Granted Patent B2

US 10,318,655 · App. 14/914,474 · Granted Jun 11, 2019

Inventors: Thomas Mosnier (Anthon, FR); David Ryan (Collonges Au Mont d'Or, FR); Vincent Fiere (Lyons, FR)

Assignee: Medicrea International

G06F17/50A61B17/7011A61B34/10A61B2017/568A61B2034/105A61B2034/108

Abstract

Claims (79)

1. A method for producing a curvature of a rod of vertebral osteosynthesis material designed to support a vertebral column of a patient, the method comprising:

taking a sagittal preoperative x-ray of a vertebral column of a patient to be treated;

identifying on the sagittal preoperative x-ray:

one or more pelvic parameters;

a lumbar lordosis;

a position of an apical lumbar vertebra;

at least one of the following measurements:

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; and

a plurality of points defining a preoperative curvature of the vertebral column of the patient, wherein the plurality of points comprises one point per vertebral level;

deducing, among predetermined vertebral column morphotypes, a morphotype to which the vertebral column corresponds, deducing a desired postoperative apex point, and defining the vertebrae in which one or more anchor members for a vertebral rod to be anchored to the vertebrae will be implanted;

defining, from the one or more pelvic parameters, a reference centered at the plate of S1;

adjusting a position of one or more of the plurality of points and drawing a plurality of arcs through the one or more of the plurality of points, wherein at least one of the plurality of arcs is tangent to another one of the plurality of arcs, and wherein an arc extending from S1 is tangent to a straight line perpendicular to the plate of S1;

determining values of lengths of the plurality of arcs;

simulating a correction to be applied to a lumbar segment to be treated, wherein simulating the correction comprises:

drawing a straight line tangent to the desired postoperative apex point, moving the straight line to a vertical position such that an arc attached to the straight line is tangent to the desired postoperative apex point, the desired postoperative apex point being repositioned so as to become an apex point of the modeled vertebral column segment;

adjusting a first subset of the plurality of arcs situated below the apex point to make the first subset of the plurality of arcs co-radial to each other and adjusting a second subset of the plurality of arcs situated above the apex point to make the second subset of the plurality of arcs co-radial to each other, and obtain a first curvature above the apex point and a second curvature below the apex point;

defining the lumbar lordosis as being within ten degrees of a pelvic incidence, and defining one or more of:

an SVA distance smaller than 5 cm;

an SVA/SFD ratio between −1.9 and +0.1, wherein the SVA/SFD ratio is positive on a side of the vertical of the posterior upper point of the plate of S1 situated toward the femoral head, and wherein the SVA/SFD ratio is negative on a side of the vertical situated opposite the femoral head; or

a T1/SPI angle between −9° and 0°, wherein the T1/SPI angle is negative on a side of the vertical at the center of T1 located toward the femoral head;

defining a first concentric arc and a second concentric arc, wherein the first concentric arc is concentric to the first curvature above the apex point, and wherein the second concentric arc is concentric to the second curvature below the apex point, wherein the first concentric arc and the second concentric arc form a curved segment representing a desired curvature of the rod to be implanted in order to obtain the correction of the vertebral column to be treated; and

translating the curved segment away from a mean line of the vertebral column, over a mean of distances between a center of the vertebrae to each of the one or more anchor points of the anchor members for anchoring the rod to the vertebrae of the vertebral column to be treated, such that a position of the curved segment corresponds to a position the rod will assume once implanted;

defining a diameter of the rod to be implanted;

defining a two- or three-dimensional model of the rod, curved along the curved segment;

transmitting data relating to the desired curvature of the rod to a production unit; and

from a straight rod, physically producing the curvature of the rod by the production unit according to the model.

2. The method 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°.

3. The method of claim 1 , wherein defining the two- or three-dimensional modeling comprises establishing a drawing or plan of the rod to be produced.

4. The method of claim 1 , wherein the curvature of the rod is physically produced by cold bending.

5. The method of claim 1 , wherein data relating to the desired curvature of the rod is transmitted to a service provider that operates the production unit for physically producing the curvature of the rod.

6. The method of claim 1 , wherein the one or more pelvic parameters comprises one or more of a sacral slope, a pelvic version, or a pelvic incidence.

7. The method of claim 1 , wherein the apical lumbar vertebra is situated furthest forward on the sagittal preoperative x-ray.

8. The method of claim 1 , wherein the sagittal preoperative x-ray of the vertebral column extends from the cervical vertebrae to the femoral head.

