Patent No. US9936994 (titled "Bone positioning guide") on Jul 14, 2016. The application was issued on Apr 10, 2018.
’994 is related to the field of orthopedic surgery and surgical instrumentation, specifically focusing on devices used for the anatomical realignment of bones. In procedures such as bunion corrections or metatarsal fusions, surgeons must often manipulate small bones in multiple dimensions simultaneously to achieve proper alignment before permanent fixation. Traditional manual methods can be inconsistent, as holding a bone in a corrected position while preparing joint surfaces or applying hardware is technically demanding.
The underlying idea behind ’994 is a mechanical framework that converts a simple linear or clamping force into a multi-planar corrective movement. By anchoring a guide against a stable reference bone and applying a controlled force to a misaligned bone, the device forces the target bone to not only translate laterally but also to rotate axially. This insight recognizes that deformities like hallux valgus are three-dimensional, requiring a frontal plane rotation (supination/pronation) alongside transverse plane shifting to restore natural anatomy.
The claims of ’994 focus on a bone positioning guide comprising a bone engagement member, a tip, and an actuation mechanism designed to urge these two components toward one another. The independent claim specifically protects a device where this closing action is configured to move a first bone in more than one plane relative to a second bone. Crucially, this movement must include correction about an axis in the frontal plane, ensuring the device addresses the rotational component of the bone deformity.
In practical application, the guide utilizes a C-shaped main body where a threaded shaft advances a concave engagement member toward a stationary tip. The tip is typically placed percutaneously against the lateral side of a stable metatarsal, while the engagement member grips the medial ridge of the first metatarsal. As the surgeon turns the actuator, the geometry of the device and the resistance of the anatomy work together to reduce the intermetatarsal angle while simultaneously rotating the bone back into its proper orientation.
This approach differentiates itself from prior solutions by providing a stable, hands-free hold on the corrected alignment throughout the surgical workflow. Unlike standard clamps that only provide compression, this invention acts as a temporary jig that maintains the three-dimensional correction. This allows the surgeon to accurately place bone preparation guides and fixation hardware without the risk of the bone slipping back into a deformed state during the procedure.
In the mid-2010s when ’994 was filed, surgical bone realignment was typically implemented using manual manipulation where a clinician physically held bones in a corrected orientation while simultaneously attempting to apply 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 precise anatomical alignment was often inconsistent. Hardware and software constraints in surgical planning made the simultaneous stabilization and three-dimensional adjustment of small bones, such as metatarsals, non-trivial, as existing instruments often lacked the mechanical leverage or structural geometry to maintain a specific realignment space while leaving the surgical site accessible for permanent fixation.
The disclosed invention represents a meaningful technical advancement through the integration of a specialized C-shaped or wrap-around main body architecture that defines a dedicated bone realignment space between a movable bone engagement member and a fixed tip. This structural solution overcomes the technical constraint of manual instability by utilizing a threaded shaft to provide controlled, incremental translation of one bone relative to another, enabling precise realignment across the frontal, transverse, and sagittal planes. The technical effect achieved is the ability to mechanically hold a complex anatomical correction in a stable state, allowing a clinician to perform fixation procedures—such as pinning or plating—without the risk of bone migration during the transition from alignment to permanent stabilization.
The patent contains a total of 16 claims, with claim 1 being the sole independent claim. This independent claim focuses on a bone positioning guide featuring a bone engagement member, a tip, and an actuation mechanism designed to move and align a first bone relative to a second bone across multiple planes, specifically including rotation about an axis in the frontal plane. The remaining 15 dependent claims serve to further define the device by specifying structural components such as threaded shafts and knobs, detailing the geometric shapes and surface textures of the tip and engagement member, and identifying specific anatomical applications and material properties.
Definitions of key terms used in the patent claims.
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