# US 12,178,515 B2 · Systems and methods for density calibration

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 12,178,515 B2
- Document ID: US12178515B2
- Status: Granted
- Kind: B2
- Application number: 17/691,364
- Filed: 2022-03-10
- Published: 2022-10-27
- Granted: 2024-12-31
- Earliest claimed: 2021-04-26
- Assignees: Arthrex, Inc.
- Applicants: Arthrex, Inc.
- Inventors: Nick Metcalfe; Robert Fergan; David Knopf
- Web page: https://patentgrep.com/patent/US12178515B2

## CPC

- A61B 34/10: Computer-aided planning, simulation or modelling of surgical operations
- G16H 40/40: for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
- A61B 6/032: {Transmission computed tomography [CT]}
- A61B 6/405: {Source units specially adapted to modify characteristics of the beam during the data acquisition process (A61B6/4021, A61B6/4035 take precedence)}
- A61B 6/463: {characterised by displaying multiple images or images and diagnostic data on one display}
- A61B 6/505: {for diagnosis of bone}
- A61B 6/563: {involving image data transmission via a network}
- A61B 6/566: {involving communication between diagnostic systems}
- A61B 6/583: {using calibration phantoms}
- A61B 34/25: {User interfaces for surgical systems}
- G16H 20/40: relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
- G16H 30/20: for handling medical images, e.g. DICOM, HL7 or PACS
- G16H 30/40: for processing medical images, e.g. editing
- G16H 40/63: for local operation
- G16H 40/67: for remote operation
- A61B 2017/00712: {simulating mathematical properties, e.g. for testing of positioning in the isocentre or focus}
- A61B 2017/00725: {Calibration or performance testing}
- A61B 2034/102: {Modelling of surgical devices, implants or prosthesis}
- A61B 2034/105: {Modelling of the patient, e.g. for ligaments or bones}
- A61B 2034/108: {Computer aided selection or customisation of medical implants or cutting guides}
- A61B 2034/256: {having a database of accessory information, e.g. including context sensitive help or scientific articles}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

This disclosure relates to planning systems and methods. The planning systems and methods disclosed herein may be utilized for planning orthopaedic procedures to restore functionality to a joint, and may include one or more calibration objects for calibrating images of patient anatomy.

## Claims

### Claim 1

A system for calibrating images of anatomy comprising:
a calibration object including a plurality of density members formed with a main body, wherein a volume of each of the density members and the main body corresponds to a respective predetermined radiodensity value; and
an imaging system comprising:
a computing device including a processor coupled to memory, wherein the processor is configured to execute a planning environment including a data module, a display module and a comparison module;
wherein the data module is configured to receive data corresponding to at least one image of a patient anatomy together with the calibration object from an imaging device;
wherein the comparison module is configured to determine one or more image gradients, each of the one or more image gradients based on a comparison of a pixel value at a respective position in the at least one image and a pixel value at one or more respective positions along the density members in the at least one image;
wherein the comparison module is configured to assign a radiodensity value to one or more positions in the at least one image based upon a comparison of the respective one or more image gradients and each respective predetermined radiodensity value; and
wherein the display module is configured to display in a graphical user interface the at least one image and a visual gradient superimposed on the one or more positions according to the assigned radiodensity values, wherein the visual gradient is defined by the predetermined radiodensity values associated with the density members.

### Claim 2 (depends on 1)

The system as recited in claim 1, wherein the at least one image is an X-ray image.

### Claim 3 (depends on 2)

The system as recited in claim 2, wherein the imaging device is a computerized tomography (CT) machine.

### Claim 4 (depends on 1)

The system as recited in claim 1, wherein the visual gradient is a color gradient in which respective color values are assigned with respect to the predetermined radiodensity values of the density members.

### Claim 5 (depends on 1)

The system as recited in claim 1, wherein:
wherein the display module is configured to display in the graphical user interface a histogram graph comprising a frequency of the assigned radiodensity values corresponding to at least a subset of the one or more positions in the at least one image.

### Claim 6 (depends on 1)

The system as recited in claim 1, wherein:
the at least one image includes a first image and a second image acquired subsequent to the first image;
the comparison module is configured to determine a difference between the assigned radiodensity values of the one or more positions in the first image and the second image; and
the display module is configured to display in the graphical user interface at least one indicator superimposed on the one or more positions in the second image according to the difference in the assigned radiodensity values.

### Claim 7 (depends on 6)

The system as recited in claim 6, wherein:
the display module is configured to filter from the visual gradient any of the assigned radiodensity values below at least one predetermined threshold.

### Claim 8 (depends on 1)

The system as recited in claim 1, wherein the plurality of density members are distributed in an array along the main body.

### Claim 9 (depends on 8)

The system as recited in claim 8, wherein the density members include three or more density members, the respective predetermined radiodensity values being within a predetermined radiodensity range, and wherein the predetermined radiodensity range is greater than or equal to about 300.0 HU, and is less than or equal to about 1800.0 HU.

### Claim 10 (depends on 8)

The system as recited in claim 8, wherein:
the calibration object includes a pair of registration members established on opposed sides of the array of the density members; and
the planning environment includes a spatial module configured to determine the one or more respective positions along the density members in the at least one image in response to identifying respective positions of the pair of registration members in the at least one image.

### Claim 11

A method for calibrating images of anatomy comprising:
printing a calibration object, wherein the calibration object includes a plurality of density members having radiodensities corresponding to respective predetermined radiodensity values;
positioning the calibration object in a scan field of an imaging device;
capturing, by the imaging device, at least one image of a patient anatomy together with the calibration object in the scan field;
determining one or more image gradients, each of the one or more image gradients based on a comparison of a pixel value at a respective position in the at least one image and a pixel value at one or more respective positions along the density members in the at least one image;
comparing the respective one or more image gradients to each respective predetermined radiodensity value;
assigning a radiodensity value to one or more positions in the at least one image based upon the comparing; and
displaying in a graphical user interface at least one indicator relating to the assigned radiodensity values.

### Claim 12 (depends on 11)

The method as recited in claim 11, wherein the calibration object includes a pair of registration members established at predetermined positions relative to the radiodensity members, and further comprising:
determining the one or more respective positions along the density members in the at least one image in response to identifying respective positions of the pair of registration members in the at least one image.

### Claim 13 (depends on 11)

The method as recited in claim 11, further comprising:
displaying in a graphical user interface the at least one image and the at least one indicator;
wherein the at least one indicator is a visual gradient superimposed on the one or more positions along the patient anatomy according to the assigned radiodensity values, and the visual gradient is defined by the predetermined radiodensity values associated with the density members.

### Claim 14 (depends on 13)

The method as recited in claim 13, further comprising:
positioning a selected implant along the patient anatomy based on the visual gradient.

### Claim 15 (depends on 11)

The method as recited in claim 11, wherein the imaging device is configured to capture the at least one image according to a plurality of scan parameters, the plurality of scan parameters including an exposure time parameter, a voltage parameter and an amperage parameter, and further comprising:
setting, prior to the capturing step, at least one of the scan parameters in response to a previous iteration of the determining step.

### Claim 16 (depends on 15)

The method as recited in claim 15, further comprising:
generating a histogram graph comprising a frequency of the assigned radiodensity values;
comparing a profile of the histogram graph to a predetermined profile; and
wherein the setting step occurs in response to the comparing the profile.

### Claim 17 (depends on 11)

The method as recited in claim 11, wherein the patient anatomy includes a cortical wall surrounding a cancellous region of a bone associated with a joint.