HEAT TREATMENT OF A METAL ALLOY

Abstract

A medical device that includes special heat treated components and a method for heat treating the metal alloy for the medical device.

Claims

1. A metal rod that that is formed of a metal alloy and which metal rod is a medical device or forms a portion of a medical device; said metal rod has one or more physical properties that are different along a longitudinal length of said metal that selected from the group consisting of a) a different flexibility or bendability, b) a different yield strength, c) a different ultimate tensile strength, and d) a different metal alloy crystalline structure; said one or more different physical properties of said metal rod along said longitudinal length of said metal rod at least partially obtained by subjecting different portions of said metal rod to a different final heat treatment process; said different final heat treatment process includes I) subjecting said metal alloy to a different final heat temperature at different locations along said longitudinal length of said metal rod, II) exposing said metal alloy to said final heat temperature for different time periods at different locations along said longitudinal length of said metal rod; and/or III) cooling said metal rod after said final heat treatment process at different cooling rates at different locations along said longitudinal length of said metal rod.

2. The metal rod as defined in claim 1, wherein said metal alloy includes at least 15 awt. % rhenium.

3. The metal rod as defined in claim 1, wherein said metal rod has a constant cross-sectional shape and size along 80%-100% of said longitudinal length of said metal rod.

4. The metal rod as defined in claim 1, wherein at least a portion of said metal rod is not subjected to a quench process during said cooling of said metal rod.

5. A method for forming a metal rod that has different physical properties along a longitudinal length of said metal rod comprising the steps of: a) providing said metal rod; said metal rod is formed of a metal alloy; and b) subjecting different portions of said metal rod to a different final heat treatment process along a longitudinal length of said metal rod such that different portions of said metal rod at different longitudinal locations of said metal rod have one or more different physical properties selected from the group consisting of a) a different flexibility or bendability, b) a different yield strength, c) a different ultimate tensile strength, and d) a different metal alloy crystalline structure; said different final heat treatment process includes I) subjecting said metal alloy to a different final heat temperature at different locations along said longitudinal length of said metal rod, II) exposing said metal alloy to said final heat temperature for different time periods at different locations along said longitudinal length of said metal rod; and/or III) cooling said metal rod after said final heat treatment process at different cooling rates at different locations along said longitudinal length of said metal rod.

6. The method as defined in claim 5, wherein said metal alloy includes at least 15 awt. % rhenium.

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

8. The method as defined in claim 5, wherein at least a portion of said metal rod is not subjected to a quench process during said cooling of said metal rod.

9. The method as defined in claim 5, wherein said maximum temperature of said final heat treatment is 500-1000 C.

10. The method as defined in claim 5, wherein metal rod is subjected to said final heat treatment process for about 0.5-25 hours.

11. The method as defined in claim 5, wherein said step of cooling cools said metal rod at a rate of less than 100 C./s.

12. The method as defined in claim 5, wherein said step of subjecting said metal rod to a final heat treatment process includes a) initially increasing a temperature about said metal rod from a minimum temperature to maximum temperature for a first prior of time, and b) maintaining said maximum temperature about said metal rod for a second period of time.

13. The method as defined in claim 12, wherein said minimum temperature is 10-250 C.; said first period of time is 0.5-10 hours; said second period of time is 0.01-15 hours.

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

15. The method as defined in claim 5, further including the step of marking said metal rod to indicate a relatively degree of flexibility of said metal rod.

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

17. The set of spinal surgery materials as defined in claim 16, wherein said body portion of said first bone screw has a different shape, size and/or longitudinal length from said second bone screw; said first bone screw includes a first screw visual marking; said second bone screw includes a second screw visual marking; said first and second screw visual markings are different.

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

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

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

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

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

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

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

25. The method as defined in claim 24, wherein said final heat treatment process of one or both of said first and second metal rods is absent quenching of one or both of said first and second metal rods.

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

27. The method as defined in claim 24, wherein a maximum temperature of said final heat treatment or one or both of said first and second metal rods is 500-1000 C.

28. The method as defined in claim 24, wherein one or both of said first and second metal rods is subjected to said final heat treatment process for about 0.5-25 hours.

