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Design e stampa 3D di protesi personalizzate per la caviglia - Custom Endoprotesi


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Il progetto si inserisce nel campo della chirurgia personalizzata di precisione e in particolare nella realizzazione in stampa 3D di protesi in leghe metalliche e in polietilene per la chirurgia protesica sostitutiva (Custom-Endoprotesi).

Le superfici articolari affette da gravi degenerazioni sono sostituite da endoprotesi artificiali. L’attuale limitatissimo numero di taglie disponibili ingenera importanti problemi tra la protesi e l’osso ospitante, che porta spesso al fallimento della sostituzione. Con i nuovi strumenti a disposizione (immagini biomedicali, software di ricostruzione, modelli biomeccanici, ecc.) e la recente tecnologia di stampa-3D si vogliono progettare nuove protesi articolari personalizzate per la caviglia.

Principali settori indirizzati: Farmaceutico, biomedico, chimico, biologico, ingegneria tissutale, clinico

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Design e stampa 3D di protesi personalizzate per la caviglia - Custom Endoprotesi

  1. 1. 31/10/2017 1 Design e stampa 3D di protesi personalizzate per la caviglia Ing. Alberto LEARDINI, Ing. Claudio Belvedere, Ing. Paolo CARAVAGGI Laboratorio Analisi del Movimento Istituto Ortopedico Rizzoli CUSTOM IMPLANTS 2 Total Ankle Replacement Severe pain (*2M), end-stage osteoarthritis with motion limitation (*50K) AnkleFusion TotalAnkle Replacement (TAR) Both ankle fusion and current day TARs are inadequate in addressing the problem * NumbersrefertoUSA marketonly, notworldwide CUSTOM IMPLANTS 3 Total Ankle ReplacementGeneration: Pioneers ‘70 Classics ‘80 Modern ‘90 Current 2000 Smith ICLH Newton TPR Mayo TNK Agility Bue-Papp STAR ESKA AES Salto Alpha HintegraMobility TopezEclipse SaltoTal Taric CCIevol Cement fixation Bone resection Original CoR changed Osteolysis Impingement Loosening (90- 95%) Subsidence Infection Instability Edge loading Salvage/revision Malleolar fracture Polyethylene wear and dislocation Subsidence Instability Impingement Infection Vascularity Bone removal Syndesmosis fusion Non- delay-union Groove at articulat Long pegs, cortical window Screw-based fixation Stress-shielding Still Flat-Ti & Nat- Ta? Earlier complications Sizing Backto conforming 2-comp?! Lateral access?! Backto constrained?! Backto cement?! Cumbersome operative technique! Leardini et al. GIOT 2007; Giannini et al. Foot Ankle Surg 2000 CUSTOM IMPLANTS 4 Disegno anatomo-funzionale Plantarflexion DorsiflexionNeutral Post Ant Leardini Clin Biomech 2001; Med Bio Eng Comp 2001, 2002 CUSTOM IMPLANTS 5 Disegno anatomo-funzionale Max Do CaFi TiCa IC In 6 in-vitro implantation(‘99–’02), and in about1200patients (Jul ‘03– May‘16) Max Pl CUSTOM IMPLANTS 6 Disegno funzionale F CL CM B1 B2 A1 A 2 Lateral Sphere Medial Sphere Tibia/Fibula Segment Talus/Calcaneus Segment Fixed Sphere CaFiL TiCaL C Parenti-Castelli, Leardini et al., Med Bio Eng Comp 2007; J Biomech 2009 Two ligament fibres Three rigid contacts: A. 2 sph-pla at Ti-Ta, 1 sph-pla at Ta-Fi B. 3 sph-sph 3D mathematicaldescription of passivekinematics A B
