System and methods for performing percutaneous pedicle integrity assessments

• US 20050004623A1
• Filed: 04/30/2004
• Published: 01/06/2005
• Est. Priority Date: 10/30/2002
• Status: Active Grant

• Current Assignee: Nuvasive Incorporated
• Original Assignee: Nuvasive Incorporated
• Inventors: Martinelli, Scot, Finley, Eric, Elbanna, Jamil, Miles, Patrick, Kaula, Norbert F., Gharib, James, Farquhar, Allen
• Granted Patent: US 7,664,544 B2
• Time in Patent Office: Days
• US Class Current: 607/48
• CPC Class Codes: A61B 17/1626 Control means; Display units
• CPC Class Codes: A61B 17/1655 for tapping
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/1757 for the spine
• CPC Class Codes: A61B 2505/05 Surgical care
• 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 5/1104 induced by stimuli or drugs; A61B5/1102 takes precedence; investigating medicinal preparations G01N33/15
• CPC Class Codes: A61B 5/1106 to assess neuromuscular blockade, e.g. to estimate depth of anaesthesia
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/395 Details of stimulation, e.g. nerve stimulation to elicit EMG response
• CPC Class Codes: A61B 5/4893 Nerves
• CPC Class Codes: A61B 5/6823 Trunk, e.g., chest, back, abdomen, hip
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin

Abstract

The present invention involves systems and related methods for performing percutaneous pedicle integrity assessments involving the use of neurophysiology.

Claims

1. A method for performing percutaneous pedicle integrity assessments, comprising the steps of:

(a) percutaneously introducing an insulation member to a pedicle target site;

(b) establishing electrical communication between a stimulation element and an interior of a pedicle screw pilot hole;

(c) applying a stimulation signal to said stimulation element; and

(d) monitoring to assess whether nerves adjacent said pedicle are innervating as a result of the step of applying said application of stimulation signal to said stimulation element.

2. The method of claim 1 and further, wherein said pedicle target site comprises at least one of a fully inserted pedicle screw and the opening of at least one of an initially formed pedicle screw pilot hole and a prepared pedicle screw pilot hole.

3. The method of claim 1 and further, wherein said insulation member comprises a K-wire insulator.

4. The method of claim 3 and further, wherein step (b) of establishing electrical communication between said stimulation element and said interior of said pedicle screw pilot hole is accomplished by at least one of:

(i) disposing a K-wire through said K-wire insulator such that a distal tip of said K-wire contacts a fully inserted pedicle screw; and

(ii) disposing said K-wire through said K-wire insulator such that said distal tip contacts said interior of said pedicle screw pilot hole.

5. The method of claim 1 and further, wherein step (b) of establishing electrical communication between said stimulation element and said interior of said pedicle screw pilot hole is accomplished by bringing said stimulation element into contact with a tap member disposed through said insulation member.

6. The method of claim 5 and further, wherein said stimulation element is a K-wire, and wherein said tap member is provided with a longitudinal lumen for receiving and passing said K-wire therethrough.

7. The method of claim 1, wherein said insulation member comprises a tubular element is dimensioned to receive a pedicle screw pilot hole preparation tool.

8. The method of claim 7 and further, wherein step (b) of establishing electrical communication between said stimulation element and said interior of said pedicle screw pilot hole is accomplished by:

(i) introducing said pedicle screw pilot hole preparation tool into said pedicle screw pilot hole; and

(ii) establishing electrical communication between said stimulation element and said pedicle screw pilot hole preparation tool.

9. The method of claim 8 and further, wherein said pedicle screw pilot hole preparation tool is a tap member.

10. The method of claim 9 and further, wherein said stimulation member is a K-wire, and wherein said tap member has a longitudinal lumen for receiving and passing a K-wire therethrough to establish electrical communication therebetween.

11. The method of claim 1 and further, wherein said insulating member includes an electrical coupling mechanism for establishing electrical contact between a stimulation source and said stimulation element.

12. The method of claim 1 and further, wherein said stimulation signal is applied directly to said stimulation member through the use of an electrical coupling mechanism in electrical communication with a stimulation source.

13. A method of performing percutaneous pedicle integrity assessments, comprising the steps of:

(a) percutaneously introducing an insulated K-wire into contact with at least one of a pedicle screw and a pedicle screw pilot hole;

(b) applying a stimulation signal to said K-wire; and

(c) monitoring to assess whether nerves adjacent said pedicle are innervating as a result of the step of applying said stimulation signal to said K-wire.

14. A method of performing percutaneous pedicle integrity assessments, comprising the steps of:

(a) percutaneously introducing an insulated member to the approximate opening of a pedicle screw pilot hole;

(b) introducing a pedicle screw pilot hole preparation tool through said insulated member to prepare said pedicle screw pilot hole;

(c) applying a stimulation signal to said pedicle screw pilot hole preparation tool; and

(d) monitoring to assess whether nerves adjacent said pedicle are innervating as a result of the step of applying said stimulation signal to said pedicle screw pilot hole preparation tool.

15. A method of performing percutaneous pedicle integrity assessments, comprising the steps of:

(a) percutaneously introducing an insulated K-wire into contact with a pedicle screw pilot hole;

(b) applying a stimulation signal to said K-wire;

(c) monitoring to assess whether nerves adjacent said pedicle are innervating as a result of the step of applying said stimulation signal to said K-wire;

(d) percutaneously introducing an insulated member to the approximate opening of a pedicle screw pilot hole;

(e) introducing a tap member through said insulated member to prepare said pedicle screw pilot hole;

(f) applying a stimulation signal to said tap member; and

(g) monitoring to assess whether nerves adjacent said pedicle are innervating as a result of the step of applying said stimulation signal to said tap member.

16. A system for performing percutaneous pedicle integrity assessments, comprising:

a body having an aperture dimensioned to receive a stimulation element therethrough and an insulation region capable of being percutaneously introduced to a pedicle target site within a patient; and

a stimulation source in electrical communication with said stimulation element for selectively applying a stimulation signal to said stimulation element to assess whether nerves adjacent said pedicle target site innervate as a result of applying said stimulation signal to said stimulation element.

17. The system of claim 16 and further, wherein said body is a tubular insulated element dimensioned to receive at least one of a K-wire and a pedicle screw pilot hole preparation tool.

18. The system of claim 17 and further, wherein said pedicle screw pilot hole preparation tool is a tap member.

19. The system of claim 17 and further, wherein said tubular insulated element includes an electrical coupling mechanism for establishing electrical contact between said stimulation source and said stimulation element.

20. The system of claim 16 and further, wherein said stimulation signal is applied directly to said stimulation member through the use of an electrical coupling mechanism in electrical communication with said stimulation source.

21. The system of claim 16 and further, comprising an EMG monitoring system for assessing whether nerves adjacent said pedicle target site innervate as a result of applying said stimulation signal to said stimulation element.

22. The system of claim 21 and further, wherein said EMG monitoring system displays at least one of alpha-numeric and graphical information to a user regarding whether nerves adjacent said pedicle target site innervate as a result of applying said stimulation signal to said stimulation element.