# US 11,112,770 B2 · Systems and methods for assisting a surgeon and producing patient-specific medical devices

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- Number: US 11,112,770 B2
- Document ID: US11112770B2
- Status: Granted
- Kind: B2
- Application number: 16/242,877
- Filed: 2019-01-08
- Published: 2019-05-16
- Granted: 2021-09-07
- Earliest claimed: 2017-11-09
- Assignees: Carlsmed, Inc.
- Applicants: Carlsmed, Inc.
- Inventors: Jeffrey Roh; Justin Esterberg
- Web page: https://patentgrep.com/patent/US11112770B2

## CPC

- G05B 19/4099: Surface or curve machining, making three-dimensional [3D] objects, e.g. desktop manufacturing
- G16H 30/40: for processing medical images, e.g. editing
- G16H 50/20: for computer-aided diagnosis, e.g. based on medical expert systems
- G16H 50/50: for simulation or modelling of medical disorders
- G05B 2219/49007: Making, forming 3-D object, model, surface
- G05B: CONTROL OR REGULATING SYSTEMS IN GENERAL; FUNCTIONAL ELEMENTS OF SUCH SYSTEMS; MONITORING OR TESTING ARRANGEMENTS FOR SUCH SYSTEMS OR ELEMENTS (systems for controlling or regulating non-electric variables G05D; systems for regulating electric or magnetic variables G05F; control devices or systems insofar as characterised by mechanical features only G05G)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

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.

## Claims

### Claim 1

A non-transitory computer-readable storage medium storing instructions that, when executed by a computing system, cause the computing system to perform operations comprising:
receiving diagnostic data of a patient, the diagnostic data including image data of the patient's spine;
analyzing the diagnostic data to identify one or more spinal segments for a surgery to be performed;
using at least one trained machine learning model to design, based on the one or more areas of interests and/or the diagnostic data, a first patient-specific implant and a second patient-specific implant configured to be spaced apart from the first patient-specific implant when implanted at the one or more spinal segments, wherein designing the first patient-specific implant and the second patient-specific implant includes specifying a first configuration of the first patient-specific implant and a second configuration of the second-patient specific implant;
generating a virtual model of the first patient-specific implant and the second patient-specific implant; and
converting the virtual model into 3D fabrication data for manufacturing the first patient-specific implant and the second patient-specific implant.

### Claim 2 (depends on 1)

The computer-readable storage medium of claim 1, wherein the operations further comprise causing the 3D fabrication data to be sent to at least one manufacturing system configured to manufacture the first patient-specific implant and the second patient-specific implant.

### Claim 3 (depends on 1)

The computer-readable storage medium of claim 1, wherein the first patient-specific implant and/or the second patient specific implant includes at least one of a patient-specific cage, plate, or disk.

### Claim 4 (depends on 1)

The computer-readable storage medium of claim 1, wherein the operations further comprise generating patient-specific surgical information for performing the surgery, wherein the patient-specific surgical information includes position information for delivering the first patient-specific implant and the second patient-specific implant to a site within the patient.

### Claim 5 (depends on 1)

The computer-readable storage medium of claim 1, wherein the operations further comprise:
training the at least one machine learning model based on a set of patient data; and
generating the virtual model of the first patient-specific implant and the second patient-specific implant using another machine learning model.

### Claim 6 (depends on 1)

The computer-readable storage medium of claim 1, wherein the operations further comprise:
determining patient-specific surgical information for performing the surgery; and
performing one or more structural analyses based on the virtual model of the first patient-specific implant and the second patient-specific implant to determine additional patient-specific surgical information.

### Claim 7

A non-transitory computer-readable storage medium storing instructions that, when executed by a computing system, cause the computing system to perform operations comprising:
receiving diagnostic data of a patient;
analyzing the diagnostic data to identify a spinal segment for a surgery to be performed, the spinal segment including at least a first vertebral level and a second vertebral level;
using at least one trained machine learning model to design, based on the spinal segment and/or the diagnostic data, a first patient-specific implant configured to be implanted at the first vertebral level and a second patient-specific implant configured to be implanted at the second vertebral level, wherein
the first patient-specific implant includes a first patient-specific cage, plate, or disk,
the second patient-specific implant includes a second patient-specific cage, plate, or disk, and
the first patient-specific implant and the second patient-specific implant are configured to provide a target correction to the spinal segment when implanted in the patient;
generating a virtual model of the first patient-specific implant and the second patient-specific implant; and
converting the virtual model into 3D fabrication data for manufacturing the first patient-specific implant and the second patient-specific implant.

### Claim 8 (depends on 7)

The computer-readable storage medium of claim 7, wherein the first patient-specific implant includes a first patient-specific cage and wherein the second patient-specific implant includes a second patient-specific cage.

### Claim 9 (depends on 7)

The computer-readable storage medium of claim 7, wherein analyzing the diagnostic data includes:
segmenting the spinal segment; and
analyzing the segmented spinal segment to determine boundaries of the first vertebral level and the second vertebral level.

