Biomedical

Applications of
Polyurethanes: Implications of
Failure Mechanisms

R. E. PHILLIPS, PH.D. AND M. C. SMITH, B.S.

Intermedics, Inc
4000 Technology Blvd.
Angleton, Texas 77515

R. J. Thoma, PH.D.
Carbomedics, Inc
Austin, Texas 78752

ABSTRACT

Three mechanisms have been described which explain various observed in-
teractions between polyurethane chemistry and body chemistry. These include
calcification, environmental stress cracking, and chain scission. Each may
result in implant device failure, and each appears to involve metal ion complex-
ation as a key parameter. Continued expansion of polyurethane into implant-
able product applications will require further clarification of the effect of each
of these interactions on long-term product performance. It is believed that
design considerations and polymer modifications will help control the effects of
each of the interactions and will result in new and improved polyurethane im-
plant products.
KEY WORDS

Polyurethane, calcification, environmental stress cracking, chain scission,

metal ion complexation.

INTRODUCTION
.

Segmented pol3refher polyurethanes (PEU) demonstrate a unique

combinations of physical and mechanical properties which have

207
 208

resulted in their evaluation and commercial use in implant applica-

tions. These polyurethanes, due specifically to their polymer chemistry,
’
exhibit good strength properties and excellent flex fatigue resistance.
An additional benefit of their chemistry is the relative biocompatibility
of this family of polymers [1-3]. Implant applications in which PEU
has found a commercial interest, and a degree of success, include insu-
lation of pacemaker leads, heart bladders for the total artificial heart
and left ventricular assist device, blood filters, and some types of cathe-
ters. Other applications in which PEUs are being evaluated include
heart valves and intravascular devices.
Even though the biocompatibility of PEUs is believed adequate for
long-term implant, there has been and continues to be technical ques-
tions about the biostability of these materials. Based on work con-
ducted in an attempt to understand the biostability issue more clearly,
specifically with reference to pacemaker leads, it is now clear that
PEUs are susceptible to body chemistry interactions which may affect
the longevity of this material in implant applications.
Three degradation pathways have been discussed which are believed
to explain a variety of body fluid-polymer chemistry interactions
known to be problematic in some long-term implant applications. The
three pathways include calcification [4,5], environmental stress crack-
ing [6], and chain scission [7]. It is the intent of this paper to review
these three processes, emphasizing their similarity and/or dissimilar-
ity, how product design may play a role in each, and the effect each may
’

have on device performance.

FAILURE MECHANISM

Calcification

The development of calcium hydroxyapatite mineral in or on the sur-

face of an implanted device or substrate is known as calcification. This
phenomenon has been observed in a number of implant products in-
cluding tissue [8] and polyurethane heart valves [5] and artificial heart
-

bladders [4]. In each application, calcification can lead to product fail-

urge due to polyurethane valve or bladder stiffening or tearing caused
by the mineral build up, especially in the zones of highest stress.
Much of the work to date to define the calcification mechanism for im-
plant products discusses the formation of thrombi or the deposition of
cells on the implant substrate as a possible sight for calcium phosphate
deposition [9,10]. In other words, the calcification mechanism is
believed to be driven by body fluid chemistry with minimal influence
 209

for the substrate. However, our own work has led us to hypothesize a
separate mechanism which may play an important role in the in vivo
deposition of calcium hydroxyapatite on and within the surface of poly-
urethane and other implant products. Polyurethanes can selectively ex-
tract metal ions from solution via complex formation with the poly-
ether soft segment [11]. Simple extraction studies between toluenic
solutions of polyether soft segment and aqueous solutions of metal ion
as well as surface (EDX) analysis of explanted polyurethane from im-

plant experiences from both humans and animals support the metal
complexation hypothesis [12).
The complex is thought to be formed in a coil-like structure between
the partially negatively charged soft segment oxygens and the posi-
tively charged metal ion, much like the ion selective complexing
strength demonstrated by crown ethers [13]. Molecular models of a
polyether urethane molecule compared with an 18-crown-6 cyclic ether
are shown in Figure 1. One can compare the ring in which ions are com-

plexed by the crown ether, and a similar coiled conformation the poly-
ether soft segment of polyurethane may attain. This chelation mecha-
nism was described by Hamon et al. who concluded that polyether soft
segment coiling played a key role in complex formation [14].
Earlier studies also confirm that calcium can be selectively com-
plexed with polyurethane’s soft segment, in particular the polytetra-
methylene glycol moiety (molecular weight of 1000) used in most com-
mercially available, implant grade polyether urethanes. Based on these
facts, we have. hypothesized that a calcification mechanism exists
which is driven by the substrate polyurethane chemistry. This mecha-

Figure la. Molecular model of an 18 crown 6 cyclic ether.

