Surgical device to insert graft between skull and dura

Unmet Need

About 16,000 patients per year are diagnosed with a mastoid space defect. This is a defect in the skull that leads to hearing loss caused by cerebrospinal fluid leaking into the mastoid space, a porous and hollow area of the skull. Mastoid defects can be treated with a graft that is inserted between the skull and the dura in a surgery known as the transmastoid approach. This procedure is considered faster than other approaches with a shorter healing time, ultimately making it less of a burden on the patient. However, this procedure is difficult to execute because of challenges related to maneuvering the graft in a small, delicate space and carefully separating the dura from the skull to insert the graft. There is a need for better tools to help improve the safety and efficiency of inserting subdural grafts for treating mastoid defects.

Technology

Duke inventors have developed an ergonomic tool that makes the insertion of a subdural graft through the mastoid space easier for surgeons. This is intended to be used for the transmastoid surgical approach to correct mastoid space defects in the skull. Specifically, this small, handheld tool easily navigates through the mastoid space and then uses a unique, an unfolding petal design, to gently separate the dura from the skull and insert a graft into the bone defect. This has been demonstrated through the development of a functional prototype, which has been tested on plastic models of the skull and dura that replicate the architecture and mechanical properties of each tissue type.

Other Applications

This technology could also be used for other delicate surgical procedures, such as cranioplasties, repairing dural defects that occur after brain surgery, or repairing rupture of the ear drum.

Advantages

• Simple-to-use, ergonomic design that can be used and adjusted without a power source
• Improves ease of difficult surgical procedure in delicate area
• Locking and unlocking mechanism increases precision and control of graft deployment