APPARATUS, SYSTEMS, AND METHODS FOR PRECISE GUIDANCE OF SURGICAL TOOLS

• US 20160081754A1
• Filed: 11/20/2015
• Published: 03/24/2016
• Est. Priority Date: 10/04/2013
• Status: Active Grant

• Current Assignee: KB Medical SA (Globus Medical, Inc.)
• Original Assignee: KB Medical SA (Globus Medical, Inc.)
• Inventors: Kostrzewski, Szymon, Chappuis, Olivier, Nussbaumer, Billy, Gehriger, Daniel, Berthelin, Roderik
• Granted Patent: US 11,172,997 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/1615 Drill bits, i.e. rotating tools extending from a handpiece to contact the worked material
• CPC Class Codes: A61B 2034/102 Modelling of surgical devices, implants or prosthesis
• CPC Class Codes: A61B 2034/105 Modelling of the patient, e.g. for ligaments or bones
• CPC Class Codes: A61B 2034/107 Visualisation of planned trajectories or target regions
• CPC Class Codes: A61B 2034/2055 Optical tracking systems
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 2090/066 for measuring torque
• CPC Class Codes: A61B 2090/376 using X-rays, e.g. fluoroscopy
• CPC Class Codes: A61B 2090/3762 using computed tomography systems [CT]
• 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 34/30 Surgical robots
• CPC Class Codes: A61B 34/37 Master-slave robots A61B34/35 takes precedence
• CPC Class Codes: A61B 34/70 Manipulators specially adapted for use in surgery
• CPC Class Codes: A61B 34/76 Manipulators having means for providing feel, e.g. force or tactile feedback
• CPC Class Codes: A61B 90/06 Measuring instruments not otherwise provided for
• CPC Class Codes: A61B 90/11 with guides for needles or instruments, e.g. arcuate slides or ball joints
• CPC Class Codes: A61B 90/37 Surgical systems with images on a monitor during operation

Abstract

Described herein are systems, apparatus, and methods for precise placement and guidance of tools during a surgical procedure, particularly a spinal surgical procedure. The system features a portable robot arm with end effector for precise positioning of a surgical tool. The system requires only minimal training by surgeons/operators, is intuitive to use, and has a small footprint with significantly reduced obstruction of the operating table. The system works with existing, standard surgical tools, does not required increased surgical time or preparatory time, and safely provides the enhanced precision achievable by robotic-assisted systems.

Claims

1. A robotic surgical system for performing surgery that permits a surgeon to manually move an end-effector of a robotic arm to a desired position during an operation, the system comprising:

the robotic arm comprising the end-effector;

a force sensor attached to the robotic arm;

a handle extending from the end effector that may be grasped by a hand of a user to position the end effector with at least four degrees of freedom;

a sensor that detects the presence of the hand of the user on the handle, thereby reducing the likelihood that the end-effector is moved unintentionally; and

a processor and a non-transitory computer readable medium storing instructions thereon, wherein the instructions, when executed, cause the processor to;

upon detecting, via the sensor, the hand of the user is on to the handle, releasing a locked position of the end effector and permitting controlled movement of the end effector in response to the force applied to the handle by the user.

2. The system of claim 1, wherein the force sensor is attached to the robotic arm between the end-effector and the robotic arm.

3. The system of claim 1, wherein the handle allows movement of the end-effector by the user with at least six degrees of freedom, wherein the six degrees of freedom are three degrees of translations and three degrees of rotations.

4. The system of claim 1, wherein during the operation movement of the end-effector requires detection, by the sensor, of the hand of the user on the handle.

5. The system of claim 1, wherein the force sensor located between the robotic arm and the end-effector for measuring forces and/or torques applied by the user to a surgical tool held by the end-effector.

6. The system of claim 1, wherein the end-effector comprises a tool holder attached to the robotic arm via a force sensor.

7. The system of claim 6, wherein the tool holder is sized and shaped to hold a first surgical tool.

8. The system of claim 1, comprising:

an actuator for controlled positioning of the end-effector.

9. The system of claim 1, wherein the controlling movement of the end effector in response to the force applied to the handle by the user comprises controlling the actuator to move the end-effector in a direction corresponding to a direction of application of the force.

