# US 10,478,121 B2 · Device and method for determining an incorrect positioning in the alignment of prostheses

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- Number: US 10,478,121 B2
- Document ID: US10478121B2
- Status: Granted
- Kind: B2
- Application number: 14/401,400
- Filed: 2013-05-14
- Published: 2015-05-14
- Granted: 2019-11-19
- Earliest claimed: 2012-05-14
- Assignees: Ottobock SE & Co. Kgaa
- Applicants: Otto Bock Healthcare GmbH
- Inventors: Martin Pusch
- Web page: https://patentgrep.com/patent/US10478121B2

## CPC

- A61B 5/4851: {Prosthesis assessment or monitoring}
- A61B 5/112: {Gait analysis}
- A61B 5/1121: {Determining geometric values, e.g. centre of rotation or angular range of movement}
- A61B 5/1122: {of movement trajectories}
- A61B 5/4571: {Evaluating the hip}
- A61B 5/4585: {Evaluating the knee}
- A61B 5/7405: {using sound}
- A61B 5/742: {using visual displays (displays for heart-related electrical signals, e.g. ECG, A61B5/339)}
- A61B 5/746: {Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A method and a device for determining an incorrect positioning in the alignment of prostheses for the lower extremities are disclosed. The method includes determining inertial measurement data and/or variables derived therefrom using at least one inertial sensor, over at least one walking cycle, for an extremity provided with a prosthesis. The method also includes comparing the inertial measurement data that has been determined and/or the variables derived therefrom with desired values and/or with measurement data that has been determined or variables derived therefrom for the corresponding extremity that is not provided with the prosthesis.

## Claims

### Claim 1

A method for determining positions for alignment of a prosthetic foot relative to a lower leg tube as part of an alignment of a lower extremity device, comprising:
establishing, using sensor data measured by at least one inertial sensor connected to the lower extremity device, over at least one gait cycle for a treated extremity, at least one of inertial measurement data and variables derived from the inertial measurement data for the treated extremity, the inertial measurement data comprising absolute angles of a lower leg and a thigh of the treated extremity;
determining a knee angle of the lower leg and the thigh from the absolute angles of the lower leg and thigh;
comparing the inertial measurement data and the knee angle with intended values;
determining positions for alignment of the prosthetic foot relative to the lower leg tube based on the comparing.

### Claim 2 (depends on 1)

The method as claimed in claim 1, further comprising establishing at least one of inertial measurement data and variables derived from the inertial measurement data for an untreated extremity.

### Claim 3 (depends on 1)

The method as claimed in claim 1, further comprising outputting a deviation message when an established angle deviates from the at least one of intended values, established measurement data, and derived variables for the untreated extremity, or outputting a confirmation message when the established angle is within the at least one of intended values, established measurement data, and derived variables for the untreated extremity.

### Claim 4 (depends on 1)

The method as claimed in claim 1, further comprising establishing a pelvic angle in a frontal plane using the at least one inertial angle sensor, and outputting an error message if the pelvic angle exceeds a limit value.

### Claim 5 (depends on 1)

The method as claimed in claim 1, wherein the inertial measurement data is established over a plurality of gait cycles.

### Claim 6

A device for determining positions for alignment of a prosthetic foot relative to a lower leg tube as part of an alignment of a lower extremity prosthesis, the device comprising:
a lower extremity prosthesis having a component;
at least one inertial sensor arranged on the component, the at least one inertial sensor measuring inertial measurement data, the inertial measurement data comprising absolute angles of a lower leg and a thigh of the treated extremity, the absolute angles of the lower leg and thigh being used to determine a knee angle;
a comparator coupled to the at least one inertial sensor, the comparator being configured to compare the inertial measurement data and the knee angle to intended values, the comparison being used to determining positions for alignment of the prosthetic foot relative to the lower leg tube.

### Claim 7 (depends on 6)

The device as claimed in claim 6, further comprising at least one additional inertial sensor configured to be arranged on an untreated extremity, the at least one additional inertial sensor connected to the comparator.

### Claim 8

A method for determining positions for alignment of a prosthetic foot relative to a lower leg tube as part of an alignment of a lower extremity device that is operable on a treated extremity of a user, the method comprising:
providing at least one inertial sensor and a lower extremity device;
determining inertial measurement data and variables for the treated extremity using the at least one inertial sensor over at least one gait cycle during use of the lower extremity device, the variables including a knee angle;
comparing the inertial measurement data and the variables with intended values;
determining positions for alignment of the prosthetic foot relative to the lower leg tube based on the comparing.

### Claim 9 (depends on 8)

The method as claimed in claim 8, further comprising:
measuring absolute angles as the inertial measurement data, the absolute angles being used to determine the knee angle.

### Claim 10 (depends on 8)

The method as claimed in claim 8, further comprising:
establishing at least one of inertial measurement data and variables derived from the inertial measurement data on an untreated extremity.

### Claim 11 (depends on 8)

The method as claimed in claim 8, wherein the lower extremity device comprises a lower leg and a thigh, the lower leg and the thigh each having absolute angles, the method further comprising:
determining the knee angle from the absolute angles of the lower leg and of the thigh;
comparing the knee angle to intended knee angle values.

### Claim 12 (depends on 8)

The method as claimed in claim 8, further comprising:
establishing an angle of the lower extremity device;
outputting a deviation message when the angle of the lower extremity device deviates from the intended values, or outputting a confirmation message when the established angle is within the intended values.

### Claim 13 (depends on 8)

The method as claimed in claim 8, further comprising:
establishing a pelvic angle in a frontal plane by using the at least one inertial angle sensor;
outputting an error message if the pelvic angle exceeds a limit value.

### Claim 14 (depends on 8)

The method as claimed in claim 8, further comprising:
establishing the inertial measurement data over a plurality of gait cycles.

### Claim 15 (depends on 1)

The method as claimed in claim 1, wherein the lower extremity device is a prosthesis.

### Claim 16 (depends on 8)

The method as claimed in claim 8, wherein the lower extremity device is a prosthesis.

### Claim 17 (depends on 1)

The method as claimed in claim 1, further comprising:
providing a recommendation for adjustment of the lower extremity device based on the comparison of the knee angle with the intended values; and
adjusting an alignment setting of the lower extremity device based on the recommendation.

### Claim 18 (depends on 1)

The method of claim 1, wherein the inertial measurement data further comprises at least one of linear accelerations of the lower extremity device and angular rates or angular velocities of the lower extremity.

### Claim 19 (depends on 6)

The device as claimed in claim 6, further comprising an acoustic or optical output device in electronic communication with the comparator, the acoustic or optical output device being configured to output at least one of the intended values and a deviation message, and to output at least one recommendation for adjustment of an alignment setting of the lower extremity device based on the comparison performed by the comparator.
