IMPROVED METAL ALLOYS FOR MEDICAL DEVICES

Abstract

A medical device and a method and process for at least partially forming a medical device, which medical device has improved physical properties. The one or more improved physical properties of the novel metal alloy can be achieved in the medical device without having to increase the bulk, volume and/or weight of the medical device.

Claims

1. A medical device that is at least partially formed of a metal alloy which improves the strength and ductility of the medical device, said metal alloy including at least about 55 wt. % of a solid solution of rhenium and molybdenum alloy, said metal alloy including at least about 20 wt. % rhenium and at least about 20 wt. % molybdenum, said metal alloy including about 0.01-35 wt. % of one or more additional metals selected from the group consisting of hafnium, niobium, osmium, platinum, technetium, titanium, tungsten, vanadium, and zirconium.

2. The medical device as defined in claim 1, wherein said metal alloy includes 0.0135 wt. % of one or more additional metals selected from the group consisting of hafnium, osmium, platinum, technetium and vanadium.

3. The medical device as defined in claim 1, wherein said metal alloy includes 0.0135 wt. % of two or more additional metals, one of said additional metals is selected from the group consisting of hafnium, osmium, platinum, technetium and vanadium, a second different additional metal is selected from the group consisting of hafnium, niobium, osmium, platinum, technetium, titanium, tungsten, vanadium, and zirconium.

4. The medical device as defined in claim 1, wherein said metal alloy has a controlled amount of nitrogen, oxygen and carbon so as to reduce micro-cracking in said metal alloy, a nitrogen content of said metal alloy less than a combined content of oxygen and carbon in said metal alloy, said metal alloy including an oxygen to nitrogen atomic ratio of at least about 1.2:1, said metal alloy including a carbon to nitrogen atomic ratio of at least about 2:1.

5-30. (canceled)

31. The medical device as defined in claim 1, wherein said metal alloy includes less than about 0.2 wt. % carbon, less than about 0.1 wt. % oxygen, and less than about 0.001 wt. % nitrogen.

32. The medical device as defined in claim 1, wherein said metal alloy includes at least 95 wt. % rhenium and molybdenum and less than about 5 wt. % of a metal selected from the group consisting of consisting of hafnium, niobium, osmium, platinum, technetium, titanium, tungsten, vanadium, and zirconium, or mixtures thereof.

33. The medical device as defined in claim 1, wherein said metal alloy has an average yield strength of at least about 70 ksi and an average ultimate tensile strength of at least about 60 ksi, said metal alloy having an average grain size is about 5-10 ASTM, said metal alloy having an average tensile elongation of at least about 25%, said metal alloy having an average hardness of at least about 60 Rockwell A Hardness at 77° F., and said metal alloy having an average density of at least about 13.4 gm/cc.

34. The medical device as defined in claim 1, wherein said metal alloy has a nitrogen content of less than about 0.001 wt. %, said metal alloy having a carbon content of less than about 0.2 wt. %, having an oxygen content of less than about 0.1 wt. %, said metal alloy including an oxygen to carbon atomic ratio of about 0.2:1 and up to about 50:1, said metal alloy including an oxygen to nitrogen atomic ratio of at least about 1.2:1 and up to about 100:1, said metal alloy including a carbon to nitrogen atomic ratio of at least about 2:1 and up to about 100:1.

35. The medical device as defined in claim 1, wherein said metal alloy includes about 45-50 wt. % rhenium and about 50-55 wt. % molybdenum.

36. The medical device as defined in claim 1, wherein at least one region of said medical device includes at least one biological agent.

37. The medical device as defined in claim 1, wherein at least one region of said medical device includes at least one polymer.

38. The medical device as defined in claim 37, wherein at least one region of said medical device includes at least one polymer, said at least one polymer at least partially coats, encapsulates or combinations thereof said at least one agent.

39. The medical device as defined in claim 1, wherein said medical device includes at least one micro-structure in an outer surface of said medical device.

40. The medical device as defined in claim 1, wherein said at least one microstructure is at least partially formed of, includes, or combinations thereof, a material consisting of a polymer, an agent, or combinations thereof.

41. A method for forming a medical device comprising the steps of: a) providing a metal alloy as defined in claim 1; and, b) forming said metal alloy into said medical device.

