Intramedullary nail and method of use

• US 6,019,761 A
• Filed: 12/23/1998
• Issued: 02/01/2000
• Est. Priority Date: 12/23/1998
• Status: Expired due to Fees

• Current Assignee: Ramon B. Gustilo
• Original Assignee: Ramon B. Gustilo
• Inventors: Gustilo, Ramon B.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): REIP, DAVID OWEN
• Application Number:
  US09/219,668
• Time in Patent Office: 405 Days
• Field of Search: 606/62, 606/63, 606/64, 606/60, 606/96, 606/97, 606/98, 606/86, 606/72, 606/73
• 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 17/744 the longitudinal elements coupled to an intramedullary nail

Abstract

The present invention is an intramedullary nail (IM nail) device suitable for implanting within a medullary canal of a fractured long bone and subsequently interlocking the IM nail at least once to the cortical bone of the long bone. The IM nail includes a hollow center and at least a proximal opening into the hollow center and an optional distal tip opening. The IM nail is initially manufactured without any holes, channels, or the like, for the alignment and passage of screws or similar devices suitable for interlocking the IM nail with the long bone. The IM nail includes a material suitably adapted for providing post implanting drilling there through and interlocking with the long bone using these post implantation holes. The present invention makes use of removable and expandable first and optional second sealing plugs in operable sealing contact within the hollow center. The present invention also includes a cylindrical sleeve having a hollow bore open at both ends on a longitudinal axis. The cylindrical sleeve is suitable for receiving a drill bit through the hollow bore to act as a drill bit guide. The cylindrical sleeve also includes a resilient gasket at one end suitable for operable sealing engagement with the intramedullary nail outer surface.

Claims

1. A method for interlocking an intramedullary nail implantable within a medullary canal of a patient'"'"'s long bone, the method comprising the steps of:

a) providing an intramedullary nail having an outer wall surface and a longitudinal axis;

b) surgically implanting the intramedullary nail into the medullary canal of the long bone;

c) drilling a first hole through a near wall of the cortical bone using a first drill in a plane substantially transverse to the longitudinal axis and at a selectable longitudinal axial level;

d) providing a cylindrical sleeve having a hollow bore;

e) inserting the cylindrical sleeve into the first hole positioning cylindrical sleeve in operable sealing contact with the outer surface of the near wall of the intramedullary nail;

f) using a second drill, passing through the hollow bore of the cylindrical sleeve, and drilling a second hole through the intramedullary nail and far wall of the cortical bone along the axis of the first hole;

g) irrigating the cylindrical sleeve and second hole with a liquid;

h) suctioning the liquid from the cylindrical sleeve and second hole;

i) removing the cylindrical sleeve;

j) providing an interlocking wire; and

k) interlocking the intramedullary nail to the long bone by passing the interlocking wire through the first, second and third holes, tensioning the interlocking wire, and securing the interlocking wire under tension at the outer surfaces of the near and far walls of the cortical bone.

2. The method of claim 1 further comprising the steps of:

l) repeating steps (c) through (k); and

m) repeating (m) for a selectable number of iterations.

3. The method of claim 1 in which the intramedullary nail is hollow.

4. The method of claim 3 further comprising the steps of:

e1) providing a removable first sealing plug positionable within the hollow center;

e2) positioning the first sealing plug within the hollow center proximate the distal tip of the nail in operable engagement with the inner wall of the nail;

h1) suctioning and irrigating the hollow center of the intramedullary nail proximally to the first sealing plug; and

i1) removing the first sealing plug.

5. The method of claim 4 further comprising the steps of:

l) re-positioning the first sealing plug into the hollow center with the first sealing plug adjacent and proximal to the last placed interlocking wire;

m) repeating steps (c) through (k); and

n) repeating (l) and (m) for a selectable number of iterations.

6. The method of claim 3 further comprising the step of providing a removable and expandable second sealing plug in operable sealing contact within the hollow center, positionable to a selectable longitudinal axial second position.

7. The method of claim 1 in which the cylindrical sleeve has a resilient gasket at one end of the sleeve hole and positioning the resilient gasket in operable sealing contact with the outer surface of the near wall of the intramedullary nail.

8. The method of claim 1 in which the intramedullary nail is substantially solid.

9. An intramedullary nail device for implanting within a medullary canal of a long bone of a human, the intramedullary nail device comprising:

a non-fenestrated, non-drilled intramedullary nail elongated along a longitudinal axis and having a hollow center and a proximal opening into the hollow center, the intramedullary nail suitable for providing post implanting drilling there through; and

a removable first sealing plug positionable in operable sealing contact within the hollow center to a selectable longitudinal axial first position.

10. The device of claim 9 further comprising:

a cylindrical sleeve having a hollow bore open at both ends on a longitudinal axis, for receiving a drill through the hollow bore, and having a resilient gasket at one end for sealing engagement with the intramedullary nail outer surface, the cylindrical sleeve longitudinal axis in a substantially transverse orientation to the intramedullary nail longitudinal axis;

at least two removable resilient stoppers suitable for placement in at least two holes drillable into the intramedullary nail wall, operably sealing the at least two holes; and

interlocking means, passing through the at least two holes drilled into the intramedullary nail, for interlocking the intramedullary nail to the long bone cortex.

