# US 10,864,023 B2 · Surgical implant preparation system and method

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- Number: US 10,864,023 B2
- Document ID: US10864023B2
- Status: Granted
- Kind: B2
- Application number: 16/140,491
- Filed: 2018-09-24
- Published: 2019-11-07
- Granted: 2020-12-15
- Earliest claimed: 2018-05-07
- Assignees: Clariance
- Applicants: Clariance SAS
- Inventors: Shane S. Pak; Karlton E. Spindle
- Web page: https://patentgrep.com/patent/US10864023B2

## CPC

- A61B 17/7074: {Tools specially adapted for spinal fixation operations other than for bone removal or filler handling (A61B17/7062, A61B17/808, A61B17/8858 take precedence; for spinal image producing devices A61B90/36, A61B34/20; markers A61B90/39)}
- G16H 30/40: for processing medical images, e.g. editing
- A61B 17/7002: {Longitudinal elements, e.g. rods}
- A61B 17/7031: {made wholly or partly of flexible material}
- A61B 17/7032: {Screws or hooks with U-shaped head or back through which longitudinal rods pass}
- A61B 17/8863: {Apparatus for shaping or cutting osteosynthesis equipment by medical personnel}
- A61B 34/10: Computer-aided planning, simulation or modelling of surgical operations
- G06F 30/20: Design optimisation, verification or simulation (optimisation, verification or simulation of circuit designs G06F30/30)
- G16H 20/40: relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
- G16H 50/50: for simulation or modelling of medical disorders
- A61B 2017/00057: {Light}
- A61B 2034/104: {Modelling the effect of the tool, e.g. the effect of an implanted prosthesis or for predicting the effect of ablation or burring}
- A61B 2034/108: {Computer aided selection or customisation of medical implants or cutting guides}
- 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
- G06F: ELECTRIC DIGITAL DATA PROCESSING (computer systems based on specific computational models G06N)

## Abstract

A system to precisely contour a surgical implant based on intraoperative information is disclosed.

## Claims

### Claim 1

A system for intraoperatively contouring a spinal rod for placement onto the spine of a patient, comprising:
a first contoured surrogate spinal rod,
a second contoured surrogate spinal rod,
a scanning assembly configured to scan the first contoured surrogate spinal rod and to output a first model based on the scan, and to scan the second contoured surrogate spinal rod and to output a second model based on the scan;
a controller configured to receive the first model and to perform at least one analysis on the first model; and
a contouring assembly configured to receive the first model from the controller and to contour the spinal rod based on the first model,
wherein the contour of the first and the second contoured surrogate spinal rod is based at least in part on the intraoperative position of one or more pedicle screws implanted into the patient's spine,
wherein the controller creates the second model based at least in part on the first model, the intraoperative position of the one or more pedicle screws and the position of the patient's spine; and
wherein the controller is configured to compare the first and second model to determine whether they deviate from each other by more than a predetermined threshold.

### Claim 2 (depends on 1)

The system of claim 1 wherein the controller is configured to provide feedback relating to the results of the at least one analysis.

### Claim 3 (depends on 1)

The system of claim 1 wherein the at least one analysis is based at least in part on the intraoperative position of the one or more pedicle screws and the position of the patient's spine.

### Claim 4 (depends on 3)

The system of claim 3 wherein the at least one analysis is chosen from the group consisting of: load bearing analysis, stress analysis and failure analysis.

### Claim 5 (depends on 1)

The system of claim 1 wherein the controller performs at least one analysis on the second model.

### Claim 6 (depends on 5)

The system of claim 5 wherein the at least one analysis is chosen from the group consisting of: load bearing analysis, stress analysis and failure analysis.

### Claim 7 (depends on 5)

The system of claim 5 wherein the results of the at least one analysis are compared with the pull-out strength of the one or more pedicle screws.

### Claim 8 (depends on 5)

The system of claim 5 wherein the controller is configured to provide feedback relating to the results of the at least one analysis.

### Claim 9 (depends on 7)

The system of claim 7 wherein the controller is configured to provide feedback relating to the comparison.

### Claim 10 (depends on 1)

The system of claim 1 wherein the scanning assembly is a three dimensional scanner.

### Claim 11 (depends on 1)

The system of claim 1 wherein the contouring assembly is a rod bending machine.

### Claim 12 (depends on 1)

The system of claim 1 wherein the first model is a three dimensional model of the contoured surrogate spinal rod.

### Claim 13

A method for intraoperatively contouring a spinal rod using a system comprising:
a first and second contoured surrogate spinal rod;
a scanning assembly;
a controller; and
a contouring assembly;
the method comprising:
(A) using the scanning assembly, scanning the first contoured surrogate spinal rod to create a first model;
(B) using the controller, performing at least one analysis on the first model created in (A);
(B)(1) using the controller, creating a second model from the second contoured surrogate spinal rod and also based at least in part on the first model, the intraoperative position of one or more pedicle screws implanted into the patient's spine, and the position of the patient's spine;
(B) (3) comparing the first and second model to confirm that they do not deviate from each other by more than a predetermined threshold;
(C) using the controller, providing feedback relating to the results of the at least one analysis performed in (B);
(D) providing the first model to the contouring assembly; and
(E) using the contouring assembly, contouring the spinal rod based on the model created in (A).

### Claim 14 (depends on 13)

The method of claim 13 wherein the at least one analysis in (B) is chosen from the group consisting of: load bearing analysis, stress analysis and failure analysis.

### Claim 15

A method for intraoperatively contouring a spinal rod using a system comprising:
a first and second contoured surrogate spinal rod;
a scanning assembly;
a controller; and
a contouring assembly;
the method comprising:
(A) using the scanning assembly, scanning the first contoured surrogate spinal rod to create a first model, and scanning the second contoured surrogate spinal rod to create a second model;
(B) using the controller, performing at least one analysis on the first model created in (A);
(B)(2) using the controller, performing at least one analysis on the second model;
(B) (3) using the controller, comparing the first and second model to confirm that they do not deviate from each other by more than a predetermined threshold;
(C) using the controller, providing feedback relating to the results of the at least one analysis performed in (B);
(D) providing the first model to the contouring assembly; and
(E) using the contouring assembly, contouring the spinal rod based on the first model created in (A).

### Claim 16 (depends on 15)

The method of claim 15 wherein the at least one analysis in (B)(2) is chosen from the group consisting of: load bearing analysis, stress analysis and failure analysis.
