Methods, systems, and devices for designing and manufacturing a spinal rod

Patent metadata

Field	Value
Publication number	US-10970426-B2
Application number	US-201916389348-A
Country	US
Kind code	B2
Filing date	Apr 19, 2019
Priority date	Sep 18, 2013
Publication date	Apr 6, 2021
Grant date	Apr 6, 2021

Abstract

In some embodiments, the systems, devices, and methods described herein are configured to produce a desired curvature of a customized spinal rod to support a vertebral column of a patient by analyzing a preoperative x-ray image of the vertebral column of the patient, determining a morphotype to which the vertebral column corresponds to, simulating a correction to be applied to the vertebral column, deducing a curved segment representing the desired curvature of the customized spinal rod based on the analyzed preoperative x-ray image of the vertebral column of the patient, and transmitting data related to the desired curvature of the customized spinal to a production system configured to physically produce the desired curvature of the customized spinal rod.

First claim

What is claimed is:

1. A system for producing a desired curvature of a customized spinal rod to support a vertebral column of a patient, the system comprising:
an interface configured to analyze a preoperative x-ray image of a vertebral column of a patient including cervical vertebrae and femoral head of the patient, wherein the preoperative x-ray image is analyzed by identifying on the preoperative x-ray image one or more of an apex point or one or more lordosis parameters, wherein the apex point comprises a forwardmost point of the vertebral column on the preoperative x-ray image, and wherein the one or more lordosis parameters comprises a difference between pelvic incidence and lumbar lordosis;
the interface further configured to determine, among one or more predetermined vertebral column morphotypes, a morphotype to which the vertebral column corresponds;
the interface further configured to perform a wire modeling of the vertebral column of the patient;
the interface further configured to simulate a correction to be applied to a lumbar segment to be treated, wherein simulating the correction comprises one or more of:
repositioning the apex point and obtaining a first curvature above the repositioned apex point and a second curvature below the repositioned apex point; or
redefining the lumbar lordosis;

the interface further configured to deduce a curved segment representing a desired curvature of the customized spinal rod based at least in part on one or more of the redefined lumbar lordosis or the first curvature above the repositioned apex point and the second curvature below the repositioned apex point; and
the interface further configured to transmit data relating to the desired curvature of the customized spinal rod to a production system configured to physically produce, from a spinal rod, the desired curvature of the customized spinal rod,
wherein the interface comprises a computer processor and an electronic storage medium.

2. The system of claim 1 , wherein the lumbar lordosis is redefined as being within ten degrees of a pelvic incidence.

3. The system of claim 1 , wherein the preoperative x-ray image is further analyzed by identifying on the preoperative x-ray image one or more pelvic parameters.

4. The system of claim 3 , wherein the one or more pelvic parameters comprises one or more of a sacral slope, pelvic version, or pelvic incidence.

5. The system of claim 1 , wherein the preoperative x-ray image comprises a sagittal x-ray image.

6. The system of claim 1 , wherein the preoperative x-ray image comprises an image of the vertebral column extending from the cervical vertebrae to the femoral head.

7. The system of claim 1 , wherein the wire modeling of the vertebral column of the patient comprises drawing a plurality of arcs through one or more of a plurality of points defining a preoperative curvature of the vertebral column of the patient.

8. The system of claim 1 , wherein the customized spinal rod comprises vertebral osteosynthesis material.

9. The system of claim 1 , wherein the preoperative x-ray image is further analyzed by identifying on the preoperative x-ray image one or more of:
a SVA distance from a vertical of a posterior upper point of a plate of a first vertebra of a sacrum (S1) to a vertical passing through a center of a seventh cervical vertebra;
a SFD distance from the vertical of the posterior upper point of the plate of S1 to a vertical passing through a center of a femoral head; or
a T1/SPI angle formed between a segment going from a center of a first dorsal vertebra (T1) to the center of the femoral head and a vertical line extending from the center of T1.

