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À PROPOS DES AUTEURS
<figure><img src="image_46.png" /></figure>
**Laurent Douesnel** est chirurgien maxillo-facial au sein de l'Assistance Publique-Hôpitaux de Paris. Il se spécialise dans les technologies de conception et d'impression 3D aux côtés du Professeur Khonsari à l'hôpital universitaire Necker - Enfants malades. Précédemment au cours de son internat, il a rejoint l'équipe du Professeur Corre, à Nantes, qui engageait un processus de certification de la plateforme 3D interne, et a collaboré au projet. Sa thèse d'exercice de médecine soutenue en 2023 a présenté la synthèse de ce travail, et est à l'origine de la réalisation du présent ouvrage. Pour en savoir plus sur ce projet : Douesnel L. Fabrication additive en chirurgie orthognathique : principes, réglementation et étude de cas [thèse d'exercice]. Université Paris Cité ; 2023. https://dumas.ccsd.cnrs.fr/dumas-04583387

https://orcid.org/0009-0003-1922-9286

**Roman Hossein Khonsari** est chirurgien craniofacial à l'Hôpital Necker - Enfants malades et professeur à l'université Paris Cité. Il dirige le laboratoire Forme et Croissance du Crâne à l'Institut Imagine. Il est également directeur médical du Health Data Hub. Durant la pandémie, il a créé une ferme géante d'imprimantes 3D pour répondre en urgence aux besoins sanitaires en matériel médical. Cette ferme est aujourd'hui devenue PRIM3D, un service pérenne de fabrication additive et de médecine quantitative pour l'ensemble des hôpitaux de l'Assistance Publique - Hôpitaux de Paris. Ce service d'un nouveau genre interagit avec tous les soignants et coordonne des projets transversaux, de la maintenance à la pédagogie en passant par l'innovation chirurgicale. PRIM3D fédère également un réseau de plateformes 3D de CHU à l'échelle nationale. Pour en savoir plus sur le projet d'impression 3D pendant le Covid-19 : Khonsari RH (2023). *Emergency medical 3D printing*. L'Harmattan.

https://orcid.org/0000-0002-0649-1432
**Déclaration de conflit d'intérêt.** Les auteurs déclarent qu'ils n'ont aucun lien d'intérêt financier, commercial ou personnel avec les fabricants d'imprimantes 3D ou les entreprises mentionnés dans cet ouvrage. Les informations présentées sont fondées sur une recherche indépendante et impartiale, avec un objectif de partage des connaissances. Aucune des sociétés citées n'a influencé ou soutenu financièrement la rédaction de ce livre.

**Note de l'éditeur.** Cet ouvrage comporte un ensemble d'hyperliens vers des pages de site Internet ou vers des fichiers téléchargeables. Sauf mention contraire, la validité de ces hyperliens ainsi que l'accès aux informations correspondantes ont été contrôlés en date du 1er septembre 2024.
# Table des matières