29. The method as defined in claim 24, wherein said step of subjecting said first metal rod to a final heat treatment process includes a) initially increasing a temperature about said first metal rod from a minimum temperature to maximum temperature for a first period of time, and b) maintaining said maximum temperature about said first metal rod for a second period of time; said step of subjecting said second metal rod to a final heat treatment process includes a) initially increasing a temperature about said second metal rod from a minimum temperature to maximum temperature for a first period of time, and b) maintaining said maximum temperature about said second metal rod for a second period of time.

30. The method as defined in claim 29, wherein said minimum temperature is 10-250 C. for one or both of said first and second metal rods; said first period of time is 0.5-10 hours for one or both of said first and second metal rods; said second period of time is 0.01-15 hours for one or both of said first and second metal rods; said first period of time and/or said second period of said for said first metal rod is different from said second metal rod.

31. The method as defined in claim 24, wherein one or both of said first and second metal rods is cooled during said step of cooling at a rate of less than 100 C./s.

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

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0151] Reference may now be made to the drawings, which illustrate various non-limiting embodiments that the disclosure may take in physical form and in certain parts and arrangement of parts wherein:

[0152] FIG. 1 illustration a non-limiting process for the final heating of a medical device.

[0153] FIG. 2 is a graph that illustrates the amount of recoil of several different metal alloys.

[0154] FIG. 3 is an illustration that compares the conformability of a metal strip or wire formed of the refractory metal alloy or the metal alloy that includes at least 15 awt. % rhenium to the shape of a die surface as compared to the conformity of a metal strip or wire of CoCr alloy on the same die surface.

[0155] FIGS. 4A-4C illustrate stress vs. reduction in percent area graphs of TiAlV alloy, CoCr alloy and MoRe alloy.

[0156] FIG. 5 is a graph that illustrates the differences of stiffness and yield strength of a MoRe alloy, CoCr alloy and TiAlV alloy.

[0157] FIGS. 6-8 are graphs that illustrate the strength and fatigue ductility of a TiAlV alloy, CoCr alloy and MoRe alloy.

[0158] FIG. 9 illustrates the hydrophilicity of a MoRe alloy, a CoCr alloy, and a TiAlV alloy.

[0159] FIGS. 10-11 illustrate the ion release rates of a refractory metal alloy or a metal alloy that includes at least 15 awt. % rhenium such as MoRe.

[0160] FIG. 12 illustrates the ion release rates in tissue from a MoRe alloy, a CoCr alloy, and a TiAlV alloy.

[0161] FIG. 13 is a Table that illustrated different final heat treat spinal rods and the force that was required to bend each of the spinal rods.

[0162] Although specific terms are used in the following description for the sake of clarity, these terms are intended to refer only to the particular structure of the embodiments selected for illustration in the drawings and are not intended to define or limit the scope of the disclosure. In the drawings and the following description below, it is to be understood that like numeric designations refer to components of like function.

[0163] The singular forms a, an, and the include plural referents unless the context clearly dictates otherwise.

[0164] As used in the specification and in the claims, the term comprising may include the embodiments consisting of and consisting essentially of. The terms comprise(s), include(s), having, has, can, contain(s), and variants thereof, as used herein, are intended to be open-ended transitional phrases, terms, or words that require the presence of the named ingredients/steps and permit the presence of other ingredients/steps. However, such description should be construed as also describing compositions or processes as consisting of and consisting essentially of the enumerated ingredients/steps, which allows the presence of only the named ingredients/steps, along with any unavoidable impurities that might result therefrom, and excludes other ingredients/steps.

[0165] Numerical values in the specification and claims of this application should be understood to include numerical values which are the same when reduced to the same number of significant figures and numerical values which differ from the stated value by less than the experimental error of conventional measurement technique of the type described in the present application to determine the value.

[0166] All ranges disclosed herein are inclusive of the recited endpoint and independently combinable (for example, the range of from 2 grams to 10 grams is inclusive of the endpoints, 2 grams and 10 grams, and all the intermediate values).

[0167] The terms about and approximately can be used to include any numerical value that can vary without changing the basic function of that value. When used with a range, about and approximately also disclose the range defined by the absolute values of the two endpoints, e.g., about 2 to about 4 also discloses the range from 2 to 4. Generally, the terms about and approximately may refer to plus or minus 10% of the indicated number.

[0168] Percentages of elements should be assumed to be percent by weight of the stated element, unless expressly stated otherwise.

