Abstract
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.
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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(2):026010–026026
Brindley G (1994) The first 500 patients with sacral anterior root stimulator implants: general description. Paraplegia 32(312):795–805
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(10):1076–1083
De Castro ML, Morales MJ, Martínez-Olmos MA, Pineda JR, Cid L, Estévez 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(9):529–536
Deb S, Tang SJ, Abell TL, Rao S, Huang WD, Lahr C, Chiao JC (2012) An endoscopic wireless gastrostimulator (with video). Gastrointest Endosc 75(2):411–415
Donaldson NN, Donaldson PEK (2000) Speeding-up the cure of one-part silicone rubber, when encapsulating neurological prostheses : the permeable mould. Med Eng Phys 22:301–306
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
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(2):103–107
Donaldson PEK (1995) Aspects of silicone rubber as encapsulant for neurological prostheses. Part 3: adhesion to mixed oxides. Med Biol Eng Comput 33(5):725–727
Donaldson PEK (1997) Aspects of silicone rubber as encapsulant for neurological prostheses. Part 4: two-part rubbers. Med Biol Eng Comput 35:283–286
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(3):289–292
Donaldson PEK, Sayer E (1981) A technology for implantable hermetic packages. Part 2: an implementation. Med Biol Eng Comput 19(4):403–405
Espinet-Coll E, Nebreda-Durán J, Gómez-Valero JA, Muñoz-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(2):72–87
Evans JT, DeLegge MH (2011) Intragastric balloon therapy in the management of obesity: why the bad wrap? J Parenter Enteral Nutr 35(1):25–31
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(9765):557–567
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–control study on complications, tolerance, and efficacy. Obes Surg 23(7):953–958
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(26):6109–6118
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(9781):1938–1947
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(3):229–243
Herron DM, Birkett DH, Thompson CC, Bessler M, Swanström LL (2008) Gastric bypass pouch and stoma reduction using a transoral endoscopic anchor placement system: a feasibility study. Surg Endosc 22(4):1093–1099
Ibrahim M, Blero D, Deviere J (2010) Endoscopic options for the treatment of obesity. Gastroenterology 138(7):2228–2232
Jiang G, Zhou DD (2010) Technology advances and challenges in hermetic packaging for implantable medical devices. In: Zhou DD, Greenbaum E (eds) Implantable neural prostheses 2. Biological and medical physics, biomedical engineering. Springer, New York, pp 27–61
Krames ES, Hunter Peckham P, Rezai AR (2009) Neuromodulation. Academic Press, Elsevier
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
Lonys L, Hiernaux M, Cauche N, Devière 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
Nelson WB (1982) Applied life data analysis. Wiley, Hoboken
Nusil (2012) Avoiding inhibition when working with platinum catalyzed silicones. p 9905
Roman S, Napoléon B, Mion F, Bory R-M, Guyot P, D’Horazio H, Benchetrit S (2004) Intragastric balloon for “non-morbid” obesity: a retrospective evaluation of tolerance and efficacy. Obes Surg 14(4):539–544
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(1):290–300
Scholz F (2008) Inference for the Weibull distribution. http://www.stat.washington.edu/fritz/DATAFILES498B2008/WeibullBounds.pdf. Accessed 7 Aug 2013
Silimed (2010) Instruction for use: gastric balloon. http://medikell.hu/uploads/images/file/INSTRUCTIONS%20FOR%20USE.pdf. Accessed 1 Sept 2014
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(2):63–68
Traeger RK, Sandia L (1977) Nonhermeticity of polymeric lid sealants. IEEE Trans Parts Hybrids Packag 13(2):147–152
Trudel J, Gauderer MWL, Drews MJ, LaBerge M (1998) Lipid uptake by silicone enteral access feeding devices. J Pediatr Surg 33(6):880–884
Vanhoestenberghe A, Donaldson N (2013) Corrosion of silicon integrated circuits and lifetime predictions in implantable electronic devices. J Neural Eng 10(3):1002–1015
Vanhoestenberghe A, Donaldson N (2011) The limits of hermeticity test methods for micropackages. Artif Organs 35(3):242–244
Williams DF (1982) Biodegradation of surgical polymers. J Mater Sci 17:1233–1246
Withrow D, Alter DA (2011) The economic burden of obesity worldwide: a systematic review of the direct costs of obesity. Obes Rev 12(2):131–141
Yap Kannan R, Nutt MR (2013) Are intra-gastric adjustable balloon system safe? A case series. Int J Surg Case Rep 4(10):936–938
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(2):115–128
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 3109–3114
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 1–42
Acknowledgments
The authors would like to acknowledge Mr. Bruno Tartini and Mr. Geoffrey Vanbienne for their contribution to the lap-shear tests.
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Lonys, L., Vanhoestenberghe, A., Julémont, N. et al. Silicone rubber encapsulation for an endoscopically implantable gastrostimulator. Med Biol Eng Comput 53, 319–329 (2015). https://doi.org/10.1007/s11517-014-1236-9
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DOI: https://doi.org/10.1007/s11517-014-1236-9