Minneapolis, Minnesota — Minnesota Rubber and Plastics (MR&P) provides medical device manufacturers with seal designs molded of rubber and plastics to meet a wide range of sealing requirements. Among these are complex check valve seals used in topical oxygen therapy products designed to promote wound healing.
The topical oxygen therapy is used to treat patients with non-healing wounds such as burns, diabetic ulcers, pressure sores and post-op wounds. The FDA approved topical oxygen device, marketed by GWR Medical, Inc. of Chadds Ford, PA, is designed to provide an oxygen enriched environment around the wound area for extended periods allowing the wound to heal. The device is designed in two versions, a boot and sacral model. The boot model fits around areas of the leg and arms while the sacral model fits around the body itself. When positioned properly, the device provides an airtight cavity of oxygen surrounding the wound.
The check valve/relief valve assembly used in both models of this device is extremely important to ensure proper function. Both the check valve and relief valve functions are controlled by the double silicone diaphragm in the middle of the assembly and the 2 mating outer components (polycarbonate), which hold and center the diaphragm. The check valve stops the flow of oxygen out of the bag if the patient disconnects from the oxygen source. The relief valve maintains the inflation pressure inside the bag so that the bag is inflated and maintains its optimal pressure setting. Combining these two functions into a single double diaphragm reduced the part count, eliminated separate springs and seals, and simplified assembly.
The three-piece assembly also creates a seal between the bag and check valve/relief valve assembly when snapped together thereby eliminating the need for adhesive or welding operations.
Minnesota Rubber and Plastics provided product design and materials engineering in the development and manufacture of this check valve/relief valve assembly. The company operates an ISO 13485:2003 certified quality management system and manufactures these and a full range of medical sealing devices in Class 10,000 and Class 100,000 clean rooms.
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