Patent No. US11950819 (titled "Bone positioning guide") on Mar 13, 2023. The application was issued on Apr 9, 2024.
’819 is related to the field of orthopedic surgery and mechanical bone realignment, specifically addressing the correction of anatomical deformities in the foot. The background context involves the difficulty surgeons face when manually attempting to realign bones, such as the first metatarsal during a bunion correction, while simultaneously trying to maintain that alignment for permanent fixation. Traditional methods often result in inconsistent outcomes because the surgeon must manage complex three-dimensional movements across multiple planes without stable mechanical assistance.
The underlying idea behind ’819 is the use of a mechanical guide that applies controlled, opposing forces between two different bones to achieve a multi-planar correction. By anchoring a tip on a stable reference bone and advancing a bone engagement member against the misaligned bone, the device translates the inventor's insight that a single mechanical action can simultaneously reduce the intermetatarsal angle and correct axial rotation in the frontal plane. This approach replaces manual manipulation with a stable, screw-driven or ratcheted mechanism that holds the bones in a precise, corrected orientation during the preparation and fixation phases.
The claims of ’819 focus on a comprehensive bone positioning system that integrates a positioning guide, a tissue removing instrument, and a fixation device. The independent claims specifically cover a guide operable to move a metatarsal in at least one plane—and specifically multiple planes including the frontal plane—to correct its alignment relative to an opposed cuneiform. The system is designed to facilitate the entire fusion workflow, from the initial mechanical realignment to the preparation of the bone ends and the final application of a fixation device across the tarsometatarsal joint.
In practice, the system works by placing the guide's tip against a stable lateral metatarsal while the concave bone engagement member grips the medial ridge of the first metatarsal. As the clinician actuates the shaft, the first metatarsal is urged toward the second, naturally rotating the bone into a proper anatomical position. Once the desired alignment is achieved, a bone preparation guide is often used to ensure that the cuts made to the metatarsal and cuneiform are perfectly parallel and conforming, which is critical for a successful fusion and long-term stability.
This invention differs from prior approaches by providing a rigid framework that maintains the corrected position hands-free, allowing the surgeon to focus on precise bone resection and hardware placement. Unlike traditional clamps that only provide compression, this system utilizes a fulcrum effect and multi-planar control to address the rotational component of bunion deformities, which is frequently overlooked in standard procedures. By combining the realignment tool with specialized cutting guides, the system ensures that the final orientation of the bones matches the intended surgical plan without the risk of the bones shifting during the procedure.
In the mid-2010s when ’819 was filed, orthopedic surgical procedures for bone realignment were typically implemented using manual manipulation and handheld instrumentation to adjust the relative position of adjacent bones. At a time when surgeons commonly relied on freehand techniques to maintain anatomical reduction while simultaneously applying fixation hardware, the physical coordination required to hold bones in a corrected multi-planar orientation was significant. Hardware constraints made the precise, stable maintenance of bone position non-trivial, as standard clamping tools often lacked the specific geometry or mechanical control necessary to secure small bones, such as metatarsals, in a fixed relationship without obstructing the surgical site or losing alignment during the transition to permanent fixation.
The disclosed invention represents a meaningful technical advancement through the integration of a specialized C-shaped main body with a movable threaded shaft and a rotatable bone engagement member. This architectural shift enables a controlled mechanical reduction of bone misalignment by translating linear shaft movement into precise anatomical positioning between a first and second bone. The structural configuration overcomes the technical constraint of manual instability by providing a stable, hands-free bone realignment space that allows a clinician to achieve and hold multi-planar correction—specifically across the frontal, transverse, and sagittal planes—while simultaneously performing fixation. This capability ensures consistent treatment results by maintaining the desired alignment during the application of pins, screws, or plates, which was previously difficult to achieve with traditional manual methods.
The patent contains a total of 20 claims, with claims 1 and 13 serving as the independent claims. These independent claims focus on a bone positioning system designed for bunion correction and tarsometatarsal joint fusion, specifically featuring a guide for moving a metatarsal in one or more planes, a tissue removing instrument for joint preparation, and a fixation device for stabilizing the bones. The dependent claims serve to provide additional specificity regarding the mechanical components of the positioning guide, the specific types of tissue removing instruments and fixation hardware used, and the inclusion of temporary fixation tools like wires to hold the bone position prior to permanent fusion.
Definitions of key terms used in the patent claims.
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