# US 11,026,752 B2 · System and method for performing and evaluating a procedure

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- Number: US 11,026,752 B2
- Document ID: US11026752B2
- Status: Granted
- Kind: B2
- Application number: 15/997,444
- Filed: 2018-06-04
- Published: 2019-12-05
- Granted: 2021-06-08
- Earliest claimed: 2018-06-04
- Assignees: Medtronic Navigation, Inc.
- Applicants: Medtronic Navigation, Inc.
- Inventors: Robert J. Reddy; John B. Clayton
- Web page: https://patentgrep.com/patent/US11026752B2

## CPC

- A61B 34/20: Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
- A61B 34/10: Computer-aided planning, simulation or modelling of surgical operations
- A61B 34/25: {User interfaces for surgical systems}
- A61B 90/37: {Surgical systems with images on a monitor during operation}
- A61B 34/30: Surgical robots
- A61B 34/76: {Manipulators having means for providing feel, e.g. force or tactile feedback}
- A61B 2017/00115: {with audible or visual output}
- A61B 2017/00119: {alarm; indicating an abnormal situation}
- A61B 2017/00128: {related to intensity or progress of surgical action}
- A61B 2034/2051: {Electromagnetic tracking systems}
- A61B 2034/2055: {Optical tracking systems}
- A61B 2034/2063: {Acoustic tracking systems, e.g. using ultrasound}
- A61B 2034/2074: {Interface software}
- A61B 2034/254: {being adapted depending on the stage of the surgical procedure}
- A61B 2090/3762: {using computed tomography systems [CT]}
- A61F 2/442: {Intervertebral or spinal discs, e.g. resilient (non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455)}
- A61F 2/4455: {for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages (intervertebral discs A61F2/442)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)

## Abstract

Disclosed is a method and system for performing a procedure. The system may include a navigation system and/or a surgical robot to be used to at least assist in the procedure. The system may assist in delineating objects and/or determining physical characteristics of subject portions. The system may assist in performing and/or a workflow of the procedure.

## Claims

### Claim 1

A method of performing a procedure on a subject, comprising:
determining a working volume in which a working end of an instrument is to operate;
saving the determined working volume; and
operating a navigation system to:
track a position of the working end;
determine the position of the working end relative to an edge of the working volume; and
output a representation to a user of the determined position of the working end relative to the edge of the working volume including at least one of a “planned working position” or a “not planned working position”;
wherein the representation to the user is operable to change based on the determined position of the working end relative to at least one of a “planned working position” or a “not planned working position”;
wherein the representation includes a first representation and a second representation;
wherein the first representation and the second representation are at a single indication position on a display device;
wherein the single indication position includes at least one of a horizontal bar or a vertical bar;
wherein the second representation includes the bar of a greater length than the first representation.

### Claim 2 (depends on 1)

The method of claim 1, wherein operating the navigation system to output the representation to the user of the determined position of the working end relative to the edge of the working volume further includes at least a gradual indication change of the representation of tracked positions of the working end between the at least “planned working position” or the “not planned working position”;
wherein the gradual indication change of the representation includes the change being gradual from the first representation to the second representation.

### Claim 3 (depends on 2)

The method of claim 2, wherein operating the navigation system to output the representation to the user of the determined position of the working end relative to the edge of the working volume further includes:
displaying an image of the subject with the display device;
displaying a graphical representation of the position of the working end displayed on the display device relative to the image of the subject.

### Claim 4 (depends on 3)

The method of claim 3, wherein displaying the graphical representation of the position of the working end includes displaying a change in color of the working volume based on the determined position of the working end relative to the edge of the working volume.

### Claim 5 (depends on 4)

The method of claim 4, wherein operating the navigation system to output the representation to the user of the determined position of the working end further includes:
recall a predetermined boundary distance relative to the edge of the working volume;
output the representation to the user as a display of a first color overlaying at least a portion of the working volume or a first audible alert; and
wherein the output is operable to change based on the determined position of the working end relative to the recalled predetermined boundary.

### Claim 6 (depends on 4)

The method of claim 4, wherein operating the navigation system to output the representation to the user of the determined position of the working end further includes:
recall a predetermined boundary distance relative to the edge of the working volume;
wherein the output of the representation to the user is a display of a first color or opacity at a first selected position relative to the image and the output of the representation is operable to change to at least a second color or opacity at a second selected position relative to the image.

### Claim 7 (depends on 1)

The method of claim 1, further comprising:
determining a boundary around the working volume;
saving the boundary;
operating the navigation system to further:
recall the saved boundary;
output the representation to the user of the determined position of the working end relative to the recalled boundary.

### Claim 8 (depends on 1)

The method of claim 1, wherein determining the working volume includes at least one of determining at least one portion of the subject to be contacted with the working end or determining at least one portion of the subject to not be contacted with the working end.

### Claim 9 (depends on 1)

The method of claim 1, further comprising:
allowing operation of the working end of the instrument when the output representation to the user of the determined position of the working end relative to the edge of the working volume is the “planned working position”.

