After an incision has been performed in a surgical procedure, retractors are used to hold
the wound open while surgeons operate. There are several different retractors
currently used during small-incision procedures.

Each of these designs falls short of a complete solution for the surgeon’s needs for a
variety of reasons. Hand-held retractors require assistance from a surgical assistant, which often
overcrowds the surgical area and obstructs the surgeon’s field of view. Self-
retaining devices retract only in one plane, are bulky, do not interact with additional instruments
used during surgical procedures, and do not indicate the magnitude of pressure being exerted on
the patient’s tissue.

Our product is aimed at reducing the risk factors associated with these shortcomings.
These include: scarring, nerve damage, necrosis, and, in the case of orbital surgery, blindness
through accidental optic nerve manipulation.

Our proposed self-retaining retractor is categorized by the FDA as a manual surgical
instrument for general use. 3 This classifies it as class one device, with regulation number
878.4800. It will be used in small incision surgeries for aesthetic and functional purposes. This includes surgeries requiring an incision less than or equal to 5
centimeters. An important aspect of any surgical device is its ability to interact with other
essential equipment. In our case, this includes: electrocautery, suction machines, and sterilization
equipment (steam, gas, and dry heat). The operation and maintenance of our
retractor follow commonly used procedures.

This product will benefit surgeons in many different specializations that perform small
incision surgeries by improving surgical conditions, reducing the underutilization of personnel,
and providing extra measurements for patient’s safety.