[0169] The medical device in accordance with the present disclosure can be any medical device that can be inserted or otherwise applied to a patient. Non-limiting medical devices in accordance with the present disclosure include orthopedic devices, PFO devices, stents, valves (e.g., heart valve, etc.), spinal implants, devices for treating aneurysms, occlusive devices for use in blood vessels and other body passageways, flow adjusting and/or diversion devices for blood vessels, devices for de-endothelializing a wall of an aneurysm, frame and other structures for use with a spinal implants, vascular implant, graft, dental implant, wire for used in medical procedures, bone implant; artificial disk, artificial spinal disk, prosthetic implant or device to repair, replace and/or support a bone and/or cartilage, bone plate, nail; rod, screw, post; cage, plate, pedicle screw, joint system, anchor, bone spacer, or disk that is used in a body to support a structure, mount a structure, and/or repair a structure in a body such as, but not limited to, a human body, animal body, etc.

[0170] As discussed above, FIG. 1 illustrates a non-limiting process for subjecting a portion or all of a medical device to a final heating process so as to reduce the yield strength and/or ultimate tensile strength of the portion of the refractory metal alloy or the metal alloy that includes at least 15 awt. % rhenium that has been subjected to the final heating process. As illustrated in FIG. 1, the rod or post that is being subjected to the final heating is illustrated as being 20 inches; however, it will be appreciated that other rod or post lengths can be used. As also illustrated in FIG. 1, the bottom portion of the rod or post that is located in the heating oven is about 14 inches and the top portion of the rod or post located outside of the heating oven is about 6 inches; however, it can be appreciated that more of the rod or post or less of the rod or post can be positioned in the heating oven for a final heating process. In one non-limiting arrangement, the rod portion that is located in the heating oven is exposed to temperatures of up to 1000 C. (e.g., 100-1000 C. and all values and ranges therebetween). In one particular non-limiting arrangement, the rod portion that was located in the furnace was initially exposed to a temperature of 10-250 C. (and all values and ranges therebetween, 90-160 C.) (e.g., Preheat step), and then the heat was increased to 500-1000 C. (and all values and ranges therebetween, 550-700 C.) over a period of 0.5-10 hours (and all values and ranges therebetween, 1-3 hours), and thereafter the heat in the heating oven was maintained at the maximum temperature for 1-15 hours (and all values and ranges therebetween, 2-10 hours).

[0171] Once the final heating of the rod or post is completed, the rod or post can be removed from the heating oven and allowed to slowly cool. Generally, the rate of cooling after the final heat treatment step is less than 100 C./s (e.g., less than 1-100 C./s and all values and ranges therebetween), and typically less than 50 C./s, and more typically less than 25 C./s.

[0172] Once the rod or post has been cooled, the rod or post can then be cut to desired lengths (e.g., 20-500 mm [and all values and ranges therebetween] with a diameter of 3-8 mm [and all values and ranges therebetween]). As can be appreciated, the cut portions of the rod or post can be a) rod or post portions that were subjected to the final heating process, b) rod or post portions that were not subject to the final heating process, or c) rod or post portions where a portion was subjected to the final heating process and a portion that was not subjected to the final heating process. The physical properties of the rod or post portions can a) be uniform or substantially uniform along the longitudinal length of the rod or post portions, or b) vary along the longitudinal length of the rod or post portions.

[0173] As illustrated in FIG. 13, a refractory metal alloy or the metal alloy that includes at least 15 awt. % rhenium such as a MoRe alloy (e.g., 40-60 wt. % Re & 40-60 wt. % Mo) is subjected to different final heating processes wherein Test Rod 1 was not subjected to a final heating process and Test Rod 14 was subjected to the final heating process for the longest time period. Test Rods 2-13 were incrementally subjected to the final heating process for a longer period of time. As illustrated in Table 1, the longer the rod or post was subjected to the final heating process (which maximum temperature for each of the final heating processes was the same [e.g., 550-650 C., 600 C., etc.], the less force that was required to obtain a bending displacement of about 21.5%. As such, Table 1 illustrates rods or posts having the same cross-sectional shape and same cross-sectional area and formed of the same refractory metal alloy or the metal alloy that includes at least 15 awt. % rhenium can have different yield strength and ultimate tensile strengths after subjecting the rods or posts to different final heating processes. None of the rods or posts represented in FIG. 13 were quenched after the final heating processes. The rods or posts were allowed to cool by exposure of the rods or posts to the ambient temperature (e.g., 65 F.-85 F.) while placed in a non-oxidizing environment.