42. The method as defined in claim 41, wherein said metal alloy is in the form of a rod or tube, and further including the steps of: drawing down said outer cross-sectional area of said rod or tube by a reducing mechanism; annealing said rod or tube at an annealing temperature in an oxygen reducing environment or inert environment after said rod or tube has been drawn down; cooling said annealed rod or tube at a rate of at least about 100° C. per minute; drawing down said cross-sectional area of said rod or tube by the reducing mechanism after said rod or tube has been annealed; and, annealing said rod or tube at least one additional time at an annealing temperature that is lower temperature than at least one annealing temperature of a previous annealing of said rod or tube.

43. The method as defined in claim 41, wherein said step of annealing said rod or tube includes the steps of a) annealing the rod or tube at an annealing temperature of at least about 1480° C. for a time period of at least about five minutes when said rod or tube has wall thickness of greater than about 0.015 inch, b) annealing the rod or tube at an annealing temperature of about 1450-1480° C. for a time period of at least about five minutes when said rod or tube has wall thickness of about 0.008-0.015 inch, and c) annealing the rod or tube at an annealing temperature of less than about 1450° C. for a time period of at least about five minutes when said rod or tube has wall thickness of less than about 0.008 inch.

44. The method as defined in claim 41, including the step of coating said metal alloy with a second metal or metal alloy, said second metal or metal alloy having a melting temperature that is less than said coated metal alloy.

Description

[0073] One non-limiting object of the present invention is the provision of a medical device that is at least partially formed of a novel alloy.

[0074] Another and/or alternative non-limiting object of the present invention is the provision of a medical device having improved procedural success rates.

[0075] Yet another and/or alternative non-limiting object of the present invention is the provision of a method and process for forming a metal alloy that inhibits or prevents the formation of micro-cracks during the processing of the alloy into a medical device.

[0076] Still another and/or alternative non-limiting object of the present invention is the provision of a medical device that is formed of a material that improves the physical properties of the medical device.

[0077] Yet another and/or alternative non-limiting object of the present invention is the provision of a medical device that is at least partially formed of a novel alloy that has increased strength and can also be used as a marker material.

[0078] Still yet another and/or alternative non-limiting object of the present invention is the provision of a medical device that at least partially includes a novel alloy that enables the medical device to be formed with less material without sacrificing the strength of the medical device as compared to prior medical devices.

[0079] Still yet another and/or alternative non-limiting object of the present invention is the provision of a medical device that is simple and cost effective to manufacture.

[0080] A further and/or alternative non-limiting object of the present invention is the provision of a medical device that is at least partially coated with one or more polymer coatings.

[0081] Still a further and/or alternative non-limiting object of the present invention is the provision of a medical device that is coated with one or more biological agents.

[0082] Yet a further and/or alternative non-limiting object of the present invention is the provision of a medical device that has one or more polymer coatings to at least partially control the release rate of one or more biological agents.

[0083] Still yet a further and/or alternative non-limiting object of the present invention is the provision of a medical device that includes one or more surface structures and/or micro-structures.

[0084] Still a further and/or alternative non-limiting object of the present invention is the provision of a method and process for forming a novel alloy into a medical device.

[0085] Another and/or alternative non-limiting object of the present invention is the provision of a medical device that includes one or more surface structures, micro-structures and/or internal structures, and a protective coating that at least partially covers and/or protects such structures.

[0086] Yet another and/or alternative non-limiting object of the present invention is the provision of a medical device that includes one or more markers.

[0087] Still another and/or alternative non-limiting object of the present invention is the provision of a medical device that includes and/or is used with one or more physical hindrances.

[0088] Still yet another and/or alternative non-limiting object of the present invention is the provision of a medical device that can be used in conjunction with one or more biological agents not on or in the medical device.

[0089] A further and/or alternative non-limiting object of the present invention is the provision of a method and process for forming a novel alloy that inhibits or prevents the formation of micro-cracks during the processing of the alloy into a medical device.

[0090] Still a further and/or alternative non-limiting object of the present invention is the provision of a medical device that includes CNT.

[0091] Another and/or alternative non-limiting object of the present invention is the provision of a method and process for forming a novel alloy that inhibits or prevents in the introduction of impurities into the alloy during the processing of the alloy into a medical device.

[0092] Still another and/or alternative non-limiting object of the present invention is the provision of a method and process for forming a novel alloy that inhibits or prevents crack propagation and/or fatigue failure.

[0093] Yet another and/or alternative non-limiting object of the present invention is the provision of a medical device that is used in orthopedics (e.g., orthopedic device, nail, rod, screw, post, cage, plate, pedicle screw, cap, hinge, joint system, wire, anchor, spacer, shaft, spinal implant, anchor, disk, ball, tension band, locking connector, bone implant, prosthetic implant or device to repair, replace and/or support a bone; etc.), which medical device may or may not be expandable.