### Claim 10 (depends on 7)

The computer-readable storage medium of claim 7, wherein the operations further comprise:
receiving user feedback on the first patient specific implant and/or the second patient specific implant before converting the virtual model into 3D fabrication data; and
adjusting one or more characteristics of the first patient-specific implant and/or the second patient-specific implant based at least in part on the user feedback and before converting the model into 3D fabrication data.

### Claim 11 (depends on 7)

The computer-readable storage medium of claim 7, wherein the operations further comprise:
performing a finite element analysis on the virtual model of the first patient-specific implant and the second patient-specific implant; and
adjusting one or more characteristics the first patient-specific implant and/or the second patient-specific implant based on the finite element analysis and before converting the model into 3D fabrication data.

### Claim 12 (depends on 7)

The computer-readable storage medium of claim 7, wherein the virtual model is a first virtual model, the method further comprising:
generating a second virtual model based on the diagnostic data, the second virtual model including at least the spinal segment including the first vertebral level and the second vertebral level,
wherein analyzing the diagnostic data to identify a spinal segment for surgery includes analyzing the second virtual model.

### Claim 13 (depends on 12)

The computer-readable storage medium of claim 12, further comprising combining the first virtual model and the second virtual model to display a virtual representation of the first patient specific implant and the second patient specific implant implanted in the patient.

### Claim 14 (depends on 7)

The computer-readable storage medium of claim 7, wherein the at least one trained machine learning model includes a first trained machine learning model, and wherein analyzing the diagnostic data to identify the spinal segment for the surgery to be performed includes using at least a second trained machine learning model.

### Claim 15

A non-transitory computer-readable storage medium storing instructions that, when executed by a computing system, cause the computing system to perform operations comprising:
receiving diagnostic data of a patient;
analyzing the diagnostic data to identify a section of the patient's spine for surgical correction, the section of the patient's spine including at least a first vertebra and a second vertebra;
using at least one trained machine learning model to design, based on the identified section of the patient's spine and/or the diagnostic data, a first patient-specific implant configured to contact the first vertebra and a second patient-specific implant configured to contact the second vertebra, wherein designing the first patient-specific implant and the second patient-specific implant includes specifying a first configuration of the first patient-specific implant and a second configuration of the second-patient specific implant;
generating a virtual model of the first patient-specific implant and the second patient-specific implant; and
manufacturing the first patient-specific implant and the second patient-specific implant.

### Claim 16 (depends on 15)

The computer-readable storage medium of claim 15, wherein the first patient-specific implant includes at least one of a patient-specific cage, plate, rod, disk, guide, or screw, and wherein the second patient-specific implant includes at least one of a patient-specific cage, plate, rod, disk, guide, or screw.

### Claim 17 (depends on 15)

The computer-readable storage medium of claim 15, wherein analyzing the diagnostic data includes:
segmenting the identified section of the patient's spine; and
analyzing the segmented section to determine boundaries of the first vertebra and the second vertebra.

### Claim 18 (depends on 15)

The computer-readable storage medium of claim 15, wherein the operations further comprise:
receiving user feedback on the first patient specific implant and/or the second patient implant before manufacturing the first patient-specific implant and the second patient-specific implant; and
adjusting one or more characteristics of the first patient-specific implant and/or the second patient-specific implant based at least in part on the user feedback and before manufacturing the first patient-specific implant and the second patient-specific implant.

### Claim 19 (depends on 15)

The computer-readable storage medium of claim 15, wherein the operations further comprise:
performing a finite element analysis of the first patient-specific implant and the second patient-specific implant based on the virtual model; and
adjusting one or more characteristics the first patient-specific implant and/or the second patient-specific implant based on the finite element analysis and before manufacturing the first patient-specific implant and the second patient-specific implant.

### Claim 20 (depends on 15)

The computer-readable storage medium of claim 15, wherein the first patient-specific implant includes a first patient-specific cage, plate, or disk, and wherein the second patient-specific implant includes a second patient-specific cage, plate, or disk.

### Claim 21 (depends on 15)

The computer-readable storage medium of claim 15, wherein the virtual model is a first virtual model, the method further comprising:
generating a second virtual model of at least the spinal segment including the first vertebral level and the second vertebral level based on the diagnostic data,
wherein analyzing the diagnostic data to identify a spinal segment for surgery includes analyzing the second virtual model.

### Claim 22 (depends on 21)

The computer-readable storage medium of claim 21, further comprising combining the first virtual model and the second virtual model to display a virtual representation of the first patient specific implant and the second patient specific implant implanted in the patient.

### Claim 23 (depends on 15)

The computer-readable storage medium of claim 15, wherein the at least one trained machine learning model includes a first trained machine learning model, and wherein analyzing the diagnostic data to identify the spinal segment for the surgery to be performed includes using at least a second trained machine learning model.