Bone positioning and preparing guide systems and methods

Patent No. US11602387 (titled "Bone positioning and preparing guide systems and methods") on Jan 3, 2022. The application was issued on Mar 14, 2023.

What is this patent about?

’387 is related to the field of orthopedic surgery, specifically instruments and methods for correcting anatomical misalignments in the small bones of the foot. The background context involves bunion deformities, where the first metatarsal deviates from its natural position, often requiring complex surgical intervention to realign the bone and fuse the affected joint to prevent recurrence.

The underlying idea behind ’387 is that a bunion is a multi-planar deformity that is best corrected by applying a controlled force that simultaneously addresses transverse deviation and frontal plane rotation. By utilizing a mechanical guide that bridges the first and second metatarsals, a surgeon can precisely reduce the intermetatarsal angle while rotating the bone back into its proper orientation, ensuring the sesamoid bones are correctly repositioned under the metatarsal head before any permanent bone cuts are made.

The claims of ’387 focus on a metatarsal correction system that integrates three primary components: a bone positioning guide, a bone preparation guide, and fixation hardware. The independent claims specifically protect a positioning mechanism that acts on the medial side of the first metatarsal and the lateral side of a neighboring metatarsal to close the intermetatarsal angle, combined with a cutting guide that defines precise planes for tissue removal at the tarsal-metatarsal joint.

In practice, the system works by first mobilizing the joint and then applying the positioning guide to urge the first metatarsal into an anatomically aligned state. A key implementation detail involves the use of a joint spacer or seeker that indexes the bone preparation guide to the joint space, allowing the surgeon to perform parallel cuts on the metatarsal base and the medial cuneiform. This ensures that when the bones are brought together for fusion, the surfaces are perfectly apposed in the corrected orientation.

This invention differs from prior approaches by shifting the focus from simple two-dimensional bone shifting to a multi-planar correction that occurs before the bone ends are permanently modified. Unlike traditional methods that rely on freehand cuts or post-hoc adjustments, ’387 provides a stable mechanical framework that holds the corrected alignment in place, allowing for highly accurate bone preparation and rigid internal fixation that significantly reduces the risk of deformity relapse.

How does this patent fit in bigger picture?

Technical Landscape

In the mid-2010s when ’387 was filed, surgical correction of bone deformities was typically implemented using manual manipulation and static cutting blocks that required the surgeon to visualize and maintain alignment while performing osteotomies. At a time when systems commonly relied on sequential, single-plane adjustments rather than integrated multi-planar correction, achieving precise anatomical alignment across rotational and translational axes was often limited by the mechanical constraints of standard fixation clamps. Hardware constraints made the simultaneous stabilization and guided preparation of bone ends non-trivial, as traditional instruments often required removal or repositioning between the alignment and cutting phases of the procedure.

Prosecution Position

The disclosed technology achieves a technical advancement through an architectural shift in orthopedic instrumentation that integrates multi-planar bone positioning with guided end-surface preparation. By enabling a force-driven correction that simultaneously addresses translation and rotation, the system overcomes the technical constraint of maintaining complex anatomical alignment during the invasive preparation of joint surfaces for fusion. This integration allows for the preparation of bone ends, such as the first metatarsal and medial cuneiform, while the bones are held in a corrected state, ensuring that the resulting geometry of the prepared surfaces is inherently optimized for the desired final alignment.

Claims

The patent contains a total of 30 claims, with claims 1, 18, and 27 serving as the independent claims. These independent claims focus on a metatarsal correction system that integrates a bone preparation guide for cutting the first metatarsal or medial cuneiform, a positioning guide mechanism designed to adjust the intermetatarsal angle by moving the first metatarsal in at least the transverse plane, and fixation devices to secure the bone for fusion. The dependent claims serve to provide specific structural details and variations, such as the inclusion of ratchets or threaded shafts in the adjustment mechanism, specific configurations for cutting slots and fixation apertures, the use of spacers for joint placement, and the identification of particular fixation hardware like plates, screws, or staples.

Key Claim Terms New

Definitions of key terms used in the patent claims.

Term (Source)Support for SpecificationInterpretation
Bone positioning guide
(Claim 1, Claim 18)
The bone positioning guide comprises a mechanism that is operable to move the first metatarsal in at least a transverse plane to close an intermetatarsal angle. In some embodiments, the guide includes a bone engagement member and a tip positionable on a lateral side of a second metatarsal. The device is used to move a bone from an anatomically misaligned position to an anatomically aligned position with respect to another bone.A mechanical device configured to engage multiple metatarsals and apply force to move the first metatarsal from a misaligned position to an aligned position.
Bone preparation guide
(Claim 1, Claim 18)
The bone preparation guide includes a body defining a guide surface configured to be positioned over an end of a bone. The guide surface is configured to guide a tissue removing instrument for cutting the end of the bone. Embodiments include methods of using such guides to prepare an end of the first metatarsal and an opposing end of a medial cuneiform for fusion.A surgical instrument having a body with a guide surface or cutting slot designed to be positioned over a bone end to direct a tissue removing tool during a cutting procedure.
Fixation device
(Claim 1, Claim 18)
The fixation device is positionable across a tarsal-metatarsal joint separating the first metatarsal from the medial cuneiform. It is configured to fixate a moved position of the first metatarsal relative to the medial cuneiform for fusion. The system provides methods for temporarily or permanently fixing an orientation of a bone or bones.A surgical implant or hardware used to stabilize and hold the corrected position of the first metatarsal relative to the medial cuneiform to facilitate bone fusion.
Frontal plane
(Claim 27)
In some embodiments, the bone is anatomically aligned in more than one plane such that the bone both translates and rotates in response to a moving force. The system includes means for moving the first metatarsal in at least a frontal plane to adjust a frontal plane position. This allows for correcting alignment in more than one plane, such as the transverse and frontal planes.A plane of motion or orientation relating to the rotation of the bone, distinct from the transverse plane, used to adjust the rotational alignment of the metatarsal.
Intermetatarsal angle
(Claim 1, Claim 27)
The system includes a mechanism operable to move the first metatarsal to close an intermetatarsal angle between the first metatarsal and a second metatarsal. This movement corrects a bunion deformity by moving a first metatarsal from an anatomically misaligned position to an anatomically aligned position. The force moves the first metatarsal to correct an alignment in more than one plane.The angular relationship between the longitudinal axes of the first metatarsal and the second metatarsal, which is reduced during the correction of a deformity.

Litigation Cases New

US Latest litigation cases involving this patent.

Case NumberFiling DateTitle
1:25-cv-00592May 12, 2025Treace Medical Concepts, Inc. V. Zimmer Biomet Holdings, Inc.
2:24-cv-09763Oct 14, 2024TREACE MEDICAL CONCEPTS, INC. v. STRYKER CORPORATION et al

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US11602387

Application Number
US17567879A
Filing Date
Jan 3, 2022
Publication Date
Mar 14, 2023
External Links
Slate, USPTO , Google Patents