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Bio Material

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gmssr76
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© © All Rights Reserved
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1. Chromium (Passivity):

Chromium provides corrosion resistance to stainless steel by forming a stable chromium oxide
(Cr₂O₃) layer on its surface.
This oxide layer (~2 nm thick) adheres well to the surface and promotes self-healing in the
presence of oxygen, enhancing corrosion resistance.
2.Nickel (pssivity)

Nickel improves both corrosion resistance and mechanical properties of stainless steel.
It stabilizes the face-centered cubic (FCC) structure (austenite) in iron, enhancing corrosion
resistance.
Alloys with closely packed structures (FCC) are more resistant to corrosion than loosely packed
structures due to stronger chemical bonds between atoms.
Nickel also increases corrosion resistance by forming a protective nickel oxide (NiO) layer on the
surface of the alloy.
4. Molybdenum (Carbide Formation and Minimization of Pitting Corrosion):

- The addition of other alloying elements can enhance corrosion resistance or develop desired
mechanical/physical properties.
- The use of molybdenum further increases resistance to pitting corrosion caused by chromium
carbide formation.
- Pitting corrosion leads to the formation of small holes in metals due to depassivation of small
areas.
- In chromium steels, chromium forms carbides at carbon-rich grain boundaries, depleting
chromium and causing localized corrosion.
- Adding molybdenum can trap carbon by forming molybdenum carbides, reducing chromium
carbide formation and improving corrosion resistance.
- The chemistry of 316L stainless steel is designed to maximize resistance to pitting corrosion.
5.Nitrogen (Enhance Resistance to Pitting and Crevice Corrosion):
- Crevice corrosion refers to corrosion occurring in a confined space with limited access of the
surrounding fluid.
- In passivatable alloys like stainless steels, crevice corrosion is caused by gradual acidification
inside the crevice, leading to aggressive local conditions that destroy passivity.
- Nitrogen is soluble in high levels in austenitic stainless steels and stabilizes the austenitic
structure, increasing mechanical strength and enhancing resistance to pitting and crevice
corrosion.
- Nitrogen-containing alloys like ASTM F1586 (Orthinox) and ASTM F2229 have been developed
for medical use to take advantage of this increased corrosion resistance.
6.Stress Corrosion Cracking:
- Stress corrosion cracking (SCC) is an unexpected sudden brittle failure of normally ductile
metals under tensile stress in a mildly corrosive environment.
- SCC frequently occurs in stainless steels that work in a chloride-rich medium, where Cl- or OH-
ions are believed to play a critical role in SCC failure.
- Caution must be taken in applications of stainless steel implants, as body fluid is both aqueous
and chloride-rich.
- Ferritic (BCC structured) stainless steels have limited applications in medical devices, while
duplex (FCC matrix with BCC structured phase) steels have yet to make an impact in the
biomedical field.
- Only austenitic (FCC) stainless steels are used for orthopedic implants.

7.Biocompatibility of Stainless Steels:


- Stainless steel has reasonably good biocompatibility, recognized by the success of total hip
replacements in the 1960s and 1970s.
- However, the biocompatibility is less satisfactory than CoCrMo alloys or Ti alloys due to higher
corrosion rates.
- The systemic toxicity and carcinogenicity of released nickel and chromium are major concerns.
8.Mechanical Properties of Implant-Grade Stainless Steels:
- Mechanical properties like yield strength, fatigue strength, and elongation vary not only with
alloy type but also with processing conditions.
- The high-nitrogen variants (F1314, F1586, F2229) are stronger than the original 316
composition (F138).
- The fatigue strength of F138 stainless steel is typically 300-400 MPa in air or 200-300 MPa in a
biological aqueous solution, which may not be sufficient for total hip replacement loading.

Fatigue Properties and Application Limitations:


- The wear resistance of 316L stainless steel is relatively poor, and wear debris can lead to
allergic reactions in surrounding tissue.
- Fatigue crack initiation is frequently correlated to the presence of surface imperfections on
metals.
- Corrosion pits in stainless steels in saline solutions act as stress raisers and preferential sites
for fatigue crack initiation.
- Adding elements like molybdenum and nitrogen, which improve pitting corrosion resistance, is
an effective way to improve the corrosion fatigue resistance of stainless-steel implants.
- The fatigue strength of the high-nitrogen alloys F1586 (Orthinox) and F2229 is typically around
500 MPa, well above the maximum loading stress of hip stems.
9.Application Principles of Stainless Steels in Orthopedics:
- Failures due to corrosion, fatigue, and SCC in stainless steels happen after a long service
period, not in a short time.
- 316L stainless steels can be used in temporary devices like nails, screws, and bone plates, as
they are removed after healing.
- The low cost of 316L steels has maintained their use in a large number of short-term
temporary devices.

