Fracture fixation device, tools and methods

• US 8,287,541 B2
• Filed: 06/10/2009
• Issued: 10/16/2012
• Est. Priority Date: 05/18/2005
• Status: Active Grant

• Current Assignee: Arthrex Incorporated
• Original Assignee: Sonoma Orthopedic Products Incorporated (Arthrex Incorporated)
• Inventors: Nelson, Charles L., Saravia, Heber, McDaniel, Stephen R., Pham, Trung Ho, Mazur, Kai U., Gunther, Stephen B., Brown, Nathan
• Primary Examiner(s): MERENE, JAN CHRISTOP L
• Application Number:
  US12/482,406
• Publication Number:
  US 20100023010A1
• Time in Patent Office: 1,224 Days
• Field of Search: 606 62- 68, 138/119, 600139-152, 411/21
• US Class Current: 606/63
• CPC Class Codes: A61B 17/1717 for applying intramedullary nails or pins
• CPC Class Codes: A61B 17/1739 specially adapted for particular parts of the body
• CPC Class Codes: A61B 17/7208 Flexible pins, e.g. ENDER pins
• CPC Class Codes: A61B 17/7225 for bone compression
• CPC Class Codes: A61B 17/7241 the nail having separate elements through which screws pass
• CPC Class Codes: A61B 17/7266 with fingers moving radially outwardly
• CPC Class Codes: A61B 17/7291 for small bones, e.g. in the foot, ankle, hand or wrist
• CPC Class Codes: A61B 17/8872 Instruments for putting said fixation devices against or away from the bone A61B17/7074, A61B17/808 take precedence
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61B 2090/08021 of the patient or his organs

Abstract

A bone fixation device is provided with an elongate body having a longitudinal axis and having a first state in which at least a portion of the body is flexible and a second state in which the body is generally rigid, an actuatable gripper disposed at a distal location on the elongated body, a hub located on a proximal end of the elongated body, and an actuator operably connected to the gripper to deploy the gripper from a retracted configuration to an expanded configuration. Methods of repairing a fracture of a bone are also disclosed. One such method comprises inserting a bone fixation device into an intramedullary space of the bone to place at least a portion of an elongate body of the fixation device in a flexible state on one side of the fracture and at least a portion of a hub on another side of the fracture, and operating an actuator to deploy at least one gripper of the fixation device to engage an inner surface of the intramedullary space to anchor the fixation device to the bone. Various configurations are disclosed for allowing a device body to change shape as it moves from a flexible state to a rigid state.

Claims

1. A bone fixation device comprising:

a generally tubular body having a circumferential surface, an inner lumen, and a wall extending therebetween, the body being sized to fit within an intramedullary space within a bone, the body having a longitudinal axis;

at least one radially expandable gripper disposed within the body for engaging a surface of the intramedullary space;

an actuator comprising a distal actuator head, the distal actuator head comprising a ramped surface slideably disposed on an interior of the at least one radially expandable gripper, the actuator configured to outwardly actuate the at least one radially expandable gripper away from the longitudinal axis and away from the body;

a slit through the body wall extending through at least one complete revolution around the circumferential surface and axially along at least a portion of the body; and

a compression mechanism configured to apply an axial compression to the body to move the slit towards a closed position, thereby transforming the body from a generally flexible state to a generally rigid state.

2. The bone fixation device of claim 1 further comprising at least one pair of mating features formed by the slit, wherein one of the mating features is located on one side of the slit and the other mating feature is located on the opposite side of the slit.

3. The bone fixation device of claim 2 further comprising at least two pairs of mating features located within one revolution of the slit.

4. The bone fixation device of claim 2 further comprising at least five pairs of mating features located within one revolution of the slit.

5. The bone fixation device of claim 2 wherein the slit comprises a sinusoidal pattern that forms the pairs of mating features.

6. The bone fixation device of claim 2 wherein the mating features of at least one of the pairs interlock to limit axial expansion and contraction of the body, and to limit axial rotation in both directions of one part of the body relative to another.

7. The bone fixation device of claim 6 wherein the mating features comprise L-shaped protuberances extending from each side of the slit into mating L-shaped cavities in the opposite side of the slit.

8. The bone fixation device of claim 7 wherein the L-shaped protuberances on opposite sides of the slit directly interlock with each other.

9. The bone fixation device of claim 6 wherein the mating features comprise T-shaped protuberances extending from each side of the slit into mating T-shaped cavities in the opposite side of the slit.

