Intramedullary catheter nail apparatus and method

• US 6,387,098 B1
• Filed: 04/22/2000
• Issued: 05/14/2002
• Est. Priority Date: 10/21/1999
• Status: Expired due to Fees

• Current Assignee: Cole, Peter Alexander, Parsell, Douglas Eric
• Original Assignee: Cole, Peter Alexander, Parsell, Douglas Eric
• Inventors: Parsell, Douglas Eric, Cole, Peter Alexander
• Primary Examiner(s): Hirsch, Paul J.
• Application Number:
  US09/557,786
• Time in Patent Office: 752 Days
• Field of Search: 606/62, 606/67
• US Class Current: 606/62
• CPC Class Codes: A61B 17/72 Intramedullary pins, nails or other devices A61B17/744 takes precedence
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers

Abstract

An intramedullary catheter nail apparatus and method is disclosed that provides both the mechanical stabiliazation and therapeutic drug delivery needed to optimize long bone repair. In the preferred embodiment, the intramedullary catheter nail contains circular channels running along its length that have open communication with the outer surface of the nail, but are primarily receded within the nail. Enclosed in these channels are end-capped, catheter tubes with perforated regions mared with radiographically-visible rings. Once the nail is mechanically fixed within the repaired long bone, the catheter tubes are retracted the needed distance so as to position the perforated regions adjacent to the site of bone fracture or disease. Internal catheter tubes would preferably unite as exiting the nail. Catheter tubing would exit the patient'"'"'s body through a subcutaneous port, thus allowing convenient and sterile connection to a pumping source of therapeutic agents, such as an infusion pump. The delivery of growth factors, analgesics, chemotherapeutic, antibiotics, anti-inflammatories, diagnostic agents or mixtures of various components of differing classes directly to the trauma site would be facillitated.

Claims

1. A bone repair system comprising:

an intramedullary nail sized and shaped so as to facilitate positioning of said nail within a long bone containing a fractured region in order to strengthen said bone, said nail including a length and a surface;

at least one channel groove disposed within said intramedullary nail along at least a portion of the length of said intramedullary nail, said channel groove including an opening through the surface of said nail; and

at least one catheter tube positioned within said at least one channel groove of said intramedullary nail, said catheter tube including a first end for introduction of a medicament therethrough, a second plugged end opposite said first end, and at least one diffusion hole through a surface of said catheter tube through which a medicament may be applied to a desired bone treatment site from said catheter through said opening in said nail, said at least one diffusion hole being positioned relative to said bone treatment site by selective insertion or retraction of said catheter tube relative to said intramedullary nail, wherein said catheter tube seals said channel groove on either side of said at least one diffusion hole so that the medicament flows through said opening in said nail in an area adjacent said at least one diffusion hole rather than along said channel groove.

2. A bone repair system as defined in claim 1, wherein said catheter tube includes a perforated region that includes a plurality of diffusion holes, wherein said catheter tube seals the channel groove on either side of said perforated region so that the medicament flows through said opening in said nail in an area adjacent said perforated region rather than along said channel groove.

3. A bone repair system as defined in claim 2, wherein said perforated region is located approximately two inches from said plugged end of said catheter tube.

4. A bone repair system as defined in claim 1, wherein said catheter tube further includes a radiographically visible marking at or near the diffusion hole that permits radiographic verification of the location of the diffusion hole relative to the fracture site.

5. A bone repair system as defined in claim 4, wherein said radiographically visible marking comprises a radiographically visible ring.

6. A bone repair system as defined in claim 4, wherein said radiographically visible marking comprises a radio-opaque material that includes at least one of barium, lanthanum, strontium, or yttrium.

7. A bone repair system as defined in claim 1, wherein said intramedullary nail includes from between one to four channel grooves, each of which is sized and configured to receive one of said at least one catheter tube.

8. A bone repair system as defined in claim 1, wherein said opening in said channel groove extends through the surface of said nail along an entire length of said channel groove.

9. A bone repair system as defined in claim 1, wherein said intramedullary nail comprises at least one of a titanium alloy, a cobalt-chrome alloy, a stainless steel alloy, or a polymer composite.

