nitride (TiNOx) coating, c) a titanium nitride (TiN) coating, d) a chromium nitride (CrN) coating, e) a diamond-like carbon (DLC) coating, f) a zirconium nitride (ZrN) coating, g) a zirconium oxide (ZrO2) coating, h) a zirconium-nitrogen-carbon (ZrNC) coating, i) a zirconium oxycarbide (ZrOC) coating and / or j) a zirconium oxynitride (ZrNxOy) coating.

21. The method of claim 19, wherein the biocompatible material comprises a) a titanium oxide nitride (TiNOx) coating and / or b) a zirconium oxynitride (ZrNxOy) coating.

22. The method of claim 20, wherein the biocompatible material comprises a) a titanium oxide nitride (TiNOx) coating and / or b) a zirconium oxynitride (ZrNxOy) coating.

23. The method of claim 11, wherein the expandable frame has a generally hollow tubular shape.

24. The method according to any one of claims 12 to 22, wherein the expandable frame has a generally hollow tubular shape.

25. The method of claim 11, further comprising the following steps: A sheath is used to facilitate insertion of the expandable device into the intramedullary cavity; the sheath includes a tubular structure having a longitudinal cavity; the longitudinal cavity has dimensions and shape configured such that the expandable device in the unexpanded state can move through the longitudinal cavity; at least a portion of the sheath is optionally formed of an elastic material.

26. The method according to any one of claims 12 to 24, further comprising the following steps: A sheath is used to facilitate insertion of the expandable device into the intramedullary cavity; the sheath includes a tubular structure having a longitudinal cavity; the longitudinal cavity has dimensions and shape configured such that the expandable device in the unexpanded state can move through the longitudinal cavity; at least a portion of the sheath is optionally formed of an elastic material.

27. The method of claim 11, further comprising the following steps: A guidewire is used to facilitate the insertion of a portion of the expandable device into the intramedullary cavity; The guidewire has sufficient flexibility and rigidity to allow the expandable device in the unexpanded state to pass through the intramedullary cavity and move along the guidewire.

28. The method according to any one of claims 12 to 26, further comprising the following steps: A guidewire is used to facilitate the insertion of a portion of the expandable device into the intramedullary cavity; The guidewire has sufficient flexibility and rigidity to allow the expandable device in the unexpanded state to pass through the intramedullary cavity and move along the guidewire.

29. The method of claim 11, further comprising the following steps: A second expandable device is provided; the second expandable device includes a second expandable frame having an open-cell configuration; the second expandable frame includes a plurality of interconnected struts; when the second expandable frame is oriented in an unexpanded shape and size, the second expandable device is able to be inserted into the intramedullary cavity; The expandable frame is configured to expand to an expanded shape and size; the second expandable frame has a longitudinal length sufficient to completely span the fracture site; the second expandable frame is capable of expanding to a second cross-sectional size from a first cross-sectional size in its unexpanded state; the cross-sectional area of ​​the second expandable frame at the second cross-sectional size is greater than the cross-sectional area of ​​the second expandable frame at the first cross-sectional size; the longitudinal length of the second expandable frame in its unexpanded state is greater than the longitudinal length of the second expandable frame in its expanded state; the second expandable frame has sidewalls including a plurality of openings; The second expandable frame is at least partially formed of a metal alloy comprising at least 5 atomic weight percent rhenium and an additive material; the additive material comprises one or more metals selected from the group consisting of: aluminum, boron, beryllium, bismuth, cadmium, calcium, cerium, chromium, cobalt, copper, gallium, gold, hafnium, iridium, iron, lanthanum, lithium, magnesium, manganese, molybdenum, nickel, niobium, osmium, palladium, platinum, rare earth metals, rhodium, ruthenium, scandium, silver, silicon, tantalum, technetium, tin, titanium, tungsten, vanadium, yttrium, zinc, and zirconium; the rhenium and the additive material constitute at least 90% by weight of the rhenium alloy. Insert the second expandable device into the interior of the expanded expandable device; as well as The second expandable device is expanded inside the expandable device to increase the strength and / or stiffness around the fracture area.

