IP Library Granted Patent US 11,950,852
Granted Patent B2
US 11,950,852 · App. 17/036,506 · Granted Apr 9, 2024

Systems and methods for determining intraoperative spinal orientation

Inventors: Michael K. K. Leung (Markham, CA); Adrian Mariampillai (Toronto, CA); Beau Anthony Standish (Toronto, CA); Peter Siegler (Toronto, CA); Victor X. D. Yang (North York, CA)
Assignee: 7D SURGICAL ULC
A61B34/20A61B17/70A61B17/7074A61B2034/105A61B2034/107A61B2034/2065A61B2034/2074
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Quick Facts
Patent No.
US 11,950,852
App. No.
17/036,506
Granted
Apr 9, 2024
Kind
B2
Abstract

Systems and methods are disclosed whereby a surface detection system is employed to obtain intraoperative surface data characterizing an exposed surface of the spine. In some embodiments, this intraoperative surface data is registered to segmented surface data obtained from volumetric data of the spine in order to assess the intraoperative orientation of the spine and provide feedback associated with the intraoperative orientation of the spine. The feedback may characterize the intraoperative spinal orientation as a change relative to the preoperative orientation.

Claims (66)

1. A method of determining an intraoperative orientation of a spine, the method comprising:

processing volumetric image data pertaining to a spine to generate multi-level surface data characterizing a bone surface of the spine;

processing the multi-level surface data to generate segmented surface data on a per-level basis for each level of a plurality of spinal levels;

for each spinal level of the plurality of spinal levels, performing a surface-to-surface registration between the segmented surface data associated with said each spinal level and intraoperative surface data characterizing surface regions associated with each spinal level of the plurality of spinal levels, thereby obtaining a registration transform associated with said each spinal level; and

employing the registration transforms associated with the plurality of spinal levels to generate and display one or more parameters numerically quantifying a relative intraoperative orientation and/or relative intraoperative position of at least one of the spinal levels.

2. The method according to claim 1 wherein the one or more parameters comprise a relative angle characterizing the intraoperative orientation of a spinal level.

3. The method according to claim 1 wherein one or more of the parameters enable a determination of an intraoperative angle between a pair of spinal levels.

4. The method according to claim 3 wherein the pair of spinal levels determined according to input received from a graphical user interface.

5. The method according to claim 3 wherein the pair of spinal levels are adjacent spinal levels.

6. The method according to claim 1 wherein the one or more parameters comprise an intraoperative angle between a pair of spinal levels.

7. The method according to claim 1 wherein one or more of the parameters enable a determination of an intraoperative angle between a pair of spinal levels relative to one of a coronal, sagittal and axial plane.

8. The method according to claim 1 wherein the one or more parameters comprise a distance characterizing the relative intraoperative position of a spinal level.

9. The method according to claim 1 wherein the one or more parameters comprise an intraoperative spatial separation between a pair of spinal levels.

10. The method according to claim 1 wherein one or more of the parameters are selected from the group consisting of sacral slope, pelvic incidence, pelvic tilt, sagittal vertical axis and coronal shift.

11. The method according to claim 1 wherein the one or more parameters include angles characterizing changes in intraoperative orientations of the spinal levels relative to the orientations of the spinal levels associated with the volumetric image data.

12. The method according to claim 1 wherein the one or more parameters include distances characterizing changes in intraoperative positions of the spinal levels relative to positions of the spinal levels associated with the volumetric image data.

13. The method according to claim 1 wherein an initial registration is obtained prior to performing the surface-to-surface registration, the initial registration employing volumetric fiducial points associated with said each spinal level and corresponding intraoperative fiducial points associated with said each spinal level.

14. The method according to claim 1 further comprising generating a visualization of intraoperative positions and orientations of the spinal levels.

15. The method according to claim 14 wherein the visualization associates, with each spinal level of the plurality of spinal levels, a location of the level and a vector indicative of an orientation of the level, wherein the location and the vector are determined based on the registration transforms.

16. The method according to claim 14 wherein the visualization comprises a three-dimensional image of the spine generated based on the registration transforms.

17. The method according to claim 14 wherein the visualization shows changes in intraoperative orientations and positions of the spinal levels relative to the orientations and positions of the spinal levels associated with the volumetric image data.

18. The method according to claim 1 further comprising:

employing a tracking system to track the position and/or orientation of a fiducial marker intraoperatively attached to the spine while obtaining the input identifying intraoperative fiducial points associated with each spinal level to compensate for the motion of the spine.

