A sterilizable dual-cartridge dispensing system that can be prefilled with customized uncured liquid silicone rubber (LSR) has the potential to enable innovative new medical therapies, according to NuSil (Carpinteria, CA). The supplier of implantable silicones featured the patented technology at last week’s Medical Design & Manufacturing (MD&M) West event in Anaheim, CA.
The new system enables medical device manufacturers to create devices that can be cured after implantation rather than curing them outside the body and then implanting them. “This could enable new therapies that could not be done before because the device fits into the surrounding morphology,” Julie Cameron, Vice President, Business Development & Manufacturing, told PlasticsToday. Implantable devices with a custom fit could lead to less-invasive procedures, she added.
The packaging for the in situ curable LSRs features a prefilled double-cartridge dispensing system with a gas-permeable plunger seal. The permeability allows the ethylene oxide sterilant to penetrate the plunger seal and sterilize the contents of the cartridge.
Traditional methods used to sterilize cured silicone would affect the properties of uncured silicone, explained NuSil. Gamma and electron beam sterilization increase cross linking, thereby reducing flexibility, while dry heat and autoclave sterilization damage the packaging and impact workability. EtO sterilization maintains the integrity of both the uncured implantable silicone along with its packaging, said NuSil.
Disposable syringes are available in sizes ranging from 5 to 75 ml, and the packaging system is compatible with a variety of injection technologies and is engineered for use in complete surgical kits.
First adopters of the technology are currently in clinical trials, according to Cameron, and applications include neurology, cardiology, orthopedics and gynecology.