Medical applications of Additive Manufacturing Technologies in general

The collective centre of the Belgian technology industry

le centre collectif de l’industrie technologique belge

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

© sirris 2011 Charleroi | www.sirris.be | info@sirris.be | 25/11/2011 2
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Our centre

Federation Collective centre
for the technology industry of the technology industry
• Nonprofit organisation
• Industry owned

Mission
competitiveness of
“Increase the
companies of the Agoria sectors through
technological innovations”

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Our technological sectors

Aerospace Automotive Construction products
Contracting & Maintenance Electrical engineering
Industrial automation Mechatronical engineering

Information and communication technologies (ICT)
Metals & materials Metal processing Mounting & cranes
Plastics & composites Security & defence

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Local presence, near the companies

Ghent Leuven
Materials Engineering Mechatronics
Technology Coaching

Brussels Hasselt
Software Engineering & ICT Materials Engineering
Technology Coaching Production Technology

Liège
Charleroi Additive Manufacturing
Additive Manufacturing Materials Engineering
Bio-Manufacturing Platform Nanomaterials

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Additive Manufacturing Department (ADD)

Medical
Applications

Charleroi The Collective Centre of the Belgian Technology Industry
le centre collectif de l’industrie technologique belge

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)

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

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Current advanced pre-operative manufactured implants:

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

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Current advanced pre-operative manufactured implants:

CT scan Rapid Prototyping model

Manual manufactured wax model Implant PMMA injection moulded

[Dr J. Poukens - UHasselt]

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Agenda


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Benefits of Additive Manufacturing @ Medical field

• Evolution of medical imagery technology
=> Easy access to 3D world !

Need for custom implants !
Every human is different (anatomy)

Need of flexibility, complex structures and fast
response for surgery! Very small or even
standard (large) manufacturing series possible

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The utility of Additive Manufacturing technologies
in the medical field

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
• Follow up
[Sirris ADD]

[Sirris ADD]
[Sirris ADD]

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ADD capacities & competencies

Medical Additive Manufacturing Software:

• Materialise: Mimics
• Materialise: 3-matic
• Marcam: Autofab
• Able Software Corp: 3D Doctor
• Medicim: Maxilim
• ProEngineer
• New: Lenexa: Analyze
• New: Brisbane: Anatomics
• (…)

[Mimics & 3-matic - Materialise]

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Subtractive technologies...

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Rapid Prototyping / Tooling / Manufacturing
Process…

(…)

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Process…
3D CAD File

• Basic data :
Scan / 3D CAD files – STL

• Pre-treatment : 3D STL File
STL corrections, orientation, supports, 2D slicing

• Manufacturing :
Full automatic

Sliced File
• Post-treatment :
Cleaning, sand blasting, coating, finishing

Σ 2D layers

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Rapid Prototyping vs Additive Manufacturing

Rapid Prototyping Additive Manufacturing
• Stereolithography • Electron Beam Melting
• Bi-material 3D Printing • Selective Laser Melting
• 3D Printing of wax • Laser Cladding
• Selective Laser Sintering • Hybrids of Stereolithography
• 3D Printing of polymers / plaster

Functional
parts

Visual Final
parts parts

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Sirris ADD capacities & competencies

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)
• 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: Polymers:

• Titanium (Ti6Al4V) • PTFE (Polytetrafluoroethylene)
• Stainless steel • PMMA (Polymethyl methaacrylate)
• Shape memory alloys (Ni-Ti) – in research • PE (Polyethylene)
• Noble materials (Gold) • … others, too but not implantable
• …
Others:
Ceramics:
• Hydrogels
• Hydroxyapatite (HAP) • Human cells
• Zirconia
• Tricalcium phosphate (TCP)
• Alumine
• …

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the medical field

Leading applications:

• Pre-surgical planning:
[Arcam & Objet technology]
• Custom implant manufacture
• Physician to physician communication
• Powerful patient presentation tool [Z. Corp Medical Modeling Solutions]

• Medical student/resident education
• 3D Surface Scanning/Custom Prosthesis Design
[Objet Connex Eden 500]

[Z. Corp Medical Modeling Solutions]

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the medical field

Leading applications: “No matter how good our 3-D graphics are, there is
nothing like a model in your hands . . .”
• Pre-surgical planning:
• Implant pre-contouring
• Screw trajectory
• Screw selection/location
• Instrument selection
• Technique rehearsal

[Objet] [Objet]

[Objet Connex Eden 500]

[Objet]

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the medical field


• Pre-surgical planning advantages:
• Significantly reduces O.R. time
• Lowers cost
• Reduces O.R. team fatigue
• Enhances patient outcomes
• Reduces “re-do” procedures
• Minimizes size of incisions [Z. Corp Medical Modeling Solutions]
• Speeds recovery time
• Improves anatomical alignment
• Enables multiple procedure rehearsals

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

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Towards newly designed implants


• Today: Custom-fit femoral implants

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Medical Field: CASE STUDIES @ SIRRIS


• Physician to physician communication
• Powerful patient presentation tool
• Medical student/resident education

[Sirris ADD] [Sirris ADD]

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

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• Custom Prosthesis Design
• Complex parts manufacturing


[Sirris ADD]


[Sirris ADD]

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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)
• Production of 1000 parts / month (total of 10.000 in 2011)

[Sirris ADD]


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Project: “Optobio”
Client: Osseomatrix (Dr Nimal)

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

1,4mm

0,5mm


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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]

Project: Surgical Cutting Template

• UCL-St Luc (Belgium)
• 100% dense Ti6Al4V Titanium
• Weight: 25g
• Field: Oral and Maxillofacial Plastic Surgery
[Sirris ADD]

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Demonstration part: Knee implant

• 100% dense Ti6Al4V Titanium with porous Ti6Al4V scaffolds
• Weight: 170g
• Field: Knee implant orthopaedics

[Sirris ADD]

Demonstration part: Craniofacial implant
• Sirris (Belgium)
• Porous Ti6Al4V Titanium scaffold implant
• Polyamide skull on Z-Corp machine
• Field: Cranio-plastic surgery

[Sirris ADD]

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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

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 tribological
applications
• Fabrication on the Optoform machine
• Fields of applications : Knee and hip implants, dental
applications

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

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

[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

• 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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3,5

3

2,5

2
Ceramics
1,5 Metals
Polymers
1

0,5

0
Elasticity Yield strength Resilience Hardness In vivo Bone response
(Young's resistance to implant
Modulus) (phys.-chem.) material

[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 !

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• 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

+ +

[Sirris - ADD]

[Sirris - ADD]

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CT-scan data

Data processing & exporting
3D cellular microstructure Lattice structures
3D modeling – CAD & FEA

Custom fit & dense implant + 3D microstructure

STL file

Implant manufacturing

Milling Post processing HAP/TCP coating [Butscher A et al.]

Sterelization Surgeon validation
&
Surgery Control by experts

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

Distal Metacarpal bone
part

Trapezium
(Wirst)
Proximal
part

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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: carsten.engel@sirris.be
Mobile: +32 498 91 94 50
Skype: Carsten-Engel

SIRRIS
Rue Auguste Piccard, 20
B-6041 GOSSELIES BELGIUM
http://www.sirris.be

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Medical applications of Additive Manufacturing Technologies in general

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