210

Figure lb. Molecular model of urethane. PTMEG-phcnyl isocyanate.

nism consists of a stepwise series of events initiated by calcium ion

complexation on and within the surface of the PEU substrate. The com-
plex formation, we believe, leads to increased calcium concentration in
the substrate, followed by phosphate deposition and hydroxyapatite for-
mation.
As mentioned above, mineralization in this manner of the polyure-
thane substrate of an.implantable device such as a valve or artificial
heart bladder may result in product failure. We believe that in order to
continue to use the strength and flex fatigue properties of PEU in ap-
plications such as these which require long-term flex stressing, it will
be necessary to control the calcium complexing step in the PEU calcifi-
cation process. This control may be obtained through PEU chemistry
modifications which minimize or interfere with calcium complex for-
mation.
’

Environmental Stress Cracking

Segmented PEUs are known to be susceptible to a crack forming and
propagating process known as environmental stress cracking (ESC).
This process requires the direct interaction of three variables including
a sensitive material, a reactive chemical media, and tensile stress,
before crack propagation may take place (Figure 2). Stokes et al. have
clearly demonstrated PEUs susceptibility to stress cracking [6,15].
This polymer cracking mechanism is believed to be the specific cause of
the early in vivo failure of specific models of polyurethane leads where
polyurethane was used as the lead coil wire insulator [6,15-17]..
 Figure 2. Environmental stress cracking.

Figure 3. Frosted surface of explanted polyurethane tubing.

211
212

Figure 4. Surface microfissures.

These specific leads were designed in a &dquo;J&dquo; shape for use in the atrial
chamber of the heart. ’fb maintain the &dquo;<T’ shape after implant, a &dquo;U&dquo;
shaped memory coil was designed into the curved portion of the lead. It
was discovered that the insertion of this memory coil resulted in a very

tight, interference fit between the coil and polymer insulation. This in-
terference significantly increased the stress level in the curved &dquo;J&dquo; por-
tion of the lead. For ex vivo circumstances the strength and stress re-
sistance of the polyurethane was great enough to withstand the added
stress of the memory coil. However, after implant and some period of
body fluid contact, the polymer’s ability to resist the stress was re-
duced, allowing the added stress of the memory coil to be relieved
through crack initiation and propagation. In this specific product
design, the stress level on the polymer was high enough to result in
severe cracking and polyurethane insulation failure. These failures
were found only in the curved portion of this design where the excess
stress was present. Specific design and manufacturing technique differ-
ences between models and manufacturers of polyurethane leads have
been described [18]. We believe that these differences account for most
of the significant polyurethane failure problems in pacing leads ob-
’

served to date.
Polyether urethanes are also known to exhibit surface microfissuring
after only a three to six month implant experience [19,20]. These micro-
fissures appear visually as a &dquo;frosted&dquo; area on an otherwise translucent
surface, and may appear even if no additional stress has been placed on
the polymers (Figures 3 and 4). The depth of these surface fissures has
 213

