[ad_1]
Benny David, PhD., Director of business development, NuSil, speaks to Med-Tech Innovation News about the new possibilities that in situ care silicones can offer medical devices.
What types of applications use medical silicone and why is it attractive for use in implantable medical devices?
Medical silicones have a long and proven track record of use in healthcare applications. Every day around the world, this biomaterial is used in everything from soft silicone adhesives used in wound care products to components of medical devices implanted in the human body. Today, silicone can be found in applications such as cardiovascular pacemakers, cochlear implants, drug delivery devices, joint replacements, and intraocular lenses. Silicone is attractive in medical devices due to the polymer stability of the materials. They are also chemically inert, biocompatible and easy to clean and sterilize. Silicone formulations are highly customizable, allowing them to be tailored to the critical needs of a variety of applications.
What possibilities do in situ curing silicones offer for implantable medical devices?
In situ curing silicones bring personalized medicine to implantable devices. Normally, these devices are formed, cured and sterilized outside the body prior to the implantation procedure. NuSils’ patented delivery system provides an alternative to surgical implant by allowing uncured, pre-sterilized silicone to be delivered directly into the body, right where the device is needed. Silicone takes the shape of the implant site rather than a universal approach with standard implant shapes. Once delivered, the silicone cures in situ at body temperature.
The result is a real-time implant that creates opportunities for new personalized therapies that require less invasive implant procedures. It offers application potential for cardiovascular, neurological, urological and ophthalmic aesthetic implants. For example, in situ cured silicones could be used in a custom device for bone and spinal repair.
What challenges did you face in developing this technology?
The challenge was to find a way to package both uncured silicone and sterilization chemistry in a safe, all-in-one delivery system. The solution is a pre-filled dual cartridge dispensing technology. Each cartridge contains a gas permeable plunger seal that allows an ethylene oxide (EtO) sterilizing gas to permeate the seal and sterilize the uncured silicone inside the barrel. The silicone is then delivered directly to where the implant is needed.
How are in situ curing silicones developed?
An extremely versatile material, the chemical makeup of silicones can be fine-tuned to match specific properties of the material, including durometer, elasticity, and fatigue resistance. We work closely with customers to ensure that the in-situ cured silicone meets their requirements and functions as intended. For example, hardness can be precisely defined in a silicone device intended to provide orthopedic support; Similarly, an in situ cured silicone implant used to cushion a joint can be formulated for a specific level of softness.
Is this technology specific for long-term implants?
Yes, NuSils in situ care technology is for long-term implant devices (more than 29 days). Like all of our medical grade silicones, silicone is formulated, manufactured and purified to meet the most stringent regulatory requirements. We maintain more than 700 Master Files (MAFs) with the US Food and Drug Administration and are able to provide the relevant regulatory support needed to facilitate the path to commercialization.
What benefits do you think NuSil offers that would otherwise not be available?
For over 40 years, we have helped advance innovation and discovery. Whether it’s developing silicones for medical devices or for spacecraft traveling to Mars, we bring innovation and manufacturing expertise to every project. NuSil can provide ready-to-use medical grade silicones and custom formulations that meet precise process and device performance requirements. Our team knows how to move a silicone component or device from design to full-scale production.
What further progress do you anticipate in this particular area?
We expect to continue to see in situ care technology enabling new therapies that would not have been possible without this innovation in applications that could include orthopedic, cardiovascular, aesthetic or neurological therapies. For example, recent advances in the field of extended-release drug delivery are incorporating long-term implants that leverage in-situ care technology.
[ad_2]
picture credit