CUSTOM IMPLANTS Research, Regenerative Medicine and Personalized Surgery at Rizzoli Orthopedic Institute The Rizzoli RIT - Research, Innovation & Technology Department is the organizational branch managing the participation of the Rizzoli Orthopedic Institute to the Regional High Technology Network. “CUSTOM IMPLANTS” POR-FESR project addresses different aspects and technologies within the customized precision surgery. Its main objective is to make custom implantable products accessible to patients. PRECISION GRAFTING: Production of human precision tissues by robotized substractive manufacturing An innovative aseptic bone tissue processing platform has been developed and validated. It comprises a robotic arm and a 3D vision system based on laser scanner.

1. Emilia-Romagna Region, POR-FESR 2014-2020
ASSE 1 Research and Innovation
Call Regional Network of High Technology of Emilia-Romagna
PI: Prof.ssa Maria Paola Landini
Speaker: Ing. Leonardo Vivarelli

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3. CUSTOM IMPLANTS 3
CUSTOM IMPLANTS:
Design and manufacture of customized
tissues and endoprosthesis through
subtractive and additive technologies
 1. Precision-Grafting (PreGra):
Human precision tissues, by robotized
subtractive manufacturing
(RIT-PROMETEO e CIRI-ICT)
 2. Personalized-Scaffolds (PerSca):
Biomaterial and/or human cells devices, obtained by 3D printing and
in vitro cellularisation
2a. «mixed» structures, biomaterials and cells (RAMSES)
2b. magnetic cellularisation of microstructured scaffolds (NABI via MISTER)
 3. Custom-Endoprosthesis (CusEnd):
Prosthesis for replacement surgery, obtained
through metal alloys 3D printing and
polyethylene.
(MOVEMENT ANALISYS AND II CLINIC)
Confindustria Emilia Romagna Ricerca (CERR)
 C.A.T. Progetti Srl
 I+ Srl
 Samo Spa
 EnergyGroup Srl

4. CUSTOM IMPLANTS 4
Aprile‘16
Aprile‘17

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Precision Grafting
Human precision tissues, by robotized subtractive
manufacturing

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Precision Grafting
CNC Machining
Lab. PROMETEO
Since 2010, the PROMETEO Lab, in
collaboration with Musculoskeletal Tissue
Bank, has specialized in customizing grafts
thanks to a numerical control mill suitable for
clean rooms (Delta Macchine - Rieti), capable
to reproduce CAD-CAM models from
corticospongious bones.

7. CUSTOM IMPLANTS 7
Precision Grafting
Lab. PROMETEO
Project Activities
Design and
development of an
innovative tissue
processing platform
for clean rooms.
Choice of GMP-compatible
components and materials, compliant
with tissue processing guidelines.

8. CUSTOM IMPLANTS 8
Precision Grafting
Lab. PROMETEO
Choice of components
• Robot
Suitable for CR cleaning
products
Accuracy ±0,02 mm
• Spindle
Tool change
Lightweight structure
Internal overpressure to
prevent material
infiltration

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Precision Grafting
• Spindle machining tests
• Material tests
Lab. PROMETEO

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Precision Grafting
Lab. PROMETEO
• Assembling (frame, robot,
electronic, spindle,…)
• Programming robot
software (simulation,
communication, …)
Next step:
• CAD/CAM programming of
trajectories with proper
collision avoidance
• Use of 3D scanning of raw
materials to perform
complex machining
operations

11. CUSTOM IMPLANTS 111
1
• Study and development of a custom 3D laser scan
system based on eye-safe laser triangulation
techniques
• Geometric setup
Precision Grafting
CIRI-ICT

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2
• Scan system constraints:
Scan resolution
X (image plane) ~ 20-50 µm/pix
Y (scan axis) ~ 10-50 µm/pix
Z (subpixel) ~ 10-50 µm/pix
Baseline
Z
Y
X
image resolution: 1536x512 pixel
Geometric setup
Baseline 260 mm
angle 54 deg
Focal (+dist) 25 mm
FOV Width (up) 53,84 mm
FOV Width (down) 62,77 mm
Precision Grafting
CIRI-ICT

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Precision Grafting
Study and development of laser
scanning algorithms for highly
diffusive materials
CIRI-ICT
Preliminary scan prototype

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4
• 3D Reconstruction of lyophilized bone tissue
Actual prototype system
Iliac crest bone tissue
Top face of bone tissue
Precision Grafting
CIRI-ICT

15. CUSTOM IMPLANTS 15
• Frozen Bone Model acquisition
3D “raw” Point Cloud 3D bone CAD model
~1M 3D points
40 µm resolution
~900K faces
40 µm resolution
Bone tissue
Precision Grafting
CIRI-ICT