been determined to be typically only 10-15 microns after three years of

implant history. This microfissure phenomena is also believed to be a
result of environmental stress cracking, due to residual polymer sur-
face stress which occurs during fabrication of the polymer device.
The formation of microfissures in the surface of polyurethane sub-
strates is related to the polyurethane backbone chemistry. It has been
found that the lower durometer grades of segmented PEU which con-
tain a higher percentage of the polyether soft segment are more suscep-
tible to ESC [15]. We believe this is true because the higher levels of
polyether result in lower tensile strength than the harder formulations
with less polyether. Therefore, the stress resistance of the softer, lower
durometer grades is decreased.
In addition, the interaction between the polymer chemistry and body
chemistry for polyurethane may be different between the softer and
harder versions. Ratner et al. demonstrated that the surface of a cast
PEU contains largely the soft segment moiety, with the hard segment
being excluded to a 20 A depth from the surface (21]. This may be exag-
gerated for the softer PEU formulations with higher polyether con-
tents. Body fluid contact of PEU may lead to fluid and ion uptake and
hypothesized ion chelation by the polyether soft segment rich surface
as described earlier. This interaction is believed to be more probable for
the softer PEU formulations.
Ion chelation of the soft segment is known to result in polymer stiff
ening, and, in some cases is suspected to lead to embrittlement due to
morphological changes in the soft segment [14]. Changes have been de-
scribed by Sung and Fraker via small angle x-ray analysis which in-
dicate that metal ions become involved with the polyether soft segment
moiety [22J. Any chain stiffening or embrittlement of the surface soft
segment chemistry may result in localized stress concentrations which
when combined with surface stress from the polymer fabrication pro-
cess, may be relieved through surface crack initiation and propagation.
It is apparent that for the successful use of PEU polymers which are
susceptible to ESC in implant product applications, control of the key
parameters affecting the ESC mechanism is required. The success of
polyurethanes as implant materials depends upon controlling stress in
the material from the polymer processing or product design steps, and
minimizing contact with chemicals other than those present from the
in vivo experience (such as specific metal ions which may be released
from the coil in a PEU pacing lead) which can accelerate the effect the
reactive chemical factor has on the polymer’s stress resistance. Also,
understanding how polyurethane’s polymer chemistry can affect its
sensitivity to ESC may play a role in polymer formulation choice. For
214

example the choice of Pellethane 2363 55D or ~coflex 60D may offer
less sensitivity to ESC because of their lower polyether content. How-
ever, design considerations relative to the higher hardness and stiff
ness that these polymer formulations demonstrate is as important to
the final implant product performance as is the ESC sensitivity.
If designers control the factors which affect ESC, then the use of the
softer, more flexible polyurethane compositions in product designs
requiring compliance and flexibility can be successful. Several manu-
facturers of pacemaker leads which are designed with the flexible Pel-
lethane 2363 80A or 90A grades have had no significant device perfor-
mance problems due to ESC, even though it is recognized that these

polymer formulations may be slightly more susceptible to this mech-

anism.
What is clear is that the more one understands the engineering lim-
its of the polyurethane materials available today for implant applica-
tion the easier it will be for polyurethane implant products to be
designed within these specific limits, thus insuring more reliable
device performance.

Chain Scission

A third degradation process for segmented PEU has been observed

and is currently under investigation by several researchers. This pro-
cess has resulted in she chain scission of the polyurethane polymer
backbone. Stokes et al. [7] have discussed the autooxidative degrada-
tion of the polyether soft segment moiety which is catalyzed by specific
metal ions, and results in oxidation and chain scission of the carbon-
oxygen bonds in the polyether. Hydrogen peroxide produced in vivo has
been suggested as a potential source of free radicals which could ini-
tiate the oxidation mechanism. A peroxide and metal ion driven degra-
dation mechanism, however, may not be the only possibility for the in
viuo observations. Our own analyses question the oxidative damage
possible from the hydrogen peroxide concentrations generated in vivo
even in the presence of metal ions such as silver which has been ob-
served to have a deleterious effect on specific polyurethane pacing leads
[23]. The degradation of polyurethane may indeed be oxidative in na-
ture, but may not require peroxide as the initiator. The specific metal
ions described as catalysts for oxidation may instead be coreactants.
In vitro testing using a pacemaker lead containing a conductor coil
with silver metal and simulating the pacing environment demon-
strated the susceptibility of polyurethane (Pellethane 2363 80A in this
experiment) to embrittlement without the presence of peroxide. After a
 215

Figure 5. FTIR of unimplanted Pellethane 2363 80A.