Permanent Implant Applications:


- If the loading stress is lower than the fatigue and SCC strength of the alloy, fatigue and SCC
will virtually never happen.
- Stainless steels have been used in permanent implants for shoulders, where loading stresses
are generally lower than the fatigue and SCC strength of 316L stainless steels.
- However, the fatigue strength of 316L stainless steel (~300 MPa) is not recommended for
permanent implants at high-stress regions like hips, knees, and ankles.
- Orthinox is less susceptible to fatigue or SCC at these highly stressed regions due to its
improved resistance to pitting, crevice corrosion, and higher mechanical strength.

10.Critical-Sized Defects:
- The healing ability of defects left behind after temporary device removal is size-dependent.
- A critical-sized defect (CSD) is the minimal defect that cannot heal without medical
manipulation, regardless of healing time.
- Smaller defects like screw holes can heal spontaneously after the temporary device is
removed.
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1.Cobalt-Based Alloys:
- The cobalt-based superalloy (high performance alloy) called stellite was originally developed
by Haynes for aircraft engines.
- Cobalt-based alloys were first used in medical implants in the 1930s. The CoCrMo alloy
vitallium was used as a cast dental alloy and then adapted for orthopedic applications in the
1940s.
- By modifying vitallium, a range of cobalt-based alloys have been developed with compositions
listed in the table.

2.Corrosion Resistance of Cobalt-Chromium Alloys:


