Device and method for operating a tool relative to bone tissue and detecting neural elements

• US 8,092,455 B2
• Filed: 02/07/2005
• Issued: 01/10/2012
• Est. Priority Date: 02/07/2005
• Status: Active Grant

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: Neubardt, Seth L., Adcox, William Keith, Felton, Sharonda
• Primary Examiner(s): Barrett, Thomas C.
• Assistant Examiner(s): BECCIA, CHRISTOPHER J
• Application Number:
  US11/052,641
• Publication Number:
  US 20060178593A1
• Time in Patent Office: 2,528 Days
• Field of Search: 606/79, 606/96, 606/80, 606/86, 606/98, 606/104, 600/554, 600/546, 173/2
• US Class Current: 606/79
• CPC Class Codes: A61B 17/1626 Control means; Display units
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/8875 Screwdrivers, spanners or wrenches
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2090/08021 of the patient or his organs
• CPC Class Codes: A61B 90/03 Automatic limiting or abutting means, e.g. for safety

Abstract

An apparatus for providing medical treatment includes a tool portion configured to operate relative to bone tissue, a handle portion to operate the tool portion, and a nerve monitoring system to detect neural elements. The tool portion includes an insulated shaft comprised of an electrically conductive member and a non-insulated tip. The shaft carries an electrical signal to the non-insulated tip. The handle portion, which is removably and operably connected to the tool portion, incorporates an operating system to operate the tool portion. Additionally, the nerve monitoring system is linked to the tip and is operable to detect a neural element as a function of a characteristic of the electrical signal on the tip. Upon detection of a neural element, the nerve monitoring system provides a signal to the operating system of the handle portion directing the operating system change an operative mode of the tool portion.

Claims

1. An apparatus, comprising:

a tool portion configured to operate relative to bone tissue of a patient, wherein said tool portion includes an insulated shaft extending along a longitudinal axis and comprising an electrically conductive member with a non-insulated tip, wherein said shaft carries an electrical signal to said tip and into the patient;

a handle portion, removably and operably coupled to said tool portion, incorporating an operating system for rotational operation of said tool portion about the longitudinal axis, said handle portion configured to electrically insulate a user of said tool portion from said electrical signal; and

a nerve monitoring system connected to said handle portion, said nerve monitoring system configured to induce an electrical current as said electrical signal at said non-insulated tip, wherein said nerve monitoring system is operable to detect a neural element threshold of a neural element of the patient as a function of said electrical signal, said detection based on an observation of a muscle reaction of the patient to the electrical current interacting with a nerve or based on a detected increase in the electrical current flowing through said non-insulated tip, and provide a signal to said operating system of said handle portion to change an operative mode related to said rotational operation of said tool portion upon detection of the neural element threshold, wherein said change of said operative mode includes reversing a direction of rotation of said tool portion about said longitudinal axis to protect the neural element of the patient.

2. The apparatus of claim 1, wherein:

said operating system includes a circuit operatively coupled to a motor in said handle portion.

3. The apparatus of claim 1, wherein said handle portion includes an elongated cylindrical body extending along said longitudinal axis.

4. The apparatus of claim 1, wherein said tool portion includes a drill to form a hole in the bone tissue.

5. The apparatus of claim 1, wherein said tool portion includes a screw driver to insert an anchor in a hole in the bone tissue.

6. The apparatus of claim 1, wherein said tool portion includes a tap.

7. The apparatus of claim 1, wherein:

said insulated shaft of said tool portion includes a proximal end and a distal end opposite said proximal end;

said distal end includes said non-insulated tip; and

said insulated shaft includes a universal connector at said proximal end fittingly received in said handle portion.

8. The apparatus of claim 1, further comprising a light assembly removably and operably connected to said handle portion to provide light to an area of the bone tissue.

9. The apparatus of claim 1, wherein the bone tissue is within a spinal pedicle wall.

10. The apparatus of claim 1, further comprising a connection link to electrically couple said handle portion to said nerve monitoring system.

11. The apparatus of claim 1, wherein said handle portion includes a pistol grip portion extending therefrom.

12. The apparatus of claim 11, wherein said pistol grip portion is pivotally coupled to said handle portion.

13. The apparatus of claim 11, wherein said pistol grip portion is removably coupled to said handle portion.

14. The apparatus of claim 1, wherein said handle portion is cylindrical.

15. The apparatus of claim 1, wherein said neural element threshold includes a proximity of the neural element to said tip.

