Treace Medical Receives Lapiplasty® Patent

Last June we reported on Treace Medical Concepts, Inc., a small Florida company founded in early 2014 with a proprietary bunion deformity treatment called Lapiplasty®.

On April 18, 2017, the company announced that the U.S. Patent and Trademark Office issued U.S. Patent No. 9,622,805 which broadly covers the methods of multi-planar bunion correction embodied by the Lapiplasty® Procedure. This, according to the company, represents the first to issue in an “aggressive” pipeline of more than 20 patent applications held by the company on its system and related concepts.

According to CEO John Treace, “Bunion surgical outcomes have historically been associated with high rates of recurrence and patient dissatisfaction. Studies indicate a significant contributor to deformity recurrence to be failure to correct frontal plane rotation of the metatarsal bone (the third plane of the deformity).”

Treace says the procedure was designed to realign and correct all three planes of the bunion deformity in a straightforward and reproducible manner, which he believes will demonstrate improved clinical outcomes over time. “This patent issuance represents an exciting milestone for our company as it embodies the key surgical steps required to perform the breakthrough Lapiplasty® Procedure involving our novel instrumentation and implants.”

The Patent

The patent describes, “Methods for temporarily fixing an orientation of a bone or bones. Methods of correcting a bunion deformity. Bone positioning devices. Methods of using a bone positioning device. Bone preparation guides. Methods or using a bone preparation guide.”

The development of Lapiplasty® began in mid-2014 when surgeon designers identified bunion surgery as a procedure that lacked reliability and was universally frustrating. It had an unacceptably high recurrence and complication rates associated with many of the popular osteotomy procedures.

The surgeons presented the idea of attacking bunion deformity by way of a “three plane” correctional procedure. Treace’s team developed an instrumentation and fixation system to make the procedure reproducibly successful in any foot and ankle surgeon’s hands.

For those who like to dig a little deeper into the details of the patent documents, here is how the embodiments of the invention are described:

Embodiments of the present invention include methods for temporarily fixing an orientation of a bone or bones. In the method of positioning a bone includes the steps of moving a bone from an anatomically misaligned position to an anatomically aligned position with respect to another bone and preparing an end of the bone and a facing end of another bone.

In some embodiments, at least one bone end is prepared after the bone is moved into the aligned position.

In some embodiments, the bone is anatomically aligned in more than one plane such that the bone both translates and rotates in response to a moving force.

One embodiment includes a method of correcting a bunion deformity. The method has the steps of moving a first metatarsal from an anatomically misaligned position with respect to a second metatarsal to an anatomically aligned position with respect to the second metatarsal by applying a force to the first metatarsal, the force moving the first metatarsal to correct an alignment in more than one plane. The method can also include preparing an end of the first metatarsal and preparing an opposing end of a medial cuneiform and the first metatarsal fusion.

Embodiments or the invention also include a bone positioning device and a bone preparation guide, and methods or using such guides.

As we previously reported, the founders of Treace Medical are the same people who coined the term “kyphoplasty” and include the former CEO and Chairman of the Board of Kyphon and its key executives who helped build Kyphon.

To watch a video of the Lapiplasty® procedure, click here.