Rod coupling systems and devices and methods of making and using the same

Inventors

Nichols, JeffHarderbrook, FredIngalhalikar, AdityaFromhold, Mark

Assignees

Globus Medical Inc

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Publication Number

US-12471960-B2

Patent

Publication Date

2025-11-18

Expiration Date


Abstract

Provided are rod coupler devices, systems, kits and methods, which include at least one saddle having a concave configuration that either abuts a bone fastener and/or a locking cap and is shaped so as to contact the rod in two or more lines of contact, which reduces pressure on the rod, and therefore permits use of a rod having various materials, such as PEEK, without significant deformation of the rod. Also provided is the saddle itself and integrated locking caps that include a saddle, the locking cap and a set screw. Also provided are elongate rods having advantageous shapes, configurations, and/or compositions for rod coupler devices, systems and methods. Further provided are screw and cap devices and systems that themselves include a concave configuration so as to contact a rod in two or more lines of contact, which reduces pressure on the rod.

Core Innovation

The invention provides rod coupler systems that include a coupling body having a bone fastener disposed therethrough and at least two sidewalls defining two upwardly extending arms that form two slots capable of receiving an elongate rod. A locking cap comprising a set screw is adapted for attachment to the coupling body, and a saddle includes a first side configured to couple to or abut the locking cap and a second side having a concave portion configured to abut the elongate rod.

Prior to insertion of the saddle and locking cap into the coupling body, the saddle is selectively locked to the locking cap by rotating the saddle relative to the locking cap such that a portion of the saddle engages a groove on the locking cap. The saddle further includes a first end and a second end, where at least a portion of the first end extends into one of the two slots and at least a portion of the second end extends into the other of the two slots, thereby coupling the rod-receiving geometry to the locking interface.

The concave portion is configured to abut the elongate rod along at least two lines of contact, and in further embodiments the concave portion is shaped to substantially match the rod surface area. Embodiments also describe saddle insert concave portions at opposite ends of the elongate rod, with the saddle insert engaged with a bone fastener.

Claims Coverage

The independent claims cover rod coupler systems and coupling systems that combine a coupling body with two rod-receiving slots and a bone fastener, a saddle and locking cap that are selectively locked prior to insertion by rotating the saddle to engage a groove, and concave saddle and/or saddle insert portions that abut an elongate rod along at least two lines of contact, with optional geometric refinements.

Selective saddle-to-locking cap locking by groove engagement

Prior to insertion of the saddle and locking cap into the coupling body, the saddle is selectively locked to the locking cap by rotating the saddle relative to the locking cap such that a portion of the saddle engages a groove on the locking cap.

Two-slot coupling body with upwardly extending arms and bone fastener

A coupling body having a bone fastener disposed therethrough, the coupling body having at least two sidewalls that define two upwardly extending arms that define two slots capable of receiving an elongate rod, wherein at least a portion of the first end of the saddle extends into one of the two slots and at least a portion of the second end of the saddle extends into the other of the two slots.

Concave saddle portion creating at least two lines of contact with the elongate rod

A saddle having a second side opposite the first side having a concave portion configured to abut an elongate rod along at least two lines of contact between the saddle and the elongate rod.

Concave saddle geometry shaped to substantially match rod surface area

The saddle having a concave portion configured to abut the elongate rod, wherein the concave portion is shaped to substantially match a corresponding portion of the elongate rod’s surface area.

Radius and dimple refinements for the saddle and/or saddle insert

At least one of the saddle or the saddle insert has a radius smaller than a radius of the elongate rod, and/or at least one dimple located within a specified radius.

The claims focus on a rod coupler system in which the saddle is selectively locked to the locking cap by rotating to engage a groove before insertion, while the coupling body provides two slots and a bone fastener and the saddle concave portion abuts the elongate rod along at least two lines of contact. Additional coverage includes saddle insert geometry and optional refinements such as matching the rod surface area, using a smaller radius, and including a dimple.

Stated Advantages

Prevents plastic deformation of PEEK (and other) rods by increasing contact area.

Reduces stress risers at the rod interface.

Reduces notching/deformation.

Compatibility with PEEK rods.

Elimination of extra surgical steps via integrated components.

Documented Applications

Orthopedic spinal rod coupler systems configured to work with pedicle screw systems and receiving an elongate rod such as PEEK and related rod constructs.

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