Intramedullary interlocking fixation devices for the distal radius

• US 8,092,453 B2
• Filed: 05/02/2006
• Issued: 01/10/2012
• Est. Priority Date: 09/22/2000
• Status: Expired due to Fees

• Current Assignee: Wright Medical Technology Incorporated (Stryker Corporation)
• Original Assignee: Piper Medical Inc.
• Inventors: Warburton, Mark J.
• Primary Examiner(s): Ramana, Anu
• Application Number:
  US11/381,227
• Publication Number:
  US 20060200143A1
• Time in Patent Office: 2,079 Days
• Field of Search: 606/53, 606/60, 606 62- 68
• US Class Current: 606/64
• 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

Medical kits 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. An intramedullary rod in combination with a cooperating insertion guide for fixation of a distal radius fracture of a patient, comprising:

a distal radius intramedullary rod having opposing distal and proximal ends and a curvilinear shape that is substantially similar to a curvature of an intramedullary canal of a human distal radius, wherein the distal end of the rod has a head with at least one laterally extending distal aperture, wherein the head, in an implanted position, is sized and configured to reside entirely within a radial styloid region of the distal radius proximate an articulating surface of the distal radius to affix distal radius fragments associated with the distal radius fracture, and wherein, in the implanted position, the rod is configured and sized to reside entirely within the radius and support and buttress the articular surface of the distal radius and allow wrist mobility while stabilizing the distal radius fracture; and

an insertion guide with a curved rod driver releasably attachable to the head of the intramedullary rod, the insertion guide sized and configured to guide the rod into position in a medullary canal, and wherein the insertion guide is sized and configured to enter a lateral entry bone window in at least one distal fracture fragment.

2. The combination of claim 1, further comprising external drill guides extending longitudinally above the insertion guide to reside outside the patient'"'"'s body when the rod is disposed therein and still attached to the insertion guide, wherein the external drill guides provide visual indicia of alignment corresponding to the location of proximal fixation member apertures in the intramedullary rod in the radius.

3. The combination of claim 1, further comprising a broach-like device with a leading reaming portion configured to enter the lateral entry bone window and extend in a longitudinal direction to follow a contour of the medullary canal to determine a size and length suitable for the rod and bore or ream an insertion passageway for insertion of the rod prior to insertion of the rod.

4. The combination of claim 1, further comprising a distal fixation member that is sized and configured to extend through the laterally extending aperture in the head of the rod and across substantially an entire width of a distal fracture fragment from radial to ulnar regions to provide support to central and ulnar aspects of the distal radius fragment.

5. The combination of claim 4, further comprising at least one proximal member that, in position, laterally extends through an aperture in a proximal portion of the rod in a first transverse direction, and wherein the distal fixation member extends through said laterally extending aperture in a second transverse direction that is offset from the first transverse direction.

6. The combination of claim 4, wherein the distal fixation member includes first and second opposing end portions, the first end portion having a head, wherein the rod has a recess that receives the head so that, in position, the head is substantially flush with an outer surface of the rod.

7. An intramedullary rod in combination with a cooperating insertion guide for fixation of a distal radius fracture of a patient, comprising:

a distal radius intramedullary rod having opposing distal and proximal ends and a curvilinear shape that is substantially similar to a curvature of an intramedullary canal of a human distal radius, wherein the distal end of the rod has a head with at least one laterally extending distal aperture, wherein the rod, in an implanted position, is sized and configured to reside entirely in the radius with the head totally within a radial styloid region proximate an articulating surface of the distal radius to affix distal radius fragments associated with the distal radius fracture and is configured and sized to support and buttress the articular surface of the distal radius and allow wrist mobility while stabilizing the distal radius fracture;

an insertion guide with a curved rod driver releasably attachable to the head of the intramedullary rod, the insertion guide sized and configured to guide the rod into position in a medullary canal, and wherein the insertion guide is sized and configured to enter a lateral entry bone window in at least one distal fracture fragment, wherein the insertion guide is attached to the rod via an attachment member inserted into the laterally extending distal aperture; and

an implantable distal fixation member that engages the distal aperture of the head after the insertion guide is released from the rod.

8. The combination of claim 7, wherein the attachment member is threaded, and wherein the insertion guide comprises an aperture that aligns with the distal aperture of the rod with the attachment member that is threaded extending through both the rod and guide apertures.

9. The combination of claim 7, wherein the laterally extending rod distal aperture angles down in a direction away from the bone window.

10. The combination of claim 7, wherein, in the implanted position, the distal fixation member extends through the laterally extending distal aperture of the head and beyond the perimeter of the rod to reside across at least a major portion of the radius in a metaphyseal region so that and the distal fixation member is configured and sized to reside within the radius of the patient, and wherein the rod and the distal fixation member are configured to hold the fracture fragments together while buttressing the distal radius articular region without an external fixation member.