six week period of pacing in a 0.9% saline solution, the polymer insula-
tion had embrittled, resulting in insulation failure.
FTIR spectroscopy of this embrittled polymer demonstrated the same
polymer chemical changes found for in vitro (peroxide driven) and in vivo
failures in Stokes’ work [7]. The specific chemical changes due to the pac-
ing experiment are shown in Figures 5 and 6, the FTIR spectra of control
and embrittled polymer, respectively. Comparing these scans, the follow-
ing major changes are observed: sharpening of the N-H stretch band at
~ 3328 crri ’ may indicate hydrogen bonding with carbonyl; changes in
the CH, CH2 stretch at - 2850 cm-1; splitting of the carbonyl stretch peak
at 1730 cm-1 with the new peak at 1710 cm-’ indicating hydrogen bonded
carbonyl; reduction in the CH2 wag at -1370 cm-1; appearance of a new
peak at 1175 em-1 which we believe is an indication of a metal ion com-
plex with the polyether soft segment; and splitting of the C-O-C stretch
peak at -~ 1100 cm-1 which shows a reduction in the C-O-C of the polyol
0
I .

and clarification of the C-O-C stretch of the -C-4-C urethane

. ester bond.
All of these changes indicate chain scission via oxidation of the polyol
moiety. These specific FTIR spectral changes are also supportive of an
increased degree of hard segment which has been well defined by Chris-
tenson et al. in their analyses of model polyurethane compounds [24].
 Figure 6. FTIR of Pellethane 2363 80A. In vitro pacing experimental.

Figure 7. EDX of polyurethane from the in vitro experimental.

216
 217

The importance metal ions may play in the chain scission mechanism
is emphasized in EDX analyses of the embrittled polyurethane from
the in vitro experiment described earlier (Figure 7). The embrittled
area was found to contain a variety of metal ions from the coil wire
used in the experiment. The coil wire, known as DBS, is composed of
silver brazed MP35N wire (a nickel, cobalt, chrome, and molybdenum
alloy).
The metal ions appear to have been complexed by the polyether soft
segment as described earlier for calcification. The appearance of the
1175 cm-1 peak in the FTIR spectra after metal ion contact with poly-
urethane is indicative of complex formation. This is confirmed in a com-
parison of the infra red spectra for a polyether model, PTMEG 1000
(polytetramethylene glycol with a 1000 molecular weight) with the
same polyol which had been extracted with calcium ion (Figure 8). The
peak at 1175 cm-1 is clear in the calcium complexed polyol. Complexa-
tion of the soft segment in this manner may be required as the initiator
of an oxidative chain scission. Studies currently underway in our labo-
ratories indicate that metal ion complex formation in the presence of
chloride ion may be a sufficiently oxidative media to cleave the poly-
ether molecule [25]. This reactive media could explain the polymer em-
brittlement observed in the previously discussed in vitro study, and
could be expected to be present during the in vivo experience for pace-
maker leads.
To reemphasize a key point, the FTIR scans for in vitro and in vivo
samples demonstrating embrittlement are virtually identical. Perox-
ide is not required for the chain scission mechanism to proceed. This
fact is further supported by recent analyses of specific Intermedics co-
axial bipolar lead models which used silicone rubber as the outer, body
fluid contacting insulation and also used a thin Pellethane 2363 80A
polyurethane inner insulation (nominal wall thickness of 0.004 inch).
The design of such a coaxial device is detailed in Figure 9. Such a
design was found to have a higher incidence of product failure during
the implant experience than other Intermedics’ leads. Analyses of
returned product led to the conclusion that the inner, thin polyure-
thane insulation had embrittled in a manner similar to that described
above in specific locations believed to be areas of highest flex stress,
even though the outer silicone insulation was undamaged and no direct

pathway to body fluids existed to the inner polyurethane insulation.

We believe, therefore, that the opportunity for peroxide to be present in-
side these leads to initiate the polyurethane degradation was remote.
An example of the embrittlement observed from close inspection of
these specific leads is shown in Figure 10.
 0
0
0

L5
w
S
P,
0

E
t ’
0
Q.

o0
a:
00

u
a
E

218
<
u
+
0
0
0

0
w
S
~P.
0
0
s..

0.
rn

S
-3
00

s
9
b

219
220

Figure 9. Coaxial bipolar design.