  2. 2. 31/10/2017 2 CUSTOM IMPLANTS 7 Disegno funzionale CUSTOM IMPLANTS 8 Disegno anatomico • A new TAR design with articulating surfacegeometry representinga paradigm shift from the “Common knowledge”. 2. Lateralapex • Main features: 1. Truncated non-symmetriccone 3. Saddle shaped Claims, close to normal: • JointKinematics • Load Transfer • Loadingof ligaments • Behavior under functional and extremeloads Expectedbenefits: • Reduced wear • Reduced rates of failure CUSTOM IMPLANTS 9 Disegno anatomico Image- and experimental- based study of the morphology of the articular surfaces, in natural and prosthetic ankle joint CT Imaging Segmentation & 3D Renderings 3D Geometrical Analysis Design & Manufacturing ofArtificial Surfaces Testing: 3D Kinematics and Kinetics Analyses CAOS & EFAS Best Paper Awards!, June 2016ankles (vitro/vivo) CUSTOM IMPLANTS 10 Progettazione personalizzata Imaging Biomech.MODELS: anatomical Motion analysis funct/anat functional Bones Ligaments Kinematics D E S I G N D E S I G N d i m e s n e d Surgical/clinical options: •position •shoulder/gutter •fixationelements •material •cement/ coating •transverse plane •chamfers •insert •cutting blocks? D E S I G N f i n a l …modelling both ankles?! Liverani et al. Materials and Design 2016 CUSTOM IMPLANTS 11 Scansioni ed immagini Best selection, including possible combinations, among imaging devices at IOR: CT based tech: - Standard CT (no soft tissue) - Dual-Energy CT (enhancement of soft tissues) - ConeBeam CT (new technology, 3D and soft tissue, … loading!) MRI based tech: - 1.5 T MRI - 3.0 T MRI CUSTOM IMPLANTS 12 Scansioni ed immagini to create reference markers well detectable in CT & MRI via material combination rigidly fixed on relevant anatomical structures via plaster HARD MARKER with centered cavity…. ….Filled with a CRYSTAL JELLY BALL…. ….and hermetically closed to avoid possible drying.
  3. 3. 31/10/2017 3 CUSTOM IMPLANTS 13 Scansioni ed immagini Regular CT Tissue 1Regular CT Tissue 1 Dual Energy CT Basal 1Dual Energy CT Basal 1 MRI 3T T2 FSMRI 1.5T cartilage new CBCT CUSTOM IMPLANTS 14 Modellazione e registrazione CUSTOM IMPLANTS 15 Disegno e progettazione CUSTOM IMPLANTS 16 Disegno e progettazione CUSTOM IMPLANTS 17 Interfaccia impianto-osso Polyethylene component CUSTOM IMPLANTS 18 titolo Osseointegration Topography Chemistry& biocompatibility Bone-implant interface material Corematerial - metals (e.g. CoCr, Ti alloys, Mg alloys) - ceramics (Zr and Al based) - metals (CoCr, Ti alloy, Tantalum) - Calcium-phosphate based (biomimetic coating, e.g. hydroxyapatite) - surface roughness (10-50 micron) - micron-scale and nano-scale (1 – 100nm) - biotolerant (distance osteogenesis) - bioinert (contact osteogenesis) - bioreactive (stimulating bone ingrowth) Surface treatments - sand-blasting - plasma sprying - electropolishing “A direct structural and functional connection between ordered, living boneand the surface of a load-carrying implant.” Branemark (1985) Stress-shielding
  4. 4. 31/10/2017 4 CUSTOM IMPLANTS 19 Interfaccia impianto-osso CUSTOM IMPLANTS 20 CUSTOM IMPLANTS 21 ‘Trabecular bone model’ microCT– femoralbone TopviewSideview Density = 17% Trabecular thickness = 150um Trabecular Separation = 670um Acknowledgement : Laboratorio di Tecnologia Medica (IOR) CUSTOM IMPLANTS 22 Dal .STL al modello CrCo Selective Laser Melting CUSTOM IMPLANTS 23 Test tossicità e osteogenesi T0: 24 h T2: 2 weeks rounddiagonaltrabecularspherical top sidetop Acknolwedgement: laboratorio BITTA (IOR) CUSTOM IMPLANTS 24 Indagine SEM: campione “round”
  5. 5. 31/10/2017 5 CUSTOM IMPLANTS 25 Indagine SEM: campione “round” + cellule CUSTOM IMPLANTS 26 Indagine SEM: campione “trabecolare” CUSTOM IMPLANTS 27 Indagine SEM: campione “trabecolare” + cellule CUSTOM IMPLANTS 28 Prototipo di interfaccia impianto-osso: protesi di caviglia Selective Laser Melting (CIRI-MAM, UniBO) CUSTOM IMPLANTS 29 Sviluppi futuri … Cloud Services 3DP Fabrication! Specialised Research / Design Centre #i Specialised Research / Design Centre #N Specialised Research / Design Centre #1 T rad. Fabrication #1 T rad. Fabrication #N T rad. Fabrication #j CUSTOM IMPLANTS 30 Grazie per l’attenzione Ing. Alberto Leardini[] Ing. Claudio Belvedere [] Ing. Paolo Caravaggi[] Laboratorio AnalisidelMovimento,Istituto Ortopedico Rizzoli