FIELD OF THE INVENTION

The invention relates to a drill guide assembly for use assembly for use with a room temperature superelastic U-shaped Nitinol staple used for bone fixation, which has a compression or distraction aspect, and which accepts a cartridge for the staple leg drill guide so as to allow the drill guide to be used with various configuration and size staples.

BACKGROUND OF THE INVENTION

Over 1.8 million orthopedic trauma fixation procedures were performed in the US in 2016, and the market is expected to reach over $4 billion by 2025. The fastest growing part of the market is the staple fixation segment, which is also expected to remain the fastest growing through to 2025. The primary drivers for growth are reportedly a reduced operating time as compared to screws, and plates.

While the state of the art has advanced the use of bone staples, there remain issues in the use and design of the instruments designed for the surgical implantation of surgical procedures while taking inventory concerns into consideration. Thus, the invention relates to a drill guide that can be used for a variety of staple models, and which doubles as a tool to affect compression between bone segments to help induce fusion when the staple is deployed.

SUMMARY OF THE INVENTION

The invention provides a drill guide assembly for a superelastic compressive bone staple. The staple has a bridge member that extends a length along an axis and which joins two or more legs spaced apart along the axis and is fabricated in a closed (converging legs) shape and is mechanically deformed or “activated” by the inserter during use to induce the superelastic shape memory properties. This allows the staple to compress bone segments. The drill guide assembly includes a compressor/distractor that has a lateral movement mechanism that spreads apart or contracts the flange ends of the drill guide which are supported by k-wires toward each other and makes room for the staple drill guide cartridge that is captured in an appropriate keyed recess in the drill guide body.

The staple of the present invention is configured to accommodate fixation procedures in the forefoot, midfoot, rearfoot and hand, and the inserter (which can be disposable) allows implantation of the staple in bone in a surgical procedure so as to apply a compressive force across a division of bone segments. A preferable configuration for the bone staple is a substantially U-shaped staple, i.e. a staple having a transverse bridge member and downwardly extending legs (one or more pairs), which can be biased into a parallel “activated position” for insertion into the bone, and then released into a compressive configuration.

The invention also relates to a drill guide/compression device that includes a laterally opposed pair of k-wire channels and a mechanism that compresses or expands the set of k-wire tips laterally. The drill guide body further has a complex opening that forms a clip to secure a drill cartridge in the opening so that various pilot holes can be drilled using a single drill guide body.

