Silicone rubber encapsulation for an endoscopically implantable gastrostimulator

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• 作者：Laurent Lonys (1)
  Anne Vanhoestenberghe (2)
  Nicolas Jul茅mont (1)
  St茅phane Godet (3)
  Marie-Paule Delplancke (3)
  Pierre Mathys (1)
  Antoine Nonclercq (1)
  
  1. Biomedical Stimulation and Monitoring Research Group (BISTIMO) ; Universit茅 Libre de Bruxelles ; Avenue F.D. Roosevelt 50 ; CP165/51 ; 1050 ; Brussels ; Belgium
  2. Implanted Devices Group ; Medical Physics and Bioengineering Department ; UCL ; Gower Street ; WC1E 6BT ; London ; UK
  3. Materials Engineering ; Characterization ; Synthesis and Recycling (4MAT) ; Universit茅 Libre de Bruxelles ; Avenue F.D. Roosevelt 50 ; CP165/63 ; 1050 ; Brussels ; Belgium
  
• 关键词：Gastric electrical stimulation ; Endoscopic implantation ; Obesity ; Encapsulation ; Packaging ; Lap ; shear test ; Silicone rubber ; Accelerated testing
• 刊名：Medical and Biological Engineering and Computing
• 出版年：2015
• 出版时间：April 2015
• 年：2015
• 卷：53
• 期：4
• 页码：319-329
• 全文大小：1,325 KB
• 参考文献：1. Borton, DA, Yin, M, Aceros, J, Nurmikko, A (2013) An implantable wireless neural interface for recording cortical circuit dynamics in moving primates. J Neural Eng 10: pp. 026010-026026 CrossRef
  2. Brindley, G (1994) The first 500 patients with sacral anterior root stimulator implants: general description. Paraplegia 32: pp. 795-805 CrossRef
  3. Cilluffo, T, Armstrong, D, Castiglione, F, Emde, C, Galeazzi, R, Gonvers, JJ, Blum, AL (1990) Reproducibility of ambulatory gastric pH recordings in the corpus and antrum. Scand J Gastroenterol 25: pp. 1076-1083 CrossRef
  4. Castro, ML, Morales, MJ, Mart铆nez-Olmos, MA, Pineda, JR, Cid, L, Est茅vez, P, Del-Campo, V, Rodriguez-Prada, JI (2013) Safety and effectiveness of gastric balloons associated with hypocaloric diet for the treatment of obesity. Rev Esp Enferm Dig 105: pp. 529-536 CrossRef
  5. Deb, S, Tang, SJ, Abell, TL, Rao, S, Huang, WD, Lahr, C, Chiao, JC (2012) An endoscopic wireless gastrostimulator (with video). Gastrointest Endosc 75: pp. 411-415 CrossRef
  6. Donaldson, NN, Donaldson, PEK (2000) Speeding-up the cure of one-part silicone rubber, when encapsulating neurological prostheses : the permeable mould. Med Eng Phys 22: pp. 301-306 CrossRef
  7. Donaldson PEK (1982) The underwater life of joints between adherend and adhesive materials useful in neurological prosthesis-making. In: Proceedings of international conference on Biomedical Polymers, Biological Engineering Society/Plastics & Rubber Institute, Durham, UK
  8. Donaldson, PEK (1994) Hydrothermal stability of joints, using a silicone robber adhesive, for a range of adherends of interest to makers of surgically-implanted microelectronic devices. Int J Adhes Adhes 14: pp. 103-107 CrossRef
  9. Donaldson, PEK (1995) Aspects of silicone rubber as encapsulant for neurological prostheses. Part 3: adhesion to mixed oxides. Med Biol Eng Comput 33: pp. 725-727 CrossRef
  10. Donaldson, PEK (1997) Aspects of silicone rubber as encapsulant for neurological prostheses. Part 4: two-part rubbers. Med Biol Eng Comput 35: pp. 283-286 CrossRef
  11. Donaldson, PEK, Aylett, BJ (1995) Aspects of silicone rubber as encapsulant for neurological prostheses. Part 2: adhesion to binary oxides. Med Biol Eng Comput 33: pp. 289-292
  12. Donaldson, PEK, Sayer, E (1981) A technology for implantable hermetic packages. Part 2: an implementation. Med Biol Eng Comput 19: pp. 403-405 CrossRef
  13. Espinet-Coll, E, Nebreda-Dur谩n, J, G贸mez-Valero, JA, Mu帽oz-Navas, M, Pujol-Gebelli, J, Vila-Lolo, C, Martinez-Gomez, A, Juan-Creix-Comamala, A (2012) Current endoscopic techniques in the treatment of obesity. Rev Esp Enferm Dig 104: pp. 72-87 CrossRef
