Carlsmed, Inc.

Systems and methods for verifying the quality of patient specific implants are disclosed. A system can generate implant data, such as design files or fabrication instructions, for manufacturing the implant. The system can manage access to the implant data based on authentication levels. Based on the determined authentication level of the user requesting access to the implant data, the system can permit the user to access some or all of the implant data. The system can perform a quality check on a manufactured implant by scanning the manufactured implant to identify any errors in the manufactured implant.

Systems and methods for designing and implementing patient-specific surgical procedures and/or medical devices are disclosed. In some embodiments, the system automatically measures and analyzes one or more parameters from images of the human to, for example, assist with diagnosis and/or treatment. The automated measurements can measure parameters between patients and/or physicians to generate historical data suitable for training machine learning systems. Pre-operative images can be analyzed to determine spinal-pelvic parameters for diagnosing patients, generating treatment plans, and/or assessing efficacy of treatment. Intra-operative images can be analyzed to determine spinal-pelvic parameters for interoperative simulations.

The present technology includes patient-specific spinal fusion devices, which may include an interbody implant that is designed to be positioned within a disc space between two vertebral bodies and one or more fixation elements that can anchor the interbody implant to the vertebral bodies. The fusion devices include one or more retention mechanisms for retaining the fixation elements within corresponding lumens or bore holes extending through the interbody implant. Methods for designing and manufacturing patient-specific spinal fusion devices are also described herein.

The present technology provides patient-specific vertebral implants. The implants can include a cage having a geometry contoured to mate with an inferior surface of a superior vertebra and a superior surface of an inferior vertebra at a first target position. The implants can also include a plate having a geometry contoured to mate with an identified anatomical structure at a second target position. The cage and plate can be coupled in a predetermined three-dimensional orientation that simultaneously permits the cage to occupy the first target position and the plate to occupy the second target position when the implant is implanted.

The present technology includes inserter instruments for use with medical implant procedures. The inserter instruments can include features that are expected to enable the inserter instruments to be accurately registered with off-the-shelf or conventional surgical navigation systems. For example, the inserter instruments can include a retractable implant coupling element. The retractable implant coupling element can be selectively transitioned between (a) a first configuration in which the implant coupling element extends past a distal end of a shaft of the inserter, and (b) a second configuration in which the implant coupling element is retracted inside the shaft such that it is flush with, or positioned proximally of, the distal end of the shaft.

An interbody implant system for use in the spine includes a base comprising two or more bone contacting surfaces, at least one recess in at least one of the two or more bone contacting surfaces, the recess configured for containing a tooth, a deployable tooth to provide fixation between the base and the anatomy of a subject, a break-away bridge between the tooth and the base for providing a first relative position between the tooth and the base, and a locking mechanism for providing a second relative position between the tooth and the base.

Systems and methods for designing patient-specific orthopedic implants. The systems and methods can include automated collection protocols for available third-party data to use to generate surgical plans or patient-specific orthopedic implant designs. The system can identify triggers for collecting third-party data. The system can determine a confidence score for the collected third-party data based on the type of data, the source of the data, and the similarity of the data to patient data. The system can select parameters in the third-party data to integrate into designing a patient-specific implant or patient treatment.

A system and computer-implemented method for manufacturing an orthopedic implant involves segmenting features in an image of anatomy. Anatomic elements can be isolated. Spatial relationships between the isolated anatomic elements can be manipulated. Negative space between anatomic elements is mapped before and/or after manipulating the spatial relationships. At least a portion of the negative space can be filled with a virtual implant. The virtual implant can be used to design and manufacture a physical implant.

Systems and methods for assisting a surgeon with implant during a surgery are disclosed. A method includes defining areas of interest in diagnostic data of a patient and defining an implant type. Post defining the areas of interest, salient points are determined for the areas of interest. Successively, an XZ angle, an XY angle, and a position entry point for an implant are determined based on the salient points of the areas of interest. In spinal procedures, a maximum screw diameter and a length of the spinal screw are successively determined based on the salient points. Based on determined length and diameter, a spinal screw and a matching screw guide is determined. Thereafter, the spinal screw and the screw guide is printed using a Three-Dimensional (3D) printer. Such printed spinal screw and screw guide could be used by the surgeon during the spinal surgery.

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 identify if the patient-specific implant was intra-operatively modified.