Deformity correction using neural integrity monitoring

• US 9,278,214 B2
• Filed: 11/14/2011
• Issued: 03/08/2016
• Est. Priority Date: 04/30/2007
• Status: Active Grant

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: Young, John Stewart
• Primary Examiner(s): EISEMAN, ADAM JARED
• Application Number:
  US13/295,288
• Publication Number:
  US 20120059423A1
• Time in Patent Office: 1,576 Days
• Field of Search: 600/547, 606246-279
• US Class Current: 1/1
• CPC Class Codes: A61B 17/7092 for checking pedicle hole has correct depth or has an intact wall pedicle drill depth limiters A61B17/1626
• CPC Class Codes: A61B 2017/00039 Electric or electromagnetic phenomena other than conductivity, e.g. capacity, inductivity, Hall effect
• CPC Class Codes: A61B 2017/0262 with a provision for protecting nerves
• CPC Class Codes: A61B 5/05 Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves impedance plethysmography A61B5/0295; measuring movement of the entire body or parts thereof A61B5/11; detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof A61B5/24
• CPC Class Codes: A61B 5/4041 Evaluating nerves condition
• CPC Class Codes: A61B 5/4893 Nerves
• CPC Class Codes: A61N 1/3604 for correcting spinal deformities, e.g. scoliosis

Abstract

A method is provided for detecting neural interference between a bone anchor and a neural element during or subsequent to the application of force on the bone anchor to adjust the orientation of one or more vertebral bodies relative to the spinal column. The method includes engaging at least one bone anchor to the vertebral body and applying force to the bone anchor to adjust the positioning or orientation of the vertebral body. A nerve monitoring system provides an electrical signal and is operable to detect a neural element and its proximity to the bone anchor as a function of a characteristic of the electrical signal.

Claims

1. A method comprising:

engaging a bone anchor to a location on a vertebral body when the vertebral body is in a first orientation;

coupling the bone anchor with a correction tool;

manipulating the correction tool to move the vertebral body toward a second orientation with the bone anchor;

electrically monitoring the bone anchor with a nerve monitoring system that provides an electrical signal that travels through the correction tool to the bone anchor to detect interference between a neural element and the bone anchor while the vertebral body is moved toward the second orientation; and

retaining the vertebral body in the second orientation by coupling a connecting element to the bone anchor and an implant engaged to a second vertebral body, the connecting element being spaced apart from the implant while the correction tool is manipulated to move the vertebral body.

2. The method of claim 1, further comprising returning the vertebral body from the second orientation toward the first orientation upon detection of interference between the neural element and the bone anchor.

3. The method of claim 2, further comprising engaging the bone anchor in the vertebral body with the bone anchor in at least one of a differing location, differing orientation, and differing trajectory in the vertebral body after returning the vertebral body toward the first orientation.

4. The method of claim 3, wherein after engaging the bone anchor in at least one of a differing location, differing orientation, and differing trajectory, further comprising manipulating the correction tool to move the vertebral body toward the second orientation through the bone anchor while monitoring the bone anchor with the nerve monitoring system to detect interference between the neural element and the bone anchor.

5. The method of claim 1, further comprising preparing a hole in bony tissue of the vertebral body to receive the bone anchor.

6. The method of claim 5, wherein the bony tissue is located within a spinal pedicle of the vertebral body.

7. The method of claim 6, wherein the bone anchor includes a longitudinally threaded stem structured to threadingly engage bony tissue around the hole.

8. The method of claim 1, further comprising disengaging the correction tool from the bone anchor.

9. The method of claim 8, wherein coupling the connecting element to the bone anchor and the implant forms a rigid construct between one or more vertebral levels along a spinal column.

10. The method of claim 1, wherein the nerve monitoring system is operable to provide an electrical signal to the bone anchor and detect interference between the neural element and the bone anchor by measuring a neural element threshold as a function of the electrical signal.

11. The method of claim 10, wherein bone anchor is electrically coupled to the nerve monitoring system.

21. The method of claim 1, wherein retaining the vertebral body in the second orientation further comprises coupling the connecting element to a second implant engaged to a second adjacent vertebral body, the connecting element being spaced apart from the second implant while the correction tool is manipulated to move the vertebral body.

