IP Library Granted Patent US 11,707,327
Granted Patent B2
US 11,707,327 · App. 17/529,993 · Granted Jul 25, 2023

Systems and methods for modeling spines and treating spines based on spine models

Inventors: John Schmidt (Bluemont, VA); Margaret Redford (Isle of Palms, SC); Jennifer McCool (Boyce, VA); Anthony Young (Annandale, VA); Noah Q. Johnson (Leesburg, VA); Kylie Pleakis (Bradford, PA)
Assignee: K2M, Inc.
A61B34/10G06T7/0012G06T19/20A61B2034/105G06T2207/10116G06T2207/30012G06T2210/41G06T2219/2016
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Quick Facts
Patent No.
US 11,707,327
App. No.
17/529,993
Granted
Jul 25, 2023
Kind
B2
Abstract

Disclosed are systems and methods for rapid generation of simulations of a patient's spinal morphology that enable pre-operative viewing of a patient's condition and to assist surgeons in determining the best corrective procedure and with any of the selection, augmentation or manufacture of spinal devices based on the patient specific simulated condition. The simulation is generated by morphing a generic spine model with a three-dimensional curve representation of the patient's particular spinal morphology derived from existing images of the patient's condition.

Claims (42)

1. A method, comprising:

obtaining a first X-ray image of at least a portion of a spine of a target patient in a first plane;

obtaining a second X-ray image of the at least a portion of the spine of the target patient in a second plane;

drawing a line through vertebral bodies of the at least a portion of the spine of the target patient in the first X-ray image and in the second X-ray image;

constructing a three-dimensional model associated with the target patient based on the lines drawn on the first and second X-ray images;

acquiring medical data associated with a reference patient different from the target patient;

predicting, based on the three-dimensional model associated with the target patient in view of the medical data associated with the reference patient, postoperative changes to movement of the spine of the target patient over time; and

determining parameters of a spinal device based on the predicted postoperative changes to movement of the spine of the target patient.

2. The method of claim 1 , wherein the parameters of the spinal device are determined based on predicted postoperative changes which include: a first predicted postoperative change to movement of the spine of the target patient at a first time, and one or more additional predicted postoperative changes at times subsequent to the first time.

3. The method of claim 1 , wherein the spinal device is a screw, a rod, a cervical plate, a spine implant, an interbody device, or an artificial disc.

4. The method of claim 1 , wherein the first plane is a coronal plane and the second plane is a sagittal plane.

5. The method of claim 1 , further comprising obtaining a third X-ray image of the at least a portion of the spine of the target patient in an axial plane.

6. The method of claim 5 , wherein constructing the three-dimensional model associated with the target patient includes constructing the three-dimensional model associated with the target patient based on the lines drawn on the first, second, and third X-ray images.

7. The method of claim 1 , wherein the method further comprises:

identifying a line on the first X-ray image; and

identifying a line on the second X-ray image.

8. The method of claim 7 , wherein the line on the first X-ray image and the line on the second X-ray image are colored lines and identifying the colored lines includes quantifying the color of the colored lines and identifying differences in characteristics of the colored lines;

wherein the color of the colored lines includes at least one of red, green, or blue; and

wherein the characteristics include at least one of intensity, hue, saturation, contrast, or brightness.

9. The method of claim 1 , further comprising calibrating the first X-ray image and the second X-ray image.

10. The method of claim 1 , further comprising:

obtaining coronal Y-Z coordinates or pixels of a central vertebral line with vertebral bodies and discs identified; and

obtaining sagittal X-Z coordinates or pixels.

11. The method of claim 1 , further comprising compensating for differences in magnification between the first X-ray image and the second X-ray image.

12. The method of claim 11 , further comprising scaling the first and second X-ray images.

13. The method of claim 1 , further comprising combining the first X-ray image and the second X-ray image to construct the three-dimensional model associated with the target patient.

14. The method of claim 1 , further comprising evaluating spines of a plurality of different reference patients for similarities to the spine of the target patient.

15. The method of claim 1 , further comprising comparing medical data of the target patient with medical data of a plurality of different reference patients.

16. The method of claim 1 , wherein acquiring the medical data associated with the reference patient different from the target patient includes obtaining a plurality of different four-dimensional models of spines.

17. The method of claim 16 , further comprising:

generating a respective score for each of the plurality of different four-dimensional models of spines based on a comparison to the three-dimensional model associated with the target patient; and

comparing the respective scores against a predetermined score to predict movement of the spine of the target patient.

18. The method of claim 17 , further comprising generating a consolidated four-dimensional model from the plurality of different four-dimensional models of spines with respective scores greater than the predetermined score to predict movement of the spine of the target patient.

19. The method of claim 1 , wherein acquiring the medical data associated with the reference patient different from the target patient includes obtaining at least one four-dimensional model for a similar spine of the reference patient.

20. The method of claim 19 , further comprising:

analyzing the three-dimensional model associated with the target patient based on the at least one four-dimensional model for the similar spine of the reference patient to predict movement of the spine of the target patient; and

determining the parameters of the spinal device based on the predicted movement of the spine of the target patient.

21. The method of claim 20 , wherein the similar spine of the reference patient is an abnormal spine; and

wherein the spine of the target patient is a one-level degenerative disc case and the similar spine of the reference patient is a two-level degenerative disc case.

22. The method of claim 1 , wherein the medical data associated with the reference patient includes at least one of diagnosis information, operative information, follow-up information, quality of life score, cardia information, diabetes information, radiographic information, or intra-operative information.

23. The method of claim 22 , wherein the quality of life score is selected from the group consisting of Visual Analog Scale (VAS), Oswestry Disability Index (ODI), Neck Disability Index, Rowland-Morris, Short Form Health Survey-12, Short Form Health Survey-36, Scoliosis Research Society-36 (SRS36), and Scoliosis Research Society-22 (SRS-22).

24. The method of claim 1 , further comprising generating instructions to construct the spinal device with a three-dimensional printer based on the parameters of the spinal device.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 12, 2025
From: K2M, INC.
To: STRYKER CORPORATION
Reel/Frame 071271/0170 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 13, 2022
From: SCHMIDT, JOHN A.; REDFORD, MARGARET; MCCOOL, JENNIFER; YOUNG, ANTHONY; JOHNSON, NOAH; PLEAKIS, KYLIE
To: K2M, INC.
Reel/Frame 058648/0733 →
Continuity (5)
Continuation 16630752
Continuation 15648086 · Jul 12, 2017
Provisional Application 62666305 · May 3, 2018
Provisional Application 62565586 · Sep 29, 2017
Related Publication 20220151699A1 · May 19, 2022
Cited By (1)
US 12,412,666