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InnoSeal*

InnoSeal is a biodegradable stretchy polysaccharide-based material that has been successfully tested as a sealant for large caliber vascular grafts (100% patency).  It is designed to be sufficiently tough and is sterilizable with a shelf life measured in years; however, when implanted in the body it degrades over a period of months and is replaced by living tissue. InnoSeal can be used with small caliber vascular grafts as well as be injected directly in the body as a bulking agent. 

This sealant was developed as a synthetic-replacement to animal-based sealants on the market, including collagen, albumen, and gelatin. The synthetic equivalent of these sealants will be valuable should countries begin to outlaw animal-based sealants that have the potential to carry prions for mad cow disease or which may cause allergic reactions in some people.

Quatromer®

Quatromer is a thermoset material and is designed to be injected into various cavities in the body. The viscous material is comprised of mainly PIB with active cyanoacrylate end-groups that, when mixed together with an activator, crosslink to form a solid, rubbery material. This material is similar to that used for racing car tires; however, it does not contain the vulcanizing agents used in rubber chemistry which are toxic in the body. 

Quatroset

This PIB-based thermoset material is injection-molded and then heat-cured to arrive at the final crosslinked product. The heat curing of Quatroset causes it to crosslink in three dimensions, which enhances its physical properties. Crosslinked PIB-based polymers will demonstrate minimal creep with time, thereby rendering them more desirable for load-bearing applications requiring memory, such as heart valves, vertebral disks, acetabular joints and menisci. 

SIBS (poly(styrene-b-isobutylene-b-styrene))**
YPK

The chemistry of the polyolefin triblock polymer, poly(Styrene-block-IsoButylene-block-Styrene), known as SIBS, relies on a backbone comprised of the molecule polyisobutylene (“PIB”) which gives SIBS its outstanding inertness and biocompatibility. Polyisobutylene alone is a gummy material; but, when styrene is attached to its molecular ends to form physical crosslinks, the gummy material becomes an elastomer. 

Physical Properties of SIBS:

Ultimate Tensile Strength (MPa)
10 - 25
Ultimate Elongation (%)
300 - 1100
Index of Refraction
1.525 - 1.535
Water Absorption (g/m2; at 24hr)
0.1 - 0.2
O2 Gas Perm ((x10-15)mol.m/m2.S.Pa)
0.4 - 0.6
Weight Average Molecular Weight
60,000 - 150,000
Polydispersity (Mw/Mn)
1.2 - 2.1


Results of materials (elastomers) submerged in boiling nitric acid (65% concentration):

Material
Result
Polyurethane
Degraded
Dacron
Degraded
Natural rubber
Degraded
Crosslinked PCU
Very Brittle
PEEKEK
Very Brittle
Silicone rubber
Very Brittle
Polyethylene LD
Very Brittle
Polypropylene
No Change
PMMA
No Change
Polystyrene
No Change
Teflon
No Change
SIBS 46A
No Change


BIOMATERIALS: Medical Applications of poly(styrene-b-isobutylene-b-styrene) ("SIBS")

* IP assigned to InnoGraft LLC.
** SIBS intellectual property is owned by Boston Scientific Corporation (BSC) and a license is required for its use. Innovia has been provided with licenses to manufacture and sell SIBS for various medical applications. BSC has a master file on SIBS at the FDA as it is approved for use on the TAXUS stent.

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