# US 12,178,663 B2 · Systems, devices, and methods for monitoring a rod reduction process

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- Number: US 12,178,663 B2
- Document ID: US12178663B2
- Status: Granted
- Kind: B2
- Application number: 17/526,873
- Filed: 2021-11-15
- Published: 2022-06-23
- Granted: 2024-12-31
- Earliest claimed: 2020-12-17
- Assignees: Mazor Robotics Ltd.
- Applicants: Mazor Robotics Ltd.
- Inventors: Ido Zucker; Yonatan Ushpizin; Eliyahu Zehavi
- Web page: https://patentgrep.com/patent/US12178663B2

## CPC

- A61B 90/06: {Measuring instruments not otherwise provided for}
- A61B 17/7086: {Rod reducers, i.e. devices providing a mechanical advantage to allow a user to force a rod into or onto an anchor head other than by means of a rod-to-bone anchor locking element; rod removers}
- A61B 34/10: Computer-aided planning, simulation or modelling of surgical operations
- A61B 34/30: Surgical robots
- A61B 34/32: operating autonomously
- A61B 34/37: Leader-follower robots (A61B34/35 takes precedence)
- A61B 90/37: {Surgical systems with images on a monitor during operation}
- A61B 17/1671: {for the spine}
- A61B 17/7001: {Screws or hooks combined with longitudinal elements which do not contact vertebrae (A61B17/7058 takes precedence)}
- A61B 17/7091: {for applying, tightening or removing longitudinal element-to-bone anchor locking elements, e.g. caps, set screws, nuts or wedges}
- A61B 34/20: Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
- A61B 2017/00115: {with audible or visual output}
- A61B 2017/00119: {alarm; indicating an abnormal situation}
- A61B 2017/564: {Methods for bone or joint treatment}
- A61B 2034/108: {Computer aided selection or customisation of medical implants or cutting guides}
- A61B 2034/2048: {using an accelerometer or inertia sensor}
- A61B 2034/2055: {Optical tracking systems}
- A61B 2034/2059: {Mechanical position encoders}
- A61B 2090/065: {for measuring contact or contact pressure}
- A61B 2090/066: {for measuring torque}
- A61B 2090/373: {using light, e.g. by using optical scanners}
- A61B 2090/3735: {Optical coherence tomography [OCT]}
- A61B 2090/374: {NMR or MRI}
- A61B 2090/376: {using X-rays, e.g. fluoroscopy}
- A61B 2090/3762: {using computed tomography systems [CT]}
- A61B 2090/378: {using ultrasound}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Methods and systems for monitoring a rod reduction process is provided. The methods and systems include determining, based on at least one parameter, a threshold for forces exerted by a tool on a rod or a pedicle screw and receiving data corresponding to a magnitude of the forces exerted by the tool on the pedicle screw or the rod during reduction of the rod into a head of the pedicle screw. A surgical plan may be updated when the monitored magnitude meets the threshold.

## Claims

### Claim 1

A system for monitoring a rod reduction process comprising:
a tool configured to reduce a rod into a head of a pedicle screw;
at least one sensor configured to measure forces or torques exerted on the pedicle screw;
at least one processor; and
at least one memory storing instructions for execution by the at least one processor that, when executed, cause the at least one processor to:
determine, based on at least one parameter, a threshold for forces or torques exerted by the tool on the pedicle screw;
receive, from the at least one sensor, data corresponding to a magnitude of the forces or torques exerted by the tool on the pedicle screw during reduction of the rod into the head by the tool;
determine a screw quality based on the data received from the at least one sensor by calculating a change in one or more mechanical properties of the pedicle screw as a result of the forces or torques received by the pedicle screw; and
decrease the threshold when the one or more mechanical properties meets or exceeds one or more corresponding target mechanical properties.

### Claim 2 (depends on 1)

The system of claim 1, wherein the tool is handheld and operated by a user.

### Claim 3 (depends on 1)

The system of claim 1, wherein the at least one sensor is disposed on at least one of the tool or the head of the pedicle screw.

### Claim 4 (depends on 3)

The system of claim 3, wherein the at least one sensor is disposed on the tool and is integrated into the tool.

