Multimaterial Biocompatibility Question: Materials are all individually biocompatible

S

smorvan

#1
Hello,

We are developing an articulated extra-discal implant made from 3 materials which - if taken individually - are all biocompatible. Basically, our implant is made from the assembly of Part A, Part B and Part C. With Part A made from Material 1, Part B made from Material 2 and so forth.

We are struggling to prove that during normal operation (and under wear) the resulting debris are still biocompatible. And it does not make any sense for us to go after ISO 10993, since the material used are mutually amorphous to each other. For information, the materials we are talking about are PEEK, Titanium and PE.

A literature search does not yield much in terms of 'State of the Art' for the 3 materials, and some of the methods we are considering do not make any sense (perform a wear test in an ultrapure solution, characterize the molecules in there, synthesize the unknown molecule to perform an ISO 10993.

Any hints would be appreciated.

Thanks,
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
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#2
Re: Multimaterial Biocompatibility Question: Materials are all individually biocompat

Can any of the MEDDEV experts here help with this?
 
O

Outsider

#3
Re: Multimaterial Biocompatibility Question: Materials are all individually biocompat

This link may help in developing your test rationale and requirements in regards to the biocompatability of particles and debris the may be cast of during wear.

http://www.nanomedicine.com/NMIIA/15.4.3.5.htm

15.4.3.5 Foreign Body Granulomatous Reaction

As a general principle [1841], the human body reacts to insoluble foreign bodies placed within it either by extruding them (if they can be moved and an external wall is close at hand) or by walling them off by exactly the same process as wound granuloma formation* ...

Good luck,
Keith
 
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