22. The method of claim 1, wherein the implant is a bone anchor.

12. A surgical method comprising:

forming a bone anchor hole at a first location into a vertebral body of a spinal column;

engaging a bone anchor to the vertebral body in the bone anchor hole;

coupling a correction tool with the bone anchor;

coupling a nerve monitoring system to the correction tool;

applying force to the bone anchor with the correction tool to change an orientation of the vertebral body relative to the spinal column while detecting for interference between a neural element and the bone anchor with the nerve monitoring system;

detecting interference between the neural element and the bone anchor with the nerve monitoring system by providing an electrical signal from the nerve monitoring system that travels through the correction tool and the bone anchor;

applying force to at least one of a second location on the vertebral body with the correction tool to move the spinal column from a first orientation to a second orientation after detecting interference between the neural element and the bone anchor; and

retaining the spinal column in the second orientation by coupling a connecting element to the bone anchor and an implant engaged to a second vertebral body, the connecting element being spaced apart from the implant while the correction tool applies force to move the spinal column to the second orientation.

13. The method of claim 12, wherein the first location on the vertebral body is a pedicle wall.

14. The method of claim 12, wherein the bone anchor is a pedicle screw.

15. The method of claim 12, wherein the nerve monitoring system detects interference between the neural element and the bone anchor by measuring a neural element threshold as a function of the electrical signal.

16. A method comprising:

preparing a bony tissue area of a vertebra for reception of a bone anchor when the vertebra is in a first position;

electrically coupling a nerve monitoring system to a bone anchor driver;

engaging the bone anchor with the bone anchor driver to engage the bone anchor to the prepared bony tissue area of the vertebra while providing an electrical signal to the bone anchor through the bone anchor driver;

detecting a neural element threshold as a function of the electrical signal with the nerve monitoring system while engaging the bone anchor to the bony tissue area;

engaging the bone anchor with a correction tool;

electrically coupling the correction tool with the nerve monitoring system;

moving the correction tool while engaged to the bone anchor to change an orientation of the vertebra to a second position from the first position;

providing an electrical signal through the correction tool to the bone anchor to detect a neural element threshold as a function of the electrical signal with the nerve monitoring system while changing the orientation of the vertebra; and

fixing the vertebra at the second position with a connecting element anchored to the bone anchor and extending to a second bone anchor engaged to a second vertebra, the connecting element being spaced apart from the second bone anchor as the correction tool moves the vertebra to the second position.

17. The method of claim 16, further comprising moving the correction tool to return the vertebra toward the first position when interference is detected between the bone anchor and the neural element.

18. The method of claim 17, further comprising adjusting a location of the bone anchor in the vertebra when interference is detected between the neural element and the bone anchor.

19. The method of claim 18, wherein after adjusting the location of the bone anchor, further comprising:

engaging the bone anchor with the correction tool;

coupling the nerve monitoring system to the correction tool; and

moving the correction tool to change the orientation of the vertebra toward the second position from the first position while detecting a neural element threshold as a function of the electrical signal with the nerve monitoring system.

20. The method of claim 16, wherein the bony tissue area of the vertebra is within a spinal pedicle.

23. A method comprising:

engaging a bone anchor to a location on a vertebral body when the vertebral body is in a first orientation;

coupling the bone anchor with a connecting element;

coupling the connecting element with a correction tool;

manipulating the correction tool to move the vertebral body toward a second orientation with the connecting element; and

electrically monitoring the bone anchor with a nerve monitoring system that provides an electrical signal that travels through the correction tool to the bone anchor to detect interference between a neural element and the bone anchor while the vertebral body is moved toward the second orientation,

wherein manipulating the correction tool comprises applying a rotational force to the correction tool which rotates the correction tool and correspondingly rotates the vertebral body toward the second orientation.

24. The method of claim 23, further comprising retaining the vertebral body in the second orientation by coupling the connecting element to the bone anchor and an implant engaged to a second vertebral body, the connecting element being spaced apart from the implant while the correction tool is manipulated to move the vertebral body.