### Claim 10 (depends on 1)

The method of claim 1, further comprising:
ceasing operation of the working end of the instrument when the output representation to the user of the determined position of the working end relative to the edge of the working volume is the “not planned working position”.

### Claim 11

A method of operating a navigation system for performing a procedure on a subject, comprising:
recalling a working volume within which a working end of an instrument is selected to travel;
recalling a non-working volume within which the working end of the instrument is not to travel
tracking a position of the working end;
determining the position of the working end relative to at least one of the working volume or non-working volume; and
displaying with a display device (i) a first representation to a user of the determined position of the working end relative to at least one of the working volume or non-working volume or (ii) a second representation to the user of the determined position of the working end relative to at least one of the working volume or non-working volume;
wherein the first representation and the second representation are both graphical representations displayed with the display device;
wherein the first representation and the second representation are at a single indication position on the display device that changes from the first representation to the second representation;
wherein the single indication position includes at least one of a horizontal bar or a vertical bar;
wherein the second representation includes the bar of a greater length than the first representation.

### Claim 12 (depends on 11)

The method of claim 11, wherein the single indication position gradually changes from the first representation to the second representation.

### Claim 13 (depends on 12)

The method of claim 12, wherein the first representation includes a first color and the second representation includes a second color;
wherein the first representation may further include a first audible alert and the second representation may further include a second audible alert.

### Claim 14 (depends on 11)

The method of claim 11, further comprising:
moving the working end relative to at least one of the working volume or non-working volume; and
changing the displayed first representation to the second representation based upon the determined position of the working end relative to at least one of the working volume or non-working volume.

### Claim 15

A method of operating a navigation system for performing a procedure on a subject, comprising:
recalling a working volume within which a working end of an instrument is selected to travel;
recalling a non-working volume within which the working end of the instrument is not to travel
tracking a position of the working end;
determining the position of the working end relative to at least one of the working volume or non-working volume; and
displaying with a display device at least one of (i) a first representation to a user of the determined position of the working end relative to at least one of the working volume or non-working volume or (ii) a second representation to the user of the determined position of the working end relative to at least one of the working volume or non-working volume;
wherein the first representation and the second representation are at a single indication position on the display device and the indication position changes from the first representation to the second representation;
wherein the single indication position gradually changes from the first representation to the second representation;
wherein the single indication position includes at least one of a horizontal bar or a vertical bar;
wherein the second representation includes the bar of a greater length than the first representation.

### Claim 16

A method of operating a navigation system for performing a procedure on a subject, comprising:
recalling a working volume within which a working end of an instrument is selected to travel;
recalling a non-working volume within which the working end of the instrument is not to travel
tracking a position of the working end;
determining the position of the working end relative to at least one of the working volume or non-working volume;
displaying with a display device at least one of (i) a first representation to a user of the determined position of the working end relative to at least one of the working volume or non-working volume or (ii) a second representation to the user of the determined position of the working end relative to at least one of the working volume or non-working volume; and
displaying an image of the subject;
wherein the first representation and the second representation are at a single indication position on the display device and the indication position changes from the first representation to the second representation;
wherein the single indication position gradually changes from the first representation to the second representation;
wherein the first representation is a first color of a portion of the displayed image of the subject and the second representation is a second color of the portion of the subject.

### Claim 17

A method of operating a navigation system for performing a procedure on a subject, comprising:
recalling a working volume within which a working end of an instrument is selected to travel;
recalling a non-working volume within which the working end of the instrument is not to travel
tracking a position of the working end;
determining the position of the working end relative to at least one of the working volume or non-working volume; and
providing a first indication to a user when the determined position of the working end is at a first position or providing a second indication to the user when the determined position of the working end is at a second position and changing from the first indication to the user to the second indication to the user as the determined position of the working end changes from the first position to the second position and vice versa;
wherein the first indication and the second indication are at a single indication position on a display device;
wherein the single indication position includes at least one of a horizontal bar or a vertical bar;
wherein the second indication includes the bar of a greater length than the first representation.

### Claim 18 (depends on 17)

The method of claim 17, wherein providing the first indication to the user or providing the second indication to the user includes:
displaying with the display device at least one of (i) a first representation to a user of the determined position of the working end relative to at least one of the working volume or non-working volume or (ii) a second representation to the user of the determined position of the working end relative to at least one of the working volume or non-working volume.

### Claim 19 (depends on 17)

The method of claim 17, wherein providing the first indication to the user or providing the second indication to the user further includes:
providing at least one of (i) a first audible sound to the user regarding the determined second position of the working end relative to at least one of the working volume or non-working volume or (ii) a second audible sound to the user regarding the determined second position of the working end relative to at least one of the working volume or non-working volume.

### Claim 20 (depends on 17)

The method of claim 17, wherein providing the first indication to the user or providing the second indication to the user the includes:
providing at least one of (i) a first haptic and/or force feedback to the user regarding the determined first position of the working end relative to at least one of the working volume or non-working volume or (ii) a second haptic and/or force feedback to the user regarding the determined second position of the working end relative to at least one of the working volume or non-working volume.

### Claim 21 (depends on 17)

The method of claim 17, wherein the changing from the first indication to the user to the second indication to the user and vice versa is gradual.