TECHNOLOGICAL INNOVATION FOR CORONARY STENTS Francesco Migliavacca
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1 LABORATORY OF BIOLOGICAL STRUCTURE MECHANICS TECHNOLOGICAL INNOVATION FOR CORONARY STENTS Francesco Migliavacca Erice, 1 maggio 2015 International School of Cardiac Surgery
2 Introduction Patent search Heart valve Stent Francesco Migliavacca Roma 26 Novembre 2009
3 Introduction Mechanical cardiac valves Francesco Migliavacca Roma 26 Novembre 2009
4 Introduzione Stent Francesco Migliavacca Roma 26 Novembre 2009
5 # patents technological trend Introduction Mechanical heart valves Patent heart valve tot US+EP ( ) technological trend of mechanical heart valves ( ) SCIENTIFIC RESEARCH TECHNOLOGICAL RESEARCH INDUSTRIAL RESEARCH Courtesy of : R. Pietrabissa years Francesco Migliavacca Roma 26 Novembre 2009
6 # patents Introduction Stent patents 7 F 5 F 2F? Size unexpanded stent bare self-ex DES absorbable model RISCIENTIFIC RESEARCH TECHNOLOGICAL RESEARCH INDUSTRIAL RESEARCH 4000? years Francesco Migliavacca Roma 26 Novembre 2009
7 stent history Francesco Migliavacca Roma 26 Novembre 2009
8 30 days after implant in porcine coronaries Mg stent SS stent Waksman R. Adjunctive therapy: Biodegradable stents: They do their job and disappear. J Invas Cardiol 2006; 18: 70)74. Francesco Migliavacca Roma 26 Novembre 2009
9 Stent requirements Market issues Design requirements Price Clinical requirements Manufacturing technologies Drug adhesion Flexibility Trackability Radiopacity MR visibility Scaffolding Material properties Resistance to fracture Biodegradability Francesco Migliavacca Roma 26 Novembre 2009
10 Francesco Migliavacca Roma 26 Novembre 2009 Drug eluting stents
11 Drug carrier Polymer (biodegradable or not biodegradable) Drug eluting stents Inflammatory reaction Stent Drug Francesco Migliavacca Roma 26 Novembre 2009
12 Drug eluting stents van der Giessen, et al. Marked Inflammatory Sequelae to Implantation of Biodegradable and Nonbiodegradable Polymers in Porcine Coronary Arteries Circulation. 1996;94: Francesco Migliavacca Roma 26 Novembre 2009
13 Drug eluting stents Virmani, et al. Localized Hypersensitivity and Late Coronary Thrombosis Secondary to a Sirolimus-Eluting Stent. Should We Be Cautious? Circulation. 2004;109: Francesco Migliavacca Roma 26 Novembre 2009
14 Drug carrier Polymer (biodegradable or not biodegradable) Drug eluting stents Inflammatory reaction Stent Regular Spacing between struts Conformability (minimal struts malapposition) Uniform and controlled drug release More drug in the blood stream than in the arterial wall Drug Francesco Migliavacca Roma 26 Novembre 2009
15 Drug eluting stents OCT Prati et al. European Heart Journal doi: /eurheartj/ehs095 Francesco Migliavacca Roma 26 Novembre 2009
16 Drug carrier Polymer (biodegradable or not biodegradable) Drug eluting stents Inflammatory reaction Stent Regular Spacing between struts Conformability (minimal struts malapposition) Uniform and controlled drug release More drug in the blood stream than in the arterial wall Drug Uniform and controlled drug release Toxicity Francesco Migliavacca Roma 26 Novembre 2009
17 Drug eluting stents LATE STENT THROMBOSIS Francesco Migliavacca Roma 26 Novembre 2009
18 Drug eluting stents Dauerman H, The Magic of Disappearing Stents J Am Coll Cardiol. 2011;58(15): Francesco Migliavacca Roma 26 Novembre 2009
19 Drug eluting stents Strut thickness of only 50/60 μm 100% Polymer-Free Drug Delivery Bio-resorbable Drug Matrix Sirolimus - Matrix Excipient: Probucol Source: Francesco Migliavacca Roma 26 Novembre 2009
20 bioresorbable stents Muramatsu et al. Progress in Treatment by Percutaneous Coronary Intervention: The Stent of the Future. Rev Esp Cardiol. 2013;66: Francesco Migliavacca Roma 26 Novembre 2009
21 bioresorbable stents Source: Francesco Migliavacca Roma 26 Novembre 2009
22 bioresorbable stents Source: Francesco Migliavacca Roma 26 Novembre 2009
23 Biodegradable stents BACKGROUND Use of simulations for bioabsorbable stent to predict the mechanical behaviour of stent (recoil, radial strength, flexibility, ) to predict the degradation behaviour to optimise the design for a prolonged/shortened degradation resistance [email protected]
24 Biodegradable stents DEGRADABLE MATERIALS FOR STENTING Metals: Magnesium alloys Iron alloys Corrosion Degradation mechanisms Polymers: PLLA polycarbonate PLGA/PCL-PGA salicyclic acid polymer Bulk vs surface degradation Surface Degradation (lollipop) undegraded [Levesque et al 2008] Bulk Degradation (sponge) 24
25 Biodegradable stents MAGNESIUM ALLOYS STENTS Hansi et al, Cath Cardiovasc Interv, 73: , Bioresorbable Magnesium stent (BIOTRONIK, Berlin, Germany) [Erbel et al 2007] Degradation rate too fast!!! To improve corrosion resistance: alloying mechanical/heat treatments surface modifications and coatings TARGET: Degradation rate has to be reduced to ensure mechanical support to the vessel for a longer time 25 [email protected]
26 Stress Biodegradable stents MECHANICAL PROPERTIES OF MATERIALS FOR STENTS Material Stiffness E [GPa] yield stress σ y [MP] ultimate stress σ u [MP] Co-Cr Fe SS 316L WE PLLA 2-45 Strain 26 [email protected]
![GEOMETRY [Erbel et al 2007] 84476](/docs-images/26/8596593/images/27-0.png "elements C3D8R 27 francesco.")
