Case Studies - Bentec Medical

Biocompatability:

Through decades of use in medical applications, silicone has been demonstrated to be non-reactive with and non-irritating to human tissue and body fluids. Being soft to the touch, silicone offers comfort to patients, whether applied on or under the skin. Odorless and tasteless, silicone does not support bacteria growth and will not stain or corrode other materials. All of these characteristics have made silicone a material of choice for Class 1 to Class 3 medical devices, such as catheters, cochlear implants or aesthetic/reconstructive implants.

Thermal Stability:

Silicone maintains its critical mechanical and physical properties within defined design limits over a large range of temperatures. Depending on the exact nature of the silicone product, silicone will remain chemically stable within a range of -75°F to as high as +400°F. Among other advantages, this thermal stability makes silicone highly resistant to a variety of medical sterilization techniques through multiple sterilization cycles, including steam autoclaving and UV, β, γ and E-beam radiation.

Elastomeric Properties:

Silicone has high tear (to 250 ppi) and tensile(to 1500 psi) strength, good elongation (to 1250%) and flexibility, low compression set, and a durometer range of 5 to 80 Shore A. The softer forms of silicone have the ability to retain their softness indefinitely, with the softest durometers available in the form of reinforced gels.

Gas Permeability:

Silicone’s molecular chains contain openings that are large enough to allow gas molecules to passthrough, but not water molecules. This combination of water repellency and gas permeability facilitates coatings that are both water-resistant and breathable. These properties are useful in a variety of medical applications, including membranes for blood oxygenation, gas separation and drug delivery. Silicone can also be used in wound care dressings, for external prosthetic devices and in some types of contact lenses.

Electrically Insulative Properties:

With no free electrons available to carry a positive or negative charge, silicone exceeds all comparable materials in its insulating properties, as well as in its versatility for electrical applications. Silicone is generally nonconductive and can maintain dielectric strength in temperature extremes far higher or lower than those in which conventional insulating materials are able to perform, making it an ideal material to control the electric current in medical applications, such as pacemakers, defibrillators, tissue cauterization or continuous glucose monitoring.

Chemical Inertness:

Silicone exhibits low surface tension, low surface energy and low intermolecular interactions, causing it to remain stable and retain physical properties when mixed with water and many chemicals, including isopropyl alcohol. Silicone’s hydrophobicity and low surface tension result in high hemocompatibility and reduce the potential of encrustation when contacting various body fluids, making it useful in kidney dialysis, blood oxygenator, and heart valve applications. Silicone’s hydrophobicity also makes it an effective lubricious coating for surgical tools and syringes, simultaneously reducing both insertion force and a patient’s pain sensation.

Adhesive Properties:

Silicone is a great sealing solution for applications where high-strength elastic bonds between substrates are needed. This capability can be important in the assembly of medical devices, in which silicone components may need to be bonded with metal and/or thermoplastic components. These same properties add another medical application to silicone’s long list: skin adhesion. Used across wound care, medical tape, and transdermal drug delivery patch products, silicone adhesives provide a secure, yet gentle skin seal that can be removed without discomfort to the patient.

Low Thermal Conductivity:

Silicones generally have low thermal conductivity because the molecular structure of silicone tends to impede the transfer of heat vibrations from one molecule to the next. If this is an undesirable characteristic, thermally conductive fillers can be added to the silicone formulation to improve the heat transfer required for the intended application.

Versatility:

The Si-O polymer chain is very receptive to bonding with individual atoms or other molecules that contain a desired physical property or characteristic. If certain properties of silicone are attractive, but others aren’t, silicone can be reformulated at the molecular level to achieve the desired outcome.

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