Patent No. US11622797 (titled "Metatarsophalangeal Joint Preparation And Metatarsal Realignment For Fusion") was filed by Midcap Funding Iv Trust on Jan 29, 2021.
’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.
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.
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.
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.
Definitions of key terms used in the patent claims.
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