Small bone fixation systems and methods

Inventors

Campbell, MichaelSayger, DanielHollis, Michael Chad

Assignees

Crossroads Extremity Systems LLC

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Publication Number

US-12201295-B2

Patent

Publication Date

2025-01-21

Expiration Date


Abstract

A bone fixation system can be used to stabilize two bone portions intended to be fused together. The system include a bone staple or clip that includes a cross bar and two legs. The system can include a plurality of screws or other additional implant(s) configured to be implanted at an angle to the legs of the bone staple on opposite sides of the interface between two bone portions. The system can improve fixation strength and/or stability of the two bone portions. The fixation system can be used, for example, in small bones such as bones in the foot or hand.

Core Innovation

The disclosed invention relates to small-bone fusion and stabilization systems that fix bone portions defined by a discontinuity in a bone or fix two bones across a joint. The method delivers a first elongate implant on a first side of the discontinuity or joint and a second elongate implant on a second side of the discontinuity or joint, and delivers a clip into the bones or bone portions so that a first leg is on the first side, a second leg is on the second side, and a bridge connects first ends of the legs extending across the discontinuity or joint.

The clip is biased to be in a first configuration and is delivered in a second deformed configuration. Delivering the clip in the second deformed configuration increases a distance between free ends of the first and second legs relative to the first configuration, and the first elongate implant is positioned between the first leg of the clip and the discontinuity or joint while the second elongate implant is positioned between the second leg of the clip and the discontinuity or joint.

The system further includes delivery and positioning structures that support the clip and elongate implants relative to the discontinuity or joint. The document describes using a clip drill guide across a discontinuity or joint, drilling and forming clip leg holes on both sides, and using an implant guide having multiple guide positioning holes and multiple implant positioning holes, including an arc-shaped implant guide with implant positioning holes and guide positioning holes passing through the arc-shaped implant guide at varying angles.

Claims Coverage

The independent claim covers a bone-fixing method with three core inventive actions: delivering elongate implants to opposite sides of a bone discontinuity or joint, delivering an elastically biased clip across the discontinuity or joint with a bridge, and delivering the clip in a second deformed configuration that increases the spacing between clip leg free ends, with each elongate implant positioned between a respective clip leg and the discontinuity or joint. Dependent claims further narrow the method and specify guidance/drill workflows and geometric constraints.

Elongate implants on opposite sides with across-discontinuity clip bridge

Delivering a first elongate implant into a bone or bone portion on a first side of the discontinuity or joint; delivering a second elongate implant into a bone or bone portion on a second side of the discontinuity or joint; and delivering a clip into the bones or bone portions, the first leg of the clip on the first side, the second leg on the second side, and a bridge connecting first ends of the first and second legs extending across the discontinuity or joint.

Biased clip delivered in deformed configuration to increase leg free-end spacing

Wherein the clip is biased to be in a first configuration and wherein the clip is delivered in a second deformed configuration such that a distance between free ends of the first and second legs of the clip is increased relative to the first configuration.

Elongate implants positioned between clip legs and discontinuity or joint

Wherein the first elongate implant is positioned between the first leg of the clip and the discontinuity or joint and the second elongate implant is positioned between the second leg of the clip and the discontinuity or joint.

Do not cross discontinuity when delivering elongate implants

The method includes delivering the first and second elongate implants without crossing a discontinuity.

Clip drill guide and implant guide hole-forming and clip-leg insertion workflow

Positioning a clip drill guide across a discontinuity or joint, drilling and pinning clip leg holes on both sides; using an implant guide with plurality of guide positioning holes and plurality of implant positioning holes to create implant holes closer to the joint; inserting implants into the holes; removing temporary pins; and finally inserting the clip legs into the respective drilled leg holes.

Implant positioning holes smaller than guide positioning holes

Specifying that the implant positioning holes have a smaller diameter than the guide positioning holes.

Arc-shaped implant guide with varying-angle hole passage

Configuring the implant guide as arc-shaped, with implant positioning holes and guide positioning holes passing through the arc-shaped implant guide at varying angles.

Elongate implant length selected for bicortical purchase

Providing that the first and second elongate implants each have a length greater than a length of the first or second legs such that the first and second elongate implants are each configured to achieve bicortical purchase.

Across the independent claim and its refinements, the core coverage centers on delivering elongate implants to opposite sides of a bone discontinuity or joint and deploying a biased clip across the discontinuity or joint with a bridge, where the clip is delivered in a deformed configuration that increases the distance between free ends of the clip legs. Dependent claims further specify non-crossing implant delivery, a guide-and-drill workflow using clip drill guides and implant guides with temporary pins, and geometric constraints such as diameter relationships, arc-shaped guide geometry with varying angles, and elongate implant length for bicortical purchase.

Stated Advantages

Improved fixation strength and stability.

Potentially faster healing.

Potentially avoids crossing the discontinuity using implants in limited cortical space scenarios.

Documented Applications

Small-bone fusion/stabilization for foot/hand small bones.

Fixing bone portions defined by a discontinuity in a bone and fixing two bones across a joint.

Use in limited cortical space scenarios where implants may avoid crossing the discontinuity.

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