Biomedical Engineering Reference
In-Depth Information
Figure 7.8
X-STOP
PEEK Interspinous Process
Distraction (IPD
) System explant.
Figure 7.10
Periprosthetic tissues from an X-STOP
PEEK Interspinous Process Distraction (IPD) explant
showing PEEK particulate debris and a mononuclear
response (macrophages predominate) in fibrovascular
tissues (WrighteGiemsa stain, original magnification
¼
200
).
performance of the PEEK devices. The determina-
tion of the material's response (material properties of
the implant material as defined in ASTM F561-05)
was not performed in our laboratory.
As might be expected, periprosthetic tissue samples
primarily consisted of dense fibrous and fibrovascular
connective tissues (ligamentous tissues and scar
tissues). Bone, cartilage, muscle, and other connective
tissues (fibrofatty connective tissues) were less
frequently observed. Metallic debris was infrequently
observed in the histology. PEEK polymeric debris was
observed in histology in a majority of the X-STOP
PEEK devices, as seen in
Figs 7.10 through 7.17
.
Interfacial tissues showed a good amount of PEEK
particulate debris in a lamellar (layered) distribution
as well as some metallic particulate debris in interfa-
cial fibrous connective tissues. A higher proportion of
particulate debris was observed at the periphery of the
tissue samples. As seen in
Figs 7.11 through 7.13
,
at higher magnification, a chronic inflammatory
response consisting primarily of macrophages was
observed in response to the PEEK particulate debris.
As seen in
Fig. 7.14
, and less frequently observed,
a multinuclear response with foreign body giant cells
was observed in other microscopic fields.
For all of the explant histology, approximately less
than 10 PEEK particles were observed that were
Figure 7.11
Periprosthetic tissues from an X-STOP
PEEK Interspinous Process Distraction (IPD) showing
intracellular PEEK particulate debris in periprosthetic
fibrovascular
Figure 7.9
X-STOP
PEEK Interspinous Process
Distraction (IPD
) System explant.
tissues (WrighteGiemsa stain, original
magnification
200
).
¼
