SURGICAL LOCATION MONITORING SYSTEM AND METHOD USING SKIN APPLIED FIDUCIAL REFERENCE

• US 20130131505A1
• Filed: 01/19/2013
• Published: 05/23/2013
• Est. Priority Date: 10/28/2011
• Status: Abandoned Application

• Current Assignee: Navigate Surgical Technologies, Inc.
• Original Assignee: Navident Technologies, Inc.
• Inventors: Daon, Ehud (Udi), Beckett, Martin Gregory
• Application Number:
  US13/745,763
• Publication Number:
  US 20130131505A1
• Time in Patent Office: Days
• US Class Current: 600/426
• CPC Class Codes: A61B 1/00 Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes examination of body cavities or body tracts using ultrasonic, sonic or infrasonic waves A61B8/12; endoscopic instruments for taking cell samples or for biopsy A61B10/04; for surgical purposes A61B17/00; endoscopic surgical cutting instruments A61B17/32; surgical instruments using a laser beam being directed along or through a flexible conduit A61B18/22; Illuminating arrangements therefor for the eyes A61B3/00
• CPC Class Codes: A61B 10/0233 Pointed or sharp biopsy instruments
• CPC Class Codes: A61B 2034/2065 Tracking using image or pattern recognition
• CPC Class Codes: A61B 2090/395 with marking agent for marking skin or other tissue
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 2090/3983 Reference marker arrangements for use with image guided surgery
• 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 6/02 Arrangements for diagnosis sequentially in different planes; Stereoscopic radiation diagnosis
• CPC Class Codes: A61B 6/032 Transmission computed tomography [CT]
• CPC Class Codes: A61B 6/12 Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61B 6/481 involving the use of contrast agents
• CPC Class Codes: A61B 6/51 for dentistry
• CPC Class Codes: A61B 6/512 Intraoral means
• CPC Class Codes: A61C 1/082 Positioning or guiding, e.g. of drills
• CPC Class Codes: A61C 3/02 Tooth drilling or cutting instruments; Instruments acting like a sandblast machine
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 30/20 for handling medical images, e.g. DICOM, HL7 or PACS

Abstract

The present invention involves a surgical monitoring system and method for modeling surgical procedures. A multi-element fiducial reference pattern observable by a tracker may be transferred directly to the skin proximate the surgical site, either through a stencil as a radio-opaque ink pattern or via transfer tape, or may be applied in prepared form on a surgical incise film. Alternatively the surgical incise film may be applied over the surgical site and the inked reference pattern applied to the film before surgery. A controller determines the three-dimensional location and orientation of the surgical site by comparing the position and orientation of the reference pattern in a prior scan with the position and orientation of the reference pattern in image information about the surgical site obtained from the tracker. The system may track the movement of instruments relative to the surgical site, or may be used to track changes in the surgical site itself.

Claims

1. A surgical monitoring system comprising:

a fiducial reference including a radio-opaque marking having skin adhesion property such that the radio-opaque marking adheres to a location on skin proximate a surgical site;

a tracker arranged for obtaining the image information; and

a computer system having a scan of the patient with the fiducial reference fixed to the skin of surgical patient, said computer system in communication with said tracker and including a processor with memory and a software program having a series of instructions when executed by the processor determines the relative position and orientation of the fiducial reference based on information from said tracker, and relates the current arrangement of the fiducial reference in relation to the scan data.

2. The surgical monitoring system of claim 1 wherein the fiducial reference includes a plurality of pattern segments, each segment being configured for having a segmental three-dimensional location and orientation determinable based on scan data of the surgical site, and for having the segmental three-dimensional location and orientation determinable based on image information about the surgical site.

3. The surgical monitoring system of claim 2 wherein the plurality of pattern segments is borne on surgical incise film configured for application to the skin.

4. The surgical monitoring system of claim 3 wherein the plurality of pattern segments comprise one of radio-opaque ink and radio-opaque paint.

5. The surgical monitoring system of claim 2 wherein the plurality of pattern segments is configured to be transferable directly to the skin.

6. The surgical monitoring system of claim 5 wherein the plurality of pattern segments is configured to be transferable from a transfer film to the skin.

7. The surgical monitoring system of claim 5 wherein the plurality of pattern segments involves one of a radio-opaque ink pattern and a radio-opaque paint pattern applied directly to the skin.

8. The surgical monitoring system of claim 2 wherein at least one of the plurality of pattern segments has a unique differentiable shape that allows the controller to identify them uniquely from at least one of the scan data and the image information.

9. The surgical monitoring system of claim 2 wherein the controller is configured for determining the locations and orientations of at least a selection of the pattern segments based on the image information and the scan data.

10. The surgical monitoring system of claim 9 wherein the controller is configured to calculate the locations of anatomical features in the proximity of the plurality of pattern segments.

11. The surgical monitoring system of claim 10 further comprising at least one tracking marker attached to implements proximate the surgery site, wherein the controller is configured for determining locations and orientations of the implements based on the image information and information about the tracking marker.

12. The surgical monitoring system of claim 1 comprising a plurality of tracking markers attached to implements proximate the surgery site, and wherein the controller is configured for determining locations and orientations of the implements based on the image information and information about the further tracking markers.

13. The surgical monitoring system of claim 1 wherein the fiducial reference comprises a plurality of elements configured in a spatially arbitrary arrangement.

14. The surgical monitoring system of claim 13 wherein the plurality of elements includes one of a plurality radio-opaque ink dots and a plurality of radio-opaque paint dots.

