Intramedullary interlocking fixation device for the distal radius

• US 6,527,775 B1
• Filed: 09/22/2000
• Issued: 03/04/2003
• Est. Priority Date: 09/22/2000
• Status: Expired due to Term

• Current Assignee: Wright Medical Technology Incorporated (Stryker Corporation)
• Original Assignee: Piper Medical Inc.
• Inventors: Warburton, Mark J.
• Primary Examiner(s): Manahan, Todd E.
• Application Number:
  US09/668,941
• Time in Patent Office: 893 Days
• Field of Search: 606/62, 606/63, 606/64, 606/69
• US Class Current: 606/62
• CPC Class Codes: A61B 17/164 intramedullary
• CPC Class Codes: A61B 17/1686 for the hand or wrist
• CPC Class Codes: A61B 17/1703 using imaging means, e.g. by X-rays
• CPC Class Codes: A61B 17/1717 for applying intramedullary nails or pins
• CPC Class Codes: A61B 17/1725 for applying transverse screws or pins through intramedullary nails or pins
• CPC Class Codes: A61B 17/1782 for the hand or wrist
• CPC Class Codes: A61B 17/72 Intramedullary pins, nails or other devices A61B17/744 takes precedence
• CPC Class Codes: A61B 17/7241 the nail having separate elements through which screws pass
• CPC Class Codes: A61B 17/92 Impactors or extractors, e.g. for removing intramedullary devices insertion or extraction of artificial joints A61F2/4603
• CPC Class Codes: A61B 2017/00849 with respect to tissue, e.g. hollow organs
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61F 2310/0097 Coating or prosthesis-covering structure made of pharmaceutical products, e.g. antibiotics

Abstract

Methods and devices for treating fractures in or adjacent the wrist and distal forearm employ an intramedullary interlocking fixation rod (i.e, it interlocks the distal and proximal fracture fragments together) to stabilize the skeletal structure in a manner which can inhibit the amount of collapse or loss in skeletal length exhibited by a patient with a distal radius fracture.

Claims

1. A method for treating a distal radius fracture of a patient comprising the use of an internal fixation rod, the radius anatomically having an articular joint surface, a metaphysis region, a shaft portion and a medullary canal associated therewith, the distal radius fracture having a fracture line which divides the radius into a distal fracture fragment portion and a proximal fracture fragment portion, the distal fragment portion including the distal end of the radius proximate the articular joint surface, the distal portion of the fracture having a width thereacross, said method comprising the steps of:

installing an elongated rod having opposing proximal and distal portions into the medullary canal of the patient such that the distal portion of the rod resides distal to the fracture line and the proximal portion of the rod resides proximal to the fracture line;

securing a distal fixation member to the elongated rod and into the distal end portion of the radius at a location which is distal to the fracture line such that, in position, the distal fixation member is sized and configured to extend internal to the patient across a portion of the distal fracture fragment; and

anchoring the elongated rod inside the medullary canal of the radius at a location which is below the fracture line.

2. A method according to claim 1, wherein said anchoring step includes the step of inserting, in serial order, at least one proximal fixation member into a first side of the shaft of the radius, into the elongated rod in the intramedullary canal, and then into the opposing side of the shaft of the radius.

3. A method according to claim 2, wherein the at least one proximal fixation member is two.

4. A method according to claim 2, wherein in position, said at least one proximal member laterally extends through said proximal aperture in a first direction, and wherein the distal fixation member laterally extends through said distal aperture in a second direction, the second direction being substantially perpendicular to said first direction.

5. A method according to claim 1, wherein the elongated rod includes a distal aperture that is configured to receive the distal fixation member, wherein the distal fixation member includes first and second opposing end portions, the first end portion having a head that is configured to be received a distance into the distal aperture of the rod, and wherein the securing step is carried out by inserting the distal fixation member into the aperture such that the distal fixation member resides directly against the rod and the second opposing end portion extends a distance outside the rod aperture at an angle that medially declines such that, in position, the second end portion is held at a more proximal location than the first end portion.

6. A method according to claim 1, wherein said elongated fixation rod has a curvilinear profile with an arcuate portion that corresponds to the contour of the shape of the perimeter of the radius in the metaphysis region, said curvilinear profile including a distal curve portion at said distal portion of said device, said distal curve portion adapted to accommodate the radial styloid region of the radius proximate the articular joint surface.

7. A method according to claim 1, wherein the elongated rod is configured, when viewed from an anterior-posterior direction, such that the rod substantially linearly extends along the proximal portion thereof and then transitions to take on a curvilinear profile adjacent the distal portion of the rod.

8. A method according to claim 7, wherein said upper distal end portion of the rod has an increased cross-sectional area relative to the lower proximal portion.

9. A method according to claim 1, wherein said upper distal end portion of the rod has a head which is beveled.

10. A method according to claim 1, wherein said securing the distal fixation member to the elongated rod is carried out such that the distal fixation member extends internal of the patient substantially medially across a major portion of the width of the distal fracture fragment but within the bounds of the outermost perimeter of the radius bone.

