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

Inventors

Casey, Niall Patrick • Nicolau, Rodrigo Junqueira • Hussain, Syed Shariq • Pennal, Jeffery • Chen, Matthew

Assignees

Carlsmed Inc

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Publication Number

US-12274510-B2

Patent

Publication Date

2025-04-15

Expiration Date


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.

Core Innovation

The invention provides a patient-specific surgical workflow and system in which at least one image of an implant located in a patient is obtained as a fluoroscopic image. The implant is identified in the at least one image, and a virtual anatomical model is synchronized with the at least one image through performing an anatomical alignment between the virtual anatomical model and the fluoroscopic image. A position of the implant in the patient is then compared 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.

The workflow repeats obtaining and analyzing additional images by repeating steps (a)-(d) to determine that the implant is positioned at an acceptable location in the patient. The acceptable location is determined based on the comparison, wherein the acceptable location is a maximum acceptable distance from a target location for the implant. The workflow also supports synchronizing by manipulating the virtual anatomical model and/or the at least one image, including performing a best fit routine and zooming, stretching, or rotating to align anatomical features.

In addition to position comparison, the invention incorporates implant-type-specific deviation annotation. Type of implant information is obtained for the implant, an implant-type deviation analysis is selected based on the type of implant information, deviation annotation is generated for positioning the implant that has been inserted into the patient, and the deviation annotation is displayed via an electronic display. The implant-type deviation analysis includes at least one of an interbody cage analysis, an artificial disk analysis, or a screw and rod fusion system analysis, tied to specified vertebral endplate-based or vertebral body-based positioning contexts.

Claims Coverage

The claim coverage includes five independent claim sets covering fluoroscopy-based implant position verification using synchronized virtual anatomical modeling and a maximum acceptable-distance criterion, a system implementation of that method, implant-type deviation annotation selection and electronic display, and two non-transitory computer-readable medium claims for those workflows.

Fluoroscopic implant position verification with synchronized virtual anatomical model

Synchronizing a virtual anatomical model and the fluoroscopic image via anatomical alignment; comparing a position of the implant to a position of a virtual implant based on the synchronized virtual anatomical model and the at least one image; and repeating to determine the implant is positioned at an acceptable location where the acceptable location is a maximum acceptable distance from a target location for the implant.

System implementation for maximum-distance implant placement determination

Obtaining at least one fluoroscopic image, identifying the implant, synchronizing the virtual anatomical model with anatomical alignment, comparing the implant position to a virtual implant position, and repeating steps (a)-(d) to determine the implant is positioned at an acceptable location based on the comparison where the acceptable location is a maximum acceptable distance from a target location for the implant.

Implant-type deviation analysis with deviation annotation display

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 based on the implant-type deviation analysis; and displaying the deviation annotation via an electronic display.

Non-transitory computer-readable medium for maximum-distance implant placement verification

Obtaining at least one fluoroscopic image of an implant in a patient; identifying the implant; synchronizing a virtual anatomical model and the fluoroscopic image via anatomical alignment; comparing a position of the implant to a position of a virtual implant based on the synchronized virtual anatomical model and the at least one image; and repeating to determine that the implant is positioned at an acceptable location where the acceptable location is a maximum acceptable distance from a target location for the implant.

Non-transitory computer-readable medium with implant-type-specific deviation annotation

Obtaining type of implant information; selecting an implant-type deviation analysis based on the type of implant information; generating deviation annotation for positioning the implant inserted into the patient based on the implant-type deviation analysis; 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.

The claims center on verifying implant positioning using fluoroscopic images synchronized to a virtual anatomical model with anatomical alignment and comparing the implant position to a virtual implant position against a maximum acceptable-distance criterion, with additional coverage for implant-type-specific deviation analysis that generates deviation annotation and displays it on an electronic display.

Stated Advantages

Documented Applications

No documented applications found

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