15. A method for relating in real time three-dimensional location and orientation of a surgical site to a location and orientation of the surgical site in a scan of the surgical site, the method comprising the steps of:

applying a fiducial reference in the form of a radio-opaque marker on skin proximate the surgical site;

performing the scan to obtain scan data;

determining three-dimensional location and orientation of the fiducial reference from the scan data;

obtaining real time image information of the surgical site;

determining in real time three-dimensional location and orientation information of the fiducial reference from the image information; and

deriving a spatial transformation matrix for expressing in real time the three-dimensional location and orientation of the fiducial reference as determined from the image information in terms of the three-dimensional location and orientation of the fiducial reference as determined from the scan data.

16. The method of claim 15 wherein the fiducial reference includes a plurality of pattern segments individually locatable based on the scan data;

the step of determining the three-dimensional location and orientation of the fiducial reference from the scan data comprises determining the three-dimensional location and orientation of at least one of the plurality of pattern segments from the scan data; and

the step of determining in real time the three-dimensional location and orientation of the fiducial reference from the image information comprises determining the three-dimensional location and orientation of the at least one of the plurality of pattern segments from the image information.

17. The method of claim 16 wherein the step of applying the fiducial reference to the skin proximate the surgical site comprises applying a surgical incise film bearing the fiducial reference.

18. The method of claim 16 wherein the step of applying the fiducial reference on the skin proximate the surgical site comprises:

applying a surgical incise film to the skin over the surgical site; and

applying the fiducial reference pattern to the surgical incise film proximate the surgical site before surgery.

19. The method of claim 16 wherein the step of applying a fiducial reference on the skin proximate the surgical site comprises applying one of radio-opaque ink and radio-opaque paint directly to the skin proximate the surgical site.

20. The method of claim 19 wherein the step of applying the fiducial reference comprises transferring the plurality of pattern segments from a transfer tape.

21. The method of claim 19 wherein the step of applying the plurality of pattern segments comprises applying one of radio-opaque ink and radio-opaque paint directly to the skin using one of a mask and a stencil bearing the plurality of pattern segments.

22. A method for tracking in real time changes in a surgical site, the method comprising the steps of:

applying a multi-element fiducial reference to skin proximate the surgical site, the multi-element fiducial reference comprising a plurality of pattern segments individually locatable based on scan data;

performing a scan of the surgical site to obtain the scan data;

determining three-dimensional locations and orientations of at least a selection of the pattern segments based on the scan data;

obtaining real time image information of the surgical site;

determining in real time three-dimensional locations and orientations of the at least one of the pattern segments from the image information; and

deriving in real time the spatial distortion of the surgical site by comparing in real time the three-dimensional locations and orientations of the at least one of the pattern segments as determined from the image information with the three-dimensional locations and orientations of the at least one of the pattern segments as determined from the scan data.

23. The method of claim 22 wherein the step of applying the fiducial reference on the skin proximate the surgical site comprises applying a surgical incise film bearing the plurality of pattern segments.

24. The method of claim 22 wherein the step of applying the fiducial reference on the skin proximate the surgical site comprises:

applying a surgical incise film to the skin over the surgical site; and

transferring the plurality of pattern segments to the surgical incise film proximate the surgical site before surgery.

25. The method of claim 22 wherein the step of applying the fiducial reference on the skin proximate the surgical site comprises applying the plurality of pattern segments in the form of one of radio-opaque ink and radio-opaque paint directly to the skin proximate the surgical site.

26. The method of claim 25 wherein the step of applying the fiducial reference comprises transferring the plurality of pattern segments from a transfer tape.

27. The method of claim 25 wherein the step of applying the plurality of pattern segments comprises applying one of radio-opaque ink and radio-opaque paint directly to the skin using one of a mask and a stencil bearing the plurality of pattern segments.

28. A method for real time monitoring three-dimensional location and orientation of an object in relation to a surgical site of a patient, the method comprising:

applying a fiducial reference on the skin proximate the surgical site;

performing a scan of the surgical site to obtain scan data;

determining three-dimensional location and orientation of the fiducial reference from the scan data;

obtaining real time image information of the surgical site;

determining in real time three-dimensional location and orientation of the fiducial reference from the image information;

deriving a spatial transformation matrix for expressing in real time the three-dimensional location and orientation of the fiducial reference as determined from the image information in terms of the three-dimensional location and orientation of the fiducial reference as determined from the scan data;

determining in real time three-dimensional location and orientation of the object from the image information; and

relating the three-dimensional location and orientation of the object to the three-dimensional location and orientation of the fiducial reference as determined from the image information.

29. The method of claim 28 wherein the step of determining in real time the three-dimensional location and orientation of the object from the image information comprises attaching to the object a tracking marker.

30. A method for determining the position and orientation of a tracker with respect to a surgical site, the method comprising the steps of:

applying proximate the surgical site an arbitrarily arranged a plurality of non-unique elements, each element including one of radio-opaque ink and radio-opaque paint, at least a portion of said plurality of elements defining a constellation;

obtaining scan data of the surgical site;

obtaining image information about the surgical site from a tracker;

determining a position and orientation of at least one of the plurality of elements in the scan data;

determining a position and orientation of the constellation in the image information;

deriving a three-dimensional transformation matrix to relate the multi-element fiducial pattern to a coordinate system of the surgical site based on the position and orientation of the constellation in the scan data and the position and orientation of the constellation in the image information; and

determining the position and orientation of a tracker with respect to the surgical site.

31. The method of claim 30 wherein the step of applying the fiducial pattern includes depositing one of a radio-opaque ink and a radio-opaque paint in an arbitrary arrangement of elements.

32. The method of claim 31 wherein the step of depositing comprises applying a surgical incise film to the skin over the surgical site;

and depositing the one of radio-opaque ink and radio-opaque paint on the surgical incise film.