US-20260123996-A1 - INTRA-OPERATIVELY MODIFIED IMPLANTS FOR SURGICAL PROCEDURES

US20260123996A1US 20260123996 A1US20260123996 A1US 20260123996A1US-20260123996-A1

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

Inventors

Niall Patrick Casey
Michael J. Cordonnier

Assignees

CARLSMED, INC.

Dates

Publication Date: 20260507
Application Date: 20251105

Claims (20)

1 . An intra-operative surgical system comprising: an intra-operatively modified spinal rod including a reshaped portion matching a target configuration displayed by a user device; and a reshaping tool including a channel for receiving a portion of the intra-operatively modified spinal rod, a pair of elongated handles, and a plurality of arcuate contactors configured to press against the intra-operatively modified spinal rod positioned in the channel to reshape the intra-operatively modified spinal rod.
2 . The intra-operative surgical system of claim 1 , further comprising a plurality of screw assemblies configured to be coupled to the intra-operatively modified spinal rod, wherein each of the plurality of screw assemblies includes a bone screw; and a graphical user interface displayed by the user device, wherein the graphical user interface includes user inputs for managing acquisition of image data of the intra-operatively modified spinal rod and viewing a surgical plan showing the intra-operatively modified spinal rod implanted in a subject.
3 . A method for assisting a surgical procedure performed on a patient, the method comprising: receiving a notification of at least one intra-operative modification of an intra-operatively modified implant; receiving implant data captured by a user device associated with an individual, wherein the implant data shows the intra-operatively modified implant; intra-operatively simulating, using an interoperative surgery manager system, a predicted corrected anatomy of the patient based on a simulated implantation of the intra-operatively modified implant using a virtual model representing anatomy of the patient; generating, using the interoperative surgery manager system, intra-operative surgical feedback for assisting the individual with the intra-operatively modified implant in the surgical procedure, wherein the intra-operative surgical feedback is based on the simulated implantation; and sending, from the interoperative surgery manager system, the intra-operative surgical feedback for viewing by the individual during the surgical procedure.
4 . The method of claim 3 , further comprising: determining whether a threshold amount of patient data of the patient is available for intra-operatively simulating implantation of the intra-operatively modified implant to meet a confidence score, wherein the intra-operative surgical feedback is sent after determining that the threshold amount of patient data of the patient is available.
5 . The method of claim 3 , further comprising: identifying at least one modified feature of the intra-operatively modified implant; and determining a predicted effect to the patient caused by the at least one modified feature, wherein the intra-operative surgical feedback includes feedback that characterizes the predicted effect.
6 . The method of claim 3 , further comprising: intra-operatively modifying a curvature of a rod, modifying an endplate of an intervertebral cage, or replacing a bone screw to produce the intra-operatively modified implant.
7 . The method of claim 3 , wherein the implant data includes at least one of one or more images of the intra-operatively modified implant, physician inputted modification, or one or more images of the patient showing the intra-operatively modified implant in the patient.
8 . The method of claim 3 , further comprising: determining whether the intra-operatively modified implant meets a plan generation threshold; and in response to the intra-operatively modified implant meeting the plan generation threshold, generating a surgical plan based on usage of the intra-operatively modified implant.
9 . The method of claim 3 , further comprising: linking the interoperative surgery manager system to an interactive surgical plan displayable by the user device; and synchronizing, using the interoperative surgery manager system, the interactive surgical plan and a simulator module that receives the implant data to display new simulation data generated by the simulator module for evaluating the intra-operatively modified implant.
10 . The method of claim 3 , further comprising: generating a measurable virtual model of anatomy of the patient based on the simulated implantation; selecting at least one measuring algorithm from a set of measuring algorithms based on a target outcome for the surgical procedure; and measuring one or more planned metrics for evaluating the surgical procedure using the at least one measuring algorithm and the measurable virtual model of anatomy of the patient, wherein the intra-operative surgical feedback includes the one or more planned metrics.
11 . The method of claim 3 , further comprising: determining additional patient data is needed or at least one of modifying the virtual model or generating a new virtual model of the patient; and sending a request for the additional patient data for viewing at a surgery site.
12 . The method of claim 3 , further comprising: determining, based on the simulated implantation, whether to modify the virtual model or to generate a new virtual model of the patient based on the simulated implantation; and in response to determining to modify the virtual model or to generate the new virtual model, determining additional patient data is needed for at least one of modifying the virtual model or generating the new virtual model of the patient, and sending an inquiry for the additional patient data.
13 . The method of claim 3 , further comprising: determining, based on the implant data, that anatomy of the patient was modified outside of a pre-operative plan; and determining at least one adjustment to the intra-operatively modified implant based on the modified anatomy.
14 . 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 for assisting a surgical procedure performed on a patient, the process comprising: receiving a notification of at least one intra-operative modification of an intra-operatively modified implant; receiving implant data captured by a user device associated with an individual, wherein the implant data shows the intra-operatively modified implant; intra-operatively simulating, using an interoperative surgery manager system, a predicted corrected anatomy of the patient based on a simulated implantation of the intra-operatively modified implant using a virtual model representing anatomy of the patient; generating, using the interoperative surgery manager system, intra-operative surgical feedback for assisting the individual with the intra-operatively modified implant in the surgical procedure, wherein the intra-operative surgical feedback is based on the simulated implantation; and sending, from the interoperative surgery manager system, the intra-operative surgical feedback for viewing by the individual during the surgical procedure.
15 . The system of claim 14 , wherein the process further comprises: determining whether a threshold amount of patient data of the patient is available for intra-operatively simulating implantation of the intra-operatively modified implant to meet a confidence score, wherein the intra-operative surgical feedback is sent after determining that the threshold amount of patient data of the patient is available.
16 . The system of claim 14 , wherein the process further comprises: identifying at least one modified feature of the intra-operatively modified implant; and determining a predicted effect to the patient caused by the at least one modified feature, wherein the intra-operative surgical feedback includes feedback that characterizes the predicted effect.
17 . The system of claim 14 , wherein the process further comprises: intra-operatively modifying a curvature of a rod, modifying an endplate of an intervertebral cage, or replacing a bone screw to produce the intra-operatively modified implant.
18 . The system of claim 14 , wherein the implant data includes at least one of one or more images of the intra-operatively modified implant, physician inputted modification, or one or more images of the patient showing the intra-operatively modified implant in the patient.
19 . The system of claim 14 , wherein the process further comprises: determining whether the intra-operatively modified implant meets a plan generation threshold; and in response to the intra-operatively modified implant meeting the plan generation threshold, generating a surgical plan based on usage of the intra-operatively modified implant.
20 . The system of claim 14 , wherein the process further comprises: linking the interoperative surgery manager system to an interactive surgical plan displayable by the user device; and synchronizing, using the interoperative surgery manager system, the interactive surgical plan and a simulator module that receives the implant data to display new simulation data generated by the simulator module for evaluating the intra-operatively modified implant.

