Patent No. US10874446 (titled "Bone positioning guide") on Dec 31, 2019. The application was issued on Dec 29, 2020.
’446 is related to the field of orthopedic surgical instruments and, more specifically, to devices used for the anatomical realignment of bones. In procedures such as bunion corrections or Lapidus fusions, surgeons must often manually manipulate small bones of the foot into a corrected position across multiple planes. The background context involves the difficulty of maintaining this precise alignment while simultaneously preparing joint surfaces and applying permanent fixation, which can lead to inconsistent clinical outcomes.
The underlying idea behind ’446 is a mechanical framework that provides controlled, multi-planar realignment by applying compressive force between two different metatarsals. By utilizing a rigid body that spans the space between the first metatarsal and a lateral metatarsal, the device allows a surgeon to translate and rotate the first metatarsal into a natural anatomical position. This approach moves away from manual manipulation, using a mechanical advantage to hold the bones steady while the surgeon performs bone preparation and fixation.
The claims of ’446 focus on a bone positioning guide specifically adapted for bunion correction, featuring a main body member that supports a bone engagement member and a tip on opposing sides. A critical element of the claimed design is a depth stop integrated with the tip, which is engineered to regulate how far the instrument penetrates relative to the lateral metatarsal. The assembly includes a mechanism that enables the bone engagement member and the tip to be moved toward one another to exert the necessary corrective force.
In practical implementation, the device functions by placing the tip against the lateral side of a second or third metatarsal while the bone engagement member contacts the medial side of the first metatarsal. As the mechanism is actuated—often via a threaded shaft or similar actuator—the distance between the two contact points decreases. This action reduces the intermetatarsal angle and can simultaneously induce axial rotation in the frontal plane, effectively supinating the first metatarsal back into its proper orientation.
This invention differs from prior approaches by providing a stable, hands-free method of maintaining a three-dimensional correction throughout the surgical workflow. Unlike traditional clamps that might slip or lack precision, the inclusion of a depth stop ensures consistent placement against the anchoring bone, while the rotatable coupling of the engagement member allows it to adapt to the bone's surface without causing unwanted trauma. This allows for precise bone preparation through a guide while the positioning instrument remains securely in place.
In the mid-2010s when ’446 was filed, surgical bone realignment was typically implemented using manual manipulation where a clinician would physically reposition bone segments and attempt to maintain that alignment while simultaneously applying fixation hardware. At a time when systems commonly relied on static clamps or manual force rather than integrated mechanical guides for multi-planar correction, achieving consistent anatomical results was difficult due to the instability of the bones during the transition from alignment to fixation. Hardware and software constraints in surgical planning made the precise, repeatable correction of complex deformities non-trivial, as standard instrumentation often lacked the structural rigidity and fine-tuned control necessary to hold small bones in a specific three-dimensional orientation without obstructing the surgical site.
The disclosed invention represents a technical advancement in orthopedic instrumentation through the integration of a wrap-around main body architecture that defines a dedicated realignment space between a movable bone engagement member and a fixed tip. This structural solution enables an architectural shift from manual bone holding to a controlled mechanical translation, where a threaded shaft provides incremental, stable movement of a first bone relative to a second bone. The technical effect achieved is the ability to maintain a precise realignment across the frontal, transverse, and sagittal planes simultaneously while leaving the joint area accessible for fixation. This overcomes the technical constraint of maintaining multi-planar anatomical correction during the application of permanent fixation hardware, ensuring that the achieved alignment does not shift during the final stages of a surgical procedure.
This patent contains 30 claims, with claim 1 being the only independent claim. The independent claim focuses on a bone positioning guide for bunion correction that includes a main body, a bone engagement member for the first metatarsal, a tip for a different metatarsal, a depth stop to control tip insertion, and a mechanism to move the engagement member and tip closer together. The dependent claims serve to specify anatomical placements, define various surface geometries and curvatures of the engagement member and tip, detail specific mechanical components such as ratchets or actuators, and describe material properties and construction methods for the device.
Definitions of key terms used in the patent claims.
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