11. The device of claim 10 in which the interlocking means includes:

a wire having first stopper means, at a wire first end, for stopping the wire against the long bone cortical surface, and second stopper means, placeable over the wire from a wire second end, for stopping the wire against the long bone cortical surface at a position opposite the first stopper means.

12. The device of claim 11 in which the first stopper means includes a metal bead affixed to the wire.

13. The device of claim 12 in which the first stopper means comprises affixing the metal bead from a selection consisting of:

brazing, welding, soldering, or crimping.

14. The device of claim 11 in which the first stopper means includes a metal head formed in the wire toward the first end.

15. The device of claim 11 in which the first stopper means includes a threaded length of the wire at the first end and a nut for threading onto the wire at the first end and operably engaging the long bone cortical surface.

16. The device of claim 15 in which the first stopper means includes a washer for placement over the first end of the wire operably positionable between the nut and the long bone cortical surface.

17. The device of claim 11 in which the second stopper means includes a metal bead for sliding over the wire at the second end and operably crimping to the wire and snugly against the long bone cortical surface.

18. The device of claim 11 in which the second stopper means includes a threaded length of the wire at the second end and a nut for threading onto the wire at the second end for operable engagement of the long bone cortical surface.

19. The device of claim 18 in which the second stopper means includes a washer for placement over the second end of the wire operably positionable between the nut and the long bone cortical surface.

20. A method for interlocking an intramedullary nail implantable within a medullary canal of a patient'"'"'s long bone, the method comprising the steps of:

a) providing an intramedullary nail having at least a distal portion as a solid core and an outer wall surface and a longitudinal axis;

b) surgically implanting the intramedullary nail into the medullary canal of the long bone;

c) drilling a first hole through a near wall of the cortical bone using a first drill in a plane substantially transverse to the longitudinal axis and at a longitudinal axial level proximate the solid core;

d) providing a cylindrical sleeve having a hollow;

e) inserting the cylindrical sleeve into the first hole to position the resilient gasket in operable sealing contact with the outer surface of the near wall of the intramedullary nail;

f) using a second drill, passing through the cylindrical sleeve, and drilling a second hole through the intramedullary nail and a far wall of the cortical bone opposite the first hole;

g) irrigating the cylindrical sleeve and second hole with a liquid;

h) suctioning the liquid from the cylindrical sleeve and second hole;

i) removing the cylindrical;

j) providing an interlocking wire; and

k) interlocking the intramedullary nail to the long bone by passing the interlocking wire through the first and second holes, tensioning the interlocking wire, and securing the interlocking wire under tension at the outer surfaces of the near and far walls of the cortical bone.

21. The method of claim 20 further comprising the step of:

1) repeating steps (c) through (k).

22. The method of claim 21 further comprising the step of:

m) repeating step (l) for a selectable number of iterations.

23. The method of claim 20 in which the cylindrical sleeve has bore and a resilient gasket at one end of the sleeve for operable sealing contact with the outer surface of the intramedullary nail.

24. An intramedullary nail device for implanting within a medullary canal of a long bone of a human, the intramedullary nail device comprising:

a non-fenestrated intramedullary nail, elongated along a longitudinal axis, the intramedullary nail including at least a portion of the distal segment as a solid core adapted for providing post implanting drilling there through of at least two holes; and

a cylindrical sleeve having a hollow bore open at both ends on a longitudinal axis, for receiving a drill through the hollow bore, the cylindrical sleeve longitudinal axis operably lying in a substantially transverse orientation to the intramedullary nail longitudinal axis.

25. The intramedullary nail device of claim 24 in which the cylindrical sleeve has a resilient gasket at one end for operable sealing engagement with the intramedullary nail outer surface.

26. The device of claim 25 further comprising:

interlocking means, passing through the at least two holes drilled into the intramedullary nail, for interlocking the intramedullary nail to the long bone cortex.

27. The device of claim 26 in which the interlocking means includes:

a wire having first stopper means, at a wire first end, for stopping the wire against the long bone cortical surface, and second stopper means, placeable over the wire from a wire second end, for stopping the wire against the long bone cortical surface at a position opposite the first stopper means.

28. The device of claim 27 in which the first stopper means includes a metal bead affixed to the wire.

29. The device of claim 28 in which the first stopper means comprises affixing the metal bead from a selection consisting of:

brazing, welding, soldering, or crimping.

30. The device of claim 27 in which the first stopper means includes a metal head formed in the wire toward the first end.

31. The device of claim 27 in which the first stopper means includes a threaded length of the wire at the first end and a nut for threading onto the wire at the first end and operably engaging the long bone cortical surface.

32. The device of claim 31 in which the first stopper means includes a washer for placement over the first end of the wire operably positionable between the nut and the long bone cortical surface.

33. The device of claim 27 in which the second stopper means includes a metal bead for sliding over the wire at the second end and operably crimping to the wire and snugly against the long bone cortical surface.

34. The device of claim 27 in which the second stopper means includes a threaded length of the wire at the second end and a nut for threading onto the wire at the second end for operable engagement of the long bone cortical surface.

35. The device of claim 34 in which the second stopper means includes a washer for placement over the second end of the wire operably positionable between the nut and the long bone cortical surface.