Robot guided oblique spinal stabilization

• US 8,992,580 B2
• Filed: 12/01/2009
• Issued: 03/31/2015
• Est. Priority Date: 12/01/2008
• Status: Active Grant

• Current Assignee: Mazor Robotics, Ltd (Medtronic Plc)
• Original Assignee: Mazor Robotics, Ltd (Medtronic Plc)
• Inventors: Bar, Yossef, Zehavi, Eli, Lieberman, Isador, Shoham, Moshe
• Primary Examiner(s): BECCIA, CHRISTOPHER J
• Application Number:
  US13/132,095
• Publication Number:
  US 20110319941A1
• Time in Patent Office: 1,946 Days
• Field of Search: 606/86.A, 606/86.R, 606/96, 606/104, 606246-279
• US Class Current: 606/279
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/1757 for the spine
• CPC Class Codes: A61B 17/320016 Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take precedence
• CPC Class Codes: A61B 17/3205 Excision instruments
• CPC Class Codes: A61B 17/7001 Screws or hooks combined with longitudinal elements which do not contact vertebrae A61B17/7058 takes precedence
• CPC Class Codes: A61B 17/7064 Devices acting on, attached to, or simulating the effect of, vertebral facets; Tools therefor
• CPC Class Codes: A61B 2017/00261 Discectomy
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00685 Archimedes screw
• CPC Class Codes: A61B 2017/0256 for the spine
• CPC Class Codes: A61B 2017/3407 including a base for support on the body
• CPC Class Codes: A61B 2017/564 Methods for bone or joint treatment
• CPC Class Codes: A61B 2034/107 Visualisation of planned trajectories or target regions
• CPC Class Codes: A61B 2034/303 specifically adapted for manipulations within body lumens, e.g. within lumen of gut, spine, or blood vessels
• CPC Class Codes: A61B 2090/3762 using computed tomography systems [CT]
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 34/30 Surgical robots
• CPC Class Codes: A61B 90/11 with guides for needles or instruments, e.g. arcuate slides or ball joints
• CPC Class Codes: A61B 90/50 Supports for surgical instruments, e.g. articulated arms

Abstract

A robotic system for performing minimally invasive spinal stabilization, using two screws inserted in oblique trajectories from an inferior vertebra pedicle into the adjacent superior vertebra body. The procedure is less traumatic than such procedures performed using open back surgery, by virtue of the robot used to guide the surgeon along a safe trajectory, avoiding damage to nerves surrounding the vertebrae. The robot arm is advantageous since no access is provided in a minimally invasive procedure for direct viewing of the operation site, and the accuracy required for oblique entry can readily be achieved only using robotic control. This robotic system also obviates the need for a large number of fluoroscope images to check drill insertion position relative to the surrounding nerves. Disc cleaning tools with flexible wire heads are also described. The drilling trajectory is determined by comparing fluoroscope images to preoperative images showing the planned path.

Claims

1. A system for performing a minimally invasive spinal stabilization procedure between two adjacent vertebrae of a subject, the system comprising:

a surgical robot mounted such that it defines at least one path for oblique screw insertion from the pedicle region in an inferior one of said two adjacent vertebrae into the body of the adjacent superior vertebra, towards its anterior cortical rim;

a control system receiving three-dimensional preoperative data, including information regarding the spatial location of the bone structures and the nerve positions of said two adjacent vertebrae; and

a registration system to relate the coordinate system of said surgical robot with said three-dimensional preoperative data,

wherein said control system is adapted to use said information to determine a safe path for said oblique screw insertion, such that said spinal stabilization procedure can be performed by minimally invasive techniques without direct viewing of anatomical details of said vertebrae.

2. A system according to claim 1, wherein said at least one safe path is a path in the coordinate system of said surgical robot, which does not approach either the course of a nerve of the subject, or a bone structure of the subject which it is not intended to intersect, as determined from said three-dimensional preoperative data.

3. A system according to claim 1, wherein said three-dimensional preoperative data is obtained from any one of CT scans, MRI scans and ultrasound images.

4. A system according to claim 1, wherein said control system is adapted to inhibit said robot from executing a path in the coordinate system of said surgical robot, which would approach the course of a nerve of the subject, as determined in said three-dimensional preoperative data.

