# US 12,599,412 B2 · Intra-operative options for smart implants

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- Number: US 12,599,412 B2
- Document ID: US12599412B2
- Status: Granted
- Kind: B2
- Application number: 18/542,249
- Filed: 2023-12-15
- Published: 2024-04-18
- Granted: 2026-04-14
- Earliest claimed: 2022-04-12
- Assignees: Warsaw Orthopedic, Inc.
- Applicants: Warsaw Orthopedic, Inc.
- Inventors: Steven D. Glassman; Newton H. Metcalf, Jr.; Jerald L. Redmond; Arjun Siby-Kurian; Adam D. Glaser
- Web page: https://patentgrep.com/patent/US12599412B2

## CPC

- A61B 17/7002: {Longitudinal elements, e.g. rods}
- A61B 5/0022: {Monitoring a patient using a global network, e.g. telephone networks, internet}
- A61B 5/0031: {Implanted circuitry}
- A61B 5/4566: {Evaluating the spine (A61B5/4561 takes precedence)}
- A61B 5/4848: {Monitoring or testing the effects of treatment, e.g. of medication}
- A61B 5/686: {Permanently implanted devices, e.g. pacemakers, other stimulators, biochips (A61B5/6861 takes precedence)}
- A61B 5/6878: {Bone}
- A61B 5/742: {using visual displays (displays for heart-related electrical signals, e.g. ECG, A61B5/339)}
- A61B 17/7032: {Screws or hooks with U-shaped head or back through which longitudinal rods pass}
- A61B 17/7049: {Connectors, not bearing on the vertebrae, for linking longitudinal elements together (A61B17/7055, A61B17/7053, A61B17/7019 take precedence)}
- A61B 5/0008: {Temperature signals}
- A61B 5/01: Measuring temperature of body parts {; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue} (clinical contact thermometers G01K13/20)
- A61B 5/14539: {for measuring pH}
- A61B 2090/037: {with a frangible part, e.g. by reduced diameter}
- A61B 2090/064: {for measuring force, pressure or mechanical tension}
- A61B 2505/05: Surgical care
- A61B 2562/0271: Thermal or temperature sensors
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A method of treating a spine includes implanting at least a portion of a spinal construct in a patient. The method further includes attaching one or more smart implants to the spinal construct. Each of the one or more smart implants includes (a) an attachment portion configured to attach the smart implant to the spinal construct, and (b) at least one sensor configured to measure an aspect of the spinal construct when the smart implant is attached to the spinal construct. The method further includes receiving, from the one or more smart implants, sensor information related to the aspect of the spinal construct and performing at least one intra-operational adjustment to the spinal construct based on the received sensor information.

## Claims

### Claim 1

A method of treating a spine, the method comprising:
implanting at least a portion of a spinal construct in a patient;
attaching one or more smart implants to the spinal construct, each of the one or more smart implants comprising:
an attachment portion configured to attach the smart implant to the spinal construct; and
at least one sensor configured to measure an aspect of the spinal construct during a time that the smart implant is attached to the spinal construct, wherein the aspect comprises a force applied to one or more components of the spinal construct, and wherein the smart implant is configured to transmit information related to the measured force;
receiving, from the one or more smart implants, the transmitted sensor information related to the aspect of the spinal construct;
performing at least one intra-operational adjustment to the spinal construct based on the received sensor information by reconfiguring the construct to redistribute the forces applied to the one or more components of the spinal construct as measured by the one or more smart implants; and
removing at least one of the one or more smart implants after performing the at least one intra-operational adjustment to the spinal construct without replacing the at least one of the one or more smart implants.

### Claim 2 (depends on 1)

The method of claim 1, wherein performing the at least one intra-operational adjustment to the spinal construct comprises: bending a spinal rod of the spinal construct, adding a cross link to the spinal construct, or affixing the spinal construct to the patient at one or more additional points.

### Claim 3 (depends on 1)

The method of claim 1, wherein the one or more smart implants comprises a plurality of smart implants.

### Claim 4 (depends on 1)

The method of claim 1, wherein:
at least one smart implant comprises a force sensor;
receiving the sensor information related to the aspect of the spinal construct comprises receiving information from the force sensor; and
performing the at least one intra-operational adjustment to the spinal construct comprises performing the at least one intra-operational adjustment based on the received information from the force sensor.

