Keith Jackson Technical Director ZUUDEE

Titanium in Biomedical Applications

Titanium in Biomedical Applications

Requirements for Medical Devices Reduce pain Increase mobility Correct abnormality or deformity No adverse biological response Reliable performance Strength Long service life Titanium Properties High strength Fracture toughness Low modulus Low weight Corrosion resistance Biocompatible Non magnetic

Julius Wolff German Anatomist 1836 - 1902

Julius Wolff German Anatomist 1836 - 1902

Wolffs Law

Bone is deposited and resorbed in accordance with the stresses placed upon it.

Wolffs Law

Friedrich Pauwels 1885 -1980

Pauwels Theory

Cells subjected to stress and strain differentiate into fibroblasts and chondroblasts

Bone Remodelling

Stress Shielding
Bones are constantly remodelled by osteoblasts and osteoclasts Implants much stiffer than bone will bear more of the load, reducing stress in the bone. The body will respond by increasing osteoclast activity, causing bone resorption. Cancellous bone is more biologically active and resorbs much more quickly than cortical bone.

Mechanical Properties
The lower modulus of titanium alloys compared to other implant metals is a positive factor in reducing bone resorbtion.

www.doitpoms.ac.uk

Titanium alloys suitable for medical applications

ASTM F67 F136 F1472 F1295 F1580 F1713 F1813 BS 7252 / ISO 5832 Part 2 Part 3 Part 3 Part 11 Part 10 Alloy(s) Designation(s) Unalloyed titanium CP grades 1-4 (ASTM F1341 specifies wire) Ti6Al4V ELI wrought (ASTM F620 specifies ELI forgings) Ti6Al4V standard grade (SG) wrought (F1108 specifies SG castings) Ti6Al7Nb wrought Ti5Al2.5Fe wrought CP and Ti6Al4V SG powders for coating implants Ti13Nb13Zr wrought Ti12Mo6Zr2Fe wrought More than 1,000 tonnes of titanium devices are implanted in patients worldwide every year.

Dental Applications

Titanium is corrosion resistant

Dental Applications

Pioneered in the early 1950s by Swedish scientist Per-Ingvar Branemark

Dental Applications

Maxillofacial and Craniofacial Applications

Cardiovascular Applications

Cardiovascular Applications

Titanium is non magnetic

Cardiovascular Applications

Trauma

Trauma

Trauma

Trauma

Spinal Implants

Spinal Implants

Joint Replacement Implants

More than 1 million hip and knee replacements performed world-wide each year

Market drivers for improved implant performance

1. INCREASED LIFE EXPECTANCY By 2050, 25% of the UK population will be over 65

http://www.statistics.gov.uk

Market drivers for improved implant performance

2. HEAVIER PATIENTS

Market drivers for improved implant performance

3. EARLIER SURGICAL INTERVENTION typical historic patient > 65 years (1 million steps/year) younger patients demand: increased survivorship 20 40 years and optimised function Traditional patients = 20 million steps / lifetime Young active patients = 200 million steps / lifetime 10 x increase in demand on joint replacement implant compared with older patients

Market drivers for improved implant performance

4. IMPROVED FUNCTION Increased range of movement Increased stability Reduced risk of dislocation

Titanium Joint Replacements

Concerns and Challenges Some cases of fatigue failure due to high loads and millions of loading cycles Other implant materials provide better bearing surfaces Titanium is the material of choice for cementless implant fixation, however it is no longer used with bone cement due to the potential for crevice corrosion Titanium is bioinert so no adverse biological reaction, however fibrous tissue encapsulation can lead to micro-motion, pain and loosening Surface modification is required to deliver reliable implant fixation in the long-term Improved implant performance at an acceptable cost

Fatigue Failure

64 year-old man weighing 70 kg performed strenuous manual labour forged Ti 6Al V4 alloy femoral stem size 12mm Four years after original operation the patient experienced severe pain in the left hip while walking The implant was well fixed

UHMWPE wear problem

Metal on Polyethylene Bearing Couple Particulate UHMWPE wear debris Activation of macrophages in periprosthetic tissue Release of cytokine TNF alpha Osteoclasts Osteolysis Aseptic Loosening

Titanium not suitable as an implant bearing

Titanium not suitable as an implant bearing

Classification of Biomaterials (Osborn 1979)

TISSUE REACTION

MATERIAL

CLASSIFICATION

SYMBOL

Bone Cement Metal Alloys Titanium Alumina Carbon Fibre Hydroxy-apatite

Distance Osteogenesis

Biotolerated

Contact Osteogenesis

Bioinert

Bonding Osteogenesis

Bioactive

Classification of Biomaterials (Osborn 1979)

Stainless Steel implant Biotolerated (distance)

Carbon implant Bioinert (contact)

New bone

HAC

H-A.C. Coated implant Bioactive (bonding)

Surface morphology of Titanium

Tecotex Computer-generated, photo-etched, 3D surface textures

Porous titanium surfaces

CSTi (Cancellous-Structured Titanium) Porous Coating

Porous titanium surfaces

Furlong H-A.C. Total Hip Replacement

The First in the World implanted by Ronald Furlong FRCS 1985

Titanium alloy components (Ti6Al4V)

Coated Implant Fixation

Titanium Alloy Ti-6Al-4V Hydroxyapatite Ceramic Bilateral osteogenesis Chemical bond with bone Physiological Fixation

H-A.C. Coated Titanium

Furlong & Osborn JBJS 73(B)741-5 1991

Norwegian Arthroplasty Register Acta Orthopaedica Scandinavica

Supravit HAC VPS Coating

HAC Coating Cross-section SEM

HAC

Ti

Ti-6Al-4V

ESEM image of bone formation on Supravit

Supravit HAC - Bone Interface

Field width 0.07mm

Furlong H.A.C Femoral Stem Histology - Supravit

Furlong H.A.C Femoral Stem Histology - Supravit

Manufacturing Process

Machining

Glazing & Polishing

Ceramic Coating

Metrology

Clean, Pack & Sterilise

Regulatory Affairs
Medical Devices Directive 93/42/EEC for CE Marking. ISO 9001:2008 Quality Management System (QMS). ISO 13485:2003 QMS for Medical Devices. USA Food & Drug Administration (FDA) 21 CFR Part 820. ISO 14001:2005 Environmental Management BS OHSAS 18001:2007 : Health & Safety Management

Thank you for your attention

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