Surgical monitoring system and related methods for spinal instrument angular relation

• US 9,795,451 B2
• Filed: 08/31/2015
• Issued: 10/24/2017
• 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, Jeffrey, Eis, Rick
• Primary Examiner(s): Akar, Serkan
• Application Number:
  US14/841,270
• Publication Number:
  US 20150366630A1
• Time in Patent Office: 785 Days
• 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 angular orientation between two locations within a fluoroscopic image and especially for monitoring the angular orientation between two locations within a fluoroscopic image and a predetermined target angle.

Claims

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

a control unit comprising a computer,

a fluoroscope in communication with the control unit;

a reticle comprising a laser, and one or more radiopaque markers, said reticle attached to an image intensifier on the fluoroscope;

a spinal surgical instrument with a tilt sensor; and

a display communicatively linked to said control unit;

wherein said control unit is configured to receive a fluoroscopic image from the fluoroscope, obtain a reading of a gravitational angular orientation from the tilt sensor of the spinal surgical tool, and determine an angular orientation between at least two image locations within the fluoroscopic image;

and wherein, said display is configured to display at least one of a first alpha-numeric, graphic, and color indicia related to the angular orientation between the at least two image locations within the fluoroscopic image, wherein the angular orientation between the at least two image locations is based on a vertical reference line relative to gravity and one of a medial-lateral trajectory line and a cranial-caudal trajectory line of a spine.

2. The system of claim 1, wherein the medial-lateral trajectory line is a line from a central position in a pedicle to an anterior point of a vertebral body.

3. The system of claim 1, wherein the cranial-caudal trajectory line is a line from a central position in a pedicle to an anterior point of a vertebral body.

4. The system of claim 1, wherein the fluoroscopic image is a lateral image in relation to a direction of gravity.

5. The system of claim 1, wherein the control unit is further configured to monitor neurophysiologic changes in and adjacent the spine.

6. The system of claim 1 further comprising, the display being further configured to display at least one of a second alpha-numeric, graphic, and color indicia indicative of a relationship between said angular orientation and a target.

7. The system of claim 6, wherein said second color indicia includes at least one of a green color indicative of an optimal relationship between said angular orientation and the target, a red color indicative of an unacceptable relationship between said angular orientation and the target, and a yellow color indicative of an acceptable yet not optimal relationship between said angular orientation and the target.

8. The system of claim 6, wherein the target is a cranial-caudal angle.

9. The system of claim 1, wherein the tilt sensor is in communication with the control unit.

10. The system of claim 1, wherein the reticle further comprises an integrated tilt sensor.

11. The system of claim 1, wherein the radiopaque marker is a cross-hair.

12. A non-transitory computer readable medium with computer executable instructions stored thereon, that when executed on a processor, perform the steps of:

receive a fluoroscopic image from a C-arm fluoroscopy device;

determine from a lateral fluoroscopic image a first spinal angle relative to a direction of gravity;

create a first angular relationship between the first spinal angle and a relationship target, wherein the relationship target is based on the first spinal angle and a second spinal angle;

convert the first angular relationship to at least one of a first colored indicia, a first graphic, and a first numerical indicia;

display the at least one of the first colored indicia, the first graphic, and the first numerical indicia;

obtain a reading of a gravitational angular orientation from a tilt sensor of a spinal surgical tool;

determine from the tilt sensor reading an intra-operative angle of the surgical tool from a transverse and a sagittal plane with respect to the acting direction of gravity;

create a second angular relationship between the intra-operative angle and the relationship target;

convert the second angular relationship to at least one of a second colored indicia, a second graphic, and a second numerical indicia; and

display the at least one of the second colored indicia, the second graphic, and the second numerical indicia.

13. The medium of claim 12, further comprising determine a plurality of desired angles at a plurality of levels of a spine.

14. The medium of claim 12, wherein the relationship target is determined preoperatively.

15. The medium of claim 12, further comprising adjust the relationship target intraoperatively.

16. The medium of claim 12, further comprising provide a plurality of colored indicia based on a plurality of relationships between the first spinal angle and the relationship target.

17. The medium of claim 12, further comprising provide a ball and stick feedback based on the relationship.

18. A method for establishing a surgical trajectory, comprising:

providing a computer processor to perform the steps of;

receiving a lateral fluoroscopic image from a C-arm fluoroscopy device;

determining from the lateral fluoroscopic image a first spinal angle relative to a direction of gravity;

creating an angular relationship between the first spinal angle and a relationship target, wherein the relationship target is based on the first spinal angle and a second spinal angle based on the lateral fluoroscopic image;

converting the relationship to at least one of a colored indicia and a numerical indicia;

obtaining a reading of a gravitational angular orientation from a tilt sensor of a spinal surgical tool; and

identifying a proper trajectory for a spinal surgical instrument by angulating the surgical instrument in a sagittal plane and a transverse plane until the reading of the tilt sensor on the spinal surgical instrument conforms to the relationship target.