Bone positioning guide

Patent No. US10874446 (titled "Bone positioning guide") on Dec 31, 2019. The application was issued on Dec 29, 2020.

What is this patent about?

’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.

How does this patent fit in bigger picture?

Technical Landscape

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.

Prosecution Position

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.

Claims

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.

Key Claim Terms New

Definitions of key terms used in the patent claims.

Term (Source)Support for SpecificationInterpretation
Bone engagement member
(Claim 1)
The shaft can carry a bone engagement member on a distal end of the shaft configured to engage with a bone. The bone engagement member is rotatably coupled to the shaft and has a surface configured to engage a bone. In use, the clinician can position the bone engagement member in contact with a medial side of a first metatarsal.A component situated on one side of the main body member designed to interface directly with the first metatarsal to facilitate its movement.
Depth stop
(Claim 1)
The bone positioning guide includes a depth stop configured to limit a depth of insertion of the tip relative to the metatarsal other than the first metatarsal.A physical constraint or feature associated with the tip that prevents it from being inserted beyond a specific distance relative to the targeted bone.
Mechanism
(Claim 1)
The first terminal end of main body can have a threaded shaft aperture through which a threaded shaft extends. The clinician may continue translating the shaft relative to the main body, causing the bone engagement member to advance toward the tip. As the bone engagement member is advanced toward the tip, the position of the first metatarsal may be realigned and corrected with respect to the second metatarsal.The mechanical assembly, such as a threaded shaft or translating component, that enables controlled relative motion between the bone engagement member and the tip to adjust bone alignment.
Tip
(Claim 1)
The second terminal end of the main body can have a tip also configured to engage with bone. The clinician may position the tip in contact with the lateral side of a second metatarsal. The clinician may continue translating the shaft relative to the main body, causing the bone engagement member to advance toward the tip.A structural feature located on the opposite side of the main body from the bone engagement member, serving as a contact point or anchor against a second bone.

Litigation Cases New

US Latest litigation cases involving this patent.

Case NumberFiling DateTitle
2:24-cv-09763Oct 14, 2024TREACE MEDICAL CONCEPTS, INC. v. STRYKER CORPORATION et al

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US10874446

Application Number
US16731612A
Filing Date
Dec 31, 2019
Publication Date
Dec 29, 2020
External Links
Slate, USPTO , Google Patents