Patent No. US11096797 (titled "Zero-Profile Expandable Intervertebral Spacer Devices For Distraction And Spinal Fusion And A Universal Tool For Their Placement And Expansion") was filed by Moskowitz Family Llc on Sep 30, 2019.
’797 is related to the field of spinal fusion , specifically to intervertebral spacers designed to restore disc height and promote bone growth between vertebrae. The background involves traditional spinal fusion techniques that often require supplemental fixation like pedicle screws or anterior plating, which can lead to complications such as nerve damage, blood loss, and adjacent segment disease. Existing non-expandable spacers require forceful distraction of the vertebral bodies and may not perfectly fit the disc space.
The underlying idea behind ’797 is to provide a zero-profile, expandable intervertebral spacer that can be inserted in a collapsed state and then expanded in situ to precisely match the patient's anatomy. This calibrated expansion allows for controlled distraction of the disc space, nerve root decompression, and promotion of spinal fusion, all while minimizing the need for supplemental fixation and reducing the risk of complications associated with traditional methods.
The claims of ’797 focus on an expandable intervertebral fusion device comprising first and second movable portions and an expansion mechanism configured to move the first movable portion with respect to the second movable portion, wherein the expansion mechanism comprises at least a rotation screw having a screw head and a threaded shaft, wherein the expandable intervertebral fusion device defines first and second tool engagement indentations on first and second sides of the expandable intervertebral fusion device.
In practice, the device is inserted into the prepared intervertebral space using a specialized tool that engages indentations on the sides of the spacer. Once in place, a rotation screw is turned, which actuates a linkage mechanism to separate the top and bottom portions of the spacer. This expansion provides calibrated distraction of the vertebral bodies. The device includes cavities for packing bone fusion material to promote bone growth between the vertebrae. Some embodiments also incorporate bi-directional fixating transvertebral screws for added stability.
The key differentiation from prior approaches lies in the combination of a zero-profile design, calibrated in-situ expansion, and the potential for stand-alone use without supplemental fixation. The various embodiments offer different expansion mechanisms, including scissor jacks, tapered threads, and worm drives, allowing surgeons to choose the most appropriate design for a given patient and surgical approach. This individualized approach aims to reduce morbidity and improve the effectiveness of intervertebral spacer placement compared to traditional methods.
In the mid-2000s when ’797 was filed, spinal fusion was typically supplemented with posterior pedicle screw placement and/or anterior (or lateral) plating. At a time when intervertebral spacers were manufactured with different heights, the vertebral bodies were forcefully distracted to allow placement of an imperfectly fitting spacer. These were most often supplemented with pedicle screw and/or or plate fixation.
The examiner approved the application because the prior art does not disclose or reasonably teach an expandable intervertebral fusion device that includes a linkage connector positioned within a space between movable portions, operably connected to a rotation screw, and operably connected to a linkage arm. The rotation of the screw forces the linkage connector to move and pivot the linkage arm, pushing the movable portion to expand the device. The examiner also stated that the prior art does not teach a specific tool with engagement prongs, a second tool with a passage, and a third adjusting tool with a screw engagement portion and shaft.
This patent contains 20 claims, with claims 1 and 16 being independent. Independent claim 1 focuses on an expandable intervertebral fusion device with a specific expansion mechanism, while independent claim 16 focuses on a system including the fusion device and specialized tools for insertion and adjustment. The dependent claims generally elaborate on and refine the features and components described in the independent claims, adding details to the device, system, and their operation.
Definitions of key terms used in the patent claims.

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