Granted Patent B1

US 12,514,644 · App. 19/015,447 · Granted Jan 6, 2026

Inventors: Niall Patrick Casey (Carlsbad, CA); Sarah Jauregui (San Diego, CA); Jeremy Winston (San Diego, CA)

Assignee: Carlsmed, Inc.

A61B34/10A61B34/25A61F2/44A61B2034/105A61B2034/107A61B2034/108

Abstract

Claims (106)

1 . A method for treating a spinal deformity, the method comprising:

obtaining a digital model of anatomy of a patient and anatomical correction information;

selecting an implant system with a plurality of patient-specific anchor assemblies and a patient-specific rod configured to fit and connect together in a predetermined relative orientation for achieving an anatomical correction for a spine of the patient based on the anatomical correction information and one or more fitting relationships between two or more of the plurality of patient-specific anchor assemblies and the patient-specific rod, wherein each of the plurality of patient-specific anchor assemblies includes:

a rod holder,

a rod retainer operable to couple the rod holder to the patient-specific rod, and

a bone anchor including:

a seating member couplable to the rod holder in only one predetermined configuration based on the predetermined relative orientation, and

a threaded shaft fixedly coupled to the seating member in only one configuration based on the predetermined relative orientation; and

determining a target implant position of the patient-specific rod;

for each of the plurality of patient-specific anchor assemblies,

selecting a set of parameters for designing the patient-specific anchor assembly based on the digital model and the anatomical correction information, wherein the set of parameters includes a patient-specific trajectory for each of the threaded shaft relative to a corresponding one of the seating members;

determining the trajectory of each of the threaded shaft relative to the patient-specific rod based on the target implant position of the patient-specific rod and the anatomy of the patient such that the rod holders and the seating members cooperate to lock the threaded shafts at different fixed trajectories relative to the patient-specific rod; and

generating an implant designer graphical user interface (GUI) for displaying the set of parameters, a planned spinal anatomy of the patient, and a model of the patient-specific rod and the plurality of patient-specific anchor assemblies positioned along the planned spinal anatomy to achieve the anatomical correction information.

2 . The method of claim 1 , further comprising:

determining the one or more fitting relationships between the two or more of the plurality of patient-specific anchor assemblies; and

modifying at least one model of the two or more of the plurality of patient-specific anchor assemblies based on the one or more fitting relationships.

3 . The method of claim 1 , further comprising generating a model of the implant system having the plurality of patient-specific anchor assemblies fitting together to achieve the anatomical correction of the patient.

4 . The method of claim 1 , further comprising:

identifying an interface between two of the plurality of patient-specific anchor assemblies;

selecting a fitting routine based on the interface; and

modifying, using the fitting routine, at least one of the two of the plurality of patient-specific anchor assemblies implants to achieve a threshold fit.

5 . The method of claim 4 , further comprising modifying only portions of at least one of the two of the plurality of patient-specific anchor assemblies positioned outside of bony anatomy.

6 . The method of claim 1 , further comprising:

dynamically modifying a model of the implant system by

modifying a first one of the plurality of patient-specific anchor assemblies according to a modified value for the first one of the plurality of patient-specific anchor assemblies;

modifying a second one of the plurality of patient-specific anchor assemblies to fit with the first one of the plurality of patient-specific anchor assemblies; and

generating a viewable image of the modified model of the implant system with the modified first one and modified second one of the plurality of patient-specific anchor assemblies.

7 . The method of claim 6 , further comprising

simulating, using a surgery manager system, a predicted corrected anatomy of the patient based on a simulated implantation of the implant system using a virtual model representing anatomy of the patient;

generating, using the surgery manager system, surgical feedback for assisting an individual with the modified model of the implant system in a surgical procedure, wherein the surgical feedback is based on the simulated implantation; and

sending, from the surgery manager system, a viewable surgical plan for viewing by the individual.

8 . The method of claim 7 , further comprising:

determining whether a threshold amount of patient data of the patient is available for intra-operatively simulating implantation of an intra-operatively modified implant to meet a confidence score, wherein intra-operative surgical feedback is sent after determining that the threshold amount of patient data of the patient is available.