30. The method according to any one of claims 12 to 28, further comprising the following steps: A second expandable device is provided; the second expandable device includes a second expandable frame having at least one opening; when the second expandable frame is oriented in an unexpanded shape and size, the second expandable device is able to be inserted into the intramedullary cavity; The expandable frame is configured to expand to an expanded shape and size; the second expandable frame has a longitudinal length sufficient to completely span the fracture site; the second expandable frame is capable of expanding to a second cross-sectional size from a first cross-sectional size in its unexpanded state; the cross-sectional area of ​​the second expandable frame at the second cross-sectional size is greater than the cross-sectional area of ​​the second expandable frame at the first cross-sectional size; the longitudinal length of the second expandable frame in its unexpanded state is greater than the longitudinal length of the second expandable frame in its expanded state; the second expandable frame has sidewalls including a plurality of openings; The second expandable frame is at least partially formed of a metal alloy comprising at least 5 atomic weight percent rhenium and an additive material; the additive material comprises one or more metals selected from the group consisting of: aluminum, boron, beryllium, bismuth, cadmium, calcium, cerium, chromium, cobalt, copper, gallium, gold, hafnium, iridium, iron, lanthanum, lithium, magnesium, manganese, molybdenum, nickel, niobium, osmium, palladium, platinum, rare earth metals, rhodium, ruthenium, scandium, silver, silicon, tantalum, technetium, tin, titanium, tungsten, vanadium, yttrium, zinc, and zirconium; the rhenium and the additive material constitute at least 90% by weight of the rhenium alloy. Insert the second expandable device into the interior of the expanded expandable device; as well as The second expandable device is expanded inside the expandable device to increase the strength and / or stiffness around the fracture area.

31. The method of claim 29, wherein the longitudinal length of the second expandable device in the expanded state is less than the longitudinal length of the expanded expandable device.

32. The method of claim 30, wherein the longitudinal length of the second expandable device in the expanded state is less than the longitudinal length of the expanded expandable device.

33. The method of claim 29, wherein the second expandable device is configured to a) shorten upon expansion such that the longitudinal length of the expanded second expandable device is at least 10% smaller than the longitudinal length of the second expandable device in its unexpanded state.

34. The method according to any one of claims 30 to 32, wherein the second expandable device is configured to a) shorten upon expansion such that the longitudinal length of the expanded second expandable device is at least 10% smaller than the longitudinal length of the second expandable device in its unexpanded state.

35. The method of claim 29, wherein when the second expandable device expands within the expandable device, the end of the second expandable device does not extend beyond the end of the expandable device in the expanded state.

36. The method according to any one of claims 30 to 34, wherein when the second expandable device expands within the expandable device, the end of the second expandable device does not extend beyond the end of the expandable device in the expanded state.

37. The method of claim 29, wherein the second expandable frame is at least partially coated with a biocompatible material; the biocompatible material includes a) a biological agent, b) titanium oxide nitride (TiNO₃). x c) Titanium nitride (TiN) coating, d) Chromium nitride (CrN) coating, e) Diamond-like carbon (DLC) coating, f) Zirconium nitride (ZrN) coating, g) Zirconium oxide (ZrO2) coating, h) Zirconium-nitrogen-carbon (ZrNC) coating, i) Zirconium oxycarbide (ZrOC) coating and / or j) Zirconium oxynitride (ZrN) coating x O y )coating.

38. The method according to any one of claims 30 to 36, wherein the second expandable frame is at least partially coated with a biocompatible material; the biocompatible material includes a) a biological agent, b) a titanium oxide nitride (TiNOx) coating, c) a titanium nitride (TiN) coating, d) a chromium nitride (CrN) coating, e) a diamond-like carbon (DLC) coating, f) a zirconium nitride (ZrN) coating, g) a zirconium oxide (ZrO2) coating, h) a zirconium-nitrogen-carbon (ZrNC) coating, i) a zirconium oxycarbonate (ZrOC) coating and / or j) a zirconium oxynitride (ZrNxOy) coating.

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