Antibiotic eluding intramedullary nail apparatus

• US 5,433,718 A
• Filed: 08/20/1992
• Issued: 07/18/1995
• Est. Priority Date: 08/20/1992
• Status: Expired due to Term

• Current Assignee: Mark Brinker
• Original Assignee: Mark Brinker
• Inventors: Brinker, Mark
• Primary Examiner(s): Brown, Michael A.
• Application Number:
  US07/934,114
• Time in Patent Office: 1,062 Days
• Field of Search: 606/72, 606/73, 606/74, 606/75, 606/76, 606/77, 606/62-68
• US Class Current: 606/62
• CPC Class Codes: A61B 17/72 Intramedullary pins, nails or other devices A61B17/744 takes precedence
• CPC Class Codes: A61B 17/7283 with special cross-section of the nail
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61L 2300/406 Antibiotics
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61M 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04

Abstract

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.

Claims

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 and an exterior surface, wherein said bone stabilizing means is positionable within the medullary canal of the fractured bone;

said bone stabilizing means having a plurality of "C" shaped grooves integrally formed in the exterior surface of said bone stabilizing means extending longitudinally from said first and to said second end of said 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 plurality of c-shaped grooves to in turn be capable of being operably and releaseably positionable within at least a portion of the plurality of c-shaped 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 is 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.

14. 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 comprising a hollow shaft having an internal region defined by an interior surface, a first end, a second end and an exterior surface, wherein said bone stabilizing means is positionable within the medullary canal of the fractured bone;

said hollow shaft having a plurality of apertures depending from said internal region and extending through said interior surface and said exterior surface;

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;

and wherein said antibiotic compound is operably positioned within the internal area of the hollow shaft so as to preclude direct contact of said antibiotic compound means with the medullary canal of the fractured bone and to preclude said antibiotic compound means from becoming dislodged during insertion of said apparatus into the medullary canal, and, to in turn, enable the release of the bactericidal means through at least one of said apertures.

15. The invention according to claim 14 wherein said bone stabilizing means further includes an opening depending from said internal region and extending through said interior surface and said exterior surface and extending longitudinally from said first end to said second end of said bone stabilizing means to permit said bone stabilizing means to flex thereby facilitating its insertion into said medullary canal.

16. The invention according to claim 14 wherein said antibiotic compound means is formed of a segmented rod to permit flexing to preclude splitting or breaking of said antibiotic compound means during insertion into said medullary canal.

17. The invention according to claim 14 in which said antibiotic compound means operably positioned within the internal area of the hollow shaft is cannulated to permit passage of a guide wire toward facilitating insertion of the apparatus into the medullary canal.

18. A method of fabricating an antibiotic eluding intramedullary nail apparatus for use in the intramedullary fixation of fractured long bones, such as femurs, tibias and fibulas, humeri, ulnas and radii, 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 wherein an antibiotic agent is sustainably released directly into the medullary canal of fractured bones toward preventing and combating bacterial infestation of the bone and/or surrounding area, which could result in morbidity and mortality, said method comprising the steps of:

utilizing a bone stabilizing element having an exterior surface having a plurality of points and corresponding "v-shaped" depressions extending below and between adjacently positioned ones of the points;

combining an antibiotic agent with a carrier agent so as to form an antibiotic compound, said carrier agent being of the type which allows for release of said antibiotic agent after said antibiotic compound has substantially cured;

applying the antibiotic compound into at least one of said one or more plurality of "v-shaped" depressions, and, in turn, below corresponding ones of the points; and

allowing the antibiotic compound to substantially cure.

19. A method of fabricating an antibiotic eluding intramedullary nail apparatus for use in the intramedullary fixation of fractured long bones, such as femurs, tibias and fibulas, humeri, ulnas and radii, 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 wherein an antibiotic agent is sustainably released directly into the medullary canal of fractured bones toward preventing and combating bacterial infestation of the bone and/or surrounding area, which could result in morbidity and mortality, said method comprising the steps of:

utilizing a bone stabilizing element having an interior surface defining an internal region extending from a first end to a second end of said bone stabilizing element, and, a plurality of apertures depending from the internal region and extending through an adjacent portion of the interior and exterior surfaces;

combining an antibiotic agent with a carrier agent so as to form an antibiotic compound, said carrier agent being of the type which allows for release of said antibiotic agent after said antibiotic compound has substantially cured;

applying said antibiotic compound within the internal region adjacent at least one of the plurality of apertures; and

allowing the antibiotic compound to substantially cure.