IP Library Granted Patent US 12,343,092
Granted Patent B2
US 12,343,092 · App. 18/325,107 · Granted Jul 1, 2025

System and method for monitoring offset during navigation-assisted surgery

Inventors: James G. Walen (Portage, MI); Zachary Bolthouse (Kalamazoo, MI)
Assignee: Stryker Corporation
A61B34/20A61B17/15A61B17/1703A61B17/1757A61B34/10A61B2017/00039A61B2017/00119A61B2017/00123A61B2017/00199A61B2017/00398A61B2034/104A61B2034/105A61B2034/2051A61B2034/2057A61B2034/2072A61B2217/005
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Quick Facts
Patent No.
US 12,343,092
App. No.
18/325,107
Granted
Jul 1, 2025
Kind
B2
Abstract

Surgical systems and methods for tracking physical objects near a target site during a surgical procedure are provided, the surgical system employs a navigation system and a surgical instrument; an instrument tracker is provided on the surgical instrument and a patient tracker is provided on the patient's target tissue; the system and method is configured to detect an error condition compromising accuracy of the navigation guidance and to track and monitor a tool-to-bone offset.

Claims (52)

1. A surgical system comprising:

a surgical instrument having an actuator and a tool tip;

a controller for providing power to the surgical instrument, the controller operable to monitor an actuator operation of the instrument during a medical procedure;

an instrument tracker coupled to the surgical instrument;

a patient tracker to be coupled to a tissue; and

a navigation system including a localizer having a localizer coordinate system, the localizer operable to register the patient tracker in the localizer coordinate system, defining a location of the tissue relative to the localizer coordinate system, and to register the instrument tracker in the localizer coordinate system, defining a location of the instrument tool tip relative to the localizer coordinate system,

wherein the navigation system is operable to monitor a position of the instrument tool tip relative to the tissue to determine when the instrument tool tip is in contact with the tissue in the localizer coordinate system, and

wherein the controller and the navigation system are in electronic communication and configured to cooperate to:

define an actuator operation for the instrument when the instrument tool tip is not in contact with the tissue;

compare the monitored actuator operation to the monitored position of the instrument tool tip;

determine an error condition when the monitored position of the instrument tool tip is in contact with the tissue in the localizer coordinate system and the monitored actuator operation equals the defined actuator operation for the instrument when the instrument tool tip is not in contact with the tissue; and

trigger an action when an error condition is determined.

2. The system of claim 1 , wherein defining the actuator operation for the instrument when the tool tip is not in contact with the tissue comprises defining a threshold value for power, voltage, current, or combinations thereof, when the actuator is operated while the instrument tool tip is not in contact with tissue.

3. The system of claim 1 , wherein the controller and the navigation system are configured to cooperate to define a second actuator operation for the instrument when the instrument tool tip is in contact with the tissue; determine a second error condition when the monitored position of the instrument tool tip is not in contact with the tissue in the localizer coordinate system and the monitored actuator operation equals the second defined actuator operation for the instrument when the instrument tool tip is in contact with the tissue; and trigger a second action when the second error condition is determined.

4. The system of claim 3 , wherein triggering one of an action or a second action comprises one of sounding an audible alert, displaying a visual alert, activating a tactile alert, cutting off power to the surgical instrument, or combinations thereof.

5. A surgical system comprising:

a surgical instrument having an actuator and a tool tip

a controller for providing power to the surgical instrument, the controller operable to monitor an actuator operation of the instrument during a medical procedure;

an instrument tracker coupled to the surgical instrument;

a patient tracker to be coupled to a tissue; and

a navigation system including a localizer having a localizer coordinate system, the localizer operable to the patient tracker in the localizer coordinate system, defining a location of the tissue relative to the localizer coordinate system, and to register the instrument tracker in the localizer coordinate system, defining a location of the instrument tool tip relative to the localizer coordinate system,

wherein the navigation system is configured to monitor a position of the instrument tool tip relative to the tissue in the localizer coordinate system, and

wherein the controller and the navigation system are in electronic communication and configured to cooperate to:

define a first actuator operation of the surgical instrument operating while not in contact with the tissue;

compare the monitored actuator operation to the defined actuator operation;

determine a contact time between the instrument tool tip and the tissue when the monitored actuator operation deviates from the defined first actuator operation; and

determine a tool-to-bone offset as a distance between the instrument tool tip and a surface of the tissue in the localizer coordinate system.

6. The system of claim 5 , wherein at least one of the navigation system and the controller is configured to trigger an action when the tool-to-bone offset exceeds a predefined threshold, the action comprising one of sounding an audible alert, displaying a visual alert, activating a tactile alert, cutting off power to the surgical instrument, or combinations thereof.

7. The system of claim 6 , wherein the predefined threshold is 0.5 millimeters.

8. The system of claim 5 , further comprising a display device, wherein at least one of the controller and the navigation system is configured to cause the display device to display the determined tool-to-bone offset.

