Total joint replacement infection control devices and methods
Inventors
de Beaubien, Brian C. • Bowman, Brian • Arnold, Benjamin • Lin, Erika • Pena, Kristen • John, Tina
Assignees
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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 agent delivery system is provided for hip arthroplasty components, comprising a femoral head configured to be disposed in an acetabulum and a femoral stem configured to be disposed in a femoral medullary canal. The femoral stem is coupled to the femoral head and includes an inlet coupled to the femoral stem, with a plurality of outlets in the femoral stem, each outlet being fluidly connected to the inlet so that a therapeutic agent introduced into the system from the inlet is deliverable from the plurality of outlets into the femoral medullary canal.
The femoral stem comprises a plurality of protrusions substantially parallel to a longitudinal axis of the femoral stem, and the plurality of outlets extend axially along a longitudinal axis of the femoral stem. The orthopedic delivery system includes intramedullary stems with internal channels and axial outlet holes in fluted regions, where the protrusions and fluted recesses are configured to minimize bone-contact area and to direct the therapeutic agent toward adjacent tissue and the medullary canal.
Coupling members are described to connect femoral stems at a controllable or selectable distance for patient anatomy, including embodiments such as an adjustable height manifold or a fixed-height wedge, with inlets configured to supply fluid to stem channels. Additional embodiments include hip configurations with a femoral head having central channels and outlet holes, including hollow or 3D-printed embodiments, and adjustable coupling via a threaded neck region with optional locking to fix head-stem distance, along with alternative internal channel configurations for separate delivery and removal paths without cross-contamination.
Claims Coverage
The document identifies two independent claims. Across these, the inventive features center on a therapeutic-agent delivery architecture for hip arthroplasty, including inlet-to-outlet fluid coupling to the femoral medullary canal and axially extending outlet structures combined with longitudinally parallel protrusions that engage bone lining the medullary canal.
Inlet-to-axially extending femoral stem outlet delivery into the medullary canal
A system including a femoral head configured to be disposed in an acetabulum, a femoral stem coupled to the femoral head and configured to be disposed in a femoral medullary canal, an inlet coupled to the femoral stem, and a plurality of outlets in the femoral stem where each outlet is fluidly connected to the inlet so that a therapeutic agent introduced from the inlet is deliverable from the plurality of outlets into the femoral medullary canal.
Longitudinally parallel femoral stem protrusions
The femoral stem comprises a plurality of protrusions that are substantially parallel to the longitudinal axis of the femoral stem, where the plurality of protrusions engage bone lining the medullary canal.
Axially extending femoral stem outlets along the longitudinal axis
The plurality of outlets extend axially along a longitudinal axis of the femoral stem, and are arranged so the therapeutic agent can be delivered into the femoral medullary canal from those axially extending outlets.
Therapeutic agent delivery method using coupled head and stem outlets
A method including positioning a femoral stem in a medullary canal of a femur, coupling a femoral head with the femoral stem wherein each outlet in the femoral stem is fluidly connected to an inlet coupled to the femoral stem, positioning the femoral head in an acetabulum, and delivering a therapeutic agent to the medullary canal.
Overall claim coverage centers on delivering a therapeutic agent from a system inlet through a fluidly connected plurality of outlets in a femoral stem into the femoral medullary canal, where the outlets extend axially and the stem includes protrusions substantially parallel to the longitudinal axis to engage bone lining the medullary canal. The method claim mirrors the system by specifying positioning and coupling steps for the femoral stem and femoral head and delivering the therapeutic agent to the medullary canal.
Stated Advantages
Minimizes bone-contact area through fluted regions and protrusions/fins.
Provides delivery of therapeutic agent into the femoral medullary canal via axially extending outlets.
Directs therapeutic agent toward adjacent tissue and the medullary canal.
Allows separate delivery and removal paths without cross-contamination.
Documented Applications
Orthopedic therapeutic-agent delivery for infected total joint replacement, including infected hip arthroplasty components with a femoral head and femoral stem disposed in an acetabulum and femoral medullary canal.
Orthopedic treatment of a joint by delivering a therapeutic agent to a medullary canal in the context of hip arthroplasty.
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