  14. Evans, JT, DeLegge, MH (2011) Intragastric balloon therapy in the management of obesity: why the bad wrap?. J Parenter Enteral Nutr 35: pp. 25-31 CrossRef
  15. Finucane, MM, Stevens, G, Cowan, MJ, Danaei, G, Lin, JK, Paciorek, CJ, Singh, GM, Gutierrez, HR, Lu, Y, Bahalim, AN, Farzadfar, F, Riley, LM, Ezzati, M (2011) National, regional, and global trends in body-mass index since 1980: systematic analysis of health examination surveys and epidemiological studies with 960 country-years and 9.1 million participants. Lancet 377: pp. 557-567 CrossRef
  16. Genco, A, Dellepiane, D, Baglio, G, Cappelletti, F, Frangella, F, Maselli, R, Dante, MC, Camoirano, R, Lorenzo, M, Basso, N (2013) Adjustable intragastric balloon vs non-adjustable intragastric balloon: case鈥揷ontrol study on complications, tolerance, and efficacy. Obes Surg 23: pp. 953-958 CrossRef
  17. Green, RA, Guenther, T, Jeschke, C, Jaillon, A, Yu, JF, Dueck, WF, Lim, WW, Henderson, WC, Vanhoestenberghe, A, Lovell, NH, Suaning, GJ (2013) Integrated electrode and high density feedthrough system for chip-scaleoogle implantable devices. Biomaterials 34: pp. 6109-6118 CrossRef
  18. Harkema, S, Gerasimenko, Y, Hodes, J, Burdick, J, Angeli, C, Chen, Y, Ferraira, C, Willhite, A, Rejc, E, Grossman, RG, Edgerton, VR (2011) Effect of epidural stimulation of the lumbosacral spinal cord on voluntary movement, standing, and assisted stepping after motor complete paraplegia: a case study. Lancet 377: pp. 1938-1947 CrossRef
  19. Hasler, WL (2009) Methods of gastric electrical stimulation and pacing: a review of their benefits and mechanisms of action in gastroparesis and obesity. Neurogastroent Motil 21: pp. 229-243 CrossRef
  20. Herron, DM, Birkett, DH, Thompson, CC, Bessler, M, Swanstr枚m, LL (2008) Gastric bypass pouch and stoma reduction using a transoral endoscopic anchor placement system: a feasibility study. Surg Endosc 22: pp. 1093-1099 CrossRef
  21. Ibrahim, M, Blero, D, Deviere, J (2010) Endoscopic options for the treatment of obesity. Gastroenterology 138: pp. 2228-2232 CrossRef
  22. Jiang, G, Zhou, DD Technology advances and challenges in hermetic packaging for implantable medical devices. In: Zhou, DD, Greenbaum, E eds. (2010) Implantable neural prostheses 2. Biological and medical physics, biomedical engineering. Springer, New York, pp. 27-61
  23. Krames ES, Hunter Peckham P, Rezai AR (2009) Neuromodulation. Academic Press, Elsevier
  24. Lindberg M (2011) Case study: aging study of silicone materials in simulated gastric fluid. https://www.silicone-polymers.co.uk/pdf2011/Case%20Study-Aging%20Study%20of%20Silicone%20Materials%20in%20Simulated%20Gastric%20Fluid.pdf. Accessed 1 Sept 2014
  25. Lonys L, Hiernaux M, Cauche N, Devi猫re J, Vanhoest A, Mathys P, Nonclercq A (2011) Challenges for the design of an endoscopically implanted electrostimulator. In: Communication A, Machado P (eds) 16th Annual conference of the International Functional Electrical Stimulation Society, Atha Communication and Publishing Machado, Sao Paulo, Brazil
  26. Nelson, WB (1982) Applied life data analysis. Wiley, Hoboken CrossRef
  27. Nusil (2012) Avoiding inhibition when working with platinum catalyzed silicones. p 9905
  28. Roman, S, Napol茅on, B, Mion, F, Bory, R-M, Guyot, P, D鈥橦orazio, H, Benchetrit, S (2004) Intragastric balloon for 鈥渘on-morbid鈥?obesity: a retrospective evaluation of tolerance and efficacy. Obes Surg 14: pp. 539-544 CrossRef
  29. Rothermel, A, Liu, L, Aryan, NP, Fischer, M, Wuenschmann, J, Kibbel, S, Harscher, A (2009) A cmos chip with active pixel array and specific test features for subretinal implantation. IEEE J Solid-State Circuits 44: pp. 290-300 CrossRef