5. A system according to claim 1, wherein said safe path passes through a pedicle of said inferior vertebra, and is determined by said control system using criteria which further ensure that said safe path does not break out of the cortical wall of said pedicle.

6. A system according to claim 1, wherein said registration system comprises an image processing module for comparison of anatomical topological features of the subject in said three-dimensional preoperative data with those same features in fluoroscope images of said vertebrae.

7. A system according to claim 1, wherein said registration system includes a target having predefined marker features, said target being disposed in a predetermined position and orientation relative to said robot, such that images of said target in said fluoroscope images enable the co-ordinate system of said robot to be related to that of fluoroscope images of said vertebrae.

8. A system according to claim 1, wherein said registration system utilizes a navigational system to relate the co-ordinate system of said robot to fluoroscope images of said vertebrae.

15. A system according to claim 1, wherein said system enables performance of said minimally invasive spinal stabilization procedure on non-spondylolisthesic subjects.

9. A method for performing a minimally invasive procedure for spinal stabilization between two adjacent vertebrae of a subject, the method comprising:

generating three-dimensional preoperative data including information regarding the spatial location of the bone structures and nerve positions associated with said two adjacent vertebrae;

using said three-dimensional preoperative data to plan at least one safe path for oblique screw insertion, from the pedicle region in an inferior one of said two adjacent vertebrae into the body of the adjacent superior vertebra towards its anterior cortical rim;

mounting a surgical robot such that it can delineate said at least one safe path;

registering the coordinate system of said robot to said three-dimensional preoperative data;

utilizing said surgical robot to generate a drilled hole along one of said at least one planned paths; and

inserting a screw obliquely between said inferior and superior vertebrae through said drilled hole.

wherein said method enables said spinal stabilization procedure to be performed by minimally invasive techniques without direct viewing of anatomical details of said vertebrae.

10. A method according to claim 9, wherein said at least one safe path is two safe paths, one on each lateral side of said vertebrae, such that two screws may be inserted obliquely between said inferior and superior vertebrae.

11. A method according to claim 9, wherein said at least one safe path is planned to avoid undesired collisions with a bone structure of the subject, or encroachment on the path of a nerve of the subject.

12. A method according to claim 9, wherein said step of registering the coordinate system of said robot to said three-dimensional preoperative data comprises the step of comparing anatomical topological features of the subject in said three-dimensional preoperative data with those same features in fluoroscope images of said vertebrae.

13. A method according to claim 9, further comprising the step of disposing a target having predefined marker features in a predetermined position and orientation relative to said robot, such that images thereof in said fluoroscope images enable the co-ordinate system of said robot to be related to that of fluoroscope images of said vertebrae.

14. A method according to claim 9, further comprising the step of relating the co-ordinate system of said robot to fluoroscope images of said vertebrae by means of a navigational system.

16. A method according to claim 9, wherein said method enables performance of said spinal stabilization procedure on non-spondylolisthesic subjects.

17. A method for performing spinal stabilization between two adjacent vertebrae of a subject, the method comprising:

drilling two oblique posterior entry passages, one from each pedicle region in an inferior one of said two adjacent vertebrae into the body of the adjacent superior vertebra towards its anterior cortical rim;

cleaning the disc space between said two adjacent vertebrae;

accessing said disc space between said two adjacent vertebrae through a first one of said oblique posterior entry passages, and distracting said two adjacent vertebrae;

inserting a screw obliquely into said inferior and superior vertebrae along the other one of said oblique posterior entry passages, such that said vertebrae are mutually fixed in position; and

inserting a second screw obliquely between said inferior and superior vertebrae along the first one of said oblique posterior entry passages, such that said vertebrae are firmly fixed in position.

18. The method of claim 17, further comprising the step of inserting bone grafting material into said disc space through said first oblique posterior entry passage after distracting said two adjacent vertebrae.

19. The method of claim 17, wherein said oblique posterior entry passages are drilled with the aid of a robot.

20. The method of claim 17, wherein said oblique posterior entry passages are drilled using a mechanical positioner aligned by a surgeon.

21. The method of claim 17, wherein said method enables performance of said spinal stabilization procedure on non-spondylolisthesic subjects.