Medical applications of Additive Manufacturing Technologies in general

le centre collectif de l’industrie technologique belge

The collective centre of the Belgian technology industry

Agenda

• Sirris – an overview• Manufacturing of implants (past & current)• Patient – custom manufacturing of implants (current & future)• « Rapid Prototyping » & « Additive Manufacturing » technologies• Future of bio-manufacturing

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25/11/2011© sirris 2011 Charleroi | www.sirris.be | [email protected] |

Our centre

Federation for the technology industry

Collective centreof the technology industry

• Nonprofit organisation

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• Nonprofit organisation• Industry owned

“Increase the competitiveness of

companies of the Agoria sectors through

technological innovations”

Mission

© sirris 2011 Charleroi | www.sirris.be | [email protected] |

Our technological sectors

Aerospace Automotive Construction products

25/11/2011 4© sirris 2011 Charleroi | www.sirris.be | [email protected] |

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Contracting & Maintenance Electrical engineering

Industrial automation Mechatronical engineering

Information and communication technologies (ICT)

Metals & materials Metal processing Mounting & cranes

Plastics & composites Security & defence

Local presence, near the companies

LeuvenMechatronics

Technology Coaching

HasseltBrussels

GhentMaterials Engineering

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HasseltMaterials Engineering

Production Technology

CharleroiAdditive ManufacturingBio-Manufacturing Platform

BrusselsSoftware Engineering & ICTTechnology Coaching

LiègeAdditive ManufacturingMaterials Engineering

Nanomaterials


Additive Manufacturing Department (ADD)

le centre collectif de l’industrie technologique belgeThe Collective Centre of the Belgian Technology Industry

Medical Applications

Charleroi

Agenda


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Implant manufacturing (current & past)

Case study: Femoral & Total hip implants

• Today : Mass fabrication of standard femoral implants (& others)

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• Today : Mass fabrication of standard femoral implants (& others)

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[Société Royale Belge de Chirurgie Ortho et Traumato] [Critt MDTS 2008]


Current advanced pre-operative manufactured implants:


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[Hôpital St-Margueritte – Marseille, France, Départementd’Orthopédie]


Current advanced pre-operative manufactured implants:

CT scan Rapid Prototyping model


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Manual manufactured wax model Implant PMMA injection moulded

[Dr J. Poukens - UHasselt]


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• Evolution of medical imagery technology

=> Easy access to 3D world !

Need for custom implants !

Benefits of Additive Manufacturing @ Medical field

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Need of flexibility, complex structures and fast

response for surgery! Very small or even

standard (large) manufacturing series possible

Every human is different (anatomy)

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Next generation pre-operative manufactured implants:

• Custom implant manufacture :

• CT-Scan• CAD File of the patient is produced• Engineer + Surgeon 3D implant approved• FEM analysis (when needed)• Custom manufacturing (low cost)• Surgery

The utility of Additive Manufacturing technologies

in the medical field

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• Surgery• Follow up


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[Sirris ADD]

[Sirris ADD][Sirris ADD]

Medical Additive Manufacturing Software:

ADD capacities & competencies

• Materialise: Mimics• Materialise: 3-matic• Marcam: Autofab• Able Software Corp: 3D Doctor• Medicim: Maxilim

ProEngineer

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• ProEngineer• New: Lenexa: Analyze• New: Brisbane: Anatomics• (…)

[Mimics & 3-matic - Materialise]

Subtractive technologies...

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Rapid Prototyping / Tooling / Manufacturing

Process…

(…)


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Process…

• Basic data :

Scan / 3D CAD files – STL

• Pre-treatment :

STL corrections, orientation, supports, 2D slicing

3D CAD File

3D STL File


STL corrections, orientation, supports, 2D slicing

• Manufacturing :

Full automatic

• Post-treatment :

Cleaning, sand blasting, coating, finishing

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Σ 2D layers

Sliced File

Rapid Prototyping

• Stereolithography

• Bi-material 3D Printing

• 3D Printing of wax

• Selective Laser Sintering

• 3D Printing of polymers / plaster

Rapid Prototyping vs Additive Manufacturing

Additive Manufacturing

• Electron Beam Melting

• Selective Laser Melting

• Laser Cladding

• Hybrids of Stereolithography

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• 3D Printing of polymers / plaster

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Functionalparts

Final parts

Visual parts

SIRRIS – World leader: Most complete machine park

• 15 engineers and technicians • Two locations: Liège (10 p.) and Charleroi (5 p.)