## Introduction 1

## L'impression 3D 5

1 Définition de l'impression tridimensionnelle 6

2 Histoire de l'impression 3D 8

3 L'impression 3D en pratique 11

3.1 Intérêts 11

3.2 Les matériaux 12

3.3 Différents types d'imprimantes 17

4 Applications de l'impression 3D 31

4.1 Applications générales 31

4.2 Applications médicales 32

4.3 Applications en chirurgie, chirurgie maxillo-faciale et stomatologie 33

5 Aspect règlementaire 39

5.1 Définitions 40

5.2 Mise sur le marché 44

6 Flux numérique 53

6.1 Planification chirurgicale 53

6.2 Impression du dispositif médical et post-traitement 54

6.3 Stérilisation 55

6.4 Stockage 55

6.5 Temps chirurgical 55

6.6 Suivi clinique 55

7 État des lieux de l'impression 3D en chirurgie 57

7.1 En France 57

7.2 En Europe 58

7.3 Cas particulier du Royaume-Uni 60

8 Sécurité et toxicité de l'impression 3D 63

8.1 Exemple de l'impression par dépôt de filament fondu 63

8.2 Exemple de l'impression métallique 64

8.3 Conséquences cardiovasculaires 65

8.4 Conséquences respiratoires 66

8.5 Mesures préventives 66

## Domaine d'intérêt : la chirurgie orthognathique 71

1 Généralités sur la chirurgie orthognathique 72

2 Dysmorphoses dento-squelettiques 74

2.1 Analyse clinique de la face 74

2.2 Analyse de la denture 78
<table><tbody><tr><td>2.3 Analyse fonctionnelle</td><td>81</td></tr><tr><td>2.4 Analyse radiologique</td><td>82</td></tr><tr><td>2.5 Analyse des modèles dentaires</td><td>83</td></tr><tr><td>3 Transfert de la planification vers le temps opératoire</td><td>84</td></tr><tr><td>3.1 Chirurgie à main levée</td><td>84</td></tr><tr><td>3.2 Gouttières d'occlusion</td><td>85</td></tr><tr><td>4 Place de l'impression 3D en chirurgie orthognathique</td><td>91</td></tr><tr><td>4.1 Planification virtuelle et gouttières imprimées</td><td>91</td></tr><tr><td>4.2 Guides de coupe et guides de positionnement</td><td>94</td></tr><tr><td>4.3 Guides chirurgicaux et plaques sur mesure</td><td>96</td></tr><tr><td>4.4 Autres applications des technologies 3D en chirurgie orthognathique</td><td>99</td></tr><tr><td><strong>Justification d'une chaîne de production intra-hospitalière</strong></td><td><strong>101</strong></td></tr><tr><td>1 Internaliser ou externaliser la production</td><td>102</td></tr><tr><td>2 Coût de production</td><td>104</td></tr><tr><td>2.1 Coût rapporté au temps opératoire</td><td>104</td></tr><tr><td>2.2 Estimation du coût de production in house</td><td>105</td></tr><tr><td>2.3 Coût d'une production in house versus coût d'une production externalisée</td><td>105</td></tr><tr><td>3 Temps de production et fenêtre thérapeutique</td><td>107</td></tr><tr><td>4 Modernisation du monde hospitalier</td><td>109</td></tr><tr><td>5 Centralisation du parcours de soins autour du chirurgien</td><td>110</td></tr><tr><td>6 Communication entre praticiens</td><td>111</td></tr><tr><td>7 Formation du personnel médical</td><td>111</td></tr><tr><td>8 Innovation et amélioration des DM</td><td>111</td></tr><tr><td>9 Responsabilité</td><td>112</td></tr><tr><td>10 Partage d'informations sensibles hors du milieu hospitalier et propriété intellectuelle</td><td>113</td></tr><tr><td><strong>Installation d'un flux numérique interne</strong></td><td><strong>115</strong></td></tr><tr><td>1 Exemple d'un flux numérique : conception de gouttières occlusales, de la consultation pré-chirurgicale au suivi post-opératoire</td><td>116</td></tr><tr><td>1.1 Consultations orthodontico-chirurgicales pré-chirurgicales</td><td>117</td></tr><tr><td>1.2 Planification virtuelle et conception de la gouttière</td><td>118</td></tr><tr><td>1.3 Impression et post-traitement de la gouttière</td><td>118</td></tr><tr><td>1.4 Stérilisation et stockage</td><td>118</td></tr><tr><td>1.5 Temps chirurgical</td><td>118</td></tr><tr><td>1.6 Suivi post-opératoire et reprise du traitement orthodontique</td><td>119</td></tr><tr><td>2 Dossier de certification</td><td>120</td></tr><tr><td>2.1 Définition et classe du dispositif médical</td><td>120</td></tr><tr><td>2.2 Cadre réglementaire</td><td>121</td></tr><tr><td>2.3 En pratique</td><td>122</td></tr><tr><td>3 Déclaration publique</td><td>123</td></tr><tr><td>4 Justification</td><td>124</td></tr><tr><td>4.1 Cadre règlementaire</td><td>124</td></tr></tbody></table>
<table><tr><td>4.2</td><td>En pratique</td><td>125</td></tr><tr><td>5</td><td>Choix du matériel</td><td>126</td></tr><tr><td>5.1</td><td>Technologie d'impression et choix de l'imprimante</td><td>126</td></tr><tr><td>5.2</td><td>Matériau d'impression</td><td>130</td></tr><tr><td>5.3</td><td>Prise d'empreinte optique et scanner intra-oral</td><td>132</td></tr><tr><td>5.4</td><td>Choix des logiciels</td><td>134</td></tr><tr><td>5.5</td><td>Choix de l'occlusion finale</td><td>141</td></tr><tr><td>6</td><td>Stérilisation et conditionnement</td><td>145</td></tr><tr><td>7</td><td>Organisation logistique</td><td>148</td></tr><tr><td>7.1</td><td>Imprimante et outils de post-traitement</td><td>148</td></tr><tr><td>7.2</td><td>Consommables d'impression et d'acquisition</td><td>148</td></tr><tr><td>7.3</td><td>Logiciels</td><td>148</td></tr><tr><td>7.4</td><td>Traçabilité</td><td>149</td></tr><tr><td>8</td><td>Organisation spatiale, local dédié</td><td>150</td></tr><tr><td>8.1</td><td>Sécurité</td><td>150</td></tr><tr><td>8.2</td><td>Organisation du local dédié</td><td>151</td></tr><tr><td>9</td><td>Documents associés au dispositif médical</td><td>155</td></tr><tr><td>9.1</td><td>Validation de conformité</td><td>155</td></tr><tr><td>9.2</td><td>Étiquettes</td><td>156</td></tr><tr><td>9.3</td><td>Notice d'utilisation</td><td>158</td></tr><tr><td>10</td><td>Système de gestion de la qualité</td><td>161</td></tr><tr><td>11</td><td>Plan de gestion de risque</td><td>164</td></tr><tr><td>11.1</td><td>Évaluation du risque</td><td>165</td></tr><tr><td>12</td><td>Évaluation clinique et suivi après commercialisation</td><td>179</td></tr><tr><td>12.1</td><td>Suivi clinique après commercialisation (SCAC)</td><td>179</td></tr><tr><td>12.2</td><td>Notification des incidents graves et mesures correctives de sécurité</td><td>180</td></tr><tr><td>13</td><td>Documentation diverse pouvant être requise par l'autorité compétente</td><td>182</td></tr><tr><td>14</td><td>Et maintenant ? Prochaines étapes nécessaires pour compléter le dossier de certification</td><td>183</td></tr><tr><td colspan="2">Conclusions</td><td>185</td></tr><tr><td colspan="2">LISTE DES ABBRÉVIATIONS</td><td>189</td></tr><tr><td colspan="2">BIBLIOGRAPHIE</td><td>195</td></tr><tr><td colspan="2">À PROPOS DES AUTEURS</td><td>223</td></tr></table>
Publié par l'université Paris Cité, 85 boulevard Saint-Germain 75006 Paris