11. The combination of claim 7, wherein the insertion guide has opposing proximal and distal end portions, with a handle extending from the distal end portion and an alignment member that longitudinally extends in direction away from the handle above the guide outside the patient'"'"'s body to reside above the proximal end portion of the rod, and wherein the alignment member is substantially rigid with proximal apertures configured to define the location of proximal apertures extending through the rod inside the patient'"'"'s body.

12. An intramedullary rod in combination with a cooperating insertion guide for fixation of a distal radius fracture of a patient, comprising:

a distal radius intramedullary rod having opposing distal and proximal ends and a curvilinear shape that is substantially similar to a curvature of an intramedullary canal of a human distal radius, wherein the distal end of the rod has a head with at least one laterally extending distal aperture, wherein an implanted position, is sized and configured to reside in a distal radius fracture fragment within a radial styloid region of the distal radius proximate an articulating surface of the distal radius to affix distal radius fragments associated with the distal radius fracture, and wherein, in the implanted position, the rod is configured and sized to support and buttress the articular surface of the distal radius and allow wrist mobility while stabilizing the distal radius fracture; and

an insertion guide with a curved rod driver releasably attachable to the head of the intramedullary rod, the insertion guide sized and configured to guide the rod into position in a medullary canal, and wherein the insertion guide is sized and configured to enter a lateral entry bone window in at least one distal fracture fragment,

wherein the rod has a plurality of proximal apertures that extend through the rod in a transverse direction, the transverse direction of each proximal aperture being offset from a transverse direction of the distal aperture.

13. The combination of claim 12, further comprising:

a distal fixation member configured to extend through the distal laterally extending aperture of the rod; and

a plurality of proximal fixation members, respective ones of which extend through a respective proximal aperture in the rod, whereby the rod and the at least one distal fixation member are is configured and sized to stabilize the distal radius fracture and allow wrist mobility.

14. The combination of claim 13, wherein, in position, the rod head and the distal fixation member are configured and sized to reside entirely within the radius of the patient and wherein the combination is devoid of an external fixation member.

15. The combination of claim 14, wherein the rod has a distal end that is tapered across a width thereof, and wherein the distal fixation member has a head that is recessed into the rod and has a length that is sized and configured to extend through the laterally extending distal aperture of the rod and over at least a major portion of the radius in a metaphyeal region.

16. The combination of claim 14, wherein the entire distal radius rod and the distal fixation member are sized and configured to repair the distal radius fracture without an external fixation member, and wherein the curvature of the device is substantially concave in a direction corresponding to a radial aspect of the distal radius.

17. An intramedullary rod for fixation of a distal radius fracture of a patient in combination with an insertion guide, the combination comprising:

a distal radius intramedullary rod having an elongate curvilinear shape with opposing distal and proximal ends, wherein, in an implanted position, the rod resides entirely within the radius with the distal end sized and configured to reside totally inside a radial styloid region of the distal radius proximate an articulating surface of the distal radius, wherein the rod distal end has a head that includes a laterally extending aperture, wherein, in the implanted position, the rod is configured and sized to support and buttress the articular surface of the distal radius and allow wrist mobility while stabilizing the distal radius fracture; and

an insertion guide releasably attachable to the intramedullary rod laterally extending aperture in the head, the insertion guide sized and configured to guide the rod into position in a medullary canal, and wherein the insertion guide is sized and configured to enter a lateral entry bone window in the distal radius.

18. The combination of claim 17, wherein the rod curvilinear shape is substantially similar to a curvature of an intramedullary canal of a human distal radius with the distal end tapering laterally downward toward an ulna aspect in a direction away from the radial styloid region.

19. The combination of claim 17, further comprising:

a distal fixation member that, when in an implanted position, extends through the laterally extending distal aperture of the head and beyond a perimeter of the rod to reside across a major portion of the radius in a metaphyseal region so that the distal fixation member is configured and sized to reside within the radius of the patient, and wherein the rod and the distal fixation member are configured to hold distal radius fracture fragments together while buttressing the distal radius articular region without an external fixation member; and

at least one proximal member that, in position, laterally extends through an aperture in a proximal portion of the rod in a first transverse direction, and wherein the at least one distal fixation member extends through the laterally extending distal aperture in a second transverse direction that is offset from the first transverse direction.

20. The combination of claim 19, wherein the distal fixation member includes first and second opposing end portions, the first end portion having a head, wherein the rod has a recess that receives the head so that, in position, the head is substantially flush with an outer surface of the rod.

21. The combination of claim 17, wherein a distal end of the rod is sized and configured to affix distal radius fragments associated with the distal radius fracture.