[0174] A non-limiting method for using a plurality of rods or posts having the same or similar size, shape and configuration and that are formed of the same refractory metal alloy or the metal alloy that includes at least 15 awt. % rhenium in a medical procedure, but the rods or posts have different physical properties with regard to at least the flexibility or bendability, yield strength and/or ultimate tensile strength includes: a) provided a plurality of spinal rods or spinal posts that i) are formed of the same metal alloy (e.g., refractory metal alloy [e.g., MoRe alloy, Re alloy, Mo alloy, Ta alloy, W alloy, etc.], metal alloy that includes at least 15 awt. % rhenium, etc.), ii) have a body member that is generally cylindrical in shape and has a constant cross-sectional shape and cross-sectional size or diameter along 60-100% (and all values and ranges therebetween) of the longitudinal length of the body member, iii) the body member of a plurality of the spinal rods or spinal posts has different physical properties with regard to at least the flexibility or bendability, yield strength and/or ultimate tensile strength due at least in part to the subjecting of the metal alloy on the body member of the plurality of the spinal rods or spinal posts to different final heating processes, and iv) the spinal rod or spinal posts optionally have one or more markings (e.g., color coatings, etchings on outer surface, symbols on outer surface, etc.) that are used to visually indicate the properties or relative properties of one or more or all of the spinal rods or spinal posts; b) identifying the location that a plurality of spinal rods or spinal posts are to be used in the spinal surgical procedure; c) determining the desired flexibility or bendability of each spinal rod or post that is be used in a certain location of the spinal during the spinal surgical procedure; d) selecting a spinal rod or post that has the desired flexibility or bendability (and wherein such selection is optionally based on a marking on the spinal rod or spinal post; e) selecting the spinal bone screws (e.g., pedicle screws) for use in the spinal procedure, and wherein each of the spinal bone screws include a top portion that includes a post opening that is configured to receive a portions of the spinal rod or spinal post so that the spinal rod or spinal post can be secured in the post opening to thereby secure the spinal rod or spinal post to the top portion of the spinal bone screw, and wherein the shape, size and configuration of the posting poring for a plurality of all of the spinal bone screws is the same; f) inserting two or more spinal bone screws into the bone (e.g., spine, etc.) of a patient; and g) securing the selected spinal rod or spinal post that have the desired flexibility or bendability to the spinal bone screws during the spinal surgical procedure.

[0175] Referring now to FIG. 2, when the medical device includes a frame that can be expanded or crimped (e.g., stent, frame of a heart valve, etc.), and the frame is partially or fully formed of a refractory metal alloy or a metal alloy that includes at least 15 awt. % rhenium, the amount of recoil of the frame after the crimping or expansion of the frame can be less than the amount of recoil of the same sized, shaped and configured frame that is formed of a different metal such as a CoCr alloy or a Ti alloy. As illustrated in FIG. 2, the crimping or expanding of a frame that is formed of CoCr alloy (e.g., 35Co-35Ni-20Cr-10Mo) will recoil by 9% or more (e.g., 9-15% and all values and ranges therebetween) after the radial crimping forces are removed from the frame. Frames formed of Ti alloy (e.g., e.g., Ti-6Al-4V) will recoil by 6% or more (e.g., 6-10% and all values and ranges therebetween) after the radial crimping or expanding forces are removed from the frame. Frames formed of a refractory metal alloy or the metal alloy that includes at least 15 awt. % rhenium (e.g., MoRe alloy, etc.) have a recoil of less than 2% when crimped or expanded as compared to similar shaped, size and configured frames formed of CoCr alloy or Ti alloy. Although not illustrated in FIG. 2, frame that are formed of stainless steel (e.g., 316, 316L) will also recoil by 7% or more (e.g., 6-15% and all values and ranges therebetween) after the radial crimping forces or expansion forces are removed from the frame.

