Metatarsophalangeal Joint Preparation And Metatarsal Realignment For Fusion

Patent No. US11622797 (titled "Metatarsophalangeal Joint Preparation And Metatarsal Realignment For Fusion") was filed by Midcap Funding Iv Trust on Jan 29, 2021.

What is this patent about?

’797 is related to the field of orthopedic surgery, specifically addressing procedures for metatarsophalangeal (MTP) joint fusion and metatarsal realignment. The background involves conditions like Hallux rigidus and Hallux valgus, which cause pain and limited mobility in the foot due to misalignment and degeneration of the MTP joint. Current treatments often involve surgically fusing the metatarsal and phalanx, but achieving proper alignment can be challenging.

The underlying idea behind ’797 is to provide a method for more precisely realigning the metatarsal and phalanx before fusion. This involves surgically accessing the MTP joint, separating the bones, preparing the bone surfaces for fusion, and then independently manipulating the metatarsal and phalanx in multiple planes to achieve optimal anatomical alignment. The aligned bones are then fixed together to promote fusion.

The claims of ’797 focus on a method of preparing an MTP joint for fusion. Claim 1 covers surgically accessing the joint, preparing the ends of the metatarsal and phalanx, moving the metatarsal in at least two planes to a desired position, and then applying a bone fixation device. Claim 25 adds the step of using a bone positioning guide to move the metatarsal, engaging the metatarsal and another bone.

In practice, the surgeon makes an incision to access the MTP joint and separates the metatarsal from the phalanx. The ends of the bones are then prepared by reaming or other techniques to expose subchondral bone. A key step involves using a bone positioning guide, which is attached to the metatarsal and another bone (e.g., an adjacent metatarsal or cuneiform). By actuating the guide, the surgeon can move the metatarsal in the transverse and frontal planes to correct misalignments like an increased intermetatarsal angle or rotational deformities.

The method differentiates itself from prior approaches by providing a more controlled and precise way to realign the bones. Traditional methods often rely on manual manipulation, which can be less accurate and repeatable. By using a bone positioning guide, the surgeon can achieve a more consistent and anatomically correct alignment, potentially leading to better fusion outcomes and improved patient function. The use of a provisional fixation pin through the phalanx to set sagittal alignment before frontal plane adjustment is also a key differentiator.

How does this patent fit in bigger picture?

Technical landscape at the time

In the early 2020s when ’797 was filed, surgical procedures at a time when bone realignment was typically implemented using manual techniques and external fixation devices. Hardware or software constraints made precise, repeatable, and instrumented realignment non-trivial.

Novelty and Inventive Step

The examiner allowed the claims because no prior art references, either individually or in combination, disclosed or suggested a method of preparing a metatarsophalangeal joint for fusion that includes surgically accessing the joint, preparing the ends of the metatarsal and phalanx, moving the metatarsal in at least two planes to establish a moved position, and applying a bone fixation device. While Stone discloses the claimed invention, it does not disclose applying at least one bone fixation device across and through the metatarsophalangeal joint separating the metatarsal from the opposed proximal phalanx.

Claims

This patent contains 25 claims, with independent claims numbered 1 and 25. The independent claims are directed to methods of preparing a metatarsophalangeal joint for fusion, involving surgical access, bone preparation, repositioning, and fixation. 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 fixation device
(Claim 1, Claim 25)
“With the metatarsal and proximal phalanx each independently realigned relative to each other, one or more fixation devices can be applied across and/or through the MTP joint to promote subsequent fusion of the bones. For example, one or more plates, screws, pins, and/or the like can be applied to permanently fixate the metatarsal to the phalanx and promote fusion of the bones at the MTP joint.”A device that is applied across or through the metatarsophalangeal joint to fixate the metatarsal to the phalanx and promote fusion of the bones.
Bone positioning guide
(Claim 25)
“In one example, the clinician engages a bone positioner with the metatarsal and a bone other than the metatarsal. The bone positioner can then be actuated to move the metatarsal in one or more planes for realignment. The use of the bone positioner can provide an instrumented approach to metatarsal realignment that allows for repeatable, consistent clinical outcomes patient-to-patient and clinician-to-clinician.”A device that is engaged with the metatarsal and another bone to move the metatarsal in at least one plane.
Moved position
(Claim 1, Claim 25)
“According to some example implementations of the devices and techniques described herein, the metatarsal and phalanx separated by the MTP joint can be independently realigned relative to each other. For example, the position of the metatarsal in three-dimensional space may first be adjusted to a desired moved position and provisionally held in that moved position during subsequent realignment of the phalanx.”A new position of the metatarsal after it has been moved in at least one or two planes.
Opposed proximal phalanx
(Claim 1, Claim 25)
“In general, this disclosure is directed to devices and techniques for preparing the metatarsophalangeal (“MTP”) joint for fusion and realigning the metatarsal and phalanx separated by the joint. In some implementations, a clinician surgically accesses the MTP joint and separates the metatarsal from the opposed phalanx for subsequent bone preparation and realignment.”The phalanx that is on the opposite side of the metatarsophalangeal joint from the 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.
2:24-cv-09763Oct 14, 2024TREACE MEDICAL CONCEPTS, INC. v. STRYKER CORPORATION et al

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US11622797

MIDCAP FUNDING IV TRUST
Application Number
US17163120
Filing Date
Jan 29, 2021
Status
Granted
Expiry Date
Oct 10, 2041
External Links
Slate, USPTO, Google Patents