Bone positioning guide

Patent No. US11185359 (titled "Bone positioning guide") on May 24, 2019. The application was issued on Nov 30, 2021.

What is this patent about?

’359 is related to the field of orthopedic surgery and mechanical bone realignment. Specifically, it addresses the technical challenges of correcting complex, multi-planar deformities in the foot, such as bunions (hallux valgus), where a metatarsal must be precisely repositioned and stabilized relative to adjacent bones to ensure successful long-term fusion.

The underlying idea behind ’359 is that a single-point mechanical compression force, applied between the medial side of a misaligned first metatarsal and the lateral side of a stable neighboring metatarsal, can simultaneously correct deformities in the transverse, sagittal, and frontal planes. By utilizing a C-shaped main body to bridge the foot's anatomy, the device allows a surgeon to translate and rotate the bone into an anatomically correct orientation using a controlled mechanical actuator rather than manual manipulation.

The claims of ’359 focus on a method for correcting the position of a first metatarsal using a specialized positioning guide. The process involves placing a bone engagement member on the medial side of the first metatarsal and inserting a tapered tip through a percutaneous incision into the intermetatarsal space between the second and third metatarsals. By reducing the distance between these two points, the guide forces the first metatarsal to move in the transverse plane, effectively reducing the intermetatarsal angle before permanent fixation is applied.

In practice, the invention functions as a temporary external jig that maintains the corrected bone orientation while the surgeon prepares the joint surfaces. A cannulated shaft allows for the insertion of a K-wire to provisionally lock the bone's position, while a separate bone preparation guide can be indexed to the joint to ensure that bone cuts are perfectly parallel. This systematic approach ensures that the final fusion surfaces are optimized for contact and stability, reducing the risk of the deformity recurring.

This method differs from prior approaches by moving away from manual, freehand realignment which often fails to address the axial rotation of the metatarsal in the frontal plane. Unlike traditional clamps that may only compress bones together, this system uses the second and third metatarsals as a stable mechanical anchor. By incorporating a fulcrum at the base of the metatarsals, the device prevents unwanted lateral shifting (base shift) during the correction, ensuring the bone pivots precisely into its natural anatomical position.

How does this patent fit in bigger picture?

Technical Landscape

In the mid-2010s when ’359 was filed, orthopedic surgical procedures for bone realignment were typically implemented using manual manipulation and handheld instrumentation to achieve anatomical correction. At a time when systems commonly relied on the surgeon’s tactile force and visual estimation to maintain bone orientation during fixation, the process of stabilizing small bones in multiple planes was often non-trivial due to the mechanical difficulty of simultaneously applying compression and rotational correction. Hardware constraints in existing surgical clamps often limited their use to simple compression or distraction, making the precise, repeatable realignment of adjacent bones—such as metatarsals in a bunion correction—highly dependent on manual dexterity rather than integrated mechanical guidance.

Prosecution Position

The disclosed invention represents a meaningful technical advancement through the integration of a specialized bone positioning guide that enables multi-planar realignment of bones via a controlled mechanical interface. The architectural solution involves a main body with a wrap-around geometry that defines a bone realignment space between a movable bone engagement member and a fixed tip. This structure enables a technical shift from manual bone holding to a mechanical system where a threaded shaft provides precise, incremental translation of one bone relative to another. The technical effect achieved is the ability to hold a bone in a corrected position across the frontal, transverse, and sagittal planes simultaneously, overcoming the constraint of maintaining complex anatomical alignment while the clinician performs permanent fixation.

Claims

The patent contains 19 claims in total, with claim 1 serving as the sole independent claim. This independent claim focuses on a surgical method for correcting the position of a first metatarsal by utilizing a bone positioning guide that spans from the medial side of the first metatarsal to the intermetatarsal space between the second and third metatarsals to reduce the intermetatarsal angle. The dependent claims serve to further define specific procedural parameters such as target angle ranges, additional bone preparation and compression steps, multi-planar adjustments, and the specific mechanical features or fixation hardware used during the orthopedic procedure.

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 clinician may translate the shaft relative to the main body until the bone engagement member contacts a medial side of a first metatarsal. 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.A component located on the distal end of a shaft designed to contact and apply force to a specific bone surface to facilitate realignment.
Bone fixation device
(Claim 1)
The clinician may fixate the position of the realigned first metatarsal while the bone positioning guide holds the first metatarsal in the realigned position. For example, the clinician may use pins, screws, plates, wire and/or other desired fixation instruments to secure the first metatarsal to a medial cuneiform. These instruments serve as the bone fixation device to maintain the corrected position.Mechanical hardware used to permanently or temporarily secure bones in a corrected anatomical position after realignment.
Intermetatarsal angle
(Claim 1)
A procedure utilizing an embodiment of the bone positioning guide can be performed to correct an alignment between a metatarsal (e.g., a first metatarsal) and a second metatarsal. As the bone engagement member is advanced toward the tip, the position of the first metatarsal may be realigned and corrected. This correction reduces the angle between the bones in at least a transverse plane.The angular relationship between the longitudinal axes of two metatarsal bones, which is reduced during the realignment procedure.
Intermetatarsal space
(Claim 1)
The method includes making an incision to access an intermetatarsal space between a second metatarsal and a third metatarsal. The clinician may position the tip in contact with the lateral side of a second metatarsal. The tip is positioned through the incision and into the intermetatarsal space to provide a counter-pressure point for realignment.The anatomical gap or area located between two adjacent metatarsal bones, specifically used here as a placement site for the guide's tip.
Transverse plane
(Claim 1)
The position of the first metatarsal may be realigned in three planes, including a frontal plane, a transverse plane, and a sagittal plane. The guide causes the first metatarsal to move in at least a transverse plane to reduce an intermetatarsal angle. This realignment corrects the anatomical misalignment of the bones.One of the three anatomical planes of motion in which the bone is realigned, specifically relating to the side-to-side or horizontal movement of the metatarsal.

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

Patent Family

Patent Family

File Wrapper

The dossier documents provide a comprehensive record of the patent's prosecution history - including filings, correspondence, and decisions made by patent offices - and are crucial for understanding the patent's legal journey and any challenges it may have faced during examination.

  • Get instant alerts for new documents

US11185359

Application Number
US16422557A
Filing Date
May 24, 2019
Publication Date
Nov 30, 2021
External Links
Slate, USPTO , Google Patents