Total joint replacement infection control devices and methods

Inventors

de Beaubien, Brian C.Bowman, BrianArnold, BenjaminLin, ErikaPena, KristenJohn, Tina

Assignees

Osteal Therapeutics Inc

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Publication Number

US-11504242-B2

Patent

Publication Date

2022-11-22

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

The invention relates to orthopedic therapeutic-agent delivery systems for treating infected tissue after total joint replacement. A first intramedullary stem is configured to be disposed in a first medullary canal of a first bone and includes a longitudinal channel and one or more outlet holes. A second intramedullary stem is configured to be disposed in a second medullary canal of a second bone and also includes a channel and outlet holes.

The first intramedullary stem includes fins extending along an elongate body, where each fin has an outermost surface configured to engage the first medullary canal. Fluted regions are radially recessed relative to the outermost surface of each fin and form smoothly concave regions laterally bounded by outermost surfaces of adjacent fins. Outlet holes are disposed in the fluted regions and are in fluid communication with the first channel, with analogous outlet-hole structures described for the second stem.

The two intramedullary stems are coupled together by at least one coupler adapted to hold the stems at a distance apart while placing a coupler inlet in fluid communication with at least one of the channels. The coupler includes an adjustable height manifold configured to increase or decrease the distance between proximal portions of the stems when actuated, or alternatively includes a wedge element whose disposition between the proximal portions adjusts the distance.

Claims Coverage

The partial content contains multiple independent claims, each focused on a treating system or therapeutic-agent delivery system for infected tissue using two intramedullary stems placed in separate medullary canals and coupled by a fluid-coupled coupler that fixes and adjusts inter-stem spacing. Across the independent claims, the coverage centers on stem/channel/outlet-hole geometry, fin/fluted engagement geometry for canal contact, and a coupler inlet that places the coupler in fluid communication with the stem channels, with spacing adjustment via either an adjustable height manifold or a wedge element.

Finned intramedullary stem with radially recessed fluted regions and channel outlet holes

A first intramedullary stem includes an elongate body with a channel extending from a proximal portion toward a distal end, a plurality of fins extending along the elongate body with outermost surfaces configured to engage the first medullary canal, and a plurality of fluted regions that are radially recessed relative to the outermost surface of each fin, where each fluted region forms a smoothly concave region laterally bounded between outermost surfaces of adjacent fins. One or more outlet holes are disposed in each fluted region, with the outlet holes in fluid communication with the first channel.

Coupler inlet in fluid communication with stem channels while holding stems at fixed spacing

At least one coupler is adapted to couple to the first proximal portion of the first intramedullary stem and to the second proximal portion of the second intramedullary stem, where the coupler holds the first and second intramedullary stems together at a distance apart. The coupler comprises a coupler inlet such that when coupled, the coupler inlet is placed in fluid communication with at least one of the first channel in the first intramedullary stem and the second channel in the second intramedullary stem.

Adjustable height manifold to increase or decrease distance between stem proximal portions

The coupler comprises an adjustable height manifold configured to increase or decrease the distance between the first proximal portion of the first intramedullary stem and the second proximal portion of the second intramedullary stem when the adjustable height manifold is actuated.

Wedge element to adjust distance between proximal portions of coupled intramedullary stems

The coupler comprises a wedge element, where disposition of the wedge element between the first proximal portion of the first intramedullary stem and the second proximal portion of the second intramedullary stem adjusts the distance between the first and second intramedullary stems.

Therapeutic-agent delivery system with radially outward protrusions forming fluted regions and outlet holes in fluid communication with a channel

A system includes first and second intramedullary stems each with an elongate body and a channel extending between ends, and a plurality of protrusions extending radially outward that define one or more fluted regions therebetween. The protrusions are configured to engage the medullary canal in a stable fashion, and one or more outlet holes are disposed in the fluted regions with the outlet holes in fluid communication with the channel.

Taken together, the independent claims provide a treating system or therapeutic-agent delivery system for infected tissue that uses two intramedullary stems in separate medullary canals, each having a channel and outlet holes, and a coupler with a coupler inlet placed in fluid communication with at least one stem channel. The inter-stem spacing is held at a distance apart and is adjusted by either an adjustable height manifold actuated to change distance between proximal portions or by a wedge element whose disposition adjusts that distance.

Stated Advantages

Not explicitly described in patent.

Documented Applications

Orthopedic therapeutic-agent delivery systems for controlling infection after total joint replacement.

Treating infected tissue using intramedullary stems disposed in medullary canals of bones, with coupler inlet fluid communication to deliver therapeutic agent and manage infection.

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