Monitoring trajectory of surgical instrument during the placement of a pedicle screw

• US 9,119,572 B2
• Filed: 10/24/2008
• Issued: 09/01/2015
• Est. Priority Date: 10/24/2007
• Status: Active Grant

• Current Assignee: Nuvasive Incorporated
• Original Assignee: Nuvasive Incorporated
• Inventors: Gorek, Josef, Finley, Eric, Kim, Albert C., Barnes, Jeff, Eis, Rick
• Primary Examiner(s): Jung, Unsu
• Assistant Examiner(s): Akar, Serkan
• Application Number:
  US12/739,950
• Publication Number:
  US 20100312103A1
• Time in Patent Office: 2,503 Days
• Field of Search: 600/427, 606/96, 606/104
• US Class Current: 1/1
• 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 first orientation sensor operable to determine a first angular relationship in a first plane between said first orientation sensor and a reference direction and operable to determine a second angular relationship in a second plane between said first orientation sensor and said reference direction, wherein said second plane is orthogonal to said first plane and said first orientation sensor is coupled to said intraoperative imaging device in a known orientation, said first orientation sensor being communicatively linked to a control unit, said control unit comprising a computer;

b. capturing an image of said vertebral pedicle with said intraoperative imaging device, said intraoperative device being positioned in a first position during said image capture;

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

d. coupling a second orientation sensor to a surgical instrument, said second orientation sensor operable to determine a third angular relationship in said first plane between said second orientation sensor and a reference direction and operable to determine a fourth angular relationship in said second plane between said second orientation sensor, wherein said second orientation sensor is coupled to said surgical instrument in a known orientation, said second orientation sensor being communicatively linked to a control unit;

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

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

2. The method of claim 1, comprising the additional step of rotating said imaging device into a second position prior to advancing said surgical instrument into said vertebral 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 intraoperative imaging device to a preferred entry site for said surgical instrument on said body.

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

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

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

9. The method of claim 8, wherein said second orientation sensor includes multiple LED lights that light according to the direction the instrument must travel to align with said value representing the angular orientation of said vertebral pedicle.

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

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

a control unit comprising a computer, said control unit configured to direct the advancement of a pedicle access instrument;

said control unit being communicatively linked to a first orientation sensor operable to determine a first angular relationship in a first plane between said first orientation sensor and a reference direction and operable to determine a second angular relationship in a second plane between said first orientation sensor and said reference direction, wherein said second plane is orthogonal to said first plane and said first orientation sensor is coupled to an imaging device in a known orientation, said control unit operable to define a first trajectory setting based on the determined first angular relationship and second angular relationship when said imaging device is oriented in a desired position;

said control unit further being communicatively linked to a second orientation sensor operable to determine a third angular relationship in said first plane between said second orientation sensor and a reference direction and operable to determine a fourth angular relationship in said second plane between said second orientation sensor and said reference direction, wherein said second orientation sensor is coupled to said pedicle access instrument; and

a display communicatively linked to said control unit, said display configured to display alpha-numeric, graphic, and color indicia related to said first trajectory setting, said display being further configured to display alpha-numeric, graphic, and color indicia related to said second orientation sensor, said alpha-numeric, graphic, and color indicia, indicating a trajectory of said pedicle access instrument is aligned with said first trajectory.

12. The system of claim 11, wherein said display is further configured to show at least one of live video and a still image.

13. The system of claim 12, wherein at least one of said live video and said still image is a fluoroscopic image.

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

15. The system of claim 11, wherein said second orientation sensor is further configured to transmit a stimulation signal to said pedicle access instrument.

16. The system of claim 15, wherein said stimulation signal is part of said neurophysiologic a pedicle integrity test.

17. 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 surgical instrument and said first trajectory, a red color indicative of an unacceptable variance between said trajectory of said surgical instrument and said first trajectory, and a yellow color indicative of an acceptable yet not optimal variance between said trajectory of said surgical instrument and said first trajectory.