IP Library › Granted Patent US 12,274,510
Granted Patent B2
US 12,274,510 · App. 18/415,577 · Granted Apr 15, 2025

Patient-specific implant design and manufacturing system with a surgical implant positioning manager

Inventors: Niall Patrick Casey (Carlsbad, CA); Rodrigo Junqueira Nicolau (Cardiff, CA); Syed Shariq Hussain (Vista, CA); Jeffery Pennal (San Diego, CA); Matthew Chen (San Diego, CA)
Assignee: Carlsmed, Inc.
A61B34/10A61F2/4611G06T19/20G16H30/20G16H30/40A61B2034/102A61B2034/104A61B2034/105A61B2034/108A61B2034/252A61B2034/256A61B2090/364A61F2002/4633G06T2219/2004
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Quick Facts
Patent No.
US 12,274,510
App. No.
18/415,577
Filed
Jan 17, 2024
Granted
Apr 15, 2025
Kind
B2
Examiner
WU, SING-WAI
Art Unit
2611
USPC
703/11
Abstract

Systems and methods for designing and implementing patient-specific surgical procedures and/or medical devices are disclosed. In some embodiments, a method includes receiving intra-operative data during a surgical procedure to install a patient-specific implant in a patient. The system can compare the intra-operative data to a pre-operative plan to determine whether the implant is positioned and located according to the pre-operative plan.

Claims (99)

1. A method comprising:

(a) obtaining at least one image of an implant located in a patient, wherein the at least one image is a fluoroscopic image,

(b) identifying the implant in the at least one image;

(c) synchronizing a virtual anatomical model and the at least one image, wherein the synchronization includes performing an anatomical alignment between the virtual anatomical model and the fluoroscopic image, and

(d) comparing a position of the implant in the patient to a position of a virtual implant of the virtual anatomical model based on the synchronized virtual anatomical model and the at least one image; and

(e) repeating steps (a)-(d) to determine that the implant is positioned at an acceptable location in the patient based on the comparison, wherein the acceptable location is a maximum acceptable distance from a target location for the implant.

2. The method of claim 1 ,

wherein synchronizing the virtual anatomical model and the at least one image includes manipulating the virtual anatomical model and/or the at least one image according to a best fit routine, and

wherein steps (a)-(d) are repeated using images of the patient showing the implant at another location.

3. The method of claim 2 , wherein manipulating the virtual anatomical model and/or the at least one image includes at least one of zooming, stretching, or rotating the virtual anatomical model to align anatomical features in the virtual anatomical model with corresponding anatomical features in the at least one image.

4. The method of claim 2 , wherein manipulating the virtual anatomical model and/or the at least one image includes at least one of zooming, stretching, or rotating the at least one image to align the at least one intra-operative-image with the virtual anatomical model.

5. The method of claim 1 , further comprising determining the acceptable location in the patient using a machine learning engine, wherein the acceptable location is inputted by a user.

6. The method of claim 1 , further comprising sequentially receiving additional images of the patient to repeatedly perform steps (a)-(d) using a respective one of the additional images.

7. The method of claim 1 , further comprising:

retrieving a patient-specific surgical plan for the patient;

generating instructions for moving the implant toward a target location in the patient-specific surgical plan; and

causing the instructions to be intra-operatively outputted to assist with repositioning the implant.

8. A method comprising:

(a) obtaining at least one image of an implant located in a patient;

(b) identifying the implant in the at least one image;

(c) synchronizing a virtual anatomical model and the at least one image;

(d) comparing a position of the implant in the patient to a position of a virtual implant of the virtual anatomical model based on the synchronized virtual anatomical model and the at least one image; and

(e) repeating steps (a)-(d) to determine that the implant is positioned at an acceptable location in the patient based on the comparison;

wherein the method further comprises

obtaining type of implant information for the implant;

selecting an implant-type deviation analysis based on the type of implant information;

generating deviation annotation for positioning the implant that has been inserted into the patient based on the implant-type deviation analysis; and

displaying the deviation annotation via an electronic display.

9. The method of claim 8 , wherein the implant-type deviation analysis includes at least one of:

an interbody cage analysis for deviation annotation of vertebral endplate-based positioning for fusion,

an artificial disk analysis for deviation annotation of vertebral endplate-based positioning for joint articulation, or

a screw and rod fusion system analysis for vertebral body-based positioning for fusion.

10. A system comprising:

one or more processors; and

one or more memories storing instructions that, when executed by the one or more processors, cause the system to perform a process comprising:

a) obtaining at least one image of an implant located in a patient, wherein the at least one image is a fluoroscopic image,

(b) identifying the implant in the at least one image;

(c) synchronizing a virtual anatomical model and the at least one image, wherein the synchronization includes performing an anatomical alignment between the virtual anatomical model and the fluoroscopic image, and

(d) comparing a position of the implant in the patient to a position of a virtual implant of the virtual anatomical model based on the synchronized virtual anatomical model and the at least one image; and

(e) repeating steps (a)-(d) to determine that the implant is positioned at an acceptable location in the patient based on the comparison, wherein the acceptable location is a maximum acceptable distance from a target location for the implant.

11. The system according to claim 10 ,

wherein synchronizing the virtual anatomical model and the at least one image includes manipulating the virtual anatomical model and/or the at least one image of a pre-operative plan according to a best fit routine, and

wherein steps (a)-(d) are repeated using images of the patient showing the implant at another location.