11. A method according to claim 10, wherein said distal fixation member is sized and configured so that, in position, it extends across substantially the entire width of the distal fracture fragment from the radial to ulnar regions to provide support for the central and ulnar aspect of the distal radius fragment.

12. A method according to claim 10, wherein the distal fixation member angularly extends between about 10-90 degrees away from the axial direction defined by a line drawn through the center of the proximal portion of the elongated rod.

13. A method according to claim 10, wherein the distal fixation member includes first and second opposing end portions with an intermediate threaded portion therebetween, the first end portion having a head that is configured to be received a distance into the distal aperture of the rod, the second end portion being unthreaded.

14. A method according to claim 1, further comprising the step of providing the elongated rod in an assortment of incremental sizes ranging from between about 2.5-4.5 inches long.

15. A method according to claim 1, wherein, postoperatively in position in the patient, the elongated rod and fixation members are sized and configured to be implanted within the body of the subject such that the, rod and fixation members are devoid of externally located members.

16. A method according to claim 1, wherein the distal fixation member is sized and configured with a medial extension length that is sufficient to extend across at least a major portion of the width of the distal fracture fragment in the metaphysis region of the distal radius without extending beyond the perimeter of the radius.

17. A method according to claim 1, wherein the elongated rod is a unitary body.

18. A method according to claim 1, wherein the elongated rod is configured with linkable segments.

19. A method according to claim 18, wherein the distal end portion of the elongated rod is matably attached to an intermediate portion of the rod.

20. A method according to claim 18, wherein the elongated rod includes at least three matable segments, a distal end segment, a proximal end segment, and an intermediate length adjustable segment configured to attach said distal and proximal end segments together.

21. A method according to claim 20, wherein the intermediate segment is provided in an assortment of lengths to adjust to the desired length of the rod to more appropriately fit the patient at a use or treatment point.

22. A method according to claim 21, wherein the intermediate segment is a plurality of linkable similar sized segments for adjusting the desired length of the rod to reflect the patient'"'"'s anatomical needs.

23. A method according to claim 20, further comprising the step of selecting a desired length of the intermediate segment to correspond with the anatomy of the patient and attaching the intermediate segment to the distal end and proximal end segments.

24. A method according to claim 23, wherein said selecting step is carried out substantially contemporaneous with said installing step.

25. A method according to claim 1, wherein the elongated rod includes a respective one aperture formed therein for each of said at least one proximal fixation members.

26. A method according to claim 25, wherein each proximal aperture is unthreaded and the proximal fixation members are configured to threadably attach to the radius shaft.

27. A method according to claim 25, further comprising the steps of:

attaching an external positioning guide onto a distal portion of the elongated rod such that the guide extends above the radius external of the patient'"'"'s body to visually indicate the position of the at least one proximal aperture in the rod as it resides in the medullary canal of the patient; and

removing the external positioning guide after said step of securing said at least one proximal fixation member to the rod and the radius.

28. A method according to claim 1, wherein at least a portion of said elongated rod has a cross section which is substantially rectangular.

29. An internal fixation device for treating or repairing distal radius fractures having a fracture line forming distal and proximal fracture fragments, the radius anatomically configured with a distal articular joint surface, a metaphysis region, a shaft, and a medullary canal, the distal portion of the radius having a width which extends, from a radial region to a central and ulnar region, said device comprising:

an elongated fixation rod having opposing distal and proximal portions, said distal portion including a head with a laterally extending distal aperture formed therein, said proximal portion comprising at least one proximal aperture formed therein, wherein said elongated fixation rod proximal portion is sized and configured such that, in position, it resides in the shaft inside a portion of the medullary canal of the radius of a patient;

a distal fixation member configured to enter said distal portion aperture and attach to said rod and the distal fracture fragment to hold said distal portion of said rod to the distal fracture fragment, wherein said distal fixation member has a lateral extension length and is sized and configured so that, in position, it laterally extends through said rod distal aperture beyond the perimeter of said rod and across at least a major portion of the radius in the metaphysis region; and

at least one proximal fixation member, a respective one for each of said at least one proximal apertures, said proximal fixation member configured to secure said proximal portion of said fixation rod to the radius proximal to the fracture line,

wherein, in position, said elongated fixation rod is configured and sized to reside within the radius, and wherein said distal fixation member and said at least one proximal fixation member are configured and sized as implants that reside internally in the patient.

30. A device according to claim 29, wherein said distal fixation member has opposing first and second end portions, the first end portion having a head that is configured to reside directly against said elongated fixation rod when in position in a patient, and wherein, the distal fixation member is sized and configured so that, in position, said opposing end portions of the distal fixation member reside inside the natural outer perimeter of the distal radius.

31. A device according to claim 29, wherein said proximal end portion has a smaller cross sectional area relative to a distal portion of said rod.

