# US 2021/0330970 A1 · Functional electrical stimulation ergometer including automatic spasm control

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 2021/0330970 A1
- Document ID: US20210330970A1
- Status: Published application
- Kind: A1
- Application number: 17/113,697
- Filed: 2020-12-07
- Published: 2021-10-28
- Earliest claimed: 2016-11-04
- Assignees: Restorative Therapies, Inc.
- Applicants: Restorative Therapies, Inc.
- Inventors: Michael DUNCAN
- Web page: https://patentgrep.com/patent/US20210330970A1

## CPC

- A61N 1/36003: {of motor muscles, e.g. for walking assistance}
- A61B 5/11: Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb {(A61B5/1038 takes precedence; motion detection to correct for motion artifacts in physiological signals A61B5/721)}
- A61N 1/36014: {External stimulators, e.g. with patch electrodes (external pacemakers A61N1/3625)}
- A61N 1/37288: {Communication to several implantable medical devices within one patient}
- A61B 5/1101: {Detecting tremor}
- A61N 1/18: Applying electric currents by contact electrodes
- A61N 1/32: alternating or intermittent currents {(applying electric fields by inductive or capacitive coupling A61N1/40; microwave apparatus A61N5/02)}
- A61N 1/36: for stimulation
- A61N 1/3603: {Control systems}
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

This invention controls stimulation levels and cycling cadence on an FES ergometer to minimize or prevent the occurrence of spasm in spinal cord injured or other neurologically impaired patients.

## Claims

### Claim at position 1

1-13. (canceled)

### Claim 14

A system, comprising:
an extremity support configured to receive an upper or lower extremity of a subject;
a motor assembly configured to control a speed and direction of reciprocal motion of the extremity support via a crank;
a control unit operatively coupled to the motor assembly and configured to control the motor assembly to cause the extremity support to move the upper or lower extremity of the subject, the control unit including functional electrical stimulation leads configured to be coupled to the subject such that electrical stimulation can be delivered to muscles of the patient via the functional electrical stimulation leads; and
an automatic spasm control system configured to:
continuously monitor a torque required for the motor assembly to move the extremity support and to calculate a rate of change of the torque,
identify that a monitored amount of torque required for the motor assembly to move the extremity support or a rate of change of torque required for the motor assembly to move the extremity support exceeds a predetermined value, and
in response to identifying that the monitored amount of torque or the rate of change of torque exceeds the predetermined value, send instructions to the control unit to change at least one of a speed of the crank while maintaining a direction of reciprocal motion of the extremity support or to change an amount of electrical stimulation delivered via the functional electrical stimulation leads while continuing to deliver electrical stimulation.

### Claim 15 (depends on 14)

The system of claim 14, wherein the automatic spasm control system is further configured to calculate a maximum speed of the crank, a maximum ramp-up rate of the crank, a maximum electrical stimulation, and a maximum stimulation ramp-up rate to prevent at least one of a muscle tone of the subject from increasing or a spasm of the subject from occurring.

### Claim 16 (depends on 14)

The system of claim 14, wherein the automatic spasm control system is further configured to:
calculate a maximum electrical stimulation to prevent at least one of a muscle tone of the subject from increasing or a spasm of the subject from occurring, and
compare a current level of electrical stimulation to the calculated maximum electrical stimulation, the instructions including instructions to reduce the amount of electrical stimulation delivered via the functional electrical stimulation leads if the current level of electrical stimulation is higher than the calculated maximum electrical stimulation

### Claim 17 (depends on 14)

The system of claim 14, wherein the automatic spasm control system is further configured to:
calculate a maximum electrical stimulation to prevent at least one of a muscle tone of the subject from increasing or a spasm of the subject from occurring, and
compare a current level of electrical stimulation to the calculated maximum electrical stimulation, the instructions including instructions to increase the amount of electrical stimulation delivered via the functional electrical stimulation leads at a rate equal to or less than the maximum stimulation ramp-up rate if the current level of electrical stimulation is lower than the calculated maximum electrical stimulation.

