System and method for surgical instrument disablement via image-guided position feedback

• US 20050228256A1
• Filed: 03/14/2005
• Published: 10/13/2005
• Est. Priority Date: 03/22/2004
• Status: Active Grant

• Current Assignee: Vanderbilt University
• Original Assignee: Vanderbilt University
• Inventors: Fitzpatrick, J. Michael, Labadie, Robert F.
• Granted Patent: US 7,899,512 B2
• Time in Patent Office: Days
• US Class Current: 600/407
• CPC Class Codes: A61B 17/24 for use in the oral cavity, larynx, bronchial passages or nose for medical inspection of cavities or tubes in the body A61B1/00; Tongue scrapers
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00035 pH
• CPC Class Codes: A61B 2017/00057 Light
• CPC Class Codes: A61B 2017/00106 ultrasonic
• CPC Class Codes: A61B 2017/00123 and automatic shutdown
• CPC Class Codes: A61B 2017/00216 with eye tracking or head position tracking control
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2034/2055 Optical tracking systems
• CPC Class Codes: A61B 2034/2072 Reference field transducer attached to an instrument or patient
• CPC Class Codes: A61B 2090/0801 Prevention of accidental cutting or pricking
• CPC Class Codes: A61B 2090/08021 of the patient or his organs
• CPC Class Codes: A61B 2090/363 Use of fiducial points
• CPC Class Codes: A61B 2090/364 Correlation of different images or relation of image positions in respect to the body
• CPC Class Codes: A61B 2090/372 Details of monitor hardware
• CPC Class Codes: A61B 2090/374 NMR or MRI
• CPC Class Codes: A61B 2090/3954 magnetic, e.g. NMR or MRI
• CPC Class Codes: A61B 2090/3983 Reference marker arrangements for use with image guided surgery
• CPC Class Codes: A61B 2090/502 Headgear, e.g. helmet, spectacles
• 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 90/06 : Measuring instruments not otherwise provided for
• CPC Class Codes: A61B 90/10 : for stereotaxic surgery, e.g. frame-based stereotaxis
• CPC Class Codes: A61B 90/16 : Bite blocks
• CPC Class Codes: A61B 90/36 : Image-producing devices or illumination devices not otherwise provided for
• CPC Class Codes: A61B 90/39 : Markers, e.g. radio-opaque or breast lesions markers

Abstract

A system for selectively disabling a surgical instrument operating in a surgical site of a region of interest of a living subject. In one embodiment, the system includes means for noninvasively placing a number of fiducial markers in an anatomic space of the region of interest of the living subject, means for pre-operatively measuring a location of each fiducial marker in the anatomic space, an imaging acquisition device for pre-operatively acquiring an image volume from the region of interest of the living subject, a probe for intra-operatively monitoring a location of the surgical instrument in the anatomic space, and a controller configured to perform the steps of identifying a centroid of each fiducial marker in the image volume, registering the identified centroid of each fiducial marker in the image volume to the measured location of the corresponding fiducial marker in the anatomic space to determine a registration transformation, mapping the monitored location of the surgical instrument in the anatomic space onto a corresponding location in the image volume by an inverse of the registration transformation, and generating a signal to disable the surgical instrument when the mapped location of the surgical instrument is substantially close to a boundary of the surgical site of the region of interest in the image volume.

Claims

1. A system for selectively disabling a surgical instrument operating in a surgical site of a region of interest of a living subject, wherein the surgical instrument has a distal end portion, comprising:

a. means for noninvasively placing a number, M, of fiducial markers in an anatomic space of the region of interest of the living subject;

b. means for pre-operatively measuring a location of each fiducial marker in the anatomic space of the region of interest of the living subject;

c. an imaging acquisition device for pre-operatively acquiring an image volume from the region of interest of the living subject, the pre-operatively acquired image volume containing the image of at least two of M fiducial markers;

d. a probe operatively coupled with the surgical instrument for intra-operatively monitoring a location of the distal end portion of the surgical instrument in the anatomic space of the region of interest of the living subject; and

e. a controller operatively coupled with the measuring means, the imaging acquisition device, the probe, and the surgical instrument, respectively, and configured to perform the steps of;

(i). identifying a centroid of each fiducial marker in the pre-operatively acquired image volume;

(ii). registering the identified centroid of each fiducial marker in the pre-operatively acquired image volume to the pre-operatively measured location of the corresponding fiducial marker in the anatomic space so as to determine a registration transformation;

(iii). mapping the intra-operatively monitored location of the distal end portion of the surgical instrument in the anatomic space onto a corresponding location in the pre-operatively acquired image volume by an inverse of the registration transformation; and

(iv). generating a signal to disable the surgical instrument when the mapped location of the distal end portion of the surgical instrument is substantially close to a boundary of the surgical site of the region of interest in the pre-operatively acquired image volume.