[0094] Yet another and/or alternative non-limiting object of the present invention is the provision of a medical device that is in the form of an implant for insertion into a body passageway (e.g., PFO device, stent, valve, spinal implant, vascular implant; graft, guide wire, sheath, stent catheter, electrophysiology catheter, hypotube, catheter, etc.), which medical device may or may not be expandable.

[0095] Still yet another and/or alternative non-limiting object of the present invention is the provision of a medical device that is used in dentistry and orthodontics (e.g., dental restorations, dental implants, crowns, bridges, braces, dentures, wire, anchors, spacers, retainers, tubes, pins, screws, posts, rods, plates, palatal expander, orthodontic headgear, orthodontic archwire, teeth aligners, quadhelix, etc.). One non-limiting medical device that is used in dentistry and orthodontics is in the form of a dental implant. The dental implant for insertion into bone generally includes an implant anchor having a connection arrangement (e.g., an interlocking thread, etc.). The dental implant can include a plurality of keys disposed about the distal end of the abutment, which distal end is capable of being affixed to the prosthetic tooth or dental appliance, and has an implantable anchor having a proximal and distal end, a plurality of female keyways defined into the proximal end of the anchor, the keyways capable of coupling to the male keys of the abutment and thereby preventing relative rotation of the abutment and anchor; however, this is not required. The dental implant can optionally include a repository bore perpendicular to the longitudinal bore defined in a distal portion of the anchor. The repository bore is cut through a portion of the anchor creating very sharp cutting edges to become self-tapping. The repository bore also can optionally serve as a repository for the bone chips created during the thread cutting process. One non-limiting dental implant is described in U.S. Pat. No. 7,198,488, which is incorporated herein by reference. The dental implant has a cylindrical anchoring head formed unitarily with a screw element. The screw element, usually made of the metal alloy of the present invention or titanium with a roughened surface, is to be screwed into the recipient jaw bone. The anchoring head which can be formed of the metal alloy of the present invention is adapted to have a prosthetic tooth mounted on it.

[0096] A further and/or alternative non-limiting object of the present invention is the provision of a method and process for forming a novel metal alloy that inhibits or prevents the introduction of impurities into the alloy during the processing of the alloy into a medical device.

[0097] Another and/or alternative non-limiting object of the present invention is the provision of a method and process of forming a medical device that includes a swaging process to harden the outer surface of the medical device.

[0098] Still another and/or alternative non-limiting object of the present invention is the provision of a method and process of forming a medical device that that includes a swaging process to form compounds of ReB2, ReN2 and/or ReN3 on the surface of the medical device.

[0099] Yet another and/or alternative non-limiting object of the present invention is the provision of a method and process of forming a medical device that includes a swaging process to form a medical device having a hard surface and a softer core.

[0100] Still yet another and/or alternative non-limiting object of the present invention is the provision of a method and process of forming a medical device that includes one metal or metal alloy coated with another metal or metal alloy and wherein the outer coating of the metal or metal alloy has a hardness at room temperature that is greater than the hardness of the coated metal or metal alloy.

[0101] Still yet another and/or alternative non-limiting object of the present invention is the provision of a method and process of forming a medical device that includes one metal or metal alloy coated with another metal or metal alloy and wherein the outer coating of the metal or metal alloy has a melting point that is less than the melting point of the coated metal or metal alloy.

[0102] These and other advantages will become apparent to those skilled in the art upon the reading and following of this description.

[0103] Other or additional features of the invention are disclosed in U.S. Pat. Nos. 7,488,444; 7,452,502; 7,540,994; 7,452,501; 8,398,916; U.S. application Ser. Nos. 12/373,380; 61/816,357; 61/959,260; 61/871,902; 61/881,499; and PCT Application Nos. PCT/US2013/045543 and PCT/US2013/062804, which are all incorporated by reference herein.

[0104] It will thus be seen that the objects set forth above, among those made apparent from the preceding description, are efficiently attained, and since certain changes may be made in the constructions set forth without departing from the spirit and scope of the invention, it is intended that all matter contained in the above description and shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense. The invention has been described with reference to preferred and alternate embodiments. Modifications and alterations will become apparent to those skilled in the art upon reading and understanding the detailed discussion of the invention provided herein. This invention is intended to include all such modifications and alterations insofar as they come within the scope of the present invention. It is also to be understood that the following claims are intended to cover all of the generic and specific features of the invention herein described and all statements of the scope of the invention, which, as a matter of language, might be said to fall therebetween.