Riverview-surgeon-invents-new-spinal-device-AL-700420-03-TransparentWhite-1An orthopedic surgeon at Riverview Regional Medical Center in Gadsden has invented a new medical device that makes spinal fusions easier and customizable for each individual patient.

Dr. Dusty Smith’s Sagittae device was cleared by the FDA last year and has since been used on at least three patients in Gadsden.

The Sagittae is a lateral lumbar interbody fusion device — or, in simpler terms, a device used to support vertebrae in the spine when the discs between them have become degenerative.

The small metal device uses a unique design to allow it to be adjusted after it is placed in between the vertebrae, either by tilting or changing the height.

“Nothing else is dynamic like this,” Smith said.

The gadget almost resembles a miniaturized animal trap, with toothed edges and a pair of screws on the end. The teeth, however, are only there to provide tracks for the screws to fit into as they are adjusted to change the height and angle of the piece.

Once the Sagittae is inserted into the spine, the surgeon can adjust it to perfectly fit each patient’s bones. Before, fusions were done with rigid, plastic wedges that could not be easily adjusted once they were inserted.

“This gives us a lot of flexibility,” said Skylar Deerman, a medical device distributor who has worked on the Sagittae with Smith.

Smith said he was inspired to develop a new device after seeing how those previous fusion devices could be improved. They typically come in different sizes, but even that limited any sort of customization to fit the individual’s body.

“That wedge has always been a static block,” he said. “A lot of surgeons have wanted something where we can expand the space in between the bones and tilt the spine to get it in better alignment. That technology just hasn’t existed.”

That changed when Smith began working with a group of engineering students from the University of Missouri Kansas City to design the Sagittae. Smith was working in Missouri at the time and heard that a senior engineering class at the university was holding a contest allowing people with invention ideas to pitch their projects to the class.

They voted on which ones to pursue, and Smith’s device received the most support. He was able to work with the top students in the class to develop the Sagittae.

That process took time, especially since the device was not the only part needing to be engineered. A tool that could adjust the device needed to be engineered as well.

The special tool looks like a bulked-up screwdriver with two shanks, but a chamber near the handle controls fine-tuned amounts of torque and a combination of settings that control different adjustments in the device.

Smith and Deerman said engineers are trying to redesign the tool to be more compact, but in order to preserve the torque needed to adjust the Sagittae, it will have to remain bigger than a typical screwdriver.

Once the device is in place and adjusted, a hollow section in the center can be filled with bone grafts that will help the vertebrae around it fuse to the device. Implanting it can also take a much shorter time than previous devices, sometimes cutting procedure time in half.

The procedure also has a shorter recovery time, as the device is implanted through an incision in the side, which causes less interference with back muscles. Smith said some patients are able to get up and walk on the day of the surgery, too.

One of the biggest benefits the Sagittae provides, however, is a relief in the curve of the spine that can occur when discs degenerate. That curvature leads to more disc degeneration and can lead to needing more fusions.

“This puts the spine in a healthier position to prevent further deterioration,” Smith said.

The device received 510(k) clearance by the Food and Drug Administration in October 2018, but Smith said he needed to use the Sagittae a few times before was widely marketed and used in other hospitals.

As of this month, he had inserted four of the devices during three surgeries, as one patient needed two implants.

A press release from SpineEx, the medical device company that manufactures the Sagittae, said the device could be used for patients with Degenerative Disc Disease affecting discs from levels L2 to S1 in the spine. Smith said that it also could be used to treat scoliosis, sciatica, and other spine issues.

The only candidates who would not be able to use the device, he said, would be those whose bones are too brittle to graft onto the device or patients who are too obese for the procedure. X-rays are used during the procedure to check the alignment and placement of the device, and it is less visible through X-rays in larger bodies.

Still, the small footprint of the device and complete adjustability of it would allow it to be used in patients of any age and Smith said most patients needing a fusion would be able to use the device.

For now, the Sagittae is only being used at Riverview. Before long, though, it could be distributed and put to use in hospitals around the U.S. and beyond.

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