Bone Positioning Guide

Patent No. US12102368 (titled "Bone Positioning Guide") was filed by Treace Medical Concepts Inc on Apr 5, 2024.

’368 is related to the field of bone positioning and, more specifically, to devices and techniques for correcting bone misalignments, particularly in the foot. The background highlights the challenges of manually realigning bones during surgical procedures, often leading to inconsistent results. The patent aims to provide a more controlled and precise method for bone realignment and fixation.

The underlying idea behind ’368 is to provide a bone positioning guide that allows a surgeon to realign a misaligned bone, such as the first metatarsal in a bunion correction, in multiple planes simultaneously. This is achieved by using a device with a bone engagement member that contacts one bone and a tip that contacts another. By moving the bone engagement member relative to the tip, the device applies a controlled force to realign the first bone with respect to the second.

The claims of ’368 focus on a metatarsal bunion correction system that includes a bone preparation guide and a bone positioning guide. The bone preparation guide has a surface to guide a tissue-removing instrument for cutting the first metatarsal and/or medial cuneiform. The bone positioning guide moves the first metatarsal in the transverse plane to reduce the intermetatarsal angle and rotates it in the frontal plane. At least one fixation device is used to fixate the moved position of the first metatarsal relative to the medial cuneiform for fusion.

In practice, the surgeon would first use the bone positioning guide to realign the first metatarsal, correcting both the intermetatarsal angle and any axial rotation. A fixation wire inserted into the second metatarsal and extending through an opening in the bone positioning guide can be used to maintain the position. A pin inserted into the first metatarsal can receive a force to rotate the first metatarsal in the frontal plane. Then, the bone preparation guide is used to prepare the surfaces of the first metatarsal and medial cuneiform for fusion, ensuring proper contact and alignment. Finally, a fixation device, such as a bone plate, is applied to permanently fix the bones in their corrected position.

The system differentiates itself from prior approaches by providing a controlled and multi-planar correction of bone misalignments. The combination of the bone positioning guide and bone preparation guide allows for a more precise and predictable surgical outcome. The use of a fulcrum can further enhance the realignment process by minimizing base compression and improving the cut angle. The system also allows for the use of a joint spacer to ensure proper positioning of the bone preparation guide.

How does this patent fit in bigger picture?

Technical landscape at the time

In the mid-2010s when ’368 was filed, bone realignment procedures were typically implemented using manual techniques, at a time when hardware or software constraints made precise, three-dimensional bone positioning non-trivial. At that time, surgeons commonly relied on their skill to realign bones and then fixate them in the corrected position, when systems commonly relied on manual alignment rather than guided alignment.

Novelty and Inventive Step

The examiner approved the application because the prior art, including Lawrence et al. and Lewis et al., disclosed a metatarsal bunion correction system with a bone preparation guide. However, the prior art failed to teach or suggest the specific structural relationship where the bone positioning guide could move the metatarsal in a transverse plane to reduce the intermetatarsal angle, rotate the metatarsal in a frontal plane, and use a fixation device positionable across the tarsal-metatarsal joint to fixate the moved position of the metatarsal relative to the medial cuneiform for fusion.

Claims

This patent includes 30 claims, with independent claims 1 and 21. The independent claims are directed to a metatarsal bunion correction system that includes a bone preparation guide and a bone positioning guide. The dependent claims generally add further details and features to the system described in the independent claims.

Key Claim Terms New

Definitions of key terms used in the patent claims.

Term (Source)	Support for Specification	Interpretation
Bone positioning guide (Claim 1, Claim 21)	“In general, the present disclosure is directed to bone positioning guides and techniques for using the bone positioning guides. In some examples, a bone positioning guide includes a main body that has a first terminal end and a second terminal end. The main body can wrap or bend about itself such that the first terminal end faces the second terminal end with a bone realignment space defined between the first terminal end and the second terminal end.”	A guide configured to move the first metatarsal to treat a bunion deformity by moving the first metatarsal in a transverse plane to reduce an intermetatarsal angle between the first metatarsal and a second metatarsal, and rotating the first metatarsal in a frontal plane.
Fixation device (Claim 1, Claim 21)	“After advancing the bone engagement member relative to the tip to a location where suitable realignment is achieved (e.g., as determined by the clinician performing the procedure), 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 in the realigned position while the bone positioning guide holds the first metatarsal in the realigned position.”	A device positionable across a tarsal-metatarsal joint separating the first metatarsal from the medial cuneiform, the at least one fixation device being configured to fixate a moved position of the first metatarsal relative to the medial cuneiform for fusion.
Guide surface (Claim 1, Claim 21)	“Embodiments of the invention include a bone positioning guide and method of positioning bones in a medical procedure. In an exemplary application, 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).”	A surface on the bone preparation guide body that directs a tissue removing instrument to cut the proximal end of the first metatarsal and/or the distal end of the medial cuneiform.
Intermetatarsal angle (Claim 1, Claim 21)	“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), such as in a bunion correction surgery.”	The angle between the first metatarsal and a second metatarsal.
Spacer (Claim 21)	“In an exemplary application, 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). Such a procedure can be performed, for example, on bones (e.g., adjacent bones separated by a joint or different portions of a single bone) in the foot or hand, where bones are relatively smaller compared to bones in other parts of the human anatomy.”	A component extending downwardly from the body of the bone preparation guide and configured to be placed into a tarsal-metatarsal joint separating the first metatarsal from the medial cuneiform.

Litigation Cases New

US Latest litigation cases involving this patent.

Case Number	Filing Date	Title
1:25-cv-00592	May 12, 2025	Treace Medical Concepts, Inc. V. Zimmer Biomet Holdings, Inc.

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US12102368

TREACE MEDICAL CONCEPTS INC

Application Number: US18627609
Filing Date: Apr 5, 2024
Status: Granted
Expiry Date: Dec 28, 2035
External Links: Slate, USPTO, Google Patents

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