# US 12,004,814 B2 · Systems, methods, and devices for developing patient-specific spinal treatments, operations, and procedures

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- Number: US 12,004,814 B2
- Document ID: US12004814B2
- Status: Granted
- Kind: B2
- Application number: 17/496,222
- Filed: 2021-10-07
- Published: 2022-02-03
- Granted: 2024-06-11
- Earliest claimed: 2017-04-21
- Assignees: Medicrea International
- Applicants: Medicrea International
- Inventors: David N. Ryan; Denys Sournac; Thomas Mosnier; Christophe X. Javelot; Agathe Senac; Celine Augagneur
- Web page: https://patentgrep.com/patent/US12004814B2

## CPC

- A61B 34/10: Computer-aided planning, simulation or modelling of surgical operations
- A61B 17/7002: {Longitudinal elements, e.g. rods}
- A61B 34/20: Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
- G16H 50/50: for simulation or modelling of medical disorders
- G16H 50/70: for mining of medical data, e.g. analysing previous cases of other patients
- A61B 17/7001: {Screws or hooks combined with longitudinal elements which do not contact vertebrae (A61B17/7058 takes precedence)}
- A61B 17/7074: {Tools specially adapted for spinal fixation operations other than for bone removal or filler handling (A61B17/7062, A61B17/808, A61B17/8858 take precedence; for spinal image producing devices A61B90/36, A61B34/20; markers A61B90/39)}
- A61B 34/25: {User interfaces for surgical systems}
- A61B 2034/101: {Computer-aided simulation of surgical operations}
- A61B 2034/104: {Modelling the effect of the tool, e.g. the effect of an implanted prosthesis or for predicting the effect of ablation or burring}
- A61B 2034/108: {Computer aided selection or customisation of medical implants or cutting guides}
- A61B 2034/2048: {using an accelerometer or inertia sensor}
- A61B 2034/252: {indicating steps of a surgical procedure}
- A61B 2034/256: {having a database of accessory information, e.g. including context sensitive help or scientific articles}
- A61B 2090/367: {creating a 3D dataset from 2D images using position information}
- A61B 2090/376: {using X-rays, e.g. fluoroscopy}
- A61B 2090/3762: {using computed tomography systems [CT]}
- A61F 2/4657: {Measuring instruments used for implanting artificial joints (for surgical instruments A61B90/06)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)

## Abstract

The disclosure herein relate to systems, methods, and devices for developing patient-specific spinal treatments, operations, and procedures. In some embodiments, systems, methods, and devices described herein for developing patient-specific spinal treatments, operations, and procedures can comprise an iterative virtuous cycle. The iterative virtuous cycle can further comprise pre-operative, intra-operative, and post-operative techniques or processes. For example, the iterative virtuous cycle can comprise imaging analysis, case simulation, implant production, case support, data collection, machine learning, and/or predictive modeling. One or more techniques or processes of the iterative virtuous cycle can be repeated.

## Claims

### Claim 1

A system comprising:
sensors attached to two or more vertebrae of a patient, each of the sensors configured to provide position and/or orientation data of the two or more vertebrae;
one or more computer readable storage devices configured to store a plurality of computer executable instructions; and
one or more hardware computer processors in communication with the one or more computer readable storage devices and configured to execute the plurality of computer executable instructions in order to cause the system to:
receive position and/or orientation data from the sensors during a spinal surgery;
determine, based on the received data, the position and/or orientation of the two or more vertebrae;
compare the determined position and/or orientation of the two or more vertebrae with a predetermined surgical plan comprising desired position and orientation data of the two or more vertebrae, wherein the desired position and orientation data of the two or more vertebrae is determined by:
accessing one or more medical images of a preoperative spine of the patient;
accessing data related to previous spinal surgeries, the data comprising postoperative position and/or orientation data of the two or more vertebrae; and
modifying the accessed medical images to simulate an outcome of the spinal surgery for the patient; and
generate guidance instructions for performing the spinal surgery based on the comparison of the determined position and/or orientation of the two or more vertebrae with the predetermined surgical plan for the patient.

### Claim 2 (depends on 1)

The system of claim 1, wherein the sensors comprise an inertial measurement sensor with six degrees of freedom.

### Claim 3 (depends on 1)

The system of claim 1, wherein the guidance instructions comprise an audio or visual alert.

### Claim 4 (depends on 1)

The system of claim 1, wherein the accessed medical images comprise a sagittal x-ray image of the pre-operative spine of the patient.

### Claim 5 (depends on 1)

The system of claim 1, wherein the predetermined surgical plan further comprises a desired post-operative spinal curvature of the patient.

### Claim 6 (depends on 1)

The system of claim 1, wherein the system is further caused to periodically generate guidance instructions for performing the spinal surgery.

### Claim 7 (depends on 1)

The system of claim 1, wherein the system is further caused to continuously generate guidance instructions for performing the spinal surgery until a spine of the patient is adjusted to a predetermined acceptable level.

### Claim 8 (depends on 1)

The system of claim 1, wherein the accessed data related to previous spinal surgeries comprises data related to previous surgeries of one or more other patients performed prior to the spinal surgery.

### Claim 9 (depends on 1)

The system of claim 1, wherein the accessed medical images of the pre-operative spine of the patient are modified further based at least in part on one or more preferences of a surgeon performing the spinal surgery for the patient.

### Claim 10 (depends on 1)

The system of claim 1, wherein the sensors comprise one or more accelerometers and/or one or more gyroscopes.

### Claim 11 (depends on 1)

The system of claim 1, further comprising two or more attachment devices, wherein each of the two or more attachment devices comprises one or more of the sensors, a power source, and a wireless transmitter.

### Claim 12 (depends on 11)

The system of claim 11, wherein the two or more attachment devices are configured to be attached to the two or more vertebrae in a configuration such that two of three axes of position data to be collected by the sensors are on a plane assumed to be parallel, or substantially parallel with a determinate angle, to a sagittal plane of the patient.

### Claim 13 (depends on 11)

The system of claim 11, wherein the two or more attachment devices are attached to the two or more vertebrae during spinal surgery, each of the sensors configured to provide position and/or orientation data of each of the two or more vertebrae to which each of the two or more attachment devices are attached.

### Claim 14 (depends on 11)

The system of claim 11, wherein the sensors are configured to transmit the position and/or orientation data in substantially real-time.