Biomedical engineering (BME) or medical engineering is the application of engineering principles and design concepts to medicine and biology for healthcare applications. BME is also traditionally logical sciences to advance health care treatment, including diagnosis, monitoring, and therapy. Also included under the scope of a biomedical engineer is the management of current medical equipment in hospitals while adhering to relevant industry standards. This involves procurement, routine testing, preventive maintenance, and making equipment recommendations, a role also known as a Biomedical Equipment Technician (BMET) or as a clinical engineer.
![<span class="mw-page-title-main">Silicone</span> Family of polymers of the repeating form [R2Si–O–SiR2]](https://upload.wikimedia.org/wikipedia/commons/thumb/3/37/Caulking.jpg/320px-Caulking.jpg)
In organosilicon and polymer chemistry, a silicone or polysiloxane is a polymer composed of repeating units of siloxane. They are typically colorless oils or rubber-like substances. Silicones are used in sealants, adhesives, lubricants, medicine, cooking utensils, thermal insulation, and electrical insulation. Some common forms include silicone oil, grease, rubber, resin, and caulk.
In medicine, a catheter (/ˈkæθətər/) is a thin tube made from medical grade materials serving a broad range of functions. Catheters are medical devices that can be inserted in the body to treat diseases or perform a surgical procedure. Catheters are manufactured for specific applications, such as cardiovascular, urological, gastrointestinal, neurovascular and ophthalmic procedures. The process of inserting a catheter is called catheterization.
A menstrual cup is a menstrual hygiene device which is inserted into the vagina during menstruation. Its purpose is to collect menstrual fluid. Menstrual cups are made of elastomers. A properly-fitting menstrual cup seals against the vaginal walls, so tilting and inverting the body will not cause it to leak. It is impermeable and collects menstrual fluid, unlike tampons and menstrual pads, which absorb it.
Breast augmentation and augmentation mammoplasty is a cosmetic surgery technique using breast-implants and fat-graft mammoplasty techniques to increase the size, change the shape, and alter the texture of the breasts. Augmentation mammoplasty is applied to correct congenital defects of the breasts and the chest wall. As an elective cosmetic surgery, primary augmentation changes the aesthetics – of size, shape, and texture – of healthy breasts.
Radiodensity is opacity to the radio wave and X-ray portion of the electromagnetic spectrum: that is, the relative inability of those kinds of electromagnetic radiation to pass through a particular material. Radiolucency or hypodensity indicates greater passage to X-ray photons and is the analogue of transparency and translucency with visible light. Materials that inhibit the passage of electromagnetic radiation are called radiodense or radiopaque, while those that allow radiation to pass more freely are referred to as radiolucent. Radiopaque volumes of material have white appearance on radiographs, compared with the relatively darker appearance of radiolucent volumes. For example, on typical radiographs, bones look white or light gray (radiopaque), whereas muscle and skin look black or dark gray, being mostly invisible (radiolucent).
Medical gloves are disposable gloves used during medical examinations and procedures to help prevent cross-contamination between caregivers and patients. Medical gloves are made of different polymers including latex, nitrile rubber, polyvinyl chloride and neoprene; they come unpowdered, or powdered with corn starch to lubricate the gloves, making them easier to put on the hands.
The United States Federal Food, Drug, and Cosmetic Act is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics. The FDA's principal representative with members of congress during its drafting was Charles W. Crawford. A principal author of this law was Royal S. Copeland, a three-term U.S. senator from New York. In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs. The act has been amended many times, most recently to add requirements about bioterrorism preparations.
A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase.
Biocompatibility is related to the behavior of biomaterials in various contexts. The term refers to the ability of a material to perform with an appropriate host response in a specific situation. The ambiguity of the term reflects the ongoing development of insights into how biomaterials interact with the human body and eventually how those interactions determine the clinical success of a medical device. Modern medical devices and prostheses are often made of more than one material so it might not always be sufficient to talk about the biocompatibility of a specific material. Even the same materials, such as diamond-like carbon coatings, may show different levels of biocompatibility based on the manufacturing conditions and characteristics.
