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Design of Biodegradable Esophageal Stents Mathias Peirlinck

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Design of Biodegradable Esophageal Stents Mathias Peirlinck Design of biodegradable esophageal stents Mathias Peirlinck Promotoren: prof. dr. ir. Benedict Verhegghe, prof. dr. Peter Dubruel Begeleiders: ir. Nic Debusschere, dr. Matthieu De Beule Masterproef ingediend tot het behalen van de academische graad van Master of Science in Biomedical Engineering Vakgroep Civiele Techniek Voorzitter: prof. dr. ir. Peter Troch Vakgroep Organische Chemie Voorzitter: prof. dr. José Martins Faculteit Ingenieurswetenschappen en Architectuur Academiejaar 2012-2013 Design of biodegradable esophageal stents Mathias Peirlinck Promotoren: prof. dr. ir. Benedict Verhegghe, prof. dr. Peter Dubruel Begeleiders: ir. Nic Debusschere, dr. Matthieu De Beule Masterproef ingediend tot het behalen van de academische graad van Master of Science in Biomedical Engineering Vakgroep Civiele Techniek Voorzitter: prof. dr. ir. Peter Troch Vakgroep Organische Chemie Voorzitter: prof. dr. José Martins Faculteit Ingenieurswetenschappen en Architectuur Academiejaar 2012-201 Preface This master dissertation forms the final chapter of my education in becoming a Biomedical Engineer. It has been a challenging 5 years with ups and downs, but I’m proud of what I have accomplished. The Master of Science in Biomedical Engineering intrigued me with fields like biomechanics, implants, regenerative medicine, biomedical devices, sensors and circuits. I chose this subject because the research area Nic Debusschere is currently working in seemed very interesting to me and I wanted to contribute. In this thesis, esophageal stenting is explored and the niche which bioresorbable stents can occupy within this field is postulated. As complaints or disappointments have risen on the insufficient radial force of contemporary biodegradable esophageal stents, there is still a lot of improvement to be made. For that reason, the stent’s chemical degradation is studied and a numerical framework of a (bioresorbable) polymeric braided wire stent is developed. This model can boost the development of an improved (bioresorbable) stent design, that can be trusted by both patient and doctor. The word ‘bioresorbable’ is put between brackets because the numerical framework will be extendable to all kinds of polymeric braided wire stents. This master dissertation wasn’t an individual merit, so first of all, to Nic and Matthieu De Beule: a big ‘thank you’ for all your guidance during this research. Your help and support guided me towards this final result. I like to thank Sandra Van Vlierberghe and Veerle Boterberg for their help in conducting a number of chemical analyses on both the non-degraded and degraded stent. I also want to thank Sander De Bock for helping me with my models in Abaqus (Dassault Systèmes, Providence USA). The geometrical modeling done in this thesis is founded on pyFormex and the BuMPer cluster allowed me to run extensive jobs in Abaqus. Without these tools, I wouldn’t have succeeded in developing a correct numerical framework, so I’m very grateful to prof Benedict Verhegghe for their development. I also like to thank prof. Dubruel and prof. Segers for their support and guidance. I am also thankful to Alexander Stamme from Ethicon for providing me the PDS sutures for comparison with the Ella BD stent. I also like to express my gratitude to professor Giani Dorta at the CHUV (university hospital) in Lausanne, where I went on Erasmus exchange, for taking some time out of his busy schedule to discuss the application of biodegradable stents in the esophagus with me. He pointed out why he was not convinced by the Ella BD stent, which motivated me to contribute to the development of a better design that could really put bioresorbable stents on the map of esophageal stenting. Last but not least and on a very personal note, ‘thank you Dad’. You made me who I am by your constant believe, trust and pride in me and my sister. Your years of fighting to live and to be able to stand next to me on my graduation day made you my personal hero. And although it won’t be possible to share that moment of my graduation physically anymore, I know you’re watching over me, with pride in your eyes. This thesis can be seen as a concrete application and extension of the research done by Matthieu De Beule and Nic Debusschere. Hopefully, the developed numerical model can really form a contribution in the development of better biodegradable esophageal stents. As in my opinion the model can be generalized to all kinds of biodegradable polymeric braided wire stents, I sincerely hope it can also serve beyond esophageal stenting. Mathias Peirlinck Gent, June 3 - 2013 ii The author and promoter give the permission to make this master dissertation available for consultation and