19. The method according to claim 1 wherein the segmented surface data is obtained by:

(i) obtaining input identifying at least three volumetric fiducial points at a pre-selected spinal level within a volumetric frame of reference associated with the volumetric image data;

(ii) employing at least one of the volumetric fiducial points associated with the pre-selected spinal level to perform segmentation on the multi-level surface data, thereby obtaining segmented surface data associated with the pre-selected spinal level;

(iii) employing the pre-selected spinal level as an initial spinal level when performing steps (iv) to (vi) for a first time;

(iv) determining an adjacent volumetric region, within the volumetric frame of reference, that is associated with an adjacent spinal level that is adjacent to the initial spinal level;

(v) performing segmentation on the multi-level surface data within the adjacent volumetric region, thereby obtaining adjacent segmented surface data associated with the adjacent spinal level;

(vi) registering the segmented surface data associated with the initial spinal level to the adjacent segmented surface data, thereby obtaining an inter-level transform between the initial spinal level and the adjacent spinal level;

(vii) repeating steps (iv) to (vi) one or more times, each time using the previous adjacent level as the initial level, to generate segmented surface data and the inter-level transforms associated with additional spinal levels of the plurality of spinal levels on a first side of said pre-selected spinal level, such that each inter-level transform is between adjacent spinal levels;

(viii) repeating steps (iii) to (vii) if additional spinal levels of said plurality of spinal levels reside on the other side of said pre-selected spinal level; and

(ix) employing the inter-level transforms and the volumetric fiducial points associated with the pre-selected spinal level to obtain volumetric fiducial points associated with the other spinal levels of the plurality of spinal levels.

20. The method according to claim 19 wherein employing the inter-level transforms and the volumetric fiducial points associated with the pre-selected spinal level to obtain volumetric fiducial points associated with the other spinal levels of the plurality of spinal levels comprises:

(x) applying the inter-level transform between the pre-selected spinal level and an adjacent spinal level to the volumetric fiducial points associated with the pre-selected spinal level, thereby obtaining estimated volumetric fiducial locations associated with the adjacent spinal level;

(xi) employing the estimated volumetric fiducial locations to determine volumetric fiducial points residing within the segmented surface defined by the segmented surface data corresponding to the adjacent spinal level; and

(xii) repeating steps (x) and (xi) to determine the volumetric fiducial points associated with the additional spinal levels of the plurality of spinal levels.

21. The method according to claim 20 wherein intraoperative fiducial points are generated by:

obtaining input identifying at least three intraoperative fiducial points at a selected spinal level within an intraoperative frame of reference, wherein the selected spinal level in the intraoperative frame of reference is expected to correspond to the pre-selected spinal level in the volumetric frame of reference, and wherein the intraoperative fiducial points at the pre-selected spinal level correspond to the volumetric fiducial points at the pre-selected spinal level; and

employing the inter-level transforms and the intraoperative fiducial points associated with the selected spinal level to obtain intraoperative fiducial points associated with the other spinal levels of the plurality of spinal levels.

22. The method according to claim 21 wherein employing the inter-level transforms to obtain intraoperative fiducial points associated with the other spinal levels of the plurality of spinal levels comprises:

(x) employing the registration transform between the pre-selected spinal level and the selected spinal level to transform the intraoperative fiducial points associated with the selected spinal level into the volumetric frame of reference, thereby obtaining transformed intraoperative fiducial points;

(xi) applying the inter-level transform between the pre-selected spinal level and the adjacent spinal level to the transformed intraoperative fiducial points, thereby obtaining estimated adjacent fiducial locations associated with the adjacent spinal level;

(xi) employing the estimated adjacent fiducial locations to determine transformed adjacent fiducial points residing within the segmented surface data associated with the adjacent spinal level;

(xii) employing the registration transform associated with the adjacent spinal level to transform the transformed adjacent fiducial points into the intraoperative frame of reference, thereby obtaining intraoperative fiducial points associated with the adjacent spinal level; and

(xiii) repeating steps (x) and (xii) to determine the intraoperative fiducial points associated with the additional spinal levels of the plurality of spinal levels.

