Surgical systems with intra-operative 3D scanners and surgical methods using the same

Inventors

Meftah, MortezaBenimovich, Irina

Assignees

Caira Surgical Corp

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Publication Number

US-11351007-B1

Patent

Publication Date

2022-06-07

Expiration Date


Abstract

Aspects of the present disclosure include surgical systems that provide a cost-effective, accurate, and efficient system for performing surgical procedures. In one aspect of the disclosure, a surgical system utilizes an intra-operative 3D scanner that can be used to determine anatomical landmarks and calculate surgical positions based on such anatomical landmarks. In some examples, aspects of the present disclosure also include providing guidance information for guiding the placement of a surgical instrument according to the calculated surgical positions.

Core Innovation

The invention relates to an open-platform arthroplasty surgical system and method that performs intra-operative scanning of exposed bone surface and cartilage surface in an anatomical region of interest. The method uses an intra-operative 3D scanner to scan selected landmarks of at least one of the bone or cartilage surfaces and generates a 3D image from data generated during scanning. The processor identifies one or more anatomical landmarks in the 3D image on at least one of the bone and cartilage surfaces.

The method automatically registers the identified anatomical landmarks to at least one of pre-operative images or a machine learning database of images. Based on the identified anatomical landmarks, the processor calculates a plurality of surgical positions and generates guidance information for guiding the surgical procedure. The guidance information is used for positioning a bone cutting jig proximate the bone surface.

The bone cutting jig is fixed to a bone proximate the bone surface. An image capture device captures a plurality of images of the bone cutting jig provisionally fixed to the bone as the bone cutting jig and the region of anatomical interest are moved, and the processor determines positions of the bone cutting jig from the plurality of images. From the determined positions, the processor calculates a mechanical axis of a bone.

Claims Coverage

The disclosed claims include one independent claim directed to an arthroplasty method and multiple dependent claims refining scanner types, landmark identification, guidance modalities, knee-specific steps, and excluding tracker-fixed-to-bone use. The independent claim covers a full workflow from intra-operative landmark scanning and 3D image generation through automatic registration, surgical position calculation, guidance generation, bone cutting jig placement and fixing, image capture for jig position determination, and mechanical axis calculation.

Intra-operative 3D scanning and 3D image generation for anatomical landmarks

exposing a bone surface and a cartilage surface in an anatomical region of interest; scanning intraoperatively, with an intra-operative 3D scanner, selected landmarks of at least one of the bone or cartilage surfaces; generating, with a processor, from data generated by the 3D scanner during the scanning step, a 3D image; identifying, with the processor, in the 3D image, one or more anatomical landmarks on at least one of the bone and cartilage surfaces

Automatic landmark registration to pre-operative images or a machine learning database

automatically registering, with the processor, the one or more anatomical landmarks to at least one of pre-operative images or a machine learning database of images

Surgical position calculation and guidance information generation

calculating, with the processor, according to the identified anatomical landmarks, a plurality of surgical positions; generating, with the processor, guidance information, according to the surgical positions, for guiding the surgical procedure

Guidance-informed bone cutting jig positioning, fixation, and jig position determination

positioning a bone cutting jig proximate the bone surface, wherein the positioning includes use of the guidance information; fixing the bone cutting jig to a bone proximate the bone surface; capturing, with an image capture device, a plurality of images of the bone cutting jig provisionally fixed to the bone as the bone cutting jig and region of anatomical interest are moved; determining, with the processor, positions of the bone cutting jig from the plurality of images

Mechanical axis calculation from determined bone cutting jig positions

calculating, with the processor, from the determined positions, a mechanical axis of a bone

Overall, the independent claim centers on automatically registering intra-operatively identified anatomical landmarks from a 3D image to pre-operative images or a machine learning database, calculating surgical positions and guidance information, using that guidance for bone cutting jig positioning and fixation, capturing images during movement to determine jig positions, and calculating a mechanical axis from the determined jig positions. Dependent claims refine the 3D scanner to laser/white light/blue light, specify machine learning database comparison for landmark identification, add hologram projection modalities, narrow to knee-specific cut and soft-tissue balance determination using varus/valgus imaging, and exclude trackers fixed to bone for data collection, calibration, or navigation.

Stated Advantages

Tracker-free navigation and reduced reliance on external trackers.

Improved accuracy/efficiency.

Reduced reliance on pre-operative CT.

Reduced cost.

Documented Applications

Arthroplasty surgical procedure, including orthopedic procedures such as knee replacement (knee-specific examples include proximal tibia and distal femoral cuts and femur mechanical axis and tibia mechanical axis concepts).

Open-platform orthopedic surgical system for arthroplasty using intra-operative scanning and projection-style guidance modalities.

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