  30. Scholz F (2008) Inference for the Weibull distribution. http://www.stat.washington.edu/fritz/DATAFILES498B2008/WeibullBounds.pdf. Accessed 7 Aug 2013
  31. Silimed (2010) Instruction for use: gastric balloon. http://medikell.hu/uploads/images/file/INSTRUCTIONS%20FOR%20USE.pdf. Accessed 1 Sept 2014
  32. Subei, IM, Abdelazim, A, Bayoumi, A, Wahab, MA, Deriny, SE (1996) The effect of different types of intragastric balloons with and without a behavior modification program in morbid obesity. Saudi J Gastroenterol 2: pp. 63-68
  33. Traeger, RK, Sandia, L (1977) Nonhermeticity of polymeric lid sealants. IEEE Trans Parts Hybrids Packag 13: pp. 147-152 CrossRef
  34. Trudel, J, Gauderer, MWL, Drews, MJ, LaBerge, M (1998) Lipid uptake by silicone enteral access feeding devices. J Pediatr Surg 33: pp. 880-884 CrossRef
  35. Vanhoestenberghe, A, Donaldson, N (2013) Corrosion of silicon integrated circuits and lifetime predictions in implantable electronic devices. J Neural Eng 10: pp. 1002-1015 CrossRef
  36. Vanhoestenberghe, A, Donaldson, N (2011) The limits of hermeticity test methods for micropackages. Artif Organs 35: pp. 242-244 CrossRef
  37. Williams, DF (1982) Biodegradation of surgical polymers. J Mater Sci 17: pp. 1233-1246 CrossRef
  38. Withrow, D, Alter, DA (2011) The economic burden of obesity worldwide: a systematic review of the direct costs of obesity. Obes Rev 12: pp. 131-141 CrossRef
  39. Yap Kannan, R, Nutt, MR (2013) Are intra-gastric adjustable balloon system safe? A case series. Int J Surg Case Rep 4: pp. 936-938 CrossRef
  40. Yin, M, Borton, DA, Aceros, J (2013) A 100-channel hermetically sealed implantable device for chronic wireless neurosensing applications. IEEE Trans Biomed Circuits Syst 7: pp. 115-128 CrossRef
  41. Yin M, Li H, Bull C, Borton DA, Aceros J, Larson L, Nurmikko AV (2013) An externally head-mounted wireless neural recording device for laboratory animal research and possible human clinical use. Conf Proc IEEE Eng Med Biol Soc 3109鈥?114
  42. Zhou DD, Greenberg RJ (2009) Microelectronic visual prostheses. In: Zhou DD, Greenbaum E (eds) Implantable neural prostheses 1: devices and applications. Biological and medical physics, biomedical engineering. Springer, New York, pp 1鈥?2
  
• 刊物类别：Engineering
• 刊物主题：Biomedical Engineering
  Human Physiology
  Imaging and Radiology
  Computer Applications
  Neurosciences
  
• 出版者：Springer Berlin / Heidelberg
• ISSN：1741-0444

文摘

Gastrointestinal stimulator implants have recently shown positive results in treating obesity. However, the implantation currently requires an invasive surgical procedure. Endoscopy could be used to place the gastric stimulator in the stomach, hence avoiding the riskier surgery. The implant then needs to go through the oesophagus and be located inside the stomach, which imposes new design constraints, such as miniaturization and protecting the electronic circuit against the highly acidic environment of the stomach. We propose to protect the implant by encapsulation with silicone rubber. This paper lists the advantages of this method compared to the more usual approach of a hermetic enclosure and then presents a method to evaluate the underwater adhesive stability of six adhesive/substrate couples, using repeated lap-shear tests and an elevated temperature to accelerate the ageing process. The results for different adhesive/substrate couples tested, presented on probability plots, show that FR4 and alumina substrates with MED4-4220 silicone rubber are suitable for a first implantable prototype. We then compare these with the predicted lifetimes of bonds between historical standard silicone rubber DC3140 and different substrates and describe the encapsulation of our gastrostimulator.