### Claim 18 (depends on 14)

The system of claim 14, wherein the automatic spasm control system is further configured to:
calculate a maximum speed of the crank to prevent at least one of a muscle tone of the subject from increasing or a spasm of the subject from occurring,
compare a current crank speed to the calculated maximum speed of the crank, the instructions including instructions to reduce the speed of the crank if the current crank speed is higher than the calculated maximum speed of the crank.

### Claim 19 (depends on 14)

The system of claim 14, wherein the automatic spasm control system is further configured to:
calculate a maximum speed of the crank to prevent at least one of a muscle tone of the subject from increasing or a spasm of the subject from occurring,
compare a current crank speed to the calculated maximum speed of the crank, the instructions including instructions to increase the speed of the crank at a rate equal to or less than the maximum ramp-up rate of the crank if the current crank speed is lower than the calculated maximum speed of the crank.

### Claim 20 (depends on 15)

The system of claim 15, wherein, if, after the automatic spasm control system sends the instructions, an amount of muscle tone of the subject increases, the automatic spasm control system is configured to reduce at least one of the maximum speed of the crank, the maximum ramp-up rate of the crank, the maximum electrical stimulation, or the maximum stimulation ramp-up rate.

### Claim 21 (depends on 15)

The system of claim 15, wherein, if, after the automatic spasm control system sends the instructions, an amount of muscle tone of the subject reduces, the automatic spasm control system increases at least one of the maximum speed of the crank, the maximum ramp-up rate of the crank, the maximum electrical stimulation, and the maximum stimulation ramp-up rate.

### Claim 22 (depends on 15)

The system of claim 15, wherein, if, after the automatic spasm control system sends the instructions, the amount of muscle tone of the subject does not decrease over a predetermined period of time, the automatic spasm control system increases the maximum crank speed and maximum electrical stimulation.

### Claim 23

A system, comprising:
an extremity support configured to receive an upper or lower extremity of a subject;
a motor assembly configured to control a speed and direction of reciprocal motion of the extremity support via a crank;
a control unit operatively coupled to the motor assembly and configured to control the motor assembly to cause the extremity support to move the upper or lower extremity of the subject, the control unit including functional electrical stimulation leads configured to be coupled to the subject such that electrical stimulation can be delivered to muscles of the patient via the functional electrical stimulation leads; and
an automatic spasm control system configured to detect muscle tone by continuously monitoring a torque required for the motor assembly to move the extremity support and calculating a rate of change of the torque, the automatic spasm control system configured to calculate, for each of a plurality of amounts of muscle tone of the subject detected by the automatic spasm control system, a maximum crank speed and a maximum electrical stimulation,
the automatic spasm control system configured to:
detect an amount of muscle tone from the plurality of amounts of muscle tone of the subject by identifying that a monitored amount of torque required to rotate the extremity support or a rate of change of torque required to rotate the extremity support exceeds a predetermined value, and
in response to detecting the amount of muscle tone from the plurality of amounts of muscle tone, compare at least one of a current crank speed to the calculated maximum crank speed associated with the amount of muscle tone or a current level of electrical stimulation to the calculated maximum electrical stimulation associated with the amount of muscle tone.

### Claim 24 (depends on 23)

The system of claim 23, wherein, if the current crank speed is higher than the calculated maximum crank speed associated with the amount of muscle tone, the automatic spasm control system is further configured to send instructions to the control unit to reduce a speed of the crank.

### Claim 25 (depends on 23)

The system of claim 23, wherein the automatic spasm control system is configured to calculate, for each of the plurality of amounts of muscle tone of the subject detected by the automatic spasm control system, a maximum crank ramp-up rate, and, if the current crank speed is lower than the calculated maximum crank speed associated with the amount of muscle tone, the automatic spasm control system is further configured to send instructions to the control unit to increase the speed of the crank at a rate equal to or less than the maximum crank ramp-up rate associated with the amount of muscle tone.