[0176] Due to the recoil of frames formed of CoCr alloy, stainless steel or TiAlV alloy, the number of crimping cycles required to crimp a frame formed of refractory metal alloy or the metal alloy that includes at least 15 awt. % rhenium is significantly less than the number of crimping cycles needed to crimp a frame formed of stainless steel, CoCr or TiAlV. Typically, a frame formed of refractory metal alloy or the metal alloy that includes at least 15 awt. % rhenium requires only one crimping cycle to obtain the desired crimped profile of the frame. Typically, a frame formed of stainless steel, CoCr or Ti alloy requires at least two and generally three of more crimping cycles to obtain the desired crimped profile of the frame. Due to such recoil of frames formed of stainless steel, CoCr alloy or Ti alloy, the frame must be repeatedly subjected to a crimping force to attempt to obtain the smallest crimping outer diameter of the crimped frame. The need to subject the frame to multiple crimping cycles or procedures can potentially result in damage to the frame, and/or damage to other components of the medical device (e.g., leaflets, skirts, damage to balloon on the catheter, damage to one or more components on the catheter, etc.). Likewise, a frame formed of a refractory metal alloy or the metal alloy that includes at least 15 awt. % rhenium such as MoRe alloy also has less recoil after being expanded than a frame formed of stainless steel, CoCr or Ti alloy. As such, a frame formed of a refractory metal alloy or the metal alloy that includes at least 15 awt. % rhenium will better conform to the shape of the passageway wherein the frame is expanded. Furthermore, a frame formed of a refractory metal alloy or the metal alloy that includes at least 15 awt. % rhenium will expand to its desired expanded state from a single inflation of the balloon of the balloon delivery catheter. Due to the significant recoil of a frame formed of CoCr alloy, stainless steel (e.g., 316, 316L), and Ti alloy after expansion, the balloon of the balloon delivery catheter typically needs to be inflated multiple times to cause the frame to conform to the shape of the heart passageway wherein the frame is expanded. Such multiple inflations of the balloon can result in increased incidence of damage to a body passageway or the component of the medical device (e.g., leaflets, skirt, etc.).

[0177] FIG. 3 illustrates increased conformability to bending of a wire, rod or post formed of a refractory metal alloy or a metal alloy that includes at least 15 awt. % rhenium such as MoRe as compared to the same shaped, sized and configured wire, rod or post formed of CoCr alloy. When the frame of a medical device is expanded, the struts and posts of the frame plastically deform (e.g., generally deform outwardly) due to the expansion of the inflatable balloon or from some other expansion device. Generally, the treatment location where the medical device is expanded is not perfectly cylindrical nor has a perfectly shaped circular cross-sectional shape. Generally, the treatment area is damaged and/or includes plaque, calcium deposits and/or other materials (e.g., prior implanted medical devices, etc.) that cause the shape of the treatment area to be non-cylindrical-shaped or have a non-circular cross-sectional shape. As such, frames that can better conform to the irregular shapes in a treatment location result in a medical device that better fits the treatment area. It has been found that frames, wires, rods, struts, posts, etc. that are partially or fully formed of a refractory metal alloy or a metal alloy that includes at least 15 awt. % rhenium (e.g., MoRe alloys, etc.) better conforms to bending and/or shape of the passageway that the medical device is expanded into as compared to the same shaped, sized and configured frames, wires, rods, struts, posts, etc. that are partially or fully formed of metal alloys such as stainless steel, CoCr, Nitinol, and TiAlV alloys and stainless steel (e.g., 316, 316L). FIG. 3 illustrates that when the same sized, shaped and configured MoRe alloy wire and CoCr alloy wire are subjected to the same bending force, the MoRe alloy wire better conforms to the ideal bending shape IBS than the CoCr alloy wire, namely the MoRe alloy wire had 23% to 31% better conformity to the ideal bending shape than the wire formed of CoCr alloy. Tt has been found that wires formed of a refractory metal alloy or a metal alloy that includes at least 15 awt. % rhenium (e.g., MoRe alloy, ReW alloy, MoReCr alloy, MoReTa alloy, MoReTi alloy, WCu alloy, ReCr alloy, Mo alloy, Re alloy, W alloy, Ta alloy, Nb alloy) have about 15-45% (and all values and ranges therebetween) better conformity to bending to an idea bending shape than the same sized, shaped and configured wire formed of stainless steel, CoCr alloy, and TiAlV alloy.