10. A bone repair system as defined in claim 1, wherein said catheter tube comprises at least one of polyethylene, polyurethane, or polyimide.

11. A bone repair system comprising:

an intramedullary nail sized and shaped so as to facilitate positioning of said nail within a long bone containing a fractured region in order to strengthen said bone, said nail including a length and a surface;

at least one channel groove disposed within said intramedullary nail along at least a portion of the length of said intramedullary nail, said channel groove including an opening through the surface of said nail; and

at least one catheter tube positioned within said at least one channel groove of said intramedullary nail, said catheter tube including a first end for introduction of a medicament therethrough, a second plugged end opposite said first end, and at least one diffusion hole through a surface of said catheter tube through which a medicament may be applied to a desired bone treatment site from said catheter through said opening in said nail, said at least one diffusion hole being positioned relative to said bone treatment site by selective insertion or retraction of said catheter tube relative to said intramedullary nail, wherein said catheter tube includes at least one radiographically visible marking at or near said at least one diffusion hole.

12. A bone repair system as defined in claim 11, wherein said catheter tube includes a perforated region that includes a plurality of diffusion holes.

13. A bone repair system as defined in claim 12, wherein said radiographically visible marking is centered within the perforated region.

14. A bone repair system as defined in claim 12, wherein said catheter tube seals the channel groove on either side of said perforated region so that the medicament flows through said opening in said nail in an area adjacent said perforated region rather than along said channel groove.

15. A bone repair system, comprising:

an intramedullary nail sized and shaped so as to facilitate positioning of said nail within a long bone containing a fractured region in order to strengthen said bone, said nail including a length and a surface and at least one channel groove disposed within said intramedullary nail along at least a portion of the length of said intramedullary nail, said channel groove including an opening through the surface of said nail; and

at least one catheter tube sized and configured for positioning within said at least one channel groove of said intramedullary nail, said catheter tube including a first end for introduction of a medicament therethrough, a second plugged end opposite said first end, and at least one diffusion hole through a surface of said catheter tube through which a medicament may be applied to a desired bone treatment site from said catheter through said opening in said nail, wherein said at least one diffusion hole is positionable relative to said bone treatment site by selectively inserting or retracting said catheter tube relative to said intramedullary nail, wherein said catheter tube is sized relative to said channel groove so as to seal said channel groove on either side of said at least one diffusion hole so that, when the catheter tube is positioned within said channel groove, the medicament flows through said opening in said nail in an area adjacent said at least one diffusion hole rather than along said channel groove.

16. A bone repair system as defined in claim 15, wherein said catheter tube includes a perforated region that includes a plurality of diffusion holes, wherein said catheter tube seals the channel groove on either side of said perforated region so that the medicament flows through said opening in said nail in an area adjacent said perforated region rather than along said channel groove.

17. A bone repair system as defined in claim 16, wherein the perforated region of said catheter tube further includes a radiographically visible marking ring that permits radiographic verification of the location of the perforated region relative to the fracture site.

18. A bone repair system, comprising:

an intramedullary nail sized and shaped so as to facilitate positioning of said nail within a long bone containing a fractured region in order to strengthen said bone, said nail including a length and a surface and at least one channel groove disposed within said intramedullary nail along at least a portion of the length of said intramedullary nail, said channel groove including an opening through the surface of said nail; and

at least one catheter tube sized and configured for positioning within said at least one channel groove of said intramedullary nail, said catheter tube including a first end for introduction of a medicament therethrough, a second plugged end opposite said first end, and at least one diffusion hole through a surface of said catheter tube through which a medicament may be applied to a desired bone treatment site from said catheter through said opening in said nail, wherein said at least one diffusion hole is positionable relative to said bone treatment site by selectively inserting or retracting said catheter tube relative to said intramedullary nail, wherein said catheter tube includes at least one radiographically visible marking at or near said at least one diffusion hole.

19. A bone repair system as defined in claim 18, wherein said catheter tube includes a perforated region that includes a plurality of diffusion holes.

20. A bone repair system as defined in claim 19, wherein said catheter tube seals the channel groove on either side of said perforated region so that the medicament flows through said opening in said nail in an area adjacent said perforated region rather than along said channel groove.