12. The system according to claim 11 , wherein manipulating the virtual anatomical model and/or the at least one image includes at least one of zooming, stretching, or rotating the virtual anatomical model to align anatomical features in the virtual anatomical model with corresponding anatomical features in the at least one image.

13. The system according to claim 11 , wherein manipulating the virtual anatomical model and/or the at least one image includes at least one of zooming, stretching, or rotating the at least one image to align the at least one image with the virtual anatomical model.

14. The system according to claim 10 , wherein the process further comprises:

determining the acceptable location in the patient using a machine learning (ML) engine, wherein the acceptable location is inputted by a user.

15. The system according to claim 10 , wherein the process further comprises:

sequentially receiving images of the patient to repeatedly perform steps (a)-(d) using a respective one of the images.

16. The system according to claim 10 , wherein the process further comprises:

retrieving a patient-specific surgical plan for the patient;

generating instructions for moving the implant toward a target location in the patient-specific surgical plan; and

causing the instructions to be intra-operatively outputted to assist with repositioning the implant.

17. A system comprising:

one or more processors; and

one or more memories storing instructions that, when executed by the one or more processors, cause the system to perform a process comprising:

(a) obtaining at least one image of an implant located in a patient;

(b) identifying the implant in the at least one image;

(c) synchronizing a virtual anatomical model and the at least one image;

(d) comparing a position of the implant in the patient to a position of a virtual implant of the virtual anatomical model based on the synchronized virtual anatomical model and the at least one image; and

(e) repeating steps (a)-(d) to determine that the implant is positioned at an acceptable location in the patient based on the comparison;

wherein the process further comprises

obtaining type of implant information for the implant;

selecting an implant-type deviation analysis based on the type of implant information;

generating deviation annotation for positioning the implant that has been inserted into the patient based on the implant-type deviation analysis; and

displaying the deviation annotation via an electronic display.

18. The system according to claim 17 , wherein the implant-type deviation analysis includes at least one of:

an interbody cage analysis for deviation annotation of vertebral endplate-based positioning for fusion,

an artificial disk analysis for deviation annotation of vertebral endplate-based positioning for joint articulation, or

a screw and rod fusion system analysis for vertebral body-based positioning for fusion.

19. A non-transitory computer-readable medium storing instructions that, when executed by a computing system, cause the computing system to perform operations comprising:

(a) obtaining at least one image of an implant located in a patient, wherein the at least one image is a fluoroscopic image,

(b) identifying the implant in the at least one image;

(c) synchronizing a virtual anatomical model and the at least one image, wherein the synchronization includes performing an anatomical alignment between the virtual anatomical model and the fluoroscopic image, and

(d) comparing a position of the implant in the patient to a position of a virtual implant of the virtual anatomical model based on the synchronized virtual anatomical model and the at least one image; and

(e) repeating steps (a)-(d) to determine that the implant is positioned at an acceptable location in the patient based on the comparison, wherein the acceptable location is a maximum acceptable distance from a target location for the implant.

20. The non-transitory computer-readable medium of claim 19 ,

wherein synchronizing the virtual anatomical model and the at least one image includes manipulating the virtual anatomical model and/or the at least one image of a pre-operative plan according to a best fit routine, and

wherein steps (a)-(d) are repeated using images of the patient showing the implant at another location.

21. The non-transitory computer-readable medium of claim 20 , wherein manipulating the virtual anatomical model and/or the at least one image includes at least one of zooming, stretching, or rotating the virtual anatomical model to align anatomical features in the virtual anatomical model with corresponding anatomical features in the at least one image.

22. The non-transitory computer-readable medium of claim 20 , wherein manipulating the virtual anatomical model and/or the at least one image includes at least one of zooming, stretching, or rotating the at least one image to align the at least one image with the virtual anatomical model.

23. The non-transitory computer-readable medium of claim 19 , wherein the operations further comprise:

retrieving a patient-specific surgical plan for the patient;

generating instructions for moving the implant toward a target location in the patient-specific surgical plan; and

causing the instructions to be intra-operatively outputted to assist with repositioning the implant.

24. A non-transitory computer-readable medium storing instructions that, when executed by a computing system, cause the computing system to perform operations comprising:

(a) obtaining at least one image of an implant located in a patient;

(b) identifying the implant in the at least one image;

(c) synchronizing a virtual anatomical model and the at least one image;

(d) comparing a position of the implant in the patient to a position of a virtual implant of the virtual anatomical model based on the synchronized virtual anatomical model and the at least one image; and

repeating steps (a)-(d) to determine that the implant is positioned at an acceptable location in the patient based on the comparison,

wherein the operations further comprise:

obtaining type of implant information for the implant;

selecting an implant-type deviation analysis based on the type of implant information;

generating deviation annotation for positioning the implant that has been inserted into the patient based on the implant-type deviation analysis; and

displaying the deviation annotation via an electronic display, wherein the implant-type deviation analysis includes at least one of:

an interbody cage analysis for deviation annotation of vertebral endplate-based positioning for fusion,

an artificial disk analysis for deviation annotation of vertebral endplate-based positioning for joint articulation, or

a screw and rod fusion system analysis for vertebral body-based positioning for fusion.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 10, 2025
From: CASEY, NIALL PATRICK; NICOLAU, RODRIGO JUNQUEIRA; HUSSAIN, SYED SHARIQ; PENNAL, JEFFERY; CHEN, MATTHEW
To: CARLSMED, INC.
Reel/Frame 070171/0862 →
Continuity (2)
Provisional Application 63443676 · Feb 6, 2023
Related Publication 20240261029A1 · Aug 8, 2024
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