2. The system of claim 1, further comprising a number, N, of surgical markers, each placed in a surgically significant anatomic location serving as a registration target.

3. The system of claim 2, wherein the region of interest of the living subject corresponds to an ear portion of the living subject.

4. The system of claim 3, wherein the placing means comprises:

a. a locking dental acrylic resin splint (LADS) mountable to a maxilla of the living subject, wherein the LADS includes a central portion with an extension at a predetermined position, and two lateral portions attached to the central portion; and

b. a fiducial frame attachable to the LADS by the extension for receiving the number M of fiducial markers, the fiducial frame being configured such that when the number M of fiducial markers are received therein, the centroid of each fiducial marker approximates the surgical site of the ear portion of the living subject and distance between at least one pair of two corresponding fiducial markers is maximized so as to minimize a target registration error.

5. The system of claim 4, wherein the fiducial frame comprises a frame structure, a first panel and an opposite, second panel extending upwardly from the frame structure, each of the first panel and the second panel defining a number of holes for receiving a corresponding number of fiducial markers.

6. The system of claim 1, further comprising an alarm device communicating with the controller for generating an alarm when the mapped location of the distal end portion of the surgical instrument is within a predetermined distance to the boundary of the surgical site in the region of interest in the pre-operatively acquired image volume.

7. The system of claim 1, further comprising an interlock device operatively associated with the surgical instrument and communicating with the controller, wherein the interlock device disables the surgical instrument when the mapped location of the distal end portion of the surgical instrument is within a predetermined distance to the boundary of the surgical site in the region of interest in the pre-operatively acquired image volume.

8. The system of claim 1, wherein the surgical instrument comprises a drill, and the distal end portion of the surgical instrument comprises the tip of the drill.

9. The system of claim 1, wherein the surgical instrument comprises a surgical scalpel, and the distal end portion of the surgical instrument comprises the cutting portion of the surgical scalpel.

10. The system of claim 1, wherein the surgical instrument comprises a section device, and the distal end portion of the surgical instrument comprising a sucking portion of the suction device.

11. A method for selectively disabling a surgical instrument operating in a surgical site of a region of interest of a living subject, wherein the surgical instrument has a distal end portion, and the region of interest of the living subject is surrounded with a plurality of markers, the plurality of markers including a number, M, of fiducial markers determining an image registration and a number, N, of surgical markers, each surgical marker placed in a surgically significant anatomic location serving as a registration target, comprising the steps of:

a. pre-operatively acquiring an image volume from the region of interest of the living subject, the pre-operatively acquired image volume containing the image of at least two of M fiducial markers;

b. identifying a centroid of each fiducial marker from the pre-operatively acquired image volume;

c. pre-operatively measuring a location of each fiducial marker in an anatomic space of the region of interest of the living subject;

d. registering the identified centroid of each fiducial marker in the pre-operatively acquired image volume to the pre-operatively measured location of the corresponding fiducial marker in the anatomic space so as to determine a registration transformation;

e. intra-operatively monitoring a location of the distal end portion of the surgical instrument in the anatomic space of the region of interest of the living subject;

f. mapping the intra-operatively monitored location of the distal end portion of the surgical instrument in the anatomic space onto a corresponding location in the pre-operatively acquired image volume by an inverse of the registration transformation; and

g. generating a signal to disable the surgical instrument when the mapped location of the distal end portion of the surgical instrument is substantially close to a boundary of the surgical site of the region of interest of the living subject in the pre-operatively acquired image volume.

12. The method of claim 11, wherein the region of interest of the living subject corresponds to an ear portion of the living subject.

13. The method of claim 12, further comprising the step of mounting an LADS with an attached fiducial frame onto a maxilla of the living subject, wherein the fiducial frame is configured such that when the number M of fiducial markers are received therein, the centroid of each fiducial marker approximates the surgical site of the ear portion of the living subject and distance between at least one pair of two corresponding fiducial markers is maximized so as to minimize a target registration error.

14. The method of claim 11, further comprising the step of generating an alarm when the mapped location of the surgical instrument is within a predetermined distance to the boundary of the surgical site in the pre-operatively acquired image volume.

15. A system for selectively disabling a surgical instrument operating in a surgical site of a region of interest of a living subject, wherein the surgical instrument has a distal end portion and is operable by a surgeon during a surgery, comprising:

a. an eye-tracking device operatively coupled with the surgical instrument for intra-operatively tracking the visual line of sight of the surgeon and a location of the distal end portion of the surgical instrument in the region of interest of the living subject, respectively; and

b. a controller operatively coupled with the surgical instrument and the eye-tracking device, respectively, and configured to perform during the surgery the steps of;

(i). determining an angle between a visual path connecting a predetermined point of the eye-tracking device and the distal end portion of the surgical instrument in the region of interest of the living subject and the line of sight of the surgeon; and

(ii). generating a signal to disable the surgical instrument when the angle is larger than a predetermined angle.

