Patent No. US12268397 (titled "Bone Cutting Guide Systems And Methods") was filed by Treace Medical Concepts Inc on Apr 24, 2024.
’397 is related to the field of bone surgery, specifically devices and methods for guiding bone cuts during procedures like bunion corrections (e.g., Lapidus procedure) or basilar metatarsal osteotomies. The background acknowledges that bones, particularly in the foot, can be misaligned, necessitating surgical intervention to improve patient comfort and quality of life. Current surgical techniques may lack precision and require improved tools for accurate bone cutting and alignment.
The underlying idea behind ’397 is to provide a modular and adjustable bone cutting guide that allows surgeons to make precise cuts on bones, realign them, and then facilitate fusion. The key inventive insight is the use of a translating shaft within a support structure, enabling the surgeon to adjust the position of the cutting guide relative to the bone without moving the entire device. This, combined with optional bridging and secondary guide members, allows for complex, multi-planar cuts and precise bone positioning.
The claims of ’397 focus on a bunion correction method using a bone cutting guide. The method involves positioning a first cutting guide slot over a metatarsal, attaching the guide with fixation pins, cutting the metatarsal, adjusting the metatarsal's alignment relative to a cuneiform, positioning a second cutting guide slot over the cuneiform, attaching the second guide, cutting the cuneiform, and fusing the bones in the new position. The claims emphasize the use of parallel fixation pins and the ability to lift and reposition the guide between cuts.
In practice, the surgeon first fixates the support to a bone using pins. The main guide member , attached to the translating shaft, is then positioned at the desired cut location. The surgeon can adjust the shaft's position to fine-tune the cut location. After making the first cut, a bridge component can be attached to the main guide member, spanning the joint between the metatarsal and cuneiform. A fixating structure on the bridge allows for controlled compression or expansion of the joint space.
The invention differentiates itself from prior approaches by offering a more versatile and adjustable cutting guide. The translating shaft mechanism allows for precise positioning of the cutting guide without repositioning the entire device. The optional bridge component and secondary guide member enable more complex procedures involving multiple cuts and controlled joint manipulation. This modularity and adjustability aim to improve the accuracy and efficiency of bone cutting and alignment procedures compared to traditional methods.
In the mid-2010s when ’397 was filed, bone cutting guides were at a time when surgical procedures commonly relied on manual alignment and cutting techniques. Hardware constraints made precise and repeatable bone cuts non-trivial, and systems commonly relied on visual inspection and tactile feedback rather than automated guidance.
The examiner approved the application because the prior art, whether considered individually or in combination, did not disclose a method for bunion correction that involves attaching a first cut guide over a metatarsal using first and second fixation pins located distally to the cutting guide, cutting the bone, positioning a second cut guide over a cuneiform and attaching it to the metatarsal using the same fixation pins, cutting the bone, and fusing the cuneiform and metatarsal.
This patent contains 30 claims, of which claims 1, 20, and 29 are independent. The independent claims focus on methods for bunion correction involving cutting and fusing a metatarsal and cuneiform. The dependent claims generally elaborate on specific aspects, features, or steps of the methods described in the independent claims.
Definitions of key terms used in the patent claims.
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