9 . The method of claim 7 , further comprising:

generating a measurable virtual model of anatomy of the patient based on simulated implantation of the implant system;

selecting at least one measuring algorithm from a set of measuring algorithms based on a target outcome for a planned surgical procedure; and

measuring one or more planned metrics for evaluating the planned surgical procedure using the at least one measuring algorithm and the measurable virtual model of anatomy of the patient, wherein the surgical feedback includes the one or more planned metrics.

10 . The method of claim 1 , wherein the method further comprises:

modifying a curvature of the patient-specific rod or a length of the patient-specific rod.

11 . The method of claim 1 , further comprising:

determining whether the implant system meets a plan generation threshold; and

in response to the implant system meeting the plan generation threshold, generating a surgical plan based on usage of the implant system.

12 . The method of claim 1 , further comprising:

linking surgery manager system to an interactive surgical plan displayable by a user device, wherein the surgery manager system stores parametric information of the digital model; and

synchronizing, using the surgery manager system, the interactive surgical plan and a simulator module that receives values to display new simulation data generated by the simulator module for concurrently evaluating the plurality of patient-specific anchor assemblies.

13 . A method for treating a spinal deformity, the method comprising:

selecting a design process protocol for designing a patient-specific implant system based on a target correction for a patient;

selecting an implant system with a plurality of patient-specific anchor assemblies and a patient-specific rod that are configured to fit and connect together in a predetermined relative orientation for achieving an anatomical correction for a spine of the patient based on one or more fitting relationships between two or more of the plurality of patient-specific anchor assemblies, wherein each of the patient-specific anchor assemblies includes:

a rod holder,

a rod retainer operable to couple the rod holder to the patient-specific rod, and

a bone anchor including:

a seating member couplable to the rod holder in only one predetermined configuration based on the predetermined relative orientation, and

a threaded shaft fixedly coupled to the seating member in only one configuration based on the predetermined relative orientation, and

determining a target implant position of the patient-specific rod;

for each of a plurality of patient-specific anchor assemblies of the patient-specific implant system;

selecting a set of parameters for designing each of the plurality of patient-specific anchor assemblies based on patient anatomy and the target correction for a region of the spine the patient, wherein the set of parameters includes a patient-specific trajectory for each of the threaded shaft relative to a corresponding one of the seating members,

determining a trajectory of each of the threaded shaft relative to the patient-specific rod based on the target implant position of the patient-specific rod and the anatomy of the patient such that the rod holder and the seating member in the only one predetermined configuration to lock threaded shafts at different fixed trajectories relative to the patient-specific rod,

generating an implant designer graphical user interface (GUI) for displaying the set of parameters for the design process protocol, values for the respective parameters, and a planned anatomy of the patient, and

generating a design for each of the plurality of patient-specific anchor assemblies such that the plurality of patient-specific anchor assemblies cooperate to anatomical correction to the patient based on the target correction.

14 . The method of claim 13 , wherein

the target correction for the patient includes spinal realignment, and

the planned anatomy of the patient is represented by a virtual model of the patient anatomy of the patient with the target correction.

15 . The method of claim 13 , wherein the design process protocol is a user-controlled design protocol in which a user inputs the values or a machine learning process protocol in which a machine learning module generates the values.

16 . The method of claim 13 , wherein the design process protocol includes a virtual modeling protocol for generating a model of anatomy of the patient and a parametric modeling process for generating a parametric model of the patient-specific implant system.

17 . The method of claim 16 , further comprising:

virtually positioning the parametric model of the patient-specific implant system along the model of anatomy of the patient; and

generating a viewable data illustrating the patient-specific implant system virtually positioned in the patient.

18 . The method of claim 13 , further comprising:

obtaining measurements using a model of the patient anatomy; and

generating a parametric model of the patient-specific implant system based on the measurements.

19 . The method of claim 13 , further comprising:

generating a parametric model of the patient-specific implant system;

modifying the parametric model based on a modification to one or more of the values; and

determining whether the modified parametric model meets at least one design criteria.

20 . The method of claim 19 , wherein the at least one design criteria is inputted by a user.