[0178] Referring now to FIGS. 4A-4C, there are three graphs that illustrate stress vs. reduction in percent area a wire formed of TiAlV alloy, a CoCr alloy, and a MoRe alloy, and wherein each of the wires has the same size, shape and configuration. These three graphs illustrate that a medical device that is partially or fully formed of a frame, rod, post, strut, etc. made of a refractory metal alloy or a metal alloy that includes at least 15 awt. % rhenium such as MoRe will have has improved properties such as strength, yield strength, ultimate tensile strength, fatigue ductility, greater deformation latitude, material integrity between plastic deformation and failure, and durability as compared to the same shaped, sized and configured medical device that is partially or fully formed of a frame, rod, post, strut, etc. made of materials such CoCr alloys and TiAlV alloys. A medical device that is partially or fully formed of a frame, rod, post, strut, etc. made of refractory metal alloy or the metal alloy that includes at least 15 awt. % rhenium such as MoRe can have a strength of 1.5-5 times or more (and all values and ranges therebetween) greater than medical device that is partially or fully formed of a frame, rod, post, strut, etc. made of CoCr alloys and TiAlV alloys and stainless steel (e.g., 316, 316L).

[0179] Referring now to FIG. 5, a medical device that is partially or fully formed of a frame, rod, post, strut, etc. made of a refractory metal alloy or a metal alloy that includes at least 15 awt. % rhenium such as MoRe alloy generally has a greater stiffness and yield strength as compared to a medical device that is partially or fully formed of a frame, rod, post, strut, etc. made of CoCr alloys and TiAlV alloys or stainless steel (e.g., 316, 316L). The top curve of FIG. 5 is a MoRe alloy that includes 47.5 wt. % Re and the balance Mo. The middle curve of FIG. 5 is a CoCr alloy that includes 28 wt. % Cr, 6 wt. % Mo and the balance Co. The bottom curve of FIG. 5 is a TiAlV alloy that includes 6 wt. % Al, 4 wt. % V and the balance Ti. Although not illustrated, a refractory metal alloy or a metal alloy that includes at least 15 awt. % rhenium such as MoRe alloy will also have a greater stiffness and yield strength as compared to a medical device that is partially or fully formed of a frame, rod, post, strut, etc. made of stainless steel (e.g., 316, 316L, etc.).

[0180] Referring now FIGS. 6-8, there are three graphs that illustrate the yield strength, ultimate strength, and fatigue ductility of a wire formed of TiAlV alloy, CoCr alloy, and MoRe alloy after such alloys are cold worked to reduce the cross-sectional area of the alloy, and wherein the wires have the same size, shape and configuration. After being cold worked, wire that is formed a refractory metal alloy or a metal alloy that includes at least 15 awt. % rhenium such as MoRe alloy generally has greater fatigue ductility, yield strength, and ultimate strength than the shape shaped, sized and configured wire formed of CoCr alloy and TiAlV alloy and stainless steel (e.g., 316, 316L, etc.). Also, the cold working of a wire formed of a refractory metal alloy or a metal alloy that includes at least 15 awt. % rhenium such as MoRe alloy results in increased ductility of the wire. The graphs illustrate the opposite effect on ductility for a wire formed of CoCr alloy and TiAlV alloy and stainless steel (not shown) after the wire is subjected to additional cold working.

[0181] Referring now to FIG. 9, the hydrophilicity of wire formed of a refractory metal alloy or a metal alloy that includes at least 15 awt. % rhenium such as a MoRe alloy is compared to the same shaped, sized and configured wire formed of a CoCr alloy or TiAlV alloy. As illustrated in FIG. 9, CoCr alloys are hydrophobic materials resulting in a large contact angle (931) of a water droplet (e.g., distilled water) positioned on the surface of the wire formed of CoCr alloy. TiAlV alloys are a little more hydrophilic than CoCr alloys and exhibit a contact angle of 588 when a water droplet is positioned on the surface of the wire formed of Ti alloy. Refractory metal alloy or a metal alloy that includes at least 15 awt. % rhenium such as a MoRe alloy has a much greater hydrophilicity than CoCr alloys or TiAlV alloys. The wire formed of MoRe alloy has a contact angle of 373 when a water droplet is positioned on the surface of the wire formed of MoRe alloy. The surface of a frame, wire, strut, post, etc. that is formed of a refractory metal alloy or a metal alloy that includes at least 15 awt. % rhenium generally has a hydrophilicity wherein the contact angle of a water droplet on the surface of such frame, wire, strut, post, etc. is 25-45 (and all values and ranges therebetween), and typically 30-42.