An implant is a medical device manufactured to replace a missing biological structure, support a damaged biological structure, or enhance an existing biological structure. For example, an implant may be a rod, used to strengthen weak bones. Medical implants are human-made devices, in contrast to a transplant, which is a transplanted biomedical tissue. The surface of implants that contact the body might be made of a biomedical material such as titanium, silicone, or apatite depending on what is the most functional. In 2018, for example, American Elements developed a nickel alloy powder for 3D printing robust, long-lasting, and biocompatible medical implants. In some cases implants contain electronics, e.g. artificial pacemaker and cochlear implants. Some implants are bioactive, such as subcutaneous drug delivery devices in the form of implantable pills or drug-eluting stents.
Polycaprolactone (PCL) is a synthetic, semi-crystalline, biodegradable polyester with a melting point of about 60 °C and a glass transition temperature of about −60 °C. The most common use of polycaprolactone is in the production of speciality polyurethanes. Polycaprolactones impart good resistance to water, oil, solvent and chlorine to the polyurethane produced.
Silicone rubber is an elastomer composed of silicone—itself a polymer—containing silicon together with carbon, hydrogen, and oxygen. Silicone rubbers are widely used in industry, and there are multiple formulations. Silicone rubbers are often one- or two-part polymers, and may contain fillers to improve properties or reduce cost. Silicone rubber is generally non-reactive, stable, and resistant to extreme environments and temperatures from −55 to 300 °C while still maintaining its useful properties. Due to these properties and its ease of manufacturing and shaping, silicone rubber can be found in a wide variety of products, including voltage line insulators; automotive applications; cooking, baking, and food storage products; apparel such as undergarments, sportswear, and footwear; electronics; medical devices and implants; and in home repair and hardware, in products such as silicone sealants.
A breast implant is a prosthesis used to change the size, shape, and contour of a person's breast. In reconstructive plastic surgery, breast implants can be placed to restore a natural looking breast following a mastectomy, to correct congenital defects and deformities of the chest wall or, cosmetically, to enlarge the appearance of the breast through breast augmentation surgery.
A drug-eluting stent (DES) is a tube made of a mesh-like material used to treat narrowed arteries in medical procedures both mechanically and pharmacologically. DES is inserted into a narrowed artery using a balloon. Once the balloon inside the stent is inflated, the stent expands, pushing against the artery wall, keeping the artery open, thereby improving blood flow. The mesh design allows cells to grow through and around it, securing it in place.
Tygon® is a brand name for a family of flexible polymer tubing consisting of a variety of materials to be used "across a range of specialized fluid transfer requirements". The specific composition of each type is a trade secret. Some variants have multiple layers of different materials. Tygon is a registered trademark of Saint-Gobain Corporation. It is an invented word, owned and used by Saint-Gobain and originated in the late 1930s. Tygon products are produced in three countries, but sold throughout the world. Tygon tubing is used in many markets, including food and beverage, chemical processing, industrial, laboratory, medical, pharmaceutical, and semiconductor processing. There are many formulations of clear, flexible, Tygon tubing. The chemical resistance and physical properties vary among the different formulations, but the tubing generally is intended to be "so resistant to chemical attack that it will handle practically any chemical", whether liquid, gas, or slurry. While largely non-reactive, Tygon has been reported to liberate carbon monoxide and is listed among carbon monoxide-releasing molecules.
In medicine, a port is a small medical appliance that is installed beneath the skin. A catheter connects the port to a vein. Under the skin, the port has a septum through which drugs can be injected and blood samples can be drawn many times, usually with less discomfort for the patient than a more typical "needle stick".
The polymer solution casting process utilizes a mandrel, or inner diameter mold, that is immersed in a tank of polymer solution or liquid plastic that has been specifically engineered for the process. Due to a combination of thermal and frictional properties, the polymer solution then forms a thin film around the mold. The mold is then extracted from the tank in a precisely controlled manner, followed by a curing or drying process. Once the first layer of thin film is appropriately solidified, secondary features can be added to the product such as braided or coiled wire, laser-cut hypotubes or engineered metal reinforcements to prevent kinking, or imaging targets specific to the intended medical application. Multiple casting steps can then be repeated to encapsulate the reinforcements, build up wall thickness, add additional lumens and optimize column strength. The part is then removed from the mold after it is cured or solidified.
Due to the many regulations in the industry, the design of medical devices presents significant challenges from both engineering and legal perspectives.
