Segmented intramedullary fracture fixation devices and methods

• US 9,060,820 B2
• Filed: 09/13/2012
• Issued: 06/23/2015
• 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., Pham, Trung Ho, Hartdegen, Vernon R. Jr., Brown, Nathan D.
• Primary Examiner(s): Philogene, Pedro
• Assistant Examiner(s): SUMMITT, LYNNSY M
• Application Number:
  US13/614,523
• Publication Number:
  US 20130012942A1
• Time in Patent Office: 1,013 Days
• Field of Search: 606 62- 68, 606/309, 606/310, 606/313, 606/314, 606/320, 606/326, 606/327, 606/328
• US Class Current: 1/1
• CPC Class Codes: A61B 17/1725 for applying transverse screws or pins through intramedullary nails or pins
• 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 17/8872 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, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2090/031 torque limiting

Abstract

A segmented 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. Methods of repairing a fracture of a bone are also disclosed. One such method comprises inserting a segmented fixation device into an intramedullary space of the bone to place at least a portion of the fixation device in a flexible state on one side of the fracture, providing rigidity across the fracture, and operating an actuator to deploy at least one gripper to engage an inner surface of the intramedullary space to anchor the fixation device to the bone. Various configurations allow a segmented device body to change shape as it moves from a flexible state to a rigid state.

Claims

1. A segmented bone fixation device comprising:

an elongate body having a longitudinal axis and a flexible-to-rigid portion, the flexible-to-rigid portion comprising a plurality of segments, the flexible-to-rigid portion being flexible in a first state and being generally rigid in a second state which allows the elongate body to go between a flexible state to a rigid state;

an actuatable bone engaging mechanism disposed within the elongate body, wherein the bone engaging mechanism comprises a gripper having at least one bendable member such that as the gripper is actuated, the bendable member pivots away from the longitudinal axis of the elongate body and the gripper is deployed from a retracted configuration to an engaged configuration; and

an actuator operably connected to the bone engaging mechanism to actuate the bone engaging mechanism from a disengaged configuration to the engaged configuration, wherein the actuator is full enclosed within the elongate body, wherein the actuator comprises a first ramped surface that is slideably coupled to an interior surface of the bendable member of the gripper, wherein proximally moving the first ramped surface of the actuator causes the first ramped surface to slideably engage the interior surface of said bendable member at an angle thereby pivoting the bendable member of the gripper away from the longitudinal axis away from the elongate body to deploy the bone engaging mechanism into the engaged configuration.

2. The segmented bone fixation device of claim 1 wherein a gap between adjacent segments has a gap thickness that is disposed at least partially around the circumference of the elongate body, and wherein the elongate body changes from its flexible state to its rigid state when the gap thickness is reduced through relative motion the adjacent segments.

3. The segmented bone fixation device of claim 1, further comprising a flexible-to-rigid body sleeve configured for placement over the flexible-to-rigid body portion.

4. The segmented bone fixation device of claim 3, wherein the flexible-to-rigid body sleeve is configured to cover at least one segment, cut, edge, inter-digitation, or gap, of the flexible-to-rigid body portion.

5. The segmented bone fixation device of claim 3, wherein the flexible-to-rigid body sleeve is configured to contain at least one segment, cut, edge, inter-digitation, or gap, of the flexible-to-rigid body portion.

6. The segmented bone fixation device of claim 1 wherein the actuator is operably connected to the elongate body to change the elongate body from its flexible state to its rigid state.

7. The segmented bone fixation device of claim 1, the elongate body further comprising a drive member positioned proximally to the flexible-to-rigid portion of the elongate body and threadably engaged with the actuator.

8. The segmented bone fixation device of claim 7 wherein the actuator, having a first interface surface, is disposed at least partially within the flexible-to-rigid portion of the elongate body such that the first interface surface is distal to the flexible-to-rigid portion of the elongate body.

9. The segmented bone fixation device of claim 8, wherein by rotating the drive member, the first interface surface of the actuator and the drive member are drawn together thereby applying a compressive force to at least a portion of the elongate body along the longitudinal axis changing the elongate body from its flexible state to its rigid state.

10. The segmented bone fixation device of claim 1 wherein the elongate body changes from its flexible state to its rigid state when a compressive force is applied to at least a portion of the elongate body along the longitudinal axis.

11. A segmented 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;

a plurality of individual segments interlinked around the circumferential surface and axially along at least a portion of the body;

a compression mechanism configured to apply an axial compression to the body to move the plurality of individual segments towards a closed position, thereby transforming the body from a generally flexible state to a generally rigid state;

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

an actuator comprising a distal actuator head, wherein the distal actuator head is fully circumferentially enclosed within the tubular body, 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.

12. The bone fixation device of claim 11 further comprising at least one pair of mating features formed by the plurality of individual segments, wherein one of the mating features is located on one side of a first segment and the other mating feature is located on a corresponding side of a second segment.

13. The bone fixation device of claim 12 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.

14. The bone fixation device of claim 12 wherein the mating features comprise a T-shaped protuberance extending from the first segment into a mating T-shaped cavity in the second segment.

15. The bone fixation device of claim 11 wherein a gap between the first segment and the second segment 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 plurality of segments moves toward the closed position.

16. The bone fixation device of claim 11 further comprising a flexible-to-rigid body sleeve configured for placement over the plurality of individual segments.

17. The bone fixation device of claim 11 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.

18. 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 plurality of segments;

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 plurality of segments 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 elongate 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, wherein the distal actuator head is fully circumferentially enclosed within the radially expandable gripper; and

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

19. The method of claim 18 wherein the plurality of segments comprises a plurality of pairs of mating features interlocking the segments.

20. The method of claim 19 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.

21. The method of claim 18 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.

22. The method of claim 18 further comprising extending the radially expanding gripper after the inserting step.

23. The method of claim 22 wherein the actuation of the compression mechanism and the extending of the gripper are accomplished in a single step.

24. The method of claim 18 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.

25. The method of claim 18, further comprising containing at least a portion of the plurality of segments with a sleeve.