16. The system of claim 15, further comprising a display communicating with the controller and the eye-tracking device for displaying the tracked line of sight of the surgeon and the tracked location of the distal end portion of the surgical instrument in the region of interest of the living subject, respectively.

17. The system of claim 15, wherein the eye-tracking device comprises a sensor.

18. The system of claim 15, wherein the eye-tracking device comprises a head-hold device.

19. A method for selectively disabling a surgical instrument operating in a surgical site of a region of interest of a living subject, wherein the surgical instrument has a distal end portion and is operable by a surgeon during a surgery, comprising the steps of:

a. intra-operatively tracking the visual line of sight of the surgeon and a location of the distal end portion of the surgical instrument in the region of interest of the living subject, respectively;

b. determining an angle between a visual path connecting a predetermined point of the eye-tracking device and the distal end portion of the surgical instrument in the region of interest of the living subject and the line of sight of the surgeon; and

c. generating a signal to disable the surgical instrument when the angle is larger than a predetermined angle.

20. A system for selectively disabling a surgical instrument operating in a surgical site of a region of interest of a living subject, wherein the surgical instrument has a distal end portion and is operable by a surgeon during a surgery, comprising:

a. a probe for intra-operatively monitoring an electrophysiological condition of the living subject in the region of interest; and

b. a controller operatively coupled with the surgical instrument and the probe, respectively, and configured to perform during the surgery the steps of;

(i). determining a variation of the electrophysiological condition of the living subject from an initial state of the living subject in the region of interest; and

(ii). generating a signal to disable the surgical instrument when the variation of the electrophysiological condition is greater then a predetermined value.

21. The system of claim 20, further comprising at least one of a display and an audio device for visually and/or audibly displaying the intra-operatively monitored electrophysiological condition of the living subject in the region of interest, respectively.

22. The system of claim 20, wherein the probe comprises at least one needle electrode placed in the region of interest of the living subject.

23. The system of claim 22, wherein the electrophysiological condition comprises an electromyogram of electrical activities of muscles of the region of interest of the living subject.

24. The system of claim 20, wherein the probe comprises a Doppler vascular probe.

25. The system of claim 24, wherein the electrophysiological condition comprises a flow rate of blood vessels of the region of interest of the living subject.

26. The system of claim 20, wherein the probe comprises a temperature-sensing device.

27. The system of claim 26, wherein the electrophysiological condition comprises a temperature of tissues of the region of interest of the living subject.

28. The system of claim 20, wherein the probe comprises an oxygenation detector.

29. The system of claim 28, wherein the electrophysiological condition comprises a venous oxygenation saturation and an arterial oxygenation saturation of the region of interest of the living subject.

30. The system of claim 20, wherein the probe comprises a tissue boundary detector.

31. The system of claim 30, wherein the tissue boundary detector comprises at least one of an ultrasound sensing device, an infrared radiation sensing device, an ultraviolet radiation sensing device, a fluorescent radiation sensing device, and a video frame device.

32. The system of claim 31, wherein the electrophysiological condition comprises a tissue type identification of tissues at the distal end portion of the surgical instrument in the region of interest of the living subject.

33. The system of claim 32, wherein the electrophysiological condition comprises a volume of suction from the region of interest of the living subject.

34. A method for selectively disabling a surgical instrument operating in a surgical site of a region of interest of a living subject, wherein the surgical instrument has a distal end portion and is operable by a surgeon during a surgery, comprising the steps of:

a. intra-operatively monitoring the electrophysiological condition of the living subject in the region of interest;

b. determining a variation of the electrophysiological condition of the living subject from an initial state of the living subject in the region of interest; and

c. generating a signal to disable the surgical instrument when the variation of the electrophysiological condition is greater than a predetermined value.

35. The method of claim 34, wherein the electrophysiological condition comprises an electromyogram of electrical activities of muscles of the region of interest of the living subject.

36. The method of claim 34, wherein the electrophysiological condition comprises a flow rate of blood vessels of the region of interest of the living subject.

37. The method of claim 34, wherein the electrophysiological condition comprises a temperature of tissues of the region of interest of the living subject.

38. The method of claim 34, wherein the electrophysiological condition comprises a venous oxygenation saturation and an arterial oxygenation saturation of the region of interest of the living subject.

39. The method of claim 34, wherein the electrophysiological condition comprises a tissue type identification of tissues at the distal end portion of the surgical instrument in the region of interest of the living subject.

40. The method of claim 34, wherein the electrophysiological condition comprises a volume of suction from the region of interest of the living subject.