Systems, devices, and methods for joint fusion

Inventors

Mauldin, Richard G. • Rashbaum, Ralph F. • Reiley, Mark A. • Yerby, Scott A. • Sand, Paul M. • SCHNEIDER, Bret W. • Rodriguez, Jose • Domingo, Nicanor • Leung, Joanne

Assignees

SI Bone Inc

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Publication Number

US-12213886-B2

Patent

Publication Date

2025-02-04

Expiration Date


Abstract

The present invention relates generally to implants and tools for the fixation or fusion of joints or bone segments. These tools include tissue dilators and protectors. Other tools include broaches used to shape bores in bone. The tools can also include a system for removing an implant from bone. Implants can include assemblies of one or more implant structures that make possible the achievement of diverse interventions involving the fusion and/or stabilization of lumbar and sacral vertebra in a non-invasive manner, with minimal incision, and without the necessitating the removing the intervertebral disc. Implants for fusing both sacroiliac joints of a patient include a long implant that extends across both sacroiliac joints.

Core Innovation

The invention provides a broach for shaping a bore in bone to receive an implant. The broach includes a pyramid-shaped distal end having first, second and third pyramid-shaped pointed tips, each pointed distally, and three distal end faces that taper in a distal direction, with each distal end apex formed at a junction between adjacent distal end faces.

The broach also includes an elongate body portion extending proximally from the distal end. The elongate body portion comprises a longitudinal axis, exactly three faces, and exactly three apices formed at the junction between adjacent faces, with the three pointed tips disposed about the longitudinal axis. The distal end faces transition to the faces of the elongate body portion, and the broach is sized, configured and arranged to be withdrawn from the bone after shaping the bore.

A method aspect uses the broach to create a cavity for receiving a bone implant. The method includes inserting the broach into bone, cutting into the bone with the distal tips and forming a bore for an implant with an axially-directed non-rotational force, removing the broach, and positioning an implant within the bore.

Claims Coverage

The independent claims are clm-00001, clm-00006, and clm-00010. Across these independent claims, the inventive subject matter centers on a three-faced, three-apex broach geometry with a pyramid-shaped distal end and distally pointed tips, and on using that broach to form a bore with an axially-directed non-rotational force followed by implant positioning.

Pyramid distal end with three distally pointed tips and three tapered distal faces

A broach comprising a pyramid-shaped distal end with a terminal end that comprises first, second and third pyramid-shaped pointed tips each pointed distally, the distal end further comprising three distal end faces that taper in a distal direction, and three distal end apices each formed at a junction between adjacent distal end faces, with each pointed tip disposed at an apex of the distal end.

Three-faced, three-apex elongate body portion disposed about a longitudinal axis and withdrawal after bore shaping

The broach comprising an elongate body portion extending proximally from the distal end, the elongate body portion comprising a longitudinal axis, exactly three faces, and exactly three apices each formed at the junction between adjacent faces, with the pointed tips disposed about the longitudinal axis, and the broach sized, configured and arranged to be withdrawn from the bone after shaping the bore.

Constant radial dimension elongate body portion and tapering pyramid distal end with transition to body faces

A broach comprising a pyramid-shaped distal end and an elongate body portion extending proximally from the pyramid-shaped distal end, the elongate body portion comprising a longitudinal axis, exactly three faces and exactly three apices formed at the junctions between adjacent faces, wherein the three apices of the elongate body portion have a constant radial dimension along the elongate body portion; and the pyramid-shaped distal end comprising exactly three distal end faces that taper in a distal direction, wherein each of the three distal end faces transitions to one of the three faces of the elongate body portion.

Method of forming a bore for an implant using axially-directed non-rotational force

A method comprising inserting a broach into bone; cutting into the bone with the first, second and third plurality of tips pointed distally and forming a bore for an implant with an axially-directed non-rotational force; removing the broach from the bone; and positioning an implant within the bore.

The independent claims cover a three-tip pyramid-shaped distal end with tapered distal faces and apex junctions, a corresponding three-faced, three-apex elongate body portion disposed about a longitudinal axis and configured for withdrawal after bore shaping, and using the broach to cut a bore with an axially-directed non-rotational force followed by implant positioning.

Stated Advantages

Broach is sized, configured and arranged to be withdrawn from the bone after shaping the bore.

Creates a bore in bone for receiving an implant.

Documented Applications

Creating a cavity/bore in bone to receive a bone implant using a broach and subsequently positioning an implant within the bore.

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