308 ◾ The Guide to Entrepreneurship: How to Create Wealth for Your Company
e process by which Biomer
R
, Avcothane
R
, Pellethane
R
, and Tecoflex
R
have been shown to
un
dergo in vivo degradation phenomena is known as environmental stress cracking (ESC), or
mi
crocracking. Such microcracking can lead to catastrophic failures in surgically implan
ted
de
vices because the material weakens and eventually fractures. is ends all functionality of
th
e device.
PolyMedica scientists have developed a proprietary biostable polyurethane elastomer
wh
ich will not microcrack when used in vivo. is is an important advance which combines
th
e best attributes of previous polyurethanes and significantly advances polymer chemistry.
e
PolyMedica polyurethane has three important attributes. Firstly, it is a biostable polymer
wh
ich will not microcrack. Secondly, it is aliphatic and cannot form carcinogenic amines.
i
rdly, it is thermoplastic, so it can be processed by all conventional plastic manufacturing
tech
niques.
Confidential PolyMedica Industries, Inc. 22
Writing a Winning Business Plan ◾ 309
TABLE I
POLYMERS ACCEPTED FOR USE IN MEDICAL APPLICATIONS
PO
LYMER APPLICATION
Ac
rylics Hemostatic agents, bone replacement, corneas, facial prostheses
Ce
llulose acetate Nerve regeneration, packaging material
FI
uorocarbons Blood vessels, reconstructive surgery
Po
lyamides Syringes, blood transfusion sets, vascular implants
Po
lycarbonates Syringes, containers
Po
lyethylene Tubing, syringes, heart valves, knee joints
Po
lypropylene Syringes, implants, bones and joints
Po
lyurethanes Plastic surgery, biodegradable sutures, artificial hearts, catheters
Po
lyvinyl chloride Surgical tubing, blood collection and administration, blood vessel
sets
Si
licones Tubing, catheters, lubricants, tissue substitutes, heart and related
components
Confidential PolyMedica Industries, Inc.
310 ◾ The Guide to Entrepreneurship: How to Create Wealth for Your Company
TABLE II
CURRENT DEVICES AND THEIR COMPOSITION
DEVICE FUNCTION BIOMATERIAL IN USE
Artific
ial vitreous humorFill the vitreous cavity of the eyeSilicone, Teflon sponge, polyglycerylmethacrylate
(PGMA)
Co
rneal prostheses Provide an optical pathway to the
retina
Polymethylmethacrylate (PMMA), hydrogels
In
traocular lensCorrect problems caused by
cataracts
PMMA (lens), nylon, polypropylene, Pt, Ti, Au
loops
Artific
ial tear duct Correct chronic blockage PMMA
Artific
ial eustachian tube Provide clear ventilation passageSilicone rubber, Teflon
Ne
rve tubulation Align severed nerves Silicone membrane, porous surgical metals
Mi
ddle ear prostheses Replace diseased bones of the
middle ear
PMMA, metallic wire, Proplast (PTFE + carbon
fiber), Bioglass
Pe
rcutaneous leadsConduct power to electrical sensory
devices
Nylon or Dacron velour, PMMA
Au
ditory prostheses, visual
pro
stheses
Restoration of hearing and
vision
Pt and Pt-Ir wires and electrodes, Ta-TOa
2
O
5
electrodes, stainless steel, Elgiloy wires, silicone
rubber, PMMA
El
ectrical analgesiaEliminate chronic pain Same
El
ectrical control of
ep
ileptic seizure
Conduct electrical signals to
brain
Same
El
ectrophrenic stimulation Control breathing electrically Same
Bladder
control Stimulate bladder releaseSame
Confidential PolyMedica Industries, Inc.
Writing a Winning Business Plan ◾ 311
TABLE III
SYNTHETIC POLYMERS
PO
LYMER APPLICATION
Po
lyvinyl chlorid
eB
lood bags, bubble oxygenators,
oxygenator and dialysis tubing,
catheters
Po
lyethylene (high
mole
cular weight)
Orthopedic, acetabular cup
Po
lyethylene
te
rephthalate
Woven vascular prostheses, heart
valve suture rings
Po
lyacrylonitrile
(P
AN)
Dialysis membrane
Po
lytetrafluoroethylene
(T
eflonR TFE)
Orthopedic, coating stem prostheses,
coating tips, neurosurgery, aneurysm
clips
Po
lytetrafluoroethylene-
he
xafluoropropylene
copoly
mer (Teflon
R
FEP)
Orthopedics
Po
lycyanoacrylates Tissue adhesives
Po
lymethylmethacrylate Neurosurgery, cranioplasty,
orthopedics, grout for artificial
joints, opthamology lenses, contact
lenses, dental
Po
lyhydroxyethylmethacrylateAntithrombogenic surfaces, tubing,
plastic surgery, drug release,
contact lenses
Po
lydihydroxypropy1
me
thacrylate
Antithrombogenic surfaces, tubing,
plastic surgery, drug release,
contact lenses
Re
sin: diglycidyl
et
her of bisphenol A
(D
GEBA)
Packaging pacemakers, central
restorations
Confidential PolyMedica Industries, Inc.
312 ◾ The Guide to Entrepreneurship: How to Create Wealth for Your Company
TABLE III (continued)
SYNTHETIC POLYMERS
Po
lyurethanes Catheters, tubing, artificial
(s
egmented) heart ventricles, pumps
Po
lyglycolic acid Resorbable sutures
Si
licones Heart valves, tubing, plastic
surgery, oxygenators
Si
licone-polycarbonate Oxygenator membranes
copoly
mer
Co
polymer silicone- Left ventricular assist devices,
po
lyurethane (Avcothane
R
) intra-aortic balloon pumps
Po
lyphenoxy Oxygenator membranes
Po
lyamide (Nylon 6) Sutures
Po
lyformaldehyde Heart valve occluders,
(D
elrin
R
) general structural polymers
Epich
lorohydrin Flexible molds, impression material,
r
ubber (Hydrin
R
) dental applications
Po
lycarbonate General use oxygenator valve
(L
exan
R
) occluders, cranioplasty
Ce
llulose Dialysis membranes
Ce
llulose acetate Dialysis membranes
Po
lyalkylsulfone Membrane oxygenators
Po
lypropylene Syringes, catheters, oxygenators,
dialysis, heart valves, occluders,
sutures
Po
lyacrylic acid Dental cement
Gela
tin/resorcinol/ Tissue adhesive
fo
rmaldehyde
Po
lysulfide Dental impressions
r
ubber (mercaptan)
Confidential PolyMedica Industries, Inc.
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