FTIR of the embrittled area in these specific silicone bipolar leads

(Figure 11) is virtually identical to the FTIR scans from the in vitro
experiment in Figure 6, and to those from the in vivo experience
presented by Stokes [7]. Specific chemical changes due to embrittle-
ment are further demonstrated by comparing Figures 12 and 13, com-
puter enhanced spectra of the 1300-1000 cm-1’ region of the IR of a
cracked and an uncracked area of the same lead only centimeters
apart. The specific chemical differences again include the appearance
of the 1175 cm-1 peak and reduction of the C-4-C peak for the embrit-
tled polymer.
Molecular weight analysis verifies that molecular chain scission is
the cause of the polymer embrittlement of the inner polyurethane insu-
lation in the specific silicone bipolar leads described earlier. The molec-
ular weight of a cracked area was significantly lower than both an un-

Figure 10. Inner insulation from silicone bipolar lead.

 221

Figure 11. FTIR spectra of inner insulation.

cracked area in the lead and a retain sample of the same lot of
same

polyurethane tubing (Table 1). EDX of a similar cracked area again

demonstrated the involvement of metal ions from the coil wire, and also
shows the presence of chloride ions (Figure 14).
The data continue to support a chain scission mechanism which re-
quires direct metal ion involvement. We believe this involvement con-
sists of ion complexation of the polyether soft segment. We also believe
that chloride ion may play an important role in the chain scission
mechanism. As discussed for calcification, control of the ion complex-
ing process should eliminate PEU chain scission degradation and
should offer improved PEU device performance. ’Tb minimize ion in-
volvement in PEU inplant products, consideration should be given to
polymer chemistry modifications or, as for polyurethane insulated

Table 1. Molecular weight analyses of tubing.

 Figure 12. FTIR computer enhancement. Cracked inner insulation.

222
Figure 13. FTIR computer enhancement. Uncracked area.

223
224

Figure 14. EDX of cracked inner insulation.

pacemaker leads, product design changes to minimize metal ion con-

tact with the PEU substrate.

SUMMARY

Calcification, ESC, and chain scission are three degradative pro-

cesses being investigated to explain various polyurethane-body fluid
interactions. There appears to be a commonality between them in that
metal ion involvement may play an important role in each of the three
(Figure 15). Continuing use of polyurethane in the design of implant-

Figure 15. Metal ion commonality.

 225

able products will require knowledge of the metal ion involvement and
control of this factor by product design considerations and/or polymer
modifications to provide optimum, long-term device performance and
reliability. The knowledge gained from the work to further define the
parameters necessary to control the three pathways discussed herein
will continue to support the use of polyurethane in implant appli-
cations.
z

ACKNOWLEDGEMENTS

The authors would like to acknowledge the analytical support of Tim

Hutson, Battelle Laboratories who provided the FTIR analyses and Dr.
Sam Sawan of the University of Lowell who provided the GPC molecu-
lar weight analyses.

REFERENCES

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thanes : a Polyether Polymer. II. Two Years’ Experience," J. Biomed. Mater.
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3. Lelah, M. D. and S. L. Cooper. Polyurethanes in Medicine. Boca Raton, FL:
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textured Implantable Blood Pumps;’ Trans. Am. Soc. Artif. Intern. Organs,
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thanes : A Proposed Mechanism for Calcification," in Polyurethanes in Bio-
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Pacemaker Lead Insulation Oxidation," J. of Biomed. Mater. Res., 21:525
(1987).
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 227

ABOUT THE AUTHOR

.

R. E. Phillips is Manager of Pacemaker Leads and Materials Engi-

neering for Intermedics, Inc., a manufacturer of implantable medical
products which include heart pacemakers, pacemaker leads, mechani-
cal heart valve components, orthopedic joint replacements and human
bone replacement materials. His responsibilities include the design of
new pacemaker lead products, biomaterials research involving polyure-
thane and other implantable materials, plus manufacturing support.
He is also a teaching participant in Intermedics accredited Physicians
Educational Program
Dr. Phillips has over seventeen years industrial experience in poly-
mer research and development, marketing technical support, and qual-

ity assurance in commodity and engineering thermoplastics, and most

recently, biomaterials and implantable devices. He has several patents
and publications in polymer technology. Current research has led to
the identification of a mechanism which may help explain how certain
implantable biomaterials calcify during the implant experience.
Dr. Phillips received his B.S. in Chemistry from Southwest Texans
University and his M.S. and Ph.D. in Chemistry (organic and biochem-
istry) from the University of New Mexico. He is a member of the Ameri-
can Cancer Society, the Society of Plastics Engineers, and the Society
for Biomaterials.