• Stereolithography (normal & hi-res)• Paste polymerisation for ceramics and metals (Optoform)

Sirris ADD capacities & competencies

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• Paste polymerisation for ceramics and metals (Optoform)• 3D Printing of plaster and metal powder• Laser sintering of polymeric powder (PA,…): P360 – P390• Objet Connex 500: bi-material• Laser sintering of metal powder (parts and mould inserts)• Electron Beam Melting (Arcam A2)• 3D Printing of wax (Thermojet)• Vacuum Casting of Alu, Bronze, Zamak• Laser Cladding (EasyClad) • Selective Laser melting (MTT)

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The utility of Rapid Prototyping / Manufacturing in

the medical field

Trends in biocompatible materials used in Rapid Prototyping / Manufacturing:

Metals:

• Titanium (Ti6Al4V)• Stainless steel• Shape memory alloys (Ni-Ti) – in research• Noble materials (Gold)

Polymers:

• PTFE (Polytetrafluoroethylene)• PMMA (Polymethyl methaacrylate)• PE (Polyethylene)• … others, too but not implantable

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• Noble materials (Gold)• …

Ceramics:

• Hydroxyapatite (HAP)• Zirconia• Tricalcium phosphate (TCP)• Alumine• …


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• … others, too but not implantable

Others:

• Hydrogels• Human cells


the medical field

Leading applications:

• Pre-surgical planning:

• Custom implant manufacture[Arcam & Objet technology]

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• Physician to physician communication

• Powerful patient presentation tool

• Medical student/resident education

• 3D Surface Scanning/Custom Prosthesis Design


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[Z. Corp Medical Modeling Solutions]


[Objet Connex Eden 500]


• Pre-surgical planning:

• Implant pre-contouring• Screw trajectory• Screw selection/location• Instrument selection• Technique rehearsal

“No matter how good our 3-D graphics are, there isnothing like a model in your hands . . .”


the medical field


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[Objet]

[Objet]

[Objet Connex Eden 500]

[Objet]


• Pre-surgical planning advantages:

• Significantly reduces O.R. time• Lowers cost• Reduces O.R. team fatigue

• Enhances patient outcomes• Reduces “re-do” procedures


the medical field

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• Reduces “re-do” procedures• Minimizes size of incisions• Speeds recovery time• Improves anatomical alignment• Enables multiple procedure rehearsals


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[Case study: The Alfred Hospital, Melbourne, Australia]

Towards newly designed implants


• Today: Custom-fit femoral implants

25© sirris 2011 Charleroi | www.sirris.be | [email protected] |

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Medical Field: CASE STUDIES @ SIRRIS


• Physician to physician communication

• Powerful patient presentation tool

• Medical student/resident education


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[Sirris ADD] [Sirris ADD]

[Sirris ADD] [Sirris ADD] [Sirris ADD] [Sirris ADD]



• Custom Prosthesis Design

• Complex parts manufacturing


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[Sirris ADD]

[Sirris ADD]


Spinal & CMF case studies in HAP/TCP:

• Porous scaffolds in Hydroxyapatite Ca5(PO4)3(OH)• Diameter ~= 10mm• Macro-porosity ~= 0,5mm• Tests various scaffold structures for bone integration• In vivo testing (rabbits)• Machine: Optoform• Field: Maxillofacial Surgery in France (Client is confidential)


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• Field: Maxillofacial Surgery in France (Client is confidential)• Production of 1000 parts / month (total of 10.000 in 2011)

[Sirris ADD]



Project: “Optobio”

Client: Osseomatrix (Dr Nimal)

• Porous & dense orbital implant in Hydroxyapatite Ca5(PO4)3(OH)

1,4mm


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0,5mm

1,4mm


Project: “Optobio”

Client: Osseomatrix (Dr Nimal)


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Project: Surgical Cutting Template

• CHU Reims (France) • 100% dense Ti6Al4V Titanium• Build time: 6 hours• Weight: 75g• Machine: Arcam A2 (Electron Beam Melting)• Field: Oral and Maxillofacial Plastic Surgery

[Sirris ADD]


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Project : Surgical Cutting Template

• UCL-St Luc (Belgium) • 100% dense Ti6Al4V Titanium• Build time: 4 hours• Weight: 25g• Machine: Arcam A2 (Electron Beam Melting)• Field: Oral and Maxillofacial Plastic Surgery

[Sirris ADD]

[Sirris ADD]


Demonstration part: Knee implant

• 100% dense Ti6Al4V Titanium with porous Ti6Al4V scaffolds• Build time: 8 hours• Weight: 170g• Machine: Arcam A2 (Electron Beam Melting)• Field: Knee implant orthopaedics

