3D et applications chirurgicales pour une médecine innovante et personnalisée

Khanh TRAN DUY, Co-CEO, 3D Side

Jeudi 10 décembre

3D et applications chirurgicales pour une médecine innovante et personnalisée.

Liege Creative, en partenariat avec :

BONE TUMOR SURGERY

Advanced planning &

Patient Specific Instruments

3D et applications chirurgicales pour une médecine innovante et personnalisée

•  Introduction

•  Technical workflow at 3D-Side

•  General workflow for a surgery

•  Cases examples

•  Feasability of 3D technology in the biomedical field

•  Conclusion !!

3D-SIDE SA is a spin off (Université catholique de Louvain – Belgium)

! 3 Years of activity in Belgium, France and Spain

! Focused on 3D technologies utilization for

complex surgery

!  Dedicated software infrastructures

!  Dedicated manufacturing capabilities

!  ISO 13485 in preparation (in 2015)

!!!

Simula(on!

3D!Models!

Surgical!guides!

Dedicated!implants!

Implant(design((Per0opera2ve(mold(for(PMMA(bone(cement((

3D(Planning(Mul2modal(Registra2on(

((((

(

Skull(Curvature(Mold(crea2on(in(3D((

Pa2ent(bone((Allogra@((Resec2on(

(Pa2ent(Skull(

Resec2on((guide(

Allogra@(guide(implant(guide(

The way it works

Pre-operative assistance Intra-operative assistance

Tumor Location

Resection Planning

Patient Specific Instruments MRI / CTscan

Segmentation Registration

Volume creation Simulation 3D Printing

Techniques : Imaging !

Segmentation Overlap Volume creation

Techniques : Imaging !

CTScan CT Scan + MRI Registration

The way it works


Tumor Location

Resection Planning




Techniques : Simulation !

3D-Manipulation/ Planning

The way it works


Tumor Location

Resection Planning




Techniques : 3D-Printing !

3D Object Slicer Layered object

+! =!1!

Laser draws a 2D layer

New layer of powder is sprayed

2!

Cleanning and sandblasting

3!

Powder cake including objects

Biomedical 3D Technologies Key points

"  Multi techniques

Basic example !

Volume Creation Simulation 3D-Printing


"  Multi techniques "  Flexibility

!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!Clinical!complica(ons!!!&!!!Func(onal!issues!!!!!!!!!!!!!!!!!!!!!!!!28%!to!35%!of!local!recurrence#!!!!!!!!!$Inaccurate!reconstruc(on!!

!!!

Tumor Location !!!

Resection Path !!!

Transfer on Patient

!!!

Cuttings

Pre-operative errors Intra-operative errors

GLOBAL!RESECTION!INACCURACY!

Bone Tumor Surgery: Issues & Challenges

Tumor Application !

Workflow

!!

Visit our secured website www.3Dside.eu/demand

!!

Upload CT scans & MRI

Step 1 Images Transfer

✓ 3

Planning Tumor Instruments

2 1

Workflow !

2

Delineate the tumor

Step 2 Pre-operative planning Supervision/validation

SURGEONS

✓ 3 2


Workflow !

2

Define all your needs through the application or website


SURGEONS

✓ 3

Planning Tumor Instruments !!✓✓

Workflow !

2


SURGEONS

Worflow !

Step 3 Surgery


"  Multi techniques "  Flexibility "  Custom made communication "  Learning curve from surgeons

Performances

Manual Instruments Times!(min.) 52 8*

Intralesional!resec(on 4 (17%)

0* (0%)

Loca(on!(mm)!(CI!95%)

11.2 (9.8 ; 12.6)

1.7* (1.5 ; 2.1)

*significantly different at p<0.05

Gouin!F!et!al.!ComputerQAssisted!Planning!and!Pa(entQSpecific!Instruments!for!Bone!Tumor!Resec(on!within!the!Pelvis:!A!Series!of!11!Pa(ents.!Sarcoma.!014;2014:842709!


"  Multi techniques "  Flexibility "  Custom made communication "  Learning curve from surgeons "  Precision

Case examples : Pelvis with implant

✓ 3


2 1


✓ 3 2



✓ 3 2



"  Multi techniques "  Flexibility "  Custom made communication "  Learning curve from surgeons "  Precision "  Standard collaboration


✓ 3


Case examples : Pelvis with allograft

✓ 3


2 1


✓ 3 2


✓ 3 2



✓ 3



Step 3 Surgery


Step 3 Surgery


Case examples : Femur 1

Case examples : Femur 2


"  Multi techniques "  Flexibility "  Custom made communication "  Learning curve from surgeons "  Precision "  Standard collaboration "  Trans-disciplinary "  Long process during design vs use in the or "  Short delay if good communication "  Insertion in surgeon workflow "  Complex cases

Cranioplasty : Problems

!Gold standard :

cranioplasty with PMMA (hand made)

!!

!-  Aesthetics

-  Exothermicity of PMMA

-  Time consuming

-  Tricky in OR

-  …

!!

Cranioplasty : Solutions

Company! Country! Website! Material!

