Bone positioning guide

Patent No. US11950819 (titled "Bone positioning guide") on Mar 13, 2023. The application was issued on Apr 9, 2024.

What is this patent about?

’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.

How does this patent fit in bigger picture?

Technical Landscape

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.

Prosecution Position

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.

Claims

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.

Key Claim Terms New

Definitions of key terms used in the patent claims.

Term (Source)Support for SpecificationInterpretation
Bone positioning guide
(Claim 1, Claim 13)
In some examples, a bone positioning guide includes a main body that has a first terminal end and a second terminal end. The first terminal end of main body can have a threaded shaft aperture through which a threaded shaft extends, carrying a bone engagement member on a distal end. The second terminal end of the main body can have a tip also configured to engage with bone.A mechanical instrument comprising a main body with a first and second terminal end, a movable shaft, and a bone engagement member, designed to apply force to realign a bone (such as a metatarsal) relative to another bone or joint.
Fixation device
(Claim 1, Claim 13)
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 in the realigned position while the bone positioning guide holds the first metatarsal in the realigned position.Hardware used to secure and maintain the corrected alignment of bones during the healing and fusion process.
Frontal plane
(Claim 13)
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. For example, the position of the first metatarsal may be realigned in three planes, including a frontal plane, a transverse plane, and a sagittal plane.One of the three anatomical planes of motion in which the bone positioning guide can realign a bone, specifically relating to rotational or side-to-side correction.
Tarsometatarsal joint
(Claim 1, Claim 13)
An example of such a procedure is a Lapidus procedure (also known as a first tarsal-metatarsal fusion). In one example, 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 and/or a cuneiform (e.g., a medial, or first, cuneiform).The joint between the cuneiform bones and the metatarsal bones where the realignment and fusion procedure is performed.
Tissue removing instrument
(Claim 1, Claim 13)
Embodiments of the bone positioning guide can be useful during a surgical procedure, such as a bone alignment, osteotomy, fusion procedure, and/or other procedures where one or more bones are to be prepared (e.g., cartilage or bone removal and/or cut). An example of such a procedure is a Lapidus procedure (also known as a first tarsal-metatarsal fusion).A surgical tool used to prepare bone surfaces for fusion by removing cartilage or bone material at the joint interface.

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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US11950819

Application Number
US18182995A
Filing Date
Mar 13, 2023
Publication Date
Apr 9, 2024
External Links
Slate, USPTO , Google Patents