Surgical Trajectory Monitoring System and Related Methods

• US 20100312103A1
• Filed: 10/24/2008
• Published: 12/09/2010
• Est. Priority Date: 10/24/2007
• Status: Active Grant

• Current Assignee: Nuvasive Incorporated
• Original Assignee: Nuvasive Incorporated
• Inventors: Barnes, Jeff, Eis, Rick, Finley, Eric, Gorek, Josef, Kim, Albert C.
• Granted Patent: US 9,119,572 B2
• Time in Patent Office: Days
• US Class Current: 600/425
• CPC Class Codes: A61B 17/1703 using imaging means, e.g. by X-rays
• CPC Class Codes: A61B 2034/2046 Tracking techniques
• CPC Class Codes: A61B 2090/067 for measuring angles
• CPC Class Codes: A61B 34/10 Computer-aided planning, simulation or modelling of surgical operations
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/388 Nerve conduction study, e.g. detecting action potential of peripheral nerves
• CPC Class Codes: A61B 6/12 Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61B 6/4441 the rigid structure being a C-arm or U-arm
• CPC Class Codes: A61B 6/461 Displaying means of special interest
• CPC Class Codes: A61B 6/547 involving tracking of position of the device or parts of the device
• CPC Class Codes: A61B 90/37 Surgical systems with images on a monitor during operation
• CPC Class Codes: A61F 2/4657 Measuring instruments used for implanting artificial joints for surgical instruments A61B90/06
• CPC Class Codes: A61F 2002/4668 for measuring angles
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes

Abstract

The present invention relates to a system and methods generally aimed at monitoring the trajectory of surgical instruments and especially for monitoring the trajectory of surgical instrument used during pedicle fixation to ensure the proper placement of pedicle screws.

Claims

1. A method for cannulating a vertebral pedicle in a body comprising the steps of:

a. coupling a first orientation sensor to an intraoperative imaging device, said sensor operable to determine a first angular relationship in a first plane between said sensor and a reference direction and operable to determine a second angular relationship in a second plane between said sensor and said reference direction, wherein said second plane is orthogonal to said first plane and said sensor is coupled to said imaging device in a known orientation, said sensor being communicatively linked to a control unit;

b. capturing an image of said vertebral pedicle with said imaging device oriented in a first position;

c. using said control unit to measure a value representing an angular orientation of said pedicle;

d. coupling a second orientation sensor to a surgical instrument;

e. adjusting the orientation of said instrument until said second orientation sensor indicates that the instrument is aligned with said measured value; and

f. advancing a distal end of said instrument through said body and into said pedicle.

2. The method of claim 1, comprising the additional step of rotating said imaging device into a second position prior to advancing said instrument into said pedicle.

3. The method of claim 2, wherein said first position is a lateral position.

4. The method of claim 3, wherein said second position is an oblique position.

5. The method of claim 2, comprising the additional step of directing a laser beam from said imaging device to a preferred entry site for said instrument on said body.

6. The method of claim 5, wherein said laser beam creates a cross pattern over said preferred entry point.

7. The method of claim 6, wherein said laser beam is directed from a reticle coupled to the imaging device.

8. The method of claim 1, wherein said second orientation sensor indicates alignment with said measured value via at least one lead light coupled to said sensor.

9. The method of claim 8, wherein said sensor includes multiple LED lights that light according to the direction the instrument must travel to align with said measured angle.

10. The method of claim 8, wherein said sensor couples to a handle of said instrument and said LED light is adjacent to said handle.

11. A system for use during spinal surgery, comprising:

a control unit configured to direct the performance of a neurophysiologic test including at least one of a pedicle integrity test, nerve detection, free run EMG, MEP, and SSEP;

said control unit being communicatively linked an orientation sensor operable to determine a first angular relationship in a first plane between said sensor and a reference direction and operable to determine a second angular relationship in a second plane between said sensor and said reference direction, wherein said second plane is orthogonal to said first plane and said sensor is coupled to said imaging device in a known orientation; and

a display communicatively linked to said control unit, said display configured to display a first result including at least one of alpha-numeric, graphic, and color indicia related to said neurophysiologic test, said display being further configured to display a second result include at least one of alpha-numeric, graphic, and color indicia related to least one of said determined first and second angular relationships between said sensor and said reference direction.

12. The system of claim 11, wherein said display is configured to show said first result and said second result simultaneously.

13. The system of claim 12, wherein said display is further configured to show a third result including at least one of live video and a still image.

14. The system of claim 13, wherein at least one of said live video and said still image is a fluoroscopic image.

15. The system of claim 11 wherein said orientation sensor comprises at least one accelerometer and said reference direction is gravity.

16. The system of claim 11, wherein said orientation sensor is coupled to a surgical instrument.

17. The system of claim 16, wherein said surgical instrument is a pedicle access instrument.

18. The system of claim 16, wherein said orientation sensor is further configured to deliver a stimulation signal to said surgical instrument.

19. The system of claim 18, wherein said stimulation signal is part of said neurophysiologic test.

20. The system of claim 11, wherein said color indicia includes at least one of a green color indicative of an optimal variance between said trajectory of said instrument and at least one of the first and second determined angular relationships between said sensor and said reference direction, a red color indicative of an unacceptable variance between said trajectory of said instrument and at least one of the first and second determined angular relationships between said sensor and said reference direction, and a yellow color indicative of an acceptable yet not optimal variance between said trajectory of said instrument and at least one of the first and second determined angular relationships between said sensor and said reference direction.