Originally Published MPMN November 2006

Susan Shepard

Components that are commonly used to fire sporting guns or inflate flotation devices and air bags are now being used in medical equipment. Single-use gas cylinders can be used for critical functions such as inflation, pressurization, propulsion, cooling, and particle acceleration, or as a form of mechanical energy. The disposable cylinders from iSi Components (Fairfield, NJ; www.isicomponents.com) range in size from 10 to 700 ml. Inert gases include carbon dioxide, nitrogen, nitrous oxide, and argon.

The gas cylinders have been incorporated into some medical products that have recently been approved. One of them is a balloon angioplasty device for the treatment of peripheral vascular disease. Similar to a conventional angioplasty device, it uses a liquid nitrous oxide to inflate the balloon instead of the traditional saline. The gas also cools the vessel during dilation, which may be gentler to the patient than traditional angioplasty, and may have associated clinical benefits, according to the company.

Another example is a minimally invasive, handheld breast biopsy device that is an alternative to spring-loaded units. The gas from the cylinder propels and retracts the biopsy needle with a high degree of precision and reliability, and reportedly allows the tissue to adhere to the core biopsy samples in volumes larger than those retrieved by the more traditional methods.

The company is ISO 9001:2000 certified and its quality management program includes 100% safety testing, 100% accelerated leakproof testing, computerized QA records and controls, weight checks and controls throughout the manufacturing process, and independent audits and certification. UPS 28 gas quality certificates are available on request.

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