10. The system of claim 1 , wherein the predetermined vertebral column morphotypes comprise one or more of:
a type 1 morphotype, in which a forwardmost point of the vertebral column is situated at a median plane of L5, and an SS criterion corresponds to an angle smaller than 35°;
a type 2 morphotype, in which the forwardmost point of the vertebral column is situated at a base of L4, and the SS criterion corresponds to an angle smaller than 35°;
a type 3 morphotype, in which the forwardmost point of the vertebral column is situated at a median plane of L4, and the SS criterion corresponds to an angle between 35° and 45°; or
a type 4 morphotype, in which the forwardmost point of the vertebral column is situated at a base of L3, and the SS criterion corresponds to an angle larger than 45°.

11. The system of claim 1 , wherein the interface is further configured to generate a two-dimensional or three-dimensional model of the customized spinal rod.

12. The system of claim 1 , wherein the interface is further configured to generate a desired diameter of the customized spinal rod.

13. A method for producing a desired curvature of a customized spinal rod to support a vertebral column of a patient, the method comprising:
analyzing a preoperative x-ray image of a vertebral column of a patient including cervical vertebrae and femoral head of the patient by identifying on the preoperative x-ray image one or more of an apex point or one or more lordosis parameters, wherein the apex point comprises a forwardmost point of the vertebral column on the preoperative x-ray image, and wherein the one or more lordosis parameters comprises a difference between pelvic incidence and lumbar lordosis;
determining, among one or more predetermined vertebral column morphotypes, a morphotype to which the vertebral column corresponds;
performing a wire modeling of the vertebral column of the patient;
simulating a correction to be applied to a lumbar segment to be treated, wherein the simulating the correction comprises one or more of:
repositioning the apex point and obtaining a first curvature above the repositioned apex point and a second curvature below the repositioned apex point; or
redefining the lumbar lordosis;

deducing a curved segment representing a desired curvature of the customized spinal rod based at least in part on one or more of the redefined lumbar lordosis or the first curvature above the repositioned apex point and the second curvature below the repositioned apex point; and
transmitting data relating to the desired curvature of the customized spinal rod to a production system configured to physically produce, from a spinal rod, the desired curvature of the customized spinal rod.

14. The method of claim 13 , further comprising generating a desired diameter of the customized spinal rod.

15. The method of claim 13 , wherein the preoperative x-ray image comprises a sagittal x-ray image.

16. The method of claim 13 , wherein the predetermined vertebral column morphotypes comprise one or more of:
a type 1 morphotype, in which a forwardmost point of the vertebral column is situated at a median plane of L5, and an SS criterion corresponds to an angle smaller than 35°;
a type 2 morphotype, in which the forwardmost point of the vertebral column is situated at a base of L4, and the SS criterion corresponds to an angle smaller than 35°;
a type 3 morphotype, in which the forwardmost point of the vertebral column is situated at a median plane of L4, and the SS criterion corresponds to an angle between 35° and 45°; or
a type 4 morphotype, in which the forwardmost point of the vertebral column is situated at a base of L3, and the SS criterion corresponds to an angle larger than 45°.

17. The method of claim 13 , wherein the lumbar lordosis is redefined as being within ten degrees of a pelvic incidence.

18. The method of claim 13 , wherein analyzing the preoperative

Assignees

• Medicrea Int
• Medicrea Int Sa

Inventors

• Mosnier Thomas
• Ryan David
• Fiere Vincent

Classifications

• G06F30/10

  Geometric CAD · CPC title

• G06F30/00 Primary

  Computer-aided design [CAD] · CPC title

• A61B17/7001 Primary

  Screws or hooks combined with longitudinal elements which do not contact vertebrae (A61B17/7058 takes precedence) · CPC title

• A61B17/7011 Primary

  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) · CPC title

• A61B2017/568

  produced with shape and dimensions specific for an individual patient · CPC title