A
Beta Titanium Alloy for Medical Device Applications
Flexium™
is a superelastic ß titanium alloy ideally suited for
orthodontic, orthopedic and other medical applications. Devices
and appliances made of Flexium™ offers the following advantages:
-
Low modulus compatible with bone elasticity
-
Good strain recovery
-
Excellent biocompatibility
The alloy has excellent flexibility and low modulus and can
be used in either cast or wrought condition. The devices made
of Flexium™ can be fabricated by casting, cold working
and/or machining, and can be readily joined to other Ti components
and coated to finish.
Metallurgical Properties
Flexium™ is a single-phase titanium alloy of body-center-cubic
(bcc) ß structure after ß solution treatment and
subsequent rapid cooling. The alloy possesses a critical ß
stability such that when deformed crystalline phase change
(martensitic transformation) or twining occurs giving rise
to unique superelatic properties. The key properties of the
alloy are listed in Table 1 in comparison to those of Ti-64
alloy.
Table
1. Comparison of properties between betatized Flexium™
and Ti-64 alloy
| Property |
Flexium™ |
Ti-64 |
| Nominal
Composition |
Ti-9.8Mo-4Nb-2V-3Al |
Ti-6Al-4V |
| Metallurgical
Microstructure |
ß |
+ß |
| Density |
0.173
lb/in3 (4.8 g/cm3) |
0.160
lb/in3 (4.4 g/cm3) |
| Melting
Point |
1,700°C |
1,650°C |
| Transus |
850°C |
980°C |
| Annealing
Temperature |
870°C-900°C |
700°C
-785°C |
| Young’s
Modulus |
7-10
x 106 psi (50-70 GPa) |
16.5
x 106 psi (113.8 GPa) |
| Plateau
Stresses |
60-80
Ksi (450 - 600 Mpa) |
N/A |
| Yield
strength |
60-80
Ksi (450 – 600 Mpa) |
128
Ksi (880 Mpa) |
| Ultimate
Tensile Strength |
110
– 130 Ksi (750 - 900 Mpa) |
138
Ksi (950 Mpa) |
| Recoverable
Strain |
3
– 3.5% |
0.5% |
| Tensile
Elongation |
15-20% |
14% |
| Reduction
of Area |
40-45% |
36% |
| Hardness
(Vickers Scale) |
300Hv |
350Hv |
Effects
of Cold Work
Young’s Modulus
Young’s modulus of the alloy decreases with increasing
amount of cold work. It drops from ~10 Msi for the betatized
material to ~7 Msi after cold-working with reductions greater
than 30% (Figure 1).
Tensile Strength (UTS)
The UTS is around 120 Ksi for materials in the fully
betatized condition. With a small amount of
precipitate, the UTS can be elevated to higher than 150 Ksi.
Cold working further increases the tensile strength as shown
in Figure 2 to ~170 Ksi after a 50% reduction. The data suggests
a weak work hardening effect.
Figure 1.
Effect of cold work on Young’s modulus.
Figure 2.
Effect of cold work on tensile strength (UTS).
Superelasticity
Betatized materials exhibit pseudoelasticity (Figure 3). In
contrast, the alloy after cold working exhibits linear superelasticity.
A strain as high as 3% maybe recoverable in cold-worked materials.
Examples of tensile stress-strain curves tested to 2% and
4% elongations of wires with a 19.4% cold-work reduction are
shown in Figure 4. Ductility however decreases significantly
when the cold work exceeds 25% reduction.
Figure 3.
Stress-strain curve of ß-tizedFlexium™
(a)
(b)
Figure
4. Stress-strain curves of a 19.4% cold-worked Flexium™
wire tested to (a) 2% and (b) 4% tensile elongation
Effects of Heat Treatments
Brief aging of betatized materials for less than 30 minutes
at 350 – 500°C generally improves pseudoelastic
strain recovery. Avoid prolong aging at these temperatures
as it leads to
precipitation and embrittles the alloy.
precipitation at 500-800°C also degrades elasticity. High
temperature heat treatments and brazing must be carried out
in either vacuum or inert gas atmosphere to avoid oxygen contamination
and the formation of
case. Significant
case may degrade the flexibility and eventually embrittles
the material.
Machining Characteristics
The machining characteristics for Flexium™
are generally similar to those for Ti-64. The alloy can be
milled or turned using similar feed rates and cutting fluids
for Ti-64 alloys with high speed steel tools. Longer tool
life and better surface finish can be achieved with carbide
tools. Milling and turning chips are typically stringy. Flexium?
is slightly easier to drill or to grind when compared to Ti-64
alloys which tend to create bright sparks and wear out the
wheel quickly. Flexium™ galls less, creates less heat
and wears out the tools much less than does Ti-64 during these
operations.
Corrosion Properties:
The corrosion resistance of Flexium™ is excellent. The
key parameters are listed in Table 2 in comparison with those
of Ti-64. A typical potentiodynamic polarization curve of
annealed Flexium™ is shown in Figure 5. Cold-worked
alloys exhibit similar corrosion characteristics.
Table 2. Comparison of corrosion properties between Flexium™
and Ti-64 alloy
| Parameter |
Flexium |
Ti-64 |
| Corrosion
Potential |
-0.26
(V, SCE) |
-0.35
(V, SCE) |
| Breakdown
Potential |
>
1.2 (V, SCE) |
>1.0
(V, SCE) |
| Current
density in passive region |
5.6E-6
(A/cm2) |
1.5E-6
(A/cm2) |

Figure
5. Cyclic polarization curves for mechanically polished Flexium™.
Biocompatibility:
The alloy is biocompatibile and exhibits no toxicity as demonstrated
by the test results in Table 3.
Table 3. Biocompatibility test results of Flexium™.
| Test |
Method |
Criteria |
Results |
| Cytotoxicity |
MEM
Elution per ISO 10993-5 (L929 mouse fibroblast cell culture) |
(no
reactivity) to grade 4 (severe reactivity) |
Grade
0 |
| Irritation |
Intracutaneous
Injection/4 extracts-ISO 10993-10 |
Overt
signs of toxicity at injection sites up to 72 hrs |
None |
| Hemolysis |
Extract/Human
Blood per ISO 10993-4 |
5%
or less hemolysis (90 minute incubation) |
0.0% |
| Hemolysis |
Direct
Contact/Human Blood per ISO 10993-4 |
5%
or less hemolysis (90 minute incubation) |
0.3% |
| Systemic
Toxicity |
Systemic
Injection/4 Extracts per ISO 10933-11 |
Biological
reactions of mice – 72 hrs post inoculation |
None |
| Systemic
Toxicity |
Rabbit
Pyrogen/Material Mediated per ISO 10993-11 |
Less
than 0.5°C rise in body temperature (up to 3 hrs subsequent
to injection) |
0.0,
0.0 and 0.1°C |
| Implantation |
Implant/Muscle/2
Weeks per ISO 10993-7 |
Signs
of inflammation, encapsulation, hemorrhage, necrosis,
discoloration or other microscopic biological reactions. |
None |
|