[Sirris ADD]


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Demonstration part: Craniofacial implant

• Sirris (Belgium) • Porous Ti6Al4V Titanium scaffold implant• Polyamide skull on Z-Corp machine • Machine: Arcam A2 (Electron Beam Melting)• Field: Cranio-plastic surgery

[Sirris ADD]

[Sirris ADD]


Project: “ HEROL” (2002: 4 years)

• Goals: • Enhance the performances of CMF surgery, implant placement accuracy• Enlarge the fields of applications through AM technologies• Processing & editing of 2D CT-Scans• Decrease operating time• Simplify complex operations


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• Simplify complex operations

Example of end-user: A.C.M. Implants (Belgium)• 3D reconstruction of the hip

• Decision & pre-operation planning for surgeons

• Plaster cast on Z-Corp machine with post finishing

• Collaboration: Sirris; UCL; CERISIC

• Results: creation of spin-off: « CenTIS » (www.centis.be)

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Project: “ Nanoker” (2005: 4 years) large scaled European project

• Goals:• Development of nanomaterials for improved tribologicalapplications• Fabrication on the Optoform machine• Fields of applications : Knee and hip implants, dental applications


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• Results:• Development of a very reactive Alumina paste containing 8% of Zirconia nano powders

• Partners (25): www.nanoker-society.org

[Sirris ADD]

[Sirris ADD]

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Project: “ BIOFACT” (2007 - 2013)

• Goals: • Design, fabrication and establishment of an external feed prosthesis controlled by neuronal signals (EEG instead of EMG)• Creation of the “Biomanufacturing platform” in Charleroi• Thermodynamic control, calculation and validation of the EBM process


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• Technologies involved: Connex Eden 500, Arcam A2

• Partners: Sirris; CENAERO; UMONS, CETTIC, ULB

• Results: creation of spin-off: « Human Waves » (soon)

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Medical Field: CASE STUDIES in the world

Replacement of Temporomandibular joints

• Reference: Dr. Jules Poukens, Cranio-maxillofacial Surgeon and Lecturer University Hasselt• Custom fit Titanium implant with surface porosity: allowing tissue ingrowth & stability• Polyethylene part fixed to the Titanium implant: flat functional surface & providing a centric relation posititon for the condyle• Stereolithographic model for validation


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Replacement of Temporomandibular joints


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Agenda


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[Butscher A., et al., Structural and material approaches to bone tissue engineering in powder-based three-dimensional printing. Acta Biomater (2010)]

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Ceramics



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Elasticity (Young's Modulus)

Yield strength Resilience Hardness In vivo resistance

(phys.-chem.)

Bone response to implant material

Metals

Polymers

[Black J., et al., Orthopaedic biomaterials in research and practice. Churchill Livingstone. New York: P.394, 1988]



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Ti6Al4V: E(GPa) = 110 !



• Tomorrow: Custom-fit femoral implants & adapted Young’s modulus

• Patient custom-fit implants• Better distribution of the stresses• Reducing stress-shielding• Reducing micro-motion between bone & sinkage• Surface roughness for strong fixation• Hydroxyapatite coating eased up• Complex biodegradable scaffolds combining HAP & βTCP


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• Complex biodegradable scaffolds combining HAP & βTCP

+ +

[Sirris - ADD]

[Sirris - ADD]

CT-scan data

Data processing & exporting

3D modeling – CAD & FEA

Custom fit & dense implant 3D microstructure

3D cellular microstructure Lattice structures

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STL file

Implant manufacturing

Post processingMilling HAP/TCP coating

Sterelization

Surgery

Surgeon validation&

Control by experts

[Butscher A et al.]

Finger implant (Dr. P. Ledoux, Prof. G. Guerlement UMONS)



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Proximalpart

Distalpart

Metacarpal bone

Trapezium(Wirst)

Finger implant (Dr. P. Ledoux, Prof. G. Guerlement UMONS)



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The future of bio-manufacturing…not so far away!


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Sirris Additive Manufacturing: Contact

Carsten ENGEL

R&D Biomedical Engineer

Mail: [email protected]: +32 498 91 94 50


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Mobile: +32 498 91 94 50Skype: Carsten-Engel

SIRRISRue Auguste Piccard, 20B-6041 GOSSELIES BELGIUMhttp://www.sirris.be

Medical applications of Additive Manufacturing Technologies in general

Documents

electron beam

operative

rapid prototyping

patient custom

maxillofacial

current advanced

standard femoral

implant manufacturing