Volume 44 Number 5 2007
Pages 723 — 738

Abstract - Porous composite prosthetic pylon for integration with skin and bone

Mark Pitkin, PhD;1-2* Grigory Raykhtsaum, MS;3 John Pilling, PhD;4 Oleg V. Galibin, MD, PhD;5 Mikhail V. Protasov, MD;5 Julie V. Chihovskaya, MD;5 Irina G . Belyaeva, MD, PhD;5 Miralda I. Blinova, PhD;6 Natalia M. Yudintseva;6 Igor L. Potokin, PhD;6 George P. Pinaev, PhD;6 Vladimir Moxson, PhD;7 Volodimir Duz, PhD7

1Tufts University, Boston, MA; 2Poly-Orth International, Sharon, MA; 3Leach & Garner Company, North Attleboro, MA; 4Materials Science and Engineering, Michigan Technological University, Houghton, MI; 5I. P. Pavlov State Medical University, St. Petersburg, Russia; 6Institute of Cytology, Russian Academy of Sciences, St. Petersburg, Russia; 7ADMA Products Inc, Hudson, OH

Abstract — This article presents results of the further development and testing of the "skin and bone integrated pylon" (SBIP-1) for percutaneous (through skin) connection of the residual bone with an external limb prosthesis. We investigated a composite structure (called the SBIP-2) made of titanium particles and fine wires using mathematical modeling and mechanical testing. Results showed that the strength of the pylon was comparable with that of anatomical bone. In vitro and in vivo animal studies on 30 rats showed that the reinforcement of the composite pylon did not compromise its previously shown capacity for inviting skin and bone cell ingrowth through the device. These findings provide evidence for the safe and reliable long-term percutaneous transfer of vital and therapeutic substances, signals, and necessary forces and moments from a prosthetic device to the body.

Key words: amputation, bone, cell ingrowth, mathematical modeling, mechanical testing, prosthesis, pylon, rehabilitation, residuum, skin, titanium.

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