The U.S. Patent and Trademark Office has granted two U.S. patents for a family of truly novel spinal interbody fusion devices which were, in part, designed using access surgeon input.
The U.S. Patent Numbers 11,471,298 and 11,471,299.
As the images illustrate, these are truly one-of-a-kind interbody cage implants.
According to the patent abstract, each implant is “for use in a plurality of surgical approaches includes a cage, a top end, a bottom end, and at least a first side representing the width of the cage and at least a second side representing a length of the cage.”
Additionally, “the cage includes fixation holes and inserter holes, with each fixation hole being configured for accepting a screw or anchor and each inserter hole being accessible for one or more surgical approaches [emphasis added] for performing a spinal fusion. Also included are methods for selecting a size of an intervertebral implant and methods of surgically approaching a spine of a patient for spinal surgical procedures.”
The patent assignee is NovApproach Spine, LLC, an Alachua, Florida-based medical equipment company focused on advanced surgical approaches and implants for spinal surgeries.
The inventors for the ’298 patent include the following: NovApproach Spine Founder and CEO Raymond Cloutier; University of California San Francisco Professor and Chief of Spine Service Sigurd Berven, M.D.; NovApproach Spine Senior Consultant Michael Macmillan; and Vascular Associates of San Diego Vascular Surgeon Thomas Terramani, M.D., FACS.
The inventors for the ’299 patent include the following: Cloutier; Macmillan; Dr. Terramani; and Elezar Tonev.
According to NovApproach, the two patents are for the company’s “multi-hole/multi-insertion invention employed in our OneLIF™ spinal interbody fusion cage.” The patent gives NovApproach Spine “the exclusive right to the only cage that can be placed from any anterior or oblique spinal approach—each with a stand-alone screw fixation option.”
NovApproach Spine Founder and CEO Raymond Cloutier told OTW, “The OneLIF™ cage is the only interbody that provides multiple (six) fixation positions and two insertion trajectories. These enable ‘game time’ decision-making for all cases—especially important when confronted with ‘hostile’ anatomy, such as: prior surgical scarring, mesh implants, and difficult-to-mobilize critical blood vessels that limit spinal exposure.”
“It can be delivered through both anterior and oblique corridors and implanted with standalone market clearance. Our unique IP [intellectual property] provides spine surgeons greater flexibility to make intraoperative decisions which can reduce surgical time and risk. To my knowledge, no other cage provides this degree of versatility.”
Dr. Berven told OTW, “The OneLIF device permits an approach to the interbody space that is responsive to vascular and neural structures and facilitates the safest pathway for interbody reconstruction.”
Dr. Terramani told OTW, “The device will provide flexibility in the operating room and allow the ability to treat many variables that present themselves during surgery on the spine. It helps surgeons manage upper spine segments and adjacent segment disease, as well as dealing with hostile abdomens and severe vascular disease. The OneLIF cage has the flexibility to be deployed in both the direct anterior as well as the oblique pathway to the spine. It is a major advantage to the patient to have this flexibility and safety when addressing their spine disease.”
