# US 11,026,750 B2 · Real-time surgical navigation

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- Number: US 11,026,750 B2
- Document ID: US11026750B2
- Status: Granted
- Kind: B2
- Application number: 15/004,289
- Filed: 2016-01-22
- Published: 2016-08-25
- Granted: 2021-06-08
- Earliest claimed: 2015-01-23
- Assignees: Queen's University at Kingston; Kingston Health Sciences Centre
- Applicants: Queen's University at Kingston; Kingston Health Sciences Centre
- Inventors: Gabor Fichtinger; Tamas Ungi; John F. Rudan; Andras Lasso; C. Jay Engel; Gabrielle Gauvin; Caitlin Yeo
- Web page: https://patentgrep.com/patent/US11026750B2

## CPC

- A61B 34/20: Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
- A61B 5/062: {using magnetic field}
- A61B 17/320016: {Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes (A61B10/0233, A61B17/29, A61B17/3207 take precedence)}
- A61B 34/76: {Manipulators having means for providing feel, e.g. force or tactile feedback}
- A61N 5/1001: {using radiation sources introduced into or applied onto the body; brachytherapy}
- A61B 17/3403: {Needle locating or guiding means}
- A61B 2017/00115: {with audible or visual output}
- A61B 2017/00292: {mounted on or guided by flexible, e.g. catheter-like, means}
- A61B 2017/008: {Removal of tumors}
- A61B 2017/3405: {using mechanical guide means}
- A61B 2017/3413: {guided by ultrasound}
- A61B 2034/2051: {Electromagnetic tracking systems}
- A61N 5/1015: {Treatment of resected cavities created by surgery, e.g. lumpectomy}
- A61N 5/1049: {for verifying the position of the patient with respect to the radiation beam}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)

## Abstract

An apparatus and method for surgical tracking comprises an imaging device that generates an image of a tissue volume; an electromagnetic (EM) sensor that creates a reference frame for EM tracking in three dimensions; at least one EM sensor adapted to be attached to the tissue to track local deformation and movement of the tissue volume; a processor that registers the image with the EM-tracked tissue volume and surgical tool in real time, and produces an output; and a feedback device that provides feedback about the location of the surgical tool relative to the tissue volume, based on the processor output. Embodiments are particularly useful in soft tissue, such as breast, where deformation before and during a procedure such as tumor resection complicate tracking of the tissue volume and a surgical tool.

## Claims

### Claim 1

A surgical navigation method, comprising:
disposing one or more electromagnetic (EM) tracked localization devices in a tissue volume;
generating images of the tissue volume in real time using an EM tracked imaging device, wherein the images of the tissue volume are only generated intraoperatively;
using only data points in the images of the tissue volume to intraoperatively delineate a portion of the tissue volume at its current location;
disposing an EM tracked surgical tool in the tissue volume;
using EM tracking of the one or more localization devices, the imaging device, and the surgical tool to three-dimensionally visualize and register the surgical tool relative to the intraoperatively delineated portion of the tissue volume in real time; and
providing feedback about the location of the surgical tool relative to the intraoperatively delineated portion of the tissue volume.

### Claim 2 (depends on 1)

The method of claim 1, wherein EM tracking comprises:
creating a global frame of reference for EM tracking;
using at least one EM sensor attached to the tissue to track local deformation and movement of the tissue volume; and
using an EM sensor to track movement of the surgical tool.

### Claim 3 (depends on 2)

The method of claim 2, wherein creating the global frame of reference for EM tracking comprises using an EM sensor attached to the patient.

### Claim 4 (depends on 2)

The method of claim 2, wherein using at least one EM sensor to track local deformation and movement of the tissue volume comprises using an EM sensor attached to each of one or more wire-localization needles.

### Claim 5 (depends on 1)

The method of claim 1, comprising displaying and dynamically updating the three-dimensional delineation of the portion of the tissue volume as data points from the images are added or removed.

### Claim 6 (depends on 1)

The method of claim 1, wherein providing feedback comprises one or more of visual, tactile, and auditory feedback.

### Claim 7 (depends on 1)

The method of claim 1, applied to a tissue resection procedure.

### Claim 8 (depends on 1)

The method of claim 1, wherein the tissue volume comprises a tumor.

### Claim 9 (depends on 7)

The method of claim 7, wherein the resection procedure is a lumpectomy in breast tissue.

### Claim 10 (depends on 1)

The method of claim 1, applied to a brachytherapy procedure.

### Claim 11 (depends on 1)

The method of claim 1, wherein the surgical tool comprises a catheter, needle, cutting tool, cautery tool, or radiation therapy device.

### Claim 12

Apparatus for surgical navigation, comprising:
an electromagnetic (EM) device that creates a reference frame for EM tracking in three dimensions;
one or more localization devices adapted to be attached to tissue and to provide EM tracking of local deformation and movement of a tissue volume;
an EM sensor adapted to be attached to a surgical tool;
a processor that receives images of the tissue volume in real time from an EM tracked imaging device, wherein the images of the tissue volume are only generated intraoperatively, EM tracking data of the one or more localization devices, and EM tracking data of the surgical tool, intraoperatively generates a three-dimensional delineation of a portion of the tissue volume using only data points in the images of the tissue volume, and three-dimensionally registers the intraoperatively delineated portion of the tissue volume with the surgical tool in real time; and
an output device.

### Claim 13 (depends on 12)

The apparatus of claim 12, wherein the output device provides feedback about the location of the surgical tool relative to the tissue volume.

### Claim 14 (depends on 12)

The apparatus of claim 12, wherein the EM device that creates a reference frame comprises an EM sensor attached to the patient.

### Claim 15 (depends on 12)

The apparatus of claim 12, wherein the one or more localization devices adapted to be attached to the tissue comprise at least one wire-localization needle.

### Claim 16 (depends on 12)

The apparatus of claim 12, wherein the tissue volume comprises a tumor.

### Claim 17 (depends on 12)

The apparatus of claim 12, wherein the tissue comprises breast tissue.

### Claim 18 (depends on 13)

The apparatus of claim 13, wherein the feedback comprises one or more of visual, tactile, and auditory feedback.

### Claim 19 (depends on 12)

The apparatus of claim 12, wherein the surgical tool comprises a cutting tool, cautery tool, catheter, needle, or radiation therapy device.

### Claim 20

Programmed media for use with a processor, comprising:
code stored on non-transitory storage media compatible with the processor, the code containing instructions to direct the processor to:
receive images of a tissue volume in real time from an EM tracked imaging device, wherein the images of the tissue volume are only generated intraoperatively, and intraoperatively generate a three-dimensional delineation of a portion of the tissue volume using only data points in the images of the tissue volume;
receive EM tracking data of one or more EM-tracked localization devices and of an EM-tracked surgical tool, and use the EM tracking data to three-dimensionally register the intraoperatively delineated portion of the tissue volume with the EM-tracked surgical tool in real time; and
produce an output comprising feedback about the location of the EM-tracked surgical tool relative to the intraoperatively delineated portion of the tissue volume in real time.

### Claim 21 (depends on 20)

The programmed media of claim 20, wherein the output comprises images of the EM-tracked surgical tool registered in the intraoperatively delineated portion of the tissue volume in real time.