27 Biodegradable stents AMS (Biotronik, Germany): 4 struts with links MG - GEOMETRY [Erbel et al 2007] elements C3D8R 27 [email protected]
28 Stress [MPa] D ext =4.2 mm D int =2.4 mm Biodegradable stents MODEL OF STENTING PROCEDURE coronary vessel 3 hyperelastic layers: s adventitia =0.34 mm s media =0.32 mm s intima =0.24 mm [Holzapfel et al 2005] C3D8R elements stent material Strain 28 [email protected]
29 Biodegradable stents RESULTS: DEGRADATION OF STENT STRUCTURE Uniform Corrosion: 48 t Stress Corrosion: 48 t Combined Corrosion: 48 t Stress 120 MPa Damage MPa 0 29 [email protected]
30 Biodegradable stents OPTIMISATION PROCEDURE 30
31 Biodegradable stents OPTIMISATION PROCEDURE strain original design optimized design Wu et al: FE shape optimization for biodegradable magnesium alloy stents Ann Biomed Eng,
32 Biodegradable stents OPTIMISATION PROCEDURE ZM21 original design optimized design 32
33 Biodegradable stents OPTIMISATION PROCEDURE 33
34 Biodegradable stents OPTIMISATION PROCEDURE strain AMS optimized 34
35 Late recoil Biodegradable stents DEGRADATION RESULTS ML/M i AMS magic optimized ott magic ott AMS magic optimized ott Time Time after 14 t corrosion 35 [email protected]
36 Biodegradable stents Two FEA models of MAS in the simulation of degradation Optimized design (OPT) Patent design as control (CON) The ratio of mass per length unit is 1.93 : 2.64 Ren et al., An Absorbable Implantation Stent of Magnesium Metal, Chinese patent, [email protected]
37 Biodegradable stents INTERACTION BETWEEN OPT MODEL AND VESSEL DURING DEGRADATION When the stent degraded the vessel recoiled until then stent broke 37
38 Biodegradable stents RESULTS AFTER STENT IMPLANTATION OPT CON The distribution of residual stress 38
39 Biodegradable stents UNIFORM AND STRESS CORROSION EVLUTION Uniform corrosion OPT CON Faster stress corrosion evolution 39
40 Biodegradable stents LASER CUTTING AND ELECTRO-POLISHING OF THE MAS SAMPLES OPT CON Material: AZ31 tube 40
41 Biodegradable stents DEGRADATION EXPERIMENT OF THE TWO SAMPLES The two samples were crimped to 1.2 mm of outer diameter and expanded to 3.0 mm then recoiled freely. The expanded CON sample is shown below. The two expanded samples were immersed in the D-Hank s solution for 7 days, with ph 7.5 and and temperature 37 C. The two samples were observed with unaided eyes to check structural integrity when immersed in solution. Then they were taken out for the observation with stereo or scanning electron microscope (SEM) after 7 days of corrosion. 41 [email protected]
42 Biodegradable stents EXPERIMENTAL RESULTS: STRUCTURAL INTEGRITY After the first day of immersion, the CON sample had several broken points on the strut while the OPT sample kept the structural integrity until the third day of immersion. After 7 days of corrosion, the CON sample has scattered into pieces, while the OPT has not scattered even though it had several broken points. The result is compatible with simulation that the OPT model has better property to resist corrosion. OPT CON 42 [email protected]
43 Biodegradable stents EXPERIMENTAL RESULTS: UNIFORM AND STRESS CORROSION The SEM observation shows that corrosion layers caused by uniform corrosion, which were shedding from the stent matrix. The early broken points caused by stress corrosion can also be observed and are compatible with the expected location in simulation. 43
44 Biodegradable stents CONCLUSIONS FROM MATHEMATICAL MODELLING Both simulation and experiment indicated that the optimized MAS design can yield better property to resist corrosion. Both simulation and experiment showed that the degradation of MAS consists of uniform and stress corrosion. The experiment preliminarily verified that the proposed numerical approach can be an effective tool for novel MAS design and property comparisons. 44
45 In progress 45
46 Francesco Migliavacca Roma 26 Novembre 2009 Coronary bifurcation
47 Francesco Migliavacca Roma 26 Novembre 2009 different stent applications
48 # patents Introduction stent patents SCIENTIFIC RESEARCH TECHNOLOGICAL RESEARCH INDUSTRIAL RESEARCH 4000? Francesco Migliavacca Roma 26 Novembre years The optimal design, however, of scaffolds, polymers, antiproliferative drugs and their degradation/release kinetics is still under investigation.
49 Thank you Computational models presented here are carried out with the help of: Wei Wu Dario Gastaldi Lorenza Petrini Francesco Migliavacca Roma 26 Novembre 2009 LABORATORY OF BIOLOGICAL STRUCTURE MECHANICS
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