Xilloc

The

Netherlands

www.xilloc.com

PEEK

De Puy-Synthes

USA

www.depuysynthes.com

PEEK

Codman

Custombone

Italy USA

https://www.depuysynthes.com/about/codman-neuro

HA

Cranioplasty : Problems

Problems

-  Thickness (Codman)

-  No opportunities for adjusting (milling,..)

-  Cost (8keuro or more)

-  Lead Time (few weeks – 6 for Codman)

-  Strong interaction with the surgeon required :

osteosynthesis positions & number, central suspension, …

-  …

!!!

Cranioplasty : Our Solution


Peroperative Injection of PMMA in a patient Specific Mold


•  Fast in OR, no skills required, “funny” to perform

•  Short Lead time (10 days or faster)

•  Complex shape possible

•  Full thickness implant

•  Flexible in OR (osteosynthesis selection, milling, suspension,…)

•  Cost reduction

•  Less constraints on CT dose (due to adaptability in OR)

•  Exothermicity in the mold permit a better polymerization of the PMMA

•  The surgeon can freely select the osteosynthesis mean, as well as their number and location, as usual with the standard method

•  A second implant can be manufactured if required (competitors send two implants).

•  Less/no hands contact during shaping – better sterility

•  The implant can adapt (size augmentation or reduction) in case of larger preoperative resection.


!!!

Standard manual method

CustomBone

J&J

Our PSI² - Mold PMMA

Complex shapes possible - + ++

Adaptability in OR – reduction + -- ++

A d a p t a b i l i t y i n O R – augmentation

+ - +

Central suspension + - +

Freedom for osteosynthesis material

++ - ++

Exothermicity on patient tissues -- ++ ++

Time in OR -- ++ +

Mechanical strength - -- +

Sterility - ++ +

Costs ++ - +

Thin structures possible + - ++

Radio opacity + + +

Osteo-integration possible - + -

Results - aesthetics -- ++ ++

Lead time +++ -- +

Case examples

Segmenta2on((

Op2misa2on(géométrique(

Reconstruc2on(3D(

Détermina2on(de(la(résec2on(&(Design(de(l’implant(

Valida2on((de(l’implant(maître(sur(modèles(3D(

Step 1 Design /simulation

Case examples

Step 2

Modèle(3D(en(salle(Stériles(et(biocompa2bles(

Visualisa2on(de(la(résec2on(à(effectuer(et((pose(des(guides(de(résec2on(

Modèle(de(résec2on(Guides(de(résec2on(

Per-op visualization

Case examples

Step 3 Pose(des(guides(et(marquage((monopolaire)(

Résec2on(obtenue(

Résec2on(

Guidage et résection

Case examples

Step 4

Prépara2on(et(fixa2on(

Implant(PMMA(fabriqué(en(salle(validé(sur(le(modèle(3D( Pose(finale(avec(adapta2on(de(la(

suspension(centrale(

Pose de l’implant

Case examples

Step 1 Design /simulation

Segmenta2on((Reconstruc2on(3D(

Détermina2on(de(la(résec2on(

Pre0design(de(l’implant(

Case examples

Step 2 Per-op visualization

Modèle(et(résec2on( Valida2on((de(l’implant(maître(sur(modèles(3D(

Modèle(réséqué(

Sinus(&(plafond(Vérifica2on(des(fixa2ons((

Case examples

Step 3 Implant fabrication

Valida2on((de(l’implant(maître(sur(modèles(3D(

Injec2on(en(salle(Durant(l’anesthésie(

Case examples

Step 4 Per-OP Resection and visualization

Modèle(3D(en(salle(Stériles(et(biocompa2bles(

Visualisa2on(de(la(résec2on(à(effectuer(et((pose(des(guides(de(résec2on(

Guides(de(résec2on( Modèle(de(résec2on(

Case examples

Step 5 PER-OP RESECTION

Adaptabilité( Prépara2on((

Case examples

Step 5 Pose de l’implant

Placement(0(copie( Suspension(et(fixa2on(

Tumor resection + cranioplasty

Implant(design(Segmenta2on( Resec2on((Superposi2on(((

Fabrica(on!selon!spécifica(ons!((tanium,!ceramic,!PMMA,…)!

Prototypage(

Guide(per0opératoire( Implant(en(place(

Other cases

Reconstruc2on((3D(

Transfert(–(fabrica2on(du(guide(de(forage((

Planning(0(choix(et(pliage(de(la(plaque((

Per0opératoire(((

Other cases

Planning!de!reconstruc(on! Planning!de!!mise!en!forme!

Planning!de!résec(on!

IRM CT

2D! 3D!


"  Multi techniques "  Flexibility "  Custom made communication "  Learning curve from surgeons "  Precision "  Standard collaboration "  Trans-disciplinary "  Long process during design vs use in the or "  Short delay if good communication "  Insertion in surgeon workflow "  Complex cases "  Costs "  Reimbursment "  Global gain "  Certfication /quality "  No CE labelling "  Risks managment in OR "  Do we need engineers?

Thank you for your attention

Health & Medicine

3D et applications chirurgicales pour une médecine innovante et personnalisée