10. The bone fixation device of claim 9 wherein the T-shaped protuberances on opposite sides of the slit directly interlock with each other.

11. The bone fixation device of claim 6 further comprising at least three pairs of interlocking features located within one revolution of the slit.

12. The bone fixation device of claim 6 further comprising at least seven pairs of interlocking features located within one revolution of the slit.

13. The bone fixation device of claim 1 wherein the slit comprises at least three revolutions.

14. The bone fixation device of claim 1 wherein the slit has a width that varies as it extends around the circumferential surface such that one portion of the body may axially compress more than another portion when the slit moves toward the closed position.

15. The bone fixation device of claim 1 further comprising at least two interdigitated slits extending along at least a portion of the body.

16. The bone fixation device of claim 1 wherein the compression mechanism is reversible, such that the axial compression can be removed thereby transforming the body from a generally rigid state to a generally flexible state.

17. The bone fixation device of claim 1 comprising at least four radially expandable grippers coupled to the body for engaging a surface of the intramedullary space.

18. The bone fixation device of claim 1 further comprising at least one screw hole extending radially at least partially through the body for receiving a bone screw to assist in securing the body within the intramedullary space.

19. A bone fixation device comprising:

a generally tubular body having a circumferential surface, an inner lumen, and a wall extending therebetween, the body being sized to fit within an intramedullary space within a bone, the body having a longitudinal axis;

at least one radially expandable gripper disposed within the body for engaging a surface of the intramedullary space;

an actuator comprising a distal actuator head, the distal actuator head comprising a ramped surface slideably disposed on an interior of the at least one radially expandable gripper, the actuator configured to outwardly actuate the at least one radially expandable gripper away from the longitudinal axis and away from the body;

a slit through the body wall extending around the circumferential surface and axially along at least a portion of the body, wherein the slit comprises at least one revolution;

at least one pair of mating features formed by the slit and located within one revolution of the slit, wherein the mating features of each of the at least three one pair interlock to limit axial expansion and contraction of the body, and to limit axial rotation in both directions of one part of the body relative to another; and

a compression mechanism configured to apply an axial compression to the body to move the slit towards a closed position, thereby transforming the body from a generally flexible state to a generally rigid state, the compression mechanism being reversible such that the axial compression can be removed, thereby transforming the body from a generally rigid state to a generally flexible state, and wherein the slit has a width that varies as it extends around the circumferential surface such that one portion of the body may axially compress more than another portion when the slit moves toward the closed position, thereby forming a curve in at least a portion of the body.

20. The bone fixation device of claim 19 further comprising at least one radially expandable gripper coupled to the body for engaging a surface of the intramedullary space.

21. A method of repairing a bone fracture comprising:

providing an elongate fixation device having a longitudinal axis and at least a portion transformable between a generally flexible state and a generally rigid state, the transformable portion having a slit extending around at least one complete revolution around its circumference;

inserting the device in the generally flexible state into an intramedullary canal of the bone across the fracture;

actuating a compression mechanism on the device to move the slit towards a closed position, thereby transforming the device portion from the generally flexible state to the generally rigid state;

extending a radially expandable gripper disposed within the elongated fixation device away from the longitudinal axis by moving an actuator along the longitudinal axis, the actuator comprising a distal actuator head with a ramped surface slideably disposed on an interior of the radially expandable gripper; and

engaging the radially expandable gripper to a surface of the intramedullary canal.

22. The method of claim 21 wherein the actuating step causes the portion transformable between the generally flexible state and the generally rigid state to change from a first shape to a second shape, the second shape enabling the device to grip at least one bone surface within the intramedullary space.

23. The method of claim 22 wherein the second shape is similar but not identical to a shape of the intramedullary space.

24. The method of claim 22 wherein the first shape is generally straight and the second shape is curved.

25. The method of claim 21 further comprising actuating a radially expanding gripper after the inserting step.

26. The method of claim 25 wherein the actuation of the compression mechanism and the actuation of the gripper are accomplished in a single step.

27. The method of claim 21 further comprising reversing the compression mechanism to transform the device portion from the generally rigid state to the generally flexible state, and removing the device from the bone.

28. The method of claim 21 wherein the transformable portion of the device comprises a plurality of pairs of mating features formed by the slit.

29. The method of claim 28 wherein the mating features of at least one of the pairs interlock to limit axial expansion and contraction of the transformable portion, and to limit axial rotation in both directions of one part of the transformable portion relative to another.