Detection of unintentional movement of a reference marker and automatic re-registration

{
  "publication_number": "US12279834B2",
  "country": "US",
  "kind": "B2",
  "title": "Detection of unintentional movement of a reference marker and automatic re-registration",
  "abstract": "Described herein is the automatic re-registration of a bumped reference marker, where the navigation system includes the reference marker, a bump detection sensor(s), and a computing device. The computing device can store positional relationships between the reference marker, the bump detection sensor(s), and the anatomy from an initial image registration and receive position data of the reference marker and bump detection sensor(s) at times during use. The computing device can determine a delta matrix based on the stored and received information and then determine if the reference marker has been bumped. If the reference marker has been bumped the computing device can determine if automatic re-registration is required and complete the automatic re-registration if needed to correct for the bump.",
  "claims": [
    "1. A navigation system comprising: a reference marker detectable by an image acquisition device and configured to be positioned on a portion of a patient's anatomy; at least one bump detection sensor having a lower profile than the reference marker, wherein the reference marker, the at least one bump detection sensor, and the portion of the patient's anatomy are image registered at an initial image registration time; a computing device comprising: a memory storing instructions and data, including a static relationship between a position of the at least one bump detection senserand a position of the reference marker at the initial image registration time and a static relationship between the position of the reference marker and a position of the portion of the patient's anatomy at the initial image registration time; and a processor configured to access the memory to execute the instructions to at least: receive position data of an actual position of the reference marker at a time; receive position data of an actual position of each of the at least one bump detection sensor at the time; determine a delta matrix based on the position data of the actual position of the reference marker at the time, the position data of the actual position of each of the at least one bump detect sensor at the time, and the static relationship between the positions of the at least one bump detection senser and the reference marker at the initial image registration time; determine the shift in the actual position of the reference marker relative to the position of the anatomy at the time based on the delta matrix and the static relationship between the positions of the reference marker and the portion of the patient's anatomy at the initial image registration time; and determine whether automatic re-registration is required based on one or more predefined thresholds.",
    "2. The navigation system of claim 1, wherein the instruction to determine whether the automatic re-registration is required based on the one or more predefined thresholds further comprises: when the shift in the actual position of the reference marker relative to the position of the portion of the patient's anatomy at the time is less than a first predefined threshold, then do not re-register the reference marker with the anatomy; when the shift in the actual position of the reference marker relative to the position of the portion of the patient's anatomy at the time is between the first predefined threshold and a second predefined threshold, then: calculate a corrected relationship between a new, shifted position of the reference marker and the portion of the patient's anatomy, and automatically re-register the reference marker with the portion of the patient's anatomy; and when the shift in the actual position of the reference marker relative to the position of the portion of the patient's anatomy is greater than the second predefined threshold, then: output a message asking if the navigation system should re-register the reference marker with the portion of the patient's anatomy, and if receive confirmation, then calculate the corrected relationship between the new, shifted position of the reference marker and the portion of the patient's anatomy, and re-register the reference marker with the portion of the patient's anatomy.",
    "3. The navigation system of claim 1, wherein the portion of the patient's anatomy is a rigid body and one of the at least one bump detection sensors is configured to be positioned on the rigid body adjacent to the reference marker.",
    "4. The navigation system of claim 3, wherein at least a second bump detection sensor is configured to be positioned on a different rigid body than the reference marker.",
    "5. The navigation system of claim 1, wherein the reference marker is configured to be positioned on a spinal process of the patient above an area of the spine being worked on by a user of the system; and wherein the at least one bump detection sensor is configured to be positioned on the spinal process of the patient.",
    "6. The navigation system of claim 1, wherein the system further comprises a stereotactic surgical robot, and wherein the processor further comprises instructions to: provide a trajectory to an end effector of the stereotactic surgical robot, relative to a procedure; and modify the trajectory based on the automatic re-registration.",
    "7. The navigation system of claim 1, wherein the system further comprises an output device configured for image guided surgery and displaying at least one view of at least one of the portion of the patient's anatomy, the reference marker, and the at least one bump detection sensor.",
    "8. The navigation system of claim 1, wherein the at least one bump detection sensor is an optical sensor, an accelerometer, a gyroscope, a magnetometer, a potentiometer, a Hall effect sensor, a linear variable displacement transducer, a strain gage, an ultrasonic sensor, an electromagnetic sensor, and/or a laser distance measurement sensor.",
    "9. The navigation system of claim 1, wherein the at least one bump detection sensor comprises a first bump detection sensor configured to be positioned on the portion of the patient's anatomy and at least a second bump detection sensor configured to be positioned on at least one of: a surgical table the patient is located on, an end effector of a stereotactic surgical robot working on the patient, or another portion of the patient's anatomy.",
    "10. The navigation system of claim 9, wherein the at least the second bump detection sensor is configured to detect robotic compliance and/or a robot positioning error in a robot associated with the navigation system.",
    "11. The navigation system of claim 1, further comprising a surgical tool, wherein the automatic re-registration is based on the proximity of the surgical tool to the reference marker and the at least one bump detection sensor."
  ],
  "description_excerpt": "The present disclosure relates generally to an intraoperative navigation system for and, more specifically, to systems and methods for intraoperative navigation that can detect unintentional movement of a reference marker and automatic re-registration of the reference marker.\n\nCurrent intraoperative navigation and image guided surgery systems for spinal surgery require a reference marker to be placed on the patient's spine and a CT scan to be taken of the patient to register the anatomy with the reference marker. In this way, the surgeon/surgical team can know where their tools are with respect to the anatomy at all times and ensure holes and cuts are properly placed while avoiding sensitive structures such as the spinal cord and roots. Other surgical procedures utilize reference markers in similar ways. Unfortunately, the reference marker can be accidentally bumped or otherwise unintentionally moved throughout the surgical procedure. With current spine navigation systems, if the reference marker is bumped and the bump is noticed by the surgeon/surgical team or other personnel, then another CT scan must be performed to reregister the marker to the anatomy, exposing the patient, and often at least a portion of the surgical team as well, to additional radiation, as well as prolonging the operative time. Moreover, if the reference marker is bumped and moved without being detected, the surgeon/surgical team may proceed with the surgical procedure, potentially causing surgical complications and negatively impacting patient outcomes.",
  "cpc": [
    "A61B 34/20",
    "A61B 2017/00119",
    "A61B 2034/2048",
    "A61B 2034/2055",
    "A61B 2034/302",
    "A61B 2090/036",
    "A61B 2090/3983",
    "A61B 34/30",
    "A61B 34/32",
    "A61B 90/03",
    "A61B 90/39",
    "B25J 9/1664",
    "B25J 9/1689"
  ],
  "ipc": [
    "A61B 34/20",
    "A61B 34/30",
    "A61B 34/32",
    "A61B 90/00",
    "B25J 9/16"
  ],
  "assignees": [
    "CLEVELAND CLINIC FOUND"
  ],
  "inventors": [
    "COLBRUNN ROBB",
    "GILLESPIE CALLAN",
    "GOLUBOVSKY JOSHUA"
  ],
  "filing_date": "2023-02-08",
  "publication_date": "2025-04-22",
  "grant_date": "2025-04-22",
  "priority_date": "2022-02-08",
  "application_number": "US-202318107349-A",
  "family_id": "87522029",
  "citations": [
    "US10512508B2",
    "US2016022374A1",
    "US2019337258A1"
  ]
}