# US 10,441,363 B1 · Methods, systems, and devices for designing and manufacturing a spinal rod

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- Number: US 10,441,363 B1
- Document ID: US10441363B1
- Status: Granted
- Kind: B1
- Application number: 16/414,086
- Filed: 2019-05-16
- Published: 2019-10-03
- Granted: 2019-10-15
- Earliest claimed: 2013-10-18
- Assignees: Medicrea International
- Applicants: Medicrea International
- Inventors: Thomas Mosnier; David Ryan
- Web page: https://patentgrep.com/patent/US10441363B1

## CPC

- A61B 34/10: Computer-aided planning, simulation or modelling of surgical operations
- A61B 17/7011: {Longitudinal element being non-straight, e.g. curved, angled or branched (adjustable length longitudinal elements A61B17/7014; A61B17/7019 takes precedence, e.g. coil springs)}
- A61B 17/8863: {Apparatus for shaping or cutting osteosynthesis equipment by medical personnel}
- G06T 7/0012: {Biomedical image inspection}
- G06T 7/337: {involving reference images or patches}
- A61B 2017/00526: {Methods of manufacturing}
- A61B 2017/568: {produced with shape and dimensions specific for an individual patient}
- A61B 2034/108: {Computer aided selection or customisation of medical implants or cutting guides}
- G06T 2207/10116: X-ray image
- G06T 2207/30012: Spine; Backbone
- G06T 2207/30052: Implant; Prosthesis
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- G06T: IMAGE DATA PROCESSING OR GENERATION, IN GENERAL

## Abstract

According to the invention, the process includes the steps of: a) taking a sagittal preoperative x-ray of the vertebral column of the patient to be treated, extending from the cervical vertebrae to the femoral heads; b) on that x-ray, identifying points on S1, S2, T12 et C7; c) depicting, on the said x-ray, curved segments beginning at the center of the plate of S1 et going to the center of the plate of C7; e) identifying, on that x-ray, the correction(s) to be made to the vertebral column, including the identification of posterior osteotomies to make; f) pivoting portions of said x-ray relative to other portions of that x-ray, according to osteotomies to be made; g) performing, on said x-ray, a displacement of the sagittal curvature segment extending over the vertebral segment to be corrected; h) from a straight vertebral rod (TV), producing the curvature of that rod according to the shape of said sagittal curvature segment in said displacement position.

## Claims

### Claim 1

A system for patient-specific spinal rod specification generation for producing a patient-specific implantable spinal rod for correcting a curvature of a vertebral column of a patient, the system comprising:
an electronic interface configured for accessing one or more preoperative images of the vertebral column of the patient, wherein the one or more preoperative images show a correction to be made to the vertebral column of the patient;
the electronic interface configured for calculating curvatures of a first curved segment and a second curved segment of the vertebral column represented in the one or more preoperative images, wherein the first curved segment of the vertebral column comprises a portion of the vertebral column below a reference point and the second curved segment of the vertebral column comprises a portion of the vertebral column above the reference point, wherein the second curved segment comprises a different curvature than the first curved segment;
the electronic interface configured for generating a patient-specific spinal rod specification based at least in part on the calculated curvatures of the first and second curved segments of the vertebral column, the generated patient-specific spinal rod specification configured for use by a manufacturing apparatus to manufacture the patient-specific implantable spinal rod; and
the electronic interface configured for electronically transferring the generated patient-specific spinal rod specification to a manufacturing system for producing the patient-specific implantable spinal rod comprising the calculated curvatures.

### Claim 2 (depends on 1)

The system of claim 1, wherein the first curved segment of the vertebral column comprises sacral vertebrae of the vertebral column.

### Claim 3 (depends on 1)

The system of claim 1, wherein the first curved segment of the vertebral column comprises one or more vertebrae between L1 to L5.

### Claim 4 (depends on 1)

The system of claim 1, wherein the first curved segment of the vertebral column comprises one or more vertebrae between a first vertebra of a sacrum and a lower plate of a reference dorsal vertebra.

### Claim 5 (depends on 4)

The system of claim 4, wherein the first curved segment of the vertebral column is tangent to a straight line from a center of a second vertebra of the sacrum to a center of the first vertebrae of the sacrum.

### Claim 6 (depends on 1)

The system of claim 1, wherein the second curved segment of the vertebral column comprises cervical vertebrae of the vertebral column.

### Claim 7 (depends on 1)

The system of claim 1, wherein the second curved segment of the vertebral column comprises one or more vertebrae between C6 to T11.

### Claim 8 (depends on 1)

The system of claim 1, wherein the one or more preoperative images of the vertebral column of the patient comprises one or more sagittal x-ray images.

### Claim 9 (depends on 1)

The system of claim 1, wherein the one or more preoperative images of the vertebral column of the patient comprises one or more sagittal x-ray images and one or more frontal x-ray images.

### Claim 10 (depends on 1)

The system of claim 1, further comprising the electronic interface configured for identifying one or more posterior osteotomies to be performed on the vertebral column of the patient.

### Claim 11 (depends on 1)

The system of claim 1, wherein the system comprises a computer processor and an electronic storage medium.

### Claim 12

A system for patient-specific spinal rod specification generation for producing a patient-specific implantable spinal rod for correcting a curvature of a vertebral column of a patient, the system comprising:
an interface configured for accessing one or more preoperative images of the vertebral column of the patient, wherein the one or more preoperative images show a correction to be made to the vertebral column of the patient;
the interface configured for calculating curvatures of a first curved segment and a second curved segment of the vertebral column represented in the one or more preoperative images, wherein the first curved segment of the vertebral column comprises a portion of the vertebral column below a reference point and the second curved segment of the vertebral column comprises a portion of the vertebral column above the reference point, wherein the second curved segment comprises a different curvature than the first curved segment;
the interface configured for generating a patient-specific spinal rod specification based at least in part on the calculated curvatures of the first and second curved segments of the vertebral column, the generated patient-specific spinal rod specification configured for use by an apparatus to produce the patient-specific implantable spinal rod; and
the interface configured for transferring the generated patient-specific spinal rod specification to cause the apparatus to produce a curvature of the patient-specific implantable spinal rod.

### Claim 13 (depends on 12)

The system of claim 12, wherein the system comprises a computer processor and an electronic storage medium.

### Claim 14 (depends on 12)

The system of claim 12, wherein the first curved segment of the vertebral column comprises sacral vertebrae of the vertebral column.

### Claim 15 (depends on 12)

The system of claim 12, wherein the first curved segment of the vertebral column comprises one or more vertebrae between L1 to L5.

### Claim 16 (depends on 13)

The system of claim 13, wherein the first curved segment of the vertebral column comprises one or more vertebrae between a first vertebra of a sacrum and a lower plate of a reference dorsal vertebra.

### Claim 17 (depends on 16)

The system of claim 16, wherein the first curved segment of the vertebral column is tangent to a straight line from a center of a second vertebra of the sacrum to a center of the first vertebrae of the sacrum.

### Claim 18 (depends on 12)

The system of claim 12, wherein the second curved segment of the vertebral column comprises cervical vertebrae of the vertebral column.

### Claim 19 (depends on 12)

The system of claim 12, wherein the second curved segment of the vertebral column comprises one or more vertebrae between C6 to T11.

### Claim 20 (depends on 12)

The system of claim 12, wherein the one or more preoperative images of the vertebral column of the patient comprises one or more sagittal x-ray images or frontal x-ray images.