- Cobalt-chromium-based alloys are superior to stainless steels in corrosion resistance,
demonstrating excellent performance in a chloride-rich environment.
- The high chromium content leads to the formation of a passive oxide (Cr2O3) layer within the
human body fluid environment.
- Cr, Mo, and Ni are responsible for the corrosion resistance, similar to their roles in stainless
steels.
- However, the casting and forging conditions of these alloys can significantly influence their
corrosion resistance and mechanical properties. Casting gives rise to coarse grains and defects,
while wrought alloys have better fatigue strength and fracture toughness.
3.Biocompatibility of Cobalt Alloys:
- The first application of cobalt alloy in hip implants was in 1939, slightly later than stainless
steels.
- In vitro evaluation showed the CoCrMo alloy is much less toxic than pure cobalt or nickel due
to its excellent corrosion resistance.
- However, patients with CoCrMo metal-on-metal bearing systems are still exposed to wearing
debris over a long period, which liberates cobalt and chromium into the blood via the synovial
fluid.
- There have been increasing concerns over elevated serum metal ion levels, potential
teratogenic effects, and adverse local tissue reactions from these incidents.
4.Mechanical Properties of Medical-Grade Cobalt Alloys:
- The excellent corrosion resistance of CoCr-based alloys is primarily imparted by alloying
chromium.
- The superior mechanical properties over stainless steels are due to the crystallographic nature
of the base element cobalt.
- The superior wear and fatigue resistances of cobalt alloys arise from their two closely packed
structures: HCP and FCC.
- The solid-state phase transformation, chromium-tungsten-molybdenum additions, and metal
carbides all contribute to the superb fatigue resistance of this alloy system.
- CoCr alloys can be used in either cast or wrought forms.
Comparison with Stainless Steels:
- The presence of the second BCC-structured phase strengthens and hardens the FCC-
structured austenitic steels.
- However, the BCC structure is relatively loosely packed, making the alloy susceptible to SCC
and fatigue. For this reason, duplex stainless steels are not used in the biomedical field.
- ASTM F75 is a cast Co-Cr-Mo alloy with excellent corrosion and wear resistance, used in
aerospace and biomedical industries.
5.Medical Applications of Cobalt Alloys
Cobalt-chromium (CoCrMo) alloys are widely used in medical implants, particularly for total
joint replacements like hips, knees, and ankles. Their superior fatigue resistance makes them a
preferred choice. However, they have some drawbacks such as high cost, stress-shielding
effects, and potential metal toxicity.
Key points about CoCrMo alloys:
* Advantages: High fatigue resistance, suitable for high-stress areas.
* Disadvantages: High cost, stress-shielding (can weaken bone), potential metal toxicity.
* Applications: Total hip, knee, and ankle replacements.
Titanium Alloys in Medical Implants
Titanium alloys are another popular choice for medical implants due to their low density,
biocompatibility, and corrosion resistance.
Key points about titanium alloys:
* Advantages: Low density, biocompatible, corrosion resistant.
* Disadvantages: Can be more expensive than some other options.
* Applications: Wide range of medical implants, including those used in orthopedic surgery.
Comparison between CoCrMo and Titanium Alloys
* CoCrMo: High strength, but can cause stress-shielding and potential metal toxicity.
* Titanium: Lower density, biocompatible, but can be more expensive
6. Current Issues and Challenges with Wrought CoCrMo Alloys
Wrought cobalt-chromium-molybdenum (CoCrMo) alloys, while widely used in medical
implants, face several challenges that limit their widespread adoption.
Key issues include:
* High cost: CoCrMo alloys are more expensive compared to stainless steels, making them less
accessible for medical applications.
* Stress shielding: These alloys have a much higher stiffness (Young's modulus) than natural
bone. This can lead to a phenomenon called stress shielding, where the implant takes on most
of the load, causing the bone to weaken and potentially leading to bone loss and implant
failure.
* Metal toxicity: Some of the elements in CoCrMo alloys, such as nickel, chromium, and cobalt,
can be released into the body and cause systemic allergic reactions and inflammation.
* Wear and debris: Over time, the interface between the implant and bone can wear down,
creating wear debris that can contribute to inflammation and tissue damage.
.
7. Titanium Alloys
Titanium is a lightweight metal, significantly lighter than iron and cobalt. It undergoes a
structural change at high temperatures, altering its crystalline structure. Based on this
structural difference, titanium alloys are classified into four main categories: alpha, near-alpha,
alpha-beta, and beta alloys. The alpha-beta alloy, specifically Ti-6Al-4V, is the most commonly
used titanium alloy in various applications.
Titanium Alloys in Biomedical Applications
In the medical field, both commercially pure titanium and Ti-6Al-4V alloys are widely used for
implants. However, in recent years, there has been a growing trend towards using beta
titanium alloys for surgical implants. Various standards set by ASTM (American Society for
Testing and Materials) govern the use of titanium and its alloys in medical devices.
Key points:
* Titanium is a lightweight metal.
* Titanium alloys have different crystalline structures.
* Ti-6Al-4V is the most common titanium alloy.
* Titanium and its alloys are widely used in medical implants.
* ASTM standards regulate the use of titanium alloys in medical devices.
8.Corrosion Resistance of Titanium and Its Alloys
Titanium and its alloys exhibit exceptional corrosion resistance under a wide range of
conditions, including oxidizing, neutral, and mildly reducing environments. This remarkable
property is due to the formation of a stable, protective titanium oxide film. This oxide layer is
highly adherent and quickly repairs itself when damaged, ensuring long-lasting corrosion
protection.
Key points about titanium and its alloys:
* Excellent corrosion resistance: Due to a stable, protective oxide film.
* Biocompatibility: Titanium alloys are well-tolerated by the body and promote tissue
integration.
* Applications: Widely used in medical implants due to their corrosion resistance and
biocompatibility.
9.Biocompatibility of Titanium Alloys
The text discusses the exceptional biocompatibility of titanium alloys, making them highly
desirable for medical implants.
Key points about biocompatibility:
* Superior to other metals: Titanium alloys, particularly those containing elements like V, Al,
Nb, Zr, Mo, Fe, and Ta, exhibit superior biocompatibility compared to stainless steel and cobalt
alloys.
* Non-reactivity: Elemental titanium is non-reactive, meaning it doesn't cause adverse
reactions when implanted in the body.
* No rejection: Titanium implants are not rejected by the body and form strong bonds with
bone tissue.
* Safety: Titanium alloys have been shown to be safe for both animals and humans, with
minimal mutagenicity.
* First-generation alloys: While first-generation alloys like Ti-6Al-4V have been used, they
contain vanadium which can cause toxicity.
* Second-generation alloys: Newer alloys have been developed with improved biocompatibility
by replacing vanadium with elements like Nb, Zr, and Mo.
Key points about bone-bonding ability:
* Unique feature: Titanium alloys are the only metallic biomaterial that can form a direct bond
with bone tissue.
* Titanate formation: The formation of titanate on the surface of titanium implants promotes
bone growth and attachment.
* Enhanced bone-bonding: Coatings of TiO2 on titanium implants further enhance bone-
bonding.
* Permanent implants: Titanium alloys are primarily used in permanent implants due to their
strong bond with bone.
* Temporary implants: Titanium alloys can also be used for short-term temporary implants, but
long-term follow-up data is limited

10.Bone-Bonding Ability of Titanium Alloys


The text discusses the unique ability of titanium alloys to bond with bone tissue, making them
highly favored for medical implants.
Key points:
* Superior to other metals: Titanium alloys are the only metallic biomaterial that can form a
direct bond with bone tissue, unlike stainless steel and cobalt alloys which form a capsule
around the implant.
* Titanate formation: The formation of titanate on the surface of titanium implants promotes
bone growth and attachment.
* Enhanced bone-bonding: Coatings of TiO2 on titanium implants further enhance bone-
bonding.
* Permanent implants: Titanium alloys are primarily used in permanent implants due to their
strong bond with bone.
* Temporary implants: Titanium alloys can also be used for short-term temporary implants, but
long-term follow-up data is limited.

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