to copy parts of this master dissertation for personal use. In the case of any other use, the limitations of the copyright have to be respected, in particular with regard to the obligation to state expressly the source when quoting results from this master dissertation Gent, June 2013 The promotors The supervisors The author Prof. dr. ir. Benedict Verhegghe Dr. ir. Matthieu De Beule Mathias Peirlinck Prof. dr. Peter Dubruel ir. Nic Debusschere Design of biodegradable esophageal stents By Mathias PEIRLINCK Masterproef ingediend tot het behalen van de academische graad van MASTER OF SCIENCE IN BIOMEDICAL ENGINEERING Academiejaar 2012-2013 Promotoren: prof. dr. ir. Benedict VERHEGGHE, prof. dr. Peter DUBRUEL Begeleiders: ir. Nic DEBUSSCHERE, dr. Matthieu DE BEULE Vakgroep Civiele Techniek Voorzitter: prof. dr. ir. Peter TROCH Vakgroep Organische Chemie Voorzitter: prof. dr. José MARTINS Faculteit Ingenieurswetenschappen en Architectuur Universiteit Gent Summary In this dissertation, a numerical framework to simulate the mechanical behavior of biodegradable (esophageal) polymeric braided wire stents is developed. The needed implementation of the steric interaction and friction between the wires is included in this model. Degradation studies on a polydioxanone stent and wires have been conducted to gain insight in the degradation mechanism of biodegradable aliphatic polyesters and its influence on the stent’s mechanics. Improvements to the current stent design are proposed and tested in a total esophageal stent deployment FEM simulation. Keywords Biodegradable esophageal stent – polymeric braided wire stent - finite element simulations – polydioxanone – degradation studies Design of Biodegradable Esophageal Stents Mathias Peirlinck Supervisors: ir. Nic Debusschere, dr. Matthieu De Beule Promotors: prof. dr. ir. Benedict Verhegghe, prof. dr. Peter Dubruel Abstract—In this article, a numerical framework to simulate The first bioresorbable esophageal stent has recently been the mechanical behavior of biodegradable (esophageal) introduced in Europe, the Ella BD stent, but complaints about polymeric braided wire stents is developed. This framework insufficient radial force and premature degradation includes the necessary implementation of the steric demonstrate the need for a better design. As analytical models interaction and friction between the wires. Degradation appear unable of capturing the mechanical behavior of studies on a polydioxanone stent and wires have been conducted to gain insight into the degradation mechanism of bioresorbable polymeric braided wire stents [1], a numerical biodegradable aliphatic polyesters and its influence on the model has to be developed. Since finite element modeling is an stent’s mechanics. Improvements to the current stent design important tool in the design of novel stents, such a model will are proposed and tested in a total esophageal stent be developed in this article. deployment FEM simulation. Keywords—Biodegradable esophageal stent, polymeric The Ella BD stent consists of polydioxanone-monofilaments braided wire stent, finite element simulations, degradation (PDS), the currently applied material for biodegradable sutures. studies, polydioxanone This polyester generally disintegrates by hydrolytic bulk degradation. I. Introduction 90 A wide variety of gastro-intestinal pathologies originate from 80 problems with the esophagus. Any malfunctioning of this organ 70 can easily lead to considerable discomfort and problems. Until 60 recently, esophageal stenting was only used as a palliative treatment to solve intraluminal obstruction or extrinsic 50 esophageal compression caused by malignant tumor(s), 40 esophageal strictures and/or perforations, trachea-esophageal fistula and gastro-esophageal anastomotic leaks. Partially and 30 Radial load (N) fully covered esophageal stents were developed to avoid tumor 20 ingrowth and to allow esophageal stenting to be used as a 10 possible temporary treatment for the above-mentioned pathologies. Migration problems and severe complication rates 0 (perforations, bleeding, chest pain, nausea, fistula, mal- 8 12 16 20 24 positioning, migration, …) and morbidity during stent removal Diameter (mm) however did not open up the list of indications for esophageal Degradation day 0 Degradation day 7 stenting. Up till today partially or fully covered self-expanding Degradation day 14 Degradation day 23 metallic or plastic stents (SEMS & SEPS) are not recommended Degradation day 35 Degradation day 37 or FDA approved for benign esophageal conditions. The quality Degradation day 48 Degradation day 56 of evidence for their use in those circumstances is very low and significant improvements in the design have to be made. Figure 1. Radial force during degradation Ella BD stent The Polyflex stent is the only exception as it is licensed in the US
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