Édition : Alice Trotignon, Vincent Colpin
(Direction Générale déléguée aux Bibliothèques et Musées, Université Paris Cité)

Impression : Ateliers de l'université Paris Cité

Dépôt légal : novembre 2024

Imprimé sur papier FSC
# L'impression 3D en chirurgie orthognathique : principes, réglementation et étude de cas

Par Laurent Douesnel et Roman Hossein Khonsari

En quelques années, l'impression 3D s'est imposée dans le quotidien des soignants. Elle contribue à offrir des soins sur mesure dans de nombreux secteurs en permettant la production de dispositifs médicaux spécifiques aux patients.

Ce livre présente, avec le point de vue des chirurgiens maxillo-faciaux, les apports de la fabrication additive dans le domaine de la chirurgie orthognathique – chirurgie qui consiste à repositionner les bases osseuses des tiers moyen et inférieur de la face. L'analyse qu'il propose intègre la dimension réglementaire de la fabrication additive appliquée aux dispositifs médicaux (règlement européen UE 2017/745), réglementation au regard de laquelle il existe, à ce jour, peu de projets de production intrahospitalière conformes.

L'ouvrage aborde un ensemble de notions générales sur l'impression 3D : les technologies employées dans le domaine chirurgical et les solutions présentes sur le marché. Sont développés les applications, le déploiement de cette technologie dans les établissements de santé français et européens et les impératifs de sécurité autour de son utilisation. Les concepts de base de la chirurgie orthognathique ainsi que la valeur ajoutée offerte par la fabrication additive dans ce contexte font l'objet de sections dédiées.

La pertinence de mettre en place une chaîne de production par impression 3D en interne dans un établissement de santé est examinée en détail, en présentant les avantages et les contraintes associés à une telle démarche.

Enfin l'ouvrage s'intéresse à un cas d'usage pratique : le projet d'impression 3D mené par un hôpital universitaire français dans l'optique d'une conformité avec le règlement européen. Ce projet en cours de déploiement associe la planification internalisée de chirurgies orthognathiques par conception assistée par ordinateur avec la production sur site de gouttières occlusales adaptées au patient, au sein du service de chirurgie maxillo-faciale du CHU de Nantes.