1. Inter-Operative BIOmechanical Surgical Splint By: Nick Schlewitz Department of Biomedical Engineering Vanderbilt University Advisors: Dr. Paul King, Vanderbilt University; Dr. Edward Glaser, D.P.M BIOSS

2. What’s a Bunion? A bunion is calcium deposit which occurs at the head of the first metatarsal. The extra calcium causes a separation of the first and second metatarsals. The big toe commonly crosses over the second toe if left untreated. The greater the separation, the more severe the operation to correct it.

3. Fix My Bunion There are more than 171,000 bunion surgeries performed each year, and nearly 20,000 of those are so severe they require restructuring of the first metatarsal. This is called a closing wedge osteotomy. Closing wedge osteotomies are major operations and carry severe complications, sometimes crippling the patient. Radiograph of a patient’s first metatarsal following a closing wedge osteotomy. A pin has been inserted to align the first metatarsal in the correct position.

4. Complications? The most common complication resulting from a closing wedge osteotomy is called Metatarsus Primus Elevatus (MPE). MPE is best described as an elevation of the big toe. The toe becomes fixated in this position and becomes rigid or completely immobile. This condition can be crippling and/or lead to future operations. MPE, the big toe is clearly raised as a result of a closing wedge osteotomy

5. Why MPE? How do we treat it? MPE is caused by one of two reasons: 1.Surgical technique, which involves the precision of the cut in the bone. 2.Post-operative weight bearing Both causes can be addressed during the healing stages, when the foot is bandaged, with a splint that holds the toe in the correct position and sustains its mobility. This is precisely what BIOSS is designed to do.

6. BIOSS: How it Works BIOSS is designed to alleviate MPE by two mechanisms: 1.By providing arch support, the plantar fascia tendon will act to pull the big toe down, eliminating elevatus. This mechanism is called the windlass effect. 2.By incorporating a continuous passive motion device (CPM), the big toe will be well nourished, causing it will heal faster, and it will not stick to the healing bone.

7. The Design The arrow indicates the arch support which is unique to each persons foot. The entire foot bed and toe guard are made of a low density polyethylene plastic and connected with a locking nut and bolt. BIOSS prototype showing the arch support

8. Continuous Passive Motion In order to continuously move the toe, a 3 RPM geared motor was attached as shown. By moving the big toe, healing time is reduced and patient satisfaction following the procedure is increased. BIOSS prototype emphasizing the CPM feature

9. Manufacturing The conditions necessary for production required that the materials be currently available at Sole Supports. The plaster used by Sole Supports created the foot mold and modifications were made to allow for in- plant plastic pressing. The plastic used was a low density polyethylene for its strength and cost advantages.

10. Testing In order to sell the product, the effectiveness of BIOSS must be tested. Dr. Bud Hawthorn has agreed to use a completed device on his patients following closing wedge osteotomies. If successful, other local podiatrists will be encouraged to participate and their results will be documented and acted upon.

11. Marketing Using the Sole Supports podiatric clientele, it will be easy to inform and appeal to the podiatric market that BIOSS is designed to attract. Dr. Glaser is a professional speaker who has spoken at the American Podiatric Medical Association and has the ability to bring BIOSS to life.