21 . The method of claim 19 , wherein the at least one design criteria includes a target correction to the patient.

22 . The method of claim 13 , further comprising generating a manufacturing design for each of the plurality of patient-specific anchor assemblies for individually manufacturing each of the plurality of patient-specific anchor assemblies.

23 . A method for treating a spinal deformity, the method comprising:

obtaining a digital model of anatomy of a patient and an anatomical correction information;

selecting an implant system with a plurality of patient-specific anchor assemblies and a patient-specific rod that are configured to fit and couple together in a predetermined relative orientation to achieve a target anatomical correction for a spine of the patient when implanted based the anatomical correction information and fitting relationships between two or more of the plurality of patient-specific anchor assemblies and the patient-specific rod, wherein each of the anchor assemblies includes;

a rod holder,

a rod retainer operable to couple the rod holder to the patient-specific rod, and

a bone anchor including:

a seating member couplable to the rod holder in only one predetermined configuration based on the predetermined relative orientation, and

a threaded shaft fixedly coupled to the seating member in only one configuration based on the predetermined relative orientation; and

for each of the plurality of patient-specific anchor assemblies, selecting a set of parameters for designing each of the plurality of patient-specific anchor assemblies based on the digital model and the target anatomical correction, wherein the set of parameters includes a patient-specific trajectory for each of the threaded shaft relative to a corresponding one of the seating members; and

determining a trajectory of each the threaded shaft relative to the patient-specific rod based on a target implant position of the patient-specific rod and the anatomy of the patient such that the rod holders and the seating members couple together to lock the threaded shafts at different fixed trajectories relative to the patient-specific rod,

generating an implant designer graphical user interface (GUI) for displaying the set of parameters, values for the respective parameters, a planned spinal anatomy of the patient, and a model of each of the plurality of patient-specific anchor assemblies digitally positioned along the planned spinal anatomy, wherein the model of each of the plurality of patient-specific anchor assemblies represents the values.

24 . The method of claim 23 , further comprising virtually fitting the implant system to the patient by:

determining one or more fitting relationships between two or more of the plurality of patient-specific anchor assemblies; and

modifying at least one model of the two or more of the plurality of patient-specific anchor assemblies based on the one or more fitting relationships.

25 . A method for treating a spinal deformity, the method comprising:

obtaining a digital model of anatomy of a patient and an anatomical correction information;

selecting a spinal implant system configured to extend across multiple levels of a spine of the patient, wherein the spinal implant system includes a plurality of patient-specific anchor assemblies and a patient-specific rod configured to be coupled together in a predetermined relative orientation to achieve a target anatomical correction in the patient based on the anatomical correction information and fitting relationships between plurality of the patient-specific anchor assemblies and the patient-specific rod; and

wherein each of the anchor assemblies includes:

a rod holder,

a rod retainer operable to couple the rod holder to the patient-specific rod, and

a bone anchor including:

a seating member couplable to the rod holder in only one predetermined configuration based on the predetermined relative orientation, and

a threaded shaft fixedly coupled to the seating member in only one configuration based on the predetermined relative orientation;

for each of patient-specific anchor assemblies, selecting a set of parameters for designing the respective each of patient-specific anchor assemblies based on the digital model and the target anatomical correction, wherein the set of parameters includes a patient-specific trajectory for each of the threaded shaft relative to a corresponding one of the seating members;

determining the trajectory of the threaded shaft relative to the patient-specific rod based on a target implant position of the patient-specific rod and the anatomy of the patient such that the rod holders and the seating members cooperate to lock the threaded shafts at different fixed trajectories relative to the patient-specific rod; and

generating an implant designer graphical user interface for displaying the set of parameters, values for the respective parameters, a planned spinal anatomy of the patient and a representation of each of the patient-specific anchor assemblies digitally positioned along the planned spinal anatomy to achieve the target anatomical correction.

26 . The method of claim 25 , wherein

the spinal implant system is a posterior fixation system, and

the plurality of patient-specific anchor assemblies includes two custom spinal rods configured to extend across the multiple levels, wherein the two custom spinal rods have different configurations.

Assignments (1)

References Cited (383)