10. The system of claim 1, wherein the controlling movement of the end effector in response to the force applied to the handle by the user comprises moving the end effector at a predetermined measured pace, wherein the predetermined measured pace is a steady, slow velocity.

11. The system of claim 1, comprising:

a tracking detector for real time detection of (i) a position of a surgical tool held by the robotic arm and (ii) a patient'"'"'s position.

12. The system of claim 11, wherein the patient'"'"'s position is a position of one or more markers arranged to be placed in spatial relation to one or more vertebrae.

13. The system of claim 1, wherein the instructions, when executed, cause the processor to:

access or generate a virtual representation of a patient'"'"'s situation;

obtain a real-time (i) position of the first surgical tool held by the robotic arm and/or end-effector position and (ii) patient'"'"'s position from the tracking detector;

determine a projected trajectory based on the (a) position of the first surgical tool held by the robotic arm and (b) the patient'"'"'s position from the tracking detector; and

display a real-time representation of the projected trajectory, the first surgical tool position in relation to the real-time patient'"'"'s position, wherein determining of the projected trajectory and the displaying of the projected trajectory are automatically updated as the position of the end-effector is changed, thereby providing visual feedback to the user to assist the user in positioning the end-effector at a desired position.

14. The system of claim 13, wherein the desired position is at least one of (i) identified by a surgeon without preoperative planning, (ii) planned with assistance of the robotic surgical system, and (iii) proposed by the robotic surgical system for approval by the surgeon.

15. The system of claim 13, wherein the desired position is planned during the operation.

16. The system of claim 1, wherein the handle comprises one or more buttons.

17. The system of claim 1, comprising:

a first tracking marker for allowing tracking of the position of the first surgical tool by the tracking detector; and

a second tracking marker placed in a known spatial relation to one or more vertebrae, thereby allowing tracking of the one or more vertebrae by the tracking detector.

18. The system of claim 1, wherein the robotic surgical system allows both robotically-assisted and unassisted positioning of the end-effector by the user via the handle.

19. The system of claim 1, wherein the instructions, when executed, cause the processor to:

determine whether the force exceeds a predetermined minimum threshold required for movement of the end-effector.

20. The system of claim 1, wherein a mobile cart that permits the robotic surgical system to be moved in and out of operating room, wherein the mobile cart comprises a plurality of wheels for moving the robotic surgical system and a plurality of rigid legs on which the mobile cart sits to stabilize the robotic surgical system on an operating room floor, wherein either the plurality of wheels or the plurality of rigid legs are retractable.

21. The system of claim 20, wherein the plurality of wheels are retractable and the mobile cart rests on the plurality of rigid legs when the plurality of wheels are retracted.

22. The system of claim 20, wherein the plurality of rigid legs are retractable and the mobile cart rests on the plurality of wheels when the plurality of rigid legs are retracted.

23. The system of claim 19, wherein the threshold is greater than or equal to zero.

24. The system of claim 1, wherein the end-effector can be positioned with at least four degrees of freedom.

25. The system of claim 1, wherein the first surgical tool is a drill bit tube sized and shaped to receive a drill bit, tap, screwdriver, or implant (with or without extender) therethrough.

26. The system of claim 1, wherein the surgery is spinal surgery.

27. The system of claim 1, wherein the tool holder comprises a tool guide attached to the robotic arm and sized and shaped to slidably receive and/or hold the first surgical tool.

28. The system of claim 1, wherein the end-effector is sized and shaped to releasably hold the first surgical tool, allowing the first surgical tool to be removed and replaced with a second surgical tool.

29. The system of claim 1, wherein the instructions further cause the processor to:

upon entry of a user command, control the actuator to translate the end-effector an identified distance in an identified direction and/or to adjust an angle of rotation of the end-effector.

30. A robotic surgical system for performing surgery that permits a surgeon to manually move an end-effector of a robotic arm to a desired position during an operation, the system comprising:

a force sensor attached to the robotic arm;

a manipulator that may be grasped by a hand of a user to position the end effector with at least four degrees of freedom;

a sensor; and

a processor and a non-transitory computer readable medium storing instructions thereon, wherein the instructions, when executed, cause the processor to;

upon detecting, via the sensor, an activation by the user, releasing a locked position of the end effector and permitting controlled movement of the end effector in response to the force applied to the manipulator by the user.