32. A device according to claim 31, wherein said proximal end portion is configured as a tapered region.

33. A device according to claim 29, wherein said at least one proximal fixation member is sized and configured to attach to said elongated rod at a location which is proximal to the fracture line and the metaphysis region such that, in position, said at least one proximal fixation member extends in serial order, through a portion of the radius shaft, through said proximal aperture in said rod, and then into an opposing portion of the radius shaft to thereby secure said proximal portion of said rod in position relative to the radius, wherein in position, said at least one proximal member laterally extends through said proximal aperture in a first direction, and wherein the distal fixation member laterally extends through said distal aperture in a second direction, the second direction being substantially perpendicular to said first direction.

34. A device according to claim 33, wherein each of said at least one proximal fixation members is configured to extend through said proximal aperture and threadably attach to the two portions of the radius shaft.

35. A device according to claim 29, in combination with an insertion guide configured to removably attach to said distal portion of said rod at said distal aperture, said driver configured to allow positioning of said rod into the patient.

36. A device according to claim 35, wherein said insertion guide comprises a longitudinally extending external proximal member alignment guide extending from at least said distal portion of said elongated rod to said proximal portion of said rod such that said proximal member alignment guide extends above the radius to visually indicate the position of said at least one proximal aperture in said rod as said rod resides in the medullary canal of the patient.

37. A device according to claim 29, wherein said distal fixation member is secured to said elongated rod such that, in position, said distal fixation member is sized and configured to extend across a major portion of the, but less than the entire, width of the distal fracture fragment and/or the distal radius bone proximate the articular joint surface.

38. A device according to claim 37, wherein, in position said distal fixation member is sized and configured to extend across substantially the entire width of the distal fracture fragment from the radial to ulnar regions and reside internally in the distal radial bone to provide support to the central and ulnar aspect of the distal radius fragment.

39. A device according to claim 37, wherein, in position, said distal fixation member laterally extends at least about 45 degrees away from the axial direction defined by a line drawn through the center of said proximal portion of said elongated rod.

40. A device according to claim 29, wherein at least a portion of said elongated rod has a cross section which is substantially rectangular.

41. A device according to claim 29, wherein said elongated rod is configured in an assortment of incremental sizes ranging from about 2.5-4.5 inches long and about 2.5-4 mm in width.

42. A device according to claim 29, wherein, post-operatively in position, said elongated rod and distal and proximal fixation members are configured and sized to be implanted within the body of the patient such that said device is devoid of externally located members.

43. A device according to claim 29, wherein, in position, said distal fixation member is sized and configured to extend across a major portion of the width of the distal fracture fragment in the metaphysis region of the distal radius to reside within the bounds of the natural distal radius bone thereat.

44. A device according to claim 29, wherein said elongated rod comprises a plurality of attachable segments.

45. A device according to claim 44, wherein said elongated rod is configured as a unitary body.

46. A device according to claim 44, wherein said elongated rod comprises a first distal segment providing said head portion of said rod and a second proximal segment providing said opposing proximal portion of said rod.

47. A device according to claim 46, further comprising a threaded pin configured to engage with said first and second segments to hold said first and second segments in abutting alignment.

48. A device according to claim 46, further comprising an intermediate segment with opposing upper and lower portions, wherein said upper portion is configured to matably attach to said first segment and said lower portion is configured to matably attach to said second segment.

49. A device according to claim 48, wherein said intermediate segment has a length which is selected to adjust the length of said rod.

50. A device according to claim 49, wherein said intermediate segment is a plurality of linkable similarly sized segments for providing the desired length of the rod in order to correspond to the patient'"'"'s anatomical considerations.

51. A device according to claim 29, wherein said elongated fixation rod has a curvilinear profile with an arcuate portion that corresponds to the contour of the shape of the perimeter of the radius in the metaphysis region, said curvilinear profile including a distal curve portion at said distal portion of said device, said distal curve portion adapted to accommodate the radial styloid region of the radius proximate the articular joint surface.

52. A device according to claim 29, wherein said rod bead is configured with an increased perimeter relative to said rod proximal portion, and wherein said rod distal aperture angularly declines across the width of the rod so that, in position, the lowermost portion is located adjacent the ulna aspect.

53. A device according to claim 52, wherein said distal end of said rod head is configured such that it declines across its width.

54. A device according to claim 51, wherein said head flares to take on an increased width at said upper portion relative to said lower portion.

55. A device according to claim 29, wherein the distal fixation member includes first and second opposing end portions, the first end portion having a head that is configured to reside directly against the elongated rod when in position.

56. A device according to claim 29, wherein the distal fixation member includes an intermediate threaded portion between the first and second end portions, and wherein the first end portion has a head that is configured to be received a distance into the distal aperture of the rod, the second end portion being unthreaded for a length that is greater than the threaded length of the intermediate portion.

57. A device according to claim 56, wherein said distal aperture comprises a threaded region that, in position, engages with the threaded intermediate portion of the distal fixation member.