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Publication Number

US-12035951-B1

Patent

Publication Date

2024-07-16

Expiration Date


Abstract

Orthopedic implants for fixation of bone fractures to provide increase purchase of the orthopedic implant within specific regions of the repaired bone. Orthopedic accessory tools such as drill bits and multi-functional orthopedic sizing tools. Kits containing such orthopedic devices and methods for the use of such orthopedic implants, drill bits, and orthopedic tools.

Core Innovation

The orthopedic stabilization implant is described for use with an orthopedic tool and for implanting in a region of tissue having varying cross-sectional areas. The implant comprises an implant shaft with a distal region terminating at a distal tip and a proximal region terminating at a proximal end. A cannulated passage extends fully through the implant shaft, and a drive recess within the proximal end is configured to receive a drive structure of the orthopedic tool.

The implant includes a first thread structure having a first major diameter and a first pitch. The first thread structure extends helically starting adjacent to the distal tip, over the distal region and over the proximal region, with the first pitch consistent over the distal region and the proximal region. The implant also includes a second thread structure having a second major diameter and a second pitch that extends helically only along the proximal region, starting adjacent the proximal end to adjacent the distal region, and the second thread structure is spaced from the first thread structure along the proximal region.

In the proximal region, the first major diameter and the second major diameter are constant, and the first major diameter increases in a distal-to-proximal direction in the distal region from adjacent the distal tip to adjacent the proximal region. Variations include self-tapping recess interruptions, spaced threads with an optional 180° out-of-phase arrangement, and a distal tip configured to cut hard tissue. The disclosed kit and accessory concepts include orthopedic sizing tools and orthopedic accessory tools configured for selecting implant diameter and length for non-invasive imaging-based diameter selection using radiopaque sizing surfaces.

Claims Coverage

The independent claim coverage centers on an orthopedic stabilization implant having a cannulated implant shaft with a proximal tool drive recess and a two-thread helical arrangement tailored to tissue regions having varying cross-sectional areas. The main inventive features include a first helical thread spanning the distal and proximal regions, a second helical thread limited to the proximal region and spaced from the first thread, and specific proximal/distal major diameter relationships alongside a diameter/pitch consistency requirement.

Two-region helical thread architecture for varying tissue cross-sectional areas

An implant with a first thread structure extending helically from adjacent the distal tip over the distal region and over the proximal region with a consistent first pitch, and a second thread structure extending helically only along the proximal region from adjacent the proximal end to adjacent the distal region, where the second thread structure is spaced from the first thread structure along the proximal region.

Proximal constant diameters and distal-to-proximal increasing first major diameter

In the proximal region, the first major diameter and the second major diameter are constant, and the first major diameter increases in a distal-to-proximal direction in the distal region from adjacent the distal tip to adjacent the proximal region.

Cannulated implant shaft and proximal tool drive recess

A cannulated passage extending fully through the implant shaft and a drive recess within the proximal end configured to receive a drive structure of the orthopedic tool.

Across the independent claim, the implant is defined by a cannulated implant shaft with a proximal drive recess for an orthopedic tool, a first helical thread with consistent pitch spanning distal and proximal regions, and a second helical thread limited to the proximal region and spaced from the first thread, combined with constant proximal diameters and a distal-to-proximal increase of the first major diameter within the distal region.

Stated Advantages

Improving purchase/grip in the metacarpal head/neck while minimizing unwanted compressive force during insertion.

Documented Applications

Metacarpal fracture fixation, including metacarpal head/neck application as shown in example metacarpal application images.

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