Mise au point et évaluation de nouveaux revêtements de stents pour application cardio-vasculaire

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Submitted on 17 Jan 2018

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stents pour application cardio-vasculaire

Cecilia Delattre

To cite this version:

Cecilia Delattre. Mise au point et évaluation de nouveaux revêtements de stents pour application cardio-vasculaire. Autre. Université Sorbonne Paris Cité, 2015. Français. �NNT : 2015USPCD061�. �tel-01686255�

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Sommaire

REMERCIEMENTS i

SOMMAIRE iii

TABLE DES ILLUSTRATIONS vii

LISTE DES ABREVIATIONS ix

INTRODUCTION GENERALE 3

CHAPITRE 1 BIBLIOGRAPHIE 5

1.PROBLEMATIQUE CLINIQUE : LA STENOSE CORONAIRE 7

1.1.LES ARTERES CORONAIRES : QUELQUES ELEMENTS ANATOMIQUES ET PHYSIOLOGIQUES 7

1.2.LE TISSUS SANGUIN 8

1.3.LA PATHOLOGIE OBSTRUCTIVE DES ARTERES CORONAIRES OU STENOSE 10

2.PRISE EN CHARGE CLINIQUE 10

2.1.LE PONTAGE 10

2.2.L’ANGIOPLASTIE 11

2.3.LES LIMITATIONS DE CETTE TECHNIQUE 12

2.3.1. La resténose intra-stent 13

2.3.2. La thrombose tardive intra-stent 13

2.3.3. Infection sur prothèse 13

3.LES ENDOPROTHESES METALLIQUES OU « STENT » 14

3.1.LES PREMIERS STENTS 14

3.2.LES ALLIAGES CONSTITUANT LA STRUCTURE METALLIQUE 15

3.3.GEOMETRIE ET FLUX 18

3.4.PREMIERE GENERATION DE STENTS : LES STENTS NUS 20

3.5.DEUXIEME GENERATION DE STENTS 20

3.5.1. Les revêtements inorganiques 20

3.5.2. Revêtements actifs 21

3.6.STENTS ET RECHERCHES ACTUELLES 32

4. LE DEVELOPPEMENT D’UN DISPOSITIF MEDICAL IMPLANTABLE (DMI), ASPECTS

REGLEMENTAIRES 36 4.1.LE DM, DEFINITION 36 4.2.REGLEMENTATION 36 4.3.BIOCOMPATIBILITE 38 4.3.1. Définition 38 4.3.2. Évaluation in vitro 40 4.3.3. Évaluation in vivo 42 4.4.HEMOCOMPATIBILITE D’UN MATERIAU 44 4.4.1. L’hémostase 44 4.4.2. Les tests 46

5.DEVELOPPEMENT DE NOUVEAUX REVETEMENTS 47

5.1.COPOLYMERE DE DEXTRANE-POLY(BUTHYLE METHACRYLATE) 47

! ,7! 5.1.2. Le PBMA 47 5.1.3. La polymérisation radicalaire 47 5.2.RESULTATS PRELIMINAIRES 48 5.2.1. Caractérisation physico-chimique 49 5.2.2. Tests in vitro 50

6.BILAN ET MISE EN PERSPECTIVE 51

CHAPITRE 2 PARTIE EXPERIMENTALE 53

1.CADRE ET OBJECTIFS 55

2.MATERIELS ET METHODES 56

2.1.SYNTHESES ET MISE EN FORME DES POLYMERES 56

2.1.1. Matériel 56

2.1.2. La synthèse des polymères 56

2.1.3. Mise en forme des matériaux 58

2.2.CARACTERISATION PHYSICO-CHIMIQUE 59

2.2.1. Infrarouge à transformée de Fourier 59

2.2.2. Mesure d’angle de contact 60

2.2.3. Résistance du revêtement sous flux 60

2.3.EVALUATION IN VITRO 61

2.3.1. Adhésion bactérienne 61

2.3.2. Hémocompatibilité 61

2.3.3. Interactions avec les cellules circulantes 63

2.4.DELIVRANCE D’UN PRINCIPE ACTIF EX VIVO 65

2.4.1. Mise au point du système 65

2.4.2. Dosage du TAC libéré 65

2.5.EVALUATION IN VIVO 66

2.5.1. Implantation chez le rat 66

2.5.2. Modèle de resténose chez le lapin 67

2.5.3. Analyse des prélèvements 68

2.6.STATISTIQUES 69

3.RESULTATS ET DISCUSSION 70

3.1.SYNTHESES ET MISE EN FORME DES ECHANTILLONS 71

3.1.1. PBMA 71

3.1.2. Dex-PBMA et Dex-PBMA’ 71

3.1.3. Mise en forme 72

3.2.ETAPE 1 :SELECTION DU COPOLYMERE 73

3.2.1. Caractérisation 73

3.2.2. Réaction à corps étranger 75

3.3.ETAPE 2 :ANALYSE DU REVETEMENT DEX-PBMA 78

3.3.1. Caractérisations du copolymère retenu 79

3.3.2. Hémocompatibilité 81

3.3.3. Interactions avec les cellules circulantes 85

3.3.4. Dex-PBMA comme plateforme de libération de substances 87

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CHAPITRE 3 CONCLUSIONS 95

CHAPITRE 4 VALORISATION DES TRAVAUX DE THESE 101

1.PUBLICATION 103

2.PRESENTATIONS ORALE ET POSTER 117

2.1.PRINTEMPS DE LA CARDIOLOGIE 2013 117

2.2.JOURNEE DE L’ECOLE DOCTORALE GALILEE 2013 119

2.3.EUROPEAN CONFERENCE OF BIOMATERIALS 2013 120

2.4.PRINTEMPS DE LA CARDIOLOGIE 2014 122

3.ARTICLE DE PRESSE 124

REFERENCES 125

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Table des illustrations

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.7@>A:=4@2A7%;<7<>F68%

Introduction générale

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! S!

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!

Chapitre

1

(NF52@>8%P Q2C62A;>F5N28%

! !

Bibliographie

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5*1! /%)B%*1! 4A>A7F2>83% 1#+)! 1,)$0*1! W! &/! 1$%G/=*! -$! =Z$%! i^,.$%*!:kD! I&&*1! /&,4*+)*+)! &*! 4$1=&*! =/%-,/3$*D! "%*+/+)! +/,11/+=*! -/+1! &'/#%)*! )A#%/=,3$*! &'/%)B%*! =#%#+/,%*! ./$=A*! 1*!%/4,G,*!*+!&'/%)B%*!,+)*%7*+)%,=$&/,%*!/+)0%,*$%*!*)!*+!&'/%)B%*!=,%=#+G&*L*!*)!&/!-%#,)*! *+! &'/%)B%*! ,+)*%7*+)%,=$&/,%*! 2#1)0%,*$%*! *)! &'/%)B%*! %0)%#7*+)%,=$&/,%*D! 5*$%! =/&,(%*! 2%#L,4/&!*1)!-*!8!W!V!44D!

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