Description

CROSS-REFERENCE TO RELATED APPLICATION This application claims priority to and the benefit of U.S. Provisional Patent No. 63/717,251 , filed Nov. 6, 2024, which is incorporated by reference herein in its entirety. TECHNICAL FIELD The present disclosure is generally related to intra-operative surgical technology, and more particularly to intra-operatively modified implants, surgical kits, and systems and methods for providing intra-operative assistance for surgical procedures. BACKGROUND Numerous types of data associated with patient treatments and surgical interventions are available. To determine treatment protocols for a patient, physicians often rely on a subset of patient data available via the patient's medical record and historical outcome data. However, the amount of patient data and historical data may be limited, and the available data may not be correlated or relevant to the particular patient to be treated. Conventional technologies in the field of orthopedics may lack the capability to draw upon large data sets to generate and optimize patient-specific treatments (e.g., surgical interventions and/or implant designs) to achieve favorable treatment outcomes. Additionally, a surgery can often deviate from a surgical plan based on intra-operative modifications to medical instruments or implants. In some procedures, a physician may want to deviate from a surgical plan. Unfortunately, during a patient-specific treatment conventional surgery systems do not actively monitor and assess whether the treatment that deviates from the planned treatment and intraoperatively modified implants will achieve a targeted outcome. BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings illustrate various embodiments of systems, methods, and embodiments of various other aspects of the disclosure. Any person with ordinary skill in the art will appreciate that the illustrated element boundaries (e.g., boxes, groups of boxes, or other shapes) in the figures represent one example of the boundaries. It may be that in some examples one element may be designed as multiple elements or that multiple elements may be designed as one element. In some examples, an element shown as an internal component of one element may be implemented as an external component in another, and vice versa. Furthermore, elements may not be drawn to scale. Non-limiting and non-exhaustive descriptions are described with reference to the following drawings. The components in the figures are not necessarily to scale, emphasis instead being placed upon illustrating principles. FIG. 1 is a network connection diagram illustrating a system for providing patient-specific medical care, according to an embodiment. FIG. 2 illustrates a computing device suitable for use in connection with the system of FIG. 1, according to an embodiment. FIG. 3 is a flow diagram illustrating a method for providing patient-specific medical care, according to an embodiment. FIGS. 4A-4C illustrate exemplary data sets that may be used and/or generated in connection with the methods described herein, according to an embodiment. FIG. 4A illustrates a patient data set. FIG. 4B illustrates a plurality of reference patient data sets. FIG. 4C illustrates similarity scores and outcome scores for the reference patient data sets of FIG. 4B. FIG. 5 is a flow diagram illustrating another method for providing patient-specific medical care, according to an embodiment. FIGS. 6A and 6B are flow diagrams illustrating methods for providing confirmation of intra-operative positioning of surgical implants, according to an embodiment. FIGS. 7A-7D illustrate an exemplary patient data set that may be used and/or generated in connection with the methods described herein, according to an embodiment. FIGS. 8A and 8B illustrate an exemplary virtual model of a patient's spine that may be used and/or generated in connection with the methods described herein, according to an embodiment. FIGS. 9A-1-9B-2 illustrate an exemplary virtual model of a patient's spine in a pre-operative anatomical configuration and a corrected anatomical configuration. More specifically, FIGS. 9A-1 and 9A-2 illustrate the pre-operative anatomical configuration of the patient, and FIGS. 9B-1 and 9B-2 illustrate the corrected anatomical configuration. FIG. 10A illustrates an exemplary interactive surgical plan for a patient-specific surgical procedure, according to an embodiment. FIG. 10B illustrates pre-operative, plan, intra-operative, and post-operative images to allow for assessment of achievement of surgical goals, according to an embodiment. FIG. 10C illustrates pre-operative, plan, intra-operative, and post-operative images to allow for assessment of achievement of surgical goals, according to an embodiment. FIG. 10D illustrates images that are overlayed to reconcile the pre-operative, plan, intra-operative, and post-operative images to allow for assessment of achievement of surgical goals, according to an embodiment. FIG. 10E