### Claim 5 (depends on 1)

The system of claim 1, wherein the at least one parameter is at least one of a screw quality, a geometry of the rod, a mechanical property of the rod, a patient range of motion, a bone quality, or a preoperative plan.

### Claim 6 (depends on 1)

The system of claim 1, wherein the at least one memory stores additional instructions for execution by the at least one processor that, when executed, further cause the at least one processor to:
update a plan for reducing the rod when the magnitude meets the threshold.

### Claim 7 (depends on 1)

The system of claim 1, further comprising:
at least one robotic arm configured to selectively implant the pedicle screw in a patient and hold the tool; and
at least one robotic sensor disposed on the robotic arm,
wherein the at least one memory stores additional instructions for execution by the at least one processor that, when executed, further cause the at least one processor to:
receive, from the at least one robotic sensor, sensor data corresponding to a force or torque exerted by the robotic arm onto the pedicle screw during implantation of the pedicle screw in the patient.

### Claim 8 (depends on 7)

The system of claim 7, wherein the at least one memory stores additional instructions for execution by the at least one processor that, when executed, further cause the at least one processor to:
cause the robotic arm to insert the rod into the patient.

### Claim 9 (depends on 7)

The system of claim 7, wherein the at least one memory stores additional instructions for execution by the at least one processor that, when executed, further cause the at least one processor to:
cause the robotic arm to operate the tool to reduce the rod onto a plurality of pedicle screws in stages, the plurality of pedicle screws including the pedicle screw.

### Claim 10 (depends on 9)

The system of claim 9, wherein reducing the rod in stages comprises causing the robotic arm to incrementally tighten, in sequence, a set screw in a head of each pedicle screw of the plurality of pedicle screws, to avoid point loading any single pedicle screw.

### Claim 11 (depends on 1)

The system of claim 1, wherein the tool is a persuader.

### Claim 12

A device for monitoring a rod reduction process comprising:
at least one processor; and
at least one memory storing instructions for execution by the at least one processor that, when executed, cause the at least one processor to:
determine a threshold, based on at least one parameter, for a force or torque exerted by a rod reduction tool during reduction of a rod into a head of each pedicle screw of one or more pedicle screws;
receive, from at least one sensor, data corresponding to a magnitude of the force or torque exerted by the rod reduction tool on the one or more pedicle screws during reduction of the rod into the head;
determine a screw quality based on the data received from the at least one sensor, wherein determining the screw quality includes calculating a change in one or more mechanical properties of each pedicle screw of the one or more pedicle screws as a result of the force or torque received by each pedicle screw of the one or more pedicle screws; and
decrease the threshold when the one or more mechanical properties meets or exceeds one or more corresponding target mechanical properties.

### Claim 13 (depends on 12)

The device of claim 12, wherein the rod reduction tool is handheld and operated by a user.

### Claim 14 (depends on 13)

The device of claim 13, wherein the at least one parameter is at least one of a screw quality, a geometry of the rod, a mechanical property of the rod, a patient range of motion, a bone quality, or a preoperative plan.

### Claim 15 (depends on 13)

The device of claim 13, wherein the at least one memory stores additional instructions for execution by the at least one processor that, when executed, further cause the at least one processor to:
update a plan for reducing the rod when the magnitude meets the threshold.

### Claim 16 (depends on 12)

The device of claim 12, wherein the at least one memory stores additional instructions for execution by the at least one processor that, when executed, further cause the at least one processor to:
cause a robotic arm to insert the rod into a patient.

### Claim 17 (depends on 12)

The device of claim 12, wherein the at least one memory stores additional instructions for execution by the at least one processor that, when executed, further cause the at least one processor to:
cause a robotic arm to operate the rod reduction tool to reduce the rod onto the one or more pedicle screws in stages.

### Claim 18 (depends on 17)

The device of claim 17, wherein reducing the rod in stages comprises causing the robotic arm to incrementally tighten, in sequence, a set screw in a head of each pedicle screw of the one or more pedicle screws, to avoid point loading any single pedicle screw.