SURGICAL DEVICES FOR SMALL BONE FRACTURE SURGERY
Small bone surgical nail devices and methods for use m small hone fracture surgeries, for example, clavicle fracture surgery. The systems and methods can include a nail device with specific design features including, but not limited to differing designs, geometries, and configurations in multiple zones of the device, an associated optional end cap, and/or optional locking screws.
1 . A nail fixation system, the system comprising:
a nail sized for positioning within a clavicle or other bone, the nail comprising an elongate shaft having a proximal end and a distal end, the nail comprising multiple zones along its length having various cross-sectional geometries;
wherein:
the nail comprises an end zone at its distal end having a first cross-sectional shape and a shaft zone proximal to the end zone having a second cross-sectional shape, wherein the first cross-sectional shape is different from the second cross-sectional shape;
the nail comprises a transition zone between the end zone and the shaft zone;
the transition zone has a third cross-sectional shape that is different from the first cross-sectional shape and the second cross-sectional shape;
the shaft zone has a cross sectional area greater than or equal to a cross sectional area of the transition zone and the cross sectional area of the transition zone is greater than or equal to a cross sectional area of the end zone; and
the transition zone has a length of at least 1 mm.
2 . The system of claim 1 , wherein the nail comprises an end zone at its distal end having a first cross-sectional shape and a shaft zone proximal to the end zone having a second cross-sectional shape, wherein the first cross-sectional shape is different from the second cross-sectional shape.
3 . The system of claim 2 , further comprising a transition zone between the end zone and the shaft zone, wherein the transition zone has a third cross-sectional shape.
4 . The system of claim 2 , wherein at least the end zone has a non-circular cross section.
5 . The system of claim 3 , wherein the end zone, transition zone, and shaft zone comprise a non-circular cross section.
6 . The system of claim 2 , wherein the shaft zone has a larger cross-sectional area than the end zone.
7 . The system of claim 3 , wherein the shaft zone has a cross sectional area greater than or equal to a cross sectional area of the transition zone and wherein the cross sectional area of the transition zone is greater than or equal to a cross sectional area of the end zone.
8 . The system of claim 1 , wherein the proximal end of the nail has a round-cross section.
9 . The system of claim 1 , wherein the nail comprises an anterior surface sized and configured to face an anterior side of the clavicle bone and a posterior surface sized and configured to face a posterior side of the clavicle bone, and wherein the nail is bent or curved toward either the anterior surface or the posterior surface.
10 . The system of claim 9 , wherein at least a portion of either the anterior surface or the posterior surface is flat.
11 . The system of claim 1 , wherein the distal end of the nail has at least one sharp edge.
12 . The system of claim 2 , wherein the end zone comprises a cutting geometry configured to create a path through the medullary canal of the bone, the cutting geometry comprising a curvature on at least one edge of the end zone toward the distal end of the device configured to create a sharp distal end.
13 . The system of claim 1 , wherein a distal portion of the nail has a cross-section with four flat sides.
14 . The system of claim 1 , wherein the nail has a first cross-section with a plurality of flat surfaces and a second cross-section with a single flat surface, wherein the second cross section is proximal to the first cross-section.
15 . The system of claim 14 , wherein the transition zone is configured to provide at least one transitional cross section between the first cross-section with a plurality of flat surfaces and the second cross-section with a single flat surface.
16 . The system of claim 1 , further comprising an end cap at or configured to engage the proximal end of the nail.
17 . The system of claim 16 , wherein the proximal end of the nail is externally threaded and a distal portion of the end cap is internally threaded for attachment to the externally threaded proximal end.
18 . The system of claim 16 , wherein the end cap is crimped or welded onto the proximal end of the nail.
19 . The system of claim 16 , wherein the end cap comprises a plurality of retractable and expandable wings for engagement with bone.
20 . The system any one of claim 16 , wherein a proximal portion of the end cap is internally threaded to receive a screw extractor.
21 . (canceled)
22 . (canceled)