9. The method of claim 1 , wherein the two- or three-dimensional model of the rod is defined using CAD software.

10. A system for producing a desired curvature of a rod of vertebral osteosynthesis material designed to support a vertebral column of a patient, the system comprising:

an interface configured to analyze a sagittal preoperative x-ray of a vertebral column of a patient to be treated, wherein the sagittal preoperative x-ray is analyzed by identifying on the sagittal preoperative x-ray:

one or more pelvic parameters;

a lumbar lordosis;

a position of an apical lumbar vertebra;

at least one of the following measurements:

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; and

a plurality of points defining a preoperative curvature of the vertebral column of the patient, wherein the plurality of points comprises one point per vertebral level;

the interface further configured to determine, among predetermined vertebral column morphotypes, a morphotype to which the vertebral column corresponds, determine a desired postoperative apex point, and defining the vertebrae in which one or more anchor members for a vertebral rod to be anchored to the vertebrae will be implanted;

the interface further configured to define, from the one or more pelvic parameters, a reference centered at the plate of S1;

the interface further configured to adjust a position of one or more of the plurality of points and draw a plurality of arcs through the one or more of the plurality of points, wherein at least one of the plurality of arcs is tangent to another one of the plurality of arcs, and wherein an arc extending from S1 is tangent to a straight line perpendicular to the plate of S1;

the interface further configured to determine values of lengths of the plurality of arcs;

the interface further configured to simulate a correction to be applied to a lumbar segment to be treated, wherein simulating the correction comprises:

drawing a straight line tangent to the desired postoperative apex point, moving the straight line to a vertical position such that an arc attached to the straight line is tangent to the desired postoperative apex point, the desired postoperative apex point being repositioned so as to become an apex point of the modeled vertebral column segment;

adjusting a first subset of the plurality of arcs situated below the apex point to make the first subset of the plurality of arcs co-radial to each other and adjusting a second subset of the plurality of arcs situated above the apex point to make the second subset of the plurality of arcs co-radial to each other, and obtain a first curvature above the apex point and second curvature below the apex point;

defining the lumbar lordosis as being within ten degrees of a pelvic incidence, and defining one or more of:

an SVA distance smaller than 5 cm;

an SVA/SFD ratio between −1.9 and +0.1, wherein the SVA/SFD ratio is positive on a side of the vertical of the posterior upper point of the plate of S1 situated toward the femoral head, and wherein the SVA/SFD ratio is negative on a side of the vertical situated opposite the femoral head; or

a T1/SPI angle between −9° and 0°, wherein the T1/SPI angle is negative on a side of the vertical at the center of T1 located toward the femoral head;

defining a first concentric arc and a second concentric arc, wherein the first concentric arc is concentric to the first curvature above the apex point, and wherein the second concentric arc is concentric to the second curvature below the apex point, wherein the first concentric arc and the second concentric arc form a curved segment representing a desired curvature of the rod to be implanted in order to obtain the correction of the vertebral column to be treated; and

translating the curved segment away from a mean line of the vertebral column, over a mean of distances between a center of the vertebrae to each of the one or more anchor points of the anchor members for anchoring the rod to the vertebrae of the vertebral column to be treated, such that a position of the curved segment corresponds to a position the rod will assume once implanted;

the interface further configured to define a diameter of the rod to be implanted;

the interface further configured to define a two- or three-dimensional model of the rod, curved along the curved segment;

the interface further configured to transmit data relating to the desired curvature of the rod to a production unit; and

the production unit configured to physically produce, from a straight rod, the curvature of the rod according to the model,

wherein the interface comprises a computer processor and an electronic storage medium.

11. The system of claim 10 , 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°.

12. The system of claim 10 , wherein the two- or three-dimensional modeling is defined by establishing a drawing or plan of the rod to be produced.

13. The system of claim 10 , wherein the curvature of the rod is physically produced by cold bending.

14. The system of claim 10 , wherein the one or more pelvic parameters comprises one or more of a sacral slope, a pelvic version, or a pelvic incidence.

15. The system of claim 10 , wherein the apical lumbar vertebra is situated furthest forward on the sagittal preoperative x-ray.

16. The system of claim 10 , wherein the sagittal preoperative x-ray of the vertebral column extends from the cervical vertebrae to the femoral head.

17. The system of claim 10 , wherein the two- or three-dimensional model of the rod is defined using CAD software.

Assignments (3)

Priority Claims (1)

Continuity (1)

Cited By (9)

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