[0182] Referring now to FIGS. 10-12, there are illustrated graphs and a table showing the ion release of a refractory metal alloy or a metal alloy that includes at least 15 awt. % rhenium such as MoRe alloy. As illustrated in FIG. 10, during the first day of implanting the medical device that includes a frame, strut, post, wire, etc. form of a refractory metal alloy or a metal alloy that includes at least 15 awt. % rhenium such as a MoRe alloy (e.g., 40-60 wt. % Re and 40-60 wt. % Mo) in a patient, the ion release of molybdenum was about 0.244 g/cm.sup.2 per day and the ion release of rhenium was about 0.115 g/cm.sup.2 per day. From days 1-3, the ion release of molybdenum was about 0.019 g/cm.sup.2 per day and the ion release of rhenium was about 0.013 g/cm.sup.2 per day. From days 3-7, the ion release of molybdenum was less than 0.001 g/cm.sup.2 per day and the ion release of rhenium was about 0.002 g/cm.sup.2 per day. From days 7-15, the ion release of molybdenum was about 0.002 g/cm.sup.2 per day and the ion release of rhenium was less than 0.001 g/cm.sup.2 per day. From days 15-30, the ion release of Mo was about 0.003 g/cm.sup.2 per day and the ion release of rhenium was less than 0.001 g/cm.sup.2 per day. The graph illustrates that after the seventh day of implantation in tissue, the ion release of molybdenum and rhenium from the MoRe alloy was effectively nonexistent.

[0183] Referring now to FIG. 11, the graph illustrates that the ion release of molybdenum from the MoRe alloy (e.g., 40-60 wt. % Re and 40-60 wt. % Mo) in a frame, strut, post, wire, etc. that was implanted or otherwise inserted in a patient was less than 1.5% of the allowed daily exposure to molybdenum during the first day of insertion of the MoRe alloy in a patient, and such daily ion exposure of molybdenum drops to 0.04% of the allowed daily exposure after 15 days. FIG. 11 also illustrates that the ion release of rhenium from the MoRe alloy in a frame, strut, post, wire, etc. that was implanted or otherwise inserted in a patient was less than 0.31% of the allowed daily exposure to rhenium during the first day of insertion of the MoRe alloy in a patient, and such daily ion exposure of rhenium drops to less than 0.01% of the allowed daily exposure after 15 days.

[0184] Referring now to FIG. 12, there is illustrated a table showing the amount of primary metals in the alloys of TiAlV, CoCr, stainless steel, and MoRe released into a patient after the medical device including such alloys is inserted into a patient for 90 days. The medical device that includes these allow is the same size, shape and configuration. As illustrated in the table of FIG. 12, the amount of molybdenum and rhenium contained in the tissue surrounding the MoRe alloy (e.g., 40-60 wt. % Re and 40-60 wt. % Mo) after 90 days is significantly lower than any of the primary metals of the other alloys. The amount of molybdenum metal ion in a gram of tissue from a 0.028 cm.sup.2/g dose of MoRe (e.g., 40-60 wt. % Re and 40-60 wt. % Mo) in the tissue after 90 days is 0.023 g/g. As such, the absolute increase in molybdenum metal ion relative to the dose size of the MoRe alloy in the tissue was 0.82. The amount of rhenium metal ion in a gram of tissue from a 0.028 cm.sup.2/g dose of MoRe in the tissue after 90 days is 0.014 g/g. As such, the absolute increase in Re metal ion relative to the dose size of the MoRe alloy in the tissue was 0.5. Based on absolute increase in metal ions in the tissue relative to the dose of the metal alloy in the tissue, both the molybdenum and rhenium content in the tissue from the MoRe alloy after the MoRe alloy was implanted in the tissue for 90 days was over 120 times less than the cobalt or chromium from the CoCr alloy, and many more times less than the other primary metals of the other tested alloys. Generally, the absolute ion release of the primary elements of the refractory metal alloy or the metal alloy that includes at least 15 awt. % rhenium (e.g., primary is an element in an alloy that is at least 2 wt. % of the alloy) relative to the dose of the refractory metal alloy or the metal alloy that includes at least 15 awt. % rhenium in the tissue after 90 days is at least 120 times less than any of the primary components of the alloys of TiAlV, CoCr, stainless steel when a similar does of these other alloys are imp[lated or otherwise inserted in a patient.

[0185] 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 disclosure, 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 disclosure 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 disclosure provided herein. This disclosure is intended to include all such modifications and alterations insofar as they come within the scope of the present disclosure. It is also to be understood that the following claims are intended to cover all of the generic and specific features of the disclosure herein described and all statements of the scope of the disclosure, which, as a matter of language, might be said to fall therebetween.