23. The method according to claim 1 wherein the surface detection subsystem is a structured light subsystem.

24. A system for determining an intraoperative orientation of a spine, the system comprising:

a surface detection subsystem; and

computer hardware operatively coupled to said surface detection subsystem, wherein said computer hardware comprises memory coupled with one or more processors to store instructions, which when executed by the one or more processors, causes the one or more processors to perform operations comprising:

processing volumetric image data pertaining to a spine to generate multi-level surface data characterizing a bone surface of the spine;

processing the multi-level surface data to generate segmented surface data on a per-level basis for each level of a plurality of spinal levels;

controlling said surface detection subsystem to intraoperatively detect intraoperative surface data characterizing surface regions associated with each spinal level of the plurality of spinal levels;

for each spinal level of the plurality of spinal levels, performing a surface-to-surface registration between the segmented surface data associated with said each spinal level and the intraoperative surface data, thereby obtaining a registration transform associated with said each spinal level; and

employing the registration transforms associated with the plurality of spinal levels to generate and display one or more parameters numerically quantifying a relative intraoperative orientation and/or relative intraoperative position of at least one of the spinal levels.

25. The system according to claim 24 wherein said computer hardware is configured such that the one or more of the parameters comprise a relative angle characterizing the intraoperative orientation of a spinal level.

26. The system according to claim 24 wherein said computer hardware is configured such that one or more of the parameters enable a determination of an intraoperative angle between a pair of spinal levels.

27. The system according to claim 26 wherein said computer hardware is configured such that the pair of spinal levels determined according to input received from a graphical user interface.

28. The system according to claim 26 wherein said computer hardware is configured such that the pair of spinal levels are adjacent spinal levels.

29. The system according to claim 24 wherein said computer hardware is configured such that one or more of the parameters comprise an intraoperative angle between a pair of spinal levels.

30. The system according to claim 24 wherein said computer hardware is configured such that one or more of the parameters enable a determination of an intraoperative angle between a pair of spinal levels relative to one of the coronal, sagittal and axial planes.

31. The system according to claim 24 wherein said computer hardware is configured such that the one or more parameters comprise a distance characterizing a relative intraoperative position of a spinal level.

32. The system according to claim 24 wherein said computer hardware is configured such that the one or more parameters comprise an intraoperative spatial separation between a pair of spinal levels.

33. The system according to claim 24 wherein said computer hardware is configured such that one or more of the parameters are selected from the group consisting of sacral slope, pelvic incidence, pelvic tilt, sagittal vertical axis and coronal shift.

34. The system according to claim 24 wherein said computer hardware is configured such that the one or more parameters include angles characterizing changes in intraoperative orientations of the spinal levels relative to the orientations of the spinal levels associated with the volumetric image data.

35. The system according to claim 24 wherein said computer hardware is configured such that the one or more parameters include distances characterizing changes in intraoperative positions of the spinal levels relative to positions of the spinal levels associated with the volumetric image data.

Assignments (6)
SECURITY INTEREST Recorded Jul 8, 2026
From: 7D SURGICAL ULC
To: OXFORD FINANCE LLC, AS AGENT
Reel/Frame 075210/0179 →
RELEASE OF SECURITY INTEREST Recorded Jan 9, 2023
From: WELLS FARGO BANK, NATIONAL ASSOCIATION
To: SEASPINE HOLDINGS CORPORATION; SEASPINE ORTHOPEDICS CORPORATION; SEASPINE, INC.; ISOTIS, INC.; SEASPINE SALES LLC; ISOTIS ORTHOBIOLOGICS, INC.; THEKEN SPINE, LLC; SEASPINE ORTHOPEDICS INTERMEDIATECO, INC.; 7D SURGICAL USA INC.
Reel/Frame 062336/0593 →
SECOND AMENDMENT TO PATENT SECURITY AGREEMENT Recorded Jul 18, 2022
From: SEASPINE HOLDINGS CORPORATION; SEASPINE ORTHOPEDICS CORPORATION; SEASPINE, INC.; ISOTIS, INC.; SEASPINE SALES LLC; ISOTIS ORTHOBIOLOGICS, INC.; THEKEN SPINE, LLC; SEASPINE ORTHOPEDICS INTERMEDIATECO, INC.; 7D SURGICAL USA INC.
To: WELLS FARGO BANK, NATIONAL ASSOCIATION, AS AGENT
Reel/Frame 060715/0395 →
CHANGE OF NAME Recorded Jul 21, 2021
From: PROJECT MAPLE LEAF ACQUISITION ULC
To: 7D SURGICAL ULC
Reel/Frame 056933/0176 →
CERTIFICATE OF AMALGAMATION Recorded Jul 21, 2021
From: 7D SURGICAL INC.
To: PROJECT MAPLE LEAF ACQUISITION ULC
Reel/Frame 056933/0416 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 29, 2020
From: LEUNG, MICHAEL K.K.; MARIAMPILLAI, ADRIAN; STANDISH, BEAU ANTHONY; SIEGLER, PETER; YANG, VICTOR X.D.
To: 7D SURGICAL INC.
Reel/Frame 053918/0390 →