16. An apparatus, comprising:

a tool portion configured to operate relative to bone tissue of a patient wherein said tool portion includes an elongated electrically conductive insulated shaft and a non-insulated tip at a distal end of said shaft, wherein said shaft carries an electrical signal to said tip and into the patient; and

a handle portion removably and operably coupled to said tool portion said handle portion configured to electrically insulate a user of said tool portion from an electrical current as the electrical signal induced at said non-insulated tip, said handle portion including a system for rotating said tool portion about a longitudinal axis of said tool portion, wherein said system is operable to automatically change an operative mode of said tool portion by reversing a direction or rotation of said tool portion about said longitudinal axis in response to a signal indicating detection of a neural element threshold of a neural element of the patient as a function of the electrical signal to protect the neural element of the patient, said detection based on an observation of a muscle reaction of the patient to the electrical current interacting with a nerve or based on a detected increase in the electrical current flowing through said non-insulated tie.

17. The apparatus of claim 16, wherein said system includes a motor operable to rotate said tool portion.

18. The apparatus of claim 16, wherein said tool portion is a screw driver engageable to a bone anchor.

19. The apparatus of claim 16, wherein said tool portion is a drill to form a hole in the bone tissue.

20. The apparatus of claim 16, further comprising a light assembly coupled to said handle portion to illuminate an area of the bone tissue.

21. The apparatus of claim 16, wherein said tool portion is a tap to form threads in a hole in the bone tissue.

22. A method, comprising:

providing a handle portion incorporating an operating system;

connecting a tool portion to said handle portion, wherein said tool portion includes an insulated shaft and non-insulated tip, and wherein said handle portion is configured to electrically insulate a user of said tool portion from an electrical signal induced at said non-insulated tip, wherein said operating system is operable to rotate said tool portion about a longitudinal axis thereof;

operably connecting a nerve monitoring system to said tool portion;

providing an electrical current as the electrical signal to said tip and into a patient;

rotating said tool portion relative to bone tissue of the patient;

detecting a neural element threshold of a neural element of the patient as a function of said electrical signal, wherein said detecting is performed by said nerve monitoring system, said detection based on an observation of a muscle reaction of the patient to the electrical current interacting with a nerve or based on a detected increase in the electrical current flowing through said non-insulated tip; and

reversing a direction of rotation of said tool portion upon detection of the neural element threshold in the bone tissue to protect the neural element of the patient, wherein said reversing rotation is a result of a signal sent to said operating system in said handle portion from said nerve monitoring system.

23. The method of claim 22, wherein:

said operating system includes circuitry and a motor operable to rotate said tool portion about the longitudinal axis.

24. The method of claim 22, wherein:

said tool portion is selected from the group consisting of;

a drill, a tap and a driver; and

said tool portion includes a universal connector, opposite said tip, fittingly received in said handle portion.

25. The method of claim 22, wherein the bone tissue is within a spinal pedicle wall.

26. The method of claim 22, further comprising providing a light assembly to illuminate an area of the bone tissue, wherein said light assembly is coupled to said handle portion.

27. The method of claim 22, wherein said neural element threshold includes a proximity of said tip to said neural element.

28. A system, comprising:

a tool portion including an insulated shaft extending along a longitudinal axis and a non-insulated tip, wherein said shaft carries an electrical signal to said tip and into a patient;

a handle portion, operably coupled to said tool portion, said handle portion configured to electrically insulate a user of said tool portion from the electrical signal induced at said non-insulated tip, and configured to rotate said tool portion relative to said handle portion and about the longitudinal axis; and

a nerve monitoring system electrically coupled to said tool portion to provide an electrical current as the electrical signal to said tip to detect neural elements of the patient proximate the tool portion, said detection based on an observation of a muscle reaction of the patient to the electrical current interacting with a nerve or based on a detected increase in the electrical current flowing through said non-insulated tip, wherein said handle portion is operable to rotate said tool portion in a first direction about said longitudinal axis to advance said tool portion toward the bone tissue and said nerve monitoring system is operable to provide a signal to rotate said tool portion in a second direction opposite said first direction upon detection of a neural element of the patient to protect the neural element of the patient.

29. The system of claim 28, wherein said tip is configured to engage a bone screw to deliver a rotary force thereto.

30. The system of claim 28, wherein said tip is configured to drill a hole in the bone tissue.

31. The system of claim 28, wherein a neural element threshold corresponds to a proximity of said tip to a neural element and said nerve monitoring system sends a signal to an operating system in said handle portion to stop rotation of said tool portion upon detection of said neural element threshold.

32. The system of claim 31, wherein said operating system includes a motor operably coupled to said tool portion and circuitry operably linked to said nerve monitoring system.