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Long-term biocompatibility of a miniature stimulator implanted in feline hind limb muscles

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4 Author(s)
Cameron, T. ; Adv. Neuromodulation Systems Inc., Allen, TX, USA ; Liinamaa, T.L. ; Loeb, G.E. ; Richmond, F.J.R.

Chronic foreign-body responses and muscular changes were examined following the implantation of active miniature stimulators into the hind limb muscles of cats for periods of up to three months. The radio-frequency (RF)-powered stimulators were injected into muscles through a 12-gauge hypodermic needle. The tissue responses around the active stimulators were compared histologically to those provoked by passive devices, broken glass, silicone tubing, polyester suture material coated with polybutylate, and two of the internal components of the stimulator (ferrite, integrated circuit chip). Active and passive stimulators produced similar, benign foreign-body reactions that resulted in an essentially identical fibrous capsule over time. The responses were similar to those produced by the internal components and the suture material, and were more modest than those produced by the broken glass. The capsule did not appear to interfere with the functionality of active devices because thresholds measured during the post-implantation survival period did not change significantly over time. Unexpectedly, the severity of the reaction differed significantly amongst the various target muscles. Medial gastrocnemius exhibited the most severe response, whereas tibialis anterior had the least reaction.

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Biomedical Engineering, IEEE Transactions on  (Volume:45 ,  Issue: 8 )