### Claim 26 (depends on 23)

The system of claim 23, wherein, if the current level of electrical stimulation is higher than the calculated maximum electrical stimulation associated with the amount of muscle tone, the automatic spasm control system is further configured to send instructions to the control unit to reduce the amount of electrical stimulation delivered via the functional electrical stimulation leads.

### Claim 27 (depends on 23)

The system of claim 23, wherein the automatic spasm control system is configured to calculate, for each of the plurality of amounts of muscle tone of the subject detected by the automatic spasm control system, a maximum stimulation ramp-up rate, and, if the current level of electrical stimulation is lower than the calculated maximum electrical stimulation associated with the amount of muscle tone, the automatic spasm control system is further configured to send instructions to the control unit to increase the amount of electrical stimulation delivered via the functional electrical stimulation leads at a rate equal to or less than the calculated maximum stimulation ramp-up rate associated with the amount of muscle tone.

### Claim 28

A method, comprising:
continuously monitoring a torque required for a motor assembly to move an extremity support coupled to the motor assembly via a crank, the extremity support configured to receive an upper or lower extremity of a subject;
calculating a rate of change of the torque;
identifying that a monitored amount of torque required for the motor assembly to move the extremity support or a rate of change of torque required for the motor assembly to move the extremity support exceeds a predetermined value, and
in response to identifying that the monitored amount of torque or the rate of change of torque exceeds the predetermined value, sending instructions to a control unit operatively coupled to the motor assembly to change at least one of a speed of the crank while maintaining a direction of reciprocal motion of the extremity support or to change an amount of electrical stimulation delivered via the functional electrical stimulation leads while continuing to deliver electrical stimulation.

### Claim 29 (depends on 28)

The method of claim 28, further comprising:
calculating a maximum speed of the crank, a maximum ramp-up rate of the crank, a maximum electrical stimulation, and a maximum stimulation ramp-up rate to prevent at least one of a muscle tone of the subject from increasing or a spasm of the subject from occurring.

### Claim 30 (depends on 28)

The method of claim 28, further comprising:
calculating a maximum electrical stimulation to prevent at least one of a muscle tone of the subject from increasing or a spasm of the subject from occurring, and
comparing a current level of electrical stimulation to the calculated maximum electrical stimulation, the instructions including instructions to reduce the amount of electrical stimulation delivered via the functional electrical stimulation leads if the current level of electrical stimulation is higher than the calculated maximum electrical stimulation.

### Claim 31 (depends on 28)

The system of claim 28, further comprising:
calculating a maximum electrical stimulation to prevent at least one of a muscle tone of the subject from increasing or a spasm of the subject from occurring, and
comparing a current level of electrical stimulation to the calculated maximum electrical stimulation, the instructions including instructions to increase the amount of electrical stimulation delivered via the functional electrical stimulation leads at a rate equal to or less than the maximum stimulation ramp-up rate if the current level of electrical stimulation is lower than the calculated maximum electrical stimulation.

### Claim 32 (depends on 28)

The system of claim 28, further comprising:
calculating a maximum speed of the crank to prevent at least one of a muscle tone of the subject from increasing or a spasm of the subject from occurring, and
comparing a current crank speed to the calculated maximum speed of the crank, the instructions including instructions to reduce the speed of the crank if the current crank speed is higher than the calculated maximum speed of the crank.

### Claim 33 (depends on 28)

The system of claim 28, further comprising:
calculating a maximum speed of the crank to prevent at least one of a muscle tone of the subject from increasing or a spasm of the subject from occurring,
comparing a current crank speed to the calculated maximum speed of the crank, the instructions including instructions to increase the speed of the crank at a rate equal to or less than the maximum ramp-up rate of the crank if the current crank speed is lower than the calculated maximum speed of the crank.
