Tarsal-Metatarsal Joint Procedure Utilizing Fulcrum

Patent No. US12268428 (titled "Tarsal-Metatarsal Joint Procedure Utilizing Fulcrum") was filed by Treace Medical Concepts Inc on Apr 25, 2024.

What is this patent about?

’428 is related to the field of surgical instruments and techniques for correcting bone deformities, specifically bunions. Bunions are misalignments of the bones in the foot, often involving the first metatarsal. Surgical intervention aims to realign these bones to alleviate pain and improve the patient's quality of life. Current surgical methods can be complex and may not always achieve optimal alignment in all planes.

The underlying idea behind ’428 is to use a combination of instruments and techniques to achieve a more precise and controlled correction of bunion deformities. This involves using an instrument, such as a fulcrum , inserted between the first and second metatarsals to act as a pivot point during realignment. Bone preparation guides and positioning guides are used to ensure accurate bone cuts and controlled movement of the first metatarsal in multiple planes.

The claims of ’428 focus on instrumented surgical techniques for treating bunion deformities. These techniques involve inserting an instrument (e.g., a fulcrum) between the first and second metatarsals, cutting the end of the first metatarsal and the opposing end of the medial cuneiform, moving the first metatarsal in at least one plane to correct the deformity, and then fixating the corrected position of the first metatarsal relative to the medial cuneiform using bone fixation devices. Some claims specify the use of a bone preparation guide with a cutting slot and a bone positioning guide to move the first metatarsal in the transverse plane.

In practice, the surgeon first mobilizes the joint and then inserts the fulcrum between the metatarsals. A bone preparation guide is positioned, and the ends of the first metatarsal and medial cuneiform are cut to prepare them for fusion. The surgeon then uses the fulcrum as a pivot point to move the first metatarsal into the correct alignment, correcting both the intermetatarsal angle and any rotational deformity. The bone positioning guide assists in controlling this movement, and fixation pins may be used to temporarily hold the bones in place.

This approach differs from prior methods by providing a more controlled and precise way to realign the bones. The fulcrum helps to prevent base compression and lateral translation of the metatarsal, while the bone preparation guide ensures accurate bone cuts. The bone positioning guide allows for controlled movement of the first metatarsal in multiple planes, leading to a more anatomically correct and stable correction of the bunion deformity. The combination of these instruments and techniques aims to improve surgical outcomes and reduce the risk of recurrence.

How does this patent fit in bigger picture?

Technical landscape at the time

In the mid-2010s when ’428 was filed, surgical procedures for bone realignment, particularly in the foot, were at a time when surgeons commonly relied on mechanical instruments and fixation devices to correct anatomical misalignments. At a time when X-ray imaging was typically used for intraoperative assessment, hardware or software constraints made precise, multi-planar bone positioning non-trivial.

Novelty and Inventive Step

The examiner approved the application because the prior art, while disclosing instrumented surgical techniques for bunion deformity treatment involving cutting a metatarsal, moving a distal portion of the metatarsal, and using bone fixation, did not teach or disclose cutting an end of the medial cuneiform opposing the end of the first metatarsal, moving the first metatarsal in at least one plane to treat the bunion deformity, and fixating the moved position of the first metatarsal relative to the medial cuneiform using at least one bone fixation device.

Claims

This patent contains 30 claims, with independent claims numbered 1, 18, and 28. The independent claims are directed to instrumented surgical techniques for treating bunion deformities, involving cutting and moving the first metatarsal and medial cuneiform, and fixating their position. The dependent claims generally elaborate on or further define the steps and features described in the independent claims.

Key Claim Terms New

Definitions of key terms used in the patent claims.

Term (Source)Support for SpecificationInterpretation
Bone positioning guide
(Claim 28)
“Embodiments of the present invention include methods for fixing an orientation of a bone or bones. In general, the method of positioning a bone includes the steps of moving a bone from an anatomically misaligned position to an anatomically aligned position with respect to another bone and preparing an end of the bone and a facing end of another bone.”A guide that engages with the first metatarsal and is used to move the first metatarsal relative to the second metatarsal in a transverse plane to reduce an intermetatarsal angle.
Bone preparation guide
(Claim 18, Claim 28)
“Embodiments of the present invention include methods for fixing an orientation of a bone or bones. In general, the method of positioning a bone includes the steps of moving a bone from an anatomically misaligned position to an anatomically aligned position with respect to another bone and preparing an end of the bone and a facing end of another bone.”A guide that defines a cutting slot and has at least one fixation aperture for receiving a fixation pin inserted into the first metatarsal.
Cutting slot
(Claim 18, Claim 28)
“Embodiments of the present invention include methods for fixing an orientation of a bone or bones. In general, the method of positioning a bone includes the steps of moving a bone from an anatomically misaligned position to an anatomically aligned position with respect to another bone and preparing an end of the bone and a facing end of another bone.”A slot in a bone preparation guide through which a saw blade is guided to cut an end of the first metatarsal.
Fixation aperture
(Claim 18, Claim 28)
“Embodiments of the present invention include methods for fixing an orientation of a bone or bones. In general, the method of positioning a bone includes the steps of moving a bone from an anatomically misaligned position to an anatomically aligned position with respect to another bone and preparing an end of the bone and a facing end of another bone.”An aperture of the bone preparation guide through which a fixation pin inserted into the first metatarsal extends.
Medial cuneiform
(Claim 1, Claim 18, Claim 28)
“The method includes inserting a fulcrum between a first metatarsal and a second metatarsal, where the first metatarsal is anatomically misaligned with respect to the second metatarsal. The method further includes preparing an end of the first metatarsal and preparing an end of a medial cuneiform opposing the end of the first metatarsal.”A bone that has an end cut to oppose the end of the first metatarsal.

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.

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US12268428

TREACE MEDICAL CONCEPTS INC
Application Number
US18645596
Filing Date
Apr 25, 2024
Status
Granted
Expiry Date
Dec 28, 2035
External Links
Slate, USPTO, Google Patents