9. The system of claim 8 , wherein the controller and the navigation system are configured to cooperate to determine each occurrence during the medical procedure of the monitored position of the instrument tool tip being in contact with the surface of the tissue and logging a series of tool-to-bone offset values determined during the medical procedure upon each occurrence.

10. The system of claim 9 , wherein at least one of the navigation system and the controller is configured to cause the display device to display the series of tool-to-bone offsets as one of a serially updating value, a chart of tool-to-bone offsets over time, or combinations thereof.

11. The system of claim 8 , wherein displaying the determined tool-to-bone offset comprises displaying the determined tool-to-bone offset in a first color when the determined tool-to-bone offset is less than a first level magnitude, displaying the determined tool-to-bone offset in a second color, different from the first color, when the determined tool-to-bone offset is between the first level magnitude and a second level magnitude; and displaying the determined tool-to-bone offset in a third color, different from the first and the second colors, when the determined tool-to-bone offset is greater than the second level magnitude.

12. The system of claim 11 , wherein the controller is configured to disable power to the surgical instrument when the determined tool-to-bone offset is greater than a third level magnitude greater than the first and second level magnitudes.

13. The system of claim 6 , wherein the navigation system is configured to prompt a user to enter a value for the predefined threshold.

14. The system of claim 5 , wherein the navigation system is configured to prompt a user to update a model of the tissue when the tool-to-bone offset exceeds a predefined threshold, and wherein updating the model of the tissue comprises contacting a resected surface of the tissue with the instrument tool tip while power is disabled from the controller to the surgical instrument.

15. A surgical system configured to verify a tracking registration during a surgical operation, the surgical system comprising:

an instrument tracker coupled to a surgical instrument, the surgical instrument including a tool tip;

a patient tracker to be coupled to a patient's anatomy; and

a navigation system in communication with data representing the surgical instrument and data representing the patient's anatomy, the navigation system configured to:

track the surgical instrument and the anatomy and storing first data representing the tracked surgical instrument and second data representing the tracked anatomy in a common coordinate system;

determine the tool tip is within a predefined proximity to the tracked anatomy based on the first data representing the tracked surgical instrument and second data representing the tracked anatomy;

determine the tool tip does not depart the predefined proximity by more than a predefined magnitude over a predefined duration;

determine an offset distance based on the first data representing the tracked surgical instrument and the second data representing the tracked anatomy;

compare the offset distance to a predefined threshold; and

trigger an action when the offset distance is greater than the predefined threshold.

16. The system of claim 15 , wherein the navigation system is configured to prompt a user to verify a tracking registration by one of displaying a prompt on a display; sounding an audible alert; generating a haptic sensation; or combinations thereof.

17. The system of claim 15 , wherein determining the tool tip is within a predefined proximity to the anatomy includes determining the tool tip is within a predefined proximity to a defined surface area of the anatomy that is not to be resected.

18. The system of claim 15 , wherein the offset distance is defined as a magnitude of minimum separation between the tool tip and the tracked anatomy in the common coordinate system, or as a magnitude of greatest overlap between the tool tip and the tracked anatomy in the common coordinate system.

19. The system of claim 15 , wherein determining the tool tip is within a predefined proximity to the tracked anatomy includes the surgical instrument positioned at a first pose with respect to the tracked anatomy, and the offset distance is defined as a first offset distance corresponding to the first pose, and

wherein the navigation system is configured to determine the tool tip is within a predefined proximity to the tracked anatomy including the surgical instrument positioned at a second pose with respect to the tracked anatomy; determine a second offset distance corresponding to the second pose; and trigger an action when the first offset distance, the second offset distance, or both the first and second offset distances are greater than the predefined threshold.

20. The system of claim 19 , wherein the first pose includes a defined first proximal point of the tool tip being within the predefined proximity of the tracked anatomy; the second pose includes a defined second proximal point of the tool tip being within the predefined proximity of the tracked anatomy; the surgical instrument includes an elongated aspect terminating at the tool tip, the elongated aspect defining a longitudinal axis extending substantially parallel to the elongated aspect; and the second proximal point is at least 90° from the first proximal point relative to a rotation about the longitudinal axis.

Assignments (2)
CHANGE OF ADDRESS Recorded Dec 18, 2024
From: STRYKER CORPORATION
To: STRYKER CORPORATION
Reel/Frame 069737/0184 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 21, 2023
From: WALEN, JAMES G.; BOLTHOUSE, ZACHARY
To: STRYKER CORPORATION
Reel/Frame 064013/0257 →
Continuity (4)
Continuation 17147599 · Jan 13, 2021
Provisional Application 63054811 · Jul 22, 2020
Provisional Application 62960218 · Jan 13, 2020
Related Publication 20230293246A1 · Sep 21, 2023
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