Patent No. US12274481 (titled "Bone Positioning And Preparing Guide Systems And Methods") was filed by Treace Medical Concepts Inc on Feb 26, 2024.
’481 is related to the field of surgical instruments and methods for bone positioning and preparation, specifically addressing the correction of bunion deformities. The background involves the surgical realignment of bones, particularly in the foot, to alleviate discomfort and improve the patient's quality of life when bones are anatomically misaligned. This often requires precise positioning and preparation of the bone surfaces for fusion.
The underlying idea behind ’481 is to provide a guided surgical technique for correcting bunion deformities by using a bone positioning guide to realign the first metatarsal with respect to the second metatarsal and the medial cuneiform. This involves applying a controlled force to the first metatarsal to achieve multi-planar correction (transverse and frontal planes) and preparing the bone surfaces for fusion using a bone preparation guide to ensure proper contact and alignment.
The claims of ’481 focus on an instrumented surgical technique that involves making incisions to access the tarsal-metatarsal joint, engaging the first metatarsal with a bone engagement member, and using a bone positioning guide to reduce the intermetatarsal angle. The claims also cover cutting the ends of the first metatarsal and medial cuneiform, adjusting the alignment in the frontal plane using a pin, compressing the bones together, and fixating their position for fusion using bone fixation devices.
The invention works by first providing surgical access to the joint and then using the bone positioning guide to apply a controlled force to the first metatarsal. This force moves the bone laterally and rotates it to correct the bunion deformity in both the transverse and frontal planes. A pin inserted into the first metatarsal allows for fine-tuning the alignment in the frontal plane. After the bones are properly aligned, a bone preparation guide is used to cut the ends of the first metatarsal and medial cuneiform, preparing them for fusion. Finally, the bones are compressed and fixated using bone plates or other fixation devices.
This approach differs from traditional methods by providing a guided and controlled way to achieve multi-planar correction of the bunion deformity. The use of a bone positioning guide allows for precise application of force and rotation, while the bone preparation guide ensures accurate cutting of the bone surfaces for optimal fusion. The combination of these tools and techniques aims to improve the accuracy and effectiveness of bunion correction surgery, leading to better patient outcomes by simultaneously correcting transverse and frontal plane deformities .
In the mid-2010s when ’481 was filed, at a time when surgical procedures commonly relied on manual alignment and preparation of bones, hardware or software constraints made precise, multi-planar bone positioning and preparation non-trivial. Systems commonly relied on visual inspection and tactile feedback rather than automated or guided alignment techniques. At this time, surgical guides were typically implemented using physical templates and mechanical fixtures.
The examiner approved the application because the prior art did not teach or disclose the specific steps of the claimed instrumented surgical technique. Specifically, the prior art failed to disclose rotating a knob connected to a threaded shaft of a bone positioning guide to push the first metatarsal laterally toward the second metatarsal, reducing the intermetatarsal angle to correct a bunion deformity. Furthermore, the prior art did not disclose imparting a force to a pin inserted into the first metatarsal to adjust its alignment in a frontal plane, cutting an end of the medial cuneiform with a tissue removing instrument, compressing the first metatarsal together with the medial cuneiform, and fixating a moved position of the first metatarsal relative to the medial cuneiform for fusion using at least one bone fixation device.
This patent contains 30 claims, with independent claims numbered 1, 14, 27, and 30. The independent claims are directed to instrumented surgical techniques for correcting bunion deformities and preparing a tarsal-metatarsal joint for fusion. The dependent claims generally add further detail and limitations to the steps recited in the independent claims.
Definitions of key terms used in the patent claims.
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