Antibiotic eluding intramedullary nail apparatus

5,618,286

08/425,609

April 20, 1995

An antibiotic eluding intramedullary nail apparatus for use in the intramedullary fixation of fractured long bones, such as femurs, tibias, fibulas, humeri, ulnas and radii, as well as other orthopedic and bone reconstructive procedures, and, in particular fractures associated with an open wound exposing the soft tissue and medullary canal of the fractured bone to bacteria and other infectious micro-organisms. The apparatus includes an intramedullary nail to which is secured an antibiotic impregnated carrier compound, the apparatus being surgically insertable within the medullary canal of a fractured bone using conventional intramedullary nailing techniques thus providing a sustained localized release of antibiotic agents in bactericidial concentrations, and/or chemotherapeutic agents for bone tumors, directly within the medullary canal of the fractured bone and thereby serving to permit the use of intramedullary nailing to repair injuries which may be otherwise contraindicated due to the risk of deep wound and/or bone infections and/or bone tumors.

Brinker, Mark (Houston, TX)

What is claimed is

1. An antibiotic eluding intramedullary nail apparatus for use in association with the intramedullary fixation of fractured long bones, such as fractured femurs, tibias, fibulas, humeri, ulnas and radii having a medullary canal, wherein the fracture may be associated with an open wound, which in turn, may expose the medullary canal within the fractured bone, as well as the area surrounding the open wound, to bacteria and/or other infectious micro-organisms which could result in morbidity as well as mortality, said antibiotic eluding intramedullary nail apparatus comprising

means for stabilizing the fractured bone in an aligned position;

said bone stabilizing means having a first end, a second end, a longitudinal axis extending therebetween, and an exterior surface, wherein said bone stabilizing means is positionable within the medullary canal of the fractured bone;

said bone stabilizing means having one or more "C" shaped grooves integrally formed in the exterior surface of said bone stabilizing means extending longitudinally from said first end to said second end of said bone stabilizing means and displaced from said longitudinal axis of said bone stabilizing means

each such "C" shaped groove having an opening upon the exterior surface of the bone stabilizing means which has a width which is less than a greatest diameter of the respective groove

each such "C" shaped groove further having a depth which is less than the distance from the opening to the center of the bone stabilizing means;

antibiotic compound means, said antibiotic compound means including bactericidal means for inhibiting the growth of and destroying bacteria which may result in an infection in the medullary canal of the fractured bone as well as proximate the open wound associated with the fracture, and carrier means for sustainably releasing said bactericidal means;

said antibiotic compound means dimensioned so as to be effectively retained within said one or more grooves to in turn be capable of being operably and releaseably positionable within at least a portion of the one or more grooves to facilitate removal and/or replacement of said antibiotic compound, so as to permit said bactericidal means to be eluded directly into the medullary canal upon insertion and alignment of said apparatus within said canal.

2. The invention according to claim 1 wherein said antibiotic compound is formed into a plurality of generally spherical shaped beads strung together using surgical grade wire.

3. The invention according to claim 1 wherein said antibiotic compound is formed into a plurality of generally spherical shaped beads strung together using surgical grade suture.

4. The invention according to claim 1 in which said carrier means comprises bone cement.

5. The invention according to claim 4 in which said bactericidal means is combined with the bone cement by uniformly saturating said bactericidal means within the bone cement.

6. The invention according to claim 4 in which the bone cement is selected from the group consisting of cement compounds which facilitate exudation of antibiotics wherein said antibiotics can be combined with the bone cement prior to substantial curing of the bone cement.

7. The invention according to claim 1 in which said bactericidal means is selected from the group of antibiotics consisting of gentamicin, tobramycin, erythromycin, vancomicyn, oxacillin, cloxacillin, methicillin, lincomycin, ampicillin and colistin.

8. The invention according to claim 1 in which said carrier means further includes an ingredient to render same radio opaque.

9. The invention according to claim 8 wherein said ingredient barium sulfate.

10. The invention according to claim 1 in which said bone stabilizing means comprises an intramedullary nail.

11. The invention according to claim 1 in which said bone stabilizing means is cannulated to permit passage of a guide wire toward facilitating insertion of the apparatus into the medullary canal.

12. The invention according to claim 1 in which said bone stabilizing means is malleable to permit flexing toward facilitating insertion of the apparatus into the medullary canal.

13. The invention according to claim 1 wherein said antibiotic compound means further includes a chemotherapeutic agent.

606/60; 606/62

A61B 1756

4495664 January 1985 Blanquaert
4550723 November 1985 Belykh
4851008 July 1989 Johnson
4863444 September 1989 Blomer
4919666 April 1990 Buchhorn
5053035 October 1991 McLaren

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