### Claim 5 (depends on 4)

The method of claim 4, wherein receiving the information from the force sensor comprises receiving strain data from the force sensor.

### Claim 6 (depends on 1)

The method of claim 1, wherein:
at least one smart implant comprises a position sensor; and
receiving the sensor information related to the aspect of the spinal construct comprises receiving information related to a position of the smart implant when the smart implant is attached to the spinal construct.

### Claim 7 (depends on 1)

The method of claim 1, wherein:
at least one smart implant comprises an antenna; and
receiving the sensor information related to the aspect of the spinal construct comprises receiving the sensor information wirelessly.

### Claim 8 (depends on 1)

The method of claim 1, wherein performing the at least one intra-operational adjustment to the spinal construct comprises implanting additional construct components.

### Claim 9 (depends on 1)

The method of claim 1, wherein attaching the one or more smart implants to the spinal construct comprises:
adding a provisional component to the spinal construct; and
attaching at least one of the one or more smart implants to the provisional component.

### Claim 10 (depends on 9)

The method of claim 9, further comprising attaching the at least one of the one or more smart implants to a part of the patient's anatomy.

### Claim 11 (depends on 9)

The method of claim 9, further comprising, after performing the at least one intra-operational adjustment to the spinal construct, removing the provisional component.

### Claim 12 (depends on 1)

The method of claim 1, wherein:
the spinal construct comprises a spinal rod; and
attaching the one or more smart implants to the spinal construct comprises securing the spinal rod within an opening of at least one of the one or more smart implants.

### Claim 13 (depends on 1)

The method of claim 1, further comprising attaching at least one of the one or more smart implants to a part of the patient's anatomy.

### Claim 14 (depends on 13)

The method of claim 13, wherein:
the at least one of the one or more smart implants comprises a bone screw; and
attaching the at least one of the one or more smart implants to the part of the patient's anatomy comprises attaching the at least one of the one or more smart implants to a bone using the bone screw.

### Claim 15 (depends on 13)

The method of claim 13, further comprising, after performing the at least one intra-operational adjustment to the spinal construct, detaching the at least one of the one or more smart implants from the part of the patient's anatomy without reattaching the at least one of the one or more smart implants.

### Claim 16 (depends on 1)

The method of claim 1, wherein receiving the sensor information related to the aspect of the spinal construct comprises receiving the sensor information by an external reader device.

### Claim 17 (depends on 16)

The method of claim 16, wherein receiving the sensor information related to the aspect of the spinal construct comprises viewing a plot of the sensor information displayed by the external reader device.

### Claim 18 (depends on 16)

The method of claim 16, wherein receiving the sensor information related to the aspect of the spinal construct comprises receiving a notification, from the external reader device, that one or more sensor measurements are outside of a value range.

### Claim 19 (depends on 1)

The method of claim 1, wherein performing the at least one intra-operational adjustment to the spinal construct comprises extending the construct to include additional spinal levels.

### Claim 20 (depends on 1)

The method of claim 1, wherein reconfiguring the construct to redistribute the forces applied to the one or more components of the spinal construct comprises bending and/or contouring a spinal rod to increase or decrease a force measured by at least one of the one or more smart implants.

### Claim 21

A method of treating a spine, the method comprising:
implanting at least a portion of a spinal construct in a patient;
attaching one or more smart implants to the spinal construct, each of the one or more smart implants comprising:
an attachment portion configured to attach the smart implant to the spinal construct; and
at least one sensor configured to measure an aspect of the spinal construct during a time that the smart implant is attached to the spinal construct, wherein the aspect comprises a force applied to one or more components of the spinal construct, and wherein the smart implant is configured to transmit information related to the measured force;
attaching at least one of the one or more smart implants to a part of the patient's anatomy;
receiving, from the one or more smart implants, the transmitted sensor information related to the aspect of the spinal construct;
performing at least one intra-operational adjustment to the spinal construct based on the received sensor information by reconfiguring the construct to redistribute the forces applied to the one or more components of the spinal construct as measured by the one or more smart implants; and
after performing the at least one intra-operational adjustment to the spinal construct, detaching the at least one of the one or more smart implants from the part of the patient's anatomy without reattaching the at least one of the one or more smart implants.
