US2021186617A1PendingUtilityA1

Surgical Monitoring System and Related Methods For Spinal Pedicle Screw Alignment

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Assignee: NUVASIVE INCPriority: Oct 24, 2007Filed: Mar 8, 2021Published: Jun 24, 2021
Est. expiryOct 24, 2027(~1.3 yrs left)· nominal 20-yr term from priority
A61B 6/547A61B 6/12A61B 34/20A61N 1/0551A61B 6/4441A61B 17/1703A61F 2002/4668A61B 90/37A61B 2034/2046A61B 2090/067A61B 5/24A61B 6/461A61B 34/10A61F 2/4657A61B 5/388
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Claims

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

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A method comprising:
 receiving, at a computer, gravitational angular orientation data during a spine surgery from a tilt sensor coupled to an instrument;   determining, with the computer and based on the gravitational angular orientation data, a first angular orientation between two locations of anatomical structures within a first fluoroscopic image based on a vertical reference line relative to gravity and a medial-lateral trajectory line from a central position in a pedicle to an anterior point of a vertebral body;   determining, with the computer and based on the gravitational angular orientation data, a second angular orientation between two locations of anatomical structures within a second fluoroscopic image;   displaying, at a display communicatively linked to the computer, a first indicia of the first angular orientation between two locations within the first fluoroscopic image;   displaying, at the display, a second indicia of the second angular orientation between two locations within the second fluoroscopic image;   displaying, at the display, a third indicia of a variance between the first angular orientation and a first predetermined target angle;   displaying, at the display, a fourth indicia of a variance between the second angular orientation and a second predetermined target angle; and   displaying, at the display, the first fluoroscopic image or the second fluoroscopic image.   
     
     
         2 . The method of  claim 1 ,
 wherein the third indicia includes at least one of:
 a first color indicative of an optimal variance between the first angular orientation and the first predetermined target angle; 
 a second color indicative of an unacceptable variance between the first angular orientation and the first predetermined target angle, and 
 a third color indicative of an acceptable yet not optimal variance between the first angular orientation and the first predetermined target angle. 
   
     
     
         3 . The method of  claim 1 , further comprising:
 providing one or more instructions for overlaying a virtual protractor on the display.   
     
     
         4 . The method of  claim 3 , further comprising:
 determining an angular orientation between a plurality of locations according to a plurality of points associated with the virtual protractor on the display.   
     
     
         5 . The method of  claim 4 , further comprising:
 receiving one or more inputs adjusting at least one of the plurality of points associated with the virtual protractor.   
     
     
         6 . The method of  claim 1 ,
 wherein the second angular orientation between the two locations within the second fluoroscopic image is based on a vertical reference line relative to gravity and the medial-lateral trajectory line.   
     
     
         7 . The method of  claim 1 , further comprising:
 monitoring neurophysiologic changes.   
     
     
         8 . The method of  claim 1 , further comprising:
 receiving one or more inputs for adjusting at least one of the first predetermined target angle and the second predetermined target angle intraoperatively.   
     
     
         9 . A method comprising:
 receiving gravitational angular orientation data during a spinal surgery from a tilt sensor coupled to an instrument;   determining a first angular orientation between two anatomical structures within a first fluoroscopic image based on:
 an angle between a vertical reference line relative to gravity and a medial-lateral trajectory line from a central position in a pedicle to an anterior point of a vertebral body; or 
 an angle between virtual reference line relative to graving and a cranial-caudal trajectory line of a spine from a central position in the pedicle to an anterior point of the vertebral body; 
   determining a second angular orientation between two anatomical structures within a second fluoroscopic image based on the gravitational angular orientation data;   displaying a first indicia of the first angular orientation;   displaying a second indicia of the second angular orientation;   displaying a third indicia of a variance between the first angular orientation and a predetermined target angle; and   displaying a fourth indicia of a variance between the second angular orientation and a second predetermined target angle.   
     
     
         10 . The method of  claim 9 , wherein the third indicia is:
 a first color indicative of an optimal variance between the first angular orientation and the predetermined target angle;   a second color indicative of an unacceptable variance between the first angular orientation and the predetermined target angle; or   a third color indicative of an acceptable yet not optimal variance between the first angular orientation and the predetermined target angle.   
     
     
         11 . The method of  claim 9 , further comprising:
 overlaying a virtual protractor on the display;   determining an angular orientation between a plurality of locations within a fluoroscopic image according to a plurality of points associated with the virtual protractor; and   receiving one or more inputs for adjusting at least one of the plurality of points associated with the virtual protractor.   
     
     
         12 . A method comprising:
 receiving gravitational angular orientation data from a tilt sensor coupled to an instrument;   determining a first angular orientation between two anatomical structures within a first fluoroscopic image based on a line from a central position in a pedicle to an anterior point of a vertebral body relative to gravity; and   determining a second angular orientation between two anatomical structures within a second fluoroscopic image;   determining a first variance between the first angular orientation and a first predetermined target angle;   determining a second variance between the second angular orientation and a second predetermined target angle;   displaying a first indicia of the first variance; and   displaying a second indicia of the second variance.   
     
     
         13 . The method of  claim 12 , further comprising:
 selecting a first color responsive to the first variance being an optimal variance between the first angular orientation and the predetermined target angle;   selecting a second color responsive to the first variance being an unacceptable variance between the first angular orientation and the predetermined target angle; and   selecting a third color responsive to the first variance being an acceptable yet not optimal variance between the first angular orientation and the predetermined target angle.   
     
     
         14 . The method of  claim 12 , further comprising:
 providing a virtual protractor;   determining an angular orientation between a plurality of locations according to a plurality of points associated with the virtual protractor on the display; and   adjusting at least one of the plurality of points associated with the virtual protractor.   
     
     
         15 . The method of  claim 12 , further comprising:
 monitoring neurophysiologic changes.   
     
     
         16 . The method of  claim 12 , further comprising:
 receiving one or more inputs for adjusting at least one of the predetermined angle and the second predetermined angle intraoperatively.   
     
     
         17 . The method of  claim 12 , further comprising:
 obtaining additional angular orientation data from a sensor coupled to an intraoperative imaging device; and   providing an indicia of the additional angular orientation data.   
     
     
         18 . The method of  claim 12 , further comprising:
 activating one or more lights coupled to the instrument based on a direction the instrument must travel to align with a vertebral pedicle based on the first or second angular orientation.   
     
     
         19 . The method of  claim 12 , further comprising:
 advancing a distal end of the instrument into a vertebral pedicle.   
     
     
         20 . The method of  claim 12 , further comprising:
 providing feedback of angular orientation of the instrument with a floating graphic moving relative to a center of a fixed graphic.

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