Total joint replacement infection control devices and methods

Inventors

de Beaubien, Brian C. • Bowman, Brian • Arnold, Benjamin • Lin, Erika • Pena, Kristen • John, Tina

Assignees

Osteal Therapeutics Inc

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Publication Number

US-12257154-B2

Patent

Publication Date

2025-03-25

Expiration Date


Abstract

An orthopedic system for delivery of a therapeutic agent to a bone includes an elongate stem adapted to be inserted into an intramedullary canal, an inlet configured to receive the therapeutic agent, and one or more outlets configured to deliver the therapeutic agent to the bone. The elongate stem may comprise one or more protrusions to engage the bone, and one or more channels extending longitudinally therein, fluidly coupled to the inlet. The therapeutic agent flows from the inlet through the one or more channels and exits into the intramedullary canal through the one or more outlets. The system may be configured to allow one or more dimensions of the system to be adjusted to accommodate the anatomy of a patient.

Core Innovation

A therapeutic fluid delivery system is provided for delivering therapeutic fluid in association with a patient having a total joint replacement. The system includes a femoral head with a surface configured to be disposed in an acetabulum, a first threaded portion, and a first plurality of outlets in the surface, coupled to a femoral stem so that therapeutic fluid introduced through an inlet exits through both outlet pluralities.

The femoral stem includes a proximal portion comprising a second threaded portion and a distal portion configured to be disposed in a femoral medullary canal of the patient. The femoral stem further includes an inlet and a second plurality of outlets in the distal portion, with each outlet of the second plurality fluidically coupled to the inlet, and the second threaded portion adjustably threadably engages the first threaded portion of the femoral head to permit adjustment of a distance between the femoral head and the distal portion of the femoral stem.

The femoral head and femoral stem are releasably locked together to maintain the distance in an assembled system, including by one or more set screws. Therapeutic fluid introduced into the assembled system through the inlet exits both the second plurality of outlets into the femoral medullary canal and the first plurality of outlets into the acetabulum, and the therapeutic fluid comprises at least one of vancomycin, tobramycin, or a combination thereof.

In further refinements, internal channel structures are defined, including a femoral head having an internal first channel connected to outlets and a femoral stem having an internal second channel connected to outlets, wherein the channels are fluidically coupled in the assembled system. Additional structural features include protrusions and fluted regions configured to contact an inner surface of the femoral medullary canal, with implantation described where 50% or less of the distal portion’s surface area contacts bone.

Claims Coverage

Two independent claims are identified. Each independent claim centers on a therapeutic fluid delivery system with an adjustable threaded coupling between a femoral head and femoral stem, releasable locking to maintain a set distance, and outlet pluralities configured to deliver therapeutic fluid to both the femoral medullary canal and the acetabulum; the second independent claim further limits the therapeutic fluid to specific antibiotic options.

Threaded adjustable coupling between femoral head and femoral stem with releasable locking

The second threaded portion of the proximal portion of the femoral stem adjustably threadably engages the first threaded portion of the femoral head to couple the femoral head to the femoral stem and permit adjustment of a distance between the femoral head and the distal portion of the femoral stem, and one or more set screws releasably lock the femoral head and the femoral stem together to maintain the distance in an assembled system.

Dual outlet therapeutic fluid delivery to femoral medullary canal and acetabulum

When a therapeutic fluid is introduced into the assembled system through the inlet, the therapeutic fluid exits both the second plurality of outlets and the first plurality of outlets, with the second plurality of outlets into the femoral medullary canal and the first plurality of outlets into the acetabulum.

Therapeutic fluid includes vancomycin and/or tobramycin

The therapeutic fluid comprises at least one of vancomycin, tobramycin, or a combination thereof.

Fluidically coupled internal channels in assembled system

A femoral head internal first channel connected to a first plurality of outlets and a femoral stem internal second channel connected to a second plurality of outlets, wherein the first channel is fluidically coupled to the second channel in the assembled system.

Releasably locked adjustable assembled system for head-to-stem distance

The femoral head and femoral stem are configured to be releasably locked together to maintain the distance in order to form an assembled system.

Across the two independent claims, the core coverage is an assembled therapeutic fluid delivery system formed by an adjustably threadably engaged femoral head and femoral stem, releasably locked to maintain distance, where therapeutic fluid exits through outlet pluralities on both the femoral head and femoral stem into the acetabulum and femoral medullary canal; the second independent claim further limits the therapeutic fluid to vancomycin and/or tobramycin.

Stated Advantages

Not explicitly described in patent.

Documented Applications

Not explicitly described in patent.

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